"Truth will come to light; murder cannot be hid long."
William Shakespeare - Merchant of Venice (1596)
Let's make no bones about it. Study 329 is, and always has been, a ghostwritten publication based on deception and intended to result in financial gain.
The putrid stench of deception has been obliterated, redesigned and is now a sweet smelling single rose, a small token gesture of truth for all those harmed by GlaxoSmithKline's fraudulent 329 study, of which there are many (children and adolescents)
Study 329 is, without doubt, the most infamous of all antidepressant studies. It reeks of deceit, of greed, of dishonesty, of financial kickbacks and has left a slimy trail of death and destruction in its wake.
I have, for my part, written and published many articles on this blog regarding 329. Three of which, Sally K. Laden, The Paxil Ghostwriter Part I
, and Sally K. Laden, The Paxil Ghostwriter Part II - Emotional Lability
, ending the trilogy in this series with, Sally K. Laden, The Paxil Ghostwriter Part III - Summation.
being amongst the most popular.
329 highlights how one company saw a niche in the child depression market and, without due care and consideration, made unfavourable clinical trial results into favourable results.
329 is the spin of all spins, the retraction of which from The Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), has been called for many times.
Now, a group of tenacious researchers have shone a very bright light on what 329 should have revealed. Their findings will be published in the British Medical Journal (BMJ) next month.
Meantime, the Study 329 website
has been launched and offers some interesting facts about the fraud behind GlaxoSmithKline's darkest hour.
The Restoring Study 329: Efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression: restoration of a randomised controlled trial
, should shock all who care about integrity in drug safety.
I thought I'd heard the last of the Paxil horror stories. I thought doctors and psychiatrists would have got the message by now that Paxil is not safe, is not suitable for children and adolescents but...
A story hit me hard today, a realization that this abhorrent antidepressant is still destroying lives.
Shawna (not her real name but being used to protect the identity of her and her son) is a mother who has took it upon herself to fight for her 20 year-old son.
The story bears all the hallmarks of psychiatric abuse but, hey, how can you prove that when so many people believe that psychiatrists actually know what they are doing? In truth, they don't, in truth they use people as guinea pigs to see if they can tolerate drug a, b,c or d.
Shawna’s son was extremely shy and had just come out of a relationship. Shortly after he, according to a Canadian news website
, "spiralled into a deep, dark depression that saw him in his unlit room, unable to sleep, eat or perform even day-to-day tasks."
His mother did what she thought best and took him to a hospital where he was prescribed Paxil... yup, just like that.
This from the article...
He was prescribed the anti-depressant Paxil which she was told would help alleviate his depression, but instead it made things worse.
Shawna said the side effects of the drug were probably more devastating than his symptoms of depression. He started to threaten to kill him himself, sending her “goodbye texts” and wandering off without any contact for hours and hours.
“It was just crazy thinking,” she said. “You couldn’t get him to do anything. She said the final straw was when he spent 32 hours straight on the rocks at a local beach, contemplating whether he wanted to take his own life.
Shawna's son was then admitted to hospital where, she says, he received no care and was just left sitting in a room for three days with no visit from any psychiatrist. On the fifth day, however, he was seen by a psychiatrist.
**Insert drum roll here**
The psychiatrist told both Shawna and her son that he needed to be kept on the drug Paxil because it takes 30 days to work properly, despite the side effects.
Where does it say that on the Paxil labeling? Why didn't the psychiatrist associate Shawna's sons actions as an adverse reaction to the Paxil he was taking? If a patient is threatening to kill himself shortly after being put on Paxil why on earth didn't the treating psychiatrist acknowledge that this may have been down to the treatment?
So, Shawna's son continued to take the Paxil.
Here's the article again...
For the next month, she said, things were going from bad to worse. He was in and out of Aberdeen’s mental health unit as well as Kentville and Antigonish’s units for short three-day stays. After being released from the units each time, she would have to call the police to help search for him because the suicidal thoughts kept coming and the wandering continued.
Mental Health and the Police
Here's where the story takes a rather absurd twist.
Shawna was told by a police officer that the only way her son could receive proper treatment would be if he was arrested. She was told by the officer that her son, once arrested, would then be "in the system"
and "sent to Dartmouth for a 30-day mental health assessment."
A few months later her son was arrested for assault. Just as the police officer had told her, Shawna's son was given the treatment he needed - care. He is now on house arrest, under her care, and without the help of any psychiatric counseling.
The family doctor is slowing weaning him off the Paxil.
It's glaringly obvious to anyone reading this account that a 20 year-old kid was given a drug that gave him an adverse event, a dangerous adverse event. His treating psychiatrist should have intervened and guided his patient off the drug - instead, he chose to ignore the obvious signs of Paxil induced mania and told the kid to continue taking the medication. That's abuse by anyone's standards.
As for the mental health system in Nova Scotia, well, what can you say?
It takes an officer of the law to tell a patient's mother to, basically, get her son arrested, so he can receive appropriate treatment.
Talk about a comedy of errors!
