The yanking from the market of both Vioxx and Bextra, members of a new generation of pain relievers called COX-2 inhibitors, has critics ripping raw flesh off the Food and Drug Administration. Inevitably, both the agency and pharmaceutical companies are under intense pressure to over-scrutinize new drugs. But over-caution can also cause tremendous pain, as multiple sclerosis sufferers using a recently-pulled drug called Tysabri can attest.
Tysabri belongs to an incredibly promising new class of biotech drugs called monoclonal antibodies. Monoclonals have repeatedly shown an ability to slow or reverse diseases for which previously there had been nothing available but pain relievers and to be effective against multiple diseases.
Such appears to be the case with Tysabri, produced in partnership by Biogen Idec and Elan Pharmaceuticals and approved for MS in late November. About 400,000 people in this country have MS, in which the immune system attacks both the brain and spinal cord and causes a host of symptoms including blindness, paralysis, and sometimes death.
There are other MS drugs, but none seem nearly as effective as Tysabri or as well-tolerated. In fact, results released this month of two years of clinical trials showed a stunning a 42 percent reduction in the risk of disability progression and an even more amazing 67 percent drop in clinical relapses.
Michael Fumento is a, journalist, and attorney specializing in science and health issues as well as author of BioEvolution: How Biotechnology is Changing Our World .
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