Wednesday, November 29, 2006

FDA "ADVISORY" AND MANUFACTURER’S “PATIENT INFORMATION” STATEMENT ON METHADONE FOR PAIN - FAR TOO LITTLE, FAR TOO LATE

On Nov. 27, 2006, FDA issued an "advisory" on methadone for the management of pain. It and the associated new "patient information" issued by Roxane Labs actually divert attention from the only major change that has recently been introduced: a marked reduction in "usual" starting dose from a maximum of 80mg to a maximum of 30 mg per day.

Neither the FDA Advisory nor the manufacturer's information sheet makes any reference to any specific dosages - let alone is there mention of the dramatic reduction in what is considered to be an appropriate "usual" starting dose. It's hard to imagine why, since this flurry of activity is clearly in response to the recognition that 80 mg on day one is potentially lethal. One would imagine banner headlines on both documents proclaiming 30 MG METHADONE IN FIRST 24 HOURS TOP OF THE RANGE FOR INITIATING TREATMENT FOR PAIN; HIGHER DOSES CAN HAVE FATAL OUTCOME. Sure, one would want to leave flexibility to the individual practitioner - but the generalization of high, potentially fatal, risk should have been highlighted and extreme caution urged before exceeding the “usual” range. Instead, as noted, dosages were not even mentioned! What did receive great attention, as reflected in the very title of the FDA advisory, are references to allegedly life-threatening "heart beat" irregularities, though we have been unable to identify a single report in the professional literature of any death attributed to methadone-induced cardiac effects.

So where does one find the dramatic new dosage references? Only on page 15 of a 17-page, very fine print, comprehensive, description of methadone (Dolophine, to be exact). There, under the heading "initiation of therapy in opioid non-tolerant patients,” is written: "...the usual oral methadone starting dose is 2.5 mg to 10 mg every 8-12 hours slowly titrated to effect." Until now, the same section read : 2.5-10 mg every THREE TO FOUR HOURS. Thus, the top of the range for initial management has been reduced from 80 mg to 30 mg – but no hint of this very substantial reduction is alluded to by either FDA or Roxane.

Clearly, the "advisory" and "patient information" notices are far too little in not spelling out up front precisely what new message must be heeded to protect patients. The notices are also far too late - certainly, too late for some of those patients who may have been prescribed the previously noted "usual" doses, and/or who relied on the FDA-approved "package inserts" that spelled out the same total day one range of 15-80 mg, and who may have suffered an overdose as a result. Note that a 2003 study (Ballesteros et al, JAMA, July 2, 2003) of deaths "due to methadone" in North Carolina, reported by CDC, found that of almost 100 patients for whom information was available "75% had been prescribed methadone by a physician." One can only speculate whether at least some of these deaths might have been avoided had the "usual" dosages specified by FDA and the manufacturer been consistent with what has been known for decades. Indeed, FDA itself puts a 30mg day one limit on starting doses of methadone for opioid-dependent (and thus opioid tolerant!) individuals beginning maintenance treatment (see, for example, the US Department of Health and Human Services “Treatment Improvement Protocol TIP 43," 2005, p. 67; and also the 1999 Federal Register, July 12, 1999, vol. 64, number 140, p 398401). The evidence regarding initial methadone dosages that are least likely to cause serious adverse effects is massive, consistent and worldwide; it was embodied years ago in the clear and concise Province of Ontario methadone maintenance guidelines: "START LOW, GO SLOW".

9 Comments:

At 10:47 PM, Blogger Melis11577 said...

I am writing on behalf of the victims and those yet to be victims of methadone. I have come together with many other families throughout the United States who have lost loved ones to methadone.

