The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part I

Evelyn Pringle August 30, 2007

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part II

Evelyn Pringle September 2, 2007

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration say children younger than 6 should generally not be given psychotropic drugs and they should “only be considered under the most extraordinary of circumstances.”

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lawmakers Want to End Big Pharma Recruitment Schemes – Part 2

Evelyn Pringle May 30, 2007

The whole idea of mining for psychiatric drug customers by screening all Americans for mental health disorders came to fruition as the result of the campaign contributions by the pharmaceutical industry, which in large part helped George W Bush take up residence in the White House.

To repay his enormous debt to the industry, on April 29, 2002, Bush paved the way for the implementation of the industry-funded screening programs and the mass drugging-for-profit scheme when he created the New Freedom Commission.

According to Dr Nathaniel Lehrman, former clinical director of Kingsboro Psychiatric Center, in Brooklyn NY, in the paper, The Dangers of Mental Health Screening, It is merely one of the “Bush administration hand-outs to the drug companies, so many of which have changed from legitimate businesses into patent-protected rackets.”

The recruitment of children as customers was a central goal of the industry, and Bush came through in helping meet that goal. The NFC’s final report dated July 22, 2003, called for screening every American child for mental illness, including preschoolers, and said, “schools are in a key position to identify mental health problems early and to provide a link to appropriate services.”

To that end, the report says, every child involved in a government program or is covered by Medicaid will automatically be screened under the following recommendation: “Screening should be implemented upon entry into, and periodically thereafter in, the juvenile justice and child welfare systems, as well as in other settings and populations with known high risk, such as the Medicaid population.”

The report also specifically calls for screening programs to be linked to “state-of-the-art treatments” using “specific medications for specific conditions.” A fact not mentioned is that 95% of the “specific medications” referred to were not FDA approved for treating children and have never been tested as safe and effective with children.

In addition, recent studies have shown that, although the rise in numbers of patients taking psychiatric drugs has skyrocketed over the past decade, there has been no decrease in mental illness. To the contrary, judging by the company sales figures, the man-made epidemic is still spreading like a wildfire.

But worst of all, for all the money spent and the stream of new serious side effect emerging each year, no patients are recovering from their alleged “mental disorders.”

The screening program recommended by Bush’s Commission for use in the public school system was TeenScreen, which created a controversy all across the country when the survey began being administered to students without the knowledge or consent of the parents.

TeenScreen claims it can identify several mental disorders. On March 2, 2004, while trying to drum up federal funding at a Congressional hearing, TeenScreen’s Executive Director, Laurie Flynn, testified that, in the screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality.”

Critics disagree. “The TeenScreen program is a fraud,” says Dr Lehrman. “It makes ‘mental cases’ rather than finding them by giving youngsters brain-injuring medicines.”

The Citizens Commission for Human Rights points out that “human beings have been bumping and bumbling their way through adolescence for a few hundred thousand years, at least.”

“Now TeenScreen and its allies,” it says, “want to turn that right of passage into a profit center of psychiatrists and their allied pharmaceutical companies,” in the November 2006 report, “TeenScreen: Life Saving Intervention, or Orwellian Nightmares?”

In addition, critics say any label of mental illness will have many life-long adverse effects on these children. They will have problems filling out job applications and applying for insurance when they have to say they were diagnosed mentally ill in childhood.

And this will especially be true for those children who have to reveal that the drugs they were prescribed as a child were atypical antipsychotics used to treat schizophrenia or bipolar disorder leading most people to logically conclude that the person has a life-long mental illness.

The atypicals include Zyprexa, Risperdal, Clozaril, Abilify, Seroquel and Geodon, none of which are FDA approved for any use with children and are only approved for treating schizophrenia and manic episodes of bipolar disorder in adults.

Think about it. What do most people think of when they hear the term schizophrenia? Rightly or wrongly, they envision people who are delusional, hear voices, unpredictable and violent. In other words, the person is at least bizarre and at worst dangerous to be around.

And also, there is no denying that such a label results in stigmatism for life, because when do we ever hear that a person “used to have” schizophrenia or bipolar disorder? By design, the drug companies are setting up children to become life-long customers by having them labeled with the most serious of mental disorders.

For nearly 20 years, the drug makers have been raking in profits by promoting the selective serotonin reuptake inhibitor antidepressants (SSRIs) which include Zoloft, Prozac, Paxil, Celexa, Lexapro and Luvox, as working better than the older drugs and concealing the association between the drugs and suicidality.

“Parents must be better informed,” according to a report by The Citizens Commission on Human Rights.

“Few, if any, parents faced with the school situation of their child being labeled as ‘mentally ill’ or ‘learning disordered’ and coerced into taking psychiatric drugs, are told that there are many other factors that could be causing the child’s inattention, behavior problems or learning difficulties,” CCHR states.

“Common causes,” the report says, “are poor reading and math skills requiring tutoring, environmental toxins, allergies, nutritional deficiencies, and other easily detectable and treatable physical conditions.”

Special medical doctors can do tests to determine if a person is experiencing an allergic reaction, and diet can also help, the report notes.

Critics who have investigated the TeenScreen program say it is being sold to the public by the funneling of millions of industry dollars through front groups posing as patient advocacy groups. “The National Alliance for Mental Illness (NAMI),” Mr Kramer says, “pushes suicide screening of children nationwide and receives millions in drug money.”

NAMI received $544,500 from Eli Lilly in the first quarter of this year alone, he notes.

The industry definitely gets a lot of bang for the buck when using NAMI and other front groups. Internationally known expert and author of many books on psychotropic drugs, psychiatrist, Dr Peter Breggin, founder of The International Center for the Study of Psychiatry and Psychology (ICSPP), says groups like NAMI hold national meetings that bring together drug advocates to talk directly to consumers.

“They also send out newsletters and other information that praise the drugs,” he says.

“Sometimes,” he adds, “they actively suppress viewpoints that are critical of drugs, for example, by discouraging the media from airing opposing viewpoints.”

According to Mr Kramer, the TeenScreen advisory board also has major ties to the pharmaceutical industry.

