The insufficient representation of medical experiments may lead to the risk of drug safety for ethnic minorities. To promote diversity and equity, experts give advice to medical professionals interested in recruiting diverse subjects.
Do you know that the drugs you take, the medical devices and services you use, are all white men as the main subjects of clinical trials? What problems does this cause?
According to the 2020 U.S. Census results, Gen Z (18 to 24 years old) will be the last generation dominated by whites, and Gen Alpha born after 2010 will be dominated by minorities and become the mainstream of the social population.
However, this is rarely taken into account in the process of collecting samples from medical trials. As of 2011, 96% of genetic disease research was conducted in people of European descent ; Less than 5% of federally funded lung disease research includes subjects or subjects of color .
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The same is a human being, does the race of the recruited subjects affect the results of the experiment?
The answer is: it is. In fact, the fact that the results of the study are not accurate enough because the representative sample is not enough to apply to minority groups may pose great concerns.
The hidden danger of insufficient representative samples
For example, as early as 15 years ago, almost all clinical drug experiments were conducted on male mice. After these drugs went on the market, researchers found that women were twice as likely to experience adverse side effects as men.
As can be seen from the figure below, as of 2009, in the fields of pharmacology and neuroscience, the sum of the number of experiments "using only female animals" and "using both male and female animals" is still less than the experiment of "using only male animals"; Only reproductive medicine experiments use a large number of female animal samples.
Alyson McGregor of the Emergency Department at Brown University gave a talk at TED Short Talk on "Why Drugs Often Have Dangerous Side Effects on Women." Alyson pointed out that according to the US Government Accountability Office (GAO), 80% of drugs are removed from the shelves because of dangerous side effects for women.
The reason behind this is that the cells used for the experiment are all male cells, and clinical trials are mainly male; Most medical research on women focuses on "bikini medicine" such as breasts, ovaries, uterus and pregnancy, and general medical research rarely takes into account gender differences.
For example, the common prescription sleeping pill Ambien has a sleeping effect on men for only about 8 hours, and women may still be confused the next morning, seriously affecting driving and work.
However, the U.S. Food and Drug Administration (FDA) did not recommend a halfway dosage for women until 2013.
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Women's average body shape, hormonal fluctuation range, and body fat rate are all different from men's average. If you want to apply the same set of standards to all individuals, it will inevitably bring unintended consequences.
It can be seen that the inclusion of diverse ethnic groups, the adjustment of the composition of subjects, and the consistency of the ethnic structure of experimental subjects with the population to which the drug is applicable are quite important for the development of medicine and the rights and interests of minority groups.
Possible reasons for the reluctance of minorities to participate in the trial
There are still many hurdles to overcome if minority voices are to be included in scientific experiments.
For example, if this group also happens to be economically disadvantaged or lives in a remote area, the experimenter must take into account variables such as round-trip driving, working hours, and transportation methods, so that the experiment does not affect their daily lives.
In addition to this, medical experiments that specialize in specific races, or recruit high percentages of people of color, may also face the problem of racism.
These experiments may be executed from the ground up with prejudice against minorities, or more likely at the expense of the lives, health, or freedom of minorities for the benefit of the powerful or the advancement of science.
The most famous example is the Tuskegee Experiment, which began in 1932. To study syphilis, scientists at the time recruited 399 carriers of African syphilis in Alabama and promised them free treatment in return for participating in the experiment.
Yet they were not treated. During the study, in order to continuously observe the progression and onset of syphilis, the team only provided placebos such as aspirin and minerals.
Their real goal is to understand the course of the disease until everyone dies, taking laboratory samples and collecting data.
The experiment continued for more than 40 years until it was forced to stop under the reporter's report. But by then, 28 participants had died of syphilis and 100 had died of related complications; At least 40 spouses have been diagnosed with syphilis and it is transmitted to 19 newborn children.
This result not only completely undermines the trust between the African American community and medical researchers, but also greatly increases the difficulty of conducting medical experiments in Alabama in the future, which can be said to have a negative impact on the scientific community and the local community.
How to improve sample diversity in medical trials
If it is difficult to recruit multi-ethnic subjects that fit the proportions of the population, what are some ways to promote diversity? 〈How can medicine achieve more diversity in clinical trials?Emily Moska, author of the article, gives the following reminders to professionals conducting medical clinical trials:
1. Informed consent to ensure the two-way flow of information
At the beginning of the experiment, honestly inform the possible risks, impacts, purpose and expected results of the experiment, and give the subjects the opportunity to ask questions, carefully answer their doubts, and give the subjects the right to leave and refuse to conduct the experiment at any time.
Second, consider the internal culture of the ethnic group and prepare attractive remuneration and compensation
Emily mentioned that when she conducted clinical trials in Zimbabwe, she found that tribal people preferred daily necessities such as utensils to money. Considering each other's preferences and carefully preparing suitable gifts is a demonstration of respect for others and valuing cooperation.
Third, focus on the benefits of experiments and sincerely persuade
Minorities are recruited with the aim of providing better health care.
Researchers should keep this in mind and avoid academic achievement and personal interests taking precedence over the public welfare brought about by medical advances. If this can be effectively communicated to subjects, medical research can appeal to a wider range of subjects in the public interest.
Diversity and inclusion start with medical care
In the past, when medicine was not yet developed, a single group was often used to encompass the entire human race, calculating the effects and risks of drugs and therapies. However, more and more experimental results show that medical treatment should be individualized and tailored, so as not to lead to the unfairness of favoring one over the other.
This spirit is in line with the principle of pluralism and inclusion that "considers the special needs of each individual" and has inspired countless medical researchers. How to see differences in groups of seemingly identical nature, respect differences, and use creativity and professionalism to solve problems is a new vision that needs to be strengthened in the medical field.
As individuals, recognizing that individual differences may bring complexity to the use of drugs and medical devices, we can also express doubts during consultations, propose the need to adjust the dosage or change medications, consult doctors, and assess risks. The doctor-patient relationship is a two-way street, and don't forget that you, as a user of medical products, may be the one who knows your body best.