H. R. 2077
IN THE HOUSE OF REPRESENTATIVES
April 3, 2019
Mr. Smith of New Jersey (for himself and Ms. Bass) introduced the following bill; which was referred to the Committee on Foreign Affairs, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
To galvanize United States Government programs in support of brain health for global victims of autism, hydrocephalus and Alzheimer’s and other forms of dementia, and for other purposes.
This Act may be cited as the
Global Brain Health Act of 2019.
Congress finds the following:
The brain is the center of the human nervous system, exerting centralized control over all other organs of the body.
Abnormalities in sections of the brain—namely the corpus callosum (which facilitates communication between the two hemispheres of the brain), the amygdala (which affects emotion and social behavior), and the cerebellum (which is involved with motor activity, balance, and coordination)—usually occur during prenatal development.
Three main brain disorders are autism, hydrocephalus and Alzheimer’s and other forms of dementia. They impact people in both the developed and developing world, but weigh more heavily on sufferers in developing countries due to lack of effective health care, lack of access to health care, or cultural influences that inhibit treatment of sufferers of one of these conditions.
Autism is a complex neurological disorder that affects an individual in the areas of social interaction and communication. Because it is a spectrum disorder, it affects each individual differently and to varying degrees of severity. People with autism process and respond to information in unique ways. In some cases, coexisting medical issues and aggressive or self-injurious behavior may be present.
The occurrence of autism spectrum disorders (ASD) has increased during the past decade from an estimated one in 150 in 2000 to an estimated one in 68 in 2012, according to data released by the Centers for Disease Control and Prevention (CDC) in December 2016. CDC classified as suffering from ASD children whose behaviors were consistent with the DSM–IV–TR criteria for Autistic Disorder, Asperger Disorder, and Pervasive Developmental Disorder—Not Otherwise Specified (PDD–NOS).
The increased number of children diagnosed with autism is a growing and urgent concern for families, healthcare professionals, and educators, as the health and education systems struggle to respond to the needs of this population in a comprehensive manner.
The prevalence of autism in developing countries is also growing rapidly, and health and education systems in these countries are particularly ill-equipped to deal with these issues. According to the World Health Organization, tens of millions of individuals in Africa are affected by autism.
Children with autism who receive intensive and appropriate educational services before age 5 often make significant functional improvements. In the United States, significant efforts are being pursued to expand early diagnosis and the provision of these services. In a report on the identification, evaluation, and management of children with autism, the American Academy of Pediatrics recommended in November 2007 that all children should be screened for developmental delays and disabilities, presumably including autism, twice by the age of 2, even if they have no symptoms. Early screening and services for autism are sorely lacking in most of the developing world. An opportunity exists to use United States expertise to significantly aid children and families in developing countries, for relatively small costs.
Hydrocephalus, also known as
water on the brain, is a medical condition in which an abnormal accumulation of cerebrospinal fluid in the ventricles or cavities of the brain causes increased intracranial pressure inside the skull and progressive enlargement of the head. If left untreated, hydrocephalus leads to physical and mental disabilities and eventually death.
Hydrocephalus is an extremely painful condition that most commonly occurs in infants and young children as a result of a congenital abnormality (anatomic abnormality, aqueductal stenosis, spina bifida or encephalocele), or post-infectious hydrocephalus (PIH) caused by infections acquired after birth, such as meningitis, that attack the brain.
In developed countries, up to one of every 1,000 newborns develop hydrocephalus, while up to five of every 1,000 newborns in developing countries develop the condition. It is conservatively estimated that more than 300,000 children are born with or acquire hydrocephalus in the developing world each year. Experts posit that hydrocephalus is more common in developing countries because of higher birth rates, as well as high rates of nutritional deficiencies, low infant birth weight, and perinatal and neonatal infections.
Children with hydrocephalus who are not effectively treated or who are not treated in the early stages of the condition suffer from cognitive deficiencies or physical disabilities or both.
