After three decades of chronic, searing pain, Marie Dabrowski was finally able to sleep. She was able to think. And sometimes, thanks to her new pills, she could almost forget about her fibromyalgia, a mysterious nerve disorder characterized by fatigue, migraine headaches and full-body aches.
But Dabrowski's respite did not last. The medication responsible for her two-year break from daily misery was OxyContin. And about a month ago, Dabrowski's doctor cut her off. The move had nothing to do with callousness or lack of concern, says Dabrowski, who asked that her doctor remain anonymous. Instead, the doctor was spooked by a proposed Virginia law designed to intensify scrutiny of physicians who prescribe the drug. In the end, says Dabrowski, it was the prospect of police interrogation that pushed her doctor over the edge.
"When I went in [to her office], her receptionist explained to me that it was the DEA that was the problem and that my doctor was scared of getting in trouble," she says. "I told them that this was dangerous. People on [OxyContin] finally have something that keeps the pain away, and if the pain comes back they're going to commit suicide."
Widespread abuse of OxyContin, a painkiller made by Purdue Pharma LP, was first reported in the media about a year ago. Called "hillbilly heroin" because early cases of addiction surfaced in Appalachia, the pills were being crushed and then snorted or injected by users, who found the drug cheap and easy to obtain. Once touted by its manufacturer as a safe and effective alternative to highly addictive morphine, "Oxy" quickly became the scourge of law enforcement, spreading across the country with lightning speed, leaving hundreds of addicts in its wake.
Even as Purdue hastily promised to produce OxyContin in a form less vulnerable to abuse, legislators in at least 17 states pushed to create strict prescription tracking programs, while others took steps to limit the number of OxyContin pills that people on Medicaid can receive. The Department of Justice has proposed a national crackdown on painkiller abuse, and some states are considering laws that would ban OxyContin, as well as its main ingredient, oxycodone, a synthetic opiate prescribed to millions of patients since 1916.
It is difficult to argue with laws intended to make it harder for addicts to get drugs; and the DEA has said it does not want to limit the supply to those with a legitimate need for relief. But there are dangerous side effects to the new restrictive policies on prescription painkillers -- chief among them, widespread, unnecessary suffering. Patients with chronic pain, routinely undertreated in the past, had in recent years begun to get adequate relief, thanks, in part, to OxyContin, one of the few drugs that reduces or eliminates pain without nausea or damage to vital organs. The onslaught of regulations designed to curtail OxyContin abuse now threatens to reverse these advances.
Increasing numbers of the estimated 30 to 50 million people in the country who suffer from some form of chronic pain say the OxyContin crackdown means they can no longer get adequate or sustained relief. For some, the new rules and medical practices create frustrating delays in receiving medication. But for others, there is no help at all.
Cancer patients and sufferers of debilitating diseases report that they are getting ineffective dosages of OxyContin, running out of places to fill legal prescriptions for it, or finding themselves without doctors, many of whom choose to avoid OxyContin headaches by sending patients to overwhelmed pain specialists struggling with the same regulations.
Our simmering fear of painkiller abuse, brought to a boil by the OxyContin scare, has created a world of hurt for legitimate victims of illness: The war on drugs has increasingly become a war on patients.
"I wake up crying every morning because I don't have anything for the pain," Dabrowski says. "The law isn't even in place, but it's already affecting me. I feel like I'm burning from the inside out."
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Americans have something of a tortured relationship with opioids -- pain relievers derived from real or synthetic opium that work on the central nervous system. Doctors were the earliest targets of prescription drug panic: As early as 1914, with the passage of the Harrison Narcotic Act, the government identified doctors as agents of addiction who needed to be controlled if narcotic abuse was to be abolished. The law, refined by a Supreme Court decision in 1919, made it illegal for doctors to prescribe opioids to addicted patients and required doctors who prescribed the drugs to register with the IRS.
"There was a lot of zealous law enforcement activity after the decision," says June Dahl, a pain policy researcher and pharmacology professor at the University of Wisconsin. "The police went out to get docs and a lot of them were thrown in prison. That's the origin of this whole concept that physicians are the cause of addiction -- that they're the ones who should be held accountable."
State laws passed over the next few decades added more specific hurdles for doctors: stronger penalties for over-prescribing, and in some cases, mandatory use of triplicate forms that gave state regulators a copy of every prescription written for opioids and other highly addictive but medically useful drugs -- a category defined by the government in 1970 as Schedule II narcotics.
