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First class relationships

Published on 06/11/06 at 03:37pm

Pharma goes 'no frillls'

Provocative headlines drawing attention to inappropriate behaviour and misconduct in the medical and pharmaceutical professions have been rife over the last few years, but sensational stories taken out of context have often distorted the reality of regulation in the UK pharma industry.

The Association of British Pharmaceutical Industry (ABPI) and the General Medical Council (GMC) have responded to such stories and allegations about their members, but just what effect have their responses had? And is it enough?

Disband the GMC, demands a former GMC president, and he continues to seek a fresh start with tighter regulation of doctors in the field of research when it comes to reporting and giving opinions on drug treatments. Meanwhile, a release from the Royal Society of Medicine proclaims the pharmaceutical industry cannot be trusted to deal with biased reporting of clinical trials without stricter regulation.

In December 2005, MPs held a House of Commons debate about the influence of the pharmaceutical industry on doctors, which was itself inspired by concerns raised by a Health Select Committee report on the industry.

Calling dozens of witnesses and taking months to complete, the Health Select hearings enthralled the consumer media and taught the general public acronyms such as KOLs (key opinion leaders) and TLs (thought leaders). The consumer press seemed to conclude that labelling doctors this way was proof enough of the industry's ingrained misconduct.

This growing chorus of disapproval led the ABPI to issue a new code of practice in January 2006, which aimed to tighten up the letter of the law, while also making it clear that it would be policed much more rigorously than before, with more serious consequences for any offenders.

Among its changes, the updated code outlines more precisely how activities that could be seen as inducements are to be used. These range from gifts and educational aids to travel, conferences and meetings where leading doctors and researchers (whom we call KOLs) present their opinions, practices and research.

One key change also relates to the area covered by the code of practice as it now includes non-UK meetings in the UK and any British doctor or company conducting activities in another country. Most companies have immediately taken up the code and, in fact, the number of complaints has not increased due to these changes.

Many companies have implemented their own internal regulations which go far beyond the demands of the code. For example, the ABPI code requires doctors attending conferences to be provided with economy class travel only, but some companies have extended this to conference speakers.

The view taken by the ABPI seems to have been that speakers may reasonably be expected to need to arrive refreshed, but some UK pharma companies want to be seen to be above all accusations of laying on the all expenses paid junket, so beloved of newspaper exposes.

New rules and regulations

Furthermore, the General Medical Council, the medical professions own self-regulating body, is also now examining its rules, and is expected to issue new guidelines imminently. These rules are likely to strengthen regulations around accepting gifts or hospitality in exchange for prescribing or inappropriate promotion, and may encourage doctors to report their colleagues to the GMC if they infringe on the regulations.

The GMC is also considering expanding its register of interests that already covers its council, committee and executive members, requiring them to declare outside affiliations and memberships.  

The current guidance also states that a doctor must not ask for or accept any gift which may affect. or be seen to affect, their judgement in the treatment of patients. If a doctor is disciplined by the GMC, they may be suspended, fined or even struck off the register in the UK.

Although no complaints about the accepting of hospitality or gifts have been officially received by the GMC against a doctor in the past five years, there are frequent complaints and disciplinary actions against doctors who inappropriately conduct or report study results and trials - although none has been found to have done so at the request of a pharmaceutical company or CRO (clinical research organisation).

One of the stimuli for this change was the clear disparity between punishments for the industry and for doctors. In one high profile case, a UK pharmaceutical company was suspended from the ABPI for inappropriate hospitality with doctors, yet none of the doctors involved faced any disciplinary action whatsoever for accepting the hospitality.   

Have these efforts gone far enough? Yes, say those close to the industry and within it. Many MPs seem also to be reassured  the House of Commons debate concluded that attending sponsored educational events or accepting materials does not mean that the doctors, speakers or pharmaceutical companies are acting inappropriately.

Despite these positive signs, we must all look ahead to more criticism from those who only see headlines and watch movies. Coming soon to a cinema near you is Michael Moore's highly anticipated film, Sicko, purportedly an expose of the excesses of the pharma industry and other profit-making companies within the US healthcare system.

Who knows if this provocative film-maker has noticed the tightening of the UK and EU regulations about working with doctors, and what, if anything, he makes of them?

