Myths about the Cortisol Pump


Myth #1 “It is not available.”

The cortisol pumping method is a relatively unknown alternative treatment for adrenal insufficiency. Most doctors have never heard of it, but that does not mean it is not available. The use of infusion pumps to deliver medication is a common practice, mainly in the management of diabetes. However, the use of cortisol in infusion pumps is considered “off label” use. Cortisol pumping is available wherever infusion pumps are available. All you need is a doctor willing to manage your care, which involves he or she writing a prescription for an infusion pump, supplies and solu-cortef. Adrenal Alternatives Foundation works with patients internationally with cortisol pumping advocacy and we educate healthcare professionals all over the world on how to safely and effectively start the cortisol pumping method. We also work alongside other organizations to repurpose pumps and supplies to adrenal patients with our Pumps for Purpose program. Cortisol pumping is available internationally, wherever infusion pumps are available.

Myth #2 “It isn’t safe.”

Research has shown that cortisol pumping is an effective alternative treatment to oral steroids for the management of cortisol deficiency. We have compiled a comprehensive list of evidence showing that this method is safe.

A recent poll done by Adrenal Alternatives Foundation revealed that 97% of the patients surveyed stated that cortisol pumping improved their quality of life.

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 cortisol pumping method 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.

Myth #3 “My insurance won’t cover it”

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.

Our foundation team also assists patients file insurance appeals has successfully battled countless insurance companies across the nation and can assist you in your fight for coverage.

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

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.

Myth #4 “My doctor said no.”

Finding a healthcare professional willing to work with this relatively unknown treatment option can be a challenge. You may have to “query” multiple physicians before you find one willing to manage your care on the cortisol pumping method.

In order to achieve this, it is best to prepare a compelling case and provide it to the physician before your appointment. Send research on the cortisol pumping method and your health records to the physician before your appointment so they are aware of your intentions before hand. We have created a pump proposal letter you can fill out with your information, explaining your diagnosis, failed treatments and desire to be on the pump. The doctor may or may not be receptive to your request and alerting them of your intentions beforehand may save you time, money and effort. Again, you may have to contact multiple physicians before finding one who is willing to manage the cortisol pumping method.

Our clinical team is also willing to speak with your current physician and provide them with guidelines on how to safely start the pumping method. If you would like our assistance, fill out our contact form and request a cortisol pumping consult.

Myth #5 “It isn’t legal.”

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 an “off label” treatment. 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.  

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.

You can also listen to our podcast episode Everything you need to know about the Cortisol Pump! or download our Guide to the Cortisol Pump.

This information was brought to you by the Adrenal Alternatives Foundation for educational use only and is not meant to provide medical care or advice.

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

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What is the difference between blood, urine and saliva cortisol testing?

What is the difference between blood, urine and saliva cortisol testing?

*This information is to be used for educational purposes only and is not intended to provide medical care or advice*

There are three forms of cortisol in the body:

1.Free cortisol

2.Bound cortisol

3.Cortisol metabolites

Bound Cortisol– Cortisol which is attached to a specific protein (CBG) is known as a bound cortisol. Metabolized cortisol evaluates how much cortisol is being made in total and cleared through the liver.

Free Cortisol- Cortisol which is not attached to any protein known as free cortisol. Free cortisol reveals how much cortisol is free to bind to receptors and allows for assessment of the circadian rhythm.

Cortisol metabolites– Metabolites of cortisol gives insight into the relative activity of 11b-HSD types I and II, which controls the activation and inactivation (to cortisone) of cortisol.

Approximately 90% of cortisol is bound to cortisol-binding globulin (CBG), also known as transcortin, and albumin.  Transcortin: corticosteroid-binding globulin (CBG) or serpin A6, is a protein encoded by the SERPINA6 gene and is an alpha-globulin. Albumin: main protein in your blood and carries substances such as hormones, vitamins, and enzymes throughout the body.

