Seroxat UK Litigation Day 1

Today was an interesting day regarding litigation against GSK and its brain pellet, paroxetine.  GSK markets this product as Seroxat in the UK and Paxil in the US. It is also sold by GSK using other names to include Aropax n Australia and New Zealand. It's likely that pharma companies benefit by giving the same product different names in various countries because it makes it more difficult for consumers to search for and find relevant adverse drug effects as experienced by users across the globe. The average Aussie likely had no idea that Aropax is Paxil in the US, etc.

But back to the paroxetine court cases. Today the Supreme decided to hold off making their decision regarding the Dolin case. A previous case, Merck, Sharp & Dohme Corp. v. Albrecht has similarities to Dolin v GSK. That is, Merck's defence, like GSK's is that the FDA is responsible for changes in the labelling and not drug companies.

In the Dolin vs. GSK case, a Chicago court found in favour of Wendy Dolin in 2017. Not only did the jury determine that GSK failed to warn of the risks posed by paroxetine, they determined paroxetine caused Stewart Dolin's suffering and demise. An Illinois Seventh Circuit court later overturned the jury's decision and that decision was appealed to the Supreme Court where it now remains. It's never easy going up against GSK, despite the fact that they are officially criminals (See The United States Justice Department). I assume that the Supreme Court has decided to hold their decision on Dolin v GSK until the Merck matter is sorted.

Here in the UK, the long-awaited group action trial against GSK kicked off more than a decade after it was filed. The trial is estimated to last three months. I am one of more than 100 plaintiffs and will not be reporting on the trial just yet. But, stay tuned because I'm certain there will eventually be much to say when the dust settles.

As many of you know, I've been writing about GlaxoSmithKline and Seroxat for more than 13 years. Restrictions prevent me from writing about the current trial but I can still write about GSK's not-so-pretty sordid history, which I intend to do over the coming three months.

I will be attending some of the trial and will surely take notes because one never knows if there's another book I might write, my previous book, The Evidence, However, is Clear, the Seroxat Scandal, is quite old now and much has happened since I wrote it some 8 years ago.

For all of those who have contacted me today, these are the reasons why I am not covering the case as it presently unfolds.

It's frustrating given that Truthman and I likely know more about GSK's shady business and their Seroxat-labelled brain pellets than anyone else on the planet.

For now, we will both remain silent.

For now.

Bob Fiddaman.

GSK Study 356 - The Truth is Out - 25 years Too Late!

Regular readers of the Fiddaman blog may have been keeping a close eye on an old study from the early 90's (08 Apr 1993 – 25 Oct 1994) that I've recently found via GSK's clinical trial registry website.

The study, known as GSK Study 356, reported 7 suicide attempts (2 of which were completed suicides). However, these attempts at suicide are not mentioned within the documents GSK has made public. Moreover, the actual number of suicide attempts in Study 356 was 9. (2 of which were completed suicides)

How do we know this?

Documents obtained from the Australian drug regulator, the TGA, show us this but strangely do not tell us in which group the attempts at suicide occurred...until now.

For those who are unfamiliar with the study, it was, to my knowledge, an attempt at finding which of the two antidepressants, namely Prozac and Paxil, were better at treating major depression. The study was sponsored by GSK.

After posting two blogs on the subject, GSK Study ID - 29060/356 - The Missing Suicide Attempts and No Action to be Taken Against GSK for Hiding Suicide Data, the TGA have written to me in efforts to clarify what was revealed by me last month.

However, rather than trying to add clarity to my previous two blogs, the TGA has opened a pretty big can of worms.

In asking them why GSK failed to report the missing suicide attempts they told me the following. It makes for very interesting reading.

Good Afternoon Mr Fiddaman

I have followed up your enquiry about the presentation of information about the Clinical Trial - GSK Study ID - 29060/356 on the GSK study website.

The nine events you have referred to were discussed with investigators at a meeting on November 26th 1993, whilst the study was still ongoing and blind.  Seven of those same events were also included in the Dear Investigator Letter which went out to investigators in August 1993. Of the nine events that were discussed with the investigators five events were subsequently coded to the WHO preferred term of drug abuse, through the methodology applied at that time. On the trial summary these are presented as cases of “Drug Abuse (Overdose)”. There were two of these recorded for paroxetine (patients 139 and 147) and three of them recorded for fluoxetine (patients 18, 76 and 144) 

The remaining four cases were coded to the WHO preferred term of “Suicide Attempt”. On the trial summary two of these events are listed as “Suicides” (in the fatal SAE section) with one for paroxetine (patient 92) and one for fluoxetine (patient 122). The two other cases are presented as “Suicide attempt”, both for fluoxetine (patients 87 and 142).

The information as presented in the clinical trial summary accords with the safety information as provided in the full study report.

I trust that the information provided is of assistance.

Regards

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

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia

--

So, there you have it, folks. The missing suicide attempts were coded as "drug abuse." They did this, according to the TGA, because this was the preferred term, at the time, used by the World Health Organisation (WHO)

So, breaking down the 9 who attempted suicide we have 6 from the Prozac group and 3 from the Paxil group. (1 patient from each of the groups completed suicide)

It's a head-scratcher for me - why would WHO use such a system?

The medical definition of "suicide attempt" and "drug abuse" differ somewhat.

Suicide Attempt
A non-fatal, self-directed, potentially injurious behavior with an intent to die as a result of the behavior; might not result in injury

Prescription Drug Abuse
Taking medication in a manner or dose other than prescribed

This begs the question: How many other GSK sponsored studies buried suicide attempts in the drug abuse category?

Study 356 was carried out in the early 90's. By the late 90's there was growing concerns regarding Prozac, the concerns surrounding Paxil came later.

Here's a Guardian article from 1999. I'll just post the sub-heading and the link:

It was too good to be true. Prozac, the wonderdrug hailed as the answer to the war against depression and taken by some 37 million people worldwide, is not as harmless as we've been led to believe. Disturbing evidence has now emerged, showing that, after the initial relief and euphoria of the first dose, Prozac can push some patients into so agitated a state of mind that they are a danger not only to themselves, but to others, too. (Full Article)

One has to remember here that Study 356 was sponsored by GSK, the manufacturers of Paxil who, at the time, wanted Paxil to be the blockbuster drug that Prozac already was.

Would doctors have prescribed Prozac knowing that there was a high ratio of suicides in a clinical trial - personally, I think they would have. The marketing for these two drugs was heavy and included incentives for doctors to prescribe them. Eli Lilly reps dining and dashing', whilst GSK reps would persuade doctors at strip bars, amongst other places.

Now we know. It's taken the best part of 12 months to get to the bottom of this study, a study that is almost 25 years old!, and I couldn't have done it without the help of 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.

Special thanks to the TGA too. They seem a little bit more transparent than their counterparts, the FDA and MHRA.

The British, American, and, indeed, Australian media are disinterested.

Bob Fiddaman

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

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.

Under Cover Terrorists

There's so much hatred doing the rounds lately - I guess it takes an act of violence on children, innocent children, to get people riled.

And rightly so.

