[Congressional Record (Bound Edition), Volume 154 (2008), Part 13]
[Senate]
[Pages 18101-18105]
[From the U.S. Government Publishing Office, www.gpo.gov]




                         PAYMENTS TO PHYSICIANS

  Mr. GRASSLEY. Mr. President, several years ago I started looking at 
the financial relationships between physicians and drug companies. I 
first began these inquiries by examining payments from pharmaceutical 
companies to physicians serving on Food and Drug Administration 
advisory boards. More recently, I began looking at professors at 
medical schools and their financial relationships with pharmaceutical 
companies. In turn, I scrutinized the grants that these physicians may 
have received from the National Institutes of Health.
  I first examined a psychiatrist at the University of Cincinnati. Then 
I looked at three research psychiatrists who took millions of dollars 
from the drug companies and failed to fully report their financial 
relationships to Harvard and Mass General Hospital.
  I then discovered a doctor at Stanford who founded a company that is 
seeking the Food and Drug Administration's approval to market a drug 
for psychotic depression. The National Institutes of Health is funding 
some of the research on this drug, which is being led by this same 
Stanford scientist. If his own research finds that the drug is 
successful, this researcher stands to gain millions. The NIH later 
removed this researcher from the grant.
  I would now like to address two doctors with the University of Texas 
System.
  Dr. Augustus John Rush is a psychiatrist at the University of Texas 
Southwestern Medical Center. During 2003-2005, Dr. Rush received an NIH 
grant to conduct a clinical training program. This program helped 
trainees understand how to conduct proper clinical trials and also 
dealt with medical ethics.
  However, just 2 years before getting this Federal grant, Dr. Rush 
failed to report all of the money that Eli Lilly paid him. Dr. Rush 
disclosed $3,000 in payments from the company, but Eli Lilly tells me 
that they paid Dr. Rush $17,802 in 2001.
  I would also like to discuss Dr. Karen Wagner, a professor at the 
University of Texas Medical Branch at Galveston.
  Dr. Wagner was one of the authors on a Paxil study known as Study 
329. This study was published in 2001.
  Study 329 was cited in a New York case where GlaxoSmithKline was 
charged with ``repeated and persistent fraud.'' Part of the case 
against Glaxo was that the drug company promoted positive findings but 
didn't publicize unfavorable data.
  In March 2006, Dr. Wagner was being deposed in a case on Paxil. 
During that deposition, Dr. Wagner was asked how much money she had 
taken from drug companies over the previous 5 years.
  Her response? She said: ``I don't know.'' In fact, she testified that 
she couldn't even estimate how much money she received from the drug 
companies.
  According to Glaxo, they paid Dr. Wagner over $53,220 in 2000. In 
2001, when study 329 was published the company reported paying her 
$18,255.
  During many of these years, Dr. Wagner has led NIH-funded studies on 
depression. These studies involved Paxil and Prozac; an antidepressant 
made by Eli Lilly. Eli Lilly reported to me that they paid Dr. Wagner 
over $11,000 in 2002. However, Dr. Wagner did not disclose this payment 
to the University of Texas.
  Apparently, the University of Texas Medical Branch didn't require 
their physicians to disclose their financial relationships with the 
drug industry, until around 2002. But federal guidelines from 1995 are 
clear that researchers need to disclose this money when they take a 
grant from the NIH.
  What makes this even more interesting is that from September 2003 
through August 2004, Dr. Wagner was a voting member of the Conflict of 
Interest Committee at her university. That is right, she was one of the 
university's experts on conflicts of interest during the same time that 
she was not reporting her outside income.
  Before closing, I would like to say that the University of Texas 
System has been very cooperative in this investigation. And I 
appreciate the continued cooperation of companies like GlaxoSmithKline 
and Eli Lilly.
  I ask unanimous consent to have my letter to the University of Texas 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:
                                                      U.S. Senate,


                                         Committee on Finance,

                                Washington, DC, September 9, 2008.
     Mark G. Yudof,
     Chancellor, The University of Texas System, Austin, TX. 
         78701.
       Dear Mr. Yudof: 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 health care 
     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 
     recognized experts, like those at the University of Texas 
     (University/Texas System) system's medical schools who are 
     discussed throughout this letter, often have a profound 
     impact upon the decisions made by taxpayer funded programs 
     like Medicare and Medicaid and the way that patients are 
     treated and funds expended.
       Moreover, and as has been detailed in several studies and 
     news reports, funding by pharmaceutical companies can 
     influence scientific studies, continuing medical education, 
     and the prescribing patterns of doctors. Because I am 
     concerned that there has been little transparency on this 
     matter, I have sent letters to almost two dozen research 
     universities across the United States.

