Wall Street Journal: Health Blog

There have long been safety questions — and lawsuits — over whether bone-building drugs like Merck’s Fosamax can actually increase the chance of femur fractures. Today, the FDA said it was going to take another look at the safety issues.

In a posting on its Web site, the FDA said a 2008 examination of data from makers of osteoporosis drugs containing bisphosphonates didn’t show that women taking the medications had an increased risk of fracturing their femurs — the bone just below the hip joint.

But studies released today at the annual meeting of the American Academy of Orthopaedic Surgeons raised new questions about the risks for long-term use of bisphosphonates by post-menopausal women. USA Today has more.

In its latest review, the FDA said it would work with outside experts on the matter. While that’s happening, people on the medications should continue taking them but should talk to their doctors if get any new hip or thigh pain, the agency said.

Bisphosphonates have combined annual sales topping $3.5 billion. In addition to Fosamax, drugs in the group includes Actonel marketed by Sanofi-Aventis and Procter & Gamble, Boniva marketed by Roche and GlaxoSmithKline, Novartis’s Reclast and P&G’s Actonel. Reuters and Dow Jones Newswires have more details.

Merck is defending itself against more than 900 product-liability lawsuits by patients mostly claiming Fosamax caused death of their jaw-bone tissue. The FDA more recently has held up approval of other drugs in the bone-treatment pipeline as the agency has sorted through a variety of safety concerns.

Photo: Associated Press

The Orphan Drug Act has been around since 1983 offering tax incentives and competition protection for drugs aimed at treating rare diseases. But there have been relatively few orphan drugs developed, so the FDA is beating the bushes for more participation.

FDA staffers recently ran a two-day workshop in Claremont, Calif., to help drug developers fill out the application to get orphan-drug status, the WSJ says in an article this morning. Another workshop is planned for the University of Minnesota in August and there’s talk about doing one in Europe.

There are roughly 350 orphan drugs currently approved, covering about 150 rare diseases. The core requirement for orphan status is that the medicine treats a disease affecting fewer than 200,000 Americans, a limited market that often makes such treatments very expensive. Last year, 250 requests for orphan designation were filed with the FDA, and 160 received it.

Of course, getting more applications doesn’t mean more drugs will make it through the FDA approval process, orphan status or not, the WSJ notes. But the FDA officials with the orphan program hope that increasing the application pool will boost the chances of getting more rare-disease treatments to market.

The first workshop drew 29 potential sponsors, three-quarters of which said they had never filed an orphan-drug application before. Not that the process is really that hard. “It’s not ‘War and Peace,’ ” an FDA official told the WSJ. “The applications are six or seven pages.”

Case history bonus: See here for the story of a mother seeking orphan status for a drug to help her twin girls with a rare but deadly cholesterol metabolism disorder.

It’s crunch time in the fight over a health-care bill, so groups for and against the legislation are getting ready for a final push before congressional votes that could come later this month.

These efforts take money, of course, and advocate groups have put together war chests, much of it slated to go to advertising. Here are some of the spending plans outlined in a WSJ report this morning:

• A business coalition backed by the U.S. Chamber of Commerce and other groups will allocate between $4 million and $10 million on anti-bill ads. They will be targeted against several dozen Democratic lawmakers with the message that the changes would cause job losses.
• Another anti-overhaul group, Americans for Prosperity, will use radio and TV ads in about 21 House districts, spending $350,000. It also plans rallies at lawmakers’ district offices.
• Some labor unions and progressive groups called Health Care for America Now are running $70,000 in TV ads in Washington. The ads tell Congress to “listen to us, not the insurance companies. Pass health-care reform now.”
• Seniors group AARP, a heavy spender on TV ads backing a revamp earlier, now is concentrating on contacting constituents in districts with wavering lawmakers to boost support for the bill.

