The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Ablechild – Unsung Hero in Battle Against Psychopharmaceutical Industry

Evelyn Pringle

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

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

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

Long Battle Against Coerced Drugging

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

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

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Filed under: 'ADHD', 2010, Ablechild, CHADD, drugging children, front groups, MEDICAID, Ritalin, TeenScreen

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 1

Evelyn Pringle May 29, 2007

Federal lawmakers are stepping up the pace to put a stop to the pharmaceutical industry’s customer recruitment schemes used to boost the sale of psychiatric drugs by tugging at heartstrings in promoting mental health screening programs as suicide prevention tools.

On May 18, 2007, US House of Representative Ron Paul (R-Texas), a physician by calling, introduced a federal legislative bill HR 2387 that would block federal funding for any mandatory mental health screening programs. At last count, 12 other members of the House were listed as co-sponsors of the bill.

First of all, contrary to the lie that the industry is trying to sell the pubic, there is no epidemic of child suicides. There are roughly 50 million school-age children in this country, and according to the June 16, 2006, Washington Post, there were only 1,737 suicides by children and adolescents in 2003, the last year for which national statistics are available.

In addition, experts have said over and over that screenings do not work. A March 28, 2002 paper, “Suicide in the United States,” by Jane Pearson, PhD, chairman of the National Institute of Mental Health Suicide Research Consortium at the time, states: “[W]hen researchers have tried to predict suicide using as many known risk factors as possible, they are still unable to predict who will and who will not commit this act.”

In the paper, she also verifies a real danger that screening critics are concerned about, in stating that, “a prevention program for high-school aged youth found that participants were more likely to consider suicide a solution to a problem after the program than prior to the program.”

According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, “No matter how we define mental illness in children or adults, it cannot be found by simple screening.”

“Nobody can, by merely looking at someone else, or even on the basis of a pen and pencil questionnaire,” he says, “differentiate the transient emotional disturbances we all have from those which last longer.”

Dr Lehrman also says screenings won’t prevent suicide because those who are contemplating it usually won’t tell. “Only when gross insanity exists can “mental illness” be recognized on inspection – and then we need neither experts nor screening,” he states.

“There are as many causes of depression as there are people suffering from it,” he explains

“Troubled people can indeed benefit from good mental health care,” he advises, “But good treatment requires addressing voluntarily a patient’s unique individual problems.”

“For this, screenings are unnecessary,” he adds.

The drugs marketed with the screening programs are the new generation of selective serotonin reuptake inhibitor antidepressants (SSRIs), including Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, which were falsely promoted as more effective than the older class of drugs in treating depression while the increased risk of suicide by patients taking the drugs was concealed.

The other drugs are the new class of atypical antipsychotics with brand names of Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon. It should be noted that the atypicals were FDA approved for the limited use of treating adults with schizophrenia and manic episodes of bipolar disorder, also known as manic-depression, the most serious of all mental illnesses.

These new drugs obviously do not work. A June 2005 study lead by researchers from Harvard Medical School, funded mostly by the National Institute of Mental Health, found that although there has been a dramatic rise in the treatment of mental disorders over the past decade, there had been no corresponding drop in the rate of suicidal thought and behaviors in adults.

The study pointed out that there had been a huge increase in the use of antidepressants during the 10-year period studied, but the rate of suicidal ideation, gestures and attempts has not changed at all.

Dr Barry Duncan, author of “What’s Right With You,” also says, “rates of depression have not changed for thirty years,” and, “suicide rates, despite the millions taking antidepressants, have not reduced.”

Dr Duncan points out that more than 150 million prescriptions worth $14 billion were written for antidepressants in 2003 alone.

However, evidence continues to mount that shows SSRIs are linked to suicide. On May 25, 2007, MedPage Today reported a study that found young suicide victims were significantly more likely to have SSRIs in their bloodstream than were young homicide or accident victims.

“In an analysis of ‘unnatural’ deaths recorded by the Virginia Medical Examiner’s Office for 1987 through 2003,” MedPage wrote, “Antony Fernandez, MD, and colleagues, found that selective serotonin reuptake inhibitors or the serotonin-norepinephrine reuptake inhibitor venlafaxine appeared significantly more often in post-mortem toxicology of suicides than of accident or murder victims.”

