admin March 7th, 2007
STATEMENT OF PURPOSE
These guidelines are designed to assist ophthalmologists in providing
truthful, informative advertising of refractive surgery. In addition to
their ethical obligations, ophthalmologists must be mindful of the
legal obligations they have in connection with the promotion of their
services.
These guidelines are not intended to address every possible
advertising claim that could be made in support of refractive
surgery. The guidelines address specific types of claims that
could confuse consumers, and/or have been subject to FTC
review. Examples of permissible claims, as well as claims
that might be considered to confuse or mislead consumers, are provided.
LEGAL FRAMEWORK
The Federal Trade Commission Act, as well as similar state laws,
prohibits false and deceptive advertising. Advertising that is
literally true, but which conveys a misleading impression to reasonable
consumers, may be unlawful. Claims made implicitly in
advertising, as well as explicit claims, can give rise to deception.
Deception can also occur through the omission of information if the
absence of the information causes the advertisement to convey an
inaccurate impression about a material fact. Thus, ophthalmologists
should insure that statements made directly or by implication in
informational, promotional and advertising materials are accurate and
do not deceive consumers.
One issue of current interest concerns the advertising of "off-label"
surgical applications using an FDA-approved device (e.g. LASIK). The
decision to use the excimer laser outside the scope of the approved
labeling is considered, by the FDA, to be a
"practice-of-medicine" issue; that is, the FDA has recognized that
"Good medical practice and patient interests require that physicians
use commercially available drugs, devices, biologics according to their
best knowledge and judgment." Physicians should be aware, however, that
advertising of off-label use, while not specifically prohibited, is
also not protected under the "practice-of-medicine."
Definition of Advertising: In addition to print, radio and television
ads, other material such as patient informational brochures, seminars,
and videos may be considered advertising for purposes of these laws.
Privileged discussions between physicians and their patients are
generally not regulated by the FTC, but may have other legal or ethical
implications. Although seminars and brochures may be considered
advertising by the FTC, physicians do have a responsibility to
adequately inform patients about alternative therapies.
Accountability: Physicians and other advertisers are legally
responsible for the truth and accuracy of their advertising, even if it
is prepared by an ad agency or other third party.
Substantiation: Medical advertisers, particularly with respect to
surgical procedures, are held to a higher standard than those who
advertise consumer products. The FTC requires that advertisers have a
"reasonable basis" for advertising claims at the time they are made.
With respect to health and safety claims for surgical procedures such
as RK and PRK, this will usually require "competent and reliable"
scientific evidence which may include, depending on the claim, the
physician's own outcomes alone or in combination with other clinical
studies. Such clinical evidence is generally considered to be stronger
if the study has been peer-reviewed and/or replicated in other studies.
The advertiser must have adequate substantiation for a claim at the
time the claim is made.
Informed Consent: Advertising need not, and as a practical matter
cannot, incorporate all of the elements of appropriate informed consent
disclosures. FTC staff has stated that certain advertising claims may
require disclosure of material information appearing in informed
consent forms (see below, Example 1, SAFETY CLAIMS). Also, advertising
may not contradict disclosures of risk made in informed consent forms
and informed consent forms will not compensate, legally or ethically,
for misleading statements made in advertising.
Testimonials: A patient endorsement or testimonial will be construed by
the FTC as a representation that the particular patient's experience is
typical or representative of the experiences generally achieved by the
physician's patients, unless there is a clear and conspicuous
disclosure to the contrary. In addition, physicians should be aware
that some states prohibit the use of patient testimonials by physicians.
ADVERTISING CLAIMS
Prospective refractive surgery patients have differing needs and
expectations and may experience differing surgical outcomes.
Accordingly, advertising claims are not a substitute for discussions
between the ophthalmic surgeon and a prospective surgery patient
regarding the patient's own needs and expectations and the range of
possible outcomes.
EFFICACY CLAIMS
Example 1: Printed at the top of a newspaper ad is the banner:
"Throw Away Your Glasses!" A reasonable consumer may infer from this ad
that he or she will be permanently free of all forms of corrective
lenses (for presbyopia and hyperopia as well as myopia) as a result of
the surgery. Even if the ad makes reference to nearsightedness, there
is a substantial risk that a significant number of consumers would
infer from the ad that if they underwent the procedure, they would
achieve 20/20 vision and would be free of glasses, including glasses
for reading or occasional use. Since the surgeon cannot guarantee that
the prospective patient would be
permanently free from all glasses, the claim is subject to legal challenge.
Example 2: A print ad headline states, "Throw Away Your
Glasses," or features a drawing of spectacles within a circle with a
line crossed through it. Other text within the ad states that
Refractive Surgery "may correct your nearsightedness and astigmatism
and may eliminate your need for glasses or contacts." Although the use
of the word "may" is intended to qualify the "no more glasses" claim,
the claim is likely to be understood by consumers, in light of the more
prominent headline or drawing, to be as unqualified as in Example 1. To
avoid confusion, the overall message of an ad should not be
inconsistent with the "fine print" qualifiers. A further modification
of the above claim, such as: "may correct your nearsightedness and
astigmatism and may allow you to function without glasses or contacts
for many activities," avoids possible ambiguities about the need for
reading glasses or glasses for occasional use.
Example 3: A radio ad includes the text: "See naturally with
refractive surgery!" The reasonable consumer would interpret "seeing
naturally,"or similar terms such as seeing clearly to mean "seeing
without glasses." Again, this kind of claim should be avoided for the
same reasons as for Examples 1 and 2, above.
