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).
Showing posts with label front groups. Show all posts
Showing posts with label front groups. Show all posts
Friday, November 19, 2010
Sunday, August 8, 2010
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."
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.
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.
Lawmakers Want to End Big Pharma Recruitment Schemes - Part 2
Evelyn Pringle May 30, 2007
The whole idea of mining for psychiatric drug customers by screening all Americans for mental health disorders came to fruition as the result of the campaign contributions by the pharmaceutical industry, which in large part helped George W Bush take up residence in the White House.
To repay his enormous debt to the industry, on April 29, 2002, Bush paved the way for the implementation of the industry-funded screening programs and the mass drugging-for-profit scheme when he created the New Freedom Commission.
According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, It is merely one of the "Bush administration hand-outs to the drug companies, so many of which have changed from legitimate businesses into patent-protected rackets."
The recruitment of children as customers was a central goal of the industry, and Bush came through in helping meet that goal. The NFC's final report dated July 22, 2003, called for screening every American child for mental illness, including preschoolers, and said, "schools are in a key position to identify mental health problems early and to provide a link to appropriate services."
To that end, the report says, every child involved in a government program or is covered by Medicaid will automatically be screened under the following recommendation: "Screening should be implemented upon entry into, and periodically thereafter in, the juvenile justice and child welfare systems, as well as in other settings and populations with known high risk, such as the Medicaid population."
The report also specifically calls for screening programs to be linked to "state-of-the-art treatments" using "specific medications for specific conditions." A fact not mentioned is that 95% of the "specific medications" referred to were not FDA approved for treating children and have never been tested as safe and effective with children.
In addition, recent studies have shown that, although the rise in numbers of patients taking psychiatric drugs has skyrocketed over the past decade, there has been no decrease in mental illness. To the contrary, judging by the company sales figures, the man-made epidemic is still spreading like a wildfire.
But worst of all, for all the money spent and the stream of new serious side effect emerging each year, no patients are recovering from their alleged "mental disorders."
The screening program recommended by Bush's Commission for use in the public school system was TeenScreen, which created a controversy all across the country when the survey began being administered to students without the knowledge or consent of the parents.
TeenScreen claims it can identify several mental disorders. On March 2, 2004, while trying to drum up federal funding at a Congressional hearing, TeenScreen's Executive Director, Laurie Flynn, testified that, in the screening process, "youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality."
Critics disagree. "The TeenScreen program is a fraud," says Dr Lehrman. "It makes 'mental cases' rather than finding them by giving youngsters brain-injuring medicines."
The Citizens Commission for Human Rights points out that "human beings have been bumping and bumbling their way through adolescence for a few hundred thousand years, at least."
"Now TeenScreen and its allies," it says, "want to turn that right of passage into a profit center of psychiatrists and their allied pharmaceutical companies," in the November 2006 report, "TeenScreen: Life Saving Intervention, or Orwellian Nightmares?"
In addition, critics say any label of mental illness will have many life-long adverse effects on these children. They will have problems filling out job applications and applying for insurance when they have to say they were diagnosed mentally ill in childhood.
And this will especially be true for those children who have to reveal that the drugs they were prescribed as a child were atypical antipsychotics used to treat schizophrenia or bipolar disorder leading most people to logically conclude that the person has a life-long mental illness.
The atypicals include Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon, none of which are FDA approved for any use with children and are only approved for treating schizophrenia and manic episodes of bipolar disorder in adults.
Think about it. What do most people think of when they hear the term schizophrenia? Rightly or wrongly, they envision people who are delusional, hear voices, unpredictable and violent. In other words, the person is at least bizarre and at worst dangerous to be around.
And also, there is no denying that such a label results in stigmatism for life, because when do we ever hear that a person "used to have" schizophrenia or bipolar disorder? By design, the drug companies are setting up children to become life-long customers by having them labeled with the most serious of mental disorders.
For nearly 20 years, the drug makers have been raking in profits by promoting the selective serotonin reuptake inhibitor antidepressants (SSRIs) which include Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, as working better than the older drugs and concealing the association between the drugs and suicidality.
"Parents must be better informed," according to a report by The Citizens Commission on Human Rights.
"Few, if any, parents faced with the school situation of their child being labeled as 'mentally ill' or 'learning disordered' and coerced into taking psychiatric drugs, are told that there are many other factors that could be causing the child's inattention, behavior problems or learning difficulties," CCHR states.
"Common causes," the report says, "are poor reading and math skills requiring tutoring, environmental toxins, allergies, nutritional deficiencies, and other easily detectable and treatable physical conditions."
Special medical doctors can do tests to determine if a person is experiencing an allergic reaction, and diet can also help, the report notes.
Critics who have investigated the TeenScreen program say it is being sold to the public by the funneling of millions of industry dollars through front groups posing as patient advocacy groups. "The National Alliance for Mental Illness (NAMI)," Mr Kramer says, "pushes suicide screening of children nationwide and receives millions in drug money."
NAMI received $544,500 from Eli Lilly in the first quarter of this year alone, he notes.
The industry definitely gets a lot of bang for the buck when using NAMI and other front groups. Internationally known expert and author of many books on psychotropic drugs, psychiatrist, Dr Peter Breggin, founder of The International Center for the Study of Psychiatry and Psychology (ICSPP), says groups like NAMI hold national meetings that bring together drug advocates to talk directly to consumers.
"They also send out newsletters and other information that praise the drugs," he says.
"Sometimes," he adds, "they actively suppress viewpoints that are critical of drugs, for example, by discouraging the media from airing opposing viewpoints."
According to Mr Kramer, the TeenScreen advisory board also has major ties to the pharmaceutical industry.
Psychiatrist David Shaffer, who is credited with the development of the TeenScreen survey, is a paid consultant for GlaxoSmithKline on the matter of Paxil and adolescent suicide and has served as an expert witness in lawsuits against plaintiffs injured by pharmaceutical products on behalf of Hoffman la Roche and Wyeth Pharmaceuticals.
