Monsanto Roundup Lawsuit

Friday, January 19, 2007

18 year old tells GSK like it is

I really feel for this poor soul. I have re-produced the letter to GSK in its entirety, purposely leaving in the grammatical errors as it truly shows the pain and suffering the poor individual went through.

The symptoms within their letter to GSK pretty much sum up how I felt. I too suffered from
Acid Reflux (still do) I wonder now if Seroxat caused this? Anyway, read on:

The truth about Paxil
by Stephen E. written to GlaxoSmithKline plcPosted Wed June 26, 2002

Drugs have become a booming business today, and your products are very important -- critical even -- to many millions of people. I'm on one of them, and that's why I feel compelled to send you this complaint about effectiveness at your company. Specifically, my complaint is about Paxil. I am really furious about this.

First I want to start off by saying what a horrible company you are and that I am currently talking to a lawyer about joining the many current lawsuits against you people. I started taking paxil when I was 16, soon after losing all inhibitions for life and followed by several suicice attempts and panic attacks, as well as many side effects that I had no idea could be related to paxil. Now after 2 years and one try to try and quit going through horrible withdrawl effects that YOU KNEW ABOUT and didn't tell me or my doctor I now know that these side effects are caused by YOUR product, these side effects iv had for over a year now but never thought it had anything to do with paxil because YOU PEOPLE didn't warn me of: (I also am developing a muscle spasm disorder only after 7 days of wheening off of your product in a 10 mg drop.) And by the way, don't bother asking for a release to see my medical information, because you won't get it. You deserve to pay me and thousands of other people for the pain that you have caused.

My Depression and anxiety sympoms worsed. I never had depression before I started on the meds, and my anxiety actually got worse in some cases. -Panic attacks, I never had a panic attack before on paxil, and experienced them more times then I wanted to after starting on your mind altering poison.-Hot surges running through my body with proufous sweating. -Horrible nightmares or aggressive dreams, dreams of having battles with people from past. Alot of the time I have trouble remembering if something happened in a dream or in real life.. -Obsessive thoughts.-I got these before on the medicine so it is hard to say that paxil is to blame. Though in alot of aspects it has gotten worse, or stayed the same, and isn't paxil supposed to make it go away?

-Just can't seem to feel any more. Just don't care anymore. Feelings of "who cares" and "fuck it"-Perhaps the most common side effect that YOU don't warn us about, the most common one I've ever seen in my research. This happened almost immidiatly after starting the drug, only caring about a video game, not caring if I showered or brushed teeth, not caring if I had a job or went to school, I found myself knowing I would grow up to be a homless loser when I grew up and I didn't care.I didn't care that we were broke and we might now lose the house because of me and my mom has to now work 2 jobs as a single parent to two.

Feeling like a zombie. No emotions. Unable to feel "normal" sadness or cry at all. Excessive or "fake" happiness.-This is also another common side effect YOU don't want people to know. The fact that these drugs are just a "band-aid" of sorts, it made me unable to feel sadness and happiness. This wasn't constant, because at alot of points during the years I would be able to feel sadness, and it was horrible, much worse then sadness I had before I was on the drug. The only thing I couldn't experience was happiness, I had the fake happiness alot, like something good happening in the game I would be extactic, but if something bad happened in the game I would think of suicide, I would begin to cry over anything ect ect.

Severe dizzyness, fear of passing out or losing control.- Alot of the time I would have to hold on to the walls when going to the bathroom or down the stairs to stop myself from falling downstairs. -

Sleeping with lights on because of the fear-this happened alot earlier, I would keep the TV on with no sound just for the light, I never knew why.

-Feeling disconnected,foggy, feeling of unreality or drugged out-This is a big one, which hurts my concentration, which is another side effect i list later.

-Heart palpitations-i get this quite often

-Tightness in the head-i get this alot, also the back of my head gets numb.

-No personal identity/opinions of your own.-This is constant, I never have any opinions of my own and constantly feel like I don't have my own personality.

-Feelings of being unnable to function like a normal human being.-these thoughts have plagued me for years.

-Hate to go out or be around people. Also may hate people, not even comfortable with familiy-this was the problem that got me onto the paxil, though its hard to say if it got worse, I know it hasn't gotten better.

-Feeling like it will never end.-again these feelings have haunted me since I started on these drugs.

-Urge to jump from a moving car.-maybe a few times, it is hard to remember

-Extreme head pain-maybe once or twice a week I will get horrible headaches, I've tried taking asprin etc but nothing works.-I'm not sure I will ever be my old self again or be normal again.-I'm Convinced of having some rare and fatal disease constantly. I have been in and out of hospitals for over a year, thinking I have a heart problem, gunna have a heart attack, thinking I have a tumor, as soon as something went wrong, weather a sour throat to a pain in my toe I thought I was going to die of some rare and fatal disease.

-Fatigue and problem in hands(predominantly left) tingling, mild to severe tremors, more pain and slight stiffness may spread up arm into sholder.-i get this alot, mostly just tinglings and tremors, sometimes pain would move up to my sholder and I would panic thinking I would have a heart attack. This happens 4-8 times daily.

-Heavy bleeding from the nose.-there was a time were I had nose bleeds,(where i was convinced of having some rare disease) it went away in a few weeks.

-Nausia, gastrointestinal problems, feeling bloated and full.

Acid reflux disease, severe flatulance.-I have acid reflux disease, and even though I've tried every drug to treat it, it hasn't gotten any better, I still feel nausiated for a few hours after I eat, as well as severe flatulance, if i were to count, i would guess that I burp at least 2,000 times a day and fart at least 1,000.(keep in mind these are 24-48 hour days) My doctor is stumbled on how I could have gotten Acid Reflux Disease

-Memory loss with apathy, trouble concentrating. Trouble focusing, hard to read words.I have very bad memory, often I'll stop in the middle of the sentance searching for a word to say. I don't concentrate, days that I have gone to school when I'm off of paxil I wouldn't be able to concentrate or focus. Before on these drugs I passed all my classes as well as wrote a novel(I like to write, I used to write alot before I was on the drugs, whereas I just didn't want to write it, and now its at the point where I can't even remember most of the ideas I had for stories.). Also I can watch a movie, and then the next week wonder if I saw it, and tell my mom that I want to go see this movie and she complains that I just saw it.

-Manic/depressive episodes-this happened alot, specially if something bad happened in the game, like I died or lost an important item ect.

-Chills-This happens to me at least 4 times a day, even in the heat my entire body will just shake in one fast jerking motion from the top to the bottom, it only lasts maybe a second or two.

-Head jerking and muscle spasms. REM(rapid eye movement) that leads to insomnia, Tremors, sudden jerky movements of muscles. -I've had these for alittle over a year now. Mostly my legs and arms will jerk suddenly without me wanting them to, it happens more at night. Rapid eye movement keeps me up at night, and I'm up basically till I'm so tired that I just pass out because of REM in conjunction with nausia and constantly having to sit up and burp because of the acid reflux disease -Feelings of hopelessness and feelings that you are out of control.-I have feelings of hopelessness alot, like the only way to get out of it is suicide etc.

-Suicidal-perhaps the most dangerous side effect hidden from our eyes, I have read dozens of stories of suicide because of paxil. I especially found the 8 million dollar reward to the family of the man who shot his wife daughter grandaughter and himself quite interesting. At the drop of a hat I could become suicidal, even if the littlest thing went wrong I thought of it, even though I'm horrified of dieing, and constantly thinking i have some fatal disease. -Inner restlessness, feeling that something is not right but I am not sure what, but it is there haunting me in the back of my brain.and its there all the time, and it drives me crazy, it is hard to explain but best described as Morphius said in the movie the matrix "You don't know what it is but its there, like a blister on your brain, haunting you."

-Worsening or delayed cure of acne.I started getting acne after i started on these damn drugs, since then I've tried everything to get rid of it, and currently on two prescriptions from a dermatoligist.

-Severe hot flashes while asleep, wake up covered in sweat every night

-Severe mood changes. Anger and violent one second, then happy, then very very sad. Very rude and short tempered all the time. At first I hadn't noticed it but my mom often complains about how rude i am, and I am very short tempered about things, fighting with my mother or brother I'll flip out and start screaming and cursing for little arguments.

-Heavy Sweating all the time. -Urge to drink excessively, sever dry mouth.This is constant, I can not leave my house without a water bottle, and if i do my mouth gets very very dry and I start to panic thinking I'm goign to vomit, never happened before I were on these drugs. -Feet stay cold, can never seem to get them warm at all, cept right after I get out of a hot shower. -Need for increased dose for same symtom, tolerance. I started with 10, then 20, then 30, then 40, then doctor wanted me to go to 60. I originally was till I found all the research proving your drug to cause all these problems.

-Sleepy all of the time, but cannot fall asleep, Insomnia caused by REM. When i do fall asleep I sleep ALOT 13+ hours a night. Like I said before about my insomnia, but when I do sleep I sleep for 13+ hours, even if I was awake for a normal 10-12 hours, when I first started and before I got the REM I was awake for 12 hours, then slept the other 12 which led to halting of going to school.-Visual and Audio Hallucinations.If i look at my wall for awhile I can see paterns, or people moiving around, once at a friends house I was looking at his curtains in the dark and saw spiderman swinging from buildings. Audio wise I hear ringing all the time, as well as humming or buzzing, sometimes doorbells and phones ringing.

-Breathing problems. Feelings like I am going to stop breathing, tightness of chest, feeling that something is wrong with my breathing.This happens all the time, and is happening as I'm typing right now, usually its tightening in my chest or feeling like my throat is closing.

-Muscle and joint pains. -Itchy, rashes on legs, knees, under arms and back. This isn't constant but many times during the day I find myself unable to stop scratching these parts of the body. -Pain in the lower left hand side of the stomach which mild to very often, usually its just nauisa tho. -Self mutilation,cutting myself.

-Changing myy mind every minute, decide to do one thing, then decide to do another, decide that a spoon is clean, then decide its dirty and get a new one-Lethargic, very weak, ,no energy to do anything, lost all inhibitions to do anything.

-Mild to Severe constipation on and off, coupled with diareah the times that I've tried to get off of your death pill.

I'd like to direct you to where they have publiciced medical journals about the effects of paxil that YOU do not warn us about, especially including withdrawl and side effects. Now I don't believe in god or anything but I believe you people are sick. You should be taking these pills and see how you like it. I know people will do anything for money but this is just too much, your hurting hundreds of thousands of people for life, and like i said before, don't even think about asking me for medical release because you will not get it. You are a lieing manipulating evil company and I and many other people won't rest until the world knows about these horrible things that you don't want the world to know

Frankly, I guess I'm not surprised by this latest problem because I've been very dissatisfied in the past. I definitely won't be a repeat customer of yours, and I definitely won't recommend you to people I know.

Here's what I think GlaxoSmithKline plc should do: take paxil OFF the market andpay the people you hurt money for thier pain and what it has done to thier lives!.

I hope to get a response from you soon. This is a very important matter, not just for me but for all consumers of your products.

Thursday, January 11, 2007


Mr GlaxoSmithKline (12.08.03)

Poor old Mr Sneeze. Not only is he forever battling his year-round sniffles in Coldland, he's now under investigation by a Government Watchdog who want to scrutinise his association with multinational pharmaceutical firm GlaxoSmithKline.

The rumpus centres on a recent promotional Mr Men book written and illustrated by Adam Hargreaves and titled 'Mr Sneeze And His Allergies'. According to The BBC it was funded by GSK and shows us how, with some help from Little Miss Sunshine, Mr Sneeze is urged to take action against a suspected dose of hayfever. But alas, their good work is undone by the arrival of Mr Silly and his pet chicken, called Rover (!).

