NIH Requires Emory To Disclose All Conflicts
34 CommentsBy Ed Silverman // October 13th, 2008 // 4:31 pm
In the wake of the investigation by the US Senate Finance Committee into Emory University psychiatry professor Charles Nemeroff, the National Institutes of Health is now imposing new conditions before agreeing to award grants to the university, according to an October 10 memo sent to faculty.
An NIH regulation requires researchers to report to their universities any “significant financial interests” they hold in research financed by the agency - defined as income or equity interest of $10,000 from a company or 5-percent ownership of its stock. The universities 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.
The committee is investigating Nemeroff’s alleged failure to fully disclose payments from Glaxo while simultaneously conducting research into Glaxo drugs, and Emory’s failure to take any action even after conducting an internal inquiry (back story).
And so last week, David Wynes, Emory’s vp for research administration, wrote that the NIH won’t send any funds unless full disclosure is now made by all professors. You can click to see the actual memo or read it right here…
From: All Emory University Faculty [All-Faculty@emory.edu]
On Behalf Of Johnson, Julie [JRAE@emory.edu]
Sent: Friday, October 10, 2008 3:10 PM
To: All-Faculty@emory.edu
Subject: FCOI Letter to Research Community
Sent on behalf of David Wynes, Vice President of Research Administration. The text of the letter is included below in the event you are unable to open the pdf format.
October 10, 2008
Members of the Emory Research Community:
As you may know, the University has been under scrutiny in connection with our business practices for the management of research financial conflict of interest. I am writing to you to notify you that as of October 8, 2008 the NIH has imposed special award conditions on all awards made to Emory University. The special award conditions will affect both the submission of proposals to the NIH as well as the receipt of funding.
In accordance with the October 8, 2008, letter, Emory must submit to the NIH an institutional assurance of compliance for each pending competing or noncompeting award. Every institutional assurance must provide the following information:
1. A list identifying every Investigator participating in the research project, including, if Emory is carrying out the research through subgrantees, contractors, or collaborators, those Investigators working for such entities;
2. An assurance that OSP has on file for each identified Investigator on each project an Investigator Report of Financial Interests in Research; and/or
3. If a financial interest related to the project has been identified for any listed Investigator, a description of the financial interest and the actions taken by Emory to manage, reduce or eliminate any actual or perceived conflict of interest.
The NIH Institute or Center from whom funding has been sought will not issue an award until the institutional assurance and relevant information has been received. As used in these requirements, “Investigator” means any individual named in the grant budget, and/or any person whose biographical sketch is included in the application.
The Investigator Report of Financial Interests in Research form can be found on the OSP web page at:
http://www.osp.emory.edu/shared_web/forms.cfm.
It is important to note that, in the future, OSP will non submit any NIH grant application until disclosures have been received for every Investigator participating in the study. Under federal regulations, submission of the grant application constitutes an assurance from the University to NIH that all disclosures have been made in advance. All certifications must include the original signature of the investigator.
Any questions regarding the submission process may be directed to Sarah White in the Office of Sponsored Programs at 404-712-3027.
We appreciate your cooperation as we work to ensure that we work to demonstrate Emory’s commitment to compliance with NIH regulations and requirements.
Sincerely,
David L. Wynes, Ph.D.
Vice President for Research Administration
cc: Earl Lewis, Provost
Fred Sanfilippo, EVP for Health Sciences
Chris
the same thing should be asked of all other universities that are on the NIH payroll. Harvard, yale, columbia, duke, stanford and the rest of the “medical elite” that are full of KOLs raking in hundreds of thousands, if not millions, a year! The Big Pharma and Medical Device companies have been laying it on thick for years in order to attenpt to influence opinions. The big checks have been flying into the hands of the KOLs. The system stinks of corruption. Let’s bring it all out in the open!
Who knows. It could help the IRS collect a bundle in back taxes and penalties!
