My Story: Why Opioid Labeling Changes Are Needed

My Story: Why Opioid Labeling Changes Are Needed

Recently, several columns have appeared in American News Report expressing negative views toward a petition submitted to the FDA by doctors, researchers and public health officials, many of them associated with an organization called Physicians for Responsible Opioid Prescribing (PROP), which recommends certain labeling changes for prescription opioid analgesics.  This proposal, which is intended to reduce harm to chronic pain patients caused by overprescribing of opioids, has met with strong praise and also strong criticism.

It is apparent from reading these columns and the follow-up comments of readers that there are many incorrect assumptions being made about this proposal. As a supporter of the PROP petition, I would like to explain why these changes are needed and why the changes will not restrict doctors from prescribing opioids. I also hope to clear up some misconceptions to promote a better understanding of PROP’s proposal.

First, why am I involved in advocating for the PROP labeling proposal?

In 2006, I lost my wonderful 18-year-old daughter Emily, who was a cancer patient, to a one-time encounter with OxyContin.  In my grief, I began to study the issue and found that Emily’s tragedy was part of a dramatic increase in overdose deaths and addictions stemming from the liberalized use of prescription opioids, which began in the late 1990’s.

I made a commitment to try and prevent other vital young people from losing their lives like my Emily did.  I got involved with some other families from around the country and wound up co-founding the organization of which I am president, Advocates for the Reform of Prescription Opioids, or ARPO.  Many of ARPO’s members have lost a son, daughter, or other family member to opioids, and in a majority of these cases the lost loved one was on a doctor’s opioid prescription for pain.  Other members are fighting a terrible opioid addiction in their family. Most of those cases also began as pain patients.

Before I continue, I would like to say something to the pain patients.  I have the utmost compassion for the pain which you experience in your daily lives.  ARPO does not want to see any individual suffer from pain, and we want to see safer care and better treatment outcomes for those patients who may experience adverse effects from chronic opioid therapy.

We are not attempting to “criminalize” pain patients on opioid medications.  The PROP proposal would not place any restriction on a doctor’s prescribing of opioid medications.  This is the most common misperception regarding the PROP proposal.  Claims that the PROP labeling changes would take opioid medications away from pain patients are incorrect.

Why is a change in labeling needed?

Under the Fderal Food, Drug and Cosmetic Act, before a drug can be labeled for a given use the drug maker must prove that the drug is safe and effective for that use.  Unfortunately, when approved by the FDA, most opioids were labeled for very broad indications, meaning that they were effectively approved for many different types and levels of pain, including moderate and severe non-cancer pain, for which the long-term safety and effectiveness of opioid medications have not been established. This allowed the drug companies to conduct an aggressive campaign to promote the use of these drugs for virtually all types of pain.

The result has been a four-fold increase in prescribing of opioid analgesics over the past decade, along with a four-fold increase in opioid-related overdose deaths and a six-fold increase in addiction treatment over the same time period.  The Centers for Disease Control now estimates that we are losing about 15,000 Americans per year from prescription opioid overdose deaths.

These trends in prescribing and adverse outcomes have been rising in parallel since the late 1990’s, when doctors were urged by the drug companies to more aggressively treat pain by prescribing opioids.  This included, by the way, false claims made by at least one prominent opioid manufacturer that opioids were safe for long-term use. Purdue Pharma was convicted in 2007 after admitting that they lied to doctors about the safety of OxyContin.

Contrary to the claims of some defenders of the status quo, many of the victims of opioid-induced overdoses, addiction or other disorders are pain patients.  One study found that 35 percent of outpatients undergoing long-term opioid therapy at a large health care system in Pennsylvania had developed a lifetime opioid use disorder.

Another study reviewed data for over three thousand individuals who died from an opioid in Ontario, Canada between 1991 and 2004. Two-thirds of these patients were seen by a physician within four weeks of their death and 82% had received an opioid prescription from a doctor the year before they died.

The notion that an addict is limited to those who use an opioid recreationally is incorrect. The addictive qualities of opioids are not reduced by simply writing a prescription. Pain and addiction are not mutually exclusive.

