The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

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.”

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, front groups, Kifuji, NAMI, NFC, Spitzer, SSRIs, TeenScreen

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 http://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.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, front groups, NAMI, NFC, Spitzer, SSRIs, TeenScreen

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.

Filed under: 2007, drugging children, front groups, NAMI, NFC, TeenScreen, TMAP

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.”

Filed under: 2006, antipsychotics, drugging children, Eli Lilly, front groups, MEDICAID, NAMI, PPD, Zyprexa

Drug Companies Still Peddling Risperdal and Zyprexa For Off-Label Use

Evelyn Pringle June 17, 2006

According to Kelly O’Meara, author of the newly released book, Psyched Out, America has a drug problem. “It’s not as covert as those illicit and illegal “Just Say No” drugs,” she says, “but, rather, Americans have become drug users by way of being diagnosed as suffering from one or a number of alleged mental disorders.”

“Sharing one’s feelings with a doctor,” she warns, “more often than not is all it takes to be diagnosed with a psychiatric disorder and prescribed a mind-altering drug to “treat” the disorder.”

According to O’Meara, “scattered data from a variety of sources provide a shocking glimpse at not only the direction the drugging of America is heading, but also,” she says, “the number of Americans being labeled as mentally ill.”

One of the top classes of over-prescribed drugs are the new generation of atypicals antipsychotics that were adopted because of claims by drug makers that they were safer, more effective and produced fewer side effects than the older antipsychotics.

However, over the past several years, drug companies have been forced to admit to misleading the FDA, physicians, and consumers about the deadly side effects associated with these drugs including an increased risk of suicide.

According to Harvard trained psychiatrist, Dr Stefan Kruszewski, “the new generation of antipsychotics substantially increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke.”

“The drug causes both a severe metabolic syndrome and cardiovascular problems,” he explains, “at the same time that they continue to cause neurological side effects like the older typical antipsychotics.”

Dr Kruszewski says the drug makers knew of many of these side effects but withheld the data from the FDA. “So, what we have now are drugs,” he advises, “whose massive revenues and promotion are based upon faulty disclosures by the manufacturers.”

The new drugs are far more expensive than the older antipsychotics. “A dose of haloperidol” Dr Kruszewski notes, “might sell for 6 pennies while Zyprexa might sell for over $6 per pill.”

Data unveiled March 2006 by investment firm CIBC World Markets verifies the massive amount of spending going for these drugs. CIBC found that in the previous 12 months, of the top 20 drugs by managed care spending, psychotropic drugs accounted for nearly 20%, or $13 billion. The drugs that made the list were Zyprexa ($2.6 billlion), Seroquel ($2.5 billion), Risperdal ($2.2 billion).

Atypicals were approved by the FDA for treatment of adult schizophrenia and bipolar disorder. None of the 6 drugs including Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon are approved for the treatment of any other disorder in children or the elderly.

But nonetheless, they are being routinely prescribed to patients of all ages, in most cases off-label for uses not approved by the FDA and people are dying from their side effects at alarming rates.

Allen Jones, former investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations says: “My best effort at correlating dollars spent with deaths from drug side effects suggests that people may be dying from side effects from the schizophrenia drugs alone at the rate of at least one death for each one million dollars spent on these drugs.”

Persons on atypicals have been found to commit suicide two to five times more frequently than the schizophrenic population in general. According to award winning author, Bob Whitaker, “researchers in Ireland reported in 2003 that since the introduction of the atypical antipsychotics, the death rate among people with schizophrenia has doubled.”

In an August 2005 interview with Street Spirit, Whitaker said: “They have done death rates of people treated with standard neuroleptics and then they compare that with death rates of people treated with atypical antipsychotics, and it doubles.”

“In fact,” he said, “in their seven-year study, 25 of the 72 patients died.”

Adult onset of diabetes has been found to occur 10 years earlier than usual and in far greater frequency in persons treated with atypicals. In February 2004, the American Association of Clinical Endocrinologists, the American Diabetes Association, the American Psychiatric Association, and the North American Association for the Study of Obesity issued a joint statement warning of the association between Zyprexa and diabetes.

