LINKThe family of a woman who died in February after participating in a clinical trial of multiple-sclerosis medications has filed a lawsuit against the manufacturers of the drugs.
The woman's family has sued Biogen Idec Inc. of Cambridge, Mass., and Elan Pharmaceuticals of San Francisco, claiming they knew the drug combination was dangerous.
Anita Smith died of progressive multifocal leukoencephalopathy, or PML, a rare and potentially fatal nervous-system disorder the lawsuit alleges has been linked to the drugs Tysabri and Avonex.
"Before Tysabri was approved, its manufacturers were aware that the drug's use, in combination therapy with Avonex, was dangerous," said Jerrold Parker, an attorney with Parker & Waichman LLP, the firm that filed the suit in Massachusetts Middlesex Superior Court on behalf of the family. The suit seeks unspecified monetary damages.
"This blatant disregard for patient safety caused tremendous suffering for Mrs. Smith and her family," Parker said in a statement. "It certainly appears that combination therapy was proposed by Biogen in an effort to maintain the relevance of Avonex in the marketplace following Tysabri's introduction."
Biogen spokesman Jose Juves said the company was just beginning to review the lawsuit.
"Our sympathies go out to the Smith family that this unforeseen event occurred during the clinical trial," Juves told United Press International. "When Biogen Idec was first alerted to a potential case of PML we quickly and decisively halted all dosing in clinical trials and began an extensive and still ongoing safety evaluation."
Tysabri is an immunosuppressant that was approved by the Food and Drug Administration last November. It was taken off the market only three months later, in February, after two people, including Smith, developed PML after receiving the drug.
Smith, who had participated in clinical trials of the drug in 2002, died Feb. 24, 2005. In that 2002 study, Tysabri was being combined with Avonex, another multiple-sclerosis drug manufactured by Biogen.
The drug combination may be dangerous because it can increase the average concentration of Tysabri in the body by 86 percent, the suit alleges. The high levels of Tysabri can then lead to the development of PML, the suit charges.
The suit also notes that in its review of the drug before approving it the FDA found after the sixth dose the drug combination can significantly reduce the rate of clearance of Tysabri and increase the half-life, which leads to elevated concentrations in the body. Smith had received 30 doses of the drug combination.
Biogen and Elan have acknowledged that as many as three cases of PML may have occurred in patients taking Tysabri, Juves said, but they have not yet determined if Tysabri caused the fatal condition.
"One of the things we're looking at is whether it's linked to PML," Juves said.
Parker maintained the drug does cause PML.
"There clearly is a link between Tysabri and PML when it is used in combination with Avonex," he told UPI.
Parker said he suspects more instances will be uncovered of patients developing PML after taking Tysabri. He said his firm is reviewing "several" additional cases involving Tysabri, including one patient who developed PML and one who developed an opportunistic infection. He said he may file additional lawsuits against the companies.
The companies announced earlier this week that a recently completed phase III trial showed the drug combination reduced the risk of disability progression in multiple-sclerosis patients by 24 percent and led to a 56-percent reduction in clinical relapses compared to Avonex alone.
Asked if the company planned to attempt to bring Tysabri back onto the market, Juves said, "We're going to await the outcome of our safety evaluation."