Ablechild - Unsung Hero in Battle Against Psychopharmaceutical Industry

Evelyn Pringle

The founders of Ablechild, Patricia Weathers and Sheila Matthews, have earned the title of “Unsung Heroes,” as both pioneers and warriors for over a decade, in the battle to protect children from the Psychopharmaceutical Industry.

Ablechild (Parents for A Label and Drug-Free Education), is a national non-profit founded in 2001, by these two mothers who each had personal experiences with being coerced by the public school system to label and drug their children for ADHD. Patty and Sheila went from being victims to become national advocates for the fundamental rights of all parents and children in the US.

Now with thousands of members, Ablechild acts as an independent advocate on behalf of parents whose children have been subjected to mental health screening and psychiatric labeling and drugging, and as a proponent for children in foster care who are improperly treated with psychotropic drugs, many times off-label, without informed consent.

Long Battle Against Coerced Drugging

Roughly eight years ago, on September 26, 2002, then Chairman the US House Government Reform Committee, Congressman Dan Burton (R-IN), held a hearing on the “Overmedication of Hyperactive Children,” prompted by a series in the New York Post.

“It's estimated that 4 to 6 million children in the United States take Ritalin every single day,” Burton said in his opening statement. He pointed out that Ritalin was a Schedule II stimulant under the Federal Controlled Substances Act, that research showed it was a more potent transport inhibitor than cocaine, and use in the US had increased over a 500% since 1990. The Schedule II category also includes drugs such as cocaine, morphine, and Oxycontin.

On one side of the issue, Burton said, they would hear from the associations of psychiatrists and an organization known as Children and Adults with Attention Deficit Hyperactivity Disorder (CHADD), and they believed 13% of the US population suffered from an attention disorder and it should be treated with medication.

At the other end of the discussion, he said, was the Citizens Commission for Human Rights (CCHR), and concerned parents, who challenged the legitimacy of calling ADHD a neurobiological disorder and raised questions about giving psychiatric drugs to children. Two of these “concerned parents” were Patty Weathers and Neil Bush, the brother of then President Bush, who was pressured by a private school in Houston to drug his son with Ritalin after he was misdiagnosed with ADHD by the school.

Unsung Hero - Patty Weathers

At the hearing, Patty testified about the ordeal she and her son, Michael, went through in a public school in New York State that began in 1997. When Michael entered first grade, the teacher told Patty his learning development was not normal and he would not be able to learn without medication.

“Near the end of first grade, the school principal took me into her office and said that unless I agreed to put Michael on medication, she would find a way to transfer him to a special education center,” Patty told the committee.

At this point, his teacher filled out an actor's profile for boys, an ADHD checklist, and sent it to his pediatrician, she said. “This checklist, along with a 15-minute evaluation by the pediatrician, led to my son being diagnosed with ADHD and put on Ritalin.”

Michael was not given a physical exam prior to the prescribing of Ritalin and no exams were conducted during appointments when refills for prescriptions were written.

“I would never have subjected my son to being labeled with a mental disorder if I had known that it was a subjective diagnosis,” Patty told the panel. “I would not have allowed my son to be administered drugs if I had been given full information about the documented side effects and the risks.”

“At no time was I offered any alternatives to my son's needs, such as tutoring or standard medical testing.” she said. “The school's one and only solution was to have my child drugged.”

Early on, Michael experienced the common side effects of Ritalin, such as sleep problems and loss of appetite, and by the third grade, Michael became withdrawn, stopped socializing with other children, and began chewing on pencils and other objects. He was then put on Dextrostat, an amphetamine, which only worsened the problems.

But instead of recognizing the drug side effects, the school psychologist then claimed Michael had either bipolar or social anxiety disorder and needed to see a psychiatrist. The psychologist gave Patty the number for a psychiatrist to call and the psychiatrist talked to her and Michael for a short time, and “again, with the aid of school reports, diagnosed him with social anxiety disorder,” she recalled.

Without telling her it was not approved for children, the psychiatrist prescribed the antidepressant, Paxil, saying it was a “wonder drug for kids.” “Those were her exact words,” Patty told the committee.

The drug cocktail caused even more horrendous side effects, until Michael’s behavior became so out of character that Patty could not even recognize her own son. “Through this whole ordeal, the school psychologist's favorite saying was that it was trial and error,” she said. “If one drug didn't work, try another.”

After watching Michael become violent, psychotic, hear voices and hallucinate, Patty stopped giving him the drugs. Not recognizing that he was going through withdrawal, the psychiatrist wanted to hospitalize Michael and try different sedatives and antipsychotics until they found “the right one,” but Patty refused to allow it.

After she became unwilling to give Michael the drugs, “the school threw him out,” she told the panel. “As a final blow, they proceeded to call Child Protective Services on my husband and I, charging us with medical neglect for refusing to drug our child,” she said.

The complaint filed by the school stated in part: “[Michael's] behavior at school is bizarre: He hears voices and appears delusional, he chews on his clothes and paper, he talks to himself and rambles when he talks.”

A month-long investigation cleared the charges and independent psychiatrists determined the bizarre behaviors were caused by the drugs and Michael did not need hospitalization. Medical testing by Dr Mary Ann Block, a Texas osteopathic physician, later showed that Michael suffered from anemia, hypoglycemia and allergies. When those conditions were treated, any attention problems disappeared.

On August 7, 2002, the “New York Post” ran a front-page article featuring Patty’s story. Within a few days, over 65 parents came forward to describe similar stories of coercion and intimidation used by school districts to strong arm them into drugging their kids.

Unsung Hero – Sheila Matthews

Connecticut mom, Sheila Matthews, turned on the TV one day and saw Patty testifying on C-Span at a hearing titled, “Behavioral Drugs in Schools,” on September 29, 2000, before the US House Subcommittee on Oversight and Investigations, Committee on Education and the Workforce.

Sheila immediately related with Patty because she was then going through what she would later call the “ADHD nightmare,” of being pressured to put her 7-year-old son on Ritalin, after he was screened and diagnosed with ADHD by a school psychologist, with claims he would “self-medicate” and end up a drug addict if she did not medicate him.

While testifying at this hearing, Patty explained that being labeled made Michael feel worse about himself and “like a freak” because he “had to be drugged to go to school.”

She also voiced her concerns for other families over the intimidation tactics used by schools to coerce parents into drugging their children. “If I didn't have family members who were willing to financially back my son and I in my son's cause, it is entirely possible that my son would have ended up in a psychiatric ward,” she told the panel.

That very day, Sheila made up her mind to expose the misleading information being given to parents about so-called mental disorders in public schools and expose the coercive tactics being used on parents who refused to label and drug their children.

She wanted to meet Patty so she contacted the Congressional office and they put her in touch with Marla Filidei, Vice President of CCHR International. Marla hooked her up with Patty, and together, they founded Ablechild.

National Spokespersons

Over the past ten years, Patty and Sheila have become national spokespersons. The normally shy, quiet Patty has made appearances on more than two dozen media programs including ABC’s Good Morning America, the Today Show on NBC, Hannity & Colmes on Fox, CNN’s Lou Dobbs, A&E’s Investigative Reports, and Montel Williams.

She has also been interviewed for stories in major newspapers including the New York Times, New York Post, USA Today, and Christian Science Monitor, as well as Time, People and Redbook magazines, and has been interviewed by Gary Null, Sean Hannity, Michael Regan, and other popular radio talk show hosts.

In February 2001, Patty received a “Human Rights Award,” from CCHR, and was recognized for standing up against the injustice of psychiatric labeling and drugging of children in public schools at the group’s annual banquet. Sheila received an award from CCHR in 2002, and was recognized for her hard work and role as national spokesperson.

Sheila has also appeared on TV numerous times including shows on CNN, NBC and Fox, and has been interviewed on many talk radio programs. Her story has also been featured in major newspapers and magazines including the Boston Globe, USA Today, Insight News, and the Hartford Courant, as well as Time Magazine and the Ladies Home Journal.

In her home state of Connecticut, Sheila worked with State Representative, Lenny Winkler (a nurse by trade), to secure passage of the first state law in the country that restricts schools from suggesting psychiatric diagnosing and drugging of any child as a condition of attending school. She testified before the Connecticut State Assembly about her own personal experience with the school trying to pressure her to put her son on Ritalin and the lack of validity of the disorders children are being labeled with.

Sheila was with the Connecticut Governor when he signed the bill into law in 2001 and told USA Today that she was thrilled “because it gives parents an awareness that there should be a clear difference between education and medication.”

“No other industry has total access to our children the way the psychiatric community does, and I think this new law is just the beginning of changes to come,” she told Kelly Patricia O’Meara, in an interview for Insight News.

“Kids should be off-limits as targets of convenience for the drug industry,” Sheila said. “I want the mental-health industry out of our schools.”

However, any victory celebration was short lived because in September 2001, a number of family orientated magazines began running the first ever ads for ADHD drugs. “It seems like every time we take a step forward, they come back and hit us harder,” Patty told Time Magazine.

After the Connecticut law was passed, Sheila continued to work with other parents on state and federal levels to pass similar bills. By 2003, seven states had passed laws against schools coercing parents to drug their children or expelling students whose parents refused to medicate them.

On a national level, both Sheila and Patty made many trips to Washington to educate lawmakers. In September 2001, Patty and CCHR’s Bruce Wiseman and Marla Filidei, briefed legislators at a national congress of the “National Foundation of Women Legislators,” and gained their unanimous approval of a model law in the “Child Medication Safety Act (CMSA),” which mandates that: “State educational agencies develop and implement policies and procedures that will prohibit school personnel from requiring a child to obtain a prescription for a controlled substance such as Ritalin as a condition of attending school or receiving services.”

In both October and November of 2001, Sheila traveled to Washington with Marla and Lawrence Smith, whose 11-year-old son died of a heart attack caused by Ritalin, to meet with key lawmakers and discuss the crisis of children being diagnosed and drugged in schools and the need for federal legislation to end it. They also worked with Congressional staff to get co-sponsors for the CMSA

In July 2002, the nationally syndicated columnist and radio show host, Armstrong Williams, featured Sheila, Patty and Lawrence Smith in a radio show on safeguarding children from being labeled and drugged in public schools.

The next month, Patty appeared on NBC’s “Today Show,” on August 8, 2002, and the same day, the “New York Post,” ran an article reporting that Patty was calling for a state wide tracking system to determine how widespread forced drugging was in schools.

On September 24, 2002, Patty was a guest on Hannity & Colmes on Fox, and was interviewed on CNN’s “Talk Back Live,” two days later. The next month, Patty and Michael were both guests on the “John Walsh Show,” on NBC. Patty was also featured in a Discovery Channel program that month with pediatrician, Dr Lawrence Diller, and psychiatrist, Dr Peter Breggin, which focused on the over-drugging of kids for ADHD.

