Author: Jacob Goldstein

An injury treatment popular with professional athletes failed in a study published this week in the Journal of the American Medical Association.

The treatment is called platelet-rich plasma injection. The doctor takes some of the patient’s blood and uses a relatively simple technique to separate out the platelets, some of which are then re-injected at the injury site. The idea is that the platelets stimulate the repair of injured tissue.

In the new study, 54 patients with injured Achilles tendons were randomly assigned to undergo PRP or receive a placebo shot of saline. Both groups also did standard rehabilitation. There was no statistically significant difference between the two groups, which were compared six weeks, 12 weeks and 24 weeks after undergoing the procedure.

PRP got a big publicity boost about a year ago, when Hines Ward and Troy Polamalu of the Pittsburgh Steelers used platelet-rich plasma therapy while they were on the way to winning the Super Bowl; a story on the procedure landed on the front page of the New York Times last February. Another famous patient: Tiger Woods, who reportedly had the procedure in his knee several times last year.

Earlier studies (such as this one, of patients with tennis elbow) had shown promise, but those studies typically included few or no patients who were randomly assigned to receive a placebo.

Though the procedure remains unproven, it may yet bear out for some injuries. Lots of other studies of PRP are underway, for problems such as injured knees and damaged rotator cuffs.

The JAMA study was funded by Biomet, a medical device company, and conducted by doctors in the Netherlands.

Photo: Associated Press

J.P. Morgan is hosting its big drug-industry conference this week in San Francisco. Here are a couple tidbits from the first few days:

Sales of the multiple sclerosis drug Tysabri topped $1 billion last year, Biogen Idec said today, and the number of patients taking the drug neared 50,000.

On the one hand, that’s notable, given that the drug (which Biogen co-markets with Elan) was pulled from the market in 2005 because of safety concerns. On the other hand, Biogen recently said its CEO will step down later this year, a move that Dow Jones Newswires said was linked in part to concerns about Tysabri’s growth trajectory. The CEO, James Mullen, will be speaking at the conference at 4:30 Pacific time today. You can tune in online.

Biogen Update: Mullen said that there were 28 known cases of a rare brain infection in M.S. patients receiving Tysabri treatment as of mid-December. That’s up from 24 that regulators reported in October. Here’s more from DJ Newswires.

Dendreon now has about $600 million in cash, which came largely from a supplemental stock offering in December. Dendreon has had a long road trying to win FDA approval for Provenge, a vaccine intended to treat advanced prostate cancer; a decision from the FDA is expected by May 1.

The vaccine is tailored to each patient; manufacturing it is a complex chore that involves taking cells from the patient and shipping them to the company for processing. The company is using some of its cash to speed up its build-out of manufacturing facilities. Here’s the Dow Jones Newswires story on what the CEO said yesterday; here’s a Webcast of the presentation.

Photo: Associated Press

A story in this morning’s WSJ cracks open what one government official calls a “secure system to protect these birds”: Secretive farms, classified as part of the nation’s “critical infrastructure,” where hens lay the hundreds of thousands of eggs needed to make swine-flu vaccine.

The article put us in mind of another big job for chickens seeking a career in public health: serving as a sentinel bird . It’s a job that requires some sacrifice, as this WSJ story suggested back in 2003:

Braving a burst of clucks and beating wings, a woman in a white Tyvek jumpsuit grabs a red-brown hen by the feet and holds it upside down until the flapping stops. Then she flips the bird over, tucks it between her knees, and pricks the hen’s comb with a tiny lancet, dabbing drops of blood onto a strip of filter paper to be tested for West Nile virus.

Sentinel birds got a lot of ink a few years back, when more than a dozen states established flocks as early warning systems for West Nile virus. See page 12 of these CDC gudelines for tips on setting up a sentinel flock.

Sentinel work isn’t limited to chickens; as Slate noted in 2006, flocks of ducks can serve as an early-warning system for the arrival of strains of bird flu.

Photo: Associated Press

New Jersey’s legislature passed a bill yesterday to legalize medical marijuana, and Gov. Jon Corzine has said he’ll sign it into law before leaving office next week.

Marijuana is now legal for some patients in more than a dozen states. But, at least based on the Jersey bill, the rules seem to be getting stricter as legalization spreads.

