URGENT: FDA May Remove or Limit Access to Opioid Pain Medications

Below is my letter... not sure if I did it right BUT they will at least read what I wrote and understand they can not take these drugs away.

thanks

I am a chronic pain paitent and have been since 2000.
I take oxycodone, my body can not handle any other medication, I am allergic to
so many. I take precautions with my medication as I am sure alot of adults do, I
have a locking safe I use, I never open it when anyone is around.
Without my medication I am so severly limited in my activities, I have missed out
on so much of my kids lives so far, now they are 16 and 17 and I struggle to keep
up, BUT I do keep up. Without my pills I will be in the house ALL THE TIME,
weather changes keep me in the house enough, I don't take NEARLY as high a
dose as I could, but it is high enough to let me appear 1/2 way normal.
Please do not ban these medications, I know I am not the only person who suffers
on a daily basis and I know there are people worse off than me.
Please listen to us, you are the only ones who can save us from suffering daily.
thanks so much
Jean Omet

I understand the FDA is evaluating opioid pain medicines using Risk Evaluation
and Mitigation Strategies, to try to deal with abuse of these medications.  I
understand the concern which is felt concerning the rise in abuse, misuse and
accidental overdose of these powerful medications; the FDA has always responded
to crises like this one, in ways which have on the whole been helpful.

I am a patient with a number of chronic medical conditions which are only
mitigated by the use of pain medications of these types.  I suffered for many
years, trying to find ways to cope with my pain, but I could find nothing else
but pain medications which would allow me to function from day to day.  I have a
flawless record of the correct use of these medications, and I keep them locked
in a safe to prevent abuse or accidental use of them.  I take every precaution
to keep them away from anyone else, other than myself and my wife, who helps me
with my medications daily.

If new laws are passed which would make these medications too difficult for me
to obtain, or which cause them to cost much more than they do now, I would be
forced to spend the rest of my life bedridden and miserable. Before I found the
pain clinic I presently visit and before the doctors there, who specialize in
pain control (most are anesthesiologists) were able to put me on a conservative
regimen of pain medications for the multitude of health problems I suffer with,
my life was a constant struggle to find a reason to live, because the pain was
so overwhelming I was not able to do anything but suffer with it!  I was unable
to contribute to my family, my community, or anything else, and I became a
burden to my family, to the government welfare programs, and others.

Since attending the pain clinic and beginning the pain control regimen which
includes pain medications such as are being examined by the FDA, my life has
changed drastically.  I am able to do many things which were out of the question
before.  I am well on the way to returning to work, as an Electrical Engineer,
and to being an active member of my community, church and family.  If I can
continue on the pain medications for as long as I need them, I am certain I will
continue to improve and make a contribution to the U.S.A. in my work and my
activities.

For these reasons, I ask that the FDA be very sensitive to any restrictions on
the prescribing of pain medications to chronically ill patients who obtain those
medications from professional medical doctors, as well as to the obtaining of
those prescribed medications from legitimate, licensed pharmacies.  I know that
some changes may be needed to curb the current problems with opioid medications,
and I will do my best to cooperate with those changes.  I hope that the FDA will
find ways to do this which will not prevent patients with legitimate chronic
pain conditions from obtaining the medications they so desperately need to live
a decent life.

If I may be of any assistance in this study, please do not hesitate to contact me.

Oxycontin, and then Fentanyl patches made it possible for me to return to work

for a few years. Without those medications, not used at the same time,

during the same time period, that could not have happened. I have chronic pain

syndrome with complications of Osteoarthritis accompanied by bone spurs growing in my joints and in my spine, where the main source of my pain is. I am very careful with dosage, respect the medications, never abuse them, and could not lead any sort of a

normal life without them. The fall-off rate is extremely quick with the non-extended

release versions, and while still useful, they open up the possibilities for what I

call "pain attacks" whereby once the pain, if unencumbered by the presence

of the correct dosage administered exactly on time, 4 times day including in

the middle of the night, these pain attacks can be totally crippling and last

for up to three days even afterresumption of the medication.

Blood levels of the medication must not drop below a certain point at any time. In my

body the time it takes my body to re-acclimate and reestablish the correct levels in my blood can cover 12 to 72 hours. I do not know why. Years of use are my evidence. These medications truly are of life or death importance. If I lose access to Fentanyl, I would probably move to a wheelchair for movement, and since my shoulders and arms are severely affected by pain, all useful activity by me would likely stop. I can only imagine how bad the nightmare that already is my life-- even with these medications-- would become without them. Surely, I might lose entirely any will to live on from that point, a mind that works trapped in a body which doesn't, surely a "Hell-on-Earth" for myself and those like me. Please do not let the misuses and incorrect activities of a few sentence me, an honest, law-abiding patient, to that kind of existence. 

Thank you for your consideration. 

Dean D. Allen

Hello to the fellow members of the Chronic Pain Connection,

I am an idividual that uses the opiod long-lasting treatment. I have RSD/CRPS, three buldging disks in my lower spine, and osteoarthritis in the joints of my spine, OA in my knees and the RSD (type caustalgia) is in both my lower legs and feet. On top of the drug therapy I have a Spinal Cord Stimulater (SCS) for the RSD. I have just sent my letter to the FDA through the American Pain Foundation. My pain center does quarterly random drug screens not only to look for illegal drigs but to make sure what I have been perscribed is in my system. I am only allowed to use one pharmacy for refills and I have to go to the pain center once a month for new perscriptions as there are no refils on the opiods. I would only hope that other physicians are as thourough as the one I go to. Whith all of this they keep me on a low dose and I live on a pain scale of "7" which is still painful but at least I can function.