Strongest Foe Funded by ADHD Drug Makers

In March 2003, Patty, Michael, and Sheila appeared on a Montel Williams show on promoting “A Parents Right to Choose,” along with Connecticut Rep, Lenny Winkler, Bruce Wiseman, Patricia Marks, Dr Mary Ann Block, and Vicky and Steve Dunkle, whose 10-year-old daughter died from Desipramine toxicity, after the antidepressant was prescribed for ADHD as a result of pressure from school officials to medicate the child.

The guests covered everything from the subjective diagnosis of mental disorders, with no confirming medical testing, to the many side effects of psychiatric drugs, to the fact that most children involved in school shootings were on psychiatric drugs. They warned that due to coercion in schools, parents all over the country were losing the right to choose whether their kids would take powerful drugs, including stimulants, referred to as “kiddie cocaine.” At the end of the program, Montel asked the audience to write to Congress asking for federal legislation against the coerced drugging of school children.

After the show aired, CHADD, the main front group for the stimulant makers, organized a letter writing campaign to Montel, who they said “mocked” ADHD, as part of responding to “offensive media depictions” of ADHD, they claimed in CHADD’s 2002-2003 Annual Report.

The group also published an open letter to Montel, saying no one would “dispute that unnecessarily placing a child on medication is deplorable.”

“But the greater travesty is delaying proper diagnosis and effective treatment for those who truly need it,” CHADD said. “The sad truth is that many more children with mental disorders slip unrecognized past the gatekeepers of mental health services than those who are improperly diagnosed.”

In April 2003, Ablechild issued a press release blasting CHADD for lobbying against the CMSA with claims that only a “handful” of incidents had occurred involving parents being coerced by schools to drug their children.

In lobbying to CHADD’s membership, the group’s CEO, E Clarke Ross, used the electronic newsletter, “News from CHADD,” to raise questions about whether the problem was common enough to require federal legislation and called such cases “isolated and highly publicized.” Because a number of states and school boards had passed laws or resolutions, Ross claimed the federal bill was “legislative overkill.”

However, for a May 13, 2003 investigative report on the CMSA published in “Insight Magazine,” in which Ross again referred to “a few highly publicized cases,” Kelly Patricia O’Meara interviewed Mike Stokke, deputy chief of staff to the Speaker of the House at the time, and found cases of school personnel demanding that parents drug children as a condition of staying in school were far from isolated in numbers or areas.

In case after case, Stokke told Insight, “when we started meeting some of these families who have been through this problem, such as in New York, New Jersey and Connecticut, we saw the coercive action of the state come in and say that the teacher says you have to take these drugs.”

“And if you don't it's child neglect and the child is taken away from the parents,” he said.

“Many of the parents that we talk to are people who have the means to fight back but what is troubling,” he said, “is that there are many families out there in similar situations who don't have the means to fight the system.”

In the press release, Ablechild noted that CHADD was only opposing the CMSA because its livelihood was at stake being the group was funded by stimulant makers. Complaints about the funneling of money through CHADD, to increase drug sales and the diagnosis of ADHD, were discussed at length during the September 29, 2002, hearing on the use of behavioral drugs in schools. Portions of a 1995 report on the matter, by the US Drug Enforcement Administration, were even read into the record.

“It has recently come to the attention of the DEA that Ciba-Geigy, the manufacturer of Ritalin, marketing under the brand name Ritalin, contributed $748,000 to CHADD from 1991 to '94,” the agency reported. “The DEA has concerns that the depth of the financial relationship with the manufacturer was not well known to the public, including CHADD members, that have relied upon CHADD for guidance as it pertains to the diagnosis and treatment of their children,” it wrote.

The agency was particularly concerned that most of the ADHD material prepared for public consumption by CHADD, and made available to parents, did not address the potential or actual abuse of Ritalin. Instead, it was portrayed as a benign, mild substance that's not associated with abuse or any serious side effects.

CHADD received $848,000 from Novartis in 2001, according to testimony at the hearing.

Kids Disabled for Cash

On its website, CHADD provides a link to a webpage on “Disability Benefits,” and tells parents that some kids with ADHD can be declared disabled and receive benefits including “cash payments,” under the federal Supplemental Security Income program.

“Children under age 18 who have disabilities, including some children with AD/HD, can receive SSI if they meet eligibility criteria,” CHADD says. “The SSI program can provide monthly cash payments based on family income, qualify the child for Medicaid health care services in many states, and ensure referral of a child into the system of care available under State Title V programs for Children with Special Health Care Needs.”

At the congressional hearing ten years ago, Colorado Representative, Bob Schaffer, reported concerns about Federal cash incentives to label children with ADHD, and specifically the two that resulted in cash payments to parents and schools.

In 1990, the SSI program made low-income parents eligible for a cash benefit of more than $450 a month for each ADHD child, and in 1991, the Department of Education made it so schools could receive more than $400 a year for students with ADHD, under the Individuals With Disabilities Education Act (IDEA).

Both cash incentives coincided with a dramatic rise in the number of children labeled with ADHD. In 1989, children citing mental impairments, including ADHD but not retardation, made up only 5% of disabled kids on SSI. But that figure rose to nearly 25% by 1995. Between 1990 and 1992, the number of ADHD diagnoses jumped from about one million to over three million, Schaffer informed the committee.

The IDEA also had a “child find” provision which required states to actively seek out kids who may qualify for special education in order to receive Federal special education funds, Patti Johnson, a member of the Colorado State Board of Education, told the panel. In many states, schools had also become authorized Medicaid providers and collected funds for children labeled with one of the learning or behavior disorders, she reported.

“Between SSI, Medicaid and IDEA, we have turned schools into aggressive identifiers of disabled children,” Schaffer told the panel. “Without a doubt we are subsidizing the aggressive pursuit of children with disabilities.”

“It is not resulting in accurate diagnosis,” he said. “It is resulting in an over diagnosis.”

Roughly a decade after the hearing, the new book, “Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America,” by Robert Whitaker, reports that the number of kids receiving SSI checks due to mental illness increased 35-fold between 1987 and 2007, from 16,200 to 561,569.

Drug Money Pours In

Despite non-stop criticism over being in the pocket of the pharmaceutical industry, money from ADHD drug makers continues to pour into CHADD year after year.

The group’s Income & Expense Reports, show CHADD received $507,000 in 2002, $674,000 in 2003, and five years later, the amounts nearly tripled. For the fiscal year of July 1, 2007 to June 30, 2008, CHADD received a total of $1,205,000, from Eli Lilly, J&J's McNeil division, Novartis, Shire US, and UCB. In addition, 64% of sales and advertising, or $466,104, came from drug companies.

The next year’s report shows CHADD received a total of $1,174,626, from Lilly, J&J's McNeil division, Novartis, and Shire, and 57.2 % of sales and advertising, or $412,500, was from drug companies.

For the year 2008, Lilly's full year grant report lists a $200,000 donation to CHADD. The 2008 IRS filing for the Eli Lilly Foundation also shows a $50,000 gift, a drop from the $100,000 given to CHADD in 2007. Lilly's 2009 grant report lists a $130,000 donation and the first quarter report for 2010 shows a $50,000 grant for CHADD. Lilly is the only ADHD drug maker required to post grant reports online, so there is no way to break down how much money is pouring into CHADD from the other companies.

The group’s 2008 IRS filing lists CHADD’s most significant activity as, “provides support for individuals with Attention Deficit/Hyperactivity Disorders.” Yet the non-profit blew $330,000 on its annual conference and another $114,950 on a 20th Anniversary Gala that same year, according to the 2008 I&E report.

Also, in sharp contrast to the yearly SSI income of about $8,000 for persons disabled by ADHD, the group’s 2008-2009 tax forms lists compensation for CEO Ross as $187,747, and the next two highest paid officials of this “non-profit” earn $130,217 and $121,095.

Landslide Vote

On May 21, 2003, the CMSA passed by a landslide vote of 425-1 in the House. On May 27, 2003, Sheila and Patty appeared on the national radio show “Scams and Scandals,” for a program about the need for the Act to end the abuse of parents by schools. During the show, they asked all parents who had experienced abuse similar to theirs to go online and sign Ablechild’s petition.

The next month, Sheila was featured in her hometown newspaper, “The New Canaan Advertiser,” in a front-page article on June 5, 2003 with the headline: “Mother pushing Congress to prevent schools from ADD testing,” with details of her campaign to enact federal legislation. The article profiled AbleChild, and criticized CHADD for its industry funding and opposition to the CMSA.

When public health officials in the UK and US announced that Paxil increased the risk of suicide in children in June 2003, Sheila pushed her Governor’s office to issue a press release warning against the use of Paxil with kids. In July 2003, the Associated Press reported that the Department of Children and Family Services in Connecticut planned to stop using Paxil to treat young people with depression.

The “New American,” published an article titled, “Drugging Our Kids,” by William Norman Gregg in August 2003, and covered Patty and Michael’s story in depth, along with similar cases reported by other parents including Neil Bush and two families in which children died as a result of coerced drugging.

On February 20, 2004, Patty spoke on the nationally syndicated Joyce Riley radio show, and discussed the need for the CMSA in the wake of recent FDA hearings on the link between antidepressants and suicide, including Paxil, the drug Michael was prescribed.

Patty and Michael were both on CNN’s Lou Dobbs on April 15, 2004. Patty noted the need for the CMSA, evidenced by nearly 1,000 signatures on Ablechild’s website from parents with similar stories. Michael described how bad it felt to be on medications and Patty warned about the lack of informed consent given to parents regarding both the diagnoses of mental disorders and the drugs used as treatment.

The next month, Patty led a protest of hundreds of parents, children and human rights activists at the opening of the American Psychiatric Association's annual conference in New York City, saying parents were fed up with psychiatrists telling them their children's behavior was a “mental disorder” requiring dangerous drugs.

Sheila was again featured in her hometown newspaper on May 10, 2004, in an article about the need for an investigation by the Connecticut Attorney General into the drugging of children in foster care. Sheila was quoted throughout and promoted passage of CMSA.

Another federal bill that was introduced as a “Prohibition on Mandatory Medication,” amendment to the IDEA in April 2003, was passed by the House and Senate on May 13, 2004, and banned state and local educational agency personnel from requiring a child to take a drug covered by the Controlled Substance Act as a condition of attending school, receiving an evaluation, or receiving services. Key wording from the CMSA was included in the amendment.

On September 13, 2004, Patty testified at an FDA advisory panel hearing on the need for black box warnings on antidepressants about the risk of suicide and violence. “The FDA had enough evidence 14 years ago to issue these warning labels,” she told the committee.