Most doctors reacted to the laws -- and a growing public fear of drug abuse -- by avoiding patients with pain that required strong medication. There were, and are, exceptions: Doctors who treat cancer patients have typically plodded through the extra paperwork and state scrutiny in order to prescribe opioids. But the vast majority of physicians in states with triplicate regulations responded to additional scrutiny by dropping opioids from the list of drugs they would prescribe. A survey that Dahl conducted in the mid-90s found that only 60 percent of California's 96,000 doctors -- oncologists included -- were authorized to write triplicate prescriptions, and that only 40 percent of these doctors actually did. Other surveys in other states found similar results.
The advent of managed care has compounded the problem, says Dr. Daniel Carr, founding medical director of the pain management program at Tufts New England Medical Center. Diagnosing chronic pain often requires extra time -- X-rays and the usual tests may turn up nothing, even when patients are visibly suffering -- and managed care demands extra efficiency. Doctors who participate in that system, with its attendant focus on quickly moving patients in and out of doctors' offices, "are extremely pressured for time," Carr says. "Anything that looks like it will take more time is a tremendous disincentive."
Greater obstacles to aggressive pain management resulted in more undertreated sufferers of chronic pain. A handful of doctors, aware of the problem, sought to focus on treatment of pain by forming specialized study groups in the early '70s. But it wasn't until 1985, when an article in the New England Journal of Medicine identified a widespread lack of adequate care, that victims of undertreated chronic pain became more visible to doctors and the public.
The journal article, by Dr. Kathy Foley, offered new medication and treatment guidelines that became the model for doctors treating pain. Medical schools and regulatory boards also responded, gradually, with dedicated training programs and ethical guidelines for the treatment of pain. Tufts University was the first, in 1991, to establish a master's program for doctors in pain studies. By 2000, 24 state medical boards had adopted pain guidelines that specifically advised doctors on the dangers of undertreatment. Meanwhile, large healthcare providers created pain clinics, increasing the number of locations where strong drugs could -- and would -- be prescribed.
And then, out of the blue, came the OxyContin scare. Abuse of the drug began to reverse advances in pain management by early 2001, in concert with a broad crackdown on painkillers. The problem with OxyContin was not its main ingredient (oxycodone hydrochloride), which is found in Percocet and other painkillers, and has been around long enough to be widely prescribed and relatively uncontroversial. The problem was with OxyContin's potency, promotion and chemical formula. OxyContin carried an extremely high dose of oxycodone -- up to 160 milligrams or 16 times the highest dosage available in Vicodin. It was extremely popular (sales exceeded $1 billion in 2000), which made it very accessible. And its time-release qualities were easily defeated by simply crushing the pill.
Towns that didn't have easy access to heroin or other hard drugs became the first "Oxy" hotspots. Rural Maine, western Pennsylvania and the Appalachian areas of Kentucky, Virginia and West Virginia in early 2001 were the areas first hit. But word -- and addiction -- spread fast, and deaths attributed to the drug began to be reported. Calls for legislation and increased law enforcement came quickly, and painkillers of every variety came under new scrutiny.
The first controls of the drug sought to cut off abuse by Medicaid patients. There was no body of data indicating that the poor abused the drug more than wealthier Americans, but by the summer of 2001, six states had introduced legislation making it harder for Medicaid patients to get their pills. Other states followed, with regulations aimed at aid recipients with OxyContin prescriptions or at Medicaid patients in need of pain medication. Vermont, at the behest of its Gov. Howard Dean, who is a physician, ended coverage of OxyContin for all its Medicaid patients. If poor patients needed the pills, said the state's lawmakers, they had to move.
"I'm on Medicaid and I'm scared that the state's going to stop paying [for OxyContin,]" says Sarah Murray, a 51-year-old Louisiana woman on Medicaid who suffers from multiple cysts in her kidneys and liver. "I know in some states they've stopped paying. And if they stop paying here, I'm dead."
In the past 18 months, 17 states set up electronic prescription databases to track doctors who prescribe, and patients who receive, Schedule II drugs. Six more states are considering similar systems. Meanwhile, legislators in West Virginia are considering a ban of all the drugs that contain oxycodone. One Pennsylvania legislator has introduced a bill that would move OxyContin from Schedule II to Schedule I, a category that includes mescaline, heroin and other drugs considered to have no medical purpose.
"The entire idea of [the Virginia tracking law and others like it] is to go after people who are willingly and intentionally breaking the law," says Tim Murtaugh, spokesman for the Virginia attorney general's office. "It's clearly growing as a problem, and we believe that it's the commonwealth's responsibility to address it."
