[Congressional Record (Bound Edition), Volume 154 (2008), Part 13]
[Senate]
[Pages 17671-17674]
[From the U.S. 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 my latest letters to Stanford University 
and to the National Institutes of Health printed in the Record.
  I yield the floor.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:
                                                      U.S. Senate,


                                         Committee on Finance,

                                    Washington, DC, July 30, 2008.
     Dr. John L. Hennessy,
     President, Stanford University, Office of the President, 
         Stanford, CA.
       Dear Dr. Hennessy: First, I would like to thank you for 
     your prompt attention to the matter involving payments made 
     by pharmaceutical companies to Dr. Alan Schatzberg, Chairman 
     of the Department of Psychiatry at Stanford University 
     (Stanford/University). Investigators with the Senate Finance 
     Committee (Committee) believe that the following chart 
     provides a better representation of Dr. Schatzberg's 
     disclosures to Stanford and company reports to the Committee.
       Committee investigators understand that differences in 
     reporting requirements and accounting methods may result in 
     differences between Dr. Schatzberg's reports and reports from 
     companies that can only be explained in writing. The 
     Committee understands that Stanford will provide a 
     comprehensive response to the initial letter sometime soon, 
     which will include these details. Stanford has notified the 
     Committee that any discrepancies in the chart are most likely 
     due to differences in accounting between Stanford and the 
     various companies contacted by the Committee.
       As Stanford pointed out in a public statement, there was an 
     error in the chart that the Committee sent to you regarding 
     payments from Eli Lilly to Dr. Schatzberg in 2007. That chart 
     stated that Dr. Schatzberg had ``not reported'' this money 
     when in fact he had. Therefore, this letter is being placed 
     in the congressional record to correct the official record.
       Stanford also noted that Dr. Schatzberg's reports on 
     payments from Eli Lilly in 2004 include compensation of less 
     than $10,000 for advisory board activities and $10,000 to 
     $50,000 for honoraria for papers, lectures and consulting. 
     This also matches the footnote in the Committee's chart and 
     appears to capture all the monies reported by Eli Lilly 
     ($52,134) for that year.
       However, Committee investigators still have concerns 
     regarding Johnson & Johnson's report of paying Dr. Schatzberg 
     $22,000

[[Page 17672]]

     in 2002. According to Stanford's statement, ``Dr. Schatzberg 
     did disclose this payment to the university and also reported 
     it to the Committee. He disclosed the $22,000 payment from 
     Jannsen, the wholly-owned subsidiary of Johnson & Johnson 
     that made the payment.'' The reason that we continue to be 
     concerned is because Dr. Schatzberg reported less than 
     $10,000 from Jannsen for academic year 2002 (September 2, 
     2001 through August 31, 2002) and less than $10,000 for 
     academic year 2003 (September 1, 2002 through August 31, 
     2003). Johnson & Johnson did not delineate payments from 
     subsidiaries such as Jannsen when it reported the information 
     to the Committee. Johnson & Johnson reported a payment of 
     ``fee for services'' of $22,000 to Dr. Schatzberg on August 
     19, 2002. Even noting differences in accounting methods, Dr. 
     Schatzberg's reports on Jannsen do not appear to fully 
     explain the discrepancy.
       Inconsistencies also appear among the payments reported to 
     us by Eli Lilly in 2002. Eli Lilly reported paying Dr. 
     Schatzberg $19,788 that calendar year. However, Dr. 
     Schatzberg reported that he received less than $10,000 from 
     Eli Lilly for academic year 2002 (September 2, 2001 through 
     August 31, 2002) and more than $10,000 for academic year 2003 
     (September 1, 2002 through August 31, 2003). Noting possible 
     differences in accounting methods, Dr. Schatzberg's reports 
     on Eli Lilly may explain the discrepancy, but only if one 
     combined the 2002 and 2003 academic years.
       Further, based on documents in our possession, it appears 
     that Wyeth paid Dr. Schatzberg for testifying as an expert 
     witness in 2006. This work was in response to lawsuits 
     brought against Wyeth regarding its antidepressant, Effexor. 
     As Dr. Schatzberg wrote in an undated expert report on behalf 
     of Wyeth, ``My hourly rate for review of materials or for 
     testimony is $500.'' Dr. Schatzberg was apparently an expert 
     witness in at least two cases for Wyeth, but payments for 
     this work cannot be found in his reports of outside income to 
     Stanford. Therefore, I would appreciate your clarification of 
     Dr. Schatzberg's expert witness fees and how they are 
     recorded on Stanford's financial disclosure forms.
       Thank you again for your continued cooperation and 
     assistance in this matter. I look forward to a complete 
     response to outstanding questions in the near future. If you 
     have any questions, please do not hesitate to contact Paul 
     Thacker at (202) 224-4515.
           Sincerely,
                                              Charles E. Grassley,
                                                   Ranking Member.
       Attachment.

