OW2023: Testing Drugs in People Like Me
“You’re either invisible, or the answer is to lose weight, even with mental health.” This is the sentiment that surfaced at OW2023 in research of lived experiences from people coping with both obesity and needing treatment for mental health concerns. It becomes acutely important as we learn that drug trials for conditions other than obesity often exclude people with larger bodies. When the process of testing drugs for safety and efficacy leaves people with obesity out, significant problems can arise.
Underrepresented in Clinical Trials
Christina Chow heads research for Emerald Lake safety. She explained to STAT News:
“Patients and providers are not aware of how some drugs may act differently in people with obesity. People with obesity are underrepresented in clinical trials for drug approval.”
Today at ObesityWeek, obesity medicine physician Caroline Apovian is presenting a research with Chow, highlighting risks that arise from having incomplete data on people with obesity in drug trials. Their research tells us:
“Over half of studies of investigational products listed on clinicaltrials.gov in 2022 did not mention weight or BMI; when it was listed as an inclusion/exclusion criteria, it was most often used to exclude people with obesity.”
Feeling Invisible
In yet another abstract, Diana Thomas and colleagues analyzed the sentiments expressed in a small series of interviews with people who needed treatment with brexpiprazole (Rexulti), a drug used for treating schizophrenia and depression. They found significant concerns and distress about suboptimal therapy and the lack of consideration for the clinical needs of persons like themselves.
This makes no sense. Why would FDA and Pharma leave such a glaring gap in the testing of safe and effective drugs for persons who represent 42% of the U.S. population? The only explanation we can conceive is the effects of implicit bias, which discounts the lives of heavier persons.
It’s a poor excuse.
Click here and here for the research presentations on this from OW2023. Click here for further reporting from STAT, and here for perspective from Health Affairs Forefront.
People Like Me, still images from patient interviews / Conscienhealth
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October 17, 2023
