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

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part I

Evelyn Pringle August 30, 2007

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, Fraud, KOL, MEDICAID, SSRIs, TMAP

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part II

Evelyn Pringle September 2, 2007

Influence peddling in the field of psychiatry is out of control. An analysis of Minnesota disclosure records by the Pioneer Press and the consumer watchdog group Public Citizen shows that, between 2002 and 2006, 187 Minnesota doctors received payments from drug companies worth a grand total of $7.38 million.

No other field of medicine even comes close to that amount. The next highest specialty was neurology, with 99 doctors receiving $2.89 million, according to the analysis.

In psychiatry, drug makers underwrite decision makers at every level of care, according to a May 10, 2007, report by Gardiner Harris in the New York Times. “They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow,” Mr Harris states.

He determined that, between 2000 and 2005, payments to Minnesota psychiatrists increased more than six-fold. The Times also analyzed Minnesota Medicaid records, and the report provides details on how the financial relationships between doctors and drug makers have played a major role in the growing use of atypical antipsychotics with children.

The drugs include Zyprexa, marketed by Eli Lilly; Seroquel, by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.

The drugs are the most powerful psychiatric drugs on the market and were FDA-approved only to treat adults with schizophrenia or adults in the manic phase of bipolar disorder.

Over the past three years, every atypical maker has come under fire for influencing doctors to prescribe the drugs off-label to children for uses never approved by the FDA, and they are all currently involved in litigation related to the illegal promotion and sales of the drugs.

A study at Columbia University on the use of antipsychotics with children found that only a small percentage of the kids on the drugs had psychotic disorders and that, most of the time, the drugs were prescribed to treat mood disorders, depression, anxiety and ADHD.

Mr Harris reports that the Minnesota psychiatrists who received the most money from the drug’s makers tended to prescribe them to kids the most often. On average, psychiatrists who received at least $5,000 between 2000 to 2005 appeared to have written 3 times as many prescriptions for kids as psychiatrists who received less or no money, the Times notes.

The rising Medicaid costs for atypicals also coincides with the rising payments to doctors. For instance, Minnesota Medicaid spent roughly $521,000 in 2000 on antipsychotics for children; but in 2005, the cost was more than $7 million, or a 14-fold increase.

In June 2007, Vermont officials revealed that disclosure records in that state showed payments to psychiatrists had more than doubled in one year, from an average of $20,835 in 2005, to an average $45,692 in 2005. There, too, antipsychotics were among the highest Medicaid drug expense.

The drug makers have shrinks in their pockets all over the country. However, only 3 states, Minnesota, Vermont and Maine, have laws that require companies to disclose their payments.

The media’s recent reporting that members of a Minnesota advisory panel who decide which drugs will be covered by the state’s Medicaid program are on the take, adds a new chapter to an old book. This same scam has been used in states all over the country since the late 1990′s, and if not for two relentless fraud investigators from Pennsylvania, the fact that the formulary committees are bought and paid for by the pharmaceutical industry might have remained a secret for all time.

The fact that drug makers were bribing state policy makers and members of advisory panels with the ultimate goal of capturing the lucrative Medicaid customer base to increase the sale of psychiatric drugs was first discovered several years ago by Allen Jones, while he was a federal fraud investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations, and Dr Stefan Kruszewski, a pediatric psychiatrist by trade, who was hired by the Pennsylvania Department of Public Welfare to review the quality of care provided to persons covered by state programs.

According to Mr Jones, “the pharmaceutical industry has systematically infiltrated the mental health service delivery system of this nation.”

“The situation uncovered in Minnesota,” he says, “will be exposed in every state that demonstrates the political will to force transparency through full disclosure of industry payments to decision makers.”

“Thinly veiled bribery of public officials by the pharmaceutical industry is a pervasive and deeply rooted problem,” he warns.

During his investigation in Pennsylvania, Mr Jones found a drug money trail to key policy officials who controlled the Medicaid preferred drug list in that state, which eventually led him to Texas and an elaborate scheme that involved influential psychiatrists, including many who served as professors at Texas universities, and state policy officials who developed the preferred drug list known as the “Texas Medication Algorithm Project (TMAP)”.

Mr Jones calls the Texas panel the “most transparent example” of industry influence, because all of the project directors had financial ties to the drug makers. It was put into effect, he says, by buying off doctors who were considered “opinion leaders” in the psychiatric field, along with state policy makers in positions of authority with control over the preferred drug lists.

