The Marketing of Lasik: Buyer Beware

Steve Arshinoff, FRCSC: "I read the editorial on advertising in ophthalmology with great interest and wholehearted agreement. The seemingly progressive tendency to irresponsible advertising, particularly of laser in situ keratomileusis (LASIK), is becoming an embarrassment to all of us who wish to practice ethical medicine and do no harm to our patients". Source: J Cataract Refract Surg. September 2004. LASIK advertising: We should not sell procedures.

Remember when the law prohibited doctors from advertising? The intent was to keep the profession pure, to ensure that healing was its foremost virtue. This is no longer true. Refractive surgery represents a profound threat to the core values of medicine. Most patients with complications say that they were never adequately warned. This page looks at what happens when doctors become businessmen.

H. Dunbar Hoskins Jr., MD, American Academy of Ophthalmology Executive Vice President: "In medicine our role as professionals is to put the patient's interest ahead of our own. Professional societies have had ethical standards that underscore the importance of that principle. Historically this went unquestioned. It was a medical need that caused the patient to seek out the physician. .. Now this principle is being tested as we see increasing efforts to attract or even entice patients into practices. This is a continuation of an activity that began with cataract surgery some 10 years or so ago. It is the nature of a competitive marketplace. It also sends a strong message to the consumer: 'Let the buyer beware'."
EyeNet Magagine, June 2000 LASIK Advertising Is Testing Our Professionalism

"Francis W. Price, MD: "It's a shame. I'll lay it all on the government and the lawyers. They gave doctors the right to advertise".
EyeWorld, March 2001, LASIK "experts" advertise, annoy established surgeons

What are the ways in which advertising can deceive patients?
Douglas D. Koch, MD: "Ads imply that the result will be perfect, permanent, and/or complication free. Examples include "20/20 for $2995" or "20/20 promise" or "quick and pain-free way to eliminate your need for corrective lenses."... "In my view, an even more repugnant approach is the "money back guarantee." This implies that the procedure is somehow reversible and that there are no potential risks of sight-threatening or sight-disturbing complications. Getting one's money back does not make up for a lifetime of unhappiness about one's vision; it is not like returning a broken television." Journal of Cataract & Refractive Surgery, August 2003 LASIK Reporting: Preserving our responsibility to our patients

"Be wary of eye centers that advertise, '20/20 vision or your money back' or 'package deals.' There are never any guarantees in medicine… Be cautious about 'slick' advertising and/or deals that sound 'too good to be true.' Remember, they usually are. There is a lot of competition resulting in a great deal of advertising and bidding for your business. Do your homework." FDA warns about deceptive LASIK ads

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Report false or deceptive LASIK advertising

The Federal Trade Commission (FTC) regulates LASIK advertising. Some LASIK ads are misleading; others are outright deceptive. LASIK ads never disclose contraindications, risks, or warnings. If you feel a LASIK ad is false or misleading, you may report it to the FTC at the following link: File a Complaint

Read the FTC Guidance for Marketing of LASIK

When Medicine and Marketing Meet

Michael W. Malley, LASIK Marketing Consultant: "Discussing long-term post-LASIK visual needs with a patient is probably not a good idea BEFORE they have the procedure." Ophthalmology Management, February 2007

Kay Coulson, LASIK Marketing Consultant: "Recommend what the patient should do. If a refractive counselor cannot commit to a patient that they are a candidate without having the surgeon review the chart, you have not set LASIK criteria appropriately for your staff. If you present patients with a full-distance vision vs. monovision LASIK option and send them home to think about it, you have lost the patient. The same for advanced surface ablation vs. phakic. Reason through the options silently while examining the patient and reviewing test results, but make sure that patient is very clear about what you recommend and aim to schedule the surgery at the time of consultation". Ophthalmology Management, November 2007

Marguerite McDonald, MD: "Sometimes, listeners then ask me if they should wait for the next procedure. My favorite response involves an analogy to a car. I explain that they are hardly likely to wait 10 years to buy an automobile, because the currently available models function beautifully." Cataract & Refractive Surgery Today, May 2007

These comments sound like used car salesmen. Maybe Dr. McDonald doesn't understand that you can't "trade-in" your LASIK damaged eyes for a new pair in a couple of years.

Refractive surgery advertising raising red flags in Washington

EyeWorld, August 2001
From the article:

"With competition heating up in refractive surgery, more physicians and surgery centers are promoting themselves through advertising and marketing techniques that probably would have been anathema to the profession just a few years ago.