Phrma ResearcherIII
I agree. There is no doubt that Nemeroff’s rap is particularly bad. Everyone says that he is greedy to a point of disgust, eating money for breakfast, lunch and dinner. He has done it for years and everyone seems to know his deal. It is sad because the damage to credibility is substantial. But I work for a big pharma company and we have 15 or 20 Nemeroffs as well. Guys who sit on prestigious departments or guideline writing seats but at the same time take millions in dollars from pharma — a hundred thousand or so for speaking engagements, another 200k for consulting, 350k for invesigator services, 250k in grants etc etc. Nemeroff is simply a sample. But when you read these stories it makes it sound like Congress, the NIH and even the media found the proverbial needle in the hay stack. Get real. I could name 15 to 25 KOL’s off the bat who my company uses in the same way every single day. I have seem KOL plans where all of the activities and arrangements necessary to keep the KOL busy are all mapped out to ensure that the relationship stays solid. And it has nothing to do with advancing science. It is about keeping the Nemeroffs of the world rich, happy and working for the cause!! And the problem is that these folks really do influence health policy and health decisions on a large basis. They write guidelines and speak at major congresses. People listen to them. We need to find a path back to scientific credibility, separate and apart from the cash.
Ed Silverman
Dear Phrma Researcher III,
Thanks for the note. And if you want, drop me a line with some info about the other KOLs. I’m all ears and eyes.
Regards
ed
Christopher
Phrma Researcher III - maybe you should leave pharma and go work in non profit if scientific credibility is your main criterion. I say that not as a vehement pharma guy (I’m not) but because I don’t believe “a hundred or so [thousand] for speaking engagements” (how many?) and the rest. Nor do I accept that KOL arrangements are structured to keep them rich - of course not. It’s to keep pharma’s interests alive but I dispute that it’s not to advance science. That’s far too broad a statement and wrong in most cases. Look, it happens and it happens with the more financially driven docs as we know. And yes, some of them are in it only for the money. But not all are and some of those, surprisingly, might have opinions worth listening to. I have worked with more of these types, I suspect, than most on here. Believe it or not, only 10% or so are ones who should be sent to St Helena; the rest are just like you and me.
Phrma ResearcherIII
Christopher — Fair Points to a degree.
Of course, a lot of work with KOLs is to advance science in one way or another. We develop and promote medicines so of course we will need to rely on outside medical experts for many tasks. Most importantly, physicians serve as investigators for important and ground-breaking clinical trials. Absolutely, that is advancing science. So if I implied that none of it is about science then I apologize. That was certainly not my intent.
And that’s what is really sad about the Emory situation and many others like it. You have hundreds of medical experts who are focused n the science and could have supported Glaxo’s efforts. Why Nemeroff over and over and over. Yes, I am sure that he offered some real expertise. The problem is not that Glaxo turned to an outside expert for assistance. The problem is that they seem to have used the same KOL in every way they could imagine. And you have to ask yourself why? Was he genuinely the one expert in the country who had the expertise?
I have seen too many situations where advisory boards are held on a genuine topic. And there will be many KOLs who have great expertise to offer. But you will see (for example) that the KOLs who write guidelines will be selected, over and over. And you start to see a pattern of financial influence that is concerning. So yes, there is often some science to be advanced, but the mix and selection of experts is targeted to keep inmportant relationships strong. And then you see the same guys being selected as promotional speakers etc etc and all the money adds up.
Of course, the problem with a forum like Pharmalot is that you cannot discuss real examples without putting yourself and your company in too much danger. So I cannot answer your post with any real facts. Unfortunately, and I honestly mean that, you will see the facts for real if any of the transparency legislation passes. I don’t get involved in politics and I have no idea if it will happen but if it does you will see some concerning things.
I worked on a big product (billion+). The company had over 1300 physicians who were paid to give promotional speaker presentions over dinner. The fees were in the range of $3,000 per dinner (more for top KOLs) and we had many speakers who would work 30 or more times in a year. So on the speaking tours alone, they could make $100k. And this was for a very mature product. Most of the time we ended up with nurses and office staff at the dinners because there was nothing really new to share with physicians so they wouldn’t even come. But we pressed forward because we had to keep the KOLs engaged and happy. Then on top of the speaking tours, you add advisory boards, clincal trials and lots and lots of grant money.
I am sorry, I know you think that simply can’t be true. You can stick you head in the sand and say “No, it can’t be. Nemeroff was just an exception. It’s all about the science.” But you are wrong. I wish you weren’t but you are.
