Healthy Skepticism Library item: 16158
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
Dixon K.
US House panel limits comparative medical studies
Reuters 2009 Jul 30
http://www.reuters.com/article/rbssHealthcareNews/idUSN3043148420090730
Abstract:
- Committee backs curbs on comparative effectiveness
- Move would not let studies be used to deny treatment
Full text:
A panel of U.S. lawmakers voted on Thursday to prohibit the federal government from “denying or rationing” medical care based on studies comparing medical drugs and devices.
The U.S. House of Representatives Energy and Commerce Committee passed the Republican-sponsored amendment, despite objections from Democrats. It is a potential win for drug and medical device makers, which argue that such comparison studies could favor cheaper treatments.
The panel is debating its version of legislation winding its way through Congress to overhaul the $2.5 trillion healthcare system, aimed at expanding coverage and cutting costs.
The current House bill sets up a federal center for comparative effectiveness research.
“Alarmingly the bill has no restrictions on how the federal government can use this research,” said Republican Michael Rogers of Michigan, the amendment’s sponsor.
“Comparative effectiveness research is about general average assumptions,” not about individuals seeking unique treatment, he said.
House Energy and Commerce Committee Chairman Henry Waxman and several other Democrats objected to the amendment, but then let the amendment pass on a voice vote without taking roll-call. Democrats hold a majority on the panel.
Backers of comparative effectiveness, which include insurers and large employers, say the government-funded research is crucial for learning which treatments work best because manufacturers have little incentive to compare their products with those of competitors.
Currently, drugmakers must only test their new products against a sugar-pill placebo to win U.S. approval. Drug companies, devicemakers and others also do not have to compare their treatments with other options, such as surgery.
The medical product industry contends that comparative effectiveness research will favor older, cheaper therapies and that the results could be used to deny insurance coverage for newer, more expensive treatments.
The Senate is expected to include comparative effectiveness language in its healthcare reform bill. One key senator, Finance Committee Chairman Max Baucus, backs establishment of a nonprofit corporation for the research, but it would be barred from issuing medical practice guidelines or coverage recommendations for insurers.
Later today, the House panel will consider a highly watched amendment that would give biotech drugmakers 12 years of marketing exclusivity, free of generic competition.
