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MDCC May 10, 2006 Meeting Minutes

Department of Health and Human Services
National Institutes of Health
Muscular Dystrophy Coordinating Committee

May 10, 2006
Summary of Meeting

The Interagency Muscular Dystrophy Coordinating Committee (MDCC) was convened for its fifth meeting on May 10, 2006 at the Gaithersburg Marriott Washingtonian Center, Gaithersburg, MD. Dr. Stephen Katz, Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), served as Chairperson and Dr. John Porter, Program Director, National Institute of Neurological Disorders and Stroke (NINDS) served as Executive Secretary. In accordance with Public Law 92-463, the entire meeting was held in open session.

I. Call to Order and Opening Remarks

Dr. Stephen Katz called the meeting to order at 8:45am. He welcomed the Committee members and noted that this committee facilitates coordination of muscular dystrophy programs across the federal agencies. The purpose of this meeting is to review what each agency is doing in response to the Action Plan for the Muscular Dystrophies. The Action Plan was drafted by a Scientific Working Group in August 2005 approved by the MDCC in December 2005. Dr. Katz welcomed public comments during the meeting, in accordance with the guidelines for FACA committees. Minutes of this meeting will be posted on the MDCC web site.

Dr. Landis and Dr. Alexander both expressed their appreciation to Committee members and applauded the MDCC's efforts. They mentioned the excellent collaborative relationship between the Institutes at NIH involved in muscular dystrophy.

Dr. Porter, Executive Secretary for the MDCC, reviewed the conflict of interest policies and procedures.

Committee and audience members briefly introduced themselves.

II. Overview of the Action Plan for the Muscular Dystrophies Process

Dr. John Porter presented a recap of the MDCC and the Action Plan for the Muscular Dystrophies. Dr. Porter stressed that the MDCC is a coordinating body and not a grant making or directive body. The Committee functions optimally with focused consensus goals to coordinate individual and collaborative efforts. The first step in the planning process was the Research and Education Plan for the National Institutes of Health (NIH). The second step is the Action Plan for the Muscular Dystrophies that spans the interests of the organizations on the MDCC.

The Scientific Working Group (SWG) that drafted the Action plan was charged with refining and focusing the major topics of the MDCC Research and Education Plan into specific Research Objectives for NIH and other agencies. The SWG also prioritized goals and identified obstacles to progress while focusing on high priority needs for all muscular dystrophy types.

The Action Plan for the Muscular Dystrophies focuses on the areas of 1) Disease Mechanisms, 2) Diagnosis and Screening, 3) Therapy, 4) Living with Muscular Dystrophy and 5) Research Infrastructure. The purpose of today's meeting is to gain a collective understanding of current activities and needs relative to the Action Plan. Future meetings will include follow up tracking of MDCC member activities to facilitate further individual and collaborative efforts in achievement of Action Plan objectives.

III. Senator Paul Wellstone Muscular Dystrophy CRCs and The Action Plan

Dr. Glen Nuckolls gave an update on the objectives of the Action Plan addressed by the Wellstone MD Centers Program. The Wellstone Muscular Dystrophy Cooperative Research Centers are authorized in the MD CARE Act of 2001 and are supported by three NIH Institutes (NINDS, NIAMS, and NICHD). The Muscular Dystrophy Association provides additional support to three of the Centers during their initial three years of existence. The six Wellstone Centers work together toward a common theme: accelerating the progress of advancement toward therapies for muscular dystrophy. Each Center coordinates efforts to help bring together investigators at multiple sites and the network increases interaction between investigators. Currently there are 31 projects across the centers, with the majority of these projects focused on developing therapies.

The University of Washington Wellstone Center, under the direction of Jeffrey S. Chamberlain, PhD, has ongoing activities in pre-clinical viral gene therapy studies for Duchenne Muscular Dystrophy (DMD) in mouse and dog model systems; studies of the molecular pathogenesis of myotonic dystrophy (DM1); a core facility to produce recombinant virus for gene therapy studies; and a diagnostic and genetic counseling core.

The Wellstone Center at the University of Rochester, directed by Richard T. Moxley, III, MD, is currently undertaking pathophysiology studies of DM and facioscapulohumeral Dystrophy (FSHD); a Phase I/II clinical trial of Somatokine (rhIGF-1/rhIGFBP-3) for safety and tolerability in DM1; a repository of transgenic mice, human tissue samples and cell lines for MD1 and FSHD; and a National Registry of DM and FSHD Patients and Family Members.

Joseph C. Glorioso, PhD, directs the Wellstone Center at the University of Pittsburgh. Current activities include clinical studies of gene therapy for LGMD 2D; translational studies of gene therapy in DMD dogs; muscle derived stem cell therapies; and core facilities for clinical AAV vector production, dog models of DMD, and biologic imaging.

The Wellstone Center at the University of Iowa is directed by Kevin P. Campbell, PhD. The Iowa Wellstone is focused on novel strategies for correcting cellular and molecular deficits in DMD; clinical and molecular studies of LGMD 2I; muscle progenitor cells derived from mouse embryoid bodies; and core facilities to develop diagnostic tools and to distribute tissue and cell based models of disease.

The University of Pennsylvania Wellstone Center, directed by H. Lee Sweeney, PhD, is studying potential therapeutic approaches to increase muscle growth (myostatin inhibition and IGF-1); protease inhibitors to decrease muscle degeneration and maintain muscle mass; Phase I/II clinical trials for safety and feasibility of Bowman-Birk Inhibitor Concentrate (BBIC) in DMD patients; and also has a core facility for physiological assessment of muscular dystrophy mouse models.

The Children's National Medical Center Wellstone Center, under the direction of Eric P. Hoffman, PhD, currently has activities in the following areas: genetic modifiers of DMD and patient response to glucocorticoid treatment; growth factor signaling pathways regulating muscle cell damage and growth; cellular mechanisms of muscle regeneration; and has core facilities for clinical research infrastructure (the Cooperative International Neuromuscular Research Group; CINRG) and bioinformatics. CINRG is supported by MDA, CDC, and the National Institute on Disability and Rehabilitation Research (NIDRR; Department of Education).

The Wellstone Centers participate in several collaborative activities that have applicability to the Action Plan objective to make resources more readily available to researchers. For example,, the Seattle Center collaborates with the Pittsburgh Center on the study of immune responses to viral gene delivery in MD dogs and with the Rochester Center on gene transfer studies in the DM1 mouse model.

