Fifty million Americans live with chronic pain, caused by cancer, other diseases and disorders, and accidents. Another 25 million live with acute pain caused by surgery or accidents. For these people, the new drug OxyContin, with its powerful, but slow release formula, can be a lifesaver.
But OxyContin is getting into the wrong hands, and for addicts who tamper with the slow-release pills the effects can be devastating. And in a federal effort to crack down, some doctors, who say they were just doing their job, have even been arrested. Other physicians say they are staying away from prescribing pain pills, even for patients who need them.
This week on The Infinite Mind, we go beyond the headlines to explore the medical and ethical issues raised by this controversial medication, and the new federal strategy for fighting prescription drug abuse which some doctors say turns them into agents of law enforcement. We hear from an attorney who says the medication saved her life, and from a college student from a leading university who says OxyContin addiction almost destroyed him and his friends. Guests also include Dr. Russell Portenoy, Chairman of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York who discusses the chilling effect he says agressive law enforcement has on medical care; Elizabeth Willis, Chief of the Drug Operations Section of the DEA's Office of Diversion Control; and medical ethicist Sandra Johnson, professor of health, law and ethics at St. Louis University, who questions whether one more intrusion into the "doctor/patient" relationship is a good thing.
Plus, commentator John Hockenberry wonders: when we weigh the damage caused by pain against the threat of drug abuse, can anybody ever win?
Host Dr. Fred Goodwin begins with an essay in which he says that, as a physician, he finds the most disturbing - and largely untold -- aspect of the story of OxyContin is the impact that it's having on the relationship between doctors and their patients. Today, many factors are eroding the confidentiality of the doctor-patient relationship and the freedom to choose the best treatment for patients. Doctors are forced to disclose elements of treatment to private and government insurers, and their managed care contractors. Medical decisions are constantly second-guessed by distant clerks who can't possibly know or understand the complexities of each patient's individual situation. Pharmaceutical companies monitor how much of their drugs doctors prescribe … and contact them to ask about it.A volatile element has been introduced into this already complicated environment - law enforcement, and the fear of criminal prosecution. Across the country, police and federal prosecutors are requiring that doctors be certain that their patients are telling them the truth when they talk about being in pain. If a doctor trusts the patient and is wrong, he or she could be held criminally responsible. Decisions about what medications to use and how to use them, generally the purview of state medical licensing boards, have become the basis of criminal charges that can not only destroy a career but can put a doctor in jail for decades. Previous "get tough" efforts have put a chill on legitimate treatment, while having little or no impact on illicit use. While doctors tend to follow rules, criminals do not.
There are two sides to OxyContin. For those suffering from chronic pain, it can literally be a lifesaver. But, as with any opioid medication, for those who abuse the drug, often by tampering with it, it can be almost as addictive as heroin. To begin today The Infinite Mind's Marit Haahr tells the stories of two people whose lives have been affected by the drug in dramatically different ways.
OxyContin is a semisynthetic opioid medication used to treat chronic pain. It's what's called a Schedule II narcotic, putting it in the class of approved drugs with the highest potential for abuse. What makes it different from most other prescription opioids, like Percocet or dilaudid, is its time-release formula, which administers a steady dose of the drug over a 12-hour period. This makes it easier for patients to stick to their regimens and, perhaps most importantly, allows them to sleep through the night. Many people suffering with severe, chronic pain say it changed - or even saved -- their lives. Mary Vargas, who is now a lawyer in Maryland, suffered severe, chronic pain following a car accident in 1996. She says, "The first medication that worked for me was OxyContin. I was prescribed OxyContin for about four years. That was the only thing that enabled me to finish law school, pass two bar exams, get the kind of job I dreamed of, and start thinking of having a family."
Vargas describes the beneficial side of OxyContin. But there's also another side. Because of the drug's time-release formula, each pill contains a heavy dose of the active ingredient, oxycodone. The FDA, the drug's manufacturer (Purdue Pharma), and doctors originally believed that because that dose was released slowly, the risk of addiction would be much lower than for other opioids. But it didn't take long for recreational drug users to realize that by crushing the pill and snorting or injecting it, they could get the whole massive dose of the drug at once. Aaron, who asked that we not identify him too specifically, is a student at a leading college in the Northeast. He became addicted to OxyContin after being given it by his brother and a trusted friend. He says he had no idea what he was getting into. He wishes someone had educated him and his friends about the seriousness of abusing the drug. He says of his friends, "They have this illusion that because it comes in a prescription bottle and not a baggie, that it's any cleaner or safer than heroin.... If I had known somebody was handing me heroin, I probably would've thought twice about it or not done it at all." Aaron was able to detox, although he says the withdrawal was horrendous: "Withdrawing off OxyContin was a painful and traumatic experience. You're sick as you could ever be, and you know where relief is. And if you know it's easily obtainable, it's almost impossible to go through that and not get some drug for yourself." Some of his friends were not so successful. He even knows people who have moved on to heroin, because it's cheaper than OxyContin.
