Healthy Hooha

Women are often the target of pharmaceutical companies prioritizing profits over patients’ well-being, particularly when it comes to addressing women’s health disparities. One such case is the recent development of an oral drug, being called Zurzuve/zuranolone, to treat postpartum depression (PPD). The drug works by stimulating allopregnanolone, a neuroactive steroid byproduct of the hormone progesterone. Stimulation of allopregnanolone in the brain is believed to lead to a reduction in depression and anxiety, and increased sense of wellbeing and calmness, and can assist in relieving insomnia due to its sedative effects via it’s interaction with GABA receptors in the brain.

During pregnancy, progesterone levels are very high but after delivery those levels plummet and the rapid drop in progesterone (and estrogen) can cause many undesirable effects like postpartum depression. PPD is a complex and multifaceted disorder with symptoms ranging from mood swings, anxiety, and sadness to feelings of isolation and hopelessness, or worse-harming their child or themselves. PPD can lead to a myriad of negative consequences, affecting not just the mother but also the child and the family as a whole.

The idea behind the new drug is to have the patient take the pill every day for 14 days to boost allopregnanolone and stimulation of the GABA receptors, buffering the brain and body against the rapid drop in progesterone from giving birth and allowing a more controlled withdrawal process. 

Recent news headlines have brought attention to the drugs new FDA approval for the treatment of PPD with the statement “We see potential for zuranolone…..to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with major depressive disorder and postpartum depression,” Dr. Priya Singhal, executive vice president and head of development at Biogen. However, there is not a “serious unmet need” for this medication but pharmaceutical companies will have you believing there is due to their inability to patent and make substantial revenue from a treatment we’ve had available for decades—P4 Progesterone, a drug that has the same molecular structure to the progesterone humans make inside their body, which then naturally metabolizes into allopregnanolone, is also available in pill form, and works just as fast. (The pharmaceutical company acknowledges that other treatments like SSRI’s are available and work as effectively as zuranolone, but take much longer to achieve effect, whereas zuranolone begins working right away)

While it can be beneficial to explore new treatments for various conditions, the concerning aspect of this new drug is the marketing of it as “novel”, and “meeting an unmet need”, with the disregard of an alternative treatment that has existed for decades, works as effectively as zuranolone and is just as convenient.

The makers of zuranolone also mention that “low-income mothers and women of color, and those with limited healthcare access are at higher risk of PPD and are less likely to receive PPD care” but new drugs are always very costly for the patient without insurance; drug coverage insurance rarely covers new brand name prescriptions and when they do the copayments are typically cost prohibitive to the patient population just mentioned, so who will this drug actually benefit, and who will have access?

Despite the decades-long history of P4 progesterone supplementation as an available treatment for many conditions affecting women (such as heavy periods, menstrual cramps, pregnancy loss prevention, menopausal hormone therapy adjunct, etc.) it often remains neglected in favor of promoting newer, patentable, synthetic drugs that many times come with long lists of negative effects women prefer to do without but who are not informed of lower costing, more alternative treatments that are available as options. P4 progesterone supplementation is a safe and effective option, with a wealth of research backing its benefits. Its human identical molecular structure makes it more compatible with a woman’s body and greatly reduced risk of adverse effects. Furthermore, P4 progesterone supplementation is available as a generic and is very low cost, making it affordable and accessible for a broader population.

“Rapidly acting antidepressant therapies are needed and this would be the first oral drug formulation of a rapidly acting antidepressant” Meltzer-Brody said in an email.

This statement is misleading. Progesterone ALSO metabolizes into allopregnanolone, so why the need to create the drug and claim there isn’t an alternative option? Many reasons including the disinterest in obtaining approval of oral P4 progesterone as a fast acting and better tolerated antidepressant to treat PPD.

Another issue in the creation of zuranolone is its cost. Since this drug is unique in its composition is it patentable and pharmaceutical companies can set high prices without competition. This financial burden falls on patients, prescription benefit insurance usage, and healthcare systems, making treatment less accessible to those who need it the most. Progesterone is a naturally occurring molecule and therefore not patentable making it significantly cheaper and more widely available.

This case of the new FDA approval for zuranolone highlights the concerning trend of pharmaceutical companies prioritizing profit over patients’ well-being, especially in the context of women’s health. In addition to the concerning trends in pharmaceutical practices, media headlines and quotes by those being interviewed surrounding the approval and promotion of zuranolone are misleading and inaccurate. Sensationalized claims of “meeting an unmet need” and being a “novel” solution downplay the existence of a long-established, natural alternative in P4 progesterone supplementation. Despite the existence of progesterone supplementation, the marketing and development of zuranolone as a novel treatment for postpartum depression potentially sways public and clinician opinion, and healthcare decisions without providing a fair comparison of available treatment options. The pursuit of patentable, synthetic drugs not only disregards the decades-long history of P4 progesterone’s benefits but also leads to inflated drug prices, making treatment less accessible for those in need. As a result, patients, prescription benefit insurance usage, and healthcare systems bear the financial burden. By recognizing and promoting the value of more affordable alternatives like P4 progesterone supplementation, we can prioritize patient well-being and ensure equitable access to effective treatments for women’s health conditions without exploitation of women’s health disparities. This calls for greater commitment to patient-centered care in the pursuit of improved health outcomes and critical evaluation of media coverage and the accuracy of quoted statements is essential to ensure that patients and healthcare professionals are well-informed and can make decisions based on transparent and reliable information.

Referenced media articles: https://www.cnn.com/2023/08/04/health/fda-approves-first-postpartum-depression-pill-in-the-us/index.html , https://www.wired.com/story/the-first-pill-for-postpartum-depression-is-almost-here/