A quick and unashamed plug for a couple of blogs that I hope you are all regular readers of…
Seroxat Sufferers and GSK: Licence to (K)ill
I am always amazed by the sheer amount of work that Bob Fiddaman at Seroxat Sufferers puts in and if you check out GSK: Licence to (K)ill you will find one of the best set of links in the business in the Blogroll that the Truthman has put together.
I thank you.
… and guess which way he voted??
In fact the panel member in question, David Capuzzi, was one of only three experts who voted for Avandia to stay on the market with no additional warnings.
Not a conflict of interests, oh no, of course not!!??
This from Jim Edwards at BNET UK:
The news that one of the doctors on an FDA panel assessing whether GlaxoSmithKline (GSK)’s diabetes drug Avandia causes too many heart attacks failed to disclose he was a paid speaker for the company points out a giant hole in the FDA’s regulations: The disclosure form that outside experts who advise the FDA on risky drugs are required to sign only requires experts to list fees from speaking or writing for a drug company for the “Last 12 months or under negotiation.” That’s too short a time period to catch most conflicts in the drug business.
The Wall Street Journal reported that endocrinologist David Capuzzi — one of only three experts who voted for Avandia to stay on the market with no additional warnings — received $14,750 in total from GSK over the last couple of years. (His lecture topic was Lovaza, a heart drug, not Avandia.)
But if you check GSK’s payment disclosure forms back through Q2 2009 (and GSK’s admission that it paid Capuzzi $3,000 in Q2 2010 and another $8,000 before it started disclosing the payments publicly) it turns out that even if Capuzzi had filled in the FDA form correctly he only would have had to report $6,750 of his GSK income — less than half his actual financial conflict with the company.
Clearly, 12 months is too short a timeframe to accurately judge whether someone is conflicted or not. Research work sometimes takes years to complete, and publishing studies afterwards can add even more years to the process. BNET readers discovered how a too-short timeframe can cover up potential conflicts when I noted that Washington University School of Medicine’s Dr. Joan Luby, who authored a paper recommending that 3-year-olds be given antipsychotics, had failed to disclose in 2009 that she received payments from Janssen (the unit of Johnson & Johnson that markets Risperdal), or that she has given talks sponsored by AstraZeneca (maker of Seroquel), and has been a consultant for Shire (maker of Adderall XR and Vyvanse).
Some medical journals require conflict disclosures going back as far as five years. The FDA should do the same.
Related:
Avandia, once the best-selling diabetes drug in the world, is set to become a heavily restricted niche product, plastered with scary warnings, writes Matthew Herper at Forbes.com
While the majority of a panel of experts told the Food and Drug Administration that GlaxoSmithKline’s diabetes drug Avandia should remain on the market, they said it should have the most severe restrictions possible.
Several panelists blasted GlaxoSmithKline for not conducting better safety trials of its drug, forcing experts to grapple with uncertainty for two days. Many panelists said they did not trust the results of the company’s main study defending the drug and expressed exasperation at the way the company analyzed its studies. “Why isn’t there better data at this point?” said Lewis Nelson, an emergency physician at New York University Medical Center.
Remember, Glaxo has a track record of hiding negative clinical trial data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.
Read more about Seroxat here:
More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”
and here:
Let down by the MHRA… again
and here:
Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official
Back at the Avandia panel, overall, 22 of 33 panelists voted to either withdraw the drug completely or to heavily restrict its use. Seven merely wanted more warnings. Only three thought that no additional warnings were needed beyond what is already on the drug’s label.
In a long discussion period after the vote, it was clear that most panelists wanted to keep the drug around mainly for patients who can’t tolerate a rival medicine, Actos, that appears safe for the heart. “I don’t see why this drug needs to be on the market anymore,” said Morrie Schambelan, a professor of medicine at UC-San Francisco.
Many panelists had grave concerns about the main safety study that Glaxo had done to evaluate Avandia’s risk, called Record. Marvin Konstam, a veteran Tufts clinical trialist who became one of the sternest Avandia critics, said he didn’t think he could use the data from the study at all. “I’m very disturbed by the Record trial and the audit,” echoed Clifford Rosen, a diabetes expert at the Jackson Laboratory in Bar Harbor, Maine.
And this from the London Evening Standard:
GlaxoSmithKline today swallowed a £1.57 billion charge to settle legal wrangles including litigation over its blockbuster diabetes drug Avandia, after winning a reprieve over a potentially reputation-ruining safety scandal.
Britain’s biggest drugs firm said the fee would cover the “substantial majority” of settlements with Avandia patients as well as “the vast majority” of product liability lawsuits against Paxil, an anti-depressant which patients allege has links to suicidal behaviour and birth defects.
And then of course there is the soon to start action against Glaxo in the High Court in London regarding Seroxat (Paxil) and the withdrawal problems associated with it.
