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In part 1 we looked at the basics of the Look AHEAD Trial of weight loss to improve cardiovascular outcomes. The trial was cancelled 9.6 years into its intended 13.5 year follow up for “futility” when analysis found no statistically significant difference in cardiovascular outcomes between a group that engaged in “intensive” caloric restriction, exercise, and, in some cases, diet drugs, and a group that got three counseling sessions a year about diabetes management.

One of the claims that I often see people make is that the group that maintained at least a 10% loss had better outcomes. We saw this recently in the write-up of the Foundayo trial, in which they claimed, without context that “patients who had a weight loss of 10% or more through a lifestyle intervention had a 21% reduction in cardiovascular events.” I mentioned in that piece that this was an analysis of a small subgroup. There are some real caveats around this and other claims about the 10% weight loss group so let’s dig into it.

For this we’ll look at “Four-year weight losses in the Look AHEAD study: factors associated with long-term success” by Wadden et al.

As always I’ll indent the quotes so you can skip the weight stigma. In their writing ILI is the abbreviation for the weight loss group and DSE is the abbreviation for the control group.

In general they discuss the weight loss:

“At year 4, 35% of ILI and 18% of DSE participants achieved the study-wide goal of losing ≥7% of initial weight (P < 0.0001), and 23% and 10%, respectively, lost ≥10% (P < 0.0001).”

Said another way, the study goal was to produce weight loss of just 7% or more of body weight and 65% of the people who were subjected to these “intensive” interventions including diet drugs didn’t hit even that modest goal. Also, 23% of the ILI group lost 10% or more of body weight, but 10% of people in the control group that didn’t do any of these interventions did so as well.

This again raises questions about the necessity of such extreme restriction even for people who believe that weight loss creates health benefits (which, again, this study does not show, since there is no way to determine if any health differences are from weight loss or behaviors, and research that actually sought to answer that question found no relationship between small amounts of weight loss and health changes in correlational analysis, and posited that it was more likely that behaviors, social support, and engagement in the healthcare system were likely to be driving the health outcomes.)

The authors of the Look AHEAD paper also point out that:

“significantly more DSE than ILI participants (45% vs. 26%) had gained above their baseline weight at year 4 (all P values < 0.001)”

What they aren’t being clear about is that the DSE (control) group had modest weight gain from baseline while not participating in a weight loss intervention. Meanwhile, just four years in, more than a quarter the ILI (intervention) group weighed more than when they started. Now, there is nothing wrong with being higher-weight or gaining weight, but I would say that there is something seriously wrong with a so-called healthcare intervention that subjects people to “intensive” food restriction, physical activity, and diet drugs and then has the opposite of the intended effect for at least 26% of the participants. This particularly does not age well given that we now know that the intervention would be cancelled for futility for failing to impact the intended health outcomes.

When it comes to the group who lost 10% the Look AHEAD authors write that:

“[Figure] 3 shows 887 ILI participants who lost ≥10% of initial weight in the first year and shows the number of these participants who achieved a loss of this size at year 4 (N = 374) or, alternatively, maintained losses of 5.0–9.9% (N = 251), 0–4.9% (N = 174), or gained above their baseline weight (N = 88). As shown, fully 42% of this subsample achieved a loss ≥10% at year 4, and a total of 70.5% maintained a loss ≥5%.

It should be made clear that “fully 42% of this subsample” refers to 42% of 35% of the original sample. So out of the 2570 original people in the intervention arm, 887 participants (about 35%) lost ≥ 10% at year 1. But at year four, only 374 (about 14.5% of the original group) were still at 10%.

Percentage wise, that means fewer than half of the people who had lost 10% or more of their body weight in the first year were still at or over 10% by year four and that, overall, only about 15% of the total group managed 10% weight loss for even 4 years. But there is more to this story, let’s look at their Figure 3A that shows the weight trajectory of this group:

Image text: Figure 3 A. Weight loss trajectories over 4 years in the 887 participants in the Intensive Lifestyle Intervention (ILI) who, at year 1, lost ≥ 10% of initial weight. The figure shows the number of participants who, at year 4, maintained a loss of 10% or more of initial weight (N = 374), of 5.0–9.9% (N = 251), or of 0–4.9% (N = 174) or who gained above their baseline weight (N = 88).

You’ll note that everyone has regained from their low point, 9.9% (88 people) had already regained more weight than they lost and the majority are still on a trajectory to continue to gain weight after this follow up.

If we go back to their quote, they claim that this figure shows percentages of people who “maintained losses of 5.0–9.9% (N = 251), 0–4.9% (N = 174).” I do not think that the word “maintained” reflects the reality that these people’s weight trajectory is going straight up. Catching a group of people at 5% weight loss on their way up is not the same thing as “maintaining” a 5% weight loss.

Content note: This next section talks about calories, exercise, disordered eating/eating disorders, if that may be harmful to you you can scroll down to “Discussion.”

The researchers note that

“Participants who maintained the [10%] loss, compared with those who did not, attended more treatment sessions and reported more favorable physical activity and food intake at year 4.”

Again, this begs the question as to whether behavior or weight loss actually created any health difference. It also begs another, much more troubling question. Below is their Figure 4 which shows the characteristics of the subset of subjects who took self-reported surveys about their food and exercise behaviors. Note that those who maintained a 10% loss in general were consuming about 1565.5 calories a day (fewer than the 1,570 calories subjects in the Minnesota STARVATION study were given during the starvation stage) and burning about 2,000 calories weekly through exercise. Applying the Paffenburger Activity Questionnaire that these authors are using to the Minnesota STARVATION study participants, those participants were expending about 2200 calories per week. One thing the authors don’t mention in this sub analysis, or the original analysis, is the possibility that they created disordered eating/eating disorders in part of their population and then celebrated it as “long-term success.”

Discussion

The first sentence of their discussion section states:

“Participants in the Intensive Lifestyle Intervention achieved a 4.7% reduction in initial weight at year 4. This loss is among the largest reported at this length of follow-up for individuals in a randomized controlled trial who were treated by a lifestyle intervention”

I do not think that this is the flex they think it is. Giving people less food and similar activity to a study on starvation over four years produces 4.7% weight loss - an amount of weight that some people fluctuate monthly through their menstrual cycle? The phrase “who cares?” comes to mind.

To further demonstrate the issues with this study, in the discussion section these authors compare their “maintainers” to the National Weight Control Registry which I have discussed before as perhaps the worst example of the truly ridiculous methodology that passes for “science” when it comes to weight loss and health.

In general, when people cite the Look AHEAD study as proof of efficacy of weight loss interventions, you can suggest that they look back at the actual findings of the study. Even these authors are honest that “Look AHEAD’s study design prevents us from definitively determining the contribution to long-term weight loss of the lifestyle intervention’s different treatment components.” What they aren’t so clear about is that Look AHEAD’s study design prevents them from knowing if weight loss had anything to do with any of the health benefits.

Especially since, as we talked about in part 1, research finds that weight-neutral interventions can produce similar or greater benefits with less risk.

In general, whenever someone claims that a study shows that weight loss creates health benefits, the first question you can ask is “what mechanism was used to determine whether weight loss or behavior change created the differences in outcomes?” If there isn’t one, then they can’t conclude that weight loss did anything at all.

If you want to learn how to read between the lines of weight and health research, this month’s online workshop is about exactly that. I’ll teach you the basics of breaking down research and analyzing media article and social media to break through the BS and get to the truth of what the research finds (and what it doesn’t). There is a pay-what-you-can option so money isn’t a barrier and all registrants get a video. Details and Registration here!

If you appreciate the work I do here, you can support my ability to do it by becoming a free or paid subscriber!

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

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People make a lot of claims that the Look AHEAD trial offers some sort of support for the efficacy of weight loss diets. So in this two-part series we’re going to look back at the LookAHEAD trial - what is was, what it found, and what it didn’t.

I’m going to start with the trial they registered at ClinicalTrials.gov (Note that the link includes weight stigma.) As always I’ll indent the quotes from the study, you can skip them and still get the basics of the piece.

They described the study thusly:

“The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overw*ight or ob*se.”

I interviewed two prominent researchers who were working in the field at the time of the trial anonymously about this and they both explained that at the time, while there were studies showing links between weight loss and cardiovascular risk factors like blood pressure and cholesterol (though I’ll add that those studies failed to have a mechanism to determine if weight loss or behavior changes were actually the cause of the health changes,) the existing studies were just looking at risk factors, not actual outcomes. Look AHEAD was designed to see if weight loss impacted actual outcomes. The people I interviewed explained that the Look AHEAD researchers had chosen people with T2D because there was a higher likelihood of cardiovascular events and thus a higher likelihood of statistically significant results.

Just like essentially all studies about weight loss and health, this trial was fatally flawed from the start because, while the intervention was based on behaviors, there was no mechanism to determine if it was the behavior changes or the weight loss that was actually responsible for any health changes. Research that actually sought to answer that question found no relationship between small amounts of weight loss and health changes in correlational analysis, and posited that it was more likely that behaviors, social support, and engagement in the healthcare system were likely to be driving the health outcomes.

Look AHEAD compared an “intensive lifestyle intervention program” (the standard “eat less, exercise more” taken to an extreme,) to a control group.

Subject Groups

(Content note: The “Lifestyle Intervention” includes discussions of restriction, disordered eating, and specific caloric intake that may be triggering. You can skip that by scrolling to “The Diabetes Support and Education Group”)

The “Lifestyle Intervention”

From ClinicalTrials.gov:

“Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.”

Let’s talk more about this “intensive” lifestyle intervention. Per “Four-year weight losses in the Look AHEAD study: factors associated with long-term success” by Wadden et al., during the first year, participants were allowed only 1200-1800 calories a day which was calculated based on their starting body weight (as a reminder, the Minnesota STARVATION experiment participants got 1,570 calories per day). In order to “induce weight loss during the first 5 months” participants were subjected to the “intensive use of meal replacements [and] structured meal plans.” and “During months 5–12, participants were encouraged to continue to replace one meal and one snack per day with liquid shakes and meal bars.” In terms of physical movement, “Participants were given an activity goal of “≥175 min/week of moderately vigorous physical activity, to be achieved by month 6, with a further increase for participants who met this goal.”

This is probably the least of my issues with this, but I feel the need to say that I’ve held fitness certifications since 1996, I currently hold certifications as a health coach, group exercise instructor, functional training specialist, fitness nutrition specialist, and size inclusive fitness specialist (shout out to Louise Green who created that cert for ACE Fitness) and I can confidently say that I’ve never been given a definition for what constitutes “moderately vigorous” physical activity. There are definitions for light, moderate, and vigorous activity based on everything from perceived exertion to METS but moderately vigorous…that’s a new one for me.

During years 2-4, “the focus of treatment shifted to maintaining the weight losses and high levels of physical activity achieved during the first year. Those who had not achieved the recommended goals were encouraged to do so.” The participants were subjected to monthly individual lifestyle counseling sessions and “individualized calorie goals” but “All participants were encouraged to replace one meal or snack per day with liquid shakes or meal bars.” Finally, “All sites provided a monthly group session at which participants weighed-in, reviewed any diet and activity records they had completed, and then listened to a presentation on a new topic on lifestyle modification.”

Orlistat (a weight loss drug) “was offered to individuals who failed during the first 6 months to meet the study’s weight loss goals (or subsequently regained weight). However, orlistat was largely discontinued from the trial in 2008 based on findings that it was of limited benefit as a rescue strategy”

So that’s…a lot. Let’s look at the control group.

The Diabetes Support and Education Group

“The diabetes support and education arm provides group sessions on diabetes management and social support. Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.”

This is a truly ridiculous comparison. One group is having to choke down shakes and bars and show up for at least monthly individual sessions and group presentations and the other group received generic advice three times a year? Way to stack the deck!

I want to point out again that not only was this trial not designed to figure out if behaviors or weight loss was responsible for any outcome differences, if it was the behaviors, there was also no way to know if people needed interventions this “intense” to get the health benefits.

Study Hypothesis

Their primary hypothesis was:

“that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, hospitalized angina, and non-fatal stroke, over a planned follow-up period of up to 13.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition, Diabetes Support and Education.”

