In 2012, five pharmaceutical companies agreed to pay nearly $5.5 billion to settle allegations of fraud, including promotion of medicines for uses not approved by the FDA. The settlements represent the continued trend of record-breaking fines, settlements and lawsuits which have become a routine part of doing business for Big Pharma.
Between 2004 and 2010, major drug companies paid out $7 billion in fines, penalties and lawsuits for fraudulently marketing their drugs, making misleading claims about the drugs safety and hiding or altering studies which indicated evidence of harm. The threat of massive payouts does not appear to offer much deterrent.
Even the largest of settlements rarely dents the profits associated with the drugs involved. The largest fine ever imposed thus far - last July's $3 billion judgment against GlaxoSmithKline (GSK) for illegally marketing the antidepressants Paxil and Wellbutrin, withholding health risks data of the diabetes medication Avandia and other wrongdoings - accounted for just 11 percent of associated revenue. By contrast, in most individual cases of fraud all profits are typically confiscated and the fraudster goes to prison.
Recent year drug company fines and settlements include:
• In September 2009, Pfizer was fined $2.3 billion for misbranding the painkiller Bextra with "the intent to defraud or mislead".• In November 2011, Merck agreed to pay a fine of $950 million related to illegal promotion of the painkiller Vioxx - which has been estimated to have caused up to 60,000 or more heart attack deaths.
• In July 2012, GlaxoSmithKline agreed to pay a fine of $3 billion to resolve liabilities regarding promotion of Paxil and Avandia and other drugs and failure to report safety data.
• In December 2012, Sanofi-Aventis agreed to pay $109 million to resolve allegations that the company got inflated prices from government programs by submitting false price reports for the drug Hyalgan.
• In January 2009, Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the antipsychotic Zyprexa.
• In April 2010, AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the antipsychotic drug Seroquel for unapproved uses.
• In May 2012, Abbott was fined $1.5 billion in connection with the illegal promotion of the antipsychotic drug Depakote.
• In October 2012, Boehringer Ingelheim Pharmaceuticals Inc. agreed to pay $95 million to resolve allegations that the company promoted several drugs - including Aggrenox, Atrovent and Combivent, and Micardis - for non-approved uses.
• In December 2012, Amgen agreed to pay a $762 million fine to resolve charges that the company illegally introduced and promoted several drugs including Aranesp.
Risky drugs remain on the market
The FDA has approved an average of 24 drugs a year since 2000 - many of which pose health risks and serious long-term side effects. Drug companies greatly contribute to the problem when they conduct flawed or dishonest clinical trials.Risky drugs still on the market include:
• Type 2 diabetes drugs Avandia and Actos.
• Antidepressants Paxil, Prozac, Effexor, Zoloft and Lexapro.
• Mood stabilizer Depakote.
• Birth control pills Yaz and Yasmin.
• Acne medication Accutane.
• Blood thinners Pradaxa and Xarelto
• Osteoporosis treatment Fosamax
• Dialysis drugs GranuFlo and NaturaLyte
• Hair loss pill Propecia.
Side effects associated with the above drugs range from birth defects and liver damage to suicidal behavior, blood clots, bladder cancer, Crohn's disease, heart attacks, strokes, uncontrollable bleeding and heart failure.
As the New England Journal of Medicine recently editorialized: Fines against drug companies should be large enough that they can't be dismissed as merely "the cost of doing business"; whistleblowers should be offered more protections; and criminal charges should be filed against drug company executives for misconduct that could put them in prison.
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