Back in 2002, P Murali Doraiswamy, chief of biological psychiatry at Duke University, reviewed the FDA adverse events reported by Zyprexa patients and found: Of the 289 cases of diabetes linked to Zyprexa, 225 were newly diagnosed cases. One hundred patients developed ketosis (serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life-threatening condition. There were 23 deaths, including that of a 15-year-old who died of necrotizing pancreatitis, according to the paper in the July 2002 journal Pharmacotherapy.

The less popular atypical, Clozaril, approved by the FDA on April 28, 1997 and manufactured by Novartis Pharmaceuticals has been linked to pancreatis, diabetes, and hyperglycemia by researchers at Duke University and the FDA in the January 2005 issue of the Journal of the American Medical Association.

According to a paper in the April 2006 American Journal of Psychiatry, Clozaril’s potential side effects include a loss of disease-fighting white blood cells and a potentially fatal inflammation of heart muscle.

The Journal of Clinical Psychiatry reported that the FDA was made aware of more than 140 new-onset cases of diabetes in patients on Clozaril, and three dozen cases involved ketoacidosis, a sometimes deadly complication of high blood sugar levels.

Elderly patients on atypicals are falling victim to strokes. When atypicals arrived on the market, Big Pharma widely promoted their off-label use to doctors who treat elderly patients. In 1999 the FDA cited Johnson & Johnson for downplaying Risperdal’s risks to elderly patients and making false and misleading claims that in addition to schizophrenia, it could be used “for psychotic symptoms associated with a broad range of disorders.”

Despite the FDA’s warning, Risperdal quickly became a leading off-label treatment for dementia and Alzheimer’s disease. In fact, in 2002, about 670,000 such prescriptions were written for Risperdal use in elderly patients, up more than 350% from 1998, according to a Knight Ridder analysis reported on November 2, 2003.

Although in April 2003, J&J sent a letter to doctors warning of the increase in strokes associated with the drug when prescribed to elderly patients, the warning took two more years to reach the public and came 6 months after public health officials in Canada issued a warning and urged doctors to reconsider their use of the drug to treat dementia.

In April 2005, the FDA warned that the atypicals have been linked to deaths from heart failure and pneumonia in elderly dementia patients and instructed drug makers to revise their drug labels to include strong warnings of the increased risk of death.

Six months later, on October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia-related aggression and delusions can raise their risk of death.

The researchers in the study pooled the results of 15 previous studies on atypicals Zyprexa, Risperdal, Seroquel and Abilify. Among more than 5,000 elderly dementia patients, those taking any of the 4 drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.

According to the AP article, there were 118 deaths among the 3,353 atypical users versus 40 in the 1,757 patients receiving a placebo and the risks were similar for each atypical.

And yet, research shows that nursing home residents are being fed antipsychotics in record numbers. A study published in the June 13, 2005 Archives of Internal Medicine examined the quality of antipsychotic prescriptions in about 2.5 million Medicaid patients in nursing homes and found that “over half (58.2%),” received antipsychotics that exceeded the maximum recommended dosage, received duplicate therapy, or under the guidelines, had inappropriate indications for the medications to begin with.

The study determined that more than 200,000 nursing home residents received antipsychotic therapy but had “no appropriate indications for use.”

A USA Today analysis of FDA data determined that at least 45 children died from 2000 to 2004 with an atypical listed as the “primary suspect.” In addition, more than 1,300 cases of serious side effects were reported, including some known be life threatening, such a low white blood cell count and convulsions.

According to an analysis of a federal survey by researchers at Vanderbilt Medical School in Nashville, outpatient prescriptions for children between the of 2 and 18 increased about fivefold from under 500,000 in 1995 to about 2.5 million in 2002.

One of the most disturbing, dangerous trends linked to atypicals, USA says is called “polypharmacy”: routinely giving kids several psychiatric drugs. According to child psychiatrist Joseph Penn of Bradley Hospital and Brown University School of Medicine in Providence, “We know very little about the interaction of these drugs, the effects they could be having on kids.”

Penn told USA that he is appalled at how many times he has seen the mega-powerful atypicals prescribed to children suffering from insomnia when they’re taking other medicines.

“I’ve seen hundreds of cases,” he says, “and often parents don’t seem to have been told about the many less risky prescription and non-prescription options out there.”

