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Dying Man's Suit Tests a Drug's Availability

April 27, 2003
By ANDREW POLLACK

INTERMUNE has rights to another experimental drug besides
Actimmune for idiopathic pulmonary fibrosis, and it, too,
is the focus of controversy. A man dying from pulmonary
fibrosis has sued InterMune in a California state court,
accusing it of stifling development of the drug,
pirfenidone, so it will not detract from sales of
Actimmune.

The plaintiff, Joseph L. Stendig of Bonita Springs, Fla.,
has offered no concrete proof, but he sued to force
InterMune to give him pirfenidone on a "compassionate use"
basis. Companies sometimes give drugs to patients with
fatal diseases outside of clinical trials. But InterMune
has refused, prompting Mr. Stendig to accuse it of
"shameless greed and contempt for the suffering of
patients."

Pirfenidone is not approved for any use, and there is no
clinical trial in which Mr. Stendig can enroll. But results
of a 111-patient trial in Japan were positive enough that
Shionogi, which has the Japanese rights, is applying for
approval there.

W. Scott Harkonen, InterMune's chief executive, said that
while he empathizes with Mr. Stendig, the drug has not been
tested enough. InterMune, he said, does not have access to
the Japanese data.

Dr. Harkonen said that far from stifling pirfenidone, the
company is considering a large clinical trial to accelerate
its approval. He said pirfenidone and Actimmune appear to
work in different ways and might complement each other.
"The two drugs together - there's a lot of excitement," he
said.

Many companies fear that giving out unapproved drugs makes
it harder to recruit patients for clinical trials in which
they might receive a placebo. InterMune is worried that
giving the drug to Mr. Stendig would spur demand from other
patients desperate for drug giveaways, given the Shionogi
data, according to an internal e-mail message that came to
light in the lawsuit. "This is clearly the most compelling
data to date for any drug" for pulmonary fibrosis, "even
with the tolerability issues, so demand is only going to
increase," Bill Bradford, an InterMune physician, said in
the message.

http://www.nytimes.com/2003/04/27/business/yourmoney/27SDRU.html?ex=1052536801&ei=1&en=b6201da9fde700c5

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