(CBS) Jim and Star Chavez didn't think twice when their doctor prescribed Advair for their son Ethan.
Inhaled daily, Advair was supposed to prevent his occasional mild asthma attacks. Instead, as CBS News Correspondent Sharyl Attkisson reports, shortly after he started using Advair, Ethan collapsed.
"He was totally lifeless," says Jim Chavez. "His eyes were rolled back in his head, and it was really terrifying."
"I shook him, and I kept on shaking him and kept on yelling his name, 'Ethan, Ethan, wake up, wake up,' and he wouldn't respond at all," says Star Chavez.
They didn't know it then, but asthma patients taking the same medicine in a study were dying in unexpected numbers.
Drugmaker GlaxoSmithKline led a study of Salmeterol, the medicine in Advair and another Glaxo asthma product, Serevent. Designed to relieve asthma, it seemed to trigger fatal attacks in some. Three times more patients taking the medicine died of asthma than those not taking it.
A safety monitoring board took one look at the deaths and shut down Glaxo's study. The FDA recently forced Glaxo to disclose the small but significant risk of death in a black box warning on its medicine and in ads: "Rare but serious asthma episodes and asthma related fatalities occurred."
In the study, Glaxo found deaths among blacks were the highest, though white deaths were also elevated. Glaxo then sent out a carefully worded message that led some to believe white patients need not worry: "These risks may be greater in African-Americans."
Yet CBS News has learned a study ten years ago of only white patients also found an increase in asthma deaths. Glaxo dismissed the deaths back then as "probably due to the disease rather than the treatment."
Most people who use Advair have no serious problems, and the FDA says benefits outweigh risks. And despite the new warnings, sales have increased, approaching $2 billion a year.
And that black box warning ordered for Advair four months ago still isn't on the product. The FDA says Glaxo negotiated when it will be but won't tell CBS News the date.
Ethan has fully recovered from his trauma, and the whole family is breathing easier without the asthma remedy that may have been worse than the disease.
Thursday, May 24, 2007
You can find the federal bill here http://thomas.loc.gov/ by typing in HR 2387
Parental Consent Act of 2007 (Introduced in House)
Mr. PAUL (for himself, Mr. MILLER of Florida, Mr. EVERETT, Mr. BURTON of Indiana, Mrs. BLACKBURN, Mr. HUNTER, Mr. SIMPSON, Mr. MCCOTTER, Mr. NEUGEBAUER, Mr. HENSARLING, Mr. BARTLETT of Maryland, Mr. TANCREDO, and Mr. DOOLITTLE) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
- Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
- This Act may be cited as the `Parental Consent Act of 2007'.
SEC. 2. FINDINGS.
- The Congress finds as follows:
- (1) The United States Preventive Services Task Force (USPSTF) issued findings and recommendations against screening for suicide that corroborate those of the Canadian Preventive Services Task Force. `USPSTF found no evidence that screening for suicide risk reduces suicide attempts or mortality. There is limited evidence on the accuracy of screening tools to identify suicide risk in the primary care setting, including tools to identify those at high risk.'.
- (2) The 1999 Surgeon General's report on mental health admitted the serious conflicts in the medical literature regarding the definitions of mental health and mental illness when it said, `In other words, what it means to be mentally healthy is subject to many different interpretations that are rooted in value judgments that may vary across cultures. The challenge of defining mental health has stalled the development of programs to foster mental health (Secker, 1998). . . .'.
- (3) A 2005 report by the National Center for Infant and Early Childhood Health Policy admitted, with respect to the psychiatric screening of children from birth to age 5, the following: `We have mentioned a number of the problems for the new field of IMH [Infant Mental Health] throughout this paper, and many of them complicate examining outcomes.'. Briefly, such problems include:
- (A) Lack of baseline
- (B) Lack of agreement about diagnosis.
- (C) Criteria for referrals or acceptance into services are not always well defined.
- (D) Lack of longitudinal outcome studies.
