E-drug: Malaria vaccine (cont)
---------------------------------------------
Some thoughts on Chandresh Harjivan's comments
One of the bigger problems with current merged multinational pharmaceutical
companies is that to get involved in the developments of a new product, they
will be looking for a market size of up to $100 million to 1 billion dollars
annually. By and large, this means expecting registration and penetration
into the U.S. and European market, with patent protection.
Even with the pull market suggested, it is difficult to see how these
figures would make sense, especially if the major market was in the
developing world. There would be no free market pricing. To give you an
example of the differences between the problems, the WHO approved Yellow
fever vaccine manufactured in Africa (I think it comes from Senegal) has a
cost of 18 cents a dose. This is fine for population protection. To buy the
product retail in the developed world, patients can expect to pay 100 times
that easily, and possibly more.
To gain registration of a vaccine globally would need evidence of efficacy,
safety and quality of manufacture. The mechanism for establishing the
former has been addressed in trials run by governmental organisation
at target sites e.g MRC malaria unit in The Gambia, but as is said,
the duration of efficacy is an important part, and implies quite a
long trial to check for
long lasting immunity. Vaccine safety is never easy to establish, but in the
case of malaria, the risks of the illness in target populations are so great
that safety would not have to be the same as if it were a very precautionary
measure. Nevertheless, there is no justification for suggesting that
different standards of safety should exist between the developing and
developed world.
At the end of the day, it may be difficult to convince a classical
mainstream multinational pharmaceutical company to spearhead the
development process. The initiative would have to come from
governmental or ngo organisations such as UN or WHO. The motivations
would have to exclude profit and fear of litigation.
Dr Martin Goldman
Senior Medical Advisor, Pharmax Ltd
tel 01322 429355
fax 01322 555469
Student on M.Sc./ Diploma in travel medicine at University of Glasgow.
Martin Goldman <MGoldman@forest-labs.co.uk>
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.