Evelyn Pringle August 30, 2007
On August 21, 2007, the Associated Press reported that drug companies spend a lot of money on the members of Minnesota advisory panels who help select the drugs which are to be used by patients covered by Medicaid.
The news agency's review of financial disclosure records in Minnesota found that a doctor and a pharmacist on the 8-member panel simultaneously received large checks from drug companies for speaking about their products.
According to the report, Minneapolis psychiatrist John Simon, appointed to the panel in 2004, earned $354,700 from drug makers that included Eli Lilly and AstraZeneca, from 2004 to 2006, in honoraria, speaker and consulting fees, as well as other payments ranging from $500 to $93,012.
The records also showed that Robert Straka, a University of Minnesota pharmacy professor, was paid $78,000 by drug companies while he served on the panel from 2000 to 2006. He told the Associated Press that he was paid for "educational talks" and that he routinely discloses his ties with drug companies and did so as a panel member, both verbally and in writing.
But according to information obtained with a public records request by the AP, there is no indication that Mr Straka made any such disclosures in meeting minutes dating back to February 2001, and other panel members and staff interviewed by the AP could not remember Mr Straka making any such disclosures either.
The Associated Press reported that roughly a third of the drugs on Minnesota's preferred drug list were sold by companies which paid Mr Simon or Mr Straka, but the news agency could not track any link between the payments and their votes because the minutes from the advisory panel meetings did not record how the 8 members voted.
The top-selling drugs prescribed to Minnesota Medicaid patients for the years 2000 through 2006 included the atypical antipsychotic drugs Zyprexa, marketed by Eli Lilly; Seroquel, sold by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.
These drugs were originally FDA-approved for the limited use of treating adults with schizophrenia or the manic phase of bipolar disorder. However, the massive over-prescribing of this enormously expensive class of drugs for unapproved uses has caused many states to remove them from the Medicaid preferred drugs lists and requires doctors to obtain prior authorization before prescribing them to Medicaid patients.
In fact, roughly 10 states are now suing several atypical makers for Medicaid fraud to recoup the cost of purchasing the antipsychotics prescribed off-label to Medicaid patients and also to recover the money paid for medical care of the persons injured by the drugs.
The lawsuits allege that the drug makers illegally influenced doctors to prescribe the drugs off-label to patients of all ages, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, dementia, and many other unapproved indications, and concealed the adverse effects associated with the drugs.
The atypical makers are also facing tens of thousands of lawsuits filed by patients, private insurance carriers and company shareholders for similar allegations.
According to Lilly's August 6, 2007, SEC filing, since August 2006, Lilly has received civil investigative demands or subpoenas from a number of states. "Most of these requests are now part of a multistate investigative effort being coordinated by an executive committee of attorneys general," the filing states.
"We are aware that approximately 30 states," Lilly wrote, "are participating in this joint effort, and it is possible that additional states will join the investigation."
The filing notes that the attorneys general are seeking a broad range of Zyprexa documents, "including documents relating to sales, marketing and promotional practices, and remuneration of health care providers."
Presumably, that would also include the "remuneration" of Minnesota shrinks like Dr Simon. According to the August 27, 2007, Pioneer Press, since 2002, Dr Simon has received more than $570,000 from six drug makers, with most of the money coming from Eli Lilly, "whose antipsychotic drug Zyprexa is the most costly each year for Minnesota's fee-for-service health program for the poor and disabled," the article states.
In fact, Lilly's disclosure records for 2004 show payments to Dr Simon totaling a whopping $91,854.95 in that one year, and he also received another couple grand from Seroquel maker AstraZeneca.
Dr Simon told the Pioneer Press that companies pay him to speak about their drugs at conferences and clinics or about the conditions that are treated with the drugs. "Most of the psychiatrists who are really good," he said, "have ties to industry."
Whether Dr Simon is a "really good" psychiatrist is certainly open to debate. In 1997, the state medical board made him complete a clinical training program and issued a report which said that Dr Simon, "frequently makes abrupt and drastic changes in type and dosage of medication which seem erratic, not well considered and poorly integrated with nonmedication strategies."
The board also noted that Dr Simon prescribed addictive drugs to addicts and failed to stop giving medicines to patients when they were suffering severe drug side effects. He said in an interview with the Times that the board's action was a learning experience and that drug makers continued to hire him to speak because he was respected by his peers.
For years, Dr Simon reportedly shared an office with another "really good" psychiatrist by the name of Dr Faruk Abuzzahab. On June 3, 2007, Gardiner Harris and Janet Roberts published a story in the New York Times with the headline: "After Sanctions, Doctors Get Drug Company Pay," and stated:
A decade ago, the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a "reckless, if not willful, disregard" for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.
Over the past 20 years, this "really good" psychiatrist has repeatedly prescribed narcotics and other controlled substances to addicts and prescribed narcotics to pregnant women, one of whom delivered a baby prematurely that died, the board found.
The Times reports that separately, in 1979 and 1984, the FDA concluded that Dr Abuzzahab had violated the protocols of every study that the agency audited and that he reported inaccurate data to drug makers.
The FDA said he routinely oversaw 4 to 8 trials at the same time, moved patients from one study to another, gave experimental drugs to patients at their first consultation and once hospitalized a patient for the sole purpose of enrolling him in a study.
As recently as June 2006, the medical board criticized Dr Abuzzahab once again for writing prescriptions for narcotics and this time to patients he knew were using false names, according to the Times.
All that said, Dr Abuzzahab told the Times that he has helped study many popular psychiatric drugs, including Lilly's Zyprexa and Prozac, Janssen's Risperdal, AstraZeneca's Seroquel, Glaxo's Paxil and Pfizer's Zoloft.
A review of the Minnesota disclosure records for 2004 show that the drug makers apparently thought it was beneficial to keep paying big bucks to Dr Abuzzahab. Glaxo paid him $1,000, Pfizer gave him $750, and Wyeth forked over $18,084, in that year alone.
In 2003, psychiatrist Dr Ronald Hardrict pleaded guilty to Medicaid fraud. But a little charge like fraud apparently did not effect this Minnesota psychiatrist's earning power either. The very next year, disclosure records for 2004 show Risperdal maker Janssen paid him $10,000; Seroquel maker AstraZeneca gave $1,250; Abbott Labs paid him over $7500; Glaxo paid $1,500, and Wyeth forked over $8,846.
In reviewing the Minnesota disclosure records for 2004, the name Dr Dean Knudson kept popping up. A September 2004 Newsletter from the Ada Canyon Medical Education Consortium listed Dr Knudson as an associate professor of psychiatry at the University of Minnesota Medical School.
He must be a "really good" psychiatrist, too, because in 2004 alone, Lilly paid him close to $37,000; he earned nearly $2,750 from Pfizer; Seroquel maker AstraZeneca paid him $6,700; Janssen forked over $3750; Wyeth paid him $11,632, and he received $2,082 from Abbott. Lilly's 2003 forms also show another $8,740 paid to Dr Knudson.
The newsletter showed that Dr Knudson was paid to give educational presentations on dementia. On October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia raised their risk of death.
For the study, the researchers pooled the results of 15 studies on the atypicals Zyprexa, Risperdal, Seroquel and Abilify and among more than 5,000 dementia patients, those taking any of the four drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.
Another name that jumps out in the 2004 disclosure records is Dr David Adson. According to the August 20, 2007, Pioneer Press, Dr Adson, of the University of Minnesota, also has a state advisory role as the clinical leader of a program funded by Lilly and provided free of charge to Minnesota, which notifies doctors when their prescriptions for psychiatric drugs are out of line with clinical standards.
Although the program is funded by Lilly, it is supposedly run by an independent company called Comprehensive NeuroScience, Inc. All totaled, 20 states have contracts with CNS to identify doctors "who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness," according to the Press.
Critics say the program is actually a scam set up with state policy makers to make sure the expensive psychiatric drugs remain on the Medicaid covered drug lists instead of being placed on the lists that require prior authorization.
Ben Hansen, a member of the Michigan Department of Community Health Recipient Rights Advisory Committee, has been investigating the atypical makers' involvement in the Medicaid programs in Michigan and other states and says that none of the states with CNS contracts require prior authorization for the atypical drugs.
Mr Hansen published some of the results of his investigation in the Spring 2007 Newsletter of the International Center for the Study of Psychiatry and Psychology. By using the FOIA, Mr Hansen says he has obtained nearly a thousand pages of documents which show that Medicaid is being "milked like a huge cash cow."
According to Allen Jones, a former Medicaid fraud investigator, the long list of corporate sponsors for CNS includes: AstraZeneca, Janssen, Bristol-Myers, Pfizer, Lilly and Glaxo.
Back in 2002, Mr Jones found that Janssen was using CNS to funnel payments to state officials who controlled the Medicaid preferred drug lists in Pennsylvania to ensure that Risperdal would be on the list.
For his part, the leader of the Minnesota CNS program, Dr Adson, was paid $5,200 by AstraZeneca, Glaxo shows $331,947 going to him, and Pfizer gave him $1,000, in 2004 alone.
Also, in 2006, Dr Adson received $83,325 from AstraZeneca and roughly $6,100 from Bristol-Myers, according to a compilation of disclosure forms by the Pioneer Press and the watchdog group Public Citizen.
Showing posts with label TMAP. Show all posts
Showing posts with label TMAP. Show all posts
Sunday, August 8, 2010
Psychotropic Drug Makers Bankroll Prescribing Shrinks Part II
Evelyn Pringle September 2, 2007
Influence peddling in the field of psychiatry is out of control. An analysis of Minnesota disclosure records by the Pioneer Press and the consumer watchdog group Public Citizen shows that, between 2002 and 2006, 187 Minnesota doctors received payments from drug companies worth a grand total of $7.38 million.
No other field of medicine even comes close to that amount. The next highest specialty was neurology, with 99 doctors receiving $2.89 million, according to the analysis.
In psychiatry, drug makers underwrite decision makers at every level of care, according to a May 10, 2007, report by Gardiner Harris in the New York Times. "They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow," Mr Harris states.
He determined that, between 2000 and 2005, payments to Minnesota psychiatrists increased more than six-fold. The Times also analyzed Minnesota Medicaid records, and the report provides details on how the financial relationships between doctors and drug makers have played a major role in the growing use of atypical antipsychotics with children.
The drugs include Zyprexa, marketed by Eli Lilly; Seroquel, by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.
The drugs are the most powerful psychiatric drugs on the market and were FDA-approved only to treat adults with schizophrenia or adults in the manic phase of bipolar disorder.
Over the past three years, every atypical maker has come under fire for influencing doctors to prescribe the drugs off-label to children for uses never approved by the FDA, and they are all currently involved in litigation related to the illegal promotion and sales of the drugs.
A study at Columbia University on the use of antipsychotics with children found that only a small percentage of the kids on the drugs had psychotic disorders and that, most of the time, the drugs were prescribed to treat mood disorders, depression, anxiety and ADHD.
Mr Harris reports that the Minnesota psychiatrists who received the most money from the drug's makers tended to prescribe them to kids the most often. On average, psychiatrists who received at least $5,000 between 2000 to 2005 appeared to have written 3 times as many prescriptions for kids as psychiatrists who received less or no money, the Times notes.
The rising Medicaid costs for atypicals also coincides with the rising payments to doctors. For instance, Minnesota Medicaid spent roughly $521,000 in 2000 on antipsychotics for children; but in 2005, the cost was more than $7 million, or a 14-fold increase.
In June 2007, Vermont officials revealed that disclosure records in that state showed payments to psychiatrists had more than doubled in one year, from an average of $20,835 in 2005, to an average $45,692 in 2005. There, too, antipsychotics were among the highest Medicaid drug expense.
The drug makers have shrinks in their pockets all over the country. However, only 3 states, Minnesota, Vermont and Maine, have laws that require companies to disclose their payments.
The media's recent reporting that members of a Minnesota advisory panel who decide which drugs will be covered by the state's Medicaid program are on the take, adds a new chapter to an old book. This same scam has been used in states all over the country since the late 1990's, and if not for two relentless fraud investigators from Pennsylvania, the fact that the formulary committees are bought and paid for by the pharmaceutical industry might have remained a secret for all time.
The fact that drug makers were bribing state policy makers and members of advisory panels with the ultimate goal of capturing the lucrative Medicaid customer base to increase the sale of psychiatric drugs was first discovered several years ago by Allen Jones, while he was a federal fraud investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations, and Dr Stefan Kruszewski, a pediatric psychiatrist by trade, who was hired by the Pennsylvania Department of Public Welfare to review the quality of care provided to persons covered by state programs.
According to Mr Jones, "the pharmaceutical industry has systematically infiltrated the mental health service delivery system of this nation."
"The situation uncovered in Minnesota," he says, "will be exposed in every state that demonstrates the political will to force transparency through full disclosure of industry payments to decision makers."
"Thinly veiled bribery of public officials by the pharmaceutical industry is a pervasive and deeply rooted problem," he warns.
During his investigation in Pennsylvania, Mr Jones found a drug money trail to key policy officials who controlled the Medicaid preferred drug list in that state, which eventually led him to Texas and an elaborate scheme that involved influential psychiatrists, including many who served as professors at Texas universities, and state policy officials who developed the preferred drug list known as the "Texas Medication Algorithm Project (TMAP)".
Mr Jones calls the Texas panel the "most transparent example" of industry influence, because all of the project directors had financial ties to the drug makers. It was put into effect, he says, by buying off doctors who were considered "opinion leaders" in the psychiatric field, along with state policy makers in positions of authority with control over the preferred drug lists.
For instance, Dr John Rush, from the University of Texas Southwestern Medical Center, served as the TMAP Project Co-Director with Dr Steven Shon, the Medical Director of the Texas Department of State Health Services.