Medical marijuana will be limited to certain patients — people whose prognosis gives them less than a year to live, or those with specific symptoms resulting from certain diseases, such as AIDS, cancer and Crohn’s. (The bill also allows the state health department to add other diseases to the list.)

California — where doctors have wide latitude to prescribe marijuana for patients, and pot dispensaries have proliferated in some counties — seemed to serve as a cautionary tale for New Jersey.

Chris Christie, the Garden State’s Republican governor-elect (and former U.S. attorney) said medical marijuana in California is “completely out of control,” according to the Philadelphia Inquirer. Still, Christie said he supports “the idea of medical marijuana for seriously ill people for pain relief to them,” though he was wary of what he called “loopholes” in the bill, such as allowing the health department to expand the list of qualifying conditions.

Even the bill’s backers seemed as eager to talk up what the bill restricts as what it allows. “This bill recognizes that compassion for the sick and dying and adherence to our nation’s war on illegal drugs are not mutually exclusive ideals,” one state senator who sponsored the bill said in a statement.

Patients who qualify will be allowed to buy up to two ounces of marijuana a month at state-sponsored dispensaries, the WSJ says. Patients won’t be allowed to grow marijuana at home or to smoke in public, the New York Times notes.

The bill passed by a wide margin — 48-14 in the Assembly and 25-13 in the state Senate.

Photo: Getty Images

Here’s a quick drug-news roundup:

More than two-thirds of patients who took an experimental impotence drug were able to have sex within 15 minutes, according to Vivus, the company that’s developing the drug. (Among patients who took a placebo, the success rate within 15 minutes was less than one third, by the way.) Impotence drugs such as Pfizer’s Viagra and Eli Lilly’s Cialis can take hours to work, so faster onset could be a selling point, Dow Jones Newswires notes. Still, the company has yet to file for FDA approval of the drug, avanafil, and a decision from the FDA isn’t likely until next year. And Viagra will lose patent protection in 2012, which will bring generic competition to the field.

The FDA approved Actemra for rheumatoid arthritis patients who need more treatment after trying a drug like J&J’s Remicade or Abbott’s Humira. Those drugs block something called tumor necrosis factor; Actemra, sold by Roche, blocks another substance, interleukin-6.

Novartis started selling a new antipsychotic drug called Fanapt in the U.S. While this isn’t particularly surprising — the FDA approved the drug last year to treat schizophrenia — the backstory is interesting. According to the Washington Post, Novartis actually sold the rights to the drug a while back, to a company called Vanda that was founded by an MD — who used to work for Novartis. Last year, Novartis acquired the rights to sell Fanapt in the U.S. and Canada.

Photo: iStockphoto

More action today on how governments are dealing with falling demand for the H1N1 (swine) flu vaccine.

The U.S. cut its order from the Australian manufacturer CSL by more than half, to 14 million doses, Bloomberg reports. The U.S. is allowed to change the quantity of its order under its contract with CSL, a company spokeswoman told Bloomberg — though not all countries have similar terms in their contracts with the company. The U.S. placed orders with multiple manufacturers.

Meanwhile, the U.K. is trying to recoup some of the £500 million it spent ordering H1N1 vaccine from Baxter and GlaxoSmithKline, the Financial Times reports. The government initially ordered enough vaccine to cover the entire population. But the relatively mild nature of the pandemic, among other factors, has led to low demand.

Several other European countries are also canceling orders, as we noted last week. Besides the vaccine manufacturers we already mentioned, the cancellations may affect Sanofi-Aventis and Novartis.

Photo: iStockphoto

New York City said today that it’s joining with other cities to push restaurants and packaged food makers to cut the amount of salt they use by 25%.

Food companies have been really into making health claims on the front of their products lately. So you’d think that those who choose to go along with the NYC program (which is voluntary) might make a big deal about selling foods with less salt.

But a story in this morning’s WSJ points out that food makers have actually found that they do better when they cut salt without making a big deal about it.

“Once you start saying you’ve taken salt down, it’s basically equal to, ‘It’s not going to taste good,”‘ Unilever’s North American director of nutrition and health told the WSJ.