She also testified about the lack of science behind psychiatric labels given to children. “Parents are told that their child has a chemical imbalance or a neurobiological illness,” she testified. “We risked our child's life based on this fundamental lie.”

“The FDA is well aware that there are no x-rays, biopsies, blood tests or brain scans that verify these mental disorders as a disease or illness,” she said. “The FDA should not be condoning or approving these drugs without evidence of disease, illness or physical abnormality that would justify risking our children's lives with a harmful and potentially lethal drug.”

The hearing ended with a vote by the panel in favor of black box warnings.

In November 2004, Patty was interviewed by a French TV producer for a news program in France, similar to 60 Minutes, focused on the pressuring of parents by schools in American to put children on psychiatric drugs. Other guests included Vicky Dunkel and Tom Woodward, whose daughter committed suicide after being prescribed an SSRI.

On February 17, 2005, Patty testified at a hearing titled, “ADHD Diagnosis, Treatment & Consequences,” in New York City, and told the story of what happened when Michael was labeled mentally ill in a public school and she refused to keep drugging him.

“The irony of the whole ordeal was that I was charged with medically neglecting my son, when there was no proof that anything was medically wrong with him,” she testified.

The next month, the “Ladies Home Journal,” ran an article titled, “A Generation out of Control,” with a sub-heading that read: “A record four million children -- some as young as 2 -- are being diagnosed with ADHD and many are being put on powerful medications, perhaps for life.”

The article featured Sheila, and Patricia Marks, another Connecticut mom whose son was misdiagnosed with ADHD. The article discussed the dangers of teachers diagnosing kids in schools to solve classroom problems and warned parents to make sure and rule out undiagnosed medical conditions that might manifest as ADHD.

Also in March, in letters to the US Attorney for the District of Minnesota and the FDA, Ablechild called for an investigation into the role of antidepressants in a school shooting by Jeff Weise in Red Lake, Minnesota, who was on Prozac when he went on a rampage, killing his grandfather first, and then fellow students and teachers at his school, before committing suicide with the same gun.

In a press release, Ablechild expressed outrage and frustration with the FDA for “continuing to turn a blind eye to the all so obvious link to violence and mania that these drugs are having on our youth, and even more, their deadly link to uncontrolled school terror that has occurred from coast to coast.”

In October 2005, Sheila issued a statement from Ablechild strongly opposing TeenScreen, a program aimed at screening kids for mental illness in schools. “TeenScreen is nothing more than the bio-behavioral health industry's attempt to garnish big government funding for useless programs that profitably promote a course of recommended psychotropic drug “treatment” which has been clearly liked to suicide and violent behavior,” she warned.

In October 2006, Sheila appeared on “The Big Story,” with John Gibson on Fox, in a segment titled “Investigating the Link: Antidepressants & Violence,” based on recent school shootings in Pennsylvania and Colorado, and spoke of the need to investigate the correlation between psychiatric drugs and school shooters, and toxicology tests to determine whether shooters were on drugs. As the founders of Ablechild, parents came to them all the time, Sheila said. “Their children are committing suicide on these drugs and we’re very concerned.”

At the end of the show, the reporter noted particular concern about the fact that 30 million Americans were taking antidepressants, and being that 5% would develop mania, there could be “a million and a half potential maniacs waiting to explode.”

Focus On Drug Side Effects

Over the years, Ablechild has also focused on educating the pubic on drug side effects and MedWatch, the FDA’s adverse drug reaction reporting system. On December 13, 2006, Sheila testified at the FDA advisory hearing on the risk of suicide with adults on SSRIs and presented the results of two surveys showing a lack of public knowledge about Medwatch, and asked the FDA to initiate campaigns to let consumers know where and how to report ADRs, as consumers detect adverse effects sooner than providers.

In June 2007, Shelia, along with two CCHR representatives, met with Washington lawmakers regarding the renewal of the “Prescription Drug User Fee Act.” The new Act was signed into law in September 2007, with key measures to help increase public knowledge about prescription drug risks, as well as better safety monitoring by the FDA.

On November 6, 2007, Ablechild issued a news alert to warn that despite the black box warnings, the mental health industry was continuing to downplay the suicide risk of antidepressants. Based on information posted within the MedWatch system, “an estimated 63,000 suicides have been committed by people under the influence of antidepressants,” the alert reported.

It also noted that most parents were not aware that at least eight school shooters “were under the influence of antidepressants documented to cause not only suicidal ideation but also mania, psychosis, hostility, hallucinations and even ‘homicidal behavior.’”

With 1.5 million children on antidepressants in the US alone, “Ablechild is deeply concerned about the number of children being prescribed the powerful and potentially lethal drugs,” the alert stated.

In December 2007, Sheila called into a National Public Radio program, when the topic was the recently passed FDA reform bill, and discussed a new requirement that all print ads include an 800 number and information on reporting side effects to MedWatch. She also noted the importance of the new clinical drug trial registry that would be available on the internet, and the elimination of conflicts of interest on FDA advisory committees.

Protect Youngest Victims

In 2008, Ablechild teamed up with Amy Philo’s “Unite for Life” coalition of advocacy groups in efforts to protect unborn children and nursing infants from forced drugging through their mothers’ ingestion of drugs, by lobbying against a bill called the “Mothers Act,” for short, aimed at screening pregnant women and new mothers for mental illness.

The Act “quite simply is a feeder line for the psycho-pharmaceutical industry and will result in more mothers and infants being put at risk for being prescribed antidepressants and other dangerous psychiatric drugs,” AbleChild warned in a letter made available on its website for persons to sign and send to members of Congress.

In April 2008, Patty, Amy Philo, Marla Fidili from CCHR, Mathy Downing, whose 12-year-old daughter committed suicide after being given Zoloft off-label for test anxiety, and about 40 more advocacy allies, went to Washington to lobby against the Mother's Act.

The latest evidence of infants being harmed by psychiatric drugs ingested by their mothers was reported on July 2, 2010, with a Medscape Today headline, “Psychotropic Medications Linked to Serious Adverse Drug Reactions in Children,” for a study by Danish researchers of 4,500 adverse drug reactions (ADRs), in children younger than 17, listed in the national Danish ADR database between 1998 and 2007.

The results showed 429 reports were from psychotropic drugs, with the largest share from stimulants at 42%, followed by antidepressants with 31%, and antipsychotics at 24.5%.

Almost 19%, or 80 of the ADRs, were for children between the age of birth and 2. All but one was serious, with two deaths associated with the SSRIs Celexa and Prozac. These findings were “probably due to the mothers' intake of psychotropic medicine, primarily antidepressants and antipsychotics, during pregnancy,” the study authors wrote.

Sheila and Patty, along with Amy Philo, Mathy Downing, and Vicky Dunkle, received an “Outstanding Achievement Award for Children’s Rights,” in February 2009, at CCHR’s annual banquet, highlighted by a video tribute featuring much of their work.

In April 2009, Sheila drafted a petition in support of the “Parental Consent Act,” and made it available on Ablechild’s website for persons to sign and send to members of Congress. Introduced by Texas Congressman and physician, Ron Paul, the bill prohibits federal funds from being used to establish or implement any universal or mandatory mental health screening program for public school students and establishes a parent's right to refuse screening of a child without fear of being charged with child abuse or neglect. In an April 30, 2009 speech, Paul pointed out that “parents are already being threatened with child abuse charges if they resist efforts to drug their children.”

“Imagine how much easier it will be to drug children against their parents' wishes if a federally-funded mental-health screener makes the recommendation,” he said.

Million Kids Misdiagnosed With ADHD

After a decade of work by Sheila and Patty to expose the fraud behind labeling kids with ADHD, on August 17, 2010, USA Today reported that a new study from Michigan State University found nearly 1 million children may have been misdiagnosed with ADHD, not because of any real behavioral problems, but because they were the youngest in the class.

Children who are the youngest in their grades are 60% more likely to be diagnosed with ADHD than the oldest kids, according to the study published in the Journal of Health Economics. In fifth and eighth grade, the youngest children were more than two times as likely to be on Ritalin compared with the oldest students, the study found.

(This article is the first in an on-going series honoring the many “Unsung Heroes” in the two decade battle against the drugging of children by the Psychopharmaceutical industrial Complex).

World Experts Demand End to Child Drugging in the US - Part I

Evelyn Pringle October 25, 2007

On October 12, 2007, experts in the field of psychiatry and child development from all over the world arrived in Washington to attend the annual conference of the International Center for the Study of Psychiatry and Psychology. This year's conference focused on one specific goal - to end the mass-prescribing of psychiatric drugs to children.

In addition to the seminars and presentations by psychiatric experts and academics, other presenters and speakers at the conference varied from patients and leaders of patient advocacy groups to social workers, nurses, educators, authors and lawmakers.

The conference included presentations on the serious health risks associated with the new generation of psychiatric drugs now commonly prescribed to children, including attention deficit medications, antidepressant drugs and atypical antipsychotics.

Much of the outrage expressed by speakers and attendees alike stemmed from the recommendation by the Bush Administration's New Freedom Commission on Mental Health to conduct "universal" mental illness screening of all Americans from the age of "0" on up to the oldest living citizen.

The main topics of debate included the recommendations by the NFC to screen public school children in all 50 states with a program called TeenScreen and the implementation in many states of programs modeled after TMAP (Texas Medication Algorithm Project), a treatment plan that mandates the use of the new expensive psychiatric drugs with all patients diagnosed with mental disorders who are covered by public health care programs such as Medicaid.

The new generation of antidepressant drugs include Prozac and Cymbalta by Eli Lilly; Paxil marketed by GlaxoSmithKline; Zoloft by Pfizer; Celexa and Lexapro from Forest Laboratories; Effexor by Wyeth, as well as generic versions sold by Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

The new generation of atypical antipsychotics include Zyprexa by Eli Lilly; Risperdal marketed by Janssen Pharmaceuticals, a subdivision of Johnson & Johnson; Abilify by Bristol-Myers Squibb; Clozaril sold by Novartis, and Geodon by Pfizer.

Many of the presentations at the conference focused on the pharmaceutical industry's role in the invention of both TMAP and TeenScreen and the many financial ties between the drug makers, the Bush administration, a group of psychiatrists, and state policy makers largely credited with the creation and promotion of these two programs.

Minnesota Pediatrician Dr Karen Effrem produced a briefing booklet and CD entitled, "The Dangers of Universal Mental Health Screening," which is available at the ICSPP web site at http://www.icspp.org/.

During her presentation, Dr Effrem explained the history of TMAP and TeenScreen, a 52-question computerized self-administered questionnaire that takes 10 minutes to complete and was developed by Columbia University Children's Psychiatric Center.