But doctors have blanched at the sweeping changes and proposed bans, and their panic has only increased in the wake of cases like that of Dudley Hall, a Bridgeport, Conn., doctor charged July 17, 2001, with 36 counts of over-prescribing. Sure, they argue, Dr. Hall, who prescribed more OxyContin that any other doctor in his state, (earning the title Dr. Feelgood), deserves to be prosecuted. But Hall was busted by officers posing as patients, and doctors fear that undercover operations will become the norm. The new laws, say doctors, even if they didn't lead directly to Hall's arrest, make police especially brash, far too confident in their ability to decide which prescriptions are valid or invalid.
Just the specter of law enforcement meddling in medicine has been enough to cause physicians to drop needy patients, says Michael Brennan, a pain management doctor who manages a private pain clinic in Fairfield, Conn., a wealthy town only a few miles from where Hall was charged.
"Doctors are like prairie dogs," he says. "One or two will stick their heads up, but as soon as something bad happens to them, they all go underground."
The American Medical Association stresses that there's no data showing a major shift in prescribing practices or referrals. And says Dr. Herman Abromowitz, a member of the AMA's board of trustees, "The AMA is trying to reassure doctors that if they're doing the right thing -- if they're prescribing appropriately -- they shouldn't have anything to fear."
But Brennan argues that the increased presence of law enforcement is hard to dismiss. In fact, he says that he's still reeling from an unexpected visit by the DEA around Thanksgiving. Though he's strict about whom he'll write prescriptions for -- he regularly meets with family members to ensure that abuse isn't occurring -- he says that "every time I see a big blue Suburban come by my office, I'm like 'Oh man, I hope they're not coming for me.'"
Many doctors looking for creative ways to deal with new layers of regulations have found loopholes that can result in further suffering for the patients they are willing to keep. Many physicians, for instance, are continuing to prescribe pain medication, but are cutting dosages. For sufferers of chronic pain, who often require increased dosages over time because of increased tolerance to their medications, this is a move that promises less relief in the face of increasing pain.
Dabrowski, for one, says she's suffering unnecessarily because of this practice. Dale Denton of Franklinton, La., says it has been disastrous for his 79-year-old father, who suffers from an advanced form of melanoma. Four months ago, his father's doctor cut his father's daily medication intake in half -- from two 40-mg tablets of OxyContin to two 20-mg pills. "Then [the doctor] cut him down to morphine, which is making him sick," says Denton, whose father is on Medicaid. "He told her about it but she wouldn't give him enough. She said there's too many dopeheads. I said, 'They're not going to get it,' and she said, 'Damn right, because I'm not giving it to him.'"
In fact, most users of OxyContin and other strong pain medications are not addicts, says Carr at Tufts University. "For every one case of a robbed pharmacy to get an opioid, there are probably 100 people who are undertreated or appropriately treated."
But, adds David Joranson, director of the pain and policy studies group at the University of Wisconsin Medical School, "America is a country where the treatment of pain is governed by how we perceive the drug-abuse problem." As a result, he adds, "there's a multiplier effect." Laws aimed at the minority are having an enormous effect on the majority, most of whom feel they can barely survive without their pills.
Denton is angry that his father is suffering from unnecessary pain, but he is even more furious that his father's suffering is making the end of his life intolerable. "When he was on Oxy, he could he enjoy his life a little," Denton says. "He was comfortable; he was able to go in the yard a bit. But since they took him off, he's been down in bed and he ain't been back up."
Doctors in many areas also are shuffling pain patients off their rosters. Rather than deal with the increased scrutiny, they're referring patients to pain specialists, many of whom are already overwhelmed. Michael Brennan is dealing with the issue first-hand. About 90 percent of his practice's 800 patients suffer from non-cancer chronic pain and Brennan says that he's in danger of burning out -- in large part because he's receiving a substantial uptick in referrals.
"We have little old ladies on 10 milligrams of OxyContin referred to us because their doctor doesn't want to prescribe it," Brennan says. "People aren't willing to take the risk for their patients. Some will put their patients on non-narcotic pain relievers -- which puts patients at risk -- and others ultimately just say, 'Hey, let's send them to the pain doctor.'"
John Schoos, 45, is a retired banker who used to fill his prescription for the opioid Levo-Dromoran at the CVS near his home in Hawthorne, N.Y. Now, to calm the constant pain resulting from nerve damage suffered during treatment of testicular cancer and hip surgery, Schoos has to go to Memorial Sloane Kettering Hospital in Manhattan, an hour's drive away. And even there, he says, there's strong prejudice against pain medication.
"One of my family friends is a doctor at Memorial, a surgeon," he says. "He knows that I've been on this drug for a long time so one night, he asks me at a party, 'Hey, are you off the pills yet?'"
