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pain meds to be banned by FDA??

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Posted 6/10/2009 5:25 AM (GMT 0)
Hello everyone,

I just got an e-mail from the pain foundation, and I guess the FDA wants to remove or limit access to pain medications. I havent read too much on it, but here's the link to what I got-  www.painfoundation.org  , sorry it this info has already been posted.

-hellokitty

Posted 6/10/2009 1:17 PM (GMT 0)

Thanks Kitty,  I signed and submitted!

XXOO
Patti

Posted 6/10/2009 6:22 PM (GMT 0)
All,
I don't have much time to post, but want to encourage everyone to please read the materials carefully. The proposal seems to be supporting that risk management of opioids (screening for abuse by psych profiling, U/A, record keeping, state/regional pharmacy databases, etc.) be newly implemented not only for patients using long-acting narcs, but for patients using the short-acting ones as well. I agree that it makes no sense to regulate only long-acting narcs. From everything I've heard, the shorter acting ones are more addicting. So I'm not sure where the FDA is going with this. There is more information on the FDA site, so I would encourage people to read that as well.
I agree that we need to communicate to our gov't officials that pain medications are a valid & important treatment for the management of certain neurological & pain conditions. I just think that perhaps the other points warrant some research. I haven't made up my mind yet about what the right path to take is, I just wanted to be sure that before anyone signed anything that they know they are agreeing that "risk management procedures must be in place for ALL opioid-classified prescription medications, not just the longer acting ones". :)

peace,
frances
Posted 6/10/2009 6:41 PM (GMT 0)
Kitty,
Thanks for posting this. I've not had a chance to read the materials yet as I've been pretty out of it this week. If I'm understanding Frances correctly (and Frances please let me know because not everyone may read through everything) signing the petition/proposal (not sure - I haven't read it yet) that the painfoundation.org is proposing would me we would be agreeing that more restrictions are placed on shorter acting narcotics like maybe vicodin or percocet, just as maybe they are on oxycontin? Am I getting it right, Frances? If that's the case I'm not sure I'd agree with it, as it would seem to make doctors even more frightened of prescribing some of these medications to us. And some people do have good PCP's who prescribe these medications, but get more reluctant to prescribe the longer acting ones.

But I DO NOT know if I'm reading Frances' post correctly. The devil is in the details, so it's important we know what we're doing here, and not just get sucked into some poitical process.

Thanks, Frances and Kitty for these postings.

PaLady
Posted 6/10/2009 9:05 PM (GMT 0)
yea, I havent signed anything yet, as my mind isnt thinking well right now cause I have been feeling very ill the past week, especailly today. But I thought it sounded interesting, so thought I would share what I found. When I'm feeling better I will read it in details, but right now all I can think about is trying not to vomit, I'm sure it's the heat, but if anyone wants to read it and expalin it in details with simple terms on here for me I would be thankful (hint hint, I love making everyone do everything for me lol). Well anyways, I hope everyone is safe and staying out of the heat.

-hellokitty
Posted 6/11/2009 12:06 AM (GMT 0)
I totally agree, Frances.

There was a thread a few months ago when the FDA first announced it was going to look at REMS for certain opiate medications.

The other thread on this topic is here, for a re-read: https://www.healingwell.com/community/default.aspx?f=16&p=1&m=1383812

Personally, I'm not entirely against what the FDA is proposing. Not all of the opioid stigma comes from drug abusers; I think quite a lot of the "danger" stigma associated with certain drugs (like Fentanyl patches, for example) comes from undereducated physicians prescribing certain drugs inappropriately and nearly killing their patients. Then the lawyers get involved and start advertising "Did ~insert narcotic drug~ harm you or a family member? You may be entitled to a zillion dollars in damages!" I believe the "danger" stigma and physicians' fear of lawsuits surrounding many of these drugs impedes the ability of chronic pain patients to obtain treatment far more than any REMS the FDA might put in place, especially since the cornerstone of what's been proposed so far has been a physician-related burden (obtaining and maintaining continuing education/certification to prescribe) not a patient-related one.

