Episode Details

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Novo Nordisk (the same company that made a literal fortune by price gouging with insulin,) has taken another step to follow through with their promise to shareholders to generate massive profit from their new weight loss drug Wegovy by getting FDA approval to market the drug to adolescents ages 12 and up.

This approval is based on a 68-week trial. They started with 210 participants who were randomized 2 to 1 to get the drug or a placebo, with 180 completing the full 68 weeks.

At week 68, a total of 95 of 131 participants (73%) in the semaglutide (Wegovy) group had weight loss of 5% or more. The youth subjects had greater incidences of gallbladder problems including gallstones, low blood pressure, rash, and itching compared to adults treated. The most frequently reported adverse reactions were nausea, vomiting, diarrhea, headache, and abdominal pain.

There are some obvious things here.

First, according to disclosures, every single researcher on the trial takes money from Novo Nordisk. That’s not proof of impropriety, but it’s certainly something to know (You can find a quick guide to evaluating weight science research here.)

Second, it shouldn’t be shocking that a drug that causes nausea, vomiting, diarrhea, and abdominal pain will also lead to, at least short-term, weight loss. In other studies of similar GLP-1 agonists we have seen that higher amounts of weight loss are predicted by longer onset of gastrointestinal symptoms so there is some question as to how much of the weight loss is the action of the drug on hormones and slowed digestive motility, and how much is just about giving people flu-like symptoms.

Third, at 68 weeks this is a relatively short-term study. In a follow-up to the 68 week adult study of the same drug (Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension,) one year after they had stopped the drug, participants had regained two‐thirds of the weight loss they lost, and lost about two-thirds of their cardiometabolic improvements. This is in line with the significant data showing that almost every weight loss attempt ends in full weight regain within 2-5 years, and it means that, in addition to the side effects of the drug, it may also be exposing those who use it to the risks of weight cycling.

Their follow up from weeks 68 (when the adolescents stopped the medication) until week 75 shows a similar pattern.

Novo Nordisk’s (incredibly profitable for them) answer to the fact that people regain weight after going off the drug, is that they should just stay on the drug, forever. This is a problematic recommendation at best for adults, especially considering it’s only based on a 68-week trial during which participants experienced serious side effects including pancreatitis, gallstones, kidney failure, increased heart rate and depression or thoughts of suicide and a risk of tumors that earned Wegovy a boxed warning – the FDAs strongest warning.

When it comes to children, I think it’s likely far worse. Remember that this is a drug for Type-2 diabetes that was repurposed by Novo Nordisk when they found that weight loss was a side effect and that the market for weight loss drugs was significant. It also allowed them to capitalize on their long-game efforts of having simply existing in a higher-weight body cons