Other collaborative activities among the Wellstone Centers include a "Wellstone Fellowship" program ( that provides opportunities among the Centers for training and career development through new collaborative projects led by young investigators. The Wellstone Muscular Dystrophy Workshops and Research Conference program ( is designed to be a series of small workshops, focusing on high priority topics in MD research. The workshops allow collaborations between Wellstone Centers and the research community. Support for this program is provided through competitive supplements to the Wellstone Centers. In April 2006, the Children's National Medical Center Wellstone Center sponsored the first of these Wellstone Conferences, a workshop entitled: "High-Throughput Screening in the Muscular Dystrophies." Mr. Perez asked if other dystrophies, specifically limb girdle and myotoic dystrophy, were represented at the workshop, and Dr. Nuckolls replied that other dystrophies were represented.

Dr. Katz remarked that the Wellstone Centers program builds on other muscular dystrophy research supported by NIH. Dr. Landis mentioned other NIH activities—including the Molecular Libraries initiative of the NIH Roadmap—that may be of interest to muscular dystrophy researchers. Dr. Katz stated that the challenge is communicating all of these opportunities to the scientific community, particularly opportunities that may be beyond those specifically targeted to muscular dystrophy, but thought that that the MDCC could play an important role in this effort. Dr. Hesterlee said that MDA tries to send out information as a mailing list once or twice a year

Mr. Perez raised two questions: 1) will there be any additions to ongoing Roadmap program announcements in relationship to MD and 2) whether there were any contingency plans in place to salvage the research should the Wellstone Centers dedicated to AAV research fail? Dr. Katz responded that some of the initiatives are currently available through the NIH Roadmap and this represents opportunities from the most fundamental science to translational possibilities across all diseases and disorders. Commenting on Mr. Perez's second question, Dr. Katz said that if any of the AAV efforts fail, there are alternative ways to approach this through stem cells or other types of vectors. Dr. Porter added that it is important not to invest in one specific strategy for therapy development, but to develop research across many areas in parallel.

IV. NICHD Activities and the Action Plan

Dr. R. Rodney Howell from the National Institute of Child Health and Human Development at NIH spoke on Newborn Screening for the Muscular Dystrophies: An NICHD Research Priority. The national newborn screening program dates back to the 1960's and is a process with many elements. It is state-based and therefore has intrinsic variability from state to state. Obtaining informed consent is not a usual activity in newborn screening. There are multiple stages to assessing the readiness for newborn screening including: 1) a preliminary phase demonstrating evidence of public need and the state of public preparedness; 2) feasibility of benefits, education, resource availability for care and follow-up; 3) pilot studies of economic aspects, sample issues, consent and follow-up; 4) initiation of public screening; and 5) ongoing evaluation and enhancement.

NICHD views newborn screening for MD as central to its scientific mission. This requires research across the spectrum of NICHD interests including basic biology, bio-behavioral, ethical, psychosocial and cultural, translational and public health importance. NICHD has been involved with the history of newborn screening research, including testing for PKU, hypothyroidism and galactosemia. NICHD also acknowledges that there are important aspects of behavioral and psychosocial research as well as ethical, legal and social implications of newborn screening.

There are many challenges and opportunities for newborn screening including the enormous number of potential targets and how to prioritize which conditions to screen (70% of states currently screen for at least 30 conditions). Additional challenges are seen with competing technologies, education of the public about the significance of screening results and the variability and complexity of individual state policies. NICHD is undertaking additional research efforts in newborn screening through development of research infrastructure plans; clinical trials of screening methods; clinical trials of therapies for screened conditions; and studies of long term outcomes of screening and treatment.

The Secretary's Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children is a Federal committee looking at newborn screening looking at efforts to increase materials. This committee consists of multiple agencies, organizations, professional and scientific bodies as well as parent representatives. They are currently considering what conditions are appropriate to be included in screening. MD is presently not included as therapeutic issues prohibit first line inclusion.

NICHD has special areas of research related to newborn screening for MD, including other non-muscle disorders in MD, as well as rehabilitation and family issues. The first proposal for newborn screening of DMD occurred in Iowa in 1971. The first major screening trial using CPK was conducted in Germany during the mid 1970's. There were mixed results from the German effort. Currently, the CDC is sponsoring an ongoing trial using multiple CPK tests. There are new proposals to use molecular genetic technologies such as DNA chips similar to the CF model. There are promising technologies on the horizon, but effective treatments need to be identified as the importance of earlier diagnosis and treatment is understood.

NICHD has several activities in the area of newborn screening for MD including: an RFP for novel screening technologies (; an RFA for new therapies for screenable disorders (; a Spinal Muscular Atrophy newborn screening supplement; and infrastructure and development planning for trials and informatics.

Dr. Brann asked if the RFA and RFP were for any genetic disorder. Dr. Howell replied that these announcements were not restricted to MD only.

Mr. Perez noted that NICHD has had very poor representation in the muscular dystrophies besides Duchenne. He questioned how will NICHD be active in diseases other than Duchenne? Mr. Perez also stated that NICHD does not have a strong presence in FSDH. Would newborn screening include a body of work around pre-natal screening of women with muscular dystrophy? Dr. Alexander noted that ideally there would be a newborn screen for anything that there is a gene for. Mr. Perez wondered if this would be genetic testing of material obtained during CVS or amniocentesis procedures. Dr. Alexander replied that current efforts at NICHD are focused on newborn/postnatal—not prenatal- testing. Dr. Howell stated that newborn screening is for any disorder that there is a gene and a benefit (broadly defined) for the family and children. Dr. Katz noted that there is a "benefit umbrella" that could range from family planning decisions to decisions about what type of house to purchase (1 story vs. two or three stories with stairs). Dr. Alexander stated that often these things are not thought of as benefits, but in reality they are. Dr. Howell stated that the committee would have to make a final decision on the benefits offered by screening, and would not include a condition for screening solely on these factors. Dr. Brann said that ethical considerations should percolate higher up the decision making tree. The first consideration should be if there is an available treatment, but there are other items families need to consider if a child has a genetic illness. Additionally, he pointed out that this is also based in state legislatures. Dr. Howell told the group that the federal government has no role in the state mandates, but states are adopting the federal report in response to advocates. Newborn screening is up to 70%, from 30% just two years ago. Dr. Katz asked Ms. Furlong to comment on these dimensions in the decision making of the states. Ms. Furlong noted that often families have three children before the diagnosis is made. Families could use this information to make informed decisions about housing, jobs and insurance. The ground is shifting from the attitude of "no treatment, no testing" to more reasonable parameters. She stated that there is and will be a need to educate families and conduct outreach on why and what the effects are on individuals and their families. Ms. Furlong thought that newborn testing would be well received. Dr. Howell noted that family receptivity to newborn screening has shown to improve with education.

