WATCHDOG EYES FDA ACTION TO DEEM GHOSTWRITTEN ARTICLES AS OFF-LABEL ADS
19 August 2011
FDA Week
A government watchdog who has actively targeted industry influence on FDA is now considering pressing the agency to be more active and vigilant to deem some ghostwritten medical journal articles as off-label promotion, although any agency action could meet legal challenges based on a decade-old lawsuit and the First Amendment, sources said. However, if FDA cannot curb ghostwriting, the court system could be leveraged against this type of research, according to an academic who has studied this issue.
Project on Government Oversight (POGO) Investigator Paul Thacker -- who recently garnered substantial attention after pressing FDA not to loosen its advisory committee conflict-of-interest waiver standards – now has his sights on urging the agency to use its enforcement powers to stymie the practice of industry ghostwriting medical journal articles on off-label uses (see FDA Week, Aug. 5). Thacker, who has been critical of industry ghostwriting for years, said pressing FDA on this issue might be his next project, noting that FDA should go after the most egregious examples of misleading ghostwritten articles.
"From the extent that the scientific publications have become a form of marketing, FDA needs to look at that," Thacker said, adding that he is considering to "really go after FDA on this stuff." He said the agency should target ghostwritten articles "to the extent to which they are being used to promote off-label."
As an example of ghostwritten articles that he contends could catch the agency's ire, Thacker referenced Study 329 for the antidepressant Paxil. The investigators of the study assessed whether the GlaxoSmithKline drug is safe and effective in treating adolescent patients with major depression and obsessive compulsive disorder. The study was criticized by some for in their view only promoting positive findings and omitting negative data, especially since the medicine became a major seller.
"Everything in there shows it was an advertisement; it was a paid-for advertisement and FDA's done nothing about it," Thacker said. "This is the next thing that I'm really trying to look at."
But GSK counters that its involvement in the study has been disclosed and documented, arguing that the firm and the investigators "acted properly and appropriately in discussing the results," according to a GSK official.
The non-industry authors of the study commented and revised drafts of the article ahead of its publication and controlled the content, with the article also subject to the peer-review process and the decision of the Journal of the American Academy of Child and Adolescent Psychiatry on whether to publish the study.
"It would be simply wrong to characterize publication of peer-reviewed manuscripts as off-label promotion," the GSK official said, adding that the firm follows criteria established by the International Committee of Medical Journal Editors or specific journals' more stringent rules on participating in the drafting of articles.
FDA declined to comment for this article, but the agency published in 2009 guidance for industry on rules for distributing medical journal articles. Good reprint practices include that the article be peer-reviewed and published by an organization with an expert editorial board, FDA says.
Ghostwriting has garnered substantial congressional attention in recent years. Sen. Chuck Grassley (R-IA), ranking member on the Senate Judiciary Committee, has investigated ghostwriting practices, including when he was the top Republican on the finance panel. Thacker was a former investigator for Grassley before joining POGO.
Any FDA activity to curtail industry participation in medical journal articles is likely to encounter legal challenges, sources said.
Notably, FDA attempts to thwart publication or dissemination of ghostwritten articles could run afoul of the First Amendment or the late 1990's decision in Washington Legal Foundation v. Friedman, where the U.S. District Court for the District of Columbia ruled that FDA limits on medical journal article distribution by medical product manufacturers would violate commercial free speech.
"Obviously, I think that would be unconstitutional," WLF Chief Counsel Richard Samp said, referencing any FDA activity to deem ghostwritten medical journal articles as off-label promotion. "We have a permanent injunction in place against efforts by FDA to control statements made in peer-reviewed journal articles," he added.
As long as the article has been published by a well-regarded medical journal that conducts a peer review process, then ghostwritten studies are protected from the agency, Samp argued.
"It doesn't make any difference who is the original source of the publication if, at the end of the day, it is published by a reputable publication ... that has some degree of independent assessment," he said. "FDA would be in violation of the First Amendment if it were to prohibit publication or go after a manufacturer if it believes the manufacturer had some role in initially subjecting or procuring the initial writing-up of the report."
Thacker noted that he has not yet conducted a review of the legal issues surrounding any FDA activity on this subject, but said that FDA should "prosecute" the relevant parties and that if FDA action is possible, Study 329 could be targeted.
"This is how you, basically, subtly market your products and make it look like it's science when it's really just promotion," Thacker said.
In the event FDA's hands are tied, other institutions -- notably the court system -- could be used to curtail ghostwriting, according to Trudo Lemmens, a law professor at the University of Toronto who has been critical of ghostwriting.
He argues that citizens, interest groups and academics could form class action lawsuits against
manufacturers or journal authors that provide misleading information in their studies that are intended to, he says, promote off-label uses. Further, he adds that courts could consider expert testimony as conflicted or unreliable if the individual has signed-off on a ghostwritten article that is misleading.
Various groups "should look at lawsuits against the academics that have been involved in ghostwriting," Lemmens said, adding that there are "different ways in which we can use the law to fight the particular practice of ghost writing."
Ideally, Lemmens said he would support creating a parallel regulatory agency or office to review data, albeit that proposal might not have strong prospects in the United States due to, among other issues, budget constraints.
