Canada has ordered OxyContin removed from pharmacies, in response to the continuing abuse of this powerful opioid. Many groups, including First Nations members with high numbers of addicted persons among them, are warning that the move will push people to more dangerous drugs such as heroin. We look at the OxyNeo replacement drug, what its implications are, and related aspects, including whether doctors are under- or over- prescribing powerful and highly addictive pain medications.
HOWARD: Welcome to the CNS Podcast featuring Dr. Darryl Inaba, research director for CNS Productions, I am Howard La Mere. Today I'd like to talk about a story about OxyContin - it’s no longer available in Canada, at least in Ontario. A new version is being marketed that’s harder to abuse and a story coming out of New York, Long Island…citing the fact that prosecutors are faulting doctors for the prescription drug epidemic that has swept the country in the last 10 years. We’ve talked about this before, Darryl, but it goes to the question of how we’re addressing pain in general in our society and the way that we’re increasing our dependence on pharmaceuticals, maybe to the exclusion of different options that are not big pharma and that might be worth looking at. So, what’s your take on this in terms of what new perspectives might have crossed your plate in the last couple months?
DARRYL: Well, the OxyContin story in Canada is an interesting one and it raises a lot of suspicions in my mind, it was hard to tell from the stories what exactly happened other than the fact that Canada, like the United States, has been experiencing a great increase in opiate addiction, opiate overdose and abuse or diversion of opiates for abuse purposes. And the article mentions that it was in March of this year, 2012, 2 months ago, that Purdue Pharma quit producing OxyContin in Canada, maybe throughout Canada - not just the province of Ontario.
HOWARD: I’m not sure.
DARRYL: There are a lot more treatment requests for opiate addiction, a lot more people panicking about what’s going to happen and that OxyContin was a highly abused drug. What they didn’t say was whether it was banned outright, but it seems like a voluntary cessation of manufacturing and distribution in Canada by Purdue Pharma. And then the story followed up very quickly by saying that they had introduced an alternative drug and the alternative drug, Oxyneo, was meant to be more diversion resistant and the way I read it - that this alternative drug is now available. They’re not going to make OxyContin available and it seems with the alternative drug coming on, there will be a new marketing strategy and higher product pricing than the older OxyContin, which is probably going off patent very soon and it might be another case of - follow the money, Howard! Here we go again with pharmaceutical companies manipulating the markets to try and sell something.
HOWARD: It could be a patent issue . I understood from the article that it’s harder to crush this medication therefore has less abuse potential. Of course the street will figure out a way - but often that makes it more dangerous than it was otherwise….so….
DARRYL: Well, you know, we should just follow the history here. Purdue Pharma got a waiver around the maximum dosing of oxycodone, which is in Percodan and only available 5 mg at a time, mixed with acetaminophen as a schedule 2 drug. They got around that schedule 2 when they upped the mg to 120 mg or more of oxycodone in the OxyContin tablet and said it was diversion resistant or unlikely to be abused because they had locked up the chemical, oxycodone, in time-release granules that nobody could abuse. If people took an excessive amount, this form would release a small amount at any one time. Well, how long did it take the street to figure that one out?
HOWARD: Oh, about 2 hours.
DARRYL: Crush up your tablet and shoot it or do whatever with it and it became one of the most abused opiate drugs of all times. This lead to this renewed epidemic, of not just prescription drug addiction, but actually an epidemic…or an increase after 9 years of steady declines in substance abuse in America. Since 2009, abuse has seen a steady increase. This new formulation Oxyneo as you mentioned, is harder to crush up and inject and abuse but the street had already figured out a way to do it. Apparently it’s the easy way to get around the loss of profit and the prohibitions society places on certain drugs by coming up with these supposedly Neo devices that supposedly deters - but never deters anything - and allows you to price it at a higher price point and market a new product or an extension of a patent because it’s a reformulated product.
