Atypical Drug Users Angry

[Guest guest]

It sickens me even more, as I read below ( " Atypical Drug Users Angry " ), of all

the same complaints which I made about Texas over-sight corruptions, corruptions

in Hood County Court (where the brother of the Republican District Judge, while

acting as Attorney AdLitem turned Mom's guardianship into an arena of deceit to

cover up for the nursing home criminals, allowing Mom's continued torture, and

robbing her estate for his arena of deceit), corrupt and evil nursing homes who

have been indicted for contributing illegally to the Republican Party (those

contributions happening the same time period that Mom's torture was allowed and

contributed to by those we pay to serve and protect), the same deadly drugs, the

same tortures that my mother and others were subjected to, as I reported toTexas

DHS (now DADS), the Texas Attorney General's MEFU, Texas OIG, the local D.A.,

Senator Kip Averitt, and Representative Jim Keffer.

Of-course I paid a high price for trying to stop Mom's tortures, as it cost me

my 70,000 dollars per yr. job. But, far more damaging to me is the memories of

the emotional and physical torture that Mom was put through for 4 horrible years

(2001-2004), until they euthanized her, apparently to cover-up their ongoing

neglects and abuses. Texas DHS joined in retaliate lies and they continued even

after my mother's killing. I have much hard evidence It is well documented and

distributed to advocates through out the U.S. (just in case those who have tried

to intimidate me into silence think that eliminating me will make the facts go

away). I guarantee that I will not be silent; and, I will die proud in exposing

these ethically and morally challenged who have apparently corrupted every level

of the government that I and others were once proud of.

I found out the hard way in Texas, long before the few medias which are willing

to tell the truth started reporting. It is refreshing that there are some who

value citizens lives over " big pharma's advertising dollars. Now, if only

politicians and government officials would show the moral courage to stop these

killings, tortures, and frauds of our citizens. There are more victims of these

crimes than the events of 911; but, the criminals are still free to harm, kill,

and rob again.

Most determined to see these evil predators of our most vulnerable citizens

exposed and prosecuted,

Durant (Mother's Advocate)

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Health

Why are atypical drug users angry?

By Pringle

Online Journal Contributing Writer

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August 19, 2005-We now know that atypical antipsychotics are responsible for a

high incidence of diabetes, stroke, endocrine, cardiac problems and movement

disorders.

In recent years, drugmakers have been forced to admit to misleading the FDA,

physicians, and consumers about the deadly side effects of these drugs. But they

are still routinely prescribed to patients of all ages, including children and

the elderly.

On April 12, The New York Times reported that the FDA will now require black box

warnings about the increased risk of death on the labels of some of the most

aggressively marketed, hence widely prescribed drugs such as Zyprexa (Eli Lilly)

Risperdal ( & ) Abilify (Bristol-Myers Squibb), Clozril

(Novartis), Geodon (Pfizer).

On July 24, 2004, the Miami Herald reported that the maker of Risperdal " has

acknowledged misleading doctors and other healthcare providers about the safety

of the product, minimizing potentially deadly side effects. "

" Risperdal is the leading drug used to combat schizophrenia and other types of

psychotic disorders, earning Janssen about $2.1 billion in annual sales, " the

Herald wrote. " The drug was first marketed about eight years ago, and is

prescribed to more than 10 million people worldwide. "

The worst part of this tragedy is that atypicals are not even effective. One

review of 52 studies involving 12,649 patients published in the December 2000

British Journal of Psychiatry reported: " There is no clear evidence that the

atypical antipsychotics are more effective or better tolerated than conventional

antipsychotics. "

While the health and drug control agencies of Japan and Great Britain issued

warnings against the drug Zyprexa in 2002, the FDA continued to allow its sale

and distribution until September 2003, before it finally required a warning

label on the drug.

The FDA made all atypicals carry the same warning label even though the risk of

diabetes with Zyprexa was 37 percent higher than with the other atypicals.