The other thing the FDA needs to keep in mind is that a person that has an addiction to one thing means that they have to be careful as they can switch what they are addicted to. It is not the drug it is the "addiction" which is why there are addictions to gambleing, sex, drugs, and even to exercise and etc.

I am sorry for those who overdose on steet meds (perscriptions) or for irrisponsible or untrained doctors and this should be looked into. Since I have a disease of chronic pain and I am on so many other medications, I always go home and check out the reactions of a new medication against all my others so I know what may happen with taking the new medication. I personally have a pharmasist that I see which then what he percribes must be checked by one of the doctors that are specialized in Pain Care.

I think the FDA needs to look into the physicians that are not specialized in proper pain control but are perscribing this could lead to death of a patient, and this is unacceptable.

I understand that there are many people that use to many medications,but I am a patient that has many chronic pain threwout my body.I think it should be monitered,however some of us would not be able to get up and make it threw the day, I do not take pain medication but i know that I get my doctor to okay everything ,I think where the abuse comes from is people that go from one hospital to the next.Please dont allow this to happen,if you hsve ever had pain,then you have been where o many people are.People with cancer,heart disease,lung disease,m.s,amny things should be taken in good looks before we have more of our rights taken, even under our doctors care.I speak for many with chronic pain,but have to try to live as normaal of a life that we can.

I understand that the availability of the opioid pain medications is being assessed for safety, with the possibility of limiting their availability. As a chronic pain patient who is disabled by chronic pain, I request that the improvement in both the quality of life, and the independence gained for chronic pain sufferers from the use of these medications be considered strongly. As a chronic pain patient, I can assume you it is already difficult to have a disability that is invisible. It is already difficult to obtain pain medications from physicians due to existing restrictions and stigmas. These medications serve an essential function of allowing chronic pain to be dealt with as well as adding independence and ability to enjoy some semblance of normal life when possible. No other class of medication can currently take the place of the opioids to relieve chronic pain. Many patients will be unable to comply with obtaining their pain medication from a licensed center as proposed, due to their chronic pain, or deal with finding a particular doctor and/or pharmacy who is licensed to dispense such medications. Any barrier is difficult to surmount when one suffers from chronic, disabling pain. Without reasonable access to pain medication, please consider the toll on chronic pain patients - depression, isolation, helplessness. They may become a further toll on their family, or so depressed they can no longer seek care, or be restricted by their pain to seek it in a timely manner. I understand the considerations of this proposal are only to limit access to these medications, not remove such access from patients. But the practical effect will be to make it more difficult to obtain appropriate medication, and chronic pain sufferers will suffer greatly due to this. Any obstacle is magnified when you suffer chronic pain, especially, as I mentioned above, as this condition is still not easily accepted nor recognized by our society or even by some physicians. Please do not restrict patient access to proper pain medication by any of the proposals in REMS, or make it more difficult to obtain by patients who need it. I assure you it is already difficult to obtain for those who need it. Thank you,

good morning senator,

my name is mike graham, i'm a 46 year ol disabled man. i have suffered from a degenerative condition in my spine.  i currently have a spinal cord stimulator and a morphine pump installed inside my body.  back during my first spinal fusion, i was prescribed very large doses of  medication to battle some of the pain i was in.  the oral opiates almost killed me, i was bedridden and had lost over seventy pounds.  if not for the recommendation of a hospice nurse, i wouldn't be here writing letters on this issue, i would have died.  i don't want to take up too much of your time, so i'll leave that as the reader's digest version. 

there are too many people that are suffering needlessly.  is marijuana the answer to everything, obviously no, but it works for me, and many others, so why shouldn't a doctor have the ability to eleviate pain and suffering in some if they can? it doesn't make sense.  i was taking more prescribed medications for the side effects i was having from the opiates i was taking.

please support s.b.1381 for all of the patients in illinois that can benefit from it!!

thank you,

mike g
manteno, illinois

I had major back surgery 3 months ago and have been taking Oxycodone since I came home from the hospital.  Without it the pain would have been unbareable, this type of medication is necessary to get you through the day and to help you sleep at night.  The actual pain is not understood unless you have had to suffer through it, I have been taking it 3 months are have no sign of addiction.  Medication like this are necessary please don't take them away.

I am responding to the proposed FDA changes and additional controls to be put into place with regard to how opioid pain medications are prescribed to patients who require these types of medications to function, feel a little more comfortable and regain a reasonable quality of life.

As an individual with inoperarable degeneratie disc disease, radiculopathy, joint pain and other documented sources of chronic pain, I do depend on a very modest, daily amount of oxycodone for relief and function.  It has already been very hard to find doctors who are willing to get involved with pain management and existing regulations.  I think it is unfair to put these doctors under more scrutiny and impose more demands because this may result in more of these (very limited) doctors to just stop prescribing all together.  It is also unfair to treat patients who just happen to have chronic pain (which responds best to the the oldest and simplest types of pain medications) to be treated like "criminals". 

