NIH Proposes New Rules For Researcher Conflicts
5 CommentsBy Ed Silverman // May 20th, 2010 // 12:05 pm
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.”
Michael Kirsch, M.D.
Some folks want to sever all ties between medicine and industry. This is overly restrictive and would not serve the greater good. While there have been excesses, and conflicts need to be examined, industry and medicine can have a symbiotic relationship. If we eliminate all of the real and perceived conflicts, then we may be left with physicians and scientists who do not have the requisite experience and expertise to teach and write. While addressing conflicts is a real issue, let’s not make the cure worse than the disease. http://www.MDWhistleblower.blogspot.com
MsPiggy
That comment was just precious, “some folks” like those patients and people with a actual conscious? or are you referring to those rare astonishing professionals that might happen to actually believe that solemn oath they took really means something. You do remember those simple words “do no harm” correct.
You talk about conflicts and excesses like they were incredibly rare occurrences (for which they are not in reality).
MDWhistleblower, I do have to question this “name that tired old apologist tune” you appear to be playing here on that well polished MD flute.
Speaking personally for the greater public good. I’m willing to take that great risk and leap of faith on those non conflicted and ethical inexperienced physicians and scientists over your industry sponsored, conflicted, and controlled key opinion leaders pimps.
Rampant greed, criminal practices, and unethical professional conduct is not a medical disease MD’s are equipped or have the expertize to effectively treat to be blatantly honest with you Kirsch M.D..
But you can just keep on barking up your symbiotic relationship fantasy tree , and the growing public up-swelling of disdain will continue to demand accountability from both the doctors and pharmaceutical industry that have over and over again violated a sacred trust with continued disturbingly horrific health and financial consequences for everyone.
You may just be unpleasantly surprised how powerful focused righteous anger can be one day in the not to distant future.
Stephany
Re:Michael Kirsch,M.D.:
http://alison-bass.blogspot.com/2009/12/christmas-comes-early-for-3700-us.html
Christmas comes early for 3,700 US doctors on GlaxoSmithKline’s payroll-Alison Bass
“GlaxoSmithKline became the third pharmaceutical giant to start disclosing all the speaking and consulting payments it makes to US doctors, and its list is an eye-popping illustration of the rampant corruption that runs through our current system of medical research.”
http://alison-bass.blogspot.com/2009/12/christmas-comes-early-for-3700-us.html
SteveM
The sad fact is that these new reporting rules are almost meaningless.
Doctors don’t care what other doctors make. Outed CME pimps aren’t shunned by their peers.
The institutions don’t care. A Pharma pimp like Charles Nemeroff leaves Emory and is welcomed with a big fat compensation package at the University of Miami. Nemeroff’s oily behavior hasn’t hindered him one bit.
And the average patient scrolling through data bases to check out a physician’s Pharma entanglements? Ain’t gonna happen.
The data bases will serve no real purpose. This is a no-solution solution.
harpy
I don’t know, SteveM. I think the government, and especially all of those keen AGs out there, is going to have a field day with the numbers.