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.

What antibiotics in agriculture are really about

There is widespread concern over the use of antibiotics in the agricultural world and what is wider bearings are. The general consensus is that the use of antibiotics in agriculture needs to be minimised dramatically by farmers, as there are fears that drug-resistant bacteria could pass up the food chain through consumption and environmental contamination.

The concerns take on many forms. Firstly, just as humans can develop resistance to medicines after prolonged use, there is the concern that long-term antibiotic use in agricultural settings may create antibiotic resistance in the animals and crops which receive these antibiotics. Secondly, even if these crops and animals themselves do not develop resistance to antibodies themselves, the prolonged consumption of the vegetables or meat from these farm animals could breed resistance in humans who consume them. There may also be other side effects we are as yet unaware of.

Antimicrobial drugs, which include antibiotics, antifungal and antiparasitical drugs, are commonly used in farming. They are used to prevent damage to crops, kill parasites, as well as keep livestock healthy. The long term aim of antimicrobial drugs in the context of farming is to maximise crop production and livestock farming. A field of crops lost to infestation is months of work for nothing. A farmer with a field of cows suffering from disease has lost not just capital but production possibilities as well. As with the case of mad-cow disease in the 1990s, farmers who had their cows put down not only lost the money they had invested in buying and breeding these cows, but also on the sale of milk and beef.

And in many cases, the losses from a brief period of crop infestation or animal disease could significantly affect a farmer’s income, or make such a dent in their livelihood that it either forces them to take on additional debt to cover the losses, or be so insurmountable that it forces them out of business.

There might be those that argue against the use of antibiotics but the truth is that they are necessary. They are one form of insurance for a sector that has to combat various problems, including the uncertainties of weather. When, for example, your crops – your livelihood – are subject to the whims of weather, infestation, and perhaps human vandalism and theft, you have to take steps to minimise risks on all fronts. You cannot simply just leave things to chance and hope for divine favour or faith – that would merely be masking a lack of responsibility.

Pests and viruses do not restrict their infestation to selected fields. Left unchecked, they would merely spread from unprotected fields and livestock, and then infect further unprotected areas. Antibiotics are medical city walls that keep away marauding invaders, and prevent them from invading territories and conscripting the local population into their armies to do further damage.

Resistance to the antibiotics, antifungal and antiparasitical drugs used in agriculture is collectively known as antimicrobial resistance (AMR).

An independent body chaired by the British economist Jim O’Neill looked specifically at antibiotic use in the environment and agriculture. Among other things, this body examined the ways in which regulation and financial measures such as taxation and subsidies could play in reducing the risks associated with the agricultural use of antimicrobials and environmental contamination.

The data from the report suggests the amount of antimicrobials used in food production internationally is at least the same as that in humans, and in some places is higher. For example, in the US more than 70% of antibiotics that are medically important for humans are used in animals.

What does that all mean? It means that drugs normally for humans are already used in animals. If human beings consume the meat of the animals over prolonged periods, their bodies can develop tolerance to the antibiotics because they were used in the animals. If human beings later have a need for these antibodies, in the medicines for humans, these forms of medication will have little or no effect. And as we have seen before, ineffective long term medication may only create addiction to drugs and pain relief medication.

The report included peer-reviewed research articles in which 72% of the 139 articles found evidence of a link between antibiotic consumption in animals and resistance in humans. There is enough impetus for policy makers to argue for a global reduction of antibiotics in food production to a more appropriate level.

But while the evidence suggests that we should reduce the usage of these antibiotics, antimicrobial usage is unfortunately likely to rise because of the economic growth and for increasing wealth and food consumption in the emerging world.

A considerable amount of antibiotics are used in healthy animals to prevent infection or speed up their growth. This is particularly the case in intensive farming, where animals are kept in confined conditions. An infection in these confined spaces could easily spread between organisms. Further to this, some animals receive antibiotics so that natural limiters to size are killed off in order that their growth is accelerated. If you sell meat by weight, it makes sense that you try to produce as big as animal as you can so that you can maximise your profits.

