The first sentence of a letter from a public relations firm representing a Beverly Hills ophthalmologist was dramatic and eye-catching enough.
"There is a 20-minute procedure that 'cures' myopia (nearsightedness)," it said, and it went on to promise miracle surgery that can permit someone who is nearsighted to "throw those glasses away."
Striking though it was, the letter received by The Times a few weeks ago was merely representative of a flood of pitches sent to the nation's news media in the last 12 months or so on behalf of doctors all over the country.
The subject of this promotional onslaught is a type of eye surgery called radial keratotomy in which the cornea--the eye's outer lens--is flattened by a series of microscopic incisions to bring an acutely nearsighted eye back to close to normal vision. In some cases, people with vision as out of kilter as 20/600 have realized correction to near the norm of 20/20.
Radial keratotomy's promise, however, remains unestablished in a scientifically consistent way, most experts agree. Even Dr. Paul First, who retained the public relations agency to bolster his radial keratotomy practice, now says he has some doubts about marketing claims being made for the surgery. First said the PR campaign yielded only about 25 patients and he has since severed relations with that firm.
"Some of the ads (and public relations pitches) I think (amount to) overmarketing," First said, conceding that the assertion made on his behalf that the operation can "cure" nearsightedness--technically called myopia--"is not a truthful statement.
"Some of the ads I've seen that say, 'throw away your glasses,' they're selling a dream and I guess that is what ads sell. On some people, the dream can come true, but it seems like that's not medicine--guaranteeing things."
The campaign on First's behalf was orchestrated by account executive Jane Summer of the firm of Boonshaft-Lewis Public Relations. She asserted that while she had not, in fact, shown the letter to First, she based its contents on conversations with First and other doctors who perform radial keratotomy. "I consider myself a person of integrity and I'm not in the business of hype," she said. Radial keratotomy is the object of a still-incomplete national study that recently reported results of the first year of its intended five-year inquiry. Preliminary though those results are, the controversy over the effectiveness of the procedure and how widely it should be performed has already prompted two federal court lawsuits by doctors who want to offer the surgery more widely and to have insurance companies reimburse them for it but who have alleged restraint of trade by other physicians who have labeled radial keratotomy "experimental."
A wide array of experts believe that radial keratotomy--for most nearsighted people--doesn't result in vision that is any better than what they already experience with glasses or contact lenses. In some cases, the vision may be worse--or at least not as reliably corrected. This is all at a cost of as much as $3,000 per eye.
All of this, however, has not been enough to prevent radial keratotomy from becoming an example of how the changing nature of medical practice and the increasing effects of economic pressure on doctors are combining to turn medicine into a profession in which marketing plays an ever-increasing role. Radial keratotomy, which many eye specialists still consider to be unproven and some still fear may lead to unanticipated long-term complications, has become one of the most promoted developments in medicine's recent history.
Dr. Byron Demorest of Sacramento, president of the American Academy of Ophthalmology, described radial keratotomy as "an alternative treatment for nearsightedness that can be offered or may be offered to any individual who is unable to tolerate glasses or contact lenses or who needs vision better than a certain level to qualify for a job."
Asked if the claims in the enthusiastic first paragraph of the letter sent out on First's behalf were true, Demorest chuckled for a moment, then said, "Of course not."
Demorest added in a telephone interview: "The problem is there is no predictability about the outcome and there still are some side effects. With this procedure, there's a question of the long-term side effects after five or 10 years. We honestly don't know. Some of the results (so far are) really encouraging, but it is still an evolving technique."
The still unfinished research on which the clinical future of radial keratotomy may depend is being sponsored by the federal government's National Eye Institute and involves a variety of respected centers across the country, including USC and ULCA. The study-- "Prospective Evaluation of Radial Keratotomy," or PERK for short--is seeking to follow several hundred nearsighted patients for at least five years to see if the operation makes good on its promise to correct nearsightedness without complications and for long periods of time.
