REFORMULATING COLD RELIEF

PORTLAND, Ore. - Under pressure from law-enforcement agencies and state
governments, drug companies have begun reformulating popular cold medicines
to prevent criminals from converting them into methamphetamine.

"This is the direction we're moving," said Elizabeth Assey, spokeswoman for
the Consumer Healthcare Products Association in Washington, D.C., a
lobbying organization for the cold medicine industry.

Pseudoephedrine, a main ingredient in a number of over-the-counter drugs
such as Sudafed and Sinutab, can be extracted by boiling down cold
medicines. Toxic chemicals are then used to turn the substance into meth.

More than a dozen states already have restricted access, either by allowing
only pharmacies to sell drugs with pseudoephedrine or making retailers sell
them from staffed counters. A May report by the Office of National Drug
Control Policy found a 50 percent drop in the number of meth labs in
Oklahoma and Oregon, two of the first states to enact such restrictions.

But law enforcement officials and others believe that reformulating the
drugs can reduce the problem even more, by helping shut down the small labs
operating nationwide.

Pfizer Inc., the manufacturer of Sudafed and other leading pseudoephedrine
products, plans by January to reformulate up to half of them with
phenylephrine.

Leiner Health Products, which supplies generic cold and allergy drugs to
retail chains such as Costco, Target, Walgreens and Wal-Mart, began
shipping new products containing phenylephrine in June.

McNeil Consumer & Specialty Pharmaceuticals, a division of Johnson &
Johnson, also is considering reformulation of a variety of its products,
along with other major manufacturers, including Wyeth and Schering-Plough.

And the world's largest producer of phenylephrine - Boehringer-Ingelheim of
Germany - says it can boost production capacity for the substitute
ingredient by enough so the entire U.S. supply of pseudoephedrine could be
replaced by 2006.

The meth problem is particularly severe in the Midwest, where rural areas
provide cover for the pungent chemical odor from meth labs. In Missouri,
law enforcement officers seized more than 2,700 meth labs last year - more
than any other state.

"It's such a drain," said Mark Woodward, spokesman for the Oklahoma Bureau
of Narcotics. He said meth abuse forces law enforcement to spend millions
of dollars on toxic cleanup, prisons and increased caseloads in courts.

But pharmaceutical companies are moving cautiously to make sure substitutes
are effective, and to await proposed federal legislation that could affect
how they reformulate some of their products, said Assey, of the Consumer
Healthcare Products Association.

"It's the first step in a long process, from an industry standpoint," she said.

The meth problem has been a growing scourge in recent years. The National
Clandestine Laboratory Seizure System, which collects data from state
police agencies, shows the reported meth lab seizures increased from 6,777
in 1999 to 10,182 in 2003.

About 12.3 million Americans ages 12 and older reported trying
methamphetamine at least once, according to the 2003 National Survey on
Drug Use and Health.

The epidemic has generated plenty of interest in phenylephrine because it's
one of the best and easiest substitutes for pseudoephedrine.

Phenylephrine differs from pseudoephedrine by a single pair of oxygen and
hydrogen atoms, a tiny but important difference that makes it virtually
impossible to transform phenylephrine into methamphetamine.

"Structurally, when just looking at the chemistry, they are very, very
similar," said Kate Farthing, an Oregon Health & Science University pharmacist.

But if cooks at illegal labs try to convert phenylephrine into
methamphetamine, they get only a useless variation, Farthing said.

Still, the cold medicine industry worries that reformulating remedies
containing a combination of pseudoephedrine and some other ingredient, such
as ibuprofen, would require U.S. Food and Drug Administration approval that
could take three to five years.

The concern is being addressed in federal legislation proposed by Sen.
Dianne Feinstein, D-Calif., and Sen. Jim Talent, R-Mo.

Under the bill, consumers would have to show a photo ID, sign a log, and be
limited to 7.5 grams - or about 250 30-milligram pills - in a 30-day
period. Computer tracking would prevent customers from exceeding the limit
at other stores.

The latest draft of the bill, sent to the Senate Judiciary Committee this
week, also would expedite FDA approval of reformulated drugs.

Scott Gerber, spokesman for Feinstein, said the proposal would ensure
consumer access to cold remedies while targeting small illegal labs run by
"people who are brewing up large batches of meth in their basements, cars,
motel rooms and making it for their personal use or selling it."