What I believe

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden clinical trial data that shows exactly how dangerous a drug it is.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that something must be done to help people who suffer terrible problems with withdrawal, as they desperately try to stop taking Seroxat.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Believe me – I know what I’m talking about.

RxISK – Making medicines safer for all of us

This is good.

Here’s a new website that Prof David Healy’s involved with. RxISK is a free, independent drug safety website where you can research a prescription drug to see what side effects have been reported and also share your experience and get a free RxISK Report to take to your doctor if need be.

This from RxISK:

A Good Drug is a chemical + Good Information. Most of the information on what drugs actually do is missing. Only you can provide it. Using RxISK will tell you more about the drugs you are prescribed than anything else will. By reporting to RxISK you can help make Good Drugs. Less than 5% of drug side effects are reported. Your voice has been silenced – globally.

Little is known about the effects of drugs on our hair, sex and relationships, violent and other extreme acts or thoughts, and our skin and nails, because these effects are not considered medically significant and are not tracked.

We have created the RxISK Zones with two purposes in mind:

  1. To enable you to easily search for prescription drug side effects on hair, sex, violence, suicide, and other aspects of our every day lives in the more than three million adverse drug event reports filed with the FDA since 2004, as well as our expanding RxISK database.
  2. To make it even easier for you to report these types of prescription drug side effects on RxISK.org and with your country’s drug regulator or the FDA if we don’t yet have your country’s form.

Just imagine — by reporting your experiences, you can help make RxISK the most comprehensive source of independent information on drug side effects in these important personal areas.

How it works

At the bottom of any Zone page, simply enter a prescription drug and click Continue. On the following summary page, check the box next to any side effect you are experiencing, and click the Report a drug side effect button to quickly create your personalized RxISK Report with your RxISK Score to take to your health care professional to help them help you.

The page is here if you want to add to the real world knowledge available about the drugs you take.

Seroxat litigation in the UK – important news

The High Court action against Glaxo isn’t quite over.

There were 500 litigants to start with. This number dropped to about 150.

These 150 people received a letter recently.

And today, I have been sent a copy of this email:

Hi All, If you haven’t already, please can you get in touch with Sarah-Jane Richards at Secure Law to confirm you want to continue in the action and you are happy for her to represent you.  You need to do this and previous correspondence will not count as this involves the instruction of a new law firm…we really need strength in numbers.  Please can you also confirm if you are happy for your email to be added to her list and advise if you are still taking Seroxat and if you are on benefits.

If you’ve got the letter, you’ve got the link.

Use it.

The Antidepressant Era: the movie

No apologies here, this article (and videos) have been lifted straight from David Healy’s excellent website.

It’s important that as many people as possible have the chance to read the piece and take time to watch the film.

As far as the pharmaceutical industry is concerned, I can tell you from first hand experience that the industry still believes in its own hype… do more, feel better and live longer is Glaxo’s strapline and no one in that company thinks there’s even a hint of irony in that.

Now for Dr Healy’s piece:

The Antidepressant Era: the movie

The Antidepressant Era was written in 1995, and first published in 1997. A paperback came out in 1999. It was close to universally welcomed – see reviews 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 . It was favorably received by reviewers from the pharmaceutical industry, perhaps because it made clear that this branch of medical history had not been shaped by great men or great institutions but that other players, company people, had been at least as important.

Nobody objected to it, perhaps because at this point I had not agreed to be an expert witness in a pharmaceutical induced injury case. There were likely no PR companies who had a brief to manage Healy. I knew before The Creation of Psychopharmacology came out in 2002 that the response to it would be very different.

Disease Mongering & the Myth of Lowered Serotonin

Many of the ideas in The Antidepressant Era had appeared earlier. The idea that a lowering of serotonin (chapter 5) was a marketing myth and had nothing to do with science, first appeared in my doctoral thesis in 1985, and later in Psychopharmacological Revolutions in 1987. The idea that companies market diseases as a way of marketing medicines (chapter 6) first appeared in 1990 in Notes toward a History and The Marketing of 5HT.