V. NIH Activities and the Action Plan

Dr. John Porter discussed the Action Plan and it's relevance to NIH. He stated that this presentation describes work that is not yet completed - this is an overview of where things stand at the moment.

In fiscal year 2005, several NIH institutes including NIAMS, NINDS, NICHD, NCRR, NIA, NHLBI, NHGRI and NINR have projects coded as muscular dystrophy totaling 39.5 million dollars. This figure represents funding that is payline-driven, that is, there is no specific set aside for MD. Instead the amount of NIH support for any one disease is driven by how competitive the applications are in the pool of those submitted by investigators. This system has been highly successful in: 1) ensuring that the highest caliber science is supported through NIH grants and 2) producing dramatic advances in health care and quality of life. All applications submitted to the NIH are subject to two levels of review: 1) peer review and 2) institute advisory councils. Dr. Katz noted that applications beyond the payline can be paid through various mechanisms. NIH Program Directors are important advisors to the Institute Directors in relaying where research priorities lie.

Mr. Decker inquired if there was a difference between FY 2005 and FY 2006 funding levels for MD. Dr. Porter replied that the FY 2006 numbers are not in yet. Coding for any fiscal year is not reported until the following December or January.

Dr. Porter continued his presentation on NIH activities regarding the Action Plan. He noted the Wellstone Centers are the cornerstone of MD dollars and represent approximately 25% of the NIH funding level for MD. However, there is much more activity in MD than just the Wellstone Centers. Support for research in MD comes from "unsolicited" research grant applications (i.e., those not in response to a specific program announcement), as well as program projects, training and career development awards, contracts, Requests for Applications (RFA), Program Announcements with Set-Aside (PAS), Program Announcements with Special Review (PAR), Program Announcements (PA), and various activities in the NIH Roadmap and Blueprint.

The NIH Roadmap includes multiple activities with relevance to MD, including the high throughput screening centers, screening assay development grants, and the molecular libraries program, wherein if a compound does not work for one disease, it may have activity in another disease. There is a potential partnership opportunity between the Roadmap activities and the DoD-funded screening program for MD at the University of California at Los Angeles. Additional partner opportunities can be leveraged through the Roadmap RAID program and academia. Microarray centers from the NIH Blueprint, a neuroscience initiative, offer the ability to run microarray assays at cost.

Important points to consider related to the potential success for therapeutic development in MD have been borrowed from industry and include: 1) therapeutics that are linked to disease mechanism; 2) patients readily diagnosed at sufficiently early stage of disease; 3) disease amenable to palliative or curative therapy; 4) clinical trials feasibility; and 5) chronic diseases are easier to target than acute diseases. In the case of MD, all agencies should think about their research/therapeutic development undertakings and link therapies to these points.

Link therapeutic development efforts to the disease mechanism: There often needs to be an understanding of the mechanism before a therapy can be developed. Investigators generally identify a mutation and the mechanism is understood before a therapy is developed—at this point, industry would not proceed with therapeutic development unless they have a targetable mechanism. Secondary disease mechanisms can be effective targets—such as the current Wyeth trial using myostatin inhibition to maintain muscle mass in Becker, limb girdle, and FSH muscular dystrophy. To better understand the primary mechanisms of the muscular dystrophies, and thereby develop more effective therapeutic targets, the NIH has released initiatives specifically soliciting mechanistic grant applications in the muscular dystrophies.

Patients diagnosed at a sufficiently early stage of disease: A variety of diagnostic tools are available to establish the MD diagnosis. These include non-invasive testing, validation of genetic tests (sensitivity and specificity), along with resources related to diagnostics - screening data bases, registries, muscle imaging in diagnostics, epidemiology and neonatal testing (NICHD). The specificity of diagnosis does not appear to be a major hurdle for therapeutic development in the MDs.

Remaining items on the list include: disease amenable to therapy, the feasibility of clinical trials, and chronic diseases more easily targeted than acute onset. Proof of principle has been established for the responsiveness of MD to therapies, clinical trial networks to facilitate trials have evolved (CINRG and Muscle Study Group), and all of the MDs are chronic.

Overall, the criteria for a successful therapeutic development program either are in place or are being carefully addressed for the MDs. A variety of therapeutic targets are being explored.

Ms. Furlong interjected that the advocacy community wants a choice of therapies for their affected family members, and mentioned the deflazacort vs. prednisone study as an example. However, deflazacort is not available in the United States. Dr. Porter noted that this study is international and the US sites are offering both the deflazacort and prednisone arms to study subjects. NINDS can accept additional clinical trial applications through the planning grant mechanism. The planning grant is used to put together a study protocol and research group prior to submitting the full application to NINDS. Applications of interest to date have focused on growth factor modulation, gene repair, gentamycin trial, exon skipping, high throughput screening, translational research and cardiopulmonary care.

NIH is responsive to the Living with Muscular Dystrophy section of the Action Plan through projects focusing on rehabilitation. Many of these lie within NICHD.

Research Infrastructure support is offered through preclinical and clinical communication and education efforts (Wellstone Centers and the MDCC website) as a source of information for the community and researchers. NIH also supports training of new investigators through F and K mechanism initiatives in muscle disease. There is a new training mechanism (K99/R00) that supports new investigators who are transitioning from fellowship training to functioning as independent researchers.

The MD Action Plan is an important component in NIH planning and advising. The Action Plan has contributed to new NIH initiatives including the Wellstone Muscular Dystrophy Workshops and Research Conference program (; Infrastructure), PARs on Translational Research in Muscular Dystrophy (; Therapy) and RFAs done in partnership between the NIH and the MDA on Nuclear Structure-Function Defects in the Pathogenesis of Muscular Dystrophy ( and; Mechanisms). The Action Plan is also a tool for advising trainees and new investigators as to potential research directions. It is also included as a factor in discussion with potential applicants on the applicability of the NIH Roadmap and Blueprint initiatives.

