Can The NIH Really Monitor Conflicts Of Interest?
27 CommentsBy Ed Silverman // June 7th, 2010 // 8:21 am
For the past two years, the National Institutes of Health has been pressured by Congress to do a better job of monitoring conflicts of interest in which academic researchers accept funding from the agency and drugmakers. At issue is the concern that key research and subsequent studies will unduly influence treatment, and so the NIH recenty proposed tougher rules (see this).
Earlier this year, the US Senate Finance Committee extended its scrutiny to Tom Insel, the director of the National Institutes of Mental Health (see photo), given that many conflicts involved academic psychiatrists and drugmakers that market antidepressants and antipsychotics (see this). Now, The Chronicle of Higher Education peels back an interesting, long-running relationship between Insel and one of the more notorious subjects of the probe, Charles Nemeroff.
At the same time the NIH was grappling with the problem, Insel was “quietly helping” Nemeroff win a job at the University of Miami (see this), the paper writes. You may recall Nemeroff departed Emory University after the Senate probe disclosed he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug (background). The Department of Health and Human Services Office of Inspector General subsequently began an inquiry (see this).
Despite all this, the paper writes Insel also encouraged Nemeroff to apply for new NIH grants, “even though Emory had agreed on its own to restrict Dr. Nemeroff from NIH grant eligibility for two years. The NIH also allowed Nemeroff uninterrupted eligibility to serve on NIH advisory panels that help decide who receives NIH grant money.”
The paper cited e-mails (see the emails right here) between Insel and Pascal Goldschmidt, dean of the University of Miami’s medical school, who says Insel told him “Charlie was in absolutely fine standing.” He then tells the paper “Charlie committed to me that he would never make these mistakes again…As far as I can tell, Charlie does not engage in that type of behavior anymore, and I can tell you that if he was, I would know it.” And Goldschmidt adds he doesn’t feel obliged to accept Emory’s judgment about the two-year ban.
What this means for the NIH’s effort to toughen disclosure rules is unclear. The NIH’s regulatory review process, which was led by Insel and Sally Rockey, the NIH’s acting deputy director for extramural research, would allow universities to remain in charge of monitoring financial conflicts of interest involving researchers. As noted by Bernard Carroll, who chaired the psychiatry department at Duke University from 1983 to 1990, while Nemeroff was a professor there, the episode “leaves everybody scratching their heads as to what Insel’s posture and NIH’s posture about ethics is.”
An NIH spokesman tells the paper that Nemeroff is fully eligibile for agency activities and will begin serving this week on two scientific panels that review NIH grant applications. The NIH must “treat everyone equally unless they have been ‘debarred’ from funding,” the spokesman wrote the paper. Maybe so, but this also raises a question about the extent to which, if at all, the NIH is truly capable of monitoring conflicts of interest when one of its highest-ranking officials is involved in such a thorny relationship.
Hat tip to Health Care Renewal
tomd
How does Insel Co chair this panel when this is going on. I am not surprised but this is messed up.
emails show it all
Epic
totally ridiculous. nemeroff is radioactive.
Robert
The tone of this article is disgusting. It is written as if some secret Steig Larsson, Daniel Silva, Robert Ludlum conspiracy is in play here. That is not the case at all – here you have a couple of extraordinarily dedicated physicians who have in fact dedicated their lives to helping others – one of whom made some mistakes about reporting financial disclosures – i.e., not murder, not child abuse and not close to Goldman Sachs, – and the article blows it up as if there is some huge backlot plotting to commit a crime when all that is really goijng on is trying to help someone get back on his feet. The emails essentially say nothing of substance. We can ill afford to punish outstanding scientists indefinitely.
Stephany
This helps clear things up
http://hcrenewal.blogspot.com/2010/06/happy-times-at-nimh-part-iii.html
“In his recent published commentary, Insel downplayed the gravity of the ethical issues surrounding Dr. Nemeroff and some other academic psychiatrists. Basically, he allowed for them to cop a plea on the issue of disclosing payments from corporations, and he tried to point fingers at other medical specialties, while he glossed over the evidence of their wider corruption. With some sadness, one needs now to say that the Director of NIMH cannot or will not recognize the corruption of his cronies. Is that the style of ethical leadership we should expect from an NIH Institute Director?”–Bernard Carroll
Epic
Good point, Robert. All we have is a researcher like Nemeroff who used his government grants for years as marketing tools for big pharma. And included, is the Insel who looked the other way while he did it.
M. Black
No.
Robert
Epic and Stephany – you seem to have zero idea of what actually happened.
Dr. Smap
I agree with the first comment- how is Dr. Insel Co-Chair of the COI committee and this goes on-
i mean, i could see them speaking on the phone or private emails but to do this on official NIH email is odd to say the least.
Stephany
http://hcrenewal.blogspot.com/2009/10/nemeroff-seroquel-and-accme.html
“Dr. Nemeroff is so compromised by now that he has lost effectiveness as a front man for Pharma. Indeed, he is so toxic that he now glows in the dark.”-Bernard Carroll
Stephany
Or, maybe this one might help
http://hcrenewal.blogspot.com/2010/03/dr-pangloss-as-nih-institute-director.html#links
“Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about.” Bernard Carroll
Dr. ItsWhoYouKnow
This is academic medicine at its best – cronyism, mediocrity and money. This is analogous if not worse than priests abusing trusting children. Billions of dollars -federal money- being granted (handed) over to friends who then use that to claw their way up to more money (industry) and better positions eg Deans of Univ who then help your friends. Love it.
