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, 2008SPEECH 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.
15 Comments
"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."
- Sen. Grassley
"Its a strange world after all."
- Disney
I am so proud that the country has at least one senator who is standing up to the lethal stew that is the pharmaceutical industry. Perhaps if we get Barack Obama, he will replace the empty shell of the FDA with an agency that actually protects the public health instead of allowing people to die.
And perhaps the DOJ will bring fraud charges against companies like Lilly, for which there is clear evidence of it - including the evidence of thousands of dead people.
Sorry I misquoted Disney: "It's a _small_ world after all." That actually works better too.
Not confident about DOJ. Given track record, very unlikely, but who knows? Re: the candidates, I only hope one of them has the "hockey puck" to address these issues. Haven't seen it yet.
Anne? I hate to break your heart (it broke mine)- Obama supports mental health parity, and he co-sponsored the mother's act.
No change in that.
Anne? I agree with David S.. As you know, I love my trips to Washington, and I can assure you, Obama could care less about the safety and efficacy of the medications we give our children. The Senator is a blowheart, and is out of touch with reality!!!!!!!!
Claus - You are out of control and should either find control or leave.
We are a diverse group. But I will wager that every one of us - leftists, rightists, centrists, corporatists, insurers, anti-insurers, and every other epithet in your repertoire (and not in your repertoire) would agree with the sentence above.
If there is anyone not in agreement, please say so.
If not, it is unanimous.
Believe it or not (you won't), I wish you the best. It's just that I wish us the best too. And the best thing for you, and for us, is a long chilling out.
JiM, You're probably right but it's not your call. We've had - and still have - eccentrics, egomaniacs, mike hoggers, snipers, cynics, prognosticators, advocates and naysayers. That's the charm of this place we frequent, but Ed is the host of this garden party and as such decides who goes. Claus may well be the Weakest Link but it's Ed's call not ours.
(Besides, where would one stop weeding out those with whom we disagree or who somehow don't fit one's idea of propriety?)
Anyway, I think Claus is tiresome and inappropriate but has claim to airtime until Ed shuts down his mike.
Claus, Your comments are becoming tiresome. Get more creative than this. Notwithstanding my earlier comments to JiM you really need to step it up if you are going to persuade people here. I already said 2 days ago that Ed is as straight as an arrow. Your rants about advertisers are off target. He doesn't sell advertising and editorial control - as you should know - is discrete from commercial. Drop it - it's old and flaccid.
Supremo, This isn't a biased blog. The people who comment have opinions. I am more supportive of the pharma industry than most here - I worked in it and I work around it now. But I don't have a particular axe to grind one way or the other; just enjoy reading and sometimes participating in the discussion. But when one or more dominate - and they do - without listening it becomes very dull and uninteresting. And as I have said more than once, but will no more, Ed happens to run a very open and inclusive blog site here. You should recognise that before reloading and spraying invective. That's all. Get some sleep and don't tell me I'm a hypocrite. You have no idea.
Oh, dear! In the words of Mrs Merton "let's have a heated debate!"
What do I think about psychiatrists? I don't know, to be honest. They're a very secretive bunch - I'm still drawn to Joe "where you going with that gun in your hand" Biederman's refusal to respond to critics, because, he said, he wrote 30 academic articles a year, and that meant that he was the authority, and nobody could touch him (he didn't put it in exactly those words, but I think that was the gyst). So, if we don't like the look of what they're doing, we may not scrutinize them?
I don't think that looks like a very strong system, to me. I also don't like the way that drugs are routinely farmed (heh! play on words, there!), out, when there doesn't seem to be a whole lot of evidence that they work, in any sense. I also don't like the idea that any single person, psychiatrist or otherwise, gets to be the Final Arbiter of Truth, and say what appropriate behaviour is, and to denounce somebody as a witch (sorry, that should read "diagnose somebody as mentally ill"), solely on the ground that they don't like the solutions that a person has developed for dealing with certain life situations.
Psychiatrists have a very limited view of what is appropriate, I think. Certainly if they follow the line of Joe B.D Mann.
Matt
" I also don’t like the idea that any single person, psychiatrist or otherwise, gets to be the Final Arbiter of Truth, and say what appropriate behaviour is, and to denounce somebody as a witch (sorry, that should read “diagnose somebody as mentally ill”), solely on the ground that they don’t like the solutions that a person has developed for dealing with certain life situations. Psychiatrists have a very limited view of what is appropriate, I think. Certainly if they follow the line of Joe B.D Mann. Matt"
Absolutely on target , as usual Matt : )
Psychiatrists somehow think that their profession entitles them to unquestioned power and knowledge. Ironic, given that their "knowledge" of mental illness has no basis in scientific fact and their practices are little more than stabs in the dark.
"Once the Americans became convinced there is a basement to which psychiatrists hold the key..."
-Allan Bloom
"Claus" raises a good point (if I read it correctly) Why HAVE these practices become so big?
First it is important to recognize that virtually all our federal agencies have been subverted. FDA has been subverted - or Paxil would have never found itself on the market to begin with. If it wasn't still subverted, Paxil wouldn't STILL be on the market. As to HOW these agencies are subverted, I recommend reading Fletcher Prouty's, The Secret Team. With what's outlined there - and what is outlined in the 2004 IWG release, US Intelligence and the Nazis, you'll find the foundation of this house that is our country consumed by termites almost entirely. THAT's how.
In the matter of SKB's merger with Glaxo, The Securities and Exchange commision greenlighted the merger WITH big problems associated with Paxil surfacing... allowing essentially a corporation (if it were a person) to avoid murder charges, simply by "getting married".
And there again - why?
You follow that "why", and you'll end up seeing things you'll find hard to believe. And when you view our country's matters through the lens of how and why these pharma matters have gotten so out of control, it all begins to make sense. And it's not a comforting thing to behold.
Oh - I should clarify:
I certainly don't believe this conspiracy is being carried out by everyone in the health industry; there are a lot of well-meaning people with no other interests than to help people. But one of the things that's been subverted by psychiatry since WW2, are our universities; if you change what is taught, you change what is learned.
One thing intelligence warfare has in common with martial arts is, you use your opponent's strengths and weaknesses against him/her/it.
And that's what this is - warfare. With pharmaceuticals (and concepts, and advertising, etc.)as weapons. ANYONE who supports medications like these is either malintentioned, or just doesn't get it, and is simply on the bandwagon, believing what they are told, simply because it comes from the university. Or the doctor. Or the politician.
The circumstances we have could not be more Orwellian.
I think the most overwhelming evidence in support of the notion of mala fides on a grand scale is that when one says "hey, something's wrong, here," one gets stonewalled. There are a lot of people who've expressed concern, and the industry's (in its various guises), response is, variously, to put up the shutters, blame the patients, bully, fudge and lie.
I don't see much point in validating their approach by continuing to try to talk to the halfwits, to be honest.
Matt
So which approach might you prefer?