Written by Able Child on . Posted in Lawmaking.
WASHINGTON – Sen. Chuck Grassley is asking the drug maker, Eli Lilly and Company, for information related to the risks and marketing of the anti-psychotic drug Zyprexa.
Grassley made this request in response to allegations that the company downplayed safety risks and engaged in other improper marketing practices that may be jeopardizing patients’ health. The text of Grassley’s letter follows here.
Written by Able Child on . Posted in Lawmaking, MedWatch.
By Milt Freudenheim, The New York Times.
Drug advertising aimed at consumers, a fast-growing category that reached $4.5 billion last year, will face hard scrutiny in the new Congress, according to industry critics in both the House and Senate.
The consumer ads will be on the griddle early in this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it.
Written by Sheila Matthews on . Posted in MedWatch, Violence.
Patricia Weathers
President
www.ablechild.org
(845) 677-8115
Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419
Three school shootings in the past week have left 11 dead and 29 wounded, prompting the Bush administration to call for a school violence summit with education and law enforcement officials to help communities prevent violence and deal with its aftermath. Yet parents and legislators say that the government has consistently ignored the correlation between school shooters and psychiatric drug use and are likely to do so again at the upcoming summit.
Last year, following the Red Lake Minnesota school shootings and the revelation that the shooter Jeff Weise was under the influence of the antidepressant Prozac, a coalition of Tribal leaders and National Foundation of Women Legislators (NFWL) issued a joint resolution calling on Congress to fully investigate the correlation between psychiatric drug use and school shooters that had left 29 dead and 62 wounded. Ablechild also requested an investigation at that time.
The joint resolution called for such an investigation “to include all autopsies, toxicology reports, dosages of drugs that school shooters were either taking or withdrawing from, and testimony from medical experts who have exposed the dangers of these events”.
To date Congress has not acted upon this request. Nearly a year later, the Rocky Mountain News reported that Colorado school shooter Duane Morrison had an antidepressant in his car. Morrison took several girls hostage, killing one of them before committing suicide.
The evidence tying psychiatric drugs to acts of violence continues to mount; the FDA has warned that antidepressants can cause suicidal ideation, mania, and psychosis. The manufacturers of one antidepressant, Effexor, warn the drug can cause homicidal ideation. And earlier this month a study published in the Public Library of Science-Medicine journal found that the antidepressant Paxil raises the risk of violence. Though the study focuses specifically on Paxil, the researchers concluded that antidepressant drugs such as Prozac, Celexa, and Zoloft most likely pose the same risk. Lead researcher of the study, Dr. David Healy, director of Cardiff’s University’s North Wales Department of Psychological Medicine stated, “We’ve got good evidence that the drugs can make people violent and you’d have to reason from that that there may be more episodes of violence.”
AbleChild.org, a national grassroots parent’s organization, calls on all concerned citizens to contact their federal representatives, urging them to conduct a full investigation into the link between the spate of school shootings and possible psychiatric drug use of the shooters. Furthermore, state officials must demand full toxicology reports on all three recent school shooters to determine psychiatric drug usage or withdrawal. The victim’s families and the public at large deserve no less.
Written by Able Child on . Posted in Lawmaking.
In a resounding affirmation of personal liberty and freedom, the Alaska Supreme Court issued its long-awaited decision in Myers v. Alaska Psychiatric Institute today. The court found Alaska’s forced psychiatric drugging regime to be unconstitutional when the state forces someone to take psychiatric medications without proving it to be in their best interests or when there are less restrictive alternatives.
Faith Myers, the appellant in the case, reacted to the decision saying, “It makes all of my suffering worthwhile.”
Written by Able Child on . Posted in MedWatch.
By LINDA A. JOHNSON, Associated Press Writer
Accidental overdoses and side effects from attention deficit drugs likely send thousands of children and adults to emergency rooms, according to the first national estimates of the problem.
Scientists at the U.S. Centers for Disease Control and Prevention estimated problems with the stimulant drugs drive nearly 3,100 people to ERs each year. Nearly two-thirds — overdoses and accidental use — could be prevented by parents locking the pills away, the researchers say.
Written by Able Child on . Posted in MedWatch.
Joseph Rhee Reports:
ABC News has learned that a Massachusetts hospital is currently recruiting pre-schoolers to test the safety and effectiveness of a powerful antipsychotic drug called Quetiapine. (SEROQUEL AstraZeneca – Vince)
The study, conducted by the Department of Pediatric Psychopharmacology at Massachusetts General Hospital, is testing subjects from four to six years of age with Bipolar Disorder. An earlier Massachusetts General study of the antipsychotic drugs Risperidone and Olanzapine recruited children as young as three years old.
Written by Able Child on . Posted in MedWatch.
CHILDREN as young as five have suffered strokes, heart attacks and hallucinations after taking drugs to treat attention deficit hyperactivity disorder (ADHD).
Almost 400 serious adverse reactions to the two most used ADHD drugs, Ritalin and Dexamphetamine, had been reported to the Therapeutic Goods Administration (TGA), The Australian reported today.
Almost 60 of the adverse reaction reports dating back to 1980, obtained under freedom of information laws, involved children under the age of 10, the newspaper said.
Written by Able Child on . Posted in MedWatch.
By Gardiner Harris
GAITHERSBURG, Md., Feb. 9 — Stimulants like Ritalin could have dangerous effects on the heart, and federal regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal advisory panel voted on Thursday.
The panel’s recommendation promises to intensify a long-running debate about whether the medicines are overused. Nearly four million patients take the drugs to treat attention deficit disorder and hyperactivity, and committee members said they wanted to slow explosive growth in the drugs’ use.
Written by Able Child on . Posted in MedWatch.
(Reuters) WASHINGTON – Deaths of 51 U.S. patients who took widely prescribed drugs to treat attention deficit disorder prompted regulators to start watching for heart attacks, high blood pressure and other problems in 2004, a report released on Wednesday said.
The U.S. Food and Drug Administration staff did not say the drugs were responsible for the fatalities, but they urged close monitoring for “the rare occurrence of pediatric sudden death during stimulant therapy.”
Written by Sheila Matthews on . Posted in Lawmaking, MedWatch.
Patricia Weathers
President
www.ablechild.org
(845) 677-8115
Sheila Matthews
National Vice President
www.ablechild.org
(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.
