On the whole I think we credit this conflict-of-interest to the scientists, not the docs

Oct 06 2008 Published by under Scientific Misconduct

Nick Anthis of The Scientific Activist picked up an interesting story [LA Times, NY Times] involving financial conflict of interest, BigPharma, health care and Congressional inquiry. The story happened to circle around a chap who has M.D. after his name and is, apparently, a licensed and practicing(?) clinical psychiatrist. So the news reports and Anthis are to be excused for characterizing the gentleman in question as if he was exclusively or primarily a medical doctor.
Nevertheless Professor Charles B. Nemeroff, M.D., Ph.D., [CV here] regrettably, must be chalked up to the scientists as much, if not more, than to the physicians.


This latest kerfuffle about financial conflict of interest related to Nemeroff's consulting (and product promoting) for BigPharma is the third strike (at least) by my count. This one has drawn Congressional inquiry and really, go read the Grassley letter. The summary from the LA times story:

In the letter from Grassley to Emory, he said that Nemeroff consistently misrepresented the amount of money he received from Glaxo. In 2003, for example, Nemeroff said he received no more than $15,000 from the company, though the company says it paid him $119,756. In 2002, he reported receiving $15,000, but the company says it paid him $232,248.
Some of those payments were made within days of his signing a letter to Emory stating that he would limit his fees from Glaxo to $10,000 a year.
Crossing the $10,000 threshold would have required Emory to inform the National Institute of Mental Health and take steps to manage the conflict of interest -- including removing Nemeroff as principal investigator.

will give you a flavor of the accusation.
The prior episode (strike two) involved a review article co-authored by Nemeroff which promoted vagal nerve stimulation as therapy for (drug)treatment resistant depression. The event is overviewed on this blog post and a clinicalpsychiatrynews.com editorial from Nemeroff critics Carroll and Rubin. The short version was that the review was commissioned by a company (Cyberonics) which marketed a VNS device and for whom the (big name scientist) authors consulted. As you might imagine much discussion arose as to whether the review was authored by the big names or ghost written and endorsed-for-fee by the big names. Ultimately it appeared that the disclosure practices of the journal Neuropsychopharmacology had not been followed and the journal issued an erratum:

In the above article, it was disclosed that the report was supported by an unrestricted educational grant from Cyberonics Inc. Of the nine authors, eight are academic researchers who are also consultants for Cyberonics Inc. Although the authors submitted appropriate disclosures in accordance to journal policy, that information was not included in the acknowledgement section of the published paper. The journal staff is reviewing procedures to avoid ambiguity concerning author financial disclosures.

It did not help one little bit that Nemeroff was the Editor-in-Chief for the journal in question and the scandal eventually led to the toppling of Nemeroff from his position as Editor in Chief of Neuropsychoparmacology. Now from my perspective I was actually less distressed than most about the failure to include an acknowledgment in the paper itself. Mostly for the reason that one of the review authors listed a primary affiliation with the company in question. That right there is sufficient for me to taste my metaphorical pinch-of-salt when considering the review. I don't know that I would require any additional specific disclosure to think that the authors are consulting for the company in some way. Maybe I'm just cynical.
However I was already primed because of a preceding Nemeroff scandal (strike one) related to a review article he published, again promoting therapies for depression in which he had a significant financial interest. Nemeroff was called out by Carroll and Rubin in a letter to the editor.
The coverage in the NY Times hit the highlights:

The lead author of the article, Dr. Charles B. Nemeroff, chairman of the department of psychiatry and behavioral sciences at the Emory School of Medicine in Atlanta, said he would have reported the conflicts of interest, which include owning the patent on a treatment he mentioned, if the journal had asked him to.
-snip-
Dr. Nemeroff mentions roughly two dozen potential new therapies...One treatment he describes favorably is a patch that delivers lithium through the skin... He did not disclose that he held the patent on that patch.
-snip-
Dr. Nemeroff also did not disclose that he was a significant shareholder in Corcept Therapeutics, a company in Menlo Park, Calif., that is trying to develop mifepristone,... he wrote that there had been ''impressive studies'' with mifepristone, indicating that it ''is very effective in the treatment of psychotic depression.''... Dr. Nemeroff was given the option to buy 72,000 shares of its stock for less than $25 total. Those shares would have been worth more than $1 million if Corcepts had sold its shares to the public at a price of $14 to $16, as it announced it would do in late 2001. The company decided in the fall to delay that offering. Dr. Nemeroff said in an interview that he owned 60,000 shares of Corcept stock.
Dr. Nemeroff also did not disclose any of his ties to Cypress Bioscience of San Diego, whose sole product is milnacipran, a drug being developed to treat fibromyalgia, a chronic pain disorder. Dr. Nemeroff noted in his article that drugs that work in a similar way to milnacipran have been shown to be more effective than some other antidepressants.