Mr. Decker asked if there was any ongoing research in the area of adult stem cells. Dr. Katz replied that there was recently a retreat that had an interest in stem cells (Stem Cell RFA Grantees Meeting, April 26-28, 2006). Dr. Nuckolls expanded on the content of the retreat by stating that subpopulations of post natal muscle tissue related to satellite cells that have the capacity to differentiate into muscle tissue have been identified. Mr. Decker emphasized that patients who want to volunteer to donate adult stem cells should be able to do so.

Mr. Stephenson remarked from the patient advocate viewpoint that he represents thousands of patients across the world. He also noted that NIH funding for MD decreased from FY 2005 to FY 2006, and he feels that this is heading in the wrong direction. If institutes can go beyond the payline, why has MD been historically underfunded? He suggested that institutes need to internally adjust their budget so funding levels for MD can increase. MD is a specifically deadly disease, and particularly DMD. Other diseases such as arthritis are disabling, but not as deadly. MD is the cause of death of many children and adolescents, and MD has a special place in the hearts of many Americans due to Jerry Lewis and the MDA. Mr. Stephenson encouraged the NIH institutes themselves to use MD to advocate for more funding.

Dr. Katz agreed that applications can be paid beyond the payline, but he stated that the major driver setting NIH funding is the science. NIH does not set a dollar amount before the outset of any fiscal year and instruct institutes to spend those finds on any particular disease or disorder. If this is done, it will denigrate the science behind the research. He stressed the value of the Peer Review system. Advisory councils then look at the applications driven by the science. NIH should not set it's priorities by death. No one wants to put themselves in the situation of having a child with MD, but if priority setting is done by death, that would set all other areas that NIH is concerned with, including those with a social component (drug abuse, alcoholism), aside. It is important to know that NIH does not set priorities by any one measure.

Mr. Stephenson responded that he's aware of the progress that has been made with the committee over the years, but it is important for institute directors to be aware of the advocacy community feeling that MD is under-funded.

Dr. Landis raised the point of not looking at the 2006 and 2007 estimates as budgets per se—more money could be spent on MD provided there are more meritorious applications. She hoped that the Action Plan would help encourage additional applications in MD.

Dr. Katz stated that NIH funding continues to be a tension point in the MDCC meetings and it is important that the community keep bringing it up. Mr. Stephenson said that he is obligated to share his thoughts from the patient perspective.

Mr. Tingus added additional comments to Dr.'s Landis and Katz' remarks by saying that NIH is a federal agency and there must be a recognition of bureaucracy and priority setting and realizing there is a dilemma between what you would like to do and what you can get done. As a person with MD, Mr. Tingus can focus on the science and recommends to the advocacy community that it is all up to them to tell Congress where the resources need to be allocated. As a federal employee, individuals in the system cannot do that, and this is a common misunderstanding. NIH and other federal granting agencies can only run programs and rely on peer reviewers to present the best proposals.

Mr. Tingus directed a question at Dr. Hesterlee regarding how the Memo of Understanding (MOU) between NIH and the MDA came about for the Wellstone Centers. Dr. Hesterlee replied that MDA spoke with NINDS after the MD CARE Act and MDA now provides supplemental funding to three of the Wellstone Centers.

Dr. Katz reinforced the importance of the common goal of leveraging relationships between public/private partnerships through Memoranda of Understanding. The goal would be to reduce redundancy to ensure that partnerships are truly leveraging resources and making research dollars go even further.

Dr. Porter highlighted a current NINDS initiative that includes the MDA as a funding partner. This is the initiative entitled: Nuclear Structure-Function Defects in the Pathogenesis of Muscular Dystrophy ( and NIH makes the initial funding decisions, but for meritorious applications not chosen for funding by NIH, MDA will consider funding if the investigator forwards copies of the application and NIH review to MDA.

VI. CDC and the Action Plan

Dr. Edward Brann began by mentioning that CDC has recently developed a strategic plan for muscular dystrophy and was hopeful that this represented opportunities for integration with the MDCC's Action Plan. He also explained that NIH and CDC are funded very differently: CDC funding is much more Congressionally-directed, giving CDC less discretion and flexibility than NIH. Most of CDC's money is directed to projects on DMD/Becker. He then went on to highlight the activities of the CDC relevant to the Action Plan. Relevant to the Diagnosis and Screening goals within the Action Plan, the CDC funds a number of epidemiology studies based on genetic diagnosis of muscular dystrophy. The MD STAR NET is now in five states and has developed a surveillance and tracking research network for Duchenne MD. Laboratory quality assurance is available as a resource for the research community as well as screening programs for newborn and early infancy testing. Screening is done at two different ages (newborn and at 15 months when the child returns to the pediatrician). These two time points were chosen based on discussions with a large group on ethical and practical issues.

Another area of focus for CDC relevant to the Action Plan is the Living with Muscular Dystrophy section. CDC is involved in quality of life measures in muscular dystrophy through several projects including The National Initiative for Families with Duchenne (NIFD), coordinated through the CINRG network, and the Needs of Families and Patients with Muscular Dystrophy (NFPMD), coordinated through STAR NET. As part of the MD STAR NET program in Iowa, CDC is addressing the palliative care and hospice needs of children with DMD. CDC is also addressing specific health care issues for Hispanic families with DMD as well as planning a best practices conference to develop consensus guidelines for the clinical management of Duchenne and Becker Muscular Dystrophy.

Lastly, the CDC is working in the Infrastructure area of the Action Plan by focusing on communication and education of cardiac care in female carriers of DMD. They are also partnering on work with a single gene resource center (Genetic Alliance) and a Parent Project Muscular Dystrophy (PPMD) outreach project.

Dr. Katz commented that the CDC contributions to the entire muscular dystrophy effort are critical. He noted that there is little overlap with the current programs being directed by other agencies and that the CDC activities are tremendously complementary. It appears that the community takes full advantage of CDC opportunities, but he wondered how the advocates and CDC integrate.

Mr. Perez had a question relating to the MD STAR NET surveillance program. He asked how many boys had been added to the registry since there has been $8 to $10 million spent on this project over the last 4 to 5 years. Dr. Brann responded to the cost effectiveness of the surveillance program by saying that the first report of how many patients have been enrolled will be available shortly. Dr. Katz supported this statement and added that although the surveillance program appears expensive now, it is an early expense and will not be duplicated later on as definitional challenges and validation of cases was included as an early part of the investment. Expenses in these areas will not be as great as the project moves on.

