Over the last few months, a drug has found
its way into the headlines in the US on a regular basis.
Mifepristone has been the subject of laws
and court cases centering on its role in medication abortion.
Some people are calling for the drug to be banned altogether,
with one argument being that it poses a safety risk to patients.
That argument has made it all the way to the US Supreme Court.
However, some abortion rights advocates
and patients say that if anything, the drug should be easier to get.
After all, they argue, why should mifepristone be tightly regulated
when it’s actually safer to take than many other drugs on the market?
And the talking point they’re using is “Mifepristone is safer than Viagra?
So today we’re going to try and get to the bottom of this particular talking point.
But we’re also going to look at the science behind
why we know mifepristone, or any drug, is safe.
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Mifepristone is sold under the brand name Mifeprex,
and it’s the first pharmaceutical in a pair typically used for medication abortion.
It has other uses too, but this is the one we’ll focus on.
It blocks the effects of progesterone, a hormone that’s important in pregnancy.
Without progesterone, the fetus detaches from the uterine wall,
and the pregnancy is terminated.
A patient will typically take mifepristone and then follow it up immediately or up to
48 hours later with a series of doses of misoprostol, which causes contractions.
Taking mifepristone and misoprostol together can be up to
98% effective if taken early enough in pregnancy.
A second dose, as needed, makes that number more like 99% overall.
This combo is also used for managing early miscarriages.
When a miscarriage happens in the first trimester,
a patient has three options: medication management, a physical procedure,
or just waiting for it to pass naturally from the body.
Doctors used to only use misoprostol if a patient selected the medication route,
but in about 30% of cases, the patients would need
further doses or a physical procedure to pass their miscarriage.
So now doctors prescribe the mifepristone and misoprostol combo
as the standard of care, and it’s much more effective,
even though this technically isn’t an FDA-approved way to treat miscarriage.
So mifepristone definitely works, and is used to
provide care to a variety of people who need it.
But that’s only half of what scientists and regulators want to know when deciding
if a drug should be made available to folks.
The other half is whether it’s safe to use,
and regulatory processes are designed to find that out.
Mifepristone was developed in the 1980s and first approved
in China and France in 1988.
After reviewing studies conducted here and abroad,
the FDA approved mifepristone in the US in the year 2000,
and it’s currently approved in more than 90 countries.
And in the US, medication abortions account for over half of all abortions.
Which creates a ton of opportunity to collect data on the safety of mifepristone,
which should make it easy to know if it is actually safer than,
our thesis here, taking Viagra.
Except it’s not quite that simple.
Because no one does clinical trials, or even indirect comparisons,
between two totally different drugs used for two different purposes.
Comparing Drug A for Use A to Drug B for Use B would cost a lot of effort
and money, and wouldn’t tell doctors anything that would help patients.
Instead, clinical studies often compare whatever
intervention is being tested to the standard of care.
Standard of care can mean a lot of things, but in the case of abortion medications,
we’re generally looking at the other things that may
happen to patients who are pregnant: surgical abortions and live birth.
And what shakes out from that research is that medication abortion has a
slightly higher rate of complications than surgical abortion,
and a much lower rate of complications than giving birth.
In case it is not clear here, I should emphasize that
no one is saying that one of these outcomes is better than the others.
It’s simply a way of looking at the risk to patients
who are in similar situations to one another.
So compared to the other options for pregnancy,
we know that mifepristone is safe.
So where does Viagra come in?
The FDA keeps track of adverse events after taking a drug, that is,
the times and ways people were harmed.
This database is available to the public.
It’s called the FDA Adverse Event Reporting System, or FAERS.
And it is not a perfect system.
For one thing, while drug companies have to report any adverse effects that
they know about, like ones that happened during clinical trials,
there’s no rule that doctors or patients have to report events.
So it’s likely that FAERS undercounts adverse events, especially minor ones.
It also doesn’t have any way of teasing apart
whether the adverse event was caused by the drug.
It simply says that someone was taking a drug, and then a bad thing happened.
But if you actually want to compare the safety of two totally different types of drugs,
FAERS is probably the most objective way to do so.
