[Studies prove that popular decongestants just don’t work.]
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WHY HAS A USELESS COLD MEDICATION BEEN ALLOWED ON SHELVES FOR YEARS?
 
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Sarah Zhang
September 13, 2023
The Atlantic
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_ Studies prove that popular decongestants just don’t work. _

, Mpelletier1 / Creative Commons Attribution-Share Alike 3.0

 

You wake up with a stuffy nose, so you head to the pharmacy, where a
plethora of options awaits in the cold-and-flu aisle. Ah, how lucky
you are to live in 21st-century America. There’s Sudafed PE, which
promises “maximum-strength sinus pressure and nasal congestion
relief.” Sounds great. Or why not grab DayQuil in case other
symptoms show up, or Tylenol Cold + Flu Severe should whatever it is
get really bad? Could you have allergies instead? Good thing you can
get Benadryl Allergy Plus Congestion, too.

Unfortunately for you and me and everyone else in this country, the
decongestant in all of these pills and syrups is entirely ineffective.
The brand names might be different, but the active ingredient aimed at
congestion is the same: phenylephrine. Roughly two decades ago, oral
phenylephrine began proliferating on pharmacy shelves despite
mounting—and now damning—evidence that the drug simply does not
work.

“It has been an open secret among pharmacists,” says Randy Hatton,
a pharmacy professor at the University of Florida, who filed a citizen
petition in 2007 and again in 2015 asking the FDA to reevaluate
phenylephrine. This week, an advisory panel to the FDA voted 16–0
that the drug is ineffective orally, which could pave the way for the
agency to finally pull the drug.

If so, the impact would be huge. Phenylephrine is combined with fever
reducers, cough suppressants, or antihistamines in many popular
multidrug products such as the aforementioned DayQuil. Americans
collectively shell out $1.763 billion a year for cold and allergy meds
with phenylephrine, according to the FDA, which also calls the number
a likely underestimate. That’s a lot of money for a decongestant
that, again, does not work.

Over-the-counter oral decongestants weren’t always this bad. But in
the early 2000s
[[link removed]], states
began restricting access to pseudoephedrine—a different drug that
actually is effective against congestion—because it could be used to
make meth; the Combat Methamphetamine Epidemic Act
[[link removed]], signed in 2006,
took the restrictions national. You can still buy real-deal Sudafed
containing pseudoephedrine, but you have to show an ID and sign a
logbook. Meanwhile, manufacturers filled over-the-counter shelves with
phenylephrine replacements such as Sudafed PE. The _PE_ is for
phenylephrine, but you would be forgiven for not noticing the
different name.

“The switch from pseudoephedrine to phenylephrine was a big
mistake,” says Ronald Eccles, who ran the Common Cold Unit at
Cardiff University until his retirement. Eccles was critical of the
switch back in 2006 [[link removed]]. The
evidence, he wrote at the time, was already pointing to phenylephrine
as a lousy oral drug.

Problems started showing up quickly. Hatton, who was then a
co-director of the University of Florida Drug Information Center,
started getting a flurry of questions about phenylephrine: _Does it
work? What’s the right dose? Because my patients are complaining
that it’s not doing anything._ He decided to investigate, and he
went deep. Hatton filed a Freedom of Information Act request for the
data behind FDA’s initial evaluation of the drug in 1976. He soon
found himself searching through a banker’s box of records, looking
for studies whose raw data he and a postdoctoral resident typed up by
hand to reanalyze [[link removed]]. The 14
studies the FDA had considered at the time had mixed results. Five of
the positive ones were all conducted at the same research center,
whose results looked better than everyone else’s. Hutton’s team
thought that was suspicious. If you excluded those studies, the drug
no longer looked effective at its usual dose.

All told, the case for phenylephrine was not great, but the case
against was no slam dunk either. When Hatton and colleagues at the
University of Florida, including Leslie Hendeles, filed a citizen
petition [[link removed]],
they asked the agency to increase the maximum dose to something that
could be more effective. They did not ask to pull the drug entirely.

