After reading the following post in the Arizona Daily Star (11/6/2011 p E6), I contacted Dr. Marilyn Heins, a Tucson pediatrician, parent, grandparent and the founder of the website ParentKidsRight.com, and asked her if I could post her Parentip of the Week here. Her column today focuses first on brain development and her presentation makes this concept - which can be complicated for those without a scientific background - easier to understand and then on teaching good choices. For those with children who also already may be exhibiting impulsive behavior, the tools may help. She said yes! so here's her Parentip:
Why do parents of teens need to know about the prefrontal cortex of the brain?
The prefrontal cortex is the boss. It is the part of the brain that takes information from other parts of the brain so that we can make decisions. The executive function that we need to make decisions comprises planning, organization, working memory and control over the part of our brain that would lead us to do stupid or dangerous things if unchecked.
The frontal cortex is the thin covering of the brain. It is the part of the brain that evolved last and had to fold in on itself, creating many valleys in order to achieve the size it needed to do its job within the skull. The prefrontal cortex is just behind our forehead.
Brain development starts before birth. And we know that this magnificent organ, which makes us human, continues making connections as long as we live. Connections (synapses) are the the marvelous biological demonstration of the interaction between genes (nature) and the environment (nurture). It's not either nature or the environment that counts, it's both.
Brain development all through life consists of and depends on plasticity.
No, our brains are not made of plastic. Plasticity means that the brain has the ability to change neuron pathways based on new input from new experiences.
[To the theme of my blog, the above is an important point for those of us who must teach our children to let go of harmful behaviors such as binging and purging or not eating at all and to learn new behaviors. This point illustrates in part why therapies such as cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) make a difference by helping our loved ones gain tools to help prevent a relapse.]
We used to think that brain growth ceased when physical growth did. Wrong!
As a matter of fact brain growth continues well into the 20's, which accounts for some of the puzzling aspects of teenage behavior.
When, oh when, can parents expect their teenager to develop a mature brain that can make wise choices? Alas, long after the teen years have passed, somewhere in mid-20's or even later.
So, what's a parent to do?
Start early to prepare your child for making good choices in this complex world.
Impart healthy values.
Be a dream-thrower: talk together about what wonderful things your child might do one day - college and travel and creative or socially important work.
Take a stand against the consumeristic, oversexed media culture.
Expect the best from your child at school.
Encourage children and teens to take healthy risks in sports and challenge themseves to reach a personal best.
Give children and teens ways to practice being grownups by gradually assuming responsibility in the home.
Let your children help make family rules so they learn the correlation between responsibility and freedom.
Give your teen increasing tiny doses of freedom so he or she can make little decisions. Tell them they will be "graded" and allowed bigger decisions later if they pass the course."
Information is provided about eating disorders, particularly of adults, to parents and other loved ones written by a parent who is in recovery from an eating disorder.
Welcome
When I created this blog, I was "getting on" in my early sixties, hence the blog name. However, my adult daughter's eating disorder and co-occurring emotional dysregulation disorder and other co-morbidities - ongoing for about 33 years - became and was our focus as we attempted to help her get into recovery. By learning about, reflecting on, reading about, attending conferences and writing about eating and brain disorders, I created a place to blog what I've learned. I hope this blog will be of use to others, especially families of and adult sufferers themselves to help them get into recovery. I update posts from time and the update date will be present at the top of the post.
Sadly, my daughter passed away in early October 2021 mainly because her body became so malnourished that she was immunocompromised, contracted a severe infection that was not properly addressed during an earlier hospital stay the month before, and developed an overwhelming non-covid pneumonia following surgery to save her life. I believe she should have been able to receive palliative care but Arizona, our country, and even the professionals trained in the treatment of eating disorders, particularly anorexia, are not "there" yet. I address the issue of palliative care in a recent post below, initially written in November 2021. I am not a certified eating disorder specialist. I am an Expert by Experience and college-educated with a BA in Community Work with an additional certificate in a one-year program in Business Administration from the same institution.
