July 25, 2007
AbleChild’s Co-founders Patricia Weathers and Sheila Matthews along with other parents and organizations visited with lawmakers to show our support for “The Parental Consent Act”, informed consent, and drug safety. We are pleased to say that many legislators are willing to listen to parent’s voices.
By Ed Silverman
For the past three years, the controversy over antidepressants has largely centered on exploring links between the pills and suicidal behavior, particularly in youngsters. But there has also been considerable chatter about homicidal thoughts.
Several killings around the country have prompted defense lawyers to blame an antidepressant for a killing. Most famously, this occurred in South Carolina, where 12-year-old Chris Pittman claimed Pfizer’s Zoloft prompted him to kill his grandparents. And one of the Columbine killers was prescribed Luvox.
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.
April 4, 2007
Via Electronic Transmission
Sidney Taurel
Chairman and Chief Executive Officer
Eli Lilly and Company
Lilly Corporate Center
Indianapolis , IN 46285
Dear Mr. Taurel:
As a senior member of the United States Senate and as Ranking Member of
the Committee on Finance (Committee), I have an obligation to ensure that the public’s money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs.
I am aware of several pending products liability actions regarding Zyprexa, an anti-psychotic drug manufactured by Eli Lilly and Company (Eli Lilly). Specifically, questions have been raised regarding safety information and marketing practices relating to that drug. Furthermore, I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee.
On December 20, 2006, I wrote to Dr. David Egilman, a plaintiffs’ expert, to request information and documents related to Zyprexa. Dr. Egilman did not provide any confidential Eli Lilly documents regarding Zyprexa. Instead, Dr. Egilman responded to my request by providing the Committee with a copy of a discovery order, dated December 15, 2006, instructing him to return Eli Lilly documents in his possession to Richard D. Meadow of the Lanier Law Firm. Eli Lilly had alleged that some of its confidential documents had been disseminated without the company’s authorization. Although no one affiliated with the Committee was a party to that dispute, I decided to suspend efforts to obtain the relevant documents until that dispute was resolved.
On February 14, 2007, Judge Jack Weinstein of the U.S. District Court for the Eastern District of New York issued a decision regarding the confidential Eli Lilly documents. The court enjoined several individuals from further disseminating the protected documents and ordered them to return any such documents and copies still in their possession or control. Contrary to what was reported in Judge Weinstein’s decision, the Committee’s Chief Investigative Counsel, Emilia DiSanto, did not receive any protected documents related to Zyprexa from Mr. James Gottstein or Dr. Egilman. Nor did Mr. Gottstein or Dr. Egilman provide any protected documents related to Zyprexa to other Committee staff.
As the dispute regarding the dissemination of the documents is now resolved, I believe the time is now right for the Committee to pursue its request for the documents. I am writing to request your cooperation with the Committee’s inquiry. In that regard please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available to the court-appointed Plaintiffs’ Steering Committee I and II pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig.
Thank you in advance for assisting the Committee. I would appreciate receiving the requested documents in an electronic and searchable format by no later than April 25, 2007.
Sincerely,
Charles E. Grassley
United States Senator
Ranking Member, Committee on Finance
http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=3917
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.
(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).
(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.
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
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
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.
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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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.
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.
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.”