We are asking government agencies to enact stricter guidelines in prescribing methadone for any reason. It must be mandatory that all doctors be certified and trained in the pharmacology of methadone; inpatient stays must be required during induction to methadone; all staff be extensively trained in monitoring methadone patients for symptoms of toxicity. Clinic patients should be tested for legal and illegal drugs that are taken with methadone to get “ hi gh” of experience “euphoria” such as benzodiazepines, alcohol, cocaine, heroin ect… and face severe consequences / mandatory detoxification from methadone program when presenting inebriated at clinic, clinic should also document such activity as well as prevent client from driving. Take home doses for all patients receiving methadone should be eliminated thus preventing the risk of diversion or precautions such as pill safe should be implemented. http://www.thepillsafe.com/

Current statistics show that nearly 4000 people a year die from methadone. These deaths are mostly happening to pain management and detoxification patients wit hi n the first 10 days of taking initial dose. Most of these deaths are related to methadone prescribed with other medications that react as additives with methadone. Diversion of methadone is a serious problem because it lands t hi s most deadly drug on streets. Statistics also state that methadone is contributing to more deaths nationwide then heroine and cocaine.

The government did take notice after the 2003 record number of deaths associated with methadone and the Bush administration responded by gathering the top experts on drug overdoses, doctors, researchers, and medical examiners, as well as representatives from the federal Drug Enforcement Administration, Food and Drug Administration, and Substance Abuse and Mental Health Association. Finn and Tuckwiller (2006) report that “the man hired to research and write the report based on the conference, as well as background paper for conference participants, was Stewart B. Leavitt, and addiction specialist whose work is funded by the makers of methadone”. Stewart B. Leavitt PhD served as researcher/writer for A National Assessment of Methadone-Associated Mortality: Background Briefing Report from the U.S. Department of Health and Human Services. Stewart B Leavitt also writes Addiction Treatment Forum Methadone Dosing & Safety in the Treatment of Opioid Addiction which is funded by Mallinckrodt, Inc. a manufacturer of methadone. My question is why hasn't a team of independent researchers not funded by pharmaceutical companies; a person or group of people that stand to gain no financial benefit on the outcome of the studies been hired to conduct the research? Finn and Tuckwiller (2006) report that “the man hired to research and write the report based on the conference, as well as background paper for conference participants, was Stewart B. Leavitt, and addiction specialist whose work is funded by the makers of methadone”. Stewart B. Leavitt PhD served as researcher/writer for A National Assessment of Methadone-Associated Mortality: Background Briefing Report from the U.S. Department of Health and Human Services. Stewart B Leavitt also writes Addiction Treatment Forum Methadone Dosing & Safety in the Treatment of Opioid Addiction which is funded by Mallinckrodt, Inc. a manufacturer of methadone. On the forum associated with his website several of the clinic participants speak of diverting, misusing, stockpiling, selling, and potentiating methadone and other prescription drugs.

This methadone epidemic and deaths associated with it are not going away. It's only getting worse; I get contacted by families on a daily basis who have lost someone to this drug. At what point do we value human life over the convenience of others? Methadone patients, whether they are pain or clinic pose a risk to themselves and society as a whole if they are not monitored, dosed, and assessed correctly. Clinic patients getting into cars after being dosed who are using benzodiazepines, alcohol, or other opiates are killing innocent people on the road. This type of harm reduction is not saving lives it’s taking them. The government cannot continue to be a legal drug dealer in order for its citizens to “behave”. Many MMT patients claim that they have been able to maintain sobriety for long periods of time (several years) but are unhappy and depressed therefore seek out MMT and describe the "high" they get from this that makes they happy. Endorphin Deficiency is another "off-label" use of methadone. I have yet to be able to find this "diagnosis" listed in the DSM IV but I'm am sure they a large percentage of the population suffer from this as endorphin deficiency precipitated not only by opiate abuse but also eating disorders, ADHD, low levels of neurotransmitter GABA, PMS, stress, MS, depression etc....
I know the rules are in place for the clinics but they are NOT being followed. Patients sell take homes outside the clinics. In one news article a man died in the parking lot of a clinic after taking his brothers take home. This drug is too dangerous to be allowed in medicine cabinets! There is A LOT of money to be made from methadone but what expense is that money being made at? When do the risks outweigh the benefits of this drug? How many more people must die before changes are made that actually save lives?
http://www.thepetitionsite.com/takeaction/472711451
http://www.actionstudio.org/public/page_view_all.cfm?option=begin&pageid=7555&tmode

