Two years ago, we investigated the suicide
of a 7-year-old Florida foster child five years after his death, to
find out whether officially recommended changes to the state's foster
care program had been implemented following the tragedy. Based on
records obtained from the Department of Children and Families (DCF)
spanning the five-year period after the child's suicide, we concluded
nothing had changed. After reviewing the DCF records, psychiatrist
and child advocate Dr. Peter Breggin warned then about the foster
program's ongoing and dangerous practice of psychotropic
polypharmacy: “Whenever you put children on multiple psychiatric
drugs you are creating an experiment that is doomed to do more harm
than good... We need to stop experimenting on America's children.”
We had hoped by
calling attention to the lack of real progress overhauling the Florida foster care program's over-reliance on pills to cure all ills,
further tragedies might be prevented. Mission failed.
Recently, a
14-year-old Florida foster child, prescribed a psychotropic cocktail
similar to the 7-year-old foster child, committed suicide in a nearly
identical manner, only this time streamed live on Facebook.
In 2009, 7-year-old
Gabriel Myers hanged himself in the bathroom of his Florida foster
home. Toxicology
detected amphetamine, fluoxetine and olanzapine in his system.
Medical records indicated psychiatrist Dr. Sohail Punjwani prescribed
young Gabriel 50mg of the ADHD drug Vyvanse (lisdexamfetamine
dimesylate), and 25mg of the antidepressant and antipsychotic
combination drug Symbyax (fluoxetine, olanzapine). Although there
was was no doubt Gabriel died at his own hand, Broward Deputy Chief
Medical Examiner Dr. Stephen Cina did not rule his death a suicide,
stating: “It is unclear whether these drugs contributed to this
fatality or not.” Dr. Cina noted in his report that neither
Symbyax, nor one of its key ingredients olanzapine, also known by the
brand name Zyprexa, was approved for use in children; and that
“fluoxetine [Prozac] and olanzapine can increase the risk of
suicidal ideation in children taking this drug.”
It also came to
light that Gabriel was among Florida foster children being used as
guinea pigs for pharmaceutical clinical trials. After an
investigation into his clinical trial practices, the Food and Drug
Administration (FDA) issued a warning
letter to Dr. Punjwani, citing violations including failure to
protect the rights, safety and welfare of human test subjects; doses
exceeding protocol-specified limits; and failure to follow clinical
trial plans. Through an executive order,
then DCF Secretary George Sheldon instituted a limited prohibition of
the shady practice of conducting drug experiments on Florida's foster
children.
A recent Canadian
study
found youth prescribed ADHD drugs were thirteen times more likely to
be prescribed antipsychotic medications, and almost four times more
likely to be prescribed antidepressant medications than children who
were not prescribed ADHD drugs. The study's authors argued that
children with ADHD have more psychiatric comordibities than children
without ADHD, omitting the exceedingly relevant fact that psychosis
and depression are labeled side effects of ADHD drugs. Clearly, the
possibility eluded the authors that the increased rates of psychosis
and depression observed may not be linked at all to so-called
comorbidities of ADHD, but rather to the drugs prescribed to treat
ADHD.
Indeed, the Vyvanse
label
warns: “Vyvanse at recommended doses may cause psychotic or manic
symptoms even in patients without prior history of psychotic symptoms
or mania.” According to the DSM-5, up to twenty-five percent of
all first episodes of psychosis are substance/medication-induced.
Likewise, the label for the stimulant drug also warns: “Fatigue and
depression usually follow the central nervous system stimulation.”
Research suggests
drug treatment of ADHD unleashes a domino effect, triggering more
psychiatric diagnoses, which in turn lead to risky polypharmacy. The
cascading reactions associated with drug treatment of ADHD are especially disturbing, considering many children have been
misdiagnosed with ADHD in the first place.
Which leads us to
the tragic case of Naika Venant, the 14-year-old Florida foster child
who recently hanged herself in the bathroom of her Florida foster home,
witnessed in real-time on Facebook Live. Medical records
from a medication management visit the month prior to her suicide
indicate psychiatrist Dr. Scott Segal increased Naika's doses of Vyvanse and Zoloft (sertraline) to
50mg each.
Like Gabriel, Naika
was prescribed 50mg of Vyvanse. Like Gabriel, Naika was also
prescribed an antidepressant. Like Gabriel, Naika also hanged
herself in the bathroom of a Florida foster home. Almost
inconceivably, the medical offices where Gabriel and Naika were
treated have the same street address, too. Which leads to an obvious
question: Was Naika involved at some point in a clinical drug trial,
like Gabriel?
Centers for Medicare
and Medicaid Services (CMS) records
indicate Shire, the manufacturer of Vyvanse, paid the Segal Institute
for Clinical Research over three hundred seventy thousand dollars
from 2013 to 2015. In response to a complaint
alleging Dr. Segal enrolled a subject with a diagnosis of bipolar
disorder in a schizophrenia study, the FDA previously inspected the site,
initially classifying the inspection in the field as requiring
voluntary corrective action, a classification subsequently amended at
headquarters based on evidence of a dual diagnosis later supplied by
Dr. Segal.
Even so,
the DCF incident report
in response to Naika's suicide does not reflect as favorably on the
doctor(s) who prescribed her drugs for ADHD and depression, going so far as to
question whether she even had ADHD in the first place, and noting the
cascading effect of such a diagnosis:
Lastly, there was a noted concern regarding possible inaccurate and
multiple diagnoses. Naika’s primary diagnosis consistently remained
Attention Deficit Hyperactivity Disorder (ADHD). An ADHD diagnosis
for a child who has suffered trauma, however, comes with its
challenges, including how often symptoms of trauma in young children
mimic those with ADHD. A psychological evaluation conducted with
Naika stated that there is much concern that her attention
problems are due to anxiety and trauma rather than ADHD
symptomatology and recommended further evaluation to clarify the
ADHD diagnosis. However, it does not appear that further evaluation
was conducted. In addition to the ADHD diagnosis, Major Depression,
Post Traumatic Stress Disorder and Disruptive Mood Dysregulation
Disorder were given by various treating mental health professionals
over the course of Naika’s life. However, limited documentation
within the assessments does not appear to support these diagnoses or
the medication prescribed
[emphasis added]. An additional consideration is the cascading
effect of a diagnosis, which drives the development of the treatment
plan.
With respect to
other suicides noted in its recent Vyvanse pediatric safety review,
the FDA seemed to trivialize fatal adverse event reports associated
with the drug, chalking them up to comorbidities and teen angst: “It
is difficult to perform a causality assessment of suicide-related
events and lisdexamfetamine from the postmarketing cases, because of
the comorbid conditions... and the prevalence of youth suicides.”
