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So, multi-billion dollar making pharmaceutical company, Pfizer, are in court. They are (as expected) denying the link between their antidepressant drug, their multi-billion selling blockbuster Zoloft (Sertraline) and birth defects.
Are we surprised at their denial or surprised that Zoloft can cause birth defects?
Well, neither really.
So here's the case.
Logyn Pesante, (11) from California, was born with multiple heart defects, the most serious being transposition of the great arteries. In a nutshell, transposition of the great arteries occurs when the two main arteries going out of the heart (the pulmonary artery and the aorta) are switched in position, or “transposed”.Since his birth Logyn has undergone 25 procedures and six operations and has a pacemaker. The brave 11 year-old has also had to undergo three open-heart surgeries to address his multiple defects.
His mother, Kristyn Pesante, took Zoloft during the first trimester of her pregnancy and her attorney, Joseph Zonies of the Colorado law firm Reilly Pozner LLP, is claiming that birth defects and fetal deaths, reported by patients to Pfizer as early as 1991 should have seen Pfizer change its label on Zoloft or, at the very least, communicate these adverse events to physicians.
Pfizer's attorneys, Paul Weiss Rifkind Wharton & Garrison LLP. are arguing that that there is no evidence to prove Zoloft causes birth defects. This, despite the adverse events reported to them by patients and also a study published in the New England Journal of Medicine in 2007 which found that pregnant women taking Zoloft faced double the risk of having a child with a birth defect.
More damning, for Pfizer at least, is a document submitted as evidence by Pesante's attorneys that shows a May 2014 internal report at Pfizer sees them admit that women taking Zoloft (sertraline) had an increased risk of having babies with heart defects. The document, Pfizer claim, has been taken out of context. Pfizer claim that, “Plaintiffs have taken a single statement in one document, summarizing the results of a few studies, out of context.”
Robert Cabera, a doctor at a University of Texas institute, has been called as an expert witness for Pesante and told jurors that his review of research on babies born with medical issues convinced him that Zoloft was clearly “a risk factor for birth defects, especially heart defects.”
I'll leave the last words with Beth Wilkinson, (Pictured) one of the lawyers representing Pfizer.
"None of the mother’s doctors had identified Zoloft as the cause of her son’s birth defects and experts say its impossible to know exactly what causes such problems.
“Sometimes, bad things happen to good people,”
The case is Pesante v. Pfizer Inc., 1222-CCO-2441, Missouri Circuit Court, 22nd Judicial District (St. Louis).
Pfizer Accused of Knowing Zoloft Posed Birth-Defect Risk
St. Louis jury hears nation's first suit claiming Zoloft caused birth defects
What is Zofran?
Zofran (Ondansetron) is the brand name of a drug marketed and manufactured by global pharmaceutical giants GlaxoSmithKline. It is used, primarily, for the prevention of nausea and vomiting following surgery and for cancer patients undergoing chemotherapy or radiation.
Off -Label Uses
It is also used “off-label” as a treatment for morning sickness in pregnant women, although it has never been approved for use in pregnant women.
Who is Arianah?
Arianah Reisen is a 2 year-old girl who was born with two “hole in the heart” defects. Her heart has enlarged to twice its normal size. She is scheduled to undergo open heart surgery next month. Her mother, Kylee Riesen, believes that Arianah’s condition was caused by the anti-nausea drug Zofran that she took during her pregnancy.
Why are GlaxoSmithKline being sued?
It is alleged that GlaxoSmithKline became aware of the Zofran birth defect risk in the 1990's but failed to warn expectant mothers and/or their doctors.
Can an anti-nausea drug really cause heart defects?
GlaxoSmithKline will argue that there is no proof that Zofran can or has caused birth defects but evidence suggests otherwise. They will also deny that they promoted its use "off-label."
Evidence - Zofran heart defects
At a 2013 meeting of the International Society of Pharmcoepidemiology, Jon T. Anderson, a researcher at the Copenhagen University Hospital, reported the results of a study of more than 900,000 births in Denmark. The report highlighted that women who took Zofran during the first trimester had a two- to four-fold increased risk of cardiac septal defects.