On June 24th 2006 I lost my fiancé (Ron) to t hi s deadly drug prescribed by a physician with a combination of other medications that acted as additives to the Methadone. He had knee surgery and became addicted to the percocet he was prescribed. He checked hi mself into Greenleaf in Valdosta , GA for detoxification. Upon entering the facility he was drug tested and did not come up positive for opiates (he had stopped taking the percocet 4 days before entering the facility). On the fourth day in detox he died sometime between 2am and 1pm in the afternoon (he was never checked on in all of those hours). The night before he died he was complaining of migraines and vomiting, apparently the staff thought he was still experiencing withdrawals and was not concerned about these symptoms. The symptoms of methadone toxicity mimic withdrawal symptoms physicians and staff must be very cognizant of the complex properties and metabolization of methadone. There were many errors made in my fiancé’s death including the fact that he was given numerous amounts of additive medications such as benzodiazepines. He had only been taking percocet for about 4 months and according to the DSM IV he wouldn’t be an appropriate candidate methadone maintenance treatment.

It doesn't matter specific reasons for taking methadone but what does matter is that t hi s medication is deadly and physicians need to more prudent in prescribing it as well as monitoring their patients w hi le beginning treatment of any kind using Methadone. I'm not sure if Ron was given methadone for the sole purpose for detoxification from opiates or if it was a combination of pain relief associated with numerous surgeries and opiate addiction. Methadone is difficult to properly dose no matter what reason it's being used for and primarily relies on the patient’s indications of how they feel (assumedly they are being monitored). There are ways to make the administration of methadone safer, it's just a matter of putting the focus on t hi s drug and the deadly consequences when administered incorrectly or not monitored.

Many people are dying unnecessarily at the hands of the physicians they turn to for help. Methadone deaths are rising throughout the country. Ron was 32 years old and has 2 c hi ldren from a previous marriage that now do not have a father.


I'm also providing you a link to a website I created in hi s memory to give a more human touch to t hi s email. http://renato-capozzo.memory-of.com/

 
At 1:59 AM, Blogger B. Keith Phelps said...