Terrorist Salman Abedi, who carried out the abhorrent act in Manchester two nights ago has been condemned by many. He walked into a foyer knowing what he was about to do, he did so because, it is believed, he had taken the written word from an ancient scripture literally. He probably believes that his actions will be rewarded by some fairy in the sky. "Here you go, Salman, here's some virgins for you, great job."

Many people, including friends and family, hang their hat on the mythical, Let's face it, there's no concrete evidence that God, any God, exists, yet we see throughout history how many atrocities have been carried out in the name of God.

Personally, I'm an atheist. As such, I avoid being manipulated by indoctrination of fairy tales. Not having a God in my life suits me just fine.

The world I move in has seen many child killers, but the public apathy suggests it's okay to kill children and, indeed, adults, if the perpetrators are multi-billion dollar industries.

During the past two days Facebook has seen people voice their shock and horror over the Manchester atrocity. Folks who normally post photos of what they are about to eat or weather updates have been so shocked and moved that they have voiced their opinions and condemned the actions. The Manchester atrocity was enough to get people enraged.

What if I told you that back in 2012, a white coach driver by the name of Geert Michiels carried out an act or terrorism? What if I told you he had no affiliation to any terrorist cell? Michiels deliberately drove his coach into a tunnel wall killing 28 passengers, 22 of whom were children. Would you still be inclined to vent your outrage on Facebook or any other social network?

Geert Michiels, 34, didn't have a weapon of destruction strapped around his body, but he was driving one.

But hey, he had no motive, no indoctrination, no manipulation of the mind... or so we are led to believe.

What if indoctrination came in the shape of a pill, what if that pill changed your outlook on life, on society as a whole? Wouldn't such a pill be snapped up by terrorist organizations such as those responsible for the events in Manchester? If one can manipulate the mind of a 22 year-old by preaching quotes from an ancient book then such a gift as one simple pill could speed up the process of manipulating someone who was once normal into a mass killer.

A full investigation into the coach crash was carried out by Swiss Chief Prosecutor Olivier Elsig, the results of which were inconclusive. He ruled out the involvement of a third party, shortcomings in the road surface or the tunnel infrastructure. Excessive speed, alcohol or technical problems with the vehicle were also ruled out. He, at no point, could determine whether or not Geert Michiels carried out an act of homicide/suicide with the vehicle.

From the investigation, and subsequent independent investigations, it was learned that Michiels was taking or withdrawing from Seroxat at the time of the crash. Seroxat is better known as Paxil in the US and Canada and Aropax in Australia.

It's become widely known that Seroxat can cause suicidal thinking in some people who take it, it has also been proven, in US Courts, that Seroxat was responsible for, not only suicide but homicide too.

Seroxat, by the manufacturers own admission, can cause a symptom called akathisia, in a nutshell, akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Seroxat was Geert Michiels 'bomb'. The drug caused adverse reactions that triggered a series of events in his brain. It was his indoctrination by proxy that eradicated his normal empathy and induced atypical thoughts of killing his passengers and himself. This became his mission in a split second. We know from the recent Dolin Vs. GSK trial that akathisia can be switched on and off in a second. We also know that for persons experiencing akathisia death can be a welcome result. This statement was made by Dr. Roger Lane who, in a 1998 article on akathisia, said, "It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation than patients feeling that 'death is a welcome result' when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders." - At the time, Roger Lane was working for pharmaceutical giant, Pfizer.

Pfizer make Zoloft, an akathisia-inducing drug.

Yet we see no world-wide condemnation of pharmaceutical companies or indeed those who are supposed to regulate the drugs you and I take.

22 people died in Manchester. - Salman Abedi's mind has been manipulated by indoctrination.
28 people died in Sierre. - Geert Michiels' mind had been manipulated by Seroxat.

I anticipate that Facebook posters won't be spreading the Sierre story far and wide.

Bob Fiddaman

Back stories

Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?

Sierre Bus Crash Revisited

Did the Sierre Bus Driver Have a Pre-Disposition to Seroxat?

What is akathisia?

Advocates Against Prescribed Akathisia

Guest Post: Let's Bring Akathisia Out of the Darkness

Disdain Shown Toward Kids by Australian Medicines Regulator

dis·dain
noun

the feeling that someone or something is unworthy of one's consideration or respect; contempt.



So, Australia, a country I hold dear to my heart, apparently has a limp-wristed regulator in charge of it's drugs. Here's a news story from TodayTonight, a current affairs show broadcast in Adelaide, Australia, that may shock you. It was aired on Thursday May 4.

I can't find the words.

I know how Aropax (more commonly known as Paxil and Seroxat) can screw with your head. I know how it can make you feel like you want to kill yourself. I know the horrific withdrawal effects can make you feel like punching walls, and even people.

I know how GlaxoSmithKline wanted children to take it.

Also featured in this video is the story of a young girl who took Zoloft. Pfizer, it's manufacturer, don't seem to mind if kids take their drug either.

I honestly have never known an industry as sick as this one. It's difficult to put in to words because there seems to be such an incestuous relationship with pharmaceutical companies and global regulators. This relationship grows yearly and, it appears, not one medicine regulator seems to give a damn about children (as depicted in this video segment) being prescribed mind-altering drugs that aren't safe for adults, let alone 5 year-olds!

For more information on the SSRI problem in Australia join the Australian Antidepressants Class Action & Awareness Facebook group.

Bob Fiddaman

Seroxat (Paxil) and Noise Intolerance

Hyperacusis is a condition that arises from a problem in the way the brain’s central auditory processing center perceives noise. Common causes include, but are not limited to, ear damage from toxins or medication.

During my time on GlaxoSmithKline's Seroxat I noticed I could not tolerate sounds that I used to be able to tolerate. Sudden loud noises not only startled me but they made me feel agitated. This problem continued through the whole withdrawal process of Seroxat and still exists today. I wouldn't say that my condition is hyperacusis as many of those who suffer from that particular ailment have difficulty with every day noises, such as;  running tap water, riding in a car, walking on leaves, dishwasher, fan on the refrigerator, shuffling papers.

I would, however, suggest, that Seroxat, known as Paxil in the US and Canada and Aropax in Australia, does something to the central auditory processing center as many people have experienced an intolerance to sudden loud noises during their time on Seroxat, withdrawing from Seroxat and years after taking it.

For me, it's sudden loud noises - an example would be a busy restaurant or coffee shop, the clinking of crockery or the clogged filter from the coffee machine being banged. Babies crying on public transport is also troublesome for me. Ironically, I love music so people may say why can you tolerate the likes of AC/DC yet cringe at the sound of breaking glass or random banging? Well, the answer is simple, music has a beat, a rhythm, I kind of know what is in store.

In my book, The evidence, however, is clear, the Seroxat scandal, I describe an incident with my three children and nephew. It relates to the noise issue associated with Seroxat and is something that I found extremely difficult to write about. Basically, my three children and nephew were being boisterous, as kids are, whilst playing on a games console - I told them to keep the noise down - they didn't. I flew into a rage, swore at them and told them to get out. Directly after this incident I went walking through a country park - my intention was to seek confrontation.

