Two scientists who took down America's favorite cold meds: Florida pair have ... trends now
When the FDA announced last month that the main ingredient in the country's favorite cold and flu meds didn't work, it was 'vindication' for the two scientists who dedicated nearly two decades to proving it was a dud.
Randy Hatton and Leslie Hendeles have been warning since the 1990s that phenylephrine - found in Sudafed PE or Dayquil Cold and Flu - was as ineffective as a placebo pill that when ingested did not enter the bloodstream to go to the nose.
Dr Hendeles, an expert in pharmacokinetics, or the way medicines move throughout the body, was the first to critique phenylephrine in 1993 in a study that compared the efficacy of that and other more cold remedies including pseudoephedrine, the main ingredient of Sudafed.
But for all their findings pointing to its inefficacy since that first 1993 report, the FDA and consumer groups continued to brush off their concerns, insisting that the ingredient was worth keeping on store shelves.
This also kept drug manufacturers happy, given that the phenylephrine medicine industry reaped nearly $2 billion in profits last year.
Dr Leslie Hendeles [shown left] and Dr Randy Hatton [right] pressured the FDA to take action on ineffective phenylephrine for nearly two decades before the agency agreed last month that the ingredient was no better than a placebo
The FDA panel's unanimous vote agreeing that phenylephrine is ineffective is not binding but strongly suggests the agency could soon heed their advice and pull its approval, forcing companies to pull or reformulate their products
Picture this: you wake up one morning with miserable congestion and a dry cough, and make your way to the nearest CVS or Walgreens to pick up a trusty pack of Sudafed PE or Dayquil Cold and Flu.
In 21st-century America, when it comes to cold medicines, there is an overabundance of options to choose from. Unfortunately for the average adult who gets two or three colds a year, the majority of those options are no better than a placebo.
University of Florida pharmacy researchers Randy Hatton and Leslie Hendeles have been blowing the whistle on the ineffective ingredient in many over-the-counter decongestants called phenylephrine for nearly two decades.
Numerous studies, an expansive analysis of the evidence, and a petition calling for the products’ removal later, the UF researchers finally received a win when the Food and Drug Administration formally acknowledged last month that the ingredient that has been on store shelves since the 1930s ‘is not effective’ at standard or even high doses.
The FDA’s announcement that its advisory committee had concluded phenylephrine was ineffective as an oral decongestant (the nasal sprays are still considered highly effective) caught millions of Americans by surprise.
That included Hatton and Hendeles.
Dr Hatton told the Wall Street Journal: ‘We felt vindicated for something that we've been working on for nearly 20 years that the FDA staffers and the advisory committee voted unanimously of what we had been saying for quite a long time. So that's quite rewarding.’
CVS has decided to pull certain cough and cold medicines whose main ingredient is phenylephrine.
Dr Hendeles said: 'That was exhilarating for me to hear that.'
But other major chains such as Walgreens and RiteAid have told DailyMail.com that they will only pull products from shelves if the FDA