Malawi's illegal clinical trials

Police have arrested a health worker at St Luke's Hospital near Mount Malosa in southern Malawi for using unauthorised drugs on 20 patients suffering from incurable tumours, as full-blown Aids attacked their immune system.

Thomeck Nyaude, the police public relations officer for the Zomba district, confirmed that investigations are under way into claims that six patients may have died. Further charges may result.

The suspect, Tanzania-born Thadeo Mac'osano, has pleaded not guilty to contravening the Pharmacy Medicine and Poison Board regulations controlling the conduct of medical tests on humans.The penalties range from seven years to life imprisonment.

Mac'osano is not a doctor, but is registered with the Medical Council of Malawi as a clinician. He trained as a medical technician at the Malamulo College of Health Science in the town of Makwasa for four years and has a diploma in palliative care from Makerere University in Uganda.

"The clinical trials were not approved by the country's science and ethical committee as required by law. The suspect used randomised controlled trials on HIV-positive Kaposi's sarcoma patients," Aaron Sosola, acting registrar of the country's Pharmacy Medicine and Poison Board (PMPB), told SciDev.Net.

Mac'osano's application to run such tests on humans was rejected in 2006 in part because it did not adhere to international standards protecting the rights of the patients, Sosola said.

He seems to have applied to a series of bodies meant to provide oversight of such tests including the College of Medicine Research and Ethical Committee headed by professor Robin Broadhead, as well as the HIV unit at the ministry of health. Neither body appears to have responded to his requests, probably because Mac'osano is not an oncologist (cancer specialist) let alone a doctor and had no research background.

Mac'osano also did not have approval from the National Health Science Research Committee (NHSRC) headed by paediatrician Charles Mwansambo at Kamuzu Central Hospital in Lilongwe, said Damson Kathyola, head of research and planning at the ministry of health.

However, suspicions by hospital administrators when Mac'osano announced his preliminary findings prompted an investigation.