Capitol Update: Clinical trials needed to put abortion ‘reversal’ pill debate to rest, says Rep. Lusk

Jay Senter - April 29, 2019 11:15 am
Rep. Nancy Lusk of Overland Park.

Each legislative session, we provide the Shawnee Mission area’s elected officials with the chance to share their thoughts about what’s happening in the state capitol. Rep. Brett Parker, Rep. Brandon Woodard and Sen. Pat Pettey are scheduled to send updates this week. Here’s Rep. Lusk’s filing:

Sometimes things can appear much differently on the surface than how they are if you take a deeper, more complete look. We legislators talk about the importance of “thoroughly vetting” the proposed bills that we see. It’s true – a complete understanding of the probable consequences of each bill is important because sometimes the declared intent by proponents can obscure what the actual effects will be if it becomes law. What first appears to be a bill’s main function may not represent the heart of what is at stake.

A case in point is HB 2274, known as the “abortion reversal bill.” It requires physicians to tell patients of a treatment that has not been scientifically proven to work. Governor Kelly has vetoed the bill and an override attempt in the House will likely be made after the legislature returns for the veto session on May 1. Although this issue is abortion-related, it doesn’t fall along the familiar fault lines of the usual pro-life and pro-choice debate divide.

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A false narrative is being promoted that the reason the governor and others, myself included, oppose the bill is to limit a woman’s freedom of information so that abortions cannot be stopped, but nothing could be further from the truth. We believe the more medical options and the more choice one has, the better. Something else is at stake. Something important – a patient’s right to make personal medical decisions based on information they can trust.

Background – What is a medical abortion?

The first thing to know is today many abortions are no longer performed surgically, but now are accomplished with a two-step pill process. Women up to 10 weeks pregnant seeking an abortion have the option of a medical abortion. The procedure is to take one pill of mifepristone that will block progestogen, a female hormone which helps to maintain a pregnancy, and a second pill, misoprostol, within six to 72 hours. This FDA-approved regimen has a success rate of 95-98% for ending pregnancies.

When only the first pill is taken, studies show as many as 43% of the women will still continue their pregnancies (according to the American College of Obstetricians and Gynecology). If the pregnancy continues, the first pill taken alone isn’t known to cause birth defects.

Dr. Delgado’s experiments

In 2012 a California family medicine physician, not an OB-GYN, had a theory that if a woman wished to stop an abortion after taking the first pill, it could be reversed by taking dosages of progesterone – in addition to not taking the second pill. Dr. Delgado tested his theory by administering a variety of experimental doses on patients, both orally and vaginally. He published a conclusion of his small case series and claimed that four out of six women were able to carry their pregnancies to term because of the dosages.

Despite the fact that Delgado’s alleged results were very close to what could be expected if a woman simply does not take the second medical abortion pill, and despite his not using a rigorous clinical trial approach and the very small number of test subjects, the idea of giving women an extra opportunity to reconsider having an abortion caught on. From that questionable first scant study, laws similar to Kansas’ proposed HB 2274 were inspired and passed in four states with mandates that doctors must counsel patients about the abortion “reversal” treatment.

Not too surprisingly, there was push-back by the obstetrician and gynecologist community. The American College of Obstetricians and Gynecologists criticized Dr. Delgado’s case series experiments as being “unproven and unethical” because it was not based on science, did not meet clinical standards, and the legislative mandates that it inspired intruded on the patient/physician relationship. A rigorous review of the medical literature on the abortion “reversal” method found that a woman’s chances of reversing an abortion were no better with progesterone treatment than without it.

I should note that the objection of the OB-GYN community was not because the physicians had a problem with the concept of allowing an option of reversing an abortion. The concern was that all medical treatments should be scientifically shown to be safe and effective before being practiced and the claim of this option has yet to be proven.

Next over a period of four years, Dr. Delgado experimented on dosage size and delivery methods (oral, vaginal, and injection) with 754 more patients who underwent his “abortion pill reversal” treatments. They were recruited from several unnamed countries and brought to the U.S. to be a part of his research that was unmonitored. It was not a clinical trial and he told his patients they were receiving a “novel treatment.” After the report was published in 2018, his test methods and claims were found to be flawed once again.

A review of Delgado’s work entitled, “Abortion ‘Reversal’ — Legislating without Evidence,” was published in The New England Journal of Medicine last October. The review determined the Delgado report’s data and results were difficult to compare, and likely exaggerated the treatment’s success. The scientific evidence needed to affirm that the progesterone dosages were responsible for the continuation of pregnancies was lacking. Dr. Delgado has also been criticized for not informing his patients they were a part of a research study, and for tracking and publishing their personal health history without their consent.