Physicians and other professionals have the legal right to advertise under U.S. law, but when they do, their advertising is just as subject to federal consumer protections as any other advertiser. What you don't know about the laws designed to protect consumers could hurt you if your ads are questioned.

Federal laws prohibit unfair or deceptive acts or practices in advertising, and false advertising of food, drugs, and services. The responsibility for enforcement of these laws as they apply to drugs and medical devices is shared by the Federal Trade Commission and the Food and Drug Administration.

According to FTC official Matthew Daynard, advertising is considered "deceptive" if it is likely to mislead "reasonable" consumers and if it is likely to affect consumers' conduct or decisions. A practice is "unfair" if it causes or is likely to cause injury to consumers that they could not reasonably avoid and that is not outweighed by the benefits.

Daynard and A. Ralph Rosenthal, MD, director of the Ophthalmic Devices Division at the FDA, shared information about potential problems in refractive surgery advertising during a briefing at the American Academy of Ophthalmology meeting in Dallas in October."

Link to article

Ten Things Your Eye Doctor Won't Tell You Consumer Action-From SmartMoney.com

By Michele Marchetti
October 16, 2001

1. "I use my eye chart as a crutch."

Managed care continues to put a dent in all doctors' profits, but eye doctors have become especially vulnerable. Falling reimbursements have flattened once-hefty profits on procedures such as cataract surgery, and HMO hassles make it tempting for many patients to blow off that annual eye exam.

As a result, many optometrists (who provide primary eye care) and ophthalmologists (M.D.s who can perform surgery) are adapting shrewder business tactics to keep costs down and patient traffic brisk. For instance: Walk into any eye doctor's office and you're likely to see the trademark pyramid of letters that's at the heart of every eye exam. But some doctors use the eye chart as the main or worse, only component of an eye exam. Jeffrey Anshel, an optometrist in Encinitas, Calif., and author of "Smart Medicine for Your Eyes," says that when he gives eye-health presentations, "I hold up an eye chart and ask how many people think this is an eye exam. Everyone raises their hand. But vision is more than reading the 20/20 line. It shouldn't be confused with healthy eyes." A full checkup should include a glaucoma test, a check for near vision (in which you look at a target within reading distance) and dilation of the pupil, so that the doctor can look at the back of the eye to detect cataracts or age-related diseases.

2. "Glasses are my cash cow..."

Earlier this year, Glenn Ferguson visited the eye doctor for the first time in five years. The 33-year-old engineer from Buffalo, N.Y., says he was prepared to buy new glasses but not for the $200-plus price tag he was given at his doctor's office. Ferguson considered going elsewhere for the glasses but didn't want to pay for another exam.

Since optometrists and ophthalmologists rarely hand over eyeglass prescriptions without prompting, most people don't know that federal regulation requires eye doctors to release them so that patients can comparison-shop for glasses. And why would they? In order to offset the high overhead of managing a practice, doctors and optical retailers may jack up the prices of glasses they sell from 50% to 80%, estimates Harold Koller, an ophthalmologist in Meadowbrook, Pa. "Some of my friends say the annual profit of having a dispenser in their office is between $25,000 and $50,000." After learning he was entitled to his prescription, Ferguson took it to Wal-Mart, where he found a pair of glasses similar to those at his doctor's office, but for $100 less.

3. "...and contact-lens discounters are my enemy."

Contact lenses are another area where you can save a lot of money, given the chance. Mail-order distributors, discount chains and online retailers offer discounts of about 20%. And while some doctors will hand over the prescription if you ask, many don't have to: There is no federal law requiring doctors to release contact-lens prescriptions.

In this case, the concern isn't completely about profits. Contact lenses can be more problematic poorly fitting or irritating for patients than glasses; once a doctor hands over that paper, he loses not only a potential sale, but also control, says Peter Ferguson, a spokesman for the New York State Board for Optometry. "What if something goes wrong? Could this somehow be turned around [to blame the doctor] if the contacts are defective?"

Even though 27 states (including Texas and New York) have their own prescription-release laws, doctors can still make the process difficult for lens wearers. A recent survey by the Consumers Union Southwest Regional Office revealed that more than 50% of Texas optometrists were requiring follow-up visits before they would hand over the prescription.

