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

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

2. See "Les traitements antihypertenseurs". Rev Prescr 1999; 19 (194): 288-296 and "Les recommandations contestables et contestées de l'OMS dans l'HTA"

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

Go to Dr. Brundtland's response and HAI critique