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In This Issue

Message From the
Executive Director

Why Does Vitiligo Remain
in the Shadows?

Join VSI’s 2015 Leadership Campaign!

Donor Leaders to be Acknowledged
in VSI’s Summer Newsletter

Generic Drug War:
Vitiligo Caught in the Cross Hairs

Where Do Your Contributions Go?
What Does VSI Do?

What's On Your Mind?
  • How often should I use
    NB-UVB light treatment?
Medical News Updates
  • Measuring the Burden of Vitiligo

  • Oxidative Stress and the Immune
    System in Vitiligo and Thyroid Diseases

  • Confetti Depigmentation as a
    Sign of Rapidly Progressing Vitiligo

Research & Clinical Trials

Bibliography & Sources

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VSI Medical and Scientific
Advisory Committee

  • Pearl E. Grimes, M.D., Committee Chair
  • Ted A. Grossbart, Ph.D.
  • Sancy A. Leachman, M.D.
  • I. Caroline Le Poole Ph.D.
  • Mauro Picardo, M.D.
  • Nanette B. Silverberg, M.D.
  • Richard A. Spritz, M.D.
  • Alain Taieb, M.D., Ph.D.
  • Wiete Westerhof, MD, Ph.D.
For more information
on VSI's MSAC Click Here
 
 

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Contact Us

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Message From the Executive Director

Dear Members and Friends of VSI,

This is always an exciting time of year, as we attend the American Academy of Dermatology (AAD) Annual Meeting. This year’s meeting, held in San Francisco, CA from March 20-24, as in years past brought together the world’s foremost dermatology experts from all corners of the globe.

I attended scientific sessions on treatment advances including exciting new discoveries about potential biologics. Development of such treatments is a direct result of ongoing research identifying new gene associations and pathways. Many of these discoveries are a direct result of our own MSAC member, Dr. Richard Spritz, and his NIH-sponsored genome-wide vitiligo study. This, and all, research would come to a complete standstill if it were not for the patient volunteers that sign up for the research studies. VSI members can give themselves a pat on the back for their continued support of, and participation in the many clinical trials VSI has announced in these newsletters.

I have been especially interested over the past 2 or 3 years at the increase in not only awareness of, but concern for the patient’s point of view, and quality of life, as well as a growing acceptance of “patient-reported outcomes” in the research documentation.

VSI’s input has been sought for a better understanding of the emotional impact of this disease. More physicians are recognizing the importance of patient-to-patient support, and referring their patients to support organizations like VSI. This is quite a departure from the old days when many, if not most, physicians held patient support organizations in contempt. In those days, having a patient seek outside information was seen by many as threatening and interpreted as a lack of confidence in the physician.

I wish I could say that those days are completely behind us, but VSI still hears otherwise from enough patients to know better. I can, however, say with certainty that physicians of that type are on the decline and that the numbers of caring and compassionate physicians replacing them is most definitely on the rise.

Medical education now addresses the importance of honest communication in developing a strong and trusting physician-patient relationship. This brings me back to the discussion of this year’s AAD meeting. I am always moved when sitting in a room filled with hundreds of young dermatologists and one of our vitiligo heroes, like Dr. Amit Pandya, Dr. Henry Lim, or Dr. Iltefat Hamzavi, becomes emotional during their presentation when telling the attendees that vitiligo is a disease of “bruised souls and bruised hearts” and that what patients want most of all - is just to know that you care.

Not only are these men brilliant scientists, but these are the doctors who have come to VSI seeking the patient’s point of view, and have made it their mission to educate all young doctors on the importance of listening and caring. It is doctors like these that truly gives me hope for tomorrow.

Sincerely,

Jackie Gardner
Executive Director

Why Does Vitiligo Remain in the Shadows?


Vitiligo is one of the most prevalent autoimmune diseases,
affecting about 1% of the world population, or about 67 million people.

Yet - Vitiligo Remains….
Misunderstood
Underfunded
Dismissed as a Cosmetic Condition

If you look at the more successfully funded diseases, such as psoriasis,
cancer, and diabetes, you’ll find one thing they all have in common is the
support of a strong non-profit patient advocacy organization.

But… One Thing
The Larger, More Accomplished, Patient Advocacy Organizations
Have In Common,
Is The Unified Support Of Their Community.

VSI lacks the financial resources needed to strengthen the
organizational infrastructure, increase staff, and implement
critically needed programs and services.

Together, We Can Make a Difference!

Please Click Here Now to Show Your Support

 

 

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Click here to make a Campaign Contribution through VSI

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VSI is a 501(c) 3 non-profit organization, federal tax identification number 37-1731960. Contributions are tax deductible to the fullest extent permitted by law.

This organization is a Silver-level GuideStar Exchange
participant, demonstrating its commitment to transparency.

Donor Leaders to be Acknowledged!


Donors who have responded to VSI’s Leadership Campaign
since November 2014, will be honored in VSI’s Summer Newsletter
as we publish* the names of those committing to a higher level of support.

It’s Not Too Late to Join the Campaign!

Please Show Your Support Today!

* If you wish your gift to remain anonymous, please contact VSI and we’ll place your name accordingly.
Click here to request anonymous contribution.  Website upgrades will soon add this option.

 

Please Click Here Now to Read Complete Spring Newsletter!

