FAQ: Cortisol Pumping Method

What is Cortisol Pumping?

The concept of Cortisol Pumping is the use of solu-cortef (inject-able version of cortisol when mixed with saline or bacteriostatic water) used in an insulin pump programmed to disperse cortisol according to the natural circadian rhythm by programming rates of delivery into the pump. This method bypasses the gastric passage and is able to deliver cortisol in a more natural way. With an infusion pump, an adrenal insufficient patient can receive a constant supply of cortisol and can lesson the instability experienced with oral steroid cortisol replacement. Side effects due to malabsorption can be decreased and patients have reported to have improved sleep, weight management and experience an overall improvement in their energy levels and sense of well-being. This method has also been shown to lessen the prevalence of adrenal crises and hospitalizations due to low cortisol.

Though this method is not a cure for adrenal disease, it is an option and a ray of hope for those who are struggling with quality of life.

According to a survey done by the Adrenal Alternatives Foundation[1] concluded that 94.2% of the 52 anonymous cortisol pumping patients reported that the cortisol pump had improved their quality of life.

Is Cortisol Pumping FDA approved?

Adrenal Alternatives Foundation is actively working to gain FDA approval for the cortisol pumping method, but that involves years of clinical trials, patient studies and funding. We will achieve this one day, but until then, we are educating patients that FDA approval is not necessary to safely and legally begin cortisol pumping under the care of a licensed physician. Use of the infusion pump for adrenal insufficiency is considered “off label.”

Infusion pumps have long been approved for the administration of medications. According to the Department of Health and Human Services Centers for Medicare and Medicaid Services Medicare Coverage Issues Manual Section 60-14 A: “6. Other uses of external infusion pumps are covered if the contractor’s medical staff verifies the appropriateness of the therapy and of the prescribed pump for the individual patient.”

In addition, according to the recently passed Right to Try Act, patients have legal rights to access to life-saving treatments which are not yet FDA approved.  The act states the following:

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A (21 U.S.C. 360bbb–0) the following: ‘‘SEC. 561B. INVESTIGATION ‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE PATIENTS. ‘‘(a) DEFINITIONS.—For purposes of this section— ‘‘(1) the term ‘eligible patient’ means a patient— ‘‘(A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); ‘‘(B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— ‘‘(i) is in good standing with the physician’s licensing organization or board; and ‘‘(ii) will not be compensated directly by the manufacturer for so certifying; and ‘‘(C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent.”

According to the above legislation, adrenal patients meet the criteria for legal use of an infusion pump to administer glucocorticoid medication.

How do I get a pump?

The first step to cortisol pumping is establishing a care plan with a licensed medical professional. This can be a difficult challenge when trying to find a physician to manage your care with the pumping method, as most have never heard of it. This is why Adrenal Alternative Foundation has volunteers on our clinical advisory team willing to communicate with your healthcare team to help you establish a plan regarding your care on the cortisol pumping method.

It may take you many tries to find a physician willing to manage your care with the cortisol pumping method. Send your research, your health information, everything you can to the endocrinologist before your appointment so they are aware of your intentions beforehand. It may benefit you to write a letter to the endocrinologist prior to your appointment that explains your diagnosis, failed treatments and desire to be on the pump. They may or may not be receptive to your request and alerting them of your intentions beforehand may save you time, money and effort.

Will insurance cover pumps and supplies?

What your insurance will cover is completely dependent on your specific coverage plan and insurance company. If you are denied, you can always file an appeal. Visit this link to download the example appeal letter you can fill out with your information to appeal your insurance company’s denial.  

Adrenal Alternatives Foundation has also aligned with the organization CR3 to help adrenal patients acquire pumps in a safe and legal manner. Visit this link to apply for pump assistance.

It is also an option to cash purchase pumps and supplies specifically from companies such as Omnipod and Medtronic if you have a prescription from your overseeing physician.

Is cortisol pumping safe?

Adrenal insufficiency requires adequate cortisol replacement in the form of steroid medications. With the cortisol pumping method, patients can bypass the gastric pathway and absorb their life-sustaining medication better. This treatment is revolutionary for hypermetabolizers and for those with gastro-intestinal problems or malabsorption issues.

The pump truly puts adrenal patients in control of their cortisol distribution in a way that steroid pills cannot. In situations of physical or emotional stress where “updosing” is needed, the pump can immediately administer a bolus, which is extra cortisol administered through the pump canula at the amount you select. Instead of having to wait for pills to metabolize, the cortisol can be absorbed faster and can help prevent adrenal crisis.