Kids of all ages are being fed these dangerous drugs in states all across the country. A study directed by Oregon Health & Science University professor David Pollack, found 246 preschool children covered by the Oregon Health Plan receiving antipsychotic or antidepressant drugs. The study, in Oregon Health News, reviewed Medicaid records and found that 41% of the children were given the drugs for attention deficit disorder.

The Children’s Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with drugs like Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify, according to Robert F. Kennedy Jr vs the Medical Elite, by Mark Sircus Ac, OMD in June 22, 2005.

In February 2006, Florida’s public health officials ordered an independent investigation into why the number of children on Medicaid in that state taking antipsychotics has nearly doubled over the past five years from 9,500 to almost 18,000.

A new study published in the June 2006 Archives of General Psychiatry analyzed data from a national survey of doctors’ office visits and found that antipsychotics were prescribed to 1,438 per 100,000 children and adolescents in 2002, up from 275 per 100,000 in the two-year period from 1993 to 1995, according to the June 6, 2006 New York Times.

The researchers determined that about a third of the children on antipsychotics were diagnosed with behavior disorders, including attention deficit problems; a third had psychotic symptoms or developmental problems; and another third were diagnosed with mood disorders. Over all, more than 40% of the children were also taking at least one other psychiatric medication.

“If you’re going to put children on three or four different drugs, now you’ve got a potpourri of target symptoms and side effects,” Dr Julie Magno Zito, an associate professor of pharmacy and medicine at the University of Maryland told the Times.

“How do you even know who the kid is anymore?” Dr Zito noted.

However, Big Pharma’s long arm could not reach the nation’s children if not for their creative promotional schemes. Industry-backed front groups like the National Alliance of Mental Illness and TeenScreen are working overtime to get as many kids as possible hooked into long term drug treatment under the ruse of suicide prevention through mandatory screening of the 52 million students in the nation’s public school system to turn kids into consumers before they leave high school.

The gang behind TeenScreen, claims the survey can detect seven mental health disorders. The program’s Executive Director, Laurie Flynn, told a congressional committee on March 2, 2004, 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 are outraged over TeenScreen. “The goal is to promote the patently false idea that we have a nation of children with undiagnosed mental disorders crying out for treatment,” according to Forcing Kids Into a Mental Health Ghetto, by Texas Congressman and physician, Ron Paul.

Former Medicaid program investigator, Allen Jones says, “the mandatory screening of all students, with follow-up treatment as required, translates into putting more kids on mind-altering and potentially lethal drugs.”

On June 16, 2006 the Washington Post said, the use “of the psychological evaluations is growing even though there is little hard evidence that they prevent suicides.”

TeenScreen was set up to sell dangerous psychiatric drugs to kids and studies show the scam is working. “The growing use of screening,” the Post noted, “has coincided with a rapid increase in the number of youngsters being prescribed powerful antipsychotic medications such as Risperdal and Zyprexa that have not been specifically approved for use by children.”

“A panel of government experts concluded two years ago that the evidence to justify suicide screening was weak,” the Post wrote, “and that such programs, although well intentioned, had potential adverse consequences.”

The Washington Post quoted Dr David Shaffer, the mastermind behind TeenScreen, and the program’s director, Laurie Flynn, as saying the goal is not to put children on medication but to alert parents to a problem, which they can then discuss with a pediatrician, a psychiatrist or a clergy member.

People even temped to believe that claim need to watch TeenScreen’s video-taped presentation at the annual convention of the country’s top pharma-bankrolled front group known as the National Association for Mental Illness, obtained by ace researcher Sue Weibert, which shows the TeenScreen crew telling the army of NAMI members from all across the US that helping TeenScreen might require them to contact a child’s insurance company to check on coverage or drive a child to an appointment with a shrink.

The video also shows the TeenScreen presenter passing around a pad of paper for the members to sign on as volunteers and agree to rise up against anyone who speaks out against TeenScreen when it moves into a new community.

In the video, the presenter goes on to explains the importance of tricking kids into agreeing to take the survey first, by bribing them with pizza or movie coupons or other perks, because according TeenScreen, the parents won’t agree to the survey so they need to win the kids over first and then send them home to talk the parents into it.

The statement that no drug company money is involved in TeenScreen is also false. The May 2002 issue of the Update Newsletter reporting on the implementation of a TeenScreen program in Nashville, Tennessee said: “Some 170 students responded to a “TeenScreen” survey conducted by NAMI Nashville and Columbia University.”

