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- More evidence ties acne drug to bowel disease
- Reuters - An excerpt from the article states that "(Reuters Health) - Adding to evidence that the acne drug isotretinoin may lead to bowel disease in some users, a new study finds that patients on the medication were four times more likely than non-users to develop ulcerative colitis within a year.Reporting in the American Journal of Gastroenterology, researchers say that the risk of any one isotretinoin user developing ulcerative colitis is "likely quite small."
However, the findings do strengthen the evidence of a cause-and-effect relationship between the acne drug and inflammatory bowel disease (IBD) -- a group of digestive disorders that includes ulcerative colitis and Crohn's disease.Isotretinoin, which is used to treat severe acne, is probably best known by the brand-name Accutane. That drug was taken off the market last year in the face of competition from generic alternatives -- though in pulling the medication, maker Roche Pharmaceuticals also cited costs from defending personal-injury lawsuits.
Earlier this year, the company was ordered to pay $25 million in damages to a former Accutane user who claimed that the drug caused his IBD.
The company has maintained that there is no strong evidence that the acne drug triggers IBD. Between 1997 and 2002, 83 cases of IBD among isotretinoin users were reported to the U.S. Food and Drug Administration, but that does not prove that the drug itself is to blame.
For the new study, Dr. Seth D. Crockett and colleagues at the University of North Carolina Chapel Hill tried to test the cause-and-effect relationship."...... keywords: accutane, IBD, chron's, colitis, bowel disease, inflammatory bowel disease -
- Rosiglitazone and the Case for Safety Over Certainty
- JAMA - An excerpt from the article states that "Approximately 10 years ago, the thiazolidinediones rosiglitazone and pioglitazone were introduced for the treatment of type 2 diabetes. Like their forerunner troglitazone, which was removed from the market following reports of hepatotoxicity, these drugs act on the gamma subtype of peroxisome proliferator-activated receptors (PPAR-) in the cell nucleus, resulting in heightened insulin sensitivity and improved glycemic control.1 Because insulin resistance is a common feature of type 2 diabetes, the biological effects of thiazolidinediones made these drugs appealing to patients with diabetes and to their physicians who were looking for yet another way to avoid the need for insulin. Within a few years, both drugs became multibillion-dollar products despite no direct evidence that they actually prevented the complications of diabetes.As the popularity of rosiglitazone and pioglitazone increased, reports surfaced of peripheral edema and congestive heart failure during treatment.2 It quickly became apparent that these medications could cause both conditions, which are now thought to result from activation of PPAR- in the distal nephron, leading to increased reabsorption of sodium and water.3 The lesson here is that pharmacological tinkering with a nuclear receptor is likely to have consequences anywhere that receptor is expressed.In May 2007, safety concerns regarding the thiazolidinediones attracted widespread attention with the publication of a meta-analysis suggesting that, compared with other treatments for diabetes, rosiglitazone was associated with a 43% higher risk of myocardial infarction (P = .03) and a 64% higher risk of cardiovascular death (P = .06).4 Several other meta-analyses involving rosiglitazone followed, and while their methods and conclusions varied, these reports provided a relatively consistent message that rosiglitazone might indeed increase the risk of myocardial ischemic events, albeit with an inconsistent message regarding mortality.5 In contrast, a meta-analysis of 19 trials involving pioglitazone suggested that even though the drug appeared to increase the risk of heart failure, it might reduce the risk of myocardial infarction, stroke, or death.6Along with these meta-analyses, several large-scale pharmacoepidemiologic investigations have used health care databases to provide "real-world" data on the safety of the thiazolidinediones.5 While some of these studies were more rigorous than others and several did not specifically focus on the comparative safety of rosiglitazone and pioglitazone, studies in which these drugs were compared consistently showed that rosiglitazone was associated with greater risk than pioglitazone, or at best, the risks associated with these drugs were not statistically different. "...... keywords: Heart Attack | MI | Cardiovascular (heart) Failure | Bone Fracture | Stroke | Ischemic Stroke | Cardiac Related Death | -
- Supreme Court Strikes Down Part of Sarbanes-Oxley Law - Law.com - An excerpt from the article states that "The Supreme Court on Monday struck down part of the anti-fraud law enacted in response to Enron and other corporate scandals from the early 2000s, but said its decision has limited consequences.The justices voted 5-4 that the Sarbanes-Oxley law enacted in 2002 violates the Constitution's separation of powers mandate. The Court says the president must be able to remove members of a board that was created to tighten oversight of internal corporate controls and outside auditors."What this means going forward is twofold: that corporate lawyers should have the confidence to continue to focus their clients on compliance with the sweeping reforms contained in Sarbox," Association of Corporate Counsel general counsel Susan Hackett said in a statement in response to the ruling."...... keywords:
- After High Court's Bilski Ruling, Business (Almost) as Usual - Law.com - An excerpt from the article states that "In the last batch of opinions to which he will ever contribute, retiring U.S. Supreme Court Justice John Paul Stevens fell one vote shy in his goal of moving methods of doing business outside the scope of the country’s patent system. And he marked the occasion by weighing in with a concurring opinion that reads an awful lot like a dissent. Ultimately, despite widespread speculation that Stevens would cap his distinguished career by writing the majority opinion in Bilski v. Kappos, Justice Anthony Kennedy wound up as the author of the controlling opinion in the closely watched patent case.While all nine justices agreed that the “invention” at issue in the case—a method for hedging weather-related risk in energy trading developed by Bernard Bilski and Rand Warsaw—was too abstract to merit patent protection, only four signed on fully to Kennedy’s opinion. That opinion held that the "machine-or-transformation" test for patentability-- created by the U.S. Court of Appeals for the Federal Circuit in its Bilski decision-- was a "useful clue" when gauging a subject’s patentability but shouldn't be considered the only applicable test. "...... keywords: patent, patent litigation, patent infringement, intellectual property -
- Mystery Unraveled: How Asbestos Causes Cancer
HMGB1 Protein Starts an Inflammatory Reaction that Promotes Tumor Growth - University of Hawaii System - An excerpt from the article states that "More than 20 million people in the U.S., and many more worldwide, who have been exposed to asbestos are at risk of developing mesothelioma, a malignant cancer of the membranes that cover the lungs and abdomen that is resistant to current therapies. Moreover, asbestos exposure increases the risk of lung cancer among smokers. For the past 40 years researchers have tried to understand why asbestos causes cancer. The answer appears in a study published in the current issue of the Proceedings of the National Academy of Sciences, U.S.A., Drs. Haining Yang and Michele Carbone at the University of Hawai‘i Cancer Research Center led a research team that included collaborators at New York University, University of Chicago, University of Pittsburgh, San Raffaele University of Milano, and the Imperial College in London.These researchers addressed the paradox of how asbestos fibers that kill cells could cause cancer, since a dead cell should not be able to grow and form a tumor. They found that when asbestos kills cells, it does so by inducing a process called “programmed cell necrosis” that leads to the release of a molecule called high-mobility group box 1 protein (HMGB1). HMGB1 starts a particular type of inflammatory reaction that causes the release of mutagens and factors that promote tumor growth. The researchers found that patients exposed to asbestos have elevated levels of HMGB1 in their serum. Therefore, they state that it may be possible to target HMGB1 to prevent or treat mesothelioma and identify asbestos-exposed cohorts by simple HMGB1 serological testing.
"...... keywords: mesothelioma, asbestos, asbestos-related cancer, cancer -
- Merck hit with $8 million verdict in Fosamax trial - Herald Online - An excerpt from the article states that "Drugmaker Merck & Co. said it will challenge its first loss in a trial blaming its osteoporosis drug for destroying a patient's jawbone after a federal jury on Friday awarded $8 million to the Florida woman.The U.S. District Court jury in New York awarded that amount in compensatory damages to Shirley Boles, 72, of Fort Walton, Fla., who alleged Merck's Fosamax destroyed her jawbone near her ears, causing serious pain and disability."...... keywords:fosamax, osteonecrosis, jaw death, jaw bone death, jaw bone, bisphosphonates -
- Crib recall: 2 million more - CNN - An excerpt from the article states that "NEW YORK (CNNMoney.com) -- Another 2 million cribs are being recalled due to the drop-side hazard, the culprit in millions of other crib recalls over the last few years.Thursday's announcement is part of a wider program, in which the U.S. Consumer Product Safety Commission has announced the recall of nine million drop-side cribs, which are considered riskier than four-sided cribs because they pose a risk of trapping and suffocating a small child.In its latest recall, the commission said the cribs were manufactured by seven companies between 2000 and 2009. It said free repair kits will be provided to consumers "to immobilize the drop sides" over the next few weeks.""...... keywords: -
- Judge sides with Google in $1 billion Viacom case - SJ Mercury - An excerpt from the article states that "A federal judge on Wednesday found in favor of Google in a $1 billion copyright lawsuit filed by Viacom over videos posted on YouTube, a case that legal experts said could have dramatically altered the rules for user-posted videos, music and other content on the Web had the ruling gone the other way.
Instead, Judge Louis Stanton of New York delivered a summary judgment that essentially endorses current practices, finding that YouTube was in line with the federal Digital Millennial Copyright Act (DMCA) when it promptly removed copyrighted videos from cable channels like Comedy Central and Nickelodeon when it was notified by Viacom.Viacom said it would appeal the decision as soon as possible, calling it "fundamentally flawed," but the lower court ruling for now hands a big victory to Google and by extension to other social sites like Facebook, where millions of people share video clips, digital music files or other types of copyright-protected content with their friends.
"What's at stake is the current state of play in user-generated content space," said Eric Goldman, director of the High Tech Law Institute at Santa Clara University. "If the court had said otherwise, nobody knows what would have happened. It could have resulted in having to re-engineer current industry practices. The stakes on that front were extremely high.""...... keywords: (Copyright, copyright litigation, intellectual property litigation) -
- Name Choices Spark Lawsuits - WSJ - An excerpt from the article states that "Jimmy Winkelmann started a clothing company several years ago to mock fellow students who wore the outdoorsy The North Face brand, despite having no inclination to venture into the wilderness. He dubbed his company "The South Butt" and flipped The North Face's half-dome logo to look like buttocks. But at least one party wasn't amused: The North Face. Mr. Winkelmann, now a student at the University of Missouri at Columbia, received a cease-and-desist letter from the company last summer. He declined to comply, prompting a trademark infringement suit that was settled out of court in April.The South Butt is still in operation. Mr. Winkelmann's lawyer and a spokeswoman for The North Face, a unit of VF Corp., said the matter was resolved amicably, but declined to comment further. It's unclear if Mr. Winkelmann is required to make any payments to The North Face or if the company has imposed any conditions on his marketing efforts.Small businesses, unwittingly or not, have a history of running into scuffles by playing off a larger company's protected trademarks—sometimes resulting in legal battles they can ill afford, given the limited resources of most start-up operations. Some 3,500 trademark cases are filed each year in U.S. district courts, according to FTI Consulting Inc., a Baltimore advisory firm that tracks intellectual-property statistics."...... keywords: (Copyright, copyright litigation, intellectual property litigation) -
- Teva Announces Launch of Generic Yaz® Tablets - TEVA - An excerpt from the article states that "Jerusalem, June 1, 2010 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that it has commercially launched Gianvi (Drospirenone and Ethinyl Estradiol) Tablets, the Company's generic version of Bayer's Yaz® Tablets. Total sales of Yaz® Tablets were approximately $782 million in the United States, for the twelve months that ended December 31, 2009, based on IMS sales data.As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.As previously announced, Teva has the right to launch an authorized generic version of the product, supplied by Bayer, in July 2011."...... keywords: yaz, yasmin, generic -
- The pros and cons of Prolia, Amgen's new osteoporosis drug - LA Times - An excerpt from the article states that "The U.S. Food and Drug Administration approved a new drug for osteoporosis this month. Amgen's Prolia (denosumab) prevents fractures in postmenopausal women at a rate similar to the most popular drugs on the market — bisphosphonates such as Fosamax, Actonel, Boniva and Reclast.Doctors say this is good news because Prolia differs radically from Fosamax and its cousins, offering a good alternative for patients who can't take bisphosphonates. "This was somewhat of a breakthrough in that it's a completely different mechanism and a completely different chemical compound," says Dr. Aurelia Nattiv, who directs the UCLA Osteoporosis Center.But no one thinks the new drug will replace bisphosphonates in treating osteoporosis. Nattiv (who has no current financial ties to companies making osteoporosis drugs) warns that the drug's newness means that the full suite and frequency of serious side effects is yet to be determined. Bisphosphonate drugs, in contrast, have been marketed in the U.S. since 1995, so their risks are better known. "We still need to take caution and make sure we carefully select patients" to start on Prolia, Nattiv says."...... keywords: ostenecrosis, fosamax, jaw bone death-
- Research In Motion, Motorola Settle Smartphone Patent Dispute - WSJ - An excerpt from the article states that "Blackberry maker Research In Motion Ltd. and Motorola Inc. settled a patent dispute over key technology found in their smartphones, with RIM agreeing to make a one-time payment and ongoing royalties in exchange for a halt to the litigation."...... keywords:-
- Five lots of Benadryl, Tylenol added to drug recall - CNN - An excerpt from the article states that "(CNN) -- The maker of Benadryl and Tylenol has added five lots of the popular over-the-counter drugs to its growing list of recalled products, McNeil Consumer Healthcare announced Wednesday in a written statement.Saying the drugs were "inadvertently omitted from the initial recall action" of January 15, McNeil disclosed it was voluntarily recalling four lots of Benadryl Allergy Ultratab Tablets (100 count) and one lot of Extra Strength Tylenol Rapid Release Gels (50 count).The Johnson and Johnson subsidiary said customers should call 1-888-222-6036 or use the website www.mcneilproductrecall.com for information on how to receive a refund or replacement product. The drugs were sold in the United States and in Bermuda, Puerto Rico, Trinidad and Tobago.McNeil said the "risk of adverse medical events is remote." Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the U.S. Food and Drug Administration. Adverse events could include death, hospitalization, disability and other health complications.The products were recalled because of an unusual odor associated with the chemical 2,4,6-tribromoanisole (TBA) that was applied to shipping pallets, the company said.McNeil's other recalls in the past eight months were:"...... keywords:-
- More Buzz on Vuvuzela: It's a Health Risk, Too - WSJ - An excerpt from the article states that "JOHANNESBURG—Doctors and hearing experts warned that vuvuzelas, the blaring plastic horns favored by South African soccer fans, can cause hearing loss and possibly spread colds, the flu and other infectious diseases to spectators in stadiums, as broadcasters are screening out the noise for viewers at home.Traditionally made from the horn of a kudu, a species of antelope found in the African bush, the vuvuzela was once used to call people together across distances. Today, plastic variations are a soccer-fan fixture, used to distract opposing teams and cheer on one's own—with roughly the same loud blare.Beyond the stadiums, the horns can be heard from early morning to late at night on South Africa's streets during the World Cup. South African newspapers have reported workplace clashes involving employees blowing the horn. They have caused conflict among bus and train passengers as well."...... keywords:-
- Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia - NEJM - An excerpt from the article states that "Background Nilotinib has been shown to be a more potent inhibitor of BCR-ABL than imatinib. We evaluated the efficacy and safety of nilotinib, as compared with imatinib, in patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase.Methods In this phase 3, randomized, open-label, multicenter study, we assigned 846 patients with chronic-phase Philadelphia chromosome–positive CML in a 1:1:1 ratio to receive nilotinib (at a dose of either 300 mg or 400 mg twice daily) or imatinib (at a dose of 400 mg once daily). The primary end point was the rate of major molecular response at 12 months."...... keywords:-
- FDA Extends Review of Gardasil's Use by Older Women - WSJ - An excerpt from the article states that "The Food and Drug Administration has extended its review of Merck & Co.'s application to broaden the use of its cervical-cancer vaccine, Gardasil, to include older women."...... keywords:-
- $300 mln to cope with Agent Orange in Vietnam - AP - An excerpt from the article states that " HANOI, Vietnam (AP) -- Thirty-five years after the Vietnam War, a $300 million price tag has been placed on the most contentious legacy still tainting U.S.-Vietnam relations: Agent Orange.A joint panel of U.S. and Vietnamese policymakers, citizens and scientists released an action plan Wednesday, urging the U.S. government and other donors to provide an estimated $30 million annually over 10 years to clean up sites still contaminated by dioxin, a toxic chemical used in the defoliant.The funding would also be used to treat Vietnamese suffering from disabilities, including those believed linked to exposure to Agent Orange, which was dumped by the U.S. military in vast quantities over former South Vietnam to destroy crops and jungle cover shielding communist guerrilla fighters.Washington has been slow to address the issue, quibbling for years with its former foe over the need for more scientific research to show that the herbicide sprayed by U.S. aircraft during the war caused health problems and birth defects among Vietnamese."...... keywords:-
- FDA releases risk summaries for newer drugs - Reuters - An excerpt from the article states that "(Reuters) - U.S. health officials have started releasing summaries of safety reviews for recently approved medicines as part of their efforts to inform doctors and consumers about potential side effects.Politics | HealthThe information comes in part from post-approval reports of health problems from consumers, doctors and companies, Food and Drug Administration officials said as they unveiled the program on Tuesday. Agency reviewers also look at medical literature and ongoing studies.The FDA and companies track potential problems after a drug reaches the market as some side effects do not emerge in the smaller groups of people who take part in pre-approval testing.A 2007 law required the FDA to prepare a safety summary for certain prescription drugs 18 months after approval or after they have been used by 10,000 people, whichever comes later. Those summaries will now be posted on the FDA website.On Tuesday, the agency released summaries for 24 medicines and two vaccines for hypertension, allergies, HIV and other conditions. It included details on what action the agency was taking."...... keywords: -
- Heart stents used twice as often in U.S. vs. Canada - Reuters - An excerpt from the article states that "(Reuters Health) - U.S. heart patients are more likely to undergo stenting procedures to clear blocked coronary arteries than Canadians are, new research shows, but this doesn't necessarily mean they're getting better care.HealthSuch procedures, in which blocked heart arteries are cleared and then propped open with stents, are life-saving for heart attack patients. But a 2007 study showed that for patients with "stable" disease-meaning they aren't experiencing chest pain at rest-drugs are just as effective.The procedures are "highly profitable and generate considerable revenue for hospitals" under the US's current health care payment system, Dr. Edward L. Hannan of the State University of New York at Albany and his colleagues note in the new study, published in the journal Circulation."...... keywords: -
- GE recalls 181,000 washing machines - CNN - An excerpt from the article states that "NEW YORK (CNN) -- General Electric is recalling 181,000 front-load washing machines due to a faulty wire that poses a fire and shock risk, the company announced Thursday.The appliance maker said there have been seven incidents of minor smoke damage when flames escaped from the machines. No injuries have been reported.The company, conducting the recall in conjunction with the U.S. Consumer Product Safety Commission, is asking consumers to immediately stop using the hazardous machine, unplug it from the electrical outlet and contact GE (GE, Fortune 500) for a free repair.The recalled washers begin with model number WBVH5 and were sold nationwide from December 2006 through May 2010, retailing for about $700."...... keywords: recall -
- FDA Advisory Panel to Review Dental Amalgam - FDA - An excerpt from the article states that "The U.S. Food and Drug Administration today announced plans to hold an advisory panel on Dec. 14-15, 2010, to discuss several scientific issues that may affect the regulation of dental amalgam, used for direct filling of carious lesions or structural defects in teeth. The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.Used to treat tooth decay, dental amalgam is a mixture of metals, composed of liquid mercury and a powdered amalgam alloy, composed primarily of silver, tin, and copper.
On July 28, 2009, the FDA issued a final rule that reclassified dental mercury from a class I device to class II, classified dental amalgam as a class II device, and designated special controls for dental amalgam, mercury and amalgam alloy. The special control for the devices is a guidance titled, “Class II Special Controls Guidance Document: Dental Amalgam, Mercury and Amalgam Alloy.”Since that time, the agency has received several petitions raising various issues relating to the final rule and special controls.The concerns raised include the adequacy of the risk assessment method used by the FDA in classifying dental amalgam, the bioaccumulative effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam. In addition, a recent report on risk assessments issued by the National Academy of Sciences, titled “Science and Decisions: Advancing Risk Assessment, NAP 2009,” proposes new approaches to conducting risk assessments. These may be some of the issues the agency asks the advisory committee to review.Details about the advisory panel meeting will be published in the Federal Register on June 11, 2010 and is available for advanced viewing today only."...... keywords: -
- FDA warns Pfizer for not reporting side effects - Reuters - An excerpt from the article states that "(Reuters) - The U.S. Food and Drug Administration has warned Pfizer Inc for failing to quickly report serious and unexpected potential side effects from its drugs already on the market.U.S. | HealthIn a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples involving some of the company's top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica.The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDA's letter that was released by Pfizer on Wednesday.Ronald Pace, director of the FDA's New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use."...... keywords: -
- Valproic Acid Monotherapy in Pregnancy and Major Congenital Malformation - NEJM - An excerpt from the article states that "Background The use of valproic acid in the first trimester of pregnancy is associated with an increased risk of spina bifida, but data on the risks of other congenital malformations are limited. Methods We first combined data from eight published cohort studies (1565 pregnancies in which the women were exposed to valproic acid, among which 118 major malformations were observed) and identified 14 malformations that were significantly more common among the offspring of women who had received valproic acid during the first trimester."...... keywords:birth defects, birth injury -
- Major birth defects tied to common epilepsy drug - Reuters - An excerpt from the article states that "(Reuters Health) - The safety of a popular drug for seizures took another hit Wednesday when researchers pinned a handful of major birth defects on the medication.HealthEarlier research had shown that taking Depakote (valproate) during pregnancy might lower the baby's IQ and lead to deformities in up to one in ten cases. (See Reuters Health story April 16, 2009.)Scientists have long known about one of these malformations, called spina bifida, in which the fetus' spinal column doesn't close properly. But it was unclear whether the drug was linked to other birth defects, such as heart problems or extra short limbs.Writing in the New England Journal of Medicine, European researchers report an increased risk of six different birth defects in babies whose mothers took Depakote during their first trimester of pregnancy.The odds of spina bifida, for instance, were more than 12 times higher in these babies compared to those whose mothers didn't take epilepsy drugs. Abnormal skull development, cleft palate, holes in the heart's walls, extra fingers or toes, smaller limbs, and urinary problems were also more frequent in the Depakote group, with odds increased up to seven times.And five of these defects appeared to be specific to Depakote compared with other epilepsy drugs.Still, the researchers note, the actual frequency of specific birth defects were relatively small, all ranging below one percent. That compares to an overall rate of all birth defects of about 2 percent in the general population."...... keywords:birth defects, birth injury -
- BPA Exposure Much Higher in Canned Foods Than Plastic Containers - Fox - An excerpt from the article states that "Four years ago, just after giving birth to her second child, the stay-at-home mom heard about BPA, a chemical inside some plastics that can leach into water or food slowly over time, potentially causing serious health problems like cancer. Unwilling to take any risks, she ran to Babies "R" Us, which had a program to exchange baby bottles containing BPA, and walked out with $100 in rebates.If only life were so easy.What Sprague didn't realize is that BPA, or bisphenol A, is ubiquitous. Simply put, just about anything you eat that comes out of a can — from Campbell's Chicken Soup and SpaghettiOs to Diet Coke and BumbleBee Tuna — contains the same exact chemical.The exposure to BPA from canned food "is far more extensive" than from plastic bottles, said Shanna Swan, a professor and researcher at the University of Rochester in New York. "It's particularly concerning when it's lining infant formula cans."
