Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, June 29, 2013

FDA Approve Re-badged Paxil for Hot Flashes

Paxil comes in all shapes and sizes

Those 'wise' folk over at the FDA in the US have gave the thumbs up for a new drug that's hit the market.

Brisdelle, marketed by Noven Therapeutics, LLC, is in fact a low dose of Paxil [Known as Seroxat in the UK and Aropax in the southern hemisphere].

The drug, which apparently treats moderate to severe vasomotor symptoms [that's hot flashes and night sweats to you and me] will be available in US pharmacies by November 2013.

Ah, the good old FDA approving Paxil yet again for conditions that will no doubt increase the risk of suicide and/or homicide in this patient population.

Brisdelle is a low dose treatment of Paxil, trust me, there ain't no such thing, any dose of Paxil is too much.

Noven Therapeutics claim that "At the unique low dose of 7.5mg of paroxetine as a mesylate salt, Brisdelle was specifically developed for and studied in women who experience hot flashes and night sweats associated with menopause." They add, "Brisdelle contains a lower dose of paroxetine than is indicated for any other condition."

Indications mean nothing, we all know that. This approval basically means Brisdelle will be prescribed for a whole host of conditions. It's perfect for pediatrics out there to prescribe off-label. Only 7.5mg you see, much safer, they will have parents believe, than a single 10mg tablet [currently the lowest single tablet dose]

Hooray, finally a treatment for something that is perfectly natural. I'm not scoffing at this problem, obviously I'm just a guy and, thankfully, I'll never have to experience something like menopause.... wait a minute...

Let's go back in time, just so I can show you how pharmaceutical companies work.

The website was launched in 1999. Here's what they were saying about male menopause. [1]

The existence of Andropause is now recognized by the medical world - including the Canadian Andropause Society - and by Canadians alike.
In fact, a recent Angus Reid survey found that 70% of the general public share the belief that men experience a mid-life stage similar to women's menopause. Andropause (also called "male menopause") is a normal part of aging; although, for some men it is accompanied by a gradual and undesired decline in their sexuality, mood and overall energy. Sometimes it can even expose men to more serious health risks.
As with women, Andropause begins at a time when life often offers some of its greatest rewards.

There was even an "Andropause Quiz" for males to take. [2]

So, what is Andropause?

Well, here's what the website told us back in 1999: [3]

By the time men are between the ages of 40 and 55, they can experience a phenomenon similar to the female menopause, called Andropause. Unlike women, men do not have a clear-cut external signpost such as the cessation of menstruation to mark this transition.
Unlike menopause, which generally occurs in women during their mid-forties to mid-fifties, men's "transition" may be much more gradual and expand over many decades.
Although with age, a decline in testosterone levels will occur in virtually all men, there is no way of predicting who will experience Andropausal symptoms of sufficient severity to seek medical help.

Medical help?

The website made claims that "Andropause was first described in medical literature in the 1940's. So it's not really new. But, our ability to diagnose it properly is."

By March 2002 the website changed in appearance and, in addition to explaining what Andropause was, they now had a treatment for it.


Hey, and if you wanted to know more about this treatment there was even a special website for you to read about it,

Here's how looked in 2002. [Fig 1]

Both and carried the copyright symbol of NV Organon.

By 2006 that symbol was clickable. You'd never guess in a million years where it led to? [Fig 2] and

In fact, click on both links today and see where you are redirected to. Try them

Just cut and paste them into your browser. I won't hyperlink them because you need to do this for yourselves folks.

So, having covered the marketing of a drug to treat [ahem] andropause lets now turn our attention back to the 7.5mg Paxil pill, to be marketed as Brisdelle.

What you won't hear in the huge marketing campaign that will no doubt ensue are the side-effects to this drug.

This from the Brisdelle webpage:

Suicidal thoughts or actions:  
BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.

The website then goes on to tell us, "Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions."

But wait, Brisdelle isn't for depression or other serious mental illnesses is it?

They also warn you to call your healthcare provider right away if you have any of the following symptoms:

Serotonin Syndrome: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.
Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.
Manic Episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.
Restlessness: Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking BRISDELLE.

The restlessness they refer to is more commonly known as akathisia.

Akathisia has been studied as the mechanism by which SSRI-induced suicidality occurs and can be reduced by withdrawing or decreasing the dose of the causative agent.

In other words, if you take Brisdelle it may induce your own suicide.

Most strikingly the makers of Brisdelle have gone out on a limb. It's a refreshing move. They write the following:

Do not take BRISDELLE if you:
Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.

Nice job Noven Therapeutics!

