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.

best oem software

  • Cheap and Discount OEM Software Online software store oem software store

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

Lauranell Burch, PhD PDF Print E-mail
Page 79

19 I appreciate the
20 opportunity to speak at this FDA hearing on
21 post market LASIK issues.
22 My name is Lauranell Burch. I have

Page 80

1 a PhD in molecular biology and genetics and
2 have been -- Am I not speaking in the
3 microphone? Sorry. -- and have been a medical
4 researcher for over 20 years. I am trained to
5 design, conduct and review medical research
6 studies.
7 I come here today as a private
8 citizen with no financial interests to report.
9 We are all aware of recent media
10 attempts by the LASIK industry to reframe the
11 discussion of these hearings around post-LASIK
12 satisfaction and quality of life issues.
13 The public should be made aware
14 that the proposed task force to examine post-
15 LASIK quality of life issues is dominated by
16 individuals with conflicts in interests. One
17 of these individuals, Dr. Kerry Solomon, was
18 quoted this week by ABC News regarding this
19 meeting, saying this is not about safety and
20 effectiveness of LASIK at all.
21 If there were no serious concerns
22 about the safety and effectiveness of LASIK,

Page 81

1 we wouldn't be here today. What is most
2 important for all of us to consider now is the
3 growing body of evidence accumulating in peer
4 reviewed ophthalmology journals that indicate
5 that LASIK is a harmful procedure.
6 Despite claims made by surgeons in
7 the industry about patient satisfaction,
8 today's happy 20/20 LASIK patients are often
9 today's dangerous drivers on our highways at
10 night due to LASIK induced loss of contrast
11 sensitivity, and may ultimately experience
12 debilitating late onset complications of
13 LASIK.
14 Patients who report that they are
15 currently happy with the LASIK procedure
16 likely have no idea of the nature and extent
17 of the damage they incurred during the LASIK
18 procedure, and the consequences of this damage
19 for their future ocular health and vision.
20 I believe that no patient would
21 want this surgery if they fully understood its
22 consequences.

Page 82

1 Here is a short list of permanent
2 adverse effects of LASIK eye surgery. Number
3 one, the flap never heals. It just seals it
4 better on the edges like a Tupperware lid,
5 leading patients who have had LASIK
6 susceptible to traumatic flap injury for life.
7 Number two: LASIK separates the
8 stronger anterior corner, leaving only the
9 weaker posterior cornea to support the
10 intraocular pressure of the eye. This can
11 lead to corneal ectasia and corneal failure
12 months or years after the surgery.
13 Number three: LASIK causes
14 permanent pathologic changes in all corneas.
15 According to an Emory University study that
16 examined post mortem LASIK corneas, a spectrum
17 of abnormal histopathologic and
18 ultrastructural findings was present in all
19 corneas.
20 Some examples of these findings
21 include: Deranged and disordered collagen
22 fibers, granules under the flap, and

Page 83

1 epithelial ingrowth under the flap.
2 Number four: There is no evidence
3 that corneal nerves ever fully regenerate to
4 their normal patterns and density after LASIK.
5 Number five: LASIK complicates
6 future cataract surgery.
7 Number six: LASIK invalidates
8 intraocular pressure motion which is critical
9 in the diagnosis of glaucoma.
10 Number seven: Perhaps gravest of
11 all, Mayo Clinic researchers recently found
12 that all patients undergoing laser corneal
13 refractive surgeries lose coracite or corneal
14 stromal cell density at higher rates even
15 years after surgery.
16 Apparently, excimer laser ablation
17 to corneal stroma results in progressive cell
18 loss in the cornea. In a peer discussion
19 following this study, LASIK surgeon Dr. Roger
20 S. Steiner commented, and I quote him, "One
21 can speculate that this loss might lead to
22 corneal ectasia."

Page 84

1 Clearly, patient satisfaction
2 surveys are no substitute for objective,
3 quantitative testing, particularly when the
4 technology for performing objective tests is
5 widely available.
6 I ask that the FDA abandon the
7 proposed quality of life study in favor of a
8 study which objectively and quantitatively
9 measures aspects of post-LASIK dry eye disease
10 and post-LASIK visual quality.
11 These studies can be performed on
12 existing patient populations with unoperated
13 eyes serving as controls. Withdrawal of FDA
14 approval for the LASIK procedure should take
15 place immediately pending the outcome of these
16 studies.
17 Only then will the FDA be able to
18 achieve evidenced based policy about corneal
19 or refractive surgery devices, and only then
20 will the public receive the benefits of
21 evidence based medicine. Thank you.