Psychiatrist David Shaffer, who is credited with the development of the TeenScreen survey, is a paid consultant for GlaxoSmithKline on the matter of Paxil and adolescent suicide and has served as an expert witness in lawsuits against plaintiffs injured by pharmaceutical products on behalf of Hoffman la Roche and Wyeth Pharmaceuticals.

In January 2004, Shaffer co-authored a report in the Journal of the American College of Neuropsychopharmacology that claimed, “SSRI antidepressants do not increase the risk of suicidal thinking or suicide attempts in youth.”

By design, the report coincided with the scheduled FDA advisory committee hearings on the issue of whether SSRI use was associated with suicidality in children, and all authors but one had extensive ties to the industry. In the end, the panel ignored Shaffer’s bogus study and determined that a black box warning should be added to SSRI labels.

A few months later, on December 9, 2004, ABC’s Prime Time Live revealed that at least 100 children in the US had committed suicide while taking these new antidepressants and many more had attempted suicide.

The fact that SSRIs cause violence in some people was also concealed by the drug makers for years. As far back as November 2002, Fox News reported that 7 of the 12 teens involved in school shootings were either taking SSRIs or stimulants or were experiencing the withdrawal effects from the drugs and that the possible drug use by the other 5 shooters was unknown at the time because their medical records were sealed. Columbine shooter Eric Harris was on Luvox.

Critics say it’s no coincidence that TeenScreen leader Laurie Flynn was the CEO of NAMI for 16 years before she was promoted to head TeenScreen.

Under Flynn, CCHR reports, NAMI became a virtual marketing arm of the industry, stating in its Guidelines for the Relationship between NAMI and the Campaign’s Founding Sponsors: “Providers, health plans, and pharmaceutical companies want to grow their markets and to increase their share of the market…NAMI will cooperate with these entities to grow the market by making persons aware of the issues involving severe brain disorders…and by helping persons to adhere to their treatment plans.”

An Indiana mother, Teresa Rhodes, has created an online petition against TeenScreen after her 15-year-old daughter, Chelsea, was screened at school without parental consent and was falsely labeled with not one but 2 mental illnesses, obsessive-compulsive disorder and social anxiety disorder. People wishing to sign the petition can do so by clicking on this link http://www.petitiononline.com/TScreen/petition.html.

Mr Kramer says the petition is an excellent way to educate people about TeenScreen because it conveys many of the facts about mental health screening and can be printed off and presented to school board members and local, state and federal legislators.

Activist Vince Boehm has been advocating against screening and the drugging of children for more years than he would like to count. However, he got especially upset recently while watching a discussion on TV about the positive business outlook for the sale of psychiatric drugs to children.

“I was listening to the Bloomberg Business Channel recently,” he says, “and caught an interview with a drug company sales executive.”

“He was talking about how his market share for psychiatric drugs was booming in the pediatric market,” he recalled.

“Then I thought about the children,” Vince said and screamed at the TV, “You jackass! (I actually used a somewhat stronger expletive), these are not ‘market shares’ they are kids!”

According to Laurie Yorke, “Pandora’s Box is an understatement when it comes to mental health screening.”

Laurie is a Registered Nurse whose son was labeled mentally ill and prescribed Paxil and experienced a severe withdrawal syndrome when he stopped taking the drug.

“I think one thing that is never mentioned with TeenScreen,” she states, “is how is the school going to handle a child who has been labeled?”

“What if a child is diagnosed with an ‘anxiety disorder,’ she points out. “Is the school prepared to provide home instruction, smaller classrooms, or whatever is required to educate that child?”

“I bring this up,” she notes, “because Ryan’s school denied his withdrawal from Paxil, accused me of ‘working the system’ and attacked my reputation to all who would listen and finally withdrew his home instruction.”

As a result, Laurie says, her son withdrew from high school altogether. “If this is how they treat someone who is ‘labeled,’” she asks, “how are they going to provide an education for all of those who are being labeled because of TeenScreen?”

In addition, she points out, “how are they going to handle all the children suffering from adverse effects from a drug that they have been prescribed as a result of TeenScreen?”

On May 17, 2007, Laurie testified at a hearing in support of a New Jersey legislative bill that requires physicians and other prescribers to obtain informed consent from parents or guardians of minors who are prescribed psychotropic medication with “black box warnings,” to include informing the parent or guardian of all the potential adverse events associated with the drug.

The bill specifies that a physician or other authorized prescriber who prescribes a medication in violation of this act shall be subject to disciplinary action by the State Board of Medical Examiners. The bill was approved by the State Assembly’s Consumer Affairs Committee.

Before allowing children to take SSRIs, Mr Kramer recommends that at the very least, everyone should get educated on the black box warning which states: “Antidepressants increase the risk of suicidal thinking and behavior in children and adolescents.”

“This FDA warning alone,” he notes, “should be a wake-up call for any true suicide prevention effort.”

The Alliance for Human Research Protection is taking activism a step further by kicking off a campaign urging restrictions on off-label use of all drugs that carry black box warnings.

“Inasmuch as these drugs are deemed by the FDA to carry life-threatening risks of harm,” says AHRP director Vera Hassner Sharav, “their use should be restricted and off-label prescribing of these drugs should be off-limits!”

Bush’s plan for screening the nation’s roughly 36 million senior citizens is set up through the “Positive Aging Act of 2005.” The Act provides federal tax dollars for community-based outreach teams to hunt down the elderly wherever they can be found whether it be at senior citizen centers, adult day care programs, or assisted living facilities.

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

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

Evelyn Pringle June 17, 2006

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.”

Filed under: 2006, TMAP, whistleblower

Neurontin Deal a Slap On The Hand To Pfizer

Evelyn Pringle May 25, 2006

The off-label prescribing of drugs has become a serious problem over the past decade. Doctors are adjusting dosage levels and prescribing drugs for medical indications and treatment durations for which the drugs were never approved or intended.

