Kaiser Daily HIV/AIDS Report-Thu, 19 Jul 2001
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*On Eve of G8 Summit, E.U. Pledges $103.5M to Global AIDS Fund, While
Canada Announces $100M Donation
*South African Catholic Newspaper Backs Condom Use for Married
Couples
*Bristol-Myers Squibb Will Not Sue South African Generic Manufacturer
Over AIDS Drugs
*International Trials of Experimental AIDS Drug Reveal Gaps in
Regulatory Framework
Global Challenges
On Eve of G8 Summit, E.U. Pledges $103.5M to Global AIDS Fund, While
Canada Announces $100M Donation
The European Union announced yesterday that it will contribute 120
million euros (about $103.5 million) to the Global AIDS and Health
Fund, Reuters reports. The contribution will be officially announced
by European Commission President Romano Prodi at the G8 summit that
begins tomorrow in Genoa, Italy (Reuters, 7/18). Meanwhile, Canada
announced a donation to the fund of 150 million Canadian dollars
(roughly $100 million), an amount intended to be "over and above" the
270 million Canadian dollars it has already pledged independently to
fight HIV/AIDS (Reuters, 7/18). Leaders of the G8 countries -- Brit-
ain, Canada, France, Germany, Japan, Italy, Russia and the United
States -- are expected to discuss and formally "announce the outline
of the fund" during the summit's first day tomorrow. They will be
accompanied by U.N. Secretary-General Kofi Annan, who launched the
fund in April, Reuters reports. Annan has estimated that the fund
needs between $8 billion and $10 billion to effectively tackle
HIV/AIDS, malaria and tuberculosis in the developing world (Reuters,
7/18). Excluding the E.U. and Canadian donations, current contribu-
tions to the fund stand at slightly less than $1 billion and include
$200 million each from the United States, Britain and Japan; $127
million from France; $131 million from Germany; and $100 million from
the Bill and Melinda Gates foundation, as well as smaller donations
from several developing countries (AP/Las Vegas Sun, 7/18). The fund
is expected to be "fully operational" by Dec. 15, Agence France-
Presse reports (Agence France-Presse, 7/19).
Not Enough, Experts Say
Writing in the July 19th issue of the journal Nature, however, an in-
ternational group of AIDS experts says that the fund will need at
least $9 billion over the next five to 10 years to be effective,
Reuters Health reports. The group notes that current contributions
are "well below what is needed" and calls on the leaders gathered at
the G8 summit to "solidify their commitment" to the AIDS fund with
further contributions. The call "comes from our feeling that there
are moments in time when one sees hope," Yale University School of
Public Health Dean Michael Merson, one of the authors, said (Norton,
Reuters Health, 7/18). Peter Hale of the Paris-based Necker Research
Institute, another author, added, "Donor countries are fooling them-
selves if they feel that [current contributions] would make a sig-
nificant impact." He noted that the $7 billion to $10 billion truly
needed to fight HIV/AIDS is "just 0.005%" of the total gross national
product of the seven wealthiest G8 countries and is "not an unreason-
able sum to spend on the 33 million people with HIV/AIDS in Africa,
Asia and Central and South America" (Elgood, Reuters, 7/18).
South African Catholic Newspaper Backs Condom Use for Married
Couples
The Southern Cross Journal, a "leading" South African Catholic news-
paper, has asked the church to consider "relax[ing] its blanket ban"
on condom usage when the Southern African Catholic Bishops Conference
meets on July 24, BBC News reports. Editor Gunther Simmermacher,
writing in support of Bishop Kevin Dowling, who has requested that
condoms be addressed at the conference next week, said that condoms
have an "important role to play in preventing the transmission of
HIV" and should not be considered a contraceptive when being used to
"prevent against HIV infection," but should be regarded instead as a
"means of preserving human life." Simmermacher said that the paper
"only" supports the use of condoms among married couples where one
partner has HIV, adding that the "real answer" to the nation's HIV
epidemic is to "educate people to avoid promiscuous behavior." Sim-
mermacher said that the paper has received "little response" to the
editorial, but most Catholics will not see it until this coming Sun-
day when it will be available at mass. Archbishop Francisco Colacco,
the Vatican's representative in South Africa, said he does not think
the conference will endorse condom usage (Podger, BBC News, 7/17).
Drug Access
Bristol-Myers Squibb Will Not Sue South African Generic Manufacturer
Over AIDS Drugs
In a letter faxed yesterday to officials at Aspen Pharmacare Ltd.
Holdings, South Africa's largest generic drug maker, Bristol-Myers
Squibb Co. said it would not initiate a lawsuit against the company
in the next five years if it chooses to manufacture and/or sell in
sub-Saharan Africa generic copies of Bristol-Myers' antiretrovirals
Videx and Zerit, the Wall Street Journal reports. "This document is
designed to give you clear comfort that you will not be sued by us,
as set forth specifically in the Agreement, for your manufacture or
sale of the covered products in sub-Saharan Africa," the letter,
signed by Bristol-Myers Senior Manager Robert Lefebvre, said. The
proposed "immunity from suit" agreement would be renewable at Bris-
tol-Myers' "discretion" and could be voided if the drugs were ex-
ported for sale outside of sub-Saharan Africa. If the deal is ap-
proved by Aspen, it would make Bristol-Myers the first major pharma-
ceutical company to permit a generic drug maker to produce and sell a
patented drug in sub-Saharan Africa, setting a precedent that "might
broaden access to AIDS drugs" by "prompt[ing] other major drug compa-
nies to follow suit," the Journal reports.
