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

Dean Kantis PDF Print E-mail
Complete FDA Transcript of Mr. Kantis' FDA Presentation

Page 24 11 Good morning, FDA 12 Panel, honored guests, and fellow victims of 13 the flawed and unpredictable LASIK eye 14 surgical procedure. 15 My name is Dean Andrew Kantis, 16 founder of lifeafterlasik.com. For the past 17 nine years, I have spent $30,000 seeking 18 restoration of my ruined vision, only to find 19 out there is no cure. 20 Through my website, hundreds of 21 victims have contacted me expressing their 22 suicidal thoughts. Some have already Page 25 1 committed suicide. It is always the same 2 story: I was lied to. The name says it all, 3 "lay-sick, lay-sick." 4 When I began to speak out against 5 LASIK years ago, I encountered a severe 6 backlash. Even my own doctor, Nick Caro, St. 7 George in Chicago, tried to sue me for $2 8 million for exposing his 40 law suits. He 9 then caused my family to get a divorce last 10 year by harassing my wife, attempting to her 11 fired from her nursing profession. 12 My family has been harassed, has 13 had death threats, and was lied to by this 14 doctor. Yet no one has punished him for his 15 actions. Where was the FDA? 16 How is it that a doctor in this 17 country can have forty-plus law suits with no 18 known disciplinary action? I feel that my 19 second-opinion doctors also lied to me, and I 20 know they are the problem. 21 How is a patient ever able to find 22 out they have a problem if all the follow-up Page 26 1 doctors lie to protect the original doctor? 2 Where was the FDA? 3 After submitting complaints in 4 these same doctors' department of regulations 5 in Florida and Chicago, backed by solid 6 evidence, I soon found all were denied. They 7 all went up to probable cause, and there at 8 the top sits a medical doctor in order to 9 cover a fellow doctor. I feel like I have 10 been raped. 11 Because of the lies, I was unable 12 to sue my doctor before the statute of 13 limitations ran out. I guess that is why they 14 all kept telling me that it would take three, 15 maybe four, maybe five years, Dean, for you to 16 fully heal. Sound familiar? 17 I had to go online to find out the 18 truth. I am now out of pocket for medical 19 expenses, lost wages and for daily suffering. 20 I don't know of any other procedure where 21 hundreds of patients have created websites 22 warning the public about the unpredictability Page 27 1 and corruption of LASIK surgery. 2 I have outlined five key emerging 3 points which should be thoroughly investigated 4 by this Panel to ensure that the LASIK 5 industry does not continue to dupe the 6 misinformed public. 7 Number 1: What is the truth about 8 the flap and the pupil size? I was told that 9 the flap created heals like a cut on your 10 hand, but the truth is the flap never heals. 11 Isn't that right? It is unpredictable, and 12 leaves the patient with a permanently scarred 13 cornea for life to see through. My pupils 14 were measured off the charts at 9 millimeters. 15 Yet my doctor told me I was the perfect 16 patient candidate for LASIK. 17 Just remember, today's happy 20/20 18 LASIK patient may regress and be tomorrow's 19 LASIK casualty driving a school bus picking up 20 your children. Oh, yes, it affects everybody 21 in this room. 22 Number 2: What is the true Page 28 1 informed consent? I have submitted a complete 2 pamphlet to this Panel that gives the patient 3 true informed consent with full color pictures 4 illustrating the known side effects. 5 Please consider mandating this 6 pamphlet, for yours is antiquated. Then 7 educate the consumer on the statute of 8 limitations, so they know the time frame to 9 sue their doctor starts from the date of the 10 procedure, not from the date of discovery. 11 The line LASIK doctors all know this. 12 Number 3: What constitutes a LASIK 13 success? I see double vision, halos, 14 starbursts, fluctuating vision, dry eye 15 syndrome. Yet I was told I was a success. 16 Can you believe that? 17 In order to believe the LASIK 18 industry's reported satisfaction rate of 95 19 percent, you must accept these complications 20 to be acceptable normal outcomes. That's the 21 question. Do you believe a patient who has 22 these problems to be a success, because the Page 29 1 LASIK industry does. 2 Shouldn't patient success be 3 decided by each individual patient, however 4 they define success? How does this Panel 5 define success? 6 Number 4: What is a breach of the 7 standard of care for LASIK doctors? The FDA 8 has stated over and over that it is not their 9 job to discipline doctors. Then whose job is 10 it, because nobody seems to be doing it? 11 I am out of a life that I once 12 enjoyed, because money came first. My well 13 being came last. I ask this Panel to hold the 14 FDA responsible for reviewing the ambulatory 15 code, 21 Charlie-Foxtrot-Romeo 803.17, 16 requiring all LASIK facilities since 1997 to 17 report all adverse patient outcomes. 18 I feel every LASIK facility in this 19 country is in violation of this mandatory 20 requirement, which should prompt a class 21 action law suit. 22 If the CDRH has not even bothered Page 30 1 to check the LASIK centers in their own 2 neighborhood, why do they, all of a sudden, 3 set up visionsite.net as a new initiative for 4 their own incompetence? I do hope the media 5 here today will run with this and investigate 6 this. 7 Lastly, number five: What are the 8 unforeseen emotional consequences of LASIK 9 that affects every LASIK doctor, their family 10 members and patients? 11 I come today at my own expense 12 after eight years of research to inform this 13 Panel that you have a serious problem on your 14 hands, a very desperate, suicidal and angered 15 patients that know their LASIK doctors lied to 16 them and blame their LASIK doctors for ruining 17 their precious lives. 18 I ask this Panel to set up an 19 emergency hurt LASIK patient fund immediately 20 in order to help patients with suicidal 21 preventive therapy, ongoing medical expenses, 22 legal representation, and lost wages. Page 31 1 Please take immediate action to 2 protect the people who are under your care and 3 pay you for protecting them. Thank you.