This latest study echoes a report by records researcher Ken Kramer that found most child suicides in Florida were by children who are already on psychotropic drugs. Mr Kramer analyzed every autopsy and toxicology report on every child suicide in the state of Florida from 2000 to 2004.

“The majority,” Mr Kramer says, “had already received psychiatric drug treatment even with the FDA warnings that say these drugs can cause mania, suicide, psychosis, worsening depression and even homicidal thoughts.”

A recent March 2007 report by the Government Accountability Office on Pediatric Drug Research states: “About two-thirds of drugs that are prescribed for children have not been studied and labeled for pediatric use, placing children at risk of being exposed to ineffective treatment or incorrect dosing.”

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for a drug maker to promote off-label uses, but doctors are allowed to prescribe a drug for any use they choose. However, almost without exception, the lawsuits now pending against psychotropic drug makers accuse the companies of influencing doctors to prescribe the medications for off-label uses.

Critics say this profit-driven drugging of patients recruited with screening programs has got to stop, because a whole generation of Americans are becoming disabled right before our eyes, and lawmakers should realize that the government is going to have to pay to care for these disabled people for life and not just their medical care, but for their very existence.

Linda Hurcombe, author of “Losing a Child: Explorations in Grief,” admits that her concerns about mental health screening programs arise from a personal tragedy. She is a US citizen living in the UK where prescription drug advertising is illegal, but her daughter fell victim to drug advertising while she was visiting the US.

“A few years ago my undepressed teenage daughter saw an antidepressant ad on American television,” Linda explains, “and on her return to our rural home she went to her doctor and asked for the drug.”

“It took her about eight minutes to persuade the doctor,” Linda says, “followed by 63 days of descent into chaos which ended in her suicide by hanging.”

“As far as patient advocacy is concerned,” she notes, “it is alluring to an increasingly health-aware public to demand more knowledge.”

“But what sort of ‘knowledge’ is likely from a gaggle of marketing moguls?” she points out.

“We must give the marketing men and women their due,” Linda says, “as they medicalize the human condition from the cradle to the grave.”

“Disturbing examples,” she points out, “include toddlers taking mint-flavoured Prozac for bipolar disorder, antsy kids being calmed with methamphetamines, people diagnosed with ‘intermittent explosive disorder’ [read 'anger'], being medicated instead of addressing the causes of the stress in their lives.”

Linda has a new book, “Depression: healing emotional distress,” coming out soon.

Even with the limited approved uses for atyicals, last year drug makers sold more than $15 billion in antipsychotic drugs, according to data compiled by Bloomberg. Lilly’s Zyprexa generated $4.4 billion in sales last year, and Johnson & Johnson’s Risperdal had sales of $4.2 billion. Sales of Abilify climbed 41 percent to $1.3 billion.

Some of the known adverse events associated with these drugs include rapid weight gain and high blood sugar levels which are risk factors for diabetes, and disfiguring tics, dystonia which produces involuntary, often painful muscle contractions, heart attacks and sudden death in elderly patients.

Sales figures are so high because the makers of atypicals have doctors prescribing the drugs for all kinds of unapproved uses. On May 10, 2007, the New York Times reported that when Anya Bailey developed an eating disorder at 12 years old, her mother took her to a psychiatrist at the University of Minnesota who prescribed Risperdal.

Risperdal is not approved for treating eating disorders or any disorder in 12 year olds.

Anya gained weight, the Times noted, but within 2 years, she developed a crippling knot in her back the result of a nerve condition called dystonia, and now receives regular injections of Botox to unclench her back muscles and she often wakes up crying in pain.

The Times reported that the mother was surprised to learn that her daughter received a drug for a treatment not approved by the FDA, but was more surprised to learn that the psychiatrist who supervised Anya’s care received more than $7,000 from 2003 to 2004 from Risperdal maker Johnson & Johnson, in return for giving lectures about one of the company’s drugs.

These new drugs are being fed to so many people in all age groups for uses not approved by the FDA that experts say its often impossible to determine whether a symptom is caused by a mental disorder or a side effect from a drug.