A 2013 study funded by the Centers for Disease Control and Prevention, found that Zofran increased the risk of cleft palate by nearly two-and-a-half times.
A 2014 Swedish study, published in Reproductive Toxicology, found a more than 60% increase in risk of cardiovascular defects and a two-fold (double) increased risk of cardiac septal defects.
Evidence of GlaxoSmithKline promoting drugs for "off-label" use
"GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs." (Source)
One of those prescription drugs was Zofran. In short, GSK:
Why did GlaxoSmithKline conceal this information from doctors and patients?
Anyone want to hazard a guess?
I've been blogging about GlaxoSmithKline since 2006. I even wrote a book about them (The evidence, however, is clear, the Seroxat scandal). During my time writing about them they have threatened to sue me for defamation (or libel - I can't remember what terminology their British lawyers used) They failed in that attempt to suppress my opinion.
I have a passion for justice, especially where it involves children, infants and fetuses harmed or killed by drugs manufactured by GlaxoSmithKline. I strongly believe that GlaxoSmithKline are in the business of putting profit ahead of patient care, be that with antidepressant drugs they market and manufacture, (Paxil, Wellbutrin) or be that with their diabetes drug, Avandia or, as is in this case, an anti-nausea drug, Zofran, they market and manufacture.
I don't like GlaxoSmithKline, particularly their CEO, Andrew Witty. I don't like their American lawyers that defend them in cases, nor do I like their British lawyers who defend them in litigation in the UK. It has occurred to me during the past 9 years or so of writing this blog that it takes a person with a blackened heart to defend a company that is corrupt to the core (That's my opinion and it's not aimed at any particular law firm who defend GSK)
Ideally, I would love to see executives of GlaxoSmithKline behind bars for the crimes that they have committed. It's the executives who make the decisions that are fed down to the managers, who in turn feed that information to the GSK reps. This is normally the crux of any litigation brought against GSK. Their executives deny promoting the use of unsafe, untested drugs, the managers deny, the reps deny. Evidence used in these types of cases will show that they are lying...this is the evidence that the Judge, 9 times out of 10, seals away from the public. It's a real beef of mine.
I am aware that litigation is all about reaching settlements between both parties, I just wish Judges involved in these types of cases would allow the evidence to go public once these cases have been settled. It's almost like they (Judges) offer GSK some sort of consolation prize when they are forced to settle cases.
This one is for Glaxo and lawyers representing them. I hope the images of Arianah Reisen play havoc with your sleep patterns... although I doubt very much that any human suffering conjures up any form of emotion in you. Zofran has made GSK an obscene amount of money. Meantime, children, such as two year-old Arianah Reisen, have to go through life by laying down on operating tables having their hearts worked on by heart specialists - all because GSK wanted to make a profit. It's utterly shameful and it warrants a form of justice, not just compensatory payment, it warrants jail time for all of those involved in the suppression of Zofran causing harm to babies. That, however, is down to the man, or woman, who holds the gavel.
Rant over. Here's two year-old Arianah Reisen.
For more information on the birth defects caused by Zofran and to see if you, or someone you know, has a potential claim, visit the Baum, Hedlund, Aristei & Goldman, PC Zofran page, HERE.
Baum, Hedlund, Aristei & Goldman, PC are the good guys. They've won many cases against GSK in the past and genuinely have their client's interest at heart (Pardon the pun)
An article in the Wall Street Journal from Feb this year was recently brought to my attention. The article in question reports on how psychiatric drugs are now being given to infants and toddlers in unprecedented numbers.
The article refers to an analysis of 2013 IMS Data. (the world’s leading health information and analytics company) The WSJ writes...
"An analysis of 2013 IMS Data, found that over 274,000 infants (0-1 year olds) and some 370,000 toddlers (1-3 years age) in the U.S. were on anti-anxiety and antidepressant drugs. This report also found over 1,400 infants were on ADHD drugs."I find this report quite alarming given that the majority of these class of drugs have never been proven to work in these age groups. More alarming, for me at least, is the fact that parents are allowing their children to take these mind altering drugs. Okay, look, I understand how difficult it can be if your child is acting up or crying all the time, I'm a father of three myself so I kinda know the score. But I cannot for the life of me think why any parent would allow these dangerous and addictive mind altering drugs to be taken by these little vulnerable people.
