and Robert Weissman
years, Genentech Inc.’s clotbuster drug tPA has been used to treat heart
year, the American Heart Association published guidelines for physicians
advising that tPA be used to treat strokes.
these new guidelines will help stroke patients or not is an open question.
Whether it helps Genentech’s bottom line is decided — it will.
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.
Hoffman says there is clear-cut evidence that clotbusters are helpful in
treating heart attack patients.
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.
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."
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."
American Heart Association calls itself "the largest voluntary health
organization dedicated to fighting heart disease and stroke."
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.
to find out more details, we called on the Association acting science chief 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.
Genentech get anything in return for building the conference center?
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.
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.
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."
asked Dr. Hoffman whether he believed that the Genentech money influenced the
American Heart Association on tPA.
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."
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.
said she wanted us to know that the guidelines went through 10 or 11 layers at
the American Heart Association before being released.
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.
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.
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
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.
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
course it affects physician behavior," he says.
why he refuses to take anything — a canvas bag, a notepad, a trip to the
Bahamas, or a speaking fee — from drug companies.
so should the American Heart Association, no matter how sweet the corporate
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).