E-DRUG: AIDS Drugs: No Compromise on Safety and Quality (2)
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Hello e-druggers,
I am gravely dismayed by the comments from Thompson Ayodele. Lets put some
of the issues in perspective:
1. FDCs ARV has existed before now...Combivir is an example! Thompson's
comment is a weak defense of few of the genuine concerns about FDC HAART.
Amongst which is the inability to switch or dose titrate. But it is known to
all that FDCs are not planned to cover every patient group, special patient
groups like those with the 'noxious synergy' condition of TB+AIDS and are on
treatment with ATT and HAART may not benefit from FDCs.
2. WHO prequalification is 'stringent' and the process includes:
the assessment of product dossiers containing data and information as
required in the guidelines, norms and standards of the WHO, for safety,
quality and efficacy;
the assessment of manufacturers for compliance with WHO Good Manufacturing
Practices (GMP) http://mednet3.who.int/prequal/default.shtml The details of
some of these processes are as good as what even the FDA use in New Drug
Applications. Prequalified FDCs are world standard and not rejected in the
developed worlds.
3. FDCs do not require clinical trials, generally generic or multisource
drugs do not require to prove efficacy, they only require bioequivalency and
blood level studies to establish that they are equivalent to the originator
drug. So FDCs does not require to 'undergo the rigorous testing to which the
individual pills have been subjected.'
4. The concerns about health infrastructures, corruption and lack of
political will in African leaders is a genuine concern, but does it in any
way suggest that we do nothing to arrest this pandemic which the WHO has
appropriately dubbed a world health emergency? Or do you not treat an RTA
drunken driver because he is so undisciplined to have been involved in road
accident? My experience in Botswana has proven that National rollout of ART
can indeed boost health care infrastructure.
5. The FDCs has absolutely nothing to do with the antibiotic trial in
Northern Nigeria. I will want to presume you are referring to Pfizer's
'assistance' to Nigerian government with Trovan during the Bacterial
Meningitis epidemic in Kano in 1995.
http://www.washingtonpost.com/wp-dyn/world/issues/bodyhunters/ I worked
with Pfizer in Nigeria for more than 7 years; the two issues are just not
related at all.
Finally, it is very disturbing that someone in a developing country, who
daily sees the poverty, disease and hunger of great majority of the people,
can be campaigning for less responsibility for the governments. I personally
think that developing country governments must be held responsible, if not
for anything else then for the provision of quality healthcare services to
its citizens.
Jude Nwokike
[B.Pharm, MSc Pharmacology MPH student MEDUNSA]
Prin.Pharmacist, Maun General Hospital, P.O.Box 12,
Phone 267 6865005, 6860444, Fax 267 6860819,
Maun. Rep. of Botswana.
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