What Rules? Emory Fiddled While Nemeroff Earned
31 CommentsBy Ed Silverman // October 6th, 2008 // 7:04 am
For several years, Charles Nemeroff assured Emory University, where he chaired the psychiatry department, that he wouldn’t accept more than $10,000 in consulting fees from Glaxo, since he was the primary investigator on an NIH-funded grant for research into a Glaxo drug.
Why? Since 1995, an NIH regulation has required scientists to report to their universities any “significant financial interests” they hold in research projects financed by the agency. Those are defined as income or equity interest of $10,000 from a company or 5-percent ownership of its stock. The universities, in turn, are required to tell the NIH whether they were able to manage or eliminate the conflicts in order to avoid bias in the research findings (here are the rules). And anxious Emory officials, who conducted their own inquiry, repeatedly reminded Nemeroff of these regulations.
At issue is whether universities are adequately policing disclosures in an effort to maintain scientific integrity and objectivity. The committee is investigating up to 30 academic psychiatrists who allegedly accepted grants from the NIH and consulting fees from pharma, and is leaning on the NIH to yank grants when disclosure is inadequate, a step that recently occurred when Stanford University removed psychiatry chair Alan Schatzberg as a primary investigator.
However, an October 2 letter (see here) from the US Senate Finance Committee alleges Nemeroff regularly exceeded the $10,000 maximum by a wide margin (see accompanying table). The missive to Emory University president Jim Wagner also appears to indicate Emory essentially did nothing about what Chuck Grassley, the ranking Republican on the committee, alleges are repeated violations (see the timeline in the letter).
The Senate has, so far, singled out several prominent academic researchers. But this episode is significant because it may be the clearest example yet where the probe has unearthed not only the alleged undisclosed conflicts involving a particular individual, but the failure of a university to adequately take action despite having recognized a potential problem over an extended period of time (back story).
After all, it was not until this past Friday night - after reports identified Nemeroff as the latest subject of the Senate investigation - that Emory informed faculty that he suddenly stepped down as chair of the psychiatry department. The question is why Emory officials failed to take any action sooner.
laurie
I guess Dr.Nemeroff suffers from Math Disorder…..315.1 with at bit of 313.81 Oppositional Defiant Disorder from the DSM-IV.
Thom
Charlie “Bling Bling” Nemeroff used up the pharma companies like his own personal ATM. Rock on with your bad self, Charlie.
Matthew Holford
You know what I love most about this? The fact that Grassley’s doing all this in public. This, my friends in the Worshipful Company, is the true meaning of the word “transparency”.
And what will the Worshipful Company do, now that this has happened? Will it just latch onto the next generation of KOLs? Trouble is, there is no trust left in the system for the Worshipful Company: the NIH is going to be a bit better switched on. Universities will have no choice, or risk being implicated, as has Emory, Brown, Harvard, etc.; not exactly the blue chip seats of learning that people have imagined them to be - I could get a better education with a season ticket to my local library. And the Senate Finance Committee has developed a methodology for flushing out this sort of scam…
The only question is, how far is Grassley willing to follow the money (ie, how big is his remit)? I doubt he has the authority to follow the money back from whence it came, to find out who put this whole sordid business in motion, but I wish he did. Very systematic, is Grassley: I like his style.
Matt
Insider
Ed - you have been writing some great stuff. Plus your headlines have been marvellous.
All in all: “you are The Man”!
truthman30
Greed..
Thom
Ed, the timeline is quite small when you click on it and hard to read. Can it be made a bit bigger?
Ed Silverman
Hi Thom,
Another way to view the timeline is to click on the link I provided at the bottom of the paragraph taht begins “However, an October 2 letter…” and scroll down to where it says…”(see the timeline in the letter).”
That should allow you to view the timeline more clearly, although I will work on making it bigger.
Ed
Condor
Ed — I echo Jack’s — TREMENDOUS stuff, all through the last few weeks, on this story.
