[e-drug] ISDB and WHO-industry partnership

["Christophe Kopp" <Christophe.Kopp@wanadoo.fr>]

E-drug:  ISDB and WHO-industry partnership 
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This is the statement made by Margaret Ewen at the recent 
WHO/Public Health NGO Pharmaceuticals Roundtable Meeting
Geneva, Switzerland, May 1 & 2

WHO Interaction with Commercial Enterprises: ISDBs Perspective

Greetings

This session is about conflict of interest so I will do what I and ISDB
advocate, and make my declaration that I am the editor of a drug bulletin
produced by a regulatory authority, not an NGO.  However, today I represent
ISDB, an NGO with a long history of collaboration with WHO.  The most
significant in recent years is the current collaboration to produce a
manual which will provide editors with advice on starting and improving
their bulletins.  The publication of the manual later this year will be
especially welcome by the many new ISBD members, mostly from developing
countries, and we anticipate  the  manual  will stimulate the further
development of new bulletins in low income countries.

Drug bulletins aim to marry science with practice, and provide health
professionals and, in increasing numbers, consumers, with useful,
objective, balanced, evidence-based comparative information about medicines
and therapies. Their ultimate goal is to improve health outcomes by
changing how prescribers think and act and how consumers manage their
medication and healthcare. Credibility is a core element of a drug
bulletin¹s ability to attain this goal, and an essential part of achieving
this credibility is financial and editorial independence from the
pharmaceutical industry.

Independent drug bulletins try to counter drug promotion by the
pharmaceutical industry. The industry promotes its products by emphasising
positive aspects and rarely provides a balanced assessment of adverse
effects or other treatment options. Their mission is to maximise the bottom
line.

The need to counter drug promotion has never been greater as pharmaceutical
companies merge in order to maximise profits.  A result of intensified
competition for market share has been the use of more subtle methods of
increasing sales and developing relationships, such as funding consumer
support groups and, now, involvement in WHO programmes.

Drug bulletins and WHO share a similar objective of improving public
health.  Drug bulletins usually target only one country or region, whereas
WHO is all embracing and has world-wide influence.  It is important that
drug bulletins do not compromise their credibility; it is vital that WHO is
even more vigilant about protecting its reputation.

Certain direct and indirect interactions with pharmaceutical companies have
already tarnished WHO¹s credibility as an organisation and detracted from
the documents it produces.  For example, several of the recommendations in
the 1999 WHO/ISH guidelines on the management of hypertension have been
said to not represent the evidence (1). One recommendation is a target
reduction in blood pressure close to normotension rather than the more
widely accepted slightly higher target. The consequences of following these
guidelines could be needless drug treatment, over-medication, and the
increased potential for adverse reactions.  Obvious beneficiaries are
pharmaceutical companies who market antihypertensives. It has been
suggested the advice stems from a misinterpretation of the evidence.
There are several possible reasons for this misinterpretation, including an
honest error or a conflict of interest on the part of the experts.  Because
the press release of the guidelines was sponsored by Astra, who stand to
profit from their use, one tends to put more weight on a conflict of
interest being involved.

Following much criticism, WHO has stated they will review the hypertension
guidelines.  We would be grateful if you would share with us the timetable
and methodology for the review. ISDB members are concerned about the
potential influence of these guidelines.  Some members suggest WHO
announces the current hypertension guidelines should be discarded, others
would like WHO to distance itself from them.

Guidelines on WHO interaction with commercial enterprises are much needed
but WHO¹s approach in the July 1999 draft is disturbing.  It lacks detail
on most of the important issues e.g. it does not indicate how one should
distinguish when a company has a direct commercial interest and when it
does not. WHO appears to be convinced that partnerships with commercial
enterprises are beneficial and overlooks the inherent conflict of interest
between public health and commercial goals.

ISDB has 3 major concerns with the draft guideline on interaction with
commercial enterprises:
? the development of WHO treatment guidelines and recommendations
? publications, and
? seconded personnel.

WHO is proposing to allow donations from commercial enterprises, albeit
those who do not have a direct commercial interest, in the development of
guidelines and recommendations. We fail to see how any sort of company
involvement in the development of guidelines is in the interest of public
health. Accepting donations from companies places WHO in a compromised
position, and could jeopardise the value of the advice and image of the
organisation.  It would be naive to not recognise that the donor company
will be expecting a quid pro quo such as financial gain or being seen as
one of the ³good guys².  The only way to ensure the credibility of any WHO
guidelines or recommendations is to exclude all commercial enterprises from
the development process.

Likewise, WHO should not permit commercial enterprises of any sort to
directly fund publications as the information may be compromised or may be
regarded as compromised.  Prescribers will likely disregard information if
it is distributed by a pharmaceutical company, and believe it trivialised
if any other company, such as an insurance company or travel company,
sponsors it. It is essential that WHO retains its editorial and publishing
autonomy, and is seen to be independent of company involvement.

Seconding personnel to WHO from the commercial sector producing health care
products is also unacceptable to ISDB.  Again, there is a risk of conflict
of interest. Anyone interacting with WHO must be assured that the person he
or she is dealing with is a WHO employee rather than someone with divided
loyalty.

There are instances where collaboration with pharmaceutical companies is
acceptable, and even necessary, and benefits WHO¹s mission.  An example is
the development of new medicines to treat neglected diseases.  Where such
collaborations occur, it is essential that an agreement be drafted stating
the purpose, role, timeframe and financial input of the company, and this
agreement should be freely accessible.

Donations are needed for WHO initiatives.  ISDB believes the only
acceptable way for WHO to avoid conflicts of interest is to establish a
fund where unearmarked donations are made to the organisation rather than
specific programmes or publications.

In conclusion, ISDB members have expertise in formulating prescribing
advice and would welcome participation in the development of prescribing
guidelines, conditional on the exclusion of commercial sector sponsorship
and expertise. We believe that the intended users of information should
participate in the process of guideline development rather than those who
wish to profit from it.

Reference: Rev Prescr May 1999;19(195):378-381

Margaret Ewen, General Secretary
International Society of Drug Bulletins
PO Box 5013
Wellington
New Zealand

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