Has Conflicts Of Interest Pendulum Swung Too Far?
16 CommentsBy Ed Silverman // November 2nd, 2010 // 7:36 am
For the past few years, sorting through conflicts of interest - and what to do about them - has been a preoccupation for people in and out of the pharmaceutical industry. As new regulations and codes take shape, however, one wag says the pendulum has swung way too far and that the effort by “medical elites” to prevent conflicts is so dogmatic that, ultimately, patients will be hurt.
In an essay, Richard Epstein, a visiting scholar at the conservative Manhattan Institute think tank and a New York University School of Law professor, writes that “the policies of government agencies and private institutions concerning risk have gone way off to one side. The response is wildly disproportionate to the supposed severity of the turn.”
Among his contentions: the FDA financial disclosure rule for advisory panelists has resulted in “nearly one-third” of committee seats going unfilled; since the National Institutes of Health forbids its scientists to communicate with colleagues in the private sector, experts are denied the free exchange of ideas essential to medical innovation; now that some medical societies restrict members from accepting speaking fees, experts are unable to help new drugs come to market; because Harvard-affiliated hospitals monitor compensation their docs receive for sitting on corporate boards, the docs will devote less time to their hospital duties; and a Massachusetts bill that prohibits drug and device makers to give gifts forces training to take place elsewhere.
“We should cast a skeptical eye on the zeal that propels concerned citizens and policymakers to undertake new regulatory initiatives. It is common to justify a new round of restrictions at every phase of pharmaceutical and device regulation with the war cry ‘Better safe than sorry.’ That maxim works well in explaining why ships should stay in port when visibility is poor, the wind is high, and the terrain is unknown. But this image does not carry over to issues of pharmaceutical research, where regulations routinely deny even prudent individuals and firms a “safe harbor,” where they can collaborate without fear of sanction.”
So Epstein proposes releasing all experimental data and disclosing funding of services before new drugs and devices are produced; he suggests the FDA should grant more waivers to experts on advisory panels, so experts do not have to disclose personal financial information, and he believes the NIH should develop what he calls a “conflict-of-commitment policy” that brings scientists from government and academia to collaborate on projects.
Pendulums often swing back and forth, but Art Caplan, who heads the BioEthics Center at the University of Pennsylvania, notes that, while Epstein may be wildly out of step with those who have worked to foster greater disclosure, his central notions may be a harbinger of what could come after the today’s elections if conservatives hold sway.
“This report may not command much attention, but in my view, it’s a real signal of what is likely to happen to conflicts of interest policy if Republicans take control of the House and/or the Senate,” says Caplain. “There is a strong anti-regulatory stance in Estein’s piece and what is said at places like the Manhattan Institute is frequently echoed on the floor of Congress or soon thereafter. Those who have come to equate GOP policy about pharma regulation with Senator Grassley, I think, are sadly mistaken. Epstein is much more the poster child of the Tea Party and the Liberatarian components of the GOP, which are growing in ascendancy.”
Bill Clinton
Epstein is a blowhard and libertarian hack who always argues for less regulation. More importantly, his essay is riddled with errors.
There’s no rule at the NIH that “forbids its scientists to communicate with colleagues in the private sector.” There are all kinds of joint collaborations between NIH scientists and industry. The NIH employees just can’t take money on the side for doing so.
Can’t Epstein get one of his law students to fact check this nonsense?
harpy
ha! this ol’ boy is so full he squeaks! I could maybe take him a little seriously if just one premise of his argument dealt with the thousands of people who have been harmed or killed by pharma chicanery. he skims over the reasons conflict-of-interest policies were deemed necessary and offers no solution in their stead. what a whiny git.
and please, “medical elites”? and what, praytell, does he think he is? a sampling of his curriculum vitae:
“Manhattan Institute visiting scholar and one of the nation’s most prolific legal thinkers…serve as the James Parker Hall Distinguished Service Professor of Law at the University of Chicago, where he has taught since 1972, until January 1, 2011, at which time he will become a lecturer there. In 1983 he became a senior fellow of that institution’s MacLean Center for Clinical Medical Ethics…holds undergraduate degrees from Columbia College and Oxford University and a law degree from Yale. He was awarded an honorary doctorate of law by Ghent University, in Belgium.”
why, the man’s a peasant! who doesn’t have an honorary degree from Ghent University?
Anne PME
I worry that we are failing to include actual clinicians…clinicians cannot afford to take the time to participate because they earn their money treating patients. Also, clinicians’ their med mal carriers likely would warn them that they are at higher risk of being sued over errors and ommissions if they participate as an expert panelist and work to fix our broken system.
RPJ
For those who believe COI enforcement is swinging too far to the strict side of the street, rest assured that this trend is more than offset by arrogantly blind eyes of representatives and senators who believe they are so close to God that they needn’t bother with COI rules for themselves. Much as I appreciate Senator Grassley’s work on this issue, it is more than a little ironic to have members of Congress waving the accusatory finger at us. The magnitude of the booty they receive and the world-wide human impact of the votes they make leave even the Nemeroffs of the academic/clinical world looking like pikers.