When the FDA approves a drug, it also approves the labeling for the drug, which explains the manner in which the medication is to be used. While physicians may prescribe approved drugs as they see fit, its against the law for drug companies to promote drugs for uses outside of the approved labeling, but they do it all the time.

Neurontin remains the most notorious example of an illegal, but highly successful, off-label marketing campaign. The drug was approved for the limited use of treating epileptic seizures but nonetheless, became an overnight blockbuster with sales that soared from $97.5 million in 1995, to more than $2.5 billion in 2003.

While Neurontin might be the most notorious, it is certainly not the only problem. A study published in the May 8, 2006, Archives of Internal Medicine, determined that more than one out of every 7 prescriptions written for 160 commonly used drugs were for off-label uses that lacked scientific support.

The study was based on information from the IMS Health National Disease and Therapeutic Index that defines drug prescribing patterns and provides market data on drug companies.

In 2001, an estimated 150 million prescriptions, or 21% of prescriptions written, were for off-label use, according to the Archives study.

To reach its results, the study first determined whether a prescription was off-label and then assessed the level of available scientific evidence supporting the use, through the Drugdex system, a comprehensive summary of evidence supporting off-label uses of prescription drugs.

The study found that 73%, or 109 million off-label prescriptions, had little or no supporting evidence. The study does not explain why doctors prescribe so many drugs off-label but one explanation may be that “both physicians and patients have misunderstood the role of the FDA,” the study’s lead author Randall Stafford says.

“I think there’s sort of a presumption that if a drug has made it onto the market,” he notes, “the FDA has vouched for its safety and efficacy for all of its potential uses.”

One way drug companies have been able to increase the off-label sale of drugs is by influencing doctors in public institutions, and state policy makers, who are involved in the development of drug formularies that list which drugs will be used in state institutions and by persons covered by government health care programs like Medicaid and Medicare.

Allen Jones, a former Pennsylvania fraud investigator, explains that each state has a menu of approved drugs that doctors must prescribe to persons in state institutions. “Before a drug can be prescribed by a state physician for somebody in the state system,” he says, “it has to be on the list.”

According to Mr Jones, the drug companies “have bought the decision-making process from our government officials all the way down to the guy who decides what drugs get on the formulary.”

Doctors who sit on the expert panels and decide which drugs will be on the lists, he says, are paid by drug companies to give positive opinions in order to circumvent the FDA approval process.

“The FDA has no control over what an individual doctor does or says,” Mr Jones explains, “the pharmaceutical industry has funded a mechanism whereby they can gather favorable opinions.”

“They then amplify and magnify those opinions,” he says, “and put them in the form of a treatment protocol that can be implemented in any state with the approval of a few key decision-makers.”

Stacking the deck with industry friendly “experts” is apparently common. An investigation by the scientific journal Nature found “extensive” financial connections between drug companies and the advisory panels, with as many as 70% of the panels affected. In one instance, Nature found every member of a panel had received payments from the company making the drug that was recommended.

In the summer of 2002, Mr Jones discovered an off-the-books account where drug companies were depositing “educational grants” from which state officials and policy makers involved in developing Pennsylvania’s drug list were receiving payments.

“We had state officials accepting $2,000 honorariums,” he noted, “and physicians who were taking trips, perks and gratuities.”

One of the officials Mr Jones named in his investigation was the state pharmacist, Steven Fiorello. In April 2005, the State Ethics Commission fined Fiorello over $27,000 after finding that he repeatedly took money from drug makers, Pfizer and Janssen, while serving on the panel that decided which drugs could be given at 9 state mental hospitals. The commission’s report cited repeated failures to disclose his income from the drug companies.

On June 10, 2005, Senators Chuck Grassley and Max Baucus announced the beginning of an investigation by the Senate Finance Committee, which has oversight responsibility for government health care programs, into the practice where drug companies give money to state governments.

“The drug companies call the awards educational grants,” their press release said, “but the senators are concerned that the dollars are more focused on product promotion than education.”

The Senators said their inquiry was based on reports that companies have awarded grants as inducements to prescribe medications the companies produce.

In some cases, they said, “such grants to state agencies may have prompted those agencies to develop programs leading to over-medication of patients at the expense of patient health or to unnecessary expense for taxpayers.”

“We need to know how this behind-the-scenes funneling of money is influencing decision makers,” Senator Grassley said. “The decisions result in the government spending billions of dollars on drugs.”

In recent years, investigations into the prescribing patterns for people on Medicaid and Medicare has led to the discovery of a drastic increase in off-label prescribing to children and the elderly, of drugs never approved for use with children and the elderly.

One class of drugs found to be prescribed off-label most often without scientific support are psychiatric medications. In 96% of the psychiatric drugs prescribed off-label, the Archive study found support was lacking.

According to the report, Death by Medicine (2003), by Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD, a study on prescription drug use by the elderly conducted by Medco Health Solutions found that 6.3 million senior citizens received more than 160 million prescriptions and a total of 7.9 million medical alerts were triggered by off-label prescribing, with 2.2 million alerts indicating excessive dosages unsuitable for seniors, and about 2.4 million indicating clinically inappropriate drugs for the elderly.

Drug companies have promoted the off-label use of psychiatric drugs with children even after their own studies have shown the drugs to be dangerous. In 2004, New York attorney general, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline for withholding studies that raised doubts about the effectiveness and safety of Paxil in treating children, and revealed that more than 2 million prescriptions for Paxil were written off-label to treat children in 2002.

In late 2004 the FDA ordered black box warnings on all SSRI antidepressants after it was discovered that drug makers had suppressed studies that showed the drugs were linked to an increased risk of suicide in children.

Documents that have surfaced during litigation reveal that drug makers knew about this risk before the SSRI antidepressants arrived on the market but continued to find ways to get doctors to prescribe the drugs to kids. A report by Express Scripts, Inc, a pharmacy benefit manager, titled “Trends in the Use of Antidepressants in a National Sample of Commercially Insured Pediatric Patients,” shows that between 1998 and 2002, the overall use of antidepressants among children increased from 160 children per 10,000 in 1998, to 240 per 10,000 in 2003.

