Aug 28, 2001 (Cox News Service) - WEST PALM BEACH, Fla. _ In quaint detective novels of the early 1900s, the sleuth's nose twitched at the "scent of bitter almond," the lingering signature of deadly arsenic, a telltale clue that something was amiss: Perhaps there's more to this than meets the eye.
In a sterile laboratory 90 miles north of West Palm Beach, during the summer of 2000, immunoassay and chromatography instruments _ 21st Century sleuth's noses _ began detecting another deadly signature. As blood samples from newly dead people were fed into spectrum analyzers, a distinct pattern of ions flashed repeatedly on display screens, its vertical spikes matching the components of one compound: oxycodone hydrochloride.
Oxycodone had been around for decades as Percocet, Percodan, Tylox and other opium-based painkillers, taken by millions of people for post-surgical pain, broken bones, arthritis, migraines and hurting backs. A slow-release form called OxyContin, made in higher doses to relieve severe pain, had been in use since 1995. So oxycodone and its chemical cousin, hydrocodone, were common enough; they even showed up occasionally in autopsy reports.
But to Linda Sullivan, toxicology supervisor for Wuesthoff Reference Laboratories, something was odd in the results being detected by her machines.
"We've gone through waves of different drugs," Sullivan said. "We've had a heroin epidemic the last three or four years, and we still get that _ it hasn't gone away. But this one (oxycodone) kind of came up very suddenly. We started seeing a definite increase, and we were seeing it in higher concentrations."
Other things that stood out:
"Rather than the typical profile of a cancer patient, now it was younger individuals," Sullivan recalled. "It's always unusual when you start seeing 21, 22, 23-year-olds on opiates used for pain management _ that's not a typical scenario. On OD (overdose) cases, it just wasn't the typical level you see in someone taking a prescription for back pain."
The Melbourne lab analyzes samples for half of the 26 medical examiner offices in the state, including Palm Beach, Martin, St. Lucie and Okeechobee. It alerted the Florida Medical Examiners Association and suggested its members start keeping separate reports on deaths involving oxycodone and hydrocodone.
"You couldn't ignore the fact that something was going on," Sullivan said.
The something was simple, in hindsight: Word had spread that you could get an amazing rush by crushing OxyContin tablets, releasing their 10, 20, 40 and 80 milligram charges of oxycodone and inhaling or injecting the residue. A "full-body orgasm," one addict described it.
As the world now knows, OxyContin has two faces: the miracle drug that lets suffering people sleep, work and reclaim pain-drowned parts of their lives; and the demon that makes people crave it, steal it, steal to get it and recklessly pump it into their bodies for the momentary ecstasy that, for some, turns out to be death in disguise.
In the summer of 2001, this is what's going on with OxyContin and its troubled narcotic family:
_ Oxycodone has been a factor in at least 350-400 deaths nationwide, either as the main cause or mixed with alcohol or other drugs, according to reports compiled by investigator Gregory Wood for the federal Drug Enforcement Administration. Florida leads the pack with 156, a distinction that could be due, in part, to the medical examiners' record-keeping efforts.
_ Fifty-eight bodies autopsied by Palm Beach County's Medical Examiner last year had oxycodone in them, usually along with other drugs. Through June of this year, Medical Examiner Lisa Flannagan has determined oxycodone was the primary cause of death in 33 autopsies, and the drug was found in seven others. The number is destined to go up as delayed toxicology reports come in for June, July and August.
_ At the Hanley-Hazelden Center in West Palm Beach, 85-90 percent of the opiate-addicted patients who checked in during the last nine months said they were abusing OxyContin.
_ At least 700 OxyContin pharmacy thefts have occurred nationwide during the past 18 months, according to the DEA's Office of Diversion Control. Among the leaders, Pennsylvania reported 90, Florida 82, Ohio 74 and Kentucky 69. To ward off robbers, addicts and prescription fakers, some pharmacists have stopped carrying the drug or keep only small amounts for known customers and post "No Oxy" signs in windows.
