For weeks/months we have seen Hillary Clinton in TV campaign ads claiming that her actions have always benefited the children, presumably those of the United States rather than the innocent children being slaughtered in the Middle East in wars that she has supported. Given that she has had several abortions, I am not sure how that particular choice equates to helping children. Someone told her that if she wanted to succeed in politics, she would have to seem sensitive and caring and have a child. Her actions during the Bill/Hillary administration counter her incredibly deceptive claims.

During the Clinton Administration, Congressman Richard Burr and Senator James M. Jeffords sponsored a bill that legislators passed as the FDA Regulatory Modernization Act of 1997, which Clinton signed into law on November 21, 1997; it took effect on April 1, 1999. This resulted in decreasing the time it would require for the review/approval of new drugs from 30 months to 15 months. Senators Spencer Abraham, Daniel Coats, Christopher J. Dodd, Majority Leader, William H. Frist and Chuck Hagel introduced the bill in the Senate. This law allows increased patient access to experimental drugs, meaning that people will literally become guinea pigs for big pharma.

On October 7, 1998, Dr. Michael Freidman, advocating the testing of drugs for children, testified before a house subcommittee, “Very few prescription medications approved for marketing in this country are studied, let alone approved for use, in pediatric populations.” Companies test their drugs “solely in adult populations,” which he finds “particularly troubling,” because children metabolize drugs differently, and experience different side effects/toxicities than adults. For several years, the FDA has encouraged a policy change that would allow drug testing on children so that big pharma, who they serve, could add pediatric uses on drug labels. The FDA Modernization Act of 1997, section 111, sanctions pediatric studies by drug companies and subsequent pediatric labeling. ^[1]

On March 16, 1998, the FDA published a draft of approved drugs that might benefit children in the Federal Register after obtaining feedback from the AAP, PhRMA, the NIH, the Pediatric Pharmacology Research Units Network (PPRU), the National Pharmaceutical Alliance, the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers, and the United States Pharmacopeia (USP). The FDA published the final list on May 20, 1998. On June 29, the FDA issued guidelines to the drug industry on how to qualify for pediatric exclusivity. ^[2]

Most people have never heard of the Pediatric Pharmacology Research Units Network (PPRU). Sumner J. Yaffe was in the Office of Strategic Services during WW II. Thereafter, he studied pharmacology at Harvard. In 1954, he received a Fulbright fellowship and went to London. He was the director of the National Institute of Health’s Center for Research for Mothers and Children (1980-2000). While at the NIH, he promoted a research network devoted to pediatric pharmacology and is regarded as the Father of Pediatric Clinical Pharmacology. He wrote Neonatal and Pediatric Pharmacology: Therapeutic Principles in Practice (2010). Yaffe was an aggressive advocate for the study of drugs in children.

In 1990, the Institute of Medicine sponsored the Forum on Drug Development, a seminar to address the serious issue of the lack of pediatric labeling. Yaffe was instrumental in gathering the key stakeholders, NICHD, FDA, big pharma, and academia, to address this “long-standing omission.” The IOM suggested the creation of (1) incentives to promote labeling drug studies earlier in the drug development process, and (2) a network of Pediatric Pharmacology Research Units (PPRUs), as suggested by Yaffe. He was the chair of the American Academy of Pediatrics’ (AAP) Committee on Drugs. ^[3]

In 1994, the National Institute of Child Health and Human Development (NICHD) and the NIH founded the Pediatric Pharmacology Research Units (PPRU) Network which functioned until 2010. This network was a “platform for pediatric clinical trials.” One of the more than a dozen units was at Yale University under the direction of Dr. William V. Tamborlane. ^[4]

This devious law, the FDA Modernization Act (FDAMA) allows and encourages manufacturers to use children, including infants, to test patented drugs. The government even provides financial incentives to do this testing. Three children perished after they were given a heartburn medicine made by Janssen Pharmaceuticals. ^[5]