I am passionate about all of this because, as Shakespeare wrote in The Taming of the Shrew, Act 4, Scene 3: "My tongue will tell the anger [and sadness] of my heart or else my heart, concealing it, will break. And, rather than it shall, I will be free even to the uttermost, as I please in words."[2016]
Travel Guide
If you're new to my blog, I recommend you begin on the right side and take a look at the "Of Note" offerings. Read Dr. Cynthia Bulik's recent published interview (5/4/22) "Rethinking Eating Disorders" if you want to print an easy-to-understand professional's expert opinion about anorexia for your family doctor or the therapist. [Early intervention is absolutely critical. For those whose eating disorder is categorized as entrenched or severe and enduring, read the editorial comment by Stephen Touyz and Philipa Hay for a new approach about treatment. It is possible for your loved one to recover! I have also attached a link here for additional papers on the subject of severe and entrenched eating disorders. If you are a family member or friend of an adult with an eating disorder and have been at this for awhile, I refer you to the posts within the title "Adult Eating Disorders and Recovery Tools" found in the Index on the right hand side of this site. As well, in the "Of Note" section take a look at those posts with an asterisk. If you're a parent and need support, look for posts in the Index about parent support or parent toolbox.
In my opinion, the best book to buy, to refer to constantly and to share with members of the medical/psychiatric profession is "Sick Enough: A Guide to the Medical Complications of Eating Disorders" by Jennifer L. Gaudiani MD, CEDS, FAED. "Dr. Gaudiani aims to improve medical diagnosis and treatment, motivate recovery, and validate the lived experiences of individuals of all body shapes and sizes, while firmly rejecting dieting culture."
I recommend two groups who will support you on your journey - F.E.A.S.T and the National Alliance for Eating Disorders. Both maintain websites and Facebook private groups.
Sunday, November 6, 2011
When Kids CANT Eat
After breakfast this morning, I had intended to start a blog post on the F.E.A.S.T. Eating Disorder Conference in Old Town Alexandria, Virginia held on November 3 and 4, 2011. I have just returned from the conference at which, because of the need for a model of activism, Dr. Ruth Sullivan , the first president of the Autism Society of America spoke. But, I was sidetracked....
I opened our Sunday newspaper - The Arizona Daily Star - here to Section B, for Tucson and Region, and at the top of a page the headline, "When kids can't eat, local nonprofit offers vital help" jumped off the page at me.
At first I thought the article might refer to those kids whose families do not have enough funds to feed them. But no, the article literally is about children - people - who "cannot eat without help."
So I read further........ "....up to 75 percent of children on the autism spectrum have food aversions."
Where's the footnote!?! Is this true? Is there perhaps a link to eating disorders here? I know it's been explored before by others. Some people have wondered about such a link. I know I have. The autism spectrum indeed runs in one side of our family. And so do eating disorders but in a different side. Coincidence or more? Note to self: need to check with the Autism Society on the statistic presented.
I also learned from the article that there's a "....new local nonprofit group [that] wants to help families with early intervention." The group is called Nourish. It has a website. There's also a link on the site to therapy for those with autism.
So, interesting. I am happy to see that such a group now exists on behalf of those families who cannot afford the help because they earn too much to be eligible for AHCCCS and not enough to buy insurance coverage.
And, it would be interesting to learn the techniques used by Nourish to help children eat a balanced, nutritious meal. These tools might help those parents who want to help their children with anorexia, for example, eat.
I opened our Sunday newspaper - The Arizona Daily Star - here to Section B, for Tucson and Region, and at the top of a page the headline, "When kids can't eat, local nonprofit offers vital help" jumped off the page at me.
At first I thought the article might refer to those kids whose families do not have enough funds to feed them. But no, the article literally is about children - people - who "cannot eat without help."
So I read further........ "....up to 75 percent of children on the autism spectrum have food aversions."
Where's the footnote!?! Is this true? Is there perhaps a link to eating disorders here? I know it's been explored before by others. Some people have wondered about such a link. I know I have. The autism spectrum indeed runs in one side of our family. And so do eating disorders but in a different side. Coincidence or more? Note to self: need to check with the Autism Society on the statistic presented.
I also learned from the article that there's a "....new local nonprofit group [that] wants to help families with early intervention." The group is called Nourish. It has a website. There's also a link on the site to therapy for those with autism.
So, interesting. I am happy to see that such a group now exists on behalf of those families who cannot afford the help because they earn too much to be eligible for AHCCCS and not enough to buy insurance coverage.
And, it would be interesting to learn the techniques used by Nourish to help children eat a balanced, nutritious meal. These tools might help those parents who want to help their children with anorexia, for example, eat.
