Wednesday, June 9, 2010

Uh Oh! Thomas Insel gets pulled into Nemeroff's World

One truism of professional life is that some favors, no matter how alluring, should be politely turned down. The trick is predicting which bestowers of favors spell D-A-N-G-E-R, and which do not. Unfortunately, it looks like Dr. Tom Insel, the director of the National Institute of Mental Health, made the mistake of accepting multiple favors from Charles Nemeroff, and he is now paying the price.

Several media outlets have covered this developing saga, or scandal, or Greek tragedy (following the analogy of the Trojan horse, the most famous examples of bad judgment in gift-accepting). The best and most thorough coverage is in this article in The Chronicle of Higher Education, which broke the story. Also, see today's coverage in the Washington Post, and ongoing coverage in Health Care Renewal.

Here's the digest of key events. Charles Nemeroff is a psychiatrist and researcher who makes friends easily, gives great talks, and exudes charisma and power. He's probably a genius and has an encyclopedic knowledge of neuroscience. Unfortunately, he has shown repeatedly that he is willing to bend institutional rules and play loose with the truth in order to accomplish his various financial and professional objectives. His self-imposed trials and tribulations are well known to readers of this blog.

The Low Points:

--2002: Nemeroff co-authored a review article saying wonderful things about an investigational antidepressant, mifepristone, without disclosing that he had a significant financial stake in the product. Nemeroff said that he would have disclosed the conflict of interest if the journal had only asked him to:
"If there is a fault here, it is with the journal's policy." (see this coverage in the New York Times).

--2006: Nemeroff co-authored a positive review article about vagus nerve stimulation. The Wall Street Journal soon reported that Nemeroff neglected to disclose his significant financial relationships with Cyberonics (the maker of VNS), and that the article itself was possibly ghost-written by a medical writer hired by Cyberonics. This time, Nemeroff could not convincingly blame the journal, because he was the journal's editor-in-chief! He was soon forced to quit the post. (See my article covering the debacle here).

--2007: Nemeroff co-authored an industry-funded CME supplement to the journal CNS Spectrums which his "co-author" Linsey Devane called "ridiculous" and "inaccurate," and he claimed that Nemeroff had encouraged him to be involved "for the sake of selling CME time." (See my coverage here). Eventually, the ACCME determined that the article violated its Standards for Commercial Support because it was biased in favor of the Bristol-Myers Squibb's drug EMSAM.

--2008: Both the New York Times and the Wall Street Journal simultaneously broke the story that Nemeroff had consistently failed to disclose payments from GlaxoSmithKline for promotional talks, even while he was in charge of an NIH grant studying the company's drugs. This led to Nemeroff's resigning his chairmanship of the Emory University Department of Psychiatry.

Given Nemeroff's track record, I am surprised that Tom Insel agreed to endorse his standing with the NIH to Dr. Goldschmidt, the dean of University of Miami's medical school. The proper thing would have been for Insel to politely decline to discuss Nemeroff at all. In today's Washington Post, Insel is backtracking, saying that "I didn't recommend him" for the Florida job. But Goldschmidt's recollection of the phone conversation was that Dr. Insel "confirmed to me that Charlie was absolutely in fine standing" with the NIH, according to the Chronicle for Higher Education.

What a mess for Insel, for the University of Miami, for the NIH, and once again, for Charles Nemeroff. Now Senator Grassley is involved and is requesting all relevant information concerning the relationship between Insel and Nemeroff. Presumably, Insel's lapse of judgment in this matter was a result of his long-time friend "Charley" calling in favors--but exactly what those favors are will be determined once the documents are released.

File this under: "To be continued...."

23 comments:

Uma said...

The Vagus nerve excitation theory has truly inspired me. I'm gonna get me some fleas and scratch scratch all day and soon my nerves will get plenty of excitation and I will be on a natural high.

SteveM said...

The critical subtext is that critics of business as usual are merely impotent gnats buzzing around the Pharma-Academic Leviathan.

Regardless of Dr. Insel's recommendation, Miami knew all about Nemeroff's shenanigans and hired him anyway.

The bad publicity has not hurt Nemeroff, Schatzberg, Biedermann, et al. one iota. Heck, child psychiatrist Dr. Kayoko Kifuji was instrumental in a kid's death and she's back at work hob nobbing with her psychiatrist pals at Tufts.

Getting dumped on by Dr. Carlat and Allison Bass is a minor cost of doing business. Merely swatting flies while lining your pockets if you're Nemeroff.

Senator Grassley though well intentioned, has no regulatory authority. And KOLs like Dr. Ronald Pies dance around the dysfunction and never call a spade a spade by name. Free pass time in the name of "collegiality".

P.S. Re: Uma's fleas - cryptic...

Anonymous said...

