Have You Ever Withheld Treatment Information from Patients?

A high percentage of doctors don’t discuss potential treatment options with their patients if those options aren’t covered by the patient’s insurance plan, according to a survey that was analyzed in the July edition of the medical journal Health Affairs.
Even though the survey had been conducted in 1998 and 1999, the article’s lead author said that the results were even more relevant in today’s medical practices where doctors have increasing pressure in deciding which services and treatments to recommend and offer.
According to the survey, 31% of doctors said they hadn’t offered “useful care to patients because of health plan coverage rules at least ‘sometimes.’”
Of this group of respondents, 35% said they withheld information more frequently than they had 5 years earlier.
When physicians were faced with situations in which patients asked them to manipulate health plan rules to provide treatments not covered, physicians were most likely to withhold information.
In addition, physicians who had a large number of Medicaid patients were more likely to withhold treatment information because of coverage rules.

Dermatology: A Beastly Profession

Have you ever noticed that there are a lot of beasts lurking in the shadows of the dermatology profession? And these monsters seem to be multiplying. Even though they may seem scary at first, you have to admit that some of them are kinda cute, too.

The Eczema Beast from Fujisawa (promotion for tacrolimus [Protopic])

The Inflammitch from Ferndale Laboratories (promotion for hydrocortisone acetate 1% or 2.5% and pramoxine HCl [Pramosone])

The Itchysaurus from Beiersdorf (promotion for Eucerin Itch-Relief Moisturizing Spray)

Digger the Dermatophyte from Novartis (promotion for terbinafine HCl tablets [Lamisil])

In Brief

FDA Announces…
new medical device fee rates for fiscal year 2004. The fees will be used to achieve the FDA’s long-term goal of making substantial improvements in device review performance. The device industry has been growing in size and in technical complexity and has the potential for developing a broader range of safer, more effective treatments than ever before. The fees should help reduce the average time for marketing approval so that patients can have access to safe and effective new devices sooner. Visit www.fda.gov for more information.

Study on Hyperhydrosis…
by researchers at St. Louis University found that about 7.8 million Americans are living with this condition, which can result in anxiety, depression, isolation and a reduced quality of life. The results, which were presented at the Annual American Academy of Dermatology meeting in March, are based on a survey of 150,000 households in the United States, the largest U.S. study on hyperhydrosis so far. Researchers had an 80% response rate to their survey. Of those with the disease, 90% reported that sweating interfered with their life – either at work, socially or romantically. Patients may not know about available treatment options, such as oral or topical medications, surgery or Botox.

ICN Expands Kinerase Product Line…
by signing a license of agreement to amend its current manufacturing license with Senetek PLC. The expanded contract adds five new products to the Kinerase line, including new serum and cream formulations with highly stabilized vitamin C, a Kinerase sunscreen formulation and new cream and lotion formulations. ICN has licensed the rights to manufacture the products and has also acquired the rights to advertise through direct-to-consumer media including television, print and Internet.

Yahoo Health Launches…
Psoriasis Health Center, a new educational resource to help educate the public and dispel myths about psoriasis. The launch coincided with National Psoriasis Awareness Month in August, recognized by the National Psoriasis Foundation. The Psoriasis Health Center (http://health.yahoo.com/health/
centers/psoriasis) is sponsored by Genentech, which discovers, develops, manufactures and commercializes biotherapeutics. At this site, patients can access information about treatment, recent research, physicians in their area, support groups and news articles on psoriasis.

Physician’s Choice of Arizona…
CEO Margaret Ancira was honored recently for aiding foreign physicians seeking to further their education. The Foundation for International Dermatologic Education, an educational arm of the American Academy of Dermatology, recognized this contribution at the Annual Meeting in March. Ms. Ancira helped provide travel grants for two dermatologists from Mexico who would have otherwise not been able to attend the continuing education courses.

U.S. Patent and Trademark Office…
has issued a new patent for the use of betulinic acid, also known as ALS-357, and its derivatives as a method for treating cancer. The patent was granted to the University of Illinois at Chicago, which is collaborating with Advanced Life Sciences in Woodridge, IL, to advance the drug and its derivatives as anti-cancer agents. The lead ALS-357 compound has demonstrated efficacy in animal models to treat and prevent malignant melanoma.

Research Shorts...

Treating Scars
A recent article in The Journal of Cosmetic & Laser Therapy found that the DioLite 532 nm laser is effective in treating mature scars. The authors used the DioLite 532 to treat the vascular and pigmented components of 23 mature scars in 22 patients. Overall scar clearance averaged 81% after 2.4 treatments. Facial scars showed the best clearance, averaging 94% after two treatments. The authors concluded that this laser is effective for improving the cosmetic appearance of mature scars and may be used as first-line treatment for hyperpigmented and hypervascular mature scars.
Source: The Journal of Cosmetic & Laser Therapy, July 2003

