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.

best oem software

  • Cheap and Discount OEM Software Online software store oem software store

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

Rebecca Petris PDF Print E-mail
Page 176 

7 Thank you very much
8 for the opportunity to speak.
9 I used to be a commercial jet
10 finance specialist. I left that career a few
11 year ago because of problems I suffered from
12 LASIK, chronic pain from dry eye and reduced
13 vision.
14 I started several years ago a small
15 nonprofit organization for people with
16 complications of laser eye surgery. It is
17 called Laser My Eye.
18 Dry eye quickly emerged as the
19 leading problem that we were facing from
20 people seeking out help. As a result of that,
21 I went on to start a company called The Dry
22 Eye Company to try and find more resources for

Page 177

1 people with dry eye.
2 That company runs a number of
3 informational websites for people with dry eye
4 syndrome. A large percentage, of course, of
5 the people that come there are suffering from
6 severe dry eye after LASIK, seeking out help.
7 One of the things that we do is
8 collect little known products that can help
9 people with dry eye that they are not learning
10 about from their doctors.
11 I missed the deadline to request a
12 speaking slot here, because I was too busy
13 working with these patients that are looking
14 for help after LASIK. I took a Redeye here
15 from Seattle last night, because I could not
16 tear myself off the phone.
17 I spoke yesterday morning with a
18 man in Arkansas for about an hour and a half
19 who was suicidal. He was three months post-op
20 from LASIK, and what he kept telling me was,
21 Rebecca, why didn't anybody tell me this could
22 happen? Why didn't anyone tell me how bad it

Page 178

1 could be? They told me I could get dry eye.
2 It was on the form. I understood, but they
3 said we'll give you some drops, we'll give you
4 some plugs; it will be okay, and it will
5 probably go away quickly.
6 I get these kinds of calls every
7 day, all day long. The vast majority of my
8 time is spent speaking with patients who are
9 going through this, not three months after
10 surgery, but six months, 12 months, three
11 years, six years after surgery, people who
12 have done everything and been everywhere.
13 They have traveled to national and
14 international experts, and they have not found
15 remedies, and I don't have answers for them.
16 There's been a lot of talk here
17 today from the industry saying we care, but I
18 am not seeing the compassion. I want to see
19 it.
20 There are a lot of doctors here
21 today. I wish they could be flies on the wall
22 of my office during the day, hearing the

Page 179

1 wreckage of the patients' lives and their
2 families' that are just looking for help.
3 I agree with the presenter that
4 said that depression and anxiety and suicide
5 are not -- they don't come from a single
6 factor, not just from the fact that they had
7 LASIK, absolutely not.
8 It is because they did not get
9 proper informed consent. They went through
10 the surgery. They did not get treated
11 properly afterwards. They wandered from
12 doctor to doctor afterwards. No one
13 understood their problems. They haven't had
14 solutions to the problems that they are
15 facing, financial problems.
16 They are facing a host of factors,
17 all related to the LASIK. It is not about the
18 20 minute surgery. It is about what came
19 before and about what has come after it. It
20 is the lack of solutions for them.
21 Few people understand that dry eye
22 pain after LASIK can drive people absolutely

Page 180

1 to distraction. I can't tell you how many
2 people I know are on short term or long term
3 disability now because of this kind of pain.
4 They need help.
5 If the industry were interested in
6 helping, if they are interested in helping,
7 they need to rally around the consumer groups
8 that are looking for help. They need to come
9 to us with practical solutions to help. Plugs
10 and drugs are not doing it for us.
11 We've got people we talk to that
12 have been everywhere. They have volunteered
13 for every clinical trial going. They are
14 scrounging together anything they can to just
15 hold it together from day to day.
16 I don't organized notes for
17 presentations for you today. I am simply
18 overwhelmed with the need. I feel like triage
19 nurse with all these people coming, seeking
20 help, for whom I just don't have enough
21 answers, and that is what I am here for today,
22 just to appeal to you for help to prevent more

Page 181

1 of this, and to help us get solutions for the
2 people that are facing problems from LASIK.
3 Thank you for giving me the time.