For instance, Dr John Rush, from the University of Texas Southwestern Medical Center, served as the TMAP Project Co-Director with Dr Steven Shon, the Medical Director of the Texas Department of State Health Services.

Mr Jones determined that Dr Rush had received grants, research funding and served as a consultant and speaker for atypical makers Bristol-Myers, Janssen, Eli Lilly and Pfizer.

The director for the schizophrenia module was Dr Alexander Miller, of the University of Texas Health Science Center at San Antonio, who also served as a consultant, advisory board member and speaker for AstraZeneca, Bristol-Myers, Lilly, Janssen and Pfizer.

The director of the bipolar disorder module was Dr Patricia Suppes, from the University of Texas Southwestern Medical Center in Dallas, who also received grants and research funding and served as a consultant for AstraZeneca, Bristol-Myers, Janssen, Lilly and Pfizer.

Other University of Texas professors who participated in the development of TMAP included psychiatrist Dr Graham Emslie, who has received grants and research support and served as a consultant and member of speakers’ bureaus for atypical makers Bristol-Myers, Lilly and Pfizer.

Another professor, Dr Karen Dineen Wagner, was a member of the speakers’ bureaus for Janssen, Lilly and Pfizer, and a member of a scientific advisory board for Lilly, Janssen and Pfizer and received research funding from the same 3 atypical makers and Bristol-Myers.

Once the formulary was in place in Texas, the drug makers paid Dr Shon to travel around the country to convince policy makers in other states to use the TMAP model for their Medicaid approved list. Pennsylvania adopted the program and called it PennMap.

Mr Jones found that Janssen paid for Dr Shon to fly to Pennsylvania two times, and a document he obtained shows that the grant covering Dr Shon’s travel expenses was “to expand atypical usage.”

The New York Times reported that some payments were made through patient advocacy groups instead of directly to state officials. In 2002, Janssen gave the Olympia, WA, chapter of the National Alliance for the Mentally Ill a grant of $15,000 to fly Dr Shon and other Texas officials to speak to state legislators about the formulary, the Times found.

While reviewing the medical care provided to patients under state care in the summer of 2002, Dr Kruszewski immediately recognized that a mass drugging-for-profit scheme involving Medicaid patients, especially children, was taking place in Pennsylvania, and that several patients had died.

In one case, where the child fortunately survived, Dr Kruszewski found that the girl had been placed on 11 psychiatric drugs at the same time, including 5 antipsychotics, without ever being diagnosed with a psychiatric disorder. She exhibited impulsive behaviors and was mentally disabled, but there was nothing in the records to justify the use of all these drugs, he says.

According Dr Kruszewski, the atypicals are associated with an increased the risk of obesity which can lead to diabetes type II, hypertension, heart attacks and stroke. The weight of the girl who was on 11 drugs had ballooned from 106 pounds to 194, Dr Kruszewski found.

In reviewing patient records, he found a state-wide pattern where patients who were not mentally ill were placed on cocktails of 3 or more expensive psychiatric drugs at the same time and kept on the cocktails indefinitely and if patients experienced side effects from the original medications, more drugs were added to the mix.

The sheer greed evidenced by the mass drugging of patients on Medicaid all over the US, similar to that discovered by Dr Kruszewski in Pennsylvania, has forced state Medicaid programs to either put a stop to the drug maker’s encouragement of the rampant prescribing of atypicals or go broke.

For instance, Texas Medicaid was charged nearly $15 million for antipsychotics for foster children in 2004, according to the December 2006 Special Report, “Foster Children – Texas Health Care Claims Study.” In fact, Texas spent more money on antipsychotics for foster kids than any other class of drugs, and the report said, Zyprexa, Seroquel and Risperdal typically cost an average of $229 per prescription.

The report also pointed out that the drugs were not approved for children, and listed the health risks associated with the atypicals and stated, in part:

“These very powerful and expensive medications were prescribed despite a lack of studies demonstrating their safety and efficacy in children. There are questions regarding the long-term safety of these medications; documented serious side-effects include menstrual irregularities, gynecomastia, galactorrhea, possible pituitary tumors, hyperglycemia, type 2 diabetes and liver function abnormalities.”

In a May 10, 2006 Press Release, Comptroller Carole Keeton Strayhorn said she was “particularly concerned” about the use and side effects of the atypical antipsychotic drugs.

