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Underrepresentation in Clinical Trials and COVID-19

photograph of vaccine waiting line

There have long been concerns about underrepresentation in the clinical trials of medical products, and there has been a large push for the testing of COVID-19 vaccines to be more inclusive due to the urgency of the problem and danger the virus poses to all of us. The current situation presents an opportunity to assess the previous model that tended to emphasize efficiency — doing the most good for the most amount of people as quickly as possible, often in the interests of speeding production — at the cost to underrepresented groups continually having to use medical products not specifically designed for them.

Historically, both medical professionals and clinical trial participants were primarily men. Making up more than half of the population, women were drastically underrepresented in medicine. This underrepresentation resulted in vast differences in healthcare for men and women. This is important because men and women present different symptoms of disease. Since men have largely been the sample for clinical trials of medical products, there is far more medical knowledge about how men present symptoms of various diseases. This makes diagnosis for women more difficult, and it makes their symptoms seem abnormal.

The underrepresentation of women in clinical trials also impacts the treatment of diseases. When male cells, male animals, and men are the basis of clinical trials, researchers are looking only at the effects on one-half of the population. Often, when women were included in these trials, their data was not analyzed separately or significantly, so differences in experiences were not addressed. After trials, women would take medicine that had not been optimized for them, which could result in negative health consequences. For example, Ambien, a sleep aid, was not tested for differences in effects on men and women. When Ambien became available for use, the slower metabolism of women meant that the drug stayed in their systems longer than men, so the dose was too high for women.

One reason for the low representation of women in clinical trials is that researchers worried that women’s reproductive cycles and hormones would overcomplicate the study and provide confounding variables. However, these variables are part of the reason why men and women both need to be included in clinical trials. When hormonal fluctuations and reproductive cycles are not taken into account, it is uncertain exactly how a medical product will work.

Another reason women were often excluded from clinical trials was fear of harming fertility. In 1977, the FDA recommended  women of childbearing age do not participate in clinical trials for fear that medical products may harm a fetus in the event that the woman became pregnant. This recommendation was put into place after exposure to some drugs caused birth defects. In the past, little research was done about women’s health that did not relate to reproductive health. Fertility seemed to be the primary concern about women’s health, so it was treated as more important than the potential benefits of including women in clinical trials.

The FDA reversed this recommendation in 1993 over ethical concerns about prioritizing the fetus over the potential benefits of including women in clinical trials. The recommendation’s reversal was also related to concerns about autonomy. When the FDA put forth the recommendation, they made it significantly more difficult for women who wanted to participate in clinical trials to do so. Despite some women not wanting children or simply valuing the advancement of women’s health more than any potential negative health effects they may face, women were excluded from trials. The FDA attempted to address safety concerns, but ultimately changed their recommendation because of the constraints on personal choice. While there remain safety concerns, women can now choose to participate in clinical trials.

Due to the urgent nature of the pandemic, ensuring that the vaccine is viable for as many people as possible is a priority. To achieve this, clinical trials have been more inclusive of many medically underrepresented groups, such as pregnant women, minorities, and people with certain medical conditions. Pregnant women can choose to participate in the clinical trials for the vaccine far earlier than they are able to for most medical products. This is partly due to the funding for vaccine development and the higher risk that pregnant women face with COVID-19.

In the future, it is uncertain whether medically underrepresented groups will continue to have the same participation they currently enjoy. While it is clear that these groups ought to have more representation in clinical trials, some medical professionals have concerns about funding and time. Most medical products do not have the funding that the COVID-19 vaccine has. Lower funding limits the number of people who can participate in a clinical trial. Additionally, there are time constraints. When a medical product is necessary, it is important that it is released as soon as possible. Knowledge of the potential health risks for different groups must be weighed with the benefits of releasing the medical product as soon as possible. Often, this means that the human trials consist of healthy men and women with no other conditions being the primary subjects. Later, the effects for individuals with various health conditions may be tested as well, but this is rarely made a priority.

The history of discrimination in clinical trials forces us to consider whether efficiency in the production of a medical product designed for the greatest number of people is truly fair when it means that persistently underrepresented groups continue to suffer from a lack of viable medical products tailored to their particular needs.

Mexico City’s Tampon Ban

collection of feminine hygeine products

On February 9, tampons disappeared from store shelves across Mexico City. The decision to ban tampons was borne out of a larger crusade to eliminate single-use plastics across the city, which since January 1, has abolished plastic bags, straws, and cutlery. Mexico City’s strategy to eliminate tampons is due to the single-use plastic applicators included in the most popular brands. The city decided not to gradually phase tampons out, but instead to impose a ban on sale practically overnight. Though government officials claim this ban was announced far in advance, that did not ease the tension felt by many when they awoke to find the city devoid of tampons.

Was it ethical for Mexico City to ban single-use plastic tampons? Do people who menstruate have an obligation to prioritize reusable products? How can we weigh environmental issues against health and autonomy?

Though evidence of single-use tampons has been documented since at least 3,000 BCE, it was not until 1920’s that the first single-use tampons and pads were mass produced. These single-use tampons first began using plastic in the 1970’s, which some argued made application easier than the cardboard alternatives. The preference for plastic tampons is reflected in North America and Europe, but in many other parts of the world, tampons are devoid of plastic. The advent of accessible menstruation products marked an increase in women’s health and autonomy. Relative access to menstruation health management has been linked to women’s health outcomes and general well-being.

