Interestingly, I’ve just found this old article from the BMJ, 29 January 2005

Select committee angry over absence of drug regulator from session

London – by Lynn Eaton

Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry.

Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division.

MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.

Committee members were told that Dr Hudson could not attend the session because he was at a London meeting as a representative of the Committee for Medicinal Products for Human Use, a part of the European Medicines Evaluation Agency.

“It would have been useful if Dr Hudson had been here, as he was at SmithKline Beecham and his department was responsible [for drug safety],” said Mr John Austin (Labour MP for Erith and Thamesmead).

The agency’s chairman, Alasdair Breckenridge, told MPs he had been a member of the scientific committee of SmithKline Beecham from 1992 to 1997, when he resigned. He fiercely defended his involvement with the committee and denied any knowledge of the issue of the safety and efficacy of paroxetine.

The agency’s chief executive, Kent Woods, also giving evidence to the committee, said that Dr Hudson had assured him he had no direct personal involvement in this safety issue. “However, because of his role in the company [SmithKline Beecham] he doesn’t get involved [in discussions on Seroxat],” said Professor Woods.

Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend.

However, Professor Woods, also speaking afterwards, said that some discussion with the committee secretariat about who would attend had taken place and that the agency had received a clear statement from the committee about whom it wanted to see, which did not include Dr Hudson.

Professor Woods and Professor Breckenridge also sought to reassure the committee that measures were now being taken by the agency to monitor new drugs more closely. Both reiterated the views of earlier witnesses that the public needed a better understanding of the risks and benefits of all drugs.

Professor Breckenridge admitted that the agency had “suffered from not being professional enough” in its communications. “We are determined to change that,” he said, explaining that the agency has just appointed a communications director.
I hope you noticed the paragraph in bold – “Speaking after the meeting, the committee’s chairman, David Hinchliffe, who was clearly angry at the committee’s inability to question Dr Hudson, said his understanding was that Dr Hudson was invited to attend”.

But what I find strange is that if you want to download this PDF - Witnesses for Thursday.pdf – you’ll see that it appears that Lord Warner (then Health Minister) and David Hincliffe had a phone conversation on the Monday morning before the hearing and agreed exactly who was going to attend from the MHRA… and you will see that Ian Hudson is not mentioned as a witness.

I’m confused – who’s lying then – Lord Warner or David Hinchliffe? and why?

I have emailed my concerns to members of the Committee who were there, asking questions that day, but so far I have been ignored – more than once…

Below is an old post I wrote, specifically about Ian Hudson and the way he avoided giving evidence to the House of Commons select committee – he just didn’t bother to turn up – he said he had a ‘prior engagement’.

How very convenient.

A short while ago, I wrote a post about Dr Ian Hudson. Hudson is currently the MHRA’s Director of Licensing – but the job he had before he joined the agency was at GlaxoSmithKline – he was their Worldwide Director of Safety and we know from his CV that one of the drugs he had “significant involvement with” was, in fact, Seroxat…

In my previous post I bemoaned the fact that Hudson had decided to go elsewhere on the day he was expected to be questioned by the House of Commons Health Select Committee about Seroxat safety and trial data.

The MHRA has been questioned about the secret data that Glaxo kept hidden for more than a decade.

The MHRA replied that they were “confident that neither Professor Breckenridge nor Dr Hudson had prior knowledge of the data discussed in Dr Breggin’s report.”

Does the MHRA really expect us to believe that Glaxo’s Worldwide Director of Safety, who had a “significant involvement in Paroxetine” (Seroxat), did not have full knowledge of ALL the trials and data that appertained to this particular drug?

Does Ian Hudson expect us to believe this?

He was their Worldwide Director of Safety and Seroxat is one of GSK’s biggest ever blockbuster drugs… hmmmm?

This stinks.

Over the years I have followed the work of MHRA (collected posts are here) and I have to say the organisation is useless. It protects nothing but the interests of the pharmaceutical industry. That’s not surprising since the pharmaceutical industry completely funds the licencing and regulation work and many ex big pharma employees now work at the MHRA in very senior positions (Ian Hudson take a bow).

This recent story from the Daily Mail here in England sums up years of MHRA failures.

Faulty implants, dodgy drugs and a toothless watchdog that’s failing patients
By John Naish

Just over two years ago consultant plastic surgeon Azhar Aslam became deeply worried — he’d had to remove eight silicone breast implants from women within a few months of each other because they had ruptured prematurely.

