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

Todd Krouner PDF Print E-mail
Page 122

8 My name is Todd J.
9 Krouner. I am a plaintiff's medical
10 malpractice attorney from Chappaqua, New York.
11 I am here at my own expense today.
12 I represent victims of LASIK and
13 related eye malpractice on a national basis.
14 Most of my cases involve high volume LASIK
15 facilities that fail to screen properly for
16 keratakonis or other contraindications to
17 surgery.
18 I am not here to criticize the
19 safety of LASIK. I am not here to criticize
20 ophthalmologists generally or LASIK surgeons
21 in particular. I am here to encourage the FDA
22 to do whatever it can to prevent the

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1 conversion of eyes to commodities by doing
2 four things:
3 First, encouraging the effective
4 and safe training of LASIK surgeons; second,
5 encouraging the reporting of adverse outcomes
6 by the industry; third, commissioning an
7 independent study of LASIK patient
8 satisfaction; and fourth, reporting on its
9 findings and making its data available on a
10 timely basis.
11 The LASIK industry does not police
12 itself effectively. Many doctors have
13 completed rigorous training with cornea
14 fellowships. However, many LASIK surgeons
15 have not.
16 The surgery itself is not that
17 complex. However, the screening process can
18 be. More time, skill and care need to be
19 invested to assure that unsuitable LASIK
20 candidates are screened out.
21 The LASIK industry under-reports
22 adverse outcomes. Even doctors with a duty to

Page 124

1 report have failed to do so. Voluntary
2 reporting should be encouraged. Mandatory
3 reporting failures should be enforced with
4 meaningful sanctions.
5 If the LASIK community really
6 believes that patient satisfaction at runs
7 upwards of 95 percent, then I suggest it
8 should welcome with open arms an independent
9 study to prove this.
10 Patient satisfaction must be
11 measured by both qualitative and quantitative
12 measures. It is not enough to say the patient
13 has good visual acuity.
14 My client, Mark Schiffer, had good
15 visual acuity. He had poor visual quality.
16 When his eye doctor saw this iTrace result,
17 and focus on the top right quadrant where
18 there is an "E," which depicted how the
19 patient saw an E on the eye chart, the doctor
20 scheduled his corneal transplant.
21 When Ros Martinez in Virginia Beach
22 complained of poor visual quality, her

Page 125

1 optometrist used this NIDEK technology to
2 demonstrate how poor her vision was, even
3 though her LASIK surgeon boasted of 20/30
4 corrected visual acuity and 20/40 uncorrected
5 visual acuity.
6 In March 2008, in a biographical
7 story in the New York Times, Abby Ellin
8 described her own LASIK surgery regret. She
9 described her doctor's false measure of
10 success based solely on her good visual
11 acuity. However, it is only half of one's
12 vision. Visual quality comprises the other
13 half.
14 For an impeccably credentialed
15 LASIK surgeon to say the surgery was
16 successful because the patient has good visual
17 acuity is, frankly, dishonest. Yet I hear it
18 often, of the homemaker from West Virginia
19 who took her cat's medication while the cat
20 took her thyroid medication for three days due
21 to blurred vision, of the surgical assistant
22 in Virginia Beach who cut the patient instead

Page 126

1 of the surgical thread due to poor contrast
2 sensitivity and impaired depth perception, and
3 of the executive in New Jersey whose son asks,
4 daddy, why don't you play with me anymore, due
5 to photosensitivity and irritation from the
6 elements, including wind, dust and sand.
7 If just one percent of LASIK
8 patients have a bad outcome, depending on
9 one's numbers, that may mean upwards of 10,000
10 patients per year will suffer potentially
11 serious visual disability.
12 It is reported that the
13 overwhelming majority of such cases are
14 avoidable or, in my view, constitute
15 presumptive evidence of medical malpractice.
16 Studies indicate that these cases are a result
17 of either the doctor's failure to screen
18 properly or missing warning signs such as
19 keratakonis, or the surgeon cutting the cornea
20 too thin, giving rise to post-LASIK ectasia.
21 The likelihood of serious visual
22 disability in this patient population is high.

Page 127

1 As visual learners, 85 percent of what we
2 perceive comes through our eyes.
3 Consequently, the likelihood of clinical
4 depression in this visually disabled
5 population is high. The incidence of suicide
6 in this population, while exceedingly rare, is
7 not hard to fathom.
8 I look forward to coming back and
9 speaking on behalf of Amanda Campbell. Thank
10 you.