PLEASE SUPPORT H.R. 1187: Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017

Please support H. R. 1187, the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017, which was introduced in the House Energy & Commerce Committee by Rep. James F. Sensenbrenner, Jr. (R-WI), on February 16, 2017, and referred to the Subcommittee on Health on February 17, 2017. This bill would expand research, increase funding, and promote awareness and understanding of devastating functional gastrointestinal and motility disorders which greatly impact the lives of millions of sufferers.

These disorders, which include gastroparesis, Irritable Bowel Syndrome, dysphagia, dyspepsia, GERD, Cyclic Vomiting Syndrome, Chronic Intestinal Pseudo-Obstruction, and numerous other digestive tract disorders and diseases, are truly life-altering, commonly debilitating or life-threatening, and often have few (or no) safe, reliable, and effective treatments or cures. Available treatment options are frequently accompanied by serious side effects and risks as well. The millions who suffer from FGIMDs deserve awareness and expanded educational efforts on their behalf, increased research funding, and better, more effective treatments or cures.

A brief summary of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017 as established by the Library of Congress reads as follows:

“This bill amends the Public Health Service Act to require the National Institutes of Health to expand, intensify, and coordinate its activities with respect to functional gastrointestinal and motility disorders (FGIMDs), including by:

• expanding basic and clinical research into FGIMDs by implementing the research recommendations of the National Commission on Digestive Diseases,
• providing support for the establishment of centers of excellence on FGIMDs,
• supporting innovative approaches to educating health care providers and patients regarding strategies that improve patient-provider relationships and care,
• directing the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to provide the necessary funding for the continued expansion and advancement of the FGIMDs research portfolio, and
• directing NIDDK and the Eunice Kennedy Shriver National Institute of Child Health and Human Development to expand research into FGIMDs that impact children.

The Department of Health and Human Services may engage in public awareness and education activities to increase understanding and recognition of FGIMDs.”

Please ask your congressional representative to expand research, increase funding, and promote awareness of functional gastrointestinal and motility disorders by supporting H. R. 1187. You can find additional information and read the text of the bill at https://www.congress.gov/bill/115th-congress/house-bill/1187 or https://www.govtrack.us/congress/bills/115/hr1187. You can find contact information for your representatives at https://www.govtrack.us/. You can find a sample letter to send to your representatives at https://www.iffgd.org/advocate-for-digestive-health/taking-action-in-washington/sample-letter-to-congress.html.

Thank you for your consideration!

*Please note: This bill was formerly known as H. R. 2239, H. R.  842 and H. R. 2311. All three bills died in previous congressional sessions; H. R. 1187 is the current (115^th Congress) reintroduction. It is essentially a new bill and must begin the entire process again if it is to be passed. At the time of this writing, this bill had only 7 cosponsors, and we desperately need additional support.  Skopos Labs, a data analysis company which evaluates congressional bills, has given H. R. 1187 only a 14% chance of enactment.  (This seems bleak, but the bill received a mere 3% chance of enactment during the last congressional session).  This bill must pass out of committee, be approved by both the House and Senate in identical form, and be signed by the president by January 3, 2019, to be enacted as law.  If it fails at any point in the process, it must be reintroduced in the next congressional session and begin its journey again.  The bill gains support with each reintroduction, but we need advocates to contact their representatives and encourage them to cosponsor the bill in order to make significant progress toward enactment.

Sources:

“H.R. 1187 — 115th Congress: Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.” www.GovTrack.us. 2017. January 31, 2018. https://www.govtrack.us/congress/bills/115/hr1187

“H.R.1187 - 115th Congress (2017-2018): Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.” Congress.gov | Library of Congress - https://www.congress.gov/bill/115th-congress/house-bill/1187/all-info

ABOVE THE BRIM

ABOVE THE BRIM

In the pit, I awaken, much to my horror,

Sameness before me, day after day,

Dark, bleak, cold as midnight,

The light far above me, distant, faint.

In this world where I linger and wait,

In the midst of such pain and such wailing,

Slowly stir, try to move, try to breathe,

But my body betrays me, seeks to fail me.

Crawl to my knees, dazed and in a haze,

Muster up the nerve to face the day ahead,

Cruel and unrelenting pass the hours before me,

I and my cellmates – barely alive, the walking dead.

My gaze once again falls upon them,

The ill, the suffering, the forgotten,

I have lived so long in the thick of this,

No escape, no release, hope wearing thin.

