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

Terrilyn Bankes, MD PDF Print E-mail

Page 144

21 I am Dr. Terylyn F.
22 Bankes, and I have no conflict of interest

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1 with LASIK surgery.
2 I am going to present my part, and
3 then I have been requested by a patient, Kim
4 Harringer, to report on her story as well.
5 I have heard about the problems --
6 CHAIRPERSON WEISS: As long as you
7 do it in five minutes.
8 DR. BANKES: I will. I have heard
9 about the problems that patients with poor
10 visual outcomes have been experiencing since
11 2000. I volunteered to be the physician
12 counselor for several LASIK patient support
13 group meetings held throughout the Tampa Bay
14 area from 2001 through 2004.
15 Meetings consisted of from 10 to 30
16 various members, all of whom had visual
17 problems following refractive surgery.
18 Members described a variety of emotional
19 responses, including depression, anxiety,
20 difficulty sleeping, and panic attacks. Many
21 had self-anger, taking responsibility for
22 their poor outcomes upon themselves.

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1 They bitterly complained of the
2 expense of trying to find visual solutions.
3 Some called LASIK the "stupidest thing I ever
4 did." They bemoaned their loss of autonomy,
5 especially their decreased night vision and
6 visual aberrations that kept them from
7 recognizing people when in dim light
8 situations, made night driving an
9 impossibility, reduced their ability to read,
10 and threatened their job security.
11 Many became obsessed with their
12 vision and reported that they felt estranged
13 from family and friends who did not want to
14 talk to them anymore about their continuing
15 insolvable problems.
16 The ophthalmologic surgeons
17 routinely discounted their symptoms or were
18 unable to deal with them as patients. I heard
19 stories of true depression, suicidal ideation
20 and rage.
21 Ophthalmologists I currently work
22 with on a daily basis have expressed the

Page 147

1 concern of what LASIK will do for cataract
2 surgery.
3 The method to calculate the power
4 of the intraocular lens required for cataract
5 surgery is unknown, and the community
6 ophthalmologists have no way to assess the
7 intraocular lens requirements. Therefore,
8 they are unwilling to treat these patients.
9 As our LASIK patients age, the lens
10 calculations will be a growing problem.
11 Another recent question involves
12 the increasing number of LASIK flap MRSA
13 infections. Optometrists have expressed to me
14 the concern that this might become an
15 epidemic. What does the future hold for these
16 LASIK patients?
17 The problems with LASIK are a open
18 secret among ophthalmologists, many of whom
19 have patients in their practices with poor
20 outcomes. I fail to understand how the
21 ophthalmologic community can defend the
22 continuing production of life altering

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1 complications, and I view it as a true
2 disgrace of modern medicine.
3 I challenge this FDA Panel to take
4 the necessary action to protect our patients
5 in the United States. Thank you.
6 Now I am going to report on Kim
7 Harringer's story. Kim Harringer is a 44-
8 year-old woman who had -- is married, was a
9 Registered Nurse and has rheumatoid arthritis.
10 She had RK surgery in -- 14 years
11 ago, and then her vision regressed. So back
12 in 2006 she saw a surgeon who did LASIK
13 surgery on top of her previous surgery.
14 He told her that he could do the
15 LASIK surgery with no problem. Immediately
16 following the surgery, there was a problem.
17 What ensued was a nightmare of increasing
18 frustration, despair, depression, Kim sought
19 to find out what happened to her vision.
20 She was aided in her research for
21 relief by family members who sought to
22 understand what was going on with her. She

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1 was having constant problems with depression.
2 She was depressed and suicidal. She was
3 admitted to a mental hospital five times.
4 On her fifth admission, she was
5 diagnosed as having hysterical blindness.
6 Finally, recently, she found an optometrist
7 who was able to fit her with some hard
8 contacts which, while still she has problems,
9 have improved her vision somewhat.
10 She asks -- When asked what people
11 would like to learn from her experience, she
12 is very clear. The whole health field in
13 general needs to be aware and reconsider. Not
14 everyone fits into some textbook diagnosis.
15 Medical remedies trail medical
16 advances in the light of LASIK surgery, and
17 for patients like Kim, we have a lot of
18 catching up to do when it comes to
19 understanding and treating poor outcomes.
20 Thank you.
21 (Applause.)