"The New Freedom Commission, TMAP and TeenScreen," Dr Effrem notes, "appear to be a blatant political/pharmaceutical company alliances that promote medication, and more precisely, more expensive antidepressants and antipsychotics, which are at best of questionable benefit and come with deadly side effects."

During the portion on TeenSceen, Dr Effrem cited one study which found an 82% false-positive rate in students screened, meaning that if 100 students were tested, 82 were wrongly flagged as having some mental disorder. "TeenScreen's extremely high false-positive rate makes the test virtually useless as a diagnostic instrument," she stated.

According to Dr Effrem, it is "difficult, if not impossible" to diagnose young children accurately, due to very rapid developmental changes. "Often, adult signs and symptoms of mental disorders in adults are characteristics of normal development in children and adolescents," she explains.

Since the arrival of selective serotonin reuptake inhibitors antidepressants (SSRI's) and atypical antipsychotics on the market, countless studies have shown the so-called "wonder drugs" to be ineffective and harmful to children. But for years, drug companies have manipulated data, suppressed negative clinical trials and published only the studies that showed positive results.

The truth is that the mass drugging of the entire population in the US with SSRI's has accomplished nothing when it comes to reducing suicidality. According to a June 2005 study, primarily funded by the National Institute of Mental Health, in the Journal of the American Medical Association, although people who were likely to attempt suicide were far more likely to be treated with antidepressants in 2001-2003, the rates for suicide attempts, gestures and ideation remained basically unchanged for over a decade.

To reach their conclusions, the researchers analyzed a survey of close to 10,000 adults and compared it to a similar survey conduced 10 years earlier for the years 1990-1992.

The prescribing rates for psychiatric drugs increased every year during that time period. On January 13, 2005, WebMD reported a government study that reviewed the patterns of treatment from the mid-1990's to 2001, and found more Americans than ever were being treated for depression, substance abuse and mental disorders but that the treatment was most often limited to drugs alone.

The cost of mental health drugs rose 20% each year, and according to study, about 80% of the increase could be explained by the increased prescribing of antidepressants and atypical antipsychotics.

A "Myth and Fact Sheet" presented at the conference reports that, in 2003, more money was spent on psychiatric drugs for children than on antibiotics and asthma medications.

By tugging at the heartstrings of parents in claiming TeenScreen is a suicide prevention tool, the drug profiteers have managed to set up the bogus screening program in towns and cities all across America, and the promoters never seem to tire of using the line that suicide is the third leading cause of death in teens and adolescents in the US. However, experts explain that the rate of suicide remains high on the list only because persons in this age group seldom die of any causes.

During his presentation at the conference, neurologist Dr Fred Baughman, a recognized authority on psychotropic drugs and author of "The ADHD Fraud," stated: "Psychiatry and the pharmaceutical industry married and launched the joint market strategy of calling all emotional and behavioral problems 'brain diseases', due to 'chemical imbalances', needing 'chemical balancers' - pills."

"Every time parents are lead to believe that their child's emotional or behavioral problems are a 'disease' due to an abnormality in the brain," Dr Baughman says, "they are lied to."

He discussed the overdose death of 4-year-old Rebecca Riley in December 2006, who was diagnosed with ADHD and Bipolar Disorder when she was only 2-and-a half-years old. She was kept on a cocktail of 3 psychiatric drugs, none of which were FDA approved alone for a child her age, much less together, until the time of her death.

The title of his presentation was, "Who Killed Rebecca Riley," and Dr Baughman placed the blame squarely on the gang of industry shills who are largely credited with the invention and promotion of ADHD and Bipolar Disorders in small children, including among others, Dr Joseph Biederman, Dr Steven Hyman, Dr Jerome Groopman and Dr David Shaffer, the brainchild credited with inventing TeenScreen.

The Fact Sheet reports a 2006 review of the FDA's MedWatch adverse event database, which found 45 deaths in children due to toxicity of antipsychotics.

Dr Baughman calls the use of the "chemical imbalance theory," the "biggest health care fraud" and "mass character assassination" in human history, and says it must be abolished.
Dr Dominick Riccio, executive director of the ICSPP, also weighed in on the "chemical imbalance" theory and said that child drugging in the US is based on a "hypotheses with no validity," propagandized by the pharmaceutical industry.

He warned that there is absolutely no scientific evidence to validate the "chemical imbalance" used to justify the drugging of America's "most precious commodity," and "if we continue to damage our children, there will be hell to pay down the line."

Dr Riccio called for "integrity" in the psychiatric profession and told professionals in attendance, "if you do not understand child development, you should not work with children."

Washington psychiatrist, Dr Joseph Tarantolo, warned that the new selective serotonin reuptake inhibitor antidepressants are not "selective," "the drugs are cannons," he said.
He also explained that the "so-called" antipsychotic drugs do not affect psychosis, "they deaden a person's response to life."

According to Dr Tarantolo, because the drugging began 10 or 15 years ago, "we are going to have an epidemic of young adults with yet-to-be-determined neurological problems due to the long term use of psychotropic drugs."

He says an epidemic is defined as 1% of the population and warns that there will be far more than 1% injured by these drugs.

The bribing of prescribing doctors in the field of psychiatry is rampant. A June 26, 2007, report by the Attorney General of Vermont of payments made to doctors by drug companies during the period July 1, 2005 through June 30, 2006, shows that, by category, psychiatrists were the largest beneficiaries, and 11 psychiatrists received a combined total of $502,612.02, or more than 22% of the overall total of all payments.

For the past 4 years, psychiatric drug makers have remained high on the list of the top 10 spenders in Vermont, with Paxil maker Glaxo holding the number one position in both 2003 and 2004.

An analysis of Minnesota disclosure records by the consumer watchdog group Public Citizen, reported by the Pioneer Press, found a similar windfall for shrinks in that state between 2002 and 2006, with psychiatrists receiving combined payments of $7.38 million.

However, the drug maker's off-label sales of antipsychotics are now under fire due to the greed involved in the billings submitted for Medicaid patients. In September 2007, Arkansas became the latest state to sue the drug makers when it announced the filing of a lawsuit against Lilly, Janssen and AstraZeneca for "improper and unlawful marketing," of their drugs and concealing the serious health risks associated with their use.

The Medicaid fraud lawsuits seek to recover not only the money paid for the antipsychotics but also the cost of medical care for all the patients who were injured by the drugs known to cause drastic weight gain, abnormal blood sugars and diabetes.

The bribing of shrinks may be coming to an end as well because, in addition to Medicaid fraud lawsuits, states are also going after the prescribers. On August 16, 2006, the Houston Chronicle reported that five doctors in Texas were notified that they needed to return the Medicaid money paid for drugs they prescribed as part of a two-year effort to better regulate how children are prescribed psychiatric drugs in that state.

The Chronicle reported that a review of a two-month period of Medicaid records in 2004 determined that over 63,000 foster children were on stimulants, antipsychotics or antidepressants, with nearly one-third of the kids taking drugs from more than one of the three classes at the same time and that doctors had filed 114,315 claims worth over $17 million.

The experts at the ICSPP conference reported that the over-prescribing of attention deficit drugs is also out of control, even after the new warnings were issued. The ICSPP Fact Sheet notes that the new labeling changes for ADHD medications include: "Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems."

"Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional can be caused by stimulants at usual doses," the warning also notes.

Psychiatrist Dr Grace Jackson, author of "Rethinking Psychiatric Drugs," says the fact that cardiovascular risks are associated with ADHD drugs is not news. "As early as 1977," she says, "research documented the cell changes associated with heart muscle enlargement in a chronic consumer of Ritalin."

"The connection between stimulants, cardiovascular disability, and death has long been documented in the medical literature," she states.

However, no slow down in prescribing rates for these drugs is likely. In 2005, according to a December 15, 2006, report by Research and Markets, the value of the ADHD market was $2.6 billion, and it is now the 9th largest segment of the CNS market with growth of 8% year-on-year. Approximately 90% of global sales were derived from the US in 2005, and by 2012, global sales are forecast to reach $4.3 billion.

In February 2007, the FDA finally directed the drug makers to develop Patient Medication Guides to inform patients about the adverse effects of Adderall, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Metadate CD, Methylin, Ritalin and Strattera.

However, experts say children are being damaged by ADHD drugs in ways that will never show up in a pamphlet. According to child psychiatrist Dr Stefan Kruszewski, "children who are medicated early do not learn to develop coping strategies that work as they move through different developmental stages."

"We are encouraging a generation of youngsters to grow up relying on psychiatric drugs rather than on themselves and other human resources," says Dr Peter Breggin, ICSPP founder and author of, "Talking Back to Ritalin."

"In the long run, we are giving our children a very bad lesson," he warns, "that drugs are the answer to emotional problems."

"The problem with the diagnostic assessment of ADHD," Dr Kruszewski explains, "is that the prescreening statement is so inclusive that virtually every child meets prescreening criteria and therefore every child, under prevailing treatment modalities, becomes eligible for 'chronic' medication therapies."

He also points out that, once children are screened, "they become 'eligible' for additional screening for conditions such as social anxiety, bipolar disorder, and obsessive-compulsive disorder, and too often end up on even more drugs."

Dr David Stein, author of, "Unraveling the ADD/ADHD Fiasco," also warns that stimulant drugs are "near the top of the heap of potentially addictive drugs."

He says there is no way of pinpointing which children are at risk of becoming addicted, and "psychiatry has an extremely poor track record for treating addiction problems."

World Experts Demand End to Child Drugging in the US - Part II

Evelyn Pringle October 27, 2007

Mathy Milling Downing was a featured speaker at the annual conference of the International Center for the Study of Psychiatry and Psychology and told the audience that her anger is directed toward the FDA and drug companies, "for their incompetence and lack of concern for innocent children they have helped to kill, my little girl included."

Her 12-year-old daughter, Candace, hung herself from the valence of her bed on January 10, 2004, after being prescribed the antidepressant drug Zoloft for "test anxiety" at school.

Experts in the field of psychiatry and child development from all over the world attended this year's annual conference in Washington with the agenda aimed at ending the mental health screening programs put in place by the Bush Administration's New Freedom Commission and the mass-drugging of children with psychiatric drugs.

During her presentation, Ms Downing said she objected to placing Candace on drugs but was assured that Zoloft was safe and did not learn until after her daughter's death that "up to four children out of every hundred run a risk of dying by their own hand or at least attempt to."

Had she been given the opportunity to have informed consent on the dangers of SSRI's, she said, "my child would still be alive."

"I never would have allowed my child to be placed on a drug with no proven efficacy and a history of possible harm," Ms Downing stated.

