The Phenylephrine Conspiracy: When Profit Trumps Effectiveness

An Ineffective Decongestant

In a rather unsurprising turn of events, a Food and Drug Administration advisory panel concluded on Tuesday that a key ingredient in many over-the-counter cold and allergy medications, phenylephrine, is about as useful as a chocolate teapot when it comes to getting rid of nasal congestion. The panel's unanimous vote, singling out oral formulations of phenylephrine as utterly ineffective, is set to send shockwaves through the market for OTC cold and allergy remedies – where consumers, for some inexplicable reason, overwhelmingly prefer pills over nasal sprays.

The Looming Profit Over Patients

Phenylephrine, that ubiquitous underachiever, is a common ingredient in various drugs, including Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion. Despite its stellar reputation for generating nearly $1.8 billion in sales last year in the United States, it turns out this drug might be little more than a placebo. According to the FDA's findings, when phenylephrine is ingested orally, it's about as effective at clearing nasal congestion as a whisper in a hurricane.

Unsurprisingly, some people are not shocked in the slightest. Susan Blalock, an advisory committee member and a retired professor at the UNC Eshelman School of Pharmacy, said, "The evidence is pretty compelling that this medication is not effective. I don’t think additional data are needed to support that conclusion." But hey, who needs compelling evidence when you've got profits to safeguard?

Now, the FDA faces a tough decision. Should it revoke phenylephrine's OTC designation as "generally recognized as safe and effective"? This designation, typically reserved for older drugs, conveniently allows drugmakers to include an ingredient in OTC products without bothering with pesky FDA applications. Without this cherished designation, products containing phenylephrine may find themselves booted off the shelves, or manufacturers might have to concoct new, actually effective formulations. When the FDA will make its final decision remains a closely guarded secret. But here's a hint: they usually side with their advisory committees, especially when those committees spell out "ineffective" in giant neon letters.

But why, you might ask, was this lackluster drug allowed to linger on the market for so long? Jennifer Schwartzott, a patient representative from New York, wondered the same thing. She rightly observed, "This drug and this oral dose should have been removed from the market a long time ago." Unfortunately, patient safety sometimes takes a backseat to profit margins.

Phenylephrine rose to fame in the early 2000s as a replacement for pseudoephedrine, which had its own set of issues. Pseudoephedrine was the decongestant used in Sudafed but was moved behind the pharmacy counter in 2006 because it had a knack for being used to make methamphetamine. And we wouldn't want the inconvenience of having to ask a pharmacist to get in the way of our desire for an ineffective drug, now, would we?

During a riveting two-day meeting, FDA scientists presented the results of five studies conducted over the past two decades, all of which concluded that oral phenylephrine is about as useful as a trapdoor on a lifeboat. They also re-evaluated the initial findings used to support its OTC use, and surprise, surprise – the agency found that these results were inconsistent, outdated, and possibly about as reliable as a rubber crutch.

Dr. Peter Starke, an FDA official who led the review of phenylephrine, delivered the final blow: "In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant." So there you have it, folks, it's not just ineffective; it's also scientifically outdated.

But it gets even better – or worse, depending on your perspective. Phenylephrine, in addition to being a placebo, comes with side effects like headaches, insomnia, and nervousness. At higher doses, it can even give you the gift of elevated blood pressure. So, not only does it not work, but it might also make you feel worse. Talk about a two-for-one deal!

Now, you might be wondering if nasal spray phenylephrine is any better. The advisory panel isn't questioning its effectiveness, so there's still a sliver of hope for temporary congestion relief – but don't get your hopes up too high.

Surprisingly, representatives for the Consumer Healthcare Products Association, a group representing OTC drug manufacturers, didn't even attempt to put up a fight. Instead, they offered a survey claiming that 1 in 2 households in the U.S. used an oral decongestant in the last year. They also suggested that people prefer oral decongestants over nasal sprays by a margin of 3 to 1. Because, clearly, what people prefer is always what's best for them, right?

And here's the kicker: they argued that effective alternatives wouldn't be as readily available. Of course, this assertion was promptly challenged by advisory committee members. Dr. Maryann Amirshahi, a committee member and a professor of emergency medicine at Georgetown University School of Medicine, pointed out the obvious, saying, "We do have an effective alternative in pseudoephedrine." But of course, why settle for effective alternatives when we can have a "generally recognized as ineffective" drug readily available on store shelves?

And if you happen to prefer pseudoephedrine, you'll need to ask for it from a pharmacist, which is apparently a fate worse than the common cold.