Families of children who have hydrocephalus in developing countries rarely know that it is a treatable condition, where to go for treatment, or how to care for a child suffering from the condition. In addition, access to care is limited in many developing countries due to low numbers of practicing neurosurgeons. In 2007, for example, Africa had 565 neurosurgeons, roughly 86 percent of whom were practicing in South Africa and Northern Africa.
Many children with hydrocephalus in developing countries are abandoned, ostracized, or abused due to their appearance, physical and mental disabilities, and inadequate options for care.
Hydrocephalus can be treated, and advances in innovative medical procedures such as ETV/CPC have the potential to save thousands of lives annually and prevent or mitigate physical and mental disabilities in thousands of children in developing countries.
A number of international studies show that between 3.5 to 15 percent of all patients diagnosed with Alzheimer’s or another form of dementia actually have Normal Pressure Hydrocephalus, a condition in which there is too much cerebrospinal fluid, used to cushion and protect the brain and spinal cord, in cavities in the brain called ventricles. Such significant incidents of misdiagnosis illustrate the need for greater awareness among members of the medical profession and the general public of adult hydrocephalus, as well as the need for adopting a holistic approach towards brain health instead of a siloed one.
Dementia is a degenerative condition caused by disease of the brain—usually of a chronic or progressive nature in which there is disturbance of multiple higher cortical functions, including memory, thinking, orientation, comprehension, calculation, learning capacity, language, and judgment. Between 5 to 7 percent of the world’s population age 60 and above are estimated to have dementia.
Dementia can be caused by various factors, including traumatic or localized brain injury, a temporary interruption of the brain’s supply of blood or oxygen, infection, stroke, brain hemorrhage, prolonged seizures, or even excessive alcohol use.
According to Alzheimer’s Disease International, more than 47,000,000 people worldwide were suffering from Alzheimer’s or dementia in 2015, a figure that will expand to more than 75,000,000 people by 2030 and more than 131,000,000 people by 2050 if the current trajectory of the disease remains unchanged. Globally, a new person develops dementia every four seconds. Almost 60 percent of people with dementia globally live in low-to-middle income countries, and by 2050 this percentage will exceed 70 percent.
Alzheimer’s disease and related dementias impose a devastating, unsustainable, and rapidly growing toll on the health and fiscal well-being of the United States and all countries. In 2015, dementia care cost an estimated $818,000,000,000, worldwide, more than 1 percent of the world’s Gross Domestic Product (GDP). The cost of dementia care is projected to reach $2,000,000,000,000 by 2030.
Global Autism Assistance
Global Autism Assistance Program
Establishment and purpose
The Administrator for the United States Agency for International Development shall establish and administer a health and education grant program, to be known as the Global Autism Assistance Program, to—
support activities under subsection (c)(2) by nongovernmental organizations and other service providers, including advocacy groups, focused on autism in developing countries; and
teach the teachers program under subsection (d) to train health and education professionals working with children with autism in developing countries.
Designation of eligible regions
Not later than 120 days after the date of the enactment of this Act, the Administrator, in consultation with knowledgeable autism organizations such as the World Autism Organization, the Autism Society of America, and Autism Speaks, shall designate not fewer than two regions in developing countries that are determined to—
require assistance in dealing with autism; and
have sufficient familiarity with issues related to autism to make effective use of the Global Autism Assistance Program.
Selection of implementing NGO
Not later than 180 days after the designation of eligible regions pursuant to subsection (b), the Administrator shall select and award a grant under this section to a nongovernmental organization with experience in autism-related issues to implement the Global Autism Assistance Program through selection and awarding of grants to local service providers and advocacy groups focused on autism.
A local service provider or advocacy group that receives a grant under paragraph (1) may use such grant to carry out any of the following activities (including, as appropriate, the translation into local languages of relevant English-language publications):
Education and outreach to the public
Use public service announcements and other public media to help the public become more aware of the signs of autism so that children with autism can be diagnosed and treated earlier.