I admit to being astonished by Nemeroff. Not that he took the money — No, not that — but that he was so STUPID — stupid! — as to think that GSK would NOT be reporting it, right along, and that someone, somewhere wouldn’t match the two up.
As to Sen. Grassley’s motives — I think he firmly believes fundamental health care reform is needed — and Dr. Nemeroff just became his poster boy.
Let us hope that Nemeroff is the worst of it.
Honestly, I suspect we are going to learn that he is nto the most egregious case. As more and more companies adopt “Sunshine in Grants” policies of one form or another, more Nemeroff cases are certain to emerge.
Cheers!
PS: Ed — the graphic could run as a single, longish rectangle side-bar on yours — I’ll send you one example, now.
Anon
Ed, Condor.
Sidney said Pharma is dying the death of a thousand cuts. This is just one more and notice how they’re getting deeper.
Grassley started with Vioxx and FDA and this was soon after suicidality with antidepressants. We’re now looking at miscoding of data and hiding safety data, court cases regarding preemption, misreporting of income by key opinion leaders, NIH misconduct, and insider trading and racketeering by SP.
Last spring Rep Dingell intimated to Dr. Von Eschenbach that he would be ’skinned’. Thoreau-FDA has told Commissioner Von Eschenbach that he should come clean and offered him a chance to respond by mid-August. Dr. Von Eschenbach never did and since then more and more has been coming out.
Last year Grassley indicated that multiple $0.5 billion monetary penalties have done nothing, and an article in the Baltimore Sun quoted a capital hill source as indicating an FDA shakeup bigger than anything since thalidomide. Since the generic drug scandal sent over 40 people to prison I think we may still be looking at something coming that’s so big that it will send large numbers of senior people in pharma and FDA to prison.
The question is when is the big shoe going to drop and who will get squashed. The shoelaces were loosened, and are now dropping to the floor, it may not be long until the shoe itself drops.
Justice in MI
Re: Nemeroff, this is the (current) tip of a very large iceberg. Universities almost always “protect” folks like this - they bring in huge grants, name/fame to the U., sometimes a cut of the moolah via other deals with relevant companies, various spin-offs, etc.. The focus on Nemeroff risks distracting from this bigger picture. The “ivory tower” will not look very ivory if this is ever genuinely described.
Re: Anon’s post - whatever one thinks of dropping shoes - my personal guess is that scenario remains unlikely. The entire Congress (including Waxman, Grassley, Kennedy, et. al.) was ready to give away most of what was meaningful to achieve ‘reform’ via FDAAA. But perhaps Anon has better “sources” than I do.
NR
Nemeroff is not the worst of it. It’s so common that the CSPINET integrity database regularly exceeds bandwidth. Bur Nemeroff the worst? What about Troy Sunderland?
And yes Ed. Terrific work. Give the man a raise boss.
By the way Ed, speaking of COI. Have you ever … you know?
Lunch, speaker’s fees, tickets, ad following your editorial?
Note this:
http://www.cbc.ca/whitecoat/2008/09/more_drugs_and_a_confession_fr.html#more
The conflicted Dr. Goldman didn’t post my comment about declaration not being the point.
Meg
Pharma may be dying a death by a thousand cuts, but many have died a death by a thousand pills due to its greed.
bnj
You know, its possible he earned the most money as a speaker because he had the most knowledge and expertise as a researcher and clinician. However, now it is hard to be sure, because he has failed to be honest about the extent of his pharma income. Now his real scientific skills will be trashed because of his poor financial judgment.
I will have to say his arrogance is amazing. he gave a talk in May 08 at the APA meeting, and had the nerve to open with a joke about giving a drug company talk as a young faculty member at Duke…I thought he was treading on thin ice at the time..
susan
i could rant, but this is the crux:
no one should approach the temple of science with the soul of a moneychanger.
-sir thomas browne.
note that this applies to institutions as well as individuals.
