Translational medicine
More research is not the only way to increase the sway of science in evaluating medical treatments. "It's not just about doing the studies, but making sure that the studies lead to changes in doctors' practices," Hochman says. He argues that government CER funds should also be used for research that examines the best ways to translate comparative effectiveness findings into clinical practice.
Expanding CER and the adoption of its conclusions can also be improved "from a workforce training perspective," Conway says. He notes that if more researchers and doctors are trained with this aspect of medicine in mind, the patients will ultimately be better off.
Not everyone is on board with boosting CER, however. "People who are concerned about health care rationing have opposed some of the comparative effectiveness funding," Hochman points out. But the researchers and others close to the data say that this is not the goal of the field. "The goal of CER is to inform clinicians and patients," Conway notes, but often, "the message gets lost."
Highlighting some of the personalized promises of CER is another way to increase its broader appeal. Comparative effectiveness studies can not only help doctors and patients know which therapy (prescription or lifestyle changes) is most effective overall, but also, Conway says, eventually what combination of treatments are best for a particular individual. "I think CER is very in line with personalized medicine. If done well, it should actually identify which patient would benefit from which therapy," he notes.
Effecting change
Most of the comparative effectiveness research (87 percent) that the JAMA report assessed had been backed by noncommercial funding. The field currently holds little appeal for companies, which rely largely on new products to boost their earnings, and evaluating a new drug against existing ones—or nonpharmacological interventions—is risky, as a negative result would hardly be good for sales. Additionally, the researchers noted, comparative studies funded by private companies are not always as rigorous as those supported by the government or nonprofits. Pharmaceutically funded trials often test a treatment against an inactive placebo, whereas noncommercial studies are more likely to use an active, competing treatment for comparison. The authors posited that this situation that might help to explain why industry-funded research has historically been more likely to return positive results of a test drug.
But with the bulk of CER thus falling to the government and nonprofits, funding will likely continue to be a major issue.
The $1.1 billion from ARRA has been a big boost to the field. The HHR's Agency for Healthcare Research and Quality (AHRQ) received a budget increase for 2011 about 11 times greater (to $286 million) from the previous year. "I definitely think this is a good thing," Hochman says. "But it may quickly become apparent that this is not nearly enough."
Down the road, if medical cost effectiveness becomes as big a factor as many health care reform proponents have argued it should be, CER could even become a profitable line of research, the HHS's Conway notes. "The goal is to eventually pay for the value of services," he says. And if that goal comes to pass, "there should be incentives in the private sector, as well: to demonstrate that your product has a better value."
Some in this research field have proposed integrating CER into the FDA approval process—and requiring labeling of an approved product's proven effectiveness. Such a change would "improve clinicians' and the public's understanding of the role of new treatments, reduce the amount of taxpayer-funded comparative effectiveness research needed, and may even reduce health care costs," Alec O'Connor of the University of Rochester School of Medicine and Dentistry wrote in a commentary in the same issue of JAMA.
Others are also optimistic about the increasing attention to CER. "This is an opportunity to reexamine and reevaluate how we approach patient-centered research," Jean Slutsky and Carolyn Clancy, both of AHRQ, wrote in a March 8 commentary in Archives of Internal Medicine. The task might seem daunting, they noted, but "the payoff will be fantastic."
Any changes, however, are not likely to come quickly. With medical research in particular, years often intercede between study design and published findings, so even with the recent government funding increases the general public is not likely to see a flood of concrete CER findings for some time.
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6 Comments
Add CommentAnd the tax payer, not the pill builder, is paying for this inadequate information and, most often, dangerous medicines and therapies. Just getting this CER system straightened out should save the tax payer and medical bill payer billions in wasted funds. That, in a couple of years, should cover the cost of the new revised medical bill before the Senate now. Who was it that screwed up the medical system so bad like this, and when did it become this screwed up???
Reply | Report Abuse | Link to thisCER should be the function of, and in the interest of, patients, doctors and payers. Payers would include Medicare, Medicaid AND Health Insurance Companies. There are several ways that Insurance Companies should be trying to control costs besides just removing at-risk patients from their roles. One major way, is checking the effectiveness of treatments they are being billed for on behalf of insured patients. When I read articles about how the insurance companies never question bills from hospitals and doctors that are less than $15,000, I see why American Health Care costs so much.
Reply | Report Abuse | Link to thisThe sickening thing is that much of the data needed for comparison is already held within the FDA, that refuses to release it to the Country.
Reply | Report Abuse | Link to thisAlthough I think capitalism is the best economic system there is, it fails in some ways. Healthcare is one of them. The development of new drugs and therapys is driven by profits not on what is most effective. There is an enormous amount of medicines that are prescibed that have questionable merit. Good for the drug companies, not so go for patients. Of course some medicine is very effective. We could probably replace 75% of it with diet and excercise.
Reply | Report Abuse | Link to thisComparative drug studies are done everyday as part of the drug approval process, this is called Phase IIIclinical trials (Phase I is the first dosing in humans, formerly done in concentration camps inmates, then in imprisoned persons, and currently in paid volunteers). Once the drug is approved, and has found a niche in the market, pharmaceutical companies just stop investing money in that kind of studies, they are no longer necessary, and once the product is marketed, doctors themselves will find new applications for it, that sometimes are too expensive to formally develop and get HRA approval. The current situation in many medical fields is that there are so many new compounds and so many new indications, that it is often very hard finding patients adequate and willing to join clinical trials
Reply | Report Abuse | Link to thisHow can one write on this subject with no mention of the Cochrane Collaboration?
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