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2002 Year in Review

December 2002

F rom practice issues to devices to drugs, 2002 offered an array of notable developments for dermatologists. In many cases, advances were evolutionary as opposed to revolutionary. To get a sense of this year’s top trends and issues, we spoke with leaders at the American Academy of Dermatology (AAD), American Society for Dermatologic Surgery (ASDS), and American Society for Laser Medicine and Surgery (ASLMS). Their insights provide an incisive look at the past year and a glimpse into what 2003 may hold. PRACTICE ISSUES Non-physician Practice of Medicine Leaders in dermatology worry about the right devices and drugs used by the wrong people. The nonphysician practice of medicine, says Stephen Mandy, M.D., president of the ASDS, presents a “serious source of concern to us.” In fact, a recent ASDS survey found that nearly 41% of respondents reported an increase in patients seeking corrective treatment for damage. The harm was caused by untrained nonphysicians in such areas as laser/light hair removal, subsurface laser/light rejuvenation techniques, and chemical peels. Dr. Mandy’s concern springs from two sources — patient safety and the economic impact on dermatologists. Technologies invented by dermatologists, he feels, should remain within the practice of medicine, along with the resulting economic benefits. Suzanne Kilmer, M.D., president of the ASLMS, worries about lasers in the hands of untrained physicians — family practice physicians, for instance, who want to increase revenues by performing laser hair removal. In turn, those doctors may train a nurse to perform the procedure. That means you have personnel doing treatments who are supervised by doctors who don’t necessarily know much about doing those treatments, and who may not even be on site, she says. As a result, complications have increased. The society’s principles state, among other things, that a “licensed medical professional employed by a physician to perform a procedure must have received appropriate documented training and education in the safe and effective use of each system.” Also, “ultimate responsibility lies with the supervising physician.” Similarly, injecting Botox is an area of concern for Neil Swanson, M.D., vice president of the AAD. The drug, he says, “needs to be used by people who understand it.” On a related note, he points to the “appropriate use of appropriate physician extenders in the dermatology practice,” such as physician assistants (PAs) and nurse practitioners (NPs). Using these professionals can help address concerns about an insufficient supply of dermatologists. Under dermatologist supervision, “they can provide diagnosis and appropriate treatment for a lot of the common skin diseases,” he says, as well as do biopsy and basic cryosurgery. Regulation of Office-based Surgery Dermatologists this past year also had to contend with forces that threatened to restrict practice. Dr. Mandy warns of a “rush to regulate” office-based surgery stemming from a false presumption of greater mortality in office-based surgery. But more mortality, he says, occurs in a hospital setting. Even beyond basic excisions and simple procedures, with such procedures as Mohs surgery and complex reconstruction, “they’re still done incredibly safely in an ambulatory setting and dermatologists’ offices,” says Dr. Swanson. The goal of dermatologists, says Dr. Swanson, is to ensure that local and nerve block anesthesia, as well as tumescent anesthesia, falls well outside the realm of what needs to be controlled. For moderate sedation or sedation that potentially changes the level of consciousness, “those are the areas where there’s more of a gray zone from a patient safety standpoint.” Lending credence to the argument for safety, an August 2002 article in Dermatologic Surgery on office surgery incidents in Florida says that “with the exception of liposuction under general anesthesia, these data do not show an emergent danger to patients. Most incidents were isolated accidents, unexpected, and probably unpreventable.” Continuing Move to Cosmetics Officials note the sway cosmetic surgery holds over physicians. Does the lure of cash-based cosmetic surgery mean that physicians who do more of these procedures will lose their clinical skills? It might, in some respect, says Dr. Kilmer. Such an emphasis will take away from general dermatology patients “and you wonder if that will cause a deficit in