Pubdate: Wed, 19 Nov 2003
Source: Charlotte Sun Herald (FL)
Contact  
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Copyright: 2003 Sun Coast Media Group Inc.
Author: Doris Bloodsworth
Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone)

PAINKILLER INGREDIENT LINKED TO MORE FLORIDA DEATHS THAN HEROIN

ORLANDO, Fla. - Sylvia Cover remembers her husband telling the physician, 
"Just fix me up, Doc, so I can get back to work and take care of my family."

Six months later, Gerry Cover was dead.

Hooked on a powerful painkiller called OxyContin, the 39-year-old handyman 
and father of three died from an accidental overdose. The drug had been 
prescribed by his doctor for pain from a mild herniated disc.

The Kissimmee, Fla., man's death in September 2000 was an individual 
family's tragedy. But a nine-month investigation by the Orlando Sentinel 
found a broader, more disturbing pattern: During 2001 and 2002, more than 
200 deaths statewide have been linked to the highly potent painkiller that 
has been criticized as being aggressively marketed and eagerly prescribed 
with only routine oversight from government regulators.

OxyContin, made by Purdue Pharma of Stamford, Conn., is a 12-hour 
time-release drug with the same potential for abuse and addiction as morphine.

The active ingredient in OxyContin and dozens of other strong painkillers 
is oxycodone, which comes from the opium poppy. The drug is so powerful it 
is sometimes called "heroin in a pill" and most recently has been linked to 
a prescription-drug investigation involving conservative commentator Rush 
Limbaugh.

The Sentinel's investigation tracked how three key forces - Purdue's strong 
marketing campaign, the government's lax controls and a medical community 
unschooled in OxyContin's true power - have contributed to a wave of 
addiction and death.

In turn, illegal use of the medicine has grown as more patients have become 
dependent on the drug and a new black market has emerged.

Jim McDonough, head of the governor's Office of Drug Policy, said he found 
the results troubling in light of unreleased reports that show oxycodone 
overdoses in Florida for the first half of this year continue to rise. He 
plans to respond with a number of legislative and educational proposals to 
counter what he called "overwhelming salesmanship to expound on the 
benefits of these drugs without enough cautions."

"There always was that suspicion when you did have data surrounding the 
death scene that the predominant drug that seemed to be there was 
OxyContin," McDonough said.

"If this was a rash of crimes resulting in death ... we wouldn't stand for it."

The U.S. Food and Drug Administration, which approved OxyContin in 1995 and 
which has come under fire for failing to respond adequately to safety 
concerns about the drug, turned down repeated requests to comment on the 
Sentinel's findings.

Purdue denies its marketing ever put the public's safety at risk.

"Allegations that Purdue's marketing contributed to diversion and abuse are 
simply not true," said company spokesman Jim Heins, referring to the 
rerouting of drugs from medical to illegal use. "No evidence has been found 
to support these allegations."

Purdue executives, battling hundreds of lawsuits and several investigations 
throughout the country, blame bad publicity on a few criminal doctors and 
drug abusers who used their pain medication illegally.

In fact, the company says, there are about 2 million patients nationwide 
being helped by the painkiller. Purdue says no one has ever become addicted 
to OxyContin when taking it as prescribed.

The Sentinel's investigation, however, found evidence that dozens of 
oxycodone overdoses in Florida involved patients such as Gerry Cover.

The newspaper launched its inquiry after the Florida Attorney General's 
Office ended a tobacco-industry-style investigation last year of Purdue's 
marketing practices.

The yearlong investigation ended Nov. 1, 2002, when Florida Attorney 
General Bob Butterworth signed an agreement promising never to sue Purdue 
for any actions up to that point. Purdue pledged $2 million toward a 
prescription-tracking program that has failed to gain legislative approval.

Butterworth and one of his assistants who helped in the probe, Dave 
Aronberg, acknowledged that their enthusiasm was dampened by calls from 
pain patients who feared the drug might be pulled from the market and by an 
online poll that showed little support for a lawsuit.

In its research, the newspaper examined 500 autopsy reports from across 
Florida, reviewed more than 5,000 pages from the state's inquiry and 
interviewed scores of health-care professionals, law-enforcement officers, 
OxyContin patients, addicts and drug-rehabilitation experts.

the number of patients making office visits, and hence profits. But 
law-enforcement officials say it takes only a few bad doctors to create 
large pockets of addicts.