“TeenScreen was funded,” the newsletter said, “through grants from AdvoCare and Eli Lilly.” In fact, Eli Lilly funded the entire week of events, according to the newsletter.

Another fact not mentioned by TeenScreen to the Post, is that Laurie Flynn, was the former Executive Director of NAMI, until 2000 when she left to become Executive Director of the TeenScreen program.

Last time I checked, the NAMI website listed “Corporate Partners, Grants, and Foundations,” as Abbott, AstraZoneca, Bristol-Meyers-Squibb, Eli Lilly, Forest Lab, Glaxo-Smith-Kline, Jannsen, McNeil, Pfizer, and Wyeth.

So the truth is, during Flynn’s 16 year reign over NAMI, Big Pharma paid her salary. Internal NAMI documents obtained by Mother Jones Magazine, showed that over a period of 3 years, from 1996 to mid-1999, eighteen drug companies gave NAMI a total of $11.72 million, and included Janssen, Novartis, Pfizer, Abbott Labs, Wyeth-Ayerst, and Bristol-Myers Squibb.

Critics say the TeenScreen promoters deliberately inflate suicide numbers. “They are pulling numbers out of thin air – falsely presuming that this crisis is about lack of access to drugs and calling for government to provide more and more of what many of us believe is the wrong kind of treatment,” according to Robert Whitaker in an interview with Kelly O’Meara on May 16, 2003, in Insight News.

In truth, according to a government funded study in the Journal of the American Medical Association: “Despite a dramatic increase in treatment, no significant decrease occurred in suicidal thoughts, plans, gestures, or attempts in the United States during the 1990s,” Trends in Suicide Ideation, Plans, Gestures, and Attempts in the United States, 1990-1992 to 2001-2003, JAMA. 2005;293:2487-2495

As for TeenScreen not advocating for any medication, that happens to be untrue as well. In 1999, Flynn, wrote the forward to a book that was written to specifically promote the atypicals titled, “Breakthroughs in Antipsychotic Medications: A Guide for Consumers, Families, and Clinicians,” by Peter J Weiden, Ronald J Diamond.

On December 11, 2003, the New York Times reported that Dr Shaffer, at the request of a drug maker, attempted to block the recommendation to ban SSRI antidepressants from use in children in the UK by sending a letter to the British regulatory agency claiming there was insufficient data to restrict the use of the drugs in adolescents.

Critic say any child labeled mentally ill by TeenScreen will end up on drugs. “TeenScreen is purely and simply a marketing scam to sell psychotropic drugs,” according anti-child drugging activist, Ken Kramer.

“Mass mental health screening of American children,” Kramer says, “is absolutely, without a doubt, the most serious psychiatric threat to this nation.”

A survey of recently trained child psychiatrists seems to verify Mr Kramer’s assertions. The results of the survey showed that only one in 10 children in their practices did not receive a drug.

According to many experts, the other relatively new class of drugs being promoted through schemes like TeenScreen, the SSRI antidepressants, are playing a duel role in transforming healthy people into disabled individuals. Little attention has been given to the FDA’s warning that certain behaviors are “known to be associated with these drugs,” including “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania,” according to Dr Peter Breggin.

Dr Breggin, and a host of other experts, say a patient will often experience mania or psychotic episodes caused by the SSRI but instead of the doctor recognizing the drug induced adverse even, the patient is diagnosed as bipolar or schizophrenic and prescribed an atypical, in addition to the SSRI, in what experts refer to as a “drug cocktail.”

The prescribing of a drug cocktail paves the path for a life-long customer for Big Pharma. Since Prozac, the first SSRI, came on the market in 1987, the number of people diagnosed as disabled due to mental illness in the US has gone from 3.3 million to 5.7 million, according to Robert Whitaker, in Anatomy of an Epidemic: Psychiatric Drugs and the Astonishing Rise of Mental Illness in America; Ethical Human Psychol and Psychiatry 2005; 7: 23-33.

When in reality, the SSRI is the cause bizarre behaviors. “You see a fairly significant percentage of patients where new and more severe psychiatric symptoms are triggered by the drug itself,” Whitaker says.

So then, “instead of just dealing with depression, they’re dealing with mania or psychotic symptoms,” he said, “they’re given an antipsychotic to go along with the antidepressant; and, at that point, they’re moving down the path to chronic disability,” Whitaker told Street Spirit in August 2005.

