Dear VSI Members, Friends, and Donors,

As I’m writing this message, COVID-19 news is changing minute-by-minute. There is very little I could tell you that you won’t already know by the time you read this.

While the emergency travel, crowd, and retail restrictions are alarming, the thing to remember is that they are being implemented in an effort to curb the spread of disease. As I told my children, “These measures are being taken not because the sky is falling, but to prevent the sky from falling.”

If the coronavirus germs looked big and scary – like a 6 inch spider floating through the atmosphere, landing on counter tops and doorknobs, they would be easy to recognize and avoid. However, not only is that is not the case, but the outward signs of illness that we’ve long associated with a person spreading germs, such as a runny nose, cough, fever etc., are kind of like the 6 inch spider. Even if the germs of those outwardly ill looked like those 6 inch spiders, and you were able to avoid them, we are now learning that there may be an even greater invisible risk.

Dr. Sandra Ciesek, director of the Institute of Medical Virology in Frankfurt, Germany, recently tested 24 passengers who had just flown in from Israel. Seven of the 24 passengers tested positive for coronavirus. Four of those were asymptomatic (had no symtoms) and Ciesek was surprised to find that the viral load of the specimens from the asymptomatic patients was higher than the viral load of the specimens from the three patients who did have symptoms. Viral load is a measure of the concetration of the virus in someone's respiratory secretions. A higher load means that someone is more likely to spread the infection to other people. Source: Elizabeth Cohen, Senior Medical Sorrespondent, CNN Health

The incubation period, the time between being exposed to the germ and when a person actually begins to exhibit symptoms, can range from 2 – 14 days. Consequently, a person can be contagious (carrying and shedding the germ) long before symptoms begin. And now, it seems, we are learning that the germs of those exposed but not yet showing symptoms, are potentially like a 9 inch invisible spider!

Another enigma to this ongoing story is the role that children may be playing in this epidemic. As of the time this is being written, for some reason, children under the age of 10 years comprise only around 1% of those infected. And the great majority of those children who have contracted COVID-19 have had very mild cases.

Some experts hypothesize that many more children have actually had COVID-19, but remain undiagnosed because they were either asymptomatic or their symptoms were so mild that they went unrecognized as anything other than a common cold. However, children are thought to be hidden carriers, hence closing schools to further curtail spread to the rest of their communities.

What does all of this mean to those with vitiligo?

Having vitiligo, in and of itself, does not place a person in a separate risk category. Each person with vitiligo is unique with regard to their own pre-existing conditions and risk factors.

Consequently, those with vitiligo would follow the same government guidelines as they relate to your personal health, lifestyle, and circumstances.

For additional information on vitiligo and COVID-19, Click Here.

Sincerely,

Jackie Gardner
Executive Director

Organization and Campaign Update

2020 American Academy of Dermatology (AAD) Anual Meeting

Many of you may recall that each year at this time, I attend the AAD annual meeting. This meeting brings together 15 to 20 thousand attendees including dermatologists and researchers from around the world who report their most recent treatment and research findings. Attending these meetings is how VSI stays apprised of all the most current information, and in turn, disseminates that to our members. Unfortunately, as you may have guessed, this year’s meeting scheduled to be held in Denver CO. was cancelled due to COVID-19. They are in the process of exploring virtual meeting options along with other methods of distributing the “research, knowledge, and expert insight from the meeting.” Hopefully, the vitiligo presentations will be made available in some manner later this spring.

First Ever FDA Planned “Patient-Focused Drug Development Meeting for Vitiligo

You may have seen VSI’s social media and Community Page announcements regarding the patient-focused FDA meeting for vitiligo scheduled to be held March 30 in Silver Spring, MD. The purpose was to personally connect FDA members, and a wide representation of medical and industry professionals with vitiligo patients and caregivers, and to learn about the impact on daily lives, as well as to hear thoughts on treatments and managing vitiligo. The program included provisions for those unable to attend to participate live via webcast. Unfortunately, this meeting has been postponed until a later date. VSI will post updates as we receive them. If you would like to receive a notification when the event is rescheduled, click here.