 

 

Generic Drug War:

Vitiligo Caught in the Cross Hairs


Treatments for vitiligo have historically been few in number, expensive, and difficult to have covered by insurance. To further complicate matters, nearly all treatments prescribed for vitiligo are classified as “off label,” meaning that they have been tested and approved for diseases or conditions other than vitiligo. Even the potent topical steroids often prescribed as first line therapy for vitiligo are technically off-label. However, perhaps because those topical steroids have in the past been quite inexpensive, they were almost always covered by insurance for vitiligo.

As most of our readers know, Protopic, a topical ointment approved by the FDA for eczema, is one of the most often prescribed (off-label) treatments for vitiligo. Because it is off-label, as well as quite expensive, many VSI members have experienced problems obtaining this prescription.

In an effort to improve this situation, in 2012 VSI Executive Director Jackie Gardner met with the Vice President of Medical Affairs for Astellas, the manufacturer of Protopic. The two discussed the barriers that so many vitiligo patients encounter, and Gardner broached the possibility of adding vitiligo as an indication for the drug. Unfortunately, once a therapy is approved by the FDA for use for a specific disease, companies have little incentive to spend the millions of dollars it would take to enter new trials for vitiligo and get it approved for that as well. Another consideration affecting this type of decision would be how much longer the drug would be protected by its patent.

Drug Patent

When a pharmaceutical company develops a brand name drug, much like any other invention, the drug is protected by a “patent” for a period of years. The patent prevents the drug from being copied by other companies. Once the patent has expired, other companies can then begin selling the far less expensive generic copy of the drug

While the meeting did not achieve the desired outcome, VSI learned that Protopic’s patent was set to expire in little over 2 years (September 2014), and instead set its sights on the potential availability of the far less expensive generic form.

Why are Generic Drugs Less Expensive?

In America, due to the regulatory oversight of the FDA, a brand name drug can take 10-15 years of research and over 1 billion dollars to acquire the FDA approval to bring the drug to market. Free of the development costs that brand-name manufacturers incur, once the drug patent expires, generic drug manufacturers step in and make the generic copy for a fraction of the cost of the brand name drug, while still making a profit. This system worked well for many years, with very little regulation involved.

Are Generic Drugs Safe?

To qualify as a generic, a medication must be “bioidentical” to the brand name drug. The manufacturer must prove that the generic drug meets a range of criteria before the Food and Drug Administration (FDA) will approve it for sale to the public.

According to a FDA consumer bulletin:

  • The generic must have the same active ingredient or ingredients and the same labeled strength as this reference product. It must have the same dosage form, such as tablets, patches or liquids. It must be administered the same way; for example, swallowed as a pill or given as an injection.

  • The firm must fully document the generic drug's chemistry, manufacturing steps, and quality control measures. Each step of the process must be detailed for FDA review.

  • The firm must assure the FDA that the raw materials and the finished product meet USP specifications, if these have been set. The USP, or U.S. Pharmacopoeia, is the non-profit, scientific body chartered by Congress to set standards for drug purity in this country.

Protopic’s Patent Set to Expire in Late Fall of 2014

Looking forward to announcing this news, VSI kept a close eye on Protopic’s patent, which seemed inexplicably held up for several months. VSI Director Gardner held off filling her own prescription in the hopes of confirming the generic availability. Around mid-December, she submitted her Protopic prescription refill and was shocked at what followed.

Her prescription had been written for a 100 gram (gr) tube. Her insurance company intervened and indicated that the prescription would need to be filled with the newly available generic drug, marketed as “tacrolimus.”

The pharmacy had not yet received the generic product, and said as far as they could tell the 100 gr tube was not yet available from the manufacturer. However, the most startling news was the cost of this new generic. Because the 100 gr tube was not available, Gardner agreed to instead receive 3 of the 30 gr tubes of the tacrolimus ointment. Her cost after insurance for each 30 gram tube: $84.10. Her previous refill had been for a 60 gr tube of Protopic, (the name brand) with an “out-of-pocket” cost after insurance of $81.56.

2013 Cost of (name brand) Protopic 0.1% ointment - 60 gram tube

  • Total cost before insurance: $400.99
  • “Out-of-pocket” cost after insurance: $81.56

2014 Cost of (generic) Tacrolimus 0.1% ointment - 30 gram tube

  • Total cost before insurance:: $286.59
  • “Out-of-pocket” cost after insurance: $84.10

3 dollars MORE for HALF as much of the GENERIC!

Even more astounding was how little price difference there was between the name brand and the generic. It seems that when a generic drug is first released, due to the initial limited quantity, pricing can be just about as competitive as the market will bear. The prices shown below were obtained from a local pharmacy and are quoted at the full rate, without any type of insurance coverage.

        30 gram laminate tube - 0.1% Ointment

          • Protopic (name brand)    $295.29
          • Tacrolimus (generic)       $286.59

Though this generic was newly released, and in limited supply, a closer look soon began to reveal a far more pervasive situation with generic drug pricing. Piece by piece, VSI’s investigation began to uncover multiple layers of an apparent ongoing controversy regarding the skyrocketing prices of generic drugs, with increases in some cases as great as 8000 percent.

