MANY COLD MEDS AREN'T WHAT THEY USED TO BE

Drug makers have reformulated some brands to comply with meth laws,
but critics say the new mixes are worthless.

WASHINGTON - Nose stuffed up? Grabbing a decongestant from the
drugstore or supermarket shelf may not provide the relief it did just
weeks ago.

Makers of dozens of nonprescription oral nasal decongestants sold
under familiar brand names such as Dimetapp, Sudafed, Tylenol, Vicks,
Benadryl and Triaminic recently changed an active ingredient in some
of their products to avoid a new federal mandate that the meds be
sold behind the counter.

Now a number of pharmaceutical experts and one influential member of
Congress are questioning whether replacing pseudoephedrine -- which
is subject to sales restrictions -- with the ingredient phenylephrine
has made many of the over-the-counter remedies largely useless in
clearing up nasal congestion.

"At the maximum 10 milligram dose, phenylephrine is no more effective
than a placebo. It's like shooting blanks," said Leslie Hendeles, a
research pharmacist at the University of Florida.

John Colazzi, dean of Rutgers University's Ernest Mario School of
Pharmacy, said phenylephrine had not been widely used for years
because of its "limited effectiveness."The impression I have is that
phenylephrine isn't that good of a nasal decongestant, and not as
effective as pseudoephedrine," Colazzi said.

Drugmakers began switching to phenylephrine as an active ingredient
for some of their nonprescription decongestants and allergy medicines
because of the Combat Methamphetamine Act, which was signed into law
in March by President Bush and went into effect on Sept. 30.

Under that law, any medicines that can be used in the illegal
production of methamphetamine, including pseudoephedrine, have to be
kept behind store counters, with customers showing an ID, signing a
log book and facing a limit on how much they can purchase.

Phenylephrine was the only alternative for drugmakers wanting to keep
their products on open store shelves; a third ingredient,
phenylpropanolamine, or PPA, was voluntarily withdrawn in 2000
because strokes were associated with its use.

Rep. Henry Waxman, D-Calif., a longtime pharmaceutical industry
watchdog, has twice asked the FDA to convene an expert advisory
committee to review all the available data on phenylephrine because
of the concerns about its effectiveness, but his pleas have been rejected.

Waxman recently renewed his request to the FDA, citing a newly
completed small clinical trial conducted by drugmaker Schering-Plough.

That study of 38 subjects compared phenylephrine with a placebo and
pseudoephedrine. It found phenylephrine was "not significantly
different from placebo in decreasing nasal congestion" while
pseudoephedrine was "significantly more effective."

Schering spokeswoman Julie Lux said the company decided not to
reformulate its popular Claritin-D allergy product after reviewing
its clinical study and because of "the strong clinical data on the
proven long-lasting effectiveness of our key ingredient pseudoephedrine."

Waxman said Schering-Plough's decision not to switch ingredients and
to keep Claritin-D behind the counter could mean a loss of market share.

Many drugmakers have chosen a dual route -- keeping their established
name-brand products with pseudoephedrine on the market and available
behind the counter, while offering a second reformulated version
containing phenylephrine that can be displayed on open store shelves.

Suman Wason of the Wyeth consumer health medical affairs group said
his company has chosen the two-track approach with its Dimetapp and
Robitussin cold remedies.

Michael Beckerich of McNeil Consumer Health Care, a subsidiary of
Johnson & Johnson, said his company will take the same approach with
its Tylenol brand decongestant and allergy medicines.