**EXCLUSIVE VIDEO: LAWYERS DISCUSS THE RECENT GLAXO V KILKER CASE

This is pretty riveting stuff - I only wish they could do this on national TV with an audience and I do hope that one day GlaxoSmithKline actually go the distance with an appeal and lose... instead of settling the case.

There are an awful amount of Internal documents from the Kilker case that have been sealed, they will remain sealed if Glaxo settle the appeal - which, they probably will.

Personally, I think this is appalling behaviour by GlaxoSmithKline. Lyam Kilker was born with heart defects [3 different heart defects as it happens] - A jury found GlaxoSmithKline's Paxil [Seroxat] to be the causation of his heart defects. Glaxo appeal the decision - yet settle other 'birth defect cases'. Meantime, the family of Lyam Kilker are plunged into another long wait which, I think, will result in an out of court settlement some time down the line.

It's one thing to manufacture a drug that harms a child, but to then punish the family and child because they won at trial is pretty despicable even by GlaxoSmithKline's standards.

Everyone, even GSK, have a right to appeal but we all know what the outcome of this tragic case is going to be - Glaxo will settle, they cannot afford for the sealed documents to be made public property.

My heart goes out to Lyam Kilker and his loving family. All his mother is guilty of is taken Paxil for what can only be deemed as mild depression. She never knew the damage it could cause her fetus because GlaxoSmithKline never told her... more importantly, they never told her doctor.

The case of Lyam Kilker was a 'test' case - basically Glaxo dipping their toes in the water to see how hot it is. It appears their toes were scolded.

Expect settlements with the other 630 birth defect cases they dispute.

Did they know of the dangers of pregnant women taking Paxil?

Watch the video.

The first 30 seconds is audio only, while the team prepare to go on air. The video is uncut and exclusive to Seroxat Sufferers blog.




Special thanks to the production team at Law Journal TV for passing this on to me and granting me permission to use on Seroxat Sufferers.

After watching the video, take a look at the files that have been made public from the recent Kilker v GSK trial, including a testimony from Ex-GSK executive Jane Nieman which was pretty damning for GlaxoSmithKline.

**Footnote

The MHRA have access to the documents. They refuse to act on them. A strong message of support for GlaxoSmithKline it would appear.

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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More Paxil Birth Defect Woes for Glaxo

It would appear that GlaxoSmithKline have some sort of sick fetish for courtrooms or battling against consumers who complain about their antidepressant, Paxil [Known as Seroxat in Europe and Aropax in the southern hemisphere]

It's just been announced that Canada has been given the green light to attempt to seek justice for its first national class action lawsuit against GlaxoSmithKline, the manufacturer of Paxil, which is alleged to have caused birth defects in children born to women who took it during pregnancy.

Representative plaintiff, Faith Gibson, took Paxil during her pregnancy throughout 2004. On September [same year] her daughter, Meah Bartram, was born with a hole in the heart.

The class action, given the thumbs up by The Supreme Court of British Columbia, will see lawyers argue that GlaxoSmithKline knew or ought to have known of the risks and failed to provide adequate and timely warning to doctors and the public.

The Supreme Court green light can be viewed, in full below:

**Exclusive - JANE NIEMAN VIDEO TESTIMONY GSK V KILKER

Back in 2009 a jury found by a majority of 10 -2 that Paxil was the causation of Lyam Kilker being born with serious heart defects.

During the trial much evidence was heard, what swung it for the jury was a deposition given by Jane Nieman who, in 2005, was employed by GlaxoSmithKline, the makers of Paxil.

Nieman, under oath, gave a video deposition.

For the first time, that video has now been made public and the edited version of the transcript is also available.

There are three reasons why I feel this should be made public.

1. It highlights how GlaxoSmithKline knew Paxil could cause serious heart defects...yet chose to do nothing about it

2. It clearly shows how GlaxoSmithKline's position of helping consumers affected by their product is one of a total lack of care, duty and responsibility.