The report mainly highlighted three main risks that had connections with the high levels of antimicrobial use in food production. There was the concern that drug-resistant strains could be transmitted through direct contact between humans, particularly in the case of farmers, and animals on their farm. Secondly, the transmission of the drug-resistant strains could also result due to the contact during the preparation of the meat, or the consumption of it. Thirdly, the excrement of the animals might contain the drug-resistant strains and the antimicrobials and therefore pass into the environment.

There was also concern raised about the possibility of contaminating the natural environment. For example, if factories that manufacture these antimicrobials do not dispose of by-products properly, these may pollute the natural environment such as water sources. Already we have seen that fish near waste-treatment plants, which treated urine tinged with chemicals from birth control pills, developed abnormal characteristics and behaviour.

The review made three key recommendations for global action to reduce the risks described. The first was that there should be a global target for the minimisation of antibiotic use in food production to a recognised and acceptable level in livestock and fish. There were also recommendations that restrictions be placed on the use of antibiotics in the animals that are heavily consumed by humans.

Currently there are no guidelines surrounding the disposal of antimicrobial manufacturing waste into the environment and the report urged the quick establishment of these in order that pollution of the environment could be minimised and the disposal of by-products and active ingredients be regulated.

The report also urged for more monitoring on these problematic areas in concordance with agreed global targets, because legislation without means of enforcement is useless.

Is it possible that the production of antimicrobials can be limited? One cannot help but be cynical. As long as we inhabit a world where sales drive rewards, it is inconceivable that farmers would slow down their production on their own initiative. We would definitely need legislation and some form of method to ensure compliance.

But what form of legislation should we have? Should we focus on imposing penalties for non-compliance or incentives to encourage the reduced use of antimicrobials?

Some may argue that the latter is more effective in this case. If farmers are offered financial subsidies so that they receive more money for the price of meat, for example, they would be more inclined to reduce the usage of antimicrobials. But how would these be monitored? Could the meat for sale could be tested to ensure the density of antimicrobials falls under established guidelines, for example, so that if the farrmer has been relying on the use of antibiotics to increase the size of livestock, he is latterly being recompensed for the reduction in size arising from the reduction of the antibiotics?

Unfortunately the difficulty is in reconciling both the need as well as the established economic system for growth in one hand, with the sustainability factor in the other. How is farm produce sold? When you buy a bag of salad, a cut of meat, or a bottle of milk, all this is sold by weight or volume. You may buy eggs in carton of six, but they are also graded by size and weight. For the direct manufacturer – the farmer – size, volume and growth are what bring about greater profits – although these profits may barely be just above the threshold for subsistence. And after making allowances for damage due to weather, theft, low market demand and all other variables that threaten an already low-profit industry, asking a farmer to reduce the use of antimicrobials is akin to asking him not to take measures to protect his livelihood. If the use of antimicrobials bothers you, then you have to compensate the farmer not to use them, by being willing to pay higher prices for farm products.

Why do organic or free range eggs cost twice the price for half the size? Aha!

While antimicrobials are also used on free range produce, and the case of organic farming is not entirely relevant here, the same issue is being highlighted here. You are paying more for the process than the product, and in doing so the extra payment that you make is towards the farmers for farming practices you are seeking to promote.

A farmer can get more produce by rearing battery hens, but if you are concerned over animal welfare, you pay extra per animal for the farmer to rear it with more space and hence more welfare for the animal. Your free range chicken costs more not because it is bigger, or necessarily healthier, but because it has been afforded more space, which you consider to be ethical. Farmers may switch to organic farming if there is enough demand for this, and for some this may even be more favourable, because having to produce fewer hens, but fetching the same price as battery hens, may, in the grand scheme of things, be seen by the farmer as a more favourable solution.

In trying to promote less use of antimicrobials, we have to make up the farmer’s perceived loss of earnings. So it is not incorrect to say that if we are concerned about the use of antimicrobials in agriculture, we have to pay more for our farm produce. Are you prepared to do that? For families with high disposable income, the increase may only represent a small additional fraction. But for families on smaller incomes, the increase may be too steep to be feasible. In other words, while the need for a reduction in agricultural antibiotics is recognised, in practical terms it may only remain an aspirational ideal except to those who can afford it.