 SELECTED DISCLOSURES BY DR. SCHATZBERG AND RELATED INFORMATION REPORTED
          BY PHARMACEUTICAL COMPANIES AND DEVICE MANUFACTURERS
------------------------------------------------------------------------
                                                                Amount
                                         Disclosure filed      company
     Year              Company           with institution      reported
                                          (academic year)     (calendar
                                                                year)
------------------------------------------------------------------------
2000            Bristol Myers Squibb.  No amount provided..       $1,000
                Eli Lilly............  No amount provided..      $10,070
2001            Bristol Myers Squibb.  No amount provided..       $4,147
                Corcept Therapeutics.  >$10,000<$50,000 \1\          n/a
                Eli Lilly............  <$10,000 \2\........      $10,788
2002            Bristol-Myers Squibb.  No amount provided..       $2,134
                Corcept Therapeutics.  >$100,000 \3\.......          n/a
                Corcept Therapeutics.  <$10,000 \1\........          n/a
                Corcept Therapeutics.  <$10,000 \4\........          n/a
                Eli Lilly............  <$10,000............      $19,788
                Johnson & Johnson      <$20,000 \5\........      $22,000
                 (Jannsen).
2003
                Bristol-Myers Squibb.  No amount provided..       $4,000
  Corcept       <$10,000 \4\.........  n/a.................
 Therapeutics
                Corcept Therapeutics.  >$10,000<$50,000 \1\          n/a
                Corcept Therapeutics.  >$100,000 \3\.......          n/a
                Eli Lilly............  >$10,000............      $18,157
2004            Bristol-Myers Squibb.  <$10,000............           $0
                Corcept Therapeutics.  >$10,000<$50,000 \1\          n/a
                Corcept Therapeutics.  $100,000 \3\........          n/a
                Eli Lilly............  <$110,000...........      $52,134
                Pfizer...............  Not reported........       $2,500
------------------------------------------------------------------------
                       Reporting by Calendar Year
------------------------------------------------------------------------
2005            Bristol-Myers Squibb.  <$10,000............           $0
                Corcept Therapeutics.  >$10,000<$50,000 \1\          n/a
                Corcept Therapeutics.  >$100,000 \3\.......          n/a
                Eli Lilly............  >$10,000<$50,000....       $9,500
                Pfizer...............  No amount provided..       $2,000
2006            Bristol-Myers Squibb.  Not reported........   \6\ $6,000
                Corcept Therapeutics.  <$10,000 \4\........          n/a
                Corcept Therapeutics.  >$10,000<$50,000 \1\          n/a
                Corcept Therapeutics.  >$100,000 \3\.......          n/a
                Eli Lilly............  >$10,000<$50,000....      $20,500
                Pfizer...............  Not reported........         $300
2007            Eli Lilly............  <$60,000............      $10,063
------------------------------------------------------------------------
\1\ Physician disclosed payment for a variety services including
  Advisory Board Membership, Board of Directors, and consulting.
\2\ Physician disclosed <$10,000 for academic year 2001. No amount
  provided for prior academic year.
\3\ Physician disclosed equity value.
\4\ Physician disclosed payment for royalties from Stanford's licensing
  agreement with Corcept Therapeutics.
\5\ This sum combines two academic years.
\6\ Bristol-Myers Squibb stated that Stanford intended to pay Dr.
  Schatzberg $6,000 for conducting an annual course for which the
  company provides a grant.
 
