1. 0 Case Study 1 Advertising

2. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Disclosure  The speaker has no financial interest in the subject matter of this presentation and is not representing the Ethics Committee of the American Academy of Ophthalmology with this presentation.  For questions about the material contained herein or about the Academy’s ethics program in general, please contact the ethics program manager, Mara Pearse Burke at ethics@aao.org.ethics@aao.org

3. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 3 Advertising The Ethical Perspective  Never mislead, by commission or omission  Never misinform  Never trick or deceive On medical details On economic details  Never exaggerate qualifications

4. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 4 Code of Ethics Rule 13 Communications to the public  No false, deceptive or misleading information  No deceptive omissions  No appeals to patients ’ anxiety  Must not create unjustified expectations of results  Must disclose risks  Must not misrepresent credentials  No unsubstantiated claims of superiority

5. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Superior to all other Tri-State Area practices?  Unrealistic patient expectations ?  40,000 LASIK procedures by center ’ s partners but only about 100 by the new surgeon. 

6. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 6 “ The Leading Eye Care Provider ”  Implication that the Golden EyeCare practice is superior (the “leader”) to all the other ophthalmology practices in the Tri-State area.  Unable to substantiate without access to all business and surgical databases of each practice in that entire area.

7. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 7 “ Performed Over 40,000 LASIK Procedures ”  An express claim intended to imply a level of experience for the surgeons in the group.  Misleading if as a group they have performed 40,000 LASIK procedures, but one relatively new surgeon has performed a low number.  May disadvantage the competitor down the street who is in solo practice, but has experience and volume.

8. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 8 “ Visual Freedom…Only takes a Few Minutes ”  Potential to created unrealistic patient expectations of permanence.  May fall into an “ express ” or “ implied ” claim per FTC guidelines.  Advertisers must have proof to back up claims consumers may reasonably take from an ad.  Implies freedom from corrective lenses for a lifetime.

9. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 9 Practical Advertising Types of Claims  Express claims - specifically states support “ Studies show ” “ Clinical research proves. ”  General claims - non specific global claims “ medically proven ”  Implied Claims - suggests something is true “ Throw away your glasses ” (or related graphic)

10. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 10 Practical Advertising Examples of Basic Content  Type of practice  Credentials Objective information (e.g. board certification)  Office hours, location  Description of services

11. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 11 Practical Advertising Substantiation  Applies to all claims, expressed or implied  Advertising claims must be substantiable Sufficient to support the claim Objective fact Competent, reliable science Not anecdotal  Substantiation must be available at time of claim

12. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 12 Practical Advertising Claims of Superiority  Must be subject to objective substantiation “ More than 1000 procedures per year ” “ Board certified ”  Puffery or exaggeration E.g. “ Best service in the galaxy ” Common in non-medical advertising May be considered unethical in medical advertising

13. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 13 Practical Advertising Claims of Superiority “ It must be stressed that Rule 13 bars not only claims of superiority which are demonstrably false, but also those which simply cannot be substantiated. ” Advisory Opinion on the Code of Ethics, 84-1

14. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 14 Enforcement and Perils FTC Remedies for Serious Cases  The FTC can order the advertiser to cease and desist from running an advertisement.  A fine of $11,000 per day per advertisement For occurrences after determination of violation  Orders for retractions, corrective advertising

15. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY 15 FDA Letter to Eye Care Professionals (May 22, 2009)  The FDA has received complaints that eye care professionals ’ advertisements for LASIK procedures and FDA-approved lasers used for the LASIK procedures failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures.  The FDA believes that eliminating deceptive or misleading health-related advertising claims is an important part of protecting the public health.  In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts … with respect to consequences which may result from the use of the device…

16. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY What Do You Think? What advertising is misleading and what is informative? What claims of superiority are truly substantiatable?