DRUG'S PROPONENTS FIND PROPOSAL HARD TO SWALLOW

Reclassifying Pain-Reliever To Stem Abuse Would Also Make Drug More
Difficult For Patients To Get

WASHINGTON -- The federal government is considering tightening restrictions
on narcotic pain relievers containing hydrocodone, a move that would greatly
complicate the pain relief therapies of millions of Americans.

Literally the opioid of the masses, medication containing hydrocodone --
Vicodin, Lortab, Norco and many others -- were prescribed by doctors more
than 100 million times last year, more than any other prescription drug.
Opioids are synthetic forms of opiates.

Citing skyrocketing hydrocodone abuse statistics, the heads of the Drug
Enforcement Administration and the Food and Drug Administration say they are
considering moving hydrocodone compounds from Schedule III to the much more
restrictive Schedule II of the Controlled Substances Act.

The change would place the hydrocodone compounds in the same category as
their narcotic cousins morphine and OxyContin, prohibit doctors from phoning
in prescriptions to pharmacies and require patients to see their doctors
every time they need a refill.

"It's a horrible thought," said Salvatore Serra, a 24-year-old unemployed
laborer from Goodrich, Mich., who relies on Vicodin to tame the pain he has
endured since a 1998 assembly line accident.

"People are barely getting by with what little medicine they can get.
Doctors don't like to write prescriptions for narcotics. If it's schedule
II, they won't touch it," he said.

The idea of reclassifying hydrocodone compounds comes as chronic pain
sufferers grow increasingly concerned that the federal war on drugs has
stigmatized legitimate users of narcotics and made doctors afraid that
treating patients with strong drugs will land them in jail.

Frank Fisher, a California pain physician who was accused of murder in
several overdose deaths before the charges were dismissed, said doctors
already are leery about prescribing hydrocodone. Rescheduling it, he said,
"will make a terrible situation worse."

"The war on drugs has morphed into a war on legal drugs. What we're seeing
with this proposal is the furthest, most insane, extension of that
prohibition. It will harm millions of people," he said.

Penny Cowan, a spokeswoman for the American Chronic Pain Association,
agreed.

"Doctors are very uncomfortable writing Schedule II prescriptions because
they feel threatened by the federal government. Do they really want to risk
all the work they did to become a physician and develop a practice because
the DEA is watching how many prescriptions they write?" she asked.

Hydrocodone, in compounds that also contain the pain reliever acetaminophen,
has been the nation's top-selling prescription drug since 2000, outpacing
even popular noncontrolled drugs such as the cholesterol-lowering Lipitor.

According to the industry-tracking group IMS Health, the top two generic
makers of the drugs -- Mallinckrodt of St. Louis and Watson Pharmaceuticals
of Corona, Calif. -- alone accounted for 74 million prescriptions last year.

Based on the codeine molecule, hydrocodone was first manufactured in the
1920s by the German firm Knoll Laboratories as an alternative to other
opium-based pain killers and cough suppressants. Knoll began aggressively
marketing Vicodin, which combines between 5 and 10 milligrams of hydrocodone
with up to 750 milligrams of acetaminophen, in the early 1980s.

Abbott Laboratories of Abbott Park, Ill., acquired Knoll and its
Vicodin-making business from BASF in 2001. Catherine Bryan, a spokeswoman
for Abbott, said the pharmaceutical giant has seen no evidence that
rescheduling the drug will reduce its abuse potential.

Still, she said, the company "supports appropriate abuse restrictions for
potent opiates" and neither endorses nor opposes the rescheduling.

Hydrocodone without acetaminophen already is a DEA Schedule II drug, but the
compounds remain in the less stringently regulated Schedule III. The DEA has
become increasingly concerned about the growing abuse of the drug in recent
years.

At a press conference earlier this month, DEA Administrator Karen Tandy
pointed to statistics from a recent University of Michigan study that found
Vicodin second behind marijuana in illicit drug use by 12th graders, with
10.5 percent saying they had tried it.

Tandy called the figure "staggering."

Vicodin and other hydrocodone compounds also are at the center of
controversy over illegal online pharmacies, where they are among the top
sellers. The Star-Ledger was able to purchase Vicodin and other powerful
narcotics from Internet pharmacies without a prescription or any doctor
involvement as part of an investigation last fall.

The Physicians' Desk Reference urges doctors to prescribe the drug with
caution, warning that use of the hydrocodone compounds can lead to "psychic
dependence, physical dependence, tolerance" and withdrawal symptoms.

Still, Tandy and FDA Administrator Mark McClellan said the proposed
rescheduling is not aimed at limiting the legitimate uses of the drug. Tandy
said the DEA is in the early stages of reviewing the reclassification, a
process that could take years.

"I would like to correct that DEA is pushing to reschedule hydrocodone into
Schedule II. We are simply following the process, based on a referral by a
physician in the addiction community," Tandy said.

The referring physician is Ronald Dougherty, medical director of the Tully
Hill Alcohol and Drug Treatment Center near Syracuse, N.Y. He said 50 to 60
percent of addicts he treats each year are hooked on hydrocodone compounds.

"A lot of these people start out with legitimate pain, and then they get
hooked on this and start forging prescriptions, doctor shopping, stealing
the drug and so on," he said, adding that withdrawal symptoms persist much
longer than those associated with heroin.

If reclassifying hydrocodone compounds gives doctors pause before they
prescribe it, that's the whole point, Dougherty said.

"We know Big Brother is watching us if we prescribe Schedule II. Although it
may be necessary for pain, doctors need to know that authorities are
watching if they prescribe these drugs in excessive amounts," he said.