SSRIs can give you digestive problems… and make you MORE depressed

Another hat-tip to the Truthman for this story from the Daily Mail.

As I’ve said before, the truth is slowly drip, drip, dripping out – one day I’m sure my children will be appalled that so many prescriptions were written for drugs like Seroxat that turned out to be so harmful to so many patients, much like the Thalidomide and Benzo scandals of the past.

What compounds matters for me is the role of the drug companies, like GlaxoSmithKline, that continued to aggressively market Seroxat, even when company insiders knew the drug was defective, dangerous and ineffective.

There was money  to be made and GSK wasn’t going let anything like negative trial results get in the way of profit. Especially not when Key Opinion Leaders could be relied on to say whatever a drug company told them to say – providing the KOLs were paid enough.

Anyway, I’ll get off my soapbox now and let you read the article from the Daily Mail:

Depression levels in Britain continue to spiral.

Last year alone, more than 43 million prescriptions for antidepressants were handed out — 25 per cent more than three years before.

But are antidepressants the panacea we hope them to be?

Drugs such as Prozac [and Seroxat] were hailed in the early Nineties as wonder pills that would banish depressive blues for good.

But in the past five years, growing scientific evidence has shown these drugs work for only a minority of people.

And now controversial research in a respected journal claims that these antidepressants can make many patients’ depression worse.

This alarming suggestion centres on the very chemical that is targeted by antidepressants — serotonin.

Drugs such as Prozac [and Seroxat] are known as selective serotonin reuptake inhibitors (or SSRIs).

Their aim is to boost the level of this ‘feel-good’ chemical in the brain.

But the new research, published in the journal Frontiers In Evolutionary Psychology, points out that serotonin is like a chemical Swiss Army knife, performing a very wide range of jobs in the brain and body.

And when we start deliberately altering serotonin levels, it may cause a wide range of unwanted effects.

These can include digestive problems, sexual difficulties and even strokes and premature deaths in older people, according to the study’s lead researcher Paul Andrews. 

‘We need to be much more cautious about the widespread use of these drugs,’ says Andrews, an assistant professor of evolutionary psychology at McMaster University in Ontario, Canada.

Previous research has suggested that the drugs provide little benefit for most people with mild and moderate depression, and actively help only a few of the most severely depressed.

Eminent psychologist Irving Kirsch has found that for many patients, SSRIs are no more effective than a placebo pill.

Two years ago, the Canadian Medical Association Journal reported a 68 per cent increase in risk of miscarriage in women on antidepressants.

Drugs such as Prozac [and Seroxat] are known as selective serotonin reuptake inhibitors (or SSRIs). Their aim is to boost the level of this ‘feel-good’ chemical in the brain

And research in 2009 on Danish children found a small, but significant, increase in the risk of heart defects among babies whose mothers had used SSRIs in early pregnancy.

There is also growing evidence that long-term use in adults is linked to bleeding in the gut and increased risk of stroke.

The key to understanding these side-effects is serotonin, says Andrews. Serotonin is also the reason why patients can often end up feeling still more depressed after they have finished a course of SSRI drugs.

He argues that SSRI antidepressants interfere with the brain, leaving the patient vulnerable to a ‘rebound’ depression of even greater intensity than before.

‘After prolonged use [when a patient stops taking SSRIs], the brain compensates by lowering its levels of serotonin production,’ he says, adding that it also changes the way receptors in the brain respond to serotonin, making the brain less sensitive to the chemical.

These changes are believed to be temporary, but studies indicate that the effects may linger for up to two years.

Relapsing is not exclusive to SSRI drugs — it is, in fact, seen in all the classes of antidepressant medications — but Andrews believes that the risk is particularly strong with SSRI drugs.

Moreover, he warns that antidepressants can disrupt all the physical processes that are normally regulated by serotonin, adding that animal studies show only about 5  per cent of the body’s serotonin resides in the brain. Most is housed in the gut.

It is used, among other things, to control digestion, form blood clots at wound sites, and regulate reproduction and growth.

So a drug that interferes with serotonin may cause developmental problems in infants, problems with sexual stimulation and sperm development in adults, digestive problems such as constipation, diarrhoea, indigestion and bloating, and abnormal bleeding and stroke in the elderly.

The drugs may also raise the risk of dementia.

Most disturbingly of all, Andrews’ review features three recent studies which, he says, show that elderly antidepressant users are more likely to die prematurely than non-users, even  after taking other important variables into account.

