Unsafe Heart Medication Peddled to Public as Wonder Drug

By Donald W. Light, Science Progress. Posted December 23, 2008.

Only a few news stories noted vaguely that Crestor itself has serious side effects. Reports to the FDA of kidney problems from patients taking Crestor exceeded reports for all other statins combined and led The Health Research Group in Washington, D.C. to recommend it be taken off the market. Crestor also lowers levels of CoQ10, a compound that helps generate energy and maintain muscle (including the heart muscle). Fatigue and weakness can result.

Moreover, the trial was stopped with 3.1 years remaining, and it is during this later period of testing when adverse side effects are most likely to surface. Running trials long enough to record benefits but too short to record adverse effects is a common practice in company-sponsored trials. It is one reason why adverse side effects are now epidemic, the 4^th leading cause of death, according to the Food and Drug Administration. As Professor Mark Hlatky at Stanford Medical School wrote in a cautious editorial, "Long-term safety is clearly important in considering committing low-risk subjects without clinical disease to 20 years or more of drug treatment."

Currently, new drugs "just have to be better than nothing."

The results of this market-driven trial were reported to the press in a way to get the public as well as the medical profession mobilized to generate large new revenues, thus making the media an agent of commercial interests. No mention was made of the fact that doctors are already prescribing statins to millions of patients to lower their cholesterol when in fact doing so does not reduce cardiovascular risk for those who have no other specific risk. The over-prescription of statins is costing everyone billions. Instead, the news emphasized how statins would now benefit millions more with low cholesterol.

The additional cost to the nation's insurers, employers, and taxpayers of prescribing Crestor to patients with CRP is estimated to be $9.0-9.7 billion. The reduction of an already small risk would cost about $557,000 per life saved, according to James Stein at the University of Wisconsin School of Medicine and Public Health. That does not include the $80 for the patented CRP test that a much larger population would first have to take, nor the costs of treating new cases of diabetes and other side effects. Yet official guidelines for doctors appear likely to change and recommend the CRP test, whose patent is held by the principal investigator of the trial and his employer, Brigham and Women's Hospital in Boston.

The main beneficiaries will be the patent-holders and AstraZeneca, the sponsor of the trial. Industry-sponsored trials are nearly 4 times more likely to produce results favorable to the sponsor's product than independently funded trials, and this one is no exception.

In order to avert future misleading claims about new drugs and to help lower the costs of health care, the country needs an organization like the Comparative Effectiveness Research Institute proposed by Senators Baucus and Conrad. Their bill, S.3408, cosponsored with Senators Jeff Bingaman, D-N.M., and Sheldon Whitehousel, D-R.I., aims to control costs by improving the effectiveness of treatments used. It would have independent funding to assess the additional clinical benefit of new tests and interventions against their costs in order to get good value for our money.

Currently, new drugs "just have to be better than nothing," according to Dr. David Barbe, chair of the American Medical Association Council on Medical Service. As Gail Shearer, the director of Consumer Reports' Best Buy Drugs website and service said, "People are ready to talk about value." The CRP-Crestor trial and bandwagon illustrates why an institute like this is a vital part of any health care reform under the new administration.

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