5% of circulating cortisol is free (unbound). Only free cortisol can access the enzyme transporters in the liver, kidney, and other tissues that mediate metabolic and excretory clearance.

Cortisol-binding globulin (CBG) has a low capacity and high affinity for cortisol, whereas albumin has a high capacity and low affinity for binding cortisol. Variations in CBG and serum albumin due to renal or liver disease may have a major impact on free cortisol.

Standard Ranges for Cortisol:

A normal adult range for cortisol levels in urine is between 3.5 and 45 micrograms per 24 hours.

Reference ranges for salivary cortisol assay: <0.4–3.6 nmol/L at 2300 h & 4.7–32.0 nmol/L at 0700 h.

Standard 8 a.m. range for blood serum cortisol is between 6 and 23 micrograms per deciliter (mcg/dL)

Measuring both free and bound cortisol levels allows for insight into the rate of cortisol clearance/metabolism and clearance.

Urine and saliva cortisol testing are used to evaluate free cortisol levels. Morning saliva cortisol panels are done to measure the diurnal cortisol curve. Blood cortisol testing is used to evaluate total cortisol and also bound cortisol.

In patients with adrenal insufficiency, an evaluation of cortisol tested via blood, saliva and urine can all be beneficial in evaluating the efficacy of their cortisol replacement medication(s). Recommended protocols are a comparative assay of cortisol levels from urine, blood and saliva specimens. The patient’s quality of life, symptomatic complaints and also fatigue levels should also be used when evaluating a proper cortisol dosing regimen.

Sources:

Abraham, S. B., Rubino, D., Sinaii, N., Ramsey, S., & Nieman, L. K. (2013). Cortisol, obesity and the metabolic syndrome: A cross-sectional study of obese subjects and review of the literature. Obesity (Silver Spring), 21(1), 1-24. doi:10.1002/oby.20083

Dhillo WS, Kong WM, Le Roux CW, Alaghband-Zadeh J, Jones J, Carter G, Mendoza N, Meeran K and O’Shea D. Cortisol-binding globulin is important in the interpretation of dynamic tests of the hypothalamic-pituitary-adrenal axis. Euro J Endo. 2002;146

Hoshiro, M., Ohno, Y., Masaki, H., Iwase, H., & Aoki, N. (2006). Comprehensive Study of Urinary Cortisol Metabolites in Hyperthyroid and Hypothyroid Patients. Clinical Endocrinology, 64, 37-45. doi:10.1111/j.1365-2265.2005.02412.x

Taniyama, M., Honma, K., & Ban, Y. (1993). Urinary Cortisol Metabolites in the Assessment of peripheral Thyroid Hormone Action for Diagnosis of Resistance to Thyroid Hormone. Thyroid, 3, 229-233.

Tomlinson, J. W., Finney, J., Hughes, B. A., Hughes, S. V., & Stewart, P. M. (June 2008). Reducing Glucocorticoid Production Rate, Decreased 5alpha-Reductase Activity, and Adipose Tissue Insulin Sensitization After Weight Loss. Diabetes, 57, 1536-1543.

Bancos I, Erickson D, Bryant S, et al: Performance of free versus total cortisol following cosyntropin stimulation testing in an outpatient setting. Endocr Pract 2015 Dec;21(12):1353-1363 doi: 10.4158/EP15820

Petersen KE: ACTH in normal children and children with pituitary and adrenal diseases. I. Measurement in plasma by radioimmunoassay-basal values. Acta Paediatr Scand 1981;70:341-345

Hamrahian AH, Oseni TS, Arafah BM: Measurements of serum free cortisol in critically ill patients. N Engl J Med 2004;350;16:1629-1638

