DOMPERIDONE: AN APPEAL FOR COMPASSION

On December 11, 2024, the FDA announced the cessation of the Expanded Access Program for Domperidone. In the wake of this decision, I would like to share a few comments from community members (who shall remain anonymous) about the impact of this decision on their health.

From my own experience, I can tell you that this medication was truly life-saving. I would not be here today without it. After diagnosis, I was so weak I could not lift my head off my pillow, could not manage even sips of liquid, and believed with all my heart I would die. All of that changed within days of starting Domperidone.

Make no mistake, there are no good alternatives for Gastroparesis patients who have likely already tried and been failed by other medications and treatments and who have relied on Domperidone to keep them alive and functioning. In many cases, Domperidone is a drug of last resort. This program is the difference between survival and starvation for many people in this community; needless suffering and deaths will result from this program's end.

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COMMUNITY REACTIONS, CONCERNS, AND EXPERIENCES

~ This was the only medication that worked to make my symptoms manageable. I am so upset! I'm only 23, was diagnosed at 21. Just feeling hopeless. I don't want to go back to the severe symptoms I had before having access to this medication.

~ I’ve been on it for 10 years, and without it, I can’t eat at all. It’s so scary, and we are helpless. Other countries make it, but it’s illegal for us to get it that way. I pray this changes

~ It was a game-changer for me. I’ve been on it for a few years, and I was in really bad shape before going on it. I am kind of freaking out.

~ Dreading the day. It helped me so much that I didn't need my feeding tube anymore.

~ They just don't care. The benefits of taking it far outweigh the cons. What about all of us who are living a better life with it? Don't we have a right to try?

~ Thanks to Domperidone, I am able to keep down small amounts of food and liquid. I implore you to seek legal avenues for patients like myself to continue accessing domperidone - whether through a new designated pharmacy, compounding pharmacies, or even ordering it from other countries.

~ I had the G-POEM in June, and they weaned me off Domperidone. That lasted a whole week before they put me back on it - worst week of my life! It was like I went back to square one, but worse! I cannot go without Domperidone or my life will change drastically! I won't have a life at all. Please, It's just awful without it!

~ This has been the only medication that has helped. I was told prior to starting it that if it failed, they would have to resort to surgical options. I truly hope this is figured out so those of us who have benefited don't have our treatments interrupted.

~ I cannot believe this! That’s like flat-out saying, “We, the FDA, do not care about Gastroparesis patients.”

~ Oh my God, I cannot go without Domperidone.

~ Omg, this is not good. It’s the only thing I can take that works.

~ Praying this doesn’t happen.

~ My 47-year-old disabled daughter, who has had very negative reactions to alternative medications, has taken Domperidone for 24 years. I just want her to live.

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POSSIBLE ALTERNATIVE TREATMENTS

Reglan/Gimoti is the only FDA-approved prokinetic for Gastroparesis. The following links provide additional information and perhaps a few treatments to be considered:

https://my.clevelandclinic.org/health/articles/prokinetic-agents

https://pmc.ncbi.nlm.nih.gov/articles/PMC8421525/

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We urge the FDA to find alternative sources, and short of that, we seek congressional intervention. The FDA and all of our policymakers must recognize the deeply negative impact the cessation of the Expanded Access Program for Domperidone will have on the gastroparesis community.

Crisis: Cessation of the FDA Expanded Access Program for Domperidone

On December 11, 2024, the FDA announced the following on its domperidone page: 

“Update: FDA was informed in late 2022 that the current supplier of domperidone was exiting the business due to transfer of ownership of the product to another company and, as such, will no longer supply domperidone tablets for treatment use under expanded access.  Efforts made in the interim to identify an alternative source have been unsuccessful. The current supply will be exhausted as early as the first or second quarter of 2025, at which time this program will no longer be able to supply domperidone for treatment use under your expanded access IND. FDA understands that this may pose challenges as you continue to care for your patient(s). We are making you aware of this development now so that you may begin to explore other treatment strategies.”