With that said, I do agree that everyone's input is valued - I just hope people think through what they write, rather than just regurgitating what the various advocacy organizations (on both sides of the issue) tell them they should say.
Posted 6/11/2009 2:17 AM (GMT 0)
welcome cameralinz
Posted 6/11/2009 7:28 AM (GMT 0)
The American Pain Foundation is encouraging those who use opiods for pain management to write a letter to the FDA. You're not signing anything. You're writing about your experience to the FDA, and telling them how important opiods are to you in managing your pain. You tell them that you don't want more barriers placed that make it more difficult to obtain your medications. I sent my letter two days ago. The deadline is June 30th. The FDA is hearing all arguments until then. If you go to the APF's website, they have a link that makes it easy to send your letter. You write your own letter. It's not pre-written. I wrote in protest of what the FDA is proposing, which is insane. There's never been a worse time to be chronic pain patient.

Posted 6/11/2009 3:34 PM (GMT 0)
DiLane,
I'm still kind of out of it from some medical procedures this week, but I wondered if you could share a little of what the FDA is proposing in your view. I hope to be able to read up on this and respond before June 30th, but it won't be this week! I'd also like to hear what others are thinking - not getting any arguments going, just some of your thoughts. I guess my initial thought is anything that adds regulations right now is going to work against us. In theory it might sound good, but in practice doctors are already skiddish enough. But I've not read all the material.

Thanks,
PaLady
Posted 6/11/2009 4:20 PM (GMT 0)
I replied to the email. My position is this (and you don't have to agree with me):

The FDA does not have a good track record of reducing drug abuse through their controls. I am all for controlling drug abuse but NOT at the expense of the patients like us who depend on an uninterrupted supply of medications. I personally don't believe the proposed actions will substantially reduce abuse of opiods. It WILL impose even more reporting requirements on the docs and more monitoring of the patients. I don't want the government any more involved in my health care than they already are. They didn't do such a great job with Medicare and Part D with its "donut hole" that most people don't know about or can't explain. Is this next program going to keep opiods out of the hands of the illegal drug market? Please explain how that one works. It looks like they are going hunting for their prey with a shotgun instead of a rifle. For the little good this program might do it will impose a tremendous burden on the medical providers and (particularly) the chronic pain patients. Maybe they should turn to the private sector for a solution. Businesses seem to be more objective in solving complex problems than the government. It seems to me the money and effort would be better spent on more agressive law enforcement and implementation of existing controls. This drug problem is not going to be solved by passing more legislation and, folks.

With that I will end my rant. Sorry if I got anyone's dander up but that's the way I feel.

Modelmaker
Posted 6/11/2009 4:24 PM (GMT 0)
Modelmaker,
Thanks for posting. You didn't get my dander up. I think as long as we keep the discourse civil (as yours was) this is a useful discussion. At least, IMHO.

PaLady
Posted 6/11/2009 4:33 PM (GMT 0)
PALady,

I am glad you are feeling a little better after your procedures. I know that can knock you down for a few days until your system returns to normal.

How do you feel about the proposed controls?

Modelmaker
Posted 6/11/2009 6:24 PM (GMT 0)

PAlady said...
DiLane,
I'm still kind of out of it from some medical procedures this week, but I wondered if you could share a little of what the FDA is proposing in your view. I hope to be able to read up on this and respond before June 30th, but it won't be this week! I'd also like to hear what others are thinking - not getting any arguments going, just some of your thoughts. I guess my initial thought is anything that adds regulations right now is going to work against us. In theory it might sound good, but in practice doctors are already skiddish enough. But I've not read all the material.

Thanks,
PaLady

Honestly PaLady, there's simply too much to type. If you go the The American Pain Foundation's website, it's all there. Tons of reading. I'm not well enough to type a great deal. I'll post my letter to the FDA, which was the most I typed in a while.