A New York Times article from 2012, describing the rapid rise in generic drug prices as “mysterious,” focused on the ointments and creams that are the staple of dermatology treatments. One ointment, the topical steroid betamethasone dipropionate frequently prescribed for vitiligo patients, was quoted as jumping in price from $18.17 per tube up to $71.28. The article pointed out that the ordinary rules of supply and demand can be murky and illogical in the world of drug pricing.

The influence and somewhat covert interplay of each of the components in the drug distribution chain adds to the over-all complexity. Once you figure in the insurance factor, which includes the all-powerful “Pharmacy Benefit Manager,” you truly have a mixing bowl of agendas rife for corruption.

Drug Distribution Chain

One doctor who also blogs on medical issues cites problems caused by cryptic deals made behind closed doors between the drug manufacturers and insurance companies, leaving the consumer with no idea of the true cost of a drug. In his September 2014 column titled “What is going on with generic drug prices?” he says, “It appears to me that the pharmaceutical companies have stopped their price competition, possibly by secretly dividing up the market and definitely by limiting supplies. If that is true, antitrust laws are likely being broken. Meanwhile, people with chronic illnesses are being squeezed financially even more than they already have been.”

In a January 2015 interview with NBC Nightly News, Ralph Neas, President of the Generic Pharmaceutical Association (GPhA), denied greed as being a factor saying, ”there have been some increases, but if you put them in context you’re still basically talking pennies compared to very expensive brand medicines.” When asked about a drug jumping from 34 cents a day to $7.46, he replied, “it happens sometimes because there can be drug shortages, supply problems around the world, or a whole bunch of market forces.”

Local/Community Pharmacies Also Suffer Collateral Damage

Prices can go up dramatically practically overnight, leaving pharmacies at a loss when the pharmacy benefits managers (PBMs), who set the rates at which insurance companies reimburse the pharmacies, take weeks or months to update the rates. When this occurs, pharmacies are out hundreds of dollars when they are reimbursed far less than the cost they paid the drug companies for the drugs, as they base their prices on the out of date information, then find out weeks or months later that they will be reimbursed pennies on the dollar. Many local pharmacies are being driven out of business as they can't sustain the ongoing losses.

Some pharmacists offered examples of the current situation. One mentioned that his pharmacy lost $3700 on a prescription (and multiple refills) they provided for a single patient, due to the lag in reimbursement rate adjustments. Others spoke of prices increasing over 300% several months ago, but the PBM continued to reimburse at the previous lower rate for over 6 months, resulting in losses of $40 to $100 or more per prescription that these generally small businesses can't absorb. Without these local pharmacies, patients are also profoundly impacted, as they have no place to go for their prescriptions, and also can't afford them.

The National Community Pharmacists Association (NCPA) presented the information to Congress, requesting that bipartisan legislation be introduced to preserve patient access to pharmacies by requiring more timely reimbursement updates from PBMs. You can read more about this legislation below under the “Lawmakers Response” section.

Could This Be A Double Whammy For Vitiligo Patients?

Ominously, the problems with generics may be the beginning of an even bigger problem for vitiligo patients. Topical corticosteroids have long been the first-line treatment for many vitiligo patients, and insurance companies have historically covered the modest cost. In fact, even though side effects preclude continuous, long-term use, often required for treating vitiligo, insurers frequently require their use before they will prescribe a more expensive alternative such as Protopic.

In October 2014, the CBS TV station affiliate in Chicago spoke with a local pharmacist on the soaring cost of generics. The pharmacist specifically cited clobetasol, a topical steroid frequently prescribed for vitiligo. He said that with no changes in ingredients or packaging, this product that used to sell for $10 jumped 3000% overnight to $300.00!

Who, or What, is to Blame?

Though there is no clear indication of what’s behind this sharp climb in prices, there are enough theories to create a bestselling conspiracy novel. VSI’s research uncovered quite a bit of speculation and finger pointing. Read on to see what we found, and to learn more about the potential impact on vitiligo patients.

Monopoly?

Some cite monopoly as the culprit. But how could that be? From airline mergers to PC operating systems, the US government has in the past invoked its ‘anti-trust’ laws to protect its citizens from the unfair business practices such as “price fixing” that can result from business monopolies.

Monopoly

An economic advantage held by one or more persons or companies deriving from the exclusive power to carry on a particular business or trade or to manufacture and sell a particular item, thereby suppressing competition and allowing such persons or companies to raise the price of a product or service substantially above the price that would be established by a free market.

Source: legal-dictionary.thefreedictionary.com

However, it seems that in an industry filled with “take-overs” and “buy-outs,” nearly all of the generic creams and ointments in the US are now made by only three companies: Perrigo, Taro and Fougera.

You may have noticed that the clobetasol product mentioned in the CBS interview with the Chicago pharmacist was manufactured by Taro, also one of the three companies identified as producing the majority of all generic topicals in the USA.

Gray Market Monopoly?

Another type of monopoly is the “gray market monopoly.” Previously, once a drug patent expired and the generic drug manufacturers stepped in, this led to plenteous supplies and lower prices for patients. But now, with many of the generic manufacturers concentrating on the higher margins available in drugs newly available as generics, this leaves older, low margin drugs (like topical steroids) in the hands of a very few, or sometimes even a single generic supplier, creating what is known as a “gray market monopoly.” These monopolies are able to set prices at will since there is little to no competition, and shortages can be created when their production lines are unable to handle the demand, putting further upward pressure on prices.

Greed?

