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

Matt Kotsovolos PDF Print E-mail
Page 85

5 Thank you. My
6 name is Matt Kotsovolos. I had LASIK surgery
7 in 2006 using the current IntraLase Wavefront
8 technology. At the time of my LASIK, I was
9 the Chief Financial Officer at the Duke eye
10 Center in Durham, North Carolina.
11 My surgery was considered a success
12 based on my uncorrected visual acuity now
13 being 20/20. However, for the last two years
14 I have suffered from debilitating and
15 unremitting eye pain as a result of LASIK.
16 The public hears LASIK complication
17 rates quoted by the LASIK industry as ranging
18 from between one to three percent. What the
19 public doesn't know, because the LASIK
20 industry markets this surgery in a most
21 unethical way, is that the complication rate
22 is likely in the 20 to 30 percent range.

Page 86

1 Data from the FDA clinical trials
2 for LASIK reveals that the FDA allows laser
3 manufacturers to hide complications such as
4 dry eyes and impaired night vision by
5 reporting these as, quote, "symptoms." The
6 overall percentage of patients reporting these
7 complications in the FDA trials is
8 approximately 20 percent.
9 In April 2007, researchers from
10 Ohio State University College of Optometry
11 published results from a review of FDA
12 clinical trials of the 12 lasers approved for
13 LASIK between 1998 and 2004, including newer
14 wavefront technology. They reported that six
15 months after LASIK, roughly 20 percent of
16 patients experienced worse or significantly
17 worse dry eyes, and six months after LASIK
18 roughly 15 percent experienced worse or
19 significantly worse night vision disturbances.
20 Recently, the LASIK industry has
21 hired a media consulting firm in its mass
22 circulated results of a global LASIK patient

Page 87

1 satisfaction rate of 95.4 percent. The LASIK
2 industry wants the public to believe that a
3 high satisfaction rate indicates a low
4 complication rate. However, being satisfied
5 with one's visual outcome and being free of
6 complications are two entirely different
7 matters.
8 Dr. Leo Maquire once wrote the
9 following in an ophthalmology editorial: "The
10 kerato-refractive literature contains
11 disturbing examples of patients who have
12 visual handicaps that place themselves and
13 others at significant risk for nighttime
14 driving accidents, and yet they are happy with
15 their results."
16 One of the most perplexing cases of
17 patient satisfaction comes from a 2007 report
18 of a patient who developed bilateral ectasia,
19 a serious sight-threatening complication which
20 may require corneal transplantation, who was
21 reportedly satisfied with his surgery.
22 As illustrated, patients can suffer

Page 88

1 significantly complications or "symptoms," and
2 still claim to be satisfied patients. Patient
3 satisfaction surveys in LASIK are guaranteed
4 to lead to skewed results and significant
5 false positive data.
6 In addition, there is enough
7 evidence for the FDA to investigate that shows
8 the effects of devastating and irreversible
9 physical complications from bad LASIK outcomes
10 often leads to clinical depression.
11 Clinical depression can lead to
12 suicidal ideation. The length between bad
13 LASIK outcomes and suicidal ideation is real.
14 The link is further evidenced by true stories
15 of LASIK patients taking their own lives and
16 leaving suicide notes behind that detail their
17 struggles due to debilitating post-LASIK
18 complications.
19 I have met plenty of people who are
20 depressed and considering suicide because of
21 complications that are currently buried in the
22 device labeling and classified as symptoms or

Page 89

1 side effects. How is it that patients want to
2 commit suicide because of side effects?
3 Can the Panel before us today
4 explain this? Why was there no research into
5 what constitutes a symptom, and what
6 constitutes a complication? Was it so that
7 the LASIK industry could obtain approval for
8 medical devices that otherwise would never
9 have seen the light of day?
10 Patients do not want to continue to
11 exist as helpless victims with no solutions
12 and no voice. The LASIK industry wants to use
13 the upcoming quality of life study that will
14 not commence until sometime in 2009 to stall
15 for an extended period of time. The time for
16 stalling is over.
17 I urge the FDA Advisory Panel to
18 recommend placing a moratorium on LASIK until
19 a proper comprehensive study of long term
20 LASIK patient complications and symptoms,
21 including clinical depression, is completed.
22 I ask the FDA to change the

Page 90

1 labeling for lasers for LASIK once this
2 moratorium is lifted, to report dry eyes and
3 night vision disturbances as complications and
4 not symptoms. Both of these so called
5 symptoms can last for a patient's entire post-
6 LASIK lifetime.
7 Those who are familiar with the
8 phenomena of deep capture understand that over
9 time regulatory agencies end up being
10 controlled by the very industries they are
11 supposed to regulate. The FDA is now
12 controlled and works for the benefit of the
13 LASIK surgeons and LASIK manufacturers.
14 This is easily illustrated by an
15 ASCRS press release on April 7, 2008, a full
16 two weeks before today's hearing. In that
17 press release, the FDA stated that LASIK is
18 safe and effective.
19 Clearly, the fix is in. ASCRS
20 would not have issued such a --
21 CHAIRPERSON WEISS: Can you please
22 start closing your remarks?

Page 91

1 MR. KOTSOVOLOS: Yes, thank you.
2 Clearly, the fix is in. ASCRS would not have
3 issued such a press release, had they not
4 known in advance that the FDA was going to
5 dismiss --
6 CHAIRPERSON WEISS: We are going on
7 to our next speaker, please. Thank you.
8 (Applause.)