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Subscribe To Our Syndicated NewsExperts Highlight Flaw in Tysabri Drug Trial
-March 3, 2006
Stanford University School of Medicine neurologists question the flaws in a multiple sclerosis (MS) drug trial after a participant died from a rare infection linked to the drug.
Anita Louise Smith, diagnosed with early MS, enrolled in the experimental Tysabri study in 2002, hoping to decrease her chances of being destroyed by the disease. However, three years later, Smith died at the age of 46 when she developed progressive multifocal leukoencephalopathy (PML), a dangerous infection associated with the use of Tysabri.
Researchers immediately stopped the trial after two more cases of PML emerged and the Food and Drug Administration, just three months after approval, ordered Tysabri maker, Biogen Idec and Elan Corp., to withdraw the drug from the market.
New research this week, however, proved Tysabri to be safe and effective for short-term use and the FDA will meet next week to consider allowing the drug's return to the market.
Stanford experts, Annette Langer-Gould, MD, and Lawrence Steinman, MD, argue about the controversial drug in this month's issue of The Lancet. In their article, Langer-Gould and Steinman question the appropriateness of drug testing on people who show no signs of a disease and who are not disabled during the onset of the trial.
This was the case with Smith, who was diagnosed with MS, but showed no symptoms. In fact, it was determined that she never had the disease. "MS is a notoriously difficult disease to diagnose," Steinman said.
Langer-Gould and Steinman argue that people with no disability should not participate in a clinical trial because the benefits are few if nothing is physically wrong with them.
"One needs to reexamine the justifications for putting someone on an experimental MS drug when they have no disability," Steinman said. He added that an entire reevaluation of the criteria for drug trial participants is needed.
Tysabri was developed for the treatment of MS, a disease in which the immune system attacks the nerve cells resulting in loss of motor control and potential paralysis. Tysabri showed a lot of promise during the initial clinical trials as it blocked the entry of immune cells into the nervous system. However, the effects of the drug make users more susceptible to infections like the deadly PML.
While both Langer-Gould and Steinman don't think Tysabri is any more effective than other, safer MS drugs, they believe the FDA should put the drug back on the market.
They argue that a drug that has a known death risk should only be available to patients who suffer serious disabilities and only after all other options have been exhausted. This is the opposite of what happened in the Tysabri drug trial that led to two deaths and one serious injury.
"I'd like to have this drug as an option for patients who are sicker," Langer-Gould said. "We have so little for these patients. If nothing else is working, Tysabri might be worth a try. At that point in their disease, there is nothing to lose."
In the event that Tysabri is once again made available to patients, experts agree a strong warning should alert medical professionals and consumers of the serious risks.
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