Event is intended to inform legislator, the healthcare industry and general public about the essential need for opioid medication as part of a chronic pain patients wellness plan. The CDC guidelines are in the process of being restated or clarified but until Arizona legislators change the harmful language in SB1001 the unintended consequences from the “Opioid Crisis” will continue. This is not a protest, civil disobedience or attack on any particular segment of the population. The 2-hour Don’t Punish Pain Rally will consist of informed speakers consisting of 10-minutes each and for the remainder of the time 3-minute open microphone for chronic pain patients who will explain how their health and quality of life has been negatively affected by theCDC guidelines.
Arizona Don’t Punish Pain Rally
May 22, 2019
10:00 AM – 12:00 PM
AZ Arizona State Capitol – House Lawn (Directly east of the State Capital building)
1700 W Washington Street
Phoenix, AZ 85007 + Google Map
Who are we – Over 100 million pain patients battling chronic diseases & conditions; veterans; post-operative, acute pain & cancer patients. Supportive medical professionals unable to treat Arizona pain patients due CDC Guideline adoption and SB1001 legislation.
Why rally – To protect health care rights for current & future chronic pain patients needing management of long-term intractable pain. To pressure government for a balanced, not lopsided, solutions. To build a national united voice for chronic pain patients unintentionally negatively affected from the “Opioid Crisis” and how it has effected legitimate pain patients.
Target audience – This rally was designed to inform everyone that proper utilization of pain medication for chronic pain patients is not addiction. We hope to inform the general public that there is a disabled segment of the pain community who have been negatively affected by the CDC Guidelines. There have been increased suicides, employment loss, degradation of patient’s quality of life because of the “mandated” reduction on opioids. The 90 mg morphine equivalent threshold have reduced pain patient’s access to proper pain relief.
What needs to be change by entities –
Recommended by: (JATH EDUCATIONAL CONSORTIUM, LLC) Erin O. LeBlanc, Thomas F. Kline, MD
- Clarification on the population descriptions studied. It appears 95% of the data is coming from addicts who overdose and die.
- Discuss the science of applying conclusions from one population base (addicts) to a different population base (medical patients receiving legitimate prescriptions in controlled amounts).
- Present follow up data on “unintended consequences” of the Guidelines as mandated by the Scientific Counsellors in their report of January 2016.
- Any and all medical education on the topic of pain medicine must come through the FDA REMS system (the Congressionally mandated agency for monitoring prescription drugs).
- Current medical education designed by CDC must be reviewed by outside Medical Education specialists to be sure the data from deaths among street addicts is not being applied to the general population (as was the case when I took a CDC Continuing Medical Education video — which due to inaccuracies I stopped and voided my CME certificate).
- Collate and publish in MMWR all CDC statements subsequent to March 15th, 2016 explaining what was actually meant by the “Guideline” intents.
- Explain FDA is the regulating agency for opiate pain medicine and practitioners may prescribe any amount opioid of any medication they deem medically necessary, watching for side effects.
- Explain the data CDC has collected on suicides listing how many were due to pain medication reductions.
- CDC needs to present the data from the FDA review of opiate prescribing limits (FDA 2012-P-0818) in which all the proposed restrictions on opiate prescribing were found unsupportable by the FDA reviews and why these findings were not honoured in the final draft of the “Guideline”.
- Explain whether CDC data indicates true opiate addiction is increasing and explain that Opioid Use Disorder is not classic opiate addiction.
- Explain the science behind the now infamous and harmful “90mg” cut-off.
- CDC needs to address the question of why the “Guideline” was designed for primary care practitioners, apparently excluding all others?
- CDC needs to explain why they regard their recommendations as of “low scientific validity” yet published them in the “Guideline” based only on the opinions of selected consultants many with histories of unusual and outside general medical practice.
- CDC needs to explain why meetings were held in secret and the plan was to publish the “Guideline” without public hearings.
