Three days before Christmas, Emory University gave its long-time chief of psychiatry a nice holiday gift: in return for his stepping down as psychiatry head, university officials are allowing Charles Nemeroff to stay at the university as a full professor despite his failure to disclose hundreds of thousands of dollars in personal payments from GlaxoSmith Kline, the maker of Paxil. According to Pharmalot, Emory justified its milk-toast action by saying that a review of Nemeroff's speeches supported his contention that his lectures were not product-specific but rather limited to general medical topics such as depression and bipolar disorder.
Somehow I seriously doubt that. Why? Because over the years Nemeroff has most definitely given product-specific lectures on behalf of drug companies. As I note in Side Effects, Nemeroff spoke on behalf of Eli Lilly, the maker of Prozac, during the pivotal 1991 FDA hearing on concerns that Prozac increased the risk of sucidal thoughts and behaviors among patients taking the SSRI antidepressant. (At the time, Nemeroff had lucrative consulting arrangements with Eli Lilly and also owned stock in the Indianapolis-based drug company). As part of his presentation to the FDA, Nemeroff specifically talked about the available research on Prozac and other SSRI antidepressants (including Paxil) and went so far as to dismiss case reports then emerging about the suicidal risks of these drugs. According to people who attended that hearing, Nemeroff's "elegant" and very product-specific lecture that day helped convince the FDA advisory board to dismiss concerns about these drugs' side effects. As a result, it took the federal agency another 13 years to put black box warnings about the suicidal risks on Prozac, Paxil and other antidepressants.
In concluding its investigation (back story), Emory said it found no evidence that Nemeroff's consulting activities biased scientific research. It seems obvious that university officials weren't looking very hard.
For now, at least, the university will be keeping Nemeroff on a tight leash -- he has to get prior approval for any and all outside speaking and consulting engagements and is not allowed to be involved in any NIH-funded research for at least two years. By then, hopefully, Congress will have passed the Physician Payment Sunshine Act, so when Nemeroff does start doing research again on the taxpayer's dollar, his take from the drug companies will be a matter of public record.
Sunday, December 28, 2008
Thursday, December 18, 2008
Ghostwriting: an old and venerable practice
I'm delighted to see that The New York Times has discovered the problem of ghostwriting -- wherein drug companies pay shills to write medical journal articles and then go hunting for respected doctors to put their names on already prepared articles. And I can only applaud the work being done by Senator Charles Grassley's team that led to the Times' article Friday on the ghostwriting behind several journal articles promoting Wyeth's hormone replacement drug Prempro (even after a federal study found the drug raised the risk of breast cancer).
But let's not kid ourselves: ghostwriting by the pharmaceutical industry is neither new nor uncommon. The British psychiatrist and historian David Healy was among the first to write about this widespread practice, when he published a 2003 article in The British Journal of Psychiatry about Pfizer's ambitious ghost-writing efforts to promote its antidepressant, Zoloft, in numerous medical journals. Healy showed that, similar to what Wyeth did with Prempro, Pfizer ginned up a publication plan that indicated all of the studies it had going on Zoloft (sertraline), who the authors were, and what the status of publication for each article was. As Pfizer's plan indicated, most of these articles had originated with ghostwriters (in this case a company called Current Medical Directions) and a number of the planned articles listed the authors as "To Be Determined."
GlaxoSmithKline did the same thing in promoting its blockbuster antidepressant Paxil, as a number of books, my own included, have revealed. According to documents unsealed in a lawsuit, Glaxo hired a ghostwriter by the name of Sally Laden (from Scientific Therapeutics Inc.) to write the first draft of a study comparing Paxil to placebo and an older antidepressant in treating depression among adolescents. The study purported to show that Paxil was more effective than placebo and the older tricyclic, even though the actual data showed that the opposite was true; see back story. As the legal documents show, the principal researchers of study 329, as it became known, made only minimal changes to the ghost-written draft, and it was Laden who, with the help of Glaxo officials, shopped it to several journals, before finally getting the article published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001. Glaxo then used the JAACAP article to heavily market Paxil for pediatric use to doctors in the U.S. (even though such off-label marketing is supposed to be illegal).
Because of the publicity over such flagrant abuses, one former journal editor says that most leading journals now require the authors of submitted manuscripts to attest to the fact that they have written the paper's first draft or tell the journal who did write it. So while that may cut down to some extent on ghost writing, it doesn't mean the practice will disappear. After all, the journals still have to take the researchers' word for it. And that word, as has been demonstrated over and over again in the case of doctors on the take from drug companies, doesn't necessarily mean all that much.