The Antidepressant Era in turn contained many of the elements of Pharmageddon – the key role of the 1962 amendments to the Food and Drugs Act which, through product patents, prescription-only status for new drugs and the role of clinical trials, have created modern healthcare.

Is Valium a better drug than Prozac?

In 2000 I was approached by Duncan Dallas, an independent television producer from Leeds who wanted to do something critical on the antidepressants. Prozac was still at this point widely seen as a miracle of modern medicine, rather than an inferior drug to older antidepressants. Bioethicists and social scientists were still lining up to herald the creation of the New Man through modern genetics and modern psychotropic drugs.

Saying that what we were witnessing was a triumph of modern marketing rather than modern science caused a frisson in most circles. There were no natural allies – not in psychopharmacology or biological psychiatry but not in social science circles either.

But this is what Duncan wanted. The Antidepressant Era, the movie, opens with some of the hype around SSRIs, has astonishing footage of Roland Kuhn and Alan Broadhurst, two of the key people behind the discovery of imipramine, and outlines the overthrow of the benzodiazepines and their replacement by antidepressants.

It shows how rating scales and screening are used in psychiatry to create problems for which a drug becomes the answer.  It was the first program to wheel on stage the marketing men who created the social anxiety campaigns that sold Paxil, and it outlined the role of DSM III in the creation of depression.

Duncan’s version has a wonderful artistry. The book opens with a quote from George Oppen’s The Skyscraper. The “movie” closes with the same quote.

The Building of the Skyscraper

The steelworker on the girder
Learned not to look down, and does his work
And there are words we have learned
Not to look at,
Not to look for substance
Below them. But we are on the verge
Of Vertigo.

There are words that mean nothing
But there is something to mean.
Not a declaration which is truth
But a thing
Which is ..

Oh, the tree, growing from the sidewalk -
It has a little life, sprouting
Little green buds
Into the culture of the streets.
We look back
Three hundred years and see bare land.
And suffer vertigo.

Downfall – Adolf  Who? 

Its central moment is an astonishing sequence featuring the then President of Hoffman-la-Roche, Adolf Jann, embarking on a rant that looks now like an uncanny forerunner of the famous Adolf Hitler rant in the movie Downfall. The rant that launched a thousand You-Tubes. Adolf Jahn thumps his fist on the table, voice rising, as he angrily tells an interviewer in effect “You – none of you – can do without us – just try”. See section at 20 minutes 50 seconds to 22 minutes.

There is nothing specific to Jann or Roche here. This was and is the common credo of the pharmaceutical industry. This is what the CEOs of GSK, Pfizer, Merck and Lilly are saying to governments today. Healthcare is not sustainable unless we develop drugs that get people well so they aren’t a burden on the State, and if healthcare is not sustainable democracy may not be either. Facilitate us or society as you know it goes down the drain.

It would be a mistake to see this as a horrible modern manifestation of rapacious capitalism. Socialists from George Bernard Shaw in the early twentieth century onwards have turned to biology as an answer to social problems. If we cannot get mankind to agree to change for the better, perhaps we can improve on mankind. This belief powered the efforts of governments to eliminate the unfit from the late nineteenth century through to the eugenics movement and underpins some of our hopes for the New Genetics.

Eugenics looks terrible in retrospect while modern genetics looks like our only hope – but the same impulse underpins both.  There is no better example of what good history is about than this. Anyone writing the history of eugenics should really portray its prime movers in the same light as we now portray the heroes of the the Human Genome Project.

We should always remember that the nominees for the 1937 Nobel Peace Prize included both Gandhi and Hitler. There was a time when one looked at least as likely as the other to contribute to modern civilization.

Revolution’s Little Helper

The same dynamic made Valium look like a very dark drug in 2000 – so that even its name was withdrawn. Prozac in contrast looked like the gateway to the hoped for shiny uplands of the future, when by the mid-1990s Prozac should have been seen as a far darker drug than Valium.