It struck him as highly unusual.

‘If implants do rupture, it is normally after seven to ten years, and it is usually caused by an impact, such as the wearer falling over or having a car accident,’ he says.

‘But these implants had failed after only two to three years, and the patients had not been involved in any impact.’

All the implants were made by the French firm Poly Implant Prothese (PIP).

Mr Aslam, previously an adviser to the European Academy for Cosmetic Surgery, sent some of the ruptured implants back to the manufacturer but was not satisfied with their explanation.

So on July 9, 2010, he wrote to Britain’s medical safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA) which regulates and had approved the use of PIP implants.

He alerted Dr Susanne Ludgate, the medical director of devices, to the problem, offering to supply samples of the faulty implants.

Five days later, he received an email saying she’d passed his warning to the agency’s Adverse Incident Centre and they would be in touch.

But he heard not a squeak. ‘No one from the Adverse Incident Centre has ever contacted me. Perhaps they were busy or something,’ he says.

Or perhaps the watchdog was asleep.

For as we now know, more than 40,000 British women have been given these faulty implants.

Behind the furore over whether they should now have their implants removed — and who should pay for it — there is disquiet about the MHRA’s role.

Officially the agency is ‘responsible for ensuring that medicines and medical devices work, and are acceptably safe’. It not only approves these devices and drugs, but regulates them.

The agency’s initial response to fears over the implants was to say the failure rate was only 1 per cent.

Then, last week, the MHRA admitted the safety of breast implants was actually impossible for it to judge, because an accurate record of the number of procedures has not been kept.

Clinics were blamed for this failing, with Health Secretary Andrew Lansley criticising them for providing ‘poor quality’ data.

Mr Aslam lays the blame elsewhere.

‘We rely on the regulatory authorities to ensure our implants are OK,’ he says.

‘And when we try to tell them that something is wrong with the safety-approved implants, these authorities do not seem to take any proper notice. It leaves me asking, “Who can I trust?” ’

Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually.

In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.

Evidence against Avandia had been building since 2007.

And, while denying it had failed to reveal the risks when they showed up, in July 2010 the drug’s maker, GlaxoSmithKline, reportedly paid out £304 million in damages to settle about 10,000 patient lawsuits in the U.S.

However, in the same month an advisory body to the MHRA warned it that the ‘risks (of Avandia) outweigh its benefits, that it no longer has a place on the UK market’ and called for prompt action.

The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities.

A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat.

Specialists had been warning for years of the raised risk of suicide in children. But the MHRA, relying on evidence from the manufacturer, issued assurances that there was no suicide link.

Then, in 2003, following two BBC Panorama programmes, the drug watchdog mounted its own investigation and discovered the manufacturer had hidden information about the suicide link.

After this, the MHRA said it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse’.

The watchdog was not only asleep, it was toothless.

Similar problems arose with the arthritis painkiller Vioxx. This was withdrawn from the market in the UK four years ago, but only after a 2004 U.S. study found it doubled the risk of heart disease. Leading cardiologists had been flagging up the risks for years.

After Vioxx’s withdrawal it emerged that data from clinical trials had been ‘fudged’.

The MHRA launched an investigation into whether its maker, Merck, had correctly reported the side-effects of Vioxx to the authorities.

But government prosecutors decided that there was no realistic prospect of a conviction in this case.

The MHRA says the UK laws requiring disclosure of negative drug trial results have since been tightened. No companies have been prosecuted since then.

Yet it’s not just the agency’s supervision of drugs that raises concerns, but medical devices, too.

These include crucial items such as heart pacemakers.

Last May, the British Medical Journal (BMJ) said not enough was being done to check the safety of medical implants.

It says that in 2009 the MHRA received more than 9,000 reports of ‘adverse incidents’ involving medical devices.

More than 1,880 of these involved serious injury and 202 resulted in death. In one case, a patient’s combined pacemaker/defibrillator misfired more than 30 times in one day, delivering huge jolts of 750 volts direct to his heart.

The BMJ has said our regulators are not ‘fit for purpose’ because of their failure to act in patients’ interests.

It is these sorts of problems that have led experts such as Andrew Herxheimer to call for the MHRA to be subjected to ‘root and branch reform’.

Dr Herxheimer is an emeritus fellow of the UK Cochrane Centre and a world leader in examining clinical trials to see how well therapies work.

One problem, says Herxheimer, is that the agency’s role is shrouded in confusion.