Ultimately Glaxo does not care – even though it settles these claims for huge sums of money, those sums are dwarfed by the profits its dangerous drugs have made over the years they have been prescribed.
It matters little to Glaxo that patients suffer and even die as a direct result of taking its dangerous drugs – after all even after all the fines and the legal settlements have been taken into account there is still a healthy profit being made.
Of course, we will never know what made Moat do it – but there are some pieces of the complex jigsaw coming to light now.
In my previous post (link) I wrote that the sister of one of Moat’s victims had said in a newspaper interview last week that “Moat had “flipped out” after being denied his regular antidepressants and steroids in prison.
Since that post I have been emailed by Mark G (many thanks) who has read the whole of Moat’s 49 page letter to the Police… and he points out this very important extract:
“I’ve slept 1 hour per night for three weeks now and am chomping my jaw like I’m on extacy [sic]. I thought it was the medication, but I’ve been off since I came out. It feels like I’m watching a film, not real at all.”
So – what do we know?
We know that Moat was on antidepressants.
We know that he experienced problems (“flipped out”) when denied his anti depressants.
We also now know that he had been off his “medication” since he left jail.
The rest is history.
I would suggest Moat was very probably suffering from severe SSRI withdrawal, having stopped his medication abruptly – and yes, I am making the presumption that the “medication” he wrote about was an SSRI…
But of course we will find out exactly what he had been taking as part of the detailed police investigation into this tragic case – won’t we?
We need to know more – we need to know the truth. Potentially, this has wide ranging implications for the treatment of millions of patients in the UK alone.
And we need to know what kind of doctor simply denies a patient his “regular antidepressants” while in prison? That surely is recipe for disaster.
WHEN ARE THE AUTHORITIES GOING TO TAKE NOTE AND INVESTIGATE THE CONNECTION BETWEEN EXTREME BEHAVIOUR, VIOLENCE AND ANTIDEPRESSANTS?
WHEN?
“…I thought it was the medication, but I’ve been off it since I came out…”
More background here and here and also at SSRI Stories.
So then – it looks like antidepressants are involved in the case of the crazed gunman, Raoul Moat.
The sister of one of his victims said “Moat had “flipped out” after being denied his regular antidepressants and steroids in prison. She said: “He’s been taking steroids as long as I’ve known him. He’s addicted and it gives him violent mood swings. He’s also on antidepressants and used to be a drug dealer, so God knows what he takes”.
WHEN ARE THE AUTHORITIES GOING TO TAKE NOTE AND INVESTIGATE THE CONNECTION BETWEEN EXTREME BEHAVIOUR, VIOLENCE AND ANTIDEPRESSANTS?
WHEN?
We have the right to ask the question and the louder Glaxo shouts about Seroxat having “no proven link to violence”, the more I want to know the truth.
As Peter Breggin wrote in an article about the Virgina Tech masssacre; “For the past fifteen years or more, I’ve been writing about the capacity of psychiatric drugs to cause mayhem, murder and suicide. In early 2005 the FDA finally issued a warning that antidepressants cause both suicidality and violence. For example, the FDA’s mandated warning label for antidepressants states that these drugs produce “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania.”
Note the reference to “irritability, hostility, aggressiveness, impulsivity” in the label or package insert for antidepressants. That’s a formula for violence. Note the mention of akathisia, another source of both violence and suicide. And finally, note the reference to mania, yet another drug-induced syndrome associated with violence and suicide.
More background here and here and also at SSRI Stories.
I came across the above named video, ‘Sara Carlin – death by Paxil’, on Bob Fiddaman’s website Seroxat Sufferers.
Bob has been following the inquest into the death of Sara Carlin. Yesterday the jury returned its findings.
In a phone conversation between Neil Carlin (Sara’s father) and Bob, Neil explained that both he and his wife “…are extremely pleased with the outcome of the inquest into our beloved Sara’s Paxil related suicide with the recommendations that the jury have given in their verdict.” He added, “The jury were under very strict restraints in their ability to name or blame any party in this inquest, including the three doctors from Oakville Ontario Canada – and the drug company GlaxoSmithKline – maker of the SSRI antidepressant Paxil.”
Neil went on, “We feel that through the breadth & depth of their 16 recommendations, the jury has carefully listened to the evidence they have heard over these past several weeks & through the quality of those recommendations have identified the root cause of Sara’s death. It is our belief if these recommendations are implemented & followed in the future, that they will surely avoid the tragic waste of young life as occurred in our Sara’s case.”
I suggest you read the rest of the post here.
And here are links to more detail on the story:
Sara Carlin Inquest – Failure of Oakville Medical Profession
Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’
Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!
Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family
Sara Carlin Inquest – Local MP Slams GlaxoSmithKline
SARA CARLIN PAXIL INQUEST VIDEO FOOTAGE
SARA CARLIN PAXIL INQUEST GLOBAL TV NEWS
SARA CARLIN INQUEST – What The Jury Should Know
Sara Carlin Inquest – “Paxil likely played important role in teen’s suicide”
Sara Carlin Inquest – The Eli Lilly ‘Links’ & Today’s Recommendations.
This from Cilla McCain writing for the Huffington Post – it’s the story of the shocking use of medication by the US military and of course features Seroxat (paxil):
While doing research for the book Murder In Baker Company, I came to know many military family members from the support group “Home of the Brave.” The group’s goal is to help one another gain information and justice in the noncombat related deaths of their loved ones. According to the Department of Defense nearly 1 out of 4 fatalities in the military are noncombat related.
Stan and Shirley White of West Virginia represent one of the “Home of the Brave” families. Three of their four children have served in the armed forces. Two have died because of their time in war. On September 26, 2005, their son Robert, an Army Staff Sergeant, was killed in a rocket attack in Afghanistan. On February 12, 2008, their youngest son, 23 year-old Marine Corporal Andrew White died in his sleep after being treated for PTSD with lethal prescription drugs.
Struggling with PTSD compounded by grief over the death of his brother, Andrew sought help from VA doctors. Their first line of defense was to prescribe him 20 mg. of Paxil, 4 mg of Klonopin and 50 mg of Seroquel. These medications helped at first, but later proved ineffective. Instead of changing the course of treatment, the doctors responded by continually increasing his dosage until the Seroquel alone reached a whopping 1600 mg per day. Within weeks of Andrew’s death, three more young West Virginia veterans died while being treated for PTSD with the same drugs, prompting Stan and Shirley White to begin a mission to find out what the deaths have in common.
“When we first learned of the other West Virginia soldiers who died in their sleep,” Stan says. “We thought it must be a reaction to biological warfare, we thought they must have been exposed to something in Iraq and now it is killing them.”
Indeed, if you conduct an internet search with the phrase “soldier found dead” the results are staggering. Narrow it down even further by including the phrase “unexplained” and you will begin to get a glimpse of what some would call an epidemic.
When the White’s received Andrew’s autopsy report, the official cause was listed as “accidental intoxication of Seroquel, Paxil, and pain medication.” Andrew had not committed suicide, nor did he take his medication in a manner it was not prescribed. Death, as it turned out, is a potential side effect of Seroquel. The doctors and the pharmaceutical company knew that, however nobody told Andrew, despite the fact that he was experiencing many of Seroquel’s most serious side effects.
In the 11-months Andrew was taking Seroquel, he gained 40 lbs., suffered from tremors, severe constipation and swelling of the mammary glands. Before his death, a VA doctor referred Andrew to an endocrinologist for tests to determine the cause of his symptoms, even though it is clearly stated in Seroquel’s literature that all of this can be caused by using the drug.
Andrew passed away before the appointment.
Dr. Fred Baughman, a neurologist and outspoken critic on the use of anti-psychotic drugs has studied the West Virginia soldier deaths and has determined that “sudden cardiac death” is the cause. In a May 2010 press release, Dr. Baughman states:
“All were diagnosed with PTSD. All seemed “normal” when they went to bed. And, all were on Seroquel (an antipsychotic) Paxil (an antidepressant) and Klonopin (a benzodiazepine). They were not comatose and unarousable — with pulse and respirations or pulse intact, responsive to CPR, surviving transport to a hospital, frequently surviving. These were sudden cardiac deaths.”
Between the VA medical doctors and psychiatrists Andrew was going to for help, none tried to assess the effectiveness of these drugs on his PTSD symptoms. They just kept increasing the dosage as if he were a guinea pig in some twisted lab experiment. Whether sudden cardiac death, polypharmacy, or suicide, a prescription tracking system could be a major step toward preventing tragedy.
To that end, in March 2010, Senator Jim Webb of Virginia called on the Surgeons General from the Department of Defense to provide data regarding prescription drugs in the military. This vital information was never received despite repeated requests, so on June 9, 2010, Senator Webb released a public statement calling on the DOD to finally adhere to the request:
Three months ago in an Armed Services hearing, Army Surgeon General Schoomaker downplayed media reports of skyrocketing prescription drug use of those serving in the Army. I am still waiting to see existing data across services and a judgment of these findings.
Webb’s statement went on to say:
A reporting requirement has been added to the FY 2011 National Defense Authorization Act requiring the DOD to keep health records that detail the prescription and administration of psychotropic medications.
There are many possible reasons why an avalanche of prescriptions are befalling our soldiers with no accountability even as those drugs kill. Financial gain by medical personnel of the DOD is one of the most serious allegations being examined and I will continue to follow this matter.
Let us hope the powers that be do not continue to stall and downplay the seriousness of this issue.
