We are pleased to tell you about an exciting new “virtual” fundraiser that will be going on for the next two weeks.  Allison Steinbach, a member of our community and an Independent Consultant with Thirty-One Gifts, has generously offered to donate 20% of sales for all products purchased between November 1 and 19.  Just in time for the holidays, this is a great opportunity to do some shopping for unique, monogrammed handbags, totes, lunch bags, and more for your family and friends (or maybe for yourself!).  There is also a November special going on, so if you spend $35, you can get a Medium Utility Tote for just $5 (a $30 value).

To browse the catalog and order:

Visit www.mythirtyone.com/JoyBags.  Click on My Parties tab on the toolbar, and then the FDRS Fundraiser will appear.  Then simply hit Shop Now.  If you have any questions, contact Allison at 713.478.5244.

A Little Bit About Allison…

Allison just recently moved to Nashville, TN and is a newlywed.  She is very passionate about helping research for both Lipedema and Dercum’s Disease because her mother Leisa (in Houston) was diagnosed with both in rapid succession.  Allison sees firsthand the pain with which Leisa struggles everyday, without any relief or surefire remedies available.  She is hopeful that FDRS can help find a cure for these adipose tissue disorders or treatments to help alleviate the pain.  And that is why she is so generously donating the proceeds from sales for a full two weeks.  Allison became involved with Thirty-One Gifts in July 2012, after receiving the Large Utility Tote, monogrammed with her new last name, as a wedding gift.  She loved using it and started searching around the website to order more of their awesome products.  She then decided to become a consultant and has loved representing this product line and the flexibility of setting her own schedule.  We are very grateful to have Allison in our community and would like to thank her for all she is doing.

Below is information about an FDA initiative. Thirty-nine diseases are in consideration for priority and 20 will be selected. This has a Nov. 1 deadline!

As part of its commitment under the recently approved Prescription Drug User Fee Act (PDUFA V), the FDA will be conducting an initiative, called the patient-focused drug development initiative, to provide for a more systematic approach to obtain the patient’s perspective on the disease severity and the currently available treatments. The intent is to ensure a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options.

Dercum’s disease is NOT on this list!!

HOWEVER,

The FDA is also interested in public comment on disease areas that are not represented on this preliminary list. The Agency used several criteria to develop the preliminary list of potential disease areas. FDA requests that when proposing additional disease areas for consideration, please describe how you applied the identified criteria in making recommendations for additional disease areas to consider.

These criteria include the following:

Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
Disease areas that reflect a range of severity;
Disease areas for which aspects of the disease are not formally captured in clinical trials;
Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
Disease areas that represent a broad range in terms of size of the affected population; or
Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.
FDA will consider the public comments received at the public meeting and through the docket and post the set of disease areas for FY 2013-2015 on the FDA Web site. By the end of FY 2015, FDA will initiate a public process for determining the list of disease areas for FY 2016-2017.

This is an excellent opportunity to help the FDA better understand how fat disorders affect patients. Your support is essential to ensure that your fat disorder is considered in the future as a selected disease.

Please send your comments in by November 1 to ensure that the FDA understands why your fat disorder should be selected. As you write your own letter, make points that reflect how your fat disorder meets the criteria above.

Comments should be submitted electronically at:

http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967

Select ‘Individual Consumer’ for the ‘Category’ and ‘None’ for ‘Organization’ if no other choice is appropria te . Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Further information on the patient focused drug development initiative and the list of 39 diseases initially nominated can be found here: https://www.federalregister.gov/articles/2012/09/24/2012-23454/prescription-drug-user-fee-act-patient-focused-drug-development-public-meeting-and-request-for

Sample Letter – limited to 2000 characters

To: FDA Patient Focused Drug Development Initiative

From: <include your name here>

I am writing to request that Dercum’s disease (also called adiposis dolorosa) be included as one of the diseases in the patient focused drug development initiative.

