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FTC: PCM president must recant former orthokeratology assertions
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MEMPHIS, Tenn. - Since founding the Mid-South PCM Group roughly 5 years ago, J. Mason Hurt, OD, has taken a considerable amount of heat from those in the optometric community critical of the method of orthokeratology (ortho-K) - precise corneal molding (PCM) - he claims to have developed (see Primary Care Optometry News, "Controversy surrounds precise corneal molding," March 1996, page 42).
With several colleagues accusing the entrepreneur-optometrist of deception and misrepresentation regarding the long-term benefits of this method, and the Federal Trade Commission (FTC) demanding a complete retraction of any "false or misleading" advertising or marketing information disseminated by the Tennessee-based company, Dr. Hurt and PCM are under intense scrutiny once again.
The commission alleges that Dr. Hurt and others associated with the Mid-South PCM Group, Eye and Vision Clinic and the International Computerized Orthokeratology Society Inc. (ICOKS) used false or misleading claims to market and sell the service of PCM ortho-K.
Despite numerous attempts by Primary Care Optometry News to reach Dr. Hurt, he had not responded by press time.
Differing results, opinions
In the previous interview with Primary Care Optometry News, Dr. Hurt said that PCM is based on ortho-K principles, in that rigid lens wearing can modify the cornea's shape. But PCM uses corneal topography to precisely guide the shaping of the cornea, increasing the degree of myopia that can be corrected, said Dr. Hurt.
Proponents of the method cite excellent results and say it safely corrects even high levels of myopia beyond what traditional ortho-K has heretofore achieved. Conversely, its opponents argue PCM presents as-yet unanswered questions of safety and efficacy.
The clinician and the FTC entered into a consent agreement, published in the Federal Register Aug. 28. The terms of the agreement require Dr. Hurt and those associated with Mid-South PCM Group and ICOKS to retract any statement or assertion regarding PCM ortho-K that is not absolutely verifiable.
The ordered consent agreement prohibits Dr. Hurt from claiming that, among other assertions, ortho-K can achieve permanent vision correction.
Howard Shapiro, an FTC press officer, confirmed that the order contains prohibitions against alleged claims by Dr. Hurt.
"A consent agreement is where the bottom line is to get them to stop doing what they're doing - before they do it again," Mr. Shapiro said. "If claims are made in advertising, they have to be able to back them up and have substantiation for them. If they say it, it must be true. And without admitting a law violation, the doctor has agreed to be bound by the terms of this order."
In the order, the commission's complaint charges that, "the proposed respondents (J. Mason Hurt, OD, et al.) engaged in deceptive advertising in violation of [several sections of] the FTC Act by making false and unsubstantiated claims that: PCM ortho-K provides a cure for any refractive vision deficiency thereby permanently eliminating the need for all corrective eye wear, including eyeglasses and contact lenses, and all people can achieve normal vision without eyeglasses or contact lenses on a permanent basis if they wear PCM ortho-K devices occasionally or at night."
The FTC also alleges in the published complaint that Dr. Hurt and those associated with his company and ICOKS made claims that PCM ortho-K has been approved by the Federal Aviation Administration and all branches of the U.S. military for use in correcting refractive vision deficiencies.
The complaint continues in alleging that the company used four named university studies to "prove that PCM ortho-K is safe and effective in correcting nearsightedness, farsightedness and astigmatism," as well as marketed testimonials by consumers for Dr. Hurt and his company in which it was implied that "PCM ortho-K patients typically achieve 20/20 vision and no longer need corrective eye wear."
Scientific evidence key
"The complaint alleges that his claims for the procedure were unsubstantiated," Mr. Shapiro explained. "And under the settlement he cannot make the claims as they were alleged in the complaint or for any other substantially similar services. He must possess and rely upon reliable scientific evidence for claims about the number of people who can achieve normal vision without eyeglasses or contact lenses on a permanent basis."
The order also prohibits Dr. Hurt from advertising or implying that his treatment is endorsed by any governmental or professional entity unless it is true, Mr. Shapiro said. Nor, under the order, can the clinician use any testimonial of a typical experience unless it is either true and substantiated or is accompanied by a disclosure describing what results program participants could expect or states that a consumer should not expect similar results.
Additionally, the order prohibits Dr. Hurt from misrepresenting study results or sending any material containing claims prohibited under the settlement to an eye care provider. The PCM president is required, according to FTC sources, to send notice to each optometrist with whom he has done business requesting that any of his materials that violate the settlement not be used and to terminate any optometrist's right to market or perform PCM ortho-K if any ad or promotion restricted by the settlement is disseminated.
"Each violation of an order can result in [a fine of] up to $11,000 for each single violation," Mr. Shapiro said.
For Your Information:
- Howard Shapiro is a Federal Trade Commission press officer. He can be reached at the FTC, 6th & Pennsylvania Ave. NW, Room #421, Washington, DC 20580; (202) 326-2180; fax: (202) 326-3676.