Kaiser Daily HIV/AIDS Report - Fri, 25 May 2001
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* Powell Meets With Mbeki, AIDS Not Discussed
* GlaxoSmithKline Announces Further Antiretroviral Price Cuts in
Kenya
* Uganda to Offer Free Antiretroviral Drugs to Pregnant Women to Pre-
vent Vertical HIV Transmission
* As First Phase of Kenyan Vaccine Trial Ends, 'Key' Scientist Re-
signs
* Breastfeeding May Increase Maternal Mortality Among HIV-Positive
Women, Study Shows
--
Powell Meets With Mbeki, AIDS Not Discussed
On the second stop of his four-nation African tour, Secretary of
State Colin Powell met yesterday with South African President Thabo
Mbeki, but they did not discuss the HIV/AIDS epidemic, which affects
an estimated 20% of the country's adult population, the Washington
Post reports. After the hour-long meeting in Pretoria, Powell told
reporters that he "didn't have to discuss" HIV/AIDS because Mbeki is
"fully seized with the problem, doing everything possible" (Jeter,
Washington Post, 5/25). Mbeki "caused a storm" last year when he com-
missioned a panel of scientists to investigate whether HIV truly
causes AIDS, a theory "long accepted as fact" by most researchers.
Last month, he again caused a stir when he questioned the need for
HIV testing because he said scientists "disagreed on what was being
tested" (AP/Richmond Times-Dispatch, 5/25). U.S. officials have taken
"pains not to openly criticize" Mbeki, however Andrew Natsios, the
new head of the U.S. Agency for International Development who is
traveling with Powell, acknowledged that Mbeki maintains some "unor-
thodox views" on HIV/AIDS. He added that Mbeki is now "cooperative"
but "implied" that his earlier hesitation to "publicly explain that
sexual intercourse spreads AIDS" enabled the country's infection rate
to climb (Barber, Washington Times, 5/25). Natsios also "suggested"
that Mbeki and other African leaders have "sometimes shirked their
duty to promote safer sex." Natsios added, "What would make a differ-
ence is any head of state -- not just President Mbeki -- publicly
saying that we have a crisis, that we need people to change their be-
havior" (Phillips, Wall Street Journal, 5/25). Natsios said that
there is a "direct connection between the willingness" of leaders to
discuss HIV/AIDS prevention and the "success of such programs" in Af-
rica and urged leaders to "speak out more forcefully" about the
causes of AIDS and methods to prevent HIV transmission (AP/Richmond
Times-Dispatch, 5/25).
Prevention is the 'Key'
South African Foreign Minister Nkosazana Dlamini Zuma, who also met
with Powell, did discuss the nation's HIV/AIDS epidemic. Responding
to criticism about South Africa's reluctance to provide antiretrovi-
ral drugs to pregnant women to decrease the rate of vertical trans-
mission, she stressed that the "most important tools" for fighting
the disease are education and medication to treat opportunistic in-
fections in AIDS patients. Powell agreed, calling prevention "the key
to it all." He added that the country needs to educate youth about
HIV/AIDS in order to "break the chain" of infection. Powell also said
he would "like to see even more" money, above the United State's $200
million contribution to the proposed global AIDS fund, go toward
fighting HIV/AIDS in Africa (Agence France-Presse, 5/25).
Plan to Involve Religious Leaders in Fight Against HIV/AIDS
Natsios announced a new international plan to involve Christian and
Muslim religious leaders in the fight against HIV/AIDS through
"preaching" abstinence and monogamy. Through the program, literature
promoting abstinence will be distributed at religious services to
"supplement" existing U.S.-funded condom-based programs. "Condoms
don't always work -- the best thing to do is behave yourself,"
Natsios said. The administration has indicated an intention to nomi-
nate condom opponent John Klink, an adviser to the Vatican and a for-
mer Catholic Relief Services official, to head the State Department
office in charge of refugee- and population-related issues. Powell
has been rumored to disagree with the choice of Klink, but State De-
partment spokesperson Richard Boucher said Powell thinks Klink is
"excellently qualified" for the post (Wall Street Journal, 5/25).
Bush 'Very, Very Interested' in Powell's Report
"Conscious of the criticism that the Bush administration is indiffer-
ent to Africa," Powell assured reporters that the president is "very,
very interested in what my report will be when I get back," the Post
states. Mbeki, who visited Bush in Texas during the campaign and is
scheduled to visit Washington next month, said that he was "certain"
that the current administration would be "as concerned" with African
matters as its predecessor was, and added that "President Bush is in-
deed very concerned that the United States must lend its strength to
help us find solutions" (Washington Post, 5/25). Powell will visit an
AIDS project in the township of Soweto and give a speech at the Uni-
versity of Witwatersrand before departing for Kenya tomorrow (de Roc-
quefeuil/Hennop, Agence-France Presse, 5/25).
