Grassley: Universities Aren’t Following The Law
13 CommentsBy Ed Silverman // October 10th, 2008 // 8:23 am
For the past several months, the US Senate Finance Committee has been investigating undisclosed conflicts of interest involving academic researchers who receive NIH grants and pharma funding. At issue is whether universities are fulfilling their requirements to adequately monitor these disclosures in an effort to maintain scientific integrity and objectivity (back story here, here, here, here and here. Nature Medicine spoke with Chuck Grassley, the ranking Republican on the committee, about the probe. This is an excerpt…
Nature Medicine:What are you hoping to accomplish?
Grassley: NIH gives $24 billion worth of grants…The law requires the universities to have their researchers report outside income. We found out the law wasn’t being followed. The universities were not doing their job of gathering the information. We started looking into it and got inconsistent information between the researchers and what the university had. We found out that NIH was not really enforcing current law. It’s a matter of making sure the law is followed and making sure that we make all this information transparent. Let the sun shine in…
Nature Medicine: Do you feel, then, that that is reflective of a widespread, systemic problem or some isolated pockets of less-than-perfect behavior?
Grassley: It is systemic. But it’s systemic not as a planned thing. Because of the lack of oversight, it just happens. I don’t think a university is out to see what they can get away with. They just aren’t doing their job.
NIH has a lot of power…And I want the director of NIH to use that muscle to make sure universities are doing what they’re required to do. That, they’ve been very lax in. I think that the NIH director ought to be as aggressive as he can…All he’d have to do is withhold one grant or bring back money from a grant if somebody’s not doing their job. The message would get out pretty fast…But I kind of sense an attitude at NIH that “things have to change, but it’s going to take a long time to change them.”
Nature Medicine: Virtually all of the unreported payments that you have publicized so far went to psychiatrists. Do you think that psychiatry as a specialty is more suspect in failing to disclose these conflicts, and, if so, why?
Grassley: I don’t have any reason to believe that psychiatry over any other medical device or any other subspecialty of medicine.
Nature Medicine: And yet recently you asked the American Psychiatric Association to give you a detailed accounting of the nature and extent of its support from drug companies.
Grassley: Well, we were following up on some of the other investigations we were doing. We wanted to have another source of information. I’ve sent letters asking questions about financial transparency and financial relationships between doctors and industry to several medical societies, including the American Psychiatric Association this summer and the American College of Cardiology and the American Heart Association earlier this year.
Matthew Holford
“It is systemic. But it’s systemic not as a planned thing. Because of the lack of oversight, it just happens. I don’t think a university is out to see what they can get away with. They just aren’t doing their job.”
But if the universities are still doing it, in a couple of years time, and academics are still under-reporting, when both have been told what their obligations are, then it’s reasonable to assume there’s intent involved. At that point, one might wish to understand why disclosure is being withheld.
Matt
Doug Bremner MD
The bottom line is that if the NIH starts pulling grants, they will get the universities attention real fast. Universities get 54% or so of the cost of grants as “indirect” costs which they are supposed to use to support research infrastructure expenses (in fact, little of that gets back to the researchers who wrote the grants). The NIH could start doing that now.
I am not sure if the senator is correct in saying that it is the “law” or just policy.
I still have a beef with the senator in focusing on psychiatry. Let’s open it up to all medical disciplines. Let the sun shine in, senator.
BOB FIDDAMAN
Rome wasn’t built in a day Doug. Perhaps, Grassley’s questions will open a lot of doors and many more questions about medicinal disciplines will be asked.
End of the day, Nemeroff, Keller et al are as bad as the folk that paid them.
Fid
Gina Pera
Has anyone here mentioned Grassley’s #2 campaign donor, Blue Shield, and any possible link to his fervor to de-legitimize psychiatric medications? Why else is he picking on this field, or have I missed some history?
After all, these are expensive medications, and from what I’ve seen, insurance companies are doing their darnedest to limit access to the newer formulations.
Thom
Doug, a couple of things
1. You’re wrong. It’s the law. You can read the regulations here yourself.
http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm
2. You’re wrong. Grassley has previously sent inquiries to the American College of Cardiology and is also looking at Medtronic, which hires surgeons.
American College of Cardiology
http://www.pharmalot.com/2008/01/grassley-starts-his-own-vytorin-investigation/
Medtronic
http://www.nytimes.com/2007/09/27/business/27letter.html
In both cases, all you had to do was spend five minutes on Google. But if you are more content in making baseless charges, then have at it.