She described how she tried to contact doctors at the FDA numerous times to express her concerns, and no one was ever available to speak to her. She filed a complaint with MedWatch on March 18, 2004, and, "I am still waiting for my reply," she stated.

"One would think that the FDA would support the needs of Americans over the greed of the various pharmaceutical corporations," she said, "but that continues to be a pipe dream of mine rather than a reality."

Critics say TeenScreen, billed as a suicide prevention tool, is nothing more than a drug marketing scheme developed by the pharmaceutical industry and a front group operating under cover of Columbia University to establish a customer base within the nation's 50-odd million school children for the new generation of psychiatric drugs, including selective serotonin reuptake inhibitor antidepressants (SSRI's) and atypical antipsychotics.

These so-called new "wonder drugs" include the antidepressants Prozac and Cymbalta by Eli Lilly; Paxil from GlaxoSmithKline; Zoloft by Pfizer; Celexa and Lexapro from Forest Labs; Effexor by Wyeth, as well as generic versions of the drugs. The atypical antipsychotics include Zyprexa by Lilly; Risperdal, marketed by Janssen Pharmaceuticals; Abilify by Bristol-Myers Squibb; Clozaril by Novartis, and Geodon by Pfizer.

Best-selling author of "Mad in America", Robert Whitaker, tracked the profits of these "wonder drugs" since the first SSRI, Prozac, arrived on the market in 1987 and found a tremendous rise in the cost to taxpayers. In 1987, psychotropic medication expenditures were about $1 billion, but by 2004, in a 40-fold increase, the cost had risen to $23 billion.

According to Mr Whitaker's analysis, global sales of antipsychotics went from $263 million in 1986 to $8.6 billion in 2004, and antidepressant sales rose from $240 million in 1986 to $11.2 billion in 2004.

In the paper, "Psychiatric Drugs and the Astonishing Rise of Mental Illness in America," published in the Spring 2005 issue of the Journal of Ethical Human Psychology and Psychiatry, Mr Whitaker also reports that, in addition to breaking sales records, within 10 years on the market, "Prozac quickly took up the top position as America's most complained about drug." He further states:

"By 1997, 39,000 adverse-event reports about it had been sent to MedWatch. These reports are thought to represent only 1% of the actual number of such events, suggesting that nearly 4 million people in the US had suffered such problems, which included mania, psychotic depression, nervousness, anxiety, agitation, hostility, hallucinations, memory loss, tremors, impotence, convulsions, insomnia and nausea."

According to the paper, "It is well-known that all of the major classes of psychiatric drugs - anti-psychotics, anti-depressants, benzodiazepines, and stimulants for ADHD - can trigger new and more severe psychiatric symptoms in a significant percentage of patients."

Ms Downing has been on a non-stop crusade to prevent the death of more children since her daughter died and the family's tragedy is featured in the documentary, "Prescription: Suicide," which also includes the story of 6 families effected by their encounters with SSRIs and how their lives changed forever. A copy of the film is available on the Participate Now web site at www.participatenow.net.

Candace should never have been given Zoloft because it was never approved for use with kids. Prozac is the only SSRI approved for children in the US because it is the only drug reportedly shown to be effective in two pediatric clinical trials, a requirement that must be met to obtain FDA approval.

But according to ICSPP founder and leading SSRI authority Dr Peter Breggin, the term "effective" has little meaning because all a drug company has to do is show better results in kids treated with an SSRI than in children taking a placebo and can conduct 100 trials if need be to get the two positive studies. It stands to reason that with 50-50 odds, if enough trials are conducted, an SSRI is bound to do better than a placebo eventually.

However, with that in mind, experts say it's important to note that, other than Prozac, the SSRI makers have not been able to provide the FDA with 2 positive studies out of all the clinical trials that have been conducted in hopes of obtaining FDA approval for the sale of SSRI's to kids.

That said, SSRI makers have made a fortune by getting doctors to prescribe the drugs for unapproved uses. A University of Georgia study in the June 2006 Journal of Clinical Psychiatry found that 75% of persons prescribed antidepressants received them off-label. The researchers reviewed records of more than 106,000 Medicaid recipients in 2001 to examine the rates of off-label prescribing of drugs that act on the central nervous system and found 75% of antidepressant patients received the drugs for unapproved uses.

"More than two-thirds of the studies of antidepressants given to children showed that the medications were no more effective than a placebo, and most of the positive results came from drug company sponsored trials," Dr Karen Effrem reported in her presentation at the ICSPP conference.

Litigation against drug companies has established this fact. In 2004, New York State Attorney General Eliot Spitzer brought fraud charges against Glaxo for hiding studies that "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo." Two months later, Glaxo agreed to pay $2.5 million to settle the charges.

Mr Spitzer pointed out that Paxil was never approved to treat any condition in children, and yet doctors prescribed the drug to kids two million times in 2002, the same year that Paxil became Glaxo's top seller with $3.8 billion in sales.

On November 1, 2006, the Associated Press reported that Glaxo "has agreed to pay $63.8 million to settle a lawsuit's claims that it promoted its antidepressant drug Paxil for use by children and adolescents while withholding negative information about the medication's safety and effectiveness."

Critics say it's not difficult to track the industry money involved in the promotion of TeenScreen. The program's Executive Director, Laurie Flynn, was the Executive Director of National Alliance for the Mentally Ill (NAMI) for 16 years, which bills itself as a patient advocacy group, but in reality is the most heavily industry-funded front group in the US.

Mother Jones Magazine obtained NAMI documents for the period between 1996 and mid-1999, while Ms Flynn was running the show, which revealed that NAMI received a total of $11.72 million during that 3-year period from 18 drug companies, including Janssen, $2.08 million; Novartis, $1.87 million; Pfizer, $1.3 million; Abbott Laboratories, over $1.24 million; Wyeth-Ayerst, $658,000, and Bristol-Myers Squibb, $613,505.

NAMI's top donor during that period was none other than Lilly, the maker of Prozac and Zyprexa, which coughed up a total of $2.87 million out of the goodness of its heart.

Ms Flynn also wrote an article promoting TeenScreen entitled, "Before Their Time: Preventing Teen Suicide," in which she stated: "The TeenScreen Program developed 10 years ago by Columbia University and offered in partnership with the National Alliance for the Mentally Ill helps communities across the nation identify teens with mental illness who might be at risk for suicide."

If TeenScreen is "offered in partnership" with NAMI, critics say, it goes without saying that millions of dollars of drug company money was invested in the program.

The efforts to implement TeenScreen by use of "this partnership" cannot be understated. A video-taped presentation at the annual convention of NAMI, obtained by researcher Sue Weibert, shows the TeenScreen crew telling the army of NAMI members from all across the country that helping set up TeenScreen might require contacting a child's insurance company to check on coverage or driving a child to an appointment with a psychiatrist.

The video also shows the presenter passing around a notebook for signatures from members who would be willing to act as volunteers and rise up against anyone who speaks out against TeenScreen.

The presenter also explains the importance of bribing kids with movie coupons, pizza or other perks, because parents won't agree to allow the children to be screened, so they need to win the kids over first and send them home to talk the parents.

Early on, NAMI and TeenScreen did not even hide the fact that drug money was funding the screening. In June 2002, the Tennessee Department of Mental Health and Developmental Disabilities Update Newsletter reported that NAMI and Columbia University sponsored the screening of 170 Nashville students with TeenScreen and that the survey was funded by grants from AdvoCare and Eli Lilly.

But two years later, in March 2004, Ms Flynn appeared at a congressional hearing trying to drum up the allocation of tax dollars to set up TeenScreen in public schools. During her testimony, she as much as defined the customer base the drug companies were after when she told the lawmakers that, "close to 750,000 teens are depressed at any one time, and an estimated 7-12 million youth suffer from mental illness."

On September 27, 2007, psychologist Michael Shaughnessy, professor in Educational Studies at the Eastern New Mexico University and columnist for the educational news and information site, EdNews.org, was interviewed about his views on TeenScreen by Doyle Mills, an independent researcher in Clearwater, Florida who was instrumental in blocking TeenScreen from setting up shop in schools in Pinellas and Hillsborough Counties, two of Florida's most populated counties, and has published several articles critical of TeenScreen.

Mr Mills shared his interview with Dr Shaughnessy at the ICSPP conference, in which the Professor called TeenScreen "a program aimed at locating, identifying and procuring new customers for the mental health industry."

He says TeenScreen is a creation of psychiatrist David Shaffer, a paid spokesman for Lilly and paid consultant for drug companies Hoffman la Roche, Wyeth and Glaxo.

TeenScreen started out by claiming the program was free and required no government funding. But as it turns out, taxpayers are funding this marketing scheme from start to finish. Government money is being used to set up TeenScreen in schools all over the US and tax dollars are paying not only for the follow-up visits to prescribing shrinks but also for the majority of drugs prescribed.

The pilot programs of TeenScreen in five counties in Ohio were funded by five $15,000 grants allocated by mental health boards within the Ohio Department of Mental Health.

Medicaid record show that taxpayers in Ohio are footing the bill for most of the child drugging as well. In July 2004, over 39,000 children covered by Medicaid were found to be taking drugs for depression, anxiety, delusions, hyperactivity and violent behavior, and Medicaid spent more than $65 million for mental health drugs prescribed to children in 2004, according to an investigation by the Columbus Dispatch.

The massive drugging of patients covered by public health care programs is similar in states all across the US. In 5 years, prescription costs for Iowa Medicaid increased 82.5%, and by class, antipsychotics reflected the largest increase for mental health drugs.

In 2005, while the average cost for a first generation antipsychotic to Medicaid was only $36 a month, a month's supply for a new antipsychotics cost between $100 - $1,000, according to the December 8, 2005, Mental Health Subcommittee Report to the Medical Assistance Pharmaceutical and Therapeutics Committee.

For the record, TeenScreen is not free, and it is costing tax payers a bundle. On November 17, 2004, the University of South Florida announced the receipt of a grant of $98,641 from the US Substance Abuse and Mental Health Services Administration to expand the TeenScreen program in the Tampa Bay area.

Florida Medicaid is also being bilked. On July 29, 2007, the St Petersburg Times reported that, in the last 7 years, the cost to taxpayers for atypicals prescribed to kids rose nearly 500%, and on average it cost Medicaid nearly $1,800 per child in 2006.

The Times reported that more than 18,000 kids on Medicaid were prescribed antipsychotics in 2006, including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration says that, with children under 6, psychotropic drugs should "only be considered under the most extraordinary of circumstances."

In setting up TeenScreen to screen students in Brimfield, Illinois, "organizing the system and employing a part-time counselor specifically for the program is estimated to cost about $100 per student," the July 11, 2005, Peoria, Illinois Journal Star reported.

