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 should have access to this treatment.  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  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 and 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

Celebrating Rare Disease Day 2020

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Rare Disease Day is an observance held on the last day of February to raise awareness for rare diseases and improve access to treatment and medical representation for individuals with rare diseases and their families.

For #RareDiseaseDay we invite you to join us with the
AI Butterfly Challenge, where we are raising our hands for adrenal disease awareness.

Our objective is to flood social media (pinterest, instagram, facebook and twitter) with our butterfly photos to spread awareness on ALL ADRENAL DISEASES!

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Rare Disease Day is February 29, 2020

To participate- Take a photo with your hands in the shape of a butterfly and upload to social media using the hashtags #RareDiseaseDay and #AIButterfly!

You can edit your photo with the template download here!!

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Or, if you’d like us to edit your awareness photo send your photo to adrenalalternatives@gmail.com

 

We hope you join us in raising awareness for all adrenal disease!

Managing Adrenal Insufficiency with the Cortisol Pump

Managing Adrenal Insufficiency with the Cortisol Pump

Citation: Adrenal Alternatives Foundation

Adrenal Insufficiency and Diabetes are both difficult diseases to manage and the Adrenal Alternatives Foundation sympathizes with T1D and T2D patients. Both are serious, endocrine disorders and we are in no way downplaying the battle of diabetic patients, we are simply using it as a comparative tool to explain adrenal disease, as most people are unaware of it.

Adrenal insufficiency is a disease where the adrenal glands fail to produce the proper amounts of steroid hormones. There are many different forms of adrenal disease, but the treatment for all forms is the same- steroids for cortisol replacement.

Type 1 Diabetes is the disease where the pancreas fails to produce the correct amount of insulin, thus rendering someone insulin dependent. Both of these diseases are endocrine disorders. Both of these diseases require life-long replacement therapy. The adrenal insufficient person is dependent on cortisol. The diabetic is dependent on insulin. Both of these diseases are life threatening. Both of these diseases require daily monitoring.

Almost every cell in the body has cortisol receptors, making it a crucial hormone. This hormone impacts multiple functions of the body. Without adequate levels of cortisol, the body will go into an adrenal crisis which will result in organ failure and eventually death. Cortisol impacts blood sugar levels, metabolism, stress response, inflammation levels, aids in the immune system, affects the metabolic processes such as the salt and water balances within the body and it also greatly impacts the circadian rhythm.

Unlike diabetic patients, adrenal disease sufferers have no meter to check their cortisol levels. They must be constantly vigilant of their own personal signs and symptoms of low cortisol. and require an emergency injection if their levels drop too low. The standard treatment for all adrenal disease patients is daily cortisol replacement medication- steroids.

Medications such as prednisone, dexamethasone or hydrocortisone are prescribed to replace the deficits of steroid hormones in the body. Steroids have a myriad of side effects ranging from weight gain to emotional disturbances. Long term steroid use has been linked to damage of the bones, eyesight and even muscle tissue.  Yet, steroid cortisol replacement is the only treatment for adrenal disease. In a normal person, during situations of emotional or physical stress their body releases more cortisol. The excitement from a happy event, the sadness from a death of a loved one or the strain from exercising are examples of things that would cause the body to release more cortisol. In an adrenal insufficient person, this does not happen. They have to artificially manage their cortisol. Their personal cortisol needs may differ from day to day. No two days are the same and it is a struggle to regulate proper cortisol levels.

The most commonly prescribed steroid for adrenal insufficiency is hydrocortisone (HC). This is the bio-identical steroid medication. This medication has a blood serum half life of 90 minutes and must be taken multiple times a day. Most adrenal patients struggle with quality of life due to this mismanagement. Oral HC must be processed through the stomach and the liver before reaching the blood stream.  This causes a constant rise and fall of cortisol levels, which results in subpar function, increases mortality rates and decreases quality of life.

 

Below is an example of natural circadian cortisol rhythm without the presence of adrenal disease-

naturalCircadian

 

The chart below is the circadian rhythm of an adrenal patient on oral hydrocortisone replacement.

