Written Testimony of Frederick W. Pauzar

Before the Government Reform Committee�s

Subcommittee on Criminal Justice, Drug Policy, and Human Resources

Winter Park, Florida, February 9, 2004

Chairman Souder, Representative Mica and other distinguished members of the Criminal Justice, Drug Policy and Human Resources Subcommittee, thank you for the opportunity to testify before you today. 

My name is Fred Pauzar and I am the father of Chris Pauzar, a brilliant 22-year old man who died from a toxic dose of OxyContin 76 days ago, on November the 25th, 2003.  Although the tragedy of losing a child is not something one should ever be forced to imagine, I will simply submit to you that the pain from this loss is so great it overshadows nearly everything else.  Each life that can be saved through the enactment of proper legislation and regulatory standards and procedures will be a life whose potential for greatness, whose contributions to mankind, may still be achieved.  Each premature and needless death - such as that of my own son - is a heart shattering occurrence that also deprives society of all the brilliance, all of the achievements, all of the greatness that will now never come to pass. 

OxyContin was originally prescribed to my son for a minor shoulder injury, an injury for which he might have taken acetaminophen or ibuprofen.  When he found it difficult to stop taking OxyContin, he was assured by his physician that its continued use was safe and he carried on.  His frequency of dosage increased and, eventually, he was taking 200 milligrams or more per day.  All along he was reassured that the long-term use of this drug wasn�t harming him, both by his physician and by Purdue Pharma literature that suggested the appropriateness of prescribing OxyContin for pain that would be ��expected to persist for an extended period of time.�  He concluded logically that, the drug is suitable for use on an extended basis and that taking it on an extended basis would not be harmful. 

When my son ultimately realized that he was uncontrollably addicted to this drug, experiencing flu-like symptoms and great physical and emotional distress when he stopped using it, he needed and sought regular group and private therapy and other medical support to detoxify and to learn to live without OxyContin in his life.  Unfortunately, after breaking the pattern of daily use, he wrongly decided to take it into his body one more time, saying that �one more time won�t kill me� on the evening that he died. 

Since my son�s death, since learning of the greatest pain any parent might experience, I have been stunned by the facts related to the marketing, prescribing, use and abuse of the drug that killed him. And I have been astounded that a clear and insidious correlation exists between the market penetration this drug has achieved and the toll of death it has left behind. 

OxyContin came into existence in 1995, when Purdue Pharma deceived the U.S. Government by engaging in ��inequitable conduct before the Patent and Trademark Office�� (January 5, 2003, U.S. Dis. Judge Sidney H. Stein) in order to patent OxyContin.  Its sales have literally skyrocketed, thanks in part to uniquely aggressive advertising and the promulgation of performance claims that have not held up to scrutiny.   

In 1995 and 1996 it was sold as a chronic pain medication for use with cancer patients.  Then in 1997 Purdue Pharma began to push this drug into new markets such as back pain and injury. At the same time the company reached down into moderate pain treatment, it adding a more potent dosage, beginning the manufacture of 80-milligram tablets to complement the smaller 10, 20 and 40-milligram pills already on the market.  By 1998, fully two-thirds of all Oxy prescriptions issued are for non-cancer pain. 

Cleverly, Purdue Pharma paid for hundreds of physicians to ravel on junkets where they were educated about the benefits of OxyContin, a Schedule II drug without a �ceiling� on dosage.  Those physicians were, in the manner of a pyramid building fashion, told they would be paid speakers� fees for talking to other doctors about the benefits of OxyContin 

By 1999, Purdue Pharma�s objectives included a reach toward one-half billion dollars in sales of their star drug, with their marketing efforts targeting more groups including seniors with direct to consumer (DTC) advertising.  Again, while the marketing effort seeks to aggressively broaden market penetration, the manufacturing side of the company delivers an even more potent tablet, a 160-milligram pill. 

By 2001, Purdue Pharma had comfortably rocketed past the one billion dollar mark in sales from this single drug, with the Company noting in passing that the challenges presented by mounting evidence of OxyContin abuse in Florida, Maine, Ohio and other states ��will continue to be a threat to the continued success of OxyContin tablets.� 

In 2002, OxyContin sales hit the $1.2 billion level, representing more than 80% of Purdue Pharma�s total revenue and the vast majority of its profitability, due in part to the advantage handed Purdue Pharma by the FDA. As Purdue Pharma�s marketing group noted in the face of mounting evidence that deaths in Florida and other states from Oxy exceed deaths from heroin, �It is unlikely that an opioid approved by the FDA in the future will have as broad of an indication [or indicated usage] as OxyContin now enjoys.� 

And in this regard Purdue Pharma is surely correct.  With the unwitting actions of many fine physicians who relied on the marketing promises made by an aggressive Purdue Pharma sales force, with the calculated and illicit actions of a small percentage of doctors who abuse the system, and with a system that statewide and federally has been slow to recognize the danger of this drug and respond in appropriate fashion, the daily death toll continues to mount. 

