Subj: U.S. Seizes Contraband Eye Lasers
Date: 97-06-09 19:50:27 EDT
From: AOL News/AP News
BCC: Eyeknowwhy

.c The Associated Press
WASHINGTON (AP) - Government agents seized over $3 million worth of eye lasers from a Florida company Monday, the Food and Drug Administration announced, saying the company was selling unapproved machines to operate on nearsighted Americans.

U.S. marshals seized nine excimer lasers from Photon Data Inc. of Winter Park, Fla., the FDA said.

Photon Data officials did not return a phone call seeking comment.

The FDA said it was beginning a crackdown on doctors and companies that offer the popular surgery for nearsightedness with lasers that the government has not certified are safe and effective.

The FDA has approved two lasers, made by Summit Technology and Visx, to help sharpen patients' vision. Anyone considering eye-laser surgery should ask their doctor if the laser being used is made by one of those firms, the FDA warned. If not, the patient should then ensure that the laser is part of an FDA-sanctioned clinical trial, the agency said.

Photorefractive keratectomy, or PRK, uses a blast of intense light to reshape people's corneas so they can see better at a distance.

The FDA said it has received a handful of reports of patient injuries, including permanent eye damage and the need for a corneal transplant, after operations with unapproved lasers. To learn just how many people are at risk, the agency urged patients and health care workers to report such laser problems by calling 1-800-FDA-1088.

Last year, the FDA uncovered doctors importing cheaper, used lasers from Europe or building their own instead of buying the approved equipment, which costs about $500,000. The government at that time ordered them to stop, but Monday's seizure marked the first legal action.

Photon Data did not have FDA approval that its lasers were safe or effective enough to sell, nor had it filed an FDA application, said Dr. Bruce Burlington, the agency's medical device chief.

AP-NY-06-09-97 1844EDT

Questions arise in study about cataract surgery

SACRAMENRO, Calif. (June 11, 1997 00:20 a.m. EDT, TOM PHILP, The Sacramento Bee) -- As a young Air Force pilot, Gerald Ashcraft's eyes were plenty sharp for 52 bombing missions. As a retiree, life began to get blurry. The Nevada County resident went to a doctor, who recommended cataract surgery.

Cataract surgery is the single biggest cost for the federal Medicare system. Chances that a senior citizen undergoes the surgery, it turns out, vary dramatically depending on how the doctor gets paid.

The procedure involves the removal of the eye's internal lens, which has become cloudy, and replaced with a plastic one. Success rates are typically more than 90 percent.

Senior citizens like Ashcraft in the traditional Medicare system, in which a doctor gets paid for every procedure, have twice the cataract surgery rate than those enrolled in health maintenance organizations, according to a California study in Wednesday's Journal of the American Medical Association.

The study doesn't answer the central question for consumers -- whether Medicare HMOs are performing too few cataract surgeries or traditional Medicare doctors too many.

Yet the research adds to a growing body of evidence that the payment system for doctors is a powerful force in shaping the medical care received by the nation's elderly.

"Money speaks," said Dr. Robert Brook, head of the health sciences program at the RAND Corp. and a co-author of the study.

About a third of senior citizens in Sacramento County have abandoned the traditional Medicare system to join an HMO, one of the highest rates in the nation.

The migration to the Medicare HMOs is expected to increase both here and throughout the nation as Congress looks for ways to limit the rise in Medicare costs in an effort to balance the federal budget. This change is taking place, however, without researchers such as Brook knowing how it will affect the health care actually received by the elderly.

"This study raises a red flag," said Dr. Caroline Lubick Goldzweig, an assistant professor at UCLA and lead author of the study.

Goldzweig tracked the eye care received by more than 111,000 Southern Californians. About 47,000 were in traditional Medicare and 64,000 in HMOs, which cooperated in the study on the condition of anonymity.

Senior citizens in the Medicare HMOs typically receive some benefits beyond the traditional system, such as limited drug coverage. Yet to help the HMO control its costs, they are limited as to which doctors they can see.

To see an eye specialist, for example, senior citizens typically would have to see a "gatekeeper" doctor first.

Goldzweig said she expected to find differences in the rate of the cataract surgery -- but not as much as she found. "I was surprised by the magnitude of the difference," she said.

