Monday, September 28, 2009

Birds of a feather at Brown University party for Martin Keller

A festschrift is defined by Wikipedia as "a book honoring a respected person, especially an academic, and presented during his or her lifetime," usually on the occasion of the honoree's retirement. offers much the same definition for this term of German origin.

So it comes as bit of a surprise to see that Brown University's School of Medicine is throwing a festschrift of sorts on October 8 to honor none other than Martin Keller, the former chief of psychiatry at Brown who is being investigated by the Senate Finance Committee for failing to disclose major conflicts of interest. As I've reported in Side Effects and my blog here and here, Keller not only failed to disclose the millions of dollars he received over the years from companies whose drugs he was studying and promoting in medical journals and at conferences. But there is evidence that Keller and his co-authors misrepresented data in a clinical trial of Paxil to make the antidepressant look safer and more effective than it really was. This trial, known as study 329 and funded by GlaxoSmithKline, was published in 2001 and used by the drug company to heavily market Paxil for off-label use in children and adolescents.

The festschrift for Keller at Brown's Butler campus will feature a talk by none other than Alan Schatzberg, another disgraced former psychiatry chief (of Stanford) who, like Keller, stepped down after extensive publicity about his own conflicts of interest. What got Schatzberg into trouble was his failure to properly disclose the millions of dollars in stock he owned in a company whose drug he was studying and promoting; for more detail, see here.

Also presiding at the festschrift is Robert Hirschfeld, the chief of psychiatry at Texas Medical Branch at Galveston, which has had its own share of bad publicity (see here); and Lewis Judd, a former director of the National Institute of Mental Health, the federal agency that threw so much research money Keller's way over the years despite his blatant conflicts of interest and the evidence of scientific misconduct.

All of which raises a number of questions in my mind. Why at a time of university budget cutbacks, is Brown spending good money to throw a party for Keller? And does he really fit the definition of a respected academic? I'll leave that to you to decide.

All I can conclude is: birds of a feather do flock together.

Why medical researchers often fail to disclose conflicts of interest

In response to the recent storm of publicity over the failure of many medical researchers to disclose the lucrative personal payments they get from the drug and medical device companies that also fund their research, many medical journals have developed written policies requiring disclosure of such conflicts of interest. That's the good news. The bad news is that many of these new policies lack the kind of scope and specificity that would really make a difference.

That at least is the conclusion of a rigorous new study, published online in the journal Accountability in Research, which found that more than 75 percent of the 227 medical and toxicology journals studied had minimal levels of specificity in their written conflict of interest policies. For example, most journals do not specify what they mean by a conflict of interest, so it's up to the researcher-author to decide if, say, the consulting gig they have with a drug company that is also funding their research, poses a conflict of interest or not.

"People have very different ideas about what constitutes a conflict of interest and what doesn't, so that gives authors a lot of latitude not to disclose," said Tufts University professor Sheldon Krimsky, who is the lead author of the new study.

Likewise, most of the journals did not specify what type of content researchers need to disclose conflicts of interest for. Whether, for example, they are required to disclose when they were submitting an original article, or a review or commentary article. And very few journals provided a monetary threshold for when disclosure is a must.

As a result of such lack of specificity, many researchers make their own decisions about when and what they should disclose. Such findings may explain why previous studies have found big gaps and inconsistencies in who discloses what to medical journals.

"This explains why many researchers disregard the requirement and simply don't report conflicts of interest," Krimsky said.

As a typical example, Krimsky cites the written COI policy of the International Journal of Cancer Research, which merely states: "Authors must include financial support received for research. Acknowledgements for financial support must be stated." The policy says nothing about consulting or speaking gigs. Nor does it specify what kind of financial support it's referring to or for what type of submissions the authors should disclose this support.

The solution? Journals have got to got more specific in what they mean by conflicts of interest and when authors should disclose these conflicts. As Krimsky notes, "Journals have to take responsibility for what is not being reported and should be reported."

The American public (who funds much of this research) deserves no less.

Monday, September 21, 2009

Obama's OSHA pick under fire from right wing

Over the years, David Michaels, the George Washington epidemiologist who is President Obama's pick to head OSHA, has developed a reputation as a fair-minded proponent of using the best available science to protect workers and the environment. As Effect Measure points out, Michaels has made important scientific contributions in the area of popcorn workers lung and beryllium poisoning. He has also championed the cause of workers who became ill after working in nuclear weapons programs, and he has pushed for transparency in the disclosure of conflicts of interest among scientists taking money from chemical and drug manufacturers.