Overall, the "Brimfield High School program alone will cost around $20,000 for the first semester," the Journal noted.

The TeenScreen gang claims that it always obtains parental consent prior to screening students and that it does not diagnose students with mental disorders.

However, Michael and Teresa Rhoades, from Indiana, attended the DC conference and as a featured speaker, Teresa described how her daughter was TeenScreened in December 2004, without parental consent, and was told that she had not one, but 2 mental illnesses.

Teresa recalled the day that her distraught daughter came home and informed her parents that she had been diagnosed with obsessive compulsive disorder and a social anxiety disorder.

Michael and Teresa say they were furious to the point that they filed the nation's first lawsuit against TeenScreen, charging that their daughter was wrongly screened, diagnosed, and labeled mentally ill in a public school without their consent.

"TeenScreen itself is a questionnaire with invasive and probing questions which indoctrinate young people into a belief that all their feelings and behaviors are indications of a mental disorder," Dr Shaughnessy told Mr Mills in the interview.

He said, "the child is convinced of it, the parent is convinced of it, and then the child becomes a customer of TeenScreen's local mental health 'partner,' which sells counseling or drugs and profits tens of thousands of dollars per child."

Dr Shaughnessy acknowledged that adolescence is a hard time for everyone but said, "maybe it's supposed to be," that's how we learn.

He says TeenScreen labels the normal pain and uncertainty of adolescence as a mental disorder for profit and asks, "When did adolescence become a disease or something unnatural or deadly that needs intervention if anyone is going to make it through?"

""What a ridiculous concept," Dr Shaughnessy added.

He also points out that school records for children are intended to be secure but says, once committed to paper or computer, nothing can be 100% secure. "Normal school records are fairly harmless no matter who sees them," he states.

"TeenScreen records on the other hand," he warns, "contain unscientific evaluations which can be taken to mean that the child has a permanent, incurable mental disorder."

He also says these records can then be used against a child as an adult, to take away his rights, limit his opportunities or "just as a horrible embarrassment."

"As there is no scientific way to prove that anyone has a mental disorder," Dr Shaughnessy points out, "there is likewise no scientific way to disprove it."

He told Mr Mills that this is one aspect that parents are never made aware of prior to allowing TeenScreen access to their children. "Once a person is diagnosed, he may never be able to escape that label," he warns.

Attorney Subpoenas J&J, AstraZeneca and Lilly for Hidden Antipsychotic Data - Part I

Evelyn Pringle September 10, 2007

Alaska attorney Jim Gottstein has issued subpoenas for the discovery of any suppressed data on the atypical antipsychotic drugs Zyprexa, Risperdal, and Seroquel which he says is necessary before a Forced Drugging Petition can possibly be considered for approval for a client he is representing.

Mr Gottstein contends that the information sought from Eli Lilly, AstraZeneca and Johnson & Johnson will show that the side effects of the drugs were well-established by the drug makers' own clinical trials and therefore, his client should not be forced to take such medications against his will.

According to Mr Gottstein, various off-label combinations of Risperdal, Seroquel, Zyprexa and the anti-seizure drug Depakote have been administered to his client in the past, over his objections, which have not been FDA approved as safe or effective for use in any patient.

The subpoena issued to Sidney Taurel, Chairman and CEO of Eli Lilly calls for the production of the same documents requested by Congressman Henry Waxman (D-Cal), as chairman of the House Oversight and Government Reform Committee, on March 1, 2007.

On March 1, 2007, Rep Waxman sent letters to both Lilly and AstraZeneca, requesting extensive information about their marketing practices. The letter to Lilly states in part, "Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa," and requests information relevant to these allegations.

The letter asks for a list of all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.

The letter to Astra basically asks for the same documents except that Rep Waxman asks for more information related to the physicians and authors involved in company sponsored studies on Seroquel and writing the reports.

However, Rep Waxman also asked Lilly to turn over a batch of documents that were kept under seal for years with a court order issued by a federal court in New York, but were provided to him by Attorney Gottstein in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

Mr Gottstein originally obtained the documents by subpoenaing Dr David Egilman, who served as a plaintiffs expert witness in the Zyprexa Products Liability litigation, pending in the United States District Court in the Eastern District of New York (MDL 1596), for a case unrelated to the Products Liability case.

The MDL 1596 litigation involved tens of thousands of lawsuits filed by Zyprexa victims who alleged that Lilly illegally marketed the drug for off-label uses and concealed the serious side effects known to be associated with Zyprexa for a decade.

As soon as Mr Gottstein received the documents he provided copies to reporter, Alex Berenson, at the New York Times, and to a number of other journalists, patient rights activists and advocacy groups and several leading experts on psychotropic drugs.

Once a medication is approved to treat one condition, doctors may prescribe it off-label for other indications if they think it will be effective, but drug makers are barred by law from encouraging physicians to prescribe a drug for uses other than those listed on the FDA approved label. But in recent years, its a well-known fact that off-label promotion has become the industries primary marketing tool when it comes to psychiatric drugs.

"Off-label" use also includes treating an approved condition for a longer duration of time, or in combination with other drugs, or at a different dosage, or with a different patient population such children or the elderly, than are listed on the label.

Zyprexa (Lilly), Risperdal (J&J) and Seroquel (AstraZeneca) belong to a class of drugs known as "atypical" antipsychotics. The other atypical drug include Abilify (Bristol Meyers Squibb), Geodon (Pfizer) and Clozril (Novartis).

The drugs were FDA approved only to treat schizophrenia and the manic phase of bipolar disorder in adults and have never been approved for use in combination with each other.

The many lawsuits filed against Lilly allege that the company's off-label marketing campaigns included influencing doctors to prescribe the drug to millions of patients ranging from toddlers to the elderly for an exhaustive list of unapproved uses such as anxiety, sleep disruption, mood swings, post-partum depression, autism, attention deficit hyperactivity and dementia.

According to Harrisburg Pennsylvania psychiatrist, Dr Stefan Kruszewski, the atypical drugs can increase the risk of drastic weight gain, diabetes, pancreatitis, hypertension, heart attacks and stroke.

"The drugs can cause both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," he explains, "at the same time that they cause the neurological side effects as the older antipsychotics such as akathesis, a severe restlessness and tardive dyskinesia an often irreversible movement disorder."

As an expert witness in the case, Dr Egilman reviewed the Lilly documents kept under seal by the court order and learned that Lilly had indeed engaged in a massive off-label marketing scheme to increase profits by encouraging doctors to prescribe the drug for unapproved uses and had concealed the drug's serious side effects.

As a physician, after learning what was in the documents and knowing the harm that was sure to come to patients who continued to take Zyprexa, Dr Egilman was clearly facing a major ethical dilemma.

At the time, Lilly had already managed to keep the documents hidden by settling out of court with about 8,000 Zyprexa victims in 2005 by paying close to $700 million, after only five plaintiffs had provided depositions and before any substantive depositions could be taken from any of the Lilly defendants.

And the first batch out of court settlements did nothing to deter the off-label sales of Zyprexa. According to Lilly's SEC filings, sales in the second quarter of 2006 totaled $1.12 billion, or a 2% increase over the second quarter of 2005.

In addition, Dr Egilman was aware that the company was getting ready to settle with about 18,000 more Zyprexa victims, and that the second round of settlements would guarantee that the secret documents would remain sealed.

And as a condition of settlement, the 28,000 plaintiffs had to sign agreements promising never to discuss the charges made against the company related to Zyprexa.

According to several plaintiffs who settled out of court, they we were not aware that there were documents that showed in many instances that Lilly knew full well that the injuries suffered could occur and had intentionally concealed the information from doctors and patients because it would have had a negative impact on Zyprexa sales.

In fact, these plaintiffs said they were never told that these secret documents even existed much less that by signing settlement agreements they would be allowing more patients to be injured or killed because the documents would remain sealed.

They also said that they were completely surprised to learn that their attorneys had access to documents that could have been presented to a jury to prove that the allegations in their lawsuits were true when the media began reporting the story in December 2006.

For instance, a November 12, 1999, letter from a Dr Albert Marrero, to Lilly's medical director, described the blood sugar problems occurring in patients. "We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars," he stated.

Dr Marrero also told Lilly: "Two patients had to be hospitalized due to out of control diabetes....We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent," he wrote.

A November 1999 report showed that after examining 70 clinical trials, Lilly found that 16% of patients on Zyprexa for a year had gained over 66 pounds but instead of informing doctors of this information, the company used data from a smaller group of trials to say about 30% of patients gained only 22 pounds.

Another document showed that in 2000, after a group of diabetes doctors retained by Lilly substantiated the diabetes risk, a Lilly manager stated in an email, "unless we come clean on this, it could get much more serious than we might anticipate."

A email dated two years later in March 2002, shows that Lilly shot down a plan to provide doctors with information about diabetes, because it would draw too much attention the risk. "Although M.D.'s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa," the email stated.

Although the documents clearly show that Lilly had knowledge of these life-threatening health risks in 1999, it did not add a warning about blood sugar levels and diabetes to the Zyprexa label until the FDA forced it to in the fall of 2003. In fact, Japan and the UK issued warnings about the increased risk of diabetes in 2002.

According to Ellen Liversridge, whose son took Zyprexa and gained 100 pounds before he fell into a coma and died of profound hyperglycemia in 2002, "both the FDA and Lilly fought putting a warning on the label, until articles on the front pages of the New York Times, Baltimore Sun, and Wall Street Journal so embarrassed the FDA that they finally gave in to adding the warnings."

But even then she says, the FDA required the same warning on the labels of all atypical drugs, "when Zyprexa was associated with a 37% higher increase in the risk of diabetes when compared to other medications."

However, the secret documents show that Lilly was hard at work behind the scenes to make sure that the new warnings would have minimal effects on Zyprexa sales. A July 7, 2003, memo titled, "Diabetes Update," described a plan to protect doctors who were afraid of being sued for prescribing Zyprexa after the news of the diabetes risk became public that would indemnify doctors who continued to prescribe drug

"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Update said,
"solely on the basis of personal fear (of being sued)."

"Indemnification represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees," it stated.

The memo also discussed a plan to pay millions of dollars to the National Alliance on Mental Illness, the most notorious industry backed front group in the nation, to help downplay the news about the diabetes risk.

The public health crisis created by patients who developed diabetes as a result of using Zyprexa is real. A Medicaid fraud lawsuit filed against Lilly by the attorney general of Mississippi in July 2006, alleges that about 10% of patients who used Zyprexa in that state have developed insulin-dependent diabetes and some are children, the complaint says.

When forced to make a decision on whether to warn the public about Zyprexa or abide by a court order that could result in the death and injury of thousands upon thousands of more people, Dr Egilman obviously followed the natural instinct of any decent human being and gave up the documents.

