Dear VSI Members, Friends, and Donors,

I receive a number of daily medical updates from a variety of sources, and one recently caught my attention. The Dermatology Practice Update “Story of the Week,” titled “Availability of Prescription Medications for Sale Without a Prescription on the Internet in the US.”

The authors searched Google, Amazon, and eBay for prescription medications available for online purchase without a prescription. In spite of the fact that most online retailers have policies posted on their websites forbidding the sale of any substance requiring a prescription, there seems to be very little, if any, oversight or enforcement.

They ordered a wide variety of medications, some from within the USA, others from foreign countries. They did not have the products tested to verify authenticity, which leaves open the possibility of everything from incorrect amounts of the active ingredient, wrong active ingredient, or contaminants. However, of equal or greater concern was the omission of information regarding the potential risk of adverse reactions, especially drug-to-drug interactions.

The study abstract concluded with a note for the need of more comprehensive studies in the future,

and...

It was this final sentence that led me to reach out to one of the study authors, Dr. Fabrizio Galimberti, and explain the situation faced by so many vitiligo patients that leads to seeking underground treatment.

Vitiligo patients routinely (and historically) have had a great degree of difficulty finding physicians willing to prescribe current treatments. I could fill an entire page with the excuses we’ve heard from our members, but listed the most popular below.

Inaccessibility of prescription ingredients, such as the current international shortage of monobenzone, also creates barriers to treatment.

With so many obstacles, it’s no wonder so many vitiligo patients find themselves feeling abandoned and end up shopping online for treatments. Desperate times call for desperate measures.

Being one of the dermatologists who does in fact, routinely prescribe the most current treatments available for his vitiligo patients, Dr. Galimberti was shocked by the information I shared, and wanted to help. He mentioned the possibility of telehealth improving access to treatments for vitiligo patients.

Dr. Galimberti said that he and Dr. Romanelli Paolo, also on his dermatology team, are quite comfortable accessing the virtual telehealth platform to prescribe the full spectrum of treatments for vitiligo, including the most cutting edge therapies such as the JAK/Stat inhibitors.

As noted by the CDC, telehealth has been around for a while, but not well accepted or widely used. As with all else in life, it seems COVID-19 is changing that, and for once, this change seems to be positive.

In response to COVID-19, many insurers are addressing telemedicine by broadening coverage and expanding in-network telemedicine providers. According to the American Medical Association (AMA), the Centers for Medicare & Medicaid Services (CMS) made the following key changes to telehealth guidelines to increase accessibility during the pandemic:

VSI’s Doctor Search now includes a new category listing, “Offers Telehealth.” It is not retroactive, so not seeing it listed does not necessarily mean a listed physician does not offer this option. However, we look for this category to continue to grow as physicians realize what a valuable service this can be for their patients, and we will update the records as we are notified.

So, if you are a patient having difficulty locating a physician willing to prescribe a much needed treatment, click the link below and take a look at this valuable resource. If the listings closest to you do not include the treatment you are seeking, expand your search.

Please join me in welcoming our two most recent entries, both of whom offer current vitiligo treatments, as well as telehealth!

Preparing for an Effective
Telehealth Vitiligo Visit

VSI would like to thank Dr. Nanette Silverberg, member of VSI’s
Medical and Scientific Advisory Committee, for submitting the following article.

Telehealth is an important way to receive care during the COVID-19 pandemic, especially for the many individuals in lockdown states or those who are concerned about elevated risk of travel during these troubling times. Here are some tips to create an excellent visit, while still being able to communicate effectively in 15 minutes. Planning ahead is the key to a meaningful visit.

First, choose your practitioner well. Physicians who see vitiligo frequently are well versed in the variations and concerns of patients with vitiligo. Look to VSI's Doctor Search for practitioners knowledgeable of current vitiligo treatments.

Next, be sure you have the right device. Ask the provider’s office what operating system works best. Should you use your laptop, desktop, cell phone, or tablet? Test your device 15 minutes in advance at minimum, so you can call the office for trouble shooting. Remember, you may wait for telehealth as you might in a doctor’s office. Please be patient and don’t schedule your zoom board meeting back to back with your doctor’s visit.

Place yourself in the proper lighting. If you stand in front of a window, the glare will obscure, or washout, your vitiligo. The best lighting is to have availability of indoor lighting as well as tangential (indirect) outdoor light from a window for comparison. Tangential outdoor lighting offers some of the UV light used in a physician’s office for examination of vitiligo.