As a gastroparesis patient and advocate who has used and benefitted from the effects of domperidone for many years and has witnessed the advantages of this medication in the numerous online support groups I manage, this is alarming news.  I seek clarification and answers for my community.  

I initially contacted the FDA on December 13, 2024, to try to gain a better understanding of the situation and was denied additional information.  FDA staff, though congenial, would not specify whether the “supplier” in question was Dougherty’s Pharmacy (the only legal distributor of domperidone in the U.S. or Janssen, the manufacturer) and would not provide information as to the steps they had taken to “identify” an “alternative source.”  FDA staff indicated that the statement on the website would be the only information released to the public.  I expressed my deep concerns about the impact this would have on the gastroparesis community – as domperidone is a life-saving medication for some community members – and the narrow dissemination of the notice, as patients rarely, if ever, visit the FDA domperidone page. The FDA representative directed me to “spread the word” and consider contacting my congressional representatives (which I will gladly do). 

Upon the denial of additional details from the FDA, I contacted Dougherty’s Pharmacy directly and was informed by the pharmacy manager that they were unaware of the cessation of the FDA Expanded Access Program for domperidone.  The manager consulted the FDA website for confirmation while I was speaking with him and seemed stunned by the notice.  He instructed that he would speak with his contact at the FDA and call me back with any new information he was at liberty to share.  He contacted me the following day, after speaking with the FDA, and told me that the program seemed to be ending but he did not know the details.  He further stated that Dougherty’s was willing to continue to supply domperidone and would even compound the medication if permitted by the FDA because of domperidone’s life-saving importance to gastroparesis patients. 

After speaking with the pharmacy manager the second time, I contacted the medical science department at Janssen and spoke with a representative who, though not familiar with Motilium/domperidone, researched the product status in the system and noted that the current status of domperidone had not changed; the system indicated that Janssen was still manufacturing and providing domperidone to the FDA Expanded Access Program and there was no indication in the system that this would cease. 

Since the answers I received from Dougherty’s and Janssen did not make sense in the light of the FDA notice, I contacted the FDA again on January 7, 2025.  Again, I was denied details and was told that the program would end.  The Patient Affairs representative I spoke with wished to be helpful but did not have adequate information to supply.  She offered to research the issue and contact me once she had done so.  She contacted me the following day but could tell me no more than the update on the FDA site was the correct and only information that the public would currently be supplied.  She further encouraged me to detail the issues in a follow-up message to the FDA. 

I seek answers to the following questions:

 · Who is the “supplier” mentioned in the FDA update?  Is this Dougherty’s, Janssen, or a third party of which I am unaware?

· If Dougherty’s or Janssen is the “supplier” mentioned, why was neither party aware of the cessation of the program?

· Since the FDA has known about the supply issues since 2022, why is the gastroparesis community only now, more than 2 years later, being informed of the crisis?  Does the FDA consider this adequate notice for doctors and patients who will struggle to identify new treatment strategies?  What additional steps have been/will be taken to inform doctors and patients of the program cessation?

· What steps have been taken since 2022 to identify an alternate supplier?  Who has already been contacted and who is on the list of future contacts?  Why are there no other alternatives for obtaining domperidone if another supplier cannot be identified?

· What “other treatment strategies” does the FDA deem available to the gastroparesis community since only one medication (Reglan/Gimoti) has been approved by the FDA for use in gastroparesis patients (and that medication comes with a black box warning)?  (It should be noted as well that most patients prescribed domperidone have already tried and been failed by Metoclopramide.) 

The FDA must recognize the deeply negative impact the cessation of the Expanded Access Program for domperidone will have on the gastroparesis community.  Make no mistake, this program is the difference between survival and starvation for many people in this community; needless suffering and deaths will result.  I seek information and solutions on behalf of my community members and will not rest until I have them.  

LEARNING TO COPE

It is the helplessness that stings,
Feeling you can’t change a thing,

Watching your friends suffer and die,
While doctors and researchers stand idly by.