Note 1: When a Physician named a company in a disclosure but did not
  provide an amount, the text reads ``no amount reported.'' Stanford has
  noted that amounts were not required in each specific case. When a
  Physician did not list the company in the disclosure, the column reads
  ``not reported.'' The Committee contacted several companies for
  payment information and the notation n/a (not available) reflects that
  a company was not contacted.
Note 2: The Committee was not able to estimate the total amount of
  payments disclosed by Dr. Schatzberg during the period January 2000
  through June 2007 due to the fact that some amounts were not provided
  and in other instances ranges were used. Information reported by the
  pharmaceutical companies indicate that their reports do not match Dr.
  Schatzberg's disclosures.

  
                                  ____
                                                      U.S. Senate,


                                         Committee on Finance,

                                    Washington, DC, July 31, 2008.
     Dr. John L. Hennessy,
     President, Stanford University, Office of the President, 
         Stanford, CA.
       Dear Dr. Hennessy: The Senate Finance Committee (Committee) 
     recently sent you a letter attempting to clarify 
     discrepancies in a chart comparing reports of payments made 
     by several pharmaceutical companies against disclosures of 
     outside income filed by Dr. Alan Schatzberg, a psychiatrist 
     at Stanford (Stanford/University). As Committee investigators 
     explained to Stanford officials, we have further questions 
     regarding Dr. Schatzberg's grants from the National 
     Institutes of Health and his relationship with Corcept 
     Therapeutics (Corcept/Company). Corcept was founded in part 
     by Dr. Schatzberg, who has several million dollars of equity 
     in that company.
       In addition, I am interested in understanding Stanford's 
     involvement with Dr. Schatzberg and Corcept. Dr. Schatzberg 
     received grants from the National Institutes of Health (NIH) 
     to study mifepristone and major depression. At the same time, 
     Dr. Schatzberg received compensation from Corcept and had a 
     large equity interest in the Company. This equity could grow 
     dramatically if the results of Dr. Schatzberg's government 
     sponsored research find that mifepristone could be used to 
     treat psychotic major depression.
       I have come to understand, based on documents provided to 
     me by Stanford, that your institution had and may still have 
     a financial relationship with Corcept. This agreement has 
     resulted in Stanford paying Dr. Schatzberg royalties. For 
     instance, Dr. Schatzberg reported in his Stanford disclosures 
     that he received payments of less than $10,000 for royalties 
     from Stanford's licensing agreement with Corcept 
     Therapeutics. These payments were made in 2002, 2003, and 
     2006.
       As is well established, the NIH relies on universities to 
     manage the conflicts that exist between a grantee and any 
     outside financial interests. However, not only does Dr. 
     Schatzberg have a financial interest in Corcept, but Stanford 
     also had a relationship with Corcept and may still at this 
     time. These facts raise multiple questions and concerns. For 
     example, how can Stanford manage Dr. Schatzberg's conflicts 
     of interest with Corcept, when Stanford apparently has a 
     similar conflict of interest? Furthermore, when did Stanford 
     notify the NIH of this conflict?
       Additionally, I have many questions and concerns about 
     Stanford's recent press statement regarding how it managed 
     Dr. Schatzberg's conflicts of interest with Corcept. In that 
     statement, Stanford claimed that steps to manage this 
     conflict ``included his not participating in any human 
     subjects research involving mifepristone. . . .'' However, 
     based upon a search of published literature, Dr. Schatzberg's 
     name appears as the author of several published studies 
     involving human subjects research and mifepristone. Most of 
     these studies were funded by NIH although one study was 
     funded by Corcept and another one was funded by both the NIH 
     and Corcept. These studies include:
       2002--Dr. Schatzberg was the final author on a paper in 
     Biological Psychiatry that reported on a trial to study 
     mifepristone to treat psychotic major depression in 30 
     patients. The study listed support by Corcept along with two 
     grants from the National Institute of Mental Health (MH50604 
     and T-32MH19983), which is one of the NIH's institutes. Dr. 
     Schatzberg is the primary investigator for grant MH50604.
       2006--Dr. Schatzberg published a study involving human 
     subjects treated with mifepristone for psychotic major 
     depression. This study was supported by several NIH grants. 
     Dr. Schatzberg is the primary investigator for three of these 
     grants (R01 MH50604, R01 MH47573, T32 MH019938). In the 
     acknowledgements section of the paper, Dr. Schatzberg 
     disclosed that he had a financial interest in Corcept which 
     has a licensing agreement for mifepristone. Dr. Schatzberg 
     also disclosed that he ``played no direct role in the 
     recruitment, assessment, or follow-up of subjects enrolled in 
     this study,'' and ``was not directly involved in the analysis 
     of data stemming from this research.'' (emphasis added)
       I am not in a position to interpret the disclosures and 
     apparent recusals from research involvement made by Dr. 
     Schatzberg in the 2006 study, however, I am seeking guidance 
     from Stanford regarding its duties to ``manage'' conflicts in 
     light of a possible contradiction. According to the ``NIH 
     Grants Policy Statement,'' the primary investigator of an NIH 
     grant is ``responsible for the scientific or technical 
     aspects of the grant and for day-to-day management of the 
     project or program.'' So, the question arises: how could Dr. 
     Schatzberg monitor the research funded with his NIH grants if 
     he was not involved closely in the study?
       I also would appreciate your guidance on how Dr. Schatzberg 
     could have been recused from involvement in research when he 
     is listed as the primary investigator for several trials. For 
     instance, Stanford's website has a clinical trials directory, 
     which lists Dr.

