The Biden government on Friday lifted restrictions on the use of fetal tissue for medical research, and reversed the rules introduced by President Donald J. Trump in 2019.
The new rules, announced by the National Institutes of Health, allow scientists to use tissues derived from elective abortions to study and develop treatments for diseases such as diabetes, cancer, AIDS and Covid-19.
The Department of Health and Human Services, which oversees the NIH, has essentially restored the guidelines that were in place during the Obama administration. The NIH will “manage and supervise the research using human fetal tissue according to the policies and procedures that were in place” before the June 2019 ban, the agency said in an email statement on Saturday. The development was first reported by The Washington Post on Friday.
Scientists may buy fetal tissue from sources approved before the ban, and all projects approved before the Trump administration’s approval will be reinstated without further investigation, according to an email sent by scientists to the NIH .
“This is fantastic,” said Dr. Mike McCune, an HIV expert from the Bill & Melinda Gates Foundation and emeritus professor at the University of California, San Francisco, said. But he warned that it could take a while before research recovers.
Working with fetal tissue is a specialized skill and many scientists with the expertise have left the field, he said. “People with decades of experience had to get other jobs,” he said. “It all needs to be rebuilt to get it started again, but it will.”
The reversal of the ban fulfilled a promise by the Biden government to support science and violated conservative groups opposing fetal tissue research for violating the sanctity of life.
“The HHS decision to resume experiments on the body parts of aborted children contradicts the best ethics and the most promising science,” Tara Sander Lee, senior fellow and director of life sciences at the Charlotte Lozier Institute, said in a statement.
“The exploitation of the bodies of these young people is unnecessary and grotesque,” she said. “There are better and more ethical alternatives available.”
Human cells derived from a fetus years ago were used to develop the monoclonal antibody treatments that Mr. Trump was given after his Covid-19 diagnosis in October. And many of the coronavirus vaccines funded by Operation Warp Speed have also been tested in cells derived from fetal tissue.
Some scientists have rejected what they consider to be a double standard, saying that Mr. Trump did not have to take a treatment that was developed based on research he banned.
“It was just as hypocritical,” said Lawrence Goldstein, a neuroscientist at the University of California, San Diego, who used fetal tissue in his research.
Dr. Goldstein said he hopes any future Republican government does not ban Mr. Trump will not reinstate. “It would be awful if you went to a yo-yo,” he said. “It will die if it happens.”
Some conservative and religious organizations have suggested that scientists use tissue from spontaneous abortions rather than from choice methods. But spontaneous abortions are usually the result of genetic and developmental disorders that would render the fetal tissue unusable for research.
Scientists have been using fetal tissue for decades to create cell lines for life-saving research on vaccines and treatments for many diseases. Since the 1980s, so-called humanized mice containing human tissue or organs of the fetus have served as the hub for the development of treatments and the study of the immune response to pathogens such as the coronavirus.
Many drugs that have worked brilliantly in ordinary mice have failed in clinical trials on humans, said Dr. Goldstein noted. “Mice are not just small humans, so mice with humanized immune systems are very valuable.”
Fetal tissue is also used to study how human organs and systems develop in the womb. ‘This is the biology of young people; how do you do that by studying old people? “Dr. McCune said. “It just does not work.”
In June 2019, the Trump administration suddenly cut all funding for projects in government laboratories that rely on fetal tissue. The NIH also required academic scientists seeking federal funding to provide comprehensive justification for their need for human fetal tissue, and to compile an ethics board to review these proposals.
What you need to know about the vaccination of Johnson & Johnson in the USA
-
- On April 13, 2021, US health agencies called for an immediate halt to the use of the single-dose Covid-19 vaccine from Johnson & Johnson after six recipients in the United States had a rare disease within one to three weeks after vaccination. .
- Al 50 state, Washington DC and Puerto Rico has temporarily stopped or recommended the use of the vaccine. The U.S. military, federal vaccination sites and a number of private companies, including CVS, Walgreens, Rite Aid, Walmart and Publix, also suspended the injections.
- Less than one in a million Johnson & Johnson vaccinations are now being investigated. If there is indeed a risk of blood clots due to the vaccine – which has not yet been determined – the risk is very low. The risk of getting Covid-19 in the United States is much higher.
- The interruption could hamper the country’s vaccination efforts at a time when many states are facing an increase in new cases and trying to address vaccine hesitation.
- Johnson & Johnson has also decided to delay the explosion of its vaccine in Europe amid concerns over rare blood clots. South Africa, devastated by a more contagious virus variant that emerged there, has also suspended the use of the vaccine. Australia has announced it will not buy any doses.
HHS said in a statement at the time: “Promoting the dignity of human life from conception to natural death is one of the top priorities of President Trump’s administration.”
But the restrictions came down to a ban, which halted projects in their tracks and in some cases wasted years of effort. The ban, for example, halted research that in a small study increased the median survival of women with metastatic breast cancer from two years to ten years, Dr. Irving Weissman, a cancer expert at Stanford University who led the study, said.
In July, 90 scientific, medical and patient organizations signed a letter requesting the ethics council to allow fetal tissue to develop treatments for Covid-19 and other diseases.
“Fetal tissue has unique and valuable properties that often cannot be replaced by other cell types,” the statement said.
But in August, the board rejected all 14 proposals; the solitary approved proposal is based on previously acquired fetal tissue.
The following month, the House Committee on Oversight and Reform reported that the Trump administration’s ban was “based on ideological objections, not on evaluating the scientific merits of such projects.”
The NIH announcement of the new rules came a day after Xavier Becerra, the secretary of health and human services, said at a budget hearing on Capitol Hill that the agency would change the rules for fetal tissue research. Mr. Becerra did not disclose details, but his statement and the general embrace of the science of the Biden government indicated that the restrictions of the Trump era would be reversed.
“We believe we need to do the necessary research to make sure we include innovation and entrust all kinds of treatments and therapies to the American people,” he said. Becerra said during the trial.
The NIH said in its statement on Saturday that it would not set up another ethics advisory board “because the HHS secretary has determined that there are no new ethical issues that need special investigation.”
Scientists must still follow other rules for the research, including obtaining informed consent from the tissue donor. They cannot pay donors to obtain the tissue or to benefit from studies, the agency said, but otherwise they are free to resume research.
“These ethical guarantees and oversight are sufficient to prevent anything most people say is bad,” said Dr. Weissman said. “This is a welcome change.”