What really irritated me about this prior case (beyond the obvious) is that Nemeroff's defense was basically that the journal didn't require disclosure (for review articles at that time). This was while he as Editor-in-Chief of a journal that did require such disclosure! (Although as we found out during strike two, above, disclosure to the Editorial offices on submission doesn't necessarily mean the policy was to actually put the disclosure on the actual article.) So it was really easy to suspect that perhaps he'd gone hunting journal policies until he found one where he could conveniently fail to mention his financial conflicts. Maybe not, but it sure did smell at the time.

So what?

I'm really exercised over this guy because he makes us look bad. First and foremost he made any scientist that has anything to do with helping private companies develop therapies look bad. High profile cases like these stick in the public mind and create a suspicion that we are all just faking up opinions (and perhaps even our data) to keep our paymasters in BigPharma happy. Second, he tars behavioral pharmacologists interested in the mental health conditions specifically because that is his domain and it brings attention, in these cases. to depression. It is further a problem that these scandals contribute to questioning the validity of therapy for such disorders. Leading to patients resisting what could be valuable drug therapy because they suspect it is all just a marketing scam and the drugs don't really work. In the broadest sense, this three-time loser makes all of biomedical science look bad.
First strike, Nemeroff did not so much as lose his Editor position. Second strike, he lost that but apparently retained his academic appointment, grants and lucrative BigPharma contacts.
I wonder what consequences he will suffer this time?

22 responses so far

  • I left the Emory Department of Psychiatry a few years before Dr. Nemeroff came [I left when his predecessor from Nemeroff's former University, Duke, came]. It was the dawn of the era of the psychoparmocologic takeover of Psychiatry. Even then, 25 years ago, it was all about "drug research." I remained on the Clinical faculty, so I've watched as the entire focus of the Department became "drug research" - most of which was doing drug trials. I don't think most of us knew that he was skimming personal money off the top, but we sure knew that this wasn't legitimate "research." It was more like product development and marketing.
    While it's comforting to see that someone finally called his hand and lowered the boom, it's a shame that it was allowed to go on for 20 years. Even without the financial hanky panky, these clinical trials and the endless speaking tours touting the products stunk to high heaven from 100 yards. Lets hope this crisis ends this sad period of corporate drug company buyouts of academic departments. Why was he tolerated? He brought the University tons of grant money...

  • pinus says:

    If it is any comfort to you...the disclosure policy for NPP has become much more strict since Nemeroff's departure.

  • juniorprof says:

    First and foremost he made any scientist that has anything to do with helping private companies develop therapies look bad. High profile cases like these stick in the public mind and create a suspicion that we are all just faking up opinions (and perhaps even our data) to keep our paymasters in BigPharma happy
    This is exactly right and none of us can really afford these types of problems right now. I really hope Emory (or congress) makes an example out of him.

  • Nick Anthis says:

    You make a valid point regarding whether Nemeroff should be called a scientist or a medical doctor. But, in the context of what I was writing about--doctors repping for drug companies--his medical credentials seemed most relevant. The Nemeroff case is particularly expansive, since some of the episodes you mention above involve something approaching basic scientific misconduct. So, in this case, Nemeroff being an academic scientist is certainly relevant and maybe more relevant to those episodes. However, my post was a commentary on the system of drug companies paying people to push their products in general. As far as I know, this practice is virtually exclusively limited to MDs (academic or not), and it is my impression that the vast majority of this practice (not just the instances where the rules were explicitely broken) involves people who are practicing medical doctors.

  • DrugMonkey says:

    I guess I got to ranting and failed to drive home the point that Nemeroff has published a very long list of papers. He does a great deal of clinical research. I expect that is is this research expertise that is his main draw for drug companies although, sure, it may be the case that he has an extensive clinical practice. given his wealth of academic type commitment listed on the linked (partial) CV this seems less likely.
    Don't get me wrong, I'm certain the fact that he's qualified as a clinician and probably sees some patients and can swing his MD credentials at audiences of physicians boosts his value. But I think it is his research that is the driver, hence my reluctant correction of the record on this.

