The quest for fitness may be detrimental to your long term mental state

We are often told how we should aim to have, and maintain, a healthy lifestyle. After all, being physically fit allows your body to function both in physical and mental aspects. Healthy body, healthy mind, right?

The only difficulty, if you can call it that, with exercise is that the first thing that we would normally consider is running, but it is not for everyone. Going forward for a certain distance or time has little meaning for some people, especially children.

The thing about running is that it has to have some appreciable meaning, so unless you have some derivative inner joy of measuring your progress using statistics, it is unlikely to hold your interest for the long term. A better form of exercise is though group sports, as the mental boredom of tracking fitness levels is negated in favour of the social dynamic.

Common group sports such as football  have a large following in England. The football season for example lasts from August to May and provides a welcome distraction during the cold winter months. It is also a simple game that can be improvised using other materials and played on all surfaces. No goalposts? Use bags or some other markers. No football? Use a tennis ball. It is often interesting to see children turn up at a field, establish the boundaries of play using trees and creates goalposts using caps or other loose materials and these are often sufficient for the game; at least until there is discussion about whether the “ball” hit the post or went in the goal after it flies over a set of keys intended to represent the goalpost.

There is increasing concern about the link between dementia and football. The pounding of the ball against a soft surface of the brain, when the ball is headed, over time can cause the destruction of cells and cell function. This is of particular concern in the case of children, whose brains and bodies are developing. This has been of significant interest as members of England’s 1966 World Cup winning squad have found to have developed dementia in their later years. Some of them cannot even remember being there in 1966!

It is not just the impact of ball on head that is concerning, but when the head is moved through a range of motion too quickly. Even though there is no impact on the head externally, internally there is damage as the brain is hitting the sides of the skull supposed to protect it.

It is not just football that we have to be concerned about. There is plenty of head and neck related impact in rugby and American football. In fact, in American football, the head related injuries for offensive and defensive linemen, who every forty seconds start a play by ramming into the player on the opposite side of the line,  and the list of dementia sufferers is growing continually. Some players have even sued the NFL for injuries suffered during the game.

Will the rules of football change so that heading the ball is banned? Don’t bet on it. That would change the fabric of the game so much as to ruin it. When the ball is swung in from a corner, what would you do if you couldn’t head it? The game will not change, but also don’t rule out a consortium of players in the future filing lawsuits for work-related injuries. Perhaps in the pursuit of fitness, it may be wiser to choose less impactful activities for the sake of long term health.

Why mental health problems will never go away

Many people will experience mental health difficulties at some point in their lives. As people go through life the demands on them increase, and over a prolonged period these can cause difficulty and ill health. These problems can manifest themselves both in mental and physical ways.

What kind of demands do people experience? One of these can be work-related. People may experience  stresses of looking for work, having to work in jobs which do not test their skills, or be involved in occupations  which require skills that are seemingly difficult to develop. Another common theme with adults that causes stress is having to work in a job which increasingly demands more of them, but does not remunerate them accordingly. In other words, they have to work more for less, and have to accept the gradual lowering of work conditions, but are unable to change jobs because they have already invested so much in it in terms of working years, but cannot leave and start afresh because the demands of a mortgage to pay off and a young family to provide for means they cannot start on a lower rung in a new occupation. Over a prolonged period, this can cause severe unhappiness.

Is it surprising that suicide affects men in their thirties and forties? This is a period for a man where work demands more, the mortgage needs paying, and the family demands more of his time and energy. It is unsurprising that having spent long periods in this sort of daily struggle, that men develop mental health problems which lead some to attempt suicide. But mental health does not just affect men. Among some of the this some women have to deal with are the struggles of bringing up children, the work life balance, the unfulfilled feel of not utilising their skills, and feeling isolated.

One of the ways ill health develops mentally is when people spend too long being pushed too hard for too long. Put under these kind of demands, the body shuts down as a self preservation measure. But the demands on the person don’t just go away. You may want a break from work. But this may not be possible or practical. In fact, the lack of an escape when you are aware you need one may be a greater trigger of mental illness, because it increases the feeling of being trapped.

It is little wonder that when people go through periods of mental ill health, an enforced period of short-term rest will allow them to reset their bearings to be able to continue at work, or return to work with some level of appropriate support. But this is only temporary.

With mental ill health problems, lifestyle adjustments need to be made for sufficient recovery.

Under the Equality Act (2010), your employer has a legal duty to make “reasonable adjustments” to your work.

