[SSRI-Research] Psych Drugs — Doctors Serve As Middle-Man
Sierra Times, Wed, 22 Feb 2006 1:45 AM PST
Psych Drugs — Doctors Serve As Middle-Man Pushers
Evelyn Pringle
Although peddling psychiatric drugs for off-label treatment of every
ailment known to man is highly profitable, it is also illegal.
Marketing schemes that increase the rates at which drugs are
prescribed for off-label use, result in the sale of drugs that have
not been proven safer or superior to FDA approved medications already
on the market.
That said, its time to quit blaming the pharmaceutical industry
exclusively for off-labeling marketing. The fact remains, that drug
makers could not sell their new and relatively untested drugs if not
for the doctors who take on the role of middle-man pusher.
Since the arrival of selective serotonin reuptake inhibitors
antidepressants (SSRIs), and atypical antipsychotics on the market,
countless studies have shown the so-called "new generation" of
psychiatric drugs to be ineffective and dangerous. But for years, drug
companies have successfully manipulated data, suppressed negative
studies, and reported only the clinical trials with positive results.
However, by now plenty of warnings have been issued about these drugs,
and doctors who continue to prescribe them due to financial incentives
from pharma, or because they happen to be approved by the compromised
FDA, should not be let off the hook. If it takes a few highly
publicized lawsuits against prescribing physicians to knock some sense
into these doctors, so be it.
Medical professionals need to start conducting their own research
which means doing more than relying on medical journal abstracts on
the internet that for the most part, are formatted to report
misleading claims without mentioning the contradictory data.
On January 13, 2005 WebMD Medical News reported a government study
that showed more Americans than ever are being treated for substance
abuse, depression, and other mental health disorders, but the
treatment they are getting is increasingly limited to prescription
drugs alone.
The study assessed changing patterns in the treatment of mental
illnesses from the mid-1990s to 2001, and determined that mental
health drug costs rose 20% each year.
According to Economist Samuel H Zuvekas, PhD, who conducted the
analysis, about 80% of the growth in expenditures can be explained by
the increase in the use of SSRIs and other antidepressants, and
high-priced schizophrenia drugs called "atypical antipsychotics."
Worldwide, sales of anti-psychotics went from $263 million in 1986 to
$8.6 billion in 2004 and antidepressant sales went from $240 million
in 1986, to $11.2 billion in 2004, For these two classes of drugs
combined, sales went from $500 million in 1986 to nearly $20 billion
in 2004, a 40-fold increase, according to Robert Whitaker,
best-selling author of Mad in America.
For over 15 years, millions of Americans have been prescribed SSRIs
for off-label treatment of a multitude of newly invented disorders. Mr
Whitaker says, "what we’re seeing is nothing more than the creation of
a larger market for drugs."
"If you think about it," he explained during an August 2005, interview
with Street Spirit, "as long as we draw as big a circle as possible,
and expand the boundaries of mental illness, psychiatry can have more
clients and sell more drugs."
"So there’s a built-in economic incentive to define mental illness in
as broad terms as possible," he continued, "and to find ordinary,
distressing emotions or behaviors that some people may not like and
label them as mental illness."
Prozac is the only SSRI approved by the FDA for treating depression in
children. It is reportedly the only SSRI shown to be effective in two
pediatric trials, the number required to obtain FDA approval.
But to put the term "effective" into perspective, all a drug has to do
to pass 2 trials, is show it had better results in children treated
with the SSRI than children taking a placebo. The trick is that a
company can do 100 trials to get the necessary result if need be. It
stands to reason that sooner or later the SSRI is bound to do better
than a placebo when the odds are 50-50.
However, over the past couple of years, this practice has been coming
under scrutiny. GlaxoSmithKline was nailed for fraud in 2004, by New
York State Attorney General, Eliot Spitzer for hiding studies that
"not only failed to show any benefit for the drug in children but
demonstrated that children taking Paxil were more likely to become
suicidal than those taking a placebo."
The suit said the company had conducted at least 5 studies on the use
of Paxil on children, but only published and disseminated the results
of one.
Spitzer drew attention to the fraud charges by publishing a 1998
e-mail in which Glaxo officials discussed the studies and the need to
"effectively manage the dissemination of these data in order to
minimize any potential negative commercial impact."
Although Paxil was never approved to treat depression in children,
according to Spitzer, in 2002, doctors prescribed the drug off-label
to children two million times, the same year that Paxil was Glaxo’s
top seller, with sales of $3.8 billion.