----------------------

 

I am a very sick woman. I have severe cervical spinal stenosis, as well as other spine problems. I also have osteroarthritis throughout my entire body. I am also afflicted with Fibromyalgia, which is so bad, that I often have trouble walking. All of my health issues are backed up by MRIs and by seeing specialists the reputable hospitals.
I am in severe pain. For that reason. I am on opiod therapy, and this helps me a great deal. Oxycontin has given me my life back. Without this medication, I most certainly would be bedridden, or worse. I am not pain free, and I still suffer, but at least it's manageable because of the medication. My pain is at the lower end of the pain scale, as opposed to passing 10 with me screaming my heart out.
Oxycontin is a good pure drug, and it only hurts a person if they abuse it.  I am a very compliant patient. I signed a pain contract. I take my medications as directed. I never run out early. I have no addiction issues whatsoever. I see my doctor on a monthly basis, and I submit to random urine screening. There has never been an issue with those drug tests.
It would be grossly unfair to make people like me suffer, and even die, because some people abuse prescription medications. There has to be another way. Please, I implore you, leave Chronic Pain Patients alone. We suffer terribly, and don't need any additional barriers put up that make getting our pain medicine even more difficult than it already is.
These opiods are my lifeline, and offer me some quality of life. I would certainly die without pain management. The human body was not made to withstand the stress of severe pain. I am begging you, please show compassion for people who are only guilty of having severe chronic pain.
Thank you for your time.

Posted 6/11/2009 7:21 PM (GMT 0)
Hi
I was reading the proposal. And though it "looks" like it could use a lil brushing up... I do support a "regristry". We have this for our youngsters here in New Mexico. I know that some states do the same young and old, alike.

I would like to see a nation wide registry of sorts. So far our local registry has saved me alot of time and effort and no longer need to track down records. They even have my vaccinations in there....

But!!! I would like to see more restrictions on who has access and when and what "part" of records. Hopefully, this matter will be explored further (hopefully by an outside agency that doesnt have connections to either side of this issue) and in more detail before anyone in a position of power is able to set it in stone.

*huggs*
dani

p.s. keep us posted if you find anything new *huggs*
Posted 6/11/2009 7:30 PM (GMT 0)
Businesses seem to be more objective in solving complex problems than the government. It seems to me the money and effort would be better spent on more agressive law enforcement and implementation of existing controls. This drug problem is not going to be solved by passing more legislation

You said it! Honestly i was suprised to see such a proposal without any agressive enforcment of laws and legislation that are already in place... well, except florida.
*huggs*
dani
Posted 6/11/2009 7:57 PM (GMT 0)
I think there's one very important fact that's consistently overlooked: the mandate of the FDA is drug safety. They don't have a track record of enforcing regulations that prevent drug diversion and abuse because that's not their job - enforcement falls under the mandate of the DEA.
Posted 6/12/2009 8:25 AM (GMT 0)
I recently read that the DEA and FDA are joining forces to combat the probleme of prescription drug abuse. I don't remember where I read it, but I'll try to find it. It's getting scary out there.

Posted 6/12/2009 9:14 AM (GMT 0)
So much for my two cents in this. I tried to add my comments but it did not go through. Just took me to a privacy page after I spent 10 min. commenting.

Ugggg
Posted 6/12/2009 6:15 PM (GMT 0)

Scarred_for_life said...
So much for my two cents in this. I tried to add my comments but it did not go through. Just took me to a privacy page after I spent 10 min. commenting.

Ugggg

The same thing happened to me, I think. You may have clicked on New Topic instead of Post Reply. Go to your profile page, and then to where your last posts are. Click on it. Copy and paste those comments (that you lost) onto this thread, but be sure to click on Post Reply on this thread. Those buttons sure are close together. Good luck.
Posted 6/12/2009 9:37 PM (GMT 0)
DiLane,
I wouldn't be surprised at all to hear that. The FDA has been overstepping its mandate in a few areas in recent years, IMHO, but I won't go into that is they're unrelated to this forum. But I suspect you're right, Di.