Betsy
Let us not swing back to the deregulation of the Reagan era and its dangerous consequences. Let us also remember how corporate America is buying today’s elections. And giving the FDA more power to grant waivers is ludicrous. As it is the FDA, whose decision makers on new drugs are on Big Pharma’s payroll, is heavily influenced by corporate America.
Give us a break.
Louis XVI
Epstein is one of our garcons!
Apres nous le deluge! Sauve qui peut! Caveat emptor! Survivor Island!
industry insider
Why do we need 18 people on an Advisory Committee anyway? An even dozen non-conflicted members would be just as fine with me, IMHO. AP’s used to be much smaller, until it was decided in the interest of “fairness” to add everyone down to the head of the Sewer and Water Board.
EddieVos
Eight authors of the U.S. ATP III “cholesterol guideline” update got money from average 10 drug companies or which 1 was a government employee also pocketing $114,000 PLUS stock options: http://tinyurl.com/329tlsp [L.A. Times]. The final author is a person full time employed to increase the proportion [.. of Americans] who adhere to their cholesterol-lowering regimen, yet this person declares NOT to have a conflict!
The damage done in wrongly and uselessly prescribing such ‘Cholesterol Pills’ alone is told in the tens of billions of dollars, such is the result of conflicts that, in this case, were only belatedly declared under pressure.
Clearly, we’re better off with zero conflicted experts analyzing the data. The “purist” lawyers promoting less emphasis on conflicts are costing us dearly, in money and in health. We need stricter guidelines, not fewer.
industry insider
Anne, when I was running investigaror meetings for new clinical trials we heard the same arguments from the clinicans, i.e. that they can’t afford to take the time off from their practices. When we offered to hold the meetings over the weekend they complained that they didn’t want to give up their weekends. As a compromise we decided that the only way to get them to such a mandatory meeting would be to compensate them fairly for their time away from the office, much as a law firm would compensate a medical expert witness for his/her time away from the office. Rightly or wrongly, if the clinicians were compensated for their time at the AP meeting, that might help attract more clinical people.
Since committe work usually involves one hour of prep time for every hour of face time, they may need to be compensated for that as well.
cliffintokyo
Its way too soon in the corrective process for the pendulum to swing back, even a little.
Mistrust of doctors still seems to be growing, if there is any discernable movement.
Ted
“Better safe than sorry” shouldn’t apply to the health of human beings? Only to ships in harbor? Wow. You have interesting priorities. I’m really glad the rest of the country places more value on human health and safety than you do.
Ted
RPJ - What’s your point? That pharma shouldn’t be cleaned up if politicians aren’t cleaning up their COI? That pharma should be allowed to operate in the Wild West until such time as the rest of the world can cast stones in glass houses? Wrong answer. Maybe if pharma sold radios and televisions rather than drugs that people ingest. It is never too early to clean up pharma and make the healthcare world safer for the people it claims to want to help.
Josh
I always find it ironic that Senators/Reps (the ones that make the actual laws for the industry) can own stock in pharma companies, but FDA cannot.
harris miller
What an idiot. The entire health care industry is built on conflicts of interest. From the AMA’s control of CPT codes to the fact that big pharma will not engage in testing to identify patients whose genetic profile makes them bad candidates for the drugs they otherwise want to sell.
Oh yes, that’s the marketplace we are told. Horseshit it is. It is nothing more than the lack of oversight to deflect the impact of COI on the marketplace. We taxpayers pay for big pharma’s right to sell in that manner.
Stop wasting our resources you bastards.
Jim
The problem is that financial conflicts of interest are only the most obvious ones, and not necessarily the most pernicious.
The Soviets decided early on to run everyone with any possible financial interest out of the halls of power. Soon the only ones left in a decision-making role were those motivated by the desire for power as an end unto itself.
I think it was BF Skinner who said that “there is no morality, only countervailing force”. The more people you strip out of the decision-making process, the less countervailing forces those remaining have to deal with.
David Avitabile
Does this guy mean to say that an overzealous bureaucracy could inhibit scientific innovation in this country?
This is blasphemy. Especially if you happen to be a member of the bureaucracy.
Why, talk like that could end up puting thousands of functionaries’ jobs at risk.
Therefore, I simply refuse to accept that there could be any merit to this argument.
As for those who become hysterical when any mention of overzealous regulation is brought up–those who claim that all critics of our increasingly bloated and antiquated regulatory system would prefer to have pharmaceutical companies operating in a “Wild West” environment–there is something called a “Middle Ground.”
Nobody, aside from a few kooks, is advocating total deregulation of the life sciences industry. That would in fact be insane.
But there is a point at which an overzealous bureaucracy is at risk of suffocating any semblance of common sense, along with any ability to understand and align itself with the concept of “acceptable risk.”
I believe we reached that point years ago.