Rather than testing the outcomes individually, they decided to use a composite outcome which means instead of testing the first occurrence of cardiovascular death or non-fatal heart attack or hospitalized angina, or non-fatal stroke, they tested for the first occurrence of all of those combined. Like choosing a study population with T2D, this choice also boosts their chances for getting statistically significant results.

They planned for the trial to last 13.5 years.

There were a total of 5,145 people, with 2,570 in the intervention group, and 2575 in the control group. When the trial was ended 89 people had dropped out of the intervention group and 99 had dropped out of the control group. Though it’s important to note that staying in the trial and actually adhering to the requirements are not the same thing.

What did they find? Let’s look at the results from the published article by the trial authors:

“The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51).”

In other words, their hypothesis was wrong, even with the use of participants with T2D, the vast difference between the intervention and control group, and a composite outcome to increase the chances of statistically significant findings, there was no significant difference in cardiovascular outcomes between the lifestyle group and the control group. The study was cancelled 9.6 years into a 13.5 year planned follow up - for futility. Also, notice that the average weight loss went down between year one and study end, suggesting that weight was being regained.

While I think there is something morally wrong with research that creates these kind of “intensive” restriction interventions, there is nothing wrong with having a hypothesis disproven. Not being able to reject the null hypothesis is still good data. That said, these authors really seems to go above and beyond to try to snatch support for weight loss out of a study cancelled for futility.

They claim, for example, that those in the weight loss group experienced “reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors,” so let’s talk about that.

Research around weight-neutral behavioral interventions, including Matheson et al., Gaesser and Angadi, and Weeldryer et al, and Bacon et al. have found that these improvements can be made without weight loss and certainly without “intensive” lifestyle interventions and diet drugs. Meaning it’s likely that people could have done a whole lot less restricting and diet drugs (and avoided the risks that come with that including disordered eating and eating disorders, which this study did not include in its adverse events) and gotten similar benefits. This is why I think it’s so important to have weight-neutral comparator groups.

Speaking of adverse events, there were slightly more serious adverse events in the lifestyle intervention group (24.86%) than the control group (23.15%). In the lifestyle intervention group there were slightly higher rates of congestive heart failure (3%/2.91%), amputations (1.09%/0.78%), gallstones (2.06%/1.90%), and all fractures (17.74%/15.69) than in the control group. (I’m curious especially if the difference in fractures may have been due to malnutrition in the intervention group.)

Finally, they claim “These results provide critical evidence that a comprehensive lifestyle intervention can induce clinically significant weight loss (i.e., ≥ 5%) in ov*rweight/ob*se participants with type 2 diabetes and maintain this loss in more than 45% of patients at 4 years.”

That is quite the conclusion. They are ignoring that, even by their incredibly meager definition for weight loss, more than half the participants weren’t able to achieve it. They are ignoring a decrease in the average weight loss over the study period. They are working hard not to provide a definition for clinical significance. They are sorta kinda defining it as 5% or more weight loss, but this study found that this amount of weight loss did not improve outcomes, so clinically significant for what, exactly?

Maybe you’ve heard that those who lost 10% of body weight had better results? We’ll discuss in Part 2.

Want to learn how to read between the lines in weight and health research? This month’s online workshop is Truth, Lies, and Measuring Tape - Reading Between the Lines of Weight Loss Research. I’ll will teach you the basics of breaking down research and analyzing media article and social media to break through the BS and get to the truth of what the research finds (and what it doesn’t) and what that means for how the research can (and can’t) be applied to real life. This workshop is for everyone - from research newbies, to research nerds! There is a pay-what-you-can option so money isn’t a barrier and all registrants get a video. Details and Registration here!

If you appreciate the work I do here, you can support my ability to do it by becoming a free or paid subscriber!

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

I have waited for five years to write this post and I really cannot tell you how excited I am about it!

Summary

Over the past five years the Weight Inclusive Toolkit Initiative (WITI), a group of over 100 people with professional and lived expertise, most of whom have marginalized identities, have engaged in thousands of hours of labor to create the first standardized weight inclusive curriculum toolkit for nutrition and dietetics education, mapped to the 2027 ACEND standards and absolutely free for all educators, preceptors, students, interns, practitioners, and anyone in any field who is interested in weight inclusive tools.

I’ll tell you all about it but first, in case you are in a hurry, you can sign up to receive the toolkit here. You just fill it out to have the toolkit sent to you and, optionally, you can choose to join the Learning Community to have future information sent to you about things like learning opportunities including a monthly self-study module (with CPEUs) at no charge, and more!

Please also feel free to let others who might be helped know about the toolkit. A ton of time and labor went into it and now it’s time to get it out to the people who can help with it and be helped by it!

Deeper Dive

I am proud, honored, and humbled to have been part of WITI almost from the beginning as part of the governing board and as part of the Counseling Case Study content group.

The Weight Inclusive Toolkit was developed over five years through a
unique, community-driven process. Community members and leaders with lived experience, as well as RDNs, dietetics educators, preceptors, program directors, students, interns, and health professionals all contributed to the content. I will include more specifics about the process below. I will also say that I have personally learned and benefited so much from being part of this process and I am grateful.

Toolkit Contents

All of the toolkit’s lectures, webinars, and case studies are already pre-mapped to the new ACEND 2027 accreditation standards, saving valuable time for dietetics educators and preceptors when planning curriculum.

The contents include:

• Weight Stigma and Bias

• Defining Weight Inclusive Care

• Eating Disorders and Disordered Eating

• Expanded RDN Skill Set:

  • Screening and Treatment of Eating Disorders and Weight Cycling prior to Medical Nutrition Therapy (MNT)

• Creating Safe and Inclusive Classrooms

• Case Study Presentations:

  • Counseling clients from diverse communities

  • Weight Inclusive Medical Nutrition Therapy (MNT)

  • Supplemental case study questions for all MNT diagnoses

There are over 20 Lessons and Case Studies that include:

• Lesson Plans

• Webinars

• Lecture Slides

• Experiential Activities

• Homework Assignments

• Resources: books, podcasts, videos, websites, etc.

Additional Resources Include:

• Hundreds of Weight Inclusive Tools and Resources

• Multiple Research Libraries and an Annotated Bibliography

• Self-Study Educator/Preceptor Training Modules:

  • Meet continuing education requirements (CPEUs) for health equity and ethics from the Commission on Dietetic Registration (CDR)

While the toolkit is focused on Nutrition and Dietetics Education, I can tell you that it is has wide applicability beyond the Nutrition and Dietetics field.

Before we get into the toolkit creation process, a reminder that the toolkit is available at no cost and you can sign up to receive the toolkit here.

Toolkit Creation Process

Here is more about the process of creating the toolkit from the WITI document “The Weight Inclusive Toolkit: Foundations, Development and Dissemination” and with gratitude for early consulting from Jessica Wilson, MS RD.

The mission of the Weight Inclusive Toolkit Initiative (WITI) is to prevent harm to millions of patients/clients by educating thousands of future and current health professionals about weight discrimination, weight-inclusive care, and the intersection with the oppression of other marginalized identities.

The WITI governing board, committee, and consultants include fat advocates and RDNs across multiple practice areas who have advanced the field of weight stigma and eating disorders. In addition, community members with lived experience, dietetics professors, program directors, preceptors, researchers, students, interns, and other health professionals all contributed to the creation of the toolkit.

The majority of contributors have underrepresented identities, including people in larger bodies; Black and Indigenous people of color; LGBTQIA+ individuals; people with disabilities or neurodiversity; people with chronic diseases; and people from diverse religions and cultures, and they bring both lived and professional experience with the toolkit’s content. Multiple perspectives were incorporated throughout the development process, and the governing board collaboratively held authority for all project decisions. These diverse voices ensure that the toolkit reflects the communities it is designed to serve and integrates both lived experience and evidence-based care in weight-inclusive approaches.

WITI reached out to organizations such as the National Association to Advance Fat Acceptance (NAAFA), the Association for Size Diversity and Health (ASDAH), and Fighting Eating Disorders in Underrepresented Populations (FEDUP): A Trans+ & Intersex Collective, which provided referrals for consultants with lived experience from the client’s perspective. Organizations such as EDRD PRO, Weight Inclusive Nutrition and Dietetics (WIND), Weight Inclusive Dietitians in Canada (WIDIC), and Medical Students for Size Inclusivity (MSSI) provided webinar donations/resources to help fill in some of the gaps in the content.

WITI also had sharing circles so that the content was reviewed by the whole committee, which included many perspectives from a diversity of identities and lived experiences. In addition, the webinar presenters all had lived experience related to the content they were presenting.

WITI was very intentional about taking enough time to prepare the toolkit and not rushing into content creation, which could have caused additional harm. WITI incorporated a recruiting phase and prep phase prior to content creation, without having a sense of urgency or expecting perfection with the end result.

WITI prioritized self-care for all members (participation was based on their capacity, and self-care reminders were incorporated during meetings). The board approved community dialogue guidelines and a repair process to help create an accountable space and minimize harm. When harm was caused (i.e., there was not enough representation or enough funding at the beginning of the project’s recruiting phase), the project manager took accountability, was transparent with everyone about what occurred, and took steps to repair the harm (i.e., establishing a governing board to make decisions, applying for more grant funding, etc.).

WITI established community dialogue guidelines, completed education, self-reflection, and sharing circles about topics such as racism, gender-affirming care, ableism, food insecurity, weight stigma, inclusive language, et cetera, to help members identify any biases prior to content creation. All committee members and interns completed the education and sharing circles as part of the preparatory phase of the project, and new members receive education about these topics as well.

WITI meetings also use check-in questions to promote fun, bonding, and commonalities among people from different identities.

WITI incorporated a very thorough review process, which included sharing circles to review the content (perspectives were provided from people with a variety of identities). The review process of the toolkit incorporated content reviewers and webinar presenters with lived experience and/or professional experience. The review process included: review by community leaders, fat activists, and scholars with lived experience of weight stigma, RDN/health professional review, community member review (client’s perspective), inclusive language review, continuity review, and accessibility review.

All content was reviewed using an accessibility checklist, which includes checking for accessible font sizes, alt text for visuals, accessible font type (i.e., sans serif), accessible color combinations, contrast of colors, accurate closed captions for the webinars, etc.

WITI offered payment to all webinar presenters, content reviewers, and client/lived experience reviewers for the toolkit. WITI offered additional honorariums to the presenters of the webinars, which were donated from WIND, EDRD Pro, and WIDIC. WITI also offered funding for lived experience library stories from clients and to the panelists who discussed the project at various conferences. Funding for content creators is still needed.

In addition, WITI received an offer to translate the toolkit into Spanish and adapt the toolkit for use in Mexico as part of a large university system with over 35 campuses in 25 cities in Mexico. After the toolkit is translated into Spanish, it would be shared with dietetics students and high school students who are taking nutrition courses for college credit at this university system.

WITI also has board members who are Canadian RDNs, and we are currently looking for Canadian grants or research grants to be able to adapt the toolkit for use in Canada. Applicable parts of the toolkit will also be shared with the public and RDNs on the website of the Weight Inclusive Dietitians in Canada (WIDIC).

I’m so proud to have been a part of this project and honored to be part of the incredible team that created it!

If you appreciate the work I do here, you can support my ability to do it by becoming a free or paid subscriber!

Subscribe now

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

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In Part 1 we began talking about the ATTAIN-1 Trial for Eli Lilly’s new GLP-1 weight loss pill Foundayo including the study basics. Today we’re going to look at the study discussion, which is where the authors (all of whom we learned in Part 1 are either taking money from Eli Lilly or employees/stockholders of Eli Lilly) give their interpretation of the results. As always I’ll indent the quotes from the original study, you can skip them and still get the gist of the piece.

In this phase 3, multinational trial, we compared three once-daily doses of orforglipron (6 mg, 12 mg, and 36 mg) with placebo in 3127 patients who had ob*sity without diabetes.

Here we see the stigmatizing, weight-loss industry driven use of “person first language” as part of their goal of diseasifying simply existing in a higher-weight body. Also, they started with 3127 people but only 2344 patients actually completed the administration of the drug or placebo across the trial.