Tuesday, October 18, 2011
Who Gets Treatment, Who Does Not; Why Not - the Role of Data and Standards
I attended the NEDA conference a year ago. One of the statements I walked away with was
"The current advocacy efforts in the United States occur in an almost complete vacuum of data about the health services utilization of individuals who experience an eating disorder."
-- a quote provided by Dr. Russell Marx during his presentation and attributed to a document by Streigel-Moore.
I am bringing this up because there does need to be not only more data about the health services utilization of individuals who experience an eating disorder, there also needs to be some sort of standardization of this and other ED data so researchers, insurance companies, doctors, therapists, nutritionists and psychiatrists can look at studies and know that the information presented there is in the same "language" as in other studies.
I also believe that the Eating Disorder Community of parents, therapists, psychiatrists, organizations/associations, and those with ED's need to advocate for data collection about the prevalence of ED's, the outcomes of various forms of treatment for ED's, and lists of those therapists, medical doctors, and psychiatrists who are CURRENT re treatment of ED's.
A simple example would be the hidden difference (unless numbers of participants are revealed within the press release) between information noting there was a 50 percent success rate in a study when there were 20 people involved (meaning 10 successes, 10 not so) and when there is a study with similar results with, say, 4000 people.
Just this past week there was a series of articles in the New York Times about parity, insurance coverage for eating disorders, and comments about the need for residential treatment of eating disorders (among other topics). A longer commentary with links to the series of articles in the New York Times was provided by Dr. Julie O'Toole on this series.
Over the more than twenty years that my loved one has fought anorexia with bulimia subtype (I guess that's the best way to categorize the ED she has), the key factor -- an incredibly important factor -- has been getting her back from the brink of starvation and away from the symptoms that go along with starvation so that she could benefit from the use of therapy (cognitive behavioral, psychoanalytical, and dialectical behavioral therapy).
Here's a description of the symptoms of starvation (excerpt from Wikipedia, italics mine):
"Individuals experiencing starvation lose substantial fat and muscle mass as the body breaks down these tissues for energy. Catabolysis is the process of a body breaking down its own muscles and other tissues in order to keep vital systems such as the Nervous system and heart muscle functioning. Vitamin deficiency is a common result of starvation, often leading to anemia, beriberi, pellagra, and Scurvy. These diseases collectively can also cause diarrhea, skin rashes, edema,and heart failure. Individuals are often irritable and lethargic as a result.
Early symptoms include impulsivity, irritability, hyperactivity and possibly submissiveness. Atrophy(wasting away) of the stomach weakens the perception of hunger, since the perception is controlled by the percentage of the stomach that is empty. Victims of starvation are often too weak to sense thirst, and therefore become dehydrated.
All movements become painful due to muscle atrophy and dry, cracked skin that is caused by severe dehydration. With a weakened body, diseases are commonplace. Fungi, for example, often grow under the esophagus, making swallowing unbearably painful.
The energy deficiency inherent in starvation causes fatigue and renders the victim more apathetic over time. As the starving person becomes too weak to move or even eat, their interaction with the surrounding world diminishes."
Is there any wonder that the perceived (by others who make decisions about treatment) will to live has diminished?
I am an avid supporter of those who emphasize that re-nourishment is the first step back to health.
I know there are people (I was one of them) who can finally get sick and tired of being sick and tired and decide to change their behavior. I also know that at least two of my own blood relatives with eating disorders have not been able to do that (yet). In fact, one is slowly making progress,too! So my experience absolutely should not color whether or not my relatives obtain additional treatment. Yet, people will point to my experience and that of others who succeed and wonder. What "trait" did I get that they did not? Research needs to focus on this. And, very importantly, at least in my case I needed years of ongoing off and on therapy to help me develop a mind-set leading to success even though the ED behaviors no longer overtook me.
Recovery isn't a snap one's fingers or wave the magic wand moment.
So, how is re-nourishment accomplished when a person fights this process of eating but who at the same time is willing to undergo treatment because they want to get well; i.e. they do not want to die? What about those who are so overtaken by the disease that they have lost that core sense of fighting for their precious life? In what kind of environment can this be accomplished if environmental factors outside of a residential treatment setting interfere with the person's ability to "stay with the program" long enough to get re-nourished and "reframed" so to speak? These are important questions on behalf of people for whom the first or even the third in-treatment setting doesn't work.