Let's Make a Deal
In May, a South African Bristol-Myers manager was quoted by local pa-
pers as saying that the company would grant a license to produce or
manufacture Zerit and Videx, whose patents expire in 2007 and 2012
respectively, to any company that could beat the combined $1-a-day
price it had offered in March. Aspen requested such a license in a
letter dated May 31. Under Aspen's proposal, Indian generic drug
maker Hetero Drugs Ltd. would supply the raw materials necessary to
make the drugs. Bristol-Myers officials said that the local man-
ager's offer was a "misstatemen[t]" but that yesterday's proposal not
to sue was in "keeping with the commitment" to offer low-cost drugs
that the company made in March. "We went the route that allows us to
do exactly what we said we'd do. We do not feel that we want to en-
gage in a business relationship with Aspen and so we feel this re-
sponse is adequate," Lefebvre said. Aspen officials did not comment
yesterday on whether or not they will take up the offer, but previ-
ously "expressed doubts" about such an arrangement. Aspen CEO
Stephen Saad last week said, "Some other companies might be comfort-
able to proceed with a letter, but for Aspen, it is not a position we
are comfortable with." Yale University, which holds the patent on
Zerit, supports the proposal. "We are in favor of getting these
drugs out as quickly and cheaply as possible," university representa-
tive Karen Peart said (Zimmerman et al., Wall Street Journal, 7/19).
Protests by Yale students and professors were instrumental in getting
Bristol-Myers to lower the cost of the drug in March (Kaiser Daily
HIV/AIDS Report, 3/15).
Science & Medicine
International Trials of Experimental AIDS Drug Reveal Gaps in Regula-
tory Framework
Although requests to conduct clinical trials on the "experimental"
AIDS drug Virodene P058 have been turned down in a number of coun-
tries, the drug has "quietly" been tested in Tanzania "with the help
of the Tanzanian police and military," the Wall Street Journal re-
ports. Virodene, which is derived from an industrial solvent known
as dimethylformamide (DMF), has been hailed as a "potential wonder
drug" by its supporters and "vehemently" criticized as a "modern-day
snake oil that could conceivably make AIDS worse" by its opponents.
The idea to test Virodene was originally conceived by medical techni-
cian Michelle Olga Patricia Visser, who noted during laboratory tests
on animal organs that DMF can kill "some kinds of bacteria." Ques-
tioning whether the drug might also work against viruses such as HIV,
Visser organized a small study of 11 HIV-positive people in South Af-
rica. Although Visser said that the drug produced "magnificent re-
sults" in study participants, South Africa's Medicines Control Coun-
cil barred additional human trials of Virodene, stating that the sub-
stance "was potentially harmful and there was scant evidence it would
work." The council cited a 1997 study published in the journal AIDS
Research and Human Retroviruses that "suggested that DMF could actu-
ally inflame HIV." Visser and her former husband Jacques Visser left
South Africa and traveled to England to conduct a study of the drug
in 15 HIV-negative people, but the results of the tests have not yet
been published. After the England study, the Vissers went to Tanza-
nia to conduct additional human trials of Virodene. But the National
Institute of Medical Research, a "key" Tanzanian health agency, de-
nied their proposal for the tests, noting "major methodological prob-
lems which need rectification." The Vissers then contracted with the
military and police to hold a study of 64 HIV-positive people. The
trial was held in two places -- a military hospital and a medical
clinic owned by the country's inspector general of police. Jacques
Visser said that he "obtained all necessary authorization" for the
study, citing a letter written by Dr. Aaron Chiduo, who was then
serving as Tanzania's minister of health. Chiduo, however, said that
he told the trial organizers and the military to obtain approval from
the NIMR, which they failed to do. Jacques Visser, however, said
that Chiduo's "positive letter 'basically overruled'" the NIMR and
that the military "doesn't need health department approval to run
clinical trials," although the Journal states that many of the trial
participants were civilians. The Journal also reports that Michelle
Visser's "academic credentials" are in "question." She says that she
is a full professor and head of the Department of New Technologies in
Medicine at Modern University in Portugal, but the university said
there is no such department and does not have a record of Michelle
Visser on the university faculty.
Raising Ethical Questions
The case of the Virodene trials "shows how even an experimental drug
with little scientific backing can win adherents," the Wall Street
Journal reports. The Vissers say that all Virodene trials "were con-
ducted following the highest international ethical, scientific and
safety standards," but the Journal reports that much about the tests
"remains unknown." The Vissers declined to name the owner of Virod-
ene Pharmaceutical Holdings, the private, South African firm sponsor-
ing the tests. The Vissers' tests have been endorsed by "prominent"
figures such as South Africa's former Minister of Health Nkosazana
Zuma and South African President Thabo Mbeki, who was serving as dep-
uty president of South Africa at the time of the Vissers' South Afri-
can trial (Schoofs, Wall Street Journal, 7/19).
The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.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
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