Here's a report from Public Citizen summarizing the recent trend in payments by the pharmaceutical industry of civil and criminal monetary penalties. It seems that pharma has now eclipsed the defense industry as the leading defrauder of the US government under the False Claims Act. Some of the report's findings:
In the last twenty years, pharma firms have made 165 settlements for $19.8 billion in penalties. Three-quarters of these (both in terms of numbers of settlements and in terms of fines paid) have occurred in the last five years. GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough accounted, together, for more than half of the twenty years' penalties. Illegal off-label promotion of drugs has triggered the largest number of federal fines. Overcharging state Medicaid programs triggered the largest state-level fines. Actions initiated by industry whistleblowers gave rise to 67 percent of payouts over the last decade.
The report concludes that fines are probably not sufficient motivation to get high-profit-margin firms to behave. It recommends the application of the "Park Doctrine" to pharma executives--a doctrine under which individual executives can be convicted of criminal misdemeanors based on corporate misbehavior, even if they weren't personally aware of the problem. The doctrine is designed to motivate executives to become pro-active in preventing their firms from engaging in criminal misconduct.
The report's call for the FDA to revive the long-neglected Park Doctrine in fact follows recent signals from the FDA that it intends to do just that. The law firm of Hyman, Phelps and McNamara has an informative powerpoint presentation on the FDA's past and future use of the Park doctrine, here. The clear message from the FDA has been, "Expect some prosecutions of pharma executives soon!"
Showing posts with label fraud. Show all posts
Showing posts with label fraud. Show all posts
Friday, January 13, 2012
Thursday, January 5, 2012
Wakefield Sues BMJ Editor for Defamation
Wow. Author of the a now-discredited Lancet article which started a vaccine scare by falsely linking MMR vaccination to autism onset, Andrew Wakefield is suing BMJ's editor, Fiona Godlee, and British investigative journalist Brian Deer, for defamation of his character. The complaint, filed in Travis County, Texas, is here. It focuses fairly narrowly on statements by Godlee and Deer to the effect that Wakefield manipulated or falsified data in the study.
The UK's General Medical Council, after the longest hearing in its history, found Wakefield guilty of serious professional misconduct in connection with the conduct of the research underlying the article, and erased him from its rolls. But they didn't specifically find that he altered data in the study; their main complaint about the article itself was that it mischaracterized the children under study--especially the means by which, and purpose for which, they were recruited. The GMC's findings spoke mainly to other forms of research and clinical misconduct. To review, the GMC found that Wakefield violated the limits of his appointment as an Honorary Consultant in a "breach of trust of patients and employers alike," and mismanaged funds, and failed to disclose "matters which could legitimately give rise to a perception of a conflict of interest," and conducted research on vulnerable children without required ethics review, and concealed that fact, and repeatedly breached "fundamental principles of research medicine," and acted contrary to the clinical interests of 9 of the 12 children mentioned in the article, and violated his duties as a senior author, and failed to correct his mistakes when given the chance, and made "dishonest and irresponsible" statements to the GMC board itself.
Of course, the fact that Wakefield was unprofessional in a bunch of different ways doesn't mean that he was unprofessional in all of the ways that Godlee or Deer have, at one time or another, alleged. It's just possible that one or the other of them has said something factually wrong by accusing Wakefield of some specific kind of scumbaggery that he didn't actually engage in. If so, may the damages found be very, very small.
Because the damage caused by Wakefield hasn't been small. The publicity around his unethical research likely caused children to die of completely preventable childhood diseases, and is certainly still causing misguided parents to fail to vaccinate their children. It is depressing to note that here, the Autism Action Network is already trumpeting Wakefield's suit against Deer and a woman whom they call "Fiona Godley." Their view is that Wakefield and his co-author John Walker-Smith "had their medical licenses suspended for their refusal to recant their hypothesis." They don't mention the actual GMC findings against Wakefield, nor those against Walker-Smith (which you can read here), nor the fact that in 2004, six years before the GMC acted, Walker-Smith and nine of Wakefield's other co-authors specifically retracted the portion of the paper that posited a link of MMR with autism.
The UK's General Medical Council, after the longest hearing in its history, found Wakefield guilty of serious professional misconduct in connection with the conduct of the research underlying the article, and erased him from its rolls. But they didn't specifically find that he altered data in the study; their main complaint about the article itself was that it mischaracterized the children under study--especially the means by which, and purpose for which, they were recruited. The GMC's findings spoke mainly to other forms of research and clinical misconduct. To review, the GMC found that Wakefield violated the limits of his appointment as an Honorary Consultant in a "breach of trust of patients and employers alike," and mismanaged funds, and failed to disclose "matters which could legitimately give rise to a perception of a conflict of interest," and conducted research on vulnerable children without required ethics review, and concealed that fact, and repeatedly breached "fundamental principles of research medicine," and acted contrary to the clinical interests of 9 of the 12 children mentioned in the article, and violated his duties as a senior author, and failed to correct his mistakes when given the chance, and made "dishonest and irresponsible" statements to the GMC board itself.
Of course, the fact that Wakefield was unprofessional in a bunch of different ways doesn't mean that he was unprofessional in all of the ways that Godlee or Deer have, at one time or another, alleged. It's just possible that one or the other of them has said something factually wrong by accusing Wakefield of some specific kind of scumbaggery that he didn't actually engage in. If so, may the damages found be very, very small.
Because the damage caused by Wakefield hasn't been small. The publicity around his unethical research likely caused children to die of completely preventable childhood diseases, and is certainly still causing misguided parents to fail to vaccinate their children. It is depressing to note that here, the Autism Action Network is already trumpeting Wakefield's suit against Deer and a woman whom they call "Fiona Godley." Their view is that Wakefield and his co-author John Walker-Smith "had their medical licenses suspended for their refusal to recant their hypothesis." They don't mention the actual GMC findings against Wakefield, nor those against Walker-Smith (which you can read here), nor the fact that in 2004, six years before the GMC acted, Walker-Smith and nine of Wakefield's other co-authors specifically retracted the portion of the paper that posited a link of MMR with autism.
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