If you own a Wood’s lamp (similar to a black light) you could use that in a darkened room during your examination to illuminate the depigmented areas, or you could take photos in advance of areas such as the face, neck, and back, which may require a friend for photographic assistance.

Woods lamps are available on Amazon, but some black lights can be similarly beneficial. Some models will run around $10. If your child has a spy pen with invisible ink and a light to reveal the invisible ink, the latter is often in an effective wavelength. These are all ultraviolet light and it is advised to avoid looking into the light directly.

Blood tests are often performed for generalized vitiligo to screen for associated thyroid disease. Your doctor can identify if you need to do tests urgently or wait. It is okay to ask if you can wait.

Pick a pharmacy that delivers. If you can avoid it, don’t stand in line with sick people to pick up your medications.

Phototherapy may not be available in the COVID-19 pandemic. Talk to your physician about home ultraviolet options including outdoor sunlight.

Some cases require in person visits or biopsies. You should trust your physician to know if this is necessary.

It is okay not to take care of everything in one visit. Time is precious and focusing on what is most important to you now and saving some issues e.g. your acne for a visit in 1-2 months is reasonable. Focus on your vitiligo to get the maximal information.

Nanette Silverberg, MD
Chief, Pediatric Dermatology
Clinical Professor of Pediatrics and Dermatology
Mount Sinai Health Systems
234 E 85th St. 5th Floor
New York, NY 10028

Dr. Silverberg also offers telehealth appointments.
Visit her page on VSI’s Doctor Search here: Dr. Nanette Silverberg

Advocacy

Each fall in years past, VSI has participated in the annual American Academy of Dermatology Association (AADA) Legislative Conference, held in Washington DC. Historically, this meeting has included a two-day immersion on the topics, culminating on day three with Capitol Hill visits to the offices of the participants’ state legislators.

The format this year, as you’ve probably guessed, was virtual. With the exception of a few technical glitches, I think the overall impact was as successful as previous years. There were 312 participants from 41 states, making 274 congressional visits.

Our “team,” comprised of dermatologists, dermatology residents, and patient advocates, called on the offices of 2 Senators and 4 Congressmen. As a patient advocate, my “talking points” included patient protections such as:

Preserve the Four Pillars of Patient Protection

• Pillar 1: Prohibit pre-existing condition discrimination. Individuals must be able to equitably access comprehensive healthcare coverage regardless of their health status, diagnosis, and related factors.
  
• Pillar 2: Prohibit lifetime and annual caps on insurance benefits. Any individual that purchases healthcare coverage must not be able to outspend that coverage and expose themselves to additional, unaffordable fees.
• Pillar 3: Allow children to stay on family coverage until they are 26. Families with affected members face unique and serious financial challenges, and prolonged stability is essential.
• Pillar 4: Limit out-of-pocket costs for patients. Enacting and preserving no-nonsense restrictions that cap out-of-pocket costs is the best way to keep coverage equitable and accessible to all.

House Resolution 2279/Senate 2546: “Safe Step Act”

This act addresses the burden placed on patients by step therapy protocols and pre-authorization requirements often imposed as cost saving measures by insurance companies. These onerous practices frequently result in vitiligo patients not receiving the best treatments at the best time. Being forced to use therapies far less effective, and in some instances less safe, essentially removes the physician’s authority and professional discretion, resulting in continued pigment loss during the most critical early treatment period

Amy Walter is national editor of the non-partisan Cook Political Report and a frequent on-air analyst. In addition to her weekly appearance on the popular “Politics Monday” segment on the PBS NewsHour, Amy also hosts WNYC’s nationally-syndicated public radio news program “Politics with Amy Walter” on The Takeaway. She is also a regular Sunday panelist on NBC’s Meet the Press and CBS’s Face the Nation, appears frequently on Special Report with Bret Baier on FOX, and is the former political director of ABC News.

Support VSI

From national advocacy to personal patient support, VSI continues to represent
the voice of the patient, providing trusted and reliable resources to the vitiligo community.

As a 501(c)(3) nonprofit organization,
VSI is dependent on public funding to provide these services.