Tipper Gore, with a B.A. in psychology, was Bill Clinton’s mental health advisor for his Health Care Task Force, the architects for the health care reform proposals. Gore said, “Why should a woman with diabetes who needs insulin have it covered by insurance, whereas a woman with manic-depressive illness who needs lithium not be covered in the same way when both diseases can be managed and controlled?” The American Psychological Association (APA), according to the Los Angeles Times, claimed that eighteen percent of Americans, including fourteen million children, suffer from a diagnosable mental disorder and that one in five Americans will “experience at least one episode of major depression during their lifetimes.” In 1993, the government claimed that “mental health treatment costs about $147 billion a year,” out of the nation’s $700 billion annual health care bill. ^[6]

On June 8, 1999, the Gores and the Clintons promoted the use of psychiatric drugs during the first White House Conference on Mental Health at Howard University in Washington, DC, chaired by Tipper Gore. ^[7] The drug-industry-financed NAMI advertised it for consumers, advocates, researchers, business and medical professionals, to discuss mental health issues that affect over 50 million Americans. In addition C-SPAN covered the event live. ^[8]

During her remarks at the conference, Hillary Clinton said, “This is an historic conference, but it is more than that; it’s a real signal to our nation that we must do whatever it takes not only to remove the stigma from mental illness, but to begin treating mental illness as the illness it is on a parity with other illnesses.” She then referred to her days at Yale, “when I was a young law student working at the Child Study Center at the Yale University and taking classes at the Med School and working at the Yale New Haven Hospital, and very interested in the intersection of mental illness and the law and in the development of children and other issues that we were only then just beginning to address.” ^[9]

She then introduced Dr. Steven E. Hyman, then the Director of the National Institute of Mental Health (NIMH), now a member of the IOM governing council, who said, “The World Bank and the World Health Organization have recognized that depression is the leading cause of disability worldwide, including the United States.” ^[10] The World Bank and the National Institute of Mental Health organized the seminar Mental Health and the Global Development Agenda: What Role for the World Bank that they held November 24-25, 2003, at the World Bank Headquarters in Washington, D.C. One of the topics of discussion for the November conference was “mental health programming for low and middle-income countries.” ^[11] Hyman, a Yale graduate, has worked to increase the psychiatric classifications in the DSM.

Clinton then said, “So how then has these scientific discoveries changed the way that we as a society deal with mental illness? If you as experts and practitioners know that we should treat mental illness as real and as treatable, as a disease of a bodily part, namely the brain, what does that mean for the kind of response that we should be looking to in society?” Hyman responded, “If I can just encapsulate them briefly, it’s that these are real illnesses of a real organ—the brain. Just like coronary artery disease is a disease of a real organ—the heart. We can make diagnoses, and these diseases are treatable… In addition, we’ve learned that these diseases should be treated just like general medical disorders.” ^[12]

Following Hyman’s remarks, Clinton said, “I’m also very pleased that in July, under your leadership, the NIMH will launch a $7.3 million landmark study to determine the nature of mental illness and treatments. This will be a study that will help us guide strategies and policies for the next century by collecting information on mental illness, including the prevalence and duration of it, as well as the types of treatments that are most commonly used. NIMH will announce the launch of two new clinical trials, investing a total of $61 million, to build effective treatments for those affected by mental illness.” ^[13]

On July 7, 1999, Hillary Clinton, the first First Lady to run for political office, officially announced that she was seeking the U.S. Senate seat for New York. The Clintons then quickly purchased a house in Chappaqua, north of New York City. During her campaign, she endorsed biological psychiatry and the use of psychiatric drugs. She probably collected a lot of campaign donations from big pharma.