Maybe I have a mild form of hyperacusis, one that will, seemingly, stay with me for the rest of my life - a condition I never had before taking GlaxoSmithKline's antidepressant.

With this in mind I reached out to some forums on Facebook where Seroxat patients discuss the problems they face, and have faced, whilst taking Seroxat.

I asked the following...

Has anyone ever suffered with an intolerance to sudden loud noises when withdrawing from Paxil/Seroxat/Aropax and has this intolerance continued after you successfully tapered from Paxil?

Unsurprisingly, I got a good response.

Here's some of the replies that are followed by GlaxoSmithKline's 2014 product monograph for Seroxat. A product monograph is what your doctor gets to see but you don't. Here's some comments first...

I'm still on Paxil and trying to slowly taper, but I can tell you though when I have been in withdrawal all the noises seem to be intensified and I jump out of my skin when anything bangs. I have children so it's very difficult , their sudden tantrums can send me in a spin. I think I'm more on edge with noise and other things since tapering. I'm not off them yet and it's going to take a long time till I'm finished. ~ Giovanna Lee - Sydney, Australia

I became intolerant but it wasn't only loud sudden noise.  For me, even the sound of the toilet flushing sounds like an aeroplane, it gets on my nerves so bad and makes me really angry. I actually had my brother by the throat because he kept running the hot water and the sound of the boiler firing up sent me into a rage. Loud music is really bad as well the neighbours playing music or cars passing makes me wants to throttle them. I have bad insomnia but even when I do sleep the slightest noise wakes me up and really upsets me. I was on Seroxat for 15 yrs and looking back noises irritated me whilst on it but became much worse when I started to wean. I have been off it for 10 months and still hate noise but I don't actually so violently towards it now. ~ Anne Marie McMillan, 47, Scotland

If someone knocks on my car window, I've been known to hit myself in the face when they're out of sight, the same if someone makes me jump. My mum is deaf in one ear so she talks rather loud, sometimes I have to go into the toilet to dig my nails into my palms as a distraction then calm down. It can also be chatter in a supermarket, packaging being handled, gates opening etc. I know we all get distracted by noises, but the rage I feel really worries me. ~ Jane Teece, 52, East Sussex

I didn't notice that I was sensitive to loud noises at first, it is especially sudden loud noises that make me anxious and jittery, when I was on Seroxat it was hard to wake me up and I would sleep through the alarm clock. Off it now for 2 years 4 months and it has caused so many arguments with husband & family members, when sudden noises happen they make me anxious and verbally aggressive and I go into the fight or flight mode, it's as if I'm on high alert and everything is amplified and I'm on edge, it is only recently that my husband has stopped using the alarm due to the issues I was having with it. ~ Julie Anson-Boynton, 46, West Midlands

What I can remember is that when I tapered down from 20mg to 10mg too fast loud noises made my whole body shake. I did not know that this was due to withdrawal, thank God I know a lot more now. ~ Miranda Springer, 43, Holland

Sudden noises during withdrawal but as withdrawal didn't work with me after three attempts, the anxiety of sudden noises (not necessarily loud) have been left with me i.e. thunder, a tap on the shoulder, someone saying my name unexpectedly, car/bike backfire, balloons, fireworks .. the list goes on. ~ Anon, UK

I am in the middle of a pretty significant wave right now and the noise thing is really bothering me. I keep turning the tv down and startle to any noise ie; Kids dropping a fork. ~ Jodie Chinn

Now to Glaxo's product monograph which I spoke about at the head of the patient comments. Glaxo are careful not to let us know if the side effects happened during withdrawal. They also cover themselves by claiming, "It is important to emphasize that although the experiences reported did occur during treatment with PAXIL®, they were not necessarily caused by it."

Events Observed During the Clinical Development of Paroxetine.

Special Senses

• Ear pain
• Otitis media (a group of inflammatory diseases of the middle ear)
• Tinnitus (the perception of noise or ringing in the ears)
• Hyperacusis (a collapsed tolerance to usual environmental sound)
• Otitis externa (inflammation of the outer ear and ear canal)
• Deafness

I bet your doctor never told you about these adverse events related to Seroxat, huh?

Why would he/she? The product monograph for Seroxat is 57 pages long, we surely don't expect doctors to read all of it, do we? In any event, Glaxo make it crystal clear, "It is important to emphasize that although the experiences reported did occur during treatment with PAXIL®, they were not necessarily caused by it."

Furthermore, those limp-wristed medicine regulators, the MHRA have had 36 yellow card reports regarding paroxetine and hyperacusis - see page 11/67

David Healy's RXisk website database shows 163 reported events for hyperacusis, which has a Proportional reporting ratio (PRR) of 15.6% (Link)

So, folks, the next time you jump out of your skin because your child is playing noisily or someone drops a plate on the floor or bangs a coffee filter against a metal container to unclog it, just remember that Glaxo are aware of these problems but claim that they were not necessarily caused by their product.

The Glaxo mission statement has never changed, it's still, "At GSK our mission is to improve the quality of human life by enabling people to do more, feel better and live longer."

GlaxoSmithKline, doncha just love them!

Special thanks to those who took time to email me with their stories. Apologies to those who never made this blog post.

Bob Fiddaman.

Radio Interview - Paxil/Seroxat Related

The interview with me kicks in around the 4.30 mark.

It can also be downloaded here.

Bob Fiddaman.

Glaxo's Paxil Kids Down Under

It's not uncommon to think that only in America lawsuits against pharmaceutical companies are filed, settled and/or won. For many years I was under the impression that it was nigh on impossible to get GlaxoSmithKline into court in the UK. Stumbling blocks, legal wrangles and funding just being some of the hurdles those of us involved in the UK group action against GSK have had to endure over the past ten years or so. Thankfully, against GSK's wishes, the group has now been granted access to trial by the presiding Judge (Back Story)

So, what about other countries? We rarely hear of pharmaceutical companies getting hauled in front of Judges outside of America (and now the UK)

Canada, for example, sits on the border of America yet, to my knowledge, no class action lawsuit has ever been brought against any pharmaceutical company where antidepressants are concerned. Maybe I'm wrong or maybe the Canadian media just don't want to report on any such action?

Step forward Australia. A country I hold dear to my heart.

Drayton Sher, a Sydney based law firm,  are now working on a group action on behalf of people who, as children and adolescents, were prescribed the antidepressant drug paroxetine, known as Aropax in Australia.

It's a brave move and they should be applauded.

Aropax, which is known as Seroxat in Europe and Paxil in the US and Canada, has been the subject of many lawsuits ranging from it inducing suicide, homicide, birth defects and severe withdrawal reactions for a large number of people who have taken it.

The proposed class-action lawsuit comes on the back of recent findings that Glaxo played down the risk of Aropax use in children.

Last September a damning reanalysis of GlaxoSmithKline's infamous Study 329 went public. (Back story)

The original 329 study showed that...

"Paroxetine is generally well tolerated and effective for major depression in adolescents."

