Vytorin Support Statement Raises Questions Over American Heart Association FundingJan 24, 2008 | Parker Waichman LLP
Vytorin appears to have an important ally. One day after news broke that a study had shown Vytorin to be ineffective in preventing clogged arteries, the American Heart Association rushed to the drug’s defense. But the American Heart Association’s statement supporting Vytorin left out one important fact – the organization receives substantial financial support from Vytorin makers Merck and Schering-Plough. The revelation has led some to question the American Heart Association’s relationship with the pharmaceutical industry.
Vytorin is a combination of cholesterol lowering Zetia and the statin Zocor. The point of the ENHANCE study was to determine how well Vytorin prevented clogged arteries by reducing the formation of plaque. ENHANCE focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor. Vytorin did not provide any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries. Overall, the study failed to meet its primary goal, which was to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck.
Such plaque buildup is a major risk factor for heart attacks and stroke. Many doctors had been prescribing Vytorin on the theory that the drug would reduce this risk in people with high cholesterol. The ENHANCE study was a serious blow to this theory.
But the American Heart Association says Vytorin is still a good bet. In a statement issued on Jan. 15, the day after the report’s release, the heart association said the study was too limited to draw conclusions about Vytorin’s ability to reduce heart attacks or deaths compared to Zocor alone. The group advised patients not to abruptly stop taking it without consulting their doctors. There was no mention of the $2 million per year contribution that Merck and Schering-Plough makes to the American Heart Association. Dr. Daniel W. Jones, the president of the American Heart Association, who was quoted in the Vytorin support statement, told the New York Times on Wednesday that his group did not typically mention its drug company sponsors when issuing news releases with advice to patients.
Lots of people think the American Heart Association should have noted Merck and Schering-Plough’s financial support. Among the critics are several law makers. According to the New York Times, the House Energy and Commerce Committee today sent letters to the American Heart Association and Merck/Schering-Plough asking about their relationship.
The American Heart Association isn’t the only organization to have received cash from the Vytorin makers. The American College of Cardiology, a much smaller group, also receives drug industry money and also released a statement last week advising patients not to stop taking Vytorin without consulting their doctors. The American College of Cardiology is also going to be hearing from the House Energy and Commerce Committee.
Both organizations told The New York Times on Wednesday that the industry financing had nothing to do with their statements, which they said they issued in response to public confusion about the meaning of the Vytorin study. Merck and Schering-Plough also said it had played no role in the statements by the two groups. But many people are finding it hard to believe that the drug maker’s gave away millions without expecting anything in return.