After the story there are four pages of allergy information from Allergy UK and - this is the problem area - two pages promoting the use of GSK products.

50,000 copies of the book have been printed so far this year and distributed to Tesco Clubcard holders, allergy road shows, allergy clinics and doctors surgeries. The book was approved by The Proprietary Association of Great Britain, which is responsible for checking marketing material from pharmaceutical companies. And what's more, they're standing by their decision to back the project, citing its confident public health message.

But the Medicines and Healthcare Products Regulatory Agency aren't so convinced, because The Medicines Act of 1994 prohibits the promotion of medicines to children. Of course, GSK rebuke such allegations...

This one might want to run, and run. But really, we hope it doesn't!

Wednesday, January 10, 2007

GSK help heal the 'well'

Not content with supplying Paxil/Seroxat to patients with what they deem as a low level of serotonin in the brain, it seems Glaxo SmithKline are now targeting people who only think they have an illness...hypochondriacs!

The following article is from the Washington Post.

Take particular care and attention when reading the final paragraph


Drug May Help Hypochondriacs


And now, a real pill for your unreal illness.

Scientists report that the antidepressant Paxil helped hypochondriacs be less fearful about getting sick. In the first controlled study that compared a group of hypochondriacs given the drug with a group that got psychological talk therapy and another group that received sugar pills, the medication significantly reduced people's fears about imaginary illnesses.

Before the trial, one 40-year-old, who said he had fears starting at age 10 that he was going to die in his sleep, rated his certainty that he was suffering from a serious illness as an 8 on a scale of 1 to 10. After six weeks on Paxil, his fear level dropped to a 4 -- an improvement that led him to continue the medication after the trial.

According to the standard manual of mental disorders, hypochondriasis is a potentially serious condition that can prompt people to go doctor shopping, abuse sick time at work and become complete invalids.

The study found that hypochondriacs who got cognitive behavior therapy, which encourages people to challenge the validity of their disabling beliefs, also improved -- as much as those given the drug. Researchers suggested that a combination of this talk therapy and medication might be especially effective.

The study was published this month in the American Journal of Psychiatry by researchers at Leiden University in the Netherlands and other Dutch centers. It was funded by an "educational grant" from Glaxo SmithKline, which makes Paxil.

Shankar Vedantam

Now here's my slant on this:

If Paxil/Seroxat is to be prescribed to hypochondriacs then Glaxo SmithKline and the Medicines Healthcare and products Regulatory Agency can pass their withdrawl symptoms off as nothing more than hyphchondriasis. Their addiction will no doubt also be passed off as a psychological problem.

Let's just look at this segment from the above article shall we?

"... After six weeks on Paxil, his fear level dropped to a 4-- an improvement that led him to continue the medication after the trial."

Well done GSK - Another group of people to target your drug at.

How can a GP diagnose a hypochondriac who walks into his/her surgery complaining of withdrawal symptoms... or worse still that the hypochondriac wants to kill themselves? I find this latest trial sickening and nothing more than a money making project for GSK.



The FDA are the equivalent of the UK's MHRA


Paroxetine withdrawal syndrome can last one heck of a
lot longer than 3 months. I have it for more than 2 years; I was
unable to work for 6 months because of it. It's only been in the last
6 months that I've been able to function at all normally, and I still
have relapses.

Here's a little essay I wrote about the monoamine theory of
depression on, an online support group for people
with paroxetine withdrawal syndrome:

It is true that manipulating the serotonin receptors (and other
neurohormone receptors) appears to relieve the symptoms of depression
and some other psychiatric disorders. However, that is not proof that
a deficiency of serotonin or any other neurohormone is the cause of

What it demonstrates is that if you alter the neurohormone balance
and, doing that, the interaction of hormones throughout the body, it
can have positive mood effects. In a minority of people, altering the
hormonal balance has adverse effects, sometimes fatal, as they become
suicidal or homicidal.

The mechanism controlling mood can be anywhere in the body's hormonal
system. Sometimes it's the thyroid. Sometimes it seems to be
metabolic, based on a lack of omega-3 fatty acids, essential
minerals, vitamin B12, or other nutrient. Sometimes it is in the HPA
axis, such as noradrenergic hypersensitivity.

The statistics are further contaminated because quite often
antidepressants are prescribed on the basis of misdiagnosis. A third
of all untreated cases of "depression" resolve spontaneously because
the condition was situational or, who knows, a transient hormonal
imbalance. This means that antidepressants often are credited with
successful treatment when the patient would have recovered anyway
without medication.

In general, medicine operates on the assumption that the widespread
hormonal disruption caused by antidepressants, on balance, is
beneficial. Danger signs such as weight gain, hypoglycemia, and
adverse effects on sexual response (this last affecting approximately
50 percent of patients) are ignored.

Those of us who are suffering severe discontinuation syndrome are the
canaries in the coal mine. Our problems reveal that the hormonal
disruption may not be benign. Whether occurring during treatment with
antidepressants or in withdrawal, it is certainly vastly underreported

The calculations that net out a benefit for antidepressant use may be
highly distorted, by accident and by design -- there is vast profit
in the defense that, overall, side effects are minor.

And patients should be made aware of the risks so they can make
informed choices.



Tuesday, January 09, 2007



The patient information leaflet that comes with Seroxat claims that...

"...People who are depressed or anxious have lower levels of serotonin than others."

There is plenty of information on this blog that suggests otherwise.

Here is an email I recieved today.

----- Original Message -----
From: Dan Adams
Sent: Tuesday, January 09, 2007 8:04 PM
Subject: RE: Serotonin
Dear Mr. Fiddaman,

Currently, as far as I understand, there is no way to determine proper serotonin levels in the brain. One major problem is that cerebral serotonin levels are difficult to measure (brain barrier issues). Another problem is determining whether the serotonin is interacting the way it should. This is why treating depression and serotonin deficiency is largely a guessing game. Doctors prescribe selective serotonin reuptake inhibitors in an effort to keep serotonin in the system longer, but they have to do it in increasing doses until the patient either responds well or has an overdose reaction. Typically, doctors try a number of combinations until something works (I’m sure you already understand this.)

However, some progress is being made, particularly with serotonin tracers, molecular compounds which bind with serotonin and can be traced in the brain. These compounds are radioactive and can be measured in an fMRI or PET scan. We have some friends at the University of Liege, in Belgium, who are pioneers in this area and are very close to developing a traceable serotonin marker in humans. Perhaps within a few years, we’ll have better answers as to how serotonin works in the brain, and how to measure the proper amount/balance.

In the meantime, I’m sure you recognise the importance of light therapy and receiving light in general. Light does what SSRIs cannot; light produces serotonin in the brain, while SSRI’s work to keep serotonin from being absorbed too quickly. This is why several studies have shown that a combination of light and medicine are synergistic, that is they work better than either alone. These studies have been done on seasonal and non seasonal major depression.

A good site to review is: Also, I would be a bit concerned that the over use of light therapy and or the overuse of the combination of both light and medication can lead to an ‘over reaction’. If one feels jittery, nausea, anxiety or mania, one should discontinue the use of light for a few days and then very gradually increase the amount again.

Good luck,

Dan Adams
Research Dir
Apollo Health

People who are depressed or anxious have lower levels of serotonin than others.


Fellow Seroxat sufferer sums the whole issue of the corrupt activities between Glaxo SmithKline and the MHRA with a brilliant article here:

Take a bow.


Academic thesis on Serotonin

Here is an academic thesis on Serotonin, attempting to ascertain which biological theory of depression is most strongly supported by the available evidence.

‘The Emperors New Drugs’ journal article pretty much substansiates what this scholar wrote over three years ago!

It has been suggested that depression results from the depletion of certain brain neurotransmitters such as Norepinephrine for example, Richelson (1991). However biochemical theories of depression fail to account for environmental causes of depression which undoubtedly cause the illness in the majority of cases, the past experiences of the individual leading to lowered amounts of neurotransmitter and it can therefore be argued resulting in depression as a consequence perhaps as an evolutionary adaptation, Nesse (2000). Farvolden, Kennedy, & Lam (2003) suggest that effective treatments include the existing range of therapeutic drugs: SSRI (Selective Serotonin Reuptake Inhibitors), SNRI (Selective Norepinephrine Reuptake Inhibitors), MAOI’s (Monoamine Oxidase Inhibitors) and Tricyclic antidepressants. However there is significant evidence to suggest that such drugs rather than resulting in remission merely treat the symptoms rather than the cause, Farvolden et al (2003).

Indeed it has even be suggested that the aforementioned antidepressants are little better than placebos, any pill whether containing an inert substance such as talc or the active drug Paroxetine (Seroxat) one of the SSRI class of medications having pretty much the same therapeutic effect perhaps as a result of a release of neurotransmitters instituted by the brain in response to placebo, Kirsch, Moore, Scoboria, and Nicholls (2002).

To determine which biochemical theory of depression is most strongly supported by the available evidence the remainder of this essay will look at the current evidence, evaluating and interpreting the suggested causes of depression leading to a valid conclusion.

Before looking at the biochemical theories of depression it is important to look briefly at things that are known to cause depression in the first instance such as childhood anxiety disorders, Muris, Meesters, & Van Melick (2002). Muris et al (2002) carried out a study with children aged 9-12 years to compare the effectiveness of cognitive behavioural therapy with a psychological placebo such as emotional disclosure. Participants in the study were either assigned to cognitive behavioural therapy (a), emotional disclosure (placebo) (b), or (c) no treatment (control). The results of the study indicated that cognitive behavioural therapy (CBT) was superior to emotional disclosure, and the no treatment conditions. The researchers concluded from the results that only the CBT condition resulted in significant reductions in anxiety, trait anxiety and depression. It can easily be argued from the results of the Muris et al (2002) study that the cognitive behavioural therapy method of treatment caused a remission of psychiatric symptoms of the young participants in the study. However what is unclear is exactly what the method achieved, i.e. was it an increase in neurotransmitters or something else entirely?

Healy (2002) highlights that there exist two separate biochemical theories of endogenous depression: the amine, and catecholamine theories. Schildkraut (1965) proposed in the catecholamine hypothesis that depression resulted from a decrease in available Norepinephrine at central adrenergic receptor sites, Norepinephrine inhibitors such as Reserpine resulting in depression, and MAOI’s increasing levels of Norepinephrine, relieving depressive symptoms. Whereas in the Indoleamine hypothesis there exists evidence to suggest that there is an imbalance or disturbance in three main areas;
Amine metabolism, electrolyte distribution and, or hormonal function result in depression and other affective disorders, Toru, & Itokawa (2001).

There is a problem with the catecholamine hypothesis however. If depression resulted simply as a result of lowered catecholamine levels within the brain one would expect that alpha-methyl-paratyrosine would cause depression in humans as it inhibits the enzyme tyrosine hydroxylase limiting catecholamine synthesis, and the introduction of the chemical does not have that effect, Berman, Sanacora, Anand, Roach, Fasula, Finkelstein, Wachen, Oren, Heninger, and Charney (2002). Berman et al (2002) carried out a study to assess the integrated role of the monoamine system in depressed patients. It was decided that un-medicated depressed subjects would be asked to partake in a 2 week double blind, random ordered crossover study. Subjects were placed in active indoleamine (via tryptophan depletion the precursor of Serotonin) plus catecholamine (via alpha-methyl-paratyrosine administration) depletion and separately Indoleamine plus sham (via diphenhydramine administration) catecholamine depletion.

