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The truth, the whole truth and nothing but….pharma

Here is a gripping report from this week’s ‘Adweek’ (based in New York) about the new marketing strategies being used by pharmaceutical companies.

Don’t be put off by the reference to ‘Obamacare.’ The story is equally applicable to the United Kingdom.  For it is essentially a tale about how disease is being re-packaged. Patient data is the new currency, social and digital media the marketplace.  Companies are no longer selling potions and pills but offering an all-round ‘service’ to patients and health professionals.

The speed with which the private sector can move in this way is dizzying (I thought I was doing well this morning by getting someone to agree some terms of reference!).  The sums of money at their disposal, mind-boggling.  In fact, the implications of what is happening can feel overwhelming.  So much so that it is easy, all too easy, to put on one’s ‘Blockbuster’ voiceover just to up the threatening atmosphere.  Yet who isn’t chilled to the bone when a commentator can glibly say in print:

‘For years Lilly has owned diabetes.’

Has anyone told people with diabetes and their families this?

I am sure that many patient advocates will be worried by the scale and speed by which these new approaches are heading our way.  But we seem to be in a collective state of un-readiness for this latest chapter in the marketization of health or selling sickness.  Or are we just complicit?  Either way it makes the work of organisations such as ‘Selling Sickness’ or Sense about Science as well as advocates such as Margaret McCartney  who are calling attention to these trends, all the more important.

How will patients be able to source independent advice when the market is smothered by ‘Trojan horse websites’ or apps backed by pharmaceutical companies? How will they be able to identify truths amidst this morass? Can regulators realistically be expected ‘protect and promote’ the public interest in the digital age using the same carrot and stick approaches that have failed in the past?  We have barely begun to think through the consequences.  Let alone the solutions.  And yes, these have to involve the companies themselves.

The danger is that we continue with our obsessions about things like the best model for lay reviewing when such bigger changes are afoot; we can only stay entrenched in land wars about whether something is public involvement versus participation versus engagement for so long surely?  Let’s not allow ourselves to become so tamed within our own boundaries that we lose the art of thinking beyond them and tackling new challenges?  Otherwise it will all be over when we finally do wake up.

In the meantime, we should remember, there’s no such thing as a free app….

An unleaked memo on sorry pharma and the silly season

Or should that be silly pharma…I don’t know.

Yes, our colleagues from pharma have stolen the march on everyone else and got the silly season off to a grand old start.

I am referring, of course, to the leaked memo from the European and American pharma trade associations dutifully covered by Ian Semple at The Guardian on Monday. The memo lays out a strategy for heading off the campaign for greater transparency in clinical trials data (as successfully spearheaded by AllTrials) which includes getting patient groups to front the pharma counter-offensive. Article here: http://m.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trials

You know there are all sorts of things that occur to me when I read these sorts of reports. In no particular order:

  • It reads like the sort of technically brilliant but politically stupid thing I might have written as a lobbyist (yes, sadly, I was one of those) twenty years ago.
  • I seem to remember that the MP who I worked for even longer ago than that, refused to take any call or read any letter written by someone fronting-up a campaign or cause on behalf of another.  ‘If they can’t speak to me direct then…’ he would say. Perhaps if more legislators took that line today we would see a rapid change in the practices of our lobbying industry – way beyond that which a register or legislation is likely to achieve.
  • Back to pharma and patient groups. Some of the latter such as the National Voices umbrella group of charities and voluntary organisations have been quick off the mark to condemn the memo and its implication that they can be bought. Others have been less so. I hope those in the latter camp do come out soon and distance themselves.  Yet I fear some patient groups are simply becoming more conservative by the day and, at this very moment in time, are spinning round in a quandry as to what they should do, evaluating all the possible things that could go wrong for them depending on their decision.  A bit like ‘Scoop’ in ‘Bob the Builder.’ What’s that about moral compass I hear you say?
  • I didn’t used to think this but I can feel myself moving to a position where I believe there should be a ban on charities receiving pharma funding.  Failing thatimum, they should be legally required to declare all monies received and the purpose. Otherwise some day a charity – and form suggests it’s likely to be the good but misguided rather than the rampantly criminal – is going to come a real cropper.
  • The best thing that the UK’s own pharma trade association, the ABPI, could do is openly say the memo is not something it subscribes too. Or somehow let it be known that its silence is a signal of utter disdain.
  • It is ironic that a sector which has pilloried the European Union for the last ten years for making research harder to do, should suddenly find solace in its tendency for delay and obfuscation.

But the really, really silly thing is that anyone could seriously take a position that transparency is bad for research and bad for patients.

