NCER Comments:
Both ongoing studies and limited clinical use show promising results for REGN-CoV2 therapy. No aborted fetal tissue was used in the creation of Regeneronʼs COVID-19 and no fetal tissue is contained in the therapy. Two sources of antibodies were used: human and mice. The company has filed for “expanded access” from the FDA, and an Executive Order will allow use of the therapeutic without cost to the patient. However, aborted fetal cells were used in the post-development, testing phase. This is unfortunate, because other sources of SARS-CoV-2-like particles could have been used. NCER will join with others in demanding more ethical means of testing in the future.
But the president’s repeated praise for the antibody cocktail he requested and received when he was first hospitalized nearly a week ago has generated controversy, given his clampdown on fetal tissue research at the urging of social conservatives crucial to his political base.
“It’s blatant hypocrisy,” said Lawrence Goldstein, a senior faculty member at the University of California at San Diego, who has used fetal tissue in his research.
“A lot of the opponents [of fetal tissue research] have looked the other way” when it comes to the cell line involved in both the Regeneron therapy and some of the coronavirus vaccines being developed, said Goldstein, who sits on a federal ethics advisory board created over the summer to review whether NIH should provide federal grants or contracts to researchers whose proposals were deemed scientifically deserving. The board recommended rejecting all but one of the 14 proposals.
Another advisory board member, David Prentice, vice president and research director of the antiabortion Charlotte Lozier Institute, said Trump’s use of the experimental cocktail does not raise ethical concerns. The reason, Prentice said, is because the fetal cell line was involved only in testing whether the antibody works in helping to defeat the virus, not in making the antibody itself.
“We would prefer they not use the controversial cell line even in the testing, because there are other alternatives,” Prentice said. “But that testing on the side doesn’t affect me in terms of the recipient of the drug.”
A White House official, speaking on the condition of anonymity because he was not authorized to discuss the matter, said that under NIH guidelines, “a product made using extant cells lines that existed before June 5, 2019 would not implicate the administration’s policy on the use of human fetal tissue from elective abortions.”
The controversy emerged after Trump appeared in a video released Wednesday evening on Twitter, standing in the sunlight outside the White House, praising the Regeneron therapy he inaccurately characterized as a cure for the virus. He said his diagnosis with the virus that has killed at least 211,000 people in the United States was a “blessing from God” because it allowed him to discover firsthand how the antibody cocktail left him feeling “great . . . like, perfect.”
In the video, Trump sounded like a pitchman for the experimental antibodies. “For me, I walked in, I didn’t feel good,” the president said of his arrival at Walter Reed National Military Medical Center after developing what his doctors have said was a high fever and a the first of two drops in his blood oxygen level. “A short 24 hours later, I was feeling great. I wanted to get out of the hospital. And that’s what I want for everybody. I want everybody to be given the same treatment as your president.”
Trump said he wanted the therapy to be available at no cost to patients. And getting ahead of the review that will be undertaken by the Food and Drug Administration, he said, “I have emergency use authorization all set.”
He made the statements shortly before Regeneron applied Wednesday night to the FDA for emergency authorization — a process more streamlined than a formal approval of a new drug — to use the cocktail for some covid-19 patients. According to a company spokeswoman, 2,000 people have participated in a final-stage trial, receiving either the cocktail or a placebo. Apart from those participants, the company has granted fewer than 10 people, including the president, special “compassionate use” permission to use the therapy, said the spokeswoman, Alexandra Bowie.
The therapy is based on a mixture of two antibodies. One, from a genetically modified mouse, and another from the blood of patients recovered from covid-19, are manufactured in ovary cells from a hamster, Bowie said.
Their effectiveness, she said, is tested by creating a “pseudovirus” mimicking the actual one. One element of the pretend virus is a cell line known as HEK293T that is an adaptation made at Stanford University in the 1980s of an original cell line made from human fetal tissue in the Netherlands in the 1970s.
The HEK293T cells are commonplace in biomedical research. “I bet every freezer in my building has a sample of these cells,” Goldstein said. “It would be disastrous to stop using these cell lines that were generated a long time ago.”
A 2016 article published in the journal Critical Reviews in Biotechnology that explored the history of use of human cell lines in biopharmaceutical manufacturing noted that the same cell line, HEK293T, had led at that point to five therapies approved by the FDA, including to treat hemophilia and Type-2 diabetes.
Even the Roman Catholic church, which is vigorously opposed to abortion, has issued documents carving out certain circumstances in which therapies or vaccines based on what it has called “cell lines of illicit origin” are permitted. A 2008 church document, Dignitas Personae, said, “Grave reasons may be morally proportionate to justify the use of such biological material,” as long as those who accept such treatment or inoculations make clear that they disagree with their origin and press for alternatives.
But in April, the United States Conference of Catholic Bishops and a score of antiabortion groups sent a letter to the FDA saying, “We are aware that, among the dozens of vaccines currently in development, some are being produced using old cell lines that were created from the cells of aborted babies.” The letter asked the FDA to “encourage and incentivize pharmaceutical companies to use only ethical cell lines or processes for producing vaccines.”
Prentice and a Lozier colleague issued a statement this week that explained Regeneron’s antibody manufacturing process, based on the company’s public statements and published papers. “No human embryonic stem cells or human fetal tissue were used to produce the treatments President Trump received — period.”
The Lozier Institute statement did not mention that the company’s antibody testing involved old cell lines derived from long-ago fetal tissue, although Prentice discussed that testing in an interview.
Mary Alice Carter, senior adviser to Equity Forward, a watchdog group that monitors the influence of abortion opponents within the administration, said the use of old cell lines derived from fetal tissue opposed in the letter is parallel to Regeneron’s use of the material to test experimental antibodies against the virus.
Carter said that Trump “has politically sided with folks who want to see these cell lines no longer used for therapies but went ahead and received it himself.”
Irving Weissman, a leading stem cell researcher at Stanford University and outspoken opponent of the administration’s fetal tissue research restrictions, said that Trump “didn’t understand probably what would be lost from fetal tissue research in allowing the ban, and he was not hesitant to use the fruits of fetal tissue research.”
Weissman noted that Regeneron’s co-founder, George D. Yancopoulos, trained early in his career about the genetics of antibody formation in labs that were funded by NIH.
“He was allowed to take all of that knowledge from NIH-sponsored research to develop something that is very, very important now,” Weissman said, pointing out that biotech companies’ discoveries typically grow from basic scientific advances that are federally supported.
“If you cut if off at the root,’ Weissman said, “then you cut off the fruit that develops from it.”