But there's some good news for patients. Major contact lens manufacturers including Bausch & Lomb, CIBA Vision and Johnson & Johnson along with the American Optometric Association, are agreeing to settlements in federal court on allegations of conspiring to strong-arm consumers into buying contact lenses from eye doctors. The lawsuit alleged that the manufacturers and the optometric association tried to limit contact lens sales to eye doctors or retail outlets and that the association encouraged optometrists to withhold prescriptions from their patients. If you bought lenses after 1998, you may be eligible for a rebate; check out www.freecontactlensrebates.com.

4. "Your kid may not even need glasses."

in school yards across the country, "four eyes" is no longer an insult. Glasses are hot, and eye doctors are ready to cash in on the trend. According to Koller, outgoing chairman of the American Academy of Pediatrics' section on ophthalmology, children are more likely than adults to want glasses they don't need because "the people they idolize often wear glasses." (Blame that Potter kid.) But kids' glasses can run upwards of $300.

How can you tell whether your kids really need glasses? The most common eye problem in children under five is excess farsightedness (indicated by headaches, eye fatigue and crossed eyes); after five, Koller says, nearsightedness is more likely, evidenced by sitting close to the TV or squinting to see things far away. If your child is showing symptoms, see your pediatrician first, Koller advises. Those headaches could be the result of sinus problems, a learning disability or even migraines, a common cause of blurred vision in school-age children. "Glasses don't cure everything," says Koller.

5. "I blur the truth about laser surgery."

Lasik the procedure that uses a laser to correct vision by reshaping the cornea is all the rage with patients and ophthalmologists alike, and it's easy to see why. In the 15 minutes it takes your doctor to zap a laser in both of your eyes, he earns enough to buy a ticket to Honolulu. According to John Pinto, president of an ophthalmic management-consulting firm in San Diego, the typical Lasik practice earns a 30% margin on a procedure that costs the consumer, on average, $1,200 per eye. Furthermore, he says, in any given market of 1 million people, there will typically be about five doctors dividing up an annual $8 million pie.

Not surprisingly, doctors will do whatever it takes to lure patients, from radio ads to free informational cocktail parties. But patients should be wary of those marketing messages. "It's hard to separate fact from fiction," says Kerry Solomon, associate professor at the Storm Eye Institute at the Medical University of South Carolina. One company even sells doctors personalized Lasik education books for consumers that describe them "as the surgeon who wrote the book on Lasik." Another dubious claim: William Trattler, an eye doctor in Miami, received a letter from a local Lasik surgeon trying to turn fellow physicians into customers. In the letter the doctor claims that his center has "the most statistically significant excellent results in the U.S." Trattler disagrees. "How can he compare his results to every doctor in the country when less than 1% of all surgeons even publish their results?"

6. "I learned Lasik in four days."

Is four days enough time to learn how to operate on a patient's eyes? At least one Lasik course director thinks so. The following advertisement was found on EyeWorld.org, an online publication for ophthalmologists: "SUMMER SPECIAL!! Obtain Lasik skills in a four-day, complete training course and avoid the awful 'learning curve.'" Gabriel Child, director of the course in question, The Real Lasik Course, defends his program by saying that he has found no significant difference in complications between the procedures performed by newbies and those done by the teaching ophthalmologists.

But if a Cliff Notes version of surgical training doesn't sit well with you, ask your surgeon how many procedures he or she has performed. Trattler who learned Lasik at a yearlong cornea fellowship at the University of Texas Southwestern Medical Center says a high number doesn't necessarily mean a better surgeon, but the average surgeon will surmount the learning curve after about 100 cases.

7. "Surgery's wrong for you? Don't expect me to stop you."

To Erik Petersen, a 25-year-old artist from Prescott, Ariz., laser surgery seemed like the perfect solution: He had never liked glasses, and his persistent dry eyes made it hard to wear contacts. Surgery, however, did little to fix his vision. As the doctor worked on his left eye, Petersen felt a sharp pain "that freaked me out" so much that the doctor couldn't operate on the other eye. It was a blessing in disguise. With his left eye, he now sees massive halos over objects, and every morning it "feels like it's glued shut." And since his vision in each eye is now so different, contacts are his only option.

Before surgery, Petersen says, the doctor's staff told him that his pupils were abnormally large and, as a result, he might experience halos and other side effects. "But they made it seem like it wasn't a big deal." He also says he was called a "perfect candidate for the surgery." Petersen's Phoenix-based doctor denies calling him a perfect candidate, adding that "we caution and spend time with people who have larger pupils." (Petersen signed a consent form acknowledging that because of large pupil size he might be at a higher risk for complications.) Trattler says that people who want Lasik because they can't wear contacts may indeed have a dry-eye problem after the surgery. Other patients who should think twice about Lasik: anyone who's had a herpes infection, a lazy eye, or severe myopia or astigmatism.

