3M Granted FDA Approval to Treat AKs T he FDA granted marketing approval for imiquimod cream 5% (Aldara) to treat clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adults. It is the first immune response modifier (IRM) to be approved for AK. It works by stimulating the immune system to recognize and respond to virus infections and tumors in the skin. It stimulates the body to produce specific cytokines, such as interferon-alpha, which then enhance cell-mediated immunity so the body can control or eliminate virus-infected cells and tumor cells. Clinical Studies FDA approval was based on positive results from two double-blind, randomized, placebo-controlled clinical trials of 436 patients with multiple AK lesions. Patients were treated with imiquimod cream or placebo twice a week for 16 weeks. At 8 weeks post-treatment, half of the patients treated with imiquimod had at least an 83% reduction in the number of AK lesions counted at baseline versus 0% in the placebo group. Almost half of the patients (46%) treated with imiquimod achieved complete clearance of all lesions compared to 3% in the placebo group. A majority of patients in the imiquimod group achieved lesion clearance of 75% or more. The studies also found that in a majority of the patients treated with imiquimod, a number of previously undetectable lesions appeared and cleared during treatment. The most frequently reported adverse reactions were local skin reactions, such as erythema, flaking/scaling/dryness, scabbing/crusting, edema, erosion/ulceration, weeping/exudates and itching/burning at the application site. Pain at the lesion site was reported by 2% of patients, and while 16% had a rest period during treatment, only 2% discontinued treatment due to local skin or application-site reactions. 3M Pharmaceuticals originally launched Aldara in 1997 to treat external genital and perianal warts. It is the company’s first IRM. According to 3M Pharmaceuticals Division, the FDA is currently reviewing a supplemental new drug application for Aldara to treat superficial basal cell carcinoma. How the Healthcare Industry is Perceived A merican adults place the greatest trust in health professionals, pharmacies and hospitals, and the least in pharmaceutical companies, managed care companies and health insurance companies, according to an online survey in January. This nationwide survey of 2,343 U.S. adults was conducted by Harris Interactive for The Wall Street Journal Online’s Health Industry Edition. When asked about their general trust of the healthcare industry to do the right thing for their patients, the majority of respondents said that they trust nurses (65%), doctors (61%) and dentists (56%) a lot. When asked about their own physician, there was a slight, though not necessarily a statistically significant difference, in responses with 63% saying they trust their own doctor a lot and 58% saying they trust their own dentist a lot. When asked who they distrusted, health insurance providers ranked the highest — 59% said their general trust for insurance companies is “not much” or “not at all,” and 29% said that their trust for their own insurance company is “not much” or “not at all.” Regarding prescription drugs, 7% said they do not trust the prescription drugs they are taking, while 41% do not trust the pharmaceutical companies. News Briefs... IVth World Congress of the International Academy of Cosmetic Dermatology… announced its meeting on July 3 to 5, 2005 at the Palais des Congres, Paris, France. For more information, visit www.iacd-paris2005.com or e-mail iacd2005@mci-group.com. Isotechnika Inc Announced… the FDA has agreed to the proposed dose range finding study for trans-ISA247 in humans. The single ascending dose study, which involves about 46 subjects, will be completed over a 6-week period by MDS Pharma Services in Phoenix, AZ. The study will be used as the foundation to determine dosing of trans-ISA247 in future clinical trials for psoriasis and for renal transplantation. Fujisawa Healthcare and Roche International Announced… that they have entered into an exclusive partnership agreement to expand the global presence of tacrolimus (Protopic), a topical ointment for the treatment of eczema. Under the agreement, Roche will be responsible for the exclusive distribution and promotion of Protopic in Mexico, Brazil, Chile, Colombia, Ecuador, Peru, Venezuela, Central America and the Caribbean. Robert S. Bolan, Ph.D., C.A.E., Appointed… Interim Executive Director of the American Academy of Dermatology (AAD), announced the AAD and the American Academy of Dermatology Association (AADA). In this interim role, Dr. Bolan will lead the AAD. The U.S. Air Force Announced… that a study has found an increased risk of prostate cancer and melanoma among Air Force veterans of the Vietnam War who sprayed the chemical defoliant Agent Orange. The