One study, published in the British Medical Journal last year, found patients given SSRIs were more than 4 per cent more likely to die in the next year than those not on the drugs.

‘Serotonin is an ancient chemical,’ says Andrews.

‘It is intimately regulating  many different processes, and when you interfere with these things, you can expect that it is going to cause some harm.’

Stafford Lightman, professor of medicine at the University of Bristol, and a leading UK expert in brain chemicals and hormones, says Andrews’ review highlights some important problems, yet it should also be taken with a pinch of salt.

‘This report is doing the opposite of what drug companies do,’ he says.

‘While drug companies selectively present all the positives in their research, this selectively presents all the negatives that can be found.

Both approaches are simplistic. And while SSRIs might possibly cause rebound depression, it is also sadly natural to expect that people with severe depression will see their illness come back, and often in a worse state.

‘Nevertheless, the study is useful in that it is always worth pointing out that there is a downside to any medicine.’

Professor Lightman adds that there is still a great deal we don’t know about SSRIs — not least what they actually do in our brains.

‘It’s a bit embarrassing, but the bottom line is that we don’t really know how they work,’ he says.

‘Basically, we started using these drugs before we understood what they do, because they showed some effectiveness.’

When it comes to understanding why the drugs work only for a limited proportion of patients, U.S. scientists think they might now have the answer.

They think that in many clinically depressed patients, it’s not only the lack of feel-good serotonin causing their depression, but also a failure in the area of the brain that produces new cells throughout our lives.

This area, the hippocampus, is also responsible for regulating mood and memory. Research suggests that in patients whose hippocampus has lost the ability to produce new cells, SSRIs do not bring any benefit.

But why the hippocampus should do this — and how it should be treated — is not clear.

And even if those answers were found, they might still not produce a cure for many cases of depression, because the condition varies so widely in its causes and is so little understood.

What should be sure is that the days of doctors habitually prescribing SSRIs to all and sundry on the basis that they might work, and won’t do any harm anyway, really should be behind us.

Can you really believe they said this – 2012 reprise

They say hindsight is 20/20 vision.

Well, here are a bunch of quotes I’ve posted over the years for you to consider with the gift of hindsight.


It’s not possible really to measure total serotonin. We do not know with absolute certainty about how any of the antidepressants work. 
Alan Metz 
Glaxo Vice President for Clinical Development
source: Generation RX

No, we are not misleading them [patients]. The information in the patient leaflet and in the information we supply to doctors, is based on fact. 
Dr. Alastair Benbow 
Head of European Psychiatry for GlaxoSmithKline

….there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services

Physical and Psychologic Dependence: PAXIL has NOT been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic…
GSK Patient Information Leaflet

If ‘discontinuation reactions’ occur in patients stopping [Paxil], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks. 
Mary Anne Rhyne 
GlaxoSmithKline spokesperson

Drugs like Seroxat [Paxil] have been around for almost a decade and help millions of people fight depression. There’s no reliable scientific evidence to show they cause withdrawal symptoms or dependency. 
Alan Chandler 
GlaxoSmithKline spokesperson

These problems [’discontinuation reactions’] are just the body’s adjustment when you stop taking medicines. It takes more than that to be addictive. 
Mary Anne Rhyne 
GlaxoSmithKline spokesperson

The side effects [of Paxil “discontinuance”] are things like dizziness, nausea, headache, um, and are clearly labeled in the information made available to doctors and patients. 
Dr. Alastair Benbow 
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

I think patients have nothing to fear from taking Seroxat. 
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director

Experts including the FDA and leading physician and mental health organizations agree that antidepressant medications like Paxil are non-habit-forming. 
David Stout President
US Pharmaceuticals

It was quite clear from talking to patients and as a doctor that’s very, very important to me, it’s quite clear that the phrase “Seroxat is not addictive” was poorly understood by them. 
Dr. Alastair Benbow 
Head of European Psychiatry for GlaxoSmithKline

I think you have to develop a culture where if there is bad news you don’t sit on bad news. Bad news does not get any better. It can only get better if it’s admitted, understood and addressed.
Robert (Bob) Ingram
Vice Chairman, GlaxoSmithKline Pharmaceuticals

We’re reviewing every single process at the company. The environment of the business has changed after Enron. I believe that there was a lack of trust [on the part of] the public for big business, and that lack of trust has been amplified by a few bad apples in the cart. And because of that, there has been a tremendous loss of trust in all big business not just pharma and that has implications to me as a CEO.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline

Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.”
Mary Ann Rhyne
GlaxoSmithKline spokesperson

We don’t want to be accused of anything about the way we deal with trials.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline

As a knowledge-based industry we understand full well the value of information, and we want to create a climate of openness where the evidence for prescribing our products is clear.
Richard Sykes
Chairman of Glaxo Wellcome

I think if, if we’ve been guilty of anything over the past few years, perhaps, um, emphasizing entertainment over education, um, we know that’s what patients really want.
Christopher Viehbacher
GlaxoSmithKline U.S. President

Seroxat does have side effects, but these are clearly stated in the information that’s made available to doctors and to patients.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline

My wife thinks J.P. [Garnier] is the best thing since sliced bread. 
Christopher Viehbacher
GlaxoSmithKline U.S. President

We are a high-integrity company. We know what the rules are and we follow them.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline

The vast majority of drugs more than 90 per cent only work in 30 or 50 per cent of the people, I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don’t work in everybody. 
Dr. Allen Roses 
GlaxoSmithKline Senior V.P.
Genetics Research

If anyone thought drugs were without side-effects, hopefully that’s over. All drugs have side-effects. We are having to spend hundreds of millions of dollars on lawyers.
Jean-Pierre Garnier 
Chief Executive Officer

We follow the law, and we follow government guidelines. 
Mary Anne Rhyne 
GlaxoSmithKline spokesperson

This is a company that is reinventing itself … possibly creating a model for pharma companies. 
Jean-Pierre Garnier 
Chief Executive Officer

The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm. 
Dr. Alastair Benbow 

GlaxoSmithKline’s European Medical Director

So we always want to make sure we are serving the good, the right purpose…. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services

I’ll be a hero in three years. 
Jean-Pierre Garnier 
Chief Executive Officer GlaxoSmithKline

I am sure it happens because academics are very, very busy people, and they prefer to do research than spend a lot of time writing papers. If the industry puts forward a method of relieving them of that chore, then I am sure that that does happen throughout the industry. That would be true generally. Is it a good idea? I think it can be, as long as everybody is in agreement with what is written at the end of the day, the results and what they are. 
Sir Richard Sykes 
former Chairman of GlaxoSmithKline
On the industry practice of “ghostwriting medical reports” and “gift authorship.” 12/7/2004

We have acted responsibly in conducting clinical studies in pediatric patients and the dissemination of the results. We would strongly disagree with any allegation that we have done otherwise. 

Dr. Tadataka Yamada 
Chairman of Research and Development

You can experience symptoms, as you can with other SSRIs and as you can with other kinds of medicines as well. 
Mary Anne Rhyne
GlaxoSmithKline spokesperson

What we have seen in terms of the anecdotal reports [of Paxil withdrawal] is that it happens very rarely. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services

While GlaxoSmithKline strives to produce medications that safely and effectively treat medical conditions, we’re also committed to protecting the environment. 
Dr. Anne Phillips 
Chief Medical Officer of GlaxoSmithKline
source: GlaxoSmithKline

As you can see here, few numbers of patients experienced any adverse event after being randomized off [Paxil] into the placebo group and the percentages are certainly very small. But these were the common adverse events seen in that small population in our attempt to systematically assess a discontinuation syndrome. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services Excerpt from a transcript of the FDA Review of Paxil

I have my iPod and my Bose headphones. You can run anywhere. I’m in a bubble. When I go home I don’t talk about my job. It drives my wife crazy because when we go out she doesn’t know anybody. Socially we see politicians we have to and she knows nothing about the issues. But that’s the way I like it. I want to go home and say, ‘hey what happened to you?’ I have a very demanding job and I don’t want to go home and discuss the same stories. 
Jean-Pierre Garnier 
Chief Executive Officer

We feel strongly that we have an obligation to speak up both for the millions of patients that Seroxat allows to lead a normal life, and for our employees whose commitment to this important medicine has made such a positive difference to so many people. 
Eddie Gray 
General Manager
GlaxoSmithKline UK

My mum, you know, she thinks her son walks on water….. 
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline

….recognize that in the final analysis success rests on selecting the right people to work with. If you have the right people, the rest will follow. 
Jan Leschly 
Former CEO of SmithKline Beecham

It’s becoming too easy for many people to attack the pharma industry and hold the pharma industry to standards that are higher than anywhere else. I don’t have a problem with the standards….

