FDA Approvals & News
Recall on Fluorouracil Injection
American Pharmaceutical Partners has issued a recall of its fluorouracil for injection in 50 mg/ml (500 mg/10 ml single dose vials). Used as a chemotherapeutic agent, the drug is being recalled because of a potential for invisible glass particles to be present within the vials.
Only vials with the product code 101710 are affected — the company’s other fluorouracil products are manufactured in a different type of glass vial.
For more information about this recall, contact the company’s quality assurance department at (847) 939-8138.

Tentative Approval for First Generic Topical MetronidazoleFougera, a manufacturer of dermatologic and ophthalmic pharmaceuticals, has received tentative approval from the FDA to introduce the first generic version of metronidazole topical gel (0.75%), which is indicated for treating rosacea.
Presently, the product patent is held by Galderma, and the patent expires in June 2006. Fougera has received more topical generic FDA approvals than any other company during the past 6 years, according to a company statement.

New Indication for CoolTouch Endovenous Laser
The CoolTouch CTEV 1320 nm laser system has been granted 510(k) clearance from the FDA for the treatment of reflux of the small saphenous vein. The company had received initial clearance by the FDA in fall 2004 for treating reflux of the great saphenous vein.
As the only 1320 nm Nd:YAG endovenous laser, the CTEV targets water in the vein wall, which allows the device to successfully close the affected veins. Other lasers target hemoglobin.
This recent clearance will enable a wider range of patients who can undergo treatment for varicose veins with this method. According to the company, at least 20% of patients (millions of people) affected by varicose veins have them because of venous disease in the non-great saphenous veins. Non-great saphenous veins, which include the small saphenous vein, are a frequent, but often underdiagnosed, cause of varicose veins.

Other Drug News
Tacrolimus Effectively Treats AD in Children
Children as young as 2 years of age who have mild-to-moderate atopic dermatitis can benefit from treatment with tacrolimus (Protopic), according to the September issue of the journal Pediatrics.
Dermatologist Lawrence Schachner, M.D., and colleagues from the University of Miami conducted a placebo-controlled study of 317 pediatric patients who had mild-to-moderate atopic dermatitis. Patients were randomized to receive either a placebo or monotherapy with tacrolimus ointment 0.03%. Investigators observed the following study results:
• Twice as many patients treated with tacrolimus vs. placebo (50.6% vs. 25.8%, respectively) were successfully treated.
• As early as day 4 of the study, 19% of patients treated with tacrolimus were clear or almost clear of their AD.
• In addition, overall improvement in AD by day 4 was significantly greater for patients treated with tacrolimus vs. placebo (32.5% vs. 16.3%).
• Tacrolimus was most effective in treating AD in the head and neck regions of patients. Patients achieved a 59.1%
improvement from baseline to study’s end, compared with those in the placebo group, of whom 3.9% reported worsening of their AD.

What Patients Think About the Care They Receive
According to a recent survey, nearly three-quarters (72%) of U.S. adults indicated that they perceived that patients who have medical conditions experienced problems because they were overtreated — either receiving treatment that was too aggressive for their respective conditions or receiving too many treatments. Results were based on a recent Wall Street Journal/Harris Interactive Health-Care Poll of 2,286 U.S. adults, who were polled online.
The reasons given for why physicians may overtreat patients included the following:
• Doctors were concerned about lawsuits (53%).
• Doctors were overtreating to make more money (45%).
• Doctors were doing it to meet patients’ demands (45%).
• Doctors were overtreating just because it was the easiest and fastest way to treat the patient (31%).
• Overtreatment occurred because of misleading information doctors received from prescription drug and medical device companies (30%).
• Doctors were overtreating because they’d misdiagnosed patients (27%).
• Overtreatment occurred because the doctor was trying to give patients more reason to hope (16%).
More than half (52%) of study participants indicated that they had either questioned or ignored their doctor’s recommendations, taking the following actions:
• Avoided filling a prescription (31%) because they thought it was unnecessary.
• Sought a second opinion from another physician (21%) because they thought the first opinion was too aggressive.
• Did not undergo a diagnostic test their doctor had recommended (16%) because they felt it wasn’t needed.
• Avoided undergoing a surgical procedure (10%) because they didn’t think it was necessary.
• Began seeing a new physician (9%) because they felt their former doctor’s approach was too aggressive.

Promoting Your Practice to Patients
If you’re new in practice or you’ve decided to expand your practice in the community, you might want to consider hiring a public relations firm to develop a comprehensive marketing plan. But, where do you begin?
Katherine Rothman, President and CEO of KMR Communications, a Manhattan public relations firm that specializes in beauty and medical clientele, offered this advice for choosing a PR firm to best suit your needs.
• Ask the firm to provide examples of successful campaign tactics.
• Request examples of print and media coverage the firm has provided for other similar clients.
• Get a reasonable estimate of frequency of media coverage.
• Make sure to know which markets will be targeted by the firm so that you can assess whether the right audience will receive your message.
• Ask for a list of references of other clients the firm has served so that you can contact them.
• Learn what other companies the firm handles. You don’t want to be a small fish in a big pond.
• Make sure there are no conflicts of interest — i.e., you’d want to determine whether your closest competitor is being handled by the same firm.
• Know the account executive to client ratio and how much time will be devoted to your account on a weekly and monthly basis.
• Ask whether you’ll be provided with weekly written progress reports.
• Determine whether the firm will charge you for any additional expenses such as monthly disbursements.
• Before signing on with the PR firm, ask for a written proposal that will outline a campaign strategy and explain the company’s client policy.