- (E) Appropriate assessment and treatment requires multiple informants involved with the young child: parents, clinicians, child care staff, preschool staff, medical personnel, and other service providers.
- (F) Broad parameters for determining socioemotional outcomes are not clearly defined, although much attention is now being given to school readiness.
- (4) Authors of the bible of psychiatric diagnosis, the Diagnostic and Statistical Manual, admit that the diagnostic criteria for mental illness are vague, saying, `DSM-IV criteria remain a consensus without clear empirical data supporting the number of items required for the diagnosis. . . . Furthermore, the behavioral characteristics specified in DSM-IV, despite efforts to standardize them, remain subjective. . . .' (American Psychiatric Association Committee on the Diagnostic and Statistical Manual (DSM-IV 1994), pp. 1162-1163).
- (5) Because of the subjectivity of psychiatric diagnosis, it is all too easy for a psychiatrist to label a person's disagreement with the psychiatrist's political beliefs a mental disorder.
- (6) Efforts are underway to add a diagnosis of `extreme intolerance' to the Diagnostic and Statistical Manual. Prisoners in the California State penal system judged to have this extreme intolerance based on race or sexual orientation are considered to be delusional and are being medicated with anti-psychotic drugs. (Washington Post 12/10/05)
- (7) At least one federally-funded school violence prevention program has suggested that a child who shares his or her parent's traditional values may be likely to instigate school violence.
- (8) Despite many statements in the popular press and by groups promoting the psychiatric labeling and medication of children, that ADD/ADHD is due to a chemical imbalance in the brain, the 1998 National Institutes of Health Consensus Conference said, `. . . further research is necessary to firmly establish ADHD as a brain disorder. This is not unique to ADHD, but applies as well to most psychiatric disorders, including disabling diseases such as schizophrenia. . . . Although an independent diagnostic test for ADHD does not exist. . . . Finally, after years of clinical research and experience with ADHD, our knowledge about the cause or causes of ADHD remains speculative.'.
- (9) There has been a precipitous increase in the prescription rates of psychiatric drugs in children:
- (A) The use of antipsychotic medication in children has increased nearly fivefold between 1995 and 2002 with more than 2.5 million children receiving these medications, the youngest being 18 months old. (Vanderbilt University, 2006)
- (B) More than 2.2 million children are receiving more than one psychotropic drug at one time with no scientific evidence of safety or effectiveness. (Medco Health Solutions, 2006)
- (C) More money was spent on psychiatric drugs for children than on antibiotics or asthma medication in 2003. (Medco Trends, 2004)
- (10) A September 2004 Food and Drug Administration hearing found that more than two-thirds of studies of antidepressants given to depressed children showed that they were no more effective than placebo, or sugar pills, and that only the positive trials were published by the pharmaceutical industry. The lack of effectiveness of antidepressants has been known by the Food and Drug Administration since at least 2000 when, according to the Food and Drug Administration Background Comments on Pediatric Depression, Robert Temple of the Food and Drug Administration Office of Drug Evaluation acknowledged the `preponderance of negative studies of antidepressants in pediatric populations'. The Surgeon General's report said of stimulant medication like Ritalin, `However, psychostimulants do not appear to achieve long-term changes in outcomes such as peer relationships, social or academic skills, or school achievement.'.
- (11) The Food and Drug Administration finally acknowledged by issuing its most severe Black Box Warnings in September 2004, that the newer antidepressants are related to suicidal thoughts and actions in children and that this data was hidden for years. A confirmatory review of that data published in 2006 by Columbia University's department of psychiatry, which is also the originator of the TeenScreen instrument, found that `in children and adolescents (aged 6-18 years), antidepressant drug treatment was significantly associated with suicide attempts . . . and suicide deaths. . . . '. The Food and Drug Administration had over 2000 reports of completed suicides from 1987 to 1995 for the drug Prozac alone, which by the agency's own calculations represent but a fraction of the suicides. Prozac is the only such drug approved by the Food and Drug Administration for use in children.
