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PREMALIGNANT LESIONS
C O M M E N T A R Y GUEST EDITORIAL
LETTERS
J
ADA welcomes letters from readers on articles that have appeared in The Journal. The Journal reserves the right to edit all communications and requires that all letters be signed. Letters must be no more than 550 words and must cite no more than five references. No illustrations will be accepted. A letter concerning a recent JADA article will have the best chance of acceptance if it is received within two months of the article’s publication. For instance, a letter about an article that appeared in April JADA usually will be considered for acceptance only until the end of June. You may submit your
letter via e-mail to “jadaletters@ ada.org”; by fax to 1-312-440-3538; or by mail to 211 E. Chicago Ave., Chicago, Ill. 60611-2678. By sending a letter to the editor, the author acknowledges and agrees that the letter and all rights of the author in the letter sent become the property of The Journal. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of the Association. Brevity is appreciated. PREMALIGNANT LESIONS
I read with great interest Dr. Joel Epstein and colleagues’ December JADA article, “A Survey of the Current Approaches to Diagnosis and Management of Oral Premalignant Lesions” (Epstein JB, Gorsky JADA, Vol. 139
M, Fischer D, Gupta A, Epstein M, Elad S. JADA 2007;138[12]:1555-1562). The authors succinctly summarized our limitations in predicting which suspicious lesion will progress to cancer. Reference was made in the article to various adjunctive procedures and devices such as the brush biopsy, toluidine blue staining and two light-based devices available to the dentist to assess oral mucosal lesions. While the authors expressed no firm recommendations regarding their use, I believe further clarification on their yet-to-be-proven applicability in dental practice is in order. Practitioners often ask me, http://jada.ada.org
Copyright © 2008 American Dental Association. All rights reserved.
April 2008
395
L E T T E R S
“Should I use product ‘X’?” or, “Do you use product ‘Y’ routinely?” My current answer is that, given the present lack of scientific study validating their application as routine screening adjuncts, I can neither recommend nor discourage their use. The response from the inquiring practitioner is often, “But they are FDA approved.” The reality is none of these procedures or devices have been vetted through the U.S. Food and Drug Administration (FDA) approval process for a new device. It should be noted here that the brush biopsy procedure (OralCDx, CDx Laboratories, Suffern, N.Y.) is a refined and improved cytology assessment accomplished by a centralized laboratory and not subject to FDA regulation. To illustrate the FDA’s true involvement concerning these devices, let us look at some of the light-based products available: ViziLite Plus with TBlue630 (Zila Pharmaceuticals, Phoenix), Microlux/DL (AdDent, Danbury, Conn.) and the VELscope (LED Dental, White Rock, British Columbia, Canada). They have all been cleared for use based on their equivalency to a predicate light source marketed in interstate commerce before May 28, 1976. Essentially, the first such product cleared as equivalent by the FDA was the Speculite Disposable Vaginal Light (Trylon Associates, Harbor City, Calif.) in 1985. These devices are not considered as standard of care in either the gynecological or dental professions, and generally are considered experimental, investigational or unproven by insurance carriers.1-4 Similar concerns about the 396
JADA, Vol. 139
http://jada.ada.org
routine use of toluidine blue staining and brush biopsy to assess oral lesions in dental practice also exist. It may very well be that one or all of these adjunctive techniques may eventually serve an integral role in our ability to identify suspicious oral lesions in dental practice. Let me also emphasize that these products are being legally marketed to the dental profession, and the manufacturers are to be commended for their efforts to promote oral cancer awareness. However, for now, the operative word regarding their routine use is “may.” Until properly designed clinical studies to determine such issues as sensitivity and specificity, ease of use and cost benefit, the uncertainty about the true value of these techniques will continue.5-6 Michaell A. Huber, DDS Associate Professor Head, Division of Oral Medicine Dental Diagnostic Science Dental School The University of Texas Health Science Center at San Antonio 1. National Guideline Clearing House. Screening for cervical cancer: recommendations and rationale. “www.guideline.gov/ summary/summary.aspx?doc_id=3532&nbr= 002758&string=cervical+AND+cancer”. Accessed Dec.19, 2007. 2. National Guideline Clearing House. Screening for oral cancer: recommendation statement. “www.guideline.gov/summary/ summary.aspx?doc_id=4775&nbr=003454& string=oral+AND+cancer”. Accessed Dec. 19, 2007. 3. CIGNA Healthcare. Cervical cancer screening technologies. “www.cigna.com/ customer_care/healthcare_professional/ coverage_positions/medical/mm_0127_ coveragepositioncriteria_cervical_cancer_ screening_technologies.pdf”. Accessed Dec. 19/2007. 4. CIGNA Healthcare. ViziLite and VELscope oral screening systems. “www. cigna.com/customer_care/healthcare_ professional/coverage_positions/medical/mm_ 0372_coveragepositioncriteria_vizilite_oral_ screening_system.pdf”. Accessed Dec. 19, 2007. 5. Wright TC, Denny L, Kuhn L, Goldie S. Use of visual screening methods for cervical cancer screening. Obstet Gynecol Clin North Am 2002;29(4):701-734. 6. Lingen MW. Oral cancer screening aids:
where is the science? Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2007;103(2): 153-154.
