Late last summer, the Association of American Medical Colleges attempted at the eleventh hour to significantly weaken proposed rules to tighten up conflict of interest policies for NIH-funded biomedical research.
Now the rule, which would require institutions to collect and report more information about their investigators’ financial ties to drug and device companies, is facing threats from another corner, as OMB trawls the regulation fountain for small savings.
But looking to detooth or block conflict of interest regs isn’t the answer. We know from ProPublica‘s review of company payments and other recent reports that big dollars from pharmaceutical companies are still flowing into the hands of clinicians, who are often also publicly-funded researchers. And we know from a series of Senate and media investigations that the current honor system of requiring researchers to report conflicts with the drug industry is broken in big ways.
The new rule would help fix that by creating common protocols and measurements, helping to ensure all NIH-funded institutions are reporting and managing COIs in the same basic way.
The AAMC and AAU’s earlier attempt to weaken the NIH proposal illustrates the difficulty an association that represents so many institutions can have setting a high bar, and there’s sometimes a tendency to recede to the lowest common denominator.
Indeed, many academic medical centers have been very proactive in taking steps to better manage the potential financial conflicts of their faculty. But the Senate’s investigation revealed many medical schools were guilty of lax oversight, and this would help them avoid similar problems in the future.
Recent sanctions of some high profile researchers at the center of the conflict of interest storm, including a prominent group of Harvard psychiatrists, remind us why NIH proposed the new rule in the first place, and of the potential costs of not changing them.
Harvard psychiatrist Joseph Biederman contributed to a 40-fold increase in pediatric bipolar diagnoses between 1994-2003, running NIH-funded research even as he was on the payroll of the companies whose drugs he was studying – netting $1.6 million from the drug industry from 2000-2007 alone. He urged one company to fund a Harvard research center “to move forward [its] commercial goals.”
The explosion of pediatric bipolar treatment is a part of a larger rise of mental health diagnosis and treatment. One in 10 Americans over age six now take an anti-depressant, and the newer class of atypical antipsychotics—about which relatively little is known—is now the top-selling drug class in America.
So how much has this high-stakes blurring of the line between research and marketing cost us?
In its assessment of the new rule, HHS estimates that it will take an institution one hour to review an investigator’s conflict, and two hours a year for an investigator to adhere to the reporting rules. It estimates only an incremental cost for institutions to post the information to a public website, since all of them already have such websites.
So how much is it worth to us to make sure that future leading-edge clinical science–which guides so much medical practice in this country–is done with transparency and objectivity? How much is it worth to improve a system that has clearly been ineffective in ensuring that taxpayer-funded pharmaceutical research is about good science, not good marketing opportunities?
The Administration would do well to calculate all this before watering down important reforms needed to ensure responsible use of taxpayer funds.
–Kate Petersen, PostScript blogger