While this debate rages, an expert review panel of cardiologists just dropped a nuclear weapon on a couple of heart disease drugs. Last year alone, consumers spent $5 billion on Vytorin and Zetia, two heart disease drugs sold by Merck and Schering-Plough. Did we get our money's worth?
Two widely prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort, a panel of four cardiologists told an audience of more than 5,000 people at a major cardiology conference on Sunday.
Instead, physicians and patients should rely more heavily on older cholesterol-lowering drugs called statins, which have proven benefits and can be cheaper, the panel said.
“The strongest recommendation we can make on this panel is to go back to statins,” said Dr. Harlan M. Krumholz, a cardiologist at Yale. “They work.”
An editorial by doctors partially funded by drug companies in the New England Journal of Medicine sounded a cautionary note, but still recommended that doctors only try the drugs in question as a last resort:
In the meantime, the thoughtful clinician may elect to adopt the following reasonably cautious strategy, which is similar to that recommended in the January 15 statement of the American College of Cardiology. First, achieve targets for levels of LDL and HDL cholesterol (or of the ratio of total cholesterol to HDL cholesterol) with the use of statins plus drugs that have shown clinical benefits when added to statins (e.g., nicotinic acid, fibrates, and bile acid sequestrants), as tolerated. Second, use ezetimibe in patients who, despite the above-mentioned therapy, do not achieve their individual targets. And third, wait for clarifying studies.
Should we be concerned?
Vytorin and Zetia are among the top-selling drugs in the world, with combined sales of $5 billion last year. About five million people worldwide, including four million Americans, take the medicines, which have been heavily advertised to consumers in the United States.
The companies responded with predictable denials:
Merck and Schering-Plough, the companies that make Vytorin and Zetia, said on Sunday that they disagreed with the recommendations. Vytorin and Zetia have been proved to lower cholesterol and are valuable treatments for patients, said Dr. Rick Veltri, vice president of the Schering-Plough research institute.
“We feel that nothing’s changed,” Dr. Veltri said.
The reason is obvious:
On Monday, shares of Merck fell $6.77 to $37.74 while Schering fell $5.07 to $14.40 at mid-day.
The stakes of the debate are high both medically and financially. The drugs produce about 70 percent of Schering-Plough’s profit, according to analysts.
Apparently, we've spent $5 billion a year on patented pills that may be worse than generics.
It's time to reform the way we pay for drugs. Take a look at Australia, where they pay for proven value, not marketing hype. I'll take up the Australian system in a future diary.
UPDATE: (April 1) The companies roll out their marketing campaign to defend their drugs:
Deepak Khanna, general manager of the Merck Schering-Plough joint venture that markets the drugs, said the companies' sales force has prepared a letter for doctors that provides the companies' view of the study presented at the conference and will provide copies of the study, called Enhance, to doctors. "Our sales force and medical-affairs group have been well prepared about what this study is and how to talk about it," Mr. Khanna said.
The companies hope to appeal to the significant number of doctors who aren't swayed by the study's findings and remain convinced their patients will benefit from Vytorin. Still, many physicians will be more comfortable operating in line with the consensus of their peers.
I'd like to see the New England Journal of Medicine compare this marketing letter with the study.