The Power of Sharing Your Personal Story

Kim Cantor

by Kimberly Cantor, Senior Director of Advocacy and Government Relations

A personal story is powerful – to those who tell it and to those who hear it. On June 24 and 25, lupus activists from across the country will meet in Washington, DC for the National Lupus Advocacy Summit, where lupus activists will unite to tell their stories to help solve the cruel mystery of lupus.

The Lupus Foundation of America’s legislative successes would not be possible without the power of lupus activists across the country who work tirelessly to make their voices heard both locally as well as on a national level. For example, their compelling and personal stories have helped:

• Secure more than $27 million for the National Lupus Patient Registry and lupus epidemiological studies at the Center for Disease Control and Prevention (CDC);
• Illustrate the clear impact lupus has had on those who serve in the military by keeping lupus listed as a disease area eligible for research funding under the Peer Reviewed Medicare Research Program (PRMRP) at the Department of Defense resulting in more than $12 million in lupus research to-date; and,
• Encourage 48 bi-partisan members of the United States House of Representatives to join the first-ever Congressional Lupus Caucus led by Representatives Tom Rooney (R-FL), William Keating (D-MA), Ileana Ros-Lehtinen (R-FL), and Jim Moran (D-VA). 
• Increase funding for health professional education, which led to the creation of The Lupus Initiative
• Co-found the Ad Council's first national lupus awareness campaign on lupus along with U.S. Department of Health and Human Services' Office on Women’s Health (OWH)

However, there is still so much to be done. Lupus is one of the cruelest, most mysterious diseases on earth, yet research on lupus remains underfunded compared to its scope and devastation. Together, we can change this. During the first day of the Advocacy Summit, activists will receive training on basic advocacy principles and the Foundation’s legislative priorities. Day 2, activists will travel to Capitol Hill and meet with their Members of Congress to tell their lupus story, using their story to educate Congress on the Foundation’s legislative priorities, why these priorities are important to people with lupus and to raise awareness of the disease.

Sharing your story and engaging in advocacy is powerful and empowering. We encourage you to become a lupus activist and to engage with your Members of Congress through e-mails, phones call and in-district visits. Plus, there is still time to join the Foundation on June 24 and 25 for the National Lupus Advocacy Summit. Remember: just one story can and does make the difference.

Developing Clinical Trials for Lupus

By Dr. Joan T. Merrill

Dr. Joan Merrill

Clinical trials for lupus have been challenging. The main reason for this is that no two patients are exactly alike, not as people, not in terms of how the symptoms come and go, and not in the fine details of how the immune system disorder plays out. This means that no one treatment works for everybody and for those who might potentially benefit from a given treatment no one dose works for everybody.

When new treatments are tested in clinical trials, the FDA and the drug companies know about these issues, but the challenge is to come up with a simple protocol that can be tested on all kinds of different patients around the world and can answer two simple questions. Is the treatment reasonably safe and does it work better if you do give it than if you don’t give it? If these two conditions are met, the regulatory agencies can consider approving it for use in the clinic.

Think about this question, though: Does a treatment work better if you do give it than if you didn’t give it? To answer this question you just need more people to get better in a group who get the drug than in a group that receives placebo (or dummy treatment). So to answer this question it doesn’t matter if up to half the people participating in a clinical trial were never going to benefit from this treatment in the first place. In fact less than half of the people around the world who took Benlysta in the large international Phase III trials actually met the criteria for improvement. Still it did well enough to be approved, now, in a growing number of countries worldwide.

Here are the important questions that have not been answered by that simple question: Which patients are more likely to benefit from Benlysta? How can the dose be optimized for an individual patient? How can we tell, in patients for whom it is not working whether it will never work for them (in which case it should be stopped) or whether it might be of significant benefit if the amount of dose, timing of the dose, or combinations with other medications could be optimally adjusted? The answers to all of these things needs to be worked out and the fact that the FDA has approved Benlysta at only one dose to be given only at rigid monthly intervals is not helping matters.

