FDA to reevaluate the use of opiate medications

[Skel]

I’ve been told that the FDA is taking the comments people write in very seriously. While I’m not sure how seriously they’re taking them, I really do hope that everyone who believes these medicines should be able to be prescribed by doctors to let the FDA know via the “Comment Now!” button on the site http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001 (same site in the OP). I’d hate to see people I personally know who suffer not able to get the medicines to help them because someone is letting emotion and politics rule.

[xj0hnx]

Originally Posted by Skel

It has many flaws, the most glaring is attempting to apply new label classifications of “noncancer” pain vs “cancer”. Doing that would suggest the doctor is to treat the same condition (something like a compression fracture) differently because of what caused it. Just because a tumor didn’t cause it doesn’t mean it hurts less.

They’ve also just chosen the dose and duration limits by random from what I’ve found, and have nothing to support it by scientific evidence. In fact during my research on this topic I found there are many examples where the doctors involved with POST ignore any data that conflicts with what they’re attempting to push.

I thought they were already doing the "cancer only" drugs, but a friend of mine has some pretty terrible deforming arthritis and he gets Fentanyl patches, and freaking hydrocodone, which barely gets him through the day, I can't imagine what his life will be like if they take even that away from him. The whole idea of only being able to get pain killers that actually work if you are dying of cancer is fucking insane. Pain exist outside of just cancer. I've been a CPP for five years, and if this bullshit happens my, and many others, quality of life will go down the tubes.

Originally Posted by Genx87

Just think it could be more advantageous from a pain management perspective to live in Afghanistan than the United States. What progress we are making.

How fucking sad is that?

Originally Posted by DCal430

Strange things some states require a prescription for codeine a weak opioid but others allow it OTC with no prescription.

The only formulation that is possible to get OTC codeine is the Schedule V oral preparations, and that is all but impossible to find any pharmacy that still will sell it OTC, and if they do, you have to show ID, sign in a records book, and are not allowed to buy it again for something like 30 days.

By implementing the label changes proposed in this petition, FDA has an opportunity to
reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed
opioids.

No, no it won't change a thing. So what would they do for "moderate" pain? Who's going to determine what something as subjective as "moderate" pain is? Why such as arbitrary maximum dose of 100mg morphine per day equivalent? That's not really that much, especially if you've been on it for a few years.

All that said there is a real problem with prescription abuse in this country, places like Florida, and it's pill mills give all doctors/patients that prescribe/take opiates a bad name. This is one of the things that fuels my view that all drugs just need to be legalized. I know how much I need to get out of pain, why shouldn't I be able to, as a free, responsible American, go into a pharmacy and buy a real pain killer that works? Hell most of the diversion is BECAUSE people that need them can't get them.

[RocksteadyDotNet]

Originally Posted by ichy

Great, so now more patients with legitimate pain are going to be made to suffer in order to protect junkies from themselves.

This.

If people want to get high let them! Who gives a shit?

You guys are so obsessed with stopping people from doing anything you consider 'bad' or 'immoral'. Even if it means hurting people who actually need these drugs.

Some people want to get high. There's nothing wrong with that. That's just how life is, you're never going to stop it.

[waggy]

Originally Posted by xj0hnx

I thought they were already doing the "cancer only" drugs, but a friend of mine has some pretty terrible deforming arthritis and he gets Fentanyl patches, and freaking hydrocodone, which barely gets him through the day, I can't imagine what his life will be like if they take even that away from him. The whole idea of only being able to get pain killers that actually work if you are dying of cancer is fucking insane. Pain exist outside of just cancer. I've been a CPP for five years, and if this bullshit happens my, and many others, quality of life will go down the tubes.




All that said there is a real problem with prescription abuse in this country, places like Florida, and it's pill mills give all doctors/patients that prescribe/take opiates a bad name. This is one of the things that fuels my view that all drugs just need to be legalized. I know how much I need to get out of pain, why shouldn't I be able to, as a free, responsible American, go into a pharmacy and buy a real pain killer that works? Hell most of the diversion is BECAUSE people that need them can't get them.

your post nailed it. but formating sucks and i just got a cup of coffee so i'm not going to try to make this look nice LOL

there are days when i have a hard time getting out of bed. while i don't take many pain meds (my sister got hooked on them years ago) When i do need them it's nice to get them.

as it is with the feds going after pain docs they aren't giving shit away. sure in very rare cases they will. it's getting to be a sad situation when you have people not being able to get pain meds having to resort to illegal things (one sub-forum of a pain forum i get on tells what you can do) or if yo don't want to resort to that they end up either crippled or going to the ER.

it's fucking insane.

