Pharmaceutical Executive
FDA slaps down Cheerios and forces pharma companies that use Google to make technical changes no consumer will ever notice. Big whoop.
My wife says I extrapolate too much from my own adolescence. She's undoubtedly right, but I still think my high school taught me at least one useful lesson about law enforcement: Left to their own devices, the enforcers will punish the relatively innocent and spare the truly guilty. Why? Well, obviously because it's so much easier to punish the relatively innocent. They're well-behaved. They buy into the rules, even if they sometimes run afoul of them. And that means, in turn, that their parents basically buy into them. The truly guilty see no reason to sit quietly in detention. They care nothing for their permanent record. Their parents don't necessarily care any more for the rules than they do. And if you're a teacher or principal, you need to be seen enforcing the law. So you enforce it on the enforceable, on the people who'll go along with the process, even if they aren't the ones who cause the most trouble.
I'd like to think the real world is different. But at times I wonder. In recent weeks, FDA has sent a rash of warning letters to pharmaceutical companies that failed to include safety information in their 10- to 15-word Google text-link ads, and admonished Cheerios for saying that a diet rich in whole grains is good for your heart, rather than saying that a diet rich in whole grains, fruits, vegetables, and fiber is good for your heart, as they are explicitly permitted to do.
Frankly, this sounds like high school all over again.
I spent some time today on Google, doing searches of disease names and watching what text link ads popped up. The pharma companies are all back—many of them were back within hours. They've stopped using their brand URLs, and are linking to sites, some of them branded, some not, with neutral sounding URLs. Is that an improvement? Maybe, though I tend to think not. I think it's better to acknowledge up front that a link takes you to a branded site. It seems fairer and more transparent. One way or another, the net change is pretty close to zero. Patients aren't safer or better informed. A regulation that could have meant one thing has been definitively declared to mean another. Big whoop.
Meanwhile, check out the rest of the text link ads that turn up. When I Googled "high blood pressure," I was led to a site that promised to lower cholesterol, blood pressure, and arthritis pain without drugs or side effects, using a $125-a-month drink full of herbs, vitamins, and minerals. "Rheumatoid arthritis" led me to a gent who promised he could cure the disease by purging the body of viruses with a $400 course of mineral salts. "Breast cancer"? A book that explains that the disease doesn't kill patients, chemotherapy does—plus an offer of 11 natural products that will eliminate cancer in just three months.
I could go on all day. Quacks, true believers, and villains are out there in force, advertising cures, making explicit medical claims, taking people's money, and talking them out of taking conventional, proven treatments. They sure look like they're violating the Food and Drug Act, and shutting them down would make a difference. Yes, it would be hard, but that's because unlike pharma and companies like General Mills, these outfits don't buy into the basic rules. That's not a reason to ignore them. It's a reason to stop them.
FDA is understaffed and underfunded, and it has vital work to do. Maybe it's time to stop noodling around with enforcement that doesn't change anything. We're not in high school anymore.
Patrick Clinton
Editor-in-chief
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.