Biden Administration Ends Restrict on Fetal Tissue Analysis

The Biden administration on Friday lifted restrictions on the use of fetal tissue for medical research and lifted the rules imposed by President Donald J. Trump in 2019.

The new rules, published by the National Institutes of Health, allow scientists to use tissues 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 guidelines in place during the Obama administration. The NIH will “manage and monitor research involving human fetal tissue in accordance with applicable policies and procedures,” ahead of the June 2019 ban, the agency said in a statement emailed Saturday. The development was first reported on Friday by the Washington Post.

Scientists can buy fetal tissue from sources approved prior to the ban, and any projects approved prior to Trump administration restrictions will be “resumed without further review,” according to an email sent to scientists by the NIH recorded “

“This is fantastic,” said Dr. Mike McCune, HIV expert at the Bill & Melinda Gates Foundation and Professor Emeritus at the University of California at San Francisco. However, he cautioned that it could take some time for the research to recover.

Working with fetal tissue is a specialty and many of the scientists with that expertise have left the field, he said. “People with decades of experience had to find other jobs,” he said. “All of that has to be restored in order for it to start again – but they will.”

The lifting of the ban fulfilled a promise by the Biden government to support science and dismayed conservative groups who oppose research on fetal tissue as a violation of the sanctity of life.

“HHS’s decision to resume experimentation on body parts of aborted children is contrary to both best ethics and most promising science,” said Tara Sander Lee, senior fellow and director of life sciences at the Charlotte Lozier Institute, in a statement.

“The exploitation of the bodies of these young people is unnecessary and grotesque,” she said. “There are superior and ethical alternatives.”

Human cells taken years ago from a fetus were used to develop the monoclonal antibody treatments given to Mr. Trump following his diagnosis of Covid-19 in October. Many of the coronavirus vaccines funded by Operation Warp Speed ​​have also been tested in cells derived from fetal tissue.

Some scholars criticized what they viewed as double standards, saying Mr Trump should not have taken treatment that was developed on the basis of research he had banned.

“It was just so hypocritical,” said Lawrence Goldstein, a neuroscientist at the University of California at San Diego who used fetal tissue in his research.

Dr. Goldstein said he hoped a future Republican administration would not reinstate Mr Trump’s ban. “It would be terrible for this research to be on a yo-yo,” he said. “It will die when that happens.”

Updated

April 17, 2021, 6:20 p.m. ET

Some conservative and religious organizations have suggested that scientists use tissues from spontaneous rather than elective abortions. However, spontaneous abortions often result from genetic and developmental disorders that would render the fetal tissue unusable for research.

Scientists have been using fetal tissue to create cell lines for life-saving research into vaccines and treatments for many diseases for decades. Since the 1980s, so-called humanized mice, which contain fetal human tissue or organs, have served as the linchpin for developing treatments and studying the immune response to pathogens such as the coronavirus.

Many drugs that had worked spectacularly well in normal mice failed in human clinical trials, noted Dr. Goldstein firmly. “Mice are not just tiny people, so mice with a humanized immune system are very valuable.”

Fetal tissue is also used to study how human organs and systems develop in the uterus. “It’s the biology of young people; How do you do that by studying old people? “Dr. McCune said. “It just doesn’t work.”

In June 2019, the Trump administration abruptly cut funding for government laboratory projects based on fetal tissue. The NIH also urged academic scientists seeking federal funding to fully substantiate their need for human fetal tissue and set up an ethics committee to review these suggestions.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of vaccination.
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HHS said in a statement at the time, “Promoting the dignity of human life from conception to natural death is a top priority for President Trump’s administration.”

However, the restrictions were a ban that held projects up and in some cases wasted years of effort. For example, the ban stopped research that had increased the median survival of women with metastatic breast cancer from two to ten years in a small study, said Dr. Irving Weissman, a Stanford University cancer expert who led the study.

In July, 90 scientific, medical and patient organizations signed a letter calling on the ethics committee to allow the use of 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.

In August, however, the board rejected all but one of 14 proposals. The only proposal approved was 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 an assessment of the scientific merit of such projects.”

The NIH’s announcement of the new rules came a day after Xavier Becerra, secretary for health and human services, stated at a budget hearing on Capitol Hill that the agency would change the rules for research on fetal tissue. Mr Becerra did not reveal any details, but his testimony and the general acceptance of science by the Biden administration suggested that Trump-era restrictions would be reversed.

“We believe we need to do the research that is needed to make sure we are innovating and bringing all of these types of treatments and therapies to the American people,” Becerra said at the hearing.

The NIH said in its statement on Saturday that it would not set up another ethics committee “because the HHS secretary has determined that there are no new ethical issues that need special review.”

Scientists must follow other rules for research, including obtaining informed consent from the tissue donor. They can’t pay donors to get the tissue or benefit from studies, the agency said, but they are otherwise free to resume the research.

“These ethical safeguards and oversights are enough to prevent anything most people would say from being outrageous,” said Dr. Weissman. “This is a welcome change.”

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