Whether or not he actually realized what consequences he might face is anyone's guess, but he no doubt recognizes the consequences of crossing the drug giant today.

On September 7, 2007, Lilly issued a press release with the headline: "Egilman Admits Wrongdoing in Illegally Releasing Documents to New York Times and Resolves Case to Avoid Possible Civil and Criminal Sanctions".

The release said that Dr Egilman will pay $100,000, and in return, the company "agreed to forego seeking criminal and civil penalties against Dr. Egilman for his illegal activities."

Although it will be interesting to see how many "Good Samaritans" will stick their neck out for the common good after hearing about Dr Egilman's fate, it is apparently still easy to find doctors willing to prescribe Zyprexa off-label because SEC filings show Lilly earned $4.36 billion from the drug in 2006

With all that said, on September 6, 2007, it was certainly a Deja Vue moment when the judge in Mr Gottstein's latest case against forced drugging in Alaska, issued an order to have the court hearing and file closed, even though the client had elected to have it open.

Attorney Subpoenas J&J AstraZeneca and Lilly for Hidden Antipsychotic Data - Part II

Evelyn Pringle September 10, 2007

Attorney Jim Gottstein is the director of the Law Project for Psychiatric Rights, a public interest law firm that has mounted a campaign against forced psychiatric drugging all over the country. He represents mostly indigent clients through his non-profit organization and is not involved in the lawsuits filed against the atypical makers by patients or their families.

In turning the secret Eli Lilly documents over to the press, Mr Gottstein's goal was the same as Dr David Egilman's, to alert the public about Lilly's off-label marketing schemes aimed at getting doctors to prescribe Zyprexa to more patients who were unaware of the serious health risks associated with the drug.

Zyprexa was approved only for the treatment of adults with schizophrenia in 1996, and it wasn't until several years later, that it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.

In a February 13, 2007, interview with the Anchorage Daily News, Mr Gottstein explained that the secret document showed the rate at which Zyprexa caused diabetes, massive weight gain and other metabolic problems and how Lilly trained sales staff to mislead doctors about the drug's association with diabetes and illegally promoted Zyprexa for off-label use with children and the elderly.

As the playing field stands today, the average American alone would be lucky to find any law firm financially strong enough to take a drug giant like Lilly with its billions of dollars of power and a well that will never run dry in large part because the illegal off-label marketing of Zyprexa is ongoing and continues to earn billions of dollars each year.

However, a small group of patient advocates that included some of the most well-known psychiatric drug experts, journalists, and attorneys in the US went head to head with Lilly in the public battle in a US District Court in New York that dragged out over 2 months to lift an injunction that barred the public disclosure of information about the serious adverse effects of Zyprexa that Lilly had successfully kept hidden under a court order until the documents were leaked to the press in December 2006.

Lilly filed the motion for the injunction in attempt to get the documents back under seal and succeeded in muzzling just about every expert in the US involved in the fight to dismantle the mass-drugging schemes put in place by the pharmaceutical industry over the past 10 years including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, and Dr Stefan Kruszewski, as well as the award winning journalist, Robert Whitaker, who wrote "Mad in America," and revealed all the negative information that showed up in the clinical trials conducted on Zyprexa and the other atypicals.

The score looked bad for the home team early on when Lilly won the second round by getting the court to add the names of two of the world's most powerful patient advocacy groups to the injunction, along with their internet web sites and leaders, including Vera Sharav, director of the Alliance for Human Research Protection, and Judy Chamberlin and David Oaks from the international organization MindFreedom, a coalition of about 100 advocacy groups in 13 different countries.

At the time, Mr Oaks said, "This appears to be about Eli Lilly using its billions of dollars to try to intimidate grassroots critics."

The New York legal battle turned into an all out war when Ms Sharav and Dr Cohen brought in the high profile attorney, Alan Milstein, to file their own motion asking the judge to unseal the documents because they should have never been designated confidential to begin with.

"What is abundantly clear," Mr Milstein told the judge in a hearing, "is that they are not trade secrets."

"Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo," he said.

"What Lilly wants to prevent, is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it," Mr Milstein said in the hearing.

Alaskan Attorney, John McKay, stepped in to represent Mr Gottstien and his wife Terrie, and then attorney, Fred von Lohmann of the Electronic Frontier Foundation, widened the battlefield by filing a brief on behalf of John Doe, described as a citizen-journalist who wanted to publish the secret documents on web sites because they were "plainly related to a matter of overriding public concern."

California attorney, Ted Chabasinski, jumped in the ring on behalf of Robert Whitaker, Judi Chamberlin, and David Oaks. "While the injunction purports to be an attempt to recover the documents," he wrote in a letter to the judge, "it is clear that its real purpose is to intimidate Lilly's critics, and the court should refuse to cooperate with this."

Mr Chabasinski told the court that criminal charges should be filed against Lilly executives for illegally marketing Zyprexa for unapproved uses, with full knowledge that thousands of patients were being injured and killed. "If executives can go to prison for stealing their companies' money," he told the judge in a letter, "surely those who steal people's lives deserve at least the same fate."

Mr Chabasinski informed the court that the secret documents were evidence of Lilly executives' "criminal behavior" and their "willingness to kill people for profit." He also made it known that he was encouraging members of the public to contact state attorney generals and was directing private citizens to a list of current contact information for each state posted on the Mindfreedom web site.

And some citizens did just that. Richard Bleecker, whose nephew died unexpectedly of hyperglycemia due to Zyprexa, wrote to the New Jersey attorney general and stated: "In your capacity as New Jersey's Attorney General, I ask that you launch an investigation into Eli Lilly's violation of the public interest by its concealment of the risks of Zyprexa."

"Despite the FDA restrictions on use and warning labels," he wrote, "the drug continues to be vigorously promoted by Lilly and prescribed for patients in record numbers, including children."

He pointed that the state itself had an interest in the matter "since government programs like Medicare and Medicaid purchase over 70% of the Zyprexa sold in the USA, taxpayers in our State as well as across the nation are footing most of the bill."

"I appeal to you, to investigate Eli Lilly's willingness to see patients suffer and die to enhance its profits," Mr Bleeker wrote.

Over 10 states have now sued Lilly for Medicaid fraud over the off-label marketing of Zyprexa. And for good reason according to a report in the March 23, 2007, New York Times, that said Zyprexa costs more than $300 a month and is the single biggest drug expense for state Medicaid programs with spending of more than $1.3 billion in 2005.

During court hearings, several people restrained by the injunction testified about why the documents should be made public which resulted in media reports about what was in them before the legal battle even ended.

For instance, at a January 17, 2007, hearing, Mr Gottstein was asked, "at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?"

And he answered: "Absolutely."

He was then asked whether he feared there would be thousands more cases of harm to people from Zyprexa, while Lilly was settling cases out of court, and Mr Gottstein said yes, and that he wanted the documents released "to protect people from this drug."

Mr Milstein told the judge that the documents were critically important to saving human lives and said, "this Court should in no way assist Lilly in keeping them from the public."

At the same hearing, Lilly attorneys asked Ms Sharav why she was interested in the documents and she said because they documented the fact that Lilly knew in 2000, that Zyprexa caused diabetes, "from a group of doctors that they hired who told them you have to come clean."

"And instead of warning doctors who are widely prescribing the drug, Eli Lilly set about in an aggressive marketing campaign to primary doctors," she testified.

Ms Sharav told the court, "This is a safety issue," and "to continue to conceal these facts" from the public "is not in the public interest."

She said, "this is about the worst that I have seen."

"It borders on indifference to human life," she told the judge. "Eli Lilly knew that Zyprexa causes hypoglycemia, diabetes, cardiovascular damage and they set about both to market it unlawfully for off label uses to primary care physicians."

She said Lilly taught primary care doctors to diagnose patients as bipolar if they experienced mania after taking antidepressants. "That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General," she testified.

Mr Sharav also objected to the off-label sale of Zyprexa to kids. "Little children are being exposed to horrific diseases that end their lives shorter," she testified.

She said, "the reason the drug became a four and a half billion dollar seller in the United States is because they encouraged the prescription for children, for the elderly, for all sorts of reasons."

"I consider that a major crime," she told the judge and said she asked Mr Gottstein for 2 copies of the documents so that she could deliver one copy to the New York attorney general.

By the time of that hearing, Ms Sharav no doubt was aware that the crime was ongoing because in January 2006, USA Today reported that although the atypicals are not approved for any use with children, the prescription rate for children "is growing dramatically faster than the rate for adults," quoting Robert Epstein, chief medical officer for Medco Health Solutions, pharmacy benefit managers.

In addition, an assessment by Christoph Correll, of the Child and Adolescent Psychiatric Clinics of North America, showed Zyprexa to be the worst of the atypicals for kids and listed the side effects of diabetes and weight gain with the drug as "severe."

Technically, on February 13, 2007, Lilly scored a knock-out punch when the judge issued a permanent injunction prohibiting Mr Gottstein and Dr Egilman from further disseminating the documents and allowed Lilly to keep them sealed under a court order.

However, the judge also acknowledged in his written ruling that there was no way he could not enjoin the world by extending the injunction to the internet and by that time the worldwide web was flooded with all the damning information.

And Lilly would soon learn that the push to make the information public extended far beyond the courtroom. On February 23, 2007, a grass roots advocacy group issued a press release to rally support for Mr Gottstein for providing the documents to the media and to announce the "The Just Say "Know" to Prescription Drugs Campaign," with a goal of getting one million people reevaluate the prescription drugs they were taking.

"If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it," said Dr Greg Tefft, co-founder of the Campaign.

"We're talking 20 million people potentially at risk and more being added daily," he added.

The group set out to educate the public about off-label prescribing and what consumers must do to protect themselves against Zyprexa, or other drugs, when they are prescribed without warnings about side effects or unapproved uses.

"We are convinced that the way to solve this problem is to work the demand side of the market," Dr Tefft said. "We are going directly to consumers and encouraging them to know what they are taking."

Chairman of the Campaign, Dr Dominick Riccio, hosted a Zyprexa radio series and Dr Laurence Simon provided information to consumers about the drug and they set up an official web site for the Campaign is http://justsayknow.kpncradio.com

A month and a half later, on April 4, 2007, the ranking Republican on the Senate Committee on Finance, Senator Charles Grassley (R-Iowa), was knocking on Lilly's door with a letter to the CEO saying, "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," he said, "and questions have been raised regarding safety information and marketing practices relating to that drug."

Senator Grassley also wrote, "I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee," referring to leaked documents and said, "please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available ... pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig."

