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Http://www.time.com/time/printout/0,8816,2015763,00.html

Monday, Sep. 13, 2010
The New Drug Crisis: Addiction
by Prescription
By Jeffrey Kluger

Update Appended: Sept. 17, 2010
It's not easy to find a mother who would look back fondly on the time her son had cancer. But Penny (not her real name) does. Penny lives in Boston, and her son got sick when he was just 13. He struggled with the disease for several years — through the battery of tests and the horror of the diagnosis and, worst of all, through the pain that came from the treatment. For that last one, at least, there was help — Oxycontin, a time-released opioid that works for up to 12 hours. It did the job, and The brain loves Oxycontin — the way the drug lights up the limbic system, with cascading effects through the ventral striatum, midbrain, amygdala, orbitofrontal cortex and prefrontal cortex, leaving pure pleasure in its wake. What the brain loves, it learns to crave. That's especially so when the alternative is the cruel pain of cancer therapy. By the time Penny's son was 17, his cancer was licked — but his taste for Oxy wasn't. When his doctor quit prescribing him the stuff, the boy found the next best — or next available — thing: heroin. Penny soon began spending her Monday nights at meetings of the support group Learn to Cope, a Boston-based organization that counsels families of addicts, particularly those hooked on opioids or heroin. (See the top 10 medical breakthroughs of 2009.) "Penny told the group that she actually misses her son's cancer," says Joanne Peterson, the founder of Learn to Cope. "When he had that, everyone was around. When he had that, he had support." Penny and her son are not unique. Humans have never lacked for ways to get wasted. The natural world is full of intoxicating leaves and fruits and fungi, and for centuries, science has added to the pharmacopoeia. In the past two decades, that's been especially true. As the medical community has become more attentive to acute and chronic pain, a bounty of new drugs has rolled off Big Pharma's There was fentanyl, a synthetic opioid around since the 1960s that went into wide use as a treatment for cancer pain in the 1990s. That was followed by Oxycodone, a short-acting drug for more routine pain, and after that came Oxycontin, a 12-hour formulation of the same powerful pill. Finally came hydrocodone, sold under numerous brand names, including Vicodin. Essentially the same opioid mixed with acetaminophen, hydrocodone seemed like health food compared with its chemical cousins, and it has been regulated accordingly. The government considers hydrocodone a Schedule III drug — one with a "moderate or low" risk of dependency, as opposed to Schedule II's, which carry a "severe" risk. Physicians must submit a written prescription for Schedule II drugs; for Schedule III's, they just phone the pharmacy. (Schedule I substances are drugs like heroin that are never prescribed.) For patients, that wealth of choices spelled danger. (See the most common hospital mishaps.) "If someone is dying, addiction isn't a problem," says Dr. Jim Rathmell, chief of the division of pain medicine at Massachusetts General Hospital. "But for prescribers, the distinction between a patient who has three or four weeks to live and one who's 32 and has chronic back pain started to blur." The result has hardly been a surprise. Since 1990, there has been a tenfold increase in prescriptions for opioids in the U.S., according to the Centers for Disease Control and Prevention (CDC). In 2007, 3.7 million people filled 21 million legal prescriptions for opioid painkillers, and 5.2 million people over the age of 12 reported using prescription painkillers nonmedically in the previous month, according to a survey by the Substance Abuse and Mental Health Services Administration (SAMHSA). From 2004 to '08, emergency-room visits for opioid misuse doubled. At the same time, the drugs have become the stuff of pop culture, gaining cachet in the process. The fictitious Dr. House and Nurse Jackie gobble them like gumdrops, as did the decidedly nonfictional Rush Limbaugh and Heath Ledger. And, like Ledger, some users don't make it out alive. In 1990 there were barely 6,000 deaths from accidental drug poisoning in the U.S. By 2007 that number had nearly quintupled, to 27,658. In 15 states and the District of Columbia, unintentional overdoses have, for the first time in modern memory, replaced motor-vehicle incidents as the leading cause of accidental death; and in three more states it's close to a tie. Watch TIME's video "Forget to Take Your Pills? Don't Worry, They'll Call You." Health officials do not tease out which drug is responsible for every death, and it's not always possible. "There may be lots of drugs on board," says Cathy Barber, director of the Injury Control