BPA is the key compound in epoxy resin linings that keep food fresher longer and prevents it from interacting with metal and altering the taste. It has been linked in some studies of rats and mice to not only cancer but also obesity, diabetes and heart disease.Trade groups for chemical and can manufacturers say they stand behind the chemical, and point to some studies from governmental health agencies that deem BPA safe and effective for food contact. They also note that its use has substantially reduced deaths from food poisoning."...... keywords: -
- Rich prize awaits winner of race to treat obesity - The Times - An excerpt from the article states that "... In the Nineties, fen-phen diet pills made by Wyeth caused controversy and were withdrawn from the market after they were allegedly linked to heart valve damage. This year another treatment — Meridia, made by Abbott — was taken off the market in the European Union amid concerns that it could lead to an increased risk of heart attacks and strokes."...... keywords: fen phen, pph, heart valve, diet drug -
- Drop Dead Diva...: - EW.com - An excerpt from the article states that ".MC: I haven’t seen it, but I always think he’s funny. The fact about his humor is that in his comedy, people always say that he’s fat. So it’s interesting, he’s the one who’s been hurt by it, too, a lot. So I wonder what that means… In any case, as a comedian, I could never make fun of it because I almost killed myself so many times as a younger woman. I took so many diet pills. I have a heart murmur because I took Fen-Phen in the ’90s. I have permanent damage to my body because I wanted to be thin. That desire to have a smaller body, to take up less space in the world, was so important to me that I don’t remember most of my twenties. I didn’t appreciate the young woman that I was, or my young beauty, because I was so obsessed with the fact that I felt fat. It’s never good to add to anybody else’s suffering. It’s an important topic to really get the gravity and the importance of — dealing with dignity."...... keywords: fen phen, pph, heart valve, diet drug -
- EU drugs agency under fire again for data secrecy - Reuters - An excerpt from the article states that "LONDON, June 9 (Reuters) - The European Medicines Agency has been criticised for a second time by the European Ombudsman for not allowing outside investigators access to drug data. The latest case, centring on two obesity drugs from Roche (ROG.VX) and Sanofi-Aventis (SASY.PA), underscores the pressures on the EU regulator to increase transparency.Ombudsman Nikiforos Diamandouros said this week the decision by the agency not to give Danish researchers access to clinical study reports and trial protocols, as they had requested in 2007, was "an instance of maladministration".The team had asked for access to Phase III study results on rimonabant, the generic name for Sanofi's now-withdrawn Acomplia, as well as orlistat, which is sold by Roche as Xenical and in a low-dose form by GlaxoSmithKline (GSK.L) as Alli."...... keywords: accutane, IBD, colitis, crohn's disease, inflammatory bowel disease -
- Clarksburg woman sues C.R. Bard, others for defective medical device - (The Record) - An excerpt from the article states that "CHARLESTON -- A Clarksburg woman is suing Davol, C.R. Bard and Bard Devices after she claims she was implanted with a defective medical device.On Oct. 5, 2004, Janet S. Sayers underwent a ventral incisional hernia repair procedure at United Hospital Center in Harrison County, during which a Bard Composix Kugel Mesh Hernia Patch was implanted into her abdomen, according to a complaint filed May 12 in Kanawha Circuit Court.On Jan. 30, 2007, Sayers was admitted to United Hospital Center for diffuse abdominal pain, nausea and progressive weakness and was diagnosed with gastroenteritis, abdominal pain, hypokalemia, anemia, iron deficiency, hypertension and hypothyroidism, according to the suit.The Kugel Mesh Patch was recalled due to its undisclosed defects in June 2007, according to the suit, by Sayers was not made aware of this."...... keywords: bard, kugel mesh, hernia patch, recall -
- Study: Lax infection control at surgery centers - (AP: Daytona Beach-News Journal) - An excerpt from the article states that " CHICAGO (AP) -- A new federal study finds many same-day surgery centers - where patients get such things as foot operations and pain injections - have serious problems with infection control.Failure to wash hands, wear gloves and clean blood glucose meters were among the reported breaches. Clinics reused devices meant for one person or dipped into single-dose medicine vials for multiple patients.The findings, appearing in Wednesday's Journal of the American Medical Association, suggest lax infection practices may pervade the nation's more than 5,000 outpatient centers, experts said."These are basic fundamentals of infection control, things like cleaning your hands, cleaning surfaces in patient care areas," said lead author Dr. Melissa Schaefer of the Centers for Disease Control and Prevention. "It's all surprising and somewhat disappointing."The study was prompted by a hepatitis C outbreak in Las Vegas believed to be caused by unsafe injection practices at two now-closed clinics."...... keywords: negligence, medical malpractice -
- Do pregnancy and bipolar disorder mix? - CNN - An excerpt from the article states that " (Heath.com) -- As recently as 10 years ago, doctors advised women with bipolar disorder not to have children. While that thinking is now dated, bipolar women often face tough decisions about how to handle their medication during pregnancy.Most drugs prescribed for bipolar disorder carry some risk of birth defects, yet women who discontinue medication risk relapsing into a manic or depressive episode; during the postpartum phase the relapse rate is as high as 50 percent to 70 percent, by some estimates.Even more alarming, bipolar women are 100 times more likely than other women to experience postpartum psychosis, a severe mood disorder that, at its very worst, can result in infanticide.Health.com: Best bipolar blogsSally Martini, 38, started taking lithium after a severe manic episode eight years ago. She eventually switched to other drugs, but in 2007 she stopped her medication altogether when she learned that she was pregnant."...... keywords: birth defects, lung, heart -
- Subway Restaurant Salmonella Outbreak Strikes 60 People - Fox - An excerpt from the article states that " A salmonella outbreak linked to Subway restaurants in Chicago is expanding, myFOXchicago.com reported Tuesday citing state health workers.The number of Illinois cases linked to the Subway outbreak has gone up to 60."...... keywords: -
- GM Recalling 1.5 Million Vehicles for Fire Hazard - Fox - An excerpt from the article states that "General Motors Co. is recalling nearly 1.37 million vehicles because a washer fluid heater module could overheat and cause a fire, the National Highway Safety Administration said Tuesday.The recall covers the 2006-2009 Buick Lucerne, Cadillac DTS, Hummer H2; 2008-2009 Buick Enclave and Cadillac CTS; and 2007-2009 Cadillac Escalade, Escalade ESV, Escalade EXT, Chevrolet Avalanche, Silverado, Suburban, Tahoe, GMC Acadia, Sierra, Yukon, Yukon XL, Saturn Outlook and the 2009 model year Chevrolet Traverse."...... keywords: product liability-
- Lawmaker Questions Staffing Level Aboard Rig - WSJ - An excerpt from the article states that "The chairman of a congressional committee investigating the Gulf oil spill is questioning whether key personnel aboard the Deepwater Horizon oil rig were tired or off duty, in the hours before the explosion that destroyed the floating platform and started the Gulf of Mexico oil spill.Were there enough people on duty the day the Deepwater Horizon oil rig exploded? That's what Congress is asking. WSJ's Stephen Power joins the News Hub to discuss. Plus, Dow Jones Newswires' Neal Lipschutz talks about a repeated a pattern in this long but shallow recovery -- dashed investor hopes that economic growth will tack onto a higher trajectory.U.S. Rep. Nick Rahall (D., W.Va.) sent a letter Monday to rig owner Transocean Ltd. asking the company to explain company records submitted to his committee that he said suggest there was "a shortage of technical personnel" on duty at the time of the explosion, which killed 11 workers. Mr. Rahall is chairman of the House Natural Resources Committee, one of a half-dozen congressional panels probing the circumstances surrounding the disaster."...... keywords: -
- Bad medical writing hurts public health - CNN - An excerpt from the article states that "CNN) -- Each spring brings major medical meetings from the likes of the American Association for Cancer Research, the American Urological Association and the American Society for Clinical Oncology, to name a few.These meetings began as forums for scientists to meet and discuss findings and generate ideas. They offer opportunities for physicians to learn about new studies and possible new treatments, and for those interested in medicine, the meetings are fascinating and enjoyable.But over the past several decades, these gatherings have more and more become venues for drug companies and medical device manufacturers to tell physicians about their drugs and medical hardware. Today, much of the presented research is sponsored by industry, and these medical meetings are increasingly an opportunity for companies to make a name for themselves by promoting their products."...... keywords: -
- FDA needs vision, and a few more teeth: report - FDA - An excerpt from the article states that "(Reuters) - The U.S. Food and Drug Administration needs more clout, money and staff to help protect the U.S. food supply, but first of all it needs a coherent vision, a panel of experts said on Tuesday.Health
The Institute of Medicine report is the latest in a series of outside studies showing the FDA, which polices drugs and 80 percent of the U.S. food supply, does not have enough power.The report said FDA should be given authority to suspend food company registrations for violations that threaten the public health, and the authority to mandate recalls. The FDA usually now must coax companies into voluntarily recalling dangerous foods.Recent high-profile outbreaks, many involving produce such as lettuce, spinach, peppers and peanuts, have killed dozens of people and prompted an uproar from consumer groups.Congress has been working to overhaul the food safety system but legislation has been repeatedly bogged down by healthcare and regulatory reform. The House of Representatives passed food reform legislation in July. The Senate is expected to act this month."...... keywords: -
- Counterfeit Polypropylene Surgical Mesh: Initial Communication - FDA - An excerpt from the article states that "Audience: Surgical services managers, risk managers [UPDATED 06/08/2010] Recall classified as Class I.[Posted 03/12/2010] Counterfeit flat sheets of polypropylene surgical mesh, used in the repair of hernias and chest wall defects, are being marketed in the United States, labeled with the C. R. Bard/Davol brand name. These products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers’ polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. The product codes, sizes and lot numbers of the counterfeit product identified, to date, are noted in the linked Initial Communication, and recommendations/actions for healthcare professionals, healthcare facilities, and patients are provided.Healthcare professionals and patients are encouraged to report adverse events, product problems, or suspected counterfeit product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:"...... keywords: hernia patch -
- RECALL NOTICE - Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol - FDA -...... keywords: hernia patch -
- Actress Sues Bayer, Claims Birth Control Pill Caused Stroke at 27 - Fox - An excerpt from the article states that " A stunning stage actress is suing the drug giant Bayer, claiming its popular birth-control pill Yasmin caused her to have a stroke at age 27.Brenda Hamilton, who is an understudy in the Broadway show "Wicked," said she had been taking Yasmin for a little more than two years when she suffered the terrifying stroke in May 2007.
She has since recovered, but says in a civil suit filed in The Bronx that Bayer knew Yasmin posed a greater risk than did other birth-control pills for blood clots and strokes, but withheld that information from patients and doctors."I'm pretty angry that this happened to me. I was 27 at the time. I don't think this should be happening to young women. It shouldn't happen to any woman just because they take birth-control pills," she said.
Hamilton, a former Bronx resident who lives in West New York, NJ, had no history of health problems when she was stricken.Women have suffered strokes stemming from the use of other types of birth-control pills, which experts said were caused by increased levels of estrogen, and Bayer touts Yasmin particularly for its low estrogen levels. In 2008, the FDA cited Bayer for overstating the safety of the product in its advertising.
Hamilton's lawsuit is one of about 1,100 throughout the country claiming the pills caused serious or life-threatening health problems. Two class-action suits were also filed in Canada."...... keywords: yaz, yasmin, stroke, blood clot, pulmonary embolism -
- St. Jude Medical Settles Kickback Case - WSJ - An excerpt from the article states that "St. Jude Medical Inc. agreed to pay $3.7 million to the U.S. governmentto settle allegations the heart-device maker paid kickbacks to hospital customers in two states"...... keywords: -
- Recall raises questions about promotional glasses - The Herald News - An excerpt from the article states that " MILLVILLE, N.J. (AP) -- A recall of 12 million cadmium-tainted "Shrek" drinking glasses sold by McDonald's raises questions about the safety of millions of similar cheap promotional products that have been sitting in Americans' kitchen cabinets for years.
Only glasses produced for the latest "Shrek" movie are included in the voluntary recall announced Friday by the U.S. Consumer Product Safety Commission, but they were made by a company that McDonald's has worked with for 15 years. And many other companies make similar glassware with cartoon characters or other designs baked in."It could have been any glass company," said Ron Biagi, an executive with Arc International, which made the glasses. "We all do the same thing using materials from the same suppliers."McDonald's said the U.S.-made glasses met federal guidelines for cadmium under testing conducted by a CPSC-approved lab. CPSC spokesman Scott Wolfson, however, said the glasses fall short of standards for the toxic metal that the agency is in the process of developing.".... keywords: recall, toxic product -
- Meat, fish protein linked to women's bowel disease - Reuters - An excerpt from the article states that "(Reuters Health) - Eating lots of animal protein appears to increase women's risk of developing inflammatory bowel disease (IBD), according to a new study from France."Our results may help better understand the role of diet in IBD risk," Dr. Franck Carbonnel of the Center Hospitalier Universitaire de Bicetre in Paris and his team write in the American Journal of Gastroenterology. "If confirmed, they can lead to protective strategies, especially in families at risk of IBD, and possibly to advice for preventing relapse."Inflammatory bowel disease is a collective term for diseases characterized by severe inflammation in the digestive system such as ulcerative colitis, which typically only affects the colon, and Crohn's disease, which can attack the entire digestive tract. IBD, which affects about one in 500 people, has become much more common since World War II, Carbonnel and his colleagues note. The reasons behind the increase are still unclear.To investigate whether diet might be a factor, the researchers followed more than 67,000 women participating in a long-term study of risk factors for cancer and other common illnesses. The women were 40 to 65 years old when they enrolled in the study."... keywords: accutane, IBD -
- Patients Suing for 'Sex and Gambling Addictions' After Taking Parkinson's Drug - Fox - An excerpt from the article states that " A group of people suffering Parkinson’s disease are suing two Australian drug companies over medication which allegedly caused gambling and pornography addiction, the Sydney Morning Herald reported Friday.More than 100 people in the group have launched legal action against drug companies Pfizer Australia, over its drug Cabaser, and Aspen Pharmacare, over its drug Permax. The drugs are used to treat tremors associated with Parkinson's disease.".... keywords: -
- Scientists seek former students in toxic MT town - The Herald News - An excerpt from the article states that "Scientists seek former students in toxic MT town - SPOKANE, Wash. (AP) -- Researchers have embarked on an ambitious study to track the health of thousands of high school graduates over a half century in a Montana town where a toxic mine has killed hundreds of people and made it the deadliest Superfund site in the nation.People who attended Libby High between 1950 and 1999 and then moved away are being asked to submit to tests to help determine the extent of contamination caused by asbestos mining and processing in the northwestern Montana town. Researchers will track down many of the 13,000-plus graduates with the help of the school district and alumni groups, and then ask them to undergo a battery of X-rays, CT scans and pulmonary function tests.Dr. Stephen M. Levin of the Mount Sinai School of Medicine in New York said the study is part of a larger range of work trying to figure out why asbestos-related disease coming out of Libby appears to be particularly fast-moving and virulent."This progresses much more rapidly than your grandfather's asbestos-related disease," Levin said.
The mineral vermiculite was mined in Libby for much of the past century. At the mine's peak in the l970s, operator W.R. Grace produced almost 2 million tons of ore annually and employed about 200 miners and others. Vermiculite was shipped around the world to make insulation.".... keywords: asbestos, mesothelioma, cancer -
- A toxic history lesson - Reuters - An excerpt from the article states that "(CNN) -- Sometimes an old message can provide a fresh perspective.A 1940s marketing film for DDT helped do just that for CNN producers as we began investigating the potential risks of toxic chemicals. In the hourlong special report "Toxic Childhood," Dr. Sanjay Gupta examines the large number of chemicals our children are exposed to -- even before they're born -- and assessed what we know and don't know about their impact on our children's health.One of the many things we noticed in our investigation is that in the past, assurances that certain chemicals are completely safe have often turned out to be false.Special Report: Toxic AmericaFor example, lead. Lead was first put in gasoline in the 1920s because it was found to make engines run more smoothly. Lead took the pings out. And then we learned the price of a ping.In "Toxic Childhood," you'll meet Dr. Phil Landrigan, who discovered that contrary to what we thought decades ago, lead, even in small amounts, can damage the brains of children. And so, we no longer put lead in our gasoline.".... keywords: toxic exposure, toxic tort -
- Hormone patch may be safer for women - Reuters - An excerpt from the article states that "(Reuters) - Women who want to use hormone replacement therapy may be less likely to have a stroke if they use low-dose patches instead of pills, Canadian researchers reported on Thursday.HealthTheir study of British women showed that those who used estrogen patches to control symptoms of menopause did not have any higher risk of stroke than women who did not use HRT.The study, published in the British Medical Journal, adds to a very slowly growing body of evidence that could rehabilitate the use of HRT, which plummeted in 2002 after the publication of the Women's Health Initiative study, which found an increased risk of ovarian cancer, breast cancer, strokes and other health problems from hormone therapy.".... keywords: hormone patch, hormone replacement therapy, HRT -
- For Very Young, Peril Lurks in Lithium Cell Batteries - NY Times - An excerpt from the article states that "Last fall, 13-month-old Aidan Truett of Hamilton, Ohio, developed what seemed like an upper respiratory infection. He lost interest in food and vomited a few times, but doctors attributed it to a virus. After nine days of severe symptoms and more doctor visits, the hospital finally ordered an X-ray to look for pneumonia.What they found instead was totally unexpected. The child had ingested a “button” battery, one of those flat silver discs used to power remote controls, toys, musical greeting cards, bathroom scales and other home electronics.The battery was surgically removed the next day, and Aidan was sent home. But what neither the doctors nor his parents realized was that the damage had been done. The battery’s current had set off a chemical reaction in the child’s esophagus, burning through both the esophageal wall and attacking the aorta. Two days after the battery was removed, Aidan began coughing blood, and soon died from his injuries.".... keywords: -
- Medtronic Voluntarily Discloses Doctor Pay - WSJ - An excerpt from the article states that " Medical-device maker Medtronic Inc. disclosed that it made payments of more than $15.7 million in royalties and consulting fees to U.S. doctors in the first quarter, the first time the big Minneapolis company has provided such details. In making the voluntary disclosure, Medtronic is stepping ahead of requirements of a new federal law mandating such publication by 2013. ".... keywords: -
- Study confirms link between migraines and stroke - Reuters - An excerpt from the article states that "(Reuters Health) - People who suffer migraines are about twice as likely as people without the painful headaches to suffer a stroke caused by a blood clot, a new research review finds.The analysis, which combined the results of 21 previous studies, confirms a connection between migraines and ischemic stroke -- the most common form of stroke, occurring when a clot disrupts blood flow to the brain.Across the studies, migraine sufferers were about twice as likely to suffer an ischemic stroke as people without migraines, according to findings published in the American Journal of Medicine.Experts are not sure why the relationship exists, and it is not yet known whether the migraines themselves directly lead to strokes in some people.It's likely, however, that a common underlying process contributes to both migraines and stroke risk, said Dr. Saman Nazarian, the senior researcher on the new study and an assistant professor at Johns Hopkins University School of Medicine in Baltimore.For now, he told Reuters Health in an email, the bottom line for migraine sufferers is that they should be particularly vigilant about controlling any modifiable risk factors for stroke that they may have.".... keywords: -
- Justices Narrow Miranda Rule - WSJ - An excerpt from the article states that "Criminal defendants must specifically invoke the right to remain silent under the Miranda rule during questioning to avoid self-incrimination, the Supreme Court said Tuesday.The Supreme Court says if suspects want to stay silent, they first have to speak up. WSJ's Ashby Jones joins the News Hub with the latest.
The vote in the case was 5-4 along ideological lines as the court's conservatives put limits on the rights of suspects.Under the Miranda rule, derived from the 1966 Supreme Court decision in Miranda v. Arizona, police may not question a suspect who invokes his right to remain silent—and can't use as evidence incriminating statements obtained after the suspect does so.Review the cases already decided and still to come in the Supreme Court's 2009-2010 term, plus details on the arguments, the court's calendar, and the justices themselves.In Tuesday's decision, the court ruled that an ambiguous situation would be treated in favor of the police.The case came from Southfield, Mich., where a shooting suspect refused to sign a statement acknowledging that he had been given the Miranda warning, and didn't expressly state that he was invoking his right to remain silent.".... keywords: -
- Glaxo settles more Avandia lawsuits in U.S. - Yahoo (Reuters) - An excerpt from the article states that "LONDON (Reuters) – GlaxoSmithKline Plc has settled thousands more lawsuits brought by patients alleging its Avandia diabetes drug caused heart attacks, in a move that may defuse potentially massive claims over the medicine.A company spokeswoman said on Tuesday that consolidated cases which had been due to come to court in Philadelphia this month had been settled. She declined to give further details and said the terms remained confidential.The first product liability case involving Avandia will now go to court in the United States in October, she added.
The move follows the separate settlement of some 700 cases last month for about $60 million.Analysts estimate Glaxo had faced a total of 13,000 claims for damages involving Avandia, of which around 5,000 were consolidated in Philadelphia, and there had been fears it could face damages of up to $6 billion.However, last month's relative modest settlement deal and the latest settlement in Philadelphia suggests the amount paid out by the British-based drugmaker is likely to be a lot lower.".... keywords: avandia -
- Justices Narrow Miranda Rule - WSJ - An excerpt from the article states that "Criminal defendants must specifically invoke the right to remain silent under the Miranda rule during questioning to avoid self-incrimination, the Supreme Court said Tuesday.The Supreme Court says if suspects want to stay silent, they first have to speak up. WSJ's Ashby Jones joins the News Hub with the latest.
The vote in the case was 5-4 along ideological lines as the court's conservatives put limits on the rights of suspects.Under the Miranda rule, derived from the 1966 Supreme Court decision in Miranda v. Arizona, police may not question a suspect who invokes his right to remain silent—and can't use as evidence incriminating statements obtained after the suspect does so.Review the cases already decided and still to come in the Supreme Court's 2009-2010 term, plus details on the arguments, the court's calendar, and the justices themselves.In Tuesday's decision, the court ruled that an ambiguous situation would be treated in favor of the police.The case came from Southfield, Mich., where a shooting suspect refused to sign a statement acknowledging that he had been given the Miranda warning, and didn't expressly state that he was invoking his right to remain silent.".... keywords: -
- Behind the 'phantom recall' of Motrin - CNN - An excerpt from the article states that "NEW YORK (CNNMoney.com) -- A congressional committee is widening its investigation of a drug making arm of Johnson & Johnson to include an attempted 2009 "phantom" recall of Motrin.The House Committee on Oversight and Government Reform was already looking into several recalls by the division, McNeil PPC, and charges by the Food and Drug Administration of sloppy drug-making processes.Now it is looking into FDA charges that in June 2009, McNeil attempted to disguise its efforts to remove Motrin from store shelves without initiating a formal recall.After the FDA learned of the effort, it prompted McNeil to initiate a nationwide recall of more than 88,000 tablets of Motrin because of a problem with the way the drug dissolved, according to an FDA enforcement report.The FDA said it became aware of the alleged Motrin scheme after it obtained a memo that detailed instructions to contract workers to buy up Motrin from stores. The memo was first sent anonymously to Oregon state regulators."You should simply 'act' like a regular customer while making these purchases. There must be no mention of this being a recall of the product!" reads the memo dated June 12, 2009. ".... keywords: -
- Risk Management Program for Procrit, Epogen and Aranesp -FDA - An excerpt from the article states that "FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program. This program is designed to inform healthcare providers and their patients about the risks of these drugs and to ensure that they're administered appropriately when they're used to treat cancer patients for anemia.ESAs, sold as Procrit (epoetin alfa), Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), and stimulate the bone marrow to produce red blood cells. They're approved to treat anemia resulting from chemotherapy, chronic kidney failure and some HIV treatments, and also to reduce the number of blood transfusions during and after certain major surgeries.Studies have shown that ESAs can increase the risk of tumor growth and shorten survival in cancer patients. Also, any patient treated with these drugs may have a higher risk of heart attack, heart failure, stroke or blood clots.The risk management program requires health care professionals to provide patients receiving an ESA with a Medication Guide that contains information on how to safely use the drug. In addition, Amgen, the manufacturer of the three products, will oversee a training and certification program called APPRISE for health care professionals who administer chemotherapy to patients with cancer. Providers who treat these patients with ESAs must register and maintain active enrollment in the APPRISE program and complete a special training module on how to use ESAs in patients with cancer. They must also discuss the risks, benefits, and FDA-approved uses of ESAs with patients and document their discussion with a written acknowledgement from the patient. The APPRISE program does not apply to patients treated with an ESA for conditions other than cancer. Additional Information: * FDA MedWatch Safety Alert. Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication. February 16, 2010.
* ESA APPRISE Oncology Program".... keywords: -
- Hazards: Report on Sanitation at Swimming Pools - NY Times - An excerpt from the article states that "One in eight public swimming pools inspected in 2008 were closed immediately because of serious health code violations, according to a new report from the Centers for Disease Control and Prevention.Pools at child care facilities were the most likely to be shut down, with almost one in five closed immediately; the rate at hotels, motels and apartment complexes was one in seven.But it was kiddie wading pools and bathing fountains that had the highest rate of violations, indicating inappropriate disinfectant and pH levels in the water that could lead to transmission of germs that cause gastroenteritis.C.D.C. researchers analyzed data from more than 110,000 routine pool inspections drawn from a sample of 15 counties and states. Of 111,487 inspections, 13,532, or 12.1 percent, identified serious violations that led to immediate shutdowns. ".... keywords: -
- Environmental warrior takes on industry - CNN - An excerpt from the article states that "New Iberia, Louisiana (CNN) -- Chemist Wilma Subra was working at her desk by a picture window one cool June evening in 2006 when the passenger in a passing car fired a single shot in her direction. The bullet lodged in a brick a few feet from where she was sitting.Not your typical day at the office for a chemist, but Subra is not a typical chemist."I think they were just trying to scare me and get me to back off," says Subra, a soft-spoken grandmother who has made it her life's mission to help communities fight against chemical threats from industry.Subra didn't quit. She moved her desk away from the window and went back to work. The gunman was never caught."I can't close up and not be out there," she says matter-of-factly."Out there" means traveling to communities across the country worried about pollution.Mossville, Louisiana: 'Like an experiment' "Communities need so much help, and you educate and empower them, and then they take on the fight and the issue. They just need that little bit of information to make them aware."Subra received a MacArthur genius grant for her work in 1999. Her almost genteel manner belies the persistence and quiet intensity she brings to her work.".... keywords: -
- Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change - FDA - An excerpt from the article states that "Audience: Pain management healthcare professionals[Posted 05/25/2010] Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs and also warns of the risk of overdosage. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. Tramadol has mu-opioid agonist activity, can be abused and may be subject to criminal diversion.[April 2010 - Dear Healthcare Professional Letter1: Ultram - Ortho-McNeil-Janssen][April 2010 - Dear Healthcare Professional Letter2: Ultracet - Ortho-McNeil-Janssen]".... keywords: -
- Checklist cuts death rate for urgent surgery - Reuters - An excerpt from the article states that " NEW YORK (Reuters Health) - A simple checklist helps surgical teams avoid mistakes and cuts deaths by more than half during urgent surgery, a new study shows.The checklist tested in the new study was introduced in 2008 by the World Health Organization as part of its Safe Surgery Saves Lives program.It had already been shown to cut complications across all types of surgery, but there had been concern that when time is of the essence, running through a checklist might waste life-saving minutes.But that wasn't the case, said Dr. Atul A. Gawande, a surgeon at Brigham and Women's Hospital in Boston, Massachusetts, who worked on the study. Gawande has also written about checklists for The New Yorker magazine, where he is a staff writer, and in his 2009 book The Checklist Manifesto: How to Get Things Right."It has a kind of counterintuitive feel to it," he said. But in fact, "the teams did better when they took those two minutes to run through the checks."".... keywords: -
- Supreme Court to Weigh Seat-Belt Lawsuits Against Car Makers - WSJ - An excerpt from the article states that " WASHINGTON—The Supreme Court agreed Monday to decide whether federal regulations that set vehicle-safety standards should prohibit product liability lawsuits against car makers for installing lap-only seat belts.The court will consider a California lawsuit against Mazda Motor Corp. that stems from a 2004 fatal collision involving a 1993 Mazda MPV minivan. A rear-seat passenger wearing a lap-only seat belt was killed, and her family alleges that the lap-only belt was to blame. Two California courts ruled that the plaintiffs' lawsuit couldn't proceed because it was preempted by federal law.U.S. Solicitor General Elena Kagan had urged the Supreme Court to hear the case, arguing that the California courts and other courts have interpreted federal law too broadly to bar lawsuits against car makers that installed lap-only belts. She said the federal regulations were meant only as minimum standards. ".... keywords: -
- ADHD in kids tied to organophosphate pesticides - Reuters - An excerpt from the article states that " NEW YORK (Reuters Health) - Children exposed to pesticides known as organophosphates could have a higher risk of attention-deficit/hyperactivity disorder (ADHD), according to a new study.