And in the end, it could be said that injunction or no injunction, the small group of warriors led by Mr Gottstein and Dr Egilman, who bravely banded together against the billion dollar giant helped make Lilly's worst nightmare come true by fighting against the injunction and keeping the spotlight on the documents that the company fought so hard to keep hidden, not so much from the public, but from the stockholders.

According to legal experts, Lilly's desperate filing for the injunction had nothing to do with the lawsuits filed by private plaintiffs because that litigation was the least of its worries being the company was settling the cases for peanuts with plaintiffs signing confidentiality agreements that would shut them up for life.

However, following the public disclosure of proof that Lilly had engaged in a 10-year illegal off-label marketing scheme while concealing the adverse effects of Zyprexa, the company was hit with the big Kahoona, when 4 class action lawsuits were filed in April 2007 on behalf of shareholders, alleging the fraud by Lilly and its top executives had cost them more than $30 billion, and the evidenced cited to support the allegations was the information from the secret documents that resulted in the battle over the injunction.

It remains to be seen whether these shareholder lawsuits will do anything to stop the drugging of kids in the US because as it stands right now the mass drugging campaign appears to be unstoppable. On September 5, 2007, Rob Waters reported that the number of antipsychotic prescriptions for children doubled to 4.4 million between 2003 and 2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a drug-tracking firm.

Mr Waters also reported that the growth was most dramatic in the youngest children with 20,280 prescriptions written for kids aged 4 and younger, a five-fold increase over 2003, and with 5- to 9-year-olds, prescriptions increased almost six-fold to 710,937 in 2006.

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part I

Evelyn Pringle August 30, 2007

On August 21, 2007, the Associated Press reported that drug companies spend a lot of money on the members of Minnesota advisory panels who help select the drugs which are to be used by patients covered by Medicaid.

The news agency's review of financial disclosure records in Minnesota found that a doctor and a pharmacist on the 8-member panel simultaneously received large checks from drug companies for speaking about their products.

According to the report, Minneapolis psychiatrist John Simon, appointed to the panel in 2004, earned $354,700 from drug makers that included Eli Lilly and AstraZeneca, from 2004 to 2006, in honoraria, speaker and consulting fees, as well as other payments ranging from $500 to $93,012.

The records also showed that Robert Straka, a University of Minnesota pharmacy professor, was paid $78,000 by drug companies while he served on the panel from 2000 to 2006. He told the Associated Press that he was paid for "educational talks" and that he routinely discloses his ties with drug companies and did so as a panel member, both verbally and in writing.

But according to information obtained with a public records request by the AP, there is no indication that Mr Straka made any such disclosures in meeting minutes dating back to February 2001, and other panel members and staff interviewed by the AP could not remember Mr Straka making any such disclosures either.

The Associated Press reported that roughly a third of the drugs on Minnesota's preferred drug list were sold by companies which paid Mr Simon or Mr Straka, but the news agency could not track any link between the payments and their votes because the minutes from the advisory panel meetings did not record how the 8 members voted.

The top-selling drugs prescribed to Minnesota Medicaid patients for the years 2000 through 2006 included the atypical antipsychotic drugs Zyprexa, marketed by Eli Lilly; Seroquel, sold by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.

These drugs were originally FDA-approved for the limited use of treating adults with schizophrenia or the manic phase of bipolar disorder. However, the massive over-prescribing of this enormously expensive class of drugs for unapproved uses has caused many states to remove them from the Medicaid preferred drugs lists and requires doctors to obtain prior authorization before prescribing them to Medicaid patients.

In fact, roughly 10 states are now suing several atypical makers for Medicaid fraud to recoup the cost of purchasing the antipsychotics prescribed off-label to Medicaid patients and also to recover the money paid for medical care of the persons injured by the drugs.

The lawsuits allege that the drug makers illegally influenced doctors to prescribe the drugs off-label to patients of all ages, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, dementia, and many other unapproved indications, and concealed the adverse effects associated with the drugs.

The atypical makers are also facing tens of thousands of lawsuits filed by patients, private insurance carriers and company shareholders for similar allegations.

According to Lilly's August 6, 2007, SEC filing, since August 2006, Lilly has received civil investigative demands or subpoenas from a number of states. "Most of these requests are now part of a multistate investigative effort being coordinated by an executive committee of attorneys general," the filing states.

"We are aware that approximately 30 states," Lilly wrote, "are participating in this joint effort, and it is possible that additional states will join the investigation."

The filing notes that the attorneys general are seeking a broad range of Zyprexa documents, "including documents relating to sales, marketing and promotional practices, and remuneration of health care providers."

Presumably, that would also include the "remuneration" of Minnesota shrinks like Dr Simon. According to the August 27, 2007, Pioneer Press, since 2002, Dr Simon has received more than $570,000 from six drug makers, with most of the money coming from Eli Lilly, "whose antipsychotic drug Zyprexa is the most costly each year for Minnesota's fee-for-service health program for the poor and disabled," the article states.

In fact, Lilly's disclosure records for 2004 show payments to Dr Simon totaling a whopping $91,854.95 in that one year, and he also received another couple grand from Seroquel maker AstraZeneca.

Dr Simon told the Pioneer Press that companies pay him to speak about their drugs at conferences and clinics or about the conditions that are treated with the drugs. "Most of the psychiatrists who are really good," he said, "have ties to industry."

Whether Dr Simon is a "really good" psychiatrist is certainly open to debate. In 1997, the state medical board made him complete a clinical training program and issued a report which said that Dr Simon, "frequently makes abrupt and drastic changes in type and dosage of medication which seem erratic, not well considered and poorly integrated with nonmedication strategies."

The board also noted that Dr Simon prescribed addictive drugs to addicts and failed to stop giving medicines to patients when they were suffering severe drug side effects. He said in an interview with the Times that the board's action was a learning experience and that drug makers continued to hire him to speak because he was respected by his peers.

For years, Dr Simon reportedly shared an office with another "really good" psychiatrist by the name of Dr Faruk Abuzzahab. On June 3, 2007, Gardiner Harris and Janet Roberts published a story in the New York Times with the headline: "After Sanctions, Doctors Get Drug Company Pay," and stated:

A decade ago, the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a "reckless, if not willful, disregard" for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.

Over the past 20 years, this "really good" psychiatrist has repeatedly prescribed narcotics and other controlled substances to addicts and prescribed narcotics to pregnant women, one of whom delivered a baby prematurely that died, the board found.

The Times reports that separately, in 1979 and 1984, the FDA concluded that Dr Abuzzahab had violated the protocols of every study that the agency audited and that he reported inaccurate data to drug makers.

The FDA said he routinely oversaw 4 to 8 trials at the same time, moved patients from one study to another, gave experimental drugs to patients at their first consultation and once hospitalized a patient for the sole purpose of enrolling him in a study.

As recently as June 2006, the medical board criticized Dr Abuzzahab once again for writing prescriptions for narcotics and this time to patients he knew were using false names, according to the Times.

All that said, Dr Abuzzahab told the Times that he has helped study many popular psychiatric drugs, including Lilly's Zyprexa and Prozac, Janssen's Risperdal, AstraZeneca's Seroquel, Glaxo's Paxil and Pfizer's Zoloft.

A review of the Minnesota disclosure records for 2004 show that the drug makers apparently thought it was beneficial to keep paying big bucks to Dr Abuzzahab. Glaxo paid him $1,000, Pfizer gave him $750, and Wyeth forked over $18,084, in that year alone.

In 2003, psychiatrist Dr Ronald Hardrict pleaded guilty to Medicaid fraud. But a little charge like fraud apparently did not effect this Minnesota psychiatrist's earning power either. The very next year, disclosure records for 2004 show Risperdal maker Janssen paid him $10,000; Seroquel maker AstraZeneca gave $1,250; Abbott Labs paid him over $7500; Glaxo paid $1,500, and Wyeth forked over $8,846.

In reviewing the Minnesota disclosure records for 2004, the name Dr Dean Knudson kept popping up. A September 2004 Newsletter from the Ada Canyon Medical Education Consortium listed Dr Knudson as an associate professor of psychiatry at the University of Minnesota Medical School.

He must be a "really good" psychiatrist, too, because in 2004 alone, Lilly paid him close to $37,000; he earned nearly $2,750 from Pfizer; Seroquel maker AstraZeneca paid him $6,700; Janssen forked over $3750; Wyeth paid him $11,632, and he received $2,082 from Abbott. Lilly's 2003 forms also show another $8,740 paid to Dr Knudson.

The newsletter showed that Dr Knudson was paid to give educational presentations on dementia. On October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia raised their risk of death.

For the study, the researchers pooled the results of 15 studies on the atypicals Zyprexa, Risperdal, Seroquel and Abilify and among more than 5,000 dementia patients, those taking any of the four drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.

Another name that jumps out in the 2004 disclosure records is Dr David Adson. According to the August 20, 2007, Pioneer Press, Dr Adson, of the University of Minnesota, also has a state advisory role as the clinical leader of a program funded by Lilly and provided free of charge to Minnesota, which notifies doctors when their prescriptions for psychiatric drugs are out of line with clinical standards.

Although the program is funded by Lilly, it is supposedly run by an independent company called Comprehensive NeuroScience, Inc. All totaled, 20 states have contracts with CNS to identify doctors "who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness," according to the Press.

Critics say the program is actually a scam set up with state policy makers to make sure the expensive psychiatric drugs remain on the Medicaid covered drug lists instead of being placed on the lists that require prior authorization.

Ben Hansen, a member of the Michigan Department of Community Health Recipient Rights Advisory Committee, has been investigating the atypical makers' involvement in the Medicaid programs in Michigan and other states and says that none of the states with CNS contracts require prior authorization for the atypical drugs.

Mr Hansen published some of the results of his investigation in the Spring 2007 Newsletter of the International Center for the Study of Psychiatry and Psychology. By using the FOIA, Mr Hansen says he has obtained nearly a thousand pages of documents which show that Medicaid is being "milked like a huge cash cow."

According to Allen Jones, a former Medicaid fraud investigator, the long list of corporate sponsors for CNS includes: AstraZeneca, Janssen, Bristol-Myers, Pfizer, Lilly and Glaxo.

Back in 2002, Mr Jones found that Janssen was using CNS to funnel payments to state officials who controlled the Medicaid preferred drug lists in Pennsylvania to ensure that Risperdal would be on the list.

For his part, the leader of the Minnesota CNS program, Dr Adson, was paid $5,200 by AstraZeneca, Glaxo shows $331,947 going to him, and Pfizer gave him $1,000, in 2004 alone.

Also, in 2006, Dr Adson received $83,325 from AstraZeneca and roughly $6,100 from Bristol-Myers, according to a compilation of disclosure forms by the Pioneer Press and the watchdog group Public Citizen.