This is an old post, so I doubt the last writer of a post will read this, but we clinic patients (at least in North Carolina, and the clinics in VA owned by the same company) DO have to take our takehomes home in a locked box. It's not the PillSafe box, but nonetheless... The problem here is multiple: for starters, this drug SAVES many lives, returns many lives to normal (or as close as possible), and eases much suffering at a very low price that no other opiate can compare to. And of course, like every other opioid, it's dangerous, and deadly if taken by non-tolerant people. That being said, however, I have to disagree that it's too dangerous to be in a medicine cabinet at all (unless you just mean it should be locked up). The truth is that if I'm a teenager looking for a buzz with a deviant friend, or whatever the case may be, and I see the little "May cause drowsiness" sign on a bottle, which is all most of the younger people know to look for, I could EASILY grab my grandfather's high-blood pressure medication, pop 3 of them for a buzz, and go to sleep a half hour later, never to wake up again from hypotension. Kids that want a buzz will stop short of nothing to get one. We can't chicken out of treating people with the proper medicines just to avoid the teenagers that are (I hesitate and apologize for the use of this word, but...) ignorant enough to take meds that aren't prescribed to them - particularly opioid analgesics of any kind. If they get hold of some fentanyl patches, they are almost as likely to die, if not as likely. The reason there's not more of these deaths is that these patches (called Duragesic) are prohibitively expensive, and on the top level tier of most insurance, if covered at all. We're talking ~$700+ for a month's worth (10 patches). Addicts will cut open the patch and eat the gel inside, bypassing the extended release that should happen over a 3 day period, and risk their lives in a big way! I have two young, beautiful nieces that are 3 and 6, and I am on methadone after fighting for a decade to get clean from prescription pain meds and eventually heroin and relapsing over and over and over until I went to prison for prescription fraud, and 6 inpatient treatment centers, all to no avail. NA/AA works for many, but I was not so lucky. One might say I didn't work the steps properly, but I've never NOT admitted my powerlessness over opioids since the first month I was on them... I knew right away that I had a BIG problem because I fell off a cliff when I came out of surgery on morphine and was sent home with Percocet, then Vicodin, then Darvocet, and then cut off. I then found a supply from the "street", or "friends" that had some (of course they weren't my friends in reality...) Now, that being said, I would go to the ends of the earth to protect my baby girls (nieces) from being exposed, tempted to try, accidentally ingesting, or otherwise, and drugs they aren't prescribed (controlled substances or not), including methadone (and especially methadone). I get two weeks' worth of takehomes at this time, and qualify for a 28 day supply starting next month. However, I keep every single pill locked in a VERY heavy safe in my home, and I do not sell a single one, give one away, and we tolerant clinic patients (besides those that might use illicit drugs without clinic knowledge until a urine test shows it) have been proven by decades of tests to show that we don't have slowed reaction times in tests galore, including driving a car. And it may give some people ammunition if they opt to take this statement the wrong way, but the obvious thing is that when an addict enters a methadone program, wanting to really get clean, there's still that little portion in this person's mind that the feeling of opioids is great, and they hate to part with it. Therefore, I'd be a liar to say that at least for a while, it used to really piss me off that when they got me to the right dose for me that cut my cravings, and made me able to abstain totally from illicit opioid use (I don't drink or use other drugs at all - I had tried them in the past, but don't care for them then or now,) that I didn't get any feeling from the methadone that resembled an opioid buzz. Yes, I can honestly say that at first, I wanted to feel the methadone, and couldn't. It was like I might as well have been taking a sugar pill each morning. But the point was not to get a buzz, and if I was EVER going to get clean, I knew I had to want to quit worse than I wanted to use illicit opioids. So I continued to be honest with my doctor and counselor, and kept up the program like I should, and stayed on a significant dose for 3 years (150mg), until I felt I had been away from thinking anything about drugs for long enough to try moving back down some. I then slowly moved down 5mg a week to 80mg, where I am now. I stopped at this point, because for now, I had to listen to the fact that my body was telling me that I needed to let it catch up for a while, so I am sitting here at 80mg. Will I ever quit taking methadone? I can't say. That would be a dream come true! To not need it; or have to pay almost $300/monthly for it out of my pocket? Wonderful! But am I willing to risk going back to prison in order to detox from it immediately in the vain hope that it will somehow be for the betterment of mankind? No. Sorry. Because I'm not distributing a single pill to whatever street market might be operating. And I resent that anyone would suggest that any addict, regardless of where the blame lay for the beginning of the addiction, should give up his or her recovery in order to keep a group of curious teenagers looking to get a buzz or adults for that matter, who aren't prescribed methadone, from taking it and killing themselves. That might sound uncaring or selfish, or it might sound downright flippant - but I guarantee you it's not. I truly care about each and every human being in this world and wouldn't dare wish addiction or death on anyone, friend or foe. BUT, I know that the truth is that if the methadone clinics all close, and we take methadone from the pharmacy, then the new Opana (oxymorphone) tablets just approved by the FDA, which are stronger than OxyContin, and are capable of being injected, according to the very prescribing information that comes on the packaging to the physician (go look at www.opana.com if you don't believe me), will take the place of it... or OxyContin will continue to be abused, but even more... or Dilaudid, Demerol, Percocet, Vicodin, you name it... people will find a way to get what they are after, and that's just a sad fact of addiction, and life in general. I didn't know about these Opana tablets until a couple of weeks ago, when I saw a pen at my doctor's office (not the methadone clinic) that advertized this new pill, which was only available as injectable solution at hospitals until now, and fits into the overall picture like this: morphine is converted to methylmorphine (codeine), which is 1/6th the potency of the original parent morphine. Codeine and other poppy derivatives are converted to the hydrogenated and oxygenated ketones of codeine, which make them about twice the potency of morphine, and are then called hydrocodone and oxycodone, respectively. Now, morphine can also be done this same way, and the hydrogenated ketone has been abused massively by opioid addicts for MANY years, known as Dilaudid, or hydromorphone (about as strong as heroin (maybe a tad more, though it gives more "rush" at first, and less "high" later, and around 4 to 5 times stronger than morhpine. Now, if you look at oxy- and hydro- codones, they are about equi-analgesic... but one is a schedule II (oxy), and one is level III (hydro). The difference is that level II is extremely controlled, versus level III being on the general pharmacy shelf (no lockup in most states; level II is in a safe in most or all states). This is because some lab somewhere, even though the conversion charts for docs tell them to equate the two for conversion purposes (transferring a patient from one opiate to another) in strength, figured that oxy was a wee bit stronger. Thus, it became the tighter controlled and harder to get of the two. Now, consider oxy- and hydro- morphones. They will be several times stronger than