Introduction: Raymond Sinatra, MD

The first person on our panel is David Joranson, he has a master of science and social work, he's the director of the Pain and Policy Studies Group, University of Wisconsin School of Medicine. Neil Jobalia, he's an anesthesiologist at Fort Hamilton Hospital in Hamilton, Ohio. Jean Dunegan, MD is a general surgeon and pain specialist and she practices at Hillsdale(?) Community Health Center, Hillsdale, Michigan. And John Burke(?) is commander of the Cincinnati Police Department in Cincinnati, Ohio. We're also joined by Clarinda MacLow of Anesthesia Web.

I'd like to start with my introduction, and basically what I'm trying to do is frame the discussion. Basically I think we know that during the last four to six months we've noticed increasing concern regarding the issue of diversion and abuse of opioid analgesics. Now this issue to me at least comes at a critical time because after decades of neglect and under medication of patients with severe pain we finally have a number of new analgesics and analgesic delivery systems. And the development of these analgesics has really improved patient comfort and functionality for most patients suffering severe pain.

And the pharmaceutical industry I believe, in a legitimate attempt to improve pain relief, developed sustained opioid analgesic preparations. Now these have become widely accepted by patients and pain specialists, and there's a variety of them. They include sustained release morphine, which is MS-Contin, also there's a preparation called Kadian, there's also sustained release oxycodone which is OxyContin. We're still testing a hydromorphone sustained release product called Dilaudid-CR.

These preparations, as you know, were designed to provide more uniform and prolonged pain relief with greater patient convenience. In theory they would avoid the high peak plasma levels of drugs that were responsible for the adverse events that we see with the short acting agents. And hopefully they'd minimize the euphoric effects and risks of abuse. They also would avoid the plasma troughs responsible for poor pain relief.

Now these sustained relief opioids as you know are formulated in high dose concentrations. Typically they're many times higher than that provided in the short duration agents. However, you only need one to two tabs a day rather than four to eight short acting pills, although the 24 hour daily dose for the patient usually is the same.

With regards to OxyContin, we all know it's a widely prescribed sustained release product, and it's manufactured as a two component tablet. The outer shell is similar to most other pain pills, contains oxycodone that is immediately released, and it's responsible for the rapid onset and analgesic effect. The inner matrix of the tablet is composed of oxycodone that's bound to a slow release component. And this is responsible for the reliable and sustained effect.

The high dose associated with the matrix component makes it a target for those interested in diversion and abuse. As I said, it's a fairly high dose and it becomes obvious that by manipulating the tablet, either by crushing the matrix, the entire 12 to 24 hour dose can be administered in a way that you can achieve the effect of the entire 12 to 24 hours within seconds. And this results in a very intense euphoric effect, a very high high as you would say. But also very serious life threatening respiratory depression.

Now, because of the issue of over dosage and death, the DEA has threatened to take some drastic steps. In a comment made during a recent meeting, Mr. Marshall, who's the administrator of the DEA said he is seriously considering rolling back the quotas that the DEA set for oxycodone from the present level back to 1996 levels. Well, if this were done basically you'd reduce the number of prescriptions from the current 5.4 million down to about 290,000 and that would only supply about five percent of the current demand for the product. Essentially such a quota would make OxyContin unavailable for most patients who need it desperately for severe pain.

With these comments I think I now would like to turn to the other members of the panel and I think I'd like to turn first to David Joranson who's labored for years to reduce the problem of under medication in pain. I'd like David, if you could comment on this and other issues.