While the main purposes of Drs. Goldstein and White’s letter seem to be to promote the Academy of Laser Dentistry and to discredit the authors, they nevertheless make a few comments that I feel deserve comment.
The Academy of Laser Dentistry, in my opinion, is not the only source of scientific information about lasers in dentistry. There are a number of other laser organizations within medicine, dentistry and engineering that contribute greatly to the multidisciplinary knowledge base and that have great expertise.
Furthermore, I hope Drs. Goldstein and White do not intend to imply that other organizations dedicated to the improvement of patient care (examples: the American Dental Association, the specialty organizations, the American Association for Dental Research and the International Association for Dental Research), and that do not have a bias toward any one particular technology, do not also have expertise that is critical to assessing lasers or any other technology with respect to its safety and utility in dentistry. In my view, to make such an assumption, tacitly or otherwise, is folly.
This leads to the concern that organizations based on the promotion of a particular technology may be biased toward being overly optimistic with regard to their assessment of their technology. In this light, it may actually be that part of the real value of our article is that neither Dr. Bushick nor myself are members of the Academy of Laser Dentistry, and have no apparent bias favoring the promotion of lasers in dentistry. It was our assumption that the readership wanted a more objective view, and this is what we believe we have provided.
Drs. Goldstein and White provide a litany of examples of respected study designs, and then profess a high degree of faith in the 510(k) process of the Food and Drug Administration to determine safety and efficacy. The inconsistency here, as I see it, is that the 510(k) clearance studies are usually very limited and intend only to show approximate "equivalency of result" with existing technology already on the market, even if that means comparing disparate modalities like stainless steel curettes and high-intensity pulsed laser irradiation. (And what is even more amazing is that the definition of the application is left to the applicant, with little critical review from the FDA.)
In a practical sense, the 510(k) clearance process is intended to expedite the way to market, and to provide only a minimal assurance of equivalence. Very often, specific issues relating to safety and efficacy are not even addressed. The FDA (and the public) depends upon the profession itself to continue scientific scrutiny of devices cleared to market and their corresponding applications. In other words, we must police ourselves and not depend totally on the FDA.
To give the same credibility of a multicentered trial (such as those that are seen in FDA pharmaceutical trials) to a simple 510(k) medical device clearance is to equate NASA’s shuttlecraft with the Wright brothers’ airplane. I believe that Drs. Goldstein and White have misplaced their faith in the 510(k). Logically, however, promoting the 510(k) to be more than it is would appear to be consistent with a bias toward overly optimistic promotion of lasers.
The articles that Drs. Goldstein and White criticize us for omitting actually support laser applications already listed in the article, so their inclusion would not have changed the substance of or added anything new to the article. As we mentioned in our article, this article was not intended as a complete review of the literature, but as a representative view. Not every article supporting every point could be included. However, I do heartily encourage anyone to bring to my attention peer-reviewed and published studies that support any application not listed in the article, and I would be happy to include it in the overall analysis.
Reviews of the peer-reviewed literature are an important way for the profession to address scientific controversy. They provide a format for systematic and collegial discourse and mutual learning. It is a far superior way of managing progress than abdicating this responsibility to special-interest groups, as Drs. Goldstein and White seem to suggest we should.
