Viewpoint: Is It a Bad Time to Be in Pain?
"It is a bad time to be in pain. Last week the maker of OxyContin agreed to pay $635 million to settle charges of "misbranding" brought by the Attorney General of West Virginia."1
—Dr. Sally Satel, addictionologist, The Wall Street Journal, May 15, 2007
This was one of the largest amounts ever paid by a pharmaceutical company in such a case. The burgeoning views regarding Purdue’s predicament have left pain management in a conundrum.
Dr. Satel also states, “The real public health damage here comes from the pitch campaign conducted by zealous prosecutors and public interest advocates to demonize the drug itself. This is tragic because OxyContin has been a godsend for millions of patients with searing, unremitting pain from chronic back problems, rheumatoid arthritis, neurological disorders, and other dire afflictions.”1
She points out what those of us in the pain world already know: “This latest bad rap for OxyContin threatens to inflict more pain. Doctors already wary of scrutiny by the Drug Enforcement Administration (DEA) will become even more skittish about giving adequate doses of OxyContin or prescribing it at all. And patients will be rightly scared of losing access to the medication that makes their lives livable again.”1
In their October 21, 2001, consensus statement, the DEA and 21 healthcare organizations had agreed that “effective pain management is an integral and important aspect of the quality of medical care and pain should be treated aggressively.” They also noted that opioids are often “the most effective way to treat pain and the only treatment option to provide significant relief.” They further stated that “focusing only on the abuse potential of the drug, however, could erroneously lead to the conclusion that these medications should be avoided when medically indicated, generating a sense of fear rather than respect for the legitimate properties.”
OxyContin, in particular, is an important part of our armamentarium today. Oxycodone (the active ingredient of OxyContin) has been available for 90 years. Like other pharmaceuticals, there are risks associated with opioids. One of the risks associated with the use of opioids is addiction. OxyContin, like a number of other opioids, is a Schedule II narcotic under the Federal Controlled Substance Act.
A statement from Purdue’s Public Affairs Department on May 10, 2007, is as follows: “Nearly 6 years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some healthcare professionals that were inconsistent with the FDA-approved prescribing information for OxyContin and the express warning it contained about risks associated with the medicine. The statements also violated written company policies requiring adherence to the prescribing information. The misstatements were made prior to July 2001 and related to the risks of addiction abuse, withdrawal and tolerance compared to other pain medications. We accept responsibility for those past misstatements and regret that they were made. During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again. In July 2001, we added amplified warnings to the prescribing information and communicated those warnings to healthcare professionals. Any attempt to connect the plea agreement of misbranding by Purdue with abuse and diversion of OxyContin is completely false. The papers filed by the government do not make any such allegation. The company’s plea did not involve an admission of such wrongdoing. We promoted the medicine only to healthcare professionals, not to consumers. We never, for example, advertised OxyContin on television. OxyContin can only be lawfully obtained with a prescription from the healthcare professional. The instructions contained in the prescribing information for medication, and which were approved by the FDA, have always contained express warnings and precautions about abuse, addiction, tolerance and withdrawal. When OxyContin is misused or abused, injury is possible. Substance abuse is a serious problem with often tragic consequences, whether it involves our medicine or any other medicine intended for use by patients. “
Purdue Pharma is a research-based pharmaceutical company known for pioneering work on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. For years, Purdue has established innovative and effective programs to help physicians, pharmacists, and law enforcement combat prescription drug abuse and diversion. Additional information about Purdue can be found at www.purduepharma.com.
On a personal level, the Purdue pharmaceutical representatives I have dealt with have been professional, well-informed, and never misleading. OxyContin package inserts have been helpful and always contain appropriate warnings, including warnings about the risk of addiction, physical dependence, and withdrawal.
“The 2002 national household survey on drug abuse found that among those who took OxyContin without a prescription, 98% had used other addictive pain relievers for non-medical purposes, and more than one-fourth had used heroin.”1
Dr. Satel also states in 2003, that, “The Journal of Analytical Toxicology reported that in less than 2% of the 919 OxyContin-related deaths, OxyContin was the only drug found at autopsy.”
According to the National Institute on Drug Abuse, “Abuse of narcotic analgesics is rare among legitimate patients taking adequate doses as prescribed.”1
On May 11, 2007, The New York Times states that, “The Purdue executives had defeated hundreds of lawsuits from patients claiming they had become addicted to OxyContin. The company’s defenders included former New York Mayor Rudolph W. Giuliani. His firm was hired in 2002 by Purdue as part of a crisis management strategy. Mr. Giuliani was also present—acting as a lawyer for Purdue Pharma—at several meetings last year between Justice Department officials and defense lawyers for the company and individual executives.”2
Satel, in The Wall Street Journal, states, “Was the penalty for Purdue Frederick out of line? I don’t know. But the price for those already in pain promises to be steep. Pharmaceutical development of improved slow-acting opiate medications may be derailed by fresh paranoia. More law-abiding physicians wary of litigation or regulatory scrutiny may withdraw from prescribing potent painkillers. It is hard enough for pain patients to get treatment. This newest injection of malignant hype is the last thing they need.”1
Under-treatment of chronic pain runs as high as 50%. With the reversing of the aging of the population, this number will be increasing rapidly over the next several decades. The effects of under-treatment of pain can be devastating, including, for example, depression (suicide), anxiety, loss of sleep, social and sexual dysfunction, loss of work, weakness, fatigue, gastrointestinal distress, hypertension, and tachycardia.