“A clear pattern of overmedication and potential misdiagnosis of foster children is evident,” she said and the “potential for Medicaid fraud and the possibility of long-term health problems in these children is alarming.”

A USA TODAY study of FDA data from 2000 to 2004 found 45 pediatric deaths in which atypicals were the primary suspect, with at least six related to diabetes and other causes ranged from heart and pulmonary problems to Zyprexa, choking and liver failure.

A 15-year-old boy died of an overdose, an 8-year-old boy died of cardiac arrest, a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin, and the youngest death was a 4-year-old boy whose symptoms suggested diabetes complications, who was also taking 10 other drugs.

A July 29, 2007, report by Robert Farley in the St Petersburg Times revealed that in the last 7 years, the cost to Florida tax payers for atypicals prescribed to children jumped nearly 500%, from $4.7 million to $27.5 million, and on average in 2006, it cost the state nearly $1,800 for each child on atypicals.

Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics 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 say children younger than 6 should generally not be given psychotropic drugs and they should “only be considered under the most extraordinary of circumstances.”

According to Mr Jones, these new “miracle” drugs have proven to be no better than generics, and, “it is a statistical certainty that many lives have been lost and many others irreparably damaged.”

In September 2005, the New England Journal of Medicine, reported that although Zyprexa was the most expensive and most prescribed antipsychotic, it was the only atypical that worked slightly better than the 40-year-old generic drug, perphenazine, but the NEJM also noted that Zyprexa had more side effects. The cost for a 3 month supply of Zyprexa in September, 2005 at drugstore.com, was $1,500, while a 3 month supply of perphenazine was only $135.

And the atypical drugging for profit scheme is not limited to the Medicaid population. An analysis revealed in March 2006 by investment firm CIBC World Markets showed that in the previous 12 months, the top 20 drugs in managed care spending included Zyprexa with $2.6 billion, Seroquel at $2.5 billion, and Risperdal was $2.2 billion.

The corrupt psychiatrists in Minnesota and other states might want to think about what is happening to “professionals” who were involved in similar behavior in Pennsylvania and Texas.

In Pennsylvania, the state Ethics Commission determined that Pfizer operated its own “Advisory Boards,” comprised exclusively of formulary committee chairmen from various states who received honorariums and all-expense-paid trips from Pfizer at the same time they were evaluating Pfizer drugs for use in state mental health systems.

The Commission determined that Steven Fiorello, Director of the Pharmacy Services in the Office of Mental Health and Substance Abuse Services in Pennsylvania, and Chairman of the Formulary Committee, had used his office to obtain private pecuniary benefits for his participation in Pfizer’s advisory board meetings in New York when he received honoraria for his participation in the meetings, as well as for his presentations at conferences in Orlando, Florida and Dublin, Ireland.

Mr Jones found that Mr Fiorello traveled to Pfizer’s world headquarters in Manhattan 3 times to participate in advisory board meetings, with all expenses paid for by Pfizer, including lodging at Manhattan’s Millennium Hotel and he was paid an honorarium of $1,000 for attending each meeting.

The Commission also found a number of additional violations, including Mr Fiorello’s receipt of honoraria from other companies for whom he made presentations in connection with his public employment, and ordered Mr Fiorello to make restitution of $27,268.50 and referred the case to the Pennsylvania Attorney General’s Public Corruption Unit.

On November 21, 2006, Mr Fiorello was charged with two counts of conflicts of interest, one count of accepting honoraria and one count of failing to disclose income on annual Statements of Financial Interests. In a press release, Pennsylvania’s Attorney General stated: “As part of his responsibilities, Fiorello served on a committee that decided which drugs would be used for mental health treatment in all state hospitals – decisions which guided more than $9 million in annual drug purchases by the Commonwealth.”

He also noted that, “while Fiorello was helping to guide the purchase of various drugs by the Department of Public Welfare, he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board.”

Down in Texas, Dr Shon was fired last fall after the state’s attorney general found that Janssen had improperly influenced him to list Risperdal on the state formulary. An October 9, 2006, letter to Dr Shon from Dr Charles Bell, acting commissioner of the Texas Department of State Health Services, obtained by the Austin American-Statesman states: “It is my determination that your services are no longer required by the Department.”

“I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately,” Dr Bell wrote.

