The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Maryanne Godboldo is back in court!

Judge postpones decision on Godboldo criminal case after Court of Appeals reversal

“(WXYZ) – The Detroit mother who refused to hand her daughter over to child protective services workers made was back in court Friday.

It’s case that made headlines around the world.

When Maryanne Godboldo refused to hand her daughter over to Child Protective Services in March of 2011, she never expected a police standoff complete with tanks and the swat team.

Godboldo was charged with 8 felonies, allegedly for firing a gun into her ceiling when police broke down her door.

“We can’t lose sight of the fact that this was a mother who was protecting her daughter from a very dangerous and deadly drug being forced upon her by CPS,” said Allison Folmar, one of Godboldo’s attorneys.”

Here is the video link tied to this article: http://www.wxyz.com/news/local-news/investigations/judge-postpones-decision-on-godboldo-criminal-case-after-court-of-appeals-reversal

Maryanne will be back in court on March 14th…all of us in the Psychiatric Survivors Movement will be watching closely.

Jenny Hatch

jenny hatch logo

Here is a video put together by CCHR on Maryannes amazing attorney Allison Folmar

I had Maryanne on my radio show a couple of years ago, click HERE to listen to our podcast.

Filed under: involuntary hospitalization, Jenny Hatch, Jenny Hatch Radio Show, RISPERDAL, , , ,

Makers of Zyprexa Risperdal and Seroquel Under Fire

Evelyn Pringle March 9, 2007

Eli Lilly, Johnson & Johnson, and AstraZeneca, are all named defendants in a new lawsuit filed by the state of Pennsylvania on February 26, 2007, to recover money paid through public health care programs to purchase Zyprexa, Risperdal, and Seroquel, and the costs of medical care for the people injured by these drugs.

Pennsylvania is the 5th state to sue Lilly over its illegal marketing of Zyprexa. And according to SEC filings, Lilly was served with four Canadian lawsuits in 2005, with claims “similar to those in the litigation pending in the United States.”

So far, two states have sued Johnson & Johnson over Risperdal, but Pennsylvania is the first state to file a lawsuit against Seroquel-maker AstraZeneca.

The drugs belong to a class known as “atypical” antipsychotics, FDA approved only to treat adults with schizophrenia or bipolar disorder, and yet they are some of the most widely prescribed drugs in the world. In 2006, Zyprexa sales were $4.3 billion, Seroquel’s earned $3.4 billion, and Risperdal had sales of $4.1 billion, according to SEC filings.

A July 2006, report by Decision Resources, a leading advisory firm on healthcare issues, listed antipsychotics in 2005, as the fourth-highest-ranking class of drugs, and said two of the top ten drugs in worldwide sales were atypicals.

According to the lawsuit, the defendant drug makers concealed the risks of atypicals and exaggerated their benefits while persuading doctors to prescribe the drugs off-label for dementia, attention deficit disorders, and mood and behavior disorders.

When the FDA approves a drug it also approves the label, which lists the indications for which the drug can be prescribed, along with instructions for use and warnings about the risks associated with the drug. Once a drug is approved to treat one condition, doctors may prescribe it for others if they think it will be effective, but by law drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.

On March 1, 2007, four days after the Pennsylvania lawsuit was filed, two of the three drug companies became the target of another investigation, when Representative, Henry Waxman (D-Cal), the chairman of the House Oversight and Government Reform Committee, sent letters to Eli Lilly and AstraZeneca, requesting information related to the exact same charges alleged in lawsuits filed by individual states.

The letter sent to Lilly states in part, “Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa,” and requests information relevant to these allegations.

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

In addition, Rep Waxman wants Lilly to turn over all internal company documents that were kept under seal for years with a court order, but were provided to him by Attorney, James Gottstein, in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

According to the New York Times, some of these documents reveal that Lilly knew about Zyprexa’s link to high blood sugar and extreme weight gain that often leads to diabetes, and others show the details of off-label marketing scheme called “Viva Zyprexa.”

Rep Waxman’s letter to AstraZeneca basically asks for the same documents requested from Lilly except that he requests more information related to the physicians and authors involved in company sponsored studies and writing the reports.

Late last year, the atypical makers also received subpoenas from the attorney general of California seeking much of the same information.

In pursuing the Pennsylvania lawsuit, Governor Edward Rendell, has hired private attorneys. According to the complaint, the defendants cost Pennsylvania millions of dollars “for non-medically accepted indications and non-medically necessary uses of Zyprexa, Seroquel and Risperdal,” as well as “significant sums of money for the care and treatment” of patients injured by the drugs.

The Pennsylvania case comes on the heels of lawsuits by two Pennsylvania whistleblowers, Allen Jones and Stefan Kruszewski, who say, drug companies are making a fortune from the off-label sale of drugs to patients whose care is funded by Medicaid and Medicare.

At the heart of the off-label scheme, they say, are the preferred drug lists, or medication formularies, maintained in many states. Once drugs are added to the list, they must be prescribed as a first line of treatment for all patients in state run institutions and patients in the general population who are covered by public health care programs.

In the summer of 2002, psychiatrist, Dr Kruszewski, was employed with the Pennsylvania Department of Public Welfare, and charged with reviewing psychiatric care provided by state-funded agencies to identify waste, fraud, and abuse. He was also responsible for reviewing the deaths of individuals in state care who died under suspicious circumstances in facilities inside and outside of Pennsylvania.

Early in his investigation, Dr Kruszewski noticed that almost all of the patients under state care were on drug cocktails consisting of antipsychotics, antidepressants, and anticonvulsants. The populations he found drugged most often, he said, were children in state care, the disabled, people in state prisons, and children in the juvenile justice system.

For instance, he says, Neurontin was only approved for controlling seizures, but “was being prescribed for anxiety, social phobia, PTSD, oppositional defiant behavior, and attention deficit disorder with no evidence to support these uses.”

When he informed his superiors about the high rate of off-label prescribing and warned about the risk of liability to the state of Pennsylvania if it continued, he was told, “it is none of your business.”