But even if doctors in clinic were given more flexibility to practice the art of medicine in treating patients with new expensive biologics, it would be difficult to address these important questions about how best to treat individual patients using information from the clinical trials. Remember that a wide range of patients from all over the world, with disparate individual differences in their immune system were treated with Benlysta while still taking various additional lupus treatments, all of which are already at work changing the immune system of each of these patients in different ways. This superimposes a whole lot of treatment influences onto what we already know are different background immune disorders in the patients. In trying to figure out who is more likely to get benefit from Benlysta or how best to treat those individuals it will be difficult to sort all of this out.

How will we sort all of this out? I want to tell you about our recent study that a large team of doctors and scientists have recently completed as a collaboration between the Oklahoma Medical Research Foundation and Pfizer Pharmaceuticals. The name of the study is BOLD which stands for Biomarkers of Lupus Disease. Biomarkers are detailed bits of biological information that can be picked up from a simple blood test which can be used to sort out very complex questions about individual differences that perturb the balance of the immune system. Some biomarkers that are active in some patients might suggest a disorder that Benlysta could fix. Others might suggest that different types of treatments would be better. Importantly, it has been hard to figure out in any previous studies what the impact of all the various lupus treatments are on these biomarkers which might really confuse a doctor if they were trying to pick out a treatment to either add on or switch a patient to. The BOLD study was designed to begin looking at this very question. Patients who agreed to be in the study were considered qualified to participate if they had active disease, but at the start of the study they could be on various background treatments. A blood sample was taken. After that, unlike most clinical trials, the strong background immune suppressants were stopped. Everyone received a short course of steroids. More blood was sampled when the participants were better. The steroid was allowed to wear off. The patients were followed closely with serial blood donations and they were instructed to return to clinic within three days if their symptoms came back. When a “flare” visit occurred, blood was drawn once more and then the patient was immediately treated.

Before this, almost everything known about biomarkers in lupus has been based on random samples of blood from biologically diverse patients on a cacophony of background medications. Now there is a freezer full of samples donated by patients where we can address biologic diversity by comparing the same patient with active disease on azathioprine (or the other immune suppressants) to themselves when they flare up without that treatment on board. This is how we can learn what the real impact of these agents on lupus is and how some of them, when they are allowed to be used during trials, could be interfering with certain drugs we are trying to study. In the past two years some preliminary data from the BOLD study has already been presented at the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) meetings. Now that the study is completed, the full reports will be out in the next year.

It is well known that lupus patients can be sorted into two major groups, those with inflammation that seems strongly influenced by interferon alpha and those with a much lower interferon influence. The preliminary abstracts that have already been released from the BOLD study are suggesting that many other factors that distinguish one patient from another, including the impact of immune suppressants, might be better understood by appreciating that they have different impacts on the interferon low and high groups. A better understanding of how to sort lupus into biologically meaningful subsets, and the biologic influence of background treatments on each of these groups may help to better design and interpret clinical trials as well as to inform better and more precise medical care for individual people in the future...not just for 50% of the people.

From the Motor City to Lupus Awareness Month

by Mary Crimmings, VP of Marketing & Communications 

I’m able to get home to Michigan to see my family 2 times per year, usually around the holidays. When we connect in person it is time to relax, have fun and catch up on each other’s lives. During each visit my family learns a bit more about lupus as they ask me about my job and what I’m working on. But during my visit home earlier this month, the lupus stories and facts they’ve heard from me came alive when my family visited the purple lupus awareness bus. While on the bus it was the videos of personal stories from people living with lupus that touched their hearts and provided a true emotional connection to the disease. Their visit demonstrated that even those who have some awareness of lupus can gain better understand of this disease.

As you might have guessed, the reason for my visit home was not to see my family (although that was a bonus, especially meeting my new niece), I was in the Motor City for the Detroit stop on the Lupus Foundation of America’s Help Us Solve the Cruel Mystery™ National Tour. I was so pleased that Detroit was selected to be one of the cities selected for the first phase of this tour. And then after spending three days talking to metro Detroiters at the bus and the education program, I was filled with enormous pride for my organization and the teams who have worked so hard to make this program a reality.

Everyone I talked to mentioned how much they learned (including my dear friends who came out in the rain and snow to visit the bus). However, I continued to be struck by the many people we met at the bus who have a personal connection to lupus but, as our research revealed, really don’t know much about lupus beyond the name. And I was heart-broken to hear too many stories from people who lost a loved one to this cruel disease.

