It becomes easier to sell ineffective medicines
The response of pharmaceutical companies was to rush the development of the only remaining drug that could be freely sold on the shelves. “(Phenylephrine) probably took him from one product to 261 products,” Handeres said. “Pharmaceutical companies wanted to sell this drug in airports, cruise ships, and convenience stores, so they would have lost a lot of sales if they hadn’t made the switch.”
Since then, sales of ineffective but easy-to-buy nasal decongestants have dwarfed sales of effective but difficult-to-buy drugs.
But how did an ineffective drug get approved by the FDA? Like dozens of other drugs on pharmacy shelves, phenylephrine-based nasal decongestants have been tested by the government for their effectiveness. It dates back to the days when they required evidence of safety. It wasn’t until 1962 that a law was passed requiring drugs to be tested for effectiveness.
At the time, the FDA sought to organize the hundreds of drugs already on shelves by grouping products into categories and using expert panels to grant approval to those categories. Phenylephrine has been combined with effective nasal decongestants.
When Hendeles and colleague Randy Hutton examined the studies the FDA used to make its decisions, they found some of the studies were flawed. Additionally, Hutton said some of the better studies are terrible.
In randomized controlled trials, some volunteers were exposed to allergens for many hours. Although they reported symptom relief with older Sudafed, the phenylephrine drug did not have decongestant effects comparable to placebo.
Some over-the-counter medications may be slightly effective without clearing the sinuses. For example, some allergy medications contain antihistamines in addition to phenylephrine, which can help relieve watery and itchy eyes. Some cold and flu medicines also contain acetaminophen (Tylenol), which can reduce pain and fever and help you feel better.