The results of the Berman et al (2002) study suggests that simultaneous disruptions of the indoleamine and catecholamine systems do not make depression worse in previously un-medicated subjects. This finding lends support to the theory that monoamines regulate mood by some as yet unknown indirect mechanism such as the suggestion that neurotransmitters interact with one another, and that imbalances of these neurotransmitter systems result in depression. The currently held hypothesis is that monoamine depletion results in depression, Leonard (2000). Leonard suggests that the monoamine hypothesis predicts that there is some form of impairment of the monoaminergic system with lower than normal levels of Norepinephrine, Serotonin or both. Depletion studies have indicated a correlation between such deficiencies and depression, researchers measuring the active neurotransmitters and their metabolites in cerebrospinal fluid and urine, Sobczak, Honig, Van Duinen, Riedel, (2002). This would suggest that no one neurotransmitter is implicated in isolation and that instead of proposing that there is an abnormality in a singular neurotransmitter system perhaps more than one of the neurotransmitters interacting together results in depression. There have been several attempts to propose such a biogenic hypothesis, Prange, Wilson, Lynn, Alltop, & Stikeleather (1974). Researchers have found that drugs that act by increasing the amount of neurotransmitter in the synaptic cleft take a number of weeks to take effect, and can in some cases result in increasingly severe depression and anxiety in the mean time before the drug becomes effective, Bourin, David, Jolliet, & Gardier (2002).

During Paroxetine withdrawal, patients are known to experience very severe symptoms including electric shock like sensations, mood instability, hypomania, suicide, paresthesia’s etc., Haddad, Devarajan, & Dursun (2001), again suggestive that a reduction in Paroxetine (Seroxat) results in not only a lowering of Serotonin but perhaps also in Dopamine causing coordination problems similar to those found in Parkinson’s disease. Haddad et al (2001) highlight that 2 patients presented with stroke like symptoms which were later attributed to withdrawal from Paroxetine. The manufacturer GlaxoSmithKline have recently been found guilty of homicide where a grandfather murdered his wife, daughter and baby granddaughter before committing suicide after only two days on Paxil (Seroxat) resulting in law suits in several countries including the United States and United Kingdom, patients claiming that the drug is addictive and causes a range of very unpleasant side effects and withdrawal symptoms including those already mentioned, Boseley (2001).

Since SSRI and SNRI medications do not elicit immediate improvements in depression despite evidence that such drugs stop Serotonin or Norepinephrine from being reabsorbed in the synaptic cleft almost immediately, resulting in more of the neurotransmitter becoming available. This would suggest that indeed neurotransmitters do interact with one another, the increase in Serotonin leading to increases or decreases in other neurotransmitters, and thus reductions in symptoms of depression. The antidepressant medication Venlafaxine has a clinical effect upon both Serotonin and Norepinephrine and has been shown to elicit a much quicker response rate in terms of action again supporting the notion that several neurotransmitters are implicated and perhaps interacting together, Artigas, Nutt, & Shelton (2002). There is some evidence to suggest that SSRI medications such as Prozac and Paroxetine for example result in emotional blunting, Opbroek, Delgado, Laukes, McGahuey, Katsanis, Moreno, & Manber, (2002). It can be argued therefore that this could lead to the individual prescribed such drugs losing interest and pleasure in pursuits that they previously found enjoyable for example sex. SSRI’s often result in loss of libido, Hsu, & Shen (1995).

It can be hypothesised that Paroxetine and other SSRI medications increase Serotonin but also interfere with the Dopamine system since it has been demonstrated that the neurotransmitter Dopamine is involved in sexual function, Giuliano, & Allard (2001), and pleasure, Davis, & Woodside (2002). Therefore based on this argument it is easy to see how a grandfather might murder his entire family before turning the gun upon him-self after a very short period of time taking an SSRI ‘supposed’ to treat depression, his emotions blunted by Paroxetine to such an extent that he no longer found any pleasure in life.

This hypothesis is consistent with there being an interaction between the neurotransmitters Serotonin, Norepinephrine, Dopamine and depressive illnesses.

As has been mentioned previously Kirsch, Moore, Scoboria, and Nicholls (2002) analysed the efficacy data submitted to the Food and Drugs Administration (FDA) for approval of the 6 most widely prescribed antidepressants: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Venlafaxine (Effexor), Nefazodone (Serzone), and Citalopram (Celexa) between the years 1987 and 1999 respectively. The results of the study indicated that 80% of participant responses to the medications were as a result of a placebo effect. Based on this finding it can be argued that antidepressant medications are little more than expensive placebos that cause severe side effects and withdrawal symptoms. Indeed Kirsch et al (2002) discuss in detail that researchers and participants alike knew without a doubt when the active drug was being given because placebos do not produce such side effects since they are inert substances used as a control to highlight that it was the drug having the clinical effect rather than a non-drug.

Healy (2002) suggests that psychotropic drugs were placebo controlled from the 1960s to 1984, but that the majority of trials following this period were merely a comparison between old and new medications, and therefore it is impossible to determine whether or not such ‘new’ dugs are actually better, or indeed if they even have any clinical efficacy. This has allowed pharmaceutical companies to state that their products are superior ‘magic bullets’ that are effective over a range of psychiatric illnesses where Serotonin has been implicated such as social anxiety disorder and obsessive compulsive disorder, based on dubious clinical trials that indicate only modest effectiveness, Healy (2002).

Healy purports that, “The clinical trial results are not compatible with the idea of a Serotonin lesion or a magic bullet effect in any of these disorders.”

It can be suggested that pharmaceutical companies such as the aforementioned GlaxoSmithKline have purposefully kept clinical trial data confidential because the data from such studies doesn’t back up their claim that the drugs are as effective in the treatment of depression or any of the other disorders for which they have gained a license to treat. The Government licensing body, the Medicines Control Agency and their expert advisors the Committee on Safety of Medicines have shares and other financial interests in both the drugs and companies they license drugs on behalf of. Therefore it can be argued that Seroxat (Paroxetine) and other SSRI’s gained a license not because they were effective, but rather because members sitting on the licensing committee had a conflict of interest, and still do, Committee on Safety of Medicines (1999). This view is supported by a recent Guardian newspaper article where an expert review was invalidated by the Committee on Safety of Medicines members having undisclosed interests in the SSRI’s they were supposed to be conducting a safety review of, Boseley (2003).

Based on the available evidence it is clear that the neurotransmitters Serotonin, Norepinephrine and Dopamine are all implicated in depression supporting the Indoleamine theory of depression. It is far from clear however whether or not the current range of new antidepressants, i.e. the SSRI and SNRI class of medications have any conclusive evidence to support the view that they benefit patients to the levels purported by pharmaceutical companies.

Any effect during clinical trials could it can be argued be a result of a placebo effect, participants perhaps believing that because they are experiencing side effects that this will lead to remission or partial remission of their depressed condition the levels of neurotransmitters in turn increasing or normalising due to the placebo effect. The fact that SSRI and SNRI medications take a number of weeks to elicit any antidepressant effect despite evidence to suggest that they act almost immediately also supports the view that decreased levels of a specific neurotransmitter is not the cause of depression but rather merely one of the causes. The study conducted by Berman et al (2002) where catecholamines were ruled out as the cause of depression supports the hypothesis that Amines, and perhaps hormonal imbalances result in depression and disorders where Serotonin and Norepinephrine have been implicated, Healy (2002).

Further research is necessary to determine whether or not the current ‘wonder drugs’ such as Seroxat and Prozac are as effective at treating depression as their manufacturers claim, and perhaps more importantly to dispel patient anxiety as to whether or not the SSRI class, Paroxetine (Seroxat) in particular are drugs of dependence, and can cause serious adverse reactions including suicide. Another important suggestion might be for the Government to tighten the rules governing who can and cannot sit on drug licensing bodies, as it is clear that many of the current members of the Committee on Safety of Medicines have intolerable conflicts of interest and it can be argued licensed unsafe drugs for the treatment of depression during the late 1980s and early 1990s resulting in it can be argued innumerable deaths as a result of suicide and withdrawal symptoms caused by adverse reactions to the medications.


Artigas, F., Nutt, D. J., Shelton, R. (2002). Mechanism of action of antidepressants. Psychopharmacological Bulletin, 36, 2: 123-132. Abstract from Endnote, Pubmed.

Berman, R. M., Sanacora, G., Anand, A., Roach, L. M., Fasula, M. K., Finkelstein, C. O., Wachen, R. M., Oren, D. A., Heninger, G. R., & Charney, D. S. (2002). Monoamine depletion in un-medicated depressed subjects. Journal of Biological Psychiatry, 51, 6: 469-473.

Boseley, S. (2001). Four People Dead is Four too Many. Guardian Unlimited. Online Resource:,3605,534058,00.html

Boseley, S. (2003). Drug review halted over company links. Guardian Unlimited. Online Resource:,3604,921855,00.html

Bourin, M., David, D. J., Jolliet, P., & Gardier, A. (2002). Mechanism of action of antidepressants and therapeutic perspectives. Therapie, 57, 4: 385 - 396. Abstract from Endnote, Pubmed.

Committee on Safety of Medicines, (1999). Market Towers, London. Online Resource:

Davis, C., & Woodside, D. B. (2002). Sensitivity to the rewarding effects of food and exercise in the eating disorders. Journal of Comparative Psychiatry, 43, 3: 189-194. Abstract from Endnote, Pubmed

Farvolden, P., Kennedy, S. H., & Lam, R. W. (2003). Recent developments in the psychobiology and pharmacotherapy of depression: optimising existing treatments and novel approaches for the future. Expert Opinion Investigating Drugs, 12, 1: 65 – 86. Abstract from Endnote, Pubmed.

Giuliano, F., Allard, J. (2001). Dopamine and sexual function. International Journal of Impotence Research, 13, 3: 18-28. Abstract from Endnote, Pubmed.

Haddad, P. M., Devarajan, S., & Dursun, S. M. (2001). Antidepressant discontinuation (withdrawal) symptoms presenting as 'stroke'. Journal of Psychopharmacology, 15, 2: 139-142. Abstract from Endnote, Pubmed.

Healy, D. (2002). The Creation of Psychopharmacology. Harvard University Press, pp, 114, 143, 209, 290, 299, 307.

Hsu, J. H., & Shen, W. W. (1995). Male sexual side effects associated with antidepressants: a descriptive clinical study of 32 patients. International Journal of Psychiatry Medicine, 25, 2: 191 – 201.

Kirsch, I., Moore, T. J., Scoboria, A. & Nicholls, S. S. (2002). The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration. Prevention & Treatment, Volume 5, Article 23. Online Resource:

Leonard, B. E. (2000). Evidence for a biochemical lesion in depression. Journal of Clinical Psychiatry, 61, 6: 12-7. Abstract from Endnote, Pubmed.

Muris, P., Meesters, C., & Van Melick, M. (2002). Treatment of childhood anxiety disorders: a preliminary comparison between cognitive-behavioral group therapy and a psychological placebo intervention. Journal of Behavioural Therapy Experimental Psychiatry, 33, 3-4: 143-158. Abstract from Endnote, Pubmed.

Nesse, R. M. (2000). Is depression an adaptation? Archive of Gen Psychiatry, 57, 1: 14 – 20. Abstract from Endnote, Pubmed.

Opbroek, A., Delgado, P. L., Laukes, C., McGahuey, C., Katsanis, J., Moreno, F. A., Manber, R. (2002). Emotional blunting associated with SSRI-induced sexual dysfunction. Do SSRI’s inhibit emotional responses? International Journal of Psychopharmacology, 5, 2: 147-151. Abstract from Endnote, Pubmed.

Prange, A.J, Wilson, I.C, Lynn, C.W, Alltop, L.B, Stikeleather, R.A. (1974). L-tryptophan in mania: contribution to a permissive hypothesis of affective disorders. Archives of General Psychiatry, 30: 56–62. Abstract from Endnote, Pubmed.

