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Wednesday, September 11, 2013

Biogen Idec, Elan facing suits over MS drug side effects

New lawsuit rekindles controversy over rare brain disease linked to multiple sclerosis therapy - Business - The Boston Globe

Despite living with multiple sclerosis since 1997, Kimberley A. Yout kept a busy schedule, working full time as a money manager for a Boston bank and modeling in her spare time.

That changed on Aug. 28 of last year when Yout, 45, was diagnosed with a rare brain infection that developed as a side effect of Tysabri, a drug she took for six years to keep her MS in check. Yout’s speech became slurred, her gait unsteady, and her future uncertain.

“I was a very successful businesswoman,” said Yout, who lives in Hanover. “Today, I can’t even balance my checkbook, I can’t use an ATM, I can’t see out of one eye. I had to move back in with my mother. I’ve lost my independence. I’ve lost everything.”

Now, she is suing the two companies that marketed Tysabri — Biogen Idec Inc. of Weston and the Irish drug maker Elan Pharmaceuticals Inc. — in Middlesex Superior Court in Woburn. Her complaint, filed Friday, alleges they failed to adequately warn patients of the risks some face from prolonged use of Tysabri.

The lawsuit is one of at least a half-dozen pending in Massachusetts and federal courts in three other states. In each case, plaintiffs are seeking more than $1 million in punitive damages from Biogen Idec and Elan on behalf of patients or their families. After taking Tysabri, the patients developed progressive multifocal leukoencephalopathy, known as PML, an infection of the brain’s white matter that can cause death or severe disability.

Many doctors consider Tysabri highly effective in slowing the progression of relapsing forms of MS, a neurodegenerative disease, in adults for whom other drugs have stopped working. That’s why many of them take it, despite the risks.
Biogen Idec has been working to move beyond nearly a decade of controversy over Tysabri. Last year, it altered the drug’s label to include new safety information and introduced blood tests to help doctors identify patients’ risk level for PML. But the new suit and those pending are again raising questions about the drug’s safety.

Tysabri was approved by the Food and Drug Administration in 2004. But Biogen Idec and Elan pulled it from the market in 2005 after several PML cases, two of which resulted in death. The companies reintroduced the drug in 2006, with the approval of regulators, along with a “risk management” program that trains physicians prescribing Tysabri and requires them to monitor patients monthly under strict guidelines.

The approval for Tysabri, despite its chance of causing brain infections, was not unique. Regulators sometimes allow potentially dangerous drugs on the market if the disease they seek to ameliorate is severe, and they determine the benefits outweigh the risks.

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