That said, always remember that the work we do creating new treatments is important, and communication about these innovations and their correct use is absolutely vital. So, it is our professional duty to work responsibly and with a full understanding of the current regulation and its spirit.

Cressida Robson head of practice at Healthcare Euro RSCG Biss Lancaster. Clients for key opinion leader work include: Bayer, Arla foods, Kimberly-Clark and Roche Diagnostics


A pan-European standard

New codes of conduct for the pharmaceutical industry have been launched in countries across the European Union over the past two years, a move co-ordinated by EFPIA, the industry's pan-European organisation.

EFPIA's code of practice has been in place since 1992, but its uptake has not been closely enforced.

Spurred on by changes in EU law which emerged in 2004, and by growing criticism of the industry, EFPIA issued an updated code of practice in November that year, with stricter controls on marketing and relationships with healthcare professionals.

The organisation instructed its members to implement the code in their territory as quickly as possible, but allowed just over 12 months for adoption across the EU

The EFPIA code sets out the minimum standards which must apply, and members have been encouraged to tailor their codes to national conditions and add extra provisions beyond the EFPIA template.

EFPIA members met earlier this year to discuss progress made on codes across Europe, and the first EFPIA code report was submitted to the board in September, with its conclusions expected to be made public shortly.

Early indications are that EFPIA will conclude companies have shown new determination to raise standards in respect to events, hospitality, entertainment and gifts, but concerns persist about some novel marketing techniques, according to a recent EFPIA newsletter. It says these include border-line disease awareness campaigns, inadequate promotional material and grey zones between clinical trials and post-marketing studies.

Overall, concerns about unsubstantiated claims in the promotion of products were considered the most important issue, with the EFPIA Code Committee keen to revise the code further and clear up any remaining ambiguities. It added that general management still needs to intensify communication with field force managers and, in turn, individual medical representatives, their sheer numbers and volume of contacts meaning they are involved in many of the complaints.

The Code Committee concluded it was also important to ensure there was a level playing field across the whole of Europe, and acknowledged that implementation of the code is still not consistent throughout the national associations.


Disconnected from the frontline

Vast amounts of time and money are spent on KOLs and guideline committees to allow them to advise on brand positioning, new data and the relationship of the next medical breakthrough to current protocols.

One frustration for marketeers, however, is that GPs, the bedrock of most brand plans, are too busy to change their prescribing every time a guideline changes or a protocol intervention point is amended. After all, whereas specialists in, for example, asthma, have one, maybe two guidelines to consider, a GP might have 50 - no surprise, therefore, that they hold on to what they already know.

There is, however, a common language or metaphor used by the NSFs, medical association treatment guidelines, disease area diagnosis protocols and, most importantly, the KOLs and the coalface GPs.

Disease models are metaphors which doctors carry around in their heads; it allows them to consistently diagnose, treat and monitor all their patients for example, the cardiovascular system can be likened to central heating, so solutions are mechanical/engineering based.   KOL disease models differ because they continually develop new variants to explain new data, which explains the communication issue; they want to talk about their model, not the current GP model.

Good planning, however, will align your positioning with evolving disease models, via continuity of thinking and communications, to join your brand with the KOLs and the coalface, therefore.

This can be done by:

* understanding the relevant disease model: it's easier to understand how treatments are chosen, because they are reproducible across target audiences and geographies, and are consistent in allowing health professionals to talk to one another coherently, thus removing the gap;

* providing a way of opening up debate and opinion: brand managers can align their brands to clinical thinking and drive KOL consensus without losing the attention of the coalface;

* focusing on one particular aspect of the disease model: you can potentially open new, uncontested markets, while still fitting with how prescribers think;

* measuring success: the level of support for individual solutions is reflected in the commitment to a particular disease model, not just a validation of guidelines or protocols - a disease model consensus will, by its very nature, remove the gap.

So, instead of consulting with KOLs about incremental efficacy or compliance benefits, the better strategy may be to define the disease model, gain consensus, align your brand with the model and, finally, invest in communicating with prescribers, not talking at them.

Paul Keirnan, director of PR company Sudler & Hennessey. Clients for key opinion leader work include: Wyeth, BMS, ALK Abello, Colgate Palmolive, Numico


Identifying rising stars

How do we identify and develop our relationships with the younger generation key opinion leaders - i.e. the rising stars?