In February 2004, the American Diabetes Association, the American Psychiatric

Association, the American Association of Clinical Endocrinologists and the North

American Association for the Study of Obesity published a joint statement

confirming the association between Zyprexa and diabetes.

An independent researcher, Dr Healy, studied FDA raw data on Zyprexa and

concluded that it was among " the deadliest drugs ever to gain FDA approval. "

Yet, despite all the warnings of adverse affects and lack of effectiveness,

atypicals are being prescribed for patients in record numbers, including

children. On April 25, the Ohio Columbus Dispatch reported an investigation of

state Medicaid records that found 18 newborn to 3 year-old babies in Ohio had

been prescribed antipsychotic drugs in July 2004.

According to CBS.marketwatch.com on February 7, atypical Zyprexa, earned Eli

Lilly $4.4 billion in 2004. A considerable amount when compared to Lilly's $13

billion total net sales in 2004. The global giant also produces other

psychiatric drugs such as Prozac, Strattera, and Symbyax.

In 2003, Zyprexa became Lilly's top seller with worldwide sales of over $4

billion. According to The New York Times, 70 percent of the Zyprexa purchased in

the US in 2003 was paid for by government programs like Medicare and Medicaid.

The State of New York's $4-billion-a-year bill for drugs covered by Medicaid is

the biggest in the nation. In the first 10 months of 2003, the state spent $205

million on Zyprexa alone, far more than for any other one drug.

The state of California spent over $500 million on the atypicals Risperdal,

Zyprexa and Seroqual in 2003.

In a New York Times Article (Leading Drugs for Psychosis Come Under New

Scrutiny), a Goode reported a study by the Department of Veterans Affairs

which found that Zyprexa cost the VA $3,000 to $9,000 more per patient each year

than conventional drugs, with no benefit to symptoms, side effects or overall

quality of life.

Today, a month's supply of Zyprexa is 10-30 times more expensive than a month's

supply of a conventional antipsychotic, according to Leonard Roy , author

of Zyprexa: A Prescription for Diabetes, Disease and Early Death in the August

2005 Edition of Street Spirit.

Its ironic, that in the same year that the FDA got around to forcing the company

to warn of the drug's link to diabetes, Lilly's second most profitable line of

products was drugs used to treat diabetes, which grossed $2.51 billion in 2003.

The profits from the sale of these drugs are not being spent on research and

development, they in large part go for marketing and salaries for top

executives. A report by the non-profit group Families USA showed that in 2001,

former CEO of Bristol-Myers Squibb, Heimbold Jr, received $74,890,918,

not counting his $76,095,611 worth of unexercised stock options, and the

chairman of Wyeth raked in $40,521,011, plus $40,629,459 in stock options.

Eli Lilly is currently under fire from the FDA, state attorneys general,

doctors, and consumers, with complaints about Zyprexa.

On August 3, Reuter's reported that Lilly had received a subpoena from the

Florida attorney general's office seeking documents on Medicaid-related sales of

Zyprexa and Lilly's marketing of the drug.

In a regulatory filing, the drugmaker said it had received the subpoena in June

from the Medicaid Fraud Control Unit and said it was possible that other Lilly

products could become subject to the investigation and that the investigation

could lead to criminal charges, fines or penalties against the company.

The Florida investigation comes amid a continuing investigation by the US

attorney for the Eastern District of Pennsylvania into the company's marketing

and promotion of Zyprexa and Prozac in that state. That investigation was

initiated in March 2004.

In another turn of events in June, Lilly agreed to pay $690 million to settle

lawsuits filed by approximately 8,000 Zyprexa patients who alleged they had not

been warned the drug might increase the risk of diabetes.

" More than 2,500 other claimants refused to participate in the settlement,

presumably in the belief that the amount received by each claimant, $62,500 on

average, was insufficient compensation for the pain and suffering Zyprexa caused

them, " according to Leonard Roy , author of Zyprexa: A Prescription for

Diabetes, Disease and Early Death, August 2005 edition of Street Spirit.