This guy Nemeroff is truly a piece of work. I don't care if he is a genius. The Unabomber was a genius too. So was Ted Bundy. Nemeroff seems to corrupt everyone he comes in contact with! I mean, Insel doesn't seem to be a bad guy, but what the heck was he thinking in appointing Nemeroff to study committees??? I think this ends very badly for Insel... and NIMH and Miami. As Emory learned, you don't screw around with Grassley.

Anonymous said...

Dr Carlat, while appreciate your blog immensely, I feel obliged to point out that you may be misrepresenting some of the facts here to your audience. To quote you:

In today's Washington Post, Insel is backtracking, saying that "I didn't recommend him" for the Florida job. But Goldschmidt's recollection of the phone conversation was that Dr. Insel "confirmed to me that Charlie was absolutely in fine standing" with the NIH, according to the Chronicle for Higher Education.

The reason Dr Goldschmidt called Dr Insel was not for a job recommendation, and this has been publicly reported. He called to find out whether Dr Nemeroff was still able to apply for NIH funding, hence the 'fine standing' comment. Dr Nemeroff at this point has not been disbarred from applying for NIH grants, and would need an ORI investigation for that to happen. Although we all agree that there would be a massive public outcry if Dr Nemeroff is the recipient of any more NIH funding at this point; we should all be able to agree that from an institutional employer's perspective, it is absolutely critical for Miami to hire clinical/reseach faculty that are eligible to receive funding.

The points that you are not paying sufficient attention to in this post are several:

1) Dr Insel recently chaired the committee that proposed the new regulations on COI for the NIH, which in my view only emphasizes that you are right in stating that he should never have taken the phone call from Dr Goldschmidt in the first place

2) Emory, Dr Nemeroff's former institution, had prevented him from applying for new NIH funding. This mandate has not been carried over to Miami, and frankly reflects badly on Miami

3)In the face of Emory's mandate, Dr Insel encouraged Dr Nemeroff to continue to apply for funding

4) As you have said in so many other posts, while none of this is openly wrong or criminal (Dr Insel can make a valid case that it woud have been wrong for him to tell Dr Goldschimdt that Dr Nemeroff was ineligible for NIH funding), it's really about the image. What this leaves the public seeing is an old boy's club. Dr Nemeroff lobbied hard in 2002 to help Dr Insel's appointment at NIMH, and now Dr Insel appears to be trying to quietly return the favor.

Whether Dr Insel should have taken that phone call or not, it was in his own best interests to remind Dr Goldschmidt that, while Dr Nemeroff was indeed eligible for funding, it may not be sensible to actually apply for it.

Anonymous said...

The bigger picture is greed, vested interest, and the fiction of the meritocracy. The behavior noted by Big Pharma is not unique to this 'industry'--recently we have seen that there was vested interest in Hyping H1N1, and that two of the primary author's of the hype were paid large sums of money by the two providers of the flu shots.

No one talks much about how Billions were spent on this, and this was yet again another over-hyped, yet profitable scare.

Steve M's comment is one the money, "impotent gnats buzzing aroudn the Pharma-Academic Leviathan". Sadly, narcissists and social Darwinists exist in the Medical field, the prestige and money potential of an M.D. is too much to pass up, similar to politics.

Like any profession the lack of knowledge base by the public in general and the elite lingo of the field, provides a shelter of sorts, with few willing to swim counter-current to mainstream thought, nor the stream of money. Being smart and educated, can just make you more of a Machiavellian manipulator, regardless of the field of work.

The big question remains, will Big Pharma control 'research' and will Psychiatrists attempt to follow a more biopsychosocial model of mental health, rather than biological reductionism--and if so, how can the reasonably do so and still get paid what they are used to making? Financial realities are part of why M.D.'s don't do much talk therapy anymore as well, not just more efficacious psychotropics.

How about we start with forcing the Pharma companies to act like Insurance companies, and cap profit margins they can make of the drugs themselves, and force new drugs not to be merely a molecular variant of the exact same substance, and not allow drugs to be immediately re-patented for other uses "magically" as soon as they have to deal with generics.

Joseph Arpaia, MD said...

I am going to play Devil's Advocate here and paraphrase Mark Twain "In a democracy people get the health care they deserve."

While Big Pharma and their syncophants and cronies in medicine deserve criticism, censure, and maybe even jail time, the American public has attitudes which foster that behavior.

Polls have shown that only a minority of people want lower coast care if evidence support that as effective. Most people want more care and more expensive care no matter what the research shows. Look at breast cancer screening. Popular uproar because people didn't like the science. Look at operative procedures for back pain. These are mostly useless or worse, and extremely expensive. In fact more expensive procedures for treating back pain are increasing in frequency despite their lack of success. And patients WANT these. Informing the patient that a medication or procedure is not likely to help them does very little to change what the patient wants.