So as of June 2022, the FAERS database reports 28 deaths in patients in the US
who had taken mifepristone in the more than 20 years since it’s been approved.
However, about half of those were due to things that were not
directly related to the drug itself… including several homicides.
The deaths that seem more likely to have potentially
been related to the drug were from things like infection.
So that shakes out to a death rate of somewhere between
0.35 and 0.65 per 100,000, depending on which cases you count.
Drugs in the group that includes Viagra, on the other hand,
have a death rate of around 4 per 100,000 users.
Eight times higher than mifepristone.
Again, though, comparing the safety of two drugs used for
completely different purposes is kind of comparing apples and oranges.
But the FAERS database is the best we have when it comes to thinking about
how the risks of the drugs we’re prescribing every day stack up against each other.
And it is a transparent way to look up the risks of any drug on the market.
So if you want to use the “mifepristone is safer than Viagra” talking point,
just know that that is where it comes from.
Mifepristone is definitely safe when evaluated in the proper context, though.
And its safety profile is tight enough that some
healthcare advocates want to loosen its restrictions.
See, in the US, mifepristone is currently more regulated than most other drugs.
It’s under what the FDA calls a Risk Evaluation and Mitigation Strategy, or REMS.
That program is meant to make sure that providers are prescribing the
most dangerous drugs safely and properly monitoring the patients on them.
Let’s consider clozapine, an antipsychotic.
That’s a needed treatment for some patients.
But it can totally tank your ability to fight certain infections,
which could put those patients at risk.
So the REMS requires that a prescriber be certified,
the patient be made aware of the risks, the patient’s white blood cell count
be regularly checked and reported to the REMS program,
and any pharmacies that prescribe it must also be certified.
FAERS reports more than 23,000 clozapine-related deaths since 1989.
REMS medications also include Turalio,
an anti-tumor medication that can cause severe and potentially fatal
liver complications in around 2% of patients.
In addition to prescriber and pharmacy certification,
it requires frequent liver testing and that a patient initially be given a limited supply.
Under the REMS requirements, it used to be that only specially-certified doctors
could prescribe mifepristone, and it had to be given
directly to the patient by that doctor, in person.
In the wake of the pandemic, the FDA has made some changes
that make mifepristone easier to get, if it remains legal.
Patients can now get a prescription through a telehealth appointment
and receive the drug by mail, and retail pharmacies
can choose to become certified to dispense mifepristone.
While that doesn’t mean every corner pharmacy now has it, these changes
have made medication abortions more accessible to many patients.
Some hoops remain.
You have to find the right pharmacy if you don’t want to go the mail-order route,
and only certain healthcare providers may prescribe mifepristone.
Patients also have to sign a form saying that they understand all the possible risks.
None of which are necessarily bad things,
but they are things that we don’t do with most other drugs.
And the drugs we do do them with tend to be much riskier than mifepristone;
carrying a risk of addiction, for example.
At this point, mifepristone has been studied for more than thirty years in
hundreds of thousands of people worldwide.
This video has been pretty America-centric because we’re the ones
currently arguing about it, but mifepristone is
being used safely in plenty of other nations too.
So if it was an especially dangerous drug, we’d know,
and either a regulatory agency or the manufacturer
would likely have pulled it from the market.
It does happen.
Sometimes, despite our best efforts, clinical trials
will miss something important that comes out after a drug hits the market.
For example, look at Vioxx, a painkiller that was approved by the FDA
in 1999 based on clinical trials of about 5000 people.
After it was approved, the manufacturer conducted
a few studies to learn even more about the drug.
Long story short, they discovered an increased risk of heart attack and stroke,
and the manufacturer pulled Vioxx from the market in 2004.
But in the case of Mifepristone,
all of the available evidence points to the same place: it’s safe.
Saying that it’s safer than Viagra is a splashy,
but messy, way to make that point.
But we know that there is rigorous evidence that the FDA and
medical providers are tracking to support their policy and prescribing decisions.
Basically, the methods we use to approve
and prescribe drugs are based on science.
Science is a human endeavor, and that means it is sometimes flawed.
But it’s also the best thing we’ve got going
to make sure things are safe for everybody.
The next step is to make sure they’re fair, too.
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