New breakthrough in heart attack treatment

Are we edging closer towards lowering the risk of recurring heart attacks? Scientists definitely think so. In what has been described as the biggest advance since the discovery of statins, a study has shown that anti-inflammatory injections could lower the incidence of recurring heart attacks in heart attack survivors. Furthermore, these injections have been suggested to also slow the progression of cancer.

It has been discovered that heart attack survivors who were administered injections of a targeted anti-inflammatory drug called canakinumab had a lower risk of such attacks in the future. With this particular drug as well, the incidence of cancer deaths were also reduced to less that fifty percent.

Canakinumab is not normally prescribed for this purpose; its function normally lies in the use for rare inflammatory condition. Instead, the current drugs for the prevention of heart attacks are statins. The main method in which statins prevent heart attacks from recurring is by lowering cholesterol levels. Despite this, statin users who regularly take the drug have a one in four chance of suffering another heart attack within half a decade. While the cause for this is unknown, and research has been done on heart attacks and statins, the current line of thinking is that inflammation within the heart’s arteries are the cause of this recurrence.

The research team followed over 10,000 patients and were led from Brigham and Women’s hospital in Boston. One of the hypotheses tested was whether targeting the inflammation with a potent anti-inflammatory agent would provide an extra benefit over statin treatment. In other words, the trial aimed to see if statins combined with canakinumab would be better than just statins alone. The 10,000 patients who had had a heart attack and had all received a positive blood test for inflammation into the trial. In addition to the doses of statins, patients also received either canakinumab or a placebo, both administered by injection every three months. The trial, also known as the Cantos study, lasted for four years.

For the first group – patients who had received the canakinumab injections – the results demonstrated that there had been a 15% reduction in the risk of a cardiovascular event; this means that the risks of heart attacks, either fatal or non-fatal, and strokes had been reduced. But the benefits of canakinumab did not merely end there. The need for expensive interventional procedures, such as surgery such as bypass surgery, or the insertion of stents, was reduced by over three-tenths. The drug did not, however, change cholesterol levels, meaning that it must still be used alongside statins, and the use of statins as cholesterol limiters will still continue to remain so. There was also no significant statistical difference in the number of death rates between patients who had received canakinumab and those who had been given placebo injections.

Dr Paul Ridker, who led the research team, said the study did “usher in a new era of therapeutics”.
This study is the first incidence where scientists have been able to show conclusively that the risk of cardiovascular risk is reduced when inflammation independent of cholesterol is lowered. Why the results have been considered ground-breaking is due to the insight that they have provided; there could be an entirely new way to treat patients and significantly improve health outcomes through the targeting of inflammation, jointly with the lowering of cholesterol. The statistical benefits for patients who took canakinumab were described as being “above and beyond” those seen in patients who only took statins.

Dr Ridker also mentioned that the study showed that the use of anti-inflammatories was the next big breakthrough following the linkage of lifestyle issues and then statins.

“In my lifetime, I’ve gotten to see three broad eras of preventative cardiology,” he said. “In the first, we recognised the importance of diet, exercise and smoking cessation. In the second, we saw the tremendous value of lipid-lowering drugs such as statins. Now, we’re cracking the door open on the third era. This is very exciting.”

But despite the promising results of the treatment, it was not without its negatives. The researchers reported that there was a rise in the potential chance of dying from a severe infection for about a tenth of a percentage point, although this increase was counterbalanced by decrease by over 50% of cancer deaths across all cancer types. The most promising cancer reduction rates were seen in the case of lung cancer. The odds of dying from lung cancer, with the use of canakinumab, were reduced by over three quarters. There was no scope within this study to investigate that further, although subsequent trials to investigate canakinumab’s effect against cancer are being considered.

Prof Martin Bennett, a cardiologist from Cambridge, had no involvement in the study, and while he said the trial results were a promising insight in understanding the occurrence of heart attacks, he expressed concerns both about the side effects, whether the high cost of the drug would pass the Quality Adjusted Life Years (QALY) test that the NHS administers to determining cost effectiveness of drugs, and also the fact that there were no significantly lesser incidences of deaths between those prescribed canakinumab and those who had received the placebo.

“Treatment of UK patients is unlikely to change very much as a result of this trial, but the results do support investigation of other drugs that inhibit inflammation for cardiovascular disease, and the use of this drug in cancer,” he said. In other words, despite the results of the study and what we can glean from them, he believes statins will still remain the mainstay of recurrent heart attack prevention.