Campbell Soup cut the amount of sodium in a version of V8 juice by about a third over several years without announcing the shift, and ConAgra is in the process of making a similar reduction in the amount of sodium in Chef Boyardee.

Those reductions are part of a broader cuts some companies are making (though the amount of sodium in packaged foods isn’t declining overall, the WSJ says). ConAgra has said it will cut the amount of sodium in roughly 80% of its foods by 20%, and Sara Lee has also committed to cuts. Campbell says it has cut about a quarter of the sodium from its top selling products since 2001.

Extra Salt: For more on sodium and heart disease, check out this explainer from the CDC.

Photo: iStockphoto

Is a $3 million grant from Pfizer the answer to creating continuing medical education courses that are free of industry influence? Yes, according to Stanford’s med school.

In a statement this morning, Stanford said the three-year grant comes with “no conditions, and the company will not be involved in developing the curriculum.”

Drug companies, medical device makers and other health-care companies spend about $1 billion every year to sponsor the continuing medical education courses that doctors have to take to keep their licenses up to date. But as lawmakers, among others, have started to pay more attention to the financial ties between doctors and industry, there’s been a move to limit the industry’s influence on CME courses.

Stanford said back in 2008 that it would no longer accept industry financing from companies that wanted to fund specific CME courses. Also that year, Pfizer stopped funding CME provided by third-party, for-profit companies.

The new CME curriculum is being designed by Stanford docs and will aim to be more participatory and interactive than traditional lectures. The courses will take place on the Stanford campus.

This morning’s New York Times includes a report on the Stanford-Pfizer arrangement, with mixed comments from a few docs who have studied doctor-industry ties. One doc praised the move, saying Stanford “is once again leading the pack.” Another says the announcement that industry funding will lead to an independent curriculum is “self-satirizing.”

In the statement from Stanford, Pfizer’s chief medical officer says the company wants to “help redefine how CME is funded so that practicing physicians can get access to the latest science, presented in ways that unquestionably put the interests of the patient first and foremost.”

Photo: Associated Press

More people are waiting for organ transplants and dying on transplant waiting lists. So governments around the world are looking for new ways to encourage more people to be donors, and doctors are using organs that they might have rejected in the past.

Israel just launched a system where people who agree to be donors get higher priority if they ever need an organ; surgeons in Maryland recently transplanted kidneys from which they had excised tumors.

In an essay in this weekend’s WSJ, George Mason University Economist Alex Tabarrok cites these and other examples, and argues for new measures — including, perhaps, some form of compensation — to increase the supply of organs.

Another option is the “daisy chain” of live kidney donors. It’s unlikely to have as broad an impact as paying for organs, but it’s uncontroversial, and its use is already growing. Here’s how it works.

One person — call him Abe — wants to donate a kidney to Bob, but they’re not a good match. In the next town over, Carlos wants to donate a kidney to David. Also, alas, not a good match.

But, as it happens, Abe is a match for David, and Carlos is a match for Bob. So each donor can give his kidney to a stranger, in exchange for the knowledge that his own friend will get a kidney.

That basic model (known in its simplest form as paired donation) can be expanded to include lots of intermediaries — the full daisy chain — when a simple paired swap doesn’t suffice.

This kind of thing has been around for a while now, but it seems to be getting more common — and more complex — lately. A chain of 10 transplantations carried out over eight months was described last year in the New England Journal of Medicine. And late last year, doctors at two Washington hospitals did a chain of 13 transplants over six days.

Teva’s CEO said yesterday he expects his company’s revenues to double to $31 billion by 2015. The market apparently believed him: The company’s shares were up more than 3% in U.S. trading this afternoon, to a 52-week high.

Teva’s growth is the latest reminder of the way generic drugs and the companies that make them are changing the global pharma landscape. It’s no longer correct to think of generics manufacturers as scrappy little competitors nipping at the heels of big pharma.

Teva’s market cap is around $50 billion — bigger than Eli Lilly’s and comparable to Bristol-Myers Squibb’s. (Of course, Teva trades at a much higher multiple than either Bristol or Lilly.)

It’s not even right to think of Teva as a pure-play generics shop; a big chunk of its revenue comes from the patented multiple-sclerosis drug Copaxone, and the company plans to keep a sales mix of 70% generics and 30% branded drugs, Dow Jones Newswires reports. Other big generics companies are also working on branded drugs; Dr. Reddy’s of India said this week that an experimental diabetes drug it’s working on with a European partner reduced blood-sugar levels in a late-stage trial.