After 72 weeks of treatment, all the patients in the three orforglipron groups had a significant and clinically meaningful dose-dependent reduction in body weight.

They are claiming “significant” and “clinically meaningful” but they are not defining either of those things, nor do they provide any evidence that the weight loss was what was clinically meaningful in terms of health improvements (as opposed to any benefits possibly stemming from behavior change and/or the mechanism of the drug itself.)

The patients who received the highest dose of orforglipron had an average 11.2% weight reduction; more than one third had a reduction of at least 15%, and nearly one fifth had a reduction of at least 20%.

Said another way, the patients who received the lowest dose of the drug had an average weight loss of 7.5% body weight and less than 20% of patients lost 20% or more of body weight (we went over the specifics in Part 1.)

All measured cardiometabolic biomarkers improved with orforglipron treatment as compared with placebo.

The placebo group and the drug group both experienced cardiometabolic benefits, the benefits were a bit higher with the drug groups but here again, it’s unclear whether that was due to the drug itself, behavior change, or weight loss.

Here I want to come back to something I mentioned in part 1, which is their choice to pool all the drug groups together to discuss these other supposed health benefits. That doesn’t make sense to me. People aren’t taking an average of multiple doses, they are taking a specific dose, so why not talk about the doses separately, as they do for weight loss? My guess is that they are trying to obfuscate the overlap between the drug groups and the placebo group, but that’s just a guess.

Weekly injectable incretin-based ob*sity therapies, such as semaglutide and tirzepatide, have resulted in mean weight reductions of approximately 15% and more than 20%, respectively. A weight reduction of 10% or more is a recognized therapeutic threshold, one that has been linked to meaningful cardiometabolic benefits.

I feel like this is where we really start to see the impact of having people who are financially entangled with the drug company writing up the trial. First of all “ob*sity therapy” seems to be another strand of spaghetti thrown on the wall in the endless game of trying to rename weight loss drugs for the benefit of weight loss industry marketing campaigns.

Let’s talk about this claim of 10% weight loss as a therapeutic threshold linked to meaningful cardiometabolic benefits. First, “linked” is doing a lot of work here and we should remember that it means “happens at the same time” and not “is caused by.” To support it they cite two papers that don’t consider the confounding variable of behavior changes, one from 2016 and one from 2017. What they don’t mention is that in 2013, before either of those papers were written, researchers actually investigated this 10% weight loss claim and found that, in correlational analysis, there was no connection between weight loss and health benefits, positing that it was likely things like behavior changes, access to healthcare, and support that drove health changes, which is supported by research around weight-neutral interventions.

In our current trial, patients who received orforglipron had a mean weight reduction of as much as 11.2%, and such reductions were associated with improvements in systolic and diastolic blood pressure, as well as lipid, glycemic, and high-sensitivity C-reactive protein levels. Although differences in design and population preclude direct cross-trial comparisons, these cardiometabolic improvements were similar to those reported with oral and injectable semaglutide in ob*sity trials, despite the modestly lower weight loss in the current trial, a finding that reinforces the clinical significance of a weight reduction of 10% or more.8,16

Wait, what? They admit that the actual health benefits associated with this GLP-1 drug were similar to other GLP-1 drugs despite the fact that significantly less weight was lost. Instead of at least acknowledging that this could mean that the health changes are driven by something other than weight loss, they conclude that it reinforces the 10% threshold that was created not through clinical trials but by the weight loss industry reducing the number to something that they could achieve, at least for a short time? I know I talk a lot about the author conflicts of interest (again, see part 1) so I do want to make it clear that I’m not necessarily saying that people are churning out bad research for money (though I do believe that there are some people doing that,) but there is also the possibility of interpretation and conclusions being guided by paradigm entrenchment. When the only tool you have (and the only tool you are open to believing exists) is a weight loss hammer, then every problem is a body size nail.

In the Look AHEAD trial, which included patients with type 2 diabetes, patients who had a weight loss of 10% or more through a lifestyle intervention had a 21% reduction in cardiovascular events.

It should be clear that this is a sub-analysis of a small part of full Look AHEAD study population and there was no mechanism by which to determine if it was actually weight loss or if behavior change created the difference.

Similarly, in the SELECT study, a cardiovascular outcomes trial involving patients with ob*sity without diabetes, a 9.4% weight loss with semaglutide over a period of 2 years was associated with a 20% reduction in major adverse cardiovascular events.

I think this is particularly misleading since the SELECT authors were honest that the cardiovascular impacts (which were actually a 1.5% absolute risk reduction that was only statistically significant for white cis men and Asian men as a composite who were between 55 and 75 with a BMI below 35) happened before much weight was lost.

GLP-1 receptor agonists may improve cardiovascular outcomes both by inducing weight reduction and by their direct, weight-independent actions.17 Whether orforglipron-induced weight reduction and biomarker changes will translate into a reduction in cardiovascular risk requires dedicated outcome trials.

I would argue that it also requires trials where the idea that weight loss is going to get the credit isn’t a foregone conclusion and where the study authors aren’t willing to tie themselves, and their data, into knots to come to that conclusion.

Clinically, weight-reduction targets are individualized. Treat-to-target approaches that are based on thresholds of BMI or waist-to-height ratio have recently been proposed, although a single defined target remains a matter of debate.

None of this comes anywhere near saying there is evidence that actually supports a goal weight as an appropriate target for healthcare. I would argue that is on purpose. We’ve seen how hard the weight loss industry is working to create the most favorable “diagnostic criteria” for the construct of “ob*sity” (that they have made up) and continue to manipulate to create an ever-expanding market and profits.

Results of exploratory analyses in the current trial suggested that patients who received orforglipron had a higher likelihood of having a normal BMI or a near-normal waist-to-height ratio (<0.53) than those who received placebo, particularly among patients who had class I ob*sity or a BMI of 27 to 30 and associated complications at baseline.

And now a message from Captain Obvious. People who take a diet drug whose weight is close to an arbitrary threshold are more likely to (at least temporarily) reach that arbitrary threshold than people whose weight is farther from that arbitrary threshold. Also, they snuck in that “associated complications” line which brings us back to the made-up idea of “ob*sity-associated” health issues which are health issues that people of all sizes get that get called “ob*sity-associated when higher-weight people have them.

As with other ob*sity-management medications, weight-reduction responses varied substantially; notably, nearly one fifth of patients who received the highest dose had a weight reduction of at least 20%. We speculate that these findings may hold particular clinical relevance for patients with lower BMI values (for example, <35), who constitute the majority of patients with excess adiposity.

I would argue that this is far less scientific language, and much more marketing language. What they seem to be trying to gloss over is that this weight loss drug created less weight loss than other GLP-1 drugs, so they appear to be trying to stake their claim to the market of people with BMIs lower than 35.

Furthermore, orforglipron could represent an effective option for many patients, such as those who prefer oral therapy or lack access to injectable peptide-based ob*sity-management medications, including those in low- and middle-income countries where access is limited owing to low cold-chain availability.

Here again, they are making a marketing claim, not making a scientific claim.

In a phase 2 trial involving patients with ob*sity, 36-week treatment with 12 mg or 36 mg of orforglipron per day led to a substantial reduction in body weight, a loss that did not appear to plateau.

Did not appear to plateau? Seriously? Let’s examine the situation. This is their own Figure 1B showing “change in body weight from baseline to week 72”

Not only did the weight loss plateau in every group by week 48, in the 12mg group weight was going back up and was still trending up, at the end of the trial.

Despite the longer duration of the current trial, weight reduction after 72 weeks was similar to the reduction at 36 weeks in the phase 2 trial. Reasons may include differences in trial design and population, including greater geographic diversity in the current trial than in the phase 2 trial. Also, in the current trial, we enrolled a higher percentage of men than in historical phase 3 ob*sity trials, a factor that limits cross-trial comparisons, since men are reported to have less weight reduction than women in response to incretin-based treatment.

So what they are saying is that the more representative the trial is, the lower the weight loss over time? Not a great look. Going back to their graph, the 6mg and 12mg did basically plateau at 36 weeks and, of course, that doesn’t account for the dropouts which you can see by looking at the numbers at the bottom of the graph, and which we discussed in part1.

Variability in responses to ob*sity-management medications is well documented and not fully understood.20 In this phase 3 study, a healthy, balanced diet, rather than a hypocaloric diet with a 500-kcal deficit, was implemented as part of the recommended lifestyle modifications in line with recent expert recommendations. It remains uncertain whether this regimen influenced the trial results.

Now it’s “ob*sity management” medication? The first part of this paragraph is damage control. This drug doesn’t offer a lot of weight loss comparatively, so they don’t want to use a term like “anti-ob*sity” medication since so many people won’t change their BMI category so now we are down to just “managing” higher-weight bodies. It really shows the ridiculousness of this whole weight loss industry constructed facade.

Changes in body composition were consistent with what is expected after weight reduction with various interventions for weight management, including GLP-1–based therapies

It sounds like this is trying to gloss over the fact that in the pooled drug groups, 26.9% of weight that was lost was lean mass. I’ve written before about the issues with GLP-1s and muscle loss previously.

Although the higher discontinuation rate in the placebo group in the current trial was consistent with earlier clinical trials of GLP-1 receptor agonists in patients with ob*sity, the increasing availability of efficacious ob*sity-management medications may have an adverse effect on trial retention. In this trial, 6.2% of patients in the placebo group discontinued treatment because of a lack of efficacy, as compared with up to 1.0% in the orforglipron groups. Other weight-management interventions were initiated by 2.5% of the patients in the placebo group who continued in the trial.

They really need a definition for “efficacious” here, but this speaks to what I was talking about earlier. The people in the placebo group aren’t seeing the weight loss they were promised so they discontinue treatment and move on to a non-placebo option. It also has the potential to impact the study data and analysis.

Trial Limitations

When it comes to trial limitations and strengths, here is what they have to say:

Trial limitations include the lack of comparison with currently approved ob*sity-management medications, the use of cutoffs for BMI inclusion criteria that have been developed in White populations and that exclude patients with lower BMI values who may also have adiposity-related risks, and the increasing availability of ob*sity-management medications, which could have an effect on treatment adherence and efficacy results.

They say a lack of comparison with currently approved medication but they could certainly have mentioned that out of all the existing clinical trials this drug produced the least weight loss (again, I don’t think weight loss is an appropriate target for a healthcare intervention but since these authors obviously do, this little fact seems worth mentioning.)

I appreciate that they mentioned the issues with racism around BMI* but they seem to only be interested in the idea that the current BMI categories might not include enough people. They are also clinging to the idea of “adiposity-related” risks, including the fact that it’s a made-up term for which there is no definition that re-categorizes health issues depending on the size of the person who has the health issues such that even though people across the spectrum have these health issues, the health issues get called “adiposity-related” when higher-weight people have them and/or when it supports weight loss industry marketing programs (this is completely unscientific.) Also, I think it’s pretty interesting to admit that your trial could be negatively impacted because your diet drug doesn’t create as much (short-term) weight loss as other diet drugs.

The strengths of the trial include a highly diverse, large population from nine countries on four continents (Table S12), including more than 35% enrollment of men.

In patients with ob*sity, the use of orforglipron resulted in statistically and clinically significant weight reductions and an adverse-event profile that was consistent with that observed with other GLP-1 receptor agonists.

They mentioned the issues with racism in BMI earlier but they had sites in nine countries on four continents and they still only managed 8.6% of participants who were Black? They are also still underrepresenting men which, by their own admission, likely boosts their weight loss numbers since women have been shown to lose more weight than men on GLP-1s. Once again they are using the terms “statistically and clinically significant” weight reductions without properly defining those terms. This is classic weight loss industry - it’s not just moving the goalpost and declaring victory, it’s creating an imaginary goalpost based on where the ball ended up and declaring victory.

While none of the GLP-1 diet drugs has shown significant sustained weight loss for more than a short time, the injection medications tend to create more short-term weight loss than the pills. Eli Lilly’s Foundayo is meant to compete with Novo Nordisk’s Wegovy pill. The naming is a bit confusing, Eli Lilly’s GLP-1 weight loss injection is called Zepbound but their pill is called Foundayo (and they are different medications), but Novo Nordis’s GLP-1 weight loss injection and pill are both called Wegovy, and they are brand names for the same medication.