"And I was like, Jesus, if he doesn't get it, the fact that I need these pills to get up in the morning, imagine how many others don't understand."
Once patients get their drugs, they are frequently limited to a maximum of one month's supply. That means they run out faster, and then, because pharmacies can no longer carry large supplies, they struggle to find a pharmacy to refill their prescriptions. A further limitation, which is another direct result of the painkiller crackdown, is that many patients are being forced by their doctors to sign contracts in which they promise never to visit another doctor or pharmacy for prescriptions. So, if the pharmacy specified in the agreement doesn't have what the patient needs, the patient has to decide what is worse: to violate a contract by going to another pharmacy? Or to forgo medication that makes life livable?
Sara Patterson was forced to make such a choice just last month. Her daughter Holly, who is 7, suffers from damaged nerves and a degenerative spinal disorder. Essentially, says Patterson, "her body doesn't regulate the pressure of her spinal fluid, and the fluid puts pressure on her damaged nerves, which causes the pain."
Holly's form of excruciating agony comes and goes. She can spend three or four months in unrelenting, paralyzing pain, and then enjoy a month of relative comfort, only to have the pain strike suddenly once again. Last month, when the pain hit, Patterson called her daughter's pain clinic -- a two-hour drive from her Central Florida home -- to get a prescription for Holly. The doctors didn't answer.
In a panic, Patterson went to Holly's local pediatrician, who immediately offered to prescribe medication. "But I said no, you can't do that," Patterson says. "I told her I had signed a contract that prohibited me from buying medication from another doctor. I was afraid of getting in trouble." Instead, Holly endured another day without relief before getting the right medication from the "legal" source.
Meanwhile, Patterson says she fears that Holly will commit suicide.
"Every birthday, she blows out her candles and wishes for the pain to go away," Patterson says, her voice quivering. "She constantly says that she doesn't want to live. She just asked me 15 minutes ago if she could go ahead and kill herself. Right now she doesn't understand what it means to terminate her life. But what happens when she gets older? She might actually succeed. Our time is running out."
The DEA justifies its steps to limit access to opioids with figures that blame the diversion of OxyContin from patients to addicts for an estimated 300 deaths in 31 states over the past two years. As recently as March 22, DEA chief Asa Hutchison called for more prescription-drug tracking to help law enforcement nab addicts and doctors.
To be fair, Hutchison also has stressed that increased enforcement should not affect pain patients, and the DEA's OxyContin Action Plan states that "these actions are not intended to impact on the availability of legitimate drug products for medical use."
But experts question the sincerity of law enforcement's dedication to those who truly need strong pain medication. There have been no mitigating laws passed in the interest of patients. Joranson, the pain policy expert, argues that in many states new prescription laws amount to simple politics: "Politicians need to be seen as doing something about drugs," he says. And others fear that Hutchison's stated attempt to protect legitimate prescribing will go unheeded. With press attention focused on doctor busts and new laws that extend police powers, authorities may not curtail their efforts, but expand them.
"While the DEA has strived to be sensitive in their central office to pain medications, I question whether that commitment has trickled down to the field," says John Giglio, one of several pain-management advocates who met with Hutchison last fall to plead the pain patients' case. "I also question whether the people in the office of diversion control have really gotten that message, much less gotten the additional training that they need to treat doctors and patients fairly."
Some patients are fighting back. Mike Schrader, for example, had his prescription switched from OxyContin to methadone a month ago. At first, the former X-ray technologist didn't mind. The methadone alleviated some of the pain he suffers in his hips and back -- the result of 14 separate surgeries -- and he was willing to give it a try. But eventually he discovered that the new pills were weaker than expected.
"My pain level before OxyContin was an 8 out of 10," he says. "With OxyContin it was on a 4-5 level. Now I'm back up around a 6."
Schrader figures that there's no reason to sit back and take the pain. He says that for as long as the methadone fails him, he'll keep asking his doctor for the same level of relief he received with OxyContin. "I'm not going to let him force me to suffer just because he's scared to write the prescription," he says.
Few victims of chronic pain have Schrader's energy or clarity of mind to protest undertreatment, so pain advocates are trying to back them up -- to little avail. "We are an opiophobic nation," says Barbara Coombs Lee, president of the Compassion in Dying Federation, a nonprofit that is suing U.S. Attorney General John Ashcroft for trying to overturn Oregon's physician-assisted suicide law. "We have a craziness about this issue and the effect is that it harms patients in pain and those at the end of their life."
Adds Murray, "If [OxyContin] was taken off the market right now, it would not hurt the drug addicts," she adds. "It would only hurt the people who need it. The addicts will get another drug. It's gonna be us that pays."