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.

Is it possible too that there might be a non-medical cure for the disease? The BBC reported that more and more elderly people are taking up piano lessons to combat the onset of Parkinsons (http://www.bbc.co.uk/programmes/p04p50gg). Bearing that most cases of Parkinson’s are not hereditary, and that developing the skill of piano playing is not hereditary either, and depends on the effort of the individual himself, is it possible to build up a non-medical prevention for Parkinson’s? Only time will tell.

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.