Valium entered a world in which psychiatry in many ways led medicine as it had done for almost a hundred years. Psychiatry was the first branch of medicine to have specialist hospitals and specialist journals. And Valium really did work remarkably well. Far from being simply a superficial treatment it likely led to the disappearance of catatonia and saved a lot of lives.

Valium probably did a lot to stimulate the Revolution of 1968. The conventional wisdom now is that Valium was Mother’s Little Helper and in this role that it played a part in the imprisonment of women in suburbia. In fact, Valium and other benzodiazepines undo conditioned avoidance. They were advertised initially as being among other things useful for salesmen – to overcome their inhibitions. They almost certainly disinhibited many women to speak out against patriarchy. They helped students breach the double-binds that Ronnie Laing and others in the 1960s were preaching were holding back society.

Prozac and the SSRIs in contrast far more often produce an apathy that is destructive to engagement in society as Who Cares in Sweden shows.  Prozac, Paxil, Zoloft, Efexor, Pristiq, and Cymbalta are far more likely to lead to suicide and murderous violence including school shootings than Valium ever did. And the SSRIs lead to just as many cases of dependence as the benzos ever did.

Tamiflu – PharMessiah?

Are we incapable of learning? Will we always be seduced by the latest PharMessiah?

The Antidepressant Era, the movie, contains an extraordinary comment on just this that no one could have foreseen when it was finished in 2001. It almost looks like the Scriptwriter in the Sky must have inserted the clip of Adolf Jahn telling us that if we don’t facilitate him and Roche society will collapse. We can only afford to keep our economy and society going if he and his company are let develop new drugs.

Well Roche got to develop Tamiflu. Where Valium was the headline drug in the 1980s for the problems a rampant pharmaceutical industry might pose, Tamiflu is now. Governments throughout the Western world stockpiled billions of dollars worth of Tamiflu on the promise that it would prevent the transmission of influenza and other viruses, and would either keep people in work or get them back to work faster, thus saving our economies huge amounts of money.

Except the drug now appears to be close to worthless and to have always been so. It seems that the impression that Tamiflu might help could only have been created because companies can hide the existence of many and in some cases most of their clinical trials and hide the data from all of them, ghostwriting the ones that are published in a manner that keeps all data out of the public domain.

Facilitate us too much and we will lead to your Downfall.

Connecticut school shooting… an antidepressant connection or not? We need to know the answer

Sadly it’s happened again. This time in an elementary school in Connecticut.

We need to understand the cause and we need to go beyond the usual US gun laws discussion…

I’ve said it before and I’ll say it again – I wonder if antidepressant medication is involved?

I’m not saying antidepressants are the cause, I’m asking for you to consider if an adverse reaction to  medication might be the catalyst for extreme, violent episodes in some patients

Why not check  medical records? Why not collect data? Why not ask the question?

Big pharma has done no research (that we know of, at least), but I know of one study and I’ve made mention of it in a previously, but given recent events in Connecticut, I think it’s worth bringing up once more.

Published on September 12, 2006, this study by David Healy, Andrew Herxheimer and David B. Menkes deals with an issue that cannot be ignored.

“Recent regulatory warnings about adverse behavioural effects of antidepressants in susceptible individuals have raised the profile of these issues with clinicians, patients, and the public. We review available clinical trial data on paroxetine and sertraline and pharmacovigilance studies of paroxetine and fluoxetine, and outline a series of medico-legal cases involving antidepressants and violence.

Both clinical trial and pharmacovigilance data point to possible links between these drugs and violent behaviours. The legal cases outlined returned a variety of verdicts that may in part have stemmed from different judicial processes. Many jurisdictions appear not to have considered the possibility that a prescription drug may induce violence.

The association of antidepressant treatment with aggression and violence reported here calls for more clinical trial and epidemiological data to be made available and for good clinical descriptions of the adverse outcomes of treatment”.

