Lasik Eyes Surgery - "Safe," "harmless," "painless," "cure," "

Author

"Safe," "harmless," "painless," "cure," "

gospa68@aol.com

2005-04-11, 6:14 pm

THIS APPLIES EQUALLY TO REFRACTIVE SURGERY...Does the CRSQA montior
member ads to see that they are adhering to these criteria?
WK

Advertising Claims Containing Certain Potentially Misleading Phrases
Issues Raised:

In what circumstances is it deceptive to claim that certain ophthalmic
procedures are "safe," "harmless," or "painless;" that treatments will
"cure" patients; or that ophthalmologists are "pioneers," "leaders," or
"world famous"?

Applicable Rule:

Rule 13. Communications to the Public

Background

Like all physicians, ophthalmologists have an obligation to present
themselves and the services they offer in a manner that is neither
inaccurate nor misleading. This principle of ethical conduct is also
enforced by law.

An ophthalmologist's misrepresentation of his/her qualifications, or
the nature of an ophthalmic procedures is an ethical violation because
a successful physician-patient relationship is built on trust and
confidence and carries with it the assumption that the physician has
provided the patient with an accurate assessment of his or her problem,
an appropriate recommendation for treatment, and an honest
representation of the physician's ability to carry out that therapy.
Because patients may be relatively uninformed on issues related to
health and health care, it is imperative that practitioners avoid
misrepresentations that would deny the patient information needed for
making truly informed decisions.

First Inquiry

Facts -- Dr. A, a member of the American Academy of Ophthalmology, has
an extremely active practice that largely consists of cataract surgery
and he places an advertisement in several local papers announcing his
practice. The ads include the statements that "My
state-of-the-art laser surgical technique for cataract or
glaucoma is safe, harmless, and painless" and that "We will cure your
visual problem." A colleague is concerned that these ads may be
deceptive to patients, and has inquired whether they are consistent
with the Code of Ethics.

Resolution - To call a procedure "safe" is to make one of three
possible claims. It means (1) that the procedure is absolutely safe
(i.e., there are no risks) (2) that the procedure is comparatively safe
when compared with alternative procedures for the same problem; or (3)
that it is safer than surgery for another problem. If the first meaning
is intended, the statement clearly is false, since all surgical
procedures, including cataract surgery, carry some degree of risk, even
if the risk in a particular case is low.

If the second meaning were intended, the ad would also be deceptive
unless the procedure is demonstrably safer than alternative techniques
for cataract surgery. If this is so, the advertiser should have
credible clinical evidence to support that claim. Such a claim may be
difficult to prove, because the safety of a procedure often varies with
the circumstances, e.g., the medical status and characteristics of the
individual patient.

If the third meaning is intended, the advertiser simply means to convey
the fact that his cataract surgery is safer than surgery in general
(such as triple bypass heart surgery). Without further explanation,
this is a deceptive comparison.

Because the safety of a surgical procedure is necessarily a qualified
concept, simply using a phrase such as "safe" is likely to deceive
prospective patients. The failure to qualify the claim of safety is
particularly objectionable because a variety of phrases could easily be
used to communicate the safety/risk relationship (e.g., "relatively
safe," "safe for most patients," or "among the safer types of
surgery").

The Academy is also concerned that many potential patients may
understand the unqualified phrase "safe" to refer to some consensus and
possibly government-approved standard of adequate safety, similar to
the Food and Drug Administration's determination that a prescription
drug is "safe and effective." Because using an unqualified phrase such
as "safe" is likely to be misunderstood as implying absolute safety,
and because doing so suggests a benefit of a procedure without
discussing risks, it is likely to violate Rule 13 of the Code of
Ethics.

Similarly, the term "painless" with respect to an ophthalmic surgical
procedure is seldom accurate and is usually deceptive. To say that an
operation is painless is misleading if the statement refers to only
part of the entire surgical treatment. The discomfort that occurs at
the time of surgery can be minimized or in many cases eliminated by the
use of local or general anesthetics. However, since anesthetics may
involve an injection or installation of an irritating topical agent,
the statement is not literally true. Second, it is not uncommon for
patients to feel some discomfort in the postoperative period. Third,
possible complications such as glaucoma, infections, or inflammation of
tissue can cause pain such that a painless course of treatment cannot
be assured. To a patient, the statement that a surgical procedure is
painless almost surely means that the entire experience -- preparation,
surgery, and recovery -- is painless. Such a statement is almost always
misleading.

The reference to using the laser maybe a deception to attract patients
who fear conventional surgery, which they associate with pain. This
distinction is usually deceptive, except in the rare event that laser
emulsification (currently investigational) is used as part of the
surgical removal of the lens.

Likewise, use of the term "cure" with reference to ophthalmic problems
is often deceptive. To cure a condition means that as a consequence of
treatment, the condition no longer exists and will not recur for any
reason. For example, to perform a trabeculectomy or laser
trabeculoplasty on a patient with primary open-angle glaucoma cannot be
said to cure the glaucoma. First, the visual incapacitation caused by
any pre-existing glaucomatous nerve damage will continue. Second, the
surgical procedure may not lower the pressure adequately to obviate the
need for supplemental medication. Third, intraocular pressure may not
be lowered adequately even with the use of medications postoperatively,
and visual field loss may continue. In addition, glaucoma procedures
may undergo late failure even after years of functioning well. All of
these situations mean that the patient continues to need testing,
examination, and ongoing care, even if the intraocular pressure is
lowered to the point where further visual field loss is halted. In
other words, the patient continues to have primary open-angle glaucoma
for the rest of his/her life. In the case of cataract surgery, the lens
implant is an exogenous prosthetic device that approximates, but does
not replace, the function of the human lens.

