Letters from Grassley: Pawns in a Chess Game

Senator Grassley is putting the pressure on the National Institutes of Health to beef up their enforcement of disclosure rules for those working on NIH research grants ($23 billion/year), including pulling funding from one or two grants to set an example to all other institutions receiving grants. According to the Wall Street Journal, the senator’s staff met with the director of NIH, Elias Zerhouni, this past Tuesday to again discuss enforcement of these rules.

Senator Grassley has been quoted as saying: "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."

As part of applying pressure on NIH to beef up their enforcement, the Senator is taking to bi-monthly floor speeches singling out physician researchers who he believes are not following the disclosure rules.

Unfortunately, it isn’t clear that all the facts are collected and verified before he “exposes” yet another researcher in psychiatry. This isn’t a Senate hearing where the researcher has a chance to prepare and respond – this is a surprise attack where you wake up one morning and discover your name in the news, linked to words like “illegal” or “unethical.”

The Senator’s staff has done some simple extrapolating asking pharmaceutical and device companies to report the funds they paid for research, consulting and speaking and comparing that with information that the physicians submitted to their institutions. In some instances the institutions did not require disclosure until recently which explains some of the discrepancies in the data. In some cases the institution’s reporting system asks for ranges, and in other instances the faculty member in all likelihood did not either understand the request and information about this issue by the institutions was weak or even non existent or they did perhaps fail to register but all those instances are unclear.

The two pawns in the Senators chess game with NIH this week include two important Texas psychiatrists Karen Wagner, MD, Ph.D. and John Rush, MD both prominent researchers from Texas.

In the case of 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”.

We pulled the study and it actually has a name (Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial) and Dr. Wagner was the listed 18^th on the author list, which means she was not a writer but rather a study center, and not necessarily involved writing the in the transcript but a review. Just for the reference, the most important authors on a paper are the first and last author, the first author is the principal investigator and writer of the study results and the last author is typically the coordinating study center or lab.

The senator found a connection with a class action suit: Study 329 was cited in a New York (Hoorman vs. GSK) 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.”

Perhaps she did not want to give a wrong number and then be in real trouble for lying under oath, can anyone here tell me how much they paid in taxes in 2000 and be able to answer honestly under oath?

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.

This is interesting the Senator pummels the doctor for not reporting income that was not required to be reported by her University. If this is the case, even if she reported it where would they put it?

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.

Much of this probably falls on the University what he is saying sound sinister but perhaps much of this is miss understanding as opposed to malfeasance.

The other doctor pummeled is: 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.

It is possible that this was a mistake, as this was two years prior to the NIH grant, not a violation of Federal rules as the senator suggests.

Taking researchers to task one or two at time to move the NIH, without a chance for rebuttal, goes against the American spirit of fairness. Wouldn’t a debate be better than the one sided attacks we are now seeing, these researchers have devoted their lives to helping patients, exposing them on what may account to a reporting error doesn’t make sense.

Key Links:

Grassley Floor Statement