They beseech me to help, but what can I do?

No strength, little courage, few plans,

I stand on my feet and glance upward,

And yet again begin this macabre dance.

I long for the radiance shining downward,

Wonder why I was sentenced to this fate,

What crime or wrongdoing have I committed?

My answer – and my release – I await.

One last look at the masses which surround me,

Piteous souls lost in abandon and torment,

Grab onto the high walls of my prison,

And slowly, methodically, begin my ascent.

I clamber and cling and claw my way upward,

And gradually make a measure of weak progress,

Stumble backward, regain my footing, and continue,

Hoping this time for some minor success.

I remember with fondness my time above ground,

Days filled with love, laughter, and delight,

Nothing but joy and grand achievements,

But wait… something’s off… Is that right?

In my doubt, I look downward, uncertain,

Into the abyss of tattered, sorrowful souls,

Crying out for understanding, for assistance,

But I am one, and I struggle; I am not whole.

There are demons in the chasm, I am aware,

Ego, apathy, bitterness, hatred, and strife,

Cruel, skilled masters of chaos and abuse,

Who add nothing more than anguish to this life.

I am saddened but reminded I am powerless,

Cannot alter the others’ fates or their plights,

Cannot possibly face the monstrous hurdles,

So, once more, resume my climb to the light.

I am close to the summit I have longed for,

Near the top – salvation is in sight,

But it is not quite as I had imagined,

Not as I remembered – no, not quite alight.

At the brim, I peek over, expectant,

But the bright rays I envisioned are not there,

Is my memory mistaken, glossed over?

If not above me, beyond, then from where?

From below me, a low murmur escapes,

A soft voice from the depths, not above,

I hear Him quite clearly, no mistaking,

“It is a gift, not a punishment, my love.”

Not the words I anticipated or welcomed,

But true, and I knew it in an instant,

At the brim, closed my eyes and relented,

Released my grip and began my descent.

Falling into emptiness and blackness,

Ever downward till the bottom I reach,

The gravity and finality of my choice,

Weighing heavily upon me, I weep.

But as the tears fall wistfully and freely,

My eyes catch a glimmer, a soft flame,

In this black Hell of eternal damnation,

My heart and soul feel hopeful and ablaze.

For the illumination which grows ever brighter,

Is within me, all around me, it surrounds,

Never far from above as I imagined,

But a product of compassion so profound.

It lives among the lessers, the others,

And it grows ever-brighter in my soul,

When I let go of false remembrances and desires,

Accept the Truth which fulfills me, makes me whole.

PATIENT-CENTERED CARE? WE CAN DO BETTER!

And yet again, I must write about a patient who has gone through needless agony and expense in an attempt to garner assistance from one of the "top" motility clinics in the country only to be denied the help she so desperately needs. In this particular case, she prepared exactly as instructed for a procedure for which she had waited for years and upon which she placed her final hopes. She researched, obtained the necessary approvals, spent all her savings, and traveled to this clinic multiple times in preparation for the procedure. But an important instruction was omitted from her preparation papers -- overlooked, missed by all involved -- and so she arrived at the clinic only to be told she could not undergo the procedure after all. A mistake -- most likely innocent, as that does happen whenever human beings are involved, but a devastating oversight for the patient.

And your response, Good Doctors? Not compassion or empathy. Not an offer to make things right free of charge. Not even an apology. No, you sent her packing, devoid of hope, out of options, and ready to give up on everything. Can she reschedule after making the changes she needs to make to undergo the procedure? Absolutely. But she cannot gather the necessary funds to return, and she is so emotionally damaged she does not know how to pick up the pieces.

Good Doctors, you simply MUST understand that patients spend months getting referrals, scraping together funds they cannot really afford to spare, and travel long distances to see you. Not only that, but they prepare emotionally. They are frightened, terrified that this procedure will not improve their condition, afraid to hope their symptoms might actually lessen, and yet hopeful against all odds that it will. They FULLY invest and view you as their salvation from the horrors of this cruel illness. Do you not see that the patient before you is begging for someone, anyone, to offer a kind word, a little compassion, a shred of decency?

Now, perhaps it is unfair to saddle you with the entire burden of "hopes and dreams," but it is absolutely appropriate to expect you to comprehend the physical, emotional, and financial burdens your patient bears. It is absolutely appropriate to expect you to behave like a decent, caring human being. And it is absolutely appropriate to expect that if you have made an error, you offer the patient before you a resolution which does not create additional burdens for her.