study, published in the February issue of the Journal of Occupational and Environmental Medicine, found the cancer incidence to be 1.46 to 2.33 times higher among this group than among the national population. Charles W. Stiefel Was Honored… by the Dermatology Foundation of South Florida. Mr. Stiefel, Chairman, President and CEO of Stiefel Laboratories received a commemorative crystal inscribed, “Lifetime Achievement Award for outstanding philanthropic and community service and contribution to the science of dermatology.” Stiefel Laboratories also announced that Violeta Miranda has been promoted to the position of Manager of Regulatory Affairs and Quality Assurance for Latin America. She will be responsible for coordinating the multiple steps for new and renewal product registrations as required by the individual countries’ Ministries of Health. Merz Pharmaceuticals Announced… it has made Appearex, its nail-strengthening product, available in the nail care sections of CVS and Eckerd chains. To coincide with the move, the company has also given the product’s packaging a fresh, new look. Stores where the product is still only available behind the pharmacy counter will also receive the updated packaging. New FDA-Approved Laser Cellulite Treatment T he Tri-Active LaserDermology received FDA clearance in January. The triple action treatment is designed to reduce the appearance of cellulite through the combined action of mechanical massage, localized cooling and deep laser stimulation. The product can be used for cellulite treatment, pre- and post-liposuction, facial smoothing, body smoothing, enhancing microcirculation and therapeutic massage. Ear Piercing and infection C ommercial piercing of upper ear cartilage is to blame for an outbreak of Pseudomonas aeruginosa infections in Oregon, according to the results of a study published in the Journal of the American Medical Association (JAMA). For this study, investigators looked at an outbreak investigation by Oregon public health agencies, including a cohort study of people who had their ears pierced at a jewelry kiosk in August through September 2000. Investigators also discovered the infectious outbreak through environmental sampling and molecular subtyping of isolates. Confirmed cases had signs and symptoms of external ear infection, including drainage of pus or blood for at least 14 days. From 186 piercings in 118 individuals, investigators identified seven confirmed P. aeruginosa infections and 18 suspected cases. Initial treatment included antibiotics for most cases, four people were hospitalized, four underwent incision and drainage surgery and several were cosmetically deformed. It was found that upper ear cartilage piercing was more likely to result in either confirmed or suspected infection than lobe piercing. All people with confirmed infections had had their ear cartilage pierced with an open, spring-loaded piercing gun. Patient isolates were indistinguishable by molecular subtyping and matching isolates were recovered from a disinfectant on the ear studs before piercing. Researchers concluded that ear cartilage is inherently more risky than lobe piercing and physicians should respond to potential auricular chondritis and consider Pseudomonas a possible cause while they await culture results. Alcohol and Rosacea A new survey by the National Rosacea Society found that certain alcoholic beverages may aggravate rosacea more than others, but also dispelled the myth that rosacea is caused by heavy drinking. Diane Thiboutot, M.D., in a statement from the National Rosacea Society, said, “It is important that the public does not wrongly and unfairly confuse the appearance of rosacea with heavy drinking. At the same time, in managing the disorder, alcohol should be recognized as among the many common factors that can trigger or aggravate the condition in certain individuals.” The survey of more than 700 rosacea patients found that 10% said they rarely or never drink alcohol and 10% said that alcohol had no effect on their condition. Of those respondents who said alcohol did affect their appearance, red wine was listed as the top culprit with 76% saying it caused flare-ups. Also, 56% said white wine aggravated their rosacea, 33% said champagne did, 41% said beer caused rosacea flare-ups and 15% said they were affected by malt liquor or other malt-based beverages. Patients said that vodka topped the list of hard liquors to cause flare-ups (33%), followed by tequila (28%), bourbon (24%), gin (24%) and scotch (21%). For 64% of those affected by alcohol, one drink was enough to cause a reaction, while 26% indicated it took a couple of drinks and 10% of respondents said it took several. To help control their condition, 87% of respondents say they now limit their consumption of alcohol, and 90% of these respondents said it helped reduce flare-ups.