To settle the charges, Glaxo agreed to pay $2.5 million to the State
of New York.
An April 10, 2004 article in the British Medical Journal, citing
Jurendi et al, criticized the authors of published studies on SSRIs
for exaggerating benefits and downplaying their harm. As an example,
Jurendi noted that a trial of 93 kids on Paxil, produced 11 serious
adverse events compared with only two in the placebo group. Despite
this, and the fact that 7 of the Paxil patients were admitted to the
hospital, the authors of the study claimed Paxil "was generally well
tolerated in this adolescent population, and most adverse effects were
not serious."
As for the effectiveness of SSRIs, in June, 2005, the Washington Post
reported: "Despite a dramatic increase in treatment of psychiatric
disorders during the past 10 years, there has been no decrease in the
rate of suicidal thoughts and behavior among adults, according to a
federal study primarily funded by the National Institute of Mental
Health."
Although studies have shown atypical antipsychotics to be associated
with a growing number of serious adverse effects, doctors continue to
be prescribe them off-label to teat a host of health problems, for
senior citizens, persons in state institutions, and children.
In 2004, atypicals became the fourth-highest-grossing drugs in the US,
with $3.4 billion of their total sales funded by state Medicaid
programs, according to the article Medicating Aliah, in the May 2005
issue of Mother Jones Magazine.
Recent research has shown that nursing home residents are being fed
antipsychotics in record numbers. A June 13, 2005, study published in
the Archives of Internal Medicine examined the quality of
antipsychotic prescriptions in approximately 2.5 million Medicaid
beneficiaries in nursing homes and found that "over half (58.2%),"
received antipsychotic drugs that exceeded the maximum recommended
dosage, received duplicate therapy, or under the guidelines, had
inappropriate indications for the medications to begin with.
The study found that more than 200,000 nursing home residents received
antipsychotic therapy but had "no appropriate indications for use."
Pharma will stop at nothing when it comes to making money off
children. On April 25, 2005, the Ohio Columbus Dispatch reported an
investigation of state Medicaid records that found 18 newborn to 3
years-old babies in Ohio had been prescribed antipsychotic drugs in
July 2004.
During an investigation of children under state care in Pennsylvania,
Dr Stefan Kruszewski, a Harvard trained psychiatrist, found "cases
where children were placed in state-funded residential treatment
facilities, sometimes for years, and were heavily drugged with the new
antipsychotics and anticonvulsants."
Reports of the adverse effects of the drugs on children are beginning
to emerge. The Children’s Hospital of Philadelphia recently found that
19% of newly diagnosed Type 2 diabetic children were being treated
with psychiatric drugs like Zyprexa, Risperdal, Geodon, Seroquel,
Clozaril, and Abilify, according to Robert F. Kennedy Jr vs the
Medical Elite, by Mark Sircus Ac, OMD in June 22, 2005.
"Many of these drugs carry black box warning to alert MD’s about the
dangers of diabetes," Mr Sircus pointed out. "The most studied adverse
effect of the newer generation of antipsychotics is their association
with hyperglycemia, in some cases leading to ketoacidosis, coma, or
death," he wrote.
According to Dr Kruszewski, the new atypicals substantially increase
the risk of obesity, diabetes type II, hypertension, heart attacks,
cardiovascular complications, and stroke.
"The drug makers had this information and simply ignored the problem,"
he says.
Dr Kruszewski is apparently correct judging by hidden studies that
have come to light. After years of prescribing Risperdal, for
off-label use by millions of patients in all age groups, on July 24,
2004, the Miami Herald reported the "maker of a billion-dollar
antipsychotic medication has acknowledged misleading doctors and other
healthcare providers about the safety of its product, minimizing
potentially deadly side effects."
As it turns out, the maker of Risperdal, had 2 billion good reasons to
hide the dangers associated with the drug because Janssen earns about
$2.1 billion in annual sales from Risperda, according to the Miami
Herald.
During his interview with Street Spirit, Mr Whitaker summed up the
devastating effects on society as a result of the marketing practices
promoting the sale of the new psych drugs:
"Unfortunately, the cost is dishonesty in our scientific literature,
the corruption of the FDA, and the absolute harm done to children in
this country drawn into this system, and an increase of 150,000 newly
disabled people every year in the United States for the last 17
years," he said. "That’s an incredible record of harm done."
But worst of all, Mr Whitaker says: "No one says that the mental
health of the American people is getting better."
For information for injured parties go to Lawyers and Settlements
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