Additionally, many prominent physicians have noticed a gradual decline in function and pain relief in patients on opioid therapy and have come to the conclusion that opioids are not generally effective for long-term use in treating chronic non-cancer pain.  Which is not to say that long-term use of opioids is not helpful to some patients; only that doctors are increasingly concerned that opioids pose high risks and uncertain outcomes when used long-term.

What would the PROP labeling changes do?

PROP’s proposal would make it illegal for drug companies to promote opioids for uses other than those listed on the label.  For non-cancer pain, this would mean drug companies cannot promote the use of a drug for moderate pain, for a maximum daily dose equivalent to 100 mg of morphine, or for longer than 90 days of continuous use. Any other use of a drug would be considered “off-label.”

The PROP labeling changes would also promote awareness of the lack of scientific evidence to support the long-term use of opioids for managing pain.  Doctors and their patients should be aware of the risks of chronic opioid therapy as well as the benefits.  After all, these are very dangerous narcotics that are chemically almost identical to heroin.

What would the PROP labeling changes not do?

The PROP labeling changes would NOT restrict the ability of a prescriber to prescribe a drug for off-label uses.  Off-label prescribing is actually a legal and common practice in the United States.  Thus, if a pain patient is currently on a prescription for an opioid for long-term use or a dose equivalent of greater than 100 mg of morphine, the PROP labeling changes would not in any way restrict a doctor from continuing with chronic opioid therapy for that patient.  If a doctor wishes to initiate opioid therapy for a new patient, that would also not be restricted by the PROP proposal.

Much of the misunderstanding of the PROP proposal stems from a misperception that the restrictions in the proposal are directed at prescribers, whereas they are actually directed at the drug companies.

What scientific evidence is there to support the proposed labeling changes?

The proposed labeling changes are based on the limits of the available data from clinical trials of opioid use in treating chronic pain.  For example, a maximum duration of 90 days of continuous use is based on an average trial duration of 12 weeks.  Effectiveness, functional improvement, and safety for a longer duration have not been adequately studied.  Similarly, a dosage of 100 mg morphine equivalent is based on the much lower doses that are typically used in clinical trials.  Recent observational studies indicate that doses above the 100 mg morphine equivalent level result in a marked increase in overdose risk.

How will the PROP labeling changes affect prescribing of opioids for CNCP?

 The PROP labeling proposal comes at a time when there is a great deal of interest in better educating prescribers about the use of opioids in treating pain.  The collective result of these initiatives should lead to much greater caution in prescribing for moderate pain indications, something that the vast majority of medical experts agree would be a good thing.

The PROP proposal will not place any restrictions on the ability of doctors to prescribe opioids for their patients.  Patients on chronic opioid therapy who suffer from intractable chronic pain will not be “cut off” from opioid treatment.

We recognize that opioid medications will continue to be a necessary element in the treatment of chronic pain.  But even the medical professionals opposed to the PROP proposal acknowledge that they have “serious concerns about the safety of chronic opioid use.”

The PROP labeling changes, combined with prescriber education, will provide much needed balance in our opioid marketing and prescribing policies, which are seriously flawed in promoting the use of opioids for all types and degrees of pain.

You can submit a comment to the PROP petition on the FDA’s website.


Ballantyne JC, Shin NS. Efficacy of opioids for chronic pain: a review of the evidence. Clin J Pain 2008; 24:469-78.

Boscarino JA, Rukstalis MR, Hoffman SN, Han JJ, Erlich PM, Ross S, Gerhard GS, Stewart WF.  Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria.  Journal of Addictive Diseases 2011; 30: 185-194.

Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline. The Journal of Pain, Vol 10 No 2 (February) 2009: pp. 147-159

Dhalla IA, Mamdani MM, Sivilotti MLA, Kopp A, Qureshi O, Juurlink DN.  Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone.  CMAJ 2009; 181(12): 891-896.

Centers for Disease Control.  Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. MMWR 2011; 60: 1-6

Centers for Disease Control.  Policy impact: prescription painkiller overdoses.  2012.

Food and Drug Administration.  FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.  July 1, 2012.

Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain 2004;112:372-80.