‘Its job description has not been defined,’ he says.

‘In fact, it seems to be acting as a rather secretive negotiating agency between the government and the pharmaceutical industry.

‘It is certainly too close to the pharmaceutical industry,’ adds Herxheimer.

‘There appears to be a revolving door with people who have previously worked in the pharmaceutical industry coming to work inside the MHRA. ’

Accusations have long been made that the watchdog is too close to industrial interests, notably when Ian Hudson, who was worldwide safety director of GlaxoSmithKline until 2001, became director of licensing at the MHRA.

Nor have the agency’s actions helped assuage these kinds of concerns.

Six years ago it had to apologise for misleading the public over the results of a consultation exercise with the medical royal colleges.

It claimed they were in favour of letting a powerful heart drug be sold by High Street chemists without a prescription.

In fact, an investigation by medical journal Drugs and Therapeutics Bulletin found the drug, a statin which can help lower cholesterol, had effectively been rejected by two-thirds of the expert bodies consulted because of fears over side-effects. 

The MHRA apologised and said it had made an ‘administrative error’.

‘This has got to be the killer argument for a massive overhaul of the MHRA,’ said Dr Ike Iheanacho, the journal’s editor.

‘This latest episode totally undermines faith in their decision-making process.’

MPs have also been worried by the agency’s behaviour. In 2005, a highly critical report by the Commons health select committee objected to a lack of openness and the MHRA’s closeness to the pharmaceutical industry.

It warned that scandals on the scale of Vioxx would happen again because the regulators were not sufficiently independent.

In response, the agency said: ‘Since November 2005 all staff and immediate members of their families are not allowed to have any financial or other interests in the pharmaceutical industry.’

But for Paul Flynn, Labour MP for Newport West, this does not go far enough. The problem, he suggests, is that the MHRA is ‘an organisation whose activities are entirely financed by a levy from the pharmaceutical industry’.

A key figure on the health select committee, he remains adamant the MHRA must be reformed or replaced with a more robust body.

As the arguments rage over this issue, breast implant surgeons such as Azhar Aslam and their patients are left stuck in the middle — unsure of who to trust for independent advice.

‘I would like to see the regulations tightened up,’ he says. ‘Otherwise how can I guarantee to women that the implants I am giving them are safe?’

The MHRA says it did respond to Mr Aslam. Mr Aslam and his clinic, the Linia Cosmetic Surgery in London, are adamant that they never received any such response.

[Might I suggest the MHRA publishes a copy if its response to Mr Aslam]

The DSM is published by the American Psychiatric Association and provides a common language and standard criteria for the classification of mental disorders. It is used in the United States of America and in varying degrees around the world, by clinicians, researchers, psychiatric drug regulation agencies, health insurance companies, pharmaceutical companies, and policy makers. There have been five revisions since it was first published in 1952, gradually including more mental disorders, although some have been removed and are no longer considered to be mental disorders, most notably homosexuality.

In 1952, the manual was 130 pages long and listed 106 mental disorders… by 1994, DSM-IV was listing 297 disorders in 886 pages.

It has been alleged that the way the categories of the DSM are structured, as well as the substantial expansion of the number of categories, are representative of an increasing medicalisation of human nature, which may be attributed to disease mongering by pharmaceutical companies and psychiatrists, whose influence has dramatically grown in recent decades. Of the authors who selected and defined the DSM-IV psychiatric disorders, roughly half had had financial relationships with the pharmaceutical industry at one time, raising the prospect of a direct conflict of interest.

In the past, I have written about the DSM and I’m not a fan of what I consider to be a deeply flawed publication, whose main reason to exist seems to be to enable drug companies to sell more drugs for newly diagnosed ‘disorders’. It’s just another part of the modern marketing mix.

But I had better be careful what I write, as the APA jealously guards its property – see here.

And the APA itself isn’t really whiter than white – In 2008 it became a focus of congressional investigations regarding the way that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions.

The drug industry accounted in 2006 for about 30 percent of the association’s $62.5 million in financing, half through drug advertisements in its journals and meeting exhibits, and the other half sponsoring fellowships, conferences and industry symposiums at its annual meeting.

A recent APA president, Alan Schatzberg, came under fire after it came to light that he was principal investigator on a federal study into a drug being developed by Corcept Therapeutics, a company Schatzberg had himself set up and in which he had several millions of dollars’ worth of stock.

