Ethics committees in western and central Africa: concrete foundations.

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa.

Vaccines administered simultaneously: directions for new combination vaccines based on an historical review of the literature.

Objectives: The recognized benefits of administering vaccines simultaneously has encouraged vaccine producers to develop combination vaccines. If contemporary research and development can realize vaccines that achieve the current standards for safety, immunogenicity, and efficacy, other specific vaccine associations may also merit reconsideration as combination vaccines.

Methods: An historical review of the vaccine association literature reveals two important themes: first, the programs of mass vaccination, in particular, the eradication of smallpox, sessions where multiple vaccines (other than the smallpox vaccine) were given concurrently, and the Expanded Programme on Immunization (EPI); and, second, the domain of travel vaccines, including travellers to a disease-endemic country (such as migrants, tourists, military personnel, or expatriates) and WHO requirements for international travellers.

[Surveillance of the safety of intravesical BCG therapy in France: quantitative analysis of serious adverse events notified over a period of five years].

Intravesical BCG therapy remains the first-line prophylactic treatment for recurrent superficial bladder tumours. However, the safety of this drug requires close and rigorous surveillance due to rare, but sometimes serious complications reported after treatment. A quantitative analysis of serious adverse events (SAE) notified in France since marketing of BCG for intravesical immunotherapy (Connaught strain) and over a five-year period (September 1996-September 2001) revealed the following results: During this period, 158 SAEs were spontaneously reported to the Aventis Pasteur Central Pharmacovigilance Department.

[Can ofloxacin constitute an alternative antitubercular treatment for BCG hepatitis?].

The authors report a case of severe BCG hepatitis resistant to tuberculostatic therapy and treated with ofloxacin. Modern antibiotics, such as certain fluoroquinolones, can constitute an alternative to tuberculostatic therapy in the management of serious adverse effects of BCG therapy.