Dubious Justifications Behind Request to WHO to Declare Diet Drugs "Essential" Part 2

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In part 1 we talked about a request that has been submitted for the World Health Organization (WHO) to add diet drugs to their list of “essential medicines.” We discussed who was making this request and the justification that they were using. Today we’re going to take a deeper dive into the research that they used to try to support this request, and in part three will look at the research around harm and “efficacy,” as well as “cost effectiveness.” (I was originally going to write this in two parts, but I realized that it was just ridiculously long, and there is time before the WHO meets about this, so I’ve decided to break it into three parts.)

Just a reminder that I don’t hyperlink to studies or articles that come from a place of weight stigma, though I do provide enough information that someone could google them.

In their ”Summary statement of the proposal for inclusion” they say

“The use of GLP-1 RAs in the treatment of ob*sity has been well studied and meta-analyses of various GLP-1 RAs have demonstrated that this class of medications can lead to clinically significant weight loss. Compared to control groups, GLP-1 RAs were found to lead to more significant weight loss with a mean difference of approximately 7.1 kg as well as an improvement in glycemic control, with low concern for hypoglycemia[3].”

The single paper they cite to back this up (Iqbal et al. Effect of glucagon-like peptide-1 receptor agonists on body weight in adults with ob*sity without diabetes mellitus-a systematic review and meta-analysis of randomized control trials, 2022) looked at weight loss on these drugs among “ob*se” adults without type 2 diabetes (so hypoglycemia would have been unlikely anyway.) It included 12 trials with a total of 11,459 participants. 80% of the participants were white, 10% were Black or African Americans and 5% were Asians. It is concerning that they are making a global recommendation based on a study population that is overwhelmingly white.

There is also the issue of follow-up. Some of the trials were as short as 14 weeks and the longest trial included was only 3 years. The average weight loss was 15.6 lbs more in the group taking the drugs than in control, but some subjects on the drugs lost as little as 5.5 lbs. Those on the drugs also experienced vomiting, nausea, dyspepsia (indigestion,) diarrhea, constipation and abdominal pain as common side effects. There is no way to know how much of this (short-term) weight loss is due to experiencing these common side effects. These drugs also have significant (possibly life-threatening) side effects and the short-term follow-up included here is not likely long enough to capture those. Also, remember that the recommendation is for people to take these drugs for the rest of their lives (since, if they don’t, their weight shoots right back up and they lose cardiometabolic benefits,) and they are making that recommendation (globally) on just 14 weeks to 3 years of data.

The authors of this study cite no conflicts of interest. Per LinkedIn, someone with the same name as the lead author is a product specialist at Novo Nordisk but I imagine that must be a coincidence or surely it would have been listed as a COI. The article was published in “Ob*sity Reviews” which is an official journal of the “World Ob*sity Federation” (WOF). The WOF took over $5.3 Million dollars from Novo Nordisk (whose weight loss drugs are covered by this recommendation) over three years. Their “members” include the Ob*sity Action Coalition (whose chief funder is Novo Nordisk.) Their current President has taken money to speak on behalf of Novo Nordisk and their past president is John Wilding who was implicated in the recent Novo Nordisk scandal for not disclosing his financial ties to Novo Nordisk while praising their weight loss drugs in the media.

There are more issues with this meta-analysis but I’ll just stop there and say that I don’t think there is any way that 14 weeks to 3 years of data on 11,459 people who are mostly white justifies a global recommendation of these drugs as “essential.”

Under “Treatment details (requirements for diagnosis, treatment and monitoring)”

Here again they say “Ob*sity, a preventable disease” but offer no citation or support for this narrative that has been largely architected and marketed by the weight loss industry. They continue:

“When used in supplement to life style modifications, including a decrease in caloric intake and an increase in exercise, liraglutide is indicated for adults with ob*sity (BMI >30.00) or overweight (BMI >27.00) with a weight-related comorbidity”

I just want to note here that this indication (which wasn’t created by those who wrote the recommendation to the WHO) predicates risk on body size and simple correlation. These drugs have very unpleasant common side effects and other, possibly life-threatening, side effects. So the fact that those who are “overw*ight” have to have at least one condition that is correlated with being higher weight (with no proof of causation, by the way) but those who are “ob*se” are recommended to risk these side effects based on size alone, with no required symptomology, is pure weight stigma.