Sincerely,

Jackie Gardner
Executive Director

Vitiligo and Cannabis:
Research and Treatments

Cannabis and its many derivatives is definitely a hot topic in the United States right now. There are a multitude of products derived from the various types and strains, with one of the most popular currently sweeping the market, being cannabidiol referred to as CBD.

Even with minimal shopping excursions during the quarantine, you’d be hard-pressed not to have come across a display of CBD products. You can pick them up anywhere from gas stations to grocery stores in product options such as tinctures, gummies, topicals, bath bombs, and even for your pet. Fido can enjoy CBD infused calming chews, or hip and joint chews, as well as an abundance of other options.

What is Cannabis?

Cannabis is an annual herbaceous plant from which both marijuana and hemp are derived. Though they both come from the same plant genus, each is a distinctly different strain with completely different properties.

Cannabis Indica, commonly known as marijuana, has very high levels of tetrahydrocannabinol (THC), which is the psychoactive compound that produces the “high” effect associated with marijuana.

Cannabis Sativa, commonly known as hemp, is rich in CBD, an all-natural non-psychoactive compound.

Marijuana contains 5-20% THC on average, with some strains packing up to 30%+ THC.

Hemp, on the other hand, contains less than 0.3% of THC.

To say that medical research into CBD is a rapidly-growing area of interest would be an understatement. A quick search on clinicaltrials.gov turned up 76 studies just in the USA, for a wide variety of conditions such as chronic pain, autism spectrum disorder, post-traumatic stress disorder, Alzheimer disease, anxiety, agitation, knee osteoarthritis, and epilepsy.

Another robust area of interest are the many beneficial pharmacological effects of CBD, including anti-inflammatory, antioxidant, and immunomodulating properties, which are of primary interest as a therapeutic tool for many A/I diseases.

Breaking the CBD Stigma

Because of the relationship of marijuana and hemp, and the fact that both at one time were illegal, CBD has long been plagued by a negative stigma. Thanks to an abundance of scientific research confirming its status as a non-psychoactive supplement that will not make a person high regardless of how much, or in what form, it is consumed, the taboo is gradually transforming into acceptance.

But is it Legal?

The laws and regulations of use vary depending on the type/strain and location. Marijuana remains illegal on the federal level, with each state having its own laws. Some allow for medicinal usage, while a much lower number allow adults to use high -THC marijuana for recreational purposes.

CBD has been federally legal since 2018, making it legal, or legal with restrictions, in all except 3 states in the USA. Similar to marijuana, the laws and regulations vary by state. There are three categories governing the use of CBD in the USA.

CBD Legal States 2020

CBD and Autoimmunity

An A/I disease occurs when a person’s own immune system mistakenly targets and attacks their own healthy cells. The location of the A/I attack varies based on the condition. With vitiligo, the body mistakenly wages an attack on the pigment-making cells (melanocytes).

The most common mainstream drugs used to combat A/I diseases are immunosuppressives that turn off, or suppress, the immune system by attacking A/I antibodies. Though this does reduce the impact of the A/I disease on the body, it does so by weakening the immune system, leaving it vulnerable to infections and viruses.

Although vitiligo is treated with immune-suppressing therapies, they are most often topical ointments or UV light, which do not suppress the immune system to the extent of becoming immune-compromised. The exception to this would be the few short-term systemic treatments prescribed to stabilize very active and widespread vitiligo, such as oral or injected corticosteroids like prednisone or triamcinolone acetonide.

Unlike mainstream A/I treatments that suppress the immune system, CBD has immunomodulating properties which work to regulate (balance) the immune system. A balanced immune system is the body’s primary protection against sickness and disease.

The distinction between immune modulation and immune stimulation is very important to those with A/I diseases. Remember that with autoimmunity, your immune system is already attacking some part of your body. You don’t want to up-regulate, or stimulate, that response.

We know from research that immune-boosting supplements like echinacea and spirulina have the ability to not only make preexisting A/I diseases worse, but to precipitate or trigger A/I diseases in those who are genetically predisposed.

Read more about herbs and A/I disease here

Vitiligo, T Cells, and Oxidative Stress

Over a decade of research has shown that vitiligo is an A/I, inflammatory skin disease in which oxidative stress plays a significant role in activating the A/I response that helps trigger the onset of vitiligo.

Vitiligo is also one of many T cell-mediated A/I diseases. In healthy individuals, T cells are part of the immune system that help protect the body from infection. However, T cell defects occur in many organ-specific A/I diseases (such as the melanocytes with vitiligo) and become cytotoxic (toxic to cells), contributing to the destruction and eventual death (apoptosis) of melanocytes.

