Published: Mar 05, 2008 06:22 AM
Modified: Mar 05, 2008 06:22 AM
In Dr. Cam Patterson's Feb. 10 column "What to do when your medicine is in the news," the doctor says there is no reason to stop taking the drug Vytorin. I find this very puzzling.
Vytorin is a cholesterol-lowering drug manufactured by Merck and Schering-Plough that combines two medicines, Zetia and Zocor. Vytorin came under scrutiny in January after efficacy data were released that showed that the drug is no better at lowering lipids (and thereby reducing bad outcomes and death) as Zocor by itself. It also costs three times more than Zocor. So why should patients continue with Vytorin?
In his fine book "The Last Surviving Patient," Dr. Nortin Hadler, a professor of medicine at UNC, provides a striking critical analysis of the effectiveness of these drugs. Best results for these drugs are attained in high-risk patients, generally those with very significant familial lipid disorders, strong family history and other risk factors (diabetes, hypertension and smoking).
Oddly, the increased risk of heart attacks in any coming year is relatively small for each risk -- perhaps 2 percent to 4 percent over the normal population per year. It turns out that severe depression is far more predictive of a heart attack in any one year than all of the above-mentioned risks together.
Further, Merck and Schering-Plough had all the data about Vytorin available in April 2006, when the study was completed. The companies claim that the complexity of analysis caused the delay in disclosure. Indeed, what was released after 20 months was only a partial analysis, and this only happened after the threat of a congressional investigation.
Can anyone imagine so long a wait if there were positive results available? The rapid emergence of positive data occurs almost magically within a few months when significant danger of a drug is revealed. Examples include the fiascos surrounding Vioxx and Celebrex a few years ago; the diabetes drug Actos just a year ago; and the problems with Zelnorm, used for irritable bowel syndrome. Indeed, one of the early lipid-lowering drugs, Clofibrate, was pulled from the market for a time after significant excess deaths occurred in three WHO studies. Oddly, it is still being sold.
All drug manufacturers routinely do extensive analyses and these should be straightforward and simple, only needing the appropriate attention of the hundreds of scientists and statisticians employed by these behemoth drug companies. There is no terrible unknown territory to scour with each new study -- they do the same general analyses over and over. If there is a need to develop special tools for analysis, that is only comprehensible to me if they are more interested in tweaking the data to a particular spin than in reporting the facts. The public is very aware of how statistics are manipulated in all fields of medicine, industry and the economy--there is little reason to imagine they feel differently about drug companies. My patients assure me of this regularly!
Nearly two years of foot-dragging on the part of Merck and Schering-Plough prior to divulging bad news has highly disturbing implications. It reinforces the nightmare of disinformation, betrayal of scientific and public trust and possible attempts to redefine the significance of the data. During this time the companies earned several billion dollars yearly on Vytorin sales.
Public welfare and interest beg a handful of questions be answered.
- If Vytorin is no more effective at best than Zocor, there is no proof of a decrease in catastrophic events or improved longevity and it costs tree times as much, why use it?
- Until there is full disclosure of all data and it has been evaluated in its statistical incarnations, why does this drug remain on formulary at UNC Hospitals?
- How many studies are being done at and how much grant money is filling the pipelines of research at UNC from the makers of Vytorin, Zetia and Zocor?
While there are many good medicines that help certain disease states, many new drugs fail to deliver on their initial claims. There is widespread public uncertainty about why they are given a particular medicine. The global concern about direct drug company influence on, and public manipulation via media advertising to influence physician prescribing habits is widely documented. In fact, these methods are wildly successful for drug companies.
The public also is fully aware of the fast-tracking of drugs by the FDA and is ever more wary of post-marketing evaluations, often at the cost of human lives, as a means of further research by the manufacturer. There can be little doubt that the high cost of medicines includes money needed to respond to class-action lawsuits.
I therefore strongly disagree with Patterson's contention that "your health care provider is almost always the best resource for understanding how news about medicines applies to your own circumstances."
In my holistic medical practice, my patients are not timid and routinely produce evidence raising strong doubts about the efficacy and appropriateness of drugs, dietary plans and a myriad of other health concerns. I am glad they do so and they know I will evaluate their concerns with them. Their concerns are human and not statistical.
In the end, the heart of the human being must be satisfied for the person striving to know him- or herself to make any important health-care decision. Only then can one put to rest the endless battles of intellect via statistics with the sensing and seeking heart and the good human will that strives to do the right thing. Only then will we meet and treat each patient with the full measure of dignity due them.
Mark Eisen practices medicine in Chapel Hill. His Holistic Family Practice is on Martin Luther King Jr. Boulevard.