The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Lilly Faces Mounting Legal Battles Over Zyprexa – Part I

Evelyn Pringle November 7, 2007

Since August 2006, as part of an on-going, multistate investigative effort by approximately 30 states, Eli Lilly has received civil investigative demands or subpoenas seeking a broad range of documents relating to the company’s marketing and promotion of the antipsychotic drug
Zyprexa, and more states are expected to join the effort.

In addition, a total of ten states are now suing Lilly for Medicaid fraud to recover the cost of Zyprexa purchases for persons covered by the program, along with the past and future costs of treating Zyprexa-related illnesses. Alaska, Arkansas, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, Utah and West Virginia have filed cases thus far.

Zyprexa belongs to a new generation of antipsychotic drugs known as “atypicals” which arrived on the US market in 1994, beginning with Risperdal, marketed by Johnson and Johnson subsidiary Janssen. Other drugs in this class include Seroquel, sold by AstraZeneca; Geodon, by Pfizer; Abilify, from Bristol-Myers Squibb and Clozaril, marketed by Novartis.

For the first four years that Zyprexa was on the market in the US, it was only approved to treat adults with schizophrenia, and it was not until 2000 that the FDA approved the drug for adults in the manic phase of bipolar disorder.

However, in a matter of a few short years, Lilly turned Zyprexa into its best-selling product, despite the drug’s extremely limited approved uses, by influencing doctors to prescribe the drug off-label.

In addition to prescribing a drug for unapproved uses, off-label can mean treating an approved condition for a longer duration of time, or prescribing a drug in combination with other drugs, or at a different dosage, or to a different patient population such children or the elderly, other than those specified on the FDA-approved label.

According to Lilly’s SEC filings, the Office of the US Attorney for the Eastern District of Pennsylvania has also advised Lilly that it has commenced a civil investigation related to the company’s marketing and promotion of Zyprexa, and a “number of State Medicaid Fraud Control Units are coordinating with the EDPA in its investigation of any Medicaid-related claims relating to Lilly’s marketing and promotion of Zyprexa.”

Lilly has also received subpoenas from the Office of the Attorney General of the State of Illinois, and the Florida Office of the Attorney General, Medicaid Fraud Control Unit, asking for documents relating to sales, marketing and promotion of Zyprexa.

Lilly’s SEC filings also report that the company has received requests for information related to the company’s marketing and promotion of Zyprexa from the offices of Representative Henry Waxman, Chairman of the House Committee on Oversight and Government Reform, and Senator Charles Grassley, the ranking Republican on the Senate Finance Committee.

Collectively, the Medicaid fraud lawsuits allege that Lilly illegally influenced doctors to prescribe Zyprexa off-label to patients, including children, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, Alzheimer’s, Tourette’s syndrome, dementia and other unapproved indications.

The lawsuits also allege that Lilly concealed the adverse effects associated with Zyprexa, including drastic weight gain, high blood sugar levels, diabetes and pancreatitis.

Other serious adverse effects known to be associated with Zyprexa include Parkinson-like symptoms, akathisia, tardive dyskinesia, dystonia, hypotension, constipation, tachycardia, seizures, liver abnormalities, white blood cell disorders and death.

The Mississippi lawsuit alleges that about 10% of Zyprexa patients have developed diabetes, some of whom are children, even though Zyprexa “has never been approved for, nor found to be effective, in the treatment of children.”

An estimated 1,500 Utah Medicaid patients who took Zyprexa have developed diabetes, according to the lawsuit filed on May 29, 2007, by state attorney general David Stallard.

Utah is seeking damages including $5,000-$10,000 for each prescription that was “not medically necessary.”

Lilly recently attempted to get the Utah case dismissed, in part by arguing that the allegations of off-label promotion and failure to warn were preempted by FDA regulations under a new rule put in place by the Bush Administration, largely viewed as a gift to the pharmaceutical industry.

In 2006, the FDA published a preamble to new prescription drug labeling rules in which it asserted that its approval of the labeling would prevent the filing of lawsuits in state courts premised on a theory that a drug company should have provided additional warnings on a drug’s label.

However, the Utah court ruled against Lilly on this issue and stated, in part: “In fields traditionally occupied by the states, such as health and safety regulation, there is a strong presumption against federal preemption,” and Lilly “has not overcome this strong presumption.”

Pennsylvania alleges that the state spent millions of dollars “for non-medically accepted indications and non-medically necessary uses of Zyprexa,” as well as “significant sums of money for the care and treatment” of patients injured by the drug.

Montana’s complaint charges that, “Lilly management participated, encouraged and authorized the unlawful payment of illegal kickbacks to physicians in order to continue generating sales of Zyprexa.”

The Montana lawsuit is asking for reimbursement on behalf of all citizens who purchased Zyprexa, and not only patients covered by public health care programs, because under the law in that state, the attorney general can request treble damages and attorneys’ fees on behalf of all consumers.

There are also several RICO class actions filed against Lilly on behalf of union insurance plans, pension funds, and other private health insurers, which accuse Lilly of violating racketeering laws and allege the drug maker engaged in illegal marketing schemes to promote the sale of Zyprexa for off-label uses and seek to recover the cost of purchasing the drug, as well as treble damages, punitive damages and attorneys’ fees.

On June 28, 2007, Lilly lost a motion for a summary judgment dismissal of the RICO claims, based on the preemption argument, when District Court Judge Jack Weinstein for the Eastern District of New York ruled against the company, In re Zyprexa Products Liability Litigation, 2007 WL 1851161.

In a written ruling rejecting Lilly’s argument that state law failure-to-warn claims are preempted, Judge Weinstein wrote that “the regulation of public health is an area traditionally occupied by the states, supporting a presumption against preemption.”

“Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs’ bar,” he stated, “the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs.”

The Judge also noted that Congress had not stated an intent to preempt these claims. “The FDA cannot be allowed to usher in such a sweeping change in substantive law through the back door,” he wrote.

The Medicaid fraud lawsuits allege that many children have been turned into customers for the off-label prescribing of Zyprexa. A recent October 7, 2007, report from the Florida Agency for Health Care Administration entitled, “The Use of Antipsychotic Medications with Children,” found that pediatric use of antipsychotics increased in the late 1990′s and early 2000′s, largely due to the arrival of the atypicals on the market.

The report noted that one study documented a 75% increase with commercially insured children aged 0 to 17 from 1997 to 2001, and another study of the managed care population from 1996 to 2001 found a 127% increase among children aged 0 to 18.

The study also reported that antipsychotic use in the Medicaid populations was three to four times higher than commercial populations in the late 1990′s, and in one program in the Midwest, the rate of prescriptions grew 304% between 1996 and 2001.

The authors said the analysis showed that the drugs are being used to treat a broad spectrum of disorders, and some of the disorders, such as attention deficit hyperactivity disorder and major depression, “clearly do not call for antipsychotic treatment.”

In the 0 to 5 age group, the study found that more than 53% of the drugs were prescribed for ADHD, even though antipsychotic use with children under 6 “should be considered only in very rare circumstances.”

A report in the May 10, 2007, New York Times revealed some of the known adverse events that occurred in children who were prescribed antipychotics in 2006 alone. The FDA received reports of 29 children dying, and at least 165 other serious side effects in children, where an antipsychotic was listed as the primary suspect, according to the Times.

The FDA acknowledges that its reporting system only picks up between one and ten percent of the adverse events that take place, which means the number of deaths and injuries above must be multiplied many times over to obtain an accurate estimation of how many children have been harmed by the drugs.

Filed under: 2007, antipsychotics, Eli Lilly, Fraud, MEDICAID, Preemption, Zyprexa

Lilly Faces Mounting Legal Battles Over Zyprexa – Part II

Evelyn Pringle November 10, 2007

Several Zyprexa-related class actions have been filed against Eli Lilly on behalf of the company’s shareholders charging Lilly, and certain of its officers and directors, with violations of the Securities Exchange Act.