--
GlaxoSmithKline Announces Further Antiretroviral Price Cuts in Kenya
Pharmaceutical company GlaxoSmithKline announced on Thursday that it
will "further slash" prices of its antiretroviral drugs in Kenya,
Reuters reports. The announcement comes as the Kenyan parliament pre-
pares to vote on legislation that would allow the country to import
and manufacture cheaper generic HIV/AIDS medications (Reuters, 5/24).
Some AIDS advocates have expressed concern that the pharmaceutical
industry might try to influence lawmakers to kill or amend the bill.
Earlier this month, GSK Commercial Director William Kiarie said that
the company accepts Kenya's proposal but is "concerned about proce-
dures for implementing it" (Kaiser Daily HIV/AIDS Report, 5/11). How-
ever, with only 1,000 of Kenya's estimated 2.2 million HIV-positive
citizens able to afford the medications, Kiarie said, "We are going
to make our products cheaper. ... We are going to increase the number
[of treated HIV-positive individuals] from the truly miserable 1,000
number we have now ... by bringing prices down" (Reuters, 5/24). The
drugs will be made available to the government, aid organizations and
large employee health programs and will be offered at a "no-profit
price." Kiarie refused to discuss specific drugs and their prices.
Indra Van Gisbergen, a lawyer working with the Kenyan Coalition for
Access to Essential Medicines, said that the announcement, which she
said was "nothing that hadn't been promised" before, was timed to in-
fluence the bill that would allow the importation or manufacture of
cheaper generic drugs. "This announcement should not be used as an
excuse not to pass the bill and allow generic drugs into Kenya," Van
Gisbergen said (Tomlinson, Associated Press, 5/25).
--
Uganda to Offer Free Antiretroviral Drugs to Pregnant Women to Pre-
vent Vertical HIV Transmission
Uganda will offer free AIDS drugs to prevent mother-to-child trans-
mission of HIV through a voluntary counseling and testing program ex-
pected to be operating throughout the country by the end of 2002,
Reuters reports. A "limited" program providing 700 mothers in Kampala
with free treatment began in April 2000, and that number is expected
to double a year from now. Dr. Iyorlumun Uhaa, director of the United
Nations Children's Fund health and nutrition program in Uganda, said,
"The expansion will require a lot of logistics -- testing, counseling
and infrastructure. But by the end of next year, we should be able to
provide the service all over the country." Johns Hopkins University
researcher Laura Guay added, "Currently we are already working out of
five sites which will quickly expand to 11 sites over the next year."
Last July, Guay and Ugandan scientists announced that nevirapine had
been clinically proven to decrease the risk of vertical HIV transmis-
sion by up to 50%. The full nevirapine regimen, which is a single
dose to the woman in labor and a single dose to the newborn within 72
hours of delivery, costs less than $4, compared to $800 for similar
preventive therapy with AZT. Uhaa said, "Currently we are administer-
ing AZT to mothers in all but one of our sites. But the plan is to
move towards the cheaper and easier-to-administer nevirapine at all
our sites." As the result of government efforts, the HIV infection
rate among pregnant women is 20%, down from 33% in 1991 (Busharizi,
Reuters, 5/24).
--
As First Phase of Kenyan Vaccine Trial Ends, 'Key' Scientist Resigns
Following the completion of the first sub-phase of a Kenyan test of a
naked DNA HIV vaccine, Dr. Ephantus Njagi, a "key" trial physician
trained to "particularly administer" the vaccine and monitor patient
reaction, resigned, Kenya's Daily Nation reports. In two weeks, after
completion of the first stage, involving 18 volunteers who experi-
enced "no serious side effects," the vaccine trial is supposed to
move into the second stage, which will test the safety and production
of killer T-cells produced in response to the vaccine. Three addi-
tional volunteers have been recruited for the second phase. Njagi's
departure has raised "new worries" over the trials, although Program
Manager Dr. Omu Anzala "insist[ed]" that the trials will proceed as
planned. "I am now doing what is necessary, as I have always been
there as a back-up to Dr. Njagi. As a program manager, I am supposed
to be on top of everything. We are however going to train someone
else to perform his job," Anzala added. Observers said that if the
study was a double blind trial, in which neither the clinical staff
nor the patients know which patients receive the vaccine and which
receive a placebo, it may be "unethical" for another researcher to
take Njagi's place.
What Sparked the Resignation?
