Fighting the 'miracle drug' that turned deadlyJan 14, 2002 | Court TV
Gilbert, West Virginia, a tiny mining town lodged along the Tug Fork river in the heart of the Appalachian Mountains, has, in the last five years, suffered a blight on its population: Nearly four out of 10 young adults has become addicted to OxyContin, one of the strongest painkilling drugs on the market.
The plight of these addicts is no secret locked away in the hardscrabble mountains. In the past few months The Associated Press told readers about 20-year-old Gilbert resident Kristen Rutledge, who injected the drug regularly despite the suicide of her 18-year-old cousin because she couldn't get another fix. A British newspaper took its readers into a meeting of the Gilbert community board, where a retired miner named Danny Layne painfully recalled the state in which his son Brian was found — sitting motionless on his bed with his arms and legs crossed, his neck cold, and fresh track marks in his arm — after overdosing in October 1999. And the New York Times took readers on a "pillhead tour" of the nearby town of Man as an addict named Paula scoured the streets for an early morning fix.
Gilbert and Man may be poster towns for the OxyContin "epidemic," but a rash of addictions afflicts the East Coast, forcing police, prosecutors, and even the drugmaker, to find ways of stemming diversion of the drug to illegal uses.
West Virginia, the state that ranked first in per capita OxyContin prescriptions in 2000, has now set another sort of precedent. In a suit against OxyContin's manufacturer, Stamford, Conn.-based Purdue Pharma, the state charges that the maker defrauded consumers by pushing its $1 billion-dollar-a-year product through "highly coercive and inappropriate tactics," such as marketing the drug as less addictive than others because of its time-release formulation.
"The police were doing the best job they could, but did that stop what was going on? No," says Doug Davis, West Virginia's assistant attorney general. "This [lawsuit] is the avenue we have to do this."
West Virginia's approach is illustrative of the course being set by legislators, states' attorneys and private citizens across the U.S. Faced with a growing abuse problem that threatens to spiral upward, they're coming at it from all sides.
In all, more than 40 civil suits are currently filed against Purdue Pharma, according to the manufacturer. Six states have developed curbs to prevent Medicaid recipients from receiving the drug so easily. Florida and Kentucky have filed criminal charges against the doctors that prescribed fatal doses of the drug. The FDA (news - web sites) has forced the manufacturer to change it's labeling to a "black box" type reserved for the most dangerous and addictive drugs. And many states are considering adopting some sort of prescription database system to track the drug's distribution. But is this enough?
A Miracle Drug Hits the Streets
Five years ago, before it was wedged firmly between Harry Potter (news - web sites) and the recession in the non-Sept. 11 zeitgeist of the country, OxyContin was still considered a miracle drug, the painkiller to end all painkillers. But that was before the drug became known as "hillbilly heroin." That was before it spurred a crime wave, with addicts robbing pharmacies en masse in Boston, Kentucky and Maine. And that was before people like Michael Labzda, a 21-year old student and aspiring horticulturist, began to die.
Labzda, who lived in Jupiter, Fla., was an avid body-boarder and fisherman. After graduating high school in 1998, he moved on to Palm Beach Community College, where he was also helping out in the horticulture department.
Labzda had a problem, however: He abused OxyContin. Though the drug was meant to relieve pain, people like Labzda realized quickly that it could be converted into a recreational drug in one simple step. By smashing the tablet, the time-release mechanism was defeated and the drug could be shunted all at once into the blood by snorting or injecting it, providing a rush of euphoria rivaling that of even heroin.
Like heroin, OxyContin is an opiate capable of causing physical dependence. Its active ingredient, oxycodone, is also found in other painkillers such as Tylox and Percocet, but in much smaller amounts — whereas these drugs typically contain 5 to 10 mg of oxycodone, OxyContin tablets can contain as much as 80 mg. If abused, such high doses can be fatal.
It was fatal for Michael Labzda. On Feb. 8, 2001, he overdosed.
Medical examiners found OxyContin, alcohol, and another prescription drug in Labzda's blood, and Florida authorities quickly pinned responsibility on Dennis Deonarine, 56, a Jupiter doctor they said supplied Labzda. They charged the doctor with racketeering, drug trafficking and felony murder.