Next is a table “Excerpts from national and international guidelines on the pharmacological treatment of ob*sity”

It is a list of organizations with quotes pulled from various publications that are intended to show support for the drugs. Almost every one of the organizations has financial ties to Novo Nordisk and/or Eli Lilly which doesn’t prove that there is anything shady going on, but would be worth disclosing given their use to back up the request that these companies’ drugs be considered “essential.” Let’s take a deeper look:

The American College of Cardiology (ACC)

The recommendation that is cited is for the use of these drugs for Type 2 diabetes (T2D), and they mention weight loss as an ancillary effect. This will be a pattern in these recommendations and it matters because the risk/benefit analysis is different for people who have an actual health condition (Type 2 diabetes) rather than those who are simply living in a higher-weight body. Also, one might be misled by the title of the section to believe that these recommendations are specifically for the use of the drugs in the treatment of “ob*sity” which is not the case.

The ACC has a partnership with Novo Nordisk

They have also partnered with Eli Lilly

South Asian Task Force

Again, this is a recommendation for these medications for the treatment of T2D, not for weight loss.

The paper’s lead author, Sanjay Kalra has received honoraria for lectures and advisory boards from Eli Lilly and Novo Nordisk.

International Diabetes Federation

This, again, is a recommendation of these drugs for the treatment of T2D.

Novo Nordisk is a “platinum partner” and Eli Lilly is a “gold partner” (the website isn’t clear about how much money they donate, and an email I sent has gone unanswered so far.)

National Institute for Health and Care Excellence (NICE)

This one actually is a recommendation for these drugs for weight loss, however, NICE was implicated in the recent scandal which found that “Novo Nordisk had paid millions to prominent ob*sity “charities,” NHS trusts, universities and other bodies as well healthcare professionals who publicly praised the drug (typically without disclosure of their funding) and who advised NICE (The National Institute for Health and Care Excellence) on their reviewing of Novo’s weight loss drug to decide whether or not it should be made available.”

Position statement from the Brazilian Diabetes Society (SBD), the Brazilian Cardiology Society (SBC) and the Brazilian Endocrinology and Metabolism Society (SBEM)

This is a statement of recommendations for prevention of cardiovascular disease in patients with diabetes.

Here is a selection of the authors “competing interests” (I’ve only included Novo Nordisk and Eli Lilly, the two main companies trying to sell this class of drugs for weight loss.)

ROM has received speaker honorarium from: Novo Nordisk and Eli Lilly.

CMV has received honoraria as speaker from Novo Nordisk.

SV over the last 5 years, has received honoraria for clinical research from Novo Nordisk; Advisory Board to Novo Nordisk; has received honoraria as speaker from Novo Nordisk

FT has received honoraria for medical lectures from: Lilly, Novo Nordisk

RDS over the last 3 years has received honoraria for consulting, research and speaker activities from Eli Lilly

The Brazilian Diabetes Society (SBD) has collaborated with Novo Nordisk

The Brazilian Cardiology Society (SBC) holds an annual congress that is sponsored by Novo Nordisk and Eli Lilly.

The Brazilian Endocrinology and Metabolism Society (SBEM) has partnered with Novo Nordisk on multiple occasions.

Korean Society for the Study of Ob*sity Guidelines for the Management of Ob*sity in Korea

This is not a study but guidelines put out by an organization that appears to represent those with a profit interest in “ob*sity treatment” (similar to the Ob*sity Action Coalition.) Their “recommendation” includes every drug that is approved for long-term use, fails to cite any evidence of efficacy (short or long-term) and they mention that “Not all ob*se people respond to ob*sity drugs, and there are a significant number of non-responders.”

Novo Nordisk is a platinum sponsor for their conference. They are also a member of the World Ob*sity Federation which took over $5M from Novo Nordisk.

European Medical Association[sic]

Here they are citing a press release stating that the European Medicines Association (EMA) (the recommendation authors appear to have been mistaken on the name) has “recommended granting a marketing authorisation for Saxenda (liraglutide) for weight management in overweight or ob*se adults.”