VSI Funding Campaign

Over a year ago, VSI set a goal to raise $100,000 by the end of the year, to hire additional support staff to enable VSI to meet the growing demands on the organization, maintain current programs and services, and cover projected specialized IT and website expenses.

As of our January Newsletter update, we’d received nearly 70% of that goal. As is so often the case with nonprofit organizations, donations ebb and wane throughout the year, peaking with the end-of-year/holiday campaigns, then dropping off. This seems to be the curve VSI is following. We’ve received only $5,800 since our last report in January.

Recurring Donation Report

Recurring/Monthly gifts provide a steady stream of funding, allowing for planning.
We now have a total of 34 monthly donors, bringing in around $600 a month!

We’d like to welcome our two new recurring donors:
Clay Fuller
Carrie Huestis

We’ve processed 34 Supporting Memberships since the last newsletters.
Of those, the following are first-time donors!

It's Make or Break Time

The coming months are critical to the ultimate success or failure of this campaign. When assessing our capacity to move ahead with the hiring process, we have to take into account our ability to cover ongoing organizational expenses and potential rainy-day needs, as well as both the direct and indirect costs associated with adding new staff, such as the down-time of current staff required for training, in addition to the learning curve prior to productivity of the new hire.

Adding year-end preparations to an already busy schedule, the 4th quarter for any non-profit is unquestionably the very busiest. Consequently, incoming funding in the next 3 or 4 months will likely determine whether critically needed staffing assistance becomes a reality in 2020, or has to wait another year. If the latter is the case, we will once again be placed in a position of assessing which services and resources to cut.

The time is now.
The choice is yours.

If you’ve not yet contributed, it’s most definitely not too late! If you’ve already contributed but feel led to increase your support, I cannot stress enough that each and every donation, large or small, makes a difference.

Fatigue and Autoimmune Disease

Because the most common type of vitiligo, non-segmental vitiligo (also known as generalized vitiligo), is an autoimmune disease, VSI has written a number of articles over the years on the topic of vitiligo and autoimmunity.

We know from genetic research that multiple genes linked with vitiligo are also associated with other autoimmune disorders, indicating that those with vitiligo, as well as their close relatives, have an increased risk of developing other autoimmune diseases.

As shown in the above diagram, vitiligo has been found to share genes with a number of autoimmune diseases (A/D), including Addison’s disease, celiac disease, Crohn’s disease, discoid lupus, Graves’ disease, Guillain Barre, Hashimoto’s thyroiditis, inflammatory bowel disease (IBD), linear morphea, multiple sclerosis, myasthenia gravis, pernicious anemia, psoriasis, rheumatoid arthritis (RA), Sjögren’s syndrome, systemic lupus erythematosus (SLE), systemic scleroderma, and type 1 diabetes, as well as others.

Autoimmune thyroid disease (AITD), (Hashimoto’s and Graves) is the most prevalent. The risk for those with vitiligo of developing AITD has been found to be 2.5 times higher than in the normal population, and this risk increases with age.

Autoimmune Disease and Fatigue

Although vitiligo itself is not necessarily associated with fatigue, it is an inflammatory autoimmune disease, and research indicates that inflammation plays a prominent role in inducing fatigue because the body becomes drained from directing resources to combat the immune response. Fatigue is at the top of the list of side-effects for all of the A/D associated with vitiligo.

According to the recent article, Fatigue, Sleep, and Autoimmune and Related Disorders, “profound and debilitating fatigue is the most common complaint reported among individuals with autoimmune disease.” With the possibility of those with vitiligo and/or their family members acquiring one or more other A/D, we felt the following information would be of interest.

Chronic fatigue is far more than just feeling sleepy. Autoimmune fatigue causes feelings of exhaustion that do not improve with rest. Even sleeping all day doesn’t seem to help. Other side effects of fatigue may include headaches, “brain fog” or an inability to concentrate, or difficulty maintaining stamina for simple everyday activities such as doing a load of laundry or walking up a flight of steps. Click here to read on: Fatigue—What is it? Why is it?

