Barbara van Rooyan: Testimony before the U.S. House of Representatives

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.