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

Roger Davis, PhD PDF Print E-mail
Page 165

2 Panel members, my name
3 is Roger Davis. I have a PhD in clinical
4 psychology with perhaps 20 publications,
5 including several co-authored books and
6 psychological tests.
7 Back in 2000 I served as Director
8 of Research for the Surgical Eyes Foundation,
9 now VRSN. I have communicated with about 300
10 patients with LASIK complications. Over 100
11 have told me that they have considered
12 suicide because of their LASIK. Perhaps 90
13 percent indicates some element of deception,
14 which then drives the development of post15
traumatic stress, depression and suicidal
16 ideation.
17 While Director of Research, we
18 submitted a study on depression and suicidal
19 thoughts to a major refractive surgery
20 journal. Among 58 patients admitting suicidal
21 ideation, 83 percent stated they were told
22 they were a success by their surgeon.

Page 166

1 In 115 patients who were severely
2 depressed, the number was 76 percent.
3 Interestingly, the single complication most
4 strongly associated with suicidal ideation was
5 dry eye syndrome, considered a side effect or
6 symptom.
7 My most important point here today
8 is that patients respond emotionally to their
9 total situation, not simply to their eyes.
10 With minor complications, they develop various
11 adjustment disorders. With severe
12 complications, however, they develop what I
13 have termed refractive surgery shock syndrome,
14 which includes major depression, suicidal
15 ideation and post-traumatic stress.
16 Suicidal patients pass through
17 several stages of inquiry. First, they ask
18 such questions as "Will I ever get my vision
19 and my life back? Why didn't they tell me
20 this could happen? Why didn't my informed
21 consent mention this? Why didn't my surgeon
22 tell me I could have more than one

Page 167

1 complication?"
2 Eventually patients move on to ask
3 questions about their surgeon: "Why is my
4 surgeon telling me nothing is wrong with my
5 eyes? Why are my complaints not being
6 recorded in my medical chart? Is my surgeon
7 really as good as he was presented? What if
8 my surgeon really does not understand what is
9 wrong with my eyes? If my doctor doesn't
10 understand, will anyone understand?"
11 Eventually, patients find others
12 like themselves on the Internet, and now they
13 begin asking questions about the industry
14 itself: If LASIK is so safe, why are so many
15 other patients out there with complications?
16 Why are so many patients telling the same
17 story? How are they getting away with this?
18 Why doesn't the FDA step in and stop this?
19 Why don't honest doctors speak up about this?
20 Is it really all about money? Am I the
21 victim of a medical cover-up?
22 Obviously, every patient who thinks

Page 168

1 about suicide following LASIK wants to get
2 away from their eyes. Beyond this, however,
3 there are individual differences.
4 Some individuals have traveled
5 widely looking for solutions. Since they have
6 done everything they could possibly do, for
7 them suicide seems like a rational option.
8 Here, suicidal thoughts express the desire to
9 be done with the journey.
10 Many individuals see themselves as
11 victims of a corrupt industry. They feel
12 powerless to help themselves or others. Here,
13 suicidal wishes express the desire not to be a
14 victim, simply to return to a world of
15 integrity, compassion and purity.
16 Some patients vacillate between
17 periods of crisis and exhaustion, living on
18 the bring, constantly in fear that their
19 vision is getting worse. They have no time
20 for anti-LASIK activism. Here, suicidal
21 wishes express the desire to escape the
22 anxiety and unpredictability of complications.

Page 169

1 Some patients feel that no one
2 understands their situation, not their doctor,
3 not their family, not even other patients.
4 Suicidal wishes express the desire to have the
5 severity of their vision issues finally
6 appreciated. If I kill myself, someone will
7 finally understand how bad it was.
8 Some patients feel that they paid
9 to have their vision destroyed. Here,
10 suicidal thoughts express guilt at having
11 wasted one's potential as a human being.
12 In my experience, no pre-existing
13 psychopathology is necessary for patients to
14 develop suicidal ideation post-LASIK. Decades
15 of psychological research has shown that
16 catastrophic injuries of all kinds produce a
17 period of prolonged psychological crisis and
18 adjustment. Why should catastrophic LASIK
19 injuries be any different?
20 I have not known perfectionism or
21 body dysmorphic disorder to play a role in
22 post-LASIK depression or suicide.

Page 170

1 I ask that the upcoming FDA study
2 address psychological construct such as
3 deception and adequacy of informed consent in
4 existing patients, in a prospective study that
5 could decide the future of the industry.
6 Patients may have different experiences and a
7 higher standard of care.
8 Also, I suggest to the Panel that,
9 if the FDA wants to understand depression and
10 suicide post-LASIK, forget about satisfaction
11 surveys. If you want to understand suicidal
12 patients, study suicidal patients. You can
13 find as many as you want.
14 Finally, I ask the Panel to declare
15 a moratorium on the use of the excimer laser
16 for refractive surgery. Research connecting
17 complications to quality of life problems
18 provides the ethical basis for informed
19 consent. That research should have been done
20 10 years ago.
21 Because this research does not yet
22 exist, refractive surgery cannot be performed

Page 171

1 ethically, whatever its satisfaction or
2 complication rate. Thank you.