Here We Go Again
Here we go again, folks. The latest attempt to “address misuse of painkillers” is here. As I was watching cable’s Fox News Channel the other night, the following appeared on the crawl at the bottom of the screen: “FDA asks 16 drug companies to attend meeting March 3 and articulate plans to address misuse of painkillers. The drugs in question are opiods, which include morphine, oxycodone, and methadone. The painkillers are highly addictive and cause hundreds of deaths each year because of misuse. Fed regulators say deaths have occurred after doctors prescribed opiods for migraine headaches, an unapproved use of the drugs.” The next morning I opened my Wall Street Journal to read “Pain Drugs to Get new Restrictions” by Jennifer Corbett Dooren. ( http://online.wsj.com/article/SB123423345361966311.html ) As I said, here we go again.
As the Lost In Space robot said, “Warning, Will Robinson. Warning!” According to Ms. Dooren’s article, “New government figures show a rise in nonmedical use of prescription pain drugs among adults.” So, cutting through the bureaucratic-speak, it all comes down to the age old issue of the ne’er-do-well driving decisions that have a direct negative impact on those of us who have a legitimate need for a medicine. The manufacturer raises the price to compensate for higher product liability insurance if they even continue to manufacture. The physicians, assuming they continue to even prescribe the medication, raise their prices to compensate for the higher malpractice premiums which assumes the insurance company even continues coverage. The pharmacy raises prices to compensate for high liability premiums assuming the pharmacy will even fill said prescription. And on and on and on. See the pattern here? All this because some dope (no pun intended?) broke the law. The end result: My access to quality healthcare is jeopardized, if not ultimately denied.
The crawl mentioned three opioids: morphine, oxycodone and methadone. Checking the websites of the manufacturer’s, I could find no elimination of headache, therefore an “unapproved” use. For morphine, I checked the information for both Kadian® and MS-Contin®, each a long acting form of morphine. To quote from the Kadian® website: “KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY).” ( http://kadian.com/pages/getfile.aspx?id=1C6197AB-8F83-43E7-B239-D4615293989B ) In reading the entire Alpharma Pharmaceuticals LLC “Full prescribing information” blurb, I could find no specifics concerning the precise application for the medication other than “moderate to severe pain”. For MS-Contin®, I looked at the Purdue Pharma site and similar verbiage: “MS CONTIN® Tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.” ( http://www.purduepharma.com/PI/Prescription/Oxycontin.pdf ) Again, nothing to indicate migraine is eliminated. For me personally, “moderate to severe pain” and “continuous” certainly apply.
Oxycodone, under the trade name OxyContin® contains a similar statement from its manufacturer Purdue Pharma: “OxyContin® Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the clock analgesic is needed for an extended period of time.” ( http://www.purduepharma.com/PI/Prescription/Oxycontin.pdf )
Then methadone. “For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.” That blurb from Roxane Laboratories, Inc. Of Columbus, Ohio, the first manufacturer that popped up when I did a web search. Again, no specific ailment other than “moderate to severe pain”. ( http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Roxane/Methadone/Methadone+HCl+Tablets+5mg+10mg.pdf )
Back to Ms. Dooren’s article: “The letters told the drug makers of agency plans to require a risk-evaluation and -mitigation strategy, or REMS, “to ensure that the benefits of the drugs continue to outweigh the risks.” “. It is becoming clear to me the largest personal risk to me is denial of service. Short-acting opioids are not an option because of all the potential physical detriments, not the least of which is damage to my liver. Or I could simply go off medication all together and watch my, as well as my wife and family’s, quality of life go straight down ultimately ending up with psychological care and an time consuming focus on the pain in my head instead of living life. The article further reports “There will be no immediate changes for prescribers or users of extended-release pain pills.” However, it seems that every time there is discussion of this topic, the focus is on blanket restriction of distribution which has the resulting negative impact on deserving sufferer’s and no impact on the ne’er-do-well. As Ms. Dooren reports, “The agency noted that previous efforts to cut down on abuse and misuse of extended-release products, such as putting additional warnings on products labels, haven’t really worked.” And then the clincher, “Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade,” the agency said in a statement posted on its Web site.” With all due respect to the FDA, even I could have predicted drug abusers will not respect any rules, regulations and/or any effort by government and/or manufacturer’s to control usage. One expression sums it up: “Duh”.
Finally, again quoting the Wall Street Journal’s Jennifer Dooren, “The FDA said it would meet with the drug manufacturers next month to talk about developing a REMS and would then meet with other federal agencies, patient and consumer-advocacy groups and health-care professionals to get additional input in the coming months.” Make sure you are part of that input. As part of local government bureaucracy for 30 years, I inter-acted with state government. A person at the state level for whom I have the utmost respect taught me a lesson many years ago. When I asked about making a regulation to prohibit certain behavior (unrelated to medicine), I was told to be very careful of what I wished for. Regulations target the lowest denominator which, of course, creates those pesky “unintended consequences”. Target one segment of an issue and all segments get drawn in. All or nothing.
Thankfully, we have a little warning. It seems that we are normally whacked with new government regulations with no warning at all. Again, make sure your voice is heard.
June 5th, 2009 at 12:12 am
Hi. I have been reading your site, on and off, for a few years. Like most people who visit your blog, I have chronic headaches. I am probably one of the most cynical people regarding the treatment of chronic headaches and I honestly do not think patients with intractable headaches are well served at all. So much of the information provided by doctors and faithfully repeated by reporters and respectful patients is poorly founded. In fact, with the exception of clinical trials for the leading acute care meds, particularly triptans, much of the advice and recommendations are based on little more than opinion. There is no doubt that most headache specialists are opinionated and tend to have a strong anti-opioid bias.
I noticed that concern regarding medication overuse headaches was amped up at the same time that opioids started to be recommended for non malignant pain. Many headache specialists proclaim support for pain sufferers and even the use of opioids. They are careful to point out however, that headaches are an exception because of the risk of rebound. How convenient. Everyone else seems to buy this crap.
I am not saying that people should take huge amounts of medicines for headaches or that frequent medication use for headaches is not problematic. I do think, however, that we are a long way from understanding the pathophysiology of chronic headaches and the true cause and effect relationship between chronic headaches and chronic medication use. What I have real problems with is how easily headache specialists accept leaving their patients in pain based on a poorly understood diagnosis.
But thank you for your consistently intelligent blog. Keep up the good work.
Carol Kennon