_ In July, St. Lucie County investigators rounded up 32 people on prescription fraud charges, 21 of them involving oxycodone; Belle Glade police charged a Clewiston nurse with 149 counts of forging prescriptions for more than 6,400 hydrocodone tablets plus numerous other medications; a Palm Beach County grand jury indicted Jupiter Dr. Denis Deonarine on a murder charge related to a patient's OxyContin overdose death; and a federal grand jury in Charlotte indicted 10 people suspected of illegally selling 50,000 OxyContin pills across Virginia, West Virginia and the Carolinas.
_ More than a dozen lawsuits have been filed against Purdue Pharma, the maker of OxyContin, including a $5.2 billion damage claim by Virginia residents who say they got hooked on the drug while taking it as prescribed for chronic pain. Two suits are by families of young men who died by overdose in Palm Beach County.
_ The Health Care District halted its insurance coverage of OxyContin in January, affecting about 100 residents. And in July, the state Medicaid program limited the number of pills its beneficiaries could get each month.
Purdue has launched a nationwide anti-abuse campaign, providing tamper-proof prescription pads to doctors, grants to local drug education programs and speakers for community meetings. The company, based in Stamford, Conn., says it's reformulating OxyContin to include a chemical that would block the drug's effect if the pills are crushed, but the product won't be available for three to five years. Drug abuse critics say Purdue knew other companies had used opiate-blocking chemicals in their products and should have foreseen the need in OxyContin.
Most significant of all, the ease and magnitude of OxyContin abuse has revived the nearly dormant debate over whether opiates should be prescribed for any but the most severe pain. It has also drawn new attention to relationships between doctors who advocate using such drugs and the companies that make billions from selling them.
Doctors on both sides say they respect the power of opium-based medications, which they call opioids, and don't want to see them denied to patients who truly need their relief. But six states, including Florida, have already restricted the drug's distribution to Medicaid patients, and further tightening appears inevitable until the wave of abuse, robberies and overdoses subsides.
Last month, the Palm Beach Medical Society put on a seminar for doctors and nurses at Good Samaritan Medical Center. The speakers were Dr. Alan Spanos, a professor of pain management at the University of North Carolina who also operates a private pain clinic, and Wilbur Corbitt, head of DEA's drug diversion program in South Florida.
Expenses for the speakers, the soft drinks and boxed dinners were provided by Purdue Pharma. Drug companies recruit cadres of doctors, like Spanos, who endorse their products to speak at such meetings.
Spanos argued powerfully for the use of OxyContin and other opioids _ don't use the negative term "narcotic," he urged _ as legitimate, necessary and humane treatment for chronic pain, as well as specific and intractable pain such as that experienced by end-stage cancer patients.
Opioids should be the first resort for pain relief, he said, not the last _ a position opposed by other pain specialists. Nonsteroidal anti-inflammatory drugs, such as aspirin and ibuprofen, contribute to more than 16,500 deaths a year, he said, and that dwarfs any number of oxycodone-related deaths.
Spanos offered a key to the furor over opium-based drugs with this quote from the American Academy of Pain Medicine: "The use of opioids for the relief of chronic pain is a legitimate medical practice."
The AAPM claims 1,200 members, most of them anesthesiologists, neurologists, neurosurgeons and rehabilitation specialists. Its online directory also lists more than 40 corporate members, employees of pharmaceutical and medical equipment companies who don't vote but who serve on advisory committees and whose employers underwrite expenses for academy meetings and publications.
The phrase quoted by Spanos and other advocates is in a 1996 set of guidelines issued by the AAPM and the American Pain Society, titled "The Use of Opioids for the Treatment of Chronic Pain." The full text of the "consensus statement" can be found on AAPM's website at www.painmed.org.
The statement, a seminal document in the trend toward more liberal use of opiates, was adopted just as Purdue Pharma was beginning the marketing push for its new drug, OxyContin.
The guidelines begin with the premise that "there is currently no nationally accepted consensus for the treatment of chronic pain not due to cancer," and progress to the organizations' objective: "for state policies to recognize but not interfere with the medical use of opioids for pain relief."
