Tag: Informed Consent

Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials

Written by AbleChild on June 13, 2022. Posted in Essential Books.

The decision to participate in a clinical trial should not be made on a whim or taken lightly. Thankfully, this one-of-a-kind, comprehensive and beyond helpful guide is designed for the very purpose of providing necessary information to patients, their family and advocates before giving consent to volunteer for clinical trials. The guide, written by Ken Getz and Deborah Borfitz, is also designed to help keep participants informed throughout the clinical trial.

Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials is an excellent resource for helping patients understand their rights as a clinical trial participant, what the process is like. It also clearly defines what the role is of research professionals, and what participants can expect overall from a clinical trial. The guidebook has been reviewed and acknowledged by research and regulatory experts, patient advocates and consumers.

The book also guides patients on how to find a clinical trial that meets their needs and interests, and how to determine if a trial is right for them. There are specific guidelines in the book for more vulnerable groups of individuals, such as children and the elderly. The guidebook is also a great resource for advice about what clinical trial participants should do when things go wrong, and has a helpful appendix containing reference information.

About the Authors

Ken Getz

Ken Getz is the publisher, president and CEO of Centerwatch, a company that provides a variety of clinical research products and services, including: clinical trials and results, drug approvals, study grants, news and analysis, career and training opportunities for patients and professionals. He is a widely recognized expert on the clinical trial process, having spoken at conferences, published articles in scholarly and trade journals and books, and appeared on major national radio and television programs.

He has served as Director of Sponsored Research Programs and Associate Professor a Tufts CSSD, Tufts University School of Medicine. He is founder and board chair of the Center for information and Study on Clinical Research Participation (CISRP). Getz also sits on several other boards, including the Institute of Medicine’s Clinical Research Roundtable, and the Dors Duke Foundation’s Consortium to Examine Clinical Research Ethics. Getz received his bachelor’s degree from Brandeis University, and his MBA from the J.L. Kellogg Graduate School of Management at Northwestern University.

Deborah Borfitz

Deborah Borfitz has written for numerous health and business periodicals throughout her career, which spans over 30 years. She was a contributing writer for Centerwatch, and now serves as Senior Science Writer at Cambridge Healthtech Institute in Nashville, Tennessee. Other publications she has written for include Strategic Health Care Marketing, eHealthcare Strategy & Trends, and Medical Economics Magazine. Borfitz attended State University of New York College at Cortland and SUNY Oneonta.

Reviews

Carol Saunders, Executive Director, New England Institutional Review Board:

“…A comprehensive and balanced treatment, providing the research participant with the information and tools to make an informed decision.”

Paul Gelsinger, who wrote the foreword for Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials:

“This book informs the average human being about what to expect and ask when participating in clinical research.”

Dumbing Us Down: The Hidden Curriculum of Compulsory Schooling, 25th Anniversary Edition

Written by AbleChild on March 23, 2022. Posted in Essential Books.

With over 100 years of mandatory schooling behind us now, we have seen the progression of issues such as illiteracy and learning disabilities in our children. Dumbing Us Down: The Hidden Curriculum of Compulsory Schooling, which is John Taylor Gatto’s radical treatise on how the formal education system is damaging our children and families, is a true eye-opener. This New Society Publisher’s bestseller was originally published in 1992, had a 10th anniversary edition published in 2002, and the most recent 25th anniversary edition was printed in 2017, with a foreword from Zachary Stayback, who is an Ivy League dropout and cofounder of tech startup career foundry Praxis.

Gatto, who spent 30 years teaching in the public school system before writing this book, is an advocate for education being central to the family, instead of being used to separate children from their families. In the book, Gatto makes a strong case that effective education should promote individuality and privacy instead of conformity. Gatto is an advocate for home schooling, and points out how back in the 1800s children’s skill levels were developed much earlier than they are now, and far beyond what our school systems consider acceptable nowadays. The book also introduces the idea that genius is a very common quality that is being suppressed in our society, and we have been made to believe that genius is a rarity.

