The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.


FDA Continues Inadequate Protection! PDF Print E-mail
Wednesday, 03 June 2009 11:06

Michael Patterson
[Redacted]

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 complications are:
17.5% halos?
19.7% glare?
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).
 

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