How many $millions$ or even $billions$ have allergy and cold sufferers spent on a product known since 2015 to be ineffective? Congress passed the Combat Methamphetamine Epidemic Act of 2005, which restricted the sale of products containing pseudoephedrine, an effective decongestant that is also used for making methamphetamine. At the time, phenylephrine was touted as a safe and effective replacement, though even the FAQ from the Sudafed PE brand of phenylephrine back then was squishy — it used to say Q: Is phenylephrine as safe and effective as pseudoephedrine? A: Yes, phenylephrine is safe and effective. Not even the manufacturer claimed that Sudafed PE was as effective as original Sudafed (the question no longer appears on the current FAQ).
The effect of the law was to move products containing dry pseudoephedrine behind the pharmacy counter (liquid preparations weren’t as restricted; it’s probably harder to make meth from cough syrup or nasal spray than from tablets). You don’t need a prescription, but you have to have your driver’s license or state-issued ID scanned. Then you have to read and sign an electronic form about the restrictions. It’s intended to scare off meth producers, but I felt like I was being treated like a criminal the first few times I went through it. (At least they didn’t fingerprint me!)
Here’s the catch: phenylephrine was so ineffective that in 2015, University of Florida College of Pharmacy researchers analyzed previous study results, determined that oral phenylephrine was ineffective, and petitioned the FDA to review its status:
“I was director of a drug information center in a hospital at the time, and doctors and patients would call me and ask, ‘What is the right dose of phenylephrine?’” [Randy Hatton, Pharm.D., a clinical professor of pharmacotherapy and translational research] said. “We did not have an answer, but we determined through scientific evidence that the 10-milligram dose was insufficient.”
Hatton and [Leslie Hendeles, Pharm.D., a professor of pharmacotherapy and translational research and professor of pediatrics], along with Almut Winterstein, Ph.D., a professor of pharmaceutical outcomes and policy at UF, conducted a systematic analysis of previous studies and eventually petitioned the FDA to require better proof of efficacy and to reconsider the appropriate dosage of phenylephrine. The FDA convened its Nonprescription Drugs Advisory Committee and after much debate, ultimately requested a dose-response study of the treatment of nasal congestion. Hatton said Meltzer’s research was long overdue and reaffirmed the position that non-prescription oral phenylephrine provided little-to-no relief of nasal congestion.
“We think the evidence supports that phenylephrine’s status as a safe and effective over-the-counter product should be changed,” Hatton said. “We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people.”
If you’re interested, the analysis is here.
It’s now 2023, and an advisory panel just told the FDA, “Nope, stuff doesn’t work and should be pulled”:
The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.
[…] If the FDA follows through on the panel's recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.
Why did it take so long for the FDA to get a clue when allergy sufferers like me knew that phenylephrine didn’t do squat when taken orally the first time we tried it? (The linked piece notes that phenylephrine seems more effective when applied directly to the nose in sprays or drops, and those products are not under review.) Have the pharmaceutical companies even tried to come up with a better replacement? Just my uneducated guess — there wasn’t an equivalent drug available, but Big Pharma wanted people to buy their PE placebos, so they pressured the FDA to slow-walk the process on the grounds that a “suitable” replacement for pseudoephedrine already existed and hey, people were buying it, so don’t confuse them with facts — they might sue!
Well, guess what happened — some lawsuits have been filed over the ripoff:
A new lawsuit seeks damage payments for consumers in California and across the U.S. who bought over-the-counter medicines — for the relief of stuffy noses, colds and flu — that contain phenylephrine, which a regulatory panel on Tuesday said was ineffective as a decongestant.
[…] "Millions of Californians, and hundreds of millions of Americans, spend hard-earned money to purchase these products for help relieving congestion and other associated cold and flu symptoms because they are told by the (companies) that they work for that very purpose," according to the lawsuit filed this week in U.S. District Court in Sacramento.
The lawsuit claims the companies for years "have advertised and marketed the phenylephrine products to unsuspecting consumers despite knowing that phenylephrine is ineffective."
Plaintiffs Kenneth Levi Pack of Yolo County and Min Ji Jung of New York want the court to certify the case as a class-action, to bring into the lawsuit those who have bought any of the products at any time or location, including Californians who purchased them online. The lawsuit argues that the statute of limitations, which bars lawsuits over events too far in the past, should start at the point the U.S. Food and Drug Administration's expert panel this week issued its decision on phenylephrine.
The article notes that Pack and Jung are seeking payment of unspecified damages for themselves and everyone who bought the products. They also want a court order forcing the companies to engage in a "corrective advertising campaign," though that might be too much to ask. The FDA hasn’t ruled on the panel’s recommendations yet, so we’ll see.