If a person with cancer wants to live and can obtain hundreds of thousands of dollars worth of treatment in the form of surgery, radiation, and on-going chemotherapy, why is this not also uniformly available to those with an eating disorder, for example anorexia, who have a policy with the same insurance company? to those eligible for Medicaid and Medicare when somewhere in the system there are precedents for care for ED?
Could reliable data, collected using uniform standards assist in obtaining this kind of information in order to justify ongoing treatment? in persuading insurance company policy makers and state and national legislators all the way to the US Supreme Court that such treatment is necessary? This has worked in some States but not in others. More needs to be done.
I am asking these question because there are people in two organizations that I'm aware of right now who are working diligently to develop and apply agreed upon standards to other diseases and who have caught the attention of the FDA.
One is The Critical Path Institute and the other is CDISC.
Here is a recent press release about their collaboration regarding the treatment of Alzheimer's, also a disease of the brain.
Tucson, Arizona, October 17, 2011– Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) today announced the release of version 1.0 of the Alzheimer’s disease (AD) Therapeutic Area Standard (SDTM AD/Mild Cognitive Impairment User Guide). This was developed for the clinical research community to facilitate analysis and learning from clinical studies for treatment or prevention of AD.
The User Guide outlines a standardized set of data elements so that pharmaceutical companies and other medical researchers can more easily, and consistently, collect data that can be reliably pooled and compared.
Lynn Hudson, PhD, C-Path’s Chief Scientific Officer and Executive Director of C-Path’s Coalition Against Major Diseases (CAMD) noted, “Ultimately, this will result in increased efficiencies so that the U.S. Food and Drug Administration (FDA) and other regulatory agencies can more quickly and accurately review new applications for AD therapies, making it possible for medicines to reach patients more quickly and with greater assurances of safety and effectiveness.”
This is an early and landmark outcome from a joint C-Path/CDISC project to formalize and publish the CDISC AD standard based on the elements used in CAMD’s groundbreaking AD data repository. Collaborators in CAMD, which include global stakeholders from C-Path, CDISC, the AD clinical community, the pharmaceutical industry, government agencies, academia, and patient advocacy associations, reached consensus on the relevant pooled data domains, terminology, and definitions.
Early last year, seven of CAMD’s member organizations agreed to share their data from eleven recent AD clinical research studies and allowed it to be standardized, pooled, and made available to qualified researchers around the world. They invested significant in-kind resources to remap the retrospective data to the new format that is now the CDISC standard. Those organizations included Abbott Laboratories, Alzheimer’s Disease Cooperative Study, AstraZeneca Pharmaceuticals LP, GlaxoSmithKline, Johnson Johnson, Pfizer, and sanofi-aventis. C-Path worked with another collaborator, Ephibian, a Tucson, Arizona-based company that specializes in software development, databases, web solutions and information security, to build a secure online data repository.
Today, the database contains data from over 4,100 AD subjects mapped to the CDISC standard. Its level of detail and scope will enable researchers to more accurately project the course of mild cognitive impairment (MCI) as it progresses to AD, thereby enabling the design of more efficient clinical trials that have the maximum chance of demonstrating whether a new treatment is truly safe and effective.
CAMD members and scientists around the world use the database to develop mathematical models to better track the course of MCI and AD in patients generally, as well as in genetically-defined subsets.
Roughly 5.3 million people in the U.S. alone are afflicted with AD, with costs reaching as much as $175 billion annually Worldwide, it afflicts 30 million people, a number that is expected to quadruple by 2050. Halting or slowing the progression of this disease will prevent untold suffering and save tens of billions of dollars every year. “Pooling clinical data is a powerful way to gain new insights and leverage the efforts of companies that are developing new therapies,” said Raymond Woosley, MD, PhD, President and CEO of C-Path. “Scientists around the world can now use the combined, standardized data from clinical trials to better understand the true course of Alzheimer’s disease in patients.”
According to Rebecca Kush, PhD, President and CEO of CDISC, “Standards are essential to ensure that data can be aggregated for high quality research and robust analyses. Their value to companies and scientists increases substantially when they are used at the earliest stages of planning for a clinical trial, in the preparation of the protocol and the case report forms (including eCRFs). Adoption of core CDISC standards and the complementary new AD supplement, will enable far more rapid launch of clinical research studies of AD, and will also minimize or eliminate costly back-end data remapping (legacy data conversion). We are delighted to work with C-Path on this project and look forward to similar initiatives for additional therapeutic areas.”
