Talking Their Way to Cheaper Drug Prices
According to the results of a recent Wall Street Journal Online/Harris Interactive Healthcare Poll, many millions of patients discuss the costs of prescription drugs with their doctors, which often results in their getting a less expensive prescription.

This study, an online survey of a nationwide cross section of 2,238 adults over the age of 18, found that two in five adults say they discussed the pros and cons of different prescription drugs with their doctors. More than half of these people also said they discussed the different costs of the different drugs their doctors may prescribe, and one in seven said their doctor prescribed one drug over another because it was less expensive for them.

Welcome Aboard
We’re pleased to announce the addition of Leslie Baumann, M.D., to our editorial board. Dr. Baumann designed and created the University or Miami Cosmetic Center in 1997 and serves as its director. She is also an Associate Professor in the Department of Dermatology at the University of Miami.

News Briefs...
University of California San Francisco Calls For…study participants for an NIH funded study of why organ transplant recipients (OTRs) are so susceptible to non-melanoma skin cancers (NMSCs). Researchers need to establish a collection of specimens, a “Tissue Bank,” to serve their investigation and to start a shared resource that will be available to others. They are looking for blood samples for DNA extraction from OTRs with NMSCs and tumor samples from this patient group. Interested patients and physicians should call (800) 285-1267 or e-mail epsteine@derm.ucsf.edu.

Galderma Laboratories Announced…the appointment of Humberto C. Antunes to Executive Vice President and Chief Operating Officer of Galderma Worldwide, effective June 1, when Xavier Yon is due to retire. Currently, Mr. Antunes is the President of Galderma Laboratories and has more than 20 years experience in the pharmaceutical industry. Before being named President, he managed one of the largest and fastest-growing dermatology markets outside the United States as President of Galderma Brazil and as head of nine subsidiaries in Latin America. In the United States, Mr. Antunes will be succeeded by Albert Draaijer. Mr. Draaijer currently heads Galderma’s operations for Europe, the Middle East, Africa and Australia.

Candela Corporation Received…a 2004 Frost & Sullivan Product Quality Leadership Award for the United States medical laser markets. The award was given for Candela’s GentleLase family of products, which can be used for hair removal wrinkles, pigmented lesions and vascular lesions.

The Skin Cancer Foundation Presented…grants to support four major research projects in 2004 — three for work on melanoma. The Frederic E. Mohs Memorial Award for $10,000 was presented to John A. Zitelli, M.D., for his project, “Normal Melanocyte Density in Sun-Exposed Skin: An Immunohistochemical Evaluation.” The Henry W. Menn Memorial Award for $10,000 was presented to Mario E. Lacouture, M.D., for research into “Chemical Screening for the Identification for BRAF Inhibitors in Melanoma.” The Skin Cancer Foundation Research Award of $10,000 was given to Wei Li, Ph.D., for his project, “Identification of Melanoma Migration and Invasion-Promoting Factor(s) from the Secretion of Human Keratinocytes.” The Theodore S. Tromovitch Memorial Award of $5,000 went to Alison Ehrlich, M.D., M.H.S., for “Skin Cancer Screening for Medical Students.”

The National Rosacea Society Announced…the availability of new grants for 2004 to support research into the potential causes and other key aspects of rosacea. A high priority will be given to studies relating to such areas as he pathogenesis, progression, mechanism of action, cell biology and potential genetic factors of rosacea. Research into areas like epidemiology, predisposition, quality of life and relationships with environmental and lifestyle factors may also be funded. The deadline for submitting applications is July 15. For application forms or for more information, call (847) 382-8971 or e-mail rosaceas@aol.com.

Stiefel Laboratories Donated…more than 1,200 bottles of Sarna Lotion to National Guard soldiers serving in Iraq as part of America’s armed forces. The lotion, which cools and soothes dry and itchy skin, has been donated to troops in Florida, where Stiefel is headquartered, and New York, where the company operates a large research and manufacturing facility.

FDA News & Approvals
U.S. Marketing Approval for Sculptra
Dermik Laboratories, the U.S. dermatology arm of Aventis, announced that an FDA advisory committee unanimously recommended, with conditions, U.S. marketing approval of Sculptra (an injectable poly-L-lactic acid) for the proposed indication to correct shape and contour deficiencies resulting from facial fat loss (lipoatrophy) in HIV patients. Clinical trials with Sculptra in people with lipoatrophy associated with HIV, demonstrated noticeable results that typically lasted for up to 2 years after the first session. Adverse effects were generally limited to the site of the injection and included temporary redness and swelling and small, typically non-visible bumps.
The panel recommended approval of the product with conditions of a post-approval study, a physician training program, product use limited to HIV patients who have lipoatrophy, provision of product specification information and wording changes to the proposed label.

New Warning on Antidepressant Drugs
The FDA asked manufacturers of fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), fluvoxamine (Luvox), citalopram (Celexa), escitalopram (Lexapro), bupropion (Wellbutin), venlafaxine (Effexor), nefazondone (Serzone) and mirtazapine (Remeron) to include in their labeling a warning statement that recommends close observation of adult and pediatric patients for worsening depression or the emergence of suicidality when treated with these agents.

First Oral Fluid-Based HIV Test Approved
The FDA approved the use of oral fluid samples with a rapid HIV diagnostic test kit that provides screening results with greater than 99% accuracy in as little as 20 minutes. Before this approval in late March, all rapid HIV tests required the use of blood in order to get the fast results.
To take this test, the person being tested for HIV-1 puts the exposed absorbent pad of the device above his or her teeth and against the outer gum and swabs completely around the outer gums, both upper and lower, one time around. The tester than takes the device and inserts it into a vial containing a solution. Within 20 minutes the test will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window.

Thermage Approval
The Thermage ThermaCool System and Coupling Fluid has been given FDA Section 510(k) premarket notification of intent to market. The Thermage ThermaCool System is indicated for use in dermatologic and general surgical procedures for elctrocoagulation and hemostasis for non-invasive treatment of periorbital wrinkles and rhytids.

Elite Laser Approval
The Cynosure Apogee Elite Laser was granted Section 510(k) clearance by the FDA. The Cynosure Apogee Elite Laser is indicated for permanent hair reduction and the treatment of vascular lesions, pigmented lesions and wrinkles.

Altus Medical Handpiece
Section 510(k) clearance was granted by the FDA to Altus Medical for its Optional Infrared Handpiece. The product is indicated to provide temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied and the relaxation of muscles. It also may help muscle spasms, minor sprains and strains and minor muscular back pain.

Learner Medical Device
The FDA granted Section 510(k) approval to Lerner Medical Devices for its Levia Phototherapy System, which is indicated for use in UVB phototherapy for treatment of psoriasis, including scalp psoriasis, vitiligo, atopic dermatitis, seborrheic dermatitis and leucoderma.

Surgery Matrix
Cook Biotech’s SIS Plastic Surgery Matrix has been granted FDA Section 510(k) premarket notification of intent to market. The product is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is indicated for one-time use.

Light Age Laser
The FDA has granted Section 510(k) clearance to Light Age Inc., for it’s Light Age Q-Clear Laser. The laser is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology. The 1064nm wavelength is indicated for dark ink tattoo removal, removal of pigmented lesions, removal or lightening of hair, skin resurfacing with or without adjuvant preparation and treatment of common nevi.
The 532nm wavelength is indicated for removal of light ink (red, tan, purple and orange) tattoos, treatment of common nevi, treatment of café-au-lait spots, treatment of seborrheic keratoses, treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions.