There is a long and unfortunate history of gender bias against women in the field of medicine.[1] Over the centuries this bias has festered into a global issue that negatively impacts women’s health to this day.[2] This bias has bordered on the absurd—for example—using male subjects to study the impact of obesity on breast and uterine cancer.[3] The field of medicine has made but tepid advances towards correcting this historic wrong. One of the many symptoms of this bias is a systemic lack of informed consent from female patients. This is contrary to the efforts of the legal community which has emphasized the importance of informed consent.
The Nuremberg Code played an important part in the international community’s emphasis on informed consent. The First Article of the Code states that:
“The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.…”[4]
The principle of informed consent was codified in many international agreements. The Declaration of Helsinki states that “[i]n medical research involving competent human subjects, each potential subject must be adequately informed of the … anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study.”[5] Article 7 of the International Covenant on Civil and Political Rights (ICCPR) states that “[n]o one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”[6] The United States signed the ICCPR in 1977 and ratified the treaty in 1992.[7]
The United Nations Educational, Scientific, and Cultural Organization’s (UNESCO) Universal Declaration on Bioethics and Human Rights states that “[a]ny preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information.”[8] Additionally, “[s]cientific research should only be carried out with the prior, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent.”[9] Finally, “[i]n no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.”[10]
The 20th century saw developments in American jurisprudence regarding the principles of informed consent that laid the foundation for patient autonomy.[11] These cases included the likes of Pratt v. Davis and the seminal case of Schloendorff v. Society of New York Hospital, both involving the removal of a woman’s uterus without her consent.[12] These principles have since been codified in the United States’ federal regulations. For example, 45 C.F.R § 46 regulates the protection of Human Subjects.[13] It is a comprehensive regulatory framework that governs the ethical conduct of research involving human subjects in the United States.[14] Federal Courts have taken this statutory scheme to stand for the proposition that there are strict requirements when dealing with biological research, including “advising the patient of the possible risks, any alternative treatments available and above all that the treatment is part of a research study.”[15]
To sum up, the doctrine of informed consent is well enshrined in both international and American law. It requires a patient to be adequately informed of both the risks and benefits of a certain treatment or when participating in clinical studies.
The practice of this doctrine fell woefully short during the Covid Pandemic. Shortly after Covid vaccines were cleared for emergency use authorization, rumors began to swirl that the vaccines were disrupting female menstruation cycles.[16] Thousands of reports mentioning these side effects were filed with regulators in the United Kingdom.[17] After reviewing these reports, the Medicines and Healthcare Products Regulatory Agency (the Agency) informed the public that it “does not support a link” between menstruation changes and the Covid vaccines.[18] The Agency is the United Kingdom’s regulatory body that oversees medicine and medical devices. This conclusory statement was made despite the fact that menstrual disturbances “were not addressed in the preceding clinical vaccine trials.”[19] In other words, no one bothered to see if the vaccines would have unique adverse impacts on women. That statement was released to the public in 2021, shortly after the vaccines went public. Fast forward to 2022 and 2023 and the Agency’s statement becomes obsolete.
In the Summer of 2022, a systematic review of 14 studies found that of 78,138 women participants in qualifying studies, 39,759 (52.05%) of them experienced “some form of menstrual problem after vaccination.”[20] However, due to the lack of homogeneity among the data, the review could not establish a causal relationship between the vaccine and menstrual problems. The studies showed a variety of menstrual problems such as “menorrhagia, oligomenorrhea, and dysmenorrhea.”[21] Of note, the review acknowledged that because there was a “lack of published research articles” on the topic of menstruation issues, they had to turn to studies which were “preprints” in order to have a large enough sample size to effectively conduct the analysis.[22]
Fast forward a few months to October of 2022, and the European Medicines Agency in their “Meeting highlights from the Pharmacovigilance Risk Assessment Committee” recommended to add “heavy menstrual bleeding” as a side effect of “unknown frequency” to the product information pages of both Comirnaty [Pfizer] and Spikevax [Moderna] Covid-19 vaccines.[23] The medicinal regulatory arm of the EU stated that “[a]fter reviewing the data, the Committee concluded that there is at least a reasonable possibility that the occurrence of heavy menstrual bleeding is causally associated with these vaccines and therefore recommended the update of the product information.”[24] This acknowledgement was released a year after women began sounding the alarm worldwide.