Can be people be convinced – even if the cost is high – that in the long term it is better for human health? If the continued use of antimicrobials means that human medication in the future may become less effective as our resistance is tempered, should we, despite our reservations about the cost – make the leap towards maintaining a sustainable future? And if low-income families cannot afford to pay more in the cost of their weekly shop to get less, ridiculous as it might sound – should higher income earners step in to fill the shortfall?

It is strange how the wider discussion about the use of antimicrobials in society leads to a discussion about income distribution and political sensitivities.

What has arisen in the course of that evaluation, however, is the fact that expecting citizens alone to fully contribute towards the production shortfall arising from a reduced use of antimicrobials by paying more for their farm produce is not going to work. While some can afford to, many cannot, and those that can may not necessarily want to pay for those that cannot. There are also other measures to reduce the use of anti-microbials.

Governments could also introduce legislation to prevent environmental contamination through antimicrobial products and by-products, and harsh penalties for doing so. At the moment there are no rules in place, it is of increasing concern that such legislation is developed quickly.

Governments could also offer tax subsidies and support for farmers who continue to reduce antimicrobials usage. These could be introduced at the end of the first year, when farmers need most support at the initial stages of conversion, then at thirty months, and at further longer-spaced periods. Subsidies or incentives could an arithmetic progression at the end of one year, two-and-a-half years, four-and-a-half years, seven years and so on, so there is continued incentive to maintain reduced antimicrobial usage.

The only problem is, where would the money for these subsidies come from? If the government receives less tax from farm produce transactions because less has been sold, and it has also received less from antimicrobial companies in the form of tax, because it has made them limit their production, where will it make up the shortfall? Through an environment tax on its citizens?

Therein lies the problem.

The conundrum is this: the threat of antibiotic resistance in the future means we have to lower the level of antimicrobials we currently use. Yet if we do so, we are looking at reduced economic output. And as long as we have an economic system that is reliant on growth and increased production, asking to slow down production is economic suicide.

You may ask: “What about if we have a re-evaluation of an economic system, and create one that is based on sustainability?”

I am sorry to say it but that is wishful, idealistic thinking.

The problem with switching to a sustainable-based economy can be described as such.

Imagine there is a children’s party. At this party there is a table with a gigantic bowl of sweets. The children who are first to arrive eagerly stuff their faces and pockets with sweets, and as the party progresses, the bowl gradually looks emptier and emptier. The parents present chastise their kids if they continue to head for the sweet bowl, remonstrating with them to leave some for the kids who have not yet arrived from the party. Some of these children, perhaps the older ones, might reduce their trips to the bowl and the number of sweets they take. But some children will continue to plunder the bowl of its sweets before it all runs out and stuff their faces, recognising the sweets are a dwindling resource and if they want to eat them they’d best take as many as they can. And a third group, while recognising the sweets will soon run out, are equally keen to get hold of as many as they can, not to eat the sweets, but because they realise that when one of the latecomers arrives and find there are no sweets left, their parents may offer them incentives to trade to appease the desperate child. “Charlie didn’t get many sweets because he was late. If you let Charlie have two of the sweets you already have, I’ll buy you an ice-cream later.” This third group recognises not just the impending scarcity, but contribute to it by stockpiling their own resources to use for later leverage. And they may even make the loudest noises about how everyone should stop taking sweets, only so that they can make the biggest grabs when no one is looking.

Who are the losers in this situation? The obvious ones are the one who arrived late at the party. But the not so obvious losers are the ones from the first group, who amended their behaviour to ensure that there were still sweets left for the later groups to come. In being principled, holding on to ideals, they became lesser off materially, and the only consolation was the knowledge they had made the effort to leave some sweets for the late group – whether or not the latecomers actually got any or not is another question. The sweets ran out eventually.