While Mr. Neas (GPhA), may not see greed as being a factor, an August 2012 New York Times article by Katie Thomas noted: “That’s not to say the companies aren’t reaping the benefits of the price increases. In a May earnings call, Perrigo’s chairman and chief executive, Joseph C. Papa, told investors that a “favorable pricing environment” in the company’s prescription drug business was one of the reasons prescription net sales increased last quarter by 84 percent. On Monday, Taro reported that net income for the previous quarter had increased to $62.9 million from $35.7 million last year, a 76% increase.

Pharmacy Benefit Managers?

Known as “drug plan middlemen,” the Pharmacy Benefit Managers (PBMs) negotiate drug prices from the manufacturers on behalf of their clients, such as pharmacies and private companies offering health benefits to large groups. According to “Pharmacists United For Truth And Transparency,” “PBMs influence more than 80 percent of prescription drug coverage in the U.S. and administer drugs to more than 200 million Americans.” The three largest PBMs are Medco Health Solutions, Express Scripts and CVS Caremark.

In addition to the reimbursement practices cited above, other problems are attributed to a lack of transparency with regard to what is known as the “spread,” defined as the difference in price between what the PBM charges its clients for the prescription and the amount the PBM reimburses, or pays out to, the pharmacies that fill the prescription. In one example cited in a Fortune magazine article by Katherine Eban, a PBM billed a client hospital organization $92.53 for a prescription for generic amoxicillin, but only reimbursed the pharmacy $26.91.

Many are calling for reform of these practices, suggesting new business models emphasizing transparency - requiring the PBM to disclose all costs, and to charge clients the same cost they paid, adding only an agreed upon administrative fee.

ObamaCare?

Based on the theory of supply and demand, some blame the ‘Affordable Care Act’ for this unintended side effect. By virtue of the new health care reform law requiring all insurance plans in the program’s exchanges to cover prescription drugs, the increase in demand could be a market force driving the price hikes.

 

Gray Market?

Another interesting twist we uncovered is the shady area known as the “gray market.” Gray market companies, known to be unscrupulous, work outside normal distribution channels (shown in the graphic earlier in the article) to buy up all of the available supplies of targeted drugs at the low margin price, thereby artificially creating a market shortage, then turn around and sell the drugs through a variety of other companies for astronomical profits. In one example given by Rep. Elijah Cummings (D, Md.), a cancer drug was originally purchased from an authorized supplier for $7, then after making 9 stops at various points in the supply chain, increasing in price each time, was ultimately sold to a hospital for $600! Hospitals try to avoid dealing with these companies, but sometimes the scarce supplies make it impossible when a drug is vitally needed.

“These companies are profiteers that zero in on short-supply drugs and sell them at inflated prices,” said Sen. Jay Rockefeller (D, W.Va.), chair of the Senate Committee on Commerce, Science and Transportation.

Other Factors: Co-Pay Programs and Tier Creep

As generic costs rise, insurance co-pays follow suit. What began as a way to help the consumer afford otherwise prohibitively expensive medications has now become a battle between drug manufacturers and insurers, with patients caught squarely in the middle.<

“Tier creep” is driving up the costs of some medications. This happens when insurance companies decide to reclassify a drug from a lower tier to a higher tier with a resulting rise in the co-pay. For instance, says Chris Dowd, Senior Vice President for PSKW, a bio-pharma co-pay program, “Tier 2 drugs (medium co-pay) no longer carry a $25 copay, but a copay closer to $35–$75 — resulting in lower medication adherence.”

A national study of more than 10 million prescriptions for some 5 million patients found that when co-pays reached $50, prescriptions were three times more likely to be abandoned at the pharmacy than when there was no co-pay, and more than twice as likely to be abandoned when the copay was $25.
Protopic is currently classified as a Tier 3 drug (higher co-pay) by Anthem Blue Cross/Blue Shield.

Anthem – Blue Cross Blue Shield
Tier Definitions

Tier 1 drugs have the lowest cost share. These drugs offer the greatest value compared to others that treat the same conditions.

Tier 2 drugs have a medium cost share. They may be preferred drugs, based on their effectiveness and value. Some are newer, more expensive generic drugs

Tier 3 drugs have a higher cost share. They may cost more than others used to treat the same condition. Tier 3 may also include drugs that were recently approved by the FDA.

Tier 4 specialty drugs have the highest cost share. They may cost more than others used to treat the same condition. Tier 4 may also include drugs that were recently approved by the FDA. Specialty drugs are used to treat complex, chronic conditions and may need special handling.

 

Oh, What a Tangled Web We Weave……

There seem to be a lot of moving pieces in this ongoing saga. Much like a suspense-filled drama, each page we turned began a new chapter, with a new cast of characters and sub-plots. Is this the result of a “perfect-storm” of unregulated greed and loop-holes, or will the final act reveal something bigger that’s still lurking in the shadows? Time will tell!

 

What Does this Mean for Vitiligo Patients?

What began as a good news announcement about a pricey vitiligo treatment becoming available as a more affordable and accessible generic drug instead raised new concerns.

If the cost of something as simple as a topical corticosteroid can soar 3000% overnight, VSI is concerned that insurers may react by reclassifying their drug tier, resulting in higher co-pays, and making them as unaffordable as the higher priced treatments such as Protopic – or worse, deciding that since they, too, are off label - to deny coverage altogether.

