[News] When drug makers' profits outweigh penalties

Birdbomb

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When drug makers' profits outweigh penalties


Across the United States, pharmaceutical companies have pleaded guilty to criminal charges or paid penalties in civil cases when the Justice Department finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death.



It used to be legal for companies to promote drugs in the United States for any use. Congress banned the practice in 1962, requiring pharmaceutical companies to first prove their drugs were safe and effective for specific uses.
If the law is clear, why do drug companies keep breaking it? The answer lies in economics. Pharmaceutical companies spend about $1 billion to develop and test a new drug. To recoup their investment, the companies want doctors to prescribe their drugs as widely as possible....

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Bernard

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David Evans said:
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Companies regard the risk of multimillion-dollar penalties as just another cost of doing business, says Lon Schneider, a professor at the University of Southern California's Keck School of Medicine in Los Angeles. In 2006, he led a study for the National Institute of Mental Health of off-label use of drugs, including Zyprexa.

"There's an unwritten business plan," he says. "They're drivers that knowingly speed. If stopped, they pay the fine, and then they do it again."

In pushing off-label use of drugs, companies find ready and willing partners in physicians. Under the fragmented system of U.S. medical regulation, it's legal for doctors to prescribe FDA-approved drugs for any use. The FDA has no authority over doctors, only over drug companies, regarding off-label practices. It's up to the states to oversee physicians.

"I think the physician community has to take some ownership responsibility and do their own due diligence beyond the sales and marketing person," says Boston's former U.S. Attorney Michael Sullivan.

Doctors generally don't tell people they're prescribing drugs pitched to them by pharmaceutical salespeople for unapproved treatments, says Peter Lurie, former deputy medical director of Public Citizen, a Washington-based public interest group. Most doctors don't keep track of FDA-approved uses of drugs, he says.
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It's a strange system we have. There are really just a few gatekeepers deciding what is OK and what isn't.

David Evans said:
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Pfizer's Neurontin is a case in point. The FDA approved the drug as a supplemental medication to treat epilepsy in 1993. Pfizer took in $2.27 billion from sales of Neurontin in 2002. A full 94 percent -- $2.12 billion -- of that revenue came from off-label use, according to the prosecutors' 2004 Pfizer sentencing memo.
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Much of what prosecutors learned about Warner-Lambert's marketing of Neurontin comes from a former employee, David Franklin, who holds a Ph.D. in microbiology.

Franklin, 48, whose title at Warner-Lambert was medical liaison, says his job involved more salesmanship than science. He told doctors that Neurontin was the best drug for a dozen off-label uses, including pain relief, bipolar disease and depression.

"Technically, I had responsibility for answering physician questions about all of Parke-Davis's drugs," Franklin says. "In practice, my real job was to promote Neurontin for off-label indications heavily -- to the exclusion of just about everything else."
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Sick to my stomach doesn't begin to cover it. Unsually when I don't approve of a company I just stop using their service or product, however these companies know we have few, if no choises in the matter.
The measure by which these companies are heald accountable would be laughable if not for the lives that they destroy each year. Until such point as some one of rank is criminally charged with the death of an individual and serves "real jail" time in a "real jail" these habits will not change. Unfortunatly I do not see that happening any time soon.
 
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