PERK's first results were released at a meeting of the American Academy of Ophthalmology in Atlanta last November. The findings: 78% of the eyes on which the surgery were performed recorded vision good enough to qualify for a driver's license a year after the operation was performed.
For some radial keratotomy patients, according to the study still in progress, the surgery does, in fact, offer the promise of being able to discard eyeglasses. Still among the unknowns: long-term side effects of the surgery that may appear 10 or 20 years after the operation, and ways to predict how effective it will be on a specific patient before the operation is performed.
But even when radial keratotomy is completely successful, say a variety of prominent eye specialists, the surgery does not leave the patient with vision any better than what he or she could have enjoyed with well-fitted glasses or contact lenses. And radial keratotomy, for a variety of reasons, may leave a patient still needing glasses or having difficulty seeing at night, something never a problem before.
'If It Ain't Broke, Don't Fix It'
"I guess I believe in the old Georgia proverb, 'if it ain't broke, don't fix it,' " said Dr. Perry S. Binder, a La Jolla ophthalmologist and associate professor at the UC San Diego School of Medicine, who wrote an editorial appealing for reasoned assessment of the potential of radial keratotomy in a recent issue of a nationally known eye journal.
In a telephone interview, Binder observed that, for the average nearsighted patient, glasses and contact lenses work very well, indeed, and there should be no need to consider expensive surgery whose long-term effects are as yet unknown. Concluded Binder: "If a patient is seeing well with glasses and is satisifed (with his vision), why should he change?"
There are conflicting accounts of how radial keratotomy was developed. By some accounts, the theory behind it was espoused as early as the late 1800s. In the 1940s, a Japanese surgeon attempted incisions on the cornea, but the surgery led to catastrophic complications 10 to 20 years after it was performed, apparently because not enough was known at the time about the traumatic effects of surgery on the cornea that could be brought about by damage to the endothelium, a crucial layer of cells in the eye. The procedure was considered discredited.
Modern radial keratotomy apparently was first performed about 10 years ago in the Soviet Union and was brought to the United States in about 1977 by Dr. Leo Bores of Scottsdale, Ariz. Since then, Bores and several other doctors who make up a group called the Kerato-Refractive Society, have performed the surgery several thousand times. Dr. Ronald A. Schachar, a Denison, Tex., surgeon who is executive secretary of the society, said he has few doubts about long-term complications of radial keratotomy, despite the incomplete nature of the national PERK study.
Schachar contended there is no relationship between the disaster that befell patients who had the early Japanese surgery and people who undergo radial keratotomy today because of dramatic advances in the last four decades in understanding of eye physiology. "I have over five years of experience in my practice," said Schachar, "and if you ask me to predict, I'd bet 99.99% that nothing is going to happen to those eyes. I can tell you, the way I do the surgery, in 20 or 30 years, there won't be any problems."
Schachar also vigorously defended the predictability of the results of radial keratotomy. "This procedure is as predictable as anything you would measure in medical terms," he said. "Nothing in medicine is 100%. We can expect 90% of (radial keratotomy patients) to achieve 20/40 vision or better."
Apart from the debate over the long-term effectiveness of radial keratotomy, however, is a separate question of who should logically be considered a candidate for the surgery. Most eye specialists questioned by The Times agreed that glasses and contact lenses offer highly effective vision corrected for the nearsighted already.
But for two categories of nearsighted people, glasses and contacts are not the solution, these doctors say. Involved are patients who for some reason cannot tolerate glasses or contacts (allergies to contact lens cleaning chemicals are fairly common) or who are in professions--or seek to enter jobs--where vision must meet certain standards without wearing lenses at all. Examples often cited include firefighters, police officers, airline pilots and airline flight attendants.
For people who do elect radial keratotomy, there are certain risks that--at least for now--combine with the high costs of the surgery to make the operation inadvisable in the view of a broad range of specialists. One of these skeptics is Dr. Ronald E. Smith, of the USC School of Medicine and a member of the nationwide PERK research team. For one thing, said Smith, vision can change over time and a person who has radial keratotomy in his teens or 20s may find that his eyes change by the time he is 40 and he needs glasses, anyway, or must have repeated operations to maintain the correction provided by the first surgery.