Part of what we’re seeing, he says, is nothing more than the creation of a larger market for drugs. “It’s brilliant from the capitalist point of view,” he points out, “you take a kid, and you turn them into a customer, and hopefully a lifelong customer.”

Vince Boem, one of the nation’s most prolific researchers on psychotropic drugs, agrees with this theory and says, “Antipsychotics have the unique ability to create their own illness.”

“If you are not “schizophrenic” before you take these drugs,” he says “you will become a “schizophrenic” in short order.”

The most widespread physical problem found in children on atypicals is drastic weight gain which increases the risk of diabetes and heart disease. Obese children are twice as likely as normal kids to develop diabetes, according to a new University of Michigan study.

In an effort to determine whether atypicals were worth their enormous cost, the National Institute of Mental Health conducted one of the largest studies ever, the Clinical Antipsychotic Trials of Intervention Effectiveness, and $44 million tax dollars later, published the startling results in September 2005, with the conclusion that the new atypicals “have no substantial advantage” over the old ones.

But this is nothing new. In 2000 the British Medical Journal published the results of a study by Dr John Geddes, who examined clinical trials involving over 12,000 patients and the effectiveness and dangers of the new atypicals and the old antipsychotics in head-to-head trials and concluded:

(1) There is no clear evidence that atypical antipsychotics are more effective or are better tolerated than conventional antipsychotics.

(2) Conventional anti-psychotics should usually be used in the initial treatment of an episode of schizophrenia unless the patient has previously not responded to these drugs or has unacceptable extrapyramidal side effects.

In the latest side effect findings, the results of a US government study released in June 2005, revealed that patients taking Risperdal had a higher incidence of benign tumors in the pituitary gland. The FDA study was presented on June 18, 2005 at a University of Pittsburgh conference and described the methodology and findings as:

The researchers analyzed 2.5 million adverse events reported by doctors, patients, and individuals since 1968. Of the 307 reports of pituitary tumors, 64, or 21%, occurred in patients taking antipsychotics. Forty-eight reports of pituitary tumors were reported in patients taking Risperdal.

According to the June 17, 2005 Wall Street Journal. FDA warnings about the dangers of atypicals have not slowed down their use and obviously the only way to get through to Big Pharma is with litigation. And lawsuits are being filed all over the country in droves.

Although Eli Lilly settled thousands of Zyprexa lawsuit for about $670 million in June 2005, the company now faces thousands more claims, including three state lawsuits and government investigation into its marketing of Zyprexa.

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, attorneys for patients in California, Pennsylvania, Mississippi and Texas told Bloomberg.

A Dallas personal-injury attorney, told Bloomberg that he filed 2,500 Zyprexa suits in state courts primarily in California and Indiana. One case in Texas, filed in March 2006, by another law firm, involves 492 plaintiffs.

The lawsuits allege that Lilly knew of the risks associated with Zyprexa but did not warn doctors and consumers. “As early as 1998,” says a lawsuit filed in Indiana on behalf of 22 patients, “the medical literature conclusively revealed data that linked Zyprexa with causing diabetes.”

Many of the patients in the new lawsuits claim they took Zyprexa without knowing the risks because Lilly promoted the drug to doctors as an off-label treatment for illnesses other than schizophrenia and bipolar disorder.

Attorneys say Lilly has doctors prescribing Zyprexa for everything from women with post-partum depression to children acting out.

According to the June 12, 2006 New York Times, today more mentally ill patients die from diabetes and complications like heart disease than from suicide. “Uncontrolled diabetes can ruin a person’s life as much as uncontrolled schizophrenia,” Dr Newcomer, a professor of psychiatry at Washington University School of Medicine in St Louis, told the Times.

In a 2003 survey, the city’s health department found that about 17% of adults who reported symptoms of a mental illness, or about 52,000, also had diabetes.

The cost of atypical-induced medical conditions is taking a toll on publicly funded health care programs. “Mental illness is itself a money sponge,” the Times noted, “an expense borne largely by tax dollars.”

“But that cost may be dwarfed,” the article points out, “by the bill to manage the heart attacks and amputations that diabetes bestows.”

