[Congressional Record Volume 154, Number 160 (Thursday, October 2, 2008)]
[Senate]
[Pages S10467-S10468]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         PAYMENTS TO PHYSICIANS

  Mr. GRASSLEY. Mr. President, I have been examining several doctors at 
universities across the country to see if they are complying with the 
financial disclosure policies of the National Institutes of Health. I 
ask unanimous consent to have printed in the Record my latest letter to 
Emory University regarding Dr. Charles B. Nemeroff and the Emory-
GlaxoSmithKline-National Institute of Mental Health Initiative.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                      U.S. Senate,


                                         Committee on Finance,

                                  Washington, DC, October 2, 2008.
     Hon. James W. Wagner, Ph.D.,
     President, Emory University, Dowman Drive, Atlanta, GA.
       Dear Dr. Wagner: The United States Senate Committee on 
     Finance (Committee) has jurisdiction over the Medicare and 
     Medicaid programs and, accordingly, a responsibility to the 
     more than 80 million Americans who receive healthcare 
     coverage under these programs. As Ranking Member of the 
     Committee, I have a duty to protect the health of Medicare 
     and Medicaid beneficiaries and safeguard taxpayer dollars 
     appropriated for these programs. The actions taken by thought 
     leaders, like those at Emory University (Emory), often have 
     profound impact upon the decisions made by taxpayer funded 
     programs like Medicare and Medicaid and the way that patients 
     are treated and funds expended.
       I would like to expand on concerns I brought to your 
     attention regarding problems with the disclosures of outside 
     income filed with Emory by Dr. Charles Nemeroff, Chair of the 
     Department of Psychiatry. I have previously cited 
     discrepancies pertaining to Dr. Nemeroff's disclosures filed 
     with Emory and reports that I received by several companies 
     regarding payments made to Dr. Nemeroff. I also raised 
     concerns about Dr. Nemeroff's conflicts of interest relating 
     to several National Institutes of Health (NIH) grants.
       Federal regulations place numerous requirements on a 
     university or hospital when its researchers apply for NIH 
     grants. These regulations are intended to ensure a level of 
     objectivity in publicly funded research, and state in 
     pertinent part that NIH investigators must disclose to their 
     institution any ``significant financial interest'' that may 
     appear to affect the results of a study. NIH interprets 
     ``significant financial interest'' to mean at least $10,000 
     in value or five percent ownership in a single entity.
       From the summer of 2003 until the summer of 2008, Dr. 
     Nemeroff was the primary investigator on a collaborative 
     grant between Emory, GlaxoSmithKline (GSK) and the National 
     Institute of Mental Health (NIMH)--the Emory-GSK-NIMH 
     Collaborative Mood Disorders Initiative (Initiative). This 
     Initiative examined five novel GSK antidepressant candidates. 
     The NIH budgeted approximately $3.95 million over this 
     grant's five year period with about $1.35 million paid 
     directly to Emory for overhead costs. Apparently, Dr. 
     Nemeroff also received some payment for his salary from this 
     grant, although the exact amount has not yet been made 
     available to the Committee.
       On several occasions during the life of this grant, it 
     appears that Dr. Nemeroff failed to report to Emory that he 
     was participating actively on the speaker's bureau for GSK. 
     For instance, in an email regarding his outside activities 
     dated October 1, 2003, Dr. Nemeroff wrote: . . . I have to 
     dig up the agreement and send it to you, GSK no standing 
     contract, I chair their ad board 2-3 times per year and I am 
     paid per board meeting at a standard rate of $5K per weekend.
       However, and based upon information in our possession, in 
     2003 GSK paid Dr. Nemeroff about $119,000 in speaking fees 
     and expenses. Based upon information provided from Emory, Dr. 
     Nemeroff did not report that he was giving promotional talks 
