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Busted: the Genentech/American Heart Association Connection


Russell Mokhiber

and Robert Weissman

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).

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