[TheForge] top of food chain ( was Re: (no subject) OT )

[Bruce Freeman]

I don't know the money figures, but I can vouch for the high cost of
bringing new drugs to market.

In my opinion, the most indefensible requirement placed on drug developers
is to determine drug stability. Yes, you want the drug to be at full potency
until its expiry is reached (especially an antibiotic, which, as a class,
tend to degrade at room temperature more rapidly than small-molecule drugs),
but the MEANS of assuring such stability is currently prohibitively
expensive.  Although drug manufacturers have been using accelerated
degradation studies (high temperature, etc.) for years, the FDA still
requires ambient studies.  And AFAIK, theoretical models are prohibited as
reportable data.

This means that if a company wants to claim 5-year shelf-life, it has to
TEST the drug for 5 years.  Accordingly, most drugs get labeled with shelf
lives MUCH shorter than they'd be in reality.  (Again, this may not be the
case for antibiotics.)  Furthermore, BY LAW, a drug cannot be dispensed
after it's expiry.  Hence, perfectly good drugs are being discarded all the
time, all over the world, even where they are desperately needed.

Now, stability testing might not seem like such a burden, but in fact it can
represent millions and millions of dollars in time and effort for the
developer of the pharmaceutical.  It is a major burden that the
pharmaceutical manufacturer must bear, lest he not be able to market his
product.

My take is that there should be much more flexibility in selecting the
approach used to determine stability of a drug.  In some cases, it may be
possible to determine the stability of a drug by a combination of theory and
knowledge of other, related chemicals.  In other cases, specific accelerated
stability studies should suffice completely, with no room-temperature
stability studies at all.  I do not believe there is any one possible
procedure that would suffice for every drug, and the final determination of
the appropriate means should be left to the manufacturer, with a complete
account of why it was chosen -- which would be subject to review by the FDA
and rejection if the means chosen are not scientifically defensible.  (I do
NOT trust pharmaceutical companies.  They ARE out to make money, after all.)

I think that even such a simple change in regulation as these would
massively reduce the time and cost of bringing a drug to market.

On Fri, Apr 22, 2011 at 1:01 PM, Andrew Vida <osan at netlabs.net> wrote:

>
>
> peter fels wrote:
> > Between the misuse, competition, the liabilities and the cost of
> > getting new antibiotics approved ( $900 million if successful or
> > not); Drug companies have little motivation to develop new
> > antibiotics to replace the ones that are taken out by cultured
> > reistance.
> >
>   Your information is way out of date.  As of 2005/2006 it was costing
> pharmaceutical companies something like 7 BILLION dollars to
> commercialize new drugs.  We studied this in depth in school and one of
> the big muckety mucks at Astra Zeneca came and spoke with us about it.
>
> I am all for making sure people's dicks don't fall off when taking
> someone's pills, but the FDA is wildly out of control.  Half the drugs
> approved turn out to be more dangerous than the conditions they are
> ostensibly intended to treat, so why not streamline the process and get
> the costs down if human life is in fact that cheap?  This regulatory
> framework is ridiculous.  That we trust it is even more so.
> ______________________________________________________________
> TheForge mailing list
> Home: http://mailman.qth.net/mailman/listinfo/theforge
> Help: http://mailman.qth.net/mmfaq.htm
> Post: mailto:TheForge at mailman.qth.net
>
> TheForge mail list group photo site is
> http://www.photoworks.com
> Login: blacksmithblacksmith at hotmail.com
> Password: anvil
>
> This list hosted by: http://www.qsl.net
> Please help support this email list: http://www.qsl.net/donate.html
>



-- 
Bruce
NJ