From: Dan Somers [dsomers@med.unc.edu]
Sent: Friday, April 06, 2001 9:11 AM
To: FDADOCKETS@OC.FDA.GOV
Subject: proposed disclosure rules

Briefly:

* FDA is to be commended for taking steps to remove this sort of
research from the murky shadows of the biotech industry's "cloak of
secrecy" and to make information regarding these trials publicly
available.

* I will assume that much of the resistance to these efforts stem from
the mistaken perception on the part of the biotech industry that such
disclosure will eliminate their ability to maintain "trade secrets."
Some education of the affected industry should go a long way towards
assuaging these fears, as I fear many have an overly-broad view of what
constiututes a trade secret protected from public disclosure. When some
in the industry can be so confused as to regard the consent form,
routinely presented to potential subjects, as confidential, there is
clearly a need for remedial education in what can/should be protected,
and what needs to made available for public consumption.

* Last but not least, the popular view of genetic science as a dark,
"Dr. Moreau-esque" endeavor should be greatly diminished through the
public availability of information about the research. The biotech
industry should be aware of the largely negative perceptions held by the
public. The industry may (and frequently does) blame public ignorance
for this negative attitude, yet appears to be unwilling to take the
simplest baby step towards altering public perceptions through frank and
open discussion of exactly what objectives are being pursued, and how.
The fictional Dr. Moreau desires to keep his research hidden from public
view precisely because he has something to hide. The biotech industry
does itself no favors by seeking to follow in his fictional footsteps.

Thank you for your consideration,

-Dan Somers

*** The above statement represents my views alone. I do not speak for
UNC Chapel Hill. ***

--
Dan S. Somers
IRB Coordinator
School of Medicine IRB
UNC Chapel Hill
(919) 966-1344
dsomers@med.unc.edu