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Healthy Skepticism Library item: 17774

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Kesselheim AS, Studdert DM, Mello MM
Whistle-Blowers' Experiences in Fraud Litigation against Pharmaceutical Companies
NEJM 2010 May 13; 362:(19):1832-1839
http://content.nejm.org/cgi/content/full/362/19/1832


Abstract:

Prosecution and prevention of health care fraud and abuse are essential to reducing U.S. health care spending.1,2,3 A number of recent high-profile cases have uncovered suspect business practices and led to substantial recoveries; in September 2009, for example, Pfizer paid $2.3 billion to settle allegations that it marketed its drugs illegally to physicians, leading to unnecessary payments by the government.4

Currently, 90% of health care fraud cases are “qui tam” actions in which whistle-blowers with direct knowledge of the alleged fraud initiate the litigation on behalf of the government.5 Qui tam derives from the Latin phrase qui tam pro domino rege quam pro se ipso in hac parte sequitur, meaning “who as well for the king as for himself sues in this matter.” If a qui tam action leads to a financial recovery, the whistle-blower stands to collect a portion of the award. From 1996 through 2005, qui tam actions led to more than $9 billion in recoveries.6 Although such actions are touted as cost-effective7 and may deter inappropriate behavior,8 little is known about how well the qui tam process works.

From their vantage point at the center of the process, whistle-blowers have valuable insights. Popular portrayals of whistle-blowers vary widely: some anecdotes paint them as heroes struggling against corporate greed, emphasizing the hardships and retaliation they must endure; other accounts question their motives and the “excessive” rewards they receive.9,10,11,12,13,14

The goal of this study is to shed light on the motivations and experiences of whistle-blowers in cases of major health care fraud. We conducted interviews with whistle-blowers who were key informants in recent prosecutions brought against pharmaceutical manufacturers. Enforcement actions against pharmaceutical manufacturers have become the most lucrative type of health care fraud litigation on the basis of recovery amounts (average and gross).6,15,16


Notes:

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909