For Quality, Essential, Generic Medicines
Chapter 4: Drug Marketing
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On Symposia and other Scientific Meetings

IFPMA : On Symposia and other Scientific Meetings

Symposia, congresses and the like are indispensable for the dissemination of knowledge and experience. Scientific objectives should be the principal focus in arranging such meetings, and entertainment and other hospitality shall not be inconsistent with such objectives.

HAI Comments : On Symposia and other Scientific Meetings

(1) The organisation by pharmaceutical manufacturers or distributors of symposia and other scientific meetings should only be permitted if approval for such a meeting has been granted by the relevant national or international health worker association, health institution or government department, an independent panel of scientists and/or health workers has been set up to review the content of the meeting, and full disclosure of the sponsorship is stated in all communications related to the meeting, and at the meeting itself. (2) Partial sponsorship of such meetings may be permitted if such sponsorship is requested by the organisers, subject to the full disclosure of the sponsorship.

Source: Kanji, Najmi, et al. Drugs Policy in Developing Countries. London: Zed Books, 1992, pp.128-131.


"Postmarketing assessment" is often little more than wishful thinking

For severe and intractable conditions the regulatory authorities may be inclined to approve new drugs with clear clinical benefit but a poorly documented risk of major side-effects. One solution (often chosen by the French authorities) is to licence the new drug for "hospital use only", with the proviso that the hospital specialists carry out further studies. This is an attractive solution at first sight, as it should mean that patients are properly enrolled and followed-up.

In practice, however, this postmarketing hospital assessment often fails. The case of vigabatrin is an excellent example. This drug is possibly useful for some epileptic patients whose seizures are not controlled by other available agents. When vigabatrin was initially released into the market, animal studies left doubts as to possible ocular and neurological toxicity. Hospital neurologists and regional pharmacovigilance centres were therefore requested to monitor all treated patients. Five years later the data are a blight on to French hospital medicine: only 200 patients have been studied, and a quarter of them were lost to follow-up (mean follow-up 2 years). Moreover, the results have only been published on one page of a conference report (inadequate data on the 8 cases of ocular toxicity for example).

Will the French medicines agency simply ignore this fiasco or learn from experience? There is currently talk of auditing the performance of hospital units, but will the relevant authorities have the courage to remonstrate with certain specialists for their failure to act?

Source : Editorial in Prescrire International, October 1996

       
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