Monsanto Roundup Lawsuit

About Me
Image may contain: 1 person
Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Friday, April 26, 2013

Celexa/Lexapro... Or Your Money Back

Not for use in children and adolescents


Celexa [citalopram] and Lexapro [escitalopram] are two antidepressants in the family of SSRi's. Some would argue [I'm one of them] that both antidepressants are pretty much the same. Let's face it, Lexapro only ever came to market because the patent was running out on Celexa.

Forest Labs, the manufacturer, have argued that the two drugs differ, maybe so but the end result is the same particularly when it's been down to the marketing team of Forest Labs.

Once again, kids have been targeted despite these group of drugs bearing warnings that they were not recommended for pediatrics.

How do we know this for sure?




Well, in 2010 Forest Labs settled with the US government. Forest Labs were accused of illegally promoting Celexa for use in children and adolescents despite the fact it had not been approved for marketing in the United States.

In other words, they were promoting the use of Celexa in kids to doctors through "off-label" marketing.

We know how that works, right?

Kickbacks, holding back negative study results, ghostwritten papers, in general bending the law to suit their needs.

Forest Pharmaceuticals, a subsidiary of Forest Labs, also pled guilty to a whole range of underhand practices including misbranding Celexa by marketing it for use in children from 1998 to 2002.

With these two settlements Forest Labs and Forest Pharmaceuticals have paid out a wad of cash, moved on and now, it seems, it's business as usual.

But there's one final twist in the Forest saga.

Both Forest Labs and Forest Pharmaceuticals, because of their illegal promotion, now may have to reimburse the families of those who paid for prescriptions of Celexa and Lexapro. Rightly so too.

A consumer fraud class action is underway, meaning that if you as a parent of a child who took Celexa or Lexapro can claw back what you paid. Quite a hefty amount if your child was on either drug for a long time.

These types of consumer fraud cases need a lead plaintiff, someone that not only represents their child or children but one who represents the whole class action. It's like a lead case. Classic example here being the Kilker V GlaxoSmithKline case. Lyam Kilker was born with heart defects as were 800 other kids. Kilker et al represented the class action, they won the case against Glaxo which meant Glaxo settled the majority of other cases.

The Forest lawsuit is looking for additional class representatives. There are already some lead cases in places for many of the US states but more are needed. I'm pretty sure those that represent a group action are compensated handsomely, and why not - putting yourself out front deserves to be rewarded.

I think it's important to keep the pressure on Forest. Settling with the government is one thing, now it's time to settle with the people they duped - the public.

A cynic would suggest that this is just about the dollar, they'd be wrong. This is about getting your teeth into a pharmaceutical company and biting them so hard that they think twice about doing any dirty deeds again.

If I had my way I'd put those responsible behind bars, to promote something that is harmful to any human is wrong, to promote it for children is despicable and abhorrent. Sadly, the only way to hurt big bad pharma is in the pocket and media.

Forest have made two settlements, they should now cough up to those who matter, the parents who forked out money for weekly prescriptions of Celexa and Lexapro.

The fact that some kids never experienced any adverse reaction is irrelevant here. The fact is both Forest Labs and Forest Pharmaceuticals played Russian roulette with children and for that two things should happen.

1. They should be held accountable.

2. They should compensate those they played Russian roulette with.

Both Forest Labs and Forest Pharmaceuticals made huge profit from Celexa and Lexapro, they did so by basically using children as guinea pigs, they did so by wining and dining doctors so they would prescribe more Celexa and Lexapro to children, they did so by withholding negative data about both drugs, data that showed that Celexa was no more effective than placebo for pediatric use.

Why should any company, be they pharmaceutical or a fizzy soda drinks company benefit from putting children's lives at danger?

So, did you or do you know anyone that paid for prescriptions for their children and/or adolescents for Celexa and Lexapro between 2001 and the present day? If so, then you may want to represent a class action in your state.

You can find out more information by calling 800-827-0087 or by filling in an online form HERE.

Forest Labs and Forest Pharmaceuticals should not benefit from your purse, particularly when the products they promoted for children and adolescents were actually dangerous for this vulnerable population. Their shareholders should not benefit from your purse either, namely, Wellington Management Company, LLP, Icahn Associates Corp and many more.

The full complaint can be read, in PDF form, HERE.


Bob Fiddaman




JOIN THE FIDDAMAN BLOG ON FACEBOOK









Wednesday, April 24, 2013

Global Medical (Mis) Information



I was sent a private email on Twitter a few days ago from Global Medical Education, known on Twitter as @GlobalMedEd. The blurb on their Twitter page reads, "GME is an online medical education resource that provides evidence-based medical education from faculty at Columbia, Duke, Harvard, Oxford, Stanford and more."

The content of the email was baffling considering I've been blogging about the dangers of antidepressants for over 7 years.

We're offering FREE access to 700 unbiased, evidence-based psychiatric videos Code: GMETwitter http://bit.ly/Pzvkhs  Limited time offer.

So, I checked out the GME website and watched a few of the videos on offer. Ones about ADHD, bipolar, depression and many other box-ticking illnesses.

I publicly tweeted GME and asked the following:



A day later they replied with...



So, I checked out the video.

I watched it... then I watched it again... and to be sure I wasn't hearing things I watched it for a third time.




The video features Manpreet K. Singh an Assistant Professor, Department of Psychiatry and Behavioral Sciences and Associate Director, Pediatric Bipolar Disorders Clinic. She's also a Pediatric/Adolescent Psychiatrist practicing from the Stanford University School of Medicine

I'll dissect Singh later in this post, first I want to highlight the video GME entitled, Can Antidepressants Cause Suicidality in Children and Adolescents?

There's even a slide show a separate audio commentary if watching videos isn't your thing.

Singh starts off by telling us that suicidal thoughts and behaviours are more common in adolescence than at any other time, but completion is more common among adults. Not in NZ where the highest suicide rates are in the 15-19 age group. She goes on to tell us that untreated depression increases the risk of suicide.