[Darwin333]

People in chronic pain already have a very hard time getting proper relief due to doctors being scared of the Feds. This is an issue caused primarily by the absurdly obvious (and should be very easy to track) pill mills that are a very small minority of the doctors prescribing opiods but prescribe a huge portion of them.

[BoberFett]

Clearly, the problem here is small government.

[xj0hnx]

Originally Posted by Darwin333

People in chronic pain already have a very hard time getting proper relief due to doctors being scared of the Feds. This is an issue caused primarily by the absurdly obvious (and should be very easy to track) pill mills that are a very small minority of the doctors prescribing opiods but prescribe a huge portion of them.

Yip, and even though they are a very small part of the equation, they are front and center of every "Prescription abuse EPIDEMIC sweeps across the NATION!!!!" and of course it is fueled by the hundreds of pill mills on every corner, next to your kids school, and people are dropping like flies!!! OMFG!!! I recently saw a story like that in our local paper, a huge bottle of pills spilled across the graphic stating that the epidemic had arrived. So ridiculous.

[PokerGuy]

Typical stupidity, trying to put things in place to cure the symptom rather than address the problem itself... and in the process screwing up something else. Sounds pretty much like a government agency, I'm sure the FDA will get on board with it.

[Skel]

Originally Posted by xj0hnx

Yip, and even though they are a very small part of the equation, they are front and center of every "Prescription abuse EPIDEMIC sweeps across the NATION!!!!" and of course it is fueled by the hundreds of pill mills on every corner, next to your kids school, and people are dropping like flies!!! OMFG!!! I recently saw a story like that in our local paper, a huge bottle of pills spilled across the graphic stating that the epidemic had arrived. So ridiculous.

When I first started looking into this and came across that “salem-news.com” site I was caught off guard by the author “Marianne Skolek”. I know I shouldn’t have been surprised, but reading her obvious personal crusade against all things opiate I kept wondering where the other side of the story was. The comments on her articles made more of a whole story picture than her “news” stories. In all of them the theme of saving the children from the drugs was front and center. In the one article of hers that I linked in the OP, a chronic pain sufferer was told to stop being a baby and was repeatedly asked if he’d be happy if “another thousand families bury their kids”. That’s what they’re using to push this agenda, the fear that everyone’s kids will OD and die. Forget that people need them to have what little quality of life they have, that’s all them being babies.

[xj0hnx]

Originally Posted by Skel

When I first started looking into this and came across that “salem-news.com” site I was caught off guard by the author “Marianne Skolek”. I know I shouldn’t have been surprised, but reading her obvious personal crusade against all things opiate I kept wondering where the other side of the story was. The comments on her articles made more of a whole story picture than her “news” stories. In all of them the theme of saving the children from the drugs was front and center. In the one article of hers that I linked in the OP, a chronic pain sufferer was told to stop being a baby and was repeatedly asked if he’d be happy if “another thousand families bury their kids”. That’s what they’re using to push this agenda, the fear that everyone’s kids will OD and die. Forget that people need them to have what little quality of life they have, that’s all them being babies.

Wow, I haven't dug into her story yet, but the first thing I found tells me pretty much all I need to know about her.

This site is dedicated in memory of my daughter, Jill Carol Skolek. She was born on February 26, 1973. She was killed on April 29, 2002 because she had the misfortune of being prescribed OxyContin. This site is also dedicated to all the families who have experienced devastation either through death or addiction of a loved one from OxyContin. This site has nothing to do with grieving. It has to do with justice.

So because her dumbshit daughter was too stupid not to abuse drugs, and overdosed, the rest of the world should suffer? Fuck that cunt. I'm not even going to link to that twat's website because it is so disgusting. She is just like the morons that blame guns for killing people, and want to sue gun manufacturers for other people stupid actions instead of putting the responsibility where it belongs, on the individual.

[nanette1985]

Originally Posted by waggy

no suprise really. anyone that has chronic pain or knows anyone in chronic pain knows it has been headed this way for years.

they would rather have a person sufer in pain unable to do anything then risk them getting hooked. they keep talking about quality of life of addicts. yeah not being able to do a damn thing because you can't move is any better?

if you read some pain forums (yes there are some) you would be amazed what some people have to do. all it is doing is turning those that need it into criminals to they can survive the damn day

One important thing here is that there are all of these new arthritis drugs that are extremely expensive. I'm convinced that it is the drug companies that are responsible for the intense doctor harassment. If you make MD's terrified to prescribe opiates, then you can get those MD's to prescribe something else.

Rheumatoid arthritis since childhood. I know pain & pain forums.

My other point is that they are redefining addiction. If you take oxycontin for pain and the oxy works and you take it every day because you need it to function, then you are now addicted. Imagine if you were considered to be addicted because you take insulin every day to control your blood sugar.