  • cashmoney says:

    It's like Ted Stevens said:

    "It may be what we've done leaves the impression we've done something wrong, but you have to make up your mind you're doing something wrong, you have to have an intention to do something wrong to really be guilty of a crime..."

    So as long as you don't think whatever you are doing is wrong everything is wonderful.

  • Robert T. Rubin, MD, PhD says:

    As the Rubin in Carroll and Rubin noted above, let me say that "Strike 1" did not go unnoticed--Nature Publishing Group broadened its COI disclosure policy to include review articles and other submissions. Strike 2, as indicated, resulted in Nemeroff's resigning his editorship of Neuropsychopharmacology; per journal policy, it was his and his co-authors' responsibility to insure that the COI disclosures were included in the Acknowledgements section of the article. Regarding Strike 3, neither Dr. Carroll nor I had any hand in Sen. Grassley's decision to investigate, among others, Dr. Nemeroff. As the poster boy for COI, no matter whether he is considered a physician or a scientist or both, Nemeroff's utterances and writings are hardly credible.

  • DrugMonkey says:

    Dr. Rubin, thanks for stopping by and expanding on the outcomes. Hopefully I didn't imply that you and Dr. Carroll were involved in the Congressional inquiry, I didn't run across anything that suggested that and hadn't though this the case.
    As the poster boy for COI, no matter whether he is considered a physician or a scientist or both, Nemeroff's utterances and writings are hardly credible.
    While it is certainly important and critical that each bad actor be called out, repeatedly if necessary (and I thank you for your efforts), I do think there are larger implications here. In particular I was motivated to address what I see as the impression created that Nemeroff is just a practicing clinical MD. This is bad enough and certainly a matter of much discussion and progress in the past several years. It is important, however, for people to realize the ethical minefields exist for scientists as well. The negative consequences, in my view, extend widely across biomedical sciences when it comes to public trust.

  • Marilyn Mann says:

    "High profile cases like these stick in the public mind and create a suspicion that we are all just faking up opinions (and perhaps even our data) to keep our paymasters in BigPharma happy."
    In some cases, this actually turns out to be true. I am not so worried that the public will think *all* scientists can't be trusted. I am actually more worried that the public, due to DTC drug advertising, credulous media articles, and yes, in some cases, credulous doctors, will continue to buy exaggerated claims of efficacy and/or safety.
    "Second, he tars behavioral pharmacologists interested in the mental health conditions specifically because that is his domain and it brings attention, in these cases, to depression. It is further a problem that these scandals contribute to questioning the validity of therapy for such disorders. Leading to patients resisting what could be valuable drug therapy because they suspect it is all just a marketing scam and the drugs don't really work."
    IMHO, the unfortunate truth is that many of the drugs for mental conditions don't work very well. Some studies show an effect larger than placebo, but the effect size is usually small. There are many people with serious conditions such as major depression or schizophrenia who are not helped, or only marginally, by existing drug therapies. In some cases, these patients have tried every drug that is on the market.
    I agree that people like Nemeroff decrease the credibility of legitimate, ethical scientists. But the over-selling of psychiatric medications is also a problem.

  • Pharma targets MDs who do research, if you have an MD, PhD, so much the better. I used to give talks but got dropped because I wouldn't use only the slides in the 'approved' slide set. When my book came out a few months ago which, in my opinion, was a balanced review of the true risks and benefits of medications in all classes, Emory wrote a press release, but then never released it. Their explanation? The publisher was doing enough already. This is highly unusual behavior because other books coming out got press releases, web sites supported by them, etc, etc. I firmly got the impression that they didn't like my book because they thought it would upset pharma. However anyone who has read it says that it is 'fair and balanced'. So I said the heck with it and put the never released press release on my web site last week (my disclosures are also there). I am not making this point to push my book or to be sour grapes but to make the point that universities should promote the academic work of their faculty and protect them from, e.g., attacks from drug companies who don't like the outcomes of their research, act more like seats of higher learning and less like corporations, and stop worrying about their image and focus on doing the right thing. They would have been a lot better off now if they had done that before. Signed, a professor of psychiatry at Emory.

  • DrugMonkey says:

    juniorprof has a followup post which updates a bit on the continuing Grassley investigation.

  • DrugMonkey says:

    Janet Stemwedel has a post up on another of these COI clowns. Frederick K. Goodwin is being booted from a National Public Radio program gig for failing to disclose his ties to the pharma industry. As I mentioned at Janet's place, we are not discussing some mere radio yahoo here. Goodwin has serious credentials. Guys like Goodwin and Nemeroff should know better.

