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HHS contradicts reports on fetal tissue research contract


HHS’s National Institutes of Health has made no decision on whether to extend a University of California, San Francisco contract for controversial research involving fetal tissue, said Caitlin Oakley, a spokeswoman for HHS.

Claire Doan, a spokeswoman for the University of California Office of the President, verified that the university “conducts research using fetal tissue that is vital to finding treatments and cures for a wide variety of adult and childhood diseases and medical conditions.”

According to the Post, an anonymous source said a National Institutes of Health official told a UCSF investigator that the decision to end a seven-year contract before its completion was coming from the “highest levels.”

“Unfortunately, the Washington Post chose to report assertions that are completely false,” Oakley said.

Oakley said that there were “no traceable records” proving these claims made by the Post’s anonymous source and that “multiple, on-the-record assurances from senior officials at both the National Institutes of Health and in the Office of the Secretary” told the Post that the claims were incorrect.

The Post also reported that a letter from the National Institute for Allergy and Infectious Diseases said the contract would continue for 90 days rather than the expected year-long renewal.

“No contracting official would have had the authority to impart any communication to UCSF that the contract was being cancelled because no decision has been made,” Oakley said.

Renate Myles, a spokeswoman for the NIH, said on Thursday that “NIH did, however, send a letter to UCSF to notify them of our intent to ensure continuity of service for 90 days while the audit continues and until a final decision is made on the contract.”

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Doan would not comment, though she said the “research is conducted in full compliance with federal and state law, as well as ethical standards.”

Oakley emphasized that “a decision will be made when the contract has been reviewed, pursuant to the ongoing audit/review process” initiated by the HHS in September.

The battle over human fetal tissue research

Two months ago, the HHS did terminate a contract: one struck between the Food and Drug Administration (an agency within the HHS) and a biotech company that was slated to provide about $16,000 of human fetal tissue for federal research.

The FDA explained in a notice posted online that “fresh human tissues are required” to create mice with human immune systems, which is necessary when testing drugs “for safety and efficacy.”
However, a response letter from more than 80 House Republications to the FDA called for the cancellation of this federal contract with Advanced Bioscience Resources Inc.

In September, the HHS not only terminated the contract, it stated that “in light of the serious regulatory, moral, and ethical considerations involved,” it had “initiated a comprehensive review of all research involving fetal tissue” while “continuing to review whether adequate alternatives exist to the use of human fetal tissue in HHS funded research.”

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Generally, fetal tissue is obtained through elective abortions and is used to develop cells that “mimic many of the properties that they have in a living body, and therefore can be used as a model for researchers,” according to a 2015 Congressional Research Service report.
The National Institutes of Health spends about $100 million a year on research involving human fetal tissue, government data shows. Yet for decades, those opposed to abortion have sought to prohibit using federal funds to support research using human fetal tissue.

Fetal tissue is used to make commonly used vaccines

“Since the 1930s, fetal tissue has been a critical component of biomedical science and breakthroughs that fundamentally changed the practice of medicine,” Doan said. She added that fetal tissue was used in the development of “the polio vaccine that saved hundreds of thousands of lives and merited the 1954 Nobel Prize for Medicine.”

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, explains in an educational video on the hospital’s website that five commonly used contemporary vaccines are made using fetal cells: rubella (German measles) vaccine, hepatitis A virus vaccine, varicella (chickenpox) vaccine, shingles vaccine and rabies vaccine, which is usually given to people bitten by animals that might transmit the rare disease.

Unlike bacteria, viruses on which vaccines are based cannot grow outside cells; they tend to grow better in human cells, and fetal cells are best, he noted.

“There were two elective abortions that were performed in the early 1960s. One was performed in England; the other was performed in Sweden. And those two elective abortions then created cells which have been used ever since,” according to Offit.

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Despite the usefulness of fetal cells when making vaccines, in 1988, HHS placed a moratorium on federal funding of research using human fetal tissue from elective abortions. Also that year, Congress passed an amendment (that President Ronald Reagan signed into law) to the National Organ Transplant Act that prohibited the transfer of human organs, including fetal organs and their subparts, for “valuable consideration, or payment.”
President Clinton lifted the moratorium in 1993, and Congress legalized funding for fetal tissue research that year.

Is human fetal tissue really necessary for medical research?

Kyle Orwig, an associate professor of obstetrics, gynecology and reproductive sciences, and molecular genetics and biochemistry at the University of Pittsburgh, said he thinks “human fetal tissue research is necessary.” Although many questions can be answered with cells in a Petri dish, “there is no way that stem cell technologies, organoid cultures or other techniques can model the complex and dynamic events” that occur during human fetal development.

“Other animal models, stem cells, organoids and other cutting edge technologies can provide important insights that reduce (but not eliminate) the requirement for human fetal tissues in research,” said Orwig, who spoke generally and did not address the possible National Institutes of Health contract dispute with UCSF.

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Without fetal tissue research, “scientists would be working in a vacuum subject to overinterpretation of data generated in a Petri dish,” he said, adding that this would have “dangerous implications” for human medicine.

Patricia Morris, a board member of the Federation of American Societies for Experimental Biology and a professor in the Reproductive Health Program at Rockefeller University, said human fetal tissue — specifically that derived from elective abortions — is “absolutely essential.”

“There is no substitute today,” said Morris, who also did not comment on the contract with UCSF. “No reproducible, robust and clinically relevant materials are otherwise available.” She added that the “materials obtained from spontaneous abortions” are not only “highly variable” but often contain “critical gene defects.”

A similar balancing of ethical and moral questions occurred during the decades of debate about research using stem cells derived from human embryos.
In 2001, President George W. Bush attempted a compromise when he introduced a ban on federal funding of research on newly created human embryonic stem cell lines yet allowed for continued funding of research on lines created prior to that date. Bush also publicly called for the use of alternatives. In 2009, President Barack Obama revoked these orders and allowed the National Institutes of Health to issue new criteria for stem cell research.

The hope for alternatives has been revived by the current administration. In its September statement, HHS concluded that it is continuing to review “whether adequate alternatives exist to the use of human fetal tissue” and “will ensure that efforts to develop such alternatives are funded and accelerated.”

CNN’s Gregory Wallace contributed to this article.

Clarification:
On Thursday, an NIH official confirmed to CNN that the agency had contacted UCSF about continuing its contract for 90 days.



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