A new study finds overly broad conflict-of-interest (COI) rules create barriers between science and commerce that prevent the sharing of information necessary for the kinds of medical discoveries and treatments that have steadily improved quality of life.
According to the report by Richard A. Epstein, a visiting scholar at the Manhattan Institute, increasingly intrusive COI rules imposed by the National Institutes of Health (NIH) prohibit collaborations between employees of research institutions and public agencies and those working for pharmaceutical companies and other businesses, threatening to disrupt what has been a wide-ranging and productive exchange.
Degrading and Delaying Results
In “How Conflict-of-Interest Rules Endanger Medical Progress and Cures,” Epstein finds an expanded regulatory philosophy is likely to degrade the quality of research and delay provision of lifesaving medicines and treatments.
Epstein reports the NIH has forbidden nearly all contact between its scientists and those in the private sector without weighing the impact of such barriers.
“[A]n industry scientist may be the world expert in an NIH scientist’s area of research, and others could facilitate the translation of basic research into useful technologies, which is supposed to be one of the agency’s goals,” Epstein writes.
Overly stringent COI rules have gone too far, says Epstein. He notes the Food and Drug Administration (FDA) has started demanding extensive public disclosure of the financial ties and payments of experts appointed to committees reviewing drug licensing, even though a third of these positions are unfilled.
“Every well-run organization has interactions between government and private business. You pick people with the best reputation and expertise, then you ask them if they have any conflict of interest, and if they do, they can recuse themselves from the project,” Epstein said. “In the past, for the most part, if you made the disclosure that you had ties to private industry, you’d drop out of the project and that would be the end of it.”
COI and Drug Development
COI rules impede drug development, says Thomas Sullivan, president and founder of Rockpointe Corporation, a leading medical education company.
“At universities, about 10 years ago it was an honor to get a research grant from a big pharmaceutical company. Today, that is not the case, as universities have an anti-market view. A colleague of mine took a grant from a pharmaceutical company and had to keep quiet about it for fear that he might get blacklisted,” says Sullivan.
Sullivan says the cause of the change is that university culture tends to oppose market freedom.
“Many universities believe that all corporations are bad and that you shouldn’t work with them on research projects. There is also the intimidation factor—there’s a fear of being written up negatively by the press,” he explains. “University research centers have developed this idea that somehow, working with industry is bad. They don’t trust the corporations, so they don’t trust their research.”
“These rules will no doubt slow down drug development,” Sullivan says.
Business People ‘Excommunicated’
Epstein says COI rules ignore the fact that data errors typically don’t arise in private industry but instead from “young scientists trying to make a name for themselves.”
“Starting in the 1950s, the idea began that market actors were bad guys and if you worked in the market, you were automatically deemed a bad guy and you were tainted and could never be worked with,” says Epstein.
COI rules have lowered the boom on anyone doing research with private companies, he says.
“Thirty years ago, people would regularly go to a convention or an industry dinner and the salesmen would get their information about a new drug in front of them. They’d either act on it or not,” Epstein says. “Now no one wants to work with you, so it becomes more difficult for people to make a decision to do private research.”
More importantly, it prevents the three groups from getting together and sharing information, says Epstein.
“Once you disclose any connection [with business], people shut you out. This is a great danger to people. They have suspicion about anyone. Their idea is that disclosure is not enough, so you have to be excommunicated. As a result, the people sitting on these COI committees are people with no market experience or connections. They’re anti-market,” he says.
Epstein says the push for a COI crackdown is not based on a concern for patients.
“They’re making rules based on some kind of prophylactic rule where you’d let a thousand people die just so one person is not harmed inadvertently. They’d rather protect the ‘purity’ of the system than save lives,” he says.
Epstein says there are built-in safeguards for market-based research.
“If you’re a company putting a new drug out, you wouldn’t risk your reputation by promoting an inferior or an unsafe product. Instead, you’d want to promote your product that works and that people are going to want to buy,” Epstein says.
He says COI rules start from the assumption that there are no “good guys” in private industry.
“Oftentimes, the people who charge others with violating COI have ulterior motives. The old model worked just fine without all the new rules,” Epstein says. “The clear problem with government policies is that strict separation that prevents conflicts of interest also prevents cooperation and collaboration.”
Kenneth Artz ([email protected]) writes from Dallas, Texas.