HIV/AIDS, PROFIT AND FUNDAMENTAL HUMAN RIGHTS
ANC Today 16 - 22 Feb. 2001
The story of nonoxynol-9, known as N-9, an active ingredient used in
chemical barriers to HIV and STD transmission, raises disturbing questions about
research ethics, drug company profits and the role in Africa of international
Products designed to provide a chemical barrier to HIV and
STD transmission, such as N-9, are called microbicides.
According to a circular of the US Centres for Disease
Control (CDC), dated 4 August 2000: "From 1996 until May 2000, UNAIDS
sponsored a study of the effectiveness of a gel which contained 52.5 milligrams
of N-9., compared to an inactive gel. The study was conducted in several
locations in Africa. Nearly 1,000 HIV-negative commercial sex workers
were enrolled in the trial, and all women were counselled to use condoms
consistently and correctly. In addition to condom use, the women were
asked to use a vaginal gel each time they had intercourse. Half of the
women were provided a placebo (non-active) gel and half of the women received
an N-9 gel."
Later, we will report on the results of this trial and the
recommendations of the CDC. But before this, we have to give a short account of
the history of N-9.
The conclusions of a 1992 N-9 study were published in the
journal JAMA 1992 July 22-29; 268(4):477-82 and stated that: "Genital
ulcers and vulvitis occurred with increased frequency in nonoxynol 9 sponge
users. We (who conducted the trial) were unable to demonstrate that nonoxynol 9
sponge use was effective in reducing the risk of HIV infection among highly
exposed women." The trial referred to here was conducted among sex workers
in Kenya in 1992.
The results of another study were published in 1993 in the
International Journal on STD and AIDS 1993 May-June; 4(3):165-70. This study
concluded that: "The rate of epithelial disruption (genital ulcers) for
women using N-9 4/day was five times greater than that of placebo users."
After another study conducted in Kenya, the Journal of
Infectious Diseases 1991 February; 163(2):233-9, had concluded that genital
ulcers were associated with increased risk of HIV-1 infection.
By the time UNAIDS began its studies in 1996, published scientific
knowledge was that:
- genital ulcers increased the risk of HIV infection;
- the use of N-9 increased the incidence of genital
- more frequent use of N-9 led to a higher incidence of
The August 2000 CDC circular to which we have referred
said that the results of the UNAIDS trial were reported at the 2000 Durban
International AIDS Conference, as follows:
"At the end of the trial, researchers found that the
women who used N-9 gel had become infected with HIV at about a 50% higher rate
than women who used the placebo gel. Further, the more frequently women used
only N-9 gel (without a condom) to protect themselves, the higher their risk of
becoming infected. Simply stated, N-9 did not protect against HIV infection and
may have caused more transmission. Women who used N-9 also had more vaginal
lesions, which might have facilitated HIV transmission."
As we now know, these precise results of N-9, announced in
2000, were already publicly known by 1993. And yet UNAIDS began its trial in
1996, knowing that N-9 increased the risk of HIV infection, especially among
those who might use the microbicide with high frequency, such as prostitutes.
Despite this knowledge, after the results were announced at
the Durban AIDS Conference, Dr Joseph Perriens of UNAIDS could still say:
"We were dismayed to find out that the group using N-9 gel had a higher
rate of HIV infection than the group using a placebo."
South Africa was one of the African countries in which
UNAIDS conducted its trial. In a press release issued in Durban on 12 July,
2000, an organisation named AEGiS reported that the sites for the South African
trial were Durban and Johannesburg.
It also reported that the Principal Investigators
responsible for the trial in these two cities were, respectively, Dr S. Salim
Abdool Karim and Dr Helen Rees. At the same time as he was leading
investigations into the efficacy of a chemical compound that was known to be
extremely harmful, Dr Karim was head of AIDS Research at our Medical Research
Council. For her part, Dr Rees was Chairperson of the Medicines Control Council,
the body charged with the responsibility of licensing drugs and medicines.
The Business Day edition of 13 July 2000 reported Dr Rees as
'caution(ing) that the (negative) results were not conclusive and more work
needed to be done on the issue. She pointed out, for instance, that it was
possible that the group using the placebo (or substitute with N-9) may have been
exposed to a more active microbicide.' Presumably by saying that "more work
needed to be done", she meant that more women needed to be exposed to the
highly toxic N-9.