However, after reanalyzing the study, it was found that the claims and subsequent support of the claims were misleading and, in actual fact, false.

Glaxo have remained tight-lipped regarding 329 for many years, on the odd occasion (slip-up) they have drawn attention to the abhorrent scale of those who could have been at risk but, as usual, those risks have either been spun or played down.

In 2003, GSK's then Head of Psychiatry, Alastair Benbow (pictured above) went on national television and claimed that, "less than a small class size would have these suicidal thoughts." 

For those of you interested in Benbow's actual class size please feel to read Alastair Benbow: The Devil is in the Details - it makes interesting reading.

In the meantime, Glaxo will no doubt defend the allegations. The Sydney Morning Herald reached out to them for comment. None was forthcoming.

Drayton Sher can be contacted here.

A Facebook page has also been created where you can learn more about other lawsuits in the pipeline - here.


Bob Fiddaman.

Give Them Hell, Brisdelle

Back in 2013 I wrote about the FDA's approval of an apparent 'new' drug to treat hot flashes during menopause.

The perfectly pink packaged Brisdelle is now being shown on US TV screens, a marketing strategy aimed, of course, at women.

The 60 second ad avoids telling the viewer that what is actually being advertised is a chemical compound called paroxetine, better known to millions of US citizens as Paxil, an antidepressant with a less than savoury history.

Brisdelle is 7.5mg of Paxil with a new brand name, by adding Paxil to the combination the patient will actually be overdosing.

Another antidepressant, Wellbutrin, is also marketed for different uses, once again under a different brand name - Zyban. For those that don't know Zyban is a smoking cessation drug cum antidepressant - exactly the same as Brisdelle is a drug to treat hot flashes cum antidepressant.

Quite why the FDA granted a licence to Brisdelle knowing what they know about Paxil astonishes me.

Let's watch the 60 second ad... pay attention to what the voice-over says, it follows the words, "Call your doctor if". Then listen to the same voice-over list the three apparent 'played down' side effects..

Tell your doctor if you are allergic to paroxetine?

Quite a spin - it probably means tell your doctor if you have taken paroxetine before and suffered its multitude of side effects, which include; suicidal ideation, completed suicide, birth defects and addiction to name but a few.

Last month Dr Evan Levine wrote a brilliant piece regarding Brisdelle. Levine wrote the column for the Ridgefield Press and made some astute comments.

For me, it’s yet another example of Big Pharma exploiting an unwary public with the phrase “Approved by the Food and Drug Administration.” Brisdelle is the trade name of a drug that has been available for years as a cheap generic, paroxetine, also known as Paxil, now rebranded and sold in a dose that is both convenient for the manufacturer and equally inconvenient for the consumer.

At 12 weeks into treatment, those patients who took this antidepressant (Brisdelle) had, on average, 5.9 fewer hot flashes and those patients who took the placebo had 5.0 fewer hot flashes; again statistically fewer hot flashes for those who took the Brisdelle, but not even less than one fewer hot flashes a day when compared to the nothing-pill. A quick review of the data and you’ll notice that the subjects taking the placebo for three months actually had fewer hot flashes than the patients who took it for a month!

Levine continues with...

And now the most disturbing part. The FDA’s independent advisory committee voted 10-4 not to approve Brisdelle, in March of 2013, on the grounds that it did not provide sufficient benefits. Yet the FDA went ahead and approved it anyway! The FDA rarely approves a drug that has more negative than affirmative votes.

Great observation from Levine.

We can't point the finger at GlaxoSmithKline for this one folks. It's Noven Therapeutics who market Brisdelle.

My advice to women suffering from hot flashes is simple. Stay away from Brisdelle, your reaction to it could cost you your life.

Further reading on the risks of paroxetine here.


Bob Fiddaman.

MHRA CEO, Paxil and Suicide

Much has been said about the conflict of interest between the British drug regulator, (MHRA), and GlaxoSmithKline. It's obvious to those who know the history of GSK and the MHRA that there is a huge conflict of interest that just cannot be ignored and while such a conflict exists patients will not be safeguarded from the likes of Paxil, a drug marketed and manufactured by GlaxoSmithKline.

I've met with the MHRA are a number of occasions, at one stage I offered to help them with their out of date and deeply flawed yellow card reporting system, a system where adverse events are collected and...well, basically nothing is ever done.

Communications between me and their then CEO, Kent Woods, broke down due to his refusal to acknowledge that Paxil, known as Seroxat in the UK, should be classed as a teratogen. A teratogen is an agent or factor that causes malformation of an embryo.

Much of my communication with the MHRA is in my book, 'The evidence however, is clear, the Seroxat scandal' [1]

In 2013 Kent Woods retired and the MHRA appointed Dr Ian Hudson (pic above) as their new CEO.

Hudson, who after leaving Glaxo in 2001, became the MHRA's Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market.

Yup, the man in charge of the agency who have the job of keeping tabs on the drugs you and I take is a former employee of GSK - then known as SmithKline Beecham.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. In 1998 Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife's head, as well as through his daughter's head then through his granddaughter's head before shooting himself through the head.

Hudson's deposition has been online for sometime in text form, a copy of it can be viewed here.

Sadly, it's been difficult trying to obtain the actual video footage of Hudson being depoed by US attorneys representing Tobin.

We do, however, have a small segment of his video deposition.

In 2002 Investigative journalist Shelley Jofre launched her first installment into the whole Paxil debacle. BBC Panorama's 'The Secrets of Seroxat' was aired and it prompted over 67,000 calls and emails from concerned consumers.

During the documentary Shelley touched on the case of  Donald Schell. The footage in the documentary revealed part of Dr Ian Hudson's video deposition. Remember, at the time, Hudson was a GSK employee.

Watch.... (Hudson was depoed in 2000)

**If the video starts with Andy Vickery talking then click the bar to end of video then press play**

In 2008 the MHRA concluded a four year investigation of GlaxoSmithKline, the crux of which was to find out whether GlaxoSmithKline withheld paediatric safety data pertaining to suicide related to its antidepressant Seroxat. They decided not proceed to criminal prosecution. It's unknown if they interviewed their own Dr Ian Hudson during their four year investigation. [2]

As I said, Dr Ian Hudson is now the Chief Executive of the MHRA, the agency that purportedly protects British consumers of prescription drugs.

I don't know about you but this doesn't really fill me with a sense that I am being protected from dangerous drugs. Does it you?

All four Paxil videos will soon be available in their entirety on Rxisk. 

Bob Fiddaman

[1] 'The evidence however, is clear, the Seroxat scandal' [US] [UK]

[2] GSK investigation concludes [Link]

The Bizarre Life of Dr Andy Clayton

 Dr Andy Clayton

Initially I was just going to highlight a segment of a video that featured Dr Andy Clayton [above] speaking about antidepressants and withdrawal. Initially I was going to present him with a 'Burke of the year Award'.

Researching him was easy.

First, here is the segment of the video you should watch. It's taken from the BBC's first Panorama documentary about GlaxoSmithKline's Seroxat. 'The Secrets of Seroxat' was aired in the UK back in 2002. All 4 Panorama programmes about Seroxat will be available soon on David Healy's RXISK website.