Martell BA, O’Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med 2007; 146:116-27.

Papaleontiou M, Henderson CR, Turner BJ, Moore AA, Olkhovskaya Y, Amanfo L, Reid MC. Outcomes associated with opioid use in the treatment of chronic non-cancer pain in older adults: A systematic review and meta-analysis. JAGS 2010; 58:1353-1369.

The views, opinions and positions expressed in this column are the author’s alone. They do not inherently or expressly reflect the views, opinions and/or positions of American News Report, Microcast Media Group or any of its employees, directors, owners, contractors or affiliate organizations. American News Report makes no representations as to the accuracy, completeness, currentness, suitability, or validity of any information in this column, and is not responsible or liable for any errors, omissions, or delays (intentional or not) in this information; or any losses, injuries, and or damages arising from its display, publication, dissemination, interpretation or use.

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Either you don’t understand what you are talking about or you’re spouting bull. As a sufferer of fibromyalgia, I have no structural damage, so any pain meds would be off label for me. Then the DEA will step in and grab the doc because he’s prescribing narcotics off label. Then our insurance companies will refuse to pay for off lael use. We suffer enough. I’m sorry for your loss, but causing harm to us would not have helped your daughter It should be up to us if we risk a problem so that we have pain relief. How would you like living in pain 24/7 for most of your life? Its not fun. If we are any more restricted, the suicide rate will increase dramatically and the sale of illegal drugs will skyrocket. All this government interference is creating a whole new customer base for illegal drugs. Then our lives will really be in danger because we don’t know what we’re getting. Believe me we don’t sell our meds, its too hard to get them and too needed.

Seems I made a mistake thinking Andrew Kolodny wrote this when it was Pete Jackson.
My mistake but still Pete your claiming doctors can still write opioids medications as off label use of the medications.
So your taking away the write for Pain Specialist to write pain medications as to the way they know best. What gives you the write to ruin the lives of Pain Specialist and the patients they treat.
This off label use is ridiculous and you know it ,you know insurance companies will refuse to pay for off label use of opioids for chronic pain. Its hard enough to get anything filled because you all have frightened pharmacist to the point to where they will not fill anything even with a script in hand.

It also seems the better part of the PROP signers are someone who lost a child to opioid medications. Everyone of you are bitter because you didn’t keep a closer eye on your loved ones that had a accidental overdose to pain medications that give all that suffer from chronic pain the relief they need to live a somewhat normal life.
So you take out your bitterness on all pharmaceutical companies that manufacture time released pain medications.
One must be titrated slowly to a level of relief, if someone overdoses it was because they did not follow the doctors orders.

I’m sorry for all parents that lost children to overdose deaths. But don’t make all that suffer even worse because we want live a somewhat normal life without being paralyzed by chronic pain ever day.

we must stop this pro am sorry that his son die but the fact of the matter is these people are not little kids they knew what their were doing not fallowing doctors orders ,the press like orlando sentinel & the la times sems to have bug up their butts they make it look like everybody is doing prescription drugs an thats not the case,the news should get their facts right,now in these days were things is blown out of proportion the lies has become truth & the thruth lies.nobody should have to suffer becouse they want to be political correct.we are not criminals even the elderly are suffering that consequences & action of the DEA,every time somebody dies of something they want to blame it on somebody else that has nothing to do with it.iam scared of the tactics that my goverment are using against their citizens.the only waty to stop this is get organize in every state & to ask for donation for our couse & make the public aware of whats happening here in america,the DEA HAS NO BUISNESS & LABELING US AS DRUG ADDICTS THEY ARE HURTING US & OUR FAMILIES.WE CAN NO LONGER RELIED IN THE PRESS THEY ARE NOTHING BUT CARPET BAGGERS,THEY DON’T INVESTIGATED ANYTHING ANYMORE THEY GO TO THE INTERNET LIKE US,NOBODY KNOW WHAT WE GO THRU EVERY DAY WITH PAIN & SPECIALLY CHRONIC PAIN,WE HAVE TO BE STRONG TO SURVIVE THIS ATTACK ON US CITIZEN,WE ARE NOT CRIMINALS WE DECENT FOLKS FROM ALL WALKS OF LIFE JUST TRYING TO SURVIVE THIS CRAZY WORLD THAT WE LIVE IN.