Prof Jeremy Pearson, who is the associate medical director at the British Heart Foundation, showed more positive belief about the trial and the possibilities of it opening the doors to new types of treatment for heart attacks.

He mentioned that heart attacks account for a high number of hospitalisations every year. The figure is thought to be close to two hundred thousand people each year in the United Kingdom. He further explained that the use of cholesterol-lowering drugs like statins, when prescribed to these people to reduce their risk of another heart attack, does save lives, but the reduction of high cholesterol rates as a mere medical focus alone is not always a measure that effectively deals with the whole of the problem.

He added that one could be forgiven in feeling a flutter of excitement when it came to these trial results, which have been eagerly awaited by the medical community. The confirmation of previous medical hunches that the continual inflammation is a significant contributor to the risk of heart disease, and that the intent to reduce it could help save lives, is a significant way forward towards the treatment of heart attack patients.

 

This research into canakinumab is one of many that have been conducted into heart attack prevention. We should be cautious about its possible side effects; aspirin, for example, has been shown to cause bleeding when prescribed to heart attack patients. It has also been suggested that  beta blockers for heart attack patients, on the other hand, do not have the ascribed health benefit. Furthermore, if the drug does end up prescribed to heart attack sufferers, what are the side effects when taken for the long term?

Could we possibly see canakinumab being prescribed as a matter of course for heart attack patients to prevent a recurrent? The answer perhaps lies not with whether or not the drug has benefit – it has already proven this in some areas – but whether the side effects can be mitigated. More importantly, the issue of cost will probably determine its future. If the cost of canakinumab could be lowered, so that its prescription to the over two hundred thousand heart attack sufferers per year would not be a significant burden on the financial limitations on the health service, then we could see it being prescribed as a matter of course. If not, then we may have to wait for a less expensive substitute to hit the market. And while it is somewhat disheartening that medical intervention in recent times is more geared not towards finding medicine that works, but medicine that is cost effective, the promise of canakinumab nevertheless is a positive health step.

Sustainable healthcare is not as clear-cut as it seems

Sustainable healthcare is thought of as the provision of future approaches to health, care and wellbeing in an increasingly environmentally and financially sustainable manner, and one which also makes intelligent use of our abundant social and human resources.

Proponents of the sustainable healthcare approach point out that in our current place in time, and for the future – our future, the future of the generations after us, and the for earth’s future itself – we need to ensure that the healthcare institutions need to make minimal impact on the environment, so that there is an environment for future generations, and not one that has been plundered of its resources.

The thinking behind the sustainable healthcare approach is that in operating with a minimal-impact focus, there is an added benefit in doing so, because operating costs can supposedly be minimised as well. There is a perceived amount of overlap in these two areas, and avoiding unnecessary environmental harm while reducing waste can also save money. One quoted instance of this is how the use of ultra-low energy lighting in hospitals requires less power demands, which means an efficient distribution of electricity at the power plants, and ultimately this all can be traced all the way back to making less environmental impact whilst saving on electrical costs.

But how much of this interest in sustainability is genuine, and how much of this is merely a governmental facade to mask or sidestep the issue of reduced health budgets?

Yes, ultra-low energy lighting can minimise running and environmental costs, but is the manufacturing process of the lighting itself sustainable? And will the ultra-low energy lighting pay for itself over its lifespan?

Let’s consider this example. Suppose it costs £20,000 to replace the outdated lighting systems in a hospital with the new flash lighting. Throw in an added £5,000 for labour costs. Assume the new lighting lasts 20 years before it needs to be replaced. Will the £25,000 costs be significantly made up over the twenty years to warrant its installation in the first place?

Whether or not it is possible to do so, it is arguable that even if it isn’t, it is more PR-friendly for organisations to be viewed in the public eye as sustainable, and they will rush to choose measures which may be seen to be sustainable, rather than carefully evaluate their options. This only opens things up to abuse as suppliers will merely jump on the bandwagon and market products under the guise of being sustainable.

Take for example, the case with Salford City Council. Years ago, when the trend for recycling was at its peak, the council unceremoniously dumped five wheelie bins in every household without consultation. The move was supposedly to encourage recycling. But what resulted was a stealthy method to cut the frequency of bin collections from once every week to fortnightly, as well as cut the number of waste collection workers by forcing residents to sort out the recycling. But where did the money for four extra bins per household come from, apart from through higher council tax charges, and did the extra financial cost, as well as the added time of a rubbish truck emptying five bins instead of one, thereby causing road congestion, save costs in the long run? Probably not. In the rush to be seen as being eco-friendly, it is ironic that it cost more to be viewed as so, rather than to not be eco-friendly at all. The extra cost went into buying a perception. We must not make the same mistake with sustainability.