Seroxat is known as Paxil in the US and Canada and Aropax in Australia and New Zealand.

Here's the snippet featuring Dr Andy Clayton.

Video also here.

Transcript: [1]

Dr ANDY CLAYTON
Medical Director, Derby Mental Health Trust
They're so simple, you don't kneed to be a genius to prescribe antidepressants and they get 
seven out of ten people better in a couple of months and they're not even very expensive.

JOFRE:  Cheap, effective and apparently even Seroxat withdrawal symptoms can be beneficial.

CLAYTON:  Interestingly I've actually found the withdrawal effect to be quite handy for a few 
people.  I've had several patients who've come to see me in clinic and said: "I actually sort of 
stopped taking my antidepressant doc because I thought I didn't need it.  But after a day or so I 
felt a little twitchy, a little uncomfortable and it made me realise I did need it."

JOFRE:  But wouldn't that just be the withdrawal effect?

CLAYTON:  Well exactly, that's the withdrawal effect that they had noticed for a day or so and it 
had prompted them to go back on the pills which is very helpful.



Very helpful?

I'd not seen 'The Secrets of Seroxat' in its entirety before so, as you can imagine, Dr Clayton's comments startled me somewhat. However, researching Clayton I found something even more startling.

In 2006, some four years after 'The Secrets of Seroxat' was aired, a number of allegations were made against Clayton that dated back many years. After an investigation Clayton was sacked two years later, in 2008.

One year later, in 2009, Clayton appeared in court on charges of  possessing child  pornography.

Judge John Burgess sentenced Clayton to a three-year community order and he was was also banned from working with children under 16 for the next five years. [2]

In 2010 the former joint medical director of Derbyshire Mental Health Services NHS Trust, was removed from the medical register following a ruling by the General Medical Council hearing. This was following his sacking in 2008 where it had been alleged that Clayton, while working at a Swadlincote clinic from 1990 to 2002, was found to have behaved in a sexually motivated and made lewd comments to two patients and a trainee occupational therapist.

The panel was told he also had written a prescription, in January 2009, for a month's supply of an antidepressant for his own personal use, which was a breach of his suspension. [3]

Also, in 2010, a post appeared on a blog entitled, 'Perv Doctor'. The writer alleged the following...

My GP had referred me to this consultant as he was 'a good friend' of his. I didn't much like my GP but I trusted him. My family knew I had self harmed but I was too embarrassed to tell them I had been referred to a psychiatrist.

I went to the appointment alone in a clinic I had never visited before. I went into the room alone and Dr Andrew Clayton and I were alone throughout the appointment. Not once did he ask if I'd like a chaperon He discussed why I had been referred to him and asked me if I was sexually active and how many times a week I had sex. Which I thought was odd.

Worse was to come. He then said that cancer could cause depression and he wanted to examine my breasts. I was horrified but I was young and too polite (??) to object so he examined my breasts. He never talked about treatment, counselling or anything else after the examination and said if I needed to come back to make an appointment or go and see my GP.

I got out of there as quickly as possible with no intention of ever going back. I wasn't about to tell my GP that his friend had examined me inappropriately. I decided if this was the way to treat a depressed teenager then I would have to face it alone and never asked for specialist help again.

I was put on antidepressants a year later after I could no longer cope with the symptoms but had been too scared to go to my GP in case he sent me to a specialist again. I never told anyone about what happened until years later.

On Oct 25, 2012 Clayton was found hanging in his back garden. At the time he was facing fresh sexual allegations [4]

His wife told the inquest that her husband had previously attempted to drown himself in their garden pond two years before his death.

So, it 2002 Clayton claimed that it was "helpful" that patients went back on to antidepressants as a result of suffering withdrawal symptoms.

In 2009 he prescribed himself a months supply of antidepressants.

In 2010 he attempts suicide

In 2012 he completes suicide.

Bizarre.

I don't know about you but I keep playing the 50 second video [above] - I'm quite gobsmacked that a professional could claim that it is helpful for people to go back on to antidepressants as a result of suffering severe withdrawal symptoms while trying to get off them. I know we shouldn't speak ill of the dead but it's when he was alive that I find very peculiar. His whole manner during the 50 second footage is, it has to be said, quite scary. When told by investigative journalist, Shelley Jofre, that these patients may have been suffering a withdrawal reaction to the drug, he agrees but then, in a bizarre jovial manner, claims the withdrawal was helpful because the patient returned to the antidepressant!

Interestingly, Dr Clayton et al investigated a possible link between antidepressant use and self harm in 2000. The study, entitled, 'Deliberate self-harm and antidepressant drugs - Investigation of a possible link', appeared in the British Journal of Psychiatry [5]

Clayton et al found that prescribing safer-in-overdose antidepressants is unlikely to reduce the overall morbidity from deliberate self harm.

The study  received an "unconditional contribution" from Prozac and Cymbalta manufacturers Eli Lilly and... you've guessed it, Seroxat manufacturer, GlaxoSmithKline.



Bob Fiddaman.


[1] The Secrets of Seroxat

[2] Another Derbyshire doctor caught with child porn

[3] Derbyshire doctor struck off over harassment claims

[4] Suicide of psychiatrist facing sex crime claims after child porn shame

[5] Deliberate self-harm and antidepressant drugs- Investigation of a possible link

Brazil Suspends Sale of GSK's Paxil (Seroxat)

The National Health Surveillance Agency (ANVISA) have temporarily suspended the sale of GlaxoSmithKline's antidepressant Paxil.

ANVISA are the Brazilian drug regulatory agency who regulate the drugs Brazilian citizens are prescribed.

GlaxoSmithKline sent ANVISA correspondence stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues.

It's unknown where the contaminated batches originated from. The batches recalled are:

SH0040V (manufacture date, June 2013, and expiration date, June 2015),
RK0084V (manufacture date, August 2012, and expiration date, August 2014),
RJ0220V (manufacture date, July 2012, and expiration date, July 2014),
RJ0219V (manufacture date of July 2012, and expiration date, July 2014),
RC0113V (manufacture date, March 2012, and expiration date, March 2014)
RC0113V1 (manufacture date, March 2012, and expiration date March 2014).


Last month GSK Ireland were sent a warning letter from the FDA listing a series of violations regarding the state of their plant in Currabinny, Carrigaline, Cork. Paxil had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

Back in 2010 Glaxo plead guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.


Bob Fiddaman

Email to GlaxoSmithKline Regarding Paxil Birth Defects

Dear Ms Moniz,

My name is Bob Fiddaman. I am the author of 'The evidence, however, is clear, the Seroxat scandal' and the blog 'Fiddaman Blog'.

A short time ago I was contacted by Ms Joanne Thomas of Pennsylvania. She presented me with an email and attachment that you sent her, namely case number A0348482B.

I have wrote about Joanne's case in two articles, both of which have now had over 6,000 views between them.

I 'd like to ask you a few questions, if I may?