Just because there are some derelicts who will misuse or steal these types of medications but ALSO others - as there is misuse of anything from diet pills, ADD medications to antidepressants - are you planning on "cracking down" on all these innocent patients and their doctors as well?

Furthermore, there are other genuinely illegal and far more serious/ potent drugs (crack/ heroin, cocaine) which cause addiction and generate a lot of crime -- from theft, to shootings and prostitution in neighborhoods --- why aren't the efforts and focus going on these far more serious issues, in view of the corruption and crime those type of drugs cause than to isolate and start picking at ordinary people - many barely able to live their homes, due to severe pain.   

What is most offensive are these (3) suggestions:

   - Dispensing the drug to patients only in specific health care settings.

   - Monitoring each patient using the drug.

   - Requiring patients using the drug to enroll in a special registry. 

It is VERY WRONG for the FDA to create these sorts of measures / monitoring tactics which clearling makes having chronic pain a CRIME!

PLEASE DO NOT DO THIS TO INNOCENT, SUFFERING INDIVIDUALS AND THE FEW DOCTORS WHO ARE STILL WILLING TO UNDERGO EXISTING SCRUTINY AND CONTROLS.

Thank you for letting us all know about this crucial information.I seems as though the federal gov. wants to regulate everything we do in this country! This is just one more way to put a collar on us,the true chronic pain patients! What is coming next. If a registry is formed,this is just one more way to control our pitiful lives!!! Nicoletti...

I was glad that you posted the website to be able to at least voice an opinion!! Thank you for the opportunity. Stace

Please consider all the people who suffer on a daily basis and the pain medication makes their life a little easier. I for one have suffered for years with pain, without pain medication I would not be able to get out of bed some mornings. I suffer from arthritis in both of my ankles, my knees, one hip , my spine and elbows, my fingers are starting to be crippled with it. I also have a vascular disease and cannot take the arthritis medications. So consider the ones suffering and find a way to control this problem without being so critical of the people who take them. Maybe we should find a better way to curb the drugs coming into the country and that alone would take care of alot of the problem of drugs on the streets and to our children.

This is what I submitted, but after submitting, I got a message that I wasn't guaranteed my thoughts would get to the FDA. I chose the catagory of "Consumer Group".

_____This action to remove these proven pain relievers that have been in use for
thousands of years would be the most rediculouse action the government should
be involved in taking action to remove their legal availability for people in chronic
and horrific pain.
_____I am a person with a chronic and dehabilitating condition and without these
drugs, I would probably be in a government subsidised nursing home, as I would
not be able to even get out of bed without my meds.
_____ I am also trying to start a small business, which this economy needs, and that
would definately not be possible at any stretch of my abilities to operate my
computer, without my opiate based prescribed medications.
_____Another catastrophic side affect is the fact that these meds will become
available through drug cartels, creating horrific crime rates of unimaginable
consequences giving the power to the drug lords who penitrate our cities, and
suburbs. Many of the overdoes that occur, which are terrible, of course, are
becuase of these illegal drugs such as heroin that is easily available on the
streets, but are unregulated in their strength; which causes a great deal of these
accidental overdoses. I know of a bad batch that came to my suburb last summer
and new of 3 people that where affected by someone overdosing on this street
substance. Two of those kids died, and I do not know a whole lot of people.
_____It is also possible that people who do not have insurance are currently using
the street drugs that come in from other countries for their pain.
    People such as myself who are in chronic pain and use these medications to
relieve symtoms of an inoperative condition would be seriously affected. I,
personnally am a responsible adult, that makes sure that my medications to not
get in the wrong "hands".
_____Those "hands" that would just find something else to abuse such as sniffing
chemicals or whatever they come of with to get a "high". These kind of people will
just be creative in abusing some other substance with a probable higher death
rate and other severe consequences.
_____I repect our laws, but must admit, without my legal medications, I cannot say that I would not seek out my medications on the street.

I also sent a statement but didn't print nor save it.

But I did add my voice to try to make them understand that those of us who find it necessary to take these medications do not take them for some thrill or "high" we do not get that from them.  If we are lucky we get some modicum of pain relief.  We also have enough difficulties getting thru our days as it is ... we do not need to have more difficulty in obtaining the little relief we have come to count on .... Those that will abuse the medications will abuse them regardless .... hasn't history shown that in all areas ?

Do any of us choose to go thru this hell and to have to deal with our family and friends views of our situation and medications?

Good luck to all

I also did not save my letter. I basically told them what my problems were and stated that I would not be able to function without them. I also said that those of us who need the pain medications and take them as prescribed and do not abuse them should not be punished because of the ones that do abuse. I think you all did a great job and I hope that our letters reach understanding members of the FDA and they do not make it hard to impossible for us to get the relief we so desperately need. Thank you!

Jill

Here is another suggestion that might get some attentionon. I was just reading that Congress passed a law today that the FDA can monitor and regulate the way that cigarette manufacturers make and distribute their products. Not a bid deal to non smokers. However this is just one more freedom that the American people in general are losing. The Government is slowly taking more and more control over our lives. I suggest that people go to www.whitehouse.gov and start writing letters to the president. Sure he may not read them personally however if enough of us write to voice our concerns maybe they will listen to us. We are the people and our voices should be heard. We are guaranteed by the constitution that this is our right. The government of the people for the people.

