Healthy Skepticism Library item: 13147

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Publication type: news

Pollack A.
Drug Maker Stays Close to Doctors and Patients
New York Times 2008 Mar 16
http://www.nytimes.com/2008/03/16/business/16gside.html?ref=business

Full text:

When it comes to taking Cerezyme, its maker doesn’t always take “no” 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’s representatives “were always bugging us about why we weren’t treating this guy.”

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.

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

“If I decide not to treat someone, that’s too bad for Genzyme,” 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. “We are not here to play doctors,” he said. “We’re not out there to advocate that patients do anything other than what is in their best medical interest.”

Genzyme’s 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’s 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’s 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’s 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’s patents. Amicus Therapeutics, a start-up in New Jersey, is in midstage testing of a pill that works by a different mechanism.