I've screen captured the above line for prosperity [Fig 3]

No if's or but's about it. Paroxetine CAN harm your baby. [Click image to enlarge]

I'm unsure what clowns at the FDA granted license to this particular brand of Paxil. I can, however, be reasonably sure that more and more women are going to become addicted to this very powerful drug. But hey, don't worry about your addiction, that's easy enough to cure - just wrap a rope around your neck, pop a hose in a car, aim that gun at your head - Bang - addiction over.

Brisdelle [7.5mg of Paxil] is the new kid on the block.

I'm guessing that Noven Therapeutics pharmaceutical reps will have those cheque books ready to dine and dash those pediatric quacks and ask them to prescribe off-label. They may as well, every other pharmaceutical company who have manufactured SSRis have done it.

Bob Fiddaman

[1] [1999]
[2] Andropause Quiz [1999]
[3] What is Andropause? [1999]

Friday, June 28, 2013

Guest Post - Rip Van Winkle Awakes Surveys the Damage and Seeks Answers

Following on from Mark Carter's two previous guest posts.

Mark's time on SSRi medication should be a stark warning to those considering medication and those who dish it out.

Part I - Guest Post: Like A Lamb to the Slaughter

Part II - Guest Post: Life ‘at’ and Escape ‘from’ Paroxetine Island

Third and final installment...

Rip Van Winkle Awakes Surveys the Damage and Seeks Answers

Hi, my name is Mark and I am a recovering drug addict.

Even qualifying it by saying I was made a ‘drug addict by stealth’ by my friendly family doctor peddling poisons under a wrapper of fraud lies and deceit doesn't seem to lesson the spiritual heartbreak of this confession. The weight of which I find  difficult to bare at times.

As I write I am now 33 months drug free and yet I still feel like Rip Van Winkle waking up. Withdrawal is like an onion, each month you peel away another layer of drug damage and often you cry.

At 18 months and stabilising I then wrote letters of outcry to major media outlets. I then decided to confront those who did this to me and seek answers. I soon learned that seeking answers from the medical profession was a lost cause for none were to be  found or forthcoming. In fact quite the opposite.

First I presented to psychiatrist Dr SB  at the Te Raphiti Clinic Howick to make an official-in-person complaint regarding Paroxetine.  After having my humanity insulted for 10 years I was now about to have my intelligence insulted.

Seeking an explanation to my withdrawal horror Dr S.B. turned on me and tried to blame it on the Healtheries supplement I had taken. I thought that strange as he was the very one who had said it was O.K. to take. (Part II)

On explaining my sexual damage and trying to get an explanation for it he interrupted me with:

“Have you considered the fact you might have a sexual disease?”

What the … no doubt some kind of Te Raphiti joke!

This disgusting comment was extraordinarily offensive.  He did not ask me one single question regarding my lifestyle before throwing this insult at me. He clearly had no idea who he was talking to. Then when I tabled a research document by Dr David Healy, he refused to engage in it and immediately stood up and said, 

“Right I am discharging you back to your doctor now”

I was now convinced it was Dr SB by name but Dr BS by nature!

I then decided I would make a complaint regarding my plight to the Health and Disability Commissioner (HDC) and went to advise family doctor Dr W of this and to also voice  my concerns regarding Paroxetine and seek from him an explanation to my very serious sexual damage. When I told him he had chemically castrated me. He dismissively replied:

 “Well, what do you want me to do about it...look I’ve got other patients waiting to see have got psychological issues, I am referring you to the psychiatrist.”

It was now that I decided he did not deserve to be my Health Care Provider any longer so I immediately found a new one.

His parting comments:

“So do you think I shouldn’t prescribe SSRIs then?”, and “I would never have given you something I thought would have harmed you.” , were very revealing!

It is amazing what a letter of complaint to the HDC can do for 3 months later Dr W was in two newspapers singing a new song ‘Fewer Pills, better Life’ and ‘Pill-popping ends’. This turnaround was extraordinary. These stories are freely available to all.

‘Pill-popping ends’

‘Fewer Pills, Better Life’

I then reluctantly went to see the psychiatrist, for one reason and one reason only, and for the same reason I had gone there previously… try to get an explanation for my sexual damage, yet knowing full well they would just play games. I wasn't disappointed. Not happy with Dr B.S.‘s previous comments I requested to talk to someone else. I soon realised it was going to be another session of sick comedy when Dr Z. T. (Zero Truth) started off by claiming he had never heard of PSSD! I personally find this statement unbelievable especially since Eli Lilly have added PSSD to their prescribing information.

Here is Dr Z T explanation for my sexual damage;

I asked, “Is it going to improve because it seems to me like it’s been 2 years and it seems to be diminishing you know… I just want to know if it’s coming back or its  going to be permanent.”

