Judge orders Biogen to turn over MRIs in Tysabri case

The Boston Globe Judge orders Biogen to turn over MRIs in Tysabri case
The Boston Globe,
February 25, 2006.

by Jeffrey Krasner, Globe Staff

A Middlesex Superior Court judge yesterday ordered Biogen Idec Inc. to turn over MRI images of Anita Smith, a Colorado woman who died of a rare disease while participating in a clinical trial of Tysabri, the company's multiple sclerosis drug.

Smith's widower, Walter Smith of Colorado Springs, Colo., last year sued the Cambridge biotechnology company and its partner, Elan Corp., for wrongful death, alleging Anita Smith didn't actually have MS when she was enrolled Into a trial of Tysabri in combination with another drug, Avonex.

The ruling by Judge Julian T. Houston after a brief emergency hearing compels Biogen Idec to permit a Colorado medical imaging firm to release three MRIs of Anita Smith's brain. The first one, taken in March 2002, could show that she wasn't suffering from MS.

"We're delighted by the court's prompt entry of this order, which will greatly facilitate the Smith family's quest to determine the truth regarding the circumstances of Mrs. Smith's death in February 2005," said Jason Mark, an attorney at Parker & Waichman of Great Neck, N.Y.

The release of the MRI could be a factor in Biogen Idec's campaign to return Tysabri to the market. Biogen Idec and Elan pulled the treatment off the market in February 2005, three months after it went on sale following an accelerated approval process by the Food and Drug Administration.

The companies identified two people who had contracted progressive multifocal leukoencephalopathy, a rare brain infection most often seen in HIV patients, and halted sales and clinical trials. Smith died and the other patient recovered. A company investigation found a third patient who had PML. That patient died while participating in a European trial of Tysabri as a treatment for Crohn's disease. No further cases were discovered during an extensive safety review last year.

Now, Tysabri's return seems imminent. The FDA last week gave the company permission to restart clinical trials. On March 7 and 8 an FDA advisory committee will consider allowing the drug back on the market. Dozens of MS patients and advocates are expected to testify in favor of letting Tysabri return. While existing treatments, including Biogen Idec's Avonex, merely slow progress of the disease -- which causes a wide variety of debilitating symptoms -- Tysabri showed a strong ability to prevent crippling flare-ups.

Walter Smith also plans to testify at the hearings. But according to his lawyers, he will argue for restricting access to Tysabri. "Mr. Smith is opposed to the return of this potent and potentially dangerous drug to the market without profound safeguards and security measures in place," said Alex H. MacDonald, an attorney at Robinson & Cole LLP, which is also representing the Smith family. "Among his major concerns is the use or prescription of Tysabri to patients -- like his late wife -- who may not, in fact, suffer from MS." Tim Hunt, a Biogen Idec spokesman, said, "Multiple sclerosis is a clinical diagnosis. As a standard practice, in our trials, we rely on trained neurologists who are clinical investigators to determine if their patients meet the eligibility requirements."

The New England Journal of Medicine in June published articles examining Tysabri and PML. Some neurologists continue to study the drug and the related PML cases. In an issue of the British Medical Journal published last week, neurologist Abhijit Chaudhuri wrote of Anita Smith's case: "Because the pathology did not support the clinical diagnosis of multiple sclerosis in the fatal case, the diagnosis is questionable, and the decision to enroll an atypical patient is debatable."

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