Authors’ response: We thank Dr. Huber for his letter. The purpose of our survey was to assess the standards of care in diagnosis and management at the time the survey was conducted. We believe this article is a first step in examining current standards of care and, potentially, a beginning in developing management guidelines. As we noted in the article, the survey was conducted before the U.S. Food and Drug Administration’s (FDA’s) “clearance” of some of the devices that have been subsequently cleared, making these available for clinical use. As Dr. Huber notes, FDA clearance of devices can be based on predicate devices, where substantial equivalency is shown and safety is not identified as a concern. The provider must be aware that device clearance is not equal to the stringency of drug approval. We agree that recommendations for use of the available adjuncts are needed in the community. We also agree that recommendations for use of adjuncts in diagnosis may have different outcomes in different patient populations and with different providers. A systematic review of current studies has been undertaken to assess the utility of adjuncts in detection and diagnosis and, when completed, may provide additional guidance. While there is increasing evidence being developed through continuing studies, more study needs to be done in the clinical environments in which they are anticipated to be applied. Organizations should develop guidelines based on the best
April 2008
Copyright © 2008 American Dental Association. All rights reserved.
LETTERS
J
ADA welcomes letters from readers on articles that have appeared in The Journal. The Journal reserves the right to edit all communications and requires that all letters be signed. Letters must be no more than 550 words and must cite no more than five references. No illustrations will be accepted. A letter concerning a recent JADA article will have the best chance of acceptance if it is received within two months of the article’s publication. For instance, a letter about an article that appeared in April JADA usually will be considered for acceptance only until the end of June. You may submit your
letter via e-mail to “jadaletters@ ada.org”; by fax to 1-312-440-3538; or by mail to 211 E. Chicago Ave., Chicago, Ill. 60611-2678. By sending a letter to the editor, the author acknowledges and agrees that the letter and all rights of the author in the letter sent become the property of The Journal. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of the Association. Brevity is appreciated. PREMALIGNANT LESIONS
I read with great interest Dr. Joel Epstein and colleagues’ December JADA article, “A Survey of the Current Approaches to Diagnosis and Management of Oral Premalignant Lesions” (Epstein JB, Gorsky JADA, Vol. 139
M, Fischer D, Gupta A, Epstein M, Elad S. JADA 2007;138[12]:1555-1562). The authors succinctly summarized our limitations in predicting which suspicious lesion will progress to cancer. Reference was made in the article to various adjunctive procedures and devices such as the brush biopsy, toluidine blue staining and two light-based devices available to the dentist to assess oral mucosal lesions. While the authors expressed no firm recommendations regarding their use, I believe further clarification on their yet-to-be-proven applicability in dental practice is in order. Practitioners often ask me, http://jada.ada.org
Copyright © 2008 American Dental Association. All rights reserved.