Lawmakers’ Response

The dramatic spikes in generic prices have drawn the interest of multiple agencies, as well as the US Congress.

May, 2013: Rep. Elijah E. Cummings, Ranking Member of the House Committee on Oversight and Government Reform, introduced H.R. 5853, the "Gray Market Drug Reform and Transparency Act of 2012" to reform gray market drug sales. This Bill was referred to the Subcommittee on Health, but was not enacted.

October 2014: Representative Cummings and Senator Bernard Sanders introduced legislation to cushion the impact on taxpayers when drug prices rise faster than the rate of inflation. In his testimony at a Senate hearing, Sen. Cummings was blunt in his assessment of the problem: “Some companies are exploiting monopolies and disruptions in supply to implement massive price increases in order to reap unconscionable profits.” Unfortunately, the Cummings/Sanders proposal was defeated; however, the problem now has the attention of many lawmakers.

January 2015: Congress introduced H.R. 244 that will require the PBMs to adjust reimbursement rates (maximum allowable costs, or MACs) each week, which should help limit the losses to the pharmacies. The legislation also requires the PBMs to communicate the source on which they base their rate decisions, providing more transparency to the process. Hopefully, Congress will pass this bipartisan Bill!
VSI is tracking this Bill and will keep our members informed of its progress, as well as other legislation affecting our members’ ability to access treatments.

What Can YOU Do?

You can write to your legislators and let them know how the high price of medications has affected your ability to obtain treatments.

Contact Your Legislators!

Most legislators provide a form that you can fill in on their website. It’s easiest if you compose your message first, so that you can copy and paste it into the provided form.

To Locate Your:

Member of the House of Representatives: Click Here 
Senators: Click Here

 

 

Where Do Your Contributions Go?

What Does VSI Do?


Every day VSI receives requests for information, support and services: from providing accurate and current treatment information, connecting patients with local doctors, to ensuring the voice and needs of the vitiligo patient are heard and understood. VSI’s capacity to serve depends on funding, manpower, and our ability to stay connected with the professional vitiligo community.

Photos below were taken during the 2015 American Academy of Dermatology (AAD) Annual Meeting in San Francisco CA. This event provides VSI the opportunity to meet, exchange information, and network with vitiligo world leaders during a single meeting.

VSI Director Jackie Gardner, Vitiligo Researcher John Harris, &
recently appointed VSI Chairman of the Board Vicki Tiahrt

 

Taken at WDS Luncheon
during AAD Meeting
VSI Director Jackie Gardner &
VSI MSAC Chair, Dr. Pearl Grimes
AAD President, Dr. Mark Lebwohl &
VSI Director Jackie Gardner

 

Taken at the Coalition of Skin Diseases Booth in AAD Exhibit Hall
VSI Director Jackie Gardner, NIAMS Director Dr. Stephen Katz &
Former Congressman Todd Tiahrt  & his wife, VSI Board Chair Vicki Tiahrt

VSI continues to lead a wide range of initiatives to increase education, awareness and support. We have fought to change the way vitiligo is addressed by the insurance industry and ensure that patients have access to care from needed specialists. Our collaborative efforts have secured greater federal funding of research. Our accomplishments are significant when you consider that we operate with just one full-time staff person. Just imagine what we could do with increased financial support!

 

To learn more about how VSI uses your contributions:
Click here to take a look at a few of VSI’s 2014 accomplishments

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What's On Your Mind?


Q. When using NB-UVB light treatments for vitiligo, how frequently should the light treatments be administered (i.e., once a week, twice a week, more frequently?)

  1. Research indicates that light treatment frequency should be 2 to 3 times a week on non-consecutive days. The goal is for the depigmented area to achieve a slight pink (within several hours after the treatment) that goes away within 24 hours.

    Treating 3 times a week is considered optimal by most. However, when comparing the results based on the actual number of treatments, those only treating twice a week, achieved the same degree of repigmentation, it just takes longer. While those only treating once a week did achieve some repigmentation over time, when comparing results to those treating 2 or 3 times a week, the results never achieved the same degree of repigmentation.


 

Medical News Updates

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


Measuring the Burden of Vitiligo

As mentioned in the Director’s Message, in years past very little consideration was given to the patients’ point of view, and/or the emotional impact or burden of living with vitiligo. However, the realization over the past 2 -3 years that this aspect of the disease can play a critical role in overall prognosis and eventual treatment outcome, has resulted in emerging research validating the importance of addressing this aspect of the disease. The research outlined below has been developed specifically as a tool to validate and measure the burden of the disease.

In 2013, two different scales were developed to measure the QoL in vitiligo patients – the VitiQoL (Vitiligo-related Quality of Life) and the Vitiligo Impact Scale. Both used similar methods in developing these scales, with slightly different results. The VitiQoL was developed by Lilly, et al. based on in-depth patient interviews and their responses to other dermatology-related indexes like the Skindex-16 and the Dermatology Life Quality Index (DLQI), and contains 16 items relating to life-participation limitations, stigma, and behavior. Shortly thereafter, Guarang, et al. published their Vitiligo Impact Scale, developed in similar fashion which also correlated well to the DLQI and Skindex-16 results.

The objective is for these scales to be used to assess the psychosocial impacts of vitiligo in both clinical and research settings.

