03 July 2012

Pharma Fraud

What were they thinking? In reading the overnight announcement about the US$3bn settlement by GlaxoSmithKline (GSK) with the US Government I'm struck by several passages in the Department of Justice media release -
The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. 
There's nothing like the old ghost-written journal article, an international practice highlighted here, here, here, here, here, here and the 2010 Grassley report [PDF].

Grassley noted that -
Medical ghostwriting is a practice where pharmaceutical or device companies hire medical education, marketing or communications companies to draft articles that are presented to prominent physicians and scientists to sign on as authors to increase the likelihood that the article will be published in important medical journals. Ghostwritten articles include articles that are drafted by pharmaceutical or device company employees who are not acknowledged in the final publication. The articles may be review articles, editorials or primary research papers, and they are typically presented to physicians and scientists affiliated with academic institutions. The physicians and scientists agree to sign on even if they may not be intimately familiar with the underlying data or relevant research or provided limited input on the article. Authors who make little to no contribution to a publication are also referred to as “guest” authors. 
Senator Grassley is concerned about the lack of transparency that exists in medical ghostwriting. Not only are the articles typically initiated and paid for by a pharmaceutical or device company, but also more significantly, the final publications do not disclose the company’s role and financial support for the article. Ghostwritten articles can have a significant impact on, among other things, physician prescribing practices. When prominent physicians and scientists lend their names to an article, it raises the credibility of the findings and conclusions presented. This, in turn, can affect the pocketbook of the American taxpayer since Medicare and Medicaid pay billions of dollars for prescription drugs. In addition, manipulation of medical literature could lead physicians to prescribe drugs that are more costly or may even harm patients.
A prominent researcher and professor of medicine at a leading medical school informed Committee staff that in the late 1990s and early 2000s it was common practice for pharmaceutical companies to approach him and his colleagues with requests to review and sign on as primary authors to company studies. Specifically, a company would tell a physician or scientist at an academic institution that it completed a study and would like his or her interpretation and feedback on the results of that study. In return, the company would offer that physician or scientist lead authorship on the paper, which was written by someone other than the physician or scientist. The physician or scientist would not be paid for being the author of the paper, but he or she may receive compensation for the time and effort related to reviewing and commenting on the study results. The researcher who contacted Senator Grassley stated that while he was aware of colleagues accepting the companies’ offers, his own policy is “I won’t touch it if I wasn’t involved in the concept of the study.”
The DOJ media release goes on to report that -
The United States contends that GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wllbutrin for these unapproved uses. GSK has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not bear adequate directions for these off-label uses. For the Paxil and Wellbutrin misbranding offenses, GSK has agreed to pay a criminal fine and forfeiture of $757,387,200.
 The DOJ notes that GSK
agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
GSK supports the International Federation of Pharmaceutical Manufacturers & Associations 'global position' on misbehaviour, has its own corporate 'code of best practice' [PDF] and has vaunted [PDF] its ethical excellence.