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

Gerry Dorrian PDF Print E-mail
Complete FDA Transcript of Mr. Gerry Dorrian's Presentation

Page 37 10 My name is Gerard 11 Dorrian. I have no financial interests in any 12 LASIK-related entity that I know of. 13 Can everyone hear? Oh, this one is 14 on. I'm sorry. 15 My name is Gerard Dorrian. I have 16 no financial interests with any LASIK-related, 17 anything that I am aware of. 18 I am here to tell the story of my 19 son, Colin. Before Colin had LASIK surgery, 20 he was a very confident, outgoing person. 21 There was no sign of any mental illness. He 22 had never been diagnosed with mental illness, Page 38 1 didn't use illegal or recreational drugs, and 2 he seldom drank. 3 This is a picture of Colin at his 4 graduation from Cooper Union with a degree in 5 engineering. As you can see, he wasn't much 6 more than a child. 7 It was a number of months after 8 this that he had LASIK surgery, while he was a 9 law student at the University of Michigan. 10 Before the surgery, he had become intolerant 11 to contact lenses, because of dry eye. This 12 is his justification for getting the surgery. 13 He has large pupils. There's other technical 14 information for all the medical people here. 15 When he was assessed for this, he 16 was warned that his large pupils would be 17 something to consider, but was told that it 18 was no worse than he would experience with 19 contacts. It is actually noted on the medical 20 forms that I found after his death, that there 21 was less than one percent chance it would be 22 worse. Page 39 1 This is information about his 2 treatment. After the treatment, Colin 3 experienced large starbursts. He said he had 4 triple overlapping images and ghosting off 5 white objects, and he said that he lost 6 contrast sensitivity. 7 He also complained about dry eye, 8 and that made it impossible for him to 9 tolerate contact lenses. Three times, he 10 tried to be fitted with contact lenses, but 11 couldn't wear them. 12 This is Colin again, and it's 13 difficult to do this, but I think the thing 14 that best explains where Colin was is to read 15 the last words he left for us: If I can't get 16 my eyes fixed, I am going to kill myself. At 17 the time of this writing, I have lived for six 18 and a half years like this, and it drives me 19 more and more crazy every single day. For a 20 while, I coped fairly well and have gone 21 forward with things I had to do; but this 22 problem has kept me from enjoying life the way Page 40 1 I used to. Every single thing I look at, more 2 or less throughout the entire day, looks ugly 3 and confusing to me. I just cannot accept the 4 fact that I am supposed to live like this. It 5 may not make much sense to someone who has not 6 experienced these symptoms, but I am rotting 7 from the inside out. I have other problems, 8 like most people do. In fact, I might tend 9 toward the depressive side naturally. Who 10 knows? But this is something else. As soon 11 as my eyes went bad, I fell into a deeper 12 depression than I had ever experienced, and I 13 never really came out. I could get down about 14 things before, but I always had my health to 15 rely on. Without that, just getting by is not 16 enough. I can't continue living without my 17 responsibility, my esteem and my happiness. 18 There is nothing at all ennobling or 19 enlightening about suffering. The more I live 20 with this problem, the more it will warp me 21 and the more hateful and bitter I will become. 22 I refuse to picture myself starting a family Page 41 1 that I won't be able to enjoy and love because 2 one mistake has so damaged me mentally and 3 physically. It seems reasonable at this point 4 to say that, if this problem doesn't get 5 resolved by the end of the summer, it never 6 will. I've put up with this this long, 7 because killing myself would be such a blow to 8 those who love me. But I can't and won't 9 continue facing this horror anymore. I am 10 sorry for that. I am sorry for what I've done 11 to you guys, my family and friends, but I have 12 been living with this long enough and I have 13 gone over and over it in my head long enough 14 that I accept and forgive myself for my 15 mistakes, and I hope you guys can do the same 16 for me at some point. If it seems to have 17 come out of nowhere, know that I have been 18 keeping my counsel on this for a long time. I 19 was incredibly afraid that, if anyone found 20 out how badly I was feeling, my only escape 21 would be cut off, and I couldn't risk having 22 what I feel is my only dignified choice taken Page 42 1 away from me. I obviously never meant for 2 this to happen, but after the first mistake, I 3 don't know that there is anything else I could 4 have done differently to change things, and I 5 absolutely know there is nothing you guys 6 could have done differently. You may have 7 trouble following this request, but I am 8 asking that you do not blame yourselves for 9 this. I made a choice six years ago, and I 10 lived with that choice for as long as I could, 11 until one day I decided I simply couldn't take 12 it any longer. 13 Mom, Dad, Nora and all the rest, 14 know that I enjoyed the bulk of my life, 15 mainly because you were in it. I love you 16 all. I'm sorry, and goodbye. 17 These are purely my observations as 18 a layperson. I feel that people that are 19 involved with refractive surgery need to take 20 responsibilities for the problems they create, 21 not just point to the successes that they 22 have. Page 43 1 I don't think a patient 2 satisfaction survey, no matter how you dress 3 it up or what else you call it, really gives 4 anyone any information about how people are 5 suffering. It doesn't illuminate what happens 6 to people who have bad outcomes. 7 Colin said that it wasn't just a 8 matter of what his high order -- 9 CHAIRPERSON WEISS: Mr. Dorrian, 10 you have -- you are very, very compelling. 11 Thank you very much. 12 MR. DORRIAN: Thank you. 13 (Applause.)