Upcoming Adrenal Technology- Twistject Cortisol Delivery Device Update

Adrenal Alternatives Foundation is a proud affiliate of SOLUtion medical, which is a company creating an auto-injecting device to deliver the life saving cortisol injection.

We were privileged to interview SOLUtion’s founder, Julia Anthony on the latest updates for the TWISTject device!

  1. Please introduce yourself. 

Julia Anthony, Chief Executive Officer of SOLUtion Medical. 

  1. What form of adrenal disease were you diagnosed with?

I was diagnosed with Salt-Wasting Congenital Adrenal Hyperplasia (SWCAH) at birth. This is a rare, chronic, autosomal recessive genetic condition requiring daily medication for the rest of my life, and rescue injection during an adrenal crisis. 

  1. Can you tell us about SOLUtion medical?

SOLUtion Medical is developing a one-step injector for delivering adrenal crisis medication in a rescue situation. With our device we plan to eliminate the need for cumbersome and confusing rescue kits, and replace those kits with a single, one-step device.

  1. What updates can you tell us about upcoming developments for the TwistJect device?

Our device automatically mixes medication without requiring shaking or visual monitoring. Initial data shows our product mixes hydrocortisone sodium succinate powder approximately 20X faster than the current standard of care in only one user step. We are presently working to optimize our product for manufacturing. 

Our immediate goals are to complete the design process to define how our device will be manufactured in medically compliant manufacturing, a non-trivial process. We expect to obtain approvals throughout the world so our device can be obtained by anyone at risk of an adrenal crisis regardless of location.   

Longer term, we envision our device as applicable to many different drugs and treatments, allowing more at-home usage of a variety of medications requiring mixing directly prior to injection. 

  1. How will your invention change the future of adrenal crisis management?

By simplifying rescue injections, more sufferers of adrenal insufficiency will be empowered to carry and use their rescue medication. This will reduce mental burden, increase compliance, and improve the lives of those with adrenal insufficiency.

  1. What goals do you hope to accomplish with your work?

Virtually everyone at risk for an adrenal crisis must carry a rescue kit, and these kits are not straightforward or easy to use. As a result, too few people inject themselves with rescue medication at the onset of an adrenal crisis, resulting in longer hospital stays, lower quality of life, and even death. A simple, easy to use device will reduce complexity and difficulties of injections, providing an “EpiPen” like experience that is intended to improve compliance of rescue injections during an adrenal crisis. 

  1. What is the timeline for the availability of the TwistJect device?

Developing and obtaining regulatory approvals for a drug device combinatorial product can be a long process.  We are targeting late 2024 for product launch, with hopes of delivering the device sooner. Much depends on the time spent during the regulatory approval process. 

  1. How complex of a project is the creation of your device from concept to production?

It is fairly complex, especially because our product is a combinatorial product, meaning it combines two regulated components, the rescue drug and the drug delivery device. Manufacturing, testing, documentation, and other regulatory compliance add multiple layers of complexity on top of normal manufacturing adding to both time and cost. These processes are all individually understood, but combining them into a product such as this is certainly non-trivial.

  1. What is something you want to tell the adrenal community?

You and your voice matter. Use it – for yourself and to empower others in the adrenal and rare disease communities. 

  1. How do you balance work and living with adrenal disease?

The forever present and typically invisible (when well-managed) chronic condition that is SWCAH makes work-life balance – an already challenging equilibrium – even more difficult. I am lucky to be surrounded by a talented and passionate team who are understanding of my condition and its affects. At the end of the day, it is thinking about the individuals and families we aim to help through our work that keeps me going. 

For more information on SOLUtion medical you can visit their website: https://solutionmedllc.com/

The Adrenal Alternatives Foundation is registered with the IRS as a 501(c)3 nonprofit organization.

EIN: 83-3629121.

The Cortisol Pump Saved my Life

This is what undiagnosed adrenal insufficiency looks like.

I was 96lbs at 5’4. My hair was falling out. I was fatigued. I struggled to breathe. My anxiety and mental health was slipping. I was 22 years old, dying and I knew it…….but I had no idea why…….

Notice the sea salt in the background?

I was craving it and eating it like candy.

I went to countless doctors, specialists and medical professionals, who never could find any answers.

Then, tragedy struck, I had an adrenal crisis on my 23rd birthday. Below is the lab result from my blood cortisol level test. After this result, I was transferred to Cleveland Clinic Florida, where they administered an ACTH Stim test, which I epically failed. I was then diagnosed with primary Addison’s disease and started on hydrocortisone and fludrocortisone.

After my adrenal crisis, my life was never the same. I struggled to stabilize on the oral steroid tablets due to malabsorption issues stemming from my congenital disorder, Medullary Sponge Kidney. My weight went up and my quality of life went down.

Research shows that adrenal disease patients diagnosed after an adrenal crisis are statistically less stable than those who are diagnosed never having an adrenal crisis.

This was definitely the case for me. I watched my life crumble. After my adrenal crisis, I suffered central nervous system damage and not only was unable to work, but also struggled to put pants on, hold a spoon and ever shower myself.

I was only 23 years old, facing a bedridden reality where I had to face my own mortality. I went to doctor after doctor, just hoping for a miracle, to no avail.

I was determined to get my life back, so I began obsessively searching for ways to improve my health. I was fortunate to come across Professor Hindmarsh’s book, Congenital Adrenal Hyperplasia where he mentioned the cortisol pumping method.

I knew this method was my best chance at stabilizing with my adrenal insufficiency. Over the next two years, I pursued this treatment. I visited countless endocrinologists in hopes that they would write my prescriptions for the pump, the medication (solu-cortef) and the supplies to begin cortisol pumping, again, to no avail. I was met with the answer of NO on every occasion, citing the reason “adrenal disease is just not managed that way” or “It’s not FDA approved.”