In June 2003, Dr Kruszewski inspected a facility in Oklahoma that housed children from Pennsylvania after an unexpected death of a child, and found children were being overmedicated and housed in deplorable living conditions, in addition to being sexually and physically abused by staff and kept in unnecessary restraints and seclusion.

In a report, Dr Kruszewski recommended removing the children from the facility, “in order to protect other innocent individuals from morbid and mortal consequences of severe over-medication, including chemical restraints; emotional, physical and sexual abuse; seclusion; and dirty and inadequate living conditions.”

A day later, Dr Kruszewski was accused of “trying to dig up dirt,” and was subsequently fired in July 2004, because he refused to keep quiet and accept that it was none of his business, he says.

A year later, Dr Kruszewski filed a whistleblower lawsuit alleging that patients under state care were being drugged for profit and prescribed as many as 5 psychiatric drugs at the same time, and that four children and one adult had died.

In his action, Dr Kruszewski alleged that his superiors violated his right to free speech by firing him because he made statements about the abuses in the state system, which were a matter of public concern.

Dr Kruszewski is represented by attorneys from Government Accountability Project, Thad Guyer, Stephania Ayers, Tom Devine, and Mark Cohen, in Federal Court in the Middle District of Pennsylvania with Chief Judge Yvette Kane presiding.

Defendant, Christopher Gorton, is the Chief Medical Officer for DPW, who fired Dr Kruszewski. He filed a motion for summary judgment to dismiss the First Amendment claim on the basis that the law does not protect whistleblowers if they are fired for making comments they would be expected to make in the context of their employment.

In reading the Court’s March 2, 2007, Decision denying Mr Gorton’s motion, it appears that Mr Gorton tried to have it both ways. When Dr Kruszewski was employed and tried to report the harm to people under state care, he was told it was none of his business and to quit digging up dirt. Under oath in a deposition, Dr Kruszewski stated that he was told that the subjects of his statements were not part of his job duties.

However, in his motion, Mr Gorton now claims that Dr Kruszewski’s comments were made pursuant to his official employment duties. In her written opinion, Judge Kane, quoted relevant case law to describe comments that are protected:

“A public employee’s statement is protected activity when (1) in making it, the employee spoke as a citizen, (2) the statement involved a matter of public concern, and (3) the government employer did not have an adequate justification for treating the employee different from any other member of the general public as a result of the statement he made.”

“The statements in question can be categorized,” Judge Kane wrote, “as: (1) reports regarding poor quality of care, including abuse of patients by staff at treatment facilities; (2) complaints about the lack of qualifications of another private contract doctor; and (3) statements about use and costs of medications.”

In order to grant a motion for summary judgment, a judge has to find that there are no genuine disputes of material fact that would require a jury to resolve. In this case, Judge Kane found there were disputes regarding Dr Kruszewski’s job duties and whether his statements were substantial and motivating factors in his termination.

In his motion, Mr Gorton claims the statements were not protected speech, but then says, even if they were, they were not a factor in his decision to terminate Dr Kruszewski, because he was unaware of the statements when he decided to fire Dr Kruszewski.

However, Judge Kane found evidence in the record that, “if credited by a fact-finder,” she wrote, “would support Plaintiff’s claim that Gorton knew of at least some of Plaintiff’s protected statements.”

“Because there remain genuine disputes of material fact,” she states, “regarding Plaintiff’s job duties and whether Plaintiff’s statements were substantial and motivating factors in his termination, the Court cannot grant summary judgment for Defendant Gorton.”

According to Dr Kruszewski, apart from all the legal wrangling, his focus remains on trying to protect Pennsylvania citizens against unwarranted drugging, sexual and physical abuse, and unnecessary restraint and seclusion.

His original lawsuit alleges that drug companies used “political friendships, money, and other emoluments” to achieve “a level of influence with Pennsylvania’s state government” to promote “the use of their products.”

These charges echo those previously made by the other Pennsylvania whistleblower, Allen Jones, who was also a fraud investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, and was fired after he informed his superiors that drug companies were funneling money to state officials and policy makers in positions of influence over the state’s preferred drug formulary known as PennMap.

Last year, Mr Jones settled a whistleblower lawsuit in Pennsylvania, also with the assistance of the Government Accountability Project. While he did not agree to a gag order regarding his concerns, he did agree not to discuss the terms of the settlement.

During his investigation, Mr Jones found collusion between drug companies and several state officials and specifically, Steven Fiorello, Pennsylvania’s chief pharmacist, a valuable player because he monitored pharmacy operations at 9 state hospitals and served on the committee that determined which drugs would be prescribed to patients in state hospitals.

On November 21, 2006, Mr Fiorello was arraigned on two felony counts of conflict of interest and misdemeanor counts of accepting money and failing to disclose the income on his yearly financial interest statements.

A year and a half earlier, the Pennsylvania State Ethics Commission had determined that Mr Fiorello had repeatedly violated state ethic laws by using his position to earn money from drug companies. To settle the charges with the Ethics Commission, Mr Fiorello paid fines totaling $27,269, before the case was referred for criminal prosecution.

Down in Texas, another state official, Dr Steven Shon was fired from his job in October 2006, after the state’s attorney general, Greg Abbot, found J&J had improperly influenced Dr Shon to list Risperdal in a state formulary called the “Texas Medication Algorithm Project,” or TMAP, while receiving money from J&J.

In December 2006, Mr Abbott joined another whistleblower lawsuit filed by Mr Jones, against J&J, alleging in part, that the company misrepresented the safety and effectiveness of Risperdal and unduly influenced Dr Shon and others, to make it a drug of choice for persons covered by public health care programs in Texas.

TMAP required doctors to prescribe atypicals rather than the older, less expensive antipsychotics. “The plan,” Mr Jones explains, “was part of a larger scheme designed to infiltrate public institutions to influence prescribing practices in which drug companies bought the opinions of a few key doctors and state policymakers, and opened the door for spending billions of tax dollars on dangerous drugs.”

The Texas lawsuit describes exactly how the TMAP preferred drug list was developed in Texas in 1997, and according to the complaint, Dr Shon traveled around the country at J&J’s expense to convince officials in other states to adopt the TMAP model, which is now used in 17 states.