Support to families
Development of resources for families, such as online web resource centers in local languages, dissemination of materials to parents of newly diagnosed children, such as information contained in the Centers for Disease Control and Prevention’s publication entitled
Learn the Signs, Act Early, or other suitable alternatives, and dissemination of educational aids and guides to help parents with their children’s development.
Support to educational institutions
Funding for schools or other educational institutions, focusing on teachers of the youngest students, and including the distribution of equipment or of the materials referred to in subparagraph (B).
Support to clinics and medical centers
Provision of funding to clinics and medical centers with proven records in addressing autism to assist with operating expenses, including personnel, equipment supplies, and facilities, development of assessment testing for autism, and acquisition of specialized equipment, such as augmentative communication devices.
Applications for grants
Submission of applications
To be eligible to receive a grant from the implementing nongovernmental organization, a local service provider or advocacy group shall submit to such implementing nongovernmental organization an application at such time, in such manner, and containing such information as such implementing nongovernmental organization may require.
Establishment of screening board
The implementing nongovernmental organization responsible for implementing the Global Autism Assistance Program shall establish a screening board to be known as the Project Advisory Board to review for content and appropriateness applications from local service providers or advocacy groups submitted in accordance with subparagraph (A).
The members of the Project Advisory Board shall be appointed by the implementing nongovernmental organization, in consultation with the Administrator, and in accordance with the following provisions:
Each member shall serve for a term of one year and each member may serve as many as three consecutive terms.
A member of the Project Advisory Board may continue to serve after the expiration of the term of such member until such time as a successor is appointed.
Membership of the Project Advisory Board shall include at least seven voting members who are members of autism advocacy groups, professionals working with autism, or otherwise associated with the autism community. Among the voting members of the Board shall be at least two parents from different families of individuals with autism, one medical professional working with autism, one teacher of individuals with autism, and one individual who has autism. Efforts shall be made to include on the Project Advisory Board individuals with experience working in the developing world.
Membership of the Project Advisory Board shall include non-voting members as determined appropriate by the Administrator.
Membership of the Project Advisory Board shall be chosen so as to ensure objectivity and balance and to reduce the potential for conflicts of interest.
Support and assistance
The implementing nongovernmental organization shall provide, contract for, and coordinate technical assistance in support of its mission in meeting the goals and purposes of this Act.
Teach the teachers
The implementing nongovernmental organization, acting on behalf of the Administrator, in consultation with the Project Advisory Board, shall establish a program, to be known as the Teach the Teachers Program, to—
identify health and education professionals to receive specialized training for teaching and working with youth with autism, including training conducted in two- or three-day workshops at locations within one of the regions designated pursuant to subsection (b); and
conduct training through two- or three-day biomedical conferences in at least two of the regions designated pursuant to subsection (b), including bringing medical and psychological specialists from the United States to train and educate parents and health professionals who deal with autism, including training related to—
biomedical interventions that can affect autism;
how nutrition and various metabolic issues can impact behavior;
the role of applied behavioral analysis; and
various occupational and speech therapies in fighting autism.
To carry out this section, the Administrator shall allocate amounts that have been appropriated or otherwise made available to the United States Agency for International Development.
The Administrator shall submit to the Committee on Foreign Affairs of the House of Representatives and the Committee on Foreign Relations of the Senate on an annual basis a report on activities carried out under this section during the prior calendar year.
In this section, the term autism means all conditions consistent with autism spectrum disorders described in section 2(5).
