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.

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.

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!

Red wine – the media’s Wonderdrink

If there is anything to be said about the British media, it is that it seems intent to make a superhero or villain out of the common everyday foods we encounter. Every now and again we are presented with small-scale research on food or drink that promises either a miracle cure or a dangerous red flag. One assumption peddled to us is by continuing to consume the food, we will either gain added health benefit without too much effort. Miracle cure just by eating! The counter to this is the article written to warn against continued consumption. Danger food – consume carefully! You are either a superhero, or a villain in the world of miracle foods.

It is safe to assume that the purpose of these articles is ultimately to hook the reader into buying the newspaper to examine the article further. And if it appears on an online version instead, you can be sure that the intention is to keep the reader glued to the page while paid-for advertising revenue flashes on the side panels. To state it cynically, the purpose of these articles is for sales. It might be long before certain foods such as milk might purportedly be the cure to cancer.

We need not spend too much time judging how effective these media reports are. If you are looking to a newspaper as a reference for health advice, you might as well ask about ballet lessons from the petrol station.

One of the poster children for miracle foods is red wine. Depending on what you’ve read, red wine can:

  • Boost immunity
  • Prevent tooth decay
  • Save your eyesight
  • Be good for the heart

But it won’t help you in the fight against diabetes, or help you lose weight. Was worth considering, though.

One of the latest research into red wine studied if, yes, it could find the ageing process. A US study suggested resveratrol, a substance found in the skin of red grapes, may help keep our muscles and nerves healthy as we get older.

Researchers gave mice food containing resveratrol for a year, then compared the muscle and nerve cells of those mice to cells from mice the same age who’d had a normal diet. In the mice who’d had the resveratrol-enriched diet, they found less evidence of age-related changes.

The researchers also looked at another chemical, metformin, but found it had less effect.

Researchers divided laboratory-bred mice into four groups and fed them either:

  • a normal diet
  • a lower calorie diet from four months of age
  • a diet enriched with resveratrol from one year of age
  • a diet enriched with metformin from one year of age

When the mice were aged two years, they looked at their muscle and nerves, at the meeting point of the two (the neuromuscular junction, or NMJ) in a leg muscle. They also looked at the NMJs of three-month-old mice to see how they compared to the older mice.

Compared with mice fed a regular diet, those who’d been given resveratrol or who’d had a calorie-restricted diet showed:

less fragmentation of tissue at the neuromuscular junction
fewer areas where the nerve cells had degenerated, which would have meant that the muscle no longer had input from nerves

The two-year-old mice which had calorie-restricted diets had neuromuscular junctions that were most similar to the three-month-old mice. Metformin had little effect in this experiment.

The researchers say that this indicates less ageing as muscle fibres increase in size with ageing. But this does not suggest if the ageing was beneficial or not to the subject.

Resveratrol has been of interest to anti-ageing scientists for many years and researchers have previously shown it may be linked to a slowing of the decline in thinking and movement, at least in rodents. This study suggests a possible way this might happen.

But the results don’t tell us anything about what happens in humans. They suggest this substance may be useful for further research in humans at some point. They certainly don’t provide a reason to drink gallons of red wine, in the hope of seeing an anti-ageing effect. Drinking too much alcohol is a sure-fire way to speed up deterioration of thinking skills, and can cause brain damage. Too much alcohol in the long term is linked to several cancers, heart disease, stroke and liver disease.

Although red wine contains resveratrol, the amount varies widely, from around 0.2mg to 12.6mg per litre. That’s nothing like enough to get the amounts consumed in this study.

The mice were fed 400mg of resveratrol per kilogram of body weight each day. To achieve the same level of anti-ageing purported in the study, the average weight woman in the UK (around 70kg) would need 28g of resveratrol a day for the same effect. This would be obtained by consuming more than 2,000 litres of the most resveratrol-rich wine. An average weight man would need even more. This would be going beyond side effects and into the realm of health dangers! Or if you were disturbed by the daily consumption of this amount of alcohol, and still wanted to try, you could eat bin loads of berries – you might need fifty of these a day. What’s for breakfast? Blueberries. Snack? Blueberries powerbar. Lunch? Blueberry soup? Dessert? Blueberry cake. Resveratrol occurs naturally in the skins of some red fruits, including some grapes, blueberries and mulberries. But this rate, anti-ageing might be more of a curse.

The study was carried out by researchers from Virginia Tech, Roanoke College and the National Institute on Aging, all in the US, and was funded by the National Institutes of Health.

Is there any thing of value we can glean from this research? One certainly hopes that the whole research was conducted for more significance than mere paper filler.

The effects of rosveratol will probably hold the most interest for researchers. One can imagine that scientists will be looking to produce genetically-modified grapes that hold more of the chemical, or refine the chemical until it reaches higher levels of purity. Drugs, medication, and anti-ageing creams may contain higher levels of rosveratol. Why is there the interest in slowing down ageing? It extends beyond the obvious physical aging. Slowing down the process may also inhibit age-related diseases such as cancer, diabetes, Parkinson’s and dementia.

And while it was of little effect in this particular trial, metformin is currently undergoing trials as an anti-ageing drug. While it is one of the drugs used in the treatment of type 2 diabetes, and marketed under brand names such as Glucophage, it is relatively new as an anti-ageing drug.

Belgian researchers researching metformin found it increased the number of oxygen molecules released into a cell. When tested on roundworms, the worms aged slower, did not slow down, nor develop wrinkles. They grew stronger bones and increased their own lifespan by nearly 40%.

Metformin only costs only 10p a day which means it falls well under the threshold of QALY (quality-assisted life years) cost that the NHS uses to measure cost-effectiveness. It is conceivable that either metformin or rosveratol could form the active ingredient of anti-ageing pills or creams in the future.

And when that happens, you can read all about it in the papers again, about how red wine really lengthens your lifespan! You might even want to sign up for a clinical trial!

The British media is really drunk on red wine.

