We are humans. No matter our gender, race or ability, we are human. We are all made from the same cell types and the same huge DNA blueprint. However, we each express or suppress genes differently creating the diverse world we have today. So why don’t pharmaceuticals represent this?
With the rise in media feminism and a call for equality, it is no surprise that it has taken so long to come to light, but even pharmaceuticals aren’t always accounting for differences between men and women. A recent book (Invisible Women: Exposing Data Bias in a World Made for Men) by Caroline Criado Perez, highlights numerous aspects where women miss out as a result of oversight. As a scientist, the most worrying occurs in pharmaceuticals.
Pharma largely considers the male body as standard. Men and women are both affected by a plethora of diseases and conditions; they don’t discriminate. However, some conditions are more common in one gender than the other: men suffer more from heart disease and Parkinson’s, whilst women suffer more from strokes and osteoporosis for example. Whilst general advice to live a healthy life, avoid smoking etc. is universal, you would expect medications to be tailored and dosed correctly to different genders, no? Unfortunately, there are many clinical trials which have not accounted for gender differences, leading to a much higher percentage of women suffering from adverse drug effects than men. There are other medications women have missed out on, as trials have only targeted men. For example, viagra. This little blue wonder drug was 20 years old in 2018, and earned drug giant, Pfizer, ~$2 billion a year since its release. The same drug (administered vaginally) was tested for period pains, and found to significantly reduce pain for up to 4 hours, doubling the pain relief. Weirdly, this never took off when presented to the all male panel who wanted to keep their blue wonder strictly for the boys. They remarked, “cramps are not a public health priority“...
Other than general gender differences such as weight, fat levels and hormones, another worry is the lack of ethnic diversity in clinical trial groups. In America, ~40% of the population belong to a racial, or ethnic, minority. As well as gender difference, there are differences between ethnic backgrounds, contributing to drug reactions. However, in many clinical trials, 80-90% of patients are white. In 1993, Congress passed an Act requiring researchers to include more women and minorities in their trials, and the number of women did increase. However, in 2014 it was found that fewer than 2% of over 10,000 cancer trials had focused on an ethnic minority. Unfortunately, the 1993 Act does not include all clinical trials.
The trouble comes when we are looking at diseases which affect the minority groups more. For instance, African Americans are more likely to suffer with respiratory problems than white Americans, but in 2015 only 1.9% of all respiratory disease studies included minority subjects. This does not mean that researchers are not willing to diversify their studies, many times minority groups are reluctant to participate or unable to because of financial reasons. Hope is not lost. This year it was announced that multi-million dollar efforts will be underway to close this data gap, in cancer studies at least. There are now multiple studies being conducted to gather information: from cancer genome sequencing of African Americans, to enrolling 10,000 African American men who have prostate cancer to determine other factors which may have increased their risks of developing the disease. Researchers are also starting to re-examine data collected under the labels such as African American or Asian, as such terms actually encompass dozens of countries.
For a large part of the population, we will be fine; we are lucky to be part of a group with lots of research data. However, for those from minority backgrounds, there is still a long way to go. Currently, the FDA (Food and Drug Administration, US) requires drug developers to provide extra testing for drugs which could be used in certain age groups (i.e children or the elderly). This could be rolled into wider requirements, testing for differences between gender, age and race. However, without a larger media storm or public outcry, big pharma may not welcome more money intensive clinical trials. Some drugs can have horrible side effects in some general populations. Such negligence led to the Thalidomide problem.