April 2008
395
L E T T E R S
“Should I use product ‘X’?” or, “Do you use product ‘Y’ routinely?” My current answer is that, given the present lack of scientific study validating their application as routine screening adjuncts, I can neither recommend nor discourage their use. The response from the inquiring practitioner is often, “But they are FDA approved.” The reality is none of these procedures or devices have been vetted through the U.S. Food and Drug Administration (FDA) approval process for a new device. It should be noted here that the brush biopsy procedure (OralCDx, CDx Laboratories, Suffern, N.Y.) is a refined and improved cytology assessment accomplished by a centralized laboratory and not subject to FDA regulation. To illustrate the FDA’s true involvement concerning these devices, let us look at some of the light-based products available: ViziLite Plus with TBlue630 (Zila Pharmaceuticals, Phoenix), Microlux/DL (AdDent, Danbury, Conn.) and the VELscope (LED Dental, White Rock, British Columbia, Canada). They have all been cleared for use based on their equivalency to a predicate light source marketed in interstate commerce before May 28, 1976. Essentially, the first such product cleared as equivalent by the FDA was the Speculite Disposable Vaginal Light (Trylon Associates, Harbor City, Calif.) in 1985. These devices are not considered as standard of care in either the gynecological or dental professions, and generally are considered experimental, investigational or unproven by insurance carriers.1-4 Similar concerns about the 396
JADA, Vol. 139
http://jada.ada.org
routine use of toluidine blue staining and brush biopsy to assess oral lesions in dental practice also exist. It may very well be that one or all of these adjunctive techniques may eventually serve an integral role in our ability to identify suspicious oral lesions in dental practice. Let me also emphasize that these products are being legally marketed to the dental profession, and the manufacturers are to be commended for their efforts to promote oral cancer awareness. However, for now, the operative word regarding their routine use is “may.” Until properly designed clinical studies to determine such issues as sensitivity and specificity, ease of use and cost benefit, the uncertainty about the true value of these techniques will continue.5-6 Michaell A. Huber, DDS Associate Professor Head, Division of Oral Medicine Dental Diagnostic Science Dental School The University of Texas Health Science Center at San Antonio 1. National Guideline Clearing House. Screening for cervical cancer: recommendations and rationale. “www.guideline.gov/ summary/summary.aspx?doc_id=3532&nbr= 002758&string=cervical+AND+cancer”. Accessed Dec.19, 2007. 2. National Guideline Clearing House. Screening for oral cancer: recommendation statement. “www.guideline.gov/summary/ summary.aspx?doc_id=4775&nbr=003454& string=oral+AND+cancer”. Accessed Dec. 19, 2007. 3. CIGNA Healthcare. Cervical cancer screening technologies. “www.cigna.com/ customer_care/healthcare_professional/ coverage_positions/medical/mm_0127_ coveragepositioncriteria_cervical_cancer_ screening_technologies.pdf”. Accessed Dec. 19/2007. 4. CIGNA Healthcare. ViziLite and VELscope oral screening systems. “www. cigna.com/customer_care/healthcare_ professional/coverage_positions/medical/mm_ 0372_coveragepositioncriteria_vizilite_oral_ screening_system.pdf”. Accessed Dec. 19, 2007. 5. Wright TC, Denny L, Kuhn L, Goldie S. Use of visual screening methods for cervical cancer screening. Obstet Gynecol Clin North Am 2002;29(4):701-734. 6. Lingen MW. Oral cancer screening aids:
where is the science? Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2007;103(2): 153-154.
Authors’ response: We thank Dr. Huber for his letter. The purpose of our survey was to assess the standards of care in diagnosis and management at the time the survey was conducted. We believe this article is a first step in examining current standards of care and, potentially, a beginning in developing management guidelines. As we noted in the article, the survey was conducted before the U.S. Food and Drug Administration’s (FDA’s) “clearance” of some of the devices that have been subsequently cleared, making these available for clinical use. As Dr. Huber notes, FDA clearance of devices can be based on predicate devices, where substantial equivalency is shown and safety is not identified as a concern. The provider must be aware that device clearance is not equal to the stringency of drug approval. We agree that recommendations for use of the available adjuncts are needed in the community. We also agree that recommendations for use of adjuncts in diagnosis may have different outcomes in different patient populations and with different providers. A systematic review of current studies has been undertaken to assess the utility of adjuncts in detection and diagnosis and, when completed, may provide additional guidance. While there is increasing evidence being developed through continuing studies, more study needs to be done in the clinical environments in which they are anticipated to be applied. Organizations should develop guidelines based on the best
April 2008
Copyright © 2008 American Dental Association. All rights reserved.