We, your Executive Committee, want to keep you informed about major issues we’re working on, specifically with the Academy around ethical issues in science and publishing.
A paper was published in JAACAP (Keller et al., 2001) stating the efficacy of paroxetine for major depression for adolescents. However, the data from the original study (Study 329) was altered by GlaxoSmithKlein. They hired a consultant ghost-writer that did not report serious side effects, nor the real result of paroxetine having no significant benefit. GSK was fined $3 billion by the Department of Justice, though the published papers from this data continue unchanged.
We at NC-ROCAP believe that research is integral to clinical practice and have taken action to ensure ethical standards. We have:
• Corresponded with the AACAP Ethics Committee which was told by Leadership not to investigate this scandal.
• Corresponded with the Editor-in-Chief, Dr. Andres Martin, asking for his reasons for not retracting the fraudulent article. He did not respond to our inquiry nor one from Central California’s ROCAP
• Corresponded with the current AACAP President, who described the issue as one of “Editorial
Independence” at the recent Assembly meeting. We believe it is one of “Editorial Integrity”.
• Passed an Action Statement at the Assembly, requesting that Dr. Martin explain to the October Assembly why he has chosen not to retract what the DoJ calls a “false and misleading article.”
• Sent a statement outlining the above to AACAP President Joshi, requesting transparency.
A newly written article is expected to be published soon in the British Medical Journal using the original, unaltered data of Study 329 which will confront us and the media with distinctly different versions of hte paper published in our Journal in 2001. Although the paper has been challenged a number of times in the literature and severely criticized in court by the Attorney General of New York State and the Federal DOJ, it continues to be cited in the professional literature.
We are asking for the highest levels of our organization to take ethical actions to ensure the best care for our patients and to improve the public’s view of our profession.
Please contact me (Suzan Song, MD, MPH, PhD(c) at firstname.lastname@example.org) if you have questions or wish to be a part of this action.
Sincerely, The Executive Committee of NC-ROCAP
GSK has agreed to plead guilty and pay $3 billion as part of this criminal and civil resolution.
Largest combined federal and state health care fraud recovery in a single global resolution in the history of theUnited States.CRIMINAL RESOLUTION
GSK has agreed to plead guilty to three misdemeanor violations of the Food, Drug and Cosmetic Act:
o Regarding Paxil, GSK will plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C. §§ 331(a), 333(a)(1)
o Regarding Wellbutrin, GSK will plead guilty to distribution of a misbranded drug due to inadequate directions for use, in violation of 21 U.S.C. §§ 331(a), 333(a)(1) & 352(f)(1).
o Regarding Avandia, GSK will plead guilty to failure to report data to the FDA, in violation of 21 U.S.C. §§ 331(e), 333(a)(1) & 355(k)(1).
The information, filed in the District of Massachusetts, alleges that:
- The FDA has never approved Paxil for any purpose for treating patients under age 18.
- From 1999 to 2003, during sales calls, dinner meetings, spa programs, lavish weekend conferences to places such as Puerto Rico and Hawaii, through a false and misleading medical journal article, and through the distribution of free samples for patient use, GSK promoted Paxil to doctors for the treatment of depression and, to a lesser extent, obsessive-compulsive disorder in patients under age 18.
GSK conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, GSK failed to demonstrate efficacy on the endpoints identified in the study protocols.
Nevertheless, GSK hired a contractor to write an article on one of the studies that was published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). The article stated that Paxil “is generally well tolerated and effective for major depression in adolescents.” The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol.
GSK’s marketing team distributed the JAACAP article to all of the Paxil sales representatives with a cover memo that stated that Paxil had demonstrated “REMARKABLE Efficacy and Safety in the treatment of adolescent depression.” Some GSK sales representatives used the article to urge doctors to prescribe Paxil to treat patients under age 18.
GSK did not write a medical journal article about the other two unfavorable studies nor did it inform its sales representatives about the results of those studies.