Mental Health Medication – Concerns and Ethics

One of the most common questions about mental health problems is whether people need medication to deal with them, or whether they can be simply dealt with through therapy. Mental health problems can range from the not so severe – such as mild anxiety – to more severe problems like long-term depression. There are some that see medication as a short term, quick fix solution – it will give relief fast, but it doesn’t really teach one to deal with the heart of the problem – hence the suggestion of therapy and counselling. Yet there are those that remain convinced that while therapy re-educates the patient and deals with mental health difficulties on a long term basis, sometimes medication provides a greater level of immediacy in providing a solution, that its role cannot be denied. Should I take medication for _______” is one of the most frequent queries received. The ideal solution is probably a combination of medication and therapy, whilst gradually reducing the level of medication and therapy as the patient progresses.

Medication can be useful. For example, for those with paralysing anxiety, medication can minimise the stress and anxiety placed upon an individual by these stressors until the level of anxiety is at a comfortable and manageable level, enabling one to live their daily life while keeping their anxiety at a level they can control. However, for individuals with a severe mental health condition such as schizophrenia, the use of medication may be necessary in order to attain a level of mental stability and hence safety.

But medication is not just for a stabilising calm influence. For those, however, for whom facing the day is a burden, and who remain unable to get out of bed in the morning because depression has stolen all motivation, mental health medication can provide a jumpstart, an impetus to face the day. Certain people may benefit from taking psychotropic medication. For example, a study funded by the National Institute of Mental Health found that some individuals who were prescribed the selective serotonin reuptake inhibitor (SSRI) Paxil, because they experienced moderate to severe depression, experienced positive changes in mood, together with significant improvements in depressive symptoms. There was a marked decrease in the level of neuroticism and a similar increase in extroversion. These effects occured over a period of eight weeks and were nearly equivalent to the changes most adults experience in the course of a lifetime.

According to Maslow’s hierarchy of needs, human beings must satisfy more basic needs such as food and shelter before they attend to more self-actualising needs. It is difficult for most people to focus on avenues of self-growth when they are in crisis or struggling with anxiety, depression, or other mental health conditions. In some cases the polarisation can even lead them further into depression. In this instance, medication can support the psychotherapy process, and a stabilised person can progress further in psychotherapy having had the needs at the lower end of the hierarchy addressed. For example, a study published in the Journal of the American Medical Association shows that cognitive behavioural therapy combined with targeted medication tends to lead to significant improvement of attention deficit hyperactivity symptoms in adults. And in the long term, of course, a common outcome of successful psychotherapy is the reduction or elimination of the need for medications, so medication can be viewed as a temporary measure.

And while we have to recognise its benefits for the short term, we have to realise that medication can be harmful for some individuals if taken over a prolonged period. Most, if not all, drugs come with potential risks and side effects. Some can be minimal and tolerable while others carry disadvantages best considered as trade-offs. The side effects range from physical ones to emotional and psychological ones. Physical side effects range from dizziness, drowsiness, or changes in appetite, and/or weight gain. Emotional and psychological side effects may range from mood swings, disinterest in activities, or emotional numbness and a lack of empathy. Prescribed over a long term, antipsychotics may cause permanent damage by leading to conditions such as tardive dyskinesia or Parkinsonism, and may even cause death. The death may not be triggered by physical caused, but by mental irrational thinking. A 2005 article in the Harvard Mental Health Letter spelt out in detail the increasing awareness of risks associated with SSRI antidepressants, such as a potential increase in suicidal thinking and behaviours for adults and children under 24 years of age. One could, however, speculate if the suicidal thoughts were triggered by the medication directly, or whether it was the prospect of lifetime medication without an apparent cure that caused these feelings of hopelessness. Whichever you look at it, it is fair to say that there are people who will benefit from taking these medications, but also people who may experience lasting harm as a result of antidepressant use. The use of medication remains a double-edged sword.

But there are lines of thought that ascribe that medication is not always a necessary process. While medication may be effective for treating certain conditions, researchers at the University of Pennsylvania and Vanderbilt University suggested that, over a period of 16 months, cognitive therapy was a more effective means of preventing a relapse into depression than antidepressants alone. Research findings published in the Journal of the Amercan Medical Association found that while antidepressants were helpful for those experiencing severe depression, milder to moderate forms of depression derived more benefit from other treatment options, such as therapy. A 2010 article published in Newsweek arrived at the same conclusions, suggesting that, for some individuals, antidepressants are little more than a placebo.

To summarise what I’ve said so far: mental health is best addressed through a combination of therapy and medication. Severe forms of mental depression, which require more immediate intervention, would benefit from prescription drugs and therapy, while therapy alone may be sufficient enough for milder forms. Medication provides short-term benefit, especially in higher forms of depression, but we must be cautious over its long-term use because it can have side effects.

Medication can interfere with the emotions as well as the psychotherapy process. One of the most common side effects of psychotropic medication is difficulty feeling certain emotions, perhaps even a lack of empathy, once enough doseage of a drug accumulates in a person’s system. When we consume too much of a drug that is meant to limit our nerves, for example, many people complain of losing the feelings they used to have, report a reduction in their ability to laugh or cry, or experience a decrease in libido. These are the effects of medicines with a calming influence. Other side effects extend to one’s sexuality and love relationships, such as diminished sexual interest. Medication can also limit hyperactivity in the brain, acting as an emotional relaxant, but this slows emotional processing for some, and in doing so, covering up underlying issues and causing the psychotherapy process to be slowed down. A possible consequence of taking too much medication and becoming numb to feelings is the increased likelihood that a person will not become conscious of the emotional or somatic burdens which can cause of stress and suicidal feelings. It may be stretching things a little, but if you view medication as a substance, just like we view alcohol – too much consumption leads to physical health problems, as well as a capacity for clear thought processing – we can get a better idea of how the prescription of medication might not always be a clear-cut issue.

