The past few days has seen a flurry of news articles about the restoration of GSK’s paroxetine study 329. This new interpretation of GSK’s infamous Seroxat study in adolescents has shown that the drug can be extremely harmful. It is estimated that up to two million American kids were prescribed the drug, and back in 2002, the head of the MHRA (at the time), Alastair Breckenridge, estimated that up to 7,000 or so, kids a year, were being prescribed Seroxat in the UK.
GSK’s spokesperson at the time, Alasdair Benbow, tried to play down the risks by comparing this suicide risk to a ‘small class of suicidal children” in an average school (how large he didn’t say, but I don’t know many primary schools with 7,000 kids). I am presuming Benbow was referring to the risk of Seroxat causing suicide in the general UK population (of those under-18 on Seroxat) with his ‘small class of suicidal children’ estimate?
If so, does this really make it anymore palatable, whether it was 30 suicidal kids or 40 suicidal kids, or 100? is the number of suicidal kids from Seroxat important? or is the fact that any kids were at risk at all just totally unacceptable? This Russian roulette style game of pill prescribing with Seroxat would hardly be a comfort to any parent who had a kid on Seroxat, how would they know if it was their child who would, or maybe would not, be- in Benbow’s ‘small class of suicidal children‘.
What would have been an acceptable number of suicidal children from Seroxat?
It seems to me that while Benbow was admitting there was a risk, he was trying to make out that it was a relatively small risk therefore not that significant in the grand scheme of Seroxat prescribing and childhood depression treatment. I’m sure the parents of any child who committed suicide on Seroxat would care little for Benbow’s analogy of a ‘small class of suicidal children’. Not to get too Freudian on Benbow, but the fact that he imagined the Seroxat suicide statistics in this way speaks volumes about the way companies like GSK think about risk/benefit ratios in the public who consume their drugs. We are merely statistics to them. The ‘small class of suicidal children’ was perhaps Benbows way of understanding collateral damage. It seems that Benbow (with his psychiatrists cap on) was trying to reassure the public that it was only a ‘small class of suicidal children’ who would get these suicidal thoughts, or attempts.
So if it was a large class of suicidal children, would that have concerned Benbow at all?
Or how about a small school full of Seroxat suicides? would Benbow be alarmed by that?
Or how about a few small schools? Or a small town full of kids self harming and killing themselves on Seroxat?
Considering the amount of kids in the US who were prescribed it (two million), Benbow’s analogy doesn’t really stack up there. In fact, his analogy is a drop in the ocean when you guesstimate the numbers who were prescribed it globally (and people are still being prescribed it).
“….Paroxetine, brand Seroxat is the most prescribed antidepressant among Dutch youths.
32 000 of the approximately 40.0000 young people between 18 and 25 years,
who last year suffered from depression were prescribed the drug, usually by a psychiatrist…”
The Dutch article doesn’t say how many under-18’s were prescribed Seroxat, but it does mention that up to 32,000 young people between the ages of 18 and 25 were prescribed it for depression. The article also doesn’t mention over 25’s, or the figures for Seroxat prescribing in that age group. So how many out of this 32,000 Dutch young adults will develop suicidal thoughts, self harm, aggression or akathisia from Seroxat?
Furthermore, if two million American kids were prescribed Seroxat (called Paxil over there) and up to 7,000 British kids were prescribed it in the UK, and 32,000 young adults in the Netherlands- how many Irish kids were prescribed it? How many Spanish kids? how many Australians? New Zealanders? South Africans? etc How many kids globally? how many people globally?
Seroxat is now off patent, but the chemical – Paroxetine- is sold globally under dozens of different generic brand names (as can be seen from the image above). Is GSK warning all of these kids of the suicidal side effects? Is GSK warning all of the regulators, doctors, etc globally about the risks in kids, and in young people? or in adults?
I doubt that that are.
So if Seroxat is proven to be so harmful for kids, and GSK also admit that there are further risks of suicidal ideation in the under 25’s and under 29’s, doesn’t that indicate that it’s probable that Seroxat is a dangerous drug overall for people at any age?
In an article from 2004, the IMB (Irish Medicines Board) :
“…warned that the drug should not be used to treat anyone under the age of 18, as it appeared to increase the rate of self-harm and suicidal thoughts and behaviour in children and adolescents.
While the drug is only licensed in Ireland for use in people over the age of 18, doctors have the authority to prescribe it for younger patients if it is deemed appropriate. However this new warning will be directed at adults aged 18 – 29..”
There is a possibility of an increased risk of suicide-related behaviour in young adults aged 18 – 29. They should therefore be monitored carefully throughout treatment”, an IMB spokesperson told irishhealth.com.
When we add up the risks to under 29’s, and also the risks for all age groups, and we add this globally, what is the true extent of risks with Seroxat? how many adults are at risk? If it’s so harmful in children, then surely it’s the same in the adult populations.
I can only speak for myself, and I can honestly say that my experience of Seroxat at age 21 (3 years on the drug) was horrific beyond words. I don’t see how 21 is that much different to 18, or 17 in terms of how Seroxat would affect the body and mind. It did make me suicidal, aggressive, self harm, etc- just like the teenagers, I got the gamut of intolerable side effects. However, in the course of my blogging, and research, over the years, I have met many people over 29 who were prescribed Seroxat and it affected them in the same way. This is a drug which is toxic and dangerous no matter what age you are. GSK don’t talk about the loss of friends, self, family, income, prospects, relationships etc, or the trauma which it leaves people with. These are just as serious as the suicidal ideation that Seroxat induces. These are immeasurable, but they are very real.
In a recent post I illustrated the varied reaction from social media to the latest news about Seroxat harming kids. These reactions came from all walks of life, from all age groups, they were posted across continents, in real time on facebook and online news media. They tell of a drug causing people to shoot themselves, to lose friends, to miscarry babies, to lose their minds and their health. These stories tell of a drug which has destroyed people’s lives in so many different ways regardless of age. There are tens of thousands of Seroxat/Paxil horror stories online.
Seroxat is the mental health thalidomide. It’s not about a ‘small class of suicidal children’- it’s about mass poisoning on a global level with a dangerous, defective SSRI which never should have been licensed!
This horrible drug should be banned before anymore people get harmed.
People have been warning of the dangers for almost two decades now. See the Seroxat PIL for the litany of side effects added over the years.
Is it not time to pull this drug off the market?
Concerns over suicidal side effects for those taking paroxetine were first raised by the BBC’s Panorama programme in 2002.
Last year the Medicines and Healthcare products Regulatory Agency’s (MHRA) Committee on Safety of Medicines concluded that a modest increase in the risk of suicidal thoughts and self-harm for SSRIs could not be ruled out, but the benefits for adults outweighed the risks.
The Norwegian researchers, whose study was triggered by a journalist from the Norwegian Broadcasting Corporation working on a medical information programme, analysed the results of 16 trials involving the drug.
The studies were presented to drug regulatory agencies in 1989, prior to the drug being licensed for use by doctors in the early 1990s.
In each, patients had either been given paroxetine or a placebo (dummy pill).
The researchers carried out a statistical analysis of all the results, taking into account the length of time patients were on the drugs.
The studies included 916 patients on paroxetine and 550 patients on placebo.
There were no actual suicides in any of the studies. However, there were seven suicide attempts in the group on paroxetine, and only one in the placebo group.
Writing in BMC Medicine, the team led by Dr Ivar Aursnes, said: “Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may well be present also in adults.
“We also conclude that the recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults.”
From The Atlantic Online 09/2015:
The Human Cost of a Misleading Drug-Safety Study
A reexamination of old data for Paxil found that the antidepressant is more dangerous than the authors let on. How much harm has been done in the 14 years since it was published?
Rodrigo Paredes /
David Dobbs 2:53 PM ET
Sara Bostock once sent me a picture of her and her daughter Cecily in happier times, and it’s a happy shot indeed: Mother and daughter, 40-something and 20-something, outdoors in the sun, looking radiant. With their beaming smiles—the same smile, really, for they look so alike—they appear thrilled to be mother and daughter.
One night in 2002, a couple years after that photo was taken, Sara woke in the night thinking she’d heard a bump in her kitchen. When she went to investigate, she found her 25-year-old daughter on the kitchen floor in a pool of blood. Next to Cecily on the floor was a large and bloody chef’s knife. In her chest were two knife wounds. One was shallow; the other was fatally deep.