The problem with thinking about sustainable economic measures is that the first to make an attempt to switch on ethical or aspirational grounds will be among the ones to lose out, because subsequent groups will still make a grab for whatever is left. Some will make a grab to get as much of the remaining resource, while others will make a grab so that when there is scarcity – and scarcity drives up prices – they have plenty of the resource to benefit. So while everyone is making the right noises about economic sustainability, everyone is just holding back for someone to make the first move.

So this is what antibiotics in agriculture really tells you: Too much can create problems later due to antibiotic resistance and improper disposal. We need to cut down on the use of antimicrobials. But reduced antimicrobials means reduced output, and we must be prepared to pay higher prices for less produce to compensate the farmer for that to work, in order that they may earn a living. The government can introduce penalties to govern the disposal of antimicrobial-related products to limit the damage on the environment alongside incentives to limit the use of antimicrobials. But it will have problems funding the incentives. Because what it is proposing is economic slowdown, in order to have an economy at all in later generations – but the current generations are too concerned with their own interests and survival, and stealthily making a grab for the remnants after the first few leave the economic arena.

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.

Where Will factors in mental health treatment

If medication is a physical stabiliser, is therapy a mental stabiliser?

If you’ve read the last few posts you might have come to the conclusion that as far as mental health is concerned, the line of thinking contained in this blog is that an approach that is suitable for long-term and lasting treatment is part medication and part therapy. Medication initially works best for more serious cases, and milder forms of mental health illnesses may be possible without the use of prescription medication, but for the long term, it is better to wean patients off the medication. Not simply because the use of medication over longer periods breeds addiction, dependency and causes changes to the body which may be harmful, but for the health service, it is an unsustainable form of treatment that simply continues to deplete the environment of its resouces while contributing to climate change and extreme weather. It seem strange to have to mention climate change in a medical blog, but essentially this is what we can trace it back to.

Medicine, especially for serious cases of mental health, is an effect-suppressant that minimises immediate symptoms while buying time for alternative therapies that promote long-term solutions to kick in. But there are those who consider if medication if even neccesary at all. After all, the body does a pretty good job of healing itself when we get cuts. Those who ascribe to this view hold that given time, the body does what it needs to prepare itself for survival and growth.

The only problem that time is not always an available resource. Sometimes we need results in a short space of time, and do not have the luxury of seeing the effects of mental illness dwindle away over years. Medication provides a higher level of immediacy to treatment. To some, it seems that medication is flooding the body with chemicals it could obtain or manufacture from within, but within a shorter span of time and with a higher concentration. It is giving the body what it needs in an intensive period rather than over a longer span of time that the non-medical proponents advocate.

Some go further to suggest this no-medication approach can be extended to the therapy aspect of mental health treatment. They argue that therapy, counselling or any other cognitive methods of treatment only serve to increase stresses rather than decrease them. While no one would ever advocate a completely non-medicated and non-therapy treament for mental health illnesses, and the current thinking is a part-medical and part-therapy approach to mental health illnesses, there are those who might consider a non-medicated but supported therapy approach. Another variant of this is the medicated but no therapy group. It is this last group which we will consider further.

On the face of it, it seems preposterous to even suggest it. If we have believed that mental health illnesses can only be treated in the long term with therapies such as counselling, then how is it even possible to consider a zero-therapy treatment group?

Proponents of the above idea hold that the therapy causes stress rather than deals with it on a long term basis. What patients really need, it is argued, is mental space to dwell on their lives, reflect on how they are living, then in order to make long-term changes, they have to find solutions within themselves and the will to apply them. Methods such as counselling and cognitive therapy already exist, but as the solutions are arrived at through the meetings within the counsellor and patient, it is felt that certain patients may only view the changes they have to make as being dispensed by the counsellor, and see them as extrinsic factors. Hence the guidance may be less effective. However, if they are given time and space to reflect on what they need to do, having examined their situation in detail for themselves, it is one that they will be more effective in finding the will to put actions into practice.