As I update this in the evening it is only right and proper to point out that the associations referred to in this blog – EFPIA and PhRMA – have today issued their proposed principles for Clinical Trial Data Sharing.  Lots of coded language in there I think you will find….

Patient View Report: Pharma industry’s lack of transparency harming reputation with patients

Earlier this week Patient View published the results of its annual tracker of the pharmaceutical industry’s reputation among patient groups.

The latest study surveyed 600 patient groups (72% of them from Europe). As well as asking patient groups to rank 29 pharmaceutical companies by various indices (such as whether their practices were patient-centred) – Lundbeck came top – they were also invited to comment on the overall reputation of the sector.

Only 34% of the patient groups said that the industry’s reputation was ‘excellent’ or ‘good’ in 2012.  This is down from 42% in 2011.  40% said that it had actually declined and 48% cited the industry’s poor record for transparency as a reason.  Patient View’s report also notes the concerns expressed by patient groups over company practices with regard to the reporting of clinical trial.

Last Friday I spoke to a packed hall of researchers, clinicians and patients at the Berkshire Healthcare Research Collaboration.  The first question from the floor was from a patient and it was on this very subject of transparency.  Myself and other speakers were also pigeon-holed on the subject by other attendees at the close of the session.  The same has been true at many other meetings I have spoken at over the last few months.  Meanwhile the AllTrials petition numbers climb steadily past 8000.

I’ll let you draw your own conclusions from the above on whether you think this issue matters to patients or not.

 

Current Controlled Trials (CCT) appoints new advisory board

Current Controlled Trials (CCT), which aims ‘to increase the availability, and promote the exchange, of information
about ongoing randomised controlled trials worldwide,’ has appointed a new advisory board to help it in its work.  Other than yours truly, the Board includes Ben Goldacre and Paul Wicks (PatientsLikeMe) among its members, and is drawing on international expertise as well.

This is a really impressive operation with real ambitions to innovate and improve the information on trials that is available to professionals and the public.  So you might want to bookmark their blog or become a follower to stay up-to-date with new developments.

I feel rather honoured to have been asked to join and am very excited about getting down to work.

Behavioural matters: pharma could learn its way out of its ‘slump’ by working more closely with patients

I thought this short piece by David Shaywitz in US Forbes Magazine was terrific.

David examines three problems identified by the pharmaceutical industry as holding them back, and proposes solutions to each.  The first seems to follow on neatly from my blog on Saturday which looked at the venture philanthropy tactics being pursued by charities to fill the translational gap in medicines development.  He effectively suggests that this part of the landscape should be left to charities who have a better motivation to pursue it, and pursue it well.

In the second, he says that industry should re-focus its thinking and spending so that it’s not just investing in the science but putting effort into helping patients get more value from their medicines.  That means, as he says, more upstream involvement of patients in product development to ensure its outcome better reflects patient experience and the choices and behaviours they will make when managing their condition.

The third is about regulation and red tape…..  I quite liked his arguments about how the cautious behaviours of pharma are caused by an inflated perception of risk and obstacle.  I had the same thought in my car the other day.  It has those little beepers that tell you how close you are to things when reversing or parking.  I listen to those things far more than I should and my parking skills have taken a real nose-dive.  Anyone know how to turn them off?

Spirit of ad-venture shown by charities in funding drug research or a sign of desperate times?

From The Economist in New York, a short but interesting piece on the growing collaboration between charities, pharmaceutical and biotech companies in the US to bring new drugs to market.  More specifically it looks at the ‘venture philanthropy’ model being adopted by charities there to support clinical trials.  I’m not quite sure I’d characterise it as the ‘desparate’ lunge that the journal suggests, more an evolution in behaviour engendered by many factors; austerity and costs are just two.  It is also a quite deliberate and strategic move to foster innovation on their part.

We are seeing the same pattern emerge here in the UK.  In just the past month we have seen our two largest medical research charities both announce ‘venture philanthropy-like’ initiatives – Cancer Research UK and the Wellcome Trust - to boost drug development and fill the ‘translational gap’ as it is often termed.  ['Scope' have also announced something similar in the disability area.]

This is on top of what UK medical research charities are already doing to support clinical trials. If you want to understand more about venture philanthropy you might want to look at PhilanthropyUK’s website and this article in particular which talks about some of the areas in which venture philanthropy activity is growing – medical research being one of them.

The brute reality though is that I think this is a strategy really only viable for the larger charities who have the funds to invest.  But I would be interested to know whether the criteria they are adopting for investment decisions encompass the possibility of putting money into ideas being generated by other charities who do not have the scale to take them further?  I don’t see why not.  That could be a potentially important stimulant to greater collaboration between charities.  Or perhaps I have just got the wrong end of the stick, although surely it’s about investing in, rather than the provenance of, the idea.

