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 Post subject: Advertising can be downfall in RS, Jan 2002
PostPosted: Tue Feb 12, 2008 3:16 am 
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OCULAR SURGERY NEWS U.S. EDITION January 1, 2002

Advertising can be downfall in refractive surgery, even without outrageous claims

The FTC is actively looking into claims made by refractive surgeons that go beyond what can be expected by patients.

NEW ORLEANS ? Government regulatory agencies are warning the refractive eye care market that surgeons and surgery centers need to rein in their advertising policies. During a symposium here at the American Academy of Ophthalmology meeting, Walter Stark, MD, chaired a session that featured presentations from the Food and Drug Administration, the Federal Trade Commission and an Academy representative.
During the sparsely attended symposium, the presenters warned surgeons and surgery centers that refractive surgery lawsuits are on the rise and that the ways surgeons and companies advertise their services can play a large role in the outcomes of these cases.
FDA director of ophthalmic devices, A. Ralph Rosenthal, MD, warned that any claims made in advertising or promotional material produced by surgeons or surgery centers must be included in the refractive surgery device?s labeling.
?A doctor may use a device off-label; however, if it?s not stated in the labeling, a company or doctor cannot promote it,? he said. He also pointed out that laser epithelial keratomileusis (LASEK) is currently an off-label use of an excimer laser.
A procedure can, however, be promoted off-label if the advertising is being used to obtain subjects for a clinical trial. Dr. Rosenthal also warned that in any advertising the surgeon or center must disclose any complication, contraindications or other relevant labeling.
?Draft your claims carefully?
Perhaps the strongest warnings came from the FTC. Matthew Daynard from the FTC?s Division of Advertising Practices warned that the FTC is actively looking into improper and inaccurate advertising that is brought to the agency?s attention or found in their own investigations.
Mr. Daynard said the FTC?s first mode of attack is prevention. He noted that the FTC and the AAO collaborated several years ago to draft advertising guidelines for refractive surgery. However, in his estimation more and more surgeons and surgery centers have chosen to ignore these advertising policies that were created for their and their patient?s protection.
If a surgeon or surgery center chooses to ignore the FTC?s guidelines and his FTC division finds out about it, Mr. Daynard said the doctors could expect an advisory letter, indicating that their advertising may be false or misleading. The letter will suggest that they should change their advertising and the letter will tell doctors that if they have questions on how to change their advertising, they should contact the FTC.
However, when the FTC runs across grossly exaggerated efficacy claims or business practices, Mr. Maynard warned that those could require law enforcement actions that could result in public ?consent? orders.
He advised doctors that their best bet was to work with the FTC, the AAO and local medical boards to develop accurate and effective advertising and to follow the established guidelines closely.
Be forthright
?Tell the truth, tell all the truth and make sure it is the truth,? Mr. Daynard said. ?Anecdotal evidence is never adequate for advertising. The use of customer testimonials can be deceptive if the underlying efficacy claim is not substantiated. And physician endorsements must disclose any personal or financial connection to the marketer that consumers would consider important.?
Some claims are questionable on their face, he explained. These include such claims as, ?Throw away your glasses,? or ?eliminate the need for eyewear.? He said this claim in particular is troubling because it is an unqualified claim that is likely false, because many complications associated with night driving have not been eliminated and presbyopia will eventually affect most men and women.
Mr. Daynard also spoke about a recent article in The Washington Post that discussed up-selling or ?car salesman? tactics.
?Up-selling is a questionable practice. If you advertise ?20/20 for $499 per eye? and most of your 20/20 results are paying $759 per eye, that is a cause for concern by the FTC. Fine print disclaimers may not fix the problem. Patient counselors paid on commission to stimulate higher prices may be a questionable practice in this context,? Mr. Daynard said.
He also pointed out that ?lifetime commitment? claims could be a dangerous promise.
?Things seem to be taking a downturn. It seems like more ads are appearing that make spurious claims. You can?t have a disclosure that contradicts a headline. If the majority of patients are not receiving the low-price and vision claim, it may be a violation of state laws. If you have a question, send your ads to your state attorney general, state MD/ophthalmology board or the FTC,? he said.
And in protecting U.S. interests, Mr. Daynard promised that when deceptive claims are made by Canadian or Mexican refractive centers that advertise in the United States, the FTC will ask their Canadian or Mexican counterparts to intervene.
Lawyers learning refractive litigation
Richard L. Abbott, MD, told the physicians and industry people in the audience that advertising is a fickle form, especially when it is involved in lawsuits. He said that trial lawyers are now learning how to litigate refractive surgery suits for patients.
?Safe and effective claims are the most fruitful form of attack for litigators. Malpractice rates are going up, as are settlements and awards,? he said.
He noted that there have been 83 lawsuits filed from 1997 to 2001. Even more were still in the litigation pipeline, with more being filed every day.
California has had the most refractive surgery trials with 30, followed by Colorado with seven and Florida with five.
To make matters worse for refractive surgeons, Dr. Abbott said the press is now pointing out misleading ads, which causes damage to the industry as a whole.
He suggested that surgeons ?should have a risk manager or lawyer look over your ads. Or just use common sense. Patient expectations are high, but are they realistic? It?s the surgeon?s job to make that determination.?

For Your Information:
? Walter J. Stark, MD, can be reached at 600 N. Wolfe St. Maumenee, Baltimore, MD 21287; (410) 955-5490; fax: (410) 955-0867.
? A. Ralph Rosenthal, MD, can be reached at Division of Ophthalmic Devices, 9200 Corporate Blvd., Room 250C, Rockville, MD 20850; (301) 827-4601; fax: (301) 827-4601.
? Matthew Daynard can be reached at Federal Trade Commission, CRC-240, Washington, DC 20580; (202) 326-3291; fax: (202) 326-3259; e-mail: mdaynard@ftc.gov.
? Richard L. Abbott, MD, can be reached at UCSF Beckman Vision Center, 10 Kirkham St., K-301, San Francisco, CA 94143; (415) 502-6265; fax: (415) 502-7418; e-mail: rabbott@itsa.ucsf.edu.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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