And of course I think about leaving PhRMA. But with all do respect, I work extremely hard and do my job. I have worked on some important new and successful medicines. While I criticize some aspects of PhRMA, there are really great parts of it. I elect so far to remain on board and do what I can every day to try to make it better.
There are people who can ONLY think about the money and the stock price and then there are people who ALSO think about patients and the science. Sadly, over the last 10 years or so, the first set of folks have taken over big PhRMA. Sure they can all make great speeches about their passion for the patients, but it’s just good PR. These are the folks who take millions of dollars from the medical budgets and throw it at DTC ads in desparate attempts to hit budget numbers. These are the folks who believe every dollar we spend on “science” should be a dollar spent building a relationship with an influencial KOL. And from reading the press, one can imagine that these are the kind of folks who compelled really bad decisions around Vytorin.
The good news is that many of the other folks are still in PhRMA, trying to keep a focus on the science. And it is my great hope that there will be a transformation. It will be painful. But I genuinely believe that the companies who survive the next 10 years will be the companies that get back to the science. The others will learn painfully that DTC ads and influencial KOLs can’t save you if you don’t have genuinely novel therapies to offer.
Of course, these are just the views of one simple person. I have been in pharma for a long time. I have my standard lunch crew. We are not leaders or executives. We talk about the issues and we all hope for something better. We hope every day for stronger leaders. We do our jobs and try to stay focused on what we think is important. But the folks running the show are far smarter than me. Perhaps they see things in the future that I cannot grasp. I could be missing huge factors. I am not suggesting that I alone am correct. I am just sharing my personal views to get mixed up with all the rest in the hope that a once great industry can find a path past Vytorin and Vioxx, past Nemeroff and Emory, past the investigations and CIAs for Cephalon, Lilly, Schering, Bristol-Myers and how many others.
I respect everyone’s views even those that sharply disagree with my own. I am not an expert, I know that. But the folks who can see no wrong need to be able to answer the question why is the industry’s perception so poor and what do the leaders in PhRMA need to do to change it? What should they have done last year and the year before and what do they need to do now? Because there’s no excuse for it.
Christopher
Phrma Researcher III: I think you make some very good points and thanks for expanding on your earlier message. Doesn’t matter whether we agree or not really but something you mentioned - about the industry’s reputation being so poor - made me think more.
Those of us on here generally have an interest if not involvement in healthcare/pharma and so we are more involved, informed, or opinionated than many. And a good percentage of commentators on here are down on pharma in a big way. I just wonder if what is written here - Ed included - represents the way others not in our world fel about the pharma industry. Who monitors opinion? Who checks what the public believe or feel about pharma? I really do wonder if ‘the public’ feels strongly one way or the other.
I do believe though that PhRMA in the US (the trade group, not you) and other industry groups in Europe could and should advocate more effectively for the industry. Even if there is less of an image problem than we all appear to believe, more constructive information and programs from these groups would be a good thing.
Melody
When so many of the “rewards” now passed out within university systems are tied directly to the amount of ‘revenue generated’ by accessing government funding and private corporate underwriting, how can the current system be altered?
[Today’s HCRenewal article http://hcrenewal.blogspot.com/2008/10/nemeroff-case-vs-anechoic-effect.html#links explains how influence-peddling has co-opted our healthcare system and our universities.]
Lisa Van S
Christopher,
If you want to see things more clearly,.. may I suggest you take the blinders off!
truthman30
Looks like Bob Fiddaman has an interesting new post on his blog :
http://fiddaman.blogspot.com/
http://whsc.emory.edu/_releases/2003september/paxil.html
Any comments on this Doug ?
Christopher
Lisa,
You prove my point.
Doug Bremner MD
Truthman: Just to reiterate what I said before, my disclosures are on my web sites, you can follow the links to see the topics of my research, which include (gasp) the effects of paroxetine and other medications on the brain, which has in the past (not currently) been funded by grants from GSK. I am not on any speaker’s bureaus, or advisory boards, and I posted here yesterday that I got dropped from giving talks several years ago because I didn’t want to use exclusively company generated slide sets, as I viewed that as the use of academics for marketing.
Lisa Van S
Christopher,
I am not against Pharmaceutical Products, My brother takes medication for his advanced MS. My Mother takes medication for cardiovascular disease and a seizure disorder, and the medication carries a warning for increased risk of suicide, in her case, benefit outweighs risk. And I personally prefer Pfizer’s Zithromax over the generic brand.