Doug Bremner MD
My response to another blogger on the topic:
OK, here is the comment from the Emory professor you were looking for, in, yes, the department of psychiatry. I am not writing to excuse bad behavior, but I did want to write a note before Emory, NIH, and Pharma package up their scapegoat and send him out of town.
NIH: “We don’t have the staff to monitor outside payments” [how about a database, idiots. Doih!]
Pharma: “We are going to voluntarily disclose now”. [thanks for the memories, docs]
Emory: “We are very ethical.” [translate: we watch our backsides and brood about our image]
And yes I am a psychiatrist and a researcher and yes in the past I did get paid hefty fees for giving talks that were funded by the pharmaceutical industry, not as much as what Dr Nemeroff got but not that far off. $3500 for one talk sounds like a lot of money but as a rep for GSK pointed out, it is the going rate for well known speakers, and giving a talk basically takes two days out of your schedule to travel, etc, can be a lot of work.
The reporting, your blog and others are incorrect in terming his work as ‘consulting to GSK’ when it was in fact giving lectures for a CME company. My own lecturing trickled off when I made the pesky demand that I not use ONLY slides that came from the company (they claimed the talks needed to be approved in advance by the FDA) and then ceased altogether when I wrote ‘Before You Take That Pill, Why the Drug Industry May be Bad for Your Health,’ which I wrote in reponse to my experience as an expert on the connection between an acne drug called Accutane and depression. That experience was an inside look at the corruption of pharma and their manipulation of the truth. My reward for stating my opinions (which were detrimental to the bottom line of the manufacturer), was that the manufacturer: 1) sued my university; 2) subpoenaed all my data and deposed me 16 times; 3) accused me of fraud, for which I had to go through a nine month Emory inquiry; 4) subpoenaed emails and documents from colleagues, administrators, my cat, and anyone else who knew me, so that the end result was that noone wanted to know me, and the same administrators named in the current fiasco who are so obviously trying to cover their derriers basically told me to cease and desist, accused me in so many words as being a plaintiff’s whore who did research for money (the affected victims of this drug certainly don’t think so), and that this would affect their ability to get funding from said manufacturer (I had an odd moment where everyone looked around the room once and they said, ‘well we don’t get funding from them anyway cuz we had a contract dispute’). When my book which was a caution about prescription medicaitons came out Emory refused to issue a press release. They wrote one, and they just never released it.
OK, to anticipate the trolls that are going to come on and say that I am self promoting, etc, I will disclose that I signed a letter of support for Dr. Nemeroff to WSJ after the issue about the non disclosure of financial conflicts related to the paper on Vagal Nerve Stimulation in 2004. He said it was a mistake, I took him at his word. Anyway the point I was trying to make is that when I got attacked by said drug company, he wasn’t happy about it, but he did stand up for me in a way others did not.
The other point is that pharma payola and the lack of reporting is wide spread. There is a whole system built around ‘thought leaders’ and ‘talking points’ for reps. Look at cafepharma.com. The reps themselves say things like ‘they send us out the door with 50K in cash in a suitcase every month’ or ‘go look at the key opinion leaders for advair’.
Why is Senator Grassley only looking at academic psychiatrists? I think it is evidence of bias/stigma or what is worse vote grubbing, since psychiatrists have “approval ratings” only above chiropractics. I call on him to examine the pharma talk payola scheme amongst academic physicians in ALL specialties. If he does not he is nothing more than a hypocrite.
I wrote more at
http://www.beforeyoutakethatpill.com/blog.html
Doug Bremner MD
btw people think they need to ’save’ cardiologists because they’save lives’. However the ability of an antidepressant to cure depression is ten times better than the ability of Lipitor to prevent a heart attack. And if you don’t believe me, come on. And any sufferer from depression will tell you that it is just as bad as a heart attack. The fact is that our leading physician scientists are acting like star athletes, complete with lucrative contracts for product endorsements. But the sooner that people like Senator Grassley pull the hypocrisy about how they approach the problem, however, the better.
