By Joe Nadglowski, OAC President & CEO
This past week I had the privilege of participating in a set of meetings with several experts in medications used by people with obesity. To be clear, these weren’t medications to treat obesity but were medications often used by people with obesity for the treatment of other conditions. What was shocking is that oftentimes these medications are not fully tested in people with obesity. Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population, but many clinical trials for medications and devices exclude people with larger bodies (especially BMI > 35).
Excluding people with obesity/severe obesity can have real consequences. Perhaps the drug or device will be less effective or perhaps too effective (researchers shared some examples of medication that linger in body fat so may work too well or too long). Long-time OAC member Ted Kyle, RPh, MBA, recently wrote about Rexulti, a medication used for schizophrenia, where the evidence is clear, dosing changes are needed for people with obesity, but neither the manufacturer nor the FDA has yet to take action. This is especially concerning as more than 60% of people with schizophrenia also have obesity.
This made me think, why is this happening? Is this another example of explicit bias aimed at those of us living with larger bodies? The clinical studies process is difficult, and there is a desire to eliminate potential complications, but eliminating people with obesity from participating can potentially cause real harm.
The OAC was formed to give a voice to people with obesity, and we do it every day. Raising our voices about this issue is important. So how do we tackle this issue? Expect more news and actions around this issue in the coming months. We plan on advocating both to the FDA and pharmaceutical manufacturers to make sure their clinical trials reflect the diversity of people living in larger bodies.