OxyContin - Narcotic Maker Guilty of Deceit Over Marketing

[Guest guest]

Same lies about vaccines - they don't just lie about other drugs

The $600 Million fine is a fraction of what they earned, to say

nothing of the lives affected by their " misbranding. "

_________

May 11, 2007

Narcotic Maker Guilty of Deceit Over Marketing

By BARRY MEIER

(http://topics.nytimes.com/top/reference/timestopics/people/m/barry_me

ier/index.html?inline=nyt-per)

ABINGDON, Va., May 10 — The company that makes the painkiller

OxyContin and three of its current and former executives pleaded

guilty Thursday in federal court here to criminal charges that it had

misled doctors and patients when it claimed the drug was less likely

to be abused than traditional narcotics.

The company, Purdue Pharma, agreed to pay $600 million in fines and

other payments to resolve the criminal charge of " misbranding " the

product, one of the largest amounts ever paid by a drug company in

such a case.

The three executives, including its president and its top lawyer,

also pleaded guilty to misdemeanor charges of misbranding the drug.

Together, they agreed to pay $34.5 million in fines.

The guilty plea — by Purdue Frederick, an affiliate of Purdue Pharma —

is the latest of a number of cases brought by the Justice Department

against pharmaceutical makers that accuse them of misbranding, a

broad statute that makes it a crime to put false or misleading

information about a drug on its label or in ads, or to promote it for

unapproved use.

Another company, Bristol-Myers Squibb, pleaded guilty Thursday to

making false statements to the government involving its anti-clotting

medicine Plavix. [Page C3.]

The Purdue plea underscores the growing pressure on the drug industry

over its marketing. On Wednesday, the Senate passed a bill to give

the Food and Drug Administration power to oversee drug advertising

and labels, and to restrict the distribution of risky medicines.

OxyContin is a powerful, long-acting narcotic that provides relief of

serious pain for up to 12 hours. Initially, Purdue Pharma contended

that OxyContin, because of its time-release formulation, posed a

lower threat of abuse and addiction to patients than traditional,

faster-acting painkillers like Percocet or Vicodin.

That claim became the linchpin of an aggressive marketing campaign

that helped the company sell over $1 billion worth of OxyContin a

year.

Purdue Pharma, based in Stamford, Conn., heavily promoted OxyContin

to doctors like general practitioners, who often had little training

in treating serious pain or in recognizing signs of drug abuse.

But experienced drug abusers and novices, including teenagers, soon

discovered that chewing an OxyContin tablet — or crushing one and

then snorting the powder, or injecting it with a needle — produced a

high as powerful as heroin. OxyContin is a pure, high-strength

version of a long-used narcotic, oxycodone.

By 2000, parts of the United States, particularly rural areas, began

to see soaring rates of addiction and crime related to use of the

drug.

At a news conference Thursday in Roanoke, Va., L. Brownlee, the

United States attorney for the Western District of Virginia, said the

impact of Purdue's marketing of OxyContin had resulted in rising

crime rates, teenage drug addiction, deaths and other problems.

" The results of Purdue's crimes were staggering, " he said.

In a statement, the company said the three executives were not aware

of the wrongdoing by other company employees. Misdemeanor charges

of " misbranding " can be brought against corporate executives even if

they are unaware of such crimes.

The three men — Friedman, the president; R. Udell, its

top lawyer; and Dr. D. Goldenheim, its former medical director —

led Purdue at the time of the crimes.

The developments marked a sharp reversal for Purdue Pharma, a

privately held company. Its executives had defeated hundreds of

lawsuits from patients claiming that they became addicted to

OxyContin. They also rebuffed critics, including some in Congress,

who said that the company's aggressive marketing of OxyContin may

have spurred its abuse.

The company's defenders included the former New York mayor, Rudolph

W. Giuliani, whose firm was hired in 2002 by Purdue Pharma as part of

a crisis management strategy and to improve security at its

manufacturing plant.

More recently, Mr. Giuliani, acting as a lawyer for Purdue, took part

in several meetings last year between Justice Department officials

and defense lawyers for the company and individual executives.

