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Fight Petition to Eliminate Opioid Treatment

A radical group of doctors and law enforcement have submitted a petition to the FDA that would effectively eliminate treatment of chronic pain with opioids.  The maximum treatment would be 3 months and the amounts prescribed very limited despite the amount of pain suffered or the amount of medication you currently receive.  You may read the petition here: http://www.citizen.org/documents/2048.pdf
And respond to the FDA here: http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001
In your response you need to note how much the pain medications help reduce your pain and how they have improved your function.  This is a very serious petition and will impact pain management across the country if it is enacted, causing millions to suffer.
36 Responses
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3184829 tn?1344691676
This is rediculous
Helpful - 0
1855076 tn?1337115303
This is certainly not ridiculous.  My own primary care mentioned that all of this will start in 2013, beginning with state-aided insurances followed by insurance companies like BC/BS and then it will trickle down.

This is very serious for those with long-term chronic pain.  Because of the rumors of this, I have tapered off my medications with the result of the quality of my life decreasing significantly.

To the OP:  I was unable to find the petition to sign for this.  If you have a better link, could you please list it.  Thanks.
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3184829 tn?1344691676
Sorry, That came off wrong. I'm in complete agreement with you. What I meant is, how absurd this is for legitimate pain sufferers whos quality of life is being stripped from them. I should of elaborated.

I fall in this category but I do not reside in the U.S.

All the best,
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Avatar universal
http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001
Try cutting and pasting to your browser...try either the entire line or beginning at www.
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1855076 tn?1337115303
Guess I'll have to keep trying.  I keep coming up with document does not exist.  This worries me greatly.  No one should suffer terrible chronic pain.  My own doctor has mentioned the changes that will be happening as of 2013, which is one of the reasons I have tapered down.  Truth is, now I have days I can barely get out of bed.  Everything is a Herculean effort.  But I don't want to go back on the higher dosages and then have to go through the withdrawal I've already gone through.

I'll keep trying!!!  Keep spreading the word.  These new laws are going to affect a great number of people.  And by the time they realize it it will be too late.
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3184829 tn?1344691676
Marycarmel: Are you using firefox or IE ?

http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001

Pasting  that link works for me using Fire Fox. Give It  try If not already.
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1331804 tn?1336867358
You have to click the "comment now" button in the upper right corner.  I will post my comments on the petition when I have some time. Mary, I got your pm and will respond to that as well. Essentially doctors will still be able to prescribe off label but the hope from " prop" is that the labeling changes will curtail doctors from prescribing opioids for chronic pain. I submitted my comment last week.
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1326416 tn?1370927001
I hope we are all "grandfathered"  out of this ludicrous idea.
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1855076 tn?1337115303
I'm using Safari.  And I'm somewhat technologically challenged!
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1855076 tn?1337115303
I was able to sign the petition and comment.  However, I couldn't figure out how to read others comments.

Additionally, how can we spread the word on this?  Sadly, this forum isn't filled with a lot of the old regulars and at times can be slow.  For those of us with chronic pain, things are looking bleak. I know Massachusetts is planning changes that will eliminate chronic pain patients from receiving narcotics in 2013.  It will begin with state-aided insurance and supposedly BC/BS and then followed by other insurances.

I feel this is criminal.  Though I have gone to an as-needed basis to sort of see where my real pain is, there are days I couldn't get out of bed without my meds.  I want the option of what I need for my condition.

Additionally, my 84 year old dad is now on a long-acting med plus a small dosage of oxycodone 3 times a day.  He had been in agony after a crushed vertebrae (Which did resolve after surgery) but then had a stroke, which affected his leg and of course then his back.  I dread thinking of his final years spent in pain with no quality of life.
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1331804 tn?1336867358
Hi Mary I just got my first smartphone this weekend so I am using that during the week now to mostly catch up on reading posts. So I know what you mean about safari LOL!! :)
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Avatar universal
femmy29- You are absolutely correct. The purpose of the FDA petition is reduce overprescribing by placing limits on the claims that drug companies can make... it's to prevent aggressive advertising for long-term use and high doses because this type of prescribing is riskier. The petitioners are NOT saying that nobody should receive long-term opioids. Several of the petioners are respected pain specialists who prescribe long-term and high dose opioids.FDA regulates drug companies, not doctors.

