Pf Magazine: August issue out now! Read it here.

by Hazel Lodge 14. August 2016 08:22

 

 

 

 

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Features

Dangerous liaisons: GPs are failing transgender patients

by Admin 8. August 2016 09:41

 

GPs are failing transgender patients with a lack of compassion and understanding that must change, according to Dr Helen Webberley

The recent massacre in Orlando served as a grim reminder that discrimination against minority groups continues to play a very real part in our so-called ‘modern society’.

Of course, these episodes are extreme, but while this degree of hatred is mercifully rare, members of the LGBT community have come to accept prejudice as an everyday occurrence. Nowhere is that more true than if you are a trans man or a trans woman.

Every day I hear stories through my online clinic – GenderGP – from members of the trans community, about the battles of bigotry, prejudice and humiliation they face. But what shocks me most, is when that sentiment comes from members of the health profession.

Following significant concerns raised by the House of Commons Women and Equalities Committee in their recent report on Transgender Equality – specifically in relation to the lack of awareness and consideration shown by a great many doctors in treating transgender patients – I was delighted to see the General Medical Council (GMC) publish guidelines on managing transgender patients.

The guidelines state that GPs can prescribe hormones to patients suffering with gender identity disorder, under the following ‘exceptional circumstances’:

 

 

  • The patient is self-prescribing with hormones from an unregulated source 
  • The bridging prescriptions are intended to mitigate risk of self-harm or suicide
  • The GP has sought the advice of a gender specialist and prescribed the lowest acceptable dose

 

 

This was met with a variety of concerns from NHS GPs, and I am disappointed at the reluctance to openly embrace the news that we can now do more to help our trans patients.

Dr Chaand Nagpaul, CBE Chair of the BMA General Practitioners Committee, penned his concerns to the GMC, raising a number of emotive points. His main uneasiness being that specialist prescribing would place GPs in a difficult position, forcing them to prescribe outside the limits of their competence.

In response, Susan Goldsmith, acting chief executive of the GMC, provided reassurances, which included the point that GPs would be expected to ‘acquire the knowledge and skills to be able to deliver a good service to their patient population’. This, she explained, may mean undertaking training. It was clear that the GMC does not consider care for patients with gender dysphoria as a highly specialised treatment area requiring specific expertise.

Goldsmith goes on to endorse a firm view of mine: that these patients actually require very simple care and well-known medication.

The medication for transgender care includes oestrogen therapy used for treating female menopause (estradiol), injections that are typically given to women with endometriosis or men with prostate cancer (GNRH analogues) and a diuretic used for heart failure (spironolactone). Furthermore, anti-androgens used in contraceptives (cyproterone acetate), medication for benign prostate hyperplasia (finasteride) and testosterone replacement therapy, generally used for the management of the male menopause, can also be prescribed.

These are medications that are well known to GPs, and we are well versed in their potential side effects and effective monitoring.

So why is it that GPs are reluctant to take this on? There have been some well-publicised legal cases of doctors trying to help transgender patients – Dr Russell Reid was criticised for a lack of caution in initiating hormonal and surgical gender reassignment treatment, without more careful and thorough investigation and assessment. Meanwhile, his successor, Dr Richard Curtis, was also subjected to a lengthy investigation.

Fear of litigation is at the forefront of any doctors’ mind, but should this impair our duty to help our patients in the best way we can? GPs prescribe hormone patches for menopausal symptoms regularly, but if a trans man asks you to do the same, the response he experiences is often one of horror.

Not all trans people want to go through lengthy assessments, procedures, hoops and surgery – they just want the right hormones to suit their true gender.

These are actually very safe treatments, and delays in receiving care from GPs and NHS gender clinics mean that people are turning to illegal sources and unsafe forms of medication. In the very worst cases, death appears to be the only answer.

The other essential aspect of transgender care is listening, hearing, caring, educating, protecting – bread and butter to GPs. Often the key healthcare provider for the transgender patient, however, is an endocrinologist. Experts in their field yes, but have they honed their patient skills to the same extent as a GP? I would argue not.

So many of my patients tell me about the long journey they have to take, before even feeling brave enough to confide with their GP that they are suffering from gender variance, only to have their feelings dismissed or told that they will ‘grow out of it.’ 

 

Carry On Doctor

 

I have the following simple advice for GPs, which might just help any transgender patients they may come into contact with.

 

  • If you don’t know, look it up. There are many training resources and literature sources on gender care. Go to elearning.rcgp.org.uk/gendervariance
  • Listen to your patients, they are not mentally ill, they are gender incongruent
  • Their medical needs are often very simple – some hormone replacement therapy and a listening ear
  • The treatments are those that we use every day – put any prejudice aside and, if you think your patient is suffering from gender variance, get your prescription pad out
  • The cost of treating these patients is far less than the loss of life and distress caused by refusing them very simple, basic care

 

 

Dr Helen Webberley MBChB MRCGP MFSRH is a GP specialising in the treatment of transgender patients on the NHS and via her private online clinic. Go to gendergp.co.uk

 

 

An online petition calling for a reduction in waiting times for appointments at Gender Identity Clinics currently stands at over 5000 signatures. Add your signature to the petition.


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Features

Making a packet: What would make you take drugs?

by John Pinching 7. August 2016 14:23

 

Why the human spirit must be reflected by pharmaceutical drug packaging

There is a suggestion of communism in the way prescription drugs are packaged. Apart from the odd conservative flourish, like a coloured line, our life-saving pharmaceuticals arrive in steadfastly plain and, invariably, white boxes.

