Doctors, Optometrists, and Psychologists on LASIK and Suicide
Think LASIK is "safe and effective"? You might change your mind after watching the videos below. Compare these videos to those that document strategies used by Big Pharama to deceive the public about risk Here.
Dr. David Hartzok works to save the vision of Lasik victims. Accordingly to Dr. Hartzok, some patients with highly experienced and reputable surgeons still have bad outcomes, thus suggesting that the lasers themselves are responsible for ruining these patient's vision.
A spokeswoman for the
FDA’s
Center for Drug Evaluation and Research told the Center that since
companies have better complied after receiving warning letters, the need for
additional regulatory and enforcement actions has decreased. “We cannot measure
the agency’s enforcement success — nor can we measure industry compliance — by
counting warning letters and other actions individually,” she said. Congress
passed the Food and Drug Administration Amendments Act of 2007 last fall, giving
broader enforcement power to the agency. The impact of the law remains to be
seen.
FDA Enforcement Actions Way Down
Enforcement actions by the
Food and Drug Administration
(FDA), which oversees food and
pharmaceutical products, markedly declined under the
Bush administration. The
number of warning letters issued for various violations dropped by more than
half, from 1,154 in 2000 to 535 in 2005, according to a June 2006 report by
Representative Henry Waxman, a California Democrat, then ranking minority member
of the
House Committee on Government Reform. The “number of seizures of
mislabeled, defective, and dangerous products” plunged by 44 percent, noted the
widely cited report, which also found that officials at FDA headquarters had
“routinely rejected the enforcement recommendations of career field staff.”
Among the curtailed warning letters were those for violations of drug marketing
practices to consumers. "From 2002 through 2005… it took the agency an average
of 4 months to issue a regulatory letter, compared with an average of 2 weeks
from 1997 through 2001," stated a December 2006 report by the
Government Accountability Office
(GAO). "FDA has issued about half as many regulatory letters per year since the
2002 policy change." The FDA has also fallen short in efforts to control “off
label” drug use (using
prescription drugs for nonprescriptive conditions), according to studies
by the Center for Public Integrity and other watchdog groups. The GAO told
Congress in July 2008 that the FDA took inordinate time issuing letters for
offlabel abuses, limiting their effectiveness.
FDA's Medwatch Listing - LASIK
The FDA stated through news media prior to, and at the April 25th ('08)
Ophthalmic Panel Meeting held in Gaithersburg (MD) that it has received only 140
complaints regarding adverse events from LASIK surgeries since LASIK's inception
10 years ago.
These are SOME of the adverse events posted at the
FDA's website, listed by year:
"Several Subcommittee investigations resulted in improvements to the public health. The Subcommittee has continued its investigation into the safety of the blood supply and has been instrumental in fostering important reforms at the American Red Cross, and the FDA. The Subcommittee's continuing commitment to improve the generic drug approval process has led to increased vigor in FDA
regulation and enforcement. The Subcommittee continued its efforts to uncover and correct problems in food safety, particularly with regard to imported foods. Meanwhile, the Subcommittee's medical device investigations have highlighted both dangerous devices that were permitted to reach the market through lax approval processes, and potentially life-saving devices that have been delayed
or kept off the market due to bureaucratic infighting or regulatory ineptitude. These efforts resulted in the release of a major report and in substantial reforms at the FDA." 103RD CONGRESS (1993-1994) ENERGY AND COMMERCE COMMITTEE
The Committee's oversight efforts since then have included:
Ladies and Gentlemen:
My name is Dom Morgan. I am legally blind from
my surgeons’ improper use of an investigational
laser, a laser sanctioned by the FDA, known to
be responsible for damaging over 30 people. I had
Retinopathy of Prematurity, meaning that my
retinas were structurally incomplete at birth.
I was 20/50 and barely legal to drive when I had LASIK.
I was never a candidate. The intraocular pressure
created by the suction ring destroyed my retinas.
My problems are permanent. As retinal problems
they will never be addressed by a contact lens.
I believe my doctor knew and did the procedure anyway.
I was dropped from their clinical study. So were others.
Those data were never reported to the FDA. The doctors
sued me because I set up a website and told the truth.
I've addressed my concerns about LASIK to the FDA for
over five years, not only on my behalf, but also on
behalf of others. In 2003 I filed a petition regarding
medical devices and safety of refractive surgery, which
was ignored. Help was offered by Ombudsman Les Weinstein,
and then retracted.
My concerns today are with those needlessly damaged by
refractive surgery. Even with the most modern technology,
there are still of too many people writing me telling of
the nightmares they now live with on a daily basis. I
received several hundred emails this past year from people
seeking help. Many of those are depressed. Some of them have
confided that they want to commit suicide. And this is just
through one website. Having corresponded with many of
those patients, I believe they are just ordinary people cause
in unusual circumstances. There is nothing remarkable about them,
certainly nothing to suggest perfectionism, or any of the other
reasons that some LASIK doctors use to excuse their own bad results.
The FDA's capacity to oversee the refractive surgery industry
is in my opinion no different than the doctors who have
tarnished it. The FDA has been ineffective in overseeing
investigational studies, ineffective in enforcing the policies
mandated for the industry, and ineffective in providing thus
far the protection that many of us here today should have had.
Everyone in this room today is here for a reason. Please
do not allow what is presented to you to continue falling
on deaf ears. The public must depend on government agencies
like the FDA to protect them.
In a recent press release, ASCRS volunteered to contribute
funding for the FDA study on LASIK complications and quality
of life. The FDA has already received copious amounts of
criticism because of funding received from the pharmaceutical
industry. Essentially, industry funds the FDA, which creates
conflicts of interest. I ask the panel how funding received
from ASCRS is any different. Most of the patents who have
emailed my website feel deceived and lied to by surgeons who
have exploited the public perception that doctors are healers.
Why should damaged patients trust an organization of such
surgeons any more than they trusted their own surgeon?
Included with my submission today I would like to emphasize
are two letters previously written to the FDA, which are
already public record. These letters apply not only to me,
but many others:
The letter written by Dr. Steven Friedman to the FDA’s
Office of Criminal Investigation summarizes not only my
experience and I believe the outright criminal activity of
my doctors, but also explains why the civil justice system
does not work.
The letter written by Dr. James Salz, respected LASIK
surgeon and principal investigator for past FDA studies
emphasizes that I was not a proper candidate for LASIK and
tells why.
Also included are a few documents and previous correspondence
I sent to the FDA. I believe this further supports what I just
outlined.
My story and more can be found at lasikdecision.com.
I ask the panel to recommend to that FDA conduct its own
independent and unbiased study: Survey damaged LASIK patients
nationwide and ask how many feel lied to by their LASIK doctors.
Conducted without funding from the industry, the results might
be believable.
I would also ask that the Criminal Division of the FDA conduct
investigations of specific doctors such as mine, in regards to their
actions in dealing with many of us.
I think a moratorium on advertising by doctors is an intriguing ideal
as well. So much is made on patient selection but more should be done
on doctor selection. Maybe a website listing doctor qualifications
in a standardized verified format.
Thank you for your time and I will gladly post any presentation
unedited on my website.
Also included with Mr. Morgan's submission were inspection reports
that were obtained via the Freedom of Information Act (FOIA) from
the FDA. Mr. Morgan states the reports were asked to be returned to them
by Ombudsman Les Weinstein because they were not redacted enough and showed
"too much information the general public should be aware of".