Proponents of sustainability in healthcare suggest that health is also won or lost outside formal health and social care settings. The hospitals and other care organisations do not govern the lives of individuals. Individuals themselves can empower themselves to live better lives, by making better choices so as to require less medical care and ultimately make less demands on the healthcare system and the environment. Sustainable healthcare, they say, means a thorough examination of how we are living – how we eat better, how we move our own bodies more, how we develop new ways of protecting and improving health. It is about empowering the individual to lead a pro-active lifestyle.

Another idea put forth is that the quality of resilience needs to be imbibed in people, families and communities, especially when you consider the increasingly frequent extreme weather. Is this a subtle way of saying “in times of harsh weather conditions – like extreme cold or heat, instead of getting in touch with your GP, just tough it out?”

It is suggested that what is needed is a collective effort in supporting and growing effective networks within communities so that the health system works to provide support and services alongside people rather than just to people. How does this help the system to be sustainable? The claim is that pre-existing logistical setups are already in place and aid can be delivered swiftly to recipients – the cost of setting up a delivery system is negated by using one that is already in existence.

The proposed sustainable health strategy is based on three principles, and launched jointly by leaders from the NHS, the social care system, local government, and Public Health England.

Firstly, a healthy society depends on a healthy environment: clean air to breath, green spaces for children to play in, safe places to walk and cycle, and a radical reduction in our greenhouse gas emissions.

Secondly, the health and care system is increasingly aware of the benefit of helping to develop resilient communities: resilience that is fundamental to health and wellbeing, both in times of relative stability, and in times of crisis.

Thirdly, the health and care system can take every opportunity to work with people to prevent the preventable and manage the manageable. This means helping us all improve our understanding and control over our own health, illnesses and opportunities and to take pro-active steps over our health, within our homes and communities. The traditional model that exists at this time is of citizens being well, then falling ill, before being treated and getting better is increasingly outdated. This, in essence, is passing on the responsibility for our own health to the state. We need to make increasingly wiser choices over our health and manage ourselves with the support and guidance of the health and care system using improved information, integration, collaboration and technology.

However, this third principle requires a cultural shift for public, patients and particularly professionals. We have business models that are built on the foundations of people getting ill. We pay insurance premiums, private medical treatments, and existing business models rely on poor health to function rather than improved health. What would happen to hospitals and staff if people lived better? We would have a surplus and would have to close them down. Cynics could be forgiven in thinking that sustainability is the guise under which the NHS meets budgets through cuts. The existing models we have depend on certain numbers of people being ill in order to function. But in the light of diminished financial resources, this rethink may come sooner and seen more positively. We may need more diverse business models for providers of care. We could reward care providers for the amount they reduce death rates or health inequalities or survival times or for simply improving the experiences of patients. But will this only complicate matters by only shifting traditional costs elsewhere?

Those who hold responsibility in commissioning healthcare are increasingly choosing to focus on outcomes as the marker for remuneration. There are many examples already in existence in our society already, where care is less focussed on a hospital setting and more in the community. This can be through more programmes which are community based ones. Or it is suggested we could rely on interventions in partnership with the voluntary sector, or – through the use of technological opportunities – even care in the home. And the societal focus of rewarding providers of care for outcomes rather than just activity might uncover methods that are more creative, cost effective, and appropriate ways of keeping people informed, independent, and healthy. It is a way of allocating resources to encourage positive needs. Cynics may suggest that this is a subtle way of shifting government responsibilities lower down to the community, in light of budget cuts, but it remains to be seen whether individuals in need get help more sooner within their community, and the redistribution of care resources down the chain to the community, which is already in place, rather than wait for government initiatives to filter through after legislation and debate, means that a community-based system is more responsive and more agile.

Devolving responsibility and dividing care provision requires overall coordination to ensure facets run smoothly. If what was amalgated under a traditional NHS is now devolved to various third parties, who will be in charge of overall co-ordination? Will the cost of overall co-ordination actually prove to be more expensive in the process? In the latter case, probably not – but why? Because the responsibility for co-ordination will probably fall to a computer system, and any failings of this system will be explained away by traditional excuses we ascribe to technology; and without having a person to blame anyway, we will have to grin and bear it. Be resilient.

