One of the more impressive corporate grifts of recent decades — various pharmaceutical companies profiting by selling cold remedies they surely knew were useless — is finally coming to an end:
After spending decades on pharmacy shelves, the leading nasal decongestant in over-the-counter cold and allergy medicines has met its downfall.
Advisers for the Food and Drug Administration this week voted unanimously, 16 to 0, that oral doses of phenylephrine—found in brand-name products like Sudafed PE, Benadryl Allergy Plus Congestion, Mucinex Sinus-Max, and Nyquil Severe Cold & Flu—are not effective at treating a stuffy nose.
The vote was years in the making. In 2007, amid doubts, FDA advisers called for more studies. With the data that has trickled in since then, the agency’s scientists conducted a careful review and came to the firm conclusion that oral phenylephrine “is not effective as a nasal decongestant.”
Looking back, the FDA noted that key data supporting its original acceptance of phenylephrine in 1976 was likely “too good to be real.” And looking forward, the agency saw a bleak future for the drug. While this week’s vote concluding ineffectiveness applies only to the oral dosages currently approved for use, the FDA found that higher, potentially more effective doses of the drug could significantly increase blood pressure, posing a safety risk. “[T]here may be no path to evaluating higher doses,” the agency concluded.
I’m reminded that the “data” cited by the Sacklers to claim that OxyContin wasn’t addictive consisted of a letter to the editor.
And while cold remedy that doesn’t work has allowed for a great deal of profit-taking, an apparently effective medication isn’t considered profitable enough to sell in America:
“We have something much better,” the pharmacist said. As I wrote last December in the Prospect, ambroxol works on an entirely different biochemical principle, to thin sputum and facilitate productive coughing, and also operates as a pain reliever and gentle decongestant with no rebound effect. My wife and I experienced it as a miracle drug for coughs and colds. A box cost eight euros.
Why is ambroxol not available in the U.S.? A comprehensive review published by NIH in 2020 found it safe and effective.
But no drugmaker has ever sought FDA approval, a time-consuming process requiring three stages of clinical trials. Why not? Because drugmakers could not make enough money with a generic to justify the expense. It’s obviously crazy to require this laborious review process for a generic that has been widely used in Europe since 1978, but this is how our system works.
Here is where President Biden could come to the rescue of cold-sufferers. He could direct the FDA to fast-track the approval of ambroxol for sale in the U.S.
Will be interesting to see whether the data for ambroxol holds up and if it’s approved for American sale.