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medpundit |
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Saturday, January 15, 2005A Food and Drug Administration advisory panel recommended against the over-the-counter sale of a Merck cholesterol-lowering drug, saying that while millions of Americans could benefit from taking it, they should not begin such a regimen without a doctor's advice. The F.D.A. typically heeds such recommendations, meaning that the drug industry has been at least temporarily thwarted from creating a new segment of the drug market. But Merck and its partner in the application, Johnson & Johnson, said they would continue trying to win approval. Although their real motive is to avoid patent expirations, they put a patient-friendly spin to their mission: The companies had sought to sell a nonprescription version of Mevacor, one of the oldest of the class of drugs known as statins. With the support of some cardiologists, the companies argued that over-the-counter statins could benefit many of the estimated 39 million people whose blood cholesterol might put them at moderate risk of a heart attack but who are reluctant to spend the time and money getting a doctor's prescription. The safe use of these drugs requires monitoring of subsequent cholesterol levels (to get the correct dose) and liver enzyme levels (to check for the not infrequent side effect of liver inflammation), which - suprise - require visits to the doctor, and time, and money. If these are granted over-the-counter status, then every other medication from antibiotics to blood pressure medication to anti-depressant medications might as well be made over-the-counter, too. UPDATE: UPDATE: Trent McBride disagrees and asks why I would force patients to see a doctor if they want to improve their health. That's not what I said, and that's not the way I view the issue. Certainly, people can do things to improve their health without seeing a doctor. But, what we can't do, is allow drug companies to sell drugs that need monitoring as if they don't. There's been a lot of hand wringing lately about the safety of prescription drugs. We seem to expect our prescription drugs to be without side-effects. But this is precisely why they're prescription drugs, because they do have side effects and they need close monitoring to insure they do minimal harm. They also need the input of a consultant - such as a doctor - to help a patient decide if the drugs' risks are worth their potential benefit. Statins aren't as safe as vitamins or antihistamines. They have the potential to cause serious adverse effects, contrary to the claims of their advocates. I've had many more patients develop liver inflammation and myositis from statins than I've had depressed patients attempt suicide because I treated their depression with an SSRI. In fact, it's about a 10 to 0 ratio in fifteen years of practice. It makes no sense to put a drug that requires careful monitoring for side effects over the counter. posted by Sydney on 1/15/2005 08:35:00 AM 0 comments 0 Comments: |
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