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.
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.
A spokeswoman for the
FDA’s
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:
"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:
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.
