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.

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Optometrist David Hartzok on LASIK

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.

FDA Enforcement Diminishing

SOURCE

A spokeswoman for the FDAs 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:

2008 2007
2006 2005
1995 thru 2004

 

FDA Oversight

SOURCE

"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:

Dingell, Stupak to Investigate FDA’s Medical Device Approval Process

FDA Medical Device Safety

FDA Drug Safety

FDA Food Safety

FDA's Conflicts of Interest

FDA's Compensation Practices

FDA Office of Regulatory Affairs Reorganization

FDA No-Bid Contracts

Beth Kotsovolos PDF Print E-mail

Page 91

14 My name is Beth
15 Kotsovolos, and Matthew, obviously, the
16 previous speaker, is my husband.
17 When you look upon my husband and
18 myself, you may not see the battle scars of
19 the past two years, but they are there.
20 Despair, depression, disbelieve, anger,
21 suicidal ideation, and post-traumatic stress
22 disorder. They are there.

Page 92

1 To put it bluntly, the post-LASIK
2 symptoms of severe dry eye and unremitting eye
3 pain almost destroyed our family. My children
4 almost lost their father.
5 As I look upon the Panel today, I
6 see that many of you are LASIK surgeons or
7 have close ties to LASIK surgeons. I truly,
8 truly hope that today you can put your vested
9 ties with LASIK aside and be objective, and
10 really listen to what we have to say, the
11 people who have walked in the shoes of LASIK
12 failure.
13 So I ask the media now that you
14 hold the FDA accountable for their decisions
15 regarding whether or not the minority matter.
16 I also ask the media to not stop here, and to
17 continue investigating the stories of LASIK
18 failures and shine the light on the link
19 between bad LASIK outcomes and suicidal
20 ideation.
21 Think of the numbers of LASIK
22 surgeries that are done annually. Based on

Page 93

1 the complication rates stated, LASIK is
2 destroying thousands and thousands of patients
3 and family lives. How many will it take for
4 you to recognize that LASIK cannot continue in
5 its current form?
6 I spoke to a gentleman by the name
7 of Roger from Wisconsin. His brother, Robert,
8 was a great outdoorsman. He was a champion at
9 pack burro racing.
10 Robert kept a journal in his last
11 months before he took his life. He wrote that
12 the constant unremitting eye pain, burning,
13 post-LASIK was unbearable. He said that the
14 pain was too much to overcome. He couldn't
15 live that way anymore.
16 A young doctor who had LASIK in the
17 summer of 2003 committed suicide in September
18 of 2004. This doctor consulted with many
19 physicians in search of solutions to his post-
20 LASIK visual disturbances. He committed
21 suicide after realizing that the solutions to
22 his physical post-LASIK complications were

Page 94

1 nonexistent.
2 Major Eric J. Rupert is a military
3 physician serving in Iraq. His LASIK surgery
4 was done in July of 2003. He states, "I
5 strongly believe that the loss of tear
6 function which is deemed an acceptable
7 downside to LASIK surgery is, in fact, not at
8 all acceptable for many people who lead active
9 lifestyles."
10 Finally, Linda Knuckles had LASIK
11 surgery in January of 2007. She went from
12 doctor to doctor in her city and experts long
13 distance, trying to find help to get her life
14 back. Linda states in her testimonial, "I
15 could not escape the intense burning, even
16 with my eyes closed. I didn't want to get out
17 of bed anymore and face the day. If this is
18 what my life was going to be like, I wasn't
19 even sure I wanted to go on living. I began
20 to think about death being the only escape
21 from misery. Along with the guilt of choosing
22 to have the ill-fated elective surgery, I had

Page 95

1 to live with the guilt of what effect this was
2 having on my husband and children. I was an
3 empty shell of my pre-LASIK self in my own
4 personal hell."
5 As I read those words for the first
6 time, I was astounded as to how very similar
7 her words were to my husband's, and listening
8 to all the testimonials today again it is just
9 over and over I am hearing the same thing from
10 LASIK patients who have similar complications.
11 Linda goes on further to explain:
12 "Ten years ago I had cancer. Although it was
13 scary and difficult, I got through the surgery
14 and treatment without needing any anti-
15 depressants. In 20 minutes, as the
16 advertisers say, all of our lives were
17 permanently altered."
18 It is time for the FDA to stand up
19 and protect the public for whom it is
20 entrusted to serve. LASIK has wreaked havoc
21 upon thousands and thousands of families. The
22 eye is the most vital sensory organ that

Page 96

1 significantly impacts our quality of life. We
2 use our eyes every second of the day.
3 When you permanently damage a
4 person's previously healthy eyes, that
5 person's physical and emotional state will be
6 significantly impacted. Anyone who states
7 otherwise lacks common sense or is
8 disingenuous.
9 Permanently damaging a person's
10 most vital sensory organ with no Plan B fix is
11 not a straw that breaks the camel's back.
12 It's the 200 pound gorilla that brings most
13 post-LASIK complications --
14 CHAIRPERSON WEISS: Would you be
15 able to wrap up? We are on the red again.
16 MS. KOTSOVOLOS: Sure. I ask that
17 the FDA begin investigation of post-LASIK
18 depression and suicide ideation and its
19 clinical --
20 CHAIRPERSON WEISS: Thank you very
21 much. We are now going to go to our next
22 speaker, Mr. Michael Klein.