Narcotic Maker Guilty of Deceit Over Marketing

May 11, 2007
Narcotic Maker Guilty of Deceit Over Marketing
By BARRY MEIER

(http://topics.nytimes.com/top/refere...ple/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., John 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 - Michael Friedman, the president; Howard R. Udell, its
top lawyer; and Dr. Paul 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.

Melanie 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/bu...eb.html?n=Top%
2fReference%2fTimes%20Topics%2fPeople%2fM%2fMeier% 2c%20Barry

Thanks, John. It is good to know that the scuz buckets who did these crimes
are getting at least some of what they deserve.

Jeff

"Twittering One" wrote in message
ps.com...
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.

A VERY subtle linguistic difference here, between "does" and "believed
to do."

The FDA allowed and approved the "believe to" language, based on my
understanding of what I have read. The Pharm company cannot just print
up advertisements without the FDA's approval, and continue to use such
language.

The FDA is guilty here, too.

UNLESS Purdue provided fraudulent clinical data.

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.

What is a "misleading chart"? Slight visual distortion, or grossly
inaccurate X and Y data, on the charts?

A common practice in every aspect of industry-sponsored medical
education and promotion is sales training to anticipate physician
questions. Nothing wrong with that, in itself.

The question is, HOW was the FDA misled?


IMHO, they weren't, this is the norm for them to lie.
Not to mention the conflict of interest.
The love of money is the root of all evil.