Dr Z T from New York on secondment to the Te Raphiti Mental Health Clinic, Highland Park, Howick replied...

“Well I think the other factor that has to be considered here is age, now I  have the advantage or disadvantage of being older than you are and I know that ahhh  desires tend to diminish with age, so there’s that, and then there is also … circumstances I have to tell you that one thing I appreciate about New Zealand culture and on the other hand I have to say is quite different from the States is, there is very little sexual provocation around here women tend not to dress sexually whereas in the States if you are on the sidewalks of New York probably every 10th woman you would be looking at because she is dressed provocatively and have…. so the demure in which you are has a lot to do with it and one of the ways we know this is that ahhh because ahhh stories about Catholic priests and sexual abuse aside, when people dedicate themselves to the monastic life ahhh their  testosterone levels go down measured in this more accurate way as I’ve described um… so…. so  the prognosis here in part  depends  on whether or not you are reacting to age whether or not you are getting sexual stimulation apart from manual and um… and then  there’s the whole question of what role sex plays  for you psychologically ahhhh and um  to what degree  is that bound up in intimacy and that gets to be very complicated, there are some people who don’t have sex unless they are  feeling really close to another person, and there are other people for whom being close to another person is in fact somewhat of a turn off that’s why there are all these people who are married and have mistresses, (said with short subtle nervous giggle), so it can get very complicated and I can’t give you a prognosis!” 

For the audio click here.

It is high time the medical profession woke up and smelled what they are shoveling. This explanation is typical of the self-protecting, Vomitous, verbal diarrhea which exudes from  so called doctors. No doubt these people are actually intelligent yet they sure seem hell bent on doing all they can to prove otherwise! Is it any wonder patients are clueless about what is going on. And if doctors are not vomiting forth nonsense then their self-protecting silence is deafening.

Dr Z T was visibly physically repulsed at my suggestion that he try Paroxetine refusing to consider such an idea, finally giving this explanation as to why he would not try it:

“I would not take anything without googling it first” 

If only I had been so wise. It is obvious he wasted his money going to Medical School. He could have clearly put his skills and money to better use by investing in and working at a second hand car dealership. Dr Z.T.  refused to talk sensibly and engage in discussing researched facts for when I tabled truths regarding GSK and Paroxetine he stood up and said “well you are clearly not interested in our help”. Funny he didn't even suggest anything. “I’m leaving the room now” and he left refusing to talk to me, refusing to come back into the room, and leaving me in the room with two observing students! Let me just say that Dr Z T’s behaviour  was the most unprofessional, childish, immature, rude display I had ever witnessed from anyone in the workplace ever.

I then walked to the Managers office, made a complaint and then left. Interestingly I mentioned to the Manager that Dr BS had previously advised me that they do not prescribe Paroxetine at this clinic and yet the Manager said “that is not correct because we do”…oh boy! There are many who cannot get off paroxetine. Why is this? Well for a start doctors are totally misinformed of the potent nature of this poison. Secondly many, unlike myself, are unable to put aside 3 years of their life to spend hours daily lying on the floor in a foetal position with uncontrollable-sobbing-anxiety crying out to God to take them, while being hit with wave upon wave of traumatizing drug induced suicidal ideations.

In some ways Rip Van Winkle has awoken yet feels he has morphed into a Teletubby, same bloated stomach look, same distorted gait, same difficulty accessing vocab from  brain and (no offense to Lala, Po, Dipsy, and Tinky Winky)  same sexual (in)ability.

I say it is a miracle I am still alive after surviving this hell as such I speak for the dead in order to protect the living. I am gravely concerned that adverse reactions are being greatly underestimated by the public, the medical profession and the regulatory authorities. As such I believe a public health problem of epidemic proportions is unfolding in this nation or for that matter worldwide.To those working as pimps for pharma I would like to say...

“The prescribing of Paroxetine/Aropax/Seroxat/Paxil/Loxamine/any other name this evil poison is hiding behind and its evil cousins (including Venlafaxine/Effexor) must be stopped!”

It is time for Medical Professionals to wise up, man up, own up, stand up and speak up!

Thank you for reading my story and thank you to Bob Fiddaman for being a voice for the voiceless.


Mark Carter( Poisoned, ruined and sexually destroyed by an SNRI and SSRI)

BSc (Maths), BAppSc (Psych), Dip.(Psych), Dip.(Health and Human Behaviour), Dip.(Primary Tchg), Dip.(Bus), Dip.(Tesol), Cert.(Tesol), Cert.(Applied Theology).

Pending: Dip.(Applied Mental Health), Unfinished: Actuarial degree, BCom, and BTheol.