I am going to write and I hope that others will also.

Thank you,

Jill

With respect, I would like to address the proposed issue for opiod drugs.  I have had three back surgeries for a ruptured disc (L4-L5), one including a spinal fusion. I did not have to go on pain medication until after my second surgery when I had major complications.  The S1 nerve root membrane tore during surgery and I leaked spinal fluid.  This had to be patched after causing a lot of nerve damage.  I have muscle atrophy in my right calf and thigh.  I also have considerable numbness and tingling in both legs.  I have horrible pain in either one side of my lower back, hip, and on down to my feet.  Most of the time it is on the right side, but sometimes, for no reason, it transfers to the left.  It feels like a burning knife stabbing in my back and the pain never stops if I do not have my medication.  I have been on all of the various narcotics and because of the abuse, I don't even want to state what I take.  I am very protective of that information and I keep my prescriptions locked up for safe keeping.  I am prescribed a total of two narcotic medications, tramadol (50mg every 6 hours), and topamax (200mg 3 times per day) as my pain regimen.  I have consulted with doctors at the University of Virginia and Cleveland Clinic within the last year to see if anything else can be done for me surgically so that I can reduce my meds or get off of them entirely and the answer is "no".  I am just thanking the good Lord above for the creation of these medications, for without them, I would literally have no life.  I would be laying in bed, in excrutiating pain, unable to do the things that I do.  I am not completely without pain, and there are days that I am in bed, but I can still work and enjoy life.  For those of us that DO NOT abuse these drugs and are cautious, protective, and responsible, please do not punish us.
Thank you!
SoBlest

I tried to save my comment, but wasn't successful...oh well..

I brought up how access to my meds would basically alleviate what quality of life i currently had and probably put me back into the sucicidal stage I was in prior to my doctor's putting me onto my current pain regimen which I've been on for quite a few years now...and I brought up about how difficult it was for pain patients to get adequete pain medication in the first place because physicians are so afraid of losing their licenses due to over prescribing of opiods and how that is so ridiciculous because its a well documented fact that people who are truly in pain and take pain meds and then stop using them when their pain is no longer a factor don't get addicted...I also brought up about how docs and pharmacists need to get better educated about how pain meds work and how NSAIDS really don't work yet physicians rely so heavily on them...what a croc!!!  

Regarding that Registry they are talking about...I asked them if they would make aids patients or cancer or diabetes patients register in order to get their medications...then I also commented it would likely be shot down under the Americans with Disabilities Act if it were enacted because it is discriminatory against us.  My pain is my disability.

And then I asked them not to restrict my access to my pain medications and not to enact the registry and thanked them for listening to my comments.

Hopefully our comments will do some good!  We all need to send in comments.  If you havent done so already folks, please do so.  This is really important to our futures as pain sufferers.  Don't let this go by as something someone else will do because its your own future at stake here as a pain patient.  They are still accepting our responses until June 30.

Barb

I am writting about the risk of losing my medication for pain. I understand the risk of taking pain medicine and also the benefits. If I didn't have my pain medicine I would not be able to do much of anything, but be in bed all the time.

 I had along time before I could get pain medicine for my chronic neck problem and bladder. Life is so hard as it is, without some help with medicines to relief this awful pain. I take my pain medicine as less as I can and use muscle relaxers. My doctor regulates how many or how much pain medicine I can get. I don't let others use my medicine and it is locked up.

  I just hope that the FDA want take away the only lifeline some people have to have a half way normal life. I know others who are in severe pain all the time. I have pain daily, very few no pain days. I hope that the people who really need these medicines continue to get them, because they really need them to survive, alot of sucides come from hurting so bad or thoughts of sucide. I know I was once there myself with no help. Thanks for letting me add my input on this.

I have suffered from rheumatoid arthritis for several years with limited income without prescriptions for pain medications pain would be intolerable no one could understand until they have been there please have compassion on people with chronic pain we just want to be able to enjoy our family and life half way normal please dont destroy us i know there has to be a way to reach this goal and save  our young and monitor  abuse . thank you

I wrote to the FDA about my pain problems. I have chronic pain, but I have had to learn to live with only OTC pain relievers for that because I have developed, over time, dangerous allergies to almost every opioid pain reliever. I used to be able to take large doses of Benadryl and take pain meds but even that does not work now. My biggest problem is unbearable pain. I also have Trigeminal Neuralgia - pain in the nerves that serve both sides of my face and the pain is so bad that it used to be called "suicide disease" before modern meds made the pain bearable and then means of treatment were found. Mine was totally under control until Last Sept. (08) when I suddenly experienced and inflammation and infection of the Trigemienal Nerve on the right side of my face. I cried, moaned and was totally out of my mind with pain. What got me through until treatment could help was Toradol injections and pills - which you can only take for a few days because of the danger of kidney damage - and Fentanyl patches, which carried me through those awful weeks. I had surgery and long term antibiotic therapy; a week in the hospital, 5 weeks of outpatient IV antibiotic treatment and here it is, June, 09, and I am still on antibiotics, but I haven't needed pain meds since October. Oh, and for 2 months I could not open my mouth. I said to the FDA that people like me and others with intractable pain should not have to suffer because some people are criminals or drug users. We should not have to jump through hoops or made to feel dirty somehow because we NEED pain meds! I don't need any heavy duty pain meds right now, but I will again and I want to know I can get them without having to suffer for days or weeks!!!!

