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DRUGS |
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Testimony before the U.S. House of Representatives
Statement
of Barbara van Rooyan
Committee on House Government Reform Subcommittee on Criminal Justice,
Drug Policy, and Human Resources
July 26, 2006
Introduction
Chairman Souder and other distinguished members of the Criminal Justice,
Drug Policy and Human Resources Subcommittee, thank you for the opportunity
to testify today regarding the problem of prescription drug abuse.
My name is Barbara Van Rooyan. I am a California Community College
faculty member and counselor, the wife and daughter of physicians,
the mother of two sons. My first-born son, Patrick Stewart died on
July 9, 2004 at 24 years of age after ingesting just one OxyContin.
He had no other drugs in his system and only a small amount of alcohol.
He was a SDSU graduate, a graphic designer and a certified personal
trainer. His friends described Patrick as "the one who puts you back
on your bicycle after you fall off". He made the tragic mistake of
believing someone at a 4th of July celebration when he was told that
OxyContin was "sort of like a muscle relaxant, that it was prescription
and FDA approved, so therefore safe". Close friends say that Patrick
had never before taken an OxyContin, did not know it was equivalent
to "heroin in a pill".
As happens with some who are intolerant to opioids he stopped breathing
in his sleep. Found by his friends he was rushed to the ER at UC San
Diego Medical Center. There he remained in a medically induced coma
to control seizures resulting from lack of oxygen to his brain. After
five days Patrick was reported to have no brain activity. As I believed
would be his wish we arranged for organ donation as we said our last
goodbyes. Only his lungs could not be shared; the OxyContin had destroyed
them. At the time I knew next to nothing about OxyContin, prescription
drug abuse or grief.
But in my grief I learned very quickly.
And what I learned I felt compelled to share with others. Therefore
in the two years since Patrick's death I have become involved in youth
and family education regarding prescription drug abuse, governmental
regulation of controlled substances, and physician education regarding
pain management. In addition I gained knowledge of expansion of the
California Prescription Monitoring Program facilitated by other parents
who lost both a son and daughter.
Youth and Family Education
As a counselor, employed by a college district of 80,000 students,
I applied for and was granted a partial sabbatical to concentrate
on prescription drug abuse education for students, faculty, staff
and administration. This past year I have told Patrick's story hundreds
of times and upon hearing his story, people tell me theirs. From them
I learned that. . .
--Many young people think taking a prescription drug is not the same
as "doing drugs"
--Many teachers, counselors and administrators are not aware of the
abuse of prescription drugs, the scope of the problem, nor the signs
of misuse (no odor, no paraphernalia = no drugs)
--Many young people have a friend or relative who was prescribed OxyContin
for an injury, back pain or arthritis and now is unable to stop taking
the drug.
--High school health classes include segments on illicit drugs but
in most classes prescription drug abuse is not addressed.
--Some people obtain OxyContin from their own family doctors by "faking
pain".
--Most physicians have very little training in opioid prescribing
or addiction; as a result many are not selective in prescribing opioids
nor do they make adequate use of non-drug interventions.
--Easy availability of prescription drugs from doctors, family medicine
cabinets and the Internet, combined with young people's feelings of
invincibility has led to more deaths and addictions than I ever imagined.
--Prescription drug abuse education needs to target parents as well
as youth.
DrugTalk programs and tools, particularly, "The New Face of Drugs"
DVD are valuable educational tools that I discovered during this sabbatical
year. They can be used in schools or homes.
Governmental Regulation In the fall of 2004, just a few short months
after Patrick's death I learned that stories of hundreds of OxyContin
deaths could be found on the website of Ed Bisch (www.oxyabusekills.com)
who lost his son Eddie to OxyContin in 2001. I also learned from the
website that the Anesthetic and Life Support Drugs Advisory Committee
of the FDA had voted in September 2003 NOT to restrict OxyContin for
use with severe pain only. Such a restriction would powerfully reduce
the number of deaths and addictions to OxyContin without compromising
terminally ill or dying patients' access to OxyContin. Yet the FDA
has failed to take this step. When I discovered that the membership
of the Advisory Committee had changed since the 2003 vote I began
to contact FDA members with Patrick's story and a request for the
new committee members to meet to discuss OxyContin. Although I was
put in touch with an FDA ombudsman and although Senator Feinstein
wrote the FDA requesting that the committee meet, our requests went
unheeded.
In February 2005 my husband and I submitted Citizen Petition 2005P-0076
to the FDA requesting that OxyContin and Palladone be reformulated
as abuse resistant and relabeled for severe pain only. Despite many
attempted contacts with the FDA I have received only one communication
from the agency- a letter stating that more time was needed to review
the petition requests and I would be notified of any decision. Subsequently,
Palladone has temporarily been removed from the market for reformulation.
However, in June 2006, without first addressing the continuing problems
with OxyContin, the FDA approved an additional sustained release opioid,
Opana, manufactured by Endo Pharmaceuticals.
In the fall of 2005 a meeting of the Advisory Committee was tentatively
scheduled for November 10, 2005. I contacted the executive secretary
and was informed that it was to be a closed meeting; therefore the
agenda was not available to the public. She indicated that there would
be a short public session prior to the closed meeting; I could attend
or submit a written statement. I chose the latter, registered for
the open session and submitted a written statement and the Citizen
Petition for each committee member. Transcripts of the open session
contain no mention of my written statement or of OxyContin and of
course, there is no public transcript of the closed session. To my
knowledge the Anesthetic and Life Support Advisory Committee has not,
to date, responded to many requests to address OxyContin or Citizen
Petition 2005P-0076.
