STATS ARTICLES 2007
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The Ayatollah of Hyperbollah, Geraldo Rivera, had a good righteous rant over the manufacturer of OxyContin, which was fined for misbranding the slow-release opioid painkiller last week in West Virginia. On the May 13 edition of Geraldo at large, Rivera opened the show by describing Purdue Pharma as “nothing but a lowdown and dirty drug pusher.” And just in case you missed the point, he followed up with, “They are the most insidious drug pushers, forcing their addictive junk on millions of unsuspecting victims, with the same disregard for their health and wellbeing as any demon doper. But the vultures I'm talking about don't live here. They're from places like this, and peddle their poison from the comfort of the boardroom, using corporate camouflage to cover their treachery and greed.” One could keep quoting Rivera in a similar vein – “white-collar criminals who infested society with their drug” being a particularly good example – but the question would still be the same: is this crusading rhetoric mere posturing or derived from actual reporting? Opioid painkillers are one such option, and the introduction of the controlled release OxyContin, which lasted 12 hours, was seen as a major breakthrough for pain treatment as it did away with the need for pain sufferers to take medication every few hours. As Katz notes, Oxycodone CR (the active ingredient of OxyContin), “was approved by the [Food and Drug Administration] in 1995 based on evidence that suggested the abuse liability of the product would be no greater than that of similar controlled-release analgesics… The widespread subsequent abuse of oxycodone was not predicted from the data available to the FDA.” Indeed, for a number of years after its release, it did not appear that OxyContin was being abused in the way that regular oxycodone was, which was available prior to 1995 in much smaller doses through such medications as Percocet and Percodan. The number of times OxyContin was recorded in an emergency room visit due to abuse was zero in 1996, four in 1997, 527 in 1998, and 1,178 in 1999. There was an enormous jump from 2,772 mentions in 2000 to 14,078 in 2002. (Data from DAWN – the Drug Abuse Warning Network) Based on autopsy reports from 23 states over the period 1999 to 2001, researchers found that the overwhelming majority (98 percent) of people who died from abusing oxycodone had combined it with other illegal narcotics, such as cocaine and heroin. Twelve deaths were attributable to OxyContin alone. The study was funded by the manufacturer of OxyContin, but it was published in the peer-reviewed Journal of Analytical Toxicology. "Scores died as a result of OxyContin abuse and an even greater number of people became addicted," said district attorney John Brownlee in West Virginia last week; yet the data indicated that the people who were abusing OxyContin were drug addicts to begin with, and that poly-pharmacy – the mixing of several drugs at the same time, sometimes also with alcohol – was responsible for most of the deaths. Purdue Pharma were fined because some of its sales force underplayed the risk of OxyContin abuse to doctors prior to 2001, which is not the same thing. Nor is there evidence that taking OxyContin as prescribed raises the risk of accidental addiction, which is considered very low for opioids by numerous medical authorities. “Purdue's OxyContin never lived up to its hype and never offered a low But this is contradicted by the medical literature, by clinical practice, by the testimony of numerous pain patients, and by the evolving way regulators have dealt with the drug. Opioid medications will not work for everyone, but as Portenoy et al note in their recent study, “Long-term Use of Controlled-release Oxycodone for Noncancer Pain: Results of a 3-year Registry Study,” (the Clinical Journal of Pain, May 2007): “The increasing medical use of CR oxycodone [OxyContin] and other long-acting opioids when pain is continuous or frequently recurrent has resulted from several factors, including the evolving consensus of pain specialists, professional education, professional and public outcry about undertreatment of pain, reassurance about the legitimate medical role of opioid medications by the regulatory and law enforcement communities, and new research that has provided evidence of favorable outcomes associated with opioid therapy of varying durations in many conditions…. The present registry study was designed to evaluate outcomes associated with the long-term use of CR oxycodone in the treatment of noncancer pain. The data address some of the significant issues surrounding this therapy. One of the most important concerns during long-term opioid therapy relates to the potential need for repeated, and ultimately unsustainable, dose increases to maintain benefits. This study provides evidence that the greatest need for opioid titration occurs during the first 3 months for most patients, after which further dose escalation may be gradual and minimal. This stability of dose over time in populations with nonprogressive diseases, and indeed, in cancer patients with indolent or stable disease, has been observed