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

Amanda Campbell PDF Print E-mail
Page 160

9 Good morning again.
10 I am here on behalf of Amanda Campbell. My
11 name is Todd Krouner. I was recently retained
12 by her. She is a widow now in Brentwood,
13 Tennessee, whose husband, Lawrence Campbell, a
14 police officer with that police force, shot
15 himself with his service revolver last month
16 on March 16, 2008.
17 Ms. Campbell regrets that, given
18 her current circumstances, she is not able to
19 afford the trip here to Maryland today.
20 In a March 25, 2008, article
21 reported in the OSN supersite, Dr. Richard
22 Lindstrom, who you know as President of ASCRS

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1 and OSN Chief Medical Editor, is quoted as
2 asserting that there is no correlation
3 whatsoever between adverse LASIK outcomes and
4 suicide.
5 Presumably, Dr. Lindstrom did not
6 have the benefit of reading police officer
7 Campbell's suicide note.
8 In my April 15, 2008, written
9 submission to the FDA, I referred to Dr.
10 Lindstrom's assertion, but in my letter I also
11 questioned the integrity of certain Titans in
12 the LASIK industry, and I want to be clear
13 that none of those comments are meant to cast
14 any such aspersion on Dr. Lindstrom. However,
15 I respectfully disagree with his absolute
16 position based on the explicit statements in
17 police officer Campbell's suicide note from
18 just last month.
19 He states: "No one knows what I am
20 feeling, constant pain, blurred vision, stress
21 that I never had before. If only Dr. Robert
22 P. Selkin had done a pre-op and knew I was not

Page 162

1 a candidate for LASIK surgery.
2 "No one understands truly my burden
3 I carry, dry eyes, cannot light a fire, cannot
4 stand in front of air conditioning, cannot
5 cook without opening a window, cannot spray
6 deodorant. The list goes on and on.
7 "I just cannot burden my family for
8 a poor decision, eye surgery, which Selkin
9 knew was wrong but only wanted money, and I
10 will not live on drugs, Xanax. I never used
11 that drug wrong, a half a milligram at night
12 and sparingly in the afternoon on a bad day.
13 I am not a drug user. Never could I do this,
14 as it has ruined so many lives."
15 He goes on to state, "Do not have
16 LASIK surgery. Tell the media."
17 On behalf of the Campbell family,
18 that is why I am here on their behalf today.
19 If there were any question about the cause of
20 police officer Campbell's suicide, he states
21 explicitly: "To blame for this, Selkin eye
22 surgery. Eye surgery has taken my life out of

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1 me. The pain, distorted vision, chronic dry
2 eye is not bearable" -- emphasis in original.
3 Out of fairness to Dr. Robert P.
4 Selkin, I do not know today if he committed
5 medical malpractice in the tragic Campbell
6 case. However, out of fairness to Lawrence
7 Campbell's widow and two children, to date
8 inexplicably they have been denied access to
9 eye records.
10 What is clear in this case -- and I
11 emphasize this one case -- is that LASIK
12 surgery clearly constituted a material
13 contributing factor, if not the sole factor,
14 to police officer Campbell's suicide.
15 To Mrs. Campbell's knowledge,
16 prior to his LASIK surgery she reports that
17 her husband suffered from no mental illness
18 whatsoever.
19 Now you have heard today and
20 certainly recognize that LASIK surgery helps
21 the vast majority of patients who have it.
22 For a small minority, their regret is

Page 164

1 profound.
2 For a smaller minority of patients
3 still, depression associated with their visual
4 disability is real. The association with
5 suicide and bad LASIK outcomes, however rare,
6 cannot be dismissed, and warrants further
7 investigation.
8 As a final point, I would just like
9 to call the FDA's attention to its reporting
10 obligations. The FDA's work should be
11 transparent and readily available to the
12 public. It is not always.
13 Nine months ago, my law firm served
14 a Freedom of Information request to obtain
15 information concerning the Administration's
16 recall of the Alcon LADARVision 6000. To
17 date, we have still received no substantive
18 response.
19 Vindication of injured patients'
20 rights depends on timely disclosure of such
21 information. Thank you.