accentuate the positive, eliminate the negative

Posted on Sunday 13 June 2010

"As for Dr. Nemeroff, he is yesterday’s news. The adverse findings by ACCME about his program serve as a reminder to corporate sponsors and CME companies that 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 MD: Healthcare Renewal

Dr. Bernard Carroll is the former Chairman of the Department of Psychiatry at Duke Medical School. He was a pioneer in biological research himself, and now write on the above mentioned blog, usually about medical ethics. When the first scandal involving Dr. Nemeroff emerged, I wrote Dr. Carroll because since Nemeroff came to Emory from Duke, I thought Dr Carroll had trained him. He wrote back that Nemeroff had trained elsewhere, but had then come to Duke on the faculty. Dr. Carroll added: "After Dr. Nemeroff joined us at Duke I did my best to act as a role model to him concerning academic and personal values, and to monitor the ethics of his behavior. That was an exasperating experience for me. I often found my self using the term incorrigible." I quote Dr. Carroll here comfortable that he would say this in person to anyone who asked.

Charles NemeroffI thought my last post [the trivialization of america…] would be enough to get Dr. Nemeroff out of my mind, but I was obviously wrong about that. It just brings back too much. I recall something that I found myself having to deal with a long time ago, back in the days when I was in the business of training Psychiatrist at Emory – long before Nemeroff ever came on the scene. Some of the finest physicans I’ve ever met have been Psychiatrists, but also, so were some of the worst. Psychiatry is on the edge of medicine, and the old joke that Psychiatrists are a bunch of nut cases isn’t true, but sometimes it’s not false either. There were plenty of people applying for training who were on the fringe, and occasionally one of them would slip through the net. By the time such a person was in training, they had already finished medical school and become licensed. I didn’t have trouble firing residents who were ethically challenged or who didn’t have the will or capacity to do the job. But then came the question of what to say, when requests for letters of recommendation showed up as they always did. Does one soft-pedal the truth or tell the story and hurt the former resident? It’s an easy question to answer in the abstract, but in practice, it’s pretty hard. Who wants to scar someone for life? Who wants to let someone pass who might be dangerous? I ended us writing the "nicest" "truthful" letters I could write. But if I thought the person was dangerous or a sociopath, I made that very clear. There were a few that threatened to sue me, but nothing came of those threats.

So back to Dr. Nemeroff. Dr. Nemeroff’s ethics have been in question from the start. As Dr. Carroll said above, he was "incorrigible" in his first faculty position at Duke. He was certainly that way at Emory. He’s very smart and he brought in millions of research dollars from Drug Companies and Government Grants, but he was known to be an Industry Whore by anyone who gave it any thought. After misbehaving at Emory, being defrocked, and barred from research – he moved on to the University of Miami to have another shot at things. Will he do the same thing there that he did at Emory? Guaranteed! Emory apparently was unwilling to tell Miami the truth about Dr. Nemeroff, agreeing with his excuse that he just didn’t know the rules. The University of Miami was so seduced by Nemeroff’s track record of bringing in Grant money that they overlooked his obvious sociopathy, clear to anyone with an Internet connection. Shame on Emory and the University of Miami…

My guess is that Emory struggled with the same issue I used to worry about with those fired residents and their letters of recommendation. I was dealing with people who didn’t have any power, but Charlie Nemeroff has wielded a lot of power in the past, and I suppose that Emory was afraid to simply say to Miami, "Charlie Nemeroff is a bad apple, incorrigible, so toxic that he now glows in the dark, a criminal." The fact that he’s smart and powerful is all the more reason to tell the truth about him. This is a man who allowed Drug Companies to ghost-write his articles, accentuat[ing] the positive, eliminat[ing] the negative.  This is a man who recommended a drug be used in pregnant women that causes serious birth defects – because that’s what the Drug Company paid him to do. This is a man who moved from a mansion in Atlanta to Miami [buying a $1.2M house with six bedrooms and seven baths in the posh Coconut Grove neighborhood] to start his scam all over again. Instead of being passed on by Emory to become Chairman of Psychiatry at the University of Miami, he should probably be disbarred from medicine altogether – maybe even fitted with an orange jumpsuit in one of our local prison facilities.

Thoughts on Charles Nemeroff’s Not So Excellent Adventure
Healthcare Renewal
by Roy M. Poses

10/07/2008
More than one bad apple
Nature [Editorial]

10/16/2008
Nemeroff Accepts Offer at U. Miami
emorywheel.com

By Kate Borger
11/20/2009
As He Worked to Strengthen Ethics Rules, NIMH Director Aided a Leading Transgressor
Chronicle of Higher Education

By Paul Basken
06/06/2010

A yearlong effort by the National Institutes of Health to toughen its policies against financial conflicts of interest was led by an administrator who quietly helped one of the most prominent transgressors get hired by the University of Miami after a decade of undisclosed corporate payments led to his departure from Emory University, a Chronicle investigation has found. The administrator, Thomas R. Insel, director of the National Institute of Mental Health, also encouraged the researcher, Charles B. 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 Dr. Nemeroff uninterrupted eligibility to serve on NIH advisory panels that help decide who receives NIH grant money.