International hydrocephalus treatment and training
Assistance to treat hydrocephalus and train surgeons
Chapter 1 of part I of the Foreign Assistance Act of 1961 (22 U.S.C. 2151 et seq.) is amended by adding at the end the following:
Assistance to treat hydrocephalus and train surgeons
The purposes of assistance authorized by this section are—
to ensure that life-saving treatment of hydrocephalus is an important priority of United States bilateral foreign assistance, including through promotion of innovative treatments and training of medical practitioners from the developing world in the latest treatment protocols and best practices for the treatment of hydrocephalus, including—
surgery and post-surgery care in developing countries;
the creation of a comprehensive hydrocephalus training program based in the developing world for surgeons and key members of their medical team; and
the training of medical practitioners based in the developing world in ETV/CPC and other appropriate treatment protocols; and
to promote research to reduce the incidence of PIH epidemiology, pathophysiology, and disease burden, and to improve treatment of hydrocephalus.
To carry out the purposes of subsection (a), the President is authorized to provide assistance to support a network of trained medical practitioners to treat hydrocephalus in children at pediatric hospitals and hydrocephalus treatment centers in developing countries with a high incidence of hydrocephalus.
Assistance provided under subsection (b) shall, to the maximum extent practicable, be used to establish a comprehensive program to administer global hydrocephalus treatment and training activities utilizing a network of pediatric hospitals capable of performing endoscopic surgery in developing countries.
The program described in subparagraph (A) shall be administered by healthcare executives and neurosurgeons with expertise in the treatment of hydrocephalus.
The responsibilities of the administrators described in subparagraph (B) shall include—
developing an appropriate education and training curriculum;
establishing quality control standards;
instituting safety guidelines and standards; and
developing monitoring and evaluation protocols.
Assistance provided under subsection (b) shall, to the maximum extent practicable, be used to establish a surgeon training program within a pediatric hospital based in a developing country with a high incidence of hydrocephalus with the goal of training four surgeons annually and a total of 20 surgeons over a 5-year period to treat hydrocephalus utilizing the ETV/CPC technique.
To the maximum extent practicable, the surgeon training program described in subparagraph (A) should be operational no later than 1 year after the date of enactment of this section.
Training admissions criteria
Candidates for the surgeon training program established under subparagraph (A) shall—
have a demonstrated commitment to providing medical assistance in the developing world; and
certify that the candidate intends to remain and practice medicine in the developing world following completion of the program.
Training program methodology
The surgeon training program established under subparagraph (A) shall—
be conducted by a neurosurgeon with a minimum of 3 years of full-time operating experience in the developing world;
be a hands-on operating room experience in the developing world;
utilize a hydrocephalus treatment protocol with an emphasis on ETV/CPC as the preferred treatment when medically appropriate; and
require that each trainee complete a minimum of 50 ETV/CPC or ETV procedures and at least 25 VP shunt procedures.
Assistance provided under subsection (b) shall, to the maximum extent practicable, be used to establish at least 20 hydrocephalus treatment centers located at public and private hospitals in developing countries with a high incidence of hydrocephalus, which shall include treatment costs, endoscopy equipment and medical supplies necessary to provide ETV/CPC procedures to treat hydrocephalus.
The treatment centers described in subparagraph (A) shall be staffed by—
one or more surgeons who have successfully completed the surgeon training program provided pursuant to paragraph (2); and
a patient care administrator.
The treatment centers described in subparagraph (A) shall—
provide surgery to treat hydrocephalus in children;
perform at least 50 hydrocephalus surgeries annually including a minimum of 25 ETV or ETV/CPC surgeries; and
provide post-surgery care and support for the children treated in accordance with clause (i).
Medical records and data
Assistance provided under subsection (b) shall, to the maximum extent practicable, include the maintenance of medical records which track patient care activities and information about the causes and incidence rates of PIH.
In this section:
The term CPC means choroid plexus cauterization, a surgical procedure to reduce the production of cerebrospinal fluid in the brain.
The term ETV means endoscopic third ventriculostomy, a shunt-less surgical procedure in which an opening is created in the floor of the third ventricle of the brain allowing cerebrospinal fluid to bypass any obstruction and flow directly to the basal cisterns.