previously. The complex phenomenon of analgesic tolerance does not seem to routinely drive dose escalation during the long-term treatment with opioid drugs. In this study, almost all of the relatively few patients who demonstrated a pattern of repeated dose escalations after month 3 had inadequately managed or escalating pain. The registry data also demonstrate sustained analgesia with CR oxycodone. A decrease in pain was initially seen by the end of month 3, and for the majority of patients, the Average Pain Intensity score remained the same, better, or minimally worse (<3 points) for the remainder of the 3-year study period.” Portenoy, who is Chairman of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York, also noted that “Opioids are potentially abusable drugs and the possibility of misuse, abuse, and even addiction or diversion exists whenever a patient is treated. The risk of these types of adverse outcomes is likely to be higher in varied subgroups of patients, most notably those with a history of drug abuse or addiction.” As Dr. Steven D. Passik, one of the nation’s top experts on pain treatment, explained in the May 2001 issue of the Journal of Pain and Symptom Management: “The problem is not a specific drug, but rather the base rate of addiction in the United States and the increasing availability of this medication. With 6 to 15% of the US population having a drug problem, any highly available opioid will be sought by this proportionately small fraction of the population, which actually represents millions of substance abusers. Because 6- 15% of the US population abuses drugs, the history of pain management is marked by the undertreatment of the other 84 to 94% of the population, and we do not want to go back to the bad old days…. …The problem is neither OxyContin nor the growing use of opioids in pain management. The problem is poor assessment and monitoring, and a shortage of settings that can treat pain and bring the needed amount of structure to bear when appropriate. This issue defies the oversimplification that has been ever present in the historical dialogue about opioids. In the end, members of the pain management community are going to have to lead the way of making sure that stories of abuse and diversion of OxyContin do not get caught up in a firestorm of histrionic rumor mongering. Rumors about prescription opioid abuse make for lurid and unfounded tales that have all the appeal of tabloid television and will ultimately do pain experts and their patients much harm.” Treating pain while preventing abuse and diversion is an enormous challenge; which is why it is tempting to lay all the blame on a drug company when something goes wrong. FOX’s tabloid television assault on Purdue Pharma for “killing scores of people” may give the impression that Rivera is tough on drugs, but all it showed is that he was soft on the facts. It would have been a real benefit to the public if FOX (or the Newshour for that matter) had tried to reconcile Brownlee’s statements with the actual plea agreement, or the scientific data, or even expert opinion on pain management.
Geraldo Rivera on OxyContin’s “Corporate Bloodsuckers”
FOX News' tabloid vampire feeds on District Attorney’s exaggerations; what happens when grandstanding goes unchecked, when data is ignored.
According to an article in the February 2007 issue of the Clinical Journal of Pain (Foundations of Opioid Risk Management, Katz et al), some 75 million Americans experience acute, chronic pain each year, and most of them will be inadequately treated, “despite the availability of effective treatment options for many sufferers.”
The National Survey on Drug Use and Health first asked about OxyContin in 1999, and estimated that 221,000 people had used OxyContin in their life for a non-medical use. The estimate rose to 558,000 by 2001, which still put it below drugs like Vicodin and Percocet. The late 1990s saw a massive overall increase in pescription drug abuse of all kinds.
The spike in OxyContin abuse, however, coincides with a massive increase in news stories about the danger of the drug, some of which noted how to defeat the time-release mechanism by crushing the pill and snorting or injecting the powder. According to Factive, a databse of over 10,000 publications, mentions of OxyContin abuse went from 96 in 2000, to 2,518 in 2001. It is hard to see this as an accidental correlation.
What is noteworthy is that when Brownlee was pressed on the Newshour with Jim Lehrer as to why he had not sought felony indictments that would have sent Purdue executives to jail, he was forced to admit that (after over five years perusing millions of documents), the evidence wasn’t there to convince a jury. Hence, Purdue was fined for “misbranding.” (It should be noted that the Newshour segment did not include any pain experts, or pain patient advocates to counter the criticism of OxyContin). Brownlee made statements to the press that
risk way of reducing pain as promised. Simply put, the genesis of OxyContin was not the result of good science or laboratory experiment.
OxyContin was the child of marketeers and bottom line financial decision making.”
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