Deonarine wasn't the first physician to be charged in connection with an OxyContin overdose death. A California doctor pleaded guilty to manslaughter in 1999 for charges related to three deaths, and the manslaughter trial of another Florida doctor, James Graves, begins Monday.
But Deonarine's case is unique because the doctor, who is also linked to three other overdose deaths, will be the first to face first-degree murder charges, and could be the first doctor ever to receive the death penalty for his prescriptions.
Attacking from All Sides
Doctors like Deonarine are increasingly being targeted for their role in the OxyContin pipeline, and not only when their patients die. Several doctors across the country have been targeted for illegally supplying patients with the drug. Just one unscrupulous doctor can flood a community with illegally prescribed OxyContin.
"We are dealing with the pharmaceutical equivalent of the atomic bomb," Labzda family's attorney, Jack Scarola, told a local paper. "From the outset everyone involved in the chain of distribution of this drug has failed to recognize its potency and its potential for abuse."
But doctors aren't the only concern. Patients often obtain access to the drug through loopholes in the system. To screen potential users, six states so far — Florida, Maine, Vermont, West Virginia, Ohio and South Carolina — have created a sort of secondary review that makes it more difficult for Medicaid and Medicare patients to get OxyContin. Also, eight states, including Connecticut, New Jersey and Florida, are considering a prescription monitoring program to catch patients who "doctor shop" to obtain multiple prescriptions of the drug.
This multi-pronged attack is unprecedented, says Andrew Popper, professor of law at American University Law School in Washington D.C., because the publicity given to OxyContin has been greater than that given any other prescription drug that has been abused.
"This is a problem that doesn't get solved by one damages case, a class action suit, or by one state resolving it's Medicare costs," says Popper. "It's going to be solved by public awareness."
The West Virginia approach, in particular, is being closely watched by lawyers in other states. If the state's civil suit against Purdue Pharma is successful, it could create a bandwagon like the one states joined en masse against the tobacco industry a few years back.
"One multi-million dollar case ripples through the industry in about 12 hours whereas changing a label through the FDA can take up to five years," says Popper.
Chilton Varner, a lawyer with the firm King and Spalding who is representing Purdue Pharma in the suits, estimates that the company is currently faced with about 45 cases, but says that number is "a moving target."
"As pharmaceutical mass tort litigation goes, 40 cases is not a particularly large group of cases," she said. "With [the diet drug] Phen Phen you had well over a thousand cases, and there were literally several thousands of breast implant cases brought."
Also, many of the individual claims have been dismissed. "In some of the lawsuits, the plaintiffs openly state that they obtained the drugs illegally or have a prior drug abuse problem," says Varner. "We believe those claims are without merit."
Popper, an expert on tort, or damages, law, says that the key to the civil suits is how much Purdue Pharma knew about the drug's addictive qualities, and when.
He says that it's unlikely that Purdue Pharma knew how addictive OxyContin could be when it was first released. The central issue, therefore, will be whether the company continued to sell the product without additional warning after it realized the drug was addictive and being abused to negative effect.
Another question being raised is whether Purdue Pharma was overly aggressive in marketing the drug. According to the suit, which also names Chicago-based drug distributor Abbott Laboratories and two doctors who prescribed the drug, Purdue Pharma marketed OxyContin as less addictive because of its time-release formula, and pushed the drug for all levels of pain severity, despite being aware of the drug's addictive properties.
"It's amazing," says Steve Annand, an attorney with Cohen, Milstein, Hausfeld & Toll, which is handling the suit for the state. "The things that they've done were beyond any reasonable marketing for narcotics."
Annand says the company trained thousands of doctors in all-expenses-paid vacations to increase prescriptions, and created videos with patient testimonials which they encouraged doctors to show to their patients.
Purdue Pharma has denied marketing OxyContin directly to consumers, but the company was reprimanded in 2000 for pushing OxyContin for arthritis pain, and it even put out a big band CD called "Swing Is Alive," whose cover showed two dancing seniors above the slogan "Swing in the right direction with Oxycontin."
Turning to Legislation
Maine is one state with an eye on the West Virginia suit. "It's under discussion in our office," says assistant attorney general and drug prosecution coordinator James Cameron. "We're carefully looking at the basis for those suits."
