Prescription for Controversy

Do corporate donations to the American Heart Association influence its drug guidelines?

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When doctors prescribe medication for heart disease and strokes, they rely in large part on professional guidelines from the American Heart Association. The AHA evaluates the safety and effectiveness of new drugs that have won federal approval, and offers independent recommendations that physicians tend to follow. So when the nonprofit association gave a clot-buster medication called t-PA its highest praise last year, doctors listened.

“t-PA holds enormous potential for the treatment of ischemic stroke, which accounts for 70 to 80 percent of all strokes,” the AHA declared in its annual report in 1999. “It is estimated that t-PA could be used in 400,000 stroke cases per year to save lives, reduce disability, and reverse paralysis. Yet t-PA is now only being used in some 4,000 to 6,000 cases annually.”

But nowhere in its recommendation does the association reveal a potential conflict of interest: According to the AHA’s own reports, Genentech, the manufacturer of t-PA, has been a major financial contributor to the association. Minutes of a meeting of the AHA board of directors on October 18, 1991, indicate that Genentech donated $2.5 million to convert offices at the group’s headquarters in Dallas into a conference center. What’s more, the AHA’s latest annual report lists Genentech among 21 corporate “partners” that have each given as much as $1 million to the association. All told, the South San Francisco-based firm has given the AHA approximately $11 million for research, education, scientist development, and conferences over the past 10 years.

The AHA confirms the contributions, but insists that corporate funding has no influence on its evaluations of hundreds of drugs. Dr. Rosemarie Robertson, president of the AHA, notes that the association assembles panels of independent doctors to review drug studies and approve guidelines, requiring them to sign statements disclosing any conflicts of interest. The AHA has also given its lowest rating to at least two drugs manufactured by its corporate sponsors, saying the therapies are “unacceptable, of no documented benefit, or may be harmful.”

But many in the medical community question whether corporate money plays a role in shaping AHA endorsements. Stroke is now the third-leading cause of death. At $2,500 a dose, t-PA would earn Genentech at least $1 billion a year if the drug were used to treat 400,000 cases annually, as recommended by the AHA. “We’re being hoodwinked,” says Dr. Robert McNamara, president of the American Academy of Emergency Medicine. “The whole thing is fueled by drug company money. It leaves a bad taste in your mouth.”

In encouraging doctors to use Genentech’s clot buster, the AHA relied heavily on a single study, which found that 12 percent of stroke patients treated with t-PA showed some functional improvement. But the study found no evidence that the drug “saves lives,” as the AHA has claimed in literature it distributes to doctors and the public at large. In fact, as its own guidelines note, 6.4 percent of patients who took t-PA suffered brain hemorrhages — 10 times higher than the rate among patients given placebos. In addition, several other studies found that unless t-PA and other clot busters are administered with extreme care, patients are two to three times more likely to die than those given placebos.

Questioned by Mother Jones, the AHA decided in January to remove any language that suggests that t-PA “saves lives.” But some doctors continue to worry that the AHA’s recommendations will increase the risk to stroke victims — especially if the medication is not administered within precise guidelines. “None of the literature says that t-PA saves lives,” says Dr. Jerome Hoffman, a UCLA professor who was the lone dissenter on the AHA panel that endorsed the drug. “In fact, much of the available evidence suggests that lives might be lost if t-PA is used in stroke, particularly in everyday community practice.”

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