Proponents of a little- or no-medication approach to mental health point out that many emotional and mental health issues are not reducible to a biochemical imbalance. Life events — what happens to and around us – can impact on our mental health, and because medications do not change how people relate psychologically to their experiences, medication alone cannot “fix” all psychological issues. In fact, the temporal masking of life circumstances by medication is probably what induces people to overdose in the first place, taking more medication to completely obviate one to one’s surroundings. Treatment with medication alone can be like stitching up a bullet wound without taking the bullet out first – dealing with the effects without dealing with the cause. It is one of the main criticisms of the medical profession.

Furthermore, an over-simplification of what causes depression has led to the development of anti-depressant drugs that are actually designed to treat or minimise stress. These medications are often of little use because they have been tested on animals, and for the laboratory animals such as rats chronic stress does not cause depression. Psychotherapy, on the other hand, is often able to discover and treat some of the mental health issues that may contribute to depression, such as psychological trauma and anxiety. For example, a 1995 Consumer Reports study shows that some individuals experiencing mental health issues were significantly helped by psychotherapy. The study found that long-term therapy had, in general, the most beneficial effect, and that treatment with therapy alone was no less effective than treatment with medication and psychotherapy.

In an article “Mind over Meds,” which appeared in a 2010 issue of The New York Times Magazine, Dr. Daniel Carlat, a psychopharmacologist, found that the individuals he treated responded better to a combination of treatment with psychotherapy and medication together than they did purely with medication alone. The provision of counselling in addition to medication helped them to be better able to understand the true nature of their concerns. His findings are supported by research that therapy can stimulate the growth of neurons and synaptic connections between neurons. However, medication for depression, anxiety, and other emotional problems do not stimulate the brain; instead they dampen the brain’s mental activity. Therapy is capable of healing core problems and facilitating long-term changes, and why medication alone cannot. But medication is important in areas where the mental thoughts of the individual needs to be reduced to a lower level of activity.

Psychotropic drugs are prescribed to treat a variety of mental health issues when those issues cause significant impairment to healthy functioning. They work by changing or balancing the amount of important chemicals in the brain called neurotransmitters. The reduction or increase of neurotransmitters such as dopamine, serotonin, and norepinephrine have shown better mood improvements in some individuals. The ideal s to achieve a tolerable balance of these chemicals in order for the individual to attain a healthy life. Psychotropic drugs are usually prescribed by a psychiatrist, a psychiatric nurse practitioner (PMHNP), or a primary care physician

According to the WHO, one in four individuals will experience a mental health issue at some point in their lives. Depression and anxiety are among the most common issues, and these issues can affect people regardless of age, gender, ethnicity, or background. Researchers cannot point to the triggers of mental health impairment, but they can be attributable to environmental factors, genetics, traumatic events or serious injuries and result in psychological symptoms that persist for years.

As we have seen before, for some individuals psychotropic drugs are often not enough are best used as a supplement, and not a replacement, to therapy. Social support from family and friends, structured therapy, lifestyle changes – all leading to a change of environment – can all be important factors in the recovery process. But in some severe mental health issues may require inpatient rehabilitation before the person experiencing them can return to everyday life.

Certain individuals who are prescribed psychiatric medications may prefer not to take them, or they find that these medications do not improve their symptoms enough to outweigh any side effects or risks. Before you take any medication, it is always advisable to speak with your GP or seek specialist advice.

One major cause of concern regarding mental health and medication is the practice of prescribing medications that were originally developed for adults to children. The increase in diagnoses of psychiatric conditions in children – bipolar in particular – has led to an increase in the amount of children who take psychiatric medications. Many of which have only been fully tested in adults, and children take them in smaller doses, but the long-term impact of medication, as well as the effect on children who have yet to reach puberty needs to be examined.

Several different types of medications are used to treat mental health conditions. These include antipsychotics and anti-depressants.

Antipsychotics: These medications are most often prescribed for the treatment of psychotic issues such as schizophrenia. These drugs fall into two categories, typical and atypical antipsychotics.

The brand name is listed first, and the active ingredient is in parentheses.

Typical antipsychotics include:
Thorazine (chlorpromazine)
Trilafon (perphenazine)
Stelazine (trifluoperazine)
Serentil (mesoridazine)
Prolixin (fluphenazine)
Navane (thiothixene)
Moban (molindone)
Mellaril (thioridazine)
Loxitane (loxapine)
Haldol (haloperidol)

Atypical antipsychotics include:
Abilify (aripiprazole)
Clozaril (clozapine)
Geodon (ziprasidone)
Risperdal (risperidone)
Seroquel (quetiapine)
Zyprexa (olanzapine)

Antidepressants are a broad category of psychotropic drugs used for treating depression. There are several different classifications of antidepressants:

Selective serotonin reuptake inhibitors (SSRIs): These medications gradually increase the amount of serotonin, a neurotransmitter, in the brain. Common SSRIs include:

Celexa (citalopram)
Lexapro (escitalopram)
Luvox (fluvoxamine)
Paxil (paroxetine)
Prozac (fluoxetine)
Zoloft (sertraline)

Monoamine oxidase inhibitors (MAOIs): A less common variety of antidepressant drugs, MAOIs are often a last option with complex, treatment-resistant depression. Common MAOIs include:

Emsam (selegiline)
Marplan (isocarboxazid)
Nardil (phenelzine)
Parnate (tranylcypromine)

Tricyclics (TCAs): These older antidepressant medications have been pushed to the sidelines by newer, generally safer medications. Still, some people do not respond to the new antidepressants, so TCAs may be prescribed. Tricyclic medications include:

Anafranil (clomipramine)
Asendin (amoxapine)
Elavil (amitriptyline)
Norpramin (desipramine)
Pamelor (nortriptyline)
Sinequan (doxepin)
Surmontil (trimipramine)
Tofranil (imipramine)
Vivactil (protiptyline)

Selective norepinephrine reuptake inhibitors (SNRIs): These medications work by slowly increasing the amount of norepinephrine in the brain. Common SNRIs include:

