Things do NOT add up regarding the stated results and the cancellation of the ongoing testing. As typical, it takes time for questions to be answered. Here is an interesting article that may provide a "peek" into some questionable connections. Could this be about class action suits and sheltering people? Or is it stock manipulation? Is it a part of the ongoing bad blood between NRXP and RLFTF and those negotiations? This may take time to get to the bottom...
Mask skeptic lawmaker takes on side gig overseeing drug company trial Several bioethicists question Rep. Andy Harris' lack of experience.
Rep. Andy Harris Rep. Andy 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. | Al Drago/Pool via AP
By ZACHARY BRENNAN
09/17/2020 06:13 PM EDT
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.
null“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,” Harris said in his statement.
Harris met NeuroRx’s CEO, Javitt, more than two decades ago when they worked together at Johns Hopkins University. Javitt was then a surgeon, while Harris specialized in obstetric anesthesiology.
The two have kept in touch over the years. Javitt, who donated $2,000 to Harris’s campaign in 2010, said he’d visited Harris at his House office in recent years to discuss NeuroRx’s other drug in development, for suicidal bipolar depression.
Javitt — who is also vice chairman of the board of directors at Relief Therapeutics, which holds the patent on aviptadil — told POLITICO that he selected Harris for the data committee because of the congressman’s experience in critical care settings. Javitt also said that the FDA signed off on the trial knowing that Harris would be involved with the committee.
The aviptadil trial started in May at four U.S. sites, and aims to enroll more than 100 participants. The FDA has granted the drug “fast track” status, which is designed to speed the availability of drugs to treat serious diseases. NeuroRx is also offering aviptadil through an FDA-approved expanded access program for hospitalized patients at the same sites in Houston, Kentucky, Florida and California that are hosting the current trial.
The data board that Harris is part of has already made at least one crucial decision — recommending in July that the trial continue after analyzing preliminary data from 30 patients, Relief Therapeutics said in press release this week.
FDA’s guidance for data monitoring committees recommends that at least one member is a “biostatistician knowledgeable about statistical methods for clinical trials and sequential analysis of trial data.” But neither Harris nor the other two members of the NeuroRx panel fit that bill.
Alfred Sommer is the dean emeritus of the Johns Hopkins Bloomberg School of Public Health, with training in ophthalmology and epidemiology. Rita Colwell, an aquatic biologist, led the National Science Foundation under presidents Bill Clinton and George W. Bush. She now holds joint appointments at the University of Maryland and Johns Hopkins.
Colwell told POLITICO that she had served on data monitoring committees for other clinical trials. Sommer and Harris had never done so before joining the NeuroRx panel.
But all three of the NeuroRx panel members have professional or personal relationships with Javitt. Sommer, the chair of the data committee, worked with Javitt at Johns Hopkins; the pair have known each other for about 40 years. Javitt met Colwell during her tenure leading NSF, when he was a fellow at the non-profit Potomac Institute for Policy Studies providing support to the agency.
“It seems like a strange collection of people and when you think about the documents this committee would need to review — are they going to understand the adverse event reports? You want them to be informed enough to ask questions on if the adverse events are caused by the drug,” said Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics.
In some cases, the data monitoring board for a trial would be faced with deciding whether to stop that study. “You don’t want three well-intentioned friends being spoon-fed information from the trial and who can’t look at it critically,” Turner added.
Ellenberg -- who wrote the FDA guidelines for data monitoring committees while on staff at the agency -- echoed those concerns. “Neither Harris nor Colwell is known for clinical trials expertise,” she said. “Members of a DMC should all be very familiar with clinical trials.”
Javitt said that an outside biostatistician is working with the committee, but is not a member of it. He also downplayed the panel’s role in the trial. “Unless there are unexpected severe adverse events to take action on, the committee doesn’t have much to do,” he said.
Asked specifically about the unusual decision to include a sitting member of Congress on the data monitoring board, Javitt said it shows Harris’ commitment to fighting the coronavirus and finding effective treatments.
Holly Fernandez-Lynch, an assistant professor of bioethics at the University of Pennsylvania’s Perelman School of Medicine, said there is no shortage of specialists in critical-care medicine who have the biostatistics skills to serve on a Covid-19 drug data monitoring committee.
“Other COVID drugs — and there are many under study — presumably have done so without going to members of Congress,” she said.
Walter Shaub, the former director of the Office of Government Ethics, said “it’s concerning” that Harris is involved with a company regulated by FDA, given his position on the House appropriations subcommittee that controls the agency’s purse. “FDA officials may feel nervous about holding the company to high standards if a member of their appropriations subcommittee is involved in the trial,” he said.
Still, Harris’s involvement with NeuroRx does not appear to violate House ethics rules.
“The only thing that’s prohibited is outside earned income,” said Richard Painter, the former chief ethics lawyer for President George W. Bush who is now a law professor at the University of Minnesota. “House ethics rules are pretty loosey goosey.”
Painter said that Harris should recuse himself from any bills targeted at NeuroRx, but not necessarily the pharmaceutical industry as a whole. He also said that the congressman should recuse himself “from any company involvement with the FDA,” including any interventions on NeuroRx’s behalf.
But Henry Greely, a law professor and chair of the steering committee of the Center for Biomedical Ethics at Stanford University, saw no obvious problems arising from Harris’s work with NeuroRx.
“It’s strange but I don’t think it’s an ethical issue unless Harris tries to use his influence with FDA on behalf of the company,” Greely said. “It would be a closer question for me if he were somehow generally advising the firm, but a [data monitoring board] has a pretty discrete and specific task.”
Market Data 
Markets 
AI