One can assume here that Singh is setting her stall.

She juxtaposes the FDA decision to add a black box warning to antidepressants with the following...

There were no cases of suicide in the cases they [FDA] studied. Autopsies of teenagers who have committed suicide show that very few of them had traces of an antidepressant, making the link between antidepressant use and suicide even weaker.
She then tells us...
Between 1992 and 2001, there was a large increase in the number of adolescents being prescribed antidepressants.

Adding...

But during that time the rate of suicide among American youth ages 10-19 dropped by more than 25%. This was the first time in nearly 50 years that the suicide rate declined in young people.

She makes no reference to the study, one can only assume she is refering to the [now debunked] studies of Robert Gibbons. His paper regarding suicide rates was described in the BMJ as “astonishing,” “misleading,” and “reckless.” Even one of his own researchers, Ron Herings, claimed, findings are “not right” and that it “ doesn't follow from the data, it is not true and serves just to scare people. It is hard to admit this, as I am one of the authors of the article and I attached my name to it …” [1]

Bob Whittaker, an award winning journalist and author, takes up the story of Gibbons here. Retired psychiatrist, Mickey Nardo, also highlights the flaws of Gibbons here.

Anyway, back to the video... or rather the star of the video, Manpreet K. Singh [Fig 1]

Fig 1

Her CV, at first glance, is impressive...if the field of psychiatry impresses you, that is. However, Singh fails to mention on her CV or the video message on GME that she has links to the pharmaceutical industry. She has, however, disclosed relevant financial relationships in various psychiatric journals. In 2007, for example, she disclosed she had relevant financial relationships with AstraZeneca, Otsuka, and Pfizer [2]. Also in 2007 she disclosed that she serves as a subinvestigator for Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Janssen, Pfizer, Abbott, and Shire Pharmaceuticals. [3]

Jump to 2010 and she declares that she has no financial ties or conflicts of interest to disclose. [4] Yet Pro Publica have her down as receiving $1,209 from Pfizer in 2010. [5]

As for the claims she makes in the video, let's just take a look at them once again.

There were no cases of suicide in the cases they [FDA] studied. Autopsies of teenagers who have committed suicide show that very few of them had traces of an antidepressant, making the link between antidepressant use and suicide even weaker.

What Singh fails to mention is the FDA were powerless to track down a large number of subjects in the clinical trials that were lost to follow up [IE; dropped out of the studies as a result of adverse reactions] These subjects were never followed up to see if they killed themselves. She also blatantly misses the point that when patients are prescribed antidepressants they are still part of a clinical trial, it's called the post-marketing phase.

Singh also fails to mention that the autopsies was just one method the FDA used to determine the risk factor of antidepressant use in adolescents. The FDA actually looked at data obtained from their British counterpart, the MHRA, who, after analyzing studies done by GlaxoSmithKline, found that  “These data do not demonstrate efficacy in depressive illness in this age group and show an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behaviour in the Seroxat group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater with Seroxat [Paxil] compared to placebo.” [6]

Once the Paxil danger had hit the streets Wyeth soon announced via a letter warning physicians that venlafaxine (Effexor and Effexor XR) was associated with an increased rate of hostility and suicidal ideation in pediatric clinical trials.

To what length did the FDA go to see if there were traces of antidepressants? What tests were carried out and how stringent were they?

An independent report by Janne Larsson, analyzed the 2007 suicide data documented by the Swedish National Board of Health and Welfare (NBHW) and from the regional departments of the National Board of Forensic Medicine. The data, not readily available to the public, was obtained under Freedom of Information requests. [7]


In 2007, there were 1,126 suicides in Sweden (325 women and 801 men).  Autopsy reports were made for 1,109 of the suicides, which is 98%.

The majority of persons who died by suicide in Sweden in 2007 had received extensive treatment with psychiatric drugs within a year of death by suicide.

Janne Larrson, a Swedish investigative journalist, had requested the records under the Freedom of Information Act. He learned that , "In the forensic toxicological analyses traces of psychiatric drugs were found in 575 persons (52%) of the 1109 analyses done. Traces of antidepressant drugs were found in 132 (41%) of the women investigated." 

None of the documented 1,126 suicides were reported to the agency that maintains adverse drug reaction data.

These were adults.

If questioning the methods of the FDA analyzing teenage autopsies one need look no further than the case of 17 year old Toran Henry. Toran had been prescribed the generic form of Prozac [Fluox]. A change in mood, abnormal behaviour culminating in suicide - this just 15 days after he had first ingested Fluox.

During the inquest of Toran, his mother, Maria, called for a toxicology report. The first, taken on the 28th March 2008 found only alcohol in Toran's system. Knowing her son was taking Fluox at the time of his death Maria requested a further toxicology report. In the 14th April 2008 a second test was carried out. Here's a direct quote from the inquest transcript:

"No fluoxetine was detected in the blood, this analytical technique will detect therapeutic use of this antidepressant drug."
Once again Maria knew this was wrong. She pushed for a third toxicology report.

On 23rd July 2008 a third test was carried out. This from the inquest transcript:

"Blood was analyzed for the detection of fluoxetine - fluoxetine detected - 3rd test was carried out as requested by Ms Bradshaw, Toran's mom"
Three blood tests, the second apparently being so robust that "this analytical technique will detect therapeutic use of this antidepressant drug."

Truth is, it didn't.

The truth was outed but it took a grieving mother to out that truth.

For the purpose of this argument let's assume that 17 year old Toran Henry was a black box retrieved at the site of an airline crash. Let's assume that investigators found nothing within the black box that suggested any malfunction in the plane. Let's assume that after a second investigation of the black box, a more robust one, that, once again, nothing was found. Now, let's assume that after a third investigation something was found, that something was the cause of the airline crash. Would we, as members of the public, have faith in investigators one and two?