Mental ill health sufferers could ask about working flexibly, job sharing, or a quiet room, a government report suggests.

The practicality of this however means more cost to the employer in having to make adjustments to accommodate the employee, and unless the employee is a valued one, whom the employer would like to keep, often the case is that they will be gradually phased out of the organisation.

In fact, when an employee attains a certain level of experience within an organisation, employers often ask more of them because they know these employees are locked in to their jobs, and have to accept these grudgingly, or risk losing their jobs, which they cannot do if they have dependents and financial commitments.
And you know the irony of it? The mental ill health sufferer already knows that. Which is why they don’t speak out for help in the first place.

If these employees complain, employers simply replace them with younger employees, who cost less, and who are willing to take on more responsibilities just to have a job. Any responsibilities the redundant employee had simply get divided up between his leftover colleagues, who are in turn asked to take on more responsibilities. They are next in line in the mental health illness queue.

And what if you are self employed? And have to work to support yourself and your dependents? The demands of the day to day are huge and don’t seem to go away.

You can see why mental health is  perceived a ticking time bomb. Organisations are not going to change to accommodate their employees because of cost, but keep pressing them to increase productivity without pay, knowing that they cannot say no, and when all the life and juice has been squeezed out of them, they can be chucked away and replaced with the next dispensable employee.

A ticking time bomb.

An overview of mental health

Mental illness continues to be one of the most misunderstood, mythologised and controversial of issues. Described for as long as human beings have been able to record thoughts and behaviours, it is at once a medical, social and at times political issue. It can lead to detention against one’s will and has its very own Act of Parliament, and yet we really know very little about it.

Societies through the ages have responded to this mystery by the locking up of people whose sometimes bizarre behaviour was deemed dangerous, unsuitable or just plain scandalous. Only within the relatively recent past have the tall, thick walls of the asylum been dismantled and those who remained institutionalised and hidden allowed out into the community.

Little wonder then that mental health and mental disorder remain misunderstood to most, and frightening to many. Recent reports suggest that stigma is on the decline (Time to Change 2014) but progress has been slow. Despite the best efforts of soap scriptwriters, high-profile celebrities ‘coming clean’ about mental illness, and the work of mental health charities and support groups in demystifying diagnoses such as depression, we still see and hear many examples of discrimination and myth.

Given the sheer ubiquity of mental illness throughout the world, the stigma and mystery is surprising. The most recent national survey confirms the now well-known statistic that just under one in four English adults are experiencing a diagnosable mental disorder at any one time (McManus et al. 2009). Depression is identified by the World Health Organization as the world’s leading cause of years of life lost due to disability (WHO 2009).

Relatively few of those experiencing mental health problems will come to the attention of a GP, let alone a mental health professional. This is especially so in the developing world where initiatives to develop local mental health interventions are gaining considerable ground after generations of cultural stigma and ignorance (WHO 2009). But even in parts of the world where people have ready access to medical help, many suffer alone rather than face the apparent shame of experiencing mental health problems.

Perhaps part of our reluctance to accept mental illness lies with difficulties determining mental health. We are made aware of factors that determine positive mental health. Connecting with people, being active, learning new things, acts of altruism and being aware of oneself (NHS 2014) have been evidenced as ways of promoting our well-being, but mental order remains rather more loosely defined than mental disorder.

So what are the systems used to categorise and define mental illness? In the United Kingdom, mental health professionals often refer to an ICD-10 diagnosis to refer to a patient’s condition. This is the World Health Organization’s (WHO) diagnostic manual, which lists all recognised (by WHO at least) diseases and disorders, including the category ‘mental and behavioural disorders’ (WHO 1992). The Diagnostic and Statistical Manual of Mental Disorders (better known as DSM-5) is more often used in the United States and elsewhere in the world (American Psychiatric Association 2013). These two sets of standards are intended to provide global standards for the recognition of mental health problems for both day-to-day clinical practice and clinical researchers, although the tools used by the latter group to measure symptoms often vary from place to place and can interfere with the ‘validity’ of results, or in other words the ability of one set of results to be compared with those from a different research team.

ICD-10 ‘mental and behavioural disorders’ lists 99 different types of mental health problem, each of which is further sub-divided into a variety of more precise diagnoses, ranging from the relatively common and well known (such as depression or schizophrenia) to more obscure diagnoses such as ‘specific developmental disorders of scholastic skills’.