Maine has taken a different approach to the problem of diversion, putting the squeeze on the drug dealers instead of the doctors and drugmakers. In that state, new legislation making possession of a large number of OxyContin tablets a felony (it used to be a misdemeanor) could halt pushers from supplying the tablets, each of which can yield more than $80 in profit each.
Maine's new legislation also takes into account the potency of the tablet being sold, rather than just the number or weight, which can lead to lighter sentences even when the amount of drug in question is large.
"What we've done in Maine was what could be done quickly, and with relatively little expense to state government," said Cameron, assistant attorney general and drug prosecution coordinator.
In Pennsylvania, state representatives have said they will propose legislation that would tack an additional five years onto the potential sentence of anyone convicted of dealing or trafficking in OxyContin.
Washington has been slower to act than the states — whose health care budgets have borne the brunt of the drug's expense and whose municipalities have weathered the crime that addiction has created — but of late the FDA and DEA have taken a firm stance in favor of changing the way OxyContin is doled out in the country.
The FDA, which has direct regulatory control over OxyContin, was instrumental in boosting the warning label on the package to "black label" status, which is the most serious warning that can be used on a drug.
The DEA, which has no regulatory power over Purdue Pharma, has put pressure on the drugmaker to reduce the diversion of its product. Its efforts have ranged from encouraging Purdue Pharma to cut back production to developing a form of the drug that's not so easy to abuse. DEA head Asa Hutchinson said in a December 11 statement to Congress that "The disproportionate abuse of OxyContin is due, in part, to aggressive marketing and promotion of OxyContin by Purdue Pharma, who represented the product as having a lower abuse potential than other opiate pain relievers."
What Is Purdue Pharma Doing?
The maker of OxyContin has come under fire, not only for its aggressive marketing, but for failing to keep tabs on skyrocketing sales in areas where addiction is high.
"It took everybody by surprise," said J. David Haddox, senior medical director for health policy with the company. "But we have no credible information that people who take the drug as directed have become addicted." The more than 40 suits now facing Purdue Pharma allege that the company did have such information.
Since OxyContin was identified as a problem in 2000, the company says it started a number of programs aimed at reducing abuse.
"No other pharmaceutical company has ever done as much or as quickly in response to abuse and diversion of a product as Purdue Pharma has," said spokesperson Tim Bannon.
The company's efforts have included discontinuing the most powerful pill, a 160mg form of the drug; stamping pills from Mexico and Canada to help authorities trace illicit supplies; passing out tamper-proof prescription pads to doctors; and instituting educational programs aimed at doctors as well as potential abusers, with a particular focus in the Appalachian region.
The holy grail of the company's anti-abuse efforts is an abuse-resistant form of their drug now in clinical trials, that Haddox says could come to market as early as 2003.
But FDA approval is a long and tortuous process, and while Purdue waits to roll out its new product, the old one remains on the streets. It's easy to abuse, heavily addictive like all other opiates, and more users get hooked every day. About 1.6 million Americans used prescription-type pain relievers for non-medical reasons for the first time in 1998, and the number of oxycodone emergency cases increased nearly 36 percent in a single year, from 3,369 in January to June 1999 to 5,261 in January to June 2000.
The Flip Side
But can the efforts to restrict access to OxyContin go too far? In danger of being forgotten in the OxyContin epidemic are those who depend on the drug for legitimate pain relief — the terminally ill cancer patients and chronic pain sufferers.
Some of the more extreme regulations proposed have included restricting access to dying patients and allowing only qualified "pain specialists" to prescribe the drug.
"It would be a tragedy if we could only use these drugs on people who were dying," says June Dahl, founder and executive director of the American Association of Cancer Pain Initiatives. "We spent so much time getting to the point where physicians were comfortable prescribing these drugs that this particular attention to this one drug could undo all of the efforts that have been made over the past 15 years."
But that risk is not the central concern of West Virginia's attorney general, Doug Davis. He is worried about the town of Pulaski, where the sheriff estimates that 90 percent of crimes being committed are OxyContin related. Davis is worried about Tazwell, where 12 pharmacies were robbed for the drug in a one-year period. And he's worried that the number of children placed in foster care has tripled over the last four years in Lee County, primarily because of OxyContin abuse.
"We're just trying to get a handle on this problem now," Davis said. "It's crippling West Virginia."