Giuliani Supports Corporate Drug Criminals!

[Guest Freedom Fighter]

Rudy's role with drug firm raises questions

BY JOHN RILEY

john.riley@newsday.com July 15, 2007

http://www.newsday.com/news/nationworld/nation/ny-usrudy0715,0,4066993.story?coll=ny-top-headlines

 

On Oct. 23, 2003, Rudy Giuliani appeared with Rep. Curt Weldon in suburban

Upper Darby, Pa., to announce a new program -- called "Dime Out a Dealer" --

that was designed to combat the growing scourge of prescription drug abuse

by offering $1,500 rewards to anyone who turned in a pusher.

 

"Congressman Weldon's new program helps us go after the real villains here,

the illegal dealer," Giuliani said, praising both Weldon (R-Pa.) and Purdue

Pharma, the Stamford, Conn., drugmaker that was underwriting the program,

according to a news release. "By doing so, we ensure that the patients who

require these same life-saving and enhancing medicines are not denied access

based upon the illegal conduct of others."

 

The appearance was one in a series of efforts Giuliani undertook over a

five-year period after leaving City Hall in 2002 -- from image-building and

security-consulting to behind-the-scenes lawyering -- that helped Purdue

grapple with the fallout from widespread abuse of its blockbuster

painkiller, OxyContin, by focusing attention on street criminals rather than

corporate misconduct and lax regulation.

 

In May, however, the company and three top executives agreed to pay a

$640-million fine and plead guilty to fraudulently marketing the drug

between 1995 and 2001 by minimizing its addictive potential. Federal

prosecutors said scores had died and many more became addicted, and with

Giuliani now running for president, the plea deal he helped negotiate has

drawn new attention from some OxyContin critics who say he provided a "smoke

screen" that deflected attention from the over-marketing and

under-regulation they blame for the crisis.

 

"The country was being devastated, continues to be devastated, and his

function was to convince the public that there wasn't a problem with the

drug," said Marianne Skolek, a New Jersey nurse whose daughter Jill died in

2002 of heart failure after she was prescribed OxyContin for a herniated

disc. " ... He is not a hero to the thousands of parents who have lost kids

or whose kids are in rehab facilities as a result of Purdue peddling this

drug."

 

"If he became president, I would like to move to Canada," said Ed Bisch,

whose teenage son died in Philadelphia in 2001 after mixing illicit

OxyContin with alcohol. "I'll do everything in my meager power to stop his

election."

 

Purdue declined to respond to these criticisms, except to say that it was

"pleased" with Giuliani's services. Giuliani declined to be interviewed, but

in the past has portrayed himself as devoted to ensuring that suffering

patients didn't lose access to valuable pain medication because of problems

of abuse and illegal trafficking. "You can't throw out the baby with the

bathwater," he said in a speech in Kansas City, Mo., last year.

 

Those views, an aide said Friday, are not the result of being retained by

Purdue. "Mr. Giuliani's opinions about pain medicines are informed and his

very own," said spokeswoman Sunny Mindel. Purdue, Giuliani's consulting firm

and his law firm all declined to specify his fees.

 

It is not clear whether the OxyContin critics will become as vocal and

visible as other Giuliani adversaries, such as New York City firefighters

who regularly spar with him over his Sept. 11 record. But with OxyContin

still a widely abused drug, and a hearing set for Friday on Purdue's plea

deal in federal court in Virginia expected to attract another round of

attention, Giuliani's work for the drug company seems to hold more political

peril than most of his private-sector activity.

 

While some political experts said he had nothing to worry about because he

wasn't involved in Purdue's lawbreaking, others said his role could be a fat

target for opponents.

 

"This is one of Giuliani's Achilles' heels," said Baruch College public

affairs professor Doug Muzzio. "He was directly and intimately involved with

a company that was in violation of law and morals and ethics. There are ways

to frame the issue that resonate, that Rudy Giuliani is sacrificing the

public weal for his own personal benefit."

