New NIH rules about conflicts of interest are a swiss cheese of loopholes

The newly announced rules on financial conflicts of interest among federally funded researchers are certainly an improvement on the existing regulations issued by the National Institutes of Health in 1995 (which were never enforced anyway). But as ethicists and consumer advocates note -- see here and here -- they fall short of true reform largely because they continue to leave the reporting and management of financial conflicts up to the discretion of institutions who are themselves increasingly dependent on private-sector funding and thus imprisoned by their own conflicts of interest.

Why is this a problem? As Greg Petsko, a researcher at Brandeis University who is studying Parkinson's and Lou Gehrig's disease, recently explained to me: "“If you are accepting any sort of reimbursement or personal funds from any organization that might benefit from what you’re doing scientifically or from public statements you’re making, you have a moral obligation to make that connection clear so people can decide for themselves how much weight they want to give what you’re saying.”

In other words, studies show that financial conflicts can sway the judgement of doctors and researchers who receive federal funding, and it is important that the public know just exactly what those conflicts consist of - so they can make up their minds about how valid the science conducted by these conflicted researchers is.

Yet the new rules promulgated by the NIH don't make it easy for consumers to find out about such conflicts of interest. When the revisions were first proposed, they contained a provision requiring universities to disclose their researchers' conflicts of interest on a publicly available website. But that provision has been dropped under pressure from university and industry lobbyists, and instead institutions can decide for themselves how they want to release conflict of interest information. The only requirement is that if someone inquires about a specific researcher's conflict, the institution has five business days to respond -- see here.

Under the new rules, institutions now have to disclose more information about their researchers' conflicts. Previously, each institution only has to report that there was a conflict to the funding agency and note that it was being managed, and there are many instances when universities didn't even do that and were never sanctioned for their failure to disclose. For example, Brown University School of Medicine never bothered to disclose to the NIH the hundreds of thousands of dollars in personal consulting and speaking fees that Dr. Martin Keller, then chief of psychiatry at Brown University, was receiving from drug companies each year, despite the fact that Keller was receiving millions of dollars in federal research funds from the National Institute of Mental Health -- see Boston Globe article I wrote here. But neither Brown nor Keller were ever publicly sanctioned for that failure to disclose.

Under the new rules, institutions are now supposed to disclose more information about the conflicts, including the specific holdings or financial interest, the value of the conflict, how this relates to the research in question and why it is deemed to be a conflict of interest. But again, how they disclose this information to the public is up to them, and if past history is any guide, there will be little enforcement of such rules by the NIH itself. As Sally Rockey, the NIH deputy director for extramural research, acknowledged in a brief teleconference about the rules yesterday, the federal agency has never terminated a grant because of non-compliance -- see here.

Dr. Bernard Carroll, writing in Health Care Renewal, points up another loophole with the new rules:

The revised regulations do not close the regulatory loophole through which Charles Nemeroff strolled when he moved from Emory to the University of Miami. We covered that incident several times on this blog last year. Though Nemeroff was under a 2-year sanction and banned from participating in NIH-funded research at Emory, his friend Thomas Insel, Director of NIMH, assured the dean of the medical school at Miami that Nemeroff was in good standing to apply for NIH funding when he moved from Emory. To underline the point, Insel displayed the bad judgment of appointing Nemeroff to 2 new NIMH review committees.Do today’s revised regulations prevent a repeat of this administrative travesty? No, they don’t. There is some mention of ensuring oversight if a sanctioned investigator wishes to transfer a grant to a new institution, but nothing to prevent the Nemeroff-Insel dance from being repeated.

One can't help but wonder if the weakened NIH regulations are part of the massive rollback in federal regulations by the Obama administration that I recently read about. What happened to our President's spine?

What's behind the growing rate of scientific retractions?

The retraction of studies in medical and scientific journals has surged in the last decade, according to separate analyses done by the Wall Street Journal and Retraction Watch.

