Rewire.News recently sat down with Dr. George Delgado, a California physician and medical director of Culture of Life Family Services, for a rare interview.

The interview took place after he’d taught a class on abortion pill “reversal” at a conference hosted by Heartbeat International, which runs a network of crisis pregnancy centers, or fake clinics. The abortion pill “reversal” course is approved for California nursing continuing-ed credit, as Rewire.News has reported, despite criticism from medical organizations that warn abortion pill “reversal” is “unproven and unethical.”

Delgado and his associates this month published a larger case series on abortion pill “reversal” in Issues in Law and Medicine, a journal with anti-choice ties. An earlier case series had included only six patients. The new case series followed 754 patients between 2012 to 2016 who called a “reversal” hotline.

Each of the women included in the new study took mifepristone, the first of two drugs required for a medication abortion, but hadn’t yet taken the second drug, misoprostol. Abortion pill “reversal” involves administering the pregnancy hormone progesterone, either orally, vaginally, or by injection, to counteract mifepristone. Of the 547 patients administered progesterone within 72 hours of taking mifepristone who remained in the study, 257 reported live births. The overall “reversal” rate was 48 percent, reaching a rate of 64 percent among those receiving progesterone shots, according to the case series.

Critics point to flaws in the new case series. Dr. Daniel Grossman, director of the research group Advancing New Standards in Reproductive Health, told the Washington Post that mifepristone on its own “is not a very effective abortion-causing” drug. His research has found a 25 percent chance of a pregnancy continuing after mifepristone alone, he told the Post. Dr. Barbara Levy, vice president for health policy for the American College of Obstetricians and Gynecologists, said in Newsweek, “In medicine, we will use a case series like this to help inform good research. But we wouldn’t call this research.”

Dr. Delgado and supporters of abortion pill “reversal” say more than 450 women are expecting or have given birth after being administered progesterone, showing the protocol is safe and effective. Rewire.News asked Dr. Delgado to describe the steps in abortion pill “reversal,” including the consent process, and asked whether he’d submitted the case series to other publications, and what’s on the horizon for “reversal.”

The interview has been edited for clarity and length.

Rewire.News: Can you describe the steps of the abortion pill “reversal” process the way that you would explain it someone who calls the hotline or is going into a pregnancy center. What are the words you would say? How would you describe it?

Dr. Delgado: If a woman were interested in finding out more about abortion pill reversal, I would tell her that the medication that she has taken or will take called mifepristone or RU-486 blocks the effects of progesterone, and progesterone is a hormone that is very essential for the health of the pregnancy. Without progesterone, every woman would probably miscarry when they were pregnant. And if she has taken mifepristone and she has changed her mind, then we give supplemental progesterone so that there is more of the hormone around to out-compete the mifepristone at the receptor level, so that the mifepristone does not have the effect of blocking the progesterone. Once the misoprostol washes out of the system then the progesterone later can be discontinued.

Rewire.News: I guess my question is: Do you say this is a treatment, do you say this is a trial, do you say this is an experiment?

Dr. Delgado: The abortion pill “reversal” process is what I would characterize as a novel but not an experimental treatment. Novel because it’s still relatively new; but not experimental because now we’ve had experience with hundreds of women who’ve had successful reversals, where we’ve shown that it’s both safe and effective.

Rewire.News: So what is the consent process? You mentioned in class that there is a consent form and then there’s also something acknowledging they are going to be followed-up with as part of research. What does the consent form discuss?

Dr. Delgado: For women who find their doctors through the abortion pill reversal network, we recommend two consent forms, and they both go along with what’s called an informed consent process. Informed consent means they were informed, they’re told of their options, and then they give permission or consent so that they’re making a choice that’s based on knowledge.

And we think that’s extremely important because we don’t want anybody to make any kind of decision based on coercion or based on a lack of knowledge. So one of the forms that goes along with this explanation process—and the explanation is both verbal and written—tells them that they will be getting progesterone, which is a hormone that their own body produces. The hormone they get by mouth or by injection is bimolecularly identical, what we call bioidentical, to what their own body is making, and that progesterone use in pregnancy is considered to be very safe. We’ve had an over 50-year history of using it in pregnancy. And they are informed that this treatment to reverse the effects of the mifepristone is novel, that it’s relatively new, but that do we do have a large experience using it now. That’s the first consent, the consent to treatment.

The second is if they agree for us to track them, track their data. They don’t have to agree to that to get treatment. But if they do, then they sign this and it says that we will follow them, and we will contact them to find out how they’re doing. We will get information from their treating physician or clinic, and we will treat that information with the utmost confidentiality. When we start to do data analysis, we take their names out of it. So it’s what we call de-identified data. So they are sure that their information won’t be shared with anybody else.

Rewire.News: So they don’t have to agree to the research part of that, necessarily? They don’t have to agree to any kind of research? I’m going to skip down to where there was a sample of 112 women in the case series where their contact information was lost. But that’s different than what you’re talking about, the ones who say, “You know I really want to try this, but I don’t want you to follow me as part of research.”

Dr. Delgado: You’re referring to some of the women in our study who lost contact. That means they had agreed to be followed by us, but then when we tried to call them back, we couldn’t find them, couldn’t get in contact with them, and we didn’t know what happened to them.

Rewire.News: I’m going to shift to the new study. So you were talking about how sometimes progesterone is taken orally, sometimes it’s injected. What accounts for the difference?

