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News (Media Awareness Project) - US: Medicine Merchants
Title:US: Medicine Merchants
Published On:2001-03-05
Source:New York Times (NY)
Fetched On:2008-01-26 22:30:24
MEDICINE MERCHANTS

USE OF PAINKILLER GROWS QUICKLY, ALONG WITH WIDESPREAD ABUSE

Dr. Peter Leong recalls the day when he finally snapped at a drug company
salesman pressing him to prescribe a powerful narcotic painkiller called
OxyContin.

The drug's producer, Purdue Pharma, had already failed to persuade Dr.
Leong with repeated offers of free weekend trips to Florida to discuss pain
management. But when the salesman suggested that OxyContin — which is as
potent as morphine — was safe enough to treat short-term pain, Dr. Leong
exploded.

"We threw him out of my office," said Dr. Leong, who runs a pain clinic in
Bangor, Me. He thinks OxyContin is potentially too dangerous to use for
anything but chronic, severe pain. "OxyContin is a good drug," he said.
"But the problem was, they were pushing it for everything."

If Dr. Leong was not a convert, many others were. In a little over four
years, OxyContin's sales have hit $1 billion, more than even Viagra's.
Although the drug has helped thousands of people in pain, its success has
come at a considerable cost. An official of the Drug Enforcement
Administration said no other prescription drug in the last 20 years had
been illegally abused by so many people so soon after it appeared.

OxyContin has been a factor in the deaths of at least 120 people, and
medical examiners are still counting, according to interviews with law
enforcement officials. And doctors like Dr. Leong, pharmacists and law
enforcement officials say part of the problem is that Purdue Pharma often
oversold OxyContin's benefits without adequately warning of its potential
for abuse.

The company also used an often criticized but increasingly common marketing
strategy: currying the favor of doctors in private practice with free trips
and paid speaking engagements. Purdue Pharma, based in Norwalk, Conn., paid
the transportation and hotel costs for hundreds of doctors to attend
weekend meetings in spots like Florida to discuss pain management, a
company consultant said. Doctors were then recruited and paid fees to speak
to other doctors at some of the 7,000 "pain management" seminars that
Purdue sponsored around the country. Those meetings stressed the importance
of aggressively treating pain with potent, long-acting painkillers like
OxyContin.

Purdue also contributed to foundations supporting research on pain, to
pharmacy schools and to Internet sites aimed at educating consumers.

As OxyContin's marketing message spread, the drug caught on with many
doctors who medical experts said had little experience in prescribing
powerful narcotics. As a result, they often could not spot those who
intended to abuse the drug or who did not need it in the first place.

OxyContin, introduced in December 1995, has offered patients something
different: a tablet that slowly releases its powerful pain medication,
permitting patients, for example, to sleep through the night. "It's a good
drug in the right situation," said Dr. Art VanZee, a physician in St.
Charles, Va.

Purdue officials say they have promoted the drug responsibly and would have
disciplined any sales representative who did not. They also said that in
informing doctors about the drug, they told them how to spot potential drug
abusers, and they have responded quickly to reports of spreading problems.

"We don't have strong medicines that don't have abuse potential," said Dr.
J. David Haddox, the company's senior vice president for health policy.
"What we have to do is walk the balance between helping the greater good,
knowing there are always some people who will divert drugs."

Abuse and addiction involving OxyContin have spread quickly in the last two
years, flaring up in at least a dozen states. And while the illegal use of
OxyContin took root in rural areas along the East Coast, it has begun
moving into cities like Philadelphia. "Nobody is immune from this," said
Brantley Bishop, a narcotics investigator in Alabama. "I'm seeing
housewives; I'm seeing loggers, nurses, mechanics."

OxyContin was originally thought to be less prone to abuse because its
narcotic was locked in a time-release formula. That meant it would not
produce the quick spike of euphoria that drug abusers crave. But abusers
quickly discovered how to disarm the time-release formula; they simply
crushed the tablet, then swallowed, inhaled or injected the powder to give
themselves a high as powerful as heroin's.

Getting OxyContin was often easy. A person simply had to find the right
doctor, claim great pain and get a prescription. Others just stole
prescription pads and wrote their own.

Illegal use of OxyContin mushroomed even though no drug in this country is
more tightly regulated. Unlike illegal drugs like cocaine or heroin,
OxyContin is monitored by state and federal health officials in its
production, marketing and distribution. Now, many of those regulators are
trying to figure out how the outbreak occurred and what they might have
done to prevent it.