Bron Kisler, Vice President of Strategic Initiatives of CDISC, pointed out that data standards will promote efficiencies in making progress against this disease. “If one trial cannot be reliably compared to another, we lose valuable information and often repeat costly mistakes. It would be like trying to accurately compare distances when they are variably represented and recorded in miles, kilometers, leagues, yards, and light years. If we are ever going to stave off Alzheimer’s disease, we need to be able to clearly study and learn from every piece of data.”
The mission of C-Path is:
To improve health and save lives by accelerating the development of safe, effective medicines.
The mission of CDISC is:
To develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
The Core Principles of CDISC are:
Lead the development of standards that improve efficiency while supporting the scientific nature of clinical research.
Recognize the ultimate goal of creating regulatory submissions that allow for flexibility in scientific content and are easily interpreted, understood, and navigated by regulatory reviewers.
Acknowledge that the data content, structure and quality of the standard data models are of paramount importance, independent of implementation strategy and platform.
Maintain a global, multidisciplinary, cross-functional composition for CDISC and its working groups.
Work with other professional groups to encourage that there is maximum sharing of information and minimum duplication of efforts.
Provide educational programs on CDISC standards, models, values and benefits.
Accomplish the CDISC goals and mission without promoting any individual vendor or organization.
This may all seem rather dry. I am highlighting this information about these two organizations because I believe similar collaborations as well as data standards will help organizations such as NEDA and NAMI and FEAST as well as researchers in the area of ED arrive at mutually understandable conclusions about what is needed to help those with eating disorders get on the path to recovery.
There are too many lives at stake here. My loved one's is one of them.
As a postscript - I learned while looking up Dialectical Behavioral Therapy today (November 6, 2011) for the guest post by Dr. Marilyn Heins on brain development/choices that a group is actively working to put together a list of therapists who provide this very important treatment. Their qualifications need to be part of the database, IMHO. I am raising this point because again here I believe that the Eating Disorder Community of parents, therapists, psychiatrists, organizations/associations, and those with ED's need to advocate for data collection about the prevalence of ED's, the outcomes of various forms of treatment for ED's, and lists of those therapists, medical doctors, and psychiatrists who are CURRENT re treatment of ED's.
"The current advocacy efforts in the United States occur in an almost complete vacuum of data about the health services utilization of individuals who experience an eating disorder."
-- a quote provided by Dr. Russell Marx during his presentation and attributed to a document by Streigel-Moore.
I am bringing this up because there does need to be not only more data about the health services utilization of individuals who experience an eating disorder, there also needs to be some sort of standardization of this and other ED data so researchers, insurance companies, doctors, therapists, nutritionists and psychiatrists can look at studies and know that the information presented there is in the same "language" as in other studies.
I also believe that the Eating Disorder Community of parents, therapists, psychiatrists, organizations/associations, and those with ED's need to advocate for data collection about the prevalence of ED's, the outcomes of various forms of treatment for ED's, and lists of those therapists, medical doctors, and psychiatrists who are CURRENT re treatment of ED's.
A simple example would be the hidden difference (unless numbers of participants are revealed within the press release) between information noting there was a 50 percent success rate in a study when there were 20 people involved (meaning 10 successes, 10 not so) and when there is a study with similar results with, say, 4000 people.
Just this past week there was a series of articles in the New York Times about parity, insurance coverage for eating disorders, and comments about the need for residential treatment of eating disorders (among other topics). A longer commentary with links to the series of articles in the New York Times was provided by Dr. Julie O'Toole on this series.
Over the more than twenty years that my loved one has fought anorexia with bulimia subtype (I guess that's the best way to categorize the ED she has), the key factor -- an incredibly important factor -- has been getting her back from the brink of starvation and away from the symptoms that go along with starvation so that she could benefit from the use of therapy (cognitive behavioral, psychoanalytical, and dialectical behavioral therapy).
Here's a description of the symptoms of starvation (excerpt from Wikipedia, italics mine):
"Individuals experiencing starvation lose substantial fat and muscle mass as the body breaks down these tissues for energy. Catabolysis is the process of a body breaking down its own muscles and other tissues in order to keep vital systems such as the Nervous system and heart muscle functioning. Vitamin deficiency is a common result of starvation, often leading to anemia, beriberi, pellagra, and Scurvy. These diseases collectively can also cause diarrhea, skin rashes, edema,and heart failure. Individuals are often irritable and lethargic as a result.