[[Page 18102]]

     In these letters, I asked questions about the conflict of 
     interest disclosure forms signed by some of their faculty. 
     Universities require doctors to report their related outside 
     income, but I am concerned that these requirements are 
     sometimes disregarded.
       I have also been taking a keen interest in the almost $24 
     billion annually appropriated to the National Institutes of 
     Health (NIH) to fund grants at various institutions such as 
     yours. As you know, institutions are required to manage a 
     grantee's conflicts of interest. But I am learning that this 
     task is made difficult because physicians do not consistently 
     report all the payments received from drug and device 
     companies.
       To bring some greater transparency to this issue, Senator 
     Kohl and I introduced the Physician Payments Sunshine Act 
     (Act). This Act will require drug and device companies to 
     report publicly any payments that they make to doctors, 
     within certain parameters.
       I am writing to assess the implementation of financial 
     disclosure policies of the University of Texas system. In 
     response to my letters of October 26, 2007, your University 
     provided me with the financial disclosure reports that Dr. 
     Augustus John Rush, Jr., at the University of Texas 
     Southwestern Medical Center at Dallas (UTSW) and Dr. Karen 
     Wagner at the University of Texas Medical Branch at Galveston 
     (UTMB) filed during the period of January 2000 through June 
     2007. (the Physicians)
       My staff investigators carefully reviewed each of the 
     Physicians' disclosure forms and detailed the payments 
     disclosed. I then asked that the University confirm the 
     accuracy of the information. In February 2008 your counsel 
     provided clarification and additional information from the 
     Physicians pursuant to my inquiry.
       In addition, I contacted executives at several major 
     pharmaceutical companies and device manufacturers (the 
     Companies) and asked them to list the payments that they made 
     to Drs. Wagner and Rush during the years 2000 through 2007. 
     These Companies voluntarily and cooperatively reported 
     additional payments that the Physicians do not appear to have 
     disclosed to the University.
       Because these disclosures do not match, I am attaching a 
     chart intended to provide a few examples of the data reported 
     to me. This chart contains columns showing the payments 
     disclosed in the forms the Physicians filed with the 
     University and amounts reported by some of the Companies.
       I understand that UTMB did not require that dollar amounts 
     be reported in financial disclosures until 2002, despite 
     federal requirements which required such reporting for NIH 
     grantees in 1995. I also understand that UTSW's disclosures 
     do not disclose if payments were made during a calendar year 
     or an academic year.
       I would appreciate further information to see if the 
     problems I have found with these two Physicians are systemic 
     within the University System.