[[Page 17673]]

     Schatzberg as a co-investigator for a trial seeking to enroll 
     20 patients in a study using mifepristone to treat patients 
     with psychotic major depression. The anticipated start of the 
     trial was January 1, 2003 and the listed collaborator for the 
     trial is the NIH.
       Dr. Schatzberg is also listed as the primary investigator 
     on ClinicalTrials.gov for another study that began in 2005 to 
     treat depressed patients with mifepristone. This NIH funded 
     trial is listed as active, but not recruiting patients. The 
     estimated enrollment was 100 patients in this randomized, 
     double-blind, placebo-controlled study. In addition, Dr. 
     Schatzberg is listed on ClinicalTrials.gov as the ``study 
     director'' for a phase III clinical trial to ``evaluate the 
     effectiveness of mifepristone to treat adults with psychotic 
     major depression.'' This trial is also funded by the NIH and 
     is now actively recruiting patients.
       Further, Stanford acknowledges in its press statement that 
     it ``received a small amount of equity in Corcept under a 
     technology license.'' However, Stanford did not explain when 
     this relationship began or ended. And according to Dr. 
     Schatzberg's 2006 study, Stanford's Institutional Review 
     Board (IRB), which is responsible for approving study 
     protocols, approved his research plan. This raises even more 
     questions regarding how Stanford's IRB could remain 
     independent, especially since Stanford had a financial stake 
     in ensuring that the study protocol was approved. I seek your 
     thoughts on this issue as well.
       Finally, last February the Association of American Medical 
     Colleges (AAMC) released guidelines governing conflicts of 
     interest. The AAMC advised that institutions report conflicts 
     of interest ``in any substantive public communication of the 
     research results.'' However, when Stanford issued a press 
     release regarding the results of Dr. Schatzberg's research on 
     mifepristone, the statement did not note if Dr. Schatzberg 
     and/or Stanford had a financial interests in the research 
     findings. Stanford missed another opportunity to disclose 
     financial interests in a story that ran in the Stanford 
     Report which reported on Dr. Schatzberg's mifepristone 
     research.
       I would also like to better understand Stanford's current 
     and past financial relationship with Corcept. Accordingly, 
     please respond to the following questions and requests for 
     information. The time span for this request covers 1995 to 
     the present. For each response, please repeat the enumerated 
     request and follow with the appropriate answer.
       (1) Please explain Stanford's previous and current 
     financial relationship with Corcept Therapeutics. This 
     response should include the date when Stanford first 
     established a relationship with Corcept Therapeutics, the 
     nature of that relationship, and the date when Stanford 
     divested itself of any financial relationship(s) with 
     Corcept. Also, detail any financial transactions between 
     Stanford and Corcept Therapeutics (i.e. has Stanford invested 
     in Corcept or has Corcept paid a licensing fee to Stanford).
       (2) Please provide a list of all patents and licenses held 
     by Dr. Schatzberg. For each patent and/or license, please 
     provide the following:
       (a) Provide a summary of the patent/license.
       (b) When was the patent/license first issued?
       (c) For each patent/license, please list any companies that 
     have a financial interest in the success of that patent/
     license.
