- Sally Howard- chief of staff HHSPROP-Docket #FDA-2012-P-0818-00010
- Margaret HamburgFDA-HHS-PROP-Docket #FDA-2012-P-0818-00010
- Deborah McCannonFDA-HHS-PROP-Docket #FDA-2012-P-0818-00010
- Kenneth MunsonHHS Regional Director R-5
- Janet Woodcock MDFDA- HHS-PROP-Docket #FDA-2012-P-0818-00010
- Honorable Congresswoman Mary Bono MackWhite House
- Honorable Congressman Hal RogersWHITE HOUSE
- FDAPROP-Docket #FDA-2012-P-0818-00010
- Docket Management food and drug divisionFDA- HHS-PROP-Docket #FDA-2012-P-0818-00010
Please Help to stop PROP's Petition
This petition is for all of us who suffer from chronic pain ! and our right to stand our ground and Have a voice in this matter! By petitioning the FDA to save our rights to relief from the suffering and pain we experience day in and day out. Chronic pain sufferers have a voice that needs to be heard. We as chronic pain sufferers out-number these that are trying to limit our access to opioid medications. The more signatures we receive on this petition the louder our voice will be. If the FDA accepts the changes asked for by PROP it will limit our rights to receive the opioid medications we have to take to have some sort of quality of life. For chronic pain patients opioids allow us to get dressed in the morning, get out of bed, and do some activities we had prior to our onset of pain and the life changing experiences we have faced due to our chronic pain. Please not only take a few moments to sign this petition so the FDA can hear our unified voices loud and clear, but please join in our fight by sharing this petition. Together we can stop this. Together we have a voice! Together we will save lives!
- U.S. House of Representatives
- FDA-HHS-PROP-Docket #FDA-2012-P-0818-00010
- FDA-HHS-PROP-Docket #FDA-2012-P-0818-00010
- HHS Regional Director R-5
- FDA- HHS-PROP-Docket #FDA-2012-P-0818-00010
Janet Woodcock MD
- White House
Honorable Congresswoman Mary Bono Mack
- WHITE HOUSE
Honorable Congressman Hal Rogers
- PROP-Docket #FDA-2012-P-0818-00010
- FDA- HHS-PROP-Docket #FDA-2012-P-0818-00010
Docket Management food and drug division
- FDA Director, Center for Drug Evaluation & Research
Janet Woodcock, M.D.
I just signed the following petition addressed to: PHYSICIANS FOR RESPONSIBLE OPIOID PRESCRIBING.
U.S. Food and Drug Administration:
Attention: President Obama, Margaret Hamburg, Sandy Walsh, Hal Rogers, Mary Bono Mack
Subject: Support of Long Term Use of Opiods for Chronic Intractable Incurable Pain (CIIP)
We suffer, or know of someone who suffers, from Chronic Intractable Incurable Pain (CIIP). This pain condition is debilitating and disabling if patients are left untreated, or under treated. We are confronted with a lifetime of suffering that will not end until life itself ends.
We understand that a group of physicians organized as PROP (Physicians for Responsible Opioid Prescribing) sent the FDA a petition that grossly misrepresents us and our disease. PROP proposes that the FDA will required the pharmaceutical companies to change the labeling on opioids, for a limit of 100 mg per day and for no more than a 90 day supply. Any higher or longer duration prescription would require a pain clinic. The PROP letter disregards those who suffer Chronic Intractable Incurable Pain. PROP is led by Dr. Andrew Kolodny head of psychiatry at Maimonades Medical Center in Brooklyn, NY."
We believe PROP's proposals are aimed at trying to treat the problem of abuse and addiction but will have the effect of limiting access to legitimate treatment for those of us with CNCP (CIIP). We agree that the abuse of opioIds and ensuing deaths is tragic and needs to be addressed. However, we also believe that PROP's petition threatens us with the loss of one of our few options to relieve our relentless pain. We believe PROP's proposals will only worsen the years of suffering that faces those of us for whom there is no alternative treatment for pain.
In their petition, PROP states that they have considered all evidence of potential harm to others. We adamantly disagree. We, those who suffer from, or are adversely affected by such suffering, assert that PROP's petition has not considered the degree and extent of lifelong suffering endured by those have CNCP (CIIP).
We demand that our suffering and our response to opioids be reviewed and formally studied before the FDA makes any changes to the marketing rules for opioids. We believe PROP's proposals would severely limit the legitimate availability for those of us who suffer, while doing little if anything to limit the supply to those who abuse and criminally divert.