The lawsuit says, J&J promoted Risperdal by influencing policymakers with trips, perks, travel expenses, speaking fees and other payments and that Risperdal was recommended as the drug of choice for children, even though it was not approved for use with children.

TMAP was highly successful in getting doctors to prescribe atypicals to kids. According to an investigation of psychiatric drug use by Texas children on Medicaid, ACS-Heritage, a medical consulting firm, found 19,404 teens were prescribed an antipsychotic in July or August of 2004, with nearly 98% being atypicals.

ACS also found that more than half of the doses were inappropriately high, almost half of the prescriptions did not appear to have diagnoses warranting their use, and one-third of the children were on two or more drugs.

The Texas lawsuit alleges that J&J concealed Risperdal’s link to hyperglycemia, stroke, and renal failure, to qualify for reimbursement under Medicaid, and that Texas seeks to recover money paid to purchase the drug for off-label uses and the cost of medical care for the people injured by Risperdal.

In 2005 alone, according to the Texas Health and Human Services Commission, Texas paid for approximately 308,000 Risperdal prescriptions at a cost of $73.5 million.

Critics say, the Governor of Pennsylvania is suing atypicals makers now to portray a hard stance against the pharmaceutical industry because he wants to run for higher office, when in reality, he has known about the PennMap off-label scheme for years.

The consensus is that Mr Rendell believes he missed a chance for national prominence by allowing the two whistleblowers to be fired and sweeping the results of their investigations under the rug. Critics point out that PennMap is still in place even though TMAP has been discredited in Texas and other states.

In November 2005, USA Today quoted FDA Drug Safety Officer, Dr David Graham’s estimate that 62,000 Americans die each year from the off-label prescribing of atypicals. According to Mr Jones, this translates into nearly 10,000 deaths occurring in Pennsylvania during Governor Rendell’s first term.

During a congressional hearing last month, Dr Graham testified that the off-label use of atypicals to sedate people in nursing home kills roughly 15,000 people a year. Based on this estimate, Mr Jones says, about 2,400 Pennsylvania senior citizens died in the Governor’s first term.

“During this time,” Mr Jones reports, “Pennsylvania citizens, insurers and taxpayers paid in the neighborhood of one billion dollars for drugs proven to be no more effective, and far more deadly, than the older antipsychotic medications.”

Filed under: 2007, antipsychotics, AstraZeneca, Eli Lilly, Johnson and Johnson, RISPERDAL, Seroquel, settlement, Zyprexa

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

Evelyn Pringle June 17, 2006

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The gang behind TeenScreen, claims the survey can detect seven mental health disorders. The program’s Executive Director, Laurie Flynn, told a congressional committee on March 2, 2004, that in the screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality.”

Critics are outraged over TeenScreen. “The goal is to promote the patently false idea that we have a nation of children with undiagnosed mental disorders crying out for treatment,” according to Forcing Kids Into a Mental Health Ghetto, by Texas Congressman and physician, Ron Paul.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

According to Bloomberg News on April 20, 2006, as many as 5,000 new suits have been filed in state and federal courts and more are expected, attorneys for patients in California, Pennsylvania, Mississippi and Texas told Bloomberg.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Tracking the American Epidemic of Mental Illness – Part II

Evelyn Pringle June 7, 2010

Tax dollars are being used to fuel the American epidemic of mental illness by promoting the preemptive drugging of persons supposedly at risk of developing mental disorders, to the great benefit of the pharmaceutical industry.

In March 2010, the US Department of Health & Human Services Substance Abuse & Mental Health Service Administration Center for Mental Health Services announced $16.5 million in funding for “Mental Health Transformation Grants,” one of SAMHSA’s services grant programs.

“In order to complement but not duplicate the efforts of other CMHS programs, FY 2010 funding for MHTG will focus on services for adults with or at-risk for serious mental illnesses,” the agency noted.

Applications were required to implement evidence-based or best practices that would create or expand capacity to address one or more of five Strategic Initiatives, including: “Prevent mental illness through outreach, screening, and early interventions for adults with early signs of mental illness or who are at risk, and promote wellness through holistic treatment approaches.”

An evidence-based practice, or EBP, refers to approaches to prevention or treatment that are validated by some form of documented research evidence. As an example of a practice that could be implemented, SAMHSA listed under “Prevention and Wellness: Early Intervention,” the “Early Detection and Intervention for the Prevention of Psychosis Program (EDIPPP),” along with a link to its website http://www.changemymind.org/.

EDIPPP is a national program replicating the “Portland Identification and Early Referral,” or “PIER,” a treatment research program at the Main Medical Center, in Portland, Maine.

On a webpage for PIER on the Center’s Website, under “Project Overview,” it states: “The goals are to improve outcomes and prevent the onset of the psychotic phase of illnesses like Bipolar Disorder, Major Depression, and Schizophrenia.”

“This is the first program in the United States to identify the entire population of at risk young persons and offer them treatment,” PIER said in a September 26, 2005 press release.

EDIPPP was funded through a $14.4 million million grant for the “National Demonstration of Early Detection, Intervention and Prevention of Psychosis in Adolescents and Young Adults,” from the Robert Wood Johnson Foundation, and is “designed to prevent psychosis in teens and young adults,” according to an April 10, 2007, announcement on RWJF’s launch of the program.

“The national program is expanding PIER’s success during the past seven years in identifying and treating young people experiencing subtle and early symptoms that herald the onset of serious mental illness,” a November 2007 report in Behavioral Healthcare, by Dr James Maier, a research psychiatrist with PIER, notes.

EDIPPP works with people between the ages of 12 and 25, with an average age of persons entering the program between 15 and 16.

“Widespread dissemination of this early intervention model throughout the United States offers tremendous hope and optimism for combating some of the most devastating and costly illnesses that can afflict young people and their families,” Maier claims.

The RWJF grant set up additional EDIPPP sites in Sacramento, California; Salem, Oregon; Ypsilanti, Michigan; and Glen Oaks, New York. A site in Albuquerque, New Mexico was added in 2008.