Cortisol pumping is not a cure for adrenal insufficiency and is not a treatment that is right for everyone. If you are well managed on steroid replacement pills, being on the pump method may not be necessary to achieve quality of life.

Do I still need an emergency injection on the pumping method?

An adrenal crisis is defined as a life- threatening, medical emergency caused by insufficient levels of the hormone, cortisol. It will lead to death if left untreated and must be quickly addressed with the administration of an emergency cortisol injection. The pump is not a replacement for acute adrenal crisis care. Adrenal patients should always carry an emergency injection and administer it immediately in the event of an adrenal crisis.

More information on cortisol pumping can be found on the cortisol pump advocacy tab on our website and also in the book A patient’s guide to managing adrenal insufficiency.


[1] CORTISOL PUMPING SURVEY

In-text: (adrenalalternatives.com, 2020) adrenalalternatives.com. (2020). Cortisol Pumping Survey. [online] Available at: https://docs.google.com/forms/d/1eWYZjIFP9HRJDosvdimJnOr8p54Rmpx_2A4Xz40f77A/edit#responses

THE ADRENAL ALTERNATIVES FOUNDATION IS REGISTERED WITH THE IRS AS A 501(C)3 NONPROFIT ORGANIZATION. WE ARE A PATIENT EMPOWERMENT ORGANIZATION THAT ENCOURAGES, EDUCATES AND ADVOCATES FOR SUFFERERS OF ALL ADRENAL DISEASES AND ARE GUIDING ADRENAL DISEASE SUFFERERS TO EVERY POSSIBLE RESOURCE TO MANAGE THEIR HEALTH.
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Can you donate blood with adrenal disease?

Donating blood is one of the most selfless acts a person can do, but when you have a life-threatening illness such as adrenal insufficiency, there are questions as to whether you are allowed to donate blood or not.

Can adrenal disease patients donate blood?

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The answer is complicated.

Some countries/territories allow blood donation from adrenal patients and others do not. It is ultimately dependent on the regional medical director’s decision of a particular organization.

According to the Pituitary Foundation, Addison’s disease is listed as a permanent deferral which means those with this diagnosis are permanently banned from donating blood.

The Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee states that anyone diagnosed with any form of adrenal failure “Must not donate.” 
When we searched the American Red Cross website for adrenal disease information, we found no search results that pertained to whether adrenal patients could donate or not.
You can review the full eligibility requirements here.
To answer, the original question, Can you give blood with adrenal disease?
It depends on where you live and what organization is accepting blood donations.
If you are eligible to donate in your area, remember it is also a personal choice.  You should discuss it with your doctor to determine your risks and benefits of blood donation. 

 

 

 

 

 

Sources:

https://www.mskcc.org/about/get-involved/donating-blood/additional-donor-requirements/medical-conditions-affecting-donation

https://www.pituitary.org.uk/information/living-with-a-pituitary-condition/donating-blood/

https://www.redcrossblood.org/donate-blood/how-to-donate/eligibility-requirements/eligibility-criteria-alphabetical.html

https://www.transfusionguidelines.org/dsg/wb/guidelines/ad003-adrenal-failure

 

Maja’s Adrenal Disease Story

Maja Bergma shares her amazing story of diagnosis and her quest to spread awareness on adrenal disease!

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First when diagnosed, I was happy! I thought, Now they can finally fix me! I can get my energy back and catch up on everything in my life that just got put on hold over the years I felt so sick. But I soon realized that fixing me, was not so simple. I was hoping to be able to work/study/travel – do all those things again.

Let’s just say that I got kind of a reality check, realizing that just because you get a diagnosis does not mean that you can get fixed up and well so easily. I feel like the medication keeps me alive, but it’s not enough to let me really live!

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Before my diagnosis, I used to be kind of a high achiever.   I was the one always helping others and now I´m the one needing help.  This disease has turned my world kind of upside down. I had to re-evaluate my self-worth/self-image. I am still learning to be kind to myself, and still working on knowing how to save cortisol/energy.

In the beginning the stress of feeling bad for being sick, feeling like a bad wife/mother for not being able to do all the things I want to do was not helping me feel better!  It was a tax on my soul and like an energy thief.

I see that this is a struggle for many in the support-groups too! You are not alone! I’m now trying to be my own best friend. I don’t need to be so hard to a friend having a rough day. I would not be so hard on another person in the same situation, so I need to be kind to myself too! This is my new way of thinking.
I frequently tend to get fevers, when I exert myself – and that´s rough when one need to up-dose for that. My doctor, said I need to come to peace with that that´s, the way my body works. So I´m working on acceptance, but still fighting for more help, better treatment options.