For pain patients like Mary Vargas, the media attention given to OxyContin abuse has only made life more difficult. She says, "Going to the pharmacy is like going into battle...Very often patients treated as criminals first and patients second."
Later in the program, Elizabeth Willis of the Drug Enforcement Administration describes the President's new National Drug Control Policy. The hope is to crack down on the abuse and diversion of prescription medications. But doctors, patient advocates, and medical ethicists are concerned that law enforcement is already having serious consequences for pain patients. Emily Fisher has a special report.
In the past five years, federal and state law enforcement authorities have charged several hundred doctors with offenses related to the prescribing of controlled substances. Allegations range from prescribing outside the bounds of medical practice to drug trafficking to homicide. Many doctors in the highly specialized field of pain treatment fear these high-profile arrests will hurt patients. Dr. Russell Portenoy is Chairman of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York City. He says that opioids are extremely effective for treating pain, restoring many patients to active, productive lives. But, because opioid medications can be abused, primary care doctors are already wary of prescribing them. Criminal investigations, he says, are likely to make the situation even worse: "Pain specialists are very concerned that primary care physicians are reluctant to prescribe, not because the clinical skill set is so challenging but because they are afraid they will become the objects of scrutiny on the part of law enforcement and the regulatory agencies in each state, and, in fact, federal law enforcement as well."
The Drug Enforcement Administration points out that the number doctors arrested for diversion of controlled substances is proportionately small - in 2003, there were 736 investigations, resulting in 51 arrests. That's out of a total number of almost 1 million doctors with the right to prescribe controlled substances. But ethicist Sandra Johnson agrees with Dr. Russell Portenoy that criminal investigations are having a chilling effect on doctors. Johnson is professor of health, law and ethics at St. Louis University. She studies the legal, regulatory, and financial issues related to the prescription of controlled substances for pain. She says numbers are not the issue: "You don't have to hear many stories, if you're a physician in practice, of physicians being arrested, physicians being led away in handcuffs, patients' files confiscated, to understand that the risk in numbers is small but in terms of impact, it's devastating."
Experts agree that the under-treatment of pain is already an enormous public health problem in this country. According to the American Academy of Pain Management, about 50 million Americans live with chronic pain, caused by cancer, other diseases and disorders, and accidents. Another 25 million live with acute pain caused by surgery or accidents. A 1999 survey by the American Pain Society found that 2 out of 5 people with moderate to severe pain were unable to find adequate pain relief. In recognition, Congress has named this the Decade of Pain Control and Research. Siobhan Reynolds became so frustrated with trying to get good care for her husband, that she founded the Pain Relief Network, an advocacy organization for pain patients and doctors. Through her work, she's spoken to hundreds of desperate pain patients. Reynolds says, "You can't imagine what it's like to be sort of set upon by society, because you find yourself in this incredibly vulnerable position where you're ruined by the pain. You're feeling your life leave you. You're feeling your ability to function leave you. You can't perform your duties. You can't have spousal relations. You can't do any of the things people do, and, when you try to go get help for that, you are absolutely turned away. The under-treatment of pain is an appalling reality in America. It effects the most profoundly ill people in America in ways I think most Americans would find devastating and mind-boggling."
Pain patients are under-treated. Abuse and diversion are problems. It seems doctors are becoming more and more afraid to prescribe opioids. But what is the solution? One of the programs proposed in the President's new National Drug Control Strategy is an increase in electronic prescription monitoring programs, which automatically create statewide databases to track prescriptions for controlled substances. In California, monitoring programs are already in place. Dr. Wendye Robbins, a pain specialist at Stanford University, says she's glad that the government helps her figure out who might be diverting drugs or doing what's called "doctor shopping" -- getting prescriptions for the same medication from multiple doctors. She says, "I have received over time a number of notifications about individual patients who are receiving prescriptions from me and from other people and typically I'll get a letter that says something that, 'Mrs. Mary Smith is receiving prescriptions from you and from the following other doctors. We want to make sure you know that. And if you know that and you believe that is acceptable, you did not need to respond to this letter. However if this is unusual or new to you, please take appropriate action.' Dr. Robbins says that doctors practicing good medicine should not be afraid. In fact, she thinks they'd be surprised to find out how difficult it can be to build a case against a doctor.
