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Claim of bias in Texas abortion pill lawsuit overshadowed by bias in abortion pill studies

Posted in Abortion pill, Abortion pill lawsuit, ACOG, Alliance for Hippocratic Medicine, DANCO, Daniel Grossman with tags , , , , , , , , on April 15, 2023 by saynsumthn

By Carole Novielli |  Republished from Live Action News

The abortion industry has claimed that District Court Judge Matthew J. Kacsmaryk was “biased” in rendering his decision to overturn the Food and Drug Administration’s (FDA) approval of mifepristone (Mifeprex), known as the abortion pill. The judge, industry profiteers claim, also refused to consider hundreds of studies that they claim “prove” the abortion pill is safe.

But what ‘Big Abortion’ conveniently leaves out is the extraordinary bias of those studies.

“The U.S. District Court for the Northern District of Texas, Amarillo Division, issued its ruling Friday in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. In it, the court allowed the Biden administration seven days to seek review from appellate courts. Danco Laboratories, the pharmaceutical company that manufactures chemical abortion drugs, also filed an emergency motion to stay at the 5th Circuit Monday,” Alliance Defending Freedom (ADF), which represented the plaintiffs in the case, wrote.

An emergency motion was also filed with the U.S. Court of Appeals for the 5th Circuit by the U.S. Department of Justice (DOJ) asking the appeals court to stay a federal district court’s ruling.

Bias in abortion pill studies

Live Action News has documented multiple times:

  • Clinical trial sponsors were pro-abortion, many funded by abortion pill investors.
  • Clinical trial locations were pro-abortion, funded by abortion philanthropists and some by abortion pill investors.
  • Abortion pill studies often funded by pro-abortion philanthropists, some who were also abortion pill investors.
  • Abortion pill studies were often published in pro-abortion journals.
  • Multiple authors of abortion pill studies were on the payroll of Danco or GBP, with some in leadership of organizations that were funded by Danco.

The abortion industry points to the American College of Obstetricians and Gynecologists (ACOG) to confirm the veracity of their studies, but ACOG is stridently pro-abortion and is funded by radical abortion organizations, including Ibis Reproductive Health (funded by U.S. abortion pill manufacturer Danco Laboratories) and by the David and Lucile Packard Foundation, a Danco investor.

The ACOG recently received $1.4 million from the Susan Thompson Buffett Foundation (Warren Buffett) — funder of many pro-abortion efforts worldwide — and has received hundreds of thousands from the foundation every year for several years. The Buffett Foundation was also one of the first investors in Danco. ACOG itself has funded the Bixby Center for Global Reproductive Health, where abortionists are trained.

The fact is that, not only was the FDA extremely secretive in their review of studies around the abortion pill but they are alleged to have hidden the names of the researchers who reviewed them for the FDA.

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Eliminating ‘adverse event’ reports doesn’t translate to low adverse events

Big Abortion is also claiming that Judge Kacsmaryk ignored studies which they say concluded that the abortion pill was safe. The pill, approved by the FDA for the termination of pregnancy, has already killed an estimated 5.6 million preborn babies (500K in 2020 alone) since approval in 2000.

Judge Kacsmaryk was clear in his 67-page opinion that not only did the plaintiffs have standing in this case (pp. 7-11, 11-13), but plaintiffs’ alleged injuries are concrete and redressable (pp. 13-17) and within the statutory zone of interests (pp. 16-18).

In addition, Kacsmaryk wrote that the “FDA relied on FDA Adverse Event Reporting System data despite the agency’s 2016 decision to eliminate the requirement for abortionists to report non-fatal ‘adverse events.’ Defendants maintain that ‘Plaintiffs offer no explanation for why it was impermissible to rely on the reported data. (pp. 38-39)’”

Abortion pill lawsuit from Texas on complication reporting

FDA changes in 2016 permanently removed REMS safety system requirements that abortion pill manufacturers Danco or GenBioPro (GBP) report all adverse events of which they were aware. Instead, the FDA changed the required reporting to deaths only. And since there has never been a federal requirement that abortion complications be reported, complications of which Danco and GBP were unaware would likely have gone unreported.

Contributing to the underreporting of complications, abortion insiders are advocating that women lie when presenting to medical facilities for abortion pill complications, instead claiming they are experiencing a natural miscarriage. In addition, some are even suggesting that ER doctors falsify documents regarding those complications. This further muddies any chance that accurate data on abortion pill complications will be known.