RWJF also funds a booklet for professionals, on how to prevent mental illness with early detection titled, “Recognizing and Helping Young People at Risk for Psychosis: A Professional’s Guide,” which can be downloaded free off the internet.

From the start, PIER has always been primarily funded by RWJF, according to its website. However, on October 13, 2003, Mental Health Weekly reported that the program had received a $3.9 million grant from the National Institute of Mental Health, and a parallel $2 million grant from the Center for Mental Health Services intended for a related program in early identification of non-psychotic disabilities.

In Portland, young people typically are referred to PIER by high school guidance counselors, pediatricians, or other clinicians who attended presentations about PIER’s work, visited the PIER Website (http://www.preventmentalillness.org), and are familiar with the early warning symptoms that suggest the onset of a psychotic illness, according to the report in Behavioral Healthcare.

Mental Illness According to PIER

In a fact sheet posted to “Dispel the Myths,” the PIER website claims that, “Mental disorders are as easy to diagnose as asthma, diabetes, and cancer.”

“Treatments are effective 60%-80% of the time, success rates that meet or exceed success rates for cutting edge treatment for heart disease,” the sheet states.

“In many cases, PIER does use medications,” the Websites says. “We believe that some of the newer medications effectively improve thinking and combat early symptoms.”

“Research suggests these medications may have a protective effect against changes in the brain that cause mental illness,” it reports.

Under costs, it reads: “For now, services provided by PIER staff are supported by grants. However, if certain medications, medical tests, or neurological assessments are ordered, there will be a charge.”

The PIER program was founded in 2000, by Dr William McFarlane, and after 10 years in operation, on May 28, 2010, the ChangeMyMind website listed only two “case studies and impact stories that illustrate the effectiveness of the Early Detection and Intervention for the Prevention of Psychosis Program.”

Medicated for Life

Virtually every person entering the PIER program is prescribed antipsychotics, such as Risperdal or Invega, marketed by Johnson & Johnson, the parent company of the Robert Wood Johnson Foundation. These prescriptions are off-label because antipsychotics are not FDA approved to “prevent” mental illness in any age group.

An August 2008 article, by Charles Schmidt in Discover Magazine, highlighted the PIER program with a byline that stated: “A new mix of therapy and medication may stave off psychosis among teens at risk.”

Schmidt discussed the case of Camila (not her real name), who entered the program in September 2001, when she was 14. “Camila and her family stuck with PIER for the four-year treatment program, which ended formally in 2005, and still keep in touch with counselors there,” he reports.

However, “Camila’s health still hinges on antipsychotic medication,” Schmidt says. “In the summer of 2007 she went off the drugs for a spell and her strange feelings returned.”

He notes that her reliance on antipsychotics raises issues. “On the one hand, it shows that the threat of psychosis hasn’t really been removed, it’s just been held in check.”

“What we hope is that the benefits of treatment will be lifelong,” McFarlane says in the article. “We don’t have any empirical evidence to support that yet, but what we’ve seen is that young people who still haven’t converted to psychosis after about three years of our treatment don’t seem to be at much risk.”

While he suggests that over time, some patients may be able to go off medications, McFarlane acknowledges that PIER hasn’t developed a plan for managing that process, Schmidt reports.

“As to when or if they can go off medication, that’s hard to say,” he told Schmidt. “I think many of our patients don’t feel a need to stop; they certainly don’t feel oppressed by it. At a certain point it becomes a personal choice.”

A fortune can be made from these life-long antipsychotic customers. In April 2010, the price for one box of Invega, at a middle dose, was $1,373 at DrugStore.com. Risperdal went for $788 per 90 pills. The cost was $1,395 for 100 tablets of Abilify. Seroquel cost $997 per 100. One-hundred capsules of Geodon sold for $918 and Zyprexa cost $1,523 for a hundred 10mg pills.

In 2003, McFarlane told Mental Health Weekly that with about 3% of the population at risk for a serious mental illness, Greater Portland could expect about 75 young people to develop a disorder each year.

RWJF Front Group

The founder of RWJF, Robert Wood Johnson, was chairman of Johnson & Johnson for over 30 years, from 1932 to 1963, as a member of the drug maker’s founding family. Throughout the years, the majority of the Foundation’s money has come from investments in J&J stock. RWJF’s board of trustees has always been stacked with the drug company’s executives. For instance, current and past trustees have held positions at J&J such as President, CEO, Vice President, Chairman of the Board, and Treasurer, and have served along side another family heir on the board, Robert Wood Johnson IV.

RWJF is listed in a Medicaid fraud lawsuit, filed against J&J by whistleblower, Allen Jones, a former federal fraud investigator, and joined by the Texas attorney general, as providing funding for illegal marketing schemes to increase the off-label sales of Risperdal, including funding the development of the “Texas Medication Algorithm Project (TMAP),” which required doctors to prescribe the newest, most expensive antipsychotics, antidepressants, anticonvulsants, and ADHD drugs to patients covered by public programs, like Medicaid and Medicare, who were diagnosed with mental disorders, and a nearly identical set of child drugging guidelines known as the “Texas Children’s Medication Algorithm Project (CMAP).”

In addition to Risperdal and Invega, J&J also markets the ADHD drug Concerta, and Topamax, an anticonvulsant.

A May 11, 2005, report by RWJF on the results of the funding of TMAP grants totaling $2,389,581 to the University of Texas Southwestern Medical Center at Dallas and a grant of $353,747 to the Texas Department of Mental Health and Mental Retardation, describes the supposed “Problem,” that led to the creation of the TMAP drugging guidelines as:

“In the 1980’s and 1990’s, as pharmaceutical companies began producing new and more efficacious medications to treat people with serious mental disorders such as depression, bipolar disorder, and schizophrenia, the question arose of how to choose the most appropriate treatment options. Concerns about wide variation in prescribing practices by physicians and complaints from consumer advocates about the negative consequences of this variation spurred the creation of evidence-based guidelines and medication treatment algorithms.”