On April 2, 2007, the Schiffrin Barroway Topaz & Kessler law firm issued a press release to announce a class action filed on behalf of all purchasers of Lilly stock between March 28, 2002, and December 22, 2006, alleging that Lilly disseminated false and misleading statements regarding Zyprexa.

More specifically, it alleges that Lilly was aware of a “clear link” between Zyprexa and diabetes, failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur when reports of side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for Zyprexa based on “off-label” uses, in direct violation of Lilly’s own code of conduct.

The complaint further alleges that concealing the side effects and engaging in an illegal marketing campaign subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company’s overall financial condition and prospects.

According to the complaint, between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and between July 18, 2002, and May 7, 2004, Lilly’s stock value increased from $43.75 per share to $76.95.

But when public warnings were issued about the safety of Zyprexa, the lawsuit alleges, sales slowed and share prices dropped from $76.95 to $50.34 between May 7, 2004, and October 25, 2004, representing a loss of market capitalization of over $30 billion.

Another shareholder’s complaint claims that Lilly had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, “the Company adamantly refused to acknowledge any wrongdoing.”

Still another lawsuit alleges that Zyprexa does cause such side effects, and to a greater extent than its competitors, and the “revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements.”

A number of Zyprexa cases have been filed against Lilly in other countries as well.
In private litigation, almost all of the federal lawsuits are part of a Multi-District Litigation proceeding before Judge Jack Weinstein in the Federal District Court for the Eastern District of New York.

Since June 2005, Lilly has entered into out-of-court settlements with approximately 30,200 claimants in the US for about $1.2 billion, and there were still about 350 lawsuits covering about 540 claims pending at the time of the company’s August 7, 2007, SEC filing.

However, on June 29, 2007, Rob Waters and Margaret Cronin Fisk reported in Bloomberg News that Lilly “may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from US regulators.”

They report that Lilly was told in March that the FDA would delay the approval of Symbyax, which contains both Zyprexa and Prozac, for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the prescribing label. Symbyax was already approved for bipolar disorder.

In a letter obtained by Bloomberg, the FDA stated: “We are concerned that the proposed labeling is deficient with regard to information about weight gain and high levels of sugar and fat in the blood of patients who took the drug.”

“We do not feel that current labeling for either Symbyax or Zyprexa provides sufficient information on these risks,” the agency wrote.

According to Bloomberg, the FDA said Lilly’s proposed prescribing information for Symbyax failed to disclose that almost half of the patients who had high or borderline blood sugar levels when they started taking the drug ended up with levels high enough to be considered diabetic and that was over nine times the number of patients on placebos.

“We were troubled that this important information was not included in your proposed label,” the agency said.

“The FDA’s request,” Bloomberg points out, “may bolster plaintiffs’ suits against the Indianapolis company over side effects tied to Zyprexa,” attorneys told the reporters.

“When the FDA says something damning about the warnings of a drug, it’s admissible as evidence on the reasonableness of the manufacturer’s decisions,” said David Logan, dean of the Roger Williams University School of Law, in an interview with Bloomberg.

“It would likely carry some weight with juries,” he stated.

Experts say, in light of all the studies which have shown that the older cheaper antipsychotics work as well or better than atypicals for schizophrenia patients, it’s difficult to understand why Zyprexa is still being prescribed for those patients.

An October 2006 study in the Archives of General Psychiatry, funded by the British government and lead by Dr Peter Jones, a psychiatrist at the University of Cambridge, compared treatment outcomes for schizophrenia patients with the older antipsychotics with treatment results from the new atypicals and found the quality of life of patients was slightly better with the older drugs.

The study was conducted on behalf of Britain’s National Health Service to determine whether the increased cost of the new atypicals was justified and involved 227 patients who were assigned to two groups and evaluated by researchers who did not know which medication the patients were taking for over a year.

In the October 3, 2006, Washington Post, Dr Jones said a conservative interpretation of the data suggests that there is no difference, “so the notion you would pay 10 times as much would be difficult to justify.”

“Why were we so convinced?” he asked, referring to the widespread belief that the new drugs were worth the cost. “I think pharmaceutical companies did a great job in selling their products,” he said.

Experts are quick to point out that earlier studies in the US had produced the same results. In 2003, the Department of Veterans Affairs found there was no difference in compliance, symptoms or overall quality of life in patients treated with the older drug Haldol compared with Zyprexa, and a September 2005 government-funded study in the New England Journal reported that patients taking the older drug perphenazine did as well as patients on the new drugs and patients on atypicals experienced more side effects.

“The story of these newer antipsychotic drugs is a story that reveals an institutional gap,” according to Dr Robert Rosenheck, who was involved in both US studies, in the Post on October 3, 2006.

“It should not have needed 10 years to get three government studies,” he noted.

The fact is, Lilly promoted Zyprexa as being more effective than the older drugs with less side effects right from the start. On November 14, 1996, the FDA’s Division of Drug Marketing, Advertising and Communications sent a letter to Lilly addressing the company’s misrepresentations of the risks and benefits of Zyprexa in an October 2, 1996, promotional teleconference conducted by Dr Gary Tollefson, Vice President of Lilly Research Laboratories.

During the conference, the FDA said, Dr Tollefson made the false claim that Zyprexa did not cause the Parkinsons-like side effects observed in patients who received Haldol, and even though the FDA labeling for Zyprexa included weight gain as an adverse effect, during the conference Dr Tollefson claimed that it usually occurred in patients who were underweight to begin with, making it sound like weight gain was actually a benefit of the drug, according to the FDA letter.

In addition to the many serious health problems found to be associated with Zyprexa in recent years, experts say the suicide rate amongst Zyprexa patients is also high. According to an analysis of the FDA’s adverse event reports by Dr Gregory Warren, an independent researcher and statistician, since Zyprexa came on the market in 1996, there have been 532 suicide reports on the drug filed by health care professionals.

UK psychiatrist and professor Dr David Healy, one of the world’s leading authorities on pharmacology, says there has been a ten- to twenty-fold increase in the rate of suicide among patients diagnosed with schizophrenia since antipsychotics were first introduced.

All that said, apparently no amount of litigation will slow the off-label prescribing of Zyprexa. In 2006, sales were $4.3 billion, and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to the SEC filings.

Critics say going after the drug makers is not enough, that it’s time to sue the doctors who prescribe drugs off-label. Alaska human rights attorney Jim Gottstein says psychiatrists are seldom held legally responsible for their failure to adequately inform patients about the true efficacy and harms of the drugs they prescribe.

“This has likely lulled them into a false sense of security,” he notes, “because there are various factors at work which could loosen a tidal wave of legal cases against doctors who do not adequately inform their patients about the benefits and harms, including the efficacy of other approaches and of nontreatment.”

Filed under: 2007, antipsychotics, Eli Lilly, Fraud, MEDICAID, Zyprexa

World Experts Demand End to Child Drugging in the US – Part I

Evelyn Pringle October 25, 2007

On October 12, 2007, experts in the field of psychiatry and child development from all over the world arrived in Washington to attend the annual conference of the International Center for the Study of Psychiatry and Psychology. This year’s conference focused on one specific goal – to end the mass-prescribing of psychiatric drugs to children.

In addition to the seminars and presentations by psychiatric experts and academics, other presenters and speakers at the conference varied from patients and leaders of patient advocacy groups to social workers, nurses, educators, authors and lawmakers.

The conference included presentations on the serious health risks associated with the new generation of psychiatric drugs now commonly prescribed to children, including attention deficit medications, antidepressant drugs and atypical antipsychotics.

Much of the outrage expressed by speakers and attendees alike stemmed from the recommendation by the Bush Administration’s New Freedom Commission on Mental Health to conduct “universal” mental illness screening of all Americans from the age of “0″ on up to the oldest living citizen.

