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.

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.

Six and a half years on… and what has the MHRA done to clean up its act?

Nothing is the short answer.

Below are extracts from The House of Commons Select Committee Report of March 2005 on the The Influence of the Pharmaceutical Industry… March 2005 – that’s a long time ago and the UK drugs regulator, the MHRA, has still made none of the changes recommended.

The Select Committee summed up:

“The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements…. During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

The consequences of lax oversight is that the industry’s influence has expanded and a number of practices have developed which act against the public interest.”

Download the full report here, in the meantime here are a few choice extracts:

Page 4: The industry is by no means solely to blame for the difficulties we describe. The regulators and prescribers are also open to criticism.

Page 8: The industry is hugely influential ….Its influence in Parliament is extensive. The Annex lists the All-Party Groups the pharmaceutical industry supports.

Page 4: The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA’s need to compete with other European regulators for licence application business.

Page 5: The Government, like the MHRA, has tended to assume that all is for the best… In view of the failings of the MHRA, we recommend a fundamental review of the organisation

Page 30: The MHRA is unusual in being one of few European agencies where the operation of the medicines regulatory system is funded entirely by fees derived from services to industry

Page 31: The MHRA relies on company data, presented as a series of detailed assessment reports, in its decision whether or not to licence a drug. Raw data is very rarely analysed.

Page 49: The consent forms do not inform patients that the raw data may be maintained by the industry, not made available to the general public or even reviewed by the regulatory authorities.Much of the criticism was essentially of the lack of transparency and the difficulties for doctors and others in assessing the research which is undertaken.

Page 52: The major impetus for greater transparency with medicines came from a lawsuit brought in August 2004 by the New York State Attorney General against GSK, alleging the company had concealed negative clinical trial results. As part of the settlement, GSK agreed to set up a public register of all clinical trials on all of its drugs.This breached a longstanding
convention, vigorously upheld by the regulators, whereby clinical trial results
were regarded as company property and commercially confidential.

Page 52: Too many problems appear to persist unnoticed or unacknowledged by the organisations that are central to the co-ordination, conduct and review of the clinical trials.

Page 78: The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry …Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it.

Page 79: Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process.239 The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.

Page 79: Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; …The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. …Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

Page 79: Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem:

Page 82: In setting up the review of SSRI antidepressants, the MHRA/CSM responded to another long-standing concern about regulatory activity: the possible conflicts of interest of regulators.

Page 83: user reports of often serious problems had been systematically discounted or ignored.

Page 85: In evidence to this Committee, Mr Brook expressed concerns about the influence of the industry on drug regulation, specifically the perceived threat by MHRA staff of legal entanglement resulting from regulatory action: …every time we made difficult decisions there was always this issue of: ‘We have got to be very careful because the pharmaceutical companies will sue us if we get this wrong; they will take us to court and take us through legal processes’; and it was very clear that the MRHA officials were very mindful the whole time of that dimension, to my view, more than the dimension of public health and public responsibility of the public.

Page 87: Further concerns, relating to the MHRA’s reliance on company summaries of data, rather than raw data are discussed elsewhere.

Page 96: A statement to the effect that heart problems were associated with Celebrex was issued by the MHRA in December 2004. In the statement, the Agency made it clear that it had not seen the actual data from the drug company but that its advice was based on information from Pfizer’s website.

Page 98: The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.

Page 102: Thirdly, procedures for investigating complaints about breaches of regulations are too slow, poorly enforced and weakly sanctioned.

Page 103: The MHRA does not routinely examine raw data submitted with the licence application but is dependent on summaries provided by the applicant. The Expert Working Group on SSRI’s report of December 2004 showed that summaries of information may not provide the detail required to assess drug risks adequately.

Page 106: The publication of misleading promotional material is a criminal offence and the punishment should befit such a status.

Page 106: The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income… dangers of the present arrangements….During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite
competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust.

Page 117: The MHRA should put in place systematic procedures to randomly audit raw data.

SSRI prescriptions rocket by 43% in the last 4 years

Apologies for not posting for a while – the day job has been very demanding and there is a lot going on around Seroxat in the UK that I simply can’t write about yet.

However, I did notice this story a few weeks ago and it’s quite worrying as it means that Doctors are still happy to prescribe SSRIs far too freely. Given the current state of the economy, it’s a situation that may only get worse.

The figures, obtained from NHS Prescription Services under the Freedom of Information Act, cover anti-depressant prescribing from 2006 to 2010, during which time the UK had to cope with the banking crisis, recession and the start of the spending cuts.

