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We can’t go on like this: patients must come first

Published on 27/05/14 at 07:31am
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In the years ahead, targeting treatments will become more understood and accepted by patients

When French pharmaceutical company Sanofi announced the appointment of Dr Anne Beal as chief patient officer in late March, the response among patient advocates was mixed, to put it mildly. 

Her role, according to Sanofi, is to “highlight patient perspective within the firm so that the company’s future products can better incorporate the unique priorities and needs of patients”. Many have welcomed the initiative, the first appointment of its kind by a top 10 pharma company – not least because Beal has impeccable credentials.

But not all were so optimistic, some even saw it as a PR move and rather insignificant given the massive changes that many would argue are required for the industry to become more patient-centric. That reaction was not unpredicted.

We know from our own experience of working with patient groups and health charities that, sadly, ‘mistrust’ and ‘suspicion’ are two words often used in relation to the relationship between patients, service users, carers and pharma companies.

The industry’s reputation is, arguably, at its lowest ever ebb. And this is affecting research. When the Health Research Authority (HRA) ran an Ipsos MORI poll last year, it found that the general public would be least confident about taking part in health research if it was funded by a pharmaceutical company. 

“This lack of confidence is mirrored in the public dialogue workshops also conducted by Ipsos MORI which showed that the public was suspicious of the motivations of the pharmaceutical industry,” the HRA said. But the poll also teased out a number of other interesting findings, including:

• 82% of respondents said they would be confident of being treated with dignity and respect if they were asked by their doctor to take part in a UK health research study

• 74% of respondents said they would be confident of their personal data being held safely and securely if they were asked by their doctor to take part in a UK health research study

• 77% of all respondents would be confident about taking part in a health research study if they knew that it had been reviewed by a Research Ethics Committee

• 44% of respondents said that involving patients in helping to ensure that clear information is given to participants in a health research study could help to increase confidence in a study – however, 49% said it would not affect their confidence in a study either way.

Patients clearly understand the need to conduct research, but these poll findings suggest they just don’t like the pharma industry. This may be partly explained by the fact that over the past year we’ve seen pharma, collectively and individually, kicked hard over transparency about disclosure of clinical trials results – an inevitable result of the emergence of the AllTrials campaign prompted by Dr Ben Goldacre’s book ‘Bad Pharma’. 

Can we honestly say that industry has responded well to such criticism? Meanwhile, the vast sums of money the industry spends on fines and out-of-court settlements for malpractice cause barely a break in step (or a flutter in share prices) for this multibillion pound sector. 

In April this year the Department for Business and Innovation’s Public Attitudes to Science (PAS) report showed that “two-thirds (66%) [of people] are specifically concerned by scientists being too dependent on business and industry for funding”.

It is concerning that the figures coming from the PAS report have trended upwards over the many years it has been produced. The Association of the British Pharmaceutical Industry (ABPI) headlined the most recent report on its website as follows: “‘Mind the Gap’: new report finds growing divide between medicines development and the commercial environment.” But ‘mind the gap’ is a phrase that could just as well be used to talk about the relationship between industry and patients.

Indeed, who is to say that this deep-seated mistrust of the industry is in fact the main reason that companies find it difficult to recruit people to clinical trials, rather than the punishing UK regulatory regime highlighted in this report? It may also undermine public confidence in new modes of treatment, such as personalised or stratified medicine, before they have even hit the clinic or pharmacy. So, tackle this problem we must.

Out-of-sync with patient needs

The challenges that beset our health services and force companies to re-think their business models stem from the same root cause: namely a failure to design themselves around, or let themselves be driven by, the patient. 

Whether it is hospitals or primary care in the NHS, or the research teams in pharmaceutical companies, all one needs to ask is “what does our patient want and what does he or she think?” The answer to this question is the critical factor for success.

In research for a cure, or a drug that extends or enhances life, the focus must be on the patient at every step. But we wonder whether this is normally the case. Of course the ‘end user’ may be in the room and – at the right point in a trial – the impact on the patient as opposed to the disease will be considered. Treatment side effects clearly have to be part of the risk/benefit equation.  

