Lawmaking Archives - Page 8 of 11

Parental Consent Act of 2007 (Introduced in House)

Written by Sheila Matthews on April 4, 2007. Posted in Lawmaking.

110th CONGRESS 1st Session H. R. 2387 To prohibit the use of Federal funds for any universal or mandatory mental health screening program. IN THE HOUSE OF REPRESENTATIVES May 17, 2007 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

A BILL

To prohibit the use of Federal funds for any universal or mandatory mental health screening program.

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.

(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.

(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.

Connecticut Aims to Pass Second Landmark Law

Written by Sheila Matthews on March 4, 2007. Posted in Lawmaking, MedWatch.

Regarding Parent Protections & Psychiatric Products and Services

Proposed Bill 6202, LCO No 919
AN ACT CONCERNING PSYCHIATRIC AND PSYCHOLOGICAL TESTING OF SCHOOL CHILDREN AND PROCEDURAL SAFEGUARDS FOR PARENTS

ep_07_03_00_connecticut — AbleChild.org, Cofounder Sheila Matthews with Bill Sponsor Representative Hetherington at New Canaan Chamber of Commerce Luncheon displays New Parent Protection Bill regarding Informed Consent and the Right to Refuse Psychiatric Testing in Public Schools. To learn more about Proposed Bill 6202, parent rights relating to psychiatric testing and drug use visit www.ablechild.org

Background

In 2001 the State of Connecticut passed the first law in the Country that prohibited school personnel from recommending psychiatric drugs to parents for their children, Public Act 01-124. Connecticut legislation stood as a model where other States quickly followed with similar legislation. This law fueled a national movement that resulted in the Federal law “The Child Medication Safety Act”, which received overwhelming support from both political parties.
Contact: Sheila Matthews (203) 966-8419
www.ablechild.org

Grassley Seeks Marketing and Safety Documents From Major Drug Maker

Written by Able Child on February 14, 2007. 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.

Showdown Looms in Congress Over Drug Advertising on TV

Written by Sheila Matthews on January 22, 2007. Posted in Lawmaking, MedWatch.

New York Times
By: MILT FREUDENHEIM
Published: January 22, 2007

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.

The pharmaceutical industry, which often gets what it asks for from Congress and the executive branch, seeks to renew the law and add a new set of user fees that would be pay salaries for additional F.D.A. employees to evaluate all consumer drug ads, before they are shown on television. Both the industry and its critics agree that there should be a pause before the advertising starts — to allow time for doctors to learn about a new drug.

The companies want the delay to be left up to them, but critics say the F.D.A. should require a wait of up to two years. Criticism of direct-to-consumer advertising has intensified since 2004, after Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.

“From the beginning , everyone, including the company, agreed that not everybody ought to be getting Vioxx,” said Helen Darling, president of the National Business Group on Health, an organization of large employers. “But the ads implied there was a widespread need for it.”

Spending on consumer drug advertising, meanwhile, has been growing robustly, from $1.1 billion in 1997 to $4.2 billion in 2005, according to a recent report to Congress by the Government Accountability Office . In the first nine months of 2006, spending rose 8.4 percent to $3.29 billion, on track toward $4.5 billion for the year, according to TNS Media Intelligence, an advertising research firm.

Spending on the ads faltered in 2005 after soaring 27 percent in 2004, before Vioxx was withdrawn, said David Kweskin, a senior executive at the firm. “Now they are in a catch-up phase.”

Two independent government watchdog groups sharply criticized consumer drug advertising recently, and a separate survey Jan. 9 commissioned by the PricewaterhouseCoopers accounting and consulting firm indicated that skepticism is widespread among the public, too. Only 1 in 10 consumers said the direct-to-consumer, or D.T.C., ads could provide useful information to a large audience, the survey said. (Consumer drug advertising is not permitted in most of the world, except New Zealand and the United States.)

The pharmaceutical industry itself acknowledges having an image problem.

“It would be naïve to not acknowledge the fact that D.T.C. advertising is also a lightening-rod in the health care debate in this country,” said Billy Tauzin, the former congressman who is now president and chief executive of the Pharmaceutical Research and Manufacturers of America, in a speech to venture capitalists last spring. There is “one great problem” that the manufacturers face, he said: “in a word, it is trust.”

“While individual patients find the information useful in discussions with their physicians,” he added in his speech, “patients, physicians and consumers generally express unhappiness with D.T.C. advertising.”

Mr. Tauzin’s organization issued voluntary guidelines for consumer ads, which took effect last year. Under the guidelines, the companies have promised to hold off on consumer advertising of a new medicine for an unspecified “appropriate” period. That would allow time to tell doctors about risks and benefits, before television and Web site viewers see an ad and demand a prescription.

Twenty-seven members of the pharmaceutical manufacturers organization have endorsed the guidelines, but it is hard to figure exactly how long the delays in advertising will run. Bristol-Myers Squibb has said that it would delay for 12 months. Johnson & Johnson and Pfizer said they would wait six months. The manufacturers group cannot say how other companies have interpreted the guidelines, a spokesman said.

But according to TNS Media Intelligence, the companies have actually been waiting 15 months, on average, since the Vioxx debacle. Critics say that even after F.D.A. approval, the full safety profile of a new drug cannot be known until it has been widely used for a number of years.

But the manufacturers’ guidelines have to be voluntary, said Daniel E. Troy, a former chief counsel of the F.D.A., because the Supreme Court has “struck down restrictions on advertising of tobacco, alcohol, gambling and unapproved compounded drugs.”

The agency sent 15 warning letters to drug companies regarding ads in 2005 and a total of 22 complaints last year.