Let just look at the paragraph again.
"274,000 infants (0-1 year-olds) were on anti-anxiety and antidepressant drugs."
Now imagine London's iconic Wembley Stadium being filled three times by 0-1 year-olds. The photo below really shows you the scope of this problem. Put a 0-1 year-old on each of the red seats, give them each a diagnosis (a guess at what's wrong with them) them - treat them with powerful drugs purely based on that guess. Remove the 0-1 year-olds from each of the seats then fill the stadium again with other 0-1 year-olds - same process - have a man in a white coat diagnose them (guessing what is wrong with them) allow the same man in white coat to prescribe them mind-altering drugs. Repeat the process a third time.
The modern world
Now, here's the hypocrisy of it all. If we substituted the 0-1 year-olds for psychiatrists and we put a giant screen in the middle of the pitch with a slide show of a bunch of symptoms, the psychiatrists would diagnose and offer not only different illnesses but they would treat with different drugs too.
It's not science, it's purely profit driven and pimped by these idiotic bufoons in white coats who think they know how the brain works, when in actual fact they just don't have a clue.
"No conferring please, just write down what you believe the patient has then write down, once again with no conferring, how you would treat that illness."
Oh, by the way, here's what they mean when they say 0-1 year old's
Estimated age - between 0 - 1 years old
Who in their right mind would prescribe drugs to such a bundle of joy as the one above? Moreover, what parent, of sound mind, would agree to such lunacy?
What are medicine regulators doing about this? Well, in a nutshell, nothing. They claim that there are warnings on the drugs that state that they are not recommended for children - maybe so, but the word 'recommended' means jack-shit, even if you stick the word 'not' in front of it.
Will we see top executives of pharmaceutical companies speaking out about this lunacy? Of course not - these same executives have, in the past, devised clever marketing schemes to target this very same age-group.
So, what can be done? Do we just shrug our shoulders and do nothing and continue to post photographs of fluffy bunnies on Facebook or do we actually reach out to help these kids?
It's pretty shameful that so many kids are being diagnosed and treated with this vast cocktail of mind-bending addictive medications. It's pretty shameful that parents could neglect their own flesh and blood in such a manner and that the adults who look after the health and safety of consumers who take these drugs (FDA, MHRA, TGA etc) sit back and do nothing.
As for the pharmaceutical executives who have, in the past, told their reps to promote these drugs to this vulnerable age group, fucking shame on you.
Shame on us all for standing back and getting on with our own lives when these kids are targeted by the maniacs in white coats.
Here's the full WSJ article
Well, wouldn't you know it.
CNBC are running with the headline, 'Germanwings crash prompts overhaul, calls for more mental health checks.' - only thing is, the article does not state who is actually 'calling.' Is it the airlines, is it worried passengers or is it those that work in the field of mental health?
On Thursday The Boston Globe ran a very thought-provoking article regarding the 24 US Aircraft-assisted suicides between 1993-2012.
The data collected showed toxicology reports for 21 of the 24 pilots. They were unable to obtain toxicology reports for 3 of the 24 pilots.
So, we have 21 pilots to work from.
Out of those 21 pilots, 5 were on psychiatric medication, or at least had psychiatric medication in their bloodstream at the time of the Aircraft-assisted suicide.
Case #8 - Pilot (41) - Diazepam, Nordiazepam (anti-anxiety)
Case #9 - Pilot (40) - Alcohol, Cocaine, Diazepam & Nordiazepam (anti-anxiety), Temazepam (insomnia), Oxazepam (anti-anxiety/depression)
Case #14 - Pilot (54) - Venlafaxine, Desmethylvenalfaxine (depression)
Case #18 - Pilot (44) - Fluoxetine & Citalopram (depression), Diphenhydramine (allergic reactions/motion sickness), Alcohol
Case #22 - Pilot (25) - Alcohol, Citalopram (depression), Clonazepam (anti-anxiety)
It would be churlish of me to suggest that the drugs made them do it so, just like the Boston Globe data, I will show you the other mitigating circumstances.