In light of the increasing complexity of therapies and their targets, the impact on patients and their individual experience – and not only the disease’s reaction to treatment – will be a critical factor in creating a successful product. Take bowel cancer, where the good news is that the median survival rate has risen from one to two years in the past decade. 

But these numbers hide the real individual patient stories that tell us patients are living longer, accessing new treatment options and – quite simply – confounding the original expectations of the researchers developing new drugs by living many more years than the trials suggested they would.  

In the years ahead, targeting treatments will become more understood and accepted by patients – the ‘will I need chemotherapy?’ question on diagnosis will be replaced by “what is the right treatment for me personally?”

Individual patients will have to understand treatment processes in some detail, as well as the potential risks and side effects, while doctors make decisions in consultation with them. This is a pressing issue even now, as this following patient’s post on Beating Bowel Cancer’s online patient forum illustrates: 

“Oh my word, I’ve only had two cycles of this for my stage IV colon cancer (with multiple liver metastases) but I’m completely shattered. The regimen has completely derailed me and there are days when I can barely get out of bed, even a week after infusion. I still have four more cycles to get through before the CT scan and assessment for liver surgery. 

“My mouth is also full of sores, making eating difficult (I’m eating a bland, low residue diet that’s easy to swallow), which is annoying because I’m already skinny. I’m using mouthwash and will start gargling with salt water today, but I’m dreading having to endure another month or two with a very sore tongue. Am I really going to feel this rubbish for the foreseeable future?”

To help such patients, Beating Bowel Cancer has produced a simplified decision-making guide that outlines when treatments are used and what for. Alongside this, it has also created a targeted therapies and biomarkers fact sheet, which aims to help demystify the world the patient has entered. 

But, wouldn’t it be better if it wasn’t left to specialist charities alone to try to act as the intermediary between patient and pharma company? If pharma got closer to the patient, not only would trust build between the two, but there also would be real financial benefits. Developing this kind of relationship wouldn’t be easy, but it isn’t impossible. 

Working with patients saves money

More fundamentally and to make use of some management jargon – pharma, other funders and the health service need to ‘get with the programme’ when it comes to aligning their priorities with patient needs as opposed to market assumptions.

Sir Iain Chalmers, a founder of non-profit scientific review organisation the Cochrane Collaboration; and Paul Glasziou, Professor of evidence-based medicine at Bond University, wrote a notable piece about this disparity in the Lancet in 2009.

They quoted the work of Deborah Tallon and her colleagues, who in their 2000 paper on osteoarthritis wrote: “Only 9% of patients wanted more research on drugs, yet over 80% of randomised controlled trials in patients with osteoarthritis of the knee were drug evaluations.”

It is certainly one of the most common questions raised by patients and their families when it comes to research. Drugs are important, as is the work to develop them, but so is the quality of life that might come in the meantime in terms of less fatigue, pain or better services.  

Concerns over the massive waste of money, time and effort by the research community that this represents, has resulted this year in the Lancet running a series of articles on the subject by Sir Iain.

The National Institute for Health Research (NIHR) has also initiated its own ‘Adding Value to Research’ programme, looking at how to increase value in research, from setting priorities to ensuring results are available to patients when making decisions with health professionals about their care.

At the heart of this programme lies a commitment and intent to involve patients and carers more in the definition, design and delivery of research. And the reasons for doing this have as much to do with increasing efficiency and effectiveness in research as with it being the right thing to do.

NIHR is already home to the highly successful James Lind Alliance Priority Setting Partnerships (PSPs) model for bringing patients and clinicians together – to identify ‘treatment uncertainties’ or priorities. Nineteen PSPs have been completed and another 18 are ongoing, with final PSPs now often cited in
grant applications. 

Last year King’s College London published an analysis of over 300 studies supported by NIHR’s Mental Health Research Network (MHRN), suggesting that trials which had strong models of public involvement were four times more likely to set up ‘time to target’ (to use industry’s totemic phrase) compared to those that didn’t.