3. GlaxoSmithKline, more often than not, settle out of court. On the two occasions where they have defended Paxil, they have lost. The Kilker case was such an occasion.

This lack of care continues today. GlaxoSmithKline refuse to help consumers struggling with their prescription drugs, they recommend that you "talk with your doctor".

The video and transcript from the Kilker trial shows how this wanton neglect is part of the money-making machine that is GlaxoSmithKline.

Briefly, the Kilker family had alleged that their son, Lyam, was born with a heart defect. During the pregnancy Lyam's mother had been taking Paxil.

Items of disclosure showed that another patient had 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.

The video deposition sees lawyers probe Nieman for answers. What she revealed was damning for GlaxoSmithKline. It's also interesting to note that Nieman digs herself an even bigger hole when she suggests to lawyers that the initial report that concluded that the patient's termination was "almost certain" [related to Paxil] may have been a clerical error. Under oath she said;

"There's always the possibility someone made the mistake and checked the box wrong."

On hearing this, lawyers, rightly so, asked the following:

Q. Let's talk about the probability. Is the prob -- the probability is that somebody at GSK filled that in on the computer. Would you agree with that?

A. Somebody at GSK filled that in on the computer, definitely.

Q. Nobody from Pro -- from Eli Lilly or Schering-Plough came in there and secretly filled this in, right?

A. No. Right. Definitely that did not happen.

Q. And the doctor didn't break into the database, or the patient, and fill that in or write down or check off "almost certain" twice; did they?

A. I don't understand -- no.

Q. Nobody broke into GSK's database

A. No, no.

I'm sharing this video because I believe the public have a right to see how GlaxoSmithKline knew a very long time ago about the dangers of pregnant women taking Paxil [known as Seroxat in UK]

Here, for the first time, is Nieman's video deposition. It's especially for GlaxoSmithKline's UK lawyers, Addleshaw Goddard and comes with the message, "You can't keep a good man down"





Here's the transcript:

The full court transcripts from the Kilker trial can be viewed on my sister blog, GlaxoSmithKline Internal Files.


Fid 


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AUSTRALIAN ORDERS HERE

Paxil Birth Defects... (They Knew)

Today I am going to revisit a Paxil birth defect case from 2009.

What makes this case unique is that court documents were made available, giving us all an insight into how trial lawyers operate and how unsealed evidence proved to be the downfall of British pharmaceutical giant, GlaxoSmithKline.

I'm going to focus on the opening statements that were read to the jury by the plaintiffs attorney. The purpose of an opening statement is for an attorney to tell a jury what he/she expects the evidence to show.

The case, LYAM KILKER, a Minor, by MICHELLE M. DAVID, as Next Friend and Individually VS. SMITHKLINE BEECHAM CORPORATION d/b/a  GLAXOSMITHKLINE, astounded many as little by little the truth came to the surface regarding Paxil's propensity to cause birth defects.

Lyam Kilker was born with heart defects. His mother, Michelle David, had taken Paxil during her pregnancy.


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

To set the scene, in other words, to make this more humane than (as it turned out through the verdict) inhumane. Sean Tracey introduces both Lyam and his mom to members of the jury.

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.

Japan

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.

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

Bob Fiddaman

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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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Glaxo Executive’s Memo Suggested Burying Drug Studies

Just in from Bloomberg

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.


By Jef Feeley and Margaret Cronin Fisk

Source: Bloomberg

An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced in trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of an injured child.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors. “They do not want to scare anybody. It’s a very competitive marketplace. It’s a multibillion-dollar industry.”

‘Rare Thing’

Glaxo executives contend that the boy’s heart defect wasn’t caused by Paxil, Chilton Varner, one of the company’s lawyers, told jurors today in her opening statement. In court filings, the company has said it appropriately tested and marketed the antidepressant drug.