Readers familiar with our research
published on Mad in America will recognize this FDA Vyvanse pediatric
review as the same document the agency retroactively redacted to
cover up the homicide of an infant by a child prescribed the
stimulant – a day after Shire submitted a New Drug Application
(NDA) for a chewable formulation of the drug intended for young
children. Nothing to see here, move along.
Children are our
most precious resource, and foster kids are among the most vulnerable
of them to whom our society owes a special duty of care. As Dr.
Breggin pointed out: “These children need to be treasured and
protected, and to be given wrap-around loving care. They do not need
psychiatric drug interventions, which inflict more neglect and abuse
by suppressing their mental functions in order to make them more
manageable.”
If the FDA will not
fulfill its mandate to seriously investigate pediatric psychotropic fatalities and adequately warn the public of elevated polypharmacy risks, then
it's up to us as parents to spread the word ourselves.
Big Pharma about to feel the "Bieber" effect. In GQ article, Justin Bieber details how his doctor first prescribed him Adderall off-label for lack of sleep, then told him to quit the ADHD stimulant drug because it was causing him anxiety. Singer says feels "fine" now off Adderall, taking "natural" aids. You can bet Pharma Execs texting, emailing each other in a panic wondering what to do. Millions of Beliebers to follow singer's lead and ditch their anxiety-inducing amphetamines?
http://www.gq.com/story/justin-bieber-gq-interview
John Oliver did a scathing
critique of so-called native journalism. It's alternatively referred to as brand journalism, or sponsored content. The various terms describe an increasingly frequent occurrence whereby traditional print journalism, formerly monopolists in captive regional markets now struggling to find profitability in a crowded online news marketplace, are selling their logo to the highest bidder to help corporations market their brand to consumers, cloaked in a thin veil of journalism. Whatever you prefer to call the trend, it's a disturbing phenomenon that threatens to choke what's left of the free press in a sea of green. The wall separating church and state (advertising and editorial) appears to have developed some serious cracks.
Why you'll never see an article in the Washington Post critical of Big Pharma...
WAPO Selling Sickness for AstraZeneca
http://www.washingtonpost.com/sf/brand-connect/wp/tag/astrazeneca/
WAPO Selling Sickness for PhRMA Lobby Interests
http://www.washingtonpost.com/sf/brand-connect/wp/tag/phrma/
Does taking money to improve the brand image of pharmaceutical companies affect their coverage of the news when it involves Big Pharma? Well, let's see...
Take, for instance, this "safe as aspirin" piece WAPO did when it came to light that Naval Shipyard shooter Aaron Alexis was prescribed the antidepressant Trazadone by the Veterans Administration just days before his deadly shooting rampage that killed 12 people...
https://www.washingtonpost.com/national/health-science/trazodone-antidepressant-used-by-aaron-alexis-described-as-very-safe/2013/09/18/4336c044-20ae-11e3-966c-9c4293c47ebe_story.html
WAPO makes no reference to the fact that the FDA has warned patients taking Trazadone to contact their healthcare provider immediately if "acting aggressive, being angry, or violent" or "acting on dangerous impulses"...
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf
Next time you read an article after the next school shooting that essentially says, nothing to see here, move along, these drugs are prescribed to millions and are as safe as aspirin, keep in mind who is ultimately paying that reporter's paycheck.
To put the scale of the problem into perspective, Robert Kennedy, Jr. tells a story of how one network executive told him over dinner that 70 percent of their ad revenue comes from Big Pharma, and that anyone responsible for losing a big account will lose their job.
Response to Charles Krauthammer's Op-Ed Another massacre, another charade suggesting that psychosis, not guns, is the real cause of mass shootings in America.
On the one hand, Mr. Krauthammer suggests that more aggressive psychiatric
intervention might make a difference; and on the other he states that Roseburg shooter Christopher Harper-Mercer "had no psychiatric
diagnosis beyond Asperger's."
First, apparently Mr. Krauthammer missed the memo that Asperger's is no longer a
psychiatric diagnosis - it was voted out of the latest version of
the American Psychiatric Association (APA) Diagnostic and
Statistical Manual (DSM-5), published in May 2013. Many people
don't realize that so-called mental disorders are voted in or voted
out of American psychiatry's "bible," not scientifically discovered
or undiscovered. Another prominent example of a so-called mental
disorder going the way of the dodo by popular vote of American
psychiatrists is homosexuality, first included in, then excluded
from the DSM. Referring to the DSM-5, Dr. Thomas Insel, Director of
the National Institute of Mental Health (NIMH), declared,"The
weakness is its lack of validity. Unlike our definitions of ischemic heart
disease, lymphoma, or AIDS, the DSM diagnoses are based on a
consensus about clusters of clinical symptoms, not any objective
laboratory measure... Patients with mental disorders deserve
better... That is why NIMH will be re-orienting its research away
from DSM categories." (
http://www.nimh.nih.gov/about/director/2013/transforming-diagnosis.shtml
)
American psychiatry's inability to determine with scientific clarity
what does or does not constitute a mental disorder is compounded by
the fact that the United States is one of only two countries in the
world, New Zealand being the other, that allows direct-to-consumer
advertising by pharmaceutical companies. Big Pharma does such a
good job of disease-mongering -- often inventing then selling a
disorder and creating then funding corresponding "grassroots"
advocacy groups (aka "astroturfing") in order to sell their drugs --
that it makes it difficult to take back a mental disorder once it
has been invented and sold to the American public.
The first and most obvious flaw with the wishful thinking that more
aggressive psychiatric intervention might make a difference (read
prevent) mass shootings in America is that American psychiatry
cannot reliably define what a mental disorder is, let alone agree
upon and recommend its efficacious treatment.
Second, Mr. Krauthammer can't possibly know for a fact that Mr. Harper-Mercer's only
psychiatric diagnosis was Asperger's. This is a classic example of
jumping to conclusions, based on a report of out-of-context online
posts by a relative. It has also been reported that Mr.
Harper-Mercer's online alias was "Lithium_love." It should be noted
that if in fact Mr. Harper-Mercer was taking lithium, that drug is
indicated for Bipolar Disorder, not Asperger's (or Autism Spectrum
Disorder/ASD). So if Mr. Harper-Mercer was prescribed lithium, he
was either diagnosed with Bipolar, or the drug was prescribed to him
off-label. To be sure, off-label prescribing, as well as
polypharmacy (ie. prescribing multiple drugs), is rampant in
American psychopharmacology, a symptom of the shoot first aim later,
trial and error prescribing habits of an industry that has a tough
time defining mental illness, much less deciding on how to
effectively treat it. The reality is we will probably never know
the extent of Mr. Harper-Mercer's psychiatric diagnoses, or the
name, number and doses of the psychotropic medications prescribed to
treat them.