Per the EMA’s website they are “a scientific body with the expertise required to assess the benefits and risks of medicines. However, under EU law it has no authority to actually permit marketing in the different EU countries. The role of EMA is to make a recommendation to the European Commission which then takes a final legally binding decision on whether the medicine can be marketed in the EU.”

I could not find information about the panel that made the decision, or any conflicts of interest they may have had.

Australia: NPS Medicine Wise

The citation they offer here is not to Australia: NPS Medicine Wise, but to a paper by a single author - Joseph Proietto who “has been on the medical advisory boards for liraglutide, semaglutide 2.4 mg and bupropion/naltrexone. He has been involved in educational sessions for ob*sity management for both Novo Nordisk (liraglutide, semaglutide) and iNova (phentermine and bupropion/ naltrexone) for which he has received honoraria.” In other disclosures it mentions that he was, in fact, chair of the medical advisory board for Saxenda (Novo Nordisk’s brand name for liraglutide, the drug being recommended here.)

In the paper he recommends all of the above weight loss drugs in general, but does not recommend the GLP-1 class of drugs over any of the others. The study he uses to recommend these drugs only follows participants for 68 weeks.

Singapore HPB-MOH Clinical Practice Guidelines

In the section on liraglutide they offer information for 56 weeks of follow up and conclude “The long-term safety of high dose liraglutide therapy is, however, unclear.”

Canadian Medical Association Journal- Ob*sity in adults: a clinical practice guideline

Funding for these guidelines was provided by Ob*sity Canada, an organization that lobbies for the priorities of those who profit from “ob*sity treatment.” Specifically, the funds came from “Ob*sity Canada’s Fund for Ob*sity Collaboration and Unified Strategies (FOCUS) initiative” Novo Nordisk is a supporter of this fund, as well as a sponsor for their annual summit.

Here are excerpts from the 1,293 word competing interests statement for the authors (I’ve only included Novo Nordisk and Eli Lilly, the two main companies trying to sell this class of drugs for weight loss.)

Sean Wharton reports receiving honoraria and travel expenses and has participated in academic advisory boards for Novo Nordisk, Eli Lilly. Sean Wharton is also the medical director of a medical clinic specializing in weight management and diabetes.

David Lau reports receiving grants and research support from Novo Nordisk, speaker bureau fees from Eli Lilly and Novo Nordisk; and consulting fees from Eli Lilly and Novo Nordisk.

Michael Vallis is a member of advisory boards for Novo Nordisk. Michael Vallis has also received consulting fees from Novo Nordisk and speaking fees from Novo Nordisk.

Arya Sharma reports receiving speaker’s bureau and consulting fees from Novo Nordisk.

Laurent Biertho is a member of advisory boards for Novo Nordisk.

Denise Campbell-Scherer reports receiving research funding from Novo Nordisk. She also reports receiving an unrestricted education grant from Ob*sity Canada, funded by Novo Nordisk Global.

Jennifer Brown reports receiving nonfinancial support from Novo Nordisk, and personal fees

Yoni Freedhoff is the co-owner of the Bariatric Medical Institute and Constant Health, which provide weight management services; Constant Health has received a grant from Novo Nordisk. Yoni Freedhoff also regularly speaks on topics related to ob*sity and receives honoraria and travel costs and expenses for same.

Michel Gagner reports receiving consulting fees from Novo Nordisk.

Marie-France Langlois reports receiving personal fees from Novo Nordisk, Eli Lilly.

David Macklin reports receiving personal fees from Novo Nordisk.

Priya Manjoo reports receiving personal fees from Novo Nordisk.

Marie-Philippe Morin reports receiving speaker honoraria from Novo Nordisk, Eli Lilly and research subvention from Novo Nordisk, and consultation honoraria from Novo Nordisk, Eli Lilly.

Sue Pedersen reports receiving personal fees from Novo Nordisk, Eli Lilly and grants from Eli Lilly, and nonfinancial support from Novo Nordisk and Eli Lilly.

