DRUG SAFETY: SANITY PREVAILS FOR ONCE

Celebrate. Celebrate.No, that's not the return of the Celebrex TV ad with its aerobic arthritics. That's the euphoria of physicians delighted with a Food and Drug Administration advisory panel's recommendation earlier this year that Vioxx and its cousins Bextra and Celebrex (all medicines known as Cox-2 inhibitors) should remain on the market, despite evidence they increase heart disease risk in some people. The panelists reached their decision after weighing all the data and concluding the benefits of these pain-relieving drugs outweighed the risks

Specifically, these scientists acknowledged that, for some patients, these prescription drugs were uniquely effective in reducing pain from arthritis and other causes. For others — concerned about ulcers associated with aspirin and other OTC analgesics — the Cox-2 inhibitors offered the advantage of minimizing potentially serious effects of stomach irritation.

Vioxx is back in the news this week as pretrial hearings in hundreds of federal liability cases against Merck begin in New Orleans (Merck asked that the cases be placed under one judge for pretrial motions so it isn't dealing with hundreds of similar cases in different courts). Now is an appropriate time for everyone to take a fresh look at the benefit-risk equation for Vioxx and the other Cox-2 inhibitors.

The risks — increased risk of heart disease in some who use the drugs — have been well publicized. Much less publicity has been given to a spectrum of real and potential benefits that go way beyond reduced risk of stomach irritation. These little-discussed benefits would have been lost, perhaps permanently — had Vioxx, Bextra and Celebrex been driven from shelves in pursuit of perfect safety, an unattainable goal.

For example, there is substantial evidence Cox-2 inhibitors can reduce development of colon polyps, precursors of colon cancer. Indeed, Celebrex is FDA-approved for those genetically prone to colon cancer. Ironically, the 2004 study that revealed the elevated heart attack risk of Vioxx was primarily designed to further establish the drug's efficacy in protecting against colon cancer. And while the results of that interrupted trial have not yet been published, there is good reason to believe they will confirm the protective effects against colon cancer established in research over the last 10 years.

At the time of its withdrawal from the market last fall, studies of Vioxx as well as the other Cox-2 drugs suggested they had other anticancer properties as well, possibly reducing the risk of malignancies of a number of sites, including the prostate, lung, bladder and esophagus. Preliminary studies of Celebrex offered hope it might protect women from breast cancer risk by lowering levels of estrogen receptors.

This relatively new class of drugs also showed promise for forestalling the devastating effects of dementia, such as Alzheimer's disease.

Had these drugs been banished — as many pharmaceutical foes advocated — their untapped promise for prevention would have evaporated well before it was evaluated and applied to save lives. Fortunately, cooler and wiser heads prevailed.

Bravo to the FDA advisory panel for insisting benefits and risks be considered in decisions about any drug, even ones sold over the counter. Even aspirin can cause gastrointestinal bleeding, severe allergies and, in kids, potentially lethal Reye's syndrome.

The cautionary tale is that real or purported risks of pharmaceuticals must not be considered apart from the benefits. Patients in consultation with their physicians — not bureaucrats and strident self-appointed consumer advocates — should decide whether to take a drug.


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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation.

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