At the same time, branded drug makers are moving further into the generics business. Pfizer made a deal this week that adds to the list of off-patent drugs it’s selling in the U.S. GlaxoSmithKline has cut its own generics deals, Sanofi-Aventis has bought some generics makers outright and Merck recently set up a unit to sell generic copies of biotech drugs.

Google’s CEO Eric Schmidt doesn’t know why docs haven’t embraced databases to help them sort through medical information. Atul Gawande, the Harvard surgeon and New Yorker writer, suggested an explanation.

Gawande, who has a new book on the benefits of checklists, spoke yesterday to a meeting of a group that advises President Obama on science and technology. Schmidt is part of that group.

According to a blog post from the journal Science, Schmidt said:

So when you show up at the doctor with some set of symptoms, in my ideal world what would happen is that the doctor would type in the symptoms he or she also observes, and it would be matched against the data in this repository. Then this knowledge engine would use best practices, and all the knowledge in the world to give physicians some sort of standardized guidance. This is a generalized form of the checklists that you’re talking about …

As computer scientists, this is a platform database problem, and we do these very, very well, as a general rule. And it befuddles me why medicine hasn’t organized itself around these platform opportunities.

Gawande’s explanation, as quoted in the Science blog:

I think part of the bafflement occurs because the folks who know how to make such systems don’t understand how the clinical encounter actually operates.

In particular, Gawande said, a database is likely to return more information than a clinician could make sense of during a patient visit when there are “15 minutes to manage six problems.” Still, he added, the right kind of apps for “for your iPhone or whatever the new Google one is” (ouch!) could be useful for doctors.

This sort of discussion has been going on for years, but it has added urgency these days because over the next few years the federal government will pay doctors and hospitals tens of billions of dollars to start using electronic medical records.

At some point, an archived Webcast of yesterday’s panel meeting will be available here.

Image: iStockphoto

Paying donors of tissue or organs can help sick people by driving up supply. But creating a market for human parts is an ethically slippery proposition.

In this country, it’s legal to compensate donors of eggs, sperm and blood, but it’s illegal to pay organ donors. Compensating donors of bone marrow — which is sometimes removed from the bone itself, but more often taken from the donor’s blood — is also illegal. But a lawsuit in federal court is challenging that ban and seeking to launch a pilot compensation program.

Offering marrow donors scholarships or housing stipends could mean better outcomes for patients with diseases such as leukemia. And, since bone marrow grows back after it’s donated, it makes sense for the law to treat marrow donation more like blood or sperm donation rather than kidney donation, a doctor and a lawyer argue this morning on the New York Times op-ed page.

But the National Marrow Donor Program has argued that paying donors might compromise safety.

“Offering compensation to potential donors might compel them to withhold important personal health information that would negatively impact the patient,” the group said in a statement to American Medical News, which reported on the lawsuit last month. “The safety of the donors is equally important. Offering compensation to potential donors might also compel them to withhold personal health information that would normally defer them from donating.”

Health Blog Question of the Day: Should bone marrow donors be compensated?

Image: iStockphoto

A post today over at Pharmalot drew our attention to notices of job cuts that Merck and Pfizer had announced on a New Jersey government Web site.

Both companies have said they’ll cut thousands of jobs as part of the big mergers both completed last year, and these announcements account for a small fraction of those — 500 cuts for Merck, starting on Feb. 9, and 400 for Pfizer, starting on Jan. 31, according to the posting. Still, it seemed worth learning more, so we checked in with both companies.

The Merck announcement refers to cuts in the company’s U.S. sales organization, a Merck spokeswoman told the Health Blog. The cuts will actually exceed 500 people, and will include those who worked for both Merck and Schering-Plough before the merger. She also said the cuts apply to people who work both in New Jersey as well as other states. (Further reading: Our post from yesterday on what the CEO said about job cuts at the company)

The Pfizer announcement says the cuts are based in Monmouth Junction; a Pfizer spokeswoman told us that refers to the closure of the company’s Princeton R&D facility, which was announced last November. She also mentioned that Pfizer plans to maintain a significant presence in New Jersey, including facilities in Madison and Peapack.

