DEA MAY TIGHTEN ACCESS TO PAIN DRUG

Hydrocodone Abuse Is at Alarming Levels

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

Literally the opioid of the masses, medications 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. It would also
prohibit doctors from phoning in prescriptions to pharmacies, and
require patients to see their doctors every time they need a refill.

Legitimate Use Stigmatized

"It's a horrible thought," said Salvatore Serra, 24, an 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," Serra 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 doctor 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."

Fisher added, "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."

Feds Are Watching

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," Cowan said.
"Do they really want to risk all the work they did to become a
physician and develop a practice because the Drug Enforcement
Administration is watching how many prescriptions they write?"

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 hydrocodone drugs -- Mallinckrodt of St. Louis and
Watson Pharmaceuticals of Corona, Calif. -- 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. In the early
1980s, Knoll began aggressively marketing Vicodin, which combines 5 to
10 milligrams of hydrocodone with up to 750 milligrams of
acetaminophen.

Growing Vicodin Abuse

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

Still, Bryan said, Abbott "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 Drug Enforcement Administration has become increasingly concerned
about the growing abuse of the drug in recent years.

At a news conference earlier this month, DEA Administrator Karen Tandy
pointed to 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 newspaper in Newark, N.J., reported that
it 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.

Review in Early Stages

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 percent 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.