Why would a medical board want fewer safe and proven medical options, less informed consent for women?

Why would a medical board want fewer safe and proven medical options, less informed consent for women? (THIS IS ZUN/Pexels)

California is considering a rule change to their continuing education unit (CEU) guidelines for nurses that would exclude anything related to abortion pill reversal.

Nurses in many states must complete CEUs to keep their nursing license. The number and frequency can vary depending on the state. Heartbeat International has been licensed in the state of California since 2012 as a CEU provider. 

Since at least 2016, pro-choice activists have been trying to get Heartbeat’s license revoked or some of their CEUs rejected — namely, CEUs concerning abortion pill reversal and fetal pain. 

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Right now, California’s Board of Registered Nursing (BRN), the governing body which approves or denies provider licensing applications, is considering a rule change that would make abortion pill reversal a taboo subject for CEUs. This would force Heartbeat to stop offering courses to nurses that even touch on this life-saving process.

How would the new rules do this? 

Well, I’m here to give you the lowdown on the drawn-out history between pro-abortion outlet Rewire, Heartbeat International, and the State of California, as well as explain how this rule would hurt nurses and women needing help.

Timeline of the battle

In 2012, Heartbeat International became licensed in the state of CA to offer CEUs to nurses. 

Now, there is a bit of a gap in my knowledge of what led up to the brouhaha that exploded in 2016. But in January 2016, the very abortion-friendly newsgroup Rewire provided the CA BRN descriptions of HBI’s CEUs that involved abortion pill reversal information. The intent of sharing the information was to get the classes canceled, or even get Heartbeat’s license to provide CEUs taken away. Rewire was very dismissive of the science behind APR, citing only a single article available at the time, although the scientific reasoning is actually very strong, and was even back in 2016.

Rewire was also very concerned with CA’s process for approving CEUs. In short, CA’s BRN approves providers, not individual courses, a large number of providers who apply get approved, and they had performed no audits of providers in the last 2 years. That’s because, according to the chief of licensing and administrative services at BRN at the time, “because we don’t have the staff to conduct the audits.” The concern Rewire had is that there is not enough staffing or money to conduct quality control Rewire thinks the BRN should. This will be important to keep in mind later when I discuss the new rule and the additional workload it would entail.

In February 2016, then-CA senator Jerry Hill proposed legislation in direct response to Rewire’s information. The legislation would mean the classes offered would have to be based on generally accepted scientific principles (which APR is), and audits of providers would have to happen at least once every five years. Hill told Rewire that “BRN officials said the board would issue cease-and-desist letters” to HBI for the classes it currently offered containing APR information.

Rewire was trying to force the hand of the BRN for political reasons, based on the underlying assumptions that abortion is good, abortion is healthcare, and abortion pill reversal is junk science. They wanted the BRN and state law to reflect their pro-choice stances. Of course, all while stating that this issue should not be political. 

An audit was started for Heartbeat after this, and between January and November 2016, the back-and-forth between the CA BRN and Heartbeat started. Heartbeat did receive a cease-and-desist letter, but it was later rescinded because the BRN did not have the authority to issue it

In September 2016, Sen. Hill’s legislation passed (but did not go into effect right away). Amidst the ongoing audit, the license for Heartbeat International to offer CEUs was renewed. In October 2016, BRN asked for some points of clarification in the ongoing audit and in November that year, Heartbeat responded to follow-up questions in the audit. 

But 2017 was when the real fun began. 

In January 2017, Sen. Hill’s legislation went into effect. In August 2017, Heartbeat got the green light from the CA BRN on the APR courses. But just one month later, in September, HBI received another letter from the BRN telling them the APR courses did not meet the new standards and to cease and desist in offering those classes! However, it was revealed that someone at the CA BRN may have been leaking information ahead of time to Rewire since Heartbeat had not even received the letter at the time Rewire asked about it. 

In their August 2017 article, the Rewire author admits that a systematic literature review showed simply not taking the second medication in the abortion pill regimen can forestall the abortion. The explanation is meant to imply, Why do we need APR? It’s unproven. However, the better question is, Given that progesterone has been used for decades for miscarriage prevention, why not APR instead of just expectant management? 

