Questions Sent to FDA and ABR on Humanized Mice Contract; FDA Statement

By Terence P. Jeffrey | August 7, 2018 | 10:38 AM EDT

On July 17, 2018, CNSNews.com sent twenty questions to the Food and Drug Administration and Advanced Bioscience Resources about the contract cited in the FDA’s June 13 presolicitation notice. On July 24, 2018, the FDA responded to CNSNews.com with a statement. After the FDA signed a contract with ABR on July 25, 2018, the FDA confirmed to CNSNews.com that that contract was the same one cited in its June 13 presolicitation notice.

Below are the questions CNSNews.com sent to the FDA on July 17 and the statement that the FDA provided on July 24:

Questions

1-Has the FDA finalized this contract with Advanced Bioscience Resources to acquire fresh “human fetal tissue” from aborted babies for “implantation into severely immune-compromised mice”?

2—If the FDA has not finalized this contract with Advanced Bioscience Resources has it finalized it with another contractor? If so, who is that contractor?

3—Under this federal contract, how much will Advanced Bioscience Resources (or another contractor) be remunerated for providing the FDA with fresh “human fetal tissue” for implantation into mice?

4-What is the total number of donor babies who are expected to donate their tissue to the FDA—through Advanced Bioscience Resources (or another contractor)—during the year-long duration of this contract?

5—Given that the contract specifically requires “fresh” human fetal tissue, does a technician (who is working for or coordinating with the FDA’s contractor) need to be present at the site of the abortion at the time of the abortion to harvest and process the tissues to guarantee their freshness?

6-Does the FDA need to know that an abortion is taking place that will produce fresh human fetal tissue for this contract so that FDA researchers can be prepared to implant that fresh tissue into mice in a timely manner?

7—A group of researchers at the NIH’s Rocky Mountain Laboratories published an article (https://www.ncbi.nlm.nih.gov/pubmed/24769067) in the May 2014 edition of The Journal of Immunological Methods that described a type of “humanized mouse” they had created that has a “functional human immune system.” In this article, the NIH researchers indicated that they created these humanized mice using liver, thymus and bone marrow taken from babies at 17 to 22 gestational weeks. The article also indicated that Advanced Bioscience Resources had provided these NIH researchers with this fetal tissue. A July 21, 2017 article in Therapeutic Innovation & Regulatory Science written by six FDA researchers (http://journals.sagepub.com/doi/full/10.1177/2168479017720249) describes a program conducted by the FDA’s Division of Applied Regulatory Science (DARS) that creates a similar “humanized mouse” with a human immune system. Figure 3 in this journal article is headlined: “Making a Mouse with a Human Immune System.” The caption says: “DARS utilizes advanced ‘humanized’ mouse models to improve drug safety assessment. These models optimized in DARS laboratories, provide enhanced predictive ability for human immune and liver responses to drugs…” The illustration in the figure shows how human thymus, liver and stem cells derived from human liver are implanted in a “severely immune-compromised mouse” to create “a mouse with a ‘humanized’ immune system.’”

Does this FDA contract for human fetal tissue to create mice with human immune systems—like the mice described in the Journal of Immunological Methods article written by NIH researchers--also require that the aborted babies whose tissue is used to create these mice must be 17 to 22 weeks in gestational age?

8-What is the youngest gestational age an aborted baby can be to provide tissue that can be used to create the humanized mice envisioned by this contract? What is the oldest gestational age?

9—The May 2014 Journal of Immunological Methods article (https://www.ncbi.nlm.nih.gov/pubmed/24769067) said that the federal researchers using human fetal tissue to create the humanized mice with human immune systems described in that article “routinely produced cohorts of approximately 40 TKO-BLT mice from a single tissue donor.” How many humanized mice with human immune systems will be created with tissue from a single donor in the research that will be supported by this FDA contract to acquire fresh human fetal tissue?

10—Given that the FDA will need fresh human fetal tissue to create the humanized mice described in this contract presolicitation are there any methods of abortion that cannot be used to terminate the baby who donates this tissue because that method of abortion would cause the tissue to be damaged or spoiled in a way that makes it unsuitable for this research?

11-What methods of abortion will be used and what methods of abortion will not be used on the unborn babies who provide their fresh tissue for use in this FDA research?

15—Advanced Biosciences Resources is located in California and the FDA is located in Maryland. Given that the FDA contract requires “fresh human tissues” to create humanized mice, in what state or states will the abortions that provide these tissues be performed? In what state will the FDA use these tissues to create its humanized mice?

16-How will these “fresh human tissues” be transported from the site of the abortion to the location where the FDA uses them to create its humanized mice?

17—How much time can elapse between an abortion that yields “fresh human tissue” and the use of this tissue by the FDA to create its humanized mice?

18—How many different abortion facilities will conduct abortions that provide this tissue to the FDA?

19—Will Planned Parenthood clinics conduct any of the abortions that provide the “fresh human tissue” acquired by the FDA under this contract to create these mice?

20—Are the mothers who agree to donate the tissue from their unborn babies for this FDA research informed that tissue taken from their aborted baby will be transplanted into a mouse?

 

FDA Statement

"The U.S. Food and Drug Administration is committed to ensuring that its research is conducted responsibly, conforms with all legal requirements, and meets the highest ethical standards. At the FDA, research involving human fetal tissue accounts for a very small fraction of the FDA’s total research and has been used in situations where it is critical to understanding how the human immune system responds to certain drugs and biologics. This work has led to a better understanding of a number of conditions and diseases that affect millions of Americans.

"The FDA’s researchers obtain fetal tissue from a non-profit Tissue Procurement Organization (TPO) that have provided assurances that they are in compliance with all applicable legal requirements, including relevant provisions relating to research involving human fetal tissue. FDA is not involved in the TPO’s sourcing of the tissue.

"In addition, the FDA has in place systems to ensure FDA research using fetal tissue, as well as any research funded by FDA, is in compliance with applicable federal, state and local regulations and guidelines, as well as FDA policies."

 

 


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