Children Deserve Pain Treatment Too

I hope that people recognize the tongue-in-cheek nature of the title. After working as a physician in various roles over a period of 20 years, I can state with absolute confidence that the answer to the question is ‘yes’.
I’ve written numerous times about the writer/activist for the Salem-News.com web site, Marianne Skolek. I don’t know if she writes for the print edition as well, but at any rate I somehow was planted on a mailing list that provides constant updates on what she calls the battle against Purdue and ‘big pharma’.
People with a stake in the outcome of this battle may want to stay current, and even see if their Senators are involved in the process. The investigation was launched in early may, by the Senate Committee on Finance, and at this point has asked for documents from several pharmaceutical companies, including Purdue, the manufacturer of oxycontin– a medication that has become the focus for most of the wrath of those affected by opioid dependence. The investigation will include a number of groups whose missions are (or in some cases, were) to advocate for pain relief, including the American Pain Foundation, the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the University of Wisconsin Pain and Policy Studies Group and the Joint Commission.
I consider it part of the human condition, the way we push in one direction for some period of time, and then realize (with surprise!) that we pushed too far, and need to push back. Years ago a  Newsweek article warned that an emerging ice age doomed the Earth. Suggestions for saving the planet included covering the polar ice caps with soot, in order to absorb more of the sun’s precious heat– although the article pointed out that growing seasons had already been severely limited in most parts of the world, and famine was just around the corner.
We all know what happened to THAT disaster. And then last week, Dr. James Lovelock, a leading doomsayer of the global warming movement, pointed out that many of the disastrous outcomes predicted by himself, featured in Al Gore’s movie, um…. haven’t happened… and to the chagrin of many, he wrote that most of the disasters that were predicted are unlikely to occur. Read for yourself. Never before were so many people so disappointed by good news.
I’m running off topic, I know, but it is hard to observe the dramatic swing on pain relief without recognizing the broader pattern. For those confused about the pain isssue, you have reason to be confused. About 15 years ago I worked as an anesthesiologist, when the Joint Commission on Accreditation of Hospitals made their 3-year site visit to our hospital. Hospital administrators hired consultants to find out what THAT year’s big issue was— e.g. hospital acquired infections, patient privacy, rights of those with disabilities…. and found that the hot-button issue was ‘undertreatment of pain.’ Little diagrams were dispensed to every patient room, showing the smiley-face guy with an expression ranging from happy to miserable, in case a person was experiencing pain but unable to speak– allowing the person to point to the appropriate picture instead. Key personnel were told to make it abundantly clear that we all take pain VERY seriously, and we do all in our power to avoid undertreatng because of, for example, fear of addiction. Studies were widely cited that claimed that only 7% of people with true pain become addicted to opioids.
One or two textbooks became the authority on opioid prescribing, introducing a new term– pseudoaddiction– which refers to a condition of drug-seeking behavior caused by under-treating pain, rather than by true addiction.
I know that I have to pull all of this together at some point. The easiest way for me to do that is by directing people to the latest article by Ms. Skolek, where she suggests that doctors have been influenced to promote narcotics because of grants from the pharmaceutical industry. Similar accusations have been made by others, including a series of articles by the Milwaukee Journal Sentinel that accused the University of Wisconsin School of Medicine of promoting opioids in return for millions of dollars.
I respect the efforts of another group I’ve described– PROP, or Physicians for Responsible Opioid Prescribing. Their efforts have been promoted by Ms. Skolek to some extent, and vice versa. I do not know of any formal relationship between PROP and Ms. Skolek. But I hope that PROP’s efforts take a more reasoned approach than the latest article by Skolek, where she compares Purdue Pharma to Adolf Hitler. Why? Because among the many clnical trials by Purdue is one that studies the use of potent opioids like Oxycontin in children and teenagers. Some of the most sobering experiences of my medical training were at Childrens Hospital of Philadelphia, providing care for brave, hairless children, knowing the years of pain that awaited them– if things went well.
I think I’ve provided enough background and links to start interested parties off on their own holiday reading. Yes, there is an epidemic of opioid dependence in this country and elsewhere. There are many reasons for this epidemic, and MOST of the reasons have nothing to do with the marketing tasks used by Purdue decades ago– for which they have paid dearly. While there are clearly areas where opioids are overprescribed, and in some cases grossly overprescribed, it would be a shame if the current swing in regulatory sentiment takes us to the point where doctors are afraid to provide pain relief for people who are suffering. This is already the case in some instances; people labelled as ‘addicts’, no matter the length of their remission, are likely to wait a long time for their first dose of narcotic, should they be unlucky enoough to develop a kidney stone.
I’ve spent a great deal of time and energy defending those poor souls, and discovered, sadly, that most doctors just don’t care about the pain experienced by recovering addicts. But there is a saying, also often referenced to the Holocaust, referring to mistreatment of others being ignored, until eventually similar mistreatment is directed at those who didn’t care about others. There are times when attempts to ‘cure’ go too far. Suggesting that methods of pain relief should not be investigated, clarified, and perfected for children is going a bit too far.