The main topics of debate included the recommendations by the NFC to screen public school children in all 50 states with a program called TeenScreen and the implementation in many states of programs modeled after TMAP (Texas Medication Algorithm Project), a treatment plan that mandates the use of the new expensive psychiatric drugs with all patients diagnosed with mental disorders who are covered by public health care programs such as Medicaid.

The new generation of antidepressant drugs include Prozac and Cymbalta by Eli Lilly; Paxil marketed by GlaxoSmithKline; Zoloft by Pfizer; Celexa and Lexapro from Forest Laboratories; Effexor by Wyeth, as well as generic versions sold by Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

The new generation of atypical antipsychotics include Zyprexa by Eli Lilly; Risperdal marketed by Janssen Pharmaceuticals, a subdivision of Johnson & Johnson; Abilify by Bristol-Myers Squibb; Clozaril sold by Novartis, and Geodon by Pfizer.

Many of the presentations at the conference focused on the pharmaceutical industry’s role in the invention of both TMAP and TeenScreen and the many financial ties between the drug makers, the Bush administration, a group of psychiatrists, and state policy makers largely credited with the creation and promotion of these two programs.

Minnesota Pediatrician Dr Karen Effrem produced a briefing booklet and CD entitled, “The Dangers of Universal Mental Health Screening,” which is available at the ICSPP web site at http://www.icspp.org/.

During her presentation, Dr Effrem explained the history of TMAP and TeenScreen, a 52-question computerized self-administered questionnaire that takes 10 minutes to complete and was developed by Columbia University Children’s Psychiatric Center.

“The New Freedom Commission, TMAP and TeenScreen,” Dr Effrem notes, “appear to be a blatant political/pharmaceutical company alliances that promote medication, and more precisely, more expensive antidepressants and antipsychotics, which are at best of questionable benefit and come with deadly side effects.”

During the portion on TeenSceen, Dr Effrem cited one study which found an 82% false-positive rate in students screened, meaning that if 100 students were tested, 82 were wrongly flagged as having some mental disorder. “TeenScreen’s extremely high false-positive rate makes the test virtually useless as a diagnostic instrument,” she stated.

According to Dr Effrem, it is “difficult, if not impossible” to diagnose young children accurately, due to very rapid developmental changes. “Often, adult signs and symptoms of mental disorders in adults are characteristics of normal development in children and adolescents,” she explains.

Since the arrival of selective serotonin reuptake inhibitors antidepressants (SSRI’s) and atypical antipsychotics on the market, countless studies have shown the so-called “wonder drugs” to be ineffective and harmful to children. But for years, drug companies have manipulated data, suppressed negative clinical trials and published only the studies that showed positive results.

The truth is that the mass drugging of the entire population in the US with SSRI’s has accomplished nothing when it comes to reducing suicidality. According to a June 2005 study, primarily funded by the National Institute of Mental Health, in the Journal of the American Medical Association, although people who were likely to attempt suicide were far more likely to be treated with antidepressants in 2001-2003, the rates for suicide attempts, gestures and ideation remained basically unchanged for over a decade.

To reach their conclusions, the researchers analyzed a survey of close to 10,000 adults and compared it to a similar survey conduced 10 years earlier for the years 1990-1992.

The prescribing rates for psychiatric drugs increased every year during that time period. On January 13, 2005, WebMD reported a government study that reviewed the patterns of treatment from the mid-1990′s to 2001, and found more Americans than ever were being treated for depression, substance abuse and mental disorders but that the treatment was most often limited to drugs alone.

The cost of mental health drugs rose 20% each year, and according to study, about 80% of the increase could be explained by the increased prescribing of antidepressants and atypical antipsychotics.

A “Myth and Fact Sheet” presented at the conference reports that, in 2003, more money was spent on psychiatric drugs for children than on antibiotics and asthma medications.

By tugging at the heartstrings of parents in claiming TeenScreen is a suicide prevention tool, the drug profiteers have managed to set up the bogus screening program in towns and cities all across America, and the promoters never seem to tire of using the line that suicide is the third leading cause of death in teens and adolescents in the US. However, experts explain that the rate of suicide remains high on the list only because persons in this age group seldom die of any causes.

During his presentation at the conference, neurologist Dr Fred Baughman, a recognized authority on psychotropic drugs and author of “The ADHD Fraud,” stated: “Psychiatry and the pharmaceutical industry married and launched the joint market strategy of calling all emotional and behavioral problems ‘brain diseases’, due to ‘chemical imbalances’, needing ‘chemical balancers’ – pills.”

“Every time parents are lead to believe that their child’s emotional or behavioral problems are a ‘disease’ due to an abnormality in the brain,” Dr Baughman says, “they are lied to.”

He discussed the overdose death of 4-year-old Rebecca Riley in December 2006, who was diagnosed with ADHD and Bipolar Disorder when she was only 2-and-a half-years old. She was kept on a cocktail of 3 psychiatric drugs, none of which were FDA approved alone for a child her age, much less together, until the time of her death.

The title of his presentation was, “Who Killed Rebecca Riley,” and Dr Baughman placed the blame squarely on the gang of industry shills who are largely credited with the invention and promotion of ADHD and Bipolar Disorders in small children, including among others, Dr Joseph Biederman, Dr Steven Hyman, Dr Jerome Groopman and Dr David Shaffer, the brainchild credited with inventing TeenScreen.

The Fact Sheet reports a 2006 review of the FDA’s MedWatch adverse event database, which found 45 deaths in children due to toxicity of antipsychotics.

Dr Baughman calls the use of the “chemical imbalance theory,” the “biggest health care fraud” and “mass character assassination” in human history, and says it must be abolished.
Dr Dominick Riccio, executive director of the ICSPP, also weighed in on the “chemical imbalance” theory and said that child drugging in the US is based on a “hypotheses with no validity,” propagandized by the pharmaceutical industry.

He warned that there is absolutely no scientific evidence to validate the “chemical imbalance” used to justify the drugging of America’s “most precious commodity,” and “if we continue to damage our children, there will be hell to pay down the line.”

Dr Riccio called for “integrity” in the psychiatric profession and told professionals in attendance, “if you do not understand child development, you should not work with children.”

Washington psychiatrist, Dr Joseph Tarantolo, warned that the new selective serotonin reuptake inhibitor antidepressants are not “selective,” “the drugs are cannons,” he said.
He also explained that the “so-called” antipsychotic drugs do not affect psychosis, “they deaden a person’s response to life.”

According to Dr Tarantolo, because the drugging began 10 or 15 years ago, “we are going to have an epidemic of young adults with yet-to-be-determined neurological problems due to the long term use of psychotropic drugs.”

He says an epidemic is defined as 1% of the population and warns that there will be far more than 1% injured by these drugs.

The bribing of prescribing doctors in the field of psychiatry is rampant. A June 26, 2007, report by the Attorney General of Vermont of payments made to doctors by drug companies during the period July 1, 2005 through June 30, 2006, shows that, by category, psychiatrists were the largest beneficiaries, and 11 psychiatrists received a combined total of $502,612.02, or more than 22% of the overall total of all payments.

For the past 4 years, psychiatric drug makers have remained high on the list of the top 10 spenders in Vermont, with Paxil maker Glaxo holding the number one position in both 2003 and 2004.

An analysis of Minnesota disclosure records by the consumer watchdog group Public Citizen, reported by the Pioneer Press, found a similar windfall for shrinks in that state between 2002 and 2006, with psychiatrists receiving combined payments of $7.38 million.

However, the drug maker’s off-label sales of antipsychotics are now under fire due to the greed involved in the billings submitted for Medicaid patients. In September 2007, Arkansas became the latest state to sue the drug makers when it announced the filing of a lawsuit against Lilly, Janssen and AstraZeneca for “improper and unlawful marketing,” of their drugs and concealing the serious health risks associated with their use.

