Post by wrblack on Nov 3, 2008 14:13:19 GMT -5
This may fall under the category of dispelling rumors no one has heard, but there's been some traffic, maybe some light and not a little bit of heat, on some lists and boards about this one.
For some time now a group of parents in Texas has been singing the praises of a new protocol to treat Down syndrome they developed.
I think we've touched on this business once or twice here.
Anyway, there's been enough interest and hubbub that Down Syndrome Education International saw fit to put together a statement, a statement endorsed by a number of individuals and organizations.
Here's a couple of links and snips:
blogs.downsed.org/downsed/2008/10/statement-on-th.html
31 October 2008
Statement on the use of Prozac, Focalin and Ginkgo as a "treatment" for Down syndrome
Clinicians, scientists and Down syndrome groups across the world have today issued a statement about the use of a protocol that is claimed to improve intelligence and behaviour for people with Down syndrome.
This protocol is being widely discussed online and promoted through a film being sold on DVD and screened in locations in the US. It is promoted by a group called the Changing Minds Foundation. It includes drugs approved for use in the treatment of depression and attention deficit and hyperactivity disorder. The claims for the protocol are based on studies of mice that carry additional copies of some of the genes thought to function similarly to those carried on human chromosome 21, and case studies presented in the promotional DVD.
The statement provides information about the protocol for families and healthcare professionals seeking to evaluate these claims. The statement concludes that there is no reliable evidence of benefit and no clear evidence of safety to support the use of this protocol.
Over 20 clinicians and scientists and 15 organisations have publicly endorsed the statement, offering a clear indication of the wide consensus cautioning families about the risks of the unproven therapy.
"We are pleased to have contributed to a wide collaborative effort to produce clear, robust and credible guidance about this potentially dangerous protocol," commented Frank Buckley, CEO of DownsEd International and DownsEd USA. Both organisations have endorsed the statement. He added, "Claims about unproven therapies now spread remarkably quickly. They can quickly create concerns for families around the world. The Down syndrome community has shown that it can respond very effectively, with regional, national and international organisations working together with healthcare professionals and scientists to prepare this statement."
The statement can be read in full online:
* The use of Ginkgo, Prozac and Focalin as a "treatment" for Down syndrome
* La utilización de Ginkgo, Prozac y Focalina como "tratamiento" para el síndrome de Down
* (Further translations are being prepared and will be linked from here and from the English version when available)
www.down-syndrome.org/statements/2106/
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.
doi:10.3104/statements.2106
Other versions
* Traducción al español
Introduction
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 made.
Because we care about your children, we strongly urge families to consider this information when considering the claims for this "treatment".
The protocol
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, ‘Body Bio Balanced Oil’ 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 children.
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 Down syndrome.
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 ‘treatment’ could be the result of many factors. Only a controlled trial can give clear evidence of treatment effects.
Scientific progress
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.
Further information
Ginkgo
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.
* www.nlm.nih.gov/medlineplus/druginfo/natural/patient-ginkgo.html
Fluoxetine (Prozac)
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.
* www.nlm.nih.gov/medlineplus/druginfo/meds/a689006.html
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.
* www.nlm.nih.gov/medlineplus/druginfo/meds/a603014.html
Folinic acid
Folinic acid supplementation has been shown to have no significant effects for infants and children with Down syndrome on a range of developmental measures.
* www.nlm.nih.gov/medlineplus/druginfo/natural/patient-folate.html
* www.bmj.com/cgi/content/full/336/7644/594
‘Off label’ 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, USA.
* Sindoor S Desai, BDS, Cleveland, New York, USA.
* Jesús Flórez, 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, USA.
* 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. Fundación Puertorriqueña Síndrome 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-Hôpital Nord, Service de Génétique, Saint Etienne, France
* 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.
* Deutsches Down-Syndrom InfoCenter, Hammerhöhe, Lauf, Germany.
* Down Syndrome Education International.
* Down Syndrome Education USA.
* Down Syndrome International.
* Down Syndrome New South Wales, Australia.
* Down Syndrome Research and Treatment Foundation, USA.
* European Down Syndrome Association.
* Fundación Iberoamericana Down21, Spain.
* Fundación Síndrome de Down de Cantabria, Spain.
* National Down Syndrome Congress, USA.
* National Down Syndrome Society, USA.
* Stichting Downsyndroom, The Netherlands.
* Trisomie 21 France.
Distribution of this statement
The use of Ginkgo, Prozac and Focalin as a "treatment" for Down syndrome is licensed under a Creative Commons Attribution-No Derivative Works 3.0 Unported License. In summary, this means that you are free to share, copy, distribute and transmit this statement as long as you do not alter it. For any reuse or distribution, you must make clear to others these terms.