Meanwhile, the health insurance industry is starting to show ads on cable TV networks aimed at blunting White House criticism of insurance rate increases, USA Today reports. The industry group America’s Health Insurance Plans says it’s spending at least $1 million on the ads, but won’t elaborate.

More than $200 million was spent on ads during the overhaul debate last year, making the health-care fight the largest single advocacy campaign ever, according to Campaign Media Analysis Group, which tracks issue advertising. Spending on both sides was about equally split last year, the group tells the WSJ.

Photo of Washington protest Tuesday by Agence France-Presse/Getty Images

Another day, another stock-price jump.

First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.

The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.

This all comes as good news for investors in InterMune, whose shares streaked nearly 60% higher Friday because the questions posed by the FDA staff for today’s advisory committee meeting weren’t uniformly negative.

The stock price then barely budged yesterday and trading in the shares was halted today in anticipation of the meeting news. But in after-hours trading today, the news sent the shares soaring up 65% to $38.43. That compares with the stock’s price under $15 at the close last Thursday.

The experts voted 7-5 on the question of data for pirfenidone showing “substantial evidence” of effectiveness. The medicine passed the safety vote 9-3. InterMune had told the panel that “pirfenidone provides a clinically meaningful benefit to patients by reducing decline in lung function.”

Panel member Leslie Hendeles of the University of Florida told Dow Jones Newswires that he didn’t think the data met FDA’s substantial-effectiveness test, but he voted in favor of the medicine because he would want a chance to take the drug if he were diagnosed with pulmonary fibrosis.

The FDA is giving the InterMune drug candidate a priority review process that’s reserved for advances over existing treatments. There aren’t any FDA-approved drugs now for IPF. Here’s more on the disease.

African-Americans are twice as likely as Caucasians to have Alzheimer’s and related memory-robbing diseases, and Hispanics, the fastest-growing segment of the U.S. population, are 1.5 times as likely, according to a new report released this morning by the Alzheimer’s Association.

The higher risk is likely linked to factors like high blood pressure and diabetes, which are risk factors for dementia and more common among those minority groups than among Caucasians.

Yet, African-Americans and Hispanics are less likely to be diagnosed with the disease than their Caucasian counterparts. One barrier to diagnosis of dementia among these populations is access to proper health care, Maria Carrillo, a spokeswoman for the association, told the Health Blog. Language and culture, such as the custom of taking care of individuals within one’s family, could also be contributors, she said.

Alzheimer’s, which affects some 5.3 million people in the U.S., is the seventh leading cause of death. Health care and long-term care costs for these patients total $172 billion annually, according to the report. And, when a patient has Alzheimer’s on top of a medical condition, “the net result is elevated cost,” said Carrillo. For instance, Medicare payments are nearly three times higher for those aged 65 and older with Alzheimer’s than those of the same age without the disease.

Photo: Associated Press

President Obama was back on the campaign trail Monday, using his election-style oratory to stump for a health-care overhaul that still awaits an uncertain fate in Congress.

As is the case routinely these days, the president took aim at health insurers. He lambasted them 22 times in a speech to a college audience near Philadelphia, according to the Washington Post. “How much higher do premiums have to rise until we do something about it,” Obama said in the speech punchline.

HHS Secretary Kathleen Sebelius yesterday also sent off a letter to officials of big health insurers calling for them to publicly justify their proposed hikes in insurance premiums. This follows the in-person grilling the execs got in Washington last week. Here’s more from the WSJ.

Meanwhile, part of the latest Obama overhaul proposal that is supposed to help hold down those premiums got some negative reviews this morning. As proposed by the president, the Health Insurance Rate Authority overseen by HHS would have the power to survey health-insurance premium increases and step in to thwart those considered excessive.

But there could be a problem with that setup, the New York Times reports. It notes that while federal officials are focusing on holding down premiums, state officials will have to make sure of the solvency of the insurers they regulate.

