Healthy Skepticism Library item: 17778

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
NIH Proposes New Rules For Researcher Conflicts
Pharmalot 2010 May 20
http://www.pharmalot.com/2010/05/nih-proposes-new-rules-for-researcher-conflicts/

Full text:

In a bid to restore public trust, the National Institues of Health has proposed new rules that would require academic researchers who receive agency funding to more thoroughly report any financial conflicts of interest, and also require institutions – such as universities – to do a better job of gathering this information and then forwarding it to the NIH. This includes posting info on a web site.
The move follows an ongoing probe by the US Senator Chuck Grassley of the Senate Finance Committee, who uncovered several examples in which academic researchers accepted funding from both the NIH and various drugmakers, but failed to fully or properly disclose the extent of their financial ties. At the same time, several universities failed to monitor their faculty for conflicts. At the heart of the issues is concern that healthcare providers are being unduly influenced by iindustry. The research generated by funding from the NIH and drugmakers often finds its way into medical practice by way of presentations and medical journal articles, especially those proferred by high-profile experts who often form relationships with one or more companies.
“The way in which science is moving forward, in order to be successful, partnerships between NIH funded researchers and industry are essential, they have been and will be, but we need to preserve the public trust,” NIH director Francis Collins told the media in a briefing this morning (listen here). “We believe, in the past, that the process followed has, for the most part, been succcessful. I don’t mean to imply I think there is a widespread problem, but there clearly have been a few examples in the last few years that …could be perceived as coloring their judgment in projects there were involved in.”
He didn’t mention names, but one example involved the former psychiatry chair at Emory University, Charles Nemeroff, who failed to report hundreds of thousands of dollars in payments from a drugmaker while researching the company’s drugs with an NIH grant (see here). There were several other high-profile episodes that you can read about here, here, here, here and here. Recently, Grassley also targeted the National Institutes of Mental Health specifically (see this).
As part of the proposal (here it is), a researcher whose holdings may be deemed a significant financial conflict of and exceed $5,000 should be reported to the university or institution that employs the researcher. According to current NIH regulations, the reporting threshold is $10,000. What’s significant? The aggregate value of, say, stock holdings, consulting or speaking fees, patent rights and royalties. The holdings must be reported on a web site run and updated regularly by the university or institution, and the amount of the researcher’s holding would be listed in dollar ranges: less than $20,000; less than $50,000; less than $100,000; lless than or equal to $250,000; greater than $250,000.
Institutions that fail to comply may see NIH grant funding suspended or terminated, although the actual enforcement mechanisms were not spelled out. In a statement sent us, Grassley called this “a step in the right direction.”