The “Contacts” for the grants listed in the report, were Dr A John Rush, for the University, and Dr Steven Shon for the state of Texas. Shon was fired in October 2006, after the Texas attorney general determined that J&J had improperly influenced him to make Risperdal a preferred drug on TMAP. In 2008, Rush was added to a list of psychiatric academics who failed to disclose all the payments they received from drug companies, by Senator Charles Grassley, as part of an investigation conducted on behalf of the US Senate Finance Committee, which oversees Medicaid and Medicare spending.

As a main component of the off-label marketing schemes, the lawsuits against the antipsychotic makers allege that the drug companies “seeded” the medical literature with reports and papers purporting to be written by “experts” when they were actually ghostwritten with the names of experts attached after the fact.

In its report on the TMAP grant results, RWJF boasts that: “More than 50 articles on the Texas Medication Algorithm Project have appeared in the Journal of Clinical Psychiatry, Psychiatry Research, Managed Care, Health Services Research, Journal of the American Academy of Child and Adolescent Psychiatry and other peer-reviewed journals.”

“Over the next two years, Project Directors Rush and Shon and their colleagues plan to publish additional articles on other areas of interest,” the report said.

On August 18, 2008, a Dallas Morning News headline read: “Conflict of interest fears halt children’s mental health project,” in reference to the Children’s Medication Algorithm Project. “A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News wrote.

To date, four of the five atypical makers have settled fraud charges involving the illegal off-label marketing of antipsychotics, including for use with children. Eli Lilly paid $1.4 billion for Zyprexa, Bristol-Myers Squibb’s fine was $515 million for Abilify, Pfizer paid $301 for Geodon, and AstraZeneca just forked out $520 million for Seroquel.

But the fines are merely chocked up to the cost of doing business. For instance, although AstraZeneca paid a whopping $520 million fine, Seroquel had sales of $4.9 billion in 2009, with more than half coming from the US. Overall, antipsychotics were the top-earning class of drugs in the US, in both 2008 and 2009, with sales of $14.6 billion in 2009, according to IMS Health.

J&J is the only atypical maker that has not settled the off-label marketing charges against it – yet. However, two units of J&J “will pay more than $81 million to resolve criminal and civil claims over illegal promotion of the epilepsy drug Topamax,” according to Bloomberg news on April 29, 2010.

Also, over the past 2 months, J&J’s McNeil division has recalled over 40 varieties of child and baby medications after the FDA found massive safety and manufacturing violations at a plant in Fort Washington, Pennsylvania, including formulations of Tylenol, Motrin, Zyrtec and Benadryl. The FDA also found problems with “strength, quality and purity.”

The FDA’s inspection report notes that J&J received about 46 consumer complaints “regarding foreign materials, black or dark specks [in their drugs] from June 2009 to April 2010.” J&J had knowledge of problems since May 2009, which means it was allowing children and infants to ingest potentially poisonous drugs for a year before the product recall took place.

Time Magazine as Promoter

On June 22, 2009, the RWJF website posted a link to download the full text of an article in Time Magazine, by John Cloud titled, “Staying Sane May Be Easier Than You Think,” who reported: “The most exciting research in mental health today involves not how to treat mental illness but how to prevent it in the first place.”

“In fact,” Cloud said, “many mental illnesses — even those like schizophrenia that have demonstrable genetic origins — can be stopped or at least contained before they start.”

“This isn’t wishful thinking but hard science,” he claimed.

The article discussed a report by the National Academics, “an organization of experts who investigate science for the Federal Government,” nearly two years in the making, “on how to prevent mental, emotional and behavioral disorders.” A quick check found one of the sponsors of the National Academies to be RWJF.

“The report concludes that pre-empting such disorders requires two kinds of interventions,” Cloud said, “first, because genes play so important a role in mental illness, we need to ensure that close relatives (particularly children) of those with mental disorders have access to rigorous screening programs.”

“Second,” he noted, “we must offer treatment to people who have already shown symptoms of illness (say, a tendency to brood and see the world without optimism) but don’t meet the diagnostic criteria for a full-scale mental illness (in this case, depression).”

“Some prevention programs even prescribe psychiatric medications, including antipsychotics and antidepressants, to people who aren’t technically psychotic or depressed,” Time reported.

“This is a big concern,” Joseph Rogers, founder of the Philadelphia-based National Mental Health Consumers’ Self-Help Clearinghouse told Cloud. “Because, gee, if you miss, you can really do more harm with some of these drugs than good.”

“But those who contributed to the National Academies report say preventing the suffering of people with mental illness is worth the risk of some false positives, partly because of the enormous cost of treating mental illness after it’s struck,” Cloud reported.

The article profiled PIER and McFarlane, who was described as “one of the world’s top authorities on preventing mental illness.”

According to Time, the “National Institute of Mental Health is funding a trial of McFarlane’s work, and while he is still writing up his data for publication, his anecdotal results are promising: most of the kids are so far avoiding a first psychotic episode.”

Preemptive Drugging Unsupported

In a 2008 paper titled, Atypical Antipsychotic Agents For the Schizophrenia Prodrome: Not a Clear First Choice,” published in the “International Journal of Risk & Safety in Medicine,” Dr Stefan Kruszewski, a psychiatrist, and Dr Richard Paczynski, a neurologist, both from Harrisburg, Pennsylvania, explain that, “Pharmacologic intervention at the earliest stages of suspected psychotic illness is an intuitively appealing concept and a logical extension of the current approach to many other diseases of the central nervous system.”

“However,” they report, “a critical analysis of the results of structured clinical investigations which have explored the use of ATAPs for new-onset psychotic symptoms raises safety concerns and does not support pre-medication in this setting as a preventive strategy.”

“Over the past several years,” the paper states, “a voice has emerged in the international psychiatric community recommending early prescription of the atypical antipsychotic agents (ATAPs) for adolescents and young adults who appear to show signs consistent with a schizophrenia prodrome. Early use is predicated on the possibility that ATAPs may prevent progression to full-blown psychotic illness in this high-risk population. “

“This trend has been encouraged despite a paucity of data which clearly support the effectiveness of these agents for this indication, and despite evidence of adverse side effects including,” the authors note.

