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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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
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
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
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:
This is not the FDA Lasik site. The FDA Lasik site is here. Instead, this site was created to expose deceit, corruption, and collusion by the FDA and the LASIK industry. You've read the hype about the ten minute miracle. Now get the truth.
Former FDA Chief of Medical Devices, Morris Waxler, PHD, Warns Public About Dangers of
LASIK - Aired February 25th, 2010 on Good Morning America
Leave it to the FDA to deny that they ‘MESSED UP’. Mr. Waxler admitted 10 years after his retirement what most LASIK casualties have been trying to say since the late 1990s. The FDA continues to downplay the risks further allowing more people to get damaged from this procedure - when is enough enough? At least Mr. Waxler has taken his time to actually talk to damaged patients on a personal level (myself included), which is more than I can say for the FDA. I commend Mr. Waxler for his honesty.
Could LASIK Lead to 'Permanent Vision Problems'?
FDA Must Stop 'Epidemic of Permanent Vision Problems,' Former
A former Food and Drug Administration official who helped get the
vision correction surgery LASIK approved back in the 1990s but later spoke out
against the procedure is taking his concerns directly to current regulators at
Morris Waxler, who is now an independent regulatory consultant,
filed a citizens petition today urging the agency to take steps to stop what he
calls "the epidemic of permanent vision problems" caused by LASIK.
Waxler's petition implores the FDA to take actions to crack down
on the procedure, including issuing a public health advisory that warns the
public about the dangers associated with LASIK and implementing stricter
controls over LASIK device manufacturers and practitioners who perform the
In the petition, Waxler included data that he said were evidence
that "LASIK causes persistent vision problems with an overall success rate of
less than 50 percent; a failure rate of more than 50 percent."
Waxler said his change of heart came about after he retired from
the FDA in 2000. He started getting complaints from people who suffered serious
side effects from the procedure, including seeing halos, impaired night vision
and excessive glare.
He was surprised when he looked back at the data presented when
LASIK was undergoing the approval process in the late 1990s.
"When I looked back at that data, there was a tremendous
consistency that show these problems exist in about 18 percent of people who had
LASIK, most of them after I left the FDA," he said.
Some doctors, however, say while they agree with the estimate
that thousands of people have had problems after having LASIK surgery, they
stress that the vast majority of people are very happy after having the
"Ninety-nine percent of people who have had LASIK have excellent
results," said Dr. Robert Cykiert, clinical associate professor of ophthalmology
at NYU Langone Medical Center. "Millions of people have had the procedure done
with a high success rate."
Doctors, Patients Say LASIK Procedure Is
Safe and Effective
One of those satisfied patients is Andy Ng of Long Island,
Ng had LASIK in 2004. He decided to go through with the
procedure because he got tired of spending hundreds of dollars on glasses that
needed special lenses and would get banged up because of his participation in
sports. He also found contact lenses cumbersome and time-consuming.
He said he already knew about the side effects before he went
in for the surgery.
"I knew for a fact I was going to have halos at night," Ng
said. He added that aftewards, the halos didn't make much of a difference for
"I have no other problems, such as floaters, dry eyes, etc.,"
Doctors stress that LASIK is no different from any other
medical or surgical procedure.
"We always would like to have any medical procedure or
surgical procedure that works 100 percent of the time, but that doesn't exist,"
"Complications do happen, but it's rare, and often, we're not
sure why," said Dr. Penny Asbell, professor of ophthalmology at the Mount Sinai
School of Medicine.
Doctors also say that even if a patient is an ideal candidate,
the surgeon is very skilled and the equipment is top-of-the-line, problems can
still occur, so it's difficult to predict whether someone will suffer from LASIK-associated
Communication, Information Vital to
Minimizing LASIK Risk
Not everyone is a candidate for LASIK, and doctors say it's
important for prospective patients to understand that. People with vision that
continues to get worse, extremely poor vision, certain characteristics of the
cornea and some diseases may not be suitable candidates for the procedure.
"Doctors need to take time with a patient and get all the
information they need," Asbell said. "Doctors also need to learn what the
patient's expectations are. If a person wants 20/15 vision, they may not be the
Experts also say there are still things about LASIK that they
just don't know.
"It's very hard to quantify these side effects, such as
determining how to measure how bad things like glare and halos are," Asbell
said. "It's hard to pin down risk factors that differentiate the people who have
problems from the ones that don't so we can try to learn more."
"There are many things we still don't know about the cornea,
such as physiology and variability in structure, so we don't know why some
patients bounce back and others don't," Cykiert said.
