AFRO-NETS> Kaiser Daily HIV/AIDS Report- Wed, 14 Mar 2001

[Cecilia Snyder <csnyder@ccmc.org>]

Kaiser Daily HIV/AIDS Report- Wed, 14 Mar 2001
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DRUG ACCESS 

1. South Africa Will Not Declare AIDS National Emergency

The South African government announced yesterday that it will not de-
clare HIV/AIDS a national emergency, a move that under World Trade 
Organization rules would have allowed the country to import generic 
drugs "regardless of objections from drug firms claiming abuse of 
patent rights," Reuters reports (Reuters, 3/13). 

South African President Thabo Mbeki in Parliament today called the 
move "not necessary." Speaking in response to a question posed by op-
position leader Tony Leon, Mbeki said, "Declaring a national emer-
gency for the simple reason of accessing any drug sends a signal that 
tends to narrow the response to AIDS to the issue of one particular 
set of drugs" (Lovell, Reuters, 3/14). He added that the move would 
have "other complex consequences for the country, which are undesir-
able, especially where there are other ways to achieve the same ob-
jective -- that is obtaining affordable access to all medicines" 
(Cohen, Associated Press, 3/14). 

The decision "commits" the government to fight a lawsuit brought by 
39 pharmaceutical companies, represented by the Pharmaceutical Manu-
facturers Association of South Africa, that seeks to block the Medi-
cines Control Act that would allow the government to import or manu-
facture cheaper generic AIDS drugs. The drug companies argue that the 
law violates international trade law and infringes on their patent 
protections. The case has been postponed until April 18 to allow AIDS 
advocates and the drug companies time to prepare testimony. "(Calls 
for an emergency) seem calculated to divert attention from the gov-
ernment's defense, through the courts, of our people's basic right to 
affordable drugs," Health Minister Manto Tshabalala-Msimang said yes-
terday (Reuters, 3/13). 

Mbeki dismissed arguments that the government's refusal to declare a 
state of emergency indicated a lack of government commitment to 
fighting the disease. "I see no reason not to rely on the comprehen-
sive legislation approved by this house and now before the courts. 
... There is no basis for asserting that the government is not taking 
this seriously" (Reuters, 3/14). 

Leon argued, "Last year an estimated 250,000 South Africans died of 
AIDS. It is estimated that more than four million South Africans are 
sick or dying of AIDS at the moment and if that isn't an emergency, 
it is difficult to know what is" (Associated Press, 3/14).


2. Newsweek Investigates Who 'Pays for AIDS'

"Big Pharma has a big problem," Newsweek/MSNBC.com reports in its 
online March 19 issue, referring to growing concerns that the pharma-
ceutical industry is more interested in turning a profit than in sup-
plying its much-needed HIV medicines to developing countries. As drug 
firms developed better -- and more expensive -- antiretroviral medi-
cations over the last decade, the developing world, home to 95% of 
the world's HIV cases, was "shut out" (Power, Newsweek/MSNBC.com, 
3/19). Only a "tiny minority" of HIV-positive Africans are able to 
pay for private AIDS therapy, and "even fewer get it for free," but 
"those numbers are jumping as the prices for trademarked retroviral 
drugs collapse" (Masland, Newsweek/MSNBC.com, 3/19). 

The pharmaceutical industry has been responding to increasing opposi-
tion to the high cost of AIDS drugs by significantly reducing prices 
in Africa and other poor regions, despite its worries that "the poor 
don't have enough money to afford even cheap drugs." In an address to 
the entire company, GlaxoSmithKline CEO Jean-Pierre Garnier said, "I 
don't want to be the CEO of a company that only caters to the rich. 
... I want those medicines in the hands of many more people who need 
them." GSK, holder of the "largest arsenal of AIDS drugs," is strug-
gling to devise a business model that will permit the firm to in-
crease drug access to the poor and sick, while concurrently yielding 
a profit and ensuring the investment of millions in research and de-
velopment, Garnier said. 

But the drug industry faces considerable challenges, including the 
fact that many developing nations do not have the physicians needed 
to administer the complicated drug regimes and fears that discounted 
drugs will "make their way back to higher-priced markets through back 
channels," with Westerners also demanding lower prices. "The devel-
oped world must be willing to pay reasonable prices for medicines in 
order to cover costs for developing countries. Essentially we must be 
allowed to generate revenue for R&D in Europe, the United States and 
Japan, while transferring the benefit of this research, basically for 
free, to the developing world," Garnier wrote to European Commission 
President Romano Prodi last fall. Drug companies argue that the cur-
rent protests against them "cloud the core issue: a lack of aid from 
the North to buy drugs."