Five years down the line and both the New Zealand government and Mylan, the pharmaceutical company that manufacture Fluox, have admitted that the probable cause of Toran's suicide was down to the Fluox he ingested. [8] [9]

One would have to question then the methods used by the FDA in determining whether or not antidepressants were found in the autopsies they studied.

There are many tests carried out for toxicology, we've seen what happened in the case of Toran Henry. Were the FDA relying on autopsies that carried out toxicology tests just like the first two methods in the case of Toran Henry? I'm surprised nobody has asked them this.

There are a number of tests that can be carried out. Here's some for just one of the SSRi's, Prozac. Which ones did the autopsies the FDA studies use? Could it be argued that there were few adolescents with antidepressants in their system because the wrong type of toxicology test was carried out? It's a fair enough question, right?








Moving on the Singh's other claim in her 4 minute video...


Between 1992 and 2001, there was a large increase in the number of adolescents being prescribed antidepressants. But during that time the rate of suicide among American youth ages 10-19 dropped by more than 25%. This was the first time in nearly 50 years that the suicide rate declined in young people.


I'll use simple tit-for-tat here.

SSRi's were introduced to New Zealand in 1989. The table [Fig 2] shows a general increase in suicides since their introduction.

Fig 2
To take this one step further, let's now take a look at 2008 onwards.

Here's the prescription rates for antidepressants in NZ - 2008/2012 [Fig 3]

Fig 3

And now let's look at the NZ suicide statistics.


2008  - 540              
2009  - 531
2010  - 541
2011  - 558
2012  - 547


So many antidepressant prescriptions, so many suicides.

On top of this myself and Maria Bradshaw [CASPER] are in the middle of writing up a cohort study. We have, under the freedom of information act, obtained suicide data from the same district health boards [DHB's] seen in Fig 3. Initial findings see 90% of those who died under the care of DHB services were on or were recently on psychiatric medication at the time of their suicide. The figures we have will be made public once we have completed our study.

As for Global Medical Education and Manpreet K. Singh, I believe the information they provide with regard to suicidality in adolescents on antidepressants is very misleading, very one-sided and extremely dangerous.

Watching the performance of Singh left a terrible feeling of helplessness in the pit of my stomach. For a professional to go against the regulators and manufacturers of these dangerous medications means that less internet savvy members of the public may find themselves one day Googling whether or not antidepressants are safe in children and adolescents. Her biased [read from an auto-cue] performance may convince parents that antidepressants are safe when used by this vulnerable population. She may also have convinced healthcare professionals.

Here's the video

video



Global Medical Education carry the disclaimer at the foot of their website, "All material on this website is protected by copyright, Copyright © 2013 by GME Inc. This website also contains material copyrighted by 3rd parties."

If they feel I have infringed their copyright by posting their video on my blog then I request that they email me, they can do so by using the 'Contact' tab at the top of this blog.

Worryingly, Global Medical Education have over 5,000 followers on Twitter. If all of those 5,000 + received a private message from them, as I did, then it would appear that they are pushing the promotion of their website to all and sundry... even to those who vehemently believe that antidepressants can cause suicide.




Bob Fiddaman


[1] Coincidence a fine thing - David Healy [Link]
[2] Pharmacotherapy for Child and Adolescent Mood Disorders
Manpreet K. Singh, MD, MS; Jonathan C. Pfeifer, MD, MS; Drew Barzman, MD; Robert A. Kowatch, MD, PhD; Melissa P. DelBello, MD, MS [Link]
[3] Journal of the American Academy of Child & Adolescent Psychiatry Volume 46, Issue 3 , Pages 306-307, March 2007 [Link]
[4] Neural Correlates of Response Inhibition in Pediatric Bipolar Disorder
Manpreet K. Singh, M.D., M.S, Kiki D. Chang, M.D. Paul Mazaika, Ph.D., Amy Garrett, Ph.D., Nancy Adleman, Ph.D., Ryan Kelley, B.S., Meghan Howe, M.S.W., and Allan Reiss, M.D. [Link]
[5] Payment Disclosure - Singh, Manpreet, Kaur [Link]
[6] WHO Drug Information Vol. 17, No. 2, 2003 [Link]
[7] Psychiatric drugs & suicide in Sweden 2007 - Larsson [Link]
[8] Mylan's Fluox Can Probably Induce Suicide, admit Mylan [Link]
[9] CARM Assessment of Toran Henry's suicide [Link]






JOIN THE FIDDAMAN BLOG ON FACEBOOK










Sunday, April 21, 2013

Canadian Network Report on Big Bad Pharma



Well worth watching.

As usual the pharmaceutical companies mentioned (Eli Lilly, Pfizer and GlaxoSmithKline) in the 16×9 investigation failed to appear in front of camera, opting instead for the tired old "Our drugs are safe and effective" kind of statement.

The regulators come under fire too. Footage includes Pete Breggin and David Healy.

Good to see Canadian TV highlighting the flaws of antidepressants... only wish their limp-wristed regulator, Health Canada, were the same.




**If you can't get the video player to load you can watch it via the TV network [HERE]
Bob Fiddaman






JOIN THE FIDDAMAN BLOG ON FACEBOOK




Saturday, April 20, 2013

Glaxo Add to Their List of Misdemeanours

GSK's addictive antidepressant, Seroxat


One would have thought that British pharmaceutical giant would still be licking their wounds after the record fine of $3billion they dished out a couple of months ago.

No sooner had that particular scab healed Glaxo find themselves [once again] in hot water.

And it's Seroxat that rears its ugly head [once again]

This time Glaxo haven't been accused of pushing it on kids via ghostwritten articles or Madonna tickets for doctors... they've been accused of not allowing other companies to get in on their act.

How did they do this?

I'll explain.



When Seroxat first hit Britain it did so for only a limited time. When pharmaceutical companies bring a drug to market they have the sole rights to that drug until their patent expires. Then, and only then, can other pharmaceutical companies come along and use the compound [paroxetine]. Pharmaceutical companies don't like this so are always devising ways to extend their patent. A clinical trial that tests the drug in kids will give them that extension and increase profits.