the availability of dermatologists.” But Dr. Swanson, who’s based in Portland, OR, sees this trend slowing. While in his location some practices are doing more cosmetic procedures, “they’re not doing it in a way that dramatically takes what was a medical dermatology practice and makes it a cosmetic dermatology practice.” They’re doing it in ways that they view as adding value in treating their patients. DEVICES Radiofrequency Marches Ahead On the device front, the use of radiofrequency (RF) devices for rejuvenation is gaining attention. The ThermaCool TC system from Thermage Inc. (Hayward, CA), for instance, is FDA-approved for general dermatologic and surgical procedures. The company’s research and development efforts focus on such applications as wrinkle reduction and skin rejuvenation. The technology, according to California–based Javier Ruiz-Esparza, M.D., who has worked closely with Thermage, heats up a volume of tissue instead of a plane of tissue, as a laser does. It offers the potential, says Dr. Kilmer, for skin tightening as well as helping with acne and acne scars. Meanwhile, Syneron Inc. (based in Israel, with an office near Toronto, Ontario) early in 2002 introduced a technology that uses RF. The firm’s Electro-Optical Synergy (ELOS) technology employs electrical (conducted RF) and optical (light or laser) energies. The company offers two families of products. Its Aurora DS is for hair removal, while the Aurora SR is intended for skin rejuvenation. The Polaris WR is for wrinkle removal, while the Polaris VL is for vascular lesion removal. To date, FDA has approved the Aurora DS for hair removal and Aurora SR for skin rejuvenation. Sounding a cautionary note, Dr. Swanson says he’s “yet to be convinced” about RF advances, though he believes the theory is of interest and awaits blinded controlled studies. Lasers Move Along This past year may not have seen dramatic developments in lasers, but dermatologists are gaining proficiency with current technologies, says Dr. Swanson. Sensors may enable physicians to preselect which type of laser will work most effectively on a vascular lesion. Dr. Kilmer says dermatologists are starting to use some of the longer-pulsed hair removal lasers (755 nm to 1064 nm) for larger, thicker, more violaceous vascular lesions. The laser can shrink bulky vascular lesions. She also sees a refining of techniques for non-ablative laser rejuvenation. Dr. Swanson cautions against viewing non-ablative lasers as a panacea. “They may play a role, but I think the role is perception as much as it is reproducible science.” DRUGS Botox “Earthquake” In the drug category, one of the top stories of 2002 involves the popularity of Botox (botulinum toxin Type A). FDA approval of Botox for cosmetic indications, according to Dr. Mandy, caused a “relative earthquake in the industry.” Expect a “continuing evolution of different uses for Botox” predicts Dr. Swanson. That could involve paralyzing other muscles of facial expression, such as the lips, as well as the neck. But don’t expect Elan Corporation’s Myobloc (botulinum toxin Type B) to pose much of a threat to Botox, says Dr. Kilmer. She notes that studies are showing that Myobloc, which acts faster than Botox, doesn’t last as long and is also more expensive than Botox. Biologic Therapies: “Tip of the Iceberg” Also notable are new immune-targeted biologic therapies to treat psoriasis and inflammatory skin disease, says Dr. Swanson. These agents, he feels, potentially provide a way to target specific mechanisms to inhibit disease with fewer treatments and side effects. “We’re just beginning, with Remicade and others, to see the tip of the iceberg,” he says. These agents might wind up treating tumors, for instance. They won’t replace standard therapy for psoriasis today. But they “will help patients who get to the point where they need fairly time- and cost-intensive therapies that have potential side effects and risks to them long term to treat a chronic disease and control it.” He also points to topical immunomodulated agents such as imiquimod (Aldara). These also hold the promise of being more specifically targeted with fewer side effects. A Few More Compounds Finally, Dr. Mandy points to the use of Allergan’s Tazorac, used in acne therapy, for anti-aging therapy. And Dr. Kilmer notes the use of SkinMedica’s Tissue Nutrient Solution (TNS) Recovery Complex, with fibroblast growth factors, which can be added to topical Vitamin C and A regimens to help with fine wrinkles.