Consumer’s just want the truth, the whole truth, and nothing but the truth. How many children’s lives could have been saved if Dr. Nemeroff hadnt been so dishonest and greedy?
Why are you so against Informed Consent?
Christopher
Lisa
Just a quick response. My point was that you, like me and others on here, are more opinionated than many because we have a vested interest in the industry. Some for good reasons, some not. I do understand your own story: I’ve been on here for a year or so. I wasn’t suggesting anything else.
And I don’t understand why you think I am against informed consent. It’s a legal requirement for a subject/patient’s participation in a clinical trial, a you know. I thought the discussion was about Emory’s disclosure demands of its faculty.
Lisa Van S
Dr. Bremner,
Are you familiar with a Paxil study conducted on children and adolescents where brain scans revealed that paxil actually caused atrophy of the brain, and so called experts stated that that was probably a good thing. Common sense tells us that any alteration of a child’s brain is not a good thing.
Paxil good for memory? Paxil took away my daughter’s ability to speak french fluently!
Lisa Van S
Christopher,
I apologize, I read to much into your comment.
Doug Bremner MD
Lisa Van S
No, I am not familiar with that study. I don’t know your daughter’s history but I am sorry that she had a bad reaction to paroxetine.
truthman30
Doug…
I , like Bob and many others , was prescribed Paroxetine (Seroxat/Paxil)
I was on it for four years, I can not describe in words the damage that drug did to my body and mind, I was barely over 20 at the time, and I can assure you, it does not have any benefit , it is a disgusting drug with disgusting side effects, it should never have been licensed and it should have been banned a long time ago..
I would be interested to know what you think of paroxetine now?..
truthman30
Dr. Bremner,
Are you familiar with a Paxil study conducted on children and adolescents where brain scans revealed that paxil actually caused atrophy of the brain, and so called experts stated that that was probably a good thing. Common sense tells us that any alteration of a child’s brain is not a good thing.
Paxil good for memory? Paxil took away my daughter’s ability to speak french fluently!
Study 329 is the Paxil study which proved Paxil to be ineffective in teens and cause them to self harm and kill themselves Dr Bremmer..
I am surprised Dr Bremmer is not aware of it..
It’s only the most notorious clinical drug study of the past decade..
http://www.healthyskepticism.org/documents/PaxilStudy329.php
I would also like to make Dr Bremmer aware of a norwegian study done in 2005, this study indicated an increase in suicide in the adult population from Seroxat..
http://truthman30.wordpress.com/2007/04/30/seroxat-link-8-the-norwegian-adult-suicide-study-2005/
There were also recent studies indicating all SSRI drugs can cause make men infertile? ..
http://www.newscientist.com/article/mg19926754.500-antidepressants-may-harm-male-fertility.html
What do you make of all this Doug?…
Do you still stand by your (Glaxo funded) study on Paroxetine now?..
Do you think these poison pills are good for our health and good for or brains?…
Lisa Van S
Truthman,
Dont be so hard on Dr.B,… He appears to be a Psychiatrist w/a heart,.. a rare thing nowadays.
Doug Bremner
Hi all. yes I am familiar with study 329 and I have written extensively about suicidality and antidepressants as well lack of efficacy of paroxetine in teens - I am sorry Lisa that those study results were not released Lisa but that was not my personal decision. I put articles on those topics on my website if you don’t want to get my book.
truthman30
Truthman,
Dont be so hard on Dr.B,… He appears to be a Psychiatrist w/a heart,.. a rare thing nowadays.
You think that was being hard? ..
I have no problem with Dr Bremmer, I just wanted to hear his opinions on Paxil now, considering all the negative research of the past few years…
I would be interested in his opinion thats all..
Lisa Van S
Dr. B,
I have actually purchased several copies of your book and yours was the first I had seen that discusses the issues in regards to Valerian.
I dont hold you responsible for the Paxil Studies not being released, I blame GSK.
When you make revisions to your book, may I please suggest that you do a more in depth discussion of SSRI’s in children.
Doug Bremner MD
Thanks for the suggestion, Lisa.
