An FDA panel did the right thing yesterday in recommending that multiple sclerosis (MS) drug Tysabri be put back on the market.
The drug, which reduces relapses in MS patients, slows progression of the disease, and often improves symptoms of many patients who are not helped by other therapies, was withdrawn by co-marketers, Biogen-Idec and Elan in February 2005 after three patients developed a rare and usually fatal brain infection called progressive multifocal leukoencephalopathy, or PML. Two of the patients died as a result of PML, which was thought to be caused by Tysabri. The drug's immunosuppressive effect -- inhibiting the overactive immune system, which attacks the brain tissue in MS -- is likely the cause of the PML infection, although the patients who were stricken were on other immune-system suppressants at the same time.
In recommending the drug be made available again -- this time with clear warnings -- the independent panel of experts advising the FDA implicitly acknowledged that there are risks and benefits associated with all pharmaceuticals.
As I wrote in a letter published in the New York Times after the drug was withdrawn, "Tysabri may indeed have a small risk of serious side effects. There are risks associated with all drugs. But it is unfortunate that patients are no longer able to consult with their doctors and make informed decisions about whether Tsyabri's risks are outweighed by its enormous benefits." If the FDA heeds its panel's advice, as it usually does, patients will once again be able to consult with their doctors about whether or not to use Tysabri.
Notwithstanding the (mostly plaintiff-bar-generated) controversy over Cox-2 inhibitors such as Vioxx and Celebrex the same calculation should apply. Weigh the individual risks versus the individual benefits, given the patient's profile. For instance, there is no evidence that justifies depriving patients with a low risk of heart disease of the painkilling benefits of short-term Vioxx use.
Despite the good news about Tysabri's likely return, it is sadly true that in this litigious, anti-Big Pharma age, the area of discretion left to doctors and patients is shrinking. The more precautionary approach called for by some anti-pharmaceutical activists pays little or no attention to the best interests of patients.
Jeff Stier, Esq., is an associate director of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).