Third, Mr. Krauthammer invoked the Naval Shipyard shooter Aaron Alexis as an
example of someone whom he suggests did not receive needed
psychiatric help. In fact, Mr. Alexis received psychiatric care
from the Department of Veterans Affairs, in the form of a
prescription for the antidepressant drug Trazodone (
https://www.washingtonpost.com/national/health-science/trazodone-antidepressant-used-by-aaron-alexis-described-as-very-safe/2013/09/18/4336c044-20ae-11e3-966c-9c4293c47ebe_story.html
). Mr. Alexis went voluntarily to the VA for help with a
psychiatric symptom, and pills are what he was given. This is where
we get to the root of the problem, as well as expose one of the
biggest myths about mass shooters.
The fact of the matter is that most mass shooters in recent history
were under psychiatric care and were prescribed psychotropic
medications: e.g. Joseph Wesbecker (Prozac, lithium, trazodone,
temazepam), Eric Harris (Luvox), Edward Lutes (Luvox), Jeffrey Weise
(Prozac), Steven Kazmierczak (Prozac, Xanax, Ambien), Robert Stewart
(Celexa, Xanax), Kipland Kinkel (Prozac, Ritalin), Aaron Alexis
(Trazodone), James Holmes (Zoloft, Klonopin), Ivan Lopez-Lopez
(Celexa, Wellbutrin, Ambien, Lunesta), Aaron Ybarra (Prozac,
Risperdal), Bradley Stone (Risperdal, Trazodone), Elliot Rodger
(Xanax), Myron May (Vyvanse, Wellbutrin, Seroquel), etc.
The suggestion that the aforementioned mass shooters were not
receiving psychiatric care, and if only they had access to needed
psychiatric care then perhaps the tragedies might have been averted,
is misleading. The problem is that in America -- where doctors are
paid handsome consulting fees by pharmaceutical companies to pitch
their drugs to other doctors, and where the pharmaceutical industry
spends approximately $230M per year to influence Congress --
psychiatric care has become synonymous with psychotropic drugging.
The earlier choice of the words "in recent history" was not
accidental, because this tragic mass shooting phenomenon has only
been recent in America's history, since the clock tower shooter
Charles Whitman (Valium, Dexedrine) killed 16 people on the
University of Texas campus. In an upcoming documentary, Dr. Jean
Stolzer points out that "guns
have always been in this country since the first Europeans
stepped on American shores." (see also
https://leoniefennell.files.wordpress.com/2013/05/the-systemic-correlation-between-psychiatric-medications-and-unprovoked-mass-murder-in-america2.pdf
) Likewise, President Obama has pointed out: "The United States
does not have a monopoly on crazy people. It's not the only country
that has psychosis. And yet we kill each other in these mass
shootings at rates that are exponentially higher than any place
else. Well, what's the difference?" [NOTE: Most people missed the
fact that Mr. Obama's above response was to a question about mass
shootings posed via Tumblr by Nick Dineen, residential assistant to
UC Santa Barbara mass killing victim George Chen - whom the coroner
later determined was killed with a knife, not a gun, like two other
of Elliot Rodger's victims. Mr. Obama's response and Mr. Dineen's
question can be viewed here:
https://www.youtube.com/watch?v=NDVFs2l6-fo and the coroner's
findings that Mr. Chen, Weihan Wang, and Chen Hong each died of
multiple stab wounds can be viewed here:
http://www.sbsheriff.us/documents/ISLAVISTAINVESTIGATIVESUMMARY.pdf
. This demonstrates how jumping to conclusions based on initial
media reports can be problematic.]
Indeed, what's the difference? Neither guns or psychosis are new or
unique to America. So what has changed?
What has changed in America and what is unique to our country is the
alarming increase in the number of Americans taking psychotropic
drugs, which carry FDA-mandated label warnings of serious
psychiatric adverse events, including suicidal and homicidal
ideation.
For example, a recent study commissioned by the Louisiana Senate (
http://dhh.louisiana.gov/assets/ADHD/ADHD_DHH_RspnseRsltn39.pdf )
found that 35.8 percent of ten-year-old white boys were diagnosed
with Attention Deficit Hyperactivity Disorder (ADHD) and prescribed
predominantly stimulant medications, which an FDA Center for Drug
Evaluation and Research (CDER) medical reviewer found cause
hallucinations, mania, and psychosis at a rate of two to five per
hundred person years ( see
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4210b_11_01_AdverseEvents.pdf
and
http://www.fda.gov/ohrms/dockets/ac/06/minutes/2006-4210m_Minutes%20PAC%20March%2022%202006.pdf
). The FDA's medical reviewer also noted that the psychotic side
effects of ADHD stimulants occur in regular doses, in children with
no risk indicators or other psychiatric history besides ADHD, and at
a rate that cannot be considered rare.
Whereas in some places in our country nearly two out of every five
ten-year-old boys are being medicated with psychosis-inducing drugs
for ADHD, the estimated rate of ADHD diagnosis in Europe is less
than one percent (
https://www.psychologytoday.com/blog/suffer-the-children/201203/why-french-kids-dont-have-adhd
). Over-diagnosis and over-medication of psychiatric disorders is a
decidedly American problem.
Similarly, while Britain was banning antidepressants for kids due to
an increased risk of suicidal thoughts and behavior associated with
the drugs, the FDA threatened the same medical reviewer, Dr. Andrew
Mosholder, with an internal investigation, and prevented him from
presenting his findings that the drugs doubled suicidality in kids
at a Pediatric Advisory Committee meeting (
http://www.gpo.gov/fdsys/pkg/CHRG-108hhrg96099/html/CHRG-108hhrg96099.htm
).
According to the DSM-5,"Between 7 percent and 25 percent of individuals presenting with a first episode of psychosis in different settings are reported to have substance/medication-induced psychotic disorder."
Big Pharma invented and has successfully marketed the unproven
theory that mental illness is the result of a chemical imbalance in
the brain. Swallowing this marketing theory hook, line and sinker,
Americans are also swallowing psychotropic pills -- and shoveling
them into their children's mouths -- at rates dwarfing other
nations.