Tom Woodward’s daughter Julie hung herself after being prescribed the antidepressant, Zoloft, off-label. He is angry at the Bush administration and the FDA for failing to protect the public against drug companies who hide studies that show drugs are dangerous when given to children.

“It is clear that the FDA is a political entity and its leadership has protected the economic interests of the drug industry,” he says.

According to Mr Woodward, officials in leadership positions have strong ties to the industry. “FDA’s chief counsel Daniel Troy has spent his career defending the drug industry,” he noted, “if a study does not favor a drug, the public never hears about it.”

“Under the Bush administration,” Mr Woodward said, “the FDA has placed the interests of the drug industry over protecting the American public.”

He points out that 86% of the millions of dollars in campaign contributions by drug companies went to Bush and Republican candidates and he wants to know, “what did Pfizer, Eli Lilly, and GlaxoSmithKline Beecham buy?”

A recent study reveals that even when the FDA does add a black box warning to a label, the highest form of drug safety alert available, doctors will continue to prescribe the drug.

The February 14, 2006 Archives of Internal Medicine featured a report on a study where researchers reviewed the records of 324,548 patients seen at several Boston area medical facilities between January 1, 2002 and December 31, 2002 and found that 33,778 patients were prescribed a drug that had a black box label, and 2,354 of those prescriptions were written contrary to the guidance set forth in black box warning.

The study found that in about 1,000 cases, patients were taking one drug at the same time as another when the warning said that taking the 2 drugs together should be avoided, and in about 90% of the cases, a drug was prescribed to treat a condition for which the drug was not approved.

According to Death by Medicine, each year approximately 2.2 million US hospital patients experience adverse drug reactions to prescribed medications and experts say many are caused by prescribing drugs for uses not approved.

The dangerous off-label prescribing practices have come under scrutiny in recent years because so many of the drugs are covered by government health care programs, and lawmakers charged with oversight of programs like Medicaid and Medicare became suspicious about the skyrocketing prescription drug costs.

In some of the largest cases involving Medicaid and Medicare fraud, former industry employees came forward with information about marketing schemes and filed lawsuits under the False Claims Act.

The Washington DC based Taxpayors Against Fraud, is a non-profit organization dedicated to combating fraud against the federal government through the promotion and use of the qui tam provisions of the False Claims Act.

Qui tam is a mechanism that allows persons with evidence of fraud to bring suit on behalf of the government. TAF educates the public about the FCA and its qui tam provisions and provides assistance to whistleblowers and their attorneys and sometimes files amicus curiae briefs on important issues.

TAF also has a staff of lawyers and other professionals who are available to assist anyone interested in the FCA and publishes the False Claims Act and Qui Tam Quarterly Review.

Whistleblower lawsuits are proving to be highly effective in exposing fraud. Of the 10 top FCA Medicaid fraud recoveries to date, the top 5 are whistleblower cases against drug companies.

According to TAF, during FY 2004, between October 1, 2003 and September 30, 2004, the US Department of Justice settled 3 whistleblower cases against drug companies for a total of over $800 million, raising the total recoveries in such cases by nearly 50% to $2.46 billion.

Two of the settlements involved both criminal fines and civil penalties. The recoveries included $290 million in criminal fines, $275 million in civil penalties and damages to the federal government, and nearly $235 million to state governments. All three settlements involved allegations of fraud against Medicaid.

Two of the cases began as lawsuits filed under the FCA by whistleblowers and the third began as a case under the Texas Medicaid Fraud Prevention Act.

The defendant in one case was the nation’s largest drug maker, Pfizer, with annual sales of $30 billion. The conduct at issue concerned a Pfizer subsidiary, the Parke-Davis Division of Warner-Lambert, acquired by Pfizer in 2000.

Drug maker Schering-Plough was the defendant in the other 2 cases.

Government recoveries from Pfizer totaled $430 million, and the two Schering settlements were $345 million and $27 million.

This is the second FCA whistleblower settlement entered into by Pfizer, and the second largest drug maker settlement ever when measured by the combined civil recovery of $430 million and the criminal fine of $240 million.

The Pfizer case broke new legal ground by recovering losses to Medicaid resulting from the illegal off-label promotion of a drug for uses other than those approved as safe and effective.

At the time of the settlement in May 2004, Pfizer’s drug, Neurontin, ranked 9th among all drugs sold in the US, with annual sales of $2.7 billion, according to IMS Health, “Leading 20 Products by U.S. Sales, Moving Annual Total, June 2004,” [imshealth.com].

The whistleblower, David Franklin, a former medical liaison for Parke-Davis, who filed the FCA lawsuit, received a $24.6 million settlement, when Warner-Lambert agreed to plead guilty to two felonies to settle charges that it fraudulently promoted Neurontin for a wide variety of unapproved uses.

Among the tactics the DOJ found the company using to achieve its goal of increasing off-label use of Neurontin were the following:

1. Encouraging sales reps to provide one-on-one sales pitches, or “details,” to physicians about off-label uses of Neurontin;

2. Utilizing medical liaisons, who represented themselves, often falsely, as neutral scientific experts on Neurontin, to promote off-label uses, working in tandem with the sales reps to directly sell Neurontin to physicians for off-label uses;

3. Paying doctors to allow a sales reps to see patients with the doctor and to participate in discussing the treatment plan;

4. Paying physicians, through both direct payments, and trips, hotel rooms, dinners and other benefits, to attend meetings termed “consultant” or “advisory” meetings or “speaker bureau trainings” in which doctors listened to presentations about off-label uses;

5. Implementing frequent teleconferences in which doctors were paid to speak about Neurontin on off-label topics to other doctors; and

6. Sponsoring independent “medical education” events on off-label uses where there was actually extensive input from the company on topics, speakers, content, and participants.

“Neurontin was marketed for four broad categories of unapproved use: pain, psychiatric use, monotherapy and dosage,” the DOJ stated. In fact, the company promoted the drug for so many unapproved uses, the DOJ said, “some employees referred to the list of these uses as the “snake oil” list.”

