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Off-label prescribing of
prescription drugs overall is widespread in the US, but nowhere is it
more prevalent than with the antidepressant drugs known as selective
serotonin reuptake inhibitors. A study in the June 2005, Journal of
Clinical Psychiatry, found that 75% of the prescriptions written for
SSRIs were for treatments not approved by the FDA.
lead author, Dr Hua Chen, an assistant professor at the University of
Houston, said the findings reveal a significant gap in the US drug
safety system and off-label prescribing regularly exposes consumers to
drugs that are untested for their condition.
The FDA approves drugs for uses that have been tested and
proven to be safe and effective. The term off-label means prescribing a
drug for a use not approved or for a different patient population, such
as children instead of adults, or at a different dose or duration than
was determined by the FDA to have a favorable risk-benefit ratio.
doctors may legally prescribe a drug for an off-label use, drug makers
are barred from promoting a drug for unapproved uses, but it is a
widely known that it occurs on a regular basis. For instance, SSRIs are
still being prescribed off-label for a multitude of unapproved
conditions to patient groups that includes children as young as
toddlers, the elderly, and pregnant women.
Over the past 20
years, SSRIs have been prescribed off-label for everything from anxiety
to pain, insomnia, shyness, menstrual discomfort, dementia, restless
leg syndrome, and a host of other invented disorders sold to the public
with the help of industry funded front groups and PR firms.
with the exception of Vioxx, in the end SSRIs will probably hold the
title for not only the most side effects but also for the most lawsuits
filed against SSRI makers due to their conduct of concealing studies
that identified serous adverse events while at the same time
overstating their efficacy, in the name of profits.
of drugs has now been found to be associated with suicidality, extreme
violence and homicide, several life-threatening birth defects, abnormal
uterine or gastrointestinal bleeding, a decrease in bone mineral
density, fertility problems, sexual dysfunction, and a severe
In large part because the SSRI makers have
been ripping off public health care programs by billing the government
for the vast majority of off-label prescriptions, Federal and state law
enforcement agencies are zeroing in on the drug companies and the
doctors who are writing the off-label prescriptions as a result of
kickbacks of some form or another.
The various illegal marketing
schemes are taking their toll on public health care programs. According
to the US Department of Health and Human Services, in 2005, Medicaid
paid $41 billion for prescription drugs, well over 4 times the $8.9
billion spent in 1994.
Several Congressional Committees are
currently investigating the off-label promotion of drugs by the
pharmaceutical industry. While testifying at a US House Committee on
Oversight and Government Reform on February 9, 2007, Lewis Morris,
Chief Counsel at the Department of Health and Human Services' Office of
Inspector General, informed members of Congress about the adverse
effects of prescribing drugs for unapproved uses.
promotion," he said, "may lead physicians to prescribe a product for a
non-approved use based on false, misleading, or erroneous information
to the medical detriment of their patients."
"In addition," Mr
Morris continued, "off-label promotion fundamentally circumvents the
FDA drug approval process, on which Americans rely to evaluate the
safety and efficacy of pharmaceutical products."
warned that physicians may be under the wrong impression that they can
demand "kickbacks from drug companies with impunity," because in the
past prosecutors have focused on the drug makers paying the kickbacks.
in cracking down on doctors, Mr Morris told the Committee that the OIG
plans to use its authority to impose monetary penalties and the
exclusion of doctors from public health care programs who are found to
be accepting kickbacks.
Ronald Tenpas, associate deputy
attorney general in the Department of Justice, testified about the harm
caused by the corruption of doctors on the public as a whole. "By
inducing physicians to prescribe for uses that have not been approved,"
he said, "either by promoting compromised "science" or offering
financial incentives, manufacturers are subverting a healthcare system
that necessarily relies on the objective medical judgment of
practitioners, and their actions may also harm the public health."
is clear," Mr Tenpas said, "from our experience that drug company
violations of the law are causing government health-care programs to
pay too much for prescription drugs."
