February 15

RE: Stimulus Funding to Compare Treatments_Scientific American

We are pleased that Scientific American reports (below) the perspective of The Alliance for Human Research Protection about the stimulus funding for head-to-head comparison trials of treatments for the same condition.
However, we wish to make absolutely clear that AHRP does NOT take drug industry money.

Vera Hassner Sharav

Feb 17, 2009
Stimulus bill includes funding to compare drugs and treatments By Jordan Lite

Among the provisions in the economic stimulus package that President Obama signed today is $1.1 billion in federal funding to investigate how different treatments stack up against each other. The money will likely go to comparing drugs, devices and medical procedures, in an effort guided by a council of 15 civil servants.

The stimulus bill doesn't direct the 15-member council to dictate coverage.
But the council will make recommendations about what to study and coordinate research between three federal agencies: the Agency for Healthcare Research and Quality, the National Institutes of Health and the Department of Health and Human Services (HHS).

If that sounds like an obviously prudent thing to do – at a $2.2 trillion cost in 2007, health care accounts for 16 percent of the U.S. gross domestic product – you may be surprised to learn that there's really no mechanism for doing it in the U.S. There's the U.S. Preventive Services Task Force, which looks only at screening tests and other preventive measures. But many have worried that "comparative effectiveness research" risks that insurers (including government health programs) will deny coverage of treatments deemed costly or ineffective, the Wall Street Journal noted recently.

Reaction to the plan varied, although those who tend to support Big Pharma found a lot in common with those who don't. In a recent blog post at National Review, James Capretta, a fellow at the Ethics and Public Policy Center think tank in Washington, D.C., which is "dedicated to applying the Judeo-Christian moral tradition to critical issues of public policy," fretted over government's ability to handle the "nuance and subtlety" of the comparisons, adding: "Centralized government control always leads to price controls, under-funding of institutional care, arbitrary restrictions on access to new drugs and technology, and a drying up of investment in medical innovation."

And the Partnership to Improve Patient Care (PIPC), which pushes the research but takes industry money, and the Alliance for Human Research Protection (AHRP), which is one of Big Pharma's – and academic medicine's – harshest critics, share similar concerns. While both are supportive of the comparative effectiveness research concept and its inclusion in the stimulus package, the New York-based AHRP says the research will only be useful if it's not beholden to special interests.

"This has the potential for restoring integrity to medicine by providing doctors and the public with impartial risk-benefit information about existing treatments devoid of commercial bias," Vera Hassner Sharav, the group's founder and president, said in a statement. "But that goal will be realized only if the council will be entirely transparent. Not only must the results be posted on the Internet, but before the trials commence, the design of the comparison trials, including indication of the primary and secondary endpoints, the inclusion/exclusion criteria for subject selection, must be posted on the Internet for independent scrutiny."

The U.S. won't be the first to perform comparative effectiveness research.
England has the National Institute for Health and Clinical Effectiveness (NICE), which evaluates the cost and effectiveness of treatments, as do France, Denmark and Germany. While NICE guides England's National Health Service, it's been criticized for recommending against the use of drugs for certain patients with breast cancer, multiple sclerosis and Alzheimer's disease. (The UK's Cochrane Collaboration is a private effort, owned by publisher John Wiley and Sons, that serves a similar function but does not advise the government.)

"Don't we want to be spending our resources on what will improve care and what will help treatment?" Jenny Backus, a spokesperson for the HHS, told the Associated Press.

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