Take for example, the caterpillar. Cocooned in security, it makes minute adjustments day by day to prepare itself for the life ahead. To the outsider it looks as if nothing is going on, but this could not be further from the truth. As it is about to break out and emerge as a butterfly, it has to struggles and somehow bridge the gap from where it is, to where it must be. The final trials, as it tries to break out from the cocoon actually help to strengthen and develop its wings permanently. Maturity is arrived at without any extrinsic factors. The caterpillar made it on its own. If someone had helped it, perhaps by thinking to widen the gap through which it must emerge, the lack of pressure and resistance would actually cause the emerging butterfly to have weaker wings and have a poorer chance for long-term survival.

Those that point to a no-therapy solution claim that the guidance of the counsellor, psychotherapist or assisting care individual actually puts a timeframe on what could actually be a non-hurried adaptive process of the mental health patient. A counsellor is paid, either through the mental health patient directly or from a health service. The presence of a counsellor may only impose a time-limit by which progress must be made because health care funds will run out, or perhaps accountability demands that the patient make progress at a speed that may not be concordant with the natural run of things. The pressure to be at a certain mental stage in time may only impose an additional counter-productive burden in the first place.

A common factor in depression is the dwelling on the gulf that exists between where one is and where one wants to be. The prolonged over-emphasis on the disconnect between both disparate worlds is one of the reasons why individuals develop unhappiness and long-term depression. Yet the argument could be made that counselling and cognitive therapy, while aiming to bridge that gap, may not be effective in helping patients develop the skills and will to bridge the gulf in order to take their development forward. Often the development has to follow the patient’s natural timing and pace, and if this important counselling cornerstone is disturbed, then the advice and guidance received from the counsellor will merely be more pieces of information dropping into the gulf and  widening it further.

Some point to a period of reflective solitude as the necessary key to a long term solution. The individual goes at a pace he is suited to, slowly adapting to the needs of his situation and developing the skills for long term recovery. A self-monitoring form of silence and meditation is imposed. The theory behind this thinking could not be any more different from traditional approaches. Where traditionally some form of intervention might be applied to, say, an individual lying in bed and unable to face the day ahead, either through the dispensing of advice such as “Man up! Toughen up!” or visits to therapists, proponents of the reflective solitude theory view the process as the individual resting himself in preparation for the changes ahead, akin to the caterpillar. The belief is that the mere thought of an activity triggers physical processes in the motor nerves, so by resting, the individual is clearing his mind and soul and preparing his body before he can fill it with more useful purpose. It is not a major problem that the resting may  take place over a period of weeks. But the belief is that ultimately the individually will feel compelled to make some changes to better his situation, and the will to do so will have been found.

To take the argument further, and possibly to an extreme, does therapy perform only the role of a distractor or mental substitute? While medication performs the function of a physical stabiliser, does therapy perform the role of a mental stabiliser, stabilising the mood swings and thoughts of the affected individual, before Will, binding these altogether, prompts the individual to leap across the gulf between “where I am” and “where I want to be”?

If you believe that real, long-lasting change can only come about when the mind and body are relatively stable, and given time, an individual posseses the inherent power to heal themselves of mental illness and free themselves from the shackles of the likes of depression, then you might make the case that therapy isn’t as important as it is cut out to be. Is therapy really necessary in this case, and can it be replaced by recreational interests, for example, where parts of the brain that are latent come to the fore, and override the parts of the brain that trigger mental illness?

It would be simplistic to find a direct link between mental health and recreational interests or hobbies. Hobbies do not directly cure mental illnesses. But what they can possibly give is a sense of achievement and empowerment to an individual, subtly developing the mindset and will that change can be attained. The subtle aspect of development is an important one, it is an indirect way of going about developing achievement and staying hidden until the affected individual one day surmises his development and can see measurable progress that could spur him on to make great strides in matters of more concern. If, for example, a mental health sufferer takes up a hobby, such as learning a musical instrument like the piano, the time and energy invested into this may draw excess energy and time away from that invested into unnecessary mental worry, resulting in a greater sense of overall well-being.