In the settlement agreement, the company admitted that it aggressively marketed the drug by illicit means for unapproved uses including pain, bipolar disorder, migraines, and drug and alcohol withdrawal.

The prosecutors described the harm that resulted from the off-label scheme as:

1. health care reimbursement programs such as Medicaid paid more in reimbursement;

2. consumers paid for ineffective, experimental use and may have been improperly medicated;

3. improper medication could have resulted where Neurontin was not as effective as another approved drug; and

4. unnecessary exposure of patients to adverse side effects of Neurontin.

The prosecutors said Warner-Lambert turned Neurontin into a blockbuster drug with promotional tactics like paying doctors “honoraria” to listen to sales pitches on the off-label use of the drug and by treating physicians to luxury trips to Florida, Hawaii, and Atlanta for the 1996 Olympics.

According to court documents filed in the case, doctors were paid honoraria to listen to presentations that took place at: “Bus to Yankee Stadium,” “World Yacht Cruise” and “Braves Stadium.”

On one weekend in April 1996, the DOJ discovered that Warner-Lambert had arranged 2 weekend “consultant” meetings, one at the Jupiter Beach Resort in Palm Beach, Florida, and the other at the Ritz-Carlton in Aspen, Colorado. Both were 3 day affairs, for which each attendee received a $250 cash payment, plus airfare, and all other expenses paid at the resort, and the doctors who acted as faculty were also paid between $1,500 and $2,000.

According to the DOJ, the total cost for the Jupiter Beach weekend was approximately $361,000 for about 100 doctors, meaning the price per doctor was about $3,000, and the cost of the Aspen weekend ran about the same.

Documents showed that both meetings included presentations on off-label topics such as “Neurontin: Use as Monotherapy,” and “Reduction of Pain Symptoms During Treatment with Gabapentin,” that were designed to present information to the attendees, rather than to receive information from consultants.

One advisory board was treated to an extravaganza at the 1996 summer Olympics in Atlanta, Georgia. Along with free Olympics tickets valued at $650 each, the company staged an Epilepsy Advisory Meeting, at the Chateau Elan Winery and Resort, in Atlanta.

The brochure for the event describes the resort as: “Chateau Elan has made a name for itself as a fine winery. It is now earning a reputation as a one-of-a-kind resort… Here, you’ll enjoy all the comforts and amenities you’d expect of a fine resort, mellowed by the warm ambiance of a French country inn.”

“During your meeting breaks,” the brochure says, “you will have the opportunity to play a round at one of three accessible golf courses, swim, play tennis, explore the Georgia hill country by foot or by horseback, or escape to Chateau’s European style spa for a pampering body treatment….”

For this event, records show the company paid all expenses for 18 advisers and their spouses, and each adviser was given $750 in cash for spending. In planning the Olympics advisory board meeting, a company document obtained by the DOJ, referred to the cost of the event as a “$3 million investment.”

Another example of the lavish meetings doctors attended for free, was the Western Advisory Board Meeting, held at the Grand Wailea Resort, Hotel & Spa in Maui, Hawaii in April 2000.

Only one of the attendees resided in Hawaii and the company paid for all of the others to fly to Hawaii for a two night stay at the resort to attend only 3 hours of meetings, all on off-label uses of Neurontin, according to the DOJ.

In planning this meeting, the company targeted doctors whose uses for Neurontin were only off-label and “evidence shows this event was promotional, not an independent, scientific meeting,” according to the DOJ’s sentencing memorandum.

The DOJ said Parke-Davis held hundreds of meetings where doctors were paid to attend, and paid even more to speak, and that Parke-Davis was especially interested in two types of physicians: (1) those who prescribed large amounts of anti-convulsants; and (2) those who had a prominent reputation.

These doctors were often referred to as the “movers and shakers” or “thought leaders” because of their influence, and were recruited as spokespersons on behalf of Neurontin.

Parke-Davis paid key “thought leaders” who could be counted on to deliver a strongly favorable message on off-label use. At least 20 of these doctors, the DOJ said, were paid more than $50,000 over time for speaking on the company’s behalf. In fact, some received in excess of $250,000.

Corporate documents show, the DOJ says, that the company focused its attention on recruiting doctors from major teaching hospitals to serve as “Neurontin champions.”

For example, documents show that Dr Steven Schachter, a professor at Harvard Medical School and a physician at Beth Israel Deaconess Medical Center in Boston received $71,477 between May 1994 and September 1997, and a Dr B.J. Wilder, a former professor of neurology at the University of Florida, was paid more than $300,000 for speeches given between 1994 and 1997. Six other doctors, including some from top medical schools, the DOJ said, received more than $100, 000 each.

The most common forums for speakers were consultant and advisory board meetings, where doctors were gathered to listen to a presentation. Parke-Davis justified holding these meetings, because it entered into pro forma consultant agreements with the physician attendees and doctors were paid anywhere from $250-$2,500 to serve as consultants or advisers.

In one 6-month period alone, the DOJ said, Park-Davis held over 50 meetings and despite being called “consultant” meetings, the actual objective was to provide off-label information to the doctors rather than to receive information from the consultants.

During its investigation, the DOJ discovered that doctors were misled into believing that educational programs they attended were independent programs when they were actually led by the drug maker. For example, prosecutors found a Ward-Lambert relationship with a company known as Physicians World where Warner-Lambert employees transferred to Physicians World to run the company’s speakers bureau.

At the same time, a division of Physicians World, known as Professional Post-Graduate Services, purported to be an independent education provider for a program on anticonvulsants for pain, when in fact, Ward-Lambert staff planned and developed the program and thousands of US doctors took the classes.

This program was provided to thousands of doctors all around the country and in each instance, the materials stated that they were created in compliance with ACCME guidelines, which prohibited content control by Parke-Davis as a condition of accreditation, and required disclosure of all financial affiliations.

The materials did not disclose the relationship between Physicians World and Parke-Davis, and did not disclose the financial links between Parke-Davis and each of the faculty members, all of whom were paid consultants, the DOJ said.

