“We understand this is about our licence to operate.”
GSK CEO – Andrew Witty’s comment about GSK’s 3 Billion fine for Fraud in 2012
As 2012 comes to a close, I thought it might be interesting to demonstrate to my readers the scale of the damage done by just one GSK drug in the past decade. That drug is Avandia- now severely restricted in the US- and more or less banned in Europe- because of it’s propensity to kill.
It has been estimated that GSK’s Avandia drug has caused up to 100,000 heart attacks in people across the world.
Just to give a visual image of the scale of damage from this one GSK drug alone- the following is a picture of 100,000 people at an Obama rally in Washington.
If we imagine that those 100,000 people have families and friends who are also affected because of the suffering of their friend or family member from an Avandia induced heart attack – then we can easily bring that number of people negatively or adversely affected by Avandia up to 500,000.
If we combine that figure with all the people who have been damaged by GSK’s other drugs- like Seroxat (Paxil)- which causes suicide, homicide and birth defects- then we could easily estimate that GSK’s drugs and products have caused in excess of over 1 million people adversely affected, damaged, or killed because of defective GSK drugs over the past decade.
Bear in mind- this further estimate takes into account just two GSK drugs (Avandia and Seroxat)- drugs that we know have caused widespread devastation for consumers. If we are to add the damage from their vaccines, and off label prescribed drugs– not to mention the cases of drugs which were contaminated (or in the wrong bottles)- from GSK’s Cidra factory– then we could easily bring that estimate of damage into the multiples of millions of people- either directly or indirectly damaged from GSK products over the past decade alone.
Happy New Year Folks…
Kudos to Bob Fiddaman:
SUNDAY, DECEMBER 30, 2012
Back in November I wrote how GlaxoSmithKline had been shortlisted for Britain’s most admired company. When I learned that they had been shortlisted I wrote a brief email to the editor of theManagement Today, who were offering the award. In a nutshell, I aired my disgust at their nomination, citing Glaxo’s various violations over the years.
Management Today never replied.
No surprise then that Glaxo were blowing their own trumpet on their Facebook page early in December after they had learned that they had won the most admired company in the Health & Household category. [Fig 1]
The Health & Household award was a sub-category and the reason why Glaxo felt the need to cover themselves in garlands on their Facebook page was probably due to the fact that they finished in26th position overall. Now there’s some spin for you, huh?
To arrive at the total scores, each company were marked out of 10 across nine criteria, such as quality of management, value as a long-term investment, financial soundness and capacity to innovate.
Um, yeh, we finished top of a sub-category but did poorly overall – how can we spin this?
Sounds like a clinical trial for Paxil in pediatrics. Ho hum, “remarkable efficacy”
I find it remarkable that:
a; Glaxo finished as high as they did
b; That Glaxo could even be considered for excellence with criteria such as, quality of management, value as a long-term investment, financial soundness and capacity to innovate
Not knowing how they arrived at their choices for most admired company, I’m left with nothing but my own thoughts.
1. Quality of management
Andrew Witty, in the eyes of the voters, has done a marvelous job in steering the Glaxo ship. Let’s forget about the $3 billion iceberg he hit and the case against his company in the UK where consumers are having to sue his company because they became somewhat addicted to an antidepressant and suffered horrendous side-effects as a result. Let’s also forget the up and coming litigation in Canada where the same antidepressant is, once again, on trial for causing heart defects in the most vulnerable of people, newborn babies.
2. Value as a long-term investment
Well, in the eyes of the voters, they must believe that despite Glaxo’s criminal behaviour and admittance of guilt that they are still worth investing in. Anyone with money should, as Glaxo’s CEO pointed out, think about the future of GSK rather than look back at a bygone era. The rich will forget about the 100,000 deaths or so related to Glaxo’s Avandia and the way they continued to promote its use despite knowing the problems it was causing.
3. Financial soundness
The voters may have thought that a pharmaceutical company like Glaxo always put money aside to settle cases brought against them – in any event, Glaxo will rarely admit to any wrong-doing so can continue to dupe the public into believing they only make drugs that are safe and effective, hey, if they didn’t then the British drug regulator, the MHRA, would say so. The current Head of Licensing at the MHRA is Dr Ian Hudson… before he joined the MHRA, Hudson was head of worldwide safety at GlaxoSmithKline [then SmithKline Beecham]
4. Capacity to innovate
To begin or introduce (something new)
Maybe the voters here have presumed that Witty’s “part of an era” excuse for his company causing misery to thousands of families globally actually means that they [GSK] are reinventing themselves. No more off-label promotion by their money-hungry representatives who have , in the past, been brainwashed by GSK management to tell doctors that drugs that can induce suicide in kids [Paxil] are actually safe for kids or that drugs manufactured for depression [Wellbutrin] could also be promoted as dietary supplements. Maybe the voters took on board the recent Glaxo internal memo that surfaced regarding their 6-in-1 vaccine, Infanrix Hexa. No surprise that 1271 page documentrevealed that GlaxoSmithKline received a total of 1,742 reports of adverse reactions between October 23, 2009, and October 22, 2011, including 503 serious adverse reactions and 36 deaths. Hey, innovation really working here. Maybe innovation means Glaxo will design more unique ways to keep the public from the truth, they are, after all, past masters of it.
Management Today should be proud of themselves for highlighting the 26th most admired company in Great Britain. The hoo-ha Henrys who sat around the table all growing chins have, I believe, a disdain for those affected by Glaxo’s drugs. Instead of bigging up the management they should be dissecting it bit by bit, morsel by morsel.