- (12) Other possible side effects of psychiatric medication used in children include mania, violence, dependence, weight gain, and insomnia from the newer antidepressants; cardiac toxicity including lethal arrhythmias from the older antidepressants; growth suppression, psychosis, and violence from stimulants; and diabetes from the newer anti-psychotic medications.
- (13) Parents are already being coerced to put their children on psychiatric medications and some children are dying because of it. Universal or mandatory mental health screening and the accompanying treatments recommended by the President's New Freedom Commission on Mental Health will only increase that problem. Across the country, Patricia Weathers, the Carroll Family, the Johnston Family, and the Salazar Family were all charged or threatened with child abuse charges for refusing or taking their children off of psychiatric medications.
- (14) The United States Supreme Court in Pierce versus Society of Sisters (268 U.S. 510 (1925)) held that parents have a right to direct the education and upbringing of their children.
- (15) Universal or mandatory mental health screening violates the right of parents to direct and control the upbringing of their children.
- (16) Federal funds should never be used to support programs that could lead to the increased over-medication of children, the stigmatization of children and adults as mentally disturbed based on their political or other beliefs, or the violation of the liberty and privacy of Americans by subjecting them to invasive `mental health screening' (the results of which are placed in medical records which are available to government officials and special interests without the patient's consent).
SEC. 3. PROHIBITION AGAINST FEDERAL FUNDING OF UNIVERSAL OR MANDATORY MENTAL HEALTH SCREENING.
- (a) Universal or Mandatory Mental Health Screening Program- No Federal funds may be used to establish or implement any universal or mandatory mental health, psychiatric, or socioemotional screening program.
- (b) Refusal to Consent as Basis of a Charge of Child Abuse or Education Neglect- No Federal education funds may be paid to any local educational agency or other instrument of government that uses the refusal of a parent or legal guardian to provide express, written, voluntary, informed consent to mental health screening for his or her child as the basis of a charge of child abuse, child neglect, medical neglect, or education neglect until the agency or instrument demonstrates that it is no longer using such refusal as a basis of such a charge.
- (c) Definition- For purposes of this Act, the term `universal or mandatory mental health, psychiatric, or socioemotional screening program'--
- (1) means any mental health screening program in which a set of individuals (other than members of the Armed Forces or individuals serving a sentence resulting from conviction for a criminal offense) is automatically screened without regard to whether there was a prior indication of a need for mental health treatment; and
- (2) includes--
- (A) any program of State incentive grants for transformation to implement recommendations in the July 2003 report of the President's New Freedom Commission on Mental Health, the State Early Childhood Comprehensive System, grants for TeenScreen, and the Foundations for Learning Grants; and
- (B) any student mental health screening program that allows mental health screening of individuals under 18 years of age without the express, written, voluntary, informed consent of the parent or legal guardian of the individual involved.
Tuesday, May 22, 2007
Fox National News exposes the link between psychiatric drugs and school shootings:
Click here to watch 3 min. video: http://www.youtube.com/watch?v=9S-7aNPf33A
Filmmaker Michael Moore calls for a federal investigation into school shooters and psychiatric drugs:
Click here to watch 3 min. video: http://www.youtube.com/watch?v=dSZ9YTnSkLc
In September 2005, following confirmation that Red Lake Indian Reservation school shooter, Jeff Weise, was under the influence of the antidepressant Prozac, the National Foundation of Women Legislators called for a Congressional investigation into the
correlation between psychiatric drug use and school massacres.
correlation between psychiatric drug use and school massacres.
Congress has yet to investigate the role of psychiatric drugs relating to school shootings despite international drug regulators warning these drugs can cause mania, psychosis, hallucinations, suicide and homicidal ideation.
At least eight of the recent school shooters were under the influence of such drugs, and according to media reports, investigators working on the Virginia Tech school shootings claim Cho Seung-Hui may also have been taking
drugs for "depression."
drugs for "depression."
Click here to send a form letter to your Congressman (and Speaker Pelosi) requesting they act and call for a full investigation.