This Citizens Petition made up by Dr. Kolodny or PROP is one sided, you cant just stop treating chronic pain patients.
Dr. Kolodny I’m very sorry to hear of your daughters untimely death. But don’t let this be the reason why your after all Pharmaceutical companies and the the opioids they manufacture.

Before I found pain relief for the degenerative disc disease in my cervical spine chronic pain had me paralyzed to where I couldn’t move anymore.
Every move and everything I tried to do was like a painful shock to my body,almost like a electrical shock. I was scared to go anywhere,scared to go to the grocery store in fear of not being able to finish. I tried all alternative doctors wanted me to from epidural injections to acupuncture to Botox injections and nothing helped my chronic pain. Sometimes it was severe,other times it was moderate but mostly severe.
In 1999 I finally found pain relief from carefully titrating up to a safe dose of OxyContin.
Dr. Joel Hochman slowly titrated me up to a level of relief and I could not believe the pain relief I achieved. Unfortunately we lost Dr. Hochman to kidney cancer in September of 2010.

This petition your wanting to pass will eventually put all pain patients back in chronic pain again ,you say this is not your intention but ultimately this is what will happen. Then pain patients will go to the streets to find pain relief if they don’t commit suicide first then we will have a problem with heroin use again.
With that comes diseases of all kinds, dirty needles causing hepatitis ,HIV and AIDS. Not to mention crime so people can afford their illegal drugs for the chronic pain they once had under control with clean pharmaceuticals.
You think your doing something good but eventually it will just cause another problem. Has the WAR on Drugs worked ,how is this any different.
Your just going about it a different way.

Know that this petition will do more harm than good, and when all is said and done we will all thank you for putting good people back on the streets to find pain relief. The 100 mg morphine equivalent cap is totally arbitrary as is the 90-day suggested max. The science does NOT support label changes. Hurting chronic non-cancer pain patients can never bring your wonderful, beloved Emily back. I hope you can find peace in your heart and you will stop lashing out at innocent people who never asked to suffer with painful conditions.
It would be best you withdraw your petition before it causes more harm than good.


Mark S. Barletta


You seem surprised to hear people’s comments thinking that this change would cut them off from the narcotics they are taking. As a patient is is hard enough now for our doctors to write prescriptions for our opioids. Like others have mentioned, they are nervous because of all the limitations being put on them already. You actually think this isn’t going to make it more difficult on us to get these prescriptions when our doctors are already feeling the heat? Do you think they want to be the doc that writes a lot of “off label” prescriptions? What about our insurance companies. They are always denying claims left and right. A drug written “off label” is hard to get approved.

I can’t imagine the pain of losing a child. With that being said, the people abusing the medication and/or getting it illegally are still going to do the same things. You are wanting to put more rules on the medications and the people following the rules are not the problem. Why should we suffer because someone else can not take a medication properly.

I imagine you have no idea how it feels to wake up every day in pain and go to bed every day in pain. Every second of every day is pain. I suffer from arthritis and fibromyalgia. In 2 years I have had 6 major surgeries related to the arthritis damaging my joints and spine. It’s not going to get better. I ache every where all the time, it brings me to tears some of the time. I can not ride in a car longer than an hour without major pain and that’s with my medication. I am only 52. I, like everyone dealing with chronic pain, do not expect to be pain free. I just want to have a little relief so I can bear to live life a little. It would be nothing short of cruel to have us suffer the way we would without our medication. Would you like to even guess what would happen to suicide rates of those with chronic pain? Just because you can’t see pain doesn’t mean it isn’t there.