Pristiq (desvenlafaxine)
Effexor (venlafaxine)
Cymbalta (duloxetine)

Antianxiety/antipanic medications: These medications are used to treat a variety of chronic and acute anxiety issues, from generalized anxiety to panic attacks. Antianxiety and antipanic medications on the market include:

Ativan (lorazepam)
BuSpar (buspirone)
Inderal (propranolol)
Klonopin (clonazepam)
Librium (chlordiazepoxide)
Serax (oxazepam)
Tenormin (atenolol)
Tranxene (clorazepate)
Valium (diazepam)
Xanax (alprazolam)

Stimulants: Typically, stimulants are prescribed to people with attention-deficit hyperactivity (ADHD). They help regulate disorganized thought processes. Psychomotor stimulants include:

Adderall (amphetamine and dextroamphetamine)
Dexedrine (dextroamphetamine)
Ritalin (methylphenidate)

Mood stabilisers: This category of psychotropic medication is typically used to treat intense, repeated shifts in a person’s mood, which may be common for those experiencing bipolar, schizophrenia, or borderline personality. Many mood stabiliser drugs are also commonly categorized as anticonvulsant medications.

Lamictal (lamotrigine)
Lithium

In 2013, the most prescribed psychotropic drugs in the United States (with the number of prescriptions written during the year) were:

Xanax (alprazolam), 48.5 million
Zoloft (sertraline), 41.4 million
Celexa (citalopram), 39.4 million
Prozac (fluoxetine), 28.3 million
Ativan (lorazepam), 27.9 million
Desyrel (trazodone HCL), 26.2 million
Lexapro (escitalopram), 24.9 million
Cymbalta (duloxetine), 18.6 million
Wellbutrin XL (bupropion HCL XL), 16.1 million
Effexor XR (venlafaxine HCL ER), 15.8 million

Should one be dismayed by the number of prescriptions in a YEAR alone, as well as the various types of medications available? However you feel about them, they all point to mental health as a significant issue, one that we cannot ignore. We have, however, to cautiously consider that medications that seem appropriate at this time may not be at a later stage. Ultimately, it is best that we learn to function without additive medication in the long term, not just because of their side effects – but if we are being cynical, under pressures of financial cost, medical research may in time suggest that certain forms of mental health medication were inadequate in the first place, and if funding is withdrawn patients may find themselves dependent on medication that they have to make their own provisions for – or worryingly, do without.

And it would be unfortunately ironic if the concerns over provision for mental health became another life stressor.

Beta blockers and their impact on heart attack sufferers

 

Recent research suggests that the prescription of beta blockers for heart attack patients may not have the benefit ascribed to them.

In the UK, the prescription of beta blockers is routine for patients who have had a heart attack. There are two categories of patients – those who have had a heart attack, and those who have had a heart attack with heart failure, the latter of which is the more severe case. A heart attack involving heart failure is a complication in which the heart muscle has experienced damage and where proper function is compromised.

Beta blockers work by reducing the activity of the heart and lower blood pressure. In essence, the pressure on the heart is lessened by a reduced demand on it.

Current guidelines recommend that the first group of patients are prescribed beta blockers, while for those in the second group, who have experienced heart failure, beta blockers are mandatory.

The research investigated the effect of beta blockers on the first group, for whom beta blockers are recommended but not compulsory. The findings suggested that 95% of patients in the first group did not experience a significantly longer life span and beta blockers did not have any significant impact. There was no statistical difference in death rates within a year large enough to attribute to any positive impact of the beta blockers.

As the data involved tracking a very large sample size of 179,810 people, the results could be deemed to be fairly accurate.

So what the ramifications of this research?

The first is that the vast majority of the first group of heart attack patients are being over-prescribed beta blockers. Beta blockers, while reducing the workload of the heart, can induce side effects such as drowsiness and fatigue as a result of lower blood pressure. Patients may be experiencing these burdens on their health unnecessarily.

The second issue is that over-prescription causes an unnecessary burden on the NHS if it is prescribing drugs unnecessarily. Imagine a patient who has just had a heart operation. While he or she is recuperating in hospital, beta blockers are prescribed as part of the medication. Multiply that by over 100,000, and the result is an unnecessary annual cost to the NHS if the drugs that are needless and have no impact.

Furthermore, the use of drugs with no apparent benefit can, in the long run, only weaken the body’s immunity.

The findings of the survey, however, do not reflect on the impact of beta blockers on the second group of patients – those who have had a heart attack involving heart failure. Another outcome of the findings was the suggestion that treatment be more personalised in order to locate and target patients in the first group who would benefit from the prescription of beta blockers for heart attacks which did not involve heart failure.

Beta-blockers are prescription-only medicines, commonly referred to as POMS, which means they cannot be obtained over the counter. They must be prescribed by a GP or pharmacist. They work by blocking the action of hormones like adrenaline in order to reduce the activity of the heart.

Examples of commonly used beta-blockers include:

  • atenolol (Tenormin)
  • bisoprolol (Cardicor, Emcor)
  • carvedilol metoprolol (Betaloc, Lopresor)
  • nebivolol (Nebilet)
  • propranolol (Inderal)

The generic name which contains the active ingredient is named first, the brand name is in parentheses.

There are many types of beta-blockers and they may be used to treat symptoms such as angina, heart failure, atrial fibrillation (irregular heartbeat), heart attack or high blood pressure. Those are the more common uses of beta-blockers, also they can also be used for migraine or to treat an overactive thyroid (hyperthyroidism), anxiety, tremor, anxiety conditions or even glaucoma.

Beta-blockers, including beta-blocker eye drops, can interact with other medicines, and in doing so alter the effects of one of the medicines. Some of the more common medicines that can cause interference through interaction with beta-blockers include medicines such as anti-arrhythmics (used to control irregular heartbeats), antihypertensives (medicines for lowering blood pressure), antipsychotics, and clonidine, which is commonly used to treat high blood pressure and migraine.