[Saint Nick]

Originally Posted by hal2kilo

Synthetic cananbinoids are looking promising as a new tool in pain management.
http://www.google.com/url?sa=t&rct=j...k5dwwcL6kDNniw

I'm sorry but this is just straight up fucking stupid. Why make a synthetic product when a naturally occurring one is available. I can't wait to move out of this ass-backwards country.

[waggy]

Originally Posted by nanette1985

One important thing here is that there are all of these new arthritis drugs that are extremely expensive. I'm convinced that it is the drug companies that are responsible for the intense doctor harassment. If you make MD's terrified to prescribe opiates, then you can get those MD's to prescribe something else.

Rheumatoid arthritis since childhood. I know pain & pain forums.

My other point is that they are redefining addiction. If you take oxycontin for pain and the oxy works and you take it every day because you need it to function, then you are now addicted. Imagine if you were considered to be addicted because you take insulin every day to control your blood sugar.

not to mention those meds don't work..

[waggy]

Originally Posted by Saint Nick

I'm sorry but this is just straight up fucking stupid. Why make a synthetic product when a naturally occurring one is available. I can't wait to move out of this ass-backwards country.

because they can't allow you to use something they deemed illegal even if it will help thousands live a normal life.

[piasabird]

My mother was being treated for back pain that was so bad that it made life unbearable. Over time she became addicted to Oxy codone and Oxy Cotton. It was really difficult to dealwith imagine having all this pain from a bad Scrailliac and a bad back and the pain shooting all the way down into your legs. Then when you come down from the affects of the oxycotton, you also go into withdrawls and cold sweats and the pain of the withdrawl affects. So they stopped giving her oxycotton and went to methadone which is what they treat addicts with. They also started using a pain patch. However, using different drugs enabled her to have a lot less pain and facilitated a healing process.

Without opiate pain killers, many people would be in a lot more pain. However, I think they should take oxycotton off the market. It is too addictive and too dangerous a drug. It is like doing heroine. To those people that have become addicted to oxycotton I have become a little more understanding.

[feralkid]

Originally Posted by DCal430

Strange things some states require a prescription for codeine a weak opioid but others allow it OTC with no prescription.

What states are those?

[waggy]

Originally Posted by piasabird

My mother was being treated for back pain that was so bad that it made life unbearable. Over time she became addicted to Oxy codone and Oxy Cotton. It was really difficult to dealwith imagine having all this pain from a bad Scrailliac and a bad back and the pain shooting all the way down into your legs. Then when you come down from the affects of the oxycotton, you also go into withdrawls and cold sweats and the pain of the withdrawl affects. So they stopped giving her oxycotton and went to methadone which is what they treat addicts with. They also started using a pain patch. However, using different drugs enabled her to have a lot less pain and facilitated a healing process.

Without opiate pain killers, many people would be in a lot more pain. However, I think they should take oxycotton off the market. It is too addictive and too dangerous a drug. It is like doing heroine. To those people that have become addicted to oxycotton I have become a little more understanding.

i would rather get addicted to oxy and get off then deal with pain daily for years.

the choice is fucking easy.

[piasabird]

You could take the same illogical reason for dailt drug use for things like High blood pressure, sugar pills, Diabetic agents, Hay Fever, ADHD, etc.

[piasabird]

Methadone can work for the pain also. It is probably cheaper also. The problem is most doctors will not prescribe it. They were using it in my moms rehab/nursing home.

[xj0hnx]

Originally Posted by nanette1985

One important thing here is that there are all of these new arthritis drugs that are extremely expensive. I'm convinced that it is the drug companies that are responsible for the intense doctor harassment.

Doesn't compute, pretty much every major drug company has a version of an opiate pain killer.

My other point is that they are redefining addiction. If you take oxycontin for pain and the oxy works and you take it every day because you need it to function, then you are now addicted. Imagine if you were considered to be addicted because you take insulin every day to control your blood sugar.

Except it doesn't make you addicted, it makes you dependent, there is a difference, and that's where a lot of problems begin. Someone who is physically dependent on opiates can live their whole life and not display addictive behavior. Those behaviors usually manifest when the patient is taken off, or their tolerance becomes higher.

Originally Posted by piasabird

My mother was being treated for back pain that was so bad that it made life unbearable. Over time she became addicted to Oxy codone and Oxy Cotton. It was really difficult to dealwith imagine having all this pain from a bad Scrailliac and a bad back and the pain shooting all the way down into your legs. Then when you come down from the affects of the oxycotton, you also go into withdrawls and cold sweats and the pain of the withdrawl affects. So they stopped giving her oxycotton and went to methadone which is what they treat addicts with. They also started using a pain patch. However, using different drugs enabled her to have a lot less pain and facilitated a healing process.