Importantly, in October of that year, Governor Brown signed SB 799 into law. This law required the BRN to report their detailed comprehensive plan for approving/disapproving CEUs by January 2019 and required them to give a progress update in January 2020 on the implementation of the plan. The Senate analysis of the bill made it clear they thought CA BRN was being lax in its duties to field CEUs, letting courses that had “dubious scientific merit” get approved (political talk for letting APR courses be taught).

And in December 2017, the CA BRN again reversed their decision and approved Heartbeat’s APR courses after meeting with Heartbeat staff in an informal conference. This is when talk of revising the CEU regulations to exclude new and experimental treatments was mentioned to Rewire. Those talks were held in February 2018 and are currently what is putting the APR CEUs back in the hot spot for potentially being banned.

In their January 2018 article, Rewire pointed out that the BRN feared legal backlash if they did not approve the course, and that staff within the BRN feared the issue could go viral. Whatever the CA BRN does at this point, it is going to look bad. They have changed their minds too many times.

If they are confident the courses are not scientifically sound, what do they have to fear? It’s clear to anyone following the story that the BRN is just a political pawn for pro-choice groups to bully. They care more for politics and public sentiment than they claim to care about the scientific accuracy of the CEUs they approve.

In Spring 2018, one of the pioneering doctors of the APR process, Dr. Delgado, published a larger case study of 754 patients showing the reversal process was successful in over 60% of patients — a 2-3 times higher success rate than just not taking the second set of medication.

On April 12, 2021, the CA BRN proposed changes to the California Code of Regulations concerning nursing CEUs. On October 12, 2021, the CA BRN gave reasons for proposed changes: namely, legislative pressure. In this document, the BRN claims that subsequent proposed rules will have an outline to follow regarding the screening of CEUs. On November 1, 2021, the BRN gave notice of proposed changes

The proposed changes

The changes the CA BRN propose are: 

● The course content of CEUs may include “generally accepted experimental medical procedures or treatments.”

● The rules define “generally accepted” as “the efficacy of the procedure(s) or treatment(s) is supported by at least two peer-reviewed, publicly available scientific journals or studies, is published in medical and/or scientific literature, and is generally accepted as effective by the medical community.”

● The rules define “experimental” as “(1) for drugs, the treatment will be considered experimental if the United States Food and Drug Administration approved the drug for use, but the drug is used for a purpose other than that for which it was approved; or (2) any treatment or procedure for which peer-reviewed scientific journals or studies show that the procedure or treatment is the subject of on-going clinical trials.” 

On December 23, 2021, Danielle White, legal counsel for Heartbeat, sent a comment to the BRN explaining why the changes in regulations would be disastrous and discriminatory, which I have summarized and supplemented below.

Definitions much too broad, out of line

The definitions for “experimental medical procedures or treatments” and for “generally accepted” are much too broad to be of any use, and are completely out of line even with federal guidelines and medical practice at large.

You know what a drug used for a purpose other than the FDA approved it for is called? Off-label drug use. And it happens All. The. Time. My own doctors have prescribed medications in an off-label manner and were not at all concerned that they were doing something experimental or harmful to me. In fact, it’s commonly accepted that off-label drug use is not the same as “experimental or research use,” it is common for prescription medications, and is not illegal. 

Additionally, just because a drug is the subject of an on-going clinical trial does not mean it is experimental! Many medications are still the subject of clinical trials even after being approved by the FDA. That’s how medicine and science work — constantly improving and finding new applications and solutions. You know what is still in clinical trials? 135 currently open, ongoing clinical trials in the U.S. alone? Aspirin. Well, I guess aspirin is an experimental medical treatment now. The CA BRN better be ready to audit all CEUs that mention aspirin usage!

Let’s also keep in mind that the CA BRN is also framing “experimental” procedures and treatments as this big, bad thing they need to protect against. This is ridiculous. Another way of framing scary “experimental” treatments is to call them “cutting-edge,” “ground-breaking,” and “pioneering.” Is CA really ok with letting their nurses miss out on important new developments in medicine? Is that not part of the point of CEUs?

