[Ip-health] Another comparison of DiMasi and PhRMA clinical trial numbers

Jamie Love james.love at keionline.org
Tue Mar 15 20:41:13 PDT 2016

Regarding Els' point and drugs with higher therapeutic benefits over
existing drugs, one can look at the FDA numbers for priority and standard
approvals, for some insight.  Based upon preliminary calculations from the
FDA medical reviews:

*  In 2014, the drugs the FDA considered for priority approval had an
average of 1,856 patients in the trials cited in the medical reviews.   The
non-priority standard approval drugs had an average of 7,035 patients in
the trials.

*  In 2013, the priority approvals had an average of 2,094 patients, and
the non-priority "standard" drugs had 4,540.

For the past five years, the priority drugs had smaller trials, every year,
and it was only close once, in 2012.  We have not calculated the 2015 data

I don't see how Professor DiMasi can continue to assert that we should be
quoting his averages as meaningful estimates for the market, when so little
is known about the drugs in his sample, other than he picked them, and when
we don't know how many of the trials he includes were for the approval of
the lead indication and how many were for subsequent expansions of the
indications.  But give the fact that this study was so widely quoted for
nearly two years before it was even published, there seem to be a lot of
people who are just looking for some industry backed numbers to quote.


On Wed, Mar 16, 2016 at 5:19 AM, Joel Lexchin <jlexchin at yorku.ca> wrote:

> But without knowing what drugs DiMasi looked at we can’t judge their
> therapeutic value. Also drugs for rare diseases by definition will have
> small numbers in the trials but since they often measure surrogate outcomes
> the small numbers don’t necessarily mean large therapeutic gains.
> Joel
> --
> Joel Lexchin MD
> Professor
> School of Health Policy and Management
> Faculty of Health
> York University
> 4700 Keele St.
> Toronto ON
> Canada M3J 1P3
> Tel:            +416-736-2100 x 22119
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> E mail: jlexchin at yorku.ca

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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