Stimulus bill provided $1.1 billion for new research pitting therapies against each other.

A House-Senate conference committee last night settled on a provision of the stimulus package that could be critical to the biotech and pharmaceutical industry in the coming years, nailing down the details of a $1.1 billion fund for comparative effectiveness research.  This sometimes controversial research pits established therapies against one another to determine which works best and sometimes looks at cost as well. 

For the industry, the agreement represents a political defeat, as the committee adopted the House language on comparative effectiveness instead of the Senate language stressing “comparative clinical effectiveness,” with clinical being the key term. The Biotechnology Industry Organization (BIO) has long supported comparative effectiveness research that focuses on clinical outcomes, but has consistently opposed cost- or value-oriented research. 

The industry also supports comparative effectiveness research that seeks patient and provider input in research planning and allows for the fact that there is no one-size-fits-all therapy for most diseases. 

Both BIO and PhRMA (The Pharmaceutical Research and Manufacturers of America) have been represented in the legislative fight by the Partnership to Improve Patient Care (PIPC), created in November.  Its members also include a broad coalition of patient and medical groups. 

Yesterday, BIO referred media inquiries to PIPC, which did not return phone calls in time for this article.  However, an industry source familiar with the issue called the decision “a big deal for the industry because of the precedence it sets.  Will it affect coverage decisions? Probably not.  But once you open the window, it’s only going to open wider.”   With a Democratic administration and Congress, “the industry has little confidence for getting this redone.” 

This source is also concerned about coverage decisions, i.e., what therapies the Centers for Medicare and Medicaid as well as other providers will pay for underlies much of the industry’s concern about comparative effectiveness research.  The nightmare scenario may be the approach sometimes taken by Britain’s National Institute for Health and Clinical Excellence (NICE), which, for example, in 2007 said Genentech’s Avastin and ImClone and Bristol-Myers Squibb’s Erbitux “would not represent value for the money” in treating metastatic colon cancer.

NICE, which makes determinations that set policy for Britain’s National Health Service, has an established history of making such recommendations.  For U.S. government agencies, however, this is still a relatively new field. In fact, the new legislation calls for an Institute of Medicine study to help guide the research, which will be conducted by the Agency for Healthcare Quality Research and the NIH.

In one of the pilot U.S. studies of this kind, the NIH in 2002 published a study, ALLHAT,  that compared the benefits of three popular hypertension medicines. The media trumpeted the study’s findings that older, cheaper medicines trumped newer, more costly therapies in treated high blood pressure. 

Subsequent research involving 30,000 patient, however, “all had results that differed from ALLHAT findings,” according to PIPC.  The organization quotes Mark Houston, M.D., Hypertension Institute director, Vanderbilt University Medical Center, and ALLHAT investigator, as stating, “The ALLHAT study results have been misinterpreted and misquoted and are contradictory to the enormous number of scientific publications on hypertension.”   Michael Weber, M.D., from State University of New York, also an ALLHAT investigator, voiced concerns, saying the lead researchers “pushed beyond what the data allowed them to say.”

As the ALLHAT back and forth indicates, the details of comparative effectiveness research will be critical.  The legislation just finalized by Congress leaves much of those details up to the agencies.  So for the industry will have to wait and see just how important losing that little word clinical really is.


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