HOWARD: And then that takes up the consideration of, well - if you made these drugs less illegal … or decriminalize them - would that remove a significant amount of the money aspect and would it be in everyone’s best interest, especially if some of the money that would come from things like taxation, was funneled towards treatment as opposed to being funneled towards the general fund, which is logically where it would go because most of the states are in deep fiscal water. But, that’s a different discussion, but I thought it was worth mentioning.
DARRYL: Well it raises two issues. I don’t understand where all this is leading to in terms of prescription drugs and diversion of prescription drugs. If you’re looking at what’s happening on the street right now in terms of drugs, it makes this whole war on drugs - diversion of prescription drugs really a moot point. Maybe even looking at diversion of illegal drugs a moot point because what’s happening now is the emergence of a plethora of synthetic chemicals and new chemicals and new age plant substances that are just as effective or more powerful than cocaine, methamphetamine, heroin, marijuana, things like that. They’re just flooding the market.
HOWARD: And these can be created before any legislation can be enacted to regulate them.
DARRYL: And they can be produced and distributed before there are tests to detect them - so they’re going to be legal for awhile. It makes it much simpler for people who are interested in abusing drugs to get drugs that way and to not be recognized. Unfortunately the people using them are ignoring the fact that these drugs are addicting and that certain people have a predisposition addiction and that regardless of whether they are legal or not, and even if you don't get busted, the outcome - if you do have a propensity - is going to be a total nightmare and have grave consequences. So, it’s not good news for people who are prone to addiction and it’s not good news for law enforcement or anybody that is trying to prevent these things or really for Purdue Pharma or any other major company who is trying to market these drugs to a specific population and has the street as competition.
HOWARD: And of course …one of the key dangers is not knowing, because these products are so new - the potency is unknown.
DARRYL: Well, there is no vetting on whether these are effective,
HOWARD: It’s all going to be anecdotal.
DARRYL: We'll have like in the 1960’s, an uncontrolled human experimentation on a massive number. People will take these things because they are new, non-detectable, and still legal. There are stories about some of the spice series causing kidney failure in Montana. Well, we don’t know for sure, it is suspected that it was a certain spice that caused this and until we research it out, this chemical series that is being sold as spice actually continues to damage kidneys or cause cancer or a number of other things. The average number of years it takes for a drug to be approved by the FDA in order to be sold as a medicine is 17 years and the drugs must go through rigorous animal and human testing - and even then we get things wrong, you know.
DARRYL: Often things go wrong. These substances are made up in the laboratory, maybe there is a little published information about them as an experimental substance. The next thing you know, everybody is talking about it on the street and we have to sit back and watch what happens to the people who used the substance and determine if they are dangerous.
HOWARD: And as you say, it can be a couple of years before anything shows up - meanwhile, people have been blithely taking them and some really unfortunate or unforeseen side effect shows up.
DARRYL: You know that’s a good point, Howard, because we tend to concentrate on the immediate and so, if there’s a rash of overdoses…if there’s a rash of people being diagnosed with Parkinson’s or cancers, we say, oh my gosh, that drug is really dangerous to cause those things so quickly. But we forget that sometimes the harm caused …let’s say from nicotine for instance…is a long term process and it may be generations before all the toxic effects are recognized. I remember the hepatitis C virus…when that first appeared, we didn’t know anything about about it - we weren’t looking for it and it took several, maybe a decade or two before the manifestation of that disease showed its face and then we discovered many people were infected years ago from their use of drugs and alcohol. And they didn’t know it.
HOWARD: Now on to this story coming out of New York, Long Island ... attacking doctors ... criticizing doctors in mass, the medical establishment in masses for being ...
HOWARD: Enablers. Enablers of people with a proclivity towards addiction by making it easy to obtain drugs by responding to people’s need for help with pain…relief from pain... and readily prescribing these prescription opioids, analgesics that are ... so prevalent in abuse.
