Stimulus packages are funny things, when Congress passes a big Bill, they tend to literally throw in the kitchen sink. So a Bill that starts out creating “jobs,” ends up paying for all kinds of things. Medical researchers need jobs, too.
Buried deep within the current economic stimulus package is $1.1 billion dollars for comparative effectiveness studies.
Sounds good, but the devil is in the details. The House version includes cost comparisons. The problem with cost comparisons, is the $4 dollar generic cost at Wal-Mart is always going to beat a branded drug (paying for research) on a strictly cost basis.
Congressman Henry Waxman (D., CA) stated that, "We should focus on producing the best unbiased science possible," said Rep. Henry Waxman (D., Calif.), a strong proponent of the House language.
According to The Wall Street Journal, the House version which is based on cost sent shudders through the drug and device industry.
The Senate version does not include costs, so it now all comes down to what happens in the conference committee.
A recently formed group to help bring some balance to this issue is The Partnership for Improved Patient Care, a coalition of manufacturers, patient groups, and medical societies which has been formed to help Congress understand clinical competitive effectiveness vs. cost driven comparative effectiveness.
There are many concerns about comparative effectiveness trials, including the fact that effectiveness is not the only issue; many patients suffer side effects from one medication over another and just because a medication is the same, does not make it tolerable or clinically beneficial in all patients.
Recently, Scott Gottlieb, M.D. of the American Enterprise Institute outlined problems with the House version in an Editorial in The Wall Street Journal in which the biggest flaws in the House Democratic plan are not just political, they are scientific.
Key comparative medical questions usually hinge on when doctors should escalate care to include more invasive measures — not on bare comparisons between otherwise similar technologies, which is the focus of the House proposal.
Dr. McClellan, the former Medicare Chief, said effectiveness research can be useful but should not assume pricy medicines are automatically bad. "The goal isn't to avoid expensive drugs, it's to get more value for our health-care spending."
Competitive effectiveness research will happen, let us hope it does not hinge on a fire sale approach to medicine.