Jean-Pierre Garnier 
Chief Executive Officer

Of course we didn’t follow this advice. Of course we didn’t selectively publicize the data. This is not a smoking gun. It’s a stupid memo and there are lots of stupid memos in every company’s file and it is really unfair to look at the company’s action through the small hole of one memo written among thousands and thousands in 1998. I do regret that those memos exist but I’m not going to lose sleep over the fact.
Jean-Pierre Garnier 
Chief Executive Officer

I utterly refute any allegations we are sitting on data, that [we] have withheld data or anything like that. We have provided all the data both relating to safety and efficacy in the pediatric population to the regulatory authorities around the world and have hidden nothing.
Dr. Alastair Benbow 
Head of European Psychiatry for GlaxoSmithKline

Corporate responsibility is not just a job for selected people at GSK, it defines the way we do business. Our ten corporate responsibility principles set thestandard for everyone, since responsible business is only a reality if it is practised by all employees at all times. 
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

The overwhelming view of independent medical experts and regulatory bodies around the world who have seen the data, is that Seroxat has a well established safety profile and is an effective treatment with experience in tens of millions of patients worldwide since launch in the UK over ten years ago. 
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline 10/10/2002

Human behavior is we know so little about it, and therefore, to try to speculate on a mechanism for human behavior is very difficult. 
Dr. Tadataka Yamada 
Chairman of Research and Development GlaxoSmithKline 1/24/2001

Sometimes a system indeed hinders your rise up the ladder but you also have to accept personal responsibility. That translates into realizing that it’s not always someone else’s fault that you didn’t get promoted. You have to ask some serious questions of yourself before you point the finger at someone else. Ask yourself, `What have I done?’ ‘What is my role in this?’ ‘What am I willing to do?’ 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services

If we meet the test of our highest purpose nothing less than making historic contributions to human welfare then we will surely meet our important responsibilities to other GlaxoSmithKline stakeholders, to the investors who put their trust in our performance, to the communities in which we operate, to our colleagues and to ourselves. 
Dr. Tadataka Yamada 
Chairman of Research and Development
GlaxoSmithKline from GSK’s web site

We are all in favour of this being scrutinized all the time, because it is not in our interests to have a product on the market that is not safe or effective. 
Jean-Pierre Garnier 
Chief Executive Officer
GlaxoSmithKline 2/15/2002

I think fundamentally the public needs to be reassured that multinational companies and globalisation are not bad quite the reverse. 
Jean-Pierre Garnier
Chief Executive Officer

We take the safety of our medicines extremely seriously…. 
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

First of all let me say that we, as a manufacturer of pharmaceutical products and vaccines, take any report of an adverse event on any of our products, seriously. 
Dr. David Wheadon 
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services

Great [GSK] products, however, are not the whole story society expects companies to act responsibly in their pursuit of success. If anything, the fact that our business is about human health makes it even more important that we operate to the highest standards.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

I think to focus on safety is important.
Dr. Tadataka Yamada
Chairman of Research and Development

….my experience is that most physicians don’t look at the [a drug safety] label very carefully. And I’m not certain. I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section….
Dr. Tadataka Yamada
Chairman of Research and Development

Responsible business practices are also the key to a good reputation. In 2004, the pharmaceutical industry and GSK continued to come under public scrutiny on how medicines are developed, tested and marketed. To meet this challenge we must act with integrity and be open about our approach to these important issues.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

Our concern is people’s safety.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline

Anybody who suffers side effects of any sort I feel every sympathy for….
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline

Everybody who has looked at this the FDA, American Psychiatric Association, National Mental Health Association all those groups agree that SSRIs, like Paxil, are not addicting and not habit forming.
Andrew T. Bayman
attorney for GlaxoSmithKline
King & Spalding

GSK strongly stands behind the safety and efficacy of Paxil. Physician organizations, like the American Psychiatric Association, have stated that antidepressants are not habit-forming.
David Stout
President of U.S. Pharmaceuticals, GlaxoSmithKline

GlaxoSmithKline is proud to offer physicians Paxil CR the latest treatment advance in the SSRI class.
David Stout
President, US Pharmaceuticals, GlaxoSmithKline

We missed something big we missed the fact that the public wasn’t going to necessarily trust us.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline


Glaxo – a simple challenge for you…

It’s been a while since I wrote anything as I’ve been very busy with my day job.