"We are not seeing
isolated instances of misconduct," he told the panel, "but repeated
practices within the industry that have resulted in significant loses
to federal health-care programs."
The majority of lawsuits
against drug companies alleging illegal marketing schemes aimed at
public health care programs were filed under the provisions of the
Federal False Claims Act, which allows persons who find evidence of
fraud to bring suit on behalf of the government and collect a
percentage of the amount recovered.
These whistleblower cases
are first filed under seal until the DOJ investigates the charges and
decides whether to intervene. Over the past six years, the government
has recovered close to $4 billion in 16 cases involving Medicaid with
Pfizer paying the highest penalty of $430 million for the off-label
marketing of the epilepsy drug Neurontin.
The list of side
effects associated with SSRIs that have surfaced over the past 2
decades continues to grow every year. But ironically, the drug
companies have been so adept at keeping negative information about
SSRIs hidden that most of the side effects only come to light as a
result of litigation.
All SSRI makers have lawsuits pending
involving a variety of adverse events. For example, in June 14, 2006,
SEC filings, Lexapro and Celexa maker, Forest Laboratories says the
company is a named defendant in approximately 25 active lawsuits, with
most alleging that Lexapro or Celexa contributed to persons committing
or attempting suicide.
In addition, Forest is under
investigation by the US Attorney's Office for the District of
Massachusetts to determine whether Forest committed civil and criminal
violations of the Anti-Kickback laws related to the off-label marketing
of Celexa and Lexapro.
However, legal experts say drug companies
view lawsuits as a minor problem and chock them up to the cost of doing
business. For instance, what are 25 lawsuits to Forest, when Celexa and
Lexapro, accounted for 68% of the company's sales last year. In fact,
Lexapro revenues were 16% higher in the 4th quarter at $464,100,000,
compared to $399,381,000 in the same quarter the year before.
Badyna has a Lexapro-induced suicide lawsuit pending in New Jersey
filed on behalf of his deceased son, Ray Badyna's estate, by attorneys,
Derek Braslow and Harris Pogust, of the Pogust & Braslow, LLC firm,
in Conshohocken, Pennsylvania.
Ray's suicide was totally
unexpected. His friends and family members say there is no logical
explanation for it other then the effect of Lexapro. On October 7,
2003, Ray received great news that for the second year in a row, his
job performance for the year had qualified him to receive the,
"Countrywide Circle of Excellence Award."
And yet two days later
at age 32, he committed suicide. "Had Ray or his physician known of the
increased risk of suicide and suicidal ideation from Lexapro," the
lawsuit states, "Ray would have never taken the drug."
Ray said nothing to his family that would indicate he planned to kill
himself, after his death, it became known that Ray had expressed
thoughts about harming himself to other people. In one conversation
with a friend, Ray complained that Lexapro was making him "feel weird"
and he "had very strange thoughts running through his mind."
Braslow explains that SSRIs are designed to alter serotonin levels in
the brain. "For years," he reports, "it has been known that serotonin
functioning is directly related to aggression and violence, both
directed at oneself and at others."
"Unfortunately," he states,
"there is a vulnerable population of patients who are at an increased
risk of violence and suicide as a result of taking Celexa, Lexapro and
other SSRI drugs."
According to Attorney Pogust, the SSRI
manufacturers have known about this population of high-risk patients
for many years. "And, yet," he says, "these companies have failed to
conduct any tests to determine the frequency of this phenomenon or to
develop ways of identifying and protecting those patients who are in
the high risk group."
As far back as November 1991, Dr John
Mann, who now regularly serves as an expert witness for SSRI makers,
coauthored an article titled, "The emergence of suicidal ideation and
behavior during antidepressant pharmacotherapy," in the Archives of
General Psychiatry in which he discussed the phenomenon of "iatrogenic
suicide," also known as physician-induced suicide, and warned that
there may be a "small vulnerable subpopulation" of patients for whom
SSRIs pose a risk of suicide or violence.