The Medicaid fraud lawsuits seek to recover not only the money paid for the antipsychotics but also the cost of medical care for all the patients who were injured by the drugs known to cause drastic weight gain, abnormal blood sugars and diabetes.

The bribing of shrinks may be coming to an end as well because, in addition to Medicaid fraud lawsuits, states are also going after the prescribers. On August 16, 2006, the Houston Chronicle reported that five doctors in Texas were notified that they needed to return the Medicaid money paid for drugs they prescribed as part of a two-year effort to better regulate how children are prescribed psychiatric drugs in that state.

The Chronicle reported that a review of a two-month period of Medicaid records in 2004 determined that over 63,000 foster children were on stimulants, antipsychotics or antidepressants, with nearly one-third of the kids taking drugs from more than one of the three classes at the same time and that doctors had filed 114,315 claims worth over $17 million.

The experts at the ICSPP conference reported that the over-prescribing of attention deficit drugs is also out of control, even after the new warnings were issued. The ICSPP Fact Sheet notes that the new labeling changes for ADHD medications include: “Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.”

“Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional can be caused by stimulants at usual doses,” the warning also notes.

Psychiatrist Dr Grace Jackson, author of “Rethinking Psychiatric Drugs,” says the fact that cardiovascular risks are associated with ADHD drugs is not news. “As early as 1977,” she says, “research documented the cell changes associated with heart muscle enlargement in a chronic consumer of Ritalin.”

“The connection between stimulants, cardiovascular disability, and death has long been documented in the medical literature,” she states.

However, no slow down in prescribing rates for these drugs is likely. In 2005, according to a December 15, 2006, report by Research and Markets, the value of the ADHD market was $2.6 billion, and it is now the 9th largest segment of the CNS market with growth of 8% year-on-year. Approximately 90% of global sales were derived from the US in 2005, and by 2012, global sales are forecast to reach $4.3 billion.

In February 2007, the FDA finally directed the drug makers to develop Patient Medication Guides to inform patients about the adverse effects of Adderall, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Metadate CD, Methylin, Ritalin and Strattera.

However, experts say children are being damaged by ADHD drugs in ways that will never show up in a pamphlet. According to child psychiatrist Dr Stefan Kruszewski, “children who are medicated early do not learn to develop coping strategies that work as they move through different developmental stages.”

“We are encouraging a generation of youngsters to grow up relying on psychiatric drugs rather than on themselves and other human resources,” says Dr Peter Breggin, ICSPP founder and author of, “Talking Back to Ritalin.”

“In the long run, we are giving our children a very bad lesson,” he warns, “that drugs are the answer to emotional problems.”

“The problem with the diagnostic assessment of ADHD,” Dr Kruszewski explains, “is that the prescreening statement is so inclusive that virtually every child meets prescreening criteria and therefore every child, under prevailing treatment modalities, becomes eligible for ‘chronic’ medication therapies.”

He also points out that, once children are screened, “they become ‘eligible’ for additional screening for conditions such as social anxiety, bipolar disorder, and obsessive-compulsive disorder, and too often end up on even more drugs.”

Dr David Stein, author of, “Unraveling the ADD/ADHD Fiasco,” also warns that stimulant drugs are “near the top of the heap of potentially addictive drugs.”

He says there is no way of pinpointing which children are at risk of becoming addicted, and “psychiatry has an extremely poor track record for treating addiction problems.”

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, front groups, Kifuji, NAMI, NFC, Spitzer, SSRIs, TeenScreen

World Experts Demand End to Child Drugging in the US – Part II

Evelyn Pringle October 27, 2007

Mathy Milling Downing was a featured speaker at the annual conference of the International Center for the Study of Psychiatry and Psychology and told the audience that her anger is directed toward the FDA and drug companies, “for their incompetence and lack of concern for innocent children they have helped to kill, my little girl included.”

Her 12-year-old daughter, Candace, hung herself from the valence of her bed on January 10, 2004, after being prescribed the antidepressant drug Zoloft for “test anxiety” at school.

Experts in the field of psychiatry and child development from all over the world attended this year’s annual conference in Washington with the agenda aimed at ending the mental health screening programs put in place by the Bush Administration’s New Freedom Commission and the mass-drugging of children with psychiatric drugs.

During her presentation, Ms Downing said she objected to placing Candace on drugs but was assured that Zoloft was safe and did not learn until after her daughter’s death that “up to four children out of every hundred run a risk of dying by their own hand or at least attempt to.”

Had she been given the opportunity to have informed consent on the dangers of SSRI’s, she said, “my child would still be alive.”

“I never would have allowed my child to be placed on a drug with no proven efficacy and a history of possible harm,” Ms Downing stated.

She described how she tried to contact doctors at the FDA numerous times to express her concerns, and no one was ever available to speak to her. She filed a complaint with MedWatch on March 18, 2004, and, “I am still waiting for my reply,” she stated.

“One would think that the FDA would support the needs of Americans over the greed of the various pharmaceutical corporations,” she said, “but that continues to be a pipe dream of mine rather than a reality.”

Critics say TeenScreen, billed as a suicide prevention tool, is nothing more than a drug marketing scheme developed by the pharmaceutical industry and a front group operating under cover of Columbia University to establish a customer base within the nation’s 50-odd million school children for the new generation of psychiatric drugs, including selective serotonin reuptake inhibitor antidepressants (SSRI’s) and atypical antipsychotics.

These so-called new “wonder drugs” include the antidepressants Prozac and Cymbalta by Eli Lilly; Paxil from GlaxoSmithKline; Zoloft by Pfizer; Celexa and Lexapro from Forest Labs; Effexor by Wyeth, as well as generic versions of the drugs. The atypical antipsychotics include Zyprexa by Lilly; Risperdal, marketed by Janssen Pharmaceuticals; Abilify by Bristol-Myers Squibb; Clozaril by Novartis, and Geodon by Pfizer.

Best-selling author of “Mad in America”, Robert Whitaker, tracked the profits of these “wonder drugs” since the first SSRI, Prozac, arrived on the market in 1987 and found a tremendous rise in the cost to taxpayers. In 1987, psychotropic medication expenditures were about $1 billion, but by 2004, in a 40-fold increase, the cost had risen to $23 billion.

According to Mr Whitaker’s analysis, global sales of antipsychotics went from $263 million in 1986 to $8.6 billion in 2004, and antidepressant sales rose from $240 million in 1986 to $11.2 billion in 2004.

In the paper, “Psychiatric Drugs and the Astonishing Rise of Mental Illness in America,” published in the Spring 2005 issue of the Journal of Ethical Human Psychology and Psychiatry, Mr Whitaker also reports that, in addition to breaking sales records, within 10 years on the market, “Prozac quickly took up the top position as America’s most complained about drug.” He further states:

“By 1997, 39,000 adverse-event reports about it had been sent to MedWatch. These reports are thought to represent only 1% of the actual number of such events, suggesting that nearly 4 million people in the US had suffered such problems, which included mania, psychotic depression, nervousness, anxiety, agitation, hostility, hallucinations, memory loss, tremors, impotence, convulsions, insomnia and nausea.”

According to the paper, “It is well-known that all of the major classes of psychiatric drugs – anti-psychotics, anti-depressants, benzodiazepines, and stimulants for ADHD – can trigger new and more severe psychiatric symptoms in a significant percentage of patients.”

Ms Downing has been on a non-stop crusade to prevent the death of more children since her daughter died and the family’s tragedy is featured in the documentary, “Prescription: Suicide,” which also includes the story of 6 families effected by their encounters with SSRIs and how their lives changed forever. A copy of the film is available on the Participate Now web site at http://www.participatenow.net.

Candace should never have been given Zoloft because it was never approved for use with kids. Prozac is the only SSRI approved for children in the US because it is the only drug reportedly shown to be effective in two pediatric clinical trials, a requirement that must be met to obtain FDA approval.

