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A Dangerous Practice: How Drug Companies Bend FDA Rules (cont.)

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However, all too frequently drugmakers turn their vast marketing apparatus to push doctors to prescribe FDA-approved medication for other common—and profitable—ailments. Drug companies hire researchers and highly paid ghostwriters to produce quick-hit studies that give the appearance that the medication is better than a placebo is at helping to treat additional health issues. The drug company can’t advertise the medication to consumers for off-label use, but it can start an elaborate word-of-mouth campaign that’s designed to convince health-care providers that the medication should be prescribed for other ailments. The drugmaker hires well-known doctors to speak at fancy dinners, where they tell other doctors about the off-label use of a medication. Drug-company sales representatives give doctors reprints of articles and other research materials that drugmakers help to have published to leverage influence. If the behind-the-scenes marketing campaign is successful, the drug company will take a medication that’s approved for use on a narrow ailment and convert it into a major moneymaker through the use of off-label prescriptions.

Off-label use also applies to medical devices, procedures

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For example, drugmaker Novartis revealed in January 2013 that federal prosecutors launched an investigation into the company’s marketing of FDA-approved blood-pressure medication Tekturna (aliskiren). The investigation was in progress at press time. Although Tekturna never has been shown to reduce the risk of heart attacks, strokes or heart failure, experts tell us that Novartis implies to doctors and patients that the medication will deliver the same benefits as will more-established and less expensive medications, such as water pills, ACE inhibitors and beta-blockers, all of which have excellent data that show that they reduce the risk of dangerous complications of high blood pressure, and they’re labeled as such.

Not only does Tekturna cost as much as 10 times more than do the more beneficial medications, but when Novartis performed studies to gather evidence that the medication helps to decrease the risk of a heart attack and renal complications, it found that the medication actually increased the number of nonfatal strokes and renal failure, says Jim Carlson, who is the director of Pharmacy Clinical & Health Plan Services at Group Health, which is a nonprofit health-care provider for people who reside in Idaho and Washington.

“So not only was it not beneficial, it was harmful, and we still have no evidence that it will be beneficial in any way other than reducing blood pressure, which in and of itself isn’t helpful,” Carlson says.

In July 2012, GlaxoSmithKline agreed to pay $3 billion as part of a settlement with Department of Justice over allegations that the drugmaker prepared, published and distributed to health-care providers a medical-journal article that made misleading claims about antidepressant medication Paxil (paroxetine hydrochloride). The article indicated that Paxil is effective for children and teenagers who have depression. However, FDA found that the medication could be dangerous for children, and it now requires Paxil to have a warning label that states that the use of the medication can increase the risk of suicidal thoughts and behavior for patients who are under 18.

OUT OF CONTROL. As Consumers Digest reported (“Under the Influence: How Doctors Are Courted by Drugmakers” at ConsumersDigest.com), drug companies employ a wide range of behind-the-scenes practices to persuade doctors to prescribe their products, particularly for off-label purposes.

For example, GlaxoSmithKline invited doctors to dinners, lunches and health-spa getaways that were designed to help to promote the off-label use of Paxil, according to the DOJ settlement. In another case, Abbott Laboratories paid $1.5 billion in May 2012 to resolve allegations by the federal government that the company illegally pushed its anti-seizure medication Depakote (divalproex sodium) for inappropriate off-label uses, such as the treatment of autism. The case included accusations that Abbott paid illegal kickbacks to prominent doctors who agreed to talk up the benefits of off-label use of Depakote.

Even if a drug company gets hit with lawsuits and huge settlement fees for illegal off-label marketing, the damage is diffucult to undo, experts say. Patients continue to use the medication for years after drug companies are punished, because the off-label use of the medication has been established as acceptable, experts say. After a medication has been prescribed commonly for off-label use, it’s difficult to get doctors to stop prescribing that particular medication in such a way, Fugh-Berman says.

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