The Trump administration has ordered NIH scientists to stop acquiring new human fetal tissue for use in research experiments directly affecting three NIH laboratories' experiments.
Update: One of the labs that was restricted from using fetal tissue in their research under the Trump administration’s policy worked with the NIH to find another fetal tissue supplier. The NIH said the stoppage of fetal tissue to this lab had resulted as part of a miscommunication. The lab’s derailed HIV antibody experiment launched in January 2019 and is continuing to operate as of February 2019.
What happened: The Trump administration has ordered scientists employed by the National Institutes of Health (NIH) to stop acquiring new human fetal tissue for use in research experiments. The temporary ban was imposed in September 2018 without public announcement. Three NIH laboratories are directly affected by the ban and their experiments are likely to be, or have already been, disrupted by the ban.
Why it matters: This policy interferes with critical government research intended to safeguard public health and safety. Federal researchers are rightly concerned, as there are no alternatives that can fully replace the role that fetal tissue can play. Research using fetal tissue has led to medical breakthroughs that has saved the lives of millions of people. When government scientists are carrying out research that provides an undeniable benefit to society and follows the ethical guidelines set forth by federal law, officials should not ban aspects of the research for no other reason than that it is politically contentious.
The National Institutes of Health (NIH) and its parent agency the Department of Health and Human Services (HHS) have “instituted a pause” on the obtainment of human fetal tissues for research purposes at NIH laboratories, pending the outcome of a review that the HHS is undertaking on the topic. The ban does not have a firm end date and was not carried out due to any evidence of misconduct.
The ban impacts research labs conducting critical research on threats to public health. Three NIH labs, researching cancer immunotherapy, eye disease, or HIV/AIDS, are directly affected by the ban and two of the labs will run out of their supply of human fetal tissue by late January or late February 2019. An HIV research study, which was designed to test the effectiveness of an HIV antibody, was unable to start at all as a result of the ban.
There may have been efforts by the government to prevent this temporary ban from being widely known. The ban, instituted in September 2018, was never publicly announced by HHS or NIH. Government officials prohibited the affected researchers from discussing the ban. It was only when Science Insider obtained emails from a scientific collaborator of one of the affected labs that the NIH admitted that a “pause” was put in place. In the emails, a scientist, studying HIV at a lab affected by the ban, told his collaborator that the HHS “has directed me to discontinue procuring fetal tissue” and that “this effectively stops all of our research to discover a cure for HIV.”
Human fetal tissue plays a vital role in scientific research. Vaccine development since the 1930s have been dependent on the use of fetal tissue. Embryotic cells from the elective termination of two 1960s pregnancies are still grown today in laboratories to make vaccines for chickenpox, rubella, hepatitis A, shingles, and rabies. Clinical research is testing the use of fetal tissue for transplants, and as treatment options for Parkinson’s disease, Huntington’s disease, rheumatoid arthritis, cystic fibrosis, and hemophilia. Studying the fetal abnormalities that occur due to the Zika virus seems to require the use of fetal tissue. Sixty-four research, academic, and medical institutions wrote a letter to Congress to speak “on the behalf of millions of patients” who owe their health or their lives to fetal tissue research.
One of the most crucial uses of fetal tissue is their use in creating immune systems in mice that are similar to humans - these model organisms are known as “humanized mice.” Humanized mice are considered the “gold standard” model organism for studying the long-term effects of a drug or the progression of a disease. These model organisms are essential for studying how HIV affects human immune cells. According to Carrie Wolinetz, associate director for science policy at the NIH, there are no good alternatives currently available for developing human immune systems in mice without using human fetal tissue.
This is not the first time that the Trump administration has tried to restrict the use of fetal tissue in research. In late September 2018, HHS canceled a Food and Drug Administration (FDA) contract with the biomedical company Advanced Bioscience Resources, which the FDA previously called “the only company in the U. S. capable of supplying tissues suitable for [humanized mouse] research.” As a result, the HHS decided to conduct a “comprehensive review of all research involving fetal tissue.” In early December 2018, a University of California at San Francisco lab that specializes in the development of new HIV drugs was told by the HHS that its contract for work involving human fetal tissue will be extended for only 90 days instead of the usual 1 year.
Both agencies appear to be dismayed by the prospect of stopping vital scientific work as a result of the temporary ban. NIH officials told Time Magazine that “the intent was never to cause research to stop,” and an HHS spokesperson told STAT that “by no means was [the review] meant to halt or ban or cease research.” In December 2018, the NIH announced that it would allocate $20 million over the next two years to find alternatives to the use of fetal tissue in research. Adm. Brett P. Giroir, assistant secretary for health at HHS and one of the main officials pushing to limit the use of fetal tissue in government research, told scientists that, while government lab use of fetal tissue was being reviewed, non-governmental labs will not have a pause in their experiments if they adhere to ethical guidelines. NIH Director Francis Collins said that fetal tissue “will continue to be the mainstay,” and that “there is strong evidence that scientific benefits come from fetal tissue research, [which] can be done with [an] ethical framework.”
The HHS under the Trump administration has described its department as “pro-life, pro-science.” HHS appears to be trying to balance anti-abortion groups, whose advocacy helped prompt the HHS review, with scientists calling fetal tissue an essential component of medical, clinical, and biological research. It cannot be denied that barring NIH scientists from procuring fetal tissue is having a detrimental effect on government research. HIV researcher Warner Greene, a scientific collaborator of one of the affected NIH laboratories, described the situation as a “bombshell” being dropped and that even “if we were given the green light right now” to resume acquiring human fetal tissue, “it would probably take us a year to get back in the position we were in when the ban was put in place.” The ban has stalled or potentially stopped vital NIH research, and it has provoked uncertainty and alarm in researchers who require human fetal tissue in their experiments. This ultimately provides a disservice to the American people who have relied on fetal tissue research for their health, well-being, and in some cases their very lives.