“It’ll get better…” but sometimes it won’t;
Often, we must simply learn how to cope.

Cope?  That’s a ruse, a trick, a cruel joke,
A deception, a distraction, an ill-conceived hoax.

The best we can do is survive another day,
Keep the darkness in check and death at bay.

They have no real answers, and so they proclaim,
“It’s all in their heads.  The patient’s to blame!”

They turn a blind eye to our struggle and pain,
Our protests ignored, our petitions made in vain.

They won’t lift a finger – perhaps they don’t care –
That our symptoms become harder and harder to bear.

No swift interventions, for we are “too complex.”
Best to pass us along, though we strongly object.

Above their pay grade; we must find someone else,
But our options are few and good ones far less.

Where are we to go and what are we to do,
When the “best in the business” haven’t a clue?

We languish and decline, left to ourselves,
Inadequate treatment – why is there no help?

We are here, and you see us; we’re aware that you do,
So, why turn your backs, when you know what we go through?

It is easy to get bitter and want to give up the fight,
When no one acknowledges or cares about our plight.

We are tired and discouraged, in need of relief,
Ill-equipped to lead the battle, worn down and weak.

Want to throw up our hands, but we can’t take a knee,
Can’t shield our hearts from the anguish we see,

Our people are in bondage, locked in a cell,
No solutions, little hope, lost and unwell.

We cannot falter or stay silent and meek,
Must press ever onward for the changes we seek.

So, we’ll steel our bodies, wasted and frail,
For the uphill battle and the rocky trails,

Spent and lacking, but determined to persist,
We’ll raise our voices and shake our fists.

That my friends, is learning to cope,
When your world burns around you and you hang onto your rope.

Though dismissed and abandoned, we are fierce and defiant,  
And they will never break us or extinguish our fire.

FROM THE OUTSIDE LOOKING IN

To you on the outside looking in,
Whose baseless judgment knows no end,
Who pretend to know enough to comprehend
Our pain and suffering, the depths to which we’ve been,
 
You who shake your heads at our great disgrace,
You with lashing tongues that diminish and abase,
From your lofty, healthy, pristine place,
Spout venom dressed up in trite cliches.
 
“A thing to behold, a blessing in disguise,”
So preach the saintly, the philosophers, and the wise,
As if our cruel illness could have an upside,
As if we’ve been granted some “soul-perfecting” prize.
 
You wield your “positivity” as if it’s a club,
“Chin up! Don’t you know you must overcome?”
No compassion, no mercy, no warmth, and no love,
Bludgeon my poor spirit till it grows cold and numb.
 
But when you’re the one who is trapped deep inside,
Inhabiting the world of the forgotten and cast aside,
Where from your brutal fate there is nowhere to hide,
Where your agony and misery cannot be denied,
 
The view appears somewhat different to you,
Murkier, muddier, and harder to see through,
Not the land of the living the others cling to,
The luscious world of wonder that you once knew.
 
We reach for a hand that might lift us up,
For an extended invitation to the joyous world above,
But rather than sweet grace, you offer only rebuff,
No matter our efforts, we are never good enough.
 
Ms. Sunshine, Mr. Righteous, I implore you to see
That your patronizing speeches and harsh enquiries
Serve only to punish, belittle, and demean;
They do nothing to cheer, inspire, or set free.
 
For we live in darkness, and every day is a chore,
Our spirits are dampened, and our bodies are at war.
We can’t readily accomplish what we were able to before,
Takes more time and great effort to replenish and restore.
 
What you see as simple and command that we do,
Is much harder for us, though we try to push through.
We are weak and depleted, gone the strength we once knew,
And every day as we waken, we start the battle anew,
 
We fight to move forward through tribulations and trials,
As survival consumes us and our lives pass us by,
We search to find meaning, know our lives are worthwhile,
It’s not as easy as it sounds to greet this all with a smile.
 