In Florida alone, more than one person dies on average each day from the intake of Oxy.  The loss is truly incalculable but nonetheless devastating and real. 

May you have the wisdom and the courage to deal effectively with this threat to our children and our society overall by taking effective steps to monitor and curb the improper marketing and use of this devastating drug. And may you never know the pain that I, along with thousands of parents before me and hundreds more since, now feel. 

Thank you.

Lawmakers discuss controls of prescription drugs
Tighter regulation is likely for potentially addictive medications such as OxyContin, members of Congress said at a Winter Park hearing.
By Robyn Suriano
Sentinel Medical Writer

February 10, 2004

WINTER PARK -- Citing widespread abuse of the painkiller OxyContin, members of Congress said Monday that doctors, pharmacists and drug manufacturers should brace themselves for new government controls of potentially addictive prescription drugs.

The health-care industry's arguments against tighter monitoring -- such as patient-privacy concerns and the risk of scaring away legitimate pain patients -- just don't cut it today, said U.S Rep. Mark Souder.

The Indiana Republican said the "leave-it-alone world" no longer exists and earlier chided a panel that included a doctor, pharmacist and drug-company representative.

"Frankly, I am very frustrated by your testimony," said Souder, who described himself as being sympathetic to the health-care industry but said he is growing weary of "getting the crap kicked out of me" because of his support.

Some of the measures discussed were shutting down Internet pharmacies that indiscriminately dispense drugs that can be addictive; installing statewide systems to track every prescription written for the drugs; and tougher enforcement of existing penalties for doctors and pharmacists who break the law.

Souder said, "We want to make sure we don't overreact, but I'm sorry, there are going to be controls. To not act suggests irresponsibility."

The lengthy hearing was held at Winter Park City Hall, with a small contingent of people who carried placards bearing their loved ones' photos and the words "OxyContin kills" in red letters. They wore yellow buttons that said: "RAPP: Relatives Against Purdue Pharma," the Connecticut-based pharmaceutical company that makes OxyContin.

The only relative of a pain patient to testify was Fred Pauzar of Winter Park. He told the Congress members of his son's death from what he described as an OxyContin overdose in November. He said Christopher Pauzar, 22, was prescribed the medication for a shoulder injury, became addicted, and took it on the night he died.

Pauzar, who runs an architecture firm, partly blames Purdue Pharma's marketing practices, saying the drug company's aggressive salesmanship has prompted doctors to increasingly prescribe the medication for lesser ailments. He thinks it should be banned for "moderate pain."

"May you have the wisdom and the courage to deal effectively with this threat to our children," he told the panel, "by taking effective steps to monitor and curb the improper marketing and use of this devastating drug."

Purdue Pharma generally blames overdoses on drug abusers who use the pain medication illegally, and the company says the drug is rarely addictive when used as prescribed.

Company spokesman James Heins said his company actively educates doctors about OxyContin and its potential dangers. He said prescription-drug abuse goes far beyond his company's drug.

"It's the one that's getting all the attention today," Heins said, "but it's an issue of prescription-drug abuse. OxyContin is only one part of the problem."

The hearing also drew speakers who cautioned against measures that would prevent doctors from prescribing drugs such as OxyContin when needed. Another lawmaker, U.S. Rep. Charlie Norwood, R-Ga., said untreated pain is already a major public-health problem in the United States.

A dentist, Norwood said legislators would be remiss if they didn't keep legitimate pain patients in mind as they addressed the problems.

"Unless you've been there, unless you have had that pain and can barely stand it, you don't know what it's like to live with it," Norwood said.

A representative from Purdue Pharma told the congressional subcommittee that abuse of painkillers dates to the Civil War, when battle-injured men became addicted to morphine in what used to be called "soldier's disease."

The problem won't go away with a limited attack on one drug, said Jack Henningfield, vice president of research and health policy for Pinney Associates, a health-consulting firm representing Purdue Pharma.

"We have to be careful [that we] don't squeeze the balloon in one place and it pops up in another," Henningfield said.

Though the hearing was aimed at prescription-drug abuse in general, OxyContin was the sole focus of discussion about specific drugs. OxyContin is an opiate-based painkiller that came on the market in 1995 for cancer patients. It has been prescribed increasingly in the years since for a variety of ailments, and illegal uses of the drug have flourished, according to drug officials at the hearing.