Larry Bone
It sends the wrong message. If a contractor accepts bribes to get a job “thrown over” to a particular company, he can lose his job and or be put in jail. Why are these guys so special that when they do that sort of thing, they get more work and more money? Only the little people go to jail. And another thing, you call this Science. Most docs and shrinks if they are feeling honest will tell you the prescribing of these drugs is all trial and error. In other words these professionals are a little ignorant as to how these drugs work scientifically and to that extent, don’t know what they are doing. But hey, they’re professionals. It’s okay to screw up! They screw up with one drug and add 2, 3 or 4 more to try to correct the damage and end up making it all worse. Who gave them the right to play with the lives of innocent little babies, kids, teenagers, adults, soldiers, and the elderly? Shame on Them!!!
LilyK
To Robert In Medicine MISTAKES costs lives. Who said it was a mistake?.When will America have Ethical Health Care? When all elected and Officals stop taking money from Health care Industry, Medical profession and Pharmaceuticals—it is all about money. Every Government Agencey is unethical and does not protect the people—They are only interested in—MONEY—GRASSLEY AND HIS FINACE COMMITTEE MEMBERS ARE CORRUPT TOO—THEY ARE UNABLE TO STOP THE CONFLICT OF INTEREST IN THE HEALTH CARE INDUSTRY—WHICH IS CRIME. WHEN WILL AMERICA RULE WITH HONESTY AND THE TRUTH??????????????
Evelyn Pringle
Aside from everything else, I’m sick of my tax dollars going to fund grants for these legal drug pushers, just because they have the title of a major university behind their names. If they want to live so high off the hog, let them go be full-time drug pushers on a Pharma payroll.
Ed Goodwin
The NIH is is a feeding ground for university professors advancing their own “publish or perish” and extra income motivations. A competitor of my company helped secure $8.5 million of NIH funds to advance his product
over others on the market. The funded research was loaded with conflict of interest, lack of
safety disclosure and fraud. The case is going to trial in Boston soon.
The NIH mission is to improve the public health, but please do not destroy the free enterprise system in the process!
Stephany
That wouldn’t be Biederman and Risperdal protocol breach lawsuit would ,Ed Goodwin?
Ed Goodwin
Stephany, No. It is Hipsaver V Kiel. And there
is a protocol breach to boot!
Stephany
Interesting, I’ve heard of that via Scientific Misconduct blog-Dr.Aubrey Blumsohn
http://scientific-misconduct.blogspot.com/2008/03/threats-and-hipsavers-in-osteoporosis.html
Ed Goodwin
Blumsohn did not have the advantage of court ordered discovery of e-mails and documents that are behind the study. And is wrongly transfering his “authority” from the medical field to the legal field. In short, he shot his mouth off with no basis.
Stephany
Do you know Dr. Blumsohn? he’s well respected for standing up for truth and ethics in scientific research.
What company are you from again, Ed Goodwin?
Ed Goodwin
HipSaver,Inc.
In searching for an ethics expert for this case, I have found that there is a good supply of people like him that like to write and give presentations about medical ethics, but when the rubber hits the road they lack the courage to take the “stand”. ie ethics does not equal courage and courage is the one virtue that guarantees all others.
What is your affiliation Stephany?
Stephany
Dr. Aubrey Blumsohn is actually a whistleblower, hardly one to be labeled as not having courage to stand.
I have no affiliation with any drug company, I am familiar with Aubrey’s story via blogging etc.
Why am I in this conversation? because I do believe in truth, ethics etc in Pharma, as a parent of a child injured by psychiatric medications currently disabled and trying to re-learn things, such as self care, and talking.
Ed Goodwin
Sorry to hear about your situation. There is too much of this going on.
Stephany
Absolutely, Ed Goodwin, and thanks.
John M. Nardo MD
In Atlanta, we were relieved to see Nemeroff sanctioned and defrocked, but I fear that Emory’s investigation fell far short of what was needed. Emory essentially rubber-stamped Nemeroff’s “I didn’t know the rules” in spite of firmly reminding him of the rules in 2004.
The University of Miami must not have Internet services because it doesn’t take long to ferret out the Nemeroff story. Rather than a jillion blog posts, someone needs figure out a way to block Nemeroff’s further participation in NIMH Grants of any kind – period.
Stephany
Maybe he can find a job rolling Cigars in Cuba.
Scott
What emails don’t disclose is everything. The tone of voice, intent of
the words used or how they where used. Also missing is something
previously said not in the email and how the email words relate to that.
TO me the bigger issue with NIH emails is the fact that they are screened
as if NIH employees are NSA members or National Security members
involved in high level intelligence regarding our national security.
The rules put to researchers are greater than congress itself and I mean
both houses. For that matter even White House staffers who in the Bush
administration broke national security rules by using their clearance to
share classified info with civilians. Then when NSA calls them on it NSA
members at the highest level are threatened with treason.
Now, remove the lobbyists from writing laws with congressional staffers,
congress persons from flying corporate jets, corporate outings etc. IF
you want to be concerned about something you should be worried
what congress says in their emails. Not one of them would stand up
the scrutiny scientists at NIH doing research to provide cures for disease
are ask too. The result is that top scientists researchers stay away from
serving NIH and their country. Good job Congress, not.