As for Witty, Glaxo’s CEO, he continues to hold his head high – “Not on my patch, honest guv”.
Next time Glaxo pat themselves on the back for being voted for a business award we should all remember that Glaxo spin results, they’ve done it since the dawning of time. They either try to make themselves look good or their products look good – the consequences of which are devastating for those left to pick up the pieces – consumers left hooked on antidepressant medication with no help whatsoever from Glaxo, mothers who have given birth to children with heart defects, families that have buried their dead because of GSK’s product causing heart problems, families left to bury their children and the memories of finding their children hanging from nooses.
Nice way to kick off the new year, nice kick in the teeth for all those who have suffered and continue to suffer because of the lack of compliance and mis-management at GlaxoSmithKline.
If you feel outraged enough by Glaxo’s award then rather than bitch about it on Facebook or Twitter why not email the editor of Management Today. He can be reached via email at email@example.com
There has been much comment made recently online about the new edition of the psychiatrist’s diagnostic bible- the DSM 5.
It seems that psychiatrists intend to widen the ‘depression spectrum’ now in order to include ‘grief’ as a form of mental illness.
It will be interesting to see if this proposal actually goes into the DSM 5 when it is published soon.
Personally- I think if ‘grief’ becomes medicalized by psychiatry- it would be a great travesty.
Psychiatrists have already bastardized the human condition to death, and pathologized human behavior to such an extent -that now almost anybody can be diagnosed with a psychiatric illness.
Is the psychiatric medicalization of the human grieving process a step too far?
One thing is for sure- it will widen the psychiatric catchment and make more billions for the drug companies
And that- seems to be the bottom line- as always.
By Ed Silverman // December 27th, 2012 // 8:04 am
In a move certain to create controversy, the American Psychiatric Association has voted to include bereavement in the definition of major depressive disorder, or MDD, that will be contained in the upcoming version of the Diagnostic and Statistical Manual of Mental Disorders, which will be known as the DSM-5, The Washington Post writes.
The decision is significant because the manual is widely considered to be a biblical-like reference tool for psychiatrists and by eliminating the so-called bereavement exclusion – which appeared in the last DSM that was published in 1994 – the APA may generate what some experts contend could be inappropriate diagnoses and treatment (back story).
When the possibility arose last year, The Lancet wrote an editorial noting this would mean “that feelings of deep sadness, loss, sleeplessness, crying, inability to concentrate, tiredness, and no appetite, which continue for more than two weeks after the death of a loved one, could be diagnosed as depression, rather than as a normal grief reaction.”
Such diagnoses could also boost the sale of antidepressants and the Post points out that the upcoming change in the DSM-5 was developed, “in large part, by people affiliated with the pharmaceutical industry,” which helps fund the APA. Moreover, most of the experts on the committee that drafted the new guideline have either ties to pharma.
Eight of 11 members of the APA committee reported financial connections to drugmakers, the Post reports, in the form of speaking or consulting fees, research grants or stock holdings, according to the disclosures filed with the APA. Six reported financial ties during the time that the committee met, and two more reported financial ties in the five years leading up to the committee assignment, according to APA records, the Post writes.
In addition, the paper adds that Sidney Zisook, a psychiatrist at the University of California, San Diego, and a key adviser to the committee, was the lead author of a 2001 study that found the Wellbutrin antidepressant could be used to treat bereavement. Glaxo, which sponsored the study, markets the Wellbutrin and Paxil antidepressants (see this).
As noted last year, he has received honoraria from Glaxo (GSK) and AstraZeneca (AZN), which sells Seroquel, an antipsychotic that is approved for adjunctive treatment of MDD, although he tells the Post that work preceded his involvement in the DSM-5 guidelines.
Such conflicts are not surprising. A paper published last year in PLos Medicine noted that 69 percent of the DSM-5 task force members have ties to drugmakers, which is up from 57 percent of the DSM-IV task force members. The paper also found gaps in the APA disclosure policy of DSM committee members (back story).
As we wrote at the time, 67 percent of the panel for mood disorders, 83 percent of the panel for psychotic disorders and all of the panel for sleep and wake disorders have ties to drugmakers that sell meds for treating these disorders or companies that somehow service the industry.
“It’s not that this is a Machiavellian plot by the pharmaceutical industry,” Lisa Cosgrove, a research fellow at the Edmond J. Safra Center for Ethics at Harvard University and a psychology professor at the University of Massachusetts, tells the Post.
“But when you have so many of these industry relationships on a committee, it creates a pro-industry bias that compromises their ability to be objective,” she adds. Cosgrove was a co-author of the PLoS Medicine paper that last year criticized the APA.
APA ceo James Scully Jr. tells the Post that the organization took steps to reduce conflicts as part of its preparation for the DSM-5. The APA, for instance, required that panel members regularly file disclosures and placed limits on their financial connections to drugmakers, the Post writes.
Each committee member was allowed to receive up to a $10,000 in annual income from drugmakers, hold as much as $50,000 in stock and receive unlimited amounts of money to conduct research. He maintains that, if no financial ties were permitted, many qualified psychiatrists would be excluded because many university studies are funded by pharma, according to the Post.
However, the Post notes that a survey of academic researchers found that 36 percent of full professors at medical schools report no financial connections to pharma in the previous year.
There has been much speculation about what motivated Adam Lanza to commit such an unspeakable massacre at an American elementary school.
One in particular involves the obvious correlation between school shootings/mass murders and psychiatric drugs (SSRI’s in particular).
