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The tough return

Liz Shanahan berates recent research as 'manipulative, irresponsible and insulting'

Anyone who read the Branding the Cure report from Consumers International might well have had serious concerns about the behaviour of one of the world's most significant industries: The pharmaceutical sector.

On closer examination, however, anyone with any understanding of the regulations around this industry could not help but be flabbergasted by the extraordinarily poor quality of the report and its sweeping generalisations.

Branding the Cure appears to be the first in a series by a group which seems to have an anti-industry bias. I am not being unfair to them in my assessment. Their view of our industry is extremely unfavourable, their negativity barely veiled.

The report opens with a question: `are the grand claims of responsible behaviour asserted by the pharmaceutical giants genuine, or another disappointing show of corporate savvy in masking ethically questionable behaviour?'

This, already charged, question and the free flow of hostile, sarcastic superlatives should have given it away from the outset. It is regrettable because those behind the document ask some legitimate questions; however, it is my belief that they were so focused on achieving the results they were looking for that they never managed to unfurl some of the real issues at stake for consumers in Europe.

Research murk
Their case may have had more credence for me if the quality of the process had been robust. In the pharma industry, we have to be very careful about the quality of research we undertake. Therefore, I do not think it is unreasonable to demand that if an organisation attacks an industry unrelentingly, their research should be robust and beyond criticism.

I am also no fan of research being manipulated to give you the answer you were looking for. The core principles of research methodology - ie, those which can be fully substantiated - were, seemingly, conveniently ignored for the purposes of this report.

The baseline data supporting such claims is also key. I know how easy it can be to cherry-pick the data from the base, and thus I politely requested several copies of Consumer International's own technical reports, as I wished to interrogate the data more fully.

Yet - and notably for a group calling for transparency in the pharma industry - it was not lost on me that their own transparency is questionable; my request was refused by their London office. Hence, some of my comments are conjecture, as I was able to gain only a limited understanding of their approach, methodology or real results. Indeed, their approach and choice of research subjects and countries are not fully explained, making it very difficult to truly assess their perspective.

Consumers International claims to have conducted research in 20 pharma firms based in Europe, and examined a handful of European countries in detail.

It could be argued that, with the exception of Denmark, their sample comprising Czech Republic, Finland, Greece, Hungary, Portugal and Slovenia was hardly representative of European countries with active pharmaceutical industry R&D. Neither do they function as large marketing bases for the pharmaceutical industry. It is clear that many of the companies approached did not engage with the group, further diminishing the quality of their baseline research.

A loaded gun?
In the public relations business, we always check out the group which is asking you to participate in a research project or an interview. The majority of journalists are unbiased in their approach, but occasionally you come across one which will do pretty much whatever it takes to get the slant they are looking for.

If they have decided, before they start their research, that the industry is `masking ethically questionable behaviour', it is unlikely, no matter how many examples of ethically good, honest and consumer-beneficial behaviour you highlight, that they will acknowledge it in the final edit.

If that was the tone of their approach to individual companies, it is unsurprising that they were reluctant to respond to them, as noted in their executive summary.

In addition, I suspect that their research questionnaire, if it was issued to the local affiliate companies, had hardly made its way to those at the EU headquarters who could answer the questions on R&D spend and other quite detailed issues regarding corporate policy prior to the six week deadline. Even then, I would suspect that many of those were justifiably cautious about participating in a research project conducted by journalists*.

If there was an attempt to engage the industry's bodies to gain their assistance and buy-in to the process, it is not evident. I think most companies, if they felt they would be judged fairly would be more than happy to participate. The opposite, obviously applies when you feel that fairness and balance have been removed from the equation.

Marketing codes
It is also disappointing that Consumers International's (CI) report writers appear to understand very little about healthcare regulation in Europe - or perhaps they do and simply chose to ignore it. They acknowledge that drug promotion direct to consumers in Europe is illegal, yet many of their comments and conclusions relate to consumer communications.

They focus on what they believe is the pharmaceutical industry's apparent lack of adherence to promotional codes of practice, and allude, further still, that many companies adhere to none.

Of the 20 companies cited to have been targeted as part of CI's research, most were from the top-20 globally, with six notable exceptions: Almirall Prodesfarma, Lundbeck, Menarini, Novo Nordisk, Nycomed and Orion. All 20, bar Nycomed, are in the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and/or the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Throughout the report, they cite the lack of individual company codes of practice, or lack of specific policies on marketing practice. They state confidently that most companies fail to hold specific policies in relation to representative behaviour, direct-to-consumer communications, clearance procedures for promotional materials and activities, and, most extraordinarily, regarding whether sales representatives can recommend off label use.

Either CI was aware of the IFPMA, EFPIA and the individual laws, regulations and codes of practice available for each country it studied (note - as I said earlier, not a true representative European sample, but none the less, each one, Czech Republic, Denmark, Finland, Greece, Hungary, Portugal and Slovenia, all have locally developed codes of practice) and chose to ignore the facts, or failed to understand the rules of membership of these various groups.

It has been a requirement of IFPMA membership since 1988 that member associations accept the conditions of the IFPMA Code, which, in its most recent revision, has been strengthened further to stipulate that member companies, subject to local laws and regulations, adopt codes that meet local requirements but are consistent with, and as comprehensive as, the IFPMA Code.

