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.

“We seek clarification whether the qualification of the investigator, Thadeo Mac’osano, was vetted by the council,’’ states a letter to the NHSRC last month by St Luke’s Hospital principal administrator Anthony Chilembwe.

Chilembwe also asks “whether the council approved of the capacity of the investigator to conduct a scientific study of this nature?”

This month PMPB drug registration officers Enifa Man’ganya and Mtwalo Jere visited the hospital with Freeschard Nyirenda, head of the criminal investigation unit’s drug section. A day later Mike Kachedwa and Austin Mnthambala, monitoring and evaluation officers for NHSRC, visited the hospital and halted the trials, saying the original 20 patients did not give their written informed consent, the drugs used were not approved for use on patients with Kaposi’s sarcoma and Mac’osana was a technician who should not have been carrying out such tests.

The surviving patients are being monitored by a specialised medical practitioner at another hospital.

Mac’osano, represented by lawyers from Russell and Smith Associates, has been granted bail by the high court sitting in Zomba. Despite being advised by his lawyers not to speak, he told SciDev.Net that he conducted a cohort study only - an investigation of a group of people who share a common characteristic - although a medicinal cohort is not normally identified as a group of people who already share a disease.

“It is not true that six people died as a result of the study. The actual number is five. These patients did not die because of the drugs administered, but because of advanced cancer,” Mac’osano told SciDev.Net. He also said he enrolled only 15 patients in the study as opposed to 20.

“One of the patients is Frank Chilembwe, the brother of the hospital administrator who rushed to report this issue to PMPB. He is healed and fit at the moment. The whole issue is simply internal politics and that management is jealous of me as a foreigner,” Mac’osana said.
He is scheduled to appear in court on November 8. - www.SciDev.Net

Charles Mkoka is an environmental and science writer and columnist based in Lilongwe, Malawi, and a member of the World Federation of Science Journalists’ peer-to-peer mentoring programme. For full story, check the Africa section of SciDev.Net

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