How long-term medication harms – but why nothing may be done about it

In looking at mental health, we have previously examined the idea that while medication offers short-term relief, long-term change is brought about through lasting measures such as cognitive therapy. We have also seen that medication is more effective in individuals with more severe forms of mental health, while milder forms can also be dealt with through non-medicative measures. We can summarise by saying that the role of medication is to offer immediate relief, but over a long term, to stabilise the individual to a state where pressures or stressors can be managed to a point where they do not cause stress, but give the individual opportunity to live with them, while examining the root cause of their problems.

The underlying causes are usually non-medically related; they can be extrinsic factors such as the working enviroment or lifestyle. Medication is hence insufficient to deal with these because they cannot impact on them. The focus on the root of the problem is one that patients on medication need to ultimately address. Unfortunately patients taking prescription medicines often make the assumption that if a certain pharmaceutical drug has been prescribed to address a particular problem, then more of it, even within limits, can eventually help resolve it. That is only a mistaken assumption. Overdosing on medication does not address the root of the problem. It only lulls the body into a relaxed state, blinding us to the immediate surroundings, so while we feel calm, relaxed or “high”, this feeling is only temporal.

Medications and the prescription of medication are reactive, not proactive. They treat symptoms that have manifested, but do not treat the cause of the symptoms.

These views of medicine are not just limited to mental health problems; they can extend into physical realms. Take eczema for example. A doctor may prescribe creams containing hydrocortisone and paraffin for you to manage the itchy, red flaring skin conditions that usually see in eczema sufferers. However, these creams may only offer you temporary relief. As soon as you stop taking them, your eczema may return. Advocates of TCM, or traditional Chinese Medicine, suggest that eczema results from an overactive liver, and the trapped “heat” in the body, when it is seeking release, manifests itself as flared red patches over the skin. Creams such as paraffin or other barrier creams may be viewed actually as being counterproductive, because they only prevent the internal heat from escaping and make the eczema worse. Have you ever encountered anyone who, upon applying the cream for ezcema, reported it only worsened the itch? If you visit a TCM practicioner, you will probably be prescribed a cream with some menthol formulation for external use, oral medicine for your eczema, and the advice that in order to deal with the root cause of your eczema, you have to make changes in your diet – specifically, not to over-consume food such as fried food or chocolate, and to avoid alcohol and coffee.

It would be great if the immediate and short-term relief brought about by medication could be extended for long periods. If you were suffering from serious illness such as severe depression, the difference you feel would be very noticeable at the onset of medication. However, medication is only a short-term stress suppressant, buying time in order for longer-term (usually non-medical) measures to take effect. It is not the intention of any prescriber – be it a GP or pharmacist – that any patient be on medication for a prolonged period of time. While it might be good financially to have such patients, it is unethical to keep patients unwell to have a constant income stream and a source of revenue. In this situation the health of the patient has become secondary to the financial benefit he or she can bring, and it is against the ethics of the medical profession.

It is unwise to be on medication for long periods. First and foremost, the body adapts to the doseage and in time the effects that the medicine initially brought are diminished, to the point that either a higher doseage of the medicine is required, or the patient is switched to another new type of medicine which is more potent. In both cases, if medication is seen to be the cure, rather than just to buy immediate relief, then the patient will merely keep taking the medicine in the hope that one day it will completely cure his or her problems, and the potential for addiction to a higher doseage results. This is how all addiction begins, and it is unfortunate if patients who take medication find that it has not only dealt with their initial symptoms, but layered it with a secondary problem of addiction to painkillers.

Addiction is only one of the problems brought about by use of long-term medication. There is the possibility, too, that the body also adapts to new chemicals and is slowly malformed. But the negative impact of medication remains unnoticed until it reaches the tipping point and consequences are made apparent with a catastrophic event. With smoking, for example, constant exposure to the chemicals damages the lungs and malforms them, but often people only sit up and try to take corrective action when irreparable damage has set in and lung cancer has developed. Medication is on the opposite end to the scale as smoking and is taken at the onset to cure rather than harm, but it has the potential to change the human body when taken over prolonged periods.