The Food and Drug Administration, for one, is reassessing how it reviews
prescription narcotics for potential abuse. "We've learned something from
this," said Dr. Cynthia McCormick, director of the F.D.A.'s division of
anesthetics, critical care and addiction drug products. Dr. McCormick
acknowledged that the F.D.A. had failed to research all the ways abusers
might tamper with OxyContin, an oversight she said her agency did not want
to repeat.

Last Thursday, officials of five states met in Richmond, Va., to discuss
ways to halt illegal traffic in OxyContin. In recent months, Purdue has
also stepped up its efforts to halt the drug's abuse, including working
with law enforcement officials.

Selling a `Miracle' Drug

OxyContin came to market amid a sea change in how doctors treated pain. For
years, terminally ill patients suffered needlessly because doctors resisted
prescribing frequent, potent doses of narcotics, fearing that patients
might become addicted.

But with new studies showing that doctors undertreated pain, OxyContin
provided a breakthrough opportunity for Purdue Pharma. Until then, the
company's biggest drug was MS Contin, which had limited appeal, partly
because it contained morphine. OxyContin had broader appeal because it
contained a synthetic version of morphine called oxycodone, which, among
other things, carried less of a social stigma.

"If Grandma is placed on morphine it's like, `Oh, my God,' " said Dr.
Howard A. Heit, a pain specialist in Fairfax, Va., and a Purdue consultant.
"But if Grandma comes home placed on OxyContin — that was O.K."

Although other pain medicine had long contained oxycodone, OxyContin
differed in two key respects: it had a time-release formula, and it could
be delivered in larger doses because it did not contain the type of
nonprescription pain relievers that in larger quantities could cause liver
damage.

The F.D.A. approved OxyContin for those with moderate to severe pain
lasting more than a few days.

OxyContin is often prescribed for people in chronic pain, like those with
back problems or severe arthritis, as well as patients with cancer and
other painful diseases.

For Robert E. Mitchell, OxyContin proved nothing short of a wonder drug. A
victim of Guillain-Barre syndrome, a rare nerve disorder that can cause
paralysis, Mr. Mitchell said his pain had become so severe he could not
walk. But with OxyContin, he can now wear shoes and has learned to walk again.

"To me, it's like a miracle," he said.

Seeing great potential in the drug, the company hatched an ambitious
marketing plan. To reach consumers, Purdue financed an Internet site called
Partners Against Pain, where OxyContin is promoted. It also contributed to
groups like the American Pain Foundation, which championed the need for
better pain treatment.

Still, most of Purdue's marketing dollars were aimed at doctors. In recent
years, Purdue brought in 2,000 to 3,000 doctors to three-day retreats in
California, Arizona and Florida, estimated Dr. Heit, the Purdue consultant.
At those meetings, doctors were lectured about treating chronic pain, while
being recruited to serve as paid speakers at medical meetings sponsored by
Purdue.

Dr. Susan Bertrand, who treats chronic pain in Princeton, W. Va., became a
Purdue speaker. She said that for her, recent studies showing the
undertreatment of pain had been "almost a religious experience," making her
realize how poorly she and others had been trained to deal with the problem.

To help change that, she said, she gave about a dozen paid speeches
sponsored by Purdue. The company also helped her start the Appalachian Pain
Foundation, an educational group on pain management.

Purdue's marketing campaign quickly began to pay big dividends, with
OxyContin sales almost doubling every year, according to IMS Health, a firm
that tracks drug sales. OxyContin now earns more in sales than any other
narcotic. It also now accounts for 80 percent of Purdue Pharma's revenue,
according to court documents filed by Purdue in connection with a patent
dispute.

Some doctors and pharmacists said they were put off by the company's sales
tactics.

"All companies market," said Dr. Diane Meier, a pain specialist at the
Mount Sinai School of Medicine in New York. "But these people were in your
face all the time."

Others criticized the way Purdue recruited doctors. "Essentially, they
bought the doctors' prescriptions," said Steve Schondelmeyer, a professor
of pharmaceutical economics at the University of Minnesota. "It says to
consumers that every time you paid for this drug, you sent your doctor to a
nice meeting somewhere."

A Growing Concern

Purdue Pharma's critics agree that doctors must learn how to manage pain
better. But Dr. Ted Parran, an associate professor at Case Western Reserve
University School of Medicine in Cleveland, says doctors, in their rush to
find a remedy, may have been blinded to another problem: addiction.

"Pain medicine docs are on a mission," said Dr. Parran, who teaches doctors
how to use narcotics. "In the process, they tend to trivialize addiction."