Inconvenient Truth

Next month I will be presenting a paper at the annual meeting of ASAM, the American Society of Addiction Medicine. The paper discusses a new method for treating chronic pain, using a combination of buprenorphine and opioid agonists. In my experience, the combination works very well, providing excellent analgesia and at the same time reducing—even eliminating– the euphoria from opioids.
Ten years ago, I would have really been onto something. Back then there were calls from all corners to improve the pain control for patients. The popular belief regarding pain control was that some unfortunate patients were being denied adequate doses of opioid medications. I remember our hospital administrators, in advance of the next JCAHO visit, worried about pain relief in patients who for one or another reason couldn’t describe or report their pain. Posters were put up in each patient room, showing simple drawings of facial expressions ranging from smiles to frowns, so that patients in pain could simply point at the face that exhibited their own level of misery.
What a difference a decade makes! Purdue Pharma, the manufacturer of Oxycontin, was fined over $600 million for claims that their medication was less addictive than other, immediate-release pain-killers. Thousands of young Americans have died from overdoses of pain medications, many that came from their parents’ medicine cabinets. Physician members of PROP, Physicians for Responsible Opioid Prescribing, have called out physicians at the University of Wisconsin School of Medicine and Public Health for having ties to Purdue while arguing against added regulations for potent narcotics.
I have tried to present both sides of the pain pill debate, without disclosing my OWN opinions on the issue—at least until today. And I must be at least somewhat ‘fair and balanced,’ because I’ve received angry messages from both sides—from people telling me I’m evil for not understanding their need for pain medications, and from people telling me I’m evil for not respecting the danger of the medications.
By the way… I have a policy of not printing messages that simply call me names, or that tell me how bad a doctor I must be for writing what I do. I love a good argument, so please feel free to comment on ANY points that I’m trying to make. But I don’t think that making efforts to lead a discussion warrants personal attacks—so please, stick to the issues!
Today, though, I would like to share a couple thoughts on the issue. The thoughts came after a discussion with one of my patients with chronic pain. I have been presenting one side, then the other side, and back again, trying to remain neutral… but from all that I’ve seen as a psychiatrist and as an anesthesiologist, some things cannot be denied.
1. Some people do have chronic pain that responds to opioids. Many doctors—including the doctors who are afraid of the DEA, or the doctors who don’t want to deal with the hard work of prescribing opioids, or the doctors who want a simple world where ‘pain pills are always bad’—don’t want to admit the truth of this statement. This is, with apologies to Al Gore, a very inconvenient truth.
I find it interesting that doctors who don’t want to prescribe pain pills act as if chronic pain does not exist– as if the suffering of people with painful disorders is less important in some way, if it lasts too long. Every prescriber is aware of the need to treat acute pain, but when it comes to chronic pain, the difficulties that arise with treatment (e.g. abuse, diversion, tolerance) lead some doctors to act as if something magical happens on the road from acute to chronic. The phenomenon is the exact opposite of the old saying, ‘to a man with a hammer, everything looks like a nail.’ In this case, ‘to doctors who don’t want to use hammers, there ARE NO NAILS.’ But in truth, there ARE nails; some patients have lots of them. And we doctors have a duty to hammer away at them… (OK, enough with the analogy already!).
2. Just because some people divert opioids does not mean that other people shouldn’t have necessary pain relief. Treating pain is about as fundamental as medicine can be. I do not understand the doctors who say ‘I do not treat pain—you’ll have to see someone else’—especially when there are no doctors available to fill that role. More and more ‘health systems’ are adopting this position, at least in my area. What gives?!
3. At the same time, there is no such thing as ‘complete pain control.’ Tolerance removes the power of narcotics, and chasing tolerance always ends badly. Patients with chronic pain must use ALL tools available, including non-narcotic techniques.
4. Being prescribed pain medications comes with certain responsibilities; the responsibility to use the medications appropriately, to communicate openly and truthfully with the prescriber, to avoid ‘doctor-shopping,’ etc. At some point, patients who refuse to honor these responsibilities will lose access to pain medications—at least to some extent. Is this humane or fair? I think so, as access to pain relief for these patients is balanced against the lives of those killed by illicit use of these medications.
I’m sure I could go on… but for now, this is enough food for thought. Besides, it’s almost time for dinner! Feel free to comment—but please, be nice!
 