On Patents and Pricing

Vikki Ehrich, head of GSK's external relations for HIV/AIDS, said 
that the current lawsuit the drug company has filed with 38 others 
against a South African law that would permit the importation and 
manufacture of cheaper drugs, is "not about health," but about a 
"vague law on patents," adding, "Patents do not block access to medi-
cines." Instead, she said, blocked access can be blamed on a "lack of 
political will and health care infrastructure in AIDS-devastated 
countries." 

But Toby Kasper, coordinator of the Access to Essential Medicines 
Campaign for Doctors Without Borders in South Africa, said that drug 
companies "make a lot of noise about wanting to improve access to 
medicines. Now here's a chance for them to do something about it, and 
they're suing to block it." 

In 1997, when "tiered pricing was still considered blasphemy," Glaxo 
Wellcome (which recently merged with SmithKline Beecham to form GSK) 
HIV Manager Peter Young argued that it was ethically wrong for drugs 
to be priced out of the reach of those who need the treatments the 
most. Glaxo local managers were permitted to cut prices for the com-
bination drug Combivir, "with the idea that increased volume would 
compensate for lower prices." However, this system "didn't work," and 
local managers feared financial losses. GSK is currently working on a 
plan due in June that would provide managers with an incentive to re-
duce prices. But "changing from a company that sells a few pills at 
high prices in the developing world to one that sells high volumes to 
the masses will require a revolution in the corporate culture," News-
week/MSNBC.com reports. 

Last May, GSK joined a U.N. initiative to sell Combivir in developing 
countries for only $2 per day, a price company spokesperson Philip 
Thomson calls "sustainable ... for now" (Power, Newsweek/MSNBC.com, 
3/19). Kasper welcomes such price reductions, saying they help Africa 
"move to a place where Africans can talk about AIDS as a chronic con-
dition." Doctors Without Borders Mission Director for Kenya Jean Luc 
Anglade agreed, "This is the first time I'm confident that we will be 
able to start (dispensing drugs) soon. The numbers will depend on how 
cheap the drugs will become" (Masland, Newsweek/MSNBC.com, 3/19). 
Newsweek/MSNBC.com concludes that the pharmaceutical companies' "de 
facto surrender to tiered pricing may ease the war against them. But 
will it alleviate the AIDS crisis?" (Power, NewsweekMSNBC.com, 3/19). 


GLOBAL CHALLENGES

3. Weakened Live-Virus HIV Vaccine Could Raise Death Rates in Less-
Affected Countries

The use of an attenuated live-virus HIV vaccine may "greatly" de-
crease mortality in countries with a high AIDS rate, but could actu-
ally increase death rates in countries where the AIDS epidemic is 
"low or moderate," according to a "sophisticated mathematical model" 
created by a research team at the University of California-Los Ange-
les. A vaccine using a weakened strain of live HIV could be "instru-
mental" in fighting AIDS as the vaccine may generate strong immunity, 
but it could also cause the disease in some vaccinated people, creat-
ing a medical "Catch-22" situation, Reuters Health reports. 

The researchers used the current AIDS death rates in Zimbabwe, where 
25% of the population is infected with HIV, and Thailand, where only 
2% of the population is infected. The study found that a live-virus 
vaccine would eliminate naturally occurring strains of HIV in both 
countries within 50 years, but would cause more than 5% of the popu-
lation in Thailand to develop AIDS over 25 years. In Zimbabwe, the 
researchers predicted that more people would die of AIDS without a 
vaccine than with a public vaccination effort using live HIV. "The 
vaccines have the potential to do a great deal of good, but they also 
have the potential to do harm," lead researcher Dr. Sally Blower 
said, adding, "You can develop very effective vaccines. But they may 
well be the ones that are the least safe. There may be a trade-off 
that people will have to consider between efficacy and safety once 
these vaccines have been developed." To not use such a potent vaccine 
could mean "letting the entire continent of Africa be totally de-
stroyed," she said, but asked, "Should you kill some people for the 
greater good of the rest of the people? That is a huge, huge ethical 
debate." 