But let's not kid ourselves: ghostwriting by the pharmaceutical industry is neither new nor uncommon. The British psychiatrist and historian David Healy was among the first to write about this widespread practice, when he published a 2003 article in The British Journal of Psychiatry about Pfizer's ambitious ghost-writing efforts to promote its antidepressant, Zoloft, in numerous medical journals. Healy showed that, similar to what Wyeth did with Prempro, Pfizer ginned up a publication plan that indicated all of the studies it had going on Zoloft (sertraline), who the authors were, and what the status of publication for each article was. As Pfizer's plan indicated, most of these articles had originated with ghostwriters (in this case a company called Current Medical Directions) and a number of the planned articles listed the authors as "To Be Determined."
GlaxoSmithKline did the same thing in promoting its blockbuster antidepressant Paxil, as a number of books, my own included, have revealed. According to documents unsealed in a lawsuit, Glaxo hired a ghostwriter by the name of Sally Laden (from Scientific Therapeutics Inc.) to write the first draft of a study comparing Paxil to placebo and an older antidepressant in treating depression among adolescents. The study purported to show that Paxil was more effective than placebo and the older tricyclic, even though the actual data showed that the opposite was true; see back story. As the legal documents show, the principal researchers of study 329, as it became known, made only minimal changes to the ghost-written draft, and it was Laden who, with the help of Glaxo officials, shopped it to several journals, before finally getting the article published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001. Glaxo then used the JAACAP article to heavily market Paxil for pediatric use to doctors in the U.S. (even though such off-label marketing is supposed to be illegal).
Because of the publicity over such flagrant abuses, one former journal editor says that most leading journals now require the authors of submitted manuscripts to attest to the fact that they have written the paper's first draft or tell the journal who did write it. So while that may cut down to some extent on ghost writing, it doesn't mean the practice will disappear. After all, the journals still have to take the researchers' word for it. And that word, as has been demonstrated over and over again in the case of doctors on the take from drug companies, doesn't necessarily mean all that much.
Thursday, December 11, 2008
Massachusetts officials allow huge loophole in new drug payment disclosure regulations
Kudos to The Boston Globe for revealing a big loophole in Massachusetts' new disclosure rules for health professionals: doctors who receive lucrative consulting and research funding from drug companies do not need to disclose these payments under the proposed regulations.
The new rules would require Massachusetts physicians from accepting free meals, gifts and vacation junkets from drug companies and mandate that they report any money they receive to promote drug company products. However, according to a memo from the Health and Human Services' deputy general counsel, the proposed regulations do not cover "bona fide services" for drug and medical device manufacturers such as consulting services, research, participation on advisory boards, company-sponsored presentations and education.
In other words, the disclosure requirements won't cover the kind of back-room payments to doctors that create the conflicts of interest that health advocates worry about most. As Tufts University professor Jerome Kassirer, author of On the Take: How Medicine's Complicity with Big Business can endanger your Health told The Boston Herald yesterday, "We shouldn't be hiding any kind of personal relationships between pharmaceutical companies and physicians, because of the possibility that any kind of money that goes to physicians could produce some sort of bias."
Not could, does. Research shows that doctors who receive personal payments from drug companies are much more likely to report and promote positive findings about the company's products than doctors who don't have these conflicts.
In a statement, Massachusetts Public Health Commissioner John Auerbach said the state's public health council allowed the loophole to keep clinical trials in the state. In other words, it caved into pressure from the drug and medical device companies.
It looks like we're going to have to wait for passage of the national Physician Payment Sunshine Act to get any kind of meaningful reform. That law, introduced by Sen. Chuck Grassely last year, would require companies to disclose any payment they made to health professionals in excess of $500 per year (back story). Unless, of course, Massachusetts citizens decide they've had enough and make their voices heard at the two public hearings being held on the new regs in January; see press release.
Wouldn't that be a hoot?
The new rules would require Massachusetts physicians from accepting free meals, gifts and vacation junkets from drug companies and mandate that they report any money they receive to promote drug company products. However, according to a memo from the Health and Human Services' deputy general counsel, the proposed regulations do not cover "bona fide services" for drug and medical device manufacturers such as consulting services, research, participation on advisory boards, company-sponsored presentations and education.