Researchers tracked the pesticides' breakdown products in kids' urine and found those with high levels were almost twice as likely to develop ADHD as those with undetectable levels.The findings are based on data from the general US population, meaning that exposure to the pesticides could be harmful even at levels commonly found in children's environment."There is growing concern that these pesticides may be related to ADHD," said Marc Weisskopf of the Harvard School of Public Health, who worked on the study. "What this paper specifically highlights is that this may be true even at low concentrations."Organophosphates were originally developed for chemical warfare, and they are known to be toxic to the nervous system. There are about 40 organophosphate pesticides such as malathion registered in the US, the researchers wrote in the journal Pediatrics.Weisskopf said the compounds have been linked to behavioral symptoms common to ADHD -- for instance, impulsivity and attention problems -- but exactly how is not fully understood.".... keywords: -
- Women Win a Bias Suit Against Novartis - NY Times - An excerpt from the article states that " A British mother died after a doctor failed to spot a 6-inch long toilet brush handle embedded in her buttocks, a judicial investigation into her death was told Tuesday.Cindy Corton, 35, was left with the bizarre injury after a drunken fall in a friend's bathroom in 2005, but doctors missed it — even after taking X-rays.It was two years before Corton, who was in constant pain, was able to convince doctors that the thin serrated plastic handle was stuck in her flesh.By then, what should have been a routine procedure to remove it, had become much more dangerous because the handle was embedded in her pelvis.After two unsuccessful operations in 2007, the mother-of-one was in such agony that she agreed to undergo further surgery in June 2009, despite being told it could be fatal.".... keywords: -
- Women Win a Bias Suit Against Novartis - NY Times - An excerpt from the article states that "A federal jury in New York reached a verdict on Monday requiring Novartis Pharmaceuticals to pay $3.36 million to 12 former female sales representatives for discrimination in pay and promotions.Arguments will be made Tuesday for an award of punitive damages that could be even higher.Novartis — which for the last 10 years has been declared one of the Top 100 companies by Working Mother magazine — showed a pattern of discrimination against women employees from 2002 through 2007, the jury found after a five-week trial and four days of deliberation.
Novartis issued a statement saying it was disappointed in the verdict, believed the claims were unfounded and would appeal.“We are proud of the public honor and recognition we have received for the policies and programs we have in place to support the advancement of women in the sales force,” Brandi Robinson, a Novartis vice president, said in the statement.The jury, by checking the box for punitive damages on the verdict form, indicated it planned further punishment for Novartis. Each side will argue its case briefly Tuesday morning at the federal courthouse in Manhattan, and lawyers said the jury might set damages shortly after that.Twelve women who testified will share the compensatory damages for pain, suffering and loss of enjoyment in individual amounts ranging from $50,000 to nearly $600,000, set by the jury.More than 5,600 other Novartis female sales employees can apply in coming months for similar individual damages, to be set by a court-appointed special master, which could exceed $200 million, the class-action lawyers said. ".... keywords: -
- Whistle-Blowers' Experiences in Fraud Litigation against Pharmaceutical Companies - NEJM - An excerpt from the article states that "Prosecution and prevention of health care fraud and abuse are essential to reducing U.S. health care spending.1,2,3 A number of recent high-profile cases have uncovered suspect business practices and led to substantial recoveries; in September 2009, for example, Pfizer paid $2.3 billion to settle allegations that it marketed its drugs illegally to physicians, leading to unnecessary payments by the government.4".... keywords: whistleblower, qui tam, federal false claims act -
- Suspected E. Coli Outbreak at Gym Sickens 14 People - Fox - An excerpt from the article states that "JACKSON, Mo. — A southeast Missouri fitness center says it is taking appropriate steps to address a suspected outbreak of E. coli that state health officials say may have sickened 14 people. The Southeast Missourian of Cape Girardeau reports that the Missouri Department of Health and Senior Services says there have been five confirmed cases linked to Shawn McNally's Class Act Family Fitness business near Jackson.".... keywords: -
- Whistle-Blowers' Experiences in Fraud Litigation against Pharmaceutical Companies - NEJM - An excerpt from the article states that "Prosecution and prevention of health care fraud and abuse are essential to reducing U.S. health care spending.1,2,3 A number of recent high-profile cases have uncovered suspect business practices and led to substantial recoveries; in September 2009, for example, Pfizer paid $2.3 billion to settle allegations that it marketed its drugs illegally to physicians, leading to unnecessary payments by the government.4".... keywords: whistleblower, qui tam, federal false claims act -
- Evolving Data about Subtrochanteric Fractures and Bisphosphonates - NEJM - An excerpt from the article states that "Osteoporosis, a skeletal disorder characterized by reduced bone strength that predisposes to an increased risk of fracture, affects 10 to 12 million people in the United States. In 2000, there were 9 million fractures worldwide, of which 1.6 million were hip fractures. Fractures are important because of their association with an increased rate of death, substantial morbidity, enormous costs, and devastating effects on independence and quality of life.".... keywords: product liability -
- 2.5 Million Toy Buggies Recalled - Fox - An excerpt from the article states that "WASHINGTON — An Ohio company recalled 2.5 million ride-on toy buggies Wednesday, because a design flaw can allow them to roll away uncontrolled. The buggies, which resemble cars, have long handles so parents can push them like a stroller.The push handles on select Step2 Push Around and Whisper Ride buggies can detach, allowing the buggies to roll away without any means of control, according to the Consumer Product Safety Commission.".... keywords: product liability -
- Acute kidney failure - Mayo Clinic - An excerpt from the article states that "Acute kidney failure is the sudden loss of your kidneys' ability to perform their main function of eliminating excess fluid and salts (electrolytes) as well as waste material from your blood. When your kidneys lose their filtering ability, dangerous levels of fluid, electrolytes and wastes accumulate in your body.".... keywords: personal injury -
- Bisphosphonates and Fractures of the Subtrochanteric or Diaphyseal Femur - NEJM - An excerpt from the article states that "Background A number of recent case reports and series have identified a subgroup of atypical fractures of the femoral shaft associated with bisphosphonate use. A population-based study did not support this association. Such a relationship has not been examined in randomized trials. ..... Conclusions The occurrence of fracture of the subtrochanteric or diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years. There was no significant increase in risk associated with bisphosphonate use, but the study was underpowered for definitive conclusions. ".... keywords: bisphosphonates -
- Woman Paralyzed by E. Coli Infection Settles Lawsuit - Fox - An excerpt from the article states that "Stephanie Smith, 23, of Cold Spring, and Cargill said the terms of the settlement were confidential, but that it will provide for Smith's care throughout her life. The former children's dance instructor was left paralyzed, with cognitive problems and kidney damage. Smith became ill in 2007 after eating a patty produced by Cargill Meat Solutions Corp., a Wichita, Kans.-based unit of Minnetonka-based Cargill Inc. Her E. coli infection led to kidney failure. She went into seizures and was kept in a medically induced coma for three months. Smith's battle to recover was the centerpiece story last year in a New York Times series that won a Pulitzer Prize. The story spurred several members of Congress to demand better enforcement of food safety laws and a pledge from Agriculture Secretary Tom Vilsack for stepped up efforts to fight E. coli contamination. The story traced how the beef trimmings that went into her hamburger came from four plants in the U.S. and Uruguay, and that while such scraps are particularly vulnerable to contamination, many companies including Cargill did not normally test them prior to grinding.".... keywords: personal injury -
- Woman Paralyzed by E. Coli Infection Settles Lawsuit - Fox - An excerpt from the article states that "Stephanie Smith, 23, of Cold Spring, and Cargill said the terms of the settlement were confidential, but that it will provide for Smith's care throughout her life. The former children's dance instructor was left paralyzed, with cognitive problems and kidney damage. Smith became ill in 2007 after eating a patty produced by Cargill Meat Solutions Corp., a Wichita, Kans.-based unit of Minnetonka-based Cargill Inc. Her E. coli infection led to kidney failure. She went into seizures and was kept in a medically induced coma for three months. Smith's battle to recover was the centerpiece story last year in a New York Times series that won a Pulitzer Prize. The story spurred several members of Congress to demand better enforcement of food safety laws and a pledge from Agriculture Secretary Tom Vilsack for stepped up efforts to fight E. coli contamination. The story traced how the beef trimmings that went into her hamburger came from four plants in the U.S. and Uruguay, and that while such scraps are particularly vulnerable to contamination, many companies including Cargill did not normally test them prior to grinding.".... keywords: personal injury -
- ‘I Didn’t Want to Be Responsible for Somebody Dying’: Whistleblower - WSJ - An excerpt from the article states that "The impact of pharma-industry whistleblowers is hard to ignore, especially for the companies such as Eli Lilly, Merck and Bristol-Myers Squibb that paid out a total of more than $6 billion to settle whistleblower-initiated federal cases between Jan. 2001 and March 2009.
But in a special report, the New England Journal of Medicine takes a sort of “Behind the Music” approach to these whistleblowers, interviewing 26 of them individually to find out what motivated them to speak out and how the experience changed them. (Despite the $3 million median reward, “the prevailing sentiment was that the payoff had not been worth the personal cost.”) You can find the Dow Jones Newswires story about the report here.
As far as the initial discovery of wrongdoing goes, most whistleblowers reported that it happened after starting at a new company or being promoted to a new gig. Eleven reported initially refusing to participate in the actions they thought were wrong, and all but four said that before going to authorities they first took their complaints to higher-ups. (Five said they were then canned.)".... keywords: whistleblower, qui tam, federal false claims act -
- Jury Awards $29 Million in Nursing Home Death - Fox - An excerpt from the article states that "Sacramento, Calif. — Jurors have determined a Northern California-based nursing home chain should pay nearly $30 million in damages over the death of a 79-year-old former Stockton woman. The award comes after the Sacramento County Superior Court jury on Wednesday found Colonial Healthcare of Auburn and its parent company, Rocklin-based Horizon West Healthcare Inc., guilty of elder abuse in the 2005 death of Frances Tanner. After hearing testimony about the company's finances, jurors on Thursday determined the companies should pay $28 million in punitive damages to Tanner's estate and her daughter, Elizabeth Pao. The punitive damages are in addition to the $1.1 million in compensatory damages the jury awarded Wednesday."The jury made the award they did because they rejected the way Horizon West did business," said Ed Dudensing, the attorney representing Tanner's daughter and estate.Pao said Tanner was suffering from mild dementia, when she moved into the home in March 2005. After suffering a broken hip in a fall seven months later, Tanner died from an infected bedsore, Pao said.".... keywords: nursing home negelct, nursing home abuse, nursing home lawsuit -
- Perchlorate not tied to pregnancy thyroid problems - Reuters - An excerpt from the article states that "NEW YORK (Reuters Health) - Everyday exposure to perchlorate, an industrial chemical found in drinking water and a range of foods, may not impair thyroid function in pregnant women, a new study suggests. "Our data are reassuring," lead researcher Dr. Elizabeth N. Pearce, of Boston University School of Medicine, told Reuters Health in an email. "Although low-level perchlorate exposure was ubiquitous in the pregnant women we studied, perchlorate exposure was not associated with alterations in their thyroid function."Perchlorate is used to manufacture rocket propellant, fireworks, flares and explosives. It is also found as an impurity in some industrial and consumer products, like cleaners and bleaches. In the environment, perchlorate is found at low levels in drinking water and foods such as milk, wheat and a range of fruits and vegetables, and a 2002 U.S. government study found perchlorate in urine samples from all 2,820 adults included.In the body, sufficiently high levels of perchlorate slow down the transport of iodine to the thyroid gland, which churns out hormones that regulate metabolism and requires iodine. So there are concerns that perchlorate exposure could impair thyroid function -- an effect that would be particularly troubling during pregnancy, as adequate thyroid hormone is necessary for fetal brain development.".... keywords: perchlorate -
- Food Poisoning Suspected in 3 Louisiana Hospital Deaths - Fox - An excerpt from the article states that "PINEVILLE, La. — A health official says food poisoning perhaps from an ingredient in chicken salad could be what killed three Louisiana mental health hospital patients and sickened 40 others.
Officials say patients at Pineville's Central State Hospital showed signs of gastrointestinal stress beginning Friday morning. The three deaths — a 43-year-old woman, 41-year-old man and 52-year-old man — happened late Friday night or early Saturday morning.".... keywords: product -
- FDA approves new birth control pill Natazia - Reuters - An excerpt from the article states that "(Reuters) - The U.S. Food and Drug Administration said on Thursday it approved Bayer AG's new birth control pill Natazia. HEALTH The pill, already licensed in Europe under the brand name Qlaira, is the first four-phase oral contraceptive marketed in the United States, the FDA said. It delivers varying doses of the hormones progestin at four times throughout each 28-day treatment cycle. "Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives," said the FDA's Dr. Scott Monroe.".... keywords: product -
- 19,000 'Toxic' Charm Bracelets Made in China Recalled - Fox - An excerpt from the article states that "Federal regulators are expanding their investigation into children's jewelry that contains the toxic metal cadmium, promising that a recall announced Monday of "Best Friends" charm bracelets will not be the last. "More recalls are in the works," U.S. Consumer Product Safety Commission spokesman Scott Wolfson said. Those recalls would be the result of voluntary testing by companies, some of which have found troubling levels of cadmium and then reported those results to the agency, Wolfson said. He would not say how many products are under scrutiny. In addition, in recent weeks agency inspectors working at 10 of the nation's largest ports have screened imports of jewelry for cadmium. In one instance, a shipment of Chinese jewelry was turned away. Word of expanded federal efforts came as the consumer safety agency announced the voluntary recall of about 19,000 "Best Friends" charm bracelet sets made in China and sold exclusively at the jewelry and accessories store Claire's, which has more than 3,000 outlets in North America and Europe.".... keywords: product -
- Lettuce Recall Expands as FDA Investigates E. Coli - Fox - An excerpt from the article states that "A recall of romaine lettuce that has sickened students with E. coli poisoning is expanding as the government tries to find out where the contamination occurred. The Food and Drug Administration said late Monday that a food distributor in Moore, Okla., is recalling romaine lettuce that came from the same farm in Yuma, Ariz., that grew lettuce that sickened students in Michigan, Ohio and New York. Ohio-based Freshway Foods announced a 23-state recall of romaine lettuce last week related to those outbreaks.At least 19 people have been sickened in connection with the E. coli outbreaks, which come from a rare strain of the disease that is difficult to diagnose. Officials at the federal Centers for Disease Control and Prevention say they are looking at an additional 10 probable cases of E. coli poisoning from tainted lettuce. The FDA said it is investigating the Yuma farm where the romaine lettuce was harvested and is attempting to determine the point in the supply chain where the contamination occurred. The agency declined to identify the farm.".... keywords: product -
- Boston Scientific Bars Media From Meeting - Fox - An excerpt from the article states that "Boston Scientific Corp., coming off a $1 billion loss last year and a costly sales halt of key products because of internal paperwork problems, took the rare step Tuesday of barring reporters from its annual meeting.".... keywords: product -
- Lawyers: Rig workers asked to sign statements - SF Gate - An excerpt from the article states that "Workers aboard an exploding offshore drilling platform were told to sign statements denying they were hurt or witnessed the blast that rocked the rig, killed 11 and spewed millions of gallons of oil into the ocean, their attorneys said Tuesday. Survivors floated for hours in life boats in the Gulf of Mexico following the disaster on the Deepwater Horizon, and were greeted by company officials onshore asking them to sign statements that they had no "first hand or personal knowledge" of the incident, attorneys said.
Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2010/05/11/national/a104820D60.DTL&feed=rss.news#ixzz0neiZ5tUX".... keywords: product -
- Rig Owner Had Rising Tally of Accidents - WSJ - An excerpt from the article states that "The sinking of the Deepwater Horizon drilling rig, which triggered the spill spewing oil into the Gulf of Mexico, caught the energy world by surprise. The operator, Transocean Ltd., is a giant in the brave new world of drilling for oil in deep waters far offshore. It had been honored by regulators for its safety record. The very day of the blast on the rig, executives were aboard celebrating its seven straight years free of serious accidents. But a Wall Street Journal examination of Transocean's record paints a more equivocal picture. Nearly three of every four incidents that triggered federal investigations into safety and other problems on deepwater drilling rigs in the Gulf of Mexico since 2008 have been on rigs operated by Transocean, according to an analysis of federal data. Transocean defended its safety record but didn't dispute the Journal's analysis. In addition, an industry survey of oil companies that hired Transocean perceived a drop in its quality and performance, including safety by some measures, compared with its peers, though it still scored tops in one safety category.".... keywords: oil rig explosion -
- Sources: First 700 Avandia suits settled for $60M - Fierce Pharma - An excerpt from the article states that "If the first round of Avandia settlements sets the trend, GlaxoSmithKline (NYSE: GSK) could suffer a lot less from the thousands of lawsuits filed over the diabetes drug. Sources tell Bloomberg the company has agreed to pay $60 million to resolve more than 700 Avandia suits, which amounts to about $86,000 per case. That's way below the $500,000 per case that some analysts had forecast. Back in 2007, a New England Journal of Medicine study linked taking Avandia to an increased risk of heart attack, touching off a debate over the drug's safety that continues to this day. FDA warnings have been applied; new data has surfaced; Avandia sales have dropped. And along the way, Avandia users have sued the company, claiming that the drug caused their heart attacks and strokes. As Reuters notes, Morgan Stanley recently said that GSK's stock is discounting a $6 billion liability risk from those lawsuits.".... keywords: avandia -
- US cancer costs double in nearly 20 years - Sun Journal - An excerpt from the article states that "ATLANTA (AP) -- The cost of treating cancer in the United States nearly doubled over the past two decades, but expensive cancer drugs may not be the main reason why, according to a surprising new study.
The study confounds conventional wisdom in several respects. The soaring price of new cancer treatments has received widespread attention, but the researchers conclude that rising costs were mainly driven by the growing number of cancer patients. The study also finds cancer accounts for only 5 percent of total U.S. medical costs, and that has not changed in the last few decades. "I will say I'm a bit surprised," said Dr. Len Lichtenfeld of the American Cancer Society, who said he would have expected the proportion of cancer costs to rise. The researchers also found that private insurers now cover a greater share of cancer treatment costs - about 50 percent - while patients' out-of-pocket costs have fallen over the past two decades.Though taken aback by some of the findings, Lichtenfeld and other experts did not dispute the study, which compared medical cost data from the late 1980s to that of the early 2000s. But they said the picture surely has changed in the last several years. The study is being called the first to combine national cancer costs for all types of payers and see how they've changed over time. The figures are reported in 2007 dollars.It found that cancer treatment costs rose from nearly $25 billion in 1987 to more than $48 billion by the end of 2005..".... keywords: cancer -
- Parents Claim 'Pampers' Diapers Caused Chemical Burns - Fox- An excerpt from the article states that "The U.S. Consumer Product Safety Commission has launched an investigation into Pampers diapers with Dry Max after some parents complained that the new Procter & Gamble Co diapers appear to be the cause of rashes and chemical burns on their children. Pampers recently updated its Swaddlers and Cruisers diapers with a thinner, more absorbent technology in what the company has called its biggest diaper innovation in 25 years.Several parents have said that their children developed diaper rashes and some claim to have seen chemical burns on their children after they started using the products, which P&G said went through extensive testing.The staff of the CPSC is looking into complaints being made by parents and is in discussions with P&G about the product, said Scott Wolfson, the agency's director of public affairs.P&G said it has shared its safety data with the agency and stands by its product. "There's no evidence that a single baby has experienced a serious skin safety issue as a result of Dry Max," said Bryan McCleary, a spokesman for P&G's baby care division.Every day, about 2.5 million babies in the United States have diaper rash. About 10 percent of those cases are severe, with deep red coloring, blisters and/or breaks in the skin, he said..".... keywords: product -
- Bayer wins U.S. approval for new birth control pill -Reuters - An excerpt from the article states that "The U.S. Food and Drug Administration said on Thursday it approved Bayer AG's new birth control pill Natazia.The pill, already licensed in Europe under the brand name Qlaira, is the first four-phase oral contraceptive marketed in the United States, the FDA said.It delivers varying doses of the hormones progestin at four times throughout each 28-day treatment cycle.
"Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives," said the FDA's Dr. Scott Monroe."The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception."".... keywords: yaz, yasmin product -
- Bypass, stents equally safe five years on: study - Reuters- An excerpt from the article states that "(Reuters) - Patients who got heart bypass surgery and those who got their blocked arteries propped open with stents fared equally well five years after their procedures, South Korean doctors reported on Wednesday.The study of more than 2,200 patients showed no difference in death, heart attack or stroke between the two groups, Dr. Duk-Woo Park of Ulsan College of Medicine in Seoul and colleagues reported.The patients all had a serious heart blockage called unprotected left main coronary artery stenosis, which doctors agree needs treatment.But heart surgeons have disagreed about whether stretching the artery open and inserting a wire mesh tube called a stent is as effective as more traditional bypass surgery.".... keywords: stent, heart stent, drug eluting stent, medicated stent -
- Conair recalls 291,000 hair dryers - CNN - An excerpt from the article states that "NEW YORK (CNNMoney.com) -- Conair Corp. is recalling 291,000 BabylissPro model hair dryers because they pose a laceration risk, a government agency said Friday. Conair (CNGA) disclosed 16 reports of the fan breaking, causing the plastic shell to shatter, as well as reports of hair dryers sparking and smoking, the U.S. Consumer Product Safety Commission (CPSC) said in a statement. So far, seven people have reported minor cuts and one customer reported seeking medical attention for a cut on the hand, according to the CPSC. The East Windsor, N.J.-based company manufactures hair dryers, curling irons, straighteners, and other personal grooming and home care appliances. A Conair spokesman, who asked not to be named, said that the recall was a "precautionary" measure, done in an "ambundance of caution." He declined to comment further.".... keywords: product -
- Americans "bombarded" with cancer causes: report - Reuters - An excerpt from the article states that "(Reuters) - Americans are being "bombarded" with chemicals, gases and radiation that can cause cancer, and the federal government must do far more to protect them, presidential cancer advisers said on Thursday.
HEALTH Although most experts agree that as many as two-thirds of cancer cases are caused by lifestyle choices like smoking, poor diet and lack of exercise, the two-member panel said many avoidable cancers were also caused by pollution, radon gas from the soil and medical imaging scans. Some of the advisers' points are not in dispute. Several government-sponsored reports have pointed to cancer risks from X-rays and CT scans, and industry and physician groups are already working on ways to lower the doses given to people. Radon has been a known source for decades, and the Food and Drug Administration and National Institutes of Health are studying the possible effects of the common plastics ingredient bisphenal A or BPA. But other points have little science to back them. For instance, the panel said that since so little is known about the potential risks of cell phones, people would be prudent to wear headsets and make calls quickly. Many large studies have found no links between cell phone use and cancer. "The panel was particularly concerned to find that the true burden of environmentally induced cancer has been grossly underestimated," reads the report, available at www.pcp.cancer.gov. The report is sure to stun industry and many cancer specialists. It has already delighted environmental groups, which have had hints for more than a week of the report's content and scheduled news conferences for later on Thursday. The American Cancer Society said the report downplayed known risks that cause most cases of cancer including tobacco, obesity, alcohol, infections, hormones and sunlight.".... keywords: cancer-
- New U.S. Push to Regulate Internet Access - WSJ - An excerpt from the article states that "WASHINGTON—In a move that will stoke a battle over the future of the Internet, the federal government plans to propose regulating broadband lines under decades-old rules designed for traditional phone networks. The decision, by Federal Communications Commission Chairman Julius Genachowski, is likely to trigger a vigorous lobbying battle, arraying big phone and cable companies and their allies on Capitol Hill against Silicon Valley giants and consumer advocates. Breaking a deadlock within his agency, Mr. Genachowski is expected Thursday to outline his plan for regulating broadband lines. He wants to adopt "net neutrality" rules that require Internet providers like Comcast Corp. and AT&T Inc. to treat all traffic equally, and not to slow or block access to websites.".... keywords: product -
- Washington Supreme Court Rules on Internet Filters - WSJ - An excerpt from the article states that "OLYMPIA, Wash.—Public libraries' use of Internet filters to block content doesn't run afoul of the state constitution, the Washington state Supreme Court ruled Thursday. In a 6-3 ruling, the majority said libraries have discretion about which Internet content to allow, just as they decide which magazines and books to offer."A public library can decide that it will not include pornography and other adult materials in its collection in accord with its mission and policies and, as explained, no unconstitutionality necessarily results," wrote the majority, led by Chief Justice Barbara Madsen. "It can make the same choices about Internet access."Justices Susan Owens, Charles Johnson, Mary Fairhurst and Gerry Alexander signed on in agreement.Justice Jim Johnson wrote a separate opinion, agreeing with the majority conclusion but saying the focus of the reasoning should be on scarcity of resources that libraries deal with, which in turn allows them to filter materials they obtain for their collections.The majority said libraries, while not completely removing Internet filters, can provide access to individual websites containing constitutionally protected speech if requested by an adult.A blistering dissent by Justice Tom Chambers argued the ruling restricts constitutionally protected speech.Justice Chambers, joined by Justices Richard Sanders and Debra Stephens, said censoring material on the Internet is not the same as declining to purchase a particular book."It is more like refusing to circulate a book that is in the collection based on its content," he wrote.".... keywords: internet -
- U.S. lawmakers seek data from FDA on J&J recall - WSJ - An excerpt from the article states that "(Reuters) - U.S. lawmakers on Thursday requested information from regulators about Johnson & Johnson's recall of Children's Tylenol and other over-the-counter pediatric medicines, saying the company's repeated recalls "point to a major problem" with production.The U.S. House of Representatives Committee on Oversight and Government Reform has opened an investigation after J&J recalled 40 widely used children's pain and allergy medications, saying some may have a higher concentration of their active ingredients, while others may be contaminated. In a damning FDA report issued on Tuesday, inspectors said they found thick dust, grime and contaminated ingredients at the J&J plant that produces Children's Tylenol and dozens of other products recalled last week. J&J has now had four recalls in the past year of over-the-counter medicines."Taken together, these recalls point to a major problem in the production of McNeil products," Committee Chairman Edolphus Towns, a New York Democrat, and the panel's ranking Republican, Darrell Issa of California, said in a release, referring to J&J's consumer healthcare unit."Given McNeil's questionable track record and consecutive recalls, we need to understand what prior actions the (Food and Drug Administration) took to address McNeil's quality control problems and what events led the FDA to its April 2010 inspection of McNeil's Fort Washington plant."The committee requested information and records in a letter to FDA Commissioner Margaret Hamburg, which was included in its press release on Thursday.".... keywords: product -
- Baxter to recall infusion pumps - Reuters - An excerpt from the article states that "(Reuters) - Baxter International Inc said on Monday it will recall its Colleague infusion pumps from the U.S. market on an order from the Food and Drug Administration under the company's June 2006 consent decree with the agency.
