Many U.S. Adults May Be Excluded From Weight Loss Drug Benefits
A significant portion of American adults who could benefit from groundbreaking weight loss medications may be ineligible due to stringent trial exclusion criteria. This revelation emerged from a recent study that analyzed the potential reach of these drugs, raising concerns about unequal access and highlighting the need for further research.
Extensive Eligibility, Limited Accessibility
Researchers at the University of Pittsburgh, led by Lily G. Bessette and Timothy S. Anderson, M.D., delved into this issue by examining data from the National Health and Nutrition Examination Survey. They sought to determine how many adults who meet the U.S. Food and Drug Administration’s (FDA) labeling guidelines for weight loss treatment with GLP-1 receptor agonists and GLP-1/GIP receptor agonists would also meet the exclusion criteria established in clinical trials for these drugs.
Their findings revealed a substantial discrepancy. While a large majority—close to 90%—of participants met the FDA’s criteria for treatment with popular medications like liraglutide, semaglutide, and tirzepatide, nearly a third were excluded based on trial eligibility standards. These exclusions disproportionately impacted older adults, with individuals aged 60 and above more likely to meet at least one exclusion criterion.
Common Barriers to Access
The most frequently encountered exclusion criteria included major depressive disorder, malignant neoplasms (cancer), liver disease (specifically for tirzepatide), and uncontrolled hypertension. These conditions, unfortunately, are not uncommon among adults with overweight or obesity, further limiting the potential benefits of these medications for a significant portion of the population.
The researchers emphasize the need for caution when extrapolating the safety and effectiveness of these drugs to populations excluded from pivotal trials. They argue that until robust postmarketing studies provide further evidence, the FDA should revise its labeling to explicitly acknowledge these limitations.
Advocating for Inclusivity and Further Research
“Until there is evidence from high-quality postmarketing studies, the FDA should consider updating labeling to advise caution on generalizing the safety and effectiveness of GLP-1 and GLP-1/GIP to populations excluded from pivotal trials,” the authors stated.
This research underscores the importance of continued investigation into the safety and efficacy of weight loss drugs for diverse populations. Expanding clinical trials to include individuals with common health conditions could unlock valuable insights and pave the way for more equitable access to these potentially life-changing treatments.
Should the exclusion criteria for clinical trials of weight loss medications be reevaluated to ensure broader access to potentially beneficial treatments?
## Many Americans May Be Excluded From Weight Loss Drug Benefits
**[Host]:** Welcome back to the show. Today we’re discussing a potentially concerning issue surrounding access to new weight loss medications. Joining me to break it down is Dr. Emily Carter, a leading endocrinologist and researcher. Dr. Carter, thanks for being here.
**[Dr. Carter]:** Thank you for having me.
**[Host]:** Let’s start with the basics. These new GLP-1 receptor agonists, like Ozempic and Wegovy, seem to be revolutionizing weight loss treatment. But there are concerns that many eligible patients might not be able to benefit from them. Can you explain why?
**[Dr. Carter]:** Absolutely. There’s a significant discrepancy between who the FDA says is eligible for these medications and who was actually included in the clinical trials that led to their approval.
A recent study from the University of Pittsburgh [[1](https://www.forbes.com/sites/tylerroush/2024/11/26/weight-loss-drugs-like-ozempic-would-be-covered-by-medicare-and-medicaid-under-biden-plan/) ]found that while almost 90% of adults in the U.S. meet the FDA’s criteria for treatment, a much smaller percentage would have qualified for the trials themselves due to stricter exclusion criteria. This means there’s a large population who might benefit from these drugs but are being unknowingly excluded.
**[Host]:** What kind of exclusion criteria are we talking about?
**[Dr. Carter]:** It varies by trial, but common exclusions include factors like history of certain medical conditions, use of other medications, and even BMI levels.
This raises serious concerns about equity in healthcare access. Are these criteria truly necessary, or are we accidentally denying treatment to individuals who could greatly benefit?
**[Host]:** That’s a powerful point. This also comes at a time when Medicare and Medicaid are considering covering these medications. Could this wider coverage exacerbate the exclusion problem?
**[Dr. Carter]:** It’s very possible. Expanded coverage is a positive step for making these life-changing treatments more accessible. However, if the eligibility criteria remain restrictive, we risk creating a two-tiered system where only a privileged few can benefit. This highlights the urgent need for further research and discussion about the appropriateness of these exclusion criteria.
**[Host]:** Thank you so much for shedding light on this important issue, Dr. Carter. This is clearly a situation that needs careful consideration and ongoing dialog.
