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Patients Diagnosed Schizophrenic and Bipolar To Boost Seroquel Sales
Washington, DC: For over a decade,
drug makers have been influencing doctors to diagnose patients,
especially those covered by public health care programs like Medicare
and Medicaid, with mental illnesses to justify the over-prescribing of
the new class of drugs known as "atypical" antipsychotics.
For instance, Seroquel, marketed by AstraZeneca, is only
FDA approved to treat acute manic episodes associated with bipolar I
disorder and schizophrenia, and yet it is one of the most widely
prescribed drugs in the world.
Astra reports that over 16 million patients have taken Seroquel since
it came on the market in 1997, and the drug had sales of close to three
and a half billion dollars in 2006, according to SEC filings.
Decision Resources, an advisory firm on health care matters, reported
that in 2005, two of the top 10 selling drugs worldwide were atypicals.
A new study by the US Agency for Healthcare Research and Quality, found
that between 1997 and 2004, spending on antipsychotics more than
tripled from $1.3 billion to $4.1 billion and the largest purchasers of
atypicals are public health care programs.
The other drugs in this class include Eli Lilly's Zyprexa,
Bristol-Myers Squibb's Abilify, Johnson & Johnson's Risperdal, and
These drugs were promoted as working better than the old "typical"
antipsychotics in addition to having fewer of the serious side effects
associated with the older drugs. Both of these claims have now been
proven false, but unfortunately tens of millions of people have already
taken the new drugs.
A study funded by the National Institute of Mental Health, entitled the
"Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE),"
compared the atypicals against the older medication, perphenazine and
found the atypicals were no more effective than the older drug although
they cost 10 to 20 times more. By comparison, the cost of perphenazine
was $50 a month, and Zyprexa was $545.
But the results of this $40-odd million dollar tax payer funded study
is not news. Back in December 2000, the British Journal of Psychiatry
reported a review of 52 studies involving 12,649 patients and stated:
"There is no clear evidence that the atypical antipsychotics are more
effective or better tolerated than conventional antipsychotics."
Over the past several years, studies have linked the atypicals to a
number of serious health problems including insulin resistance and
diabetes. According to an October 2006, report by the National
Association of State Mental Health Program Directors, diabetes causes
tissue damage in many organs, is a major cause of vascular disease, and
is the number one cause of adult blindness, end-stage kidney disease
and non-traumatic amputations.
Insulin resistance, the report says, is closely linked to developing
metabolic syndrome, which includes hypertension, high cholesterol,
increased blood clotting and eventually insulin dependent diabetes.
Astra is currently facing nearly 10,000 lawsuits in state and Federal
courts over injuries and deaths caused by Seroquel, and Eli Lilly has
already agreed to pay well over a $1 billion to settle cases
out-of-court with approximately 26,000 Zyprexa victims.
In February 2007, the state of Pennsylvania filed a lawsuit against
AstraZeneca, and other atypical makers, alleging the drug giant
illegally marketed Seroquel off-label for unapproved uses.
The state is demanding reimbursement for the cost of the drug and
medical care provided to patients who developed serious health
conditions while taking the drug. The lawsuit alleges Astra concealed
the risks of Seroquel and exaggerated the benefits while persuading
doctors to prescribe it for uses not FDA approved as safe and
Astra, the complaint alleges, cost Pennsylvania's Medicaid and drug
assistance for the elderly program millions of dollars for "reimbursing
for non-medically accepted indications and non-medically necessary
uses," of Seroquel, as well as "significant sums of money for the care
and treatment" of patients injured by the drug.
Legal experts say millions of people have been duped into taking the
atypicals with massive off-label marketing campaigns based on lies,
distortions, and rigged-for-profit clinical trials.
Attorney, Derek Braslow, of the Conshohocken, Pennsylvania law firm,
Pogust & Braslow, says the schemes usually follow a familiar
pattern. "First," he explains, "the drug maker promotes the drug as
significantly more effective than the current standard of care when in
reality, its effectiveness is questionable."
"Second," he says, "they market the drug to doctors as safer when not
enough studies have been conducted to determine whether it is safe and
perhaps, the studies were designed in a way that would never detect the
risk in the first place."
"Third," Mr Braslow notes, "the companies promote the drug off label for all types of indications and for all age groups."
But prescribing doctors have played a major role in medicating patients
for profit with the new atypicals. Drug companies are prohibited from
promoting a drug for off label uses outside of the FDA-approved
indications because for conditions or patient population not listed on
the label the drug has not been proven safe and effective.