Check out this video for more:
Powerful antidepressant and antipsychotic drugs approved only for use in adults are suspected of harming — in some cases killing — Canadian children.
Though Health Canada and the drug makers acknowledge the drugs are not approved for use in anyone under 18, doctors — often general practitioners with little psychiatric training — are prescribing these medications with little oversight.
Health Canada told the Star it has no jurisdiction to deal with the problem.
The regulator concedes the drugs may hurt kids but said it is up to drug companies to communicate the risks and doctors to safely prescribe the medications.
A Star investigation has found nearly 400 cases of children and teens suffering serious, sometimes fatal side effects suspected to have been caused by these drugs since 2002.
A 9-year-old boy’s breath shortened, stomach twisted and balance faltered before he died while on three different antipsychotics.
A 15-year-old boy experienced an irregular heartbeat and convulsed before killing himself while on antipsychotic Seroquel.
A 15-year-old girl on Prozac took her life in 2011.
Twenty-eight cases resulted in death, including the suicide of a 9-year-old boy three weeks after he started taking Zoloft, an antidepressant, in 2006. Convulsions and suicide attempts were among the most frequently reported suspected side effects.
“The prescribing of drugs falls within the practice of medicine . . . (Doctors’) professional judgment includes prescribing a drug to treat a condition for which it is not specifically authorized by Health Canada,” the country’s health watchdog told the Star.
Pfizer Canada, maker of Zoloft and Effexor XR, also an antidepressant, and three other drugs reviewed by the Star, said: “These medicines have not been approved for pediatric use by Health Canada. Pfizer Canada cannot recommend the use of any of its medications outside of product labelling.”
In about 35 per cent of the cases reviewed by the Star, kids 12 and younger were reported to have suffered serious side effects, including a 5-year-old girl who suffered seizures while on the antidepressant paroxetine (a generic version of Paxil), and a 6-year-old girl who experienced aggression, panic and personality disorder while on antidepressant Effexor XR.
“I am gobsmacked when I hear that. Why on Earth is a doctor putting a 5- or 6-year-old on a psychotropic drug? They’d better have a good reason,” said Dr. David Juurlink, head of the clinical pharmacology department at Toronto’s Sunnybrook hospital and a drug safety researcher.
So little is known about how these powerful drugs affect youth that the product pamphlets say the pills are not recommended for those younger than 18.
Pfizer and other drug companies say a lack of “sufficient clinical experience” or proven “safety and efficacy” are reasons why the drugs are not approved for kids. GlaxoSmithKline, maker of antidepressant Paxil, said “clinical studies . . . failed to demonstrate efficacy.”
Yet doctors are allowed to prescribe these drugs in what is known as an “off-label” use of the medication.
Each of the nearly 400 adverse reaction reports reviewed by the Star is the opinion of the doctor, pharmacist or parent that a particular drug has caused a side effect. Patients’ names and locations are taken out of the reports to protect their privacy.
About 75 per cent of the side-effect reports reviewed by the Star were made by doctors and other health-care professionals, and done so voluntarily. Canada’s flawed federal drug safety law does not require doctors to report side effects, even serious ones.
Health Canada and drug companies say side-effect reports show only a suspected connection between the drug and side effect but no medical proof that one caused the other.
The Star’s data analysis showed antipsychotic risperidone was named as the suspected cause in nearly 70 serious side-effect reports — more than any other drug reviewed by the Star.
Paxil was listed as the suspected cause in more than 50 cases, including six deaths.
Earlier this year, the U.S. Justice Department slapped GlaxoSmithKline, maker of Paxil, with $3 billion in fines following government allegations that, among other things, the company promoted the drug for use in kids while concealing evidence that it was ineffective.
Australian child psychiatrist Jon Jureidini, who has extensively researched Paxil’s safety and effectiveness in youth, said, “none of the antidepressant trials in children show any clinical advantage of the drug over a placebo. The ones that claim to have (shown such an advantage) have all got flaws in them, either scientific or in the way that they’re presented. That means we have no evidence at all to support the use of antidepressants in children.”
The problem is that many doctors, as well as Health Canada — which sends advisories and warnings about drugs to the medical community — do not know very much about the medications.
“We don’t know a lot about it simply because there is still a lot we don’t know about the brain. You will find fewer studies that look at this age group compared to adults with depression,” said Dr. Amy Cheung, a psychiatrist at Sunnybrook hospital who treats teens with depression. “There’s enough research data out there to show antidepressants are beneficial in the majority of teens with depression but in a small percentage of cases, patients can experience serious side effects.”
Some kids need the drugs. Dr. Cheung said she has seen children under 12 developing serious, debilitating mental illness such as anxiety, depression or schizophrenia and requiring medication.
Relying on their own experience practicing medicine, scientific journal articles and other sources, doctors can prescribe these drugs to kids. Many of the drugs are dispensed with pamphlets that warn of suicidal thinking and actions, and other possible side effects.
British Columbia’s government has issued guidelines for physicians diagnosing and treating children with depression. Doctors are directed to try “basic interventions” and therapy before resorting to prescribing pills.
In Ontario, however, neither the Ministry of Health nor the College of Physicians has a policy specifically on prescribing these unapproved drugs to children. (Non-regulatory professional associations such as the Canadian Academy of Child and Adolescent Psychiatry issue practice guidelines.)
• More and more kids are taking these drugs. Health Canada estimates prescriptions of antipsychotic drugs to children and teens in Canada spiked 114 per cent from 2005 to 2009.