Doug Bremner MD
Thom, he only sent a letter to the ACC, which by the way acted shamefully by sending faxes to every cardiology dept in the country (including ours) telling docs to continue prescribing vytorin, which they get millions in funding each year from a number of companies, including S-P. Hardly an investigation. The medtronics thing was also a letter. There is nothing involving individual academic cardiologists, or any other specialty.
Thom
Doug, I like you. You’ve got that clarity of vision so often found in people of high talent. Question. Did you go to med school?
By the way, two minutes on Google finds this letter that Grassley sent to Medtronic
http://preview.tinyurl.com/4zcan2
As you can see from Question 3, there are several doctors Grassley is interested. The unfortunate thing for these guys is that when Grassley finally releases this information they won’t be able to bitch moan and cry that they are being unfairly singled out.
Because the psychiatrists have taken that excuse as their own.
Grassley letter:
“Please provide the Committee with a list of all payments or other transfers of
value made to the following individuals: Lawrence G. Lenke, Jeffrey C. Wang,
Behrooz A. Akbarnia, Thomas A. Zdeblick, Rick Delamarter, David Polly, Kevin
Foley, Kenneth J. Burkus, Regis Haid, Rick Sasso, K. Daniel Riew, Steven
Garfin, Choll W. Kim, Scott Boden and Stephen Papdopoulos. For each payment
or transfer, please include the date, amount, and reason for the payment or
transfer. This request covers the period of January 2000 to the present”
Doug Bremner MD
Yes, I did go to med school, psychiatry residency too. Thank goodness I had a liberal arts education so it didn’t completely ruin my capacity for logical thought (an effect that psychiatry training can have on someone, as I was told by a PhD in epidemiology once).
So it looks like Grassley asked about the KOLs in neurosurgery too, although it has been over a year, maybe Medtronics is dragging their feet. Aren’t they the ones that were sending docs to a strip club and letting them go to the ‘VIP room’ on the expense account?
I did find his letter strange, though. Isn’t it common knowledge that companies pay for CME, select the educational material, and pay the KOLs for consulting?
Maybe I am out of the loop or something.
It is hard not to see this as a type of payola. I put the references for how early adaptors influence the ‘herd’ (i.e. docs in private practice) on my website. It is obvious that industry has figured out that the KOLs are early adaptors who have a heavy influence on the field.
I, for one, will only consult to French drug companies. They have better food, and they don’t talk about work at dinner.
Doug Bremner MD
Oh, btw, Medtronics also made the TENS units, these goofy little electrical stimulators we used to put on the backs of patients with low back pain. A doc at UW did a study that showed that they didn’t work, and when they couldn’t get his funding pulled, they took the creative approach of using their influence to reduce funding for the entire NIH institute that they got funding from! He wrote about it in a book called ‘Hope or Hype.’ A good read.
Thom
Doug, can’t remember where I read it, but companies pick KOLs because doctors respond better to a “sales pitch” from another doctor that from a drug sales rep. There’s even some sort of return on investment from this practice that drug companies follow. I think the return on drug reps is 2:1, but it’s 10:1 on doctors.
Can’t remember where I read that.
Also, from the way you describe it with the companies picking the doctor for the CME course….I imagine that violate ACCME guidelines. Not that I don’t doubt that your understanding is probably exactly what happens.
Doug Bremner MD
The return on investment for KOLs is much greater than that. And they are not doing a sales pitch, they are just showing a set of slides. The problem that I had (have) with that is that when pharma provides the slide set and insists that it not be changed, that is tantamount to a sales pitch. I got dropped several years ago because I insisted on changing the slide set. Before each talk we had this scramble to change the slides. They told me they couldn’t change them because they were FDA approved (Ha ha!), or that they had to guard against docs talking about off label usage of drugs (Ha ha ha ha ha ha ha!). They finally stopped inviting me. Ta ta. Later when I gave grand rounds at a major university I was told that I wasn’t on the ‘list’ of speakers that the pharma sponsors would pay for, so they had to scramble to get the funds to pay for my talk.
Christopher
So were you paid for your talk Doug? Just interested.
Andrew
he’s got it right! In fact, the more prominent the university, the less the tendency to follow the law. The top dogs think that they’re above it all. The Ivies, Duke, Stanford, Baylor - they’ve been raking in bundles for years. The so called opinion leaders have gotten rich on drug company money. Not only that, but a lot ofg it’s tax-free! Let’s get all of the big shots to open up their books. What you see will no doubt surprise you!