  • Guys like Goodwin and Nemeroff should know better.

    Where do you get the idea that they *don't* know better? Failing to disclose serves their financial ends, and so the simplest hypothesis is that they do know better, but choose not to disclose.

  • S. Rivlin says:

    I fully agree with CPP's sentiment. These a--holes know better, but just like any other crook, they always hope that no one will notice.

  • DrugMonkey says:

    It's a rhetorical device, dudes. They know better. Otoh, the mind is wonderful at rationalizing behavior- see political tricksters like Cunningham and Stevens and McCain ( just before getting busted for Keating). You can see this in the latest guy's excuse that he takes pay from competing companies so he's cool- sheesh. I think at some level they walk around feeling justified- but then don't many criminals feel the same?

  • S. Rivlin says:

    DM, you're correct about "...at some level they walk around feeling justified", they do it usually through self-persuasion that their actions are justified, not through objective consideration of the personal and social consequences of these action's unethical side. While we all have a little criminal in us, only the criminals allows him to take over.

  • DrugMonkey says:

    In the internal dialog it is easy to convince oneself that everyone is doing the exact same thing and thus it is all above board. Also, there is a whole cadre of psychiatrist / scientists who consult for BigPharma in all the same areas and hang out with each other professionally. I have little doubt that there is a little bit of mutual support going on here with everyone involved to some extent. The question is, how many are less-than 10K per year and reporting as they are supposed to do and how many are pulling down the eye-popping numbers reported for Nemeroff and now Goodwin?
    If everyone "knows" that someone else is more involved with industry then hey, they themselves must be ok, right?
    This is where public flogging comes in handy, especially if these situations have staying power in the news. Everybody gets reminded of what they are supposed to be doing and where those lines are.
    At the very least people should be made aware that their reporting requirements to their institutions should be taken seriously.

  • drdrA says:

    I'm dumbstruck. Did I just hear C PP and Sol agree about something? What's in your coffee today boys?

  • Nancy Bowling says:

    My younger sister who WAS a registered nurse had a vagal nerve stimulator implanted on Feb. 26, 2008 and within two weeks of the implantation was admitted to the hospital where she remains to this day. She had a seizure disorder that was not being managed with medication, so a vns was suggested. She has been in Rockland state for over a year now with a severe psychosis she developed AFTER THE IMPLANT. This is a girl who graduated from a christian college she attended on a basketball scholarship, then went on to become a registered nurse, meanwhile raising her daughter by herself and in the process of purchasing her first home. All that is gone. I have done extensive research on just how this device got approved in the first place and what I have found out is shocking. This whole approval was a sham. And Nemeroff is right dab smack in the middle of it. I am not stopping till I get to the bottom of this and make the people pay who destroyed my sisters' life and put my family through hell pay and are bought to justice. Of course Nemeroff is going to recommend the vns. He was chairman of Cyberonics Mechanism of Action Advisory Board. Nemeroff you NIMROD! You've already had to step down from being editor of the journal Neuropsychopharmacology. What a complete shame and a disgrace you are to the medical profession. I bet your parents are rolling in their graves.

  • I'm just a little curious. Exactly how many people have to die from a device before the FDA gets around to taking it off the market? On November 15, 2009 I got on the Maude Data Base and typed into the search bar: Cyberonics vns device causing death and the number was 1,850. I just did the same exact thing on June 30, 2010 and the number is now 3,290. There's another thing I don't understand. In their approval document P970003/ I have a question. If a company that manufactures a Class III medical device is given Conditions of Approval, and doesn't complete them, then does Reigel vs. Medtronics apply to them? In Cyberonics approval order P970003/S050 it states very clearly: FAILURE TO COMPLY WITH ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF PMA, and yet in November of 2008 Cyberonics submitted a proposal to the FDA to have those conditions changed, and they ACCEPTED! Wait a minute, those conditions should have been close to completion, not only that, but their approval order DOES SAY FAILURE TO COMPLETE ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF PMA. Am I the only one that's seeing somethings very wrong with this picture? I also found a court case against Cyberonics in which a woman named Diane Williams, who was the Plaintiff [Civil Action No. 06-5361] which said on page 10 that without proof that the VNS system did not adhere to the pre-market approval the Williams' claim must fail. [lexis.com] If anyone knows this woman, contact her and tell her to take them right back to court. Cyberonics' VNS system DID NOT ADHERE to the premarket approval. GO GET THEM GIRL!!!

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