Get drug firms out of drug approval
The drug Vytorin has been a multibillion-dollar blockbuster -- although it hasn't exactly been the cholesterol buster it was supposed to be. Commentator and physician Dr. Stefan Kertesz says it's a cautionary tale about the process of approving new pharmaceuticals.
Stefan Kertesz (Stefan Kertesz)
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TEXT OF COMMENTARY
BOB MOON: Millions of Americans take a drug called Vytorin, which is made with another medication called Zetia. As sales go, it's been a multibillion-dollar blockbuster. Trouble is, it hasn't exactly been a cholesterol buster. Merck and Schering Plough are now acknowledging the drug doesn't prevent heart attacks. In fact, it may actually speed up clogging of the coronary arteries. Commentator and physician Dr. Stefan Kertesz says it's a cautionary tale about the whole process of approving new phamaceuticals.
STEFAN KERTESZ: This week's news that Vytorin and its sister drug Zetia don't seem to help patients and might be harmful is not just about the toxicity of yet another drug. It's about the toxic interplay of the pharmaceutical industry and the experts who write the guidelines and set the benchmarks doctors aspire to.
To see how this works, let's look back to 2004.
On July 12 of that year, the federal National Cholesterol Education Panel made an announcement: For patients with heart disease or diabetes, doctors should consider an especially low goal for bad cholesterol of 70. Not all experts agreed. A lot of us thought it would be costly and risky to "do whatever it takes, just to get the cholesterol down."
But, doctors across the country gulped, reached for their prescription pads, and then realized that a lot of patients couldn't reach the new target without a new drug. Then, 11 days later, Merck and Schering Plough introduced Vytorin.
One inconvenient fact emerged soon thereafter: Of the cholesterol guideline's nine authors, eight disclosed significant financial ties to the pharmaceutical industry, seven specifically to Merck and Schering Plough. I'm not suggesting that these experts have opinions for sale. The problem is that when data are conflicting, wishful thinking and commercial interests may supplant a rational consideration of the facts.
To protect patients we need to do two things:
We should demand entirely public disclosure of the financial ties for any expert who helps define the standards for quality in health care. And we should demand that at least some of our experts come from outside the industry, altogether.
The point is this: The science of drug development and the science of quality in health care represent two very different enterprises. If we continue to let the drug developers have such a strong hand in defining quality, we will continue to fall prey to conjecture, to wishful thinking and hype. It would be best for our health to keep these two enterprises separate.
MOON: Dr. Stefan Kertesz is on faculty at the University of Alabama at Birmingham. He asks that we disclose to you that he serves on the board of a charity that receives funding from Merck.
