CRACKDOWN ON DRUGS HITS CHRONIC-PAIN PATIENTS

Amid Tighter Regulation Of Painkillers, Physicians Pull Back on
Prescriptions

The government's widening crackdown on prescription-drug abuse is having an
unintended consequence: It's making it tougher for people with chronic pain
to get treatment.

In recent weeks, federal regulators have sharply dialed up their effort to
combat the black market in pain killers. The White House Office of National
Drug Control Policy this month announced a $148 million plan targeting
illegal use of prescription tranquilizers, sedatives and other drugs, with a
goal of curbing the flow of drugs such as OxyContin to abusers.

Separately, the Drug Enforcement Administration is reviewing a proposal to
reclassify hydrocodone, the most commonly prescribed pain drug in the U.S.,
in a more tightly regulated class of drugs. If the switch occurs, patients
would be unable to get refills without obtaining a new prescription from a
doctor.

State regulators are stepping up their own efforts as well. Some 20 states
already have implemented some form of prescription-monitoring plan to help
track doctors who prescribe narcotics, the DEA says. Lawmakers in at least
six more states are considering similar plans.

The problem is that many of the opium-derived prescription drugs that can
successfully treat severe chronic pain -- such as oxycodone and hydrocodone
- -- also command high premiums on the street market. Rising abuse rates, and
the media frenzy generated by celebrity addiction cases like Rush Limbaugh,
have increased pressure on regulators.

Patients with chronic pain say the government initiatives are making it
harder for them to get the painkillers they need to battle conditions such
as arthritis and cancer. The crackdown is making doctors more reluctant to
prescribe some drugs out of fear they will attract attention from
regulators.

Doctors are also getting more vigilant. One Tennessee doctor turned in a
patient he believed wasn't actually taking a prescription painkiller. The
arrest took place in the doctor's office.

The DEA has been aggressively prosecuting doctors who prescribe large
amounts of painkillers that wind up on illegal markets. The agency is trying
to reduce the number of so-called pill mills -- unscrupulous doctors who
write prescriptions for narcotics to anyone who asks. The DEA has arrested
50 doctors in the year that ended last September, for issues related to
improper prescribing, including five cases where doctors allegedly were
trading prescriptions for sexual favors, according to the DEA.

"Doctors can't be pill pushers," says Bob Williamson, deputy chief in the
office of diversion control at the DEA. "Legally, they are treated like drug
dealers."

Doctors say the prosecutions are ensnaring legitimate physicians. Advances
in the way doctors treat chronic pain during the past decade have led to
more use of opioids, in higher doses, as part of an aggressive approach in
difficult pain cases.

The trouble began when OxyContin hit the market in 1996. Most traditional
pills have just a few hours' worth of opioids, but it used a time-release
formula that jammed 12 hours' worth into one pill. That meant patients could
get consistent relief for long stretches of time -- without the roller
coaster pain-relief cycle that can be caused by drugs that wear off more
quickly.

But abusers quickly realized they could grind up the pills -- defeating the
time-release formula -- and inject or snort the powder to get a massive hit
of the drug all once. By the late '90s, OxyContin was a favorite on the
street market.

The practice of prescribing drugs such as these carries increasing legal
risks for doctors. If a patient turns around and sells the drugs, the doctor
can be held legally responsible, according to the DEA. Doctors also can be
charged if a patient abuses a drug. In 2002, a Florida doctor was convicted
of manslaughter after four patients died from OxyContin overdoses. The case
is being appealed.

The DEA doesn't necessarily need to prove a doctor operated with explicit
criminal intent to bring charges. Instead, they must demonstrate the doctor
prescribed drugs "outside the scope of legitimate medical practice." That
standard is open to a range of interpretations.

The prosecutions worry pain doctors. "I'm terrified," says Dennis Ford, a
specialist in Chattanooga, Tenn., who has drastically cut back his OxyContin
prescriptions. Instead he prescribes other drugs, such as morphine and pain
patches, that he believes are less likely to draw attention from regulators.
The drugs are just as strong as OxyContin, but the street value is lower.

Dr. Ford also makes his patients take regular urine tests to confirm they
are actually taking the drugs he prescribes. "I have to be a detective," he
says. Last year, when drug traces weren't showing up in one patient's urine,
he alerted investigators, who eventually brought charges. With Dr. Ford's
cooperation, the patient's arrest occurred in his office. "I want to appear
tough," he says.

