“…Study 329 seems to fit the classic picture. It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake…”
“..In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults…”
“…Yet this BMJ study deals an especially sharp blow, for it’s only rarely that researchers are able to crack open the tightly sealed file cabinets of drugmakers and look at raw trial data. ”
The MHRA (The UK Medicines Regulator) has been utterly toothless in regards to bringing GlaxoSmithKline to book over the appalling Seroxat scandal. Seroxat was first licensed in 1991, therefore effectively for 25 years the MHRA has allowed GSK to make a profit off a drug which has killed, harmed and maimed many people. This drug should have been pulled from the market in 2001 when the first BBC expose about the dangers of Seroxat suicide, violence and withdrawal first surfaced. However, considering the current MHRA CEO, Ian Hudson, is a former long time GSK employee, who testified in favor of Seroxat (Paxil in the US) before he left to join the regulatory industry, I won’t hold my breath for the MHRA to act in patients’ interests any time soon. They are clearly more interested in protecting Pharma before patients.
In October this year, the BMJ (British Medical Journal)- the most esteemed medical journal in the world- published a damning re-interpretation of a study on Seroxat (study 329). Although, this study showed how dangerous Seroxat is in the under-18’s age group, it also opened up a can of worms about the safety of Seroxat in all age groups. If Seroxat is lethal in under-18′s, and causes them to commit suicide, self harm, and causes other horrible side effects, and the MHRA agree with these findings, then why do the MHRA dispute that Seroxat can cause the same effects in adults? It’s like saying that cyanide is not for kids, but adults are ok. It’s just simply absurd to say that Seroxat is in any way safe for adults; particularly in 2015.
Bob Fiddaman, the author of the Seroxat Sufferers Blog, has been asking the MHRA a very interesting question regarding Seroxat’s ‘safety’ profile; a question which I have been trying to draw attention to also on this blog for quite some time-
With respect, you have not answered my question. I am already aware of the Expert Working Group and their findings.
My question, which I believe, you have not answered, is…
If a patient, at the age of 16, suffers suicidal thinking whilst on paroxetine – but continues to take paroxetine and continues to feel suicidal thoughts. What happens when they reach, 25, 26 or 27, do these suicidal thoughts magically disappear?
The question we are asking here, is extremely important, and it bring the entirety of Seroxat prescribing into question.
The MHRA admit that Seroxat should not be prescribed to under 18’s because it can increase suicidal thoughts in those age groups. But, what happens when an individual is prescribed Seroxat when they are under-18 but continue on it until they are over-18? Does the risk magically disappear?
This question is important because it’s ridiculous to assume that risks from a drug would change so dramatically just because of an over-18 threshold. We don’t automatically change into an adult body, or suddenly become completely different psychologically, biologically or behaviorally, when we turn 18. Growing up, maturing, and the changes which take place both physically and psychologically, happen over a gradual period.
The adolescent brain is different than the young adult brain, and the same could be said for a young adult and an adult’s brain. Nonetheless, peoples’ brains do not suddenly change from adolescent to a young adult on their 18th birthday. The age 18 threshold in regards to Seroxat side effects is ridiculous.
According to recent findings, the brain does not fully mature until at least 25 anyhow, and furthermore, it is also arguable that prescribing an SSRI drug over a long period of time could affect how the young adult brain develops. If SSRI’s cause birth defects so easily, I dread to think what kind of damage they do to our brains (at any age).
Millions of adolescents were prescribed Seroxat (Paxil/Aropax) when they were under 18, particularly in the late 90s/early 2000’s and many of them had serious reactions, but they weren’t warned of the dangers, so many they stayed on the drug until they were over-18, even though it was doing them damage. Many of these teenage Seroxat casualties could not come off it because of the severe withdrawal reactions Seroxat induces, some stayed on it well into adulthood. Some committed suicide because of Seroxat, some got off, and some are still enslaved to it.
The issue of Seroxat causing so much harm to under’18s raises a huge red flag for Seroxat in all ages groups, a red flag which many have been trying to draw attention to for over a decade now. However, the MHRA have no interest in Seroxat harming adults, or children, or Seroxat harming anyone in fact. After 25 years of constant bad press, and clear evidence that Seroxat is a dangerous drug, the MHRA continue to allow it on the market. Why?
Personally, I believe that the MHRA possibly suspect that Seroxat is lethal, but if they pulled it now (after all these years of ineptitude), or admitted that Seroxat harms adults in the same way, they would open themselves up for obvious negligence, and an admittance would open too many cans of worms, therefore they continue to deny, ignore or obfusticate because that’s the only way they know how to deal it. If they were to acknowledge the truth about Seroxat, that would open their whole regulatory system up to scrutiny. Seroxat was the ‘canary in the coalmine’. It serves as a warning that we are not safe, just like thalidomide did in the 1960’s. If we can’t trust the pharmaceutical companies, and we can’t trust the data on their drugs, and we can’t trust the regulators to keep us safe from harm, how do we trust in the efficacy of any pharmaceutical products? We can’t, and we shouldn’t.
