I want to ensure that Emory and/or Dr. [Charles] Nemeroff are fully aware of the penalties for making false statements and/or obstructing Congressional Investigations. (Senator Grassley in Letter to Emory University).
These are the type of heavy handed tactics Senator Grassley is using against Emory University regarding their letter answering the Senator’s questions by Jane Jordan, Deputy General Council. Ms. Jordan basically wrote that Emory, though respectful of the Senator’s position, disagrees with the Senator’s conclusions that Dr. Nemeroff was malfeasant in his duty by failing to report speaking payments to Emory, who in turn, must report financial interests of clinical investigators working on National Institutes for Health (NIH) funded grants.
In her response, Ms Jordan gave several compelling arguments why Dr. Nemeroff’s speaking engagements were, in his and the University’s view, not considered promotional engagements and thereby not subject to reporting rules.
Though the Senator and media have acted as if they were foolish in their response, their arguments around confusing rules should be considered:
No Research Bias or Compromised Patient Care
They do not believe that Dr. Nemeroff’s participation in the compensated speaking arrangements with Glaxo Smith Kline (GSK) in any way biased the research conducted under the grant.
Dr. Nemeroff’s talks were substantively focused on medical education and were not product-specific or promotional.
Emory thinks that Dr. Nemeroff should have disclosed the payments he received from GSK, but believes that both the regulations (Health and Human Service (HHS)) and the policies (Emory) were insufficiently clear at the time that one may think that they were in compliance without being so.
Dr. Nemeroff basically gave four talks that were non-promotional in nature which focused on science and not drug-specific. This is despite the fact that he was paid out of a promotional budget.
Dr. Nemeroff’s interpretation of the relevant regulations and policies were unclear
Dr. Nemeroff contends that the relevant HHS regulations and internal Emory policies were not clear with respect to obligations to disclose fees received from talks of the type he provided to GSK and others, which he classifies as “ and thereby exempt from disclosure.
In the response to categorizing Dr. Nemeroff’s speaking engagements as CME like the Senator wrote: Neither anyone on my staff, nor any medical expert that they have contacted, have ever heard of the term CME-like and thereby exempt from disclosure.
This is potentially a huge issue, many doctors give promotional talks based on their own slides. They go out of their way to make them fair and balanced, not favoring any one point of view, and most importantly, they would never present the company slides. So, in their minds, they are not giving promotional talks which is probably true, but given that payment, audience and venues for these talks are directed by sales and marketing, by its very nature, makes them promotional talks and for the legal departments at pharmaceutical companies, this is what they reported to Senator Grassley.
This issue also may also become exasperated as companies move into providing more “non-branded disease state education” which is CME like — not product specific and not promotional in nature, but driven by the marketing departments within the companies.
They point out that the policies admittedly do not expressly address “speaking fees paid by for-profit companies” as a distinct category that must be reported. Apparently, Dr. Nemeroff contends he is not obligated to disclose to the Emory School of Medicine his compensation from GSK and others.
Emory is Strengthening its Conflict of Interest Management Process
Emory has moved the management of conflict of interest to the Office of Research and Administration.
They are re-evaluating their current practices.
They sent out a letter to faculty that new financial disclosure regulations will apply to faculty on new and pending NIH Grants.
Dr Nemeroff has voluntarily stepped down as chairman of the Department of Psychiatry and as Principal Investigator on NIH grants at Emory.
Earlier this year, I thought this was a clear case of malfeasance but now after closer review, we should all consider that the ambiguity built into the system is largely to blame for most of the “missing disclosure.” There is probably no malfeasance here, and in the grand scheme of things, what does any of this accomplish?
On another semi-related issue, Senator Grassley has sent medical Publishers, Wiley and Sons, a request for information concerning journal supplements and Dr. Nemeroff. Apparently, Dr. Nemeroff, who is the journal editor of Depression and Anxiety, wrote a memo to himself in 2000 to give himself compensation for writing a journal supplement honoring the 10-year anniversary of Effexor, a commonly used anti-depressant. At the time, Nemeroff was the Editor of the Journal so it makes sense for him to document that he was requested by the Editor, though in retrospect, it does look rather foolish.
The Senator stated in his letter to Wiley and Sons:
One thing that concerns me in this scenario is that supplements, such as the one edited by Dr. Nemeroff, may soon be used to promote drugs off-label.[5] I am attaching the pertinent FDA draft Guidance on the dissemination of off-label information for your review. Because of this concern, I am writing to inquire about Wiley’s policies that address, among other things, honoraria payments to authors to write articles for your company’s journals. I would also like to understand Wiley’s conflict of interest and disclosure policies, requiring authors and journal editors to report outside income received.
In 2000, the disclosure rules were very different than they are today. Given that Effexor XR’s patent expires in 2011, two years from now and the articles are nine years old, this probably was never an issue that Wyeth or anyone else would pay to distribute journal supplements that are that old.
Of course, the Senator fired off another letter to NIH demanding more investigations be done on Emory regarding the $3,000 for the journal supplement, and the phrase they used to justify Nemeroff’s talks as “CME-like” (if you don’t like the answer you release the hounds).
I agree CME-like is an absolutely poor choice of words, but hardly worthy of the Senator’s time.
With the banking crisis, the pending bailout of the auto industry, AARP raking in over ½ one-half billion dollars from insurance companies, Madoff stealing billions, among other things, please help me understand why issues like a $3,000 payment for a journal supplement would even be on the radar screen of the ranking minority member and former chairman of the Senate Finance Committee who states his goal is to oversee the proper administration of the programs, including the payment for prescription drugs regulated by the Food and Drug Administration.
Perhaps Congress has gotten caught in the trees (conflict of interest) and can no longer see the forest (healthcare expenditures and financial crisis).
These investigations get articles in the New York Times and The Wall Street Journal for politicians. It is possible that parts of these investigations when read in context could these be perceived as baiting rather than truly looking out for the public’s interest.
Key Documents:
Wall Street Journal Blog: Dear Me,’ Nemeroff Wrote Himself About Payment for Effexor Article
Wall Street Journal Blog: Grassley Blasts Emory over ‘CME-Like’ Defense of Nemeroff
Pharmalot: Glaxo, Nemeroff and CME like Promotions
Original Documents:
Emory University Emory University Letter to Senator Grassley 12-05-2008
Grassley Letter to Emory University 12-17-2008
Grassley Letter to NIH on Emory 12-17-2008
GSK Letter to Senator Grassley 12-10-2008
Grassley Letter to Wiley and Sons Publishers 12-17-2008
Grassley instructions to Wiley and Sons Publishers 12-17-08
FDA Draft Guidance Distribution of Journal Articles 2-2008
Letter from Nemeroff to Himself
Nemeroff Payroll Request to Emory
Depression and Anxiety Supplement – Nemeroff Article 2000