DARRYL: That story really misses the facts. Having looked at the research data on the way people get prescription opiates and how they are diverted to abuse practices - by and large, …they’re not getting them from a physician prescribed them or from a physician who is just selling them or from a pharmacist sneaking them out the backdoor they’re getting these drugs from friends and family members. They get them from people who probably have legitimate needs, but don’t as many of the medication as they have so they just sell them or they give them to their friends and family members who then become addicted. But, the diversion of these prescription drugs are basically coming from friends, families and off the street, not from doctors. Having said that, we’ve also talked about …this pendulum that swings back and forth when you’re looking at something like pain where doctors are summarily persecuted for under prescribing pain medication and horror stories about patients' legitimate needs that go unmet because doctors are so afraid of being abused or misused by those looking for drugs that can be diverted for abuse practices. Actually, there have been instances where doctors were prosecuted for not adequately treating pain. And we’ve been on that pendulum swing for quite awhile now, maybe a couple decades. In Oregon it is a crime not to adequately prescribe medication to treat pain. And that seems to have hit a peak and now with all the stories and reports of abuse of these drugs, the pendulum is swinging the other way, where doctors are now being persecuted for over prescribing. I think some day we’re going to have to hit a happy medium here and understand that there are valid pain situations and doctors are going to have to spend more time with patients and decide how much and exactly what drugs are needed. A couple of the prescribing practices, or prescribing problems that occur with this is sometimes pharmacies and sometimes Medicare, Medicaid systems reimburse or make the patient copay in different amounts. What I’m trying to say here is that …say you have a wisdom tooth extracted - you’re only going to need pain medications for a couple of days, so the doctor prescribes maybe 8 OxyContin. You go to the pharmacy to pick up that 8 and it’s going to cost you…because of the pharmacy filling fee and the doctor’s ordering fee and all that, it’s going to cost you maybe 100 bucks, let’s say …for just 8 pills. Whereas you could have gone to that same doctor…he could have given you a prescription for 30 of them or 50 of them and it would still cost you 100 bucks or just slightly more and so, to make sure that you don’t have breakthrough pain or any ongoing problems, most doctors are going to prescribe the higher amount just to give you a better bargain. And most insurance plans want to cover the higher amount so that they don’t get hit with the extra costs of having to refill a prescription.
HOWARD: Having to do it again.
DARRYL: Yes. And that results in providing extra amounts of medication that aren’t needed and that ultimately wind up on the street - easily divertible into abuse purposes.
HOWARD: I remember you talking about the grandmother who was a big pusher somewhere - I don’t remember how she got so many drugs, but she was in her 80’s and a major provider of contraband pharmaceuticals.
DARRYL: Elderly people of course are going to be less suspected, although they’re going to become the largest, biggest population of senior drug abusers we’ve seen.
HOWARD: Yes as that group becomes the dominant demographic. …
DARRYL: As the boomer generation become senior citizens they are bringing with them some of their earlier drug experimentations. Heretofore, if you were an elderly patient, doctors weren’t worried about you diverting drugs. Doctors weren’t worried about you selling drugs, so they were more likely to prescribe to senior citizens, who might not take them …they’re already befuddled! They don’t want to take any more befuddlement pills, so they keep them around. There are lots of stories about people who routinely go through garbage cans at nursing homes and about kids who love to visit their grandparents at nursing homes just to go through the medicine cabinets to grab whatever is there. So, we just have to become a little bit wiser about these medications and we have to look at…our practices in terms of how we market them, how we sell them, what the pharmacy practices are so that we can come up with more practicable ways of ending diversion. But it doesn’t seem to me that changing the form of a drug has resulted in an effective way of stopping abuse. There’s tremendous OxyContin abuse in Canada, so now …reformulate the thing into OxyNeo and that may stop the problem. I think that’s the wrong way to go.
HOWARD: It’s simply a direction not necessarily the right one. Well, that’s about all the time we have for today. But we will talk of this topic again because the problem is not going away. Thank you for listening and we invite your comments, questions, and suggestions, - email us from our website. Okay, Darryl, closing thoughts?
DARRYL: Yeah, always great talking to you, Howard. Thank you very much.
HOWARD: Okay…thank you. That wraps our pod for today. Thanks for visiting the CNS Podcast. Please check back soon for the next in the series and visit our website, www.cnsproductions.com