Would CER communications pass FDA muster? And what kind of information does the market need?
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An interesting op-ed published by Trevor Butterworth in The Daily does a great job explaining how a new federal agency could effectively bias the U.S. health care system against more innovative and effective treatments under the guise of comparative effectiveness research. The "Agency for Healthcare Research and Quality (AHRQ)," is tasked with conducting comparative effectiveness research on a variety of medicines and treatments, but isn't subject to any oversight on how it communicates the findings of that research - not even from the FDA, which strictly regulates what pharmaceutical and medical device companies can say about their products to physicians.

But is the agency likely to be a neutral arbiter of "what works?" Butterworth thinks this is unlikely:

"Imagine that all the pharmaceutical companies united to create an institute for quality research, and gave it $1 billion to study "comparative effectiveness" -- whether drugs still under patent worked better for people than cheaper generics. Imagine that the pharma companies dug farther into their pockets and came up with another $11 million to train physicians, pharmacists and nurses to be ambassadors for this institute, and that these ambassadors would travel the country offering $4 million worth of further education credits to any doctors or nurses who would agree to listen to their spiel.

If you're thinking that this is, in fact, what Big Pharma already does, remember, this is still a hypothetical exercise. In reality, such a plan would never get by the Food and Drug Administration, which is to drug marketing what the Spanish Inquisition was to heresy. But if, somehow, such a project were ever to happen, you'd seriously doubt whether it would be unbiased, wouldn't you? It strains credibility to think that the pharmaceutical industry would go to such expense to say that the cheaper drugs were just as good as the expensive ones."

For instance, out of the $1 billion the agency has been granted to conduct and disseminate its research, it plans to spend $11.6 million to recruit health care professionals to explain the results of its research to large medical practices and health care providers across the country. Another $26 million will be spent on a PR campaign to increase public awareness of the program and its work (which, btw, is already available for free on its website).

Butterworth points out two major problems with this approach. The first is that in without FDA oversight of communications, the AHRQ won't have any external check on its recommendations, which will likely be drawn from meta-analysis of many published studies - blended results which are likely to be very sensitive to small changes in methodology or background assumptions, or downplay the effect of its recommendations on subpopulations.

As a government agency, AHRQ may also be tempted to favor generic drugs and cheap treatments that lower costs in the short term, but may lead to higher costs (and worse outcomes) in the long term.

It may also underestimate the market effects of incremental innovations that will spur greater innovation (and lower costs) in the future. As Butterworth points out, "there's always a trade-off between care and cost," and while one cannot fault the government for attempting to promote cheap treatments where they can (appropriately) substitute for more expensive treatments, markets and individuals are much better at balancing these trade-offs than centralized decision makers (no matter how well intentioned).

Butterworth also points out the stark double-standard with respect to how the government regulates medical research. No pharmaceutical company could make these kinds of communications to physicians or hospitals. Efficacy claims (comparative or otherwise) that companies can make on a drug's FDA approved label are typically the result of one or more double-blind, placebo controlled trials published in peer reviewed journals. They certainly wouldn't be allowed to attack their market rivals using the type of meta-analysis of multiple studies that AHRQ will be using to drive its comparative effectiveness agenda.

America's health care system certainly needs more information to help patients and physicians make patient-centered medical decisions, and there are some studies that only the government may be big enough to fund (like cancer trials testing multiple therapies). There is also certainly a lot more evidence needed on what kinds of payment systems drive better health care outcomes. But data dredging in support of generic medicines (which already account for about 80% of all U.S. prescriptions) is both unneeded and unlikely to do any real good.

1 Comment

Restating: If we assume AHRQ is cheap, means to harm patients and is stupid, and then we give them authority to talk out loud, they will say cheap, harmful, stupid things. Also, assume an independent 501c3 is actually AHRQ.

This article is scare-mongering and is factually wrong in every way.

1. AHRQ is not in involved in comparative effectiveness. PCORI, which is, is an independent, non-profit organization with representatives from Medtronic, Pfizer, J&J, and multiple patient organizations on their board. They do not have this incentive towards cheapness.

2. Finding ways to present information in personalized, accurate ways is a primary interest of PCORI, which is very obvious on their web-site and in their first set of funded projects.

3. Your idea that meta-analysis ignores sub-populations but RCTs don't is wrong. _Any_ subgroup analysis possible in an RCT will be possible and better-powered in a meta-analysis.

4. Are you saying that pharma doesn't have money to talk to MDs? Is that a joke? The "hypothetical" that you describe as impossible is exactly the system we have right now.

5. You didn't mention how this leads to rationing at all.

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