Dumbing Us Down, which opens with a speech given by Gatto in 1991 when he was named “Teacher of the Year,” is known to be a fairly easy read. In the book, Gatto explains how the modern public school system is driving out the natural curiosity and problem-solving skills children are born with, and replacing it with rule-following, fragmented time, and disillusionment. Gatto encourages children to be their own teachers and in charge of designing their own education. And he makes a strong case for why the mass education system that has developed in America does not support democracy or any of the values the United States was taught as a result of the American Revolution.

While Gatto explains how the school system itself is setting children up for failure, he also believes there are many humane and caring teachers in our schools that are just caught in a faulty system. Another key takeaway from this extremely valuable and timeless text is Gatto’s concept that “the teaching function, in a healthy community, belongs to everyone,” and that we should not just be looking to education professionals to define “good teaching.”

About the Author

John Taylor Gatto was born in on December 15, 1935, in Monongahela, Pennsylvania. He did his undergraduate work at the University of Pittsburgh, as well as Cornell and Columbia in New York. Gatto then served in the U.S. Army medical corps at Fort Knox, Kentucky and Fort Houston, Texas. After his military service, Gatto completed graduate work at the City University of New York, Hunter College, Yeshiva, the University of California, and Cornell.

Before and during Gatto’s teaching career, he served in various other occupations, many of which involved writing. He wrote scripts for the film business, wrote for advertising, was an ASCAP songwriter, and eventually founded Lava Mt. Records, which is an award-winning documentary record producer. Gatto’s record company has completed a variety of big-name projects, including presentations of speeches from Richard M. Nixon and Spiro Agnew.

Gatto’s teaching career garnered him quite a few awards. He was named New York City Teacher of the Year three times, and then held the title of New York State Teacher of the Year. After leaving his teaching career after 30 years, telling the Wall Street Journal that he was “no longer willing to hurt children,” he moved on to become a much-sought-after public speaker on the topic of school reform. His speaking engagements took him across all 50 states in the U.S., and to seven foreign countries.

Gatto had also recieved other awards, such as the Alexis de Tocqueville Award for his contributions to the cause of liberty. From 1996 on, he has been included in the Who’s Who in America. He has authored a handful of other books, including A Different Kind of Teacher and The Underground History of American Education.

Gatto passed away on October 25, 2018. His obituary on the website for the Foundation for Economic Education stated that after three decades in the classroom, “Gatto dedicated the rest of his life to repairing the damage done by the public education system.”

Reviews

Meryn Callander, author and co-founder of the Alliance for Transforming the Lives of Children:

“Gatto presents a credible case for his belief that school is an essential support system for a model of social engineering that condemns most people to be subordinate stones in a pyramidal social order, even though such a premise is a fundamental betrayal of the American Revolution.”

The Feingold Cookbook for Hyperactive Children

Written by AbleChild on February 17, 2022. Posted in Essential Books.

Dr. Ben Feingold, the pediatrician and allergist who wrote Why Your Child is Hyperactive, is a champion for dietary solutions to manage behavioral issues in children. In 1979, he published The Feingold Cookbook for Hyperactive Children. This book was developed on the basis that certain chemicals, such as artificial flavors, and artificial colors and preservatives that are in food can be detrimental to children, causing behavioral issues and interfering with learning ability. Feingold’s argument is that most neurotransmitters that affect mood and learning ability are developed in the gatrointestinal tract, from the foods we ingest. This book offers an alternative to pharmaceutical medication that has garnered successful results for many parents and children over the years, in achieving the goal of reduced hyperactivity in children, and improvements in the ability to focus.

The introduction of many of these “problem chemicals” in our foods began towards the end of Word War II, and Dr. Feingold was the first to notice how these chemicals triggered behavioral and learning issues due to their allergy-inducing properties. Some of the other symptoms Dr. Feingold observed at this time in patients of his were hives, asthma, headaches, stomach issues, urinary issues and nasal congestion.