It’s all just a little bit too cosy, I reckon.

Anti-depressant ‘relieves hot flushes in more than half of menopausal women’ Venlafaxine improved flushing in over 60 per cent of patients. However, it is known to cause withdrawal symptoms.

And the research was funded by a charity (adds credibility):

Wellbeing of Women, a charity which funded the study, hopes the findings could lead to new treatments for the problem, offering an alternative to Hormone Replacement Therapy (HRT).

HRT was found to be the most effective treatment, with 75 per cent noting an improvement, while venlafaxine improved flushing in over 60 per cent of patients – with the majority of those prescribed it wishing to continue with the drug. Clonidine only worked in 40 per cent of the women.

Interesting story, very positive without going over the top – Pfizer, the company that manufactures Venlafaxine must be pleased; this research could be the first step to opening up a huge new market for its drug (withdrawal symptoms aside of course).

I just can’t help wanting to dig a little deeper though… and I wonder if there might be some conflicts of interest floating just below the surface.

It seems that Wellbeing of Women numbers Pfizer amongst its corporate funders – you know, the same Pfizer that makes Venlafaxine, the drug that did so well in the new research funded by Wellbeing of Women, which is part funded by Pfizer…etc etc

I have a couple of questions – HRT v. a Pfizer antidepressant v. a blood pressure tablet – I wonder how the drugs on trial were chosen – and I wonder how well the placebo group performed?

Could there be a conflict of interest here? I’m sure there isn’t, but this ‘news item’ throws up a number of issues.

Over to you Wellbeing of Women…

[Read more here about the ways in which drug companies have used 'charities' to market their products under the guise of honest research].

This story from today’s Independent – interesting, as it exactly parallels the anti-depressant story all too many of us recognise.

Doctors in denial? – surely not…

Doctors are being sued for creating prescription drug addicts amid claims they have failed to follow safety guidelines published more than 20 years ago.

I was looking forward to reading something that I thought would bring healthcare professionals up to date on the dangers of SSRIs and so position the MHRA firmly on the side of patients.

In reality the learning module reads like something a pharmaceutical company would write – you know, like a more detailed Patient Information Leaflet (the leaflet you get in the box with your tablets). Nothing wrong with that I suppose, except from my experience, the PIL really played down the many strange side effects and horrible withdrawal I endured for almost two years – and as it was written by a drug company – about one of its own products – you would hardly expect otherwise.

An interesting point about the Seroxat PIL, for example, is the way it has ‘developed’ over the years – as GSK has been unable to hide the truth from the public over the years, so it has had to rewrite the PIL – have a look at all the different versions here and compare the very first one with more recent versions.

Blockbuster drugs earn pharmaceutical companies billions and billions in pure profit and so the ‘reputation’ of a drug is carefully built and jealously protected.

The truth doesn’t get a look in.

This can also be true of the clinical trials that the drug companies use to get their licences in the first place – perhaps you didn’t know that the drug trials that don’t produce the ‘right’ results (ie positive) for a drug are simply hidden or the trial is abandoned.

Bad results are buried, as there is no law that says drug companies have to submit the data from ALL the trials they undertook. However some trials are needed to submit with licence applications, so sometimes, as in the case of study 329 for Seroxat, the trial is published but the results are misinterpreted in a way that show the drug, Seroxat in this case, to be safe and very effective, when the opposite was actually true.

Anyway, back to the learning module. As I said it reads like something a pharmaceutical company would have written… And then I noticed this line “…This learning module is derived largely from summaries of product characteristics (which, in turn, are based on rigorous evaluation of submitted evidence)….”

And you know who writes the “…summaries of product characteristics…” don’t you?

And you know who submits the evidence [always positive], don’t you?

And you know who undertakes the rigorous evaluation, don’t you?

I think you may have got there ahead of me – the summaries of product characteristics are written by the Marketing Authorisation Holders, who just happen to be… The drug companies… that make the drugs – that rig the trials – that write the PILs – that hide the negative data – that make the billions.

The truth doesn’t get a look in.

It strikes me there are a couple of points coming out of this story:

1 – it seems if you have enough money you can buy your way out of trouble… even if that ‘trouble’ is criminal.

2 – Andrew Witty thinks he’s changed Glaxo – he said “…This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today…”

Well Andrew, this deal is in the US – what about the UK?

You’re not quite so happy for the new, improved GlaxoSmithKline to settle claims in the UK are you, now Andrew.