The idea of using classification systems and labels to describe the highly complex vagaries of the human mind often meets with fierce resistance in mental health circles. The ‘medical model’ of psychiatry – diagnosis, prognosis and treatment – is essentially a means of applying the same scientific principles to the study and treatment of the mind as physical medicine applies to diseases of the body. An X-ray of the mind is impossible, a blood test will reveal nothing about how a person feels, and fitting a collection of psychiatric symptoms into a precise diagnostic category does not always yield a consistent result.

In psychiatry, symptoms often overlap with one another. For example, a person with obsessive compulsive disorder may believe that if they do not switch the lights on and off a certain number of times and in a particular order then a disaster will befall them. To most, this would appear a bizarre belief, to the extent that the inexperienced practitioner may label that person as ‘delusional’ or ‘psychotic’. Similarly, a person in the early stages of Alzheimer’s disease may often experience many of the ‘textbook’ features of clinical depression, such as low mood, poor motivation and disturbed sleep. In fact, given the tragic and predictable consequences of dementia it is unsurprising that sufferers often require treatment for depression, particularly while they retain the awareness to know that they are suffering from a degenerative condition with little or no improvement likely.

Psychiatry may often be a less-than-precise science, but the various diagnostic terms are commonplace in health and social care and have at least some descriptive power, although it is also important to remember that patients or clients may experience a complex array of feelings, experiences or ‘symptoms’ that may vary widely with the individual over time and from situation to situation.

Defining what is (or what is not) a mental health problem is really a matter of degrees. Nobody could be described as having ‘good’ mental health every minute of every day. Any football supporter will report the highs and lows encountered on an average Saturday afternoon, and can easily remember the euphoria of an important win or the despondency felt when their team is thrashed six-nil on a cold, wet Tuesday evening. But this could hardly be described as a ‘mental health problem’, and for all but the most ardent supporters their mood will have lifted within a short space of time.

However, the same person faced with redundancy, illness or the loss of a close family member might encounter something more akin to a ‘problem’. They may experience, for example, anger, low mood, tearfulness, sleep difficulties and loss of appetite. This is a quite normal reaction to stressful life events, although the nature and degree of reaction is of course dependent on a number of factors, such as the individual’s personality, the circumstances of the loss and the support available from those around them at the time. In most circumstances the bereaved person will recover after a period of time and will return to a normal way of life without the need for medical intervention of any kind. On the other hand, many people will experience mental health problems serious enough to warrant a visit to their GP.

The majority of people with mental health problems are successfully assessed and treated by GPs and other primary care professionals, such as counsellors. The Improving Access to Psychological Therapies (IAPT) programme is a now well-established approach to treating mental health problems in the community. GPs can make an IAPT referral for depressed and/or anxious patients who have debilitating mental health issues but who don’t require more specialised input from a psychiatrist or community mental health nurse. Most people receiving help for psychological problems will normally be able to carry on a reasonably normal lifestyle either during treatment or following a period of recovery. A small proportion of more severe mental health issues will necessitate referral to a Community Mental Health Team (CMHT), with a smaller still group of patients needing in-patient admission or detention under the Mental Health Act.

Mental health is a continuum at the far end of which lies what professionals refer to as severe and enduring mental illness. This is a poorly defined category, but can be said to include those who suffer from severely debilitating disorders that drastically reduce their quality of life and that may necessitate long-term support from family, carers, community care providers, supported housing agencies and charities. The severe and enduring mentally ill will usually have diagnoses of severe depression or psychotic illness, and will in most cases have some degree of contact with mental health professionals.

Wort on earth: St John’s wort and its use as an anti-depressant

St John’s wort, also known as Hypericum perforatum, has for years been used as a treatment for nerves. Its use dates back to over hundreds of years. In medieval times, its reputation as a remedy for wounds, as well as sores, burns, bruises and nerve pains, gave it its popularity. Evil spirits were also thought to be repelled by it, and the insane would often drink an infusion of St John’s wort in an attempt to ward off madness. In modern times, St John’s wort has been used to manage seasonal affective disorder (SAD), improve sleep quality and improve mood.

St John’s wort is a tall wild plant and the flowers are yellow. It is often found growing wild in many parts of the world including Europe, Asia and the US, and is named after St John the Baptist as the traditional collection day was on St John’s Day, June 24th.

It is sometimes used by people with mild to moderate depression as an alternative to anti-depressants. It is in this group that scientists believe the best effects of St John’s wort are best demonstrated. We have seen in earlier posts that less severe depression, where sufferers are not in immediate danger, may not require anti-depressants or other medication and if they are not necessary, it is best not to use them as they can lead to addiction or have other side effects.

