The Rigged Prescription

Underrepresentation Of Women In Clinical Drug Trials

In 2001, the U.S. Government Accountability Office published a report on drug safety, stating that 80% of the prescription drugs withdrawn from the market had drastically greater health risks for women. These side effects were uncovered only after the drugs had been released into the market. It takes years for a drug to go from being an idea to being tested in a series of clinical trials, and after, a regulatory agency, like the Food and Drug Administration in the USA, ensures that the clinical benefits of a drug outweigh its potential health risks. This long process and millions of dollars in investment are what it takes to get a drug onto the shelves. So how is it that we discover these radical risks to women’s health only after a drug is out for sale in the market?

The Institute of Medicine says that males and females differ at a cellular level. That also indicates that diseases and medicines might affect the sexes uniquely. Still, there’s a prolonged and renowned tradition of disregarding gender when it comes to researches on medical drugs. Using male cells, animals, and then humans have become standard models for medical research.

The significance of heeding the variations amongst males and females in clinical decision-making is critical. However, it has been recognized in recent years that clinical trials consistently have not registered women or examined sex-specific dissimilarities in the data. As these insufficiencies have hampered the passage of recognizing women’s reaction to medications, organizations worldwide have toiled towards the incorporation of women in clinical trials and suitable inspection of gender-specific data from clinical trials.

The Confounding Variable

“We all go to doctors, and we do so with trust and blind faith that the tests they are ordering and the medications they are prescribing are based upon evidence- evidence that is designed to help us.”

Ayson McGregor is an Associate Professor of Emergency Medicine at Brown University, and in her Ted Talk on “Why Medicine Often Has Dangerous Side Effects for Women" she said, “However, the reality is that that hasn’t always been the case for everyone… the medical science discovered over the past century has been based on only half the population.”

Not only do male and female bodies react differently to illness — a detail first observed by Hippocrates amid an influenza breakout more than 2 millennia ago — they also react differently to its treatments. For decades, women have been kept out of clinical drug trials. This expulsion was, in part, due to a “confounding variable” or fluctuating hormone levels in the female bodies that make them harder to research on, as told by Irving Zucker - a professor emeritus of psychology and integrative biology at UC Berkeley - in his study. Ironically, these very fluctuations, body compositions, and metabolisms make the female body more sensitive to certain drugs.

History of the Bias in Testing

Furthermore, till the early 1990s, females of childbearing age were set aside for studies about pharmaceuticals due to medical and accountability worries about subjecting fertile women to medicines and endangering their capacity to bear children -- as was the case in the 1950s and 1960s with thalidomide, which resulted in birth defects of limbs in countless children globally. This thalidomide disaster in the early 1960s underlined the possible harm medicinal drugs could do during pregnancy and led to the opinion that females of reproductive age should be protected from any similar exposure in clinical trials. This resulted in the US Food and Drug Administration (FDA) establishing regulations in 1977 that prohibited women from all medical trials.

In recent years, it has become progressively evident that the reactions induced in a male body do not account for everybody. Evidently, rather than safeguarding females, their expulsion from studies has brought about a generalized evaluation of medicinal effectiveness and side effects, possibly leaving them in danger of significant harm.

In 2014, Roni Jacobson of Scientific American wrote an article on how Psychotropic Drugs Affect Men and Women Differently. The piece highlighted how even though women were banned from clinical trials in the U.S., women were likely to be prescribed psychotropic medication twice as often as men. One of these medications, Ambien, was only later found to be doubly potent for women. Psychotropic drugs are metabolized in the liver, and while the male body breaks down Ambien faster, women retain more of the drug in their system the next morning, hampering their ability to handle heavy machinery or drive. Furthermore, due to a lack of research, there are potential unknown consequences of how these medications interact with birth-control drugs.

To tackle sex-related partiality in medicine trials & research, in 1993 the U.S. Congress issued the National Institute of Health Revitalization Act. It urged researchers to incorporate more females in pharmaceutical drug trials. While this did bring about substantial awareness of the problem and steer the impetus towards gender-balanced clinical drug trials, the job isn’t completed. As late as 2015, the U.S. GAO exhibited the requirement to further study the contrasts encountered by all genders in clinical drug trials. The continued requirement for more incorporation in medicine studies is appreciated.

Why and how should more women be included?

In 2020, it is estimated that more than 300,000 medicinal drug trials begin every year. This speaks for therapeutic chances but also a possible danger for subsets that are not efficiently depicted in medicinal studies. To be dependable and practical, pharmaceutical drug trials need to be both internally and externally justifiable & well-founded. The absence of external validity has generated a demand for more rational “authentic data” tests and the presentation of data that pertains to all classes of patients.

In the age of individualized medicine, there is no room for “one-size-fits-all”. Patients require a treatment that is fitting for various categories, and women and men are different. Gender is an elemental variable that must be used to segregate data and elucidate dissimilarities in treatment consequences. To circumvent this partiality, two principal bases are necessary: incorporation of women in the correct number and right gender-based study.

Conclusion

The under-representation of females in medicinal drug trials comes from the deep-rooted premise that the male standard is the golden standard. Medical textbooks stereotypically default to men in case studies and anatomical drawings, while women are portrayed only in matters about reproductive biology.

Government policies necessitating the involvement of females in clinical drug trials have brought some advancements. They have ensued in the institution of women’s health schemes at numerous government organizations, for example, which has given rise to some substantial successes. Investigators should follow guidelines to ensure the thorough management of subgroup examination to avert deceptive inferences from becoming adopted by medical professionals. Altogether, the incorporation of females and gender-based analysis must carry on to upgrade to secure external validity, decrease gender bias, elude doubt in controlled clinical trials, and save women’s health from drugs that are less adapted to them.