Mr Jones determined that Dr Rush had received grants, research funding and served as a consultant and speaker for atypical makers Bristol-Myers, Janssen, Eli Lilly and Pfizer.
The director for the schizophrenia module was Dr Alexander Miller, of the University of Texas Health Science Center at San Antonio, who also served as a consultant, advisory board member and speaker for AstraZeneca, Bristol-Myers, Lilly, Janssen and Pfizer.
The director of the bipolar disorder module was Dr Patricia Suppes, from the University of Texas Southwestern Medical Center in Dallas, who also received grants and research funding and served as a consultant for AstraZeneca, Bristol-Myers, Janssen, Lilly and Pfizer.
Other University of Texas professors who participated in the development of TMAP included psychiatrist Dr Graham Emslie, who has received grants and research support and served as a consultant and member of speakers' bureaus for atypical makers Bristol-Myers, Lilly and Pfizer.
Another professor, Dr Karen Dineen Wagner, was a member of the speakers' bureaus for Janssen, Lilly and Pfizer, and a member of a scientific advisory board for Lilly, Janssen and Pfizer and received research funding from the same 3 atypical makers and Bristol-Myers.
Once the formulary was in place in Texas, the drug makers paid Dr Shon to travel around the country to convince policy makers in other states to use the TMAP model for their Medicaid approved list. Pennsylvania adopted the program and called it PennMap.
Mr Jones found that Janssen paid for Dr Shon to fly to Pennsylvania two times, and a document he obtained shows that the grant covering Dr Shon's travel expenses was "to expand atypical usage."
The New York Times reported that some payments were made through patient advocacy groups instead of directly to state officials. In 2002, Janssen gave the Olympia, WA, chapter of the National Alliance for the Mentally Ill a grant of $15,000 to fly Dr Shon and other Texas officials to speak to state legislators about the formulary, the Times found.
While reviewing the medical care provided to patients under state care in the summer of 2002, Dr Kruszewski immediately recognized that a mass drugging-for-profit scheme involving Medicaid patients, especially children, was taking place in Pennsylvania, and that several patients had died.
In one case, where the child fortunately survived, Dr Kruszewski found that the girl had been placed on 11 psychiatric drugs at the same time, including 5 antipsychotics, without ever being diagnosed with a psychiatric disorder. She exhibited impulsive behaviors and was mentally disabled, but there was nothing in the records to justify the use of all these drugs, he says.
According Dr Kruszewski, the atypicals are associated with an increased the risk of obesity which can lead to diabetes type II, hypertension, heart attacks and stroke. The weight of the girl who was on 11 drugs had ballooned from 106 pounds to 194, Dr Kruszewski found.
In reviewing patient records, he found a state-wide pattern where patients who were not mentally ill were placed on cocktails of 3 or more expensive psychiatric drugs at the same time and kept on the cocktails indefinitely and if patients experienced side effects from the original medications, more drugs were added to the mix.
The sheer greed evidenced by the mass drugging of patients on Medicaid all over the US, similar to that discovered by Dr Kruszewski in Pennsylvania, has forced state Medicaid programs to either put a stop to the drug maker's encouragement of the rampant prescribing of atypicals or go broke.
For instance, Texas Medicaid was charged nearly $15 million for antipsychotics for foster children in 2004, according to the December 2006 Special Report, "Foster Children - Texas Health Care Claims Study." In fact, Texas spent more money on antipsychotics for foster kids than any other class of drugs, and the report said, Zyprexa, Seroquel and Risperdal typically cost an average of $229 per prescription.
The report also pointed out that the drugs were not approved for children, and listed the health risks associated with the atypicals and stated, in part:
"These very powerful and expensive medications were prescribed despite a lack of studies demonstrating their safety and efficacy in children. There are questions regarding the long-term safety of these medications; documented serious side-effects include menstrual irregularities, gynecomastia, galactorrhea, possible pituitary tumors, hyperglycemia, type 2 diabetes and liver function abnormalities."
In a May 10, 2006 Press Release, Comptroller Carole Keeton Strayhorn said she was "particularly concerned" about the use and side effects of the atypical antipsychotic drugs.
"A clear pattern of overmedication and potential misdiagnosis of foster children is evident," she said and the "potential for Medicaid fraud and the possibility of long-term health problems in these children is alarming."
A USA TODAY study of FDA data from 2000 to 2004 found 45 pediatric deaths in which atypicals were the primary suspect, with at least six related to diabetes and other causes ranged from heart and pulmonary problems to Zyprexa, choking and liver failure.
A 15-year-old boy died of an overdose, an 8-year-old boy died of cardiac arrest, a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin, and the youngest death was a 4-year-old boy whose symptoms suggested diabetes complications, who was also taking 10 other drugs.
A July 29, 2007, report by Robert Farley in the St Petersburg Times revealed that in the last 7 years, the cost to Florida tax payers for atypicals prescribed to children jumped nearly 500%, from $4.7 million to $27.5 million, and on average in 2006, it cost the state nearly $1,800 for each child on atypicals.
Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration say children younger than 6 should generally not be given psychotropic drugs and they should "only be considered under the most extraordinary of circumstances."
According to Mr Jones, these new "miracle" drugs have proven to be no better than generics, and, "it is a statistical certainty that many lives have been lost and many others irreparably damaged."
In September 2005, the New England Journal of Medicine, reported that although Zyprexa was the most expensive and most prescribed antipsychotic, it was the only atypical that worked slightly better than the 40-year-old generic drug, perphenazine, but the NEJM also noted that Zyprexa had more side effects. The cost for a 3 month supply of Zyprexa in September, 2005 at drugstore.com, was $1,500, while a 3 month supply of perphenazine was only $135.
And the atypical drugging for profit scheme is not limited to the Medicaid population. An analysis revealed in March 2006 by investment firm CIBC World Markets showed that in the previous 12 months, the top 20 drugs in managed care spending included Zyprexa with $2.6 billion, Seroquel at $2.5 billion, and Risperdal was $2.2 billion.
The corrupt psychiatrists in Minnesota and other states might want to think about what is happening to "professionals" who were involved in similar behavior in Pennsylvania and Texas.
In Pennsylvania, the state Ethics Commission determined that Pfizer operated its own "Advisory Boards," comprised exclusively of formulary committee chairmen from various states who received honorariums and all-expense-paid trips from Pfizer at the same time they were evaluating Pfizer drugs for use in state mental health systems.
The Commission determined that Steven Fiorello, Director of the Pharmacy Services in the Office of Mental Health and Substance Abuse Services in Pennsylvania, and Chairman of the Formulary Committee, had used his office to obtain private pecuniary benefits for his participation in Pfizer's advisory board meetings in New York when he received honoraria for his participation in the meetings, as well as for his presentations at conferences in Orlando, Florida and Dublin, Ireland.
Mr Jones found that Mr Fiorello traveled to Pfizer's world headquarters in Manhattan 3 times to participate in advisory board meetings, with all expenses paid for by Pfizer, including lodging at Manhattan's Millennium Hotel and he was paid an honorarium of $1,000 for attending each meeting.
The Commission also found a number of additional violations, including Mr Fiorello's receipt of honoraria from other companies for whom he made presentations in connection with his public employment, and ordered Mr Fiorello to make restitution of $27,268.50 and referred the case to the Pennsylvania Attorney General's Public Corruption Unit.
On November 21, 2006, Mr Fiorello was charged with two counts of conflicts of interest, one count of accepting honoraria and one count of failing to disclose income on annual Statements of Financial Interests. In a press release, Pennsylvania's Attorney General stated: "As part of his responsibilities, Fiorello served on a committee that decided which drugs would be used for mental health treatment in all state hospitals - decisions which guided more than $9 million in annual drug purchases by the Commonwealth."
He also noted that, "while Fiorello was helping to guide the purchase of various drugs by the Department of Public Welfare, he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board."
Down in Texas, Dr Shon was fired last fall after the state's attorney general found that Janssen had improperly influenced him to list Risperdal on the state formulary. An October 9, 2006, letter to Dr Shon from Dr Charles Bell, acting commissioner of the Texas Department of State Health Services, obtained by the Austin American-Statesman states: "It is my determination that your services are no longer required by the Department."
"I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately," Dr Bell wrote.
In addition, Texas is now closely monitoring the prescribing of psychiatric drugs to Medicaid patients, and several psychiatrists have been ordered to reimburse the state for the cost of the drugs they prescribed to foster children.
Texas and Pennsylvania have also recently filed Medicaid fraud lawsuits against the makers of Zyprexa, Risperdal and Seroquel, seeking to recoup the cost of the drugs prescribed to Medicaid patients, as well as the medical care for persons injured by the drugs.
Influence peddling in the field of psychiatry is out of control. An analysis of Minnesota disclosure records by the Pioneer Press and the consumer watchdog group Public Citizen shows that, between 2002 and 2006, 187 Minnesota doctors received payments from drug companies worth a grand total of $7.38 million.
No other field of medicine even comes close to that amount. The next highest specialty was neurology, with 99 doctors receiving $2.89 million, according to the analysis.
In psychiatry, drug makers underwrite decision makers at every level of care, according to a May 10, 2007, report by Gardiner Harris in the New York Times. "They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow," Mr Harris states.
He determined that, between 2000 and 2005, payments to Minnesota psychiatrists increased more than six-fold. The Times also analyzed Minnesota Medicaid records, and the report provides details on how the financial relationships between doctors and drug makers have played a major role in the growing use of atypical antipsychotics with children.
The drugs include Zyprexa, marketed by Eli Lilly; Seroquel, by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.
The drugs are the most powerful psychiatric drugs on the market and were FDA-approved only to treat adults with schizophrenia or adults in the manic phase of bipolar disorder.
Over the past three years, every atypical maker has come under fire for influencing doctors to prescribe the drugs off-label to children for uses never approved by the FDA, and they are all currently involved in litigation related to the illegal promotion and sales of the drugs.
A study at Columbia University on the use of antipsychotics with children found that only a small percentage of the kids on the drugs had psychotic disorders and that, most of the time, the drugs were prescribed to treat mood disorders, depression, anxiety and ADHD.
Mr Harris reports that the Minnesota psychiatrists who received the most money from the drug's makers tended to prescribe them to kids the most often. On average, psychiatrists who received at least $5,000 between 2000 to 2005 appeared to have written 3 times as many prescriptions for kids as psychiatrists who received less or no money, the Times notes.
The rising Medicaid costs for atypicals also coincides with the rising payments to doctors. For instance, Minnesota Medicaid spent roughly $521,000 in 2000 on antipsychotics for children; but in 2005, the cost was more than $7 million, or a 14-fold increase.
In June 2007, Vermont officials revealed that disclosure records in that state showed payments to psychiatrists had more than doubled in one year, from an average of $20,835 in 2005, to an average $45,692 in 2005. There, too, antipsychotics were among the highest Medicaid drug expense.
The drug makers have shrinks in their pockets all over the country. However, only 3 states, Minnesota, Vermont and Maine, have laws that require companies to disclose their payments.
The media's recent reporting that members of a Minnesota advisory panel who decide which drugs will be covered by the state's Medicaid program are on the take, adds a new chapter to an old book. This same scam has been used in states all over the country since the late 1990's, and if not for two relentless fraud investigators from Pennsylvania, the fact that the formulary committees are bought and paid for by the pharmaceutical industry might have remained a secret for all time.
The fact that drug makers were bribing state policy makers and members of advisory panels with the ultimate goal of capturing the lucrative Medicaid customer base to increase the sale of psychiatric drugs was first discovered several years ago by Allen Jones, while he was a federal fraud investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations, and Dr Stefan Kruszewski, a pediatric psychiatrist by trade, who was hired by the Pennsylvania Department of Public Welfare to review the quality of care provided to persons covered by state programs.
According to Mr Jones, "the pharmaceutical industry has systematically infiltrated the mental health service delivery system of this nation."
"The situation uncovered in Minnesota," he says, "will be exposed in every state that demonstrates the political will to force transparency through full disclosure of industry payments to decision makers."
"Thinly veiled bribery of public officials by the pharmaceutical industry is a pervasive and deeply rooted problem," he warns.
During his investigation in Pennsylvania, Mr Jones found a drug money trail to key policy officials who controlled the Medicaid preferred drug list in that state, which eventually led him to Texas and an elaborate scheme that involved influential psychiatrists, including many who served as professors at Texas universities, and state policy officials who developed the preferred drug list known as the "Texas Medication Algorithm Project (TMAP)".
Mr Jones calls the Texas panel the "most transparent example" of industry influence, because all of the project directors had financial ties to the drug makers. It was put into effect, he says, by buying off doctors who were considered "opinion leaders" in the psychiatric field, along with state policy makers in positions of authority with control over the preferred drug lists.
For instance, Dr John Rush, from the University of Texas Southwestern Medical Center, served as the TMAP Project Co-Director with Dr Steven Shon, the Medical Director of the Texas Department of State Health Services.
Mr Jones determined that Dr Rush had received grants, research funding and served as a consultant and speaker for atypical makers Bristol-Myers, Janssen, Eli Lilly and Pfizer.
The director for the schizophrenia module was Dr Alexander Miller, of the University of Texas Health Science Center at San Antonio, who also served as a consultant, advisory board member and speaker for AstraZeneca, Bristol-Myers, Lilly, Janssen and Pfizer.
The director of the bipolar disorder module was Dr Patricia Suppes, from the University of Texas Southwestern Medical Center in Dallas, who also received grants and research funding and served as a consultant for AstraZeneca, Bristol-Myers, Janssen, Lilly and Pfizer.
Other University of Texas professors who participated in the development of TMAP included psychiatrist Dr Graham Emslie, who has received grants and research support and served as a consultant and member of speakers' bureaus for atypical makers Bristol-Myers, Lilly and Pfizer.
Another professor, Dr Karen Dineen Wagner, was a member of the speakers' bureaus for Janssen, Lilly and Pfizer, and a member of a scientific advisory board for Lilly, Janssen and Pfizer and received research funding from the same 3 atypical makers and Bristol-Myers.
Once the formulary was in place in Texas, the drug makers paid Dr Shon to travel around the country to convince policy makers in other states to use the TMAP model for their Medicaid approved list. Pennsylvania adopted the program and called it PennMap.
Mr Jones found that Janssen paid for Dr Shon to fly to Pennsylvania two times, and a document he obtained shows that the grant covering Dr Shon's travel expenses was "to expand atypical usage."
The New York Times reported that some payments were made through patient advocacy groups instead of directly to state officials. In 2002, Janssen gave the Olympia, WA, chapter of the National Alliance for the Mentally Ill a grant of $15,000 to fly Dr Shon and other Texas officials to speak to state legislators about the formulary, the Times found.
While reviewing the medical care provided to patients under state care in the summer of 2002, Dr Kruszewski immediately recognized that a mass drugging-for-profit scheme involving Medicaid patients, especially children, was taking place in Pennsylvania, and that several patients had died.
In one case, where the child fortunately survived, Dr Kruszewski found that the girl had been placed on 11 psychiatric drugs at the same time, including 5 antipsychotics, without ever being diagnosed with a psychiatric disorder. She exhibited impulsive behaviors and was mentally disabled, but there was nothing in the records to justify the use of all these drugs, he says.
According Dr Kruszewski, the atypicals are associated with an increased the risk of obesity which can lead to diabetes type II, hypertension, heart attacks and stroke. The weight of the girl who was on 11 drugs had ballooned from 106 pounds to 194, Dr Kruszewski found.
In reviewing patient records, he found a state-wide pattern where patients who were not mentally ill were placed on cocktails of 3 or more expensive psychiatric drugs at the same time and kept on the cocktails indefinitely and if patients experienced side effects from the original medications, more drugs were added to the mix.
The sheer greed evidenced by the mass drugging of patients on Medicaid all over the US, similar to that discovered by Dr Kruszewski in Pennsylvania, has forced state Medicaid programs to either put a stop to the drug maker's encouragement of the rampant prescribing of atypicals or go broke.
For instance, Texas Medicaid was charged nearly $15 million for antipsychotics for foster children in 2004, according to the December 2006 Special Report, "Foster Children - Texas Health Care Claims Study." In fact, Texas spent more money on antipsychotics for foster kids than any other class of drugs, and the report said, Zyprexa, Seroquel and Risperdal typically cost an average of $229 per prescription.
The report also pointed out that the drugs were not approved for children, and listed the health risks associated with the atypicals and stated, in part:
"These very powerful and expensive medications were prescribed despite a lack of studies demonstrating their safety and efficacy in children. There are questions regarding the long-term safety of these medications; documented serious side-effects include menstrual irregularities, gynecomastia, galactorrhea, possible pituitary tumors, hyperglycemia, type 2 diabetes and liver function abnormalities."
In a May 10, 2006 Press Release, Comptroller Carole Keeton Strayhorn said she was "particularly concerned" about the use and side effects of the atypical antipsychotic drugs.
"A clear pattern of overmedication and potential misdiagnosis of foster children is evident," she said and the "potential for Medicaid fraud and the possibility of long-term health problems in these children is alarming."
A USA TODAY study of FDA data from 2000 to 2004 found 45 pediatric deaths in which atypicals were the primary suspect, with at least six related to diabetes and other causes ranged from heart and pulmonary problems to Zyprexa, choking and liver failure.
A 15-year-old boy died of an overdose, an 8-year-old boy died of cardiac arrest, a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin, and the youngest death was a 4-year-old boy whose symptoms suggested diabetes complications, who was also taking 10 other drugs.
A July 29, 2007, report by Robert Farley in the St Petersburg Times revealed that in the last 7 years, the cost to Florida tax payers for atypicals prescribed to children jumped nearly 500%, from $4.7 million to $27.5 million, and on average in 2006, it cost the state nearly $1,800 for each child on atypicals.
Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration say children younger than 6 should generally not be given psychotropic drugs and they should "only be considered under the most extraordinary of circumstances."
According to Mr Jones, these new "miracle" drugs have proven to be no better than generics, and, "it is a statistical certainty that many lives have been lost and many others irreparably damaged."
In September 2005, the New England Journal of Medicine, reported that although Zyprexa was the most expensive and most prescribed antipsychotic, it was the only atypical that worked slightly better than the 40-year-old generic drug, perphenazine, but the NEJM also noted that Zyprexa had more side effects. The cost for a 3 month supply of Zyprexa in September, 2005 at drugstore.com, was $1,500, while a 3 month supply of perphenazine was only $135.
And the atypical drugging for profit scheme is not limited to the Medicaid population. An analysis revealed in March 2006 by investment firm CIBC World Markets showed that in the previous 12 months, the top 20 drugs in managed care spending included Zyprexa with $2.6 billion, Seroquel at $2.5 billion, and Risperdal was $2.2 billion.
The corrupt psychiatrists in Minnesota and other states might want to think about what is happening to "professionals" who were involved in similar behavior in Pennsylvania and Texas.
In Pennsylvania, the state Ethics Commission determined that Pfizer operated its own "Advisory Boards," comprised exclusively of formulary committee chairmen from various states who received honorariums and all-expense-paid trips from Pfizer at the same time they were evaluating Pfizer drugs for use in state mental health systems.
The Commission determined that Steven Fiorello, Director of the Pharmacy Services in the Office of Mental Health and Substance Abuse Services in Pennsylvania, and Chairman of the Formulary Committee, had used his office to obtain private pecuniary benefits for his participation in Pfizer's advisory board meetings in New York when he received honoraria for his participation in the meetings, as well as for his presentations at conferences in Orlando, Florida and Dublin, Ireland.
Mr Jones found that Mr Fiorello traveled to Pfizer's world headquarters in Manhattan 3 times to participate in advisory board meetings, with all expenses paid for by Pfizer, including lodging at Manhattan's Millennium Hotel and he was paid an honorarium of $1,000 for attending each meeting.
The Commission also found a number of additional violations, including Mr Fiorello's receipt of honoraria from other companies for whom he made presentations in connection with his public employment, and ordered Mr Fiorello to make restitution of $27,268.50 and referred the case to the Pennsylvania Attorney General's Public Corruption Unit.
On November 21, 2006, Mr Fiorello was charged with two counts of conflicts of interest, one count of accepting honoraria and one count of failing to disclose income on annual Statements of Financial Interests. In a press release, Pennsylvania's Attorney General stated: "As part of his responsibilities, Fiorello served on a committee that decided which drugs would be used for mental health treatment in all state hospitals - decisions which guided more than $9 million in annual drug purchases by the Commonwealth."
He also noted that, "while Fiorello was helping to guide the purchase of various drugs by the Department of Public Welfare, he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board."
Down in Texas, Dr Shon was fired last fall after the state's attorney general found that Janssen had improperly influenced him to list Risperdal on the state formulary. An October 9, 2006, letter to Dr Shon from Dr Charles Bell, acting commissioner of the Texas Department of State Health Services, obtained by the Austin American-Statesman states: "It is my determination that your services are no longer required by the Department."
"I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately," Dr Bell wrote.
In addition, Texas is now closely monitoring the prescribing of psychiatric drugs to Medicaid patients, and several psychiatrists have been ordered to reimburse the state for the cost of the drugs they prescribed to foster children.
Texas and Pennsylvania have also recently filed Medicaid fraud lawsuits against the makers of Zyprexa, Risperdal and Seroquel, seeking to recoup the cost of the drugs prescribed to Medicaid patients, as well as the medical care for persons injured by the drugs.
Lawmakers Want to End Big Pharma Recruitment Schemes - Part 2
Evelyn Pringle May 30, 2007
The whole idea of mining for psychiatric drug customers by screening all Americans for mental health disorders came to fruition as the result of the campaign contributions by the pharmaceutical industry, which in large part helped George W Bush take up residence in the White House.
To repay his enormous debt to the industry, on April 29, 2002, Bush paved the way for the implementation of the industry-funded screening programs and the mass drugging-for-profit scheme when he created the New Freedom Commission.
According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, It is merely one of the "Bush administration hand-outs to the drug companies, so many of which have changed from legitimate businesses into patent-protected rackets."
The recruitment of children as customers was a central goal of the industry, and Bush came through in helping meet that goal. The NFC's final report dated July 22, 2003, called for screening every American child for mental illness, including preschoolers, and said, "schools are in a key position to identify mental health problems early and to provide a link to appropriate services."
To that end, the report says, every child involved in a government program or is covered by Medicaid will automatically be screened under the following recommendation: "Screening should be implemented upon entry into, and periodically thereafter in, the juvenile justice and child welfare systems, as well as in other settings and populations with known high risk, such as the Medicaid population."
The report also specifically calls for screening programs to be linked to "state-of-the-art treatments" using "specific medications for specific conditions." A fact not mentioned is that 95% of the "specific medications" referred to were not FDA approved for treating children and have never been tested as safe and effective with children.
In addition, recent studies have shown that, although the rise in numbers of patients taking psychiatric drugs has skyrocketed over the past decade, there has been no decrease in mental illness. To the contrary, judging by the company sales figures, the man-made epidemic is still spreading like a wildfire.
But worst of all, for all the money spent and the stream of new serious side effect emerging each year, no patients are recovering from their alleged "mental disorders."
The screening program recommended by Bush's Commission for use in the public school system was TeenScreen, which created a controversy all across the country when the survey began being administered to students without the knowledge or consent of the parents.
TeenScreen claims it can identify several mental disorders. On March 2, 2004, while trying to drum up federal funding at a Congressional hearing, TeenScreen's Executive Director, Laurie Flynn, testified that, in the screening process, "youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality."
Critics disagree. "The TeenScreen program is a fraud," says Dr Lehrman. "It makes 'mental cases' rather than finding them by giving youngsters brain-injuring medicines."
The Citizens Commission for Human Rights points out that "human beings have been bumping and bumbling their way through adolescence for a few hundred thousand years, at least."
"Now TeenScreen and its allies," it says, "want to turn that right of passage into a profit center of psychiatrists and their allied pharmaceutical companies," in the November 2006 report, "TeenScreen: Life Saving Intervention, or Orwellian Nightmares?"
In addition, critics say any label of mental illness will have many life-long adverse effects on these children. They will have problems filling out job applications and applying for insurance when they have to say they were diagnosed mentally ill in childhood.
And this will especially be true for those children who have to reveal that the drugs they were prescribed as a child were atypical antipsychotics used to treat schizophrenia or bipolar disorder leading most people to logically conclude that the person has a life-long mental illness.
The atypicals include Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon, none of which are FDA approved for any use with children and are only approved for treating schizophrenia and manic episodes of bipolar disorder in adults.
Think about it. What do most people think of when they hear the term schizophrenia? Rightly or wrongly, they envision people who are delusional, hear voices, unpredictable and violent. In other words, the person is at least bizarre and at worst dangerous to be around.
And also, there is no denying that such a label results in stigmatism for life, because when do we ever hear that a person "used to have" schizophrenia or bipolar disorder? By design, the drug companies are setting up children to become life-long customers by having them labeled with the most serious of mental disorders.
For nearly 20 years, the drug makers have been raking in profits by promoting the selective serotonin reuptake inhibitor antidepressants (SSRIs) which include Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, as working better than the older drugs and concealing the association between the drugs and suicidality.
"Parents must be better informed," according to a report by The Citizens Commission on Human Rights.
"Few, if any, parents faced with the school situation of their child being labeled as 'mentally ill' or 'learning disordered' and coerced into taking psychiatric drugs, are told that there are many other factors that could be causing the child's inattention, behavior problems or learning difficulties," CCHR states.
"Common causes," the report says, "are poor reading and math skills requiring tutoring, environmental toxins, allergies, nutritional deficiencies, and other easily detectable and treatable physical conditions."
Special medical doctors can do tests to determine if a person is experiencing an allergic reaction, and diet can also help, the report notes.
Critics who have investigated the TeenScreen program say it is being sold to the public by the funneling of millions of industry dollars through front groups posing as patient advocacy groups. "The National Alliance for Mental Illness (NAMI)," Mr Kramer says, "pushes suicide screening of children nationwide and receives millions in drug money."
NAMI received $544,500 from Eli Lilly in the first quarter of this year alone, he notes.
The industry definitely gets a lot of bang for the buck when using NAMI and other front groups. Internationally known expert and author of many books on psychotropic drugs, psychiatrist, Dr Peter Breggin, founder of The International Center for the Study of Psychiatry and Psychology (ICSPP), says groups like NAMI hold national meetings that bring together drug advocates to talk directly to consumers.
"They also send out newsletters and other information that praise the drugs," he says.
"Sometimes," he adds, "they actively suppress viewpoints that are critical of drugs, for example, by discouraging the media from airing opposing viewpoints."
According to Mr Kramer, the TeenScreen advisory board also has major ties to the pharmaceutical industry.
Psychiatrist David Shaffer, who is credited with the development of the TeenScreen survey, is a paid consultant for GlaxoSmithKline on the matter of Paxil and adolescent suicide and has served as an expert witness in lawsuits against plaintiffs injured by pharmaceutical products on behalf of Hoffman la Roche and Wyeth Pharmaceuticals.
In January 2004, Shaffer co-authored a report in the Journal of the American College of Neuropsychopharmacology that claimed, "SSRI antidepressants do not increase the risk of suicidal thinking or suicide attempts in youth."