F rom practice issues to devices to drugs, 2002 offered an array of notable developments for dermatologists. In many cases, advances were evolutionary as opposed to revolutionary. To get a sense of this year’s top trends and issues, we spoke with leaders at the American Academy of Dermatology (AAD), American Society for Dermatologic Surgery (ASDS), and American Society for Laser Medicine and Surgery (ASLMS). Their insights provide an incisive look at the past year and a glimpse into what 2003 may hold. PRACTICE ISSUES Non-physician Practice of Medicine Leaders in dermatology worry about the right devices and drugs used by the wrong people. The nonphysician practice of medicine, says Stephen Mandy, M.D., president of the ASDS, presents a “serious source of concern to us.” In fact, a recent ASDS survey found that nearly 41% of respondents reported an increase in patients seeking corrective treatment for damage. The harm was caused by untrained nonphysicians in such areas as laser/light hair removal, subsurface laser/light rejuvenation techniques, and chemical peels. Dr. Mandy’s concern springs from two sources — patient safety and the economic impact on dermatologists. Technologies invented by dermatologists, he feels, should remain within the practice of medicine, along with the resulting economic benefits. Suzanne Kilmer, M.D., president of the ASLMS, worries about lasers in the hands of untrained physicians — family practice physicians, for instance, who want to increase revenues by performing laser hair removal. In turn, those doctors may train a nurse to perform the procedure. That means you have personnel doing treatments who are supervised by doctors who don’t necessarily know much about doing those treatments, and who may not even be on site, she says. As a result, complications have increased. The society’s principles state, among other things, that a “licensed medical professional employed by a physician to perform a procedure must have received appropriate documented training and education in the safe and effective use of each system.” Also, “ultimate responsibility lies with the supervising physician.” Similarly, injecting Botox is an area of concern for Neil Swanson, M.D., vice president of the AAD. The drug, he says, “needs to be used by people who understand it.” On a related note, he points to the “appropriate use of appropriate physician extenders in the dermatology practice,” such as physician assistants (PAs) and nurse practitioners (NPs). Using these professionals can help address concerns about an insufficient supply of dermatologists. Under dermatologist supervision, “they can provide diagnosis and appropriate treatment for a lot of the common skin diseases,” he says, as well as do biopsy and basic cryosurgery. Regulation of Office-based Surgery Dermatologists this past year also had to contend with forces that threatened to restrict practice. Dr. Mandy warns of a “rush to regulate” office-based surgery stemming from a false presumption of greater mortality in office-based surgery. But more mortality, he says, occurs in a hospital setting. Even beyond basic excisions and simple procedures, with such procedures as Mohs surgery and complex reconstruction, “they’re still done incredibly safely in an ambulatory setting and dermatologists’ offices,” says Dr. Swanson. The goal of dermatologists, says Dr. Swanson, is to ensure that local and nerve block anesthesia, as well as tumescent anesthesia, falls well outside the realm of what needs to be controlled. For moderate sedation or sedation that potentially changes the level of consciousness, “those are the areas where there’s more of a gray zone from a patient safety standpoint.” Lending credence to the argument for safety, an August 2002 article in Dermatologic Surgery on office surgery incidents in Florida says that “with the exception of liposuction under general anesthesia, these data do not show an emergent danger to patients. Most incidents were isolated accidents, unexpected, and probably unpreventable.” Continuing Move to Cosmetics Officials note the sway cosmetic surgery holds over physicians. Does the lure of cash-based cosmetic surgery mean that physicians who do more of these procedures will lose their clinical skills? It might, in some respect, says Dr. Kilmer. Such an emphasis will take away from general dermatology patients “and you wonder if that will cause a deficit in the availability of dermatologists.” But