Dercum’s disease is a complex, chronic pain disorder that was initially identified in 1888 as a lipomatous disorder of unknown etiology.  Dercum’s disease can affect people of all ages with an average age of onset of 35 years.  People have similar signs and symptoms of fibromyalgia but have exquisitely tender fat nodules that cause them to take pain medications including opiates and intravenous lidocaine.  It affects over 300,000 children, men and women in the US of all races and income levels.  Over 60% of people with Dercum’s disease become disabled losing their jobs, spouses and friends. Dercum’s disease is inherited in an autosomal dominant disorder according to a paper in the New England Journal of Medicine.

What is tragic is that over 100 years, there have been no clinical trials for drugs to treat Dercum’s disease and there are still NO approved treatments and NO biomarkers or outcome measures and NO identified gene.

<Include personal story here>

By ensuring a thorough understanding of the severity of Dercum’s disease from a patient perspective, especially given the lack of any viable treatments to change the course of the disease, the patient focused drug development initiative could make a tremendous difference in the lives of a huge number of people.

I want to take a minute to update you all on our website. You have probably noticed the past couple of weeks that the site has changed themes and has been down sporadically. The reason for this is because we just switched web designers. We have big plans for the site, so please be patient while we go through the transition.

Damien Moore

Damien has been active in the Dercum’s Disease community for the past year and a half, as a moderator of the Dercum’s group on MD Junction.  He is a decorated Navy diver who is transitioning back to civilian life after six years of service to our country.  He brings energy and fresh ideas to FDRS and we are all pleased to welcome him aboard.

Tina Tranfaglia

President, October 2010 to July 2012

We have gathered some updates from the worldwide RAD community to share with you.

Dissolution of the American Pain Foundation

On May 3, 2012, the Board of Directors of the American Pain Foundation (APF) formally voted to dissolve the American Pain Foundation citing “irreparable economic circumstances”.  In an e-mail and on their website (http://www.painfoundation.org), the APF states that it enacted key provisions of the National Pain Care Policy Act in the Health Reform Bill that led to a landmark report issued in 2011 by the Institutes of Medicine, documenting the shocking numbers of US citizens who live with pain.  As part of the report, there was a call for immediate changes to address gaps in care.

FDRS remains committed to recognizing pain as one of the major symptoms of several rare adipose disorders, and will support the treatment of pain and the search for new pain treatments with fewer side effects and greater efficacy for our population.

Last Call for FDRS President Candidates

Several great candidates have thrown their hat in the ring to become the next President of FDRS, when Tina Tranfaglia steps down in July.  We are grateful to see such enthusiastic and qualified candidates stepping forward.  If you have been thinking of nominating yourself for the President role, then now is the time to act.  We will accept nominations until the end of May.  To learn more about the role, please visit the job description we posted about a week ago. You can view Tina’s resignation letter and other recent board changes here.

Swedish Researchers Rally for Dercum’s Disease

On May 11, 2012, seven patients with Dercum’s Disease joined Dr. Ola Winqvist and colleagues at the Karolinska Institute in Stockholm. Dr. Winqvist spoke in depth about the immune system and its involvement in Dercum’s Disease. Importantly, he described a specialized column that clears inflammatory cells from the blood – a possible treatment for Dercum’s disease in the future.

Dr. Olle Haglund gave an overview of Dercum’s Disease and provided advice on diet, supplements and life style. He also addressed the Cyclic Variations in Adaptive Conditioning™ (CVAC™) process as a means for reducing pain, how to use lymph therapy to improve lymph flow, and cardiovascular stiffness.

Dr. Winqvist completed an analysis of some aspects of the immune system in the blood of people with Dercum’s disease who have Type II, or widespread affected tissue with small nodules in the fat, by fluorescence assisted cell sorting (FACS).  He also wanted to examine the immune system in people with Type III, who have larger painful lipomas, often in the absence of obesity.

The patients with primarily Type III Dercum’s Disease who attended the meeting provided blood to Dr. Winqvist for further analyses. All of the people with Dercum’s disease shared their stories and found they had a lot in common. Many people noted their lipomas started after an infection or trauma.

