Pubdate: Mon, 15 Apr 2002
Source: New York Times (NY)
Section: Health
Copyright: 2002 The New York Times Company
Author: Barry Meier
Bookmark: (Oxycontin)


The federal Drug Enforcement Administration said last week that an expanded 
review of autopsy data had suggested that the painkiller OxyContin might 
have played a role in 464 drug overdose deaths in the last two years, a 
figure sharply higher than the agency's previous estimate.

But the drug's manufacturer vigorously challenged the agency's 
interpretation of that data and an official of another federal agency, the 
Food and Drug Administration, expressed caution. The company and the F.D.A. 
said they were also reviewing autopsy reports and the Food and Drug 
Administration official said that agency's study indicated that OxyContin 
did not appear to pose a threat when used properly.

The latest Drug Enforcement Administration update, which was released on 
Friday, expands on an earlier review. Last year, the agency asked state and 
local officials to submit all medical examiner and autopsy reports from 
2000 and 2001 in which the narcotic oxycodone, the active ingredient in 
OxyContin and other painkillers, had been found during autopsies.

In October, the D.E.A. said it believed that OxyContin could have played a 
role in 282 overdose deaths. The new estimate reflects a greater number of 
reports received by the agency from medical examiners in 32 states for the 
same two years.

Citing those reports, the agency said in a statement that the "recent media 
reports of 'hundreds of deaths' attributed to OxyContin can now be 
substantiated by credible scientific evidence."

But an F.D.A. official said that agency had not reviewed the reports 
underlying the D.E.A. analysis and appeared to express caution about it. 
That official, who spoke on the condition of anonymity, said the Food and 
Drug Administration's own review of data involving OxyContin was continuing 
but so far had not produced evidence that the drug posed a threat to people 
who took it as prescribed.

"We don't believe there is cause for panic," the F.D.A. official said.

The differing agency views on OxyContin appear to reflect the different 
missions of the F.D.A., which regulates prescription drugs, and the D.E.A., 
which polices their illicit use. The quandary also illustrates the 
complications regulators face in trying to keep the drug out of the wrong 
hands while making sure that those who need it can get it.

Drug enforcement officials have said that abuse of OxyContin has grown 
faster than abuse of any prescription drug in decades. The drug's maker, 
Purdue Pharma, of Stamford, Conn., heavily promoted OxyContin as safer than 
other narcotics because its active ingredient, oxycodone, was contained in 
a time-release mechanism.

Still, abusers quickly learned that they could easily crush the pill and 
release levels of oxycodone up to 16 times higher than found in other 
drugs, like Percocet, that contain the same narcotic. Misuse of the drug 
has produced widespread addiction in some parts of the country.

In its update, the D.E.A. classified 146 death reports it received as 
"OxyContin-verified," meaning that an OxyContin tablet was found at autopsy 
or that an OxyContin tablet or prescription was found at the scene. Other 
reports of OxyContin use came from witnesses.

D.E.A. officials also contended that in those deaths OxyContin was the 
direct cause or a factor.

Another 318 deaths were described as "OxyContin-likely," meaning that the 
narcotic oxycodone was found at autopsy but that two other substances, 
aspirin or acetaminophen were not present. While those compounds are found 
in other oxycodone-based painkillers, like Percocet, OxyContin accounts for 
81 percent of such drugs that contain only oxycodone.

Executives of Purdue Pharma disputed D.E.A.'s suggestion that the drug had 
caused some deaths.

"It is wrong to conclude or imply that "OxyContin-likely" or 
"OxyContin-verified" means that OxyContin was the cause of these deaths," 
the company said.

In addition, officials of Purdue Pharma said they had first been presented 
with the drug enforcement agency's data at a meeting on Friday in 
Washington that was also attended by food and drug officials. The company 
said the drug-enforcement officials had refused to share its data with it 
or with the F.D.A.

At the meeting, the drugmaker said "Purdue physicians pointed out that the 
D.E.A. interpretation of these data suffer from serious methodological 
flaws that undermine the conclusions drawn."

Because drug overdoses typically involve multiple substances, analyzing 
OxyContin's role, if any, in each death has to be done on a case-by-case 
basis. The results of those determinations are likely to be at the heart of 
a growing number of lawsuits against Purdue Pharma and any additional 
regulatory steps involving the drug.

Robin Hogen, a Purdue Pharma spokesman, said company officials had told him 
that the D.E.A. at Friday's meeting had backed away from its position that 
OxyContin was the direct cause of some deaths.

But an agency spokeswoman said the D.E.A. stood by its statement that 
OxyContin had caused or was a factor in many deaths.
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MAP posted-by: Terry Liittschwager