In other words, the disclosure requirements won't cover the kind of back-room payments to doctors that create the conflicts of interest that health advocates worry about most. As Tufts University professor Jerome Kassirer, author of On the Take: How Medicine's Complicity with Big Business can endanger your Health told The Boston Herald yesterday, "We shouldn't be hiding any kind of personal relationships between pharmaceutical companies and physicians, because of the possibility that any kind of money that goes to physicians could produce some sort of bias."
Not could, does. Research shows that doctors who receive personal payments from drug companies are much more likely to report and promote positive findings about the company's products than doctors who don't have these conflicts.
In a statement, Massachusetts Public Health Commissioner John Auerbach said the state's public health council allowed the loophole to keep clinical trials in the state. In other words, it caved into pressure from the drug and medical device companies.
It looks like we're going to have to wait for passage of the national Physician Payment Sunshine Act to get any kind of meaningful reform. That law, introduced by Sen. Chuck Grassely last year, would require companies to disclose any payment they made to health professionals in excess of $500 per year (back story). Unless, of course, Massachusetts citizens decide they've had enough and make their voices heard at the two public hearings being held on the new regs in January; see press release.
Wouldn't that be a hoot?
Wednesday, December 3, 2008
New study confirms: bias in the publication of drug trials is widespread
In its landmark lawsuit against GlaxoSmithKline, the New York State Attorney General accused the pharmaceutical giant of consumer fraud for not publishing negative findings about its antidepressant, Paxil, in essence, for not giving doctors and consumers the full story about its blockbuster drug.
Now comes a new study showing that the practice of selectively publishing only positive results and suppressing negative findings is an industry-wide habit. In a study published last week in PLoS Medicine, researchers at the University of California San Francisco discovered that only three-quarters of the randomized drug trials submitted for New Drug Applications (NDAs) between 2001 and 2002 were eventually published. Even more worrisome, trials with favorable outcomes were nearly five times more likely to be published than those with negative outcomes.
Furthermore, the researchers found evidence that primary outcomes were changed between the time the results were submitted to the FDA as NDAs and the time the studies were published. And when that happened, the results were invariably altered to favor the test drug, the researchers found.
These findings demonstrate that "the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased," the UCSF researchers conclude.
In an accompanying editorial, a scientist for the Mayo Clinic who previously worked with the World Health Organization's International Clinical Trials Registry Platform, agreed that the "trial literature is biased" and declared that the "the time has come to tackle the challenge of making key trial documents public."
Fortunately, drug companies are now required by law to post the results of all their clinical trials, negative as well as positive, on a publicly available website. And the fact that the leading medical journals now require pretrial registration -- i.e. researchers must post their trial protocols on a public website -- should help cut down on the tendency to change primary outcome measures to favor drug results.
However, drug company-sponsored researchers still don't have to publish the results of all randomized drug trials in medical journals. And since that is where doctors and consumers get most of their information, the full story about the safety and effectiveness of new drugs remains untold.
Now comes a new study showing that the practice of selectively publishing only positive results and suppressing negative findings is an industry-wide habit. In a study published last week in PLoS Medicine, researchers at the University of California San Francisco discovered that only three-quarters of the randomized drug trials submitted for New Drug Applications (NDAs) between 2001 and 2002 were eventually published. Even more worrisome, trials with favorable outcomes were nearly five times more likely to be published than those with negative outcomes.
Furthermore, the researchers found evidence that primary outcomes were changed between the time the results were submitted to the FDA as NDAs and the time the studies were published. And when that happened, the results were invariably altered to favor the test drug, the researchers found.
These findings demonstrate that "the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased," the UCSF researchers conclude.
In an accompanying editorial, a scientist for the Mayo Clinic who previously worked with the World Health Organization's International Clinical Trials Registry Platform, agreed that the "trial literature is biased" and declared that the "the time has come to tackle the challenge of making key trial documents public."
Fortunately, drug companies are now required by law to post the results of all their clinical trials, negative as well as positive, on a publicly available website. And the fact that the leading medical journals now require pretrial registration -- i.e. researchers must post their trial protocols on a public website -- should help cut down on the tendency to change primary outcome measures to favor drug results.
However, drug company-sponsored researchers still don't have to publish the results of all randomized drug trials in medical journals. And since that is where doctors and consumers get most of their information, the full story about the safety and effectiveness of new drugs remains untold.
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