Tips to Improve Fatigue

Stay active! Too little activity can make fatigue worse. Don’t fall victim to not exercising due to low energy. This can create a vicious cycle. A mid-afternoon nap may help, but staying in bed all day only feeds fatigue. Try to establish a physical activity program and stick with it.

Improve your Nutrition. Food is your body’s source of energy. Diet can play a significant role in fatigue, particularly one high in empty calories from junk food, fatty foods, and refined sugar. Attempt to eat 3 balanced meals each day.

Identify the Source of your Fatigue

There are reasons for fatigue that can be addressed to ameliorate the symptoms.

Chronic Inflammation:

There are blood tests your health care provider (HCP) can order to assess your level of inflammation:
CRP (C-reactive protein) and ESR (Erythrocyte sedimentation rate)
If inflammation is found to be the cause, reducing your sugar intake and eating whole, unprocessed foods can help decrease inflammation.

Medications:

Fatigue is a common side effect of several medications used for autoimmunity. If this is the case, discuss alternatives with your HCP.

Anemia: There are multiple types of anemia.

Anemia from chronic inflammatory, infectious, or autoimmune diseases.
Supportive nutrition and lifestyle changes to reduce stress can help reduce these symptoms.

Iron deficiency anemia.
Consult your HCP about a ferritin (iron deficiency) test

Discuss foods and supplements high in iron to help increase iron with your HCP

Pernicious anemia:

This autoimmune disease, among those associated with vitiligo, is caused by the inability to absorb vitamin B-12, resulting in a deficiency.

Discuss testing with your HCP for a definitive diagnosis.

Your HCP may suggest foods and supplements rich in B-12 and folic acid.

Depression:

Up to 1/3 of those living with a chronic illness experience some level of depression at some point. Living with a chronic illness can cause many life changes and erode self-confidence, leading to isolation and feelings of sadness and despair. The risk of depression increases with the level of life disruption, and especially for anyone with a personal or family history of depression. The stress and anxiety experienced with depression not only causes fatigue, but can actually make the condition worse.

Living with a chronic illness is challenging. It’s normal to experience feelings of sadness as you begin to adapt to the new reality. But if these feelings persist, or lead to loss of appetite and/or trouble sleeping, or you find you no longer enjoy or want to participate in activities you once enjoyed, it’s time to seek help.

Tips to Avoid Depression:

Try not to isolate yourself. Try to establish a solid support system.

Ask your HCP about support groups.

Try to maintain the friends and activities you used to enjoy. Staying connected improves self-confidence.

Educate yourself about your condition. Learning about the disease and treatments helps to regain a sense of control.

If you are experiencing symptoms of sadness and depression that you are unable to control, do not wait to get help. Seek a therapist of counselor.

Early diagnosis and treatment are key to overall well-being and improvement.

Stress and adrenal fatigue:

Your adrenal glands produce a stress hormone called cortisol, which plays an important role in a number of your body’s functions. Under normal circumstances, cortisol helps to manage how your body uses carbohydrates, fats and proteins. It also helps keep inflammation down, regulates blood pressure, and helps control your sleep/wake cycles.

Normal cortisol levels peak in the early morning serving as a built in alarm clock, and are at their lowest levels around midnight, allowing the body to wind down and go to sleep. Cortisol also rises after meals and most noticeably in stressful situations, producing what is known as the “fight or flight” response.

Typically once a stressful situation resolves, cortisol levels return to normal. However, in the situation of long-term chronic stress, the body continues over-producing this hormone. Because cortisol inhibits insulin production, elevated levels can result in blood sugar imbalance, diabetes, and chronic fatigue, as well as thyroid disorders. In time, the adrenals are no longer capable of producing sufficient levels of cortisol, resulting in a perpetual state of exhaustion.