UnnaturalCircadian

This image was created with Clearly Alive’s Theoretical Steroid Dose Plotter

Quality of life in adrenal disease patients is vastly poor due to this lack of balance. Oral cortisol replacement cannot do what natural cortisol can. But fortunately, endocrinology research has found a solution for adrenal patients who have failed to stabilize on oral cortisol replacement medications. The concept of Cortisol Pumping is the use of solu-cortef (inject-able version of cortisol when mixed with saline) used in an insulin pump programmed to disperse cortisol according to the natural circadian rhythm by programming rates of delivery into the pump. This therapy bypasses the gastric passage and is able to deliver cortisol in a more natural way. With this method, an adrenal insufficient patient can receive a constant supply of cortisol and will not suffer the instability experienced with oral steroid cortisol replacement. Side effects due to mal-absorption are decreased and patients have been 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 proven to lessen the prevalence of adrenal crises and lessen hospitalizations due to low cortisol.

Peter Hindmarsh, Professor of Paediatric Endocrinology at University College London and Consultant in Paediatric Endocrinology and Diabetes at University College London Hospitals and Great Ormond Street Hospital for Children. He is currently Divisional Clinical Director for Paediatrics at University College London Hospitals is a pioneer for the cortisol infusion method. He has done much international research and has proven that this method improves the lives of adrenal insufficient patients.

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.

PumpAware

 

 

Sources:

 

Chauhan. Adrenal Insufficiency: Burden Of Disease And Cost Of Illness. http://www.ispor.org/research_pdfs/45/pdffiles/PDB30.pdf. Accessed May 22, 2016.

Coursin DB, Wood KE. Corticosteroid supplementation for adrenal insufficiency. Jama. 2002;287(2):236-240.

Daniel E, Newell-Price J. THERAPY OF ENDOCRINE DISEASE: Steroidogenesis enzyme inhibitors in Cushing’s syndrome. Eur J Endocrinol. 2015.

Gagliardi L, Nenke MA, Thynne TR, von der Borch J, Rankin WA, Henley DE, Sorbello J, Inder WJ, Torpy DJ. Continuous subcutaneous hydrocortisone infusion therapy in Addison’s disease: a randomized, placebo-controlled clinical trial. J Clin Endocrinol Metab. 2014;99(11):4149-4157.

Hindmarsh PC, Charmandari E. Variation in Absorption and Half-life of Hydrocortisone Influence Plasma Cortisol Concentrations. Clin Endocrinol (Oxf). 2015; 82: 557-61.

Oksnes M, Bjornsdottir S, Isaksson M, Methlie P, Carlsen S, Nilsen RM, Broman JE, Triebner K, Kampe O, Hulting AL, Bensing S, Husebye ES, Lovas K. Continuous subcutaneous hydrocortisone infusion versus oral hydrocortisone replacement for treatment of addison’s disease: a randomized clinical trial. J Clin Endocrinol Metab. 2014;99(5):1665-1674.

 

Copyright © *2019 Adrenal Alternatives Foundation* All rights reserved. Adrenal Alternatives Foundation is a patient empowerment organization that encourages, educates and advocates for sufferers of all adrenal diseases and is registered with the IRS as a 501(c)3 nonprofit organization.

 

 

Miracle Mermaid- The Story Behind the Adrenal Alternatives Foundation

Mermaids and adrenal disease……what do these two things have in common?

We all know mermaids are the mythological creatures found in fairy tales and storybooks we read as children. Many of us spent countless hours in pools and the ocean, pretending to be these fantastic, beautiful creatures…..only to grow up to find the harsh reality that mermaids don’t exist….but diseases like adrenal insufficiency do.

Winslow E. Dixon was that little girl who loved mermaids. She loved the water and idolized all things ocean. As a child, she blissfully played in the ocean waves, pretending she was a creature of the sea.

But that little girl grew up to realize that her fairytale of living in the sea wouldn’t come true. Life dealt her a stiff hand of medullary sponge kidney disease and endometriosis, which resulted in chronic pain from a young age.  This chronic pain was so severe it taxed her life and resulted in total adrenal failure- Addison’s disease. At 23 years old, this little girl grew up to find the nightmare of an adrenal crisis, never to be the same again.