morphine, and I haven't tried oxymorphone, since it was only in hospitals until last year, but I'd bet that it's either equi-analgesic to Dilaudid (hydromorphone), or a wee bit stronger. This means addicts are going to have a field day with every opportunity they get. Many will die. Many will get arrested for passing scripts (as I did). Many will use it and will live to tell about it, and wonder what they were thinking years later when they realize what a dumb idea that is to play with this stuff. But I don't want our gold-standard of opioid treatment for 40 years to be taken away, to where there is nothing to offer heroin or painkiller addicts except a room full of other addicts that can all discuss the ways that they used to get high together, or discuss their resentments they've held onto against others, or how they're powerless against their addiction, but then leave that as all that opioid addicts have at their disposal to get back to a normal life. If there is the theoretical endorphin (which was so-named for "morphine within," by the endo [internal] and orphin [morphine] parts being combined) imbalance possible from the heavy abuse of opioid compounds, then there should be a long-acting medicine that corrects the problem available to addicts, so that they can get away from the 24 hour a day, 7 days a week torture of cravings, which you think are just little thoughts that come and go, but are, in reality, the ONLY thing an opioid addict can think about for literally years after his or her last use. All other things are secondary... and that's unfortunate. Because I'd die for my nieces or my brother, or my parents in a skinny heartbeat, if it would save their lives. But I hurt them in my addiction more than any family should ever have to go through for almost a full decade (it was actually 9 years and a little more)... they don't deserve any more relapses, calls from the police station, visits to a prison, or any of the above. The methadone program is the only way I've been able to finally get into college for the last three years for a bachelor's in Information Technology (IT), stay illicit drug-free, stay in the same home of my own for the last 3.5 years, keep my credit perfect, keep my payments made on a new car I bought 3.5 years ago, also, and not talk about drugs 24/7, and constantly obsess about them. I don't deserve to have to be banished back to that life, nor do they. Nor should society have to put up with another addict in their midst that can't contribute anything worth 5 cents because he's constantly relapsing, getting caught in pharmacies or buying on the street, or just basically not able to do anything of value because he's got a constant need in his mind that there's something wrong that won't let him feel normal in his body, which methadone fixes, and it most certainly (again) doesn't produce any high, unless you add illicit drugs (including illicit prescription drugs - which our clinic does NOT allow, including barbiturates, benzodiazepines, alcohol, amphetamines, THC, and so on; and they DO test for it, at least once a month and up to twice a month or more, if suspected use is there.) We can't wear sunglasses in, so that the nurse can see our eyes and be sure they're not glazed over. And yes, for every attempted good thing in the world, there are those that will try to take advantage of it in some way or abuse the system... but that doesn't necessitate or justify taking the program away completely, because that throws away all of the thousands that it IS helping to lead a productive life... which you know very little of who they are, because most of the ones I know, either from my clinic, or from others, don't tell anyone they're on methadone because they're successful, and don't want to be discriminated against at work, or by people that attach a stigma to methadone. Think about it - would YOU want to tell anyone if you were successful on a methadone program after failing at every other attempt you'd made at getting back to a normal productive life like "normal" people have all around you? I can't speak for you, but if I were a betting man, I'd say I doubt it. I've been, and I quote my doc and counselor, "a model patient" (no late payments in almost 4 years, not a single dosing day missed, not a single takehome unaccounted for - they do random call-backs where we have to bring them back for a count, not a single lost dose, attend group and individual counseling as required, et cetera), and I was fired by a boss that had a problem with methadone programs, and she had loved me to death (and knew of my addiction problems) until the day "methadone program" rolled out of my lips, and I saw it on her face when I said the words - I'd been there for two years without a single incident, or write up... I got wrote up four days in a row the following week, and fired on Saturday. You tell me why you don't hear more success stories from clinic patients! Anyway, I grieve for the loss of life from this medicine which has saved my life... absolutely, and without a doubt, and I extend my deepest regrets to those who've lost loved ones to this tragic disease called addiction. And even if you don't believe it's a disease, still, it's a tragedy that people dabble with things that can kill them, despite knowing better. We've all had it drilled into us that drugs are bad, yet some opt to take that risk. How horrible for those and their families that don't make it past the first time, or even those that die after 20 years before finding a way out of the madness and sheer pain of addiction. It's really a heartbreaking cycle. My former significant other said to me one day (with the best of intentions), "Keith, if you want to kill yourself, I've got a gun in the drawer upstairs, and it would achieve the same thing as what you're doing now, but it would be so much less painful..." And that statement was made with the saddest tone of voice, and I knew that I was hurting everyone that loved me beyond words. I only thank God that I lived to get to try to make it up to them by bettering myself with an education, and all of the things they had hoped for me before I had gotten into that mess as a 21 year old young man. Thanks for reading my thoughts, to anyone that did... My prayers are with anyone that is suffering in addiction, and the families of those people, and those families that lost loved ones to drug abuse, whether methadone, cocaine, heroin, weed, or tree bark (not to be funny - but no matter what you have a problem with, if it's ruining your life, it doesn't matter WHAT it is... it's ruining your life... period.) I can only pray for those that have yet to find the answer that will lead them out of their addiction yet... and certainly, methadone is NOT every opioid addict's answer, just as penicillin isn't every infectious person's answer. I don't knock NA/AA - if you need group talk about your resentments, powerlessness over addiction, and learning to live the way they describe (which I feel that I already did and do to this day), then by all means, go there, and get the thing that will help you! And faith-based programs, too. We need EVERY resource we can get... not finger pointing by one group at another about how ineffective the treatment was for the people that tried it and had to move on to something else before finding recovery. Again, that's why we have several different antibiotics... several different antihistimines... several different insulins... chemotherapy, radiation, and you name it. What works for me may not work for you. But I thank my God down on my knees (literally) everyday for allowing me to find the thing that got me away from that junk out there. And if He ever opts to take the desire completely away, and I can taper off methadone, all praise be to Him! If He elects to let me carry this burden until I die, then I will gladly swallow my pill each morning and feel like a normal human being, and interact with all of you at Wal-mart or Best Buy without you even knowing you're talking to a methadone patient... because believe me - you won't know it. And neither will your kids - because I won't be the one to sell or give them any! May God bless you all. Please excuse any errors in typing or continuity in this LONGer than intended response.