Hi there, I know in Canada as a Pain Patient in British Columbia I'm lucky enough that my regualr GP is a member of the Cancer Respite team (Pain management of people in there last stages of death)  in the Hospital near my town.

Here, only certain Doctors are allowed to prescribe Methadone for pain management and all doctors have to fill out a special presription book for prescribing Opioid drugs.

Also when I started taking Opioids for my Chronic Pain I was made to sign a form that was an Oath "to not abuse" the drugs I am given, this also included a consent for any Doctor to preform a drug test on me at any time, without this Consent form I would not be able to attain pain meds from any Doctor. It also asked if any "Drug or Alcohol Abuse" was in my family to gage my level of possible abuse.

Only certain Pharmacies can distribute Methadone, and all is watched very closely by the " a special section of Physicians ". Everything you get prescribed is on computer and if you are seen as a person who goes looking for drugs from different doctors you get black listed.

Prescription drug abuse was rampant until they put all this in effect, I'm sure there are people who have figured out a way around all this, but it has really cleaned up the system.

Hopefully the American D.A. will go by these regulations, because it helps weed out the abusers from people who really need Opioids to help them cope.

I urge you to fight this...I live in Canada, our recently overhauled guidelines for long term opiate therapy are very close to the "REMS" proposal . Within a year of implementation, physicians became extremely paranoid and unwilling to perform the checks and balances the guidelines imposed. Entire clinics have "no narcotics" policies, and those of us who require long-term treatment are being referred to Pain Clinics (average wait time 9 to 10 months).

The Pain Clinics are like rehabilitation facilities; random urine testing (to prove that I'm taking my meds instead of selling them), random "repeat" questionnaires (at my first clinic visit I was  asked a series of questions relating to mine and my  family's (!!!)drug/alcohol/mental health history - what I didn't know was that I'd be forced to repeat the questionnaire, and my answers had better match...) 

I've signed a contract stating that I will only use "my" doctor for all my pain meds - even harmless stuff like my gabapentin and baclofen. I'm restricted to a single drugstore...I don't remember the other clauses. There are no refills on my meds; I have to return to the clinic every 21 days.

It gets worse. When my physician made the referral to the pain clinic, she signed a contract promising to take over the pain clinic's protocols once I was stabilized "EVEN IF THE PROTOCOL INVOLVES LONG TERM USE OF OPIATES". It couldn't be more clear, the pain clinics will not accept a referral without this understanding.

When I was discharged from the pain clinic after three months and 11 titrations, I blithely showed up at my GP appointment and my darling doctor (of fourteen years!)just shook her head and said she didn't believe in narcotics. I had only two days' worth of meds. She wouldn't even write me a script for ten days to buy me some time.... I reminded her that she had signed a contract but she had already turned her back on me.

I called the College of Physicians so they could straighten it out. I was told that the contract between the Pain Clinic and my GP had nothing to do with them and "we can't force doctors to prescribe narcotics." I'll never forget the contempt in that guy's voice. In his little mind he was talking to a druggie...

I went back to the pain clinic. I couldn't get an appointment until twelve days later though, so I had to ask my Neurologist to write me an Rx for the opiates. That was embarrassing; how can I credibly explain that my own doctor wouldn't write me the prescription? It doesn't exactly make me look good, and he's a new Doc who doesn't know me very well.

I lived in anxiety for those twelve days because the Director of the pain clinic explained that since I had been discharged, the Doc was under no obligation to take me back, she was doing what she could to settle the contract dispute with my GP but it was "just a formality really, because more than half the doctors who refer patients to us renege on the contract, they don't understand pain, they don't want the responsibility, and the College won't intervene."  I was absolutely floored. This is medical neglect on a grand scale, heartless neglect, and if my pain clinic Doc couldn't take me back (not out of neglect; he was simply unable to take on more patients because he was busy looking after those patients whose GP's had ditched them) I would have to wait for hours every 21 days at the ER. I would be forced to behave like a "Drug Seeker", and since I already knew what that felt like from my experience with my Neurologist I knew I would never get through it.

That sweet Doc did take me back, seven days ago. I guess I went a little off the rails in my comment because this experience is so recent.

I've spent the last week filing complaints, writing to politicians...(I'm a proud protester from the seventies), I'm also talking to the media.

No one should have to live in pain for a year while waiting for a clinic appointment. 

Physicians must be held to these bad faith contracts because there aren't enough pain clinics to serve the patients they simply dropped and will continue to drop because these "policies" frighten them, worse, these policies marginalize us.