So, Glaxo's patent for Seroxat was coming to an end. Three other pharmaceutical companies were waiting in the wings to produce a generic version of Seroxat, a version that would be sold at a much cheaper price and therefore hitting Seroxat [manufactured solely by GSK] sales.

So here's what Glaxo did [ahem allegedly]

Glaxo made “substantial payments” to Alpharma, Generics UK and Norton Healthcare to stop them releasing version of its paroxetine. This would have meant that Glaxo would have been able to profit from the sale of Seroxat and, at the same time, would have meant that their shareholders and investors would have been kept sweet.

Who accuses them of this?

Well, it's not an activist blogger, it's The Office of Fair Trading [OFT] whose job is to make sure that consumers have as much choice as possible across all the different sectors of the marketplace.

In a statement the OFT "alleges GlaxoSmithKline (GSK) concluded agreements which infringed competition law with each of Alpharma Limited (Alpharma), Generics (UK) Limited (GUK) and Norton Healthcare Limited (IVAX) ('the generic companies'), over the supply of paroxetine in the UK. The OFT also alleges GSK's conduct amounted to an abuse of a dominant position in the same market."

The statement adds:

"The OFT's provisional view is that these agreements included substantial payments from GSK to the generic companies in return for their commitment to delay their plans to supply paroxetine independently."

GSK making substantial payments around Seroxat, surely not.

The allegations in this case concern so called 'pay for delay' agreements, where a manufacturer of branded pharmaceuticals, in this instance GlaxoSmithKline, makes payments to a generic company in return for that generic company agreeing to delay its independent entry into the market for a product, in this instance paroxetine.

Glaxo have responded in usual style. A statement on the GSK website stresses that "GSK supports fair competition and we very strongly believe that we acted within the law"

No mention or excuse that this was just part of an era.

Here's how the BBC broke the news.




Jensen Button and the McLaren team must be wondering if the sponsorship deal with Glaxo was such a great idea after all. [Back story]

Some of the major GSK shareholders today include Dodge & Cox Stock, Vanguard PRIMECAP Inv and the Royal Bank Of Canada.


Bob Fiddaman






JOIN THE FIDDAMAN BLOG ON FACEBOOK




Friday, April 19, 2013

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






JOIN THE FIDDAMAN BLOG ON FACEBOOK



Monday, April 15, 2013

First do no harm... providing it's no longer than 8 minutes

Dr Bhamjee, caused controversy back in 2011 when he called on the Irish Government to add lithium salts to the public water



Dr. Moosajee Bhamjee, a soon to be retired psychiatrist from Ireland, showed exactly why the profession of psychiatry needs to take a long, hard look at itself when he was a guest on the George Hook radio show in Ireland on Thursday [11 April]

Hook had been contacted by Irish blogger, Leonie Fennell regarding a GP he had interviewed a week previously on his show.

The GP, Dr. Ciara Kelly, offered her opinion to a recent article that had appeared in the Irish press [Irish Examiner] that highlighted how GP's handed out antidepressant medication at the drop of a coin. An undercover journalism student, Niamh Drohan, had approached 7 GP's in Ireland and told them she was suffering from stress and anxiety problems from her final year in college. On each visit a prescription for an antidepressant was written for Drohan. Her article ‘Depressing Truth about Treating Depression In The Young’ can be viewed here. Fennell gives her take on it here.

Hook's interview with Ciara Kelly enraged Fennell so much that she emailed the show to set the record straight. Kelly had claimed , during the course of her interview with Hook, that “the drugs themselves are not dangerous, they’re not addictive, they’re not even dangerous at high levels of overdose.”

Fennell's son, Shane, took 39 Cipramil in 17 days and his toxicology report showed a ‘toxic to fatal’ amount in his system. On the 17th day Shane, under the influence of the antidepressant citalopram, killed himself and another man. Podcast with Leonie Fennell here goes into more detail.

Fennell, along with antidepressant expert Prof. David Healy, were invited by Hook to offer their opinion as was Dr. Moosajee Bhamjee.

The interview [below] is interesting in as much that Bhamjee argues that in his 40 years as a healthcare professional he has never seen any patient who has experienced aggressiveness on these types of drugs. He also argues that Dr's only get an 8 minute slot to determine if someone is mentally ill and needs prescription medication. And there I was thinking that the Hippocratic oath taken by Dr's carried no disclaimers!


Bhamjee, caused controversy back in 2011 when he called on the Irish Government to add lithium salts to the public water supply in a bid to lower the suicide rate and depression among the general population.

Anyway... here's the debate from the Hook show.



If you are having trouble with the audio player then the audio can be downloaded direct to your computer by right clicking and 'save as' HERE

Leonie Fennell's blog




Bob Fiddaman




JOIN THE FIDDAMAN BLOG ON FACEBOOK


Tuesday, April 09, 2013

Cellphones, Guns and Antidepressants




When I'm not researching or writing, I'm learning the guitar. When I'm not learning the guitar, I'm reading. When I'm not reading words related to the work I do, I'm escaping with novels, mainly John Grisham, whose words still relate to the work that I do.

A breath of fresh air then would describe the latest novel I have just finished.

'Cell' by Stephen King isn't one of his classics but it did get me thinking that there's a book out there ready to be written along the same lines as 'Cell'.

For those of you who haven't read King's 'Cell' it's book of pure fiction whereby a pulse is sent through satellites to owners of cell phones... or mobile phones as they are known outside of America. The pulse sent makes people crazy who in turn kill one another... they don't know why, they just act on the pulse.

So, why am I wring about this?

It got me thinking.

Let's say each time we picked up a gun which had that same [pulse] - that urge to kill. It was the gun that, somehow, had been coated with a substance that leaked into the pores of the skin and made the person holding it want to go out and kill. Pure fiction, I know but it echoes the work of King.