Richelson, E. (1991). Biological basis of depression and therapeutic relevance. Journal of Clinical Psychiatry, 52: 4 – 10. Abstract from Endnote, Pubmed

Schildkraut, J. J. (1965). The catecholamine hypothesis of affective disorders: a review of supporting evidence. American Journal of Psychiatry, 122, 5: 509-522. Abstract from Endnote, Pubmed.

Sobczak, S., Honig, A., Van Duinen, M. A. Riedel, W. J. (2002). Serotonergic dysregulation in bipolar disorders: a literature review of serotonergic challenge studies. Journal of Bipolar Disorder, 4, 6: 347-356. Abstract from Endnote, Pubmed.

Toru, M, & Itokawa, M. (2001). A history of famous hypotheses and the future development of studies on affective disorders. Nippon Rinsho, 59, 8: 1437-1443. Abstract from Endnote, Pubmed.

Saturday, January 06, 2007






Not only do Pharmaceutical companies settle out of court, they also place gagging orders on websites whom wish to report on the said settlements.

To put this in laymans terms:

Evidnce comes to light in a trial that a specific drug can cause diabetes. The pharmaceutical company, knowing they have been backed into a corner and have little chance of winning the case, decide to settle out of court. A large sum of money is offered on the proviso that the plaintiff/s 'keep quiet'.

Normally the Pharmaceutical company will state in a press conference any of the following:

X denies the lawsuits claims


X wants to resolve the matter to avoid further litigation costs

Because of the 'settlement', any evidence heard in the trial is usually supressed.

We saw Pete Breggin's damning report on GSK earlier this year, a report that was originally sealed... now we have yet another Pharmaceutical company wishing for gagging orders to be placed on not only the plaintiffs but independent reporters/Websites/Blogs too.

Wanna see?


Two must see blogs

Moral excellence comes about as a result of habit. We become just by doing just acts, temperate by doing temperate acts, brave by doing brave acts.



It is easier to decipher the following than it is to decipher communications from the MHRA!

Friday, January 05, 2007

Paxil’s Ghost - More GSK corruption!

Paxil’s Ghost


When the FDA’s Psychopharmacologic Drugs Advisory Committee holds its public hearing on December 13 to consider yet again the possible links between suicidality and the SSRI/SNRI antidepressants, one distinguished member of the advisory committee will be Dr. Bruce Pollock. Pollock used to be on the faculty at the University of Pittsburgh, but last year he was appointed to the Sandra A. Rotman Chair in Neuropsychiatry and Head of the Division of Geriatric Psychiatry at the University of Toronto. Pollock is also one of three committee members with extensive financial ties to antidepressant manufacturers. Pollock will not be allowed to vote, but his expertise was deemed so important by the FDA that his conflicts of interests were waived so that he could be included on the committee.

Pollock’s name may be familiar to scandal watchers. Two years ago, Congress was holding hearings on the question of whether GlaxoSmithKline had suppressed studies unfavorable to Paxil, and the New York attorney general had charged GlaxoSmithKline with consumer fraud. (GlaxoSmithKline settled the lawsuit without admitting wrongdoing, but paid a $2.5 million fine.) In December 2004, ABC News aired an investigative report on GlaxoSmithKline titled “Drug Maker Withheld Paxil Study Data: ABC News Uncovers Documents Unknown to Regulators and Many Study Doctors.” One of those documents concerned Pollock’s work for GlaxoSmithKline.

In the late 1990s, worries had emerged that patients might become dependent on the SSRIs. To combat the perception that people who stopped using Paxil might experience withdrawal symptoms – or “discontinuation” symptoms, as they were often called – GlaxoSmithKline (then still known as SmithKline Beecham) hired a public relations agency called Ruder Finn. Ruder Finn drafted letters that they planned to submit to scientific journals and that downplayed the idea that Paxil was associated with discontinuation symptoms. According to internal memos, Pollock was one of four psychiatrists whom they planned to invite to “author” the letters.

A letter from Pollock eventually appeared in the Journal of Clinical Psychiatry. Although the wording of Pollock’s letter was somewhat different from the draft written by Ruder Finn, it made all the same points. It even made them in the same order. But there was no disclosure, no mention of industry funding, no mention of “editorial assistance,” and no mention of Ruder Finn. Pollock concluded his letter by saying, “Rather than directing our efforts towards the relatively infrequent, minor and transient discontinuation symptoms associated with SSRI therapy, clinicians may be well advised to focus their energies on the greater issues of efficacy, safety, and patient outcome.” The bottom line: concerns about discontinuation symptoms were overblown

Pollock was on the GlaxoSmithKline advisory board at the time, but he told ABC News that he had written the letter to the Journal of Clinical Psychiatry himself and had no knowledge of the draft letter prepared by the PR firm with his name on it. He did admit, however, that "could imagine a scenario where a representative from the makers of Paxil said, 'Could you make this point?'" According to ABC News, Pollock’s letter later appeared in an internal business plan guide prepared for GlaxoSmithKline sales reps. It cited Pollock's letter as "an effective tool for addressing discontinuation."

Writing about the Paxil fraud case last year in the Hastings Center Report, Leemon McHenry described today’s pharmaceutical company marketing strategy as “defending the molecule.” Rather than drawing conclusions from the evidence, wrote McHenry, the strategy is to select the data that promote the drugs, ignore the unfavorable data, pay a prominent academic to sign onto ghostwritten articles about the positive data, and publish the ghostwritten article in the best journals. Then you complete the circle by citing the ghostwritten articles in your marketing literature.

Actually, McHenry left out one crucial part of the circle. If you are the person who signs the ghosted article, you just may get a seat on an FDA advisory committee and a named chair at the University of Toronto.

Copies of Ruder Finn's letters can be found here:

PDF RUDER FINN (right click and save as)

PDF DR POLLOCK'S WAIVER BY THE FDA (right click and save as)

PDF DR POLLOCK'S CONFLICT OF INTERESTS (right click and save as)

Serotonin cannot be measured... says Dr

Dear Robert,

Your question about the proper chemical balance of Serotonin in the brain is difficult to answer. Serotonin levels, like the levels of other neurotransmitters in the brain, are in a constant state of change, depending upon our thoughts, feelings, and actions. Serotonin is released when needed (if available) and reabsorbed when not actively needed. Serotonin is released and absorbed in the brain on a minute-to-minute basis. It's similar to trying to estimate the "normal" level of muscle tension when muscle tension is a factor of what we are doing at the time such as relaxing, lifting weights, etc

The biggest problem in measuring brain Serotonin is the nature of the brain. It's a closed system and highly resistive to invasive procedures. Any attempt to sample brain fluid or tissue not only creates a high risk of infection but possible brain injury as well. While we can draw blood, spinal fluid, urine, etc for chemical analysis - we can't draw substances from inside the brain tissue. The closest we can come is a Positron-Emission Tomography (PET Scan - non-invasive) which can color-code and display levels of glucose metabolism and other chemicals in the brain. That fluid snapshot is still of the levels at the time - depending on the activity, feeling, and thoughts of the individual.

Over the years, attempts have been made to estimate Serotonin levels based on the byproducts of Serotonin as evidenced in blood or urine. Several "natural" or herbal labs on the internet have reported they can measure Serotonin levels, suggesting brain Serotonin. This is a false claim and they draw samples from urine and the gastrointestinal tract. Serotonin is located in the brain and gastrointestinal tract (that's why antidepressants give you an upset stomach). Levels of Serotonin in the GI tract are unrelated to levels in the brain.

In clinical practice, we must estimate the "level" of Serotonin in the brain by it's impact and influence on recognized and connected systems. Like muscle tension - the ability to use our muscles within a certain range of relaxation and lifting suggests normal levels. The inability to pick up a small object would suggest low muscle tension while spasms of the muscles would suggest abnormally high muscle tension. Changes in sleep, appetite, energy level, body temperature, etc. are recognized to reflect low levels of brain Serotonin - something confirmed by PET scans. Flu-like symptoms and dehydration are associated with too much brain Serotonin. During clinical examinations, we ask about physical and emotional symptoms related to neurotransmitter levels in the brain. Patient responses then dictate what medications might be appropriate to stabilize those levels.

In short, we can't accurately measure something we can't easily access, especially when the levels change on a minute to minute basis. All treatments associated with brain neurotransmitters are based on well-recognized clinical symptoms directly associated with specific neurotransmitters and supported by PET scan research. On-going research is focusing on better ways to estimate brain neurotransmitter levels but obviously, any accurate measure that can be used by a clinician in the community is still probably decades away.

While this response may not provide a number, percentage, or other accurate "normal" level for Serotonin, it may shed some light on the difficult task of working with neurotransmitters without using an invasive procedure.

Dr. Carver

Joseph M Carver, Ph.D.

Wednesday, January 03, 2007

Serotonin - GSK & The MHRA

Here is my latest FOI request to the MHRA:

Tuesday 2nd Jan 2007

FOI Request

Dear Sir/Madam,

Could you please provide me with answers to the following:

On the Seroxat Patient Information Leaflet (PIL) it states;

'Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain'

I would like to bring to your attention the statement in blue, 'People who are depressed or anxious have lower levels of serotonin than others.'

In a recent communication with your MHRA Vigilance and Risk Management of Medicines (VRMM) Division, I was told,

"...we are not aware of an internationally agreed "proper chemical balance of serotonin in the brain"

Therefore, this begs the question how Glaxo SmithKline can issue such a statement on their PIL for Seroxat?

1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?
Please answer Yes or No

2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?
Please answer Yes or No

3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the 'correcting effect' regarding people with lower levels of serotonin.

Meantime, I look forward to your reply.

Mr Robert Fiddaman


I will, of course, upload answers from the MHRA to this blog when I recieve them


Tuesday, January 02, 2007

Do the MHRA know 'What constitutes a proper chemical balance of serotonin in the brain?

...It seems not

----- Original Message -----
From: MHRA Information Centre
Sent: Tuesday, January 02, 2007 1:58 PM
Subject: FW: Serotonin

Dear Mr Fiddaman

In reply to your question of 4th December, please see the response below from our Vigilance and Risk Management of Medicines (VRMM) Division:

A variety of factors can contribute to an individual's predisposition to depression. Although it is believed that depression may be caused by a biochemical imbalance and it is recognised that serotonin plays a role in the development of depression it is considered that there is more than one final common pathway in the aetiology of depression, and we are not aware of an internationally agreed "proper chemical balance of serotonin in the brain" that would prevent or reduce the likelihood of experiencing depression.

As you are aware the role of the MHRA is to license medicinal products and ensure that medicines and medical devices on the UK market work, and are acceptably safe. As the precise role that serotonin plays in depression is still subject to ongoing research we really are not best placed to provide you with a response on this particular issue. You may wish to contact professional organisations such as the Royal College of Psychiatrists to seek their view on this matter.

I hope this is helpful to you.


Central Enquiry Point Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000


It seems that the MHRA are using their own definitions of the English language in their communications. One instance is their definition of the term 'Young Adult'.

Let's examine the following MHRA statement shall we?

"Young adults (18-29 years of age) are at a higher
background risk of suicidal behaviour than older adults and
therefore should be monitored particularly closely."

Firstly, a seach on Wikipedia for the term 'Young Adult' provides us with the following:

From Wikipedia, the free encyclopedia

Young adult refers to:

a person in the early years of adulthood

an adolescent

in human development, the stage between adolescence and adulthood, roughly ages 16 to 30.