                     INSTITUTIONAL AND NIH POLICIES

       The Texas System requires that all compensation (income or 
     monetary value given in return for services) be reported. Its 
     policies consider compensation in the aggregate that meet or 
     exceeded $10,000 for the current calendar year, or are 
     expected to meet or exceed that amount in the next 12 months, 
     to be a significant financial interest.
       Further, federal regulations place several requirements on 
     a university/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 5 percent ownership in a single entity.
       Based upon information available to me, it appears that 
     each of the Physicians identified above received NIH grants 
     to conduct studies. During the years 2003-2005, Dr. Rush 
     received an NIH grant to conduct a clinical intervention 
     training program that was to provide trainees with, among 
     other things, ``. . . knowledge and experience in the proper 
     conduct of clinical intervention research, ethics, human 
     subjects issues . . .'' However, my inquiry discovered that 
     Dr. Rush did not disclose all of the drug and device industry 
     payments to the University. For example, in 2001, Dr. Rush 
     disclosed $3,000 in outside income for his work as an 
     Advisory Board member for the Eli Lilly Company (Lilly). In 
     contrast, Lilly reported to me that it paid Dr. Rush $17,802 
     for advisory services that year.
       For calendar years 2000 through 2008, Dr. Wagner led NIH-
     funded studies on depression. These studies involved drugs 
     produced by Lilly (Prozac) and GlaxoSmithKline (GSK) (Paxil). 
     Lilly reported to me that it paid Dr. Wagner over $11,000 in 
     2002. However, and based upon the information in my 
     possession, Dr. Wagner did not disclose this payment to the 
     University in 2002 the first year that UTMB required 
     financial disclosures from its faculty.
       It seems that Dr. Wagner also did not report payments she 
     received from GSK. GSK reported paying Dr. Wagner $53,220 in 
     2000--the first year of the NIH grant. Further, GSK reported 
     paying her $18,255 in 2001, and $34,961 in 2002 and $31,799 
     in 2003. Between the years of 2000 through 2005, GSK reported 
     paying Dr. Wagner $160,404. The only report Dr. Wagner made 
     of these payments was in 2005 when she reported $600 from 
     GSK.
       In light of the information set forth above, I ask your 
     continued cooperation in examining conflicts of interest. In 
     my opinion, institutions across the United States must be 
     able to rely on the representations of its faculty to ensure 
     the integrity of medicine, academia, and the grant-making 
     process. At the same time, should the Physician Payments 
     Sunshine Act become law, institutions like yours will be able 
     to access a database that will set forth the payments made to 
     all doctors, including your faculty members.
       Accordingly, I request that your respective institutions 
     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 of the NIH grants received by the Physicians, 
     please confirm that the Physicians reported to the University 
     of Texas System's designated official ``the existence of [a] 
     conflicting interest.'' Please provide separate responses for 
     each grant received for the period from January 1, 2000 to 
     the present, and provide any supporting documentation for 
     each grant identified.
       (2) For each grant identified above, please explain how the 
     University ensured ``that the interest has been managed, 
     reduced, or eliminated.'' Please provide an individual 
     response for each grant that each of the Physicians received 
     from January 2000 to the present, and provide any 
     documentation to support each claim.
       (3) Please report on the status of the University's review 
     of the discrepancies in the financial disclosures made by 
     Drs. Rush and Wagner to the University, including what 
     action, if any, will be considered.
       (4) For Drs. Rush and Wagner, please report whether a 
     determination can be made as to whether or not there is/was a 
     violation of the guidelines governing clinical trials and the 
     need to report conflicts of interest to an institutional 
     review board (IRB). Please respond by naming each clinical 
     trial for which the doctor was the principal investigator, 
     along with confirmation that conflicts of interest were 
     reported, if possible.
       (5) Please provide a total dollar figure for all NIH monies 
     received annually by the Texas System. This request covers 
     the period of 2000 through 2007.
       (6) Please provide a list of all NIH grants received by the 
     University of Texas System. This request covers the period of 
     2000 through 2007. For each grant please provide the 
     following:
       a. Primary Investigator;
       b. Grant Title;
       c. Grant number;
       d. Brief description; and
       e. Amount of Award.
       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 
     September 23, 2008. All documents responsive to this request 
     should be sent electronically in PDF format to 
     Brian_D[email protected]. If you have any 
     questions, please do not hesitate to contact Paul Thacker 
     (202) 224-4515.
           Sincerely,
                                              Charles E. Grassley,
                                                   Ranking Member.
       Attachment.

    SELECTED DISCLOSURES BY DR. RUSH AND RELATED INFORMATION REPORTED BY PHARMACEUTICAL COMPANIES AND DEVICE
                                                  MANUFACTURERS
----------------------------------------------------------------------------------------------------------------
                                                                 Disclosure filed with
                 Year                          Company                institution        Amount company reported
----------------------------------------------------------------------------------------------------------------
2000.................................  Bristol-Myers Squibb...  $4,000.................                   $2,576
                                       Eli Lilly..............  Not reported...........                    7,718
                                       Merck..................  23,800.................                      n/a
                                       Pfizer.................  No amount provided.....                    1,000
2001.................................  Bristol-Myers Squibb...  Not reported...........                    2,921
                                       Eli Lilly..............  3,000..................                   17,802
                                       Merck \1\..............  30,000.................                      n/a
                                       Merck \2\..............  30,600.................                      n/a
2002.................................  Bristol-Myers Squibb...  No amount provided.....                    5,000
                                       Eli Lilly..............  3,000..................                    4,500

[[Page 18103]]