What you have offered instead, and what I see you offer time and time again, is apathy, a lackluster effort, callous and inhumane treatment, and a rejection of your oath, as I see it.

I say again: If you cannot do any better than this, CLOSE YOUR DOORS and at least spare my people the expense! And I can promise you, from now on, I am going to start advising people to DEMAND REFUNDS! Oh, I know this is radical and likely will not produce the immediate results I seek for these patients, but I can also promise you this...

If patients begin standing up and fighting this sort of atrocity and injustice, it WILL eventually turn the tables in our favor. And in the meantime, you will be forced to respond and deliver an adequate explanation as to why this sort of reparation cannot be made. Make no mistake: patients share information. Your reputation is not flawless and is plummeting quickly.

YOU SHOULD BE ASHAMED!

MUCH ADO ABOUT DOM

*Note: I am just a patient, a Gastroparesis patient searching for answers for a community which desperately needs attention, and this is just a copy of my Facebook post.  My apologies if the following seems harsh or overly-aggressive, but my people are suffering, and the status quo is simply not going to cut it.  Someone must speak out for radical change, and if not me, then who?  Please, if I am wrong, offer clarity.  Correct me and I will pass along the proper information.

One further comment -- a personal story really.  My former GI, a motility specialist, prescribed Domperidone and instructed me to obtain it through a pharmacy in Canada or New Zealand.  This physician actually handed me a prescription, along with printed information citing the pharmacies' contact information, and when I objected that this was not the technically legal path, a staff member responded to me: "What difference does it make.  Are you running for political office?"

Is that the atmosphere you had hoped to create?*

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MUCH ADO ABOUT DOM

How is it that our "top" Gastroparesis clinics and motility specialists do not know the proper route for prescribing Domperidone? Good doctors, if I can find the information, you can, too! 

When you advise patients to circumvent the legal process and purchase directly from overseas, you put your patients in the awkward position of choosing between following the FDA regulations or the advice of their doctor (who assumedly has their best interests at heart). Your patients trust that you are following the law and are directing them to legitimate sources of purchase -- and yet you are not. These people are stunned that they have been given misinformation by the very doctors whose advice they are expected to follow.

It would seem, good doctors, you are either uninformed of the FDA guidelines regarding Domperidone (which I find unlikely) or you are blatantly ignoring those guidelines either due to a desire to help your patients obtain the medication they need to survive through simpler (though illegal) routes or because you are unwilling to put forth the time and effort required to jump FDA hoops. I sympathize, but you must understand the consequences and the effect this has on your patients.

Your patients are often completely unaware that obtaining medications outside of the US is illegal and are shocked that you would advise them to pursue such a path. I frequently hear, "My doctor would not tell me to do something illegal. Why would he do that?" In fact, many times, your patients choose to put their faith in you and take your words as the final authority because they believe in you, and, after all, I am just an administrator in an online Gastroparesis support group. What do I know? And so they remain unaware that their medication may be confiscated at the border and that, if this should occur, they will be left without the medication they so desperately need, without an alternative source and adequate time to secure a replacement medication, and without any sort of refund for their purchase.

Beyond that, by breaking their trust in this one particular area, you have broken trust with them completely. How can you now convince them you are honest and upfront about other issues? Have you really researched the treatment option you are offering? Have you fully informed them of all the potential side effects and risks? Have you thought through the needs of your patient in all matter which so deeply affect their well-being? Why would they ever again believe you have told them the whole truth and are acting in their best interests?

I have addressed this Domperidone situation many times with the FDA. I have told them point-blank that people are confused as to why their doctors would give them misinformation and direct them to violate the law and that I am confused as to why this is allowed to continue. Their response to me, while sympathetic, has been that it is "disappointing" to hear that doctors are handing out such advice (and that they should not be) but that the FDA is not the body of enforcement. In other words, the FDA lays down the law but has little power in what happens after that. As I see it, the FDA has washed their hands of responsibility as have physicians.

Now, I do not like the FDA regulations. As a matter of fact, I detest them. But we have them. And if we are not going to do away with them anytime soon, then we need to find a way to help patients legally obtain their life-saving Domperidone. There is a process in place, and I am guessing most of the players (with the exception of patients) know the details of this process. Why are we playing games that ultimately harm the patient? While the powers that be "duke it out," my people suffer. Get on board with the process or change it.

