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Key expert-pharma relations: a new era

Published on 20/10/08 at 12:02pm

The relationship between doctors and the pharmaceutical industry has attracted considerable criticism in the past five years. Scepticism has risen, along with concerns about doctors being vulnerable to manipulation by pharma.

Although not a new debate, it is once which is attracting more and more attention. A recent article by Ray Moynihan in the British Medical Journal raised the question: Are key experts (KEs) drug representatives in disguise? Clearly the challenges surrounding the key expert-pharma relationship need to be addressed.

The debate has reached a critical point which is prompting a shift in how, why, where and when KEs and pharma interact. These issues were recently discussed by KEs from both the pharmaceutical and the medical communities at the inaugural 'Key Opinion Leaders: Understanding Physician-Pharmaceutical Industry Relationships' conference in London last month.

Joint responsibility for the relationship is required. Industry is much more likely to be penalised for inappropriate interactions, but it is not acceptable that it should solely bear that responsibility - KEs also need to clarify their relationship with industry and adopt best practice.

This shift in attitude will see more 'authentic' relationships evolving in which both sides work together to realise their clinical and commercial aspirations. Maintaining transparency within the relationship is crucial to prove that priority for both parties is improving things for patients.

This article examines the relationship between key experts and pharma, and shows how this more unified approach is now vital for improving its image in the future.

Under scrutiny

Ultimately, key expert-pharma relationships should not be about 'influencing' KEs, but encouraging positive collaboration between all types and levels of healthcare expert.

The nature and consequences of KE-pharma relationships are regularly debated in both specialist and public media and constitute one of the most contentious issues in healthcare. Impassioned views range from KEs who pledge to have no interaction with pharma at all, through to others who feel that collaboration is essential to underpin scientific advances.

Those opposed to pharma's influence on KEs feel that financial gains from such relationships may influence prescribing habits. Others feel that ethical arguments are hindering the production of new or improved treatments that would benefit patients.

The key questions are:

* What value do KE-pharma interactions have in terms of benefiting medical science and patient care?

* What developments are needed for KE-pharma relationship management to evolve?

* What improvements and new methodologies will underpin future successful relationships?

* What is pharma currently doing to improve transparency?

Stringent guidelines concerning KE-pharma relationships have recently been introduced across Europe, reflecting the more extreme situations in the US and Australia. In the US, the 'Sunshine Law', passed last year by the US Senate, requires pharma companies to report the fees they pay to physicians, while Medicines Australia now publish six-monthly reports containing details of medical education events sponsored or held by pharma.

Currently industry is heavily criticised for the amount of money it spends on developing relationships with KEs, while doctors have to make multiple conflict-of-interest statements concerning who they work with. But little, if any, information is communicated about the medical benefits of such collaborations.

Pharma has, on occasion, approached these relationships with a 'command and control' mentality that is unacceptable to the medical profession and to the public.

To restore faith, pharma needs to engage different types and levels of medical and healthcare expert in a more aligned collaboration where all stakeholders accept responsibility for their interactions.

Aligning aspirations

Pharma and KEs recognise that responsible leadership is no longer about influencing opinion, but working together to ensure that pharmaceutical products are safe, effective and benefit patients.

Both pharma and KEs need to focus on the shared goal of improving human health: KEs want to use their presence within the scientific community and with industry in order to champion patient needs; and pharma wants to safeguard a positive presence in healthcare, committed to addressing these needs.

Appropriate and responsible interactions between engaged stakeholders and pharma will help to achieve this shared goal. It is in pharma's best interest to research, develop and produce drugs that help healthcare professionals excel at their jobs.

The industry must achieve this within a highly regulated environment in which governments, trade associations, professional societies and individual company codes of practice are all in place to protect scientific values and medical integrity.

Medical innovation may be hindered if we further limit the industry from interacting with healthcare. Medical professionals and industry researchers may find it equally frustrating if this limits their professional aspirations.

Pharma is often held responsible for the rising costs of healthcare. Companies are rewarded for the risks taken to develop products when a successful treatment reaches the market. But it is easy to ignore the fact that products developed within pharma have consistently delivered improvements in human health for the past three decades.

Such significant improvements come at a developmental price that must be recouped and motivate further research and development.

Commercialisation in itself should not be dismissed by default, but should be appropriately guided such that the most likely result is expediency in producing new treatments.

In order to effectively develop and commercialise a brand, therefore, any company needs to be confident that it has the support of the right people who can provide clinical and experiential validation of the product.

Leading communication and consultancy companies are investing considerable research and development to help their pharmaceutical clients adopt new models of working with KEs through professional alignments to balance commercial needs with clinical necessities.

Developing transparency

One way to reduce concerns surrounding KE-pharma interactions is to educate physicians on pharmaceutical research and development and the clinical trial environment more intensively during their training at medical school, and as part of continuing medical education (CME).