 
At 9:53 PM, Anonymous Anonymous said...

I read your post its long ....drug confused . I know I am there too . I want to be normal again after years of Chronic Pain and opiates for treatment . I take 4 duildads a day to 5 now for pain ..sit all day in a chair and function at the level of a mental patient . Doc wants me to titrate down on Methadone ...I cant see it been there long acting agents build up in my body and then collapse me over and over . Mostely loss of gut function leads to collapse with impactions . The bottom line is people have to do what works for them and Doctors as well as people have to understand we are all trying to find a cookie cutter that works for everyone but it doesnt exist . Pray for me . I am praying for you ..there are no athiests in the trenches or opiate madness once that pain gets to you Moma and God are in everyones screams .

 
At 5:48 AM, Blogger xyz said...

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At 8:33 AM, Anonymous Jhon smith said...

Current statistics show that nearly 4000 people a year die from methadone. These deaths are mostly happening to pain management and detoxification patients wit hi n the first 10 days of taking initial dose. Most of these deaths are related to methadone prescribed with other medications that react as additives with methadone. Diversion of methadone is a serious problem because it lands t hi s most deadly drug on streets. Statistics also state that methadone is contributing to more deaths nationwide then heroine and cocaine.

 
At 8:34 AM, Anonymous Bhimashankar said...

this is really a nice post. thanks for sharing. keep it up.

 
At 1:16 PM, Blogger Shanz said...

I am really very happy that I stumbled upon this, it seems everyday I get more frustrated at the lack of understanding and awareness of this drug.

 

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