They showed the number of prescriptions for selective serotonin re-uptake inhibitors, the most commonly prescribed group of anti-depressants, rose by 43% to nearly 23 million a year.
This is would seem to go against the Guidelines from the National Institute for Health and Clinical Excellence (Nice), that state clearly that for mild to moderate depression, pills should not be the first resort. Talking therapies work better in the long-term and there are no risky side-effects.

More on the story here at the Guardian and here at the BBC

Chuck Nemeroff – really, really pissed off… but still really, really rich!

Did I mention the textbook that Chuck Nemeroff wrote, oops – or rather he didn’t, but he might have done, or at least he might have seen some drafts and approved them… who knows?

Probably not Chuck  because his memory is so bad – maybe that’s why he forgot to disclose all that cash he got from drug companies (wasn’t it about $1.5 million?).

That’s one poor memory!

Anyway, now he’s really pissed off and wants to sue POGO because they ran a story about the ghostwritten Nemeroff textbook – and so did the the New York Times in their story: Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say

Here are some downloads for you while away the long winter hours with – thanks to 1 Boring Old Man

POGO Letter to NIH on Ghostwriting Academics
November 29, 2010 – Revised December 9, 2010
Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say
November 29, 2010
APA Statement: Psychiatric Book Not Ghostwritten
November 30, 2010
Ghostbusters at POGO
December 1, 2010
Letters from Drs. Nemeroff’s and Schatzberg’s Lawyers to POGO
December 2, 2010
NYT Corrections
December 8, 2010
POGO’s first reply to letters from Dr. Schatzberg and Dr. Nemeroff
December 8, 2010
Nature Editorial
December 8/9, 2010
Letters from Drs. Nemeroff’s and Schatzberg’s Lawyer to POGO
December 9, 2010
POGO’s second reply to letters from Dr. Schatzberg and Dr. Nemeroff
December 9, 2010

Interesting that Nemeroff thinks his reputation has been damaged by these revalations, rather than by what he has actually done in his long and chequered career.

Read more about Professor Charles Nemeroff and his links with big pharma – if the price is right he’s your man.

Taking on Glaxo in the High Court – it’s 2010 at last!

This year has been a long time coming for many people. At long last, in the Autumn, patients injured by Seroxat will be slugging it out with Glaxo in the High Court in London. The issue at the heart of this particular action claims Seroxat has a propensity to cause a withdrawal reaction.

I, for one, cannot wait – the wonderful thing about taking Glaxo on in court is all the publicity that will be generated, not to mention all the previously unseen documents that will see the light of day for the first time.

Once the court proceedings start, Glaxo will have nowhere to hide from the truth.

If you’re having trouble withdrawing from Seroxat, it’s not too late to join the High Court action – but you’ve only got a week to do it, so time is very tight.

This from solicitors Hugh James:

Have you had difficulties withdrawing from the anti-depressant drug Seroxat?

Have you found it impossible to withdraw from it? Are you having difficulties in withdrawing from Seroxat now?

The High Court made a Group Litigation Order in relation to the Group Action brought by around 500 individuals alleging harm from problems withdrawing from Seroxat.

On 19 May 2009 the High Court ordered that any individual who wishes to pursue a compensation claim must join the Group Action before 15 January 2010.

All individuals must have their claim investigated before they can join the action and so they need to come forward ASAP.

Register your interest now, call the Seroxat team at Hugh James, designated as lead solicitors for the purposes of the Group Litigation Order, on 02920 785 971 or go to http://www.hughjames.com/seroxat

The Group Register will close on 15 January 2010 and any individuals who have not joined at that date may lose their opportunity to be part of the litigation.

You should not stop taking any medication without consulting your doctor .

Download Glaxo confidential settlement agreement

Given the fact that Glaxo is currently on trial in Philadelphia (and will be in the High Court in London next year), I thought this repost might of interest to you.

Drug companies usually favour the out of court settlement – they don’t like the public scrutiny that court cases bring – not to mention the previously secret information that all too often comes to light.

But along with the settlement comes the confidentiality ‘agreement’. The message the drug companies send out is “we pay up – you shut up” – while all the while never admitting any blame (for anything).

Anyway, here’s the repost:

I’m not sure – are Glaxo admitting they’re settling Paxil (Seroxat) cases in the USA?

Well they are – this download – Glaxo settlement agreement – tells its own story, I guess. Pay particular attention to section 3 – Confidentiality of Settlement…

What I find ironic is that Glaxo, being an English company, is prepared to open its cheque book in America, but not in the UK.

So then Glaxo:

Why won’t you settle?

Why won’t you help the thousands of people in the UK who have suffered because of Seroxat?

Haven’t you made enough money from the drug?

Why are we having to slug it out with you in the High Court?

Links to the Philadelphia trial details are here, here and here.

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