In February 2000, Dr. Julie Magno Zito, associate professor of pharmacy and medicine at the University of Maryland and a group of researchers published a report in the Journal of the American Medical Association about the number of prescriptions for two to four-year old toddlers and discovered “an average threefold increase in prescriptions of stimulant drugs, especially Ritalin (1990-1995). In a nationwide study of 900,000 children, Zito found that the number of children taking the drugs had tripled between 1987 and 1996. Additionally, prescriptions for antidepressants, like Prozac, had increased. ^[14]

The FDA has not approved of Ritalin for children under the age of six and at that time the FDA had not approved of antidepressants for children of any age. Evidently, many doctors prescribed these drugs for children “off label,” a terrible practice that endangers the lives of many people. Clinical research demonstrates that stimulants cause severe adverse reactions in young children, more so than in older children. Zito’s group also reported that doctors were prescribing Clonidine, an anti-hypertension agent, as a sedative, for these small children to counter the stimulant effects of the Ritalin, which may cause fatal heart problems. ^[15] Stimulants can cause mania, paranoia, and violent feelings toward others. Researchers have experimented with Ritalin to increase the symptoms in schizophrenics, a very “unethical” practice. ^[16]

The top five ranking states in 1999 for Ritalin and amphetamine use were: New Hampshire, Vermont, Michigan, Iowa, and Delaware. The lowest ranking states for Ritalin were California and Hawaii. For amphetamines, the lowest rankings were New York and Hawaii. ^[17] Gertrude Carter, a psychologist at Bennington College in Vermont, in her practice, noted the increased number of under graduates visiting her office who had been prescribed stimulants, antidepressants, or other popular psychiatric drugs. Throughout the 1990s, Carter said, the percentage of students on psychoactive drugs rose from five percent to forty percent.

Harvard Medical School psychiatrist Joseph T. Coyle reported that doctors administer stimulants, antidepressants, or antipsychotic medication to one to 1.5 percent of all children two to four years old enrolled in these (Medicaid) programs. He said, “These disturbing prescription practices suggest a growing crisis in mental health services to children and demand more thorough investigation.” He suggested that officials were especially exposing poor children to an “escalation in drugging.” This would include a “disproportionately large numbers of children from minority groups, such as African Americans and Hispanics.” He reiterated, “Psychiatric drugs bathe the brains of children with agents that threaten the normal development of the brain.” ^[18]

Reportedly, at least half of all drugs that doctors prescribe are for off-label uses. Medicaid, the largest government program, pays for outpatient drugs. In 1997, Congress appointed DrugDex Information Service, one of three establishments, to determine which off-label uses Medicaid would include. The DrugDex System was written into the U.S. Code as a reference compendium for drug use review required under Subchapter XIX, “Grants to States for Medical Assistance Programs.” DrugDex maintains a directory of drugs/treatments, to which a pharmacy may subscribe for a very hefty annual fee. Medicare is obligated to pay for the drug if DrugDex lists its use. ^[19]

At the White House, on March 20, 2000, Hillary Clinton, in an obvious attempt at damage control as a result of Zito’s study, said, “We are not here to bash the use of these medications. They have literally been a godsend for countless adults and young people with behavioral and emotional problems.” Also present was Dr. Allan Tasman, APA president who said that medications should not be viewed as a quick fix. Gina Moran, representing Novartis, the manufacturer of Ritalin, acknowledged that the drug had not been approved for use by children younger than six but had been used “safely and effectively” by millions of older children for four decades. Novartis supported the government’s plan for a large-scale study of Ritalin’s safety and effectiveness in children under six. ^[20]

Bill Clinton appointed Dr. Steven E. Hyman as the director of the NIMH (1996-2001) and David Satcher as the Surgeon General and Jane Henney as the FDA Commissioner. On May 16, 2000, Hyman stated that the NIMH intended to conduct clinical trials at six academic medical centers around the country on preschoolers, ages 3 to 5, to determine if Ritalin is safe/effective in treating preschoolers diagnosed with ADHD. ^[21] The NIMH gave $6 million to six institutions, led by Dr. Laurence Greenhill of Columbia University, to conduct a five-stage, 40-week study on Ritalin use in preschoolers. These studies were part of the three-year Preschool ADHD Treatment Study, known as PATS, financed by the National Institute of Mental Health and overseen by the New York State Psychiatric Institute in Manhattan.