Illegal use of OxyContin can produce a heroinlike high, giving the medication the street nickname "heroin in a pill."

An Orlando Sentinel investigation last year found that the number of people dying from oxycodone, the active ingredient in OxyContin and other painkillers, surpassed those who overdosed on heroin in Florida during 2001 and 2002. Florida medical examiners reported 573 oxycodone overdose deaths in those years, compared with 521 heroin deaths.

Through autopsy reports, police reports and interviews with relatives and witnesses, the Sentinel was able to identify a specific medication in 247 of the oxycodone deaths. In 83 percent of those 247 cases, OxyContin was the drug identified.

Monday's hearing was held at the request of U.S. Rep. John Mica, R-Winter Park, who expressed his frustration that there isn't more coordination among government agencies to deal with illegal prescription-drug use.

He asked representatives of the Food and Drug Administration and the Drug Enforcement Administration to outline what obstacles are hampering their ability to better regulate the drugs and how they would like penalties against offenders to be increased.

Afterward, Mica said he hopes the hearing will provide impetus to future legislation, better education of doctors and pharmacists, along with better communication and cooperation among agencies.

"Just looking at the magnitude of the problem clearly requires some kind of federal" involvement, he said.

Robyn Suriano can be reached at [email protected] or 407-420-5487.

 

Parents sit in on House testimony of OxyContin use

By SARAH LUNDY, [email protected]
 Published by news-press.com on February 11, 2004

Winter Park � Jeff Taylor sat in the city hall chamber�s front row with two poster-size pictures of his son, Matt, who overdosed after taking the controversial painkiller OxyContin at a party last June.

Jeff Taylor, a captain with the Lee County Sheriff�s Office, and his wife, Terri, listen to testimony from expert witnesses during the prescription drug abuse prevention hearing of the Subcommittee on Criminal Justice, Drug Policy and Human Resources on Monday in Winter Park. Taylor�s son, Matt, died of an OxyContin overdose on June 19. Captain Taylor and many other parents of children who died after taking the drug came to the hearing with posters displaying the names and faces of their children. AMANDA INSCORE/news-press.com

The Fort Myers father wanted U.S. Reps. John Mica, R-Fla.; Mark Souder, R-Ind.; Charlie Norwood, R-Ga; and Rick Keller, R-Fla.; to see his 18-year-old son.

The congressmen looked at Matt�s smiling face as they listened to officials in the law enforcement, medical and pharmacy fields talk about prescription drug abuse.

Taylor, a Lee County sheriff�s captain, and his wife, Terri, drove three hours to be at the hearing before the U.S. House of Representatives subcommittee on criminal justice, drug policy and human resources.

�This is sure something I never thought we would be involved in,� said Terri Taylor, who married Taylor shortly after Matt died.

For five hours, 12 witnesses � including the Florida Pharmacy Association president, a Drug Enforcement Administration agent, an Orlando Anderson Cancer Center doctor and a U.S. Food and Drug Administration representative � spoke about the complexity of the prescription drug abuse problem and the need for something to be done, especially about OxyContin.

By chewing, snorting or shooting OxyContin, abusers get a morphine-like high, according to the U.S. Drug Enforcement Administration. A large dose can cause severe respiratory depression, which can lead to death by slowing a person�s breathing to dangerously low levels.

The painkiller produced by Purdue Pharma hit the market in 1995 and is already the most widely known example of prescription drug abuse, said Thomas Raffanello, DEA special agent in charge in the Miami division.

�DEA has never witnessed such a rapid increase in abuse and diversion of a pharmaceutical drug product,� he said.

However, he later told the panel that the DEA�s biggest drug problems in Florida are heroin and methamphetamines.

Prescription drug users are getting the drugs a number of ways, such as doctor shopping, prescription fraud, robbery and the Internet.

Taking away access to the drugs, such as OxyContin, will not solve the problem, the witnesses agreed.

�We must ensure that prescription pain medications are available to the patients who need them and that we do all we can to prevent these drugs from becoming a source of harm and abuse,� said Karen Kaplan, president and chief executive officer for Last Acts Partnership, which is a national not-for-profit organization dedicated to improving care near the end of life. Purdue Pharma advocacy senior director Pamela Bennett agreed.

�It�s going to take all of us to be part of the solution,� she said.

By the end of the hearing, Taylor seemed hopeful that something would change.

�But actions speak louder than words,� he said as he carried the pictures of Matt out of the chamber.