Should You Trust Your Doctor? Off Label Drug Prescriptions Reach Dangerous Levels, Critics Charge

Nov. 9, 2009 - PRLog -- Most of us  trust our Doctor with our health and don't ask a lot of questions when he or she writes us a prescription. We're just happy to get relief. But there is now new evidence coming from numerous criminal cases that suggests we should think twice before having that prescription filled at the pharmacy.

It's called off-label drug prescriptions and it accounts for about 15 percent of all drug sales in the U.S., according to a study by Randall Stafford, a medical professor at Stanford University in Palo Alto, California. Off-label drugs are drugs that are prescribed for conditions other than what they were tested and approved for by the FDA.

The problem arises because the government has allowed Doctors to practice under their own discretion, trusting that they will fulfill their duty to responsibly carryout approved medical practices. Some do, but most, studies show, are too often influenced by the pharmaceutical companies and their large coffers to push drugs for various maladies other than those for which they had been approved and properly vetted. Take the case of Zyprexam, a drug approved to treat schizophrenia but more often is used to treat Alzheimer patients. Between 2000 and 2008 the drug generated 36 billion dollars in revenue, even though Lilly, the drug's manufacturer, had evidence that it doubled the likelihood of fatalities in Alzheimer patients.

Zyprexam is illustrative for another reason. It further highlights the growing criminal prosecution against these abuses and the drug companies indifference to these charges and even convictions. Records show that Zyprexam provided Lilly with $36 billion in revenue from 2000 to 2008. The fine they paid for the promoting Zyprexam for use in Alzheimer patients was but a small fraction of this amount, less even than the drug's marketing budget.

This is not unusual. Pfizer agreed to pay $2.3 billion in fines and penalties for marketing Bextra, a drug approved only for the relief of arthritis and menstrual discomfort but was prescribed for treatment of acute pains of all kinds, and three other drugs cited in the Sept. 2 plea agreement. The fine represented just 14 percent of its $16.8 billion in revenue from selling those medicines from 2001 to 2008.

As drug makers repeatedly plead guilty, they’ve shown they’re willing to pay hundreds of millions of dollars in fines as a cost of generating billions in revenue. "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. “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 the case of Pfizer, they offered doctors up to $1,000 a day to allow a Pfizer salesperson to spend time with the physician and his patients, according to a whistle-blower lawsuit filed by John Kopchinski, who worked as a salesman at Pfizer from 1992 to 2003.

“By ‘pairing up’ with a physician, the sales representative was able to promote over a period of many hours, without the usual problems of gaining access to prescribing physicians,” Kopchinski says. “In essence, this amounted to Pfizer buying access to physicians.”

Increasingly more Americans are losing faith with the grip pharmaceutical companies have on how medicine is being practiced in their communities and are seeking alternative practices. According to Sarah Richards of Homegrown Herb and Tea, an herbal tea apothecary which specializes in the sale of Ayurvedic medicinal herbal teas in Portland, Maine and online at http://www.homegrownherbandtea.com, many of her customers have been frustrated by the medical industry and are taking matters into their own hands.  "People are becoming educated about their health. They no longer trust a system that is being driven by money and profit. We're seeing people come back here again and again because they're finding something that works for them, that helps them heal themselves."

But if you must seek medical attention, advises says Peter Lurie, deputy medical director of Public Citizen, a Washington-based public interest group, "You should ask whether their prescriptions are for FDA-approved uses, and if not, whether strong evidence supports using the drug, particularly if it can be dangerous."

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Homegrown Herb and Tea is an herbal tea apothecary located in Portland, Maine and online at http://www.homegrowntea.com. We serve wellness tea, Ayurvedic teas and specialty teas.