Her health failed and her dreams crashed along with it.

But that little girl, all grown up now, was determined to get her life back.

She searched far and wide for options to treat her disease and discovered the promising hope of the cortisol pump.

She quickly discovered this treatment option was hard to come by.

Nevertheless, she persisted.

She visited multiple endocrinologists nationwide and was rejected by multiple doctors. No one seemed to want to take a chance on this treatment.

After two years of fighting, she decided to do it herself. She enlisted the help of a pharmacist and consulted Professor Hindmarsh and decided to take control of her health. She began the cortisol pump in March of 2018.

So where does the mermaid come in?

Winslow went from being completely bedridden and unable to function to being able to enjoy life again.  She was able to fulfill a life long dream of swimming like a mermaid, thanks to the strength she found from using the cortisol pump.

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Though the pump has not been a cure, it has helped her find better days and more quality of life.

After seeing how little resources there were on cortisol pumping, Winslow then decided to start the Adrenal Alternatives Foundation to help adrenal patients find every resource to manage this devastating disease.

When you’re adrenals fail, you are forced to find alternatives…..which are typically oral steroid pills. The treatment protocols for adrenal insufficiency have not changed since 1920. This is unacceptable. Research and treatment protocols are outdated.

For those with severe forms of this disease, oral steroid therapy is not enough to live a normal life.

This foundation was created to be the voice for those struggling with unmanaged adrenal disease.

Life may not be a fairytale, but it doesn’t have to be a nightmare.

Winslow’s story shows us that even though things may look bleak, there is always hope.

Adrenal Alternatives Foundation is here to educate the world on the TRUTH of adrenal disease and to empower patients to find the best quality of life possible.

Change is coming for adrenal disease ❤

 

 

 

Do you think you can cure me?

A powerful post by Adrenal Alternatives Contributor: Michelle Barker who bravely battles incurable cancer along with adrenal insufficiency.

It’s happened to all of us. Even the non-chronically ill. Someone has suggested a sketchy miracle cure. Maybe they told you eating ‘healthy’ or going organic would have prevented or fixed your condition and will save you from taking your medications?

Why is this so frustrating? Their heart is in the right place is it not? What’s the problem?

When you tell me eating vegetables or a certain trendy food would prevent my condition, it insinuates that my choices have caused my condition and all of the resulting health problems. That if only I had an organic farm and bought a juicer I’d be cancer and ‘pharma’ free.

My cancer is genetic. I could not prevent it, and all of the organic vegetables in the world will not cure it. That’s not really how cancer works. You can’t just throw ‘healthy stuff’ at cancer and make it go away. Individual cancers behave differently and the mechanisms of their growth and death need to be understood on the cellular level for best treatment. No amount of kelp will do that.

Of course, a healthy lifestyle is a benefit to anyone with or without a medical condition, but should not be used in place of treatment. Many of the miracle stories you read about conveniently leave out the part where their “natural miracle cure” also involved some surgery, chemo, and/or radiation. That doesn’t get as many facebook likes now does it? These stories are dangerous misinformation. Please stop sharing them.

Next, can we please stop judging people who have to take medications?

This implies I’ve failed some how because my life depends on medication. I would so love to toss all of my pills into the trash. That would be a dream, but guess what? I’d die. I’d suffer greatly, and die shortly thereafter. I cannot trade my medications for coconut oil or anything else on a grocery store shelf (or farm.) Maybe I am a slave to ‘big pharma.’ I like living though. I’ve got a family, so I’ll keep taking my meds and keep living as long as I can. For me, that means meds forever, and I’m okay with that.

I value and protect my health. I do appreciate your concern for me. Cancer isn’t fun, adrenal disease isn’t either and I know you want to help.

I want there to be a miracle cure too, but rather than cling to false hope, I will keep using treatments that are proven effective. I’d rather not hear any more cures. Instead let’s talk about enjoying life, savoring the moment. That’s the real way you “beat cancer.” One breath, one day at a time.