Young adult (psychology), persons aged 20 to 40

in the Catholic Church, persons aged 18 to 34

in Unitarian Universalist circles, persons aged 18 to 35

Young adult literature, works targeted to ages 12 to 18.

in the computer game The Sims 2, "young adult" is the life stage associated with The Sims 2: University.

Basically, the MHRA are saying that the risk of suicidal behaviour is higher in 'young' adults up to the age of 29. In effect they think that if you are over the age of 29 then you DO NOT fall into the background risk of suicidal behaviour.

Now I find this quite absurd as each human being... or 'Young Adult' are made up of individual components. It seems the MHRA only think people between the ages of 18-29 should be monitored 'particularly closely' Bad news if you are 30+ then eh?

The MHRA need to change the wording from 'Young Adult' to 'Adult', there should be no age restrictions. Quite why they use this terminology is baffling - particularly as many of the adverse withdrawal reactions reported to them regarding Seroxat come from people over the age of 29.

Try this link on Wikipedia for the word 'Transparency'


Monday, December 25, 2006

GlaxoSmithKline staff told not to publicise ineffectiveness of its drug


Maybe these two will fuel that anger?

Email to Prof Kent Woods CEO of the MHRA
Dear Mr Woods,
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline.
It clearly shows that they witheld vital information during the clinical trials for Seroxat.With the evidence attached to this email I would like to know if you still stand by your original letter to me.
Mr R. Fiddaman Dip.Couns MOC & MSFTR
Group Moderator of the Online Seroxat Support Group
Dear Mr Fiddaman
I have already given you a full account of the Agency's position in this matter and there is nothing to add to it.
Prof. Kent Woods Chief Executive MHRA

Sunday, December 24, 2006


A recent FOI request to the MHRA was finally 'answered' by Andrew French, Group Manager, Licensing Division of the MHRA. I would be grateful if anyone out there could determine the definition of the cleverly constructed language he uses?

Mr Robert Fiddaman

19th December 2006

Dear Mr Fiddaman

REF: FOI 06/384

Thank you for your letter dated 21st November 2006 regarding a request under the Freedom of Information Act (FOIA), and which has been passed to me for reply. You raised several questions which I have reproduced below and which I will address in turn.

I also note from Sir Alasdair’s reply which you quote, that UK Public Assessment Reports (UKPARs) are mentioned. I should point out that UKPARs only came into being for medicinal products authorised in the UK on or after the 30th October 2005, and as such there was no UKPAR for Paroxetine / Seroxat. However,

Returning to your questions;

1) Please explain what is meant by "data". Does it mean

a) the mere existence of trials

b) company interpretation of data

c) the part of the company interpretation of data actually passed to the MHRA

d) the actual raw and complete data.

"Data" generally means the complete data package generated in support of the application submitted to the competent authority. This includes all data seen as both favourable and unfavourable to the support of the licence application as is required by the current European legislation. This data is normally provided in summary format and does not comprise the "raw data", although the regulatory authority can demand this if it is thought necessary. In the UKPAR, "data" are usually summarised rather than reported in full.

2) Will such "data" also include a listing of the data known to exist, but which the MHRA did not use to make its decision. (please answer only yes or no)

As stated above, all data, favourable and unfavourable, must be submitted.

3) Have the MHRA placed such "data" relating to Paroxetine/Seroxat on the MHRA website (answer yes or no). If yes, please refer me to such data

The report of the Committee on Safety of Medicines Expert Working Group on SSRIs was published on the website. This provided summaries of all the data, including clinical trial data, which underpinned the decisions of the group. In the case of paroxetine, clinical trial study reports were examined by the Agency in parallel with MAH analyses of their clinical trials. Link to data below.

4) The word "transparency" was used. Please supply a definition of this word as used in MHRA communications

The release of a national public assessment report for a medicinal product has two aims (i) to give transparency to the regulatory process, and (ii) to provide information on the product and the data supporting its authorisation or refusal. Transparency, as used, means providing all of the data on which the licensing decision was reached, together with the reasons for the opinion of the licensing authority, after deletion of any information of a commercially confidential nature.

I hope this information satisfies your queries

Yours Sincerely

Andrew French
Group Manager, Licensing Division

....and they call themselves transparent!


Friday, December 22, 2006

Health Select Commitee wash their hands of Seroxat!

I recieved a letter from my MP, Gisela Stuart who wrote to The Health Select Commitee on my behalf. As you can see they have now totally washed their hands of Seroxat, this, despite overwhelming evidence that the drug is unsafe.

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

Dr Ian Hudson is the MHRA’s Director of Licensing - but the job he had before he joined the agency was at GlaxoSmithKline - he was their Worldwide Director of Safety, and we know that one of the drugs he had “significant involvement with” was, in fact, Seroxat. (Also, the Chairman of the MHRA, Professor Alasdair Breckenridge, sat on Glaxo’s scientific advisory committee for many years.)

GlaxoSmithKline Secrets & Lies Part 2

Stuart Dollow, medical director of GlaxoSmithKline UK, "We published the results of all its studies on all drugs "whether negative or positive".

Stuart Dollow, medical director of GlaxoSmithKline UK

Product liability cases against drug companies like GlaxoSmithKline are often settled with an agreement that the potentially incriminating data found in the drug company files will be sealed or kept secret. In the case of Lacuzong v. GlaxoSmithKline, my report disclosed extensive manipulation of data concerning Paxil's adverse effects, including rates of suicidality, psychomotor agitation (akathisia), and over-stimulation. In a subsequent lawsuit against the company, my report was unsealed and is now available to the public. I placed the entire report on my website and published three scientific articles based on it.

Peter R. Breggin, MD


Panorama: Did GlaxoSmithKline act promptly in getting this information to you?

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Health and products Regulatory Agency

This is a matter which we are investigating at the present time. There is an investigation going on, being conducted by the.. one of this.. the inspection and enforcement sector of the agency and with lawyers to decide whether or not they did.

I enquired about this to the MHRA under the Freedom of Information Act. It has been over two years since this initial statement from Prof Sir Alasdair Breckenridge.

Here is the reply I recieved:

Thank you for your enquiry of 4th December 2006. I am writing to let you know that we are unable to supply the information you have requested. Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available. The information you have requested concerns a criminal investigation and is subject to the exemption contained in the FOIA, namely exemption 30. We have concluded that disclosing this information would not be appropriate because it would prejudice an ongoing criminal investigation. I am satisfied that both categories in exemption 30 are applicable;

a) where information has at any time been held for the purpose of specified criminal and other investigations or proceedings; and

b) where information relates to the obtaining of information from confidential sources and was obtained or recorded for a number of specified investigations or proceedings

Therefore it would not be in the public interest to disclose the outcome of the criminal investigation in advance of any potential court proceedings


...if you imagine a school of more than a thousand children all of whom are deeply troubled by depression, less than a small class size would have these suicidal thoughts or attempts, so it's a small but important signal…

Dr ALASTAIR BENBOW Head of European Psychiatry, GlaxoSmithKline

Thanks for that scenario Dr Benbow. You clearly show that you are a man full of compassion


There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults. There is a very large database.

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

What Prof Sir ALASDAIR BRECKENRIDGE fails to tell you is the MHRA have NOT examined the raw data, basically they examine the data that GSK give them, in other words they examine the positive data and NOT the negative data


More Coming Soon


Thursday, December 21, 2006

GlaxoSmithKline - Truth & Lies

Truth & Lies

"There is no reliable evidence that Seroxat can cause addiction"

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Despite thousands of yellow card reports, emails, letters and phone calls to both GlaxoSmithKline and the MHRA from patients suffering with addiction to Seroxat, does Dr ALASTAIR BENBOW still stand by this comment?


"Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drug to get the same effect and a number of other features, and these are not exhibited by Seroxat."

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

addiction -
well-defined physiological symptoms upon withdrawal; broadly : persistent compulsive use of a substance known by the user to be harmful.
the state of being enslaved to a habit or practice or to something that is psychologically or physically habit-forming, as narcotics, to such an extent that its cessation causes severe trauma.

addictive - Cambridge International Dictionary of English
An addictive drug is one which you cannot stop taking once you have started
dependence - The Wordsmyth English Dictionary
that which is relied upon

A spokesperson for GlaxoSmithKline commented: “Depression affects a huge number of people here in the UK - one in seven of the population at any one time.“It is a potentially deadly condition and Seroxat is an effective treatment that since launch, has helped tens of millions of patients worldwide lead fuller and more productive lives."

An all too familiar response that really diverts from the facts.
What happened in the UK when cattle were infected?
What happend when traces of salmonela were found in eggs in the UK?
Seems to be one rule for the farmers and one for the pharma's!



GSK's dirty tricks in competing class actions

Wednesday, December 20, 2006

By Steve Gonzalez - Edwardsville Bureau

It was a busy day for lawyers in the Paxil litigation in Madison County on Tuesday as a routine hearing to enforce an injunction branched into three separate, contentious hearings with two judges.

GlaxoSmithKline (GSK) filed a motion asking Madison County Associate Circuit Judge Ralph Mendelsohn to enforce an injunction which would prohibit plaintiffs in a similar St. Clair County Paxil class action suit from holding a certification hearing on Dec. 28.

But before Mendelsohn would issue a ruling he referred the case to Circuit Judge Barbara Crowder to hear a motion that sought to have him removed for cause.

In October the pharmaceutical agreed to allocate $63,833,148 and any obligations it may otherwise have to settle a class action case brought by attorney Stephen Tillery.

Tillery stands to reel in a whopping $16.8 million award in attorneys' fees.

The plaintiffs, Teri Hoormann, Mary Kopsie, and Bonita and Mark Helfer, alleged they suffered actual economic damages because GlaxoSmithKline promoted Paxil and Paxil CR for prescription to patients under the age of 18, while concealing negative information.

The preliminary settlement was approved Oct. 6 by Mendelsohn, the first day he was assigned to the case. The order was originally filed under seal, but was unsealed Oct. 27.

When issuing his order, Mendelsohn concluded that competing class actions would jeopardize his ability to rule on the settlement and would substantially increase the cost of litigation.

He further concluded competing class actions would also create risk of conflicting results, would waste court resources, and could prevent plaintiffs and the class members from benefiting from any negotiated settlement.

After Mendelsohn issued his preliminary settlement order, GSK entered motions to stay four other class actions pending throughout the country, including the St. Clair County case.

That's when the problems started.

Attorneys Chris Cueto of Belleville and John Driscoll of St. Louis, who represent Donita Baldwin -- a plaintiff in St. Clair County -- sent out a notice on Nov. 28 that they intended to hold the class certification hearing before St. Clair County Circuit Judge Michael O'Malley on Dec. 28.

According to GSK that violated Mendelsohn's injunction.

Cueto and Driscoll opposed GSK's motion and called Mendelsohn's injunction 'grandiose and absurd."

They argued to O'Malley that GSK's attempt to stay is among its latest attempt to further a course of action to deceive O'Malley, the public, and the putative class members so GSK can "enshroud their secret maneuverings and collusion with select claimants."

Cueto also argued that GSK failed to inform O'Malley that former Madison County Circuit Judge Phillip Kardis, who originally heard the case, placed it under seal on May 26, 2005, and removed it from the public view.

"In fact, beyond GSK there are only three people in the world that would have been granted access to the contents of the case file," Cueto argued.

"Yes, believe it or not, GSK had every single page of every single court filing in Madison County sealed and removed from the public," Cueto wrote.

Cueto said if O'Malley stayed the case, he would be complicit in secret maneuvering that GSK and Tillery are crafting.

He also said that Mendelsohn's claim in the preliminary settlement that he has "exclusive jurisdiction" is absurd.

"That is a powerful Circuit Court," Cueto wrote.