In addition, Texas is now closely monitoring the prescribing of psychiatric drugs to Medicaid patients, and several psychiatrists have been ordered to reimburse the state for the cost of the drugs they prescribed to foster children.

Texas and Pennsylvania have also recently filed Medicaid fraud lawsuits against the makers of Zyprexa, Risperdal and Seroquel, seeking to recoup the cost of the drugs prescribed to Medicaid patients, as well as the medical care for persons injured by the drugs.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, Fraud, KOL, MEDICAID, SSRIs, TMAP

American Kids Being Drugged To Death

Evelyn Pringle August 22, 2007

As result of the marketing power the pharmaceutical industry obtained by spending tens of billions of dollars to gain influence over politicians in power, the FDA and the medical profession, American kids are being pumped full of the most powerful and dangerous psychiatric medications on the market, in drug cocktails that are literally killing them.

Neurologist Dr Fred Baughman, author of “The ADHD Fraud,” calls the leadership of the psycho-pharm-government cartel (FDA, NIMH, White House New Freedom Commission on Mental Health) the biggest, most evil drug cartel in history. “At least the pusher of ‘crack’ on inner city streets does not come in a white coat,” he says.

According Dr Baughman, kids have become “for-profit receptacles” for psychiatric drugs which will forever alter their brains and bodies. And its happening all across America he says, not by thousands but by tens of thousands.

Experts say the drugging regime usually begins by doctors convincing parents that their children have attention deficit disorder, and the medications prescribed are the exact same drugs that street addicts call “speed.” They include the amphetamines Adderall, Dexedrine, and methylphenidates such as Ritalin and Concerta.

FDA records show that, between 1999 and 2003, seventy-eight million prescriptions were written for ADHD drugs for children ranging in age from one to 18. A review of adverse events posted on the FDA web site reveals that, between January 2000 and June 30, 2005, there were nearly 1,000 reports of psychosis or mania possibly linked to ADHD drugs, with psychosis characterized by the inability to distinguish real and imaginary events.

“The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD,” according to a March 3, 2006, memo penned by two members of the agency’s ADHD psychiatric review team.

FDA records also show reports of 25 deaths in children and adults between 1999 and 2003, and 54 cases of serious cardiovascular problems, including stokes, heart attacks, hypertension, palpitations and arrhythmia. But according to Dr Baughman, in addition to the deaths cited by the FDA, the MedWatch database also contains 186 more deaths of persons using ADHD drugs for the period between 1990 and 2000.

Dr Grace Jackson, author of “Rethinking Psychiatric Drugs: A Guide for Informed Consent,” says that “whether by ignorance or design, the FDA remains oblivious to the evidence-based limitations of ADHD drugs.”

She notes that at least 40% of children fail to respond or tolerate stimulant therapy, “and about twice as many respond at least as well to non-pharmacological interventions.”

“The link between stimulants, cardiovascular disease, and death,” Dr Jackson reports, “is well documented but doctors and government regulators have refused to acknowledge the dangers associated with the drugs.”

The long-term outcomes for kids on ADHD drugs, she says, show diminishing effects over time, including “artificial behavioral improvements” which end when the medication is withdrawn.

Because stimulant drugs cause insomnia, sleeping pills are now being fed to children to counteract the insomnia side effect. Medco Health Solutions, a managed-care firm, found an 85% increase in the use of sleeping pills among children between 2002 and 2004.

One of the world’s leading authorities on psychiatric drugs, Dr Peter Breggin, founder of the International Center for the Study of Psychiatry and Psychology and the journal Ethical Human Sciences and Services, warns that all ADHD drugs can cause “a continuum of stimulation, which includes agitation and irritability, anger, hostility, disinhibition, hypomania and mania.”

The activation syndrome, he says, was observed decades ago with the amphetamines like Adderall and Dexedrine, and methylphenidates such as Ritalin and Concerta.

As an unrecognized side effect to most doctors, the syndrome more often than not results feeding the kids more drugs. As a child’s emotional control breaks down due to the stimulant effects, Dr Breggin says, mood stabilizers such as antiseizure medications and antipsychotics may be added to the mix. “Eventually,” he states, “these kids end up on four or five psychiatric drugs all at once and toddlers are even being diagnosed with bipolar disorder.”