Here is what I sent:

Thank you for this opportunity to express my great concern over the possibility of
further regulation of certain pain medications.  As a non-terminal chronic pain
sufferer, I rely on opiod pain medications daily to lessen the levels of my pain so
that I can live my life with a bearable amount of pain.   Seventeen years of
relentless pain (due to nerve damage from surgery, along with chronic migraines)
has not turned me into a drug addict.  Yes, I depend on certain medications to
decrease the pain, so that I can tolerate a certain level of activity and pain.  But, I
do not seek out drugs.  I do not buy drugs in any illicit manner.  A certified Pain
Specialist treats me for my chronic pain, and prescribes my medications.  I would
ask you to please consider the quality of life for the many, many pain sufferers
who need the medications their doctors prescribe, in order to manage pain that is
relentless, unbearable and life-altering.  Please, do not take away the only lifeline
many of us have that allows us to manage unimaginable, intractable pain that
came into our lives and will not be healed or cured.  The prospect of a future
without these medications is, indeed, a death sentence for some, and for others, a
sentence of unending torture.  Please do not make what is already a difficult life
more difficult by complicating access to necessary medical help. 

I also sent a letter to the FDA. I didn't save it. I'm worried about what they will decide to do. I just wanted to thank you Karen for letting us know about this so we could do our part and send letters.   Scooter

Regarding:  Docket No. FDA-2009-N-0143

It is my sincere hope, and plea, that the FDA will take into consideration the problems it will be causing for people who are in chronic pain and in true need of pain medications such as those on your list.  It will not solve the problems with abuse or addiction, it will only make life much more difficult for those who are honestly in dire need of help.

I have suffered from debilitating pain from a variety of causes: broken bones, Fibromyalgia, herniated discs in my upper and lower back, fractures of the vertebrae, nerve pain, and Multiple Sclerosis.  I am allergic to most opiates, including Morphine, and have been able to tolerate low doses of Methadone and Oxycodone/Roxicodone, which have been the ONLY medications that have given me any type of relief at all without severe reactions or problems.  If it were not for these medications, I would be unable to function at all, but due to these meds, I am able to accomplish most self-care (showering,  feeding myself, and most dressing, etc.).   My time in a wheelchair is also greatly reduced due to the help from these medications.  I have never been ‘high' from these medications, nor do I strive for that feeling.  I SIMPLY WANT RELIEF FROM THIS UNBEARABLE PAIN!

 While I still suffer greatly with these medications, the pain is lessened to a degree where I am not a drooling, inactive, severely depressed, totally dependent person.  (This is not an exaggeration!).  The pain I suffer (particularly the nerve pain) has been so severe that it renders me absolutely incapable of taking care of myself unless I take the Methadone/Oxycodone combination at regular intervals.  But, to get these drugs, I am made to go to monthly re-evaluations at the Pain Clinic, where I am subjected to unscheduled, random drug tests to prove I am not using any other type of drugs. And, I am forced to use only one pharmacy, which has been extremely difficult due to the recent Oxycodone ‘shortage', let alone the fact that I must rely on my spouse for all travel as I am not able to drive.  And,  I am required to keep these drugs under strict lock and key and there are absolutely no tolerances for getting any type of other pain medications from other doctors.  I must sign and abide by a written agreement that states explicitly the ‘do's and do not's" (which are many), while I am on these drugs.  Any variations of adherence causes me to lose my prescriptions, which also causes me to lose my ability to function in everyday life.

The doctors in this state are already afraid to write prescriptions for pain medications, due to the mistakes of others in the past.  The rules and regulations that doctors and pharmacists must adhere to are already extremely strict and there is wide-spread fear from most doctors of making a mistake and losing their license/ability to practice medicine. This creates a foreboding atmosphere for both patient and practitioner.  This is not a healthy situation to continually endure and if the FDA enacts even more rules/laws, the situation between patient and doctor will surely become even worse.

In my opinion, all this is creating is keeping the honest people in more of a hands-tied-behind-their-backs situation, and allowing the abusers to continue to do what they've always done.  Banning or limiting these medications will not keep the dishonest people from accomplishing their goals. It is would simply make life more difficult, if not totally impossible in some cases, for the law-abiding, honest people.

Please, please do not restrict patient access to proper pain medications by establishing even more rules and laws.  It is already difficult enough for the patients who truly in need, to obtain them.  Any of the proposals in REMS, will simply make it harder for them and the doctors, not for the illegal ‘high-seekers'.  If saving lives is what the FDA's goals truly are, restricting these drugs will not accomplish that goal.  I fear it might well do exactly the opposite and cause many honest, law-abiding people to either end their lives or seek alternative methods to obtain their medications.

Thank you for your time and for allowing us to speak our minds on this vital matter.

Sincerely,

Holly W

I understand the FDA is evaluating opioid pain medicines using Risk Evaluation
and Mitigation Strategies. I understand the concern which is felt concerning the rise in abuse, misuse, and accidental overdose of these medications. The FDA has always responded to crises like this one in ways which have on the whole have been helpful.

I am a patient with chronic pain resulting from an on-the-job injury. I am being followed in a Pain Clinic by the same professional and fill my prescriptions at the same pharmacy. I have discussed my prescriptions with the pharmacist and he assures me that three different people count the pills of this type of prescription. My injury resulted from a fall leaving me with compressed discs from C3 to C7. I underwent surgery in 2000. Unfortunately, my nightmare just begun. My life was a constant struggle to find a reason to live. It was so overwhelming! I was not able to do anything! I was unable to contribute to my family, my community and I became a burden to my family. In such, my husband and I ended a 25 year marriage. I have missed out on so much of my children and grandchildren's lives. I am currently taking Oxycodone (extended release) and Oxycontin and also use Lidoderm. I have suffered for many years, trying to find ways to cope with my pain, but I found nothing else but pain medications which would allow me some function from day to day. I have a flawless record of the correct use of these medications, and I keep them in a safe place to prevent abuse or accidental use of them. In fact, I use a weekly pill organizer for this type of medication and other medications to ensure that I do not take more than I am prescribed. I don't take nearly as high a dose as I should. I am so severly limited in my activities. In such, I am totally disabled. If new laws are passed which would make these medications too difficult for me to obtain, or which cause them to cost much more than they do now, I would be forced to spend the rest of my life bedridden and miserable. This would not be an option for me. I know my children and grandchildren would miss me. Get the point? I know I am not the only person who suffers on a daily basis. I am only 1 in many 1,000's.