- CDC needs to explain their position, as espoused by Thomas Frieden, then Director of the CDC, that “Overprescribing of opioids — largely for chronic pain- is a key driver of America’s drug overdose epidemic” is tenable given the number of prescriptions is (1) inflated by the DEA rule that three separate prescriptions must be written where other countries allow one prescription for three monthly refills and (2) the CDC already had data in their hands showing that prescriptions had been falling for 6 years prior to the “Guideline” and the deaths were accelerating — a serious inconsistency unpinning the mass forced reduction in treatment plans for 6 million painful disease patient — the pain refugees.
- The word voluntary is buried one time in the text of the “Guideline.” CDC must reinforce this and explain that voluntary implies non-binding with binding regulations coming only from the FDA where no maximal dose exists.
- Deborah Houry, MD, head of the section producing the “Guideline” said “today we know that he serious and fatal risks of opioids (for chronic pain) far outweigh the uncertain benefits.” Dr. Houry needs to explain “uncertain benefits.”
- Until proper studies, (not unethical controlled trials which would not pass muster with ethics committees, the lack of which prop up the main assumption of “uncertain benefits”) are performed such as descriptive studies by survey methods are completed no governmental medical policy should be released.
- A resumption of the House Committee on Oversight and Government Reform query into the activities of the CDC under Thomas Frieden MD, Director as to the authority for issuing medical guidelines on prescription drugs when the agency is not tasked to do so.
- Suspend all administrative raids on doctors’ offices conducted without probable cause and substitute requests for needs to auditing medical records with certified letters (as does CMS when auditing medical files).
- DEA must provide Miranda type disclosure before attempting to have the practicing physician surrender their DEA license.
- Patient records removed from the practicing physician’s office disrupts medical care and the doctor-patient relationship. Doctors are not drug cartels who would shred the documents. Copies of the records except in probably cause arrests would suffice and protect the medical care for patients who suddenly have no medical records
- CDC, FDA, and DEA need to make it clear that there are no prescribing limits of opioids and investigations on this premise will cease for legitimate office doctors in legimated medical practices. If a physician is prescribing too “too much” it is a state matter of medical practice.
- DEA needs to make it clear practitioners will not lose their livelihoods capricious.
- Set up internet communication with all licensees to make it clear what will cause DEA police actions and as important what physician activities will not lead to police investigation, raids or prosecutions.
- Set a precise legal definitions of practicing medicine for outside “legitimate purpose” that involves law not aspects of medical practice such as co-prescriptions, amounts of pills, amount of individual medicine dosage.
- Provide proof to Congress that restricting the manufacture of opiate pain medicine, 95% of which goes to the treatment of pain, does not harm the medical patients and show that the restrictions have led to a reduction in overdose deaths and addiction.
- No physician should be investigated by the federal drug policy for “prescribing too much” since there is no definition by FDA nor by legal precedent of “too much.”
- DEA and CDC need to issue a joint statement that the 90mg cut-off is for first time opiate use only and is a voluntary suggestion.
- DEA red flags originating with the Brandeis PDMP training center must be validated outside the DOJ contract.
- The principle of “should have known” to prosecute physicians for patients who sell their prescriptions is said to be based on DEA regulation 21 CFR 1301.72 to .76 needs review as it appears this does not actually apply to practicing physicians who do not have opiate dispensaries on premises, which is rare. Physicians are prosecuted for failing to do criminal investigations on their patients when the patients end up selling their prescriptions. Physicians are not law enforcement and the presumption they are would destroy the doctor patient relationship of trust. The principle of “should have known” requires the physician to detect future criminal behaviour of their patients at a 100% rate, a rate not found in law enforcement itself.
- When a physician is accused of causing a death with his or her treatment then full autopsies must be performed, not just blood tests, along with a forensic investigation plus a “psychological autopsy” to prove “beyond a reasonable doubt”. Accusing a physician of manslaughter is a serious matter. Blood tests alone are not appropriate. This full investigation would be performed to support the premise doctors needs to be proven guilty like other defendants, to rule out death from other causes. A person dying with my prescriptions on board would be expected to have blood levels of opioidsif they are following my instructions and then die from a heart attack.
