E-DRUG: Open letter to DG WHO Dr. Brundtland (WHO and pharmaceutical
industry)
----------------------------------------------------------------------
This is the text of a letter that was sent to Dr Brundtland on 18 May
1999
Amsterdam, 18 May 1999
Re: WHO's partnership with the pharmaceutical industry
Dear Dr Brundtland,
Health Action International (HAI) has been monitoring the developments
taking place in the "new" WHO under your leadership closely and we have
been encouraged by your initiatives to build closer partnerships for
public interest NGOs also working to promote public health. However,
members of the HAI international network have asked us to write to you
now to express our serious concern about how WHO's partnership with
industry appears to be evolving. We are concerned that recent
developments involving drug industry sponsorship directly affect the
role that the WHO will play in the world of public health.
Through several postings on the Internet mailing list E-Drug we have
discovered that the pharmaceutical company, MSD, has succeeded in
seconding a senior staff member to the staff of the WHO Tobacco Free
Initiative (TFI).
According to an internal MSD announcement, this is a "pioneering
arrangement", "a marvellous opportunity to continue to build bridges",
and the corporation expects the person to be an "effective ambassador".
HAI greets this news with alarm. We believe there is a fundamental
difference between the core purpose of WHO -- which is to serve the
public interest -- and the aim of pharmaceutical companies, which is to
maximise profits for their shareholders. HAI is concerned that this type
of industry secondment may become common place within the organization
as it strives to carry out its mandate on limited funds.
HAI and many other public interest NGOs promoting public health
currently cooperate with WHO on the basis of a clear understanding of
each other's responsibilities, missions and mutual recognition of the
need for independence. We have deep doubts about whether it will be
possible to know if in the future when communicating with WHO the WHO
staff member is actually accountable to a public organisation or the
international commercial sector.
HAI is also concerned about how WHO is working with more general
partnerships with industry lately. We have followed the recent
controversy about the new Guidelines for the Management of Hypertension
prepared by a WHO/International Society of Hypertension (ISH) Working
Group. Several people have pointed out that the task force ignored
ground rules of clinical assessment and placed a great deal of weight on
the results of two trials funded by pharmaceutical companies (1).
However, the main issue for us is not only the recommendations
themselves, but also the process that was used to arrive at them.
According to our information, the sponsor of one of the trials funded
the press conference given by the working group, and the company's logo
appears on the welcome page of the ISH web site. Independent review, for
example in La Revue Prescrire(2), of this trial shows that it provides
no evidence in the study to recommend aiming for a blood pressure
below 140/90 in non-diabetics. The corporate sponsor of the trial has
been promoting the guidelines, claiming that the study shows the optimal
target diastolic blood pressure to be as low as 83 to 85 mm Hg. We fear
that in this case WHO has not been able to prevent conflict of
interests. We also fear that because of this WHO has endorsed
recommendations that will be used to encourage an increased use of
anti-hypertensive drugs, at great expense, and for little public health
benefit.
Both of these recent examples have raised a number of fundamental
questions about how the WHO is currently working to avoid any actual
or perceived conflict of interest when accepting funds from and working
closely with commercial enterprises. In the spirit of our earlier open
and frank discussions on drug policy issues we would like to ask you to
clarify the following questions:
On the principles for cooperation with the commercial sector
- We note that WHO has used draft Guidelines on the Acceptability of
Donations from Commercial Enterprises since 1996. When does WHO plan to
finalise and adopt its principles for cooperation with the commercial
sector and how does it plan to implement these? What procedure do you
follow to finalise the guidelines? Do you intend to consult other
international agencies and bodies and use their experiences in
finalising the guidelines? Will the guidelines be made publicly
available? When?
On secondment
- Given the concerns raised above about the conflicts of interest
between the aims of the employee of a pharmaceutical firm and the aims
of WHO, we think it is impossible to avoid conflict of interest in
secondments. The only option we see is to specifically exclude this
option in future guidelines for WHO interaction with the industry and
not to establish a principle that might be followed by other programmes.
In case you do plan to keep this option open, we think that there is an
urgent need to clarify the procedure used for deciding on secondments.
How does WHO plan to ensure that the secondment of industry
representatives does not cause any real or perceived conflict of
interest?
On transparency
- In your May 4 response to the open letter on the hypertension
guidelines by the members of WONCA, the international association of
family doctors, you mention the recent establishment of the Committee on
Private Sector Collaboration. Who are the members of the Committee and
which Guidelines will the Committee use in monitoring private sector
collaboration? Will every collaboration initiative be subject to
monitoring by this committee? How does the WHO intend to promote
transparency of its internal monitoring process?
On principles and methodologies for the elaboration of treatment
guidelines
- In your May 4 letter you also indicate that the WHO Noncommunicable
Disease Cluster is developing new principles and methodologies for the
elaboration of future treatment guidelines. This raises the question of
what principles and methodologies are now being used. Would you please
send us a copy? Could you please explain how WHO plans to avoid conflict
of interest in developing guidelines and standards? Would you also
please explain how the new methodologies and principles will be
developed? And with input from whom?
We look forward to receiving your answers on the above questions. We
also think that the WHO-NGO Roundtable process could be an appropriate
forum for further discussion on how public interest NGOs can be
substantially involved in addressing the issues raised in this letter.
HAI sees great potential for the WHO in the years ahead and we are
convinced that clarity on these issues will only serve to benefit all
partnerships and collaborative efforts that are presently being
developed with WHO.
Yours sincerely,
Bas van der Heide
Coordinator HAI Europe
Amsterdam
The Netherlands
Email: hai@hai.antenna.nl
On behalf of:
Dr. K. Balasubramaniam, Coordinator HAI Asia/Pacific (ARDA)
Beryl Leach, Coordinator HAI Africa
Roberto Lopez Linares, Coordinator HAI Latin America (AIS)
c.c.
Dr M. Scholtz, EXD HTP
Dr J. Quick, Director EDM
1. Among others: Bradbury J. In: Lancet 1999; 353: 563 Open letter to
Brundtland "HOT: can we turn WHO around?" and several postings on
E-Drug.
2. See "Les traitements antihypertenseurs". Rev Prescr 1999; 19 (194):
288-296 and "Les recommandations contestables et contest�es de l'OMS
dans
l'HTA" Rev Prescr 1999; 19 (195): 378-381
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.