For these reasons, I ask the FDA to be very sensitive to any changes on the prescribing of pain medications to patients who obtain these from medical professionals, as well as filling these prescribed medications from legitimate, licensed pharmacies. I know that some changes may be needed to curb the current problems with opioids. I hope that the FDA will find ways to do this which will not prevent patients with legitimate chronic debilitating pain conditions from obtaining the medications they so desperately need to live a half way decent way of life.

Thank you for providing me this opportunity. Please contact me if I can be of further assistance.

28 June, 2009

5:25:41 PM

Regarding:  Docket No. FDA-2009-N-0143

I wish to comment on the proposed idea the FDA has of the REMS proposal.

As a caregiver to my wife, who has severe, chronic pain from nerve damage, an other ailments, including Fibromyalgia and MS, I have watched her go from an active, vivacious, energetic, optimistic, artistic woman, to a bedridden, severely depressed shell of her former self, begging for her life to end because the pain is so severe and horrific.  It has been life-altering for me as well, to stand by her, helpless and watch her writhe in pain and cry like I've never heard before, simply because doctors are fearful of their licenses being revoked if they prescribe too many pain meds/the wrong type, etc.  This is NOT how medicine should work! 

Finally, due to her allergies to most pain medications, my wife found a combination of pain medications (Methadone and Roxicodone), which bring her pain level down enough that she can function somewhat on her own and the screams of desperation have ceased.  While she still must attempt to sleep upright in a chair, at least now, she is getting a couple of hours sleep per day/night, compared to none previously when the pain was ‘off the charts'. 

She must endure extremely strict rules in order to receive these medications,  and while simply trying to get these medications written and filled takes out of- the- ordinary acts, time and strict adherence to rules,  which makes life doubly hard for both of us, we are grateful that at least there is something that helps the pain.  However, she lives in fear of the doctor ceasing to write prescriptions for her, as the doctors in this state are terrified of the FDA/DEA and their threats to pull medical licenses if a doctor violates one of the strict rules.

We fail to see what benefits this  proposal of REMS will provide for her or anyone else suffering a life ruled by pain.  From where we stand, it looks as though it will simply make life unreasonably difficult, while still not attaining the goal of preventing illegal usage or over use/overdosing.  It will not stop illegal usage, it will only force law-abiding people to turn to illegal options in order to have any semblance of normalcy in their lives.  If they can't be treated properly & legally in a doctor's office, some will turn to illegal  sources rather than resort to the pain, hassle, stigmas and degradation they had before, while being treated in a ‘medical environment'.   

While I know my wife would not resort to illegal measures, I am not sure she wouldn't choose to not ‘exist' in that horrific level of pain again...she stated numerous times that what she was experiencing was truly ‘hell'. Neither of us ever wish to go through that again, and it's not necessary to do so as long as the doctors are allowed to treat patients individually and appropriately.  There is a lot to be said about "QUALITY of life", and I have to agree with my wife, that no one should have to endure such unbearable pain just  because some Government agency has decided to make even more rules that don't accomplish the goals they were designed to create.

Rather than seeking  to stop the illegal activity, why not find ways to ensure better treatment for patients in the first place?  Instead of being concerned with people using the drugs for recreational means, concentrate on finding ways for patients to not have their lives made more difficult simply because they NEED a medication? Focus on assisting patients getting the stigma of being treated like a criminal simply because they need pain medication, removed, and provide them the quality of life they deserve.  Unless you have personally experienced severe pain, or lived with someone who has, most people have little understanding or compassion for the situation. Please take notice of all the people who've written with pleas of simply wanting equality and good medical treatment, and not focus so much on trying to stop illegal activities and the ‘high-seekers'.  Please do not make what is already a difficult life more difficult by complicating access to necessary medical help and pain medications. 

Thank you for your time,

James Watson

I agree with the FDA's decision to develop Risk Evaluation and Mitigation Strategies. It is very important to understand and act on the misuse of drugs. It happens so often and so many people die from it. However, the FDA should not be able to ban drugs that also help so many people live and perform day to day because of other individuals who cannot control themselves. It is unfair to take a drug away that allows individuals to take part in their families' lives simply because others misuse them. These drugs are vital to the well being of many people and careful deliberation should take place before a decision is made.