One of the litigants, Ellen Liversridge, who's son died at age 39 allegedly due

to the adverse affects of Zyprexa, states, " both the FDA and Lilly fought

putting a warning on the label, but thorough articles on the front pages of the

Baltimore Sun, Wall Street Journal, and new York Times so embarrassed the FDA

that they finally gave in to warnings. "

" Rob was a peaceful, funny, brilliant man who battled manic depression with

grace and dignity, " said his mother, " he deserved the best. "

She tells how her son " gained almost 100 pounds on Zyprexa, back before there

was a warning on the label. "

" Rob felt " funny " one Sunday morning, " Ellen relates, " but his symptoms weren't

psychiatric and, to my sorrow, I didn't take him to the ER. "

" By Tuesday, " she said, " he had fallen into a coma from which he never came

out. " Rob remained in a coma for four days and " died Saturday, October 5, 2002,

of profound hyperglycemia. "

" Rob didn't deserve to be killed by a drug carrying a lethal bomb that we knew

nothing about " Ellen said, " He didn't deserve to become another Eli Lilly

statistic. "

" And we, his family, don't deserve to carry the pain that never goes away, " she

added.

Ellen will be the August 24 Washington, DC, protest, " I have a strong sense of

justice as well as retribution, " she said, " I plan to use these things in

whatever way I can, in his memory. "

Deceptive Marketing & Promotion

Award winning journalist Whitaker, author of Mad in America, investigated

the industry's marketing strategy of the atypicals and found biased reviews and

deceptive reporting to be prominent in the promotion of the drugs. Via the

Freedom of Information Act he gained access to FDA raw data on the drug trials

and learned that the FDA's review of the trials did not support industry claims

that the atypicals were safer or more effective than existing generic drugs.

Marcia Angell is a senior lecturer in Social Medicine at Harvard Medical School.

She is also a physician, former editor in chief of The New England Journal of

Medicine and the author of the book, The Truth About the Drug Companies.

According to Marcia the industry is " primarily a marketing machine " to sell

drugs of dubious benefit and uses its wealth and power to co-opt every

institution that might stand in its way, including Congress, the FDA, academic

medical centers, and the medical profession itself. Most of its marketing

efforts are focused on influencing doctors, since they must write the

prescriptions. "

And its obviously working. A study released in August 2004, noted that 41

percent of prescriptions for 765,423 people over age 65 were for psychotropic

medications. (L Curtis et al, Archives of Internal Medicine, Vol 164, pp

1621-1625, 2004). Even though a recent analysis by the FDA noted that elderly

patients using Zyprexa had " a higher chance for death than patients who did not

take the medicine, " and older persons have suffered strokes when taking

Risperdal.

A May 2004 report by The New York Times explained how drug companies were using

new strategies to capture the Medicaid and Medicare markets that involved a

" focus on a much smaller group of customers: state officials who oversee

treatment for many people with serious mental illness. Those patients-in mental

hospitals, at mental health clinics and on Medicaid-make states among the

largest buyers of anti-psychotic drugs. "

Prime examples of this trend, include Ohio Mental Health Director Hogan

and California Director Mayberg. Both control mental health services in

their respective states, and both are members of a Janssen advisory board.

Hogan has proven to be so useful that Eli Lilly has given him a " Lifetime

Achievement Award. " In granting the award it was noted that Hogan had given over

75 presentations at conferences and according to ace records researcher Sue

Weibert, every conference she tracked down that featured Hogan, was sponsored by

drug companies, and the group that organized the conference solicited money from

pharma to pay the keynote speaker.

The particular scheme has become so blatant, that it is finally being

investigated. On June 10, Senators Chuck Grassley and Max Baucus issued a press

release that said they have asked a number of large drugmakers to explain a

marketing practice where the companies give money to state governments and other

organizations in the form of grants.

A request was sent to the following drugmakers: Pfizer, GlaxoKline,

& , Merck & Co, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb,

Novartis Pharmaceuticals, Amgen, Wyeth Pharmaceuticals, Eli Lilly, Sanofi

Aventis, Eisai, Boehringer Ingelheim Pharmaceuticals, Schering-Plough

Corporation, Hoffman-LaRoche, Forest Pharmaceuticals, Abbott Laboratories,

Genentech, Biogen Idec, Genzyme Corporation, Chiron Corporation, Serono, and TAP

Pharmaceutical Products.