Research Center at the Harvard School of Public Health. "Is it the opioid that caused the death? Or is it the combination of opioid, benzodiazepine and a cocktail the person had?" Still, most experts agree that nothing but the exploding availability of opioids could be behind the exploding rate of death. Contrary to stereotype, the people most at risk in this epidemic are not the usual pill-popping suspects — the dorm rats and users of street drugs. Rather, they're so-called naive users in the 35-to- 64 age group — mostly baby boomers, with their aching bodies and their long romance with pharmaceutical chemistry. "People with pain complaints get a 30-day prescription for Oxycontin, and it's like a little opioid starter kit," says Barber. The Food and Drug Administration (FDA) has, in its dilatory fashion, begun addressing the problem, but it doesn't promise any action before next year — if then. That leaves millions of people continuing to fill prescriptions, tens of thousands per year dying and patients in genuine pain wondering when a needed medication will relieve their suffering — and when it could lead to something worse. (See TIME's special report "How to Live 100 Years.") Unintended Consequences
The U.S.'s opiate jag began, like so many things, with the best of intentions. In the 1990s, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) — the accrediting body for hospitals and other large care facilities — developed new policies to treat pain more proactively, approaching it not just as an unfortunate side effect of illness but as a fifth vital sign, along with temperature, heart rate, respiratory rate and blood pressure. As such, it would have to be routinely assessed and treated as needed. "It was a compassionate change," says Barber. "Patient-advocacy groups pushed hard for it." And, she points out, drug companies did too, since more-aggressive treatment of pain meant more more-aggressive prescribing. But the timing was problematic. The new JCAHO policy went into effect in 2000, which was not only about the time the new opioids were hitting the market but also shortly after the Federal Trade Commission began allowing direct-to-consumer drug advertising. When market, mission and product converge this way, there's little question what will happen. And before long, patients were not only being offered easy access to drugs but were actually having the medications pushed on them. No tooth extraction was complete without a 30-day prescription for Vicodin. No ambulatory surgery ended without a trip to the hospital pharmacy to pick up some Oxy. Worse, people with chronic pain were getting prescriptions that could be renewed again and again. (Read "Curbing Drug-Company Abuses: Are Fines Enough?") "For me, it started with lower-back pain," says Jason (not his real name), a carpenter in his late 50s. Jason is a 90-day inpatient at the Hanley Center, a residential addiction facility in West Palm Beach, Fla. "I went to my doctor, and he prescribed Oxycontin. After a little while, I was finishing a one- month prescription in three weeks, then in two. I started complaining of more pain than I had so I could get more Oxy, and finally I started buying it on the street. In a pharmacy, I paid $8 for 160 pills. On the street, I was paying $25 each." Jason's demographic profile is typical of Hanley's — older, whiter and generally wealthier than addicts of previous generations. And while some people do wind up buying on the street, many never need to, thanks to the gray market that has sprouted up around opioid sales. As long as the drugs are legal and real M.D.s are prescribing them, it's a simple matter to hang out a shingle and call yourself a pain clinic. Pay-to-play patients are given prescriptions based on little more than their word that they're in pain — sometimes backed up by self-evidently altered MRIs. Says Evelyn (another pseudonym, and another baby boomer at Hanley), "When my physician refused to prescribe me more pills, he sent me to a clinic. The doctor there didn't even ask me my name at first. He wrote me a prescription while he was on the phone dealing with some court case he was involved in. When you're well dressed and you have insurance, they don't think of you as an addict." Read "Study Links Antidepressant Use and Miscarriage." Florida is lousy with such pain-clinic pill mills, in part because of extremely loose oversight of the people operating them. Until June, when Governor Charlie Crist signed a new law cracking down on the operations, there was nothing to prevent felons from opening a clinic and hiring doctors to write the prescriptions. Indeed, on the national ranking of practitioners dispensing Oxycodone, every doc in the top 50 has a Sunshine State address. "I've taken to calling the problem 'pharmageddon,'" says Dr. Barbara Krantz, Hanley's CEO and medical director. "There are