Photos: Associated Press

A few months back, a group of scientists got a lot of attention when they published a study that suggested a virus called XMRV could be linked to many cases of chronic fatigue syndrome, or CFS.

But as we noted at the time, the study didn’t clearly prove a link between the disease and the virus. Now, in a study published this week in the journal PLoS One, scientists in the U.K. say they looked at samples from 186 CFS patients and found no sign of XMRV.

A research institute that was part of the earlier study fired off a press release that faulted the methods used in the new article, arguing that the techniques “not only explain their failure to replicate” the earlier findings, “but also render the conclusions meaningless.” Needless to say, the U.K. scientists defended their work. (For more on the technical back-and-forth, see this article from ScienceNOW.)

A lot is at stake here, because there’s no test to determine whether someone has CFS; it’s diagnosed based on a patient’s symptoms, which the CDC says include six months or more of incapacitating fatigue, along with other problems. So finding a physiological link — like a viral infection — would be an important advance.

Image: iStockphoto

Washington Dems are still grinding out a deal on the health-care bill; here’s coverage from the WSJ, New York Times and Los Angeles Times on yesterday’s meeting between congressional leaders and President Obama.

Meanwhile, the WSJ’s David Wessel writes today in his Capital column that Medicare Part D — the prescription drug program launched a few years back — offers some useful lessons for the current debate.

The program has shown that you can drive widespread coverage by enlisting private insurers to administer a public plan — something that sounds a lot like the insurance exchanges proposed under the health-care bills. But there are a few twists.

Under Medicare Part D, seniors choose from dozens of privately administered plans. Research shows that they don’t typically choose the one that’s the best deal for them, because they overrate the importance of premiums and underrate the importance of out-of-pocket spending. That’s a reminder that elaborate cost-sharing formulas aren’t always as efficient in the real world as economists might hope.

Widespread drug coverage has led seniors to use more prescription drugs. No surprise there, but it’s a reminder that increased health insurance coverage is likely to lead to more people seeking health care, which may strain the system. (Finding a doctor could be particularly tough for Medicaid patients, as we noted yesterday.)

One big surprise in the Medicare drug benefit: It’s been far cheaper than the CBO predicted. The initial price tag was $640 billion over 10 years, and now it’s down to $410 billion. That suggests that not everything in health care proves more expensive than expected. At the same time, plans to close the Medicare “doughnut hole” are a reminder that entitlements tend to expand over time, a former CBO chief told Wessel.

Image: iStockphoto

One morning last February, a bomb exploded in Trent Pierce’s driveway in West Memphis, Ark. Pierce, a family doc who chaired the state’s medical board, was severely burned and lost an eye.

Yesterday, a doctor named Randeep Mann — an internist who had been disciplined by the state medical board — was accused of planting the bomb. Here’s the grand-jury indictment, and here’s coverage from the Associated Press and the New York Times.

Investigators first talked to Mann at his house on the day of the explosion. He is a registered arms dealer, and he showed the investigators a grenade launcher, according to the feds. The next month, a canister of grenades was discovered buried in the woods a few hundred feet from Mann’s home. Investigators got a search warrant and found several similar canisters of grenades in Mann’s house, as well as multiple grenade launchers and more than 100 automatic and semi-automatic weapons.

“The majority” of the weapons were lawfully registered, the feds say, but not all of them, and the unregistered weapons led to charges against Mann. He has pleaded not guilty to those charges. The indictment yesterday adds the bombing charges; Mann’s attorney declined to comment on the new charges on Wednesday, the AP said.

The state board had stripped Mann of the right to prescribe narcotics in 2006 after 10 of his patients fatally overdosed. He argued that some of the patients overdosed on medications prescribed by other doctors, and in other cases he didn’t receive hospital reports of non-fatal overdoses suffered by his patients.

Photo of Pierce’s car after the bombing by Associated Press

Merck has said it will cut some 16,000 jobs as part of its merger with Schering-Plough. But a few months after the merger, it’s still not clear exactly where those jobs will come from. The company’s CEO, Dick Clark, shed a bit of light on the subject today.