FDRS helped to recruit people for this meeting and will continue to support research in all RADs across the globe.  We want to give special thanks to Staffan Erickson who worked tirelessly to encourage people to attend this meeting and Staffan’s girlfriend, Amielyn Garcia-Manzano, for taking pictures at the event.  We are grateful for Drs. Winqvist and Haglund and their continued interest in Dercum’s Disease and kudos to all the people who took the time to attend the meeting.

THE ROLE OF THE PRESIDENT

The President directs the organization toward achieving its mission: to raise funds to promote research, increase public awareness, and provide information and resources for individuals with rare adipose disorders (RADs) and/or their caregivers.  This is a highly visible position, and both an honor and a responsibility that requires stewardship of the organization’s mission, reputation and resources.  It involves a variety of larger scale projects and day-to-day activities.

The President of the FDRS will direct and coordinate with board and non-board members to:

• Raise funds to support research into treatements and cures for RADs.
• Reach out to the community with information about research, diagnosis and treatment options, and other topics related to RADs, including building/maintaining databases of patients, donors, doctors, researchers, and other affiliates to whom we communicate.
• Create working alliances with other RADs non-profit organizations.
• Advocate for funding and recognition for RADs, including applying for grants, when applicable.
• Host or sponsor scientific meetings and patient conferences
• Award grant monies for research into RADs

QUALIFICATIONS

The ideal candidate for this volunteer position should believe in the mission of FDRS, be able to help develop and oversee FDRS strategic goals, and be self-directed and organized.  Public speaking and interaction with outside businesses are required, as are strong communication and computer skills.  A minimum of a Bachelor’s Degree and experience running a business or a non-profit organization is highly desired.  The President must have the time and patience to work easily with a variety of personalities, including people with RADs, and will work with the FDRS secretary to keep a large group of geographically-dispersed individuals on-task.

I will, however, continue to serve on the board of FDRS as Treasurer.  I am hopeful that reducing my role on the board will allow me to contribute to FDRS at a level that better fits with my work life.  And before I leave the role of President, there are several big projects that I hope to complete for FDRS, to better position us for future growth.

Meanwhile, we are searching for a new President so that we can have a smooth transition by July.  We will be putting out a more detailed announcement about that shortly, along with announcements about other exciting positions we are adding to FDRS to help with development/fundraising, legal regulations and filings, and more.  We recently welcomed two new board members as well.  Dina Green is our new Secretary (the position formerly held by Jan Caise, who will be dedicating more time to patient support activities); , and Heidi Sykora is our new Vice President of Outreach and Education.  Heidi’s first big task is to lead the next conference, which is slated for April 2013.  We had some website troubles back in March and are continuing to restore complete functionality to our site, so you may have missed the news that Dr. Karen Herbst has assembled a talented Medical Advisory Board with the world’s leading researchers of RADs.  You can see the full list of medical advisors here.

This is an exciting time for FDRS.  This organization was launched in 2009 to find treatments and cures for Lipedema, Dercum’s Disease, Madelung’s Disease, and Familial Multiple Lipomatosis, as well as to raise awareness of those disorders.  We are only at the beginning of a long journey.  But you can make a huge impact, if you have the time and the talent to help lead FDRS as we continue this journey.

Thank you for allowing me the honor of serving the RAD community as President of FDRS for the past year and a half.

Sincerely,

Tina Tranfaglia

TinaTranfaglia@fatdisorders.org

More about Dr. Winqvist: Click here

Anyone with any type of Dercum’s disease is welcome at this informational meeting to learn more about Dercum’s disease. This is a great opportunity to increase education and awareness about Dercum’s disease and your quote may make it into the newspaper!

Please contact Staffan Eriksson for more information: staffaneriksson@spray.se

Staffan is willing to pick people up at the central station in Stockholm, or you can taxi to the Institute. Staffan will meet you outside the Institute and walk you to the lab.