“The parents of an 18-year-old girl who committed suicide have called for better regulation of the drug she was prescribed.
Alfred and Stephanie Gatchell, from Newhaven, blame the anti-depressant Seroxat for the death of her daughter Sharise.
Now the couple, who moved to the UK from South Africa with their daughter in search of a better life, want doctors to be told not to prescribe Seroxat to people of Sharise’s age.”
“An Australian-led review of a popular anti-depressant drug has found it can tip young people into suicide and is no more effective than a placebo.
The research team also uncovered evidence that the drug’s manufacturer downplayed its deadly side-effects and exaggerated its benefits.
The study, published in the British Medical Journal, reviewed data used by pharmaceutical companies to help market the drug, which is sold in Australia under the names Aropax and Paxil. It is also known as paroxetine.
The company’s communications director, Bernadette Murdoch, told The World Today “we did provide an unprecedented level of data to the research team”.
(Sept 2015- ABC Australian News)
The restoration of GSK’s Seroxat study 329 is making head line news across the globe, and twitter has literally exploded with Seroxat/Paxil related tweets trending like wildfire. For those of us prescribed this horrific drug, this is good news, however not so much for the manufacturers GSK. So how do GSK counter such bad news? Seroxat was prescribed to millions of kids worldwide, and this study proves GSK knew it was harmful, so arguably what we are talking about here is perhaps a case of corporate manslaughter? or maybe multiple cases of corporate manslaughter and multiple attempts at corporate manslaughter? and if so, how does GSK spin an accusation of corporate manslaughter? how does their PR department spin the killing of kids from a harmful drug?
Well, they send out people like Bernadette Murdoch (The Australian GSK Communications spokesperson). Bernadette, it seems, is perhaps GSK Australia’s version of Alastair Benbow. Benbow was carted out by GSK to defend Seroxat and its link to suicide in the early 2000’s. He once said that there was ‘a small class of suicidal children’ in his estimates. We know now that the way GSK promoted Seroxat/Paxil (off label particularly) resulted in potentially many thousands of ‘small classes of suicidal children’ prescribed this drug.
Bernadette’s recent comments (on behalf of her paymasters – GSK) alarmed me a lot so I thought I would bring attention to them, and also- for the record- I’d like to correct Bernadette, because she seems to be selectively missing some very important details about this grave Seroxat situation; she also seems to underestimate the impact that the restoration of this study has had world-wide, and indeed the impact it will have for many years to come, both in academia and public discourse.
The 329 RIAT restoration team have said on numerous occasions just how difficult and overwhelming the whole process of obtaining, logging and reading the data was in this case. This is because GSK have set up a frustrating system whereby the only way to see the data is through a difficult ‘periscope’ type method. It is a miracle that the researchers had the will and tenacity to over come this (what I think is a- deliberate) obstacle, and it is a testament to their characters that they pushed ahead despite the immensely stressful difficulties presented to them. In light of this, it is therefore ironic, that Bernadette tries to spin it that GSK somehow had a difficult time presenting the data. GSK might have been slightly inconvenienced because they had to provide data from their study which was spun at the time as positive, when in fact it was negative; kids died because of this: these situations don’t equate to each other.
They might have presented an ‘unprecedented level of data’, but the way they presented it was akin to stonewalling, and anyhow so what if they provided the data? After 20 odd years on the market, surely they should have presented the data in the first place? Does Bernadette think her paymasters should be praised for presenting data which should never have been concealed to begin with? Anyhow, it was also the researchers who had the difficulties, not GSK, and those harmed by Seroxat have had more difficulties that Bernadette could ever imagine.
Furthermore, what Bernadette fails to mention is- this study was re-interpreted by the researchers because the original one is still being cited in order to justify the prescribing of Paroxetine to kids (mainly off label). Kids died because of the original study- how does Bernadette not understand how sinister this is? There is also the fact that there are many adults harmed and damaged from Paroxetine also (Bernadette doesn’t seem to concerned with this at all). Listening to someone like Bernadette, (or any of the other GSK mouth pieces) if you didn’t know much about Study 329, you would think that this is the first time the data had been analyzed, however it is precisely because GSK spun the negative data (from the first dodgy study) in the first place that the researchers were intent on correcting the record.
Kids died because GSK lied.
Many more were harmed.
Bernadette glosses over this, but I suppose that is what she is paid to do.
“It is not an easy process,” she said.
“These studies were conducted in the ’90s, many years ago when computer systems were very different. A lot of the notes were handwritten but we did provide all of the data that was requested by the team so that they could carry out the reanalysis.”
Bernadette is correct, these studies were conducted in the 90’s however that has nothing to do with the questions of manipulating the study itself in order to provide a deceptive result. Study 329 was a fraud. Kids died because of it. Bernadette doesn’t seem to see just how sick and twisted this is. The 90’s aren’t that long ago, and anyhow, Seroxat is still prescribed to children and adults, so I really don’t see her point here. GSK still profit off long term addicts. Furthermore, despite Seroxat making depressed kids more suicidal, GSK also made billions on it- so they have effectively profited by destroying lives. I don’t see how this can be spun as a positive thing…
Ms Murdoch said it was important to remember that “when a medicine is approved for use, it’s not just the pharmaceutical company that makes that decision”.
“There are lots of checks and balances in between, so a regulator uses all of the data that’s available on a medicine before recommending it for use for a patient,” she said.