Health Baxter said it will record a special pre-tax charge of $400 million to $600 million in the first quarter for the estimated cost of the recall. The Deerfield, Illinois-based company said it would not otherwise revise its earnings outlook for the year. The recall affects around 200,000 pumps, according to Baxter spokeswoman Erin Gardiner. The FDA said it sent a letter to Baxter on April 30 ordering the company to recall and destroy all of its Colleague pumps in use in the United States and to provide refunds to customers or replace pumps at no cost. "This action is based on a long-standing failure to correct many serious problems with the pumps," the FDA said in a statement..".... keywords: product -
- Wal-Mart to pay $27.6M in California dumping case - AP - An excerpt from the article states that " SAN DIEGO (AP) -- Wal-Mart Stores Inc. has agreed to pay $27.6 million to settle allegations that it improperly handled and dumped hazardous waste at stores across California in a case that led to changes in the retailer's practices nationwide, prosecutors said Monday. The settlement ends a five-year investigation involving more than 20 prosecutors and 32 environmental groups. They alleged that each of the company's 236 stores and distribution centers across California, including Sam's Club warehouse stores, were in violation of environmental laws and regulations, said San Diego County District Attorney Bonnie Dumanis. Wal-Mart was accused of improperly disposing of pesticide, fertilizer, paint, aerosols and other chemicals. In one case, Dumanis said a Solano County boy was found playing in a mound of fertilizer near a Walmart garden section. The yellow-tinted powder contained ammonium sulfate, a chemical compound that causes irritation to people's skin, eyes and respiratory tract. "Today a corporate giant has been held accountable for its actions, and Wal-Mart is cleaning up its act," Dumanis said. Wal-Mart still may shell out more money because of civil and criminal investigations by federal officials into allegations that the company's handling of hazardous waste violated environmental laws in California, Missouri and Washington, D.C. The federal cases are still pending, including in California.
California's state investigation started in 2005 when an employee from the San Diego County Department of Environmental Health saw a worker pouring bleach down a drain, prosecutors said. Phyllis Harris, who handles Wal-Mart's environmental affairs, said the company has improved since the violations were discovered.".... keywords: environmental-
- Whistleblower Twice Over: First Lilly, Now AstraZeneca - WSJ - An excerpt from the article states that "It might be tough for James Wetta to get his next pharma job – then again, now that he’s a millionaire, he probably doesn’t need it. The former AstraZeneca sales rep filed a whistleblower lawsuit against the company in 2004 that was only yesterday made public. Astra is going to pay $520 million to settle a probe into its marketing of the antipsychotic Seroquel (it denies the charges), and Wetta stands to pocket some portion of $45 million for his role in the investigation. He’s sharing the money with another whistleblower. But the California resident has been down this road before, Dow Jones Newswires reports. He also helped the government in a similar probe of Eli Lilly, his previous employer. Lilly last year paid upwards of $1.4 billion to settle its own antipsychotic marketing issues with the Justice Department. (It, too denied the charges.) Wetta got a piece of the $100 million of that settlement reserved for whistleblowers..".... keywords: whistleblower, qui tam, federal false claims act-
- Toys banned in some California fast food restaurants - CNN - An excerpt from the article states that "(CNN) -- A California county on Tuesday became the first in the nation to ban toys from fast food kids' meals high in calories, fat, salt and sugar. Santa Clara County supervisors voted 3-2 to ban the plastic goodies as promotions in meals with more than 485 calories. County supervisor Ken Yeager said Tuesday that the ordinance "prevents restaurants from preying on children's love of toys to peddle high-calorie, high-fat, high-sodium kids' meals," and would help fight childhood obesity. "This ordinance breaks the link between unhealthy food and prizes," Yeager said. "Under this ordinance, restaurants are still permitted to give out toys. This ordinance merely imposes very specific, common-sense nutrition standards for children's meals that are linked to these incentives." The ordinance will ban restaurants from giving away toys with meals that have more than 485 calories, more than 600 milligrams of sodium, more than 35 percent of total calories from fat or more than 10 percent of calories from added sugar. It would also limit toy giveaways on single food items with more than 200 calories or more than 480 milligrams of sodium.
But the decision, which affects about a dozen fast food restaurants in unincorporated areas of Silicon Valley, has angered the California Restaurant Association, which fought the proposal with ads in local newspapers. One asks "Who Made Politicians the Toy Police?" and shows a child in handcuffs in front of a cop.".... keywords: -
- Critics cite Avandia in pushing FDA safety reforms - Reuters - An excerpt from the article states that "(Reuters) - The controversy surrounding a GlaxoSmithKline Plc diabetes drug points to a need for changes in the way the U.S. Food and Drug Administration handles safety issues, agency critics told lawmakers on Wednesday. HEALTH The FDA is taking a new look at the safety of Glaxo's Avandia pill, which carries a warning about heart risks. The manufacturer says the drug is safe and effective, and the FDA is advising patients to keep taking the drug as directed. Two drug safety reviewers have recommended that the drug come off the market after concluding it was more dangerous to the heart than rival drug Actos by Takeda Pharmaceutical Co Ltd. That has prompted new calls for more independence and power for the reviewers who analyze a drug's risks after it reaches the market, an idea circulating for years. Critics say more authority lies with the staff who approve drugs and are therefore reluctant to withdraw a medicine they supported. "Individuals in the office responsible for post-market surveillance should be allowed to provide an independent opinion based on the best available evidence," Republican Senator Charles Grassley told a House of Representatives Appropriations subcommittee. The FDA has said it is undertaking an internal review of drug safety decision-making in addition to bringing Avandia to an advisory panel of outside experts in July. "This review will make recommendations regarding the agency's approach to safety issues including Avandia," FDA spokeswoman Karen Riley said on Wednesday. A panel that met in 2007 heard from a safety reviewer who felt the drug should no longer be sold. That panel voted 22-1 that Avandia was safe enough to stay on the market. Representative Rosa DeLauro, the subcommittee's chairwoman, said the "evidence suggests that we should look into strengthening either the independence or the powers of the FDA's drug safety office so that its recommendations no longer go unheeded." DeLauro said she wanted to provide input to the FDA ahead of the July advisory panel meeting. She also said she might pursue FDA safety reforms when her panel is setting funding levels for the agency. "We would like to address some of these issues," she said. Another witness at Wednesday's hearing, Dr. Harlan Krumholz, said drugmakers should disclose more clinical trial data so independent researchers can evaluate it. Companies must release summaries of study results but should also provide raw data with more details, Krumholz said. "I still don't think we know the full story (on Avandia). We have not seen the raw data," said Krumholz, a Yale University cardiologist..".... keywords: avandia, diabetes, heart attack-
- Kidney stones on the rise in South Carolina children - Reuters - An excerpt from the article states that "NEW YORK (Reuters Health) - Kidney stones can be excruciating no matter what your age and while they are rare in children, a new study shows they more than doubled among South Carolina kids between 1996 and 2007. HEALTH "The trend is concerning," Dr. David J. Sas, a pediatric kidney specialist at the Medical University of South Carolina, told Reuters Health. Sas and colleagues combed state hospital emergency department data for the diagnosis of kidney stones in children from birth to age 18.
They found that the number of cases per 100,000 children climbed from 7.9 to 18.5 over the 12 years of the study. In all, 1,535 children were diagnosed with the painful disease. The greatest increase occurred among white adolescents between the ages of 14 and 18, according to a report in the Journal of Pediatrics. Running contrary to the gender breakdown of kidney stone formation in adults, the increase in stone formation among South Carolina girls was particularly intriguing to the researchers. "In the 90s, the rate of stone formation was the same between boys and girls. However, over the last decade and a half, the girls have outpaced the boys and are now about 50 percent more likely to form stones than boys," Sas said.".... keywords: -
- LaHood: Texting While Driving an Epidemic- Fox - An excerpt from the article states that "Transportation Secretary Ray LaHood calls texting while driving “an epidemic” that he is committed to helping stop. The secretary appeared at the Newseum in Washington Friday to take part in a special broadcast of the “The Oprah Winfrey Show” devoted to raising awareness of the issue. “I think if we really persuade people to take their cell phones out of their hands while they're driving we'll save a lot of lives,” LaHood said. “I’ve heard the heartbreaking stories from families all over America who've lost loved ones because somebody thought they could drive safely and talk, or text and talk. You just simply can't do it.” Winfrey launched her “No Phone Zone” public awareness campaign in January, asking viewers and members of the public to sign a pledge agreeing not to use their phones at all while driving, to stop texting and use only hands-free calling, or to not text while driving. To date more than 234,000 people have taken the pledge, including high profile celebrities like Jerry Seinfeld, Tina Fey, NASCAR Driver Jimmy Johnson, Randy Jackson and Morgan Freeman..".... keywords: texting-
- BP plan deemed major spill from Gulf well unlikely - Winstom-Salem Journal - An excerpt from the article states that "VENICE, La. (AP) -- The worst U.S. oil spill in decades reached into precious shoreline habitat along the Gulf Coast as documents emerged showing British Petroleum downplayed the possibility of a catastrophic accident at the offshore rig that exploded. The underwater spill remained unstopped and impossible to measure, raising fears that it could be pouring more oil into the Gulf than estimated. President Barack Obama was planning to head to the Gulf Coast sometime in the next 48 hours to get an update on efforts to contain the massive spill, a senior administration official said Saturday on condition of anonymity because the trip has not been officially announced. Details of the trip were still being worked out. BP suggested in a 2009 exploration plan and environmental impact analysis for the well that an accident leading to a giant crude oil spill - and serious damage to beaches, fish and mammals - was unlikely, or virtually impossible. The Coast Guard estimates now that at least 1.6 million gallons of oil have spilled since the April 20 explosion that killed 11 workers. The environmental catastrophe could eclipse the Exxon Valdez disaster, when an oil tanker spilled 11 million gallons off Alaska's shores in 1989. "The sort of occurrence that we've seen on the Deepwater Horizon is clearly unprecedented," BP spokesman David Nicholas told The Associated Press on Friday. The plan for the Deepwater Horizon well, filed with the federal Minerals Management Service, said repeatedly that it was "unlikely that an accidental surface or subsurface oil spill would occur from the proposed activities." The company conceded a spill would impact beaches, wildlife refuges and wilderness areas, but argued that "due to the distance to shore (48 miles) and the response capabilities that would be implemented, no significant adverse impacts are expected." Robert Wiygul, an Ocean Springs, Miss.-based environmental lawyer and board member for the Gulf Restoration Network, said he doesn't see anything in the document suggesting BP addressed the kind of technology needed to control such an enormous spill that far underwater. "The point is, if you're going to be drilling in 5,000 feet of water for oil, you should have the ability to control what you're doing," he said.".... keywords: oil spill-
- Ron Fimrite, master storyteller, dies at 79 - San Francisco Chronicle - An excerpt from the article states that "(04-30) 19:44 PDT SAN FRANCISCO -- Ron Fimrite, whose polished prose and piercing wit delighted readers of The Chronicle and Sports Illustrated for many years, died Friday of pancreatic cancer. He was 79. The author of numerous books, including histories of the World Series, Cal football, the Washington Square Bar & Grill and the Olympic Club, died in his San Francisco home. Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/05/01/MN7I1D597I.DTL&feed=rss.news#ixzz0mmPsstsF.".... keywords: pancreatic cancer-
- Plavix gets new FDA warning -Reuters - An excerpt from the article states that "(Reuters) - The blockbuster anti-clotting drug Plavix will carry a new warning about patients who have a poor response to the drug because they do not break it down well, U.S. regulators said on Friday. HEALTH The Food and Drug Administration said it was adding a new boxed warning to Plavix, an $8-billion-a-year drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis SA.
The new language will "warn about reduced effectiveness in patients who are poor metabolizers of Plavix," the FDA said in a notice on its website. Poor metabolizers are people whose bodies do not effectively convert Plavix to its active form."Because the patient makes less of the active form there is less anti-platelet effect in the blood and the patient may not receive the full benefit of Plavix treatment," Mary Ross Southworth of the FDA's Center for Drug Evaluation and Research told reporters in a teleconference. An estimated 2 percent to 14 percent of the population are poor metabolizers of Plavix, the FDA said.Bristol said published studies suggested the percentage of poor metabolizers is approximately 3 percent. "Patients should continue taking Plavix unless told to do otherwise by their healthcare professional," the company said in a statement. The new warning will advise doctors of genetic tests that can identify those patients and to consider alternatives for them.".... keywords: plavix, drug stent, stent, drug eluting stent, heart-
- FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug - FDA - An excerpt from the article states that "Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
Safety Announcement
[03-12-2010] The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the label for Plavix, the anti-blood clotting medication. The Boxed Warning is about patients who do not effectively metabolize the drug (i.e. "poor metabolizers") and therefore may not receive the full benefits of the drug.
The Boxed Warning in the drug label will include information to:
• Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.
• Inform healthcare professionals that tests are available to identify genetic differences in CYP2C19 function.
• Advise healthcare professionals to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.
Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease. Plavix works by decreasing the activity of blood cells called platelets, making platelets less likely to form blood clots.
For Plavix to work, enzymes in the liver (particularly CYP2C19) must convert (metabolize) the drug to its active form. Patients who are poor metabolizers of the drug, do not effectively convert Plavix to its active form. In these patients, Plavix has less effect on platelets, and therefore less ability to prevent heart attack, stroke, and cardiovascular death. It is estimated that 2 to 14% of the population are poor metabolizers; the rate varies based on racial background.
Healthcare professionals should be aware that a subgroup of patients are poor metabolizers and do not metabolize Plavix effectively; this can result in reduced effectiveness of Plavix. Healthcare professionals should consider use of other anti-platelet medications or alternative dosing strategies for Plavix in these patients.
Patients should not stop taking Plavix unless told to do so by their healthcare professional. They should talk with their healthcare professional if they have any concerns about Plavix, or to find out if they should be tested for being a poor metabolizer.
In May 2009, FDA added information about poor metabolizers of Plavix to the drug label. However, based on additional data reviewed by the agency (see Data Summary below) the Boxed Warning is now being added to highlight the reduced effectiveness of Plavix in these patients and to recommend that healthcare professionals consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.
Additional Information for Patients
Patients currently taking Plavix should:
• Be aware that some patients do not convert Plavix to its active form as well as other patients. These patients may not get the same benefit from Plavix and are known as poor metabolizers.
• Not stop taking Plavix unless told to do so by their healthcare professional.
• Talk with their healthcare professional if they have any concerns about Plavix.
• Talk with their healthcare professional to see if testing to determine their metabolizer status is appropriate.
Additional Information for Healthcare Professionals
FDA recommends that healthcare professionals should:
• Be aware that some patients may be poor metabolizers of Plavix. They do not effectively convert Plavix to its active form because of low CYP 2C19 activity.The effectiveness of Plavix as a preventive therapy is reduced in these patients.
• Be aware that tests are available to determine patients' CYP2C19 status.
• Consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients who have been identified as poor metabolizers.
• Be aware that although a higher dose regimen (600 mg loading dose followed by 150 mg once daily) in poor metabolizers increases antiplatelet response, an appropriate dose regimen for poor metabolizers has not been established in a clinical outcome trial.
• Review the newly approved Plavix drug label for complete information on the use of Plavix
Data Summary
The liver enzyme CYP2C19 is primarily responsible for the formation of the active metabolite of Plavix. Pharmacokinetic and antiplatelet tests of the active metabolite of Plavix show that the drug levels and antiplatelet effects differ depending on the genotype of the CYP2C19 enzyme. The following represent the different alleles of CYP2C19 that make up a patient's genotype:
• The CYP2C19*1 allele has fully functional metabolism of Plavix.
• The CYP2C19*2 and *3 alleles have no functional metabolism of Plavix. These two alleles account for most of the reduced function alleles in patients of Caucasian (85%) and Asian (99%) descent classified as poor metabolizers.
• The CYP2C19*4, *5, *6, *7, and *8 and other alleles may be associated with absent or reduced metabolism of Plavix, but are less frequent than the CYP2C19*2 and *3 alleles.
• A patient with two loss-of-function alleles (as defined above) will have poor metabolizer status.
The pharmacokinetic and antiplatelet responses to Plavix were evaluated in a crossover trial in 40 healthy subjects. Ten subjects in each of the four CYP2C19 metabolizer groups (ultrarapid, extensive, intermediate and poor) were randomized to two treatment regimens: a 300 mg loading dose followed by 75 mg per day, or a 600 mg loading dose followed by 150 mg per day, each for a total of 5 days. After a washout period, subjects were crossed over to the alternate treatment. Decreased active metabolite exposure and increased platelet aggregation were observed in the poor metabolizers compared to the other groups. When poor metabolizers received the 600 mg loading dose followed by 150 mg daily, active metabolite exposure and antiplatelet response were greater than with the 300 mg/75 mg regimen. Healthcare professionals should note that an appropriate dose regimen for patients who are poor metabolizers has not been established in clinical outcome trials.
-Related Information
• Information on Clopidogrel Bisulfate (marketed as Plavix)
• Podcast for Healthcare Professionals: Reduced effectiveness of Plavix in patients who are poor metabolizers of the drug ".... keywords: plavix, drug stent, stent, drug eluting stent, heart-
- Prophylaxis of venous thromboembolism in IBD The Lancet keywords: accutane, IBD, inflammatory bowel disease, venous thromboembolism (VTE) -
- YAZ label change-4/7/2010: (FDA) (risks of thromboembolism in women using a different drospirenone-containing pill) keywords: yaz, yasmin, heart attack, stroke, pulmonary embolism, deep vein thrombosis (dvt)-
- US Supreme Court To Hear Costco Appeal In Copyright Case: Fox An excerpt from the article states that "WASHINGTON -(Dow Jones)- The U.S. Supreme Court agreed Monday to decide if Costco Wholesale Corp. (COST) can be held liable for copyright infringement for re-selling luxury Swiss watches it obtained through second-hand sources. The case could have considerable implications for discount stores and companies like eBay Inc. (EBAY) and Amazon.com Inc. (AMZN) that facilitate the re-sale of cds, books, movies and a host of other goods. At issue is a lawsuit filed by Omega SA, a unit of The Swatch Group Ltd., alleging that Costco violated U.S. copyright law in 2004 by selling Omega Seamaster watches it obtained from third parties who had imported them into the U.S. Costco sold the watches for $1,299, well below Omega's suggested retail price of $1,999. The watches were engraved with a small emblem Omega had registered with the U.S. Copyright Office. Costco argued that Omega could not impose any limits on how its watches are re-sold once the watchmaker made its first sale of the goods. In this case, Omega sold the watches to overseas distributors and the products eventually were re-sold to a New York company that sold them to Costco. A federal judge in California sided with Costco, but an appeals court overturned that decision and sided with Omega in 2008, saying the watchmaker retained rights to products that it made and sold abroad which were later imported into the U.S. ".... keywords: copyright, intellectual property, infringement, copyright infringement-
- Yasmin, Yaz Birth Control Subject of Lawsuits: (WSJ) An excerpt from the article states that "Some 1,100 lawsuits have been filed against Bayer HealthCare claiming health risks from its Yasmin and Yaz brand birth control pills, according to the L.A. Times. But is there any evidence behind the claimed problems, which include dangerous blood clots, strokes, heart attacks and gallbladder disease? Well, nothing definitive – research on the effects of the purported culprit in Yaz, a synthetic progestin called drospirenone, is mixed. “Some studies have found drospirenone to pose no greater health risk than other birth control pills; some studies show a sixfold greater risk of getting blood clots, even in young, healthy women,” the LAT says. Bayer says the drugs are safe and effective. ".... keywords: yaz, yasmin, heart attack, stroke, pulmonary embolism, deep vein thrombosis (dvt)-
- FDA Mulling End to Avandia-Actos Trial on Safety Worries: (WSJ) An excerpt from the article states that "The FDA is considering cutting short a trial comparing the safety of two diabetes drugs — GlaxoSmithKline’s Avandia and Takeda’s Actos, the WSJ reports. Given that Avandia has been linked since 2007 to an increased risk of heart attacks, some scientists have said it’s not ethical to put study participants at risk. If the trial is stopped, the FDA will also consider asking Glaxo to stop selling the drug. Joshua Sharfstein, principal deputy commissioner of the FDA, tells the WSJ that no decision on the trial (called TIDE) has been made yet, and won’t be until after a July meeting about the drug. By then the agency will also have the results of an Institute of Medicine review examining the appropriateness of such head-to-head safety trials. ".... keywords: avandia, diabetes, heart attack, stroke-
- Avandia: What Should Patients Do?: (WSJ) An excerpt from the article states that "Diabetes doctors are facing a new round of questions from worried patients after findings of a Senate investigation that renewed concerns about the safety of Avandia. What should the patients do? Dr. Richard Bergenstal, executive director of the International Diabetes Center in Minneapolis, tells the Health Blog that the most important thing is that patients stay on whatever medicines they are taking until talking things through with their doctors. Skipping or dropping treatment altogether could worsen their diabetes. Better they first review their options with their endocrinologist. “There are a lot of medications, and we can discuss the options. The last thing we want is someone to be stressed,” said Dr. Bergenstal, who is also president of medicine and science at the American Diabetes Association. Physicians typically prescribe drugs like Avandia to patients whose diabetes isn’t well controlled by improvements to diet and exercise and by the medicine called metformin that is often prescribed first. Diabetics and their doctors have been here before. Concerns that people taking Avandia have a higher chance of suffering a heart attack than patients taking other diabetes pills surfaced in 2007. ".... keywords: avandia, diabetes, heart attack, stroke-
- FDA Mulls Killing Safety Study on Diabetes Drug: (Fox) An excerpt from the article states that "U.S. regulators are considering ending a safety study on GlaxoSmithKline's diabetes drug Avandia, the Wall Street Journal reported on Sunday, saying the move could also jeopardize the drug's presence in the U.S. market. Avandia has been in the spotlight because of concerns that the drug increases heart attack risks. U.S. Senators Max Baucus and Charles Grassley released a report on the drug in February as well as internal FDA documents, including a 2008 memo from two FDA drug safety reviewers who recommended pulling the drug from the U.S. market. Glaxo has said the scientific evidence did not establish that Avandia increased heart attack risks and added it had been open in providing information about the drug. According to the Wall Street Journal report, FDA commissioner Margaret Hamburg wrote a letter to Grassley in late March saying that the agency is reassessing a trial that compares the drug to a drug made by Takeda Pharmaceutical Co called Actos. That trial is also called the TIDE trial, according to the Journal. ".... keywords: avandia, diabetes, heart attack, stroke-
- Electrocution suspected at Daly City gas station: (SF Chronicle) An excerpt from the article states that "A 19-year-old man died today at a Daly City gas station, and police said he appears to have been electrocuted. Mustafa Algazawy of San Francisco died at a hospital following the incident, which occurred around 1:20 p.m. at a 76 station on South Mayfair Avenue, near Interstate 280 and John Daly Boulevard. ".... keywords: personal injury-
- Shell Confirms Worker's Death At Refinery In Texas: Fox An excerpt from the article states that "Royal Dutch Shell (RDSA, RDSA.LN) said Monday that a worker died at the Motiva Port Arthur refinery it operates in Texas. The worker's death "can be confirmed, and we are investigating what the cause was," a Shell spokeswoman said. No further details were available, but the company said a statement will be issued soon. The Jefferson County Sheriff's Office was dispatched at 8:55 a.m. local time "in regard to an industrial accident at a construction site" at the Motiva refinery, said Brent Weaver, assistant to the sheriff. A male worker was found dead upon arrival, and the cause is under investigation per standard procedures, he added. "We don't know cause of death, and a justice of the peace has been sent out to the scene," Weaver said. ".... keywords: refinery, plant explosion,-
- Birth control pill concerns bring lawsuits but few solid answers LA TimesAn excerpt from the article states that "Yaz and Yasmin complaints focus on the synthetic progestin, drospirenone. Studies have not found an increased risk with these pills, though. When the oral contraceptives Yasmin and Yaz came on the market in 2001 and 2006, respectively, they were thought to be safer than other birth control pills because they contained a different kind of synthetic progestin. But in a flurry of lawsuits against the pills' maker, Bayer HealthCare, attorneys claim that the progestin contained in the pills, drospirenone, is the cause of health problems, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease. As of mid-February, about 1,100 lawsuits had been filed in the United States against Bayer, which stands behind the safety of the pills. Research on the issue is divided. Some studies have found drospirenone to pose no greater health risk than other birth control pills; some studies show a sixfold greater risk of getting blood clots, even in young, healthy women. More research is being performed on the safety of the contraceptives, but for now, women considering taking the pills will need to weigh the contradictory information themselves. "There is reason to be concerned, I believe, about both of them [Yaz and Yasmin]," said Dr. Sidney Wolfe, founder and director of Public Citizen's Health Research Group, a nonprofit advocacy organization based in Washington, D.C. "When evidence like that comes up, people should pay attention to it." SUBHEAD Oral contraceptives control unwanted pregnancies by using hormones that block ovulation. The first of these pills, introduced in the United States in the early 1960s, contained high doses of estrogen. They were quickly found to raise the risk of stroke, blood clots and heart attacks. Second-generation pills introduced in the 1970s contained lower amounts of estrogen combined with synthetic progestins, including one called levonorgestrel. These reduced the risk of blood clots but caused side effects such as weight gain and acne in many women. The 1980s brought third-generation pills containing different synthetic progestins, such as one called desogestrel. These were later found to be associated with a higher risk of deep vein thrombosis and pulmonary embolism. The fourth-generation pills — Yaz, Yasmin and Ocella, a generic version — contain estrogen and yet another progestin, drospirenone. They were created not just to prevent pregnancy but to also reduce the side effects of previous pills and to treat premenstrual dysphoric disorder (severe cases of depression, anxiety, headaches and other symptoms). Yaz is now the No. 1-selling birth control in the United States, grossing more than $391 million in the first half of 2009, up 44% from the same time period in 2008, according to health data provider IMS Health. Bayer received a warning from the FDA last year for overstating Yaz's effectiveness in treating PMDD and acne while minimizing the risks of the medication on its website and television commercials. In response, the company altered its advertising. Now the contraceptives are not just the subject of lawsuits, they're also under scrutiny by groups such as Public Citizen over their safety. The FDA is testing the safety of Yaz and other pills in an ongoing study. ".... keywords: yaz, yasmin, blood clot, pulmonary embolism, deep vein thrombosis-
For more on Yaz, see Yaz or Yaz or yasmin
- New legal trick: Fake hospital sites for finding client FortuneAn excerpt from the article states that "(Fortune) -- Until about noon on Wednesday, dozens of websites were identifying themselves with a Red Cross-ish logo and names like "VA Medical Center Palo Alto," or "VA Hospital San Francisco," or "VA Medical Center Gainesville" though they had no affiliation with the U.S. Department of Veterans Affairs. They were actually operated by plaintiffs law firms that were searching for clients with asbestos-related diseases. The sites were designed in ways that might easily confuse elderly and infirm veterans into falsely believing that the VA itself was recommending that they see certain lawyers if they suffered from asbestos-related illnesses. (Unfortunately, this article is not an April Fool's joke.) Many veterans were exposed to asbestos during their service in World War II, Korea, and Vietnam. Because those dying from an asbestos-related cancer called mesothelioma (nearly 100% fatal) may be entitled to large awards from former asbestos manufacturers or their bankruptcy trusts, contingent-fee lawyers -- who are paid a percentage of their clients' recoveries -- have strong financial incentives to find and sign up such clients.