For instance, one physician was a regular Neurontin speaker who had received payments of more than $10,000 and yet by the listing of each faculty member, there was an asterisk indicating “no significant financial or other affiliation reported.”

“This evidence,” the US attorney said, “demonstrates that Parke-Davis knew that these events were unlawful promotional activities.”

Another method of promoting face-to-face was the preceptorship, or “shadowing.” This involved paying a doctor to allow a sales rep to follow the doctor through the course of a day seeing patients. In one example, a sales rep did a preceptorship with a neurologist and after they saw a teenage patient, the doctor and the sales rep discussed treatment options.

The sales rep advised the doctor to increase the Neurontin dose and at the same time, taper the patient off other epilepsy medication to reduce side effects, thus resulting in Neurontin being used for monotherapy. According to the sales rep, as recorded in a voice mail sent in to the company obtained by the DOJ: “I really felt I made a difference. I saw the actual prescription generated in front of me… and I certainly felt that by me being there, I had some influence on that medical decision.”

Another patient seen was a 65 year old veteran who suffered neuralgia with pain in his limbs. The patient developed blurred vision while on Neurontin; and the sales rep told the doctor that such side effects are mild and transient and so the doctor kept the patient on the drug. In the sales rep’s own words: “I felt like I influenced that particular situation. So again, another prescription was generated for us. Overall, the day went, you know, very well. And we had the immediate impact of two prescriptions written.”

The DOJ said the drug maker decided not to seek an expanded use for Neurontin with the FDA because it would have required solid proof from clinical trials so instead, the company boosted sales through promotional strategies, even for conditions where studies had indicated that Neurontin was not effective.

In his sentencing Memorandum the US Attorney noted: “One of the psychiatric uses for which Neurontin was promoted… bipolar disorder, was particularly troubling because the Company had very weak evidence of Neurontin’s efficacy in treating this condition.”

“Indeed,” the prosecutor wrote, “in one study… the placebo was as effective or more effective than was Neurontin.”

Moreover, the DOJ found the company paid no attention even when the FDA did refuse to approve an additional use. For instance, Parke-Davis sought approval for use as a monotherapy on September 16, 1996, but because one of 2 clinical trials submitted with the application showed no demonstrable monotherapy efficacy, on August 26, 1997, the FDA rejected the application.

Nonetheless, the DOJ found that Parke-Davis had actively promoted the drug for monotherapy before it applied for approval, and after the FDA rejected its application right through at least 2000, when slides, lecture summaries and audiotapes obtained by the DOJ demonstrate that Parke-Davis continued to promote Neurontin for monotherapy without ever mentioning the fact that the FDA had rejected its application.

Documented examples listed by the DOJ, of statements made after the FDA’s non-approval include a marketing event in 1998, where Parke-Davis went so far as to state that Neurontin was “now approved as monotherapy for seizures.”

In his whistleblower lawsuit, Mr Franklin explained how Warner-Lambert had hired two marketing firms to write favorable articles about the unapproved uses of Neurontin and to find doctors willing to sign their names as the authors. The marketing firms, he said, were paid $12,000 for the articles and the doctors were paid $1,000 for signing off as authors.

The off-label scheme proved to be highly successful. By government estimates, citing company documents and independent market research, by 2002 94% of Neurontin’s sales were for off-label use, up from 40% in 1995.

At the time of the settlement in 2004, Vermont Attorney General, William Sorrell, noted that a 30-day supply of Neurontin at a common dose sold for $205.

Under the terms of the settlement agreement, Pfizer agreed to:

1. plead guilty to inadequately labeling of Neurontin and to introducing Neurontin into interstate commerce for unapproved purposes, which, by virtue of its prior violation of the Food, Drug & Cosmetic Act, constitute felony violations of the Act, and to pay a $240,000,000 criminal fine;

2. settle its False Claims Act and other civil liabilities and to pay the Government $83,600,000, plus interest, in civil damages for losses suffered by the federally funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

3. settle its civil liabilities to the 50 states and the District of Columbia in an amount of $68,400,000, plus interest, in civil damages for losses suffered by the state-funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

4. settle its civil liabilities to the Consumer Protection divisions of 50 states and the District of Columbia state attorney general’s offices in an amount of $38,000,000, plus interest, in civil damages for losses suffered by consumers and to fund a remediation program designed to offset the impact of the improper marketing of Neurontin; and

5. comply with the terms of an amendment to the corporate compliance program of its parent, Pfizer, which, among other things, prescribes off-label marketing and requires training of employees and audits of its marketing practices.

At the time of the settlement, Pfizer issued a statement that said the illegal practices took place before Pfizer acquired Warner-Lambert in 2000. However, even if true, sales figures reveal that Pfizer was still reaping the benefits of the scheme at the time of the settlement.

For instance, on August 19, 2004, USA Today noted that: “Pfizer’s confession that the success of one of its top drugs was built partly on fraud may have been humbling, but it isn’t hurting the bottom line. Neurontin sales last quarter rose 32% from a year ago, and 2004 sales should pass last year’s $2.7 billion.”

“With few exceptions,” USA said, “state Medicaid programs pay for Neurontin just as before and so do major insurers.”

Pfizer’s denials also rang hollow at the time due to the fact that the company’s regulatory filings showed the DOJ was also scrutinizing its off-label marketing of the Genotropin growth hormone and a federal grand jury in Maryland was taking testimony from former Pfizer employees about the diabetes drug, Rezulin, that was pulled off the market in 2000 after it was linked to over 60 liver-related deaths.

But as far as fearing the FDA, the drug companies had no fear and apparently for good reason. documents unearthed in litigation reveal that the FDA was well aware of the company’s off-label marketing scheme eight years before the settlement. In July, 1996, FDA official, Lesley Frank, wrote to Parke-Davis and said in part:

“Parke-Davis may be promoting Neurontin for ‘off-label’ uses… in printed promotional materials, in detail or sales presentations to physicians, and through the use of company-solicited physician participation in a series of teleconferences.

“These promotions of Neurontin for off-label uses included, but were not limited to, its use in chronic pain, bipolar disorders, and other psychiatric conditions. As you are aware, Neurontin’s only approved indication was for adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy.”