“When Lyam Kilker was born in 2005, GSK had not received notice” of his specific type of heart defect in connection with Paxil use, Varner said. “The numbers will tell you the defect is a rare thing.”

The Paxil label at that time reported about animal studies, “including the rate deaths,” she said.

Glaxo didn’t target pregnant women and its sales force didn’t use strong-arm tactics to push prescriptions, Varner said. “Whatever the marketing was, it played no role in Ms. David’s doctors’ decision to prescribe Paxil or Ms. David’s decision” to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they’d be seeing documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil and officials found “an alarmingly high number” of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and “the alarming language” was deleted from it, the lawyer said.

In 2001, the company received a letter from a woman who used Paxil during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman’s case, Glaxo officials concluded in an internal report that it was “almost certain” the fetus’s birth defects were caused by his mother’s Paxil use, the family’s lawyer added. Still, the company didn’t turn over its analysis to the FDA or beef up the drug’s warning label, Tracey said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association’s Philadelphia 76ers, told jurors that Glaxo hid Paxil’s problems to protect its profits.

Paxil is “the No. 1 asset to this day this company has ever owned,” the attorney said.

‘Quite Different’

Varner said she’d present evidence on animal tests tied to Paxil that will be “quite different” from that presented by Kilker’s family.

“The animal testing did not suggest Paxil caused birth defects,” she said. She noted that the FDA considered those tests when it approved the drug for use by U.S. consumers in 1992.

Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

Wyoming Jury Award

In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled while on appeal, according to Kevin Colgan, a Glaxo spokesman.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Colgan said earlier this month.

Glaxo American depositary receipts, each representing two ordinary shares, fell 54 cents, or 1.4 percent, to $38.90 at 2:03 p.m. in New York Stock Exchange composite trading.


Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Paxhell for Birth Defect Child, Manie Edgington

With one case out of a possible 632 going against them, GlaxoSmithKline are oblivious to the many children whose daily routines have been blighted by their blockbuster selling drug, Paxil [Seroxat in UK].

With a jury finding the world's second biggest pharmaceutical company guilty of negligently failing to warn about the dangers of Paxil in pregnancy and being found guilty of manufacturing a drug that was a “factual cause” in Lyam Kilker being born with heart defects, one would think an apology of some sort was in order. Instead, we hear that GlaxoSmithKline are to appeal against the recent decision. No surprise there, Glaxo's highly paid law team wouldn't be doing their job if they just threw in the towel at this stage.

During the first week or so of the Kilker v GSK trial, Glaxo lawyers called for a mistrial on 5 separate occasions, this figure may be higher as I have only seen the court documents from the 15th Sept to 23rd Sept. They may have made further motions for a mistrial after the 23rd - hopefully more documents will be coming soon.

The Kilker family were awarded $2.5 million, it seems a lot, but when you consider the medical expenses they have already endured, it's a very small pittance.

The jury's decision has made way for a further 632 cases brought against GlaxoSmithKline, one such case being that of 5 year old Manie Edgington from Iowa.

Manie was born with Transposition of the Great Arteries [TGA]. His mother, Julie, briefly explains about TGA on her blog, Big Pharma Victim. She writes:

"TGA means the aorta and pulmonary arteries in the heart are switched. When a child is born with TGA there is very little oxygen in the blood. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen. The pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs."

During the past few days, Julie, her husband and 5 children have made a 600 mile round trip to Wisconsin to see a heart specialist. 5 year old Manie has been getting leg and arm cramps plus a whole host of other complaints. The Wisconsin specialist now wants Manie to have a cardiac cath to try and determine why he keeps getting leg and arm cramps. "A cath, Julie writes, is a procedure whereby a small camera is placed inside the artery which runs along the inside of Manie's leg all the up to his heart where they can look at everything."

Not very pleasant huh?

