It looks as if the Food and Drug Administration is not the only federal agency in need of a Congress-initiated overhaul. The same Congressmen who recently vowed to strengthen the FDA's ability to levy fines against drug companies, order drug recalls and restrict drug industry advertising, according to The Wall Street Journal, are also investigating the failure of the National Institutes of Health (NIH) to monitor and take action against serious conflicts of interest among doctors who receive NIH funding for their research. Sen. Chuck Grassley, the ranking Republican on the Senate Finance Committee, recently issued a call for the NIH to revoke grants to academic scientists who fail to report financial conflicts of interest, according to The Chronicle of Higher Education.
The controversy attracting the most attention of late involves Dr. Alan Schatzberg, chair of psychiatry at Stanford University, who owns about $6 milion in stock in a company whose drug he is also studying. According to recent postings on Pharmalot and Health Care Renewal, Schatzberg failed to fully disclose the extent of his holdings in Corcept Therapeutics to either Stanford University or the NIH, which has been funding research by Schatzberg into the use of Corcept's drug, mifepristone (RU-486) for treating psychotic depression. While Stanford has defended its management of Schatzberg's conflict of interest by saying that the psychiatrist "has not been involved in managing or conducting any human subject research involving mifepristone," Dr. Bernard Carroll, writing in Health Care Renewal, points out that Schatzberg is the principal investigator of the mifepristone depression study and recently published a review extolling the effectiveness of the drug in treating depression. As Carroll says, "So here we have an NIH-funded principal investigator, with a clear conflict of interest, who supposedly remains at arm's length from the project, accessing the primary data files, running a new analysis himself, and publishing an exaggerated new efficacy result for his drug..."
Schatzberg, who is president-elect of the American Psychiatric Association, is also a buddy and long-time colleague of Dr. Martin Keller, the chief of psychiatry at Brown University, whose own conflicts of interest I expose in Side Effects: A Prosecutor, a Whistleblower and a Best-selling Antidepressant on Trial. Just like Schatzberg, Keller failed to fully disclose the extent of his financial conflicts to the NIH, which has awarded him millions of dollars in funding for research on depression. When I first wrote about Keller's conflicts in 1999 for The Boston Globe, the NIH said they would look into the matter. NIH officials took no action against Keller and now the question is: will the agency be similarly passive in the Schatzberg affair, even though its own grant policy from 1995 requires universities to disclose and avoid such financial conflicts? And will Congress step in if the NIH doesn't? Let's hope so.
Thursday, July 31, 2008
Wednesday, July 23, 2008
The conflicts go on and on and on...
Health Affairs bills itself as "the number one cited health policy journal devoted to publishing original, peer-reviewed research and commentary." Judging by the journal's review of my book, Side Effects, its commentary may be original but it sure isn't unbiased. To review the book, Health Affairs turned to none other than Dr. Alan J. Gelenberg, a psychiatrist who is a long-time friend and collaborator of Dr. Martin Keller, the chief of psychiatry at Brown University whose financial ties to the drug industry I expose in my book. See Gelenberg's review here.
As a quick search of Medline reveals, Gelenberg, a professor of psychiatry at the University of Wisconsin, and Keller collaborated on at least 20 papers dating back to1989 and up to last year. Most of these studies involve the very antidepressants I write about in my book. Indeed, Gelenberg was a co-author with Keller on a notorious paper published in 1998 on the antidepressant Serzone, which occasioned an accompanying editorial by the editor of The New England Journal of Medicine titled "Is Academic Medicine for Sale?" because there were so many conflicts of interest between the researchers of this paper (Gelenberg and Keller included) and the pharmaceutical industry.
As Roy Poses points out in his Health Care Renewal blog, Gelenberg is a consultant to GlaxoSmithKline, the maker of Paxil (the bestselling antidepressant in the title of my book), Eli Lilly, Pfizer, Wyeth, Novartis and Forest Labs, all makers of other antidepressants. As for Serzone, it was pulled from the U.S. market in 2003 after it was found to cause liver damage and deaths in a number of patients.
Interestingly enough, on many of the studies that Keller and Gelenberg collaborated, a third author was none other than Dr. Alan Schatzberg, the head of psychiatry at Stanford University, who, like Keller, is currently being investigated by Sen. Chuck Grassley's Finance committee for his financial ties to the drug industry. See my July 4 blog.
Not surprisingly, Gelenberg failed to disclose these myriad conflicts of interest at the end of his review for Health Affairs. So the questions remain: did he disclose them to the editors of Health Affairs and what, if any, effort did they make to ensure that their reviewer was an unbiased source?
