The Patient Speaks!

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.

Migraine headache is my life
With me more than even my wife
Between my ears, residence taken
Steadily there whenever I waken

For thirty years, agony & pain
Three decades of annoyance & bane
Doctors here, doctors there
Attempting for the pain to pare

A med for this, herb for that
Basically served to make me fat
Side-effects in my body run
Life became not too much fun

Neurology, psychiatry, allergist too
Psychologist, dentist, Dr. Who?
Each has tried my pain to delete
The podiatrist even checked my feet

We’ve gone to the moon, Mars is next
Migraine relief? Science perplexed
Is it really that hard? Why the big tease?
Relief it seems, won’t happen with ease

Pilled & punctured, potioned with powder
The pain, it seems, gets louder & louder
Help is elusive, invisible to me
Perhaps it is hiding, doesn’t want me to see?

I look in the mirror, blink once or twice
For good measure, I make it thrice
“What’s my problem?” I ask the glass
Is there really a problem, or simply gas?

Take control of yourself, be your cheerleader
Figure out how to lower that migraine-o-meter
No more nay-sayers, keeping you home
Obsessing the pain, filling your dome

This little ditty now comes to an end
No point to be made, no problems to mend
Now excuse me while I head for the door
Of life I wish to partake of more

The news anchor, when involved in a deep discussion with their target, uh, “guest” who is just getting to the meat of their answer “Quickly, I’m up against a hard break” and cuts the interviewee off while continuing for what seems hours with the anchor’s views. Or even “Hi, tonight we have Grand Poobah Bilttsburpflap from the planet XOUBCT with the reason Earth is being invaded. Tell us, Grand Poobah, what your manifesto is. And quickly, as we’re up against a hard break.”

The traffic signals with the new “runner cams” that trip the light to red at exactly 1:100000000 second after I’ve passed the point of no return that the computer says I should receive a ticket.

The runner cam that keeps my lane green until it sees me approaching, then turns my light red even though there is no traffic on the cross street. I can just see some fella in the city’s master traffic camera headquarters laughing like crazy yelling “Carla! We did it to him again!!”

Drivers – truck, car, motorcycle, whatever – that insist on running side by side on the two lane Interstate creating a 20 mile back-up. The auto driver has his cruise control set and will be danged if he’ll touch that accelerator. The truck driver’s governor is set ¼ mile an hour faster than the guy he’s trying to pass. Gimmee a break. Or is that “brake”.

The idiot in front of me at the security check point in the airport. To those of you who have flown in the past 8 years, I don’t have to explain.

The clerk at any retail/restaurant outlet that, when handed a five dollar bill along with 6¢ for a $1.06 order who has no clue or glimmer of how much change to give me.

“Convenience” fees. Why do convenience fees seem to benefit the vendor much more than me?

ATM fees.

to be continued…

Many of us in the migraine community have been fighting for years to have our condition taken seriously. When I began my headache odyssey, I was told by a doctor that many in the medical community viewed migraines as a “little girl’s” problem and that men must buck up, soldier through and never, ever admit that a headache would cause a problem lest they be forever labeled as a “sissy”. Needless to say, the Doc’s comment didn’t help me much other than confirm in my own mind to pursue help. The next few years brought a succession of GP’s, EENT’s, neurologists, dentists for TMJ, chiropractors, allergists, psychiatrists, psychologists, psychotherapists, physical therapists and several other “ists” that I can’t remember. Then there was Mayo Clinic and the Diamond Headache Clinic. Not to mention all the pills, powders, potions, procedures and punctures that came along with the ride. And the X-Rays and the CAT-Scans and the MRI’s and the blood tests and the angiogram and the spinal tap and the arterial biopsy and the bio-feedback and the imagery and the… Those of you who’ve pursued migraine relief for even a short period of time can relate. Then gradually, the medical and pharmaceutical communities took notice of our disease. All of a sudden several clinics popped up specializing in headache or the all inclusive “pain”. Pharmaceutical companies introduced headache specific pain meds both prescription and over the counter or, in my ever humble personal opinion, they rebranded existing meds as pain relief for migraines. Health segments on the national news would include migraine reports. Being a capitalist, I firmly believe that market forces enticed enough doctors and drug companies to invest their time and money in finding relief for us. Unfortunately, this also meant more and more people were having headaches (hence the larger market for remedies). If not more sufferers, then more people were complaining about the pain and seeking medical help as opposed to living with it. All of a sudden, relatively speaking, “headache” became accepted as a more legitament medical complaint and big business.

With all this new attention to giving us sufferers relief, how many of you can raise your hand and shout “Yippee! I am now pain free!” If those I have talked with over the years are any indication, the answer is “not (m)any”. Migraine remains one of the most elusive medical problems to cure. As Siri Hustvedt wrote in the New York Times, “Migraine remains a poorly understood illness.” (http://migraine.blogs.nytimes.com/2008/02/07/?scp=1-b&sq=SIRI+HUSTVEDT&st=nyt) With all the medications doctors have tried on me for prevention (seems like the entire PDR), nothing has provided positive lasting results. Nada. Zero. If I asked for a show of hands for migraineurs with a similar experience as myself, I’d imagine a lot more hands than “pain free” would raise. Indeed, because of my “resistance” to preventative medications (don’t you just love how some in the medical community blame the patient?), I’ve been offered permanent disability. When this happened to me many years ago, I immediately fired the doctor explaining I wanted help to function and be productive, not quit. But now what? What was my game plan now? Where/who do I go now? In my mind I had done it all. I didn’t want to start all over again with a doctor would simply redo all the procedures I had already been through. In my medical travels, I quickly found that each practitioner would have me do the exact same “spool up” as all the rest which, of course, did nothing for my pain relief in the months it took. I wanted HELP. When I asked for pain relief, I was, maybe, offered Tylenol® 3 (sometimes 4) or perhaps Vicodin® (sometimes ES) along with the lectures about how I couldn’t be taking these medications for long. “OK”, I said, “but what long term pain relief?” I would ask. I’d get no response. This was before the internet really took off, so my research was limited to medical books and professionals that would talk to me about long-acting narcotic pain medications. Narcotic! So there was the rub. Ah-ha! Now it all made sense. There were doctors who were personally adverse to narcotic therapy and, if they said that up front, I respected them and their opinion. But it was the ones opposed that would keep bringing me back, charging me, and never quite get to the point where they would “try” it that I had a problem with. Interesting side note: a well respected Indianapolis area hospital has just opened a Headache Center (excellent!) and says right up front in its web page they do not use narcotics (http://www.stvincent.org/about/news/pressrel/SVH-Carmel-Hospital-Opens-Headache-Center.htm). That I can deal with as I know the game plan going in. Then there’s that government regulatory agency factor. Doctors have told me they wouldn’t prescribe a long-acting narcotic even if they knew it was in the patient’s best interest because they don’t want the government “interference”. Sad. Fortunately, in my case, I found a doctor who did their (and my) “due diligence” and prescribed a long-acting pain medication. And yes, it was a narcotic. End result? I got my life back. My family got their husband and dad back.

So, where is this rambling screed going? The good news is: there is positive movement in the migraine world. More options are available. Physicians are taking notice and drug companies are trying to provide good preventatives. The bad news: We have a long way to go and must never forget the personal responsibility we each have in making sure our treatment is appropriate for our own individual needs.

Disclaimer: My only expertise in headache/migraine pain relief is that of a sufferer/patient. I am not a medical doctor nor have any medical training or expertise. Nothing in this article should be taken as medical advice.