Comparison with the Wegovy Pill

So how do they compare? Well, in the Wegovy pill trial (which I wrote about in-depth here) the average weight loss in the drug group was 13.6% over 68 weeks. In the Foundayo trial, there were three different dose groups (6mg, 12mg, 36mg) and the average weight loss in each was 7.3%, 9.3%, and the 36mg group lost an average of 12.4% over a 72 week trial, though the 6mg and 12mg group leveled off at week 36 and the 36mg group leveled off at week 48.

So even at the highest dose Foundayo produced less weight loss than the Wegovy pill. So what’s the marketing ploy? It is the way that they are taken. The Wegovy pill has to be taken under very specific conditions or, as Novo Nordisk’s marketing says “the same way, every day.” Users must get up and take the pill on an empty stomach with a sip of water and then wait 30 minutes before eating. Foundayo has no such requirements so the marketing is around convenience/ease of use.

Foundayo gets special treatment from the US Government

Speaking of other drugs, let’s talk about the approval process for this drug. The drug was approved under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program. The Commissioner in this case is, well was, trump acolyte Martin Makary who resigned in May, about a month after Foundayo was approved.

The CNPV program creates an “ultra-fast” timeline for review of drug applications using a “tumor board-style review process to accelerate review and approval of products that align with one of five critical U.S. national health priorities which include:

Public health crisis response - Products addressing urgent/emerging threats or significant population impact.

If higher-weight people existing qualifies the drug under this claim that would really strain the definition of every word included here.

Innovative breakthrough therapies - Transformative treatments with novel mechanisms that fundamentally change disease management.

Eh, another weight loss drug that produces less weight loss than all the other weight loss drugs? Even with the differences between the Weogvy pill and this pill this isn’t giving “innovative breakthrough” to me.

Large unmet medical needs - Therapies for conditions where existing treatments inadequately address patient outcomes.

Even if someone believes that simply existing in a larger body is a “condition” this “treatment” is the “worst” of the new bunch, but I suppose they could make a (weak) argument about a pill (rather than injection) that doesn’t have specific conditions around when it is taken. Still is this really a “large unmet” need?

Onshoring and supply chain resilience - Onshoring drug development/manufacturing to strengthen U.S. domestic capacity, reduce foreign dependencies, and improve national security.

I have a lot of questions about the idea of “improving national security” through drug production, but in looking it up it looks like this drug is being made in Puerto Rico so it may qualify under this priority?

Affordability - Approaches that improve overall value through reduced costs to the healthcare system or that enhance access to important products.

I’m not sure how this would even be determined. When I looked it up today on Lilly Direct (Yes, Eli Lilly makes the drugs and owns the pharmacy, yikes!) the price for the weight loss dose of Foundayo was $299 while the price for the weight loss dose of Zepbound was $499, but Zepbound creates an average of almost twice as much weight loss so I’m not sure that would count as overall value, even if I thought that weight loss was a healthcare intervention, which I do not.

The FDA bragged in an April 1 press release (content note for weight stigma at the link) that the approval was “Issued 50 days after filing — and 294 days before the application’s PDUFA date of January 20, 2027 — this decision represents a historic milestone as the first new molecular entity (NME) approved under the program. It is also the fastest approval of an NME since 2002.” This makes me think of all the health issues that desperately need affordable treatments (and all the research that is currently being hamstrung by the current US regime), it’s difficult for me to imagine how yet another GLP-1 diet drug, which in early trials had already shown the least weight loss of any of the new class of GLP-1 weight loss drugs, was worth one of these limited vouchers. I have made a FOIA request to find out the names of people who were involved in the approval and I’ll keep you posted.

If you want to learn more about how the weight loss industry is infiltrating and manipulating healthcare, a new episode of Exposing Obesity Incorporated (my podcast with Louise Adams) is out! You can listen to Novo’s Nefarious First Step on Apple or Spotify or wherever you get your podcasts and/or you can check it out on YouTube!

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

I’ve received a ton of reader questions about Eli Lilly’s GLP-1 weight loss pill Foundayo, which was recently granted FDA approval. In Part 1 we’ll talk about the study itself, in Part 2 we’ll break down the discussion, limitations and talk about the special treatment the government gave this drug.

Summary

A group of authors, all of whom are either taking money from Eli Lilly or employees/stockholders of Eli Lilly conducted a trial of a weight loss drug manufactured by Eli Lilly which Eli Lilly not only funded but also designed and oversaw, including with its employees guiding everything from the medical oversight, to statistical analysis, to writing the first draft. The study tested Orforglipron, brand name Foundayo, a daily GLP-1 weight loss pill. The trial tested doses of 6mg, 12mg, and 36mg (after a titration up from 1mg) against a placebo group. All groups were given the same advice around healthy eating and movement. At the end of the 72 week trial, 34.7% of the pooled drug group failed to lose 5% of their body weight, 57.4% of the pooled drug group failed to lose 10%, 76.2% failed to lose 15%, and 88.7% failed to lose 20%. While all groups, including placebo, experienced health benefits, the drug groups experienced relatively small but statistically significantly greater benefits. That said, the authors didn’t actually track behaviors and so it is not clear if the drug or if behaviors created the differences in actual health markers, rather than weight loss.

Deeper Dive

We’ll start, as we always do, with the authors. I’ve summarized the disclosed conflicts of interest (with conflicts with the drug manufacturer highlighted) and for those who appear in the OpenPayments database I’ve included information on the monetary amounts of conflicts from 2019-2025. I will say that I find it interesting that most of the authors who aren’t Eli Lilly employees are taking money from both Novo Nordisk and Eli Lilly, who are rivals in the GLP-1 space. You can find the full study disclosures here.

Sean Wharton, M.D.

Disclosures:
AbbVie, Amgen Canada, AstraZeneca, Bausch and Lomb, Biohaven Pharmaceuticals, Inc., Boehringer Ingelheim, Eli Lilly and Company (Speaking Engagement, Advisory Board), Merck, Novo Nordisk (Scienti c Advisory Board, Academic Speaking Engagement, Academic Advisory Board), Regeneron Pharmaceuticals

Dr. Wharton lives in Canada which does not offer transparency into the amount of pharma patients.

Louis J. Aronne, M.D.

Disclosures: Altimmune, Amgen Inc., AstraZeneca, Boehringer Ingelheim, Clic Bio, Eli Lilly and Company (Consultant and investigator), ERX pharmaceuticals, Intellihealth, Jamieson Wellness, Janssen Biotech, Jazz Pharmaceuticals Inc., Metsera, Novo Nordisk (Consultant / Advisory Board Member, Research Funding), Pfizer, Senda biosciences, Skye bioscience, Syntis, Verdiva Bio, Versanis, Veru Inc, Weill Cornell Medical College, Zealand Pharma A/S

OpenPayments:
General Payments: $316,287.49
Research Payments: $4,144.22
Associated Research Funding: $1,149,211.69
Eli Lilly is his top patron in all categories.

Adam Stefanski, M.D., Ph.D

Disclosures: Eli Lilly and Company (Employee and Stock Holder)
Title: Associate VP-Research & Development-Clinical Research – Cardiometabolic Health
Role: Medical role to provide scientific and clinical support during late phase drug development

Nasreen F. Alfaris, M.D., M.P.H.,6

Disclosures: Eli Lilly (Consultant)

OpenPayments:
General Payments: $10,811.50
(All from Eli Lilly)

Andreea Ciudin, M.D., Ph.D.

Disclosures: Boehringer Ingelheim, Eli Lilly and Company (Grant recipient, consultant), Novo Nordisk (consultant, education)

Dr. Ciudin lives in Spain and so is not included in OpenPayments

Koutaro Yokote, M.D., Ph.D.

Disclosures: Astellas Pharma, Bayer yakuhin, Daiichi Sankyo Company LTD, Eli Lilly Japan (speaking, consulting), KOWA COMPANY, LTD., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma, Novo Nordisk (advisory board, speaking), Pfizer, Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Taisho, Takeda Pharmaceutical Company, Limited

Dr. Yokote lives in Japan and is not included in OpenPayments

Bruno Halpern, M.D., Ph.D.,

Disclosures: Boehringer Ingelheim, Currax Pharmaceuticals LLC, Eli LIlly (Advisory Board), Novo Nordisk (Advisory Board)

Dr. Halpern lives in Brazil and is not included in OpenPayments

Alpana P. Shukla, M.D.

Disclosures: Eli Lilly and Company (Clinical Trial-Site Principal Investigator), Novo Nordisk (Clinical Trial Site Principal Investigator), Sun Pharmaceuticals

OpenPayments

General Payments: $4,883.47
Research Payments: $57,313.20
Associated Research Funding: $1,583,074.76

Eli Lilly is the top patron in every category

Chunmei Zhou, M.S.

Disclosures: Eli Lilly (employee and stock holder)
Title: Director
Role: Project statistician

Lisa Macpherson, M.S.P.H.

Disclosures: Eli Lilly (employee and stock holder)
Title: Director of Statistics
Role: Serve as the statistical lead for this study

Sheryl E. Allen, M.D.,

Disclosures: Eli Lilly (employee and stock holder)
Title: Executive Director
Role: Medical Director for Attain 1

Nadia N. Ahmad, M.D., M.P.H.

Disclosures: Eli Lilly (employee and stock holder)
Title: Associate Vice President
Role: Combined Management and Subject Matter Expert role, leading late phase development programs (Phase 3 trials) for ob*sity medications

Suzanne R. Klise, B.S.

Disclosures: Eli Lilly (employee and stock holder)
Title: Executive Director - Clinical Research Scientist
Role: Serve as medical lead for Phase 3 clinical research

The Basics

As always, quotes from the study will be indented, you can skip them and still get the gist of the piece.

This was a 72 week, double blind placebo controlled trial of Orforglipron, brand name Foundayo, a GLP-1 weight loss pill created by Eli Lilly. The trial was funded by Eli Lilly, but they did way more than fund it:

The trial sponsor, Eli Lilly, designed the trial and oversaw its conduct. Trial investigators were responsible for data collection. The sponsor performed site monitoring, data collation, and data analysis. The investigators and authors worked under confidentiality agreements with the sponsor. The authors, with assistance from sponsor-funded medical writers, wrote the first draft of the manuscript. All the authors had access to the data and analyses, interpreted the data, critically reviewed the manuscript, approved the decision to submit it for publication, and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.

Participants
The study include people 18 and older with a

“BMI of at least 30 or who have a BMI between 27 and 30 and who have at least one ob*sity-related complication, including hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea, and a history of at least one patient-reported unsuccessful dietary effort to lose body weight.”

You’ll notice that “ob*sity-related complications” are health conditions that people of all sizes get that get called “ob*sity-related” when higher-weight people have them. They are also continuing to use the BMI threshold of 27. This is curious because BMI is a deeply problematic and unhelpful metric and, in fact, the only thing it has going for it is precision - per BMI, the “overw*ight” category starts at a BMI of 25, yet these GLP-1 trials consistently start at 27, suggesting to me that they looked at the data from their Type 2 Diabetes trials and cherry-picked this BMI range to get the largest effect during the trial period.

The mean age of the patients was 45 years; 64.2% were women; and 56.5% were white, 28.6% were Asian, and 8.6% were Black, 37.6% were Hispanic or Latino. At randomization, the mean body weight was 103.2 kg and the mean BMI was 37.0. A total of 46.0% of the patients had a BMI of less than 35, and 36.0% of the patients had “prediabetes”.

Procedures

The patients were randomly assigned to Orforglipron doses of 6mg, 12mg, 36mg, or placebo. They were assigned 3:3:3:4.