These circumstances prompted their literature review, “focusing on the five published studies that have explicitly addressed the preventative efficacy of the most widely prescribed ATAPs in structured (i.e., non-anecdotal) clinical settings.”

In the summary and conclusion section of the paper, the authors report that the results from the available controlled trials reviewed are in line with several of the conclusions of the naturalistic study by Cornblatt et al. “That is, early prescription of ATAPs to adolescents and young adults seeking medical attention for prodromal psychotic symptoms is associated with high rates of medication non-adherence.”

“Additionally,” they say, “the introduction of ATAPs was not associated with reduction in the rate of conversion to formal psychosis beyond that explainable by chance and/or the introduction of bias secondary to baseline imbalances, inadequate blinding or even differential psychosocial supports.”

“We suggest caution in making any assumptions that justify changes in prescription-writing behavior when it involves patients who are at high risk for developing long-term psychotic illnesses but have never demonstrated sustained psychosis (psychotic illness by DSM-IV criteria),” Kruszewski and Paczynski advise.

“This would include but is not limited to persons with suspected schizophrenia prodrome,” they add.

“Even in the hands of experienced investigators using detailed screening protocols in controlled settings, only one-quarter to one-third of high-risk patients converted to full-blown psychosis,” they report.

“Consequently,” they warn, “if early use of ATAPs continues as a quasi-standard of care for new-onset psychotic symptoms, a large majority of these often young individuals will be exposed unnecessarily to poorly defined but likely substantial risks, including but not limited to obesity, hyperlipidemia, metabolic syndrome, increased rates of type II diabetes mellitus and extrapyramidal syndromes, both acute and chronic.”

“Considerations of safety must come first when the preventative efficacy of these agents remains so poorly defined,” they conclude.

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 2010, antipsychotics, drugging children, EDIPPP, front groups, Johnson and Johnson, PIER, preemptive drugging, prodome, RISPERDAL, Robert Wood Johnson Foundation, RWJF, SAMHSA, TMAP

Drug Companies Still Peddling Risperdal and Zyprexa For Off-Label Use – June 19, 2006


Image: i.bnet.com

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

First published June 19, 2006

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The gang behind TeenScreen, claims the survey can detect seven mental health disorders. The program’s Executive Director, Laurie Flynn, told a congressional committee on March 2, 2004, that in the screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality.”

Critics are outraged over TeenScreen. “The goal is to promote the patently false idea that we have a nation of children with undiagnosed mental disorders crying out for treatment,” according to Forcing Kids Into a Mental Health Ghetto, by Texas Congressman and physician, Ron Paul.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

According to Bloomberg News on April 20, 2006, as many as 5,000 new suits have been filed in state and federal courts and more are expected, attorneys for patients in California, Pennsylvania, Mississippi and Texas told Bloomberg.

The lawsuits allege that Lilly knew of the risks associated with Zyprexa but did not warn doctors and consumers. Many of the patients in the new lawsuits claim they took Zyprexa without knowing the risks because Lilly promoted the drug to doctors as an off-label treatment for illnesses other than schizophrenia and bipolar disorder.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(1) AG sues drug company for fraud, The Record, March 23, 2006

(2) Off-label drugs take their toll, November 2, 2003, Knight Ridder Newspapers

(3) In Diabetes, One More Burden for the Mentally Ill, New York Times, June 12, 2006

(4) Use of Antipsychotics by the Young Rose Fivefold, New York Times, June 6, 2006

(5) New anti-psychotic drugs carry risks for children, USA Today, May 1, 2006

(6) Polypharmacy Control Is Key for Psych Rx Savings Under Part D, March 17, 2006, Drug Benefit News, biweekly news, data and business strategies for health plans, PBMs and pharmaceutical companies.

(7) Antipsychotic Drug Use Growing Fastest Among Children, Medco Health Press Release, May 2, 2006

(8) Lilly Faces New Lawsuits Claiming Excess Marketing of Zyprexa, Bloomberg News, April 20, 2006

EVELYN PRINGLE
Award Winning Investigative Journalist and Researcher

Filed under: 2006, drugging children, RISPERDAL, TeenScreen, Zyprexa

Kids Dying From Off-Label Use Of Antipsychotics – May 8, 2006


Image: topnews.in

Kids Dying From Off-Label Use Of Antipsychotics

First published May 8, 2006

A recent USA Today sponsored review of the FDA database from 2000 to 2004 found at least 45 deaths in children under 18 with atypical antipsychotics listed as the “primary suspect,” and 1,328 reports of other serious side effects, some life-threatening.

The FDA’s adverse event reporting system is known to capture only between 1% to 10% of side effects and deaths, which means the true numbers are actually much higher.

Among the 45 deaths, discussed in the May 2, 2006, USA article, at least six were related to diabetes, and other causes ranged from heart and pulmonary problems to choking, liver failure and suicide.

An 8-year-old boy died of cardiac arrest. A 15-year-old boy died of an overdose and a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin. The youngest child was 4, with symptoms that indicated diabetes complications.

The most common adverse reactions reported were:

A condition known as dystonia, which produces involuntary, and often painful muscle spasms, was the most common side effect with 103 cases.

Tremors, weight gain, sedation, and other neurological effects with symptoms that varied from slight twitching to full-blown body jerking.

The neuroleptic malignant syndrome showed up in 41 children, and was the most troubling side effect, according to child psychiatrist Joseph Penn, of Bradley Hospital and Brown University School of Medicine, because it can kill within 24 hours.

Atypical antipsychotics are a relatively new class of drugs approved by the FDA for the treatment of adult schizophrenia and bipolar disorder. None of the drugs that include Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon, are approved for children, but doctors continue to prescribe the drugs off-label for unapproved uses.

Even thought the package inserts for atypicals say their safety and effectiveness with children have not been established, a skyrocketing number of prescriptions are being written for children diagnosed with attention deficit disorder or other behavioral problems, according to a study in the March-April 2006, edition of the journal Ambulatory Pediatrics.

