California AG Sues to Prevent Pro-life Clinics from Claiming Abortion Pill Reversal Treatment is ‘Effective’ and Can ‘Reverse’ Abortions
September 22, 2023
California’s Attorney General Rob Bonta called a press conference yesterday to announce the filing of a lawsuit against two leading chains of clinics offering treatment to reverse chemical abortions before either of those organizations had even been served with the 30 page complaint. Both organizations only learned of the action when media representatives called them for a response.
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The lawsuit does not seek to halt the treatment, which is being used by other clinics in California and around the world, but rather to enjoin the two clinic chains from making what the AG asserts are “false” claims.
The press release from Bonta’s office states:
California Attorney General Rob Bonta today announced a lawsuit against Heartbeat International (HBI), a national anti-abortion group, and RealOptions Obria (RealOptions), a chain of five crisis pregnancy centers in Northern California. The lawsuit alleges that the two organizations used fraudulent and misleading claims to advertise an unproven and largely experimental procedure called “abortion pill reversal (APR)”. The procedure is touted by HBI and RealOptions as a safe and effective way to “reverse” a medication abortion — in reality, it has no credible scientific backing, and has potential risks for patients who undergo it. Given the lack of credible scientific evidence supporting APR’s safety and efficacy, it is crucial that pregnant patients are provided with accurate information before deciding whether to undergo this experimental procedure. Attorney General Bonta’s lawsuit, filed today in the Alameda County Superior Court, seeks to block HBI and RealOptions from falsely advertising APR as safe and effective.
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“Those who are struggling with the complex decision to get an abortion deserve support and trustworthy guidance — not lies and misinformation,” said Attorney General Bonta. “And let me be clear: the evidence shows that the vast majority of people do not regret their decision to have an abortion — more than 95% of patients who undergo an abortion later say they made the right decision. HBI and RealOptions took advantage of pregnant patients at a deeply vulnerable time in their lives, using false and misleading claims to lure them in and mislead them about a potentially risky procedure. We are launching today’s lawsuit to put a stop to their predatory and unlawful behavior. I urge any Californian seeking information related to reproductive care to visit our Reproductive Rights website, which lists programs and resources that can provide the accurate, timely, and reliable help they need.”
Medication abortion typically uses a combination of two drugs — mifepristone and misoprostol — taken within 24 to 48 hours of each other to terminate a pregnancy. Advocates of APR falsely claim that if a pregnant person takes high doses of the hormone progesterone within 72 hours of taking the first drug, mifepristone, it will safely and effectively cancel the effects of the mifepristone.
There is absolutely no scientific basis to support such a claim. While medication abortion has been proven by decades of research to be exceedingly safe and reliable, no credible research so far has supported the safety or efficacy of APR. The first and only credible study that tried to test the safety and efficacy of APR had to be halted after three of its 12 participants experienced severe bleeding and had to be rushed by ambulance to the emergency room, raising questions about the risks of stopping a medication abortion midway and of APR. [emphasis added]
There are some seriously misleading claims made in the public relations release and in the complaint itself. The most important misinformation concerns the hemorrhages that halted the “first and only credible study” titled “Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial,” by Mitchell B. Creinin of U.C. Davis and four other co-authors. Its abstract can be found in the NIH’s National Library of Medicine PubMed site.
The study used the so-called “gold standard” double blind approach, which means that a control group was given a placebo and not administered the actual medication, while another group did receive the treatment. Neither the researchers nor subjects knew which participants were given the placebo. Advocates of abortion pill reversal (APR) consider this unethical, since all participants wished to reverse their chemical abortions, but subjects receiving the placebo were guaranteed a surgical abortion after two weeks if they had not already aborted.
The study was planned to have 40 women but was terminated after 12 participants. Two dropped out, and 3 did have hemorrhages, but what the PR release and complaint itself fail to disclose is that only one of those subjects experiencing hemorrhaging had received the treatment itself, and the other two were receiving placebos, in effect not being treated.
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The participant who received the progesterone treatment essentially completed her abortion by the time she reached the hospital and required no further treatment. However, the two in the placebo control group had much more serious consequences: one needed a transfusion and the other an emergency curettage.
In other words, the study demonstrated that the placebo – no treatment – was more unsafe than the treatment itself. The claims of the Attorney General are therefore misleading and constitute misinformation.
As for the claims of no “credible” studies, the first study, a report of six patients undergoing abortion pill reversal (APR), was published in 2012 in Annals of Pharmacotherapy, showing that four out of six babies survived. Subsequently, a review of 547 patients in 2018 was published and found that overall the babies‘ survival rate of this procedure was 48%. With the best methods, survival improved to 64%-68%.
As for the claim that large doses of progesterone used in APR were not safe, the American Society for Reproductive Medicine refutes this.
Importantly, and ignored by the California Attorney General’s office, the United Kingdom has already adjudicated abortion pill reversal and found it permissible. Dr. Dermot Kearney there began providing this treatment and faced intense opposition from abortion providers and the Royal College of OBGYN. The General Medical Council (GMC) targeted him. His medical practice was restricted, and he was prohibited from providing APR.
Dr. Kearney took his case to the High Court, asserting these restrictions were unnecessary and that APR was efficacious and safe. In Court, the expert witness turned out to be supportive of Dr. Kearney’s work and stated that there was an evidence base for APR. Dr Kearney’s patients were overwhelmingly supportive. In 2022, the case against Dr Kearney was dropped.
A recent review of the entire literature on APR both pro and con concluded, “mifepristone antagonization with progesterone to avert medication abortion is a safe and effective treatment.” The author stated that based on available information, physicians have a legal obligation to disclose this treatment to women about to undergo medical abortion.
As for the claim that most women do not regret their abortions, Heartbeat International states that 4,000 unborn lives have been saved and there are now 1,300 providers in 86 countries offering abortion pill reversal.
AG Bonta’s lawsuit will impose a huge burden of legal fees on the two clinic organizations to defend against, even if they are finally vindicated in court.
A 10- to 12-week-old baby in utero
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