The MHRA’s response to Bob Fiddaman on the question of Seroxat harming under-18’s (but still being prescribed to over-18’s despite the known risks) and the conundrum that is presented within the question itself, is the typically glib and sarcastic response that they have been giving for years now. They simply must not care that Seroxat has killed and maimed many people. If they did they would have done something about it by now..
But as we can see from their dismissive response to Bob Fiddaman, they will do anything to avoid opening the Seroxat can of worms..
Dear Mr Fiddaman,
Thank you for your email.
This is a theoretical question which we are unable to respond to as a patient’s health condition will vary for each individual. The clinical care of a patient is the responsibility of their doctor; healthcare professionals are recommended to closely monitor their individual patients on SSRIs for suicidal thoughts and discuss their symptoms with them to determine the best course of action with regards to possible treatment.
Medicines and Healthcare Products Regulatory Agency
It’s interesting how the MHRA are trying to deem that Bob’s question is merely theoretical. It may be theoretical in the way it is phrased, but it is also a real question based on real scenarios, and there are many under 18’s who were prescribed Seroxat and had serious adverse reactions, but because they were in the dark at the time of being prescribed Seroxat, they continued on the drug until adulthood.
The ‘theoretical’ scenario which the MHRA are trying to denigrate and dismiss actually happened to many people. It’s not astrophysics. These events happened to people, and people suffered for it. This is not ‘theoretical’- many people have been harmed from Seroxat. That’s a fact.
It seems to me that when people question GSK about Seroxat they are told to talk to their doctor, but when they ask their doctor their doctor says that its the regulators responsibility to keep us safe from harmful drugs and that they are not responsible for it. If we question the regulator about our concerns about Seroxat, the regulator also tells us that its the doctors responsibility, not theirs. So effectively patients are pushed upon a never ending ‘circle of pass the buck’ with nobody ever taking responsibility. This is just not good enough. Patients deserve better.
I will be interested to see what the MHRA have to say in response to Bob’s last question to them. Their obfuscation tactics, in regards to avoiding the Seroxat Scandal, are really wearing thin after 25 years..
Keep an eye on Bob’s blog for more on this-
Then, based on your answer, pediatrics and adolescents taking SSRi’s off-label are at risk of suicidal thinking but when they reach a certain age (26) they are not at risk, that risk, according to the MHRA SSRi prescribing guidelines, magically vanishes?Currently, SSRi’s are not recommended for anyone up to the age of 25 years, correct?How did the MHRA arrive at this? Was it based on a set of theoretical circumstances?Please explain, in detail, how the MHRA arrived at the decision that any person up to the age of 25 is at a higher risk that those over the age of 25, ie; what criteria did you use?SincerelyBob Fiddaman
Who the hell is Alastair Benbow, I hear you say? ..
The name Alastair Benbow sends shivers down the spines of many Seroxat Sufferers (and for some it has them reaching for the sick bucket.. and those are the one’s who are not in withdrawal!)
Alastair Benbow’s BBC panorama interviews (from the outstanding Seroxat documentaries) are a paradigm of bad PR Fuck Up’s…
Basically, Mr Benbow was carted out for damage limitation by GSK when the truth about Seroxat was documented by the BBC. Mr Benbow’s performance in defense of Seroxat for GSK on British TV can only be described as outstanding(ly bad)..
The sheer depth of his inhuman response gives us a great insight into the sociopathic tendencies of those whom rise to the top of major multi-national corporations… Not that I’m saying that Alastair himself has these tendencies… perhaps he was genuinely misguided.. Or maybe he was off-mood that day… Who Knows? ..I guess we can only speculate… But.. You can’t help but look into those pale icy blue eyes, below that furrowed and lined faux-concerned brow, on that robotic little condescending head and wonder?… What the hell were you thinking Dr. Benbow?… Seriously? …
Or as we say around here.. Are you for fucking real?
From Bob Fiddaman...
The Drug Industry Document Archive [DIDA] has obtained and released over 200 previously unseen court files from various Paxil litigation cases. Browsing through them last night was akin to losing £10 then later finding £100…make that a £1000
The Project on Government Oversight [POGO] is an investigation into ghostwriting in academia. They have managed to obtain many files, one of which I shall be highlighting today.