A number of Florida doctors who were among Purdue's top subscribers found 
themselves behind bars. A Panhandle doctor became the first in the country 
to be convicted of manslaughter by overprescribing OxyContin. Other doctors 
in Florida have been charged with murder or drug trafficking.

Dr. Sarfraz Mirza, who ran the We Really Care Clinic in Melbourne, was 
arrested July 29 on 11 counts of trafficking OxyContin. Investigators said 
they are looking into the possibility that up to eight patients may have 
died from overdoses.

The Sentinel study showing OxyContin identified in more than 200 deaths in 
Florida during a two-year period comes at a time of intensifying 
controversy about Purdue's "wonder drug." Reports of deaths blamed on 
OxyContin extend from Key West to Seattle, and hundreds of consumers have 
sued the company.

The most recent shot came from someone formerly inside the company.

In July, one of Purdue's former top researchers, Marek Zakrzewski, sued the 
company, alleging it had tried to cover up defects in OxyContin that may 
have led to addiction and fatal overdoses. Zakrzewski said he was fired in 
May 2003, a month after he went to the FDA to report his concerns.

Zakrzewski, who had been hired as an assistant director in July 2000, 
stated in court records that he discovered inconsistencies in OxyContin 
that caused some tablets to dissolve more quickly than others.

"The faster form could potentially dissolve more quickly into the human 
body than expected and cause overdosing and potentially lead to addiction," 
he stated in the lawsuit.

Zakrzewski said company officials told him not to share his concerns about 
OxyContin because Purdue "did not want problems with" the FDA. In an 
amended complaint filed Oct. 7, he named 17 Purdue officials who were told 
about irregularities, including the allegation that some OxyContin was 
unstable "when exposed to increased humidity or the passage of time."

The lawsuit mentions other concerns, including inaccurate testing methods, 
refusal to adhere to FDA specifications and problems with alcohol used in 
making OxyContin. The alcohol, critical to controlling the release rate of 
the drug, was previously the subject of a warning letter to Purdue from the 
FDA. As a result of the November 2001 letter, Purdue pulled 388 lots of the 
tablet from the market.

In interviews, Purdue officials called Zakrzewski's claims "absolutely 
without merit" and said the company expects to show they are baseless "if 
and when this case goes to trial."

Gerry Cover, the Osceola County man who sought relief for an aching back, 
never intended to become an addict.

In March 2000, Cover and his wife went to a new doctor in Celebration, Fla. 
For the first month, Sylvia Cover said, the doctor prescribed codeine, a 
narcotic her husband had tolerated well in the past. On the second visit, 
she said, the physician prescribed 40-milligram OxyContin tablets twice a 
day. Cover said the doctor reassured them OxyContin was safe.

Within days, Gerry Cover became a changed man, his family said. The 
self-employed construction manager, who rarely took a day off, began 
spending most of his time in bed. He complained that he could not last the 
full 12 hours before taking another pill. So he ran out before the end of 
the month.

Sylvia Cover said her husband became disoriented and confused, forgetting 
conversations and dates. He was obsessed with counting pills. He made sure 
his OxyContin was always close at hand, fearing the horrendous withdrawal 
symptoms that might kick in otherwise.

On Sept. 19, 2000, it looked as though the Covers' lives were turning around.

Gerry Cover had been seeing a pain-management specialist who was helping 
him reduce his medication to 20-milligram doses. Just what happened that 
night might never be fully known. Sylvia Cover and her son Gerry Jr., 18, 
were watching television while Gerry Sr. was napping. Sylvia checked on her 
husband and heard him snoring.

When she returned a little later, she found him blue and cold. An autopsy 
determined that he had a lethal dose of oxycodone.

Cover's death left his wife and children emotionally and financially 
devastated, and they are suing Purdue Pharma. Foreclosure of their modest 
home hangs over their heads.

Last Christmas, Cover made a homemade card for her son. Inside was an IOU 
until the day comes she can afford to buy a present.

"Our house used to always be full of family and friends," Sylvia Cover 
said. "We even had a party for Groundhog Day.

"But I no longer have a life."
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MAP posted-by: Beth Wehrman