Cast aside the work of fiction for one moment.

Let's put together the work of another novel.

Let's just assume for one minute that there's a pill that makes people crazy, let's assume that those taking the pill want to go out and kill. Let's assume that there's a power behind the mass production and ingestion of the pill.

You get where I'm coming from yet?



A book about a pulse being sent down a phone line... sent to parts of the brain that makes people crazy is believable because authors like Stephen King have a great knack of making fiction become reality. If he were to write about a gun with a special coating that also made people crazy then I'm sure he could do it just as well as 'Cell'.

Thing is...

A book about a pill making people crazy and turning them into killers wouldn't really be that sexy... it wouldn't be fiction either.

We could take it a step further than King did in 'Cell'. King's characters got the pulse and went on a killing spree. The characters in our book, 'Pill' could not only kill others they could also kill themselves.

Now that would be just too far-fetched, right?

There's a novel waiting to be written. It could, if desired, be set in New Zealand or even Bridgend in Wales. Of course in our book a pill wouldn't almost wipe out the human race as we know it. The Pill would just contribute to a certain amount of deaths and/or slayings, just enough to stop people from making the link - just enough so that the regulators of medicines can dispute any link and keep the pill on the shelves.

Sounds crazy, eh?


1988 - Laurie Wasserman Dann walked into a second grade classroom at Hubbard Woods School in Winnetka, Illinois carrying three pistols and began shooting children, killing an eight-year-old boy - Nicholas Corwin - and wounding five others before fleeing. She entered a nearby house where she shot and wounded a 20-year-old man before killing herself. Dann was taking the antidepressant Anafranil [clomipramine] for Obsessive Compulsive Disorder. [Not a Stephen King novel - Link]

1992 -  Stephen Leith, a school teacher shot and killed his superintendent at school. Leith, from prison, later wrote to the FDA explaining how Prozac had made him hostile. He writes, "My temper became shorter and anything could set me off. My anger burned so intensely it was scary. I had never experienced anything like it either before going on PROZAC or since I was taken off of it. I had a headache all the time and was confused much of the time. Something inside felt as if it wanted to crawl out of me, leaving a shell behind; my brain felt like it was sloshing in my skull. After nearly two years of decline, I snapped and killed the Superintendent at a grievance meeting pertaining to my bizarre behavior". [Not a Stephen King novel - Link]

In the same year Calvin Charles Bell opened fire at the Southwest Houston School in Texas. Bell had apparently been "upset about his second-grader's progress report". Just like Leith and Dann, Bell was taking psychiatric medication. [Not a Stephen King novel - Link]

1995 -Toby R. Sincino, a 15 year old, shooting dead a teacher before killing himself. Toby's aunt, Carolyn McCreary, said, "he had been undergoing counseling with the Department of Mental Health and was taking medicine for emotional problems."  [Not a Stephen King novel - Link]

1999 - Of the many number of school shootings none have been more reported than Columbine where 15 died and 24 were injured. Eric Harris, one of the shooters, "was taking Zoloft before he switched to Luvox and that he reported 'feeling better' when discontinuing the Zoloft before starting the Luvox." [Not a Stephen King novel - Link]

2005 - Jeffrey Weise first murdered his grandfather before going on a  a shooting spree where 9 people were killed and 7 were left wounded. Weise  had increased his dosage of Prozac a week prior to the shootings. [Not a Stephen King novel - Link]

There are many more.

In May 2012, an article in People magazine reported that between January 2007 and February 2012, 79 people in the Bridgend area of South Wales had taken their own lives by hanging. AntiDepAware author draws comparisons to the antidepressant link here.


I currently live with my partner Maria Bradshaw out here in New Zealand. Maria's son, Toran, killed himself after just 15 days on Prozac. The New Zealand government and Mylan, the manufacturer of the generic form of Prozac Toran was taking have both concluded that it was probable that Prozac induced his suicide.

Good friends of mine Leonie Fennell and Tony Donnolly lost their son, Shane Clancy. Shane, like many of the above, went berserk killing a young man before stabbing himself in the chest 19 times, resulting in his death. Three weeks prior Shane had been prescribed Celexa, known as Cipramil in Europe.

Brennan McCartney was just 18 years old when in November 2010, he was prescribed Lexapro [known as Cipralex in Canada]. 4 days later Brennan hanged himself.

Again, there are many more.

I'm currently reading King's novella, Rita Hayworth and the Shawshank Redemption, a small story in King's Different Seasons, a collection of short stories. Rita Hayworth and the Shawshank Redemption later went on to become a movie, The Shawshank Redemption. The screenplay by Frank Darabont being, in my opinion, much better than the original work of King.

Shawshank is one of my favorite movies, I love it all, the spine-tingling narration of Morgan Freeman [Red], the innocence of Andy Dufresne played superbly by Tim Robbins. The brutal warden and guard, Samuel Norton [Bob Gunton] and Byron Hadley [Clancy Brown] whose individual downfall was most welcoming. The message of hope Shawshank gives and its hinting of David v Goliath. Everything including the moving musical score by Thomas Newman.

Ironically, back in 2010, I created a video using the score from The Shawshank Redemption.

It fits well with this post.



video




It's a crazy world that we live in... even without pulses and coated guns.

Bob Fiddaman




JOIN THE FIDDAMAN BLOG ON FACEBOOK


Friday, April 05, 2013

Alistair Benbow on Seroxat/Paxil Suicide




As a follow on from my last post, Alistair Benbow on Seroxat/Paxil Addiction, I now turn my attention to part two of the interview with Benbow, much of which never went to air on the BBC.

For those that don't know, Alistair Benbow was the spokesperson, nae mouthpiece, for GlaxoSmithKline any time an issue of Seroxat [Paxil] was raised in the media.

Here's Benbow being grilled by BBC's Shelley Jofre over Seroxat and the suicide link.