• Health regulators around the world have published warnings that antidepressants may increase the risk of suicidal behaviour in kids and teens. The Star found these drugs were associated with 17 youth suicides and 28 suicide attempts in Canada since 2002.
To see a child psychiatrist can take more than a year in some parts of the province, and in less urban areas access to expertise is even more restricted, said Dr. Cheung, who added that talk therapy is often only available to those with private health insurance.
“Most family doctors have only a small proportion of their medical training focused on mental health compared to the training they receive in the diagnosis and management of physical illnesses,” she said. “But a large proportion of their child and adolescent cases are actually related to mental health issues.
“When a patient comes to you, depressed for three years and considering taking their own life, you try to do what you can for that teenager. Medication is one of the things you should consider as part of the treatment plan along with talk therapy.”
Depression experts urge caution when reviewing side-effect reports because depressed kids, before starting medication, are already at greater risk of suicidal behaviour. As a result, it can be difficult to tell whether suicidal thinking is caused by a teen’s depression or the drug used to treat the depression.
Still, doctors worry about their widespread use.
“The next time a girl is in your office crying that her boyfriend broke up with her, that’s not a reason to prescribe an antidepressant,” said drug safety expert Dr. Juurlink. “Doctors are part of the problem. We are way too free with our prescription pads. Partly we have a desire to do something helpful and partly we have a desire to get to the next patient.”
It is crucial that doctors closely monitor young patients, especially during the first few weeks of medication. “That’s when the “s— tends to hit the fan,” Juurlink said.
In 99 cases, the Star found children and teens suffered suspected serious side effects a month or less after starting the drug. In one case, an 8-year-old boy developed facial spasms and his muscles began to involuntarily twist and contract three days after he began taking risperidone, an antipsychotic.
Overworked or inexperienced doctors, however, may not closely track their patients, or the patient may skip follow-up appointments.
“Medical clinics are often not set up to allow doctors to closely track patients who miss appointments. Doctors also cannot force teens to return for appointments,” Dr. Cheung said. “It is critical that families try to help ensure these teens make it to their appointments.”
A recent review of the effect of risperidone and other antipsychotics on children found an increased risk of weight gain and movement disorders when compared to kids on placebos.
Calgary doctor and researcher Tamara Pringsheim, who did the study with funding from the Canadian Institutes of Health Research, said doctors and families of patients need to aggressively monitor kids on these powerful drugs.
“The most common reason an antipsychotic is being prescribed is not for schizophrenia but for ADHD,” she told the Star, adding that she has developed and is now promoting guidelines doctors should follow to detect side effects. “I felt physicians do need some guidance on how to keep it safe.”
Some countries take regulation of these drugs seriously.
In the GlaxoSmithKline case, the company pleaded guilty to criminal charges stemming from its failure to report safety data and “unlawful promotion” of certain drugs.
Part of the U.S. investigators’ case focused on the now infamous Study 329 on Paxil.
In a 2001 report, Study 329’s authors claimed their research showed Paxil was “generally well tolerated and effective for major depression in adolescents.”
The report became one of the most cited pieces of medical literature in support of antidepressants for youth, and an internal memo to Paxil’s sales representatives lauded it as a “landmark study” that “demonstrates REMARKABLE Efficacy and Safety (sic).”
But the results were skewed by selective reporting, said Dr. Jureidini, who co-authored a 2008 journal article on Study 329’s inaccuracies.
Study 329’s authors exaggerated findings on Paxil’s effectiveness and downplayed serious adverse reactions, Jureidini and his colleagues found.
Last year alone, Paxil was named the suspected cause of serious side effects in youth in eight reported cases.
“If you look at the science of Paxil, it says it shouldn’t be used at all in children,” Jureidini said. He said it’s “surprising and disappointing” that Canadian doctors are still prescribing the drug to kids and teens.
GlaxoSmithKline said Study 329’s authors “fairly presented the results” of the study and the company disputes “allegations that the … (2001) article on Study 329 was false or misleading.”
GSK said its plea with the U.S. Department of Justice regarding Paxil concerned only “some occasions when GSK sales representatives in the U.S. promoted the use of Paxil to physicians for patients under the age of 18, an unapproved use.
“The matters resolved as part of this settlement do not reflect the company we are today.”
In the U.K., the health regulator issued a blunt statement to doctors in 2003 that many antidepressants “are not suitable” for those younger than 18.
Many of the product pamphlets say the drugs “should not be used” by youth. Meanwhile, in Canada the language in the pamphlets distributed to doctors and patients is less forceful. They say the drugs are “not recommended,” “not indicated” or “not for use” in youth.
“The difference in language is probably a major deterrent,” said Dr. Juurlink. “When a doctor is told they should not do something, they generally don’t do it, or they think long and hard before they actually do. Simple changes in the wording are important.”
Several doctors told the Star that Health Canada is not doing enough to ensure drugs prescribed for unapproved uses are safe or effective.
Health Canada should track these off-label uses of drugs and check whether the unapproved treatments are medically sound, said Dr. Tewodros Eguale of McGill University.
Eguale led a recent study that found 11 per cent of roughly 250,000 prescriptions given to Quebec patients from 2005 to 2009 were for unapproved uses.
The study found antipsychotic drugs quetiapine and olanzapine were most often prescribed for unapproved treatments, such as depression and mood disorders, for which there is no strong evidence they are effective.
Without an effective treatment, a patient’s depression could worsen and lead to self-harm, he said.
Health Canada is “responsible for the safety and effectiveness of the drug and they’re also responsible for the general public’s health,” Eguale said. “It’s time to really look at the effect of when these drugs are used off-label.”