Meanwhile PatientView has published the latest in its surveys of global patient group opinion about industry – this time it’s the turn of medical devices companies to come under the spotlight. In reputational terms, this sector within industry comes ahead of pharmaceuticals and biotechs in how well they are rated generally, but share the same dismal record in terms of ethical marketing.

This ahead of the annual conference of the Association of the British Pharmaceutical Industry (ABPI) in London later this week entitled ‘Can we afford innovation in medicine?’

European patient group directory has some way to go before showing full story on pharma funding

My good colleagues at Cancer52 (the rare cancers coalition) sent me this, the third edition of the Burson-Marsteller directory of patient groups.

On a purely practical level this tome is vital in helping to find your way round the various patient groups working on the European stage.

Note the introduction by the EU Health Commissioner, Robert Madelin, urging greater transparency by patient groups as regards their funding sources . The historic issue that has beset EU patient groups and colaitions is the degree of funding given and influence over their work that pharma has.

Clearly the authors are trying to move in the direction of greater transparency in the way that the listings are presented. Hopefully, by the fourth edition of the directory each entry will be better populated with this sort of information and in a way that might enable better analysis as well as comparisons across different health sectors.

Pfizer…and innovation emergencies

The news that Pfizer is to close its R&D facility in Sandwich in Kent has shaken us from our sleepy winter hollows.

I’ve been watching the reactions and comments come over the wires as I am sure you have.  This is clearly a company going through considerable transition as it tries to change with the times – see the Reuters round-up of their results today for a good insight.  And essentially its the sort of hard-headed business decision that US companies seem prone to take about their global operations when restructuring.

So, a comment on Pfizer’s view of the UK as a place to do science?  No.  As a place to do business?  Possibly. 

But perhaps we should treat it as though it were the former.  For, ultimately, the impact is the same.  The loss of a world-class R&D facility in the UK.  As others have said today, it shows we need to up our game in how the Government and those across research work with industry.

Meanwhile…and no link between the stories is intended…I’ve been absorbing today’s report by the European Commission (see also BBC News)  ‘ Innovation Union Scoreboard’  It looks at the research and innovation performance of the 27 member states of the European Union.  The basic story is that the UK is rated an ‘Innovation Follower’ (just outside the ‘Innovation Leader’ category) and is playing catch-up with those ahead of it at a slower rate than its peers in the ‘Follower’ group. 

If you look at the country profile for the UK on page 50 it says some complimentary things about the UK having an ‘open, attractive, research systems’ and the stats show we are above average in the number of non-EU doctorate students (relevant to the immigration debate surely) and public R&D expenditure.  On most of the remaining indicators the story is not so good.

The European Commission, whose way with words is to be eternally admired, says the report is evidence of an ‘Innovation Emergency.’  I am not sure what to do in an ‘Innovation Emergency’ are you?  Other than look for my patent box of course.

An evening of industry – how the pharma business model is changing

So it’s 10pm and I’m busy here putting the final touches to the AMRC/INVOLVE report of the workshop we held in November which drew together patient views on health research regulation. 

This was at the invitation of the Academy of Medical Sciences as part of their review of regulation and governance but – and all credit to them – we agreed that AMRC/INVOLVE will produce its own independent report of the event and I hope this will be out before Christmas.

Anyway, that’s just a bit of context for you.  While writing, I listened to an excellent edition of ‘In Business’ entitled ‘Bitter Pills’ looking at changes in the pharmaceutical industry with a focus on GSK.  Its worth a listen if you are interested in how the business model for pharma is changing fast.

When good medicine is the casualty of hype and ignorance

I have just returned from the Financial Times’ offices, where I was the guest for their regular science podcast hosted by Clive Cookson and Andrew Jack (it will appear here later today).  The theme of the discussion was ‘Selling Sickness.’  Andrew was reporting on a recent conference of the same name that took place last month in Holland.  The programme and presentations from the conference can be found here and they made interesting reading as I was prepping last night.

For those who don’t know, ‘Selling Sickness’ is a term used to describe the way in which the pharmaceutical industry and other companies are said to collude with medicine and science to create markets for new and existing products.  The claim is that they do this either by exaggerating the existence of a condition, fashioning a disease out of what one might call the ‘unbearable ordinariness of being,’ or playing on the anxieties of both the worried well and unwell.  Sometimes all three of course, as I am sure many of us have witnessed.

It is a contentious issue and the discussion this morning was interesting.  That companies should be able to hop, skip and jump through the established routes of defining disease in order to market and sell products should be a concern to us all.

