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

Dominic Morgan PDF Print E-mail
Ladies and Gentlemen:

My name is Dom Morgan. I am legally blind from 
my surgeons’ improper use of an investigational
laser, a laser sanctioned by the FDA, known to 
be responsible for damaging over 30 people. I had
Retinopathy of Prematurity, meaning that my 
retinas were structurally incomplete at birth. 
I was 20/50 and barely legal to drive when I had LASIK. 
I was never a candidate. The intraocular pressure 
created by the suction ring destroyed my retinas. 
My problems are permanent. As retinal problems 
they will never be addressed by a contact lens. 
I believe my doctor knew and did the procedure anyway. 
I was dropped from their clinical study. So were others. 
Those data were never reported to the FDA. The doctors 
sued me because I set up a website and told the truth.

I've addressed my concerns about LASIK to the FDA for 
over five years, not only on my behalf, but also on 
behalf of others. In 2003 I filed a petition regarding 
medical devices and safety of refractive surgery, which 
was ignored. Help was offered by Ombudsman Les Weinstein, 
and then retracted.

My concerns today are with those needlessly damaged by 
refractive surgery. Even with the most modern technology, 
there are still of too many people writing me telling of 
the nightmares they now live with on a daily basis. I 
received several hundred emails this past year from people 
seeking help. Many of those are depressed. Some of them have
confided that they want to commit suicide. And this is just 
through one website. Having corresponded with many of
those patients, I believe they are just ordinary people cause 
in unusual circumstances. There is nothing remarkable about them, 
certainly nothing to suggest perfectionism, or any of the other 
reasons that some LASIK doctors use to excuse their own bad results.

The FDA's capacity to oversee the refractive surgery industry 
is in my opinion no different than the doctors who have 
tarnished it. The FDA has been ineffective in overseeing 
investigational studies, ineffective in enforcing the policies 
mandated for the industry, and ineffective in providing thus 
far the protection that many of us here today should have had.

Everyone in this room today is here for a reason. Please 
do not allow what is presented to you to continue falling 
on deaf ears. The public must depend on government agencies 
like the FDA to protect them.

In a recent press release, ASCRS volunteered to contribute 
funding for the FDA study on LASIK complications and quality 
of life. The FDA has already received copious amounts of 
criticism because of funding received from the pharmaceutical 
industry. Essentially, industry funds the FDA, which creates 
conflicts of interest. I ask the panel how funding received 
from ASCRS is any different. Most of the patents who have 
emailed my website feel deceived and lied to by surgeons who 
have exploited the public perception that doctors are healers. 
Why should damaged patients trust an organization of such 
surgeons any more than they trusted their own surgeon?

Included with my submission today I would like to emphasize 
are two letters previously written to the FDA, which are 
already public record. These letters apply not only to me, 
but many others:

The letter written by Dr. Steven Friedman to the FDA’s 
Office of Criminal Investigation summarizes not only my 
experience and I believe the outright criminal activity of 
my doctors, but also explains why the civil justice system 
does not work.

The letter written by Dr. James Salz, respected LASIK 
surgeon and principal investigator for past FDA studies 
emphasizes that I was not a proper candidate for LASIK and 
tells why.

Also included are a few documents and previous correspondence 
I sent to the FDA. I believe this further supports what I just 
outlined.

My story and more can be found at lasikdecision.com.

I ask the panel to recommend to that FDA conduct its own 
independent and unbiased study: Survey damaged LASIK patients 
nationwide and ask how many feel lied to by their LASIK doctors. 
Conducted without funding from the industry, the results might 
be believable.

I would also ask that the Criminal Division of the FDA conduct
investigations of specific doctors such as mine, in regards to their
actions in dealing with many of us.

I think a moratorium on advertising by doctors is an intriguing ideal 
as well. So much is made on patient selection but more should be done
on doctor selection. Maybe a website listing doctor qualifications
in a standardized verified format.

Thank you for your time and I will gladly post any presentation 
unedited on my website.

Also included with Mr. Morgan's submission were inspection reports
that were obtained via the Freedom of Information Act (FOIA) from
the FDA. Mr. Morgan states the reports were asked to be returned to them 
by Ombudsman Les Weinstein because they were not redacted enough and showed 
"too much information the general public should be aware of".