Busted: the Genentech/American Heart Association Connection

For years, Genentech Inc.'s clotbuster drug tPA has been used to treat heart attacks.

Last year, the American Heart Association published guidelines for physicians advising that tPA be used to treat strokes. Whether these new guidelines will help stroke patients or not is an open question. Whether it helps Genentech's bottom line is decided: it will.

Dr. Jerome Hoffman, professor of medicine at the UCLA Medical School, sat on the American Heart Association panel that hashed out the new guidelines. He was the only member of the panel who raised serious questions about recommending using tPA to treat strokes.

Dr. Hoffman says there is clear-cut evidence that clotbusters are helpful in treating heart attack patients. But when it comes to treating stroke, there is a great deal of controversy. While clotbuster drugs do some good in treating stroke, they also can cause bleeding in the brain.

"The Food and Drug Administration approved this drug to treat stroke on the basis of a single study by the National Institutes of Health, which I find worrisome," Dr. Hoffman said. "The study shows a marginal benefit in a very small number of stroke patients. Furthermore, I believe that study conflicts with evidence from some other studies that show increased risks with use of these drugs."

In the previous version of its guidelines, the American Heart Association recommended using clotbusters for stroke. "But they gave it a guarded recommendation," Dr. Hoffman told us. "Last fall they were reconsidering it. And a proposal had been made to upgrade it to a class one recommendation--slam dunk--definitely use it."

The American Heart Association calls itself "the largest voluntary health organization dedicated to fighting heart disease and stroke."

According to the group's 1999 annual report, it has received $1 million or more from some of the nation's largest pharmaceutical companies, including Bristol-Myers Squibb, Hoechst Marion Roussel, Novartis, Pfizer, AstraZeneca, SmithKline Beecham--and Genentech.

Curious to find out more details, we called on the Association acting science chief Dr. Rodman Starke.

Dr. Starke said that over the past 10 years, Genentech had given more than $10 million to the American Heart Association, including $2 million to build the Association's conference center in Dallas, Texas, making it one of the group's top corporate donors.

Did Genentech get anything in return for building the conference center?

"We put up a plaque inside the conference center thanking Genentech for its contribution and have allowed the company to hold a meeting of its sales reps at the conference center," Dr. Starke said.

We questioned whether Genentech's largesse created an environment conducive to the writing of guidelines calling on physicians to treat stroke with Genentech's tPA--over the informed objections of one of the panelists--Dr. Hoffman.

"Poppycock," Dr. Starke says. "There is no influence of any corporate supporters of what the guidelines are going to say. The guidelines wouldn't be any good if people would point to them and say--well these were bought."

We asked Dr. Hoffman whether he believed that the Genentech money influenced the American Heart Association on tPA.

"I don't have reason to believe that there is a quid pro quo with anyone in the American Heart Association," he said. "On the other hand, many of the volunteers on the panel have worked for drug companies, and while people who do research for drug companies often deny that this has any affect on their science, studies show it does have an effect--results tend to be better for proprietary research than for non-proprietary research."

Dr. Starke said he would get us the conflict information on the people who developed and wrote the guidelines for treating stroke. But then an American Heart Association spokesperson called us to say that the conflict reports were "confidential," and that we couldn't have them. Instead, he would set us up with a Mary Fran Hazinski, a co-editor of the guidelines. She would give us what we needed to know about possible conflicts.

Hazinski said she wanted us to know that the guidelines went through 10 or 11 layers at the American Heart Association before being released.

She said that she didn't have access to the conflict statements for all of the people involved in the process, but that she recalled that one or two of the panelists may have received a grant from Genentech.

She wasn't sure, she said, whether the people involved in the process were required to disclose any and all money--speaking fees, for example--received from Genentech. She said she didn't even know about Genentech's $10 million in contributions to the American Heart Association--until we told her--and she was writing and editing the guidelines recommending tPA for stroke.

"I think it is wonderful that I never knew about the Genentech funding," Hazinski said. "Clearly it could not have influenced me if I didn't know about it."

Anyone who knows a young doctor knows that they are showered with gifts, and trips and speaking invitations from drug companies. Drug company largesse knows no bounds.

Most doctors express astonishment that anyone would think that these gifts and trips would affect their behavior. But as Dr. Hoffman points out, there is a large literature documenting the many ways that it does in fact affect physician behavior.

"Of course it affects physician behavior," he says.

That's why he refuses to take anything--a canvas bag, a notepad, a trip to the Bahamas, or a speaking fee--from drug companies.

And so should the American Heart Association, no matter how sweet the corporate candycane.

Russell Mokhiber is editor of the Washington, D.C.-based Corporate Crime Reporter. Robert Weissman is editor of the Washington, D.C.-based Multinational Monitor. They are co-authors of Corporate Predators: The Hunt for MegaProfits and the Attack on Democracy (Monroe, Maine: Common Courage Press, 1999).

(c) Russell Mokhiber and Robert Weissman