But according to ICSPP founder and leading SSRI authority Dr Peter Breggin, the term “effective” has little meaning because all a drug company has to do is show better results in kids treated with an SSRI than in children taking a placebo and can conduct 100 trials if need be to get the two positive studies. It stands to reason that with 50-50 odds, if enough trials are conducted, an SSRI is bound to do better than a placebo eventually.

However, with that in mind, experts say it’s important to note that, other than Prozac, the SSRI makers have not been able to provide the FDA with 2 positive studies out of all the clinical trials that have been conducted in hopes of obtaining FDA approval for the sale of SSRI’s to kids.

That said, SSRI makers have made a fortune by getting doctors to prescribe the drugs for unapproved uses. A University of Georgia study in the June 2006 Journal of Clinical Psychiatry found that 75% of persons prescribed antidepressants received them off-label. The researchers reviewed records of more than 106,000 Medicaid recipients in 2001 to examine the rates of off-label prescribing of drugs that act on the central nervous system and found 75% of antidepressant patients received the drugs for unapproved uses.

“More than two-thirds of the studies of antidepressants given to children showed that the medications were no more effective than a placebo, and most of the positive results came from drug company sponsored trials,” Dr Karen Effrem reported in her presentation at the ICSPP conference.

Litigation against drug companies has established this fact. In 2004, New York State Attorney General Eliot Spitzer brought fraud charges against Glaxo for hiding studies that “not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.” Two months later, Glaxo agreed to pay $2.5 million to settle the charges.

Mr Spitzer pointed out that Paxil was never approved to treat any condition in children, and yet doctors prescribed the drug to kids two million times in 2002, the same year that Paxil became Glaxo’s top seller with $3.8 billion in sales.

On November 1, 2006, the Associated Press reported that Glaxo “has agreed to pay $63.8 million to settle a lawsuit’s claims that it promoted its antidepressant drug Paxil for use by children and adolescents while withholding negative information about the medication’s safety and effectiveness.”

Critics say it’s not difficult to track the industry money involved in the promotion of TeenScreen. The program’s Executive Director, Laurie Flynn, was the Executive Director of National Alliance for the Mentally Ill (NAMI) for 16 years, which bills itself as a patient advocacy group, but in reality is the most heavily industry-funded front group in the US.

Mother Jones Magazine obtained NAMI documents for the period between 1996 and mid-1999, while Ms Flynn was running the show, which revealed that NAMI received a total of $11.72 million during that 3-year period from 18 drug companies, including Janssen, $2.08 million; Novartis, $1.87 million; Pfizer, $1.3 million; Abbott Laboratories, over $1.24 million; Wyeth-Ayerst, $658,000, and Bristol-Myers Squibb, $613,505.

NAMI’s top donor during that period was none other than Lilly, the maker of Prozac and Zyprexa, which coughed up a total of $2.87 million out of the goodness of its heart.

Ms Flynn also wrote an article promoting TeenScreen entitled, “Before Their Time: Preventing Teen Suicide,” in which she stated: “The TeenScreen Program developed 10 years ago by Columbia University and offered in partnership with the National Alliance for the Mentally Ill helps communities across the nation identify teens with mental illness who might be at risk for suicide.”

If TeenScreen is “offered in partnership” with NAMI, critics say, it goes without saying that millions of dollars of drug company money was invested in the program.

The efforts to implement TeenScreen by use of “this partnership” cannot be understated. A video-taped presentation at the annual convention of NAMI, obtained by researcher Sue Weibert, shows the TeenScreen crew telling the army of NAMI members from all across the country that helping set up TeenScreen might require contacting a child’s insurance company to check on coverage or driving a child to an appointment with a psychiatrist.

The video also shows the presenter passing around a notebook for signatures from members who would be willing to act as volunteers and rise up against anyone who speaks out against TeenScreen.

The presenter also explains the importance of bribing kids with movie coupons, pizza or other perks, because parents won’t agree to allow the children to be screened, so they need to win the kids over first and send them home to talk the parents.

Early on, NAMI and TeenScreen did not even hide the fact that drug money was funding the screening. In June 2002, the Tennessee Department of Mental Health and Developmental Disabilities Update Newsletter reported that NAMI and Columbia University sponsored the screening of 170 Nashville students with TeenScreen and that the survey was funded by grants from AdvoCare and Eli Lilly.

But two years later, in March 2004, Ms Flynn appeared at a congressional hearing trying to drum up the allocation of tax dollars to set up TeenScreen in public schools. During her testimony, she as much as defined the customer base the drug companies were after when she told the lawmakers that, “close to 750,000 teens are depressed at any one time, and an estimated 7-12 million youth suffer from mental illness.”

On September 27, 2007, psychologist Michael Shaughnessy, professor in Educational Studies at the Eastern New Mexico University and columnist for the educational news and information site, EdNews.org, was interviewed about his views on TeenScreen by Doyle Mills, an independent researcher in Clearwater, Florida who was instrumental in blocking TeenScreen from setting up shop in schools in Pinellas and Hillsborough Counties, two of Florida’s most populated counties, and has published several articles critical of TeenScreen.

Mr Mills shared his interview with Dr Shaughnessy at the ICSPP conference, in which the Professor called TeenScreen “a program aimed at locating, identifying and procuring new customers for the mental health industry.”

He says TeenScreen is a creation of psychiatrist David Shaffer, a paid spokesman for Lilly and paid consultant for drug companies Hoffman la Roche, Wyeth and Glaxo.

TeenScreen started out by claiming the program was free and required no government funding. But as it turns out, taxpayers are funding this marketing scheme from start to finish. Government money is being used to set up TeenScreen in schools all over the US and tax dollars are paying not only for the follow-up visits to prescribing shrinks but also for the majority of drugs prescribed.

The pilot programs of TeenScreen in five counties in Ohio were funded by five $15,000 grants allocated by mental health boards within the Ohio Department of Mental Health.

Medicaid record show that taxpayers in Ohio are footing the bill for most of the child drugging as well. In July 2004, over 39,000 children covered by Medicaid were found to be taking drugs for depression, anxiety, delusions, hyperactivity and violent behavior, and Medicaid spent more than $65 million for mental health drugs prescribed to children in 2004, according to an investigation by the Columbus Dispatch.

The massive drugging of patients covered by public health care programs is similar in states all across the US. In 5 years, prescription costs for Iowa Medicaid increased 82.5%, and by class, antipsychotics reflected the largest increase for mental health drugs.

In 2005, while the average cost for a first generation antipsychotic to Medicaid was only $36 a month, a month’s supply for a new antipsychotics cost between $100 – $1,000, according to the December 8, 2005, Mental Health Subcommittee Report to the Medical Assistance Pharmaceutical and Therapeutics Committee.

For the record, TeenScreen is not free, and it is costing tax payers a bundle. On November 17, 2004, the University of South Florida announced the receipt of a grant of $98,641 from the US Substance Abuse and Mental Health Services Administration to expand the TeenScreen program in the Tampa Bay area.

Florida Medicaid is also being bilked. On July 29, 2007, the St Petersburg Times reported that, in the last 7 years, the cost to taxpayers for atypicals prescribed to kids rose nearly 500%, and on average it cost Medicaid nearly $1,800 per child in 2006.

The Times reported that more than 18,000 kids on Medicaid were prescribed antipsychotics in 2006, including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration says that, with children under 6, psychotropic drugs should “only be considered under the most extraordinary of circumstances.”

In setting up TeenScreen to screen students in Brimfield, Illinois, “organizing the system and employing a part-time counselor specifically for the program is estimated to cost about $100 per student,” the July 11, 2005, Peoria, Illinois Journal Star reported.

Overall, the “Brimfield High School program alone will cost around $20,000 for the first semester,” the Journal noted.