I started making inquiries of the three firms listed as "sponsoring" these sites -- including a prominent New York-based pharmaceutical and medical device plaintiffs firm known as Seeger Weiss -- on mid-afternoon Tuesday. None of the firms initially got back to me but by Wednesday morning the sites had received a modest facelift, adding a tiny disclaimer at the top of each home page stating "Not Affiliated with the Department of Veterans Affairs." At the bottom, a second disclaimer had also been added in small, faint-gray print. It stated that the site was "sponsored by" Seeger Weiss and two other law firms, identified only as the Flood Law Office and Melinda J. Helbock, APC. (Prior to my calls, the information was provided only if the reader clicked on a similarly faint-gray link labeled "disclaimer.") Each site purported to be copyrighted by the "VA Medical Center" in question. ....keywords: asbestos, mesothelioma, lung cancer-
For more on information, see Legal Sleuth® or Gooch Law Firm
- Straw defends asbestos ruling The HeraldAn excerpt from the article states that "JUSTICE Secretary Jack Straw has denied 'abandoning' former Devonport dockyard workers suffering from an asbestos-related disease after deciding not to overturn a legal ruling blocking compensation. The Secretary of State insisted the medical evidence did not support changing a Law Lords ruling that prevents sufferers of pleural plaques – a scarring of the lungs caused by exposure to asbestos – claiming payouts. Plymouth is a hotspot for asbestos-related deaths, many of them former workers at Devonport. City law firm Wolferstans was among those to criticise Mr Straw's decision back in February to uphold the Law Lords ruling in 2007, branding it a 'fudge.' The House of Lords ruling is estimated to have saved insurers £1.4billion. Tackled by the Herald at Westminster, Mr Straw insisted the Government had not let down dockyard workers, saying people who had already started a legal claim for compensation would be given a £5,000 payment, and pointing to the commitment of £3million towards a National Centre for Asbestos-Related Disease, and plans to look into the establishment of an Employers' Liability Insurance Bureau as a fund of last resort to compensate injured workers.” ....keywords: asbestos, mesothelioma, lung cancer-
For more on information, see Legal Sleuth® or Gooch Law Firm
- Mesothelioma is a rare cancer, but early diagnosis.../strong> The BulletinAn excerpt from the article states that "Last month, when former football and television star Merlin Olsen died of mesothelioma at age 69, it was the first many Americans had heard of the disease. Mesothelioma is a rare cancer that affects the thin layer of tissue that covers most internal organs. The most common form, affecting the lungs, is what killed Olsen. According to the American Cancer Society, 2,000 to 3,000 Americans are diagnosed with the condition each year. Symptoms include shortness of breath, painful breathing or coughing, chest pain under the rib cage, unusual lumps of tissue under the skin on your chest, and unexplained weight loss. People who worked with asbestos are thought to be at greatest risk of mesothelioma, probably from inhaling the fibers.” ....keywords: asbestos, mesothelioma, lung cancer-
For more on information, see Legal Sleuth® or Gooch Law Firm
- Eli Lilly's Chemotherapy Drug Alimta RTT NewsAn excerpt from the article states that "Thursday, Eli Lilly & Co.(LLY: News ) said its chemotherapy Alimta received a positive "Final Appraisal Determination" from the United Kingdom's National Institute for Health and Clinical Excellence or NICE. NICE's Final Appraisal Determination recommended Alimta as an option for the maintenance treatment of people with locally advanced or metastatic non-small cell lung cancer with other than predominantly squamous cell histology if disease has not progressed immediately following platinum-based chemotherapy first-line chemotherapy.Globally, lung cancer is indicated as the most common form of cancer and the biggest killer, causing 1.3 million cancer deaths annually. The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.” ....keywords: asbestos, mesothelioma, lung cancer-
For more on information, see Legal Sleuth® or Gooch Law Firm
- Study finds possible heart risk with prostate drug Huron TribuneAn excerpt from the article states that "Full results of a big study testing a drug for preventing prostate cancer show a higher risk of heart failure, a surprise finding that could dampen enthusiasm for expanding its use. On Monday, GlaxoSmithKline PLC asked the federal Food and Drug Administration to approve its drug Avodart as a cancer preventive for men at higher-than-normal risk of the disease. The drug is already sold for urinary problems, and no heart failure risks have been seen with that use, doctors say.Results of a study testing it as a cancer preventive were given at a medical conference last year, but the heart risk information had not been analyzed at that time so only the main results of the study were presented, a Glaxo spokeswoman said. Full results are being published in Thursday's New England Journal of Medicine.The study involved 6,700 men with high scores from PSA blood tests but no sign of cancer on biopsy. They were given Avodart or dummy pills and new biopsies four years later. Prostate cancer was found in 25 percent of those on dummy pills and 20 percent of those on Avodart.That's the same risk reduction as other studies have found from a similar drug, finasteride, sold in generic form and as Proscar, made by Merck & Co. Inc. Studies did not find an increased risk of heart failure with Proscar. In the Avodart study, heart failure developed in 30 men on the drug versus only 16 on dummy pills.Further analysis suggests that men who developed heart failure while on Avodart also tended to be taking certain other drugs, said Glaxo spokeswoman Sarah Alspach. The higher heart failure rate in this study "is unexpected and inconsistent" with previous research, she said.” ....keywords: -
For more on information, see Legal Sleuth® or Gooch Law Firm
- Study links chemical exposure to breast cancer ReutersAn excerpt from the article states that "In a study in Occupational and Environmental Medicine, a British Medical Journal title, the researchers found that women exposed to synthetic fibers and petrol products during the course of their work appeared to be most at risk. "Occupational exposure to acrylic and nylon fibers, and to polycyclic aromatic hydrocarbons may increase the risk of developing postmenopausal breast cancer," they wrote. But some experts commenting on the study expressed caution, saying such links can crop up by chance. "In a study of this sort positive associations often occur simply by chance," said David Coggon, a professor of occupational and environmental medicine at Britain's Southampton University. "They carry little weight in the absence of stronger supportive evidence from other research." The Canadian scientists conceded their findings could be due to chance, but also said they were consistent with the theory that breast tissue is more sensitive to harmful chemicals if the exposure occurs when breast cells are still active -- in other words, before a woman reaches her 40s..” ....keywords: -
For more on information, see Legal Sleuth® or Gooch Law Firm
- Pfizer Paid Doctors, Hospitals $35 Million WSJAn excerpt from the article states that "IPfizer Inc. said Wednesday it paid about 4,500 doctors and hospitals $35 million during the second half of last year to study how the company's medicines work and to promote the treatments, in its first public disclosure of payments to the professionals and institutions that test and prescribe its products.” ....keywords: -
For more on information, see Legal Sleuth® or Gooch Law Firm
- Gov't set to ban texting by truck, bus drivers APAn excerpt from the article states that "The Transportation Department on Wednesday proposed a ban on text messaging at the wheel by interstate truck and bus drivers, following up on its call to reduce distractions that lead to crashes. The proposal would make permanent an interim ban announced in January by Transportation Secretary Ray LaHood, applying to drivers of buses and commercial trucks over 10,000 pounds. The drivers could face civil or criminal penalties.The proposal "keeps our commitment to making our roads safer by reducing the threat of distracted driving," LaHood said. As navigation systems, cell phones and mobile electronics have become ubiquitous in cars and trucks, safety advocates and the government have pushed for restrictions. The Transportation Department reports that 5,870 people were killed and 515,000 injured in 2008 in crashes connected to driver distraction, often involving mobile devices or cell phones. Trucking and bus industry officials support the texting ban and many companies already have policies in place against texting behind the wheel. The government prohibition doesn't apply to onboard devices that allow dispatchers to send text messages to truck drivers, but industry officials say most of the devices have mechanisms preventing their use while a truck is moving. Twenty states and the District of Columbia already prohibit all drivers from texting behind the wheel, according to the Governors Highway Safety Association. Another nine states restrict texting by novice drivers. The government, industry and safety organizations have found common ground on texting and driving, concerned that typing out a message on a mobile device can take a driver's eyes off the road for a dangerous number of seconds. Research by the Federal Motor Carrier Safety Administration shows that drivers who send and receive text messages take their eyes off the road for an average of 4.6 seconds out of every 6 seconds while texting. At 55 miles per hour, that means the driver is traveling the length of a football field without looking at the road. Texting has grown exponentially in recent years and become a favorite form of communication among teens. The wireless industry association CTIA reported that the number of text messages sent by its members' customers increased from 32.6 billion in the first six months of 2005 to 740 billion in the first six months of 2009.” ....keywords: truck accident, bus accident, 18 wheeler accident -
For more on Truck/18 wheeler accidents, see Truck and 18 wheeler accidents at Legal Sleuth® or Truck and 18 wheeler accidents at Gooch Law Firm
- Titleist Wins Decision in Pro V1 Patent Dispute with Callaway: (Yahoo) YahooAn excerpt from the article states that "Acushnet Company, the golf business of Fortune Brands, Inc. (NYSE: FO - News), and manufacturer of Titleist, the #1 ball in golf, announced that it won a jury verdict in the U.S. District Court for the District of Delaware in its golf ball patent dispute with Callaway Golf Co.. Callaway asserted that previous generation Titleist Pro V1 golf balls had infringed on four patents originally owned by Spalding and subsequently purchased by Callaway Golf. The jury agreed with Acushnet’s position that the patents in question are invalid.” ....keywords: patents, intellectual property, infringement, patent infringement -
For more on Intellectual Property - Patent disputes and infringement, see Intellectual Property - Patent disputes and infringement at Legal Sleuth® or Intellectual Property - Patent disputes and infringement at Gooch Law Firm
- Many Avandia defenders have drug co. ties: study (Reuters) ReutersAn excerpt from the article states that "Virtually all of the experts who wrote favorably about GlaxoSmithKline Plc's troubled diabetes drug Avandia had financial ties to drug makers, a finding that shows the need for reform of such relationships, U.S. researchers said on Thursday. HEALTH A team at the Mayo Clinic in Rochester, Minnesota, pored through more than 200 scientific studies and commentaries that offered positive opinions about the drug after a May 2007 study suggested Avandia significantly increased the risk of heart attacks. They found that 94 percent of the authors who defended the drug, known generically as rosiglitazone, had ties to drug companies, and nearly half had financial ties that presented a conflict of interest. "It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion about the medication," Dr Victor Montori of the Mayo Clinic, whose study appears in the British Medical Journal, said in a telephone interview. Montori looked at the financial relationships of researchers who had ties with pharmaceutical companies in general, and particularly those who wrote about rosiglitazone or the rival drug pioglitazone, made by Takeda Pharmaceutical Co Ltd under the brand name Actos.
"If you were to look at the proportion of people with favorable opinions, 94 percent of them had a relationship with a pharmaceutical company," Montori said. "If you were to look at the folks with an unfavorable opinion, 28 percent had a relationship with a pharmaceutical company," he said. FAILURE TO REPORT The team checked both disclosures in scientific papers that mentioned Avandia and other papers by the same authors. About a quarter of those did not report that relationship in the paper that was about Avandia. "If the public was directly looking at financial relationships in the studies of interest, that information will not be present in a fourth of those studies," Montori said. The Mayo team's findings "underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted," the researchers wrote. Glaxo spokeswoman Mary Anne Rhyne defended the drug. "Of the 202 publications reviewed by the authors, only 10 were original scientific research," she said in a statement. "Many of the articles reviewed were opinion pieces -- editorials, commentaries or letters. It is important to note that the authors' conclusions do not impugn the validity of the scientific data," she said. Montori said the results were essentially the same if the researcher had a relationship with the maker of Avandia or the competing drug Actos, although they looked harder at research on Avandia. "The reason is, it seems, there is a large overlap in the investigators who write opinions about these drugs that are funded by both companies," he said. Montori said it is not clear whether having financial ties to a drug company influences a researcher's opinion, or whether drug companies seek out investigators who already have a good opinion of their drug and fund their studies. What is clear, he said, is that drug company ties do appear to influence scientific opinion about the safety of drugs, and this issue may play a role in the debate about a drug's safety.” ....keywords: avandia, heart attack, fracture, bone fracture -
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- Long-term safety of drug-coated stents questioned (Reuters) ReutersAn excerpt from the article states that "New research shows more patients who got drug-coated stents right after suffering a severe heart attack later died from heart-related problems than those who received older, cheaper bare-metal models.
Seven years after the first drug-coated stent was approved in the United States, heart doctors gathering in Atlanta for the American College of Cardiology meeting debated the issue, saying more research is needed to understand the long-term effects. Danish researchers conducted a trial of more than 600 patients examining the effectiveness and risks of the two types of stents implanted right after a major heart attack. They found that after three years, patients who got bare-metal stents were more likely to have problems, such as requiring more intervention for blockages, while patients with the drug-coated variety were more likely to die from heart-related problems. More than 6 percent of patients in the study who got the drug-coated stent died, compared with nearly 2 percent who got the bare metal stent, researchers said. "The key message here is that we have shown that despite a finding of lower major adverse cardiac events, cardiac mortality was significantly higher in the drug-eluting stent group," said Dr. Peter Clemmensen of Copenhagen University Hospital.” ....keywords: drug eluting stent, heart stent, drug stent, stent, heart attack -
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- FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures (FDA) FDAAn excerpt from the article states that "[03-10-2010] Patients and healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax, Actonel, Boniva, and Reclast. Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue. Based on published case reports of atypical subtrochanteric femur fractures occurring in women with osteoporosis using bisphosphonates, FDA, in June 2008, requested information from all bisphosphonate drug manufacturers regarding this potential safety signal. All available case reports and clinical trial data were requested. FDA's review of these data did not show an increase in this risk in women using these medications. In addition, FDA reviewed a December 2008 article in the Journal of Bone and Mineral Research by Abrahamsen et al1, that analyzed data from two large observational studies in patients with osteoporosis. The authors concluded that atypical subtrochanteric femur fractures had many similar features in common with classical osteoporotic hip fractures, including patient age, gender, and trauma mechanism. The data showed that patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures. This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will continue to review new information as it becomes available and will update the public once the agency's review is complete. Healthcare professionals should continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications. Additional Information for Patients If you currently take an oral bisphosphonate you should: Not stop taking your medication unless told to do so by your healthcare professional. Talk to your healthcare professional if you develop new hip or thigh pain or have any concerns with your medications. Report any side effects with your bisphosphonate medication to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.
Additional Information for Healthcare Professionals FDA recommends that healthcare professionals should: Be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates. Continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Discuss with patients the known benefits and potential risks with using oral bisphosphonates. Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box. References: 1. Abrahamsen B., Eiken P., Eastell R. Subtrochanteric and Diaphyseal Femur Fractures in Patients Treated With Alendronate: A Register-Based National Cohort Study. J Bone Miner Res. 2009 Jun;24(6):1095-102.” ....keywords: fosamax, ostenecrosis -
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- Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures (FDA) FDAAn excerpt from the article states that "Orthopedic healthcare professionals, patients [Posted 03/11/2010] FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications. [03/10/2010 - Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures - FDA]
” ....keywords: fosamax, ostenecrosis -
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- UPDATE 1-Glaxo fires off 30-page rebuttal of Avandia claims (Reuters) ReutersAn excerpt from the article states that "Rejects allegations of concealing safety information * Says Senate report improperly casts Avandia as unsafe(Adds detail on Glaxo report, quotes) LONDON, Feb 24 (Reuters) - GlaxoSmithKline (GSK.L) stepped up the defence of its diabetes drug Avandia on Wednesday with a detailed 30-page response rejecting a critical report by U.S. lawmakers. The drugmaker said the Senate finance committee report did not present "an accurate, balanced, or complete view" of information about the drug and the company rejected allegations it had concealed safety data (link.reuters.com/bar62j). A spokeswoman for Glaxo, which issued a press release on Feb. 20 rejecting the committee's conclusion that Avandia was unsafe, said the lengthy "white paper" was the company's official response.” ....keywords: avandia, heart problems, heart attack, bone fracture-
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- A Face-Off on the Safety of a Drug for Diabetes (NY Times) NY TimesAn excerpt from the article states that "Three years ago, Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales and a plunge in the share price of GlaxoSmithKline, Avandia’s maker. The battle between Dr. Nissen and GlaxoSmithKline was waged from afar in news releases and published papers. But on May 10, 2007, 11 days before Dr. Nissen’s study was published in The New England Journal of Medicine, he and four company executives met face to face in a private meeting whose details have not been disclosed until now. Fearing he would face pressure and criticism from executives, Dr. Nissen secretly recorded the meeting — which is legal in Ohio as long as one party to the conversation is aware of the taping. On a recent day in his sunny office at the Cleveland Clinic, Dr. Nissen shared the contents of the recording with The Times. What was said at the 2007 meeting raises questions about science and ethics that have suddenly become keenly relevant. A Congressional investigation released Saturday concluded that GlaxoSmithKline had threatened scientists who tried to point out Avandia’s risks, and internal memorandums from the Food and Drug Administration show that some government health officials want Avandia withdrawn. The drug is still being taken by hundreds of thousands of patients, and sales last year were $1.19 billion. ” ....keywords: avandia, heart problems, heart attack, bone fracture-
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- Toyota Slapped with Subpoenas for Documents Related to Brake, Acceleration Problems (Fox) FoxAn excerpt from the article states that "Federal prosecutors have opened a criminal investigation into Toyota's safety problems, the company acknowledged Monday as it prepared to answer questions on Capitol Hill about its widespread vehicle recalls. The Japanese automaker said it received a subpoena from a federal grand jury in New York seeking documents related to unintended acceleration in its vehicles and the braking system of its Prius hybrid. Toyota also said it received a subpoena and a voluntary document request from the Los Angeles office of the U.S. Securities and Exchange Commission. The SEC is seeking documents related to unintended acceleration as well as to its disclosure policies and practices, Toyota said. The subpoenas are the latest demand for documentation from Toyota Motor Corp. Over the weekend, the company turned over documents to congressional investigators, with some boasting it saved money by obtaining a limited recall from regulators in 2007. The documents could create a big challenge for Toyota President Akio Toyoda, who is scheduled to testify at a House Oversight and Government Reform Committee on Wednesday. Two House committees are holding hearings this week on the Japanese automaker's recall of 8.5 million vehicles since the fall to deal with safety problems involving gas pedals, floor mats and brakes.” ....
- Mom's antidepressants may delay baby's first steps (Reuters) ReutersAn excerpt from the article states that "When pregnant women take antidepressants, it sometimes causes their babies to hit developmental milestones late, Danish researchers reported on Monday. However, the delays--up to one month--still place the toddlers within the normal range of development. "These drugs have an effect on the fetus' brain," said Dr. Lars Henning Pedersen, who worked on the study. But, he said, the delays "may not matter for the child at all." Pedersen, from Aarhus University Hospital in Denmark, spoke to Reuters Health in a telephone interview. Today, as many as one in six pregnant women in the US are diagnosed with major depressive disorder, and most are treated with antidepressants such as Prozac, Zoloft or Paxil. The brain chemical targeted by these drugs--called serotonin--is involved in a host of biologic functions, from mood, to attention, to appetite and general brain development. While medicines that ratchet up serotonin levels help dampen depressive symptoms, it is not well understood how a human fetus reacts to such drugs, or how long their potential effects last. In the lab, for example, scientists have found that antidepressants given to a pregnant rat stifle the natural exploratory behavior of her offspring well into adulthood. For their study, published in the journal Pediatrics, Pedersen and his colleagues tapped into a nation-wide Danish database of more than 100,000 pregnancies. They identified some 400 women who took antidepressants during pregnancy as well as nearly 500 who were not on medication despite being depressed. Based on the women's own reports, the researchers then compared how many children in each group hit developmental milestones such as sitting without support, looking after sounds and venting irritation.” ....keywords: paxil, birth defects, birth injuries, septal defect, septal heart defect, pphn, Persistent Pulmonary Hypertension of Newborn (PPHN) -
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- Senate report: Avandia maker knew of cardiac risks (AP) APAn excerpt from the article states that "A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. The agency ordered a warning to be included on Avandia's label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive. Soon afterwards Sen. Grassley, one of the FDA's toughest critics in Congress, disclosed that the agency's internal safety experts came within one vote of recommending a withdrawal of Avandia. The Senate report suggests sharp disagreements remain at the FDA over how to handle Avandia's risks.” ....keywords: avandia, heart problems, heart attack, bone fracture-
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- Glaxo to remove zinc from denture cream (Projo.com) ProjoAn excerpt from the article states that "The maker of Poligrip denture cream will stop making formulas containing zinc amid lawsuits claiming years of excessive use caused neurological damage and blood problems in consumers, allegedly crippling some. GlaxoSmithKline will stop making and marketing Super Poligrip Original, Ultra Fresh and Extra Care products in the U.S. The company plans to reformulate the creams without zinc. The company, based in London, reported more than $520 million in denture adhesive sales last year. It stressed that the products are safe when used as directed, but that some people use extra cream to correct ill-fitting dentures. Glaxo's voluntary action comes as hundreds of lawsuits are poised to go to trial, alleging Poligrip caused nerve damage, leading to a loss of balance, loss of sensation in the hands and feet, and leaving some patients paralyzed. "They made the right decision in the sense that it's going to prevent the crippling of more people," said attorney Andy Alonso of Parker Waichman Alonso LLP. "But it's too late for many of my clients." Alonso represents more than a hundred users of denture cream in Miami federal court, where several hundred lawsuits are being consolidated. The plaintiffs say the makers of zinc-based creams failed to warn consumers about potential risks. Alonso estimates about 30 million people in the U.S. wear dentures and use products like Poligrip..” ....
- Controversial Diabetes Drug Harms Heart, U.S. Concludes (NY Times) NY TimesAn excerpt from the article states that "Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009. “Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn. The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks. The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks. Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice..” ....keywords: avandia, heart attack, diabetes -
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- Information on Gadolinium-Containing Contrast Agents (FDA) FDAAn excerpt from the article states that "The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
For more on gadolinium, contrast agent or NSF, see Gadolinium or NSF at Legal Sleuth® or Gadolinium, Contrast agent or NSF at Gooch Law Firm
- Questions and Answers on Gadolinium-Containing Contrast Agents 12/22/2006 (FDA) FDAAn excerpt from the article states that "1. What information is new since the Questions and Answers from June 2006? FDA’s previous information was limited to 25 cases in patients that received Omniscan for Magnetic Resonance Angiography (MRA) at doses higher than approved and recommended for Magnetic Resonance Imaging (MRI).
FDA has received an additional 65 case reports of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients who received Magnevist, Omniscan, and OptiMARK for MRI and MRA. NSF/NFD has now been reported in patients who received the recommended doses of the contrast agents. Researchers have found gadolinium deposits in the skin of patients who developed NSF/NFD. 2. What is gadolinium and what is its use in clinical medicine?
