Study: Comparative Data on Pharma Products Lacking from Previous Decade

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Comparative effectiveness research — the direct comparison of care interventions to determine which work best for which patients and which pose the greatest benefits and harms — has long been a pet issue for President Obama.[1

Comparative effectiveness research — the direct comparison of care interventions to determine which work best for which patients and which pose the greatest benefits and harms — has long been a pet issue for President Obama.[1] Although the theory has really never been at the forefront of his very much publicized drive for the passage of the PPACA on his terms, it is a crucial foundation for his ultimate vision of quality healthcare delivery as the ultimate method of controlling costs.

Based upon the results of a new trial in JAMA, this vision has been sorely underutilized, even with stimulus funds to expand its availability. Of the almost 200 pharma products approved by the FDA between 2000 and 2010, only 100 had comparative-effectiveness data, researchers found. Whether or not such information was available depended on several factors, including the existence of an alternative treatment and research ethics. Additionally, the availability of comparative-effectiveness data varied based on treatment area, with proportions reaching up to nearly 90 percent for diabetes medications but only 33 percent for hormones and contraceptives.

It’s the overall lack of CER data and underrepresentation of much of that data into many facets of healthcare that will keep providers ignorant of the overall effectiveness with tried and true therapies versus expensive new agents constantly hitting the pharma marketplace. Although comparative FDA data need to be expanded and enriched, it is just the beginning of the long road in giving physicians all of the information — completely free of biases — to make the most medically informed, cost-effective decisions. This study should serve as a point from which CER can be better defined, as well. | LINK

  1. The American Recovery and Reinvestment Act of 2009 allocated $1.1 billion to boost comparative-effectiveness research efforts.

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