Pain Management Community

Sorry I just realized Anon 160307 has posted a similar article from the same author. So, Anon 160...would you mind also posting links to the petition within this thread too? It would be nice to have what you suggested here too, as far as links go. Thanks!

I think people need to realize just how many "citizen petitions" are sent to the FDA every single day....

It's really not something to worry about as the FDA will not make this kind of determinination based on one small petition.

It's more important for people to follow their own state's laws/regulations on opiate prescribing and what is in the legislature right now that is going to pass. THIS is what directly effects people more quickly.

For the FDA to turn around and actually make a new recommendation takes years and years with hearings upon hearings. A citizens petition is barely a buzz in their ear.

Just look at the new FDA recommendation on acetaminophen....This has taken almost 10 years of studies, hearings, meetings, reports, etc. for them to get to that.

No, they may not make considerations of a "small petition" but they will take notice of politicians who write letters such as this: (posted in the comment section, by Dr. Levitt)

....On July 26, 2012, Congresswoman Mary Bono Mack and 5 fellow members of the Congressional Caucus on Prescription Drug Abuse sent a public letter [PDF available here> to Margaret Hamburg, MD, FDA Commissioner, essentially endorsing the Petition and all of its recommended labeling changes. The letter concludes:

"01CWe believe that if a labeling change were made to opioid analgesics to reflect the uncertainty and lack of evidence surrounding safety and effectiveness of these drugs for treatment of chronic non-cancer pain, physicians would think twice before prescribing these highly addictive narcotics for "018moderate"019 pain such as a toothache or sore knee. While those who seek treatment for cancer pain and other diseases that cause "018severe"019 pain would not be affected, the number of individuals prescribed opiate painkillers without evidence of the long-term safety and effectiveness may decrease and limit those susceptible to developing opioid dependence."01D

This letter commands that the FDA pay serious attention to this issue, since the Caucus closes with, "01Cwe request an expedited review of the Citizen Petition submitted to FDA, and look forward to a timely response."01D....

She (Mack) is obviously malinformed on the topic. But what we should be worried about is our elected officials (without MD licensure) taking on the role of parenting in this supposed "epidemic).

Overall I found the article comforting as the author disemboweled this minority fueled by unreliable research. (I hoped that readers would feel more at ease-not in such panic.)

If it gives comfort to those concerned to present their voice, then why not? But like you said, it could be equivalent to a drop in the bucket, whereas objectification on the people's level may prove to be much more effective (e.g. voting).

Thanks for sharing more...And yes...I agree that it is helpful to read the article to hopefully provide more comfort to those that are worried about the petition:)

Hi Bren Bren,

Below is a link to the site where you can submit your comment:

http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001

You will need to click on the "Comment Now" button in the right hand corner. This link is also in the article that Bren Bren posted above.

The government DOES take the comments that the citizen post regarding a petition into account. There is a link to a faq page on the website (in the far right upper hand corner) I posted above that discusses exactly how comments to the petition are used.

I have heard compliants all over the web from chronic pain patients that feel that they don't have a voice regarding the changes in treatment for chronic non cancer pain (CNCP) that are being proposed to the FDA, DEA, and through Congress.

I don't believe in complacency. I believe that we as chronic pain patients should advocate to protect our rights to treatment. I know that those against opioids for CNCP are advocating these groups looking to change the rules in a negative way.

I do believe that I have a great doctor that would continue to prescribe my meds despite a labeling change, should it occur; but I am advocating for those out there that are suffering from undertreatment of pain or non-treatment of pain. I believe we should all band together and support one another.

This small petition is part of a bigger movement against treatment for CNCP. I believe that the more the FDA, DEA, and Congress are aware of the devastating impacts to patients, the more they will have a "balanced view" on the matter versus a biased view based on the majority of comments being submitted as I type that are against treatment of CNCP. Their viewpoint could influence the many other proposed negative healthcare changes out there related to opioid prescribing that may be more hindering to us all in the near future as there is a lot we don't know about yet that is happening in Washington D.C. to address the "epidemic" of prescription drug abuse in America.

The above is just an expression of my opinions/beliefs on the matter and is in no way meant to pressure the CNCP community to act before it is too late.

I wasn't saying that our comments don't count. And yes, I realize there is a place for comments to the petitions...

I was saying that the citizens petition to the FDA about wanting to change opiate prescribing is not likely to make a single dent.

That the FDA will not just automatically change their recommendations based on this one citizens petition made up by a few Drs...most of whom specialize in addiction.

So by all means, everyone can go and post their thoughts against the petition.

As I said, right now, the biggest threat is in each person's state. You need to know exactly who your representatives and Senators are and where they stand on pain management and opiate prescribing. State laws/regulations are changing every day which effect all of us. Your local reps are the ones where you want to make the loudest noise and are more apt to listen because as Bren and I mentioned....they need our votes:)

Hi bren-bren
Please send me the address again to you site,I forgot to write it down and now I can't find my original post!
Thanks alot,77grace
I think its a great help to alot of people!

After reading the above referenced article I went to change.org and looked up Health then search for the topic Please Help To Stop Prop's Petition by Rebecca Roberts and I signed the petition. As a long time chronic pain suffer I wanted to help and while this is not much, everything helps.

Hi Grace, Is this the one you had in mind?

http://exchanges.webmd.com/pain-management-support-group

It's actually just an exchange I created here on WebMD. Take care, B

Thanx for picking up on this issue! PROP is a group of doctors and public health officials put together by Mary Bono Mack. This congressional sub committee had a formal meeting with the head of FDA and asked them to fast track this petition. Under FDA rules, the petition having the required number of signatures is granted a impact study. Also just thought I would point out that Dr. Andrew Kolodny, President of PROP also made a large donation to Mary Bono this past April. I am the Chairman of the Board for AVA ( Advocacy for Victims of Arachnoiditis), The foundation that Started the Petition against PROP, written by Rebecca Roberts. Because it is also a citizen petition with the required number of signatures, FDA also has to do an impact study. But the whole point behind our petition is to give us as Pain Patients a strong and loud voice in matters concerning our health care. As soon as we reach our desired number of signatures, we will file our petition with Regulations.gov. Please help us and all of our Brothers and Sisters in Pain and sign and share our petition. If Anyone would like more information please contact me at wdavis70@gmail.com. Thank You for all the support!
Walt