Like me, backpain1955 is brand new to this site. He signed up for the sole purpose of scaring patients on opioids so that they'll submit comments to FDA against the petition. His claim that the petition will lead to a ban on opioids is totally false. To understand the petition, please read:
http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3674
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Avatar universal
Only the naive could possibly conclude that this petition would not lead to a ban on opioids.  The petitioners are saying 1. there is a 100mg limit on medication and 2. that medication should be given only 3 months.  Chronic pain by definition begins after 3 months.  So chronic pain would be eliminated from opioid prescribing.  The assertion that this is simply a mere suggestion in the package insert is ludicrous given the state Medicaid and insurer adoption of the exact language in drug package inserts are being used to determine payment for medications.  A person needs more meds outside what is in the package insert- too bad.  Many of the major insurers are now simply denying payment for anything above what is written in the package insert.  Medicare itself (not the companies administering part D) has started enforcing this in some areas.  And then there is the issue about doctors prescribing "off label" which the naive misanthropes at PROP contend is not an issue.  It is a huge issue.  Ask your doctor if they would prescribe Actiq for you for non-cancer pain.  The vast majority will not because it is "off label" and they are risking their license by doing so.  This era of hyperregulation of opioids by states have doctors running scared and most are not going to snub the regulators that control their medical license to practice by prescribing opioids off label.  Don't believe the backpeddling nonsense put out by the extremists at PROP that don't have a clue as to how the real world works.  I guarantee passage of this absurd attempt to stop opioid deaths by cutting off all opioids via the back door will injure and torture chronic pain patients.  Ask the pain patients in Washington state how they are enjoying restrictions on the opioids prescribed and you will get an ear full.  
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1855076 tn?1337115303
I was told by my primary care, whom I respect tremendously, that beginning in 2013 in MA that narcotics were going to begin being used only for 4 reasons.  Two were things I never heard of.  One is metastatic cancer (odd, couldn't a tumor that hadn't spread cause horrific pain?) and the other is post-op pain, and that will be limited to two weeks.  Supposedly this will start with state-aided insurances and then likely Blue Cross/Blue Shield and then others will follow.

My PCP is very knowledgeable.  She prescribes my pain medication.  I tapered off over a year period, basically because I didn't like the side effects, my pain wasn't effectively controlled, and I was on so much at such high doses I was afraid that at some point they'd never control my pain if I had something seriously acute occur.

Right now I do as needed.  I'm deciding whether to go back to a new pain management program or to stay where I'm at.  I don't want to ever taper like I had to before.
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3184829 tn?1344691676
We all need to get the word out to fight this!
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3183999 tn?1344645418
I found a site that states the following:

Here is the crux of their argument -
"The petition calls for changing the labels to eliminate the word "moderate," and to include a maximum of the equivalent of 100 mg a day of morphine and a time period of no more than 90 days when used to treat noncancer pain."

However, it went on to state -
"The changes would not affect a doctor's ability to prescribe off-label, just such promotion by drug companies, said Sydney Wolfe, MD, director of the health research group at Public Citizen."

"The label change setting the maximum dose at the equivalent of 100 mg of morphine means that it would apply mainly to higher doses of the drugs, which also are the most dangerous, said Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing.  That's about equal to 14 tablets of Vicodin or 13 tablets of Percocet a day, said Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn. Someone taking twice-a-day, 80 mg of Oxycontin, which is made by Purdue, also would be over that limit, he said."

Here is the link:
http://www.medpagetoday.com/PainManagement/PainManagement/33900

I currently take Vicodin 7.5/750 3x daily for my fibromyalgia and chronic upper back pain, so the changes would not affect me.  However, I know it WILL affect many others who have to deal with more intense pain/conditions than I do.  

OH - and there were only THIRTY SEVEN doctors/watch group representatives who signed the petition presented to the FDA for consideration.  So, I don't know if they really have enough pull to get the changes made - especially when the pharmaceutical companies will be fighting it every step of the way!!  For once I am HAPPY for the billions of dollars that the drug companies have for lobbying!!!
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Avatar universal
The group consists of out of touch academics that use residents or other doctors to do the actual patient care.  These are elitist think tank wonks that either don't care, haven't a working knowledge of real world medicine, or are completely insensitive to the suffering of pain patients.  Their allegation that these changes will not affect a doctors ability to prescribe is not only naive but demonstrates a dangerous lack of knowledge about insurance rules and the current regulatory environment.  These changes absolutely positively will result in absolute maximums being imposed by insurance and by state medical boards.  
Helpful - 0
Avatar universal
I just commented on that petition. I don't even get medications for my awful pain yet and I know this is the worst idea ever.