Cykiert also said that the thousands of people who have
problems have a legitimate reason to complain to the FDA, and that information
they provide can be helpful for everybody.
"That's how we're going to make the procedure safer and
better," he said.
And that's also how there may eventually be more people like
Andy Ng, who has no complaints about his LASIK experience.
"The procedure is one of the best things out there for the
eyes," he said.
AT LEAST SOMEONE FDA RELATED HAS A CONSCIOUS!
April 2008 FDA Ophthalmic Panel Meeting
April 25th, 2008 was a historic day for the Food and Drug Administration. On that day, a number of medical doctors, optometrists, psychologists, and injured patients presented at a Special Hearing of the Ophthalmic Devices Panel, responsible for the approval of medical devices for ophthalmic use in the United States. The subject of the hearing was post-LASIK quality of life, depression, and suicide.
Insiders acquainted with the FDA approval process for medical devices were horrified as one by one, the presenters alleged deception by individual LASIK surgeons, cover ups perpetrated by medical device manufacturers, and corruption at the level of the FDA itself. Compelling cases were made for massive violations of federal law, the failure of the FDA to monitor surgical facilities for LASIK, and deliberate misclassification of severe complications as simple side-effects, as a means of securing premature FDA approval of the excimer laser.
The mass media attended and filmed the April 25th hearing. Nevertheless, the substance of the above allegations went mostly unreported, despite the presentation of four completed post-LASIK suicides, including excerpts from two actual suicide notes (these presentations are included in the videos at right). The American Society of Cataract and Refractive Surgeons (ASCRS) asserted that individuals with psychological issues post-LASIK certainly had psychological issues all along. To anyone without a preconceived bias, the ASCRS position seemed indefensible. Still, the mass media focused on a 95% percent satisfaction rate, a statistic put forward by ASCRS, but not yet published in their own peer-reviewed literature. Why?
Fortunately, the entire event was captured on video. Moreover, FDA transcripts are considered government documents, and as such, are not subject to copyright laws. Beyond the obviously sad assocation between severe LASIK complications, depression, suicide, and medical deception and corruption, the April 25th Special Hearing of the Ophthalmic Devices Panel must be regarded as one of the most interesting sociological dramas in modern medicine, one which is still being played out. This site chronicles the events leading up the meeting, including press releases by the American Society of Cataract and Refractive Surgeons (see here and here), videos by presenters on both sides, and the reaction of the American press.
Judge for yourself the significance of these events, and come to your own conclusions about LASIK, the industry behind it, and the FDA.
Weiss Opts for Glasses
Written by Administrator
Sunday, 15 June 2008 08:18
Dr. Jane Weiss chaired the Ophthalmic Devices Panel meeting in Gaithersburg, Maryland on April 28th, 2008. Press releases issued by ASCRS before the hearing stated that the "FDA confirms that LASIK is safe and effective." Yet, Weiss clearly opts for glasses. Perhaps it's good enough for the public, but it's not good enough for Dr. Jane Weiss.
Last Updated on Sunday, 15 June 2008 08:25
FDA Continues Inadequate Protection
June 1, 2009
Daniel Schultz, M.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Dr. Schultz:
Please respond to this letter on or before June 15, 2009 so I can address this
issue in any government briefings scheduled for June. In my opinion, the fact
that the FDA is out of compliance is very important to the decision-making
process of the patient. There is a vast difference between "safe, approved and
monitored" versus "approved but unmonitored, unreported, and unknown".
On July 22, 2008, you wrote a letter to me regarding LASIK issues and safety
concerns. You stated that presentations given by injured LASIK patients at the
April 2008, Ophthalmic Devices Panel meeting made you "keenly aware" of problems
I and others experienced.
In that letter, you stated that the FDA would be implementing changes "as soon
as possible". I recognize the updates to the FDA LASIK website and other
activities including Timothy Ulatowski's 5/22/2009 letter to Eye Care
Professionals concerning LASIK advertising. In the thirteen months since the
hearing, however, I have not seen any substantive changes and the inhumane
breaches of the FDA regulations continue status quo. This is unacceptable.
Please address the issues below and why another FDA petition has Not been
answered more than one year after it was properly filed with the FDA (see
attached Exhibit 3, FDA-2008-P-0319-0001, and http://www.lasikcomplications.com/Citizen-Petition-to-Ban-Lasik.pdf).
Is it true that none of the FDA clinical trials used by the FDA to approve the
lasers meet the FDA’s own criteria for approval? Is it true that even after the
“healing period” of six months that the percent of patients reporting
19.3% night driving problems?
21% dry eyes?
5% severe dry eyes (e.g., Cataract & Refractive Surgery today June 2008)?
