SFMMS Interview: Daniel Grossman, MD, FACOG

SFMMS INTERVIEW

Daniel Grossman, MD, FACOG

Steve Heilig, MPH

Daniel Grossman MD is a leading researcher in and advocate for improving reproductive health, widely known for his work in numerous aspects of that field. He is Professor, UCSF Department of Obstetrics, Gynecology & Reproductive Sciences and Director, Advancing New Standards in Reproductive Health (ANSIRH). He earned his MD at Stanford and did his residency at UCSF. A list of his extensive public and professional publications can be found at: https://bixbycenter.ucsf.edu/daniel-grossman-md-facog

How did you first decide to devote much of your career to working in the reproductive health and abortion arena?

When I was an undergrad at Yale, I got a fellowship to go to what was then called Zaire for the summer, at a very rural missionary hospital, and then in residency I did some work in Indonesia, and afterIfinishedresidencyinOB/GynatUCSFIdidsomework withotherorganizationsthere.Iwasfirstinterestedinglobal health,andsomeofmyfirstexperiencesinplaceslikesubSaharan AfricawhereIsawfirsthandhowchallengesinmaternalandchild health caused so much morbidity and mortality and saw so many people suffering from the consequences of unsafe abortion. I was just really shocked how many were having very serious medical complicationsandevendying,notbecausewedidn’tknowhow to diagnose or treat their problem, but because of bad policy. That really got me very interested in working at this intersection of medical care and public policy.

You’ve been very focused on medication abortion, and we’re now almost 22 years since the first approval of that by the FDA. How do you see that as having played out thus far?

There were immediately regulatory requirements applied tomifepristonethatwerecodifiedintheREMS–Regulatory Evaluation Mitigation Strategy – and that in addition to various state laws and regulations have really limited the number of providers who can provide it and patients that can use it. That said,atleastthere’sbeensomeprogressattheFDAlevelinrecent years – in 2016 the label for mifepristone was updated to be more in line with medical evidence, in particular the component concerning a requirement for in-person dispensing in a clinic, medicaloffice,orhospital,andcouldn’tbedispensedfroma pharmacy or mailed to a patient. That was then suspended in 2020 due to the COVID epidemic, and in 2021 the FDA announced they would permanently get rid of the in-person requirement. That said, they added another requirement that pharmacies wouldhavetobecertifiedtodispense,andwe’restillwaitingto see the details of that policy, and how easy it will be for clinicians to sign up and start providing. So the progress has been very slow and we have not seen the hoped-for reduction in barriers to access that seem to be possible with the advent of medication abortion here.

Just last year it was reported that just over half of all abortions are now being provided via medication. Do you think that it would be significantly higher without these restrictions?

Idon’tknowifitwouldbealotmorebutdothinkthatthere would be some increase, and that there would be more clinicians who provide it. It just can be challenging and cumbersome for some clinicians who do not have a lot of these patients to order it and have it on hand.

So one improvement would be to make it available on a regular prescription basis?

Yes, it should be possible to just transmit a prescription to a local pharmacy, or a mail-order pharmacy for mailing to patients. That would make a big difference.

You’ve also written about the possibility of “advance provision” of these pills; how would that work?

This was something we did back when emergency contraception was only available via prescription – we would give patients a prescription or the actual pills so they could take them in advance of need so they could take it as soon as possible, and that is still done. This could theoretically be done with medication abortionaswell,consideringthecommondelaysanddifficultiesin gettingtoaclinicgivengeographicandfinancialbarriers.People could take them as soon as they learned they were pregnant and it's likely they could get the abortion earlier in pregnancy. This might not comply with laws in every state now, but from a medical perspective it seems it would be very reasonable to screen for some of the contraindications for medication abortions that are unlikely to change in advance when medications are given to the patient, and encourage them to call right before they are about to useittoconfirmitisappropriateforthemtouse,andofcourse there could be appropriate follow-up as well.

Do you think the awareness of the availability of medication abortion has altered the epidemiology of abortion, such as making more abortions occurring earlier in pregnancy to take advantage of the option?

We do have some evidence that expended access to medication abortion that there was a decrease in second-trimester abortion, with some people reporting that having access to the pills was a factor. So a concerted effort to medication abortion can help people access abortion early in pregnancy. That said there will always be many who for various reasons will need to acquire an abortionafterthefirsttrimester.

You mentioned telemedicine – how does that figure into this picture going forward?

We now have a lot of evidence from the US and UK in particular demonstrating that telehealth provision of abortion is a model that reaches people in their homes and other places where we

can evaluate people for their eligibility for medication abortion based on their history and symptoms. Certainly some need to be seen in person, for ultrasound, blood work, and so forth, but the majority can be assessed via a telehealth basis and have the medication mailed to them. The FDA reviewed this data in a report last December which really came out in favor of telehealth abortion, strongly supported by the evidence. But about 19 states have now banned telemedicine for abortion and thus people in those states are already being denied access to medical progress.

