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

Diana Zuckerman, PhD PDF Print E-mail
Page 73

8 Hi. I am Dr. Diana
9 Zuckerman. I am President of the National
10 Research Center for Women and Families. We
11 are a nonprofit organization that is focused
12 on using research to improve programs and
13 policies that affect the health and safety of
14 adults and children, an we particularly focus
15 on FDA issues.
16 I am also a Fellow at the Center
17 for Bioethics at the University of
18 Pennsylvania.
19 I am trained in epidemiology at
20 Yale, and so I am going to use my scientific
21 perspective, not just -- I will be talking
22 about some of the research findings, but also

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1 to put in perspective all the individual
2 stories that you are going to be hearing
3 today, because it is that pattern that is
4 really very important and an important part of
5 epidemiology, not just the data.
6 I actually do want to start out by
7 saying that in my training as a psychologist
8 and an epidemiologist, there's a lot of
9 problems with self-reports, the kind of
10 subjective research that you have just heard
11 about.
12 The FDA's mission, as you know, is
13 to ensure the safety and effectiveness of
14 medical products. When we think about LASIK
15 surgery, we have to think of the context, and
16 that is that there are safe and readily
17 available and less expensive alternatives,
18 namely contact lenses and glasses.
19 Now it is clear, and it will be
20 even more clear as the day goes on, that there
21 are many patients that have been harmed by
22 LASIK. So the question is what are those

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1 benefits, and what are the risks?
2 There's very good information on
3 the FDA website about the risks, but who reads
4 the FDA website? So as this Advisory
5 Committee is looking and asked about what
6 should be on the FDA website, please keep in
7 mind and remind the FDA that there are other
8 mechanisms that are more effective at getting
9 information to patients than the FDA website,
10 and then product labeling.
11 Even though the FDA website has
12 good information, there are problems with it.
13 Parts of it are very difficult to navigate,
14 and particularly the parts that have to do
15 with individual devices, individual LASIK
16 devices. That information is really not
17 appropriate for patients.
18 It does not seem to be geared
19 toward patients, and even the patient booklets
20 that are available on the website and that
21 apparently are available through device
22 manufacturers are really not designed to help

Page 76

1 patients. They are much too long. They are
2 much too sophisticated in their use of
3 language, and frankly, they look like grad
4 student homework assignments.
5 So they are not really designed to
6 be read, because if they were, they wouldn't
7 start out with a rather complicated biology
8 lesson about the eye. So to be blunt, they
9 seem to be -- These patient booklets seem to
10 be designed to satisfy somebody at the FDA who
11 doesn't actually care whether any patient will
12 actually read or understand these booklets.
13 I want to conclude my remarks by
14 commenting on the questions that you are going
15 to be addressing today, because there are
16 several adverse reactions that really don't
17 seem to be part of those questions that you
18 are talking about, but they should be, and I
19 hope you will make sure that they are.
20 Most important is eye pain and dry
21 eye, which you have heard some about. Dry
22 eyes are the most common complication from

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1 LASIK. The most recent research shows that
2 half the patients have adverse reactions like
3 dry eye during the first week of surgery, but
4 that 20 percent persisted six months. And
5 these problems are more likely among women
6 patients and those with attempting higher
7 corrections.
8 Eye pain can be caused by dry eye
9 or it can come from other causes, but
10 whatever, it is terribly debilitating, and
11 these are serious complications that really
12 need to be included in the advice that you are
13 going to be giving today.
14 The need for additional surgery is
15 also very important, and something that has to
16 be studied appropriately. Research that was
17 just published this year in the American
18 Journal of Ophthalmology reported that 28
19 percent -- 28 percent of eyes corrected
20 through LASIK needed re-treatment within 10
21 years because of either under-correction,
22 over-correction or regression, and that is 28

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1 percent of the eyes, and it is even higher if
2 you look at the patients. It is 35 percent of
3 the patients. That's a very high percentage,
4 and patients need to have that kind of
5 information before they make any kind of
6 decisions.
7 The possibility of a higher suicide
8 rate among patients has been raised, and will
9 be raised. More research and really good
10 quality objective scientific research is
11 needed.
12 I tried to get that information. I
13 contacted Emory University, but was not able
14 to get better information about that research,
15 which has not been published.
16 Overall, patients do not seem to
17 have informed consent when they have LASIK
18 surgery --
19 CHAIRPERSON WEISS: Would you be
20 able to --
21 DR. ZUCKERMAN; Yes, I will.
22 CHAIRPERSON WEISS: Thanks.

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1 DR. ZUCKERMAN; Part of the reason
2 is lack of data, but it is also because, as we
3 know, health professionals tend to focus on
4 the consent part of informed consent, not the
5 informed part.
6 Informed consent is a process. It
7 is not a piece of paper. Even the best --
8 will be undermined if -- agree with what is
9 there. So I hope that you will address
10 informed consent today, and I'm happy to
11 answer any questions.
12 CHAIRPERSON WEISS: Not at this
13 time. Thank you very much.