S&A News and Trends
3M Granted FDA Approval to Treat AKs T he FDA granted marketing approval for imiquimod cream 5% (Aldara) to treat clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adults. It is the first immune response modifier (IRM) to be approved for AK. It works by stimulating the immune system to recognize and respond to virus infections and tumors in the skin. It stimulates the body to produce specific cytokines, such as interferon-alpha, which then enhance cell-mediated immunity so the body can control or eliminate virus-infected cells and tumor cells. Clinical Studies FDA approval was based on positive results from two double-blind, randomized, placebo-controlled clinical trials of 436 patients with multiple AK lesions. Patients were treated with imiquimod cream or placebo twice a week for 16 weeks. At 8 weeks post-treatment, half of the patients treated with imiquimod had at least an 83% reduction in the number of AK lesions counted at baseline versus 0% in the placebo group. Almost half of the patients (46%) treated with imiquimod achieved complete clearance of all lesions compared to 3% in the placebo group. A majority of patients in the imiquimod group achieved lesion clearance of 75% or more. The studies also found that in a majority of the patients treated with imiquimod, a number of previously undetectable lesions appeared and cleared during treatment. The most frequently reported adverse reactions were local skin reactions, such as erythema, flaking/scaling/dryness, scabbing/crusting, edema, erosion/ulceration, weeping/exudates and itching/burning at the application site. Pain at the lesion site was reported by 2% of patients, and while 16% had a rest period during treatment, only 2% discontinued treatment due to local skin or application-site reactions. 3M Pharmaceuticals originally launched Aldara in 1997 to treat external genital and perianal warts. It is the company’s first IRM. According to 3M Pharmaceuticals Division, the FDA is currently reviewing a supplemental new drug application for Aldara to treat superficial basal cell carcinoma. How the Healthcare Industry is Perceived A merican adults place the greatest trust in health professionals, pharmacies and hospitals, and the least in pharmaceutical companies, managed care companies and health insurance companies, according to an online survey in January. This nationwide survey of 2,343 U.S. adults was conducted by Harris Interactive for The Wall Street Journal Online’s Health Industry Edition. When asked about their general trust of the healthcare industry to do the right thing for their patients, the majority of respondents said that they trust nurses (65%), doctors (61%) and dentists (56%) a lot. When asked about their own physician, there was a slight, though not necessarily a statistically significant difference, in responses with 63% saying they trust their own doctor a lot and 58% saying they trust their own dentist a lot. When asked who they distrusted, health insurance providers ranked the highest — 59% said their general trust for insurance companies is “not much” or “not at all,” and 29% said that their trust for their own insurance company is “not much” or “not at all.” Regarding prescription drugs, 7% said they do not trust the prescription drugs they are taking, while 41% do not trust the pharmaceutical companies. News Briefs... IVth World Congress of the International Academy of Cosmetic Dermatology… announced its meeting on July 3 to 5, 2005 at the Palais des Congres, Paris, France. For more information, visit www.iacd-paris2005.com or e-mail iacd2005@mci-group.com. Isotechnika Inc Announced… the FDA has agreed to the proposed dose range finding study for trans-ISA247 in humans. The single ascending dose study, which involves about 46 subjects, will be completed over a 6-week period by MDS Pharma Services in Phoenix, AZ. The study will be used as the foundation to determine dosing of trans-ISA247 in future clinical trials for psoriasis and for renal transplantation. Fujisawa Healthcare and Roche International Announced… that they have entered into an exclusive partnership agreement to expand the global presence of tacrolimus (Protopic), a topical ointment for the treatment of eczema. Under the agreement, Roche will be responsible for the exclusive distribution and promotion of Protopic in Mexico, Brazil, Chile, Colombia, Ecuador, Peru, Venezuela, Central America and the Caribbean. Robert S. Bolan, Ph.D., C.A.E., Appointed… Interim Executive Director of the American Academy of Dermatology (AAD), announced the AAD and the American Academy of Dermatology Association (AADA). In this interim role, Dr. Bolan will lead the AAD. The U.S. Air Force Announced… that a study has found an increased risk of prostate cancer and melanoma among Air Force veterans of the Vietnam War who sprayed the chemical defoliant Agent