We daily face hardships you will never understand,
And must live within the limits our illnesses demand,
So, your calls to “greatness” and “helpful” reprimands,
Mean little, as we’re already doing the best that we can.
 
If you truly wish to help us, then bend down on your knees,
Pray for our healing, our comfort, our relief,
Acknowledge our struggles and offer blessings and peace,
Live among us, walk beside us, see our hearts, share our grief.
 
The barrier between us that wounds and divides,
Must fall away, and you must come inside.
Come down from the mountain, set your judgments aside,
Lovingly embrace us and try to see us through our eyes.
 
Your wagging tongues you must silence and control,
For you are called to comfort and not just to scold.
Inside, we need understanding and warm hands to hold,
Gentle spirits that nurture, loving arms that enfold.

"Coping" with the Pain

This morning, I was thinking about (and fuming over) an article I read a few years ago in which a physician commented that we are a society lacking coping skills, a people seeking "quick fixes" for our pain, one that needs to acknowledge that "suffering is part of life." He was lamenting the fact that patients came to him seeking pain-relieving medications (opioids, to be precise). His tone was mocking, condescending, and completely void of empathy or compassion, and I immediately thought to myself, "I wonder how he would feel if he lived with Gastroparesis for a spell?"

Now, I would wish this illness on no one, of course, but I am guessing the good doctor has never experienced the sort of chronic pain that I and so many in our Gastroparesis community daily endure. Perhaps I should grace him with the details...

My pain is overwhelming, send-me-to-my-knees, curl-up-in-a-ball, beg-for-mercy suffering for which no level of coping skills can prepare one. It is daily, ever-present, a physical and mental torture that confines me to my home, tethers me to a heating pad, stains my cheeks with tears, and transforms me into a raging, agonized beast who would give almost anything to rid herself of it.

It impedes sleep, and when (if) rest finally comes, it awakens me again in the nighttime. It haunts and taunts me with the knowledge that no matter how well I battled it today, it will be back again the next morning for another round -- perhaps stronger than the day before. Mentally, emotionally, and physically, it alters my being, changes who I am, and wears on me until I believe I can bear no more. And, yet, I must. I have no choice. It comes. I cannot will it away, wish it away, or pray it away. At best, I can lessen it to the point where I can function in some minimal fashion, but it will not be ignored nor placed on a back-burner. And it does not end. Ever.

So I take issue, O Wise Healer, with your suggestion that I have no coping skills and seek, instead, a "quick fix" to all of life's problems. Suffering is, indeed, a part of life, but I would wager that my suffering and that of many in my GP and chronic pain communities is nothing akin to what you have experienced. And after more than nine years of this torturous life, I am well aware there is no simple solution, no easy, consequence-free choice. But would a moment of relief, one serene, carefree, beautiful, blissful moment free from this pain be too much to ask, to expect? You hold the power to provide that, and yet you chastise us for desiring it.

I should probably clarify that I do not now, nor have I ever, used opioids. That's right, I have chosen to endure the "discomfort," as the article's author so blithely labels my suffering. But I do not make this choice lightly, and there are many days I yearn to take a different path. Many in my community do take that road. They turn to opioids (or other pain medications) because, without them, there simply is no quality of life. They cannot function in the most basic ways. They desire some small measure of comfort in a world of chronic illness where there is little.

Good Doctor, you think yourself so wise and strong because you have been blessed with a nearly pain-free, healthy existence. But take a moment to consider the "lessers" before you pass your profound judgment upon us, and, perhaps, view us from an alternate perspective -- one of compassion and empathy, free from judgment and assumptions about our motives and our abilities to "cope." We know a struggle few will ever experience.

Should we not have a voice in our care, in the path we walk? Patients are disregarded, ignored, imprisoned by pain, devoid of options... and this is unforgivable.

No, Good Doctor, I do not need any further instruction on how to endure pain. I am a trooper, a master of "overcoming," who is quite capable of "coping with" and "managing" pain; I am simply tired of having to do it! I want relief, an end to this madness. I want a cure.