Besides all that nonsense, for “generally accepted,” the definition is repetitive yet still not clear. If a procedure or treatment is published in ‘two peer-reviewed, publicly available scientific journals or studies,” does that not automatically mean they are published in “medical and/or scientific literature”? Only one of these two statements should be needed. But also, the “generally accepted as effective by the medical community” is so vague as to open the door wide for discrimination. 

The rules are ripe for discriminatory use

And this brings us to the second big issue with these new rules. Not only are they vague and nonsensical, but they can be used to hide discrimination. None of the terms within that clause are defined, so the CA BRN could argue one way on a CEU using that clause, while the provider could argue their case just as strongly using that clause. It helps no one because it gives no clarity. It sounds good and "sciencey," but it offers no definitive guidelines; which means it also offers no recourse for providers of CEUs if the CA BRN says the course doesn’t meet the guidelines. How can you appeal to such vague guidelines?

These regulations really make no sense outside of the scope of an excuse to disallow APR education, because the off-target effects are too broad to be something the BRN should be ok with. They are potentially sacrificing education in a lot of other areas just to try to exclude information on this one process. Again, it is clear the BRN is not motivated by science here, but by pressure from pro-choice organizations and politicians. 

Tweet This: Since at least 2016 pro-abortion activists have been trying quash Heartbeat International’s continuing education units for nurses

The CA BRN mentioned only 50 CEU providers would have to have their classes audited, and no additional staffing would be necessary to undertake this, with only a modest budget increase expected. How do they know which providers to audit if this new rule says all CEU courses must now meet specific standards? Would this not mean that all new courses would have to be looked over and approved before being accepted, and all current courses would need to be audited?

They would need a mechanism in place for course content to be submitted, a process in place to review all such content before approval, and a way to let providers know which CEUs met the requirements and which did not. It would also be nice if they gave feedback on why courses did not meet approval. Additionally, they would need to figure out how to do all this for not only new CEUs offered, but current ones being offered. 

I’m a generally optimistic person, but I’m not that optimistic. These new requirements are going to take much more time to implement and to carry out going forward, which may require more staffing, and definitely a budget increase for putting new processes in place for this shift from auditing providers to CEUs. How are they going to get the money and manpower? According to Rewire, they were short-staffed even before COVID-19 hit and were not well-off financially. How are they going to take on all this auditing? I don’t buy their optimistic outlook.

What now?

Proposed rule changes have to go through a review process before and after public comments are given, and this process takes time. It can be up to 6 months or longer after public comments have been submitted to implement the rule change if it gets approved. 

So, at some point this summer or fall, it is possible these overly broad and vague rules would go into effect. And if that happens, Heartbeat and other life-affirming organizations which seek to train nurses to be prepared to help women who have changed their minds about abortion will be targeted. If this happens, what will Heartbeat do?

Danielle White, legal counsel for Heartbeat International, replied, 

“We are confident that our APR courses are both based on sound biological and medical principles and relevant to the practice of nursing. There is no legitimate reason why an APR course should be rejected by the Board of Nursing. But since the regulation, as currently drafted, is wrought with both procedural and substantive deficiencies, it leaves the Continuing Education program open to substantial abuse through discriminatory rejections of applications. Heartbeat must continue to educate the very healthcare professionals who need to know about abortion pill reversal - nurses. Nurses need to have knowledge about the availability of APR and the mechanisms involved in the protocol. This is especially true, given that the abortion pill is being made more broadly available than ever. Informed healthcare is the best healthcare. Heartbeat will take appropriate actions to protect its ability to educate nurses on the life-saving APR protocol.”

Christa Brown, BSN, RN, and director of Medical Impact at Heartbeat International, also responded, saying, 

“We know that regret is common after abortion and thousands of women have now attempted reversal of mifepristone. That number will continue to increase with more availability of chemical abortion, and it is important that nurses know how to respond to these increasing requests for care. APR is an evidenced-based process developed by physicians and is proven to be safe and effective for both moms and babies.”

With more than half of abortions now being pill abortions, and with an increasing lack of oversight by medical professionals (which we have seen lead to dire consequences for women), the fact that APR will be needed more than ever is an unfortunate truth. The APR process is based on sound medical and chemical principles. It is clear the CA BRN is headhunting for pro-life groups. Why a medical board would want women to have fewer safe, proven medical options and less informed consent is a mystery to me. 

Editor's note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News.

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