We previously wrote about lessons the FDA learned (or should have learned) from the approval and subsequent withdrawal of Makena, a hormone for prevention of preterm birth. However, there’s another aspect of the Makena case that’s worth exploring more in depth — the racial equity implications of the drug approval and discussion around this issue.
Racial equity and drug approvals
Racial equity has been a growing topic of conversation regarding drug approvals. Confronting structural racism requires dialogue with all actors in the healthcare system. However, what could be a fruitful conversation has been largely co-opted by pharmaceutical companies and pharma-funded groups as a method for trying to get drugs with unclear benefits approved.
At the recent Makena hearing, one of Covis pharmaceuticals’ key arguments was that Makena should remain on the market as a health equity intervention, because the drug may benefit Black women. This claim is based on the fact that a 2003 trial of Makena was positive, and this trial was conducted in the US with a majority Black women in the trial. However, there were some serious methodological flaws that called the results into question.
Makena’s manufacturer was required to conduct another trial, called PROLONG. This trial had a larger international cohort (since Makena was already on the market in the US, it was harder to recruit American women for the trial) and participants were mostly white women. This trial did not find a significant effect on preterm birth, regardless of the participants’ race, risk level, or other characteristic. The FDA wrote they were “unable to identify a group of women for whom Makena had an effect” in the confirmatory trial.
The differences between the two trials does not mean that the drug is effective in Black women. Neither trial showed a difference between drug effectiveness by race. The PROLONG trial had three times more participants than the previous trial and did not have the methodological problems as in the previous trial. PROLONG was designed to confirm that Makena decreased preterm birth-related health issues for infants, and not only was there no difference in infant health, but there was no different in the surrogate outcome of preterm birth at 37 weeks.
Given these findings, keeping Makena on the market would be a deeply inequitable decision. Because Black women are more likely to be at high risk for preterm birth, they would be more likely to be prescribed this unproven drug, and thereby exposed to unnecessary risk of drug side effects including headaches, depression, and cancer.
Let’s not forget, drug companies did not rush to get Makena approved because they cared so much about racism. Makena is a branded form of a very old $10 drug that was repackaged by a drug company and sold for $1500. Medicaid has spent $700 million on Makena in the past three years alone.
Pharma-funded claims
The FDA was not swayed by Covis Pharmaceuticals’ claim that the drug should stay on the market for purposes of racial equity. But it is concerning to see the crucial topic of racial equity being used to advocate for ineffective drugs. Covis did a great job spreading their message (read: money) around to specialty and advocacy groups to get their support. In many cases, pharma-funded groups brought up the issue of racial disparities in Makena’s defense.
For example, the senior advisor for HealthyWomen (Covis is on their corporate advisory council) wrote in a comment to the FDA, “Now is not the time for the FDA to exacerbate an ever increasing maternal health disparity in maternal and infant health outcomes between Black, Indigenous, and women of color and their white counterparts.”
Other specialty groups including the Society for Maternal-Fetal Medicine and the American College of Gynecology received funding from AMAG Pharmaceuticals, the previous owner of Makena. These and many other organizations belong to the Coalition to Advance Maternal Therapeutics, which is funded by Covis and other pharmaceutical companies. Covis also funded the creation of a group by the National Consumers League called the Preterm Birth Prevention Alliance to share patient stories about preterm birth at the FDA hearing.
Next in a pattern
Covis Pharmaceuticals isn’t the first to argue that an unproven drug should kept on the market for the sake of racial equity. Drug company Biogen used a similar argument to urge Medicare to cover their Alzheimer’s drug Aduhelm. Biogen and pharma-backed patient organizations called CMS’ decision to restrict access to the drug “discrimination” since people of color are at greater risk for Alzheimer’s.
Biogen, the makers of Aduhelm, claimed the CMS decision would “exacerbate health inequity in dementia care.” And the Alzheimer’s Association, a patient organization that receives funding from Biogen, called the decision “shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics.” This argument ignores the fact that we don’t know if Aduhelm actually works to reduce Alzheimer’s symptoms or progression, and that Biogen did not recruit enough people of color in their trials to match the levels of Alzheimer’s seen these groups.
And again very recently, the head of a pharma-funded advocacy group penned an op-ed in StatNews arguing for more access to PET scans for the sake of health equity — so that Black people could more easily access Alzheimer’s drugs that haven’t been proven to work.
What we need to talk about
Achieving racial health equity is incredibly difficult. It will require all actors in our health system — doctors, patients, hospitals, insurers, government agencies, pharmaceutical companies, etc. — to tackle structural racism at its core and to put power into the hands of communities most impacted by racism. The idea that unproven drugs like Makena and Aduhelm can solve racial disparities is a tempting shortcut, but a very misguided one.
Imagine that we did uncover a drug that cured Alzheimer’s disease, preterm birth, or another of the many health conditions more likely to impact people of color. Black, Hispanic, and Indigenous Americans would still be less likely to access this hypothetical miracle pill because of factors created by structural racism. People of color are less likely to have health care coverage than white Americans, less likely to be able to afford out-of-pocket costs for drugs, and less likely to be prescribed drugs that work.
The idea that unproven drugs like Makena and Aduhelm can solve racial disparities is a tempting shortcut, but a very misguided one.
Many people of color already have trouble accessing medications that already exist. Black individuals with atrial fibrillation are significantly less likely to receive direct-acting blood thinners (the safest, most effective type of blood thinner) than white patients. People of color are also less likely to receive buprenorphine for opioid addiction and more likely to report underuse of diabetes medications because of cost. And during Covid-19, Black and Hispanic/Latinx individuals were less likely to have access to antibody therapy or other novel treatments.
Racial health equity will not be attained through spending hundreds of millions on unproven drugs. We have to address the structural racism that leads to these disparities. That means implementing universal coverage, addressing provider unconscious bias, tackling residential segregation and hospital segregation, improving the social conditions in communities of color, and a myriad of other policies.
For their part, drug companies can ensure they represent all Americans in clinical trials, invest more in research for underfunded conditions that predominantly impact people of color like sickle cell anemia, and stop raising their prices unnecessarily (discounts through charities don’t count).
Racial equity is a real goal that we all need to work together to strive for — not a talking point to market unproven drugs.