• When your company, in an internal email, suggested that Paxil was the probable cause of Joanne's fetus developing heart defects, why didn't they disseminate this information to Joanne?

• When your company learned that Paxil was the probable cause of Joanne's fetus being born with heart defects, why didn't they inform the FDA?

• When your company learned that Paxil was the probable cause of Joanne's fetus being born with heart defects, why didn't they alter the labelling on the Paxil Information Leaflet?

• Joanne's case against your company was lost on the basis of the Statute of Limitations defence your company lawyers, King & Spalding, they used. However, we both know now that Joanne was well within the limit when she first wrote to your company - what is your company's position on this?

• Why has no apology ever been made to Joanne Thomas?

I'm sure you will run this past your superiors who will, more than likely, run it past King & Spalding. Before you do, I ask you to read the two articles and show some compassion, you are, after all, a woman yourself.


A copy of this email will go public in the near future.

Here are the two articles I wrote. Part II features your email to Joanne.

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists


Sincerely

Bob Fiddaman.

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Joanne Thomas - Paxil Birth Defects Mom

Continuing on from Part I...

In brief, Joanne Thomas filed a Paxil birth defect lawsuit against GSK in 2006. GSK argued that she was out of time. [Statute of Limitations] The Judge and subsequent appeal panel agreed with GSK.

What I am about to show you should have been brought to the attention of the Judge and the appeal panel. Joanne's law team, unfortunately, didn't join the dots - that was left for myself and Joanne to work out.

Before I present this new [unseen] evidence it's important to know that GSK had a golden opportunity to warn the public about Paxil's propensity to cause birth defects. The following evidence, almost verbatim, was taken from the Kilker v GlaxoSmithKline birth defect trial. A trial that saw the jury find Paxil responsible for causing the birth defects in Lyam Kilker.

A long, long time ago, as they say, Glaxo purchased the compound [paroxetine] from a Danish company called Ferrosan. Ferrosan had done the preliminary animal studies to look at teratogenicity. Study 295 saw Ferrosan give Paxil to pregnant female rats. The rats who didn't get Paxil [they were given nothing] 12% of the rat pups were dead by the fourth day after they were born. However, and here's the important bit, the rats that were given Paxil [5mg] 65% of the rat pups were dead by day 4. The ones that were dosed with 15 milligrams of Paxil, 92% of the rat pups were dead by day 4. And those given 50mg of Paxil... all the rat pups died.

Armed with this information Ferrosan, after selling the compound to GSK, then SmithKline Beecham, wrote a memo in 1980 telling GSK about the study and the high risk of embryolethality [dead fetuses]

What did Glaxo do with this information?

Well, they sat on it.

Step forward to 1994. Paxil was doing great, it was a blockbuster. 'Ka Ching' was echoing around the corridors of GSK. Glaxo, being the money-making corporate company that they are, wanted more sales though. America wasn't enough. So, they decided to target Japan. One small problem though. The Japanese have big issues when it comes to birth defects, they've seen their fair share of them over the years what with environmental disasters such as Hiroshima, Nagasaki and Minamata. If the Japanese found the Ferrosan study then that could have affected GSK's American market.

So, how could they [GSK] hide the rat pup studies from the Japanese? Well, they designed a study for them but it was a study that would have serious implications for GSK and Paxil. They autopsied one of the rat pups, hazard a guess at what they found?

One of the pups was found to have an edema, swelling around the heart, and it had a ventricular septal defect.

Now, one would have thought at this point that this particular finding would have caused alarm bells to ring. 

Not so.

They minimized it. In their conclusions they didn't even mention it. It is buried in the back of the study in an appendix.

My question is pretty simple. How can GlaxoSmithKline's lawyers argue that Joanne Thomas was late in filing her action and that her unborn son was non viable when they knew many, many years before Joanne fell pregnant with Ryan, that Paxil could cause birth defects in rat pups? They knew, the consumer didn't. How can they blame the consumer for not knowing?

Furthermore, even if Joanne did find out at the time that she was taking Paxil that it was dangerous to her unborn child, how did GlaxoSmithKline's lawyers expect her to just stop taking it when Paxil has one of the highest incidents of withdrawal rates in the SSRi group of medicines? 

Glaxo quietly settled a previous Paxil addiction lawsuit in the US back in the mid 2000's with over 3,000 claims against them.

Now Here's Twist Number One

As I mentioned above it came to light during the Kilker trial that Glaxo knew very early on that Paxil was causing rat pups to die and also causing heart defects. That was clearly established in the trial.

Also, during the Kilker trial it came to light, via GlaxoSmithKline internal emails, that Glaxo had been contacted by a consumer in 2001. Many lawyers and advocates have, for years, being trying to track down this woman. Sadly, no name was attached to the emails. Glaxo were afforded the privilege of removing the name, probably for 'data protection' reasons.

Here's the emails that were sent to Glaxo in 2001

"I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I've been taking Paxil, which is truly a miracle drug. I've been panic-free with this drug and have been able to go on with a normal life.

"I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

"The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time).

"To say the least, I was absolutely distraught with this news. I thought this was something that I did [...] because I stayed on the Paxil for selfish reasons.

"I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies.

"My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don't want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

"Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.

"Please contact me as soon as possible ... Please don't forget about me."



The woman sent a second email, on 1 June 2001.


"This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

"I am in no way insinuating your product did this to my child. I love the product, and I don't think I could have gotten through my panic attacks without the wonderful help of this miracle drug.

"I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

"Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help."

The following GSK internal memo from June 2001 refers to her emails.

"Report 2001014040-1 describes the occurrence of a terminated pregnancy in a female of unknown age prescribed paroxetine (Paxil) for panic disorder.

"This report was received from the patient and has not been confirmed by a physician or other health care professional. Concurrent medications and medical conditions were not known.

"Four-and-a-half years ago, the patient started Paxil (dose unknown). Since taking Paxil, the patient noted she has been panic-free and has been able to go on with a normal life.

"Patient discovered she was pregnant in December 2000 while being treated with Paxil. However, she reported that at six months gestation the pregnancy had to be terminated because the fetus was diagnosed as having Truncus arteriosis.

"Her physician told her that the child would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered, if he was able to make it to that time."

GSK emailed the following response to the woman on 6 June 2001.

"Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy.

"Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.

"Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.

"We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

"Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department ..."

But an internal GSK internal document relating to the correspondence, headed "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

So, an admittance by GSK that Paxil was related to the birth defect, right?

The mystery woman, whose name was redacted on the documents presented at the Kilker trial, has been the subject of much debate ever since the emails were made public. Just exactly who was she?

Professor David Healy, who actually gave evidence in the Kilker trial, has tried hunting her down in two excellent posts of his, American Woman and American Woman 2. I'd even wrote about the mysterious woman in my book, The evidence, however, is clear, the Seroxat scandal.

For the first time I can now reveal that the mystery woman was Joanne Thomas, mother of the "non-vialble fetus". The same mother who has been told she cannot pursue her complaint against GSK because she is out of time [statute of limitations]

It makes a mockery of the law, don't you think?

• File an adverse event to a pharmaceutical company.

