Author: Sheila Matthews

By Nicole Gaouette
April 6, 2009

U.S. Senator Charles Grassley expanded his investigation into drug company influence on the practice of medicine by asking a nonprofit mental-health-advocacy group about its funding.

In a letter sent today to the National Alliance for Mental Illness, based in Arlington, Virginia, Grassley asked the nonprofit group to disclose any financial backing from drug companies or from foundations created by the industry. The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions. His efforts have led New York-based Pfizer Inc. to begin disclosing consulting payments to U.S. doctors, and Harvard Medical School in Boston to reexamine its conflict-of-interest policies. Now Grassley is expanding his inquiries to nonprofit groups.

“I have come to understand that money from the pharmaceutical industry shapes the practices of nonprofit organizations which purport to be independent in their viewpoints and actions,” Grassley wrote in his letter. Officials at the National Alliance for Mental Illness didn’t return calls for comment. The group identifies itself as the largest grassroots organization in the U.S. for people with mental illness and their families. The group came under scrutiny in 1999, when the magazine Mother Jones reported that 18 drug companies gave the group $11.7 million from 1996 to mid-1999. The article reported that at one point an executive of Indianapolis-based Eli Lilly & Co. worked out of the nonprofit group’s headquarters.

A 2007 annual report showed that the group’s corporate partners at that time included Madison, New Jersey-based Wyeth; London-based GlaxoSmithKline Plc; Eli Lilly, which makes Prozac; and the Washington-based trade group Pharmaceutical Research and Manufacturers of America.

Financial Report

A separate financial report shows the National Alliance for Mental Illness brought in $10.5 million in contributions in the year that ended June 30, 2007. The donors aren’t broken out.

Vera Sharav, president of the Alliance for Human Research Protection, a New York-based nonprofit that promotes ethical research, said the National Alliance for Mental Illness may have drawn Grassley’s attention because it lobbies Congress for mental-health funding.

“Academics and physicians give an appearance of authority,” Sharav said by telephone. “Industry gives them the money. Grassley has been going after each group systematically, and the dots are being connected.”

In January, Grassley and Senator Herb Kohl, a Wisconsin Democrat, reintroduced the Physician Payment Sunshine Act, which would require manufacturers to report on payments to doctors and any physician-owned facility.

Pfizer Announcement

Grassley’s investigations have led to changes in industry and academia. Pfizer made its announcement about disclosing physician payments in February. In March, the American Psychiatric Association said it would no longer accept industry support for symposiums and meals at its annual meetings.

On April 1, Stanford University School of Medicine, near Palo Alto, California, said it would post on a Web site all income faculty earned from royalty payments and outside consulting.

In the March 31 issue of the Journal of the American Medical Association, a group of researchers and physicians called for professional medical associations to transform their operations to avoid conflicts of interest posed by “extensive funding from pharmaceutical and device companies.” The group included Steven Nissen, a Cleveland Clinic cardiologist.

New York Times

By GARDINER HARRIS
Published: August 4, 2007

WASHINGTON, Aug. 3 — An influential Republican senator says he will propose legislation requiring drug makers to disclose the payments they make to doctors for services like consulting, lectures and attendance at seminars.

The lawmaker, Charles E. Grassley of Iowa, the senior Republican on the Senate Finance Committee, cited as an example the case of a prominent child psychiatrist, who he said made $180,000 over just two years from the maker of an antipsychotic drug now widely prescribed for children.

Mr. Grassley is one of several lawmakers to propose a federal registry of such payments. Minnesota, Vermont and Maine already have similar registries, and other states are considering them.

The proposals are a response to growing concerns that payments from drug makers can affect doctors’ prescribing habits, increase the cost of health care and, in some cases, endanger patients’ health.

The drug industry opposes such registries, saying they would discourage doctors from receiving needed education. John Bentivoglio, a lawyer in Washington who represents drug makers, said the registries would be a burden for the companies and might be misinterpreted.

“One of the concerns is that these payments are seen as bribes,” Mr. Bentivoglio said. “That’s not the case. The vast majority are lawful payments for services.”

In a speech on the Senate floor on Thursday, Mr. Grassley said he had started an investigation into these practices. Noting that most universities require academic researchers to disclose such payments, he said, “I have sent letters to a handful of universities to understand how well such a reporting system actually works.”

These letters have uncovered several problems, Mr. Grassley said. First, universities do not verify the information filed by their professors, so “the only person who knows if the reported income is accurate and complete is the doctor who is receiving the money.”

Also, the universities generally keep this information secret from patients, who have no way of knowing whether their doctor is on a drug maker’s payroll, he said.“So if there is a doctor getting thousands of dollars from a drug company — payments that might be affecting his or her objectivity — the only people outside the pharmaceutical industry who will probably ever know about this are the people at that very university,” he said.

Mr. Grassley said that he had asked how much the child psychiatrist, Dr. Melissa DelBello at the University of Cincinnati, made from AstraZeneca, the London-based drug giant that manufactures the antipsychotic Seroquel.

Dr. DelBello’s studies of Seroquel in children have helped to fuel the widespread pediatric use of antipsychotic medicines. Those studies were inconclusive, but she has described them as demonstrating that Seroquel is effective in some children.

Asked in a past newspaper interview how much she was paid by AstraZeneca to help market Seroquel, she had said, “Trust me, I don’t make very much.” Mr. Grassley said this week that her disclosure forms at the University of Cincinnati show she received $100,000 from AstraZeneca in 2003 and $80,000 in 2004. Dr. DelBello consults for seven other drug makers as well. She did not respond to requests for comment this week.

Richard Puff, a university spokesman, said he did not know how much Dr. DelBello made in combined payments from all eight drug makers. Asked if the institution did anything to verify its professors’ financial disclosures, he replied, “We do trust our faculty when they’re making these disclosures.”

Mr. Grassley said he would propose that drug makers make public any payments made to doctors who bill the federal Medicare and Medicaid programs, which would include nearly all doctors.

Noting that voters can easily look up the contributions made to elected officials, he asked, “Shouldn’t we hold doctors to similar standards?”

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.

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.

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.