Thursday, December 17, 2015

UCSD fails to comply with research reporting law 98% of the time

Law ignored, patients at risk
Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found.

The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer.

The worst offenders included four of the top 10 recipients of federal medical research funding from the National Institutes of Health: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. All disclosed research results late or not at all at least 95 percent of the time since reporting became mandatory in 2008.

Drug companies have long been castigated by lawmakers and advocacy groups for a lack of openness on research, and the investigation shows just how far individual firms have gone to skirt the disclosure law. But while the industry generally performed poorly, major medical schools, teaching hospitals, and nonprofit groups did worse overall — many of them far worse.

The federal government has the power to impose fines on institutions that fail to disclose trial results, or suspend their research funding. It could have collected a whopping $25 billion from drug companies alone in the past seven years. But it has not levied a single fine.

The STAT investigation is the first detailed review of how well individual research institutions have complied with the law.

Read more: Popular heart surgery carried hidden danger

The legislation was intended to ensure that findings from human testing of drugs and medical devices were quickly made public through the NIH website Its passage was driven by concerns that the pharma industry was hiding negative results to make treatments look better — claims that had been dramatically raised in a major lawsuit alleging that the manufacturer of the antidepressant Paxil concealed data that the drug caused suicidal thoughts among teens.
“GlaxoSmithKline was misstating the downside risks. We then asked the question, how can they get away with this?” Eliot Spitzer, who filed the 2004 suit when he was New York attorney general, said in an interview.

The STAT analysis shows that “someone at NIH is not picking up the phone to enforce the obligation to report,” Spitzer said. “Where NIH has the leverage through its funding to require disclosure, it’s a pretty easy pressure point.”...

No comments: