“…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