Whether it’s Erythrocin, Viagra, Tenormin or Pioglitazone, you will always get roughly the same container – the blandness only punctuated by the product’s name and a smattering of Braille. In a way, it is a corner of our lives that will forever remain ‘East Germany’, where eggs and shoes and Beatles’ albums were packaged in much the same way.

This stripped back style even became the focus of a Damien Hirst series of artworks. These were created by exponentially increasing the dimensions of the package facade, replacing the product names with items of food such as ‘Chicken’ and exhibiting the results on a gallery wall.

Perhaps this was a clever study of how pharma products have become so omnipresent in our lives that we barely notice them, or that drugs are now as readily consumable as everyday groceries. Alas, I think this was simply an example of Hirst’s own addiction to selling arbitrary art for obscene sums of money  – somewhat ironically in this case, given the criticism aimed at pharma.

Curiously, the design situation in terms of prescription therapies is in stark contrast to ‘off the shelf’ medication, which appears to have licence to use all manner of glowing organs and pain-expunging go-faster stripes on which friendly headache-crusading capsules glide.

One might suggest that the more useless the product, the broader the brush strokes on the associated container. I defy anyone to have experienced relief from a cough medicine, and yet these are among the most flamboyant vessels on the high street – according to the label your windpipe will be draped in a phlegm-consuming ultraviolet blanket and your hack will soon be history. Hogwash – quite literally.

I do think, however, that pharma companies have – through a rather complex set of moral and regulatory reasons – resisted the opportunity to make their products excite, interact or even talk to consumers. I do, however, understand why classic simplicity has been the chosen exterior for so long – in the UK there has been a reticence when it comes to celebrating drugs, as accusations of illicit glorifying hang over pharma like a guillotine. Consequently, industry has had to retreat into an extreme Britishness where cutting edge, disease-curing science is condemned to a white box for eternity.

 

Between the Lines

In spite of pharma’s cautiousness, the government’s stance on how pharma should be presented, could be navigated.

I’m not expecting pharmacists to fire antibiotics out of a cannon, or your dose to be announced by the voice of Tom Hanks, but surely, the appearance of boxes could at least engender hope or excitement or even human spirit.

All the scientific wizardry and creative zeal that goes into the development of a drug grinds to a halt at the packaging treadmill. This habit is unique to our industry – theoretically nothing needs to have a glorious exterior. Cars and buildings could all finish up as white boxes  – but the architects of those products want their invention to uplift consumers. So why are the same principles not applied to pharmaceuticals?

The government document which provides guidance on the packaging of medicines is called Best Practice Guidance on the Labelling and Packaging of Medicines. How plain a box should be is not as dominating as you might think. It appears in item 4.3, thus: ‘Consideration should be given to the line-spacing and use of white space to enhance the legibility’.

The point made in 4.5, however, hints at the reason for pharma’s reticence: ‘The labelling of packs intended for supply against a prescription should include space for the placement of the dispensing label. It is recommended that this should be a blank white space.’

‘Recommended’ – that doesn’t constitute a direct order. You don’t cure cancer because you listen to every recommendation.

The point I am keenest to digest, however, is the tuna mayo, the BLT, the – if you will – cheese and pickle between 4.3 and 4.5. Yes, I’m talking about 4.4 – the optimistic filling between two slices of white. It states: ‘Innovative pack design that may incorporate the judicious use of colour is to be encouraged to ensure accurate identification of the medicine.’

Woah! If that’s not a blatant invitation for pharma marketers to somersault into a loop hole, I don’t know what is. It continues: ‘The primary aim of innovative design of packaging is to aid in the identification and selection of the medicine.’

I would venture to suggest that almost all drug packages are entirely indistinguishable, and that the opportunities clearly stipulated in 4.4 have been ignored due to the ‘insurmountable’ obstacles posed by 4.3 and 4.5.

We’re talking about multi-national companies, surely with a little reinterpretation, some origami and the drive to optimise patient experience, drug companies can waltz confidently into 4.4’s unchartered pastures.

I am convinced that drug boxes featuring scenes from Star Wars would considerably enhance the mission of picking up a prescription. And, if you don’t think George Lucas would be up for that – think again. The whole Jedi ethos is about combining technology with the possibilities of the mind. It could even yield an interactive online  game featuring our favourite characters attacking disease.

How about using album covers to decorate boxes or linking them to a sporting event. Perhaps every time a patient punctures a blister pack it could activate ‘crowds cheering.’ The possibilities are endless.

If I was ill and I went to pick up a box saying ‘may the force be with you’, would I feel motivated – hell yeah!

Tackling illness doesn’t have to be about ‘get drug, take drug, get better’ – it has to involve the human spirit and, if that results in a 1% increase in efficacy, it has to be worth it.

It’s time to start thinking outside the white box. 

 

Illustration by Alex Buccheri

 

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Features

Not nice

by John Pinching 19. July 2016 10:24

Kevin Grogan is in Chicago as delegates launch fierce attacks on their drug pricing systems while kicking ours straight out of the park

The American Society of Clinical Oncology (ASCO) meeting in Chicago once again provided a fascinating insight into the leading research being carried out into tackling cancer but, unsurprisingly, the price of
drugs was a debate that rang around the halls of McCormick Place.

ASCO itself presented a modified version of its ‘Value Framework’ – originally published in June last year – which represents an attempt by the Society’s ‘Value in Cancer Care Task Force’ to develop a methodology which defines the currency of treatment within the context of rising costs, when applied to new and novel therapies.