But the changes are not necessarily just experienced by patients on medication alone. Research scientists from the University of Exeter found that, for example, certain species of male fish were becoming transgender and displaying female characteristics and behaviours, such as having female organs, being less aggressive, and even laying eggs. The fish had come into contact with chemicals in water near waste-treatment plants. Chemicals contained in birth-control pills, mixed with urine flushed down the toilet, were cited as a particular source of contamination.

Long term medication is also not a good idea for children. If hyperactive children are embarking on activities that require focus such as school, or piano lessons, it may not be a good idea for them to be on prolonged medication. It may be better to treat the underlying causes first, to teach the child management strategies, rather than to merely treat the outwardly present effects.

When it comes to mental health problems, the best approaches are a mixture of medication and therapy. Give that medication is meant to be short-term, it is hence, important that therapy be as effective as possible in order for patients to entrust it to fully healing them, rather than depending on medication. This is of course more appropriate in instances of mental illness rather than physical illness that involve pain-relief. Nevertheless, in the latter case, where medication is for physical pain relief, some have suggested therapies such as hypnosis and acupuncture as long-term substitutes for pain medication.

It is worth the NHS examining such therapies in order to study the scientific evidence behind them, to glean any insight that could either be applied elsewhere to other treatments, or to find more cost-effective, longer-lasting treatments that will contribute to the NHS being a sustainable health service. Already, at the present time, the current model of the state being a mere provider and source of medicines and advice to its citizens cannot carry on. The cost of patient care will rise and drain its resources, and it would be more cost-effective to spend resouces to encourage citizens to actively take responsibility for their own health, and hence lessen the burden on the health service, rather than merely look towards it as a provider of medication.

There are also other reasons why the NHS has to prime itself for a move towards being a sustainable health service. It has to limit its carbon footprint in order to minimise the impact it has on the environment.

The prescription of long-term medication can ultimately have its impact traced back to the environment. Constituents of medication are either obtained from natural ingredients from foods grown on land, or manufactured in factories, which again, commandeer land use. The process of turning them into medication requires power and electricity, which either use up fossil fuels and produces fumes and greenhouses gases that result in global warming and instances of extreme weather, or renewable energy in the form of wind farms that still use up land, or solar energy from solar cells whose manufacture might have been through unsustainable means. Waste from manufacturing processes, or from the manufacture and the disposal of the medical product enters landfill or pollutes natural resources.

Land is a limited resource. More specifically, land that can grow useful crop is a limited resource. And so even if the current level of pharmaceutical manufacturing remains the same – perhaps, by some freak balance where the number of people being newly prescribed medication is equatable to the number of deaths – the land, along with the space available for landfill can never be refreshed on that basis. It might not make an immediate difference to you, but every individual has a civic responsibility, as a global citizen, to preserve the earth to make it habitable for future generations, to avoid killing off the human race.

Essentially, we need to lower our dependency on medication to avoid this impact on the environment. So that future generations have a habitable environment.

The problem is in convincing pharmaceutical companies to embrace this thinking. These companies depend on sales and if sales were to fall, so would profits and the price of shares. Pharmaceutical companies are accountable to their shareholders, and need to raise their share prices and create growth. The moment they start thinking about sustainability, they are looking to reduce their growth, and their share price would stagnate. Would you invest in a company with stagnant growth? Thought not. And if a company reports less profit, the government would have raised less revenue through tax and has to make up the shortfall somehow.

Being on long-term medication harms the body, among other things by creates changes in the body and fostering dependency. Ultimately it has significant bearing on the environment. The challenge is for us to wean ourselves off long-term medication, only using it in the short term while we address the root causes of our problems through therapy. On a wider scale, we need to create new business models because current ones actually depend on a sizeable number being unwell, in order for the economy to function. Surely that last statement is not ethical in itself and must raise incredulity – that in this day and age we are not trying to heal people, but maintain a threshold of well and unwell people that is economically beneficial!