Consequences Section

Weeks ago I posted a few new ideas—things like a memorial wall for victims of opioid dependence, and a ‘wall of shame’ for doctors who are known for reckless prescribing of opioids.  I mentioned these ideas over at SuboxForum as well.
I received good feedback from readers here, and from members there.  Sometimes the best feedback is the hardest to hear;  I’ll get excited about a certain plan of action, and like anyone, I don’t like it when someone rains on my parade.
One of my addiction docs from years ago was big on ‘sober thinking.’  Back then, it seemed as if anything I came up with that pushed the boundaries was in need of more ‘sober thinking.’  I wondered if ‘sober thinking’ was simply code for ‘I don’t want to say yes to your idea, and maybe that was the case in SOME instances.  But I now recognize a part of myself that acts quickly, impulsively, with great optimism, and with little regard for risks.  ‘Sober thinking’ is simply letting an idea sit in one’s mind for a few days or even weeks, and keeping a truly open mind to the comments that one receives about the idea.

Prison is a better consequence to heroin addiction
Beats Death--- Barely

I won’t spell out who wrote to me, but I’ll thank the people who did—who risked my ire by giving their honest opinions.  I mentioned a memorial page;  some people pointed out that a memorial on an addiction-related web page may add to the pain and shame felt by family members.  As for my ‘doctor wall of shame’, I was reminded that every story has two sides, and it may be more useful to simply provide referenced information that would allow readers to make up their minds without my own coloring of the facts.  I want to thank the people who wrote, and let them know that they made a difference—and the site will be better because of their efforts.
Instead of the earlier ideas, I added what I am calling the ‘consequences’ page.  The page will contain news stories identified to Google as having ‘drug overdose’ in their tags.  The information will be replaced every 24 hours or so.  I experimented with a couple different intervals and found that no day went by without a significant amount of news under that tag—a rather compelling statistic!
Click on ‘consequences’ to check it out, and let me know what you think!

Unintended Consequences

I saw a patient from up north earlier today, and we tallked about the economy in his part of Wisconsin and in the Michigan Upper Peninsula.  From what he had to say, things are the ‘same old same old;’ i.e. jobs are few and far-between.  Seems as if it has been that way for a long time now.  And it’s hard to imagine any industry doing well enough in the current economy to make a dramatic change up there.
One change that HAS become apparent over the past year is the increased availability of heroin, now easily found in small towns throughout the upper Midwest.  I’ve seen the same trend closer to my practice, where heroin use has grown from a Milwaukee phenomenon to just another high school temptation.  And a troubling comment pops up more and more during my discussions with people actively addicted to opioids:  “Now that O-C’s are abuse-proof, we gotta’ use heroin.”
I’ve mentioned the requirement for REMS– Risk Evaluation and Mitigation Strategies– for opioids announced by the FDA about a year ago.  The requirement for REMS on a class-wide basis– a novel use of the FDA’s regulatory powers– places pressure on the manufacturers of opioids to find solutions to the epidemic of opioid dependence. One result has been the development of medications with lower abuse potential, such as the new formulation of oxycontin, which when crushed (a feat by itself) yields a gooey mess that clogs nasal passages and needles if taken by those routes.  But the law of unintended consequences applies to this domain, as one would expect, given the tangled mess of political, societal, and economic forces involved in the epidemic of opioid dependence.  There are many addicts out there, each subject to severe withdrawal in the absence of their daily dose of oxycodone;  what would a reasonable person expect them to do, knowing the intensity of their desire for opioids– and their fear of withdrawal?  Are they just going to stop?
My last patient explained it just fine… and he isn’t even a D.C. social worker.   “Oxycontin or heroin–  it really doesn’t make no difference.  It’s all the same thing– one just isn’t around anymore.”
Unfortunately, he wasn’t referring to heroin.
I do have a question– a genuine question, not a facetious one.  At least in Wisconsin, diverted Oxycontin is often used nasally, and heroin used by needle.  I’m sure that part of  the reason for that different route of use is because heroin has tended (at least until now) to be used later in the course of addiction, and there is a progression to parenteral use of substances over time, as addicts seek more efficient means of using.  My question– are there other reasons that heroin users favor intravenous over nasal use?  To frame the question a bit differently– it appears that the prevention efforts aimed at Oxycontin have caused an increase in the use of heroin.  Did they cause in increase in intravenous drug use as well?