Development of a software tool to aid cancer therapy decision-making will continue toward a pilot study by the end of the year, with the aim of conjuring up something much simpler for doctors to use while in conversation with patients.

Ah yes, patients. Fair play to ASCO, it is trying to address the problem of patient involvement – but are they a significant part of the discussion? No, I don’t think so.

With this in mind, I ventured out of the congress centre to actually speak to some American patients, and gauge their views on the cost of medicines. They have much to say and about one group in particular – the Institute for Clinical and Economic Research (ICER).

ICER is a Boston, USA-headquartered group, which describes itself as “a trusted non-profit organisation”, and has been in the headlines for a number of analyses. These studies have concluded that drugs are too highly priced and, in May, it focussed on myeloma treatments, stating that the price of some should be cut by as much as 94% to justify their true value.

The methodology used by ICER uses the quality adjusted life year (QALY) measure, which has some similarity to the equation used by the National Institute for Health and Care Excellence (NICE) in England and Wales. In terms of myeloma, its methodology has been slammed by Amgen and Bristol-Myers Squibb and the latter has said that its limitations could set up “arbitrary barriers to patient access.”

B-MS acknowledges that while “assessments of cost-effectiveness may prove useful in comparing treatments,
they have significant limitations”. It added that ICER’s assessments should “not be used for decision-making that determines access to innovative medicines”.

The problem is that they are being used for decision-making, according to Bob Goldberg of the Center for Medicine in the Public Interest. He told Pf Magazine that the NICE comparison is not particularly accurate, as the process in the UK is open and involves robust science-based dialogue. “What ICER wants to do is limit the spending on medicines to pay for roads, bridges and police. I find that to be offensive – I can’t get my mind around it”.

He also stresses that the headline list prices of products give a false picture, and further negates ICER’s flawed models. Discounts of 30%–50% are commonplace, because of rebates that drug companies provide. These rebates, however, worth billions of dollars, and are arguably being trousered by insurers and pharmacy benefit managers. Meanwhile, patients in the USA are being forced to pay 30% of the list price out of their own pockets.

Mr Goldberg believes that ICER sees healthcare in terms of cost – he essentially sees it as an investment. He acknowledges that cancer costs are increasing, but that is mainly because people are living longer, thanks to increased survival rates.

Is ICER therefore saying that survival is a problem? Quite the opposite, as it means that more people are alive to pay taxes.

At an event held at the home of the Chicago Symphony – concurrent with the ASCO conference – Jonathan Wilcox, co-founder and policy director of Patients Rising, said “the so-called ‘value-frameworks’ by ICER, and others, could re-shape the future of healthcare”.

He added that they “use complicated mathematical formulas to put arbitrary limits on the cost of new treatments.”

“The proposals could potentially harm the health and well-being of the millions of Americans with cancer and other life-threatening diseases,” he concluded.

 

We are not worthy

 

Would following the example of NICE be better for our friends across the Atlantic? No thanks, says the brilliantly-named Stacey Worthy, director of public policy for the Aimed Alliance, who was also at the Chicago Symphony event.

She has authored a report claiming that under NICE’s model, “priority in the UK has changed from providing healthcare to all consumers, to dividing up the care that is available, and distributing it equitably, regardless of individual circumstances and needs – the institutional rationing of healthcare. The same can be expected in the USA if insurers implement ICER’s price controls”.

Worthy believes NICE has led to “decreased quality of care, delays in treatment, increased mortality rates and a stifling of innovation”. Arguing that NICE has not approved a single breast cancer drug in the last seven years, she said, “England is a decade behind the other countries in Europe in terms of cancer survival rates”.

At present, England’s cancer survival rates are 15% lower than the USA’s rates. “We cannot afford that to happen here”, she added.

Worthy thinks that if the US healthcare system moves closer to the model on our side of the Atlantic, it will lead to higher mortality rates and poorer quality of care for patients. This may yield a short-term budget impact, but the long-term cost would be terrible for patients, Worthy insists.

Scorching words, but one thing is clear, the patient’s voice in the USA is getting louder and resistance to drug rationing will be ferocious.

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Features

Head start: The mental health challenge has begun

by Claudia Rubin 18. July 2016 08:02

Mind matters: Claudia considers one of the greatest challenges of the modern age

 

There are some things we all know – healthcare costs rising, is one of them. Total healthcare expenditure in the UK from public and private sectors was £150.6 billion in 2013, having been only £54.9 billion in 1997. This equates to a ‘per person’ spend of £2,350 in 2013, more than two and a half times the level in 1997, when £941 was spent for each UK resident, according to ONS data.

Obvious explanations for these rises – like the ageing population, medical advances and patients’ greater expectation of their health – are not offset by technological change which, unlike in manufacturing for example, can only marginally reduce health costs.

It’s not often that a whole new area of health emerges that has the potential to impact healthcare services, and shape the thinking of policy-makers, across the board. The focus, however, that is now given to mental health is markedly greater than just five years ago, and has the potential to disrupt established healthcare norms.

As an indicator of its growing political capital, the term ‘mental health’ was mentioned 162 times in House of Commons debates from June 2005 to June 2010, compared to 847 times from June 2011 to June 2016. A massive achievement for those campaigning to get recognition and critical exposure for mental health sufferers.

It is also delivering results. There has been a near-universal acknowledgment of some basic requirements and a commitment to increasing services. 