 
                                       Merck..................  70,000.................                      n/a
                                       Pfizer.................  No amount provided.....                    7,500
2003.................................  Bristol-Myers Squibb...  No amount provided.....                      250
                                       Cyberonics.............  25,000.................                   75,000
                                       Eli Lilly..............  3,000..................                        0
                                       Merck..................  40,000.................                      n/a
2004.................................  Bristol-Myers Squibb...  250....................                      750
                                       Cyberonics.............  56,250.................                   75,000
                                       Eli Lilly..............  2,000..................                    2,000
                                       Forst Pharmaceuticals..  5,000..................                      n/a
                                       Telesessions (Forest     18,000.................                      n/a
                                        Labs).
2005.................................  Cyberonics.............  \3\ 25,200.............               62,000 \5\
                                       Eli Lilly..............  2,000..................                        0
                                       Merck \4\..............  14,000.................                      n/a
                                       Telesessions (Forest     \6\ 15,000.............                      n/a
                                        Labs).
2006.................................  Cyberonics.............  10,000.................              \5\ 100,000
                                       Telesessions (Forest     \7\ 25,000.............                      n/a
                                        Labs).
2007.................................  Pfizer.................  2,000..................                    2,000
----------------------------------------------------------------------------------------------------------------
\1\ Dr. Rush reported on 7/11/01 statement of financial interests for serving as advisory board member.
\2\ Dr. Rush reported in a request for prior approval of outside employment for services as consultant to U.S.
  Strategic Advisory Board for Substance P Antagonists.
\3\ Dr. Rush reported in a request for prior approval of outside employment for $600 per hour (October 1, 2005
  to October 1, 2007) for a maximum of 42 hours each calendar quarter. Payment for services as Chair of
  Depression Scientific Advisory Board and Consultant on issues related to clinical studies involving the use of
  vagus nerve stimulation therapy.
\4\ Dr. Rush reported in a request for prior approval of outside employment for $3,500 per day (January 1, 2005
  to December 31, 2006) for 4 days per year plus teleconferences. Payment for services as Insomnia Advisory
  Board Member.
\5\ Payments reported by Cyberonics for consultation services performed during the year shown, although some of
  the checks were issued in a different year.
\6\ Dr. Rush reported in a request for prior approval of outside employment for $1,000 per call (15 hours per
  year). Payment for services as faculty speaker on a series of conference calls as an educational service to
  physicians.
\7\ Dr. Rush reported in a request for prior approval of outside employment for $1,000 per call (25 calls about
  50 minutes each). Payment for services as faculty speaker on a series of conference calls as an educational
  service to physicians.
 
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 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 estimated that the payments Dr. Rush disclosed totaled about $600,000 during the period
  January 2000 through June 2007. Information reported by the pharmaceutical companies indicate that they made
  additional payments that are not reflected in his disclosures.


   SELECTED DISCLOSURES BY DR. WAGNER AND RELATED INFORMATION REPORTED BY PHARMACEUTICAL COMPANIES AND DEVICE
                                                  MANUFACTURERS
----------------------------------------------------------------------------------------------------------------
                                                                 Disclosure filed with
                 Year                          Company                institution        Amount company reported
----------------------------------------------------------------------------------------------------------------
2000 \1\.............................  GlaxoSmithKline........  Not reported...........              \2\ $53,220
                                       Pfizer.................  Not reported...........                    5,000
2001 \1\.............................  Bristol-Myers Squibb...  Not reported...........                    4,194
                                       GlaxoSmithKline........  Not reported...........               \3\ 18,255
                                       Pfizer.................  Not reported...........                    3,000
2002.................................  Eli Lilly..............  Not reported...........                   11,000
                                       GlaxoSmithKline........  Not reported...........                   34,961
                                       Pfizer.................  Not reported...........                    2,500
2003.................................  Eli Lilly..............  Not reported...........                    9,750
                                       GlaxoSmithKline........  Not reported...........                   31,799
                                       Pfizer.................  Not reported...........                    6,350
2004.................................  AstraZeneca............  Not reported...........                    2,100
                                       Eli Lilly..............  Not reported...........                    8,632
                                       GlaxoSmithKline........  Not reported...........                   17,371
                                       Pfizer.................  Not reported...........                    1,000
2005.................................  AstraZeneca............  2,100..................                        0
                                       Abbott Labs............  14,000.................                      n/a
                                       Eli Lilly..............  Not reported...........                      300
                                       Pfizer.................  3,500..................                    6,000
                                       GlaxoSmithKline........  600....................                \4\ 4,796
2006.................................  Abbott Labs............  10,000.................                      n/a
                                       Bristol-Myers Squibb...  5,400..................                    7,204
                                       Eli Lilly..............  4,531..................                    4,531
2007.................................  Bristol-Myers Squibb...  1,500..................                    1,500
                                       Eli Lilly..............  3,281..................                    3,281
----------------------------------------------------------------------------------------------------------------
\1\ ``The University of Texas Medical Branch at Galveston's conflict of interest policy did not provide for
  annual disclosures until 2002.
\2\ Payments for 19 talks on Paxil.
\3\ Payments for 7 talks on Paxil.
\4\ Honorarium and Expense. Paxil Psychiatry Advisory Board Member. Waldorf Astoria, 301 Park Ave., New York,
  NY. February 17, 2005.
 
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 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 estimated the payments Dr. Wagner disclosed totaled about $100,000 during the period
  January 2000 through June 2007. Information reported by the pharmaceutical companies indicate that they made
  additional payments that are not reflected in her disclosures.


[[Page 18104]]

[GRAPHIC] [TIFF OMITTED] TS09SE08.001


[[Page 18105]]



                          ____________________