The US Senate Finance Committee is investigating not one, but two academics from the University of Texas for failing to disclose payments from drugmakers at the same time they conducted research funded by the National Institutes of Health. Earlier, we wroteKaren Wagner is being targeted, and so is John Rush, the former head of the controversial TMAP program.
As part of his probe into ties between academia and pharma, Chuck Grassley, the committee's ranking Republican, has zeroed in on conflicts of interest. Universities are supposed to monitor conflicts when their researchers receive NIH grants, and the NIH is supposed to monitor conflicts, at least involving payments exceeding $10,000 over a 12-month period.
As reported previously (see this post), academics at Harvard University, Stanford University, the University of Cincinnati and Brown University are being investigated as Grassley pressures the NIH to revoke grants when conflicts are found. Some 20 schools and the American Psychiatric Association are also being probed.
In a speech on the Senate floor, Grassley said: "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 two 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." The chart indicates further discrepancies (please click to enlarge). We have asked the University of Texas for comment.
Why is TMAP controversial? The state filed a lawsuit against Johnson & Johnson’s Jannsen unit for allegedly using false advertising and improper influence - such as grants, trips and other perks - to get its Risperdal antipsychotic on the now-mandatory adult protocol, the Texas Medication Algorithm Project. Drugmakers also reportedly paid decision makers to promote their meds. Rush, by the way, last month joined the Duke-NUS Graduate Medical School Singapore as vice dean for clinical sciences.
UPDATE:The university's counsel, Barry Burgdorf, called to say: "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.
Statement of Senator Charles E. Grassley Before the United States Senate Payments to Physicians September 9, 2008
SPEECH ON 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 two 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 five years.
Her response? She said, and I quote, “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’s 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 would like to enter my letter to the University of Texas into the record.
I yield the floor.