In 2011, the government set an ambition that mental health would be valued as much as physical health. In October 2014, the Department of Health and NHS England set out standards for access to mental health services that people should expect, and how long they should have to wait for treatment. The government has also committed £1bn extra a year by 2020, which should help one million extra people a year to receive treatment.

Despite government pledges to establish parity with physical health, however, the amount actually spent on mental health by the NHS last year, was just 11.9% of overall NHS spending.

It is also the case that, although standards have been set, and a plethora of policy goals delivered from the highest level, not least the ‘Five Year Forward View for Mental Health’ earlier this year, the full cost of meeting these standards is not well understood.

This is why parliament’s Public Accounts Committee (PAC) – chaired by Labour MP Meg Hillier – has opened a new inquiry into the funding of mental health services. They note that full data does not exist to measure how far the NHS is from meeting the new access and waiting time standards, but it is clear that achieving the standards will be a very significant challenge.

Despite seemingly never ending increases in funding for healthcare, there are massive gaps in funding at almost every level. The Kings Fund offers a good explanation; “Between 2009/10 and 2020/21, spending on the NHS in England will rise by nearly £35 billion in cash terms – an increase of 35%. But much of this increase will be swallowed by rising prices. In fact, around £24 billion will be absorbed by inflation, leaving a real increase of just £11 billion [a 10% rise over eleven years; equivalent to an average annual increase of just 0.9 %].”

So we can see how significantly this new, quite proper, commitment to treating mental health may increase the pressure on budgets. One in four adults reports being diagnosed with a mental illness at some point in their lives. Government has committed to providing additional money, but there will be competition for this funding. CCGs will have impossible decisions in terms of delivering mental health commitments without sacrificing other services.

This is where the developing field will impact upon everyone invested in healthcare delivery in this country. Since the Commons PAC inquiry opened in May, almost 100,000 testimonies have been submitted by the public, emphatically highlighting the lack of NHS services.

Where cancer funding once had to compete with heart disease, and then with huge levels of spending on dementia, into the mix comes the realisation that mental disorders are not restricted to the ageing population, but of critical importance through school years and beyond.

 

Dual complications

There is no mutual exclusivity at play with mental health. Chronic pain, illness or weight problems; these physical conditions may be complicated by associated mental health concerns, and successful treatment of the former can be impossible without addressing the latter.

In 2014-15, 3.3 million people were known to be suffering from depression. Building the mental health workforce is a challenge, and an expensive one. Evidence from past initiatives indicates that it takes years to embed change successfully across the health system.

Typically the pharmaceutical industry has had a smaller stake in mental than physical health, though there are a range of medications available for its treatment, such as anti-psychotic drugs, anti-depressants and mood stabilisers. 

Many of these have attracted controversy for prescribers and manufacturers, with growing levels of addiction to opiates and benzodiazepines adding another dimension for policy-makers. As the government pushes the NHS to deliver higher standards, the Prescribing Observatory for Mental Health (POMH-UK) – which aims to help specialist mental health Trusts improve their prescribing practice – will also grow in importance.

It is likely that the pressure on NHS funding will necessitate greater engagement with mental health from across industry and its partners. 

Though the ABPI’s Pharmaceutical Mental Health Initiative (PMHI) currently comprises just three companies, its description as “a group of ABPI member companies with an interest in mental health” suggests it ought to be larger. Policy-making in the health sector must increasingly take a holistic view from across health and social care, and it is advisable that we all engage better with how the NHS delivers vastly improved mental health outcomes.

 

Claudia Rubin is a Government Affairs Strategist at Decideum. Go to decideum.com

 

 


 

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Features

Pf Magazine: July issue out now! Read it here.

by Hazel Lodge 12. July 2016 14:06

 

 

 

 

 

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Features

Smoke and mirrors: Filthy habit and grizzly killer

by John Pinching 10. July 2016 08:49

July issue of Pf Magazine out now. Read online here!



A filthy habit and a grizzly killer that reflects our most unpleasant yearnings. 

Sir Walter Raleigh has got a lot to answer for. This lauded chap from the olden days brought us potatoes and tobacco – fags and chips. Two of Britain’s biggest health burdens. Thanks for that, Walt.

It is cigarettes that have wreaked most havoc, however, and they continue to reek to this day. Relationships, marriages, friendships have all gone up in smoke.

Meanwhile, smoking has been keeping the NHS and pharma busy for decades, as cancer, heart disease, strokes and emphysema have discarded millions of people into the ash tray of oblivion. Industry continues to plough billions into researching and delivering treatments for those with smoking-related diseases, while increasingly concentrating on areas of prevention – but shouldn’t pharma’s focus be on making life better for people who do have disease, but don’t smoke?

 

Heart of darkness

When I was growing up in the 1980s, iconic images, such as James Dean – squinting into an uncertain future, made smoking irresistibly exotic, while the striking packages were an early example of how mesmerising graphic design can be.

My generation, however, were the first to have some seriously disturbing information to contend with, as doubts crept in about how ‘cool’ smoking actually was. Public information films warned of the ‘natural born smoker,’ born with an addiction to nicotine. People also started to die from cancer, as a result of starting in the ‘30s and ‘40s. The impact was negligible, as children were seduced into a habit that was flaunted by their parents. Smoking was in offices, pubs, streets, in advertising and in our homes.

Smoking is also a notorious passion killer. I once told a former girlfriend that she had to choose between her & I, and Benson & Hedges. To this day, if I need to summon contempt for a smoker, I channel the feeling of being metaphorically stubbed out after issuing what was a very reasonable ultimatum.

