Halt use of placebo as a substitute for decongestant

THE ISSUE A substitute for an element in decongestants that is used in manufacturing methamphetamine has been found in studies to be ineffective.

NEW state and federal laws ordered popular nonprescription decongestants with pseudoephedrine, an ingredient used in making methamphetamine, to be sold from behind drugstore counters. Pharmaceutical companies responded with substitutes for pseudoephedrine. Questions now are being raised about whether those substitutes are useless. Consumers need to be aware, and the Food and Drug Administration should not allow marketing to trumpet the effectiveness of an ineffective ingredient.

Fortunately, oral decongestants containing pseudoephedrine remain available in generic form at pharmacy counters, where the consumer is obliged to provide name, address and signature and be limited in the amount purchased. For example, Longs continues to sell its inexpensive, generic version of a medicine similar to the uncompromised version of Sudafed.

Oklahoma began the ban on over-the-counter sales of medicines containing pseudoephedrine in 2004, resulting in a large drop in meth lab seizures. A Hawaii law enacted last year limited single-day and monthly purchases of pseudoephedrine medicines such as Sudafed and Benadryl. The federal law requiring over-the-counter sales took effect Sept. 30.

As the restrictions approached, drug manufacturers began replacing pseudoephedrine with other ingredients, most commonly phenylephrine. Pfizer introduced a version of Sudafed using phenylephrine, and similar substitutions have been made in Benadryl, Tylenol, Vicks and other medicines.

The drug companies should have known better. Seven of 11 studies conducted decades ago as the basis for FDA approval of over-the-counter decongestants showed phenylephrine at the allowable 10 milligram dose to be ineffective.

In a letter published last summer in the Journal of Allergy and Clinical Immunology, University of Florida research pharmacists Leslie Hendeles and Randy Hatton said the studies found that only 38 percent of the element gets into the system, compared to 90 percent of pseudoephedrine.

"At the maximum 10 milligram dose, phenylephrine is no more effective than a placebo," Hendeles told Newhouse News Service. "It's like shooting blanks." She said there is some evidence that a 25 mg dose of phenylephrine could be effective.

The FDA has rejected pleas by Rep. Henry Waxman, D-Calif., a longtime pharmaceutical industry watchdog, to convene an expert advisory committee to review all the available information on the substitute element because of concerns about its ineffectiveness.

The agency merely referred to a 1976 decision approving the use of phenylephrine. That response is unacceptable because of findings from studies conducted since then. A new study cited by Waxman found that phenylephrine is "not significantly different from placebo in decreasing nasal congestion," while pseudoephedrine is "significantly more effective."