The weekend was affirmation of our work and that we must continue to connect to people with lupus and provide them with the latest information on the disease, and we must continue our efforts to gain better public understand of lupus. It is with greater awareness and public support of this disease that we will be able to secure more funding for lupus research.

My trip home to Detroit has given me renewed energy to continue the fight on behalf of the millions of people affected by lupus. And I’m excited about the many activities and opportunities we ALL have in the coming months through Lupus Awareness Month and the National Lupus Advocacy Summit to secure greater awareness and understanding of lupus – the cruel mystery.

Those who have a connection to lupus hold the power to make the greatest impact for others to understand this disease through personal stories of how lupus has affected their life! So as we look though our closets to wear purple (the color for lupus awareness) during Lupus Awareness Month, let’s not forget to also start the conversation about lupus. Asking someone a simple question such as, Have you ever heard of lupus? or Do you know someone with lupus?, opens the door to share a fact or story about the disease, invite someone to sign the petition to Congress asking for more lupus research, and engage others to join the fight against this cruel and mysterious disease.

I’m working on my own personal lupus awareness month outreach plan – how about you?

Getting Help is Closer Than You Think

by Christine John-Fuller, President and CEO of the Lupus Foundation of America North Carolina Chapter

Christine John-Fuller (right) with volunteer Tameka Joyner at the 2011 NC Lupus Summit

The Lupus Foundation of America has an ambitious goal: Improve the quality of life for all people affected by lupus. The cruel mystery of lupus does not daunt us. Our role is to help everyone with lupus be informed, engaged, and hopeful. We work to improve the lives of all people affected by lupus.

For those that don’t know, I have the greatest job on the planet as the President & CEO of the Lupus Foundation of America, North Carolina Chapter. Currently, I am finishing the last leg of an eight-city NC Lupus Town Hall Tour. In every city we’ve held a meeting, one comment from the audiences keeps getting voiced, “Please tell me about the support available to me here in my area.” And after more than two years of work towards expanding to a statewide chapter, I’m excited to share with them all we have to offer and can do to help. This list is extensive and many times they respond in surprise not realizing all the ways we can offer hope and help.

But this question is not unique to North Carolina, it is the same question that individuals affected by lupus ask across our country. And too many times, those who need help the most don’t truly understand how we can help. So allow me to break it down for you.

We not only fund research – we serve those living with lupus NOW.
In our pursuit of solving the cruel mystery of lupus with better treatment options and ultimately a cure, we also know that we have people who are confronted every day by lupus’ brutal impact, and we are the only national force devoted to doing so.

Regardless of where you live, we are here to help you.
No matter where you live in the United States, there are services established to help you. The Lupus Foundation of America National Network is composed of chapters, offices, and support groups in communities throughout the United States. But don’t make the assumption that too many individuals make. Just because there isn’t a physical office in your hometown, doesn’t mean there isn’t help out there for you. Think of it this way, could we possibly even afford to have an office in every town across America, OR would you rather we pool our resources so we can offer more services to more people, like you, that need help? Our network provides information and programs to ensure people with lupus and their families get answers. I encourage you to contact your closest chapter today to see what they may offer in your area.

No office close to you? No problem.
Did you know we have National Health Educators that are here to serve you? If you don’t have a local office, the Lupus Foundation of America Health Educators are available to take your call and help with whatever your need may be.

We are on this journey with you.
From discovery of symptoms to diagnosis to managing life with a chronic disease like lupus, we are on this journey with you. We know that lupus affects more than just the physical, it can have emotional, relational, and financial implications as well. We want to be the fourth cornerstone in the foundation of your support, with the other three being you, your healthcare team, and your caretaking team. Together, you are better equipped to handle anything that may encounter along the road…no matter whether yours is a rural dirt road in NC or a bustling metropolitan boulevard. We’re always here to be your traveling partner.

Guest Blog: For You, Mom

by Jan Angilella

Jan from Cincinnati

My mother was diagnosed with lupus in the 1960s. But it went dormant for many years, with no outward symptoms. It wasn’t until the late 1980s that she started having more serious health issues and then it snowballed. I remember telling friends about the disease and was often met with the question, “What’s lupus?”

