U.S. FDA investigates purchase of fetal organs, requires “fresh transport on wet ice”

Judicial Watch this week released more records of the U.S. Food and Drug Administration’s (FDA) purchase of fetal tissue for its “humanized mouse” program, showing that the organization spent large amounts of government money between 2011 and 2018 to purchase human fetal tissue from California-based Advanced Bioscience Resources ( ABR) from California between 2011 and 2018, claiming to require “fresh” fetuses shipped on “wet ice. These tissues were used to create “humanized mice” to test “biological drug products. (Humanized mice are mouse models in which human blood cells, lymphocytes or tissues are implanted into immunodeficient mice to rebuild their human immune systems.)

ABR is a nonprofit human fetal tissue “procurement” company that has been the subject of criminal investigations by committees in both the U.S. House and Senate investigating ABR’s trafficking in human fetal tissue and whether Planned Parenthood or any other entity has illegally profited from the transfer of organs harvested from aborted human fetuses.

U.S. federal law regulates the purchase and receipt of human fetal tissue for research purposes, and it is illegal to “acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.

This record is a disclosure obtained after the organization filed a Freedom of Information Act (FOIA) lawsuit against the U.S. Department of Health and Human Services (HHS) in March 2019. It includes the following correspondence between Perrin Larton, ABR procurement manager, and Dr. Kristina Howard, FDA veterinary research officer, between January 2011 and April 2018.

In an application sent to Larton on Sept. 27, 2012, Howard stated that ABR would pay $12,000 up front for “tissue procurement. Its contract provides for the supply of human fetal tissue from 16 to 24 weeks gestational age, including “a set of tissues (thymus/liver) approximately twice a month.” The tissues were to be “fresh and shipped on wet ice.

Howard’s May 10, 2012, email to Raton, titled “Tissue Delivery,” said, “Just wanted to follow up with you on the status of tissue delivery. We have three more batches of mice that need to be humanized, so please keep us on schedule each week until we manage to receive three sets of tissue.”

Howard’s Oct. 17, 2012, email to Raton about the sex of the aborted fetus from which the organs were removed: “I would like to check with your records about the sex of the tissue source we received today. It is liver #4505.” Laton replied, “The technicians cannot determine the sex. We only check the external genitalia, if not …… Due to the nature of the termination (abortion) procedure …… we have no way to tell.” Howard replied, “Thank you for explaining that to me. I have some leftover cells that can be processed for gender (screening) on it.”

In an email exchange dated May 9, 2013, Howard complained to Raton about FedEx’s x-raying of packages shipping fetal organs. Howard wrote, “Our package was x-rayed and the tissue is unusable.” Raton replied, “Damn …… They are great tissues. I procured them! I’m training a new tech in Minneapolis and I told her how important it is to put DO NOT X-RAY stickers on the packages. Of course, if you have a stupid person over at FedEx ….. But that’s a problem now.” Howard replied, “Yes, we are absolutely heartbroken. They were beautiful fetal tissues, and to lose them like that is just awful.”

In an August 26, 2015 email exchange, FDA’s Howard wrote, “As always, we are requesting liver and thymus for each date.” ABR’s Raton replied, “I will put the tissue delivery date you requested on the schedule.” Howard replied, “Thanks Perrin! Also, are you planning to attend the Humanized Mouse Symposium in Zurich in January?” Laton then wrote, “Yes, Linda and I will both be attending. Will we see you there?” Howard replied, “Assuming the government allows me to go, I’ll be there. I have lots of data!”

In an email exchange on June 9, 2016, Howard told Raton, “We have a very important, time-challenging, surgery the week of June 20. We will be making both double-derived BLT mice (human liver and BLT surgery).” Raton replied, “Does the tissue have to come from a male fetus? It really helps when we can send either one, especially since this is an important and time-sensitive surgery.” Howard replied, “We would strongly prefer to have a male fetus if at all possible. However, after we dose the mice, we have to continue with the procedure, so at this point, an undetermined sex or female is better than no tissue at all. I know in some cases it is impossible to determine the sex, however, I don’t know what percentage of your tissue falls into that category.”