From a patient and medical research charity perspective the worry is more specific.  It is that such antics lead the genuinely-ill down the wrong road with regard to treatment, while encouraging the genuinely-well to believe the worst and follow a path that means taking unnecessary risks with their health.  Only through a combination of greater openness, better regulation and also patient champions working with and within companies can we perhaps avoid the worst vestiges of this.

But it also says something about deep trends and changes in our culture and society.  One in which the expectation is set that we must all carry some vestige of ill-health or impending sickness if we are to be ‘complete,’ to be able to exercise choice in its fullest sense in a world increasingly run on fear and neurosis.

The irony of course is that, as individuals, we are not good at taking medicine which is right for us.  Also, that people are generally lacking in the support needed to alter their treatment regime if and when their condition changes.  The challenge is not so much medicines wastage but how to ensure more effective use of existing medicines.  That certainly seems to be the evidence published toay by the York Health Economics Consortium and The School of Pharmacy, UCL.  

This study shows that waste from primary care prescriptions amounts to about £300 million a year.  As the authors point out, in the context of an £8 billion drugs bill in the UK, that’s not bad. Indeed, the report is at pains to say that the NHS is quite robust at tackling waste i.e the stuff that is thrown away.  The real issue, it says, is ensuring more effective use of medicine:

‘The new research finds that up to £500 million of extra value could be generated in just five therapeutic areas (asthma, diabetes, raised blood pressure, vascular disease and the care of people with schizophrenia) if medicines were used in an optimal manner,’ it says.

Pharma Times is reporting today that Earl Howe (who is speaking at our AGM tomorrow) last week backed the idea of a new medicines service attached to pharmacies to help improve medicines adherence when he spoke at the Pharmaceutical Services Negotiating Committee annual dinner (I miss all the best gigs in town).

Moving swiftly on, the research by the York and London teams could not be more timely.  For the last six months I have been involved in a fascinating piece of work stemming from the Royal College of Physicians report last year: ‘Innovating for health: Patients, physicians, the pharmaceutical industry and the NHS.’   Following its report, the College established a ‘Medicines Forum’ which was charged with looking at how the report’s recommendations could be taken forward.  This was to be done with the help of some sub-groups focusing on specific streams of work.

I am on what is called the patient sub-group – chaired by Harry Cayton and composed of patient representatives, pharmacists, GPs, regulators and others including Professor David Taylor from the School of Pharmacy at UCL.  We have chosen to focus on two issues: medicines concordance and; public involvement in research.  We are nearing the end of a series of enrgossing evidence sessions with a wide variety of people and organisations – from Boots the Chemist to the Royal College of Pharmacists, from the Science Media Centre to some of my members such as the Motor Neurone Disease (MND) Association – and will report to the College shortly ahead of a conference it is doing in February.

I feel that we are arriving at a good diagnosis of why people don’t take their medicines (it is as much to do with the quality of interaction with a health professional as with the quality of information).  We are now turning our minds to some solutions and recommendations.  I am sure that the need for more investigation and research into this issue will be one of them, and I hope that my members will take up the challenge as I know some already have.

But it has also highlighted for me that,  in the endless discussions about translational gaps in getting science from the bench to the bedside, we have spent far too little energy in the UK exploring how to ensure that it gets from the bedside to the, well, patient’s inside?  A simple process one would have thought.  But many influences can determine whether it happens fully, partially or not at all; I have already mentioned just two.  In the drive to create and develop medicines that meet real need, we must not forget the need to pay greater attention to this final, translational gap. 

That’s a long way from selling sickness I know.  But much more in the public interest, wouldn’t you say?

Time to open up about industry

Every so often a story and resulting furore crops up in the media about charities, patient groups and their closeneness to industry and, in particular, pharmaceutical companies.   Journalists and the public will quite rightly ask: is it in the public interest? 

I can well remember my first encounter with big pharma in my early days of working for a medical research charity.  At that time, the company concerned was the only one with a treatment that looked likely to be approved for use in the UK for this particular disease (it did not get approval in the end as it happens).  Part of its strategy was clearly to enlist our support in the hope that we would campaign on their behalf for this drug to be made available. 

To say they were cumbersome, aggressive and patronising in how they went about this would be an understatement.  They would have called it relationship-building no doubt.  I would have called it a mild case of bullying.  Its effect was counterproductive not least in making me, us, extremely defensive when the more responsible companies with better products and a more sophisticated attitude to partnership came round.  But on the other hand it also made us define exactly what we wanted these partnerships to look like, in whose interests and in what manner we wanted them conducted. It led to the development of a clear policy that is now publicly available on the charity’s website.

