Grassley To NIH: Watch Those Academic Conflicts
10 CommentsBy Ed Silverman // October 27th, 2009 // 7:08 am
The move is the latest in a long-running effort by the Republican Senator from Iowa, who has been probing undisclosed financial conflicts of interest among academics who simultaneously receive grants from the National Institutes of Health and payments from drug makers for research or speaking.
His latest letter to the NIH follows an article in The Chronicle of Higher Education that noted several academics with alleged research conflicts. In particular, he cited Dr. Christie Ballantyne of the Baylor College of Medicine, who received over $34,000 for consulting with Merck about the Vytorin cholesterol pill. At the same, Grassley writes, Ballantyne was listed on several NIH grants concerning cardiovascular studies (here’s one).
According to current NIH regulations, which Grassley has cited repeatedly, Baylor should have reported to NIH that Ballantyne received more than $10,000 from a company. However, the article stated that Baylor was “confident that its rules guard against any financial conflict of interest, saw no need to tell the NIH of payments by Merck to (Ballantyne).” Why? The NIH asks the university only to certify that any conflict is being “managed, reduced, or eliminated,” not specific disclosure of industry payments.
Recently, former NIH director Elias Zerhouni acknowleged that academia hasn’t played by the rules. “People flouted the rules, didn’t disclose, and did it for years on end, repeatedly,” he told Nature magazine. “That tells you the problem is not Grassley. The problem is our current system of managing conflicts.”
As the Chronicle story noted, Merck and Schering-Plough, which jointly marketed Vytorin, were scrambling to promote their drug after a scandal over their Enhance clinical study in early 2008. The study, which was completed two years earlier but not publicized, showed the expensive pill lowered cholesterol better than Zocor (one of two drugs comprising Vytorin that was, by then, available as a cheaper generic). But it failed to show better results in preventing plaque build-up in arteries. Vytorin sales plunged amid the controversy (back story here and here).
Ballantyne and the other docs helped the drug makers push back by emphasizing lower cholesterol levels, the paper notes. In a March 2006 news release from Merck and Schering-Plough, he is quoted as saying Vytorin was “significantly better than (Pfizer’s) Lipitor,” while acknowledging the need for further studies “to confirm these findings.”
Ballantyne tells the paper he always pointed out in company-paid speeches that the benefits of adding Schering-Plough’s Zetia to Zocor are unknown. “I have no interest in helping a company to increase market demand,” he tells the paper, “and this did not ever appear to be the purpose of our advisory meetings.”
The disclosure, by the way, comes shortly after an an amended lawsuit was filed by the Schering-Plough pension plan alleging that executives at the drug maker suspected back in 2005 that the Enhance study was a flop. As a result, the lack of disclosure over the Vytorin results falsely inflated Schering-Plough stock, which dived when the trial was finally released in early 2008, the suit claims. It also discussed a ‘confidential informant’ who allegedly knew that Schering-Plough execs were aware of Enhance results much earlier than acknowledged (see the complaint).
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Lilly
all these rules on the books and no one is following them. excellent. The Fed Govt. does very little enforcement. SEC, HHS, NIH and the list goes on
Condor
So universities think they’re allowed to decide which laws they will follow? Astonishing. Or not so.
In any event, I’ve set Senator Grassley’s letter of inquiry — in easy read full text — right here.
Namaste
pharmavet
Ballantyne is a straight shooter. My company used him as a consultant, and he is data-drivem. No more, no less.
Thom
I think the fact that Ballantyne lends his name to company press releases proves that he is all about the science.
SP Vet
Bull! Like many other top KOLs, these guys are in high demand, get paid big bucks, and know exactly what they’re doing!
Disgusted
This is just the tip of the iceberg baby! Many KOLs work for multiple companies and end up raking in several hundred thousand a year for doing so. Did a little deeper and ye shall find many more skeletons in the closet!
FDAer
Lilly lets not forget agency OIGs (Inspector Generals). Why aren’t they watching the watchers.
katherine
seems to be a free for all out there.
Matthew Holford
“…The NIH asks the university only to certify that any conflict is being “managed, reduced, or eliminated,” not specific disclosure of industry payments…”
Is it fair to say that most people would be influenced by the receipt of a large sum of money? I think most would be well aware that if they didn’t follow the interests of the one making the payment, then there wouldn’t be any great likelihood of further payments. Because of this, we are sensitized to the concept of conflicts of interest.
Personally, professional people or not, I don’t believe these academics are above suspicion. More to the point, there is significant concern, at least amongst the blogging public, that they’re as corrupt as hell, but conveniently get away with it on the ground that we can’t read their minds to establish definitively that they’re pushing shite drugs, just because they’re getting paid to do so (fraud is notoriously difficult to prove, because of the mens rea element).
If we are unhappy that the academic institutions (in this case), are properly managing conflicts (and this very hands-off approach appears to be the one favoured by the NIH), then there seems little choice but to tighten the rules. Disclosure should be mandatory, and not a matter of discretion.
Matt
BP Man
They should also look at how much Schering-Plough gave Christie B. I believe it would dwarf what Merck gave him. I think he was paid huge amounts of money to run some KOl effort by them.