If you would like to write a guest post for this blog then please email by using the contact tab at the top of this blog.

Bob Fiddaman

Wednesday, June 26, 2013

Sudden Surge of Hits on Fiddaman Blog

Weird stuff.

I average between 800 - 1500 hits per day on this blog... until this past week when hits have just exploded.

19th June - 6,018 visitors
20th June - 3,089 visitors
21st June - 609 visitors
22nd June - 822 visitors
23rd June - 3,809 visitors
24th June - 4,845 visitors
25th June - 6,576 visitors [Fig 1]

Fig 1

So bizarre.

Bob Fiddaman

Tuesday, June 25, 2013

Pharmaceutical Intensive Care

SSRi use during pregnancy

What is Intensive Care?

Intensive care units (ICU), also called critical care or intensive therapy departments, are sections within a hospital that look after patients whose conditions are life-threatening and need constant, close monitoring and support from equipment and medication to keep normal body functions going. [1]

The British flagship programme Panorama is stirring the pot again, this time, it seems, it's siding with those who warn against the use of SSRi type medications in pregnant mothers.

Good for them.

I've highlighted SSRi birth defects on this blog many times, particularly paroxetine birth defects. It now seems a given that paroxetine, commonly known as Seroxat in the UK, Paxil in the states and Aropax in the Southern Hemisphere, can cause birth defects. But what about the other group of SSRis?

We, as consumers, constantly hear that the jury is out on their safety during pregancy and that doctors have to weigh up the risk/benefit ratio before prescribing.

This is classic pharmaceutical deflection and, dare I say it, medicine regulator deflection too.

Who is ultimately responsible here, the pharmaceutical company that make the product that can harm unborn children, the limp-wristed regulators who are supposed to regulate the drugs consumers take or the doctors who prescribe the drugs?

Personally, I believe it's the manufacturer who should be held accountable, there are many who take a different viewpoint, all valid views I might add.

Let's say you have fallen pregnant and you are feeling down. You go to your doctor and he, after apparently weighing up the risk/benefit offers you an antidepressant from the SSRi family. He tells you that untreated depression may harm your child and using an SSRi will therefore work to protect the child.

It's ridiculous when you think about that kind of statement. Its a statement that ignores the fact that 'depression' (sadness arising from negative life events or circumstances) can be treated by addressing the social factors causing it rather than by prescribing drugs that cause birth defects.

Let's say our subject is depressed because her employers have told her that there are going to be job cuts. She, like most, would worry. Because she is pregnant she'd probably worry more. How can I now afford to look after my child?

Pharmaceutical companies, regulators and doctors will have you believe that our subject is passing on her concerns to her unborn child. It's the selling point and one that is cruel and heartless. I don't think there is any doubt that having a mother who is scared, stressed, sad etc has a negative impact on a baby but surely that suggests doctors should be providing support to remove or cope with the stressors not prescribing drugs that they do not deny carry a risk. There are no risks associated with joining a new mothers coffee group, getting budget advice, seeking the support of friends, family or social service organisations and if the root causes of the distress are dealt with, huge benefits for both mother and baby. This approach surely has a better risk/benefit profile than prescribing antidepressants but of course doesn't come with the rewards to doctors from big pharma that prescribing does. Nor is it able to be provided in a 15 minute appointment which maximises profit for the doctor's business.

BBC Panorama spoke to eight mothers whose babies came into this world with serious heart defects. All eight mothers were taking SSRi medication during the course of their pregnancy. We are expected to believe that this is just a coincidence.

Babies are born with defects all the time and this really has nothing to do with what the mothers ingest... unless of course the mothers have been smoking, drinking alcohol or taking illegal substances during their term.

Yup, blame everything but the drug that is prescribed widely, right?

So, let's assume that our subject weighs up the risk/benefits herself and decides that taking an SSRi would increase the risk to her unborn child. But our subject is a smoker and want to quit... she has tried many times but just can't kick the habit.

Her doctor, once again, has a drug that can help her. Once again he has to weigh up the risk against the benefits. Chantix [also known as Champix] can, according to its manufacturer Pfizer, help anyone quit smoking. Zyban [also known as Wellbutrin] can, according to its manufacturers, GlaxoSmithKline, also help you quit smoking.

Your unborn child is, women are told, more at risk if you continue to smoke. This maybe true but both Chantix and Zyban, the latter being an antidepressant rebadged by GlaxoSmithKline, can also cause serious abnormalities in babies.

So, where do the regulators come in?

The UK medicines regulator, the MHRA, made recommendations back in early 2000 that SSRis should not be prescribed to children or teenagers. They did this because they had reviewed the evidence and found that there was no benefit in this population taking SSRis. In fact the evidence showed that there was an increased risk of suicidal thinking while this age group was taking an SSRi.