I had to stop driving my car, and that´s sad but there was no other alternative. This summer we bought a new, smaller home because of my situation. Our new home is  without stairs and no large garden. We are currently getting it altered to work even more practically for me. For example, with low blood pressure, I can´t safely carry laundry up the stairs from the basement, and showering takes a lot out of me so I need to sit and do that to not fall when my bp falls and I feel faint. I don´t want to hurt myself any more than necessary. Our new home works better with my low energy level and my bp trouble.
I realize I can’t live on false hope any more – that I will feel like I used to soon. I have to choose to live my life that functions well for me right now. I feel like I can win a little every day!  I do hope to get to try a pump in my lifetime, and if I can’t,  I do hope that other AI generations after me, will get the chance – if they don´t work well on steroid pills.
I need to rest and sleep a lot. I see many not doing well on HC, needs to sleep a lot too. I try to do things, rest a bit, and do some more. I try to pace myself to get things done. I highly recommend pacing for those of you who struggle, just like me.Also a slow-cooker, made my cooking less dangerous – with lower risk of burning food or the house down! Haha!
My warmest recommendations for other tired AI sufferers needing to get a feeling of being able to win, SMILE! Currently working on trying to help my whole body heal – since being sick for so long without diagnosis. I have been so broken down and know what its like to feel totally broken. I now realize the war that was goes down on the inside of me and why I was get tired on a kind of a cellular level.
I have needed to learn to be more kind to myself. I realize that this disease, I can’t fight with force (that only leaves me exhausted) – it´s more about outsmarting it… So now I´m working on that. Trying to get me the best help!22008247_1520918134596484_4646301107067754700_n.jpgI believe that other diseases in combination with AI, makes it harder to manage it. We see this proved when we look at how the cortisol curve looks in those who have normal adrenal function when they do get sick. I believe this is very important information for better treatment in those with many diseases at once.
In addition to AI, I have upset stomach problems, but they have become better after I get celiac diagnosis and got that treated. But I still get sick to my gut in the gaps between medications. My bp often seems to run low so I recently started to use a walker. I use my husband for support for the longest time, at first – but I want to be able to walk around with out him also so I don’t fall when my bp suddenly decides to drop.
I really hope to see more research about cortisol. Prof Hindmarsh has done some amazing things in his research, I just hope we, all over the world – soon can reap the benefits of his knowledge on sick-rates, dosing and general pumping! Since I have seen that the quality of life so much improves for those going on the pump, who do not feel well on steroid pills alone. I wish that there would be more awareness, to make changes for the better for all AI sufferers. Prof Hindmarsh – to me is like a superhero, he is doing this research for the kids. I can’t even imagine being a kid, with low cortisol and what that would do to a family. In Sweden there is a book coming out soon, about kids with AI and their families – the book will be called “ständigt på vakt” translates to “Constantly on guard”. Happy that the book will come out and rise AI awareness!
Well I must say, even if my life is far from optimal – I´m so grateful, to be alive!  I know that today might not be optimal, but as long as I´m alive, I at least might have a chance of a better life. I hope get a pump and get more on top of this! As long as there is life – there is hope! Heard a woman on her 3 day of pumping saying she felt healthy, and she never did that on pills – I wish that one day I can say that… I feel healthy!
It’s with a sad heart, I have seen too many in the support-group die these last months. And a woman here in Sweden died before getting diagnosed and treated. She was tested but did not get help fast enough. This is depressing and shows how much we need to raise awareness around AI even today in these modern times! We must work on awareness, in memory of those in the AI community, who left us too soon: for our-self and hope for a long and more healthy life; and for those who will come after us!
Maja created the collage below to help raise awareness on adrenal disease! 48607316627_1db35b4b4c_o.jpgThank you Maja for bravely sharing the truth of your battle with adrenal disease. We will make sure YOU have a pump and your life improves.

 

That’s what Adrenal Alternatives Foundation is here for, to lead patients to ALL adrenal alternatives. ❤

 

 

Interview with Julia Anthony, Founder of SOLUtion Medical

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Adrenal Alternatives Foundation is proud to be an affiliate with SOLUtion medical, which is creating auto-injecting technology to manage adrenal crisis. We were privileged to sit down with SOLUtion’s Founder, Julia Anthony, for an interview regarding her work in the adrenal community.

Q- Please introduce yourself.
A-Julia Anthony. I’m currently 27 and live in Philadelphia, PA.

Q-How were you diagnosed with AI?
A-I was diagnosed with Salt-Wasting Congenital Adrenal Hyperplasia (SWCAH) at birth.