Dr Elliot Valenstein, PhD, author of “Blaming the Brain”, says, “It is now difficult to find mental patients who have not had a history of drug treatment, and as a result many of the brain abnormalities found in these patients are probably iatrogenic, that is, produced by the treatment rather than being the cause of the disorder.”

“It is well established,” he advises, “that the drugs used to treat a mental disorder, for example, may induce long-lasting biochemical and even structural changes, which in the past were claimed to be the cause of the disorder, but may actually be an effect of the treatment.”

Dr Lehrman warns that the screening programs will “harm thousands of Americans by giving them stigmatizing diagnoses which can follow them for the rest of their lives, and then drugging them.”

In some cases, patients, including children as young as 2, are being given SSRIs, atypicals and ADHD medications all at the same time in drug cocktails that would make any patient act crazy. And when the weird behaviors start, the dosages of the drugs are increased and often another medication is added to the mix to treat the “new strange behaviors” which are actually side effects from the drug cocktail.

The serious side effects associated with these drugs are only now being revealed to the public and health care providers because the drug companies concealed studies that showed the adverse events had occurred in their own clinical trials years ago.

Also, the drug makers are starting to pay dearly for a decade of illegal marketing practices and the concealment of the adverse effects of the drugs.

For instance, to date, Eli Lilly has spent more than $1 billion to settle out of court with about 26,000 Zyprexa victims, with still more litigants waiting in the wings. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

The company is also facing lawsuits by 10 states and 4 class actions, filed on behalf of shareholders, charging Lilly with fraud in promoting the off-label sale of Zyprexa while concealing its side effects.

Zoloft maker Pfizer’s March 2007 SEC filing states in part, “A number of individual lawsuits have been filed against us in various federal and state courts alleging personal injury, including suicide and suicide attempt in certain cases, as a result of the purported ingesting of Zoloft.”

Pfizer will no doubt be facing more lawsuits in the near future because Zoloft has now been linked to life-threatening birth defects in babies born to mothers who took the drug during pregnancy.

Filed under: 'ADHD', 2007, antipsychotics, Birth Defects, drugging children, Fraud, settlement, SSRIs, suicide, 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

Investigations Target SSRI Prescribing Doctors

Evelyn Pringle February 23, 2007

In recent years, Federal and state investigators have been going after the makers of the antidepressants known as the selective serotonin reuptake inhibitors (SSRI), for promoting the drugs for off-label use under the theory that they are causing the submission of false claims to Medicare, Medicaid, and other public health care programs.

If a drug is FDA approved for one indication, doctors may prescribe it for another. But it is illegal for drug companies to promote a drug for off-label uses in attempt to influence doctors prescribing habits as a means of boosting sales.

Off-label refers to treating conditions not listed on the drug’s label or increasing the dose or duration of treatment beyond that specified on the label. It also means prescribing drugs in combinations with others or prescribing a drug to an unapproved patient group such as children or the elderly. If an indication is not listed on the label it means the drug has not been tested and approved as safe and effective for that use.

Government programs cover drugs that are approved by the FDA when they are medically necessary. However, when off-label promotion is used to induce doctors to prescribe drugs for unapproved uses, public health care programs pay for those prescriptions and government spending goes up.

The list of health risks found to be associated with SSRIs over the past decade is staggering, but not as staggering as the number of people who have been prescribed these drugs for bogus disorders including everything from shyness to the latest invented disorder called the “hoarding syndrome.”

The SSRIs have now been positively linked to adverse effects that include suicide, extreme violence and aggression leading to homicide, several serious life-threatening birth defects, fertility problems, sexual dysfunction, a dangerous long-lasting withdrawal syndrome and the list goes on and on.

With the new Democrat controlled Congress, the investigation of illegal off-label marketing schemes is picking up speed and investigations will no longer be limited to the drug companies. The middle man pushers, also known as prescribing physicians, on the receiving end of kickbacks will also be placed under intense scrutiny.

Public hearings on the issue have already begun. While testifying at a House Committee on Oversight and Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of Health and Human Services’ Office of Inspector General, said: “Kickbacks potentially increase the costs to Federal programs because they encourage overutilization and may encourage the prescribing of more expensive drugs when clinically appropriate and cheaper options (such as generic drugs) may be equally effective.”

