BMJ analysis reveals widespread publication/selection bias in research
Filed under: Conflicts of interest, Government, Health data
Reporting on a study released by BMJ and characterized as an almost existential threat to the medical research system by Dr. Harlan Krumholz, the Milwaukee Journal Sentinel’s John Fauber writes that “Drug research, even from clinical trials sponsored by the federal government, routinely is suppressed, harming patients and increasing health care costs.” The emphasis is mine, the strong language Fauber’s.
The conclusions are based on a survey of meta-analyses of individual participant data, which the authors broke down by data source characteristics and publication status. The work is heavy on statistical analysis, but even lay readers can understand the broad strokes of what appears to be a widespread issue.
Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug’s maker, GlaxoSmithKline, to turn over the data.
And it isn’t just pharmaceutical companies’ financial concerns driving the suppression, Nissen and his coauthors found. At that point, it may more of an issue of confirmation bias and other problems which have always lurked within academic research.
A surprising finding in the BMJ analysis was that serious lapses occurred even in clinical trials funded by the National Institutes of Health.
That research showed that less than half of NIH-funded clinical trials were published in a medical journal within 30 months of the completion of the trial and after 51 months, one-third of trials remained unpublished.
Reports shed light on FDA oversight problems
When we talk about FDA oversight, what might we mean? Not too much, according to a pair of new reports from the Office of the Inspector General in the Department of Health and Human Services.
One report assessed the process by the FDA’s Center for Drug Evaluation and Research for selecting information technology contractors and monitoring their performance between fiscal years 2004 and 2007. The findings: CDER’s actions demonstrated “limited IT planning and increased risk for the government” by using broad language and relying primarily on acquisition methods that emphasize speed and flexibility over planning. CDER also used quality assurance and monitoring plans inconsistently. For instance, 21 of 28 ‘contract actions’ didn’t have documented quality assurance plans. And of seven contract actions that did include quality assurance plans, three contained identical plans with generic language, no pun intended, for inspections.
A second report, which got some notice earlier this week, found that oversight was lacking of financial conflicts of interest involving clinical trial investigators. For instance, only one percent disclosed at least one financial interest, and this represented 206 of the 29,691 investigators listed in financial interest forms. Of the 206, almost all disclosed only one financial interest, with a few disclosing two or three.
A few other problems - the FDA can’t determine whether sponsors have submitted financial info for all clinical investigators; 42 percent of FDA-approved marketing applications were missing financial info; the FDA didn’t document a review of any financial info for 31 percent of marketing applications, and neither the agency or sponsoring drug makers took action for 20 percent of marketing applications with disclosed financial interests. And when the FDA did action, the agency was inconsistent.
And how did the FDA respond? The agency told the OIG that the extra effort to collect such info “would not be worthwhile because financial interests are only one form of potential bias and not all clinical trials are presented in the marketing applications. That may be true, but the FDA is slow to realize that bias among investigators similarly may pose perceived or real problems.
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