In its page-one article today, the Journal noted that while just 22 retraction notices appeared in 2001, there were 139 in 2006, 339 last year and 210 so far this year. Retraction Watch, in a blog celebrating its one-year anniversary, said it has recorded 200 retractions over the last 12 months, compared to an annual average of about 80 over the previous 10 years.

Why are retractions on the rise? According to the WSJ, some journals argue that the increase indicates their rising vigilance in detecting errors. Others blame the increasingly competitive environment for research grants and career advances in science and medicine.

I would point to two other key factors. First and foremost, there's the pressure that the pharmaceutical and medical device industry exerts on researchers to come up with positive findings in clinical trials. (This starts with cherry-picking pliable researchers for specific studies and ensuring their cooperation with lucrative speaking and consulting gigs and then having the studies themselves ghost-written to make the drug or medical device in question look safer and more effective than it really is). This is known to have happened with clinical trials for Paxil (which Side Effects focuses on), Celexa, Zoloft, Vioxx and Avandia and several medical devices including a widely used bone growth product made by Medtronics (which The Spine Journal just devoted an entire special issue to).

This kind of industry-academia collusion, of course, has been going on for awhile. What's different now is the heightened scrutiny of scientific misconduct by the media and the steady drumbeat of blogs like Retraction Watch, POGO and Pharmalot. As a result, many journals are now adopting a tougher line and investigating errors more thoroughly. And that's exactly how it should be.

With Big Pharma on campus, who is looking after the public interest?

Medicare and social services for vulnerable Americans are not the only programs on the chopping block with Washington's deal to raise the debt ceiling and cut trillions of dollars in government spending. Looming ahead may be deep cuts in funding for medical and science research, and that raises the specter of growing collaboration between academic centers and industry, including pharmaceutical and medical device companies.

Even before the debt deal was reached, partnerships between Big Pharma and universities have been on the rise, according to an article in the current issue of Chronicle of Higher Education. The article, Big Pharma Finds a Home on Campus, details this growing collaboration and the "many new ethical and practice questions" it raises, including the increasing potential for conflicts of interest.

There may be some beneficial outcomes to these partnerships in the development of drugs to treat intractable diseases. But what concerns many is this: how can institutions that are increasingly reliant on funding from private companies do an adequate job of policing conflicts of interest among their own faculty? It's akin to having the fox guard the chicken coop.

"I'm not sure that universities can police conflicts of interest when they become so reliant on [private sector] funding," said Peter Conrad, Harry Coplan Professor of Social Sciences at Brandeis University and author of The Medicalization of Society. According to Conrad and others, academic centers are already doing a poor job of enforcing their own conflicts of interest policies. He points to the "slap on the wrist" Harvard Medical School gave Joseph Biederman for failing to disclose millions of dollars in financial ties to drug makers; see background here.

"Biederman used his name and position as a way of promoting the use of antipsychotics for childhood bipolar disorder," Conrad said. "He was basically an entrepreneur for the bipolar diagnosis in children and using drugs that have not been tested and approved for children."

Conrad believes such conflicts of interest will only worsen in the coming years as federal research money becomes scarcer and universities turn to industry to keep their science labs humming.

"I think this is just the beginning of the privatization of research," he says. "It's representative of the tilt in society towards business interests over public interests." Conrad cited the recent Supreme Court decision that allows corporations to give as much money as they want to political candidates an another example of that tilt toward allowing commercial interests to take precedence over public interests.

Indeed, university and industry lobbyists have already succeeded in convincing the federal government to drop a key provision in the proposed new NIH guidelines for conflicts of interest among federally-funded researchers. According to Nature, a cornerstone of the new guidelines — a series of publicly accessible websites detailing financial conflicts among academic researchers — has now been dropped.

Consumer advocates have roundly criticized the move. "It greatly diminishes the amount of vigilance that the public can exercise over financially conflicted research being funded by the NIH," said Sidney Wolfe, director of the Health Research Group at Public Citizen, in Nature.

My guess is that universities didn't want that much transparency out of fear it might embarrass their star faculty rainmakers and stifle lucrative partnerships with industry. After all, why bite the hand that feeds you?