Some doctors are deciding it just isn't worth the risk to offer opioid drugs
to patients at all. "I will not treat pain patients ever again," says Frank
Adams of Houston, Texas, a former cancer pain specialist who was indicted on
charges related to opioid prescribing in the early 1990s following a DEA
investigation. The charges were later dropped, according to his lawyer,
Henry Ackels of Dallas, Texas. Dr. Adams is now the medical director of a
brain disorder clinic in Houston.

Regulators say they are trying to take a balanced approach to protect the
public health. "I don't want legitimate patients in pain undertreated
because of fears of criminal persecution," says Karen Tandy, the DEA's
administrator.

But as the market for opioid drugs grows, so does the potential for abuse.
Last year, patients filled nearly 200 million prescriptions for analgesic
narcotics, the class of painkillers that includes most opioid drugs such as
oxycodone, (the active ingredient in OxyContin), and hydrocodone (an
ingredient in painkillers such as Vicodin and Lortab). The number of
prescriptions written for analgesics has risen about 5% a year since 2000,
according to IMS Health, a pharmaceutical consulting company.

Abuse rates are rising, too. A major 2002 report, the National Survey on
Drug Use and Health, found an estimated 6.2 million Americans had used
prescription drugs for a nonmedical purpose in the previous year. Among
teens, nearly 14% reported taking a prescription drug for a nonmedical
purpose at least once in their life.

Still, the scope of the problem is in dispute. The DEA cites figures
suggesting that prescription-drug abuse has quintupled since 1998.
Researchers involved in the survey, however, say the agency's numbers may be
inflated, because the survey methodology changed over the years. Critics say
the DEA is inflating the abuse numbers to build the sense of crisis. The DEA
says the numbers are the best data available.

The increasing use of opioid drugs during the past two decades illustrates a
fundamental shift in how doctors treat chronic pain. Until the early 1980s,
opioid drugs generally were used only inside hospitals. In the mid-1980s,
the World Health Organization began a campaign to promote aggressive
treatment of severe cancer pain. The campaign led to higher rates of opioid
prescribing.

For Meg Zilkowski, a 48-year-old nurse from Forked River, N.J., OxyContin is
the only drug that eases chronic bone pain caused by leukemia. After she
went on the drug in 1998, she was able to return to work. "My life started
again," she says.

But two years ago, her doctor cut her off, telling her he had become fearful
he may attract DEA attention. He switched her to a less controversial
morphine drug that made her feel woozy and high.

The new White House plan includes a range of initiatives. Regulators will
provide grants to states to develop monitoring programs to identify "doctor
shoppers" -- patients who travel from doctor to doctor seeking drugs. The
plan also includes funding to educate doctors and state medical regulators
about appropriate use of opioids.

Some doctors worry that fears about opioids are leading patients to rely on
drugs such as aspirin and ibuprofen that can cause gastrointestinal
problems. "We're cavalier about over-the-counter drugs," says Norman Marcus,
head of the Norman Marcus Pain Institute in New York.

Sidebar

Opioids

Drug/Maker Description Comment OxyContin/Purdue Pharma LP A slow-release
pill containing oxycodone. Offers relief of moderate to severe pain for 12
hours. Drug abusers grind up the drug and snort or inject it to get an
instant high. Potentially addictive. MS Contin/Purdue Pharma LP A
slow-release morphine pill. Offers relief of moderate to severe pain for a
12-hour period. Like OxyContin, most people who use the drug for pain don't
get addicted, but patients prone to substance abuse may be at risk.
Duragesic/Janssen A skin patch that releases the synthetic opioid
painkiller fentanyl into the skin. Can provide pain relief for 3 days. Some
doctors like to prescribe patches because they're difficult to abuse. The
patch can take 12 hours to work effectively. Vicodin/Abbott Laboratories A
pill that combines hydrocodone and acetaminophen. Taken every 4 to 6 hours.
A pain reliever similar to drugs like Lortab and Lorcet. Like all opioids
the drug may be habit forming. Percoset/Endo Contains oxycodone and
acetaminophen for treating moderate pain. Taken every six hours. Like all
opioids, may cause dizziness nausea and vomiting in some patients.