While the most common side-effects of beta-blockers are dizziness and tiredness, other arising side-effects can include blurred vision, cold hands and feet, and slow heartbeat.

Less common symptoms may include sleep disturbance (insomnia), depression, impotence or libido.

The majority of beta-blockers are to be taken once a day, with the exception of certain beta-blockers that are used during pregnancy and the beta-blocker Sotalol, which is administered two or three times a day. The NHS estimates the annual cost of Sotalol per patient to be 77.09 a year.

On the face of it, the results of the research are pretty straightforward. But are they as almost too straightfoward, to warrant the question of why such research needed to be conducted in the first place?
One cannot blame the cynics for questioning what outcomes the research is meant to arrive at.

Let’s consider the matter in a different light. It is estimated that heart attack survivors have a higher risk of recurrent heart attacks or cardiac death, and 10% of heart attack sufferers die within two years. Only 50% of initial survivors are alive at 10 years.

It is not unreasonable to surmise that those who suffer initial heart attacks either experience mortality between the first and second year or develop recurrent attacks which push them to a compulsory prescription of beta-blockers.

Critics to the research point out that a fairer assessment on the effects of beta-blockers should have examined an extended time period of two years rather than one year. They also point out that the research should have focussed on how many heart attack sufferers, who did not have heart failure, and who then did not use beta-blockers, went on to develop recurrent heart attacks, or heart attacks that included heart failure, as it would be more indicative of the effectiveness of beta blockers.

So why did the findings choose to use the timeframe of a year?

The NHS makes baseline assessments on the cost effectiveness of medicines and treatments according to a scale of quality-adjusted life years, or QALYs. It weighs the cost of treatment against the number of years of significant benefit to the patient gained from the treatment. According to the NHS, a figure of twenty thousand pounds per QALY represents treatment that is value for money. In other words, if a treatment can extend and improve a patient’s life for a year, and costs under 20,000, it is worth it.

The NHS’s Regional Drug and Therapeutic Centre, based in Newcastle, gives the cost of beta blockers as between 10 and 512 pounds annually, depending on the type of beta-blocker required. While this falls well within the QALY threshold of 20,000 pounds, using the research findings that beta blockers have no significant impact on health within the first year allows it to scrap the cost of funding this treatment because beta-blockers supposedly offer no significant benefit. The research has focussed on a time period that cannot significantly examine the effectiveness of beta blockers.

Cynics suggest that the research is merely an attempt to reframe the data regarding beta-blockers in order to minimise the cost of healthcare in an NHS which is lacking in resources.

Medical research, is unfortunately often subservient to economics and often the research appears to be carried out to arrive at a pre-planned conclusion. Wasn’t it long ago, when the economic crisis was looming and the government was looking to raise tax on alcohol, that we were told a glass of red wine a day had health benefits? Yet when the NHS struggled years later and was overburdened by drunken citizens dialling emergency services the evidence peddled about red wine was to the contrary.

The need for cautious antibiotic usage

Antibiotics are medicines which are used to treat forms of bacterial infection or prevent their spread. As the name “antibiotics” suggest, they are anti-bodies and work by killing bacteria or preventing them from reproducing and spreading.

That all sounds impressive. But unfortunately antibodies don’t work for everything. For example, antibiotics don’t work for viral infections such as colds and flu, and most coughs and sore throats. Someone suffering from these infections usually get better without the use of antibiotics. The use of antibiotics to treat these is actually counter-productive, as taking antibiotics when you don’t need them encourages dangerous bacteria that live inside you to become resistant. Over time, this will mean that when you require the help of antibiotics most, they may not work for you as you may have actually been encouraging the tolerance of bacteria by suppressing your body’s ability to fight bacteria.

So don’t use antibiotics for common ailments that can get better on their own. In these situations, what you need is pain relief, and there are many options to choose from. However, antibiotics may be used to treat bacterial infections in cases such as when bacteria could infect others unless treated or infections are not likely to clear up without antibiotics. In other words, if there is further risk of infection to others, or complications which may arise from a lack of treatment, then a course of antibiotics is best followed.

The doses of antibiotics vary but if you are prescribed a course, then take the antibiotics as directed on the packet or the patient information leaflet that comes with the medication. If in doubt then seek advice from the pharmacist.

Antibiotics can be administered in various ways. The most common antibiotics are oral ones, in the form of capsules, tablets or liquid. These are commonly used to treat moderate infections or infections which are milder. There are also topical antibiotics, which are basically creams, lotions, sprays or drops, which are often administered for skin infections.

Topical and oral antibiotics are for less-serious infections. More serious infections, where the medicine has to be absorbed more quickly into the bloodstream, have to be treated by antibiotics administered through injection or drip infusion.

It is essential to finish taking a prescribed course of antibiotics, even if you feel better before the course has ended The prescribed doseage is the estimated time it will take to completely kill off the bacteria. Midway through a course, you may have killed off enough bacteria to not be under the effect of the infection, but stopping the course of antibiotics then can leave the remaining bacteria become resistant to the antibiotic.

But what if you missing a dose of antibiotics? If that is the case, then it is advisable to take that dose as soon as you remember and then continue to take your course of antibiotics as normal. However, if you have missed a dose and only remembered it when it is nearly time for the next dose, it is preferable to simply skip it and merely to continue your regular dosing schedule. Taking two doses only encourages the body to anticipate needing the double doseage in order to fight the infection, and messes up the body’s resistance levels.

Furthermore, there is a higher risk of side effects if you take two doses closer together than recommended. You may experience effects such as pain in your stomach, diarrhoea, and feeling or being sick. Most side effects are gastro-intestinal, and overdosing on anti-biotics may cause bloating, indigestion and diarrhoea.

Some people may have an allergic reaction to antibiotics, especially penicillin and a type called cephalosporins. In very rare cases, this can lead to a serious allergic reaction (anaphylaxis), which is a medical emergency. Sufferers carry an epi-pen and the drug is administered in the bloodstream through injection.

