In wake of Trumps fetal tissue clampdown scientists strain to adjust

first_img Sign up for our daily newsletter Get more great content like this delivered right to you! Country Many biomedical researchers were stunned, noting that the tissue, which would otherwise be discarded, has properties that make it valuable for research. It is less specialized than adult tissue, for instance, and readily adapts to new environments. “These new restrictions have no scientific or ethical basis and will roll back decades of consensus in the U.S., delaying the development of new treatments,” said Doug Melton, president of the International Society for Stem Cell Research in Skokie, Illinois, and co-director of the Harvard Stem Cell Institute.“The whole point here is to so wrap the research in red tape that it’s impossible or at least unlikely to be feasible for many researchers,” says bioethicist Alta Charo of the University of Wisconsin in Madison.A 1993 law formalized rules for using fetal tissue donated after elective abortions in U.S.-funded research. Last year, NIH spent $115 million on roughly 173 projects that rely on the tissue; about 160 were run by university scientists. One-third of the 173 grants focus on HIV/AIDS, many using humanized mice to probe, for example, how HIV hides out and evades the immune system, and what drugs might defeat it. Others tackle other infectious diseases, eye disease, and fetal development as well as toxic exposures during pregnancy.NIH says its scientists are conducting just three projects affected by the new rules; all will stop. “This decision is devastating. It effectively ends our studies looking into new approaches for an HIV cure,” says Warner Greene, director of the Gladstone Institutes Center for HIV Cure Research in San Francisco. Greene is a partner in one of the projects, run by retrovirologist Kim Hasenkrug of NIH’s Rocky Mountain Laboratories in Hamilton, Montana.At universities, the policy allows existing projects to continue until their current NIH funding expires. Nearly half of these extramural grants will expire within the next 18 months, and scientists will need to apply for a renewal if they want to keep the work going. Grantees are now grappling with what the new review process might mean.It has already caused at least one researcher to change course. HIV scientist Jerome Zack last week told colleagues at UC Los Angeles (UCLA) that he had decided to remove his work using fetal tissue to develop humanized mice from a renewal application, due at NIH in August, for a large grant supporting the university’s long-standing Center for AIDS Research. “The grant covers way more than mouse work, it covers all HIV research on campus,” he says. “I don’t want to jeopardize that.”Scott Kitchen, a Zack collaborator who directs mouse production at UCLA, says that in the past year his group provided humanized mice for more than 70 scientists on campus and nine at other institutions, as well as performing multiple large projects for several companies. “All of this has been critical in scientific and therapeutic development,” Kitchen says. “And all of it may now be derailed.”At Columbia, Sykes is worried about the one-third of her 15 staff who are funded through two NIH grants. She recently submitted a renewal proposal for one grant and planned to submit the other in July. HHS hasn’t said when the policy will kick in. But when Sykes asked NIH officials how it might affect her proposals, the response “wasn’t reassuring,” she says.Much could depend on whom the HHS secretary appoints to the ethics review boards. Under existing law governing HHS ethics boards, one-third to one-half of a board’s members must be scientists, and each must include at least one theologian, one ethicist, one physician, and one attorney. The law “absolutely” would allow HHS to pack the boards with members who oppose abortion, Charo says.Critics of the new policy also say it will undermine a goal of opponents of fetal tissue research: to find and encourage the use of alternatives. In December 2018, NIH Director Francis Collins noted that his agency was putting up to $20 million over 2 years into research on such alternatives. But scientists say that those alternatives need to be tested for validity against human fetal tissue itself. For the time being, Collins said in December 2018, fetal tissue would “continue to be the mainstay” for certain kinds of research.The new rules could remove that mainstay. But Charo notes a new president could reverse the policy, which is not codified in law. Michael DiVito In wake of Trump’s fetal tissue clampdown, scientists strain to adjust Country * Afghanistan Aland Islands Albania Algeria Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Cote d’Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People’s Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People’s Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Martinique Mauritania Mauritius Mayotte Mexico Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Norway Oman Pakistan Palestine Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Qatar Reunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Vietnam Virgin Islands, British Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Megan Sykes, an immunologist at Columbia University, has spent years using human fetal tissue to develop a mouse with a humanlike immune system, which mimics how type 1 diabetes develops in humans. The tissue is donated after elective abortions, and the mice are testbeds for potential diabetes treatments. But last week, she learned that President Donald Trump, acting on a priority of advocacy groups opposed to abortion, had issued a new policy that is likely to cause lengthy delays the next time she seeks U.S. government grants for her work—and could even choke off federal funding for all studies that use fetal tissue. The policy “is incredibly disappointing,” Sykes says, because it is a “politically motivated decree” that could derail numerous disease research efforts.The new Trump policy, issued 5 June after a 9-month review led by officials at the Department of Health and Human Services (HHS), has three major components. One kills a long-standing contract between the National Institutes of Health (NIH) in Bethesda, Maryland, and the University of California (UC), San Francisco, under which the university used fetal tissue to develop humanized mice for HIV drug testing. Another ends research using fetal tissue conducted by any scientist directly employed by NIH. The third and widest-reaching provision adds a lengthy and uncertain step to NIH’s process for awarding new or renewal grants to university scientists, such as Sykes, for studies that use human fetal tissue. It requires HHS to appoint a separate 14- to 20-member ethics advisory board to review each proposal that NIH reviewers have found worthy of funding. The review of up to 6 months will result in a funding recommendation to the HHS secretary, who can accept or reject the advice.Enacting the new policy “was the president’s decision …. to protect the dignity of human life,” Judd Deere, deputy White House press secretary, told Science. It was applauded by antiabortion activists, whose lobbying prompted HHS to launch its review of U.S.-funded fetal tissue research in September 2018. “This is a major pro-life victory,” said Marjorie Dannenfelser, president of the Susan B. Anthony List in Washington, D.C.center_img Renewals of two diabetes grants held by Megan Sykes (right) of Columbia University could be held up by a new federal policy scrutinizing fetal tissue research. Email Click to view the privacy policy. Required fields are indicated by an asterisk (*) By Meredith Wadman, Jocelyn KaiserJun. 11, 2019 , 3:00 PMlast_img read more