Ironically, there is evidence that psychotropic drugs derive their
action precisely by creating a chemical imbalance in the brain,
according to former NIMH Director Dr. Steven Hyman (
http://search.proquest.com/openview/5610c361a22516dda3dc72bb25f5371e/1?pq-origsite=gscholar
). Psychiatric medications, he wrote, "create perturbations in
neurotransmitter functions." The brain must then compensate to
adapt to "alterations in the environment." Chronic administration
of the drugs, he added, cause "substantial and long-lasting
alterations in neural function."
Referring to his own LSD trip, immediate past President of the APA,
Dr. Jeffrey Lieberman, wrote: "My [LSD] trip did produce one lasting
insight, though--one that I remain grateful for to this day...I
marveled at the fact that [if] such an incredibly minute amount of a
chemical...could so dramatically alter my cognition, the chemistry
of the brain must be susceptible to pharmacologic manipulations in
other ways, including ways that could be therapeutic." (
http://www.huffingtonpost.com/dj-jaffe/book-review-shrinks-the-u_b_6924810.html
)
We, as a nation, are reaping the fruits of this historically
unprecedented, massive-scale experimentation on the chemistry of the
human brain.
When most mass shooters were taking psychotropic drugs, it's an
insult to what's left of our collectively numbed intelligence to
suggest that more psychotropic drugs are the answer to mass
shootings. If psychotropic drugs were the answer, then the
astronomical increase in Americans' use of psychiatric drugs should
have led to a dramatic decrease in the number of mass shootings, not
an increase. Experience shows that more mental health treatment
with psychiatric drugs will lead to more mass murder, not less.
Take, for instance, the case of Bradley Stone. Not unlike Charlie
Gordon in
Flowers for Algernon, Mr. Stone might once have been
considered a darling example of the shining success of mental health
diversion courts and Assisted Outpatient Treatment (AOT) of the kind
advocated by Rep. Tim Murphy (R-PA) in his proposed Helping Families
in Mental Health Crisis Act (HR 2646) - that is, until Mr. Stone
shot and chopped up seven people, before poisoning himself with the
Risperdal and Trazodone he was prescribed and then stabbing himself
(
http://www.montcopa.org/ArchiveCenter/ViewFile/Item/2128 ). Or
there's Spc Ivan Lopez-Lopez who in the months preceding the second
deadly Ft. Hood shooting spree voluntarily met with a half dozen
Army mental health providers at Ft. Bliss, Ft. Leonard Wood, and Ft.
Hood on ten occasions, dutifully refilling prescriptions for
psychotropic medications (
http://www.pharmabuse.com/blogs/98 ).
At the very least, we know psychotropic drugs do not prevent mass
killings, since toxicology results for most of the aforementioned
dead mass shooters revealed the prescribed drugs were still in their
blood. Moreover, the FDA has received 765 reports of homicide as a
side effect of psychotropic drugs, many of which were multiple
homicides. Just as the now well-established link between
antidepressants and suicidality, which prompted a black box warning,
was once covered up, the extent of the temporal link between
psychotropic drugs and violence toward others has been concealed
from the American public. Now, thanks to a recent Freedom of
Information Act (FOIA) lawsuit filed against the FDA, we're
obtaining the relevant adverse event report records, and they will
be made public for the first time.
The FDA adverse event records support recent scientific studies
finding a link between psychotropic medications and homicide ( see
http://ki.se/en/news/study-analyses-link-between-psychotropic-drugs-and-homicide-risk
and
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0015337
).
U.S. taxpayers should not spend more money on mental health programs
promising to prevent mass shooting tragedies, because such
undoubtedly costly programs, by the very nature of their promise,
would be fraudulent. If anything, Congress should investigate
whether psychotropic drugs, which have been demonstrated time and
time again as being incapable of preventing homicide, may actually
be living up to their scary label warnings.
The guns versus mental health debate is a red herring. They are two
sides of the same coin - emphasis on coin, as in money. The gun
lobby and the pharma lobby are a marriage made in heaven (or, more
aptly, hell). We're hearing from the gun lobby that more guns would
help victims protect themselves from psychotic mass shooters. We're
hearing from the pharma lobby that forced mental health treatment
with psychotropic drugs, which the mass shooters were already
voluntarily taking, would prevent mass shootings.
The only lobby seemingly letting a crisis go to waste is the
entertainment lobby. We haven't heard that more violent video games
and movies would prevent mass shootings -- yet.
Everyone can agree that smoking cessation is a good thing. But the admirable goal of getting more people to quit smoking does not justify biased research which potentially puts more lives in danger.
The media is asleep at the wheel again, running headlines about a recently published U.K.
study,
acquitting the smoking cessation drug varenicline -- marketed in the U.S. as Chantix and in the U.K. as Champix -- of earlier reports of the drug causing serious neuropsychiatric adverse events, such as changes in mood (including depression and mania), psychosis,
hallucinations, paranoia, delusions, homicidal ideation, hostility,
agitation, anxiety, and panic, as well as suicidal ideation, suicide
attempt, and completed suicide. [The foregoing reported adverse events are verbatim from the drug's FDA-approved warning label.]
The FDA's concerns about Chantix were so serious that they prompted the agency to require the drug's manufacturer Pfizer to conduct and develop a Risk Evaluation and Mitigation Strategy (REMS), a rare step that has only been taken in a handful of cases.
Then, conveniently, along comes a study that absolves the drug once and for all of suspicion, clearing the way for millions more patients to be prescribed what cancer advocacy groups believe is a life-saving drug. Whew, we can all breathe a collective sigh of relief, and wipe the worry from our brows, right?
Not so fast.
One of the more troubling aspects of the study is that it was funded in part by
Cancer Research UK, an advocacy group that makes no bones about developing policy "to inform Government decisions related to cancer and research and communicates our views to key decision makers." We should be wary of advocacy groups funding research that supports the biased points they're trying to make. Not to pick on any group in particular, but would anyone take seriously a study funded by Scientology that concluded psych drugs are bad? Absolutely not. Which is probably why the Church of Scientology, reported to have deep pockets, has not funded scientific research to that effect. Yet there seems to be a double standard when it comes to advocacy groups that many deem to be worthy causes, whereby their sponsored research is taken at face value.
Research shows that pharma-sponsored studies typically return results favorable to the sponsor. Why would advocacy group-funded research be any different?
Then there is the thorny issue of trying to unravel the funding sources of Cancer Research UK, which does not acknowledge receiving corporate donations in its annual
report. The report acknowledges receiving £122 million in funding last year from direct giving, which the advocacy group says includes gifts from over a million people, further noting that "[m]ore than nine out of 10 of the donations we receive are less than £10." It is understandable why the advocacy group would want to stress the quantity of donations rather than the identity of the larger donors, but doing so doesn't bring us any closer to understanding from whence they got their funding. After all, if 900,000 [nine out of ten] people gave £9 [less than £10], then the group has only accounted for £8.1 million of the £122 million in direct giving it received last year.