Dr. Insel "confirmed to me that Charlie was absolutely in fine standing" with the NIH, Pascal J. Goldschmidt, dean of the University of Miami’s medical school, said of a July 2009 phone call he made to Dr. Insel just before hiring Dr. Nemeroff. The actions by Dr. Insel, during a period of heavy Congressional pressure on the NIH to institute reforms, raise new questions about the NIH’s stated commitment to attacking the problem of financial conflicts of interest in taxpayer-financed medical research.

"It leaves everybody scratching their heads as to what Insel’s posture and NIH’s posture about ethics is," said Bernard J. Carroll, who served as chairman of the psychiatry department at Duke University from 1983 to 1990, while Dr. Nemeroff was a professor there. Dr. Insel has declined months of requests from The Chronicle for an interview to discuss the matter, including his relationship with Dr. Nemeroff. The NIH’s director, Francis S. Collins, was not available for comment, his spokesman said late last week. Dr. Nemeroff also declined to be interviewed, a University of Miami spokeswoman said…
 
At the NIH, conflicting stories of conflict of interest
Washington Post

by Al Kamen
06/09/2010

It’s been just three weeks since the National Institutes of Health announced new guidelines to deal with long-standing concerns that federally funded researchers were being influenced by millions of dollars from the drug industry and other companies, which would naturally love to see the researchers’ efforts reach the right conclusions. The NIH’s tougher disclosure requirements came in response to a spate of bad press showing huge private-sector bucks flowing to researchers at universities and institutes and the like, creating, as NIH Director Francis S. Collins said, an appearance of a conflict of interest that could undermine public trust. "We cannot afford to take any chances with the integrity of the research process," Collins said.

Then came a June 6 Chronicle of Higher Education article alleging that Thomas R. Insel, director of the National Institute of Mental Health and a leader in the effort to strengthen ethics rules, had helped Charles B. Nemeroff, a researcher who left Emory University last year after Senate investigators concluded that he had failed to disclose at least $1.2 million of some $2.8 million he had received over seven years from pharmaceutical companies. Emory said it would not allow Nemeroff to apply for NIH grants for two years. But that restriction did not carry over to a future employer, such as the University of Miami — where Nemeroff got a job, the Chronicle said, with a helpful recommendation from Insel. Nemeroff, in an e-mail obtained by the Chronicle, thanked Insel, saying "I appreciate your efforts."

The Chronicle article prompted Sen. Charles E. Grassley (R-Iowa), who has been all over the battle to clean up federally funded research, to ask Health and Human Services inspector general Daniel R. Levinson, who has had Nemeroff "under investigation" by his office, to look into the matter. Insel, however, called the article a "little surreal." He didn’t have "any great relationship" with Nemeroff, he said in a telephone interview, and what Nemeroff "had done was so outrageous, he became the poster boy for conflict of interest." "I didn’t recommend him" for the Florida job, Insel said, but only clarified to an official there that Nemeroff was not barred from applying for future NIH grants.

The problem, he said, was that after Nemeroff was "penalized" at one institution, he "jumps to another. I can see why Sen. Grassley is upset," he added. "I would be upset at that, [but] we can do nothing about the individual – the grants are given to the institution." Sounds like the new guidelines may be in for some revisions once Grassley’s through…

Sen. Charles Grassley has written a strongly worded letter to University of Miami President Donna Shalala saying he is "disturbed" and "troubled" by actions surrounding UM’s hiring of a psychiatrist-researcher under investigation by a federal agency. The letter from the Iowa Republican, dated Monday, was sparked by a Sunday story in The Chronicle of Higher Education about the relationship between psychiatrist Charles Nemeroff, now head of UM’s department of psychiatry, and Thomas R. Insel, director of the National Institute of Mental Health, who led a yearlong project to toughen policies against conflict of interest.

On Wednesday, UM issued a brief statement: "The University of Miami is responding to the inquiry from Senator Grassley and will continue demonstrating its unflinching commitment to scientific integrity. UM works tirelessly to advance the quality of its teaching, research, and clinical care programs while maintaining the highest ethical standards in all that we do.” The National Institute of Health said Insel was unavailable for comment.

Grassley and his staff have been investigating Nemeroff, once head of psychiatry at Emory University in Atlanta, because he received millions of dollars from drug companies while doing what was supposed to be impartial research for the National Institutes of Health on drugs made by the companies paying him. Grassley reported Nemeroff received $2.8 million from GlaxoSmithKline and other drug makers over seven years for promoting drugs like GSK’s Paxil. Emory eventually asked him to step down as head of psychiatry and suspended his work on major NIH grants…
Donna E. Shalala
President
University of Miami
Coral Gables, FL 33124

Dear Dr. Shalala:

As a senior member of the United States Senate and the Ranking Member of the Committee on Finance (Committee), I have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the activities of the National Institutes of Health (NIH/Agency). In this capacity, I must ensure that NIH properly fulfills its mission to advance the public’s welfare and makes responsible use of the public funding provided for medical studies. This research often forms the basis for action taken by the Medicare and Medicaid programs.

