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 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.
