[Ip-health] Drug Maker Stays Close to Doctors and Patients

[Joana Ramos]

http://www.nytimes.com/2008/03/16/business/16gside.html?ref=3Dbusiness

March 16, 2008
Drug Maker Stays Close to Doctors and Patients
By ANDREW POLLACK

When it comes to taking Cerezyme, its maker doesn=92t always take =93no=94 =
for
an answer.

Dr. Peter A. Kouides, a hematologist at Rochester General Hospital, said
he once had a patient with Gaucher disease who declined to be treated
with Cerezyme, a drug made by Genzyme. For years, he said, Genzyme=92s
representatives =93were always bugging us about why we weren=92t treating
this guy.=94

Most pharmaceutical makers do not even know the identities of most of
the people taking their blood pressure pills or chemotherapy drugs. But
Genzyme knows virtually everyone with Gaucher disease. And that, some
critics say, lets it influence treatment to an unusual extent and
encourage the use of high doses of its drug.

Because Gaucher disease is so rare, and because the drug is so
expensive, many patients have to come to Genzyme at some point for help
in negotiating insurance coverage or arranging other financial
assistance. The company has a staff of about 50 to help patients with
such matters.

Genzyme has also helped set up Gaucher disease treatment centers around
the country, often at academic hospitals. The specialists at these
centers usually have far more experience than the typical doctor, who
might see only one case of Gaucher disease in a lifetime. But critics
say the doctors who run these centers have become beholden to the
company and contribute to the development of treatment guidelines.

=93Genzyme wisely created their own opinion leaders,=94 said Dr. Ari Zimran=
,
an Israeli expert on Gaucher disease who has been a consultant to some
emerging competitors of Genzyme. The company has =93monopolized the
disease itself, not just the medicine,=94 Dr. Zimran said.

Three doctors who run such treatment centers said in interviews that
their financial support from Genzyme did not influence their medical
decisions.

=93If I decide not to treat someone, that=92s too bad for Genzyme,=94 said =
one
of them, Dr. Barry E. Rosenbloom, who runs the big Gaucher center in the
Los Angeles area. Dr. Rosenbloom said his center gets $150,000 a year
from Genzyme to pay for one full-time person and one half-time person,
in part to contribute data to a patient registry.

Dr. David P. Meeker, the president of the Genzyme division that sells
Cerezyme, said the company was just trying to support patients and
physicians to improve care. =93We are not here to play doctors,=94 he said.
=93We=92re not out there to advocate that patients do anything other than
what is in their best medical interest.=94

Genzyme=92s seven years of monopoly under the Orphan Drug Act, a federal
law intended to encourage companies to develop medicines for rare
diseases, expired in 2001. The company says it still has patents on
Cerezyme=92s manufacturing method that last until 2019.

But Genzyme may still face competition in the next few years, something
that could bring prices down a bit and loosen the company=92s control of
the market.

The only other drug approved in this country and overseas for Gaucher
disease is Zavesca, sold by the Swiss company Actelion. It is approved,
though, only for patients for whom Genzyme=92s drug is unsuitable.

Shire, a British company, and Protalix BioTherapeutics, an Israeli
start-up company, are in the final stages of clinical trials of enzymes
similar to Cerezyme but made in ways the companies hope will circumvent
Genzyme=92s patents. Amicus Therapeutics, a start-up in New Jersey, is in
midstage testing of a pill that works by a different mechanism.

-----------------
Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org