14 DAY TRIAL // Tysabri has been withdrawn from the market on February 2005 after 3 patients got a rare brain disease, often found in AIDS patients, and some had their immune system weakened, 2 dying from the side effects. Now, multiple sclerosis patients are urging officials in charge of approving the drug to allow the sale, because it is 'a miracle' for the disease, this while a woman who took the drug experienced shocking side effects.
The manufacturers are asking that Tysabri be released again, with certain limitations on its use. The drug proved to be two times more effective than any other available drugs against multiple sclerosis, disease which affects 300,000 Americans. But Tysabri also affects the immune system; 1 in 1000 patients may contract a brain infection known as multifocal leukoencephalopathy, for which there is no known cure.
The case is particularly difficult, considering the convincing arguments from both sides. Experts are scheduled to vote today on Tysabri's situation, after hearing testimonials from patients, pharmaceutical companies and lawyers. Among the hearings, the husband and daughter of Anita Smith, who died because of the drug, spoke.
They stated that the drug should have not been offered because she suffered from a mild form of sclerosis, argument sustained by their doctor. They added that she was persuaded to join a clinical trial of the drug, being promised free medicine. From April 2002 to the beginning of 2005, she received 37 doses of the medicine, taken once a month, by intravenous infusion.
Tysabri was approved in 2004, after tests revealed that it prevented immune cells from attacking the nervous system. Doctors now believe that it also prevents the cells which fight the infection from reaching places where they are needed. If the drug is re-approved, doctors will be advised not to prescribe it to those taking other medication that could suppress the immune system.