What about "low T" or low testosterone. Yes this is being marketed, but how much intelligence does someone need to know that maybe the reason they feel tired, have little muscle tone and low libido is because they have spent decades watching TV 4 hours per day and exercising 4 hours per month?

From my perspective the problem with health care is that it makes the agent of healing OUTSIDE of the patient. This is generally the case even for "alternative" treatments: chiropractic, acupuncture, therapy, massage, supplements, ... just as much as it is for allopathic practitioners. As long as the people think they need pills, supplements, procedures, therapy, etc to make them well we are only going to get more of what we already have.

The alternative as I see it is to empower the patient as the source of the healing. This can be done using any modality of treatment, but it will require a complete change in our cultural mindset.

Joseph P. Arpaia, MD said...

Here's another example of the problem. Its not just Big Pharma, its the public, the media, etc, Its the culture.

Post about proton beam therapy and irresonsible reporting.

www.healthnewsreview.org/blog/2010/06/small-town-newspapers-and-the-medical-arms-race.html

Uma said...
This comment has been removed by the author.
Uma said...

Hey Dr. Carlat, how strange that you don't have a fan page on facebook, no groups with screaming supporters even. You should mix with the riff raff like me, we're the ones who will make you famous.

Joel Hassman, MD said...

Your point in this posting? You should be covering how the APA does NOTHING to refute or distance itself from these corrupt individuals, and just cozys up, puts their arms around said individuals, and then recklessly and stupidly defends them, thus embracing the real attitude of "we are judged by the company we keep."

And again, it is painful for readers here to read this next comment, but why do responsible, caring, and ethical psychiatrists belong to the APA as of 2010? End your membership, make them irrelevant, and then who do the Nemeroffs turn to for validation and support?

No one of true and honest substance, that is who!

Anonymous said...

Dr. Joseph Arpaia,

From my experiences, doctors don't emphasize healing from within. I started meditating about a year ago thinking it would help my adhd. I was amazed! That's when I learned there's a very powerful mind-body connection...one that doctors don't acknowledge. It's what we eat and it's what we do. I think if people really knew how much better they'd feel, how much more vibrant and alive they'd feel if they went for a 30-minute run everyday, ate their fruits and veggies, etc...then maybe they'd be more willing to heal from within.

Gina Pera said...

The second Anonymous makes some excellent points.

These are important points that tend to get buried amid the "gotcha" shouting on the Internet, especially with the anti-psychiatry wingnut contingent.

I wish you Anonymouses would at least distinguish yourselves with names -- real ones would be preferable.

Uma said...
This comment has been removed by the author.
Anonymous said...

From AAAS's network, June 16:

NIH Official Denies Any Deal With Disciplined Psychiatrist

A National Institutes of Health institute director says on his blog that there was no "quid pro quo relationship" regarding employment opportunities between him and Charles Nemeroff, a former Emory University psychiatrist who broke federal rules on reporting drug-company income.

Thomas Insel, head of the National Institute of Mental Health, wrote yesterday that a recent story in The Chronicle of Higher Education "suggested incorrectly" that Nemeroff had helped Insel to become director of Emory's Yerkes National Primate Research Center in 1994. In 2009, after Nemeroff applied for a job at the University of Miami, Insel also said he spoke with the dean of the university's medical school "simply to describe the facts" that a 2-year ban imposed by Emory in December 2008 on applying for NIH grants would not follow Nemeroff if he moved to Miami, which Nemeroff did in December 2009. However, Insel says he will recuse himself from future NIH matters involving Nemeroff to avoid any further misperceptions.

Anonymous said...

I'd like to know why the University of Miami put their reputation on the line to help Nemeroff. Could it be because they thought Nemeroff could help their standing as a medical research university by getting more NIH funding, hence improve their national ratings? Seems like a risky gamble to me, which is now blowing up in their faces. Sadly, the priority at University of Miami Miller School of Medicine, is to emulate other so-called 'power house' university medical centers around the country, by placing too much emphasis on NIH money and ratings over quality of teaching or quality of medical care. Does this sound like Wall Street?

John M. Nardo MD said...

Here in Atlanta where Dr. Nemeroff rose to stardom, it's as if he was really never here in the first place. Those of us on the clinical faculty still do what we did 20 years ago, before he came. I try to recall something I learned from him during his tenure, but nothing comes to mind. The saddest part of this saga is that it was all much ado about nothing, yet it did a great deal of damage to our profession and our patients - as you have quoted, changing us from "brainless to mindless." At issue, having lost our minds, how do we get them back?

Uma said...