I’m going to interrupt the study analysis to clear up some misunderstandings I’ve seen floating around. I’ve seen well-meaning people saying things like “the 6mg minimum dose of Foundayo is 12 times higher than the 0.5mg minimum dose of semaglutide!” I understand why people are confused but, also, that’s not how it works. The dosages between drugs are not comparable. In fact, the dosages between injection and pill are also not comparable, even if the medication is the same. While we’re on the subject, the medication in Novo Nordisk Wegovy pill is semaglutide, the same medication that is in the Wegovy injection, but the medication in Eli Lilly’s Foundayo pill (Orforglipron) is NOT the same medication as in Eli Lilly’s injectable Zepbound (tirzepatide). Moving on…

Orforglipron is a capsule that is taken daily. As is the case with all GLP-1s, whether used for actual health benefits or weight loss, there was a titration up from a low dose. Subjects were started at 1mg dose and then titrated up each week until they got to the dose their group was assigned (6 mg at 8 weeks, 12 mg at 12 weeks, and 36 mg at 20 weeks.) The goal of the low starting dose (often called the subtherapeutic dose) is to get the body used to the medication and hopefully reduce side effects as the dose is titrated up. Because this is a weight loss dose, the medication is relentlessly uptitrated to the assigned dose (unlike GLP-1s for Type 2 Diabetes where the goal is to give the minimum dose to reach desired glycemic management and minimize side effects.) Since weight loss is simply a side effect of these drugs, the goal of dosing/titration is to maximize the side effect of weight loss.

Each participant also received “individualized lifestyle counseling focused on a healthy, balanced diet combined with physical activity.” This is good news in that they did not recommend caloric restriction (like other trials have,) however there was no mechanism to track whether/how participants practiced this advice and thus no way to determine if behavior changes, and not the drugs, or weight loss were responsible for health benefits.

The primary end point was “percent change in body weight from baseline to week 72” and “Multiplicity-adjusted secondary end points were the percentage of patients who had a reduction in body weight of at least 5%, 10%, 15%, or 20% at week 72, along with the change from baseline to week 72 in waist circumference, systolic blood pressure, non–high-density-lipoprotein (HDL) cholesterol, and triglycerides. Additional secondary end points included changes in glycemic measures, diastolic blood pressure, and other lipid measures. Changes in body composition from baseline to week 72 were assessed for a subgroup of patients by means of dual-energy x-ray absorptiometry (DXA)”

They determined that “a sample size of 3042 patients would provide the trial with at least 90% power to show the superiority of individual doses of Orforglipron over placebo for the primary end point.” The study started with 3127 people. Administration of Orforglipron or placebo was continued throughout the 72-week trial period in 75% of the participants (2344 patients). The dropout rate in the drug groups increased slightly with dose with 21.9% of the 6mg group failing to stay on the drug for the full 72 week trial, 22.5% of the 12mg group failing to stay on the drug for the 72 week trial, and 24.4% of the 36-mg group failing to stay on the drug for the full trial. In the placebo group, 29.9% failed to stay on the placebo for the full trial.

This deserves some unpacking because these are fairly high dropout rates in both the drug and placebo groups, but not necessarily for the same reason. It’s important to remember that people who joined these trials wanted to join a weight loss trial. In the placebo group, withdrawal can be because they don’t experience any of the expected side effects or any weight loss and so they realize they are part of the placebo group and they drop out of the study. In the weight loss groups, you would expect more motivation to stay in the group, but they are also experiencing side effects. In this case, 13.8% of the placebo group withdrew due to “patient’s decision” while 8.5-8.9% of the drug group listed this reason. 5.1%-10.3% of the drug group withdrew due to “adverse events” (with higher numbers at higher doses) while only 2.6% of the placebo group did.

Weight-related findings

Average weight loss was:
6mg: 7.5%
12mg: 8.4%
36mg: 11.2%

If we dig a bit deeper:

Failed to lose 5%
6mg: 39.4%
12mg: 36.5%
36mg: 28.2%

Failed to lose 10%
6mg: 66.7%
12mg: 60%
36mg: 45.4%

Failed to lose 15%
6mg: 84.9%
12mg: 79.7%
36mg: 64%

Failed to lose 20%
6mg: 93.6%
12mg: 91%
36mg: 81.6%

Additional Treatment Outcomes

Here they report that the drug “significantly improved cardiometabolic risk factors” including “systolic blood pressure, non-HDL cholesterol, and triglycerides.”

To measure these, they pooled all of the dose groups together which is… a choice that we’ll discuss more in part 2. For now, they reported that the difference in systolic blood pressure was a pooled average of -5.7mmHg (−5.0 to -6.3), while the placebo group averaged −1.4 (-.05 to −2.4). The difference in non-HDL cholesterol in the pooled drug groups was −6.7 (-5.8 to −7.6), while the placebo group averaged −1.9 (−0.2 to -3.6). The difference in triglycerides in the pooled drug group was −14.8 (-13.3 to -16.3) while the placebo group averaged −3.8.

They also point out that Orforglipron was associated with improvements in diastolic blood pressure, other lipid fractions, high-sensitivity C-reactive protein… as well as levels of glycated hemoglobin, fasting glucose, and fasting insulin”

The fasting glucose changes aren’t a big shocker - remember these aren’t really weight loss medications, they are type 2 diabetes medications with a side effect of weight loss. This also begs the question - if this group of people were given a different Type 2 Diabetes medication, would they have seen similar improvements?

Regardless, both the drug and placebo groups showed improvement in all areas with relatively small, but statistically significant, differences between the pooled drug group and the placebo group, though there was some overlap between the individual drug groups and the placebo groups. As a reminder, statistical significance is not a measure of the size or importance of the difference, it just means that, statistically, it’s more likely that the difference was due to the medication than due to chance (more about statistical significance here). Except there is a big confounder here - behaviors.

I have often said that there should be weight-neutral comparator groups in these trials. Now, this wasn’t actually weight-neutral since it was counseling that was done under the guise of a weight-loss trial, but at least they didn’t recommend caloric restriction. Again, an issue with the trial is that both the drug and placebo groups are given advice about food and movement (to be clear, there are many other aspects of health but it seems that food and movement are always the myopic focus of this kind of “counseling”.) Since both groups are given the same advice about food and movement, we are meant to believe that this will control for whether or not the drug/drug-induced weight loss is actually creating any health benefits. But as my stats professor used to say “if you didn’t track it, you can’t claim it” and this is definitely the kind of thing she was talking about.

For that control mechanism to work, we would have to know if the actual behaviors were the same in each group. Let’s look at one of many possible examples. If the placebo group realized that they were on the placebo, then they may have been less motivated to exercise may have made different food choices than the people on the drug, who may have felt more motivated to exercise. If that’s the case, increased movement and different food choices in the drug group could be responsible for all the differences in actual health benefits we see here. Of course we have no idea if that happened. It’s not enough to give food and movement “counseling,” these trials should actually track the behavior they are “counseling” people about, especially since there is a body of research that finds that behaviors can have significant impacts on health.

So that’s the study, in Part 2 we’ll break down the authors’ interpretations of the results and look at the very special treatment the government gave this drug very special treatment.

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

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I recently heard from Samantha C who was suffering from what she described as “absolutely crippling plantar fasciitis.” Over three years of treatment, a mistake by her treating provider caused the situation to degrade from being able to walk, to the point where any amount of walking created pain within one or two minutes. She had a surgeon who was prepared to move ahead, but the facility he worked at had its own BMI limit, which she was over by approximately 100 pounds. As she pointed out “Obviously, losing 100 pounds for this surgery is not viable as an option even if I did have two working feet, which I don’t... “

Here I want to point out that BMI-based denials of care, in which healthcare is held hostage for a weight loss ransom (which shouldn’t happen at all), can happen at many points and come from many sources including the surgeon, anesthesiologist, facility, and/or insurance. Instead of asking higher-weight patients to stop existing, healthcare should get better at providing care to higher-weight people. In the meantime, if you are dealing with this kind of denial (or if you think you might) I previously posted a step-by-step guide, including research collections specific to joint surgery, gender affirming care, and lumbar spine surgeries.

At that point her only option was to find another doctor and that’s where she ran into yet another barrier:

“Now I’m trying to find yet another doctor and I don’t know how to screen for or research surgeons who work in facilities without this BMI limit. My primary care doctor was no help at all. I’ve tried looking at hospital websites but the lists of doctors are overwhelming, and of course no one has email addresses, only phone numbers. I don’t have time to call all these people during their office hours... Do I start with the doctors? The hospitals? Finding a patient advocate? Something else?”

When people give advice to higher-weight people whose healthcare is being held hostage for a weight loss ransom that they should “find another doctor,” we also have to be aware and clear how difficult that might be. And, in the case of those who are locked into HMOs and other restrictive insurance plans, it can be impossible.

Samantha continued:

“I will say, I was SHOCKED by how hard it was to find information as a patient without a doctor chosen yet. I just kind of assumed I could call a hospital, find out if they had a BMI limit for surgery, and then ask for a list of doctors who worked at that hospital.”

This is a completely reasonable assumption to make. If hospitals are refusing care based on body size, the least they could do is make that information easy to find. Alternately if they truly make decisions on a case-by-case basis and have no hard BMI limit (and are not just saying that because they think they might be in legal trouble for telling the truth,) then they should communicate that too. The lack of transparency into healthcare is a serious issue for many people in many ways, but for those fighting weight stigma to get care, it can be much worse and, of course, that is compounded for those who are at the highest weights and/or have other marginalized identities and are dealing with things like racism, ableism, homophobia, transphobia, ageism and more on top of weight stigma.

Samantha shares the frustrating process:

“First of all, I didn’t seem to have any way to contact the individual departments within a hospital. I could only get to a scheduling line staffed by people who make appointments at hospitals all over the area. They couldn’t give me any information about any specific hospital, and couldn’t look up which doctors worked where.”

This is, unfortunately, incredibly common. A similar issue happens for higher-weight people who are trying to access imaging equipment. Finding out if the actual equipment in a facility is able to accommodate them can be a herculean task. Here I recommend the In Our Image Project from the Fat Legal Advocacy, Rights, and Education project. This is a project that I worked on as their Legal Fellow. It is a database meant to help higher-weight people find accessible imaging options. I also have a guide for imaging techs working with higher-weight people here.

Back to Samantha’s experience:

“So I ended up just kind of googling podiatry practices in the general area. I did get a list from my insurance company of practices in their network (although it didn’t distinguish between places that did and didn’t take my specific form). I called the practice and explained, ‘I had a plantar fasciitis surgery scheduled, but my doctor canceled because his facility had a BMI limit. Before I make appointments and drive in and waste everyone’s time, I want to make sure that doesn’t happen again months down the line.’

“A lot of people were helpful but multiple places told me that they couldn’t give me that kind of information until I came in for an in-person consultation. No, they don’t do telehealth, no I can’t talk to the surgical coordinator first. We can’t give you any medical advice without seeing you first. I tried to explain I’m not asking for medical advice, I’m asking for objective information about your practice? I had someone tell me, ‘We’re not going to go around like this’ and shut me down like I was asking for something entirely unreasonable.

“It felt like I was asking ‘Does your office have a wheelchair ramp?’ and the answer I kept getting back was ‘We can’t know if you need a wheelchair or not without having you come in first.’”

I have absolutely run into this before while advocating for patients and it can be infuriating. The idea that everyone has the time and money (and all the other resources including time off work, childcare, transportation etc.) to make and attend an unlimited number of doctors appointments with every doctor in (and sometimes out of) town to see if there is a doctor willing to provide care for them is ridiculous, unrealistic and classist. (I’ve also had providers’ offices say “we decide these things on a case-by-case basis” and after they assured me that the patient would be considered for surgery, and after the patient made and attended the appointment - and they/their insurance paid for it - they were told by the provider that the provider had a BMI limit with no exceptions.)

Healthcare providers/offices/facilities should be honest and transparent: “We have chosen not to provide healthcare to people with a certain height/weight ratio” is not medical advice. “Our equipment fails to accommodate people of a certain weight/size” is not medical advice. And whether it’s a wheelchair ramp or other disability accommodation, an inclusive surgery/procedure policy, or accommodating equipment, this information should be available for patients without requiring them to make, attend, and pay for an appointment just to find out that the healthcare provider/office/facility fails to accommodate them.

During our original email exchange, Samantha’s story had taken a positive turn:

“Through the brute force method of calling every podiatric surgeon in my network, I found a surgeon willing to work with me. I still have to wait for the clearance from the hospital anesthetic team, but if I get a no there I know how to put more of your and others’ tactics to use to ask for someone who knows how to handle a fat patient. Wish me luck!”

