Healthy Skepticism Library item: 16867

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Study says drug does little, proving need for more testing
The Boston Globe 2009 Nov 16
http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/11/16/study_says_drug_does_little_proving_need_for_more_testing/

Full text:

THE NEXT time pharmaceutical companies raise dire warnings about federal proposals to measure the cost-effectiveness of their products, they should be required to read the recent study in the New England Journal of Medicine about a kidney drug called Aranesp. For decades, doctors have prescribed this drug or others like it to patients with type 2 diabetes and kidney disease in the belief that the drugs would prevent heart disease and combat fatigue in patients.

The result of a randomly assigned clinical trial of more than 4,000 patients in 24 countries? Aranesp did no better than a placebo in preventing heart disease, reduced fatigue only modestly, and nearly doubled a patient’s risk of a stroke.

Dr. Marc Pfeffer of Brigham and Women’s Hospital, who led the study, said patients who are sicker than the ones in the study and already on dialysis might find Aranesp helpful and its risk acceptable. That was the kind of patient for whom the drug was designed and originally tested. But doctors began prescribing it for less seriously ill patients. Pfeffer’s study was funded by Aranesp’s maker, Amgen, in hopes of demonstrating its effectiveness on these other patients. Until now, no researchers had measured Aranesp against a placebo for such patients. Pfeffer said he was surprised at how little benefit the drug provided them.

The company pocketed more than $5 billion on Aranesp sales from Medicare alone between 2003 and 2008. Coincidentally, 15 states have sued Amgen for allegedly offering kickbacks to doctors to increase sales of the drug. Pfeffer’s study showed not only that the drug did not prevent heart attacks or deaths, but those taking it suffered 101 fatal or nonfatal strokes, compared with 53 taking the placebo.

This is the kind of effectiveness testing that the government should be sponsoring more of, with an eye toward guiding a new Medicare oversight commission with real powers over treatment decisions. President Obama’s stimulus package this year included $1.1 billion for effectiveness studies, but none of the major health reform bills before Congress would significantly expand this program. Congress should, because the country simply cannot afford to be devoting close to 20 percent of its economy to medical treatments – some of which are little better or even worse than dummy shots. When it comes to health care, the most effective investment is effectiveness testing.