The new generation of “atypical” antipsychotics, originally approved only to treat adults with schizophrenia and bipolar disorder, which include Zyprexa (Eli Lilly), Risperdal (Johnson & Johnson), Seroquel (AstraZeneca), Abilify (Bristol-Myers Squibb), Clozaril (Novartis) and Geodon (Pfizer), were not approved for any condition in children, but studies of Medicaid records and HMO databases found an alarming increase in the use of these drugs by kids, particularly for behavioral disorders such as ADHD, according to the spring 2006 issue of the Journal of Ambulatory Pediatrics.

Researchers led by Dr William Cooper at Vanderbilt University analyzed data on health care services rendered in the US and found that between 1995 and 2002, there were 5,762,193 outpatient visits where children between the ages of 2 and 18 were prescribed an antipsychotic.

The researchers explained that there had been no increase in mental disorders and noted that, “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.”

A USA TODAY analysis of the FDA’s adverse event reporting system between 2000 and 2004 found at least 45 deaths of kids where the “primary suspect” was an atypical and more than 1,300 reports of other serious side effects.

Dr Breggin has served as an expert witness in several cases that resulted in favorable verdicts for the plaintiffs in which Risperdal caused a condition known as tardive dyskinesia in children, when it was prescribed in attempt to control behaviors that were in fact caused by ADHD drugs.

He explains that tardive dyskinesia is a neurological movement disorder that is often mistaken for a mental illness because the symptoms are so “strange” and “bizarre.” The abnormal movements, he says, can affect any muscle group in the body and impair the ability to speak, walk, breathe and swallow.

According to Dr Breggin, this serious disorder occurs at a cumulative rate of between 4% and 7% in otherwise healthy patients taking antipsychotics each year and after only a few years, 20% or more of patients will be afflicted.

The drug makers have apparently found ways to influence the prescribing habits of Canadian doctors, because the new antipsychotics are now being doled out in record numbers to Canadian children for behavior and mood problems, with a significant proportion for children under nine, according to new research from Canada.

On June 18, 2007, Sharon Kirkey of CanWest News reported that ninety-four per cent of 176 child psychiatrists in Canada surveyed are prescribing the antipsychotics for a variety of disorders and symptoms, including anxiety, attention-deficit hyperactivity disorder and “poor frustration tolerance,” citing a study in the Canadian Journal of Psychiatry

Risperdal was the most commonly prescribed, followed by Zyprexa and Seroquel. The report said that a “surprising” number of the prescriptions were for the very young, with 12% written for children aged eight or under, including three-year-olds, and noted that none of the drugs has been officially approved for use in children in Canada.

Lilly, J&J and AstraZeneca are currently named as defendants in Medicaid fraud lawsuits related to the illegal off-label marketing of Zyprexa, Risperdal and Seroquel, filed to recover money paid for patients’ use the drugs, as well as the costs of medical care for patients injured by them.

In addition, investigations in several states have recently started looking into the behind-the-scenes financial relationships between the drug makers and some of the doctors who have been heavily involved in promoting the prescribing of the drugs for off-label uses.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, Breggin, drugging children, SSRIs

It’s Time To Sue Doctors Who Prescribe Drugs Off-Label – Part I

Evelyn Pringle August 15, 2007

Critics say the tens of thousands of lawsuits filed against the drug giants have had little impact when it comes to dismantling the off-label drug marketing schemes and therefore, there needs to be an all out campaign of highly publicized lawsuits filed against the doctors serving as middle man pushers, one by one by one.

It is illegal for a drug company to promote a drug for uses not listed on the FDA-approved label for the simple reason that the drug maker has not successfully proven to the FDA that the drug is safe or effective for uses not listed on the label.

However, because of a legal loophole wider than a barn door, doctors have the authority to prescribe a drug for an unapproved use if they believe a patient would benefit, which means all a drug maker has to do is find doctors willing to promote the off-label uses and deny the drug company’s involvement in the scheme.

And recent studies on prescribing habits have shown that the drug companies have found thousands of doctors all across the US in every field of medicine more than willing to participate in drugging for profit schemes by writing prescriptions that result in fees paid for monthly office visits that require no more than a few minutes of the doctor’s time.

Critics says the first round of lawsuits should be filed against the quacks involved in prescribing psychiatric drugs to millions of children who are now stigmatized for life by a label of mental illness and will face a life-time of discrimination in finding jobs and obtaining health insurance due to a trail of medical records showing a history of taking drugs used to treat the most severe mental illnesses of major depression, bipolar disorder and schizophrenia.

