In today's Philadelphia Inquirer and probably a number of other papers, a full page ad appeared with the following in a huge, Victory-in-Europe-WW2-is-Over!! font:
Are you taking Zetia (ezetimibe) or Vytorin
(ezetimibe/simvastatin)?
Then the following statement is made in a large bold font, smaller than the headline's but still very large (ellipsis in the original, but bolded emphasis mine):
If so, you may be worried about recent news stories questioning the benefit of these medicines ... on the basis of a single study that has generated a lot of confusion.
The font size goes down another notch with this:
In fact, ZETIA and VYTORIN have been proven to lower LDL (bad) cholesterol along with diet in multiple clinical studies involving thousands of patients. Both the American College of Cardiology and the American Heart Association agree that lowering bad cholesterol is important.
The font then goes up a notch in size once again:
All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of ZETIA and VYTORIN.
If you have high cholesterol, follow your doctor's recommendations on eating right, staying active, and taking your prescribed medicines.
The ad is signed by Richard Murray, MD, VP, External Medical and Scientific Affairs at Merck, and Robert J. Spiegel, MD, FACP, Chief Medical Officer, Schering-Plough Corp.
I cannot help but be touched by this ad. It is factually accurate, gives good medical advice about following your doctor's recommendations and taking your meds, and appeals to the authority of the very prestigious ACC and AHA.
Here's the catch. In the "Important Information" column below the above material, along with contraindications and possible side effects, the statement is made that (bold in original):
"Zetia has not been shown to prevent heart disease or heart attacks."
In which case, I'm not sure who, exactly, is "confused" by the "single study."
The ad calls for treating the number, perhaps in the hope that it is treating the patient. However, hope and wishful thinking are not the tools of science. Roy Poses provides more detail on this issue here:
As summarized by theHeart.org, they showed no statistically significant improvement in the thickness of arterial walls for patients who received ezetimibe, and no statistically significant decrease in the rates of revascularization, stroke, myocardial infarction (heart attack), or cardiovascular death in the group of patients given the drug. (The study was not big enough to have much statistical power to detect such an improvement, but the rates of all these outcomes except stroke were actually greater in the ezetimibe group.) Up until the the release of these results, no study had shown that ezetimibe produces any clinical benefit, e.g., prevents heart attacks or strokes, prolongs life, etc. And the long-delayed results of the ENHANCE trial again showed no such benefit.
I understand the rationale behind the new ad -- an attempt to keep sales of Zetia and Vytorin up to prevent yet another drug from failing in the setting of a thin pipeline of drugs ready for launch and looming patent expirations. I do not envy the difficult position these executives, trying to keep their businesses healthy, are in. However, I consider the ad to be bad spin, the kind in which politicians engage, not biomedical scentists and organizations. The real issues are:
Why should consumers and insurers spend extra on a drug like Zetia, which also can cause additional side effects, if it is shown to lower cholesterol but not shown to prevent heart disease or heart attacks, one of the major (if not the predominant) reason people take cholesterol-lowering drugs? Why "treat the number?"
I believe there is good evidence that many of the statin drugs do lower the risk for heart disease. If zetia does not, then why assume the expense and/or take the risk until meaningful clinical benefit to the patient, if any, becomes clear?
Other recent widely-publicized drug debacles have certainly given support to "erring on the side of caution."
That would seem to be the "un-confused" approach.
In fact, massive full page ads that cost a lot of money like this one may "treat the pharmaceutical company", but likely generate even more skepticism about the industry among the lay public and among critical-thinking clinicians.
I also add that the creation of a "new" drug (Vytorin) via the combination of two existing drugs (statin and ezetimibe) is likely a sign of a company trying to "do business from an empty wagon." It's regrettable when a company that had done as well as Merck in the past in creating truly "breakthrough" drugs has had to resort to such repackaging to stay financially viable.
I spent much effort at Merck to increase access to important informatics tools by drug discovery scientists to which access was rationed, an accomplishment I am proud of, but probably would not have had to perform if the industry understood the priorities for long term survival and research creativity better. This seems unlikely in a pharmaceutical industry dominated by non-scientist/clinician, quarterly profit-oriented, management fad-centric businesspeople at the helm.
Perhaps if as much resource and energy had been devoted by the pharma industry to R&D as to marketing (recent studies show a 2-to-1 overspend on the latter), and less had been spent on bureaucracy, the need for "repackaging" and "spin" by the industry would not exist - they'd be selling good drugs. And, I might still be employed in the industry, rather than part of the 4,400 laid off in 2003 when several other new drugs failed to make it into the sales wagon.
-- SS
Most post-market studies funded by industry are intended specifically to expand the market for a drug, and such studies are usually not undertaken unless the calculated probabilities indicate that the study will yield a positive financial return [1]. In approving a new drug, FDA may demand that a company conduct additional safety trials after release to the public, but the agency can't enforce these post-approval studies, which are tedious and expensive, as FDA has “limited authority to require that sponsors conduct post-market safety studies [2]. More than half of those agreed to by manufacturers never occur, according to a Department of Health and Human Services report in the March 15, 2004 Federal Register [3].
1. Preventing Medication Errors: Quality Chasm Series. Committee on Identifying and Preventing Medication Errors, Board on Health Care Services (Aspden P, Wolcott J, Bootman JL, Cronenwett L, editors), Institute of Medicine, National Academies Press, 2007 (prepublication copy), p. 238 (quoting Tunis et al., 2003).
2. Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process. p. 11, United States Government Accountability Office, Washington, D.C., March 2006, http://www.gao.gov/new.items/d06402.pdf
3. Dangerous Practices: Critics see flaws in drug-safety monitoring. Science News, Week of Feb. 5, 2005; Vol. 167, No. 6 , p. 90, http://www.sciencenews.org/articles/20050205/bob10.asp
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