When I saw the presentations inside the Help Us Solve the Cruel Mystery™ tour bus last week, I knew that so much progress has already been made just in awareness alone. This is an insidious, mysterious disease that needs more attention and more research to find a cure. That’s why I signed the petition to Congress asking for their support in funding research for a cure as well as safe, tolerable treatments.

I went through it with my Mom. She lived with the swollen joints, the dry eye and then the failed kidneys. I gave her one of mine in 2003 and her life changed after that. But lupus effects stick around. She still had bone issues, her feet were still swollen, she had to watch her diet – too much protein, not enough protein – and there was always fatigue.

I lost my mom in 2011 but her spirit lives on in me. There is a hole in my heart that will never heal, yet I am empowered by her life, her strength. And so I will help solve the cruel mystery that is lupus in any way I can. The bus tour is well done and answers a lot of questions about the disease. Let’s find a cure.

A Health Educator's Perspective: Sun Sensitivity and Lupus

Dawn Isherwood, RN, BSN

By Dawn E. Isherwood, RN, BSN,
Health Educator, Lupus Foundation of America

We hope everyone is enjoying the start of the spring season and the warmer weather!

Each year, as the flowers start to bloom and the weather gets warmer across the country, calls into the Lupus Foundation of America significantly increase with questions about light sensitivity. Two-thirds of people with lupus have increased sensitivity to ultraviolet rays, either from sunlight or from artificial inside light, such as fluorescent light -- or both. While we all know it is not possible, especially this time of year, to avoid ultraviolet light all together, for those living with lupus, it is important to protect yourself from these strong rays.

Photosensitivity or abnormal light sensitivity is a major symptom of the cruel and mysterious autoimmune disease we call lupus. If you are living with lupus, exposure to the sun can cause skin rashes. Beyond skin rashes that can develop, exposure to the sun, as well as artificial inside light, can cause increased disease activity with symptoms such as joint pain, weakness, fatigue and fever. This is not exactly the reaction we all want when enjoying the warm sun.

So why do people with lupus have this reaction to ultraviolet rays? Normally skin and other cells that are sufficiently damaged by ultraviolet light die through a process known as programmed cell death, or "apoptosis." The body then gets rid of the dead cells. Unfortunately for those who live with this devastating disease, apoptosis in the skin seems to occur more often than it should, which in turn leads to more inflammation and other side effects. People without lupus do not typically experience this reaction -- though too much exposure to ultraviolet light is not good for anyone.

Staying inside is not the answer -- you should all enjoy this weather. While it is difficult to avoid ultraviolet light all together, there are ways you can protect yourself. Here are some tips that I share with folks:

Avoid Mid-Day Sun
Whatever the weather, avoidance of tropical sun, or the sun in the middle of the day, is the first line of defense. This action alone may reduce the need for other treatments. Of course, avoidance of the tropical or mid-day sun may not be practical in all situations or for all people. If you must be out in the sun, broad-brimmed hats and tightly-woven, loose-fitting clothing with long sleeves and long pants are very effective.

Use Sunscreens
The use of sunscreens form the next and best-known part of sun protection. These preparations are either chemicals which absorb UV light, or pigments such as titanium dioxide or zinc oxide which scatter it. According to Dr. Andrew Franks, “right now, by far the best sunscreen on the market today is Mexoryl™, which blocks both UVA-1 & 2 rays in addition to UVB rays. There is more than one brand, so be sure the ingredient list includes Mexoryl. Products with the Helioplex® compound are close to Mexoryl in effectiveness and also protect against UVA-1 and 2 rays.”


Talk To Your Healthcare Provider or Pharmacist about Your Medications
Some medications may also increase the effects of the ultraviolet rays on a person's body. Antibiotics such as tetracycline or sulfonamides, some diuretics as well other medications have an increased potential of developing "phototoxic" reactions, such as easy sun-burning. If you are taking these "photosensitizing" medications, you will need extra protection against sunlight. Ask your doctor or pharmacist if any of your current or new medications might make you extra-sensitive to the sun.