The F.D.A. told AstraZeneca, for example, to “immediately cease” a “misleading superiority claim” in a 2005 TV commercial. The ad said AstraZeneca’s Crestor was “clearly the best” in a “head to head” test with the three largest-selling cholesterol drugs.

Emily Y. Denney, an AstraZeneca spokeswoman, said that by the time the letter was received, in March 2005, the ads were no longer running. The company defended its message in the advertising as “appropriate.”

Another F.D.A. letter told Amgen, a biotechnology company, to stop running commercials for Enbrel, a treatment for the skin disease psoriasis, that the F.D.A. said minimized “serious risks” associated with the drug. Amgen immediately withdrew the commercial.

Last year, the company obtained F.D.A. approval of the contents of a new Enbrel television ad before showing it, David Polk, an Amgen spokesman said. Corporate lawyers say such advertising is protected by the First Amendment under a doctrine of commercial free speech. But some experts say the limits of the protection are murky.

The closest approach to clarity was in 2002 when the Supreme Court rejected, by a 5-to-4 vote, a federal restriction on advertising by pharmacists who make their own compounds.

“It is a giant game of chicken between the government and the industry,” said R. Alta Charo, a law professor and bioethics specialist at the University of Wisconsin in Madison. “I don’t believe either side really wants to see a definitive case go to the Supreme Court because neither side is willing to take the risk that they will lose.”

Professor Charo was a member of a committee of experts of the Institute of Medicine, which examined drug safety issues at the request of the F.D.A. Last fall, the committee called on Congress to give the F.D.A. new authority over advertising, including the power to require a two-year moratorium on advertising before approving a new drug.

“I think the Congress has clearly indicated its strong interest and concerns about the F.D.A. and drug safety for consumers,” said Sheila P. Burke, a longtime Republican health policy expert who headed the Institute of Medicine committee. “Broad-scale advertising can sometimes lead to a rapid increase in the use of a drug” that raises the risk of harm for patients, she said.

F.D.A. regulators would be granted the power to require moratoriums under a bill sponsored by Senators Edward M. Kennedy and Michael B. Enzi, the chairman and ranking Republican member of the Senate Health, Labor, Education and Pensions Committee.

“Patients deserve the best and most accurate information about the medicines they take,” Senator Kennedy said in a statement. “An essential part of any drug safety proposal must be to give the F.D.A. the authority and resources it needs to oversee direct-to-consumer advertising, and to allow the F.D.A. to impose conditions or limits on that advertising, where needed to protect the public health.”

Testifying for the pharmaceutical industry last year, Dr. Adrian Thomas, a vice president of Johnson & Johnson, insisted that “the important First Amendment issues that arise from banning truthful speech, even for a period of time, must be carefully considered before legislating in this area.”

The Government Accountability Office said last November that the F.D.A. should be doing a better job of overseeing consumer drug ads. Now, the F.D.A. reviews only a small fraction of the advertising, picking and choosing without proper priorities, the G.A.O. said.

The G.A.O. report had been requested by three influential senators: Bill Frist, a doctor, before he stepped down as Republican leader of the Senate; Charles E. Grassley , now the ranking Republican on the finance committee, and Herb Kohl, a Democrat who heads an appropriations subcommittee that oversees the F.D.A.

Representative Henry A. Waxman, a California Democrat who is chairman of the House Oversight and Reform Committee, added a further criticism: that the F.D.A. had been slow to crack down on drug ads that included “false and misleading” claims, he said in a telephone interview.

F.D.A. officials said they had to deal with 54,000 drug promotions each year, aimed at both doctors and consumers.

* “We are seriously considering all of the recommendations” of the Institute of Medicine report, said Thomas Abrams, director of the F.D.A.’s division of drug marketing, advertising and communications.
Copyright 2007 The New York Times Company
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Showdown Looms in Congress Over Drug Advertising on TV

Written by Able Child on January 22, 2007. Posted in Lawmaking, MedWatch.

By Milt Freudenheim, The New York Times.

Alaska Supreme Court Strikes Down Forced Psychiatric Drugging Procedures

Written by Able Child on July 1, 2006. 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.”

Calls Come For FDA ADHD Panel Member to Step Down

Written by Sheila Matthews on January 5, 2006. 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.

Third Grader Is Handcuffed, Medicated At School

Written by Able Child on November 18, 2005. Posted in Lawmaking.

School officials in Phoenix are in trouble and parents are seething after a third-grade girl was reportedly brought to school by police in handcuffs, and then forced to take pills.

“This never should have happened. This child never should have been brought into a classroom full of kids,” said one parent at a PTA meeting.

Parents at the meeting were asking some tough questions after a third grade girl arrives at school Tuesday in handcuffs.

Teachers watched in horror.

Television Adverts for Antidepressants Cause Anxiety

Written by Able Child on November 12, 2005. Posted in Lawmaking, MedWatch.

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).

A Pragmatic Approach for Troubled Kids

Written by Able Child on November 1, 2005. Posted in Lawmaking.

By Leila Abboud, The Wall Street Journal

With persistent concerns about using powerful psychiatric drugs on children, there is growing interest in counseling techniques for troubled kids that aim to change destructive behavior.

These therapies are getting a push because they have been shown in numerous clinical trials over the past decade to be effective on kids with severe behavioral problems, where other approaches have often failed. The techniques take a pragmatic approach, often using a set curriculum to teach new behaviors, rather than ferreting out the underlying emotional problem as with traditional psychotherapy. In another departure from traditional talk therapies, much of the counseling is often directed at parents.