 

Packed a powerful punch

 

OxyContin first hit the market in 1995 to meet a perceived need for more

effective pain relievers. An opium-based analgesic in a time-release

formulation, it packed an unusually powerful punch and was heavily marketed

by Purdue both to those who suffered from chronic and intense cancer pain

and to patients with less severe ailments.

 

It had become a huge moneymaker -- $1.3 billion in sales, $392 million in

profit in 2001 -- but also faced a Drug Enforcement Administration

investigation, calls for tighter FDA regulation, and media and congressional

scrutiny of abuse and overprescribing when Purdue hired Giuliani Partners,

the ex-mayor's newly minted consulting firm, in January 2002.

 

Part of the assignment was to help design a security plan for Purdue's

plants, to prevent thefts of OxyContin that were under a DEA microscope, and

to advise on other steps that might help stop illicit diversion. But one

Purdue official later admitted, according to published reports, that

Giuliani also was hired in part as a "political consultant" -- a

characterization Purdue now disputes. Early on, he used his clout to arrange

meetings with DEA chief Asa Hutchinson to discuss the plant security probe,

which eventually led to a $2-million civil fine for recordkeeping

violations.

 

"I felt they were not doing everything they could do. In my opinion they

hired Rudy to give them a good image, and to get around me," said Laura

Nagel, the chief DEA diversion investigator at the time. "Rudy got them

access to higher levels of government." But she says Hutchinson never

interfered.

 

The criminal conduct the firm admitted to in May involved sales efforts in

2001 and earlier -- prior to Giuliani's hiring -- to falsely convince

doctors that Oxy.Contin was less addictive than other painkillers. The

government alleges in civil filings, however, that fraudulent marketing

practices actually continued until 2005, three years after Giuliani's

hiring. Purdue did not admit to that as part of the plea bargain.

Prosecutors have declined to provide details.

 

A federal investigation began in 2003. Giuliani's role as a defense lawyer

did not become publicly known until May of this year and it is not clear

when it began, but government and defense sources have confirmed that he

played a key role last fall in negotiating the "agreement in principle" that

led to May's plea.

 

While the plea deal has sparked opposition among some OxyContin critics who

view it as too lenient, few blame Giuliani for his legal work. Instead, it

is public relations efforts -- like the Philadelphia-area news conference --

that rankle some, especially focusing blame on street criminals as the "real

villains" instead of on a company that has now admitted that it behaved

criminally.

 

Dr. Art van Zee, who has testified at FDA hearings on OxyContin and still

sees dozens of painkiller addicts at his clinic in rural St. Charles, Va.,

compares Purdue's support for programs like "Dime Out a Dealer" to "using a

squirt gun" to try to put out a forest fire while simultaneously "dropping

napalm" through its marketing efforts. "Everyone is entitled to legal

representation, but that is a little different than being a public advocate

for a group," van Zee said. "You don't know what Giuliani knew or understood

about Purdue's role, but he should have found out before he not only

represented but advocated for them."

 

Part of a bigger fight

 

The OxyContin debate has been part of a larger fight in which patient

advocacy groups that are worried about historic undertreatment of pain have

joined with drug companies to argue against regulatory and law enforcement

restrictions on painkillers that might unduly restrict their availability.

 

And they have largely succeeded, with the FDA resisting calls from the DEA

and others to restrict prescribing authority to trained pain specialists and

to limit OxyContin to severe, cancer-related distress instead of allowing it

for "moderate" pain from any cause.

 

Giuliani was a key ally in that debate. He cast himself as an expert because

of his prosecutorial background and his experience with prostate cancer. As

part of his work for Purdue, he agreed to chair a group called the Rx Action

Alliance, which promoted a "balanced" approach that would address abuse but

maintain access for patients -- and, as a by-product, sales for Purdue.

 

With a Web site that featured Giuliani's picture, the idea behind the group

was to try to bring together people with divergent vantage points. In

practice, pharmaceutical companies and groups concerned with pain management

were particularly well-represented. Few of those involved could point to

concrete accomplishments aside from networking and e-mail alerts about new

research or conferences.

 

One abuse-oriented group listed as a participant in early meetings was the

Partnership for a Drug Free America. "Nothing ever came of it," said Josie

Feliz, the group's spokeswoman. "Rx Alliance basically said there is a

problem, and something should be done, but nothing concrete was ever done."