Mr. Perez then noted that the CDC had issued an RFA over electronic medium but the turnaround time offered to applicants was only 7 days. He said that this was typical of Congress to include Duchenne only and that not enough time was allowed to bring other diseases in. He also remarked that Native Americans were underrepresented in the RFA, but felt it especially important that the Committee knows that this was due to a very short turn around time.

Dr. Brann explained that this announcement was a restricted competition for the continuation of a current project and this is the way CDC manages its announcements. He acknowledged that the 7 day turn around time is a problem, but that it is due to budgetary and procurement issues in the grants office of CDC. Program officials in CDC are given the timelines without a vote in the process. Dr. Katz added that issuing announcements is a much greater challenge to CDC and their process cannot be compared to NIH.

Ms. Furlong and Dr. Hesterlee also noted that their organizations would not be able to turn around applications given the extremely short time frame in which to respond. Dr. Brann stated that this announcement came as authorizing language, but will continue to accept comments on the short turn around time and will pass those comments along to CDC.

VII. FSH Society Activities and the Action Plan

Mr. Daniel Perez thanked Dr.'s Katz and Porter for the Action Plan in Muscular Dystrophy and commended the MDCC for their extraordinary effort. The FSH Society encourages and promotes scientific and clinical research and development into the causes, alleviation of suffering, treatment and cure of FSHD. The FSH Society is limited only by financial restrictions and not by people or insight. Through research objectives and various activities, the FSH Society is focused on mechanisms of muscular dystrophy, diagnosis and screening, technology of diagnostic testing, muscle imaging, genetic screening and neonatal testing. Peer review critiques research applications and the Society is involved in networking researchers, patients and agencies. Therapy of muscular dystrophy research objectives include assessment of steroids and growth factors, high throughput screening and translational research facilitation by providing information and data to clinical researchers.

Dr. Katz inquired whether the FSH Society has actually funded clinical studies. Mr. Perez replied yes. The Liverpool study looking at creatine in neuromuscular diseases was given as an example. On a larger scale, the FSH Society provided Dr. Kathy Wagner of Johns Hopkins a list of all patients with specific criteria for the myostatin trial. The FSH Society does not have resources to fund that kind of a trial, but they will do small pilot studies in different areas.

Mr. Perez continued with his presentation on Living with MD and FSH Society activities related to quality of life, clinical endpoints in natural history studies and trials, consensus guidelines for the clinical management of MD, benefits and risks of exercise through promoting knowledge about living with FSHD. Through chapter bulletin boards, individuals can discuss what a patient with FSHD goes through as well as access a data base of drugs that are detrimental to pulmonary function.

Regarding research infrastructure needs, the FSH Society offers its full resources as a volunteer health agency dedicated to FSHD and educates the general public to raise awareness of what MD is. The Society also offers preclinical research infrastructure as well as clinical research and trial infrastructure communication and education.

In conclusion, Mr. Perez reminded the MDCC to consider that FSHD is the second most prevalent muscular dystrophy. The Committee and the public need to understand that there are more people with FSHD and Myotonic Dystrophy than Duchenne. FSHD is not a small and rare entity, but larger than Duchenne.

Dr. Katz followed up on Mr. Perez' presentation by noting the need for more partnership between the government and the private sector. In the future, each organization will be asked for details on contributions and will be recognized in the Action Plan. The prevalence of the various dystrophies has been a topic of much discussion among the various advocacy groups, but Dr. Katz reminded the group that there is no set aside for specific diseases. If the science drives it, it will grow. From the NIH standpoint, it is not a matter of competition between applicants for a finite amount of dollars, : If the science drives it, it will grow. Dr. Porter noted that NIH recognizes that there is a gap in the dystrophies being studied and acknowledged that FSHD is an understudied dystrophy. He also said that there have been solid mechanistic publications in the last year and a half, so the time is right for NIH to do something in this field. He highlighted an initiative recently issued by NIH, in partnership with the MDA, on the less studied dystrophies (i.e., the two RFAs on Nuclear Structure-Function Defects in the Pathogenesis of Muscular Dystrophy), which will hopefully stimulate the field.

VIII. MDA Activities and the Action Plan

Dr. Sharon Hesterlee presented a portfolio analysis of what MDA is funding in the different categories of the Action Plan. Currently, MDA has 200 funded grants in the area of MD for 3 years or less. The average cost of an award is $100,000 per year. Treatment strategies represent the largest portion of these awards, and screening and diagnosis the fewest. Work has been done on screening and diagnosis in the past, however. Treatment strategy work is currently concentrated in cell based therapies, including adult derived stem cells, gene therapy studies, pharmacological treatments and muscle regeneration. The second largest funding area is mechanisms of disease with the majority of grants focused on protein deficiencies. One grant each is being funded in the areas of Living with Muscular Dystrophy (looking at the duration of assistive technology) and Research Infrastructure (access to a monoclonal antibody collection in the UK on a fee for service basis subsidized by the MDA). MDA finds it difficult to fund infrastructure grants. There must be a need demonstrated by the community for infrastructure funding.

MDA also organizes patient networks and is establishing the North American Neuromuscular Disease Working Group. The goal is to make this a national DMD clinical research network, but there is disagreement whether networks should be project or infrastructure driven and there is a lack of sponsorship for the current activity. . This network would make it possible for more people with MD to participate in clinical trials. MDA is also partnering with pharmaceutical companies to see what the community can do to speed up drug development. A publication from the challenges in drug development meeting held in August 2005 is forthcoming. MDA has future plans to issue an RFA for exon skipping and an ACE inhibitor trial for cardiomyopathy.

MDA has a translational research program that overlaps with the MDCC plan.

IX. PPMD Activities and the Action Plan

Ms. Patricia Furlong presented the activities of the Parent Project Muscular Dystrophy to the Committee. PPMD's mission is to improve the treatment, quality of life and long-term outlook for all individuals affected by Duchenne Muscular Dystrophy through research, advocacy, education and compassion. Their interest is in looking at near term options that are high risk, but high reward, with a translational focus.