The term ETV/CPC means the shunt-less surgical method for treating hydrocephalus through the combination of ETV and CPC surgical procedures.
The term hydrocephalus means a medical condition in which an abnormal accumulation of cerebrospinal fluid in the ventricles or cavities of the brain causes increased intracranial pressure inside the skull and progressive enlargement of the head.
The term medical practitioners means physicians, nurses, and other clinicians, such as physical therapists.
The term PIH means post-infectious or acquired hydrocephalus which is the onset of hydrocephalus after birth due to the affects of an infection, such as meningitis, that has attacked the brain.
The term VP shunt means a ventriculoperitonea shunt which is a plastic tube that is regulated by a valve and surgically placed in a brain ventricle that allows the cerebrospinal fluid to flow out of the brain through the tube and into the patient’s abdomen.
Authorization of appropriations
Of the amounts made available to carry out this chapter for child survival and maternal health programs through the Bureau of Global Health of the United States Agency for International Development, there are authorized to be appropriated to the President $375,000,000 for each of the fiscal years 2021 through 2025 to carry out this section.
International Alzheimer’s Disease and Dementia Programs
Global Alzheimer’s Disease and Dementia Action Plan
The Secretary of Health and Human Services shall enter into negotiations with the World Health Organization to develop a plan for addressing Alzheimer’s disease and other forms of dementia globally, to be known as the Global Alzheimer’s Disease and Dementia Action Plan, focused on the following areas:
clinical research; and
development of a stable and sustained international commitment to research.
Supportive services for patients and caregivers, including supports using innovative technologies.
Prevention and health promotion.
Public awareness and education, particularly efforts aimed at reducing stigmas and increasing the inclusion of persons with Alzheimer’s disease and dementia within civil society.
In developing the plan under subsection (a), the Secretary of Health and Human Services—
to enter into partnerships with other nations that have in place national plans for addressing Alzheimer’s disease and other forms of dementia; and
to the greatest extent possible, ensure that the plan under subsection (a) is compatible with the plans of such other nations; and
in the case of other nations that do not have such plans in place, shall encourage such nations to develop and implement such plans.
Sense of Congress
It is the sense of the Congress that the Group of Eight (G8) nations, working with the Group of Twenty (G20) nations, the Group of Seventy-Seven (G77) nations, and other organizations including the Organization for Economic Cooperation and Development (OECD), should investigate systems to monitor and provide care to individuals with Alzheimer’s disease and other forms of dementia in developing countries to help build care delivery capacity.
Global Alzheimer’s Disease and Dementia Fund
The Secretary of Health and Human Services, working with the Secretary of the Treasury, other nations, nongovernmental organizations, and private entities, shall seek to establish a fund, to be known as the Global Alzheimer’s Disease and Dementia Fund, to provide resources to support implementation of the Global Alzheimer’s Disease and Dementia Action Plan.
In the early stages of carrying out subsection (a), the Secretary of Health and Human Services shall establish priority areas of focus and a governance structure for the Global Alzheimer’s Disease and Dementia Fund.
Alzheimer’s disease and dementia coordinator
The President shall appoint a high-level official from the Department of Health and Human Services to lead and coordinate all efforts of the Federal Government with respect to developing the Global Alzheimer’s Disease and Dementia Action Plan and the Global Alzheimer’s Disease and Dementia Fund.
Foreign aid implications
The Secretary of Health and Human Services, in collaboration with the heads of the United States Agency for International Development and other relevant Federal departments and agencies, shall—
investigate the foreign aid implications of Alzheimer’s disease and other forms of dementia; and
inform Congress as to the need for possible changes to health care-related foreign assistance.
The President shall encourage and facilitate partnerships between the Federal Government and the private sector, such as the partnerships in effect between the National Institutes of Health and pharmaceutical companies, to identify new approaches to treat Alzheimer’s disease and other forms of dementia.