The number of times we’ve turned to a medication to relieve our pain or cure our sickness is uncountable. We’ve been searching for ways to restore our health for ages, but today, modern drug development involves jumping through many hoops before a drug can come out the other end and be made available for public use. In this episode, we go from beginning to end of the process of discovering, making, testing and distributing a drug made for the market. We talk about research and development, clinical trials and pharmaceutical dispensing of a drug. Along the way, we talk about women, both the ones present and the ones we don’t see enough of, discussing the impact this has on women’s health and the success of a drug!
We’re making movement forward, but what ELSE do you think we need to do to support women in realms of science, research and drug development?
The newest drug on the market might not always be the best option for a patient, but how can we as physicians be better about critically analyzing the role of pharmaceutical companies in our lives as they try to get us to work with them while keeping our patients’ best interests in mind?
Listen to the episode, discuss these questions with friends and family, let us know what you think!
This episode covered the development of a drug from the beginning to end of the process and analyzed the roles of women or lack thereof along the way.
Part 1: Making the drug
In basic science labs, the synthesis of the drug and preliminary testing of the drug takes place. Then in preclinical tests, a.k.a. Animal trials, questions like the exact mechanism in the body, best dosage, side effects, etc. are tested.
Even in animal studies, females were often not tested on before 2016, when the NIH required for the inclusion of both male and female samples in animal studies which has improved inclusion practices a bit.
In basic science and translational research, female-identifying researchers are underrepresented as well. Compared to their male counterparts, women scientists spend more time outside of lab mentoring students and junior faculty members, representing minority folx on panels and committees, and then also often being caregivers to their families. So they actually end up missing out on extra time to apply for grants, to network and to take advantage of opportunities to move forward in their careers.
Part 2: Testing the drug (Clinical Trials)
Questions that are asked in a clinical trial are like:
- Who qualifies to participate in this trial?
- How many people are we going to enroll in the study
- Is there going to be a control group or is it even ethical to have a group that gets no or minimal intervention?
- How are we getting the drug to the patients and how much of it are we giving?
- What outcomes are we checking for? How do we make sure that the data is analyzed in an unbiased way?
Phase 1 is usually several months long and tests the drug on healthy people to see how much of the drug the body can handle, what side effects are there maybe, is it safe, etc. Around 70% of drugs do move on to the next phase which is phase 2.
Phase 2, up to several hundred people with the disease we’re looking at get divided into a group that gets the drug and a group that doesn’t. Usually the groups don’t know which drug you got, and this is supposed to help minimize bias. About 33% of drugs move on to the next phase.
Phase 3 research involves 300 to 3000 volunteers who have the disease, and here the studies have to show that the drug offers a treatment benefit to the population over the current control option. These studies are usually longer and reveal more long-term or rare side effects. Around 25-30% of drugs move to the next phase.
The last phase is phase 4, where several thousand volunteers with the illness take the drug and eventually it’s approached by the FDA during Post-Market Safety Monitoring.
There are also many drugs that are harmful to women because they were not tested on women during clinical trials due to the lack of women as subjects in said trials.
Part 3: Getting the drug to the public
Pharmaceutical companies have all these sales reps that are supposed to develop professional relationships with physicians and once they do that, they have a higher likelihood of getting that physician to prescribe THEIR companies brand of a drug to patients.
Also the ways that Big Pharma targets female buyers ties really well into the medicalization of female bodies.
For example, Premenstrual Dysphoric Disorder (PMDD), is a psychiatric disorder reserved for women in their menstrual age who get really bad Premenstrual syndrome or PMS, and to treat this disease they have rebranded an antidepressant, Prozac, into Sarafem, which are both SSRIs.
Office of the commissioner. (2018, January 4). The Drug Development Process. Retrieved March 24, 2021, from https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
Cambronero Saiz, B., Ruiz Cantero, M. T., & Papí Gálvez, N. (2012). Quality of pharmaceutical advertising and gender bias in medical journals (1998–2008): a review of the scientific literature. Gaceta Sanitaria, 26(5), 469–476. https://doi.org/10.1016/j.gaceta.2011.11.002
Empowering Women to Lead in Science. (n.d.). Retrieved March 24, 2021, from https://campaign.ucsf.edu/stories/empowering-women-lead-science
Parekh, A., Fadiran, E. O., Uhl, K., & Throckmorton, D. C. (2011). Adverse effects in women: implications for drug development and regulatory policies. Expert Review of Clinical Pharmacology, 4(4), 453–466. https://doi.org/10.1586/ecp.11.29
Podcast, C. (2020, June 18). Beyond the Science: Big Pharma’s Influence on Healthcare Providers and Patients. Retrieved March 24, 2021, from https://www.citedpodcast.com/beyond-the-science-big-pharmas-influence-on-healthcare-providers-and-patients/
Ravindran, S. T. K. (2020, October 27). Making pharmaceutical research and regulation work for women. Retrieved March 24, 2021, from https://www.bmj.com/content/371/bmj.m3808
Sokol, J. (2010). Marketing Pharmaceutical Drugs to Women in Magazines: A Content Analysis. American Journal of Health Behavior, 34(4), 402–411. https://doi.org/10.5993/ajhb.34.4.2
Stone, J., & Stone, J. (2012, October 2). Drugs in Search of a Disease Pharma Targets Women. Retrieved March 24, 2021, from https://blogs.scientificamerican.com/molecules-to-medicine/drugs-in-search-of-a-diseasepharma-targets-women/