In the paper, Dr
Mann took it a step further and suggested protocols for studies that
could be used to test this hypothesis and the drug companies
deliberately did not conduct the research because they knew it would
confirm Dr Mann's findings and a warning of such serious adverse events
on the labels of SSRIs would have had a negative impact on sales.
worst of all," Mr Braslow says, "is that the SSRI manufacturers failed
to warn prescribing physicians about the suicide risk or to instruct
them on ways to reduce the risk."
Lexapro did not help Ray's
condition and in 20/20 hindsight, his family recalls that after he
began taking the drug, Ray immediately began to deteriorate. They
maintain that had they been instructed to watch for signs of
suicidality, Ray would still be alive.
Although it is largely
unknown to the public, over the past 15 years, hundreds of SSRI-related
lawsuits have been quietly settled out of court. The drug companies
have gone to great lengths to avoid jury trials in order to keep the
particulars of the lawsuits and the health risks associated with SSRIs
hidden from public view.
However, in recent years, the filing
of lawsuits has picked up speed as more people become aware of the link
between SSRIs and serious side effects, usually as a result of media
attention focused on information uncovered in litigation. More often
than not, the information verifies that the drug companies
intentionally concealed their own negative studies showing the health
risks associated with SSRI and their lack of efficacy.
evaluation that surfaced as a result of litigation on the spontaneous
post-marketing reports of "hostility" and "intentional injury" by
people on Prozac, generated shortly before a 1991 FDA advisory
committee meeting, compared SSRI suicidality to the antidepressant,
trazodone, and found a 20-fold increase in reports of hostility and
intentional injury in patients on Prozac.
The lawsuit filed on
behalf of Ray Badyna, specifically cites an article published in 2000,
on a study funded in part by Prozac maker Eli Lilly, and Paxil maker
SmithKlineBeecham, that found the incident of deliberate self-harm by
patients taking SSRIs to be 5.5 times higher than persons taking
Recently a document became public
that clearly shows the manipulation of study results in articles
published on Pfizer's Zoloft (sertraline), by the medical
communications agency, Current Medical Directions in 1998.
CMD published 6 articles on Zoloft use with children but all total,
only 1 article mentions one suicidal act. However, according to Dr
David Healy, one of the world's leading authorities on SSRIs, and
author of "Let Them Eat Prozac," and "The Antidepressant Era," there
were 6 suicidal acts.
He says, the rate of suicidality in
children taking Zoloft was in fact 9%, but Pfizer got away with not
publishing these negative findings by only reporting side effects that
occurred at a rate of 10% or higher.
As far as the benefits of
Zoloft, a study in the Journal of American Medical Association in April
2002, compared the effectiveness of Zoloft, St John's Wort, and a
placebo and reported that placebo patients had the highest rate of
remission of symptoms at 31.9%, and Zoloft's 24.8% rate of remission
was barely better than the 23.9% of St John's Wort.
of suicides that experts say are SSRI-induced are extremely violent,
totally unexpected and impulsive. Notes are seldom left and many
suicide attempt survivors recall a strange out of body like experience.
For instance, 71-year-old Milton Cole, who was in good health
and not depressed, went to a heart doctor with chest pains. After tests
failed to reveal a heart problem, the doctor gave Mr Cole free samples
of Prozac, supposedly to relieve the chest pain. Thirteen days later,
his wife found him hanging from a beam in a back room of their shop,
according to the November 3, 2003 Miami Herald.
Glenmullen, author of "Prozac Backlash," and "The Antidepressant
Solution," explains that the difference between ordinary suicidality
and SSRI induced suicidality can be distinguished because an activation
syndrome usually accompanies SSRI suicidality, which includes akathisia
Harvard trained psychiatrist, Dr Stefan Kruszewski,
agrees and says, "Because the drugs cause predictable neurochemical
changes in the central nervous system, SSRIs can also increase the risk
of violence and aggressive acting out."