By design, the report coincided with the scheduled FDA advisory committee hearings on the issue of whether SSRI use was associated with suicidality in children, and all authors but one had extensive ties to the industry. In the end, the panel ignored Shaffer's bogus study and determined that a black box warning should be added to SSRI labels.
A few months later, on December 9, 2004, ABC's Prime Time Live revealed that at least 100 children in the US had committed suicide while taking these new antidepressants and many more had attempted suicide.
The fact that SSRIs cause violence in some people was also concealed by the drug makers for years. As far back as November 2002, Fox News reported that 7 of the 12 teens involved in school shootings were either taking SSRIs or stimulants or were experiencing the withdrawal effects from the drugs and that the possible drug use by the other 5 shooters was unknown at the time because their medical records were sealed. Columbine shooter Eric Harris was on Luvox.
Critics say it's no coincidence that TeenScreen leader Laurie Flynn was the CEO of NAMI for 16 years before she was promoted to head TeenScreen.
Under Flynn, CCHR reports, NAMI became a virtual marketing arm of the industry, stating in its Guidelines for the Relationship between NAMI and the Campaign's Founding Sponsors: "Providers, health plans, and pharmaceutical companies want to grow their markets and to increase their share of the market...NAMI will cooperate with these entities to grow the market by making persons aware of the issues involving severe brain disorders...and by helping persons to adhere to their treatment plans."
An Indiana mother, Teresa Rhodes, has created an online petition against TeenScreen after her 15-year-old daughter, Chelsea, was screened at school without parental consent and was falsely labeled with not one but 2 mental illnesses, obsessive-compulsive disorder and social anxiety disorder. People wishing to sign the petition can do so by clicking on this link http://www.petitiononline.com/TScreen/petition.html.
Mr Kramer says the petition is an excellent way to educate people about TeenScreen because it conveys many of the facts about mental health screening and can be printed off and presented to school board members and local, state and federal legislators.
Activist Vince Boehm has been advocating against screening and the drugging of children for more years than he would like to count. However, he got especially upset recently while watching a discussion on TV about the positive business outlook for the sale of psychiatric drugs to children.
"I was listening to the Bloomberg Business Channel recently," he says, "and caught an interview with a drug company sales executive."
"He was talking about how his market share for psychiatric drugs was booming in the pediatric market," he recalled.
"Then I thought about the children," Vince said and screamed at the TV, "You jackass! (I actually used a somewhat stronger expletive), these are not 'market shares' they are kids!"
According to Laurie Yorke, "Pandora's Box is an understatement when it comes to mental health screening."
Laurie is a Registered Nurse whose son was labeled mentally ill and prescribed Paxil and experienced a severe withdrawal syndrome when he stopped taking the drug.
"I think one thing that is never mentioned with TeenScreen," she states, "is how is the school going to handle a child who has been labeled?"
"What if a child is diagnosed with an 'anxiety disorder,' she points out. "Is the school prepared to provide home instruction, smaller classrooms, or whatever is required to educate that child?"
"I bring this up," she notes, "because Ryan's school denied his withdrawal from Paxil, accused me of 'working the system' and attacked my reputation to all who would listen and finally withdrew his home instruction."
As a result, Laurie says, her son withdrew from high school altogether. "If this is how they treat someone who is 'labeled,'" she asks, "how are they going to provide an education for all of those who are being labeled because of TeenScreen?"
In addition, she points out, "how are they going to handle all the children suffering from adverse effects from a drug that they have been prescribed as a result of TeenScreen?"
On May 17, 2007, Laurie testified at a hearing in support of a New Jersey legislative bill that requires physicians and other prescribers to obtain informed consent from parents or guardians of minors who are prescribed psychotropic medication with "black box warnings," to include informing the parent or guardian of all the potential adverse events associated with the drug.
The bill specifies that a physician or other authorized prescriber who prescribes a medication in violation of this act shall be subject to disciplinary action by the State Board of Medical Examiners. The bill was approved by the State Assembly's Consumer Affairs Committee.
Before allowing children to take SSRIs, Mr Kramer recommends that at the very least, everyone should get educated on the black box warning which states: "Antidepressants increase the risk of suicidal thinking and behavior in children and adolescents."
"This FDA warning alone," he notes, "should be a wake-up call for any true suicide prevention effort."
The Alliance for Human Research Protection is taking activism a step further by kicking off a campaign urging restrictions on off-label use of all drugs that carry black box warnings.
"Inasmuch as these drugs are deemed by the FDA to carry life-threatening risks of harm," says AHRP director Vera Hassner Sharav, "their use should be restricted and off-label prescribing of these drugs should be off-limits!"
Bush's plan for screening the nation's roughly 36 million senior citizens is set up through the "Positive Aging Act of 2005." The Act provides federal tax dollars for community-based outreach teams to hunt down the elderly wherever they can be found whether it be at senior citizen centers, adult day care programs, or assisted living facilities.
The whole idea of mining for psychiatric drug customers by screening all Americans for mental health disorders came to fruition as the result of the campaign contributions by the pharmaceutical industry, which in large part helped George W Bush take up residence in the White House.
To repay his enormous debt to the industry, on April 29, 2002, Bush paved the way for the implementation of the industry-funded screening programs and the mass drugging-for-profit scheme when he created the New Freedom Commission.
According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, It is merely one of the "Bush administration hand-outs to the drug companies, so many of which have changed from legitimate businesses into patent-protected rackets."
The recruitment of children as customers was a central goal of the industry, and Bush came through in helping meet that goal. The NFC's final report dated July 22, 2003, called for screening every American child for mental illness, including preschoolers, and said, "schools are in a key position to identify mental health problems early and to provide a link to appropriate services."
To that end, the report says, every child involved in a government program or is covered by Medicaid will automatically be screened under the following recommendation: "Screening should be implemented upon entry into, and periodically thereafter in, the juvenile justice and child welfare systems, as well as in other settings and populations with known high risk, such as the Medicaid population."
The report also specifically calls for screening programs to be linked to "state-of-the-art treatments" using "specific medications for specific conditions." A fact not mentioned is that 95% of the "specific medications" referred to were not FDA approved for treating children and have never been tested as safe and effective with children.
In addition, recent studies have shown that, although the rise in numbers of patients taking psychiatric drugs has skyrocketed over the past decade, there has been no decrease in mental illness. To the contrary, judging by the company sales figures, the man-made epidemic is still spreading like a wildfire.
But worst of all, for all the money spent and the stream of new serious side effect emerging each year, no patients are recovering from their alleged "mental disorders."
The screening program recommended by Bush's Commission for use in the public school system was TeenScreen, which created a controversy all across the country when the survey began being administered to students without the knowledge or consent of the parents.
TeenScreen claims it can identify several mental disorders. On March 2, 2004, while trying to drum up federal funding at a Congressional hearing, TeenScreen's Executive Director, Laurie Flynn, testified that, in the screening process, "youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality."
Critics disagree. "The TeenScreen program is a fraud," says Dr Lehrman. "It makes 'mental cases' rather than finding them by giving youngsters brain-injuring medicines."
The Citizens Commission for Human Rights points out that "human beings have been bumping and bumbling their way through adolescence for a few hundred thousand years, at least."
"Now TeenScreen and its allies," it says, "want to turn that right of passage into a profit center of psychiatrists and their allied pharmaceutical companies," in the November 2006 report, "TeenScreen: Life Saving Intervention, or Orwellian Nightmares?"
In addition, critics say any label of mental illness will have many life-long adverse effects on these children. They will have problems filling out job applications and applying for insurance when they have to say they were diagnosed mentally ill in childhood.
And this will especially be true for those children who have to reveal that the drugs they were prescribed as a child were atypical antipsychotics used to treat schizophrenia or bipolar disorder leading most people to logically conclude that the person has a life-long mental illness.
The atypicals include Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon, none of which are FDA approved for any use with children and are only approved for treating schizophrenia and manic episodes of bipolar disorder in adults.
Think about it. What do most people think of when they hear the term schizophrenia? Rightly or wrongly, they envision people who are delusional, hear voices, unpredictable and violent. In other words, the person is at least bizarre and at worst dangerous to be around.
And also, there is no denying that such a label results in stigmatism for life, because when do we ever hear that a person "used to have" schizophrenia or bipolar disorder? By design, the drug companies are setting up children to become life-long customers by having them labeled with the most serious of mental disorders.
For nearly 20 years, the drug makers have been raking in profits by promoting the selective serotonin reuptake inhibitor antidepressants (SSRIs) which include Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, as working better than the older drugs and concealing the association between the drugs and suicidality.
"Parents must be better informed," according to a report by The Citizens Commission on Human Rights.
"Few, if any, parents faced with the school situation of their child being labeled as 'mentally ill' or 'learning disordered' and coerced into taking psychiatric drugs, are told that there are many other factors that could be causing the child's inattention, behavior problems or learning difficulties," CCHR states.
"Common causes," the report says, "are poor reading and math skills requiring tutoring, environmental toxins, allergies, nutritional deficiencies, and other easily detectable and treatable physical conditions."
Special medical doctors can do tests to determine if a person is experiencing an allergic reaction, and diet can also help, the report notes.
Critics who have investigated the TeenScreen program say it is being sold to the public by the funneling of millions of industry dollars through front groups posing as patient advocacy groups. "The National Alliance for Mental Illness (NAMI)," Mr Kramer says, "pushes suicide screening of children nationwide and receives millions in drug money."
NAMI received $544,500 from Eli Lilly in the first quarter of this year alone, he notes.
The industry definitely gets a lot of bang for the buck when using NAMI and other front groups. Internationally known expert and author of many books on psychotropic drugs, psychiatrist, Dr Peter Breggin, founder of The International Center for the Study of Psychiatry and Psychology (ICSPP), says groups like NAMI hold national meetings that bring together drug advocates to talk directly to consumers.
"They also send out newsletters and other information that praise the drugs," he says.
"Sometimes," he adds, "they actively suppress viewpoints that are critical of drugs, for example, by discouraging the media from airing opposing viewpoints."
According to Mr Kramer, the TeenScreen advisory board also has major ties to the pharmaceutical industry.
Psychiatrist David Shaffer, who is credited with the development of the TeenScreen survey, is a paid consultant for GlaxoSmithKline on the matter of Paxil and adolescent suicide and has served as an expert witness in lawsuits against plaintiffs injured by pharmaceutical products on behalf of Hoffman la Roche and Wyeth Pharmaceuticals.
In January 2004, Shaffer co-authored a report in the Journal of the American College of Neuropsychopharmacology that claimed, "SSRI antidepressants do not increase the risk of suicidal thinking or suicide attempts in youth."
By design, the report coincided with the scheduled FDA advisory committee hearings on the issue of whether SSRI use was associated with suicidality in children, and all authors but one had extensive ties to the industry. In the end, the panel ignored Shaffer's bogus study and determined that a black box warning should be added to SSRI labels.
A few months later, on December 9, 2004, ABC's Prime Time Live revealed that at least 100 children in the US had committed suicide while taking these new antidepressants and many more had attempted suicide.
The fact that SSRIs cause violence in some people was also concealed by the drug makers for years. As far back as November 2002, Fox News reported that 7 of the 12 teens involved in school shootings were either taking SSRIs or stimulants or were experiencing the withdrawal effects from the drugs and that the possible drug use by the other 5 shooters was unknown at the time because their medical records were sealed. Columbine shooter Eric Harris was on Luvox.
Critics say it's no coincidence that TeenScreen leader Laurie Flynn was the CEO of NAMI for 16 years before she was promoted to head TeenScreen.
Under Flynn, CCHR reports, NAMI became a virtual marketing arm of the industry, stating in its Guidelines for the Relationship between NAMI and the Campaign's Founding Sponsors: "Providers, health plans, and pharmaceutical companies want to grow their markets and to increase their share of the market...NAMI will cooperate with these entities to grow the market by making persons aware of the issues involving severe brain disorders...and by helping persons to adhere to their treatment plans."
An Indiana mother, Teresa Rhodes, has created an online petition against TeenScreen after her 15-year-old daughter, Chelsea, was screened at school without parental consent and was falsely labeled with not one but 2 mental illnesses, obsessive-compulsive disorder and social anxiety disorder. People wishing to sign the petition can do so by clicking on this link http://www.petitiononline.com/TScreen/petition.html.
Mr Kramer says the petition is an excellent way to educate people about TeenScreen because it conveys many of the facts about mental health screening and can be printed off and presented to school board members and local, state and federal legislators.
Activist Vince Boehm has been advocating against screening and the drugging of children for more years than he would like to count. However, he got especially upset recently while watching a discussion on TV about the positive business outlook for the sale of psychiatric drugs to children.
"I was listening to the Bloomberg Business Channel recently," he says, "and caught an interview with a drug company sales executive."
"He was talking about how his market share for psychiatric drugs was booming in the pediatric market," he recalled.
"Then I thought about the children," Vince said and screamed at the TV, "You jackass! (I actually used a somewhat stronger expletive), these are not 'market shares' they are kids!"
According to Laurie Yorke, "Pandora's Box is an understatement when it comes to mental health screening."
Laurie is a Registered Nurse whose son was labeled mentally ill and prescribed Paxil and experienced a severe withdrawal syndrome when he stopped taking the drug.
"I think one thing that is never mentioned with TeenScreen," she states, "is how is the school going to handle a child who has been labeled?"
"What if a child is diagnosed with an 'anxiety disorder,' she points out. "Is the school prepared to provide home instruction, smaller classrooms, or whatever is required to educate that child?"
"I bring this up," she notes, "because Ryan's school denied his withdrawal from Paxil, accused me of 'working the system' and attacked my reputation to all who would listen and finally withdrew his home instruction."