And I say to you, good doctors, please stop placing your patients in a position where they must break the law to stay alive. It is UNACCEPTABLE! You know the proper route so advise your patients accordingly and put forth the necessary effort to help them obtain their medication. Cumbersome and time-consuming? Yes. But you have a duty to do what is best for those you serve. Take it up with the regulators, and, in the meantime, do what you must do to help your patients legally obtain Domperidone.

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For all who are interested, this is the post I generally share in the group. If I am the one who is misinformed, please, by all means, give me clarity...

Regarding DOMPERIDONE...

I am going to post the information (below) I post almost every time this medication comes up. I realize some of you dispute this. All I can tell you is that I have contacted the FDA 7 times now (yes, 7!), and this is what they have repeatedly told me. I have explained to them that I admin a group of more than 17,000 and, so, it is imperative I deliver accurate information, and they have assured me this is accurate.

I also realize doctors are not telling you this and are not prescribing in this manner. Again, all I can say is that, according to the FDA, they should be. It puts the patient in a very awkward position when the doctor is telling him/her one thing and an admin in a Facebook group somewhere is saying another. I have raised this issue with the FDA on numerous occasions, and their only response to me is that they are not responsible for oversight and execution but that doctors should NOT be operating in this manner.

Further, I know most of you obtain your Dom in ways other than the FDA's IND program. I make no attempt to direct your behavior; nor do I pass judgment on it. I clearly understand all the reasons for this. (In fact, personally, I detest the FDA regulations and fight every day for them to be changed.) But my goal is ALWAYS to provide the legal, most accurate, updated information possible, and so I post what I have been told to be correct by the very body which regulates all drugs in the US. And, in addition, I do not wish to see any group members in a situation where their medication has been confiscated and they have no recourse. I know many of you have ordered overseas (or from compounding pharmacies) for years with no issues, but I also know the FDA has begun cracking down on these practices rather severely lately. This can and HAS happened to members of this group.

If you doubt this information, I encourage you to see the FDA packet at https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/UCM520728.pdf or to call the FDA directly at 1-888-463-6332. I do not get paid to be their spokesperson, and I am certain they are tired of hearing from me.

So, here is the most up-to-date, accurate legal information I have. I will not engage in argument over this. You are free to believe as you wish. This is the best I can do. If you dispute it, please refrain from commenting; rather, please contact the FDA directly.

*******************************************************

According to the FDA, there is only one pharmacy (inside or outside the US) whereby patients may legally obtain Domperidone: Dougherty's Pharmacy in Dallas, Texas. You can find Dougherty's on the web at http://www.doughertys.com/ or reach them via telephone at (214) 373-5300. The FDA has stressed that this is the ONLY legal method for obtaining Domperidone available to US residents.

It is a common misconception (even among doctors) that Domperidone may legally be obtained outside the US, but this is not the case. US residents seeking to obtain Domperidone outside the US technically do so in violation of regulations and run the risk of having their Domperidone confiscated at the border. This can and has occurred. In this case, the patient does not receive his/her Domperidone, nor does s/he receive reimbursement for the order.

It is also a common misconception that Domperidone may be obtained through compound pharmacies in the US. Again, this is a violation of FDA regulations. Compounding pharmacies are prohibited from making and distributing Domperidone and do so at risk of being fined. The FDA fines these pharmacies and orders them to cease production/distribution once they have been made aware. Many patients have found that local compounding pharmacies which once filled/refilled their prescriptions for Domperidone have now been banned from this practice. When this happens, the patient is left with no recourse and no access to the medication.

Here is a link to the FDA's website regarding how to obtain Domperidone: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm368736.htm

Their website instructs, in part, "'Patients 12 years of age and older with certain gastrointestinal (GI) conditions may be able to receive treatment with Domperidone through an expanded access investigational new drug application (IND). These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients who are eligible to receive Domperidone have generally failed standard therapies. Expanded access INDs facilitate access to investigational drugs (such as Domperidone) for patients with serious diseases or conditions for which there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient’s disease or condition. In addition to other applicable requirements, an IND must be in effect prior to the importation, interstate shipment, and administration of Domperidone."

*Please note that we seek to provide you with the most accurate and up-to-date information possible, but we cannot and will not try to direct your behavior. Your choices are your own, and we make no attempt to control them. If you have any further questions, we would advise you to call the FDA directly at 1-888-463-6332.*