"Every
year, nearly 2.5 million people go under the knife unnecessarily,
often with devastating consequences. Make sure you're not one
of them."
"... in the months and years after LASIK became ubiquitous
at 25-year class reunions, stories of eye damage and subsequent
depression, even suicides, surfaced. The surgery can, it turns
out, induce dry eyes, halos, light sensitivity, night blindness,
ghost images, keratectasia (corneal thinning and bulging) and
many other serious damaging effects.
In the nearly 10 years since he left the agency, Waxler, (now
a regulatory consultant who has stayed involved in FDA product
approvals) has come to particularly regret the LASIK decision.
Unusual for a former regulator, particularly for someone with
business before the agency, in 2010 Waxler went public with criticism
about FDA's approval standards. A year ago he went on "Good
Morning America" and told correspondent Lisa Stark, "I
did the best we could ... but in hindsight it wasn't good enough."
He heard more stories that suggested when people complained to
their eye doctors, their adverse effects were not reported to
the FDA.
The FDA issued a statement to ABC News that it considered "LASIK
lasers to be reasonably safe and effective when used as intended,"
but has launched a two-year study to take a closer look at side
effects.
Last May, Waxler became more persistent. He considered LASIK eye
surgery complications "already a major public health problem"
and he said so in a letter to the ophthalmic organization, American
Society of Cataract and Refractive Surgeons.* He told the
organization's president the group was presenting data for a safety
study in an "unethical" manner. The association president
responded in September that the former regulator's letter was
"misinformed, unsupported by evidence, and lacking in balance
and perspective."
Waxler again appeared on ABC News in September claiming "half
of LASIK patients experience side effects." A committee of
well-regarded LASIK experts (R. Doyle Stulting, M.D., Ph.D.; George
O Waring III, M.D.; James J. Salz, M.D.; James McCulley, M.D.;
Douglas Koch, M.D.; Jayne Weiss, M.D.; and Marian Macsai, M.D.,)
responded to Waxler's claim: "We believe he has no reputable
basis for such a claim since he did not produce the scientific
evidence."
Finally last month, Waxler filed a formal citizen's petition to
his former government employer requesting the FDA withdraw approval
for all LASIK devices and to issue a public health advisory for
recalling the equipment. The industry is working on newer models
and newer methods so nearsighted consumers will still be able
to get their vision remodeled (insurance companies still won't
pay for it, probably). Since it was filed, the petition has been
reposted on the Internet by numerous supporters.
In his petition, Waxler says manufacturers and also "clinics,
refractive surgeons, and agents withheld and distorted safety
and effectiveness data" and, he alleges, "in a classic
example of the fox guarding the henhouse," the "collaborators"
routinely hide reports of LASIK injuries from FDA by settling
lawsuits out of court. He also claims that equipment makers have
"cherry-picked, withheld, and hid data from FDA" that
he believes show LASIK with "excessive adverse event"
rates of 22 percent. Waxler also submitted "confidential
information" on the matter to FDA's criminal investigation
arm.
The FDA has not yet commented publicly about Waxler's petition
but an FDA spokeswoman told Politics Daily "it is a citizen's
petition and we will review it." The LASIK experts have not
commented either. See complete
article. --
See OpticianryReview.com.
*AMERICA'S
CORPORATE PRIORITY
PROFIT OVER PRUDENCE
The Wall Street-American flag
"A
corporation's first purpose is to make money for
its stockholders, not to serve the needs of consumers.
The BP-Gulf Coast oil disaster is an example of what can
happen as a result of a corporation's obsession with profits
and their indifference and insensitivity to peoples' needs."
"Corporate
America's bottom line is in conflict
with America's Health and Wellness needs."
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