OPINION:
On Sept. 24, the Senate Health, Education, Labor and Pensions Committee, under Chairman Bernie Sanders, will hold yet another made-for-TV hearing on the increasingly important role that prescription drugs such as Ozempic, Wegovy and Mounjaro are playing in the battle against our nation’s twin epidemics of diabetes and obesity.
But that’s not what the hearing will be about. Consider the hearing title: “Why Is Novo Nordisk Charging Americans With Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” This won’t be a serious conversation. It’s just another opportunity for Mr. Sanders, Vermont independent and self-proclaimed “democratic socialist,” to pound the lectern and declare yet another reason why we need a single-payer (government-run) health care system nationwide.
What else is new?
Well, what’s new is that the remarkable success of these drugs in addressing their labeled indications is being ignored by a large swath of physicians and pharmacists who are writing and dispensing more cosmetic prescriptions than health-related ones. Want to get into that dress for your niece’s wedding? Is your suit too tight for that fundraiser? Those aren’t the kind of labels for which these pharmaceuticals are intended.
And they’re certainly not intended to be compound-manufactured by local pharmacies. The Food and Drug Administration says it has received “adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”
Compounding pharmacies aren’t pharmaceutical companies. Providing patients with unapproved, unregulated products is illegal and dangerous. “Let the buyer beware” isn’t acceptable when it comes to fitting into a pair of pants or zipping up a designer dress.
In addition, the FDA “has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.”
Pharmaceuticals such as Ozempic, Wegovy and Mounjaro aren’t risk-free. The FDA says it has received reports of people overdosing on compounded semaglutide, giving themselves as much as 20 times the intended dose of the medication. Is the juice worth the squeeze? The FDA doesn’t think so.
Why aren’t pharmacy boards and the federal government doing more to address these issues? What about the economic impact of these prescription drugs on long-term patient outcomes? These would be good questions for Mr. Sanders to ask witnesses from the National Association of Boards of Pharmacy, an FDA drug safety expert or a health care economist such as Tomas Philipson of the University of Chicago.
Unfortunately, the only witness at this hearing is Lars Fruergaard Jørgensen, CEO of Novo Nordisk. And it’s not because of his drug compounding, pharmacoeconomics or adverse event reporting expertise. What a missed opportunity.
Just because we want to believe that compounded versions of these pharmaceuticals are safe and effective doesn’t make them so. Unfortunately, physicians and compounding pharmacies offering a regulatory end run to slimness are just another part of the misinformation crisis facing the FDA. Actions have consequences.
Mr. Sanders has a high-visibility moment to address the growing velocity with which irresponsible pharmacies and websites are selling illegal and unsafe prescription drugs — and he’s going to waste it on the same policy silliness that perpetuates the fantasy of lower pharmaceutical prices via drug importation (another ill-considered and simplistic Sanders talking point).
In closing, let’s get biblical. It’s all the more peculiar that the Senate committee hearing is on Sept. 24, since Mark 9:24 discusses overcoming unbelief. As the father of a sick child asked Jesus, “I believe; help my unbelief.” Mr. Sanders, help the American public overcome its disbelief in the FDA. Do the right thing and stop playing politics with health care.
• Peter J. Pitts, a former associate commissioner at the Food and Drug Administration, is president of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine.
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