This time, the ranking Republican on the US Senate Finance Committee is fingering Karen Wagner, a researcher at the University of Texas who worked on a National Institutes of Health study involving Glaxo’s Paxil antidepressant, who allegedly did not disclose more than $150,000 in consulting and speaking fees she received from the drugmaker, according to The Wall Street Journal.

Grassley cited Wagner after comparing records from Glaxo and the university. Between 2000 and 2008, she was involved in an NIH study on the use of Paxil to treat teenage depression and another study on teen anxiety, the paper writes. The university’s legal counsel tells the paper they will look for any discrepancies in Wagner’s disclosure reports, Wagner did not respond to the paper’s requests for comment. The University of Texas has received more than $5 billion from NIH since 2000. Read Grassley’s letter to the university.

Wagner was considered one of Glaxo’s “opinion leaders,” speaking at many medical meetings about Paxil, according to documents from civil lawsuits, the paper writes. Paxil has been linked to teenage suicide and suicidal behavior, although Glaxo maintains the drug is safe. Wagner was a co-author of the Brown study on Paxil that has come under attack for allegedly overstating the drug’s safety (background).

In 2000, the first year of the NIH grant, Wagner, who is based at the University of Texas Medical Branch in Galveston, received $53,000 from Glaxo, which included a trip to Paris to speak at a company meeting, Glaxo confirmed. Interesting irony: From 2003 to 2004, while receiving additional funds from Glaxo, she served on the university committee policing conflict of interest.

Grassley, you may recall, has similarly criticized other academics at Harvard University, Brown University, Stanford University and the University of Cincinnati, among roughly two dozen universities around the country whose researchers receive NIH funding as part of an effort to disclose ties between academia and the pharmaceutical industry.

The NIH director, Elias Zerhouni, met Tuesday with Senate Finance staff, the paper writes, amid calls by Grassley for the NIH to yank grants to universities that fail to report their researchers’ outside income from drug firms, as required by law. Last month, Stanford reassigned named a different principal investigator for a grant awarded to Alan Schatzberg, who chairs its psychiatry department.

The NIH gave more than $23 billion last year to educational institutions, the paper notes, and Zerhouni has been publicly skeptical about NIH’s ability to pull grants. But Grassley appears adamant: “Starting today, the NIH could send a signal that business as usual is over…The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure.”

Last month, Stanford announced a policy to restrict drug-company funding of continuing medical-education programs. Harvard has said that it is reviewing its conflict-of-interest policies.

“Universities have been treading on dangerous ground with their increasingly complex financial ties to industry,” Jerome Kassirer, former editor of The New England Journal of Medicine, tells the Journal. “They are worried that these things could ultimately affect their tax-free status.” Many faculty members remain on company speakers’ bureaus, he notes.

Barry Burgdorf, the university’s vice chancellor for legal affairs tells us there doesn’t appear to be a major problem with the 15-branch university’s disclosure system. “Any disclosure system must rely on disclosure of the people you’re for disclosure…It doesn’t mean you don’t have good system in place…We have 18,000 faculty…If we have one doctor who fails to disclose something, that would say nothing about our ability to manage disclosure or conflicts…In my opinion, wew have a very robust policy in place.” He adds there is no action planned to review university policies.

September 9, 2008

Via Electronic Transmission

Mark G. Yudof
Chancellor
The University of Texas System
201 West Seventh Street
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. 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.[1] 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.[2] 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”[3] 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…”[4] 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). [5] 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_Downey@finance-rep.senate.gov. If you have any questions, please do not hesitate to contact Paul Thacker (202) 224-4515.

Sincerely,

Charles E. Grassley
Ranking Member