For Dr. Juurlink, the problem is more fundamental. “We would be facing a much less grave situation with regard to drug safety concerns if physicians were simply less eager to prescribe medications and patients less eager to take them.”
Data analysis by Andrew Bailey
VANCOUVER — Pharmaceutical giant GlaxoSmithKline says it conducted its clinical trial program for the antidepressant drug Paxil appropriately in marketing the medicine for use by women of child-bearing age.
The statement comes after a B.C. Supreme Court judge certified a class-action lawsuit launched by a B.C. woman whose daughter was born with a hole in her heart.
Lawyers allege the drug caused birth defects when taken during pregnancy, and say the company didn’t properly warn doctors about the risks.
In a statement, spokeswoman Michelle Smolenaars Hunter said the company acted appropriately in its clinical trials, marketing and safety monitoring, and updated pregnancy information as new information became available.
Faith Gibson’s daughter Meah Bartram was born just two weeks before the company warned doctors that taking the drug during pregnancy could increase the chance of cardiovascular defects.
One of Gibson’s lawyers, David Klein, argues the company ought to have known the risks before then, and is pointing to small-scale studies and studies on similar products that were already available to the scientific community.
A confidential GlaxoSmithKline document recently leaked to the press exposed that within a two-year period, a total of 36 infants died after receiving the 6-in-1 vaccine, Infanrix Hexa.  According to the website Initiative Citoyenne  who reported the news, the 1271 page document revealed that GlaxoSmithKline received a total of 1,742 reports of adverse reactions between October 23, 2009, and October 22, 2011, including 503 serious adverse reactions and 36 deaths. Initiative Citoyenne stated:
“It’s not that 14 deaths were recorded by GSK between October 2009 and end in October 2011 as we had originally calculated but 36 (14 from 2010 to 2011 and 22 from 2009 to 2010). In addition to these 36 deaths at least 37 other deaths (sudden death mainly), bringing the total to at least 73 deaths since the launch of the vaccine in 2000, and again, this concerns only the death by sudden death, no further recovery of under-reporting.”
Using the figure of 36 deaths over a two-year period, this averages 1.5 deaths per month, which by anyone’s standard is extremely high. Note that only 1 to 10% of adverse reactions to vaccines are actually reported. Therefore, in reality, the problem could potentially be far more serious and the actual number of fatalities much higher.
Considering this information, is it any wonder that babies are dying after receiving vaccinations containing these ingredients? GlaxoSmithKline may try and hide the facts from us but they cannot hide them forever. Infanrix Hexa should be removed from the market immediately.
Was Adam Lanza- the 20 year old school shooter- on Psychiatric Drugs?
Or was he seeing a psychiatrist like James Holmes?
In the coming days perhaps we will find out?
Beth Israel said her daughter was in the same class at Newtown High School with Adam Lanza, who lived six houses away.
“He was troubled for sure for a long time,” Israel said on Twitter.
Connecticut Shooter Adam Lanza: ‘Obviously Not Well’
Adam Lanza, the 20-year-old who killed 20 children and six adults at Sandy Hook Elementary School in Newtown, Connecticut this morning, was “obviously not well,” a relative told ABC News.
Family friends in Newtown also described the young man as troubled and described his mother Nancy as very rigid. “[Adam] was not connected with the other kids,” said one friend.
Late today, police said Nancy Lanza’s body was found in the family home. According to sources, Lanza shot his mother in the face, then left the house armed with at least two semi-automatic handguns and a semi-automatic rifle.
The drugging of our children and Adam Lanza
SAT DEC 15, 2012 AT 06:31 AM PST
According to a neighbor of Adam Lanza he was on medication for some type of personality disorder.
Yesterday, I speculated that AP reports of his condition suggested to me he was medicated for it. I sloppily slung together a diary trying to force my concerns to the surface and the diary didn’t get the kind of attention I feel this topic deserves.
I am deeply troubled by the potential toxic side effects of long-term prescription drug use of psychotropics.
First, drugs are typically approved based on clinical trials of adults with fully developed brains. A child may be prescribed psychotropics as young as age 5.
I challenge anyone to locate a significant peer-reviewed clinical trial of psychotropics where all test subjects are pre-pubescent.
Whereas antipsychotic drugs are not approved by the Food and Drug Administration for children; the FDA’s “black box warning” states antidepressants increase the risk of suicidal thinking and behavior in children and adolescents with psychiatric disorders; and drug safety experts have recommended additional “black box” warnings be placed on ADHD drugs: for the increased risk of stroke and heart attack;
Second, duration of testing on subjects does not span several years. Although FDA approval may take up to 8 years from drug synthesis to market, actual prescription schedules in studies do not sustain beyond typical usage periods in the real world.
It’s possible that we are rearing a generation of children who are the very first to be put on psychotropics so early and so long.
So the full array of effects of psychotropics in real time are unknown prior to market. We are raising these children and investing our trust and placing the health of our children in the hands of multi-billion dollar publicly traded corporate conglomerates. I don’t want that trust to be blind just because the man/woman who prescribes the psychotropics wears a white coat and gives your kid a lollipop.
Eric Harris, one of the Columbine shooters was prescribed psychotropics. James Holmes was seeing a psychiatrist but information has not been released about whether he had ever been prescribed psychotropics or lived most of his childhood on psychotropics.