St John’s wort has been one of the most well-researched herbal medications. While the results of its use are not necessarily consistent, studies have demonstrated that if it is taken in the right form and with the correct dosage, it can have effective results on sufferers with mild to moderate depression. Scientists believe that it works in a similar way to SSRI drugs. SSRI (“selective serotonin re-uptake inhibitor”) drugs lift the levels of certain brain chemicals, such as serotonin, dopamine and noradrenalin, and in doing so make the user feel more positive. Drugs such as Prozac have the same effect. For mild to moderate depression sufferers this sort of herbal treatment is usually enough.

While St John’s wort is available as a traditional medicine, it is classed under “herbal” alternatives which are not necessarily regulated by law. This means that different variants are available, all with different consistencies. If you are considering this as a non-medical alternative, and are slightly puzzled by the variants on offer, it is best to start off with one that has been certified as a Traditional Herbal Remedy, or THR. The symbol for this is a leaf in a black square on the label, and is a useful starting point in guaranteeing the safety and purity of the product.
Effective products will contain a concentration of the active ingredient, hypericin, of about 0.3%. And a good guideline is a product that has a dose of around 300 – 900 mg of hypericin. Start with the median dosage of around 600mg and then adjust it according to how you feel.

It must be emphasised that the usage of St John’s wort has to be considered with the same caution of any prescription SSRI anti-depressants that it is meant to substitute. This means you should use it carefully, and not think that just because it is a natural herbal remedy, taking it – either within the guidelines or above the recommended threshold – will not do you any harm. The use of St John’s wort can cause interference with other drugs and lead to complications. St John’s wort may interfere with statins, blood thinners and also things like oral contraceptives like the pill. Possible side effects could also include nausea, skin allergies and hypersensitivity to sunlight. St John’s wort should also not be taken with drugs prescribed for depression, as that would result in an overdose of hypericin. If you are considering using it as a herbal substitute to reduce mild or moderate depression, it would be a good idea to check with your GP, or consult any other medical practictioner so you have some idea of the associated risks.

St John’s wort, in Germany, is classed as a prescription drug but outside of Germany, it can be readily bought at pharmacists without the need for a prescription. Is it more advantageous to the average person that it is classed as a herbal remedy?

On the face of it, yes – being classed as a herbal remedy means that depression sufferers may try it first before going to their GP. If the remedy works for them, this means that they are more likely to avoid addiction to anti-depressants, and the side effects of the latter. They are also more likely to avoid requiring long-term medication due to the build-up of anti-depressant resistance. Furthermore, users of St John’s wort need not visit their GP to obtain a prescription, so there is a time saving for the GPs and more appointments can be made available.

However, one may argue that its listing as an alternative health herbal remedy only complicates matters. St John’s wort is found in the form of tablets, teas and tincture. Herbal remedies, like vitamins, cannot make the claim that they can cure a certain illness, but manufacturers can claim they are good for certain purposes. Therefore, St John’s wort can be said to “be good for mild depression”, but not cure it. But this is not the only disclaimer found in the text in St John’s wort products. In trying to absolve itself of litigious claims, it is not uncommon to see on the labelling that St John’s wort should not be taken if:

  • you are under 18 years of age
  • you are pregnant or breastfeeding
  • you are allergic to any of the ingredients
  • you are lactose intolerant
  • your skin is exceptionally sensitive to sunlight (photosensitive)
  • you are having light treatment (phototherapy) for any condition
  • you are suffering from depression

The printed label may also advise you that it may also interfere with medicines such as:

  • fentanyl, propofol, sevoflurane, and midazolam (anaesthetics/pre-operative medicines)
  • tramadol (an analgesic)
  • erythromycin, clarithromycin and telithromycin (antibiotics)
  • itraconazole and voriconazole (antifungals)
  • artemether and lumefantrine (antimalarials)
  • rasagiline (an anti-Parkinson’s medicine)
  • aripiprazole (an antipsychotic medicine)
  • buspirone (an anxiolytic)
  • aprepitant (used to treat post-operative vomiting)
  • butobarbital and phenobarbital (barbiturates)
  • methyl phenidate (a central nervous system or CNS stimulant)
  • exemestane (a hormone antagonist)
  • eplerenone (a diuretic)
  • lansoprazole and omeprazole (proton pump inhibitors)
  • theophylline (a bronchodilator)
  • gliclazide (an antidiabetic medicine)