seven deaths per day in Florida from prescription-drug overdoses." The state has also become a hub for opioid traffickers in the Southeast. (Read "Difficulties in Determining a Drug Overdose Death.") What worries Krantz and other substance-abuse professionals is that an addiction scourge that is, for now, hitting the boomer demographic hardest won't stay there and instead will gather greater strength in the under-25 cohort. It's not just young cancer patients given a legal taste of Oxy who are in danger in this group; it's everyone. "A parent comes home from the dentist with 30 doses of Oxycontin and only takes a few," says Barber. "Then the pills are stored in the medicine chest, where This is leading to a rise in the incidence of what's known as skittling, a social phenomenon with deadly consequences. "Kids steal from their parents' medicine chests, go to a party and dump everything into a bowl at the door," says Juan Harris, a Hanley drug counselor. "Anyone who comes Killing the Buzz
For kids, education programs in schools help a little, at least in terms of informing them of the risks associated with drugs. But such a rearguard action goes just so far, and a longer-term solution will come only when the government increases its control over the legal dispensation of the most popular pills. The first step would be better surveillance and tracking. An alphabet soup of agencies — from the FDA to the CDC to SAMHSA to the National Institute of Drug Abuse — all have a hand in monitoring prescription meds, but no single one is in charge. "You need Congress choosing an agency and saying, 'This is your baby,'" says Barber. In early 2009, the FDA announced that it was initiating a "risk-evaluation and mitigation strategy," contacting the opioid manufacturers and requiring them to participate in a study of how their meds can continue to be made available while at the same time being better controlled. The regulations the FDA is empowered to issue include requiring manufacturers to provide better information to patients and doctors, requiring doctors to meet certain educational criteria before writing opioid prescriptions and limiting the number of docs and pharmacies allowed to prescribe or dispense the drugs. (See "The Year in Health 2009: From A to Z.") "And with all that," warns Dr. John Jenkins, director of the FDA's Office of New Drugs, "we do still have to make sure patients have access to drugs they need." Any regulations the FDA does impose won't be announced until 2011 at the earliest and could take a year or more to roll out. Other solutions don't face the same regulatory maze. The U.S. Drug Enforcement Administration recently announced a straightforward idea to reduce misuse: a drug take-back day on Sept. 25, 2010, when patients can safely dispose of unwanted prescription drugs at 3,400 government-sponsored sites around the country. An electronic database of all pharmacies across the country could also help catch patients and doctors who are gaming the system, particularly those who hopscotch across state lines. Doctors need to be less cavalier about prescribing drugs and stingier with the amount they do allow. They could also do a better job of assessing patients for addictive histories and requiring urine tests if they suspect a problem. If the patients don't want to comply, they don't have to — but they Insurers — the bad guys in so many policy debates — can do a lot of good, keeping better track of the number and types of controlled substances policyholders are receiving. Big Pharma must help as well, and that means climbing down off the opioid gravy train and working harder to develop more nonaddictive painkillers — even if it means fewer sales and lower profits. At least one company, New Jersey–based King Pharmaceuticals, is seeking a solution. According to a recent review article in the journal Drugs, the company is experimenting with abuse-deterrents built directly into pills. One technique involves including pellets coated with a chemical called naltrexone — which neutralizes the effects of opioids — in the pill. The pellets remain intact and pass through the body if the drug is taken as intended. If the pill is crushed, however — a trick addicts use to produce a faster, more powerful kick — the naltrexone is released, killing the high. Until then, it's up to responsible doctors and cautious patients to keep the epidemic in check. That, certainly, is not easy. "When drug addicts or alcoholics ask us if they can ever use substances in moderation, we tell them no," says Krantz. "Once your brain becomes a pickle, it can't go back to being a cucumber." Too many Americans are pickled already. The time to help them — and protect This is an updated version of a story that originally appeared in the Sept. 13, 2010, issue of TIME. Click to Print
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