Yesterday I heard that she got the outcome she deserved:

”I'm in the clear! The hospital team is more than happy to have stuff in place to intubate me and make sure I'm safe in anesthesia. I'll be having my surgery on the 10th.”

I’m overjoyed for Samantha. Still, and as always, I want to be clear that even if you are able to do everything Samantha did (and many people are NOT able to do that for any number of reasons, all of which are valid,) there is still no guarantee that your situation will end with you successfully accessing healthcare. As with all weight stigma, this is NOT your fault, even though it becomes your problem. And like with all weight stigma, those of the highest weights and those with multiple marginalized identities (in particular higher-weight Black and brown folks since weight stigma is rooted in and inextricable from racism and anti-Blackness*) are the most harmed when healthcare is held hostage for a weight loss ransom and a lack of transparency makes it borderline impossible to even understand your options.

Even if, tragically, you are not able to receive the excellent weight-inclusive care you deserve, that doesn’t change the fact that you do, and always will, deserve it!

Massive thanks to Samantha for sharing her story and don’t forget that if you know of a weight-neutral doctor, you can add them to this master list that Mary Lambert pulled together from lists that various members of the community had created!

This month’s online workshop is Truth, Lies, and Measuring Tape - Reading Between the Lines of Weight Loss Research. I’ll will teach you the basics of breaking down research and analyzing media article and social media to break through the BS and get to the truth of what the research finds (and what it doesn’t) and what that means for how the research can (and can’t) be applied to real life. This workshop is for everyone - from research newbies, to research nerds! There is a pay-what-you-can option so money isn’t a barrier and all registrants get a video. Details and Registration here!

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

Welcome to another installment of the 5 Questions With… series.

If you’re a new reader (hello and welcome!) this is a series where we learn a bit about experts in the field. Previous interviewees include Mikey Mercedes, Aaron Flores, Dr. Gregory Dodell, Lisa Du Breuil, Dr. Asher Larmie, members of Medical Students for Size Inclusivity, Chrissy King, Jessica Jones, Leslie Jordan Garcia, Dr. Mara Gordon, Dr. Whitney Trotter, Dr. Anna Whelan, Angela Goens, Dr. Maayan Simckes, Dr. Lesleigh Owen, Dra. Mónica Peralta, and Dana Sturtevant, Hilary Kinavey, and Sirius Bonner, and Angel Austin.

Today we are joined by Dr. Jennifer Gaudiani (aka Dr. G)! I am so excited for you to read her interview and experience a medical doctor who is working from a truly fat positive perspective!

Without further ado…

1. Tell us a bit about yourself and your work.

I am an internal medicine physician who has specialized in eating disorders for the past 18 years. I came to this work starting by being the oldest of 3 sisters, and when I was in medical school, my sister developed an eating disorder and has been super gracious about allowing me to name her as my inspiration to get into the field.

I supported her as a sister because I didn’t know anything about eating disorders and was incredibly grateful to watch her recover over many years. But I think it very much opened my heart to understanding how complex eating disorders are, and how wildly important a recovery process is.

So when I completed my training as an internal medicine doctor, I moved to Denver in 2007 with my husband and then toddler daughter, and I started working at Denver Health, which is the inner city teaching hospital for the University of Colorado. I was an inpatient internist, and I got an email about a year into my employment by the head physician for the hospital, who, unknown to me, was the, world expert in the medical complications of eating disorders. And he said, who wants to help me grow and run the nation’s top medical inpatient program for adults whose anorexia nervosa has become so medically complicated they can’t receive care anywhere else?

I instantly volunteered, and I fell in love with this patient population and their families, and the medicine. I was an English major in college alongside my pre-med requirements, and my my focus was close reading poetry. So the essential science of things often is out of my grasp. I failed organic chemistry the first time I took it. And along the same lines, listening to words and trying to communicate to the heart, encouraging people to tell their stories and listening carefully to the words they use and the words they don’t really resonated with me. And it turned out that being a listener and wanting to understand people’s narratives were key to doing this work the way I think it needs to be done as a doctor.

I adored it. And I became an educator as well in the process of things. And after 8 good years there, I left and I founded my own outpatient clinic called the Gaudiani Clinic. It’s based in Denver, but my 3 wonderful physician partners and I are together licensed in around 45 states and see folks of all ages, genders, body shapes, and sizes, helping with the medical things that happen either directly due to an eating disorder or alongside an eating disorder in ways that may derail recovery.

And we are passionately determined to remove barriers medically, sometimes psychiatrically, and medically, from people’s recovery journeys. And we are passionate, not only weight-inclusive but fat-positive providers.

2. How did you learn about the concept of weight-inclusive, body-affirming care?

When I founded the clinic, I had enough experience in the eating disorder world that I knew about my own internalized biases. I understood some of the sociological and structural inequities that contributed to harm for people in diverse body sizes. And I knew that I wanted to be caring for people in absolutely all body sizes in the clinic. But I have to admit that I didn’t exactly know how to put that into play. And I made plenty of mistakes in the early stages of the clinic, but I was so grateful for a number of wonderful teachers, including you, who were generous enough to see the intention was there and to help inform me about what I needed to know.

I think the, the first time that I really, really started to get it as a person who lives with thin privilege was when I went to a Binge Eating Disorder Association conference, and I listened to some extraordinary humans really laying out for me the foundations of social justice and constructs of white supremacy and sizeism that made me suddenly go, Oh!. And after that, it was a matter of applying those constructs to the way that I was providing medical care.

And it was a process that I loved learning into. And felt very comfortable being humble through, because I’ve done enough work that I’m not at all interested in asserting some sort of expertise by always being right. I’m much, much more interested in showing a long history of being in the field by acknowledging when I don’t know what I’m doing and seeking out ways of doing things better or in a more correct fashion.

This was one of the core competencies that I really had to learn, certainly before I could practice it and then before I could teach it.

3. How have you/do you apply those concepts to your work?

So this is my favorite part because I just love patient care and we try to think about being weight inclusive. And I’;m going to use that term interchangeably with fat positive, but I prefer the term fat positive in my medical work across the board.

That might start with online, on our website, in our social media, we are never posting anything that could remotely be construed as diet-focused or thin-oriented. We try to create content that is representative and that shows our values. In the physical space of our office, we very deliberately chose furniture from the exam tables to every seat in the office that was comfortable for all bodies, including disabled bodies. And we chose to make sure that the hospital gowns when we were doing exams or the blood pressure cuffs were always set up ready and welcoming to all bodies who walked in, not sort of that awkward fumble of, oh, oh, oh, we’ve gotta remove this cuff and change it, you know. We want people who walk in to feel immediately loved and accepted and warmly welcomed.

Then it comes down to the way that we practice medicine, in which unless I am monitoring a patient of any body size for specific weight restoration, I’m not going to check a body weight because it is not a vital sign that is vital. It does not tell us things about people’s health. To understand people’s health, you have to ask them about the lived experience of being in their body. And you will also get some benefits from certain measurables like blood work perhaps, or vital signs, but it is both. And we are just absolutely focused on helping patients know from the get-go that we are never going to seek weight loss as a therapeutic strategy.

I very early on became enamored of Health at Every Size and have continued to follow its fundamental pillars over the years, and also continued to construe those in a Western medical setting, where, for instance, I don’t disallow conversation about body distress. I’m not a therapist, but I’m always happy to hold space to hear about how someone is being harmed by the systems they are in as a result of their body or their medical diagnoses. But we never respond to those by saying, great, let’s change your body. And I also have taken an approach that perhaps in some way moves a little bit from some of the wonderful, vital trailblazers who have made this field what it is and who have, by the way, made weight-inclusive care the standard of care across any reasonable eating disorder care in this country.

If people aren’t weight inclusive as eating disorder providers, to me, they are stuck back in cave person times.

But, you know, one of the things that I want to say here is that I’m able to acknowledge that there are certain medical problems that can occur in part associated with higher weight. And all of the other things that go into this, including trauma and including food adequacy from childhood and including medications and family of origin and stigma and discrimination and all other modes of otherization. But because as a Western internist, I do understand that there are certain causes and effects, I think it is more powerful that I will never, ever, ever recommend weight loss therapeutically.

Instead, I will bring to bear my medical knowledge about how I might treat diabetes or hypertension or hyperlipidemia, and I use medications for those. And we use ways of perhaps moving one’s body within interest and desire but never focus on weight loss. And so in so doing, I think we have created a safe space for people to be in their bodies, to recover from their eating disorders, and to know that they’re going to be held and not harmed.

We also try to think about being trauma-informed, and we think about how do— what does it mean to be a trauma-informed physician? And for instance, when we do a physical exam, we are nerdy to the extreme about saying, we believe so much in your body’s autonomy, not necessarily knowing what you’ve been through in your body before, that anytime I approach your body with my stethoscope, I’m gonna ask you permission to listen to and examine that specific body part. I’m not just gonna move into your space and assume I can do these things to you, which is the standard of, of care in medicine.

Sometimes patients laugh at us when I’m like, May I please listen to your heart? Thank you very much. Here’s what I heard. May I please listen to your lungs?” And sometimes I’ll say, “Just say no. Just say no. Enjoy the act of saying no to a physician and having the reparative experience of them being like You got it. You’re the boss.” But we try to think about that as well, and I think it’s a key part of what we do.

4. What’s one thing that you wish people who are still working from a weight-focused paradigm could learn or know?

This maybe sounds too simplistic, but the sentence that comes to mind is stop telling people to lose weight. Period. We’re in a really complex time right now for so many reasons. And the truth is, is that one can provide absolutely wonderful outpatient medical care and never encourage someone to lose weight In fact, it’s the only way to provide truly good outpatient medical care.

So if I could wave a magic wand with regards to this topic for medical providers around the US, I think that’s what I’d use it on. .

5. How and where do we find you and your work?

Gaudiani Clinic.com We are located in Denver, Colorado, but do exclusively telemedicine work, including primary care work with people in larger bodies who are sick of being harmed by the medical system. And, you know, somebody may have a remote history of an eating disorder, but If someone calls us and says, I would just like good primary care or management of my mast cell activation syndrome, management of my POTS, I am a person in a larger body and I would just really love not to be stigmatized. We love caring for folks like that.

My book is called Sick Enough: A Guide to the Medical Complications of Eating Disorders and Undernutrition.

And the second edition came out in November. And I got to read the audiobook this time, which came out in February of 2026. So I encourage people to acquire that wherever they buy books or download audiobooks. And I feel really proud of the second edition, which I worked for a super long time on and corrects errors in the first, adds a ton of new material, and people can just pick and choose what&#39;s relevant to them.

I also think that I recognize the privilege of my credentials and my medical training. It gives me a certain platform, unfairly, that I really am keen to use for good. So when people don’t necessarily have access to seeing the doctors in our clinic specifically, potentially they can buy the $20 book and read through what’s relevant, which is all cited with updated medical literature, and bring it to what I would like to hope is their curious and welcoming nurse practitioner or physician assistant in primary care. I’d like to include MD in that, but the truth is, is that I, I love being an MD, but we can be pretty tricky as a profession and not always super responsive and receptive to new things, but some are. So if you got one of those, awesome.

Bringing the book to your provider and saying, would you be willing to read this chapter? Would you be willing to see how this physician who is Harvard, Boston University, and Yale educated thinks about this stuff so that they can sort of put on the cape of my educational privilege in order to help improve systems from within. They shouldn’t have to. They shouldn’t have to do that work, but it’s an option if that’s right for them.

We are @GaudianiClinic on the socials as well:

Instagram - https://www.instagram.com/gaudianiclinic/

Facebook - https://www.facebook.com/gaudianiclinic

Bonus - Anything else you’d like to say?

Oh, one of my favorite questions that was not asked as I was growing up, but that I learned from my patients to ask my daughters as I raised them with my husband was, what do you need right now?

And it’s a really complex question for so many reasons. But I think in the eating disorder world, it’s not uncommon for people to have a hard time asking themselves the question, what do I need right now? Being compassionate with themselves for having a need and then allowing themselves to meet that need. And so I think I offer a warm encouragement recognizing there’s plenty of barriers to answering this question for many, both in the world and within the soul, to think as often as possible, what do I need right now? And respond to that with kindness and be as responsive as possible.