Now, I'm not suggesting that unborn children can have suicidal thoughts but if a drug can induce such chemical changes in the living then are we expected to believe that it will make no alterations to a child growing inside its mother?

The MHRA can and will tell us that they have played their part. They have issued the warnings to the prescribing physicians.


"Hey kids, don't touch that fence, it has electricity running through it", the man on top of the grassy bank tells the children.

"Don't believe you", Simon tells the man.

Simon touches the fence. Many volts of electricity are passed through his body. Simon dies as a result of his injuries.

8 days later...

"Hey kids, don't touch that fence, it has electricity running through it", the same man on top of the grassy bank tells the children.

"Don't believe you", Julie tells the man.

Julie touches the fence. Many volts of electricity are passed through her body. Julie dies as a result of her injuries.

The man stands from his sitting position. He's satisfied and has no conscience, he did, after all, warn of the dangers.

Would a humanistic more active approach to protecting the lives of these children have been called for here?

Should the man have raised alarm, been more vocal, called the relevant authorities or maybe erected warning signs in clear bold text, "THIS FENCE IS ELECTRIC". Might warning parents that the fence was dangerous and urging them to monitor their children closely when in proximity to it have been warranted?

The man had been sitting on the grassy bank for many months. In total he had witnessed 5 children touch the fence. Only two of those 5 had died as a result of their injuries. The other three suffered burns but lived as a result.

Because of this the man decided that more people who touched the fence survived than those who died and the fence was therefore not a risk to children.

Bizarre way of thinking, right?

But this is the exact logic that regulators are using when it comes to mothers taking antidepressants during pregnancy. Moreover, they are passing the buck and allowing doctors to make the call.

Let's just take a look at a recent birth defect trial in the United States. The decision of which found GlaxoSmithKline guilty.

When the verdict was announced I contacted the MHRA and asked if they were going to change the labelling on Seroxat now that evidence had emerged that it was a clear teratogen [2]. They told me they were not. I wrote a whole chapter about this in my book where I produce the email correspondence between myself and MHRA CEO, Kent Woods [3]

Here's an extract from court documents [Kilker Vs GlaxoSmithKline]

September 15, 2009
13 Courtroom 253, City Hall
Philadelphia, Pennsylvania

Sean Tracey of the Tracey Law Firm [Attorney for Kilker]
Glaxo were represented, as usual, by King & Spalding

MR. TRACEY: May it please the Court, good morning.
JURORS: Good morning.
MR. TRACEY: I am going to reintroduce myself. My name is Sean Tracey. I represent Michelle David and Lyam Kilker. Before I begin, I want to reintroduce to you Jamie Sheller here, and there are a couple young lawyers up front here. Scott Love and Adam Peavy you are going to see wandering around and probably hearing from during this trial. Who you haven't met are my clients. This is Michelle David. Michelle, will you stand up. This is Michelle David. Over here with Michelle's mother is Lyam Kilker. Lyam is here with his grandmother. Lyam is going to stay a few minutes, then I think his grandmother is going to take him out of the courtroom.

Next we see Tracey explain to the jury the injuries caused to Lyam Kilker.

MR. TRACEY: This is the time for me to talk to you about what I believe the facts are going to be, what I think the evidence that comes in during this trial is going to be through the witness stand starting this afternoon, and through the documents that I have obtained as a result of this lawsuit. And so I want to start that by, this is the name of the case, as you have heard, Kilker versus GlaxoSmithKline. And Lyam Kilker, this is going to be undisputed, Lyam Kilker was born October 24, 2005. And shortly after he was born, Michelle found out he had been born with a series of congenital heart defects. During the time Michelle was pregnant, before she was pregnant, she was taking Paxil. She was on Paxil for her first trimester. Now, Lyam, after he was born, was at the hospital and he was diagnosed and his heart defects, there really are three. One is called the ventricular septal defect. One is called an atrial septal defect. Those are holes on the inside of the heart in the walls that separate the four chambers of the heart. The other heart defect he had is something called an interrupted aortic arch. The aorta, where it is supposed to curve, doesn't fully develop. And so what he has is three different, distinct heart defects, each of them related to the failure of his heart to fully develop.

Tracey then goes on to explain to the jurors about the FDA pregnancy categories.

