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Physicians Submitted FDA Petition to Effectively Ban Opioid Prescribing for Chronic Non-Malignant Pain
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An_247125 posted:
There is a petition put forth by an extremist group of mainly physicians that would change the FDA package inserts labeling for opioid narcotics for chronic non-malignant pain that would limit the length of time of prescribing to a maximum of 3 months, would limit the total amount of medication to 100mg morphine equivalents per day (around 60mg oxycodone, 25mcg fentanyl patch, etc), and eliminate moderate pain and lower from being treated with opioids (VAS 1-7). This petition is predicated on the allegation that there is no evidence based medicine proof of opioid usefulness in chronic non-malignant pain, there is evidence of increasing numbers of death with opioid use in the US, and three small uncontrolled unverified observational studies that above a certain dose of narcotics results in an increased risk of death. The problem is that there IS evidence based medicine to support opioids, just not randomized double blind placebo controlled trials which would be impossible to conduct using opioids. Also, the use of observational studies to make policy decisions regarding limits on amounts of opioid prescribed is extremely unwise since these are not high level evidence based medicine and the amount actually taken resulting in overdose was never quantified in these studies, only the amount prescribed.
Their petition is very serious given that many are academic addictionologists and emergency room docs that see only the failures and never the successes with opioid use and some are academic pain physicians that have written in the medical literature about their concerns over opioid use. Effectively, for the sake of harm reduction, the petition would eliminate opioids for chronic non-malignant pain. They try to mitigate this effect by saying physicians are free to prescribe "off label" however given the current regulatory environment, it is very unlikely physicians would risk their license prescribing "off label" for opioid narcotics and less likely that insurers would pay for "off label" usage. Effectively these physicians are trying to use a back door approach to eliminate opioid narcotics for chronic pain. The petition may be found by doing a google search on "Physicians for Responsible Opioid Prescribing FDA Petition" and there are also links available for FDA comment. In your response to the FDA it is suggested you be brief, talk about how opioids are improving your function and giving pain reduction (compared to no opioids) and avoid long discussions about your pain history.
The academic institutions for these physicians are also listed in the original document and you may write the president of their universities protesting these doctor's positions that would bring untold suffering to millions if their petition were granted, and you may wish to contact your US Senators and Representatives to help thwart this radical petition.
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bren_bren responded:
?Heres a link for pain patients to sign there own petition against PROP:

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

Overall I wasn't too concerned since only 37 physicians signed the petition. What I do worry about is those elected officials who have the power to pass legislation. For example: ?Congresswoman Mary Bono Mack?

WE have a say in who represents US.

Also, an article that I found comforting (on Pain Topics Updates website) ?includes the following statement: "The petitioners"019 proposal is a blunt instrument solution based on the faulty premise that this problem will be solved if we only restrict the supply of opioid analgesics to a sufficient degree. "

This article also?has links to?3 studies cited by the PROP petitioners. ?They have been thoroughly critiqued ?in previous Pain-Topics UPDATES.?

If you don't have time to read the whole article, scroll down to: "Statements of Scientific Basis for Petition". There the author, Bob Twillman PhD, addresses those specifics points PROP bring about and critiques each one.?

Here's the link:

?http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html?m=1

Final thought: If there haven't been any valid double-blind studies on the?long-term safety and efficacy of opioids (as the petitioners say) then it cannot be determined that long term use for chronic non-cancer pain is absolutely harmful. They negate their claim by pointing out the LACK of quality research.?
 
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bren_bren replied to bren_bren's response:
The first link I provided will allow you to leave a comment for the FDA. You have to click on the "Comment Now" button in the right corner.
 
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bren_bren replied to bren_bren's response:
Ok, this is ANNOYING, but this site is adding ? Wherever I have spaces. I typed this up because I lost what I wrote 3 times in the little reply box.

THE ARTICLE BY TILLMAN:

http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html?m=1

SORRY FOLKS!
 
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fibrofran17 responded:
Thank you muchly for the specific information and what we as "free" citizens can do about this issue that greatly affect our lives. I've been following this scenario and hope and pray that we can find the best outlets for our united voice in this matter. It's such hypocrisy and a lip service approach up and down the line in the government and the pharmaceutical business and on and on. The FDA is so underfunded and staffed to get a grip on all the harmful prescription drugs and procedures out there, so find a scapegoat for appearances sake so we are a "safer" society. What BS. And law enforcement and hospitals see only what they see, not the forest for the trees. Folks, do what ever you can do to add your voice to this crucial issue,
Blessings to All, fibrofran
 
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trs1960 responded:
I say put the authors of the bill in a room with some of us severe chronic pain patients. Take away all of our pain medications and lock the door ...come back in about 3 days...problem solved. Some idiots assign all mal adaptive behavior to the pain meds and have no clue what side effects severe pain can cause.

In 4 days it may be too late. It's amazing how proper use of opiads can give a person a chance at a quality of life. It still takes a lot of mental and physical work.

I'm in physical therapy 3 times a week working out. My therapyst has a PHD (Masters) in physical therapy. She told me it is likely noting will ever temper my pain except for some amount of opiads. Working out makes me stronger and makes me feel better. I've lost ten pounds and have gained core strentgh. Withouth the pain meds I wouldn't be able to push myself to continue PT.