The TeenScreen gang claims that it always obtains parental consent prior to screening students and that it does not diagnose students with mental disorders.

However, Michael and Teresa Rhoades, from Indiana, attended the DC conference and as a featured speaker, Teresa described how her daughter was TeenScreened in December 2004, without parental consent, and was told that she had not one, but 2 mental illnesses.

Teresa recalled the day that her distraught daughter came home and informed her parents that she had been diagnosed with obsessive compulsive disorder and a social anxiety disorder.

Michael and Teresa say they were furious to the point that they filed the nation’s first lawsuit against TeenScreen, charging that their daughter was wrongly screened, diagnosed, and labeled mentally ill in a public school without their consent.

“TeenScreen itself is a questionnaire with invasive and probing questions which indoctrinate young people into a belief that all their feelings and behaviors are indications of a mental disorder,” Dr Shaughnessy told Mr Mills in the interview.

He said, “the child is convinced of it, the parent is convinced of it, and then the child becomes a customer of TeenScreen’s local mental health ‘partner,’ which sells counseling or drugs and profits tens of thousands of dollars per child.”

Dr Shaughnessy acknowledged that adolescence is a hard time for everyone but said, “maybe it’s supposed to be,” that’s how we learn.

He says TeenScreen labels the normal pain and uncertainty of adolescence as a mental disorder for profit and asks, “When did adolescence become a disease or something unnatural or deadly that needs intervention if anyone is going to make it through?”

“”What a ridiculous concept,” Dr Shaughnessy added.

He also points out that school records for children are intended to be secure but says, once committed to paper or computer, nothing can be 100% secure. “Normal school records are fairly harmless no matter who sees them,” he states.

“TeenScreen records on the other hand,” he warns, “contain unscientific evaluations which can be taken to mean that the child has a permanent, incurable mental disorder.”

He also says these records can then be used against a child as an adult, to take away his rights, limit his opportunities or “just as a horrible embarrassment.”

“As there is no scientific way to prove that anyone has a mental disorder,” Dr Shaughnessy points out, “there is likewise no scientific way to disprove it.”

He told Mr Mills that this is one aspect that parents are never made aware of prior to allowing TeenScreen access to their children. “Once a person is diagnosed, he may never be able to escape that label,” he warns.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, front groups, NAMI, NFC, Spitzer, SSRIs, TeenScreen

Attorney Subpoenas J&J, AstraZeneca and Lilly for Hidden Antipsychotic Data – Part I

Evelyn Pringle September 10, 2007

Alaska attorney Jim Gottstein has issued subpoenas for the discovery of any suppressed data on the atypical antipsychotic drugs Zyprexa, Risperdal, and Seroquel which he says is necessary before a Forced Drugging Petition can possibly be considered for approval for a client he is representing.

Mr Gottstein contends that the information sought from Eli Lilly, AstraZeneca and Johnson & Johnson will show that the side effects of the drugs were well-established by the drug makers’ own clinical trials and therefore, his client should not be forced to take such medications against his will.

According to Mr Gottstein, various off-label combinations of Risperdal, Seroquel, Zyprexa and the anti-seizure drug Depakote have been administered to his client in the past, over his objections, which have not been FDA approved as safe or effective for use in any patient.

The subpoena issued to Sidney Taurel, Chairman and CEO of Eli Lilly calls for the production of the same documents requested by Congressman Henry Waxman (D-Cal), as chairman of the House Oversight and Government Reform Committee, on March 1, 2007.

On March 1, 2007, Rep Waxman sent letters to both Lilly and AstraZeneca, requesting extensive information about their marketing practices. The letter to Lilly states in part, “Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa,” and requests information relevant to these allegations.

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

The letter to Astra basically asks for the same documents except that Rep Waxman asks for more information related to the physicians and authors involved in company sponsored studies on Seroquel and writing the reports.

However, Rep Waxman also asked Lilly to turn over a batch of documents that were kept under seal for years with a court order issued by a federal court in New York, but were provided to him by Attorney Gottstein in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

Mr Gottstein originally obtained the documents by subpoenaing Dr David Egilman, who served as a plaintiffs expert witness in the Zyprexa Products Liability litigation, pending in the United States District Court in the Eastern District of New York (MDL 1596), for a case unrelated to the Products Liability case.

The MDL 1596 litigation involved tens of thousands of lawsuits filed by Zyprexa victims who alleged that Lilly illegally marketed the drug for off-label uses and concealed the serious side effects known to be associated with Zyprexa for a decade.

As soon as Mr Gottstein received the documents he provided copies to reporter, Alex Berenson, at the New York Times, and to a number of other journalists, patient rights activists and advocacy groups and several leading experts on psychotropic drugs.

Once a medication is approved to treat one condition, doctors may prescribe it off-label for other indications if they think it will be effective, but drug makers are barred by law from encouraging physicians to prescribe a drug for uses other than those listed on the FDA approved label. But in recent years, its a well-known fact that off-label promotion has become the industries primary marketing tool when it comes to psychiatric drugs.

“Off-label” use also includes treating an approved condition for a longer duration of time, or in combination with other drugs, or at a different dosage, or with a different patient population such children or the elderly, than are listed on the label.

Zyprexa (Lilly), Risperdal (J&J) and Seroquel (AstraZeneca) belong to a class of drugs known as “atypical” antipsychotics. The other atypical drug include Abilify (Bristol Meyers Squibb), Geodon (Pfizer) and Clozril (Novartis).

The drugs were FDA approved only to treat schizophrenia and the manic phase of bipolar disorder in adults and have never been approved for use in combination with each other.

The many lawsuits filed against Lilly allege that the company’s off-label marketing campaigns included influencing doctors to prescribe the drug to millions of patients ranging from toddlers to the elderly for an exhaustive list of unapproved uses such as anxiety, sleep disruption, mood swings, post-partum depression, autism, attention deficit hyperactivity and dementia.

According to Harrisburg Pennsylvania psychiatrist, Dr Stefan Kruszewski, the atypical drugs can increase the risk of drastic weight gain, diabetes, pancreatitis, hypertension, heart attacks and stroke.

“The drugs can cause both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems,” he explains, “at the same time that they cause the neurological side effects as the older antipsychotics such as akathesis, a severe restlessness and tardive dyskinesia an often irreversible movement disorder.”

As an expert witness in the case, Dr Egilman reviewed the Lilly documents kept under seal by the court order and learned that Lilly had indeed engaged in a massive off-label marketing scheme to increase profits by encouraging doctors to prescribe the drug for unapproved uses and had concealed the drug’s serious side effects.

As a physician, after learning what was in the documents and knowing the harm that was sure to come to patients who continued to take Zyprexa, Dr Egilman was clearly facing a major ethical dilemma.

At the time, Lilly had already managed to keep the documents hidden by settling out of court with about 8,000 Zyprexa victims in 2005 by paying close to $700 million, after only five plaintiffs had provided depositions and before any substantive depositions could be taken from any of the Lilly defendants.

And the first batch out of court settlements did nothing to deter the off-label sales of Zyprexa. According to Lilly’s SEC filings, sales in the second quarter of 2006 totaled $1.12 billion, or a 2% increase over the second quarter of 2005.

In addition, Dr Egilman was aware that the company was getting ready to settle with about 18,000 more Zyprexa victims, and that the second round of settlements would guarantee that the secret documents would remain sealed.

And as a condition of settlement, the 28,000 plaintiffs had to sign agreements promising never to discuss the charges made against the company related to Zyprexa.

According to several plaintiffs who settled out of court, they we were not aware that there were documents that showed in many instances that Lilly knew full well that the injuries suffered could occur and had intentionally concealed the information from doctors and patients because it would have had a negative impact on Zyprexa sales.

In fact, these plaintiffs said they were never told that these secret documents even existed much less that by signing settlement agreements they would be allowing more patients to be injured or killed because the documents would remain sealed.