In our Winter 2019 newsletter, we reported a recent research discovery regarding the reason that many times when a person experiences a vitiligo relapse, they lose pigment in the exact same location as a previous lesion. It turns out that there are A/I memory T cells.

This is another example of autoimmunity causing problems with what should be a protective function. In the case of vitiligo, memory T cells are established at the location of the original attack on the melanocytes, and remain there long after repigmentation, awaiting another opportunity to wreak havoc, causing pigment loss in that same location.

Other factors making CBD a potential therapy not only for A/I disorders, but specifically vitiligo, are its properties as a potent antioxidant helping to reduce oxidative stress, decrease systemic inflammation associated with A/I conditions, and slowing down T cell production, that could help suppress immune system memory, which could play a role in reducing vitiligo relapses. Read more about memory T cells here.

CBD Treatment for Vitiligo

VSI recently discovered a patent application published in February 2019 for a CBD treatment for vitiligo. The basis of this patent is a research study carried out by Lekhram Changoer, from Ridderkerk, Netherlands, and George Anastassov, from New York, NY, on behalf of AXIM Biotechnologies.

The treatment used in the study was a topical application composed of two cannabinoids, (chemicals found in cannabis), cannabidiol and cannabigerol.

According to the study, as with CBD, cannabigerol (CBG) does not have psychoactive effects and is not considered a controlled substance under the Controlled Substances Act as long as it is not produced from the controlled parts of the cannabis plant.

The patient in this study had severe vitiligo that had been resistant to therapy for many years, but had received no therapy for at least 6 weeks prior to the study.

The researchers selected 2 vitiligo lesions, at least 20 centimeters apart, on the subject’s left arm to be treated in the study, and 2 corresponding lesions on the right arm as controls.

Axim Biotechnologies prepared two types of a topical CBD/CBG oil, with different strengths, both containing a 2:1 ratio of CBG to CBD for the study.

Twice a day for 6 weeks, one lesion on the left arm received a thin application of the 3% concentration of the CBD/CBG topical, while the other was treated with the 15%.

The two lesions on the right arm were treated with a 0% CBD/CBG oil (placebo) serving as the control.

At the end of the 6-week study period, repigmentation of each lesion was compared to the color prior to treatment. The lesions treated with the 0% and 3% oil showed zero response. However, the 15% treated area achieved an 11% improvement.

The researchers noted that the repigmentation appeared in what is recognized as a “diffuse” pattern. While this pattern is quite often experienced in cases with rapid repigmentation, unfortunately, it can also be the least stable (long-term) of the different types.

Pigment originating from the melanocyte reservoir (in the hair follicle) most often leads to a "perifollicular" or "follicular" pattern, and appears as a small dot or freckle emerging from the hair follicle inside the depigmented area.

Diffuse repigmentation is when new pigment does not come from the hair follicle, but is recruited from nearby melanocytes in the skin of the lesion.

Due to the time involved for the migration of the melanocytes from the reservoir, up the hair shaft, to the epidermis, follicular repigmentation patterns can take 2 to 3 months. However, these patterns are typically more stable (long-term) than diffuse repigmentation.

In the case in this study, the new pigment disappeared within a few weeks after the treatment was discontinued. However, when taking into consideration the very short treatment time, combined with the long-term treatment resistant history of the patient, the researchers found the outcome “remarkable,” further noting that a longer treatment time might have produced even more positive results. Click here for photos of repigmentation patterns.

Healthline Warning:

CBD may also interact with other medications or dietary supplements you’re taking. Exercise particular caution if you take medications, such as blood thinners, that come with a “grapefruit warning.” CBD and grapefruit both interact with enzymes that are important to drug metabolism, which may cause dangerous levels of the drug to build/occur.

While it’s still early in the research/development of these types of products, and how they might be used for vitiligo, we will be watching closely for new developments. VSI will keep our members notified of any updates or news on this topic in future newsletters.

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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. My doctor prescribed the use of tacrolimus (twice a day) and NB-UVB light treatments 3 days a week. I’ve been using the tacrolimus for a couple of weeks, and just started the light treatments this week. The day after my light treatment, I was so encouraged because the depigmented area had turned pink, but by the next day it had gone back to white. Does this mean the treatment isn't working?