Q-What are the challenges you see within the adrenal community?
A-I’ve had to teach people about SWCAH my entire life – friends, family, classmates, coworkers…paramedics, ER staff, and the nurses at the Universities I attended. While the former is somewhat understandable, the later is not. This is not to say self-advocacy isn’t important. On the contrary, it is vital. However, awareness about adrenal insufficiency is significantly lacking, even within the medical community. In some ways, adrenal insufficiency and the conditions that cause it are hidden and become clinically significant only during times of physiologic stress. For this reason, people unfamiliar with adrenal insufficiency and adrenal crisis sometimes have a hard time understanding the life-threatening severity of such conditions. The need for continued and improved systemic awareness about adrenal insufficiency, adrenal crisis symptoms, and how to properly administer life-saving medication during emergencies is paramount.

Q-How would you address those challenges?
A-In addition to incorporating user feedback into its design, SOLUtion aims to broaden the scope of public knowledge regarding life threatening adrenal insufficiency conditions. SOLUtion is proud to be collaborating with, among others, Adrenal Alternatives to promote awareness.

Q-What is one thing you wish the medical endocrine society understood about managing adrenal disease?
A-I remember being carried over the shoulder of my mother through the emergency bay doors of Temple Children’s Hospital; life a swirl of lights and noise, too tired to purposefully move yet my body shaking with fever. This was one of many adrenal crises I experienced when I was little, and each door we passed through felt like peeling away the layers of an onion, each portal one checkpoint closer to a hospital bed and some relief from the aching, vomiting, and headache. After having experienced many “tune up” visits to the emergency room, the reverse scenario became a sharp reminder that each door we walked out of led me closer to a world of people with varying degrees of understanding and empathy towards my medical situation. While doctors, support groups, and immediate family are bubbles of knowledge, help, and hopefully comfort, managing adrenal insufficiency conditions and relating to the rest of the world can be challenging. Though some of these frustrations are outside of my control, others, like awareness, can be changed. I hope members of the medical endocrine society realize this discrepancy and utilize their power to learn not only with their fellow members, but also teach the many people not a part of the Society.

Q-Tell us about your upcoming Twistject product?
A-I founded SOLUtion Medical out of personal experience struggling to properly use the current Act-o-vial® delivery system in times of adrenal crisis. The current standard of care in times of adrenal crisis for these conditions includes an Act-o-vial® requiring an average of twelve user steps for injection. The Act-o-vial® delivery system was designed to be utilized by trained medical personnel and not a layperson or an individual living with adrenal insufficiency. If a patient is in an adrenal crisis this is extremely difficult, if not impossible, to self-administer. The TWISTJECT™ autoinjector by SOLUtion provides users reliable life-saving care and reclaimed confidence in times of adrenal crises. TWISTJECT™ is an all-in-one reconstitution device specifically for drugs that require resuspension and injection in emergency situations. TWISTJECT™ (1) stores the diluent and powdered medication components separately (2) mixes the diluent and powdered medication, and (3) auto-injects the reconstituted medication.

Q-What challenges are you facing while creating this product?
A-Designing a functionally reliable device and that speaks to all stakeholders’ needs, including but not limited to the end user and the medical community, is and will continue to take creative problem-solving skills.

Q-Best case scenario, where you do see SOLUtion medical in ten years?
A-SOLUtion’s TWISTJECT™ will be in the purses, backpacks, and sports bags of people throughout the United States and Canada, if not other parts of the world. SOLUtion’s collaboration effort with Adrenal Alternatives and other adrenal insufficiency Foundations and Organizations will result in improved awareness, including a mandatory nationwide CEU course for medical personnel. Lastly, I hope to address the lack of emergency medication on airplanes for those with adrenal insufficiency.

Q-What is the main thing you want the public to know about your product?
A-As a young woman with Salt-Wasting CAH, I’ve set out to solve a long-overdue problem. It is time end-users’ voices are heard and their feedback incorporated into the design of the product they must use to save their lives. TWISTJECT is designed to be as complex as human and as simple as possible. By coming together as a community of people with rare diseases, we will continue to forge ahead and make a difference.

Adrenal Alternatives Foundation is joining SOLUtion Medical with their social media campaign #SubmitMyKit to raise awareness!

Details below-

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Thank you, Julia for interviewing with Adrenal Alternatives. We are thankful for the work you are doing and proud to be an affiliate with SOLUtion medical!

