AFRO-NETS> Kaiser Daily HIV/AIDS Report-Thursday 12th 2001

[Cecilia Snyder <csnyder@ccmc.org>]

Kaiser Daily HIV/AIDS Report-Thursday 12th 2001
-----------------------------------------------

*Kenyan Government Prepares Condom Policy -President Daniel Arap Moi Asks
  Citizens to Refrain From Sex for Two Years
*U.S. 'Releases' $11.5 Million in Prevention Aid to Kenya
*Uganda to Implement AIDS Project to Build Infrastructure for Drug
  Distribution
* Clinical Trials in Developing Countries Should Be Held to Ethical
  Standards, Panel Says


Global Challenges

As Kenyan Government Prepares Condom Policy, President Daniel Arap
Moi Asks Citizens to Refrain From Sex for Two Years

In three weeks, Kenya will unveil a national condom policy as
part of its HIV/AIDS prevention plan, the Daily Nation reports (Shimoli,
Daily Nation, 7/11). However, President Daniel Arap Moi is "urging"
Kenyans to abstain from sex for two years to help prevent the spread of
HIV/AIDS, saying it "embarrass[es]" him to be spending government money
on condoms. "As a president, I am shy that I am spending millions of
shillings importing those things," he told a meeting of the
Pharmaceutical Society of Kenya. Arap Moi said as president he will "do
the best I can [to combat the country's HIV/AIDS epidemic], but the
solution is to prevent, not to participate," adding that the condoms
were "essential" to fighting the disease. He asked members of the
society to help spread a "message of morality" during a month-long drug
awareness campaign to appeal to the international community for cheaper
drugs. The initiative was launched yesterday at the meeting (Omari,
Daily Nation, 7/12). Dr. Kenneth Chebet, head of the AIDS control unit
of the Ministry of Health, said Wednesday that the condom policy will
include the distribution of 300 million condoms recently purchased by
the government as part of its effort to curb HIV infections among people
between the ages of 15 and 25 by 30% over the next four years. Last
year, 10 million condoms were used by Kenyans, according to the AIDS
Control Council. The new shipment, for which the cost has not been
disclosed, will provide an average of 60 condoms for every sexually
active male over the next year. Official estimates place the current
number of HIV infections among Kenyans at 2.2 million. The
inter-ministerial committee drafting the plan, which is expected to
include guidelines for the distribution of the condoms, sought to
include religious leaders, including Catholic and Muslim leaders who
object to condom use, in order to "ensure widespread acceptability,"
Chebet said (Daily Nation, 7/11). However, religious leaders were
"swift" to oppose the plan, saying the government should be promoting
abstinence instead. "Committing adultery is against the laws of God and
importing condoms will mean that more people will be actively engaged in
sex," Catholic Archbishop of Mombasa John Njenga told the East African
Standard. Sheikh Mohamed Dor, secretary-general of the Council of Imams
and Preachers of Kenya, said the country was "committing suicide" by
offering the condoms, when he said would "encourage" young people to
engage in "premature" sex (Reuters/Contra Costa Times, 7/12).

---

Government Taking Steps to Provide Drug Access

During yesterday's meeting with the Pharmaceutical Society, Arap
Moi said the government was "taking measures" to provide infected
citizens with antiretroviral treatment and pointed to the recent passage
of the Industrial Property Bill and a "restructuring" of the country's
medical supply service as evidence of the government's resolve to
increase drug access. Public Health Minister Sam Ongeri said the
government is restructuring the national laboratory to "vet" generic
drugs in order to "ensure" their efficacy and safety. Dr. Wanjau
Mbuthia, chair of the society, also suggested the government create a
Director of Pharmacy position to "streamline" industry regulations and
recommended that parliament pass a law allowing the society to "punish
errant members." Arap Moi added that he has asked the international
community for assistance in procuring the anti-AIDS drugs (Daily Nation,
7/12).
---

U.S. 'Releases' $11.5 Million in Prevention Aid to Kenya

The East African Standard reports that the U.S. government has
given Kenya $11.5 million to devote to HIV/AIDS efforts. Peter
Claussen, a spokesperson for the U.S. embassy in Nairobi, said the money
was $3.5 million more than the amount "promised" to the government by
Secretary of State Colin Powell on his May visit to Kenya. On that
visit, Powell was "approximating" the U.S. donation, which will help
fund prevention efforts, and therefore gave a lower $8 million estimate.
The money will go to Family Health International, Impact Project and
PathFinder International among other groups (Wangusi, East African
Standard, 7/12).

Elite to Blame for Spread of AIDS?

In other Kenyan news, Central Provincial Commissioner Zachary
Ogongo yesterday told a group of American students that the country's
"elite" are responsible for the spread of HIV/AIDS in Kenya, the Daily
Nation reports. "In Kenya, HIV/AIDS started with the cream of society
acquiring it. The only message they gave to the people was 'beware
people are sick' while they were the same people who were sick," he
said. "Although the awareness is high now it is not sufficient to
change the attitude, coupled with the stigmatization of both family
members and those infected, who fail to disclose what one is suffering
from," he added. "[W]idespread" drug abuse among the country's youth,
which aids the spread of the disease, "crept" unnoticed into Kenyan
society "and the first thing was denial," he said, adding that the
government is now "admitting it is a societal problem" (Daily Nation,
7/12).