Many criticisms of Mexico City’s tampon ban come largely due to its implementation. For many who menstruate, the convenience of stopping to pick up products when caught off guard is a necessity. As roughly 26% of the world population experiences menstruation regularly, menstrual hygiene has been recognized as a critical human rights issue by prominent human rights organizations such as the Human Rights Watch and UNICEF. Though menstruation is often painted as a women’s rights issue, it is also fundamentally an issue of health. Lack of access to feminine hygiene products has been linked to an increased risk of reproductive and urinary tract infections and urogenital diseases. In many countries in the world, menstruation is still highly stigmatized despite access to products. Additionally, very few countries in the world subsidize menstruation products, instead placing the financial burden on menstruating individuals to cover the cost. With all of these challenges already faced by individuals who menstruate, Mexico City’s decision to eliminate affordable menstrual products stands to exacerbate existing class and sex inequities.

One defense of Mexico City’s ban is the fact that in the long-term, reusable menstrual products are cheaper in addition to being better for the environment. Alternatives such as menstrual cups or even reusable pads save menstruating individuals from having to buy new products every month. However, while these products may be cheaper in the long term for many poor individuals the one-time cost of these products is simply too high as it demands an ability to financially invest in the long term. Those barely able to afford the cheaper disposable products month to month, living paycheck to paycheck or worse, simply do not have the bandwidth to buy these reusable products. The pandemic has also taken a toll on the financial well-being of Mexicans, a country with roughly 10 million people in poverty. Additionally, reusable products are not simply a financial investment in the product itself, but also demand an investment in terms of clean water and cleaning products to properly sanitize these products during usage. The role of clean water in reusable menstruation products becomes even more important when realizing that more than 260,000 homes in Mexico City lack running water. For these reasons, it is not practical nor ethical to obligate menstruating individuals with very little disposal income or access to clean water to switch to reusable hygiene products.

However, putting aside class-based concerns, are those who are capable obligated to switch to reusable menstrual hygiene products? As people had been menstruating hundreds of thousands of years before the invention of single-use plastics, it is clearly possible to menstruate without these products. Depending on one’s access to alternatives, it is arguable that switching to more sustainable menstrual products is part of one’s larger obligation to cut down on plastic consumption generally, especially considering the growing current plastic pollution crisis. However, choosing which menstrual product to use is arguably more than a simple consumer choice. Menstruation is fundamentally a matter of health, and how one approaches it can be deeply personal. There is also something to be said about comfort and preference. Every menstruating individual has a different preference and different products might not be comfortable or feasible depending on their body. With this in mind, menstruation health management is a matter of bodily autonomy. Limiting the types of menstruation products available also restricts an individual’s ability to choose which product works best for them. For this reason alone, some might argue that Mexico City’s decision to outright ban tampons was unethical, as it robbed millions of individuals the right to choose a menstruation tool often relied upon.

The continued stigmatization of menstruation only further demands sensitivity when determining an individual’s obligations in relation to it. While it might be difficult to determine whether reusable menstruation products are obligatory, it might be fair to say that single-use plastics products should be avoided if possible, considering the growing environmental crisis. In many parts of the world, tampons without plastic applicators are widely used. Reusable products have also taken off, and are lauded by many women, reflected in both reviews and in their growing market share. Notwithstanding health and class-based concerns, individuals should explore ways to decrease their consumption impact generally, and one’s choice of menstrual products represents one way to do so.

While an individual may hold an obligation to decrease their waste and consumption, it is another step to justify the government’s decision to outright ban hygiene products without subsidized alternatives. As I have discussed in a previous article, there is a strong argument that governments and corporations bear the brunt of responsibility in addressing the plastic crisis. From this angle, Mexico City’s decision might be viewed as a progressive and necessary step in eliminating its plastic pollution. However, the decision to ban these products without comparably convenient or affordable alternatives could be said to be an injustice in itself, as it greatly impacts the health and autonomy of millions of people who menstruate in Mexico City. And perhaps this tradeoff is not necessary. Those leading the charge against plastic tampons have also largely pushed for government responsibility to provide alternatives.

In what some may see as a great irony, the government officials who led the charge to ban tampons — Mexico City’s mayor, Claudia Sheinbaum, and the director general for environmental regulation, Lilian Guigue —  are both women. In a statement to the Financial Times, Guigue tried to justify the decision by explaining that she had attempted to negotiate with tampon producers to develop alternatives. However, the decision to immediately ban tampons is a reflection of her belief the crisis demanded immediate action.

Environmental issues from climate change to plastic pollution will undoubtedly demand radical consumption changes. Governments around the world, including that of Mexico City, should be aware that a commitment to rapid changes devoid of socioeconomic considerations will unquestionably lead to negative consequences for already marginalized people.

Reconciling Culture and Health in the Debate over Female Genital Mutilation

A photo of an African woman looking out over a field with her baby.

In a thought-provoking posted by CNN earlier this year, Female Genital Mutilation (FGM) is defined as “a brutal practice that’s inflicted on thousands of girls and women.” Female genital mutilation is the process of “intentionally altering” a female’s genital organs for various reasons. It can include partial or total removal of the external female genitalia. There are many moral reasons as to why this practice maybe considered “brutal,” but is it is ethical to portray such cultural practices in a negative light?

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