In January 2004, Shaffer co-authored a report in the Journal of the American College of Neuropsychopharmacology that claimed, "SSRI antidepressants do not increase the risk of suicidal thinking or suicide attempts in youth."
By design, the report coincided with the scheduled FDA advisory committee hearings on the issue of whether SSRI use was associated with suicidality in children, and all authors but one had extensive ties to the industry. In the end, the panel ignored Shaffer's bogus study and determined that a black box warning should be added to SSRI labels.
A few months later, on December 9, 2004, ABC's Prime Time Live revealed that at least 100 children in the US had committed suicide while taking these new antidepressants and many more had attempted suicide.
The fact that SSRIs cause violence in some people was also concealed by the drug makers for years. As far back as November 2002, Fox News reported that 7 of the 12 teens involved in school shootings were either taking SSRIs or stimulants or were experiencing the withdrawal effects from the drugs and that the possible drug use by the other 5 shooters was unknown at the time because their medical records were sealed. Columbine shooter Eric Harris was on Luvox.
Critics say it's no coincidence that TeenScreen leader Laurie Flynn was the CEO of NAMI for 16 years before she was promoted to head TeenScreen.
Under Flynn, CCHR reports, NAMI became a virtual marketing arm of the industry, stating in its Guidelines for the Relationship between NAMI and the Campaign's Founding Sponsors: "Providers, health plans, and pharmaceutical companies want to grow their markets and to increase their share of the market...NAMI will cooperate with these entities to grow the market by making persons aware of the issues involving severe brain disorders...and by helping persons to adhere to their treatment plans."
An Indiana mother, Teresa Rhodes, has created an online petition against TeenScreen after her 15-year-old daughter, Chelsea, was screened at school without parental consent and was falsely labeled with not one but 2 mental illnesses, obsessive-compulsive disorder and social anxiety disorder. People wishing to sign the petition can do so by clicking on this link http://www.petitiononline.com/TScreen/petition.html.
Mr Kramer says the petition is an excellent way to educate people about TeenScreen because it conveys many of the facts about mental health screening and can be printed off and presented to school board members and local, state and federal legislators.
Activist Vince Boehm has been advocating against screening and the drugging of children for more years than he would like to count. However, he got especially upset recently while watching a discussion on TV about the positive business outlook for the sale of psychiatric drugs to children.
"I was listening to the Bloomberg Business Channel recently," he says, "and caught an interview with a drug company sales executive."
"He was talking about how his market share for psychiatric drugs was booming in the pediatric market," he recalled.
"Then I thought about the children," Vince said and screamed at the TV, "You jackass! (I actually used a somewhat stronger expletive), these are not 'market shares' they are kids!"
According to Laurie Yorke, "Pandora's Box is an understatement when it comes to mental health screening."
Laurie is a Registered Nurse whose son was labeled mentally ill and prescribed Paxil and experienced a severe withdrawal syndrome when he stopped taking the drug.
"I think one thing that is never mentioned with TeenScreen," she states, "is how is the school going to handle a child who has been labeled?"
"What if a child is diagnosed with an 'anxiety disorder,' she points out. "Is the school prepared to provide home instruction, smaller classrooms, or whatever is required to educate that child?"
"I bring this up," she notes, "because Ryan's school denied his withdrawal from Paxil, accused me of 'working the system' and attacked my reputation to all who would listen and finally withdrew his home instruction."
As a result, Laurie says, her son withdrew from high school altogether. "If this is how they treat someone who is 'labeled,'" she asks, "how are they going to provide an education for all of those who are being labeled because of TeenScreen?"
In addition, she points out, "how are they going to handle all the children suffering from adverse effects from a drug that they have been prescribed as a result of TeenScreen?"
On May 17, 2007, Laurie testified at a hearing in support of a New Jersey legislative bill that requires physicians and other prescribers to obtain informed consent from parents or guardians of minors who are prescribed psychotropic medication with "black box warnings," to include informing the parent or guardian of all the potential adverse events associated with the drug.
The bill specifies that a physician or other authorized prescriber who prescribes a medication in violation of this act shall be subject to disciplinary action by the State Board of Medical Examiners. The bill was approved by the State Assembly's Consumer Affairs Committee.
Before allowing children to take SSRIs, Mr Kramer recommends that at the very least, everyone should get educated on the black box warning which states: "Antidepressants increase the risk of suicidal thinking and behavior in children and adolescents."
"This FDA warning alone," he notes, "should be a wake-up call for any true suicide prevention effort."
The Alliance for Human Research Protection is taking activism a step further by kicking off a campaign urging restrictions on off-label use of all drugs that carry black box warnings.
"Inasmuch as these drugs are deemed by the FDA to carry life-threatening risks of harm," says AHRP director Vera Hassner Sharav, "their use should be restricted and off-label prescribing of these drugs should be off-limits!"
Bush's plan for screening the nation's roughly 36 million senior citizens is set up through the "Positive Aging Act of 2005." The Act provides federal tax dollars for community-based outreach teams to hunt down the elderly wherever they can be found whether it be at senior citizen centers, adult day care programs, or assisted living facilities.
The whole idea of mining for psychiatric drug customers by screening all Americans for mental health disorders came to fruition as the result of the campaign contributions by the pharmaceutical industry, which in large part helped George W Bush take up residence in the White House.
To repay his enormous debt to the industry, on April 29, 2002, Bush paved the way for the implementation of the industry-funded screening programs and the mass drugging-for-profit scheme when he created the New Freedom Commission.
According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, It is merely one of the "Bush administration hand-outs to the drug companies, so many of which have changed from legitimate businesses into patent-protected rackets."
The recruitment of children as customers was a central goal of the industry, and Bush came through in helping meet that goal. The NFC's final report dated July 22, 2003, called for screening every American child for mental illness, including preschoolers, and said, "schools are in a key position to identify mental health problems early and to provide a link to appropriate services."