MR. TRACEY: The first one is pregnancy Category A. Are there adequate and well-controlled studies? Are there human studies that demonstrate there is no risk to the fetus? If it is Category A, you can take this drug with impunity and you don't have to worry about children, you don't have to worry about if she gets pregnant. You will learn during this trial that, I think, over 50 percent of pregnancies in the United States are unplanned. Women aren't planning on getting pregnant. That's why these categories can be so important. You don't just consider these categories when you have a woman who is planning a pregnancy. It is any woman of childbearing years who may become pregnant. The evidence in this case is going to be that GlaxoSmithKline knew that over 50 percent of the women in the United States became pregnant without trying to, they were unplanned pregnancies. They knew this back in the 1990s. So Category A, no problems.
Category B, we have done animal studies, doesn't look like there is any problems. Animal studies have failed to demonstrate a risk to the fetus, but we don't have any human studies.
Category C is, we have done animal studies, we have done animal studies, and the animal studies have shown an adverse effect on the fetus, but we don't have any human studies at all.
Category D is, there is positive evidence, there is positive evidence of human fetal risk based on a number of different things, either adverse reaction data from investigations they do or adverse marketing data from women and doctors reporting problems with the drug or from studies. And in that case in a Category D drug you do not prescribe that drug to women of childbearing age with one exception. If the doctor decides that the benefit to the patient is worth the risk to the fetus, then the drug can be prescribed. Doctor Healy, who is a psychiatrist and neuropyschopharmacologist who is going to testify this afternoon, will explain that there may be times when the disease is so serious that it may be worth the risk to the doctor and the patient if there is a life-threatening illness. If somebody is capable of harming themselves or others, they may make the decision to prescribe the drug if, there is no alternatives.
Category X is, we don't care what the benefits are. You do not give this drug to a woman unless she has a pregnancy test that shows she is not pregnant.

Tracey adds:

MR. TRACEY: In 2004 when Michelle David was prescribed this drug, it was a pregnancy Category C, and GlaxoSmithKline says their animal studies have revealed no evidence of teratogenic effects.
Tracey then explains to the jury the process of human development.

MR. TRACEY: In human development when women get pregnant, what you are going to learn and understand is that the most vulnerable time to the human fetus is from weeks 3 to weeks. That is when the fetus is dividing and growing and is the most susceptible to something called a teratogen to a drug that can cause a birth defect. During weeks 3 through 8 the body is rapidly, rapidly expanding, rapidly developing. Cells are being signalled to go to where they are supposed to go. The heart is developing by week 8. By week 8 the heart, from a cellular perspective, is almost completely developed, and there is nothing you can do after that to prevent the heart, to prevent a heart defect if it has already occurred. The importance of this is that when women don't know or aren't planning on becoming pregnant, many times, most of the time, by the time the woman finds out she is pregnant, the damage has been done. This is when in this time frame, weeks 3 to 8, almost every congenital abnormality -- that is a fancy word for a birth defect -- almost every congenital abnormality happens during this time frame.
Tracey goes on to explain to the jury what a teratogen is. In a nutshell, a teratogen is any agent or factor that induces or increases the incidence of abnormal prenatal development.

Enter Dr Sloot

MR. TRACEY:  So during the course of this trial you will hear about teratogens and teratogenicity and you will find out about whether Paxil is a teratogen. And one of the ways you are going to learn about this is through a study, an animal study, an animal study done by a doctor named Sloot. Doctor Sloot is a European doctor who works for another pharmaceutical company called Shearing Plough. Shearing Plough is a pretty big company. You may have heard of it. In May of this year, 2009, a study was published by Doctor Sloot. The study said this. What Doctor Sloot did is, he took Paxil and all the other reuptake inhibitors and he exposed rat fetuses to these 12 different drugs, including Paxil. And what Shearing Plough was trying to figure out, what they were trying to do was figure out whether one of the drugs that they were going to put on the market to compete with GSK's drug was capable of causing birth defects. And so they took the drug they were going to take to market, and before they took it to market, they did this test. And they compared it to all the other SSRIs. Because, as you will learn, GSK never did this test. What Doctor Sloot discovered in May of this year is that out of all the teratogen --out of all the SSRIs, the 12, only one was a clear teratogen, Paxil. He discovered that Paxil in May of this year was actually more powerful a teratogen than cocaine. It would be safer, according to Doctor Sloot's study, to take cocaine than it would be to take Paxil while you were pregnant.

The Evidence

MR. TRACEY: I told you earlier that the way you learn about this case is through evidence, through witnesses that take the stand, through documents. And you are going to see documents in this case that have never seen the light of day before. You will see internal GlaxoSmithKline documents that the FDA hasn't seen, that the United States Congress hasn't seen, and that no jury has ever laid their eyes on before. For the first time in this trial you will see these documents. They have been under seal for over three years. And that's the way, one of the ways, you are going to learn about what GSK knew and when they knew it.