Dr. Swanson, who’s based in Portland, OR, sees this trend slowing. While in his location some practices are doing more cosmetic procedures, “they’re not doing it in a way that dramatically takes what was a medical dermatology practice and makes it a cosmetic dermatology practice.” They’re doing it in ways that they view as adding value in treating their patients. DEVICES Radiofrequency Marches Ahead On the device front, the use of radiofrequency (RF) devices for rejuvenation is gaining attention. The ThermaCool TC system from Thermage Inc. (Hayward, CA), for instance, is FDA-approved for general dermatologic and surgical procedures. The company’s research and development efforts focus on such applications as wrinkle reduction and skin rejuvenation. The technology, according to California–based Javier Ruiz-Esparza, M.D., who has worked closely with Thermage, heats up a volume of tissue instead of a plane of tissue, as a laser does. It offers the potential, says Dr. Kilmer, for skin tightening as well as helping with acne and acne scars. Meanwhile, Syneron Inc. (based in Israel, with an office near Toronto, Ontario) early in 2002 introduced a technology that uses RF. The firm’s Electro-Optical Synergy (ELOS) technology employs electrical (conducted RF) and optical (light or laser) energies. The company offers two families of products. Its Aurora DS is for hair removal, while the Aurora SR is intended for skin rejuvenation. The Polaris WR is for wrinkle removal, while the Polaris VL is for vascular lesion removal. To date, FDA has approved the Aurora DS for hair removal and Aurora SR for skin rejuvenation. Sounding a cautionary note, Dr. Swanson says he’s “yet to be convinced” about RF advances, though he believes the theory is of interest and awaits blinded controlled studies. Lasers Move Along This past year may not have seen dramatic developments in lasers, but dermatologists are gaining proficiency with current technologies, says Dr. Swanson. Sensors may enable physicians to preselect which type of laser will work most effectively on a vascular lesion. Dr. Kilmer says dermatologists are starting to use some of the longer-pulsed hair removal lasers (755 nm to 1064 nm) for larger, thicker, more violaceous vascular lesions. The laser can shrink bulky vascular lesions. She also sees a refining of techniques for non-ablative laser rejuvenation. Dr. Swanson cautions against viewing non-ablative lasers as a panacea. “They may play a role, but I think the role is perception as much as it is reproducible science.” DRUGS Botox “Earthquake” In the drug category, one of the top stories of 2002 involves the popularity of Botox (botulinum toxin Type A). FDA approval of Botox for cosmetic indications, according to Dr. Mandy, caused a “relative earthquake in the industry.” Expect a “continuing evolution of different uses for Botox” predicts Dr. Swanson. That could involve paralyzing other muscles of facial expression, such as the lips, as well as the neck. But don’t expect Elan Corporation’s Myobloc (botulinum toxin Type B) to pose much of a threat to Botox, says Dr. Kilmer. She notes that studies are showing that Myobloc, which acts faster than Botox, doesn’t last as long and is also more expensive than Botox. Biologic Therapies: “Tip of the Iceberg” Also notable are new immune-targeted biologic therapies to treat psoriasis and inflammatory skin disease, says Dr. Swanson. These agents, he feels, potentially provide a way to target specific mechanisms to inhibit disease with fewer treatments and side effects. “We’re just beginning, with Remicade and others, to see the tip of the iceberg,” he says. These agents might wind up treating tumors, for instance. They won’t replace standard therapy for psoriasis today. But they “will help patients who get to the point where they need fairly time- and cost-intensive therapies that have potential side effects and risks to them long term to treat a chronic disease and control it.” He also points to topical immunomodulated agents such as imiquimod (Aldara). These also hold the promise of being more specifically targeted with fewer side effects. A Few More Compounds Finally, Dr. Mandy points to the use of Allergan’s Tazorac, used in acne therapy, for anti-aging therapy. And Dr. Kilmer notes the use of SkinMedica’s Tissue Nutrient Solution (TNS) Recovery Complex, with fibroblast growth factors, which can be added to topical Vitamin C and A regimens to help with fine wrinkles.

