Field of Science

Emory in a little, Nemeroff in big, trouble

One of the perks of becoming an academic professor is the side income which you can generate by consulting for companies, especially pharmaceutical companies. While that is a healthy way of supplementing your income and in fact provides some incentive for people to go into academia, it would be imperative to disclose any conflict of interest you may have, and in fact most authors do so in journal articles for example. This would be absolutely key if you were using a company's products in your supposedly fair, unbiased and balanced academic research.

Apparently Charles Nemeroff, Chair of the Psychiatry Department at Emory University, does not think so. I was a little shocked at the news partly because these days I am reading the classic psychopharmacology textbook that he co-authored with Alan Schatzberg and finding it quite eye-opening. But nothing in the book opened my eyes wider than this piece of news from the NYT:
One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators.

The psychiatrist, Dr. Charles B. Nemeroff of Emory University, is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.

In one telling example, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from that company — 17 times the figure he had agreed on.
And why was disclosing this windfall deathly important for Dr. Nemeroff? Well, because:
Dr. Nemeroff was the principal investigator for a five-year $3.9 million grant financed by the National Institute of Mental Health for which GlaxoSmithKline provided drugs.
So Nemeroff was on an NIH grant that involved using GSK drugs, and was getting paid princely sums by GSK at the same time. It's hard to have a better definition of conflict of interest. And even in an age when the sum of 700 billion$ is being bandied around rather casually, 2.8 million$ is still a lot of money.

It also does not seem to be the first time that he has blurred the line. In 2006 he seems to have stepped down from the editor's position of the journal Neuropsychopharmacology when he published an article using a device whose manufacturer was paying him. As detailed above, he also had had an incident with Emory in 2004 when he promised not to make too much money off his consulting. Dr. Nemeroff regularly gives talks in which he discusses the benefits of drugs like Paxil.

It's also interesting that some people suspect that Nemeroff may have had a hand in David Healy being denied his position at the University of Toronto. Healy has written a very interesting book called "Let them eat Prozac" which rather meticulously and candidly documents the alarming incidence of suicide attempts by patients on SSRIs. Apparently Healy faced a lot of hostility from the establishment and...surprise...from pharma when he tried to go public with these findings. It's all disturbing.

I really hope Emory takes some drastic action against what seems to be a repeated violation of some extremely important and time-honored guidelines of research. It's getting uncomfortable, and fingers are being pointed at the school for not noticing this and taking action earlier. The sooner the university acts, the better it can save face and avoid embarrassment.

But the gnawing questions remain. Since the line between a productive and honest and unholy academic-corporate nexus seems to be thin indeed, who regulates such collaborations and how can they do this? Sadly we know all too well who pays.

Other links: The Carlat Psychiatry Blog, University Diaries, Pharmalot

6 comments:

  1. Ashutosh:

    Be very careful about swallowing Healy's work about suicide and SSRIs. As the tragic death of David Foster Wallace has made abundantly clear, depression is a disease with a mortality as well as a morbidity.

    The studies which led to the warning about suicidal ideation in adolescents on the SSRIs did document the ideation, but among the study group there were NO actual suicides. The FDA put a warning label -- what has been the result? Unfortunately, the data are coming in glacially slowly -- but there has been a roughly 20% increase in the rate of adolescent suicides and a 20% drop in SSRI use in this age group since the warning.

    Along these lines, the FDA's decision to release a list of drugs they are studying for possible post-release side effects is likely to result in further disasters of this sort.

    I've asked Derek Lowe to write about the SSRI story on his blog "In the Pipeline" and he said he woluld, but upheavals in the pharmaceutical industry have kept him from it.

    Also, it's sad to see such sleazy behavior by a fellow doc. It invariably reflects on the entire profession, just as research fraud does on yours.

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  2. Thanks for pointing that out; while Healy's book is quite detailed, the verdict on SSRIs and suicidal ideation clearly seems to be still out there. I guess the old question of correlation vs causation still plagues all of us as much as ever.

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  3. The FDA warning constitutes the largest (uncontrolled) experiment we'll ever have on SSRIs and adolescent suicide rates. It yields only correlation because all we have is historical (not concurrent) controls -- but the historical controls are recent -- e.g. the years immediately before the warning. However, 300,000,000 in the pool is a significant number (you must count parents as well as teenagers among this number) and a 20% increase in the adolescent suicide rate two years running (as I recall) is unlikely to be a statistical fluke. You NEVER get better epidemiological evidence than this.

    This is exactly why the clarity of chemistry and molecular biology is so appealing. It certainly isn't as directly important as the (possibly unncessary) death of an adolescent, but it is so much cleaner intellectually.

    Fortunately, the warning came out after I retired, but I've been in a similar position with other medical issues (notably TPA for stroke).

    Next, put yourself in the position of an MD faced with a depressed adolescent who doesn't believe the warning of the FDA (like me). He/she knows that SSRIs don't always work (what therapy does?). To do the best by the patient according to his/her thinking an SSRI would be prescribed. If it doesn't work and a suicide on medication occurs (as invariably it will), he/she is likely to be successfully sued. What would you do in this situation -- protect yourself and your family or the patient? That is likely why the prescription rate dropped since the warning, and why the suicide rate went up.

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  4. 20% is a obviously a huge number. One thing which I think we can all agree with is that antidepressants are prescribed like crazy in this country. If you have a problem, there's a pill for it.
    As for the case of the not-at-all-hypothetical MD, all we can do is make sure that knowledge is dispensed to patients in a timely and accurate manner. It is important to have all the knowledge, but there clearly is a conflict between doctors when the FDA issues such guidelines. I think this scenario speaks volumes about the sad, overmedicated and overlegislated state of the Union where everyone is paranoid and wants to make 100% sure that they won't get sued, a state of certainty that does not exist. Unfortunately many patients don't really understand and it serves to confuse them instead of enlightening them. I don't know what's the way out of this dilemma.

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  5. " everyone is paranoid and wants to make 100% sure that they won't get sued". The suit rate for an MD in practice over 20 years is over 50% (or at least it was when I left practice in '00). You do what you can to avoid being sued, malpractice suits not rare events.

    An analogy closer to home for your readership would be an accusation of research fraud.

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  6. Ashutosh,

    Nice post. Being in academia, I understand what you mean. However, there are a few differences in how b-schools operate with respect to external grants, consulting gigs and their influence on reputation. I am not sure if it is market dynamics, but the salaries paid to b-school faculty allow them to pursue research that is not directly tied to the financial interests of firms directly.

    I guess the implications of the scope of results and effects between management research and medical fields facilitates the differences in the two fields.

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