So it should come as no surprise to hear that these corporations and their rightwing attack dogs are trying to scuttle Michaels' nomination with typically outrageous smears. In one of the least egregious examples, a recent editorial in The Washington Times accused Michaels of being "virulently anti-business" and "an anti-gun zealot." What someone's position on guns has to do with an agency that is supposed to protect people in the workplace, I don't know. (While there's no question that better gun control laws would protect workers from colleagues who go postal, such legislation would certainly not be coming out of OSHA).

The Times editorial goes on to say that if appointed to OSHA, Michaels would be overly aggressive in enforcing workplace safety regulations. As far as I'm concerned, that sounds like an endorsement for the guy.

But don't take my word for it. Michaels deserves the appointment for a host of reasons (beyond the ones mentioned above). To begin with, he already has executive branch experience, having served as Assistant Secretary for Environment, Safety and Health at the Department of Energy in the Clinton years.

In 2006, Michaels received the American Association for the Advancement of Science's Scientific Freedom and Responsibility Award for his "commitment to obtain justice for workers whose health suffered from working in nuclear weapons programs, and for advocating scientific integrity in public policy making." And in November, Sigma Xi, the Scientific Research Society, will give him the John P. McGovern Science and Society Award.

Full disclosure: David Michaels invited me to speak to George Washington's School of Public Health while I was on my book tour for Side Effects. But that's not why I'm writing this blog. Michaels' scientific credentials and his record of championing people harmed in the workplace speaks for themselves.

Monday, September 14, 2009

Why doctors are still "crazy" about antidepressants

I just received a wrenching email from a woman in North Carolina who was prescribed a SSRI antidepressant because she was having trouble eating due to a "horrible metallic taste" in her mouth. After her blood work came back negative, her doctor decided the problem must be "emotional" and prescribed the antidepressant. Now I'm not a doctor, but I know from personal experience that a metallic taste can be caused by any number of things, such as a reaction to surgery or another drug. Why this lady's doctor would automatically link a bad taste in her mouth to depression is beyond me. Perhaps he decided that her real problem was anxiety and that an SSRI might ease that, I don't know.

What I do know is that an inordinate number of women continue to be given antidepressants at the drop of a hat, as I've written about here. And indeed, the North Carolina woman writes:

I know so many women on SSRI antidepressants that it's mind boggling! I hear friends talk about how they "need a little something" because they are feeling stressed out so they go to the doc and get a prescription.

Of course, this problem of overmedication is not limited to SSRI antidepressants or women, for that matter. As Philip Dawdy notes in Furious Seasons, 60 percent of antipsychotics prescribed in the VA system in 2007 were prescribed off-label for conditions such as post-traumatic stress disorder, depression and anxiety. This disturbing data comes from a new study in Psychiatric Services, in which the authors themselves conclude:

Given that these drugs are expensive, have potentially severe side effects, and have limited evidence supporting their effectiveness for off-label usage, they should be used with greater caution.

So why do so many doctors continue to prescribe such potent psychoactive drugs with limited efficacy and potentially dangerous side effects? Or as the North Carolina woman put it, why are so many doctors still "crazy about the SSRIs?" It all comes back to the aggressive marketing of these drugs by the drug industry and the reality that so many key opinion leaders in psychiatry are on the pharm companies' dole. It also has a lot to do with the fact that an astonishing percentage of studies published in supposedly reputable medical journals are ghost-written, usually by paid writers for the drug industry. For example, as much as 10.9 percent of studies published in the prestigious New England Journal of Medicine were ghost-written, according to a new study released at an international meeting of journal editors in Vancouver and first reported in The New York Times.

This kind of disclosure doesn't inspire much confidence in the way doctors get their medical information, does it?

This latest wrinkle on ghostwriting didn't, of course, make much difference to my North Carolina pen pal; she had already taken matters into her own hands. After imbibing the prescribed antidepressant for a week and experiencing some weird side effects -- bad mood swings and shaking -- she went off the drug and is now working with her doctor to find another way to deal with her symptoms. Getting off the SSRI is a good start.

