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

Joseph Scnell PDF Print E-mail
Page 186

16 That's Joseph Schnell.
17 I had LASIK performed on myself on both eyes
18 on March 29, 2007, at LASIK-Plus in New Jersey
19 using the Bausch & Lomb 217A Technolas excimer
20 laser. I will be addressing quality of life
21 issues as well as commenting on my experience
22 just with refractive eye surgery and thoughts

Page 187

1 about this industry.
2 My overall experience with LASIK
3 has been and continues to be at odds with what
4 the refractive eye surgery industry,
5 specifically LASIK, advertises and promotes
6 for prospective patients. There is no event
7 in my life that has so negatively impacted my
8 physical, emotional, visual and psychological
9 health as my LASIK procedure.
10 This is so, despite having been
11 classified as having a fairly good result by
12 an anti-LASIK optometrist, having received no
13 significant determination of problems from
14 evaluations at Eye Hospital and University of
15 Pennsylvania's Scheie Institute, both located
16 in Philadelphia, PA.
17 I personally have deemed my vision
18 and eye health to be far inferior now than it
19 was before LASIK, and I am amazed at how this
20 elective procedure is pushed and promoted as
21 being so beneficial for the patient.
22 Even if there were no serious

Page 188

1 complications or side effects, LASIK's
2 effects, including intended effects, are at
3 odds with what is beneficial for patients. I
4 was shocked after having learned with the
5 passage of time that many of the so called
6 possible side effects are quite universal and
7 far from remote possibilities as the informed
8 consent and doctors, clinics, employees of
9 LASIK would have patients believe.
10 If you talk long enough to almost
11 any LASIK patient, you hear about dry hear in
12 varying degrees, lack of crisp vision compared
13 to glasses, the much worse close vision than
14 with glasses for older patients, worse
15 astigmatism, many times not correctable with
16 ordinary contact lenses or glasses and
17 sometimes not at all.
18 A former union member of mine
19 suggested I consider LASIK, because our health
20 plan covered most of the cost of the
21 procedure. He had recently had the procedure
22 done at the time he told me.

Page 189

1 About one and a half years later, I
2 heard from yet another member of the same
3 union tell me of how bitterly the first
4 mentioned member was complaining of night
5 vision disturbances and how miserable he was
6 over the effects of LASIK, and herein lies a
7 very disturbing phenomenon: Many glowing
8 testimonials from LASIK patients, despite the
9 fact their vision has markedly decreased from
10 once what it was.
11 I know of at least one reference
12 suggesting that patients of LASIK and other
13 forms of refractive eye surgery have such poor
14 dim light perception that it would render them
15 unable to obtain a driver's license in
16 Germany.
17 After LASIK, I acquired many
18 problems as a result of the surgery. At
19 night, I experience glare, halos, starbursts,
20 and disturbing astigmatism as I look at the
21 moon, traffic lights and other lights on
22 billboards and such.

Page 190

1 My dim light perception is
2 significantly less than what it was before
3 LASIK. Many times when driving, I look into
4 less lit areas of the roadway and see only
5 darkness. I still have memories of what my
6 nighttime vision was before LASIK, and it was
7 excellent. Now it is quite poor.
8 My right eye has significant
9 ghosting, even during the day. It gets
10 considerably worse when I am stressed or sick.
11 It seems as if my eyes never work together as
12 well as they used to before the LASIK
13 procedure. They are often uncomfortable
14 during the day, sometimes feeling dry,
15 sometimes feeling watery and sensitive.
16 I had floaters before LASIK, but
17 they multiplied extensively after LASIK,
18 especially in the right eye. These new
19 floaters make reading and driving more
20 difficult, on top of the other LASIK induced
21 problems I experienced, because many are in
22 the central field of my vision.

Page 191

1 Another recent problem that has
2 developed is that, when I look to my extreme
3 left, I see double of everything.
4 My eye and vision problems are not
5 the only result of LASIK. Directly coinciding
6 with the aftermath of my LASIK problems, I
7 have and continue to experience physical and
8 psychological problems as well.
9 Within one or two weeks after
10 LASIK, I began to suffer from suicide ideation
11 and extreme anxiety. Sometimes I felt like my
12 heart would just give out.
13 A clinical psychologist and
14 optometrist have told me that I am most likely
15 suffering from some form of post-traumatic
16 stress disorder. The suicide ideation had
17 mostly resolved itself from the tremendous
18 support I received from fellow LASIK sufferers
19 and doctors who treat post-LASIK problems.
20 For some months, I had daily nausea
21 and gastrointestinal upset. I still
22 experience these symptoms to this day, though

Page 192

1 not necessarily every day.
2 I have developed a swallowing
3 reflex that I cannot will away. I sometimes
4 choke on my food. I oftentimes feel as though
5 someone is pressing both of their thumbs on
6 the front of my neck under my Adam's apple.
7 I also oftentimes develop a lump in
8 my throat when driving in the dark, as I know
9 my dim light perception is not what it once
10 was.
11 I wake almost every day with very
12 dry mouth and nasal passages. Even when I am
13 feeling somewhat positive, this feeling of
14 impending dread overtakes me at times. I
15 never had the above symptoms until they
16 shortly developed after my LASIK procedure.
17 No stress or passing of loved ones
18 have come even close to the suffering I have
19 experienced, and still do, as a result of my
20 LASIK procedure and severe regret of buying a
21 package of lies that fooled me into getting
22 the surgery on two of my most precious organs.

Page 193

1 The informed consents are
2 structured and legally tweaked to protect the
3 company and the LASIK surgeon. There is a
4 statement at LASIK-Plus informed consent that
5 separates the center and surgeon as separate
6 entities.
7 I only met with my surgeon five
8 minutes before the procedure. He stated that
9 I received the informed consent one week
10 before my LASIK procedure. I told him he was
11 mistaken about that.
12 I was given the informed consent on
13 the day of the surgery, after my eyes had been
14 dilated. I could barely see the print, if at
15 all.
16 CHAIRPERSON WEISS: Would you be
17 able to conclude your comments, please?
18 MR. SCHELL: Yes. In retrospect, I
19 realize I should have exercised better
20 judgment, the way things went down, but I
21 thought LASIK had been around long enough that
22 this is the way things are done.

Page 194

1 In the brochure that LASIK --
2 CHAIRPERSON WEISS: Unfortunately,
3 we will have to end at this point. Thank you.