Again, we see that Bernadette is trying to deflect the seriousness of this study and its affects on kids. She seems to be trying to pass the buck to the regulator. The regulators are toothless, incompetent, and useless. That’s a fact, however, GSK did the study, GSK pushed this drug on kids, it’s GSK who are ultimately responsible for destroying these kids lives. Kids died or were harmed because of this fraud. There is no avoiding this fact. Her comment about ‘checks and balances’ is utterly meaningless. When you have a drug company intent on manipulating results and hood winking the regulator, the system itself is useless. There were no checks and balances, that’s the whole point! and what little there was- was corrupted!
“In relation to the findings from the team’s analysis, they do appear to be in line with the longstanding view that these medicines, anti-depressants like paraxetine, are not suitable for children.
“This is widely known and clear warnings have been placed on the product label for more than a decade.”
Her last comment (above) really galls me. Bernadette is trying to make out that this study is old news. The warnings were put there because of Shelley Jofre’s reporting on BBC panorama’s four documentaries about Seroxat, a decade of litigation, department of justice investigations (particularly in 2004 and 2012) and much campaigning from the Seroxat users group, bloggers like me, Fid, and Seroxat secrets, David Healy’s RIAT team, and others.
This has been 14 years in the making. This is not old news!
GSK have been forced to release data, bit by bit, drip by drip, but Bernadette fails to mention any of this. She’s trying to make it seem like GSK were being transparent. This is twisting the facts.
I don’t know how she sleeps at night…
Her paycheck must help.
Maybe she should watch this documentary, it might help her understand a little more about the drug company she works for and let me remind Bernadette, the study she is defending (Aropax/Paxil/Seroxat 329), and the company she works for (GSK) deliberately misled doctors, the public and parents of children- this led to deaths of kids.
How can you reconcile that?
You just can’t defend the indefensible Bernadette.
Bernadette Murdoch, Communications Director Australasia
0449 950 745 or Bernadette.email@example.com
“It’s hard to think there wasn’t some mischief being done when a severe suicide attempt requiring hospitalization was coded as ’emotional liability,'” Jureidini said during the press call about one of the specific cases they reviewed and re-classified.
Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug.
A government probe was launched in 2002, and it was discovered that Paxil, as well as several other antidepressants, were no more effective than placebo in treating depression in kids. Indeed, between 1994 and 2001, Glaxo conducted three clinical trails of Paxil’s safety and efficacy in treating depression in patients under 18, and all three studies failed to pass muster.
One clinical trial, known as Study 329, found that teens who took the drug for depression were more likely to attempt suicide attempt than those receiving placebo pills. Glaxo hired a company to prepare a medical journal article that downplayed Paxil’s safety risks, including increased risk of suicide, and misrepresented data to trump up the positive results of the study. The article was published in 2001, falsely reporting that Paxil was an effective treatment for child depression.
Prosecutors accused Glaxo sales representatives of then using the article to promote the use of the drug for depressed youth. Sales reps invited prescribing psychiatrists to luxury resorts for “Paxil forum meetings” where they were treated to fancy dinners and free entertainment like sailing trips and balloon rides.
Reports of teens committing suicide while taking Paxil began surfacing in 2003, and the FDA discovered that 10 of the 93 Paxil patients in Study 329 had attempted suicide or thought about it, versus one out of the 87 patients on placebo. In 2004, the FDA added a black-box warning on the drug’s label about the increased risk of suicidal thoughts in teens who take it.
In October 2009:
The latest development is the approval by the European Medicines Agency (EMEA) of two flu vaccines, Pandemrix, (GlaxoSmithKline) and Focetria (Novartis). Licenses will be granted on approval by the European Commission. These are a key part of the flu strategies of governments around the world. In the UK, the government has contracts in place to supply up to 132 million doses of vaccine.
There has been some concern, however, about the speed at which the new vaccines have appeared.
GlaxoSmithKline spokesperson, Bernadette Murdoch, explained that although the vaccine is new, a lot of the work on it took place before the pandemic was declared. “We carried out clinical studies which led to the 2008 approval of the vaccine, and we are carrying out further 16 clinical studies, involving about 9,000 people and all that data will be provided to assess that. We are still going to continue to monitor its safety as we go forward.”
An international team of researchers has found evidence that the GlaxoSmithKline Pandemrix flu vaccination – which was widely distributed during the 2009 swine flu pandemic – may have caused rare cases of narcolepsy. Their study, which was published July 1 in Science Translational Medicine, described that the vaccination stimulated antibodies to attack receptors in brain cells that help regulate sleep.
Lawrence Steinman, a professor of pediatrics and of neurology and neurological sciences at the Stanford University School of Medicine, and his collaborators sought to determine why the Pandemrix vaccine
According to the study, Pandemrix, which was given to more than 30 million Europeans, strongly suggested to trigger an autoimmune reaction that led to narcolepsy in some people who are genetically at risk.
The researchers propose a “hit-and-run” mechanism where high levels of the H1N1 protein stimulate the production of large amounts of antibodies, which may remain in the blood for months, to both the virus and the hypocretin receptor. Under certain conditions, the blood-brain barrier can be altered, allowing the antibodies to enter the brain where they latch onto hypocretin receptors, possibly targeting these brain cells destruction by the immune system.
“Our study found a significant, 13.9-fold higher, risk of narcolepsy in children/adolescents vaccinated in Ireland with Pandemrix compared with unvaccinated children/adolescents,” said the researchers.
So far 31 million doses of Pandemrix have been administered in 47 countries, GSK said. It has received 335 reports as of Jul 6 of narcolepsy in people who were immunized with Pandemrix, of which 68% were from Finland and Sweden.