On March 22, 2004, the
FDA issued an Advisory warning that symptoms such as akathisia,
anxiety, agitation, panic attacks, insomnia, irritability, hostility,
impulsivity, hypomania, and mania had been reported in patients taking
Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor,
Serzone and Remeron and recommended close observation of patients for
worsening depression or emergence of suicidality.
Attorney Braslow, at the time of this warning it was revealed that
Forest had added a suicide warning on Celexa sold in Europe years
earlier, but in the US there was no such warning on Lexapro or Celexa.
addition," Mr Pogust reports, "the drug maker had previously conducted
a number of European trials with both hospitalized and outpatient
adolescents which showed Celexa to be no more effective than a placebo."
May 2005, the FDA published the alarming suicide rate for children
taking SSRIs in a Public Health Alert that stated "1 in 50" kids on
SSRIs become suicidal or have increased suicidality "DUE TO DRUG."
next month, another FDA Advisory warned that adult patients "should be
watched closely for worsening of depression and for increased suicidal
thinking or behavior."
In addition to suicide, some of the most
serious adverse events reported to be associated with SSRIs in recent
years, are birth defects. Many studies have determined that SSRIs are
harmful to the unborn fetus. In April 2006, a study in the American
Journal of Obstetrics and Gynaecology, by Canadian researchers, found
that SSRIs use during pregnancy doubled the mother's risk of delivering
a stillborn infant and increased the risk of premature delivery,
underweight babies, and seizures.
These findings are important
for doctors to know because according to a report by CDC researchers
last year in Pediatrics, preterm birth is the leading cause of infant
mortality in the US, accounting for at least a third of all deaths in
The harms to the fetus reported include a withdrawal
syndrome, requiring prolonged hospital stays, respiratory support and
tube feeding and a 6-fold increase in the life-threatening lung
disorder, persistent pulmonary hypertension, as well as serious heart
birth defects that require open heart surgery to correct.
September 2005, studies conducted by Danish and US researchers found
that the use of SSRIs in the first 3 months of pregnancy was linked to
a 40% increased risk of birth defects such as cleft palate, and a 60%
increase in cardiac defects. One study of 1,054 women who took SSRIs
found they increased the risk of premature birth by 40%.
result of the rising number birth defects found to be associated with
SSRIs, drug companies are facing a slew of lawsuits. They are
reportedly especially worried about birth defect information becoming
public because medical experts estimate that tens of thousands of
infants in the US have SSRI-related birth defects, with the blame
largely unknown to the parents.
Nearly 10 years ago, one of
the harshest admonishments about the over-prescribing of SSRIs came in
an Editorial in the October 20, 1997, issue of Time Magazine by Candace
Pert, a professor at Georgetown University Medical Center at the time,
as one of the two scientists who discovered the serotonin binding
process, which stated in part:
I am alarmed at the monster that
Johns Hopkins neuroscientist Solomon Snyder and I created when we
discovered the simple binding assay for drug receptors 25 years ago.
and other antidepressant serotonin-receptor-active compounds may also
cause cardiovascular problems in some susceptible people after
long-term use, which has become common practice despite the lack of
The public is being misinformed about the
precision of these selective serotonin-uptake inhibitors when the
medical profession oversimplifies their action in the brain and ignores
the body as if it exists merely to carry the head around!
"In short," she warned, "these molecules of emotion regulate every aspect of our physiology."
Healy says SSRIs continue to be over-prescribed even as researchers are
finding more and more adverse events and doctors need to fully explain
these side effects before prescribing the drugs so patients can make an
informed choice about taking them.
Persons seeking more
information on cases involving Celexa related suicides can contact the
Pogust & Braslow law firm at 610-941-4204, or http://www.pogustbraslow.com/
article is part of a series covering litigation involving the
pharmaceutical industry and is sponsored by the Pogust & Braslow,
LLC law firm)
Evelyn Pringle is a columnist for OpEd
News and investigative journalist focused on exposing corruption in
government and corporate America.
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