The main food groups that the Feingold Diet eliminates are: 1) Synthetic (artificial) colors and flavors and preservatives BHT and BHA and 2) Fruits, vegetables and various other types of foods that contain natural salicylates. There are two stages for the diet. First, these two food groups are eliminated. Second, about 4 to 6 weeks later, if the child is responding with positive behavioral changes, food from the second group (salicylate fruits and vegetables) can be slowly re-introduced. But foods from the first group of synthetic flavors, colors and preservatives are not re-introduced at any point.

The Feingold Cookbook brings to light the scientific evidence that indicate diet can affect behavior and learning ability in children, and introduces a list of forbidden foods. And since it can be a challenge for many families to implement the dramatic changes the Feingold Diet requires, The Feingold Cookbook for Hyperactive Children offers helpful suggestions for recipes that have been used by families that follow this diet. Today, the Feingold Association has increased the Feingold food list to thousands of acceptable brand names of foods and non-food products.

About the Author

Dr. Ben Feingold is a pediatric allergist who taught pediatrics at Northwestern University Medical School in Chicago, and then moved to Los Angeles where he practiced pediatrics for 22 years. While in Los Angeles, Dr. Feingold served as chief of pediatrics at Cedars of Lebanon Hospital, was an associate in allergy at the Los Angeles Children’s Hospital, and an attending pediatrician at the Los Angeles County Hospital. His research has been a source of controversy and heavy discussion among certain bodies in government. But much of his research has been of much interest to the U.S. Senate and State of California. Dr. Feingold can be thanked for the removal of certain harmful substances from our food supply, as well as the increased safety in food production around the world.

Feingold’s research led to more research done by others, which suggested in 1980 that artificial food dyes might indeed adversely affect the behavior of children. In 1951, Dr. Feingold married his wife, Helene. Together, they wrote The Feingold Cookbook for Hyperactive Children, which was published in 1979, four years after Why Your Child is Hyperactive.

Dr. Feingold was born in Pittsburgh in 1900 and did his undergraduate and medical work at the University of Pittsburgh. He was an intern at Passavant Hospital in Pittsburgh, and then went on to serve as a fellow in pathology at the University of Gottingen in Germany in 1927, followed by a fellowship at the children’s clinic at the University of Vienna from 1928-1929.

Though Feingold is gone, the Feingold Foundation continues his valuable work and research, and you can find more information on their website.

Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medications

Written by AbleChild on September 1, 2021. Posted in Essential Books.

The withdrawal and long-term side effects of many psychiatric medications can cause symptoms that are similar or worse than the symptoms for which the patient is being medicated in the first place. Author Peter R. Breggin, along with David Cohen, Ph.D., were among the first to address these major issues, in this spectacular book which was way ahead of it’s time. Since the book’s first publication in 1999, there have been numerous studies confirming the harmful side effects and withdrawal symptoms of these drugs, and even the FDA acknowledges these problems.

Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medications goes into great detail, backed by thorough research, about the particular side effects and withdrawal symptoms for all different kinds of psychiatric medications; from antidepressants to mood stabilizers to stimulants. The book explains how doctor’s often do not take enough time to examine the patient, misdiagnose the patient, and as a result prescribe psychiatric drugs that are not needed, and often do more harm than good. This quick decision made by the doctor can impact years or even decades of a patient’s life. Your Drug May Be Your Problem educates patients and doctors about the correct way to gradually stop taking psychiatric drugs, and outlines the process for withdrawing from the medications. The book has also been fully updated to include new research studies and medications 0n the market.

About the Author

Peter R. Bregg, M.D., is a a psychiatrist who is very well known for helping set the stage for modern criticism of psychiatric treatments and psychotropic drugging. He has promoted so much success in the field of mental health that he has acquired the nickname “conscience of psychiatry.” HIs reform efforts began in the 1970s, and resulted in almost a complete cease in the use of procedures like lobotomy and psychosurgery in the Western World. Then in the 1990s, he and his wife Ginger were able to stop a federal eugenics project that was planned on America’s inner-city children. You can find more details about this in the book he co-authored with Ginger, The War Against Children of Color.