Orange. The study, published in the February issue of the Journal of Occupational and Environmental Medicine, found the cancer incidence to be 1.46 to 2.33 times higher among this group than among the national population. Charles W. Stiefel Was Honored… by the Dermatology Foundation of South Florida. Mr. Stiefel, Chairman, President and CEO of Stiefel Laboratories received a commemorative crystal inscribed, “Lifetime Achievement Award for outstanding philanthropic and community service and contribution to the science of dermatology.” Stiefel Laboratories also announced that Violeta Miranda has been promoted to the position of Manager of Regulatory Affairs and Quality Assurance for Latin America. She will be responsible for coordinating the multiple steps for new and renewal product registrations as required by the individual countries’ Ministries of Health. Merz Pharmaceuticals Announced… it has made Appearex, its nail-strengthening product, available in the nail care sections of CVS and Eckerd chains. To coincide with the move, the company has also given the product’s packaging a fresh, new look. Stores where the product is still only available behind the pharmacy counter will also receive the updated packaging. New FDA-Approved Laser Cellulite Treatment T he Tri-Active LaserDermology received FDA clearance in January. The triple action treatment is designed to reduce the appearance of cellulite through the combined action of mechanical massage, localized cooling and deep laser stimulation. The product can be used for cellulite treatment, pre- and post-liposuction, facial smoothing, body smoothing, enhancing microcirculation and therapeutic massage. Ear Piercing and infection C ommercial piercing of upper ear cartilage is to blame for an outbreak of Pseudomonas aeruginosa infections in Oregon, according to the results of a study published in the Journal of the American Medical Association (JAMA). For this study, investigators looked at an outbreak investigation by Oregon public health agencies, including a cohort study of people who had their ears pierced at a jewelry kiosk in August through September 2000. Investigators also discovered the infectious outbreak through environmental sampling and molecular subtyping of isolates. Confirmed cases had signs and symptoms of external ear infection, including drainage of pus or blood for at least 14 days. From 186 piercings in 118 individuals, investigators identified seven confirmed P. aeruginosa infections and 18 suspected cases. Initial treatment included antibiotics for most cases, four people were hospitalized, four underwent incision and drainage surgery and several were cosmetically deformed. It was found that upper ear cartilage piercing was more likely to result in either confirmed or suspected infection than lobe piercing. All people with confirmed infections had had their ear cartilage pierced with an open, spring-loaded piercing gun. Patient isolates were indistinguishable by molecular subtyping and matching isolates were recovered from a disinfectant on the ear studs before piercing. Researchers concluded that ear cartilage is inherently more risky than lobe piercing and physicians should respond to potential auricular chondritis and consider Pseudomonas a possible cause while they await culture results. Alcohol and Rosacea A new survey by the National Rosacea Society found that certain alcoholic beverages may aggravate rosacea more than others, but also dispelled the myth that rosacea is caused by heavy drinking. Diane Thiboutot, M.D., in a statement from the National Rosacea Society, said, “It is important that the public does not wrongly and unfairly confuse the appearance of rosacea with heavy drinking. At the same time, in managing the disorder, alcohol should be recognized as among the many common factors that can trigger or aggravate the condition in certain individuals.” The survey of more than 700 rosacea patients found that 10% said they rarely or never drink alcohol and 10% said that alcohol had no effect on their condition. Of those respondents who said alcohol did affect their appearance, red wine was listed as the top culprit with 76% saying it caused flare-ups. Also, 56% said white wine aggravated their rosacea, 33% said champagne did, 41% said beer caused rosacea flare-ups and 15% said they were affected by malt liquor or other malt-based beverages. Patients said that vodka topped the list of hard liquors to cause flare-ups (33%), followed by tequila (28%), bourbon (24%), gin (24%) and scotch (21%). For 64% of those affected by alcohol, one drink was enough to cause a reaction, while 26% indicated it took a couple of drinks and 10% of respondents said it took several. To help control their condition, 87% of respondents say they now limit their consumption of alcohol, and 90% of these respondents said it helped reduce flare-ups.