The guidelines are a clear and persuasive argument for expanding the role of opiates from the limited treatment of acute, intractable pain to the wider and more loosely interpreted world of chronic pain. They emphasize the clinical differences between addiction, physical dependence and tolerance, and say that even addicts experiencing severe pain can take opioids under careful supervision.
The statement was produced by a task force chaired by Dr. J. David Haddox, an anesthesiologist and former president of the AAPM who's now senior medical adviser for Purdue Pharma.
Haddox had been one of Purdue's cadre of speakers since 1986. He left his private practice and teaching position at Emory University in 1999 to work for the company full time. A year into the job, he suddenly found himself the point man for its OxyContin defense and damage control, a role he fills with conviction and arguments honed by constant repetition in recent months.
"Drug abuse has gotten us into this mess, not patients," Haddox said last week. "As a pain physician, I am incensed that people who choose to abuse drugs, and criminals who supply them, are threatening to dictate medical care to patients with legitimate need."
Haddox said he joined Purdue Pharma because it was "the most ethical and one of the most visionary" pharmaceutical firms. "And obviously their primary interest was my primary interest _ treating pain, making sure people have access to appropriate medications."
The opiod guidelines grew out of a series of 11 regional workshops conducted by the University of Wisconsin Pain and Policy Studies Group _ to which Haddox belonged _ for members of state medical licensing boards, the bodies that regulate doctors' practices. He and other pain specialists asked the state boards what could be done to bring regulations into line with the medical profession's changing views on using controlled substances for long-term treatment of other types of pain besides cancer.
"They said, 'We need some guidelines,' " Haddox said.
Two years later, his task force produced the opioid statement, which became the precursor to other guidelines, including those issued by the Federation of State Medical Boards in 1998.
"The point," Haddox said, "was to gather consensus: If you are going to do this, this is how it should be done."
Was it ethical for Haddox, associated with a pharmaceutical maker as one of its cadre of speakers, to guide the formation of a document that would play a key role in promoting the use of products made by the company?
"Academics and scientists are a fractious group," said Kenneth Goodman, director of the University of Miami's bioethics program. "I would find it hard to believe that, if they disagreed with him, they would hold their fire. It would require a conspiracy that's just too over the top to contemplate."
Doctors and pharmacists in other states have said Purdue Pharma salespeople were aggressive in trying to get them to prescribe and sell OxyContin, whose sales have shot up to more than $1 billion a year.
Pennsylvania's Attorney General called on Purdue last week to stop giving doctors promotional pens containing a pullout conversion chart to help them switch patients to OxyContin from less powerful medications such as Darvocet and Tylenol with codeine. Purdue said it had already stopped giving out the pens and other promotional materials to comply with a Federal Drug Administration requirement that they carry a new, more restrictive warning.
"In 26 years, I've never seen a marketing program such as Purdue Pharma conducted for OxyContin in Florida over the last two years," the DEA's Wilbur Corbitt said. "I don't know if it's right or wrong; I do know it sold the product in Florida."
Payments for OxyContin prescriptions by the state's Medicaid program alone more than quadrupled in three years, from $4.5 million in 1998 to $21 million in 2000. The state projects it will spend $30 million on OxyContin this year, despite emergency restrictions limiting patients to 120 pills a month without prior doctor approval.
At West Palm Beach's Hanley-Hazelden Center, where a four-week rehab stay can cost more than $20,000, the first Oxy patient checked in 2 1/2 years ago.
By the end of last year, health services supervisor Renna McGinnis said, practically all _ 85-90 percent _ of the center's opiate-addicted clients said they were using OxyContin, and that they could get the drug easily. It had joined or replaced the usual suspects _ heroin and less potent prescription meds such as Lortab, Percodan and Percocet.
"The majority were addicts who heard about a new pill and wanted to try it," she said. "They went doctor-shopping. Addicts know which doctors to go to."
Recent rehab patients say they're now able to get their drugs, including oxycodone, on the Internet, from a profusion of websites that promise virtually any drug from foreign sources, with or without prescriptions.
