Rep. Andy Harris (R-Md.) is overseeing the trial for a drug to potentially treat COVID-19 after denouncing wearing masks and stay-at-home orders, Politico reported on Thursday.
Harris, a medical doctor, took on the unpaid job of joining the data and safety monitoring committee for a drug trial handled by NeuroRx, whose CEO and founder Jonathan Javitt has connections to the representative.
The Maryland Republican serves as one of three members of the committee, which is responsible for overseeing the safety and effectiveness of the drug, aviptadil, throughout the trial that started in May. The committee is also able to stop the trials should problems arise.
NeuroRx and Relief Therapeutics, which holds the patent on aviptadil, officially announced the congressman’s membership on the committee in July.
The five-term congressman’s membership on the board is unusual, as former Food and Drug Administration (FDA) Commissioner Scott Gottlieb told Politico he hadn’t heard of a member of Congress sitting on such a committee for any drug.
But because it is unpaid and he doesn’t — and hasn’t — owned a stake in the company, Harris does not appear to be breaking House ethics rules.
Several bioethicists expressed concerns to Politico about Harris’s membership on the committee, including about his alleged lack of experience in looking at drug trial data and about his ties to Javitt, which some feared could influence decision making if trial issues arise.
Harris defended his membership in a statement obtained by The Hill, saying, “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).”
“I have been an investigator on numerous [National Institutes of Health] NIH grants and published numerous papers that involved complex statistical analysis, and have been involved in clinical research studies as a principal investigator,” he added.
The Republican said he plans to report his participation on the committee in the next ethics filing due in May 2021 and does not work with the FDA as part of the committee.
“My only hope was to volunteer my expertise to help America find our way out of this pandemic, as every American who has a skill set to offer hopefully should be willing to do,” he said.
Javitt and Harris met more than 20 years ago when both were working at Johns Hopkins University, and Javitt donated $2,000 to Harris’s 2010 congressional campaign, according to Politico.
The NeuroRx CEO told the news outlet he chose Harris to sit on the committee because of his experience in critical care settings, adding the FDA approved of the trial knowing the congressman was on the monitoring board.
The trial has launched at four places in the U.S., and the FDA has approved “fast track” status for the trial and an expanded access program for patients in certain cities and states. The data and safety monitoring committee decided in July to continue the trial, according to a release.