Megha Poddar reports receiving honoraria for continuing medical education (CME) from Novo Nordisk, Eli Lilly, education grants from Novo Nordisk, fees for mentorship from Novo Nordisk; fees for membership of advisory boards from Novo Nordisk.

Paul Poirier reports receiving fees for consulting and continuing medical education from Eli Lilly, Novo Nordisk.

Judy Shiau reports receiving personal fees from Novo Nordisk.

Diana Sherifali reports receiving a grant from Ob*sity Canada to support the literature review process, during the conduct of the study.

Shahebina Walji reports receiving consulting or advisory board fees from Novo Nordisk and speaker’s bureau fees from Novo Nordisk.

All of their recommendations around liraglutide are level 2a (Evidence from at least 1 controlled study without randomization) and Grade B ( Directly based on level 2 evidence or extrapolated recommendation from category 1 evidence) they suggest that these recommendations should use the terms “may” or “can” (as opposed to “should.”) The studies that they cite offer, at most, only 56 weeks of follow-up.

Information supporting the public health relevance

In this section they claim that “not only is the prevalence of ob*sity increasing, but the number of global deaths attributed to BMI has substantially increased from 1990 to 2017 (Figure 1) [23]. The global burden of disease of ob*sity study also found that though the age-standardized rate of high BMI related disability adjusted life years (DALY) increased by 12.7% for females and 26.8% for males, the actual global number of high BMI DALYs has doubled, despite sex”

The study that they cite to support this (The global burden of disease attributable to high body mass index in 195 countries and territories, 1990-2017: An analysis of the Global Burden of Disease Study, Dai et al., 2020) calculates these numbers based on the assumption that the health problems higher-weight people have are due to their weight (even though people of all sizes experience them). They also fail to control for the health impacts of weight stigma, weight cycling, or healthcare inequalities, despite the research that shows that they are confounding variables. The assumption that higher-weight people’s health issues are caused by their weight coupled with the failure to account for (or even discuss) confounding variables suggests to me either near-complete incompetence of the study authors around basic research methods, or a desire for specific conclusions.

The study is at least honest that they don’t know if weight loss would change this, stating “Successful population-wide initiatives targeting high BMI may mitigate the burden of a wide range of diseases” [emphasis mine].

Thus, this doesn’t actually support the recommendation to the WHO. Without proof that these medications would reduce disease or increase life years long-term, there is no reason to consider them “essential,” and no such evidence exists.

Next they claim that “Ob*sity also plays a role in health care related costs; for patients and families, total healthcare costs for patients with ob*sity were higher than that of patients who are overweight.”

First of all, this begins to wade into the idea that higher-weight people should be eradicated because they are “too expensive,” which is heading down a bad road when it comes to ethics. Further, the study they use to support this is based on 97 Dutch people who filled out a survey. The study included costs such as “expenditures related to the respondent’s weight, such as adapted clothing, gym subscription, diet books, parking permit, food, etc.” First of all, thin people also have gym subscriptions and parking permits, but, moreover, telling fat people that they should buy diet books and pay for various weight loss foods and methods (despite the near-total failure rate,) then blaming them for the cost of following those dubious recommendations (as well as the additional costs of living in a world where structural weight stigma creates a lack of accommodation in clothing etc.) as a justification for more expensive, more dangerous “interventions” is a long way from being ethical science and is a particularly craven marketing tactic.

I’m just going to stop there, but to say that I’ve seen elementary school science fair projects with more rigorous methodology and I would be beyond embarrassed to cite this for any reason ever, other than as an example of the piss-poor state of weight science.

They finish up the section with “Given the global burden of ob*sity and the goal of reducing preventable disease related deaths, it is evident that affordable and available pharmacotherapy for ob*sity is needed on a global level.”

Let’s rephrase this to reflect the evidence they provided:

“Based on a survey taken by 97 people, a study that failed to control for any confounding variables and made wild assumptions about causality based on simple correlation, and their own research’s acknowledgment that changing body size may not change health outcomes, it is evident that affordable and available pharmacotherapy for ob*sity is needed on a global level.”

Which is to say, what they provided here does not come close to justifying their request.

In part three we’ll wrap this up with a look at the evidence they use to discuss harm, effectiveness, and cost-effectiveness.

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More research and resources:
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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.