Could it be because you know the UK legal system works in your favour, so you can effectively ignore UK cases… in the UK cases like this are not heard in front of a jury, but in front of a high court judge – and funding is not easy to get. Basically in the UK we have no real chance to take on big business and patients not protected by the MHRA.

It’s different in America: this from the New York Times By DUFF WILSON

The British drug company GlaxoSmithKline said Thursday that it had agreed to pay $3 billion to settle United States government civil and criminal investigations into its sales practices for numerous drugs.

The settlement would be the largest yet in a wave of federal cases against pharmaceutical companies accused of illegal marketing, surpassing the previous record of $2.3 billion paid by Pfizer in 2009. In recent years, drug companies have been prime targets of federal fraud investigations, which have recovered tens of billions of dollars for Medicaid and Medicare.

The cases against GlaxoSmithKline include illegal marketing of Avandia, a diabetes drug that was severely restricted last year after it was linked to heart risks. Federal prosecutors said the company had paid doctors and manipulated medical research to promote the drug.

GlaxoSmithKline had already set aside cash for the settlement, which analysts said would remove legal uncertainty. The company’s stock rose 2.96 percent Thursday, to $44.55, near its 52-week high, amid a broader market advance of about 2 percent.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” Andrew Witty, chief executive of GlaxoSmithKline, said in a statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”

The agreement to settle its biggest federal cases should be completed next year, the company added in the statement. It said $3 billion would settle not only the Avandia case, but also a Justice Department investigation of its Medicaid pricing practices and a nationwide investigation led by the United States attorneys in Colorado and Massachusetts into the sales and marketing of nine of its drugs from 1997 to 2004.

GlaxoSmithKline did not specify how much money would resolve each case, nor the possibility of criminal findings and fines, saying the final settlement remained under negotiation. A Justice Department spokesman declined to comment.

GlaxoSmithKline, with a market value of more than $110 billion, had net profit of about $5 billion on sales of $43 billion in the year ending Sept. 30.

The company set aside $3.4 billion in January — eliminating its fourth-quarter profit — and $2.3 billion in July 2010 to resolve a variety of civil and criminal cases.

Critics of the settlements made with drug companies argued for stiffer penalties, including prison sentences for corporate officials.

Frances H. Miller, a Boston University law professor and health policy expert, said, “Although $3 billion is a very big number in terms of drug industry settlements, it’s not a very big number in relation to almost $50 billion in annual revenue for the world’s fourth-largest pharmaceutical company.”

Patrick Burns, spokesman for Taxpayers Against Fraud, an advocacy group for whistle-blowers, said, “Who at Glaxo is going to jail as a part of this settlement? Who in management is being excluded from doing future business with the U.S. government?”

Last year, the Justice Department accused a former vice president and associate general counsel of GlaxoSmithKline, Lauren C. Stevens, of obstruction of justice and making false statements. But she was acquitted of all six charges in May by a United States District Court judge, Roger W. Titus, in Maryland, who ruled that she had been advising the company in good faith.

Mr. Burns said the health care sector accounted for more than 80 percent of the $4 billion in overpayments recovered by the government in 2010 as a result of whistle-blower lawsuits and resulting fraud investigations by federal and state agencies.

“This is a well-worn path for big pharma,” said Les Funtleyder, health care strategist with the New York brokerage firm Miller Tabak.

“I know $3 billion sounds like an astronomical number,” he added, “but when you live in the world of worst-case scenarios, like investors do, $3 billion is a welcome relief. At least you have certainty.”

Brian Bourdot, an analyst at the investment bank Barclays Capital, called the settlement an important step but also noted that GlaxoSmithKline “remains involved in other legal disputes, including alleged violations of the Foreign Corrupt Practices Act.”

“We regard such disputes as an innate risk for large multinational pharmaceutical companies,” he wrote in a note to investors.

In a separate case last year, GlaxoSmithKline agreed to pay $750 million, including a $150 million criminal penalty, to resolve federal complaints about manufacturing quality at a plant in Cidra, P.R., since closed.

Mary Anne Rhyne, a spokeswoman for the company, said Thursday that it was still negotiating with the government over whether to include a corporate integrity agreement in that deal. The agreement could provide further penalties for other violations, though in manufacturing.

If you follow this argument to source, then you have to question the drug companies about the way they run their drug trials and the way the way they market their (all too often) sub-standard and dangerous drugs – Glaxo, amongst many others, 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.