Njagi declined to comment on his reasons for leaving the trial, but
observers speculated that it may have something to do with "interfer-
ence" by the International AIDS Vaccine Initiative, which some claim
is acting as both "financier and implementer" of the trials, a poten-
tial conflict of interest. Sources say IAVI has "attached" someone to
the study site at Kenyatta National Hospital and that person is
"tak[ing] part" in the study. Sources also speculate that "profes-
sional differences and a lack of administrative support" from the
Kenyan AIDS Vaccine Initiative could be to blame for Njagi's depar-
ture.
'Impressive' Number of Volunteers
Researchers at the trial site are "upbeat" about volunteer turnout,
which Anzala described as "extremely impressive." Because of a "pat-
ent tussle" prior to the beginning of the trials, researchers were
"apprehensive" that potential volunteers would "recoil," Anzala said,
adding "emphatic[ally]" that no money was used to entice volunteers
to take part in the study, as the only funds provided to volunteers
were for transportation. Results of the first phase are not yet ready
because volunteers must be checked eight times over 189 days. Results
are expected by the end of the year (Okwemba, Kenyan Daily Nation,
5/24).
--
Breastfeeding May Increase Maternal Mortality Among HIV-Positive
Women, Study Shows
A randomized study of HIV-positive Kenyan women with infants, appear-
ing in the current issue of the Lancet, found that breastfeeding may
raise the risk of maternal and infant death, even after controlling
for infant death from HIV infection. Researchers from the University
of Nairobi and the University of Washington from November 1992 to Oc-
tober 1997 recruited 425 HIV-positive pregnant women from four Nai-
robi city council clinics and, at 32 weeks gestation, randomly di-
vided them into two groups, directing 212 to breastfeed and 213 to
formula feed their infants. The women were counseled "with respect to
optimum feeding practices" and followed up every month for the first
year after delivery and then quarterly during the second year, until
death or the end of the study. Hospital records or reports from rela-
tives were used to determine cause of death for those who passed away
during the study. The study was monitored by a data and safety board.
Results
Of the women in the breastfeeding group, eight were lost to follow-up
before delivery, one died during pregnancy and six had "no vital
status information" post-delivery, leaving a total of 197 in the mor-
tality analysis. Thirty-nine of those women were lost to follow-up,
and 18 died during the follow-up period. Of the women using formula,
33 were lost to follow-up, and six died during the follow-up period.
The relative risk of death for breastfeeding mothers versus formula-
feeding mothers was 3.2, and the "attributable risk" of maternal
death due to breastfeeding was 69%. The difference in mortality rates
was "significant" as early as six months post-delivery. Infants of
HIV-positive women who died also showed an eight-fold increase in the
likelihood of death, even after controlling for HIV infection status.
Reasons for the Increased Mortality Rate
The researchers speculated that the "combined metabolic burdens" of
HIV and breastfeeding among women with "substantial nutritional im-
pairment" may cause an increased amount of weight loss and maternal
depletion syndrome, in which women do not replenish the vital nutri-
ents lost during pregnancy and breastfeeding. The researchers also
said that the lactation-related rise in the immunomodulating hormone
prolactin may cause immunosuppression, leaving the women more vulner-
able to AIDS-related infections. These findings "warran[t] assess-
ment," the authors state. "Our aim should be to ensure that all HIV-1
infected mothers are able to feed their infants in a way that keeps
risk to a minimum for both mother and child," they conclude (Nduati
et al., Lancet, 5/26).
More Research Needed
In an accompanying op-ed, Marie-Louise Newell of the Institute of
Child Health in London, writes that further research on the link be-
tween breastfeeding and maternal mortality is necessary because the
new findings are "not in keeping" with the results of a study con-
ducted in Durban, South Africa. That study found "no evidence of an
association between clinical problems in the mother and duration of
breastfeeding," she states. In that study, two of the 410 women who
exclusively breastfed died, while three of the 156 women who used
formula died. Newell also points out that in the Kenyan group, the
rate of intrauterine HIV transmission was higher among the breast-
feeding group, which may indicate that they were already in a "more
advanced" stage of the disease than the women in the other group
(Newell, Lancet, 5/26).
WHO Breastfeeding Recommendations
The study results come on the heels of a World Health Assembly reso-
lution on breastmilk substitutes adopted at the World Health Organi-
zation body's recent meeting in Geneva. The resolution calls on mem-
ber nations to "protect, promote and support exclusive breastfeeding
for six months as a global public health recommendation, and to pro-
vide safe and appropriate complementary foods, with continued breast-
feeding, for up to two years of age or beyond." The resolution also
called for continued "independent research" on the risk of HIV trans-
mission through breastfeeding (WHA release, 5/22).
--
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