To that end, the report says, every child involved in a government program or is covered by Medicaid will automatically be screened under the following recommendation: "Screening should be implemented upon entry into, and periodically thereafter in, the juvenile justice and child welfare systems, as well as in other settings and populations with known high risk, such as the Medicaid population."
The report also specifically calls for screening programs to be linked to "state-of-the-art treatments" using "specific medications for specific conditions." A fact not mentioned is that 95% of the "specific medications" referred to were not FDA approved for treating children and have never been tested as safe and effective with children.
In addition, recent studies have shown that, although the rise in numbers of patients taking psychiatric drugs has skyrocketed over the past decade, there has been no decrease in mental illness. To the contrary, judging by the company sales figures, the man-made epidemic is still spreading like a wildfire.
But worst of all, for all the money spent and the stream of new serious side effect emerging each year, no patients are recovering from their alleged "mental disorders."
The screening program recommended by Bush's Commission for use in the public school system was TeenScreen, which created a controversy all across the country when the survey began being administered to students without the knowledge or consent of the parents.
TeenScreen claims it can identify several mental disorders. On March 2, 2004, while trying to drum up federal funding at a Congressional hearing, TeenScreen's Executive Director, Laurie Flynn, testified that, in the screening process, "youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality."
Critics disagree. "The TeenScreen program is a fraud," says Dr Lehrman. "It makes 'mental cases' rather than finding them by giving youngsters brain-injuring medicines."
The Citizens Commission for Human Rights points out that "human beings have been bumping and bumbling their way through adolescence for a few hundred thousand years, at least."
"Now TeenScreen and its allies," it says, "want to turn that right of passage into a profit center of psychiatrists and their allied pharmaceutical companies," in the November 2006 report, "TeenScreen: Life Saving Intervention, or Orwellian Nightmares?"
In addition, critics say any label of mental illness will have many life-long adverse effects on these children. They will have problems filling out job applications and applying for insurance when they have to say they were diagnosed mentally ill in childhood.
And this will especially be true for those children who have to reveal that the drugs they were prescribed as a child were atypical antipsychotics used to treat schizophrenia or bipolar disorder leading most people to logically conclude that the person has a life-long mental illness.
The atypicals include Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon, none of which are FDA approved for any use with children and are only approved for treating schizophrenia and manic episodes of bipolar disorder in adults.
Think about it. What do most people think of when they hear the term schizophrenia? Rightly or wrongly, they envision people who are delusional, hear voices, unpredictable and violent. In other words, the person is at least bizarre and at worst dangerous to be around.
And also, there is no denying that such a label results in stigmatism for life, because when do we ever hear that a person "used to have" schizophrenia or bipolar disorder? By design, the drug companies are setting up children to become life-long customers by having them labeled with the most serious of mental disorders.
For nearly 20 years, the drug makers have been raking in profits by promoting the selective serotonin reuptake inhibitor antidepressants (SSRIs) which include Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, as working better than the older drugs and concealing the association between the drugs and suicidality.
"Parents must be better informed," according to a report by The Citizens Commission on Human Rights.
"Few, if any, parents faced with the school situation of their child being labeled as 'mentally ill' or 'learning disordered' and coerced into taking psychiatric drugs, are told that there are many other factors that could be causing the child's inattention, behavior problems or learning difficulties," CCHR states.
"Common causes," the report says, "are poor reading and math skills requiring tutoring, environmental toxins, allergies, nutritional deficiencies, and other easily detectable and treatable physical conditions."
Special medical doctors can do tests to determine if a person is experiencing an allergic reaction, and diet can also help, the report notes.
Critics who have investigated the TeenScreen program say it is being sold to the public by the funneling of millions of industry dollars through front groups posing as patient advocacy groups. "The National Alliance for Mental Illness (NAMI)," Mr Kramer says, "pushes suicide screening of children nationwide and receives millions in drug money."
NAMI received $544,500 from Eli Lilly in the first quarter of this year alone, he notes.
The industry definitely gets a lot of bang for the buck when using NAMI and other front groups. Internationally known expert and author of many books on psychotropic drugs, psychiatrist, Dr Peter Breggin, founder of The International Center for the Study of Psychiatry and Psychology (ICSPP), says groups like NAMI hold national meetings that bring together drug advocates to talk directly to consumers.
"They also send out newsletters and other information that praise the drugs," he says.
"Sometimes," he adds, "they actively suppress viewpoints that are critical of drugs, for example, by discouraging the media from airing opposing viewpoints."
According to Mr Kramer, the TeenScreen advisory board also has major ties to the pharmaceutical industry.
Psychiatrist David Shaffer, who is credited with the development of the TeenScreen survey, is a paid consultant for GlaxoSmithKline on the matter of Paxil and adolescent suicide and has served as an expert witness in lawsuits against plaintiffs injured by pharmaceutical products on behalf of Hoffman la Roche and Wyeth Pharmaceuticals.
In January 2004, Shaffer co-authored a report in the Journal of the American College of Neuropsychopharmacology that claimed, "SSRI antidepressants do not increase the risk of suicidal thinking or suicide attempts in youth."
By design, the report coincided with the scheduled FDA advisory committee hearings on the issue of whether SSRI use was associated with suicidality in children, and all authors but one had extensive ties to the industry. In the end, the panel ignored Shaffer's bogus study and determined that a black box warning should be added to SSRI labels.
A few months later, on December 9, 2004, ABC's Prime Time Live revealed that at least 100 children in the US had committed suicide while taking these new antidepressants and many more had attempted suicide.
The fact that SSRIs cause violence in some people was also concealed by the drug makers for years. As far back as November 2002, Fox News reported that 7 of the 12 teens involved in school shootings were either taking SSRIs or stimulants or were experiencing the withdrawal effects from the drugs and that the possible drug use by the other 5 shooters was unknown at the time because their medical records were sealed. Columbine shooter Eric Harris was on Luvox.
