REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD., LEROY BAYLOR, WALTER L. SMITH BA., ADRIENNE EDMUNDSON, WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
Presentation to an FDA Workshop on Morphine Milligram Equivalents July 16, 2021
FROM THE LAWHERN FILES:
STORY BY DONNA CORLEY
“When the 2016 CDC guidelines were implemented, not one part of it was considered for patients who suffered with rare disease or who have metabolic issues such as being a poor or rapid metabolizer of opioid medication with regard to the MME dosage restriction.”
Adhesive Arachnoiditis and Tarlov Cyst Disease
My name is Donna Corley and I am the Director of ASAP – Arachnoiditis Society for Awareness and Prevention.
Many thanks to the FDA panel for allowing me to speak on behalf of millions of patients living with rare, debilitating diseases such as Adhesive Arachnoiditis and Tarlov Cyst Disease, EDS, and CRPS to name a few.
When the 2016 CDC guidelines were implemented, not one part of it was considered for patients who suffered with rare disease or who have metabolic issues such as being a poor or rapid metabolizer of opioid medication with regard to the MME dosage restriction. This issue was brought to the CDCs attention many times by myself and many others, to no avail.
CDC GUIDELINES FAILED TO PATIENTS WITH RARE DISEASES
As an advocate, I always believed there was equality for everyone regardless of race, sex, religion, or even social status. Sadly, this has not been the case for those of us who suffer with these intractable pain diseases. In fact, we have received just the opposite and been ostracized, stigmatized, traumatized and left by the wayside without care of any kind by physicians who were too afraid of state & federal regulators to offer or continue treatment that many patients had been receiving successfully prior to the implementation of the CDC Guideline.
What has happened to pain patients since 2016 has been nothing short of tragic with:
- Forced tapering of their medications
- Forced withdrawals
- The loss of their stable medications
- The loss of their physicians
- The loss of their jobs and livelihoods causing many to seek disability and Medicaid
Uncontrolled pain causing many to seek suicide as the only viable solution left to them to end their tortuous agony.
All of this [was] due to MME dosage thresholds based on faulty science, lacking any sound consensus among numerous experts including the CDC authors themselves and the entire American Medical Association who stated,
CDC GUIDELINES CAUSING SUICIDES
“It is clear that the [2016] CDC Guideline has harmed many patients — so much so that in 2019, the CDC authors and HHS issued long-overdue … clarifications that states should not use the CDC Guideline to implement an arbitrary threshold.”
The AMA went on to state in their recommendations for revisions to the CDC,
“Yet, the truth of the matter is that MME thresholds remain as hard policy by many health insurers, pharmacy chains, and PBMs. The AMA strongly urges CDC to add language to the revised CDC Guideline urging those entities to rescind these policies given the absence of data to suggest a relationship between the arbitrary thresholds and improved patient outcomes—as well as the harms done to patients as a result of inappropriate tapering or denials of care.”
I had to give up a job and career I loved due to chronic pain and had to find a new purpose. That was a very hard part of my life. First, it was hard accepting that I could no longer work, and then it was hard accepting that I would be in pain for the rest of my life.
I thought it was a death sentence when I was first diagnosed with AA. Then I realized, “Hey, I’ve had it for 23 years and I’m not dead yet.” Being a quitter isn’t in my DNA, and I love my family too much to quit. I did a lot of praying, asking God, “Why me?” It was like he said to me, “I need you here.”
That’s truly when I began to have a passion, a drive to fight for awareness, to help other patients get a timely diagnosis and find new doctors. Praise God, we have quite a few great ones, but we need more.
No one should be made to feel like they are crazy, ignorant, insignificant or lying because they are in pain. I’m still here trying to love the life God has blessed me with. Yes, I see my life as a blessing. If I had not been diagnosed with these diseases, I wouldn’t know how to empathize with others in pain.
We as patients should be able to discuss our fears and concerns with our physicians and families without fear of negative consequences. It is past time people quit condemning those of us who suffer in pain because of the way we feel. (1)
STOP THE DEVASTATION DO THE RIGHT THING
You have an opportunity to undo the massive harms to millions of pain patients all across the country. On behalf of all those who couldn’t be here to speak for themselves today, we are begging you to do the right thing and stop this devastation.
Thank you for your consideration and your time.
FOR NOW, YOU ARE
WITHIN THE NORMS
ENDNOTES
