Category Archives: Ds Government News

Federal Budget Updates Related to Down Syndrome Research

Our Dr. Harpold stays closely connected to and works in the world of research, not only Down syndrome and Alzheimer’s disease, but also relevant research endeavors at a broad scale. Here’s his take on the Federal 2016 Omnibus Budget Bill.

By Dr. Michael Harpold, LuMind RDS Chief Scientific Officer

The just enacted Federal 2016 Omnibus Budget Bill, which includes a $2 billion increase for NIH, represents significantly good news for advancing biomedical research including Down syndrome research.

Over approximately the past decade, the budget for NIH has remained essentially flat, translating to a more than 25% decline in actual NIH “research-buying” power. This has made securing funding for NIH research grants by researchers extremely difficult and, closer to home, created significant challenges in gaining increased NIH funding dedicated to Down syndrome research.

This newly enacted increase in NIH funding will enable funding for more NIH grants as well as significantly increased funding to address Alzheimer’s disease… all potentially good news for Down syndrome research.

In addition to work focused on NIH funding for Down syndrome throughout this year, LuMind RDS contributed to a recent final push for this increased funding, especially Alzheimer’s disease research, through our continuing membership and work together with Leaders Engaged in Alzheimer’s Disease leveraging together 80 member organizations, as a signatory on advocacy letters, which also specifically included Down syndrome reference, to the respective US House and Senate Appropriations committees’ leadership.

Among other important relevant appropriations in this new Federal budget:

  • National Institutes on Aging (NIA) Alzheimer’s disease and related dementias research funding will increase to $936 million, a $350 million, or almost 60%, increase above Fiscal Year 2015
  • NIA’s overall funding will increase by $400 million, more than 85% of that for dementia
  • The Center for Disease Control (CDC) will have 3.5 million for its Alzheimer’s Disease (brain health) program, and
  • Food and Drug Administration (FDA) funding will increase 5%, roughly $90-100 million more than House and Senate appropriators passed earlier this year.

Thank you for the momentum you’ve helped to create to bring the importance of increasing funding for all types of research to the attention of the government.

Please consider continuing to show your support for Down syndrome research with a donation during our Annual Appeal.

21st Century Cures Act Passes in US House – What It Means for Down Syndrome Research

By Dr. Michael Harpold, LuMind RDS Chief Scientific Officer

US_Capitol_SouthThe 21st Century Cures Act, originating and developed out of the US House Energy and Commerce Committee, has been working its way through to a vote in the US House of Representatives. LuMind RDS signed the letter of support organized by National Health Council, in conjunction with our membership with the LEAD Coalition (Leaders Engaged on Alzheimer’s Disease), which had more than 250 organizations as signatories.

Prior to the vote on the overall Bill in the House of Representatives, there was a problematic “Brat et al. amendment” that had been introduced which would have jeopardized the increased funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) provided in the Bill as well as the wide bipartisan support. Through the National Health Council/United for Medical Research, LuMind RDS, along with more than 270 other organizations, signed on in opposition to the “Brat amendment” (

I am quite pleased to update that Friday July 10, 2015, the 21st Century Cures Act passed the US House by 344-77, and the “Brat et al amendment” was defeated by vote of 141-281. Among other aspects that are important for Down syndrome, the Bill increases NIH’s budget by additional $8.75 billion over five years. 

This is good news because the flat (in actuality, significantly declining in real dollars) NIH budget over the past five years or so has had a major impact in reducing the number and size of NIH research grants. The increased funding should increase overall NIH grant applications’ funding success and increased numbers of NIH grants, including hopefully more grants for Down syndrome research.

But before that increase is realized, the Bill needs to now make its way through and pass the Senate… which will be an additional effort for continuing support from the Down syndrome community.

Dr. Harpold Quoted in Education Week Articles on Down Syndrome Research

Education Week HeaderEducation WeekLuMind Foundation’s Chief Scientific Officer, Dr. Michael Harpold, was quoted in an article by Education Week on the NIH Down Syndrome Research report.

In the article, titled “NIH Resets Study Plans for Down Syndrome,” author Sarah Sparks summarizes the seven-year research plan, including discussing a greater focus on students in educational settings.

Dr. Harpold is quoted on the report illustrating an emphasis on improving cognition and the interrelationships between educational approaches and research areas. He also acknowledges that funding for research endeavors is a critical factor in progressing research.

Read more comments by Dr. Harpold on NIH’s research plan and read the entire Education Week article here.

Dr. Harpold was also quoted in another article, also on Education Week, discussing DS-Connect, the Down syndrome registry. Read that article here.





The ABLE Act passes!

We are so happy to join in the celebration of the passing of the ABLE Act. After passing house and the senate, President Obama signed the ABLE Act into law on Friday.

Thank you to all the people who worked tirelessly to pass the Achieving a Better Life Experience (ABLE) Act, including the politicians who sponsored and voted to pass the bill, members of our community who signed petitions and wrote letters to congress, and all the staff and stakeholders in all the communities for people who advocated for the bill.

A special recognition to Steve Beck, Jr., vice chair of the board of the NDSS, who passed away just before the bill was passed. Steve worked so hard to make the Act a reality.

