Opioid Labeling Changes Petition

[101N]

Physicians for responsible opioid prescribing is petitioning the FDA for opioid labeling changes...

http://www.citizen.org/documents/2048.pdf

Dear Friends and Colleagues,

I’m writing in the hope that you’ll submit comments to FDA supporting the citizen petition for label changes on opioid analgesics.

Here’s the link where you can submit comments: http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001

As you may have heard, a couple of weeks ago PROP filed this petition with FDA. This request has received support from members of Congress, including Rep. Mary Bono Mack and Hal Rogers, so we believe that FDA is paying close attention.

You can read the petition here: http://www.citizen.org/documents/2048.pdf And here’s a press release about the petition that was issued by Public Citizen: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3674

If FDA implements our request, opioid manufacturers will be prohibited from promoting long-term use of opioids for chronic non-cancer pain and the medical community will be informed that this practice has not been proven safe and effective. We believe that this will help reduce overprescribing of opioids. And since it’s overprescribing that’s harming pain patients and fueling the opioid addiction epidemic, the label change could help bring this public health crisis under control.

FDA just started receiving comments from the public about the petition. It takes just a couple of minutes to submit comments. And just a few sentences are fine. Just make sure to state clearly in the first or second sentence that you support the petition. If you want, you’re able to upload attachments, including medical articles, newspaper stories or anything that might help you get your point across.

FDA will periodically post comments that are submitted. So far, comments opposing the petition outnumber comments supporting the petition… so PLEASE submit your comments and please ask others to submit comments too.

Thank you for considering this request.

-Andrew

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[Aether2000]

This petition is based on paranoia and on ineptitude of physicians to control their own patient populations. It has little basis in fact and would ultimately achieve their goal of wiping out an effective treatment regimen for millions of Americans and absolve them of their eschewed responsibility to monitor their patients appropriately.

 

[101N]

http://www.painmed.org/files/aapm-response-to-prop-petition.pdf

 

[101N]

http://www.citizen.org/documents/2048.pdf

 

[drusso]

Things are about to get interesting...

 

[facets]

+1 it's a sad day when the elderly with crippling pain can't get medication because of the abuse of a few

This petition is based on paranoia and on ineptitude of physicians to control their own patient populations. It has little basis in fact and would ultimately achieve their goal of wiping out an effective treatment regimen for millions of Americans and absolve them of their eschewed responsibility to monitor their patients appropriately.

 

[101N]

+1 it's a sad day when the elderly with crippling pain can't get medication because of the abuse of a few

It's a sad day when:

1. The most prescribed drug in the US is hydrocodone.
2. The rate of narcotic overdose deaths in the US exceeds MVA deaths
3. 20% of US teens use prescription opioids to get high
4. Prominent physicians who advocate for the liberal use of opioids are paid by drug companies to do so.
5. When an opioid overuse epidemic is not only ignored by, but denied by 'pain specialists'.
6. and so on, and so forth, ad infinitum

 

[lobelsteve]

61 y/o male with FBSS and epidural fibrosis. Works a heavy labor occupation 40 hrs per week. Has 2 years of work left until he is fully vested in his 401k and can retire without severe penalty. Takes Lyrica 150mg bid, Cymbalta 60mg bid, Oxycodone 30mg q6h, Zanaflex 8mg for sleep. SCS is dual octrode array at T8, helping back and leg pain. If any one of his meds were taken away, he could not work full time outside of sedentary and that is not available. If SCS is turned off, he could not work full time. He marks off on his calendar the days he has left.

No aberrant behaviors, no side effects from medication.

 

[deleted185747]

The patient Steve describes ought to be able to continue his treatment plan.

However:

What if only board certified pain doctors were eligible to Rx COMT? They would have to be well paid to do that type of work (which would involve turning some patients away and referring some to addiction medicine) which could lead to the slippery slope of becoming a pill mill.