Happily, others have continued to write – I’ve just read a post over at Seroxat Suffers about Glaxo in New Zealand and the Patient Information Leaflet that comes with Aropax (Seroxat).

According to Glaxo (only in New Zealand, though):

Depression is longer lasting or more severe than the low moods that everyone has from time to time. It is thought to be caused by a chemical imbalance in parts of the brain.

AROPAX corrects the chemical imbalance and so helps relieve the symptoms of depression.

Sorry, but I have to throw the gauntlet down to Glaxo on this one… I think in 2012 it’s fair to say that the chemical imbalance story has been discredited completely.

But, Glaxo, if you can tell me what the correct level of Serotonin is in a human brain, then I’ll listen.

If you can measure how much Serotonin I currently have in my brain, then I’ll listen.

If you can then demonstrate how much 20mgs of Seroxat will raise my brain serotonin level by, then I’ll listen.

But the problem is that Glaxo can’t do any of those – the idea of a ‘chemical imbalance’ causing depression – and even the term ‘SSRI’ – was invented by marketing and PR companies, simply to sell a drug.

To use a technical term, it’s complete bollocks.



If you don’t want to believe me…

I think we all know the internet is overflowing with all kinds of dubious sources of ‘information’ sources.

I’m a patient who suffered greatly at the hands of GlaxoSmithkline and decided to tell my story by creating this blog. As such I freely admit that I am not, by any stretch of the imagination, unbiased.

I see what I do as trying to counter (in some small way) the spin and lies that Glaxo routinely produces every week of the year.

I also hope I may be able to help some people understand what’s happening to them if they are suffering from Seroxat addiction and are trying to withdraw from the drug.

But if you don’t want to believe me, then can I suggest you look at the new blog written by Dr David Healy – Dr Healy being the internationally respected psychiatrist, pyschopharmacologist, scientist and author. I can’t recommend this blog enough. Go there now!

And for the record:

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

I believe that Seroxat is addictive.

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

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

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.

Maybe you should believe me – I do know what I’m talking about.

The MHRA, Ian Hudson and the House of Commons

Just to follow on from yesterday’s post about the MHRA and its links to Big Pharma, I thought this might be of interest.

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.

The MHRA – still useless after all these years…

For those of you late to the party, the MHRA is supposed to be here to protect patients by licencing and regulating medicines (and medical devices) to make sure they are safe.

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.

 Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) admitted the safety of breast implants was actually impossible for it to judge

‘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.

 Vioxx 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

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]

Diagnostic and Statistical Manual of Mental Disorders: DSM-V on its way… but how much can we trust it?

The American Psychiatric Association (APA) is a very powerful body that has, since 1952, produced various versions of the Diagnostic and Statistical Manual of Mental Disorders – and the fifth edition is on its way.

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.


More dodgy drug company sponsored ‘research’?

It’s been brought to my attention that the Daily Mail ran a story yesterday about a piece of new research. The headline trumpeted:

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].

Doctors sued for creating addicts

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.

Lawyers and medical experts have reported an increase in clinical negligence cases by patients left physically and psychologically broken by “indefensible” long-term prescribing of addictive tranquillisers such as Valium, collectively known as benzodiazepines.

Patients taken off the drugs too quickly, leaving them disabled with pain for months if not years, are also seeking legal redress. Many say they were never told about the dangers of rapid detoxification, which can lead to seizures and even death in severe cases. Doctors have been accused of being “in denial” about the problem.

Experts have warned of a coming flood of legal action against doctors who failed to inform their patients about the addictive nature of some tranquillisers, currently given to millions of people worldwide. They are prescribed to deal with common social and psychological complaints, from exam stress to relationship problems and bereavement.

Professor Malcolm Lader, whose research in the 1980s suggested a link between long-term tranquilliser use and brain damage, said he now gives legal advice about negligent prescribing and dangerous detoxifications “at least every three months”.

He told The Independent: “There is no sign that such prescribing is diminishing. The Royal College of GPs is in denial about this because they fear being sued. With around a million long-term users, the [legal] defence unions will at some point decide that these cases are indefensible and GPs will have to pay their own costs.” A report by the All Party Parliamentary Group on Drug Misuse estimated in 2009 that there were 1.5 million involuntary tranquilliser addicts in the UK. More than 6.6 million benzodiazepine prescriptions for anxiety were dispensed by England’s pharmacies in 2010, a 15 per cent increase in 10 years. Prescriptions for Valium have increased by 20 per cent over the same period.