As a result, Laurie says, her son withdrew from high school altogether. "If this is how they treat someone who is 'labeled,'" she asks, "how are they going to provide an education for all of those who are being labeled because of TeenScreen?"
In addition, she points out, "how are they going to handle all the children suffering from adverse effects from a drug that they have been prescribed as a result of TeenScreen?"
On May 17, 2007, Laurie testified at a hearing in support of a New Jersey legislative bill that requires physicians and other prescribers to obtain informed consent from parents or guardians of minors who are prescribed psychotropic medication with "black box warnings," to include informing the parent or guardian of all the potential adverse events associated with the drug.
The bill specifies that a physician or other authorized prescriber who prescribes a medication in violation of this act shall be subject to disciplinary action by the State Board of Medical Examiners. The bill was approved by the State Assembly's Consumer Affairs Committee.
Before allowing children to take SSRIs, Mr Kramer recommends that at the very least, everyone should get educated on the black box warning which states: "Antidepressants increase the risk of suicidal thinking and behavior in children and adolescents."
"This FDA warning alone," he notes, "should be a wake-up call for any true suicide prevention effort."
The Alliance for Human Research Protection is taking activism a step further by kicking off a campaign urging restrictions on off-label use of all drugs that carry black box warnings.
"Inasmuch as these drugs are deemed by the FDA to carry life-threatening risks of harm," says AHRP director Vera Hassner Sharav, "their use should be restricted and off-label prescribing of these drugs should be off-limits!"
Bush's plan for screening the nation's roughly 36 million senior citizens is set up through the "Positive Aging Act of 2005." The Act provides federal tax dollars for community-based outreach teams to hunt down the elderly wherever they can be found whether it be at senior citizen centers, adult day care programs, or assisted living facilities.
Thursday, August 5, 2010
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.
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.
Tuesday, August 3, 2010
Whistleblowers Reveal Over-Medicating For Profit
Evelyn Pringle February 19, 2006
In Pennsylvania, whistleblower, Dr Kruszewski, discovered cases where adults and children in state care were prescribed as many as 5 psychiatric drugs at the same time. When he went to his superiors to report the over-prescribing and warned of the potential liability to the state if it was allowed to continue, he was told "it is none of your business."
According to Dr Kruszewski, it was polypharmacy at its worst. "They were putting almost all the patients on the same concoction of antipsychotic and antiseizure drugs," he reports.
But the discovery he found most disturbing was that many of the patients taking the drugs had never had seizures and had never been psychotic.
The fact is that drug companies are making a fortune off drugging patients who are covered by tax payer funded government programs. The drug pushing begins with preferred drug lists maintained in most states. Once a drug is added to the list, it is prescribed as a first line of treatment for all people in state run institutions and all patients in the general population who are covered by programs like Medicaid and Medicare.
The lists represent a goldmine to drug companies. For instance, if Eli Lilly's one antipsychotic drug Zyprexa, was to be removed from the preferred drug list in Florida, the company would lose $70 million annually, according to the November 2005 Indianapolis Business Journal.
In 2004, Lilly billed Florida Medicaid over $20 per pill for Zyprexa according to a Presentation to Senate Health and Human Services Appropriations Committee on January 13, 2005.
Pharmaceutical companies will go to any lengths to get their drugs added to the lists, including the use of financial incentives to influence state officials and policy makers involved in compiling and maintaining the lists.
Whistleblower, Allen Jones, was an Investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, when he discovered drug company money was being used to influence state officials and policy makers when the preferred drug list was being implemented in that state.
To put the amount of money involved in perspective, the drug Zyprexa is prescribed for schizophrenia, and according to Mr Jones' estimates, Pennsylvania has approximately 9,000 schizophrenics in state run prisons and mental hospitals on any given date.
"And based on the average length of stay, an additional 4,000 patients move through the system each year resulting in the potential recruitment of 13,000 customers, worth about $6,000 each per year," he reports.
"Once these folks left institutions with prescriptions in hand," Mr Jones adds, "many are supported through Medicaid."
During his investigation, when examining the payment of money to state employees, Mr Jones said, "I began to look at the overall issue of Pharma marketing and immediately became alarmed that tactics used in marketing to the private sector were being replicated with state employees."
He was suspicions about the drugs on the list because: (1) the recommended drugs were exclusively new, patented and expensive; (2) they were selected by expert consensus of persons with financial ties to Pharma; and (3) claims of increased efficacy and safety by drug companies and state employees were contradicted by scientific studies.
"These new "miracle" drugs did not live up to their hype," Mr Jones said, "they have proven to no better than generics."
"Most importantly," he explained, "most of the new drugs have been found to cause serious, even fatal side-effects, particularly in children."
"It is a statistical certainty," he added, "that many lives have been lost and many others irreparably damaged."
During his investigation Mr Jones discovered an off the record account used to funnel drug company money to state officials and policy makers who were being treated to lavish meals and expensive travel and were receiving consultant fees and honorariums.
"Some state employees were paid up to $2,000 for speaking in their official capacities at drug-company sponsored events," Mr Jones said. "It is illegal for a public employee to accept honorariums and to consult with industry without permission, yet it was happening openly," he explained.
When he went to his superiors with his report, Mr Jones says, "I was limited, shut down, ordered to limit my investigation and ultimately threatened when I refused to set aside what I was finding."
"They maintained a deliberate ignorance of what was going on, they did not want to know," he said, "the word came down to kill my investigation and rein me in."
He refused to be reined in and continued his investigation on his own time. When he finally went public with his findings to the New York Times, Mr Jones was fired. He has since filed a whistleblower lawsuit.
Psychiatrist, Dr Stefan Kruszewski, was hired by the Pennsylvania Bureau of Program Integrity in the Department of Public Welfare to oversee the mental health and substance abuse programs.
During his investigation, Dr Kruszewski uncovered serious abuses, including the deaths of four children and one adult while in state custody, due to substandard care and the off-label prescribing of atypical antipsychotics.
The people most vulnerable to medicating for profit were the disabled, dependent children in state care, the prison population, and children hooked into the state juvenile justice system.
In June 2003 Dr Kruszewski, traveled to an out-of-state inpatient facility that housed 24 children from Pennsylvania whose placement in the center had been facilitated by the Pennsylvania Office of Medical Assistance and whose oversight was, in part, the responsibility of the Bureau of Program Integrity.
"The reasons for that trip," he said, "was another unexpected death of a child."
On July 9, 2003, Dr Kruszewski's written preliminary assessment on the investigation revealed children who were severely overmedicated with antipsychotics, antidepressants and anticonvulsants were housed in deplorable living arrangements and receiving 'treatment' that often violated their emotional, mental and physical well-being. The investigation also revealed that children were being sexually abused by staff personnel.
Dr Kruszewski recommended the removal of the children from the facility and also advised his superiors to consider removing children and adults from several other facilities "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," he advised.
Dr Kruszewski was fired in July 2003 when he refused to be silenced after his discoveries.
In his whistleblower lawsuit against Pennsylvania officials and several drug companies, Dr Kruszewski describes corrupt practices, that include fraudulent billings, overmedicating of adults and children, and the misuse of medication that resulted in death to persons under the care of the state.
The lawsuit, also says drug companies have "distorted statistics, violated regulations and misrepresented the effects of the use of their psychotropic drugs simply to make money."
According to Dr Kruszewski, in order to sell more drugs, pharmaceutical companies have misrepresented their effectiveness, "by knowingly reporting incomplete and inaccurate research results of their safety profiles, and by off-label promotion."
In Pennsylvania, whistleblower, Dr Kruszewski, discovered cases where adults and children in state care were prescribed as many as 5 psychiatric drugs at the same time. When he went to his superiors to report the over-prescribing and warned of the potential liability to the state if it was allowed to continue, he was told "it is none of your business."
According to Dr Kruszewski, it was polypharmacy at its worst. "They were putting almost all the patients on the same concoction of antipsychotic and antiseizure drugs," he reports.
But the discovery he found most disturbing was that many of the patients taking the drugs had never had seizures and had never been psychotic.
The fact is that drug companies are making a fortune off drugging patients who are covered by tax payer funded government programs. The drug pushing begins with preferred drug lists maintained in most states. Once a drug is added to the list, it is prescribed as a first line of treatment for all people in state run institutions and all patients in the general population who are covered by programs like Medicaid and Medicare.
The lists represent a goldmine to drug companies. For instance, if Eli Lilly's one antipsychotic drug Zyprexa, was to be removed from the preferred drug list in Florida, the company would lose $70 million annually, according to the November 2005 Indianapolis Business Journal.
In 2004, Lilly billed Florida Medicaid over $20 per pill for Zyprexa according to a Presentation to Senate Health and Human Services Appropriations Committee on January 13, 2005.
Pharmaceutical companies will go to any lengths to get their drugs added to the lists, including the use of financial incentives to influence state officials and policy makers involved in compiling and maintaining the lists.
Whistleblower, Allen Jones, was an Investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, when he discovered drug company money was being used to influence state officials and policy makers when the preferred drug list was being implemented in that state.
To put the amount of money involved in perspective, the drug Zyprexa is prescribed for schizophrenia, and according to Mr Jones' estimates, Pennsylvania has approximately 9,000 schizophrenics in state run prisons and mental hospitals on any given date.
"And based on the average length of stay, an additional 4,000 patients move through the system each year resulting in the potential recruitment of 13,000 customers, worth about $6,000 each per year," he reports.
"Once these folks left institutions with prescriptions in hand," Mr Jones adds, "many are supported through Medicaid."
During his investigation, when examining the payment of money to state employees, Mr Jones said, "I began to look at the overall issue of Pharma marketing and immediately became alarmed that tactics used in marketing to the private sector were being replicated with state employees."
He was suspicions about the drugs on the list because: (1) the recommended drugs were exclusively new, patented and expensive; (2) they were selected by expert consensus of persons with financial ties to Pharma; and (3) claims of increased efficacy and safety by drug companies and state employees were contradicted by scientific studies.
"These new "miracle" drugs did not live up to their hype," Mr Jones said, "they have proven to no better than generics."
"Most importantly," he explained, "most of the new drugs have been found to cause serious, even fatal side-effects, particularly in children."
"It is a statistical certainty," he added, "that many lives have been lost and many others irreparably damaged."
During his investigation Mr Jones discovered an off the record account used to funnel drug company money to state officials and policy makers who were being treated to lavish meals and expensive travel and were receiving consultant fees and honorariums.
"Some state employees were paid up to $2,000 for speaking in their official capacities at drug-company sponsored events," Mr Jones said. "It is illegal for a public employee to accept honorariums and to consult with industry without permission, yet it was happening openly," he explained.
When he went to his superiors with his report, Mr Jones says, "I was limited, shut down, ordered to limit my investigation and ultimately threatened when I refused to set aside what I was finding."
"They maintained a deliberate ignorance of what was going on, they did not want to know," he said, "the word came down to kill my investigation and rein me in."
He refused to be reined in and continued his investigation on his own time. When he finally went public with his findings to the New York Times, Mr Jones was fired. He has since filed a whistleblower lawsuit.
Psychiatrist, Dr Stefan Kruszewski, was hired by the Pennsylvania Bureau of Program Integrity in the Department of Public Welfare to oversee the mental health and substance abuse programs.
During his investigation, Dr Kruszewski uncovered serious abuses, including the deaths of four children and one adult while in state custody, due to substandard care and the off-label prescribing of atypical antipsychotics.
The people most vulnerable to medicating for profit were the disabled, dependent children in state care, the prison population, and children hooked into the state juvenile justice system.
In June 2003 Dr Kruszewski, traveled to an out-of-state inpatient facility that housed 24 children from Pennsylvania whose placement in the center had been facilitated by the Pennsylvania Office of Medical Assistance and whose oversight was, in part, the responsibility of the Bureau of Program Integrity.
"The reasons for that trip," he said, "was another unexpected death of a child."
On July 9, 2003, Dr Kruszewski's written preliminary assessment on the investigation revealed children who were severely overmedicated with antipsychotics, antidepressants and anticonvulsants were housed in deplorable living arrangements and receiving 'treatment' that often violated their emotional, mental and physical well-being. The investigation also revealed that children were being sexually abused by staff personnel.
Dr Kruszewski recommended the removal of the children from the facility and also advised his superiors to consider removing children and adults from several other facilities "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," he advised.
Dr Kruszewski was fired in July 2003 when he refused to be silenced after his discoveries.
In his whistleblower lawsuit against Pennsylvania officials and several drug companies, Dr Kruszewski describes corrupt practices, that include fraudulent billings, overmedicating of adults and children, and the misuse of medication that resulted in death to persons under the care of the state.
The lawsuit, also says drug companies have "distorted statistics, violated regulations and misrepresented the effects of the use of their psychotropic drugs simply to make money."
According to Dr Kruszewski, in order to sell more drugs, pharmaceutical companies have misrepresented their effectiveness, "by knowingly reporting incomplete and inaccurate research results of their safety profiles, and by off-label promotion."
Monday, August 2, 2010
Bush Administration - Money, Politics & Drugs
Evelyn Pringle February 2005
A new plan by the Bush administration to test the nation's public school population for mental disorders and treat them with controversial drugs has raised an alarm among some medical science watchdogs and members of the mental health community, according to the June 27, 2004, New Standard.
Bush wants to launch a mental health and disability initiative that recommends the screening and treatment for students K-12 in public schools. The plan is based on a Texas program known as the "Texas Mental Health Parity."
The Texas model has been implemented in other states, including Pennsylvania, where a government whistleblower, Allan Jones, has called it "a Trojan horse" for pharmaceutical companies. If enacted on a national level, the scheme would mandate widespread testing all across the country which would result in the recruitment of hundreds of thousands of new customers for the pharmaceutical Industry.