Christopher
Doug,
I like your ideas. Don’t agree with them all but enjoyed reading them. Looked at your blog and your correlating the Dow with your life (Sept 28). Interesting exercise. Looks like your Dec 2007 contretemps with Roche caused a severe decline in the market to the extreme detriment of the US economy, me included. Whaddya think Doug - any chance of a kiss and make up? Don’t want to be working forever. And more importantly, fully agree with yr note re Grassley whose actions seem to keep the political sceptics energised -as if this week they need any more fodder.
truthman30
Doug..
I would like to ask you do you believe depression is caused by a “chemical imbalance” ?
Or do you think that for the most part depression is basically a reaction to trauma ? ..
I have suffered from depression, and I can tell you that my depression was triggered from emotions and feelings , there were also some stressful and difficult events in my life which compounded it…
So, therefore, being “treated” with an SSRI was for me, nothing but masking the symptoms of my emotions…
I would be interested to know your opinions on this…
Thanks..
Doug Bremner MD
Truthman,
In case you haven’t figured it out yet, the idea that you don’t have enough serotonin and that you can ‘boost’ that with SSRIs is an idea held only by drug reps at this point, and even they know it is a farce. The truth about what SSRIs do is much more complex (they do, however, affect the brain). In my opinion psychotherapy is the treatment of choice for depression related to emotions, feelings, and life events. I prefer the kind that goes on for a long time and that involves talking about your feelings about yourself, your therapist, your mom, your dad, your step mom, etc etc. Americans don’t like pain, tears, death, suffering, etc etc, much to their detriment. One of my personal favorite pastimes is wandering through cemeteries. That said, I do adhear to the theory that clinical depression is real and that it is caused by changes in the brain, as opposed to, say, trolls, or fairies, or bad thoughts you had about your Dad.
I also prescribe SSRIs still, although not as often.
truthman30
Thanks Doug , your comment was actually quite intelligent, reasoned and polite until you descended into a patronizing and condescending tone with this part-
“That said, I do adhear to the theory that clinical depression is real and that it is caused by changes in the brain, as opposed to, say, trolls, or fairies, or bad thoughts you had about your Dad.
I also prescribe SSRIs still, although not as often.”
I sincerely hope that you do not scathe your patients in such a manner..
However, I do agree with you that clinical depression is yes very real, although having being diagnosed with it myself (therefore having possibly more insight into it than you Doug) , I would be of the belief that “clinical” depression develops from your average , ordinary , garden variety depression.
If as you say, “clinical depression” is caused by chemcical changes in the brain, would I be the exception to the rule by believing that my clinical depression developed from my original “depression”.
And further more, knowing that my original depression was triggered by emotional, situational and environmental factors, then surely the root cause of my clinical depression originated in those and not in my brain?…
Personally, I believe that clinical depression is a kind of deep and melancholic grief…
It is not invalid to suffer from it, it is not a disease , it is a protection mechanism..
Yes, it can be chronic, and yes it can be debilitating, particularly when it manifests into its extreme form, as in clinical depression…
The chemical changes (if there are any) are merely creating the brain state to emulate the emotions and the suffering of the mind… They are not the cause , they are the symptom…
I don’t doubt, Doug, that you are sincere in your intentions , but until you have experienced “clinical depression” for yourself, all you will have is assumptions and theories as opposed to real insight. And that insight can only come from people who have come through the darkest clinical depression and lived to tell the tale.
My problem with psychiatry is mainly its approach. It is more of an ideology than a “medicinal practice” . There is little scope for change , and patients opinions are debased and their thoughts and insights are rarely considered.
