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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