But given that the value of pharma-sponsored CME is being questioned and in some cases cut or stopped, we may see an actual deterioration in drug developmental knowledge that could result in tomorrow's doctors having to practise yesterday's medicine. This will complicate the necessity of transparent KE-pharma practices.

Recently, Adelphi Communications supported a qualitative year-long consultation comprising in-depth interviews with more than 50 expert contributors to the KE-pharma relationship debate.

This consultation group - the International Ethically-Governed Interactions and Trust Body, or INTEGRITY as it is known - was founded as a voluntary, non-profit-making, independent, multi-disciplinary task force of therapy leaders, policy makers, ethicists and commercial communication experts to evaluate KE-pharma interactions.

The group concluded that there are three distinct improvements that can be easily made to the KE-pharma relationship without constraining either party with strict regulations.

1. Adhering to best practice

Despite nine sets of guidelines worldwide, research showed that the majority of KEs do not consult them as part of everyday practice. Many KEs felt that guidelines tend to focus too heavily on matters of hospitality, which they believe misrepresents their efforts to remain ethical in their interactions with pharma.

There is also concern that guidelines written by industry are used in political competition between companies. Many doctors simply prefer to adhere to their personal code of integrity.

But this is likely to change as legislation tightens to further regulate the actions of medical professionals.

A guide to good relationship practice is currently being validated by INTEGRITY and will centre on three questions:

* Do interactions encourage scientific information exchange or broaden physicians' skill sets with ultimate benefits to patient care?

* Do interactions require a minimal level of promotional literacy to guarantee their merit?

* Could the interaction be viewed as inappropriate and damaging to the participants' integrity?

2. Increasing promotional literacy

Industry and medical associations are currently working together on programmes to improve promotional literacy - that is, the ability to separate true clinical findings from sophisticated promotion - among medical students.

The programmes will help ensure medical professionals can differentiate between commercial and clinical benefits, and effectively judge the strengths and weaknesses of clinical trials.

There will also be help with deciphering the comparative outcome measures used in clinical trials and subjectively assessing data. This level of understanding should hopefully remove any potential emotive and authoritative distortion.

3. Authenticity and transparency

'Product-biased' sales representative visits are becoming less and less popular with doctors (around 40% are regularly cancelled and 70% last less than five minutes).

There is also is growing concern that these visits rely too much on the persuasive potential of 'food, flattery and friendship' that could affect clinical interpretation of information.

These issues, together with a growing public expectation that industry will reduce the amount of money spent on activities to engage with the medical profession, will further improve the adoption of more transparent relationships.

These new approaches to communicating should also help balance commercial and clinical interests.

Companies are already making internal changes to improve external relationships. Pharma and the medical-scientific community are keen to make the necessary moves to improve KE-pharma interactions.

This is evident from the cacophony of activity and debate surrounding the issues, including the increased frequency of articles in the medical literature and the popularity of key conferences.

Pharma interactions

Large companies like Pfizer and GlaxoSmithKline, smaller specialist companies like Stiefel Laboratories and Lundbeck, and device/consumer-healthcare focused companies like Allergan are all determined to defend the ethics and principles that underpin the ways that they interact with external KEs.

The different types of companies typically feel that the criticism of how they 'influence' the medical profession is both unjustified and unsubstantiated, while successful interactions are rarely celebrated.

Indeed, the fact that pharma readily awards grants for important meetings for scientific advancement or sponsors clinical projects without the inclusion of promotional information is often overlooked.

Gerry Thompson, EMEA marketing director at Stiefel, explains that: "Our vision is to be the most respected dermatology-focused speciality pharmaceutical company.

"We are rigorous beyond consumer standards and, as a privately owned company, we have family values that inculcate how we interact with experts and how we motivate ourselves internally, be that through adherence to formal compliance requirements or simply a desire to understand, listen to and give value to our customers' needs."

Like Stiefel, the Copenhagen-based company Lundbeck is keen to ensure it promotes an environment that is synergistic with, and sympathetic to, the shared goals of industry and clinicians in order to find therapeutic solutions.

Jeff Taylor, professional relations manager at Lundbeck UK and head of operations at the Lundbeck Institute, cites the Lundbeck Institute as one of many examples where "the medical community was initially cautious".

But now esteemed scientists have openly voiced their appreciation and respect that Lundbeck have provided educational forums that have helped physicians to improve their clinical skills and enabled them to conduct critical appraisal of products.

Allergan's marketing director for Europe, Africa and the Middle East, Simon Freedman, sums up this relationship perfectly and contests Moynihan's perception of KEs by explaining:

"Policies, protocols and public policing of relationships aside, as long as you're asking a professional to do something they're comfortable with then the relationship should be very straightforward.

"You give the data; ultimately it must be the expert's conclusions not the company's. We work in the most regulated industry and there is a lack of understanding amongst the public about just how strict those regulations are.