 

[Ducttape]

61 y/o male with FBSS and epidural fibrosis. Works a heavy labor occupation 40 hrs per week. Has 2 years of work left until he is fully vested in his 401k and can retire without severe penalty. Takes Lyrica 150mg bid, Cymbalta 60mg bid, Oxycodone 30mg q6h, Zanaflex 8mg for sleep. SCS is dual octrode array at T8, helping back and leg pain. If any one of his meds were taken away, he could not work full time outside of sedentary and that is not available. If SCS is turned off, he could not work full time. He marks off on his calendar the days he has left.

No aberrant behaviors, no side effects from medication.

the problem is, one can make a valid argument that, after the appropriate period of time after being tapered off of his 120 mg of oxycodone a day, that he may notice no worsening in pain, and possibly improvement in certain parameters, such as functionality, energy (due possibly to low T), and outlook on life.

i have an N of about 30 now of patients on 120 MED or greater, and with 1 exception, all of them are vastly improved after undergoing a taper. One of them has had an SCS (AFTER the taper), lost 30 pounds, started doing volunteer work (on SSD), and is an SCS ambassador. Another on 200 mcg/hr fentanyl and SQ morphine infusion (15 mg/hr) notes absolutely on difference in his pain, but feels better able to tolerate his ADLs, and has gone back to driving.

 

[Aether2000]

True....that is also the case with some of my patients and weaning is also with a try. But universal application of this is not possible. It is also true that I have more than 20 patients in whom I have removed inappropriately placed spinal spinal cord stims and many others rescued from unethical doctors that did 30-50 interventional injections in a year resulting in over 100 lbs weight gain in one year. Point is- interventional pain is not innocuous and does result in death. But unlike opioids when death is linked temporally the deaths and injury from interventional procedures are not readily identified. So there are problems with both interventional procedures and opioids. We need both in our fight against chronic pain...both are potentially lethal.

 

[Jcm800]

It's a sad day when:

1. The most prescribed drug in the US is hydrocodone.
2. The rate of narcotic overdose deaths in the US exceeds MVA deaths
3. 20% of US teens use prescription opioids to get high
4. Prominent physicians who advocate for the liberal use of opioids are paid by drug companies to do so.
5. When an opioid overuse epidemic is not only ignored by, but denied by 'pain specialists'.
6. and so on, and so forth, ad infinitum

To be honest, point #6 is not really a point

 

[lobelsteve]

It's a sad day when:

1. The most prescribed drug in the US is hydrocodone.

It is not my most prescribed drug, and I bet not on the top 3 for most of us.

2. The rate of narcotic overdose deaths in the US exceeds MVA deaths

A function of prescribing by poorly trained PCP's and pill mills coupled with a significant reduction in MVA deaths due to change in auto safety and DUI enforcement.

3. 20% of US teens use prescription opioids to get high

Nothing to do with pain physicians. I have not Rx'd an opiate to a teenager in my career, and I have seen 3 teens in 8 years.

4. Prominent physicians who advocate for the liberal use of opioids are paid by drug companies to do so.

Caveat emptor. But this needs to stop as the advice given by Portenoy et al was poor, damaging, and allowed the pendulum to swing too far.

5. When an opioid overuse epidemic is not only ignored by, but denied by 'pain specialists'.

I'm sure we all only prescribe when we think it is appropriate. And only after a rigorous assessment including full due diligence. I'm certain this is not the case with non-pain trained docs.

6. and so on, and so forth, ad infinitum

If the hammer falls on opiates, there will be a lot of low to moderate risk patients become "addicts" because legitimate medical care would have been denied. It is then easy to say it is not our problem any longer, but it does a significant more amount of harm then good.

 

[Ducttape]

the general consensus is that the opioid "problem" is not our problem, that we all prescribe appropriately. it is the PCP or pill mill that is the primary problem, right?

the problem with this supposition is that it attempts to deflect blame from pain physicians and does nothing to address the root problem. What does a PCP do when a patient says or begs for opioid medication for their severe pain? "Ive tried everything, only Vico-Perco-done works. i want to keep coming here, and not give bad Press-Gainey Scores. what can i do (wink wink)?"

Education and helping PCPs, dentists, etc. develop a backbone is an important step. but there are those out there that keep espousing chronic opioid therapy.

so the only way i can envision any improvement in the opioid problem out there is to impose some limits, either with who can prescribe or the dose limitations.