The study, published in the Proceedings of the National Academy of 
Sciences, did not advocate vaccine use, but served to "provide a 
theoretical framework for predicting the outcome of using 1,000 dif-
ferent potential versions of such a vaccine," Blower explained 
(Dunham, Reuters Health, 3/13). Because of the risks, live-virus vac-
cines currently would not be approved for use by regulatory agencies, 
but contributing researcher Professor John Mills of Melbourne, Aus-
tralia's Macfarlane Burnet Center said the study results show that 
live attenuated HIV vaccines "should be pursued as a means of glob-
ally eradicating HIV," despite the risks. He added that it was likely 
that the vaccines would provide the most benefit in countries where 
the prevalence of HIV was greater than 10% (Fannin, The Age, 3/14). 


4. AIDS Vaccine Development Not Targeting Common African HIV Strain, 
Harvard Expert Says

AIDS vaccine trials are "failing to address the needs of millions of 
Africans at risk for the disease," Dr. Seyou Ayehunie of Harvard Uni-
versity said at a U.N. panel discussion sponsored by WHO and the In-
ternational Health Awareness network, according to a U.N. release. 
Ayehunie stressed that in order to "fully understand the spread of 
AIDS in Africa in all its dimensions," it is critical to understand 
the prevalent strains of HIV. Of the several subtypes of HIV in Af-
rica, subtype C is the "most fierce by far," causing 90% of all in-
fections in Africa and 75% of infections worldwide. But the subtype 
is only represented in 5% of vaccine trials, Ayehunie pointed out 
(U.N. release, 3/12).


5. South African Vaccine 'Steams Ahead' 

Meanwhile, the South African HIV Vaccine Action Campaign has com-
pleted laboratory research on a potential vaccine, and human trials 
are expected to start in the third quarter of the year, according to 
Health-e. Project Manager Zo Mbelle described the process as "very, 
very exciting," saying that the trial "will put South Africa on the 
map, and show that we have the capacity to develop our own vaccine, 
unlike many other African countries who have depended on scientists 
from Europe and the United States". 

Medical Research Council spokesperson Michelle Galloway added, "Dr. 
Carolyn Williamson of the University of Cape Town and Lynn Morris of 
the National Institute of Virology have been collaborating with Al-
phavax, based at the University of North Carolina, to produce a South 
African-based vaccine utilizing the Venezuelan encephalitis virus." 
According to Williamson, the VEE has been manipulated to act as a 
"delivery system" for HIV genetic material. The vaccine "enters the 
cells and makes copies of itself, which results in the production of 
large amounts of HIV protein. The body identifies these proteins as 
foreign and makes a strong immune response against them," she added. 
Williamson called it a "dummy run" for real HIV infection. 

Human trials will be conducted at the R.K. Khan Hospital in Durban. 
Alphavax has also been working on a similar vaccine for HIV subtype B 
in the United States, and currently 10 other candidate vaccines are 
being developed in South Africa. Last week, Kenya launched the conti-
nent's first human trial of an HIV vaccine, but it is based on HIV 
subtype A, the most common form of the disease in East Africa 
(Cullinan, Health-e, 3/8).


OPINION 
6. South African Ambassador Issues Statement Defending South Africa 
in Patent Lawsuit

Responding to the pledges of Doctors Without Borders, ACT UP and Ox-
fam to support the South African government in the trial over the 
country's 1997 Medicines and Related Substances Act, South African 
Ambassador to the United States Sheila Sisulu issued a statement de-
claring that the South African government is prepared to use "all 
available channels," including the court system, to protect its ef-
forts to provide access to cheaper AIDS drugs. Sisulu explained that 
the act -- which allows the country to access cheaper drugs through 
parallel importing and compulsory licensing -- is a "critical instru-
ment" in correcting South Africa's "highly inequitable health care 
system," as it grants health services to a greater section of the 
population. She said that South Africa plans to execute this task "in 
a manner which is consistent with our international commitments that 
fully protect intellectual property rights." Sisulu concluded, "Our 
objectives in terms of the Medicines Act are really no different from 
what is already possible in many developed countries, including the 
United States, Canada and Europe" (South African Embassy release, 
3/12).


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Cecilia Snyder
mailto:csnyder@ccmc.org

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