The use of Ginkgo, Prozac and Focalin as a "treatment" for Down syndrome
A combination of drugs recommended for depression and attention deficit and hyperactivity disorder is being widely promoted as a "treatment" for Down syndrome. There is no scientific support for the routine use of this protocol by people who have Down syndrome. It is important that families and healthcare professionals are aware of the lack of evidence for safety and benefits from use of this protocol.
We are a group of healthcare professionals, scientists and support organizations
who care for and about people with Down syndrome. We wish to provide families with
information about a proposed "treatment" for Down syndrome. We recognize that all
parents wish to improve the lives of their children with Down syndrome and are interested
in treatments, therapies and interventions that can help. We respect these wishes.
At the same time, we are concerned that these "treatments" are potentially dangerous.
We are all aware of the advances that have been made in the basic science of memory
and cognition in animal models of Down syndrome and are hopeful that these studies
may lead to new ways to improve the lives of people who live with the condition.
Physicians and biomedical scientists evaluate potential interventions on the basis
of safety and benefits to patients. As we describe below, the "treatments" that
the Changing Minds Foundation recommends have not passed either test: there is no
information whether these compounds are safe for children, especially young children.
Furthermore, there is no evidence to support the claims for benefits that have been
Because we care about your children, we strongly urge families to consider this
information when considering the claims for this "treatment".
An organization called the Changing Minds Foundation is promoting a "new treatment
for Down syndrome" that leads to "life changing" results. The "treatment"
includes regular doses of Fluoxetine (Prozac), Dexmethylphenidate (Focalin XR) and
Ginkgo biloba, Phosphatidylcholine, â€˜Body Bio Balanced Oilâ€™ and folinic acid. Some
of these substances are associated with potential harmful side-effects. Some of
these side-effects are of particular concern for people with Down syndrome and younger
Fluoxetine (Prozac) is used to treat depression, obsessive-compulsive disorder,
bulimia nervosa and panic disorder. Dexmethylphenidate (Focalin XR) is used for
the treatment of attention deficit and hyperactivity disorder (ADHD). Their use
should be initiated and monitored by an appropriately qualified physician and should
be limited to applications and treatments formally reviewed and approved by appropriate
governmental and medical drug regulatory agencies.
Evidence of effects and safety
There is no scientific evidence to support the use of any of this protocol with
people with Down syndrome of any age in order to improve memory or any other aspect
of cognition. Nor is there any evidence that this protocol is safe for routine use
with people who have Down syndrome.
The few studies referenced in support of this protocol are studies of mice. These
mice have been engineered to carry extra copies of some genes similar to genes found
on human chromosome 21. (People who have Down syndrome have an additional copy of
this chromosome). These studies may or may not be good indicators of aspects of
memory and learning for people who have Down syndrome. Studies in mice alone are
not sufficient to support use of this (or any) protocol in children or adults with
The Changing Minds Foundation promotional videos do not prove the claims of benefit
from the protocol. While the people shown are clearly doing well, none of the individuals
shown are functioning beyond the wide range seen in others with the syndrome. Claimed
changes following â€˜treatmentâ€™ could be the result of many factors. Only a controlled
trial can give clear evidence of treatment effects.
Scientific research has improved our understanding of Down syndrome considerably
over the past 30 years. This has led to the better healthcare and education received
by many people with Down syndrome today. Many scientists and organizations continue
to work to improve our knowledge and understanding of effective ways to improve
quality of life for people who live with Down syndrome.
Although the pace of further progress is often slow and this can be frustrating,
only careful research and rigorous controlled trials can provide the evidence necessary
to demonstrate that a therapy is useful and safe.
Although bilobalide, a component of Ginkgo Biloba, has been shown to be a GABA antagonist,
the activity has been tested only in isolated cells and in only one subtype of GABA
receptors. No controlled studies have been done in animals or humans to establish
safe doses, or to prove the claimed benefits.
The action of fluoxetine on the growth of new nerve cells seen in one part of the
brain of Ts65Dn mice has not been replicated in humans. Published case reports suggest
that medications like Prozac used in pregnancy can harm the fetus. The potential
impact on developing minds of babies and young children is unknown. A general, or
uncontrolled, increase in nerve cell growth is not necessarily a good thing, especially
over long periods of time.
Dexmethylphenidate (Focalin XR)
The use of stimulant medication should be carefully considered for children with
unusual heart structures, which includes about half of children with Down syndrome.
Again, use is not recommended for babies or very young children.
Folinic acid supplementation has been shown to have no significant effects for infants
and children with Down syndrome on a range of developmental measures.
â€˜Off labelâ€™ use
Families and healthcare professionals should understand that use of the protocol
at this time is essentially experimental, with none of the benefits of a controlled
trial. Monitoring for adverse effects would be the responsibility of the prescribing
physician, with no one collecting that information to determine real risks. Similarly,
positive effects would not be collected in a credible way that could be used by
healthcare professionals to gauge the value of the treatments.
