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Calls Come For FDA ADHD Panel Member to Step Down

Patricia Weathers
(845) 677-8115

Sheila Matthews
National Vice President
(203) 966-8419

Victims and Advocates who plan on testifying before the February 9th FDA Risk Management Advisory Review Panel on ADD Drugs’ Link to Deaths, Heart Attacks are asking for one of it’s panel members to step down due to a concern over a conflict of interest. Stephanie Crawford, an associate professor at the University of Illinois at Chicago College of Pharmacy has been selected to sit on the advisory panel to weigh-in on ADD Drug Risks.

Parent and child advocates question Ms. Crawford’s longstanding affiliation with the University of Illinois and its long history with ADHD Research. The University of Illinois receives millions of dollars in Attention Deficit Drug Research. Both ADD and ADHD known as Attention Deficit Disorder with or without hyperactivity are subjective psychiatric labels for which there are no demonstrable objective tests. Without legitimate scientific testing to verify the existence of these labels, researchers have resorted to using highly subjective questionnaires, surveys, or rating scales in determining a diagnosis. A widely used and controversial rating scale, the “Acter’s profile for boys (or girls)” comes from the University of Illinois and its research department. This one screening method or random survey is being unlawfully used within the public education system without the approval of any Local, State, or Federal Government to diagnose school children throughout the United States . These research screenings are being casually passed off to parents and school personnel without full informed consent and are currently being legally challenged within Federal Courts. “Parents are simply not being told that their children are participating in research,” says Sheila Matthews Founder of Ablechild a non-profit organization.

Ms. Crawford’s own participation in ADHD Research under grant application PA-98004 Drug Abuse and ADHD in Adults and Their High Risk Offspring further demonstrates the just cause for her removal from the panel. Though the FDA has a conflict of interest screening process and waiver criteria, there are still some conflicts of interest that are simply not manageable and should be challenged.

To have a panel member that works for this particular University that receives a tremendous amount of pharmaceutical and psychiatric financial support to conduct research on this very same label defeats the purpose, authority, and function of the panel itself.

Prozac Backlash: Trouble in Prozac

Fortune Magazine, by David Stipp

Can Prozac make you want to die? The idea seems strange, given that the drug and similar antidepressants are supposed to do just the opposite. Yet that is what Kimberly Witczak believes happened to her husband. Two years ago Tim “Woody” Witczak killed himself at age 37, soon after going on Pfizer’s Zoloft–the top-selling member of Prozac’s class of drugs, known as selective serotonin reuptake inhibitors, or SSRIs. Her husband was an upbeat, happy man, says Kim Witczak. Shortly before his death he had been named vice president of sales at a startup that sold energy-efficient lighting. When anxiety about the new job caused insomnia, he was prescribed Zoloft. He began suffering from nightmares, profound agitation, and eerie sensory experiences after a couple of weeks on the medicine–at one point, she says, he said he felt as if his head were detached from his body. Then he seemed to calm down. But about five weeks after his first dose, he hanged himself from the rafters in their garage when Kim was out of town. He left no suicide note.

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Television Adverts for Antidepressants Cause Anxiety

From New Scientist Print Edition

ADVERTS that claim depression is caused by a chemical imbalance, and that antidepressants correct it, are false and should be banned, say two mental health specialists.

Popular antidepressants such as Prozac and Celexa block the uptake of the neurotransmitter serotonin and have been shown to be slightly better than placebo in treating depression. But low serotonin levels are no more the cause of depression than low aspirin levels are the cause of headaches, argue Jonathan Leo at Lake Erie College of Osteopathic Medicine in Bradenton, Florida, and Jeffrey Lacasse at Florida State University in Tallahassee (Public Library of Science Medicine, DOI: 10.1371/journal.pmed.0020392).

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Drug Industry Human Testing Masks Death, Injury, Compliant FDA

Nov. 2 (Bloomberg) — Oscar Cabanerio has been waiting in an experimental drug testing center in Miami since 7:30 a.m. The 41- year-old undocumented immigrant says he’s desperate for cash to send his wife and four children in Venezuela.

More than 70 people have crowded into reception rooms furnished with rows of attached blue plastic seats. Cabanerio is one of many regulars who gather at SFBC International Inc.’s test center, which, with 675 beds, is the largest for-profit drug trial site in North America.

Across the U.S., 3.7 million people have enrolled in drug tests sponsored by the world’s largest pharmaceutical companies. The companies have outsourced 75 percent of experimental drug trials to centers like SFBC, a leader in a $14 billion industry.

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Generation Ritalin

Doctors are at odds over the treatment of children affected by ADHD … to drug them or not to drug them?

Michelle Wiese Bockmann reports.

At the age of 10, Brandon Frances screamed for hours on end, suffered psychotic episodes and daily beat his mother.