The transcript was downloaded via the Drug Industry Document Archive


Key:

Q = Jofre
A = Benbow


Transcript GSK Tape - Panorama Interview - Dr Alastair Benbow 9 October 2002




Q. Let us move on. What has the company done about the Wyoming verdict?

A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed...


Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.

A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.


Q. So the jurors got it wrong!

A. No, I am not saying that. What I am saying - as I have said before - is that there is a confidentiality agreement between the family and GSK in this matter and I cannot comment on the specifics of this but we remain firmly convinced that Seroxat did not cause the tragic events in this case.


Q. It was pretty clear-cut. There was nothing else to explain his behaviour. He had only been on the drug two days and he clearly had a reaction that threw him into mental turmoil and made him behave in this way.

A. Yes, but there is a lot of speculation in the question you asked there but as I said I cannot comment specifically on this case because of a confidentiality agreement between the family and GSK. What I can say is that looking at all the data and the clinical trials there is no reliable evidence that Seroxat causes violence, aggression or homicide.


Q. All the evidence was produced in the trial. I am sure your company more or less produced the best evidence that was available. The jurors decided Seroxat was responsible for those four deaths and that is pretty serious.

A. As I have said before, I cannot comment on the specifics of the case...


Q. You cannot tell me that the clinical trials support Seroxat as not being linked to aggression or suicide?

A. Yes, I can say that. The clinical trial data and spontaneous adverse event data for reporting over the last ten years since Seroxat was made available in the UK do not support the finding that Seroxat causes aggression, violence or homicide.


Q. All of this data was presented to the jurors so they had ample opportunity to hear arguments on both sides and they felt Seroxat was responsible for the deaths.

A. As I say I cannot comment on the legal situation because of a confidentiality...


Q. I am not asking you to comment on the legal situation. I am asking you to comment on the fact that your company's drug was found responsible for four deaths.

A. As I said, I cannot comment on the specific situation but what I can say, quite clearly, is that when you look at the data from clinical trials and from the data in use in tens of millions of patients in 1999 that there is no reliable evidence that Seroxat causes violence, homicide or aggression.


Q. Is your company just going to ignore this verdict as if it never happened?

A. No we take very seriously any event that occurs when patients are taken off...


Q. What have you done to make sure that this does not happen again?

A. We have looked very, very carefully at the data, and as I say the data clearly shows that there is no reliable evidence that Seroxat causes violence, aggression or homicide.


Q. What does the warning in the patient leaflet mean then?

A. What do you mean?


Q. The warning about self-harm and suicide that is on the Seroxat leaflet, what does it mean?

A. As you will know, in patients who are depressed there is a significant risk of suicide and self-harm. That risk of suicide is at its worst when people have their worst depression, and that is often when people go to the doctor...


Q. Why would the risk of suicide increase once they start taking Seroxat?

A. No, I am not saying it increases when they start to take Seroxat; I am saying people are at risk of suicide early in treatment because it takes a while for an anti-depressant to work.


Q. The suggestion in the warning is that there is an increased risk in the first few weeks of being on Seroxat, but you say it is nothing to do with your drug?

A. What I am saying is that there is an increased risk of suicide early in the treatment of depression. Whatever the treatment, or indeed if there is no treatment there is an increased risk of suicide, and this is a very...


Q. So it is just a co-incidence that the increased risk of suicide starts when they start taking Seroxat?

A. No, what I am saying is that there is an increased risk of suicide even if patients receive no therapy. This is a fact of people who have depression. The reality is that many people with a severe depression have a very low mood and loss of energy. As people start to recover their energy and mood encourages...


Q. But they are not recovering, you say, until a few weeks after they start the Seroxat.

A. Early on in treatment the major affects of anti-depressants take a week or two to start, but the reality is that energy levels are one of the first things that start to improve, but mood comes later.


Q. Is it not that they get agitated?

A. Not at all. Not at all.


Q. It sounds to me here as though you are trying to have it both ways. You are trying to say the risk increases when you start taking the drug but it is nothing to do with the drug. It is meaningless warning.

A. No the warning is there, and has been agreed with the regulatory authorities, and it is basically to tell doctors, 'Look, you have a patient who is depressed. They are at risk of suicide. Don't just think just because you have started them on anti-depressants that they are not going to remain at risk of suicide immediately. The fact is that antidepressants take a while to work. If you look at the data what does the data show? The data shows that Seroxat reduces suicidal ?hydration and thought. Over the past ten years - or the ten years between 1990 and 2000 - with the increasing use of antidepressants, suicide rates in England and Wales have fallen by 15%...


Q. Are you taking credit for that?

A. I am saying that the increased used of anti-depressants, the better diagnosis of depression and the better treatment that is available - yes, that has contributed to the fall in suicide rates.


Q. Perhaps over the long term drugs like Seroxat are useful for avoiding suicide and reducing suicide rates but what we are talking about is a window in the first few weeks where there is quite a lot of evidence that people can become agitated, restless and anxious. It seems to correspond exactly with the period that you are saying there might be an increased risk of suicide but you are saying it is nothing to do with your drug.

A. No, I must disagree with the comments you made. There is not a lot of evidence to suggest that patients are getting agitated and restless and anxious. The reality is that anti-depressants do take a short while to work, and during that first few weeks, when patients are taking therapy, doctors should be aware that patients are at risk of suicide, because of their underlying depression.


Q. So it is not an increased risk. I do not understand what you are saying. If you are saying, 'Until the anti-depressant starts working they are at the same risk of suicide as they have always been' then that is one thing. However, your warning says there is an increased risk of suicide...

A. What I am saying is the greatest risk to patients of committing suicide is in those who are severely depressed.


Q. But in those first few weeks of... [talking simultaneously] start Seroxat?

A. No, the most severely depressed patients are those that have just presented their doctor and just started on therapy.


Q. Of course not everyone take Seroxat for depression and we have spoken to someone who took Seroxat for panic attacks and he began to self-harm in the first few weeks of taking it, something he had never even dreamed of doing before.