In 2005, PPMD held a conference on anti-inflammatory use in MD. They are also supporting research in anti-sense oligonucleotides with the prospect of transforming DMD into a Becker-type dystrophy. PPMD will pool their funding with MDA and NIH to look at specific areas of interest in anti-sense research through the Duchenne Translational Research Consortium (DTReC).

PPMD has partnered with PTC Therapeutics in a drug discovery program, called Project Catalyst. PPMD has supported PTC Therapeutics and the development of PTC124 with $2 million to date. PPMD also supports infrastructure and core facilities at the University of Missouri and the University of Pennsylvania.

In the Action Plan area of Diagnosis and Screening, PPMD is working with the University of Utah Sequencing Core and the Dystrophinopathy Group comprised of the University of Iowan, Cincinnati Children's Hospital Medical Center and the University of Utah.

PPMD is working to establish and disseminate standard of care guidelines for cardiac care in patients with DMD. Comprehensive heart failure therapy can be applied to DMD and should be followed for all patients. Ms. Furlong reminded the group about the importance of cardiac care in DMD patients, as "your heart is a muscle, too!"

The "Live IT" activities of PPMD have resulted in the development of tools for families and health care providers as care varies across the country and around the world. PPMD Live IT tools include a DVD on care and management, "Laura's Choice" reproductive options, a stretching CD, "Brainpop" activities for children and Education Matters addressing practical issues for children who are disabled. "The Clumsy Campaign" was designed to create awareness and interest in muscle weakness. These activities help PPMD reach out to under-represented and underserved areas. Additional outreach activities include an annual conference where parents and physicians interact with each other and with UPPMD (, providing worldwide outreach.

Behavioral issues in MD are also addressed by PPMD. Anxiety, depression, social problems and autistic spectrum disorders can be seen as primary or secondary effects of DMD or treatment. PPMD is working to improve care throughout the US by partnering with CDC, MDA and others to develop a consensus statement that will improve the lives of children and adults.

Mr. Stephenson asked to what degree do the patient organizations coordinate and if they meet or coordinate outside of the MDCC meeting.

Mr. Perez replied that following the authorization of the MD CARE Act, MDA and the FSH Society have an excellent working relationship. However, PPMD and FSH Society both have well-organized lobbies, but very little direct interactions. He noted that this is in part due to the fact that PPMD's interests are DMD-focused and are cure and therapy oriented. The scientific momentum in FSHD is not the same as for DMD, and so the FSH Society is more focused on the mechanisms of the disease. The FSH Society extended an open hand to PPMD, and hoped there would be more opportunities for interaction..

Ms. Furlong responded that PPDM specifically represents Duchenne and Becker patients, but their work has a ripple effect throughout the community. PPMD has an ongoing relationship with MDA and they hold open conferences. Additionally, they work with FED, Cure Duchenne, Charley's Fund - all of whom hold open workshops as well. PPMD tries to be collaborative in all their activities and they welcome additional opportunities to collaborate. PPMD funds small projects hoping to get them into the realm of NIH or industry. PPMD wants to be collaborative, however the focus of the group is Duchenne MD.

Dr. Hesterlee remarked that the level of collaboration and cooperation of the voluntaries has grown over the past years. She noted that everyone came together to be at the MDCC meeting today, and the MD CARE Act has encouraged this interaction. The MDA does not hold any formal meetings with other voluntaries, but they have frequent, informal discussions with a high level of coordination.

Dr. Katz said that NIH deals with many different groups and knows that four or five organizations can be focused on the exact same disease process with no communication between the groups. The MDCC is unique in that there is a forum for open discussion provided for groups with different areas of interest.

X. DOD CDMRP Activities and the Action Plan

Capt. Melissa Kaime of the DOD presented the DOD's efforts in translational research in MD to the group. The DOD has activities in breast and prostate cancer, and other biomedical research including neurofibromatosis and osteoporosis. DOD receives its funding every year on Congressional direction. DOD funding is "seed money" only and does not allow for continuation funding. Congress instructs DOD where the funding will go and occasionally sets the research agenda. Unlike NIH, DOD research is not openly competed. From FY 2003 to the present, DOD has received $21 million in appropriations for research in muscular dystrophy.

Dr. Katz noted that the federal government wants to be as synergistic as it can and to keep redundancies to a bare minimum. By bringing all of the agencies to this meeting, the MDCC is encouraging this synergy. The exchange of ideas and people allows this to be done even better.

Capt. Kaime continued with her presentation by describing some of the projects that have been funded through the DOD dating back to FY 2003. MD researchers receiving DOD funding include Johnny Huard, PhD (FY 2003 "Advanced Technology Based on Adult-Derived Muscle Stem Cells to Enhance Muscle Regeneration and Repair"; FY 2004 "New Advanced Technology for Muscular Dystrophy"; and FY 2005 "New Advances in Molecular Therapy for Muscle Repair after Diseases and Injuries"), Timothy Koh, PhD, (FY 2004 "Enhancement of Skeletal Muscle Repair by the Urokinase-Type Plasminogen Activator System"), Kevin Campbell, PhD, (FY 2004 "Muscle Cell Maintenance and Repair"), Paula Clemens, MD, (FY 2003 "PITT 0503: Clinical Trial of Coenzyme Q10 and Prednisone in Duchenne Muscular Dystrophy"), and Eric Hoffman, PhD, (FY 2003 "Muscle Damage, Muscle Atrophy, Remodeling, Data Warehouse, Public Access"; and FY 2005 "Duchenne Muscular Dystrophy Translational Research Program"). Many of these projects incorporate different investigators at different institutions and Dr. Huard's FY05 award extended the number of investigators involved, along with the scope of work. These projects represent work in the areas of the Action Plan including Mechanisms of Muscular Dystrophy, Therapy of Muscular Dystrophy, and Research Infrastructure Needs for Muscular Dystrophy.

Dr. Katz pointed out the tremendous overlap in terms of investigator names that had been mentioned throughout the course of the day. He said that Capt. Kaime's presentation reinforced the importance of coordination of efforts and the need to be fastidious in minimizing overlap in the research field.

Dr. Alexander requested a clarification of how the DOD funds are received by the investigators. Capt. Kaime replied that the funding is from one to five years, and it is disbursed over quarters. Dr. Alexander wondered if DOD were funding new projects all the time. Capt. Kaime said that the DOD needs to review the statement of work to see how new the projects are, but some look new and different. Dr. Wilberding interjected that investigators are allowed to continue their work or submit new proposals, but that a complete budget needs to be included along with percent effort on all activities listed. Dr. Hesterlee said that with the redundancy of names in the research field, she is less concerned about double dipping, but wondering if the researchers are spread too thin. The group agreed that productivity will be the final outcome.

