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.