There was more damning evidence to come, though. The petition led to a
first FDA advisory committee meeting, in 2007, where scientists from a
pharmaceutical company named Schering-Plough, which later became
Merck, presented brand-new data. The company had begun studying the
drug, Hatton and Hendeles recalled, because it was interested in
replacing the pseudoepinephrine in its allergy drug Claritin-D. But
these industry scientists did not come to defend phenylephrine.
Instead, they dismantled the very foundation of the drug’s supposed
efficacy.

They showed that almost no phenylephrine reaches the nasal passages,
where it theoretically could reduce congestion and swelling by causing
blood vessels to constrict. When taken orally, most of it gets
destroyed in the gut; only 1 percent is active in the bloodstream.
This seemed to be borne out by what people experienced when they took
the drug—which was nothing. The scientists presented two more
[[link removed]] studies
[[link removed]] that found phenylephrine
to be no better than placebo in people congested because of pollen
allergies.

These studies, the FDA later wrote, were “remarkable,” changing
the way the agency thought about how oral phenylephrine works in the
body. But experts still weren’t ready to write the drug off
entirely. The 2007 meeting ended with the advisory committee asking
for data from higher doses.

The story for phenylephrine only got worse from there. In hopes of
making an effective product, Merck went to study higher doses in two
randomized clinical trials published in 2015
[[link removed]] and 2016
[[link removed]]. “We went double,
triple, quadruple—showed no benefit,” Eli Meltzer, an allergist
who helped conduct the trials for Merck, said at the
FDA-advisory-panel meeting this week. In other words, not only is
phenylephrine ineffective at the labeled dosage of 10 milligrams every
four hours, it is not even effective at_ four times _that dose.
These data prompted Hatton and Hendeles to file a second citizen
petition and helped prompt this week’s advisory meeting. This time,
the panel didn’t need any more data. “We’re kind of beating a
dead horse … This is a done deal as far as I’m concerned. It
doesn’t work,” one committee member, Paul Pisarik, said at the
meeting. The advisory’s 16–0 vote is not binding, though, so
it’s still up to the FDA to decide what to do about phenylephrine.

In any case, phenylephrine is not the only cold-and-flu drug with
questionable effectiveness in its approved form. The common cough
drugs guaifenesin and dextromethorphan have both come under fire
[[link removed]]. But we lack the
robust clinical-trial data to draw a definitive conclusion on those
one way or the other. “What really helped our case is the fact that
Merck funded those studies,” Hatton says. And that Merck let its
scientists publish them. Failed studies from drug companies usually
don’t see the light of day because they present few incentives for
publication. Changing the consensus on phenylephrine took an
extraordinary set of circumstances.

It also required two dogged guys who have now been at this work for
nearly two decades. “We’re just a couple of older professors from
the University of Florida trying to do what’s best for society,”
Hatton told me. When I asked whether they would be tackling other cold
medications, he demurred: “I don’t know if either one of us has
another 20 years in us.” He would instead like to see public funding
for trials like Merck’s to reevaluate other over-the-counter drugs.

There are other effective decongestants on pharmacy shelves. Even
though phenylephrine does not work in pill form, “phenylephrine is
very effective if you spray it into the nose,” Hendeles says.
Neo-Synephrine is one such phenylephrine spray. Other nasal sprays
containing other decongestants, such as Afrin, are also effective. But
the only other common oral decongestant is pseudoephedrine, which
requires that extra step of asking the pharmacist.

Restricting pseudoephedrine has not  curbed the meth epidemic,
either. Meth-related overdoses are skyrocketing
[[link removed]],
after Mexican drug rings perfected a newer, cheap way
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make methamphetamine without using pseudoephedrine at all. This
actually effective drug still remains behind the counter, while
ineffective ones fill the shelves.

_Sarah Zhang [[link removed]] is a
staff writer at The Atlantic._

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