Medic charged with unauthorised drug trials in Malawi
[LILONGWE] Police have arrested a hospital technician on charges of conducting unauthorised and unsupervised chemotherapy drug trials on cancer-suffering HIV/AIDS patients in a hospital in southern Malawi.
Investigations are underway into six deaths among 20 patients being treated for AIDS-related Kaposi's sarcoma at St Luke's Hospital near Mount Malosa.
The accused, Thadeo Mac'osano, appeared in the Zomba High Court on 14 October, charged with contravening Malawi's Pharmacy Medicine and Poison Board (PMPB) regulations controlling the conduct of medical tests on humans. He pleaded not guilty, and will appear in court again next week (18 November).
Mac'osano conducted randomised controlled drug trials on the patients — in which they were randomly assigned to receive a treatment or a control. He told SciDev.Net that he enrolled only 15 people on the study, not 20. He also says that only five of the patients in the trial died, and that this was not because of the drugs he administered but because of advanced cancer.
Mac'osano's actions were discovered when he reported preliminary findings on using the antibiotic bleomycin, vincristine and the intravenous drug doxorubicin in palliative chemotherapy to hospital staff, prompting an immediate investigation.
According to the hospital's written communications with the PMPB, he also used a combination of other chemotherapy agents, including the antibiotic actinomycin and cyclophosphamide.
"The clinical trials were not approved by the country's science and ethical committee, as required by law," Aaron Sosola, acting registrar of the PMPB, told SciDev.Net.
He added that trial regulations require a qualified cancer specialist to monitor dosages.
Mac'osano trained as a medical technician at Malawi's Malamulo College of Health Science. He has a diploma in palliative care and is registered with the Medical Council of Malawi, an umbrella body of medical practitioners.
In 2006 he applied to the PMPB to run palliative drug trials, but his application was ignored — neither rejected nor approved — partly because it did not adequately protect the rights of the patients, says Sosola.
Mac'osano applied to a series of bodies meant to oversee such tests, including the College of Medicine Research and Ethical Committee (COMREC), as well as to Kelita Kamoto, head of the HIV unit at Malawi's ministry of health. Kamoto said she was too busy to attend to the request.
Mac'osano also lacked approval from the National Health Science Research Committee (NHSRC), says Damson Kathyola, head of research and planning at the Ministry of Health. NHSRC is the overall approving body for such trials, but delegates some of its responsibilities to other bodies, including COMREC.
SciDev.Net has seen documentation suggesting that none of the regulatory bodies followed up Mac'osano's requests by asking the hospital why a relatively low-level technician was asking for permission to conduct such trials.
"We seek clarification whether the qualifications of the investigator, Thadeo Mac' osano, were vetted by the council," states a letter to the NHSRC (12 September 2008) 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?"
Last month (3 October) PMPB and NHSRC officials visited the hospital. They 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 that Mac'osano should not have been carrying out such tests.
Mac'osano, who was granted bail by the court, told SciDev.Net: "The whole issue is simply internal politics, and that management is jealous of me as a foreigner." Mac'osano is originally from Tanzania.