British registered company, GlaxoSmithKline, faces $3 billion in penalties after pleading guilty to the biggest health care fraud case in history. GSK admitted that physicians had been bribed to push potentially dangerous drugs in exchange for Madonna tickets, Hawaiian holidays, cash and lucrative speaking tours. They also admitted distributing misleading information regarding the antidepressant Paxil. The report claimed that it was suitable for children, but failed to acknowledge data from studies proving its ineffectiveness in children and adolescents.
Part of the case made by U.S. prosecutors that led to GlaxoSmithKline‘s $3 billion settlement today is that the company used a network of paid experts, speaking to doctors and to the press, to promote uses of its drugs that had not been approved by the Food and Drug Administration. According to the Department of Justice’s complaint, one of those paid experts was celebrity physician Dr. Drew Pinsky, then the host of the radio show Loveline, which was also being broadcast on MTV. Pinsky has gone on to host Celebrity Rehab, Dr. Drew on HLN, and Dr. Drew’s Lifechangers on the CW.
WASHINGTON, Aug 23 (Reuters) – The U.S. National Institutes of Health revised on Tuesday its 16-year-old conflict of interest rules for medical researchers, lowering the amount of money that constitutes a financial conflict and expanding the required disclosures….Concern about the integrity of research in the United States has grown since 2008, when Iowa Republican Sen. Charles Grassley criticized prominent Harvard University psychiatrist Dr. Joseph Biederman and others for failing to fully disclose payments from drug companies.
The primary promoters–inventors, one might say– of diagnosing children with “bipolar” disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.
An investigation, prompted by Sen. Charles Grassely, was conducted by Harvard University-affiliated Massachusetts General Hospital. It concluded (earlier this month) that psychiatrist Joseph Biederman and two of his proteges, Thomas Spencer and Timothy Wilens -each of who failed to disclose millions of dollars they had each received from the makers of antipsychotics, the drugs they promoted for the treatment of bipolar in children–had indeed violated the University’s/ and hospital’s conflict of interest reporting standards. The companies that paid them millions include: Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.
How ghostwriting feeds Big Pharma profits – Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.
Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.