Cueto said there is no instance in which an Illinois Circuit Court ever had exclusive jurisdiction over anything.

Cueto also argued that GSK entered orders on two occasions that continued class cetification hearings.

He said that while it was by the agreement of both parties, it was only achieved due to GSK's deception.

"In discussing their desire to continue, GSK represented that they needed more time to conduct discovery on class issues," Cueto wrote. "It is now apparent that GSK was simply stalling my client and delaying this court while crafting a secret deal in Madison County."

O'Malley denied GSK's motion to stay on Nov. 20, but acknowledged that the plaintiffs and their counsel are subject to Mendelsohn's injunction and need to go to Madison County to take care of it before he can proceed.

Cueto and Driscoll then filed a motion to intervene, and followed that with a motion to remove Mendelsohn for cause and a motion to remove Mendelsohn as a matter of right.

They wanted to intervene claiming:

The settlement amount was inadequate;

There was apparent existence of a reverse action conducted by Tillery and counsel for GSK;

There was an attempt by the attorneys for the parties to enjoin and parallel proceeding while simultaneously representing the Hoormann case as an "opt-out" class action;

There is strong evidence of collusion by the parties to the detriment of the class;

The nature of the fees sought by Tillery should be questioned;

There is an insufficient and inadequate notice plan as mentioned in the preliminary order approving the settlement; and

There was inappropriate wholesale sealing of the Hoorman case from public view.

Mendelsohn would not hear any arguments on any motion until the substitution for cause was resolved.

Crowder held an emergency hearing and after hearing arguments ruled that Cueto and Driscoll did not meet the requirements to have Mendelsohn removed for cause.

Cueto argued Mendelsohn's injunction order was ex-parte and therefore was already biased against his client since he already ruled against her.

Crowder disagreed and said that an attorney cannot seek to remove a judge for cause just because he disagrees with the judge's ruling.

She then referred the case back to Mendelsohn for the hearing on motion to enforce the injunction and the motion for a substitution as a matter of right.

Mendelsohn ruled that he has already made a major ruling in the case and quickly denied the motion for substitution.

Dwight Davis of Georgia, who represents GSK, told Mendelsohn that he cannot allow Cueto and Driscoll to simply ignore his valid injunction.

"Rather than comply with this court's injunction, the plaintiffs are blatantly flouting it," Davis said.

Davis said Cueto's clients are members of the Hoormann settlement class, as are the absent class members they purport to represent. He said they cannot be prejudiced by the injunction since they can gain relief from the Hoormann class and pointed out the attempt to move forward in the St. Clair County case presents the very difficulties Mendelsohn intended to prevent.

"They are trying to undermine the settlement judge," Davis said. "I ask that everyday they continue to do so they be assessed a fine of $10,000 per day that would go to members of the class."

Mendelsohn ruled that Cueto did in fact violate the injunction but would not issue any fines. He indicated he would revisit any violations of the injunction should it be necessary.

Wednesday, December 20, 2006

Glaxo SmithKline Deny Seroxat Problems

The Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline, Dr Alastair Benbow, denied claims that the drug could be responsible for violence in users, saying there was no "reliable clinical evidence that Seroxat causes violence, aggression or homicide".

Let's see shall we?

Click on each link to read story.

A girl who shot a classmate in the shoulder at their Catholic high school three years ago has been released from state custody.

Dr ALASTAIR BENBOW Head of European Clinical PsychiatryGlaxoSmithKline

There is no reliable evidence that Seroxat can cause addiction

Don Schell was taking Paxil antidepressant when he killed his wife,
daughter and granddaughter

Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drug to get the same effect and a number of other features, and these are not exhibited by Seroxat.
Dr ALASTAIR BENBOW Head of European Clinical PsychiatryGlaxoSmithKline

Charges dropped after report links Seroxat [Paxil] to threatening behaviour

A spokesperson for GlaxoSmithKline commented: “Depression affects a huge number of people here in the UK - one in seven of the population at any one time.“It is a potentially deadly condition and Seroxat is an effective treatment that since launch, has helped tens of millions of patients worldwide lead fuller and more productive lives.

Family members and a neighbor said Stewart changed significantly after taking Paxil.


The kids are fine. Why are you always so anxious? Family and friends may not understand chronic anxiety - PAXIL Dad, you're always so tense. Are you mad at me? Honey you can't keep losing sleep, it makes you so irritable. You worry constantly, can't we have a relaxing dinner anymore? Chronic anxiety can affect your relationships, your work, your life.

Available by prescription only

10 Year Old Has Violent Incidents at School

GSK carried out trials of Seroxat on children from the late 1990s at the request of the American drug regulator, the Food and Drug Administration (FDA). But the results were kept secret because they showed that the drug had no more effect than a placebo, while there were some worrying side-effects. Of those on Seroxat, 3.2 per cent suffered mood changes including thoughts of suicide, attempted suicide and trying to harm themselves — compared to 1.5 per cent on placebo.

A document revealed in the Guardian earlier this year showed that GSK was determined to bury the bad news as long ago as 1998.

11 Year Old Boy is Violent & Suicidal on Paxil

Stuart Dollow, medical director of GlaxoSmithKline UK, said his company published the results of all its studies on all drugs "whether negative or positive".

12 Year Old Girl Commits Suicide

An internal strategy document proposed that GSK should not hand the data from two trials to the regulators. To admit the drug did not work in children would be ``commercially unacceptable ... as this would undermine the profile of paroxetine (Seroxat/Paxil)''.

12-Year-Old Driven Insane By Medicine

The Guardian (UK) reports (below) that BBC Panorama had obtained secret 1998 documents from SmithKline Beecham (now GlaxoSmithKline, GSK) showing that the company deliberately concealed the failure of Seroxat / Paxil to demonstrate a benefit for children in two clinical trials in children.

14 Year Old Girl Attempts Suicide

The MHRA was finally given the full trial data on May 27 last year (2003) later it announced it was banning the use of Seroxat in children.

14 Year Old Girl Becomes Suicidal & Violent : Lawsuit

The British manufacturers (GlaxoSmithkline) of an antidepressant drug that was last year banned from use in children knew as long ago as 1998 that it did not work and deliberately avoided publishing the full data because of the risk to their lucrative adult market, according to a leaked internal document.

A position paper dated October 1998 shows that managers at SmithKline Beecham - now GlaxoSmithKline - were concerned at the commercial implications of two clinical trials in which their drug Seroxat was given to children and adolescents with major depression.

The results of both trials, known as protocols 329 and 377, showed that the drug was no better than a placebo - an inert pill - in alleviating the children's depression.

14 Year Old Girl Kills Self

In 2002, more than two million prescriptions for Paxil/Seroxat were written for American children and adolescents alone, worth $55m in sales.

15 Year Old Girl Plans to Kill Mother, Brother & Self

A GSK press release: "... the company "has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies. All pediatric studies have been made available to the FDA and regulatory agencies worldwide. We have publicly communicated data from all pediatric studies."

15 Year Old Stabs his Grandmother

NICK ALCOCK Pharmaceutical Company Analyst Data monitor

In 1999 Glaxo SmithKline were estimated to spend around 30 million advertising Paxil in the US. In 2000 this figure had probably risen to just around 90 million.

15-year-old Sets Fire & Vandalizes School


With the help of Paxil you can see someone you haven't seen in a while - yourself. Hey, I remember you.

16 Year Old Girl Commits Murder: Kills Self in Prison

The manufacturers of the SSRIs, including GSK, have continuously and adamantly denied even the possibility of a causal connection and instead have blamed the victim and the ‘disease.

16 Year Old Girl Self Mutilates: Also Attempts Suicide

The 2003 memo cites a discredited published report in the Journal of the Academy of Child and Adolescent Psychiatry (2001, pp. 762-772) that maintained that Paxil was "safe and effective and well tolerated." It was co-authored by leading US child psychiatrists.

16 Year Old Kills his 17 Year Old Brother

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

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

16 Year Old: Paxil Still in Body 2 Months After Discontinuing Drug

GlaxoSmithKline has long denied that its drug could cause dependency. Last year one of its executives stated on ABC television in the US that "it happens very rarely".

16-year-old Attacks A Family

GLAXOSMITHKLINE: The information clearly says that Seroxat is not addictive and it is not.

17-Year-Old Murders His Friend (PDF File)

Why were GSK sales reps provided with information about suicide data and admonished NOT to inform physicians?

Glaxo spokeswoman Mary Anne Rhyne said the sales reps were instructed not to speak with doctors about the clinical-trial results because drug companies are forbidden from engaging in any activity that may be considered off- label promotion.

18 Year Old Girl Dies; Mother Campaigns

GLAXOSMITHKLINE: It's quite clear that the phrase "Seroxat is not addictive" was poorly understood.

19 Year Old Commits Suicide After Drastic Behavioral Change

Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Anybody who suffers side effects of any sort I feel every sympathy for, but that does have to be balanced by the enormous benefit that is seen by many millions of patients around the world.

20 Year Old Jumps from 24th Floor

Shareholders of GlaxoSmithKline have filed a class action lawsuit against the pharmaceutical giant for allegedly concealing problems with Paxil, its antidepressant drug for teenagers.

20 Year Old Shoots Self; Lawsuit Filed

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

We take every single safety report seriously. Absolutely every single one. And anybody… my heart goes out to anybody who experiences any of the symptoms of depression or the side effects related to the treatment of course.

22 Year Old Woman Kills Self

Sales for Seroxat amounted to almost $4.97 billion worldwide in 2003

64 Year Old Man Kills One in Road Rage Incident

GlaxoSmithKline last night denied that its drug caused adults to become hostile, although it acknowledged there had been a problem in the children's trials

77 Year Old Kills Self: Lawsuit

GSK, which for years denied there was a problem with the drug, has sent a letter to all doctors in Britain warning of the potential risk in some adult patients.

9 Year Old Girl Becomes Worse on Meds

GlaxoSmithKline, manufacturers of Seroxat, deny that the drug is addictive

Blind Man Kills Ex-Girlfriend

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

We are strengthening the information on side effects, particularly on stopping, so that there is greater clarity in terms of the exact wording

Coroner Calls for Drug to be Withdrawn

Seroxat is the biggest-selling SSRI (selective serotonin reuptake inhibitor) in Britain. In 2003 doctors wrote 19m prescriptions for the drug for patients with anxiety and depression.

Deputy Deliberately Crashes Car into House of Estranged Wife

Paul Flynn, Member of UK Parliament raised the antidepressant drug scandal in Parliament, focusing on the British drug manufacturer giant, GlaxoSmithKline (GSK). "The Seroxat [Paxil] scandal is one of gigantic proportions that affects millions of people."

Flynn notes: "Two years ago, GlaxoSmithKline wrote me a letter that contains very little that is truthful apart from the date. We know that its spokesmen made preposterous claims on "Panorama", and the letter states: "The safety and efficacy profiles of Seroxat has been confirmed through clinical trials involving thousands of individuals and the experience of tens of millions of patients over the 10 years the medicine has been available."

Indeed, the company's October 1998 internal confidential memo reveals the falseness of that claim:

Deputy Shoots Young Man

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Addiction is characterised by a number of different criteria which includes craving, which includes increasing the dose of drugs to get the same effect, and a number of other features and these are not exhibited by Seroxat

Diplomat Cleared of Drinking Charges

Sir ALASDAIR BRECKENRIDGE Chairman, Medicines Healthcare and products Regulatory Agency

The primary role of the MHRA is to protect the public health. It also has got a responsibility to ensure that only drugs which are effective and safe come to the market and remain on the market.