Jones was a state employee in Pennsylvania at the time the program was put into place there. He later became a Whistleblower and says, "the pharmaceutical industry has methodically compromised our political system at all levels and has systematically infiltrated the mental health service delivery system of this nation."
"They are poised to consolidate their grip, via the New Freedom Commission and the Texas Medication Algorithm Project," Jones says. "The pervasive manipulation of clinical trials, the non-reporting of negative trials and the cover-up of debilitating and deadly side effects render meaningful informed consent impossible by persons being treated with these drugs," he warns.
Jones believes that doctors and patients alike have been betrayed by the governmental entities and officials who are supposed to protect them, and I agree 100%.
I was outraged, as I was forced to watch Bush and the drug companies set up a scam to used senior citizens as funnels with the Medicare Prescription Drug Bill. But you can bet that I will not sit back and watch them implement their latest profiteering scheme when it involves drugging my grandkids.
They won't be satisfied until they have every kid in the country drugged. Despite the nearly 500% increase in the number of children being prescribed psychiatric drugs, the administration's, New Freedom Commission on Mental Health (NFC), claims that there are not enough children benefiting from mental health treatment and recommends mandatory screening for all high school students, with follow-up treatment as required.
If Bush has his way, the Texas Medication Algorithm Project (TMAP) will serve as a model for the upcoming nationwide program, according to the NFC.
The TMAP began in 1995, when a group of individuals from the pharmaceutical industry, joined up with officials from the Texas state university, and state mental health and corrections systems. The program’s initial funding included a $1.7 million grant from the Robert Wood Johnson Foundation; and off-shoot of the Johnson & Johnson Pharmaceutical company. Johnson & Johnson owns the drug companies Janssen Pharmaceutica and Janssen/Ortho McNeil, according to “Law Project For Psychiatric Rights,” by Jones.
Its more than obvious that the true goal of this group was to develop a program of drug treatment for use in the juvenile justice system, state foster care program, mental health hospitals, and prison systems, which would generate high volume sales of new expensive drugs. As Texas Governor, Bush supported legislation that required private industry to provide increased insurance coverage for mental health treatment and drugs.
The medication guidelines for the TMAP were established by an "expert consensus" based on the opinions of prescribers, rather than clinical studies. Nearly all of the major drug companies helped fund the scheme, including Eli Lilly, Janssen Pharmaceutica, Johnson & Johnson, Astrazeneca, Novartis, Janssen-Ortho-McNeil, GlaxoSmithKline, Abbott, Pfizer, Bristol Myers Squibb, Wyeth-Ayerst and Forrest Laboratories.
The drugs recommended by the "experts" for "first line treatment,” were the new drugs manufactured by the same companies that funded the scheme and included, Zyprexa, Paxil, Zoloft, Allerall, Risperdal, Seroqual, Depakote, Pozac, Celexa, Wellbutron, Zyban, Remeron, Serzone, Effexor, and Buspar.
The TMAP gave the pharmaceutical industry unlimited access to the Texas prison system, juvenile justice system, foster care program, and state mental health hospitals, by which to expand its customer base and increase the sale of over-priced drugs.
Next, Texas lawmakers passed legislation that would increase Medicaid coverage to persons who would not ordinarily qualify, and increased the state budget to provide funding to pay for drugs prescribed to people within the public systems.
As the Texas program spread to other states, the scam did not go unnoticed. A May, 2004 report by the New York Times, explained how drug companies were using new strategies to capture the Medicaid and Medicare markets that involved a "focus on a much smaller group of customers: state officials who oversee treatment for many people with serious mental illness. Those patients -- in mental hospitals, at mental health clinics and on Medicaid -- make states among the largest buyers of anti-psychotic drugs," the report noted.
By some accounts, between 1999 to 2003, antidepressant prescriptions for children in the US have increased over 500%, often with devastating results. For example, Paxil was one of the new miracle drugs recommended by the TCMAP “expert consensus” panel and prescribed to children even though it was basically untested.
Since then, the drug has been linked to a rising number of dangerous side effects in children, and lawsuits have listed it as a contributing factor in suicide, murder, debilitating injury and school shootings.
In June of 2003, the FDA finally issued a warning that Paxil should not be prescribed for children due to the alarming rise in suicides by children who were taking the drug.
Money, Politics & Drugs
According to the Center for Responsive Politics, in his 2 bids for the presidency, Bush has been the number one recipient of campaign donations from the pharmaceutical industry, in either party. The same Robert Wood Johnson IV, who has ties to the foundation mentioned above, and is also heir to the Johnson & Johnson fortune, raised over $100,000 for Bush’s 2000 campaign, and over $200,000 for campaign 2004.
The next top recipients, were Congressman Mike Ferguson (R-NJ) and Senator John Burr (R-NC), each of whom sits on Energy and Commerce Subcommittees on Health, which oversee mental health and research, biomedical programs, food and drug policies, and Medicaid.
An obvious example of mixing drugs, money & politics, can be found with the drug, Zyprexa. It was one of the drugs recommended in the TMAP. With more than $4 billion in sales worldwide, in 2003, it was Eli Lilly’s top selling drug. In the US, for the most part, tax payers footed the bill for this drug. According to the New York Times, 70% of Zyprexa sales in this country in 2003, were paid for by programs like Medicare and Medicaid.
Its no secret that Eli Lilly has long-standing ties to the Bush administration. At one time, Bush Sr was a member of Lilly's board of directors, and the current President Bush made Lilly CEO, Sidney Taurel, a member of the Homeland Security Council.
In the 2000 election Lilly contributed over $1.5 million to political candidates, with over 80% going to Bush and the Republican Party.
In fact, looking at the total drug company donations during campaign 2004, Bush won by a land slide. According to the Center for Responsive Politics, by April, 2004, manufacturers of drugs and health products had contributed $764,274 to the Bush campaign via their employees and PACs, while Kerry had received six times less, or $149,400.
But $764,274 is but a drop in the bucket when you look at industry profits under Bush. "National sales of anti-psychotics reached $6.4 billion in 2002, making them the fourth-highest-selling class of drugs, behind cholesterol-lowering drugs, ulcer drugs and antidepressants, said IMS Health, a company that tracks drug sales," according to a report by Erica Goode in the May, 2003, New York Times.
In 2002, NDC Health, another watchdog company, determined that "more than 7.4 million prescriptions were written for Zyprexa and more than 7.6 million for Risperdal." Antidepressants and anti-psychotics now constitute two of the four top classes of drug sales.
The Pharmaceutical Industry should branch out into the gambling racket because it definitely knows a sure bet when it sees one.
A new plan by the Bush administration to test the nation's public school population for mental disorders and treat them with controversial drugs has raised an alarm among some medical science watchdogs and members of the mental health community, according to the June 27, 2004, New Standard.
Bush wants to launch a mental health and disability initiative that recommends the screening and treatment for students K-12 in public schools. The plan is based on a Texas program known as the "Texas Mental Health Parity."
The Texas model has been implemented in other states, including Pennsylvania, where a government whistleblower, Allan Jones, has called it "a Trojan horse" for pharmaceutical companies. If enacted on a national level, the scheme would mandate widespread testing all across the country which would result in the recruitment of hundreds of thousands of new customers for the pharmaceutical Industry.
Jones was a state employee in Pennsylvania at the time the program was put into place there. He later became a Whistleblower and says, "the pharmaceutical industry has methodically compromised our political system at all levels and has systematically infiltrated the mental health service delivery system of this nation."
"They are poised to consolidate their grip, via the New Freedom Commission and the Texas Medication Algorithm Project," Jones says. "The pervasive manipulation of clinical trials, the non-reporting of negative trials and the cover-up of debilitating and deadly side effects render meaningful informed consent impossible by persons being treated with these drugs," he warns.
Jones believes that doctors and patients alike have been betrayed by the governmental entities and officials who are supposed to protect them, and I agree 100%.
I was outraged, as I was forced to watch Bush and the drug companies set up a scam to used senior citizens as funnels with the Medicare Prescription Drug Bill. But you can bet that I will not sit back and watch them implement their latest profiteering scheme when it involves drugging my grandkids.
They won't be satisfied until they have every kid in the country drugged. Despite the nearly 500% increase in the number of children being prescribed psychiatric drugs, the administration's, New Freedom Commission on Mental Health (NFC), claims that there are not enough children benefiting from mental health treatment and recommends mandatory screening for all high school students, with follow-up treatment as required.
If Bush has his way, the Texas Medication Algorithm Project (TMAP) will serve as a model for the upcoming nationwide program, according to the NFC.
The TMAP began in 1995, when a group of individuals from the pharmaceutical industry, joined up with officials from the Texas state university, and state mental health and corrections systems. The program’s initial funding included a $1.7 million grant from the Robert Wood Johnson Foundation; and off-shoot of the Johnson & Johnson Pharmaceutical company. Johnson & Johnson owns the drug companies Janssen Pharmaceutica and Janssen/Ortho McNeil, according to “Law Project For Psychiatric Rights,” by Jones.
Its more than obvious that the true goal of this group was to develop a program of drug treatment for use in the juvenile justice system, state foster care program, mental health hospitals, and prison systems, which would generate high volume sales of new expensive drugs. As Texas Governor, Bush supported legislation that required private industry to provide increased insurance coverage for mental health treatment and drugs.
The medication guidelines for the TMAP were established by an "expert consensus" based on the opinions of prescribers, rather than clinical studies. Nearly all of the major drug companies helped fund the scheme, including Eli Lilly, Janssen Pharmaceutica, Johnson & Johnson, Astrazeneca, Novartis, Janssen-Ortho-McNeil, GlaxoSmithKline, Abbott, Pfizer, Bristol Myers Squibb, Wyeth-Ayerst and Forrest Laboratories.
The drugs recommended by the "experts" for "first line treatment,” were the new drugs manufactured by the same companies that funded the scheme and included, Zyprexa, Paxil, Zoloft, Allerall, Risperdal, Seroqual, Depakote, Pozac, Celexa, Wellbutron, Zyban, Remeron, Serzone, Effexor, and Buspar.
The TMAP gave the pharmaceutical industry unlimited access to the Texas prison system, juvenile justice system, foster care program, and state mental health hospitals, by which to expand its customer base and increase the sale of over-priced drugs.
Next, Texas lawmakers passed legislation that would increase Medicaid coverage to persons who would not ordinarily qualify, and increased the state budget to provide funding to pay for drugs prescribed to people within the public systems.
As the Texas program spread to other states, the scam did not go unnoticed. A May, 2004 report by the New York Times, explained how drug companies were using new strategies to capture the Medicaid and Medicare markets that involved a "focus on a much smaller group of customers: state officials who oversee treatment for many people with serious mental illness. Those patients -- in mental hospitals, at mental health clinics and on Medicaid -- make states among the largest buyers of anti-psychotic drugs," the report noted.
By some accounts, between 1999 to 2003, antidepressant prescriptions for children in the US have increased over 500%, often with devastating results. For example, Paxil was one of the new miracle drugs recommended by the TCMAP “expert consensus” panel and prescribed to children even though it was basically untested.
Since then, the drug has been linked to a rising number of dangerous side effects in children, and lawsuits have listed it as a contributing factor in suicide, murder, debilitating injury and school shootings.
In June of 2003, the FDA finally issued a warning that Paxil should not be prescribed for children due to the alarming rise in suicides by children who were taking the drug.
Money, Politics & Drugs
According to the Center for Responsive Politics, in his 2 bids for the presidency, Bush has been the number one recipient of campaign donations from the pharmaceutical industry, in either party. The same Robert Wood Johnson IV, who has ties to the foundation mentioned above, and is also heir to the Johnson & Johnson fortune, raised over $100,000 for Bush’s 2000 campaign, and over $200,000 for campaign 2004.
The next top recipients, were Congressman Mike Ferguson (R-NJ) and Senator John Burr (R-NC), each of whom sits on Energy and Commerce Subcommittees on Health, which oversee mental health and research, biomedical programs, food and drug policies, and Medicaid.
An obvious example of mixing drugs, money & politics, can be found with the drug, Zyprexa. It was one of the drugs recommended in the TMAP. With more than $4 billion in sales worldwide, in 2003, it was Eli Lilly’s top selling drug. In the US, for the most part, tax payers footed the bill for this drug. According to the New York Times, 70% of Zyprexa sales in this country in 2003, were paid for by programs like Medicare and Medicaid.
Its no secret that Eli Lilly has long-standing ties to the Bush administration. At one time, Bush Sr was a member of Lilly's board of directors, and the current President Bush made Lilly CEO, Sidney Taurel, a member of the Homeland Security Council.
In the 2000 election Lilly contributed over $1.5 million to political candidates, with over 80% going to Bush and the Republican Party.
In fact, looking at the total drug company donations during campaign 2004, Bush won by a land slide. According to the Center for Responsive Politics, by April, 2004, manufacturers of drugs and health products had contributed $764,274 to the Bush campaign via their employees and PACs, while Kerry had received six times less, or $149,400.
But $764,274 is but a drop in the bucket when you look at industry profits under Bush. "National sales of anti-psychotics reached $6.4 billion in 2002, making them the fourth-highest-selling class of drugs, behind cholesterol-lowering drugs, ulcer drugs and antidepressants, said IMS Health, a company that tracks drug sales," according to a report by Erica Goode in the May, 2003, New York Times.
In 2002, NDC Health, another watchdog company, determined that "more than 7.4 million prescriptions were written for Zyprexa and more than 7.6 million for Risperdal." Antidepressants and anti-psychotics now constitute two of the four top classes of drug sales.
The Pharmaceutical Industry should branch out into the gambling racket because it definitely knows a sure bet when it sees one.