However, through a major legal loophole, doctors have the authority to
decide whether the risk of prescribing a drug for an unapproved use is
justified by the benefits. Which means all companies have to do is
convince doctors, by whatever means, to prescribe a drug for unapproved
uses and deny the drug maker's involvement in their decisions.
Unfortunately, it is the unwitting patients who will endure the stigma
of a life-long label as a result of the atypical drugging for profit
scheme. When people think about schizophrenia or bipolar disorder they
picture patients who hear voices, are delusional, and possibly
dangerous to themselves or others. The people misdiagnosed to boost the
sale of these drugs, including scores of innocent children, will face a
lifetime of suspicion and discrimination by society as a whole.
The Pennsylvania lawsuit says the drug maker influenced doctors to
prescribe Seroquel off-label to children for behavior disorders like
attention-deficit. The atypicals are not approved to treat children for
any condition but a review of records from HMOs and Medicaid programs
by researchers at Vanderbilt University found a dramatic increase in
the use of the drugs with children, particularly for behavioral
disorders, according to the March/April 2006, Journal of Ambulatory
The study found that between 1995 and 2002, there were 5,762,193
outpatient medical visits by children, aged 2 to 18 years old, at which
an antipsychotic was prescribed. The drug companies have doctors in
every field of medicine prescribing atypicals to kids, with 32% of the
almost 6 million prescriptions, written by pediatricians, family
physicians, emergency department doctors, or other types of providers.
The study authors specifically said that there had been no increase in
mental disorders that could justify the prescribing increases "as
recent studies do not suggest significant increases in the incidence of
According the study report, these medications have not been studied at
all for behavioral disorders and yet, the most common diagnosis was
attention deficit disorder or conduct disorder, accounting for 29.0% of
Critics says, the logical question to ask is how would a pediatrician
or family physician, whose practice does not ordinarily include
diagnosing or treating mental disorders, ever come up with the idea to
prescribe Seroquel to a child for any reason without the input from the
As for the benefits of treating kids who are schizophrenic, an August
2006, study by the New York Psychiatric Institute found that the older
drugs work far better. The average response rate in children among 8
studies employing the new antipsychotics was only 55.7%, compared to a
72.3% with children in 13 studies who received the older drugs.
The Pennsylvania lawsuit alleges the drug maker influenced doctors to
prescribe Seroquel off-label for dementia in elderly patients. On April
11, 2005, after a study revealed that elderly patients with dementia
who were taking atypicals were far more likely to die prematurely, the
FDA announced the addition of black box warnings about the increased
risk of death on the labels of atypicals.
A June 13, 2005, study in the Archives of Internal Medicine, reviewed
atypical use by approximately 2.5 million Medicaid patients in nursing
homes and found that over half received medications that exceeded the
highest recommended dose, received duplicate therapy, or had
inappropriate indications for the drugs to begin with. All total, the
study determined that more than 200,000 nursing home residents received
atypicals but had "no appropriate indications for use."
On October 12, 2006, a study in the New England Journal of Medicine
reported that the atypical drugs most commonly used to treat people
with Alzheimer's were no more effective than placebos for most
patients, and caused serious side effects including confusion,
sleepiness and Parkinson's disease like symptoms.
The FDA has acted as an accomplice in allowing atypical makers to
suppress other adverse events found in their own clinical trials.
According to Dr David Healy, a world-renowned expert on psychiatric
drugs, a great deal of data is available on the rates of suicides and
suicidal acts in clinical trials on atypicals. He says Zyprexa probably
has the highest suicide rate in clinical trial history and calls the
absence of available data on suicidal acts and Zyprexa "striking."
By using the Freedom of Information Act to obtain data from the FDA,
award-winning journalist, Robert Whitaker, author of, Mad in America,
reported that one in every 145 patients who participated in the
clinical trials with the atypicals died.
On March 1, 2007, four days after the Pennsylvania lawsuit was filed,
Astra became the target of another investigation, when US House of
Representative, Henry Waxman (D-Cal), chairman of the House Oversight
and Government Reform Committee, sent a letter to Astra, requesting
information related to the exact same charges alleged in lawsuit.
The lawmaker's letter asks for a list of all Seroquel trials, studies,
or reports; all presentations given to employees who promoted Seroquel;
information shown to physicians; presentations related to physician
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.
Critics say the culpability of the doctors in over-prescribing drugs
that cause such serious diseases and adverse events cannot be ignored.
This critic says, labeling people mentally ill for profit, especially
innocent children and the elderly, is an indefensible crime and that
all the monsters that engaged in this 10-year off-label marketing
scheme should be arrested and sent to prison, and the jailer on duty
should throw away the key.
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