Since June 14, 2011, my life has been turned upside down because if a disease caused RSD. RSD pain is officially recognized as worse than cancer pain. I hate that I have to take opiod pain meds but without them, I assure you, I would not be here today. You worry about overdose? How about suicides by people who are in so much pain they can’t live a normal life. I can’t stand all you self- righteous jerks who take in a cause because if the tragic loss of a love one. Stay out of my life. I follow my Doctor’s orders and take my meds as prescribed. I already have trouble getting insurance to cover all my meds. All your proposed labeling is going to so is fever insurance more reasons to not cover our meds. If you are so worried about opiod drug abuse, then why don’t you work toward legalizing medical marijuana nationally, or is that a no-no too in your self- righteous mind! You wonder why I’m so angry? Look up RSD. Maybe you’ll understand. I’m sorry for your loss, but people are responsible for their own actions. You takes meds incorrectly, you suffer the consequences. If my pain meds do me harm over time, that’s my business, not your!

dan robinette

this info in this post is sad but we can not blame that responsible opioid use is the problem here the real problem for the deaths related to opioid abuse and misuse is that the people that are not in pain and the people that do not follow the proper dosage prescribed by ones doctor is the real reason there are any opioid deaths in today’s society so blaming doctors for over prescribing opioid’s is not the way to solve this issue people the only way to solve this is to better aware are children and grandchildren that these can be dangerous medications if taking by someone that it’s not prescribed to cause all prop’s petition to the FDA is going to do is hurt the 100’s of million americans living and suffering from moderate to severe chronic pain. Go to this link and you can fight back to stop prop’s petition and have your voice heard by goverment and non goverment agency’s here is the link log on and sign it today and post your opinion’s online , thanks for your voice , Dan Robinette, Columbus,Ohio

As somebody with chronic pain who has to consume opioids on a daily basis I can fully understand why there is a great deal of fear amongst people like myself about the PROP Petition and I almost signed the counter petition as a knee jerk reaction. However, I recently carried out a great deal of research into the tragedies caused by the abuse of prescription medications that have occurred because of commercial corruption and lack of practitioner re-education. Many of us who have to use these drugs, or suffer a lifetime of pain filled misery, are responsible people who do not experience a high because the drug is otherwise employed. PROP needs to reach out to groups like my own to explain their proposals clearly in order to counteract the campaign of misinformation that has generated counter petitions. I will be posting information on my FB page in order that those in my group can make an informed choice about where they stand. Personally I will not be signing the petition I mentioned in my opening sentence, too many young people have perished because nobody ever questioned the propoganda put forward to promote these dangerous compounds.


I have been suffering from Systemic Sclerosis for many years, along with several other conditions. I will never get better, this is a rare incurable disease. It has affected many of my organs, my joints, a side of my face has begun to cave in, part of my ear has disintegrated, my entire digestive system is not functioning properly, cartilage, tissue, vascular and nerves, have already been affected. Any and every part of my body can be affected at any time. Each patient is stricken differently from this disease. I was once a vital part of society, now I can barely get to my appointments. People like myself, have already had to suffer in pain. I already have several medications that I have to take, but medicare will not cover. My medical bills are astonomical. I am in constant pain. I understand that when we loose a child, we look for someone/something to blame. I have been through what you are going through. It is heart wrenching, to bury your child. Part of you dies with them. It is sonething that never leaves you and only another parent that has been through it can even begin to grasp the wrath of it. It’s not natural, my thoughts and prayers are with you for that. There is no recovery from this type of loss. There may come a point in the future, we realize that our child was not a total innocent in the outcome, in some cases. They were not forced to swallow that pill, drive that fast, or drink that drink or even drive after that drink. Whatever it be they made a stupid decission somewhere along the line, in all of this. It is hard for us to accept, but you say she was a bright young woman. All medication already has a warning that it should not be given to or taken by anyone other than the patient that it is prescribed for. I don’t understand why she took a medication that was not prescribed for her, or am I mistaken and she was under doctor care to have this medication. People can die from the least of medications, due to an allergic reaction or some other stange and unforseen circumstance. That doesn’t mean that the medication is bad for all. You do not realize the ramifications and injustices that this is causing to those of us struggling to have some form of life and independence as we suffer in silence and alone. We need our pain medication to survive each day. We are not the enemy and neither is the medication, that helps us to make it through each day that we have left on earth. Supply has already been a problem for us, and I know I am not the only one. I have had several occasions, in which my legitimate pharmacy did not have the medication to refill my legitimate prescription, since all of this began. My legitimate doctor is in fear now in… Read more »

Dr Know

So, you think it is appropriate to list as references articles by fellow members of PROP? I would say that is a major conflict of interest. Also, you fail to mention that most of the overdoses and deaths occur among drug abusers who have obtained a script fraudulently or illegally purchased them from a drug dealer. The incidence of overdose and death among legitimate patients is low.

