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| - In September 2018, the U.S. Department of Health and Human Services (HHS) announced that they would be canceling a contract with a company called Advanced Bioscience Resources Inc. (ABR) to procure fetal tissue for federal medical research projects. The department alleged that they were not “sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.”
Using this development as pretext, HHS announced that they would additionally be conducting “a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved" -- in effect putting a “pause” on all research that relied on fetal tissue.
ABR supplied fetal tissue to two National Institutes of Health [NIH] laboratories, one of which uses the material to create what are known as humanized mice. In a broad sense, these mice have been bred, with the help of fetal human tissue, to express a human immune response, making them a cost-effective way to test the efficacy of immunotherapeutic drugs:
Such mice are particularly valuable for HIV drug testing in part because tissue from a single human fetus can readily generate a group of 40 to 50 genetically identical mice, and because the animals can, unlike monkeys, be infected with the human virus, HIV. Potential drugs can then be tested in such a group, with ample mice as controls, giving the studies robust statistical power.
ABR had been the supplier of fetal tissue to NIH’s Rocky Mountain Laboratories (RML) in Montana, which had been using humanized mice to test potential HIV therapies. In a grant report on that laboratory’s efforts to study HIV using humanized-mouse models during the 2016 fiscal year, NIH scientist Kim Hasenkrug indicated strong potential for their research methods to aid in the search for new treatments for HIV:
Experiments in FY2016 revealed that our ... humanized mouse model can be used in long-term studies (up to one year) with [Antiretroviral Therapy, ART] administered by injections or via an oral route (drugs incorporated into mouse chow). Such mice develop chronic and latent HIV infections. We have demonstrated that HIV viral loads in these mice can be suppressed to levels undetectable by highly sensitive PCR tests for viremia and provirus.
Warner Greene, the director of the Gladstone Center for HIV Cure Research in San Francisco, had been collaborating with RML to test potential antibody therapies on humanized mice, and he first told Science that the HHS “pause” on fetal tissue procurement meant that the researchers could not guarantee enough mice to complete a statistically robust study. In a phone call, he explained to us that:
What happened in September was that my NIH collaborator at the Rocky Mountain Laboratories [Kim Hasenkrug] was informed that he could no longer order fetal tissue from the sole source supplier, ABR, and so we [were told that we] could complete the [initial] experiment that [had already been set up], but in science you need to do multiple experiments. You can’t depend upon one experiment to see whether it’s repeatable, etc. So essentially this ban on fetal tissue stopped the line of investigation.
Speaking to Science, Greene said that “Hasenkrug had not yet launched the experiment, and [RML’s] supplies of existing mice were too small to conduct the repeated experiments required to reach convincing scientific conclusions.” In a 9 December 2018 statement provided to Science after the publication's original 7 December 2018 reporting, HHS acknowledged that they had (at least temporarily) blocked staff scientists from procuring fetal tissue, but that they did not think -- or realize -- such a move would have affected the study in question:
[In their statement, the NIH] said the agency in September “put a pause in place” for staff scientists procuring new human fetal tissue, “an action NIH thought was prudent given the examination of these procurements. Research with tissue already on hand could proceed, and NIH leaders asked to be notified by intramural investigators if new procurement would be necessary. NIH leadership was not informed that new procurement was necessary for the study you reference in your [7 December 2018 Science story]. We are looking into why this did not occur.”
In his interview with us, Greene stated that this explanation made no sense. “To my knowledge ... we were never made aware that we should approach the NIH to inform them of our need for more fetal tissue to complete this investigation.” If such a request were required, Greene said, he and his team would have “acted upon it in a millisecond.” We also reached out to the director of NIH’s National Institute of Allergy and Infectious Diseases (which oversees the Rocky Mountain Laboratory) for an update on the current status of the project and for clarification on the fetal tissue review’s impact on the study but have not received a response.
However, as HHS has acknowledged both that they “put a pause in place” on fetal tissue procurement, and that this pause resulted in the inability of a trial seeking an HIV cure to move forward, it is factual to state that the Trump administration’s policies shut down (at least temporarily) scientists’ efforts to find a cure for HIV. Greene told us that NIH has been extremely supportive of their work, and that he feels that this change is “clearly a policy that’s ... reflective of a new political situation in Washington, D.C., that’s now impacting our science.”
Greene is one of many who viewed the 24 September announcement regarding fetal tissue research as a proxy debate over abortion. Chronologically, the announcement that the federal government would cut ties with ABR followed a campaign by several anti-abortion groups who explicitly sought to have the government cancel its contract with ABR, as reported in Science:
On 11 September, 45 anti-abortion groups wrote to HHS Secretary Alex Azar that they were “shocked and dismayed” by the FDA contract [with ABR]. On 17 September, 85 members of Congress wrote a similar letter to FDA Commissioner Scott Gottlieb asking him to cancel the contract.
Reacting to HHS’s actions [on 24 September], Alta Charo, a professor of law and bioethics at the University of Wisconsin in Madison, said: “My instinct is that this is driven by politics, and is part of the overall effort to stigmatize and eventually criminalize abortion, as well as part of a larger campaign to roll back the clock on sexual and reproductive rights.”
Greene told us that after much internal debate, he and Hasenkrug plan on running that initial experiment anyway, with the hopes that the political climate will change in their favor come January 2019.
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