Critics point out that doctors in fields of medicine that have never before involved the diagnosing and treatment of mental illness would never have come up with the idea to prescribe psychiatric drugs off-label to children without the illegal prompting from the drug makers.

For example, on June 20, 2004, the Florida Sun-Sentinel reported that a review of Medicaid records in that state found doctors with specialties in dermatology, nutrition, anesthesiology, ophthalmology, allergy, radiology, plastic surgery, hematology, obstetrics, pathology, diabetes, rheumatology, and hand surgery wrote prescriptions for psychotropic drugs for children aged 12 and younger between September 2002 to September 2003.

In record numbers, children are being fed powerful psychiatric drugs, often in combination with each other, including selective serotonin reuptake inhibitor antidepressants like Paxil, Cymbalta, Lexapro, Celexa, Prozac, and Zoloft and the new generation of “atypical” antipsychotics, such as Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify.

Children are also receiving drugs for ADHD in record numbers including the stimulants Adderall, Dexedrine and Ritalin, often combined with drugs approved only to treat adults with epilepsy such as Depakote and Neurontin.

Experts say its not uncommon to see children on an SSRI, an antipsychotic, a stimulant drug, and a sleeping medication all at the same time. Neurologist, Dr Fred Baughman, author of, The ADHD Fraud, warns that multiple drugs are being prescribed together in combinations that are lacking of any scientific basis.

Most critics say the ever-expanding list of invented disorders is the driving force behind this mass-drugging for profit. “While the drug companies certainly are getting rich providing mind-altering drugs for psychiatry’s made-up mental disorders, the fault for the fraud of psychiatric diagnosing lies with the psychiatric community,” says investigative journalist, Kelly Patricia O’Meara, author of “PSYCHED OUT: How Psychiatry Sells Mental Illness and Pushes Pills That Kill”.

Harvard Instructor Dr John Abramson, author of, “Overdosed America,” calls it a “progressive medicalization” of undesirable behavior in children. “We have seen this in the enormous proliferation of stimulant medication use,” he notes, “far out of proportion to use in other countries.”

Now the diagnosis of bipolar disorder in children is rising in parallel, he says, and clearly it is the drug industry driving this medicalization to sell more products.

Other experts agree. On February 15, 2007, the New York Times reported comments by Dr Bessel van der Kolk, a professor of psychiatry at Boston University who also treats children at a trauma clinic. “Most of the patients I see who have been misdiagnosed,” she said, “have been told they have bipolar disorder.”

“The diagnosis is made with no understanding of the context of their life,” she said. “Then they’re put on these devastating medications and condemned to a life as a psychiatry patient.”

Former Clinical Director of Kingsboro Psychiatric Center in Brooklyn, Dr Nathaniel Lehrman also says, “relying on medication as the definitive treatment of psychiatric complaints, rather than addressing their real causes in patients’ lives, is responsible for the gross overuse of psychiatric medications, especially among children.”

He is especially critical of the ADHD diagnosis. “Its “symptoms” acting impulsively; easy distractibility; interrupting others; constant fidgeting or moving; and difficulty in paying attention, waiting one’s turn, planning ahead, following instructions, or meeting deadlines, can be found in any of us,” Dr Lehrman points out.

A study in the August 3, 2004 Archives of Pediatric Adolescent Medicine reported that the rate of antipsychotics use by children covered by a public health care program in Tennessee had nearly doubled between 1996 and 2001, and had increased 61% with preschoolers.

A review of Medicaid records in Ohio for the month of July 2004, found 18 newborn to 3 year-old babies had been prescribed antipsychotics and 28 more in the same age group were on antidepressants, according to the April 25, 2005 Columbus Dispatch.

According to the December 2006 Special Report entitled, “Foster Children – Texas Health Care Claims Study,” in 2004, psychotropic drugs accounted for more than 76% of the cost of all medications prescribed to foster children in Texas on Medicaid.

Of all drugs prescribed, the study found antidepressants, antipsychotics and stimulants were the most frequently prescribed and half of the children in a sample of 472, received 3 or more drugs from different classes at the same time and 27.5% received 4 or more, with antidepressants and antipsychotics being the two most commonly prescribed together.

