If Drug Companies Put Sales Above Efficacy And Safety, Should They Get Legal Immunity By Means Of Federal Preemption Doctrine?
(Posted by Tom Lamb at DrugInjuryWatch.com)
In the first part of October 2008 we learned of yet another instance where a drug company chose to put profits over people. Yet in the near future our U.S. Supreme Court may decide that the legal doctrine of federal preemption gives legal immunity to Big Pharma for drug injury lawsuits.
An October 8, 2008 Wall Street Journal article, "Suit Alleges Pfizer Spun Unfavorable Drug Studies", explained what is new as far as bad conduct goes in the pharmaceutical sector:
Documents and emails released this week in the case in U.S. District Court in Boston suggest Pfizer's marketers influenced the drug's scientific record to boost sales at least until 2003 by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions....
According to documents in the Boston case, a European study done in the late 1990s by Warner-Lambert to measure Neurontin's use for diabetic nerve pain produced consternation at Pfizer after it failed to find a significant effect. "I think we can limit the potential downsides of the ... study by delaying the publication for as long as possible," wrote Michael Rowbothan, then Neurontin's marketing team leader, in a 2000 email sent after Pfizer bought Warner-Lambert. He added that "it will be more important to how WE write up the study."
A second October 8 article, "Experts Conclude Pfizer Manipulated Studies", published by the New York Times, added some commentary and then put this latest incident in context:
One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.” ...
The expert reports, unsealed Monday in a federal court in Boston, add to accusations that the pharmaceutical industry has controlled the flow of clinical research data, blurring the lines between science and marketing.
In April, for example, a group of academic doctors questioned the validity of drug industry research after finding that Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors. Vioxx, a painkiller, was withdrawn from the market in 2004 after research indicated it could cause strokes and heart attacks.
Last winter, Merck and Schering-Plough were criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin that showed the drug did not slow the growth of plaque in arteries. In the case of Pfizer’s Neurontin, the negative studies would have increased doubts about the drug’s value for several unapproved uses — treating bipolar disorder, controlling certain types of pain and preventing migraine headaches, according to the expert opinions.
What is even more remarkable, in light of this type of misconduct, is that the U.S. Supreme Court, in the Wyeth v. Levine case, may soon give these drug companies immunity to drug injury lawsuits by application of the federal preemption legal doctrine to those cases.
It seems to me that this legal immunity is a get-out-of-jail-free card that the drug companies cannot and should not be trusted with for the sake of American drug safety.