• Have that very same company admit via internal emails to one another that Paxil was the cause of the adverse event.

• Have no feedback from that same pharmaceutical company, despite asking them if Paxil is safe to take during pregnancy.

• Learn six years down the line that Paxil has been classed as a teratogen.

• File suit against the company for causing birth defects.

• Have the pharmaceutical company attorneys tell you that you are out of time.

Talk about having your cake and eating it!



So, in 2001, GSK received one spontaneous report from a mother who had terminated her pregnancy, this mother was taking Paxil at the time she terminated because her fetus was deemed to have  a rare congenital heart disease.

Why, at that point, didn't GlaxoSmithKline, change the product information labelling on Paxil?

More importantly, how can GlaxoSmithKline argue that Joanne Thomas is out of time to file a case against them [statute of limitations] when, it could be argued, that she already made Glaxo aware of her son's birth defects back in 2001?

I'd love to know if Glaxo handed over full disclosure to the attorneys representing Joanne Thomas?

Glaxo corresponded with Joanne via emails back in 2001, did they present these emails to Joanne's attorneys, if not, why not?

Twist Number Two

Glaxo had Joanne's name on file, they had it since 2001. Are we to believe that during Joanne's case they didn't know that she was the mother who contacted them back in 2001, the same woman who, through Glaxo's own internal emails, aborted her child because the Paxil  she ingested was almost certainly the cause of the birth defects?

Here's where the case takes a rather bizarre turn.

Reading the the Appellee Brief [GSK] we see that GSK claim that Joanne admitted that she had no contact with GSK until nearly four years after the Statute of Limitations expired on April 26, 2003.

I think it's fair to say that Joanne suffered a major trauma here and one could possibly argue that she cannot remember because of the trauma suffered around the time of her termination.

In any event, why did Glaxo not reply to her with their finding, "almost certain"?

What she has now is evidence that she did indeed contact GSK and they [GSK] knew that she did, although I guess they could argue that they didn't know, that's what King & Spalding are paid to do. Maybe they could use trauma as an excuse or if any of the King & Spalding team were taking Paxil  they could probably use memory loss as an excuse.

It's almost as if GSK have used Joanne's poor memory against her then made her admit to something that they knew would be an untruth as they already had evidence that she had wrote them in 2001.

Internally they blamed Paxil for her termination but never told her this. That, by anyone's standards, is fraudulent concealment, isn't it?

It's Glaxo that failed to act and not Joanne Thomas. The only course of action Joanne took was to terminate her pregnancy, a termination that Glaxo are now arguing was of a non-viable fetus, in other words Ryan, the unborn fetus, was not really a living being in the sense of the word, the word according to Glaxo and Pennsylvania law.

The internal documents, remember, revealed that Glaxo were "Almost certain" Paxil caused the birth defects in Ryan. Why, in 2013, twelve years later, are they settling other birth defect cases but refusing to compensate Joanne Thomas for her loss? [The Kilker family received  $2.5 million in compensatory damages]

So, do I, as a writer, just take what Joanne has told me at face value? Of course not, it would be unprofessional to do so. Joanne was unaware that the emails from the Kilker trial had been made public, she was unaware that the video deposition of Jane Nieman, a former GSK employee, had been made public. Joanne and I began to join the dots after reading the emails and watching the video deposition. I asked Joanne to check through her old emails. Joanne, being the astute woman that she is, went one better than that.

On the 10th December 2013, Joanne contacted GSK and spoke with Jacqueline Moniz, a Sr. Clinical Safety Scientist. She asked Moniz for her Medwatch reports. Surprisingly, Moniz emailed them to Joanne within a couple of hours of speaking to her. Here's the cover letter:

Hello Ms. Thomas,

It was a pleasure to speak with you.  Again, I appreciate your assistance with identifying duplicate reports in our safety database.

I have attached a pdf that contains all of the reports.  When we spoke, I did not realize that the last report was not completed to “MedWatch” stage.  It was identified as a duplicate prior to completing the case.  I included the narrative for this report at the end of the other reports.

Please let me know if you require further assistance with these.

Thank you,
Jackie

Jacqueline Moniz
Sr. Clinical Safety Scientist
US CMG & Operations
RD Chief Medical Office

GSK
5 Moore Drive, PO Box 13398, RTP, NC 27709-3398, United States
Email   jacqueline.x.moniz@gsk.com
Tel       +1 919 483 7116

I've seen the documents sent to Joanne by Jacqueline Moniz. The documents reveal Joanne to be the sender of the email used as evidence in the Lyam Kilker trial.

The internal documents that surfaced at the Kilker trial showed that Glaxo officials had stated  "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

The documents sent to Joanne from GSK reveal the same case number.

Finally, as with all deaths, those who are left to pick up the pieces often blame themselves. What if I did this or that, what if I turned a different corner that day, would this still have happened? It's part of the grieving process I guess, although I am not an expert in such matters, the experts are those who have had to endure such tragedies.

Joanne wrote a letter to her child that never was, it's tough to read but she has given me permission to publish here today. The letter sees Joanne apologising to Ryan for terminating him, part of which reads...

"Daddy and I went to a doctor in the city where we would take you out. I was so scared, but I hoped, I prayed that it was the best for you. You kept kicking my stomach and I felt like you were saying "Mommy, don't do this to me". But then I felt like you were saying, "Mommy, let me get home.""


This is for Glaxo and their lawyers. It also serves as a warning to expectant mothers out there, call it informed consent, if you will.

"You kept kicking my stomach and I felt like you were saying "Mommy, don't do this to me""

And here's Ryan...

Glaxo have, in my opinion, abused the law in this case. Sadly, the law, being as perverse as it is, has allowed Glaxo to use it for their benefit. They have, in essence, acknowledged Paxil caused the heart defect which, in turn, forced the hand of Joanne Thomas. But to save money they have used a statute of limitations and a non-viable human excuse as their extraordinary defence. Both arguments are deeply flawed and, maybe, could have been met with a counter-argument such as the ones laid out in Part I -  ( Though still small and fragile, the baby is growing rapidly and could possibly survive if born at this stage.) and (If born now, your baby would have a 20% chance of survival, the odds going up with each passing day.)

Former Glaxo employee, Jane Nieman, provides an insight into the pharmacovigilance at GSK.

In this video deposition she is interviewed by a US attorney who was representing Lyam Kilker [Kilker v GSK] Skip to 31 minutes of this video deposition and you will see both discussing Joanne's emails to GlaxoSmithKline, although at the time Joanne was still the 'mysterious woman'.

I sent the video to Joanne because what she was telling me during our conversations seemed to strike a bell.

As Joanne reviewed the video it became apparent that the woman being discussed by Jane Nieman was actually her.

Joanne flicked me the following email...

"Omg...Bob that's me!!!!
"Jesus Christ 31:07 ... I believe its my call!!
"I am a mess...."

In the space of just 7 days Joanne and I pieced together all the information. Her actual case had been with attorneys for 7 years - Nobody had joined the dots.

Here's Joanne's take on the video.

"They knew all along that Paxil did this to Ryan and yet they never told me or warned any other expectant mother out there.