Mr. Decker voiced concern about the need to support the MD dog colonies and added that he has been talking to Congress about this.

XI. Department of Education NIDRR Activities and the Action Plan

Mr. Steven Tingus provided an overview of the National Institute on Disability and Rehabilitation Research (NIDRR). NIDRR is in the Office of Special Education and Rehabilitative Services (OSERS) in the Department of Education. NIDRR's statutory charge is to support research to maximize the self-sufficiency of individuals with disabilities of all ages. This includes youth through the senior population. More people are living longer with disabilities and are also aging into disability.

NIDRR's mission statement is: "To generate new knowledge and to promote its effective use to improve the abilities of individuals with disabilities to perform activities of their choice in the community; and to expand society's capacity to provide full opportunities and accommodations for its citizens with disabilities." This mission statement has been recently revised to emphasize the abilities of these individuals within their community.

The scope of the NIDRR mandate is across disabilities (sensory, physical, motor, cognitive and psychiatric disabilities) and across the life-span (children and youth, working age adults and individuals aging with a lifelong or early onset disability and those who are aging into disability in mid to later life). A mini-conference on aging was held at the White House in December.

NIDRR focuses on the whole person interacting with the environment and society. NIDRR's strategic goals are 1) to advance knowledge through research and related activities; 2) to advance knowledge through capacity building; and 3) to advance knowledge through translation by utilizing science-based knowledge, technologies and applications.

NIDRR focuses on employment, participation and community living, health and function, technology for access and function, and disability demographics. The Rehabilitation Research and Training Center in Neuromuscular Diseases (RRTC/NMD) at the University of California, Davis is NIDRR's largest research program in MD. It is funded for 5 years at $800,000 per year. This project develops programs for multi-center rehabilitation research through CIINRG. The RRTC/NMD was recently highlighted on the Jim Lehrer news hour. More information on the program can be found on the website

NIDRR is preparing to evaluate its FY 2008 activities. The neuromuscular priorities will be redeveloped but will not duplicate any other Federal efforts. In the near future, NIDRR will focus on more on quality of life issues and support for patients and families.

Dr. Katz stated that the research center at UC Davis supports a lot of fundamental work in the area of rehabilitation. He wondered if there were any other areas supported in MD. Mr. Tingus replied that there currently are no other efforts supporting neuromuscular disease or MD, other than Multiple Sclerosis. NIDRR has a large financial commitment to this center and the dollars can be stretched only so far. He added that the research that is funded is related to political support by the administration and also depends on feedback from the community as well as by the quality of applications that are received. Dr. Katz commented that the interaction between NIH and NIDRR was significant. Mr. Tingus said the NIH and NIDRR do work closely together and hopefully the collaboration will continue further as the populations they serve are so interrelated. He said that they are working to build a stronger bridge between the two agencies.

Dr. Katz said that the UC Center deals with many aspects of the Action Plan. Mr. Tingus said that there had once been basic science work on the mdx mouse at the Center, but there was a need to make the research more immediate, so the focus turned to nutrition, exercise, community involvement and support for parents and families. Dr. Jaeger added that there is a memorandum of understanding and an intra-agency agreement with the physical disability branch of the clinical center of NIH demonstrating the amount of communication between NIDRR and NIH.

Mr. Perez commented that he had served on the UC Davis committee. Mr. Stephenson wished to know how many MD patients were seen at the Center, what types of MD do they have and what are they doing with the patients? Mr. Tingus replied that patients with Duchenne, FSH, and Limb Girdle are seen. The Center serves Northern California to the Oregon border down to Fresno. Additional questions may be directed to the Center's Director of Research, Ted Abresch at 530.752.2903.

Dr. Morrissey from the Administration on Children and Families (ACF) made three points: 1) the Administration on Developmental Disabilities does not focus on MD specifically, but has universities with grantees in MD. For example, a film about young people with MD is being made at the University of Georgia. The video will be used to orient parents on living with MD; 2) there is a network of 180 grantees focusing on people with developmental disabilities including MD. They will be glad to partner and put information out to consumers; and 3) relates to the information piece on the consumer side.

Dr. Morrissey mentioned that there will be a conference held on June 28 - 30 on emergency preparedness for people with disabilities and the aged. It is sponsored by the Secretaries of DHHS and DHS and directed to state governors. The conference will focus on emergency management of aging and disability. The conference will be by invitation only and is the first conference of its kind. It will be useful to have representation on the consumer side of MD, but there will only be 50 seats at the conference. This is an issue that requires a great deal of consumer input.

Mr. Tingus added that NIDRR is taking the lead on two research initiatives, one on emergency preparedness and the other in pain management outcomes. These initiatives will be released in 2007 or 2008 and are looking at individuals with chronic diseases.

Mr. Stephenson asked if the film is a documentary. Dr. Morrissey replied that it was. Ms. Furlong had additional information about the video. She said it is called "Darius Goes West" and is about a boy with MD whose classmates decide he should take a road trip across the country. From Ms. Furlong's point of view, it looks like a piece about including people with disabilities and supports the messages "if there's a will, there's a way" and "we are all the same."

Mr. Perez inquired about Medicare and Medicaid and issues with ventilation equipment. He stated that recent changes to policy require the patient to buy the equipment and the vendor is no longer covered to go into the home so the equipment cannot be maintained. He was hoping to discuss this with CMS at this meeting, noting that working people often cannot cover the cost of wheelchairs. Ms. Furlong recommended seeking private funding to assist. She said that she knows of two foundations who serve individual needs. Mr. Perez cited countries like Canada and Sweden where new wheelchairs are provided to patients every five years. He said that the US Government should do more for its population since there are more needs that go unmet in the US.

Dr. Katz also said that CMS needs to be at the MDCC table. Dr. Porter replied that the MDCC needs a CMS nominee. Dr. Katz said that they would work to get a representative on the Committee.

Dr. Katz invited comments from the audience members.