“Equally troubling,” he said, “kickbacks can compromise the independence of medical decision making by putting the financial interests of the physician ahead of the welfare of the patient.”

“In OIG’s experience,” Mr Morris told the committee, “kickbacks offered to prescribing physicians by pharmaceutical manufacturers take a variety of forms, ranging from free samples for which the physician bills the programs to all-expense-paid trips and sham consulting agreements.”

According to testimony at the same hearing by, Ronald Tenpas, associate deputy attorney general in the Department of Justice, one kickback scheme discovered involved providing free drugs to doctors and then instructing them how to bill Medicaid and Medicare for the drugs causing the government to even pay for the illegal kickbacks used to induce doctors to prescribe the drugs.

“The Anti-kickback Statute,” Mr Tenpas says, “remains a vital law enforcement tool in assuring that sound medical judgment is not subverted by the payment of inducements that sometimes cause medical professionals to prescribe drugs based on financial considerations and not medical necessity or safety.”

Mr Morris noted that in the past, prosecutors have focused on the companies paying the kickbacks and not on the prescribing doctors. “This may have created the misimpression by some physicians,” he said, “that they can demand kickbacks from drug companies with impunity.”

With this in mind he told the panel, the “OIG has stepped into this breach and is using its authority to impose program exclusion and significant monetary penalties to target these kickback recipients.”

“Hopefully,” Mr Morris told the committee, “OIG administrative enforcement also will prompt physicians to think twice before accepting kickbacks from pharmaceutical companies.”

However, kickbacks are but one method used to influence doctors prescribing habits. During an October 10, 2002, lecture in Rome, Dr Lawrence Diller, a behavioral-developmental pediatrician, and author of, The Last Normal Child, said advertising and promotion to physicians may be the most alarming and pernicious influences.

“For years,” Dr Diller said, “doctors in the U.S. have been inundated with professional magazine ads, drug salesman visits, free samples for patients and more recently monetary inducements to attend “educational” seminars or act as consultants for meetings that aren’t anything more than promotional events for a new drug.”

Drug companies also use direct to consumer advertising to promote off-label uses. According to Dr Diller, “the role of the pharmaceutical industry cannot be underestimated in its influence on the way American’s think about themselves and their children.”

In 2004, the FDA cited two antidepressant makers for over promoting the use of their drugs in commercials aimed at consumers. It cited Effexor maker, Wyeth Pharmaceuticals for a radio ad in which the announcer said:

Hey, you, listening to the radio … how’re you feeling these days? OK? Not bad? Come on, is that where you want to be? When was the last time you did something you once looked forward to doing? You know, symptoms of depression could be holding you back.

At the time, Effexor XR, was approved to treat major depressive disorder and the FDA said the radio ad failed to convey the “serious nature of major depressive disorder” and to “distinguish symptoms of depression from variations of normal daily functioning.”

“As a result,” the FDA stated, “it broadened the audience for Effexor XR.”

GlaxoSmithKline also received a citation for advertising Paxil on television for too many types of patients. The FDA said the drug was approved to treat social anxiety disorder, characterized by “marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny.”

A Paxil TV ad, the FDA advised, in which characters became stressed over social situations such as being at a party, failed to distinguish between social anxiety disorder “and lesser degrees of performance anxiety or shyness that do not generally require psychopharmacological treatment.”

The success of SSRI off-label promotion efforts is evident in all age groups. According to Dr Richard Kadison, chief of mental health at the University Health Services, Harvard University, in the September 15, 2005, New England Journal of Medicine, “the number of prescriptions has increased dramatically over the past decade; it is estimated, for example, that 25 to 50 percent of U.S. college students who are seen in counseling and at student health centers are taking antidepressants.”

At least in part, he says, such consumer demand reflects our bombardment with advertisements imploring us to “ask your doctor if this pill is right for you.”

“This type of marketing is a double-edged sword,” Dr Kadison warns, “not only raising awareness of common problems such as depression … but also implying that there is a magic bullet for complex problems and enticing some healthy people to seek their own magical boost.”

