MS drug praised, condemned

FDA panel hears from relieved patients, kin of woman who died

March 08, 2006|By RICARDO ALONSO-ZALDIVAR | RICARDO ALONSO-ZALDIVAR,LOS ANGELES TIMES

WASHINGTON -- Multiple sclerosis patients pleaded with the Food and Drug Administration yesterday to again allow sales of a drug they called a "miracle," while the family of a woman who died taking it warned of devastating side effects.

The drug, Tysabri, was withdrawn from the market in February 2005 after three patients unexpectedly developed a rare brain infection usually seen in AIDS patients and others with very weak immune systems. Two of them died. Now the manufacturers are asking the FDA to allow Tysabri to be prescribed again, with a number of limitations on its use.

Such a reversal would be highly unusual. Because there are compelling arguments on both sides, the case is seen as particularly difficult for the FDA advisory panel that will recommend whether to resume sale of the drug.

The panel of experts is scheduled to vote today, the second day of a public hearing that has included testimony from FDA staff members, pharmaceutical company officials, patients and advocates on both sides.

Tysabri has been shown to be twice as effective as currently available drugs in preventing recurring bouts of MS, which affects about 300,000 Americans, most of whom are diagnosed between the ages of 20 and 50. It also appears to delay the overall worsening of the disabling disease.

But Tysabri, manufactured by Massachusetts-based Biogen Idec Inc. and Elan Corp. of Ireland, also has the potential to affect the immune system. About one in 1,000 patients could contract a brain infection known as progressive multifocal leukoencephalopathy, or PML. It is not easily diagnosed in its early stages and there is no effective cure for it.

According to an FDA analysis, Tysabri patients can be susceptible to other types of unusual infections.

The husband and the daughter of Anita Smith, who died while taking the drug, told the panel that the 46-year-old woman should have never been offered Tysabri because her form of MS was very mild. She could walk up and down stairs and carry loads of laundry. A doctor who has since reviewed the case for the family concurred with their assessment.

But her family said she was persuaded to enroll in a clinical trial of the drug, at least in part, by the promise of free medications. Her previous treatment had cost $1,000 a month, according to the family. From April 2002 to early 2005, Smith received 37 doses of Tysabri, which she took about once a month intravenously.

"We were never told Tysabri could result in Anita's death. If we had known that, we would have happily stayed away from the trial," said Beth Ann Smith, reading a statement for her father, Walter. The Smiths are suing Biogen Idec and Elan.

But Barbara Crooks of Irwin, Pa., told the committee that "life is all about trade-offs" and said she is willing to take a risk in order to enjoy the benefit of Tysabri again. Crooks, 48, uses a cane in each hand or a wheelchair to get around. She has had to give up her job as a medical technician. Before she became ill, she said, she played basketball and rode horses with her children.

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

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