Visit these sites for all your Seroxat/Paxil information

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.

FDA Avandia panel member failed to disclose he was on Glaxo’s payroll…

… 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.

  • UPDATE: The same thing applies to Dr. Abraham Thomas, who voted to remove Avandia. He was a speaker between September 2007 and September 2008 for Takeda. If he had filled in the form correctly his conflict would not be noted because it occurred more than 12 months ago.

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:

GlaxoSmithKline – at it again, this time Avandia drug trial results “cannot be trusted”

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.

What made Raoul Moat do it…

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.

Raoul Moat flipped out when denied his regular antidepressants

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.

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