It's OxyContin, not Oxycotton.

Without opiate pain killers, many people would be in a lot more pain. However, I think they should take oxycotton off the market. It is too addictive and too dangerous a drug. It is like doing heroine. To those people that have become addicted to oxycotton I have become a little more understanding.

BS. It is no more addictive, and develops no more a physical dependence than any other full agonist opiate. There are other opiates out there that are way better such as hydromorphone (Diluadid), Fentanyl, etc ...Oxy just gets a bad rap because of people like that cunt on the earlier mentioned website, and because Oxy managed to get in the public eye a lot bigger than others. Funny thing about it, you see "OxyContin this, and OxyContin that, but you never see anyone ragged on about Percocet, but yet it's the exact same drug, oxycodone, the only difference is OxyContin is an extended release, while Percocet is a formulation like hydrocodone, mixed with APAP, and usually in smaller dosages since it's instant release.

Originally Posted by piasabird

Methadone can work for the pain also. It is probably cheaper also. The problem is most doctors will not prescribe it. They were using it in my moms rehab/nursing home.

It's a lot cheaper, and it has become more popular recently for pain management now that it is stepping out of it's "junkies only" shell.

[Mr. Pedantic]

Originally Posted by Skel

Currently there is a petition in front of the FDA to reevaluate the use of opiate medication. The group “Physicians for Responsible Opioid Prescribing” or POST is requesting that the use and ability to prescribe the medicines be changed in an attempt to deal with the abuse that happens with these kind of medications. Currently the FDA is allowing public response to this petition.

You can read the petition and comment here.
http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001

It has many flaws, the most glaring is attempting to apply new label classifications of “noncancer” pain vs “cancer”. Doing that would suggest the doctor is to treat the same condition (something like a compression fracture) differently because of what caused it. Just because a tumor didn’t cause it doesn’t mean it hurts less.

The deal with the FDA is that evidence of a specific condition requires evidence tailored for that specific condition. For this example, even though cancer pain is effectively treated with opioids, there is no good evidence to show non-cancer pain is the same (except, perhaps, for tramadol). Therefore, the FDA shouldn't approve stronger opioids for non-cancer pain.

Of course you're right, it doesn't hurt less just because it's non-cancer pain. But different pain medications have different mechanisms of action, and not all painkillers work for all types of pain. In the case of non-cancer pain, a lot of chronic pain is caused by either neuropathic or psychosomatic mechanisms, which aren't as amenable to opioids as cancer pain.

They’ve also just chosen the dose and duration limits by random from what I’ve found, and have nothing to support it by scientific evidence. In fact during my research on this topic I found there are many examples where the doctors involved with POST ignore any data that conflicts with what they’re attempting to push.

I think the idea with the low dose is that it's supposed to curb opioid tolerance.

The American Academy of Pain Medicine has written a response here (It’s a PDF, but you can find their site at http://www.painmed.org )
http://www.painmed.org/aapm-response-to-prop-petition-press-release.pdf

Their response doesn't actually say anything useful.

While I strongly agree that there should be tight regulations on such medications, the proposed changes are a bit overreaching and will most likely take the medications out of the hands of people who really need it. I’ve dealt with a lot of people that deal with chronic pain, and it’s not their fault someone else abuses the medications. To punish them by saying it’s the medication’s fault that some idiot became an addict and killed themselves is insane to me.

If you're interested in the evidence, the World Health Organisation says, and I quote:

"Opioid dependence develops after a period of regular use of opioids, with the time required varying according to the quantity, frequency and route of administration, as well as factors of individual vulnerability and the context in which drug use occurs. Opioid dependence is not just a heavy use of opioids, but a complex health condition that has social, psychological and biological determinants and consequences, including changes in the brain. It is not a weakness of character or will."

[SandEagle]

marijuana is the miracle drug to end all diseases
http://forums.anandtech.com/showthread.php?t=2271947

[nanette1985]

Originally Posted by waggy

not to mention those meds don't work..

I've heard that. But a drug not working has never stopped a drug co. from aggressively marketing it.

[OCGuy]

This state already figured out that a bunch of stoned sick people is better than a bunch of vicodin heads.

[TraumaRN]

I will say as an ER nurse something needs to be done. I know some of you laugh at the headlines talking about prescription opiate drug abuse but it IS a problem. And while I'm posting on my phone and can't find the link the rate of RX opiate abuse has skyrocketed in the last few years. We have people drug seeking daily in my ER. The problem is the drug abusers and seekers have ruined it for the people who actually need it.