For the last several years I have worked to achieve public disclosure of financial relationships between physicians and the drug, device and biologic industries. Beginning in the summer of 2008, I began demonstrating that universities are not properly managing their professors’ financial conflicts of interest and that change is needed at the NIH.

I was disturbed to read a story today in The Chronicle of Higher Education.1 For over a year, Dr. Charles Nemeroff has been under investigation by the Health and Human Services Office of the Inspector General for failing to disclose his conflicts of interest regarding the grants he received from the National Institute of Mental Health (NIMH). During this same time, The Chronicle of Higher Education reports that the Director of the NIMH was assisting Dr. Nemeroff in obtaining a new job and made assurances that Dr. Nemeroff would be able to apply for new NIMH grants.

I was also troubled by Dr. Goldschmidt’s comments that a ban against Dr. Nemeroff from receiving NIH grants was “an immediate reaction to the political pressure that the university was under.” President Shalala, I hope that you would agree–contrary to Dr. Goldschmidt’s views that disciplining researchers for failing to disclose conflicts of interest is merely a political issue–that enforcing federal conflict of interest policy involves ethical and legal issues that ensure taxpayer trust.

Accordingly, I ask that you respond to the following requests for documents and information. Please respond by first reiterating the question, followed by the appropriate answer.
[1] Please provide all conflict of interest forms filed with your university by Dr. Charles Nemeroff.
[2] Please provide all emails and communications by Dr. Goldschmidt regarding Dr. Nemeroff’s conflicts of interest.
[3] Please provide all emails and communications by Dr. Goldschmidt regarding Dr. Nemeroff’s work and/or grants with the NIH.
[4] Please provide all emails and communications by Dr. Nemeroff regarding conflicts of interest.
[5] Please provide all emails and communications by Dr. Nemeroff .

In cooperating with the Committee’s review, no documents, records, data or information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committee.

Please respond by no later than June 21, 2010. Thank you for your attention to this important matter. Should you have any questions regarding this letter, please contact Paul Thacker of my Committee Staff at (202) 224-4515. All formal correspondence should be sent electronically in PDF format to Brian_Downey@finance-rep.senate.gov or via facsimile to (202) 228-2131.

Sincerely,
Charles E. Grassley
Ranking Member [Senate Finance Committee]

Update: From a a previous post about Nemeroff’s protege, Dr. Zach Stowe.
As a former full time member of the Emory Departrment of Psychiatry, this report is pretty painful for me to read. It’s actually worse than this article explains. Senator Grassley’s letter has some attachments, emails between Dr. Stowe and GlaxoSmithKline. There’s a contentious exchange when GSK cancelled a couple of Dr. Stowe’s scheduled promo talks for lack of attendees. He demands payment because they interfered with his schedule [he could’ve scheduled some other lucrative talks]. But the worst part is in this email:
 
In the second part, he’s demanding his money for the canceled appearances. But what the first part says has to do with studies he was doing about using antidepressants in pregnancy. He’d already published a study saying that Paxil was safe for nursing mothers [wasn’t found in breast milk]. Apparently, in this study, he was trying to see if he could say it was safe for pregnant women [ergo, didn’t make it into the amniotic fluid]. He says, "DAMN IT" meaning he wasn’t able to give them what they wanted. Apparently he’d already planned to write "paroxetine [Paxil] undetectable in amniotic fluid."  That’s hardly the way a researcher talks. It’s the way a "co-conspirator" or an "employee" talks. Notice he says, "I’ll have the manuscript for you to review right after I finish the Grant stuff."  This study was funded by a grant from the National Institute of Health, not GSK! Yet the drug company is going to review the manuscript? If that’s actually the case, this is a pitiful excuse for academic medicine.
  1.  
    June 13, 2010 | 9:53 PM
     

    Schadenfreude is getting pretty thick here.

    Charlie flashed his true colors even before he was on the job at Emory years ago. Remember how that first time he came to visit, after he got the job at Emory, before he moved here? He had a chaffeured Rolls Royce driving him around and waiting while he was in meetings. it didn’t go over well with the troops.

  2.  
    June 13, 2010 | 10:02 PM
     

    Schadenfreude (pronounced /ˈʃɑːdənfrɔɪdə/ German pronunciation: [ˈʃaːdənˌfʁɔʏdə]) is pleasure derived from the misfortunes of others.

    Guilty of Schadenfreude as charged! I also feel relieved at there being some potential public closure to this sorry state of affairs. And as to Senator Chuck Grassley, even Religious Right Conservatives who are in The Family can sometimes do the right thing…

  3.  
    June 14, 2010 | 5:17 PM
     

    I wasn’t trying to make you feel guilty for Schadenfreude. I was saying I feel it myself and there’s so much shit, it’s getting thick.

    And: it seems I was so eager to post that comment that I didn’t finish readubg your post with Zack’s email. That is really abominable. How reliable can results be when the researcher wants so much for it to come out one way? He’s already chosen his title for the article, and DAMN IT, the numbers won’t cooperate !!!

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