Why is that so difficult to understand?

NORMAL

What is normal?
Yours or mine?
Crossed the boundary,
Never saw the warning sign.

To a world of madness,
That fluid fine line,
Now etched in permanence,
No exit to find.

Seizes your indulgences,
And all you hold dear,
From dawn into night,
Fraught with anger and fear.

Dreams and ambitions?
You won’t find them here.
Just crushing, dull numbness,
Behind the decorative veneer.

“New normal” they declare,
As if that’s something to behold,
But the memories, the good times…
I prefer the old.

They have no real answers,
But might keep you alive,
You might languish and struggle,
But don’t expect to thrive.

They have Band-Aids and tubes,
A whole chest of survive,
But the full life, the whole,
Cannot be revived.

Reduced to a photo,
A face on a screen,
Neither dead nor living,
But somewhere in between.

Well, that just won’t cut it,
This side of the line,
No thank you to compromise,
I want back my life!

Preconceived Notions Surrounding Social Media Groups

Far too many people have preconceived notions and a basic misunderstanding of the nature of Facebook groups and of our interactions within them. In short, our groups too often get a "bad rap" that is neither deserved nor true.

Our Gastroparesis support and advocacy groups are not simply places where we "vent," although we do vent. Many of our members have no other place to do so, as their families and friends dismiss and refuse to believe their struggle. The groups, then, are the one place where members feel understood and accepted. And far from being mere "gripe sessions," such posts might better be viewed as self-care and self-help, as they attempt to put into words the feelings that weigh heavy on the hearts of our members, who seek acknowledgment, compassion, and, sometimes, advice for moving forward.

The groups are not merely boards for "bashing" physicians, either, although that does occur. It can be difficult to find doctors who are both knowledgeable of the life-altering effects of GP and who care about the overall well-being of their patients. In addition, sharing bad experiences often generates discussions about how to better communicate with physicians and how to advocate for assistance, affords members the opportunity to suggest possible remedies to obstacles and problematic interactions, and flashes a warning sign about healthcare providers who consistently under-serve their patients.

Further, the groups are not hosts of misinformation, although we do combat that. By permitting members to ask questions, wonder aloud, and speak freely (or, at least, as freely as Facebook permits), we offer rational explanations, discuss research and information from credible sources, and share personal experiences and perspectives. We offer and flesh out what is accurate and inaccurate, what is helpful and harmful, and what is perhaps worth pursuing or dismissing.

And, finally, the groups are not "negative" pits of despair, although we see many who have been dismissed, mistreated, beaten down, and lack hope. We combat this by offering listening ears, helping hands, and understanding hearts. We would rather our members be outspoken about their worries, fears, and sense of hopelessness than hide their pain and suffer in silence. If we do not know, then we cannot help. We hear the cries that others have ignored and give voice to the pain so that "healing" can begin. But we also share uplifting stories, small and large "successes," and moments of overcoming. We hear of weddings, births, graduations, successful treatments, good days, and reconnections with families and friends. We express both despair and hope, as is the case with nearly all humans. We laugh, cry, commiserate, pray, and wish well.

In short, our groups are sources of physical, emotional, mental, social, and spiritual support. They are the center of information-sharing and advocacy efforts. They are our best attempt at getting out accurate information regarding the causes, effects, and available treatments and resources for our illness. They are a one-stop shop where we treat the person as a whole and not simply as a diagnosis. They are self-help and education communities. They are the light at the end of a sometimes very dark tunnel and a source of encouragement and hope for those who the medical system and families and friends have failed. They are "home" to both those who are isolated and lack basic knowledge and support and to those who wish to offer such knowledge and support.

And, so, I challenge and encourage healthcare professionals, researchers, legislators, the media, pharmaceutical and insurance companies, loved ones, and the general public to lose their preconceived notions and open their eyes to the benefits of social media-based support communities. We are so much more than you have imagined.