Critics say it's no coincidence that TeenScreen leader Laurie Flynn was the CEO of NAMI for 16 years before she was promoted to head TeenScreen.
Under Flynn, CCHR reports, NAMI became a virtual marketing arm of the industry, stating in its Guidelines for the Relationship between NAMI and the Campaign's Founding Sponsors: "Providers, health plans, and pharmaceutical companies want to grow their markets and to increase their share of the market...NAMI will cooperate with these entities to grow the market by making persons aware of the issues involving severe brain disorders...and by helping persons to adhere to their treatment plans."
An Indiana mother, Teresa Rhodes, has created an online petition against TeenScreen after her 15-year-old daughter, Chelsea, was screened at school without parental consent and was falsely labeled with not one but 2 mental illnesses, obsessive-compulsive disorder and social anxiety disorder. People wishing to sign the petition can do so by clicking on this link http://www.petitiononline.com/TScreen/petition.html.
Mr Kramer says the petition is an excellent way to educate people about TeenScreen because it conveys many of the facts about mental health screening and can be printed off and presented to school board members and local, state and federal legislators.
Activist Vince Boehm has been advocating against screening and the drugging of children for more years than he would like to count. However, he got especially upset recently while watching a discussion on TV about the positive business outlook for the sale of psychiatric drugs to children.
"I was listening to the Bloomberg Business Channel recently," he says, "and caught an interview with a drug company sales executive."
"He was talking about how his market share for psychiatric drugs was booming in the pediatric market," he recalled.
"Then I thought about the children," Vince said and screamed at the TV, "You jackass! (I actually used a somewhat stronger expletive), these are not 'market shares' they are kids!"
According to Laurie Yorke, "Pandora's Box is an understatement when it comes to mental health screening."
Laurie is a Registered Nurse whose son was labeled mentally ill and prescribed Paxil and experienced a severe withdrawal syndrome when he stopped taking the drug.
"I think one thing that is never mentioned with TeenScreen," she states, "is how is the school going to handle a child who has been labeled?"
"What if a child is diagnosed with an 'anxiety disorder,' she points out. "Is the school prepared to provide home instruction, smaller classrooms, or whatever is required to educate that child?"
"I bring this up," she notes, "because Ryan's school denied his withdrawal from Paxil, accused me of 'working the system' and attacked my reputation to all who would listen and finally withdrew his home instruction."
As a result, Laurie says, her son withdrew from high school altogether. "If this is how they treat someone who is 'labeled,'" she asks, "how are they going to provide an education for all of those who are being labeled because of TeenScreen?"
In addition, she points out, "how are they going to handle all the children suffering from adverse effects from a drug that they have been prescribed as a result of TeenScreen?"
On May 17, 2007, Laurie testified at a hearing in support of a New Jersey legislative bill that requires physicians and other prescribers to obtain informed consent from parents or guardians of minors who are prescribed psychotropic medication with "black box warnings," to include informing the parent or guardian of all the potential adverse events associated with the drug.
The bill specifies that a physician or other authorized prescriber who prescribes a medication in violation of this act shall be subject to disciplinary action by the State Board of Medical Examiners. The bill was approved by the State Assembly's Consumer Affairs Committee.
Before allowing children to take SSRIs, Mr Kramer recommends that at the very least, everyone should get educated on the black box warning which states: "Antidepressants increase the risk of suicidal thinking and behavior in children and adolescents."
"This FDA warning alone," he notes, "should be a wake-up call for any true suicide prevention effort."
The Alliance for Human Research Protection is taking activism a step further by kicking off a campaign urging restrictions on off-label use of all drugs that carry black box warnings.
"Inasmuch as these drugs are deemed by the FDA to carry life-threatening risks of harm," says AHRP director Vera Hassner Sharav, "their use should be restricted and off-label prescribing of these drugs should be off-limits!"
Bush's plan for screening the nation's roughly 36 million senior citizens is set up through the "Positive Aging Act of 2005." The Act provides federal tax dollars for community-based outreach teams to hunt down the elderly wherever they can be found whether it be at senior citizen centers, adult day care programs, or assisted living facilities.
Thursday, August 5, 2010
Zyprexa Sales Show No Amount of Lawsuits Will Deter Lilly
Evelyn Pringle September 28, 2006
Scores of new lawsuits are being filed by patients who say they took Zyprexa without knowing the risks after Eli Lilly promoted the drug to doctors as a treatment for conditions other than schizophrenia and bipolar disorder that the drug is approved to treat.
In June 2005, Lilly announced plans to settle roughly 8,000 claims by patients alleging the development of diabetes due to the use of Zyprexa. In an unusually early settlement, Lilly settled the cases for $690 million after only five plaintiffs had provided depositions and before any substantive depositions had been taken from the Lilly defendants.
However, it appears that no amount of lawsuits are going to deter Lilly from promoting the off-label sales of Zyprexa. According to Lilly's latest SEC filing, sales of Zyprexa in the second quarter of 2006 totaled $1.12 billion, a 2% increase over the second quarter of 2005.
Lilly noted in the filing that US sales fell 1% due to a lower demand, but said the company made up for the lower sales by charging a higher price for the drug.
Zyprexa has been approved for treatment of adults with a limited number of conditions. However, although a drug can only be marketed for specific indications approved by the FDA, federal law allows doctors to prescribe a drug for any use regardless of whether its approved for that indication or not.
This loophole has led to Zyprexa being prescribed to treat disorders for which the drug is not approved and for mild psychological disorders for which the drug was never intended.
Critics say this policy must be changed in order to prevent serious health problems in patients who believe the drugs they take are approved and safe merely because a doctor has prescribed them.
Legal experts say it will not take a legal genius to get juries to understand the simple logic that Zyprexa sales would be down, not rising, if Lilly had indeed stopped over-promoting the drug for off-label uses.