Dr. Penn stated that the DOD presentation brought to mind what is being done about training and career development with new investigators in muscle disease. Dr. Nuckolls also voiced a concern for the need of a pipeline of well trained new investigators. NIH currently has an F32 announcement in muscle disease as well as K08 and K23 career development mechanisms that would support a new investigator for three to five years, depending on the awarding institute. He noted that the number of clinical investigators in MD is slim, and he would like to see more of them. There have been no applications received by NIAMS for the K23 announcement in over 5 years, and there is only one active career development award in MD at NIH. The Wellstone Centers also offer opportunities for mentoring trainees.

Dr. Hesterlee brought the conversation back to training new investigators in MD. She said that the training opportunities for MD investigators available through MDA are intended to be used for clinical research training. This program offers hands on work in clinical trials and guidance in patient record analysis. It is not meant for bench researchers. Applicants must demonstrate that they will take courses as well, and most applicants are in MPH programs simultaneously.

Dr. Porter noted that there are very senior investigators doing a lot of trials. He posed the question of solving the problem of the lack of junior investigators and suggested Dr. Birch Griggs attend a future MDCC meeting to discuss the lack of junior investigator involvement in clinical trials.

Dr. Katz said that PhD scientists in MD research are singularly effective in thinking about the patients - more so than in other fields. Leading efforts for therapeutics can come from PhD researchers, too. The MDCC should focus on the next generation of researchers at the next meeting.

Dr. Gutmann told the group that the American Academy of Neurology has an initiative to begin clinical research training fellowships in an effort to produce more clinical researchers. The community is also aware of this problem and the clinical community needs to be an active participant in resolving it.

Dr. Katz suggested that perhaps someone from the Academy would also be willing to address the MDCC about their particular efforts.

Mr. Perez thought that Birch Griggs and Ted Abresch would be excellent choices to invite to the next MDCC meeting.

Dr. Gutmann added that she felt residency programs do not emphasize research opportunities to their students. There is a need to increase awareness and open the discussion to allow more individuals to become involved.

Dr. Katz also mentioned the importance of professional organizations with educational sessions at their professional society meetings.

Ms. Furlong said PPMD has fellowship money set aside to give incentives to younger researchers through better salaries. She suggested a pooling of funding to increase salary support.

Dr. Katz said that NIH cannot solicit partnerships, but perhaps could draft a memorandum of understanding that would allow fellowships to receive salary supplementation from different foundations. With such an MOU, fellowships can be supplemented from other sources by up to $30,000 per year over what the fellowship stipend is without any indirect costs. He underscored the clear need for people who understand how to do clinical studies.

Mr. Stephenson expressed his concern regarding the lack of participation by FDA on the MDCC. This is a real issue to patients, as FDA has the power to stop studies. FDA simply provided information to be placed in the meeting binder from their web site and is not participating in this forum.

Dr. Katz has the same concerns and he will transmit the message.

Dr. Hesterlee asked "What next?"

Dr. Katz said that NIH will be putting the results of this meeting together and the MDCC will come together again to address the gaps identified in this meeting. Gaps could be filled by patient groups, agencies not represented here today and agencies presently at the table.

Training was identified as a gap to focus on for the next meeting. It appears that there is proactive activity, but with not much response. What is the commitment to training from all the organizations? The MDCC must look at the grid and evaluate where they are and where they will go. This will be a dynamic and ongoing process for the MDCC Action Plan.

Dr. Porter stated that the overriding goal is to get the plan implemented. The MDCC Action Plan is posted on the web. Today's meeting was to understand what is being done in response to the plan. The Committee meetings are an opportunity to be as transparent as possible, to get materials from members, put information on the website relative to each agency's mission and link them to the plan so everyone can see what is happening. Dr. Porter will be asking for this information from everyone. The Committee is about communication and collaboration for the community. Future meeting ideas are welcome. Current ideas might include a mini-symposia on regulatory issues; professional organization representatives; training and practice parameters. Dr. Porter encouraged Committee members to give him suggestions for important topics to be discussed.

Dr. Katz stressed that the interagency discussion will continue.

Dr. Hesterlee noted that today's presentations highlighted how much of the plan is already covered. She was impressed with the breadth and depth of the presentations and how much work is being supported relevant to the goals of the Action Plan.

Dr. Katz reminded the group that basic research also impacts in areas beyond the laboratory.

Mr. Decker inquired again if the government was doing any research on adult stem cells. He specifically wanted to know how to get this area jump-started if individuals who have a specific gene or disease want to donate their cells. Dr. Katz replied that this is a self-correcting scientific process. There is work being done in adult stem cells from muscle and differentiating into muscle. All investigators look to the human condition ultimately.

This being the end of the discussion, the meeting was adjourned at 3:20pm.

I certify that, to the best of my knowledge, the attachment and above minutes are accurate and complete.

Stephen I. Katz, MD, PhD
Chairperson, Muscular Dystrophy Coordinating Committee
Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases

Date: _______________


MDCC Members:

Duane F. Alexander - NICHD, NIH

Edward A. Brann - CDC

Donavan R. Decker - Patient Advocate

Patricia A. Furlong - Parent Project MD

Melissa Kaime - CDMRP, Department of Defense

Stephen I. Katz - NIAMS, NIH, Chair, MDCC

Story C. Landis - NINDS, NIH

Pat Morrissey - Administration on Developmental Disabilities, ACF

Daniel P. Perez - FSH Society (via phone)

Steven J. Tingus - NIDRR, Department of Education

Bradley R. Stephenson - Patient Advocate

Sharon E. Hesterlee - MDA

John D. Porter - NINDS, NIH, Executive Secretary, MDCC

Other Meeting Participants:

Donald Fink - CBER, FDA

Laurie Gutmann - NINDS, NIH

P. Rodney Howell - NICHD, NIH

Robert Jaeger - NIDRR, Department of Education

Nick Manetto - B&D Consulting / Parent Project MD

Judith Massicot-Fisher - NHLBI, NIH

Glenn Nuckolls - NIAMS, NIH

Vivian Owusu - NIDRR, Department of Education

Audrey Penn - NINDS, NIH

Wilma Peterman - NIAMS, NIH

Heather Rieff - NINDS, NIH

Lynn Rundhaugen, NINDS, NIH

Margaret Schaefer - Administration on Developmental Disabilities, ACF

Paul Scott - NINDS, NIH

Giovanna Spinella - ORD, NIH

Madeline Turkeltaub - NIAMS, NIH

Julie Wilberding - Department of Defense

Last Modified December 27, 2013