Another year later in September of 2023, the Norwegian Institute of Public Health published a study of “post-, peri- and premenopausal women [which] finds increased risk[s] of vaginal bleeding after COVID-19 vaccination.”[25] The study acknowledged that after the Covid-19 vaccination, reports of menstrual disturbances were seen at “frequencies not seen in previous vaccination campaigns.”[26] The main conclusion of the study is presented in full:
[W]e have observed an increased risk of unexpected vaginal bleeding after COVID-19 vaccination in nonmenstruating women across different stages of reproductive aging. Among post-, peri-, and premenopausal women, 3.3, 14.1, and 13.1% reported having one or several unexpected vaginal bleeding episodes during the last 8 to 9 months, of which approximately 50% were reported to have happened within 28 days of vaccination. In postmenopausal women, the risk of vaginal bleeding was increased two to threefold in the 4 weeks after vaccination, as compared to the prevaccination period. The association with vaccination was slightly stronger in peri- and premenopausal women where the risk was increased three to fivefold. In premenopausal women, the first 4 weeks after a dose of Spikevax [Moderna] was associated with a 32% increased risk as compared to Comirnaty [Pfizer].[27]
The historical bias against women in the field of medicine is alive and well. In the era of Covid it presented itself as a dismissal of side effects experienced by women and subsequent misleading statements from regulatory agencies. Compare the following two possible statements which could have been issued after women began reporting side effects after vaccination:
- “Due to the quick nature of this vaccine’s development, we did not have time to study its impact on menstrual cycles. It is possible that the vaccine will impact cycles, but we do not know for certain yet.”
- “We do not support a link between vaccines and menstrual changes.”
One statement is honest and provides the requisite information (or lack thereof) that a patient would need in order to give informed consent. The other statement is misleading. However, it is okay for medical professionals to not know the adverse effects of an emergency use vaccine as long as that information gets passed along to patients. The patients can then weigh the pros and cons of the treatment and decide what is in their best interest.
The first article in the Nuremberg Code stated that “[t]he voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent … and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.…”[28] It is difficult for a patient to comprehend the risks and benefits of an emergency use vaccine if they are misled by the regulatory agencies. Unfortunately, the Nuremberg Code and the majority of international agreements are not legally binding on the states that sign them. However, the ICCPR has been ratified by the United States and provides a potential mechanism for those seeking accountability from regulatory agencies and pharmaceutical corporations. Hopefully our regulatory agencies will provide more honest disclosures in the future—especially for those who continue to suffer most from systemic biases in the healthcare industry.
[1] See generally Cecilia Tasca et al., Women and Hysteria in the History of Mental Health, 8 Clinical Prac. & Epidemiology in Mental Health 2012, at 110 (Aug. 7, 2012).
[2] See id.
[3] Rebecca Dresser, Wanted Single, White Male for Medical Research, Hastings Ctr. Rep. 24, at 24 (1992).
[4] 2U.S. Gov’t Printing Off., Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No.10, at pg. 181-182 (1949) (emphasis added).
[5]Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, The World Med. Ass’n, Inc., (amended Oct. 2008).
[6] International Covenant on Civil and Political Rights art. 7, opened for signature Dec. 16, 1966, 999 U.N.T.S. 171 (1967) (entered into force Mar. 23, 1976).
[7] United Nations Human Rights Office of the High Commissioner, Status of Ratification Interactive Dashboard, Office of the High Commissioner of Human Rights (last visited Oct. 20, 2023).
[8] Id.
[9] Id.
[10] Id.
[11] Lydia A. Bazzano et al., A Modern History of Informed Consent and the Role of Key Information, 21 Ochsner Journal 2021:1 81, 81 (2021).
[12] Id. at 82 (noting that these pivotal patient autonomy cases all had female plaintiffs, “indelibly intertwining the right of patient autonomy with the right of a woman to consent to procedures on her own body.”).
[13] 45 C.F.R. 46 (2023).
[14] See id.
[15] Fuja v. Benefit Trust Life Ins. Co., 18 F.3d 1405, 1410-11 (7th. Circ. 1994) (See 21 C.F.R. § 50 and § 56; 45 C.F.R. § 46).
[16] See Geoff Brumfiel, Why Reports of Menstrual Changes After COVID Vaccine Are Tough to Study, Nat’l Pub. Radio (NPR) (Aug. 9, 2021).
[17] Call for investigation of menstrual changes after Covid jabs, British Broadcasting Co. (BBC) (Sep. 16, 2021).
[18] Id.
[19] Kristine Blix et al., Unexpected vaginal bleeding and COVID-19 vaccination in nonmenstruating women, 9 Sci. Advances 38, (Sep. 20, 2023).
[20] Maheen Nazir et al., Menstrual abnormalities after Covid-19 vaccines: A systematic review, 23 Vacunas 2, at S77, S82 (Jul. 19, 2022).
[21] Id. at S83.
[22] Id.
[23] Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 October 2022, European Med. Agency (Oct. 28, 2022).
[24] Id. (emphasis added).
[25] Blix, supra note 19.
[26] Id.
[27] Id.
[28] 2U.S. Gov’t, supra note 4.
