When Do Doctors Discount Clinical Trial Results?

by Jonathan J. Darrow

A research study reported today in the New England Journal of Medicine found that physicians are able to discriminate between clinical trials with high levels of rigor versus those with low levels of rigor, as well as between clinical trials that are funded by industry and those that are funded by the government.

The randomized study analyzed the responses of 269 physicians who were presented with hypothetical abstracts of clinical trial findings for three hypothetical drugs.  Abstracts were deliberately crafted to reflect three levels of clinical trial rigor (low, medium, and high), and three types of funding disclosure (no disclosure, National Institutes of Health funding, and pharmaceutical industry funding), yielding 27 abstract types.

The major finding of the study was that physicians are less willing “to believe and act on trial findings, independent of the trial’s quality,” if the trial is funded by industry.  That industry funding led to a decrease in perceived credibility, even for large and well-designed trials, concerned the study authors, who felt that “[t]he methodologic rigor of a trial, not its funding disclosure, should be a primary determinant of its credibility.”

The full article citation is: Aaron S. Kesselheim et al., A Randomized Study of How Physicians Interpret Research Funding Disclosures, 367(12) New Eng. J. Med. 1119 (Sept. 20, 2012). Available here.

[Editorial Note: And within the et al. is Chris Robertson, a former Petrie-Flom Academic Fellow, current prof at University of Arizona, and future guest blogger here at Bill of Health!]

Evidence for Policy: Nice If You Can Get It

By Scott Burris

Sometimes researchers can tell policy makers pretty confidently what public health law interventions really make a difference. The PHLR website has more than 50 Evidence Briefs that summarize the results of systematic reviews of the evidence on interventional public health laws conducted by the Cochrane and Campbell Collaboratives, and the Community Guide to Preventive Services.. We know, for example, that  there is significant evidence to support water fluoridation as an effective public health intervention aimed at reducing tooth decay (Portland, are you listening?). We know that workplace smoking bans prevent heart attacks. For laws like these, we have numerous high quality studies, sometimes even experiments, that show whether or not the law is effective.

Unfortunately, problems don’t wait for evidence, and usually by the time there is a substantial body of evidence in place to review, most states have already made their policy decisions. What do we do when there is a problem that demands action, but there is no clearly effective legal action to take?

One of these days we’ll blog about what we think should happen. But for now, we can look at what often does happen. Usually, it resembles the fads we see in fashion: One state tries something, and other states follow, until a lot of states are doing something that might, or might not be working.

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MA Health Reform and Medical Debt – Getting the Facts Straight

by Rebecca Haffajee 

Earlier this week, the Boston Globe reported that medical debt is still a problem in Massachusetts, with scant change since the implementation of health reform legislation in 2006. Specifically, the article reports that of approximately 3,000 adults surveyed in 2010, 17.5% had trouble paying medical bills in the past year and 20% were carrying medical debt and paying it over time, statistically insignificant changes since 2006. The source of this finding is the Massachusetts Health Reform Survey (MHRS) funded by Blue Cross Blue Shield of MA Foundation, whose latest results published in January 2012 track annual trends from 2006 – 2010. The Globe story seems to suggest that in the absence of reductions in medical debt, health reform is failing to achieve one of its goals. The survey findings, however, don’t present a story of causal inference; they (at best) identify a loose association.

Just to recap some basics of MA health reform: the law required most residents to obtain insurance. It established Commonwealth Care through the Health Connector – an exchange of sorts – so that low income residents not eligible for Medicaid could qualify for a subsidized plan.  The Connector also offers Commonwealth Choice non-subsidized plans for individuals and employers.  Since passage of the law, insurance coverage among MA residents has increased from 94% to 98%.