Drake Freshman Hangs Himself

Because of the small numbers, GSK says the findings should be interpreted with caution.
It adds that "all of the reported events of suicidal behaviour in the adult patients ... were non-fatal suicide attempts

Employee Kills Supervisor

"paxil has been proven safe and effective in the treatment of depression, panic attacks, obsessive compulsive disorders (OCD), social anxiety disorder (social phobia), generalized anxiety disorder and post-traumatic stress disorder (PTSD)"

Exec Steals $1.2 M

Dr ALASTAIR BENBOW Head of European Psychiatry , GlaxoSmithKline

The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm

Father Drowns Two Children: Kills Self: Lawsuit

GlaxoSmithKline, which earned £100 million last year from UK sales of Seroxat, has always denied there was "compelling evidence" linking SSRIs with suicide.

Father Kills Self on Paxil: Daughter Attempt Suicide on Paxil

GSK says in the letter that it "continues to believe that the overall risk:benefit of paroxetine (Seroxat) in the treatment of adult patients" with depression and other disorders "remains positive"

Father Murders Epileptic Son

RICHARD BROOK Chief Executive, Mind

If the regulator does nothing now and further people die, and ultimately it was proved to be something in relation to Seroxat, then the Regulator would be guilty. The Regulator must resolve this issue.

Former Corrections Officer Murders Girlfriend

Every minute, more than 1,100 prescriptions are written for GSK products worldwide.

Grandmother Shakes Baby

On 'emails from the Edge', Dr Benbow said he had "every sympathy" for any patient suffering from side-effects, and that changes to the PIL would ensure there would be "greater clarity in terms of the exact wording".
He also denied claims that Seroxat is responsible for self-harm and suicidal behaviour in patients who have otherwise not shown such behaviour.

Husband Stabs Wife

Panorama: Did GlaxoSmithKline act promptly in getting this information to you?

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Health andproducts Regulatory Agency

This is a matter which we are investigating at the present time. There is an investigation going on, being conducted by the.. one of this.. the inspection and enforcement sector of the agency and with lawyers to decide whether or not they did.

Large Doses Impairs Judgment

GSK Culture:

Performance with Integrity - Delivering on promises with organisational and individual trustworthiness.

Lawsuit Filed on Behalf of Child Born with Heart Defects

Dr ALASTAIR BENBOW Head of European Psychiatry, GlaxoSmithKline

...if you imagine a school of more than a thousand children all of whom are deeply troubled by depression, less than a small class size would have these suicidal thoughts or attempts, so it's a small but important signal…

Man Assaults Family with Handgun & Knife

Alan Chandler, a spokesman for GSK denied Seroxat was caused dependency, withdrawal symptoms or violent tendencies.

Man Attempts Murder & Kills Self

GSK yesterday rejected any accusation of dragging its feet on the data on suicidal behaviour in depressed adults

Man Attempts Suicide

Dr ALASTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Whilst self-harm and suicidal thoughts are clearly a feature of depression, they have not been shown in carefully done studies to be a feature of treatment with these medicines.

Man Becomes Violent at Airport

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

There is very good clinical trial evidence that these drugs do not cause suicide, they do not cause suicidal thoughts in adults. There is a very large database.

Man Dressed as Santa Robs Banks

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

In the adult population the drugs are effective.

Man Has Severe Reaction to Paxil

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

There is a period of time when the drug does not act, it takes a period of 3 or 4 weeks before effect.

Man Kidnaps Wife: Sprays Acid in her Face

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare and products Regulatory Agency

It’s very important that since safety is an issue which is built up as more experience is gained with the drug, that safety is kept under review and this is why we insist on post marketing surveillance of a drug, which means that its safety is kept under review during its lifetime.

Man Kills Four: Wife, her Two Children & Mother

Chair, Medicines Healthcare and products Regulatory Agency

It is a matter of regulatory and practical judgement as to when information should be transmitted. When it is in the public’s interest that information should be transmitted rapidly, we will do it

Man Kills Police Officer

Chair, Medicines Healthcare andproducts Regulatory Agency

It takes time for clinical trial evidence to become available.

Man Kills Policeman & Self

Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

Now not everybody who tragically takes their own life will say to people: "I'm feeling suicidal, I'm going to kill myself." In fact many people who have decided that they're going to do that, deliberately withhold that information from their friends and family.

Man Kills Wife & Daughter: Attempts to Kill Another Daughter

Chair, Medicines Healthcare andproducts Regulatory Agency

There is no other agency which has kept these.. these drugs under such constant and careful review since 1990 as we have done and we will continue to do so in the interests of the public health.

Man Kills Wife & Himself (PDF File)

Dr ALISTAIR BENBOW Head of European Clinical Psychiatry GlaxoSmithKline

We have been asked by the regulatory authorities to provide all our information related to suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an increased risk of suicide – no link.

Man Murders Estranged Wife


GlaxoSmithKline sued by Tim Tobin after this father-in-law Donald Schell killed himself, his wife and his grand daughter in Gillette, Wyoming, USA, after being on Paxil (Seroxat ) for only two days.“I felt that something had almost turned him into a monster and the Don that I knew wasn’t that type of person. The only thing that had changed was the medicine he was taking, the Paxil [the US brand name for Seroxat].” Tim Tobin, Panorama, BBC, 2002Donald Schell had apparently been depressed for the previous ten years - but not suicidal. He had taken just two Paxil (Seroxat ) tablets in two days, before he killed his family. The jury found GlaxoSmithKline to be negligent and awarded more than $6mn (£3.8m) in compensation.

Man Murders Two: Lawsuit

June 11 2001:

Thousands of people in the UK could be hooked on the anti-depressant drug Seroxat, without knowing it.Dr David Healy, a UK expert in antidepressants, has said he has seen records of trials carried out by the manufacturers which showed healthy volunteers were suffering withdrawal symptoms after taking the drug for just a couple of weeks. Dr Healy was given access to GSK’s archives because he was an expert witness in the Schell case.

Man Murders Wife & Has No Memory of It

June 14 2001:

People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK.For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat - Paxil in the USA - was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself.

Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency in the UK.What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy?

His position is that an individual case cannot tell you one way or the other - only randomised controlled trials will do.

Man Never Diagnosed with Depression Kills Self

Alan Metz, GSK North American medical director told the Wall Street Journal: “Each time it hs been looked at, there is no suggestion of an association with suicidal tendencies in adults

Man Pulls Gun on 3 People

GSK has not carried out that sort of study to establish whether or not Seroxat can make people agitated, suicidal, murderous or hooked. Nor has it carried out a randomised controlled trial. Here is a black hole. There is no proof that the drug does these things, says GSK, and because of that there is no reason to carry out trials that might decide it one way or the other.

Man Robs Congregation Waving Sword

July 10 2001:

People prescribed anti-depressant drugs like Prozac and Seroxat by their GP may be at increased risk of suicide soon after starting the medicine, the British pharmaceutical company GlaxoSmithKline has acknowledged.

Man Sentenced to Life After Brutal Murder

July 2002:

The Guardian reveals that Seroxat tops the league table for complaints of side-effects made by doctors to the government’s committee on the safety of medicines under the yellow card scheme. A total of 1,281 complaints were filed - more than the combined total for the rest of the top 20 most cited drugs.The watchdog group Social Audit complained about the wording on the Seroxat patient information leaflet. It states that “these tablets are not addictive”, and that withdrawal problems “are not common and not a sign of addiction”.

Man Set Girlfriend on Fire

October 13 2002:

The Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline has denied that the drug Seroxat can lead to addiction. In an interview with Panorama, Dr Alastair Benbow said the drug was well tolerated and had been used all over the world for a decade. Dr Benbow also added: “As with all prescriptions medicines, Seroxat does have side effects, but these are clearly stated in the information that’s made available to doctors and to patients.”

Man Shoots Father Holding Child

October 13 2002:

One of the most widely used anti-depressants in the world can be addictive, it has been claimed. The claims - made on Panorama - come as the makers of Seroxat are attempting to have their drug licensed for use by children in America.

Man [66 Years Old] Murders Wife

Now, GSK admits the drug is associated with increased risk of suicide attempts in adults, but only in young adults

Mom Murders Her Two Children

January 8 2003:

Experts are looking at the safety of widely used antidepressants including Prozac and Seroxat. The review will look at a range of options, including whether the drugs should be banned. The government review began after members of the public and doctors raised concerns that the drugs can be addictive, contrary to manufacturers’ claims - and increase the risk of suicide in some patients.

Mother Drugs her Children

March 11 2003:

A coroner calls for an inquiry into the widely-prescribed anti-depressant drug Seroxat. Powys coroner Geraint Williams has written to the UK Health Secretary to ask for an urgent inquiry and for the drug to be withdrawn from use.It follows the death of a man from Brecon who killed himself two weeks after being prescribed the drug for anxiety - the coroner recorded an open verdict on Tuesday.

Mother Kills 2 Sons & Self

May 11 2003:

The makers of the popular anti-depressant Seroxat have denied claims that their product is addictive and causes suicidal feelings. Speaking on BBC One’s Panorama programme, Dr Alastair Benbow, head of European clinical psychiatry at GlaxoSmithKline, admitted that people could have misunderstood the information on patient leaflets which said the drug was not addictive.

Mother Kills 6 Year Old Daughter & Self

May 11 2003:

GSK, which makes the anti-depressant Seroxat is to drop the wording that it is “not addictive” on its patient leaflets. The move by the drugs giant follows complaints from viewers of BBC One’s Panorama programme, who complain of severe withdrawal symptoms and say they have been unable to stop taking the drug.

Mother Kills her 4 Year Old Twin Sons

May 27 2003:

The government is launching a major inquiry into the safety of some of the most prescribed anti-depressants, including Seroxat. An expert group of the Committee on Safety of Medicines is to be set up to look at the problems some patients have reported while taking selective serotonin re-uptake inhibitors (SSRIs), which include Seroxat and Prozac.And for the first time ever, the inquiry will take first hand reports from people who claim to have problems and investigate reports of suicidal behaviour.

Mother Set House on Fire with 6 Year Old Son Inside

June 9 2003:

Experts are set to update the safety advice provided with the controversial antidepressant Seroxat. The drug has been at the centre of a storm amid claims that it is addictive and could increase the risk of violent behaviour in some patients. Its maker, GlaxoSmithKline, insists that it is a safe drug - prescribed to thousands of patients in the UK.

Mother Turns Gas On While Children are Near

June 10 2003:

Young people under the age of 18 should not be prescribed the controversial drug Seroxat, government advisors have ruled. It follows a review which found children taking the anti-depressant 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.

Neighbor Runs Amok: Tries to Set Police on Fire

June 25 2003:

GSK quietly revise prescribing instructions for Seroxat. The company upwardly revises its 2002 estimate of the risk of withdrawal reactions – from 0.2% to 25%.The official risk of Seroxat withdrawal problems had increased overnight from 1 in 500 to 1 in 4.

Pilot on Medication: Six Dead

November 20 2003:

A system designed to highlight dangerous side-effects of medicines is not working, claim researchers. Doctors, and other health professionals are supposed to notify watchdogs if a patient reports an “adverse effect”. However, a researcher from the University of Oxford says that this information is wasted because it is not analysed properly.

Postpartum Depression: Mother Murders Son

February 3 2004:

Drugs giant GlaxoSmithKline knew that the anti-depressant Seroxat could not be proved to work on children in 1998, according to a leaked internal document.The secret document, relating to two clinical trials held in the 1990s, reveals that drug trials had shown little or no effect on helping depression in minors.

The company was also advised to avoid publishing the full data because it would be “commercially unacceptable” and would “undermine the profile” of the drug.The confidential paper, sent anonymously to BBC’s Panorama programme, reveals that the company were advised to publish only the positive aspects of one study and that there were no plans to publish a second - more negative - study.