As a quick search of Medline reveals, Gelenberg, a professor of psychiatry at the University of Wisconsin, and Keller collaborated on at least 20 papers dating back to1989 and up to last year. Most of these studies involve the very antidepressants I write about in my book. Indeed, Gelenberg was a co-author with Keller on a notorious paper published in 1998 on the antidepressant Serzone, which occasioned an accompanying editorial by the editor of The New England Journal of Medicine titled "Is Academic Medicine for Sale?" because there were so many conflicts of interest between the researchers of this paper (Gelenberg and Keller included) and the pharmaceutical industry.
As Roy Poses points out in his Health Care Renewal blog, Gelenberg is a consultant to GlaxoSmithKline, the maker of Paxil (the bestselling antidepressant in the title of my book), Eli Lilly, Pfizer, Wyeth, Novartis and Forest Labs, all makers of other antidepressants. As for Serzone, it was pulled from the U.S. market in 2003 after it was found to cause liver damage and deaths in a number of patients.
Interestingly enough, on many of the studies that Keller and Gelenberg collaborated, a third author was none other than Dr. Alan Schatzberg, the head of psychiatry at Stanford University, who, like Keller, is currently being investigated by Sen. Chuck Grassley's Finance committee for his financial ties to the drug industry. See my July 4 blog.
Not surprisingly, Gelenberg failed to disclose these myriad conflicts of interest at the end of his review for Health Affairs. So the questions remain: did he disclose them to the editors of Health Affairs and what, if any, effort did they make to ensure that their reviewer was an unbiased source?
Sunday, July 20, 2008
The story behind the story
A few weeks ago, The Wall Street Journal reported that Sen. Chuck Grassley (R-Iowa) had asked the FDA to re-examine data it had received from GlaxoSmithKline (GSK) way back in 1989 when the drug company first applied for approval of its antidepressant, Paxil. Grassley alleged that GSK had misrepresented data in a study comparing the use of Paxil with placebo in treating adults with depression. See my June 15 blog, Drug company under fire for Paxil research.
In his June 12 letter to the FDA, Grassley also noted that this past spring, the British Medicine and Healthcare Products Regulatory Agency, FDA’s counterpart in the U.K., concluded that GlaxoSmithKline knew of Paxil’s increased suicidal risk in adolescents as far back as the 1990s but hid that information from physicians and consumers. I reach much the same conclusions in my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepresssant on Trial.
The attorney who reviewed my book for The Wall Street Journal must not have read about these new developments. Or perhaps he did but chose to overlook them. Indeed, there is much that Mark Hermann, an attorney who defends drug companies in product liability cases, overlooked or got flat wrong in his review, according to Dr. Roy Poses, a doctor affiliated with Brown University, who critiqued Hermann’s review in his latest Health Care Renewal blog. To the many fine points that Dr. Poses makes may I add that the point of my book is not that the drug industry funded the clinical trials of antidepressants, but that industry money paid for Paxil studies that are now being attacked as highly questionable in numerous quarters.
While some might argue that Hermann was only doing his job – after all, he gets paid to represent drug companies – the more salient question is: could The Wall Street Journal have found no one with a slightly less blaring conflict of interest to review my book? Surely, New York's bastion of business news can do better than this.
In his June 12 letter to the FDA, Grassley also noted that this past spring, the British Medicine and Healthcare Products Regulatory Agency, FDA’s counterpart in the U.K., concluded that GlaxoSmithKline knew of Paxil’s increased suicidal risk in adolescents as far back as the 1990s but hid that information from physicians and consumers. I reach much the same conclusions in my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepresssant on Trial.
The attorney who reviewed my book for The Wall Street Journal must not have read about these new developments. Or perhaps he did but chose to overlook them. Indeed, there is much that Mark Hermann, an attorney who defends drug companies in product liability cases, overlooked or got flat wrong in his review, according to Dr. Roy Poses, a doctor affiliated with Brown University, who critiqued Hermann’s review in his latest Health Care Renewal blog. To the many fine points that Dr. Poses makes may I add that the point of my book is not that the drug industry funded the clinical trials of antidepressants, but that industry money paid for Paxil studies that are now being attacked as highly questionable in numerous quarters.
While some might argue that Hermann was only doing his job – after all, he gets paid to represent drug companies – the more salient question is: could The Wall Street Journal have found no one with a slightly less blaring conflict of interest to review my book? Surely, New York's bastion of business news can do better than this.
Monday, July 14, 2008
The Ties that Bind (Continued)
Senator Charles Grassley (R-Iowa) is now investigating Martin Keller, chief of psychiatry and the subject of my book,Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, according to Pharmalot.
I first wrote about Keller in a 1996 page-one article for The Boston Globe, revealing that his department at Brown had received hundreds of thousands of dollars from the Massachusetts Department of Mental Health for research that apparently wasn't being conducted. (Brown eventually returned more than $300,000 to Massachusetts state officials after they threatened to sue the university). In 1999, I published the news in The Boston Globe that Keller was earning hundreds of thousands of dollars from the very drug companies whose drugs he was studying and touting in medical journals.
