In the United States, the Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety of drugs and medical devices. But can you really trust the FDA? The agency has a long history of approving drugs and devices that were later found to cause serious injury and even death. Many FDA-approved products have been withdrawn from the market or recalled by the agency.
Manufacturers of refractive surgery lasers ‘cherry-pick’ surgeon-investigators for clinical trials — only allowing leading surgeons to participate. In turn, investigators cherry-pick patients, including only those who are likely to have a good outcome. For this reason, clinical trials do not reflect outcomes that are seen in the real world of ‘average surgeons’ and ‘borderline candidates’.
“I think we have to be careful about this ‘best physicians’ talking about lack of data. I’m sure these were good docs and good surgeons, but creating this extra god-like category, I think we should take out of the discussion.”
– Dr. Jayne Weiss, Consultant & Panel Chairperson
“That’s a point well-taken. Nonetheless, I mean, we hardly expect better performance in the field than we do in a clinical trial.”
– Karen Bandeen-Roche, Ph.D., Consultant
“You don’t have data to support that statement, do you? Do you have data to support that statement? You do. Okay.”
– Dr. James McCulley, Consultant
“With all kinds of devices.”
– Dr. Ralph Rosenthal, FDA
“Deep capture” occurs when a regulatory agency, created to act in the public interest, instead advances the interests of the industry it is charged with regulating. For many years, critics of the refractive surgery industry have accused the FDA of being ‘captured’ by organized ophthalmology. When former FDA scientist, Dr. Morris Waxler, began speaking out against LASIK, he stated that the FDA approved LASIK devices in an environment of enormous pressure from prominent ophthalmologists who worked hand-in-glove with FDA reviewers. James Dickinson, FDA watchdog and editor of FDAWeb.com, opined in a 2010 letter to LASIK patient advocate, Dean Kantis, that he had researched the LASIK controversy and found an inappropriate relationship between the FDA and the American Society of Cataract and Refractive Surgery (ASCRS), a professional organization of LASIK surgeons.
Want to know what happens when FDA scientists blow the whistle on corruption inside the agency that leads to dangerous medical devices being cleared. Read New York Times article
The FDA is required to monitor a medical product’s safety in the U.S. market after approval. One way the agency does this is through its Medwatch program.
Facilities that provide refractive surgery are required to report injuries to the laser manufacturer or to the FDA; however, non-compliance is common. Consumers may voluntarily report adverse events to the FDA through MedWatch; however, the public is generally unaware of the program.
Several thousand adverse events related to LASIK have been reported to the FDA since 2008. Many of these reports involve permanent vision loss. The majority of reports voluntarily submitted by patients involve night vision problems and chronic dry eyes. Diminished quality of life is frequently reported as associated with these problems.”
In 2009, the FDA inspected a number of LASIK clinics for compliance with the reporting requirement, and issued warning letters for noncompliance. It is well known that regulated industry frequently does not take FDA warning letters seriously, and that the agency lacks sufficient resources and motivation to diligently prosecute all who fail to take the letters seriously. We believe that very few LASIK clinics report adverse events.
Since 2003, eight citizen petitions* have been filed asking the FDA to take action to address problems concerning the use of LASIK devices. These petitions have gone unanswered or have been denied.
The FDA held a public hearing in 2008 to discuss issues concerning post-market experiences with LASIK. Although medical doctors, optometrists, psychologists, and injured patients presented strong arguments against the procedure, the FDA has not restricted the devices or strengthened warnings in the device labeling.
Since 2008, several letters and countless emails have been sent to the FDA by injured LASIK patients and patient groups asking for a variety of responses and actions to protect the public from LASIK devices. The FDA has been unresponsive.
In November 2009, a letter with 126 signatures of concerned citizens was sent to the FDA calling for the agency to issue a public health advisory regarding risks and long-term adverse effects of LASIK surgery. The agency has not responded accordingly.
Furthermore, the FDA has ignored the alarm of thousands of LASIK injuries contained in its MedWatch database (MAUDE). As stated, these reports represent only a small fraction of the true number of injured LASIK patients, as LASIK surgeons ignore the reporting mandate and injured patients are not aware of the program.
*You may view citizen petitions on regulations.gov. Enter Docket ID: FDA-2003-P-0349, FDA-2006-P-0088, FDA-2006-P-0347, FDA-2006-P-0075, FDA-2006-P-0277, FDA-2007-P-0116, FDA-2008-P-0319, FDA-2009-P-0253, and FDA-2011-P-0022.