In its edition of August 14, 2000, the Washington Post
reported that: "Two U.S.-funded studies involving nonoxynol-9 are
underway in African women at risk of HIV. One, sponsored by the Agency
for International Development to test the ability of nonoxynol-9 gel to
prevent sexually transmitted diseases among a group of women in Cameroon,
is due to be completed in September. The other, a study sponsored by the
NIAID to look for protection against HIV in women in Zimbabwe and Malawi,
is getting underway. In light of the disturbing findings, reported last
month at the 13th International AIDS Conference in Durban, South Africa,
researchers have abandoned plans to test nonoxynol-9 in that study, said
Ward Cates of Family Health International, a non-profit health research
organisation that is co-ordinating the project. Cates said there is no
evidence that nonoxynol-9 is harmful to women when used as a contraceptive.
Nonoxynol-9 is a detergent that is a contraceptive and a microbicide (or
It is puzzling that Cates should have found it necessary to
promote the use of N-9 as a contraceptive, to soften the impact of the negative
results announced in Durban.
We do not know whether the US-funded trials in other African
countries represent the "more work" to which Dr Rees referred.
The gel mentioned in this article is produced by a US
company called Columbia Laboratories Inc and is marketed as Advantage-S.
According to the Wall Street Journal, after the N-9 trial results were announced
in Durban, Columbia shares 56%, to $5.75. The paper also reported that,
nevertheless, President and CEO of the company, Mr William Bologna, said the
negative N-9 results "may not be scientifically meaningful."
In a press release dated March 20, 2000, Columbia
Laboratories Inc said: "Prospective investors are cautioned that
any.(Columbia) forward looking statements are not guarantees of future
performance and involve risks and uncertainties, and that actual results may
differ materially from those projected in the forward-looking statements (of the
company). Such risks and uncertainties include, among other things, the
successful timely completion of the study now being conducted by the UNAIDS
Despite this cautionary note, Columbia Laboratories Inc
could not avoid the retribution of either the market or its shareholders.
According to the Wall Street Journal, not only did its share price fall
dramatically, but it was also sued by its shareholders. The shareholders charged
that insiders sold more than $1 million in stock at inflated prices before the
results were announced.
This is a highly disturbing story that has directly affected
us as a country. It raises a number of questions that require urgent answers,
some of which are:
- Why did the MCC approve N-9 trials knowing the toxic
effect of this compound?
- Why did Drs Karim and Rees assume the role of principal
investigator given the positions they occupied in the state medical
- What other trials related to HIV/AIDS have been and are
being carried out in our country?
- What impact have these trials had on the health of the
subjects recruited to participate in these trials?
- Why was the N-9 trial conducted only in African
countries (and Thailand) and not the United States, which also has
- What measures have been taken to care for the
prostitutes used in the trial, who suffered genital lesions and turned
HIV-positive as a result of the use of N-9?
- What measures have been taken to care for other people
whose health might have been adversely affected as a result of other
- Why did UNAIDS decide to use our people as disposable
objects who could be exposed to N-9, when UNAIDS knew that N-9 had been
proved to be toxic?
- What steps has UNAIDS taken to look after the people
whose health has been seriously undermined by its wilful activities?
- What will our government do to ensure that this serious
matter is attended to?
- Has the attention of the UN Secretary General, the UN
Security Council and the General Assembly been drawn to these UNAIDS
- What steps has UNAIDS taken to ensure that especially
the developing countries discontinue and do not allow any N-9 trials?
- What role did our Ministry and Department of Health play
in the N-9 matter?
- What role have our Ministry and Department of Health
played and are playing to ensure that ethical norms are observed in the
conduct of all drug trials in our country, and that the poverty of our
people is not exploited to test dangerous drugs here, in a manner that would
not be allowed in the developed world?
- Has the informed consent of those who have been involved
in the drug trials been obtained and what steps have been taken to ensure
that those involved are truly properly informed?
- What measures have been taken to ensure transparency and
a system of accountability with regard to the drug trials?
- Once the efficacy and safety of drugs previously tried
in South Africa has been established, and these drugs accordingly
registered, what steps have been taken to ensure that these drugs are
available at affordable prices to our people?
All these questions, bearing on the very lives of our
people, require urgent answers.
The story contained in this article speaks of our vulnerability
as an African country to the anti-human activities of some corporate forces.
It also speaks to our own capacity, as South Africans, willingly to co-operate
in the promotion of these activities. It tells a story of how easy it
is for some, further to entrench the abuse of already abused African women
- this time in the name of science and health.
Dr Rees, Chairperson of the MCC, argues that 'more work'
needs to be done on N-9 because the negative results announced in Durban 'were
not conclusive'. This sentiment is echoed by the CEO Bologna of Columbia
Laboratories Inc., who says that these negative results 'may not be
On the other hand, the CDC says: "However, given that
N-9 has now been proven ineffective against HIV transmission, the possibility of
risk, with no benefit, indicates that N-9 should not be recommended as an
effective means of HIV prevention."
What we ask is - what else about HIV/AIDS is more about
profit and less about the health of our people. Time will tell.