The MHRS study design consists of 1 “pre” measurement, or the survey fielded in 2006 just before reform implementation, and 4 “post” measurements (2007-2010).  This design fails to provide a reliable counterfactual that reveals what would have happened in the absence of the health reform “treatment”.  A slightly better design would have administered survey questions for many years before health reform implementation. But even this design would be considered somewhat weak for causal inference given the presence of other factors that could have happened concurrently with the policy change that could explain outcomes. For instance, the recession could dramatically impact how much medical debt is incurred or not paid off, even with health insurance — especially with the proliferation of high deductible health plans in recent years.

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FDA Law: More Statutes Than Regulations?

By Katie Booth

The FDA Law Blog has just published a semi-serious study by Kurt Karst on the growth of Title 21 of the United States Code (“USC”) compared to Title 21 of the Code of Federal Regulations (“CFR”) over the past twelve years. Title 21 governs food and drug law. Karst used the PDFs of the USC and CFR available on the Government Printing Office website to compare the number of pages in the USC and CFR from year-to-year. A graph of his results is available on Karst’s post, “The Obesity Epidemic: FDA’s Growing Waistline!

Unsurprisingly, Title 21 of both the USC and the CFR grew in length between 1999 and 2011. More interestingly, however, the USC grew by 50% while the CFR grew by only 10%. If the purpose of regulations is to interpret and flesh out statutes, common sense would suggest that food and drug regulations would grow at a greater rate than food and drug laws (or at least at the same rate). Karst’s explanation for his findings is that the “FDA has been issuing far fewer regulations, and instead, has been implementing the law through guidance and other policy documents.”

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The Evolution of Public Health Law Research

By: Scott Burris, JD

Law has been used to protect and promote public health from the early days of European colonization of North America. Quarantine statutes and orders are reported from the mid-17th century. The 1793 yellow fever epidemic in Philadelphia, where our office is based, inspired the federal government’s first public health statute, authorizing relocation of the capital in the event of an outbreak.

By the mid-19th century, sanitarians like Boston’s own Lemuel Shattuck were articulating the idea that a considerable proportion of death and illness was preventable, and arguing that it was moral, feasible, and economical for the state to do the preventing. Law was a primary tool for prevention, and throughout the 19th century, and into the early twentieth, the extent and limitations of federal, state and local public health authority was litigated, debated in legislatures and defined in voluminous treatises by scholars like Freund, Tiedeman and Tobey.

And then, it got quiet.

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Broadening “Innovation Law & Policy” (and “Human Subjects Research”)

By Michelle Meyer

In legal scholarship and education, innovation law and policy is virtually synonymous with intellectual property in general, and with patent law in particular. This is curious and, I think, misguided. We expend considerable effort designing optimal incentives for innovation. We expend similar effort ensuring that socially useful knowledge, once produced, is widely and accurately disseminated. But if knowledge-producing activities themselves are suboptimally regulated, neither upstream incentives to engage in them nor downstream mechanisms to disseminate their fruits will much matter.

In Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, I

critically examine[] that regulatory framework, adopted by more than one dozen federal agencies in the U.S. and many other countries, which governs the vast majority of those knowledge-producing activities that have the greatest potential to affect human welfare: research involving human beings, or “human subjects research” (HSR). [The Article] focuses on the primary actors in the regulation of HSR — licensing committees called Institutional Review Boards (IRBs) which, before each study may proceed, must find that its risks to participants are “reasonable in relation to” its expected benefits for both participants and society. It argues for a particular interpretation of this risk-benefit standard and, drawing on scholarship in psychology, economics, neuroscience and other fields, argues that participant heterogeneity prevents IRBs from carrying out their regulatory duty. Instead, the regulatory system implicitly responds to the heterogeneity problem with risk aversion that is costly not only to researchers and society but, critically, to would-be research participants. The Article concludes by laying out the policy options that remain in the wake of the heterogeneity problem’s intractability: continuing the legal fiction of risk-benefit analysis, honestly embracing the heterogeneity problem and its costs, or jettisoning IRB risk-benefit analysis. A companion Article develops the possibility of the third option.

HSR is not, of course, unknown to the legal academy. Read More