This move towards reaching a sustainable health service is partly technological, but other factors such as the economic, social and cultural also come into play. It will only be achievable through various shared values – honesty, partnership, social involvement. Business models and technology widely used outside in other facets of society have to be used creatively in order to deliver a safer, fairer future. One of the challenges is that sustainability and commerce do not easily mix, and the transition must be carefully managed. Sustainable models are efficient and usually low-cost, and as a form of revenue and unemployment do not offer as much as commerce-based models. And as organisations such as the health service move towards a lean, agile and efficient mode of service, unfortunately it is a likelihood that such sustainable models mean that individuals employed in traditional sectors may require re-training to find continual employment.

This strategy for the future has been shaped and supported by partners across the system, not just by a single organisation. This is vital because, although we know much about what needs to be done, we really are not yet certain how to do it together, ensuring our collective efforts add more value than the sum of our individual approaches. Society as a whole needs to move forward together, inching our way collectively so that we can all adapt to the various stages of the transition. Binding all of these approaches into a sustainable approach focusses us on the truth that a liveable community for our children is more important than a growing economy.

The health and care system should not entertain the thought that it is separate from the challenges (and opportunities) that are presented by a rapidly changing world. A future-focused health and care system is the most obvious representation of a collective effort for the common good. But the scale and pace of this move is needs to be realistic and functional, and it extends beyond specific health areas alone. Moving towards a sustainable health model is not just about making the NHS more efficient and environmentally-friendly. It is about creating a sustainable world for future generations through its constituents, and fostering shared capabilities so not only is the sense of community and a shared world an attainable vision, but working demands are shared to minimise wastage and tax on the environment. The NHS is one such constituent to institute this change in thinking and move it forward.

Healthcare is a fine example of a sector to set clear examples of our collective responsibility to the future. In the current financial climate of constraint there is opportunity for this evolution of healthcare to go forward. What is being proposed is good for the purse, good for our families, and good for the future. Ultimately this reduces the cost of state healthcare, empowers individuals to take charge of their own, and whatever resources are available are delivered to those who need it in an efficient way.

What does all this mean for the NHS? Among other things, it means the health service must:

1) Operate sustainably, minimising its impact of the environment. This means the physical infrastructure of the NHS has to be sourced from means that are as environmentally-friendly as possible.

2) Continue to source its needs from sustainably-beneficial agencies. An example of this is that if the NHS has two pharmaceutical companies offering the same drug at similar prices, it engages the one with more environmentally-friendly policies. This is to promote the use of sustainable measures to its partners.

3) Impart knowledge through the use of community-based programmes to encourage personal responsibility for health. The NHS can support local programmes, for example by setting up stalls in school fairs to promote health advice or encourage people to do health testing, among other things, so that tests that are routinely conducted at hospitals or GPs are done elsewhere, resulting in time savings, and also encouraging individuals to maintain responsibly from their health by having constant local reminders within the community framework.

4) Conduct constant research in order to find better medicines – “better” not necessarily in the sense that the cost is lower, but better in the sense that they can be constructed from more natural sources, and hence require less demands on the environment during production. In this, the NHS may have to turn to various alternative therapies such as homeopathy, Chinese medicine, or preventative therapies such as the Alexander Technique.

5) The NHS also has to collaborate with partner agencies that can provide long-term non-medication solutions. For example, research on mental health has suggested that while medication for serious health issues has benefit, milder forms of mental health are equally well-addressed with cognitive therapy rather than medication, and cognitive therapy also has more lasting impact and a lower chance of relapse than medication. In the long run it is not conceivable that a sustainable health service would cultivate a society that is less dependent on medication as a quick-fix remedy, but one that encourages its citizens to closely reflect on how they are living their lives in order to live free of medication as far as possible.

The challenge in implementing all this, as we have previously mentioned, is that as organisations and processes become more streamlined, cost-effective and environmentally-friendly, economies which depend on growth – essentially, ALL of them – and government which raise finance from taxation – again, ALL of them – start to suffer. Sustainable organisations employ less people. And the more sustainable an organisation becomes, the less people it employs. Even the large organisations that focus on saving the environment have a majority of their workforce consisting of volunteers. This means a huge chunk of the government budget attained from working tax is lost, and a equally worrying time-bomb is large numbers of unemployed with no financial means of securing a living property.

Taxes on working profits will fall, because the silent partner is sustainable schemes is low cost. Would you pay more for the same product or service, if the product carries a promise to invest sustainably? Would you pay more for Fairtrade products? Most, apart from those with more disposable income, would probably go cheaper, given that society will have to live with financial constraints for years to come. The tax on a lower-cost product is less than that on a higher-cost product, which means the government has less revenue.

