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

David Snell PDF Print E-mail
8 Ladies and gentlemen, I
9 am David Shell. I elected to have LASIK eye
10 surgery for farsightedness in October of 1998,
11 the worst day of my life. In one short
12 procedure, my eyesight was needlessly damaged
13 in both eyes.
14 I went from a healthy, happy,
15 physically active, skilled engineer with a
16 bright life and career ahead of him to a man
17 able to work only with near-constant eye pain
18 and strain, who now has difficulty reading due
19 to double vision, who can no longer view a TV
20 or computer monitor comfortably and clearly,
21 who is reluctant to drive at night, into a man
22 who has been diagnosed with clinical

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1 depression.
2 For the record, my eyes were
3 problem free for 50 years. I had crisp, clear
4 vision during the day and night with the aid
5 of a simple pair of glasses. Since LASIK, I
6 am visually handicapped by double vision,
7 starbursts, glare, fluctuating vision,
8 floaters, and impaired vision in dim light.
9 And that is with my glasses or rigid contact
10 lenses. I have not experienced a moment of
11 crisp, clear, good quality vision since my
12 surgery with any form of correction.
13 What do these visual quirks look
14 like? Well, they say a picture is worth a
15 thousand words. This is a standard E chart,
16 standard Snellen Eye Chart. These are ghosted
17 eye charts. My double vision looks like this
18 chart.
19 This is the way I see when driving.
20 I have starbursts in my eyes. These are what
21 the headlights look like, before LASIK and
22 after LASIK.

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1 This is what I see when I am
2 walking with someone special at night. I see
3 multiple moons. Anybody want to have LASIK
4 now?
5 So you see, my quality of life
6 after -- and ability to perform the activities
7 of daily living such as driving, career,
8 hobbies and sports after LASIK has severely
9 been compromised.
10 In August of 2002 I testified
11 before the FDA concerning my LASIK-induced dry
12 eye. At that time, I chose to focus my
13 testimony on this relatively common and life14
altering complication.
15 My LASIK dry eye is a burning
16 and/or stinging type of pain in your eye,
17 similar magnitude to an ant sting or shampoo
18 in your eye. While this condition comes and
19 goes for me, it can be maddening at times. My
20 eyes never feel comfortable.
21 I have seen the best ocular surface
22 dryness experts in the country. I have tried

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1 everything from eye plugs to fish oil. To
2 date, no treatment for my LASIK-induced dry
3 eyes has been beneficial to any meaningful
4 degree.
5 I am back today to tell you that 10
6 years have passed, and I still suffer from
7 this problem. I recommend the FDA reclassify
8 such life-altering effects as complications.
9 Failed LASIK eye surgery may affect
10 all aspects of a patient's physical and mental
11 health.
12 For example, my LASIK-induced dry
13 eye destroyed my ability to obtain a full,
14 restful night of sleep. I typically wake up
15 three to five times during the night because
16 of the burning and stinging in my eyes. I
17 must apply ointment to my eyes to reduce the
18 pain.
19 Failed LASIK eye surgery may
20 trigger clinical depression. I was never
21 depressed in my life until I had LASIK eye
22 surgery. I had to endure two major health

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1 crises in a short period of time.
2 Ladies and gentlemen, whether you
3 pick the best surgeon, do your homework, or
4 make sure you are a good candidate, LASIK
5 surgery has inherent problems due to the
6 nature of the procedure.
7 All eyes have weakened corneas.
8 All eyes have severed corneal nerves that
9 don't grow back fully. All eyes have higher
10 order aberrations, and so on and so on. This
11 happens, whether a patient likes their outcome
12 or not.
13 I believe too many Americans have
14 been harmed by this procedure, and it is about
15 time this message is heard.
16 What I am looking for: first, I
17 think it is imperative that the FDA conduct
18 its own investigation independent of any
19 individual or group with financial interests
20 in the LASIK procedure.
21 Secondly, reclassify LASIK-induced
22 dry eye and visual quality issues such as

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1 double vision, starbursts, glare, ghosts as
2 serious complications of LASIK, not as
3 symptoms or side effects.
4 Finally, that the FDA should take
5 another look at the safety and effectiveness
6 of LASIK over the decade that has passed since
7 LASIK was introduced. I believe there is now
8 solid scientific evidence that indicates this
9 procedure is not all that safe. Thank you.