Gadolinium is a paramagnetic metal ion. Paramagnetic ions, such as gadolinium, tend to move into magnetic fields. This trait makes paramagnetic ions such as gadolinium useful for MRI and MRA. Gadolinium-based contrast agents are manufactured by a chelating process, a procedure in which large organic molecules form a stable complex around the gadolinium. The chelate reduces the chances of toxicity that could result from exposure to free gadolinium. This stable complex is eliminated via the kidneys in patients with normal functioning kidneys. Gadolinium-based contrast agents are approved by FDA for use with MRI as a contrast agent to provide an improved image of body organs and tissues. Gadolinium-based contrast agents are also used for MRA, another imaging procedure used to evaluate blood vessels. 3. What is the difference between MRA and MRI? MRA is a special type of MRI used to study blood vessels. MRA is utilized to aid in the detection of heart disorders, stroke, and vascular diseases. 4. Can an MRI and MRA be performed without gadolinium-based contrast? Yes, MRI and MRA can be performed without contrast. MRI with gadolinium-based contrast agents provides additional diagnostic information as compared to MRI without contrast. The use of gadolinium-based contrast agents in MRA is not FDA approved. MRA with gadolinium-based contrast is thought by many radiologists to provide more detailed images of blood vessels than MRA without gadolinium-based contrast. 5. Are there any FDA approved MRA contrast agents? No. 6. Are there other approved MRI contrast agents that do not contain gadolinium? Yes. However, the two other approved MRI contrast agents, Feridex, I.V. (an iron-containing injectable solution) and Teslascan (a manganese-containing injectable solution) are FDA-approved only for the evaluation of lesions of the liver. Imaging contrast agents, such as iodinated contrast agents are used in Computed Tomography, plain X-ray and X-ray angiography. However, these iodinated contrast agents require X-ray imaging rather than MRI. 7. What is the concern regarding gadolinium-based contrast agents? Patients with moderate (glomerular filtration rate less than 60 mL/min/1.73m2) to end-stage (glomerular filtration rate less than 15 mL/min/1.73m2 or on dialysis) kidney disease who receive gadolinium-based contrast agents are at risk for developing a serious systemic fibrosing disease called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). As of December 21, 2006, FDA has received 90 reports of NSF/NFD in patients who received gadolinium-based contrast agents for MRI and MRA. In addition, researchers have found gadolinium deposits in the skin of patients with NSF/NFD. The association between NSF/NFD was first reported in a May 29, 2006, press release from the Danish Medicines Agency (DMA) and the April 2006 report by Grobner et al in Nephrology, Dialysis and Transplantation (2006) Vol 21 (4):1104-1108 and following erratum (2006) 21(6): 1745. 8. What is Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD)? NSF/NFD was first described in the medical literature in 2000. The first case of NSF/NFD was identified in 1997. The disease is observed in patients that have moderate to end-stage kidney disease. NSF/NFD causes fibrosis of the skin and connective tissues throughout the body. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility of joints. NSF/NFD usually starts in the lower extremities. Fibrosis can also develop in the diaphragm, muscles in the thigh and lower abdomen, and lung vessels. The clinical course of NSF/NFD is progressive and may be fatal. 9. What is the treatment for NSF/NFD? There is no known treatment for NSF/NFD. Improved renal function (spontaneous or via renal transplantation) appears to slow or arrest NSF/NFD and may even result in a gradual reversal of NSF/NFD. Other treatments are being tested. 10. How many gadolinium-based contrast agents has FDA approved? Was NSF/NFD seen with all of the U.S.-approved gadolinium-based contrast agents? There are five FDA approved gadolinium-based contrast agents (Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance). Of the 90 cases of NSF/NFD FDA has received, most have been associated with the administration of Omniscan. Other cases, however, have been associated with Magnevist and OptiMARK exposure. Although NSF/NFD has been reported for only 3 of the 5 gadolinium-based contrast agents, FDA believes that NSF/NFD may occur with the use of any of the approved gadolinium-based contrast agents.
11. Do the gadolinium-based contrast agents cause NSF/NFD? Whether the gadolinium-based contrast agents are the only agents or conditions that may be associated with NSF/NFD in patients with renal disease is unknown. However, the 90 case reports FDA has received and the finding of gadolinium deposits in the skin of patients with NSF/NFD suggests that gadolinium-based contrast is a factor in the development of NSF/NFD in patients with moderate to end-stage kidney disease.
12. What actions will FDA take regarding the new information about gadolinium-based contrast agent administration and the development of NSF/NFD in patients with moderate to severe kidney disease? FDA is continuing to evaluate the 90 case reports, is having ongoing discussions with NSF/NFD experts, is reviewing results of clinical trials with gadolinium-based contrast agents, and is working with the manufacturers to review all safety reports and adverse event reports. FDA will be initiating labeling changes for gadolinium-based contrast agents. 13. What information was known about serious side effects prior to the approval of gadolinium-based contrast agents? The five U.S. approved gadolinium-based contrast agents were approved between 1988 and 2004. In the combined pre-marketing studies for these approved gadolinium-based contrast agents, over 3000 patients were studied. The most common serious side effect from gadolinium-based contrast agents is an allergic reaction that is usually mild but is occasionally severe and even results in fatalities. Some patients develop skin conditions, such as rash, sweating, itching, hives, and facial swelling. Most of these conditions are allergic in nature. Gadolinium-based contrast agents can be very irritating to the veins into which they are injected, causing irritation of blood vessels and skin and the formation of blood clots. Very few patients with severely compromised kidney function or those on dialysis have been studied in clinical trials. The labels for gadolinium-based contrast agents caution that the risk of toxic reactions may be greater in patients with impaired kidney function because gadolinium is mostly excreted by the kidney. 14. What should patients do with this new information? If you have moderate to end-stage kidney disease and a physician has requested an MRI or MRA study with a contrast agent, ask if there are other contrast agents that could be used or other diagnostic tests that could be done. If gadolinium-containing contrast agents are necessary, physicians and patients should carefully select the contrast agent based on the individual patient’s medical care needs. If you have moderate to end-stage kidney disease and you received a gadolinium-based contrast MRA, you should tell your doctor. Call your doctor right away if any time after your gadolinium injection you get any of these conditions Skin and eyes Swelling, hardening and tightening of your skin Reddened or darkened patches on the skin Burning or itching of your skin Yellow raised spots on the whites of your eyes Bones and muscles Stiffness in your joints; problems moving or straightening arms, hands, legs, or feet Pain deep in your hip bones or ribs Muscle weakness 15. What should healthcare providers do in response to this new information? Physicians should consider the risks and benefits of using gadolinium-based contrast agents for MRI or MRA in patients with moderate to end-stage kidney disease. If such a patient receives gadolinium-based contrast agent, the physician should consider prompt dialysis. Physicians should also report all cases of NSF/NSD to the FDA’s MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.
16. What additional actions are likely to follow? FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider other risk management options. 17. Where can I find more information about gadolinium-based agents and about NSF/NFD? The package inserts provide more information about all of the approved gadolinium-based agents. More information about NSF/NFD can be found at the following website: http://www.pathmax.com/dermweb/. ” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
For more on gadolinium, contrast agent or NSF, see Gadolinium or NSF at Legal Sleuth® or Gadolinium, Contrast agent or NSF at Gooch Law Firm
- Public Health Advisory - Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI) (FDA) FDAAn excerpt from the article states that "The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). An MRA test uses magnetic resonance imaging to take pictures of blood vessels. During an MRA test, a drug known as a gadolinium-contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues. The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan®, a gadolinium-containing contrast agent, and took the MRA test. The FDA is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD. While FDA conducts its investigation, the following recommendations are being provided to health care providers and patients: Gadolinium-containing contrast agents, especially at high doses, should be used only if clearly necessary in patients with advanced kidney failure (those currently requiring dialysis or with a Glomerular Filtration Rate (GFR) = 15 cc/min or less). It may be prudent to institute prompt dialysis in patients with advanced kidney dysfunction who receive a gadolinium contrast MRA. Although there are no data to determine the utility of dialysis to prevent or treat NSF/NSD in patients with decreased kidney function, average excretory rates of gadolinium are 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Okada, et al, Acta Radiologica, vol 42 p. 339, May 2001). Five gadolinium-containing contrast agents are FDA-approved for use during magnetic resonance imaging (MRI), a test that can look at internal body organs and tissues. The trade names of the U.S. approved gadolinium-containing contrast agents are: Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. None of these drugs are FDA approved for MRA. The dose of gadolinium-containing contrast agent given to patients undergoing an MRA test is often higher (up to three times) than the approved dose for MRI. NSF/NFD appears to occur in patients with kidney failure along with high levels of acid in body fluids a condition known as acidosis that is common in patients with kidney failure. Patients with NSF/NFD have tight and rigid skin making it difficult to bend joints. NSF/NFD may also result in fibrosis, or scarring, of body organs resulting in the inability of body organs to work properly and can lead to death. Diagnosis of NSF/NFD is done by looking at a sample of skin under a microscope. Scientists first identified NSF/NFD in 1997 and the cause of NSF/NFD is unknown. Worldwide, there are approximately 200 reports of NSF/NFD. The 25 cases of NSF/NFD were reported on May 29, 2006, by the Danish Medicines Agency. Among these, 20 cases occurred in Denmark and five cases occurred in Austria. The patients developed NSF/SFD within 3 months (range 2 weeks to 3 months) after receiving the gadolinium-containing contrast agent. The five patients from Austria are described in a publication: Grobner T. Gadolinium – a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis Nephrol dial Transplant. 21(4):1104-8. The FDA has not yet determined whether exposure by patients with kidney failure to gadolinium-containing contrast agents during an MRA test causes NSF/NFD. The FDA is gathering additional information about NSF/NFD and investigating whether other patients who received gadolinium-containing contrast agents developed NSF/NFD.” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
For more on gadolinium, contrast agent or NSF, see Gadolinium or NSF at Legal Sleuth® or Gadolinium, Contrast agent or NSF at Gooch Law Firm
- Public Health Advisory: Update on Magnetic Resonance Imaging (MRI) Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy (FDA) FDAAn excerpt from the article states that "12/22/2006 Updated 5/23/2007 The FDA has received additional information about a new disease, known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD), which may occur in patients with moderate to end-stage kidney disease after they have had a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) scan with a gadolinium-based contrast agent. An MRI scan provides clear and detailed pictures of internal organs. An MRA test uses a gadolinium-based contrast agent to take detailed pictures of blood vessels. During some MRI scans and all MRA scans, a gadolinium-based contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues. As of December 21, 2006, FDA has received reports of 90 patients with moderate to end-stage kidney disease who developed NSF/NFD after they had an MRI or MRA with a gadolinium-based contrast agent. Their NSF/NFD began from 2 days to 18 months after exposure to the contrast agent. Many, but not all of these patients, received a high dose of the contrast agent; some received only one dose. In light of these reports, FDA is notifying health care providers and patients of the following: Patients with moderate to end-stage kidney disease who receive an MRI or MRA with a gadolinium-based contrast agent may get NSF/NFD which is debilitating and may cause death. Patients who believe they may have NSF/NFD should contact their doctor. Patients who develop NSF/NFD have areas of tight, rigid skin and may have scarring of their body organs. The signs of NSF/NFD also include: burning, itching, swelling, hardening and tightening of the skin; red or dark patches on the skin; yellow spots on the whites of the eyes; stiffness in joints with trouble moving or straightening the arms, hands, legs, or feet; pain deep in the hip bones or ribs; and muscle weakness. When a patient with moderate to end-stage kidney disease needs an imaging study, select imaging methods other than MRI or MRA with a gadolinium-based contrast agent for the study whenever possible. If these patients must receive a gadolinium-based contrast agent, prompt dialysis following the MRI or MRA should be considered. The FDA asks health care professionals and patients to report possible cases of NSF/NFD to the FDA through the MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page. Worldwide, about 215 patients with NSF/NFD have been reported. Of these reports, the medical histories of 75 of these patients were reviewed in detail, and all of the patients had received a gadolinium-based contrast agent for an MRI or MRA. Researchers have identified gadolinium in skin biopsies of patients with NSF/NFD. Why NSF/NFD occurs in patients with moderate to end-stage kidney disease who receive gadolinium-based contrast agent is not yet known. The FDA is working with expert scientists to gather additional information about NSF/NFD. Currently there are five FDA approved gadolinium-based contrast agents, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. These contrast agents are FDA approved for use during an MRI scan, but not for use during an MRA scan. Although NSF/NFD has been reported for only 3 of the 5 gadolinium-based contrast agents, FDA believes that there is a potential for NSF/NFD to occur with the use of any of the approved gadolinium-based contrast agents. You can find more details about NSF/NFD and gadolinium-based contrast agents in FDA’s Information for Healthcare Professionals Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance). ” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
For more on gadolinium, contrast agent or NSF, see Gadolinium or NSF at Legal Sleuth® or Gadolinium, Contrast agent or NSF at Gooch Law Firm
- Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance (FDA) FDAAn excerpt from the article states that "Audience: Radiologists, Nephrologists, Dermatologists and other healthcare professionals
[UPDATED 12/22/2006] FDA notified healthcare professionals that the Agency received a total of 69 case reports of patients with moderate to end-stage renal disease who underwent magnetic resonance imaging or magnetic resonance angiography and developed Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). These reports provide more evidence for a causal relationship between gadolinium-based contrast agents and the development of NSF/NFD.
[Posted 06/08/2006] FDA notified healthcare professionals and consumers that it is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan, a gadolinium-containing contrast agent, and took the MRA test. The FDA is gathering additional information about NSF/NFD and is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD and whether other patients who received gadolinium-containing contrast agents developed NSF/NFD. FDA has not yet determined whether exposure by patients with kidney failure to these products during an MRA test causes NSF/NFD. The FDA urges health care providers and patients to report adverse event information to the FDA online, by phone (1-800-FDA-1088) or by fax (1-800-FDA-0178).
[December 22, 2006 - Drug Information Page - FDA] [June 08, 2006 - Public Health Advisory - FDA] [June 06, 2006 - Dear Healthcare Professional letter - GE Healthcare]” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
For more on gadolinium, contrast agent or NSF, see Gadolinium or NSF at Legal Sleuth® or Gadolinium, Contrast agent or NSF at Gooch Law Firm
- Weed killer atrazine may be linked to birth defect (Reuters) http://bit.ly/dzZMRnAn excerpt from the article states that "Living near farms that use the weed killer atrazine may up the risk of a rare birth defect, according to a study presented this past Friday at the annual meeting of the Society for Maternal-Fetal Medicine in Chicago. About 1 in 5000 babies born in the U.S. each year suffers from gastroschisis, in which part of the intestines bulges through a separation in the belly, according to the March of Dimes. The rate of gastroschisis has risen 2- to 4-fold over the last three decades, according to Dr. Sarah Waller, of the University of Washington, Seattle, and colleagues. Waller's team studied the potential link between the weed killer and the birth defect because, as they note in their conference abstract, "during the last 10 years, the highest percentage per population of gastroschisis was in Yakima County, in the eastern part of the state, where agriculture is the primary industry." Overall, Washington state has about double the national average of gastroschisis cases - an average of 43 cases per year, Waller told Reuters Health.
The researchers looked at more than 4,400 birth certificates from 1987-2006 - including more than 800 cases of gastroschisis -- and U.S. Geological Survey databases of agricultural spraying between 2001 and 2006.” ....
keywords: birth defect, birth injury - For more on birth defects or birth injuries, see Birth-Injury at Legal Sleuth® or Birth-Injury at GLF
- Migraine drugs don't up birth defect risk: study (Reuters) http://bit.ly/9EuJP4An excerpt from the article states that "A study in nearly 70,000 pregnant women has found no link between migraine drugs called triptans and the risk of birth defects. However, the researchers did find a "slight increase" in the risk of excessive bleeding during labor, and the failure of the uterus to contract normally after delivery, for women who used the drugs while pregnant. Triptans are among the most powerful drugs used for migraine; others include aspirin, Excedrin, and ibuprofen. While as many as three in 10 women may develop migraines during their childbearing years, women often shy away from using such drugs during pregnancy because of safety concerns, according to study co-author Katerina Nezvalova-Henriksen of the University of Oslo in Norway and her colleagues. However, the authors of the study in Headache note, untreated migraine may itself carry risks for mother and child; some studies have linked it to pre-eclampsia, a potentially deadly pregnancy complication. "While it is important to exert caution when using any medications during pregnancy, this study indicates" that pregnant women can either start or continue taking triptans without "any major risk" of miscarriage, premature delivery, or other bad outcomes, the authors conclude. Nezvalova-Henriksen and her team studied nearly 70,000 women. Two percent, or 1,535, had used sumatriptan (Imitrex), rizatriptan (Maxalt), zolmitriptan (Zomig), or eletriptan (Relpax) in pregnancy.” ....
keywords: birth defect, birth injury - For more on birth defects or birth injuries, see Birth-Injury at Legal Sleuth® or Birth-Injury at GLF
- Hydroxycut linked to other cases of liver damage (Reuters) http://bit.ly/9TGbBQAn excerpt from the article states that "A new study strengthens evidence that the once widely advertised weight-loss supplement Hydroxycut caused serious liver damage in some users. Last May, 14 Hydroxycut products were recalled by the manufacturer, Canada-based Iovate Health Sciences, after the U.S. Food and Drug Administration (FDA) issued a warning to all consumers to stop using the supplements. The warning was based on 23 reports to the agency describing liver damage in Hydroxycut users -- ranging from inflammation to tissue death severe enough to require a liver transplant. The supplement was also linked to one death. Iovate said in May that it was recalling Hydroxycut because they "became aware that the U.S. Food and Drug Administration's assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate's analysis." They noted that "the number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years." In the new study, reported in the American Journal of Gastroenterology, researchers analyzed 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study. Looking at factors like patients' risk factors for liver disease and the timing of their Hydroxycut use, the researchers found that for eight of the liver-damage cases, there was a greater than 95 percent likelihood that the weight-loss aid was to blame. In five cases, the researchers concluded that Hydroxycut was "highly likely" the cause (a 75 to 95 percent chance), while it was probably to blame in two cases (a 50 to 74 percent chance). The last two cases were considered to be possibly linked to Hydroxycut use. This type of study cannot definitively prove cause-and-effect -- something that is often "challenging" to do in cases where a drug is suspected of causing a toxic effect, noted study co-author Dr. Tse-Ling Fong, an associate professor of medicine at the University of Southern California, Los Angeles. This is particularly true of dietary supplements, Fong told Reuters Health, because they do not have to be tested in clinical trials before going on the market, and little may be known about their potential for side effects.” ....
keywords: hydroxycut, diet drug, liver damage, product liability - For more on hydroxycut, see Hydroxycut at Legal Sleuth® or Hydroxycut at GLF
- Indian CEO: ‘U.S. Would Grant a Patent to a Piece of Toilet Paper’ (WSJ) http://bit.ly/dxLHHEAn excerpt from the article states that "India has become a hot market for multinational drug companies since it revised its patent laws to give more protection to brand-name medicine. But to hear the branded makers tell it, the patent welcome mat has some holes in it, a WSJ report recounts this morning. The drug makers point to three top-selling medicines that have failed in their efforts to win protection either through India’s patent office or the country’s court system. ” .... keywords: intellectual property, patent, patent infringement
- Bursting Pipes Lead to a Legal Battle (NY Times) http://nyti.ms/9XpUmh An excerpt from the article states that "State and local governments across the country may have to replace their water systems because of defective pipes, according to a whistle-blower lawsuit unsealed this week.John Hendrix of Clifton, N.J., says faulty pipes made by his former employer, JM Eagle, have been installed in places like Nevada, where breaks have occurred.The whistle-blower, John Hendrix, accuses his former employer, one of the world’s largest pipe manufacturers, of falsifying test results about the quality of its products. Pipes that should last 50 years are in some cases rupturing in their very first year, according to Mr. Hendrix and some state documents. This can lead to explosions, leaks, fires and other dangers. Officials of the company, JM Eagle, dispute the allegations and say that the tests were done correctly. Mr. Hendrix said he uncovered the problem after he was asked to oversee the certification of a new manufacturing process that put the pipes through a prescribed battery of tests. He concluded that JM Eagle had been selling substandard plastic pipe since 1996, and that it had subsequently manipulated test results. When he told his superiors of his concerns, they said the problems were a normal “business risk,” according to the complaint. When he pressed harder, he was fired. Mr. Hendrix, 31, of Clifton, N.J., then began a whistle-blower lawsuit under federal and state statutes that allow private citizens to file on behalf of government agencies if they suspect a fraud. In his lawsuit, he asserts that less than half of JM Eagle’s pipe would have qualified for sale if it had been properly tested. “It became apparent to me that this was being done intentionally,” he said in an interview.” .... keywords: qui tam, whistleblower, federal false claims
- Stents open clogged arteries(CNN) http://bit.ly/9UmVVTAn excerpt from the article states that "Stents, small metal scaffolding devices placed inside blood vessels around the heart, are used to treat conditions that result when arteries become narrow or blocked. Former President Clinton underwent a procedure to place two stents in one of his coronary arteries Thursday after experiencing chest "discomfort," his foundation said. A stent is very effective at reducing chest pain and treating a heart attack, said Dr. Clyde Yancy, president of the American Heart Association.In 2004, Clinton underwent a quadruple bypass operation to free four blocked arteries. For someone who has a history of heart problems, heart attack is the first concern, Yancy said.” .... keywords: stent, drug eluting stent, medicated stent, heart stent
- Stents Are Increasingly Common but Not Without Risk (WSJ) http://bit.ly/9i64XSAn excerpt from the article states that "Stents, the tiny metal tubes used to relieve former President Bill Clinton's heart problem on Thursday, are one of medicine's most common devices and are implanted in about one million Americans annually. The devices are deployed during angioplasty procedures, which are used to clear obstructed arteries in the heart. A catheter inserted into an artery in the patient's groin is used to thread a balloon through the body to a blockage, in this case one of Mr. Clinton's coronary arteries. After the balloon is inflated to clear the obstruction, the stent—which resembles a tiny mesh scaffold—is then put in place to prop open the diseased artery.Video Animation: How Stents Work Since the first coronary stent was introduced by Johnson & Johnson in 1994, the technology has transformed treatment for coronary arteries, enabling millions of patients to avoid or delay undergoing bypass surgery. But their arrival has also sparked a controversy over whether cardiologists use them too soon or too often. "Stents really represent the most contemporary care for patients" with the symptoms Mr. Clinton is reported to have experienced on Thursday, said Clyde Yancy, president of the American Heart Association and a cardiologist at Baylor University Medical Center in Dallas. The most commonly used models are coated with a drug that is intended to prevent scar tissue from building up in and around the device.That complication typically has occurred within six months or so in about 30% or more of patients who got bare-metal stents. The drug-coated versions, marketed mainly by Abbott Laboratories, Boston Scientific Corp., and Medtronic Inc., as well as Johnson & Johnson, sharply reduce the likelihood of reclogging and the need for a repeat procedure.” .... keywords: stent, drug eluting stent, medicated stent, heart stent
- Honda expands airbag recall as more Toyotas probed (Reuters) http://bit.ly/afm7wyAn excerpt from the article states that "Honda Motor Co said it would recall another 440,000 cars around the world for faulty airbags as rival Toyota Motor Corp faced further probes over its largest-ever safety crisis. Honda, Japan's No. 2 automaker, has now recalled close to 950,000 vehicles for airbag problems linked to one fatality and a total of 11 injuries in the United States. While auto recalls are not uncommon and Honda's is not huge, it comes at a sensitive time for an industry struggling to draw customers back to showrooms after a brutal downturn. Toyota President Akio Toyoda will come to the United States in early March to meet government officials and to visit the carmaker's local operations, delaying a trip initially scheduled for next week due to the heavy snowfall in Washington, the Nikkei newspaper reported. A Republican lawmaker, U.S. Rep. Darrell Issa, has invited Toyoda to meet with members of Congress the week of February 22. He is also urging the House Oversight Committee chairman to invite Toyoda to a February 24 hearing. A Toyota representative could not immediately be reached for comment. Toyoda's U.S. visit comes as the world's biggest automaker faces a storm of criticism over safety issues and perceptions that the carmaker has been too slow to respond. Toyota has up to 70,000 vehicles still stranded on U.S. dealer lots due to defective accelerator pedals that are the subject of a major safety recall, a top U.S. Toyota executive said on Wednesday. Bob Carter, Toyota's U.S. sales chief, said all Toyota U.S. dealers have parts to repair the accelerator pedals and that the dealers were focused on fixing customers' cars before tackling the vehicles in the inventory. Toyota U.S. dealers are repairing more than 52,000 gas pedals per day and have completed work on about 225,000 since they started late last week, Carter said. ” .... keywords: recall, defective product, product liability, personal injury
- BP To Restart Hydrotreater At Texas Refinery - Filing (Fox) http://bit.ly/bNebKd keywords: chemical plant, petrochemical
- Defibrillator Safety Questioned
(WSJ)http://bit.ly/dhfjSG
An excerpt from the article states that "Two defibrillator brands made by Boston Scientific Corp. have a design flaw that can result in the devices delivering potentially life-threatening shocks to the hearts of patients, authors of a medical journal article say. The defect can cause the Cognis and Teligen brand defibrillators to deliver the shocks when they aren't needed in the many patients who get the devices implanted just under the skin, according to an article in the journal HeartRhythm. The potential malfunction, while appearing to be extremely rare, could in theory affect any of the more than 90,000 devices implanted, said the authors. They advised physicians to look for the problem should the devices malfunction. Defibrillators deliver shocks or electronic pulses to hearts with abnormal rhythms so they beat normally. The devices have saved thousands of lives since patients in the U.S. who had suffered a cardiac arrest started getting them in the mid-1980s. Boston Scientific had warned in December that there was a problem with shocks with the defibrillators—the third of various types the company has disclosed with its Cognis and Teligen devices. But it said the problem was limited to the few patients who had the devices implanted deeper in their bodies, under their chest muscles. The Natick, Mass., medical device maker criticized HeartRhythm for publishing the article without a "detailed engineering analysis" of the highlighted device, and said the company's testing showed the problem didn't cause the defibrillator to deliver inappropriate shocks. Boston Scientific said the performance of the Cognis and Teligen lines "compares very favorably to the performance of similar devices and is well within accepted performance ranges." A spokeswoman for HeartRhythm said the journal had not seen the Boston Scientific statement and didn't have any immediate comment.” .... keywords: defibrillator
- Merck Settles Some Vioxx Suits (WSJ) http://bit.ly/b2AFlG keywords: vioxx lawsuit
- In a California Town, Birth Defects, Deaths and Questions (NY Times) http://nyti.ms/9Z7i1tAn excerpt from the article states that "KETTLEMAN CITY, Calif. — State and federal officials are scrambling to determine what caused the deaths of three children in this Central California farming town, which shares a ZIP code with the largest hazardous waste treatment site west of the Mississippi. The California Aqueduct borders the town. Over a 15-month period in 2007 and 2008, six children of mothers from Kettleman City were born with serious birth defects, including cleft palates, deformities and brain damage. Half of those infants subsequently died. And while health authorities have not placed any blame, the apparent cluster of defects has given new ammunition to environmentalists and local residents who have long been wary of the town’s proximity to the Kettleman Hills waste facility, a 1,600-acre landfill that lies in an unincorporated area less than four miles west of here. “We’ve always been saying, ‘The sky is falling, the sky is falling,’ ” said Maricela Mares-Alatorre, a Kettleman City resident and longtime critic of the facility. “Well, for those mothers, the sky fell.” Last week, officials from the Environmental Protection Agency toured the landfill and visited with families of the children with birth defects. That action came less than a week after Gov. Arnold Schwarzenegger ordered the State Department of Public Health and California’s Environmental Protection Agency to look into what he called “an abnormal percentage of birth defects” occurring here. On Tuesday, the first report from the state is expected to be delivered to the Kings County Board of Supervisors, which recently approved an expansion of the waste facility, owned by Waste Management, the largest recycler and waste-handling company in North America. The company operates hundreds of other landfills nationwide. The company says it welcomes the investigation and the visit from the E.P.A.’s regional administrator, Jared Blumenfeld. “We were proud to showcase our sophisticated, state-of-the-art facility,” said Bob Henry, the senior district manager of the Kettleman Hills facility in a statement, “and provide him an opportunity to see, firsthand, why we set the standard for safely managing hazardous waste.” .... keywords: birth defect, birth injury, personal injury
- FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab)(FDA) http://bit.ly/d4tSC3An excerpt from the article states that "[02-05-2010] The U.S. Food and Drug Administration (FDA) is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide (see Data Summary for additional information). Tysabri was approved by the FDA in November 2004 for the treatment of relapsing forms of multiple sclerosis (MS). Tysabri is also approved by FDA for treating moderately to severely active Crohn's disease. Since 2006, Tysabri has only been available through a risk minimization plan called Tysabri Outreach Unified Commitment to Health (the TOUCH™ Prescribing Program). The program, developed by the FDA and the manufacturer of Tysabri, Biogen-Idec, is intended to make sure that healthcare professionals and patients understand the benefits and potential risks associated with the use of Tysabri, including the risk of PML.Under the TOUCH™ program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections. For additional information about the TOUCH™ program click here. Based on the available information, the FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases. Additional Information for Patients * Tysabri is a medication that has been associated with PML and the risk of developing this disease increases with the number of Tysabri infusions received. * PML is a rare infection of the brain caused by the JC virus, which is a common virus often acquired during childhood. Most adults have been infected with JC virus, but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) causes it to be reactivated. Once reactivated, the virus may infect the brain and cause PML. * People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants) are most likely to get PML. Tysabri is an immunosuppressant medication. * The symptoms of PML may begin gradually, usually worsen rapidly, and vary depending on which part of the brain is infected. These symptoms may include difficulty with walking and other movements, decline in mental function, and problems with vision and speaking. Rarely, headaches and seizures occur. Symptoms of PML may be similar to multiple sclerosis (MS).