F rom practice issues to devices to drugs, 2002 offered an array of notable developments for dermatologists. In many cases, advances were evolutionary as opposed to revolutionary. To get a sense of this year’s top trends and issues, we spoke with leaders at the American Academy of Dermatology (AAD), American Society for Dermatologic Surgery (ASDS), and American Society for Laser Medicine and Surgery (ASLMS). Their insights provide an incisive look at the past year and a glimpse into what 2003 may hold. PRACTICE ISSUES Non-physician Practice of Medicine Leaders in dermatology worry about the right devices and drugs used by the wrong people. The nonphysician practice of medicine, says Stephen Mandy, M.D., president of the ASDS, presents a “serious source of concern to us.” In fact, a recent ASDS survey found that nearly 41% of respondents reported an increase in patients seeking corrective treatment for damage. The harm was caused by untrained nonphysicians in such areas as laser/light hair removal, subsurface laser/light rejuvenation techniques, and chemical peels. Dr. Mandy’s concern springs from two sources — patient safety and the economic impact on dermatologists. Technologies invented by dermatologists, he feels, should remain within the practice of medicine, along with the resulting economic benefits. Suzanne Kilmer, M.D., president of the ASLMS, worries about lasers in the hands of untrained physicians — family practice physicians, for instance, who want to increase revenues by performing laser hair removal. In turn, those doctors may train a nurse to perform the procedure. That means you have personnel doing treatments who are supervised by doctors who don’t necessarily know much about doing those treatments, and who may not even be on site, she says. As a result, complications have increased. The society’s principles state, among other things, that a “licensed medical professional employed by a physician to perform a procedure must have received appropriate documented training and education in the safe and effective use of each system.” Also, “ultimate responsibility lies with the supervising physician.” Similarly, injecting Botox is an area of concern for Neil Swanson, M.D., vice president of the AAD. The drug, he says, “needs to be used by people who understand it.” On a related note, he points to the “appropriate use of appropriate physician extenders in the dermatology practice,” such as physician assistants (PAs) and nurse practitioners (NPs). Using these professionals can help address concerns about an insufficient supply of dermatologists. Under dermatologist supervision, “they can provide diagnosis and appropriate treatment for a lot of the common skin diseases,” he says, as well as do biopsy and basic cryosurgery. Regulation of Office-based Surgery Dermatologists this past year also had to contend with forces that threatened to restrict practice. Dr. Mandy warns of a “rush to regulate” office-based surgery stemming from a false presumption of greater mortality in office-based surgery. But more mortality, he says, occurs in a hospital setting. Even beyond basic excisions and simple procedures, with such procedures as Mohs surgery and complex reconstruction, “they’re still done incredibly safely in an ambulatory setting and dermatologists’ offices,” says Dr. Swanson. The goal of dermatologists, says Dr. Swanson, is to ensure that local and nerve block anesthesia, as well as tumescent anesthesia, falls well outside the realm of what needs to be controlled. For moderate sedation or sedation that potentially changes the level of consciousness, “those are the areas where there’s more of a gray zone from a patient safety standpoint.” Lending credence to the argument for safety, an August 2002 article in Dermatologic Surgery on office surgery incidents in Florida says that “with the exception of liposuction under general anesthesia, these data do not show an emergent danger to patients. Most incidents were isolated accidents, unexpected, and probably unpreventable.” Continuing Move to Cosmetics Officials note the sway cosmetic surgery holds over physicians. Does the lure of cash-based cosmetic surgery mean that physicians who do more of these procedures will lose their clinical skills? It might, in some respect, says Dr. Kilmer. Such an emphasis will take away from general dermatology patients “and you wonder if that will cause a deficit in the availability of dermatologists.” But