Speaking at an event hosted by Goldman Sachs, Clark said Merck will “obviously eliminate some of the duplication” in the company’s sales force as part of the integration with Schering. He also suggested that the company will look at outsourcing some of its sales work, in order to be more flexible for product launches.

Clark also brought up manufacturing. Over the past several years, Merck went from 40 plants down to 25 plants — but after the merger, Merck now has 96 manufacturing plants, Clark said. “I think there’s an opportunity there, just off the top of my head,” he said.

And a little more: “There’s still a lot of duplication, not only in sales force, but in marketing organizations and corporate organizations, and issues like that,” he said. He also mentioned that “the number of research sites you need” is “something that has to be looked at.”

For more, you can sign in here to listen to an archived version of the talk.

Photo: Bloomberg News

The distance between Big Pharma and the generic drugs business keeps getting narrower. Under a deal with an Indian drugs shop Strides Arcolab, Pfizer will add some 40 off-patent drugs, including many cancer medicines, to the list of products it sells in the U.S. Here’s a statement Pfizer put out describing the deal.

Pfizer’s been moving in this direction for a while now. An “established products” division the company set up back in 2008 to focus on off-patent drugs now sells some 600 products, and the company has cut several deals like the one announced today. (See the 2008 deal with Aurobindo India, for example.)

Growth has slowed in the branded-drugs business, and the push is on in the developed world to slow the rise of health-care costs. Both of those factors are driving many of the big names in the drugs business to move further into generics. In the past few years, GlaxoSmithKline made a deal with the South African drug-maker Aspen to sell off-patent drugs in the developing world, Sanofi-Aventis bought several generics companies, and Merck set up a unit to sell copies of off-patent biotech drugs.

Photo: Associated Press

The health-care bills passed by both the House and the Senate would both expand Medicaid, the government insurance program for the poor. One important difference between the bills: The House version would significantly boost Medicaid payments to primary-care docs, while the Senate bill would not.

This difference — highlighted in this New Republic piece — isn’t on the short list of things everybody’s talking about as the Senate and House hash out a final bill. But it’s important for people with Medicaid and the doctors who treat them, as well as for the taxpayers who would have to fund higher Medicaid payments.

Medicaid typically pays significantly less than Medicare, which in turn tends to pay less than private insurance. As a result, lots of docs say they lose money when they treat Medicaid patients, and limit the number of Medicaid patients in their practice or refuse to take Medicaid altogether. That can make it tough for people with Medicaid to find care.

So on the one hand, the benefits of expanding Medicaid coverage to more people would be significantly diminished if those people couldn’t find a primary care doctor. On the other hand, bringing Medicaid payments for primary care up to parity with Medicare payments for the same services would cost $57 billion over 10 years, according to the CBO.

Health Blog Questions of the Day: Should Congress increase Medicaid payments for primary care? If so, where should the money come from?

Image: iStockphoto

For patients with mild depression, a couple popular antidepressants don’t work any better than placebos, according to a study in this week’s JAMA that mined data from previously published studies. Earlier analyses have come to similar conclusions.

The typical conclusion from studies like these is that antidepressants don’t work for mild to moderate depression. That’s fair by the rules of randomized trials; a drug has to work better than a placebo. But the data do suggest that patients with mild depression feel better when they take antidepressants — it’s just that they also feel better when they take placebos.

This graph (JAMA subscription required) from the study compares the benefit from a placebo with the benefit from an active drug, for patients ranging from mild to severe depression.

It suggests that both placebos and drugs help alleviate depression, and that the benefits of both placebos and drugs increase as the severity of the depression increases. As you move along the spectrum from mild to severe disease, the benefits of the active drug increase more than the benefits of the placebo. So for patients with severe depression, the active drug works significantly better than the placebo.

This study looked at two drugs — paroxetine (sold as Paxil by GlaxoSmithKline) and an older drug called imipramine. But a 2008 analysis published in PLoS looked at a wider range of antidepressants and reached similar conclusions.

A Glaxo spokeswoman told Bloomberg News that “the studies used for the analysis in the JAMA paper differ methodologically from studies used to support the approval of paroxetine for major depressive disorder, so it is difficult to make direct comparisons between the study results.” For more on the study, see coverage from Dow Jones Newswires and the New York Times.

Image: iStockphoto