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 Patterson, PhD PDF Print E-mail
Complete FDA Transcript of Dr. Patterson's FDA Presentation

Page 17 21 Stop using medical devices for 22 LASIK. This is a simulation of the vision in Page 18 1 my left eye. LASIK ruined my vision and my 2 quality of life. Not all 20/20 is the same. 3 Eye chart at the bottom here shows what 4 doctors say is a good LASIK outcome versus 5 normal vision. LASIK often causes even more 6 vision quality loss, which is very important. 7 Partial lists of my LASIK complications 8 include: Microkeratome failure, blade reuse 9 scar, et cetera. 10 The FDA states safety was 11 determined with a risk/benefit analysis, but 12 where is it? Make the formal risk/benefit 13 analyses public. The risks of cutting a flap 14 for LASIK far away the benefits. Quality of 15 vision and Dry Eye risks were not evaluated. 16 I believe no risk/benefit analysis was 17 actually done, and the FDA will not compare 18 the safety of these dangerous devices to any 19 alternative, like contacts. 20 What value was put on human injury 21 and suffering in the FDA's analysis? Clinical 22 trials are not FDA risk/benefit analyses. Page 19 1 Devices approved for LASIK are not safe, 2 because cutting a flap for LASIK is not safe. 3 Compared to glasses or contacts, 4 there is no way the benefits of LASIK outweigh 5 the severe risks of permanent injury for life. 6 A failure rate of five percent or higher is 7 not safe, and the post-market standard of care 8 for LASIK is not safe. 9 LASIK surgeons lied to me and other 10 patients over and over. Why aren't doctors 11 reporting the truth to the public? If the FDA 12 followed federal law, lives can be saved. 13 Regarding the FDA not taking any 14 action to regulate LASIK centers as ASFs under 15 MDR regulation 21, CFR Part 803, LASIK surgery 16 centers meet the devices or facility 17 definition as an ambulatory surgical facility 18 or ASF. CFR 803 requires the FDA to regulate 19 LASIK centers, including their reporting and 20 written procedures. 21 What has the FDA done to inspect 22 any LASIK facility for written procedures or Page 20 1 for not making reports to the FDA to assure 2 that each LASIK center follows the ASF 3 procedures, like maintaining files and 4 reporting? 5 Will the FDA explain how they know 6 these LASIK ASFs are complying? Probably not. 7 What FDA surveillance program confirms that 8 LASIK ASFs are reporting adverse events that 9 occur in the ASFs to the FDA? Disclosing FDA 10 inaction in this public forum is shocking. I 11 am skeptical about the ability of the FDA's 12 CDRH to explain or defend its performance in 13 public. 14 I would not be surprised to learn 15 that few, if any, of these ASF centers meet 16 the requirements. LASIK is a surgery done on 17 millions of people. MDR regulation appearing 18 in 21 CFR 803 defines devices or facility 19 includes ASFs. I believe this encompasses 20 LASIK centers. 21 The types of adverse events and 22 serious injuries LASIK victims suffer from Page 21 1 must be reported by the ASFs to the FDA. 2 Annual reporting of MDR events can be 3 submitted on FDA Form 3419. 4 Publicize the FDA's lack of action, 5 please. If my suspicion is correct, the FDA 6 has been intentionally negligent in the 7 discharge of its responsibility to assure 8 compliance with the regulations. 9 Why have there been so few adverse 10 event reports to the FDA, despite numerous 11 consumer reports? By statute, ASFs are 12 required under penalty of law to report device 13 malfunctions. The reporting requirements 14 apply, regardless of clearance and approval. 15 I have presented the FDA with 16 evidence of unreported adverse events, but the 17 FDA did nothing. 18 Regarding bias in the LASIK 19 quality of life study, the AAO and NEI should 20 be involved, but ASCRS' involvement represents 21 an obvious conflict of interest. Researchers 22 should not already have drawn a conclusion Page 22 1 about quality of life and LASIK, not have a 2 financial interest in LASIK, or a bias. Yet 3 ASCRS is already announced three LASIK 4 surgeons for the study. 5 Regarding bias in the LASIK quality 6 of life study, the FDA knows there is a study 7 showing a connection between LASIK and suicide 8 -- Emory University. A significant 9 correlation between these two separate events 10 connects them. 11 The medical community should know 12 that LASIK patients may be committing suicide 13 at four times the expected rate. That's huge. 14 LASIK surgeon Dr. Richard Lindstrom has 15 financial interests in the device 16 manufacturers or the procedure, has already 17 drawn his conclusion about quality of life 18 after LASIK. 19 Having already stated his bias, I 20 believe he should not be allowed to design and 21 conduct a post-LASIK study in connection with 22 the FDA's post market review of LASIK. I ask Page 23 1 this Panel and the FDA, after submitting four 2 petitions: 1) to redo the FDA risk/benefit 3 analysis for LASIK; report the serious nature 4 of post market LASIK risks; include all the 5 post market risks like vision quality problems 6 and dry eye. We don't do anything to the 7 microkeratome in between eyes, say the 8 doctors. 9 2) For the FDA to regulate LASIK 10 centers as ASFs under existing FDA MDR 11 regulations. LASIK surgery centers meet the 12 device user facility definition as an ASF. 13 For the quality of life study to be 14 used, qualify professionals who are completely 15 independent of the LASIK industry; and 4) a 16 moratorium on the devices used for LASIK, 17 because LASIK surgery is far too risky and the 18 research was not ethically done. 19 5) Evaluate potential LASIK dry eye 20 treatments like unscented natural body butter 21 or those on mercola.com. 22 6) Stop LASIK. Page 24 1 Dr. Huang e-mailed me that there 2 were 12 patients with a single microkeratome 3 blade reuse. Dr. Huang is sitting on this 4 Panel. We do not need your expertise. We do 5 not need your conflicts of interest. 6 Say no to LASIK surgeons sitting on 7 any FDA panel evaluating devices used for 8 LASIK.