There is also a considerable amount of arrogance in psychiatry , it has a sinister image amongst a lot of people. The obvious bastardization of the psychiatric profession in regards to pharmaceutical sponsorship and funding does it no favors either…
Doug Bremner MD
I am not sure whether you are more upset about my mention of trolls or SSRIs, or both. I wasn’t meaning to be patronizing: the point I was trying to make is that depression is not caused by mythical beings like the ones we read about in children’s books, however the ability of trolls in the modern sense to cause depression might be another matter. And yes I am aware of the fact that psychiatry has an image problem sometimes. However the ambiguity of the field is what drew me into it in the first place. One thing people might want to consider is that the slings and arrows of outrageous fortune might exist even if psychiatrists vanished from the planet.
Doug Bremner MD
BTW I published my response to Senator Grassley here.
http://www.beforeyoutakethatpill.com/blog.html
Justice in MI
Just a word from a clinical psychologist.
Depression (like cancer) is one word that stands for many different things. It has always seemed to me that some emotional heights and depths have a more _obvious_ base in the soma - for example, people with high anxiety who turn out to be hyperthyroid. Psychotherapy is unlikely to do much for that. Depression may also be associated with metabolic disorderes, certain vitamin/mineral deficiencies, and, of course, drug AEs (beta blockers, etc.).
Once underway, many forms take on a life of their own. So the cause is less important than a tx that can engage the person and their moods. That may be a combination of numerous things.
truthman30
“Once underway, many forms take on a life of their own. So the cause is less important than a tx that can engage the person and their moods. That may be a combination of numerous things.”
I think the cause is very important ..
Particularly when we have Pharmaceutical companies selling SSRI’s on the back of a theory of chemical imbalance, a theory which the good Dr Bremmer has just stated is nonsense…
truthman30
“One thing people might want to consider is that the slings and arrows of outrageous fortune might exist even if psychiatrists vanished from the planet”
These things will of course , always exist..
But that doesn’t justify exploitation and disinformation ..
Justice in MI
T’man - hear you, but, of course, not knowing cause - but having some idea of potential tx’s - is common in medicine.
I understand that when “cause” becomes a promotional tool, that is something else, and your core concern.
Beyond that, and whatever the cause, I have been struck more and more by the role of seemingly disrupted circadian rhytms in many of the more profound depressions. This is not a new idea, needless to say. If a drug was developed with that in mind, I suppose it would have to be called, “Timex.”
truthman30
Thanks Justice ..
I find you usually approach these debates with good reasoning..
And I am grateful for that…
Not to enter weird territory , but their are some esoteric healing practices which concentrate on the heart chakra in relation to depression..
Justice in MI
Hey, some of my best friends are chakras….
Actually, it makes sense, both in relation to circadian rhythms (as viewed from a Western perspective) and what we all know from common expressions - “heavy-hearted,” “down-hearted,” “heart-broken,” etc.
truthman30
Yes, it makes a lot of sense, and in Eastern medicine and esoteric philosophy , the whole individual and the complete being are taken into account when treating any illness, imbalance or disorder..
The Psychiatric model is fundamentally flawed as it only considers the Brain ..It proposes a sick brain model and prescribes ineffective and dangerous drugs along with its ideologies ..
Eastern philosophies and wisdom are thousands of years old , like vedic medicine , yoga and meditation etc..
Where as psychiatry is but a couple of hundred years old..
Natural treatments and holistic practices are hugely successful , of course psychiatry dismisses them and ridicules anyone who discusses them because Psychiatry hold the monopoly on the “mentally ill”
And that monopoly and domain is very profitable for both psychiatry and its pharmaceutical sponsors..
One very insightful psychiatrist whom I do admire is Dr Michael Corry from Ireland..
This is his website for anyone who may be interested..
http://www.depressiondialogues.ie/
George from NJ
His flagrant disregard of the regulations are appalling. He should be prosecuted and severely punished for his actions. Who does he think he is, Al Capone?
Geneve from ATL
I wonder if Grassley and NIH should not start investigating other misuses of public grants, such as investigators starting their own unsuccessful companies around valuable patents, paying nothing to the public coffers…