Thus, in order not to be misleading, the term "cure" should almost
always be further explained and qualified to give the patient an
accurate understanding of his/her prospects for improvement.

The Academy is not prepared to say that all ads that contain the words
"safe," "painless," or "cure" are deceptive. In this case, the ad using
these terms appears to be inconsistent with Rule 13: the terms were
used without other qualifications or explanations and applied to
surgical procedures with risks of pain, complications, and incomplete
success. The degree to which the claims may be true varies greatly and
no substantiation is provided.

Second Inquiry

Facts - Dr. B is a well-respected cataract surgeon with an expanding
practice in a small city in a "sunbelt" state. On several occasions he
has offered his services to a charitable organization, that has
sponsored him and other eye professionals to travel to less developed
countries to perform eye surgery for one week per year. Dr. B has not
published any papers in refereed journals, but he has lectured at
continuing medical education seminars on three occasions. Generally, he
lectures on the success he has had in using a particular brand of
intraocular lens and on his low rate of postoperative complications.
Although his practice is largely local, he does operate from time to
time on visitors from abroad, particularly from Latin America. In order
to market his practice, Dr. B places advertisements in local newspapers
each Sunday. The ads state in relevant part, "If you need cataract
surgery, don't you want a top surgeon? Call Dr. B, a surgeon who is
famous around the United States and in many other countries. Dr. B has
pioneered certain advances in cataract surgery and participated in
developments in the field. He has lectured on his accomplishments to
medical groups across the country. You'll be in experienced hands."

Another ophthalmologist in the same city as Dr. B has inquired whether
this advertisement contravenes the Academy's Code of Ethics.

Resolution - This advertisement appears to be misleading in several
respects. First, only a very small fraction of all physicians can
justifiably claim to be "world famous" by the consensus meaning of the
term. These may include some physicians who have authored widely used
texts or who have made significant, independently validated
contributions to the care of patients. As such, it is the very
elusiveness of measures of fame that makes invoking them misleading
trying to lure patients. Merely traveling extensively, presenting
addresses at professional meetings, or treating patients from abroad
does not mean that a physician is world famous. To so indicate is to
exploit the inherent imprecision of the concept of fame to mislead
patients. There can be little question that such claims are employed in
order to give patients the impression that the surgeon meets some
objective, high level of competence, skill, or recognition -- which may
not exist with respect to the advertiser. The same is true of Dr. B's
advertising himself as a "top surgeon." To be literally true, "top"
must refer to an objective and verifiable criterion in which the
surgeon actually exceeds all others.

Saying that one has "pioneered certain advances in cataract surgery" is
also deceptive in this case. Such a phrase clearly connotes a
significant, independently validated breakthrough, not a minor
alteration or refinement of conventional procedures. Simply being one
of many investigators for one type of intraocular lens, using one piece
of equipment, or using a slightly modified surgical procedure does not
justify use of a hyperbolic term such as "pioneered." Since all surgery
requires some degree of innovation, a surgeon cannot meaningfully claim
to be an originator or developer of a technique or product simply
because he or she has modified in some minor way what existed before.

Use of the phrase "participated in developments in the field" suffers
from a related but different flaw. Read literally, it means virtually
nothing because "developments" and "field" are undefined. Its use to
suggest an accomplishment is therefore illusory by performing surgery
and maintaining patient records, every surgeon "participates in
development" in the sense of seeing outcomes upon which alterations or
advances in surgical techniques are based. This is roughly the same as
the vague assertion that every human being participates in the historic
evolution of mankind. To advertise using such phrases thus appears to
be misleading unless the ophthalmologist has personally contributed
significant advances that have been adopted by colleagues this does not
appear to be true of Dr. B. Thus, Dr. B appears to have acted
unethically by engaging in advertising that is designed and intended to
deceive patients.

In summary, use of the terms "safe," "harmless," "painless," "cure,"
"pioneer," "leader," "world famous," and similar such words should be
used with caution, and only refer to truthful and verifiable qualities
of the ophthalmologist and his or her treatments.

Applicable Rules

"Rule 13. Communications to the Public. Communications to the public
must be accurate. They must not convey false, untrue, deceptive, or
misleading information through statements, testimonials, photographs,
graphics, or other means. They must not omit material information
without which the communications would be deceptive. Communications
must not appeal to an individual's anxiety in an excessive or unfair
way; and they must not create unjustified expectations of results. If
communications refer to benefits or other attributes of ophthalmic
procedures that involve significant risks, realistic assessments of
their safety and efficacy must also be included, as well as the
availability of alternatives and, where necessary to avoid deception,
descriptions and/or assessments of the benefits or other attributes of
those alternatives. Communications must not misrepresent an
ophthalmologist's credentials, training, experience or ability, and
must not contain material claims of superiority that cannot be
substantiated. If a communication results from payment by an
ophthalmologist, this must be disclosed unless the nature, format, or
medium makes it apparent."

Other References

"Rule 2. Informed Consent. The performance of medical or surgical
procedures shall be preceded by appropriate informed consent."

"Rule 9. Medical and Surgical Procedures. An ophthalmologist must not
misrepresent the service that is performed or the charges made for that
service."

American Academy of Ophthalmology Advisory Opinion of the Code of
Ethics; Communications to the Public.

The Ethical Ophthalmologist: A Primer. In: Advertising. San Francisco:
American Academy of Ophthalmology; 1999 121-37.

Approved by: Board of Directors, September 1985
Revised and Approved by: Board of Directors, June 1992
Revised and Approved by: Board of Trustees, February 1997
Revised and Approved by: Board of Trustees, November 2003