To quote from the Washington Post article "huge private-sector bucks flowing to researchers at universities and institutes and the like" If the bucks flowed to Researchers and not to the Universities/Institutes, then why is the institute barred from funding and not the researcher? The immunity that these researchers enjoy is all the more reason for them to carry on with their dishonesty and leave the institutes (and in turn the other researchers) to suffer the consequences. Or did I get this wrong?

Anonymous said...

Gina,

The name calling really needs to stop. It serves no purpose whatsoever.

For the record, I am not anti psychiatrist. I am anti professionals who don't understand that patients are not the same. If they can't tolerate a treatment, they shouldn't be looked at with total disregard and offered more of the same old, same old.

This includes psychiatrists, alternative health professional, and regular doctors.

As far my using a my real name, I don't because I don't want future employers reading what I post on the internet. In this tough job market, I simply can't take that risk.

But I do use the same unoriginal screen name:) on this blog to make things easier.

Dr. Arpaia, you make some good points. My family had that mammogram discussion and a few people (not moi) were not pleased with the new guidelines.

However, you can't put it all on the patients.

As an example, former co-workers were offered medication for extremely borderline conditions. They rejected the offer so they could try diet and exercise.

Finally, Dr. Hassman, great point about psychiatrists not belonging to the APA.

AA

Stephany said...
This comment has been removed by the author.
Anonymous said...

Nemeroff turned Emory's Department of Psychiatry into a world class operation, and he will do the same at the University of Miami. In the end it's all about the science and the body of work, and there are few who are or who will ever be in his league.

What's a four letter word that ends in "NVY?"

Anonymous said...

Dear Gina,

I know that myself and several other Anonymous folks that post comments to these and other blog sites would like to be able to give you the transparency you deserve. However, you should consider the possibility that it would be unwise for some of us to do so. I am sure that you have no fears at all about having your real identity disclosed over the web, but there are very real consequences for some of us should word of what we discuss get back to our employers and other people who could use it to our detriment.
Sorry, but this is just the world we live in; I didn't make it that way, I just try to live here.

Anonymous said...

To address a few issues:

1. "You don't screw around with Grassley." Grassley and his staffer Thacker are bullies with political agendas pure and simple. When Grassley went after the televangelists over their tax-exempt status they pushed back,and pushed back very hard, punched him in the nose, and he ran away just like bullies do. It's time for people to stop cowering and putting up with this nonsense. He'll go away and find someone else to torment.

2. I would much rather see a psychiatrist who had relationships with dozens of pharmaceutical companies than one who has a signficant (financial) relationship with only 1 or 2. And I definitely would not want to see a psychiatrist who was blatantly anti-pharma. A psychiatrist with multiple relationships is much less likely to be biased around treatment considerations than one who is deeply tied to a specific company or one who hates all of pharma. For example I would trust Dr. Nemeroff to be my psychiatrist or to treat any member of my family before I would let Drs. Carlat and Goldberg treat my family and me.

Smitty said...

I'd like to see more on Insel. Especially now that he has an article in Nature, and a blog on the NIMH website, finally admitting (in the most delicate of ways).... that the medication model for treating psychosis was ineffective and we are ready to use new tools.

My psychiatrist, interestingly, never said a word about this article when I saw him on Wednesday, which, if we hold psychiatry to its words, should be part of a whole new wave of hope.

That we have hope and real logic for the treatment of schizophrenia is HUGE for all of psychiatry.

Many of us with a vulnerability to psychosis have ruined lives. How will this affect those who have been told a mistruth about the need for lifelong medications, paid for by Uncle Sam? And back on a path of meaning and purpose?

What a travesty of a system. I had to do my own advocacy. In my court, were two old school therapists who had insight and faith in me. Also I have a husband who listened to me and did not simply tell me to "take my meds", when my body told me they were not what was getting me well.

Still, I got to tell you, it was one crazy ride. I kept asking myself, why me? Why do I get this challenge?

I wasted only seven years of my life, holding my ground and insisting that I get off medication, under the doctor's watchful eye. I knew that there had to be a reason for my repeat psychoses. I did not believe the medications did anything for me, except restore sleep. Turns out I was right. I was perimenopausal. Another obvious truth the doctors don't admit is that big hormonal fluctuations set off alarms in the brain, that can involve psychosis. I had to tell my doctor that this was the case for me! And by the time I really knew it, it was too late to get data. I was in menopause. And I was dealing with unresolved story and dysfunctional beliefs that I had learned from a parent who fits all the criteria for Borderline Personality Disorder. These are huge factors, that I am glad I was able to discern for myself.

For years, I fought this battle, getting quietly educated. I did not read Whitaker's first book until 2005, but that book helped me to take back my power.

Thank God, we are here at last! Maybe NOW we can get to the bottom of why EACH patient has psychosis, and thereby help them to understand how to prevent it.