Black market conversation

Our sense is that, contrary to the understandable assumptions of many colleagues and patient advocates, there are forward-thinking pharma companies out there who understand the changing needs of the patient and patient communities (in some ways more than public funders and academia), recognise the benefits of working more closely with them, and are keen to build a constructive partnerships. 

The ABPI has its own patient forum now and publishes minutes of its meetings. GSK led its competitors in establishing a new system for other researchers to access and analyse their clinical trial data, whilst also signing the AllTrials register.  

AstraZeneca is purported to have established its own patient network in key therapeutic areas with the aim of establishing a continuity of dialogue with patients. Even the currently much-maligned Pfizer has been looking to replicate, in the US, some of the models for involving young people in trial development that have been pioneered by NIHR’s Clinical Research Network (Children). 

These initiatives will not individually or collectively transform the future dialogue between industry and patient, but they may be important stepping stones. Unfortunately, the average patient would be hard-pressed to find out about them. 

Company executives in the UK speak of nervousness that competitors will accuse them of breaking the ABPI’s Code of Practice the moment they as much as breath on a patient. Charities and patient groups are also very wary of declaring the relationships – financial or otherwise – that they have with industry. The resulting black market conversation is to no one’s real advantage. 

Greater communication

Opening up the dialogue must be our first objective. There are three ways in which this might be encouraged in the near-term, with the aim of creating some momentum. First, the ABPI must address the negative impact of its own Code of Practice on patient dialogue. Its current review of the Code is welcome, as is its consultation with charities and patient groups about how it might be best amended. 

There is an equally strong argument for charity associations such as the Association of Medical Research Charities (AMRC), National Voices, and others to develop codes that support, and therefore do not deter, open and transparent dialogue.  

Second, companies must buy into this notion of patients and carers as partners in the design and delivery of the treatments and therapies for tomorrow. If, as they have done in recent years, companies are able to share data and collaborate with each other in ways once thought impossible, they can also afford to share their ideas and see them become more rounded under the critical eye of patients.

Finally – and this may seem a small measure but it is actually part of a much larger goal – patients must become part of the wider discourse about medicines and their development. 

This would entail companies collaborating more among themselves as well as with other funders, in order for patients to attend meetings, events and conferences from which they are barred because of cost. Once all parties are included in the conversation, the conclusions of that dialogue are more likely to be actionable for all.

Getting serious about ‘patient power’

With great timing on April Fool’s Day – the day before Beal became Sanofi’s chief patient officer – the new NHS England chief executive Simon Stevens started his first day in the job. In his inaugural statement he said that  it was “time to get serious about patient power”. 

The context was supporting patients to take better control of their own health, but Stevens could have been talking about any aspect of delivering health and social care – including research, and the development of better medicines and treatments for patients.  

As Stevens says, ‘patient power’ is a serious issue. In our view it is foolish to not take the patient seriously in pharma – or any other aspect of healthcare. As with Sanofi’s announcement, the response to Stevens was mixed. After all, how many times have we heard such proclamations by senior civil servants and ministers? 

We can both remember the (too many) health bills which became the health acts that declared the patient would be put at the heart of the NHS. We are also both amazed when we look at industry platforms – the ABPI conference, for example – that do not have at least one patient speaker. 

There needs to be a change. We need to take Stevens at his word and help him with suggestions for how real patient power can be made to happen. We need to applaud Sanofi for their boldness in appointing a chief patients officer – and then ask the company to deliver. Beal needs to be a visible advocate for change and not someone lost in the clinical trials process.

But, then again, to lead such fundamental change in their organisations they will first need our support and not our cynicism – we, and others, should be ready to work with them.


Simon Denegri is NIHR national director for public participation and engagement in research and chair of INVOLVE. 

Mark Flannagan is chief executive of Beating Bowel Cancer. He has been a non-executive director of a sustainability and regeneration charity, and has been a member of several Department of Health/NHS England advisory groups.

Both authors are writing in a personal capacity and the views expressed here may not necessarily reflect those of their respective organisations.

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