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

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One of the most common questions I get when giving talks to providers, and not just talks that are explicitly focused on the research around GLP-1s but literally any talk about weight-inclusive healthcare, is about informed consent. After all, these drugs are FDA approved here in the states for weight loss. Driven by
a 10-year, 3-step plan created and publicized by Novo Nordisk to “build the ob*sity care market from scratch” to maximize their GLP-1 weight loss drug profits (which Louise Adams and I will discuss in-depth on our podcast), we have seen a combination of factors including (but certainly not limited to):

• Astroturf “patient-advocacy” groups working hard to influence not just patient and provider behavior, but also public health messaging, government and policy

• Extremely sketchy research creating misleading messages everything from body size itself, to the realities of the drugs, to how much weight is regained when people go off the drugs and much, much more

• Education created by the weight loss industry delivered directly to healthcare providers

It’s no wonder that there is so much confusion about informed consent for these drugs. As I have said many times, I believe in bodily autonomy and people have the right to attempt weight loss for whatever their reasons or beliefs (and we absolutely can’t discount the ways that a world that is rife with weight stigma and a healthcare system that holds healthcare hostage for a weight loss ransom create a coercive environment.) I also take a firm view about the ethical, evidence-based practice of medicine and this is where I think that informed consent is failing patients.

Today I’m excited to let you know about two resources to help guide the informed consent process around GLP-1s.

The first is the updated GLP-1 Informed Consent from Medical Students for Size Inclusivity. This is an incredible group who, in addition to this resource, do a ton of important work for weight-inclusive health. In their words: “Advocacy with among current and future healthcare providers, community outreach and education, student-led research, and medical school curricular reform.”

You can find the updated GLP-1 Informed Consent from Medical Students for Size Inclusivity here.

The second resource is from the Center for Body Trust, who do absolutely incredible to, in their words “examine the toxic structure in which our construct of health lies, and discover what is possible when people are trusted with their bodies.”

They have created a set of ethical guidelines that are built on and informed by the MSSI GLP-1 Informed Consent, digging deeper into the greater ethical issues around the use of these drugs for weight loss.

You can find the Center for Body Trust Guidelines here!

Full disclosure, both of these tools cite my work, I am on the Advisory Board for MSSI and offered comments on drafts for both the new and revised document. That work was not compensated and I’m not compensated if people go to the links or use the work in any way.

Informed consent is the cornerstone of healthcare practice and far too many providers either don’t have the information they need, or are being actively misinformed by advertising and “education” that seems to me to consistently put profit before people. This has left a wide gap between the realities of these drugs, and the information that patients often have access to from healthcare providers. MSSI and The Center for Body Trust have done an incredible of filling that gap!

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

In part 1 we talked about the platform (Epic Research), the researchers, and the basic methodology for reporting. Today we’re going to get into the analysis. Remember that there are two sources, the first is the actual article, the second is what I am calling the supplementary materials that is a pdf that is linked (though not at all clearly) in the article.

We’ll compare the claims made in the article to the data shown in the supplementary materials. I think as we get into this it may be helpful (and maybe just a bit comforting) to remember that this was not published in a peer reviewed journal - it’s Epic publishing Epic’s research on Epic’s website.

We’ll begin with the most basic claim: “we studied 188,722 patients who stopped using a GLP-1 medication after being on it for at least 90 days and who lost at least 5 pounds while on it.”

You might be thinking “wait - in Part 1 you said the study population was 323,782, what happened to the other 135,060 people? Let’s go on this journey together. We’ll start by looking at their data. In the supplementary materials, Table 1: Characteristics of the Study Population looks like this:

So they say in the article that they studied 188,722 patients but the very first line of the supplementary materials chart about the study population says that the total number of patients was 323,782. But it gets a bit weirder, if you add up all the participants in the different age categories you get 323,750, 32 short. If you add up the totals across the drug groups you do get 188,722, if you add up the participants in the weight loss category you get 323,782. If you add up the diabetic status you get 323,782. What is going on here? Maybe they originally looked at 323,782 records of which only 188,722 were not excluded for some reason, and maybe 32 of the participants did not have an age on their electronic health record? At least the number of people across the drug groups in the supplementary materials chart matches the number of people they claim to have studied but this is, in the absolute more charitable description, an extremely confusing way to present this data.

In part 1 we discussed the fact that the inclusion criteria were not particularly stringent but the biggest issue, to me, is that the researchers appear to have just done calculations with whatever data they happened to have, but reported it and drew conclusions as if they had consistent data on all participants.

For each of the three drug groups (semaglutide, liraglutide, tirzepatide), they present an interactive graph that shows “the proportion of patients by amount of weight regained or lost after stopping [liraglutide/semaglutide/tirzepatide].”

Let’s dig in.

In the article we find Figure 1 - Proportion of Patients by Weight Change After Stopping Semaglutide we can see in the lower left “n=139,972 patients.”

But if you look at the supplementary materials you find Table 2 Proportion of Patients by Weight Change After Stopping Semaglutide. This is the table from which they are drawing the data for Figure 1.

The final column of the supplemental table is “patients” and the number in that column represents the number of the original 139,972 patients who had taken (and subsequently stopped taking) semaglutide for which the researchers had a weight at each month of their calculation. At month 1, the researchers had a weight for 68,754 of the patients and this number trends steadily downward until month 24 when they only had weights for 2,650 of the original 139,972 patients. At literally no point does Figure 1 in the original article give data for the n=139,972 patients the label claims.

In the liraglutide group the graph in the article says n = 23,377. The supplementary tables show that in month 1 they had weights for 11,580. That steadily declined until month 24 they had weights for 1,268 of the population.

In the tirzepatide group, the article says n= 25,373 patients. At month 1 they had weights for 12,909 patients which steadily declined until at at month 24 they only had a weight for 145 people (that is not a typo, they were doing the two year calculation upon which they drew their bold conclusions with only one hundred and forty five of the original 25k+ people represented!)

This is such a bonkers way to do this that I actually emailed them, using the semaglutide table as an example, to make sure I was understanding this correctly. They assured me that I was:

“Yes – there were 139,972 total patients on semaglutide who met the conditions in the study cohort. The patient count in Table 2 represents the number of patients that had a weight reading in a given month, so patients can be represented in multiple months.”

So let’s discuss the “key findings”

At 24 months post-cessation, 56% of semaglutide, 52% of liraglutide, and 55% of tirzepatide patients kept the weight off or lost additional weight.

Complete weight regain occurred in 23% of semaglutide, 21% of tirzepatide, and 27% of liraglutide users at 24 months.

Weight trajectories stabilized after 12 months, with only small variations in the distribution of weight outcomes through year two.

Remember that when they state these 24 month findings (or when in the title they say “Most Patients Sustain at Least Some Weight Loss,”) these statistics are drawn from information for only 1.9% of the semaglutide group, 5.4% of the liraglutide group, and 0.57% of the tirzepatide group. When they say kept the weight off or lost additional weight, subjects would qualify if they maintained 1% of the weight they lost.

EDIT - I’m adding this paragraph for additional clarification based on a great comment below. If you look at their percentages, it can seem like a lot of people didn’t regain weight. For example in the Semaglutide group, for example, at 1 month the “doubled their weight loss group” was 5.01% of 68,754 participants. That’s that’s about 892 people which is 0.64% of the original 139,972 people. At 24 months it was 25.89% of 2,650 people. That’s about 686 people which is about 0.49% of the original 139,972 people. As I mentioned in part 1, we also don’t know if this miniscule percentage of the total group even actually stopped taking the drugs, or if they started getting them from a different source that did not add them to their medical chart.

What happened to the 98.1% of the semaglutide group, 94.6% of the liraglutide group, and the staggering 99.43% of the tirzepatide group for whom the researchers did NOT have a weight at 24 months? Is it more likely that people who were regaining weight did not come back to get weighed in? These researchers have absolutely no idea and they don’t seem to care.

(They said that weight trajectories stabilized at 12 months so even if we look at the data at 12 months they only had weights for 12.7% of the semaglutide group, 18.5% of the liraglutide group, and 8.1% of the tirzepatide group.)

Under limitations they state “We allow a patient to be included in each month, using their highest weight in that month. Patients who have repeated weight measurements might be the extremes of weight change.”

Gentle readers, I would say that this is the least of their limitations. The fact that they are stating these incredibly broad conclusions about weight regain (including in the title!) based on a tiny fraction of the data they’ve led us to believe is included, and that they AT NO POINT disclose any of that in the main paper is, to me, unforgivable.

Horrifyingly, in researching this piece I found other studies that actually cited this one so I’ll end this by saying that this study completely lacks the academic rigor or appropriate methodology necessary to be used to counter research showing high rates of weight regain after GLP-1 cessation. GLP-1s are being taken by a huge percentage of people and being prescribed (and in some cases pushed) by many prescribers, research like this has the potential to do incredible harm by generating blatant misinformation. We have to do a whole lot better than this.

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

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Every month, paid subscribers can participate in an Ask Me Anything and the study I’m writing about today was brought to my attention during the June AMA. It is, if not the worst, one of the top 3 worst studies I have ever analyzed so strap in because we are going for an EPIC ride.

The study is called “Two Years After Stopping GLP-1s, Most Patients Sustain at Least Some Weight Loss” and it was published on Epic’s website on September 9, 2025.

The study is an Epic Cosmos Study by Epic Research. Epic is best known for their Electronic Health Records and they describe themselves as a company that “develops software to help people get well, help people stay well, and help future generations be healthier.” Epic Research describes themselves as “Epic Research (Epic Health Research Network, Inc.) is a public benefit corporation, to benefit the healthcare community and, ultimately, the general public.” Cosmos is a project of Epic, it is “a dataset created in collaboration with a community of health systems using Epic and is designed to improve patient care. By combining their data, participating organizations and Epic can make new discoveries and advance medicine. Cosmos also powers tools at the point of care, providing insights to clinicians that are tailored to the patient in front of them.”

This study was created by not one but two research “teams.” Epic explains the process on their website thusly:

An idea is presented for evaluation.

We assign two independent teams to explore the topic. Each team is comprised of a clinician and a data scientist.

The two teams are provided with the same question to answer but not with a required study design. From there, they explore the data that they independently determine to be relevant to the initial prompt.

Once each team has completed its investigation, they come together and present their findings.

They compare results and methods and finalize the key takeaways from their analyses. The teams then write a single study brief summarizing their finalized methods, findings, and any actions that may be supported by the study data.

Once the teams have completed writing their Epic Research brief, they submit it for review by a panel of additional experts. This panel includes clinicians, subject matter experts, and other relevant reviewers based on the topic.

Once this review is complete, the Brief is published on Epic Research and shared with our subscriber network.

I’m going to take them at their word but I have to be honest that the idea that two independent teams came up with this same cockamamie methodology is very difficult for me to believe.

Researchers

So let’s look at the teams.

Team 1 is Kersten Bartelt, RN and Joe Deckert, PhD.

Kersten Bartelt: According to her LinkedIn, Bartelt is a full-time employee at Epic as a Research Clinician.

Joe Deckert: According to his LinkedIn, he is also a full-time Epic employee as a Data Science Manager. He writes “I’m a data scientist at Epic, working with data from Cosmos and publishing my work on EpicResearch.org.”

Team 2 is Blaine Franklin, PT, DPT and Eric Barkley

Blaine Franklin: According to his LinkedIn he is a full-time employee at Epic in Quality Management.

Eric Barkley: He doesn’t have a LinkedIn but according to another study for which he was a co-author he is also an employee at Epic Systems.

I didn’t find a connection between these authors and GLP-1 manufacturers but I did learn that in February of this year, Epic signed Eli Lilly in its first pharma deal.

Methodology

This is a retrospective analysis in which the researchers looked at health records from patients who were on either liraglutide, semaglutide, or tirzepatide and then tracked their weight for 24 months after their chart showed drug discontinuation to determine their weight trajectory after ceasing the medication.

It’s important to know that the published article contains bold claims and graphs but almost no information as to the actual methodology and raw data. For that, you have to go to the top of the article, go to the end of the string of social media links and then click the blue circle with the arrow on it which opens up what I’m going to call the supplementary materials including most of the methodology information.