Hillary Clinton encouraged the NIMH to engage in “ethically unconscionable and scientifically unjustified research on the very young.” Without her support, the NIMH might have been justifiably reluctant to expose hundreds of 2- to 4-year-old toddlers to psychiatric drugs, which amounts to child abuse. I wonder if she would recommend this for her grandchild? The government, catering to its corporate colleagues, has no business exploiting toddlers and engaging in psychiatric drug trials, especially in as much as studies have already demonstrated the harm that comes from stimulant and antidepressant use in both young and older children. The NIMH is known to manipulate research data in favor of the drug industry and their collaborators in organized psychiatry. ^[22] 

Zito’s published study did not shock the doctors who treat ADHD but it certainly had an impact on the population. Dr. Lawrence Diller, a behavioral pediatrician and the author of two books on ADHD said, “Those of us who have been prescribing medication since the 70s had been watching this huge increase. Zito’s piece put it on the front page of every newspaper.” Hillary Clinton, appearing to be concerned demanded to know what the government was doing about it. Within a short time, the Clinton administration announced “a major initiative to reduce the use of stimulants among the very young.” However, Dr. Hyman maintained the course and went ahead with the clinical study on the preschoolers. It was, after all, just political expediency to act alarmed and concerned. ^[23]

In conjunction with the requirements of the Drug Modernization Act of 1997 and to increase their profits by opening their markets to yet another segment of society, the drug companies began testing their noxious inventions on preschoolers in 2002. Politicians reasoned that in as much as physicians prescribed many psychiatric drugs off label, then why not go ahead and test them and acquire FDA approval. That dastardly legislation was only beneficial to big pharma as it relieved them of taking the responsibility and liability of testing their drugs on children in as much as the government now legally required them to do the testing during which they would stack the odds in their favor concerning the “supposed safety and efficacy of their products.” This devious partnership between the government and the drug industry is destructive to the health of hundreds of children in the trials as well of the increased drugging of toddlers nationwide. ^[24]

[1] Implementation of the FDA Modernization Act of 1997, Statement of Michael A. Friedman, M.D., Acting Commissioner, Food and Drug Administration, Department of Health and Human Services before the House Committee on Commerce, October 7, 1998, http://www.fda.gov/NewsEvents/Testimony/ucm115096.htm, viewed 7/6/2014

[2] Implementation of the FDA Modernization Act of 1997, Statement of Michael A. Friedman, M.D., Acting Commissioner, Food and Drug Administration, Department of Health and Human Services before the House Committee on Commerce, October 7, 1998, http://www.fda.gov/NewsEvents/Testimony/ucm115096.htm, viewed 7/6/2014

[3] George Giacoia, Michael D. Reed, Sumner J. Yaffe: The Father of Pediatric Clinical Pharmacology, Journal of  Pediatric Pharmacology and Therapeutics (JPPT) ( 2011 Vol. 16 No. 3, www.jppt.org, pp. 162-166, http://www.ppag.org/attachments/wysiwyg/3/Dr_Sumner_Yaffe.pdf, viewed 9/12/2014

[4] PPRU Sites, http://www.ppru.org/sites.aspx, viewed 9/12/2014

[5] Louise Kuo Habakus, Mary Holland, Kim Mack Rosenberg (editors), Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children, Skyhorse Publishing, New York, Kindle, 2011, Locations 1905-1913

[6] Marlene Cimons, Mental Health May Be Part of Reform, Tipper Gore Says, March 11, 1993, http://articles.latimes.com/1993-03-11/news/mn-1010_1_mental-health, viewed 5/17/2014

[7] Melinda Henneberger, Gores and Clintons, Relaxed and Intent, Turn to Initiatives on Mental Illness, New York Times, June 8, 1999, http://www.nytimes.com/1999/06/08/us/gores-and-clintons-relaxed-and-intent-turn-to-initiatives-on-mental-illness.html, viewed 8/28/2014

[8] White House Conference On Mental Health: “Working For A Healthier America,” http://www.nami.org/Template.cfm?Section=eNews_Archive&template=/contentmanagement/contentdisplay.cfm&ContentID=6476, viewed 5/20/2014

[9] Office of the Press Secretary, Remarks by the First Lady (Hillary Clinton) at White House Conference on Mental Health, Blackburn Auditorium, Howard University Washington DC, June 7, 1999, http://clinton4.nara.gov/WH/EOP/First_Lady/html/generalspeeches/1999/19990607.html, viewed 8/28/2014