In this regard, pharmacists play an important backup role for doctors. They
provide the last medical defense for preventing addictive drugs from
getting into the wrong hands. For instance, they can choose not to fill
suspect prescriptions.

Some pharmacists said they, too, found Purdue's safety claims overblown.

John Craig, a co-owner of Hancocks Drug Store in Scottsburg, Ind.,
remembers a Purdue salesman walking into his pharmacy several years ago
with reassurances that OxyContin was safer than other narcotics.

"They were going around to doctors promoting that this was the answer to
all abuse," said Mr. Craig, but he already knew that local people were
using OxyContin to get high. Since then, the abuse has become worse.

Another pharmacist, Samuel A. Okoronkwo, refused to fill an OxyContin
prescription for someone he thought might be an abuser. He said a Purdue
salesman suggested he could get into trouble for arbitrarily not filling
prescriptions. "I told him I didn't have to fill a prescription that I
didn't feel was medically necessary," he said.

Another druggist, Joseph Yates in Grundy, Va., said simply, "The problem
with this drug is the company."

Purdue did not comment when asked about such anecdotes.

Concern about Purdue's marketing practices has also reached the D.E.A. An
agency official said its investigators had recently interviewed doctors and
druggists about their dealings with Purdue.

That official said the agency was worried that Purdue was not clearly
communicating the drug's serious potential for abuse. "It may take years to
repair the damage that this drug has done," said that D.E.A. official, who
declined to be identified.

Told of the D.E.A. comment, Purdue responded with a statement that said in
part: "In 15 years of marketing narcotic analgesics, Purdue Pharma has
never been questioned by the Drug Enforcement Administration regarding our
marketing practices."

In May, however, the F.D.A. did question a company advertisement for
OxyContin, saying Purdue had improperly implied that OxyContin could be
used to treat arthritis patients without first trying milder drugs. A
company spokesman said that it disagreed with the F.D.A. but had
voluntarily withdrawn the ad.

Dr. VanZee, in St. Charles, Va., has seen the destruction the drug has
caused in the valleys and small mining towns of the southwestern part of
that state. He said he was treating OxyContin overdoses in youngsters he
had vaccinated as infants.

In the past two years, OxyContin has been a factor in the overdose deaths
of 28 people in the area, said an official of the state medical examiner's
office. It is difficult to tell the precise cause of an overdose, however,
because more than one drug is often involved and OxyContin's active
ingredient is in other drugs.

One area clinic, the Life Center of Galax, expected to treat 20 patients in
its new methadone program but must now find a way to treat 300, most of
them addicted to OxyContin, a clinic official said.

To stem this abuse, Dr. VanZee said, he met last fall with Purdue
representatives in a bid to persuade them to cut back on their marketing
and to issue a nationwide alert about the drug's hazards. The officials,
Dr. VanZee said, appeared sympathetic, but said they viewed the problem as
being limited to just a few areas of the country.

"They are either very naive about the extent of the problem," Dr. VanZee
said, "or they don't understand what it means to have 300 people in your
county addicted — the type of pain that causes in a community and in families."

Addressing the Problem

Purdue officials said they were as surprised as anyone that OxyContin could
be abused. Dr. Haddox of Purdue said he thought the time-release formula
would make the pill "less desirable to addicts."

That is not the case now. Last September, the company gathered 20
consultants to look for better ways for doctors to spot potential abusers,
said Dr. Heit, the consultant. Four months later, Purdue asked its sales
force to remind doctors that drugs like OxyContin "are common targets for
both drug abusers and drug addicts."

Purdue said it was now planning to reformulate OxyContin, making it less
appealing to abusers. The company is also helping to educate students on
the dangers of prescription drugs.

Moves like this have recently earned the company praise from some law
enforcement officials.

Some health officials think OxyContin abuse might have been more quickly
identified had more states closely tracked the prescribing patterns of
narcotics; some 17 states do that now.

Hospitals are addressing the problem in different ways. Mercy Hospital in
Portland, Me., gives OxyContin patients urine screens to verify that they
are not taking too much, or that they are obtaining the drug but not taking
it and then selling it on the street.

A Cincinnati-based hospital chain, the Health Alliance, decided last month
to limit OxyContin to just a few types of patients, like those with cancer,
after determining that another painkiller was just as effective, cheaper
and less prone to abuse.

Purdue Pharma — and some doctors — now worry that media reports on
OxyContin abuse are scaring away patients who need the drug. "The
publicity, of which you are a part, is causing patients to call us in tears
because their physicians are taking them off therapy," said Robin Hogen, a
company spokesman. "This is becoming a sad case of patients being abused by
drug abusers."
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