Of course, curbing premiums doesn’t necessarily do anything to hold down the cost of providing care — the things that doctors and hospitals charge for. “You can’t separate the underlying solvency of companies from the rates they charge,” the Wisconsin insurance commissioner tells the NYT.

Chances have been good that Sanofi-Aventis and Merck would re-establish their animal-health joint venture, as company officials have been more than hinting for months. Today, the reunion plans became official.

The combined business would be the largest seller of animal drugs and vaccines in the world, the companies said, although the deal still will have to pass muster with antitrust watchdogs. Here’s more from Dow Jones Newswires and Reuters.

Of course it was because of antitrust reasons that the companies had to break up their joint animal business called Merial last year. Merck was taking over Schering-Plough, which also had significant animal-health operations, so Merck sold its 50% Merial stake to Sanofi for $4 billion. The companies figured they might together again on animal care down the road.

Now, the planned combination of Merial with the Merck-owned Intervet/Schering-Plough business would surpass No. 2 Pfizer in animal-health sales, even after any divestitures, officials said. One area in which the venture may have to dispose of operations is poultry vaccines, where their combined market share would be about 75%, DJ Newswires notes.

Why all this interest in taking care of animals? Sanofi CEO Chris Viehbacher said it was because of growth expected in emerging markets and because of an aging population, which is seen as favorable to pet ownership, according to Reuters.

The animal-health market is estimated at $19 billion, and should grow 5% annually through about 2014, the companies said. They hope the deal will close within 12 months.

Photo: Bloomberg News

The sales volume of soda and other drinks shipped for sale at U.S. secondary schools has dropped 72% since late 2004, resulting in an 88% drop in beverage calories sold in schools, drink makers said today.

Local and state regulations aimed at curbing sweetened beverages in schools explain part of the decline, but a report by the American Beverage Association also says its efforts played a big role, according to the WSJ. Soft-drink consumption nationwide is also down, but the report by the industry group didn’t look at consumption habits by kids out of school.

The results come as efforts to fight childhood obesity have gotten a recent boost from First Lady Michelle Obama Let’s Move drive and other pushes. Beverage makers pledged in 2006 to push to eliminate sales full-calorie sodas in schools, joining in a drive with the American Heart Association and the William J. Clinton Foundation. American Heart Association President Clyde Yancy told the WSJ he was “really floored” by the decline in soda with calories sold and the change in product mix.

The drop in school consumption might become a talking point for the industry to argue against taxes on sweetened drinks that are getting more attention from politicians facing budget gaps. NYC Mayor Michael Bloomberg said yesterday said that such a state tax proposed in New York ”just makes sense” to fight obesity and help with deficits.

New York state has been down the road before, but a 2009 effort stalled in the face of fierce opposition. The latest proposed tax would raise an estimated $1 billion in annual revenue and would be dedicated mostly to health-care spending, the New York Times reports.

In Philadelphia, city officials have proposed a tax on sweetened beverages they say would raise $77 million a year.

Photo: iStockphoto

The FDA staff said it has a bunch of questions about InterMune’s new drug to slow deteriorating lung functioning. But investors figure the concerns weren’t as bad as they could have been, sending the biotech’s shares soaring.

The stock jumped as much as 74% after FDA reviewers said only one of InterMune’s two late-stage trails for the experimental drug pirfenidone had met its main goal and added that “the clinical significance of the treatment effect size is uncertain.” The FDA documents, which were released ahead of an advisory panel meeting to discuss the drug Tuesday, also had a mix of other things to say.

All things considered, an Oppenheimer analyst noted the “tone was less negative than expected,” all things considered and there was room for the drug to still get FDA approval. The shares settled down in later trading, but still finished up nearly 60% for the day.

InterMune often appears on lists of likely biotech takeover candidates. FDA approval of pirfenidone would give it two drugs on the U.S. market.