This situation is similar to the EFPIA Code, last revised in November 2004, which stipulates that the spirit, as well as the letter of the provisions of the Code must be complied with.

Companies should, for example, apply consistent standards to their relationships with healthcare professionals, particularly with respect to gifts and hospitality. EFPIA also encourages compliance with the letter and spirit of the provisions of the IFPMA Code of Pharmaceutical Marketing Practices where applicable.

CI does not directly accuse the various pharma companies in the report of not complying with the codes, it simply states that they did not confirm their compliance to the researchers.

The report is thus written in such a way as to imply that the targeted companies do not have proper codes of practice to which they comply. CI chose to ignore the fact that most companies, by their very membership of the various industry bodies, publicly declare their adherence. In addition, CI reports well-documented, publicly-available ABPI Code of Practice breaches as examples of the industry flouting its codes. I take the opposing view and believe it shows how well self-regulation really works.

The report also gives the impression that such breaches are hidden from consumers, whereas the opposite is true.

There are other angles to the report, including a call on the industry to publish its promotional spend in more detail. You can read it in more detail at http://www.consumersinternational.org/.

In greatest need
Branding the Cure is actually the second part of what is a series of reports based on the same research, the first of which was issued to the World Health Organisation's World Health Assembly in May.

It demanded an end to the pharmaceutical industry's 'domination' of R&D, concluding that doctors were 'corrupted' by their relationship with the industry and that their involvements with each other need to be more transparent.

Also expressed was particular concern about the R&D needs of consumers who are poor and live in developing countries. This would disappoint Dr Mary Moran and her team at the London School of Economics who, last year, produced a thoughtful, well-researched and robust review of current R&D partnerships between pharma and relevant third parties on current projects for this venerable group in the developing world.

The New Landscape Of Neglected Disease Drug Development noted that more than 60 drug development projects were in progress for neglected diseases, including two new drugs at registration stage and 18 in clinical trials, of which half are already at phase III.

Assuming there was sufficient funding, at standard attrition rates this scenario would be expected to deliver eight to nine new medicines within the next five years, even if no further projects were commenced after the end of 2004. Multinational drug companies conduct approximately half of current neglected disease drug development activity (see the whole report at http://www.lse.ac.uk).

I will certainly be sending a copy of The New Landscape Of Neglected Disease Drug Development to the team at Consumers International.

Responsibility?
CI hangs its June 2006 report on the banner of corporate social responsibility, which it defines as 'beyond profit making - protecting the environment, workers, being ethical in business operations and being involved in local communities'.

This is a legitimate concern for all consumers. I do not believe the industry I work in is packed to the gills with unethical individuals who will gladly sacrifice a few lives for a few pounds. On the contrary, the researchers, professionals and marketers I have met and worked with are motivated by their great belief in the benefits their medicines can bring.

Drug safety is taken seriously with even a hint of a problem examined in detail. I think it is insulting and irresponsible for this report to have tarnished the great work so many of us within this industry undertake, and given consumers such a misleading impression throughout Europe.

In my opinion, one of the greatest issues for consumers is actually the conspicuous lack of information on the diseases they suffer and the treatments, medicinal or otherwise, that are available to help them.The European Commission's insistence at keeping consumers ignorant of medical information, and individual countries' concerns that informed patients might push up health bills are some of the biggest issues facing consumers in Europe.

If you suffer from conditions such as hypertension or chronic obstructive pulmonary disease, you will struggle to find information on your condition and the possible treatments for it.

This state of affairs was acknowledged recently by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which now actively encourages UK-based pharma companies to publish information on their products online.

Cost-effectiveness
I find it, frankly, annoying and deliberately manipulative of this group to have written and reported on their 'consultations' in the manner in which they have.

As we in pharma are all acutely aware, we could never quote such sweeping generalisations as `drug promotion highlights an emerging crisis of legitimacy for the concept of CSR' and `shocking lack of transparency' based on the flimsy evidence supplied by this poorly constructed report.

My annoyance is doubled by the fact that the hard earned tax money of consumers like myself, through the European Union, was used to fund this appalling rubbish.

Shame on the European Commission for endorsing such shoddy practices and allowing itself to be associated with something so clichÈd and poorly constructed. How it was felt that this approach was innovative is beyond me.

Finally, I think as an industry we need to start developing more robust responses to this type of shoddy research. All too often we dismiss it because we feel it is so ludicrous or, in many cases, unfairly based. Yet, unfortunately, our silence adds a veil of legitimacy to these types of report.

The conclusions of this group are a list of recommendations to pharmaceutical companies, the European Union (one of CI's funders), as well as individual governments and regulatory bodies.

One key recommendation is to develop and enforce sanctions for companies found to consistently breach guidelines (and regulations).

Inadvertent code breaches do happen, as we all know, and legitimate businesses could find themselves at great risk if CI's recommendation of revoking business licences was to be adopted at a European level.

The Author
Liz Shanahan is the managing director of SantÈ Communications, an independent healthcare specialist communications consultancy

2nd September 2008

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