False claims epidemic in biomedical research?

by Kurt Schulzke

If you thought politicians were a breed apart, think again.  A recent article published in Scientific American suggests pols and scientists have something in common: an affinity for stretching the truth.  An Epidemic of False Claims, points to the likelihood of a growing universe of potential False Claims Act whistleblower cases in the biomedical-research arena:

False positives and exaggerated results in peer-reviewed scientific studies have reached epidemic proportions in recent years. The problem is rampant in economics, the social sciences and even the natural sciences, but it is particularly egregious in biomedicine. Many studies that claim some drug or treatment is beneficial have turned out not to be true…

Where such false positives and “exaggerated results” occur in the context of government-funded research and result from either intentional or reckless misrepresentations by scholars or other scientific investigators, a whistleblower claim may be found. False claims may also result from misrepresentations (say for example about compliance with conflict of interest management or disclosure requirements) made by institutions or scientific investigators in applying for government grants to fund research.

A July 2010 False Claims Act award against Cornell University’s Weill Medical Center (“WCMC”) offers one example.  The jury in the WCMC case found that a Cornell researcher had repeatedly misreported procedures implemented under an NIH grant and that this false reporting induced the NIH to continue funding the researcher’s HIV/AIDS project.  The court ordered WCMC to pay $887,714 in damages to the government and an additional $631,882 in attorneys’ fees, costs and expenses to the whistleblower, Dr. Daniel Feldman.

The case is U.S. ex rel. Feldman v. van Gorp, No. 03 Civ. 8135(WHP) (SDNY).  The district court’s denial of Cornell’s motion for summary judgment is reported at 674 F. Supp. 2d 475 (SDNY Dec. 2009).  Cornell’s appeal is now pending before the 2nd Circuit.

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