A series of contracts that began under the Obama-era Food and Drug Administration paid out almost $100,000 as part of efforts to obtain from a controversial vendor tissue from fetuses aborted in the first and second trimester for research into “humanized mice,” documents discovered in June reveal.
The details of the contracts, obtained in a lawsuit by government watchdog group Judicial Watch, are likely to play a role in key decisions made by a fetal tissue ethics advisory board convened by the Trump administration, one which The Washington Post said is “dominated by foes of abortion and fetal tissue research.”
The 165 pages of documents, which relate to the government’s deals with the nonprofit firm Advanced Bioscience Resources, reveal the program continued well into the Trump administration, although it was eventually terminated over concerns that it was not complying with federal law regarding the uses of fetal tissue.
In 2016, then-Senate Judiciary Committee Chairman Charles Grassley, an Iowa Republican, referred ABR for criminal prosecution as part of an investigation into fetal tissue sales.
“Since 2010, three companies — Advanced Bioscience Resources, Inc.; StemExpress, LLC; and Novogenix Laboratories, LLC (Novogenix has since gone out of business) — have paid affiliates of Planned Parenthood Federation of America to acquire aborted fetuses, and then sold the fetal tissue to their respective customers at substantially higher prices than their documented costs,” Grassley’s office said in a news release at the time.
The exchanges in the documents released this summer are typically clinical, as one might expect. Take this June 28, 2017 email between the FDA and ABR: “I am tasked with the purchase of tissues suitable for [humanized mice] research. I would like to request a quote. Please review the Statement of Work and quote your pricing as outlined.”
There’s a table for 16 samples each of “Human Fetal Tissue — Liver” and “Human Fetal Tissue — Thymus,” along with tests, shipping and delivery.
“The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is conducting a research program to evaluate the usefulness of humanized mice (HM) for regulatory purposes. The HM are created by surgical implantation of human tissue into mice that have multiple genetic mutations that block the development of the mouse immune system at a very early stage,” the statement of work said.
“The absence of the mouse immune system allows the human tissues to grow and develop into functional human tissues. As part of this process DARS needs to repeatedly acquire the proper type of tissues. In order for the humanization to proceed correctly we need to obtain fetal tissue with a specific set of specialized characteristics.”
The fetuses must be “Age range 16-24 weeks” and “Tissue must be fresh and never frozen,” the statement of work added.
In another email thread, which started July 14, 2017, a contracting specialist with the FDA told ABR that “In order to properly document pricing, I require some documentation of your prices as offered to the public” and requested either redacted invoices or “a place on your website that lists prices,” Judicial Watch pointed out.
“We do not have a website, and we don‘t allow ‘the public’ to request tissue. It is only sent to verified researchers who have applied and have been approved to receive tissue,” ABR responded.
“As we are not selling items, we do not have prices. We assess fees for our services. The only document provided then to qualified recipients would be our Fees For Services Schedule. [I’ve] attached another copy of our current Fee Schedule for your reference. We’re a small non-profit company, and the fees are the same for everyone.
“I hope this fulfills your requirement. We‘ve done business with the F.D.A. for many years and we‘ve not experienced such rigorous procedures for the production of purchase orders. Will this process be necessary for each P.O. created now?”
The “Fees For Services Schedule” included, among other things, “Fetal Cadaverous Specimen Procurement” with pricing for “2nd trimester specimen (13 – 24 weeks)” and “1st trimester specimen (8 – 12 weeks).”
On Sept. 24, 2018, the FDA informed ABR it was terminating a contract with the firm.
“[T]he Government is not sufficiently assured that the human tissue provided to the Government to humanize the immune systems of mice will comply with the prohibitions set forth under 42 U.S.C. § 289g-2,” the letter read, referencing U.S. Code that deals with “Prohibitions regarding human fetal tissue.”
“[T]he Government has concerns with the sufficiency of the sole-source justification.”
That came on the same day the Department of Health and Human Services said it was “conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations.”
The topic of “humanized mice” is an ethical minefield, considered deeply problematic for social conservatives and of little concern to liberals.
As The Post noted, humanized mice were developed in the 1980s, allowing mice to develop human-like immune systems and making them useful for medical trials.
In an Aug. 4 article, The Post’s Amy Goldstein reported that that despite the controversy, “federal funding of research using the material was permitted consistently after the early 1990s. In June 2019, however, Trump rewrote rules to limit such research; his aides were eager to point out the president made the decision over the objections of some of his top health-care advisers.
“For scientists who work directly for the government, the new policy ended federal funding of all fetal tissue research.
“For the many scientists in academia and other outside labs who rely on NIH funding, the rule change was subtler. Researchers could still apply for new or renewed grants and contracts. But if the proposals were deemed worth funding by NIH’s normal scientific reviews, projects submitted after late last September would face an extra hurdle: an ethics screening by a new advisory board, which would send its recommendations to Azar, who has the final say.”
The board, which BuzzFeed News reported met for the first time July 31, has been criticized for having too many pro-life voices on it. Of course, had it contained one pro-life voice, this still would have been too many.
Judicial Watch president Tom Fitton said the documents showed the ethically fraught nature of the programs.
“These documents are a horror show,” Fitton said in a news release. “These records show that the FDA was trafficking in human fetal parts. Incredibly, there continues to be a push to reopen these monstrous experiments!”
And thanks to a series of contracts that began under former President Barack Obama, we used taxpayer money for them. That’s something that should disgust conservatives — particularly when taxpayer money goes to problematic organizations like ABR.
They may have broken the laws of man. They definitely broke the law of God.
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