"The ideal solution would be to say that it's actually clinical trial data," he said. "The government should actually direct the control of this crucial health information." -- Ben Moscovitch
19 August 2011
FDA Week
A government watchdog who has actively targeted industry influence on FDA is now considering pressing the agency to be more active and vigilant to deem some ghostwritten medical journal articles as off-label promotion, although any agency action could meet legal challenges based on a decade-old lawsuit and the First Amendment, sources said. However, if FDA cannot curb ghostwriting, the court system could be leveraged against this type of research, according to an academic who has studied this issue.
Project on Government Oversight (POGO) Investigator Paul Thacker -- who recently garnered substantial attention after pressing FDA not to loosen its advisory committee conflict-of-interest waiver standards – now has his sights on urging the agency to use its enforcement powers to stymie the practice of industry ghostwriting medical journal articles on off-label uses (see FDA Week, Aug. 5). Thacker, who has been critical of industry ghostwriting for years, said pressing FDA on this issue might be his next project, noting that FDA should go after the most egregious examples of misleading ghostwritten articles.
"From the extent that the scientific publications have become a form of marketing, FDA needs to look at that," Thacker said, adding that he is considering to "really go after FDA on this stuff." He said the agency should target ghostwritten articles "to the extent to which they are being used to promote off-label."
As an example of ghostwritten articles that he contends could catch the agency's ire, Thacker referenced Study 329 for the antidepressant Paxil. The investigators of the study assessed whether the GlaxoSmithKline drug is safe and effective in treating adolescent patients with major depression and obsessive compulsive disorder. The study was criticized by some for in their view only promoting positive findings and omitting negative data, especially since the medicine became a major seller.
"Everything in there shows it was an advertisement; it was a paid-for advertisement and FDA's done nothing about it," Thacker said. "This is the next thing that I'm really trying to look at."
But GSK counters that its involvement in the study has been disclosed and documented, arguing that the firm and the investigators "acted properly and appropriately in discussing the results," according to a GSK official.
The non-industry authors of the study commented and revised drafts of the article ahead of its publication and controlled the content, with the article also subject to the peer-review process and the decision of the Journal of the American Academy of Child and Adolescent Psychiatry on whether to publish the study.
"It would be simply wrong to characterize publication of peer-reviewed manuscripts as off-label promotion," the GSK official said, adding that the firm follows criteria established by the International Committee of Medical Journal Editors or specific journals' more stringent rules on participating in the drafting of articles.
FDA declined to comment for this article, but the agency published in 2009 guidance for industry on rules for distributing medical journal articles. Good reprint practices include that the article be peer-reviewed and published by an organization with an expert editorial board, FDA says.
Ghostwriting has garnered substantial congressional attention in recent years. Sen. Chuck Grassley (R-IA), ranking member on the Senate Judiciary Committee, has investigated ghostwriting practices, including when he was the top Republican on the finance panel. Thacker was a former investigator for Grassley before joining POGO.
Any FDA activity to curtail industry participation in medical journal articles is likely to encounter legal challenges, sources said.
Notably, FDA attempts to thwart publication or dissemination of ghostwritten articles could run afoul of the First Amendment or the late 1990's decision in Washington Legal Foundation v. Friedman, where the U.S. District Court for the District of Columbia ruled that FDA limits on medical journal article distribution by medical product manufacturers would violate commercial free speech.
"Obviously, I think that would be unconstitutional," WLF Chief Counsel Richard Samp said, referencing any FDA activity to deem ghostwritten medical journal articles as off-label promotion. "We have a permanent injunction in place against efforts by FDA to control statements made in peer-reviewed journal articles," he added.
As long as the article has been published by a well-regarded medical journal that conducts a peer review process, then ghostwritten studies are protected from the agency, Samp argued.
"It doesn't make any difference who is the original source of the publication if, at the end of the day, it is published by a reputable publication ... that has some degree of independent assessment," he said. "FDA would be in violation of the First Amendment if it were to prohibit publication or go after a manufacturer if it believes the manufacturer had some role in initially subjecting or procuring the initial writing-up of the report."
Thacker noted that he has not yet conducted a review of the legal issues surrounding any FDA activity on this subject, but said that FDA should "prosecute" the relevant parties and that if FDA action is possible, Study 329 could be targeted.
"This is how you, basically, subtly market your products and make it look like it's science when it's really just promotion," Thacker said.
In the event FDA's hands are tied, other institutions -- notably the court system -- could be used to curtail ghostwriting, according to Trudo Lemmens, a law professor at the University of Toronto who has been critical of ghostwriting.
He argues that citizens, interest groups and academics could form class action lawsuits against
manufacturers or journal authors that provide misleading information in their studies that are intended to, he says, promote off-label uses. Further, he adds that courts could consider expert testimony as conflicted or unreliable if the individual has signed-off on a ghostwritten article that is misleading.
Various groups "should look at lawsuits against the academics that have been involved in ghostwriting," Lemmens said, adding that there are "different ways in which we can use the law to fight the particular practice of ghost writing."
Ideally, Lemmens said he would support creating a parallel regulatory agency or office to review data, albeit that proposal might not have strong prospects in the United States due to, among other issues, budget constraints.
"The ideal solution would be to say that it's actually clinical trial data," he said. "The government should actually direct the control of this crucial health information." -- Ben Moscovitch
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