BIG PHARMA’S CRIME SPREE
s a riveting report by David Evans in the current issue of Bloomberg Markets Magazine relying on recent criminal legal settlements. It leaves no doubt about the fact that Big Pharma’s buiness practices are defined by criminal activities. Finding cures is not even remotely a consideration for this industry, as it would present a financial conflict of interest.
“Across the U.S., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death. Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses.”
“About 15% of drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work.”
he widespread off-label promotion of drugs for untested, unapproved uses is a manifestation of a health-care system that is dysfunctional as it is costly. Americans are paying exorbitant prices for drugs that put their lives at increased risk of death. Indeed, a conservative estimate by the Institute of Medicine (2000) is 106,000 preventable deaths from non-error adverse prescription drug effects.
In September 2007, New York-based Bristol- Myers paid $515 million-without admitting or denying wrongdoing-to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases.
The evidence is inescapable: “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law,” says Jerry Avorn, a professor at Harvard Medical School. Indeed, rather than having a deterrent effect, the number of Big Pharma high profile criminal settlements is increasing and the settlements are getting bigger.
Bloomberg documents how companies such as Pfizer and Eli Lilly–each has been prosecuted repeatedly for the same crimes–are, if anything, emboldened as repeat offenders–ignoring FDA admonitions, as well as promises made to the Department of Justice not to break the law.
In January, 2004, “the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses. New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured prosecutor Michael Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes. What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called offlabel marketing even before the ink was dry on their plea.”
“Jeff Kindler, who became Pfizer’s general counsel in 2002, supervised the lawyers who made the promises to prosecutors. By 2004, Kindler increased the compliance budget 12-fold.”
“What Pfizer’s lawyers didn’t tell the prosecutors was that Pfizer was at that moment running an off-label marketing promotion using more than 100 of its salespeople” who were pitching Bextra for pain, a use the FDA explicitlyforbade Pfizer to promote! In 2001, the FDA had rejected Pfizer’s application to market Bextra for pain because in clinical trials the drug had shown it could cause heart damage and death.
In her guilty plea (March 30, 2009), Mary Holloway, a Pfizer regional sales manager for the Northeastern US, acknowledged that her team promoted Bextra to doctors without disclosing the risks, and also acknowledged that her team “had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn’t mention the increased risk of heart attacks in their marketing…”
Kindler became chief executive officer in 2006. In Pfizer’s ethics guide, he says stories about misbehaving companies and executives abound. “Pfizer truly stands apart,” he says. “I am proud of our record.”
Instead of being held accountable for criminal marketing practices Pfizer and its corporate divisions engaged in, on Oct. 1, Kindler was elected to the board of the Federal Reserve Bank of New York.
http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10
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