Thousands of new lawsuit have been filed since last year's settlement of the first batch of claims. According to Bloomberg News on April 20, 2006, as many as 5,000 new suits have been filed in state and federal courts and more are expected, say attorneys for patients in California, Pennsylvania, Mississippi and Texas.
Patrick Mulligan, a Dallas personal-injury attorney, told Bloomberg that he filed 2,500 Zyprexa suits in state courts after the settlement, primarily in California and Indiana.
And a Zyprexa case filed in Texarkana, Texas, in March 2006, by another law firm involves 492 individuals.
But yet critics say the off-label prescribing continues. "Doctors are prescribing it for women with post-partum depression; they're prescribing it for children who are acting out," said Tommy Fibich, a Houston attorney representing 300 patients to Bloomberg News.
The allegations involving children could be more costly to resolve, according to Robert Rabin, a Stanford University law professor who specializes in product-defect litigation. "Kids are a particularly vulnerable group of plaintiffs," Mr Rabin told Bloomberg.
If the claims involving children can be proven, the damages would be higher, he says, because they would need to be paid over a longer period of time
According to Dr Stefan Kruszewski, MD, a Harvard trained, board certified psychiatrist in adult, adolescent, geriatric and addiction psychiatry, from Harrisburg, Pennsylvania, the new antipsychotics increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke.
Like most other critics, he also says that Lilly knew about these side effects long before the drug company issued any warnings to doctors and consumers.
"Zyprexa and its antipsychotics counterparts," Dr Kruszewski explains, "were marketed to be safer and easier to tolerate than the older, cheaper antipsychotics because the pharmaceutical companies said that the newer drugs caused fewer neurological injuries, like restlessness or 'akathesia,' and tardive dyskinesia."
Those claims have turned out to be totally false he says. "So, what we have now is a drug, Zyprexa, whose massive revenues and promotion are based upon faulty disclosures by the manufacturer, Eli Lilly," he advises.
"The drug causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," he explains, "at the same time that it continues to cause neurological side-effects like the older antipsychotics."
It does have a major advantage for Lilly, he points out, because a dose of older antipsychotic haloperidol might sell for 6 pennies while a dose of Zyprexa might sell for over 6 dollars.
Using fraud, kickback and antitrust statutes, state attorneys general have filed legal actions against Lilly to recover the money paid out for Zyprexa by government funded programs like Medicaid.
According to the October 23, 2005, San Francisco Chronicle, "Nationwide, Medicaid programs purchase an estimated 60 to 75 percent of antipsychotic drugs."
Zyprexa holds the title of top money maker for Lilly when it comes to state funded healthcare programs. For instance, Zyprexa was the highest expenditure for Medi-Cal, California's version of Medicaid, at close to $250 million in the year ending in June 2005.
Private health care programs also want their money back. A lawsuit filed in New York in August 2004, on behalf of private health insurers accuses Lilly of violating racketeering laws, in part, by bankrolling nonprofit groups to promote Zyprexa as a treatment for a number of unapproved conditions and to downplay the medicine's side effects.
Proof of this allegation can be found in Kentucky. In 2002, the Kentucky Medicaid program had a $230 million deficit, and a $36 million bill for Zyprexa was the largest drug expense.
When Kentucky held public hearings and tried to exclude Zyprexa from Medicaid's list of preferred drugs, the most notorious pharma front group in the US, the National Alliance for the Mentally Ill (NAMI), bused in protesters to the hearings, placed full-page ads in newspapers, and sent faxes to state officials. However, what NAMI did not reveal at the time was that the buses, ads, and faxes were paid for by Eli Lilly, according to the December 18, 2003 New York Times.
NAMI also came out in full force to discredit a study by the National Institute of Mental Health, the largest and longest independent study on the new antipsychotics to date, called the Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE. The results of the study released in September 2005, said the new atypical antipsychotics "have no substantial advantage" over the old ones.
The minute the CATIE results were made public, the NAMI army was disbursed to protect the profits of the new drugs. First, NAMI blamed the results of the study on patients who participated. Many patients dropped out or discontinued the medication, NAMI said, because they suffered from a co-occurring disorder called anosognosia, or "lack of insight" into the need for treatment.
Next it complained about the fact that the CATIE study "only lasted for 18 months," although critics point out that NAMI has never been heard to complain when a drug company trial lasted a mere 12 weeks or less.
It in fact, critics say, it will not be difficult to prove that all the major drug companies pay big money to these front groups to do their bidding. For instance, in a March 9, 2005, Press Release, the Health and Social Campaigners' Network International, revealed a survey of annual reports from "patient advocacy groups" that showed an escalation in pharma donations, but for market-driven reasons.
The survey looked at the top 12 donors (Pfizer; GSK; AstraZeneca; Johnson & Johnson; Merck; Novartis; Aventis; Roche; Lilly; Bristol-Myers; Wyeth; and Abbott), plus the types of health-based charities to which the companies gave their money and found that in almost 100% of cases, the drug makers gave money to the groups that specialize in the therapeutic areas in which the drug companies research, develop or market products.
Overall, the report said, pharma funding can account for more than half of the revenue received by these groups, and yet only four of the 125 annual reports contained information about the specific amounts of money provided by drug companies.
"Not surprisingly, the report noted, "these details were almost entirely absent from most of the reports."
Another lawsuit filed by the attorney general of Mississippi in July 2006, charges that Lilly knew Zyprexa increased the risk of diabetes, pointing out that in April, 2002, nearly a year and a half before Lilly first warned doctors and consumers of the risk of diabetes in the US, the company changed the drug's labeling in the UK and Japan to include warnings about the association between Zyprexa and diabetes related injuries.
According to the attorney general's office, about 10% of Zyprexa patients have developed insulin-dependent diabetes. Some of these patients are children, the lawsuit says, even though Zyprexa "has never been approved for, nor found to be effective, in the treatment of children."
