A hidden Gender Bias in Pharmaceuticals
By Callie Catacosinos
"How many times do I have to pee in this cup in order to get my prescription?"
As a 26-year-old, I really thought my acne days were over; it is shocking how wrong I was. A few months ago, finishing up my last year in law school, I found myself suffering from severe acne. I had a rolling cystic breakout that just would not clear. I went to the dermatologist and was suggested to try Accutane. I had known of Accutane from friends that had taken it over the years, and I knew of the serious side effects. I figured before I started cracking down for the bar exam, I might as well try the drug now. If I was suffering from the side effects, nothing too important would be impacted. As much as I knew about Accutane, I had no idea that there was a glaring gender inequity hiding beneath this tiny pill.
Accutane, which is the brand name for the medication Isotretinoin, seems to be a pretty good deal. [i] During your treatment, you take two pills a day for 4-6 months, and your acne is gone; however, there is a long list of side effects that can occur. Side effects can include bone or joint pain, extremely dry skin, liver problems, and birth defects.[ii] Birth defects include serious physical and internal deformities. Due to the impacts on the liver, while on Accutane, you are required to get blood tests, and if you are someone with a uterus, you also must get a monthly blood test for pregnancy or urine analysis in the doctor’s office. If you have a uterus, you also must use two forms of contraception while taking Accutane. Notably, even individuals who have undergone a tubal litigation procedure are still mandated to follow these protocols despite the extremely low chance they could still get pregnant, which is 1 out of 200.
The FDA states, “Unlike in female patients, there is no pattern of birth defects in babies whose fathers were taking isotretinoin. Approximately 3 to 5 babies in 100 (3% to 5%) are born with some kind of birth defect from other causes, not from isotretinoin.”[iii] The issue with this statistic is that there is nothing backing it up. When you search the footnote, the webpage it cites does not exist. Show me the receipts, FDA.
In order to get cleared to receive Accutane, I had to sign paperwork promising that I would use two forms of contraceptives. My doctor's office asked me to bring in my actual birth control pills. After I got cleared to receive the prescription, there is a monthly quiz on iPledge that I was required to fill out and pass to be able to physically get the prescription. If you do not fill it out, you will not be able to get your prescription. The questions are sex education questions, and only people with a uterus are required to answer this monthly. Examples of the quiz are below:
After you pass this test, you have 7 days to pick up your prescription because that is the allotted time when your pregnancy test results are still valid. For example, if you get approved for your prescription on January 26, you have until February 1st to pick it up. If you miss that date, then you must wait a full 30 days until you can get the medicine again. I was getting so stressed about my doctor's appointments and making sure that everything was timed perfectly to ensure I did not miss this window. I found myself in the dermatologist’s bathroom, peeing in a cup and wondering if anyone with a penis had to follow any of these protocols. I quickly learned that if you do not have a uterus, you do not have to take a monthly quiz, and you have 30 days to pick up the medication.[iv]
A study done in 2022 showed that, across the board, males were more likely than females to be prescribed Accutane. “Female patients have been reported to be under-prescribed isotretinoin relative to male patients despite being more likely to see a physician for acne.” [v] The study compared the number of prescriptions pre-pandemic and the number of prescriptions during the pandemic. 85 out of 581 females were prescribed Accutane pre-pandemic, compared to males, where 74 out of 225 males were prescribed it.[vi] During the pandemic, 62 females out of 723 were able to be prescribed acutance, and 64 men out of 229 were prescribed the medication.[vii] In all comparisons, “male patients had significantly higher odds of being prescribed isotretinoin than female patients.” [viii] The study concluded the extra steps that females have to go through to obtain a prescription for Accutane may influence the likelihood of prescription to female patients. Access to medication should be equal between the genders; it should not be more challenging for a female to get a prescription for Accutane than it is for a male.
Every month when I pick up the prescription, the box is filled with images of a pregnant person with an X going through it. There are more than 20 warnings advising female patients not to get pregnant. There is no mention anywhere about males advising them not to impregnate a female while taking the prescription.
One of the reasons that this inequality of testing raises such an alarm is because Isotretinoin has been found in the sperm. Researchers have not explored or extensively tested the impacts of isotretinoin found in sperm on fertilized eggs. There is no accountability or tracking for males and the birth defects in babies while they take Accutane. However, 3-5 babies out of 100 are born with a birth defect, and it is allegedly not from isotretinoin, but there is no scientific conclusion that explicitly rules out isotretinoin either. The government is not willing to extend the same level of rigorous testing and procedures on males prescribed Accutane based on one study that surveyed only 100 men taking isotretinoin which showed low numbers of children with birth defects. It's beginning to feel a lot like misogyny.
This is probably part of the article where you are wondering, what does Accutane have to do with the law? Well, Accutane is just a small reminder that the government often places an unequal burden on those of us who have a uterus when it comes to procedures around pregnancy. Under the Fourteenth Amendment: The Equal Protection Clause states, “No State shall make or enforce any law which shall abridge nor deny to any person within its jurisdiction the equal protection of the laws.”[ix] Under the Equal Protection Clause, there are some situations in which the government is allowed to discriminate. Federal agencies are “allowed to discriminate against individuals, as long as the discrimination satisfies the equal protection clause.”[x] The equal protection clause allows the laws to discriminate if "the agencies have a good reason or a 'rational basis’ for such choices.”[xi] Obviously, the FDA has a good reason to implement restrictions and have a strict process for potential child bearers to obtain Accutane. The state's interest is to prevent the birth of a child with severe mental and physical defects. However, why can't we close the gap between the inequality of the process for those who can impregnate and those who can become pregnant?
The constant burden of pregnancy is exhausting and frustrating; there is simply no reason as to why having a penis exempts you from taking monthly sexual education quizzes. The doctors should be asking the same sexual health questions to everyone, and it should be confirmed at every visit that everyone receiving a prescription is practicing safe sex. It might seem like a small issue, but these differentiations in treatment add up over time. If we don't call out sexual bias whenever we notice it, we risk allowing it to be normalized and accepted as the truth.
[i] Isotretinoin: Patient Safety- American Academy of Dermatology
[ii] Isotretinoin, https://medlineplus.gov/druginfo/meds/a681043.html
Callie is a 3L at New York Law school. She has been focused on Public Interest and Criminal Law. Upon graduation, she will be at New Jersey’s Public Defenders Office. She is currently in the housing Clinic at NYLS. When she is not doing work or in court, she is tending to her houseplants or hanging out with her friends.