The important issue of the group's funding sources and potential direct financial conflicts of interest with the pharmaceutical industry aside, there is no doubt that Pfizer's research objectives conveniently dovetail with Cancer Research UK's, as is evident by the drug makers
web site proudly entitled "Working in Partnership with Cancer Research UK." The term "evidence-based research" is as ubiquitous in the pharmaceutical world as "cloud services" is in the IT space. But no amount of throwaway clich
és can overcome the fact that sponsored so-called evidenced-based research is still biased.
Then there's the issue of where the study was published -- the Lancet, where two-thirds to three-quarters of the published trials are pharma-sponsored. Reprints of pharma-sponsored and pharma-favorable trials are a vital funding source for medical journals in general.
But wait, there's more. Two of the study's authors, Daniel Kotz and Robert West, have received funding for a smoking cessation trial and other research directly from Pfizer, the manufacturer of the drug being studied, scratch that, being heralded as free of negative effects. According to the study's credits, Daniel Kotz "originally conceived the study and drafted its funding application, and drafted the report."
How do sponsored studies consistently achieve results favorable to their sponsors? Through deliberately flawed (ie. rigged) study design.
Take for instance the laundry list of neuropsychiatric adverse events that the FDA requires Pfizer to include on the drug's label. Cancer Research UK's hand-picked doctors (it should be noted that only one of the study's six listed co-authors is actually a medical doctor) cherry-picked depression and self-harm as the only two neuropsychiatric adverse events to study -- to the exclusion of mania, psychosis,
hallucinations, paranoia, delusions, homicidal ideation, hostility,
agitation, anxiety, and panic, as well as suicidal ideation, suicide
attempt, and completed suicide.
Incredibly, whereas completed suicide is a reported adverse event, the study's designers "censored patients who were lost to follow-up because they left the practice or died." For all we know, some of the patients who died during the study may have committed suicide.
Likewise, of the 51,450 patients taking varenicline the study's authors identified, 1,287 or 2.5% were excluded from the study. For all we know, the excluded patients using varenicline may have experienced neuropsychiatric events (and cardivascular, which the study also examined).
The reason given for the exclusion? No match with patients using Nictotine Replacement Therapy (NRT). The study compared patients taking varenicline to NRT and bupropion (marketed as Zyban and Wellbutrin). The study identified 106,759 patients using NRT. Even though the NRT group's sample size was more than double the size of the varenicline group, the study's authors want us to believe that among patients using varenicline there was no match with patients using NRT 1,287 times. Then, as if by some cosmic coincidence, the study's authors excluded exactly 2.5%, or 164 out of 6,557 patients using bupropion for the same reason. Though the bupropion sample size is dramatically smaller than the NRT and varenicline groups, the amount of bupropion patients excluded for no match with NRT is the exact same percentage as varenicline.
The identical 2.5% exclusion rate for bupropion and varenicline patients is not a mathematical coincidence. The 2.5% exclusion rate for bupropion patients was most likely done to match the percentage of varenicline patient exclusions, so the study's authors could say, "See, we excluded the same percentage of bupropion patients as varenicline," to distract your attention away from the fact that they just made 1,287 varenicline patients disappear. Classic magic trick.
As if to confirm that the study is advocacy-sponsored research in support of advocacy policy, the study's authors conclude, "These findings suggest an opportunity for physicians to prescribe
varenicline more broadly, even for patients with comorbidities, thereby
helping more smokers to quit successfully than do at present."
The media is either woefully stupid (unlikely), or deliberately has its head in the sand. One can only wonder to what extent pharma ads buy media looking the other way when such blatantly biased studies are paraded out.
Meanwhile, more credible
research into reported varenicline adverse events concluded "that acts of violence towards others are a genuine and serious adverse
drug event that is associated with a relatively small group of drugs.
Varenicline, which increases the availability of dopamine, and serotonin
reuptake inhibitors were the most strongly and consistently implicated
drugs."
Statistics show that gender, race, geography, insurance, and income are the greatest risk factors that determine the likelihood that your child will be diagnosed with ADHD.
13.7% of boys in the U.S. are
diagnosed with ADHD versus 5.9% of girls in the U.S.
11.5% of Native American children in the U.S. are
diagnosed with ADHD versus 2.5% of Asian children in the U.S.
18.7% of kids in Kentucky have been
diagnosed with ADHD versus 5.6% of kids in Nevada.
13.1% of children on Medicaid are
diagnosed with ADHD versus 8.4% of children on private insurance versus 6.2% of children with no insurance.
13.1% of children whose family income is below the poverty threshold are
diagnosed with ADHD versus 8.9% of children whose family income is 200-399% above the poverty threshold.
Still think ADHD is a disorder stemming from a chemical imbalance in the brain?
TIME magazine article
The author of the article refers to a DOUBLING of the risk of suicidality (from 2%
to 4%) as "slight". The author also cites a gradual increase in suicides from
2000-2009, apparently in support of the theory that awareness of the
black box warning has scared people away from antidepressants, resulting
in an increase in suicides.
This is problematic, firstly, because the
black box warning on SSRI's did not even come about until 2004. From
2004 to 2009, more appropriately and more specifically, the suicide
rate increased from 11 to 11.7 per 100K. ( https://www.afsp.org/understanding-suicide/facts-and-figures
)
So a 6.4% increase in the suicide rate over 5 years is noteworthy,
according to the author, but a 100% increase in suicidality on SSRI's versus placebo is
"slight"?
Matters get worse for this sophistry - much worse. From the
period of 1999-2000 until 2009-2010, antidepressant usage increased from
6.5% to 10.4% of the general population. ( http://www.ncbi.nlm.nih.gov/pubmed/24345349
). So during the period when people were supposedly scared away from
SSRI's, their use increased by 60%.
Oh yeah, and by the way, that also
means that during the period when suicides increased by 6.4%,
antidepressant use was on the rise, too. No surprise, seeing as how the
manufacturers' own clinical trial data showed a doubling of the risk of
suicidality on SSRI's versus placebo.
Based on actual scientific data, a better article would not have examined whether to remove the
black box warning of suicidality on SSRI's, but rather whether we should
replace SSRI's as the standard of care for depression with a sugar
pill.