Bush-Backed Drug Marketing Schemes
Evelyn Pringle April 2005
At an FDA hearing on the safety of psychotropic drugs on Feb 2, 2004, dozens of tortured parents testified that their children had committed suicide or other violent acts after being prescribed the same drugs that are being marketed in the Bush-backed pharmaceutical industry schemes aimed at recruiting the nations 52 million school children as customers.
In July 2003, the Bush appointed New Freedoms Commission on Mental Health (NFC) recommended screening all children for mental illness and designated TeenScreen as a model program to ensure that every student receives a mental health check-up before finishing high school.
The NFC also has a preferred drug program in place modeled after the Texas Medication Algorithm Project (TMAP), that lists what drugs are to be used on children found to be mentally ill.
The list contains every drug that people complained about at the FDA hearing, including Paxil, Zoloft, Celexa, Wellbutron, Zyban, Remeron, Serzone, Effexor, Buspar, Risperdal, Zyprexa, Seroqual, Geodone, Depakote, Adderall, and Prozac.
There is little if any evidence that these drugs work on children but nevertheless, an estimated 10 million children in the US are now taking these mind-altering drugs even though they have documented side-effects including suicidal ideation, mania, psychosis, and future drug dependence.
According to a May 2003 report in the New York Times, national sales of anti-psychotics reached $6.4 billion in 2002, making them the fourth highest-selling class of drugs which proves the drug companies are already making a killing by drugging our kids.
Experts Against Screening
Dr Jane Orient is an internist and executive director of the Association of American Physicians and Surgeons. She offered a few words to the wise in United Press International's "Outside View" on December 16, 2004.
In regard to TeenScreen, Orient says parents ought to be asking some very serious questions before the government experts interview the first child such as:
What are the credentials of the screeners? What are the criteria for possible abnormality? What is the scientific validation? Will you be allowed to get a second opinion? Can you see the record and enter corrections if indicated? Will the record at any point be destroyed, or will the stigma of a diagnosis such as "personality disorder" follow the child throughout life?
What will happen if your child fails the screen? What sort of treatment will be given? Who will supervise it? What if you don't approve of it?
Do drug companies expect to have a large number of new consumers of their psychoactive drugs? Who might profit from the program (perhaps discoverable by asking who lobbied for it)?
Bingo, right question. Who stands to profit?
In 2003, Medico Health Solutions, reports that the use of behavioral drugs for children topped all other types of drugs at 17% of total spending. In the year 2003, the market research firm, IMS Health, calculated worldwide sales of antidepressants at $19.5 billion, up 10% from the year 2002.
Phyllis Schlafly, author of "No Child Left Unmedicated," raises several valid questions. What are the rights of youth and parents to refuse or opt out of such screening? Will they face threats of removal from school, if they refuse privacy-invading interrogations or medications? How will a child remove a stigmatizing label from his records?
Psychiatrist Peter Breggin, a court-qualified medical expert, and author of books, Talking Back to Prozac and The Anti-Depressant Fact Book, warns about the life-long damage a label of mentally illness can cause.
"There is nothing worse that you can do to a human being in America today than give them a mental illness kind of label and tell them they need drugs and these children are 3,4,5,6,7,8,9 years-old being treated in this manner," Breggin reports, "I then see them coming to me as adults saying I'd like to be a doctor but how can I when I have crossed wires in my head," he warns.
In a report, Allen Jones, former investigator Penn Office of Inspector General Bureau of Special Investigations, points out that there has been a 500% increase in children being prescribed drugs during the past 6 years.
Jones says the NFC call for mandatory screening of all students, with follow-up treatment as required, translates into putting more kids on mind-altering and potentially lethal drugs.
"TeenScreen is purely and simply a marketing scam to sell psychotropic drugs," according anti-child drugging advocate, Ken Kramer, "When they use "even if we save one life" as an argument to arouse emotions in parents that truly care, they are lying," he warns.
Bush Promotes Dangerous Drugs
The truth is, with full support from Bush, the pharmaceutical industry is using TeenScreen as a vehicle to push dangerous drugs on children who in the eyes of many experts are already being overmedicated.
Despite that the fact that SSRI antidepressants are banned for use with children in the UK and despite the FDA “black box” warning label now required on all SSRIs that the drugs increase suicidal thinking and behavior in kids, the NFC not only recommends that the same drugs be prescribed to children, it promotes the very schemes that will increase the number of kids on these drugs in schools and other public institutions.
According to a report by the Florida Statewide Advocacy Council, posted on Ken Kramer's website records@psychsearch.net, an investigation in Florida found that of 1,180 kids in foster care, 652 were on one or more psychotropic drugs.
In Texas, Dr John Breeding, an Austin psychologist, has seen cases where some foster children were placed on as many as 17 drugs and says drugs are being used as chemical restraints in Texas. He wants all SSRIs and neuroleptic drugs banned from use on children. "The SSRIs are extremely harmful and addictive; and can cause or exacerbate suicidal or homicidal tendencies; withdrawal is painful and dangerous," Breeding warns.
Dr Ann Blake Tracy is the Director of the International Coalition for Drug Awareness, holds a doctorate in biological psychology, and is a specialist in the adverse reactions to SSRI medications. Tracy claims the whole hypothesis of SSRIs is "backwards."
She says the drugs increase serotonin while decreasing the metabolism of serotonin, especially in the 7 to 10% of the population that studies have shown don't have the proper enzyme to metabolize SSRIs in the first place, according to the Aug 22, 2004 Desert Morning News.
Dr Tracy can recite hundreds of horror stories involving violence by people taking the same drugs that TeenScreen is marketing to more children.
She told the Morning News about "the professor on Prozac who bit her mother to death; the Stanford graduate on Paxil who stabbed herself in the kitchen while her parents slept; the mother who bludgeoned her son and then drank a can of Drano; and the 12-year-old girl who strangled herself with a bungee cord she attached to a plant hanger on the wall."
"Most of these drugs are not approved for children, but it doesn't stop doctors from prescribing them," Tracy points out.
Turning People Into Psychotic Murderers
Besides causing suicide, enough evidence now exists to prove that psychotropic drugs have played a major role in the senseless acts of violence by school-age children in this country in recent years.
Dr Breggin is against the use of psychotropic drugs in children, and has testified in civil and criminal cases numerous times about the link between SSRIs and suicide and other acts of violence.
On April 15, 2001, 16-year-old Cory Baadsgaard took a rifle to his High School in Washington State and held 23 classmates and a teacher hostage. Cory sat in jail for 14 months before finally being released based on expert testimony by psychiatrists that his behavior was an adverse reaction to the drugs he was prescribed.
Cory has no memory of his actions at the school that day. 21 days before the event, he had been taken off Paxil and prescribed a high dose of the drug Effexor.
Cory's father Jay told Insight News, "They always talk about how the kids who do these things are the ones who get picked on by the jocks and stuff, but Cory was a jock. He was on the varsity basketball team, played football and golf, and was very popular in school.
Jay wants the media to warn people about the dangers of putting kids on these drugs, "If Cory had been on PCP the media would say 'Oh, he needs drug rehabilitation,' but because these were prescribed medications they say 'Oh, it can't be that,' but now we know it can be," he said.
"The morning that Cory went to school and did what he did, my wife and I just knew that it had to be something with the drugs," Jay reports. One of Cory's friends described the incident to Jay, "Cory was yelling and then he just stopped, looked down and saw the gun in his hand and woke up," he said.
Cory recently made an unlikely new friend in Colorado, when he met Columbine High School shooting victim, Mark Taylor, who is suing the manufacturer of the antidepressant that Eric Harris was on when he opened fire at Columbine.
Kelly Patricia OMeara interviewed Mark Taylor, and recounted his description of the shooting incident in a report for Insight on Sept 2, 2002.
Taylor told Kelly, "I was sitting on a hill outside the school eating lunch with my best friend when Eric Harris came over and started shooting me."
"I was shot between seven and 13 times. No one really knows the exact number because there were so many bullet tracks. Most of the bullets just went right through me. After I was shot I just lay there, playing dead, and could see others being shot," he recounted.
It has never been revealed if Dylan Klebold was on any legal drugs at the time of the shootings, but an autopsy revealed that Harris was on the psychotropic drug Luvox, a selective serotonin reuptake inhibitor (SSRI).
Taylor's attitude toward the teen who nearly killed him is surprising. He told O Meara, "I'm suing Solvay because I believe that Eric Harris did what he did because of this drug."
Taylor's suit claims the drug made Harris manic and psychotic and as a consultant in the suit, Dr Tracy agrees. "All you have to do is read the Luvox package insert to see that Eric's actions were due to an adverse reaction to this drug," she told Insight News, "Show me a drug anywhere that has listed mania and psychosis as frequent adverse reactions. That is what the insert says for Luvox. There is no doubt in my mind that Luvox caused Eric Harris to commit these acts," she explained.
Gary Null & Associates of New York is filming a documentary called “The Drugging of Our Children,” that will feature interviews with both Cory Baadsgaard and Mark Taylor, and will chronicle the long history of tragic events that have resulted from the use of these drugs on children.
A little known fact is that a few days before the Columbine tragedy, Eric Harris had been rejected by the Marine Corps specifically because he was taking the drug Luvox.
In 2001, 18-year-old Jason Hoffman, shot five students and teachers at a California High School, while on the drugs Celexa and Effexor, and he too was rejected by the Navy one day before he went on his rampage, according to the San Diego Union-Tribune.
In a letter to his mother, Hoffman said, "I want people to know that what happened was not the real me, I was just angry, maybe my medication. It was a fluke of the moment. The person was not the true Jason Hoffman," he wrote.
On Oct 29, 2001, Jason Hoffman killed himself by hanging from a vent screen in his jail cell, the Tribune reported.
Kip Kinkel was 15 on May 21, 1998, when he murdered his parents, and then went to Thurston High School in Springfield, OR where he shot and killed 2 students and injured 22 more. Kinkel was on Ritalin and Prozac at the time of the killings even though Prozac was not approved for pediatric use.
Seven years after the senseless killings by Kinkel, on December 18, 2003, Eli Lilly sent letters to British healthcare providers, warning that Prozac was not recommended for any use in children.
14 year-old Elizabeth Bush was on antidepressants when she took a gun to school and wounded another student in Williamsport, PA in 2001.
12-year-old Christopher Pittman was on Zoloft when he shot his grandparents and set their house on fire, and says his violence was caused by the drug he was. Before Zoloft, he had been on Paxil.
According to court records, the doctor who prescribed the drug to Christopher mentioned no problems in his medical notes. A few days before the murders, the doctor wrote: "Lots of energy. No plans to harm self. Not flying off the handle."
Christopher now sits in prison.
His father, Joe Pittman, testified about the effects of the drugs on his son at the FDA Hearing and read a letter Christopher wrote that described how he felt when he committed the murders, "Through the whole thing, it was like watching your favorite TV show," he wrote, "You know what is going to happen but you can't do anything to stop it."
Dr Tracy explains how this happens. SSRIs suppress "the REM state or dream state [of sleep] ... These drugs allow a person to be awake but at any time they can slip into the REM state. This is why people often discuss how they couldn't tell the difference between the dream and reality. These drugs are horribly damaging to the entire system," she warns.
Even the people closest to Jeff Weise are at a loss to say what led to the deadly killing spree by Weise in Minnesota, where the 16-year-old shot his grandfather, his companion, and then went to the high school and shot 5 students, a teacher and a security guard before killing himself. According to school employee, Gayle Downwind, Weise was on Prozac at the time of the shootings.
Dr Tracy has consulted on many cases where children engaged in violent behavior including a 15-year-old boy on Zoloft who shot and killed a woman and is serving life in prison; a 17-year-old boy on Paxil for three months who jumped off an overpass into the path of a trailer truck; a 14-year-old girl prescribed Paxil to deal with the suicide of her father (who was on Paxil before killing himself) drank Drano in a suicide attempt; and a 16-year-old boy on Paxil who stabbed a woman over 60 times, drove his car into a cement abutment in a failed suicide attempt, and is now serving life in prison.
"In each of these cases," Tracy told Insight News, "individuals close to them were shocked at the violent and destructive behavior because it was so out of character for them."
Courts Starting to Get It
Drug companies are finally starting to be held responsible for violent behavior associated with these drugs. A jury in Cheyenne, Wyoming recently determined that Paxil, "can cause some individuals to commit suicide and/or homicide." The jury decided Paxil caused Donald Schell to shoot his wife, daughter and granddaughter before killing himself after being on the drug only two days.
The jury allocated 80% of the fault on Paxil drug maker GlaxoSmithKline and awarded the surviving family members $8 million in damages.
On June 18, 2003, GlaxSmithKline issued a warning to British physicians against the use of Paxil in children, acknowledging failure of clinical trials "to demonstrate efficacy in major depressive disorders and doubling the rate of reported adverse events - including suicidal thoughts and suicide attempts - compared to placebo."
In Bismarck, ND, 10 days after Ryan Ehlis began taking Adderall, he shot and killed his 5-week-old baby and then turned the gun on himself. He survived and was tried for the murder but was acquitted after the Judge agreed with psychiatrists who testified that the murder resulted solely from a psychotic state caused by the drug.
In February 2005, Canadian regulators ordered Adderall off the market after the drug was linked to 20 sudden deaths and a dozen strokes. Of the 20 deaths, 14 were children.
There has been a lot written about the increase in teen violence and school shootings but no one has identified a common denominator in the lives of these kids with one exception, the drugs. If we allow the Bush-backed marketing schemes to succeed in recruiting more kids as customers for these dangerous drugs, according to Tracy, we had better prepare for more of the same.
"We've got a nightmare on our hands with these drugs, an absolute nightmare," she warns, "We've got kids on these drugs that are ticking time bombs in every school in America."
"When all of this is over and we count up the dead, we're going to be in shock," she adds.
