Generic Paxil Suicide Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Tuesday, September 25, 2018

Spin Doctor or Bullying Victim?






David Baldwin Alleges Harassment

Spin Doctor

a person (such as a political aide) responsible for ensuring that others interpret an event from a particular point of view.

Extra, extra, read all about it!

Today's headlines in The Times and Daily Mail were designed to attract attention. Their headlines suggest their articles are about a government advisor being bullied online. Like many headlines, I believe these two are misleading.

The Times runs with, "Drugs adviser David Baldwin quits after being branded ‘worse than Hitler’ in online abuse row." The Daily Mail uses, "Government drugs advisor QUITS after sustained campaign of abuse that saw him branded 'worse than Hitler' over his stance on antidepressants."

It's important to note that both newspapers omitted the word "alleged."

They have stated Baldwin's claims as fact.

Baldwin's Hitler claim caught my attention as I was once threatened by GSK's attorneys when I wrote these exact words regarding a GSK employee back in 2008. Today I was struck by Baldwin's claim because 1.Baldwin quoted a phrase from 2008 that was identical to the one I said about a former GSK employee and 2. There is no evidence that anyone on social media or any blogger has said this about Baldwin.** (Update at foot of post)

Baldwin, who is no stranger to controversy, claimed pressure from bloggers and social media forced him to resign from the Prescribed Drug Dependence and Withdrawal Panel for the forthcoming Public Health England review. Baldwin would have represented the Royal College of Psychiatrists.

One would think Baldwin had a stronger backbone given his profession freely assigns labels to all and sundry. What's good for the goose, huh? I, and other advocates are often labelled "conspiracy theorists" and "pill-shamers" for speaking out about drug safety and efficacy. Apparently, we must have stronger backbones given we don't throw hissy-fits and quit.

What's worse, having your behaviour elicit the label "pharma-whore" or being subjectively labelled "mentally ill"? The first label suggests one takes money from drug companies to peddle their products, the second emphatically declares is not of sound mind. I know which label I find more offensive.

However, the alleged name calling isn't really the issue here. Baldwin's bullying claim is a sneaky tactic used by Baldwin and RCP to deflect attention from the real issue: Taking drug money while promoting the drugs. Undoubtedly, if Baldwin had been brave enough to sit on the panel he would defend these products to infinity.

Smoke & Fire

Did Baldwin really quit because he didn't like the names he was being labelled? In the field of public relations, false reasons are often given when a person resigns or quits. Perhaps, Baldwin quit because where there's smoke there's fire. It's bad enough his pockets are lined with unethical drug money. It's possible further enquiries would uncover more conflict of interest.

Bullying Those Who Suffer

Earlier this year, Baldwin and RCP President, Wendy Burn gaslighted all who have suffered adverse drug effects from the pills they promote as "antidepressants." They said, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment." (Fig 1)



(Fig 1)

Baldwin now claims this statement is supported by the National Institution of Clinical Excellence (NICE). It would be interesting to learn just how many patients NICE see on a daily basis.

To quiet the critics of this joint statement, Burn has somewhat retreated. She now claims in her "clinical experience" she has not seen problems with discontinuing drugs marketed as antidepressants. Burn states via Twitter she treats and prescribes these drugs to patients over the age of 60. She has received drug company money in the past but doesn't take it anymore. In a conversation with blogger, The Truthman, she told him, "I stopped taking money because I saw how it looked…" It's a pity she couldn't have relayed this to Baldwin.

The keywords in the above statement are "vast majority." Most people who suffer adverse drug effects don't appreciate having their prescribed harm diminished by doctors. Both Burn and Baldwin have had plenty of time to retract their statement and apologize. For whatever reason, they choose not to.

Super sleuth and podcaster James Moore queried the Times comment as it didn't tally with RCP's own study carried out and published on their own website. In that study, RCP learned that 63% of people suffered from antidepressant withdrawal. Once Burn was contacted by Moore, RCP removed the study from their website claiming, "It was out of date." However, due to the marvels of the Internet, the results of RCPs own study can be seen here.

Pharma-Whore

It is unknown when the term 'Pharma-Whore' was first introduced. It's been used many times to describe someone who takes money from drug companies and then promotes drug company products. Sometimes this promotion is through prescribing and sometimes it is through biased research and spin doctoring.

Why Baldwin feels his salary isn't enough for him to live on is beyond me. He is responsible for his unethical conflict.

In a 2003 article in The Guardian, Baldwin declared a personal interest in Lundbeck. The company makes the"antidepressant" called Citalopram, also known as Celexa in the US. Baldwin has also participated in advisory boards for SmithKline Beecham (Seroxat, Wellbutrin), and Eli Lilly (Prozac).