We arrive at a situation where the government has less funds to distribute, organisations that have less funding but have to find ever more ingenious ways to use or grow that forever-dwindling income. At the same time we have a situation where the numbers of jobless will continue to grow, many will remain on low-wage jobs, while property continues to spiral out of reach. It is not an economically-sustaining situation. It begs the question – are we only pushing the demands on the environment that we made, while we were focussed on growth, back to the economy again?

A sustainable health service, and living sustainably, is essentially a dismantling of the economy that we have come to build.

The future is uncertain. It is scary and will require careful negotiation. We’re sure we need to live sustainably and make less demands on the environment, but we haven’t quite worked out fully how to transition there, nor what we will do when we really get there.

Are we nearing a medical cure for Parkinson’s disease?

Are we edging towards a cure for Parkinson’s disease? A study in the medical journal Lancet suggests that while we may still be a bit away from a total cure from the disease, there is enough evidence to suggest that it may soon be possible to halt its progression, which is the next step towards managing or eliminating a disease that causes damage to the brain, tremors, difficulty with movements and eventually memory problems.

Parkinson’s disease is caused by the loss of cells which produce the chemical dopamine. The decline to the brain is slow but eventually the accumulated damage causes mental and physical problems. There is no cure for it but current therapies can help to contain the damage and manage the symptoms. They work by boosting dopamine levels, but only manage the symptoms without addressing the damage to the brain.

The Lancet reports that there is evidence now to suggest the progression of Parkinson’s can be delayed. The damage to the brain can be restricted so that no further damage is done. This means that Parkinson’s sufferers retain their mental capacities at the point of diagnosis. This is promising news and the answer lies with a drug normally used in type 2 diabetes.

The trial in the research published in the Lancet was only conducted on 62 patients, so while the evidence is promising and optimistic, further evaluation and studies need to be carried out in order to confirm the findings and the news should be received cautiously. The long-term benefits or side effects are also not completely certain yet. The drug will need more testing; it is easy to be carried away with initial findings but all medication has side effects, either on mental states or physical well-being that we should be mindful of.

The study was conducted by a team from University College London (UCL) team. “There’s absolutely no doubt the most important unmet need in Parkinson’s is a drug to slow down disease progression, it’s unarguable,” Prof Tom Foltynie, one of the researchers, told the BBC.

Currently, there is no drug which achieves that effect. The drugs that are currently prescribed only manage the symptoms, but do not address damage to the brain.

The study divided the 62 patients into two groups. One group received the drug exenatide, which is normally used in the treatment of type 2 diabetes. Another group was given a placebo. Patients were unaware of which treatment they were receiving. For precautionary reasons, all patients also continued to remain on their usual medication.

The 31 patients who received only their usual medication showed symptoms of decline usually associated with Parkinson’s disease. This decline manifested itself both in mental states such as forgetfulness and memory loss, or through the loss of locomotor movement. The results were apparent over a period of 48 weeks.

Patients for whom exenatide was prescribed displayed stability in their results. In other words, their decline due to Parkinson’s was halted. Not only was the further damage to the brain restricted, the loss of physical movement was contained. This suggested that exenatide could have some role in the damage limitation of Parkinson’s disease.

The initial study took place over a year and after that those on exenatide came off the treatment. Yet the benefits of taking the drug continued for up to three months.

 

Prof Foltynie said, “It gives us confidence exenatide is not just masking symptoms, it’s doing something to the underlying disease.”

Nevertheless, he urged, while we have reason to be encouraged by these positive findings, they still need to be replicated on a larger scale, and the drug also needs to be trialled for a much longer period before any suitable effect and link can be stated.

Another reason to be cautious is that the drug exenatide only made a difference over a maximum trial period of sixty weeks. But in real life Parkinson’s disease afflicts individuals over a prolonged period. The introduction of any new drug into the human body usually causes a noticeable effect at the onset anyway, as the body is flooded by chemicals, but the effect needs to be maintained for prolonged periods without losing consistency. In this particular, case, for a drug to be effective against Parkinson’s disease, it will need to hold back the damage to the brain for years in order that patients who are prescribed the drug would experience a significant improvement on the quality of life.

The effect of Parkinson’s disease is slo. Sufferers experience damage to the brain and slow decline on mind and body over years, sometimes extending up to a decade. The team from University College London said that their research in this 60-week trial produced statistical improvements in quality of life scores, but they will need to extend the benefit over a longer period.

Exenatide’s traditional role as part of a diabetes treatment is in controlling the blood sugar levels in the body. It does this through the action on a hormone sensor known as GLP-1. It is believed that Exenatide makes the hormone sensors work more efficiently or perhaps it improves their ability to survive.

