AFRO-NETS> The Parliament of Kenya allows the purchase of cheap AIDS drugs

[Christian Labadie <CLabadie@t-online.de>]

The Parliament of Kenya allows the purchase of cheap AIDS drugs
---------------------------------------------------------------

NAIROBI, June 12 (AFP) - 18h51

The Kenyan Parliament adopted on Tuesday a bill allowing the govern-
ment to circumvent the patents of the pharmaceutical companies to 
provide cheaper AIDS drugs to the 2.2 million persons carrying the 
virus [in Kenya]. 

Kenya becomes the second country in Africa after South Africa to 
authorise in its legislation the recourse to generic copies of drug 
products still under patent.

The Kenyan law presented by the government and supported by the oppo-
sition, was adopted by an unanimous acclamation of the deputies pre-
sent after two hours of debate, noted a journalist of the AFP [Agence 
France Presse].

After this vote, technical aspects will have to be re-examined by 
parliamentary committees, then it will be represented for a final 
vote.

AIDS, which affects 2.2 million Kenyans, that is 14 % of the adult 
population according to official statistics, was declared a "national 
urgency" by the Kenyan president Daniel arap Moi in 1999.

The project, which aims at putting Kenya in conformity with the pro-
visions of the World Health Organisation (WHO), allows the govern-
ment, in the event of a "national catastrophe", to seek drugs less 
expensive than those proposed by the companies holders of patents.

It endorses several provisions of the agreements on the intellectual 
property related to trade (TRIPS), in particular [Note: numbering 
added for clarity]:

[i] the parallel import which makes it possible for a country to buy 
a patented product in a country where it is sold cheaper [than] by 
the holder of the patent,

[ii] the compulsory licensing which allows to manufacture or to im-
port some generic copies of drugs, and

[iii] "the Bolar exception" which allows a local company to prepare 
the marketing of a generic product several years before the expire of 
a patent, in order to be ready to put it on the market as soon as 
possible.

The cost of the anti-retroviral drugs (ARV), which makes it possible 
to slow down the development of the disease and to improve the dura-
tion and quality of life of the patients, "is beyond the ordinary 
possibilities of Kenyans", indicated the Minister for Health Sam On-
geri.

The combination of three drugs commonly used, costs between 2.5 and 5 
dollars per day, whereas the average income of Kenyans does not ex-
ceed a dollar per day, he declared. "If the government wanted to as-
sume the cost of it, that would total to 12 billion shillings (173 
million US dollars), whereas the total budget of the ministry for 
Health is only 9 billion shillings", he added.

"The law such as it is presented is in conformity with the interna-
tional practices and in agreement with the WTO", ensured the Minister 
of Industry Nicholas Biwott to the deputies. "The earlier it will be 
adopted, the better that will be for the people who suffer from 
AIDS."

39 pharmaceutical companies had taken the South-African government to 
court, because of a South-African law going back to 1998 allowing the 
importation of generic drugs, but they recently gave up their law-
suit following a campaign carried out by NGOs and groups of AIDS pa-
tients [Note: among others the TAC present in court, 
http://www.tac.org.za].

Several opposition deputies, while supporting the bill, asked that 
the government ensures itself of the quality of the imported drugs 
and develops the training of the doctors and the capacities of caring 
for the patients, particularly in order to avoid developing resis-
tances to the drugs with badly managed or badly controlled processing 
[Note: see below a note reproduced from AF-AIDS on a related issue].

An Nairobi orphanage began on Tuesday to distribute, for the first 
time, a generic anti-retroviral drug given by Brazil to Kenyan chil-
dren carrying the virus of the AIDS.

Source: 
http://www.healthnet.org/programs/e-med-hma/e-med.200106/msg00030.html

[reproduced with thanks to Carinne Bruneton of E-MED, and translated 
under 'fair use' by C. Labadie
mailto:CLabadie@t-online.de ]

------------
RE: Implications of the New Global AIDS Fund - Treatment Issues

[reproduced with thanks from AF-AIDS]
Source: http://www.hivnet.ch:8000/africa/af-aids/viewR?1078

In posting 1069, [...] writes:
(snip) 
It seems that the treatments available for those with AIDS are very 
complicated, expensive and have side effects that many cannot manage. 
Providing these medicines at a lower cost to Africa sounds good but 
the health care systems do not have the capacity to manage such pro-
grams. (end snip) 

R. Jeffries replies: 
If the author wishes to make a judgement about the value of antiret-
roviral treatment in Africa (and it appears that he does for some 
reason), I strongly suggest that he make an effort to find out what 
treatment *really* involves as opposed to what it "seems" to involve. 