Nonetheless, Lilly has doctors prescribing Medicaid funded Zyprexa to kids all over the country. For instance, a study in the August 3, 2004 Archives of Pediatric Adolescent Medicine, found the number of children in Tennessee covered by the state's TennCare program, who were prescribed antipsychotics nearly doubled in six years. The largest increases were among children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12. The study also found a 61% increase in use with preschool children.
In Texas, a review of prescriptions for the months of July and August 2004, found that more than 19,400 teenagers were prescribed an antipsychotic billed to a publicly funded program, according to ACS-Heritage, a medical consulting firm hired by the state to investigate the use of psychotropic drugs on children.
Nearly 98% of the teens, ACS said, were prescribed antipsychotics "off-label" for conditions not approved and in more than half of the cases, the dosage appeared to be inappropriately high.
The study also said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drug, and one-third of the children were on 2 or more drugs.
Experts point out that Zyprexa is not only dangerous to use with children, the drug has been shown to be less effective in treating children than the older cheaper class of antipsychotics. The results of a study published in August 2006, by the New York Psychiatric Institute, found that the older antipsychotics worked much better with kids.
According to the study, the average response rate in children among 8 studies employing the new antipsychotics was only 55.7%, compared to a 72.3% response rate among children in 13 studies who were given the older drugs.
In February 2006, Alaska and West Virginia filed lawsuits against Lilly alleging the company improperly marketed the drug for unapproved uses and cost the states millions of dollars after patients developed diabetes and other diseases.
West Virginia is seeking payment for all medical costs related to Zyprexa, in addition to reimbursement for the more than $70 million the state paid for the drug. The state maintains that damages can be tripled under the law cited in the complaint.
The lawsuit says studies have linked Zyprexa to diabetes since 1998, and that sales representatives misled and deceived doctors about the safety and the efficacy of Zyprexa and that Lilly's advertisements deceptively understated risks and overstated benefits.
The complaint alleges that Lilly promoted "off label" prescriptions for a host of conditions including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, the complaint says, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.
"Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs," the complaint states.
Two additional federal class actions were filed against Lilly on February 28, 2006 in New York. One asks for reimbursement for all money paid by consumers and non-government health plans and the other demands medical monitoring of all people who took Zyprexa who have not yet been diagnosed with diabetes, pancreatitis or high blood sugar.
There is no doubt that both the FDA and Lilly knew about these risks long before they alerted doctors and consumers. In a study published in the July 2002 journal Pharmacotherapy, P Murali Doraiswamy, the chief of biological psychiatry at Duke University, reviewed the FDA adverse event reports submitted on Zyprexa patients and found that of the 289 cases of diabetes, 225 patients were newly diagnosed.
In addition, the review showed that 100 patients developed ketosis, a serious complication of diabetes, and 22 people developed pancreatitis, or inflammation of the pancreas that is life-threatening. There were also 23 deaths, including a 15-year-old patient who died of necrotizing pancreatitis.
Lilly has also been hit with Zyprexa lawsuits in Canada. According to company's latest SEC filing, in 2005 the drug maker was served with four lawsuits seeking class action status in Canada on behalf of patients who took Zyprexa, and one of the lawsuits has been certified for residents of Quebec.
"The allegations in the Canadian actions," the filing states, "are similar to those in the litigation pending in the United States."
Also in Canada, according to an August 30, 2006 article in Monday, Victoria health researcher Janet Currie, is calling for a public inquiry into the use of the atypical antipsychotic drugs. The drugs are being prescribed for the wrong reasons to seniors and children, says Ms Currie, the director of the Victoria-based Psychiatric Medication Awareness Group.
"Atypical anti-psychotics are only supposed to be prescribed for schizophrenia and psychosis," she states. "Yet they're being used for sedation and behaviour control."
Ms Currie says she is "absolutely" sure that Zyprexa is being given to children and seniors when it should not be. "It's being prescribed way, way beyond the indicated uses of schizophrenia and psychosis," she says.
Zyprexa is covered by the government funded PharmaCare program. According to BC health ministry data, PharmaCare paid $26,493,119 in 2005 for Zyprexa, $11,688,886 for risperidone (which is sold as Risperdal), and $13,279,737 for quetiapine fumarate (sold under the name Seroquel).
Ms Currie says those figures suggest the drugs are being over prescribed particularly in light of serious side-effects they cause. She reported that one woman had gained more than 100 pounds. "Weight gain exposes you to all sorts of other problems," she says.
According to the Monday article, a special authority drug is one that may only be prescribed under special criteria. In the case of Zyprexa, the patient must have been diagnosed with schizophrenia or other non-dementia-related psychosis and other antipsychotic drugs must have failed, or not been tolerated by the patient.
Ms Currie claims that PharmaCare's controls on "special authority" drugs like Zyprexa are "useless."
"It has no teeth in it at all," she says. "It's not working."
She claims that drug companies are only interested is profits. "They don't care about the damage that may lie in their wake, to individuals, to the family and to the health care system," she says. "It's like a mining company that comes in, rips up a mountain and then walks off."
Scores of new lawsuits are being filed by patients who say they took Zyprexa without knowing the risks after Eli Lilly promoted the drug to doctors as a treatment for conditions other than schizophrenia and bipolar disorder that the drug is approved to treat.
In June 2005, Lilly announced plans to settle roughly 8,000 claims by patients alleging the development of diabetes due to the use of Zyprexa. In an unusually early settlement, Lilly settled the cases for $690 million after only five plaintiffs had provided depositions and before any substantive depositions had been taken from the Lilly defendants.
However, it appears that no amount of lawsuits are going to deter Lilly from promoting the off-label sales of Zyprexa. According to Lilly's latest SEC filing, sales of Zyprexa in the second quarter of 2006 totaled $1.12 billion, a 2% increase over the second quarter of 2005.
