Up Station Mountain Club: Douala AIDS Drug Controversy: Medical Council Says Trials Violated Ethical Norms

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Douala AIDS Drug Controversy: Medical Council Says Trials Violated Ethical Norms

By Clovis Atatah

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An ad hoc commission set up by the Cameroon National Medical Council, CNMC, to investigate into the controversial Tenofovir AIDS drug trials on sex workers in Douala has concluded that the promoters violated ethical norms.The findings of the commission, headed by Prof. Tetanye Ekoe, contradicted that of the audit commission set up by the Minister of Public Health that did not find any ethical problems with the clinical trials.

Briefing journalists on contents of the report of the commission in Yaounde on February 23, CNMC President, Dr Daniel Muna, said the press should be confident that the investigations were diligently done and in total independence.

Dr Muna, accompanied by other members of the CNMC handed the commission's report to the Minister of Public Health that same February 23. Thereafter, he issued a press release that reads:
"In the aftermath of the controversy upon the utilisation of Tenofovir in a clinical trial among sex professionals in Douala and after a meeting with the Minister of Health, the National Medical Council created on February 7, 2005 an ad hoc commission:

· to collect maximum information on the project
· find out eventual violation of principles of ethics relative to those types of clinical trials
· identify the sources of controversy

The commission met and interrogated the principal personalities taking part in the project as well as the principal actors involved. It also met under strict confidentiality some forty participants in the study, about 10 % of the total sample. It also consulted various scientific publications on the matter.

While recognising the value and opportunity of this clinical trial as well as others destined to fight the dreaded AIDS pandemic, the Medical Council nevertheless identified ethical deficiencies and dysfunctions.

In conformity with the Law No 90/36 of 10 August 1990 which in article 20 places the Medical Association 'under the supervision of the authority in charge of public health', the Medical Council has handed over the conclusions of its investigations along with the recommendations regarding the present and subsequent trials."

Dr Muna refused to give details of the findings of the commission, explaining that they would only do that when the Health Minister would have studied the report.Asked to comment on the discrepancies between their report and that of the ministerial audit commission, Dr Muna said they did not have access to the latter's report. He said this was positive because the report of the ministerial audit commission might have influenced their investigations.

He said their primordial concern is the patient and they would want to avoid misinformation. He said one of the things they realised in their investigations was that there was misconceptions and misinformation about the clinical trials. For instance, while it is generally believed that the sex workers in the Tenofovir trials were injected, they found out that no syringes were used. Similarly, unlike popular belief, the tablets given to participants were not infected with the HIV virus.
He said the Minister of Public Health was very open and encouraged rather than obstructed their investigations.

On whether there were different ethical standards for different medical doctors, given that their conclusion that there were ethical shortcomings contradicted the ministerial audit report, Prof Tetanye said that was not so. He explained that all ethical issues in medical research are universally guided by the Helsinki Declaration.

He said for there to be any clinical trial on humans, it should go through four stages, but he did not list them. He said, however, that there was a problem with the management of the Tenofovir trials. He said for any such trials to take place, they must be authorised by experts and must be vetted by an ethics body. Furthermore, the civil society ought to be involved so that the public understands and accepts the trials.

Dr Muna said they recommended that the clinical trials, which had been suspended by the Health Minister, could resume if the promoters rectify "certain things" that the commission identified.

Thursday, 24 February 2005 at 01:46 PM | Permalink

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