Furthermore, the author does not tell us who the 11
psychiatrists were who recommended removing the black box warning
(whereas she does tell us that 3 of the 4 in favor of the black box
warning were involved in the FDA's original decision to adopt the
warning), so we cannot cross-check for conflicts of interest among those
psychiatrists in favor of removing the black box warning.
When Republican Congressman Tim Murphy posted on Facebook that a stabbing and fatal shooting at Chabad-Lubavitch synagogue in Brooklyn a week before Hannukah was another preventable tragedy, some had doubts about his prescription to treat bigotry and
violence. Rep. Murphy, a psychologist, has prescribed his Helping
Families in Mental Health Crisis bill as a panacea for every societal
ill – from spree killings to suicide, homelessness and crime.
The violent attack at a Brooklyn synagogue came on the heels of the May 24, 2014 shooting spree that left four dead at the Jewish Museum of Belgium in Brussels, and the March 19, 2012 shooting spree that left four dead at Ozar Hatorah Jewish school in Toulouse.
Toulouse killer Mohammad Merah, an Al-Qaeda militant, had been on a terror
watch list since 2008 after being caught planting bombs in Afghanistan. Brussels killer Mehdi Nemmouche, an Islamic State militant, was
identified by French journalist and former hostage Nicolas Henin as being one of his captors and torturers in Syria.
After casing the Brooklyn synagogue twice earlier in the evening, Calvin Peters charged into Chabad-Lubavitch in the early morning on December 9, 2014, stabbing 22 year-old Israeli student Levi Rosenblatt multiple times, before being shot dead by police. According to a Chabad-Lubavitch
spokesperson, witnesses heard Peters shout repeatedly "Kill the Jews!"
Memories were still fresh from the April 13, 2014 Passover Eve shooting spree targeting the Jewish Community Center of Greater Kansas City and the Village Shalom retirement community in Overland Park, where neo-Nazi Frazier Glenn Miller, Jr. opened fire, killing three. Miller, a white-supremacist and former Grand Dragon of the Klu Klux Klan in North Carolina, was
reportedly heard yelling "Heil Hitler!" as he was taken into custody.
The Brooklyn synagogue attack was also reminiscent of the July 28, 2006 shooting spree targeting the Jewish Federation of Greater Seattle, where Naveed Afzal Haq shot six women, killing one. According to a probable cause
affidavit, Haq told a 911 dispatcher, "These are Jews and I'm tired of getting pushed around and our people getting pushed around by the situation in the Middle East."
In 2009, the FBI foiled a
plot to detonate explosives at Riverdale Temple and Riverdale Jewish Center in the Bronx; four men - identifying themselves as Abdul Rahman, Daoud, Hamza, and Amin - were each convicted and
sentenced to 25 years in prison. On an FBI surveillance video released as part of a recent
documentary film, Abdul Rahman can be heard commenting on the selection of Riverdale Temple as a bomb target: "I hate those bastards... Those f***ing Jewish bastards."
So what did Rep. Murphy mean when he said that another attack against Jews on U.S. soil was preventable? That the country should step up security at Jewish sites? No. That we should confront a culture that has fostered racism and anti-Semitism? No.
E. Fuller Torrey, a psychiatrist and founder of the Treatment Advocacy Center (TAC), supports Murphy's bill and lobbies for involuntary Assisted Outpatient Treatment (AOT) and psychotropic medication of the mentally ill. TAC maintains a so-called "Preventable
Tragedies Database" on its website.
Among the "preventable tragedies" in TAC's database is the story of Mansor Mohammad Asad. Mr. Asad disrupted Delta Northwest Airlines flight 2485 bound for Detroit from Miami International Airport on January 6, 2010 when he shouted "I want to kill all the Jews!" According to court
documents, Asad had a lengthy prior rap sheet, which included two counts of assault on a police officer. Asad
pleaded guilty to disrupting a flight, was placed on a federal "no-fly" list, and was ordered to pay the airline $27,500 in restitution.
Another story in TAC's "Preventable Tragedies Database" is that of Saudi national Yazeed Mohammed Abdulrahman Abu Nayyan. On February 21, 2012, Abu Nayyan was
removed from Continental Airlines flight 1118 from Portland to Houston after invoking the name of Osama bin Laden, swinging his fist at a flight attendant, and spewing hatred
for women.
Earlier that week, Abu Nayyan led police in Oregon on a
car chase, ramming into two police vehicles.
Abu Nayyan pleaded guilty to state charges of attempting to elude law enforcement and criminal mischief, as well as federal charges of interfering with a flight crew. He was ordered to pay restitution and returned to his native Saudi Arabia - where he now stands
accused of the April 8, 2015 assassination of two police officers in Riyadh. Saudi
officials say Abu Nayyan confessed to the killings, and they believe he acted with the assistance of the Islamic State militant group.
In a position
paper entitled "No Room at the Inn," of which Dr. Torrey is the lead author, TAC also cites the 2006 Jewish Federation of Greater Seattle shootings as an avoidable consequence of public psychiatric hospital closings from 2005-2010. Rejecting claims of insanity, jurors
convicted Naveed Afzal Haq in 2009 of first-degree murder, attempted
murder, unlawful imprisonment, and malicious harassment - the state's
hate crime statute.
He was sentenced to life in prison without parole plus 120 years.
During a congressional hearing on
Murphy's bill on June 16, 2015, former Congressman Patrick J. Murphy
testified, "The notion that we treat these issues as moral
issues as opposed to medical issues is really the central issue
before this committee."
The fundamental flaw with the medical approach of "treating" violence is that hate crimes are more a product of what is in people's hearts than of what is in their minds.
Accused Charleston spree killer Dylann
Roof wore symbols of racist oppression, expressed hatred of another
race, and intended to strike terror in the African-American community
and ignite a race war.
Misogyny appears to have been the
motive for Isla Vista spree killer Elliot Rodger, who sought to
punish random members of a gender with death for the slight of not
having sex with him.
Rather than target a particular religion,
race or gender, misanthropic Aurora theater shooter James Holmes
hated the entire human race indiscriminately, referring
contemptuously to the people he intended to slaughter as "sheeple".
What unites these cases more than mental illness is hatred.
Claims by Murphy, Torrey, Kennedy and others that somehow modern medicine can predict or even prevent such violent acts are false on their face, and amount to nothing more than shameless promotion of their respective self-interests.
If anything, these cases argue more forcefully against their proposed mental health interventions.
Toxicology
results showed Elliot Rodger had "benzodiazepines and alprazolam present within the body" at the time of his death. A recent Karolinska Institutet
study found an elevated risk of homicide associated with benzodiazepines, and to a lesser extent antidepressants.