The opponents of PROP are not making uninformed statements. We reject those guidelines because they are a modern day Trojan horse. We understand that changing the label does not effect how doctors prescribe a medicine. Changing a label does effect the policies of health insurance companies and programs like Medicare. Insurance companies do not always cover medicines that are prescribed off label. I suspect they would be even less likely to approve the use of opioids off label , since some of them are very expensive.

We know you have read the rebuttal and counter petition by PROMT and AAPM. The issues with the petition created by PROP have been addressed. We are still waiting for a response from PROP other than “you just don’t understand or get it.” Which is basically what that Medscape article said.

I am very familiar with the evidence for the use , safety and efficacy of opioids. I still stand by my comments.

Chronic pain patients are already suffering from the intense and heavy regulation of prescription opioids. I don’t understand why the members of PROP are so surprised that almost all chronic pain patients and an innumerable amount of doctors oppose the petition.

Also, if the petition by PROP would not change anything, then why submit it at all? Your comment is essentially saying that nothing will change. So, why spend all this time and energy fighting for something that will not change anything?

To all of the commentors who asserted that the PROP proposal would cut them off from their supply of opioid drugs, I have pasted in the following statements from my article. There remain many incorrect statements about the PROP proposal. This appears based on a misunderstanding of what labeling means.

“The PROP labeling changes would NOT restrict the ability of a prescriber to prescribe a drug for off-label uses. Off-label prescribing is actually a legal and common practice in the United States. Thus, if a pain patient is currently on a prescription for an opioid for long-term use or a dose equivalent of greater than 100 mg of morphine, the PROP labeling changes would not in any way restrict a doctor from continuing with chronic opioid therapy for that patient.”

“The PROP proposal will not place any restrictions on the ability of doctors to prescribe opioids for their patients. Patients on chronic opioid therapy who suffer from intractable chronic pain will not be “cut off” from opioid treatment.”

To the person who claims that opioids have been proven safe and effective for long-term use in treating chronic noncancer pain, you need to review the scientific literature on the subject, which I have listed as references. I wish it wasn’t so, but a sad reality is that when opioids are used long-term, adverse risks are undertaken. Drug companies have been reluctant to acknowledge this because it would impact sales. All we’re saying is that people need to be aware. Keeping our heads in the sand helps noone.

Claire Barnet Vosburgh

My fiance has been in severe pain since he FELL in a hospital in 2000. (not to mention they covered up his fall) He hurts with every breathe he takes. He cries every morning when he wakes up and realizes it wasn’t all a nightmare. There is not enough pain relief medicine to make him comfortable. He has lived in hell for 12 years now. He begs God to please take his life, he cannot stand another minute. he is scared to kill himself, because he believes he would go to hell. He talks about throwing himself down the stairs so he will be totally paralized. This man was the HAPPIEST, FUNNIEST, most hard working, ACTIVE man I ever met. Now? He is in bed 24 hours a day. He was getting better though. We had plans to start working out at a pool down the street. I thought that these low impact exersizes could help build his muscles, and give him some stamina. But then? In may, His Dr told him she had NO CHOICE but to cut his methadone in HALF, and reduce his oxycodone by 60 a month as well. she didnt want to do it, but told us all of a sudden that they would not fill any more than 180 tablets of anything. Funny. WHO is his Dr? The DEA? do they know what he goes through? do they know his injuries? do they know how much he suffers? do they know that he has had enough? NO. It is none of thier business. so now, back to bed 24/7. Sick. Jerking all around from the spinal cord and nerve damage he has from the surgery that butchered him. Not to mention his cocyx (butt bone) broke and grew back backwards. This man cannot stand to be in his own skin. And you think a pain relief pill will make a difference???!!!!!! WHO ARE YOU PEOPLE TO DENY HIM COMFORT? SHOULD HE BEG MORE? As it is now you people will be happy to know that we drive every drop of gas (since being disabled he is unable to make the wonderful living he made before and we are beyond poor) driving from pharmacy to pharmacy to pharmacy trying to fill the prescriptions, because the DEA has the pharmacists scared to death here in florida to fill anything. Nice to know the sickest people among us, the ones that SHOULD be cared for, have to BEG for pain relief. It breaks my heart to see my loved one like this. to hear him cry and there is NOTHING I CAN DO. I’m so sorry someone’s daughter lost her life from one oxycontin. for one thing they have been re formulated and dont even work as far as pain relief anymore. But that has NOTHING to do with my loved one, and he should not have to suffer any more becuase of it. He has suffered enough for about TEN THOUSAND people, thank You very much.… Read more »