Antibiotics are not over the counter medicines and you should never use any remaining tablets arising from someonbe else’s incomplete course, as you may experience different reactions to the drug. Some antibiotics are also not suitable for people with certain medical conditions, or women who are pregnant or breastfeeding, as they may, for example, adversely affect the lining of the stomach. You should only ever take antibiotics prescribed for you and also never pass them on to someone else.

Antibiotics are only still chemicals and depending on the constituents, some can also react unpredictably with other medications, such as the oral contraceptive pill and alcohol. It’s important to read the information leaflet that comes with your medication carefully and discuss any concerns with your pharmacist or GP.

There are hundreds of different types of antibiotics, but most of them can be broadly classified into six groups. These are outlined below.

Penicillins (such as penicillin and amoxicillin) – widely used to treat a variety of infections, including skin infections, chest infections and urinary tract infections

Cephalosporins (such as cephalexin) – used to treat a wide range of infections, but some are also effective for treating more serious infections, such as septicaemia and meningitis

Aminoglycosides (such as gentamicin and tobramycin) – tend to only be used in hospital to treat very serious illnesses such as septicaemia, as they can cause serious side effects, including hearing loss and kidney damage; they’re usually given by injection, but may be given as drops for some ear or eye infections

Tetracyclines (such as tetracycline and doxycycline)– can be used to treat a wide range of infections, but are commonly used to treat moderate to severe acne and rosacea

Macrolides (such as erythromycin and clarithromycin) – can be particularly useful for treating lung and chest infections, or an alternative for people with a penicillin allergy, or to treat penicillin-resistant strains of bacteria

Fluoroquinolones (such as ciprofloxacin and levofloxacin) – broad-spectrum antibiotics that can be used to treat a wide range of infections

The use of antibiotics especially for conditions that aren’t serious has led to a rise in the number of high-tolerant infections, or superbugs. These superbugs and have a high tolerance to many anti-bodies and include:

methicillin-resistant Staphylococcus aureus (MRSA)
Clostridium difficile (C. diff)
the bacteria that cause multi-drug-resistant tuberculosis (MDR-TB)
carbapenemase-producing Enterobacteriaceae (CPE)

Ridding the world of these types of infections can be challenging, and these superbugs are becoming an increasing cause of disability and death across the world. The biggest worry is that new strains of bacteria may emerge with higher levels of resistance and that can’t be effectively treated by any existing antibiotics, so we have to be wary in how we use them, and when we suffer from minor infections, let the body try to fight off the infection instead of relying on antibiotics which may weaken the body’s immunity in the long run.

Medicines: Brand Names and Generics

William Shakespeare once wrote that “A rose by any other name is still a rose.” And in the pharmaceutical world it is a common occurrence to see that the same medicine can be called by different names. This can prove to be confusing.

Many medicines have two names. The first is the scientific name to the medicine itself – an expert committee decides the generic or common name for it, named for the active ingredient itself. For example, erectile dysfunction is treated by a medicine containing sildenafil, which is a generic name.

The same medicine also has a second name, the brand name. For example, sildenafil is more commonly known by its brand name, Viagra. Pfizer, the company that produces it, has chosen to market it under this name because brand names are more memorable than scientific names, especially at the onset when new products have just been launched. Can you imagine someone going to the pharmacist and asking for the “Silder .. silver … cyber … you know, the thing that gives more bounce and keeps going for longer?”

“Red Bull? Duracell?”

You get the idea.

The company that produces a new medical product is usually granted a patent. This patent grants the company exclusive rights to the product for a standard period usually of twenty years, and allows the company to recoup the investment spent on the development on the drug as well as to financially benefit from sales during the patent period.

While twenty years may seem like an extraordinary amount of time, it is actually not so. Most companies apply for the patent at the initial stages at development, to avoid the situation of being trumped by another company after they have done a few years of research. Imagine you have done five years of research and when you are about to proceed further, someone has applied for a patent for a product that effectively nullifies the work you have done. Or what is worse, they may even draw on your research from various medical publications to further the development of their own product. The time you have spent has been wasted and your intellectual property has been stolen.

The first ten to fifteen years of a patent are hence a covering period for the research into it and to cover the licensing process while the remaining period is the time the company has to solely market the product using as brand name, so that it becomes memorable and commandeers a huge market share after the patent period has expired.

Once the patent protection expires, other companies can produce their own version of the medicine. Hence, pharmaceutical companies are always engaged in a race against time. They have a twenty-year period to research, license, market and profit from their product before the other sharks enter the fray, so to speak.

Take for example, ibuprofen, the medicine commonly used to treat pain and inflammation. There are many branded versions of ibuprofen, such as Nurofen and Hedex. Various supermaket chains distribute their own versions as well, but under the common scientific name. You have Tesco’s ibuprofen or Superdrug’s ibuprofen. We can assume that once a product (such as Neurofen) reaches the mass market, and has been quoted enough times as to “contain ibuprofen”, the scientific name itself becomes somewhat of a brand in its own right.

Having various versions of the same medicine is confusing, but depending on our loyalty we may opt for Neurofen because it is the established brand we know. This of course depends on how it has been marketed; if the pharmaceutical company has done enough advertising to convince us that “Neurofen”, and not “Ibuprofen” is the key to pain-relief, then by association we may go for Neurofen whenever we have a headache. If cost is a more significant factor than loyalty, then we might go for the generic medicines because they are usually cheaper – they have had fewer research and development costs, but they contain the same active ingredient as the branded products.

In some cases latter companies may have simply waited for the patent to lapse, before moving in to reverse-engineer their own version of the product and market it. This is especially true for products that people will always have a need for, such as products offering relief from pain, flu, or colds; or balms of various descriptions.

Generic medicines go through the same detailed safety and quality requirements as the original branded product, but because the significant outlay of research costs have been avoided (the initial company has done the hard work) the latter products are cheaper.

