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Special Report

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

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For example, menopausal hormones that originally were approved by FDA to treat the hot flashes and vaginal dryness that are associated with menopause still are prescribed as a treatment for cardiovascular disease and even dementia in post-menopausal women. This comes despite a 2002 study that showed that the medication could increase the risk of heart disease, stroke, blood clots and breast cancer. Every clinical trial since 2002 that studied the off-label use of menopausal hormones showed that such prescriptions “do harm and don’t work,” Fugh-Berman says.

Of the three aforementioned drug companies that we requested to interview, only two responded, and only one—GlaxoSmithKline—answered specific questions. Yet we believe that the responses that we received from GlaxoSmithKline reveal a disturbing truth about the business of off-label prescriptions. For instance, GlaxoSmithKline tells Consumers Digest that it “denies and vigorously disputes” the allegations that were made by FDA in the aforementioned case that GlaxoSmithKline agreed to settle. So why did GlaxoSmithKline agree to pay $3 billion to settle charges that it says aren’t true? Independent experts tell us that drug companies see such settlements as a cost of doing business. If a drugmaker can make, say, $200 million by selling an off-label prescription that relies on misleading or illegal marketing, the drug company sees no harm in having to pay, say, $20 million to FDA to settle a lawsuit, because drugmakers would come out $180 million ahead.

Furthermore, Pharmaceutical Research and Manufacturers of America (PhRMA), which is a trade group for drugmakers, tells Consumers Digest that drug companies would have to spend significantly more time and money than they do now to conduct tests that would justify the off-label use of a particular medication.

“The process is one that can take more than 2 years and costs hundreds of millions of dollars in certain circumstances,” PhRMA’s James Spears says. “Full-scale, double-blind placebo-controlled [medication] trials are extremely expensive.”

Spears says it’s better for consumers to let doctors decide whether patients should use an off-label prescription rather than to have drug companies use more resources to meet a higher test-result threshold, because doctors have the freedom and expertise to determine what treatments work best for their patients. We can’t help but wonder whether Spears merely wants to allow drugmakers to make more money while they dodge responsibility.

IN YOUR HANDS. The unfortunate truth is that off-label use of medication can leave consumers—and sometimes even doctors—in the dark. The problem is that few methods exist for patients to know whether they’re being prescribed a medication for off-label use unless they carefully read the medication’s package insert or grill their doctor or pharmacist about the prescription.

Even most doctors aren’t aware that the medications that they prescribe are for on-label or off-label use, says Dr. Eric Larson, who studies the cost-effectiveness of health care at Group Health’s Research Institute. “If you asked me about the drugs I prescribe, ‘Which are off-label and on-label?’ I might have to look it up to be sure that I knew the answer,” Larson says.

What are your options as a patient? First, you have to ask your doctor whether the medication is being prescribed for on-label or off-label use; the doctors who do know typically won’t volunteer such information, because it’s so common in medical practice to prescribe medications for off-label use, Fugh-Berman says. If a doctor says he/she is prescribing a medication for off-label use, ask him/her why. A good reason might exist, and doctors should be able to tell you what it is.

For instance, a legitimate reason could be that the medication no longer is under patent, which means that it’s so inexpensive that no economic incentive exists for a drug company to conduct the tests that prove that the medication works for a particular off-label use. Only when medications are under patent do companies want to spend the money to do such tests, because they know that they—and only they—will benefit. Nonetheless, experts tell us that by the time a medication has been around long enough to come off patent, medical experts typically have a good sense of whether the medication is safe and effective for off-label use.

If the doctor can’t give you a legitimate reason for the off-label use, you should request that he/she give you an on-label prescription.

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