But the GLP-1 sensors are not just found in the body. They are also in existence in brain cells. Those sensors are also present in brain cells too. The current thinking behind using Exenatide in some form as a Parkinson’s disease treatment is that if it can make hormone sensors in the body more efficient, so that they manage blood sugar levels better, then they may have a significant role if used to improve the sensors in brain cells.

It is specifically for this reason that the research of the drug is also being widened beyond its effect on Parkinson’s disease, but also in other neurodegenerative diseases such as Alzheimer’s disease.

David Dexter, the deputy director of research at Parkinson’s UK indicated that there was hope offered through the finding that drugs like exenatide, or perhaps similar ones, could slow the course of Parkinson’s that we currently take for granted. They offer some posibilities that other drugs do not.

“Because Parkinson’s can progress quite gradually, this study was probably too small and short to tell us whether exenatide can halt the progression of the condition, but it’s certainly encouraging and warrants further investigation.”

But amidst all the optimism generated by the possible positive effects on exenatide, Dr Brian Fiske, from the The Michael J Fox Foundation for Parkinson’s Research, cautioned that “the exenatide studies justify continued testing” but that clinicians and patients should not rush to “add exenatide to their regimens” until the impact and safety of exenatide had been proven.

How does Parkinson’s disease gradually lead to the decline of physical movements and memory loss? The disease affects the brain by a slow process of decline and brings on debilitating loss of movement. It has since been discovered that the damage to the brain is also synonymous with accumulation of high levels of the protein alpha-synuclein in the brain.

Scientists at Columbia University Medical Center and the La Jolla Institute for Allergy and Immunology found that T-cells, a part of your immune system, tries to destroy the alpha-synuclein in Parkinson’s disease sufferers, but it is through the killing of alpha-synuclein as an auto-immunity measure that the T-cells inadvertently kills brain cells where the alpha-synuclein accumulates. In other words, a malfunctioning immune system is destroying brain cells, which then have a knock-on impact on the brain’s health and physical functions.

In recent years scientists have made significant progress in their understanding of Parkinson’s disease. One emerging possibility that is gradually gaining ground in that Parkinson’s may have its origins in the gut.

“We imagine that T-cells may first identify alpha-synuclein out in periphery, particularly in the nervous system of gut which is not a problem until the T-cells enter the brain.”

Dr Alessandro Sette, from La Jolla, said: “Our findings raise the possibility that an immunotherapy approach could be used to increase the immune system’s tolerance for alpha-synuclein, which could help to ameliorate or prevent worsening symptoms in Parkinson’s disease patients.”

David Dexter also said that the research lent weight to the idea that “the condition may involve the immune system becoming confused and damaging our own cells.

He stressed however that more needed to be done in order for us to have some understanding about how, in the complicated chain of events that lead or contribute to Parkinson’s, the immune system – or a faulty immune one – played its part in the overall grand scheme of things.

Nevertheless, he added that the new research presented new avenues and opened up new insights into current Parkinson’s treatments. He was optimistic, perhaps cautiously so, that “this presents an exciting new avenue to explore to help develop new treatments that may be able to slow or stop the condition in its tracks.”

Is a medical cure for Parkinson’s disease on the horizon then? Perhaps in fifteen or twenty years’ time, we will look back upon these discoveries – that exenatide halts the decline of the brain by improving the proficiency of GLP-1 hormone sensors in the brain; that Parkinson’s disease originates in the gut; that managing the tolerance for alpha-synuclein by T-cells in the brain prevents them from destroying brain cells which lead to impaired mental and physical function – perhaps in the future we will look upon them as defining moments in the cure of Parkinson’s disease.

So could we expect medical prescriptions for Parkinson’s disease soon? At the earliest, a medical prescription for Parkinson’s will take at least ten to fifteen years to be made available. Pharmaceutical companies are normally granted a patent of twenty years to be the sole distributor of a medical product, in order to reward the impetus and the research undertaken into the product. At least half the amount of time is spent on research and further clinical trials. Most pharmaceutical companies apply for their patent from the time detailed research begins, so that the event that having done a significant part of their research, another company is awarded the patent, is avoided. So the moment a patent is awarded, in this case, for exenatide or a derivative product to tackle Parkinson’s disease – that is a sign we could expect a cure in about ten to fifteen years.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What antibiotics in agriculture are really about

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Therein lies the problem.