In 2015, a French group including Dr. Khaled Ezzedine, and Dr. Alan Taieb of VSI’s Medical & Scientific Advisory Committee (MSAC) conducted a study to assess the burden of vitiligo in greater detail. They developed and validated a questionnaire to use as a tool to evaluate the burden of disease by focusing on skin phototype (coloring from fair to dark).

Initially using a 35 item test on 300 patients, the final Vitiligo Impact Patient Scale (VIPs) consisted of 29 items. 21 items were common to both fair and dark-complected patients, while 3 were specific to fair skin, and 5 to dark skinned patients.

3 areas common to fair skin (phototypes I to III) were:

  • Psychological
  • Relationships & Sexuality
  • Care & Management of Disease

4 factors related to dark skin (phototypes IV to VI) were:

  • Daily Life & Relationships
  • Self-image & Sexuality
  • Psychological
  • Economic Constraints

Their objective is for the test to be used to evaluate the burden of vitiligo in adults,
and also to assess changes in the individual burden before and after treatment
.


Oxidative Stress and the Immune
System in Vitiligo and Thyroid Diseases

Two processes have long been thought to play a part in the development of vitiligo: oxidative stress and autoimmunity. Oxidative stress, an imbalance between oxidant and anti-oxidant levels in the body, can cause hydrogen peroxide to build up in the skin (among many other biological/physiological processes), damaging the melanocytes (pigment cells). Oxidative stress is the reason why research into using antioxidants either topically, in supplement form, or in the diet has increased.

The relationship between autoimmunity and vitiligo has been well-documented, especially through the work of VSI MSAC member Dr. Richard Spritz, who has traced the genes involved in vitiligo and found many to be associated with several other autoimmune diseases like thyroid disease, autoimmune diabetes, and pernicious anemia. It is now generally accepted that autoimmunity plays a role in generalized vitiligo, though the exact processes remain under investigation.

Until now, researchers thought that the oxidative stress and autoimmunity processes were separate. An Italian group, however, has just published a study (March 2015) that says that not only are both processes related, but they are synergistic. They theorize that perhaps the immune system creates a chronic inflammatory environment that allows reactive oxygen species (ROS – typically hydrogen peroxide) to proliferate and damage surrounding cells. The chronic damage that accumulates then triggers an immune response, creating a vicious circle of pigment damage.

This publication cites another related study that analyzed anti-melanocyte antibodies (indicating autoimmunity) and lipid peroxidation levels (oxidative stress) in both recently developed vitiligo, and long-duration vitiligo. Interestingly, this group found that the lipid peroxidation levels were much higher in the recently developed vitiligo, while the antibodies were more prevalent in vitiligo of longer duration. They felt that oxidative stress might trigger the cycle of inflammation/damage/autoimmunity rather than the other way around. Either way, both studies point to the interrelationship between oxidative stress and autoimmunity in vitiligo.


Confetti Depigmentation as a Sign of Rapidly Progressing Vitiligo

Dr. Amit Pandya and his Dallas, TX research group are awaiting publication of his research into whether the presence of  numerous (dozens to hundreds) small areas of depigmentation in a confetti-like pattern reveals rapidly progressing vitiligo in patients not receiving treatment.

They conducted a retrospective, single center chart review of 178 patients. 15 of those patients exhibited a confetti type depigmentation pattern, and 7 who met the criteria of having this pattern of depigmentation, a follow-up image available, and were not undergoing treatment, were ultimately included in the study.

After evaluation of the 13 images from these patients that were assessed at baseline and follow-up 16 weeks later, they found that depigmentation had increased from 19% to 51% over that period, an increase of 32%! Two patients with an additional follow-up at 31 weeks had depigmentation that had increased to 71%, another 53% increase.

They concluded that this pattern of depigmentation may indicate rapidly progressing vitiligo requiring immediate and aggressive treatment to stabilize the disease activity.

Some dermatologists will treat aggressively advancing disease manifested by many new lesions, and widespread confetti depigmentation with oral systemic steroids. This type of therapy must be administered very carefully to avoid side effects and is typically prescribed with pulse dosing.

For sources and additional information on this type of systemic therapy, see the newsletter Bibliography.

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Research & Clinical Trials


New Pilot Study In Boston MA

Open-label Pilot Study of
Abatacept for the Treatment of Vitiligo

Principal Investigator: Dr. Victor Huang

Study Location:
Brigham and Women’s Hospital Clinical Research Program
221 Longwood Ave. Boston, MA 02115

Abatacept has been shown to decrease T cell activity and reduce symptoms associated with rheumatoid arthritis. Similar pathways have been shown to be involved in vitiligo.

This study is seeking adult patients with active vitiligo to receive 24 weekly self-administered injections of abatacept, to see if the vitiligo lesions stop spreading, and start to repigment.

A 32 week follow-up visit will be performed to evaluate secondary endpoints as well.

