These reports were asked to be returned because "There was too much information the general public should not be aware of" and "was not only applicable to the Nevyases' study, but all studies" (Quotes were from Les Weinstein, the Ombudsman of the FDA's CDRH division).
The FDA's Mission Statement: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
In light of media attacks on the FDA the past couple of years or so regarding drugs, I find it most disturbing nobody really ventures into the area of medical devices.
Specifically lasers used for LASIK. You hear so many advertisements about the 'good' of this procedure, what about the 'other side'?
Throughout this website I've explained what happened during the use of an Investigational Laser, and the results based on my experience. I've complained to the FDA since 2000 about my doctors' study, their laser, what happened to me, and everything in between. For the first 3 years, I've been bounced from 1 person/department to another, and it wasn't until December 2004, I finally got to have a conference with key personnel in the FDA CDRH's Office of Compliance, the Office of Device Evaluation, and the Ombudsman. Too little, Too late!
The results of the meeting basically was that the doctors did not damage enough people to warrant disciplinary action (such as LaHaye), and that their study was no longer going on.
They were generous enough afterwards to release via the Freedom Of Information Act (FOIA) documents relating to 2 inspections of their facility, edited of course.
Those reports were asked to be returned because "There was too much information the general public should not be aware of" and "was not only applicable to the doctors' study, but all studies". I was told in order for the FDA to help me, I must help them, by returning the inspection reports.
Where was the help when I needed it most? Like BEFORE I and others were subjected to be a guinea pigs!
The inspection reports although edited, should have added credibility to what I've been saying all along. I believe these reports, along with all of the other documentation showed that the doctors involved:
Deviated from standard of Care during the length of their investigational study.
Violated standards, protocols, and federal regulations during this time.
Submitted false documents to their Institutional Review Board (IRB), and the FDA, regarding outcomes, adverse event cases, and enrollment in their study.
Told patients to get them included into their study, in telling them they were 'good candidates', when in fact they were not.
Performed LASIK on HUNDREDS of people prior to FDA's approval for their IDE AND informed consent!
HOWEVER, months after receiving the inspection reports, documentation was submitted during discovery in the current litigation (which should have been produced during the med mal lawsuit) to prove the dates on the inspection reports wrong. How can the FDA offer protection to the people of the this country, when they make those kind of mistakes?
FDA Oversight of Clinical Investigators
From the Department of Health and Human Services Office of the Inspector General
Purpose: To examine the FDA's selection of clinical investigators for inspection and FDA's discipline of those clinical investigators found in violation of FDA's regulations. (June 2000)