90 day limits for those with CHRONIC pain? Is that a joke?
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1331804 tn?1336867358
This petition calls for drug makers of opioid medications to strike the term "moderate" from the labeling and only specify the medication for severe pain.  Additionally, they request that the label state that the medication is only for use for up to 3 months in cases of chronic non-cancer pain (CNCP).  Lastly, the petition requests the use of no more than 100 mg of morphine equivalent dosing per day, which is not very much medicine when tolerance begins and requires an increase in dosage to achieve the same initial pain relief.

This labeling essentially strikes recommended use for CNCP patients as acute pain is deemed chronic after it persists for 3 months.  So once the pain shifts over to chronic pain, all of sudden the labeling suggests that it is no longer appropriate for you.  I completely disagree with the approach that the Physicians for Responsible Opioid Prescribing (PROP) are taking to curb Prescription Drug Abuse in America.  If this petition is accepted and adopted by the FDA, it WILL hurt pain patients.  Even though doctors will STILL be able to prescribe the medications off-label, the new labeling will curtail doctors from prescribing and make them think twice before begin opioid treatment for chronic pain.  

Off-label for example: Neurontin (aka Gabapentin) is an anti-convulsant prescribed for the treatment of epilepsy but many doctors prescribe it off-label to treat neuropathic pain as it has been shown effective for the treatment of those types of conditions.  Prescriptions for opioids after 3 months would be considered off-label prescribing.  Additionally, prescribing more than 100 mg of morphine equivalent would be considered off-label prescribing as well.  

To give you an idea of how much 100 mg of morphine is in terms of oxycodone, it is about 60 mg of oxycodone a day.  The issue with the morphine equivalency limit is that there are various conversion factors out there for converting from one opioid to another.  Some conversion tables suggest that oxycodone is 2 times stronger than morphine but that includes a factor of cross tolerance which carries the assumption that a lower equivalent dose will work for your pain as your body isn't used to the new chemical but not all people respond well to conversions that take into account cross tolerance and because of that, many end up with withdrawal symptoms.  Without cross tolerance factored in, oxycodone is about 1.5 times stronger than morphine.  So work would need to be done to adopt a universal conversion table to make sure everyone on the same leveling plane as between the two strength conversions of oxycodone, there is a 10 mg difference in oxycodone allowed per day based on 100 mg morphine equivalency.

There is also the possibility that the label change could change what, when, and how much insurance will cover for opioid medications when they are prescribed off-label.  We all know that it is nearly impossible to get insurance to approve Actiq or Fentora for the treatment of non cancer pain as the label states "for the treatment of cancer pain".

The key flaw of this petition is that currently there have been no clinical trials of opioid treatment past the 3 month mark as the FDA has only required 12 week clinical trials for drug approval.  So currently there isn't any accurate medical evidence that shows opioids effective after 3 months so there is no way to argue to the FDA that opioids are unsafe or ineffective after 3 months.  And many of us here at MH have been taking our opioid medications for a year or 5 years or longer and can testify that the medications are still effective.  So this petition is VERY premature and the evidence presented by PROP is shotty (at best) so it is very likely the FDA will tell them to do more research and come back with more accurate claims.

I have submitted my comment to the petition on the FDA website and I encourage all of you to do the same.  They will read all of the comments at the petition hearing and they do take the public's grievences into consideration.

There are many doctors and pharmacists that are against this petition and are working very hard towards a denial of the petition by the FDA.  There are several websites below that you can visit to read an excellent dissertation against the petition and a blog where doctors and pharmacists are going head to head on the issue.  And yes, you can post your comments on the blogs on both the websites I listed below.

In all honesty, I would not be too concerned about this petition getting passed by the FDA.  The FDA rarely if at all acts on the request of these types of minor petitions that they receive frequently.  However, this petition is just the beginning of a movement against the treatment of chronic non cancer pain with opioid medications so I recommend that all of us remain vigilant and when future changes make their way to the FDA or DEA for approval, we need to make our voices heard.  If they don't hear from us, they will think that we either accept the proposed changes or just don't plain care either way.

I will say that I have a fantastic PCP that I know will still prescribe my medications off-label and at the dosages required to control my pain but I posted my comment to the FDA to support all chronic pain patients out there that are following the rules and are undertreated or not treated at all.  As I know, I was in that position awhile ago and it isn't a fun position to be in.  Especially, when you have a career to hold down along with being parent to children.  