PaLady
Posted 6/12/2009 10:48 PM (GMT 0)
What Bionoc said hits directly with what my pain mgt dr told me. I posted this previously and will again. We were discussing the DEA visits during one of my appts. She tells me the DEA visits the PCP's more than actual pain mgt drs and pump patient drs. She says the reason is sloppy practices in records keeping by the PCP's. She said she has seen this first hand when reviewing records sent to her for a referral of a patient. She says so many of the drs could save themselves so much grief if they would just slow down long enough to document their charts the correct way. Susie
Posted 6/13/2009 1:06 AM (GMT 0)
Wow! What a fantastic discussion!
I thought the same thing as many of you about why can't the DEA just regulate the drugs more if they feel that is needed? Having working in public positions before, I have first-hand experience with the confusion & aggravation that comes from having to produce huge amounts of useless paperwork for multiple agencies. The FDA posted the "mandate" they feel applies to them assuming this responsibility & like everything else, the statement is just vague enough to allow a host of interpretations.

PA-
To clear of my understanding of the FDA proposal: they want to go from not regulating opioid abuse, to regulating it in regards to long-acting narcotics only because they apparently hold the view that long-acting narcotics are more addicting. They specifically reference Oxycontin.
The pain foundation site gives "talking points" to include in a conversation with or letter to the FDA. Their viewpoint is that it would be better off to not include only long-acting narcs, but also the short-acting ones. That is why I said I didn't even understand why they would include only the long ones b/c from everything I've ever heard, the short-acting ones are more addicting. Now, I don't know for sure whether or not that's true, but based on people I know, it seems to be true. So, the FDA program, for example, wants to impose additional regulations on Duragesic patches, but not on the fast, short-acting versions of the same drug, Actiq & Fentora, both of which, at least in my geographic area, are abused & sold on the street far more often than Duragesic is. It makes no sense.
The pain foundation's position is that by making only a certain type of narcs subject to harsher regulations, that is will just end up forcing those patients onto shorter acting narcs b/c their doctors (or the patients themselves) may not want to put up with all the nonsense. They say that some docs may stop writing long-acting narcs altogether (personally, I think that any docs who choose to put patients on one drug over another just b/c it's easier, even if it is not a good medical choice for that person, ought to have their license yanked. It is lazy & dangerous & I am saddened to hear that they got feedback from even one person that such a thing could happen.

Personally, I am strongly in favor of more regulations, but I think they ought to come from the DEA. The DEA has the structure needed to respond to changing trends in drug abuse & diversion, the FDA does not. FDA regulations & determinations are very rarely changed or reversed, from what I've seen. And that's usually a good thing. We don't want unsafe drugs coming back on the market just because it's the popular thing to do. But abuse trends change all the time. An agency that is connected with law enforcement & able to monitor trends would really be better suited for that duty. Yes, there are standard behavioral indicators for abuse & perhaps we would do well to try better to identify potential abusers before even a single script is written, I'm just not sure this is the way to go about it. Perhaps I'm just entirely too jaded by things I've seen, but it seems that when addicts are in pain, regardless of whether or not they are being seen by a doctor, they tend to find ways to get their hands on narcs -- even if they've never used narcs before. That's not to say I think we should give doctors a free pass, just that I think any "solution" must address all of the components that can contribute to abuse or diversion -- not just doctors, but suppliers, distributors, patients & end-users as well.

Well, I've probably said too much already, but I will definitely keep following this thread. It is great to hear everyone's perspectives & experiences on this important issue.

frances
Posted 6/13/2009 2:12 AM (GMT 0)
The DEA needs to get the hell out of the doctor/patient relationships. Let doctors practice what they studied for years and years. They're the ones with the medical degress, not the DEA. Many doctors are afraid to prescribe narcotics to a suffering patient, out of fear of the DEA. I've had two of my own doctors tell me that. "I have to be careful."  There are no doubt some rotten apples, as that happens in every profession. However, the DEA goes after doctors, often on trumped up charges. Doctors, being worn out because they've had everything they own taken away from them (seizure and forfeiture law), including their licenses, often make a plea bargain. It's David and Goliath.