       (d) Please provide an accounting of any compensation paid 
     to Dr. Schatzberg for any patent/license, detailed by dollar 
     amount and year.
       (3) Please provide a list of all studies published by Dr. 
     Schatzberg that involve mifepristone or major depression. For 
     each study, please provide the following:
       (a) Please list the grant(s) which funded each study, in 
     whole or in part.
       (b) If an author listed on the study was at Stanford, 
     please list their department, supervisor, and financial 
     support, at that time.
       (4) For each study identified above, please provide the 
     name of each member of the Institutional Review Board (IRB) 
     that approved the study protocol. For each IRB, please 
     provide the following information:
       (a) Please provide minutes of the IRB meeting when that 
     study was discussed.
       (b) Please explain if the IRB considered financial 
     interests of study investigators and/or Stanford in approving 
     the study protocols.
       (c) Please explain if the IRB required reporting of 
     conflicts of interests to human subjects participating in the 
     study.
       (d) Please provide a point of contact for the IRB.
       (5) According to federal regulations, ``prior to the 
     Institution's expenditure of any funds under the award, the 
     Institution will report to the [Public Health Service] 
     Awarding Component the existence of a conflicting interest 
     (but not the nature of the interest or other details) found 
     by the institution and assure that the interest has been 
     managed, reduced or eliminated.'' Please provide the date and 
     supporting documents that show when Stanford determined that 
     Dr. Schatzberg had a conflict of interest regarding his 
     federal funding of mifespristone research.
       (6) Please provide the date and supporting documents that 
     show when Stanford reported this conflict to the NIH.
       (7) Please provide the following information on Corcept:
       (a) When did Dr. Schatzberg create Corcept?
       (b) When did Corcept apply to the FDA for approval of 
     mifepristone to treat psychotic major depression?
       (c) When did Dr. Schatzberg first become vested in the 
     company?
       (8) Please explain how Stanford manages a conflict of 
     interest with NIH funded researchers if Stanford has a 
     financial interest in the outcome of the study.
       (9) According to Stanford's press statement, ``In addition, 
     NIH reviews its data through its Data Safety and Monitoring 
     Board structures.'' Please provide documentation that a Data 
     Safety Monitoring Board (DSMB) at the NIH has been apprised 
     of Dr. Schatzberg's and/or Stanford's financial interests in 
     Corcept.
       (10) The AAMC advises institutions to report conflicts of 
     interest ``in any substantive public communication of the 
     research results.'' Please explain Stanford's policies for 
     reporting conflicts of interest in press releases and other 
     publications controlled by Stanford.
       (11) Dr. Schatzberg has reported in a 2006 publication that 
     he ``played no direct role in the recruitment, assessment, or 
     follow-up of subjects enrolled in this study,'' and ``was not 
     directly involved in the analysis of data stemming from this 
     research.'' Please explain how, with such constraints, Dr. 
     Schatzberg was able to monitor the spending of his NIH 
     grants.
       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 August 
     14, 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.
           Sincerely,
                                              Charles E. Grassley,
     Ranking Member.
                                  ____