Breggin has been a full-time consultant at NIMH, as well as for the FAA. He has published over 20 books and numerous scientific articles. Some of his books include Toxic Psychiatry, The Antidepressant Factbook, and Talking Back to Prozac. His latest book is Covid-19 and the Global Predators: We are the Prey. Dr. Breggin is also the founder and director of The Center for the Study of Emphatic Therapy, Education and Living. He attended Harvard, and currently resides in Ithaca, NY. Find out more on his website, www.breggin.com.

No More Ritalin: Treating ADHD Without Drugs

Written by AbleChild on June 9, 2021. Posted in Essential Books.

With several million children still being prescribed ADHD drugs such as Ritalin every year, Dr. Mary Ann Block makes the case for why Ritalin (generic name methylphenidate) could be a huge risk to your child’s health. Block takes an avant-garde approach in No More Ritalin: Treating ADHD Without Drugs, not only questioning the very existence of the ADHD diagnosis, but she outlines safe and more effective drug-free alternative means of treatment. Block is of the school of thought that you can’t treat the problem until you identify the underlying causes of ADHD, such as hypoglycemia, allergies, environmental factors and hyperthyroidism. Often, symptoms stemming from issues such as these are misdiagnosed as ADHD. The book also lists commonly prescribed medications, explains what they are and the potential side effects they can have on children.

Block discusses in the book her belief that children diagnoses with ADHD are usually right-brain dominant in their information processing and learning styles, as well as being more creative than those with left-brain dominant styles. She explains the need for right-brain dominated children to be offered better accommodations with their learning styles in the school system. Block presents her arguments with thorough research and actual case histories from her clinic.

About the Author

Dr. Mary Ann Block is a top-selling author on family health, and director of the Block Center. Her medical approach is to look for and treat, whenever possible, the underlying causes of the problem, instead of using drugs to cover the symptoms. Her other books include No More ADHD, Just Because You’re Depressed, Doesn’t Mean You Have Depression, Depression is a Symptom Not a Disease, So Find the Cause — Fix the Problem, Today I Will Not Die, and The ABC’s of Raising Great Kids.

Dr. Block chairs The Health and Empowerment Committee for the National Foundation of Women Legislators. She is a State of Texas Family Practice Preceptor and served on the faculty as assistant professor at the University of North Texas Health Science Center/Texas College of Osteopathic Medicine in Fort Worth, Texas. Dr. Block is a regular contributor on TBN and FamilyNet’s Your Health with Dr. Richard Becker, as well as being quoted in magazines, newspapers, radio and TV shows across the country.

No More ADHD, 10 Steps to Help Improve Your Child’s Attention and Behavior WITHOUT Drugs

Written by AbleChild on June 1, 2021. Posted in Essential Books.

From the same top-selling author of Just Because You’re Depressed, Doesn’t Mean You Have Depression, Depression is a Symptom Not a Disease, So Find the Cause — Fix the Problem is a book that thoroughly investigates the truth about the ADHD diagnosis, and helps parents identify their child’s true health and learning problems and find non-pharmaceutical ways to improve these issues. Block reveals what’s behind the origin of the medical profession’s label of ADHD, question’s the disorder’s medical legitimacy, and shows how children’s attention and behavior symptoms can be the result of real and explainable health and learning problems.

Dr. Block is an outspoken critic of children being diagnosed with ADHD and the dangers of the psychiatric drugs being prescribed to treat children. She advises parents to make sure their children are thoroughly examined by a medical professional to find underlying medical problems that could be misdiagnosed as a mental disorder.

Dr. Block is a mother who knows from personal experience how the medical system can fail a child. Her daughter became seriously ill following an incorrect diagnosis from doctors and inappropriate use of pharmaceutical drugs. This compelled her to attend medical school at the age of 39 to save her daughter. Dr. Block’s perspective as both a parent and a physician should set many parents at ease and give them confidence in her advice in this book.