Mail-order provision is also being targeted in this regard. This brings up Over-the-Counter status and access, and what are your thoughts there?

Just looking at the criteria for OTC status, I think medication abortionmeetsmanyofthosecriteria–it’sverysafe,there’sno risk of overdose, patients decide on their own whether they need andwantit,andwehavealotofevidencethatpatientscanfigure outwhetherit’sappropriateforthem,anduseitontheirown. There is a growing use of self-managed abortion particularly where it is now easily available or is restricted. So FDA would requirespecifickindsofstudiestobedonetodemonstratethat these criteria are met, and we are starting to do some of that kind of research. We just did a “label comprehension” study, with over 800 people, including many young ones, and showed that they could read and understand the key concepts in using this product. Next we are doing a self-selection study using previous research on how people can identify how far along they are in pregnancy and if they are eligible for medication abortion, comparing that to clinicians evaluation. And then we are planning an actual use study where you follow people in an OTC scenario where you see howwelltheyfigureoutiftheyareappropriateforusingitand how they do.

But actually getting it to be OTC would require a company to have a suitable product, such as a combi-pack product with both mifepristone and misoprostol, such as is already available insomeothercountriesbutnothere.SoIthinkit’sprobablyon the order of 5-10 years down the line before we see a serious application to the FDA for OTC approval. But in the process I think this research we are developing, like the simple label, an electronic screening tool for patients to help self-manage use, andever-increasingevidenceaboutsafetyandefficacy,canhelp bring that about. From an advocacy perspective if we have all this evidence it surely makes no sense to force people to come in, or not let nurse practitioners provide it.

The expansion of nurse practitioner scope of practice can be controversial, but your perspective is that it’s justified here?

There is a lot of evidence that nurse practitioners, nurse midwives, and physician assistants can all safely provide medication abortion, as they now can in California, but in a lot of states they are not allowed. Those restrictions are not based on any medical evidence.

What is your short “elevator speech” on the efficacy and safety of medical abortion?

The regimen for medication abortion, mifepristone with misoprostol when used up through about ten or eleven weeks is about 97% effective, with about 3% needing a vacuum aspiration orproceduralabortiontocompletetheprocess.It’sverysafe, with less than .5% of people who use it having any serious complications; it's safer than a lot of medication that are approved without any REMS restrictions for OTC access, such as Viagra and even Tylenol, to give a couple examples.

What would be your wish for the average non-specialist physicians to help this picture?

It would be great to have more getting educated about medicationabortion.Therearealotwhostilldon’tknowabout thisoption,butit’simportant,andasitbecomesmorepossibleto provide it via a prescription or otherwise, I hope more will learn how to provide what is really a very simple service. We really hope there will be increased uptake to meet patient needs better.

How about medical organizations?

I think advocating at the federal level to get rid of the REMS for these medications would be good. In the bigger picture, some sortoffederallegislation,liketheWomen’sHealthProtection Act that would limit the ability of the states to impose additional restrictions on abortion care that are not evidence-based would begood.AndIthinkthere’saroleformedicalorganizations that encourages the FDA to treat this medication like any other medication would, and to really look at the research in an unbiased fashiontoexplorethepossibilityofOTCaccess.We’realsolooking at how we might be able to provide tele-medication abortion across states lines, which would protect providers here so that evenifbreakingalawinanotherstatewe’dbeprotectedhere.

The current controversy and probability of Roe vs Wade being reversed would seem to be making all of this more urgent. The implications for healthcare and women’s health appear severe.

It’saloomingdisaster.It’sclearthatpatients’healthwill suffer. Some will be able to travel to access the care they need, but eventhentheycanbedelayed.It'sgoingtotakelotsoffinancial support to help them access what they need. Some will try to self-manage their abortions in areas where there are not easily accessed other options, and that is possible, but we also know there are higher legal risks associated with that, with women and even doctors being investigated and charged with having or helping others have any kind of abortion. And we know more will continue unwanted pregnancies to term, which some evidence shows can lead to a 20% increase in maternal mortality in those forced to do so, and even higher risk for, say, Black women. And Dr. Diana Green Foster did the ‘Turnaway” study here at UCSF which showed that women denied abortion are much more likely to be living in poverty, tethered to an abusive partner, with worse outcomes to the children born, and so forth.

You started with the experience of seeing the consequences of illegal abortion and lack of access firsthand. It’s now half a century since Roe, and not many people are still practicing who saw this here in the US. Do you think that leads to this being an abstract risk, historically, and thus less of a sense of urgency about preserving access to safe abortion?

Maybe so. It's really sad to think that we might have to experience that here, to see these awful consequences, to convince lawmakers to change the law back again. But very sadly, maybe that will be what it takes.