I have been on a couple of exposes regarding discriminatory medicine in America. See Race-Based Medicine (August 2021); Hippocrates, Harm, Racism (May 2022). I have also been on more than one sidetrack about obesity. How can they Both Increase? (February 2019); I am What I am (July 2013); Obesity Could Kill Me (March 2015). The evidence suggests that there is potential for discrimination in medicine. And there is also an alleged disparate impact of tools like the Boby Mass Index (BMI) on various populations. The BMI Conundrum (August 2022).
These posts point out examples of our modern science coming up short from time to time. We are struggling societally with the challenges of obescity, and the many complications that can bring. People are dying right here in America from the silent killers that are frustrated by, caused by, or exacerbated by the great overconsumption of calories and underactivity of our lives. Some people are fat. Sorry, that is the truth. Some people can change that, and some people cannot. That is likewise the truth. Hard, but the truth.
The USA Today reported last week that there is another wrinkle. This is alleged to result from a blind spot in the manner in which we vet and approve medications in this country. It is 2023 and someone just recently noted that we are not including the obese in the process for testing new medicines. Some contend that 40% of Americans are obese. Our medication approval process is somewhat ignoring 40% of the American population?
USA Today reports that the ignoring of these people in our testing and approval process is resulting in that segment of the population being administered medication at the wrong dose. See, they believe that "it may not be just the extra weight that adds risk." In addition, they now believe that "people with a lot of body fat metabolize drugs differently." The body, is an extremely complex conglomeration of tissues and systems. The critics think that with obesity comes further complexity. The article lists various medications, discusses the science of "fat solubility," and explains that obesity may mean a patient needs a different dose, may retain a dose longer than other patients, or simply may need different attention.
In multiple tests, the researchers have concluded that people "might be getting the wrong amount of needed medication." The medication dosage is set through the clinical trial process. That process, it seems, is focused on a one-size-fits-all paradigm (or a most-sizes-fits-all?). And, in a nutshell, we are not all one size. Is there a reason that children are prescribed different doses? They are generally smaller. They may likewise have different reaction and interaction. That is logical. If the patient's size has potential impact, why not consider this? If the volume of fat cells has impact on the solubility of the chemical, why not consider this?
There is consideration of the needs of children in those trials and research. The researchers contend that there is no (or little) consideration of the obese. And one researcher is blunt about why. He contends that "people don't care about obesity." Perhaps. Or, is it that we do not care about the obese? Are we all a little too quick to judge and condescend? Is there just a little fat shaming in all of us? Are we too ready to think its the cookies, the soda, etc.? Are we conscious of our potential bias?
The article cites examples of people having minimal or no reaction to their medications. There is discussion of the manner in which these chemicals interact with our bodies and produce results that are therapeutic, or not. And, perhaps there is too much tendency to say "well, the package says that dose is appropriate, so let's discount the patient's reported results." What are the downsides for the doctor if she elects to exceed that "appropriate" dose determined by the clinical trial?
There are various perspectives offered. There seems to be one sentiment that would test drugs specifically in this context. That would add a layer of regulatory research and would perhaps cost in dollars and time (getting the product to market and aiding the patient is important). But, others note that there need be no deep dive on every drug. They suggest that instead we could begin by simply asking the question "Oh, would this (weight) be a problem?" within the analysis of a drug.
To be clear, the challenge is not in precluding participation. The obese are not per se excluded from clinical trials, but their presence is not required. That said, some who are obese are excluded because of comorbidities "such as high blood pressure or diabetes," and so there is some suspicion of a resulting absence. Others contend that there is some tendency among the obese to lack faith in the medical profession or in their potential to benefit from treatment. Some perceive that population may harbor some degree of detachment or even resentment resulting from prior medical experiences ("the drugs the doctor gives me do not help").
Thus, there are concerns about treatment efficacy. There are concerns about patient perceptions. And to round it out the quota proponents are seeking to have a government mandate regarding obese participation in drug trials. So, if such a mandate is a good idea, does that mean it is a good idea to forego trials, progress, and potentially life-saving treatments for all if we cannot meet the quota in a given instance? Quotas are perhaps potentially a dangerous path forward.
That said, there are sound arguments presented for testing that includes broader populations. There is likely room for definitions, "best practices," and progress. This might all be accomplished with encouragement, advocacy, and science. The involvement of the government, quotas, and regulation is likely not necessary or advisable.