Case #8 - Marriage proposal declined
Case #9 - Criminal history; suspect of arson
Case #14 - Under therapy for severe depression
Case #18 - History of depression w/ hospitalizations; shortly before the event, he was in hospital for attempted suicide
Case #22 - Distraught over breakup with girlfriend; alcohol and medication consumption prior to accident
Cases 14 and 18, it appears, show that the two pilots were diagnosed with depression and treated with medication. The other three cases don't seem so cut and dry.
Case 8 had a marriage proposal decline yet was found to have Diazepam and Nordiazepam (anti-anxiety) in his system. Was he being treated or did he just manage to get his hands on these tablets? If he was being treated then I cannot see anything in the Diagnostic Statistical Manual of Mental Disorders (DSM) that states that dealing with a marriage proposal decline is a mental illness.
Case 9 had a criminal history and was suspected of arson, yet in his blood system we find Diazepam & Nordiazepam (anti-anxiety), Temazepam (insomnia), Oxazepam (anti-anxiety/depression). Again, nothing in the DSM about using medication on someone with a criminal history.
Case 22 was distraught over breakup with girlfriend. In his system they found Citalopram (depression), Clonazepam (anti-anxiety). Since when does splitting up with a partner deem someone as being mentally ill?
So, a staggering 23.8% of pilots who took part in Aircraft-assisted suicides between 1993-2012 were on psychiatric medication/or had taken psychiatric medication prior to the suicide.
Now, we have more "calls" for mental health checks which will no doubt mean more pilots on psychiatric medication.
Now, let's take a look at the three pilots that they wasn't able to pull toxicology results from.
Case #11 - Restraining order; escorted away from home
Case #16 - Ongoing treatment for depression
Case #24 - Difficulties in personal life; joked about suicide
I think we can be, at the least, 90% certain that case 16 was on some form of antidepressant medication. If this was the case then it pushes the total figure of Aircraft-assisted suicides that were medicated up to 27.2% (6 out of 22 pilots)
If case 24 had difficulties in his personal life and was being treated, just as case numbers 8, 9 and 22 were, then the figure rises again to 30.4%
However, we cannot speculate.
The fact still remains. 23.8% of pilots who took part in Aircraft-assisted suicides between 1993-2012 were on psychiatric medication/or had taken psychiatric medication prior to the suicide.
Now let's breakdown the list of drugs.
Side Effect Reports – By Outcome
Completed suicide (1,885 reported)
Nordiazepam is the primary metabolite of diazepam
Completed suicide (1,885 reported) (diazepam)
Completed suicide (543 reported)
Completed suicide (87 reported)
Completed suicide (1,818 reported)
Completed suicide (147 reported)
Completed suicide (1,560 reported)
Completed suicide (2,191 reported)
Completed suicide (1,924 reported)
I don't know about you but I'd much rather know if a pilot was on antidepressant-type medication given the above results, wouldn't you?
Now, here's the rub folks.
On April 5, 2010, the FAA announced that pilots who take one of four SSRi antidepressant medications – Fluoxetine (Prozac), Sertraline (Zoloft), Citalopram (Celexa), or Escitalopram (Lexapro) – will be allowed to fly if they have been satisfactorily treated on the medication for at least 12 months.
Two from that list, namely Fluoxetine and Citalopram, were found in the toxicology reports of pilots #18 and #22.
It begs the question, why did the FAA, in 2010, announce that pilots would be allowed to fly on 4 SSRi type medications, two of which have since been found in pilots who have used an aircraft as a choice of suicide?
Will be interesting if German authorities release details of the prescription medications they found in the apartment of Andreas Lubitz, although I suspect the media will focus on his state of mind rather that what prescription medication may have contributed to his state of mind.
It ain't rocket science folks but the mainstream media are still missing the bigger picture, as are the FAA and other aviation authorities.
**Completed suicide figures obtained from RxISK drug database.
Co-pilot, Andreas Lubitz Germanwings
Andreas Lubitz - The Drugs Don't Work.
SSRIs Render Unfriendly Skies.
