One Costly Mistake

By Tunde Sanni (THISDAY ONLINE-Nigeria) 24 November 2008: Efforts by medical experts to test-run an anti-HIV drug on some sex workers proved fatal as the drug rather than boosting , caused the collapse of the body immunity of the infected workers with the deadly virus.

*MODERATOR'S NOTE: Please note that this article is inaccurate and misinformed. Additionally, the journalist uses inflammatory language and miscontrues the research process. Responses are being planned to address the factual errors in this reporting.

http://www.thisdayonline.com/nview.php?id=129064


The ladies casually described as street workers by Professor Rasheed Bakare, an expert in the study of the prevention of HIV/AIDS strolled into the hall elegantly. Some were aware of their new status, while others oblivious as they chatted with each other. For those who were oblivious of their new status, they were soon faced with the stark reality of their stupidity as the don dropped a bombshell: they are all new carriers of the deadly HIV virus.

Observers at the hall which included newsmen, counselors and hospital workers who were apparently waiting to watch the reactions of the street workers, were dazed as the ladies looked away as if nothing has gone wrong with them.

The counselors soon picked the challenge as they embarked on their job, advising the street workers on the do's and don'ts. They were given a new marching order, which has become a common refrain, always use condom. To arrive at their new destinations, according to Bakare, the ladies were part of a crowd of ladies estimated at about 2, 500 that were assembled by hospital authorities to test the upcoming Savvy Gel, a test that had been on for sometime now.

The don explained that the result of the research, which was conducted between August 2004 and August 2005 in collaboration with Family Health International, was borne out of intense research to find a drug that would cure the deadly virus and put a stop to the awesome fear it always instilled in the minds of the two sexes each time they think about sex.

Bakare told newsmen ahead of dropping the bombshell of the new status of the ladies that the gel was not as effective as anticipated and told them to stop using it henceforth. One version, according to him, is the real Savvy product, which contains the right ingredient known as microbicides that can kill virus and the placebo, while the other version is without any ingredient. He said two versions of the Savvy Gel were tested.

He revealed that each of the ladies participants in the Savvy and Placebo groups was loaded with no fewer than 60 condoms every month for them to use during sexual period in order to adequately protect themselves from the killer virus. He said prior to the commencement of the study, the hospital screened all the 2,153 participants and were confirmed HIV negative, while those that tested positive during the screening were excluded from the experiment. It however afforded them free treatment by the hospital.

Bakare noted that the research work, also known as double-blinded placebo study, was stopped in August 2006 after results showed that the infection rate was slightly higher in the women, using Savvy Gel than in the group using the placebo gel.

Out of 2,153 participants who were divided into the Savvy and placebo groups, 21 contacted the virus as against 12 in the placebo group after the 12 months of usage. The research result showed that the HIV infection rate was slightly higher in the women using Savvy Gel than in the group using the placebo gel. There were 33 infections among the 2,153 participants before stopping the trial (21 in the Savvy group; 12 in the placebo group.

The difference of nine infections between the two groups was not statistically significant. This means that it was small enough that it could have occurred by chance. But in a contradictory manner, the don argued that with the difference of nine infections, scientists cannot be sure whether the gel affected users risk of HIV infection.

On the study, he said, equally measured the number of medical problems of reproductive tract and sexually transmitted infections occurring among women in both Savvy and Placebo groups were equal, saying none of the serious medical problems reported was related to gel use.

Apart from prevention against HIV, the medical chief disclosed that the study also measured the number of medical problems occurring among women in the two groups, that is, Savvy and placebo, but the numbers were almost the same. He said that medical problems of the reproductive tract and sexually transmitted infections were also equal in both gel groups. None of the serious medical problems reported was related to gel use.

But the experiment, Bakare revealed was not limited to Nigeria as such experiment had earlier been carried out in some other African countries which included South Africa, Republic of Benin, Gambia and Ghana, on the ineffectiveness of the drug in preventing the spread of the virus.

Afraid that the ladies might resort to litigation to challenge or expose the fraud in the experiment, Bakare denied that the ladies were financially induced for the experiment. According to him, the hospital had been on the experiment for two years where forms of intention were given to each of the guinea pigs in the test to read, digest and append their signatures as appropriate for the experiment. He maintained that for one year, the ladies were told of the implications of the experiment which he said the sex workers did not object to with some of them opting for the experiment while those that opted out were left alone.

The don argued that all the ladies that agreed with the terms of the experiment were all screened to know their HIV/AIDS status, while as he explained those that tested positive were excluded but were being treated by the hospital while those that tested negative to the screening received the gel and additional packets of condom to kick start the experiment.

He however lamented the unfaithfulness of the sex workers to the gel as he accused some of them of attempting to make quick money by allegedly selling the drugs to drug sellers and traditional herbal hawkers and spreading the wrong information that Savvy was a good drug against HIV.

Perhaps the urge to make some fast money from the gel, according to the don might have been responsible for the failure of the sex workers to use the gel, as required thus creating the impression of its ineffectiveness.

Besides, the don accused the sex workers of refusing to use the gel with condoms as instructed blaming the ladies for apparently sabotaging the research of the gel. He restated that each of the street workers that were used for the experiment was given 60 condoms, which is meant to be used simultaneously with the gel for the period of the experiment.

Fundamental human right activists have however faulted the claims of Bakare and blamed the HIV/AIDS drug research experts of insincerity wondering the need for condoms when the gel was just being introduced into the system. Kamil Oredein of the Human Rights Protection Agency (HURPA) declared that the researchers' action was criminal and demanded for their arrests.

He pointed to the contradictions in the claim of the don stating that 33 infections out of 2, 000 experiments should not have amounted to outright condemnation of the gel. This is new drug and a mere 33 respondents are infected out of over 2, 000 respondents and you say such experiment is not successful. Again I am still at a loss on the need to still give each of the respondents packets of condom. For what reason when you have indicated that you wanted to test a particular product. They have succeeded in infecting these people with HIV because they saw that they are helpless. It is wrong, criminal and inhuman, he said.