The Trump government has challenged a multi-million dollar research contract to test new treatments HIV-based fetal tissue – work targeted by anti-abortion lawmakers and social conservatives ,
The turmoil surrounding the contract of the National Institutes of Health with the University of California at San Francisco is part of a struggle between conservative adversary research using fetal tissue and scientists who say the material is for the development of new treatments for AIDS-related diseases Parkinson's vital.
The UCSF research lab and affiliated institute have been involved in testing virtually all HIV therapies, which have subsequently been approved by the US Food and Food Drug Administration since the 1990s, and the NIH provides all support for this work ,
Last week, a NIH contract The official in charge told the UCSF investigator that the government had ended the seven-year contract in the middle and that the decision came from the "highest levels," a virologist familiar with the events. Five days later, the university received a letter from the AIDS department of the National Institute for Allergy and Infectious Diseases of the NIH, in which it said the government would continue the contract for 90 days rather than the expected one-year extension. according to a person with knowledge of the letter.
The sudden uncertainty surrounding the future of the laboratory has broken out when federal health authorities re-examine whether the government should change its support for fetal tissue research "in the light of serious and ethical considerations," as announced in the September announcement Review said.
In recent weeks, representatives of the Department of Health and Human Services have held meetings with patient representatives, scientific societies, ethicists, and leading anti-abortion protesters to hear their views. HHS officials insist they have not yet made a decision, and just say publicly that they want to expand alternatives.
"This is a pro-life-for-science administration," wrote HHS Deputy Health Secretary Brett Giroir in mid-November Rep. Mark Meadows (RN.C.), chairman of the House's Conservative Freedom Caucus.
Since President Trump's inauguration, conservative congressmen and anti-abortion activists have put pressure on the government to end government support for fetal tissue research. They claim that in such studies what they call "body parts" are used by "unborn babies" and that alternatives exist.
The tissue comes from elective abortions. Researchers say its use has not led to an increase in the prevalence of abortions and has driven scientific progress that would otherwise have been impossible.
Irving Weissman, a pioneer in stem cell research at Stanford University, explained the research method he used, the UCSF lab is absolutely essential. There is no substitute today.
The UCSF research was a particular target of the wrath of the opponents. Several dozen lawmakers recently signed a letter urging the government to cut funding. In recent weeks, a columnist for the conservative website CNSNews.com repeatedly wrote that the administration did not terminate the contract. The board of the company's parent company, the Media Research Center, includes the conservative Rebekah Mercer, the leader of a family Super PAC who has put money in Trump's choice.
The UCSF Treaty is the second pot of the Federal Conservative Fund Crusade. In September, the Food and Drug Administration ended a small $ 16,000 contract with a California-based non-profit company, Advanced Bioscience Resources, for fetal tissue that was to be implanted in mice to study the immune response of drugs.
The UCSF contract is slightly more than $ 2 million a year should expire on Wednesday. The virologist, who was familiar with the events, said a contract official from the NIH's AIDS department gave a preliminary announcement to the lead researcher in early October that the government would extend the contract that started in 2013 for next year. Government officials confirm that this has happened.
However, the reports differ with respect to the next event.
According to the virologist, the chief investigator was told in a telephone conversation with an employee of the NIH last Wednesday that the AIDS department is acting at its sole discretion to terminate the contract. A university spokeswoman, who spoke on condition of anonymity because she was not authorized to discuss the matter, confirmed that the university had been informed last week that the contract would not be renewed.
The virologist said the NIH employee said it was not an NIH internal decision "and said the decision was" top-level ". The clerk, an official representative of the contract, also said that the work of the UCSF in the AIDS department is being supported and that the staff spent weeks answering questions about the contract, the virologist said.
Lawrence Tabak, deputy chief executive of NIH, said in an interview, "There was never any intention to show that we want to terminate the contract." After a meeting with contract agents, he said, "I have no indication that such a call has been made."
Tobacco and HHS spokeswoman Caitlin Oakley both said the future of the contract will remain uncertain until management closes the review
"No final decision has yet been made," said Oakley.
Nonetheless, the lead investigator is preparing to close down the lab, according to the person familiar with Monday's letter from NIH The Washington Post does not identify the investigator involved in HIV research since the mid-1990s, and investigators and university colleagues in AIDS research have been exposed to demonization and occasional threats to their work over the years.
Although the letter promises federal money until March 5, parts of it sound like instructions for an o Proper closure of a research company. The letter instructs the investigator to "complete on-going trials as planned", not to produce new animals for trials, and later to be willing to return animals and equipment to the government's lab when requested.
The contract supports full-time employment equivalent of six employees, and the university rules require a notice period of 60 days.
The lab is part of the Department of Experimental Medicine of the UCSF Department of Medicine. The government pays the lab to provide a central testing platform for assessing the efficacy and safety of chemical compounds in animals that appear promising for HIV prevention, treatment and cure from earlier stages of development by pharmaceutical companies and other academic researchers.
The lab carries out this test on so-called humanized mice. These are mice that start with a weakened immune system. Tissue from the thymus glands of broken fetuses is implanted in a capsule in the connective tissue under the kidneys of the mice. In four months, this tissue will grow into the equivalent of a human thymus gland, the site of the body that produces T cells that are depleted in humans – or in HIV-infected mice.
Using this animal model, the UCSF Laboratory – and the affiliated institute, which previously had similar funding from the NIH, evaluated more than 100 chemical compounds from five dozen classes of drugs.
In some cases, the tests discovered that substances that prevent or treat HIV in a test tube were promising were too toxic in animals. In other countries, the tests proved promising, for example, for a drug that is likely to block the infection for a year in which Merck Pharmaceuticals is developing.
When the administration stops UCSF's work, Stanfords Weissman said, "This is the case. , , Cutting off a line of research that has taken place in the past and is likely to be in the future [helpful] to solve the AIDS epidemic.
Lenny Bernstein and Alice Crites contributed to this report.