The Truthman wrote an interesting blog on Baldwin entitled, "Professor David Baldwin’s Lovefest With The Pharmaceutical Industry. Truthman said Baldwin was "instrumental in the promotion of Seroxat in the late 90’s." In 1998 Baldwin stated, "it (Seroxat) was one of the safest drugs ever made." Professor David Baldwin was also the lead coordinator of the European trial on paroxetine (Seroxat) for “social anxiety disorder.”

The Bloody Aftermath

Baldwin and Burn would have been wise to apologize and retract their joint statement. People are dying violent, bloody deaths that are due to drug withdrawal. This is not my opinion, violence against oneself and others is often precipitated by akathisia. There are four types of akathisia to include withdrawal.

After their joint comment in The Times, a formal complaint, headed by Dr John Read, a psychologist and mental health researcher, was lodged to the RCP. The complaint was dismissed by RCP without a full investigation and with no right of appeal. A new complaint was then sent to the new Secretary of State for Health and Social Care. It informed that “the Royal College of Psychiatrists is currently operating outside the ethical, professional and scientific standards expected of a body representing medical professionals.” It's presently unknown if the Secretary of State replied.

The spin-doctoring from Baldwin is regrettable when you consider human lives hang in the balance.


Bob Fiddaman

** The 2018 'worse than Hitler' claim reportedly came from a comment left on a blog post. (Not this blog, I hasten to add)

Back Stories







Other "Conspiracy theorists" and "Pill-shamers" discussing David Baldwin can be viewed at the following links.

GSK Licence to [Kill]

Hole Ousia

Mad In America

Mad in the UK












Sunday, September 16, 2018

No Action to be Taken Against GSK for Hiding Suicide Data





Earlier this month I posted previously unseen documents that clearly showed how GlaxoSmithKline (GSK) hid 9 suicide attempts from the results of a 1993 clinical trial posted on their website. See - GSK Study ID - 29060/356 - The Missing Suicide Attempts

The documents were sent to me by 'Kathy', who is the moderator of the Facebook page,  Australian Antidepressants Class Action & Awareness and an administrator for the Australians For Safe Medicines Facebook page.

After publishing my findings, Kathy wrote to the Therapeutic Goods Administration (TGA) and asked if they would be taking action against GSK for failing to report the 9 suicide attempts in the Aropax clinical trials, known as GSK Study #356.

The TGA's response is staggering, to say the least.

Dear Kathy

Thank you for emailing the Therapeutic Goods Administration (TGA). I acknowledge your concerns about the GSK clinical trial (A double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability) that was conducted in 1993-1994.  However, the TGA is unable to comment about the clinical trial as it was completed twenty four years ago.

As has been explained to you previously, the TGA’s safety monitoring is based on rigorous pre-market assessment and then the post-market signal investigation area of the TGA monitors the safety of medicines, to contribute to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials.

Thank you for your interest in medicine safety.

Regards

Bernadette Barton
Assistant Director
Adverse Event and Medicine Defect
Pharmacovigilance and Special Access Branch

--

On the 'About TGA' section of their website, they state: "TGA's approach to therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products.

Just to be clear, the results of GSK Study #356 failed to mention 9 suicide attempts, moreover, they failed to say which group these 9 suicide attempts pertained to. Study #356 had two active drugs, namely paroxetine and fluoxetine, both of which are selective serotonin reuptake inhibitors (SSRIs). There was no placebo group in the study.

As a regulator who claims to "manage any risks associated with individual products" I am utterly gobsmacked by their response above.

Surely a regulator should be asking GSK why they failed to include these 9 suicide attempts. Surely they should be telling GSK to publish the correct statistics and not a watered down version of what actually occurred during the study.

In essence, the TGA is saying, we don't care if the public doesn't know how many suicide attempts occurred in either the paroxetine or fluoxetine group. We don't care that GSK failed to report that the percentage of suicide attempts was a staggering 11.11%. We don't wish to manage these risks, even though we claim on our website that we do. We don't care the public isn't armed with this information when visiting their doctor or psychiatrist. We don't think 9 suicide attempts in a clinical trial is important.

I find the last line of the email kind of ironic: "Thank you for your interest in medicine safety."

Are they taking the piss?

Bob Fiddaman





Tuesday, September 04, 2018

GSK Study ID - 29060/356 - The Missing Suicide Attempts




Fluoxetine - AKA Prozac
Paroxetine - AKA Aropax, Seroxat, Paxil

Study ID - 29060/356
A double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability.