Peculiarly, Adam Lanza and the Columbine killers and James Holmes share common traits that describe a digitalized, overmedicated generation. All of them come from affluent communities and mostly stable family units with access to prescription drug coverage. All of them are described as genius by at least one person in their circles, exhibiting normal cognitive function according to public education standards. And in the case of Lanza and the Columbine kids, they were avid gamers, quiet, shy and socially inward.
I’m not drawing any conclusions here I just want us to ask more questions.
Here is what I know and what has sparked my inquiry. Adam Lanza had been diagnosed with some type of personality disorder. AP reported this yesterday. Adam Lanza has been prescribed medication for it. Washington Post reported this today.
Here is what I don’t know: 1) when his young brain was first showered with these potentially toxic chemicals 2) how many years of accumulation contributed to complete mental detachment from reality 3) if chemical mixtures played a role at all.
But what I do know is that quiet honors students who grow up in loving families with no record of criminal history do not commit spontaneous acts of mass violence.
In 2002, Fox National News reported Douglas Kennedy exposed the link between psychiatric drugs and school shootings.
December 15, 2012 — admin
Sadly it’s happened again. This time in an elementary school in Connecticut.
We need to understand the cause and we need to go beyond the usual US gun laws discussion…
I’ve said it before and I’ll say it again – I wonder if antidepressant medication is involved?
I’m not saying antidepressants are the cause, I’m asking for you to consider if an adverse reaction to medication might be the catalyst for extreme, violent episodes in some patients
Why not check medical records? Why not collect data? Why not ask the question?
Big pharma has done no research (that we know of, at least), but I know of one study and I’ve made mention of it in a previously, but given recent events in Connecticut, I think it’s worth bringing up once more.
Published on September 12, 2006, this study by David Healy, Andrew Herxheimer and David B. Menkes deals with an issue that cannot be ignored.
“Recent regulatory warnings about adverse behavioural effects of antidepressants in susceptible individuals have raised the profile of these issues with clinicians, patients, and the public. We review available clinical trial data on paroxetine and sertraline and pharmacovigilance studies of paroxetine and fluoxetine, and outline a series of medico-legal cases involving antidepressants and violence.
Both clinical trial and pharmacovigilance data point to possible links between these drugs and violent behaviours. The legal cases outlined returned a variety of verdicts that may in part have stemmed from different judicial processes. Many jurisdictions appear not to have considered the possibility that a prescription drug may induce violence.
The association of antidepressant treatment with aggression and violence reported here calls for more clinical trial and epidemiological data to be made available and for good clinical descriptions of the adverse outcomes of treatment”.
The link to the paper is here and I suggest you scroll down to the end and read the 9 cases listed in the annex.
Also worth a look is SSRI stories.
And there’s a video here, in which film maker Michael Moore discusses possible causes in another school shooting – Columbine.
This article, from the Guardian UK, is almost ten years old. But it is still as poignant today as it was when it was published almost a decade ago now. Not only does this story illustrate the horrendous experiences of Seroxat Sufferers,and the brutality of Seroxat withdrawal, but it is also a damning indictment of GlaxoSmithKline- the manufacturer of Seroxat (Paxil). GSK have done nothing for Seroxat Sufferers, Seroxat Victims or Seroxat Survivors. They have offered no help, no withdrawal clinics – or not even a whisper of an apology in over a decade…
Touching the void
Regulators have just banned the prescription of the antidepressant Seroxat to under-18s. Novelist Helen Walsh, who was suicidal during her time on the drug, knows why
- Helen Walsh
- The Guardian, Thursday 12 June 2003Every scar has a story to tell and the two dozen fading wounds that track my body tell the narrative of my 12-month relationship with Seroxat. The most conspicuous, and by far the least imaginative of them all, are the horizontal lacerations that run parallel down my wrists. They were conceived in the week I decided to reject Seroxat. And with the same spiteful tenacity of the newly dumped, Seroxat made the break-up as painful as possible. It would rather have you dead than be without you.
I was first prescribed Seroxat in the autumn of 2001. I had suffered mood fluctuations since my late teens and in the month preceding my initial assessment, their intensity and frequency had become intolerable. I had known for a while that things weren’t quite right upstairs but I quite liked the belated states of euphoria that followed the surges of despondency. Then, I was at my most creative, alert and articulate. I could write for hours without tiring and talk the ears off anyone foolish enough to listen.
But the inevitable lows were drawn out and debilitating, rendering me mute, withdrawn and ferociously suspicious. By the autumn of 2001, the mood swings were happening four or five times a day. In between them, there were snatches of stability and rationality, and during one, I sought medical guidance.
My case does not subscribe to any of the current conspiracy theories on the internet, the most common being that GPs are blindly championing cost-effective Seroxat to guileless patients. My GP advised that I was suffering from depression and talked me through the whole range of remedial options, from counselling to drugs to homeopathic alternatives. I decided upon prescription drugs. Prozac was mentioned but I opted for Seroxat. It sounded softer, less severe.
After a few minor teething problems – nightmares, hallucinations, body cramps, feelings of profound guilt, disorientation and vulnerability – my body quickly acclimatised to the drug and things improved for a while. The mood swings were still there, but they were subtle and unthreatening, muffled by the woozy haze that Seroxat had thrown on everything. I was calm. Comfortably numb. Life was OK.
On Christmas Day, eight weeks into treatment, I took a knife to my skin and opened up my veins. Admittedly, I had been drinking the night before and I’ve always been a slave to a hangover. One thing I’d never done though, even in the wake of a mammoth post-binge lowie, was take it out on myself. That morning I woke up, stricken with terror and self-loathing, tiptoed downstairs, took a knife from the kitchen drawer then returned to my room where I calmly carved my arm and tummy to bits. I then bandaged myself up and went down for dinner. Prior to Seroxat I had never ever felt that impulse. I had friends who “cut” and I saw it as the most self-indulgent act of vanity.