So just to make it clear, I am completely against this petition.  Limiting access to opioid medications for chronic non cancer pain is not the answer to the prescription drug abuse problem in America.

Here are the website links:

http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html

http://paindr.com/label-changes-for-opioids-for-or-against/

You can view your comments by clicking the link next to the "Docket ID" on the website below.  Next check the box that says "Public Submission" and the comments will load up in the box below.  I have posted a link to the website where you can view your comments directly.  It does take some time for your comments to be posted, so check back frequently.

http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=25;po=0;D=FDA-2012-P-0818

femmy
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3183999 tn?1344645418
You wrote:
"I've been Nurse 12 yrs & have treated u guys, u rely on way too many meds and that's why there trying to outlaw it, it's all in ur mind quit whining to ud doctor & get a job and quit popping pills, it crap when u do what's asked and follow instructions we get in trouble cause of u all"

Who are you talking to?  You are here because you, too, take prescription pain killers.  Is your pain all in your mind?  I can tell you, mine is NOT.  Do you rely way too much on your medications?  I don't - I balance the pharmacology approach with exercise, proper nutrition, and lifestyle choices.  

Also, what makes you think that everyone else here is sitting around, NOT working, and just "popping pills"?  I take care of my three children, have a great relationship with my husband of 14 years, work part-time as the Coordinator of Religious Education for my church, volunteer at my kids' school several times a week (I am the Room Parent for both of my elementary-aged children, on the four person Academic Booster committee for my middle schooler, and I ride the bus to EVERY field trip for all of my kids), and I actually LIVE with my pain...I do not just suffer through it.  Pain management makes that all possible.

I do not "whine" to my doctors.  I have to say that as a nurse, your approach to chronic pain patients worries me.  You are hostile here to people LIKE YOURSELF.  I am sure you HAVE had terrible experiences dealing with drug-seekers.  But, because of those, I would think that you would understand why those of us who do NOT drug-seek hate the label.  If anything, I would think you would be happy to meet people like us - people who are in the same boat as you and ARE responsible about our healthcare.  

You also wrote:
"if u take more than 3 different pain meds& still need something to sleep or for anxiety u r also 1 of the **** ups"

Wow, that's pretty harsh.  You can thank God that you DON'T have a panic disorder...but I do.  I take Vicodin 7.5/750 (3x daily) for my chronic pain, along with Savella (an anti-depressant specifically designed and prescribed for people with fibromyalgia), Lexapro, and my Xanax (4x daily) for my panic disorder with agoraphobia and anxiety.  In addition, I have promethazine (50mg 3x daily) for the intense nausea associated with my pain and chronic migraines.  It also works as a symbiotic drug, helping the pain medication work better.  My pain and my anxiety are closely linked.  My psychiatrist and my physician confer regarding my treatment because of this.  

I'm sorry you have become so jaded that you cannot see that there are LOTS of people out there who DO follow their pain management plans.  Maybe through this site you can see that WE are NOT your enemy...and that the same may be true for your patients.  The nurses at my physician's office, my psychiatric center (my therapist is located there, as well), and my pain management clinic are, for the most part, absolutely wonderful.  They know me and they know what kind of patient I am.  They are my advocates when my regular doctor is gone and the doctor filling in is not familiar with my case.  They genuinely care about me and I appreciate them immensely.  I hope you are able to be that person for the patients under your care.  

My mother worked as an LPN for most of my life growing up (she now works in the school system - but she has always kept her license updated).  She is the one who taught me that the BACKBONE of any medical facility (be it a hospital, a nursing home, a physician's clinic, etc...) is the NURSING STAFF.  And she is right.  

Peace & Blessings to you.

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Avatar universal
hello tuesday:   i was going to respond to envy (envy   ab   i think gives us all a hint that this nurse is "special " and qualified to judge others) and also seems to relish doing so. But! you said it all to her so much better than i could. thank you tuesday for being an active parent connected to the school and children as that is the highest calling.  shanti shanti shanti    om
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3154531 tn?1343432389
well said tuesday. envyab sounds like another "nurse" who floats on these boards. my guess she has changed her "handle" based on her text speak responses just to get a reaction. i pay her no mind. take care..
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3183999 tn?1344645418
Thank you to Omhome and Lacf58 :),
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Avatar universal
The American Academy of Pain Medicine released a letter to the FDA on the PROP petition, and are asking the FDA to jettison the Prop petition because of a number of false assertions by PROP
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