About the Author

Dr. Mary Ann Block is a licensed osteopathic physician and top-selling author on family health, and director of the Block Center. Her other books include No More Ritalin, No More Amoxicillin, Today I Will Not Die, and The ABC’s of Raising Great Kids.

Just Because You’re Depressed, Doesn’t Mean You Have Depression, Depression is a Symptom Not a Disease, So Find the Cause — Fix the Problem

Written by AbleChild on May 25, 2021. Posted in Essential Books.

In this book, Dr. Mary Ann Block uses a clear and easy to understand writing style to expose the truth about the diagnosis of depression, and the dangers of the current medications prescribed for it. If you or someone you love is among the 300 million people diagnosed with or suffering from the symptoms of depression, the information from this book could literally save your life. In the book, Block examines the often flawed area of psychiatry with a fine-tooth comb, to help people understand the real issues underlying their symptoms. Having the right information then allows you to make an educated decision.

Block’s book outlines the six most common causes of depression that she has seen among her patients. They are as follows:

Thyroid Problems
Hormone Deficiencies
Magnesium and Other Nutritional Deficiencies
Allergies
Prescription Drug Side-Effects
A Personal Loss or Other Normal Life Cycle Experience

Other important points covered in Block’s book include:

Postpartum depression, and how it is a hormonal imbalance, not something that requires treatment with anti-depressants.
How poor nutrition can impact your mood and lead to symptoms of depression.

Block also reviews the many side effects of anti-depressants, which include depression, heart failure, heart attack, atrial fibrillation, cerebral embolism, stroke, shock, thrombosis, ventricular arrythmia, venticular fibrillation, hemorrhage, coma, delusions, abnormal EEG, hypertension, angina pectoris, agitation, sleep disorder, apathy, ataxia, hallucinations, hostility, paranoid reactions, personality disorder, psychosis, vertigo, antisocial behavior and stupor.

About the Author

Dr. Mary Ann Block is a top-selling author on family health, and director of the Block Center. Her medical approach is to look for and treat, whenever possible, the underlying causes of the problem, instead of using drugs to cover the symptoms. Her other books include No More ADHD, No More Ritalin, Today I Will Not Die, and The ABC’s of Raising Great Kids.

Reviews

David Brown Stein, M.D., author of Overcoming Thyroid Disorders and Drugs That Don’t Work, and Natural Therapies That Do

“This book is a must read for those who have been diagnosed with depression. This book gives the reader all the information they need to make the best choices about how to find the real cause of their symptoms. I highly recommend this book by Dr. Mary Ann Block.”

AbleChild’s Statement on Informed Consent as it Relates to Covid and Consumer Safety

Written by AbleChild on February 16, 2021. Posted in Articles, MedWatch.

AbleChild has worked diligently throughout the years on informing the public on the importance of Informed Consent and an individual’s right to be given all necessary information (full disclosures on diagnosis, benefits, risks, alternatives) regarding psychiatric drugs and children. Informed Consent is no less important as it overlaps many different issues and comes back to overall public safety.

Is the 14-Year-Old Shooting Suspect in West Oak Middle School, SC Another Failed Outcome of Mental Health Treatment?

Written by Able Child on September 29, 2016. Posted in Violence.

The 14-year old suspect in the Townville Elementary School shooting was expelled from West-Oak Middle School after bringing a hatchet to school last year, according to news reports.

West Oak Middle School expulsion policy requires the school to refer the student to the department of juvenile justice based on the fact he brought a weapon to school. The DJJ process clearly indicates the suspect would have undergone a mental health evaluation and had plenty of access to mental health treatment prior to the shooting.

What’s not clear, did the suspect receive mental health services and psychiatric drug treatment prior to the Hatchet incident at school? It is often difficult to gain access to early mental health treatment records. However, the public did gain access to the Sandy Hook mass shooter’s early mental health treatment records through the Child Advocate’s report, but didn’t gain access to the last five years leading up to the mass murder at Sandy Hook. The State is still withholding those records.