     for GSK on Paxil and Lamictal.
       On March 19, 2004, Dr. Nemeroff again addressed his 
     relationship with GSK in response to questions from Emory's 
     Conflicts of Interest (COI) Committee. Again, it appears that 
     Dr. Nemeroff did not mention the fees he was receiving for 
     promotional speaking on behalf of GSK. In a letter to the 
     Assistant Dean for Administration, Dr. Nemeroff wrote: Apart 
     from speaking at national symposia, such as the American 
     Psychiatric Association, for which GSK might serve as a 
     sponsor, my consultation to the company is limited to 
     chairing their Paroxetine Advisory board and for that, I am 
     remunerated $15,000 per year.
       However, on March 16, 2004, three days prior to signing 
     this letter, GSK paid Dr. Nemeroff $3,500 for a talk he gave 
     on Paxil at the Citrus Club, a members only business 
     establishment in Orlando, Florida. On March 17, 2004, he gave 
     another $3,500 talk about Paxil in Kissimmee, Florida. The 
     week after he signed this letter, Dr. Nemeroff gave three 
     talks on Paxil, for $3,500 each, at various venues in New 
     York State.
       In June 2004, Emory's COI Committee released a report on 
     Dr. Nemeroff's company sponsored grants and outside 
     activities. Dr. Nemeroff was provided a copy of the report 
     which stated in pertinent part:
       The Committee concluded that you did not follow procedures 
     and policies regarding the review of your consulting 
     agreements and that you failed to disclose your potential 
     conflicts of interest in research in your Annual Disclosure 
     Form for 2002-2003, your Sponsored Projects Approval Forms, 
     and your IRB and IACUC forms.
       In response to this report, Dr. Nemeroff wrote a memorandum 
     to the executive associate dean on July 6, 2004, explaining 
     how he would manage his conflicts in the future. He included 
     the last page of the COI Committee's report with his 
     signature to indicate ``that I will follow the management 
     plans for my conflicts of interest.'' As part of this 
     management plan, Dr. Nemeroff wrote, ``In view of the NIMH/
     Emory/GSK grant, I shall limit my consulting to GSK to under 
     $10,000/year and I have informed GSK of this policy.''
       Barely a week after this promise, on July 12, 2004, GSK 
     paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for 
     a talk he gave regarding Paxil at the Larkspur Restaurant and 
     Grill in Las Vegas, Nevada. The following day, Dr. Nemeroff 
     gave two more talks in exchange for $7,000 from GSK ($3,500 
     per talk).
       On July 19, 2004, Dr. Nemeroff received an invitation from 
     the marketing team of Lamictal to attend their national 
     advisory board meeting on November 15-16. Dr. Nemeroff 
     responded by email: I cannot attend this meeting, 
     unfortunately for two reasons. First I have a prior 
     commitment presenting grand rounds at St. Louis University on 
     the 16th and a chairs meeting at Emory on the 15th. Secondly 
     because I serve as the Principal Investigator of the Emory/
     GSK/NIMH grant from NIH on Antidepressant Drug Discovery, I 
     am very limited in my ability to consult with GSK as this is 
     viewed as a conflict of interest.
       Records supplied from GSK show that Dr. Nemeroff was most 
     likely in St. Louis on the 16th of November. On November 
     17th, GSK paid Dr. Nemeroff $7,000 for two clinical 
     roundtables at two physicians' offices in St. Louis, and 
     $3,500 for a lecture he gave at Kemoll's Italian Restaurant.
       On July 15, 2004, Emory's Office of the Dean sent Dr. 
     Nemeroff a letter regarding the Emory-GSK-NIMH Collaborative 
     Moods Disorders Initiative grant. The letter concerned the 
     COI Committee's review of his relationship with GSK. The 
     letter stated: The [COI] Committee understands that you serve 
     on the GlaxoSmithKline Paroxetine Advisory Board and provide 
     advice to GSK on their products that are already on the 
     market. For these services, you receive approximately $15,000 
     annually. You do not have any stock options or equity 
     interests in GSK.

