Why are atypical drug users angry? - Just another pattern to ingore while we enjoy a holiday

[Guest guest]

Why are atypical drug users angry?

http://onlinejournal.com/health/081905Pringle/081905pringle.html

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.

*

The material in this post is distributed without profit to those

who have expressed a prior interest in receiving the included

information for research and educational purposes.

For more information go to:

http://www4.law.cornell.edu/uscode/17/107.html

<http://oregon.uoregon.edu/%7Ecsundt/documents.htm>

http://oregon.uoregon.edu/~csundt/documents.htm

<http://oregon.uoregon.edu/%7Ecsundt/documents.htm>

If you wish to use copyrighted material from this email for

purposes that go beyond 'fair use', you must obtain permission

from the copyright owner.