There is so much of MVargas letter that I feel the same way, and feel so strongly about it that I have to copy some of it to put in mine, because she explains it so well. When the FDA considers implementing REMS for certain opioid medications, the agency is talking about the medications I take, the doctors who treat me, and the pharmacists who fill my prescriptions. Yet, when I read the call for public comment, some of the extreme policies proposed – requiring patient registration, dispensing medications only in certain settings, patient monitoring, providing access to medications only when prescriber, pharmacist, and patient are all enrolled in a program - the assumptions about the current state of pain care in the United States underlying these extreme proposals are so divorced from the reality experienced by patients and doctors that they left my mouth hanging open.
The FDAAA requires that elements of REMS enacted to ensure safe use must not be unduly burdensome on patient access to medication. When you consider requiring one more safeguard, one more certification, one more agreement that patients must sign, one more form of monitoring to which people living with pain must submit….these “one mores” must be considered in the context of the incredible and unprecedented scrutiny that legitimate pain patients already face. Our access to pain care is already unduly burdened – don’t let anyone tell you otherwise. Unlike any other kind of patients, we are required to submit to urine tox screens, we sign treatment contracts, we are turned away from doctors who are afraid to treat us because of the kinds of medications that lessen our suffering. We face a kind of legitimized discrimination that is based on fear.

It is clear from the call for public comment that the FDA is not considering implementation of REMS in my interests. I say this understanding it may be impolitic, but individuals living with pain can no longer stand by while concern for those who break the law trumps their right to care.
When they call for balance – balancing the moral imperative to ease suffering with concerns over illegal use.
Again and again those living with pain have been asked to do just one more thing in the name of balance – another contract, another form of monitoring – but already we cannot find doctors to treat us, we cannot find pharmacies to fill our prescriptions, – and now we are here talking about implementing strategies that are all about law enforcement and nothing to do with healthcare or compassion and, quite frankly, I’ve had all the “balance” I can take.
The truth is that the “balance” we have all talked about is a euphemism, if the only actions taken restrict access or depress prescribing practices. We tie the hands of legitimate patients and doctors in the name of balance and still it isn’t enough, because no matter how many barriers you put in front of my access to pain care, there will always be those who misuse or abuse drugs – if not pain medication, something else. So why in the world would any one want to make it almost impossible for someone who is in severe pain, and the only thing that will give us any relief at all, is to take our medicine and try like crazy to just have a close as possible a descent day. It is so hard to live with chronic pain every single day, every second of the day, and all of the other things that go with it, depression is one of the hard ones. Our everyday lifes are almost impossible to live, so please don't put more crap on our plate.

As a chronic nerve pain sufferer for the past thirteen years (since May 22, 1996), I can give you an honest answer to the benefits of opiads as they allow pain sufferers to rehabilitate back into society. The benefits are far reaching as they provide a means for the pain patient to rebuild a productive and meaningful life that encompasses family, work and community. The medicinal benefits unequivocally outweigh the misuse, abuse and accidental overdose of opiads. I know that if my doctor did not bring my pain under control my life would have ended over 13 yrs ago. I would not have been able to enjoy my marriage or see my children graduate and go on to further their education in University or College or marry and have children of their own. My chronic nerve pain has inspired one of my sons to become a physician. It is unfortunate that among the many vices in society there are those who solicit narcotics under the pretext of pain. I hope that this process that FDA is working on will help screen out such drug seekers. Also, I hope that the FDA will understand the benefit of long acting opiads which allow us pain patients to function in our employment. If I can be of any assistance please let me know. Thank you.

Ever since man discovered ingesting different substances made them feel "different", there has been substance abuse. There will always be someone wanting to alter how they feel, and drugs will be abused by some. But why should we punish those who have a legitimate need for opioids to be able to function because a few can't control their urges? Alcohol is a drug, for which there is actually no legitimate use other than to make us feel good.Why don't we make it illegal?It actually does more damage to individuals,families, and society in general than the smaller percentage (albeit much more highly publicized and villified)who abuse narcotics.If you make certain narcotics unavailable,those who will abuse them will merely find another substance to abuse and get their kicks from, while your only actual accomplishment is to cause extreme suffering in those who have done nothing wrong, other than be a victim of a physical illness or disease that causes them to be in such great pain that they are otherwise unable to function.  This is another fine example of our government attempting to "throw the baby out with the bathwater" Those who came up with this brilliant idea obviously have absolutely no personal knowledge or experience of what it is like to live with chronic pain 24/7.Those of us who know can tell you that even with narcotic medications available you can never completely kill the pain, it only becomes manageable/tolerable enough for us to be able to have our lives back and be able to function. Who is evil enough to take that away because a small minority abuses these legitimate medications?

I am fed up with being treated like a drug addict for severe, debilitating pain from my spinal surgeries. the last doctors took out defective hardware to lower spine.Waisted time, all the while I wait for them to get off the doctors backs so they will treat real pain patients that are litteral nervous wrecks with nurses looking with suspicious eyes as if i am a criminal in this horriffic pain state I am in. I wish that someone up there would open their eyes and say, well there are definate mri and scan evidence of severe deterioration-gee if nothing else has worked maybe some opiod therapy will work. gee, it worked before except my best doc retired and had to refur me out to another doc, He freaked out around 2-9-09, and I was dropped like a hotcake. No wonder pain patients have to puff a little weed to get some sleep. Its is almost as if the fed, ama etc are pushing pain patients into a state of desperation to almost plead someone for releif.God help you if you suffer pain----you just be a reasured drug addict, I have been praying that i am not what they seem. If I could take this away in some other country that understand what Pain is. Not abusing the meds using them for therapy.   

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