The combination therapy your doctor prescribed works in 2 ways.

1. Tacrolimus is a topical immunosuppressive, which works by suppressing the immune response locally (where it is applied), thereby reducing the attack on, and destruction of, the melanocytes.

2. Phototherapy is immunoregulatory, and works by promoting melanocyte repopulation.

Once the immune response (attack) begins to subside, allowing the melanocytes to once again flourish, then (as mentioned in the above article) they begin the migration process up the hair shaft to the epidermis.

With consistent treatment, you should begin to see new freckles of pigment within a few months that will continue to appear and grow in size, until they eventually blend together and fill in the area.

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Medical News Updates

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

Research Highlights Positive Impact of Corrective Cosmetics?

A group of researchers in Cairo, Egypt recently conducted a one-month study to assess the following three criteria regarding the use of cosmetic camouflage (CC) for vitiligo patients who were also undergoing treatment:

1. The impact of vitiligo on the quality of life (QoL) in vitiligo patients

2. The degree of willingness/acceptance of regular use of CC

3. The impact of regular use of CC on the QoL, while undergoing treatment

They noted that even when using treatments for vitiligo, halting disease activity and inducing repigmentation can take many months, during which time patients with evident contrasting skin color experience deteriorated QoL.

The length of the study was intentionally designed for the short duration in order to avoid any impact from repigmentation, which generally takes longer than one month to be evident.

The use of CC has been shown to reduce the level of stress and improve psycho-social well-being, as well as improve adherence to medical therapy. However, the time and difficulties involved with regular application often result in dissatisfaction and diminished usage.

Study inclusion Criteria included:

All Participants Received:

The study included 100 patients (56 male, 44 female), ranging in age from 4 to 70 years,
with disease duration ranging from 2 weeks to 10 years.

A detailed personal history evaluation including information about disease duration and given a vitiligo disease activity (VIDA) score

•  VIDA measures disease activity during the past 12 months, using a 6-point scale from –1 to +4.
   Higher scores indicate more recent disease activity.

A comprehensive questionnaire regarding the use of camouflage

Medical treatment, including phototherapy tailored to their skin type

Two QoL assessments: (first at baseline, second, one month after therapy)

•  Adults used the Dermatology Life Quality Index (DLQI)
   Children and adolescents used the Children's Dermatology Life Quality Index (CDLQI)

Baseline DLQI/CDLQI Results:

DLQI/CDLQI scores ranged from 1 to 24, with 36% of all patients having a score > 10,
indicating a very large to extremely large QoL impact on daily lives.

Camouflage Questionnaire Results:

100% of the participants indicated a desire to use CC. Sixty out of the 100 patients reported they were already using some form of camouflage in their daily life. However, of those 60, the majority (78%) used some type of clothing to cover/camouflage rather than CC.

Forty (of the 60) reported the following reasons for not using CC on a regular basis:

The Camouflage Subgroup:

Forty patients were randomly selected to receive skilled training on camouflage application and free products to last for the duration of the study. Each participant was photographed before and after the camouflage application.

DLQI Results after 1 Month

The DLQI showed significantly higher scores (indicating lower QoL) among those with active vitiligo.
The average DLQI score for those with active vitiligo was 20.1 compared to 8.4 for those with stable vitiligo.

While both groups showed a significant reduction in DLQI scores, the reduction in scores (indicating QoL improvement) was significantly higher in the camouflage group. However, the DLQI scores indicated the highest QoL improvement among skin type III patients, compared to skin type IV and V. They attributed this difference to less efficient camouflage coverage for the darker skin types.

DLQI scores among camouflage group dropped from 13.4 at the onset to 7.5 one month later.

Non-camouflage scores dropped from 11.9 to 10.6.

The researchers stated this finding as confirmation of the distress patients experience when losing pigment even when repigmenting (locally) in other areas, further noting the importance of stabilization management.

The researchers felt that guidance on color matching and proper application technique in a non–time-consuming manner helped patients overcome the challenges previously associated with CC dissatisfaction.

They stated that; based on their results, dermatologists should discuss camouflage use at the first office visit, to be used in conjunction with repigmenting treatments. While the improved QoL impact was most profound in newly diagnosed cases, they noted that CC also has a role for those who’ve experienced excellent repigmentation on some areas, but have residual areas not yet complete.

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Research & Clinical Trials

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