As you are undoubtedly aware, the FDA continues to endorse (and fund) a plan to
conduct a prospective quality of life after LASIK study in collaboration with
biased LASIK surgeons who have clear financial conflicts of interest and who are
under pressure from members of their professional societies to improve their
LASIK profits. Yet none of the representatives of the LASIK study have contacted
a single LASIK victim or Doctor representative who spoke at the FDA panel
meeting in April 2008.
In fact, when I recently contacted the NIH to participate in this FDA funded
LASIK study, I was told there are no studies regarding LASIK at all (but there
is one on Dry Eye). Where did the funds that were spent on this LASIK study go?
I ask the FDA to clarify where the millions of dollars supposedly spent on this
study to date have gone and which LASIK Doctors received the funds and how the
taxpayers benefitted (if at all).
A recent letter (see attached Exhibit 1) seeking a moratorium on LASIK devices
to members of the House Committee on Energy and Commerce, Subcommittee on
Oversight and Investigations and other congressmen addressed concerns about the
FDA "putting the fox in charge of the hen house" in the proposed study. A group
of LASIK victims (PhDs, MDs, etc) has offered to conduct a study for $50,000 to
$100,000 total via a nonprofit organization and only asks the government to help
obtain access to the patients (as required for any study).
Reports of LASIK complications to the FDA's MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).
Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events. In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.
The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that "Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients." Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK's approval.
The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that "The FDA reaffirms that LASIK is both safe and effective." LASIK critics have responded to this assertion by asking publicly "When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?"
Three other sources of information suggest collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA's website were encouraged to use a comment form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA Center for Devices and Radiological Health (CDRH), but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single MedWatch report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.
Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that "The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR...does not provide timely and usable data to staff or other system users...[and]...has a large backlog of reports which hampers the ability to detect signals or identify problems." Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK comment form never counted?
Third, according to an article in the June 2008 issue of Cataract & Refractive Surgery Today, in November 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and American Academy of Ophthalmology (AAO) to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA's intention to call a Special Hearing for LASIK post-market issues. In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?
Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.
Last Updated on Wednesday, 24 September 2008 03:32
Human Geneticist and Biochemist Lauranell Burch has filed a petition with the FDA to ban LASIK. If you have complications from LASIK, you will want to comment. Be sure to include any deception in how LASIK was sold to you, inadequacy of informed consent, denial of your problems by your surgeon and second opinion surgeon, your vision immediately after your surgery and your vision now, and any feelings of depression and suicidal ideation, since these are common in patients with severe complications. You can comment here.
Due to enormous public outcry, the FDA is at last formally receiving general comments on LASIK here.
NOTICE:The FDA is currently assisting the LASIK industry in its medical coverup by censoring many patient comments to the petition, in clear violation of Federal Law. If you do not see your comment reflected, you now know why.
You know Big Pharma, now Meet Big Lasik
The pharmaceutical industry has pushed new drugs on physicians and an unsuspecting public for years, while covering up risks and failures, often with the implicit cooperation of the FDA. What you may not realize is that many medical device manufacturers are now doing exactly the same.
One of the most lucrative markets for medical devices is laser eye surgery, also known as "Big Lasik." According to the LASIK industry and the FDA, the popular eye surgery is both "safe and effective." If this is true, then why are there so many patients with complications? Why do so many patients want to commit suicide because of bad LASIK?
Dr. Michael Mullery: "The refractive surgery industry has known since it's inception that LASIK surgery carries a risk of depression and suicide..."
Dr. Terrilyn Bankes: "I fail to understand how the ophthalmologic community can defend the continuing production of life altering complications, and I view it as a true disgrace of modern medicine."
Edward Boshnick, OD: "I feel at the present time LASIK presents a significant public health crisis."
David Hartzok, OD: (Presented by Glenn Hagele) "The loss of visual quality reduces patients' overall sense of well-being and leads to depression and chronic anxiety."
Roger Davis, PhD: "While Director of Research, we submitted a study on depression and suicidal thoughts to a major refractive surgery journal. Among 58 patients admitting suicidal ideation, 83 percent stated they were told they were a success by their surgeon.
Diana Zuckerman, PhD: "Research that was just published this year in the American Journal of Ophthalmology reported that 28 percent -- 28 percent of eyes corrected through LASIK needed re-treatment within 10 years...
Michael Patterson, PhD: "The FDA states safety was determined with a risk/benefit analysis, but where is it? Make the formal risk/benefit analyses public. ...Quality of vision and Dry Eye risks were not evaluated. I believe no risk/benefit analysis was actually done.