The link to the paper is here and I suggest you scroll down to the end and read the 9 cases listed in the annex.

Also worth a look is SSRI stories.

And there’s a video here, in which film maker Michael Moore discusses possible causes in another school shooting – Columbine.

Stephen Whitehead, ABPI – missing the point completely

I read this article in the New Statesman today and made me really quite annoyed…

It featured a letter written to the New Statesman by the CEO of the Association of the British Pharmaceutical Industry (ABPI), Stephen Whitehead, as a response to issues Ben Goldacre’s new book, Bad Pharma.

It’s amazing just how stupid a response it is – in fact I have to ask if Stephen has actually bothered to read the book at all or if the’s just gone into classic big Pharma knee jerk mode (after all, Stephen did spend 10 years of his career working at Glaxo and Eli Lily).

But no matter, as the New Statesman has printed Ben’s reply to the response.

However the comment I really found strange from Stephen Whitehead was this “…references to companies (GSK, Lilly, Pfizer) being fined are all examples from the US and simply not relevant to the UK market…”

GSK’s fine was, to remind you, the largest healthcare fraud settlement in history at $3bn.

How it isn’t relevant to the UK is beyond me – because what we’re talking about here is not just illegal marketing of drugs – not just bribing doctors to prescribe GSK products – what we’re talking about here are dead people.

Patients died because they were taking drugs that weren’t safe, drugs that weren’t even approved for their treatment.

In the case of Avandia, the drug is so dangerous that it can no longer be prescribed in Europe – it had to be withdrawn from the market because of high levels of heart attack, heart failure and stroke in patients. It had to be withdrawn from the market because it killed too many people.

How’s that “simply not relevant” to patients in the UK, Stephen?

Should we trust GlaxoSmithKline – and Andrew Witty…?

Trust GlaxoSmithKline?

Trust GSK? – you must be mad.

Sarah Boseley in The Guardian writes:

“The British drugs company GlaxoSmithKline is to open up the detailed data from its clinical trials to the scrutiny of scientists in a bid to help the discovery of new medicines and end the suspicions of critics that it has secrets to hide.

In a speech today [11 Oct] to the Wellcome Trust in London, the chief executive, Andrew Witty, will say openness to the public and active collaboration with scientists and firms outside GSK are essential to finding new drugs to treat the diseases plaguing the world, from novel antibiotics to cures for malaria and tuberculosis.

He told the Guardian GSK had already done much to advance transparency in clinical research, including publishing a summary of every drug trial – whether a success or not – on its website

Said Sir Mark Walport, director of the Wellcome Trust – “In its commitment towards more openness and collaboration, GSK is setting an example of how the pharmaceutical industry must adapt to help drive forward medical advances. Real breakthroughs do not come out of nowhere, but are borne of scientists sharing their knowledge and learning from each other. GSK’s moves are bold and innovative, a very positive sign of its commitment to tackle some of the greatest health challenges facing the world today.”

But hold on a minute – Dr Ben Goldacre’s not sure about GSK :

“But we should judge drug companies by their actions, not by their promises, especially when similar promises have been made in the past, and then broken.

In 1998 GlaxoWellcome promised to set up a clinical trials register, amidst outcry over withheld trial results. But when the company merged with SKB to create GSK, in 2002, this register was unceremonially deleted from the internet. This tragic story is described in an excellent open access article on this history of attempts to get access to hidden data, by Iain Chalmers.

Then, in 2003, GSK were caught withholding clinical trial data showing that their drug seroxat increases the risk of suicide in young people. As part of the settlement on fraud charges, in the US in 2004, GSK were forced to promise to post all trial results on a public website. But in 2012 GSK paid a new $3bn fine for criminal and civil fraud: this included charges over withholding data on the diabetes drug Avandia, as late as 2007, well after this earlier promise of transparency was made”.

That’s a pretty poor record, I’m sure you’ll agree.

As far as GSK is concerned, talk is cheap and promises are routinely broken with no compunction whatsoever.

 

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