Documents obtained from the FAA under the Freedom of Information Act.
Following on from my previous post, Co-pilot, Andreas Lubitz Germanwings, where I suggested that the media should have been asking questions about the role psychiatric drugs may have played, its now being reported that medications (to treat mental illness) were found in the apartment where Lubitz lived by German authorities. The Australian writes...
"Large quantities of prescription medicines used for treating mental illness were found in his flat."
What's striking here is the plural, 'medicines.' If the press are correct in reporting that there were a number of psychiatric medicines then this story can go one of two ways.
First off, the press can focus on his medical condition, something they have already been reporting on. Most media outlets are suggesting that Lubitz was suffering from “severe overload syndrome.” Other newspapers are running with the term, "psychosomatic illness."
It's also being reported that Lubitz may have had vision problems but tried to hide this, and his psychosomatic illness from his employer.
So, a psychosomatic illness is defined as concerning or involving both mind and body. According to HealhGrades, a website aimed at professionals, psychosomatic illnesses can be classified in three general types.
"The first type includes people who have both a mental (psychiatric) illness and a medical illness, and these illnesses complicate the symptoms and management of each other. The second type includes people who have a psychiatric problem that is a direct result of a medical illness or its treatment, such as having depression due to cancer and its treatment.
"The third type of psychosomatic illness is somatoform disorders. Somatoform disorders are psychiatric disorders that are displayed through physical problems. In other words, the physical symptoms people experience are related to psychological factors rather than a medical cause."
Crystal clear, huh?
Now, if the media are reporting that this man had a psychosamtic illness and it appears he was being treated with prescription medications then one has to ask why?
Medscape, another website aimed at healthcare professionals, write...
"Based on studies of somatization disorder, medication approaches rarely are successful for this condition. Physicians should search for evidence of psychiatric comorbidity, such as depression or an anxiety disorder. If present, medication interventions specific to the diagnosis can be attempted. Successful treatment of a major depression or an anxiety disorder, such as panic disorder, also may produce significant reduction in somatization disorder."
I find the above quite laughable. On one hand medication for a diagnosed psychosamtic illness rarely works and, it appears, that healthcare professionals should search for evidence that points to another disorder. Once they find this other 'disorder' they can then, if they wish, medicate. Isn't this a bit like searching for something and just not accepting that what you are searching for isn't there?
A paper, published last year in PubMed, suggests that "there exists no systematic review or meta-analysis on the efficacy and tolerability of these medications." (1)
Furthermore, the authors found that "Adverse effects produced by medication can have amplifying effects on symptom perceptions, particularly in people focusing on somatic symptoms without medical causes."
Am I painting the picture for you here?
So, the media can focus on the psychosomatic illness that Lubitz allegedly had or, like me, they can start asking questions. Namely, why was Lubitz prescribed medications for his 'illness' when;
a, medication approaches rarely are successful for this condition.
b, there exists no systematic review or meta-analysis on the efficacy and tolerability of these medications
c, Adverse effects produced by medication can have amplifying effects on symptom perceptions, particularly in people focusing on somatic symptoms.
The German authorities have a duty to name the drugs this man was taking. The world press have a duty to ask the questions regarding the treatment of this illness.
Why was Lubitz on medication when published papers in high profile medical journals suggest that drug treatment doesn't really help?
I am kind of skeptical about the whole diagnosis. It's basically a psychiatric disorder diagnosed when no other psychiatric disorder can be found. It's a bit like your psychiatrist on a fishing trip. He throws his net into the water and catches just three fish. He then makes the net bigger and, voila, he lands more fish!
Judging by the media reports Lubitz was a troubled man. It would appear that his dream of flying and one day making Captain had been dashed. This could be because he had visionary problems or maybe because he had this ongoing psychosomatic illness.
I'm betting that the media will focus on his background and the illness and will not entertain the fact that the drugs he was prescribed may have contributed to his heinous act.
The jury's out folks.
(1) Pharmacological interventions for somatoform disorders in adults.
Kleinstäuber M1, Witthöft M, Steffanowski A, van Marwijk H, Hiller W, Lambert MJ.
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