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Drug Companies Start Reformulating Cold Medicines

Posted on: Monday, 4 July 2005, 18:00 CDT

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.

Source: Advocate; Baton Rouge, La.

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