Lilly noted in the filing that US sales fell 1% due to a lower demand, but said the company made up for the lower sales by charging a higher price for the drug.
Zyprexa has been approved for treatment of adults with a limited number of conditions. However, although a drug can only be marketed for specific indications approved by the FDA, federal law allows doctors to prescribe a drug for any use regardless of whether its approved for that indication or not.
This loophole has led to Zyprexa being prescribed to treat disorders for which the drug is not approved and for mild psychological disorders for which the drug was never intended.
Critics say this policy must be changed in order to prevent serious health problems in patients who believe the drugs they take are approved and safe merely because a doctor has prescribed them.
Legal experts say it will not take a legal genius to get juries to understand the simple logic that Zyprexa sales would be down, not rising, if Lilly had indeed stopped over-promoting the drug for off-label uses.
Thousands of new lawsuit have been filed since last year's settlement of the first batch of claims. According to Bloomberg News on April 20, 2006, as many as 5,000 new suits have been filed in state and federal courts and more are expected, say attorneys for patients in California, Pennsylvania, Mississippi and Texas.
Patrick Mulligan, a Dallas personal-injury attorney, told Bloomberg that he filed 2,500 Zyprexa suits in state courts after the settlement, primarily in California and Indiana.
And a Zyprexa case filed in Texarkana, Texas, in March 2006, by another law firm involves 492 individuals.
But yet critics say the off-label prescribing continues. "Doctors are prescribing it for women with post-partum depression; they're prescribing it for children who are acting out," said Tommy Fibich, a Houston attorney representing 300 patients to Bloomberg News.
The allegations involving children could be more costly to resolve, according to Robert Rabin, a Stanford University law professor who specializes in product-defect litigation. "Kids are a particularly vulnerable group of plaintiffs," Mr Rabin told Bloomberg.
If the claims involving children can be proven, the damages would be higher, he says, because they would need to be paid over a longer period of time
According to Dr Stefan Kruszewski, MD, a Harvard trained, board certified psychiatrist in adult, adolescent, geriatric and addiction psychiatry, from Harrisburg, Pennsylvania, the new antipsychotics increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke.
Like most other critics, he also says that Lilly knew about these side effects long before the drug company issued any warnings to doctors and consumers.
"Zyprexa and its antipsychotics counterparts," Dr Kruszewski explains, "were marketed to be safer and easier to tolerate than the older, cheaper antipsychotics because the pharmaceutical companies said that the newer drugs caused fewer neurological injuries, like restlessness or 'akathesia,' and tardive dyskinesia."
Those claims have turned out to be totally false he says. "So, what we have now is a drug, Zyprexa, whose massive revenues and promotion are based upon faulty disclosures by the manufacturer, Eli Lilly," he advises.
"The drug causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," he explains, "at the same time that it continues to cause neurological side-effects like the older antipsychotics."
It does have a major advantage for Lilly, he points out, because a dose of older antipsychotic haloperidol might sell for 6 pennies while a dose of Zyprexa might sell for over 6 dollars.
Using fraud, kickback and antitrust statutes, state attorneys general have filed legal actions against Lilly to recover the money paid out for Zyprexa by government funded programs like Medicaid.
According to the October 23, 2005, San Francisco Chronicle, "Nationwide, Medicaid programs purchase an estimated 60 to 75 percent of antipsychotic drugs."
Zyprexa holds the title of top money maker for Lilly when it comes to state funded healthcare programs. For instance, Zyprexa was the highest expenditure for Medi-Cal, California's version of Medicaid, at close to $250 million in the year ending in June 2005.
Private health care programs also want their money back. A lawsuit filed in New York in August 2004, on behalf of private health insurers accuses Lilly of violating racketeering laws, in part, by bankrolling nonprofit groups to promote Zyprexa as a treatment for a number of unapproved conditions and to downplay the medicine's side effects.
Proof of this allegation can be found in Kentucky. In 2002, the Kentucky Medicaid program had a $230 million deficit, and a $36 million bill for Zyprexa was the largest drug expense.
When Kentucky held public hearings and tried to exclude Zyprexa from Medicaid's list of preferred drugs, the most notorious pharma front group in the US, the National Alliance for the Mentally Ill (NAMI), bused in protesters to the hearings, placed full-page ads in newspapers, and sent faxes to state officials. However, what NAMI did not reveal at the time was that the buses, ads, and faxes were paid for by Eli Lilly, according to the December 18, 2003 New York Times.
NAMI also came out in full force to discredit a study by the National Institute of Mental Health, the largest and longest independent study on the new antipsychotics to date, called the Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE. The results of the study released in September 2005, said the new atypical antipsychotics "have no substantial advantage" over the old ones.
The minute the CATIE results were made public, the NAMI army was disbursed to protect the profits of the new drugs. First, NAMI blamed the results of the study on patients who participated. Many patients dropped out or discontinued the medication, NAMI said, because they suffered from a co-occurring disorder called anosognosia, or "lack of insight" into the need for treatment.
Next it complained about the fact that the CATIE study "only lasted for 18 months," although critics point out that NAMI has never been heard to complain when a drug company trial lasted a mere 12 weeks or less.
It in fact, critics say, it will not be difficult to prove that all the major drug companies pay big money to these front groups to do their bidding. For instance, in a March 9, 2005, Press Release, the Health and Social Campaigners' Network International, revealed a survey of annual reports from "patient advocacy groups" that showed an escalation in pharma donations, but for market-driven reasons.
The survey looked at the top 12 donors (Pfizer; GSK; AstraZeneca; Johnson & Johnson; Merck; Novartis; Aventis; Roche; Lilly; Bristol-Myers; Wyeth; and Abbott), plus the types of health-based charities to which the companies gave their money and found that in almost 100% of cases, the drug makers gave money to the groups that specialize in the therapeutic areas in which the drug companies research, develop or market products.
