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By Susan Perry | Published Fri, Mar 12 2010 8:35 am
Part of the stimulus package passed last year by Congress included $1.1 billion for something called comparative effectiveness research — studies that directly compare the benefits and harms of different medications, medical devices, diagnostic tests, surgical procedures or other types of medical interventions.
That money arrived not a moment too soon, as the rather startling findings from a study published this week in the Journal of the American Medical Association (JAMA) make clear.
The authors of the study looked at all the randomized trials, observational studies and meta-analyses involving medications that had been published in six top medical journals during a recent 16-month period. Of the 328 (out of more than 1,500) studies that fit that criteria, only 104 — or 32 percent — were comparative effectiveness studies.
“The rest were either aimed at bringing a new therapy to market or simply compared a medication with a placebo,” wrote the study’s authors, Michael Hochman, MD, of the University of Southern California, Los Angeles, and Danny McCormick MD, of Harvard Medical School, in an op-ed piece in the Los Angeles Times. “Whether the therapy was better or worse than other treatments was simply not addressed.”
Why didn’t more studies try to help patients and doctors figure out which drugs are most effective? “The answer lies in the fact that pharmaceutical companies fund nearly half of all medication research, including the lion’s share of large clinical trials,” write Hochman and McCormick. “For obvious reasons, commercially funded research is primarily geared toward the development of new and marketable medications and technologies. Once these products have won approval for clinical use, companies no longer have incentives to study exactly how and when they should be used.”
Other observations from the JAMA analysis:
• Without government, non-profit, and other non-commercial sources — which funded a whopping 87 percent of the comparative effectiveness studies identified by Hochman and McCormick — we’d know even less about how drugs and other kinds of medical treatments stack up against each other.
• Only 19 percent of the identified comparative effectiveness studies (and 18 percent of all the studies) focused on safety. As Hochman and McCormick state in their study, this finding “supports concerns that commercially funded research may underemphasize safety issues.”
• A dismal 2 percent of the comparative effectiveness studies (and 1 percent of all studies) included a formal cost-effectiveness analysis.
Without such analyses, how can we know if our medical treatments are giving us the most value for our money?
In their op-ed piece in the Times, Hochman and McCormick argue that “regulatory agencies such as the Food and Drug Administration should only approve new therapies that have been shown to be at least as good as existing therapies whenever such alternatives exist.”
An alternative, they add, would be to permit pharmaceutical companies to fund, but not design, clinical trials.
“As medical science advances, clinical decision-making will only become more complex,” Hochman and McCormick conclude. “Only by expanding public funding for comparative effectiveness research can we hope to put existing medical treatments and healthcare services to their best use. Doing so would ensure that national research priorities are determined by patient needs rather than by corporate agendas.”
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