After two years, I finally found a local nurse practitioner who was willing to write the necessary prescriptions. Victory, finally….

……..or so I thought.

I quickly discovered how difficult it was to obtain insurance coverage for an infusion pump if you are not diabetic. Even though I had FINALLY found a doctor willing ti write the prescriptions, my insurance not only denied the pump and the supplies, but also denied the solu-cortef medication as well.

I appealed the decision from the insurance company and continued to fight to start the cortisol pumping method. Florida Blue never approved my request.

It amazed me to see how difficult it was to start the cortisol pumping method. There were so many obstacles to overcome. It was then I realized that there was a massive deficit in the world and I was going to do all it took to fill that deficit, not only for myself but for every adrenal disease patient suffering as I was.

That was the day Adrenal Alternatives Foundation was born.

No longer will we have to scope out ebay, craigslist and internet sources for infusion pumps or supplies. No longer can doctors tell us this method isn’t possible. No longer will anyone have to feel insane for attempting a new method to manage their cortisol replacement.

Adrenal Alternatives Foundation is proud to have a clinical team eager to direct adrenal patients, families and physicians to all possible options to manage adrenal insufficiency.

We are also pleased to be aligned with the organization CR3 to provide pumps and supplies to adrenal patients need them; with or without insurance coverage.

The cortisol pumping method saved my life. Though it is not a cure for adrenal insufficiency, it is allowing me to live my life in a way that was not possible on cortisol tablets.

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Click HERE for more information on cortisol pumping.

You can also read more about managing adrenal disease in the book, Adrenal Insufficiency 101, Patient’s Guide to Managing Adrenal Insufficiency.

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.
EIN: 83-3629121.

We appreciate all contributions which allow us to further our mission, Education, Advocacy and Awareness for all adrenal disease.

Donate to Adrenal Alternatives Foundation

Special thanks to NP Photography for sponsoring our Adrenal Awareness Photography Session.

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.
EIN: 83-3629121.

We appreciate all contributions which allow us to further our mission, Education, Advocacy and Awareness for all adrenal disease.

Donate to Adrenal Alternatives Foundation

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?

donateblood (2)

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

 

Is hyperbaric oxygen therapy safe with adrenal disease?

Hyperbaric oxygen therapy is an alternative treatment used to promote healing. With this treatment, a patient is placed in a hyperbaric oxygen therapy chamber, in which the air pressure is increased to higher than normal air pressure so that the patient’s lungs can absorb more oxygen.
The pressurized oxygen expelled within the chamber is believed to help your blood carry more oxygen and therefore promote healing and wellness.
Hyperbaric oxygen therapy increases the amount of oxygen the blood can carry. It is believed this increase in blood oxygen temporarily restores normal levels of blood gases and allows tissue function to promote healing and fight infections.

Hyperbaric oxygen therapy is considered a generally safe procedure, but this treatment does carry risks for adrenal disease patients.

It is important to thoroughly research any treatment, medication or alternative therapy and discuss it with your doctor before you begin any new regiment.

It is the objective of the Adrenal Alternatives Foundation to educate all adrenal patients on the risks and benefits of all possible treatments. Upon our research, we discovered the risks of hyperbaric oxygen therapy as it pertains to adrenal insufficiency. Below are a few extracts from two studies that address these concerns. Further reading/studies are in the sources at the end of this post.

(NOTE- There is no cure for adrenal insufficiency, except in the cases of steroid induced adrenal suppression. Never discontinue your steroid medication. Any alternative treatment/medication/therapy that claims to cure adrenal insufficiency is false.)

oxygen (2)

Abstract of the Undersea & Hyperbaric Medical Society 2008 Annual Scientific Meeting June 26-28, 2008 Salt Lake City Marriott Downtown, Salt Lake City, Utah.

RESULTS: The attendant with Addison’s disease was found to have a drop from a morning level of 16.5 ug/dl to a critical level of 1.4 ug/dl. Subsequent testing without HBOT showed a lesser, non-critical drop of 29.1ug/dl to 9 ug/dl (normal range for the circadian cycle).

US National Library of Medicine National Institutes of Health – Effect of hyperbaric conditions on plasma stress hormone levels. Department of Anesthesiology, Turku University Hospital, Finland.

Cortisol levels decreased significantly (P = 0.001) during the treatments. No significant changes were found in other analyzed hormones.

It is important to be aware that hyperbaric oxygen therapy has been shown to decrease serum cortisol levels, therefore making this treatment a concern for those with adrenal disease.

Discuss any treatments, alternative therapies and medications with your doctor before trying any new regiment.

If you are a cortisol pump user, you will not be able to have your pump within the hyperbaric chamber to administer your cortisol. Due to the high oxygen concentration, any battery operated devices are a fire concern.

If you are considering any alternative therapies, please research them thoroughly and discuss them with your doctor before you begin any medication, treatment or regiment.

Sources:

https://www.ncbi.nlm.nih.gov/pubmed/10372427

http://archive.rubicon-foundation.org/xmlui/handle/123456789/7867

https://www.todayswoundclinic.com/articles/oxygen-wound-healing-going-beyond-hyperbaric-therapy

https://www.mayoclinic.org/tests-procedures/hyperbaric-oxygen-therapy/about/pac-20394380

The Crucial Role of Oxygen for Health

https://www.ncbi.nlm.nih.gov/pubmed/20737929

How does Hyperbaric Oxygen Therapy (HBOT) help with Stress?

https://www.canr.msu.edu/news/understanding_cortisol_the_stress_hormone

https://www.todayswoundclinic.com/articles/oxygen-wound-healing-going-beyond-hyperbaric-therapy