Postpartum Depression: Wife Stabs Husband

March 2004:

In the USA, The FDA calls for label change for all major antidepressants urging doctors to closely watch both adults and young people for suicidal tendencies and increased depression.

Public Safety Director Commits Suicide

March 11 2004:

Experts have warned doctors not to start patients on high doses of the antidepressant Seroxat. The Committee on Safety of Medicines says patients should initially be given a dose of 20mg a day.

Reporter Writes About her Mother's Suicide

March 13 2004:

The head of mental health charity Mind has resigned from a review of anti-depressants accusing a government drugs watchdog of negligence.Richard Brook acted after GPs were advised to limit doses of the anti-depressant Seroxat.

He claims the Medicines and Healthcare products Regulatory Agency (MHRA) knew about the concerns for 10 years and he was pressured not to reveal them.

Singer Elliott Smith Stabs Self Twice (PDF File)

June 2 2004:

UK drugs group Glaxosmithkline (GSK) has been sued in the US for allegedly lying about the effectiveness and safety of its antidepressant Paxil.

Social Drinker Becomes a Drunk

June 18 2004:

GlaxoSmithKline has announced plans to publish clinical trial results for some of its medicines on the internet.

Student Deliberately Crashes Car into Building

August 2004:

In the USA, The FDA posts new analysis that shows evidence of a link between the drugs and suicidal thoughts or actions in young people.

Suicide of Police Sgt After Stand-Off with Fellow Officers

August 27 2004:

GlaxoSmithKline has agreed to publish results of clinical tests on its drugs, to settle a US lawsuit.

Teacher Sets Herself on Fire

September 2004:

GlaxoSmithKline (GSK) is facing a US lawsuit alleging that it covered up negative research findings on its anti-depressant drug Paxil.The lawsuits were filed on behalf of children and teenagers who were prescribed Paxil, known as Seroxat in the UK and Europe.

Teen Becomes Psychotic (PDF File)

October 15 2004:

The FDA, in the USA, orders that a “black box” warning be included on all antidepressants.

Two Day Withdrawal: Man Kills & Kidnaps

December 2004:

In the USA, ABC News uncovers internal documents that suggest GlaxoSmithKline, maker of the popular antidepressant Paxil, was aware that the drug had little or no effect in treating depression in children and adolescents, and that it may cause suicide-related behaviours in young patients. In spite of this information, GlaxoSmithKline distributed a memo to its sales force in 2001 touting the drug’s “remarkable efficacy and safety in the treatment of adolescent depression.”

Two Dead in Plane Crash

February 18 2005:

Modern antidepressant drugs like Prozac and Seroxat may make patients twice as likely to try to kill themselves than if they were not taking any pills at all, according to a new study published today.The British Medical Journal published three studies on SSRIs (selective serotonin reuptake inhibitors).

Two of the studies look at reported suicides and suicide attempts in trials undertaken by the drug companies before applying for a licence.The larger of the two, by Dean Fergusson of the Ottawa Health Research Institute in Canada and colleagues, looked at data from 702 published trials which included 87,650 patients.

It found a twofold increase in the risk of a suicide attempt on the drugs. The increase is still small - 5.6 attempts per thousand patient years - but, they say, it is significant because of the widespread use of the drugs.The authors say there may be a larger problem because they believe that some suicide attempts were not recorded.

Victory for 'Drug Battle' Man

March 22 2005:

The Select Health Committee publishes The Report of the Fourth Session 2004-05 entitled The Influence of the Pharmaceutical Industry.From the MHRA, Professor Alaisdair Breckenridge (Chairman), Kent Woods (CEO) and June Raine (Director of Vigilence and Risk Management) are asked to attend a hearing for questioning in January 2005. Also from the MHRA, Ian Hudson is asked to attend but does not.

Prior to joining the MHRA, Hudson was Worldwide Director of Safety at GlaxoSmithKline, with a significant involvement in Seroxat. During the hearing, angry MPs are unable to ask specific questions regarding the safety and trials of Seroxat due to Hudson’s non apperance.

Among its recommendations, the Report calls for more control over the way Pharmaceutical companies market their drugs, as well as calling for a complete review of the MHRA itself. The MHRA appoints a Director of Communications (Marketing and PR).

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August 22 2005:

Commonly used modern antidepressants can cause adults as well as children to attempt suicide, a new study says.An 18-month inquiry convened by the Medicines and Healthcare Regulatory Authority (MHRA) in the UK banned the use of the drugs, known as the SSRIs (selective serotonin reuptake inhibitors) in children and adolescents.

Last December it said the drugs were over-prescribed though they could safely be used by adults.But a study published today in the online journal BMC Medicine casts doubt on the MHRA’s findings.

One of the manufacturers, the British company GlaxoSmithKline, which makes the bestselling Seroxat, did not submit its original detailed data from clinical trials of the drug to the regulator, said the Norwegian author of the report, Ivar Aursnes. “I think the UK investigation could have been even more thoroughly done if they had looked through the primary data,” he said.He had attempted to alert the MHRA to his findings, he said. “I have tried but they have not shown any interest.”

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September 9 2005:

GPs give little support to millions of patients who would like to come off antidepressants because they cannot stand the side-effects, the mental health charity Mind said today.It found doctors wrote 29m prescriptions for antidepressants and 17m for anti-anxiety and sleeping pills in England last year.GPs were keen to hand out the drugs, but they were not able to tell when patients were ready to come off them - and not good at helping them do so, the charity said.

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September 28 2005:

Doctors were yesterday told to stop giving antidepressants to children and people under 18, because of the risks that the pills will make them feel suicidal.The new NHS guidance marks a watershed in the treatment of children’s mental health.

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February 27 2006:

A previously sealed product liability report against Glaxo SmithKline (GSK) is published. The medical expert report documents how the company systematically hid and manipulated data concerning Seroxat (Paxil) induced suicidality in depressed adults.

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GSK hid the incidence of Paxil-induced akathisia (agitation with hyperactivity) and stimulation. Akathisia and stimulation are risks factors for suicidality and violence. The product liability report also cites previously unreleased FDA correspondence critical of GSK’s marketing and advertising tactics in regard to Paxil. The entire product liability report is reproduced on and is based on a three-day examination of GSK’s sealed files at the company’s headquarters.

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April 10 2006:

In an email to anti Seroxat campaigner, Robert Fiddaman, Prof. Kent Woods, CEO of the MHRA, stands by Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants, stating that “I have already given you a full account of the Agency’s position in this matter and there is nothing to add to it.”This, despite recent new evidence suggesting that the Expert Working Group did not have access to all the clinical trial data as recently published in Dr Peter Breggin’s report.

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May 2006:

GlaxoSmithKline (GSK) submits documents to the FDA in the USA and other regulatory agencies worldwide, contradicting its decade long denial that its antidepressant drug, paroxetine (Paxil/Seroxat) increased the risk of suicidal behaviour in the company’s controlled clinical trials. GSK insists the timing of the warning, made so soon after Dr. Peter Breggin’s previously sealed product liability report against Glaxo SmithKline was made public, has nothing to do with that document.

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In a letter to healthcare professionals, GSK warns about the increased suicide risk stating: “There is a possibility of an increased risk of suicide related behaviour in young adults ages 18-29” - whether the drug is prescribed for depression or for other conditions not associated with suicide.

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June 21 2006:

Petition presented to the House of Common by Stewart Hosie MP: “I take enormous pleasure in presenting a petition on behalf of my constituent, Mr. D. Scott, from Dundee, who calls for the precautionary principle to apply to the prescription of Seroxat. He points out that many people who are prescribed Seroxat believe that they suffer side-effects, including aggression, fatigue, agitation and suicidal thoughts. Others suffer severe effects on withdrawal. He observes that a large amount of information on those side-effects is in the public domain, and he demonstrates the requirement for immediate action, including a moratorium on the prescribing of Seroxat to new patients”.

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September 12 2006:

Study links violence with antidepressants.The antidepressant drugs known as SSRIs, which include the British best-seller Seroxat, may precipitate a small number of individuals into violence, according to a paper published today on the Public Library of Science: Medicine website.David Healy of Cardiff University, David Menkes of the University of Auckland and Andrew Herxheimer of the Cochrane Centre reviewed data from several sources including Seroxat’s manufacturer, GlaxoSmithKline. “The new issues highlighted by these cases need urgent examination in all countries where antidepressants are widely used,” they write.

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Dr Ian Hudson

December 20th, 2006 —
While I’m thinking about the MHRA, here’s something else I want to share with you. The MHRA is not funded by the taxpayers of the UK - rather, it is entirely funded by the Pharmaceutical industry - it takes fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income.
The links between industry and the MHRA are very, very close.
Dr Ian Hudson is the MHRA’s Director of Licensing - but the job he had before he joined the agency was at GlaxoSmithKline - he was their Worldwide Director of Safety, and we know that one of the drugs he had “significant involvement with” was, in fact, Seroxat. (Also, the Chairman of the MHRA, Professor Alasdair Breckenridge, sat on
Glaxo’s scientific advisory committee for many years.)

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.
MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

Roger Cleghorn, UK Seroxat Campaigner

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In relation to the use of SSRIs in young adults the Expert Working Group concluded that there is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over. However, given that individuals mature at different rates and that young adults are at a higher background risk of suicidal behaviour than older adults, as a precautionary measure young adults treated with SSRIs should be closely monitored. The Group also recommended that in further research on the safety and efficacy of SSRIs, young adults should be assessed separately.

Professor Kent Woods
Chief Executive MHRA

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You also mention the recent tragic events relating to the young men who suffered serious unexpected adverse drug reactions during the healthy volunteer trial conducted by Parexel at Northwick Park. The immediate priority was to suspend the trial to ensure that no further individuals were harmed. The MHRA has now begun an exhaustive investigation to determine the cause and to ensure that all appropriate action is taken

Dr. Julie Williams Vigilance and Risk Management of Medicines (VRMM) MHRA

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The available clinical trials with Seroxat (paroxetine) were evaluated rigorously during the Expert Working Group’s review. However, I have asked Departmental officials to carefully consider the concerns you have highlighted and Dr Breggin’s report including his claims that GSK has suppressed data, which clearly show paroxetine treatment, may increase the risk of suicidal behaviour in adults. If the claims are substantiated then of course appropriate action will be taken.

Dr. Julie Williams Vigilance and Risk Management of Medicines (VRMM) MHRA

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Robert Fiddaman: Can you confirm that the patient who committed suicide at 17 days had received ECT treatment three days earlier?


Dr Panos Tsintis
Head of Sector, Pharmacovigilance and safety and efficacy
of medicines, Post-Authorisation Unit

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Prof Sir ALASDAIR BRECKENRIDGE Chairman, Medicines Healthcare and products Regulatory Agency

It was a very dramatic change in our thinking about Seroxat in children. Remember Seroxat has never been licensed in children. It has never been licensed in children at all, but nevertheless practitioners have, on their own behest, have used it extensively. Our best evidence is that some 7,000 children a year were.. or children and adolescence were receiving Seroxat.

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Email to Prof Kent Woods
CEO of the MHRA

Dear Mr Woods,

As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline.(See Attached) It clearly shows that they witheld vital information during the clinical trials for Seroxat.

With the evidence attached to this email I would like to know if you still stand by your original letter to me.

Mr R. Fiddaman Dip.Couns MOC & MSFTRGroup Moderator of the Online Seroxat Support Group

Dear Mr Fiddaman

I have already given you a full account of the Agency's position in this matter and there is nothing to add to it.

Prof. Kent Woods
Chief Executive

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