A big shout-out to Sara Wolff who became one of the faces of the Act representing the Down syndrome community. Here’s Sara giving a speech back in May on the importance of the Able Act.


Dr. Harpold Announced as Chair, DS-Connect® Governance Board

A longtime participant in the DS Consortium and DS-Connect® Registry Governance Board, LuMind Foundation’s Dr. Harpold will lead the Board overseeing DS-Connect® as the registry moves into its second year.

Dr. Michael Harpold, chief scientific officer at LuMind Foundation, has accepted an invitation from the National Institutes of Health (NIH) to serve as Chair of the Registry Governance Board for DS-Connect®.

DS-Connect Homepage FullDr. Harpold has been serving as an active representative on the Down Syndrome Consortium, the private-public partnership that worked with the NIH to create DS-Connect®, the Down syndrome registry launched by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) last year. DS-Connect® is a health data registry for people living with a diagnosis of Down syndrome (DS). Dr. Harpold has also been serving as an inaugural member of the DS-Connect® Governance Board.

“Dr. Harpold’s commitment to research in Down syndrome and his contributions to the registry have had a major impact on its success. We are very pleased to have him serve as chair of the DS-Connect Governance Board,” said Dr. Melissa Parisi of NICHD, who serves as director of the registry and Chair of the Down Syndrome Consortium.

Dr. Harpold succeeds Dr. Yvonne Maddox, who served as Deputy Director of the NICHD until her recent appointment to serve as Acting Director of the National Institute on Minority Health and Health Disparities by the NIH Director.

“I am very honored to be asked to serve as the new chair of the DS-Connect® Governance Board and to continue working together with my distinguished fellow Governance Board colleagues, those on the DS-Connect® Operations Board and NICHD as DS-Connect® expands offerings, including launching a Professional Portal for approved researchers, clinicians and health practitioners to access aggregate de-identified data as well as design, develop and undertake important new research and clinical studies,” said Dr.Harpold. “I especially thank Dr. Yvonne Maddox for all of her tireless efforts in making DS-Connect® a reality, and her dedicated leadership as the inaugural chair of the DS-Connect® Governance Board. DS-Connect® represents a long-needed and incredibly important resource for researchers, clinicians and all of the Down syndrome community.”

“Dr. Harpold is a recognized leader in the Down syndrome research community,” said LuMind Foundation Executive Director Carolyn Cronin. “His experience, expertise and willingness to collaborate and connect with researchers, individuals with Down syndrome and families with a loved one with Down syndrome are all valuable assets to our organization and the greater Down syndrome community.”

DS-Connect® is designed to connect its registered participants with information about the larger Ds community, including providing people with Ds and their family members with important knowledge about medical and demographic information, new research findings and treatments and opportunities for participating in new research studies and clinical trials. All the data is kept secure and confidential and registrants have direct control over their information and if or how often they are notified of research opportunities. DS-Connect® currently has more than 2200 people registered.

Alzheimer’s Disease and Down Syndrome Funding Discussion on Senate Floor

Senator Jerry Moran questions NIH about funding for Down syndrome research during Senate Appropriations Hearing on Alzheimer’s disease research.

NIH establishes Down syndrome patient registry

Directly from NIH – A registry connects individuals with Down syndrome with researchers. Read more on the NIH website.
October 26, 2012

NICHD Invites Comments on the Ds Research Plan

The National Institute of Child Health and Human Development (NICHD) Issues Request for Information (RFI): Invitation to Comment on the Down Syndrome Research Plan Released in 2007

Down Syndrome Consortium Formed

NIH, Down syndrome groups to meet regularly for exchange of information, ideas to form a Down syndrome consortium. Read more.


Trisomy 21 Translational Research Parity Act Introduced in Congress

Importance for Down Syndrome Biomedical Research and New Opportunities

On September 25, 2009, the Trisomy 21 Translational Research Parity Act of 2009, or the “21 Act” (H.R. 3656) was introduced in the US House of Representatives by Representatives Cathy McMorris Rodgers (R-WA), Patrick Kennedy (D-RI), and Pete Sessions (R-TX).  A companion bill (S. 1762) was introduced on October 7, 2009 in the US Senate by Senators Sam Brownback (R-KS) and Sherrod Brown (D-OH). The “21 Act” represents an important critical step in expanding and coordinating Federal support for Down syndrome biomedical research, including translational research to convert the results of basic biomedical research through clinical trials into new therapies, and specifically includes:

  • Development and initial funding for a National Down Syndrome Patient Registry and Biobank;
  • Establishment of at least six Down Syndrome Translational Research Centers of Excellence; and,
  • Establishment of a Down Syndrome Coordinating Committee to coordinate activities across the National Institutes of Health, Centers for Disease Control  and with other Federal health programs and activities relating to Down syndrome.

The text of the “21 Act” can be found through this link.  A summary is attached below.

The Down Syndrome Research and Treatment Foundation (DSRTF) has worked closely with the sponsors of the legislation, as well as Down syndrome organizations and biomedical researchers and physicians to ensure this  legislation addresses critical needs for advancing new and recent biomedical research progress and potential new therapies for all individuals with Down syndrome.