The new drug would treat idiopathic pulmonary fibrosis, which affects about 200,000 Americans, the majority of whom eventually die of respiratory failure. The FDA noted that there aren’t any approved drugs to treat IPF, although drugs like corticosteroids and drugs that suppress the immune system are used, according to Dow Jones Newswires.

The company also put out material noting that “the slowing of progression in loss of lung volume constitutes a clear benefit to patients,” Reuters said. Here’s more from the company.
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The overhaul swirl of late has been focused largely on medical costs, insurance regulation, coverage mandates and the like. One pivotal issue has gotten less attention: abortion.

Republicans remain opposed to the health-care revamp, whether or not the legislation bans the use of federal money for abortion. But as many as a dozen Democrats in the House – a big number in this showdown – could vote against the overhaul if it doesn’t contain stiffened abortion restrictions like what House passed in November, Rep. Bart Stupak has said.

There’s no solution to the impasse yet, but Democratic leaders are urging their fold to avoid making abortion a deal breaker. “This is not about abortion,” said Speaker Nancy Pelosi said yesterday, the Associated Press reported. “This is a bill about providing quality affordable health care for all Americans.”

But the divide remains. Actually, neither camp on the abortion issue like mild abortion restrictions that passed the Senate in December, which is supposed to serve as the basis for the final legislation.

“Abortion rights advocates have grown increasingly convinced that the language would restrict the reach of abortion coverage nearly as much as the Stupak language in the House bill passed in December,” the Washington Post said this morning. (The Stupak measure would require abortion coverage to be purchased separately to avoid using federal subsidies for health insurance.)

Politico reported that Roman Catholic bishops have signaled that they could reach agreement with House leaders on anti-abortion language, the church would work to get the votes needed to protect those provisions in getting through the Senate. Approval in the Senate of abortion provisions still would need 60 votes to avoid GOP attempts to block it.

The government said this morning that the unemployment rate held at 9.7% in February for the second month in a row. The health-care sector added 12,000 jobs.

That continues the series of monthly job gains that has made health care an economic bright spot since the start of the recession. Read the latest Bureau of Labor Statististics summary.

For February, the subsector for ambulatory health-care services posted the largest runup, adding 6,700 jobs. Nursing and residential-care facilities hired another 4,000, according to the BLS breakdown.

Bonus: The economy and still-high unemployment rate may help explain why seasonal flu has seemed so mild this winter, according to research cited by our colleagues at the Real Time Economics blog. You can read why here.

Image: iStockphoto

Here’s a winter storm warning: show up for work during a blizzard or lose your job.

Washington Hospital Center has fired eight more employees who didn’t show up for work during last month’s snowstorms that blanketed DC, the Washington Post reports today. That’s on top of 16 workers who had been previously fired. Three of those people have now been rehired, putting the termination count at 21 — 15 nurses and six support people, according to the WaPo.

The storms were doozies but the hospital prided itself on keeping operations as normal as possible (see video below). In a staff memo released by the hospital, CEO Harrison J. Rider III said that “most of us served selflessly, but some chose not to come to work and walked away from the commitment they made to the patients and their fellow associates.” See more in this report.

Union officials said they were “bewildered” by the firings and an official of the American Nurses Association told the Post she didn’t know of any other hospital taking similar action. Union reps said about 250 of the hospital’s 1,600 nurses didn’t report for shifts at some point during Washington’s storms between Feb. 5 and Feb 11, according to the paper.

Washington Hospital Center is the district’s largest private hospital with 926 beds. Among its services, it has a big kidney transplant unit (see here for a neat chart on a 13-way kidney exchange done in with Georgetown University Hospital).

Here’s a look at storm conditions at the hospital from a YouTube video:

Cancel-button photo by greefus groinks via Flickr

Five CEOs from the health-insurance big dogs (UnitedHealth, WellPoint, etc.) are at the White House this morning to discuss — or more accurately, take flack — over the health overhaul’s issue de jour: rising insurance premiums.

