pharmabuse's blog
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.
http://www.gq.com/story/justin-bieber-gq-interview
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.
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.
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 clichés 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."
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?
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.
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."
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.
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.