A pediatrician in Perth diagnosed Brandon with attention deficit hyperactivity disorder when he was four, and for the next seven years he was constantly medicated with a cocktail of up to six different drugs to control his behaviour.

Now 13, Brandon no longer takes the medication, is behaving and doing well at school. Eighteen months ago doctors at a Perth public hospital clinic found Brandon did not have ADHD, but a learning disorder. His entire treatment was changed.

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Rutherford Institute Attorneys Sue Indiana School for Conducting Mental Health Screening Exam on Teenager Without Parental Consent

South Bend, IN—Attorneys for The Rutherford Institute have filed a lawsuit in U.S. District Court for the Northern District of Indiana on behalf of an Indiana family whose 15-year-old daughter, Chelsea Rhoades, was subjected to a mental health screening examination at school without her parents’ knowledge or consent.

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Fierce Opposition Arises to Mental Health Screening in Schools

By Karen MacPherson, Pittsburgh Post-Gazette

WASHINGTON — Back in 2003, a federal commission created by President Bush recommended improving and expanding mental health programs in schools to provide help as early as possible to students with learning problems or those who might turn violent or disruptive.

The commission highlighted one means of early diagnosis, the Columbia University “TeenScreen” program, that allows students — with parental permission — to get a mental health “check-up” via a computer-based questionnaire before graduating from high school.

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Are ADHD Drugs Safe? Report Finds Little Proof

M. ALEXANDER OTTO; The News Tribune

At a time when millions of children and adults are taking drugs for Attention Deficit Hyperactivity Disorder, the most comprehensive scientific analysis of the drugs to date has found little evidence that they are safe, that one drug is more effective than another or that they help school performance. The 27 drugs studied included Adderall, Concerta, Strattera, Ritalin, Focalin, Cylert, Provigil, and others that, in some households, are well-known for their sometimes calming affects.

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In Over-drugging Kids, ‘Cure’ Is Worse Than Disease

By Noelle Talevi

There is a deadly connection between mind-altering, psychiatric drugs and violent, suicidal behavior.

David Burgos, the young man who recently committed suicide in a Connecticut correctional facility, had been diagnosed with bipolar disorder and attention deficit disorder. What mind-altering drugs was he on, and how long was he on them? David was in the custody of the Department of Children and Families since the age of 10. The majority of children under this agency’s control are on at least one, if not a cocktail, of psychiatric drugs. No one knows the exact number of children, because no one in Connecticut keeps track.

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American Medical Association Endorses Drug Experiments on Children

Sheila Matthews
National Vice President
(203) 966-8419

 The American Medical Association has issued a report advocating the training of investigators to study the effects of psychotropic drugs on children, adolescents, and young adults. According to the AMA, “SSRIs should remain available for use in children and adolescents, including for unlabeled uses.” SSRIs were a popular class of antidepressants that have been the subject of widespread controversy, banned in Great Britain in 2003 for use in children and adolescents due to their propensity to induce suicidal thoughts and ideations, and more recently given black box labels in 2004 by the Food and Drug Administration.

The AMA’s statements indicate that it views both the FDA Black Box Suicide Warning on these drugs, and the issue of full informed consent as a restriction. This comes despite their conclusions that “The use of antidepressants is associated with a doubling in the number of reports indicative of suicidal thinking and behavior in children and adolescents with Major Depressive Disorder and other psychiatric disorders.”

Ablechild contacted the FDA to obtain a comment regarding the AMA’s report which promotes the experimental use of drugs that are known to increase suicidal tendencies. According to FDA Spokesperson, Susan Cruzan, “The FDA has reviewed all the scientific data and incorporated two advisory boards’ recommendations on the link to suicide ideation, resulting in a Black Box Warning recommending close oversight for all that use antidepressants to look for increased suicide ideation. The FDA worked with the manufacturers on the Black Box warning mandated on all antidepressants.”

According to Bill Hall, Health & Human Services Spokesman, “HHS regulates all human subjects research carried out by those institutions and organizations that have signed assurances with the HHS Office for Human Research Protections (OHRP).” Unfortunately, OHRP is not funded to track all unlabeled usage of psychotropic drugs as promoted by the AMA in their recent report.

Based on the statements of both organizations we have concluded that there is insufficient oversight of experimental use of psychotropic drugs on children.

OHRP must protect all citizens from becoming unknowing victims of experimental research.

The promotion of unlabeled SSRI use on children by the AMA, when the dangers and risks associated with the usage is well documented, is unethical and irresponsible. It undermines the FDA’s role, its recommendations, and jeopardizes overall public health.

The AMA needs to be reminded that disclosing drug risks to the public and promoting full disclosure should not be seen as a barrier, but as requisite to public health and safety.