Coping With Glare
Beyond that, said Smith and other experts, radial keratotomy patients sometimes experience problems coping with glare or seeing at night--difficulties that force them to wear glasses after all. There also are some reports of patients experiencing annoying fluctuations in their vision after radial keratotomy. Smith also suspects that a few radial keratotomy patients may suffer cornea damage that becomes a problem years after the surgery.
"We know that the cornea is in a weakened condition after this operation and, in some patients, it'll probably remain that way and that may make them susceptible to long-term damage," Smith said. He noted, however, that he is more enthusiastic now than he was before the PERK study released its first data last fall--findings that showed apparently few complications one year after surgery.
What concerns many doctors more than the debate over the technical and medical merits of radial keratotomy, though, is the marketing situation that has grown up around the surgery and its evolution into a controversy that has more of the trappings of an antitrust and restraint of trade dispute than a disagreement within the medical profession.
In 1980, the American Academy of Ophthalmology, following the lead of an advisory committee to the government's National Eye Institute, classified radial keratotomy as "experimental" surgery. It is a position to which the academy--the largest group within the eye care profession--has stuck ever since, even though many of its members would, inevitably, profit from performing the surgery if it is determined to be routine care for which insurance companies would pay.
The academy action brought first one antitrust suit--filed in U.S. District Court in Atlanta--and then another, filed in federal court in Chicago, in which doctors who advocate radial keratotomy have complained that initially members of the academy's board of trustees and later the organization as a whole had violated antitrust laws by seeking to interfere with performance of the surgery and inhibit payment for it. Specifically, radial keratotomy's backers have alleged violations of the Sherman Act and contend that the eye specialists' organization engaged in restraint of trade.
On Feb. 22, U.S. District Judge Robert H. Hall in Atlanta rejected a proposed settlement in the suit there in which an out-of-court accord would have called for the defendants to make some payment to the doctors who brought the action. Hall put off endorsement of the settlement on technical grounds, ruling that insufficient notice had been given to all parties. Another hearing will be held on the matter.
The Chicago action, in which the academy itself is named as a defendant, is still in its preliminary stages.
The litigation has become a backdrop for the ever-wider marketing of radial keratotomy by doctors across the country. Here in Southern California, some eye specialists have even taken to running television spots--some of which have promised a cure for nearsightedness. It is a campaign that has roused concerns in doctors on both sides of the legal disputes, not to mention many other physicians who are uninvolved in the litigation.
"I think there is a tendency for the patient to overestimate the ability of this operation to solve all of his visual problems," USC's Smith observed. "How much of this is in the mind of the patient and how much of this comes from the way it (radial keratotomy) is being marketed is anyone's guess."
Many doctors, moreover, see what is happening with radial keratotomy as only one symptom of a larger trend in medicine toward ever more marketing.
"The practice of medicine today has shifted to one of marketing, not only for radial keratotomy but to all aspects of health-care delivery," La Jolla's Binder said. "You're going to see more and more marketing and patients will have to try to ascertain who's providing the best-quality information with the best-quality service and find ways to eliminate the false and misleading claims.
"There is no certain way to do that."
Scapegoat in Broader Dispute
Schachar contended that radial keratotomy has become a scapegoat in the broader dispute over the appropriateness of marketing and promotion in the practice of medicine. "I think what has happened is that, because of the inappropriate calling of radial keratotomy as experimental, many physicians were reluctant to get involved," he said. "Now they feel they should have listened to their peers, who were telling the truth all the time (that the procedure is no longer only experimental in nature) and they have gotten active.
"When you talk about marketing, you have to realize that medicine is undergoing a revolution. Medicine is advertising all over. To use radial keratotomy as an example is inappropriate."