Stress management is key to controlling cortisol levels.
Click here for additional information on stress management

A low-inflammatory, well-balanced diet, low in refined sugar, high in protein, with fresh vegetables and whole grains has been recommended as “adrenal-friendly.”

A healthy adrenal fatigue diet includes:

Lean meat, fish, eggs, nuts, leafy greens and colorful vegetables, whole grains, dairy, low-sugar fruits, sea salt in moderation, and healthy fats such as olive oil, coconut oil, and grapeseed oil.

Some foods to avoid or limit include:

White sugar, white flour, alcohol, caffeine, soda, fried food, processed food, fast food, and artificial sweeteners.

Closing

Identifying the source of fatigue is not always easy, and there may be more than one cause. Know your limits and give yourself permission to take time to heal. Chronic fatigue is very real and not a sign of laziness or lack of motivation. Try to look at the whole picture, working with your HCP to make improvements in as many areas as possible.

The above article is not meant to provide medical advice, diagnosis or treatment, or intended to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

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Calling all Medicare Vitiligo Patients!

VSI regularly hears from patients from all over the United States who have been denied insurance coverage for their vitiligo treatment. VSI has been fighting this battle on a national level for several years. While we are definitely making progress, it’s been a slow road.

Part of the problem is that currently there is no accepted standard for coverage of vitiligo treatments. Each company has their own policies and guidelines, many times based on outdated and incorrect information.

What most people may not realize is just how much private insurance coverage can be affected by Medicare policies. Over 55 million Americans are now covered by Medicare or Medicare Advantage, making it the nation’s largest health insurance program. Consequently, many, if not most, insurance providers establish their baseline standards and procedures to follow the Medicare model.

Medicare has agreed to meet with us – but requires that we bring Medicare letters of denial for a vitiligo treatment.

If you are reading this newsletter and you, or someone you know, was denied coverage for a vitiligo treatment by Medicare, please contact VSI immediately. You could help make a difference for future insurance coverage for ALL vitiligo patients! Click Here to Contact VSI

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What's On Your Mind?

Q. Should I Buy a Used Narrowband UVB (NB-UVB) Light Unit?

VSI frequently hears from members who for various reasons are no longer using their home light units and are seeking information on re-selling or donating. We also receive questions from those considering purchasing either a second-hand light unit or a unit they’ve found online.

1. If you are looking to buy a light unit for home use, new or used, there are some things you need to know.

First, you will need a prescription.

In the United States, where VSI is incorporated and operates, the U.S. Food and Drug Administration (FDA) under Section 201 (h) of the Federal Food, Drug and Cosmetics Act, classifies ultraviolet light units for treating dermatological diseases as “medical devices.” As such, the U.S. Code of Federal Regulations Title 21, section 801.109 requires a doctor’s prescription to buy (or in any way obtain) a home phototherapeutic device.

Second, it is against the U.S. law for an unlicensed
individual or company to sell a “medical device.”

U.S. Code of Federal Regulations Title 21, section 801.109 also states that it is illegal to sell, trade, or in any way distribute a phototherapeutic light unit unless legally licensed to do so by the FDA. Under the laws described above, only a physician or licensed light manufacturer or distributor is considered eligible to facilitate a sale or trade of a phototherapeutic light unit.

The point of requiring a prescription is to make sure that the patient is under the direction of a physician to ensure safe and effective use, and that the device purchased is fit for the intended purpose (disease).

Internet searches will frequently locate knock-off light units claiming to be legitimate medical devices. The problem with these units are that the lamps (bulbs) are likely counterfeit. They could be a simple fluorescent bulb or even a lamp intended to be used for warming reptile cages. You risk paying a substantial sum of money and receiving no benefit whatsoever, or worse, a serious burn.

It is important to know that the units and lamps you purchase are not counterfeit or made by companies not complying with the FDA regulations.

All phototherapy devices sold in the United States must have a US Food and Drug Administration (FDA) 510K clearance since federal law classifies them as Class II medical devices. The only personal exception that the FDA and U.S. Customs recognize as legal is when one purchases a machine outside the U.S. and hand-carries it back with a valid prescription from a physician.