"I heard that many attorneys had hired Private Detectives to try and hunt me down as they wanted to put a name to the mysterious woman and maybe possibly use me as a witness. 

"Luckily I got in touch with Bob Fiddaman and the mystery was finally solved."

Joanne's father, Mike, added, "When Joanne showed me the information about the "mystery woman" and the trail it brought to light, part of me thought "makes perfect sense for a company like GSK". My daughter and others are morally showing what GSK is."

It sickens me to the core that this woman has been treated so abhorrently by GlaxoSmithKline and the expensive suits team of King & Spalding attorneys hired by GSK.

The FDA failed her and her unborn son too. As for GlaxoSmithKline, they chose to sit on the rat pup studies. If they had carried out further tests, as Ferrosan suggested, then they may have just saved a human life or two. Sadly, to lose such a stranglehold on the American antidepressant market saw them opt out of the transparency they boast about today, a transparency that has TV and media doctors applauding GSK and singing their praises. For what exactly? Those same high profile doctors currently singing the praises of GSK should watch the above video in its entirety. Even when faced with a human birth defect they decide to keep the results "in-house", yet another failure to warn the public about Paxil's propensity to cause birth defects.

Glaxo had a legal duty to revise the labelling for Paxil when they, through their own pharmacovigilance, learned that Paxil was the 'almost certain' cause of the birth defects in this particular case. They didn't. Was this to cover themselves from being sued? It's a fair enough question given the circumstances surrounding the 'statute of limitations' defence used against Joanna Thomas, isn't it?

Furthermore, Joanne emailed GSK with, "My husband and I are ready to try again to get pregnant in the next month or two." Why didn't GSK warn her that their initial assessment resulted in Paxil being the cause of her first child's birth defects? What kind of person would keep this information from a woman?

GSK have a lot to answer for in this case. By simply throwing a statute of limitations defence at it is not good enough. Kudos to their law team for doing their job, bad Karma for the person who decided to go down that route.

No apology has been offered to Joanne Thomas by GSK. No admittance that they had claimed, in-house, that it was 'almost certain' that Paxil caused Ryan's birth defects.


The Appeal, Joanne's Acquiesce

Armed with this evidence Joanne gave me permission to contact her attorneys. After reviewing the evidence they have now filed an appeal in the Supreme Court. Glaxo wouldn't be Glaxo if they didn't object to such an appeal... and they have done so in remarkable fashion.

They, via King & Spalding, are, in essence, claiming that Joanne cannot charge them with fraudulent concealment just because they knew about the Paxil/pregnancy hazard and didn't tell her. In a nutshell they are claiming that  they had no legal  duty to look out for Joanne's interests.

They also claim that they asked Joanne for her medical records and she never replied. Wow! admit internally that Paxil has caused birth defects and then ask for medical records! Seems a kind of half-assed way to conduct pharmacovigilance, don't you think?

In any event, pharmaceutical companies only ask for medical records so they can blame other drugs the consumer may have been taking or, in many instances, blame the illness or genes of the consumer.

I'm left wondering why GlaxoSmithKline have, in my opinion, such a disdain for women who are pregnant?


Buying Silence

In between all the legal wrangling between Joanne's attorneys and King & Spalding a new offer was put forward - the terms of agreement didn't sit right with Joanne. In a nutshell, GSK wanted her to sign an agreement that dissolved them and Paxil from any blame. These agreements are more commonly known as 'gagging orders'. Joanne, after careful consideration, rejected GSK's offer. Had she had signed it then it would have been her acquiesce. She would have not been able to discuss this new evidence with anyone.

Begs the question then if GSK were merely offering Joanne a compensatory award in return for her silence?

Why, if this was the case, would they want to buy Joanne's silence?

I, personally, do not like GlaxoSmithKline. I do not like the lawyers that represent them. I do not like the Pennsylvania law [2 year statute of limitations] or the way that King & Spalding [Glaxo's lawyers] used it to their advantage resulting in heartache for a mother who only ever wanted to hold and love her baby.

This should not be about points of law, this should be about humanity.

GlaxoSmithKline should be bowing down before Joanne Thomas. They should be thanking her for bringing the birth defect link to their attention. Joanne's fetus was, in essence,  part of the study that they should have ran when they learned about the Ferrosan rat studies.

Ryan was the human guinea pig, he was sacrificed to warn others but, yet again, Glaxo failed to warn in time. They argue that they don't have a duty to yet expect consumers to file claims against them in time.

Let's give the little guy some respect here. Let's give his mother, Joanne, some respect too.

I am glad Joanne Thomas made contact with me. I am glad that we were able to join the dots. I'm glad the mysterious American woman who contacted GSK back in 2001 isn't so mysterious anymore. Hopefully, the mainstream press will pick up on this and Joanne will be paid handsomely for any interviews she does in the the future, she deserves it.

Furthermore, Joanne is a  valuable witness, she, to my knowledge, is the only living woman who has evidence that Paxil was almost certainly the reason why her son developed heart defects. She has this in the form of GlaxoSmithKline's own internal emails.

Put a face to the mother who GSK were discussing in emails, put that same face in the witness stand for any future Paxil birth defect litigation and you will have very powerful leverage to strike a deal between GSK and plaintiff.

Litigation isn't about justice - it's merely about striking a deal so that everyone walks away moderately happy.

The Pennsylvania law has failed Joanne here and it has failed her miserably.

GSK's  US HQ is in Pennsylvania. Nice to have their headquarters in an American state that has laws that have supported their argument, huh? Why build an igloo in Jamaica when you can have a more robust igloo in Greenland?

The GlaxoSmithKline company tagline is, "Do more. Feel better. Live longer."

Obviously this does not, and never will, apply to Ryan, the alleged non-viable fetus.


Bob Fiddaman.

Most lawyers know when their clients are guilty of the crime charged, and will work hard to represent them in order to get the best deal possible. There are some, however, who will believe every word their client says, regardless of the videotaped evidence, the confession, and the litany of witnesses who say otherwise. I suppose it relates to maintaining credibility, but if you refuse to accept a cold hard fact, and instead tell an ADA or the judge (or heaven forbid a jury) the complete opposite based only on the say-so of your client, then you are not being effective. A healthy mistrust of the State is, undoubtedly, healthy for a defense lawyer, but blind acceptance or willful ignorance of the facts is unhealthy for a positive resolution of the case. - D.A. Confidential

Glaxo and their attorneys, King & Spalding, can be contacted via Twitter. @kslaw and @GSKUS
References for Part I & 2


(1) Wolfe v. Isbell, 291 Ala. 327, 329 (Ala. 1973)
(2) Coveleski v. Bubnis, 634 A.2d 608, 610 (Pa 1993).
(3) McCaskill v. Phila. Housing Auth., 615 A.2d 382, 384 (Pa. Super. Ct. 1992) (following the U.S. Supreme Court’s holding in Planned Parenthood v. Casey, 505 U.S. 833, 860 (1992), that viability occurs at 23 to 24 weeks).


Bob Fiddaman

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