Big Pharma Attempts To Define Comparative Effectiveness Research

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"Big Pharma Attempts To Define Comparative Effectiveness Research"

prescription-drugs.jpgOver at GoozNews, Merrill Goozner flags an industry-sponsored effort to define President Obama’s comparative effectiveness research initiative. A coalition of groups who accept money from the pharmaceutical industry has sent a letter to Capitol Hill demanding “that any agencies conducting comparative effectiveness reviews be run ‘through an open and transparent process that allows for patients, providers and other stakeholders to participate equally in governance and input, starting from the research planning stage‘”:

The letter’s program is nothing less than an effort to strangle comparative effectiveness research in its cradle by giving industry the right to veto controversial inquiries and limit the scope of the research that gets done. Do publicly traded companies have a seat on the governing board of the Securities and Exchange Commission? Should we give Boeing and Airbus the right to determine the scope of the National Transportation Safety Board’s inquiry into airplane crashes? Does the current financial crisis suggest the banks should have more say over how they are regulated? Its simply bad governance to give industry a seat at the table that decides which comparative effective studies get done.

Comparative effectiveness research could save up to $700 billion annually in health spending by identifying treatments that do not produce the best medical outcomes and President Obama and Sen. Max Baucus (D-MT) want to establish an independent body that would be “responsible for setting national priorities” for head-to-head trials. But Big Pharma is seeking to define the process; an independent institute could cut into revenue for branded drugs and steer people towards more generic medications, lowering prices for consumers but cutting into industry profit.

Industry concerns aside, a comparative effectiveness institute must surely retain its independence, but generic drugs — which could certainly lower health care costs — are not without their pitfalls. As US News & World Report’s Heart To Health blog points out, “generics are far more likely to be made in factories in parts of the world like India that have cheap labor and overhead.”

According to a “scathing report issued by the Government Accountability Office in September foreign countries escape rigorous FDA inspection, documentation of their practices, and follow-up monitoring even when serious manufacturing or drug-handling problems have been identified. Worse, the GAO has identified these problems with FDA oversight in the past, and they have gone largely uncorrected—at the same time that outsourcing of generic drugs to Asia has been skyrocketing.”

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