Tracey then explains to the jury how Glaxo had purchased the compound [paroxetine] from a Danish company called Ferrosan. He continues...

MR. TRACEY: Ferrosan had done the preliminary animal studies to look at teratogenicity. And they were done, I believe, in 1979 and 1980. And one of the studies was called Study 295. This is a study where they give Paxil, paroxetine, to pregnant female rats. And what the evidence showed in Study 295 is that the rats that got no Paxil, 88 percent of them were alive or 12 percent were dead by the fourth day after they were born. The ones that were given 5 milligrams of Paxil, 65 percent were dead by day 4. The ones that were dosed with 15 milligrams of Paxil, 92 percent were dead by day 4. And in the ones that were given 50 milligrams of Paxil, 100 percent were dead by the fourth day after they were born.

Ferrosan's Dr Baldwin

MR. TRACEY: At the time a doctor by the name of Baldwin, who works for them, Doctor Baldwin looked at the studies. He looked at Study 295, another study called 296, another study called 297. And 12 years before they started selling this drug to women in the world, Doctor Baldwin had some comments about these studies. What he told them internally -- this is a document that nobody has ever seen before. What he told them internally was: There remains the possibility this compound could be teratogenic at higher dose levels. As he saw, as you just did, that the more Paxil you got, the more rats died. And these were not heavy doses of Paxil. What he was concerned about was whether or not Ferrosan or anybody else was going to conduct or intended to conduct peri and postnatal studies to answer the question to why the rats died. He wanted to know that. In 1980 he sent a memo to the powers-to-be at Beecham. He said this needs to be done. The rats died. He talked about embryolethality. That means the fetuses die.

FDA Revolving Door

MR. TRACEY: Because I saw the animal studies that you just saw and the evidence that you will see about the animal studies and the rat pups dying, and I wondered how they could market the drug and say in the beginning that there were no problems with the drug. What I found out is that the FDA investigator that signed off and said you can sell your drug to the public is a guy named Gary Evanuic (sp.?). And Gary Evanuic, who signed off on Paxil being a Category B drug, now works for GSK. He works for GSK in the very department that sells Paxil.


MR. TRACEY: And as we are rocking along, in 1994 we are selling in the United States, we are selling in Europe. Business is brisk. Business is going well. And they want to move into other countries. They want to sell their drug in other countries. And they have a company called SmithKline or Smith Beecham Japan. It is one of their companies that is in Japan that sells their drug, one of their 70, I think, companies. And the Japanese, they suspected, were not going to accept their dead rat pup studies because they suspected the Japanese, because of the historical things that have gone on in Japan with birth defects related to Hiroshima, Nagasaki, and another environmental disaster there called Minamata, the Japanese had a heightened sense of concern. GSK believed that's what would be going on. And so GSK began discussions internally. Internally among themselves they said: What are we going to do, what are we going to do if Japan makes us do the studies to find out why the rat pups died? What are we going to do? Because what the documents, the internal documents that the FDA has never seen, that nobody else has ever seen, is, their conclusions were, if the Japanese make us do the studies to prove why the rat pups died, we might lose the United States market. So GSK was looking at science and research, not from the aspect of whether or not their drug was going to induce birth defects in children, but the evidence will be their only concern was commercial. Their only concern was whether they would lose the American market. The quote from them is: GSK concludes this is the study, the type of study we wish to avoid. We simply don't want to know the answer to these questions. They say: If the Japanese do request a study, if they do it, there is a potential problem, they may insist on us doing a study to their preferred design. And so what they did in March of 1994, they got a woman or man, I'm not sure which, I haven't been able to find out, named Gwyn Morgan. They got Gwyn Morgan involved. They put Gwyn Morgan in charge of reviewing the study designs that they would give to the Japanese. And Gwyn Morgan was to ensure for the company that any potential negative outcome from the studies is minimized. They designed the study to fail. They wanted the study to fail.

GSK Sales Reps

MR. TRACEY: GlaxoSmithKline has 110,000 employees. I think 40,000 of them are salespeople. What these people do, you will learn, is, they go to doctors' offices. And they take literature and they take cookies and they take lunch and they take pens and they take samples of Paxil. And they tell the doctors why they should prescribe their drug. These are bright, sophisticated, educated salespeople. They are the backbone of this company. And what they were telling doctors in the mid-1990s is that no drug is safer than ours for pregnant women.