The first successful legal claim against individual doctors dates back to 2002, when Ray Nimmo, who was prescribed Valium for 14 years, won his case against GPs in Scunthorpe. His lawyer, Caroline Moore, has had five new referrals in the past month.

Some people develop a tolerance after regular use for two weeks, needing a higher dose to induce the same effects; others report using them for years with few adverse effects. For most, stopping is the problem: they can experience a range of painful psychological and physical symptoms, worse than their original complaint.

Dr Adrian Rogers, a GP who is also an expert in medico-legal cases, said: “I can’t believe there aren’t more claims. The fact that lots of doctors are prescribing long-term isn’t an excuse – no responsible GP would do it.”

There are only a handful of specialist tranquilliser withdrawal services across the UK. Most people rely on inexpert help from GPs or addiction services aimed at illegal-drug addicts. Recovery Road, a new helpline, receives around 250 calls a month, mainly from those who have detoxified too rapidly. “These poor people describe being in a kind of torture chamber,” said Baylissa Frederick, of the organisation.

The Bridge Project in Bradford tracks down long-term benzodiazepine users. In five months this year, one of its specialist drugs workers helped 102 patients.

Dr Chris Ford, a GP and benzodiazepine expert, is drafting new guidance to help doctors avoid creating addicts and advise them on the best way safely to detoxify those who are already dependent. Controversially, it will endorse long-term use for a limited number of patients. “These are good drugs – they work, but it is a slippery slope if doctors do not have systems in place to make sure they are only used in the short term,” she said.

“These people should not be treated like illicit drug users. Any detox has to be done very slowly. These drugs can cause serious long-term problems, so GPs should encourage people to come off them, but, for some, it is necessary to compromise. No one should be forced to withdraw,” she added.

A Department of Health spokeswoman said: “The Government’s drug strategy set out [in the White Paper Healthy Lives, Healthy People] an ambition to tackle dependence on all drugs, including prescription and over-the-counter medicines. It is clear that this is a problem that affects some people in most areas and is much unreported. Public health bodies will be responsible for the commissioning of services to support people recovering from dependence.”

Lives blighted by addiction

Rachel, 62, from the Midlands. Rachel (not her real name) is trying to sue an NHS clinic that detoxed her from tranquillisers so rapidly she has been left bedridden

“Around nine years ago my GP prescribed me Valium. I didn’t know it was addictive; my doctor kept giving me repeat prescriptions over the phone. I didn’t have any problems until five years ago when I started to get numbness in my face and irregular heartbeats.

“I was offered a detox in an NHS rehab unit… I was in for five weeks, and they cut me down 1mg every other day, which they insisted was very slow. It was absolute hell.

“I didn’t want to go back on the drug but I had no choice. Most days I can’t stand up… my memory has gone. Listening to those detox people is the biggest mistake I ever made. The doctor won’t accept the pain is caused by the withdrawal.”

Janet Marshall, 53, from Wakefield, West Yorkshire, won £25,000 in an out-of-court settlement from her GP after “losing” 28 years to prescribed benzodiazepines

“I was 26, I’d just had my fourth baby, and I had a panic attack. I called the GP because I thought I was dying, and was prescribed oxazepam, even though I was breast-feeding. I became hooked, taking 15 10mg tablets a day at one point.

My fifth child was born an addict; he suffered withdrawal symptoms, but by this time I couldn’t cope without them. Sometimes my pharmacist would give me some to tide me over the weekend if I’d run out. Five years ago, I changed GP, and she said I had a problem and started cutting me down, but far too quickly. It was like the doctors were my drug dealers. I couldn’t talk properly or stop shaking. It lasted for months, but I felt so much more alert and got my senses back.

“I feel angry and bitter at the Government, the pharmaceutical companies, the GPs – they all knew about it. I was a healthy normal person before the benzos; I was a good mother but I was robbed of that. I feel so guilty about my kids.”

MHRA – too little, too late: once again

I’ve just read the new SSRI Learning Module on the MHRA website – the MHRA says “it’s for medical, nursing and pharmaceutical professions, and is suitable for those nearing the end of their formal training or those who have recently completed such training. Also, health professionals will find the module a helpful refresher, for example, at the start of a posting in clinical psychiatry.”

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.


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