To be included, patients only had to have taken one of the three included GLP-1 drugs for at least 90 days, and lost at least 5 pounds while they were on the drug. They had to have weight readings between 30 days prior through 3 days after starting the GLP-1, within 30 days of stopping the GLP-1 and at least one weight reading 1 to 24 months following end of the GLP-1.

Already there is some stuff to unpack. Let me highlight that participants only had to lose five (5) pounds (an amount that some people who menstruate, for example, lose and gain every month) and even though they claim to be tracking weight for 24 months, the included patients only had to weigh in a single time during the 24 months that followed medication cessation to be included. Don’t worry, we’ll be coming back to this.

The original dataset (they are calling it the study population but I am not for reasons that will become clear in part 2) included 323,782 patients.

In terms of weight loss while on the drugs:

123,667 lost between 5 and 9 pounds
119,301 lost between 10 to 19 pounds
63,689 lost between 20 and 39 pounds
17,125 lost forty or more pounds

For the purposes of their reporting, the researchers divided the participants into groups based on their weight trajectory after they went off the drug.

In the article they say “Patients were grouped based on whether they regained weight, maintained their weight loss, or experienced further weight reduction.” Then they show graphs for each drug (liraglutide, semaglutide, and tirzepatide.) Here is how they defined those categories:

“Regained”: 100% of more of lost weight was regained
“Some Regain”: 25%-99% of lost weight was regained
“Maintained Loss”: Between 24% of lost weight was regained to 25% additional loss after discontinuation
“Additional Loss”: 25-100% more weight loss after discontinuation
“Doubled Loss”: More than 100% additional weight loss after discontinuation

More unpacking. They defined regaining 99% of the weight lost as “some regain” and it gets worse because they defined regaining 24% of the weight that someone lost as that person “maintaining” the weight loss. And they defined losing 25% more weight as “maintaining” weight loss. So per these researchers, if I started a race in first place and ended in 24th place I maintained my position or if I started a race in 25th place and ended in first place I “maintained” my position. That doesn’t have the ring of sound science (or basic vocabulary skills.) You may remember that the Eli Lilly tirzepatide Withdrawal researchers pulled a similar stunt claiming that anyone who didn’t regain more than 20% of the weight they lost had “maintained” their weight loss. Also remember that when the researchers for this study say people “doubled’ their weight loss people would have qualified if they went from 5 pounds lost to 10 pounds lost. Here again, the claim that two separate teams independently came up with this strains credulity in my opinion.

Also, the researchers only have medical records so if the patient switched from a prescription from their healthcare provider to an online service to get the same drugs it could have looked like they discontinued when they didn’t.

I think it would have been interesting to see how many people regained more weight than they lost (there is nothing wrong with being higher-weight or gaining weight, but there is an issue with a weight loss medication that comes with significant risks and can end with the opposite of the intended effect.)

In part 2 we’ll look at the study analysis which is where the train really flies off the tracks.

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.

Some of you may know that I’m a Board Certified Patient Advocate. I don’t currently do a lot of individual advocacy because my speaking schedule doesn’t allow for the necessary time availability so I typically either work on complex or emergency cases, or on cases that are not strictly timebound - most of these are people who are dealing with a BMI-based denial of care, meaning that their healthcare is being held hostage for a weight loss ransom. This is one of those situations and I am, as always, sharing this story with permission and anonymously by request.

I’ve been working with a patient who needs a Total Knee Replacement which was being denied based on a BMI cut-off. When the patient came to me they had already done everything I recommended for those self-navigating this situation. They had documented, in writing, that their surgeon said they “desperately need” a total knee replacement but wanted the patient to lose what amounts to 43% of their body weight and the stated reason was to “reduce anesthesia risk and post-operative complications.” Their surgeon had recommended the patient go on GLP-1s for weight loss and the patient did not want to take them but also didn’t want to continue to be in pain with severely limited mobility that was getting worse everyday. The surgeon agreed to see the patient again to discuss the case.

When I advocate, some patients want me to step in and talk to their doctor, others want consultation, scripting and/or help writing letters and other communication. This patient was the latter.

This would end up being the first opportunity I had to use the article about GLP-1s for weight loss that I co-authored with Angela Meadows and Louise Adams so before I tell the story, I want to offer some insider information about that research article.

Dr. Angela Meadows is an incredible educator and researcher and is the founder of the International Weight Stigma Conference. I’ve had the joy to know Angela for many years and this paper started when Angela was creating written testimony on GLP-1s for weight loss for an inquiry called “Prevention of Ill-Health - Ob*sity” by the Welsh Senedd (UK government) Health and Social Care Committee. She knew that I had been writing about the research and so we hopped on a zoom call and talked through the highlights of the analyses that I had done. A few months later, the Fat Studies Journal announced that they were putting out an edition focused on GLP-1 drugs and Angela suggested we make the testimony into a journal article. We pitched and they accepted and we were off to the races.

Angela very generously offered me the first author position because the testimony was built on my original analysis. Angela was the senior author - she has loads more experience than I do writing journal articles and Angela did most of the initial submission writing whileI dug into the trials data to create a set a tables for all of the semaglutide and tirzepatide trials that we included that showed the topline findings and the reality about weight loss and side effects, including in the semaglutide cardiovascular trial (we’re coming back to these tables later in this article.)

When we submitted for peer review they came back with a request that ultimately amounted to expanding the trials we included. So we expanded to all of the Phase 3 placebo controlled weight loss trials as well as the semaglutide cardiovascular trial (which we had included from the beginning) and the tirzepatide trial for those with heart failure with preserved ejection fraction. We also expanded our article to include even more information about Novo Nordisk’s marketing practices, at which point the brilliant Louise Adams came on as a co-author as this is one of her areas of expertise. While I was focused on the tables and baseline trial analysis and Louise was focusing on the info around Novo and marketing, Angela did more work digging into the literature, news stories, fact checking, and filling in the gaps, including a spectacular find that the tirzepatide trial for those with heart failure with preserved ejection fraction had changed their PRIMARY endpoint on the 55th revision, 3 years into the trial (perhaps because there were more deaths in the tirzepatide group than the placebo group and they were… not anxious to highlight that).

The paper was accepted and published and I am very proud to have been a part of it. I learned a ton from working with Angela through this process from beginning to end. If it feels like I’m belaboring this point it is because, as I’m first author, some people have taken to calling it my study, which is just not true.

Again, the research article is called GLP-1 medications for weight-loss: a triumph of marketing over patient care and you can find it here.

Back to the patient who needed knee surgery. I want to point out that the methods and conversations I work on for any patient are often very customized based on a combination of factors including the patient’s needs, wants, boundaries, and personality and the personality/behavior of the provider (when I have information about that) In this situation I had more information than I typically do about the provider including, for example, that this surgeon had been very open and honest with the patient, had taken a lot of time talking to her and didn’t make her feel rushed or like an annoyance, and was willing to take time to see the patient again. That is, unfortunately, FAR from being typical in my experience of these interactions.

Also, this experience has a happy ending but it definitely doesn’t always turn out like this. Medical weight stigma is rampant and it harms and kills higher-weight patients and one positive experience should never be used as an excuse to negate or minimize that. Medical advocates like me working with higher-weight patients is a band-aid at best, what we need is systemic change that sees bodies of all sizes as valuable and deserving of care and seeks to get better at caring for higher-weight bodies (including through research, tools, best practices, and provider attitudes), rather than deciding that if people can’t reach a certain BMI or weight then they deserve to suffer and even die. So please feel free to use/adapt this scripting but understand that this is in the US healthcare systems, and even within that healthcare system your experience may vary. Most importantly, know that is NOT your fault, the issue is the healthcare system, and patients (higher-weight or otherwise) shouldn’t have to fight to get care.

Here’s the full experience, the words in quotes are taken directly from a recording the patient made (with the surgeon’s permission) and shared with me, the information not in quotes is summarized from the recording to keep this post from becoming a novel, and the information about the surgeon’s attitude are from the patient’s perspective.

The patient began by confirming that the surgeon’s BMI limit required that the patient lose 43% of their body weight and that the surgeon recommended GLP-1s. The surgeon confirmed and the patient launched into our opening line: “Based on the current trial data for these drugs, what are the odds of my being able to lose 43% of my body weight, and how long will it take?”

To her great credit, the surgeon was honest that she did not know the answer.

At that point the patient referred her to the supplementary tables from Angela, Louise, and my article. The patient pointed out that for semaglutide, the STEP 1 trial only looked at weight loss up to 15% and 49.5% of the subjects failed to lose even 15% of body weight over 68 weeks and in the STEP 3 trial, even when combined with a restrictive diet, 64.3% of subjects failed to lose even 20% of their body weight over 68 weeks.For tirzepatide, the SURMOUNT 1 trial included weight loss up to 25% and 63.8% of the people on the maximum dose (15mg) failed to lose even 25% of their body weight over 72 weeks. In the 2-year weight loss analysis of the SELECT trial ( Ryan et al., 2024) 95.1% of patients failed to lose 20% of their body weight, average weight loss was down to 10%, and at four years the study had lost 89.5% of participants. The patient also pointed out that all of these trials assumed that patients were restricting food and exercising, and that other studies showed significant loss of muscle mass as part of the weight loss.

The patient reiterated to the surgeon that the surgeon’s own words were that the patient “desperately needed” a knee replacement and they asked our final question: “It looks like there is almost no chance that even with two years of these drugs and restricting food and exercise (that I current have restrictions around because of my knee), that I could lose the weight you want me to lose. With the amount of pain I’m in, possible muscle loss both from the drugs and from reduced activity due to pain, and the continued deterioration of my knee, can you help me understand how this makes sense from a risk/benefit perspective?”

There was a long silence from the surgeon. Then she exhaled and said “It doesn’t.”

The surgeon then pivoted to suggesting weight loss surgery, which I had talked about with the patient and so they were expecting. The patient pointed out that the surgeon was concerned about anesthesia risks which would still be a concern with weight loss surgery. The patient also pointed out that her knee issue would “make post-surgical ambulation, which is a key to reducing post-surgical complications basically impossible,” creating even more risk of the post-surgical complications that the surgeon was already concerned about. The patient also pointed out that a weight loss surgery has many short- and long-term risks and complications that the patient did not want to undertake, and that risking complications from two surgeries instead of one was also not something that the patient wanted to do.

The patient then shifted to a list of research that we had prepared from my list of research to fight joint surgery denials. (I also have lists for denials for gender-affirming procedures and lumbar spine surgery.)

The patient said “I understand that there may be a higher complication risk for a knee replacement at my current weight, but there are also serious dangers to waiting for surgery. I also know that there are surgeons who operate on patients my size, though there isn’t one who I can find who takes my insurance. So I’m asking if we can turn this conversation from a denial of care conversation to an informed consent conversation, including things I can do to optimize for surgery.”

It was at this point that the conversation took a pleasant turn (which, again, doesn’t always happen.) The surgeon acknowledged that the patient WAS optimized - they had quit smoking seven years ago, their blood sugar was well controlled and they were already doing seated exercise and working with a physical therapist regularly on their knee and their mobility. The patient and I had talked about pointing these things out but then the surgeon did it for them, so the patient just added the ending we came up with which was “many of these things could change in the future for lots of reasons including if I lost my job and/or insurance. I also understand that risks get higher with age. Wouldn’t it be better to do the surgery now?”

The surgeon said that she would check into things and get back to the patient. The patient threw in one last one of our talking points and suggested that if the anesthesiologist was concerned, perhaps one of the anesthesiologists who do anesthesia for the weight loss surgeries that the surgeon had recommended (and that are done at the same facility,) could step in. The surgeon said “Huh” delivered in a tone, according to the patient “as if it never occurred to her as a possibility.”

After several weeks of waiting and calling the office for updates, the surgeon approved a “one-time exception” to her BMI limit for this patient. Obviously, this isn’t as good as the surgeon changing her entire policy based on the new information she had, but it’s a start.

I certainly hope that others will be able to use Angela, Louise, and my article to support all kinds of advocacy and weight-inclusive work! More than that, I hope that someday it will not be necessary.

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.