But the president’s repeated praise for the antibody cocktail he requested and received when he was first admitted nearly a week ago generated controversy, given his crackdown on fetal tissue research at the urging of crucial social conservatives. its political base.
“It’s blatant hypocrisy,” said Lawrence Goldstein, a faculty member of the University of California at San Diego, who used fetal tissue in his research.
“Many opponents [of fetal tissue research] have looked the other way “when it comes to the cell line involved in both Regeneron therapy and some of the developing coronavirus vaccines, said Goldstein, who sits on a federal ethics advisory board created over the summer to check whether the NIH should provide federal grants or contracts to researchers whose proposals have been deemed scientifically worthy. The board recommended that all but one of the 1
Another advisory board member, David Prentice, vice president and director of research at the anti-abortion 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 only involved in testing whether the antibody works to help defeat the virus, not in making the antibody itself.
“We’d prefer they didn’t use the controversial cell line in testing as well, because there are other alternatives,” Prentice said. “But that test on the side doesn’t affect me in terms of the recipient of the drug.”
A White House official, speaking on condition of anonymity because he was not authorized to discuss the matter, said that according to NIH guidelines, “a product made using existing cell lines that existed prior to June 5, 2019 would not imply the policy of administration on the use of human fetal tissue resulting from elective abortions. “
The controversy emerged after Trump appeared in a video posted Wednesday night on Twitter, standing in sunlight outside the White House, praising the Regeneron therapy which loosely defined a cure for the virus. He said his diagnosis with the virus that 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 made him feel “great.” . . like, perfect. “
In the video, Trump sounded like a launcher for experimental antibodies. “For me, I walked in, I wasn’t feeling well,” the president said of his arrival at Walter Reed National Military Medical Center after developing what his doctors said was a high fever and the first of two drops in his blood. oxygen level. “24 hours later, I felt great. I wanted to get out of the hospital. And that’s what I want for everyone. I want everyone to be treated the same as your president. “
Trump said he wanted the therapy to be available for free to patients. And anticipating the review to be undertaken by the Food and Drug Administration, he said, “I have all clearances for emergency use.”
He released the statements just before Regeneron asked the FDA for emergency clearance Wednesday night – a more streamlined process than formal approval of a new drug – to use the cocktail for some covid-19 patients. According to a company spokesperson, 2,000 people participated in a final trial phase, receiving either the cocktail or a placebo. In addition to these participants, the company has granted fewer than 10 people, including the president, special “compassionate use” permission to use the therapy, spokeswoman Alexandra Bowie said.
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 produced in a hamster’s ovary cells, Bowie said.
Their effectiveness, he said, is being tested by creating a “pseudovirus” that mimics the real one. One element of the fake virus is a cell line known as HEK293T which 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.
HEK293T cells are common 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 the use of human cell lines in biopharmaceutical manufacturing found that the same cell line, HEK293T, had led by that point to five FDA-approved therapies, including the treatment of haemophilia and type 2 diabetes.
Even the Roman Catholic Church, which is firmly opposed to abortion, has issued documents that cut out some circumstances in which therapies or vaccines based on what it has called “cell lines of illicit origin” are allowed. A church document from 2008, Dignitas Personae, stated, “Serious reasons may be morally proportionate to justify the use of such biological material,” provided those who accept such treatment or vaccinations make it clear that they disagree with their origin. and press for alternatives.
But in April, the United States Conference of Catholic Bishops and some 20 anti-abortion groups sent a letter to the FDA saying, “We are aware that, of the dozen vaccines currently in development, some are being produced using old cell lines that they were created from the cells of aborted babies. “The letter asked the FDA to” encourage and incentivize drug companies to use only ethical cell lines or processes for vaccine production. “
Prentice and a colleague of Lozier’s released a statement this week explaining Regeneron’s antibody production process, based on the company’s public statements and published documents. “No human embryonic stem cells or human fetal tissue were used to produce the treatments received by President Trump – period.”
The Lozier Institute statement did not mention that the company’s antibody test involved old cell lines derived from fetal tissue a long time ago, although Prentice discussed this in an interview.
Mary Alice Carter, senior consultant at Equity Forward, a watchdog group that monitors the influence of abortion opponents within the administration, said the use of old cell lines derived from opposite fetal tissue in the letter parallels. Regeneron’s use of the material to test experimental antibodies against the virus.
Carter said Trump “sided politically with people who want to see these cell lines no longer used for therapy, but he went ahead and got it himself.”
Irving Weissman, a leading stem cell researcher at Stanford University and an outspoken opponent of the administration’s restrictions on fetal tissue research, said Trump “probably didn’t understand what fetal tissue research would be missing in allowing the ban. , and did not hesitate to use the fruits of research on fetal tissues “.
Weissman noted that Regeneron co-founder George D. Yancopoulos was trained early in his career on the genetics of antibody formation in NIH-funded laboratories.
“He was allowed to take all that knowledge from NIH-sponsored research to develop something that is very, very important now,” Weissman said, noting that biotech companies’ findings typically stem from federally supported basic science advances. .
“If you cut the root, ‘Weissman said,” then you cut the fruit that grows from it. “