This study found that the number of children prescribed antipsychotic drugs had increased five-fold between 1995 and 2002, to an estimated 2.5 million, which represents an increase from 8.6 for every 1,000 children in the mid-1990s, to nearly 40 in every of 1,000 in 2002.

The researchers analyzed data on children with an average age of 13, who were involved in annual national health surveys involving prescriptions issued during 119,752 doctor visits, and determined that over half of the prescriptions were written for attention deficit or other non-psychotic conditions.

The findings are troublesome “because it looks like these medications are being used for large numbers of children in a setting where we don’t know if they work,” said the study’s lead author, Dr William Cooper, a pediatrician at Vanderbilt Children’s Hospital in Nashville, TN.

Dr Cooper and his colleagues were among the first to investigate the increase in antipsychotic use with children and teens, in a study published in the summer of 2004, that reported that prescriptions for atypicals had doubled among Tennessee children on Medicaid between 1996 and 2001.

Back then they found that 43% of prescriptions were written for ADHD, or a related disorder as the primary diagnosis, and 14% were written for bipolar disorder, and 9% for schizophrenia or other psychotic conditions.

In a later nationwide study, researchers concluded that 6 million prescriptions for atypicals were written for children between 1995 and 2002, and again found that a large percentage of the prescriptions were written with ADHD as the primary diagnosis.

“The bottom line is that we are seeing a huge increase in the use of these medications among children, and we are not sure if they work or if they are safe,” Cooper told WebMD. “These drugs have not been tested for many of the indications that they are being used for.”

Even more disturbing finding was recently reported in a study led by Oregon Health & Science University professor, David Pollack, that revealed that 246 preschool children under the age of 5, who were enrolled in the state-sponsored Medicaid program, were receiving antipsychotic or antidepressant medications.

The review of Medicaid records, reported in the April 2006, Oregon Health News, found that 41% of the preschoolers were prescribed psychiatric drugs for ADD.

Experts say the prospect of children under 5, receiving psychiatric drugs intended for adults is alarming. Also alarming was the finding that about 50% the prescriptions were written by primary care providers and not psychiatrists.

The study was a collaboration by Oregon’s department of human services, Medicaid program, and the Oregon State University College of Pharmacy.

An equally disturbing report was published in the April 25, 2005, Columbus Dispatch on an investigation of state Medicaid records that found 18 babies ranging from newborn to 3 years-old in Ohio had been prescribed antipsychotic drugs in July 2004.

In another analysis of privately insured children, by the pharmacy benefit manager, Medco Health Solutions, conducted for USA Today, the rate of children, 19 and under, with at least one atypical prescription had increased 80% in the four years from 2001 to 2005. This analysis did not include any children covered by government programs like Medicaid.

The study noted that atypical use among girls was much greater than with boys. The number of girls taking the drugs grew 103% from 2001 to 2005, compared to a 61% increase with boys.

The rate of children treated with atypicals “is growing dramatically faster than the rate for adults,” said Robert Epstein, chief medical officer for Medco, in a press release.

“Doctors need to be judicious when prescribing antipsychotic drugs to children,” Epstein warned. “There is evidence that the risk of diabetes and metabolic disorders from using atypical antipsychotics could be much more severe for pediatric patients than adults,” he said.

“The use of these drugs,” Dr Epstein warned, “can have the pediatric patient trading a behavioral condition for a lifelong metabolic condition that can lead to significant health complications.”

Critics say the increased use of atypicals with children is most troubling because the dangers associated with the drugs, in adults and children, has been evident in the scientific literature since before they came on the market.

In the book, Mad In America, award winning author, Robert Whitaker, reports that one out of every 145 subjects who entered clinical trials for Zyprexa, Risperdal, Seroquel, and Serdolect died. By using the Freedom of Information Act to gain access to FDA data on the drug trials for the atypicals he determined:

(1) One in every 145 patients died but the deaths were not mentioned in the scientific literature.

(2) The trials were structured to favor the atypicals and most of the reports were discounted by the FDA as being biased.

(3) One in every thirty-five patients in Risperdal trials experienced a serious adverse event, defined by the FDA as a life threatening or one that required hospitalization.

(4) The atypicals did not demonstrate superior effectiveness or safety over the older antipsychotics.

In addition, persons on atypicals have been found to commit suicide 2 to five times more often than schizophrenics in general. According to Whitaker, “researchers in Ireland reported in 2003 that since the introduction of the atypical antipsychotics, the death rate among people with schizophrenia has doubled.”

For instance, in October 2004, researchers from the Johns Hopkins Children’s Center reported that atypicals were found to trigger insulin resistance in children, a condition that increases the risk of developing type-2 diabetes and heart disease later in life.

Results of the study were presented at October 20, 2004, annual meeting of the American Academy of Child and Adolescent Psychiatry in Washington, DC.

In this study, the research team evaluated 11 children, some overweight and others obese, who gained significant amounts of weight while taking the drugs. Weight gain is a common side effect of the drugs, and is one of the factors that can contribute to insulin resistance.

Insulin resistance is said to occur when muscle, fat, and liver cells do not properly use insulin, which is produced by the pancreas to help cells absorb glucose and provide energy.

When resistance occurs, the pancreas tries to keep up with the demand for insulin by producing more until it eventually cannot keep up with the body’s need for insulin, and then excess glucose builds up in the bloodstream which can lead to an increased risk of developing type-2 diabetes, heart disease, and stroke.

All six children in the study who were on moderate or high doses of one of the atypicals, and three out of 5 children who were on low doses, developed symptoms of insulin resistance.

The evidence in the trial indicating the condition included hypertension, high levels of triglycerides, increased levels of protein in the urine, and low levels of high density lipoprotein cholesterol.

“The insulin resistance seen in these children was greater than what would be expected from weight gain alone, suggesting there is a factor distinct from excess weight that directly induces insulin resistance,” according to the study’s lead author, Mark Riddle, MD, director of the division of child and adolescent psychiatry at the Children’s Center.

Basically to find out how the new atypicals worked in comparison to each other and to determine whether the drugs were worth the cost, the National Institute of Mental Health (NIMH) decided to fund an 18 month study titled, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE).