A. Seroxat is indeed available for a range of depression and anxiety related disorders, all have clear criteria for laying down exactly what the conditions are. There is a range of different conditions - panic disorder, obsessive-compulsive disorder, social anxiety disorder etc. Many of them are associated with depression and the same patients will be at risk of suicide and...


Q. Again is it just a coincidence this behaviour would start a few weeks after taking Seroxat?

A. No I am not saying it is a coincidence. I am saying it is a reality of depression and other related disorders...


Q. Panic attacks?

A. Yes, panic attacks and...

Q. I thought that is a link to self-harm.

A. Panic attacks are linked to depression, which is linked to self-harm.

**At this point Jofre pushes home the point about Seroxat withdrawal - She then continues with...


Q. Well, let us move on. Here is a drug that is linked to suicide and self-harm, a drug that thousands of people say they are addicted to; do you seriously think it should be given to children?

A. Let me just correct something in your question. There are a number of allegations you made there none of which are correct. In terms of whether we think Seroxat should be made available to children, absolutely. Two percent of children, 4% of adolescents, will develop depression. The adolescents are at particular risk of suicide.


Q. You think this is safe for children?

A. I think we need to do the trials to determine this. We have an obligation to make our medicines available to those patients at need. Adolescents are some of the patients who are most at need of anti-depressants. Suicide in adolescents is the third leading cause of death. Do not trivialise depression for those patients. We have a strong obligation to study our medicine in these patients to see if we can help them.


Q. In a recent study that Glaxo funded more than 10% of children developed psychiatric problems within eight weeks of taking Seroxat.

A. I think you will have to tell me a little more about the specific study so that I can understand your question.


Q. It was funded by Glaxo and carried out in America - the biggest ever study of Paxil in depressed children and more than 10% of children developed psychiatric problems within a few weeks of taking Seroxat.

A. I think in any study a proportion of patients (as in this particular study) where patients were either taking Seroxat, or Imipramine, or a placebo, a proportion of patients will develop adverse effects in the course of the study.


Q. There were far more children on Seroxat than on the other drug, or on sugar pills who developed these psychiatric problems.

A. There are a number of different elements that you lump together in psychiatric disorders.


Q. I will run through the list of problems if you like. Five of the children suffered suicidal thoughts and gestures. There was aggressiveness. There were behavioural problems at school. None of this sounds very safe; it all sounds quite worrying for the children who are on Seroxat.

A. Actually not because some of those symptoms were also seen on the patients taking Imipramine and placebos.


Q. Not as frequently.

A. Maybe not as frequently, but they still suffered. This is typical of the sort of symptoms that occur in this population of patients. This is a difficult population to treat and you will be aware that for many medicines there is no licensed implication for use in children so much of prescribing in children is done off-label. We firmly believe that we have an obligation to study our medicine to treat population to examine the safety and the efficacy of that medicine.


Q. I appreciate that but there were many problems on Seroxat than on the other drug or the sugar pills.

A. Actually the majority of those side effects were relatively minor.


Q. No, a lot of these children were hospitalised it was so serious.

A. If you look at the proportion of patients who withdrew from therapy - and you can see less than 10% had to withdraw from Seroxat - more than 30% withdrew from the other active therapy and just under 10% withdrew from the dummy.


Q. It is heart complaints with the other drug, and I understand that, but-

A. But that is the sort of therapy that is the alternative, which is why it is very important that we study Seroxat in this group of children who are most at risk from suicide.


Q. What we are talking about here though are psychiatric side effects, the sorts of side effects that can lead to suicide and there were far more children on Seroxat suffering these problems than on the other drug or sugar pills.

A. What you are trying to do is make a link here with the adult data. The adult data clearly shows that there is no reliable scientific evidence that Seroxat causes suicide.


Q. But why should it be that so many more children should suffer these side effects on Seroxat than the other drug or sugar pills.

A. Actually, if you look at the more serious of those side effects the number difference was very small, and the sort that you would expect to see in clinical trials. On one trial there may be more than on another, in another it will go the other way.


Q. And for the 10% of the children on Seroxat who had these side effects you are not worried that it was caused by the drug?

A. The vast majority of these patients did not have side effects significantly enough to withdraw from the treatment. The reality is that in this population depression is an extremely serious condition and in many cases leads to suicide.


Q. I appreciate that.

A. Are we worried by the side effect profile? We take the safety of our medicines extremely seriously and we will look very carefully at this, and the combination of other data, to decide whether this medicine is suitable for children. My belief is that it will be but because there is a lack of treatment for this serious condition that this medicine will be suitable for a range of children as well as adults.


Q. You cannot be sure that the 10% of children on Seroxat who suffered these problems did not suffer them because of Seroxat can you? You cannot be sure about that.

A. One can never be sure of anything in medicine, but just because you take a medicine and you get an effect does not mean to say cause and effect because the same sort of symptoms occur with the dummy pills.


Q. That is why if you compare it to another drug and the sugar pills, in that comparison Seroxat was much worse.

A. In that comparison the proportion of patients withdrawing from the study due to adverse events was much lower on Seroxat than one of the other potential treatments available.

Q. There are 60 psychiatric side effects - the sorts of side effects that are linked with suicide and self-harm.

A. Let us look at the totality of the adverse event profile because it is the total risk and input that is important.


Q. We are considering the link with suicide, and this evidence points very strongly to the fact that more children are suicidal and had suicidal gestures in fact on Seroxat than the other drug.

A. With respect the totality of the data is important. What you are talking about are five patients out of the 275 on Seroxat, three patients on Imipramine. That difference is not significant and one patient had a placebo.


Q. No, I am talking about five children. The figures are-

A. I have given you the figures. Five on Seroxat, three on Imipramine and one on placebo.


Q. There were children out of 93 children on Seroxat who had suicidal thoughts and gestures, another five out that 93 had serious psychiatric side effects. Do you not think parents would be worried about that if their child were to be given this drug?