The senators said their inquiry is based on reports that some companies have

awarded these grants to health care providers as inducements to prescribe

medications the companies produce. In other cases, such grants to state agencies

may have prompted those agencies to develop programs leading to overmedication

of patients at the expense of patient health or to unnecessary expense for

taxpayers.

" We need to know how this behind-the-scenes funneling of money is influencing

decision makers, " Grassley said, " The decisions result in the government

spending billions of dollars on drugs. The tactics look aggressive, and the

response on behalf of the public needs to be just as vigorous. "

In addition to influencing and corrupting state officials, drugmakers have

infiltrated the nation's health care facilities and gained influence over

prescribing physicians who engage in the practice of overmedicating patients.

For instance, they have set up schemes to funnel profits through senior citizens

in nursing homes. Researcher have found that 75 percent of long-term care

elderly residents receive psychotropic medications. (D Fisk et al) Archives of

Internal Medicine, Vol 163, pp 2716-2724, 2003).

Child advocates say kids are being overmedicated in state run foster care

systems. The children go into the system neurologically normal but leave

neurologically damaged. Austin psychologist and author, Breeding said,

" Children are not just placed on one drug. Typically, they're placed on two or

three or we've seen literally up to 17 different drugs for the same child in

foster care. "

In 2001, the Miami Herald published a series of stories about the common use of

Risperdal among children in state care. Child-welfare advocates said the drug

routinely was being used by foster care providers.

In April 2001, Broward lawyer and child advocate told the Florida

Department of Children & Families administrators that a large number of children

in foster care were being given Risperdal-an antipsychotic drug a UCLA child

psychiatrist describes as among the ``big guns'' of psychiatric medications.

At that time, Florida officials confirmed that thousands of children, including

toddlers, were being prescribed psychiatric drugs, from Ritalin to powerful

drugs like Risperdal and Haldol.

''I had clients who were displaying severe side effects, and I tried to alert

the Department of Children & Families both as to the local problem and the

growing national concern about a range of psychotropic medications, Risperdal

and other antipsychotics in particular,'' said Coral Springs attorney and

children's advocate .

A prime example of bribing doctors in state institutions was unearthed in

Massachusetts, where doctors were found to have changed the medication of four

patients for non-medical reasons. A Boston Globe article published on November

10, 2003, reported that the patients were switched to the atypical Risperdal,

without consent or medical necessity, to make them eligible for a drug trial

sponsored by drug company Janssen, maker of Risperdal.

When other staff members complained, a state agency investigated the matter and

the drug trial was stopped. All state hospital doctors were required to undergo

recertification in the ethics of medical research and the facility's director,

Dr , resigned after it was revealed that he had received $30,000

in speaker's fees from Janssen in 2003.

The current prices for a month's supply of the top three antipsychotics are:

Risperdal $342; Seroquel $414; and Zyprexa $572

Because these drugs are the most expensive on the market, and are so often paid

for by the government, the rampant overprescribing of these medications is

bankrupting state Medicaid programs all over the country. (for reports on

Massachusetts, Florida, Texas, Illinois, and more information go to

www.ahrp.org<http://www.ahrp.org/>)

According to the May 8, issue of Lab Business Week, a new analysis by the US

Substance Abuse and Mental Health Services Administration reveals that Medicaid

is now the largest single payer of mental health services, exceeding private

insurance, Medicare, or other state and local spending. The report notes that

one out of every $5 spent on mental health care now goes for psychotropic drugs.

Pennsylvania Under Fire

In addition to an investigation by the US attorney for the Eastern District of

Pennsylvania into Eil Lilly's marketing and promotion of Zyprexa and Prozac in

that state, two former state investigators are diligently working to expose the

industry's corruption of state institutions.