Supermarket chains are already flooded with many versions of the same product. Look at your supermarket chain – how many brands of ibuprofen do they stock? This begs the question of whether chains will eventually simply stick with the products with a big market share (and hence likelihood of sale), stock more cheaper options, or even offer cheaper, newer brands. It is likely that they will do a combination of the first two. New and cheaper brands will find it hard to penetrate the market based on cost alone, as the cost of advertising is too huge. The only way they can hold on to a significant market share is if one of the bigger brands declines, perhaps through negative publicity, and one of the new brands promotes itself by aligning itself with a social cause.

Imagine, for example, there is a medicine called Increasil (scientific name) produced under the brand name Livealongerlife by parent company Healthpharm. Liveralongerlife claims to prolong the life of the terminally-ill and extend their high-functioning years by delaying the onset of infections. After it has been doing well for a few years, towards the end of its patent, it is discovered that Healthpharm conducted unethical drug trials – they tested liquid versions of Increasil by injecting them into corpses to see if it would slow the rate of decay.

Amidst the media storm, the company Fitness21 prepares to produce its own version of Increasil under the brand name Newtrition. They reverse-engineer batches of Increasil, and benefit from the research Healthpharm had previously done. As part of its submission evidence into the safety of Increasil, Fitness21 conducts trials on aging volunteers to see if they experience any increased life expectancy. The evidence gathered by Fitness 21, and also the perceived benefit of Increasil (while it was sold by Healthpharm), contributes to Fitness21 gaining a license to market Increasil in the form of Newtrition.

Fitness21 builds its factories in the impoverished third-world town of Valhalla, promising to regenerate the area. The people of the town benefit from employment, and Fitness21 sells Newtrition to its own employees at a vastly discounted rate, announcing that it hopes to raise the life expectancy of Valhalla from 50 to 75 within two decades, and in doing so, allowing the citizens to have a longer working life and more wealth, with the aim of lifting the town out of its doldrums. Future generations will benefit and the children and grandchildren of those now of working age will have very different futures from their forefathers. Fitness21 announces that its employees are like family, and it has an interest both in elevating their working and life conditions, and the fact that it is distributing Newtrition to its own employees means it has an obligation in ensuring the product itself is of the highest quality. Fitness21 is strongly interwoven and ingrained in the social fabric from which Newtrition is produced.

Whose version of Increasil would you buy? Probably the latter’s. And that is probably the only way for unestablished brands to forge through a packed market, by leveraging on social and ethical links. We have seen various products – not just medicines – marketed using that angle. Do the words Fairtrade and Co-Op sound familiar?

Prescribers (people who prescribe medicines, such as GPs) are encouraged to prescribe medicines by their generic name, not only because it is ethically right to prescribe the medicine costing less if the results are similar – and generic brands can cost significantly less – but also because it gives the pharmacist the widest choice of products to dispense, which can be important, particularly if there is a shortage of a particular product.

If you are switched from a particular brand to a generic, it is standard practice for your pharmacist to explain the changes to you, in terms of side effects, and to address any concerns you may have. In fact, this is not just if you switch brands – whenever you have changes in medication you should always speak to your pharmacist.

Only in rare cases it is important for a patient to stay on the branded medicine previously prescribed for them, rather than changing to a generic medicine. This is usually because of the way the medicine acts on the body.

Some examples of when you should keep taking your brand of prescribed medicine include:

Epilepsy medicines – these should be treated with care because different versions may have slight differences in the way they are absorbed, which can cause big differences in their effect. For example, prescribers may decide the branded version of lamotrigine (Lamictal) is more suitable than the generic version.

Modified-release preparations of medicines – such as modified-release versions of theophylline, nifedipine, diltiazem and verapamil. A branded version may sometimes be a better option than the generic equivalent, as they can be absorbed differently, and suited differently to various individuals.

Biological medicines – these complex medicines are derived from proteins and other substances produced by the body. Copies of biological medicines, called biosimilars, can never be exactly the same so shouldn’t be automatically used as substitutes. Doctors should always reference the brand name so the manufacturer and batch could be identified if there were any problems with the medicine.

Ciclosporin – a medicine that suppresses the immune system (the body’s natural defence system). Different branded versions may cause different levels of ciclosporin in your blood.

Mesalazine – which is used to treat ulcerative colitis (a long-term condition that affects the colon). The way that mesalazine is absorbed varies between different brands.

Lithium – this treats a number of mental health conditions. Different brands vary widely in terms of how much of the medicine is absorbed and becomes active.

Beclometasone dipropionate CFC-free inhalers to treat asthma – there are two inhalers that contain the same active substance (beclometasone dipropionate), but one is much stronger.

Drugs and Side Effects

All drugs come with side effects, whether they be common off-the-counter medicines or ones that require specialist prescription. Most of these effects can be minor, and some can just be an inconvenience – like having to go to the toilet more often than usual. But a few are serious, and some can just have unforeseen effects that address other ailments.

The most common set of side effects for drugs taken internally involves the gastrointestinal system. Because all prescription drugs invariably end up broken down in the stomach, nearly any drug can cause nausea or an upset stomach. The chances of these happening are quite rare, though for the handful of users this happens too the results can be quite upsetting. For drugs used externally, skin irritation is a common complaint. Which leads me to wonder – if you are merely replacing one symptom with another, is medicine merely an elimination of an ill-effect by replacement through increasingly minor symptoms, until they are bearable?

Side effects fall into several categories. The most common allergic reactions can happen with any drug and can range from itching and rash, which cause flaring on the skin and trigger even more itching and rash. They can be serious all the way up to a life-threatening anaphylactic reaction.