Psychiatrist Dr. Lynne Fenton testified during James Holmes' trial on June 16, 2015 that she prescribed him 150 mg of the antidepressant sertraline and .5 mg of the benzodiazepine clonazepam. District Attorney George Brauchler asked Dr. Fenton during direct examination, "Did he ever tell you that he wanted to stop the sertraline?" She replied, "No."
Medical records released as part of a recent
documentary film revealed Riverdale Temple bomb plot conspirator Amin, aka Laguerre Payen, was reportedly prescribed 50 mg of the antidepressant Celexa (citalopram hydrobromide) and 100 mg of the antipsychotic Seroquel (quetiapine fumarate).
In defense of his client Yazeed Abu Nayyan's crimes in Oregon, attorney Mark Cogan
argued in court, "The cause for all these events was a change in the medication that was made by a doctor in California."
Clearly, modern medicine has not advanced to the point where it can cure hatred or prevent violence.
Filtering hate crimes through the prism
of mental illness is problematic, for reasons President Obama has
articulated: "The
United States does not have a monopoly on crazy people. It's not the
only country that has psychosis. And yet we kill each other in these mass shootings at rates that are exponentially higher than any place else."
The Congressional Energy and Commerce Health Subcommittee held a hearing
on Rep. Tim Murphy's Helping Families in Mental Health Crisis Act (HR2646) earlier this week.
Paul Gionfriddo, CEO of non-profit Mental Health America (MHA), was
among the witnesses called to testify. It should be noted that MHA,
formerly known as National Mental Health Association or NMHA, has
received
millions of dollars of
funding from the pharmaceutical industry.
Mr. Gionfriddo testified that two-thirds of individuals screened on
MHA's website screen positively for mental illness. If true, this is an
alarming percentage, and is less indicative of a mental illness epidemic
than it is of the inaccuracy of screening tools used to diagnosis mental
illness. Referring to the latest version of psychiatry's Diagnostic and
Statistical Manual of Mental Disorders, National Institute of Mental
Health Director Thomas Insel, M.D.
wrote, "The weakness is its lack of
validity... Patients with mental disorders deserve better... That is why
NIMH will be re-orienting its research away from DSM categories."
With the unreliable and inaccurate diagnostic tools available today,
increased early identification screening of children for mental
disorders proposed in HR2646 would almost certainly exacerbate already
out-of-control misdiagnosis and over-medication of children in our
country. This is a decidedly
American problem, with the rate of
diagnosis of ADHD among children
twenty times higher than in other
developed countries. Geographic disparities in diagnosis rates are attributable to
subjective, unscientific diagnostic tools. In the U.S., according to
the
CDC, children in Florida are almost twice as likely to be diagnosed
with and medicated for ADHD than children in California, Nevada or
Colorado.
Nowhere does the disturbing trend of misdiagnosis and wrongful medication
of children seem more manifest than in Mr. Gionfriddo's own family story. In
the
Washington Post, Mr. Gionfriddo wrote, "The school’s evaluations
suggested [my son Tim] had what was then called attention deficit
disorder... And it turned out that Tim probably didn’t really have
attention deficit disorder." Nonetheless, Mr. Gionfriddo also wrote in his
book, "The pediatric
neurologist started Tim on Ritalin... It turned out that neither Tim's
teacher nor we could see any difference in his behavior, attention, or
focus when he was on Ritalin. The reason, as we would discover later,
was that ADHD wasn't really his problem."
In what has now become an all-too-familiar and sad refrain involving people
put on perhaps unnecessary, the wrong or harmful psychotropic
medications, Mr. Gionfroddo
reported, "On Wednesday, November 20, 1996,
my son Tim brought a gun to school." Like Mr. Gionfriddo's son who was put on the ADHD drug Ritalin,
attorney Myron May was on the ADHD drug
Vyvanse when he brought a gun to his alma mater and began shooting FSU students on November 20, 2014.
While fortunately neither Mr. Gionfriddo's son or other students at his
school were harmed during that particular firearm at school incident,
after starting on methylphenidate, Tim was later
reportedly arrested in
a meth lab bust. Like methamphetamine, methylphenidate (Ritalin) is also a Schedule
II controlled substance. Methylphenidate carries an FDA-mandated Black
Box
warning - the strongest possible - for drug dependence.
Equally disturbing, years after Ritalin was approved and Mr.
Gionfriddo's son was placed on the drug, the FDA released a
post-marketing review, in 2006, of adverse event reports to the agency,
warning that the data demonstrated children with no risk indicators, on
regular doses of any of the stimulants approved for ADHD, experienced
hallucinations, psychosis and mania. According to
minutes of the March 22, 2006 FDA Pediatric Advisory
Committee meeting, Dr. Andrew Mosholder of the FDA's Division of Drug
Risk Evaluation noted that "symptoms of psychosis or mania were
estimated to occur [on ADHD stimulants] at a rate of 2 to 5 per hundred
person-years... This rate (greater than 1%) cannot be considered
rare..." Like other children seemingly misdiagnosed with ADHD and put on
psychosis-inducing stimulants, Mr. Gionfriddo's son would eventually be
diagnosed with schizophrenia, a condition often involving
hallucinations and psychosis.
It's time for America to step off the misdiagnosis and over-medication
roller-coaster. Due to the profit motive of some and despite the good
intentions of others, early mis-indentification of mental illness and
wrongful interventions are worsening, not solving the problem. During a mental health forum sponsored by Rep. Gus Bilirakis on December 16, 2014
in Land O' Lakes, FL, the bill's author Rep. Murphy
stated, "Forty percent
of the time a person with psychiatric problem [sic] is on the wrong
types or level of medication."
HR2646 is old wine (HR3717) in a new bottle. It's bad for America, and
it's bad for our kids. Parents are intelligent enough to make the right
mental health decisions and seek the right mental health care if needed
for their children. They do not need more intrusive, wildly inaccurate
and unscientific diagnostic screening thrust upon them or their children.
Our nation's over-reliance on pharmacological answers to life's
challenges is manifestly not working for our veterans and military
personnel, either. The Army's report on the 2 April 2014 Fort Hood
shootings concluded that the mental health care Spc Ivan Lopez received
did not deviate from the standard of care. Time to rethink the standard
of care, which included in Lopez's case an
untested polypharmacy cocktail of the psychotropic medications Celexa, Wellbutrin, Ambien and
Lunesta. Our service
personnel and veterans deserve better than being treated as guinea pigs,
experimented upon with risky, ineffective psychotropic polypharmacy.