Julie also writes, "Manie also has a leaky heart valve caused by open heart surgery do to the TGA Paxil caused." She continues, "Every time they try and try to see the pulmonary vessels but they can never view them. This is because when you have had your arteries switched, like Manie has, those vessels are just hidden. Well it seem that these very vessels just may be what is causing Manies problems. This was found out in Wisconsin due to the fact the Dr. could hear some problems in that area when listening to Manie's heart. Ahhh haaa makes sense huh."

A simple MRI or CAT scan would be useful for the 5 year old but this avenue has been closed to Manie due to Manie having coils in his chest which could interfere with the expensive machinery. Julie writes, "If Manie had never had the collateral's which required coils then the Dr. may be able to do a MRI or CAT scan to see the vessels. The coils Manie has in his chest will cause interference with the machines which means a pretty messed up picture of a whole lot of nothing. So until we have a cardiac cath done we really just don't know whats going on."

Manie is one of approx 632 children who suffer on a daily basis. Manie, like the other 632 children, all share one common factor. They were all exposed to Paxil during varying stages of their foetal growth.

GlaxoSmithKline deny that Paxil has anything to do with these children being born with heart defects. They denied that Paxil had anything to do with Lyam Kilker being born with heart defects, despite being found guilty, they still deny.

I don't know about you but I am left scratching my head. If you or I were found guilty of a crime we would have every right to appeal, but when a punishment had been handed down to us for that crime any appeal would surely come from behind the bars of a prison if we were ever given a custodial sentence. We certainly wouldn't be given the opportunity to defend ourselves in the media, as Glaxo seem to be doing.

They had their chance to defend themselves in court, their law team could not defend them - they lost.

The only losers in this are these children. It's really not as simple as 'Child A' was born with a defect. 'Child A' will have to go through life visiting specialists, having operations and being restricted in what they can or can't do. Their parents will wake every morning, they won't be heading for the coffee, first stop will be their child's bedroom just to see if he/she made it through the night.

Manie Edgington is fighting against something that he should not be fighting against, he fights for survival. A 600 mile round trip from Iowa to Wisconsin should not be in Manie's itinerary. He should be playing with his brothers, sisters and friends and leading a normal life. His serious heart defect prevents him from doing this.

I salute Manie, Lyam and the other 632 children. I salute their parents too and if Glaxo are found guilty in all of these cases I shall be saluting them too... only that salute will be two fingered!

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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New Study Uncovers Paxil's Hidden Toxicity

As if we didn't know already (as if Glaxo didn't know all those years ago)

A new study carried out by the University of Utah has revealed what Glaxo have been hiding from the public for many years. The only people that really know the truth are the US Courts where information has been suppressed as part of settlement agreements made between Glaxo and Plaintiff lawyers.

In a nutshell, GSK attorneys come to a compromise when their case defending Paxil goes pear-shaped. They, of course, use all the tools at their disposal - the statute of limitations, whether or not a fetus is viable, ie, whether or not it can be regarded as a human at the time it was aborted - they also use many other points of law to defend their toxic blockbuster drug.

According to Neurotoxicology and Teratology, Volume 47, January–February 2015, mice exposed during development experienced a multitude of problems: males weighed less, had fewer offspring, dominated fewer territories and died at a higher rate. Females took longer to produce their first litters, had fewer pups and pups that were underweight.

The Paxil doses were relatively close to those prescribed for people.

In the study, researchers gave food laced with Paxil to 20 breeding pairs of mice for several weeks, until all had produced up to four litters. The offspring also ate Paxil-laced chow until they reached breeding age.

This from Newswise...

Researchers then released the exposed offspring into the competitive arena with the offspring of a control group of mice never exposed to Paxil. Groups consisted of eight males and 14 to 16 females, creating population densities comparable to those seen in the wild. The researchers started five such populations and kept them going for six months.

Males exposed to Paxil were about half as likely to control a territory. They also lagged behind control males in body weight throughout the weeks of competition and were more likely to die. Exposed males produced 44 percent fewer offspring. Exposed females showed no significant weight or mortality differences, but they produced half as many offspring as control females at the initial assessment. Their fecundity rebounded at later time points.