In 1993, the HMO doctors performed cataract surgery at a rate of about 24 procedures per 1,000 Medicare enrollees. In fee-for-service Medicare, the rate was about 57 per 1,000. The cost in 1993: $3.4 billion.

In 1995 America's doctors performed 1.4 million 584 cataract procedures on senior citizens in Medicare, according to the medical journal. Concerned that doctors have excessively performed the procedure to increase their incomes, federal officials have instituted reforms over the years, such as publishing guidelines outlining when the surgery is appropriate and lowering cataract fees to doctors.

"Ten years ago, I was reimbursed (from Medicare) $1,515 for cataract surgery. Today I am reimbursed less than $1,000," said Dr. Robert Griffin, a Sacramento ophthalmologist who sees senior citizens in traditional Medicare as well as those enrolled in HMOs.

"I think there are some incentives in fee-for-service medicine that encourage doctors to perform elective surgery a little sooner than may be performed under a managed care environment," said Griffin. "There is no evil intent in either environment." Deciding who needs the surgery can be "very subjective," he said. Under traditional Medicare, "there was so much fraud in cataracts, it was unbelievable," said James Robinson, a health economist and professor at University of California, Berkeley. "It was a Wild West kind of environment."

As for the 77-year-old Ashcraft, who had cataract surgery five years ago, "I'm very happy with it," he said. He is wary of joining an HMO. "They're so rushed," he said of the doctors.

When senior citizens learn of studies such as these that point to differences in surgery rates, "they are going to say that HMOs are denying care," Robinson said. Yet researchers aren't ready to draw that conclusion.

"I don't think we know yet," said Goldzweig. "We don't know yet what is the appropriate rate (for cataract surgeries). One expert blasted Goldzweig's study for not trying to answer that question. "The study doesn't examine the issues that are really important," Dr. Stephen A. Obstbaum, president of the American Academy of Ophthalmology, told the New York Times. "We don't know the health of the individuals who did or didn't have the surgery. We don't know, if surgery was delayed, what the outcome was."

Scientifically proving that some surgeries were inappropriate, or that others didn't occur when needed, involves far deeper sleuthing in medical charts, said Goldzweig. "It really pushes us to answer these quality questions," she said.

ATC Recommendation for Approval News Releases

ROCKVILLE, Md., Feb 13 (Reuters) - A Food and Drug Administration advisory panel on Friday voted unanimously in favor of approving the LADAR Vision laser system made by Autonomous Technologies Corp.

"The presentation was very complete and compelling," said panelist Joel Sugar.

The panel said the surgery was safe and effective, but recommended that it be limited to patients over the age of 21. It also said the laser should be used to treat a narrower range of nearsightedness than the company requested.

The FDA generally follows its committees' advice.

LADAR technology was originally developed for the Star Wars defense initiative in the 1980s and was adapted for eye surgery, said Autonomous Technologies CEO Randy Frey.

The narrow-beam laser uses radar to guide surgeons, allowing more accurate shaping and cutting of the eye's lens. Even if a patient's eye moves slightly, LADAR keeps the surgeon on track.

In studies of 884 patients who had nearsightedness or nearsightedness with astigmatism, 93 to 95 percent had their vision corrected to 20/40 or better six months after surgery. Fifty to 60 percent had correction of 20/20 or better.

A majority of patients were very satisfied and only two to three percent needed second surgeries to correct their vision.

There were few side effects. A small number of patients had problems with foreign bodies in their lenses, but the company said it had figured out how to minimize that problem.

" ... First, the system was recommended for approval to treat up to eight diopters of nearsightedness and up to four cylinders of astigmatism rather than the 10 diopters and six cylinders sought by the company. Diopters and cylinders refer to levels of severity. In addition, the product was recommended for approval for patients age 21 and over, rather than 18 and over as had been sought by the company. "

From Federal Filings:

" However, the panel reviewer (Mark Bullimore) said that the benefits of the eye tracker function on LADERVision was not proven and asked the FDA to prevent the company from placing a benefit claim on the label. Bullimore said that this claim would require a comparison trial with a PRK laser that does not contain a tracker. "

"Analysts estimate that approximately 400,000 laser eye vision correction surgeries will be performed in the U.S. during 1998 at a cost of approximately $2,000 per eye. The laser manufacturers generally receive about $400 per procedure. "

AAO News Release Regarding PRK Safety

SAN FRANCISCO, Feb. 3 /PRNewswire/ -- Most of the first patients to undergo excimer laser photorefractive keratectomy (PRK) are still enjoying the benefits of the procedure and suffering virtually no ill effects six years later, according to a study to be published in this month's issue of Ophthalmology, the Journal of the American Academy of Ophthalmology.