 

[Aether2000]

There is very little evidence to support the notion that opioids are not effective for chronic pain. There is insufficient evidence of high quality to support the notion that opioids are effective for chronic pain. In the situation where scientific evidence is lacking, the clinical skills of the physician become most important, and there are many with the common sense with which to use opioids effectively. It is the PCPs that are resulting in the most deaths in chronic pain (source: Indiana Health Dept). Therefore, changing the behavior of the prescribing physician becomes of paramount importance. Since there are insufficient pain physicians willing to prescribe opioids, it is absurd to require referral to a pain physician. Since PCPs may prescribe very high dose opioids to 10% of their population and very low or none to the remainder, it is absurd to elect an arbitrary 50% of patients receiving opioids to require registration as a pain clinic. Since there is no science behind arbitrary mg dosage cutoffs (studies are observational and do not account for what was taken, only what was prescribed within their non-closed system), it is absurd to embark on rationing based on arbitrary limits.
The appropriate way to engage physicians is a carrot and stick approach that provides them with much needed information that is currently lacking (hospital admissions, coroner data, PMP mandatory, UDS mandatory) and then give the physicians expectations on monitoring and reduction of opioids when indicated. Then if they don't, whack them with a stick. At this point in time, the expectations are so poorly defined and nebulous by most states, it is impossible for the physician to understand whether he is operating within the medical board expectations or state laws.

 

[Ducttape]

some are obviously now arguing that this approach is the one that has been used, unsuccessfully, and that is why something has to be done.

if physicians are unwilling to allow other physicians to police them, which is currently the case, then government must take over, according to them. and that is because of the conflicting information that "pain specialists" have provided with PCPs. in a way, their reasoning is hard to argue with.

 

[101N]

that is because of the conflicting information that "pain specialists" have provided with PCPs. in a way, their reasoning is hard to argue with.

1+

Not only do the thought leaders in our field receive honeraria from PHARMA, many of them also receive legal fees for explicitly condoning the behavior some of the most notorius over-prescribers of opioids. Ergo, suggesting that organized pain medicine isn't in part responsible for the current epidemic is nonsense. On this issue there has been a failure of leadership, hence the congressional investigation of our leadership.

http://www.nytimes.com/2007/03/27/science/27tier.html?_r=1&scp=2&sq=Russell+Portenoy&st=nyt

"During the first trial, the prosecution argued that it was beyond the “bounds of medicine” for Dr. Hurwitz to prescribe more than 195 milligrams of morphine per day, but dosages more than 60 times that level are considered acceptable in a medical textbook. The prosecution’s supposedly expert testimony on dosage levels and proper pain treatment for drug addicts was called “factually wrong” and “without foundation in the medical literature” in a joint statement by Dr. Russell K. Portenoy and five other past presidents of the American Pain Society.

 

[Aether2000]

I agree physicians are incapable of policing themselves, but neither are NPs, PAs, etc. Therefore government intervention is necessary.

 

[PMR 4 MSK]

61 y/o male with FBSS and epidural fibrosis. Works a heavy labor occupation 40 hrs per week. Has 2 years of work left until he is fully vested in his 401k and can retire without severe penalty. Takes Lyrica 150mg bid, Cymbalta 60mg bid, Oxycodone 30mg q6h, Zanaflex 8mg for sleep. SCS is dual octrode array at T8, helping back and leg pain. If any one of his meds were taken away, he could not work full time outside of sedentary and that is not available. If SCS is turned off, he could not work full time. He marks off on his calendar the days he has left.

No aberrant behaviors, no side effects from medication.

You are alluding that the patient who works is more deserving of opioids than one who does not. That could be viewed as judgemental.

I would offer that this patient works only because of motivation. If that retirement package were not soooo close, would he still be working?

Will you cut him off from opioids when he retires?

 

[lobelsteve]

You are alluding that the patient who works is more deserving of opioids than one who does not. That could be viewed as judgemental.

I would offer that this patient works only because of motivation. If that retirement package were not soooo close, would he still be working?

Will you cut him off from opioids when he retires?

When he retires and I taper him, I'll le you know. It is the plan.