Truthman, your links to infertility and paroxetine are not working. Otherwise I think I have addressed everything on my website/book. And I will be addressing Bob F.’s comments on my website next. I do not consider myself an ‘advocate’ for paroxetine, or any other medication for that matter. I try and inform people of the true risks and benefits of medications. In general I think the picture tends to get tilted toward an overly rosy picture of the benefit/risk ratio, and I try and provide a more accurate view of benefit/risk that in my opinion is free of commercial bias.
truthman30
There are many more links to that research , as its very recent ..
http://www.guardian.co.uk/science/2006/oct/24/medicalresearch.drugs1
I wonder how long the manufacturers of these SSRI’s have been sitting on their own studies?…
And more importantly what information have they not disclosed? ..
Just wanted to ask you Doug?..
Do you think from your own research that SSRI’s are good for the brain?, as in cognitive memory etc..
Because I can tell you from experience that 4 years on Paxil almost destroyed mine..
So i fail to see how your research could come to its conclusion..
Call me cynical if you want..
But it seems to me that psychiatry makes money promoting these medications , and then even the psychiatrists who disclose the truth about teh side effects , they make money from divulging that angle..
So its a win win situation for you guys..
Unfortunately the patient and sufferer is the one who bears the brunt of all of this ..
Treat a patient with an experimental drug , promote it from drug industry funding, mess a patients life up, then admit the side effects and get paid for speaking about that..
Sounds like a cushy number to me…
Doug Bremner MD
Truthman30, I don’t know your history, or your name for that matter. I am only involved in studies of adults with PTSD, who suffer from memory problems, and for whom it seems to help memory function on neuropsychological tests. I haven’t heard alot about memory problems, although I have gotten some comments on that recently, and answered them on my web site. In my experience, usually memory gets better, but I couldn’t exclude the fact that it gets worse in some people. I am always open to new information from people who are actually taking the medication
truthman30
Thanks Doug..
I noticed the replies on your website..
Interestingly too, I noticed you are promoting a book you wrote about “side effects of medications” , am I correct? ..
It’s called “before you take that pill” ..
Why the drugs industry may be bad for your health..
http://www.beforeyoutakethatpill.com/
Do you not think it is ironic that you, as a psychiatrist, are cashing in on an epidemic which your profession created? ..
The epidemic I am referring to is one of over prescription of psychiatric drugs to every Tom, Dick and Harry for the last two decades…
I have always thought psychiatrists to be opportunistic but this kind of thing goes beyond the pale..
It is absurd ..
You originally promoted Paroxetine (and yes that is Paxil and Seroxat, they are the same drug Doug) and now you are coming out and cashing in on the side effects which were not originally disclosed by pharmaceutical companies who funded your research..
As I said call me a cynic if you will..
But, to me this looks like jumping on the bandwagon..
Peter Breggin, David Healy , Joeseph Glenmullen and Michael Corry have put their careers at risk for decades now because they spoke out against the dangers and risks of these medications, they stuck their necks on the chopping block because they told the truth when it was taboo to do so..
And now, the truth is well known , you decide to write the “definitive new drug guide” ..
Seems like psychiatry cashes in no matter if the drugs work or not..
In any other industry this would be perceived as lunacy…
I guess the cuckoo’s are lucky they have the internet now , as the nest has been well and truly blown…
Doug Bremner MD
I’m not really “cashing in” that much. I explain why I wrote it in the book, why don’t you check it out from the library. Or read this post, which explains where I am coming from
http://www.beforeyoutakethatpill.com/2008/5/do-we-have-a-prescription-med-problem.html
truthman30
I read your intro from your website Doug ..
And your cause is indeed an admirable one, the more awareness about the deceit of industry the better ..
I do, however, remain sceptical about your research on SSRI’s increasing memory ..
And the fact that it was funded by Glaxo is not the only factor in that..
I would also like to ask you about Akathisia .. Have you observed many cases of the manifestation of Akathisia during your tenure and practice in psychiatry?..
Just curious..
Because, I believe Akathisia is the elephant in the room when it comes to understanding the adverse mechanisms of psychiatric drugs..
Doug Bremner MD
Yes, I have seen akithisia with a several psychiatric drugs (including SSRIs) and it is usually caused by moving the dose up too fast.
truthman30
So you have seen Akathisia with several psychiatric drugs?