A. I believe that what parents would be more worried about is the risk that their children had of committing suicide and other symptoms of severe depression if no treatment was available. In my opinion parents want treatments to be properly evaluated during clinical trials before their children are given any medicine.


Q. But the evidence here suggests that their children might be at more risk of suicide if they go on Seroxat.

A. No, the evidence is not there. There is no statistical difference between the groups. The reality of the situation is that in this trial Seroxat was generally well tolerated by this difficult to treat population.


Q. You are not concerned about this and you do not think parents should be concerned about this?

A. What I am saying is that we are attempting to study Seroxat in this difficult to treat population. If, and when, we demonstrate the efficacy and the safety of the product, then the data will be submitted to the regulatory authorities with a view to getting a licence so that these patients and their doctors have another treatment available to them to treat this difficult disease.


Q. You would like it to be licensed for children?

A. Of course it must be driven by the data. There are many times we do clinical trials where you find that the balance of risk and benefit is not capable, in which case you do not try and get a license. The reality in this situation is the data we have generated so far is favourable. There is more benefit than risk in this population but until we have developed all the clinical trials, and done a full package of information, and adequately studied this drug in this population we cannot say that.


Q. Are you satisfied then that your company, generally, has done everything it can to keep patients properly informed about the negative side of the drug?

A. Absolutely, and it is not something we just sit and watch. Our summary of product characteristics is a living document. You start with a very limited number of healthy volunteers. Then you develop the clinical trials in thousands of patients. Then you make it available to tens of millions of patients around the world. As time moves on you collect more information and more data becomes available, and as a result we regularly change the information, which we provide to prescribers and patients for all our medicines, and of course for Seroxat as well. We will continue to do that. We will continue to monitor the safety of our medicines. We will make changes to the information to prescribers and patients, driven by facts and data not by anecdote.

Interview ends.



Less than one year after this interview a review of Seroxat data by the Committee on Safety of Medicines (CSM) showed that children taking tSeroxat may be more likely to self-harm or partake in suicidal behaviour. The Medicines and Healthcare products Regulatory Agency (MHRA) has also warned that adults who are on the drug should not suddenly stop taking it.

The review found that studies on more than 1,000 children also suggested those on Seroxat were at least twice as likely to have suicidal thoughts or self-harm compared to children with similar mental health problems who are not taking the drug.

Ironically, they only found this evidence after GlaxoSmithKline had sent in data because they wanted the MHRA to grant a licence for Seroxat to be used in children.

It was estimated that between the period of Alistair Benbow's interview with Shelley Jofre and the release of the news that Seroxat could cause suicide in kids, 8,000 patients under the age of 18 were treated with Seroxat in the UK.

In 2007, the BBC aired its fourth Panorama documentary regarding Seroxat.

On Monday January 29, 2007 Panorama showed shocking footage that demonstrated how GlaxoSmithKline's Public Relations people and marketing department 'spun' negative trial results on children which showed serious risk of suicide, self-harm and aggression.The trial also indicated Seroxat was no more effective than a sugar pill.

GlaxoSmithKline claimed to doctors that the drug was ‘remarkably' safe and effective for under-18s, with the support of an ‘independent' professor of psychiatry [Martin Keller] who earned $500,000 in fees from drug companies in one year.


Seven out of the 93 children in the Seroxat group had to be hospitalised for adverse reactions ranging from  self-harm, aggression, violence to others and suicidality (suicidal thoughts or actions, meaning actual suicide attempts)

In other words, almost 8% of children in the Seroxat group had the above adverse reactions.

What was it Benbow said in the interview?

"There is no statistical difference between the groups. The reality of the situation is that in this trial Seroxat was generally well tolerated by this difficult to treat population."

Was Benbow lying or was he not aware that data showed this significant [8%] figure?

In an internal company memo dated 14 October 1998, four years prior to Benbow's denial, GlaxoSmithKline executives concluded that Seroxat did not work and that a licence application would be refused: ‘The results of the study were disappointing. The possibility of obtaining a safety statement was considered, but rejected.' The best they felt they could achieve was a statement that 'although safety data was reassuring, efficacy had not been demonstrated'.

Did they go public with this?

Nope.

The self-harm, aggression and suicide attempts were kept quiet as was the lack of efficacy of Seroxat in children. PR people took over to implement a new plan: promote Seroxat to doctors as a treatment for under18's.

GSK's plan was simple and, it has to be said, unethical. They tried to persuade doctors that Seroxat was suitable for their child patients. From the 1998 internal memo showing that efficacy had not been demonstrated they spun the whole trial on its head with the clear message that Seroxat was ‘remarkably effective and safe for children'.

How did they do this?

KOL's - key opinion leaders in the field of child and adolescent psychiatry.

Martin Keller was, at the time, a renowned expert in the field of child and adolescent psychiatry. If Glaxo could get Keller to endorse the use of Seroxat in children then they were on to a winner.

Enter the ghostwriting machine.

Glaxo hired a PR firm to draft an article claiming Seroxat was beneficial for children. Keller put his name to the article which was later published in widely read journals. Job done, suicidal attempts, aggression and self harm were all hidden.

GlaxoSmithKline simply buried the data, including data from another, later trial on children which found that the placebos given to the control group of depressed kids ‘worked' better than Seroxat!

Glaxo later, forced by US medicines regulator the FDA to re-evaluate the raw data from Study 329, admitted to four further adverse reactions in which children became suicidal, raising the number suffering severe reactions to the drug from seven to 11 — a shocking 12 per cent of the total, and representing a 600% increase in events related to suicide.

Benbow knew nothing... apparently.



This half hour documentary goes into more detail about the whole sordid affair.




Bob Fiddaman




JOIN THE FIDDAMAN BLOG ON FACEBOOK



Please contact me if you would like a guest post considered for publication on my blog.