Lanza’s primary treating psychiatrist, Paul Fox, who surrendered his license to practice is now facing felon charges for sexual abuse of a former patient. Fox told police during the Sandy Hook police investigation he still retains the billing records, but destroyed the actual mental health records of Lanza. Fox failed to follow record retention law and public notification law that he was no longer practicing. Connecticut didn’t enforce either one of those laws.

The Child Advocate’s report on Lanza actually showed he had plenty of access to mental health and participated in the birth to three mental health programs. In addition, Lanza was home bound through Newtown public school system and under the care of discredited psychiatrist Fox at that time. Dr. Robert King of Yale Child Study Center also treated Adam Lanza. Dr. King is heavily involved in landmark mental health research that involves FDA approval.

The public would benefit from mental health billing information, the Yale file, and the diary of the mother, Nancy Lanza, found at the crime scene.

Dr. Robert King and Nancy Koenig of Yale claimed that Nancy Lanza refused treatment for her son; however, the police report indicates that Nancy Lanza reported an adverse drug event to Yale’s Koenig and Dr. King. There was no indication that Dr. King or Koenig advised Nancy Lanza to report the adverse drug event to the FDA, instead Dr. King and Koenig of Yale labeled Nancy Lanza as noncompliant.

Time again the school shootings are linked to mental health “treatment” and deadly outcomes. This is an excellent time to question the condition of the mental health system, and ask two fundamental questions. Is the policies pushed in the aftermath of Sandy Hook of aggressive outpatient services, and “shy of forced medication” actually increasing our mental health crisis and the deadly outcomes? The second question, Are public health departments, like Connecticut, protecting behavioral health vendors, bad psychiatrists, and covering up dangerous, experimental mental health treatment on children in crisis?

AbleChild contacted the SC Anderson County Sheriff’s office to encourage them to explore the psychiatric drug link, question the treating psychiatrist, and investigate any behavioral health vendor involvement. AbleChild also asked if the suspect’s blood was taken at time of arrest. The Sheriff’s office thanked AbleChild for our suggestions and didn’t have the information on the blood work up at this time.

When No One Acts in the 21 Century, Losing Informed Consent

Written by Able Child on July 9, 2015. Posted in Lawmaking.

Do not underestimate your power.

Shocking lobbyist’s bill moves quickly without public input. Informed Consent on the chopping block and a fast track to human experimentation. AbleChild strongly opposes this proposed bill.

AbleChild encourages you to contact Chairman Fred Upton (R) and Diana DeGette (D) and your representative to voice opposition to H.R. 6.

Do not underestimate your power! Call and Opposes H.R. 6! Simply put it, I support informed consent and human rights and reject lobbyist’s dream bill H.R 6.

The 21st Century Cures Act
June 10, 2015

Interactive Guide to the #Cures2015 Legislation

WASHINGTON, DC – The House Energy and Commerce Committee recently voted 51-0 approving H.R. 6, the 21st Century Cures Act. This nonpartisan legislation is a product of more than a year of working with patients, advocates, researchers, innovators, and health care professionals to bring our nation’s laws up to speed with advances in medicine and technology. Over a year ago, Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) began the 21st Century Cures conversation to discuss the many incredible scientific advancements and breakthrough studies happening each day and how those can be used to find cures and therapies for the thousands of conditions and diseases without them.

The 21st Century Cures Act accelerates the discovery, development, and delivery of life saving and life improving therapies and transforms the quest for faster cures by:

Removing barriers to increased research collaboration.
Incorporating the patient perspective into the drug development and regulatory review process.

Measuring success and identifying diseases earlier through personalized medicine.
Modernizing clinical trials.

Removing regulatory uncertainty for the development of new medical apps.

Providing new incentives for the development of drugs for rare diseases.

Helping the entire biomedical ecosystem coordinate more efficiently to find faster cures.

Investing in 21st Century science and next generation investigators.

HR 6 helps keep and create jobs here at home.
– See more at: http://energycommerce.house.gov/press-release/21st-century-cures-act#sthash.C2XUUSwt.dpuf