"Even kids can do it," McGinnis said. "Click, click, click, put your credit card up there, they'll deliver it to your door."
Local doctors, like their counterparts across the nation, hold strong opinions about the role of opiates in pain treatment and the effects of abuse on legitimate patients' access to such drugs.
"I won't prescribe (OxyContin). I try to stay away from narcotics," said Dr. David Rondon, a West Palm Beach orthopedic surgeon. He said he had to prescribe OxyContin two or three times for patients who had been on the drug for long periods before coming to him for surgery, because they didn't respond to any other medication.
"I had one patient, a 27-year-old woman, who had been on it for three years," he said. "We ran a complete battery of tests . . . and found nothing wrong. I told her, 'You don't need to take this, you need to go into drug rehab.' The pain she was feeling when she didn't take the medication was withdrawal from it."
Drugs as powerful as OxyContin should be used "like an A-bomb," as a last resort, said orthopedic surgeon Dr. Mas Massoumi. When patients have severe pain that doesn't respond to usual treatment, Massoumi said, he prefers sending them to a reputable pain management clinic for diagnosis of underlying causes of pain and a wider range of therapies than the typical doctor's practice can provide.
Dr. Wayne Weidenbaum is a pain specialist at such a clinic, Palm Beach Pain Consultants. He says abuse of OxyContin is a legal issue, not a medical issue, but it has affected treatment.
"We haven't changed what we do," Weidenbaum said. "However, if a patient is suitable for starting on a long-acting pain medication and several choices are equally good, I might pick a drug that doesn't have any negative publicity right now. So it does have an impact."
Before the trend toward acceptance of opiates in the past 10 years, most doctors were reluctant to prescribe them for anything other than post-operative or terminally ill patients for fear of creating addiction and the risk of censure by regulatory agencies. The alarm over OxyContin abuse has raised that fear again.
"OxyContin was my first choice in patients who could tolerate oxycodone and who required long-acting medications," said Dr. Mark Rubenstein, a pain management specialist in West Palm Beach. "But no longer."
Doctors are at risk with every prescription they write, opioid or not, Rubenstein said, because they can't control how patients use either the prescription or the medication. If he suspects a patient is trying to get oxycodone without a physical basis, he tells them it isn't appropriate.
"The ones who are simply seeking medication leave the office and never return," he said.
Pharmacists also have found themselves in the front line of battle, often literally, over OxyContin. The Boston area has had more than 40 holdups of pharmacies by individuals and gangs; last week, masked bandits even invaded a nursing home and held the staff at gunpoint while demanding the drug.
After a WalMart pharmacy robbery in Boca Raton last month, Glades Apothecary posted a "No OxyContin" sign.
"We were getting a lot of prescriptions for OxyContin, and my boss just doesn't think it's safe to carry any more," pharmacist Tommy Greene said. "There are other medications to manage pain, and they'll just have to use them."
Pain specialists and pain sufferers fear the combined effects of all the revelations, reactions, publicity and debate over OxyContin will lead to restrictions on medications that make life _ and death _ bearable for millions.
Hospice of Palm Beach County has more than 500 terminally ill people in its care, and OxyContin accounts for 15 percent of their prescriptions. Some of those patients need staggering amounts to ease their suffering _ as many as 30 of the 80 mg pills per day.
"There is no ceiling on opioids," said Dr. Gail Austin Cooney, medical director. "Some people are very comfortable on very little, and others are on thousands of milligrams a day. The right dose is the one that works.
"What I'm concerned about is throwing the baby out with the bathwater. This is a good drug, and it's been very useful for controlling pain."
Controlling the drugs that control the pain is the dilemma raised by the phenomenon of OxyContin: How to keep it and other opiates from getting to abusers without restricting it for those in need.
Medical ethicist Kenneth Goodman says he's not convinced that desperate people robbing pharmacies is anything more than a problem for law enforcement.
"We should not allow it to be a problem for people in palliative care," Goodman said.
"It's tempest in a teapot, but it's a big teapot, and it will take a while to blow itself out."