Example 4: An ad picturing a smiling patient and physician
states: "If you can read the small print, but can't see well at a
distance, visit Drs. Smith and Jones to learn more about RK (or PRK)–
our typical nearsighted patient — after refractive surgery– no longer
needs glasses for many activities." Such an ad is acceptable. It
suggests that RK or PRK will treat only nearsightedness and informs
consumers about the possible need for glasses for other activities.
Example 5: An ad states: "98% of our patients see 20/40 or
better postoperatively — good enough to pass a driver's test in most
states!" Since the ad explicitly claims a result for a particular
physician group's patients, the physicians will need a study or
analysis of patient records to substantiate the claim. In addition,
this ad might be understood by some consumers to mean that since they
can pass a driver' s vision exam, they might not need to wear glasses
for other activities. This potential problem with the ad could be
eliminated by a reference to the fact that patients may still need or
desire glasses for some activities.
SAFETY CLAIMS
Example 1: An ad states: "Find out more about PRK — the safe
and easy alternative to glasses!" The terms "safe" and "safe and easy"
have attracted the concern of the FTC, as have promotional materials
that fail to disclose certain risks that may be considered to be
important by a prospective patient. Generally, it is not appropriate
for an ad to state that RK or PRK is safe and easy. Any ad that
suggests that RK or PRK is safe should include a qualifying statement
such as: "Like all surgery, RK (or PRK) surgery has some risks; we will
discuss these with you during your consultation."
In addition, it is the position of the FTC staff that advertising
containing certain claims may also need to contain relevant disclosures
in order not to be considered deceptive. An FTC staff document relating
to RK and PRK advertising expresses the following admonition:
"representations made about safety or efficacy of RK or PRK may, in
certain circumstances, require disclosures of material information
about health risks or limitations associated with the surgery to
prevent deception. For example, an advertisement containing express or
implied representations that the surgery is safe may also need to
contain information about any significant risks associated with the
surgery, and for PRK, with the particular laser in use."
Example 2: A print ad states that, "unlike other procedures, PRK
laser vision correction doesn't involve knives or cuts to the eye."
Although it is true that the Excimer laser does not use a blade to make
incisions on the surface of the eye, the statement could be misleading
to consumers by suggesting that PRK is a non-invasive procedure. It is
not appropriate to claim or suggest, expressly or through use of
euphemisms such as "treatment," "therapy," or "vision correction," or
"enhancement" that RK or PRK are anything other than invasive surgical
procedures.
While differentiation between refractive procedures may be appropriate
in order to inform consumers, it should done in a way so as not be
misleading; both RK and PRK are surgical procedures and this should be
made clear to the reader of the ad.
Example 3: An ad states: "The Food and Drug Administration Has
Determined That the Excimer Laser We Use Is Safe and Effective for PRK
Laser Surgery." Such an ad is not acceptable. The Federal Food, Drug
and Cosmetic Act forbids references to the FDA-approval status of any
medical device in advertisements.
PERMANENCE AND PREDICTABILITY CLAIMS
Example 1: An ad states: "Achieve permanent vision correction
with refractive surgery!" A reasonable consumer may assume "permanent"
to mean that their post-surgical refractive result will remain stable
throughout their lifetime. FTC staff has raised questions with issues
of the possibility of regression, drift, and possible instability
long-term, and has objected to permanency claims because of their
belief that studies of modern refractive surgery techniques available
at the time of their review did not adequately substantiate such
claims. At this time, physicians considering making claims of
permanency or predictability should be aware that this advertising will
be carefully scrutinized by the FTC. Accordingly, physicians should
avoid permanency claims unless they are able to substantiate the claims
on the basis of their own surgical outcomes alone or in combination
with current scientific evidence.
Example 2: "Visit the Smith Laser Center and leave with 20/20
vision!" This ad is problematic. A reasonable consumer could interpret
this advertisement to mean that the surgeon can guarantee,
pre-operatively, exactly what the patient's surgical outcome will be,
i.e. that refractive surgery results are predictable. To advertise
surgical predictability, physicians must be able to substantiate that
surgical outcomes are predictable in virtually all of their cases.
The use of ranges, e.g. "80 percent of our patients have 20/20 vision
following surgery," is acceptable if the surgeon can substantiate the
claim.
SUCCESS RATE CLAIMS
Example 1: "90% of RK (or PRK) patients achieve 20/40 vision or
better." If this claim is based on a clinical study, the surgeon making
the claim will need to assure that the study is scientifically reliable
and that he or she is performing the same procedure using the same
protocol as that involved in the study. If these criteria are met, the
claim would be acceptable as long as the surgeon's own outcomes did not
vary significantly from the reported results.
"PAINLESS" CLAIMS
Example 1: An ad states: "PRK surgery is a safe and painless
procedure." A reasonable consumer could understand this statement to
mean that the entire experience — preparation, surgery, and recovery
– is painless. Patients undergoing refractive surgery
typically experience some pain and discomfort for a short time
following surgery. Patients are often given prescriptions to deal with
pain or discomfort. In these circumstances, "painless" claims are
almost certain to be considered false or deceptive.
________
As with any other surgical procedure, new information and technology in
refractive surgery can be expected to evolve over time. Accordingly,
these guidelines are subject to periodic review and revision to ensure
that they reflect the latest information and
technology in refractive surgery.
These guidelines were developed and endorsed by:
American Academy of Ophthalmology
Approved, Board of Trustees, February 1997
American Society of Cataract and Refractive Surgery
Approved, Executive Committee, February 1997
International Society of Refractive Surgery
Approved, Board of Trustees, March 1997
Outpatient Ophthalmic Surgical Society
Approved, Board of Trustees, February 1997
Society for Excellence in Eyecare
Approved, Board of Trustees, February 1997