Christopher Kilmartin, professor of psychology at the University of Mary Washington, also blames advertising for the increased use of psychotropic drugs. It used to be companies could only market to physicians and psychiatrists, he says, but now they are allowed to create a market by not only advertising a drug to treat a disorder but with ads to convince people they have a disorder.

According to Dr Kilmartin, normal human struggles are pathologized and then people feel as though they are deficient and need some sort of treatment.

But kids are being recruited as SSRI customers long before they head to college. One of the most successful, and alarming, off-label marketing scheme that needs to be investigated is the TeenScreen program. By use of TeenScreen, the drug companies have gained access to the nation’s 50 million public school children.

Billed as a mental illness screening program aimed at suicide prevention, it is already being administered to students in schools all across the country and children are being labeled mentally ill on a regular basis, with the only treatment offered naturally being drugs.

Tugging at the heartstrings, TeenScreen is presented to naive parents as a harmless little survey that may save their kids from suicide. However, parents are not being told about the life-long consequences that can result from a child’s diagnosis of mental illness by way of this harmless survey.

Critics say this particular scheme is so evil that people can not even bring themselves to consider that drug companies would go so far as to implement this type of program in the public school system to drug kids for profit. They also say that parents had better think again.

There is no teen suicide epidemic in this country. In fact a recent government survey found that although SSRI use has multiplied every year for the last 10 years in a row, there has not been any decline in the suicide rate.

The TeenScreen program is set up to recruit patients from the most lucrative and consistent customer base available in the US and few other off-label marketing schemes have drawn the outrage expressed over this one.

The family of a teen who was labeled mentally ill by TeenScreen in Indiana is suing the school for allowing their daughter to be screened without their knowledge and consent.

The young girl took the survey and was diagnosed with not one, but 2 mental illnesses: obsessive compulsive disorder and social anxiety disorder.

Even government experts say suicide prevention screenings do not work. On June 16, 2006, Ned Calonge, former chairman of the US Preventive Services Task Force, and now the chief medical officer for the Colorado Department of Public Health and Environment, who in 2004 reported that the Task Force found no evidence that screening for suicide reduces suicides or that screening tools are accurate, spoke to the Washington Post and said the same findings still apply:

“The panel would reach the same conclusion today… Whether or not we like to admit it, there are no interventions that have no harms… There is weak evidence that screening can distinguish people who will commit suicide from those who will not… And screening inevitably leads to treating some people who do not need it.

“Such interventions have consequences beyond side effects from drugs or other treatments… Unnecessary care drives up the cost of insurance, causing some people to lose coverage altogether.”

Government investigators are going to have to delve much deeper than looking for kickbacks to doctors if they plan to have any success in shutting down the highly profitable off-label marketing pipeline to kids.

All that said, the worst part about drugging children with SSRIs, is that after hundreds of millions of prescriptions have been written, experts now say they do not work with kids. In the vast majority of studies, most of which were kept hidden by the SSRI makers and only surfaced as a result of litigation, the drugs were no more effective than a placebo.

A team of researchers led by psychologist, David Antonuccio, from the University of Nevada Medical School, analyzed 12 studies on the use of SSRIs with children and told an FDA advisory committee on February 2, 2004: “Our conclusions were that the advantages of the antidepressants in children were so small and so trivial as to be clinically insignificant.”

“An increased risk of suicidal behavior,” he told the panel, “is certainly not justified by these minimal benefits.”

“Clinically meaningful benefits,” Dr Antonuccio testified, “have not been adequately demonstrated in depressed children, therefore, no extra risk is warranted.”

“The highest possible standard should be applied to scientific data involving drug treatment of children,” he told the panel, “because children are essentially involuntary patients.”

He pointed out the unfortunate fact that parents make children take the drugs whether they want to or not.

Filed under: 2007, drugging children, DTC, KOL, SSRIs, TeenScreen

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Christiane Schultz

  • Is not coping well at all. Loss sucks! 4 years ago
  • is scared to bond with this baby, just in case. 4 years ago
  • Happy 6 months today baby. I love you Matthew. 4 years ago
  • Living with loss, sucks. 4 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 5 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

RSS BREATH

  • Untitled
    Originally posted on The Bitter Pill:Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a…
  • Untitled
    Originally posted on The Bitter Pill:In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

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