New Formulation of Oxycontin– Will it make a difference?

Oxycontin was not my drug of choice so I don’t know the ins and outs of abusing the medication. But I suppose anything that makes the drug harder to abuse is a good thing. The other things that are being looked at for approval are combinations of agonist with antagonist in small doses– for example Embeda is morphine plus little beads of naltrexone, and orally-active form of naloxone. The naltrexone is only released if the pill is crushed, and there is not enough naltrexone to cause withdrawal, but only enough to reduce the ‘high’. I guess my thought is why limit to a small amount of naltrexone? The drug is not to be injected or snorted, so why not put enough naltrexone in it to make any tampering a very serious downer?
I thought I’d share the article below with you, so you can see how thrilled the FDA is with the new formulation.  Read on…
FDA Panel Recommends Approval of New Oxycodone Formulation
By Emily P. Walker
Published: September 24, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine.
GAITHERSBURG, Md. — An FDA advisory panel voted to recommend approval of a new formulation of oxycodone hydrochloride (OxyContin) that is more difficult to crush or dissolve, and which may deter drug abuse.
By a 14-4 margin, with one abstention, the panel recommended that the FDA approve Purdue Pharma’s application for a new, resin-coated formulation that it hopes will eventually replace the original version, which has been on the market since 1996.
The FDA does not have to follow the advice of its advisory committees, but it usually does.
The advisory panel’s endorsement was less-than-enthusiastic in this case, and members complained that there’s no proof the new version of the drug is any safer than regular oxycodone hydrochloride — one of the few drugs on the market that can be deadly in a single dose.
Purdue’s current pill is meant to be swallowed whole, but abusers can easily chew it or crush it and then snort it, smoke it, or dissolve it in liquid and inject it to achieve a heroin-like high.
Although there is no proof that the new formulation is safer, the panel agreed that making the pills harder to crush, chew, or dissolve into liquid may deter abusers. When the new version of the drug is dissolved into water, it produces a gel, which makes snorting the drug more difficult.
“Clearly the old [formulation] is worse than the new, although I think the difference is relatively small,” said panelist Randall Flick, MD, an anesthesiologist at the Mayo Clinic who voted to recommend approval of the drug.
“My feeling is that there would at least be some incremental improvement in the safety profile,” said panelist Stephanie Crawford, PhD, a pharmacist at the University of Illinois in Chicago.
Some 1.2 million people age 12 and older used OxyContin in 2006 for nonmedical purposes, according to the Department of Health and Human Service’s National Survey on Drug Use and Health.
Purdue originally sought FDA approval for low-dose versions of the new product in 2008, but the agency told the company to develop more clinical data and to apply the technology to all dosages of the drug.
Also, it took until 2008 for the company to convince the advisory panel in 2008 that the drug was any more difficult to tamper with than the original formulation, said panelist Ruth Day, PhD, director of the Medical Cognition Laboratory at Duke University.
This time around, the company convinced the panel that new tablet is harder to dissolve or crush and that the resin excipient might make it harder to take the drug in an unprescribed manner, said Day, who was also a member of last year’s panel.
In one lab test, Purdue researchers used 16 household tools to attempt to crush the tablet into small particles. All 16 tools handily crushed the original OxyContin tablets to a fine powder. Although four of the tools managed to break down the new tablet into shavings or particles, none could turn it into powder.
Even so, FDA staff reviewers concluded that the technology does not make a huge difference in OxyContin’s abuse potential.
Hardcore abusers are likely to devise new ways to break down the harder tablet or figure out which solvents will dissolve it fastest, within “day or weeks of the product’s release on the market,” Flick predicted.
The panelists who voted for approval said they were concerned that Purdue had not developed an adequate Risk Evaluation and Mitigation Strategy for the drug.
The new formulation will keep the name “OxyContin” and be used in seven available doses. Purdue said it will not market the reformulation as a “safer” version.
If it’s approved, Purdue will produce only the newer version and stop shipping the old one.
“Within six to eight weeks [of production] roughly 90% of drug in the supply chain will be the new product,” said Craig Landau, MD, Purdue’s chief medical officer.