For some time now a group of parents in Texas has been singing the praises of a new protocol to treat Down syndrome they developed.
I think we've touched on this business once or twice here.
Anyway, there's been enough interest and hubbub that Down Syndrome Education International saw fit to put together a statement, a statement endorsed by a number of individuals and organizations.
Here's a couple of links and snips:
blogs.downsed.org/downsed/2008/10/statement-on-th.html
31 October 2008
Statement on the use of Prozac, Focalin and Ginkgo as a "treatment" for Down syndrome
Clinicians, scientists and Down syndrome groups across the world have today issued a statement about the use of a protocol that is claimed to improve intelligence and behaviour for people with Down syndrome.
This protocol is being widely discussed online and promoted through a film being sold on DVD and screened in locations in the US. It is promoted by a group called the Changing Minds Foundation. It includes drugs approved for use in the treatment of depression and attention deficit and hyperactivity disorder. The claims for the protocol are based on studies of mice that carry additional copies of some of the genes thought to function similarly to those carried on human chromosome 21, and case studies presented in the promotional DVD.
The statement provides information about the protocol for families and healthcare professionals seeking to evaluate these claims. The statement concludes that there is no reliable evidence of benefit and no clear evidence of safety to support the use of this protocol.
Over 20 clinicians and scientists and 15 organisations have publicly endorsed the statement, offering a clear indication of the wide consensus cautioning families about the risks of the unproven therapy.
"We are pleased to have contributed to a wide collaborative effort to produce clear, robust and credible guidance about this potentially dangerous protocol," commented Frank Buckley, CEO of DownsEd International and DownsEd USA. Both organisations have endorsed the statement. He added, "Claims about unproven therapies now spread remarkably quickly. They can quickly create concerns for families around the world. The Down syndrome community has shown that it can respond very effectively, with regional, national and international organisations working together with healthcare professionals and scientists to prepare this statement."
The statement can be read in full online:
* The use of Ginkgo, Prozac and Focalin as a "treatment" for Down syndrome
* La utilización de Ginkgo, Prozac y Focalina como "tratamiento" para el síndrome de Down
* (Further translations are being prepared and will be linked from here and from the English version when available)
www.down-syndrome.org/statements/2106/
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.
doi:10.3104/statements.2106
Other versions
* Traducción al español
Introduction
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 made.
Because we care about your children, we strongly urge families to consider this information when considering the claims for this "treatment".
The protocol
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, ‘Body Bio Balanced Oil’ 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 children.
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 Down syndrome.
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 ‘treatment’ could be the result of many factors. Only a controlled trial can give clear evidence of treatment effects.
Scientific progress
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.
Further information
Ginkgo
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.
* www.nlm.nih.gov/medlineplus/druginfo/natural/patient-ginkgo.html
Fluoxetine (Prozac)
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.
* www.nlm.nih.gov/medlineplus/druginfo/meds/a689006.html
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.
* www.nlm.nih.gov/medlineplus/druginfo/meds/a603014.html
Folinic acid
Folinic acid supplementation has been shown to have no significant effects for infants and children with Down syndrome on a range of developmental measures.
* www.nlm.nih.gov/medlineplus/druginfo/natural/patient-folate.html
* www.bmj.com/cgi/content/full/336/7644/594
‘Off label’ 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, USA.
* Sindoor S Desai, BDS, Cleveland, New York, USA.
* Jesús Flórez, 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, USA.
* 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. Fundación Puertorriqueña Síndrome 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-Hôpital Nord, Service de Génétique, Saint Etienne, France
* 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.
* Deutsches Down-Syndrom InfoCenter, Hammerhöhe, Lauf, Germany.
* Down Syndrome Education International.
* Down Syndrome Education USA.
* Down Syndrome International.
* Down Syndrome New South Wales, Australia.
* Down Syndrome Research and Treatment Foundation, USA.
* European Down Syndrome Association.
* Fundación Iberoamericana Down21, Spain.
* Fundación Síndrome de Down de Cantabria, Spain.
* National Down Syndrome Congress, USA.
* National Down Syndrome Society, USA.
* Stichting Downsyndroom, The Netherlands.
* Trisomie 21 France.
Distribution of this statement
The use of Ginkgo, Prozac and Focalin as a "treatment" for Down syndrome is licensed under a Creative Commons Attribution-No Derivative Works 3.0 Unported License. In summary, this means that you are free to share, copy, distribute and transmit this statement as long as you do not alter it. For any reuse or distribution, you must make clear to others these terms.
& it wacked him out but good. 