Alaska and West Virginia filed lawsuits against Lilly in February 2006, charging the company improperly marketed Zyprexa for unapproved uses costing the states millions of dollars after patients covered by state health care plans, such as Medicaid, developed diabetes and other diseases associated with the drug.

West Virginia is seeking payment for all medical costs related to Zyprexa, as well as reimbursement for the more than $70 million the state paid Lilly for Zyprexa. Under West Virginia law, any damages could be tripled the state alleges in its complaint.

Lilly committed fraud on the people of West Virginia in selling Zyprexa, says the state’s Attorney General Darrell McGraw and seeks to stop Lilly’s deceptive practices, collect damages, and create a fund for those who will develop diabetes and other diseases from taking Zyprexa.

“West Virginia’s Department of Health and Human Services has paid at least $70 million for Zyprexa in its Medicaid program since 1996,” the complaint states.

It claims studies have linked Zyprexa to diabetes since 1998 and that sales representatives misled and deceived doctors about the safety and efficacy of Zyprexa and that Lilly’s advertisements deceptively understated risks and overstated benefits of the drug.

The lawsuit alleges that Lilly promoted “off label” use of Zyprexa for anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, according to McGraw, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.

“The money paid by the State would not have been paid to Lilly except for its fraudulent conduct,” the complaint states. “Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs,” it also alleges.

In addition to damages, McGraw is seeking reasonable attorney fees and other costs and fees as well.

Another lawsuit was filed against Lilly in New York in August 2005, on behalf of private health insurers that accuses the drug maker of violating racketeering laws by bankrolling nonprofit groups and paying doctors, consultants and marketing companies to promote Zyprexa as an off-label treatment for numerous unapproved conditions, while downplaying the drug’s adverse effects.

Two more class actions were filed in a federal court in New York, on February 28, 2006. The first lawsuit is asking for reimbursement for all money paid by consumers and non-government health plans for Zyprexa and the second demands payment for monitoring of all people who may have taken Zyprexa but have not yet been diagnosed with pancreatitis, diabetes or high blood sugar.

Filed under: 2006, antipsychotics, drugging children, front groups, MEDICAID, NAMI, RISPERDAL, TeenScreen, TMAP, Zyprexa

Public Has Right To Know Secrets Revealed In Zyprexa Documents

Evelyn Pringle January 15, 2007

In deciding whether to allow Eli Lilly to continue to use court orders to hide documents that show the company illegally marketed Zyprexa for unapproved uses and failed to warn the public about the serious health risks associated with the drug for a decade, the court needs to consider the harm done to the public by Lilly’s conduct.

The public has a right to know everything about the drugging for profit scheme revealed in the documents since the majority of profits made off Zyprexa came from the public trough. The court needs to recognize the harm done to tax payers in billing public health care programs like Medicaid for the massive off-label sale of the drug. According to the October 23, 2005, San Francisco Chronicle, nationwide, Medicaid programs purchase an estimated 60 to 75% of antipsychotic drugs.

In California for instance, in the year ending June 2005, Zyprexa was the highest expenditure at close to $250 million. On November 28, 2005, the Indianapolis Business Journal listed Zyprexa as the most costly antipsychotic covered by South Carolina’s Medicaid program with a month’s supply of 20-milligram tablets costing South Carolina $700.52 at the time.

On September 29, 2005, Bloomberg News stated that Medicaid could reduce the “$5.5 billion it spends annually on schizophrenia drugs for the poor” because a study found the cheaper generic, perphenazine, about as effective as new drugs, including Zyprexa.

“The 40-year-old drug perphenazine costs less than $1.50 a day,” Bloomberg wrote, “while the newer medicines can cost 10 times as much.”

When buying a 3-month supply, at drugstore,com, the retail price for Zyprexa in September, 2005 was $1,500, and a 3-month supply of perphenazine, was only $135.

Lilly has even found ways to convince doctors within the Veteran Administration’s hospital system to prescribe Zyprexa rather than the older, cheaper and equally effective drugs. Dr Robert Rosenheck, a Director with the Department of Veterans Affairs, reviewed the prescribing records for schizophrenic patients in the VA system for 2003 and found that more than 80% were on the new antipsychotics. He calculated that the VA spent more than $208 million on antipsychotics that year, with over $106 million, or more than half, spent on Zyprexa.