How you can help:
We need to educate Members of Congress on the importance of enacting the Trisomy 21 Translational Research Parity Act of 2009.  There is much that yet needs to be accomplished to promote passage of this new “21 Act”.  Additionally, while the recently introduced “21 Act” includes initial funding appropriations for the National Down Syndrome Registry and Biobank, specific funding appropriations for the Down Syndrome Translational Research Centers of Excellence will require additional Congressional action. As you know, NIH funding for Down syndrome biomedical research has been, and continues to be, disproportionately and extremely low. We must continue to work together to increase Federal funding.

You can support this effort by contacting your Senators and Representative to ask that they join as co-sponsors of this legislation.  You can easily find contact information for your Senators and Representative and use the supporting draft email/letter through this link.

If your House Representative is not already a member of the Congressional Down Syndrome Caucus, this may also provide a great opportunity for you to include an additional note or separate email asking that they join the Congressional Down Syndrome Caucus. To see whether or not your Representative may already be a member of the Caucus, you can review the current list of members through this link.

Since being founded in 2004, DSRTF has become the largest non-governmental source of funding Down syndrome biomedical research focused on cognition and generated more than $5.6 million to fund critically needed major new results-driven research, with exciting advances, to improve cognition for individuals with Down syndrome.  As DSRTF continues to grow and advance its efforts with your much appreciated support, it is also critical that increased Federal funding for Down syndrome biomedical research becomes a reality to sustain and extend new advances to create deserved new opportunities for all individuals with Down syndrome.  Thank you for your efforts and help.

Trisomy 21 Translational Research Parity Act of 2009 (S. 1762/H. 3656) – Summary

Down syndrome, or Trisomy 21, as it is called within the medical community, is caused by an extra copy of the 21st chromosome.  There are more than 400,000 people living with Down syndrome in the US.  An error in cell division, called non-disjunction, happens during development of reproductive cells prior to conception for reasons which we still do not understand.  The extra chromosome causes varying degrees of cognitive impairment and physical abnormalities.

Persons with Down syndrome can also have a wide range of health problems, including congenital heart defects, obstructed digestive systems, thyroid conditions, hearing problems, leukemia, increased susceptibility to infection, sleep apnea, and respiratory problems.  Individuals with Down syndrome also are at a higher risk of developing Alzheimer’s disease, epilepsy, autism, and many neurological and psychiatric disorders, including obsessive-compulsive disorder and depression.

The Trisomy 21 Translational Research Parity Act of 2009 (the 21 Act) would establish an infrastructure within the Department of Health and Human Services (HHS) to facilitate results-oriented research, forge new partnerships between academic institutions and clinics to work together to conduct translational research, produce targeted-funding opportunities, and help to develop new interventions, treatments, and therapeutics for Down syndrome.

Translational Research:  The creation of Down Syndrome Centers of Excellence at the NIH would integrate basic and translational research and move findings efficiently toward clinical applications in Down syndrome.  Research conducted on Down syndrome may also have spinoffs that increase knowledge about other areas of research, diseases, and conditions.  Through outreach and communication efforts, the Centers will inform researchers and the public of scientific advances and improvements in medical care.

As you may know, the Children’s Health Act of 2000 (Public Law 106-310) amended the Public Health Service Act and included a number of provisions that addressed the research and surveillance needs of many disabilities (e.g., autism, traumatic brain injury, Fragile X, juvenile diabetes, asthma, epilepsy).  However, this landmark legislation did not address the significant research, surveillance, and clinical care needs of Down syndrome and thus has been an impediment to progress in the Down syndrome research community over the last decade. The 21 Actattempts to incorporate Down syndrome as an area of permissible research and surveillance at the National Institutes of Health and the Centers for Disease Control and Prevention and will foster a better understanding of Down syndrome.

Coordination:  The 21 Act would expand, intensify, and coordinate translational research on Down syndrome across government, academic institutions, Down syndrome clinics, and industry.  Research and funding would be supported by administrative and program staff at the Department of Health and Human Services (HHS) and the individual NIH Institutes and Centers.  The bill also calls for the establishment of a Down Syndrome Coordinating Committee, which includes Federal agencies and members of the public appointed by the HHS Secretary, to coordinate activities across Federal health programs and activities relating to Down syndrome.

Surveillance:  The 21 Act would provide resources to build a National Down Syndrome Epidemiology program by constructing a National Down Syndrome Patient Registry and Biobank, through cooperative agreements at the CDC.  The National Down Syndrome Patient Registry and Biobank would:

  • Establish a centralized or distributed brain, cell, tissue, DNA, and RNA bank;
  • Characterize a cohort of patients for genotype-phenotype investigations to inter-operate with the bank; and
  • Correlate the nature and severity of cognitive deficits and age of onset and severity of dementia.

This comprehensive surveillance program would enhance the clinical care for patients with Down syndrome, help coordinate research and clinical activities through the Down Syndrome Translational Research Centers of Excellence with the activities of the registry and biobank, and create a common data entry and management system for Down syndrome patient data collection and analysis.