The facts of the matter are opiate drugs have been proven safe and effective. They are the only for patients who suffer from intractable pain. Some patients may be helped by other non-narcotic medications like anticonvulsants or antidepressants , but that is it. There is little evidence for therapies like acupuncture and there is absolutely no evidence for herbs or holistic medicine or anything of that nature. Intractable pain patients use opiates because they are effective. The history of the opium poppy plant clearly demonstrates this. Despite what the naysayers say opioid medicines work and there are plenty of studies to show that. Pain patients tend to agree uniformly that opiate medicines work and are fine. It is the healthy people who have no pain that fear them.


All Patients are entitled to have quality medical care which is evidence based. This is not about one group of patients vs another group. Patients should not be divided by systemic failings of government nor a medical system which has given way to iatrogenic suffering. All patients should stand united for better patient care for all; informed care not sales.

Millie Andreasen

Mr. Jackson, first of all, I am very sorry about your loss, but you need to stop and think your position. I am a 52 year old female in intractable pain since an accident in 2007, after 5 lumbar surgeries and one cervical, I was left in the most unreal pain that I’ve ever felt in my life, and I will be one of those, that will get affected negatively if the FDA changes the labeling in narcotic medications.

In the 9 + years that I’ve been taking opiods, I have NEVER taken more than prescribe, I have NEVER gone Doctor shopping, and I’ve always use the same pharmacy to fill ALL of my prescriptions. I lost my job, my home and my life due to this pain, and now I am in danger of loosing my medications because of this re-labeling that you and PROPS are proposing. Can you stop and think for a second, of the millions of people that suffer from chronic and intractable pain? Can you stop and think, of what is going to happen to those of us that depend on these medications to live? Can you stop and think, that is not our fault that your daughter died of an overdose, she made a decision to take this pill, and because of that decision, you now want to; “throw the baby out with the bath water”, in order to do something about your pain. Can you stop and think that many of us, will probably choose death if we don’t have our medications, can you stop and think………..

As anon stated above, I am also sorry for the loss of your loved one! I pray that some day you will find peace. I also Pray that a solution to this important matter is found and all people involved will benefit. I am Still opposed to the Citizen Petition filed by Prop. I have had many months to review the statements made by Prop and their supporters. I am becoming increasingly insulted by the language Prop has used. Setting the Benchmark at cancer is very short sided and discriminating. In my conversations with Parties for and against this petition most agree that the term Severe Intractable Pain such as cancer or Arachnoiditis, Rsd , CRPD. etc would have been a better benchmark. Using the excuse that cancer was used as there were studies done is very short sided. I have arachnoiditis and one of the pioneers of arachnoiditis research has tracked Patients long term most being on long term opioid therapy. The studies did not come close to concluding that Opioid therapy both short or long term was either unsafe or carried the risk of addiction. Dr. Tennent also did many studies on pain and the treatments for pain. He concluded as well that if administered under the skillful eye of a properly trained physician that they are one of the safest treatment options available. While I agree that there is a growing problem with Prescription drug abuse , I find it rather convenient that Prop and their supporters objectively choose to use the data that they have written. To be fully objective the whole gambit of data available needs to be considered. Prop has been very short sided in their effort by using convenient Blinders and ignoring the other data. Lets face it. With the congressional Energy and Commerce Committee headed in part by Mary Bono Mack taking up this issue on the side of Prop, a group of legitimate Pain patients formed and have written a Citizen petition directed to FDA . The true victims of this war on addiction will be the People who suffer with severe intractable pain that is not well treated and Opioid therapy remains one of the few effective modes of release from their pain. I feel that with the power of Social media and other internet media that for the first time in history the voice of millions of pain patients will be heard! The other problem as we see it is the gross abuse of our civil rights. When you have lobby money being used to get a petition rushed through the FDA process, the rights of american citizens and those suffering from severe intractable pain are being steeped on and ignored. I ask each and every reader of this blog to truly think about the endgame, and ask yourself if you could live for 20 + years in extreme pain and not ask for relief! You can view or sign the petition against prop here