In the months that followed, I stopped socialising and seamlessly distanced myself from the outside world. The need for isolation overwhelmed me. I began a binge of solitary drinking and self-destruction. I veered away from self-analysis and never questioned my actions. Seroxat didn’t allow you to. What lingered at the back of my head though was that no matter how bad it got, it would always be better than my pre-Seroxat misery, a dark and dingy netherworld I could never go back to.
What slowly became apparent was that the binges of self-destruction were triggered by accidental omission of a tablet. I didn’t think for a moment that the severe dip in mood brought about by forgetting to take a tablet was the onset of withdrawal symptoms. The small print confidently stated that only in certain cases would there be mild withdrawal symptoms. It reassured that Seroxat was not addictive.
In June 2002, I decided to come off the tablets. I was happy for the first time in ages. I’d finished my first novel, it was summer and life was good. My GP advised a gradual reduction over a period of six weeks. He stressed that under no circumstances should I just discontinue with the treatment. During the first two days of my reduction programme, I halved my dosage from 20mg to 10mg. I was emotional, hypersensitive, my skull pounded with angry electrical waves, my heart felt as though it might smash through my rib cage, there was a constant rushing behind my eyes and I had rapacious nightmares. It was tough, but not unbearable. I was quietly confident that these symptoms would pass. It said so on the small print.
What it didn’t say though was that three days into the process I would develop suicidal and homicidal impulses. There is a manifest difference between feeling suicidal and feeling abject desperation. Both gravitate towards the act of killing oneself, but with the latter there is always an innate safety mechanism stalling you; the thought of a loved one having to identify your corpse, for example. What I felt that day was suicidal. I had bypassed all the emotional hurdles and plummeted into a black void. The only thing running through my head was how quickly I could end it. My partner found me prostrate on the floor, clutching my skull, and quickly got in touch with my GP.
Five hours and 20mg later, I was fine. It was too early to come off the tablets, my GP told me – continue taking them for a while longer.
By December 2002, a full year later, I was coming off them – ready or not. I wanted my mind back. It was an agonising test of endurance, and it contributed to the near breakdown of my relationship. I felt suicidal on an almost daily basis and the need to self-harm was all-consuming. Four months on, I am managing just fine. I hadn’t quite realised how Seroxat had muted the senses. Everything is suddenly cleaner and sharper. I still can’t hang on to an opinion, a thought, for more than an hour, and I still vault from being blissfully in love with life, to being debilitated with despondency. I’ve been diagnosed with an acute form of bipolar disorder, where the mood swings can be hourly. The men in white coats are eager to pump me full of stronger mood-stabilising drugs, but until they drag me away in a straitjacket, I’m staying clean. When I’m not down, life is not just good, it’s brilliant. It may be a deluded state of happiness, but Seroxat is a deluded state of misery.
In recent years, mental illness has been given a radical facelift. Organisations such as Calm and Mind have dragged us depressives from the closet, while popular culture has provided a glitzy platform from which to out ourselves. And yes, it’s fantastic that we can be as open about depression as we can about asthma, but we are in danger of breeding a new generation of self-help groups who open their sessions with the line: “Hello, my name is … I am a seroxoholic.”
Unlike physical illnesses, mental ones are murky, mercurial categories that tend to resist clear-cut definitions, and a 20-minute session with a GP is not sufficient to determine whether you are suffering from a severe personality disorder or mild depression. The misprescription of drugs, then, is almost inevitable, and as far as Seroxat is concerned, could mean the difference between life and death.
“Trust is all about our permission to trade. Over time, the constant erosion of credibility builds up a real threat to the company’s business model… Trust is all about making sure that we face the issue head on, building credibility and being trusted by external stakeholders… it is time for GSK to step out and say ‘we’re going to do things the right way’.”
Global Employee Broadcast September 2008
Drugs Contaminated at GSK Uncovered
on January 2, 2011
Jan. 2, 2011 Drugs contaminated at GSK prescription factories of the major drug companies reveal that an inspector Cheryl B. Eckard who was interviewed on CBS 60 Minutes found disturbing facts of bacteria and two drugs mixed together in one bottle.
Cheryl Ekard Reduced to Tears on GSK Unethical Drug Production
Photo courtesy of Boston Herald
In one case the drug Paxil which is a powerful anti-depressant was found in a container with
which is used for ulcers and stomach problems. Two drugs mixed together for two entirely different groups of consumers who were unaware of what they were consuming in one drug bottle.
The outrage is clear and the FDA is again an agency too close to to drug company influence to be an effective stop gap against this type of danger to the consumer.
If a consumer was allergic to the drug Tagamet and was prescribed Paxil the problems appear to be unresolved by the FDA. As it was revealed the FDA did not demand the shut down of this Glaxosmithkline drug factory.
As the video reveals the mixture of several drugs in one prescription drug bottle, and bacteria found in an ant-bacteria medicine was uncovered in the drug factory in Puerto Rico. The Puerto Rico factory of GSK also made the diabetes drug Avandamet which was also mixed in with Paxil drugs.
As an employee of GlaxosmithKline Cheryl Eckard would know what she saw and what she documented in her reports which she relayed to the plant’s executives and to her own employer
GlaxoSmithKline’s head offices.
