FDA LASIK Hearing

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In response to reports of widespread problems with LASIK, the FDA called a special meeting of the Ophthalmic Devices Panel on April 25, 2008.

Eye doctor says that LASIK is a terrible idea

Congratulations to Dr. MacKay for telling the public what most Ophthalmogists only tell to their own family members. Dr. MacKay tells her patients that LASIK is “a terrible idea and don’t go near it.”

ABC News: A Blurry Outlook for LASIK

At the hearing, medical doctors, optometrists, psychologists, and a number of injured patients presented compelling information establishing a causal link between LASIK complications, depression, and suicide. Several speakers called for an end to the procedure. FDA Patient Representative and injured LASIK patient, Paula Cofer, asked for stronger warnings in laser device labeling.

Lauranell Burch, Ph.D., discussed long-term consequences of LASIK, and urged the FDA to abandon the proposed LASIK quality of life study in favor of a study of post-LASIK dry eye disease and post-LASIK visual quality. Matt Kotsovolos, a LASIK patient who suffers from debilitating eye pain, presented data from LASIK clinical trials, which show that approximately 20% of patients report chronic dry eyes and persistent problems with night vision. Several speakers called for an end to the procedure.

FDA Lasik hearing

The FDA Ophthalmic Devices Panel hearing held in Gaithersburg, Maryland on April 25th, 2008. The hearing focused on LASIK quality of life, depression, and suicide.

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FDA Patient Representative and injured LASIK patient, Paula Cofer, asked for stronger warnings in laser device labeling.

Despite testimony of permanent adverse effects of LASIK that occur in all patients because they are inherent in the surgical procedure, Panel Chairman Jayne Weiss, M.D., a LASIK surgeon, concluded the meeting by blaming the problems on “some surgeons who should be doing a better job”, rather the surgery itself. Patients felt the hearing was a sham. In the five years since the hearing, the FDA has failed to respond to issues raised.

ASCRS and the FDA hearing

Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study. The timing of the press release seemed to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing. Patient advocates criticized the FDA’s partnership with the LASIK industry, comparing it to “placing the fox in charge of the hen house”.

These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK. ASCRS fired back at the North Carolina newspaper that broke the story in February, 2008. A flurry of bad press for the LASIK industry followed. By early March, the LASIK industry had launched its damage control campaign by releasing ‘preliminary findings’ from a LASIK literature review, which industry spokesmen asserted showed a 95% satisfaction rate. When the full text was published a year later, it was discovered that the authors concealed double-digit complication rates. This was exposed in a December 2009 article, long after the media had spread the misleading sound bite.

The FDA gave ASCRS 1 ½ years advanced notice of the planned public hearing on LASIK – enough time for ASCRS to conduct a “LASIK world literature review” and prepare talking points for the media. The spin generated by ASCRS surrounding this public hearing included misleading statements such as, “The FDA reaffirms that LASIK is both safe and effective”. At the hearing, Dr. Kerry Solomon, lead author of the literature review, was asked by FDA consultant, Jayne Weiss, M.D., for clarification concerning FDA’s role in ASCRS’ public statement and literature review. Solomon admitted, “This was independent from the FDA or the National Eye Institute. Yes, ma’am.”

Lasik Chronology Study

In response to complaints from LASIK patients, the FDA convened an “action team” in 2006 to conduct an assessment of post-market LASIK data. The team attempted to compare data that had surfaced since FDA approvals to the evidence upon which the FDA based its approval decisions; however, they found no scientifically sound basis for a comparison. As a result, the team recommended that the FDA evaluate post-LASIK quality of life in a clinical setting.

In November 2006, the FDA approached ASCRS and AAO about conducting a post-approval LASIK quality-of-life study, according to an article in Cataract & Refractive Surgery Today. This collaboration was not disclosed publicly until days before the FDA hearing.

As stated, in April 2008, two weeks prior to the FDA hearing, ASCRS issued a press release stating that the organization had formed a partnership with the FDA to conduct a prospective post-LASIK quality of life study. LASIK patient advocates complained to the FDA, accusing the agency of “placing the fox in charge of the hen house”.

After the hearing, months went by with no word from the FDA on the proposed study.

In October 2009, the FDA issued a press release announcing plans for a LASIK Quality of Life study with the National Eye Institute and the U.S. Department of Defense. To the surprise of LASIK patient advocates, there was no mention of ASCRS. (In February 2012, A LASIK industry publication reported that ASCRS, AAO, and the International Society of Refractive Surgery (ISRS) had walked away from a joint task force that was designing protocols for the FDA studies after their recommendations about how to respond to patient complaints were not followed.)

In October 2010, the FDA issued a second press release, stating that the second phase of the LASIK study, known as PROWL-1, would begin within the next three months at the Naval Medical Center in San Diego. LASIK patient advocates feel that by replacing ASCRS with the Department of Defense, FDA has simply traded one embarrassing collaborator with conflicts of interest for another.

Check the FDA LASIK Quality of Life Collaboration Project webpage for updates.

FDA Hearing Links