At an FDA hearing on the safety of psychotropic drugs on Feb 2, 2004, dozens of tortured parents testified that their children had committed suicide or other violent acts after being prescribed the same drugs that are being marketed in the Bush-backed pharmaceutical industry schemes aimed at recruiting the nations 52 million school children as customers.
In July 2003, the Bush appointed New Freedoms Commission on Mental Health (NFC) recommended screening all children for mental illness and designated TeenScreen as a model program to ensure that every student receives a mental health check-up before finishing high school.
The NFC also has a preferred drug program in place modeled after the Texas Medication Algorithm Project (TMAP), that lists what drugs are to be used on children found to be mentally ill.
The list contains every drug that people complained about at the FDA hearing, including Paxil, Zoloft, Celexa, Wellbutron, Zyban, Remeron, Serzone, Effexor, Buspar, Risperdal, Zyprexa, Seroqual, Geodone, Depakote, Adderall, and Prozac.
There is little if any evidence that these drugs work on children but nevertheless, an estimated 10 million children in the US are now taking these mind-altering drugs even though they have documented side-effects including suicidal ideation, mania, psychosis, and future drug dependence.
According to a May 2003 report in the New York Times, national sales of anti-psychotics reached $6.4 billion in 2002, making them the fourth highest-selling class of drugs which proves the drug companies are already making a killing by drugging our kids.
Experts Against Screening
Dr Jane Orient is an internist and executive director of the Association of American Physicians and Surgeons. She offered a few words to the wise in United Press International's "Outside View" on December 16, 2004.
In regard to TeenScreen, Orient says parents ought to be asking some very serious questions before the government experts interview the first child such as:
What are the credentials of the screeners? What are the criteria for possible abnormality? What is the scientific validation? Will you be allowed to get a second opinion? Can you see the record and enter corrections if indicated? Will the record at any point be destroyed, or will the stigma of a diagnosis such as "personality disorder" follow the child throughout life?
What will happen if your child fails the screen? What sort of treatment will be given? Who will supervise it? What if you don't approve of it?
Do drug companies expect to have a large number of new consumers of their psychoactive drugs? Who might profit from the program (perhaps discoverable by asking who lobbied for it)?
Bingo, right question. Who stands to profit?
In 2003, Medico Health Solutions, reports that the use of behavioral drugs for children topped all other types of drugs at 17% of total spending. In the year 2003, the market research firm, IMS Health, calculated worldwide sales of antidepressants at $19.5 billion, up 10% from the year 2002.
Phyllis Schlafly, author of "No Child Left Unmedicated," raises several valid questions. What are the rights of youth and parents to refuse or opt out of such screening? Will they face threats of removal from school, if they refuse privacy-invading interrogations or medications? How will a child remove a stigmatizing label from his records?
Psychiatrist Peter Breggin, a court-qualified medical expert, and author of books, Talking Back to Prozac and The Anti-Depressant Fact Book, warns about the life-long damage a label of mentally illness can cause.
"There is nothing worse that you can do to a human being in America today than give them a mental illness kind of label and tell them they need drugs and these children are 3,4,5,6,7,8,9 years-old being treated in this manner," Breggin reports, "I then see them coming to me as adults saying I'd like to be a doctor but how can I when I have crossed wires in my head," he warns.
In a report, Allen Jones, former investigator Penn Office of Inspector General Bureau of Special Investigations, points out that there has been a 500% increase in children being prescribed drugs during the past 6 years.
Jones says the NFC call for mandatory screening of all students, with follow-up treatment as required, translates into putting more kids on mind-altering and potentially lethal drugs.
"TeenScreen is purely and simply a marketing scam to sell psychotropic drugs," according anti-child drugging advocate, Ken Kramer, "When they use "even if we save one life" as an argument to arouse emotions in parents that truly care, they are lying," he warns.
Bush Promotes Dangerous Drugs
The truth is, with full support from Bush, the pharmaceutical industry is using TeenScreen as a vehicle to push dangerous drugs on children who in the eyes of many experts are already being overmedicated.
Despite that the fact that SSRI antidepressants are banned for use with children in the UK and despite the FDA “black box” warning label now required on all SSRIs that the drugs increase suicidal thinking and behavior in kids, the NFC not only recommends that the same drugs be prescribed to children, it promotes the very schemes that will increase the number of kids on these drugs in schools and other public institutions.
According to a report by the Florida Statewide Advocacy Council, posted on Ken Kramer's website records@psychsearch.net, an investigation in Florida found that of 1,180 kids in foster care, 652 were on one or more psychotropic drugs.
In Texas, Dr John Breeding, an Austin psychologist, has seen cases where some foster children were placed on as many as 17 drugs and says drugs are being used as chemical restraints in Texas. He wants all SSRIs and neuroleptic drugs banned from use on children. "The SSRIs are extremely harmful and addictive; and can cause or exacerbate suicidal or homicidal tendencies; withdrawal is painful and dangerous," Breeding warns.
Dr Ann Blake Tracy is the Director of the International Coalition for Drug Awareness, holds a doctorate in biological psychology, and is a specialist in the adverse reactions to SSRI medications. Tracy claims the whole hypothesis of SSRIs is "backwards."
She says the drugs increase serotonin while decreasing the metabolism of serotonin, especially in the 7 to 10% of the population that studies have shown don't have the proper enzyme to metabolize SSRIs in the first place, according to the Aug 22, 2004 Desert Morning News.
Dr Tracy can recite hundreds of horror stories involving violence by people taking the same drugs that TeenScreen is marketing to more children.
She told the Morning News about "the professor on Prozac who bit her mother to death; the Stanford graduate on Paxil who stabbed herself in the kitchen while her parents slept; the mother who bludgeoned her son and then drank a can of Drano; and the 12-year-old girl who strangled herself with a bungee cord she attached to a plant hanger on the wall."
"Most of these drugs are not approved for children, but it doesn't stop doctors from prescribing them," Tracy points out.
Turning People Into Psychotic Murderers
Besides causing suicide, enough evidence now exists to prove that psychotropic drugs have played a major role in the senseless acts of violence by school-age children in this country in recent years.
Dr Breggin is against the use of psychotropic drugs in children, and has testified in civil and criminal cases numerous times about the link between SSRIs and suicide and other acts of violence.
On April 15, 2001, 16-year-old Cory Baadsgaard took a rifle to his High School in Washington State and held 23 classmates and a teacher hostage. Cory sat in jail for 14 months before finally being released based on expert testimony by psychiatrists that his behavior was an adverse reaction to the drugs he was prescribed.
Cory has no memory of his actions at the school that day. 21 days before the event, he had been taken off Paxil and prescribed a high dose of the drug Effexor.
Cory's father Jay told Insight News, "They always talk about how the kids who do these things are the ones who get picked on by the jocks and stuff, but Cory was a jock. He was on the varsity basketball team, played football and golf, and was very popular in school.
Jay wants the media to warn people about the dangers of putting kids on these drugs, "If Cory had been on PCP the media would say 'Oh, he needs drug rehabilitation,' but because these were prescribed medications they say 'Oh, it can't be that,' but now we know it can be," he said.
"The morning that Cory went to school and did what he did, my wife and I just knew that it had to be something with the drugs," Jay reports. One of Cory's friends described the incident to Jay, "Cory was yelling and then he just stopped, looked down and saw the gun in his hand and woke up," he said.
Cory recently made an unlikely new friend in Colorado, when he met Columbine High School shooting victim, Mark Taylor, who is suing the manufacturer of the antidepressant that Eric Harris was on when he opened fire at Columbine.
Kelly Patricia OMeara interviewed Mark Taylor, and recounted his description of the shooting incident in a report for Insight on Sept 2, 2002.
Taylor told Kelly, "I was sitting on a hill outside the school eating lunch with my best friend when Eric Harris came over and started shooting me."
"I was shot between seven and 13 times. No one really knows the exact number because there were so many bullet tracks. Most of the bullets just went right through me. After I was shot I just lay there, playing dead, and could see others being shot," he recounted.
It has never been revealed if Dylan Klebold was on any legal drugs at the time of the shootings, but an autopsy revealed that Harris was on the psychotropic drug Luvox, a selective serotonin reuptake inhibitor (SSRI).
Taylor's attitude toward the teen who nearly killed him is surprising. He told O Meara, "I'm suing Solvay because I believe that Eric Harris did what he did because of this drug."
Taylor's suit claims the drug made Harris manic and psychotic and as a consultant in the suit, Dr Tracy agrees. "All you have to do is read the Luvox package insert to see that Eric's actions were due to an adverse reaction to this drug," she told Insight News, "Show me a drug anywhere that has listed mania and psychosis as frequent adverse reactions. That is what the insert says for Luvox. There is no doubt in my mind that Luvox caused Eric Harris to commit these acts," she explained.
Gary Null & Associates of New York is filming a documentary called “The Drugging of Our Children,” that will feature interviews with both Cory Baadsgaard and Mark Taylor, and will chronicle the long history of tragic events that have resulted from the use of these drugs on children.
A little known fact is that a few days before the Columbine tragedy, Eric Harris had been rejected by the Marine Corps specifically because he was taking the drug Luvox.
In 2001, 18-year-old Jason Hoffman, shot five students and teachers at a California High School, while on the drugs Celexa and Effexor, and he too was rejected by the Navy one day before he went on his rampage, according to the San Diego Union-Tribune.
In a letter to his mother, Hoffman said, "I want people to know that what happened was not the real me, I was just angry, maybe my medication. It was a fluke of the moment. The person was not the true Jason Hoffman," he wrote.
On Oct 29, 2001, Jason Hoffman killed himself by hanging from a vent screen in his jail cell, the Tribune reported.
Kip Kinkel was 15 on May 21, 1998, when he murdered his parents, and then went to Thurston High School in Springfield, OR where he shot and killed 2 students and injured 22 more. Kinkel was on Ritalin and Prozac at the time of the killings even though Prozac was not approved for pediatric use.
Seven years after the senseless killings by Kinkel, on December 18, 2003, Eli Lilly sent letters to British healthcare providers, warning that Prozac was not recommended for any use in children.
14 year-old Elizabeth Bush was on antidepressants when she took a gun to school and wounded another student in Williamsport, PA in 2001.
12-year-old Christopher Pittman was on Zoloft when he shot his grandparents and set their house on fire, and says his violence was caused by the drug he was. Before Zoloft, he had been on Paxil.
According to court records, the doctor who prescribed the drug to Christopher mentioned no problems in his medical notes. A few days before the murders, the doctor wrote: "Lots of energy. No plans to harm self. Not flying off the handle."
Christopher now sits in prison.
His father, Joe Pittman, testified about the effects of the drugs on his son at the FDA Hearing and read a letter Christopher wrote that described how he felt when he committed the murders, "Through the whole thing, it was like watching your favorite TV show," he wrote, "You know what is going to happen but you can't do anything to stop it."
Dr Tracy explains how this happens. SSRIs suppress "the REM state or dream state [of sleep] ... These drugs allow a person to be awake but at any time they can slip into the REM state. This is why people often discuss how they couldn't tell the difference between the dream and reality. These drugs are horribly damaging to the entire system," she warns.
Even the people closest to Jeff Weise are at a loss to say what led to the deadly killing spree by Weise in Minnesota, where the 16-year-old shot his grandfather, his companion, and then went to the high school and shot 5 students, a teacher and a security guard before killing himself. According to school employee, Gayle Downwind, Weise was on Prozac at the time of the shootings.
Dr Tracy has consulted on many cases where children engaged in violent behavior including a 15-year-old boy on Zoloft who shot and killed a woman and is serving life in prison; a 17-year-old boy on Paxil for three months who jumped off an overpass into the path of a trailer truck; a 14-year-old girl prescribed Paxil to deal with the suicide of her father (who was on Paxil before killing himself) drank Drano in a suicide attempt; and a 16-year-old boy on Paxil who stabbed a woman over 60 times, drove his car into a cement abutment in a failed suicide attempt, and is now serving life in prison.
"In each of these cases," Tracy told Insight News, "individuals close to them were shocked at the violent and destructive behavior because it was so out of character for them."
Courts Starting to Get It
Drug companies are finally starting to be held responsible for violent behavior associated with these drugs. A jury in Cheyenne, Wyoming recently determined that Paxil, "can cause some individuals to commit suicide and/or homicide." The jury decided Paxil caused Donald Schell to shoot his wife, daughter and granddaughter before killing himself after being on the drug only two days.
The jury allocated 80% of the fault on Paxil drug maker GlaxoSmithKline and awarded the surviving family members $8 million in damages.
On June 18, 2003, GlaxSmithKline issued a warning to British physicians against the use of Paxil in children, acknowledging failure of clinical trials "to demonstrate efficacy in major depressive disorders and doubling the rate of reported adverse events - including suicidal thoughts and suicide attempts - compared to placebo."
In Bismarck, ND, 10 days after Ryan Ehlis began taking Adderall, he shot and killed his 5-week-old baby and then turned the gun on himself. He survived and was tried for the murder but was acquitted after the Judge agreed with psychiatrists who testified that the murder resulted solely from a psychotic state caused by the drug.
In February 2005, Canadian regulators ordered Adderall off the market after the drug was linked to 20 sudden deaths and a dozen strokes. Of the 20 deaths, 14 were children.
There has been a lot written about the increase in teen violence and school shootings but no one has identified a common denominator in the lives of these kids with one exception, the drugs. If we allow the Bush-backed marketing schemes to succeed in recruiting more kids as customers for these dangerous drugs, according to Tracy, we had better prepare for more of the same.
"We've got a nightmare on our hands with these drugs, an absolute nightmare," she warns, "We've got kids on these drugs that are ticking time bombs in every school in America."
"When all of this is over and we count up the dead, we're going to be in shock," she adds.
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