Primary Care Pay-For-Performance Standards Set
The National Quality Forum, the group charged by Congress with endorsing the measures upon which Medicare will base payments for primary care physicians, recently set 36 quality standards for outpatient care. The group drew 24 of the measures from the American Medial Association’s Physician Consortium for Performance Improvement and 12 from the National Committee for Quality Assurance.
The measures cover the areas of asthma and respiratory illness, behavioral health and depression, bone conditions, heart disease, hypertension, prenatal care, preventive care, immunization and screening. The measures are timed for use in insurance contracts beginning January 2006 and are intended to reduce the redundancy of differing performance measures used by various health plans.
According to a report in American Medical News, although the American Medical Association (AMA) does not object to most of the measures, it is still unhappy with legislation in Congress that would withhold 1% to 2% of physician payments for redistribution to top performers. According to the report, Recent testimony before the Medicare Payment Advisory Commission by witnesses representing a major insurer, a group of community health plans and a quality improvement nonprofit, urged Congress to come up with more money to pay physicians who do well on quality measures and not to take money away from those who don’t.

Acne and Teen Girls
A recent survey found that 53% of teenage girls agreed that having pimple-free skin makes being a teenager easier. The survey, “Skin is In/Back to School,” was a national on-line poll of 750 girls aged 13 to 17 years that was conducted by the American Counseling Association and sponsored by Dermik Laboratories. Of those responding to the survey, 52% reported that not having pimples makes them “prettier” and 48% said it makes them feel “more confident.”
The survey also found that while not having acne was important to teens, many were confused about to handle breakouts. Thirty percent reported popping pimples even though 40% said they knew that this could contribute to further breakouts. Also, 40% reported that they think frequently washing their face will keep pimples at bay during the summer months. And while 41% say they use cover-up makeup during breakouts, only 17% said they would go to see a doctor or dermatologist when their skin breaks out.

In Brief...
Galderma Laboratories Announced…the appointment of Ronald W. Gottschalk, M.D., as its new Medical Director. Dr. Gottschalk’s duties will include management of clinical studies dedicated to the support of new and existing products in the United States and Canada. He will also be responsible for publications and pharmacovigilence for North America.

Physician’s Choice of Arizona Celebrated…its 15th anniversary with the announcement of its new name — PCA Advanced Skin Care Systems. The company says the new corporate identity was selected to embody the company’s growing global presence and to unify brand recognition of the ever-expanding family of professional treatments and products developed and marketed by the company.

Altana Pharma AG has acquired … the prescription dermatology business from GlaxoSmithKline Consumer Healthcare, a division of GlaxoSmithKline Corporation. PharmaDerm, a division of Altana Inc, will manufacture and market the following former GSK products: the synthetic steroid alclometasone dipropionate (Aclovate), the anti-inflammatory fluticasone propionate (Cutivate), the antibiotic erythromycin (Emgel), the anti-fungal oxiconazole nitrate (Oxistat), and the anti-inflammatory clobetasol propionate (Temovate).

Aqua Pharmaceuticals Announced…it has entered into a U.S. licensing agreement with Watson Pharmaceuticals to market Cordran (flurandrenolide), a family of topical steroids and the antibiotic Monodox (doxycycline monohydrate) 50-mg and 100-mg capsules. Aqua Pharma-ceuticals will also promote Watson’s Cordran Tape product. Aqua will focus its efforts on selling to physicians prescribing topical steroids and oral antibiotics and will be calling on dermatologists nationwide.

Stiefel Laboratories Announced…two new agreements. Stiefel Laboratories and Grupo Uriach, a Spanish pharmaceutical company focused on drug discovery and early drug development, have entered into a licensing agreement to develop and market a new chemical entity, UR-9825 (albaconazole), an oral broad-spectrum anti-fungal that has shown a superior clinical profile in phase II trials. Also, Stiefel and Foamix have entered into an agreement to develop a new foam product for the treatment of scabies. Under the terms of the agreement, Foamix will develop the foam formulations and Stiefel will conduct clinical trials and the commercialization of the product in the United States.

Thermage Announced that it Received…an approved investigational device exemption from the FDA to conduct the first in a series of multi-center studies in the United States to evaluate the use of Thermage technology for off-face indications, specifically to treat the upper arms. A multi-center study in Europe is already underway at three clinical sites in Germany, Italy and Belgium using the Thermage procedure to treat the upper arms.

International Hyperhidrosis Society Relaunched… its Web site, www.sweathelp.org. The society explained that it upgraded its site to accommodate the increase in the number of daily visitors to the site and provide them with the most accurate information available on coping strategies, medical advances and treatment options. The relaunched site was made possible through a grant from Secret antiperspirant.

Syneron Announced The Sale…of $6 million worth of equipment to American Laser Centers (ALC). ALC decided to expand the activity of its clinics from hair removal and skin rejuvenation to also include cellulite treatment in its more than 100 physician-supervised locations. ALC ordered 100 Syneron platforms, including the VelaSmooth and the Aurora System.
Foamix Announced the Commencement…of a phase II trial of its betamethasone 0.12% emollient foam for the treatment of psoriasis. The study is due to be completed in November. The company also announced the start of a phase II, placebo-controlled trial of TerbiFoam 2% Foam for the treatment of athlete’s foot. The study will include 30 patients and will be conducted by Dr. Avner Shemer.

Psoriasis Advocacy Group Urges FDA…to support the approval of abatacept for use by rheumatoid arthritis patients. Psoriasis Cure Now, the nonprofit patient advocacy group, hopes the biologic drug, which would be marketed by Bristol-Myers Squibb under the brand name Orencia, may also provide the psoriasis community with an additional treatment option.