Tuesday, February 03, 2009

Fascinating research ethics case from Malawi

Sci.Dev broke a story back in November about a research ethics scandal in Malawi. You have to be careful with this sort of juicy information: now there is a legal case in progress, and the information leaked to the press up to this point is threadbare. Let's go over what, according to the press, is known.

  • The suspect is a Mr. Thadeo Mac'osano is described as a 'medic' who received medical technician training 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. What he is not is a doctor, nor is there evidence so far to indicate that he has training in biomedical research.

  • Mac'osano is accused of conducting biomedical research on patients with HIV/AIDS and kaposi sarcoma without gaining regulatory approval from scientific and ethical boards in Malawi. His trial involved 20 patients (Mac'osano himself says 15), six of whom died, but it is not known whether they died from the study drugs or from late-stage AIDS and/or cancer. The study drugs included the antibiotic bleomycin, vincristine and the intravenous drug doxorubicin, and possibly also actinomycin and cyclophosphamide.

  • The charge against Mac'osana is 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.

  • According to Aaron Sosola, acting registrar of the country's Pharmacy Medicine and Poison Board (PMPB), Mac'osano submitted an application to the PMPB to conduct palliative care studies in 2006, but this was rejected because it failed to provide adequate protections for research participants. In another news article, however, it states that the submission was 'ignored', neither rejected nor approved.

  • Back in October, PMPB and National Health Science Research Committee officials visited St. Luke's Hospital in southern Malawi where the study was conducted. 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.

  • Officials at St. Luke's Hospital did not seem to know that Mac'osano had applied to PMPB to conduct research at their facility. The PMPB seems to have simply let his file gather dust without contacting St. Luke's to find out what was going on.

  • For Mac'osano's part, he seems to be playing the immigrant card: The whole issue is simply internal politics, and that management is jealous of me as a foreigner." Mac'osano is Tanzanian.

The whole situation seems fairly murky, but a few remarks on how this looks at first glance. First, this seems to be a homebrewed research ethics scandal, not a Constant Gardener sort of affair involving foreign pharaceutical companies and their minions. Second, the lines of communication between institutions that are supposed to ensure the scientific validity and ethical quality of clinical trials look to be in pretty rough shape. If a regulatory board sits on submissions instead of seriously reviewing them and providing a judgment, then such a board is pointless. That does not justify Mac'osano going ahead without ethics approval. The fact that he could do that points to something else: a general lack of appreciation for research ethics on his part and on the part of those involved in or affected by his research. Because that's the thing: a clinical trial on 20 terminally ill patients in a clinic is not something that you do alone or something that can be kept completely secret. Maybe it is only when Mac'osano was crazy enough to present findings that his unapproved research became too obvious (and self-incriminating) for hospital administration to ignore.

But we will have to wait and see. The court may produce a reasonable facsimile of the truth.

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Blogger lisa_chensvold said...

Interesting post, Prof. Rennie. I hadn't heard about the case. Thanks for breaking it down for us.

I'm going to link to the post on the UNC Institute for Global Health and Infectious Diseases blog. Global bioethics blog is already on our blogroll. It would be great if you would consider adding us to yours.

Lisa Chensvold
Director of Communications
Institute for Global Health and Infectious Diseases
University of North Carolina

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