Rep. Andy Harris, a Maryland Republican and medical doctor, has broken with the scientific mainstream during the coronavirus pandemic — decrying stay-at-home orders and warning of a “cult of masks.”
Now the five-term congressman has joined the hunt for coronavirus treatments with an unpaid side gig overseeing a drug company trial. Harris is one of three members of the data and safety monitoring board for the trial run by NeuroRx, a small Delaware company whose CEO and founder has longstanding ties to the congressman.
The members of the board are responsible for monitoring safety and efficacy data from the ongoing trial, which started in May, and have the power to end the study if problems arise. The drug in question, aviptadil, was created in 1970 to treat lung inflammation, but never reached the market. NeuroRx is now investigating whether it can help Covid-19 patients with acute lung failure.
Harris’s role is an unusual one: Former FDA Commissioner Scott Gottlieb told POLITICO that he’d never heard of a sitting member of Congress serving on a data monitoring committee for any drug. The arrangement doesn’t appear to run afoul of House ethics rules because Harris is not being paid by NeuroRx and does not own a stake in the company. But several bioethicists questioned his lack of experience in evaluating data from drug trials, and said that his close ties to NeuroRx CEO Jonathan Javitt could complicate matters if problems arose with the company’s study.
“The concern about bias wouldn’t arise unless the decision-making [on data from the trial] was difficult,” said Susan Ellenberg, a biostatistician at the University of Pennsylvania, whose research focuses on the ethical issues related to clinical trials. “If the data are such that it’s a hard call as to whether to stop the study or not, that’s when the personal connections seep into consciousness,” added Ellenberg, a former FDA staffer who wrote the agency’s guidance document on data monitoring committees.
In a statement to POLITICO, Harris — an anesthesiologist who still practices part-time — brushed aside any suggestion that he is not qualified to serve on the data board.
“I have a Master of Health Science degree from the Hopkins school of public health, which involves training in biostatistics (that’s a matter of public record, which you probably already knew),” he said. “I have been an investigator on numerous NIH grants and published numerous papers that involved complex statistical analysis, and have been involved in clinical research studies as a principal investigator.”
The congressman said that he plans to report the NeuroRx position on his next annual ethics filing, which is due in May, and that he does not interact with FDA as part of his data board service. He did not respond to a question about whether he had sought advice from the House Ethics Committee on the NeuroRx role before he had accepted it.