Are we surprised anymore?

Question is... Why has it taken so long for such a study to be carried out? In truth, it hasn't.

Here's a bit of history...

3-year-old Lyam Kilker was born with serious heart defects. While pregnant, Kilker's mother took the antidepressant paroxetine [Paxil]. The Jury's decision in this case was that Paxil was the causation of Lyam Kilker being born with heart defects. In other words, Paxil was deemed responsible as the agent that disturbed the development of an embryo or fetus.


The following was taken from the court transcript in the Kilker v GlaxoSmithKline trial. [Verbatim]

"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.

"Now, Shearing Plough, quite rightly, took their drug that they were thinking about taking to market to compete with Paxil, and even though it was just a possible teratogen, they scrapped their plans to take it to market and decided the risk was not worth the benefit."

Upon this revelation I emailed both Glaxo and the British drug regulator, the MHRA. All of that correspondence is featured in my book, The evidence, however, is clear, the Seroxat scandal. For those of you that don't have a copy there's an extract featuring that correspondence here.

No doubt medicine regulators around the globe will raise an eyebrow at the latest study by the University of Utah, they may shuffle uncomfortably... then ignore the findings. That's my experience of regulators. Quite why they are called regulators baffles me.

Paxil is just one example of a pill causing birth defects, there are many more, much of which are dished out to women because they have some form of dangerous depression during their pregnancy, a depression, that we are told, if left untreated can be passed on to the fetus.

Genius marketing folks...with the sole aim of making money...and lots of it.

Bob Fiddaman.

Related

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

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

Paroxetine - The Teratogenic Effect by Bob Fiddaman

Now there's a word, "Teratogenic" - one most of you will be unaware of - one that has caused me considerable confusion over the past few weeks. I shall explain.

The recent GSK vs Kilker case saw files flood the Internet, many of which, if not all, are featured on this blog and my sister blog, GlaxoSmithKline Internal Files

What I find astounding is that this word, "Teratogenic" and/or "Teratogen" often appears throughout the Kilker files. A quick search of the word/s simplifies it into laymans terms:

Teratogenic: Able to disturb the growth and development of an embryo or fetus.

Teratogen: Any agent that can disturb the development of an embryo or fetus. Teratogens may cause a birth defect in the child. Or a teratogen may halt the pregnancy outright. The classes of teratogens include radiation, maternal infections, chemicals, and drugs.

What has caused me much confusion over the past few weeks is the lack of help I have received trying to find out more about the paroxetine [Paxil, Seroxat] and teratogen link.

The Kilker case files show a link between paroxetine and its teratogenic effect, such a strong link that the jury in that case found that paroxetine was the causation of young Lyam Kilker being born with heart defects.

As a patient/concerned UK citizen I have tried to ask questions regarding this link.

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

GSK Press Release - Kilker Trial

The following is a statement from GSK regarding the Jury verdict in the recent Kilker v GSK trial.

It is taken from the US GSK website.

GSK Statement on Jury Verdict in Paxil Product Liability Trial in Philadelphia Court of Common Pleas

On October 13, 2009, a jury in the Philadelphia Court of Common Pleas returned a verdict against GlaxoSmithKline in a case alleging that Lyam Kilker was born with a rare heart defect as a result of his mother’s use of Paxil during pregnancy.

GlaxoSmithKline disagrees with the verdict and will appeal. While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy.

GlaxoSmithKline acted properly and responsibly in conducting its clinical trial program for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators. Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicine’s labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

US Media enquiries:

Nancy Pekarek

(919) 483 2839

Mary Anne Rhyne

(919) 483 2839

Kevin Colgan

(919) 483 2839

Sarah Alspach

(919) 483 2839



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

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.

Analogy

"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.

Japan

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