Inclusion Criteria:

Must be over the age of 18

Must have actively progressive vitiligo (defined as development of new lesions or worsening of existing lesions within the past 6 months) covering at least 5% of body surface area

Subjects receiving treatment at the time of screening will be eligible providing they undergo a wash out period prior to starting the study

Women of childbearing potential (WOCBP) must be using an acceptable method of contraception throughout the study and for up to 10 weeks after the last dose of study drug, and have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 48 hours before the first dose of study drug

Sexually active fertile men must use effective birth control if their partners are WOCBP

Exclusion Criteria:

Pregnant or breastfeeding patients

Patients with segmental, acrofacial, or universal vitiligo

Patients with evidence of white hairs within the majority (>50%) of their vitiligo lesions

Patients currently on any other systemic biologic medication, current use of Abatacept, or any other systemic biologic medication within 2 months of study

Use of systemic immunosuppressive agent within 2 weeks prior to initiation of Abatacept
For additional study criteria see contact information below.

If you are interested in participating or would like more information:

Contact:
Dr. Victor Huang  ph: 617-732-4918  or 
Peter Douglass PDouglass1@partners.org


 

New Segmental Vitiligo Study in Detroit MI and Worcester MA

Study to Identify the Autoimmune Mechanism Behind Segmental Vitiligo

Principle Investigators

Study Locations:

UMass Dept. of Dermatology
55 N. Lake Ave
Worcester, MA 01655

 Henry Ford Dept. of Dermatology
3031 West Grand Boulevard
Detroit, MI 48202

Scientists from three United States academic centers are collaborating to identify how and why the immune system initiates an autoimmune attack against specific pigment cells in segmental vitiligo. By understanding why this happens, new treatments targeting this process can be designed.

In segmental vitiligo, pigment cells on one side and area of the body are destroyed leaving a white area behind. One theory as to why this specific area loses its pigment cells is the pigment cells in segmental vitiligo may express different proteins from other pigment and non-pigment cells in the body. In order to identify these differences, a thin piece of repigmented (regain of color) vitiligo skin and sample of blood is needed.

Your participation is vitally needed

Eligibility requirements:

  • Ages: 7-89 years of age
  • Diagnosis of segmental vitiligo
  • At least 1 spot of repigmentation (regain of color) within the segmental vitiligo

Exclusion Criteria: The following will not be eligible:

  • Diagnosis of generalized vitiligo

What will happen if I participate?

  • A small amount of blood will be collected in the same manner as blood drawn at your regular doctor’s office.
  • A superficial piece of tissue (shave biopsy) will be taken from the area of segmental vitiligo. Shave biopsies are a common procedure performed at dermatology offices.
 To participate, or for more information:
Contact: Dr. James L. Griffith
Phone: 313-916-6964 or Email: jgriff10@hfhs.org


 

New Autoimmune Vitiligo Study in Detroit

Role Of Immunosuppressive Cells In The Development Of Vitiligo

Principle Investigator:

Iltefat Hamzavi M.D.

Study Location:
Henry Ford Department of Dermatology,
3031 West Grand Boulevard Detroit, MI  48202

Patients with vitiligo often have either a personal or family history of other
autoimmune conditions. This association may be due to a common underlying
immune mediated mechanism. As humans have an active immune system to fight
off infections and viruses, a check-and-balance system exists to keep the immune system from attacking your own cells. When the immune system attacks the body’s own cells, we call this an autoimmune condition. In our study, we are trying to assess the role of regulatory cells for the immune system in the development of vitiligo. Ultimately, the goal of this research is to find new therapeutic strategies for autoimmune vitiligo to stop an ongoing immune attack on pigment cells in active vitiligo

Eligibility requirements:

  • Ages: 18-89 years of age
  • Diagnosis of generalized vitiligo
  • No personal or family history of other autoimmune conditions is required.

Exclusion Criteria: The following will not be eligible:

  • Women who are lactating, pregnant or planning to become pregnant

What will happen if I participate?

  • Demographic (age, gender, ethnicity) and medical history will be collected.
  • A small sample of blood will be collected in the same way that blood is drawn at your regular doctor’s office.
To participate, or for more information:
Contact: Dr. James L. Griffith
Phone: 313-916-6964 or Email: jgriff10@hfhs.org


 

New Needling Clinical Trial in New Jersey

Assessing the Efficacy of Needling
With or Without Corticosteroids in the Repigmentation of Vitiligo

Principal Investigator:
Babar Rao MD

Study Location:

Rutgers - Robert Wood Johnson Medical School
1 World’s Fair Dr, Somerset, NJ

Needling is an office-based procedure that transposes healthy, pigmented skin cells to depigmented areas using a needle. This trial will investigate the use of needling to treat vitiligo. It will compare needling alone to needling with corticosteroid.

Eligibility Requirements:

  • Ages: 18 – 89 years
  • Patients with 3 or more localized patches of stable vitiligo
  • No prior treatment or had failed previous vitiligo treatments.

Exclusion Criteria:Those with the following will not be eligible:

  • Unstable vitiligo (no new or changing lesions in past 6 months)
  • Allergic to triamcinolone
  • Using systemic treatments
  • Pregnant
If you are interested in participating or would like more information:
Contact: Aida – 732-235-7765   or   Danielle - giambrda@rwjms.rutgers.edu


Melanocyte-Keratinocyte Transplant Procedure
Opportunity in Detroit!

Comparative Study Using Dermabrasion versus CO2 Laser
and Collagen Dressing versus Vaseline Gauze in MKTP

Principle Investigator: Iltefat Hamzavi, MD

Study Location:
Henry Ford Department of Dermatology,
3031 West Grand Boulevard Detroit, MI  48202

The melanocyte keratinocyte transplant procedure (MKTP) involves transplantation of the skin cells that produce pigment from your normal skin to the depigmented skin. The procedure takes approximately 4 hours and is done under local anesthesia.