A longer, more detailed list may advise that St John’s wort should not be used for:

  • All medicines for depression/anxiety – Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine
  • All hormonal replacement therapy treatments – HRT tablets, patches and gels
  • All medicines for thinning the blood (anticoagulants) – Warfarin, acenocoumarol
  • All medicines for epilepsy – Carbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate
  • All immunosuppressant medicines – Ciclosporin, tacrolimus
  • All medicines for HIV infections – Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delavirdine
  • Cholesterol medicines such as Simvastatin, atorvastatin
  • Cancer medicines such as Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane
  • Heart disease medicines- Digoxin, ivabradine, amiodarone
  • Migraine treatments – Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
  • High blood pressure treatments – Amlodipine, nifedipine, felodipine, verapamil
  • A medicine for regulating mood – Lithium
  • A thyroid hormone – Thyroxine

The list of precautions and possible medication conflict is so long, that one may find sufferers who are actually already on medication may decide against switching or downgrading to St John’s wort.

The dosing and safety of St John’s Wort has – in addition – not been studied in children/ adolescents below 18 years and hence the safety of use is not established.

The problem with industry-funded drug trials

How much can we trust the results of clinical trials, especially ones that have been funded by companies with vested interests? This is the question we should continually ask ourselves, after the debacle of Seroxat.

The active ingredient of Seroxat is paroxetine. Medicines are known by two names, one of the active ingredient, the one that gives it the scientific name, and the other, the brand name. For example, the ingredient paracetamol is marketed under Neurofen, among other names. Companies that manufacture their own brand of medicine may decide to market it little more than their company name before the active ingredient, for example, Tesco paracetamol or Boots Ibuprofen, in order to distinguish it from other rival brands and aligning it with an already recognised scientific name, but without the associated costs of having to launch a new product brand.

Paroxetine is an anti-depressant and made its name as one of the few anti-depressants to be prescribed to children. However it was withdrawn from use after re-examination of the original scientific evidence found that the results published in the original research were misleading and had been misconstrued.

The prescription of medications to children is done under caution and monitoring, as there are various risks involved. Firstly, there is the danger that their bodies adapt to the medication and become resistant, thereby necessitating either higher doses in adult life, or a move on to stronger medication. In this instance there is the possibility that rather than addressing the problem, the medication only becomes a source of life-long addiction to medication. The second risk is that all medicines have side effects and can cause irreparable damage to the body in other regions. For example, the use of aspirin in the elderly was found to damage the lining of the stomach.

Equally worrying is the effect of these drugs on the health of the mind. Some drugs, particular those for mental health, are taken for their calming effect on the mind. The two main types of mental health drugs can be said to be anti-depressants and mood stabilisers, and while the aim of these drugs is to limit the brain’s overactivity, some have been found to trigger suicidal thoughts in users instead, ironically performing the function they were meant to discourage.

Children are often currently either prescribed adult medication in smaller doses of half strength instead, but the difficulty in assessing the dosage is that it does not lend itself to being analysed on a straight line graph. Should children under a certain age, say twelve for example, be prescribed as doseage based on age? Or if the most important factor in frequency is the body’s ability for absorption, should we prescribe based on other factors such as body mass index?

So when Seroxat came on to the market marketed as an anti-depressant for children you could almost feel the relief of the parents of the young sufferers. A medical product, backed by science and research, suitable for children, approved by the health authorities. Finally a medical product young sufferers could take without too much worry, and one – having been tested with young children – that parents could be led to surmise would be effective in managing their children’s mental health.

Except that Paroxetine, marketed as Seroxat, was not what it claimed to be. It has been withdrawn from use after scientists found, upon re-analysing the original data, that the harmful effects, particularly on young people were under-reported. Furthermore, researchers claim important details that could have affected the approval of its license were not made public, because it might have meant years of research might have gone down the drain.

When a medical product is launched, it is covered under a twenty-year no-compete patent, which means that it has a monopoly on that medicine for that period. While one might question why that is so, it is to protect the time spent by the pharmaceutical companies in investing in research and marketing the product, and give it a time period to establish a sizeable market share as a reward for developing the medication.