[10] Office of the Press Secretary, Remarks by the First Lady (Hillary Clinton) at White House Conference on Mental Health, Blackburn Auditorium, Howard University Washington DC, June 7, 1999, http://clinton4.nara.gov/WH/EOP/First_Lady/html/generalspeeches/1999/19990607.html, viewed 8/28/2014

[11] The World Bank and the National Institute of Mental Health, http://siteresources.worldbank.org/INTPH/Resources/376086-1256847692707/6526326-1287681563483/RachelMentalHealth.pdf, viewed 8/28/2014

[12] Office of the Press Secretary, Remarks by the First Lady (Hillary Clinton) at White House Conference on Mental Health, Blackburn Auditorium, Howard University Washington DC, June 7, 1999, http://clinton4.nara.gov/WH/EOP/First_Lady/html/generalspeeches/1999/19990607.html, viewed 8/28/2014

[13] Office of the Press Secretary, Remarks by the First Lady (Hillary Clinton) at White House Conference on Mental Health, Blackburn Auditorium, Howard University Washington DC, June 7, 1999, http://clinton4.nara.gov/WH/EOP/First_Lady/html/generalspeeches/1999/19990607.html, viewed 8/28/2014

[14] Erica Goode, Study Finds Jump in Children Taking Psychiatric Drugs, January 14, 2003, http://www.nytimes.com/2003/01/14/us/study-finds-jump-in-children-taking-psychiatric-drugs.html, viewed 7/11/2014

[15] Erica Goode, Study Finds Jump in Children Taking Psychiatric Drugs, January 14, 2003, http://www.nytimes.com/2003/01/14/us/study-finds-jump-in-children-taking-psychiatric-drugs.html, viewed 7/11/2014

[16] Peter R. Breggin, David Cohen, Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Drugs, Perseus, Cambridge, Massachusetts, 2000, p. 65

[17] IMS, Vector One: National (VONA) and Total Patient Tracker (TPT) Database, Statistics on Stimulant Use, http://www.pbs.org/wgbh/pages/frontline/shows/medicating/drugs/stats.html, viewed 8/28/2014

[18] Dr. Peter R. Breggin, The Psychiatric Drugging of Toddlers, Ethical Human Sciences and Services, Vol. 2, No.2, 2000, http://breggin.com/index.php?option=com_docman&task=doc_download&gid=139&Itemid=37, viewed 7/11/2014

[19] Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What to Do About It, Random House Publishing Group, New York, Kindle, 2004, Locations 2509-2515

[20] Robert Pear, Effort on Mood Drugs for Young Is Backed, The New York Times, March 21, 2000, http://www.nytimes.com/2000/03/21/us/effort-on-mood-drugs-for-young-is-backed.html, viewed 8/28/2014

[21] Steven E. Hyman, M.D. Director National Institute of Mental Health National Institutes of Health, U.S. Department of Health and Human Services, Statement for the Record on Methylphenidate (Ritalin) for Children with ADHD Before the House Education and the Workforce Subcommittee on Early Childhood, Youth, and Families, May 16, 2000, http://www.hhs.gov/asl/testify/t000516c.html, viewed 7/11/2014

[22] Dr. Peter R. Breggin, The Psychiatric Drugging of Toddlers, Ethical Human Sciences and Services, Vol. 2, No.2, 2000, http://breggin.com/index.php?option=com_docman&task=doc_download&gid=139&Itemid=37, viewed 7/11/2014

[23] Sheryl Gay Stolberg, Preschool Meds, The New York Times, November 17, 2002, http://www.nytimes.com/2002/11/17/magazine/17RITALIN.html?src=pm&pagewanted=1, viewed 8/28/2014

[24] Dr. Peter R. Breggin, The Psychiatric Drugging of Toddlers, Ethical Human Sciences and Services, Vol. 2, No.2, 2000, http://breggin.com/index.php?option=com_docman&task=doc_download&gid=139&Itemid=37, viewed 7/11/2014