First line regimes now involve as few as 1-3 pills taken morning and 
night (twice daily) and can provide prolonged health benefits even if 
not used continuously. For example, a recent study (below) shows that 
an antiretroviral treatment-related increase in T-cell counts to over 
600 takes an average of *two years* to decline to less than 250 (the 
danger zone for infections) *after* treatment is stopped. Dr. Paul 
Farmer, who has for some time been running a treatment program in 
Haiti, has seen responses wherein previously hospitalized mothers 
have been able to return to work and begin caring for their kids 
again - this echoes the experiences in the US showing that antiretro-
viral treatment does a good deal more than prolong illness. 

The most complicated regimens being used in the US are almost exclu-
sively for people with a long history of antiretroviral treatment and 
resistance to many of the drugs. In places like Haiti and Africa 
where virtually no antiretrovirals have been available, this type of 
treatment history does not exist. This likely explains Paul Farmer's 
observation that the success rate for antiretroviral treatment in his 
Haiti program is higher than reported for clinics in the US. 

In conclusion: - The assumption that antiretroviral treatment cannot 
lead to a return to health is incorrect - The oft-repeated assumption 
that antiretroviral treatment has to be taken "for life" to produce a 
return to health is incorrect (although larger studies are needed to 
show the minimum amount of therapy that produces the maximum benefit, 
and it's scandalous that these studies have not been conducted since 
the rationale for this approach has been clear for years - unfortu-
nately, pulsed treatment = less pharmaceutical industry profit and 
hence the studies have not been done) - The assumption that all anti-
retroviral treatments are complex is incorrect 

Richard Jefferys 
E-mail: rjefferys@hotmail.com

--
[Source:] 8th Conference on Retroviruses and Opportunistic Infections

355 -- CD4 Decay after Discontinuation of Virologically Successful 
Antiretroviral Therapy.

P .Tebas*(1), K. Henry(2), K. Mondy(1), S. Deeks(3), J. Barbour(3), 
C. Cohen(4), and W. Powderly(1).

(1) Washington Univ. Sch. of Med., St. Louis, MO; 
(2) Regions Hosp., St. Paul, MN; 
(3) Univ. of California, San Francisco; and Harvard Med. Sch., Bos-
    ton, MA. 

Background: 
CD4-driven "pulse" therapy (initiation and discontinuation of anti-
retroviral therapy at specific CD4+cell thresholds) has been proposed 
as an alternative strategy to the current virologically driven para-
digm of HIV treatment. There is little available data about rate of 
decline of CD4 cells after discontinuation of therapy in patients who 
stop therapy with an undetectable viral load. 

Methods: 
We looked at the rate of decay of the CD4 cell count in patients who 
discontinued antiretroviral therapy for at least 20 weeks after being 
fully suppressed with potent antiretroviral therapy, in two clinical 
practices. 

Results: 
31 subjects were identified (43% males, 40% white, 32+2 yr of age). 
The most frequent reasons for discontinuation of therapy were patient 
preference in 56% (most frequently in females in the post-partum), 
and drug toxicity (43%). The median nadir CD4 (before therapy) was 
383 cells/mm3 (interquartile range, IQR 244 588) and the baseline VL 
was 29,845 HIV RNA copies/ml. Patients gained on therapy an average 
202+32 CD4 cells. The median time with an undetectable VL before 
stopping therapy was 19 weeks (IQR, 9 38 weeks). The median CD4 cell 
count at stop was 635 cells/mm3(IQR 355 832). The mean follow-up af-
ter discontinuation of therapy was 50 weeks (range 20 to 119 weeks). 
Mean CD4 decay was 16+4 cells/month. The slope of the CD4 decay in-
versely correlated with the magnitude of change of CD4 on therapy (r 
= -0.527, p = 0.008) but did not correlate with nadir CD4 cell count, 
baseline viral load, type of potent antiretroviral regimen (PI based 
vs others), CD4 at the time of stop or gender. No patient developed 
an AIDS-defining event during follow-up. Two patients restarted ther-
apy and reached an undetectable viral load again. 

Conclusions: 
In this retrospective cohort of patients, discontinuation of therapy 
while fully suppressed was clinically safe. The predicted average 
time to reach a CD4 count of 250 cells/mm3in our cohort is 24 months 
(95% CI 18 30 months). Patients who gained more CD4 cells on therapy 
tended to lose them faster. Pulse therapy strategies deserve further 
evaluation in the setting of prospective clinical trials.

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