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 Hartzok, OD PDF Print E-mail
(The presentation was made by Glenn Hagele on behalf of Dr. Hartzok)
9 I am making the
10 statement on behalf of Dr. David Hartzok and
11 Barbara Berney, co-founders of the Vision
12 Surgery Rehab Network.
13 The Vision Surgery Rehab Network,
14 VSRN, is a 501(c)(3) nonprofit organization
15 whose purpose is to help patients with
16 complications from any surgery that alters the
17 refractive status of the eye.
18 The bulk of our work focuses on
19 LASIK patients. We define their condition as
20 refractive surgery syndrome, RSS, a complex,
21 chronic visual, psychological and
22 physiological symptoms following any surgery

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1 that affects the refractive effects of the
2 eye.
3 This Panel must be prepared to hear
4 the extremes of two sides of an ongoing
5 argument, those who maintain that LASIK does
6 not generate depression and other
7 psychological issues versus those who argue
8 strenuously that their lives have been
9 irretrievably harmed.
10 VSRN believes that both extremes
11 are at times disingenuous in their arguments
12 and unnecessarily defiant in their
13 perspective. It is our hope that the
14 definition of refractive surgery syndrome
15 and, in particular, its psychological
16 components will be recognized and accepted by
17 the FDA, and that this definition will be a
18 starting point toward dialogue between the two
19 perspectives.
20 Physical, physiological and
21 psychological symptoms following LASIK may
22 combine to produce varying degrees of RSS. A

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1 common complaint of LASIK, dry eye, may be
2 thought of as a physical symptom, dryness,
3 burning or pain, that may have physiological
4 attributes relative to an inadequate tear
5 film, which creates a psychological awareness
6 of reduced vision.
7 As a contributing factor to RSS,
8 physical dryness can be an intractable
9 condition. The other end of the RSS spectrum
10 is less tangible and leads to most of the
11 post-surgery frustrations. VSRN contends that
12 vision as a perception is more complex than
13 LASIK advocates acknowledge.
14 Vision, as described in so many
15 studies and post-operative accounts,
16 concentrates heavily on the measurable optical
17 attributes of the eye's condition. While
18 knowledge of the refractive components of the
19 eye has grown, there has been no proportionate
20 increase in understanding how the alteration
21 of the eye's optical elements adversely affect
22 perception. Clearly, a broader perspective is

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1 needed.
2 Vision abnormalities induced by
3 LASIK are perceptual in a way that existing
4 technology cannot discern. LASIK has elicited
5 the gamut of subjective response from euphoric
6 elation to panicked angst. While newer
7 technology may be safer and more effective
8 than in the past, even today's advanced
9 procedures can reduce visual quality.
10 Our world, our reality, is the
11 summation of all of our perceptions, vision
12 being the most powerful. VSRN's experience
13 with patients is that LASIK alters their
14 reality in ways that disrupt their sense of
15 normalcy and well-being.
16 LASIK is an elective procedure. It
17 is natural for providers to downplay negative
18 outcomes, particularly when there is no
19 causative effect.
20 Too frequently, patients'
21 frustrations are compounded by denial of the
22 complaints by surgeons and other post-surgery

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1 examiners. They begin to believe that denial
2 is systemic in the industry and that their
3 doctors are uncaring.
4 Those feelings, combined with
5 aggressive marketing and inadequate informed
6 consent agreements exacerbate the
7 psychological aspects of RSS. Patients'
8 visual perceptions should be validated, not
9 denied.
10 The loss of visual quality reduces
11 patients' overall sense of well-being and
12 leads to depression and chronic anxiety. How
13 doctors manage LASIK problems is just as
14 critical to their patients' recovery as the
15 optical outcome. Any sense of non-caring
16 creates additional stress for the patient.
17 The visual complications of LASIK
18 suggest that certain properties in curvatures
19 of the cornea are unique to the individual and
20 may not be subject to generalized nomographic
21 approach.
22 Even Wavefront analysis, while

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1 elegant and attractive, fails to guarantee a
2 satisfactory surgical result. Patients with
3 Wavefront customized surgeries regularly
4 contact VSRN for help with RSS.
5 Rigid gas permeable contact lenses
6 and additional surgeries are the most common
7 rehab options. Informed consent agreements
8 fail to mention that neither is consistently
9 satisfactory nor successful. Patients whose
10 rehab efforts fail to restore normal vision
11 suffer a proportionately higher degree of RSS.
12 The number of patients affected is
13 incalculable, since successful LASIK, in the
14 surgeon's view, is procedural -- you are 20/20
15 -- while success of LASIK in the patient's
16 view is perceptual -- but it's not clear.
17 RSS will continue to remain under18
reported until the doctor versus patient
19 discrepancy is resolved. VSRN believes that
20 refractive surgery syndrome results in quality
21 of life issues for a significant but unknown
22 number of patients.

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1 Any meaningful investigation of the
2 quality of life after LASIK must be impartial,
3 undertaken by behavioral and perceptual
4 specialists with no vested interest in the
5 outcome. Thank you.
6 Those are the words of Barbara
7 Berney and David Hartzog.