Tuesday, September 8, 2009

Side Effects wins NASW Science in Society Award

Forgive me for tooting my own horn but this is such a great honor I had to post the news: Side Effects has been named a winner of the 2009 NASW Science in Society Awards. Here's an excerpt from the official press release:

The winners of the 2009 Science in Society Journalism Awards, sponsored by the National Association of Science Writers, are: Alison Bass for her book Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial (Algonquin Books); Jason Felch and Maura Dolan for their Los Angeles Times series, "Genes as Evidence"; Michael J. Berens and Ken Armstrong for their Seattle Times series "Culture of Resistance"; and Pamela Ronald for her commentary "The New Organic," which appeared on, the web site of the Boston Globe.

NASW established the Science in Society awards to provide recognition -- without subsidy from any professional or commercial interest -- for investigative or interpretive reporting about the sciences and their impact for good and bad. The awards are intended to encourage critical, probing work that would not receive an award from an interest group. Beginning with the first award in 1972, NASW has highlighted innovative reporting that goes well beyond the research findings and considers the associated ethical problems and social effects. The awards are especially prestigious because they are judged by accomplished peers. NASW currently awards prizes in four categories: books, science reporting, science reporting with a local or regional focus, and commentary or opinion.

* In Side Effects, Alison Bass, an investigative journalist who has covered medicine, science, and technology for The Boston Globe and other publications, tells the story of how pharmaceutical giant GlaxoSmithKline systematically misled physicians and consumers about the safety and efficacy of Paxil, a popular antidepressant. "It's a very complicated issue, and the author conveyed this like a mystery story," said one of the judges, noting that, "Her investigations led to changes in policy in many areas of public health, not only nationally but internationally."

The four winners each will receive a cash prize of $2,500 at a reception on October 18, 2009 during NASW's ScienceWriters2009 meeting and workshop, which this year will be in Austin, Texas.

Thursday, September 3, 2009

Pfizer's $2.3 billion fine is only the tip of the iceberg

When I was writing Side Effects, I learned that the New York State Attorney General's office had sued Pfizer for the illegal off-label marketing of Bextra, its Cox-2 painkiller. (If you'll recall, Bextra, like Vioxx, was withdrawn from the market because of evidence that it increased the risk of heart failure in patients). Sources at the AG's office told me that other prosecutors were also going after Pfizer for its deceptive marketing tactics and asked me to keep this information under my hat for the time being.

If you read today's New York Times or Washington Post, you'll see that these legal actions have culminated in a record $2.3 billion fine against Pfizer for the illegal marketing not only of Bextra but of three other drugs as well. As The Washington Post reports:

The Pfizer unit Pharmacia & Upjohn pleaded guilty to a single felony charge that accused the company of marketing its anti-inflammatory drug Bextra for broader uses and higher dosages than those approved by the Food and Drug Administration.

The company allegedly enticed doctors to prescribe the drug for pain relief by taking them on lavish trips, created sham requests for medical information as an excuse to send unsolicited advertising materials to physicians, and drafted articles promoting the pills without disclosing its role in preparing the stories.

In connection with the settlement, Pharmacia & Upjohn consented to pay $1.3 billion in fines and forfeiture, the biggest criminal penalty ever imposed in the United States, prosecutors said. Pfizer paid an additional $1 billion to state and federal authorities to resolve civil allegations of improper marketing over Bextra and three more drugs: Geodon, an antipsychotic medicine; Zyvox, an antibiotic; and Lyrica, an epilepsy medicine.

This is Pfizer's fourth settlement for illegal marketing activities since 2002 and prosecutors said they factored that "recidivism" into the steep penalty announced yesterday. Yet, as Gardiner Harris in The New York Times notes, the $2.3 billion penalty amounts to less than three weeks of Pfizer's sales.

Deja vu, anyone? A few days ago, Forest Labs was in the news for spending lots of money on doctors in medical conferences, consulting fees, junkets and free meals to convince them that the antidepressant Lexapro was much better than its off-patient antidepressant Celexa (even though the chemical make-up of the two drugs are nearly identical). And now we have Pfizer dunned for doing much the same thing with several of its blockbuster drugs.

It's good to see the Obama administration and various states getting serious about such health care fraud. But it's not enough to fine drug companies for deceptive and illegal marketing tactics. There has to be real reform in the medical research establishment. Until universities and doctors stop taking money that taints their scientific judgment and refrain from putting their names on papers they didn't write, how can the American public trust any health professional when it comes to the safety and effectiveness of prescribed drugs?