Japan Revisited

MR. TRACEY: So we are rocking along. Remember that Japanese study I told you about, Doctor Patrick Wier? Well, they designed a study -- they avoided the studies they wanted to avoid and they designed a study that they thought would satisfy the Japanese, and they were right. But even in the study that was designed to fail, something cropped up, something that was potentially a problem for them. In this study done by GSK, which, quite frankly, by the way, was not a study designed to find out why the rat pups died, it was not a study designed to find out the answer to the questions Doctor Baldwin had in 1980, but some of rat pups did die, and they autopsied one of the rats. And in one of the rats they autopsied, they found that the rat that was found dead had edema, swelling around the heart, and it had a ventricular septal defect. The very same defect Lyam Kilker has. The very same defect that they had started receiving reports of in 1997. But they blew this off. They minimized it. In their conclusions they didn't even mention it. It is buried in the back of the study in an appendix.

Cannot Stop Taking Paxil

MR. TRACEY: Now, this case is primarily, primarily, about birth defects, primarily about what happened to Lyam Kilker and whether they knew about what would happen to him. But in the course of selling Paxil for the past 15 years other issues have come up. One of them is this. In the mid-1990s some studies came out, some literature came out, showing that Paxil had a significant problem with withdrawal. What that means is this. They were finding that women that took the drug and then want to the stop couldn't get off of it. So they would get sick. They would try to stop and they would get sick. And so they would be forced to keep taking the drug so they wouldn't be sick.

Glaxo Burying Data

MR. TRACEY: In the mid-1990s there had been some studies done, not by GSK but by others, and talking about withdrawal. This, you are going to learn from the evidence, caused them some concern. They were concerned about losing their market, losing their market to Prozac. And what they decided to do was, do their own study. And one of the documents you are going to see is this document, a document from a woman named Bonnie Rossello. Bonnie Rossello is the vice-president of GSK's marketing, Paxil marketing. And what Bonnie said in 1997 was: In response to this, let's do our own studies. Then we will own the data. If the results come back negative, we can bury it all. We can bury the evidence that our drug is a problem. In 1997 that's what she said.

The full opening statement can be downloaded HERE

After hearing evidence from both sides Jurors deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil's risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker.

With the latest news coming from BBC's Panorama about other SSRi's causing birth defects it pays to do your homework on these types of drugs before taking them. The pharmaceutical companies won't be clear and concise about the risks because it would only serve to harm their profits. The regulators won't be clear and concise because they refuse to see the link, even when sent evidence from the above trial. Doctors will continue to prescribe because they have been told that untreated depression can harm the unborn - I have yet to see any clear evidence on this that has not been funded the the pharmaceutical industry.

Forget the doctor weighing up the risk/benefit - Weigh up the odds yourself. Don't be fooled by the stethoscope and BNF in your doctor's office. Look for the product placements, note pads, coffee cups, calanders - I'll guarantee they have the name of a drug on them. That's called good pharmaceutical repping.

Panorama will no doubt be accused of scaremongering. To me, at least, the biggest scaremongers are those that tow the line that untreated depression in pregnant mothers can harm the foetus and then prescribe an SSRi.

Whilst there may be evidence that depressed mothers should treat there depression there is no evidence that SSRi treatment can help protect the baby.

If you stop and think about clinical trials for SSRis it leaves you with a burning question.

Clinical trials for SSRis all have a protocol to follow. All stipulate that there can be no subjects allowed onto the clinical trials that are pregnant.

Women, when faced with the decision of taking antidepressants, should remember this. They should also ask their prescribing physician to provide them with evidence that SSRi treatment can prevent their foetus from developing depression.

There is no evidence. If evidence were needed pharmaceutical companies who carry out trials would include pregnant women in these very same trials. They don't because there is a risk.

SSRi birth defects include, but are not limited to:

Abdominal Birth Defects / Omphalocele
Anal atresia (complete or partial closure of the anus)
Autism Spectrum Disorders
Cardiac (heart) defects
Cleft lip and cleft palate
Clubfoot (one or both feet turn downward and inward)
Craniosynostosis (skull defect)
Limb Defects
Neural-tube defects (brain and spinal cord, spina bifida)
PPHN (Persistent Pulmonary Hypertension of the Newborn)

Even if you have taken antidepressants during pregnancy and your child is born defect-free you still have many hurdles to jump.

Breast feeding an infant whilst taking an SSRi carries risks too. Mothers could unknowingly be feeding the very same drug to their infants that the regulators have warned against giving to children and teenagers.

I've yet to see any Sir David Attenborough documentary that has showed me an animal eating toxic plants before allowing her young to suckle.

And we, as humans, claim to have the highest intelligence.

The Panorama story can be found HERE.

The following video contains images that some viewers may find disturbing.

Bob Fiddaman

[1] The Intensive Care Society
[2] "Teratotogen" - Medical Dictionary
[3] The Evidence, However, is Clear - The Seroxat Scandal

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