The President's new National Drug Control Strategy also calls for wider training and education for doctors in the appropriate use of opioids. Ethicist Sandra Johnson says that as these programs are put in place, it's important that they be well balanced. "One thing we have to be careful of when we start taking steps to prevent diversion is that we don't inadvertently harm patients in pain. So it concerns me if physicians are given standards, education, and regulatory training on diversion -- which often means to be suspicious of patients or groups of patients -- but then are not given, at the same time, the same quality of training on treating pain and recognizing and treating addictions."
To contact Ms. Reynolds or the Pain Relief Network, please write to: Siobhan Reynolds, Pain Relief Network, Inc., PO Box 231054, New York, NY 10023. Or visit: www.painreliefnetwork.org.
To contact Dr. Portenoy, please write to: Dr. Russell Portenoy, Chairman, Dept. of Pain Medicine and Palliative Care, Beth Israel Medical Center, First Avenue at 16th St., New York, NY 10003. Or visit: www.stoppain.org.
To contact, Dr. Robbins, please write to: Dr. Wendye Robbins, Stanford University, Pain Management Center, 300 Pasteur Dr., Room A408, Stanford, CA 94305. Or visit: http://paincenter.stanford.edu.
To contact Ms. Johnson, please write to: Sandra Johnson, Saint Louis University School of Law, 3700 Lindell Blvd., St. Louis, MO 63108. Or visit: law.slu.edu.
On March 1, the Drug Enforcement Administration, the Drug Czar, the Food and Drug Administration, and the Surgeon General jointly released a new National Drug Control Strategy. It details new federal programs intended to curb the abuse and black-market sale of prescription drugs, including OxyContin. The President's 2005 budget requests a $20 million increase -- for a total of $138 million -- for prescription drug diversion control programs.To discuss this new policy and the Drug Enforcement Administration's ongoing efforts to curb prescription drug abuse, Dr. Goodwin interviews Elizabeth Willis, Chief of the Drug Operations Section of the DEA's Office of Diversion Control.
Ms. Willis says that the diversion of prescription drugs is not a new problem, but it is an increasing one. She says in 2002, 6.2 million Americans age 12 and older abused prescription drugs -- that's 2.6% of the population.
She says that even thought the prescription drug Vicodin is diverted more frequently, OxyContin is more dangerous because it contains more of its active ingredient. Because of the time-release formula, each OxyContin pill contains between 20-80 mg. of the active ingredient, oxycodone. Percodan and Percocet contain only 5-7.5 mg. of oxycodone, and Vicodin contains only 5-7.5 mg. of its active ingredient, hydrocodone. Therefore, when OxyContin is crushed and snorted, the risk of overdose is much greater, as is the risk of addiction, since the level of the drug in the blood would rise much more quickly.
Dr. Goodwin asks Ms. Willis how the DEA learns about doctors who are diverting prescription drugs. She says it's often through local law enforcement or through friends or family members who are concerned that their loved ones are getting prescription drugs for non-medical purposes. Dr. Goodwin then asks how they DEA can determine what's medical or non-medical, especially since it's essential that doctors believe their patients, and, when it comes to pain, they often have nothing to go on but their patient's word. How, he asks, can doctors be held criminally responsible for knowing whether their patients are telling the truth? She says the DEA doesn't hold doctors responsible if they are prescribing in good faith --- she knows it's not uncommon for people to feign medical problems to obtain drugs. In those cases, she says, the DEA would advise the doctors to be cautious. She says that the cases that become criminal investigations are the ones in which doctors are writing prescriptions in exchange for money or sexual favors.
They then discuss key elements of the new National Drug Control Strategy, including going after illegal Internet sales of prescription drugs, increasing the number of state prescription monitoring programs, and ensuring wider education and training on appropriate pain management and opioid treatment.
To contact Ms. Willis, please write to: Elizabeth Willis, Chief, Drug Operations Section, Office of Diversion Control, Drug Enforcement Administration, 2401 Jefferson Davis Highway, Alexandria, VA 22301. Or visit: www.dea.gov.
For more about the new National Drug Control Strategy, please visit: www.whitehousedrugpolicy.gov.
Finally, commentator John Hockenberry wonders: when we weigh the damage caused by pain against the threat of drug abuse, can anybody ever win?
- Marit Haahr
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