For some time I also worked in mental health and was dismayed about the way that industry acted and behaved.  No wonder industry has had such a large moutain to climb in recent years.

But that was then and this is now. Last week AMRC held a ‘think-tank’ with representatives from both industry and charities which focused not only on some excellent examples of how the relationship has changed but also on what needs to happen next to continue build public confidence – from ending the under-reporting of negative results from industry-backed research, to steps to improve transparency and ways of involving patients in every aspect of how research is taken forward.

Perhaps what lies at the root of the ongoing concern is a fundamental lack of public understanding not only about the cost of research and the development of new treatments – impossible to sustain without industry involvement – but also the collaborative effort that is required to bring drugs and therapies to the bedside; a collaboration that must and does involve Government, academia, funders and industry all along the way. You might also be interested in a report recently put out by the Alzheimer’s Research Trust which showed how industry money will often focus on developing new discoveries made possible in the first instance by charity and public investment.

But charities and industry also have a shared responsibility to be more open in explaining to their patient groups and the wider public why they are working together, with what aim and how this happens. They public may be surprised to learn for instance, that the interaction between the two is less and less about sponsorship, marketing or education, and more about identifying the needs of patients and identifying possible opportunities for science and drug development. That is surely a good thing and entirely in the public interest.

Without a doubt there continue to be some ill-conceived if not downright dubious practices out there that both sectors need to police and change for the better – practices that will continue to undermine more responsible corporate behaviour. Things like ‘astroturfing‘ – the term used to describe the way in which some companies establish so-called patient groups which are nothing more than fronts for an industry campaign.

But on the other hand I would take issue with the claim of Sir Michael Rawlins from NICE that the public should be concerned when industry and charities join forces to press their case for a drug to be approved.  Methinks it is a case of the regulator feeling the heat and protesting too much.

So, what next? In the coming months the Association of the British Pharmaceutical Industry (ABPI) is likely to push for ever greater openness by its members about this relationship in the next iteration of its Code of Practice. I believe that charities should match this with a similar commitment to transparency as AMRC set out in ‘Essential Partnership: principles and guidelines for working with industry’ - from having publicly available policies on how they work with pharma to reporting who they work with in their annual report and accounts.  Like this by BHF…or this by the MS Society.

In all this debate it would seem that the independence of the charity sector is key to reassuring the public.  Too often I think we expect people to take this for granted.  But in these more cynical times, it is only through greater transparency that commentators, patients and the public will see why working with industry is in the public interest and the efforts we go to to maintain this independence.

Charities and the media

Today I hotfooted it (literally in the 30c+ heat!) to the World Conference for Science Journalists (WCSJ) taking place at Central Hall in London.  I was taking part in a debate on the question: ‘Is the growing influence of PR on science journalism in the public interest?’

The other speakers included Ben Goldacre from the Guardian, Andrew Jack from the FT and John Clare from  Lions Den Communications – a PR company.  It was a good debate raising some interesting issues for not just my members but all medical research and health charities.  On the way back a few questions struck me:

Do charities train and support their press team well enough to handle science stories, filter the spurious from the evidence-based, and fight their corner with colleagues who are anxious to raise the profile over and above anything else?

As charities increasingly become direct-to-patient providers of information and comment on science and health stories are they doing enough to also quality control what they and their colleagues are saying?  And should they be more proactive in dishing the bad stuff rather than trotting out the perennial ‘more research is needed.’

How close is ‘too close’ when charities work with industry?  What should charities be expected to report in terms of links, funding and public benefit derived from it?

As it says on the exam paper: Discuss?

Today I took the line that the PR industry and its people  (which includes those doing PR for charities) are too easy a target for those who criticise what is in fact a system-wide problem in how we feed the beast that is today’s mass communications industry.

But, above all, that patients are actually better at discerning the rubbish from the sensible if given the right tools and the opportunity to engage with health professionals.  A media story about a new treatment is often their starting point not their end point.

That good science – and the organisations that stand for it – do not put nearly enough money into communications and PR and are ten years behind the PR industry in their thinking about public engagement with the modern consumer?

That charities should work with industry.  It is no bad thing.  But the relationship needs to be open and transparent and we all have a duty to police and get rid of ‘Trojan Horse’ patient lobbies which are in fact industry mouthpieces.

As I say, discuss?  It is an interesting topic and the debate will likely run and run.

In the meantime, watch out on our website for details of our workshop next year for press officers working for medical research charities entitled: Communications: is it a science or an art?

And if you can’t wait that long, a reminder of AMRC’s guidelines on working with industry ‘An Essential Partnership.’

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