This from today’s Independent:

What if the drugs don’t work?

Research repeatedly shows that antidepressants give little benefit – but serious side effects. Yet millions who take them regard them as lifesavers. Markie Robson-Scott reports on the controversy that is dividing psychiatrists.

When my American friend Bill, who’d been on SSRI antidepressants for 22 years (Prozac, followed by Paxil, Lexapro, then Celexa), read a two-part article by Dr Marcia Angell in The New York Review of Books recently about the crisis in psychiatry and the inefficacy of antidepressants, he stopped taking his meds (tapering off gradually, monitored by his doctor). “The article brought on enough doubt to push me over,” he said. Since then, his moods have become more volatile – more anger, more emotion, such as crying at the end of the last Harry Potter film (he’s in his 50s). But he’s got his libido back after years of “muffled response” and that seems a worthwhile trade-off.

Instead of listening to Prozac, have we been listening to placebo all along? Research repeatedly appears to show that: antidepressants are little more than placebos, with very little therapeutic benefit but serious side-effects (70 per cent of people on Celexa and Paxil report sexual dysfunction, and in some, it carries on even when they stop taking the pills). The theory of chemical imbalance as a cause of depression is an unproven hypothesis; and doctors are prescribing the drugs mainly because of the “juggernaut of pharmaceutical promotion”, as the US psychiatrist Dr Daniel Carlat calls it.

It’s not surprising there’s a US media furore – about 10 per cent of Americans over the age of six take antidepressants. In the UK, prescriptions for the drugs went up 43 per cent in the last four years to 23 million a year.

Professor Irving Kirsch, associate director of the programme in placebo studies at Harvard Medical School and author of The Emperor’s New Drugs: Exploding the Antidepressant Myth, says the theory of chemical imbalance – that there is not enough serotonin, norepinephrine and/or dopamine in the brain synapses of depressed people – doesn’t fit the data (lowering serotonin levels in healthy patients has no impact on their moods). Chemical imbalance is a myth, he says. It follows that the idea that “antidepressants can cure depression chemically is simply wrong”. His meta-analysis of 38 clinical studies – 40 per cent of which had been withheld from publication because drug companies didn’t like the results – involving more than 3,000 depressed patients on SSRIs shows that only 25 per cent of the benefit of antidepressant treatment was due to the drugs and that 50 per cent was a placebo effect. “In other words, the placebo effect was twice as large as the drug effect,” though the placebo response was lower in the severely depressed.

This is not quite as damning as it sounds: placebos are extraordinarily powerful and can be “as strong as potent medications”. Placebo response is specific: placebo morphine eases pain, placebo antidepressants relieve depression. It’s a question of expectancy and conditioning: if you expect to feel better, you will, even if you’re getting negative side effects, because side effects, Kirsch says, convince people that they’ve been given a potent drug.

Psychotherapy boosts the placebo effect and is “significantly more effective than medication” for all levels of depression, he says. Antidepressants should only be used “as a last resort and only for the most severely depressed”.

Of course, not everyone agrees. Ian Anderson, Professor at psychiatry at the University of Manchester, who is to debate whether “antidepressants are useful in the treatment of depression” with Kirsch at a conference in Turkey next month, thinks we’re in danger of throwing the baby out with the bathwater when we say antidepressants are rubbish. Antidepressants are part of a doctor’s toolbox, though probably most useful for the most depressed; some people don’t take to talking therapies; it’s not an either/or situation, he says.

Professor Allan Young, chair of psychiatry at Imperial College London, agrees. “Depression is such a huge category of illness – there are multiple types, and each type responds differently.” Of course, the brain and the body are inextricably linked, he says, and placebo effects are greater in the less-severely ill.

To make things more complicated, there’s the nocebo effect. If you expect to feel bad when you come off antidepressants, you will, because “we tend to notice random small negative changes and interpret them as evidence that we are in fact getting worse”, Kirsch says.

Lucy, who was suicidal, took Cipramil (Celexa in the US) on and off for 10 years. She says the drug “gave me back myself, it was like a ray of light shining through fog”, but the side effects – nausea and lost libido among others – forced her off it. Then “it was like a clock ticking, a twitch in the back of my mind. I lived in fear of the depression coming back. The only thing that kept me alive was knowing the pills were there. But was it because I believed I was a depressive so when I had the negative feelings I panicked?”