The entitlement and the self-righteousness of the smoker is the real burden on the NHS and pharma’s priorities, because it guarantees a long succession of tumours. There is no such thing as a considerate smoker. Smoke, by its very nature, goes where it pleases, regardless of explicit signage. I do believe in the basic human right to indulge, as long as it doesn’t kill me. People can drink and abuse drugs at their own risk, because it’s not mine. But each and every time someone ignites a cigarette they are making a conscious decision to kill, not only themselves, but me – us – as well.

With this considered, it seems utterly preposterous that in 2016 smoking is still legal – we are still subjected to the grey-faced dystopian tribe of doorway chokers making an enemy of their own future, and many willing to do so in a phony war they can’t possibly win; their principles as thin as the paper around their tobacco.

The people who fail to see the misery that their habit is weaving, end up as the half-ghosts, outside hospitals, pulling along their drip trollies with one hand, and nursing a smouldering dog end with the other – the last days burning away in a grotesque plume. The final insult.

Our sympathy must cease – why should anyone in a modern, civilised world tolerate smoking?

I have seen the new plain cigarette packages and, yes, graphic illustrations of disfigurements and cancerous decay are hideous, but is it enough? If the government refuses to ban smoking then they must restrict it to nicotine prisons, into which smokers can climb, but out of which smoke cannot escape.

In the final analysis, you wouldn’t invite Jack the Ripper to a hen night and expect him to be back by seven, so why would you expect a smoker to act responsibly in the presence of passive bystanders. I can draw little distinction between a serial killer and someone who insists on smoking.

 

Quitters 

For smokers who have seen the utter futility of what they are doing, help is at hand. Healthcare professionals are only too willing to help them, when it seems the will to live isn’t strong enough. Here are the thoughts of key sympathisers.

“Smoking cessation medicines have been shown to be one of the most effective methods to stop smoking, when combined with support from a healthcare professional. As pharmacists, we are often the point of contact for smokers, many of whom get stuck in a cycle of trying to quit with no NHS support, and not succeeding on other therapies, like NRT. Pharmacists in the community or hospital are in ideal locations to offer evidence-based advice to help smokers make an informed decision.”

Darush Attar-Zadeh, Respiratory Lead Pharmacist Barnet CCG

 

“As nurses, we are often one of the first points of contact for people looking to quit smoking – whether in a GP surgery or at a smoking cessation clinic. The findings from the EAGLES study highlight the benefits of smoking cessation medication and provides us with key information to help us have informed conversations with our patients who are looking to stop smoking.”

Tracy Kirk, respiratory nurse consultant and primary health care educator.

 

EAGLES has landed

Pfizer has flown into the smoking den by releasing its EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) data. The study is the largest placebo-controlled trial to compare the neuropsychiatric safety and efficacy of ‘varenicline’ and ‘bupropion’ with placebo and nicotine patches.

The results demonstrated that the use of varenicline or buproprion in patients, with or without a history of psychiatric disorder, is not associated with an increased risk of serious neuropsychiatric adverse events. In addition, patients taking varenicline showed superior continuous abstinence rates at weeks 9–12, and 9–24, than patients treated with placebo, bupropion or nicotine patch. Furthermore, patients treated with each of the medications had higher abstinence rates than those treated with placebo.

Robert West, Professor of Health Psychology, University College London and co-author of the EAGLES study commented: “This study should reassure regulatory authorities, doctors and patients about the safety and effectiveness of medicines to help smokers stop. Every smoker should receive the offer of evidence-based support to stop at least once a year – currently most do not.”

EAGLES also included an efficacy objective to determine smoking abstinence rates in patients. The results showed that patients with and without a history of psychiatric disorders, taking varenicline, had significantly higher continuous abstinence rates than patients treated with bupropion or nicotine patch. Those treated with each of the medications had higher abstinence rates than those treated with placebo during both time periods.

Dr. Berkeley Phillips, UK Medical Director, Pfizer, commented, “EAGLES adds a significant, additional body of important safety and efficacy data for varenicline in a large population of smokers. At Pfizer, we remain committed to effectively supporting smokers throughout their journey to stop smoking.”

 

Murder most foul

When it comes to destroying lives and, ultimately, ending them - nothing gets close to smoking.

Global yearly death toll 6,000,000

10,000,000 yearly deaths across the world by 2030

One billion deaths by end of the century

In 2012-13 460,900 hospital admissions were attributed to smoking in the 35+ age group – accounting for 5% of all admissions.

Half of all long term smokers will tie prematurely, losing ten years, on average.

In 2013, 17 per cent (78,200) of all deaths in adults aged 35 and over, in England, attributable to smoking (around one in six).

Data provided by ash – action on smoking and health

 

Illlustration by Alex Buccheri



 

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Features

Human league: The mystery of the microbiome

by Amy Schofield 4. July 2016 10:00

 

You’re all human, right? Wrong. You are merely host to a 100 trillion microbial cells that make up the majority of your earthly form, primarily housed in your gut. These microscopic microbial life forms – known as the microbiota – outnumber our own cells by about 10 to 1, and the genes within these cells are collectively known as the ‘human microbiome’.

The microbes’ role in the gut is the focus for a growing body of research that is exploring the profound influence on our health caused by the composition of these curious imposters. What we put into our bodies – from food to antibiotics – could create conflict between gut microbes and the humans they interact with, leading to disease.

A holistic understanding of the microbiome in human health is emerging as the key to tackling many challenges facing humanity in the twenty-first century, including the prevention and treatment of disease and infection.