This is a prospective, open-label, parallel study comparing two different techniques for preparing the depigmented skin (carbon dioxide laser versus dermabrasion) and comparing two different wound dressings (collagen dressing versus vaseline impregnated gauze) for the melanocyte keratinocyte transplant procedure.

Eligibility Requirements:

  • Must be 18 years of age or older
  • Must have depigmented patches of skin

Exclusion Criteria:

  • History of acral vitiligo (vitiligo on the hands or feet)
  • Unstable vitiligo, defined as any new or enlarging areas of
    depigmentation within the last 6 months)
  • History of thickened scars or keloids
  • History of koebnerization (getting new areas of
    depigmentation at sites of trauma, such as a cut, scrape, or burn)

The vitiligo patch will be divided into four quadrants. Each quadrant will be treated with the melanocyte keratinocyte transplant procedure, as follows:

  1. CO2 laser for denuding the epithelium Collagen dressing
  2. CO2 laser for denuding the epithelium Vaseline impregnated gauze dressing
  3. Dermabrasion for denuding the epithelium Collagen Dressing
  4. Dermabrasion for denuding the epithelium Vaseline impregnated gauze dressing

The patient will return to the clinic for the dressing removal 1 week post-procedure. Repigmentation of the treated areas will be assessed by in-person, or remote examination (emailed photographs) at monthly intervals (1-6 months) after MKTP.

To participate, or for more information, Contact: Dr. James L. Griffith
Phone: 313-916-6964 or Email: jgriff10@hfhs.org


A Special Call To African-American Vitiligo Patients

University of Colorado
Health School of Medicine

International Study to Find Vitiligo Genes

A Special Call To
African-American Vitiligo Patients

Over the past 18 years, we have carried out basic genetic studies of vitiligo, begun with the urging and active participation of vitiligo patient groups, including VSI. Over 10,000 vitiligo patients around the world have taken part. The results have yielded extraordinary progress in understanding the epidemiology and biology of vitiligo. Accordingly, for the first time major drug companies are seriously pursuing vitiligo as a treatment target.

Thus far, our studies have mostly targeted Caucasians, simply because of the large numbers of patients we need for major genetic studies. We’ve also been able to extend our findings from Caucasians to Indian-Pakistani and Asian patients, who have enrolled in smaller numbers. However, we have not been able to extend our findings to African-Americans, simply because we haven’t been able to enroll enough patients from this important group in the USA.

Now, we hope to specifically target African-American enrollment, to understand whether the basic biology of vitiligo that we’ve outlined by studying Caucasians also pertains to individuals of African descent. Otherwise, advances in vitiligo testing and treatment may not be extensible to African-Americans. At the very least we need to enroll several hundred additional African-American vitiligo patients, and also a similar number of unrelated, unaffected African-American "controls”. We believe you are out there, among the membership of VSI. Won’t you please help by participating? There is no cost, all participant information is kept confidential, and you will be potentially helping yourself as well as other African-Americans who suffer from vitiligo.

Your personal information, by law,
will be kept private and will not be sold or disclosed
.

Join with us to work for a vitiligo-free future!

Click here to download the questionnaire

Click Here to Read Research Updates on this Study

 

 

NEW! - Support VSI Through Ebay


 

New Way To Support VSI Through Ebay!

Do you sell items on eBay, or want to hold an online garage sale? If so, consider donating a percentage of your proceeds to VSI through eBay’s Giving Works program! It’s easy – when you list an item through a Giving Works listing, choose to send 10-100% of the final sale price to VSI. Your listing will have a special placement and designation. You’ll receive a proportional fee credit from eBay, and will also receive a tax donation receipt when the donation is deducted from your funds received. It’s a great opportunity to make some money for yourself and for VSI, so clean out those closets and garages and get selling! 

To Learn More About VSI's Giving Works: Click here

 

Earn Funding for VSI 3 Ways When You Shop!


Please keep VSI in mind when you do any of your online shopping

AMAZON SHOPPING

With thousands of items in addition to books, Amazon.com is a one stop-shopping center! Simply shop through the above link (bookmark it for easy reference), or from the Amazon box on our Community Home Page, and VSI will earn fees, based on a percentage of the sale. The more items purchased by members, the higher the percentage! Our Vitiligo Library and Store, containing books, articles and products for those with vitiligo, is also powered by Amazon.

iGIVE SHOPPING

iGive.com offers access to free shipping deals and exclusive coupons, on top of the great deals you'll find every day through its network of 1,000+ stores, including Pottery Barn, REI, Staples, Petco, Expedia, Best Buy, QVC and many more. Best of all, up to 26% of your purchase at each store is donated to VSI at no cost to you! Let friends and family know so they can support VSI, too. Click register for iGive to get started today, and download the iGive button to automatically benefit VSI whenever you go to an included store. You can also raise a penny per search through iGive’s search engine, isearchigive.com.

GOODSEARCH SHOPPING AND DINING!

GoodSearch and Goodshop, like iGive, offers coupons, discounts, and donations to VSI through its network of over 5,000 stores. Just click the link above to get the savings started and the donations flowing!

* Vitiligo Support International Inc. (VSI) is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.

 

 

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