Early symptoms include impulsivity, irritability, hyperactivity and possibly submissiveness. Atrophy(wasting away) of the stomach weakens the perception of hunger, since the perception is controlled by the percentage of the stomach that is empty. Victims of starvation are often too weak to sense thirst, and therefore become dehydrated.
All movements become painful due to muscle atrophy and dry, cracked skin that is caused by severe dehydration. With a weakened body, diseases are commonplace. Fungi, for example, often grow under the esophagus, making swallowing unbearably painful.
The energy deficiency inherent in starvation causes fatigue and renders the victim more apathetic over time. As the starving person becomes too weak to move or even eat, their interaction with the surrounding world diminishes."
Is there any wonder that the perceived (by others who make decisions about treatment) will to live has diminished?
I am an avid supporter of those who emphasize that re-nourishment is the first step back to health.
I know there are people (I was one of them) who can finally get sick and tired of being sick and tired and decide to change their behavior. I also know that at least two of my own blood relatives with eating disorders have not been able to do that (yet). In fact, one is slowly making progress,too! So my experience absolutely should not color whether or not my relatives obtain additional treatment. Yet, people will point to my experience and that of others who succeed and wonder. What "trait" did I get that they did not? Research needs to focus on this. And, very importantly, at least in my case I needed years of ongoing off and on therapy to help me develop a mind-set leading to success even though the ED behaviors no longer overtook me.
Recovery isn't a snap one's fingers or wave the magic wand moment.
So, how is re-nourishment accomplished when a person fights this process of eating but who at the same time is willing to undergo treatment because they want to get well; i.e. they do not want to die? What about those who are so overtaken by the disease that they have lost that core sense of fighting for their precious life? In what kind of environment can this be accomplished if environmental factors outside of a residential treatment setting interfere with the person's ability to "stay with the program" long enough to get re-nourished and "reframed" so to speak? These are important questions on behalf of people for whom the first or even the third in-treatment setting doesn't work.
If a person with cancer wants to live and can obtain hundreds of thousands of dollars worth of treatment in the form of surgery, radiation, and on-going chemotherapy, why is this not also uniformly available to those with an eating disorder, for example anorexia, who have a policy with the same insurance company? to those eligible for Medicaid and Medicare when somewhere in the system there are precedents for care for ED?
Could reliable data, collected using uniform standards assist in obtaining this kind of information in order to justify ongoing treatment? in persuading insurance company policy makers and state and national legislators all the way to the US Supreme Court that such treatment is necessary? This has worked in some States but not in others. More needs to be done.
I am asking these question because there are people in two organizations that I'm aware of right now who are working diligently to develop and apply agreed upon standards to other diseases and who have caught the attention of the FDA.
One is The Critical Path Institute and the other is CDISC.
Here is a recent press release about their collaboration regarding the treatment of Alzheimer's, also a disease of the brain.
Tucson, Arizona, October 17, 2011– Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) today announced the release of version 1.0 of the Alzheimer’s disease (AD) Therapeutic Area Standard (SDTM AD/Mild Cognitive Impairment User Guide). This was developed for the clinical research community to facilitate analysis and learning from clinical studies for treatment or prevention of AD.
The User Guide outlines a standardized set of data elements so that pharmaceutical companies and other medical researchers can more easily, and consistently, collect data that can be reliably pooled and compared.
Lynn Hudson, PhD, C-Path’s Chief Scientific Officer and Executive Director of C-Path’s Coalition Against Major Diseases (CAMD) noted, “Ultimately, this will result in increased efficiencies so that the U.S. Food and Drug Administration (FDA) and other regulatory agencies can more quickly and accurately review new applications for AD therapies, making it possible for medicines to reach patients more quickly and with greater assurances of safety and effectiveness.”
This is an early and landmark outcome from a joint C-Path/CDISC project to formalize and publish the CDISC AD standard based on the elements used in CAMD’s groundbreaking AD data repository. Collaborators in CAMD, which include global stakeholders from C-Path, CDISC, the AD clinical community, the pharmaceutical industry, government agencies, academia, and patient advocacy associations, reached consensus on the relevant pooled data domains, terminology, and definitions.
