FDA: Studies behind cold meds are weak

FDA: Studies behind cold meds are weak
WASHINGTON - There is limited evidence that new formulations of over-the-counter cold medications actually relieve nasal congestion, federal health officials said Monday.
The Food and Drug Administration said studies of phenylephrine, an ingredient recently added to many cold medicines, are small, poorly designed and decades-old. The agency reviewed data ahead of a meeting later this month on phenylephrine in widely used nasal decongestants, such as Pfizer's Sudafed.
Manufacturers, including Pfizer Inc., Procter & Gamble Co. and Wyeth, switched to phenylephrine after Congress enacted a law in 2006 that pseudoephedrine products be kept locked behind the counter and sold on request at pharmacies. The law is aimed at prohibiting the illegal processing of drug-store cold medications into the highly addictive stimulant methamphetamine.
FDA said seven of 14 studies of phenylephrine did not show a significant improvement in nasal airflow at the currently used dosage. FDA only requires two large, comprehensive studies to support effectiveness of a drug, however agency scientists said nearly all the phenylephrine studies were inadequate.
"The studies are small and lacking many details necessary to provide a convincing demonstration of effectiveness," the FDA said.
University of Florida Professor, Leslie Hendeles, said the findings support his view that the new formulations "aren't any better than taking nothing," and he supports upping the dosage to achieve effectiveness.
Researchers at the University of Florida had requested the government examine phenylephrine's effectiveness and said there is scant evidence they work better than a placebo at the 10-milligram dose in formulas available without a prescription.
Georgetown University Professor, Kenneth Dretchen, disagreed, saying at least five of the studies reviewed by FDA are robust and show "without question" that phenylephrine works.
Dretchen chairs Georgetown's department of pharmacology and was hired by the Consumer Healthcare Products Association to review data on the ingredient. The group's members include Procter & Gamble, Wyeth and most companies that make over-the-counter medicines.
Several studies that showed poor results for phenylephrine "were not designed to be able to pick up subtle differences," in nasal airflow, Dretchen added. He is scheduled to present CHPA's case at an FDA meeting set for Dec. 14. A panel of experts will hear presentations from regulators, industry and academia and make recommendations to FDA.
"FDA may decide through its advisory panel that it wants to run one more trial just to be sure of these results," Dretchen said. "But from my own vantage point, I'm satisfied."
Researchers from the University of Florida are expected to counter at the meeting that more research is needed to find an effective phenylephrine dose.
"What we need is a large-scale scientific study in modern times looking at different doses to determine which will actually let you breath through your nose," Hendeles said. He pointed out that most of the studies of phenylephrine were performed in the 1960s and 1970s.
His group recommends increasing the dosage available without a prescription to 25 milligrams. But FDA review documents suggest there is mixed evidence the increased dose would improve effectiveness.