They also said that they were completely surprised to learn that their attorneys had access to documents that could have been presented to a jury to prove that the allegations in their lawsuits were true when the media began reporting the story in December 2006.

For instance, a November 12, 1999, letter from a Dr Albert Marrero, to Lilly’s medical director, described the blood sugar problems occurring in patients. “We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars,” he stated.

Dr Marrero also told Lilly: “Two patients had to be hospitalized due to out of control diabetes….We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent,” he wrote.

A November 1999 report showed that after examining 70 clinical trials, Lilly found that 16% of patients on Zyprexa for a year had gained over 66 pounds but instead of informing doctors of this information, the company used data from a smaller group of trials to say about 30% of patients gained only 22 pounds.

Another document showed that in 2000, after a group of diabetes doctors retained by Lilly substantiated the diabetes risk, a Lilly manager stated in an email, “unless we come clean on this, it could get much more serious than we might anticipate.”

A email dated two years later in March 2002, shows that Lilly shot down a plan to provide doctors with information about diabetes, because it would draw too much attention the risk. “Although M.D.’s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa,” the email stated.

Although the documents clearly show that Lilly had knowledge of these life-threatening health risks in 1999, it did not add a warning about blood sugar levels and diabetes to the Zyprexa label until the FDA forced it to in the fall of 2003. In fact, Japan and the UK issued warnings about the increased risk of diabetes in 2002.

According to Ellen Liversridge, whose son took Zyprexa and gained 100 pounds before he fell into a coma and died of profound hyperglycemia in 2002, “both the FDA and Lilly fought putting a warning on the label, until articles on the front pages of the New York Times, Baltimore Sun, and Wall Street Journal so embarrassed the FDA that they finally gave in to adding the warnings.”

But even then she says, the FDA required the same warning on the labels of all atypical drugs, “when Zyprexa was associated with a 37% higher increase in the risk of diabetes when compared to other medications.”

However, the secret documents show that Lilly was hard at work behind the scenes to make sure that the new warnings would have minimal effects on Zyprexa sales. A July 7, 2003, memo titled, “Diabetes Update,” described a plan to protect doctors who were afraid of being sued for prescribing Zyprexa after the news of the diabetes risk became public that would indemnify doctors who continued to prescribe drug

“We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase),” the Update said,
“solely on the basis of personal fear (of being sued).”

“Indemnification represents the most meaningful demonstration of confidence in Zyprexa–both with our customers and with our employees,” it stated.

The memo also discussed a plan to pay millions of dollars to the National Alliance on Mental Illness, the most notorious industry backed front group in the nation, to help downplay the news about the diabetes risk.

The public health crisis created by patients who developed diabetes as a result of using Zyprexa is real. A Medicaid fraud lawsuit filed against Lilly by the attorney general of Mississippi in July 2006, alleges that about 10% of patients who used Zyprexa in that state have developed insulin-dependent diabetes and some are children, the complaint says.

When forced to make a decision on whether to warn the public about Zyprexa or abide by a court order that could result in the death and injury of thousands upon thousands of more people, Dr Egilman obviously followed the natural instinct of any decent human being and gave up the documents.

Whether or not he actually realized what consequences he might face is anyone’s guess, but he no doubt recognizes the consequences of crossing the drug giant today.

On September 7, 2007, Lilly issued a press release with the headline: “Egilman Admits Wrongdoing in Illegally Releasing Documents to New York Times and Resolves Case to Avoid Possible Civil and Criminal Sanctions”.

The release said that Dr Egilman will pay $100,000, and in return, the company “agreed to forego seeking criminal and civil penalties against Dr. Egilman for his illegal activities.”

Although it will be interesting to see how many “Good Samaritans” will stick their neck out for the common good after hearing about Dr Egilman’s fate, it is apparently still easy to find doctors willing to prescribe Zyprexa off-label because SEC filings show Lilly earned $4.36 billion from the drug in 2006

With all that said, on September 6, 2007, it was certainly a Deja Vue moment when the judge in Mr Gottstein’s latest case against forced drugging in Alaska, issued an order to have the court hearing and file closed, even though the client had elected to have it open.

Filed under: 2007, antipsychotics, drugging children, Zyprexa

Attorney Subpoenas J&J AstraZeneca and Lilly for Hidden Antipsychotic Data – Part II

Evelyn Pringle September 10, 2007

Attorney Jim Gottstein is the director of the Law Project for Psychiatric Rights, a public interest law firm that has mounted a campaign against forced psychiatric drugging all over the country. He represents mostly indigent clients through his non-profit organization and is not involved in the lawsuits filed against the atypical makers by patients or their families.

In turning the secret Eli Lilly documents over to the press, Mr Gottstein’s goal was the same as Dr David Egilman’s, to alert the public about Lilly’s off-label marketing schemes aimed at getting doctors to prescribe Zyprexa to more patients who were unaware of the serious health risks associated with the drug.

Zyprexa was approved only for the treatment of adults with schizophrenia in 1996, and it wasn’t until several years later, that it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.

In a February 13, 2007, interview with the Anchorage Daily News, Mr Gottstein explained that the secret document showed the rate at which Zyprexa caused diabetes, massive weight gain and other metabolic problems and how Lilly trained sales staff to mislead doctors about the drug’s association with diabetes and illegally promoted Zyprexa for off-label use with children and the elderly.

As the playing field stands today, the average American alone would be lucky to find any law firm financially strong enough to take a drug giant like Lilly with its billions of dollars of power and a well that will never run dry in large part because the illegal off-label marketing of Zyprexa is ongoing and continues to earn billions of dollars each year.

However, a small group of patient advocates that included some of the most well-known psychiatric drug experts, journalists, and attorneys in the US went head to head with Lilly in the public battle in a US District Court in New York that dragged out over 2 months to lift an injunction that barred the public disclosure of information about the serious adverse effects of Zyprexa that Lilly had successfully kept hidden under a court order until the documents were leaked to the press in December 2006.

Lilly filed the motion for the injunction in attempt to get the documents back under seal and succeeded in muzzling just about every expert in the US involved in the fight to dismantle the mass-drugging schemes put in place by the pharmaceutical industry over the past 10 years including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, and Dr Stefan Kruszewski, as well as the award winning journalist, Robert Whitaker, who wrote “Mad in America,” and revealed all the negative information that showed up in the clinical trials conducted on Zyprexa and the other atypicals.

The score looked bad for the home team early on when Lilly won the second round by getting the court to add the names of two of the world’s most powerful patient advocacy groups to the injunction, along with their internet web sites and leaders, including Vera Sharav, director of the Alliance for Human Research Protection, and Judy Chamberlin and David Oaks from the international organization MindFreedom, a coalition of about 100 advocacy groups in 13 different countries.

At the time, Mr Oaks said, “This appears to be about Eli Lilly using its billions of dollars to try to intimidate grassroots critics.”

The New York legal battle turned into an all out war when Ms Sharav and Dr Cohen brought in the high profile attorney, Alan Milstein, to file their own motion asking the judge to unseal the documents because they should have never been designated confidential to begin with.

“What is abundantly clear,” Mr Milstein told the judge in a hearing, “is that they are not trade secrets.”

“Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo,” he said.

“What Lilly wants to prevent, is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it,” Mr Milstein said in the hearing.

Alaskan Attorney, John McKay, stepped in to represent Mr Gottstien and his wife Terrie, and then attorney, Fred von Lohmann of the Electronic Frontier Foundation, widened the battlefield by filing a brief on behalf of John Doe, described as a citizen-journalist who wanted to publish the secret documents on web sites because they were “plainly related to a matter of overriding public concern.”

California attorney, Ted Chabasinski, jumped in the ring on behalf of Robert Whitaker, Judi Chamberlin, and David Oaks. “While the injunction purports to be an attempt to recover the documents,” he wrote in a letter to the judge, “it is clear that its real purpose is to intimidate Lilly’s critics, and the court should refuse to cooperate with this.”