 

Super natural

The concept of the human microbiome was first introduced to the scientific community by Joshua Lederberg. He defined it as ‘the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space and have been all but ignored as determinants of health and disease’.*

There are millions more microbial genes than human genes in the human/microbiome superorganism and this vast array of microbes first colonises the human body at birth.

It is the way in which the genes within these microbes interact with you – their genial host – that define their ultimate role in our existence, whether it be nurturing good health or taking on disease.

 

Brain food

We have a symbiotic relationship with our gut bacteria – providing them with a protected, nutrient-rich habitat. They break down the food we eat to produce energy, make essential vitamins and act as the first line of defence to fight off marauding pathogens. Scientists are just beginning to understand our relationship with microbes, and research is recognising the microbiome as a newly-discovered organ, about which there is much to learn.

Currently, a number of conditions are associated with an imbalance of gut microbes, including inflammatory conditions, food allergies and cardiovascular diseases. Food choices, antibiotics and the regular use of antibacterial lotions and soaps are thought to kill the ‘good’ bacteria, and allow the ‘bad’ bacteria to thrive. This then disturbs the balance of the microbiome, which can lead to immune reactions and digestive issues. Potential treatments are aimed at addressing these imbalances and restoring health.

 

Yak cult

Nobel laureate Elie Metchnikoff introduced the concept of probiotics to the scientific community, publishing a seminal report linking the longevity of Bulgarians with consuming fermented milk products containing viable Lactobacilli.** This suggested that certain microbes, when ingested, could actually be beneficial for human health.

Shann Jones owns a goat farm in Wales, where her family business produces ‘kefir’ – a live culture-fermented goats milk product – which acts as a powerful probiotic. It is thought that probiotics can heal a plethora of health problems, including eczema, asthma and infection.

Shann and her husband, Rich, have joined forces with the Institute of Biological, Rural and Environmental Sciences (IBERS) at Aberystwyth University. IBERS’ Director of Research and Professor of Animal Science, Prof. Jamie Newbold, has a research interest that focuses on the effect of probiotics on the structure of microbial populations in the gut, and he genetically strained and tested their kefir. The research demonstrated that the product was found to be effective within the human microbiome, as well as the equivalent in dogs and horses.

 

War and peace 

As with any host/guest arrangement, sometimes things go awry and conflict breaks out. When the needs of microbes and humans are at odds – due, for instance, to a poor diet – gut microbiota may contribute to chronic conditions, or use nutrients intended for the host, causing inflammation and other negative health effects.

Recent research published in Annals of the New York Academy of Sciences examines the role of microbes in the gut. The study – led by Athena Aktipis – researcher at Arizona State University’s Biodesign Institute, explores how the food we choose to eat either promotes cooperation or fuels conflict between gut microbes and their human hosts, leading to health or disease. 

“There are certain foods that lead to resource-sharing between us and our microbes, while other foods can lead to conflict and resource competition between our bodies and our microbes,” Aktipis says. “This cooperation and conflict framework can help us understand certain aspects of why we get sick and how we can stay healthy.”

 

Come together

Although research into this exciting area is increasing, a lack of coordination is concerning those involved. The authors of a report published in Nature – ‘Microbiology: Create a global microbiome effort’ – are calling for a cohesive government-led microbiome research programme to get past “national silos” and “gain universal insights that will benefit all humankind.”

In May, the White House revealed that it was launching the $121 million Microbiome Initiative, a nationwide project to coordinate and fund microbiome research.

Meanwhile, research into the human microbiome continues apace around the world. Unlocking the role that these myriad microbes play could mean a revolution in how we prevent and treat disease.

* Lederberg and McCray, 2001

** Metchnikoff and Mitchell, 1907

 

The Stats

Microbes outnumber human cells 10 to 1

Human microbiome = 8 million genes

It’s 300 times larger than the gene set in the human genome.

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The high fives of Innovative cancer treatments

by Amy Schofield 22. June 2016 08:06

 

1 CANCER IMMUNOTHERAPY

Treatments that harness the inherent powers of the immune system to fight cancer are hailed as the most promising new treatment approach, since the development of chemotherapies in the late 1940s.

The process selectively targets and kills cancerous cells, without damaging healthy ones, meaning fewer side effects. Recent experimental research into CAR T-Cell therapy on patients, with acute lymphoblastic leukaemia, found that the symptoms in 94% of participants with this blood cancer completely disappeared.

The approach is universal, and can be used to treat almost all cancers. The ability of the immune system to ‘remember’ means that immunotherapy could also offer long-term protection against cancer.

 

2 NANOTECHNOLOGY

Nanotechnology is one of the hottest new areas of medicine, based on microscopic particles, with distinctive properties related to their chemical structure, mobility, and ability to absorb energy.

In South Australia, nanotech ‘smart packages’ - delivered with chemotherapy drugs - have been found to target and destroy cancer cells, while reducing side effects. 

The minuscule ‘trojan horse’ vehicles are 100 nanometres in diameter, and contain folate molecules which find and attach themselves to cancer cells. Anti-cancer drugs in the smart packages are then released, killing cells in the process.

 

3 TARGETED MEDICINES

These interfere with the specific molecules - molecular targets - that are needed for tumours to grow, progress and spread. As a monotherapy, targeted medicines are already a formidable addition to the cancer-fighting arsenal. 

Therapies act on specific molecular targets, associated with cancer, and are deliberately selected to interact with their target, without destroying surrounding healthy cells.