This errodes the doctor/patient relationship. Anything a patient says or does can be construed as "abbhorent behavior". Don't ask for a drug by name, don't run out of meds early, don't do anything. This has created a Chilling Effect. Opiodphobia is very real. It's unfortunate that the medications that help suffering people are also abused on the street. As a result, chronic pain patients are often untreated or undertreated, and I know this because I'm one of those people. Patients are often forced to jump through painful hoops with these "procedures". People are forced to suffer because they're guilty of being a chronic pain patient. When opiods are prescribed and taken as directed, they're safe. What happens is parents have kids who get their hands on Oxycontin to get high, and they overdose and die. Those parents then pound their fists to get Oxycontin taken off the market because it's a killer drug. Oxycontin is not a killer drug when taken as prescribed. Most clear thinkers know the difference between addiction and dependence. I depend on my opiod medication the same way my husband depends on his diabetes medication. I could provide at least a dozen links to articles about this that appear in the NY Times, AARP, USA Today, and many other reputable sources. This a a very real problem. Millions are suffering needlessly. No, the last thing we need is more DEA oversight. They're thugs.

 

Posted 6/13/2009 5:28 AM (GMT 0)
I think DiLane that you speak more to my sentiments about increased regulations, although again, I haven't read them. But just the notion of more regulation of these medications, especially without some equally strong promotion of adequate treatment for CPP's and how overreaction to diversion can result in so much suffering, makes me very suspicious. There are already a lot of laws on the books that can be enforced. I can see tracking systems being instituted in states that don't have them, so that people can't pharmacy shop, for example, but anything that further scares off doctors from treating pain - acute or chronic - scares the heck out of me.

Some things may sound good in theory, but in practice....too many of us already have difficulty getting good pain management. I like the way you put it, DiLane, about less interference with the doctor/patient relationship. What true "relationships" are left, that is.

None of this is meant to offend anyone, just my thoughts as one who is challenged to find good PM, like many people here.

PaLady
And thanks, Frances, for taking the time to explain your thoughts. They are worth pondering also.

Post Edited (PAlady) : 6/12/2009 11:31:15 PM (GMT-6)

Posted 6/13/2009 2:46 PM (GMT 0)
It has taken me three days to get thru this thread.  By the way its a wonderful thread!!!!  I havent went to the painfoundation site yet but will today.

 

Did anyone read the news about Danny Gans?  He died from taking Hydromorphine.  This happened just the other day.  They have been questioning the doctor who prescribed it.  This is the sum of the story.

 

Gans had a shoulder injury went to the doctor.  Doctor gave him the pain med.  Next visit Gans said he didn't like the medication but refused any other pain med saying it could weaken his vocal cords. (he worked on the Vegas strip as a preformer)  Months later he went back for another follow up said his shoulder still hurt but once again refused pain meds. Opted for a conservative approach to medical treatment.  Now just weeks later they found him dead from taking the hydromorphin.

 

The county coroner has said the cause of the 52-year-old singer and impressionist's sudden death was "acute hydromorphone toxicity" and "chronic pain syndrome." He ruled out drug abuse.

 

They also looked in the registery and found out he didn't have any current scripts for it also.  He used the old one.

Here's my view.  Great have a national registry for scripts on meds.  I'm not worried I only take what is prescribed.  Most of us would agree on that one.  Then a person can only get an X amount of scripts.  The DEA and FDA never win on drug abuse.  Abusers will find them regardless restrictions only affect us not them.  They don't follow the rules we are the ones who do.  Abusers want an easy fix they won't stay around for procedures and tests.  Anymore restrictions will just make it harder on us who need them and will NOT effect the abusers.  My fathers girlfriend is an addict and she lets my dad jump through all the hoops so it doesn't bother her.

My main problem with all this is government has to much say in our daily life as it is.  Now the government wants to make our doctors scared, make us suffer and decrease our quality of life because of the people who abuse and don't even get there meds through doctors most the time.  My husband will freak out when he hears about this.  He is so patrotic through and through but he passionatly believes the government needs to butt out.  He thinks they are trying to get us to rely on them for everything we get in our lives.  But meds shouldn't be in that bracket!

If I didn't have my meds I wouldn't be able to work, sleep or have quality time with my family.  I don't mind having to jump thru hoops with procedures for I found out one of them gives me about 25% relief.  Its take alot of time out of my schedule, changing around work and making sure someone can drive me home every monday.  But any relief is better then none in my book.

Ok thats more then two cents worth...lol

Laurie

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