                                                      U.S. Senate,


                                         Committee on Finance,

                                    Washington, DC, July 31, 2008.
     Elias A. Zerhouni, M.D.,
     Director, National Institutes of Health,
     Bethesda, MD
       Dear Director Zerhouni: As a senior member of the United 
     States Senate and the Ranking Member of the Committee on 
     Finance (Committee), I have a duty under the Constitution to 
     conduct oversight into the actions of executive branch 
     agencies, including the activities of the National Institutes 
     of Health (NIH/Agency). In this capacity, I must ensure that 
     NIH properly fulfills its mission to advance the public's 
     welfare and makes responsible use of the public funding 
     provided for medical studies. This research often forms the 
     basis for action taken by the Medicare and Medicaid programs.
       I would like to follow up with you on my concerns about the 
     lack of oversight regarding conflicts of interest relating to 
     the almost $24 billion in annual extramural funds that are 
     distributed by the NIH. I appreciate the comments you made 
     recently during the NIH appropriations hearing where you 
     mentioned several times that we need more ``sunshine.'' I 
     could not agree more.
       I recently sent several letters to Stanford University 
     (Stanford/University) regarding Dr. Alan Schatzberg, chair of 
     Stanford's department of psychiatry. I am attaching those 
     letters for your review and consideration.
       According to information found on the NIH's CRISP database 
     of extramural grants, Dr. Schatzberg has/had NIH grants to 
     study mifepristone as well as major depression. At the same 
     time it appears that he has also had an ongoing financial 
     relationship with Corcept Therapeutics (Corcept/Company). 
     Corcept is seeking approval from the Food and Drug 
     Administration for mifepristone to treat psychotic major 
     depression. Corcept was founded (in part) by Dr. Schatzberg 
     and he has several million dollars of equity in the company. 
     Dr. Schatzberg has also received payments over several years 
     from Corcept and has received payments directly from Stanford 
     because of its licensing agreement with Corcept for 
     mifepristone.
       The intertwined relationship between Stanford, Dr. 
     Schatzberg, and Corcept was first reported in 2006 in a two-
     part series that ran in the San Jose Mercury News. In light 
     of this article, I am interested in understanding if the NIH 
     investigated potential conflicts of interest after this 
     series appeared. I would also like to know when Stanford 
     first notified the NIH that Dr. Schatzberg had a conflict of 
     interest regarding his large equity interest in Corcept.
       Stanford's attempts to manage Dr. Schatzberg's conflicts of 
     interest and his NIH grants raise several questions. 
     According to Stanford's recent press statement, this 
     management ``included his not participating in any human 
     subjects research involving mifepristone. . . .'' However, 
     Dr.

[[Page 17674]]