"Problems only arise when people try to push boundaries to make claims that are not supported by data. Usually this is not tolerated by either medical or pharmaceutical professionals.

"Of course there are guidelines to compensate clinicians who are at the top of their game for the time they need to work with industry on projects, but fundamentally the relationship is transparent and serves several beneficial purposes for patients."

In a similar vein, Pfizer has developed a standard operating procedure which focuses on 'living a shared agenda' with their customers and has clear lines of delineation. This is in addition to the company's standard operating procedure for customers, which has been in place for three years.

The new management approach is considering formalising guidance on activities with individual experts. The intention of setting this precedent would be to further strengthen both the company's integrity and the perceived integrity of the individual with whom they will work.

Walter Sheloff, customer manager for secondary care medical/scientific key opinion leaders, has been working to fine-tune these types of management approaches around KE interactions and is enthusiastic about how new policies should improve the perception of how industry conducts its relationships with experts.

He describes how the company is urging its employees "not to view doctors as KEs for Pfizer, but as experts in their field that Pfizer can engage with and learn from".

Pfizer engaged in a series of 'listening exercises' with its key customers, recognising that the perceptions of how it wants to work with the medical community "needed to change, needed to be seen to change and needs to be meaningful". Pfizer wants to "actively look for opportunities to work with experts, recognising that they are experts too and share patient-centered objectives".

This attitude is also evident at GlaxoSmithKline, where David Leather, medical director and acting head of the HIV Centre of Excellence, said that: "There is a code of practice on how to interact and stringent compliance procedures that are regularly audited, but an individual's conduct is also a living thing.

"Fundamentally, we are driven by strong moral values that are fully embedded in our everyday practices. It is our aspiration to engage with external experts on a solid ethical footing and we know that the public eye is upon us. Scrutiny is appropriate and expectations of good conduct are high."

Joint aspirations

Ultimately, the KE and the pharmaceutical professional will need to adopt, activate and align aspirations to create KE-pharma harmony - 'pharmony'. This will only be possible when all participants have an equal voice within a welcoming environment.

It is time to stop condemning KE-pharma interactions and start coaching better ways to collaborate to serve the real 'key experts' in this debate - the patients.

By focusing on a unified approach through the appropriate alignment of KEs and industry collaborations, KEs and pharma can work together to achieve their clinical and commercial aspirations.

If the academic, research and medical professions cooperate in this way, remarkable scientific innovations will be translated into health gains. Headlines, bickering and utopian ideals aside, this is ultimately all the public wants.

Box 1: Australia sets industry precedent for transparency

Australia has set a global precedent by obliging the pharmaceutical industry to publish details of money spent on medical education, including hospitality.

This transparent reporting of industry data is a first for the pharmaceutical industry.

The move was prompted by the Australian Competition and Consumer Commission (ACCC) and was a condition in authorising the industry's latest Code of Conduct.

Medicines Australia chief executive Ian Chalmers said he hoped the reports would help the public better understand the pharmaceutical industry's role in medical education. He added that "dialogue between those who manufacture medicines and those who prescribe them is critically important" to patients.

Medicines Australia adopts a zero tolerance approach to breaches of the Code of Conduct, with companies facing fines of up to AU$200,000 per breach.

Out of 30,000 events independently reviewed by international consulting firm Deloitte, 73 have been referred to a Code of Conduct committee for potential breaches of the Code, which bans gifts, entertainment and expensive meals.

Over the past year AU$63 million has been spent on medical education events in Australia and the average hospitality cost per person is AU$44.

Sunshine Act proposed in US

Meanwhile, in the US there are plans to introduce new laws regulating the field.

The US Senate has put forward legislation called the Physician Payments Sunshine Act, which would oblige pharmaceutical companies to disclose the amount of money given to doctors through a central registry.

Senator Chuck Grassley, one of the two congressmen to put forward the legislation said the public had a right to know whether a doctor had been given money that might affect prescribing habits.

"This bill is about letting the sun shine in so that the public can know," he said. "Whether it's dinner at a restaurant or tens of thousands of dollars or more in fees and travel, patients shouldn't be in the dark about whether their doctors are getting money from drug and device makers."

Pharmaceutical companies not reporting payments could face a fine of up to US$100,000 per violation.

Box 2: Creating a successful key expert-pharma relationship

* There needs to be joint responsibility - both parties must be clear about their relationships and the boundaries

* The relationship must be transparent, and authentic

* Focus on the shared goal of improving health gains

* Aim to engage and encourage collaboration, rather than 'influencing' KEs

* Adhere to the good relationship practices outlined in industry guidelines

* Ensure all participants have an equal voice.

Emma D'Arcy is founder and leader of scientific insights at Myphid.com. She can be contacted via e-mail at: emmad@myphid.com

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