- Under representation in clinical trials: If a minority group is under represented in clinical trials, then they will be under helped by the medical progress that comes out of that research. Clinical trials are the raw material from which medical progress emerges. Fewer Black patients in clinical trials now results in worse outcomes in Black patients later, and this damage is done no matter why a minority group is under represented in research.
- Fewer doctor visits and less aggressive treatment by doctors: The most important factor in good results from T1D treatment, is seeing your health care team often, and having a good therapeutic relationship with them. If a patient doesn't visit, or doesn't trust their endocrinology team, then their long term health is going to suffer. Again, it doesn't matter why someone sees an endo less often or why they have less trust. If it happens, then it hurts.
The Patients In Clinical Trials
I've reported on 100s of clinical trials over the last 12+ years. They fall into two groups: the majority, which don't report the ethnic or racial makeup of the people who are enrolled, and a minority which do report, and show that Black and Hispanic patients are underrepresented. Minority groups are enrolled as a much smaller percentage than their population percentage around the recruiting locations.
The whole point of clinical trials is to test treatments on the same people who will eventually end up taking them. The scientific phrase is "representative sample". Therefore, if a study seriously under enrolls any group, that study is not medically effective in testing the treatment. The question of why enrollment doesn't match population doesn't matter in terms of effectiveness of the study. The study is failing its primary goal, regardless of "why".
These are not new ideas. In the end notes section, I discuss the 1979 Belmont Report, which laid the foundation (in the United States) of Justice as a basic requirement for human experiments. It specifically required diversity of participation, so that everyone would benefit from medical research. It is wrong to think that diversity requirements in clinical trials are a recent response or a modern sensitivity. They are long standing requirements.
When I point this out, there are several defensive reactions that should be discussed.
"That doesn't really matter because human bodies react to T1D the same way, so we don't need to include Black Americans or Hispanic Americans to learn how to treat/cure them. Diversity not really needed in clinical trials."
This is wrong for at least two reasons. First, it is arrogant to say that T1D effects all racial and ethnic groups in the same way, to the point where we don't need to include the minority groups in studies. Remember, this is not just saying that, so far as we know, all ethnic groups react to T1D the exact same way. It is also saying that all future research will continue to show this, to the point where we don't even need to do the research in a way which would detect differences! In addition to being arrogant, it is a profoundly unscientific attitude.
Second, a new drug is not just a physical treatment with possible side effects. It is something that people will decide to use in a social context. For example, a CGM device, which only comes in white, might be more comfortable for White people to wear. The exact same device, but in black might have higher adoption rates by Black patients. Testing that includes minorities might find that, but testing that doesn't include minorities will not. Drugs have these kind of social issues as well. A White kid may not care about taking an insulin needle to school. However, a Black kid might need to consider the real danger of police over reaction to this exact same action (even if completely legal, and medically necessary).
"We don't discriminate when recruiting. It's just that fewer minority patients take part in clinical trials."
This argument assumes that the only kind of discrimination is personal discrimination. It assumes if the recruiting process is not explicitly racist, then there is no racism present at all. That is wrong because it ignores both historical racism and institutional racism.
But there is another problem here. This statement is about why there are fewer minorities in the study, and the "why" question doesn't matter in terms of effectiveness of the study. What does matter is that large groups within the population are severely under represented. As an example, if Hispanic patients are not enrolled in a clinical trial, the results will not be as useful to them as to the groups that were enrolled. It is not just the results of that one study, but all future research based on that study will be less useful to the excluded group. The question of why Hispanics (or any other minority) were under represented is helpful to fixing the problem, but it doesn't matter when measuring the size and importance of the problem.
"We're in a White neighborhood, and there just aren't that many minorities near us."
First of all, as I've said above, it doesn't matter. If you plan to publish a study that shows drug X has effect Y, and 90% of your participants are White, then you are really showing that drug X has effect Y in White people. If that convention in writing titles were applied universally in scientific journal articles, the racism would be obvious. The scientific process requires that the people you enroll represent the people you plan to treat. There is no little footnote saying "if you work in an overwhelming White neighborhood then it's OK to test a drug on a non-representitive population".
Also, this thinking assumes that location, as a cause of ethnic exclusion from studies, is an unsolvable act of nature. It's not. Researchers in a heavily White area can recruit at another site more convenient to minorities. They can hire a shuttle, pay for transportation, hire minority recruiters, or advertise in specialty social media where minorities have a strong presence. In short, they could spend extra effort to get a representative sampling of the whole American population. In the past, spending less money to come out with results that were only applicable to Whites was an acceptable thing to do. It shouldn't have been then, and it certainly isn't now.
Furthermore, the location of hospitals and clinics is often the result of systemic enduring racism, in many ways. Rich philanthropists would build hospitals in their own neighborhoods. Clinics and doctors would prefer to build in more wealthy areas with more people like themselves. Even if made decades ago, these clinic location decisions skew research done today. Of course, the existence of ethnic neighborhoods was often shaped by racism in housing, law, banking, policing, and society as a whole.
Managing Type 1 Diabetes
I don't think it is controversial to say that people with T1D have better outcomes when they see their endocrinology team more often, and have a good therapeutic relationship with that team. A good relationship meaning that each side understands and trusts the other, etc.
Recent studies (both in ADA 2020 and previous ADA conferences) show very clearly that Black Americans with T1D visit their endo teams less often than other Americans, that their doctors suggest medical interventions less often, and that (generally) they trust their medical teams less.
The results of these differences are less effective treatments, earlier and worse complications, and higher death rates. Two recent studies showing worse results can be seen here, but there are dozens more:
The first included over 10,000 people and found racial differences even after adjusting for poverty.
The second, of 200+ people found racial differences even after adjusting for insurance coverage.
Changing How I Report On Clinical Trials
Measuring Progress To Decrease Racism
- Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception;
- Beneficence: the philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects; and
- Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally.
The principal of "Justice" required both that minority groups must not be targeted for potentially dangerous clinical trials, nor could they be ignored by potentially beneficial ones. Since all clinical trials are potentially dangerous and potentially beneficial, minority groups should not be over or under represented.
Personal Note: Racism's huge impact and wide effect was "brought home" for me when I was buying my house. It had a covenant prohibiting "any non-Caucasian person" from owning it. This covenant has been unenforceable since 1953, but is still part of the deed of the house, and there is no legal way to remove it. These covenants used to be relatively common in California, especially for single family homes. There are plenty of people alive today who's housing choices were limited by these racist covenants. The banking, policing, and social impact lasted long past 1953. More reading:
I will say that reading these racist housing covenants in a news article is horrible, but reading them in a document you are about to sign as part of buying a house, is even worse. Even though they are completely unenforceable, it made me feel so dirty, so unclean, and to think of the lives they ruined.