FEDS NEED MORE DETAILS TO ADDRESS OXYCONTIN ABUSE

Until More Data Is Gathered, It Cannot Be Known If Heavy Marketing Is
Linked To High Abuse Rates.

At the request of federal lawmakers, the U.S. General Accounting Office
last year set out to discover whether an aggressive marketing campaign by
the makers of OxyContin contributed to a high rate of abuse and fatal
overdoses of the powerful prescription pain killer. In a report issued
Thursday, the GAO noted that sales of the drug grew rapidly as Purdue
Pharma doubled its sales force after introducing OxyContin in 1996.
However, the GAO, which is the investigative arm of Congress, said the
right data does not exist to determine whether the marketing efforts should
share blame for any abuse or deaths.

"We are not saying we find no relationship," said Marcia Crosse, author of
the GAO's report. "The data is not there."

To make that determination, GAO investigators needed to know what kind of
abuse was taking place at the county level, Crosse said. Researchers needed
to know whether a drug death was brought on by OxyContin alone - and not
another prescription that contains oxycodone, the opioid that numbs the pain.

"We could find out what the sales were," Crosse said. "But, we couldn't
find out what the abuse was."

After studying Purdue Pharma's marketing practices for a little more than a
year, the GAO did find that by 2003, nearly half of all OxyContin
prescribers were primary care physicians. That fact caused the U.S. Drug
Enforcement Administration concern because primary care physicians may not
have been adequately trained in pain management.

After OxyContin came onto the market, the company doubled its sales force
from 300-plus representatives in 1996 to 700 representatives in 2000,
according to the study. That allowed the company to increase the number of
doctors to whom it was promoting OxyContin from about 33,400 to 44,500 in
1996 to 70,500 to 94,000 in 2000. The company's salespeople also were
rewarded well for their efforts.

"As OxyContin's sales increased, Purdue's growth-based portion of the bonus
formula increased the OxyContin sales quotas necessary to earn the same
base sales bonus amounts," the report states.

"In 2001," according to the report, "the average annual salary for a Purdue
sales representative was $55,000 and the average bonus was $71,500."

U.S. Rep. James C. Greenwood, R-Bucks County, who requested the report,
said lawmakers pushed the company to end the practice of tying financial
rewards to sales volumes.

However, the practice of promoting OxyContin to primary care physicians
continues.

"Primary care physicians are at the forefront of treating patients," said
James Heins, spokesman for the Stamford, Ct.-based company. "Primary care
physicians have to treat pain."

Part of Purdue's marketing campaign also included distributing several
branded promotional items to healthcare workers, GAO report states.

Those items included: fishing hats, stuffed toys, coffee mugs with
heat-activated messages, compact discs and pens with pullout conversion
charts that show doctors how to calculate the dosage to convert a patient
from other opioid painkillers to OxyContin.

Because such items have a low value, doctors at York Hospital are allowed
to accept those types of promotional gifts, said Barry Sparks, spokesmen
for the hospital.

The Pennsylvania Attorney General's Office took issue with Purdue Pharma's
pen and got the company to stop using it as a marketing tool in the
Keystone state.

Investigators also looked at how the company educated those doctors.
According to the report, the company conducted 40 national pain management
and speaker training conferences, usually in resort locations such as Boca
Raton, Fla., and Scottsdale, Ariz.

The conferences were used to recruit and train healthcare workers for the
company's national speaker bureau. The trained speakers were then made
available to speak about the appropriate use of opioids to their
colleagues, the report states.

The company has made efforts to inform the doctors it's marketing to about
pain and its treatment, Heins said.

"For probably 20 years or more, we've been a leader in pain education
guidelines," he said.

The conferences, despite their locations, were a part of those efforts.

"It wasn't a trip to Disneyland," Heins said. "We were more conservative
than other companies. We're trying to avoid the perception that we're
paying physicians."

The face of medicine, he said, is changing every day.

"Industry-funded medical education is important," he said.

The GAO did not recommend any changes concerning how drug manufacturers
market drugs. But it did recommend that the U.S. Food & Drug Administration
should encourage companies with new drug applications to submit plans that
contain a strategy for identifying potential problems with abuse.

The FDA did not require that of Purdue Pharma when it brought OxyContin
onto the market. But, the company has since implemented such a plan.

The company and Greenwood both agree with the GAO's risk management
recommendation.