Documents show that after 11 months, Parke-Davis responded and denied all allegations and the FDA simply accepted the company’s denial and the issue was dropped.

As part of the settlement with the DOJ, Warner-Lambert pleaded guilty only to conduct that occurred before August 21, 1996, even though illegal conduct is documented as occurring much later than 1996.

This part of the agreement made it possible for Pfizer to continue to participate in government health care programs despite an August 21, 1996, health care fraud law that would have led to its exclusion.

In addition to financial fraud, the company pleaded guilty to criminal misbranding of the drug in promotional and advertising material claiming that “the drug is safe and effective for uses which have not been approved by the FDA.”

Pfizer’s settlement with the DOJ did not cover damages for any patients who may have been harmed by Neurontin and those patients are entitled to file personal injury lawsuits.

Pfizer is currently engaged in multi-district litigation (MDL). On October 26, 2004, the Judicial Panel on Multidistrict Litigation consolidated nearly all Neurontin off-label cases in the US District Court for the District of Massachusetts.

The JPML is a panel of seven federal judges chosen by the Chief Justice of the US Supreme Court that decides on the appropriateness of establishing an MDL, and where the MDL should reside. The MDL brings together lawsuits with common claims to determine pretrial matters.

The MDL primarily involves cases of consumers who purchased Neurontin for off-label uses that Pfizer knew showed no efficacy but more lawsuits have been filed on behalf of persons who suffered adverse effects when Neurontin was prescribed for off-label uses. The first Neurontin trial is expected to take place later this year or early 2007.

In 2004, the New York law firm of Finkelstein & Partners filed several lawsuits and announced plans to file many more. At the time, the firm’s senior partner, Andrew Finkelstein, said he had gathered the names of 160 people who committed suicide and 2000 more who attempted suicide while taking Neurontin.

In addition to handling lawsuits, for more than 2 years Mr Finkelstein’s law firm has been warning the FDA about patients committing suicide while taking Neurontin and asked the FDA numerous times to add a black box warning to Neurontin’s label about the risk of suicide in patients taking the drug. As of October 2005, Mr Finkelstein has been contacted by the relatives of 425 people who committed suicide while on Neurontin.

After a year of inaction by the FDA, on March 21, 2005, Mr Finkelstein wrote a letter to the FDA’s Dr Russell Katz and said in part: “Enclosed you will find two hundred fifty eight MedWatch forms… Each represents a suicide of an American who was on Neurontin when he or she took his or her own life.”

Mr Franelstein told Dr Katz the “complete inaction by the FDA to warn an unknowing population that was relying upon the FDA to require warnings for potential adverse events from off-label usage, is deplorable.”

“Since our conversation of March 31, 2004,” he wrote, “my firm has learned of seventy four additional suicides that occurred after that date.”

“Many of these suicides likely could have been prevented,” he said, “had both the treating physician and unsuspecting families been armed with full knowledge of the risks of suicide that was known to both the FDA and the manufacturer.”

Neurontin was recommended for approval by the Neuropharmacolgical Drug Products Division of the FDA in 1992, and according to Mr Finkelstein, at that time, Mr Katz oversaw the FDA’s analysis of the clinical data supplied by the sponsor seeking approval to sell Neurontin.

Mr Finkelstein obtained the FDA’s 1992 analysis of the New Drug Application for Neurontin, and in reviewing the data, he told Dr Katz he found “shocking information.”

“During your evaluation of serious adverse events that occurred during original clinical trials,” he advised Dr Katz in the letter, “the risk of Neurontin causing suicide was both known and a major concern.”

The FDA reviewer from your Division, Mr Finkelstein pointed out, “specifically stated in December, 1992:

“Serious adverse events may limit the drug’s widespread usefulness. Depression, while it may not be an infrequent occurrence in the epileptic population, may become worse and require intervention or lead to suicide, as it has resulted in some suicidal attempts during
clinical trials.

“In fact, during the clinical trials… Neurontin was attributable to four people actually attempting suicide, two more having depression with suicidal ideations and twenty-two participants reporting depression so severe it required pharmacologic intervention.

“Additionally,” he said, “nineteen of the seventy-eight participants who reported depression during the clinical trials had no prior history of depression.”

“Clearly,” Mr Finkelstein wrote, “the FDA did not approve this drug with any expectation of use beyond the approved indication.”

“Even though the FDA knew Neurontin caused depression that may lead to suicide and that Neurontin’s effects were never fully tested on people who suffered from chronic pain, bipolar disorder or other psychiatric conditions,” he told Dr Katz, “the FDA acted with no urgency.”

Mr Finkelstein reminded Dr Katz of the company’s 2004 conviction for fraud in the DOJ case and said: “The complicity by the FDA in Parke-Davis’s scheme to defraud physicians and consumers is more egregious than the underlying fraud itself.”

“The governmental body charged with the responsibility of protecting the health and safety of Americans has done absolutely nothing to prevent entirely preventable deaths,” he continued. “Such complicity borders on criminality,” he added.

On October 14, 2005, Mr Finkelstein wrote another letter to Dr Katz and summarized the efforts by his law firm to get the FDA to warn people about the risk of suicide over 2 years and began by saying: “Due to the continued public danger facing a substantial class of prescription drug users, I am compelled to write to you regarding the FDA’s ineffective oversight related to appropriate warnings for Neurontin.”

“On March 31, 2004,” he reminded Mr Katz, “you were advised of thousands of serious psychiatric adverse events that occurred while Americans were taking Neurontin.”

“At that time,” he said, “the FDA recognized a potential imminent health crisis existed, yet nothing was done to require enhanced warning labels.”

“Due to the FDA’s inaction,” Mr Finkelstein continued, “my firm filed a citizen’s petition on May 17, 2004 with the hope that the FDA would investigate the potential for Neurontin contributing to self-injurious behavior.”

In addition to the black box warning, the Petition asked that a Dear Doctor letter be sent to health care providers cautioning them to be on alert for increased depression in patients taking Neurontin.