My new book, Side Effects, chronicles the story of two women -- a prosecutor and a whistleblower -- who exposed the deception behind the making of the bestselling drug, Paxil. As it turns out, Keller was the principal investigator of a controversial study that was widely used to promote Paxil as safe and effective in adolescents. However, as Rose Firestein, a prosecutor for the New York State Attorney General's office, discovered, the actual data in this clinical trial showed that Paxil was no more effective than placebo in treating depression in adolescents and had far more severe side effects than the placebo did. Indeed, this particular study was one of three cited by the New York Attorney General in its landmark lawsuit accusing GlaxoSmithKline, the maker of Paxil, of “repeated and persistent fraud” in deceiving physicians and consumers about the safety and effectiveness of Paxil.
As Side Effects reveals, there is also evidence that Keller and his co-researchers misrepresented the data to make Paxil look safer than it really was. When I was researching the book, Brown said it was standing behind Keller and "the scientific integrity" of his research. Now that Congress is pointing its high beams at Brown's chief of psychiatry, I wonder if the university's tune will, finally, change.
I first wrote about Keller in a 1996 page-one article for The Boston Globe, revealing that his department at Brown had received hundreds of thousands of dollars from the Massachusetts Department of Mental Health for research that apparently wasn't being conducted. (Brown eventually returned more than $300,000 to Massachusetts state officials after they threatened to sue the university). In 1999, I published the news in The Boston Globe that Keller was earning hundreds of thousands of dollars from the very drug companies whose drugs he was studying and touting in medical journals.
My new book, Side Effects, chronicles the story of two women -- a prosecutor and a whistleblower -- who exposed the deception behind the making of the bestselling drug, Paxil. As it turns out, Keller was the principal investigator of a controversial study that was widely used to promote Paxil as safe and effective in adolescents. However, as Rose Firestein, a prosecutor for the New York State Attorney General's office, discovered, the actual data in this clinical trial showed that Paxil was no more effective than placebo in treating depression in adolescents and had far more severe side effects than the placebo did. Indeed, this particular study was one of three cited by the New York Attorney General in its landmark lawsuit accusing GlaxoSmithKline, the maker of Paxil, of “repeated and persistent fraud” in deceiving physicians and consumers about the safety and effectiveness of Paxil.
As Side Effects reveals, there is also evidence that Keller and his co-researchers misrepresented the data to make Paxil look safer than it really was. When I was researching the book, Brown said it was standing behind Keller and "the scientific integrity" of his research. Now that Congress is pointing its high beams at Brown's chief of psychiatry, I wonder if the university's tune will, finally, change.
The Ties that Bind…and Corrupt
In recent months, Senator Charles Grassley (R-Iowa) has shone a spotlight on the hundreds of thousands, in some cases, millions of dollars that drug companies have paid in speaking and consulting fees to prominent psychiatrists who failed to fully disclose these conflicts. Now, Grassley, a ranking member of the Senate Finance Committee, has widened his probe, investigating the American Psychiatric Association’s financial dealings with the pharmaceutical industry, according to Pharmalot and The New York Times.
As I reveal in my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, the APA has long had a cozy and mutually beneficial relationship with the drug industry. Beginning in the 1990s and continuing to the present, drug companies have paid the psychiatry profession’s trade association millions of dollars to sponsor industry symposiums at the APA’s well-attended annual meeting each year. In Side Effects, I follow the trail of money that led to one such industry symposium, which was sponsored by a large pharmaceutical company whose hot new antidepressant was being studied and touted by the same psychiatrists it was paying to speak at this APA affair. The moderator of the talk was none other than Dr. Alan Schatzberg, president-elect of the APA, who is himself under investigation for his financial conflicts of interest; see
my July 4 blog.
Also chronicled in my book are the longstanding financial ties between the drug industry and the National Alliance for the Mentally Ill (NAMI), the most powerful advocacy group for people with mental illness in the U.S. Not only do drug companies contribute millions of dollars to NAMI’s coffers every year, but as I reveal in Side Effects, Jim McNulty, the president of NAMI from 2002 to 2004, was earning thousands of dollars in speaking fees from the very companies who made the antidepressants he was talking up in lectures around the country. Yet NAMI members had no idea that McNulty was anything other than an unbiased patient advocate, because he never bothered to disclose these conflicts.
Given such a sorry record of collusion, it’s nice to see Congress, at long last, looking into the dark dank corners of drug research.
