Vizilite denied ADA seal of Approval
November 10, 2005
Approximately a year and a half ago, the manufacturers of Vizilite applied to the ADA for the ADA Seal of Acceptance for their product. The official seal of acceptance is considered the ultimate in product recognition in terms of marketing a given product for use in dentistry in the United States. The Council on Scientific Affairs is charged with the review of all studies related to products requesting the seal. The companies are asked to submit all studies that support their claims. They are required to submit at least two credible clinical studies.
The usual requirement is that of two independent double blind clinical trials, each conducted at a separate site. In addition to the review of this data by the entire Council on Scientific Affairs, the studies are sent out to a number of outside reviewers. The conclusion on Vizilite was quite clear. Their submitted study data was extremely weak. All outside consultants were in agreement in not supporting the product for the seal. The Council was unanimous in not supporting the application.
As a number of you have mentioned, this technique has been employed in the study of uterine cervical epithelium. As has also been mentioned, this
epithelium is a non-keratinizing stratified squamous epithelium. I believe that all oral pathologists are in agreement that the progression of oral epithelial dysplasia to SCC is substantially different biologically from the progression of cervical epithelial dysplasia to SCC. Therefore, one cannot truly indicate that the data on the cervix is transferable to the oral cavity.
Many of you have mentioned economics. Unfortunately, I think that that is what is driving the desire to use this technique. The potential for inaccurate conclusions and greater cost to the patient appear to be the most likely outcomes to result from using the product at this point in time. In this era of evidence-based dentistry, who among us wants to support or use a technique in the absence of evidence?
Unfortunately, despite its failure to achieve the Seal of Acceptance, the manufacturers of Vizilite have increased their marketing, including a full page ad that runs in most issues of the Journal of the American Dental Association (JADA). I raised the question about whether we should be accepting ads concerning a product that we could not say was efficacious.
The bottom line given to me from the ad people is that there is no regulation of ads, JADA just needs the money from ads in order to publish (So buyer beware!).
I would hope that we educators have taught most of the practicing dentists how to examine and evaluate lesions by traditional critieria. I submit that those who do not feel confident to evaluate lesions by traditional examination parameters would probably not be adept at using Vizilite for early detection either.
The ADA informed the Vizilite manufacturers of the decision not to grant the seal and indicated that the application could be reconsidered if they wished to submit new data. It has been over one year and there has been no resubmission.
Valerie
Valerie A. Murrah, D.M.D., M.S.
Representative to the ADA Council on Scientific Affairs from the 16th
District of the ADA
Professor and Chair
Department of Diagnostic Sciences and General Dentistry
Director, Oral and Maxillofacial Pathology
University of North Carolina School of Dentistry
Chapel Hill, NC 27516
In response to an article in the Journal of Practical Hygiene, October, 2005 a special feature article mentioned that the ViziLite was the only FDA cleared technology for early detection of oral abnormalities. Obviously, this was published before Zila Pharmaceuticals was refused the ADA seal for acceptance.
I was considering incorporation of this technique for a preclinical course in a dental hygiene curriculum. I want to find several methods of detection that go beyond a visual assessment. As students learn the intra-oral exam I want them to know what procedures are available to them when an abnormality is observed and recorded. I am rethinking this and have decided I need something with a proven track record.
Casey H. Morris, RDH, MED
Adjunct Faculty
Columbus Technical College
Columbus, GA
ViziLite is the only FDA cleared product available to achieve early detection of oral abnormalities, including oral cancer, in patients at increased risk for oral cancer. I’ve used it in my practice for 2 years. ViziLite has help my hygienist and me detect lesions that were determined upon biopsy to be cancer. The lack of an ADA seal of acceptance was a matter of the ADA not understanding the difference between a screening technology(papsmear, mammogram) and a diagnostic technology. As I understand it, the seal of acceptance program has been discontinued and the company was directed not to resubmit data. ViziLite was part of the ADA health screen this year. And the ADA, based on ViziLite clinical data submitted by Zila Pharmaceuticals, assigned CDT5 codeD0431 for adjunctive prediagnostic test to identify oral abnormalities, not to include cytoscopy or biopsy.
The visual exam has been proven over40years to be ineffective at achieving early detection of oral cancer…70% of lesions identified during thevisual exam are detected in stages III/IV when the 5 year survival rate is 50%. I can live with that, and this product has helped save lives of patients across the country.
There are a number of articles that question the efficacy of ViziLite:
http://iadr.confex.com/iadr/2006Orld/techprogram/abstract_73224.htm
Conclusion: Although the acid rinse accentuated some lesions, the overall detection rate was not significantly improved. The chemiluminescent light produced reflections that made visualization more difficult, and thus the ViziLite® System was not beneficial.
In addition there are others that say that ViziLite is an expensive version of other products that can be used:
Conclusion: Chemiluminescence and LED are equally effective in the early detection of oral cancer, dysplasia and PMEL. The LED may prove to be a cheap, safe and non-invasive tool for screening high-risk individuals in clinics, health centres and remote areas devoid of modern healthcare facilities.
http://ipj.quintessenz.de/index.php?content=awards&doc=poster&select=258
All that being said, I think the best alternative might be to use a product that is cleared by the FDA to screen for oral abnormalities called VELscope:
http://www.velscope.com/
I heard that Zila is going to add more reps and drop their distributors, selling the Vizilite product direct. Great, just what we need more reps shoving this product down our throats. My question is this: Why don’t they save the money on the reps and get a clinical study other than the cerival studies they continue to site?
IMO, if you’re looking closely, you don’t need Vizilite. Should you see something, refer it out for a scapel biopsy. Better safe than sorry.
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Cavity. Thats the word no one wants to hear at the dentist’s office. A cavity (say: kah-vuh-tee) develops when a tooth decays (say: dih-kaze), or breaks down. A cavity is a hole that can grow bigger and deeper over time. WBR LeoP
Preventive maintenance of many illnesses of an oral cavity is a hygiene. Our mouth is paradise for microbes, do not give them will to live. WBR LeoP