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

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

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

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

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

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

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

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

The problem with industry-funded drug trials

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Where Will factors in mental health treatment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Why clinical trials exist, and how to sign up

A clinical trial is a research method that compares the effects of one treatment with another. The subjects of a clinical trial can be patients, healthy people, or both.

If you are interested to take part in a clinical trial, you can ask your doctor or a patient organisation if they know of any clinical trials that you may be eligible to join. Other ways of finding out including registering your interest in taking part in research online.

The UK Clinical Trials Gateway (UKCTG) website searches through different registers and pulls through information about clinical trials and other research from several different UK registers. When you sign up to it, researchers will get in touch about research that might be suitable for you.

While this is the main method of contact, you can also search the UKCTG site to find trials relevant to you, and you can contact researchers yourself.

If you are looking for something on a global basis, the World Health Organization’s Clinical Trials Search Portal provides access to clinical trials in countries all around the world.

Charities can also be a good source of clinical trials.

Some charities which look for people to take part in clinical trials include:

  • Arthritis Research UK: current clinical trials and studies
  • Cancer Research UK: find a clinical trial
  • Multiple Sclerosis Society: MS clinical trials
  • Target Ovarian Cancer: clinical trials information centre
  • Parkinson’s UK: clinical research

Why would anyone consider being a human guinea pig? If we are brutally honest, that is what it amounts to. And if we were being very honest, we might fine-tune it down to two reasons: treatment and financial incentives.

Clinical trials help doctors to understand about how they can treat a particular disease or condition. It may benefit you, or others like you, in the future. And if you participate in a clinical trial, you may be one of the first people to benefit from a new treatment. However, you must be prepared that the new treatment may turn out to be no better, or worse, than the standard treatment, and that your participation is the method through which they find out. However, you may be placed in the control group, which means you not receive any treatment, but others who do have their results compared to you – and that can be very disappointing.

Some clinical trials offer payment, which can vary from hundreds to thousands of pounds depending on what is involved and expected from you. The majority of trials however are unlikely to offer payment beyond your travel expenses.

Before you sign up to a trial, it is important to find out about the inconvenience and risks involved and to carefully weigh up whether it is worth it. You have to remember that trials can be time consuming – you may be expected to attend a number of screening and follow-up sessions, and some trials require you to stay overnight. In addition to the constraints placed on your time, there may be restrictions on what you can and cannot do – for example, you may be asked to not eat or drink alcohol for a period of time. As trials are essentially the assessment of treatment in their experimental stages, you may experience unknown side effects from the treatment.

All clinical trials of new medicines go through three or four phases to test whether they are safe and whether they work. The medicines will usually be tested against another treatment called a control and the results compared to note any significant effect. The control will either be a dummy treatment (a placebo) or a standard treatment already in use.

The first phase of the trials involves a small number of people, who may be healthy volunteers, are they are given the medicine. In this phase, the drug is being trialled in human volunteers for the first time and the purpose is for the researchers to test for side effects and calculate what the right dose might be to use in treatment. Unfortunately if the doseage is too high side effects can be uncomfortable. Researchers start with small doses and only increase the dose if the volunteers don’t experience any side effects, or if they only experience minor side effects. Sometimes the threshold to which side effects occur is sought – not nice!

In the second phase, the new medicine is tested on a larger group of people who are ill. After having passed the side effects filter, this stage is to get a better idea of its effects in the short term.

The third phase involves medicines that have passed phases one and two. These medicines are tested in larger groups of people who are ill, and then they are compared against an existing treatment or a placebo to compare the benefits or side effects. Often after this stage the treatment is examined for its cost-effectiveness as well.

Some medicines undergo a fourth trial phase while they have been passed for use. The safety, side effects and effectiveness of the medicine continue to be studied while it is being used in practice. However, this is not required for every medicine. It is only carried out on medicines that have passed all the previous stages and have been given marketing licences – a licence means the medicine can be made available on prescription. You can find out about the whole process here in greater detail.

You cannot choose which group you are put in when you are accepted for a clinical trial. You will usually be randomly assigned to either the treatment group – where you’ll be given the treatment being assessed, or the control group – where you’ll be given an existing standard treatment, or a placebo if no proven standard treatment exists.

And while the treatments are different in the two groups, researchers try to keep as many of the other conditions the same as possible, so that the effect of the treatment can be fully quantified. The conditions may extend to the trial groups. For example, both groups should have people of a similar age, with a similar proportion of men and women, who are in similar overall health. In most trials, a computer will be used to randomly decide which group each patient will be allocated to, in order to avoid human bias in selection. In many trials, nobody knows who’s been allocated to receive which treatment. This is known as blinding, and it helps reduce the effects of bias when comparing the outcomes of the treatments.