They do have their limitations however - one of which is the risk of cancer cells becoming resistant to the treatment, for example through mutation. Which brings us on to combination therapies.

 

4 CANCER COMBINATIONS

Combination therapy has been a hallmark of cancer treatment for years, as a way of killing cancer cells and halting the progression of the disease.

Earlier this year, research on 257 women showed that the combination of two drugs - lapatinib and trastuzumab - could shrink, or even eliminate, breast cancer tumours in 11 days. Around a quarter of women with aggressive HER2 positive breast cancer benefitted.

Professor Nigel Bundred, Professor of Surgical Oncology at the University Hospital of South Manchester, said: "This has ground-breaking potential.”

 

5 VACCINES

The HPV (human papilloma virus) vaccination, which protects against cervical cancer, is already widely offered to 12 and 13-year-old girls, as part of the NHS childhood vaccination programme. 

A unique phase one trial is now underway to test a new cancer vaccine, designed to harness the power of the immune system to destroy tumours, wherever they are in the body. The trial will run over the next two years and involve up to 30 volunteers.

The vaccine contains a small fragment of protein from an enzyme called ‘human telomerase reverse transcriptase (hTERT)’. This enzyme allows cancer cells to continuously divide.

By injecting the antigen into the patient, along with a low dose of a chemotherapy drug, it is hoped the immune system response will be stimulated, making antibodies that will kill cancer cells, but leave healthy cells alone.

 

Facts and stats:

Worldwide:
14.1 million people a year worldwide are diagnosed with cancer

8.2 million of those will die

That is one person every 4 seconds dies

Deaths from cancer are expected to double by 2030*

UK:
2.5 million people in the UK have cancer

Over 300,000 people are diagnosed with cancer each year

Over 160,000 people a year die of cancer

Breast, prostate, lung and bowel cancers together accounted for over half of all new cancer cases in the UK in 2013

42% of cases are preventable*

 

*From cancerresearch.org

 

 

 

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Features

AIDS: death sentence to daylight

by John Pinching 6. June 2016 09:10

Chastening AIDS into submission is surely man’s greatest achievement.

In many ways HIV/AIDS was the classic horror film set up. A community suddenly and inexplicably targeted by a demonic predator. It was Halloween, it was Jaws and it was any number of vampire movies. And it was made all the more terrifying, because this enemy came without a name or a face. 

The HIV/AIDS plot began 35 years ago in California. After years of secrecy the gay community had started to find its voice, coming out in a whirlwind of art, music, nightclubs and, understandably, sexual defiance. The new generation of homosexuals were no longer prepared to endure prejudice and, instead, flaunted their physiques, and expressed freedom through promiscuity.

By 1981, however, a mysterious illness threatened to ruin the party. Predominantly young, gay men were dying from a new virus, defined by a period of sudden weight loss, lesions and the shutdown down of a hitherto healthy immune system. The situation triggered panic, and also prompted celestial posturing from those who pronounced it ‘a punishment from God’. The ignorance was almost as harmful as the illness itself.

By the end of that first year, 152 deaths had been recorded, but it was an isolated fatality that most puzzled the scientific community, for one of those infected was not a homosexual, but an intravenous drug user – the first indication that this condition impacted on everyone.

The gay community’s reaction was impressive and they called on an already finely-tuned expertise in activism. Even in the throes of unimaginable suffering they marched, campaigned for accelerated treatment approvals and lent themselves to cohort studies. While some refused to give up their sexual liberation, others wanted to help those they left behind. It was altruism in its purest form.

Meanwhile, in the UK, immunology departments braced themselves as the ‘new disease’ crossed the Atlantic. Amazingly, one of the first diagnosed cases was not a sexually reckless homosexual, but a ‘normal’ housewife, with only one sexual partner (her husband) – this was the moment the ‘gay problem’ became society’s problem. 

By 1982/83 the mysterious condition had a name – ‘acquired immune deficiency syndrome’ – and an unforgettable acronym; ‘AIDS’. Experts in the UK attempted to educate the public with a polite letter, printed in national newspapers, but, after it failed to receive attention, a shocking information film was broadcast, which left nothing to chance. The word AIDS was chiselled into a tombstone, lilies were tossed on a grave and a chilling voiceover told you the deal.

There were also a few high profile deaths, but it was Rock Hudson’s, back in the US, that convinced any remaining cynics that this was serious – a symbol of enduring strength was dead, and he had died of AIDS.

In 1987 the first effective treatment – a nucleoside reverse transcriptase Inhibitor (NRTI) – called AZT, began to be widely used and, thereafter, a flurry of anti-retroviral therapies emerged, as pharma’s mission came into sharp focus. While these treatments temporarily fooled the replication system of the virus, patients would eventually be overwhelmed, and die from AIDS-related complications. 

The 1990s heralded wider solidarity against a common foe. Freddie Mercury’s death raised awareness further, while the tale of two very different Johnsons – Magic and Holly – proved that there was life after a positive result. The former, a hugely popular basketball star, and the latter, the charismatic lead singer of Frankie Goes to Hollywood, have fought the disease in the public gaze, and are both alive in 2016. 

Campaigns continued through a number of female figureheads, notably Princess Diana and Elizabeth Taylor, and the red ribbon became a fashion statement – disease awareness was immersed in pop culture in a way that had never been seen before.

In the second half of the decade indinavir – a protease inhibitor – was combined with two existing NRTIs, and the game changed. It suppressed the virus indefinitely and frequently rendered it undetectable. Thousands of people avoided death, illness and even hospitalisation, as a stranglehold on AIDS was established and it became a long term treatable condition. 

