March 9th, 2010
04:45 PM ET
By Caleb Hellerman
When your doctor is choosing among treatments – whether it’s deciding the right drug to help lower cholesterol, or which pain medication to use when you’re lying in the ICU – you’d like to think he or she is weighing pros and cons, based on carefully compiled medical evidence. Unfortunately, that picture is far from reality.
A new study in the Journal of the American Medical Association helps to quantify the problem. The paper, by researchers at the University of Southern California, says that fewer than a third of research studies published in the most influential medical journals even look at whether a prospective treatment is safer or more effective than what’s already in use.
Some people think the FDA should require drug makers to prove that a new drug not only is effective, but that it works better than existing treatments on the market. However, in a JAMA commentary published alongside the new study, Dr. Alec O’Connor of the University of Rochester School of Medicine says that federal regulations can be interpreted to mean that the FDA is not even allowed to reject a drug’s application, as long as it works better than a placebo.
Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who has written extensively about the drug approval process, says that the results aren’t surprising and that a better system might have caught the problems with blockbuster drugs such as Avandia and Vioxx, before they came into wide use. Avandia, a drug to treat diabetes, has been linked by the FDA to more than 80,000 heart attacks. Vioxx, an arthritis medication, went on sale in 1999 but was pulled from the market in 2004 after studies showed it caused a higher risk of cardiovascular problems.
“If you’d been shown the facts about Vioxx and Avandia in Year One instead of Year Five, it would have saved a lot of lives,” Avorn says.
Study author Michael Hochman, an internist at Los Angeles County Hospital, says he was struck during his training how little research there was to guide decisions that he and his colleagues had to make every day. “Take diabetes,” says Hochman. “You have to decide what’s the first medicine to use, when to start insulin, what’s the proper blood sugar level to target, what’s the appropriate way to monitor someone’s blood sugar – when, most of the research in diabetes is geared towards the development of expensive new drugs. I wonder if we might be getting too far ahead of ourselves.”
Hochman and his co-author found that most so-called “comparative effectiveness” research is funded by universities or government agencies, as opposed to being done by pharmaceutical companies. Not only did he find that most researchers ignore established therapies, Hochman says that of the 328 studies that he looked at in the major journals, only two included a formal analysis of cost.
The findings have to be discouraging for those who support a bigger role for so-called “comparative effectiveness” in the practice of medicine. The health care overhaul being promoted by President Obama envisions a system under which vast amounts of data on different treatments would be collected and analyzed, with evidence pointing to the most helpful and cost-efficient therapies, which might also shape the decisions made by insurers and by the federal government in its role as the overseer of the Medicare and Medicaid programs. The health care bill passed by the Senate gives $165 million over three years, to a new agency, to fund and oversee comparative effectiveness research. The president’s 2011 budget includes $286 million for the same research.
Avorn says the proposed new funding is just a drop in the bucket, compared with the $2.3 trillion that Americans spend annually on medical care. “It’s just a matter of the research not getting done. The trouble is, it’s not a high priority for the pharmaceutical industry to fund a cost-effectiveness study of its new drug, if there’s a generic that’s just as good, and much less costly.”
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