In May 2005 HR 2195 was introduced in The House of Representatives,
asking for a recall of OxyContin. After communications with Congressman
Lynch's staff it is my understanding that the recall would be temporary,
for the purpose of reformulation such as requested in Citizen Petition
2005P- 0076. The bill currently resides with the Health Subcommittee
of Energy and Commerce. I have sent letters to Chairman Waxman and
all subcommittee members requesting support for HR 2195 and have asked
others to do so also.
Just five months before my son Patrick died, Fred Pauzar, another
parent who lost his son to OxyContin, also gave testimony before this
subcommittee. Mr. Pauzar made an impassioned plea for Congress to
be wise and courageous in taking steps to monitor and curb the improper
marketing and use of OxyContin. Today, two years later, OxyContin
remains on the market for use with moderate pain and new sustained
release opioids continue to receive FDA approval.
Physician Education
In California, since October 2001, physicians have had a one time
only requirement of 12 hours of continuing education in pain management
and treatment of terminally ill and dying patients that must be completed
by December 2006. Not all states require even this minimal education.
The July 2005 report from the National Center on Addiction and Substance
Abuse at Columbia University states that 4 in 10 doctors surveyed
say they received no training in medical school on prescribing controlled
substances; more than half received no training on identifying prescription
drug abuse or addiction and three fourths said they had no training
in medical school identifying diversion of prescription drugs for
illicit purposes.
Yet in 2002 OxyContin was, by far, one of the most widely prescribed
opioid medications in the U.S. with an increase of 380% between 1992
and 2002. Purdue Pharma's false and aggressive marketing of OxyContin
and the FDA's approval of OxyContin for moderate pain are primary
reasons for this increase.
In addition, the Waismann 2005 Opiate Dependency Survey indicates
that 71% of patients with opiate dependency were originally prescribed
opioid medications by their doctors.
The question becomes, "How can so many prescriptions for opioids be
written by so many doctors with so little training?
Consider that:
--The majority of physicians do not know that the long term safety
and effectiveness of opioids for management of non- malignant pain
have NOT been substantiated.
--The majority of physicians do not know that patients seeking pain
relief for chronic, non malignant pain often have underlying psycho
social problems and need psychological or rehabilitation services
or would respond well to other non- drug interventions.
--In busy medical practices, particularly primary care and family
practice office settings, a thorough diagnosis of the cause and type
of pain and a balanced, multifaceted pain treatment program are often
difficult to achieve. The result is that often pain therapy is based
not on science but on intuition or hearsay, and ends up aggravating
rather than ameliorating prescription pain medication abuse and addiction.
--Many good physicians relied upon false marketing information regarding
OxyContin from an aggressive Purdue Pharma sales force that was prompted
by greed. The result was an expansion of opioid therapy for patients
who might benefit more from non-drug interventions or alternate drugs,
without the accompanying risks of opioids.
My husband, a plastic surgeon and consultant for The Medical Board
of California, and I have taken some initial steps to help improve
and expand California's continuing medical education regarding pain
management. Other physicians, such as Dr. Stephen Gelfand, a South
Carolina rheumatologist who works with a large population of chronic
pain patients, are working to educate general practitioners of the
efficacy and safety of non-drug therapies, alternate medications and
multidisciplinary care. However, the surface has only been scratched.
Comprehensive pain management education with a balanced, multi- faceted
approach is needed for all physicians.
Prescription Drug Monitoring Programs
Prescription drug monitoring programs are also essential to combat
the tide of death and addiction from prescription drugs. In California,
Bob and Carmen Pack, with the help of State Senator Torlakson introduced
SB 734 which expanded California's Prescription Drug Monitoring Program
into the current Controlled Substance Utilization Review and Evaluation
System, known as C.U.R.E.S. SB 734 became effective January 2006 but
is only the "first leg of the program". The "second leg" of the program
is essential and would provide an online narcotic prescription drug-monitoring
program. Unfortunately, state funds for this portion of the program
are not available. The Packs are looking to the pharmaceutical companies
and the federal government for financial assistance. Tragically, the
new program comes as a result of the death of the Pack's two children,
age 7 and 10. The children were hit and killed by a car driven by
a woman addicted to Vicodin and under the influence at the time. Prior
to the crash the woman had been given six Vicodin prescriptions from
six different doctors at the same HMO; the physicians had corroborated
none of the injuries she complained about.
Conclusion
There is no ONE culprit in this epidemic of prescription drug abuse.
It would be simple and understandable for a grieving parent to hold
only one party responsible and focus efforts on that one party. However,
I believe that it will take a concerted effort by many individuals,
groups and agencies to stem the tide of deaths and addiction to prescription
drugs, most notably OxyContin, that continues to plague our country.
Sadly, correspondence from Richard Blumenthal, Connecticut State Attorney
General, dated July 31, 2001 to Richard Sackler, President of Purdue
Pharma (access at: www.ct.gov/ag/lib/ag/press_releases/2001/health/oxy.pdf)
was
ignored. Had Mr. Blumenthal's suggestions been heeded my son and many
others might be alive today.
Based on my work of the past two years I believe that necessary steps
include but are not limited to:
1)Substantial unrestricted grants from pharmaceutical companies and
increased federal appropriations for:
--Youth/family prescription drug abuse education
--Increased mandatory physician education regarding selective opioid
prescribing and a balanced, multifaceted approach to pain management
--Treatment and Rehabilitation Programs
--Nationwide prescription monitoring programs
2)More assertive and comprehensive implementation by the FDA of its
basic responsibility to protect citizens by increasing restrictions
such as those requested in Citizen Petition 2005P- 0076.
I come before this committee today because my son is dead; I will
forever mourn. I also come before this committee today because my
son stands at my right shoulder and tells me each day, "Mother, It
is better to light one candle than to curse the darkness". I will
light as many candles as necessary and hope that you will too.
Thank you. |
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