For Judy, lofepramine, a tricyclic, worked well. “First I was given Prozac, which gave me huge anxiety, like a bad trip, and made me horribly aware of all my nerve-endings. But lofepramine worked from the first day. When I took it in the morning I’d get a chemical lift, like a switch being turned on: it was a fabulous rush of joy.”

She stopped taking it after six months. Several months later, she felt low, though not depressed – “I feel depression like a stone in my solar plexus, and it wasn’t like that. But still I thought it would be nice to have that short-cut to happiness, so I took a lofepramine and it had no effect whatsoever – because I wasn’t really depressed. So to me the placebo theory makes no sense.” Neither does it to Hannah, who took Prozac for 10 years and says “it was absolutely fantastic and saved my life”.

Daniel Carlat, a psychiatrist in Boston and author of Unhinged: The Trouble with Psychiatry – A Doctor’s Revelations about a Profession in Crisis says that prescribing is a hit-and-miss affair. “Unfortunately we know a good bit less about what we are doing than you might think,” he writes. “When I find myself using phrases like ‘chemical imbalance’ and ‘serotonin deficiency’, it is usually because I’m trying to convince a reluctant patient to take a medication. Using these words makes their illness seem more biological, taking some of the stigma away.”

Most lay people, he says, don’t realise how little shrinks know about the underpinning of mental illness, though he’s not as convinced as Kirsch about the placebo effect and makes the point that the patients who turn up at his office are different from those recruited into clinical trials because drug companies, desperate to get their product to outperform a placebo, are picky about who they choose.

You have to have “pure” depression, unblemished by alcohol use, anxiety problems, bipolar disorder, suicidal thoughts, mild or long-term depression – which, says Carlat, would exclude most of his patients. Yet, as Marcia Angell, author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It, says: “It’s true… but they are the best we have.”

If there’s one thing that’s clear among the contradictions, it’s that the brain remains mysterious. As Carlat says: “Undoubtedly, there are neurobiological and genetic causes for all mental disorders, but they are still beyond our understanding.” All we really know is that depression exists and that sometimes the drugs seem to work – even if it’s a placebo effect.

Antidepressants: the guidelines

* Never stop taking antidepressants without discussing it with your doctor, because abrupt cessation of SSRIs can cause withdrawal symptoms that can be both physical and mental.

* If you do decide to stop, you’ll need to reduce the dose gradually rather than stopping abruptly.

* If you’re happy with your antidepressant and you feel it works for you, then keep on taking it. Regular use is what works: if it ain’t broke, don’t fix it, says Professor Irving Kirsch.

Mr Hitchens has written about SSRIs and their attendant problems in the past and he returns to the subject in his review (hat tip to the Truthman for this) of the upcoming film ‘We need to talk about Kevin’. The movie is about the perpetrator of a High School massacre in a fictional American town.

In the movie it transpires that Kevin had been taking prescribed antidepressants and uses the fact as part of his defence. However, it seems to be to be a great shame that the film lightly dismisses Kevin’s acknowledged use of SSRI drugs as no more than a cheap defence attorney’s get-out.

Hitchins writes: “I’ve mentioned here before (see index) the extraordinary correlation between such killings and SSRI ‘antidepressants’. (Yes, I know correlation isn’t causation. That is precisely why I call repeatedly for a proper investigation into the apparent link). I’ve also mentioned the growing doubts (see index, under ‘antidepressants’)  among doctors about the nature and real effect of these drugs, notably the powerful articles by Dr Marcia Angell, of the Harvard Medical School, recently published in the New York Review of Books.”

I agree – and I believe that antidepressants can cause extreme violence.

All too often in the past, it seemed that the only other people in the world who would ever begin to entertain the possibility were people such as Michael Moore and Dr Peter Breggin in the USA – and in England David Healy, Andrew Herxheimer and David B. Menkes, who co-authored a paper on the subject in 2006 – Antidepressants and Violence: Problems at the Interface of Medicine and Law.

If you want more information, then you can read follow up with these links (or just type ‘Violence’ in the search box on the left of your screen:

What made Raoul Moat do it

Nebraska shooting – antidepressant connection yet again?

Lost in translation – were Anti-Depressants Involved In Finland School Massacre?

A brief history of school shootings

The Finland Massacre

SSRI storiesAntidepressants and violence

There simply has to be a proper investigation into this issue – and I believe that the drug companies (such as Glaxo) know the problem exists, but have done nothing about it as it would have affected their profits.