[Ip-health] WJS on $802: $282 million for clinical trials?

[George M. Carter]

At 07:34 AM 12/4/2001 -0500, you wrote:
>snip...
>The average number of patients cited by the FDA for HIV ARV drug
>approvals was about 1,200 patients, a significant number of them in
>government funded trials.  Are you saying the industry spend $235,000
>(risk adjusted, but before financing costs) per patient in these trials,
>after government grants?  Is this your idea of educating the public?
>How does this compare to the TB Alliance estimates of what the costs of
>trials will be?   How does it compare to the money the NIH spends per
>patient on cancer trials?

If you get a reasonable answer, I'd like to know. Many variables will 
affect the cost of an individual study, such as number of participants, how 
much they bribe...er...pay the physicians per enrolled patient, cost of the 
drug, costs of tests (blood work, etc.), statistical analysis. Ranges for 
study costs run from around $50,000 at a bear minimum to $350,000 for a 
study of a phase I or phase II variety. Phase III I think can cost a lot 
more, as they have many more patients.

But this notion that "gee, if we'd sat around with our thumb up our ass and 
let it accrue interest, we'd have made this much instead of spending it so 
this we can call a cost" sounds like a shell game to me!  What a crock. 
Hey, they could have invested it in Enron, too!  Sheesh. It doesn't 
justify  screwing the crap out of sick people.

Of course, as you note, WHO pays those costs is not always 
clear.  Sometimes the venture capitalists raise the funds for a start up. 
The NIH clearly was the primary funder for much of ARV. Interesting book 
for a number of reasons that I just read is Quinn, Susan. Human Trials: 
Scientists, Investors, and Patients in the Quest for a Cure, Perseus 
Publishing, Cambridge, Mass:2001.

This comment warrants scrutiny:

""The number of patients in a new drug trial has increased from about
1,300 in the early 1980s to more than 4,000 for a typical new medicine
today," Mr. Gilmartin said."

Why is this? I think the answer here is because the industry is pumping out 
mediocre or me-too drugs, and the only way to tease out a statistically 
significant difference is to jack up the n enormously. Yes?

God knows, the industry nearly always lies when they promise to do phase IV 
post-marketing studies...and we only gradually learn of significant 
toxicities covered up, downplayed or legitimately unrecognized in 
pre-approval studies. As well as  limitations on efficacy--which all 
magically appear when the patent runs out and the next marginally helpful 
drug is introduced.  (This isn't to say there aren't some significant 
breakthroughs, but it is my contention that these may even be slowed by a 
lack of interest in their pursuit until patents run their course and every 
dime can be squeezed out of a drug--this seems to be true in the specific 
case of HCV disease where it seems like novel therapies are awaiting the 
expiration of interferon and ribavirin patents. Maybe I'm just too cynical.)

Finally--

"Dr. DiMasi has been issuing research-cost estimates for years based upon
proprietary surveys of top drug companies. "

The way the industry has lied about so much over the years, so 
routinely--the blithe way they can attack the poorest nations to prevent 
them from accessing generically-priced drugs despite KNOWING that will 
cause widespread suffering and death (an act that I still maintain legally 
constitutes a form of genocide), and the fact they keep their books so 
tightly shut--how can we possibly trust them?  When even major accounting 
firms can't catch crooks like Enron? It sounds to me like a line of patter. 
I don't dispute costs have probably risen--but for many reasons that have 
little to do with health or caring for people living with diseases, facing 
our mortality. More like pigs at the trough (with all due deference and 
apologies to those nobler, more intelligent animals).

Anyway, my interest stems also from the fact that I'm putting together a 
not-for-profit that will eventually fund clinical studies of interventions 
that do not have patents (a/k/a "dietary supplements") but that might help 
to attenuate ARV toxicities.  And I need to know approximately how much 
it's going to cost per study!  Instructive to that is a review of the 
AmFAR, CRIA and AIDS Research Alliance annual reports, looking at the 
number of studies they fund and the annual cost. It seems to me that the 
cost to run a study is nowhere NEAR what these guys are claiming, even 
taking into account failed drugs, to bring a drug to market.

George M. Carter