According to former investigator turned whistleblower, Allan , Pennsylvania

taxpayers are saddled with an expensive drug treatment model known as PennMap,

for the treatment of mentally ill persons in state care.

" This model is part of a large pharmaceutical marketing scheme designed to

infiltrate public institutions and influence treatment practices, " he explained.

" Pennsylvania is paying tens of millions of dollars for patented drugs that have

no proven advantage over cheaper generic drugs. "

As part of the overall scheme, on July 27, 2001, Tom Ridge appointed Gerald

Radke, an Eli Lilly marketing director, to head the Pennsylvania Office of

Mental Health and Substance Abuse. With Radke at the helm, Pennsylvania

Medicaid-funded sales of Lilly's Zyprexa rose from approximately $26.5 million

in 2000 to $34.2 million in 2001, and reached $39.2 million in 2003. In state

hospitals, hundreds of patients had their medications switched in the absence of

medical need or indication, to comply with administrative decisions.

In 2003, there was a total of $139 million in public spending on just two

classes of drugs, SSRI (selective serotonin reuptake inhibitor) antidepressants

and atypical antipsychotics. " A large portion of these dollars were spent to

maintain children on these drugs, " reports, " despite the fact that they

have not been proven effective in children and the FDA has not approved them for

use in children. "

" 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, " said. " The actual numbers may reflect a much higher death

rate, " he added.

On July 1, 2004, another former Pennsylvania investigator, Dr Stefan Kruszewski,

a Harvard psychiatrist/screenwriter-turned-activist, from burg,

Pennsylvania, filed suit against six major pharmaceutical companies after

discovering that commonwealth's children and adults were being abused and

defiled by excessive psychiatric drugs and hazardous psychiatric inpatient

environments.

People are being drugged for profit in Pennsylvania state institutions. While

PennMap was being implemented, Stefan was a psychiatric consultant for the

Department of Health and Human Services, in charge of the mental health

programs, and found that some patients were on as many as five neuroleptic

psychiatric drugs at the same time.

Stefan also discovered corrupt financial relationships between Pennsylvania

politicians and pharmaceutical representatives, fraudulent medication billings

to the government, and that four children and one adult died while under the

state's care, after they were prescribed lethal combinations of anti-psychotic

drugs under the PennMap model.

According to Stefan, the new generation of antipsychotics substantially increase

the risk of obesity, diabetes type II, hypertension, cardiovascular

complications, heart attacks and stroke. The drugmakers had this information and

" simply ignored the problem, " he said.

" So, what we have now is a drug, Zyprexa, whose massive revenues and promotion

are based upon faulty disclosures by the manufacturer, Eli Lilly, " Stefan said.

" The drug causes both a severe metabolic syndrome and cardiovascular problems at

the same time that it continues to cause neurological side effects like its

older 'typical' antipsychotics. "

It does have a decided advantage for Lilly, Stefan contends, " It is far more

expensive, dose per dose, than a comparable 'generic' antipsychotic. " A dose of

haloperidol might sell for 6 pennies while Zyprexa might sell for over $6 per

pill, he said.

Stefan, is also board certified in adult, adolescent, geriatric and addiction

psychiatry, and he and will both be attending the Washington

protest.

Unreported Trials and Studies

Based on the results of a six-week clinical trial sponsored by Lilly, the FDA

granted the company approval to manufacture and distribute Zyprexa in September

of 1996 for the treatment of adult schizophrenics. The trial leading up to

approval involved 2,500 people, and two-thirds of the participants didn't even

complete the trial.

Among those who stuck it out, 22 percent of the Zyprexa subjects suffered a

" serious " adverse effect, compared to 18 percent in the group taking Haldol,

according to Leonard Roy , author of Zyprexa: A Prescription for Diabetes,

Disease and Early Death, August 2005 Edition of Street Spirit.

That same year, FDA data obtained by Whitaker, under the Freedom of

Information Act, revealed Zyprexa's adverse effects to include: cardiac

abnormalities and hypotension, 10 percent to 15 percent; Parkinson-like motor

impairment, 11.7 percent; unbearable restlessness (akathisia), 7.3 percent; and

acute weight gain, 50 percent, increasing the risk of diabetes.