8. "Sterile equipment? Nope. But hey, we washed it."

Peter Brett, a 42-year-old oncologist in California, was horrified last year when he read an article from the San Francisco Chronicle about the eye center where he and his wife had both had laser surgery; supposedly, instead of sterilizing the surgical microkeratome blades, the clinic rinsed and reused them. Brett was so concerned that he and his wife were tested for Hepatitis B and C, as well as HIV. (All tests were negative.) In a settlement to an investigation brought by the Medical Board of California, the doctors in question admitted that the protocol was to rinse and reuse a blade on up to four eyes; the board concluded that the doctors departed from the standard of care and placed them on probation.

If not for a former employee, the Lasik center's practice probably would have gone undetected; after all, it's technically legal for doctors to perform Lasik in a nonsurgical facility. According to Glenn Hagele, founder and executive director of the Council for Refractive Surgery Quality Assurance, "all you need is a reasonably clean room." In other words, it doesn't have to be sterile. "Many doctors don't even wear gloves when they do this procedure." Though Hagele believes that risk of infection is minuscule, that's little comfort to Brett, who was "disgusted" that the doctor wasn't sterilizing blades between patients: "As a physician, you know that's how diseases get transmitted."

9. "Open your eyes and I'll be gone."

Ever heard of "co-management"? It's a controversial trend in eye care in which an eye surgeon can share postoperative checkups with an optometrist who, in turn, gets a cut of the surgery fee. This arrangement sometimes makes sense for patients, especially those who live in rural areas and have had surgery far from home.

But it can also be disastrous, since the risk of complications bleeding, infection or retinal detachment are much greater in the first 10 days after surgery, says Alan Mendelsohn, president of Florida's Broward County Medical Association. "There's no other specialty in medicine," he says, "where a surgeon doesn't see his patients postoperatively."

Such agreements are causing outrage in Florida, where it was found that some optometrists, unable to handle severe complications, dumped their patients off at emergency rooms. "Some optometrists in Pensacola were shipping patients to [an ophthalmologist in] Tallahassee for surgery because they were getting $700 per eye in kickbacks," says Mendelsohn. "But if three days later the patient said, 'My eye hurts like hell,' they didn't want to drive 250 miles back to Tallahassee." If you're referred to an out-of-town surgeon by your local eye doctor, ask for the qualifications of the surgeon, the terms of your postoperative care and whether your optometrist has any financial incentive in the referral.

10. "You're a guinea pig."

Eye care is one of the most rapidly advancing areas of science, and the benefits to patients can be life-changing. In fact, it's quite easy to find an eye doctor conducting a clinical trial of some new, experimental treatment. Devices that aren't approved by the FDA for any use, however, require informed consent from all patients. Unfortunately, when it comes to fully understanding the risks, patients are often in the dark.

Richard Galex, an attorney in East Brunswick, N.J., agrees. In the past 20 years, Galex has represented nearly 100 patients who were implanted with an artificial lens to treat cataracts. Many of the lenses didn't fit properly and rubbed against the cornea, resulting in some patients needing corneal transplants; others just lost their vision. According to Galex, many of his clients weren't aware that the lenses weren't FDA-approved. The consent forms "never used the word 'experimental,'" he says. "Everyone said, 'had I known it was experimental, I never would have participated.'"

How can you protect yourself? Linda Puetz, an education specialist at the Kansas City, Mo.-based Midwest Bioethics Center, advises patients to ask whether the doctor has any financial incentive (many own stock in the companies that manufacture the devices). And don't assume your doctor understands all the risks. Check out www.medwebplus.com and www.centerwatch.com, which offer detailed information on ophthalmologic clinical-research studies. Link to Article

Patient Information Booklet

Did you receive the FDA Patient Information Booklet? The FDA requires surgeons to provide prospective LASIK patients with a Patient Information Booklet. The booklet provides data from the clinical trials, including potential risks, complications, side effects, and contraindications. However, very few patients are given a booklet by their surgeon. Click the booklet to read more.

booklet

The FDA website provides a link to the Patient Information Booklet, also known as "labeling", for all FDA approved laser for LASIK.

FDA approved lasers for LASIK