I too, am sorry for your tremendous loss. Unfortunately, though, this agenda by PROP WILL have devastating effects on the pain community. Insurance companies, as others have stated, WILL NOT pay for ” off label” prescribing, and many doctors do not want to draw attention to themselves for ” off label ” prescribing. Also, absence of evidence does NOT equal evidence of absence! Do you know how hard it would be to do a longterm study on opioids? What person, who suffers from serious, daily, pain, would subject themselves to being in a 20 year study & risk being in the group that receives the PLACEBO???? The idea is ridiculous & cruel! The closest we have, are patients like me, who have been on opioids for over ten years, with NO negative side effects. As anon stated above, the 90 day / 100 mg. maximum is arbitrary & not rooted in scientific evidence. To assume that chronic pain patients have somehow been “duped” by unscrupulous doctors & evil pharm companies is also incorrect. Most of us, have tried every other alternative available to us, with no meaningful success. We understand the risks associated with opioid use, and take them anyway. We do this, not because we’re pathetic addicts (as many like to assume), but because if we don’t take them, we suffer from immeasurable, disabling, daily pain! We can decide for ourselves whether or not they decrease pain & they DO! why on earth should I have to suffer because of a genetic condition that causes disabling pain? My life is hard enough without getting SOME (about 50%) measure of relief! Opioids are also not the ONLY tools we use to combat pain. They just happen to be the most effective tools we have. I would have committed suicide years ago, if not for finally resorting to longterm opioid therapy. I am lucky to have a competent doctor, who has educated me about the risks and benefits of opioid therapy. Many people can’t find a doctor these days, to even entertain the thought of giving them opioids, because of the media hysteria, misinformation about the dangers, and ovzealous regulations. There are risks associated with most medications. If opioids are taken with alcohol, or other contraindicated substances, or are give to non-opioid tolerant people…. They can cause death. I agree with national databases to prevent doctor shopping, one prescriber, one pharmacy, better & more treament facilities for the disease of addiction, better patient education, etc…. BUT…. To further burden pain patients, who already have to jump through hoops to have their pain treated, is CRUEL. if ANY PROP member or supporter, spend one day in my shoes without the use of opioids…. There simply would be NO discussion. I suffer from intractable pain from a genetic connective tissue disorder. The pain i have lived with my entire life is simply UNBEARABLE without treament with opioids. There are many others just like me. So, please…. Don’t use your broken heart, as an… Read more »


Pete, first let me say that I am sincerely sorry that you lost your lovely daughter to oxycodone. I do understand how such an unspeakable loss can cloud a caring parent’s vision and make them biased against opioids. The sources you cite in your article are largely written by PROP people (Ballantyne et al) so of course they support the PROP position. Labeling changes WILL have a devastating effect on pain patients. While not prohibiting opioid prescribing for non-cancer pain, forcing doctors to prescribe “off-label” will discourage many of them from treating chronic non-cancer pain patients (PROP’s goal!) and insurance companies may decline to pay for off-label uses. You know this! The 100 mg morphine equivalent cap is totally arbitrary as is the 90-day suggested max. The science does NOT support label changes. Hurting chronic non-cancer pain patients can never bring your wonderful, beloved Emily back. I hope you can find peace in your heart and you will stop lashing out at innocent people who never asked to suffer with painful conditions. I wish you well.