As we enter cold and flu season, you might be planning to stock up on cold and flu medicines. Or maybe your shelves are already chock full of Sudafed PE, Mucinex, Dayquil, Tylenol Sinus, and Advil Sinus Congestion. If so, you might just want to switch to your favorite off-brand placebo.
New Findings About the Effectiveness of Cold Medicines
The FDA has found that the active ingredient in all these drugs, called phenylephrine, isn’t actually effective at treating nasal congestion.
Since 2006, phenylephrine has been the only GRASE (“generally regarded as safe and effective”) over-the-counter oral nasal decongestant. Other candidates are either behind-the-counter (like regular Sudafed, whose active ingredient is an amphetamine) or have been deemed unsafe altogether.
But when taken orally, phenylephrine doesn’t outperform a placebo. In response to the summary of studies done on phenylephrine, the American Association of Colleges of Pharmacy has recently supported the request to revoke phenylephrine’s GRASE status because it lacks the “E” And in early September of this year, the Nonprescription Drug Advisory Committee, at their meeting to discuss the efficacy of phenylephrine, unanimously felt that it should not be deemed GRASE by the FDA. .September 11-12, 2023 Nonprescription Drugs Advisory Committee Meeting (fda.gov). While the FDA doesn’t have to follow this recommendation, it is quite likely that it will, in which case these products will be pulled from shelves.
That this type of cold medicine isn’t all that effective should come as no surprise. In 2006, the Journal of Allergy and Clinical Immunology published an article describing phenylephrine as an “ineffective replacement pseudoephedrine.” In other words, when Sudafed was forced to go behind-the-counter in 2006 because it was being used to illegally manufacture methamphetamines, switching to the newly available Sudafed PE wasn’t really going to help those who were actually seeking relief from their cold symptoms. One of the major studies to find that phenylephrine a waste of money was all the way back in 2015, something that was widely published in news outlets at the time. Even the FDA had acknowledged that the evidence was merely “suggestive” that the drug was effective.
While it does not appear that the active ingredient is unsafe, its side effects include high blood pressure, nervousness, headaches, and insomnia. So, if you’ve been unable to sleep due to nasal congestion, it may have been your decongestant all along.
The issue may have to do with the oral administration of the medicine. When taken as a pill, less than 1% of the drug seems to end up where it can be useful to the body. The FDA was clear to point out that their findings are not related to the nasal spray administration of phenylephrine.
The Future of Big Pharma
If you’ve wasted money on these oral decongestants, you’re not alone. According to the FDA, products with phenylephrine were sold 242 million times last year, at a cost of $1.76 billion. These numbers are three to four times as high as the behind-the-counter option. Phenylephrine is big business, but it might also be grounds for big class action lawsuits. J&J unit, P&G, Walgreens misled consumers about decongestants, lawsuits say | Reuters
The manufacturers of these phenylephrine products, including Procter & Gamble, Walgreens, and Johnson & Johnson’s healthcare spinoff Kenvue Inc., have been accused of deceiving consumers about the effectiveness of their cold medicines in a series of new class action lawsuits. If the lawsuits prevail, these companies will not only have to pay out damages to consumers, but also divulge just how long they knew about the ineffectiveness of their products. It appears that Johnson and Johnson should have known about the ineffectiveness of phenylephrine at least since one of their trials showed that it was no better than a placebo back in 2018. Despite having plenty of evidence to suggest that their products were ineffective, Johnson and Johnson continued to sell them to consumers, amounting to fraud, one suit alleges.
This is not the first (and probably won’t be the last) time that pharmaceutical companies will face claims about the ineffectiveness of their products. Remember Zicam?–those “pre-cold” medicines that promised to reduce the duration of your cold? Well, the company behind the product line found itself paying out millions in class action settlement in a case that alleged it engaged in false advertising when their product was found to be no more effective than a placebo. Placebos seem to be a constant thorn in this particular industry. Readers of Ben Goldlacre’s Bad Science: Quacks, Hacks, and Big Pharma Flacks know just how flimsy much of the “scientific” backing is to the effectiveness claims of many homeopathic medicines or pharmaceutical products.
However, in this particular case, the way in which a nasal decongestant’s effectiveness was measured changed in the scientific community since phenylephrine was first deemed GRASE by the FDA in 1976. As better measures and tests came about in the decades since, the drug no longer outperformed placebos–only, the marketing departments didn’t get the message. So, the products continued to be sold under the auspices of outdated medical findings.
It’s possible that the same thing may occur with other drugs. Will these companies proactively eliminate revenue streams in advance of the FDA getting around to effectively pulling them from the shelves? Or, perhaps scientific standards will themselves change. Would the FDA one day accept that marketing claims attached to products can themselves trigger positive placebo effects?–probably not, especially if further class action suits can prevent those claims in the first place.
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