The mobilisation of KOLs in medical education programmes is established practice in pharma and many agencies profess to have expertise in this area. The challenge is to capitalise on new and existing relationships between pharma companies and KOLs in an innovative way, in a crowded market where the same opinion leaders are often working with competitors. This may be the challenge, but the requirement is to achieve this within the spirit of our code of practice.

In both new and established markets, the ongoing identification and development of new opinion leaders is key to ensuring refreshment and consolidation of the available pool of speakers, authors and advocates on a regional, national and international basis. To appeal to all audiences, a broad base of KOLs is required for elements of an integrated marketing programme and the value of KOL endorsement is inexorably linked to the integrity of the advocate themselves.

Valuable relationships are essentially between people, not companies, so consistency of personal attention is vital, particularly when marketing teams change, as they inevitably do. Agencies can be fundamental allies here and in introducing new opinion leaders to clients when they have experience in a range of therapy areas.  

Once potential new KOLs are identified, the goal is to attract them through programmes of value to all concerned, ideally ahead of competitors. A recent project of ours, which was shortlisted for a communique award, achieved this by presenting a novel and bravely critical perspective on the relationship between the pharma company and the clinician to an audience of SpRs and new consultants. The programme provided key skills for their future career development such as presentation, facilitation and expert witness training, thus starting a potentially career-long relationship with the KOLs of the future.

In summary, the current environment of high scrutiny on pharma company activities emphasises our responsibility to maintain the integrity of the opinion leader, pharma company and agency. Consequently, expertise in fresh approaches to KOL development strategies will always be required in our industry.

Annabelle Hunt, associate divisional director and Holly Cotterell, senior account manager, Huntsworth Health, Medical Communications Division. Clients for key opinion leader work include: Sanofi-Aventis, Pfizer, Norgine, UCB, Novartis, Abbott, Servier


The sudden threat of legal action

The issue of pharmaceutical companies promoting off-label uses for their products took an astonishing turn recently when a US clinician was arrested and charged for promoting the use of a product in an off-label indication.

Intriguingly, the issue only became public in July, despite the doctor being arrested in March. Dr Peter Gleason, a Maryland psychiatrist, was equally surprised. He told the New York Times he thought his arrest must be a practical joke: I said, "Well, this is a gag", They said: "No, it isn't".

It is clear that the US prosecutors believe Dr Gleason went too far. Dr Gleason admitted that he had spoken at hundreds of meetings and been paid fees of more than $1 million by the pharmaceutical company behind the medicine involved. The allegation against Dr. Gleason is that he advised doctors that the medicine, licensed for use in  narcolepsy, could be prescribed for depression and pain relief.

The prosecutors believed this meant he conspired with the drug's manufacturer to recommend it for use off licence. So much so, in their press release announcing the indictment, an assistant FBI director compared Dr. Gleason to a carnival snake-oil salesman.

Although Dr Gleason has had support from colleagues in the US who believe he has been unfairly targeted, the case is not quite so straightforward.

The drug involved was Xyrem, which is no ordinary medicine. It is a licensed version of gamma hydroxybutyrate, or GHB, which is a drug of abuse, often known as the date rape drug and an overdose can kill. Xyrem is listed as a Schedule 1, federally controlled substance, in the same category as heroin, and its distribution is tightly monitored.

Dr. Gleason claims he was interested in Xyrem long before the drug was officially approved, believing it to be more effective than licensed medicines for insomnia and depression, which he claimed were either addictive or had serious side effects. "I immediately just started prescribing this stuff in 2002," he said

An opinion too far

His enthusiasm for Xyrem may, however, have gone too far. In one meeting cited in the federal indictment, Dr. Gleason told his audience that table salt is more dangerous than Xyrem.

In addition, it seems that Dr Gleeson may be part of a larger investigation into the pharmaceutical company involved. According to Dr. Gleason: They said, "Who in this company roped you into this conspiracy?"  

Dr. Gleason's account is at least partly supported by a letter on 13 March from Geoffrey Kaiser, an assistant US attorney to Lois Bloom, the federal magistrate judge overseeing the case.

In the letter, Mr. Kaiser asks that the case be kept quiet because Mr. Gleason may be willing to co-operate with this office in its broader investigation.

The issue is a cause for concern within the pharmaceutical sector and within the medical education companies, which are often involved in assisting pharma companies to run meetings that have clinicians such as Dr Gleason speaking.

