[Ip-health] Two questions for Joseph DiMasi

[James Love]

Joe, regarding the question of how reasonable or representative are your
recent estimates of the costs of clinical trials, I believe we can
settle this by getting just two numbers from you or Henry.

1.  What do you assume are the average number of patients in trials used
for FDA approval?

2.  What is the average cost per patient for those trials?

These are not only basic data that anyone looking at this issue would
want to know, but these are also numbers that are subject to independent
verification regarding reasonableness.   For example, one can in fact
check on the average number of patients cited in FDA approval letters
for new chemical entity NDAs, and one can also check with industry and
non-profit sources on the actual per patient costs of trials.  For
example, a year ago one big pharma company told us its fully loaded
costs of trials, including analysis would be $10 to $15 thousand per
patient.  If this was correct (and for some products, this is clearly
too high), then every 1,000 patients would cost $10 to $15 million.

(I note that AZT was approved on the basis of 282 patients, several AIDS
drugs were less than 1,000 patients, Glivec was less than 1,000, etc,
while some other drugs may have more than 20,000).

Also, in this regard, do you believe there are any economies of scale
regarding the per patient costs as the size of the trials increases?


Jamie

--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040