Early last year, seven of CAMD’s member organizations agreed to share their data from eleven recent AD clinical research studies and allowed it to be standardized, pooled, and made available to qualified researchers around the world. They invested significant in-kind resources to remap the retrospective data to the new format that is now the CDISC standard. Those organizations included Abbott Laboratories, Alzheimer’s Disease Cooperative Study, AstraZeneca Pharmaceuticals LP, GlaxoSmithKline, Johnson Johnson, Pfizer, and sanofi-aventis. C-Path worked with another collaborator, Ephibian, a Tucson, Arizona-based company that specializes in software development, databases, web solutions and information security, to build a secure online data repository.
Today, the database contains data from over 4,100 AD subjects mapped to the CDISC standard. Its level of detail and scope will enable researchers to more accurately project the course of mild cognitive impairment (MCI) as it progresses to AD, thereby enabling the design of more efficient clinical trials that have the maximum chance of demonstrating whether a new treatment is truly safe and effective.
CAMD members and scientists around the world use the database to develop mathematical models to better track the course of MCI and AD in patients generally, as well as in genetically-defined subsets.
Roughly 5.3 million people in the U.S. alone are afflicted with AD, with costs reaching as much as $175 billion annually Worldwide, it afflicts 30 million people, a number that is expected to quadruple by 2050. Halting or slowing the progression of this disease will prevent untold suffering and save tens of billions of dollars every year. “Pooling clinical data is a powerful way to gain new insights and leverage the efforts of companies that are developing new therapies,” said Raymond Woosley, MD, PhD, President and CEO of C-Path. “Scientists around the world can now use the combined, standardized data from clinical trials to better understand the true course of Alzheimer’s disease in patients.”
According to Rebecca Kush, PhD, President and CEO of CDISC, “Standards are essential to ensure that data can be aggregated for high quality research and robust analyses. Their value to companies and scientists increases substantially when they are used at the earliest stages of planning for a clinical trial, in the preparation of the protocol and the case report forms (including eCRFs). Adoption of core CDISC standards and the complementary new AD supplement, will enable far more rapid launch of clinical research studies of AD, and will also minimize or eliminate costly back-end data remapping (legacy data conversion). We are delighted to work with C-Path on this project and look forward to similar initiatives for additional therapeutic areas.”
Bron Kisler, Vice President of Strategic Initiatives of CDISC, pointed out that data standards will promote efficiencies in making progress against this disease. “If one trial cannot be reliably compared to another, we lose valuable information and often repeat costly mistakes. It would be like trying to accurately compare distances when they are variably represented and recorded in miles, kilometers, leagues, yards, and light years. If we are ever going to stave off Alzheimer’s disease, we need to be able to clearly study and learn from every piece of data.”
The mission of C-Path is:
To improve health and save lives by accelerating the development of safe, effective medicines.
The mission of CDISC is:
To develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
The Core Principles of CDISC are:
Lead the development of standards that improve efficiency while supporting the scientific nature of clinical research.
Recognize the ultimate goal of creating regulatory submissions that allow for flexibility in scientific content and are easily interpreted, understood, and navigated by regulatory reviewers.
Acknowledge that the data content, structure and quality of the standard data models are of paramount importance, independent of implementation strategy and platform.
Maintain a global, multidisciplinary, cross-functional composition for CDISC and its working groups.
Work with other professional groups to encourage that there is maximum sharing of information and minimum duplication of efforts.
Provide educational programs on CDISC standards, models, values and benefits.
Accomplish the CDISC goals and mission without promoting any individual vendor or organization.
This may all seem rather dry. I am highlighting this information about these two organizations because I believe similar collaborations as well as data standards will help organizations such as NEDA and NAMI and FEAST as well as researchers in the area of ED arrive at mutually understandable conclusions about what is needed to help those with eating disorders get on the path to recovery.
There are too many lives at stake here. My loved one's is one of them.
As a postscript - I learned while looking up Dialectical Behavioral Therapy today (November 6, 2011) for the guest post by Dr. Marilyn Heins on brain development/choices that a group is actively working to put together a list of therapists who provide this very important treatment. Their qualifications need to be part of the database, IMHO. I am raising this point because again here I believe that the Eating Disorder Community of parents, therapists, psychiatrists, organizations/associations, and those with ED's need to advocate for data collection about the prevalence of ED's, the outcomes of various forms of treatment for ED's, and lists of those therapists, medical doctors, and psychiatrists who are CURRENT re treatment of ED's.
Monday, September 26, 2011
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