Why a lot of important research is not being done

December 4, 2017

Why a lot of important research is not being done

The New York Times - The Upshot

We have a dispiriting shortage of high-quality health research for many reasons, including the fact that it’s expensive, difficult and time-intensive. But one reason is more insidious: Sometimes groups seek to intimidate and threaten scientists, scaring them off promising work.

In 2013, scientists at the Food and Drug Administration published a study in The Journal of Pharmaceutical and Biomedical Analysis showing that nine brands of dietary supplements sold in the United States contained a synthetic analogue of amphetamine. The authors noted that the efficacy and safety of this stimulant, β-methylphenylethylamine (BMPEA), had never been studied in humans.

A year later, Canadian health authorities recalled supplements containing the stimulant, noting the potential for “serious cardiovascular complications.” The F.D.A., inexplicably, remained silent. The agency did not warn the public, recall products or warn manufacturers.

Dr. Pieter Cohen, an associate professor of Medicine at Harvard Medical School, replicated aspects of the 2013 study and came to the same conclusion as the F.D.A. experts: The stimulant was available in multiple brands of supplements, and a comprehensive review of the biomedical and chemistry literature found not a single scientific study of the stimulant’s efficacy or safety in humans. These results were published in Drug Testing and Analysis in 2015 and widely disseminated by national and international media outlets. Two weeks after that, the F.D.A. alerted consumers that the stimulant was potentially dangerous and warned manufacturers to remove it from their products.

IHPI member Nicholas Bagley, a law professor at U-M, recently wrote in JAMA Internal Medicine about the damage such suits inflict on scientific inquiry. We pointed out that the peer-review process already provides a way to question a study’s conclusions before publication, and that less formal peer review continues afterward in the form of letters to the editor and editorials.

If errors or mistakes are believed to be fraud, mechanisms for review exist in university systems. Only if evidence of fraud surfaces does it make sense for courts to be brought into play.

“Courts aren’t equipped to referee scientific disputes,” Mr. Bagley said. “And they have an obligation to prevent unscrupulous plaintiffs from abusing the machinery of justice to stifle science.”

Lawsuits like these are too common in health research. Mr. Bagley did a fairly comprehensive search of the reported opinions over the past 40 years. He found two cases in the 1980s and two in the 1990s. Since 2000, however, there have been 10. These numbers greatly understate the number of filed cases, however, since the vast majority are settled.

The manufacturer of a hip protector sued a researcher in 2008 over a study published in JAMA that showed the device didn’t prevent fractures. The C.E.O. of a pharmaceutical company sued a researcher who led his data monitoring committee when the researcher published a 2011 article in Annals of Internal Medicine disputing the way the C.E.O. had described a study’s results.

For his part, Dr. Cohen remains undeterred. Last month he published a new paper finding that experimental stimulants continue to be placed in sports and weight-loss supplements. That’s what research is supposed to do: give us more data, so that we can make better decisions about our health.

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