---

Drug Access

Uganda to Implement AIDS Project to Build Infrastructure for Drug
Distribution

The Uganda AIDS Commission will coordinate a five-year, $50
million project to build hospital centers and to provide antiretroviral
drugs for AIDS patients, Kyodo News reports. Uganda will contribute
$2.5 million to the project and the World Bank will fund the remainder.
All 56 national districts will be required to form HIV funding
committees to receive their share of $10 million in HIV/AIDS funds,
while $15 million will be disbursed at the community level and $20
million will be allocated to procure antiretroviral drugs, Project
Coordinator Peter Nsubuga said (Kyodo News, 7/11). The program will not
purchase the drugs, but rather build the national infrastructure and
train its health workers "to make possible the eventual use of
antiretroviral drugs," World Bank health specialist Dr. Peter Okwero
said. The Ugandan government wants to supply drugs to prevent
mother-to-child HIV transmission, but Okwero explained that Uganda needs
better infrastructure prior to plan implementation. With World Bank
reports that 80% of drugs in Uganda are stolen before they are delivered
to clinics and patients, National and District Program Coordinator
Julius Byenkya said that the project would involve "strict accounting to
prevent corruption." World Bank Health Economist Shiyan Chao
acknowledged that the programs' funds and existing available funds for
HIV/AIDS are "insufficient," but noted that if the program is
successful, "more money will come later" (Bialik, Associated Press,
7/11).

---

Science & Medicine

Clinical Trials in Developing Countries Should Be Held to Ethical
Standards, Panel Says

\When designing and conducting clinical trials of drug therapies
in developing countries, scientists should not enroll people who "would
be unable to afford" the medicines and should not give study volunteers
placebos in place of drugs "that are known to work," members of the
National Bioethics Advisory Commission write in a New England Journal of
Medicine article. Reuters/Contra Costa Times reports that the article
represents the "latest round in a debate over" the ethical questions
surrounding clinical trials in developing nations. Concern over these
studies was raised in 1997, when members of Public Citizen's Health
Research Group cited 15 government-funded studies that were testing
"various" treatments aimed at halting mother-to-child transmission of
HIV. Group members Drs. Sidney Wolfe and Peter Lurie said that these
studies -- all of which were being conducted in developing nations --
were "unethical" because some of the women enrolled in the study were
given placebos, despite the fact that AZT had been shown to prevent
vertical transmission. Distribution of a placebo in place of an
established treatment was perceived as unethical in the United States
and several other countries at the time (Emery, Reuters/Contra Costa
Times, 7/11).

---

Study Standards

In their NEJM article, Harold Shapiro and Eric Meslin, chair and
executive director of the commission, respectively, write that the
United States has developed "substantive ethical standards" for clinical
trials that include a "required set of procedures" for their
implementation. Shapiro and Meslin write that these standards were
developed on "the principles of justice and individual autonomy" and
that the standards apply to all research in the United States on human
subjects that is financed by a variety of federal agencies or regulated
by the FDA. This system has "worked reasonably well for clinical
research in the United States" and the same standards should be applied
to all clinical trials conducted abroad, they add. They write that
clinical trials conducted at home and abroad should not "exploit" study
participants, should include prior review and approval by ethics review
committees, should "minimiz[e]" the risk to participants, should present
a "favorable risk-benefit ratio" to participants and should require
informed consent from "all competent adult participants." Participants
also should receive "adequate medical care" during the trial, Shapiro
and Meslin state, adding that although these provisions are not required
in the United States, they could be adopted separately by developing
countries. However, the authors state that one "important" standard is
a requirement that clinical trials sponsored or regulated by U.S. groups
be "responsive to the host country's health needs" and not conduct tests
of drugs in countries that cannot afford them. "If the intervention
being tested is not likely to be affordable in the host country or if
the health care infrastructure cannot support its proper distribution
and use, it is unethical to ask persons in that country to participate
in the research, since they will not enjoy any of its potential
benefits," they write. Thus ethics review panels and researchers will
have to decide if a trial in another country is "justifiable."
Justifiable studies could include research addressing an "important
health problem" in the country where the trial is being conducted,
trials that are a joint effort by the country sponsoring the study and
the host country and studies that address important health problems
occurring in both the sponsoring and host countries.

Placebos

Shapiro and Meslin write that clinical trials involving
treatment for a "life-threatening" disease for which "an established,
effective treatment is available" should not use a placebo control
group. "Moreover, such a trial is not ethical if patients in the
developed country would be the primary beneficiaries and if it is not
clear that the trial would be responsive to the health care needs of the
host country," they state. The authors add that trial sponsors have an
"ethical obligation" to make any treatments found to be successful
during the trial available to participants after the study's conclusion.
"There is a related obligation to ensure that participants are no worse
off during the trial than they were before it," they write, adding that
participants should not suffer after the trial as a result of not being
able to access the drugs they were given during the study
(Shapiro/Meslin, NEJM, 7/12).

---

The Kaiser Daily HIV/AIDS Report is published for kaiser network.org, a
free service of The Henry J. Kaiser Family Foundation, by National
Journal Group Inc.c 2001 by National Journal Group Inc. and Kaiser Family
Foundation. All rights reserved.
Contact Daily Reports Staff Editorial
Tel: +1-202-672-5952
Fax: +1-202-672-5767
mailto:dailyreports@kaisernetwork.org


--
Send mail for the `AFRO-NETS' conference to `<afro-nets@usa.healthnet.org>'.
Mail administrative requests to `<majordomo@usa.healthnet.org>'.
For additional assistance, send mail to:  `<owner-afro-nets@usa.healthnet.org>'.