Dr. Swanson, who’s based in Portland, OR, sees this trend slowing. While in his location some practices are doing more cosmetic procedures, “they’re not doing it in a way that dramatically takes what was a medical dermatology practice and makes it a cosmetic dermatology practice.” They’re doing it in ways that they view as adding value in treating their patients. DEVICES Radiofrequency Marches Ahead On the device front, the use of radiofrequency (RF) devices for rejuvenation is gaining attention. The ThermaCool TC system from Thermage Inc. (Hayward, CA), for instance, is FDA-approved for general dermatologic and surgical procedures. The company’s research and development efforts focus on such applications as wrinkle reduction and skin rejuvenation. The technology, according to California–based Javier Ruiz-Esparza, M.D., who has worked closely with Thermage, heats up a volume of tissue instead of a plane of tissue, as a laser does. It offers the potential, says Dr. Kilmer, for skin tightening as well as helping with acne and acne scars. Meanwhile, Syneron Inc. (based in Israel, with an office near Toronto, Ontario) early in 2002 introduced a technology that uses RF. The firm’s Electro-Optical Synergy (ELOS) technology employs electrical (conducted RF) and optical (light or laser) energies. The company offers two families of products. Its Aurora DS is for hair removal, while the Aurora SR is intended for skin rejuvenation. The Polaris WR is for wrinkle removal, while the Polaris VL is for vascular lesion removal. To date, FDA has approved the Aurora DS for hair removal and Aurora SR for skin rejuvenation. Sounding a cautionary note, Dr. Swanson says he’s “yet to be convinced” about RF advances, though he believes the theory is of interest and awaits blinded controlled studies. Lasers Move Along This past year may not have seen dramatic developments in lasers, but dermatologists are gaining proficiency with current technologies, says Dr. Swanson. Sensors may enable physicians to preselect which type of laser will work most effectively on a vascular lesion. Dr. Kilmer says dermatologists are starting to use some of the longer-pulsed hair removal lasers (755 nm to 1064 nm) for larger, thicker, more violaceous vascular lesions. The laser can shrink bulky vascular lesions. She also sees a refining of techniques for non-ablative laser rejuvenation. Dr. Swanson cautions against viewing non-ablative lasers as a panacea. “They may play a role, but I think the role is perception as much as it is reproducible science.” DRUGS Botox “Earthquake” In the drug category, one of the top stories of 2002 involves the popularity of Botox (botulinum toxin Type A). FDA approval of Botox for cosmetic indications, according to Dr. Mandy, caused a “relative earthquake in the industry.” Expect a “continuing evolution of different uses for Botox” predicts Dr. Swanson. That could involve paralyzing other muscles of facial expression, such as the lips, as well as the neck. But don’t expect Elan Corporation’s Myobloc (botulinum toxin Type B) to pose much of a threat to Botox, says Dr. Kilmer. She notes that studies are showing that Myobloc, which acts faster than Botox, doesn’t last as long and is also more expensive than Botox. Biologic Therapies: “Tip of the Iceberg” Also notable are new immune-targeted biologic therapies to treat psoriasis and inflammatory skin disease, says Dr. Swanson. These agents, he feels, potentially provide a way to target specific mechanisms to inhibit disease with fewer treatments and side effects. “We’re just beginning, with Remicade and others, to see the tip of the iceberg,” he says. These agents might wind up treating tumors, for instance. They won’t replace standard therapy for psoriasis today. But they “will help patients who get to the point where they need fairly time- and cost-intensive therapies that have potential side effects and risks to them long term to treat a chronic disease and control it.” He also points to topical immunomodulated agents such as imiquimod (Aldara). These also hold the promise of being more specifically targeted with fewer side effects. A Few More Compounds Finally, Dr. Mandy points to the use of Allergan’s Tazorac, used in acne therapy, for anti-aging therapy. And Dr. Kilmer notes the use of SkinMedica’s Tissue Nutrient Solution (TNS) Recovery Complex, with fibroblast growth factors, which can be added to topical Vitamin C and A regimens to help with fine wrinkles.