The leadup to the meeting has been disorganized and it’s hard to figure out what’s going on or who is really going to take the CEOs to task. HHS pushed out a press release on Feb. 24 saying the meeting would be yesterday at the department’s HQ.

Then the meeting got moved up to today and relocated to the White House. Rumors are swirling that President Obama himself might sit down with the CEOs for a friendly chat.

The insurance honchos, including WellPoint’s Angela Braly, UnitedHealth’s Stephen Hemsley, Cigna’s David Cordani, Health Care Service Corp.’s Patricia Hemingway Hall and Aetna’s Ron Williams, are expected to keep pressing the point that rising premiums are due to underlying medical costs that are rising at an alarming clip. Execs and their trade group have said hospitals are asking them for 40% reimbursement increases and to pay for high-end biotech drugs that are running into the hundreds of thousands of dollars.

What’s likely to come out of the confab? It’s an opportunity for the White House to push the health overhaul by continuing to stoke what it has seized on as a signature issue –- the 39% rate increase that WellPoint asked for in California’s individual market. But like last week’s bipartisan health summit, it’s likely to end up being little more than an exchange of talking points.

Update: Maybe this wasn’t a routine exchange of talking points, after all. The Health Blog talked to four of the five big dogs in attendance in the Roosevelt Room this morning and they all reported that the tone shifted from the politically charged rhetoric of recent weeks to something more constructive. Obama did make a cameo, to read a letter from a health-plan member in Ohio with a 40% premium increase, which sparked some constructive discussion. Wonders never cease.

Image: iStockphoto

The FDA plans to increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division, which has been under attack in Congress and is criticized in a new government report, the WSJ said this morning.

In a letter to Sen. Chuck Grassley, the FDA says an internal committee has recommended that the FDA and its Office of Criminal Investigations “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.”

A report set to be released today by the Government Accountability Office, Congress’s watchdog arm, says the Office of Criminal Investigations has operated autonomously for years with little or no accountability to top FDA officials. It said the investigations office’s whose budget rose 73% between 1999 and 2008 to $41 million, has fallen short compared with other agencies in developing performance standards.

The FDA officials largely agreed with the assessment and in the letter to Grassley, it said the agency is “developing meaningful performance measures” for the criminal office as part of an initiative begun in August. The FDA said it wants the criminal office to share information with FDA leaders regularly, and to do a better job picking cases.

Last year federal appellate Judge Richard Posner in Chicago slammed the government over a case originated in the FDA’s criminal office against a salad-dressing wholesaler. The government charged the wholesaler with changing the labels on 1.6 million bottles of salad dressing to extend their shelf life, and in 2007 won a conviction for “misbranding.”

The wholesaler contended that the FDA had no regulations covering such labeling, and Judge Posner agreed. “The testimony of the FDA’s employee was not just improper and inadmissible but incoherent,” the judge said in his opinion.

Update: You can see the GAO report here and other GAO info here.

All is not well in the land of insulin pumps — the devices that deliver insulin to mostly Type 1 diabetics — and the FDA wants to put a spotlight on the problem.

Noting that there had been 18 recalls of pumps over five years because of hardware and software problems, the FDA said that “device problems critical to insulin pumps exist across manufacturers.” The agency has called a meeting of outside experts for Friday to see what can be done about the risks.

The FDA didn’t cite particular manufacturers, but insulin-pump makers include Johnson & Johnson, Medtronic and Roche Holding. See comments from those companies and other details from Reuters and Dow Jones Newswires.

People with Type 1 diabetes produce little or no insulin and increasing numbers are using insulin pumps to administer doses of the hormone. Defective pumps can allow blood sugar to rise too low or too high, which can be fatal.

Some 375,000 adults with Type 1 diabetes used pumps in 2007 and there were nearly 17,000 reports of health problems over the three years ended in 2009, according to the regulators. Makers are required to report problems potentially connected with devices to the FDA.