As I reveal in my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, the APA has long had a cozy and mutually beneficial relationship with the drug industry. Beginning in the 1990s and continuing to the present, drug companies have paid the psychiatry profession’s trade association millions of dollars to sponsor industry symposiums at the APA’s well-attended annual meeting each year. In Side Effects, I follow the trail of money that led to one such industry symposium, which was sponsored by a large pharmaceutical company whose hot new antidepressant was being studied and touted by the same psychiatrists it was paying to speak at this APA affair. The moderator of the talk was none other than Dr. Alan Schatzberg, president-elect of the APA, who is himself under investigation for his financial conflicts of interest; see
my July 4 blog.
Also chronicled in my book are the longstanding financial ties between the drug industry and the National Alliance for the Mentally Ill (NAMI), the most powerful advocacy group for people with mental illness in the U.S. Not only do drug companies contribute millions of dollars to NAMI’s coffers every year, but as I reveal in Side Effects, Jim McNulty, the president of NAMI from 2002 to 2004, was earning thousands of dollars in speaking fees from the very companies who made the antidepressants he was talking up in lectures around the country. Yet NAMI members had no idea that McNulty was anything other than an unbiased patient advocate, because he never bothered to disclose these conflicts.
Given such a sorry record of collusion, it’s nice to see Congress, at long last, looking into the dark dank corners of drug research.
Friday, July 4, 2008
Doctors under the Influence
Doctors on the take to drug companies seem to be dominating the news of late. Business Week recently chronicled the case of two doctors who touted the long-term use of Chantix and other prescription drugs to curb tobacco cravings in an Annals of Internal Medicine article. Turns out both doctors were being paid for speaking and consulting by the makers of these smoking cessation drugs, among them Pfizer, which makes Chantix. While Drs. Michael Steinberg and Jonathan Foulds disclosed these financial ties in the fine print at the end of the Annals article, they did not disclose their conflicts to the hundreds of patients they've steered to Chantix. (Reports that Chantix causes suicidal thoughts and behaviors in some patients are now being investigated by the FDA).
A day earlier, Pharmalot wrote about yet another prominent academic psychiatrist who failed to fully disclose financial conflicts of interest. The U.S. Senate Finance Committee discovered that Dr. Alan Schatzberg, chief of psychiatry at Stanford University, owns about $6 million in stocks in Corcept Therapeutics, whose drug is involved in a National Institutes of Health study that Schatzberg oversees. Sen. Charles Grassley (R-Iowa), a ranking member of the Senate committee, reported that Schatzberg failed to fully disclose the extent of his ties to Corcept Therapeutics. The psychiatrist also failed to fully disclose thousands of dollars in personal income from Johnson & Johnson and Eli Lilly in recent years. Here is Grassley's remarks about Schatzberg in the Congressional Record.
Schatzberg's ties to the drug industry go way back, as I reveal in my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial. In 1998, Schatzberg was the moderator of an industry-sponsored symposium that touted the benefits of a hot new antidepressant on the market, Serzone, manufactured by Bristol Myers Squibb. Schatzberg received money to moderate the symposium, as did several of the speakers that day, including Dr. Martin Keller, chief of psychiatry at Brown University, a major figure in my book. A few months after the symposium, Keller went on to publish a study in The New England Journal of Medicine touting the benefits of Serzone in treating chronic depression when prescribed with psychotherapy. For his services that year, Keller received $77,400 in consulting fees from Bristol Myers Squibb. The footnote? Serzone was removed from the market in 2004 after it was found to cause liver damage in patients, a number of whom died.
A day earlier, Pharmalot wrote about yet another prominent academic psychiatrist who failed to fully disclose financial conflicts of interest. The U.S. Senate Finance Committee discovered that Dr. Alan Schatzberg, chief of psychiatry at Stanford University, owns about $6 million in stocks in Corcept Therapeutics, whose drug is involved in a National Institutes of Health study that Schatzberg oversees. Sen. Charles Grassley (R-Iowa), a ranking member of the Senate committee, reported that Schatzberg failed to fully disclose the extent of his ties to Corcept Therapeutics. The psychiatrist also failed to fully disclose thousands of dollars in personal income from Johnson & Johnson and Eli Lilly in recent years. Here is Grassley's remarks about Schatzberg in the Congressional Record.
Schatzberg's ties to the drug industry go way back, as I reveal in my book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial. In 1998, Schatzberg was the moderator of an industry-sponsored symposium that touted the benefits of a hot new antidepressant on the market, Serzone, manufactured by Bristol Myers Squibb. Schatzberg received money to moderate the symposium, as did several of the speakers that day, including Dr. Martin Keller, chief of psychiatry at Brown University, a major figure in my book. A few months after the symposium, Keller went on to publish a study in The New England Journal of Medicine touting the benefits of Serzone in treating chronic depression when prescribed with psychotherapy. For his services that year, Keller received $77,400 in consulting fees from Bristol Myers Squibb. The footnote? Serzone was removed from the market in 2004 after it was found to cause liver damage in patients, a number of whom died.
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