The study, by researchers in London, traced 83 British patients who underwent the first round of PRK procedures in 1990. Those then-revolutionary procedures were performed at St. Thomas' Hospital in London as treatments for mild to moderate myopia (nearsightedness).

The researchers found that the degree of refractive correction, which had been evaluated up to nine times in the three years following PRK, remained essentially stable from the one-year mark to the six-year stage. The number of patients that remained close to the intended level of correction ranged from 91 percent among the least myopic to 19 percent in the most myopic, but none of the regression occurred after the first year.

The researchers also found no sign of complications (such as cataract, retinal detachment, or elevated intra-ocular pressure) in any of the 83 patients -- and none had ever developed infection. The patients who had complained of corneal haze in the year following PRK reported that it had faded over the years, although a small number complained of still having night-vision "halos." The findings confirm what shorter-term studies have determined -- that PRK is a safe and effective method of treating myopia.

SOURCE American Academy of Ophthalmology

AP - Claims To Beware in Eye Ads

.c The Associated Press

By The Associated Press

Watch out for extravagant claims in advertisements for surgery to correct nearsightedness, farsightedness and astigmatism, warns the American Academy of Ophthalmology, the U.S. Food and Drug Administration and the U.S. Federal Trade Commission.

From the academy's brochure and Internet Web site, some claims to take cautiously:

``Throw away your glasses!''

``See naturally with refractive surgery!''

Studies indicate that 95 percent of photorefractive keratectomy patients have 20/40 vision or better, and two-thirds get 20/20 or better. But there's no guarantee you won't be among the unfortunate 5 percent, and your own doctor's failure percentage might be higher.

Even if your vision is 20/20, you'll eventually need reading glasses -- and studies have found that refractive surgery may speed up that date for some patients.

``98 percent of our patients see 20/40 or better postoperatively -- good enough to pass a driver's license exam in most states!''

Ask to see the study or analysis on which that claim is based. Note that 20/40 may not be good enough for clear distance vision or driving at night.

``Achieve permanent vision correction with refractive surgery!''

The operations are still relatively new; the FTC objects to claims of permanence, saying the long-term data is too scant to back them up.

``PRK surgery is safe and painless.''

Not so. There is usually some pain and discomfort, longer for PRK than for LASIK. Doctors usually give patients extra-strength painkillers.

AP - Laser Eye Surgery a Booming Market
.c The Associated Press

By JANET McCONNAUGHEY

NEW ORLEANS (AP) -- Catherine Wilson has finally adjusted to her contact lenses and to carrying around two pairs of reading glasses, a year after laser surgery on one of her eyes.

The surgery took away her midrange vision. ``Nobody told me that I wouldn't be able to see the food on my plate without glasses,'' she said.

When the surgery doesn't work, your vision is worse for life. Problems with the increasingly popular surgery are the topic of a symposium at the American Academy of Ophthalmology meeting, which opens today in New Orleans.

Most of the time, the procedure works. Success stories are a big part of the reason that the number of operations has grown from more than 100,000 in 1996 to 200,000 last year and 380,000 or more this year, said Elias Vamvakis, chief executive of The Laser Center chain of eye surgery clinics.

Federal approval of laser surgery for farsightedness has just added 70 million potential patients to the 90 million or so nearsighted people in this country.

The operations -- photorefractive keratectomy, or PRK, and laser in-situ keratomileusis, better known as LASIK -- cost $1,500 to $2,750 per eye. Ninety percent of patients get both eyes done. Insurance generally doesn't pay, considering it cosmetic surgery.

In PRK, the beam of laser light sculpts a thin layer off the surface of the cornea. There can be a long period of discomfort because the affected surface remains exposed to the air.

