Washington Wrap-Up
CDRH Weaves ‘Tangled Web’
on LASIK
The center seems to have heightened its censorship and nondisclosure
on LASIK devices.
James G. Dickinson
Oh what a tangled web we
weave when first we practice
to deceive!” Scottish poet
Sir Walter Scott famously wrote in
1808. Exactly 200 years later, CDRH
seems to be unintentionally weaving
a very tangled web over its surveillance of LASIK (laser-assisted in situ
keratomileusis) device effects.
To a historically unprecedented
degree, FDA now controls what the
public knows about its decision making. Except for disclosures coerced by
other parts of the government, chiefly
federal courts or congressional investigations, FDA is the sole determinant of what is known and when it
is known.
A rare peek into this process may
be had by examining CDRH’s role in
regulating the use of LASIK devices.
Reliable statistics are hard to come
by, but there have been published estimates that about 7. 6 million vision-corrective LASIK procedures have
been performed in the United States,
for a 95% patient satisfaction rate,
out of some 8000 ambulatory surgi-
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cal facilities (a 2007 USA Today estimate). For all this traffic, there are 15
FDA-approved LASIK devices.
A 95% patient satisfaction rate implies a 5% patient dissatisfaction rate,
which translates to 380,000 dissatisfied recipients of LASIK surgery, based
on the figures above.
For this estimated volume, CDRH’s
MAUDE database in September
showed only 194 product problem
reports since 2000 for ophthalmic lasers. The database, of course, does not
record patient dissatisfaction.
However, there has been so much
dissatisfaction that, in April 2008,
CDRH held a meeting of its Ophthalmic Devices Panel specifically
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to address patient experiences with
LASIK surgery.
This meeting is where the center’s
web begins to get really tangled. The
meeting elicited 252 written comments
from LASIK patients for the record,
which FDA has posted on its Web site
at www.fda.gov/ohrms/dockets/ac/08/
written%20comments/2008-4353-
written%20comments-00-index.html.
A quick scan of these comments
in August showed that all but two
had been redacted to delete all information identifying patients, devices, surgical facilities, surgeons, and
manufacturers. The redaction was so
complete that not even geographical
locations of events survived, rendering the posted comments all but useless for any purpose.
One representative remnant of a
comment was left to read:
I have recommende[REDACTED] edure
several times, and I will keep doing so.
I know two people who had LASIK
with[REDACTED]and, like me, do not
regret it. I understand that every case is dif-
ferent and I strong[REDACTED]that the
doctor’s role, dedication and honesty are
essential to the success of the procedure.
Why the censorship? 21 CFR 20. 103
says all public comments received by
FDA are to be available for unredacted
disclosure. My inquiries initially produced some bureaucratic evasion. One
FDA employee even suggested that
the Health Insurance Portability and