Ho JT, Al-Musalhi H, Chapman MJ, et al: Septic shock and sepsis: a comparison of total and free plasma cortisol levels. J Clin Endocrinol Metab 2006;91:105-114

le Roux CW, Chapman GA, Kong WM, et al: Free cortisol index is better than serum total cortisol in determining hypothalamic-pituitary-adrenal status in patients undergoing surgery. J Clin Endocrinol Metab 2003;88:2045-2048

Huang W, Kalhorn TF, Baillie M, et al: Determination of free and total cortisol in plasma and urine by liquid chromatography-tandem mass spectrometry. Ther Drug Monit 2007;29(2):215-224

Mayo Clinic Laboratories-  https://www.mayocliniclabs.com/test-catalog/Clinical+and+Interpretive/65484

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

EIN: 83-3629121.

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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/

What is the Cortisol Pump?

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What is the cortisol pump?

Basically, the cortisol pump is a repurposed insulin pump that delivers solu-cortef instead of insulin.

The use of solu-cortef (injectable version of cortisol when mixed with saline) is placed in an insulin pump that is programmed to disperse cortisol according to circadian rhythm dosing by programming rates of basal delivery into the pump. The pump also has options to bolus for stress dosing.

This helps adrenal patients maintain better control of their cortisol levels by allowing them to get cortisol quicker instead of waiting until steroid pills metabolize through the stomach and finally enter the bloodstream.

This therapy bypasses the gastric system and is able to deliver cortisol in a more consistent way. With a pump, an adrenal insufficient patient can receive a constant supply of cortisol and will not suffer the ups and downs with oral cortisol replacement tablets. They are able to sleep through the night without having to wake up to take steroid pills.

This can be of great benefit to adrenal patients who are hypermetabolizers of cortisol. Some patients have to take medications more frequently than others due to their body’s high cortisol clearance rate. The pump is a great asset to these patients because they are no longer forced to take pills every couple of hours around the clock.

Side effects due to mal-absorption can be decreased and patients have been reported to have improved sleep, weight management, gastric issues and experience an overall improvement in their energy levels and sense of well-being as opposed to taking steroid tablets.

Professor Hindmarsh, of CAHISUS is a pioneer for this life changing treatment.

For more information on the medical information visit his website-http://www.cahisus.co.uk/pdf/USING%20THE%20PUMP%20METHOD%20IN%20ADDISON%27S.pdf

The pump is not a cure for adrenal disease and is difficult to obtain. This treatment is relatively an unknown in the United States and this foundation is actively working to raise awareness on this alternative treatment to managing adrenal insufficiency.

It is a difficult process but it IS POSSIBLE!  For more information please read our article on HOW TO GET ON THE CORTISOL PUMP.

If you feel you could benefit from the cortisol pump, speak with your endocrinologist but be prepared to hear “NO.”

Don’t lose heart!

There are doctors in the USA who will manage this treatment and we hope to continue raising awareness so that one day it will be as available to adrenal patients as it is to diabetics.

We’re here to lead all adrenal patients to every adrenal alternative!

 

 

 

 

 

Adrenal Awareness Care Package Program

We are so excited to announce the Adrenal Awareness Care Package Program!

The Adrenal Awareness Care Package program is run by the Adrenal Alternatives Foundation and provides adrenal patients with comforting products and supplies as well as encouraging and educational resources to improve their lives as they fight this devastating disease.

To qualify, you must live in the United States and have been diagnosed with an adrenal disease.

(We hope to branch out to be able to ship care packages internationally at some point but for now only can ship in to the USA due to costs)

Applications will be considered by the Foundation.

Our Care Package program will begin taking applications now through April of 2019 and we will begin our package distribution in the summer of 2019.

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Applications for the following year will be accepted again in January of 2020.

To apply, please fill out the application at the link below.

https://docs.google.com/forms/d/e/1FAIpQLScgu4TctP0LcrqEu4KQKU-krHAG7wPehABGgqCXTJ8h79RCcw/viewform?usp=sf_link

Wishing you all comfort and cortisol,

The Adrenal Alternatives Foundation