I shudder to think of how many more young, vibrant soldiers will die in their sleep in the meantime.
There’s some very interesting news at Seroxat Sufferers. Bob Fiddaman has been writing a series of posts about the identities of the expert witnesses that Glaxo are using to defend themselves against the High Court action.
It’s all a bit too cosy and I defy anyone to describe Glaxo’s experts as independent (which they should be under English law).
Anyway, last Friday afternoon Bob noticed some visits to his blog – at 16.37hrs the MHRA looked in and started read the posts about Glaxo’s ‘independent’ witnesses – then 41 seconds later, in what could only be a coincidence of the most massive proportions, you can see Glaxo’s solicitors Addleshaw Goddard, reading the exact same post.
I wonder what the chances are of that happening?
Millions to one, I’d imagine. Or maybe even billions to one….
Unless, of course, there is a connection between the two organisations and they share common interests.
I’d like Addleshaw Goddard to explain this one to me.
The posts are here, here, here and here.
Enjoy.
I’ve always questioned exactly where big pharma ends and the regulators begin.
Certainly the MHRA (the UK’s medicines watchdog) has always had VERY close ties to the drug industry, and I mean VERY close.
The revolving door that connects the MHRA and GlaxoSmithKline (in particular) has always been well used.
The Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK (then known as SmithKline Beecham), as is the Head of Licensing at the MHRA, Dr. Ian Hudson.
Breckenridge has a track record of publically supporting Seroxat (but not really very well!)… Hudson is much more interesting – he worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.
During his time at SmithKline Beecham and Glaxo he had “significant involvement” with a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.
I’ve mentioned it before, but Hudson is such an authority on Seroxat that Glaxo actually used him as one of their defence witnesses in the famous Tobin/Schell case (he gave evidence for Glaxo alongside David Wheadon). And to this day we still don’t know if Wheadon was guilty of perjury in that court.
However by 2005, Hudson was not so keen on talking…
A 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.
A prior engagement!? Hudson is the one man who knows more about Seroxat’s secrets than anyone outside of GlaxoSmithKline.
A prior engagement? – don’t make me laugh, Ian.
Now, in 2010 we see more evidence of the revolving door between the MHRA and Glaxo in the company’s choice of expert witnesses to appear in the High Court.
The tireless Bob Fiddaman at Seroxat Sufferers has discovered some very interesting facts about Glaxo’s expert witnesses.
One is Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd. Shah was employed by the MHRA between 1987 and 2004. Positions held were: Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.
I would be very interested to know 1): who are the current clients of Rashmi Shah Consultancy Ltd and 2): which company was its first client back in 2004…
I’d put money on the answers being – 1): GlaxoSmithKline and 2): GlaxoSmithKline
But this is only the start – Bob Fiddaman is promising revalations about other Glaxo ‘expert witnesses’ in the near future – keep on checking back at Seroxat Sufferers.
You want more evidence of the cosy relationship between the MHRA and Glaxo?
What happened when the MHRA found that Glaxo had hidden negative trial data?… The MHRA announced, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear.”
You want more evidence of the cosy relationship between the MHRA and Glaxo?
How about MHRA staff co-operate with Glaxo to monitor critical comment on the internet..
There’s an article in today’s Guardian about Derrick Bird’s motivation.
Police conceded last night that they might never know exactly what made Derrick Bird – a seemingly sociable, outgoing man who had just become a grandfather – shoot dead his twin brother and 11 other people, many seemingly at random, in a succession of towns and villages around west Cumbria.
Speaking to reporters late last night, Deputy Chief Constable Stuart Hyde from Cumbria police said his force would have to painstakingly piece together all the details of Bird’s life.
“That involves understanding what he has been through, his family circumstances, a whole range of things before we can make judgments,” he said. “And it may well be that we never actually find that out. But hopefully by speaking to people, looking at his history we will be able to figure out what caused this.”
The first thing I wonder, as I do whenever I hear about stories like this, is, was Derrick Bird being treated with an SSRI/SNRI such as Seroxat?
I don’t know the answer, but we have the right to ask the question and the louder Glaxo shouts about Seroxat having “no proven link to violence”, the more I want to know the truth.
As Peter Breggin wrote in an article about the Virgina Tech masssacre; “For the past fifteen years or more, I’ve been writing about the capacity of psychiatric drugs to cause mayhem, murder and suicide. In early 2005 the FDA finally issued a warning that antidepressants cause both suicidality and violence. For example, the FDA’s mandated warning label for antidepressants states that these drugs produce “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania.”
Note the reference to “irritability, hostility, aggressiveness, impulsivity” in the label or package insert for antidepressants. That’s a formula for violence. Note the mention of akathisia, another source of both violence and suicide. And finally, note the reference to mania, yet another drug-induced syndrome associated with violence and suicide.”
More background here and here and also at SSRI Stories.