I am glad we have established that Dr Bremner..
Some psychiatrists deny it even exists, or at the least some psychiatrists deny they have ever seen it..( but these ones are usually in denial about a lot of things)
I am glad to see you recognize the fact that it does exist, that is at least one positive step on the right direction Doug..
I have experienced Akathisia myself, and I can tell you it is not a nice experience, it is in fact, one of the most inhuman sensations I could ever imagine experiencing.. Try to comprehend an intense agitation, so horrific to the point that you feel your nerves are on fire, you cannot keep still, It literally feels like your very atoms are about to explode..
Psychiatric induced Akathisia in an already vulnerable individual is like lighting the fuse on an emotional time bomb..
Is it no wonder teenagers and children literally massacre themselves in a suicidal (and sometimes) homicidal rage when in this condition..
Their emotions disconnected in an zyprexa haze or a Paxil rage..
Their feelings dislocated from themselves, their mind on the fritz from the psych drug induced nightmares, night after night, their souls in a state of inhibition , reality merging with the horrors of unreality..
A condition exacerbated by a brain and body literally frying from the inside out ..
Is it no wonder people go over the edge from this sensation Dr Bremner? ..
Do you still think these drugs are beneficial Doug?..
Or do you think they are quite possibly .. Lethal…
Doug Bremner MD
Truthman30: I am sorry you had to go through that.
LibraryGirl
Christopher,
You say that you wonder what the general public feels about Pharma. I AM the general public. I have worked in libraries for over 20 years and have provided research assistance to some very respected doctors in the field of psychiatry. Because of what I have learned from them I read journal articles published by scientists in a much different and more enlightened way. I now look for COI statements to help me to determine what vested interests the authors may already have in the product they espouse. If their involvment is obvious I take what they say with a grain of salt. I no longer believe that everything written by scientists is for the greater good of the patient/public (me) and I feel a need to determine the degree of their authenticity. So, as a member of the ‘general public’ with no scientific ties to any research I feel that Pharma has indeed been successful in buying the opinions of researchers and I have lost trust in the published medical journals due to this. I have lost my trust in the published word of scientists and this is most unfortunate because now I have to wonder where the general ‘public’ goes to get honest information and who can be believed?
If the regulations become more stringent my belief may be restored, but for now I am saddened by the current trends. I feel a bit more informed than the layman in general, but not much and my respect for the scientific community, in general, has been waning due to these conflicts. Just my two cents.
Christopher
LibraryGirl,
That’s an interesting perspective. It’s a pity that the acts of some scientists and/or doctors have caused you to lose faith with all of them, and the journals that publish them. I may have overstated what you wrote but you seem to suggest that pharma has bought up the integrity of researchers. Surely not all of them - perhaps I’m reading too much into it. But a pity you feel that way. With increasing disclosure regs I understand that it’s expected and required that scientists and researchers reveal the source of funding and support. I think it should not be assumed though that all recipients are swayed or influenced and that their work reflects the wishes of the sponsor. Some do for sure, but not all. So a great shame that your research and screening has caused you to lose faith in the profession as a whole.
LibraryGirl
Christopher,
I did not say I had lost faith in the profession as a whole. Like most people I also have a need in my life for the experts. I have merely learned to question everything I read and to research the research, if you may. I am acquainted with wonderful doctors and researchers and I do believe in the validity of their research. Funny thing is: many, if not most, of them are not ’sponsored’ by Pharma. I didn’t say that I don’t believe anything I read, only that I scrutinize that information in a much more thorough way. This current maelstrom of investigations, to any of the informed public, must bring about doubt in the minds of all. Without this doubt what would precipitate change? Without trust that there is unbiased and untainted data and information where does one go to enhance one’s knowledge? Those are my concerns. Not that there is not “true” and accountable research being done, but that the legitimacy of all research has been tainted by the greed of the few. As a member of the public I would only hope that legitimacy is returned to the profession by eradicating the biased reporting of the few and the greedy so that the legitimate research will once again garner the respect that it deserves. COI MUST be stated clearly and thoroughly for this to occur. With the complete picture about any given research being stated I then have the opportunity to draw my own intelligent conclusions. Without all information being disclosed that opportunity is taken away from me. Therein lies the doubt. Thanks for your response.