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  • 2018-12-11 (xsd:date)
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  • Did the Trump Administration’s Policies Halt a Research Project Seeking an HIV Cure? (en)
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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: 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: 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: 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 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: 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. (en)
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