- Work more closely with the addiction community with immunity for minor CSA infractions to identify sources of fentanyl.
- Physicians will not respond the new Opioid Refugee Crisis without new update information from the same sources that have caused the pain refugee crisis. (see above)
- Need to stop accusing people in pain of being doctor shoppers, addicts, and people using poor choice. This is cruel and legally risky.
- Forty-three percent of doctors in North Carolina has stopped prescribing opiate pain medicine caught up in the “I will lose my license” and “be arrested by the DEA”. Nationally the figures are the same or higher. Incentives for recapturing displaced pain patients. . We suggest a temporary CMS allowance for maximum billing codes to create a new “Certificate of Medical Pain Disease” and a “Certificate of Palliative Care Status” This would be an hour long intensive history and physical to establish and justify the need for long term medical pain medication and why. Once done this certificate can be presented to other doctors, pharmacies (where refusal to fill valid prescriptions has already lead to suicides), insurance companies, benefit managers, hospital ER’s, hospital surgical services, Medicaid, and Medicare. This would protect innocent medical patients from the harmful policies intended for addicts and put a disclaimer on the principle of “too much” unless the FDA changes the guidelines for opiate administration.
- Counter CDC education needs to be produced by FDA or NIH as CDC “educational modules” are presenting things that will influence medical practice in an unsupported and negative manner.
- Physicians and patients need to meet in moderated sessions for a “truth and reconciliation” educational forum.
- Physicians need CME activities not centered around when not to prescribe opiate pain medication but when these traditionally useful drugs should be used and tricks of the trade.
- Obtain Health and Human Services (HHS) funding for factual healthcare educational programs outside the CDC’s unsupported, self-proclaimed unscientific and heavily biased government views of pain and pain medicines attempting to change centuries of medical care for the person in pain.
- HHS might develop a compendium of the various uncommon disease with painful components might be a worthwhile expenditure of funds. Manuals for primary care practitioners teaching the tricks of opiate prescribing with case histories and inputs from other physicians, not government officials could be published.
Pharmacists need to stop public statements in front of patients and staff accusing people with pain medicine prescriptions of being doctor shoppers and addicts. Making derogatory remarks about the patient’s doctor “we are not going to fill Dr. X’s prescriptions anymore. A risky public statement unless true.
- CMS and NIH funding for factual healthcare educational programs outside the CDC/PROP teachings.
- Disband the Pharmacy Benefits Manager system and replace with the system used by Medicaid.
- Standard for pharmacist who deny prescriptions without due diligence.
- The Prescription Drug Monitoring Program (PDMP) systems need a cost and effectiveness analysis along with analysis of unintended consequences of secret “red flagging” and surveillance of practicing physicians using untested profiling parameters. The reason for the “unsolicited reports” on doctors from this pharmacy data needs to be explained.
- The PDMP appears to be a law enforcement tool and as such need to have probable cause provisions before any professional is subjected to investigation based on profiling criteria created from Brandeis University, Heller School DOJ grant money.
Public Health Recommendations:
- Begin public health education for families and high school students for early intervention into opiate addiction where 90% of them start, not by programs of abstinence but programs of facts of the difference between type 2 opiate addiction, a genetic mu receptor disease, and type 1 addictions of choice, behaviourally reinforced by not triggered by genetic variant in the brain. Although rare, 4/1000 each person snatched from the jaws of addiction can lead a normal life with this genetic disease, if compassionately and intelligently treated.
- Begin public health outreach to those with type 2 addiction disease: confidential medical and pharmacist “advice lines” without retribution; distribution of “ambu” bags and masks ($20) so with a buddy system one addict can keep another addict alive indefinitely treating their apnoea from multiple drug accidental overdoses, decriminalize paraphernalia and small possessions.
Richard JacobsonUS Pain Foundation Ambassador & Arizona Don’t Punish Pain Rally Coordinator480-822-0998Richard.Jacobson.Phoenix@gmail.com
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