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

Michael Mullery, MD PDF Print E-mail
Page 150

8 My name is Michael
9 Mullery, M.D., MBA. I am a graduate of the
10 University of Notre Dame and the Pennsylvania
11 State University College of Medicine. I am a
12 Board certified medical specialist with a
13 secondary interest in psychiatrist.
14 The refractive surgery industry has
15 known since its inception that LASIK surgery
16 carriers a risk of depression and suicide.
17 Bad outcomes are not rare, and these outcomes
18 can result in serious qualitative and
19 quantitative vision losses, including
20 blindness.
21 Now the FDA is allowing the very
22 entities that have publicly engaged in

Page 151

1 minimizing these risks to conduct studies
2 looking at LASIK and its effect on quality of
3 life. This is an overt conflict of interest
4 that defies both common sense and the
5 scientific method.
6 There can be no objectivity when
7 the bottom lien is the very survival of one's
8 multi-billion dollar cash cow. It is time to
9 leave the study of the psychological
10 consequences of vision loss after LASIK to
11 mental health professionals that are better
12 trained to study this and lack any financial
13 interest in the outcome.
14 In 1999, the Journal of
15 Psychosomatics, July/August, researchers from
16 Griffith University in Australia, in
17 conjunction with the World Health
18 Organization's Center for Suicide Research,
19 reported on a study that compared suicide
20 secondary to vision loss to suicide secondary
21 to hearing loss.
22 The study found that 63 percent of

Page 152

1 hearing impaired suicides had a history of
2 mental illness, compared to only eight percent
3 of the sight impaired suicides. In this
4 study, fear of sight loss and the uncertainty
5 about future vision emerged as greater risk
6 factors for suicide than complete blindness.
7 Most importantly, however, sight
8 loss itself was identified as the main causal
9 factor for vision suicides, whereas hearing
10 suicides were coupled with several other
11 causal factors.
12 I would estimate that I have
13 interviewed close to 75 people who have
14 developed suicidal ideation as a result of
15 LASIK. What I've found is that very few of
16 these patients have a history of depression or
17 other psychiatric problems.
18 This finding is consistent with the
19 Griffith University-WHO study of vision loss
20 and suicide, and inconsistent with the
21 industry's claims that preexisting
22 psychopathology is responsible.

Page 153

1 If vision loss is causal, as the
2 Griffith University-WHO study claimed, then
3 better screening for preexisting psychological
4 problems is not the answer. Stopping the
5 vision loss is.
6 How many totally preventable deaths
7 can the FDA allow when there is absolutely no
8 medical need for a procedure? In the
9 following case LASIK itself is undoubtedly the
10 sole causal factor in this man's suicidal
11 ideation.
12 A.J. underwent LASIK and ended up
13 with a result that his surgeon could not
14 explain, severely over-corrected with
15 irregular astigmatism, A.J. could not even
16 read the big E after his surgery.
17 In A.J.'s own words, "My life and
18 world changed beyond description the next days
19 following my surgery. First, fear set in, as
20 I felt alone and helpless, as my life became
21 an endless routine. I was sitting in front of
22 slit lamps, with no improvement in my vision.

Page 154

1 I was constantly nauseous from the vision
2 imbalance and resulting headaches. Then out
3 of the blue, panic set in. I began to cry all
4 the time.
5 "There seemed no easy way out of
6 the situation I had created for myself. The
7 simple solution to eliminate glasses had
8 become my first ever experience with
9 depression, deep, deep depression, which I
10 tried to hide from my wife.
11 "My business was suffering and I
12 became obsessed with my vision, to the point
13 that I was becoming unglued. I had always
14 been a very stable person. I had no history
15 of mental illness, depression or drug
16 addiction, nor had I ever been prone to
17 violence. But now for the first time in my
18 life, I was suicidal and full of rage.
19 "How could I stop this from
20 happening to someone else, and how could I
21 make my own pain go away?"
22 In another case a dental student

Page 155

1 without any history of psychological problems
2 reports himself becoming suicidal after his
3 LASIK left him with constant headaches, blur,
4 and vision that could not be corrected with
5 glasses.
6 "I shutter to think how close I was
7 to ending my life," he says. "Taking eight
8 courses and studying for a national license
9 exam with one semi-functional eye was a
10 hellish nightmare."
11 This patient reached the point
12 where he found himself with a half-drunk
13 bottle of vodka in one hand and a loaded gun
14 in the other. Incidentally, his surgeon
15 considered him a success.
16 Another patient, S.D., with no
17 prior psychological history reports becoming
18 suicidal when LASIK surgery to correct for
19 myopia produced finger-only vision in one eye
20 and 20/200 vision in the other. She is now
21 awaiting bilateral corneal transplantations.
22 She reports that collusion by local

Page 156

1 refractive surgeons added to her sense of
2 despair, as none of the local refractive
3 surgeons who saw her for second opinions even
4 mentioned to her that she had ectasia.
5 In conclusion, patients are killing
6 themselves as a result of failed LASIK. A
7 risk of death is not an acceptable risk for a
8 totally unnecessary procedure with no medical
9 benefit.
10 Research on this issue remains
11 virtually nil, and thus the full extent of
12 this catastrophic complication remains
13 unknown. Public safety is best served by a
14 moratorium on these procedures so that these
15 previously unstudied risks can be evaluated
16 and understood.
17 Studies looking at the effects of
18 unsuccessful LASIK with depression and
19 suicidal ideations should be done by mental
20 health professionals and suicidologists who
21 are better able to assess mental health issues
22 and who lack the financial conflict of

Page 157

1 interest that LASIK surgeons and co-managing
2 optometrists obviously have.
3 If a moratorium is not immediately
4 instituted, the labeling of the excimer lasers
5 for the surgical correction of myopia,
6 hyperopia and astigmatism should be altered to
7 include risk of suicide and depression, even
8 in the absence of any preexisting psychiatric
9 history. Thank you.