Thread by @DrDGrossman

Hi @tedcruz & @LilaGraceRose. I saw your latest op-ed on the court's decision to make medication abortions more accessible in a few states during the coronavirus pandemic.

I hope you won't mind if I offer a few edits and fact check the piece. 📝

First, 11 of the 24 deaths were not even associated with abortion—these women died from things like drug overdose or homicide. It's unfortunate, however not related.

All medical procedures have some risk, but medication abortion's risk is extremely low, especially over 20 years.

Second, the denominator is 3.7 million women who have used it, so the overall rate of death is very low. Lower than the risk of death with childbirth (at least 14 times lower) or for a man using Viagra or other drug for erectile dysfunction.
ansirh.org/sites/default/…

This is incorrect—the ruling does not suspend the REMS. The REMS is still in effect. Clinicians dispensing mifepristone still have to be certified. Patients still need to be given the FDA-approved medication guide and sign the FDA-mandated Patient Agreement Form.

The medication may not be dispensed in pharmacies on prescription. The *only* thing that has changed is that certified clinicians may now mail the medication directly to patients instead of handing it to them in person in the clinic or doctor's office.

Rather than judicial activism, elected officials should ask why the FDA has not responded to the COVID-19 pandemic the way regulatory agencies have in the UK to allow mailing of medications after a telemedicine assessment (Australia already allowed this before the pandemic).

Given the evidence about the safety of providing medication abortion by telemedicine and the risks to patients of requiring medically unnecessary visits to a clinic during the pandemic, the FDA should have made this change before it was forced to because of litigation.

@acog has said that ultrasound is not required prior to medication abortion for patients with a sure last period and no risk factors for ectopic pregnancy. (acog.org/clinical-infor…)

FYI: Ectopic pregnancy occurs in <1% of those seeking medication abortion.

Of course the embryo is growing, that's how pregnancy works, however they're not fully formed in the first trimester. (healthline.com/health/pregnan…)

I'm curious, would you be willing to abolish all restrictions on abortions up to 10 weeks making it completely accessible earlier?

Checking your math here since it's missing a denominator for context. Again, the denominator is 3.7 million, making this is a very low rate of adverse reports. The adverse events also span the gamut from mild to severe. This deserves nuance and they shouldn't be lumped together.

Between 2000 and 2016, any clinician who identified a serious adverse event related to mifepristone use was required to report it to the FDA and the drug's manufacturer.

So during that period, emergency rooms *were* required to report adverse reactions. And there were so few that the FDA decided in 2016 to remove that requirement. Only deaths related to mifepristone use are now required to be reported.

Fun fact: This Obama-era change was based on a recommendation from the scientific staff at the FDA. In addition the US Government Accountability Office (@USGAO) issued a report to Congress in 2018 regarding the changes in the labeling for mifepristone. gao.gov/assets/700/691…

The GAO found that the FDA followed its standard review process when it approved the revised labeling based on reviews of peer-reviewed published studies.

Here's the link in case you want to read it: gao.gov/assets/700/691…

We actually have a lot of evidence about the rate of adverse events with medication abortion. The risks are lower than continuing the pregnancy to term (since, uh, that's the alternative).

The most rigorous study of medication abortion safety included data from 11,319 MediCal patients in California. In this study, only 35 (that's 0.31%) had a major complication, defined as hospitalization, blood transfusion, or surgery. ansirh.org/sites/default/…

It's really dangerous to throw numbers like this around without any context. The reality is that there are some risks associated with pregnancy, regardless of whether the pregnancy ends in an abortion or childbirth.

The risk of needing a blood transfusion is about 10 times higher for childbirth compared to abortion.

Here's a hypothetical math problem: if 4 million chose to continue their pregnancies to term, we would expect about 40,000 would get a blood transfusion.
liebertpub.com/doi/10.1089/jw…

If 4 million patients chose to get an medication abortion, research tells us about 4,000 will get a blood transfusion due to heavy bleeding.

You do the math.

(It's less than the 40,000)
liebertpub.com/doi/10.1089/jw…

Um, actually, there are health risks associated with continuing an unwanted pregnancy to term. acpjournals.org/doi/10.7326/M1…

Medical groups, including the AMA and ACOG disagree.

You've used this intentionally vicious rhetoric throughout your piece, which is designed to fan the flames of violence and threats towards abortion providers and people who seek abortions. This is dangerous and you cannot feign surprise when someone harms us.

On this point, we agree: pregnant patients deserve better. The maternal mortality rate is abysmal.

I look forward to seeing you work toward the passage of the Black Maternal Health Momnibus Bill (S3424). It looks like you're not yet a cosponsor, @tedcruz: c-span.org/congress/bills…