Drug Companies Still Peddling Risperdal & Zyprexa

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Drug Companies Still Peddling Risperdal & Zyprexa

Monday, 19 June 2006, 11:07 am

Opinion: Pringle

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

By Pringle

According to 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.

, 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 &

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 ph 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 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

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 Magno

Zito, an associate professor of pharmacy and medicine at the University of

land 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 .

Former Medicaid program investigator, 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 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--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 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 Whitaker in an interview with 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 J Weiden, 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 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 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 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.

*************

For more information for injured parties go to Lawyers and Settlements.com

http://www.lawyersandsettlements.com/articles/zyprexa_Off_Label.html

Pringle

( Pringle is a columnist for OpEd News and an investigative journalist

focused on exposing corruption in government and corporate America)