Snapshot was taken 3rd September 2018

Study ID - 29060/356/_1
Extension phase for a double-blind, multicentre study to compare paroxetine and fluoxetine in the treatment of patients with major depressive disorder with regard to antidepressant efficacy, effects on associated anxiety and tolerability.

Both studies appear on the GSK Study Register website, the second study is a continuation (extension) of the first.

As you can see, both studies were double-blind, which means neither the patient or investigator knew what drug they were taking/prescribing. After the trials have been completed, GSK can break the code and find out on which drug the adverse events occurred. In this case, one suicide in the paroxetine group and one in the fluoxetine group; no suicide attempts in the paroxetine group, and; two in the fluoxetine group, one of which was a completed suicide. In both groups, there was one suicide each, both were women.

According to recently obtained documents from the Therapeutic Goods Administration (TGA), the #356 trial reported 7 suicide attempts* (2 of which were completed suicides). However, there is no mention of the 5 attempted suicides on the GSK Study Register website, at least not for paroxetine. They do, however, cite two suicide attempts for patients taking fluoxetine during the trial, one of which was a completed suicide.

*Further, more documents show that there were in fact 9 suicide attempts in Study #356, however, there is no mention of this on the GSK Study Register website.

Masking the suicide attempts
GSK report that there were 6 subjects with non-fatal serious adverse events (SAEs) in the paroxetine group and 10 in the fluoxetine group. A total of five (2 paroxetine, 3 fluoxetine) are in the Drug Abuse (Overdose) category.

Drug overdoses
Could these be deemed as attempted suicides or were the overdoses unintentional? If, indeed, they were attempts at ending one's own life, then why is it not reported as such? Well, according to recently obtained documents, no suicide attempts were made by overdose.

Therapeutic Goods Administration (TGA)
Who are the TGA?

The TGA  is Australia's regulatory authority for therapeutic goods. They carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. They are the American equivalent of the FDA and British equivalent of the MHRA.

The Previously Unseen Documents for Study ID - 29060/356
These were obtained under the Freedom of Information Act and forwarded to me by 'Kathy' who runs the Australian Antidepressants Class Action & Awareness Facebook page. Kathy copied me in on a lot of the correspondence between herself and the TGA. The process of obtaining the following documents took a considerable amount of time; I'd estimate the best part of a year. Kathy's tenacity and doggedness paid off.

After initially requesting payment for the documents, the TGA apparently had a change of heart and released many documents pertaining to Study #356, most of which make for very interesting reading. Before I publish them, it's important you understand the reasons why there are many redactions (black-outs) in the documents. According to the Australian Freedom of Information Act 1982, there are a number of exemptions where certain information may be redacted. They include: protecting patient privacy; irrelevant material; documents disclosing trade secrets or commercially valuable information and; documents subject to legal professional privilege.

Human Research Ethics Committees (Australia)
It may be unethical for a researcher to continue a trial if:

(a) there are or have been substantial deviations from the trial
protocol;
(b) side effects of unexpected type, severity, or frequency are
encountered

National Statement on Ethical Conduct in Research Involving Humans

You'll hear more about the Human Research Ethics Committees (HREC) in the documents below.

First off, the two suicides...

32-year-old female 
Causality: "Possible"
Outcome: Death, maybe drug



46-year-old female
Causality: "Possible"
Outcome: Death, maybe drug




Attempted Suicides

According to the study posted on the GSK website, there were only two suicide attempts, both of which occurred in the fluoxetine group. One of these was fatal. However, the documents obtained from the TGA say something quite different. There is a contradiction as to exactly how many suicides attempts occurred. Firstly, according to a Paroxetine Clinical Study Meeting, Dr Sykes claimed there were 9 reported suicide attempts, two of which were completed suicides.

The study meeting, according to the document, was held on Friday the 26th of November, 1993



However, 4 months prior to Dr Sykes' claims, GSK, then SmithKline Beecham, sent a letter to all investigators involved in the trial. They stated, "...we have now received reports of 7 suicide attempts (including two deaths) for the 356 study comparing paroxetine to fluoxetine."

The letter, below, goes on to state how confident they are that, "the number of suicide attempts in this study is within that expected as a consequence of the depressive illness per se."

In other words, it wasn't the drug, it was the illness.



In between these two letters, we have a document from a Professor (dated September 1993). The letter was sent to the Research Ethics Committee.