Hillis, a spokeswoman for the Bracewell & Giuliani law firm,

which is based in Houston, said that Purdue Pharma was a client of

the firm. She said Mr. Giuliani had not been involved in representing

the company for several months.

The company and the three executives pleaded guilty at a small

courthouse in this small city at the edge of Appalachia, a region

where OxyContin abuse became so widespread that the drug was

dubbed " hillbilly heroin. " Mr. Brownlee and other prosecutors decided

to investigate Purdue Pharma after bringing cases against drug

addicts as well as local doctors accused of illegally prescribing the

drug.

" I think we had a responsibility to bring cases against everyone who

was making money, " Mr. Brownlee said.

The crimes to which the company and its executives pleaded guilty

took place between late 1995, when the federal Food and Drug

Administration approved OxyContin for sale, and mid-2001, when Purdue

Pharma, facing public criticism and regulatory scrutiny, dropped

all " reduced-risk " claims related to the drug.

During that period, OxyContin produced $2.8 billion in revenue for

Purdue Pharma.

Federal officials said that internal Purdue Pharma documents showed

that company officers recognized that, even before the drug was

marketed, they would face stiff resistance from doctors concerned

about the potential of a narcotic like OxyContin to be abused by

patients.

As a result, prosecutors charged, the company effectively started a

fraudulent and deceptive marketing campaign aimed at convincing

doctors that OxyContin, because of its time-release formula, was less

prone to abuse, and that it was less likely to cause addiction or to

produce other narcotic side effects than competing drugs. In its plea

agreement, the company acknowledged doing so.

" We accept responsibility for those past misstatements and regret

they were made, " the company said.

According to prosecutors, some Purdue Pharma supervisors and

employees used fraudulent techniques to promote OxyContin to doctors.

For instance, when the painkiller was first approved, F.D.A.

officials allowed Purdue Pharma to state the time-released nature of

a narcotic like OxyContin " is believed to reduce " its potential to be

abused.

But some Purdue sales representatives falsely told doctors that the

statement meant that OxyContin was less likely to lead to addiction

or abuse than traditional, fast-acting painkillers like Percocet.

In addition, some company sales officials gave doctors misleading

scientific charts to support such fraudulent claims. Also, Purdue

Pharma trained its sales representatives on how to overcome concerns

by doctors that OxyContin could be easily abused, according to the

transcript of a training tape made for Purdue Pharma sales official

that was released by Mr. Brownlee.

Purdue Pharma also knew, prosecutors charged, that large quantities

of oxycodone could be easily extracted from OxyContin so the drug

could be intravenously injected by drug addicts.

Of the $600 million in payments, Purdue Frederick will pay $470

million in fines and payments to a variety of federal and state

agencies.

It also agreed to pay at least $130 million to resolve civil lawsuits

brought by pain patients who claimed they became addicted as a result

of having OxyContin prescribed to them. A lawyer for one company

executive said that much, if not all, those funds have been paid out

in the process of settling lawsuits. There are still claims against

the company by private plaintiffs.

This week, Purdue agreed to pay $19.5 million to 26 states and the

District of Columbia to settle complaints that it encouraged

physicians to overprescribe OxyContin.

Some drug industry critics said Thursday that while the fines sent an

important message, the amounts were far too low, given the vast

profits from OxyContin sales and the problems caused by the drug.

" The damage to the public from these white-collared drug pushers

surely exceeds the collective damage done by traditional street drug

pushers, " Dr. Sidney Wolfe, the director of the health research group

at Public Citizen, an advocacy group in Washington, said.

Mr. Friedman, Purdue's president, agreed to pay $19 million in fines;

Mr. Udell, its lawyer, $8 million; and Dr. Goldenheim, $7.5 million.

A Purdue Pharma spokesman said that Mr. Friedman planned to leave the

company this year but that his departure was not related to his

guilty plea.

___________________

In Guilty Plea, OxyContin Maker to Pay $600 Million

http://www.nytimes.com/2007/05/11/business/11drug-web.html?n=Top%

2fReference%2fTimes%20Topics%2fPeople%2fM%2fMeier%2c%20Barry

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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