Avoid Other Sources of UV Light
Sources of UV light other than sunlight can also cause skin problems in lupus. Thus, photosensitivity has been reported from fluorescent tube lights, which mainly emit UVA with small amounts of UVB, and from photocopiers, which emit mainly UVA and visible light. Fluorescent tubes can be fitted with acrylic shields which eliminate UVB emission, while photocopiers should not be used with the top cover up.

Install Light Shields on Windows
Finally, because car and house windows protect just against UVB, not UVA, and clouds only a little against either one, sun protection should not be limited just to sunny days. For windows, effective UV-blocking films are commercially available.

At the Lupus Foundation of America, we want everyone to enjoy the warm months ahead, and hope you find these tips helpful. We invite you to call one of our health educators if you have any questions. You can also visit the Lupus Foundation of America’s website at lupus.org to learn more about photosensitivity and lupus.

**
Dawn E. Isherwood, RN, BSN, is Health Educator for the Lupus Foundation of America. Dawn can be reached at 800-558-0121 or by filling out this contact form.

Act now to reduce lupus medical costs and improve access to treatments

By Kimberly Cantor

Kim Cantor

New medications and those in development to treat lupus are mostly biologics – a type of drug derived from living cells that are extremely complex to create.  With a number of new and innovative treatments for lupus in the drug pipeline, these highly anticipated treatments will mean nothing if people with lupus cannot afford them.

Placing vital, life-saving, yet expensive medications used to treat chronic diseases and conditions such as lupus on a “specialty tier” is becoming common practice among health insurers.  Medications on the specialty tier are typically biologics and are highly specialized drugs with few generic or therapeutic equivalents. 
Under a specialty tier, patients are required to pay a percentage of the cost of the drug or a coinsurance. Traditionally, health insurance plans charge a fixed co-pay (i.e. $10, $20 or $50) for the different tiers (i.e. Tier I, II, III) of medications.  However, coinsurance rates range from 25 percent to 33 percent at times,  costing patients hundreds if not thousands of dollars each month and resulting in extremely high and burdensome out-of-pocket costs for patients.

The use of coinsurance and the specialty tier is becoming more prevalent in insurance benefit design as companies look to control costs and drive enrollees onto cheaper generic drugs.  The problem is that in many cases there are no generic alternatives and co-insurance is causing many people with chronic diseases and conditions to underutilize treatments or go without treatment at all.

Specialty tiers are fundamentally unfair and discriminatory.  And the practice imposes a significant cost-sharing burden on patients who rely on these highly-specialized drugs.  That is why the Lupus Foundation of America is a founding partner of the Coalition for Accessible Treatments (CAT).  CAT is a coalition of 18 national patient and provider organizations working together to address the problems created by the use of co-insurance and specialty tiers.  In 2012, the Coalition successfully worked with Representatives David McKinnely (R-WV) and Lois Capps (D-CA) to introduce the Patients’ Access to Treatments Act (PATA).

PATA seeks to end the practice of discriminating between medications with a fixed co-pay and specialty tier drugs by requiring commercial health insurers to impose the same co-pay obligations for specialty drugs as they do for tier III medications.  Our goal is to increase access to these important drugs and reduce the excessive cost-sharing obligation – paying a hefty coinsurance. 

The Foundation is excited to working with the CAT again this year, and we were thrilled to have our Congressional champions sponsor PATA in the 113th Congress.  On February 4, PATA (H.R. 460) was re-introduced. To date, 29 Representatives have co-sponsored the bill.  We are working diligently to ensure a companion bill is introduced in the Senate shortly.

While not everyone with lupus experiences the challenges associated with accessing drugs on the specialty tier, many routinely experience paying a co-insurance associated with a medication or infusion, and high costs associated with taking multi-medications.  Lupus activists can help curb the practice of co-insurance and specialty tiers. 

We need your help!  Please take a moment to e-mail your Representative today and ask them to co-sponsor PATA (H.R. 460).  PATA will help reduce the cost-sharing burden on people who rely on highly specialized medications and help them avoid becoming more seriously ill or disabled.

Lupus activists from across the country will be asking Members of Congress to support PATA during the National Lupus Advocacy Summit June 24 and 25 in Washington, DC. By encouraging your Representative to co-sponsor PATA, you are helping build awareness for the issue and supporting lupus activists who will be on Capitol Hill this summer.  Thank you for your activism.