According to the New York Times, the company documents at issue show that Lilly knew full well about Zyprexa’s association with diabetes and weight gain that often leads to diabetes. The public’s right to know about this charge can not be easily dismissed considering the costs to the public of paying for the care of the tens of thousands of Zyprexa victims who developed diabetes.

By using fraud, kickback and antitrust statutes, state attorneys general all over the US are filed lawsuits against Lilly to recover the money paid for Zyprexa, and the medical costs for patients harmed by Zyprexa, whose health care is covered by public programs.

In February 2006, West Virginia and Alaska filed lawsuits against Lilly alleging the company marketed Zyprexa for unapproved uses in those states and as a result it has cost millions of dollars to care for patients who developed diabetes and other diseases.

West Virginia is seeking payment for all medical costs related to Zyprexa, in addition to the more than $70 million the state paid for the drug. The lawsuit says studies have linked Zyprexa to diabetes since 1998, and that sales representatives misled doctors about the safety and the efficacy of Zyprexa and that Lilly’s advertisements deceptively understated its risks and overstated its 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. “Lilly benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs,” the complaint states.

A lawsuit was filed by the attorney general of Mississippi, Jim Hood, in July 2006, to recoup the ill-gotten gains that Lilly enjoyed by promoting the off-label use of Zyprexa in that state, and alleges that Lilly knew Zyprexa increased the risk of diabetes, because in April, 2002, nearly a year and a half before Lilly first warned doctors and consumers in the US, the company changed Zyprexa’s labeling in the UK and Japan to include warnings about the drug’s association with diabetes related injuries.

Tim Balducci, Mississippi special assistant attorney general, says Lilly targeted Mississippi because the state’s Medicaid program is not set up to signal when a doctor prescribes a drug off-label.

According to Mr Hood, about 10% of Zyprexa patients have developed diabetes, some of whom are children, even though Zyprexa “has never been approved for, nor found to be effective, in the treatment of children.”

The fact is, Lilly has doctors prescribing Zyprexa off-label to children and billing state Medicaid programs all over the country. For instance, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found the number of Tennessee children covered by TennCare, 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, and a 61% increase in use with preschool children.

In Texas, a review of prescription records for the months of July and August 2004, found that more than 19,400 teenagers were prescribed antipsychotics 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.

With nearly 98% of the teens, ACS reported, the antipsychotics were prescribed off-label 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 drugs, and one-third were on 2 or more drugs.

Research published in the March/April 2006 Journal of Ambulatory Pediatrics, led by Dr William Cooper at Vanderbilt University, analyzed data drawn from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey, which are national samples of health care services rendered to the US population and conducted by the National Center for Health Statistics.

Between 1995–2002, the study found that there were nearly 6 million outpatient visits to health care providers by children between the ages of 2 and 18, during which an antipsychotic was prescribed. Nearly 80% of the visits occurred in physician’s offices, 14% in outpatient clinics, and 9% in emergency departments.

The authors of the research pointed out that there had been no increase in mental health disorders that could account for the increases “as recent studies do not suggest significant increases in the incidence of schizophrenia,” they stated.

“In addition,” the researchers noted, “schizophrenia and psychosis accounted for only 13.5% of the total antipsychotic visits during the study period, so this diagnosis alone could not explain the increase.”

“Therefore,” they said, “the most likely explanation for the study results is that similar to our findings in the Tennessee Medicaid population, there was a substantial increase in physician prescribing of antipsychotics during the study period.”

Experts say the side effects of Zyprexa are more common and severe in children than in adults. The Children’s Hospital of Philadelphia recently found that 19% of children who were newly diagnosed with Type 2 diabetes were being treated with the new antipsychotics.

Zyprexa is not only dangerous when used by children, it is less effective than the older cheaper antipsychotics. A study published in August 2006, by the New York Psychiatric Institute, found that the older antipsychotics worked much better, with the average response rate in children using the new antipsychotics at only 55.7%, compared to a 72.3% response rate among children who were given the older drugs.

The study also found that the average weight gain in patients treated with the older drugs was much lowers and the sedation side effect was less common. The authors of this study also pointed out that the FDA “has not approved any antipsychotic drugs for treating childhood schizophrenia; yet, clinicians routinely use medications for this disorder.”