While there is no current evidence of the treatment's effectiveness for people
with Down syndrome, there are significant risks of harm.
This statement is endorsed by the following scientists and clinicians:
- Roel Borstlap, Paediatrican n.p., Stichting Downsyndroom, The Netherlands.
- Sue Buckley OBE. Director of Science and Research, Down Syndrome
Education International and Emeritus Professor of Developmental Disability, University
of Portsmouth, UK.
- William I Cohen, MD. Developmental-Behavioral Pediatrician, Director,
Down Syndrome Center of Western PA Children's Hospital of Pittsburgh of UPMC,
Professor of Pediatrics and Psychiatry, University of Pittsburgh School of Medicine,
- Sindoor S Desai, BDS, Cleveland, New York, USA.
- JesÃºs FlÃ³rez, MD, PhD. Professor of Pharmacology, University of
Cantabria School of Medicine, Santander, Spain.
- Sallie Freeman, Ph.D. Professor Emeritus. Down Syndrome Clinic
Advisor, Department of Human Genetics, Emory University School of Medicine, Georgia,
- Edward J Goldson, MD. Pediatrician, The Children's Hospital,
Aurora, Colorado, USA.
- Lilliam Gonzalez de Pijem, MD. Pediatric Endocrinologist. Puerto
Rico Down Syndrome Association, San Juan, Puerto Rico.
- Joan E Guthrie Medlen, RD, LD. Vice President Down Syndrome Education
USA, Director, Disability Compass, Publisher, Phronesis Publishing, Author, The
Down Syndrome Nutrition Handbook.
- Rob Hanson, MD, PhD. Pediatric Cancer and Hematology Center, St.
John's Mercy Medical Center, St. Louis, Missouri, USA.
- Michael M Harpold, PhD, Chief Executive Officer, Down Syndrome
Research and Treatment Foundation, USA.
- Jacqueline London, Professor of Molecular and Pathological Biochemistry,
University Paris-Diderot, Paris, France.
- Acisclo M Marxuach, MD. FundaciÃ³n PuertorriqueÃ±a SÃndrome Down,
San Juan, Puerto Rico.
- Philip J Mattheis, MD. Associate Professor, Cincinnati Children's
Hospital Medical Center, Ohio, USA.
- William C Mobley MD, PhD. Professor, Department of Neurology and
Neurological Sciences and Director, Center for Research and Treatment of Down Syndrome,
Stanford University, California, USA.
- David Patterson, PhD. Professor, Department of Biological Sciences,
Eleanor Roosevelt Insitute, University of Denver, Colorado, USA.
- Alberto Rasore-Quartino, Professor, Unit of Neonatology, Galliera
Hospital, Genoa, Italy.
- David S Smith, MD. Program Director, Down Syndrome Clinic of Wisconsin
Children's Hospital, Wisconsin, USA.
- Dr Renaud Touraine, CHU-HÃ´pital Nord, Service de GÃ©nÃ©tique, Saint
- Jeannie Visootsak, MD, FAAP. Assistant Professor, Developmental-Behavioral
Pediatrics, Department of Human Genetics & Pediatrics, Emory University School
of Medicine, Georgia, USA.
- Patricia White, MD, Chair, Board of Directors, Down Syndrome Research
and Treatment Foundation, USA.
This statement is endorsed by the following organizations:
Association Francaise pour la Recherche sur la Trisomie 21, France.
- Association of Parents and Friends
of Children with Down Syndrome, Prague, Czech Republic.
de Resurse Sindrom Down, Bucharest, Romania.
- Deutsches Down-Syndrom InfoCenter,
HammerhÃ¶he, Lauf, Germany.
- Down Syndrome Education International.
- Down Syndrome Education USA.
- Down Syndrome International.
- Down Syndrome New South Wales,
- Down Syndrome Research and Treatment Foundation,
- Down Syndrome Research
Foundation, Vancouver, Canada.
- European Down Syndrome Association.
- FundaciÃ³n Iberoamericana Down21,
- FundaciÃ³n SÃndrome de Down de Cantabria,
- National Down Syndrome Congress,
- National Down Syndrome
- Stichting Downsyndroom,
- Trisomie 21 France.
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The use of Ginkgo, Prozac and Focalin as a "treatment" for Down syndrome
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DSE's Reading and Language Intervention for Children with Down Syndrome (RLI) is an evidence-based programme designed to teach reading and language skills to children with Down syndrome.
RLI incorporates best practice in structured activities delivered in fast-paced daily teaching sessions. It was evaluated in a randomised controlled trial and found to improve rates of progress compared to ordinary teaching.
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