Whether or not Dr Gleason overstepped the mark or not is yet to be resolved. What should concern our industry, though, is that although the various codes of practice allow for the legitimate exchange of new clinical data and the sharing of scientific advances, this case could conceivably set a precedent for disallowing this type of legitimate debate and, therefore, potentially stifling clinical debate

Liz Shanahan is managing director of Sant Communications and chairman of GLOBALHealthPR - the medical education, PR and public affairs specialists. Clients for key opinion leader work include: Sanofi-Aventis, BMS, Schering.


Overcoming mistrust of pharma's objectives

When it comes to talking about trust between  the industry and key opinion leaders, it is all too tempting to trot out the old gags about brown envelopes stuffed with cash.

But with the media ever more viciously on the case of an industry whose profile has taken an enormous battering in the last year, should we be joking at all?

Well, no. All too often, pharma marketeers try to gloss over the need for transparency and trust in their dealings with KOLs and this is a recipe for disaster.

KOLs are often understandably wary about close collaboration with the industry. So how do we ensure that any misperceptions do not become self-fulfilling? For the industry, there is everything to gain from collaboration as, at every stage of the development process, external KOL input is vital for strategic communication planning.

"Trust, in my view, is based on regular and open two-way communication. For many KOLs, this trust is there and always has been," said David Roberts, European marketing director at Takeda Europe.

Perhaps because the industry tends to change people and job functions so much, this strong relationship continuity sometimes fails and information flow becomes reduced.

So how do we establish trust? First, we must define the ground rules. The key to good collaboration is a shared agenda, and at its most basic, the aim has to be to improve patient outcomes.

But for the industry, this nearly always involves the drug. There is no point in being coy about commercial objectives - be upfront about the level of promotional input you require. Do not imply that you are simply seeking a KOLs input for disease awareness unless this really is the case.

Second, do not oversell your product. Be objective about it - disclose any key issues to your KOLs and agree appropriate responses.

You must also show that working with the industry is legitimate. KOLs need to retain and demonstrate their independence and do not wish to be seen to be in the pocket of any company. In any case, this would devalue the message they deliver.

Physicians and academics have to adhere to codes of practice within their country, which may change frequently. This may cover honoraria, travel, hotel accommodation,  expense allowances, and programme content, including time allocated to educational rather than social activities.

It's important to be clear about your plan of action -  just what are you asking the KOL to do? Other positive steps can include participating in clinical research; joining an advisory board and deciding if this will include advising on marketing messages as well as reviewing the clinical trial programme; speaking at congresses or meetings; authoring, or co-authoring, journal articles; and speaking to the media.  You must be clear about what you will provide, and once you have agreed partner activities with your KOLs, put the reimbursement terms in writing, bearing in mind that this may be non-financial, such as giving technical assistance with slide development, literature requests, or editorial support, or making financial provisions, such as the sponsorship of meetings, or giving an honorarium  for the time spent by KOLs when attending meetings.

Kate Hawker is managing director of The Remedy, Fleishman-Hillard London


Return on investment

Competition for experienced and influential physicians is heating up and the key strategic activity for pharmaceutical companies seeking KOLs to assist in researching, launching, and marketing new drugs is becoming increasingly more difficult as a result.

KOLs offer valuable insights into disease states and patient treatment regimens, in addition to new product exposure through medical literature and their professional circles.

Pharma companies which excel at building relationships with opinion-leading physicians can open doors that enable them to disseminate new product information and clinical trial results to the medical community through trusted sources.

A carefully crafted strategy and timely execution of a KOL management programme will have an enormous impact upon building and developing the KOL relationships needed to build the scientific credibility of a brand.  

Many pharmaceutical companies now use these programmes as their primary channel to engage medical opinion leaders, but to deliver maximum value, these programmes must be managed as integrated processes that successfully develop and expand relationships.  

Measuring the results of KOL programme efforts are required to identify opportunities for continuous improvement and they should be aligned with overall brand strategy and customer value drivers to fully maximise market opportunities.

Pharmaceutical companies acknowledge the high impact KOL management programmes have on pre-launch and post-launch marketing and have increased staffing resources over the last decade to manage more OLs in more therapeutic areas.

Stephen Dunn, commercial director at Darwin Grey, part of the Grey Healthcare Group.Clients with respect to KOL management and advocacy development include: Novartis, Roche and J&J.

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