1. The need for generic ciprofloxacin depends upon three factors.
a. Can terrorists deliver anthrax to large numbers of people?
b. Do the terrorists have access to strains of anthrax that are
resistance to other (cheaper and widely available) antibiotics?
c. Could an attack take place before Bayer could deliver large
quantities of cirpo?
2. Based upon what we know, there is a non-zero chance that all of
these things could happen. In fact, no one knows what the probability
is, but it clearly not a trivial risk, given the consequences.
3. There is evidence that the Russians have developed strains of
Anthrax that are resistant to ordinary antibiotics.
4. The Federation of American Scientists say that 100 kilos of Anthrax
could kill 1 to 3 million persons.
(http://www.fas.org/nuke/intro/bw/agent.htm#b02). Many have pointed out
that this is difficult, but it is also not impossible. There is no
evidence that the terrorists can do this, but there is also no evidence
that they cannot do this.
5. Secretary Thompson says we need medications for 10 million persons.
At the 120 pill recommended course of treatment for ciprofloxacin, this
is 1.2 billion pills. Bayer says it can produce 2 million per day. At
this rate it would take 600 days to supply 1.2 billion pills. The US is
now saying it will only provide 10 doses of ciprofloxacin, and then
switch to a cheaper antibiotic. The rationale for switching is not
clear, particular if we face an attack with a disease resistant
6. Apparently 5 generic companies have already received US FDA
clearance for the quality of their ciprofloxacin, and could immediately
be asked to manufacture the drug.
7. The US government already has the right to use patents without a
license, under 28 US 1498.
(http://www.cptech.org/ip/health/cl/us-1498.html), an authority which is
often used for other patents. The US could also pass HR 1708, which
would address the problems in 1498 regarding compensation.
8. The US can clearly address supply issues faster with six suppliers,
than with one. (see http://www.cptech.org/ip/health/cl/cipro/)
9. The US is cutting corners on public health to protect its
negotiating position in the Doha WTO meeting on November 9-13, where the
issue of compulsory licensing of drugs, and imports under a compulsory
license where a country does not have domestic capacity for production,
is a central issue, with the US, Canada and the EU opposing the Africa
10. Americans are being put at risk in order to protect the
pharmaceutical companies in Africa and other developing countries.
11. The entire dispute is about how much risk we are willing to
undertake to protect the idea that patents are more important than
public health. Thompson and others are rolling the dice, hoping we
don't need ciprofloxacin. I hope they are right and we don't need
ciprofloxacin, but I don't think we should take unncessary risks with
the public health, and certainly not to make a polemical point over
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036