Twenty years for a patent might seem like a long term, but as companies apply for it while the product is in the early stages of development, in order that its research is not hijacked by a competing pharmaceutical company, they are often left with a period of ten years or less by the time the medical product has some semblance of its final form. The patent company has that amount of time to apply for a license and to market and sell the medication. After the original twenty years has elapsed, other companies can enter the fray and develop their own brands of the medicine. They, of course, would not need to spend the money on research as much of the research will have already been done, published, and accessible – enough to be reverse-engineered in a shorter space of time. Pharmaceutical companies are hence always engaged in a race against time, and if a product hits a snag in trials, mass production is put on hold – and if the company is left with anything less than five years to market its product, it is usually not long enough a period to recoup research costs. And if it is less with anything less than three years, it might as well have done the research for the companies that follow, because it will not recover the costs of research and marketing. While not proven, it is believed that pharmaceutical companies hence rush out products which have not been sufficiently tested, by emphasising the positive trial results, and wait for corrective feedback from the market before re-issuing a second version. It is not unlike computer applications nowadays which launch in a beta form, relying on user feedback for improvement, before relaunching in an upgraded form. The difference is software has no immediate implications on human health. Medication does.

Researchers who re-examined data from the medical trial of the antidepressant paroxetine, found reports of suicide attempts that had not been included in the original research paper. And because the makers of paroxetine, GlaxoSmithKline (GSK), had marketed paroxetine as a safe and also effective antidepressant for children, even though evidence was to the contrary, GSK had to pay damages for a record $3 billion for making false claims.

In the original research trials, GSK claimed that paroxetine was an effective medication for treating adolescents with depression and it was generally well-tolerated by the body with no side effects. Subsequent analysis found little advantage from paroxetine and an increase in harm in its use, compared to placebo.

The whole issues highlights the difficulty in trusting medical trials whose data is not independently accessed and reviewed.

The current stance on data is that pharmaceutical companies can select that clinical data they choose to release. Why is this so? We have already covered the reason for this. They have committed funds to research and are hence protective (and have right to be) protective of the raw data generated, particularly when competitors are waiting in the fold to launch products using the same data.

If you were a recording artist, and hired a recording studio for two weeks, musicians to play for you and sound engineers to record your work, at the end of the two weeks, you might have come up with a vast amount of recordings which will undergo editing, and from which your album will be created, then whatever has been recorded in the studio is yours, and you have the right to be protective about it in order that someone else might not release music using your ideas or similar to yours.

The problem is that when the pharmaceutical company initiating and funding the research is the one that will eventually market it first, and the clock is ticking against it, then it has a vested interest in the success of the product and is inherently biased to find positive outcomes that are advantageous to the product it creates.

Who would commit twenty years of time, research, marketing and finance to see a product fail?

The pharmaceutical company is also pressured to find these outcomes quickly and hence even the scientific tests may be already geared to ones that lead to pre-determined conclusions rather than ones that open it up to further analysis and cross-examination, and take up precious time or cause delay.

This creates a situation where only favourable data has been sought in the trials and only such data is made publicly available, leading to quick acceptance of the drug, a quick acquisition of a license and subsequently less delay heading into the marketing process.

The alternative is for independent review of the raw data, but this causes additional stresses on the time factor, and the security of the raw data cannot be guaranteed.

Despite the limitations of the current system, there are attempts to reform the system. The AllTrials campaign is a pressure group seeking independent scrutiny of medical data and has backing by medical organisations. The AllTrials group argue that all clinical trial data should be made available for the purpose of independent scrutiny in order to avoid similar issues to the misprescribing of paroxetine from repeated occurrence in the future.

The original study by GSK reported that in clinical trials 275 young people aged 12 to 18 with major depression were randomly allocated to either paroxetine, an older antidepressant drug called imipramine, or a placebo for eight weeks.

The researchers who reviewed the previous original study in 2001 found that it seriously under-reported cases of suicidal or self-harming behaviour, and that several hundreds of pages of data were missing without clear reason. It is likely these did not look upon paroxetine favourably.

Data was also misconstrued. For example, the 2001 paper reported 265 adverse events for people taking paroxetine, while the clinical study report showed 338.

The data involved examining 77,000 pages of data made available by GSK, which in hindsight, might have been 77,000 pages of unreliable data.

This study stands as a warning about how supposedly neutral scientific research papers may mislead readers by misrepresentation. The 2001 papers by GSK appear to have picked outcome measures to suit their results.

It subsequently come to light that the first draft paper was not actually written by the 22 academics named on the paper, but by a ghostwriter paid by GSK.

That fine for GSK might be seen as small in light of this. Certainly the reliability of industry-funded clinical trials, and how the process can be overhauled, is one we need to be considering for the future.