The data also disclosed a participant drop-out rate during six-week clinical

trials of 65 percent. In a one year trial, the drop out rate rose to 83 percent.

FDA reviewers found an average weight gain of almost one pound a week for

subjects during the six-week trial, and a 26-pound increase for Zyprexa patients

who remained in the trial for a year. Other side effects included shaking,

spasms, sedation, diabetic complications, rapid heartbeat, restlessness,

constipation, seizures, liver problems, white blood cell disorders, decreased

blood pressure; and neuroleptic malignant syndrome, which is potentially fatal.

There were also 20 deaths, including 12 suicides, in the Zyprexa group.

" Shockingly, these deaths went unreported in the scientific literature, " Leonard

said. " The death cover-ups also took place in reporting trial results of

several other atypicals during the 1990s. "

In his book, Mad In America, Whitaker, reported that one in every 145

subjects who entered the trials for Zyprexa, Risperdal, Seroquel, and Serdolect

had died.

Despite these severe known side effects, children between the ages of 6 to 11

were recruited for a clinical trial conducted at the University of California

Los Angeles soon after Zyprexa was approved for adults. The children were not

schizophrenic, but were diagnosed with other disorders. According to the

published report on the research, all of the children experienced adverse

effects and none were helped. The study was terminated less than six weeks after

it began. Yet to this day, doctors continue to regularly prescribe atypicals to

children, even though they have never been FDA approved for treatment of any

illness in children.

In 2002, P Murali Doraiswamy, the chief of biological psychiatry at Duke

University, conducted a review of adverse events reported to the FDA by Zyprexa

patients and found:

Of the 289 cases of diabetes linked to Zyprexa, 225 were newly diagnosed cases.

One hundred patients developed ketosis (a 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 adolescent who died of necrotizing pancreatitis (Pharmacotherapy,

July 2002).

Persons on atypicals have been found to commit suicide at rates two to five

times more frequently than schizophrenics in general. According to 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 interview this month with Street Spirit, he 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.

It doubles! It didn't reduce harm. In fact, in their seven-year study, 25 of the

72 patients died. "

The industry routinely hides negative results of studies. " We do not know the

results of the clinical trials they sponsor-only those they choose to make

public, which tend to be the most favorable findings, " Marcia Angell advises.

The problem with the FDA is the fact that it is practically owned by the

industry that it is supposed to regulate. In recent years, nearly half of the

agency's $400 million annual budget has been paid for by drug companies. This

arrangement stems from a 1992 agreement, made partly at the urging of AIDS

activists, that the FDA would speed up approvals in exchange for " user fees "

from industry, according to the May-June 2005 issue of Mother Magazine.

According to the September 9, 2004, Washington Post, because of the industry's

pattern of hiding research that shows adverse affects, medical journals are

taking matters into their own hands. The Post reported that a dozen editors of

prestigious medical journals jointly announced they will refuse to publish drug

research sponsored by pharmaceutical companies unless the studies are registered

in a public database from the outset-a step designed to ferret out unpublished

studies that find medications to be ineffective or dangerous.

The initiative creates a potent incentive for companies to register their drug

trials and is expected to give physicians and the public a window on unfavorable

studies that companies routinely suppress, the Post wrote. The new requirement

calls on companies to register their trials well before anyone knows whether a

study will turn out positive.

The Journal of the American Medical Association, the ls of Internal

Medicine, the Lancet, the New England Journal of Medicine and several other

international publications have signed on to the initiative, and their editors

hope that more will join in, the Wall Street Journal reported.

Activists who will be attending a three-day protest in Washington this month,

beginning August 24, have one thing in common. They want to raise awareness of

the fact that the pharmaceutical industry has allegedly injured Americans with

dangerous products to increase profits and the nation's regulatory agencies have

aided and abetted them.

Pringle is a columnist for Independent Media TV and an investigative

journalist focused on exposing corruption.