3M Granted FDA Approval to Treat AKs T he FDA granted marketing approval for imiquimod cream 5% (Aldara) to treat clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adults. It is the first immune response modifier (IRM) to be approved for AK. It works by stimulating the immune system to recognize and respond to virus infections and tumors in the skin. It stimulates the body to produce specific cytokines, such as interferon-alpha, which then enhance cell-mediated immunity so the body can control or eliminate virus-infected cells and tumor cells. Clinical Studies FDA approval was based on positive results from two double-blind, randomized, placebo-controlled clinical trials of 436 patients with multiple AK lesions. Patients were treated with imiquimod cream or placebo twice a week for 16 weeks. At 8 weeks post-treatment, half of the patients treated with imiquimod had at least an 83% reduction in the number of AK lesions counted at baseline versus 0% in the placebo group. Almost half of the patients (46%) treated with imiquimod achieved complete clearance of all lesions compared to 3% in the placebo group. A majority of patients in the imiquimod group achieved lesion clearance of 75% or more. The studies also found that in a majority of the patients treated with imiquimod, a number of previously undetectable lesions appeared and cleared during treatment. The most frequently reported adverse reactions were local skin reactions, such as erythema, flaking/scaling/dryness, scabbing/crusting, edema, erosion/ulceration, weeping/exudates and itching/burning at the application site. Pain at the lesion site was reported by 2% of patients, and while 16% had a rest period during treatment, only 2% discontinued treatment due to local skin or application-site reactions. 3M Pharmaceuticals originally launched Aldara in 1997 to treat external genital and perianal warts. It is the company’s first IRM. According to 3M Pharmaceuticals Division, the FDA is currently reviewing a supplemental new drug application for Aldara to treat superficial basal cell carcinoma. How the Healthcare Industry is Perceived A merican adults place the greatest trust in health professionals, pharmacies and hospitals, and the least in pharmaceutical companies, managed care companies and health insurance companies, according to an online survey in January. This nationwide survey of 2,343 U.S. adults was conducted by Harris Interactive for The Wall Street Journal Online’s Health Industry Edition. When asked about their general trust of the healthcare industry to do the right thing for their patients, the majority of respondents said that they trust nurses (65%), doctors (61%) and dentists (56%) a lot. When asked about their own physician, there was a slight, though not necessarily a statistically significant difference, in responses with 63% saying they trust their own doctor a lot and 58% saying they trust their own dentist a lot. When asked who they distrusted, health insurance providers ranked the highest — 59% said their general trust for insurance companies is “not much” or “not at all,” and 29% said that their trust for their own insurance company is “not much” or “not at all.” Regarding prescription drugs, 7% said they do not trust the prescription drugs they are taking, while 41% do not trust the pharmaceutical companies. News Briefs... IVth World Congress of the International Academy of Cosmetic Dermatology… announced its meeting on July 3 to 5, 2005 at the Palais des Congres, Paris, France. For more information, visit www.iacd-paris2005.com or e-mail iacd2005@mci-group.com. Isotechnika Inc Announced… the FDA has agreed to the proposed dose range finding study for trans-ISA247 in humans. The single ascending dose study, which involves about 46 subjects, will be completed over a 6-week period by MDS Pharma Services in Phoenix, AZ. The study will be used as the foundation to determine dosing of trans-ISA247 in future clinical trials for psoriasis and for renal transplantation. Fujisawa Healthcare and Roche International Announced… that they have entered into an exclusive partnership agreement to expand the global presence of tacrolimus (Protopic), a topical ointment for the treatment of eczema. Under the agreement, Roche will be responsible for the exclusive distribution and promotion of Protopic in Mexico, Brazil, Chile, Colombia, Ecuador, Peru, Venezuela, Central America and the Caribbean. Robert S. Bolan, Ph.D., C.A.E., Appointed… Interim Executive Director of the American Academy of Dermatology (AAD), announced the AAD and the American Academy of Dermatology Association (AADA). In this interim role, Dr. Bolan will lead the AAD. The U.S. Air Force Announced… that a study has found an increased risk of prostate cancer and melanoma among Air Force veterans of the Vietnam War who sprayed the chemical defoliant Agent