The file in question has, to my knowledge, never been seen before, it’s 19 pages long and is a transcript from an interview given by Glaxo’s Alastair Benbow to BBC TV’s investigative reporter Shelly Jofre back in 2002. What makes this transcript so unique is that much of it was never actually aired on BBC TV when the interview went out.
You will see how Jofre pushes Benbow for answers, answers that he just does not want to give. You will see Jofre push him for answers on the withdrawal issue regarding Paxil [Seroxat] and. time and time again, you will see how Benbow avoids the question.
Benbow has mastered the art of deflection but Jofre is an ankle biter – she just does not let go.
These files are like gold dust, I am highlighting this one in particular because I think it is important to see Glaxo’s stance on how they believe, despite evidence to the contrary, that their drug does not cause major withdrawal problems for those that take it.
What I find interesting is the exchange between Jofre and Benbow regarding the word ‘addiction’. Jofre, using the Oxford English Dictionary pushes Benbow on the definition of the word:
Q. Your leaflet says ‘remember you cannot become addicted to Seroxat’, but that’s not true is it?
A. Yes, it is true. There is no reliable evidence that Seroxat can cause addiction or dependence, and this has been borne out by a number of independent clinical experts, by regulatory authorities around the world, the Royal College of Psychiatrists, and a number of other groups.
Q. If people cannot stop taking a drug when they want to stop taking it they are addicted are they not?
A. No, that is not correct. The definition of addiction is not as you describe it. Addiction is characterised by a number of different criteria, which includes craving, which includes increasing the dose of the drug to get the same effect, and a number of other features, and those are not exhibited by Seroxat.
Q. That is not with respect what the Oxford English Dictionary says. It says, “Addiction is having a compulsion to take a drug, the stopping of which produces withdrawal symptoms.”
A. It is true that a number of patients will experience symptoms on withdrawal.
Q. That is what addiction means is it not?
A. No, it is not.
Q. That is what the dictionary says.
A. That is not a clinical definition of addiction or dependence. Dependence is very clearly laid down by international
Q. But when people start taking Seroxat they do not consult a medical dictionary.
A. No, and they will not consult the Oxford English Dictionary either.
Q. The Oxford English Dictionary tells you what common usage of the word addiction is. People understand that if they cannot stop taking a drug it is addictive.
A. The reality of the situation is that regulatory authorities around the world, independent clinical experts and key groups like the Royal College of Psychiatrists, have agreed that Seroxat is not habit forming or addictive.
Q. But your patient leaflet is meant to help and inform patients is it not?
A. Yes, it is, and it does I believe.
Q. Not according to the people we have spoken to who feel they were not warned that this could happen to them. They read, “You cannot become addicted to Seroxat” and thought they could stop the drug any time they wanted.
A. No, the reality is they can stop the drug, but it is true…
Q. But you cannot stop any time you want.
A. Yes, they can and the information clearly says that Seroxat is not addictive, and it is not. It is true that a proportion of patients may develop symptoms on stopping the drug. These are generally mild to moderate in nature … [Inaudible due to interruption] permitting, and will go away usually within a two-week period.
If this hasn’t angered the hundreds of thousands of sufferers world-wide yet then wait til you read the full exchange.
The way Benbow plays down the severe withdrawal issues has to be noted, they way in which he refuses to acknowledge the many thousands that have suffered horrendous side-effects at the hands of his company’s drug is also striking.
Back in 2008, Alastair Benbow instructed lawyers to contact me because I had apparently caused him ‘unwanted distress’ with a video I had created and subsequent comments to that video. I hope Benbow does not feel such unwanted distress with this file that is now in the public domain.
It’s fair to say that I do not like Benbow. I do not like the way he comes across when giving interviews on TV and his constant denials that there really isn’t a problem with Seroxat withdrawal. One only has to go to the Paxil petition to see that either over 10,000 people are lying or Benbow is…or wishes to ignore patient reports about his company’s drug.
Benbow, in effect, is calling me a liar, he is saying that I, along with thousands of others, are experiencing what is an ‘extreme reaction’ and, in truth, he and his company just don’t know why or how to help people who are suffering these severe reactions.
Only last week I highlighted how a patient had telephoned GlaxoSmithKline because she was at a loss of what to do regarding her tapering. She, just like me and many thousands, was finding it extremely difficult to wean herself off Seroxat, a drug that, claims Benbow, is not addictive. Glaxo told her to go and talk to her doctor, they refused to discuss the matter with her, citing some pharmaceutical code of practice ruling.
This is the company whose corporate motto is “Committed to improving the quality of human life.”
It’s a fascinating document, if only to show how dogged investigative reporter Shelly Jofre is and how Benbow appears to be in denial throughout the whole interview.
The document can be downloaded HERE