Sara Bostock has always thought that her daughter was killed that night by an antidepressant called Paxil. Cecily, a bright, generally cheerful Stanford graduate, had been taking Paxil for two weeks. Five months before, she had become moderately depressed, and, as Sara would recall it, entered a psychiatric system newly enamored of chemical models of depression and chemical solutions. In search of the drug that would work well, doctors had put her on one after another that worked badly. Of these, Sara says, Paxil was the worst. It made Cecily more and more agitated, increasingly unlike herself. Finally she ended it in what Bostock has called a death “completely unexpected, out of character and violent.”
Cecily’s doctor was hardly alone in prescribing Paxil that year. A year before, in 2001, a much-publicized paper described a clinical trial that showed Paxil to be safe and effective in teenagers as well as adults. Study 329, as it became known, helped spur a huge increase in Paxil prescriptions. In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults. (As a 25-year-old, Cecily Bostock was, from a neurophysiological perspective, on the cusp between adolescence and adulthood.) Did Cecily’s psychiatrist choose Paxil because of Study 329? It’s hard to believe the answer is not at least partly yes.
The study is now again in the news, as a new reanalysis of the its original data—including about 77,000 pages of formerly inaccessible patient records—shows that Paxil was neither effective nor safe. The reanalysis, published in the scientific journal BMJ, found that the study, underwritten by the drug’s maker, GlaxoSmithKline (or GSK), created a false picture of safety partly by misclassifying suicidal acts (such as taking 80 Tylenol) as less-alarming behavior or side effects. Other researchers who have looked at Study 329’s data have concluded likewise.
Virtually everyone involved in Study 329 has either declined to comment or insisted the study is sound.
Count this as shocking but unsurprising, for GSK has been admonished and fined many times since 2001, including once for $3 billion, for exaggerating Paxil’s safety and marketing it improperly for use in adolescents. 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. This illustrates why they want to do so: It appears to be a direct demonstration of how a company and researchers can misinterpret the data to make a bad drug look good.
Benedict Carey covers this story well in yesterday’s New York Times, though I disagree with his assertion that this reexamination of original data is something novel. Reexamining important data is part of science. It was delayed here, as it has been for most drug-trial studies, because drug companies are often allowed to keep their raw data secret. Even when outside researchers can get to the data —and it’s a wonder they managed to do so in this case—it’s both hard to find money for independent examination and hard to conduct that examination well. The BMJ study happened because of a special program called RIAT (for restoring invisible and abandoned trials) to spearhead such efforts.
Perhaps the most essential read, aside from the study itself, is the BMJ’s feature examining the study’s history. The article is deeply reported, sad, riveting, and damning. It condemns not just the company and the original study but an entire ecosystem of researchers, journals, and universities that have resisted the sort of correction the BMJ paper seems to offer. The most chilling part is that even though GlaxoSmithKline has been found to have acted questionably again and again in its promotion of Paxil, many of the institutions and researchers involved in the study and subsequent promotion of the product have remained unapologetic and are silent or unresponsive to efforts to have the original paper retracted or the record otherwise corrected.
At one point the article describes the increasing pressure put on Andrés Martin, a Yale professor and the current editor of the journal that published the 2001 study, to retract the paper. Martin has repeatedly stood his ground, stating in 2012, after GSK was fined $3 billion, that his inquiries had found “no basis for editorial action against the article.” Ivan Orasnky, the cofounder of the Retraction Watch blog, told the BMJ that Martin’s silence is straight from the “typical scientific playbook.” The universities whose researchers authored the original 2001 study, including Yale and Brown, have similarly refused to censure the paper or publish any open inquiries into its making. Virtually everyone involved in producing Study 329 has either declined to comment or insisted the original study is sound.
As Carey notes in his Times story, thousands of children, teens, and young adults attempted or committed suicide while on Paxil—but it’s impossible to know how many, if any, did so because of Paxil. This new BMJ paper makes it seem more likely than ever than some did. And of her daughter, Sara Bostock has no doubt.
When I first wrote about the controversies over use of SSRI’s in teens, a decade ago, a psychiatrist and journal editor critical of the practice told me, “If a drug company’s sales representative’s lips are moving, he’s lying.” It was meant as hyperbole—and it was damned good hyperbole. The current silence of the journals and institutions involved with Paxil’s long promotion reminds us that sealed lips can be just as deadly to the truth.