Dr. Delgado: We’ve kind of built on the previous experience, which was sometimes doctors give it orally, sometimes by injection, sometimes they give it vaginally. And we also gave doctors the option to use whatever they thought was best, or whatever was their standard practice. Then looking at all the groups we did data analysis to try to discover which of those modes of delivery of the progesterone work the best.

Rewire.News: Some states are making abortion “reversal” part of the informed consent process, and I think there’s also more publicity around abortion pill “reversal.” Do you think that that has influenced the number of women who are seeking out abortion pill “reversal”?

Dr. Delgado: I think that more women are seeking abortion pill “reversal” because of the increased awareness, and that increased awareness is probably multifactorial. I think there’s a certain word of mouth that more people are hearing about it, telling their friends, who tell their friends. I think it’s becoming more prevalent on social media. We’re seeing more media stories about it, just like the story that you’re doing right now, so more people will be aware. I think that we’re also reaching out to more doctors, and more doctors, emergency departments, and clinics are aware of this.

Rewire.News: You have critics as you know. Dr. Daniel Grossman is one of your main critics, major critics. He spoke to my co-worker Teddy Wilson. I’d like to read what he said if that’s OK, so you have a chance to respond. Here’s the quote. “This goes a big step further by telling the women about a treatment that is not proven and really pushing them into participating in an unmonitored research project.” Do you want to respond to that, I mean are women informed? Are they being pushed into participating?

Dr. Delgado: No one is pushed into participating at all. Women come to us, they find us, they call us, they seek out the “reversal” treatment. When they do, we try to help them and connect them with a doctor who can treat them. It’s their choice. Absolutely. No one is coerced. No one is forced to do anything.

As far as the research part, again, they’re given that option. They sign a consent to allow it, they don’t have to do that. So that’s just an option. No one at all is being coerced or forced in any way. Now what I would say also is that when you have a condition where there’s a woman who desperately wants to stop the medical abortion, and there’s no alternative treatment, and we are offering a treatment that we have proven to be safe and effective, with this last study especially, then why wouldn’t we want to offer that to these women?

Rewire.News: I just want to push back a minute though, because it hasn’t been proven. I mean it was a case series. So it suggests that yes, there is this thing that’s happening, but you know with research you can’t prove …

Dr. Delgado: What does it take to prove then?

Rewire.News: Well it would probably take a study or at least several studies of the kind that you said that you don’t want to do, where when people come into this, they either are going to have a placebo or the treatment. And that way you could compare groups …

Dr. Delgado: …So let’s say.

Rewire.News: But even that wouldn’t be proof…

Dr. Delgado: … Let’s say you had a heart attack, right. Yes. If you had a heart attack and the people in this room went to do CPR on you. What if I told him, “Stop, don’t do CPR. There is no randomized controlled placebo trial proving that CPR works.” Would you want me to do that? I don’t think so. You would want me to do CPR right away because you know that there’s no better treatment when somebody has a heart attack outside of a hospital and their heart stops. And that’s the best way to start it. Wouldn’t it be unethical to put you in a placebo controlled trial to mark you and say, “You’re the one who did not get CPR.” We would just put our hands on your chest and not push in. Wouldn’t that be unethical, to let you die?

Same thing with these women who want reversal .… It would be unethical and unfair to those women who were assigned to the placebo group. And just because we don’t yet have a randomized controlled trial doesn’t mean that the study we’ve done now is valueless. It has a lot of value. The next study of course will be more powerful and we’re planning that, but until we get to there, since we don’t have another alternative treatment, then for sure we should go with this trial, which shows safety and effectiveness.

Rewire.News: So tell me about this next study, the one you’re planning.

Dr. Delgado: Sure. We’re planning a randomized controlled trial where we compared the different doses and modes of administration of progesterone to see which of the protocols works the best.

Rewire.News: When will this happen?

Dr. Delgado: This will happen in the next two years. Right now we are refining the study design and we are also seeking funding.

Rewire.News: I think it may have been in the Washington Post piece where you mention the case series was published in Issues in Law and Medicine because there was maybe a concern about the reception by other publications. Did you approach other journals?

Dr. Delgado: Well the thought was, you know, this obviously would be something for an obstetrics and gynecology journal. But with the very prejudicial comments that have been coming out in the press by Dr. Grossman and others, we didn’t think we would have a chance of getting a fair review. So rather than waste time and submit it to a journal like that, that would just delay it, we decided to bypass those journals.

Rewire.News: Looking forward, you talked about the study, but what does the future of abortion pill “reversal” look like? You mentioned in your class, “Our goal is saturation of the world.”

Dr. Delgado: How I see abortion pill “reversal” developing is I see that more doctors will come on board, especially when they read this study that we have just published. I see other regions in the world developing their own networks, like Europe and Latin America. And then I see it getting to the point where it becomes the standard of care … so that a woman who takes mifepristone and changes her mind can just call up her own doctor, or can go to the emergency department, and say, “I took mifepristone. I changed my mind. I want to ask questions and perhaps undergo reversal.”

Rewire.News: Could you see that happening in the next ten years, 20 years?

Dr. Delgado: I think so. I think certainly the next ten years we could definitely see that happening.

Rewire.News: Anything that you think I should have asked that I didn’t? Any other …

Dr. Delgado: … You might want to ask about birth defects …. In our case series of over 260 births … the rate of birth defects was equal to the general population. That indicates that abortion pill reversal does not increase the risk of birth defects.

Click here to read more reporting on abortion pill “reversal” via Rewire.News.