STAT+: Pharmalittle: We’re reading about Novo Nordisk’s cautious culture, FDA approvals, and more
In the late 2010s, Novo Nordisk shelved a weekly obesity treatment that targeted three hormones at once, though it caused notable weight loss in mice
Good morning, everyone, and how are you today? We are doing just fine, thank you, despite rising temperatures and hazy skies looming over the Pharmalot campus. After all, the birds are still chirping and a cool breeze is wafting by. Moreover, our official mascots are snoozing somewhere on the premises. We can hear the heavy breathing. As for us, we are brewing more cups of stimulation — butter pecan is the choice today, for those keeping track — and we invite you to join us. Now, though, time to get cracking. Here are a few items of interest to help you on your journey. And may it be a good one. Talk soon.
In the late 2010s, scientists at Novo Nordisk developed a new weekly obesity treatment that targeted three hormones at once. In mice studies, the drug, which activated receptors of the GLP-1, GIP, and glucagon hormones, caused notable weight loss. But Novo shelved the therapy, STAT reports. The company was concerned about potential side effects of targeting glucagon, like increasing blood sugar and heart rate. Besides, Novo already had another obesity treatment in development that showed great promise — the GLP-1 drug semaglutide, now sold under the name Wegovy. Former employees cited various reasons why they think Novo was cautious: a conservative culture and history of investing less in R&D than peers; its belief in Wegovy, which may have blinded it to other drug candidates; and its desire to treat patients responsibly, given that it was the first to launch a new kind of obesity drug. As that molecule collected dust, though, Eli Lilly was rapidly moving along its own triple agonist, and today, the medication is in late-stage testing and seen as one of the industry’s most promising obesity drug candidates.
The vast majority of the 400-plus drugs approved by the U.S. Food and Drug Administration over a recent 10-year period failed to meet minimum standards proving they were effective, and many cause serious, sometimes even deadly side effects, The Lever and the McGraw Center for Business Journalism report. Nearly three quarters of drugs approved did not meet four foundational standards necessary to provide “substantial evidence” that the drugs would work as expected. More than half of drug approvals were based on preliminary data rather than sound evidence that patients had fewer symptoms, improved function, or lived longer. And 40 drugs met none of the four criteria. In particular, drugs intended to treat cancer were routinely approved without any real evidence that they work. Only three of the 123 cancer drugs approved met all four of the FDA’s scientific criteria. Nearly a quarter of the cancer drugs met none of the criteria. And 81% of cancer drugs were approved based on preliminary — and routinely unreliable — evidence rather than data showing patients would live longer or feel better.
