An Open Letter to the Commissioner of US FDA
Richard Lawhern
Subject Matter Expert in public policy for regulation of opioid pain relievers and physicians who prescribe them. 28 years experience and thousands of contacts in social media support groups for people in pain.
Dear Dr. Califf
???? Commissioner, US Food and Drug Administration
????? and senior staff,
I write on behalf of the National Campaign to Protect People in Pain, to suggest that the entirety of US public health policy on treatment of severe pain with opioid analgesics is presently founded upon nothing more than myths and misinformation.??
Patients are being deserted by their doctors, who fear unjustifiable persecution by the US DEA, Federal prosecutors, or their own State Boards.?? The formerly secret injunctive provisions of the National Opioid Settlement have put in place a draconian labyrinth of "thresholds" that are creating artificial shortages at pharmacy points of delivery, even for legitimate prescriptions rendered under prevailing FDA standards. Patients are dying.? And this debacle is YOUR fault (among other officials)!
On July 23rd of this year, several of us conducted a listening session with Marta Solokowsky Ph.D., Deputy Center Director for Substance Use and Behavioral Health in the FDA's Center for Drug Evaluation and Research (CDER).? In the 90 days since that session, CDER has done absolutely nothing that we can detect to respond to the major concerns we expressed.? You can read a summary of the session in ten minutes at https://www.acsh.org/news/2024/07/30/finally-someone-listening-people-pain-48900.? This material was also shared with Dr Hobin, Chief of Staff under Dr Nora Volkow at NIDA on October 9th.
Now it is time for you to provide definitive direction to your own organization and to reach out to directors and senior staff at DHHS/OIG, CDC, the Agency for Healthcare Research and Quality, National Academies of Medicine HEAL Initiative, and the Office for National Drug Control Policy in the Executive Office of the President.??
An immediate 90-day National Review of the 2022 CDC opioid prescribing guidelines and the derivative Veterans Administration guidelines is urgently needed.? Objective of this review must be evaluation of the malfeasance and misinformation published by CDC and the consequent damage to patients and their medical providers from the CDC guidelines.? This review must be prominently supported by knowledgeable patients, caregivers, and clinicians in public meetings with proceedings published.
Failing this initiative, your Agency will become nonrelevant to American healthcare.
You can no longer dither or delay or hope that the public will go quietly and cease causing you heartburn.? This letter will be published today to social media groups potentially read by up to two million healthcare industry contributors:? doctors, nurses, pharmacists, and mental health change agents.? You and others on CC distribution may hear from other people whose lives are being damaged by your silence.?
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WE ARE A NATION IN PAIN AND WE WILL NOT BE SILENCED!
Get moving, Dr Califf.? TODAY
Richard A Lawhern Ph.D.
? Speakers Panel of the Campaign to Protect People In Pain
Email [email protected]
Facebook - https://www.facebook.com/red.lawhern/
Twitter:? @Lawhern1
Personal Website https://www.lawhern.org
CSO of MaaS Health Systems LLC dba MaaS Nanofilms and Trillium Ferroics
4 周Richard, the letter is remeniscent of General Le May's promise to accompany a B-17 group into combat and courts-martial the officers and crew of any aircraft in the group that returned to East Anglia with a full bomb load, claiming mechanical problems. It's not within FDA's powers to make state laws governing opioid dispensing nor to participate in decisions by states to set secret quotas as part of public nuisance litigation those states brought against low-profit generic drug producers. It IS up to FDA to test new pharma drugs that supposedly treat pain without using opioids. Since FDAs budget derives from user fees paid by pharma firms who seek approval of new drugs, this makes it worth asking whether FDA has vigorously combatted deceptive and false information put out by pharma firms making these allegedly-helpful new drugs. At the very least, FDA needs to release correspondence it has had with companies claiming to have invented an opioid substitute, and to disclose whether that misinformation was shared with states engaging in opioid litigation. The FDA cannot both be a regulatory body that protects the public, and a co-conspirator working for the unjust enrichment of companies pushing dangerous patent drugs.
Clinical Pharmacist
1 个月Strong Work & Thank you! Never Stop Pushing!