Re: New member introduction / Welcome Wilson

[Wilson DeCamp <Tonyd92236@xxxxxxx>]

In a message dated 12/19/2006 2:02:23 A.M. Eastern Standard Time,
nedgardner@xxxxxxxx writes:

Welcome  Wilson:
I am interested in your perspective on the  following.  Here in the US our
business friendly president  has  granted the drug companies something called
"fast track" status on the  development and testing of new drugs.  This allows
new drugs to come to  market with far less testing than in the past, and
insuring even greater  profits for the drug companies. We have seen several 
recalls
of these fast  tracked drugs only after they have injured or killed many in
the general  population. How can the potential consumer assess the safety issues
and make  informed decision.

My feeling is that before a new drug can be  marketed, the producers must
first prove it is better than any thing currently  available.

Ned



While Ned is right to be concerned about the increase in drug recall in
recent years, I haven't been able to find any connection between "fast track"
status and safety recalls.  To my recollection from news articles, the  recalls
have usually resulted from adverse experiences that turned out to be  more
common than appeared from the clinical trials.

When a pharmaceutical company is granted "fast track" status for a drug
application, it doesn't reduce the amount of testing that will be done.  It
creates an administrative structure in which there are more frequent meetings  
with
FDA as the drug is studied, and which permits submission and review of the
marketing application in parts.  This should enable the overall review time  to
be shortened.

Another significant provision is the use of what are called "surrogate
endpoints" in the clinical trials.  These are clinical observations that  are
reasonably likely to be indicators of benefit to the patient, but are not  
cures or
measures such as survival following diagnosis.  However, there's a  trade-off
-- drugs approved on the basis of a surrogate endpoint may be  subject to
restrictions on their distribution.

As far as I have been able to establish, fast-tracking has been applied
mostly to drugs for AIDS and cancer.  PD doesn't seem to be high on the  list,
although it would seem to fit the criterion of a "serious or  life-threatening
condition".  Maybe the PD advocacy groups need to be more  aggressive with the
companies that are developing new drugs.  Remember that  fast track status has
to be applied for by the company.

There is an FDA guidance on the subject of fast track drug  applications.
I'll see if it's possible to get it posted to the listserv  website.

With regard to Ned's last comment about proving drugs to be better than  what
is currently available, that is an issue for Congress.  The Food, Drug  and
Cosmetic Act requires FDA to approve new drugs that are safe and  effective.
There is no provision for denying approval because a drug is  not better than
existing drugs.  You might reasonably argue that their  regulatory resources
would be better applied to novel -- and hopefully more  effective -- therapies
rather than those that are just as good as drugs that are  already on the
market.  But FDA doesn't have that authority now.  It's  up to use to convince
Congress to add that to the law.

I hope this has constructively answered Ned's points, and will stimulate
further discussion.

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