What HB 2274 mandates

Not only does the abortion “reversal” bill, HB 2274, force providers of services in any abortion facility to knowingly provide women with information that is medically inaccurate and possibly harmful to a woman’s health, there will be criminal penalties if they do not. A first conviction would find a physician to be guilty of a class A misdemeanor, and guilty of a felony upon a second conviction.

The bill would require a fine of $10,000 to any private office, hospital, or other clinic or facility that fails to post a notification sign about the “abortion pill reversal” treatment. Each day the required sign is not posted would be a separate violation.

The civil actions of the bill would allow the woman involved, the father, or any grandparent (in the case of the woman being under 18 or if the woman dies) to bring a lawsuit for damages against a physician who provided a medication abortion in violation of the provisions in the bill.

Those are some significant penalties for not giving advisement about a pill protocol that may do nothing and its safety is still undetermined.

Rep. Sydney Carlin from Manhattan, offered an amendment during the bill’s debate on the House floor to provide lifetime Medicaid coverage to any child born with birth defects as a result of the procedure and to any woman seriously harmed by it. However, supporters of the bill rejected this opportunity to demonstrate that their motivation was rooted in the best interest of women and babies, rather than in political posturing, and the amendment was defeated 81–42.

Clinical trials may potentially resolve the debate

Clinical trials are the gold standard of respected medical research. Quoting Dr. Mae Winchester an OB-GYN at the University of Kansas Medical Center, “In any other field of medicine, potential drugs and treatments must undergo rigorous and extensive randomized controlled trials to prevent undue harm to patients.” But progesterone has never been evaluated by the Food and Drug Administration for reversing an abortion.

Fortunately, there is at least one legitimate registered clinical trial being conducted at present. Mitchell Creinin, an OB-GYN professor at the University of California — Davis, is leading what could be the first source of scientifically sound data on the effectiveness of the abortion “reversal” concept, and the results are expected be published next year.

Daniel Grossman, an OB-GYN professor at the University of California — San Francisco, and a critic of Delgado’s improper methods, has acknowledged that the concept of the progesterone reversal process “is not what I would call a completely crazy idea”:

[Progesterone] “is administered for specific reasons and usually stopped late in the first trimester. It’s not commonly used the way they have been advocating for it for the so-called reversal treatment — where it’s started very early in pregnancy and continued all the way up until near term,” Grossman said. “I don’t have a lot of safety concerns, but I think we still need to collect data on this and prove for certain that it is a safe treatment.”

“That’s not the way medicine works — that we get a good idea and then we just start doing it and pass laws encouraging patients to use that treatment,” Grossman said. “Instead, every good idea actually needs to be tested, and we need to verify that the treatment is safe and effective. I’m really concerned that we’re going about this in a way that just runs contrary to the practice of medicine.”  [Topeka Capitol Journal, cjonline.com; April 22, 2019]

In other words, once the idea is no longer based on anecdotal evidence, but can be shown to pass the standard validation process that all other drug procedures must pass, the OB-GYN community will drop their objections. And then there will be no need for abortion “reversal” laws.

Respecting science and the physician/patient relationship

For those of us who oppose HB 2274, this is not a fight to deny women an option to reverse an abortion. We don’t want to do that. That would be limiting choice. The heart of what is at stake is a fight to protect our system of safeguards against medical quackery.

And in the instance of this legislation, we also need to protect our medical drug safeguard standards against good intentions that have gone awry. Here are my questions for my pro-life friends in the legislature.

  • What is wrong with thinking drugs and medical procedures should be proven safe based on scientific research?
  • Where is the legitimate data documentation that lives of babies were saved with Dr. Delgado’s regimen who would not have lived anyway? – that the extra progesterone dosages made the difference? Where is the proof that the treatment will not cause birth defects?
  • If their promised claim of the abortion “reversal” treatment is really true, it will hold up with testing. So why aren’t the bill’s proponents seeking scientific legitimization instead of fighting it?

Having our medical safety standard system based on science should be above politics regardless of where one stands on the pro-life/pro-choice debate. At best, this legislation is premature until clinical trials prove the protocol is safe. At worst it is “really about legislative quackery wrapped in a ‘pro-life’ package.

Lastly, in addition to respecting science, I think we should respect the private relationships between women and their medical providers. Great care should be taken before allowing Government to encroach upon such relationships and dictate how medicine should be practiced.

The right of choice depends on having genuine, not fake, options from which to choose. The abortion “reversal’ clinical trials cannot come too soon.

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