We pose the following specific objections to PROP's petition:
1. For those of us who suffer CIIP, the "90 day" limit ion marketing will, as often happens, become the standard of care for treatment of all pain. By contrast we can expect to suffer pain for up to 20,000 days or more. That fact shows how absolutely short-sided the PROP proposal is. On that score alone, they fail the Section 23.10 criteria.
2. PROP proposes that marketing, as listed on the package insert, be listed as "100 mg morphine equivalents" per day. That fails to take into account the true scientific and clinical issues that are required for the management of the very complex and poorly understood disease of CIIP. First, data on "dose equivalents" is based on very poor data. Indeed, using such published tables has probably been a major factor in the excess number of opioid deaths that occur with Methadone! Second, such cookbook approaches fail to account for individual, sometimes genetic, differences in absorption, metabolism and even transition across the blood brain barrier. We know that there are people who metabolize opiods rapidly and some slowly. We know that other medications, herbs and even foods, can alter the rate of metabolism. In this setting, PROP's proposals are not only simplistic, but serve to further endanger the health and well-being of many people. Indeed, 100 mg per day of morphine for a super slow metabolize r could well be a lethal dose. but a placebo for a super-rapid metabolize r.
3. PROP's highly coordinated "press release" demonstrates the presence of a well-funded and staffed and organized public relations program. We demand that PROP's funding sources and staffing patterns be published publicly for all to see.
4. PROP has stated that there is no evidence of the benefit of long term opioid use in chronic non-cancer pain. We agree absolutely that there is very little if any good study about any aspect of the suffering endured by CNCP (CIIP) patients. That does not mean our suffering does not exist and it does mean that opioids do play a vital role in relieving that suffering. PROP makes the sophomoric error on logic, that the absence of studies about a problem proves the absence of the problem.
5. PROP, like many who are arguing against the use opioids in CNCP (CIIP) seems to ignore the established medical history of so many of those who suffer. In most cases we have a clearly demonstrated history of responsible use over many years. And yet PROP's proposals would further heighten the growing practice of treating CHRONIC sufferers as if we are new patient's each and every time we go to the doctor. We demand that the FDA give credence to the established medical histories of those of us with CNCP (CIIP) when we have established track records for responsible opioid use.
6. In the absence of valid scientifically collected data, PROP has, like so many other agencies, jumped in with proposals as if they know what is best for us. They have usurped our right to make informed decisions about our medical care with our doctors. Their proposals do place a serious wedge between those of us who suffer, and the doctors on whom we depend, for at least some minimal relief of suffering with the added ability to participate in daily life activities.
7. There are a growing number of so called pain clinics that refuse to prescribe medications, but will perform invasive injections, of unproven long term benefit. At least in some cases, patients are now coerced with these invasive procedures as a prerequisite to receiving opioids. PROP's proposals will only serve to enhance that type of mistreatment. Long term, we fear that there will be a serious epidemic of documented arachnoiditis in people who are undergoing these treatments. opioids do not have that dreadful and irreversible chronic adverse effect.
8. PROP cites one study that implies opioids in elderly patients cause falls and fractures. There are other studies that show just the opposite. The fact that pain causes falls and impaired balance can be gleaned from listening to pain sufferers. These falls and impaired balance occur regardless of whether opioids are used or not! We demand that the FDA require high quality medical studies to fully and adequately assess the risk of falling in pain sufferers. We certainly have anecdotal reports of improved balance with use of opioids at appropriate dose in CNCP (CIIP)!
In this setting we wish to assert that the PROP petition should be rejected summarily by the FDA, and that the FDA require immediate high quality studies of the long term use of opioids in our disease. We assert that for us, the opioids are frequently analogous to the ramps that remove accessibility barriers for those with physical impairment. For those of us with interminable intractable incurable pain, opioids are in fact our ramp to at least limited participation in life's normal activities. There is inadequate access to assessment and treatment of acute and chronic pain syndromes in many parts of the world including the United States. It is the right of any human individual to have easy access to adequate pain management.
All of us who have signed this letter are suffering from an incurable chronic pain condition, arachnoiditis, and many of us were misdiagnosed with conditions that would prevent physicians from prescribing opioids on a long term basis. Some cases of arachnoiditis are a direct consequence of the current state of practice in the treatment of pain, which is to coerce patients into invasive spinal procedures (which obviously increases profits for physicians and surgery centers), rather than support responsible long term use of opioids. All signers of this letter are long term responsible users of opioids (between two and _18_ years),
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