“The FDA took six (6) months to respond,” Mr Finkelstein told Dr Katz, “and stated no decision had been reached and more time was needed to investigate.”

“All investigations, if any,” he wrote, “have been couched in secrecy and not open to public scrutiny while the same serious health crisis continues.”

“Regrettably,” the letter concluded, “this is an example of why the American people have lost faith in the FDA’s ability to protect them from unsafe drugs.”

“While your real motivations are not known at this time,” he advised, “it is clear your interest is not in discovering the truth or protecting the health and safety of the American people.”

Author, Dr Marcia Angell, also recognizes the massive influence that drug companies exert over the FDA, Congress, and doctors, and how this influence is harming Americans.

After she resigned as interim editor-in-chief of the New England Journal of Medicine in 2000, Dr Angell decided to write a book about the biases in clinical trials but in doing her research, says she discovered that “all roads led back to drug companies.”

Her book, “The Truth about Drug Companies: How They Deceive Us and What to Do About It,” provides an indepth account of the entanglements between Big Pharma and every area of the health care field including government agencies, doctors, medical journals, Congress, and universities, as well as how these relationships harm the public.

During an August 18, 2004 interview with Business Week Online, Dr Angell told reporter Amy Tsao, that she saves her harshest criticism for her fellow physicians and the medical profession as a whole. “After all,” she said, “the industry is in business to make money, but that isn’t what doctors and medical schools should be doing.”

“They don’t have to be in bed with the drug companies,” she said. “But they are.”

Dr Angell explained how drug companies finance most of the continuing education seminars for doctors, as well as meetings of professional societies, and how they lavish all kinds of gifts on doctors including dinners in fancy restaurants and trips to exotic resorts.

“And they provide speakers and meals for interns and residents in teaching hospitals,” she told Business Week.

All of which, she says, adds to the high cost of prescription drugs. “The profession should acknowledge that this is all a form of marketing,” she said, “which adds to the prices of prescription drugs.”

“Doctors should take responsibility for their own education and buy their own meals,” Dr Angell said.

The most perverse examples of off-label marketing involve drugging children. In 2001, Dr Stefan Kruszewski, a Harvard-trained psychiatrist working for the Pennsylvania Department of Public Welfare, began investigating the widespread off-label use of psychotropic drugs and found cases of what he calls “horrendous polypharmacy.”

The first disturbing pattern he noticed was that an overwhelming number of patients were being prescribed Neurontin to treat conditions like anxiety, depression, psychosis and impotence. “The FDA had not approved using that drug for mental illnesses,” he noted.

Dr Kruszewski found patients on as many as 5 medications at the same time, something he says is “hard to justify.”

One of the most disturbing cases he found was a mentally retarded 15-year-old girl who was supposedly being treated for defiance and sexual promiscuity.

Dr Kruszewski discovered that the girl was on 11 different drugs, including five anti-psychotics, even though she had no diagnosis of a psychiatric disorder. “She was so overmedicated,” he said, “that she had trouble getting out of bed or standing up by herself.”

“Although physicians can choose to prescribe virtually any medication for any condition,” he explains, “the promotion of Neurontin remains the subject of intense scrutiny since Pfizer’s off-label promotion was previously the subject of civil and criminal penalties by the US Department of Justice.”

“In my opinion as a clinical and academic psychiatrist,” Dr Kruszewski says, “Neurontin’s link to severe emotional and cognitive disturbances, including mania, depression, suicide and memory loss, continues to be the most egregious aspect of Neurontin’s promotion.”

“It causes suffering, morbidity and death,” he noted, “problems that Pfizer and the current generic makers of Neurontin have failed to make known to consumers and potential victims,” he said.

Attorney, Zena Crenshaw, Executive Director for National Judicial Conduct and Disability Law Project, agrees that off-label prescribing is a major problem and says any drug manufacturer even suspected of such “market expansion” should be called to the carpet.

“The idea of salesmen hyping drugs to doctors,” she says, “for conditions beyond those for which the products were approved, is unnerving.”

“Considering that even dire prescription drug warnings probably reflect a minimum level of adequate care,” she warns, “prescribing drugs off-label should seem universally hazardous.”

When Dr Kruszewski warned his superiors that off-label use of the drugs was not only harmful to patients but could also expose the state to liability from lawsuits by injured patients, he was told “it’s none of your business.”

When Dr Kruszewski continued to voice his concerns he was told to quit digging up dirt, and when he refused to let go, he was fired. He has since filed a whistleblower lawsuit against state officials and 6 drug companies including Pfizer, alleging, among other things, that the defendants: “through the use of political friendships, money and other emoluments, effectively achieved a level of influence with Pennsylvania’s state government that allowed them to abuse state finances and state citizens with impunity.”

The Government Accountability Project (GAP) is a nonprofit public interest group that promotes government and corporate accountability by advancing occupational free speech, defending whistleblowers, and empowering citizen activists.

The GAP is assisting Dr Kruszewski with his lawsuit against the drug giants. Mark Cohen, an attorney with the GAP, describes whistleblowers like Dr Kruszewski as “regular people who have been pushed beyond the limits their consciences can bear.”

“They feel a moral duty to set the situation right,” he says.

“They can no longer “go along to get along” in the face of wrongdoing,” he explains. “And they can’t simply opt out – take another job and keep their lips sealed – and ignore the wrongdoing,” he says.

“But if “right” and “wrong” mean anything,” Mr Cohen says, “they feel they don’t really have a choice but to blow the whistle.”

“Of course, they do so at great personal risk,” he says. “Speaking up puts their current job in jeopardy and it threatens to brand them as trouble-makers with other employers.”

In fact, people who do expose the highly profitable Medicaid fraud or off-label practices often find themselves fired, like Dr Kruszewski. However, the False Claims Act now provides a cause of action for whistleblowers with remedies that include reinstatement to their job, 3 times the wages lost, compensatory damages, and attorney’s fees.

Filed under: 2006, MEDICAID, MEDICARE, Neurontin, Pfizer, suicide, TMAP, whistleblower

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