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Shared aspiration

A transparent and productive relationship between pharma and doctors can achieve  the common goal of improving patient health

Handprints in the sandThe perception of appropriate interactions between doctors and pharma has changed dramatically during the past five years. Considerable scepticism surrounds the intent of industry and there are concerns regarding the vulnerability of doctors in the relationship.

Increasingly stringent guidelines have been introduced across Europe. Doctors are now cornered into making multiple conflict of interest statements and the nature and consequences of their relationships are regularly debated. This is one of the most contentious issues in healthcare. Impassioned views range from physicians who pledge to have no interaction with any industry professionals at all, through to others who feel that collaborations are essential to underpin scientific advances. Those opposed to pharma's influence on medical professionals feel that financial gains from relationships may have a detrimental effect on or otherwise influence prescribing habits. Others feel that ethical issues are hindering the production of new or improved treatments that would benefit patients.

The INTEGRITY working group
A qualitative year-long consultation with more than 50 key contributors was conducted by the voluntary, non-profit-making, independent, multidisciplinary working group INTEGRITY (INTernational Ethically-GoveRned Interactions and Trust BodY). Therapy leaders, policy makers, ethicists and commercial communication experts came together to evaluate the benefits and difficulties of physician and pharmaceutical industry interactions (PPII). The European contributors to INTEGRITY questioned if the lessons observed and restrictions imposed on PPII in Australia and North America would translate into common European practices.

Despite some strong differences of opinion about PPII, those involved in the INTEGRITY consultation recognised that this is the critical time to consider how to establish and nourish balanced and authentic alliances between medical and pharmaceutical professionals.

This presents three core challenges:
1. Equipping the medical community with greater ëpromotional literacy' so they are able to discern between clinical information and commercial embellishment more readily.
2. Encouraging all parties to adopt everyday ëgood relationship practice' (GRP) as a protocol that reflects the spirit of all guidelines and limits potential for poor experiences to eclipse interactions of merit.
3. Ensuring that pharma and the medical community are more transparent about combining research, clinical and educational endeavours within a framework of professional networking.

Shared goals
A point on which all agree is that both pharma and healthcare professionals need to focus on the shared-goal of improving human health. We appear to have lost sight of shared aspirations between medical and pharmaceutical professionals. It is in both parties' interest to ensure that pharmaceutical products are safe, effective and useful and it is not credible to imply that healthcare professionals are easy victims to an industry that is readily able to fool them. Many of the European medical leaders who contributed to the INTEGRITY initiative found it condescending that they would be viewed as being malleable to ëmarketing ploys' and unable to conduct an ethical exchange with industry.

Positive publicity
It is true that the popular media are more likely to publish stories about drugs found to be unsafe or unsuitable, doctors who seem to have succumbed to financial incentives and reports that negative data have been withheld or played down. This no doubt fuels fears that interactions with the pharmaceutical industry are eroding medical professionalism. Yet, there were several examples cited within the group that industry readily awards grants for scientific meetings that are important to the research community without expectation that promotional information will be included. However, the fact is that everyday actions of researchers in industry are not as newsworthy, neither is a pharma company announcing they have sponsored an educational conference.

Innovation vs regulation
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. Yet it is easy to ignore that products developed within pharma have consistently delivered improvements in human health for the past three decades.

As Thomas Stossell, Professor of Medicine at Harvard describes, Today's much more effective, innovative, and safe medicine resulted almost entirely from technologies developed by private companies.

At worst, industry capitalises on our desire to live longer, healthier lives. As such, it is a victim of its own success in meeting our desires. When industry, physicians and academia collaborate, the proven most likely result is expediency in producing new treatments. The first step to recover the value of PPII is to accept that both parties need to assume accountability for the transparency and outcomes of their collaborations.

Improving education
One suggestion, to try to smooth this interaction and allay fears, is to include more teaching of pharmacy and drug development within medical training and as part of continuing medical education (CME). The pharmaceutical industry claims that 35 per cent of the estimated $9ó14bn it spends each year on pharmaceutical marketing goes towards educational support. If pharma-sponsored CME is no longer allowed it may result in tomorrow's doctors having to practice yesterday's medicine.

There are three distinct improvements that can be made easily without bombarding either party with more stringent regulations.

1. Improving promotional literacy
Industry and medical associations are currently working together to agree the content of programmes to improving promotional literacy among medics at student and post-graduate level. Key objectives will be to ensure that medical professionals:

  • Know how to disentangle commercial reasoning from clinical applicability
  • Can adequately judge the methodological qualities of clinical trials
  • Truly understand comparative outcome measures used in clinical trials
  • Are able to eliminate emotive and authoritative distortion to facilitate subjective assessment of data.

  • 2. Adhering to GRP

    Despite nine sets of guidelines worldwide the INTEGRITY initiative suggested that many doctors are not consulting them regularly as part of everyday practice. This seems to reflect the belief that pharma is more likely to be punished for breaking the rules than healthcare professionals and therefore more likely to take control to make sure both parties act in a compliant manner.

    Many doctors express the view that most of the guidelines focus too heavily on matters of hospitality, which they believe misrepresents their efforts to remain ethical and appropriate in their interactions with industry. There is also concern that guidelines written by industry are used in political competition between companies. Quite, simply, many doctors prefer to adhere to their personal code of integrity about interactions with industry. This is likely to change as legislation tightens to further restrict and regulate the actions of medical professionals.

    A guide to good relationship practice has been drafted and will be validated in coming months. This will centre on three questions along the lines of:

  • Does the interaction or series of interactions, encourage scientific exchange of information or lead to an enhanced skill that will ultimately benefit the care of people living with disease and/or enhance the knowledge of those aspiring to help people to overcome, manage or better understand a medical condition?
  • Does this interaction require a minimal level of promotional literacy and contextual arbitration to guarantee it is an interaction of merit - be that in the form of a discussion, debate, exchange of experience, education/knowledge update, personal opinion or release of specific product information?
  • Is there any possibility that this interaction could be viewed as an inappropriate activity which could damage the perception of any of the participants' intention and integrity to engage in a positive collaboration that furthers medical scientific understanding?
  • 3. Aligning aspirations
    Pharma and medical professionals are recognising that responsible leadership is no longer about influencing opinion but is instead about aligning aspirations and realising ambitions. Doctors want to champion patient needs and pharma wants to safeguard a positive presence in healthcare, committed to addressing these needs. There is a public expectation that industry will reduce the amount of money spent on activities to engage the medical profession. This, together with legal limits on financial exchanges and a demand for more transparent associations, will accelerate the adoption of more web and multimedia technologies that have public/extended access for review and approval. Both industry and doctors will have to get wise about the use and applicability of user-generated forms of interactions - such as professional web-based networks, blogging, podcasts and discussion forums - and the immediacy these offer.

    Web 2.0 tools are helping doctors and the public to interact more readily and engage in ways that should prove useful in the longer term. This is not to say that we will see the eradication of traditional types of interactions such as co-publication of articles for the medical literature, advisory boards or sponsored conference activities.

    Pharma and the medical-scientific community are keen to address these challenges and make the necessary moves to improve interactions.

    The Author
    Emma D'Arcy is leader of the INTEGRITY expert advisory panel. To comment on this feature please email pme@pmlive.com

    10th July 2008

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