Judge Kacsmaryk seemed aware of these problems, writing, “The explanation should be obvious— it is circular and self-serving to practically eliminate an ‘adverse event’ reporting requirement and then point to a low number of ‘adverse events’ as a justification for removing even more restrictions than were already omitted in 2000 and 2016. In other words, it is a predetermined conclusion in search of non-data — a database designed to produce a null set.” (emphasis added)

‘Dangerous precedented’ for Court to interfere with FDA, except when pro-abortion plaintiffs do it

‘Big Abortion’ and its media allies have also claimed it is a “dangerous precedent” for the Texas District Court to “interfere” with an FDA decision over a drug. And while the dishonest pro-abortion media co-sign this claim, they fail to point out that in a competing lawsuit, filed by pro-abortion politicians in the state of Washington, the plaintiffs requested that the judge remove the drug from the FDA’s REMS safety system.

The lawsuit, filed against the FDA despite previously granting the abortion industry nearly everything it asked for, was co-led by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum. It was filed in U.S. District Court for the Eastern District of Washington. Nevada, Delaware, Arizona, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan and Rhode Island also joined the lawsuit.

“This case is about whether it is improper and discriminatory for FDA to relegate mifepristone — a medication that has been used over 5 million times with very low rates of complications, very high rates of efficacy, and which is critical to the reproductive rights of the Plaintiff States’ residents, as well as visitors who travel to the Plaintiff States to seek abortion care — to the very limited class of dangerous drugs that are subject to a REMS,” pro-abortion politicians wrote in their lawsuit (emphasis added).

“… [B]ecause there is no medical or scientific basis for restricting access to this safe and effective medication via the REMS, FDA’s decision to impose the REMS is arbitrary and capricious… The 2023 REMS restrictions are not supported by science. Mifepristone is safe and effective, and there is no reasoned scientific basis for subjecting it to additional burdens that are not applied to other, riskier medications….” the Washington State abortion pill lawsuit also stated. “For the foregoing reasons, the Plaintiff States respectfully request that this Court enter an order protecting access to mifepristone by preliminarily enjoining FDA from (1) enforcing or applying the 2023 REMS, and (2) taking any action to remove mifepristone from the market or otherwise cause the drug to become less available…” (emphasis added)

In other words, pro-abortion politicians petitioned the court to “interfere” with FDA decisions, requesting that the court force the FDA to remove the abortion pill mifepristone (Mifeprex) from the REMS safety regulation system which has been kept there under multiple pro-abortion administrations.

Judge Rice’s preliminary injunction v. Judge Kacsmaryk’s ruling against FDA decision

U.S. District Judge Thomas O. Rice was appointed to the Eastern District of Washington in 2011 by President Barack Obama, and according to CNN “previously sided with an abortion rights group. In 2018, he issued a permanent injunction that blocked the Trump administration from stopping grants to a Planned Parenthood program that funded teen pregnancy prevention programs around the country.”

While Rice has not ruled on all requests in the lawsuit against the FDA’s REMS, he did grant a preliminary injunction to bar the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”

At National Review Online, Ed Whelan, Distinguished Senior Fellow of the Ethics and Public Policy Center, broke down the rival federal district court rulings. “My initial read is that the rulings don’t conflict and that the Texas ruling would instead render the Washington ruling irrelevant…” he wrote. Whelan elaborated further on the Washington State case, writing, “On a quick skim, I’m confused by the lawsuit and the ruling (what do the plaintiff states under Democratic leadership fear that Biden’s FDA might do? is there any real disagreement, or is this a sham suit?), so I will leave it to interested readers to sort out.”

Whelan highlighted Judge Kacsmaryk’s ruling in the Texas lawsuit: “Plaintiffs are likely to succeed on their challenges to the FDA’s pre-2021 actions (pp. 39-60). The FDA’s 2000 approval violated Subpart H (pp. 39-48), and its pre-2021 actions were arbitrary and capricious (pp. 49-60).” And “Plaintiffs face a substantial threat of irreparable harm (pp. 61-63), and a preliminary injunction would serve the public interest (pp. 63-65).”

Live Action News is following these decisions and will update as new information becomes available.