March 20, 2008

LASIK Critics Feel Shunned by FDA

Info on Hearing is Scarce, Patients Say
Sabine Vollmer, Staff Writer

As federal regulators prepare to hold their first hearing on how complications from laser eye surgery affect a patient’s quality of life, patients are worried that they are being shut out.

The Food and Drug Administration has said it will hold a public hearing on the issue this spring, but patients who have requested to speak at the event cannot get  confirmation from the FDA on the date, time or location, said Michael Patterson, a lasik patient from Atlanta.

However, at least one laser eye surgeon who is working with the FDA to collect patient information plans to report his findings at an FDA meeting April 24-25.   And Dr. Richard Lindstrom, co-chairman of the group of surgeons collaborating with the FDA, said his group hopes to have three surgeons testify.

“The April meeting is shaping up to be a major hearing,” he said. Lindstrom also is president of the American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery.

The FDA has yet to publish meeting details in the Federal Register. Until it does, it is barred from making the information public, FDA spokeswoman Karen Riley wrote in an e-mail message.

The FDA’s response to patients’ requests for permission to speak, including his own, has Patterson worried that “the FDA is going to listen to the doctors, not the patients.

“It shows a lack of respect for patients,” he said.

Patterson experienced debilitating complications after his lasik surgery in August 2000, including dry eye, vision distortions and floating debris. His petitions to more closely scrutinize lasik — which stands for laser-assisted in situ keratomileusis — prompted the FDA two years ago to take another look at the medically unnecessary surgery, which is only loosely regulated.

Since the mid-1990s, numerous studies have suggested that the surgery is safe and successful in most cases and has become more so with the introduction of new technology.

The American Society of Cataract and Refractive Surgery has estimated that 2 percent to 3 percent of lasik patients experience complications, which typically resolve themselves in three to six months.

FDA statistics and other research indicate that complications, which can include chronic pain, dryness of the eyes and distorted night vision, may be much more frequent and longer lasting.

Takes a toll on patients

Patient advocates have long argued that the existing research is at best incomplete, because most studies do not evaluate how complications from lasik can affect patients’ lives.

At least one suicide has been linked to complications from lasik, bolstering patient advocates’ position that unremitting eye pain or impaired vision can exact a severe emotional toll.

Laser eye surgeons are willing to learn from patients’ experiences, Lindstrom said: “We need to understand the negatives.”

The first step is a review of 19 studies measuring patient satisfaction. Dr. Kerry Solomon of the Medical University of South Carolina’s Storm Eye Institute said he plans to report first results of the literature review at the FDA’s April meeting.

Of about 2,000 patients who participated in the 19 studies, an average 4.8 percent were not satisfied with the outcome of their laser eye surgery. In the study with the lowest satisfaction rate, more than 12 percent of patients were unhappy. The study with the highest satisfaction rate had no dissatisfied patients.

Patient satisfaction is a broader measurement than the complication rate, Lindstrom said. “It captures patients who objectively have a good outcome, but they’re not happy,” he said.

Patterson and other patient advocates disagree, saying that approach blames the patient rather than the surgery.

The toll from lasik complications is very real, Patterson said. And no matter how inconvenient regulators and surgeons make it for patients to argue that point, he said, “they’re not going to be able to shut us out.” or (919) 829-8992

Posted by Admin at March 20, 2008 08:25 PM