If you do express interest in a trial, a doctor or nurse is likely to tell you something about it in person before you undergo it. You’ll also be given some printed literature to take away, and if you have concerns over the trial you may come back with some questions you feel haven’t been answered.

Some questions you may ask may include:

What is the aim of the trial and how will it help people?
Who is funding the trial?
What treatment will I get if I do not take part in the trial?
How long is the trial expected to last, and how long will I have to take part?
How long will it be before the results of the trial are known?
What will happen if I stop the trial treatment or leave the trial before it ends?
What would happen if something went wrong? It’s rare for patients to be harmed by trial treatments, but you may want to ask about compensation if this were to happen.
Practical questions
How much of my time will be needed?
Will I need to take time off work?
Will I be paid?
Will the costs of my travel to take part in the trial be covered?
If the trial is testing a new drug, will I have to collect it from the hospital, will it be sent to me by post, or will I get it through my doctor?
Will I have to complete questionnaires or keep a diary?
What are the possible side effects of my treatment?
How could the treatments affect me physically and emotionally?
Who can I contact if I have a problem?
Will someone be available 24 hours a day?
How do I find out the results of the trial?

There are many questions you may have and it is best to feel fully secure before you undergo a trial. As in the case with any treatment, you can’t be sure of the outcome. And if you are part of the treatment group, you may be given a new treatment that turns out not to be as effective as the standard treatment. As with all medicines, it’s possible you’ll experience unexpected side effects. And while it is rare, you must be prepared that you may leave the trial in a slightly poorer state of health than when you entered it! You may decide to stop taking part in a trial if your condition is getting worse or if you feel the treatment isn’t helping you. Your departure can be at any point without giving a reason and without it affecting the care you receive.

A good thing to also bear in mind about trials, too, is that you may have to visit your place of treatment more often, or have more tests, treatments or monitoring, than you would if you were receiving the standard treatment in usual care.

At the end of the trial, the results are published by the researchers and are then made available to anyone who took part and wanted to know the results. If the researchers neglect to offer you the results and you want to know, you are well within your right to ask for them. Bigger agencies such as the National Institute for Health Research (NIHR), have websites where they publish the results of the research they have supported.

Trials are regulated and judged ethical by the MHRA. Before a clinical trial of a new medicine can begin, a government agency called the Medicines and Healthcare products Regulatory Agency (MHRA) needs to review and authorise it. One of the functions the MHRA performs is in inspecting sites where trials take place to make sure they’re conducted in line with good clinical practice.

Another body, the Health Research Authority (HRA) works to protect and promote the interests of patients and the public in health research. It is responsible for research ethics committees up and down the country.

All medical research involving people in the UK, whether in the NHS or the private sector, first has to be approved by an independent research ethics committee. The committee protects the rights and interests of the people who will be in the trial.

What are the benefit of clinical trials? Well, they can benefit us in many ways. For example, clinical trials can:

  • prevent illnesses by testing a vaccine
  • detect or diagnose illnesses by testing a scan or blood test
  • treat illnesses by testing new or existing medicines
  • find out how best to provide psychological support
  • find out how people can control their symptoms or improve their quality of life – for example, by testing how a particular diet affects a condition

Many clinical trials are designed to show whether new medicines work as expected. These results are sent to the MHRA, which decides whether to allow the company making the medicine to market it for a particular use. The company usually applies for a twenty year patent to cover the research and marketing of the drug exclusively.

If research has identified a new medicine, the MHRA must license it before it can be marketed. Licensing shows a treatment has met certain standards of safety and effectiveness. The safety of the medicine must be monitored carefully over the first few years of a newly licensed treatment. This is because rare side effects that weren’t obvious in clinical trials may show up for the first time.

You may not have been selected for a trial but you may express interest in the results. You can find various results of clinical trials from sources such as:

  • The Lancet medical journal
  • British Medical Journal (BMJ)
  • The New England Journal of Medicine
  • Cochrane Library – a collection of high-quality evidence
  • NHS Evidence database

Many of these publications offer abstracts, which are shorter summaries of the research. If you wish to delve deeper,
you usually have to take up a subscription to the journal. But before you do so, consider that research papers are not written in plain English and often use many medical, scientific and statistical terms which then make them possibly very difficult to understand.

The mainstream media offer a more readable version of the research. But do bear in mind, too, that while news stories are easier to read than original research papers, sometimes the findings are exaggerated or sensationalised in order to sell papers!