With LASIK, the laser works on an underlying layer exposed by that tiny flap. Afterward, the flap is put back in place to protect the treated surface. While there is less discomfort, there is more chance of infection.

Faye Galland wore contacts for 15 years, until her eyes refused to accept them any longer. Although she was skeptical about eye surgery, she finally changed her mind after paying $400 for her latest pair of glasses.

``I just decided that once in my life, I wanted to experience being free,'' she said the day of her operation.

For the first time in about 40 years, she could see without glasses or contacts. ```I sometimes wake up and jump up, and everything's easy,'' she said. ``It's not fuzzy.''

Ms. Galland can't remember the last time she saw her face in a mirror without glasses: ``That's the downside. There's no hiding any more.''

Before her PRK, Mrs. Wilson wore contacts or glasses for severe myopia, with one pair of reading glasses. Now she needs two sets -- one for books and one for the computer.

If she goes to the store, she has to switch them for labels and signs.

``I'm a lot worse off than before,'' she said.

Responsible doctors tell patients that there's no guarantee of 20/20 vision, and that almost everyone will eventually need reading glasses. But they also can point to studies showing that vision is corrected to 20/20 for three-quarters of all patients.

Bloomberg - Visx, Autonomous Technologies Lasers Win FDA Nods

Washington, Nov. 3 (Bloomberg) -- Visx Inc. and Autonomous Technologies Corp. won separate U.S. Food and Drug Administration approvals for their laser devices to help correct vision.

Visx, one of the pioneering makers of eye lasers, said it won FDA clearance to add farsightedness to the list of vision problems that can be surgically corrected with its laser. The company's laser is now the only one cleared to treat the full spectrum of vision problems in a booming laser surgery market.

``It opens up a vast market for them,'' said John Rooney, an analyst with Hornblower & Weeks Inc. ``It will be a head start above all the other laser companies,'' he said at the time of a July hearing where an agency advisory panel recommended the laser procedure be approved.

Separately, Autonomous Technologies said it won FDA approval to sell its LadarVision System to treat nearsightedness and astigmatism. The approval brings the still money-losing company into a market dominated by Visx.

Autonomous Technologies may be helped by an agreement with Summit Technology Inc., another major eye laser maker. On Oct. 1, Summit said it agreed to buy Autonomous for $86.6 million in cash and stock.

Shares of Santa Clara, California-based Visx rose 6 1/2 to close at 54 1/4. Shares of Orlando, Florida-based Autonomous fell 1/2 to close at 4 9/16, while shares of Waltham, Massachusetts- based Summit rose 1/4 to close at 4 3/8.

Lasers made by Visx and Summit are already approved for treating nearsightedness and astigmatism. The approval for farsightedness would clear Visx to sell software equipping its existing laser devices with the ability to do the new correction.

The devices sell for $400,000 to $500,000 and Visx charges a $250 commission from doctors for the software cards for every laser operation.

After an initial slow start, the laser vision correction market has taken off as doctors become more comfortable with the procedure and as companies -- led by Visx -- roll out improvements offering flexibility in what kinds of vision problems may be corrected.

A majority of all Americans require vision correction, and spend more than $13 billion annually on glasses and contact lenses. The industry estimates that 37.5 million Americans are prime candidates for laser vision correction.

Expanding Uses

Although Summit was the first laser company to win an FDA approval for the eye surgery, Visx dominates the market now -- in part because it has pioneered an ever wider range of approved uses for the devices, analysts and company officials say.

About 22 percent of all Americans have some form of farsightedness according to the U.S. Census Bureau. The condition accounts for one in every three or four visits to the eye doctor, experts said.

Lasers now are approved in the U.S. for flattening out the cornea -- the clear window of the eye that sits over the pupil -- to correct most forms of nearsightedness and for correcting astigmatism. The delicate procedures cost patients about $2,500 an eye.

In the case of farsightedness, a different strategy is required where doctors use the laser to whittle down the outer edges of the cornea, creating a steeper curve to bend and focus light correctly.

Nidek Co., a closely held Japanese company, and Bausch & Lomb Inc. are closest to bringing their laser products to the U.S. market, experts say. LaserSight Inc. has a single laser approved for use in the U.S. at one sight, and sells similar products internationally.

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