: Mom desperate to get help for son
The Seroxat group action has been running for almost 10 years now. GSK have, for whatever reason, refused to make any kind of settlement to the 107 claimants who have alleged that they suffered severe withdrawal at the hands of Seroxat and, more importantly, were not warned about this dependency problem.
In 2010 the group action came to a grinding halt. A legal battle, behind the scenes, was unfolding and claimants, of which I am one, had their public funding withdrawn. This is quite common in UK action against pharmaceutical companies.
Sufficed to say, the group action was put on hold (stayed) whilst the legal wrangles were ironed out.
Good news is, we now have new representation.
Fortitude Law, a law firm based in London, are now representing the UK claimants and are set to return to the High Court to confront GlaxoSmithKline and show them evidence that Seroxat caused these withdrawal reactions to the claimants. I assume it will be the same evidence that US courts were shown back in 2002 when 3,000 or so claimants alleged that Seroxat caused them dependency. Glaxo resolved that case yet refuse to do the same in the UK.
The Fortitude Law website has now gone live and they have a contact form on there for people wishing to ask questions about the current group action.
Fortitude Law can be found here
As some of you may know, I became intrigued by the whole Kim Kardashian promotion of Diclegis on her Instagram account a number of weeks ago. My interest peaked when Diclegis manufacturer, Duchesnay employee, Danny Martel, wrote me on Twitter, basically telling me to "educate myself." (Back story
If you're up to speed on the whole Kardashian promotion you'll know that recently the FDA became involved. They told Kardashian to remove the advertisement and wrote to Duchesnay to inform them that they had violated certain rules in as much that they cannot advertise the benefits of a product without listing the risks of the said drug. The letter, addressed to Eric Gervais, Executive Vice President Duchesnay, Inc. can be viewed here
Bravo to the FDA for monitoring social networks.
Here's where is gets a tad worrying.
The FDA gave Duchesnay until August 21 to respond to the warning letter, they wrote...
OPDP requests that Duchesnay immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce. Please submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS.
Well, we are three days over the deadline and still I see nothing on either the FDA or Duchesnay websites that suggest that a response has been made - so, I wrote to the FDA, who told me that they "are not able to comment on an ongoing compliance action, as this information may be privileged confidential information. I’d recommend asking the company if they would be open to sharing information with you."
So, I wrote to Duchesnay and asked them the following...
I am writing to ask if Duchesnay are prepared to share their letter of response they wrote to the FDA regarding the Diclegis promotion (Kim Kardashian) warning letter.
I have wrote directly to the FDA who, in turn, suggested I write directly to you.
Duchesnay's response is bizarre, to say the least...
We will share information once it is publicly available. We do not have that information at this time.
Share the information when it's publicly available?
Um, I'm not nitpicking but shouldn't it be Duchesnay making this information public? I mean, what, or who are they waiting for?
The last paragraph of the warning letter sent to Duchesnay reads...
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
I think it's fair to say that this is a matter of public interest. Something which I pointed out to the FDA who then went on to tell me...
You could submit a Freedom of Information Act request. FDA Office of Media Affairs does not process FOIA requests.
Seems a kinda half-arsed way to get an answer to a pretty simple question.
Kim Kardashian on the Pharma Payroll
When Pharma Use the Defence of the FDA
Diclectin and the Redacted Adverse Events
Is It Just Kim Kardashian on the Duchesnay Payroll?
Duchesnay's Payments to Bendectin "Expert"
Covington - DOJ - Covington
I'm not really into American politics, not really into British politics either, I'd sooner read knitting patterns as politics, in general, bores me rigid.
That's not to say that every now and again something pops up that is of interest. None more so than the recent news surrounding US Attorney General, Eric Holder.
Holder was part of the legal team for the Department of Justice (DOJ) - the same team that fined
GlaxoSmithKline a staggering $3 billion for promoting its best-selling antidepressants (Paxil and Wellbutrin) for unapproved uses and failing to report safety data about its top diabetes drug, Avandia.
Bizarrely, Holder had previously worked for the law firm, Covington, who specialize in representing (defending) pharmaceutical companies in litigation.
It was quite a turnaround. One minute Holder is defending pharmaceutical companies, the next, he's prosecuting them.
Strange then that, after just 6 years with the DOJ, he should return
to Covington as a partner.
So, what input, if any at all, did Holder have regarding the negotiations of the $3 billion settlement figure, and, more importantly, could the original figure, said to be a lot more than $3 billion, have been whittled down by Holder? Furthermore, who was exactly behind the Wellbutrin promotion, was it, as some sources suggest, the current CEO of Glaxo, Andrew Witty, who, at the time
of the illegal promotion, was Vice President General Manager of Marketing for Glaxo?
I'm just throwing the question out there because this revolving door between Covington and the DOJ seems, to me at least, to be bordering on being incestuous.
News of Holder's double u-turn came via Melayna Lokosky who has wrote a quite brilliant blog post where she raises many questions regarding Holder's latest "unethical move."
Her blog can be read, in full, here
Lokosky also tweets about it via her Twitter account, here
One to keep an eye on.
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