In Washington, D.C., a culture that embraces regulatory oversight and rule-making and where bureaucracies are everywhere, no federal agency is more warren-like than the Food and Drug Administration, which regulates the safety and efficacy of food, pharmaceuticals, cosmetics and medical devices.
The health and well-being of every American depends on the FDA’s rigorous collecting, sifting and interpreting of data to approve products ranging from those that cure nail fungus to devices that electronically zap the brain to relieve anxiety. FDA regulators are scientist bureaucrats who tirelessly navigate the tedious but essential world between reports and medicine in a poorly lit building with very narrow hallways. They do important work, but FDA scientists don’t always get it right.
This is a story about one scientist haunted by what, he fears, was a bad decision. Between 1996 and 2000, the scientist, Dr. Morris Waxler, was chief of the FDA’s Diagnostic and Surgical Devices Branch and in charge of approving the LASIK medical device to restore visual acuity. And now, Waxler thinks that the FDA’s standards were not tough enough. In 2008, an FDA advisory panel was urged by unhappy patients to re-evaluate the long-term effects of LASIK surgery and around the same time, patients began contacting him personally to report bad outcomes, including blurred and double vision.
The FDA authorization process for medical devices in the United States requires several levels of review before a product is approved. The rigorous process is centered in Waxler’s old Diagnosic and Surgical Devices branch, a part of the Center for Devices and Radiological Health that regulates manufacture, packaging, labeling and import of medical equipment as well as radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
In the early 1990s, the LASIK equipment fell under FDA review. For sufferers of myopia, corrective eyeglasses and contact lenses had long been a remedy for their impaired vision, but this new apparatus and method used laser beams to remodel the eyeball in a way that purportedly allowed patients to “throw away their glasses.” The heat and precision of the laser device made the short outpatient procedure relatively painless and assured such a short recuperative period that patients barely had to miss a day of work.
LASIK — which is neither a trademark name nor a franchise, but the acronym of a surgical method, “laser-assisted in situ keratomileusis” — seemed miraculously easy, even though it involved a scary-sounding and delicate procedure. (It entails slicing a thin, hinged flap on the front surface of the cornea, a surgeon lifts the tissue up and, using ultraviolet excimer laser beams, reshapes the eye before folding the flap back over the cornea). Well-heeled professionals then turning 40ish, (an age in which human sight weakens), were drawn to what seemed like a medical miracle of rejuvenation. Laser eye surgery, when done correctly on appropriate candidates, painlessly turned terrible vision to nearly perfect.
In 1995, the FDA approved the first laser-assisted system for refracted surgery and by 1998, the FDA had approved mass manufacture of the laser devices. LASIK centers opened up as prices, originally several thousand dollars per eye, came down. Although health insurance claims departments typically disallow the procedure as “elective,” medical providers found diagnosis codes to coax claim compliance. Shopping centers sprouted LASIK clinic chain stores and baby boomers lined up. For the ophthalmic profession, LASIK correction surgery was like a gold rush. By 2008, 12 million patients had undergone the procedure in the United States at an average cost of $1,500 to $2,100 per eye. Over 700,000 people have the surgery every year.
The device had, after all, been vetted as safe and effective by Waxler’s team back in 1995. The government scientists had relied on information provided by the laser device manufacturers and ophthalmologists assuring them that the radial keratotomy procedure was safe and effective. The FDA rules required LASIK to undergo several phases of medical trials (7,830 patients participated in clinical trials from 1993 to 2005) to ensure it did not harm patients and indeed worked as hoped for.
When an item is finally approved and marketed to consumers, there are often reports of “adverse events.” (Adverse can mean everything from a rash to a death.) This happens even if the medical technology company provided complete and accurate information in its approval application. When too many adverse events happen, however, the FDA will often order a recall.
But in the months and years after LASIK became ubiquitous at 25-year class reunions, stories of eye damage and subsequent depression, even suicides, surfaced. The surgery can, it turns out, induce dry eyes, halos, light sensitivity, night blindness, ghost images, keratectasia (corneal thinning and bulging) and many other serious damaging effects.
In the nearly 10 years since he left the agency, Waxler, (now a regulatory consultant who has stayed involved in FDA product approvals) has come to particularly regret the LASIK decision. Unusual for a former regulator, particularly for someone with business before the agency, in 2010 Waxler went public with criticism about FDA’s approval standards. A year ago he went on “Good Morning America” and told correspondent Lisa Stark, “I did the best we could … but in hindsight it wasn’t good enough.” He heard more stories that suggested when people complained to their eye doctors, their adverse effects were not reported to the FDA. The FDA issued a statement to ABC News that it considered “LASIK lasers to be reasonably safe and effective when used as intended,” but has launched a two-year study to take a closer look at side effects.
Last May, Waxler became more persistent. He considered LASIK eye surgery complications “already a major public health problem” and he said so in a letter to the ophthalmic organization, American Society of Cataract and Refractive Surgeons. He told the organization’s president the group was presenting data for a safety study in an “unethical” manner. The association president responded in September that the former regulator’s letter was “misinformed, unsupported by evidence, and lacking in balance and perspective.”
Waxler again appeared on ABC News in September claiming “half of LASIK patients experience side effects.” A committee of well-regarded LASIK experts (R. Doyle Stulting, M.D., P.h.D.; George O Waring III, M.D.; James J. Salz, M.D.; James McCulley, M.D.; Douglas Koch, M.D.; Jayne Weiss, M.D.; and Marian Macsai, M.D.,) responded to Waxler’s claim: “We believe he has no reputable basis for such a claim since he did not produce the scientific evidence.”
Finally last month, Waxler filed a formal citizen’s petition to his former government employer requesting the FDA withdraw approval for all LASIK devices and to issue a public health advisory for recalling the equipment. The industry is working on newer models and newer methods so nearsighted consumers will still be able to get their vision remodeled (insurance companies still won’t pay for it, probably). Since it was filed, the petition has been reposted on the Internet by numerous supporters.
In his petition, Waxler says manufacturers and also “clinics, refractive surgeons, and agents withheld and distorted safety and effectiveness data” and, he alleges, “in a classic example of the fox guarding the henhouse,” the “collaborators” routinely hide reports of LASIK injuries from FDA by settling lawsuits out of court. He also claims that equipment makers have “cherry-picked, withheld, and hid data from FDA” that he believes show LASIK with “excessive adverse event” rates of 22 percent. Waxler also submitted “confidential information” on the matter to FDA’s criminal investigation arm.
The FDA has not yet commented publicly about Waxler’s petition but an FDA spokeswoman told Politics Daily “it is a citizen’s petition and we will review it.” Waxler told Politics Daily that the LASIK experts have not commented either.
Written by Bonnie Goldstein, and originally published in The New York Times, February 10, 2011.
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