So if drugs have side effects, why not just get rid of these effects in the course of construction? Surely the likes of Glaxo Smith Kline, with their huge companies and research budget, can afford to genetically alter the drugs and lower the side effects? Some drugs can’t help but trigger side effects because of their chemical structure. One example is the common allergy drug diphenhydramine (more commonly known by the brand name Benadryl). It eases allergy symptoms but in the course of doing so, it also suppresses the activity of the body chemical acetylcholine. The side effect it causes is drowsiness and a host of other side effects, including dry mouth. It seems like to minimise allergies, it makes you fall asleep. Surely any fool could do that? Want to stop scratching? Go to bed!

Some drugs typically have barely noticeable side effects when dosed properly. The side effects can be minimal externally but internally they can be quite serious. For example, Warfarin (also known as Coumadin or marketed as Jantoven), is used to prevent blood clots, and while it is usually well tolerated, it can cause serious internal bleeding. I suppose it is like cancer, or heavy consumption of alcohol.

And while side effects may exist within the drug itself, further complications may also occur when certain drugs are mixed with certain other things. If you are mixing different types of drugs together, the combined chemical properties might cause complications. I suppose this is why my mother used to say never take Neurofen and Paracetamol within hours of each other. These might also be considered drug interactions. Drinking alcohol with narcotic painkillers has also caused an alarming increase in accidental overdose deaths. What??? Again, part of me wonders whether it isthe interactions of these chemicals that induced these, or whether it was because drinkers thought they had taken drugs to counter the effects like headaches, and then proceeded to consume more than they would normally have. Drinking grapefruit juice can affect the blood levels of several drugs, including some blood pressure and cholesterol medicines. Citrus fruits tend not to mix well with other foods, although vodka and orange seem a common mix?

Information about drugs legally has to be made available on the label of over-the-counter drug products and on package inserts or printed materials included with the packaging. Usually on the outer box you will find the concise version of all the drug does, and the inserts include the longer version. Because this could be potentially be a long list of possible bad effects, and written in a technical style, it is very helpful to also talk to pharmacists or doctors if you have any queries regarding a drug’s side effects..

In America, before a drug is released on the market it must be approved by the FDA. Pharmaceutical companies typically submitted New Drug Applications (NDAs) which contain the pre-requisite clinical evidence demonstrating that the drug has the therapeutic effect it is supposed to have. The NDA must also contain proof that the drug is safe for human use. Unfortunately this proof comes from testing of the drug, first in animals and then in humans. Is it fair that rabbits and rats should suffer for the human race, in cages, doused with experimental acids to see if they develop irritations or severe symptoms? I guess you have to decide for yourself where you stand on that.

Homeopathic remedies may still be a long way away before they can be relied wholly on as a cure, but the day where herbal or plant-based remedies replace animal-treated alternatives is one we can look forward to. Once the basic questions of safety are settled, the FDA will approve the drug if it deems that the benefits outweigh its risks.

Sometimes not everything is known about a drug’s side effects until after it enters the marketplace and more people start using it. The pool of human testers is fairly small, so until a large data sample of users is obtained the side effects are not wholly known. MedWatch, the FDA’s post-marketing surveillance program seeks voluntary input, mainly from health care professionals, on adverse effects they may be seeing in ”the real world”. Sometimes these reports are numerous and serious enough for the FDA to take regulatory action, either through the addition of warnings to a drug’s label. One example of that involves the psoriasis drug Raptiva. The FDA required that the drug carry the agency’s strongest warning, known as a black box warning, after reports of brain infections and meningitis in patients taking the drug were received. The side effects were deemed so dangerous that the drug was later withdrawn from the market. Did the testers not recognise this when the lab mice died?

In soliciting feedback, the FDA also wants input from consumers using the various prescription drugs. All prescription drugs must be labelled with a toll-free number maintained by the agency for the purpose of reporting side effects with drugs. The FDA labels these “adverse events.” Severe side-effects can be reported through calling MedWatch at 1-800-FDA-1088 or through the FDA web site: www.­fda.­gov/­Safety/­MedWatch/­HowToReport/­default.­htm.

As we have seen earlier, the post-marketing information coming in to the FDA is so disturbing that it results in a drug coming off the market. Another case can be seen with the drug Baycol, which lowers cholesterol, after it was strongly linked to a potentially fatal breakdown of muscle tissue. While it had been initially approved in 1997, it was voluntarily withdrawn just four years later when evidence of its side effects was published. The anti-inflammatory drug Duract spent just one year on the market. It had been approved as a product strictly for short-term use, but the FDA found serious liver problems with people taking the drug for longer than what was recommended. Which begs the question: “Who is responsible for regulating patients’ consumption of medicines?” While they are safety guards in place, such as some drugs available only on prescription, what is to stop patients obtaining multiple prescriptions?

That aside, drug companies are also required to report adverse events to the FDA, and failure to do so can lead to prosecution. In 1985, two drug companies were fined and sentenced to community service for not reporting adverse events involving the blood pressure drug Selacryn and arthritis drug Oraflex. Both products were pulled from the market.

In the UK, licenses can only be granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

The stages through which potential medicines are first thoroughly researched start first with the use of tissue culture, followed by computer analysis techniques and finally animal testing.

Likewise, if strict standards of safety and effectiveness are met, clinical trials involving humans can then be used. The license for wider use is approved only if a medicine passes all the phases of clinical trials.

The whole process from discovery to licensing can take a long time, around 10 to 15 years, which means pharmaceutical labs work under a cloak of secrecy and also explains why they may not be willing to withdraw a drug for its side effects if they have invested that much time and money in it.

Not every side effect is a bad one. Some are downright welcome. Take finasteride. Introduced in 1992 to treat noncancerous enlargement of the prostate gland, it was found to regrow hair (and is marketed for that purpose under the name Propecia). Patient: “Doctor, how’s my prostrate?” Doctor: “Under control, but a bit hairy.”

Today, millions of men use a low dose of finasteride to treat male pattern baldness. Minoxidil, originally marketed as an oral tablet for high blood pressure, was found to grow hair in those using it. Today, as a topical lotion or foam, it is a popular over-the-counter remedy for baldness. But can you imagine the doctor going “Your blood pressure is normal, Chewbacca”?