Such reports don’t mean there is necessarily something wrong with a device or that it caused harm, but FDA reviewers found many reports “have not been thoroughly investigated and evaluated by manufacturers in determining causality and device failure,” according to the FDA. Of 310 deaths examined, for example, it said “the device problem was unknown and limited details of the event were provided” in 225 of the death reports.

Bad news on the Alzheimer’s drug development front: Pfizer and Medivation announced negative results from a large late-stage trial of Dimebon, thought to be a promising treatment more potent than those currently on the market.

Dimebon, you may remember, got its start a quarter-century ago as a Russian cold medicine that Pfizer plunked down $225 million for licensing rights in 2008. The deal also included potential milestone payments of as much as $500 million.

The drug, considered to be the compound furthest along of those in development to treat Alzheimer’s, had shown impressive effects in a trial 183 Russian patients. But scientists in the field have questioned the small size of the study and the whether the findings could be applied to other populations since it was conducted in Russia.

The companies say it’s too early to say why the results look they way they did. Pfizer and Medivation now will do a deep dive into the data to figure out if there were any mix-ups or “subleties” in the study design that might be responsible, and whether there might be subgroups in the study population who did benefit, Briggs Morrison, who oversees Pfizer’s clinical development of late-stage Alzheimer’s compounds, told the Health Blog.

Many experts and investors are disappointed by the news. Medivation’s stock plunged nearly 68% after the results came out. Read more from DJ Newwires here.

While it’s too early to tell what this means for Dimebon, the results remind us that “there are no sure things in the pipeline,” Robert Egge, VP of public policy and advocacy at the Alzheimer’s Association, told the Health Blog.

Image of neuron: iStockphoto

A version of this post by WSJ’s Jean Spencer also appears on the Washington Wire blog.

A coalition of consumer, public-health and food-safety advocates is trying to jumpstart the food-safety legislation that is stalled in the Senate.

To make its point, the Make Our Food Safe coalition is trumpeting a report by Ohio State University economist and former FDA official Robert Scharff that concludes that health costs associated with foodborne illnesses totals $152 billion annually in the U.S.

The report was commissioned by Georgetown University’s Produce Safety Project, a coalition member that has been advocating for tougher food-safety rules. It also includes a state-by-state cost analysis that illustrates how much each state spends on foodborne illness, as well as a cost-per-illness breakdown.

Scharff looked at 28 pathogens, including “unknown agents,” and the costs associated with illnesses, including physician visits, hospital charges as well as “quality of life losses” such as pain, suffering and death. He figured that each case of salmonella, which was linked to a large peanut-product recall begun in 2008, costs about $9,146, while E. coli 0157:H7, which was linked to spinach and cookie dough, costs about $14,838 per illness.

The food-safety bill that passed the House in July would give the FDA authority to recall products, require more frequent FDA inspections of food-processing plants and better recordkeeping by food companies so contaminated products could be more easily traced. Similar legislation in the Senate has taken a backseat to health-care overhaul legislation and other priorities.

It’s not as if food safety has completely fallen off the legislative platter. Democrat Sen. Tom Harkin said food safety legislation could reach the Senate floor around Easter and be “on the president’s desk by May.”

Other coalition members include the American Public Health Association; the Center for Foodborne Illness Research & Prevention; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; and the Pew Charitable Trusts.

For a CDC report published last year the most common types of foodborne illness in the U.S. and our post on it, see here and here.

Image of salmonella at 8,000X magnification by CDC/Bette Jensen

Lots of health headlines this morning, most surrounding the Democratic overhaul efforts. Meanwhile, the Senate figured out a way to avoid crimping Medicare payments to doctors.

President Obama kicked things off yesterday by saying he was open to a few cost-saving ideas that Republicans highlighted at last week’s bipartisan health summit. In a letter to congressional leaders, Obama proposed adding four GOP-backed items to the health-care mix that House and Senate Dems now are expected to put to votes later this month.