For more information on Julia’s TWISTject device, please visit her website – https://www.solutionmedllc.com/

6 Things to Remember when a loved one is battling Adrenal Insufficiency

6 Things to Remember when a loved one is battling Adrenal Insufficiency

 

Perhaps you have come across this article because you or someone you love has just been diagnosed with Adrenal Insufficiency. I am writing this article because I have been in the front lines of this fight alongside someone I loved. 

Those of us unfortunate enough to cross paths with this situation will tell you the naked truth; A.I is no laughing matter. In fact, it can be downright debilitating.

Don’t be defeated; all is not lost. When life bears down upon you in such a unfair way, you must push back with even greater determination. Sometimes, however, it can be difficult to even see the way forward. I have been a part of the AI fight for almost ten years and I will share with you the things that I wish I would have known sooner.

  • Take your diagnosis seriously!


    A.I is no laughing matter. You or the one who was diagnosed have a fight for quality of life on your hands. A.I can worsen if left undiagnosed, unchecked, or untreated and can even become life-threatening. The sooner you act upon it, the better you will be able to mitigate the effects of AI. My then-girlfriend began experiencing symptoms of AI almost 10 years ago. The tiredness, the diet changes, the sleep paralysis were all chocked up to stress, depression, etc. It took 5 years to get a proper diagnosis identifying what was actually wrong. By this time, AI had done so much damage that her adrenals were in total failure and beyond recovery. Do your best to take action ASAP.

  • Don’t despair; there is support out there.


    There are others out there that are dealing with the same circumstances you may be currently facing. These people can certainly help remind you that you are not alone in this fight. However, just like in any community, remember to associate with the right people. There will be those who have succumbed to despair and after all, misery loves company. Surround yourself with those who are positive. Learn from those who have found ways to make the best of their situation. In addition to this, there are advocacy organizations, such as Adrenal Alternatives Foundation  which can help inform you in the fight against AI.
  • You’re going to have good days and bad days.


    Go ahead and come to terms with this one. Depend on the severity of your diagnosis, you are not going to feel like a ray of sunshine every day. Don’t beat yourself up. Don’t tell yourself that you need to need to be doing everything your healthy peers do. If you are having a bad AI day, then do not push yourself! Remember, you do not have the advantage of health that your peers have. Don’t let others pressure you into doing more than you can handle that day. You may have to tell them “no”. You may have to insist. There are many people who won’t understand your situation. Do not allow them to get under your skin or make you feel bad.
  • If your loved one has AI, support them as best you can!


    Following up on the last point, people suffering with AI are not going to be at 100% very often. If your loved one has AI, please be understanding and patient with them. Many times they will feel depressed, defeated, or otherwise negative. I can tell you from experience that they need your special attention more than ever at these times. It can be difficult on you, the caretaker, sometimes. However, don’t think that your loved one is purposefully being a downer. If they could help the way they feel, they would change it. Don’t get discouraged, though! There is a response to this situation that works a lot of the time!
  • CORTISOL, CORTISOL, CORTISOL!


    This is the juicy part. Depending on your diagnosis, there is a good chance that you need to take cortisol in order to stay alive. If you or your loved one with AI is really dragging, or seems to not be acting like themselves (for example my then-girlfriend would get overly emotional) there is a very good chance that they need to increase their cortisol intake. I’m no doctor, but I can tell you from years of experience that when the migraines start coming on, the despair starts setting in, or the will to carry on just isn’t there, a updose in cortisol is the tried-and-true answer 90% of the time.  It isn’t some sort of panacea, but it almost always has helped. Sometimes you may have to remind your loved one to up their dosage. Often, the effects of AI can be so overwhelming that the one suffering can forget to updose themselves.
  • Look into all of the methods of AI treatment.


    Let me be frank. The endocrinologists don’t know a whole lot about how to handle  AI. In fact, finding a good ‘endo’ can be a huge challenge. In our situation, we have tried everything from pills to shots when it comes to delivering the cortisol/steroids that you may need. If you ask my personal opinion, the Cortisol Pump method has been the best solution by far for us. Obtaining a cortisol pump allowed quality of life to return to an otherwise bedridden woman. If we had known about this option from the start, we would have gone after it immediately instead of trying the other methods.

Dealing with this disease can be a costly matter. However, the most important thing is to not give up. It is possible to get insurance to cover some things. You can definitely get to supplies you need. Talk to people, because there are those out there looking to help you with your situation. Sometimes you might get bad news for your efforts, but keep on punching, because eventually you will break through, even if it takes a while.

Even though it has been a challenge to fight adrenal insufficiency, it doesn’t make you any less of a person. I would have chosen this woman over and over again despite her diagnosis. 

Don’t give up.