The results of the study were published in the September 22, 2005, New England Journal of Medicine and revealed that the drugs were barely more effective than no drugs at all.

The study enrolled 1,500 schizophrenic patients from 27 medical centers across the US. Neither the patients nor the doctors knew whether a patient was getting Zyprexa, Seroquel, Risperdal, Geodon, or Trilafon.

The scientists included Trilafon to represent the older generation of antipsychotic drugs.

$44 million later, the CATIE report concluded that the new atypicals “have no substantial advantage” over the old ones.

While Zyprexa turned out to be the most effective, it also had the greatest number of side effects.

The second most effective drug was Trilafon which stunned researchers. “The biggest surprise was that the oldest medication was comparable to at least three of the new medications and not much worse than Zyprexa,” said Dr Jeffrey Lieberman, MD, who led the study.

Scientists involved in designing the study debated on whether to even include Trilafon, according to researcher, Robert Rosenheck, MD. “Many of us thought the question was decided and the old drugs were of no value,” he said in a news conference.

Researcher, Robert Freedman, MD from the University of Colorado, published an editorial to accompany the report in the NEJM.

“No drug provided the majority of patients a treatment that lasted the full 18 months of the study,” he wrote. “Only 36% of the patients receiving the most effective drug completed the trial,” Dr Freedman said.

In the end, 74% of patients elected to seek some other treatment rather than stay on their assigned medication. “The results could be viewed as discouraging,” Dr Freedman wrote.

In what outraged critics are calling a blatant tax dollar funded marketing scheme, on May 1, 2006, the New York Times, revealed that “psychiatric researchers have been experimenting with a bold and controversial treatment strategy: they are prescribing drugs to young people at risk for schizophrenia who have not yet developed the full-blown disorder.”

The findings from the trial, published in the May 2006 American Journal of Psychiatry, “suggest that this preventive approach is more difficult to put into effect — and more treacherous — than scientists had hoped,” the NYTs says.

The study was co-funded by Eli Lilly and the National Institute of Mental Health and involved 60 patients, mostly adolescents, who supposedly scored high on a scale that assesses the risk for psychosis. The scale rates the severity of over a dozen symptoms, that include categories such as grandiosity, suspiciousness, and bizarre thoughts.

From 20 to 45% of people who score high will go on to develop full-blown psychosis, in which the symptoms become extreme, researchers claim.

The trail subjects were divided into 2 groups, with one group receiving drugs and the other placebos.

In the first year of what was slated to be a 2-year trial, five of the 31 patients on medication developed full-blown psychosis, compared to 11 of the 29 subject on placebos.

However, by the end of the first year, more than two-thirds of the patients had quit, making it impossible to interpret any differences between the 2 groups.

The report said that some subjects dropped out without explaining why; others moved; and 10 quit because they either felt the drug was not helping, could not make the appointments or did not like the side effects.

The only undisputable result was that patients taking medication gained an average of 20 pounds, once again verifying a side effect that has been documented for 15 years.

The prices charged for these drugs are over the top and their increased use, along with a few other types of psychiatric drugs, is in large part responsible for the escalating prescription drug costs.

The Medco Health Solution study determined that since 2001, antipsychotic costs for children have increased 196%, or nearly tripled, due to the increase in prescriptions written and the use of the new atypicals with children 97% of the time, rather than the older drugs that sell for only a fraction of prices charged for atypicals

Overall, in 2002, the total sales of antypicals to patients of all ages reached $6.4 billion, making them the fourth-highest-selling class of drugs in the US, according to IMS Health, a company that tracks drug sales.

Two years later in 2004, total sales had jumped more than $2 billion to $8.8 billion, with $2.4 billion of that amount paid by state Medicaid funds, according to the May/June 2005 issue of Mother Jones Magazine.

Schizophrenia drugs account for the biggest share of the $39 billion that states spend each year on prescription drugs.

On October 23, 2005, the San Francisco Chronicle reported that nationwide, “Medicaid programs purchase an estimated 60 to 75 percent of antipsychotic drugs.”

The highest expenditure for California’s Medicaid, was Zyprexa at close to $250 million for the year that ended June 2005. Risperdal and Seroquel, ranked 2nd and 4th in the list of high cost drugs funded by Medicaid.

The costliest per month is Zyprexa, at an average cost of $399.26, according to the California Department of Health Services.

In 2002, the Kentucky Medicaid program ended up with a $230 million deficit and the $36 million bill for Zyprexa was the state’s largest per drug expense.

Judging by third quarter earning reports for 2005, fifteen years of negative studies have had no effect on sales that show:

Seroquel, $706 million, up 32%

Abilify, $206 million, up 58%

Geodon, $148 million, up 18%

Zyprexa, $1.035 billion, up 1%

In a disgusting twist of fate, Zyprexa’s maker, Eli Lilly’s diabetes drugs earned $653 million, up 13% when Zyprexa has consistently been found to be most likely drug to cause weight gain and high blood sugar leading to diabetes.

Risperdal is still Johnson & Johnson’s top-selling drug, and had sales of $916 million in the 3rd quarter, up 23% from the same period a year earlier.

This great news for J&J but translates into 916 fatalities for Risperdal patients, according to estimates by Allen Jones, a former investigator in the Pennsylvania Office of the Inspector General, who says, “my best effort at correlating dollars spent with deaths from drug side effects suggests that people may be dying from side effects from the schizophrenia drugs alone at the rate of at least one death for each one million dollars spent on these drugs.”

“The actual numbers may reflect a much higher death rate,” he warns.

However, experts are predicting that drug company profits might soon take a dive in light of a study published in the September 2005 New England Journal of Medicine, that found that only one atypical worked slightly better than the 40-year-old antipsychotic drug, perphenazine, which only costs about $1.50 a day compared to 10 times that amount for the atypicals.

It is estimated that the Medicaid program overall could save as much as $5.5 billion annually on by switching to perphenazine.

Filed under: 2006, antipsychotics, drugging children, Geodon, RISPERDAL, Seroqel, Zyprexa

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    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…
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    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.
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    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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