A July 22, 2016, email in which Howard asked Raton if he knew “what the organization will be tomorrow?” Laton replied, “I worked with a doctor this week who miscarried a 20-week-old fetus. Other doctors in this practice don’t induce stillbirths until 22 weeks …… Of course …… This week we had four 21 week [sic] cases, all with digoxin injections on Wednesday, so the tissue was unavailable. I will let you choose first next week and prioritize your request.”

On August 5, 2016, an email from an unidentified person at ABR informed Howard that ABR was “unable to procure for you today,” referring to human fetal tissue. Howard replied, “Given the age of the mice (12 weeks), we will be using frozen tissue. Fresh tissue is always our first choice, but I don’t think we can wait another week. We will receive more mice in early September, so we will try to get more tissue at that time. I hope the supply issue will resolve itself at that time.” Raton, who was forwarded on the email (Ccd), responded, “This is so frustrating. We are also working with a new doctor at one of our busiest clinics …… Not a good combination! The organization that acquired it is horrible!”

A May 25, 2017 email in which Howard asked Laton “What are the chances we will get the tissue tomorrow?” Laton replied, “Quite possible. I don’t know how many cases there will be, but you are the only researcher who will be picking up tissue this Saturday.” Howard replied, “Good news! We have mice that need to be made.” Howard also thanked Perrin Raton, “By the way, the tissue last week was amazing!”

An email dated Sept. 22, 2017, in which Lutton wrote to Howard.” We did send you the tissue today. Is it going to be mailed to you so you can pick it up at the station?” Howard replied, “Yay! Glad to hear there’s tissue. By chance do you know how many weeks it is for?” Raton responded, “The organization is 15 weeks. Due to the Rosh Hashanah holiday …… The clinic was closed yesterday …… So there’s no real big organization today.” Howard replied, “I didn’t realize the holiday would affect the clinic’s operations. Thanks again for getting the organization.” Lutton replied, “We didn’t either …… But …… Many of the doctors are Jewish!”

In an email dated April 5, 2018, Howard wrote to Palin, “While we (like others) desperately need organization every week, this week and especially next week is important to us and we need to get it. We are trying to get several new staff members qualified for surgery (so they can attend other scheduled surgeries) and we have to have fresh organization to do that. I realize that tissue always comes and goes, but we would appreciate it if it could be a priority for us in these two weeks.” Laton replied, “I’m just letting everyone know that your request is a priority today, and if you don’t get it today, let’s talk about it tomorrow.”

In a June 18, 2018, email, Howard of the FDA asked ABR’s Perrin to bill the FDA for “four sets of tissue bills for July, however, to make sure they are stacked on top of existing purchase orders, is it possible to bill all of them on July 6 – as we did last year, as time is running out?” Palin replied, “I don’t believe there will be a problem with [name of person spoken to being redacted] because you have done that in the past.”

In September 2018, the U.S. Department of Health and Human Services (HHS) terminated its contract with ABR. HHS said it “did not provide sufficient assurance that the contract included appropriate protections applicable to fetal tissue research or met all other procurement requirements.”

Judicial Watch received these records as a result of a Freedom of Information Act (FOIA) lawsuit filed against HHS in March 2019, of which the FDA is a part (the case is Judicial Watch v. U.S. Department of Health and Human Services (No. 1:19-cv-00876)).

“These fetal organ trafficking documents shock the conscience and show the potentially illegal use of tax dollars to purchase organs from unborn fetuses killed through abortion,” said Judicial Watch President Tom Fitton.

Judicial Watch recently announced that the federal court overseeing the March 2019 lawsuit has ordered HHS to release previously withheld portions of its records regarding the purchase of organs from aborted human fetuses. The court found “reason to question” whether the transactions violated federal laws prohibiting the sale of fetal organs.

The court ruling noted that ABR: sold fetal livers, thymuses, brains, eyes, and lungs for hundreds of dollars. After deducting the cost of services such as transportation and cleaning, ABR was able to collect more than $2,000 for a fetus purchased from Planned Parenthood for $60. The federal government has been involved in this potentially illegal trade for years.

The court also found that the FOIA exception invoked by the government could be used “to conceal illegal and questionable business practices under the guise of ‘confidential business information,'” and declared that “there is reason to question the legality of the transactions between the government and ABR.

This is the third set of records released by Judicial Watch following the March 2019 lawsuit. Other sets of records, which also include those obtained from the National Institutes of Health, were released in February 2020 and June 2020, respectively.