GSK had made contact and told him about the suicides and suicide attempts. Here it gets interesting because it gives us the number of those enrolled (63). The Professor states, "...there have been seven suicide attempts including two deaths in the first 63 patients included in this Australian multicentre study." (11.11%)

The letter,, signed off by an Associate Professor at the School of Psychiatry, goes on to say how he had researched data and had found no evidence that either paroxetine or fluoxetine increase suicide rate or ideation in depressed patients. Remember, this was 1993 - no lawsuits had yet revealed the extent of those who had died or attempted suicide on paroxetine, or indeed Prozac.


In November 1993, the Research Ethics Committee ceased enrollments for the study because of the "reported cases of suicidal gestures'.  A review of the attempted suicides was needed before #356 could proceed.





#356 was halted and, it seems, an independent review of the study took place one year later. The independent review clarifies that there were actually nine suicide attempts, two of which were successful. In all, according to the review, there were 100 patients enrolled. The review, however, found no reason why the study shouldn't continue. (Attempted suicides = 9%)

Of the 91 patients who did not attempt suicide, the review states, "26 either withdrew or were withdrawn prematurely from the trial."  No reason is given for this.

According to the review, no suicide attempts were made by means of a drug overdose.

Here is the 25-page Independent Report.

Comment

Where are these missing suicide attempts? Why are they not reported on the GSK Study Register website?

There were 7 suicide attempts when 63 patients were enrolled (11.11%) . Surely this figure should have raised a red flag?

There were 9 suicide attempts when 100 patients were enrolled (9%) . Even this figure is astronomically high.

Investigators and review panels didn't really have much to go on back in 1993/94, apart from, of course, GSK's own information and published literature that was mainly ghostwritten by PR companies hired by GSK.

From the early onset of this study, GSK made it abundantly clear to investigators (prescribers) that there was no supporting evidence that suggested paroxetine could induce suicidal ideation. The study was double-blind so the patients and investigators didn't know what drug was being used.

Today, on the GSK Study Register website we see that since the study completion, GSK broke the code (so they could see what patient took what drug). They admit to having one suicide in the paroxetine group and one in the fluoxetine group. What they don't do, and they've had 25 years to rectify, is show us what drug caused the suicide attempts. According to the findings, we see no attempts in the paroxetine group and 2 (one completion) in the fluoxetine group. This would suggest that they also broke the code for the suicide attempts but only showed 2 (both in the fluoxetine group) when the documents obtained from the TGA show that there were 7 attempts when 63 patients were enrolled and 9 attempts when the enrollment reached 100.

The 356 Study that sits on the GSK website today doesn't really raise any red flags in its current format. With documents I've published today should we have a need to be concerned?

It is unknown in what group the non-fatal suicide attempts occurred. For all we know they could have all occurred in the fluoxetine group. I'm unsure why GSK have omitted such important data but I can speculate.

It leaves me wondering that if such a trial was carried out today, would the review board still claim there is no link between either paroxetine or fluoxetine and suicidal ideation?

Since the year of this #356 study (1993) GSK has paid $390 million for suicides or attempted suicides said to be linked to paroxetine. This has included an average of $300,000 to resolve 300 attempted suicide cases and an average of $2 million for 150 suicide cases. (Source)

The most recent paroxetine suicide case involves former corporate lawyer Stewart Dolin, whose life ended when he jumped in front of a Chicago Transit Authority train on July 15, 2010, while taking a generic version of Paxil. On April 20, 2017, an Illinois federal jury found GSK liable for Stewart Dolin’s death and ordered the pharmaceutical company to pay $3 million to Wendy Dolin. However, on August 22, 2018, the Seventh Circuit Court of Appeals overturned the verdict claiming, "GSK had presented sufficient evidence time and again through the proceedings – before, during and after trial – to demonstrate it had no control of the drug labeling at the center of the case. Therefore, they said, the lawsuit should have been dismissed." Further, they added, "Court judges erred when they allowed to go to trial a lawsuit brought by Stewart Dolin's widow (Wendy Dolin)"

By 2000, Eli Lilly had reportedly paid more than $50 million to settle more than 30 Prozac (fluoxetine) lawsuits related to murders or suicides. There were also undisclosed settlements. While Prozac suicide lawsuits spiked in the 1990s, Lilly faced less litigation after the drug lost patent in 2001 and generics flooded the market. An FDA-required black box warning for suicide ended all “failure to warn” lawsuits. (Source)


Bob Fiddaman

Special thanks to 'Kathy' of the Australian Antidepressants Class Action & Awareness Facebook Group

Kathy is also an administrator for the Australians For Safe Medicines Facebook page.

She is now in the process of requesting suicide information from Venlafaxine trials in Australia.





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