The single pill therapy, REZOLSTA, has recently become available for HIV-1 patients, and represents a significant move towards better treatment discipline, in an area which requires at least 95% adherence. Meanwhile, the brilliantly-abbreviated PrEP (from the not quite as sexy, ‘pre-exposure prophylaxis’), is a controversial combination of tenofovir and emtricitabine, which blocks the setting up of an infection, in HIV-negative individuals. It has been argued that people will abuse it in a sexual frenzy, whereas I would suggest that all alternatives to getting AIDS should be celebrated.

Indeed, in the great tapestry of human behaviour history will remember HIV/AIDS, not by mankind’s struggle, but how it reached unchartered heights of humanity. How ‘we’ have dealt with it – as healthcare professionals, as pharma and – most resolutely – as people, has set the template for how all diseases should be approached. 

In the final analysis AIDS/HIV has been a most profound study of the human condition but, curiously, it has not been so much about death, as what it is to be alive. 

 

Witnessing history

John Pinching talks to Professor of Clinical Immunology Professor Anthony Pinching about his reflections on HIV/AIDS.

 Prof. Anthony Pinching, witnessed the arrival of AIDS, treated its earliest patients and saw at first-hand how the story unfolded. 

1. How satisfying is it to you personally that HIV/AIDS is now a treatable long term condition rather than a death sentence?

In the early 1980s, when we started to see this condition in the UK, a patient being diagnosed as having AIDS had an average life expectancy of some nine months. While some died sooner from their first presenting illness, others lived quite a bit longer – I remember some living for as long as three years. Once we were able to identify people with HIV infection, before they were ill, we recognised that they could remain well, and without immunodeficiency for many years, although there was a steady and relatively high rate of progression to AIDS over 5-10 years of follow-up.

Initial treatments were based on treating presenting opportunist infections and tumours, and maximising health and well-being, together with adjustment to the condition and its prognosis amongst a generally young group of people. This could achieve a certain amount in treating acute events, and maximising health inbetween bouts of illness, but the underlying condition would continue to progress.

We then saw single-agent anti-retroviral therapy (zidovudine) making a small, but useful, difference in life expectancy, initially demonstrated in those with AIDS, where it almost doubled. It was later shown to help people with HIV infection and adverse prognostic markers, leading to lower rates of progression.

The breakthrough – and it really was that – came with the clinical trials, demonstrating the impact of combination anti-retroviral therapy in the mid-1990s. While the theoretical concept was logical and attractive, the actual impact was unexpectedly massive. It transformed life expectancy, and indeed the whole landscape of HIV/AIDS treatment. We were surprised and delighted to see the extent to which the immune system could recover when HIV was effectively suppressed. What had been, in effect, a terminal illness, became a chronic treatable disease, with life expectancy increased by more than an order of magnitude. The impact on individuals and on populations were remarkable for those of us at the front-line.

Studies subsequently have consolidated this impact, refining the approach, and optimal timing of intervention, monitoring treatment impact, minimising side-effects and maximising convenience and adherence, as well as showing reductions in HIV transmission from effectively treated HIV-infected persons – most strikingly in mother-to-infant transmission. 

As someone involved in treating patients from the outset of the pandemic, this change was truly extraordinary to witness. It was a very satisfying outcome to all the enormous investment of ideas and money, by many people and organisations across the world. As a clinical researcher, it was great to see how the systematic pursuit of clinical research had achieved such results in such a relatively short time. As someone involved in public policy, as well as helping in addressing the challenge of HIV in Africa, it was immense, and heartening. It was especially good to see these treatments made available in Africa and other developing regions, contrary to early predictions.

2. Are you surprised at the relative speed at which it has happened?

The pace of the improvements in HIV/AIDS treatment –  in real time – seemed frustratingly slow because, as clinicians, we saw the immediacy of need in our patients, and yet we had to do our best with more limited tools, while the necessary research was done. From a wider perspective, however, the speed with which we went from first recognition of the disease (1981), to first HIV tests (1985), to first effective treatment (1987), through to combination anti-retroviral therapy (1996), was unprecedented.

It required massive investment, great focus, and tremendous collaboration between scientists, clinicians, the pharmaceutical industry, governments and – above all – patients. It showed what could be done with that sort of focus and collaboration. It wasn’t easy – indeed it was quite ‘bumpy’ at times, but we got there!

3. Do you think the social stigma regarding HIV/AIDS has lifted in recent years?

Yes, to a substantial degree, although there is more to be done. Extraordinary work across many sectors, important community advocacy, valuable public policy changes, and cumulative shifts in society have all played a part in reducing stigma. But problems remain in a number of respects in the UK, and even more so in other parts of the world. It will take a generation or two to get to where we need to be, but there has undoubtedly been change for the good, and some came surprisingly soon. The response to HIV/AIDS has also had a positive impact in reducing stigma and discrimination for people with a wide range of other health problems.

4. Do you think it's possible that a cure could emerge in the next decade?

‘Cure’ is not a helpful word for most diseases – it has a very particular meaning, signifying something that is very rarely achieved with chronic disease. I do think that what has already been achieved for HIV/AIDS, however, represents something of the same order: an eminently treatable chronic condition that may be compatible with near-normal life expectancy. I wouldn’t have imagined much of what has transpired!

Professor Anthony J Pinching, DPhil, FRCP, Emeritus Professor of Clinical Immunology, PCMD

 

Illustration by Alex Buccheri

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