I ran in to an ex police sargeant today. He works at a sporting goods store and I was looking at some toys. We'd talked a few years ago and he told me about his fusions. He's been shot in the line of duty twice, later he has spine surgery. He could not beleive the amount of pain the spine surgery cuased...much more than the bullet wounds.I told I'd had more hardware installed sinc we last spoke and now I am completely fused from T4-L3. I was smiling and standing pretty straight. He said, "doesn't it bother you!" I told him it hurts like hell every second, but I'm OK.

Healthcare reform my ass!!! We need to let our highly trained doctors do their jobs and cut the insurance companies and legislatures off at the knees. No room for hypocrites.Let those that want to help us have free reigns on how to help us. Some oversite will be needed, but writing each prescription just so the DEA wont take their license is crap! They desrve better and they deserve our support.
 
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PainAdvocate replied to trs1960's response:
The petition isn't a ban on opioids. FDA doesn't regulate doctors, they regulate drug companies. The petition was signed by pain specialists who prescribe long-term opioids. They're only trying to stop drug companies from promoting excessive prescribing.


Off-label prescribing is perfectly appropriate. It just means that drug companies can't advertise the treatment as proven safe and effective.


TRS1960- Hinting at a desire to physically attack the petition's authors suggests that you need much more help than just treatment for pain.
 
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backpain1955 replied to PainAdvocate's response:
The petition is supposed to allow doctors to prescribe "off label" and was designed to regulate manufacturers from over reaching in their advertising. Problem is: the most commonly prescribed medications are GENERIC such as hydrocodone, oxycodone, hydromorphone, and methadone. Generic drugs do not market to anyone, period. Therefore the argument falls apart that the petition purpose was to stop manufacturers from over promoting. The PROP people are not simply pain doctors. They are emergency room physicians, addictionologists, and state administrators that all have an ax to grind with opioids....they see only the down side and never the up side. The argument that such an action by the FDA will not cause physicians to stop prescribing opioids is nearly laughable if it weren't so tragic. The truth is that physicians are running scared from the DEA and FDA, and this action will severely curtail further prescribing by physicians. That is a reality not considered by the people at Prop. Finally, more and more insurers are restricting availability of medications to those prescribed ON LABEL. Several insurers already do this for Oxycontin, MS Contin, etc. Therefore by defining specific amounts available to patients in the labeling of medications will have the completely predictable effect of causing massive reductions in availability in chronic pain patients. This is a fantastic financial boon to insurers since they will continue to collect monthly premiums but no longer have to treat the 100,000,000 in the US with chronic pain. This petition is misguided and naive at best, and at worst will cause an enormous increase in suffering and suicide due to untreated pain.
 
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PainAdvocate replied to backpain1955's response:
Backpain1955- why would state administrators, addiction specialists and emergency room docs all have an "axe to grind with opioids" ?
 
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Anon_973 replied to PainAdvocate's response:
hi all - i've been following the posts -

here's what I have found - I live on the boarder of KS/MO on the MO side. However, my Physiatrist is in KS and since I don't have prescription insurance I have to pay out of pocket. So I go to the small independent pharmacies where they can cut me deals on my meds.

Ok - so I was getting my meds in KS and there had been a couple of pharmacies I went to (one was farther away and other was a little closer) - so last month when I went to said pharmacy he said he could fill all my meds EXCEPT my roxycodone - seems he was RED FLAGGED - which meant by FDA standards and the pharmaceutical company the pharmacies (3 in KS so far) had exceeded the amount that is supposed to be dispensed. At this time I was forced to get these filled at full price at a pharmacy chain.

Once I got home I called 2 independent pharmacies in MO and found they had no problems and the one close to me stated they would have the meds there when I come in. I even gave them the name of the pharmacy in KS just in case they wanted to verify - which they did and have agreed to give me the same price (grateful for that!)

just thought i would let you all know what I have learned -
 
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fibrofran17 replied to PainAdvocate's response:
Pain advocate, WHO ARE YOU REALLY ADVOCATING FOR? just curious
 
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bren_bren replied to PainAdvocate's response:
My opinion: they are the physicians who see the end result. Overdoses, addicted patients, etc.
 
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PainAdvocate replied to fibrofran17's response:
Opioids are only going to get harder to access if something isn't done soon to bring the addiction problem under control.
What Anon_973 described above is happening more and more often. Some pharmacies are simply opting out of selling opioids.

I'd rather see the FDA place some controls on drug company advertising than have laws passed by politicians that get between patients and doctors.
 
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backpain1955 replied to PainAdvocate's response:
There is no argument that we have out of control access to controlled substance medications in this country as a whole. The prescription for the solution is the issue, and it does not involve some hairbrained scheme by a bunch of misanthropes. The American Academy of Pain Medicine today released a very extensive report on the many fallacies of the Prop FDA petition, pointing out why the authors have very little understanding of chronic pain.
The reason ER docs have an axe to grind is that they see only overdoses of meds and drug seekers- not the millions that use controlled substances appropriately. Addiction specialists treat addiction, and usually not chronic pain. Their emphasis in their training is to eradicate opioids since these are "bad" drugs. Administrators would love to see opioids go away since they no longer have to pay for them...
 
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PainAdvocate replied to backpain1955's response:
backpain1955- The American Academy of Pain Medicine gets their funding from Purdue (OxyContin) and other drug companies.
If a day comes where access is totally lost and only people on the verge of death will be able to get opioids- it will be their fault for helping drug companies push opioids on everyone- that's what's causing this mess.
Opioids should be saved for chronic pain patients who really need them instead of being doled out like candy.
The PROP petition is a move in the right direction.



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