* If PML is suspected, Tysabri treatment should be stopped and not resumed until further clinical evaluation is performed. * When patients have the clinical symptoms of PML, a PML diagnosis is made by an MRI of the brain and confirmation of the presence of JC virus in the cerebrospinal fluid.
* Cases of Immune Reconstitution Inflammatory Syndrome (IRIS) have been reported after stopping Tysabri because of PML. IRIS is a condition that can occur after discontinuing immunosuppressant medications. During immune system recovery, patients can experience a severe inflammatory response to an infection and their symptoms can get worse, sometimes after a period of improvement. Additional Information for Healthcare Professionals
* An update to the Warnings and Precautions section of the drug label has been added to inform healthcare professionals that the risk of PML increases with the number of Tysabri infusions received o There have been no reports of PML in patients treated for less than 12 months since Tysabri's remarketing.In patients treated with 24 to 36 infusions, the overall worldwide rate and the rate in the U.S. of developing PML is similar to the rate seen during clinical trials (1 case per 1,000 patients treated). Outside of the U.S., the rate is approximately 2 cases per 1,000 patients.The reasons for this difference are unknown. There is limited clinical experience beyond 36 Tysabri infusions either in clinical trials or in the postmarketing setting.
o PML is diagnosed on the basis of clinical symptoms, MRI findings, and the detection of JC virus in the cerebrospinal fluid. o Tysabri should be withheld at the first sign or symptom suggestive of PML. o Continued clinical vigilance and close monitoring for the signs and symptoms of PML as dictated by the TOUCH™ Prescribing Program is necessary. * An update to the Warnings and Precautions section of the drug label has been added to inform healthcare professionals about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who developed PML and subsequently discontinued Tysabri. o IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient's condition after return of immune function. o IRIS has been reported in patients who discontinue Tysabri as a result of developing PML, but not in patients who discontinue Tysabri for other reasons. o Many patients who stopped Tysabri due to PML and who received either plasma exchange or immunoadsorption (measures taken to decrease circulating Tysabri levels) developed IRIS days to several weeks after these treatments. o Healthcare professionals should monitor their patients for the development of IRIS and appropriate treatment of the associated inflammation after stopping Tysabri should be undertaken.The FDA continues to receive reports of PML in patients receiving Tysabri in the United States and overseas. Tysabri, an immunosuppressant medication, was first approved by the FDA in November 2004 for the treatment of relapsing forms of multiple sclerosis (MS). In February 2005, the marketing of Tysabri was suspended by the manufacturer after three patients in clinical trials (two patients in MS trials and one in a Crohn's disease [CD] trial) developed PML. In June 2006, the FDA approved an application for the re-marketing of Tysabri as monotherapy for the treatment of patients with relapsing forms of MS.Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy. In January 2008, Tysabri was also approved for inducing and maintaining a clinical response and remission in patients with moderately to severely active CD who have had an inadequate response to, or are unable to tolerate, conventional CD therapies.
Since July 2006 (when marketing resumed) through January 21, 2010, there have been 31 confirmed cases of PML worldwide in patients using Tysabri. Of these 31 case reports, 10 were from patients in the U.S. As of January 21, 2010, eight patients have died. In all cases, patients were receiving Tysabri as monotherapy for the treatment of MS. There have been no postmarketing reports of PML in patients treated with Tysabri for CD. In the U.S., less than 2% of Tysabri use is in patients with CD. Tysabri is not approved for CD outside of the U.S. The risk of developing PML increases with the number of Tysabri infusions received. Tysabri is administered as a single intravenous infusion every four weeks. The overall worldwide cumulative rate of PML in patients who have received one or more Tysabri infusions is 0.5 cases of PML per 1,000 patients. Since Tysabri's re-marketing in the U.S., there have been no cases of PML in patients treated with Tysabri for less than 12 months. The overall worldwide cumulative rate of PML in patients who have received at least 24 infusions is 1.3 cases of PML per 1,000 patients. In the U.S., the cumulative rate of PML in patients who have received at least 24 infusions is 0.8 per 1,000 patients. Outside of the U.S., the cumulative rate of PML in patients who have received at least 24 infusions is 1.9 per 1,000 patients. Approximately 66,000 people, worldwide, have received at least one dose of Tysabri since marketing resumption (through December 31, 2009). Relatively few patients have received 36 infusions or more, either in clinical trials or since marketing resumption; therefore, the magnitude of the risk of PML and other adverse events in patients who have received 36 infusions or more is not able to be well characterized. The following table summarizes cumulative rates of PML according to geographic location and number of Tysabri infusions received since Tysabri re-marketing: Number of Tysabri infusions received Overall cumulative rate of PML per 1,000 patients Cumulative rate of PML per 1,000 patients outside of U.S. Cumulative rate of PML per 1,000 patients in U.S.
> 1 0.5 0.7 0.3
> 12 0.8 1.1 0.5
> 24 1.3 1.9 0.8
> 30 1.0 1.8 0.5
The FDA and its international counterparts remain committed to tracking and monitoring for any change in the risk of PML associated with the use of Tysabri.This communication is intended to increase awareness about the risk of PML in patients treated with Tysabri.At this time, the FDA believes that the clinical benefits of Tysabri outweigh its risks. Tysabri will remain available to patients through the TOUCH™ Prescribing Program. Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections. ".... keywords: progressive multifocal leukoencephalopathy (PML) [
- Boston Scientific to Pay J&J $1.73B to Settle Stent Patent Disputes (WSJ) http://bit.ly/axWPkC keywords: patent, patent infringement, patent litigation, drug eluting stent, personal injury
- Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure (Heart Rhythm) http://www.heartrhythmjournal.com/article/S1547-5271%2809%2900175-1/abstract (Heart Rhythm) keywords: sprint fidelis, sprint fidelis lead wire, lead wire fracture, medtronic sprint fidelis lead wire, lead failure, lead wire failure
- Hospitals Dispute Medtronic Data on Wires (WSJ) http://bit.ly/a8RDueAn excerpt from the article states that "Some leading hospitals are reporting failure rates for Medtronic Inc.'s fracture-prone defibrillator wires—including among young people—that are significantly higher than what the company has publicly disclosed. Medtronic, a medical-device maker, pulled the Sprint Fidelis defibrillator wires off the market in 2007 and substituted another type of wire with a lower failure rate. But an estimated 150,000 Sprint Fidelis wires, which are known as leads, remain implanted in U.S. patients. The company, and most doctors, generally advise patients not to have the leads surgically removed if they haven't fractured, because of the risk of complications. Medtronic says its own research shows the Sprint Fidelis leads survive for three years at least 95.4% of the time, for a failure rate of 4.6%. Reports from hospitals including the University of Rochester in New York state, the Minneapolis Heart Institute, the Mayo Clinic and the University of Ottawa, say the overall failure rate for Sprint Fidelis leads is as much as two times as great as the company's own data indicate. Some of the hospitals also report that the rate of fracture accelerates as the leads age. ".... keywords: sprint fidelis, sprint fidelis lead wire, lead wire fracture, medtronic sprint fidelis lead wire, lead failure, lead wire failure
- Birth defect total in California town now at 6 (AP) http://bit.ly/cxDWec (AP) keywords: birth defect, birth injury, personal injury
- [Levofloxacin-induced bilateral rupture of the Achilles tendon: clinical and sonographic findings] http://bit.ly/bI8Js2 (PubMed) An excerpt from the article states that "The fluoroquinolones are antibiotics widely used in the clinical practice. The concomitant use of corticosteroids and fluoroquinolones in elderly patients is recognised as a risk factor for developing clinically relevant tendon lesions. Fluoroquinolone-induced tendinopathy is underreported in the literature. A 67-year-old man, came to our observation complaining of 5 days history of bilateral heel pain. The patient had a medical history of sarcoidosis and was treated with a daily dose of 5 mg of prednisone. He was initially given oral levofloxacin (500 mg/die) for 10 days, because of an acute respiratory infection. Two days before the end of the antibiotic therapy, he developed bilateral heel pain. He denied any history of trauma. Physical examination revealed swelling and marked tenderness with mild palpation of the Achilles tendons at the calcaneal insertion. The ultrasound evaluation of the Achilles tendons revealed the following main abnormalities: diffuse thickening, loss of the "fibrillar" echotexture, blurred margins, and bilateral partial tendon tears. Bilateral Achilles tendon pain and rupture has been described as a rare adverse effect of fluoroquinolone treatment. Most of the fluoroquinolone-induced tendinopathies of the Achilles tendon are due to ciprofloxacin. To the best of our knowledge, this is the first description of bilateral Achilles tendon rupture due to levofloxacin. The risk/benefit ratio of the fluoroquinolones should be carefully considered and these drugs should be prescribed cautiously in elderly patients treated with corticosteroids. This case can be regarded as a representative example of the potential clinical efficacy of sonography in daily rheumatological practise."... keywords: levaquin, product liability, pharmaceutical liability, tendon rupture, Achilles tendon, tendinitis, personal injury
- Lawsuit: Dentist's Drill Left in Woman's Head http://bit.ly/9nO7QO (Fox) keywords: personal injury
- Studies Link Rare Ailment to Pain Pumps http://bit.ly/adFafM (NY Times) - An excerpt from the article states that "When the first cases popped up in orthopedic journals, they read like medical mysteries. Surgeons around the country reported that several active young patients had suddenly developed chondrolysis, a relatively rare ailment in which joint cartilage dies, leaving bone to grind on bone. Marcus Suhn's football career ended when the cartilage in his shoulder deteriorated. His shoulder joint was replaced. Whitney Moore developed chondrolysis after surgery for a shoulder injury. Chondrolysis has ended the athletic careers of dozens of high school and college students. In the most severe cases, it has required joint replacements. Many sufferers face lifetimes of pain and disability. “I’ve lost so many hours of sleep over this, I can’t tell you,” said Dr. David S. Bailie, an orthopedic surgeon in Scottsdale, Ariz., who said he had seen dozens of cases of chondrolysis since 2005. “There’s nothing worse than a surgeon doing something that causes a problem, not fixes a problem.” Although it is still unknown why chondrolysis develops, several medical studies have concluded that a likely culprit is a pain pump, a postsurgical medical device used to deliver local anesthetics to a specific area through a plastic tube. Whether the pumps caused the chondrolysis — and whether manufacturers should have done more to warn surgeons about the potential risks — is the subject of more than 150 lawsuits working their way through state and federal courts. Last Friday, an Oregon jury awarded nearly $5.5 million to a chondrolysis patient, and at least a dozen cases are expected to go to trial this year. Lawyers for the patients argue that the manufacturers disregarded safety in their quest to expand into the orthopedic market. But the manufacturers and some medical experts argue that more research is needed to determine whether pain pumps are to blame. Pain pumps became popular with orthopedic surgeons in the late 1990s because they were seen as an alternative to extended hospital stays and safer than prescribing narcotic painkillers. But the Food and Drug Administration never cleared the pumps for use in joints, and many in the medical profession now say that by exposing cartilage to local anesthetics for up to 72 hours, the devices turned otherwise harmless medications into toxins. In November, the F.D.A. issued a warning about using pain pumps in joints and ordered manufacturers of local anesthetics and pumps to change labels to discourage doctors from such uses.".... keywords: shoulder pain pump, chondrolysis, PAGCL, product liability
- Opiate painkillers raise fracture risk http://bit.ly/dmHO5s (Reuters) - An excerpt from the article states that "Older adults who take powerful prescription painkillers known as opioids face an increased risk of bone fractures, especially at moderately high medication doses, a new study finds.Opioids are powerful narcotic pain medications that include morphine, oxycodone (Oxycontin and other brands) and hydrocodone (Vicodin and others). The drugs work well against severe pain in the short term, but their longer-term effectiveness for chronic pain is less clear. Moreover, with longer use comes the risk of addiction, in addition to side effects such as nausea, constipation, dizziness and sedation. That dizziness and sedation can also set opioid users up for falls, which, in older people especially, may result in serious fractures. The new study, published in the Journal of General Internal Medicine, confirms the risk of fracture associated with opioids, and also shows that moderately higher drug doses further the hazard. Researchers found that among more than 2,300 older adults with chronic pain, the risk of suffering a bone fracture was higher when patients were using an opioid for a prolonged period than when they were opioid- free.".... keywords: personal injury
- America's Least Deadly Hospitals http://bit.ly/4R4scT (Forbes) - An excerpt from the article states that "When contemplating major surgery, many people go to whatever hospital their family doctor recommends. Others chose a hospital for its star surgeon or because they've seen billboard ads touting its specialties. Either way, it can be a fatal mistake. Every year 100,000 people die in hospitals because of preventable complications or hospital-acquired infections. Many more suffer serious harm as a result of well-intended treatments gone awry.".... keywords: medical malpractice, personal injury
- FDA Announces Class I Recall of Certain Infusion Set Needles http://bit.ly/60ukSt (FDA) - An excerpt from the article states that "FDA NEWS RELEASE For Immediate Release: Jan. 26, 2010 Media Inquiries: Peper Long, 301-796-4671, mailto:mary.long@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA Announces Class I Recall of Certain Infusion Set Needles Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted. Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate. There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the following product codes or catalog numbers: ..... Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation. Direct all questions concerning this recall to:".... keywords: fda, recall, personal injury
- New rule for truck, bus drivers: No texting http://bit.ly/bVw5w0 (CNN) - An excerpt from the article states that "Drivers of commercial trucks and buses are prohibited from texting under federal guidelines that U.S. Transportation Secretary Ray LaHood announced Tuesday. "We want the drivers of big rigs and buses and those who share the roads with them to be safe," LaHood said in a statement. "This is an important safety step, and we will be taking more to eliminate the threat of distracted driving." The prohibition is effective immediately. Truck and bus drivers who text while driving commercial vehicles may be subject to civil or criminal penalties of up to $2,750, the Department of Transportation said in a news release. The release did not offer specifics on how the prohibition will be enforced. One of the nation's largest groups representing professional truck drivers -- the Owner-Operator Independent Drivers Association -- expressed support for the goal but dismay at its implementation.
"We support where they are going, but not how they got there," said Todd Spencer, the group's executive vice president. "Making their action effective immediately bypasses normal regulatory rulemaking processes. Those processes allow actions to be vetted for unintended consequences as well as potential implementation and enforcement problems. "We very much share in their goal, but their legal justification for taking immediate action raises many concerns." Cracking down on distracted drivers has been a focus of LaHood's since he took office last year. In September, he convened a two-day summit on the issue in Washington. The Transportation Department recently launched the Web site distraction.gov to raise awareness of the dangers of distracted driving. And this month, LaHood and National Safety Council President Janet Froetscher announced the creation of the advocacy group FocusDriven, a nonprofit that supports the families of distracted driving victims, modeled after Mothers Against Drunk Driving.]".... keywords: truck accident, 18 wheeler accident, semi-truck accident, personal injury
- Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review http://bit.ly/6wd0Ch (FDA) - An excerpt from the article states that "Cardiology and endocrinology healthcare professionals
[Posted 01/21/2010] FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:
History of coronary artery disease (e.g., heart attack, angina) History of stroke or transient ischemic attack (TIA)
History of heart arrhythmias, History of congestive heart failure, History of peripheral arterial disease, Uncontrolled hypertension (e.g., > 145/90 mmHg). Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.
[01/21/2010 - Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia - FDA] Previous MedWatch Alert: [11/20/2009 - Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review]".... keywords: diet drug,Fen Phen, PPH, primary pulmonary hypertension, recall, product liability, personal injury
- Fingertip Amputations Prompt Recall of Graco Strollers http://bit.ly/6MUNn0 (NY Times) - An excerpt from the article states that "About 1.5 million Graco strollers sold at Wal-Mart, Target and other major retailers are being recalled after some children’s fingertips were amputated by hinges on the products. The recall by Graco Children’s Products includes certain model numbers of its Passage, Alano and Spree Strollers and Travel Systems. The company, based in Exton, Pa., received seven reports of injury to children who had placed their fingers in a stroller’s canopy hinge as the canopy was being opened or closed. Five children suffered severed fingertips, and two children received cuts on their fingertips. The strollers were made in China by Graco and sold at AAFES, Burlington Coat Factory, Babies “R” Us, Toys “R” Us, Kmart, Fred Meyer, Meijer, Navy Exchange, Sears, Target, Wal-Mart and other retailers from October 2004 to December 2009. In announcing the recall Wednesday, the Consumer Product Safety Commission said the strollers posed an amputation and laceration hazard to children when the canopy was opened or closed. The government advised consumers to stop using the strollers and contact Graco to receive a free repair kit. The recall involves strollers made between October 2004 and February 2008. The model numbers and manufacture dates are on the lower inside portion of the rear frame, just above the rear wheels.".... keywords: recall, product liability, defective part, personal injury
- Living With a Formerly Fatal Blood Cancer http://bit.ly/6lBzzY (NY Times) - An excerpt from the article states that "In December 2005, a series of mysterious symptoms — night sweats, easy bruising, swollen ankles and breathlessness upon exertion — prompted Barry to see his doctor. Only six months earlier, a physical exam had found nothing abnormal. But now Barry’s white blood cell count was through the roof. A bone marrow test the next day revealed a genetic abnormality called the Philadelphia chromosome that is the signature of chronic myelogenous leukemia, or C.M.L., a blood cell cancer that in the last decade has been transformed from ultimately fatal to nearly always treatable, usually until something else claims the patient’s life. Despite his illness, Barry, a lawyer who for privacy reasons asked that his last name not be used, is living a normal life. “I go to the gym, go to work, travel, play with my grandson — that’s the best,” he said in an interview. “In some of my support groups, people have been living with the disease now for 10 or 12 years.” Before 2000, fewer than half of C.M.L. patients survived seven years; now nearly 90 percent are alive seven years after diagnosis and, like Barry, lead relatively normal lives. (The basketball star Kareem Abdul-Jabbar announced in November that he had been living with the disease for nearly a year.) “C.M.L. has become a chronic disease leading to a normal life span in the majority of patients,” Dr. Elias Jabbour of the University of Texas M.D. Anderson Cancer Center said last month in a teleconference workshop sponsored by CancerCare. “As for quality of life, among more than 3,000 patients who have been followed now for almost 10 years, there’s been no significant increase in the incidence of infection, other cancers or other causes of death when compared to the normal population.” What led to this turnaround was identification of the genetic marker of the disease and development of a drug called Gleevec (imatinib), which attacks the leukemia-promoting protein, tyrosine kinase, found in 95 percent of C.M.L. patients. Since the approval in 2001 of Gleevec, a drug that inhibits activity of this protein, two other even more powerful tyrosine kinase inhibitors have been approved by the Food and Drug Administration to treat the disease. Barry, for example, is now on the third generation of anti-C.M.L. drugs, Tasigna (nilotinib), after his cancer became resistant to control by Gleevec and he developed an uncontrollable side effect to its successor, Sprycel (dasatinib). A Model of Complexity But while the success to date with C.M.L. has been nothing short of inspirational, the experience over the past decade with this genetically relatively simple cancer has demonstrated why it is so challenging to find cures for other cancers, most of which are much more complex. As sometimes happens with C.M.L., all it takes for a cancer to escape the stranglehold of modern therapies is for one cancer cell to develop a treatment-resistant mutation and take over. “C.M.L. is a disease we always considered to be a model of genetic abnormality,” Dr. Jorge E. Cortes, a leukemia specialist at M. D. Anderson, said in an interview. “All one needed to do is design a drug directed at that abnormality and get a great response. Then we started to uncover just how heterogeneous this ‘homogeneous’ disease really is. “The expression of certain genes is very different in different patients. While the majority of patients respond well to Gleevec, some don’t, some respond initially and then lose the response, and some develop mutations that may or may not be sensitive to the drugs.” Among patients who develop resistance to the treatments, Dr. Cortes said, “only about half have a mutation that we can detect.” “And in those with a mutation,” he continued, “the presence of mutated cells seems to affect the nonmutated cells and make them more resistant to treatment. Even in a disease that is genetically simple, these leukemic cells don’t just roll over and die, even if attacked by very effective weapons. They find ways to survive.” In the M.D. Anderson publication OncoLog last June, Dr. Cortes said: “We’ve clearly changed the natural history of this disease with imatinib, but it doesn’t work for everybody. We still need to improve therapy, in both newly diagnosed and resistant disease.” Another problem is an inability to know for certain if and when the disease has been cured. For as long as a drug is working, patients must now continue to take it every day to keep the disease suppressed. And the cost is astronomical — $98,000 a year, Barry said. He is now on Medicare, and in just one month he reached the “doughnut hole” in the program’s drug benefit, during which he must pay the full cost of treatment before the insurance resumes. Still, Barry remains very encouraged. As he learned from the latest conference of the American Society of Hematology, “they’re working on vaccines and drug combinations, as well as additional drugs for C.M.L., to address a mutation that current drugs don’t handle.”".... keywords: CML, benzene, toxic exposures, toxic tort, benzene exposure
- 635,000 cribs recalled for risk to infants http://bit.ly/4xuVGU (CNN) - An excerpt from the article states that "About 635,000 cribs sold at major discounters nationwide have been recalled by Dorel Asia SRL for strangulation and suffocation hazards that killed one child and injured 10 others, the government said Thursday. The U.S. Consumer Product Safety Commission said that the hardware holding up the side of the crib can fail, causing the drop side of the crib to detach, which could trap and suffocate a child. About 635,000 Dorel Asia stationary and drop-side cribs are affected by the recall. The drop side is "the side of the crib that caregivers can move up and down to get a child in or out of the crib," said Kim Dulic, a spokeswoman for the CPSC. "When the drop side detaches it creates a space in which an infant or toddler can become entrapped and suffocate or strangle," the organization said in the statement. Infants are also at risk of entrapment and possible strangulation if a slat on the crib is damaged, which can occur when the crib is in use, in storage, during shipping and handling and while putting the crib together or taking it apart. ".... keywords: recall, product liability, defective part
- Chrysler vehicles recalled for possible brake failure http://bit.ly/682nNz (CNN) - An excerpt from the article states that " Chrysler Group is recalling about 24,000 late-model Chrysler, Dodge and Jeep vehicles to fix a defective part that could cause sudden, unexpected brake failure. The recall applies to some 2010 model year Chrysler Sebring and Dodge Avenger sedans, Dodge Nitro and Jeep Liberty SUVs, Jeep Commander and Grand Cherokee SUVs and 2009 and 2010 model year Ram trucks. Some of these vehicles could have an improperly formed brake booster rod retaining clip, and some Ram trucks may have been built without the piece. The part is necessary for consistent and proper functioning of the brakes. Chrysler is not aware of any crashes or injuries related to the problem, according a document Chrysler filed with the National Highway Traffic Safety Administration. A Chrysler representative was not immediately available to provide additional comment on the recall.”.... keywords: recall, product liability, defective part, brake failure, auto accident
- Britain apologizes 50 years after Thalidomide scandal http://bit.ly/7RlFL7 (Reuters) - An excerpt from the article states that "The British government apologized on Thursday to sufferers from the thalidomide scandal, half a century after thousands of babies were born with birth defects after their mothers took the morning sickness pill. "The government wishes to express its sincere regret and deep sympathy for the injury and suffering endured by all those affected when expectant mothers took the drug thalidomide between 1958 and 1961," health minister Mike O'Brien told a hushed parliament. "We acknowledge both the physical hardship and the emotional difficulties that have faced both the children affected and their families as a result of this drug, and the challenges that many continue to endure, often on a daily basis," he said. "I know that a lot of Thalidomiders have waited a long time for this," O'Brien said, using the terms survivors of the drug use to refer to themselves. The thalidomide scandal triggered a worldwide overhaul of drug-testing regimes and boosted the reputation of the U.S. Food and Drug Administration, which proved a lone voice in refusing to approve the drug. Thalidomide was marketed internationally to pregnant women in the late 1950s and early 1960s as a treatment for morning sickness. About 10,000 babies were born around the world with defects caused by the drug, ranging from malformed limbs to no arms or legs..”.... keywords: birth defects, paxil, pphn, persistent pulmonary hypertension of the newborn (PPHN), heart defects, birth injury
- Kodak sues Apple, RIM over digital camera patents http://bit.ly/8fjA9M (AP) - An excerpt from the article states that "Eastman Kodak Co. said Thursday it is suing Apple Inc. and BlackBerry maker Research in Motion Ltd. over technology related to digital cameras in their iPhone and BlackBerry smart phones. Kodak, a maker of digital cameras and other photography products, filed a complaint with the U.S. International Trade Commission, alleging the iPhone, Apple's hottest gadget, and Research in Motion's camera-enabled BlackBerry devices infringe on a Kodak patent covering technology for previewing photos. Kodak is asking the federal agency that oversees trade disputes to bar Apple and RIM from shipping the phones. The agency has the power to order Customs to stop imports of products and parts made with contested technology. Kodak also filed separate lawsuits against Apple in U.S. District Court in Rochester, claiming an infringement of patents related to digital cameras and certain computer processes. It is asking for unspecified monetary damages and a court order to end the disputed practices. Sales of iPhones and BlackBerrys aren't immediately threatened. Patent cases can take months or years to resolve, and agreements over licensing and royalty payments often emerge. But the trade commission is viewed as a fast-track mediator that typically resolves such intellectual-property disputes in 12 to 15 months. RIM and Apple officials declined to comment.”.... keywords: patent, infringement, patent litigation, patent lawsuit, intellectual property lawsuit, patent infringement
- Health care: A 'goldmine' for fraudsters http://bit.ly/5OxJea (CNN) - An excerpt from the article states that "There's a group of people who really love the U.S. health care system -- the fraudsters, scammers and organized criminal gangs who are bilking the system of as much as $100 billion a year. Health care identity theft dominated all other crimes in the sector last year, according to Louis Saccoccio, executive director of the National Health Care Anti-Fraud Association (NHCAA), an advocacy group whose members include insurers, law enforcement and regulatory agencies. The most common method of health care identity fraud occurs when someone with legitimate access, such as a hospital administrator or a doctor's assistant, sells patients' information to organized criminal groups. Increasingly, criminal groups are hacking into digital medical records so that they can steal money from the $450 billion, 44-million-beneficiary Medicare system -- making the government, by far, the "single biggest victim" of health care fraud, according to Rob Montemorra, chief of the FBI's Health Care Fraud Unit. All the stolen information includes medical insurance data and Social Security numbers, explained James Van Dyke, president of Javelin Strategy & Research, a research firm specializing in trends in security and fraud initiatives.”.... keywords: qui tam, federal false claims, fraud, whistleblower
- Woman 'Regrows' Face After Allergic Reaction Causes Skin to Fall Off http://bit.ly/5lWD7z (Fox) - An excerpt from the article states that "Four years ago, Eva Uhlin had a fever so she took acetaminophen. The next day, the then 15-year-old found her body covered in blisters. She was admitted to the burn unit of University Hospital in Linkoping in Sweden, and doctors diagnosed her with toxic epidermal necrolysis. She was given morphine to relieve the pain. But Uhlin's skin started to fall off as doctor's examined her. Uhlin lost much of her face's surface over the next few years, as well as skin from various parts of her body and her fingernails.”.... keywords: stevens-johnson syndrome, toxic epidermal necrolysis (ten)
- Nexus Name Irks Author's Estate http://bit.ly/7Ar0dG (WSJ) - An excerpt from the article states that "As Google Inc. launches its Nexus One phone, one call that the company hasn't made is to the family members of science-fiction author Philip K. Dick, who complain the device's name infringes on one of Mr. Dick's most famous novels. "We feel this is a clear infringement of our intellectual-property rights," said Isa Dick Hackett, a daughter of Mr. Dick and the chief executive of Electric Shepherd Productions, an arm of the Dick estate devoted to adapting the late author's works. "Our legal team is dealing head-on with this," she said Tuesday. An attorney for the estate declined to elaborate on what legal steps it has taken. Philip K. Dick's novel, 'Do Androids Dream of Electric Sheep?,' was the basis for the 1982 film 'Blade Runner.' Mr. Dick's 1968 novel, "Do Androids Dream of Electric Sheep?," which served as the basis for the 1982 cult film "Blade Runner," follows a bounty hunter chasing androids known as Nexus-6 models. Ms. Hackett believes Google referenced that work in coming up with the name for its new phone, but the company never called her family or attorneys for permission to license the name. A Google spokesman declined to comment. Ms. Hackett argues the association between the phone and the book are cemented by the fact that the Nexus One runs Google's Android operating system. Google has its "Android system, and now they are naming a phone 'Nexus One,'" she said. "It's not lost on the people who are somewhat familiar with this novel." Attorneys who specialize in trademark disputes don't see a clear-cut case. One key issue is whether consumers are likely to be confused and think Mr. Dick's estate was associated with Google's phone. ”....
- FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy http://bit.ly/6UAozP (FDA) - An excerpt from the article states that "A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University. About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child. “This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice." To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about 1 million births over the past seven years (2001-2007). Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network. “This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children,” said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. “Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy.” The program blends clinical and research expertise and population-based databases from 11 health plan-affiliated research sites including Kaiser Permanente (Northern California, Southern California, Georgia,, Pacific Northwest, and Colorado regions); Harvard Pilgrim Health Care Institute, Group Health Research Institute, HealthPartners, Lovelace Clinic Foundation, the Meyers Primary Care Institute, and Tennessee State Medicaid, and the FDA. The HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, led by Richard Platt, M.D., M.S., is the coordinating center for the program. Lead researchers include Susan Andrade, Sc.D. HMO Research Network William Cooper, M.D., M.P.H. (Vanderbilt); Robert Davis, M.D., M.P.H. (Kaiser Permanente Georgia); Craig Cheetham, Pharm.D.; (Kaiser Permanente Southern California); and De-Kun Li, M.D., Ph.D. (Kaiser Permanente Northern California). The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, as well as studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes. A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. FDA epidemiologist, Pamela E. Scott, Ph.D., is the FDA project lead and chair of the Steering Committee.
- Outback Steakhouse Settles Sexual-Discrimination Suit for $19 Million http://bit.ly/8tBpip (WSJ)
- Studies Spotlight Problems in FDA Device Approvals http://bit.ly/517M3h (WSJ) - An excerpt from the article states that "Two leading medical journals have found flaws in how the Food and Drug Administration approves cardiovascular medical devices, saying some products reached the market based on tests that were inadequate and open to bias. The studies come as the FDA is facing intense pressure to overhaul the medical-device approval process following several incidents in which the agency acknowledged missteps, including the case of a knee device that was approved a year ago under political pressure. Jeffrey Shuren, acting director of the FDA's device division, acknowledged weaknesses in clinical trials used to approve some cardiovascular devices. One of the studies was co-authored by an FDA scientist. Dr. Shuren said the FDA has begun toughening standards for device approvals and intends to do more. Dr. Shuren said he wanted companies to work closely with the FDA in setting specific goals for their studies, which hasn't always been the case. "We want to be clear to manufacturers about what is expected of them," he said. He said the FDA is also reviewing clinical studies used to approve hip and spinal implants. The agency is asking companies to include more women in their studies and looking at approvals of pediatric devices, he said. Jeffrey Gibbs, a lawyer with the Washington firm of Hyman Phelps & McNamara, said spinal implants are a fast-growing segment of the medical device industry. "There has been concern within industry as well as the FDA that there wasn't enough robustness of the data, and some studies weren't well-validated," Mr. Gibbs said. The FDA device division has stepped up warning letters, recalls and other enforcement actions, he said........."
- As Bones Age, Who’s at Risk for Fracture? http://bit.ly/8ZFsw0 (NY Times) - An excerpt from the article states that "For the millions of Americans with bones that are thinning as they age, this question arises: Who should be treated with bone-enhancing drugs? Until recently, many doctors and drug companies that make these medications were saying almost everyone — especially older white women, who are at highest risk of one day suffering an osteoporotic fracture. These low-trauma fractures are debilitating and costly, adding more than $17 billion a year to the national health care bill. Among elderly people who fracture a hip, 10 percent to 20 percent die within six months; many more spend the rest of their lives in nursing homes or needing full-time home care. The National Osteoporosis Foundation reports that “about one out of every two Caucasian women will experience an osteoporosis-related fracture at some point in her lifetime, as will approximately one in five men.” “Although osteoporosis is less frequent in African-Americans,” the foundation continues, “those with osteoporosis have the same elevated fracture risk as Caucasians.” But the drugs currently available to enhance bone density are far from perfect. They are expensive, they can have side effects, and they are only about 50 percent effective at preventing fractures. Before any treatment, possible risks should be weighed against known benefits. If you have osteoporosis, defined as a T score — the standard measure of bone density — of minus 2.5 or lower, or you have already had an osteoporotic fracture of the forearm, hip, shoulder or spine, the answer is clear: treat. For you, experts say, the benefits of treatment are expected to far outweigh the risks. But what about the much greater number of women and men whose bones are not as strong as they were at age 30 but who have not yet become osteoporotic — with T scores in the hip or spine of minus 1 to minus 2.5? They are said to have osteopenia, which may or may not eventually lead to osteoporosis. Who among them would most likely benefit from treatment?”........"
- An Underground Campaign http://bit.ly/5yAdp5 (NY Times) - An excerpt from the article states that "LAWMAKERS debating health care reform in recent weeks haven’t been reticent about blaming trial lawyers for driving up the nation’s medical costs by pursuing large malpractice awards. Trying to fend off any limits to patient lawsuits, the lawyers decided to press their arguments in a new location — the subway system here. Lawmakers and their aides arriving on Capitol Hill by Metro, as the subway is known, pass through a blizzard of brightly colored ads on the platform and the walls and hanging from the ceiling. They bear the lawyers’ message that nearly 100,000 people die each year from medical errors, and that tort reform won’t fix the health care system. “We wanted a prominent space to educate key people about the number of people who are killed annually by medical errors,” said Anthony Tarricone, president of the American Association for Justice, formerly known as the Association of Trial Lawyers of America. The lawyers, who introduced their subway campaign this month, anticipated that they would be a target for senators looking to control health care costs, said Mr. Tarricone, a Boston plaintiffs’ lawyer. During the debate, several senators introduced amendments, including one called “loser pays” — meaning the person who loses the lawsuit must pay all the legal costs — to clamp down on medical liability lawsuits. None was adopted.The trial lawyers argue in the ads that patients need legal recourse because preventable medical errors are the sixth-leading cause of death in America, killing at least 98,000 people a year. (The ads’ tag line is: “Tell Congress to Put Patients First. There Are 98,000 Reasons Why You Should.”) The campaign Web site, 98000reasons.org, calls that number equivalent to two 737s crashing every day for a year — and the ads include two small images of planes. The figure comes from a 1999 report called “To Err Is Human,” from the federal Institute of Medicine, part of the National Academy of Sciences. This is the most recent nationwide figure, said Mr. Tarricone, who added that the number of deaths and injuries could be higher because the “problem has only gotten worse.”........"
- J&J expands recall of Tylenol arthritis caplets http://bit.ly/7ItTuA (Reuters) - An excerpt from the article states that "A voluntary recall of Tylenol Arthritis Pain Caplets is being expanded because of consumer reports of an unusual moldy odor with the 100-count bottles, the U.S. Food and Drug Administration said late on Monday. The FDA said it and Johnson & Johnson were expanding the recall to all available product lots of the pain caplets with the distinctive red EZ-open cap. The initial recall involved five lots of the product in November after reports of an unusual musty or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea, the FDA said. The agency said the odor was believed to have been caused by the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials........"
- Senior-citizen volunteers fight Medicare fraud http://bit.ly/8XBOl4 (PE.com) - An excerpt from the article states that "The first box that arrived at Shirley Shupp's door was filled with braces to help with her arthritis. Then came a motorized scooter, just like the one the 69-year-old already owned. She hadn't asked for any of it - but Medicare was apparently footing the bill. "There was just something that wasn't right about it," the Houston woman said. So Shupp contacted her local Senior Medicare Patrol, which did its own research and then referred the matter to investigators. The equipment, worth thousands of dollars, was returned, the case was handed over to prosecutors and the perpetrators were charged with Medicare fraud. The Senior Medicare Patrol is one of the least-known forces in the government's effort to eliminate such fraud, which drains billions of dollars a year. But it is seen as a valuable part of the Obama administration's bid to overhaul health care and bring down costs. The 4,700 senior citizen volunteers who serve as the government's eyes and ears have been credited with saving taxpayers more than $100 million since 1997. The program relies on elderly people to apply a lifetime's worth of common sense and skepticism. "They can tell when something just doesn't feel right to them," said Anne Gray, who works on the SMP program in Santa Ana, Calif. The patrol, which evolved from another program founded in 1995, now has at least one unit in every state. SMP sends its volunteers to senior centers, retirement communities and elsewhere to encourage Medicare beneficiaries to guard their personal information, beware of too-good-to-be-true offers on medical equipment and carefully review their benefit statements. The patrol also collects tips on potential scams and fields calls from senior citizens who believe their Medicare accounts have been fraudulently billed. When all they have is a whiff of something fishy, SMP participants often keep probing until they have enough information to send on to the FBI and investigators with the Centers for Medicare and Medicaid Services. "It really is detective work," said Barbara McGinity, director of the SMP in Houston........"
- Have acute pancreatitis? Go to a big hospital http://bit.ly/7ncxzY (Reuters) - An excerpt from the article states that "New research suggests that patients who go to hospitals that admit 118 or more people with pancreatitis each year experience shorter stays and lower death rates, and have lower hospital bills than patients who go to hospitals that admit fewer than 118 people with pancreatitis each year. In general, the hospitals dealing with more pancreatitis cases tended to be larger, urban, research centers and serve a greater black or Hispanic population. The findings, which appear in the journal Gastroenterology, are based on a review of more than 416,000 cases of acute pancreatitis treated in US hospitals from 1998-2006. Dr. Shimul A. Shah of the University of Massachusetts Medical School in Worcester and colleagues say reasons for the difference in outcomes from low- and high-volume hospitals may have to do with the availability of intensive care, specialists, and the latest technology at the various hospitals. "Given the rising incidence of acute pancreatitis and the reported costs exceeding $2 billion annually in the United States, our study suggests that referral of complicated cases of acute pancreatitis to high-volume centers should be discussed at a policy level," Shah and colleagues conclude........"
- FDA Says 'Unlikely' That Vytorin, Zetia Increase Cancer Risk http://bit.ly/4KW9Bm (WSJ) - An excerpt from the article states that "The U.S. Food and Drug Administration on Tuesday said it's "unlikely" Merck & Co.'s cholesterol drugs Vytorin and Zetia increase the risk of cancer or cancer-related death. Still, the FDA said it can't "definitively" rule out that the drugs may be associated with increased cancer risk. "Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out," the agency said in a posting on its Web site Tuesday. The FDA's views come after it finished a review of a clinical trial that shocked investors and the medical community when it showed an increased risk of cancer and deaths from cancer in patients taking Vytorin compared with those given a placebo. Vytorin is a single-tablet combination of the drugs simvastatin and Zetia, which work by different mechanisms to lower bad cholesterol. Simvastatin is sold by Merck under the brand Zocor, but has been available from several generic manufacturers after losing U.S. patent protection in 2006. ......."
- Court Affirms Injunction Against Microsoft http://bit.ly/68cQQV (WSJ) - An excerpt from the article states that "A federal appeals court on Tuesday affirmed a $290 million patent infringement judgment against Microsoft Corp. and reinstated an injunction that bars the company from selling current versions of its flagship Word software........"
- No link Seen Between Acetaminophen, birth defects http://bit.ly/5tkQUf (WSJ) - An excerpt from the article states that "Acetaminophen is the active ingredient in Tylenol and certain other painkillers, and is often found in over-the-counter cold and flu remedies. Taken as directed, acetaminophen is considered safe during pregnancy, making it the medication of choice for pregnant women's body aches and fevers. However, there are still some questions about whether the drug can contribute to birth defects. Studies looking at birth defects as a broad group have either found no link to acetaminophen use or have yielded inconclusive findings. Some research, meanwhile, has suggested that the drug may be linked to a higher risk of a birth defect called gastroschisis -- but other studies have found no such connection. Gastroschisis refers to a defect in the abdominal wall that allows the intestines to protrude; it has been linked to aspirin use during pregnancy. In the new study, researchers analyzed data from a large U.S. study that included more than 11,600 children born with congenital defects such as spina bifida, cleft lip and various defects affecting the brain, heart, lungs, limbs and gastrointestinal system. They were compared with 4,500 children born with no major anomaly.Overall, the study found, there was no evidence linking mothers' acetaminophen use in the first trimester to a heightened risk of any birth defect. In fact, women who took the medication to treat a first-trimester fever had a lower risk of certain birth defects -- including gastroschisis -- than women who did not treat their fevers with acetaminophen......."
- GE Sues a Doctor for Libel http://bit.ly/7CpwZE (WSJ) - An excerpt from the article states that "For a while now, the FDA and other regulators have been looking at safety risks associated with a few drugs patients sometimes take before getting MRI scans. While it’s common for new risks to crop up with established drugs, the Times of London this weekend highlighted an interesting twist in this case: GE has filed a libel suit in Britain against a Danish radiologist who gave a talk about the risks associated with Omniscan, a GE drug that’s one of the medicines regulators have been looking at. The doctor, Henrik Thomsen, gave a presentation to about 30 people two years ago in Oxford, the article says. He described a cluster of cases at his hospital in Copenhagen where kidney patients who received Omniscan developed a rare disorder called nephrogenic systemic fibrosis. One of the patients died......"
- Rare disease attacks, burns woman's skin http://bit.ly/6gtt9L (NY Times) - An excerpt from the article states that "Ten years ago, a national panel of health care experts released a landmark report on medical errors in the American health care system. Published by the Institute of Medicine, “To Err is Human: Building a Safer Health System” estimated that as many as 98,000 people died in hospitals each year as a result of preventable mistakes. Being hospitalized, it turned out, was far riskier than riding a jumbo jet. While the report offered comprehensive strategies to improve safety, its main conclusion was that medical errors were primarily a result of “faulty systems, processes and conditions that lead people to make mistakes or fail to prevent them.” Spurred on by this finding, health care leaders across the country began addressing errors believed to be a result of systemic flaws. They instituted more rigorous hospital accreditation standards and procedures, increased public reporting and transparency and established systemwide safety changes like the mandatory use of checklists, the placement of hand sanitizing gel dispensers throughout hospital wards and the regulation of physician duty hours. For nearly a decade, this paradigm of systems failure defined the national movement to improve patient safety. But more recently, some health care safety experts have begun questioning the assumption underlying the report’s conclusions: that only health care systems, and not individual clinicians, could be held accountable for medical mistakes. Dr. Robert M. Wachter, a professor of medicine at the University of California, San Francisco, and a national leader in patient safety, recently published two critiques of the safety movement, one in Health Affairs and one in The New England Journal of Medicine. Both urge physicians to begin acknowledging their individual roles in medical errors. “A blame-free culture carries its own safety risks,” he writes. “As we enter the second decade of the safety movement, while the science regarding improving systems must continue to mature, the urgency of the task also demands that we stop averting our eyes from the need to balance ‘no blame’ and accountability.”......"
- Rare disease attacks, burns woman's skin http://bit.ly/4NBBlW (Fox) - An excerpt from the article states that "Two weeks ago, Yasmin Hernandez was a vibrant, loving woman, devoted wife and mother of five young children. Now, she lies in a hospital bed, heavily sedated, because her skin is burning from the inside out. And her family is asking for prayers. Hernandez has developed toxic epidermal necrolysis, a condition so rare that the chances of getting it are about one in a million. Toxic epidermal necrolysis, or TEN, is the more severe form of Stevens-Johnson Syndrome, both of which are skin diseases that are caused by a reaction to medication. FOX 13 medical reporter Dr. Joette Giovinco says the medical field is still unclear about pinpointing the exact mechanism that causes TEN and SJS. "Medications can precipitate it. Antibiotics, non-steroidal, anti inflammatory drugs, anti-seizure drugs, anti-psychotic drugs," Giovinco said. Yasmin's husband Benjamin says his wife took a drug on December 3 to treat bipolar disorder before she got sick. "She had a fever of 109. I thought my thermometer was broken. I rushed her to the hospital," Benjamin said. Now, the blistering from TEN is literally burning Yasmin's skin off her body, and she is bandaged from head to toe. She is on a ventilator at an Orlando hospital, and her husband says she stands a 30 percent chance of survival......"
- 26 Arrested in Three States in Medicare Fraud Schemes http://bit.ly/7sNSQP (NY Times) - An excerpt from the article states that "Federal agents arrested 26 suspects in three states on Tuesday, including a doctor and nurses, in a crackdown on Medicare fraud totaling $61 million.
Yudel Cayro was among those arrested in Miami on Tuesday. Arrests in three separate cases in Brooklyn, Detroit and Miami included a Florida doctor accused of running a $40 million home health care scheme that falsely listed patients as blind diabetics so he could bill for twice-daily nurse visits. The Department of Justice and the Department of Health and Human Services said 32 indicted suspects lined up bogus patients and otherwise billed Medicare for unnecessary medical equipment, physical therapy and infusions for H.I.V. The doctor in Miami, Dr. Fred E. Dweck, along with 14 people with whom he worked, was accused in an indictment of running a scam to tap a Medicare program that pays high rates to care for the sickest patients. Dr. Dweck referred about 1,250 Medicare beneficiaries for expensive and unnecessary home health and therapy services, the indictment said, and bribed the owners of two clinics in Miami to join the scam. He also faked medical certifications, according to the indictment......."
- Aviation Injuries, Aloft and on the Ground http://bit.ly/5aOSmc (TCEQ) - An excerpt from the article states that "More than 1,000 people a year are hospitalized for aviation-related injuries, with only one-tenth of them passengers in commercial aircraft. Researchers have analyzed data from 2000 through 2005, gathering information on crashes, parachuting accidents, airport maintenance worker injuries and passenger injuries sustained on the ground, among others. The report, which appears in the December issue of Aviation, Space, and Environmental Medicine, uses a group of health care databases maintained by the federal government’s Healthcare Cost and Utilization Project. Only 10.6 percent of those hospitalized were traveling in commercial aircraft. More than 32 percent were injured in private planes, and almost 11 percent in gliders or hang gliders. Unsurprisingly, jumping out of an airplane is quite dangerous: 28.9 percent of those injured were parachutists. More than 28 percent of all injuries were to the lower limbs. And while burns were seen in just 2.5 percent of the patients, they accounted for 17 percent of deaths after hospitalization....."
- Cleanup in Midland County: West County Road 112, Midland, TX Information on the chromium contamination in the groundwater near West County Road 112, Midland, TX. http://bit.ly/5ZvyJr (TCEQ) - An excerpt from the article states that "On April 8, 2009, the TCEQ collected a groundwater sample from a water well on West CR 112 that indicated hexavalent chromium at 5250 parts per billion. The maximum contaminant level (MCL) for chromium is 100 parts per billion. Additional private-water-well sampling has been performed on West CR 112. Several of these sampled wells indicated levels of hexavalent chromium above the MCL. The source of the contamination is still undetermined.Current Activities The TCEQ has extended its current sampling area and will continue to expand the sampling area until the extent of the contamination is defined. To date, approximately 234 water wells have been sampled and the TCEQ has installed approximately 41 anion-exchange water filtration systems at homes where total chromium has been detected above the MCL. Due to fluctuations in total chromium levels in groundwater, some of the wells with filtration systems currently show total chromium levels below the MCL. This finding is not unusual due to the dynamics of groundwater flow in the Trinity aquifer. With respect to chromium, the anion-exchange filtration systems provide water that is safe for all household uses. These filtration systems are currently being installed and maintained at no cost to the homeowner. The TCEQ has screened area wells for Volatile Organic Compounds (VOCs), Semi-Volatile Organic Compounds (SVOCs), and Total Petroleum Hydrocarbons (TPH). No other contaminant plumes have been identified. No other contaminants have been identified that would interfere with the filtration systems. TCEQ continues to sample wells with filters to monitor the filtration systems and will resample wells outside the currently established groundwater plume to monitor plume movement. The TCEQ held a community meeting on May 28, 2009 at 7:00p.m. at the Midland County Horseshoe, 2002 Cotton Flat Road, Midland, TX. A powerpoint slideshow was presented. On June 3, 2009 the Texas Department of State Health Services, in cooperation with the U.S. Department of Health and Human Services Agency for Toxic Substances and Disease Registry, completed a letter health consultation which evaluates the potential health effects of chromium in private water wells in the area around West County Road 112 in Midland, Texas. A community meeting was held on Tuesday, June 30, 2009 at 6:00 p.m. at the Midland County Horseshoe, 2002 Cotton Flat Road, Midland, TX. A powerpoint presentation was shown. An Open House Availbility Session was held on Thursday, September 24, 2009, from 6:00p.m. to 8:00p.m., at the Midland County Horseshoe, 2002 Cotton Flat Road, Midland, TX. The Open House Availability Session was of an informal come-and-go format that allowed for one-on-one questions and answers between residents and staff from the TCEQ and Midland County....."
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