[[Page S10468]]

     Please correct the record if this is not correct. . . . The 
     [COI] Committee found that you have a significant financial 
     interest in GSK because your consulting fees are more than 
     the de minimis amount established by Emory's University 
     Policy, the AAMC guidelines, and PHS regulations, which is 
     currently $10,000 annually. . . . In order to manage this 
     conflict of interest, the [COI] Committee requires that you 
     keep your consulting fees from GSK to an amount equal to or 
     less than $10,000 on an annual basis throughout the grant 
     period, its renewals, and final collection of data.
       In response, Dr. Nemeroff sent a letter to the executive 
     associate dean on August 4, 2004. Dr. Nemeroff wrote: 
     However, to reiterate, I have already taken the necessary 
     steps to be in compliance with the recommendations of the COI 
     Committee, namely my consulting fees from GSK will be less 
     than $10,000 per year throughout the period of this NIH 
     grant, its renewals and final collections of data. GSK has 
     been informed of this change and certainly understand the 
     reasons for this decision and is supportive of my compliance 
     with the university recommendations.
       According to GSK reports, Dr. Nemeroff exceeded the $10,000 
     limit within that very same month. On August 23, 2004, Dr. 
     Nemeroff was paid $3,500 for a teleconference with the 
     Louisiana State University Psychiatry Department. GSK reports 
     that this was a ``non product'' talk. However, Dr. Nemeroff 
     gave talks on the 25th and 26th at two restaurants in New 
     York regarding Paxil--one at Passion Fish Restaurant in 
     Woodbury and the second at Burton and Doyles in Great Neck. 
     For each talk, GSK paid Dr. Nemeroff a $3,500 speaking 
     honorarium. On August 31, 2004, Dr. Nemeroff held a ``non 
     product'' teleconference for an additional $3,500.
       On October 29, 2004, the assistant dean for administration 
     sent Dr. Nemeroff a letter concerning his grants. Relying on 
     Dr. Nemeroff's promise to maintain his consulting fees from 
     GSK below $10,000, Emory informed him that he did not have a 
     conflict with the Emory-GSK-NIH Collaborative Mood Disorders 
     Institute.
       However, GSK reports that Dr. Nemeroff's final lecture on 
     Paxil was given on January 26, 2006. That day he gave two 
     talks in Springfield, Missouri. He gave one lecture at the 
     Burrel Behavioral Health and the second at Mille's Turn of 
     the Century Cafe. GSK paid Dr. Nemeroff $7,000 for the 
     lectures along with $174.98 in expenses.
       Based upon information provided to me, it appears that Dr. 
     Nemeroff denied giving these lectures. For instance in a 
     letter on November 20, 2006, Dr. Nemeroff wrote the following 
     to the Emory dean about his outside activities:
       ``I was somewhat surprised by the suggestion that I serve 
     as [primary investigator] or co-PI in any research protocols 
     funded by a company with which I have a financial 
     relationship. This is absolutely untrue. Quite some time ago, 
     I made that decision based on the 2004 letter from Dr. 
     Adkison and have stuck to it. Thus, this is not an issue.''
       However, during the years that Dr. Nemeroff served as the 
     primary investigator of the Emory/GSK/NIMH Initiative it 
     seems he failed to report approximately half a million 
     dollars in fees and expenses from GSK. These fees covered 
     dozens of talks given to promote drugs sold by the company.
       Accordingly, I request that your institution respond to the 
     following questions and requests for information. For each 
     response, please repeat the enumerated request and follow 
     with the appropriate answer.
       (1) For each year that the Emory/GSK/NIMH grant was active, 
     please provide the following:
       a. Total amount of grant;
       b. Amount provided to Emory for overhead; and
       c. Amount of grant provided as salary to Dr. Nemeroff.
       (2) Please provide all communications regarding this 
     investigation and/or Dr. Nemeroff's outside consulting. This 
     information may be held by Dr. Nemeroff and/or his assistant 
     and/or supervisors to Dr. Nemeroff. The time span of this 
     request covers November 2007 to the present.
       (3) According to documents provided to us by Emory, Dr. 
     Nemeroff wrote a memo to himself on the letterhead of the 
     journal Depression and Anxiety, stating that he was paying 
     himself $3,000 to write a supplement for that journal. Dr. 
     Nemeroff then filled out an Emory form for payment, with the 
     money being withdrawn from Emory account 9-30410-2170. Please 
     provide documents and explanation for the source of funds 
     that were placed in this account.
       Thank you again for your continued cooperation and 
     assistance in this matter. As you know, in cooperating with 
     the Committee's review, no documents, records, data or 
     information related to these matters shall be destroyed, 
     modified, removed or otherwise made inaccessible to the 
     Committee.
       I look forward to hearing from you by no later than October 
     16, 2008. All documents responsive to this request should be 
     sent electronically in PDF format to Brian_Downey@finance-
rep.senate.gov. If you have any questions, please do not 
     hesitate to contact Paul Thacker at (202) 224-4515.
           Sincerely,
                                              Charles E. Grassley,
                                                   Ranking Member.
       Attachment.

          DR. CHARLES NEMEROFF'S DISCLOSURES ON GLAXOSMITHKLINE
------------------------------------------------------------------------
                                                                Amount
     Year             Company          Disclosure filed in     company
                                            March 2008         reported
------------------------------------------------------------------------
2000.........  GlaxoSmithKline......  No amount provided        $190,918
                                       \1\.
2001.........  GlaxoSmithKline......  No amount provided         135,460
                                       \1\.
2002.........  GlaxoSmithKline......  $15,000..............      232,248
2003.........  GlaxoSmithKline......  Not reported.........      119,756
2004.........  GlaxoSmithKline......  $9,999...............      171,031
2005.........  GlaxoSmithKline......  $9,999...............       78,097
2006.........  GlaxoSmithKline......  No amount provided         32,978
                                       \2\.
------------------------------------------------------------------------
\1\ Consulting agreement for two weekends a year.
\2\ Speaker's Bureau, $3,500 per talk; $5,250 for rotating speakers
  series.
Note 1: When a Physician named a company in a disclosure but did not
  provide an amount, the text reads ``no amount reported.'' When a
  Physician did not list the company in the disclosure, the column read
  ``not reported.''

  

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