 

The Alliance did, however, provide a platform for Giuliani to spread the

message of "balance." Typically, he would blame dealers, street criminals,

international smugglers, scamming patients, Internet pharmacies and bad

doctors for the epidemic of painkiller abuse, but rarely if ever mentioned

even the possibility of excessive corporate marketing or under-regulation.

 

"Purdue produces one of the most effective pain management medicines in

history, which helps millions of people around the world," Giuliani said in

a 2005 interview with the conservative Washington Legal Foundation. " ... A

balanced approach to the problem is necessary in order to both prevent drug

abuse and continue to provide appropriate and effective care to the millions

of patients... "

 

In that same interview, just a year before negotiating a plea deal in which

Purdue agreed to pay $130 million to settle suits brought by thousands of

OxyContin victims, he warned that lawsuits could create "unfounded fears" in

patients and "stifle the creativity" of drugmakers. (Despite the settlement,

a Giuliani aide noted last week, Purdue still denies liability.)

 

And in April 2006, in a speech at the Center for Practical Bioethics in

Kansas City, he warned of a "climate of fear" that might dissuade doctors

from prescribing painkillers, and linked that issue to questions of patient

choice on experimental treatments.

 

"My great concern with the FDA," he added, "has always been not that they're

not careful enough about medicines, but that they're too careful."

 

To groups concerned about preserving patients' access to pain medication,

Giuliani's advocacy of "balance" was beyond reproach.

 

"That's a term that has been used for quite a bit of time in the pain

community and it's been endorsed by the DEA for a long period of time dating

back to 2001," said Matt Bromley, a spokesman for the Alliance of State Pain

Initiatives, who headed Rx Action's communications committee. "... You're

assuming we don't want any regulations, but we want to ensure the

regulations are balanced. The mayor has expressed the need for that, but

that doesn't mean no more regulations."

 

But for advocates of tougher regulation, it was Purdue's "mantra" coming out

of the mouth of a national "hero." "I always wondered whether the company's

priority was that balance, or to push as much OxyContin out the door as they

could before their patent ran out," Nagel said.

 

Some unclear of his role

 

And some Rx Action participants say that they didn't realize until recently

that Giuliani was actually a Purdue defense lawyer. Bonnie Wilford, a

Washington-area health consultant recruited to coordinate Rx Alliance

information-sharing who Giuliani Partners identified as the "executive

director," said the group avoided issues of regulation and marketing so it

wouldn't be divisive, but Giuliani's ties could make its motives appear

questionable.

 

"Many of us did not understand the depth of his involvement with Purdue,"

said Wilford, who also worries his candidacy could politicize the group. "At

this point I would like to see him hand off. It makes me uncomfortable."

Giuliani Partners said last week that his affiliation with Purdue was well

known, and it had not heard such criticism directly.

 

In the years after Giuliani began working for Purdue and helping it cope

with controversy, OxyContin sales continued to be healthy -- rising from

$1.3 billion in 2001 to $1.4 billion in 2002 and $1.97 billion in 2003,

before the emergence of generic alternatives began a drop to $1.6 billion in

2004 and $1.1 billion in 2005.

 

At the same time, OxyContin itself has continued to be a problem. It is

still listed as a big contributor to prescription drug abuse among the

young, according to recent federal surveys. Congressmen from Kentucky and

Virginia, citing continuing abuse in their districts, have asked the FDA to

revisit OxyContin in the wake of the plea deal but have so far been

rebuffed.

 

Fair or not, that history has caused some to transfer their anger at Purdue

to Giuliani. Karen Engle directs Operation Unite, a federally funded law

enforcement program to combat prescription drug abuse in 29 eastern Kentucky

counties. She says OxyContin continues to be overprescribed for such

problems as dental pain and blames its continuing abuse on under-regulation.

 

"They have hired anyone that they can afford, and they have hired the best,"

she said. "I'm disappointed in Giuliani, but not surprised. I just wonder if

he's aware of all the families that have lost loved ones."

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