Manufacturers are required by U.S. law to track the serial number of every device that they manufacture. The recall requirements of the Food and Drug Administration Good Manufacturing Practices (GMP) and European ISO regulations also require tracking of the serial or batch number of all critical components within the device, which includes the lamps.

Philips, a major producer of ultraviolet lamps, tracks every narrowband lamp they sell in the U.S. and links it to a doctor’s prescription. Because the FDA treats narrowband UVB, broadband UVB, and UVA lamps just as they do prescription drugs, Philips conducts “lifecyle tracking” by auditing prescription records from every entity that sells lamps or builds machines.

Legitimate U.S. companies spend thousands of dollars each year to remain in compliance with the FDA’s standards, which are in place to protect you, the consumer. The companies selling illegal products using illegal methods have not been subjected to these safety measures, so buyer beware!

The FDA provides a database where you can look up a
company to see if it is registered to sell medical devices in the U.S.

To check a specific company, scroll down and enter the company name as indicated.

Search by Company or Device Name

Medical News Updates

Highlights of recently-published medical
articles on vitiligo and its treatments

Comparison between Tacrolimus Ointment and Tacrolimus Combined
with Topical Pseudocatalase/Superoxide Dismutase Gel

Tacrolimus ointment, the generic form of Protopic (also known by Fujimycin, FK506, Prograf, Advagraf, Tacroz) is a topical immunosuppressant frequently used to treat vitiligo. It works by locally suppressing the immune response, by targeting the melanocytes.

Research has shown that those with vitiligo have increased levels of hydrogen peroxide (H₂ O₂) in the upper layers of the skin, causing oxidative stress. Most people produce an enzyme called catalase that breaks down H₂ O₂ preventing destructive over-accumulation. However, those with vitiligo do not produce enough catalase to counter the H₂ O₂, which is thought to contribute to depigmentation.

Pseudocatalase is a synthetic topical developed to simulate the effect of catalase when applied to the skin, thereby reducing the levels of H₂ O₂.

Superoxide dismutase is an enzyme that acts as an anti-inflammatory and antioxidant and is used to reduce inflammation and oxidative stress.

A vitiligo study just released from researchers in Jordan combined these two ingredients in a gel to make pseudocatalase/superoxide dismutase (PSD), and compared repigmentation results between two groups of children ages 2 – 18 with limited (less than 10% body surface area) vitiligo.

Group 1 (24 patients) applied Tacrolimus 0.1% ointment for 6 months. Group 2 (25 patients) applied Tacrolimus 0.1% ointment plus PSD.

The progress of both groups was assessed at 3, 6, and 9 months.
Group 1
23.9%, 40.4%, and 60%

Group 2
23.2%, 40.7%, and 62.4%

The researchers concluded that the addition of PSD was not of therapeutic benefit.

Tacrolimus Monotherapy for Vitiligo Treatment
vs
Tacrolimus + Microneedling

Microneedling has become increasingly popular in vitiligo treatment research. Not to be confused with Dermarolling, which can be carried out at home, microneedling is a professional procedure carried out by a physician, in-office. It uses a motorized pen with adjustable needle depth, which helps to prevent scarring.

Researchers in Egypt compared repigmentation results of 48 patients with vitiligo, randomized into two groups:

Group 1 applied topical tacrolimus once daily for 6 months.

Group 2 applied tacrolimus once daily, but also received microneedling at 2 week intervals for 6 months.

Results

Group 1 experienced 29.2% repigmentation.

Group 2 experienced > 75% in 50% of the patients, had an earlier response to treatment, and had significantly higher improvement on the legs and extremities.

Conclusion

The researchers reported that these results suggest the combination treatment was superior to the tacrolimus alone.

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Research & Clinical Trials

NEW Topical Jak Inhibitor Study
Tampa, Florida

Topical Jak Inhibitor Study
Brooklyn New York

Online Depigmentation Survey

Research Study in New York City

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