GlaxoSmithKline is the UK’s biggest drug producer hired Eckard to do a job and when she did they ignored the warnings and she wanted to shut the plant down but the higher ups refused.
The 60 Minute Video news story called
was aired January 2, 2011 on the CBS show 60 Minutes and the revelations are not only shocking they are disturbing.
It is not likely the head CEO did not know about what was going on at the factory level of his own company and if he did he is ultimately responsible for the damage that could be cause by such low standards. It would be like Toyota denying their products were defective and after all they tried that also. But this is a consumer product taken orally by a person who is assuming the drug is safe. Today, you can assume no drug is safe because they are not even tested anymore by the US government.
A quote from the company’s website regarding their corporate responsibility principals as they call it:
“We are committed to creating a strong ethical culture at GSK.”
They go on to say ” We do this by developing strong policies, recruiting the right people and equipping them with the information they need to make ethical decisions. Putting patients first is the core principle of being an ethical pharmaceutical company. Profit without principle is short lived.”
Failure to uphold high standards of ethical conduct carries significant business risk:
- Erosion of trust in GSK and our products including among regulators, doctors and patients
- Fines and litigation resulting in serious financial or legal consequences
- Damage to GSK’s reputation” end quote.
Ethics? GSK claims to have ethics?
Further, Cheryl Ekard was later fired from her job but here is a misleading tidbit from GlaxoSmithKline’s corporate policy on employees:
” Employment practices We will treat our employees with respect and dignity, encourage diversity and ensure fair treatment through all phases of employment. We will provide a safe and healthy working environment, support employees to perform to their full potential and take responsibility for the performance and reputation of the business.”
It certainly sounds good, but they do not really practice fairness and responsibility towards whistleblowers.
On human rights the copy is even more laughable:
“Human rights We are committed to upholding the UN Universal Declaration of Human Rights, the OECD guidelines for Multi-National Enterprises and the core labour standards set out by the International Labour Organization. We expect the same standards of our suppliers, contractors and business partners working on GSK’s behalf.”
The standards and ethics at GSK and this statement on their website is simply untrue and a blatant lie:
“Standards of ethical conduct We expect employees to meet high ethical standards in all aspects of our business, by conducting our activities with honesty and integrity, adhering to our CR principles, and complying with applicable laws and regulations.”
On how customers are regarded along with the standards of their product production it is hard to believe GSK abides by its own statements:
“Products and customers We will promote our products in line with high ethical, medical and scientific standards and will comply with all applicable laws and regulations.”
The lack of standards, ethics and following the law is glaringly lacking at GSK and the FDA has by it’s own failures allowed this corporation to continue operating in this manner. The FDA claims it has few inspectors however, this is simply not the case.
In 2004, Cheryl Ekard was forced hire a lawyer Leslie Ann Skillen and filed a claim against her former employer in Boston mostly since the FDA did not shut Glaxosmithkline down, or even found the errors and mistakes in their association with the drug company. The same production lines continued to pump out the wrong medications and Ekard demanded justice.
Again the failures of the FDA are a mile long list of complete ignorance and incompetence when it comes to keeping American consumers safe from the most basic errors. Two very different drugs mixed together can be deadly, can harm a person and can cause serious risks even death.
On November 26, 2010 GlaxoSmithKline ended up paying 750 million dollars for selling “adulterated drugs” and pleaded guilty.
The drug giant had to also pay medicaid program of Massachusetts eight million dollars for defrauding the government.
The GSK CEO’ boasts about their vaccine business in their quarterly profit reports -notice no mention of how they will improve their quality controls, how they will not fire whistleblowers and instead take heed that they are producing dangerous drugs.
2010 Report on Profits at GlaxoSmithKline.
This is laughable.
Defrauding the US government and the public is not the way to run a corporation, with such a low standard of ethics, stockholders and the Board of Directors have some say here in how this corporation runs their business. It appears GSK is more interested in profits than safety and ethics and this is a practice that is allowed by the FDA.
Editors Note: GlaxoSmithKline like many of the drug giants have a long history of violations, of producing harmful drugs, and of escaping culpability concerning jail time. A US federal habit of small fines is not a deterrent to these criminal acts which continue to endanger the lives of Americans and consumers worldwide.
Source: CBS Evening News-60 Minutes Scott Pelley Report Video
Tags: Drugs contaminated at GSK, Drugs, CBS 60 Minutes -Bad Medicine, Cheryl Ekard, CBS News Reporter Scott Pelley, Glaxosmithkline contaminated drugs, Glaxosmithkline mixed up drugs, paxil, tagament, Glaxosmithkline quarterly profits, Avandamet
Drug Companies in Bed with Government and Judges: On the Avandia lawsuit GlaxoSmithKline only paid $ 46,000.00 per person for endangering their lives with a heart attack from their product Avandia. The lawsuit was a sellout to patients who died, patients who had only diabetes but ended up with heart attacks as a result of taking a drug. The law, the courts, and the judges are all in favor of letting off these billion dollar corporations with small penal fines and settlements are far from punitive.
If you take Fosamax your jaw will be permanently damaged and your teeth will fall out, there is no proof this drug prevented osteoarthritis. Dentists are refusing to treat jaw death by Fosamax.
If you take Fosamax your jaw will be permanently damaged and your teeth will fall out, there is no proof this drug prevented osteoarthritis. Dentists are refusing to treat jaw death by Fosamax.
Just a little quote from the below article! Real freaking shocker, GSk saying one thing and doing the opposite!
A bunch of major F’ing assholes running this company.