Overall, the report said, pharma funding can account for more than half of the revenue received by these groups, and yet only four of the 125 annual reports contained information about the specific amounts of money provided by drug companies.
"Not surprisingly, the report noted, "these details were almost entirely absent from most of the reports."
Another lawsuit filed by the attorney general of Mississippi in July 2006, charges that Lilly knew Zyprexa increased the risk of diabetes, pointing out that in April, 2002, nearly a year and a half before Lilly first warned doctors and consumers of the risk of diabetes in the US, the company changed the drug's labeling in the UK and Japan to include warnings about the association between Zyprexa and diabetes related injuries.
According to the attorney general's office, about 10% of Zyprexa patients have developed insulin-dependent diabetes. Some of these patients are children, the lawsuit says, even though Zyprexa "has never been approved for, nor found to be effective, in the treatment of children."
Nonetheless, Lilly has doctors prescribing Medicaid funded Zyprexa to kids all over the country. For instance, a study in the August 3, 2004 Archives of Pediatric Adolescent Medicine, found the number of children in Tennessee covered by the state's TennCare program, who were prescribed antipsychotics nearly doubled in six years. The largest increases were among children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12. The study also found a 61% increase in use with preschool children.
In Texas, a review of prescriptions for the months of July and August 2004, found that more than 19,400 teenagers were prescribed an antipsychotic billed to a publicly funded program, according to ACS-Heritage, a medical consulting firm hired by the state to investigate the use of psychotropic drugs on children.
Nearly 98% of the teens, ACS said, were prescribed antipsychotics "off-label" for conditions not approved and in more than half of the cases, the dosage appeared to be inappropriately high.
The study also said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drug, and one-third of the children were on 2 or more drugs.
Experts point out that Zyprexa is not only dangerous to use with children, the drug has been shown to be less effective in treating children than the older cheaper class of antipsychotics. The results of a study published in August 2006, by the New York Psychiatric Institute, found that the older antipsychotics worked much better with kids.
According to the study, the average response rate in children among 8 studies employing the new antipsychotics was only 55.7%, compared to a 72.3% response rate among children in 13 studies who were given the older drugs.
In February 2006, Alaska and West Virginia filed lawsuits against Lilly alleging the company improperly marketed the drug for unapproved uses and cost the states millions of dollars after patients developed diabetes and other diseases.
West Virginia is seeking payment for all medical costs related to Zyprexa, in addition to reimbursement for the more than $70 million the state paid for the drug. The state maintains that damages can be tripled under the law cited in the complaint.
The lawsuit says studies have linked Zyprexa to diabetes since 1998, and that sales representatives misled and deceived doctors about the safety and the efficacy of Zyprexa and that Lilly's advertisements deceptively understated risks and overstated benefits.
The complaint alleges that Lilly promoted "off label" prescriptions for a host of conditions including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, the complaint says, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.
"Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs," the complaint states.
Two additional federal class actions were filed against Lilly on February 28, 2006 in New York. One asks for reimbursement for all money paid by consumers and non-government health plans and the other demands medical monitoring of all people who took Zyprexa who have not yet been diagnosed with diabetes, pancreatitis or high blood sugar.
There is no doubt that both the FDA and Lilly knew about these risks long before they alerted doctors and consumers. In a study published in the July 2002 journal Pharmacotherapy, P Murali Doraiswamy, the chief of biological psychiatry at Duke University, reviewed the FDA adverse event reports submitted on Zyprexa patients and found that of the 289 cases of diabetes, 225 patients were newly diagnosed.
In addition, the review showed that 100 patients developed ketosis, a serious complication of diabetes, and 22 people developed pancreatitis, or inflammation of the pancreas that is life-threatening. There were also 23 deaths, including a 15-year-old patient who died of necrotizing pancreatitis.
Lilly has also been hit with Zyprexa lawsuits in Canada. According to company's latest SEC filing, in 2005 the drug maker was served with four lawsuits seeking class action status in Canada on behalf of patients who took Zyprexa, and one of the lawsuits has been certified for residents of Quebec.
"The allegations in the Canadian actions," the filing states, "are similar to those in the litigation pending in the United States."
Also in Canada, according to an August 30, 2006 article in Monday, Victoria health researcher Janet Currie, is calling for a public inquiry into the use of the atypical antipsychotic drugs. The drugs are being prescribed for the wrong reasons to seniors and children, says Ms Currie, the director of the Victoria-based Psychiatric Medication Awareness Group.
"Atypical anti-psychotics are only supposed to be prescribed for schizophrenia and psychosis," she states. "Yet they're being used for sedation and behaviour control."
Ms Currie says she is "absolutely" sure that Zyprexa is being given to children and seniors when it should not be. "It's being prescribed way, way beyond the indicated uses of schizophrenia and psychosis," she says.
Zyprexa is covered by the government funded PharmaCare program. According to BC health ministry data, PharmaCare paid $26,493,119 in 2005 for Zyprexa, $11,688,886 for risperidone (which is sold as Risperdal), and $13,279,737 for quetiapine fumarate (sold under the name Seroquel).
Ms Currie says those figures suggest the drugs are being over prescribed particularly in light of serious side-effects they cause. She reported that one woman had gained more than 100 pounds. "Weight gain exposes you to all sorts of other problems," she says.
According to the Monday article, a special authority drug is one that may only be prescribed under special criteria. In the case of Zyprexa, the patient must have been diagnosed with schizophrenia or other non-dementia-related psychosis and other antipsychotic drugs must have failed, or not been tolerated by the patient.
Ms Currie claims that PharmaCare's controls on "special authority" drugs like Zyprexa are "useless."
"It has no teeth in it at all," she says. "It's not working."
She claims that drug companies are only interested is profits. "They don't care about the damage that may lie in their wake, to individuals, to the family and to the health care system," she says. "It's like a mining company that comes in, rips up a mountain and then walks off."
Subscribe to:
Comments (Atom)