There is no doubt that Lilly knew about these serious health risks long before it issued warnings in the US in 2003. 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 and found 289 cases of diabetes reported, with 225 patients being 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. The review identified 23 deaths, including a 15-year-old who died of necrotizing pancreatitis.

Last month, the New York Times reported details from the documents that Lilly wants to keep hidden, and revealed that Lilly sales representatives were promoting Zyprexa with primary care physicians specifically for the off-label treatment of dementia.

Before allowing Lilly to keep this information secret, the court needs to consider the harm being done to elderly citizens. On April 11, 2005, the FDA announced that elderly patients with dementia who were given antipsychotics were far more likely to die prematurely than those given placebos and also announced the addition of black box warnings about the increased risk of death on the labels of Zyprexa and the other atypical antipsychotics.

A June 13, 2005, study in the Archives of Internal Medicine, reviewed antipsychotic use in nursing home for approximately 2.5 million Medicaid beneficiaries and found that “over half (58.2%),” received drugs that exceeded the maximum recommended dosage, received duplicate therapy, or had inappropriate conditions for the drugs to begin with. The study determined that more than 200,000 residents received antipsychotic therapy but had “no appropriate indications for use.”

In October 2005, the Journal of the American Medical Association published a meta-analysis of trials of more than 5,000 elderly patients treated with atypical antipsychotics that found that patients had a 54% increased chance of dying within 3 months, compared to patients taking a placebo.

Lilly has also been actively promoting the off-label sale of Zypexa in other countries. In August 2006, Janet Currie, the director of the Victoria-based Psychiatric Medication Awareness Group in Canada, called for a public inquiry into the use of atypical antipsychotic because they are being prescribed to children and the elderly for sedation and behavioral control.

According to Ms Currie, Zyprexa is a special authority drug that may only be prescribed under special criteria and 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.

In Canada, payment for Zyprexa comes from the government funded PharmaCare program and according to BC health ministry data, the program paid $26,493,119 for Zyprexa in 2005.

Lilly is also facing numerous lawsuits in Canada alleging the exact same conduct revealed in the documents that Lilly is trying so desperately to suppress. According to Lilly’s SEC filings, in 2005 the company 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,” Lilly states in the filing, “are similar to those in the litigation pending in the United States.”

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 for unapproved uses and to downplay the medicine’s side effects.

Evidence to support these allegations can be found in Kentucky. When Kentucky held public hearings to try to exclude Zyprexa from Medicaid’s list of covered drugs, the most notorious Big Pharma backed front group in the US, the National Alliance for the Mentally Ill, bused in protesters for the hearings, placed full-page ads in newspapers, and sent faxes to state officials. However, a little known fact is that by funneling money through NAMI, Lilly paid for the buses, ads, and faxes, according to the December 18, 2003 New York Times.

Should the court continue to allow Lilly to hide the documents with the incriminating information, it will not be surprising to many experts. For as pediatrician, Dr Lawrence Diller, author of the book, “Should I Medicate My Child,” stated in language relevant here, while testifying before an FDA advisory committee in September 2004, regarding the conduct of companies concealing the adverse effects of drugs and promoting off-label prescribing:

“The blame is clear: The money, power and influence of the pharmaceutical industry corrupt all. The pervasive control that the drug companies have over medial research, publications, professional organizations, doctors’ practices, Congress, and yes, even agencies like the FDA, is the American equivalent of a drug cartel.”

And it is clear in this instance, that the thousands of lawsuits filed against Lilly have done nothing to deter it from promoting the off-label sale of Zyprexa. According to Lilly’s SEC filings, sales worldwide in the second quarter of 2006, were $1.12 billion, a 2% increase over the second quarter of 2005.

In the filing, Lilly noted that US sales of Zyprexa were down 1%, but said the company simply charged a higher price for the drug to make up for the lower sales.

To date, Lilly has agreed to pay about $1.2 billion to settle claims with roughly 26,000 litigants who alleged among other things, that the company promoted the sale of Zyprexa for off-label uses and concealed the health risks associated with the drug.

But legal experts say to look for more settlements soon as Lilly tries to avoid public trials in the Medicaid fraud cases, where it will be easy to prove that Zyprexa sales would have spiraled downward long ago, had Lilly quit promoting the drug for off-label use.

Filed under: 2007, Eli Lilly, front groups, MEDICAID, NAMI, prices, settlement, Zyprexa

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