The same year, Texas also spent nearly $4.8 million on nearly 43,000 anticonvulsants used as mood stabilizers for about 4,500 foster children, including 133 aged four and younger, as well as close to $4.5 million on 45,318 stimulant prescriptions for more than 6,500 foster children including nearly 200 who were aged 4 and under.

There were also nearly 2,500 prescriptions written for hypnotic/sedative drugs for about 1,000 foster children, including 232 four and younger to treat anxiety or sleep disorders.

In addition, more than 400 of the foster children were prescribed antidyskinetics drugs to control side effects caused by the antipsychotics which included tremors, tics, dystonia, dyskinesia and tardive dyskinesia.

Last year in Florida, Medicaid records show that more than 1,100 children 6 and under were prescribed antipsychotics at a cost to Medicaid of nearly $1,800 per child and most were prescribed to treat mood disorders, depression, anxiety or ADHD. In addition, 367 Florida toddlers 3 and under were prescribed ADHD drugs in 2006.

The debate about the over-drugging of children has been festering behind the scenes for a decade, but the all-out war between medical professionals recently exposed in the media is the result of the widespread outrage over the highly publicized overdose death of the 4-year-old toddler, Rebecca Riley in Hull, Massachusetts in December 2006.

The outrage began when the police investigation revealed that Rebecca was given the diagnoses of ADHD and bipolar disorder by Dr Kayoko Kifuji, at the Tufts-New England Medical Center, when she was only 2 and half-years-old and placed on a 3-drug cocktail of Clonidine, a drug approved to treat adults with high blood pressure, Depakote an antiseizure drug approved to treat adults with epilepsy, and Seroquel, approved to treat adults with schizophrenia or the mania of bipolar disorder.

Investigators also reported that Dr Kifuji had diagnosed Rebecca’s 6-year-old sister and 11-year-old brother with the same disorders and kept them on the same 3-drug cocktail even longer than Rebecca. The mother and father were also diagnosed mentally ill and the whole family was covered by Medicaid, according to police reports.

In a June 17, 2007 report in the Boston Globe, reporter Scott Allen discussed Rebecca’s death and the rising dissent within the medical profession. Under the headline, “Backlash on bipolar diagnoses in children,” he noted that psychiatrist, Dr Joseph Biederman of Massachusetts General Hospital, “could be credited more than any other” for convincing Americans that even small children can develop bipolar disorder.

“From his perch as one of the world’s most influential child psychiatrists,” Mr Allen wrote, “Biederman has spread far and wide his conviction that the emotional roller coaster of bipolar disorder can start “from the moment the child opened his eyes” at birth.”

Critics also identify Dr Janet Wozniak, director of the Pediatric Bipolar Disorder Research Program at Massachusetts General, as a researcher who has worked side by side with Dr Biederman to promote the bipolar diagnosis for children.

On June 19, 2007, pediatrician, Dr Lawrence Diller, author of “Should I Medicate My Child,” publicly denounced their research and what he called “misguided standards of care” in an editorial in the Boston Globe and informed the world that he had recently done “the nearly unthinkable” at a medical conference on bipoloar disorder in children.

“I charged another doctor,” he stated, “with moral responsibility in the death last December of Rebecca Riley, a 4-year-old girl from Hull.”

He acknowledged that he understood the risks of naming names. “Yet I felt compelled,” he said, “to name Joseph Biederman, head of the Massachusetts General Hospital’s Pediatric Psychopharmacology clinic, as morally culpable in providing the “science” that allowed Rebecca to die.”

According to Dr Diller, Dr Biederman shocked the child psychiatric world in 1996 by announcing that nearly a quarter of the kids he was treating for attention deficit disorder also met his criteria for bipolar disorder. “Up until then,” he says, “bipolar disorder was rarely diagnosed in teenagers and unheard of in prepubertal children.”

Dr Diller says there are thousands of potential Rebecca Rileys being treated with multiple psychiatric drugs because Dr Biederman has said it’s OK and necessary.

Critics say the tens of thousands of lawsuits filed against the drug giants have had little impact when it comes to dismantling the off-label drug marketing schemes and therefore, there needs to be an all out campaign of highly publicized lawsuits filed against the doctors serving as middle man pushers, one by one by one.

It is illegal for a drug company to promote a drug for uses not listed on the FDA-approved label for the simple reason that the drug maker has not successfully proven to the FDA that the drug is safe or effective for uses not listed on the label.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, Fraud, Kifuji, KOL, SSRIs

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