Orange. The study, published in the February issue of the Journal of Occupational and Environmental Medicine, found the cancer incidence to be 1.46 to 2.33 times higher among this group than among the national population. Charles W. Stiefel Was Honored… by the Dermatology Foundation of South Florida. Mr. Stiefel, Chairman, President and CEO of Stiefel Laboratories received a commemorative crystal inscribed, “Lifetime Achievement Award for outstanding philanthropic and community service and contribution to the science of dermatology.” Stiefel Laboratories also announced that Violeta Miranda has been promoted to the position of Manager of Regulatory Affairs and Quality Assurance for Latin America. She will be responsible for coordinating the multiple steps for new and renewal product registrations as required by the individual countries’ Ministries of Health. Merz Pharmaceuticals Announced… it has made Appearex, its nail-strengthening product, available in the nail care sections of CVS and Eckerd chains. To coincide with the move, the company has also given the product’s packaging a fresh, new look. Stores where the product is still only available behind the pharmacy counter will also receive the updated packaging. New FDA-Approved Laser Cellulite Treatment T he Tri-Active LaserDermology received FDA clearance in January. The triple action treatment is designed to reduce the appearance of cellulite through the combined action of mechanical massage, localized cooling and deep laser stimulation. The product can be used for cellulite treatment, pre- and post-liposuction, facial smoothing, body smoothing, enhancing microcirculation and therapeutic massage. Ear Piercing and infection C ommercial piercing of upper ear cartilage is to blame for an outbreak of Pseudomonas aeruginosa infections in Oregon, according to the results of a study published in the Journal of the American Medical Association (JAMA). For this study, investigators looked at an outbreak investigation by Oregon public health agencies, including a cohort study of people who had their ears pierced at a jewelry kiosk in August through September 2000. Investigators also discovered the infectious outbreak through environmental sampling and molecular subtyping of isolates. Confirmed cases had signs and symptoms of external ear infection, including drainage of pus or blood for at least 14 days. From 186 piercings in 118 individuals, investigators identified seven confirmed P. aeruginosa infections and 18 suspected cases. Initial treatment included antibiotics for most cases, four people were hospitalized, four underwent incision and drainage surgery and several were cosmetically deformed. It was found that upper ear cartilage piercing was more likely to result in either confirmed or suspected infection than lobe piercing. All people with confirmed infections had had their ear cartilage pierced with an open, spring-loaded piercing gun. Patient isolates were indistinguishable by molecular subtyping and matching isolates were recovered from a disinfectant on the ear studs before piercing. Researchers concluded that ear cartilage is inherently more risky than lobe piercing and physicians should respond to potential auricular chondritis and consider Pseudomonas a possible cause while they await culture results. Alcohol and Rosacea A new survey by the National Rosacea Society found that certain alcoholic beverages may aggravate rosacea more than others, but also dispelled the myth that rosacea is caused by heavy drinking. Diane Thiboutot, M.D., in a statement from the National Rosacea Society, said, “It is important that the public does not wrongly and unfairly confuse the appearance of rosacea with heavy drinking. At the same time, in managing the disorder, alcohol should be recognized as among the many common factors that can trigger or aggravate the condition in certain individuals.” The survey of more than 700 rosacea patients found that 10% said they rarely or never drink alcohol and 10% said that alcohol had no effect on their condition. Of those respondents who said alcohol did affect their appearance, red wine was listed as the top culprit with 76% saying it caused flare-ups. Also, 56% said white wine aggravated their rosacea, 33% said champagne did, 41% said beer caused rosacea flare-ups and 15% said they were affected by malt liquor or other malt-based beverages. Patients said that vodka topped the list of hard liquors to cause flare-ups (33%), followed by tequila (28%), bourbon (24%), gin (24%) and scotch (21%). For 64% of those affected by alcohol, one drink was enough to cause a reaction, while 26% indicated it took a couple of drinks and 10% of respondents said it took several. To help control their condition, 87% of respondents say they now limit their consumption of alcohol, and 90% of these respondents said it helped reduce flare-ups.