     Schatzberg's name appears as the author of several published 
     studies involving human subjects research and mifepristone. 
     One of these studies was funded by Corcept, some were funded 
     by the NIH, and one was funded by both Corcept and the NIH.
       For instance, in 2006, Dr. Schatzberg published a study 
     involving human subjects treated with mifepristone for 
     psychotic major depression. This study was supported by 
     several NIH grants. In the acknowledgements section of the 
     paper, Dr. Schatzberg disclosed that he had a financial 
     interest in Corcept Therapeutics, which has a licensing 
     agreement for mifepristone. Dr. Schatzberg also disclosed 
     that he ``played no direct role in the recruitment, 
     assessment, or follow-up of subjects enrolled in this 
     study,'' and ``was not directly involved in the analysis of 
     data stemming from this research.'' This disclosure raises 
     some interesting questions regarding Dr. Schatzberg's 
     involvement in the study. Specifically, how could Dr. 
     Schatzberg monitor the research funded with his NIH grants if 
     he was not involved closely in the study?
       Dr. Schatzberg was also a lead investigator in a study on 
     mifepristone for treating psychotic major depression back in 
     2002. This study was supported by a grant from Corcept along 
     with related support from the National Institute of Mental 
     Health (NIMH), one of the NIH's institutes. I am wondering 
     how such grants are provided and how the possible conflict of 
     interests are managed and by whom.
       Furthermore, Dr. Schatzberg is listed as the primary 
     investigator on ClinicalTrials.gov for another study to treat 
     patients with depression with mifepristone, which began in 
     2005. This NIH funded trial is listed as active but is not 
     recruiting patients. The estimated enrollment was for 100 
     patients in this randomized, double-blind, placebo-controlled 
     study. Also, Dr. Schatzberg is listed on ClinicalTrials.gov 
     as the ``study director'' for a phase III clinical trial to 
     ``evaluate the effectiveness of mifepristone to treat adults 
     with psychotic major depression.'' This trial is also funded 
     by the NIH and is now actively recruiting patients.
       According to the ``NIH Grants Policy Statement'' the 
     primary investigator of an NIH grant is ``responsible for the 
     scientific or technical aspects of the grant and for day-to-
     day management of the project or program.'' So the question 
     arises: how could Dr. Schatzberg monitor the research funded 
     with his NIH grants if he was not involved closely in the 
     study?
       I also understand that Stanford had a licensing agreement 
     with Corcept and was paying royalties to Dr. Schatzberg for 
     several years. Again, I am wondering how Stanford could 
     manage Dr. Schatzberg's conflicts when it also has a 
     financial interest in the company and the research outcome.
       I would appreciate a greater understanding of Stanford's 
     role in ``managing'' Dr. Schatzberg's conflicts of interest 
     regarding his NIH grants to study mifepristone. Accordingly, 
     please respond to the following questions and requests for 
     information. The time span of this request covers 1995 to the 
     present. For each response, please repeat the enumerated 
     request and follow with the appropriate answer.
       1. Following the series by the San Jose Mercury News, did 
     the NIH examine Stanford's management of Dr. Schatzberg's 
     conflicts of interest? If yes, please provide me with copies 
     of all pertinent documents and communications. If not, why 
     not?
       2. According to the ``NIH Grants Policy Statement,'' Dr. 
     Schatzberg's role as the primary investigator of his NIH 
     grants is to be ``responsible for the scientific or technical 
     aspects of the grant and for day-to-day management of the 
     project or program.'' How can Dr. Schatzberg live up to these 
     obligations when Stanford's press statement claims that he 
     ``played no direct role in the recruitment, assessment, or 
     follow-up of subjects enrolled in this study,'' and ``was not 
     directly involved in the analysis of data stemming from this 
     research''?
       3. Does the NIH allow researchers to recuse themselves from 
     involvement in the research funded by their own NIH grants? 
     If yes, did the NIH allow Dr. Schatzberg to recuse himself 
     from any of the grants made to him by the NIH?
       4. Please provide a list of all NIH grants received by Dr. 
     Schatzberg. For each grant, please provide the following: a. 
     Name of grant; b. Topic of grant; and c. Amount of funding 
     for grant.
       5. Please provide a list of any other interactions that Dr. 
     Schatzberg has had with the NIH to include membership on 
     advisory boards, peer review on grants, or the like. The span 
     of this request covers 1998 to the present.
       6. Stanford has claimed that Dr. Schatzberg's research has 
     been monitored by an NIH Data Safety Monitoring Board (DSMB). 
     Does the NIH DSMB provide oversight of conflicts of interest 
     for a study? If so, please explain. If not, why not?
       I look forward to hearing from you by no later than August 
     14, 2008. If you have any questions, please contact my 
     Committee staff, Paul Thacker at (202) 224-4515. Any formal 
     correspondence should be sent electronically in PDF 
     searchable format to Brian_D[email protected].
           Sincerely,
                                              Charles E. Grassley,
     Ranking Member.

                          ____________________