Mr Chabasinski told the court that criminal charges should be filed against Lilly executives for illegally marketing Zyprexa for unapproved uses, with full knowledge that thousands of patients were being injured and killed. “If executives can go to prison for stealing their companies’ money,” he told the judge in a letter, “surely those who steal people’s lives deserve at least the same fate.”

Mr Chabasinski informed the court that the secret documents were evidence of Lilly executives’ “criminal behavior” and their “willingness to kill people for profit.” He also made it known that he was encouraging members of the public to contact state attorney generals and was directing private citizens to a list of current contact information for each state posted on the Mindfreedom web site.

And some citizens did just that. Richard Bleecker, whose nephew died unexpectedly of hyperglycemia due to Zyprexa, wrote to the New Jersey attorney general and stated: “In your capacity as New Jersey’s Attorney General, I ask that you launch an investigation into Eli Lilly’s violation of the public interest by its concealment of the risks of Zyprexa.”

“Despite the FDA restrictions on use and warning labels,” he wrote, “the drug continues to be vigorously promoted by Lilly and prescribed for patients in record numbers, including children.”

He pointed that the state itself had an interest in the matter “since government programs like Medicare and Medicaid purchase over 70% of the Zyprexa sold in the USA, taxpayers in our State as well as across the nation are footing most of the bill.”

“I appeal to you, to investigate Eli Lilly’s willingness to see patients suffer and die to enhance its profits,” Mr Bleeker wrote.

Over 10 states have now sued Lilly for Medicaid fraud over the off-label marketing of Zyprexa. And for good reason according to a report in the March 23, 2007, New York Times, that said Zyprexa costs more than $300 a month and is the single biggest drug expense for state Medicaid programs with spending of more than $1.3 billion in 2005.

During court hearings, several people restrained by the injunction testified about why the documents should be made public which resulted in media reports about what was in them before the legal battle even ended.

For instance, at a January 17, 2007, hearing, Mr Gottstein was asked, “at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?”

And he answered: “Absolutely.”

He was then asked whether he feared there would be thousands more cases of harm to people from Zyprexa, while Lilly was settling cases out of court, and Mr Gottstein said yes, and that he wanted the documents released “to protect people from this drug.”

Mr Milstein told the judge that the documents were critically important to saving human lives and said, “this Court should in no way assist Lilly in keeping them from the public.”

At the same hearing, Lilly attorneys asked Ms Sharav why she was interested in the documents and she said because they documented the fact that Lilly knew in 2000, that Zyprexa caused diabetes, “from a group of doctors that they hired who told them you have to come clean.”

“And instead of warning doctors who are widely prescribing the drug, Eli Lilly set about in an aggressive marketing campaign to primary doctors,” she testified.

Ms Sharav told the court, “This is a safety issue,” and “to continue to conceal these facts” from the public “is not in the public interest.”

She said, “this is about the worst that I have seen.”

“It borders on indifference to human life,” she told the judge. “Eli Lilly knew that Zyprexa causes hypoglycemia, diabetes, cardiovascular damage and they set about both to market it unlawfully for off label uses to primary care physicians.”

She said Lilly taught primary care doctors to diagnose patients as bipolar if they experienced mania after taking antidepressants. “That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General,” she testified.

Mr Sharav also objected to the off-label sale of Zyprexa to kids. “Little children are being exposed to horrific diseases that end their lives shorter,” she testified.

She said, “the reason the drug became a four and a half billion dollar seller in the United States is because they encouraged the prescription for children, for the elderly, for all sorts of reasons.”

“I consider that a major crime,” she told the judge and said she asked Mr Gottstein for 2 copies of the documents so that she could deliver one copy to the New York attorney general.

By the time of that hearing, Ms Sharav no doubt was aware that the crime was ongoing because in January 2006, USA Today reported that although the atypicals are not approved for any use with children, the prescription rate for children “is growing dramatically faster than the rate for adults,” quoting Robert Epstein, chief medical officer for Medco Health Solutions, pharmacy benefit managers.

In addition, an assessment by Christoph Correll, of the Child and Adolescent Psychiatric Clinics of North America, showed Zyprexa to be the worst of the atypicals for kids and listed the side effects of diabetes and weight gain with the drug as “severe.”

Technically, on February 13, 2007, Lilly scored a knock-out punch when the judge issued a permanent injunction prohibiting Mr Gottstein and Dr Egilman from further disseminating the documents and allowed Lilly to keep them sealed under a court order.

However, the judge also acknowledged in his written ruling that there was no way he could not enjoin the world by extending the injunction to the internet and by that time the worldwide web was flooded with all the damning information.

And Lilly would soon learn that the push to make the information public extended far beyond the courtroom. On February 23, 2007, a grass roots advocacy group issued a press release to rally support for Mr Gottstein for providing the documents to the media and to announce the “The Just Say “Know” to Prescription Drugs Campaign,” with a goal of getting one million people reevaluate the prescription drugs they were taking.

“If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it,” said Dr Greg Tefft, co-founder of the Campaign.

“We’re talking 20 million people potentially at risk and more being added daily,” he added.

The group set out to educate the public about off-label prescribing and what consumers must do to protect themselves against Zyprexa, or other drugs, when they are prescribed without warnings about side effects or unapproved uses.

“We are convinced that the way to solve this problem is to work the demand side of the market,” Dr Tefft said. “We are going directly to consumers and encouraging them to know what they are taking.”

Chairman of the Campaign, Dr Dominick Riccio, hosted a Zyprexa radio series and Dr Laurence Simon provided information to consumers about the drug and they set up an official web site for the Campaign is http://justsayknow.kpncradio.com

A month and a half later, on April 4, 2007, the ranking Republican on the Senate Committee on Finance, Senator Charles Grassley (R-Iowa), was knocking on Lilly’s door with a letter to the CEO saying, “I have an obligation to ensure that the public’s money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs.”

“I am aware of several pending products liability actions regarding Zyprexa,” he said, “and questions have been raised regarding safety information and marketing practices relating to that drug.”

Senator Grassley also wrote, “I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee,” referring to leaked documents and said, “please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available … pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig.”

And in the end, it could be said that injunction or no injunction, the small group of warriors led by Mr Gottstein and Dr Egilman, who bravely banded together against the billion dollar giant helped make Lilly’s worst nightmare come true by fighting against the injunction and keeping the spotlight on the documents that the company fought so hard to keep hidden, not so much from the public, but from the stockholders.

According to legal experts, Lilly’s desperate filing for the injunction had nothing to do with the lawsuits filed by private plaintiffs because that litigation was the least of its worries being the company was settling the cases for peanuts with plaintiffs signing confidentiality agreements that would shut them up for life.

However, following the public disclosure of proof that Lilly had engaged in a 10-year illegal off-label marketing scheme while concealing the adverse effects of Zyprexa, the company was hit with the big Kahoona, when 4 class action lawsuits were filed in April 2007 on behalf of shareholders, alleging the fraud by Lilly and its top executives had cost them more than $30 billion, and the evidenced cited to support the allegations was the information from the secret documents that resulted in the battle over the injunction.

It remains to be seen whether these shareholder lawsuits will do anything to stop the drugging of kids in the US because as it stands right now the mass drugging campaign appears to be unstoppable. On September 5, 2007, Rob Waters reported that the number of antipsychotic prescriptions for children doubled to 4.4 million between 2003 and 2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a drug-tracking firm.

Mr Waters also reported that the growth was most dramatic in the youngest children with 20,280 prescriptions written for kids aged 4 and younger, a five-fold increase over 2003, and with 5- to 9-year-olds, prescriptions increased almost six-fold to 710,937 in 2006.

Filed under: 2007, antipsychotics, drugging children, KOL, Zyprexa

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