Republicans weren’t mollified by the presidential gesture, saying adopting a few of their ideas wasn’t enough to rectify the nearly $1 trillion overhaul package. Obama is slated to speak more about the latest health-care push in remarks at the White House today. For more, see here, here and here.

The measures listed by the president would included beefing up fraud prevention and expanding Health Savings Accounts. Two other ideas he wants to pursue should warm the hearts of many doctors: finding alternatives for settling malpractice suits and boosting Medicaid reimbursements for doctors, especially since the overhaul will be adding Medicaid benefits for more recipients that will need doctors.

Docs participating in the Medicare program also got good news yesterday when the Senate overcame Sen. Jim Bunning’s objections to a $10 billion bill that included a 30-day delay in a 21% Medicare payment cuts to physicians. Extending health-insurance subsidies under the Corbra program also were part of the package, along with highway funding, jobless benefits and a hodgepodge of other provisions.

For more on the Bunning saga, read here, here and here as well as our posts here and here. Senate Majority Leader Harry Reid has proposed a one-year extension of higher Medicare payments for doctors that would also give states help with their Medicaid budgets.

White House Update: As expected, President Obama asked lawmakers to vote on health-care overhaul legislation “in the next few weeks,” signaling he will push approval even without Republican support. Obama will go on the road with his health-care message next week, speaking in Philadelphia and St. Louis on Monday and Wednesday, respectively. See more here.

The American Cancer Society put out updated guidelines for prostate cancer screening today and they look, well, a lot like the current ones.

After reviewing the recent scientific literature, there’s still no evidence that routine screening for men of any age makes sense, according to the committee that issued the guidelines.

They continue to recommend that men of average risk receive information and weigh the “uncertainties, risks, and potential benefits” of screening starting at age 50. Higher-risk individuals — African-Americans or those with one relative diagnosed with prostate cancer before age 65 — should be presented with the information at age 45. Men with a strong family history should start thinking about screening at age 40.

The group also emphasizes the importance of joint decision-making between the patient and his doctor about whether to be screened for prostate cancer. Men don’t always get the information they need to make such decisions about prostate screening, according to the cancer society and findings from other studies.

“Men without access to regular care should not be tested unless high-quality informed decision-making as well as appropriate counseling and follow-up care for those who test positive can be assured,” Otis Brawley, chief medical officer of the American Cancer Society said in a statement. “Without those, community-based screening should not be initiated.”

Prostate cancer screening has long been debated. That’s because screening for slow-growing diseases, like prostate cancer tends to be, may lead to unnecessary treatment.

It seemed like only a question of time, but Bristol-Myers Squibb said this afternoon that Lamberto Andreotti, its president and chief operating officer since last March, would succeed James M. Cornelius as CEO.

Andreotti, a 12-year veteran of the company, is 59 years old and Cornelius is 66. Cornelius was tapped as Bristol-Myers CEO in 2006 (first on an interim basis) and then got the added job as chairman in 2008. Picking a successor was one of his key missions.

Andreotti takes command after Bristol-Myers decided to sit out the wave of multibillion-dollar takeovers that saw big competitors Pfizer, Merck and Lilly get even bigger. Bristol-Myers instead has pursued smaller biotech deals and alliances as well as developing its own pipeline through what it called a “string of pearls” strategy. The company also decided to shrink its non-core units with the split-off of its Mead Johnson baby-formula business.

Looking ahead, Bristol-Myers will have to cope with the loss of patent protection for money spinners like the company’s anticlotting pill Plavix, the world’s second best-selling drug after Pfizer’s Lipitor. The company has cut costs through layoffs, plant closures and wage freezes, Dow Jones Newswires notes.

Cornelius will remain as the drug maker’s chairman when the switch is made May 4. In 2008, his compensation topped $21 million.

Photo: Bristol-Myers Squibb via Bloomberg