On
the topic of Evidence-Based Treatment (EBT), can we agree that four dead
and twelve others shot is not evidence of a good outcome of medication
management? It should be noted that Army records indicate that Spc
Lopez attended at least ten counseling sessions dutifully over ten
months prior to the shooting; met with a social worker therapist, four
psychiatrists, and a nurse practitioner; sought multiple medication
refills voluntarily on a walk-in basis (Jan 14, 2014; March 6, 2014;
March 10, 2014), had psychotropic medications in his blood stream at the
time of death per his autopsy, and had even scheduled a follow up mental
health appointment prior to his death during a walk-in visit seeking medication.
The problem is not a lack of access to mental health care, a lack of
access to medications, anosognosia, medication non-compliance or
treatment non-compliance. The nature of the problem is American
psychiatry's fascination with an as yet unproven chemical imbalance
theory whereby mental illness is genetically hardwired into
individuals. Dr. Jeffrey Lieberman's exuberant hearing testimony
espousing the benefits of psychotropic medications, suggesting they can
prevent or eliminate mental illness, should be tempered by his comments
that
his faith in pharmacologic manipulations is rooted in his first LSD trip. Patrick Kennedy's impassioned testimony eschewing any moral
component of mental illness ignores man's soul, argues fatalistically
that we're all just chemical soup, and removes the element of free
will. It's no wonder depression can turn into despair, when
psychiatrists tell patients fate has dealt them a hopeless genetic hand.
Harvey Rosenthal testified in the hearing that people need to be offered
a promise of hope and recovery, and that Assisted Outpatient Treatment
(AOT) is synonymous with medication. Nowhere is this more evident than
in the push to erode the privacy rights of patients. Undermining
confidentiality, so long a foundational tenet of mental health care, is
a chilling indicator that the page is indeed being turned, some would say
forcibly, away from proven yet more time-consuming psychotherapeutic and
recovery modalities, in favor of quick but ineffective medication
management. In light of Rep. Murphy's stunning admission that doctors
are wrong about psychiatric medications forty percent of the time, we're
now going to take away patient privacy in the name of medication
compliance? To comply with the wrong medications? So that caregivers - often parents who previously forced their
children to take the wrong medications under poor
medical advice - can continue to harm their kids well into adulthood?
Let parents parent their minor children without intrusion. Let adults
make mental health care decisions for themselves. We need less, not more,
government intrusion into mental health care.
In his determination to erode privacy rights as well as the centuries-old legal protection against false imprisonment afforded by habeas corpus - based upon shaky psychiatric
diagnoses and worrisome doctor prescribing habits - Rep. Tim Murphy claims with
great dramatic effect that the mentally ill are dying with their rights
on.
Actually, they're dying with psychotropic medications in their corpses, and often taking others with them. Spc Ivan Lopez died with
antidepressants and sedatives in his body, and took three others with
him. Elliot Rodgers died with
Xanax (alprazolam) in his body, and took six others
with him.
Myron May
died with Vyvanse in his veins, almost taking six others
with him. Andreas Lubitz,
Germanwings co-pilot, took 149 other souls with him when, according to
the
BEA's preliminary report, he committed suicide by intentionally
crashing a plane into the Alps, after being prescribed antidepressants.
In the U.S., antidepressants carry an FDA-mandated Black Box
warning for
increased risk of depression and suicidal thoughts. Again, on the topic
of EBT, can we agree that 150 lost souls is not evidence of a positive
outcome of antidepressants? Can we agree that the aforementioned deadly
mass shootings are not evidence of positive outcomes of psychotropic
medications?
Ironically, as the HR2646 hearing was closing, testimony of Aurora theater shooter James
Holmes' psychiatrist Dr. Lynne Fenton was just getting underway in
Colorado. She testified that Holmes was on a psychotropic cocktail of
150 mg of Sertraline (Zoloft), .5 mg of Klonopin (Clonazepam), and 10 mg
of Propanolol. DA: "Did he ever tell you that he wanted to stop
Sertraline?" Dr. Fenton: "No."
The assertion that medication non-compliance is the reason people with a
mental illness become violent is simply not true. Medications are not
the panacea that Rep. Murphy portrays them to be, and in fact there is
credible scientific evidence to suggest that they may be
doing more harm than good.
Perhaps Murphy's bill would be more aptly named the Helping Big Pharma and Mental Health Industry Act.
The so-called sex pill for women does not crack any medical taboos, but rather runs a very familiar route in Big Pharma's playbook - deceptive manipulation of clinical trial data. What was different this time, from the other two when the FDA panel rejected Flibanserin, is that Sprout Pharmaceuticals ran a very effective "Even the Score" campaign making gender equality, not medical science, the issue. Big Pharma, with the help of Madison Avenue, successfully diverted our attention away from what really matters when approving or denying any drug - whether the drug is effective and whether it is safe.
Even panelists who voted to approve the drug this time under public pressure did so reluctantly, expressing concerns about the drug's marginal benefits as demonstrated by the clinical trial data.
In one study, there were 135 clinical trial dropouts on Flibanserin versus only 101 dropouts on placebo. Likewise, in another clinical trial, there were 95 dropouts on 50mg Flibanserin, 114 dropouts on 100mg Flibanserin, versus only 75 dropouts on placebo.
The side effects of the drug caused more subjects taking the drug to drop out of the trials when compared to placebo. In one study, 53 withdrew due to adverse effects of Flibanserin versus only 20 on placebo.
In typical Pharma fashion, those who dropped out of the clinical trials due to adverse effects did not get tallied in the final results, having the double effect of exaggerating the benefits of the drug while understating its risks. It would be akin to our public schools boasting that students' test averages have improved, because more students flunked out of school, raising the average of the remaining students.
Even with the skewed clinical trial data, Flibanserin only led women on the drug to have sex one more time per month over women on placebo. With such meager, albeit exaggerated benefits, to compare Flibanserin with Viagra is to deceive the public. Viagra actually works.
We are witnessing Pharma's new wave of demographically targeted marketing. It works, because co-opting existing, often worthy social agendas produces an instant "grassroots" movement. The clever marketing strategy works just as well in the bedroom as it does in the classroom. Racial equality, for example, has been successfully co-opted by Big Pharma to unnecessarily drug an alarmingly increasing percentage of minority children for "mental disorders" like ADHD, under the banner that they have previously been denied equal access to mental health care.
If gender equality is the crux of the issue regarding Flibanserin, then the disproportionate reaction to a drug with such doubtful benefits shows us that women can be deceived by Big Pharma just as easily as men.