Novo Nordisk's Ethically Questionable Wegovy Publicity Stunt

Touting study results with no study

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Embroiled in lawsuits and investigations across multiple countries about the dangerous side effects of their weight loss drug Wegovy (which I interrupted writing about to write about this,) Novo Nordisk put out a press release today with the headline “Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overw*ight or ob*sity in the SELECT trial.”

Normally I would be releasing a detailed breakdown of the study results. The problem is, the SELECT trial is not peer-reviewed or published in any way. I would love to dig into the comparator groups, the statistical analysis, and the outcomes, but I can’t. Nobody can. Novo Nordisk pushed out a press release with their claimed top-line result and then moved on with their day. This company, which has been sanctioned for its questionable and deceptive marketing tactics in the US and the UK, wants us to take their word for it.

I’m obviously not going to do that, but it seems like plenty of news agencies were more than happy to republish the headline with little to no context about the limitations of the study design (which is available) or the fact that the study hasn’t passed peer review or been published. Novo Nordisk has indicated that they will reveal the results at a conference at some later date (ostensibly after this thing gets through peer review) which, unlike simply publishing the results, will give them another opportunity to spin the narrative to their favor.

True to form, even Novo’s simple headline is riddled with ethical issues and questionable statements, so for now, let’s break down the headline and consider some things to watch out for when this study gets published (while remembering that by that time they will have already enjoyed a ton of free press touting unproven benefits of their drug, and a huge boost to their stock price.)

In general, when trials are funded and conducted by pharmaceutical companies, their methodology and conclusions should be viewed with heightened scrutiny, examined with a magnifying glass so to speak. I would argue that, based on their track record, every study funded and/or conducted by Novo Nordisk requires evaluation with an electron microscope.

The press release headline stated

Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overw*ight or ob*sity in the SELECT trial.

Semaglutide 2.4ng

Here my question is going to be, besides how many people dropped out outright, how many people were actually able to tolerate this dose? In previous studies, participants had to drop back down from this dose after being titrated up to it. Does the effect remain for those who have to take a lower dose to be able to tolerate life on this drug?

They mention in their study design that “The protocol is flexible to mitigate potential adverse effects and allows for elongated escalation and treatment pauses, if needed” How much did the protocol have to “flex” and how was that reflected in the findings?

I’m also concerned that this will be used as part of the, frankly, bullying behavior that people are reporting by doctors trying to convince them to tolerate what the patients consider intolerable side effects.

Reduces the risk of major adverse cardiovascular events

Their primary end point was a composite consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. These events are what their press release claims were reduced by 20%. Of course, the study only looks at a five-year period from when the study participants were randomized to when the study ended. Also, 20% is the RELATIVE risk which is known to be an inflated number. The ABSOLUTE risk (a number much more pertinent to individuals) looks to be less than 2%.

In adults with overw*ight or ob*sity

Here is where the ethics go from downhill, to off a cliff. This is misleading, at best. The study population included people at or over 45 years old (the threshold for “adults” is typically considered to be 18), with a BMI at or over 27 (the threshold for “overw*weight is 25 based on the deeply flawed BMI scale) and excluded anyone with Diabetes. Also, all study participants had “established cardiovascular disease” which they defined as having at least one: prior myocardial infarction, prior stroke (ischemic hemorrhage) or symptomatic Peripheral Artery Disease.

So, when they say “ adults with overw*ight or ob*sity” that does NOT include adults who are less than 45, who have diabetes, whose BMI is less than 27, and who don’t have established cardiovascular disease (along with an exclusion list that we’ll no doubt talk about when the study is released) They were not included in this trial and we don’t know if these results will extrapolate beyond the study population.

If you’re curious, making up your own criteria for terms that have an established meaning is not a research methods best practice (let alone using those terms in a misleading press release headline for an unpublished trial.)

So there’s a ton that we don’t know about this study (again, basically everything except what Novo Nordisk is claiming is the top line result.) What we do know is that Novo Nordisk’s stock prices jumped 17 points to record levels after this ethically questionable publicity stunt, aided and abetted by major news outlets that rushed to publish headlines repeating Novo Nordisk’s press release headline, with many articles glossing the fact that this was a press release and not actually study data, and accompanied by quotes from people who often have (undisclosed) financial ties to the company/industry.

One other thing I want to point out is that most of the writing about this assumes that being higher-weight causes higher cardiovascular risk. I just want to remind us that even if high-dose of Wegovy does reduce cardiac events for a very specific group of people over five years, that still does not mean that being higher-weight causes any higher risk that higher-weight people might have. We know that weight cycling increases the risk of cardiovascular disease, and that Novo Nordisk’s own studies show that weight cycling happens to nearly everyone who goes off the drug and many people even while they are on it.

Perhaps most importantly, this study design compares the results of those on the drug to people taking a placebo but, as is the case in nearly every study of weight loss interventions, they do NOT compare their results to a group of people utilizing weight-neutral, health-supporting interventions. This allows Novo Nordisk to create a false dichotomy - misleading people (including healthcare providers) into believing that people can either take this drug and get any health benefits it may (or may not) provide, or they can not take the drug and not get the benefits. This conveniently ignores that the truth may well be that the same (or greater!) benefits are available from weight-neutral interventions without the many risks (and significant expense!) of this drug.

No matter what the study actually says (and you can believe that I’ll start analyzing it the minute it comes out,) this press release is another example of the (Purdue Pharma and Enron-esque) limited-to-non-existent ethics of Novo Nordisk when it comes to marketing tactics that manipulate prescriber and patient behavior and their stock price.

EDIT: You can read the analysis of the actual study here (it’s actually worse than I had imagined.)

Editor’s note - apologies for the typo in the original title.

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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 Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.