In a long hoped for development, the FDA has moved to allow a highly promising multiple sclerosis treatment, Tysabri, to return to the market. The Wall Street Journal hopes that the agency will now move to bring Vioxx back:
Multiple sclerosis victims got some great news Monday when the Food and Drug Administration allowed a drug called Tysabri to return to market. Tysabri was pulled in February 2005 after two patients died from a rare neurological infection.
There was a possible link, since Tysabri works by modulating the immune system. But we argued from the start that withdrawal was an overreaction. And spurred by growing evidence of Tysabri's effectiveness and the pleas of many desperate MS patients, the FDA finally agreed to allow its return.
The FDA will defend the 16-month hiatus as necessary to set up a strict risk management plan to monitor Tysabri patients for signs of complications. But Tysabri had been given only under close doctor supervision anyway, and it's not likely many, if any, lives are going to be saved by the new mass of red tape. There's also no undoing the irreversible harmMS is a degenerative neurological diseasemany MS patients have suffered in the meantime.
Better late than never, we guess. And as long as the FDA is considering drug comebacks, what about the unfairly maligned painkiller Vioxx? There's new evidence suggesting it's no more dangerous to the cardiovascular system than other commonly used painkillers.
The new study, published in the British Medical Journal, is a so-called "meta" analysis of data from 138 separate drug trials involving about 140,000 patients. It found that high doses of ibuprofencommonly sold over the counter as Advil and Motrinand of the prescription pain reliever diclofenac raised the risk of adverse cardiovascular events by roughly as much as such COX-2 drugs as Vioxx and Celebrex.
We thought Merck made a mistake in withdrawing Vioxx from the market in late 2004. It's pretty clear now that Merck could have done better by patientsand avoided feeding the tort lawyer frenzy that now threatens to destroy itby merely slapping a stronger warning label on Vioxx.
The lesson in both these cases is that all drugs have risks as well as benefits. The FDA now recognizes the right of MS patients to take the small risks associated with Tysabri in order to slow the progression of their disabling disease. Those suffering from debilitating pain should also have a right to take Vioxx, or ibuprofen, if they so choose.