Atopic Dermatitis
Results of a randomized, double-blind trial published in a recent issue of the British Medical Journal found that twice-weekly fluticasone (Cutivate) added to emollient during maintenance phase reduced relapses in atopic dermatitis. The study used 39 dermatology clinics in six countries and 376 patients aged 12 to 65 years, with moderate to severe eczema. Patients applied fluticasone propionate cream or ointment once or twice a day for 4 weeks for stabilization. Then, 295 patients maintained by applying fluticasone or emollients alone twice per week for up to 16 weeks. All continued to apply emollient with bath oil daily as needed. After 16 weeks, 133 patients still had their eczema in control (87 using fluticasone and 46 using emollient). Median time to relapse was 6 weeks for emollient and more than 16 weeks for fluticasone. All had comparable rates of adverse events.
Source: British Medical Journal, June 2003

New Insights into Skin Structure
Results of a study in the Journal of Cell Science offer insights into the skin’s structure that may help researchers understand how normal skin maintains its integrity and protects us from environmental hazards. The research focused on proteins called the plakins and how they maintain skin cells’ structure. Plakins contribute to several inherited and autoimmune diseases affecting skin, nerves, and cardiac and skeletal muscle. This research studied two plakins expressed in the skin, periplakin and envoplakin. Researchers used genetically modified cells and created mutations that changed part of the structure of periplakin and envoplakin to determine which parts were essential for normal function. Results showed that periplakin’s C terminal is essential for its association with keratin and vimentin filaments, proteins in cytoskeleton that help maintain normal skin structure. Removing certain amino acids in periplakin’s C terminal disrupts the association with keratin and vimentin filaments. Further analysis showed that the periplakin C-terminus might stabilize the interaction between the envoplakin C-terminus with intermediate filaments. Results need to be confirmed in intact skin.
Source: Journal of Cell Science, May 2003

Seeking Treatment
Many teenagers may be going without medical help from dermatologists because parents aren’t seeking treatment from doctors. A May 2003 survey by Harris Interactive for the American Counseling Association shows that despite knowing they were self-conscious about their own acne as teens and knowing it impacts their childrens’ self esteem, only 1/3 of the parents surveyed are taking their children for medical treatment.
Survey data, supported by an unrestricted educational grant from Dermik Laboratories, was based on 514 completed online interviews among parents of children ages 13 to 19.
In an effort to help bridge any “communications gap” between parents and teens, Christopher Knight, who played Peter Brady on “The Brady Bunch” has been the official celebrity spokesperson for the ACA’s “Healthy Skin, Healthy Outlook” campaign for the past 3 years. Knight is involved to help get the word out to parents and teenagers that acne is a treatable condition that shouldn’t be ignored.

FDA Approvals and News

New Wound Dressing

Aquacel Ag, an antimicrobial wound dressing, was cleared by the FDA for marketing in the United States. The dressing is indicated for acute and chronic wounds, including partial-thickness burns, surgical wounds, diabetic foot, leg and pressure ulcers. Manufactured by ConvaTec, a Bristol-Myers Squibb Company, the dressing is the only anti-microbial wound dressing that offers a gelling mechanism, which contributes to a moist healing environment.

The dressing is made of sodium carboxymethylcellulose with ionic silver 1.2%, which is effective in killing a broad spectrum of pathogens, including Pseudomonas aeruginosa and Staphylococcus aureus, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Entero-coccus (VRE), and other wound pathogens.

In addition, the Aquacel Ag dressing contains a proprietary Hydrofiber technology, which enables the dressing to absorb up to 20 times its weight in fluid, and is designed to vertically wick away bacteria-containing fluid.

Pediatric Drug Testing

According to a new study in the Journal of the American Medical Association, only about one-third of drugs used to treat children have undergone adequate study in this patient group and have appropriate product label information.

The study was conducted to evaluate the effectiveness of an FDA incentive program that encourages pediatric testing of drugs, according to the Associated Press.
The incentive program, which was mandated in 1997 and reauthorized last year, enables companies that conduct pediatric studies on a drug to enjoy 6 more months of market exclusivity before the FDA approves generic equivalents of the drug.

Some positive findings of studies influenced by the incentive program include the discovery that some steroid creams used for diaper rashes and athlete’s foot may dangerously suppress the stress response in some children.

According to the JAMA report, the following was found:
— Between July 1998 and April 1, 2002, FDA had requested studies on 242 adult drugs commonly used to treat children. Of that number, 53 of the drugs were granted exclusivity for agreeing to conduct pediatric studies.
— By January of 2003, 49 drugs had added pediatric information to their product labels.
— By August of 2003, the number of products studied in children has climbed to 88, with 58 including updated labeling information.

Presently, legislation has been approved in the Senate and awaiting action in the House that would require drug companies to perform pediatric studies on medications for adults that are also typically used in children.

Raptiva Set for Review

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee had set a review date of early September for Genentech’s and Xoma’s biologic treatment for psoriasis, efalizumab (Raptiva). The drug, which targets patients who have moderate-to-severe plaque psoriasis, has been studied in more than 2,700 patients — the largest database of patients treated with a targeted biologic therapy for psoriasis, according to Genentech.

The BLA for Raptiva, which works by blocking the activation of T-cells that cause psoriasis without destroying them, was filed in December 2002.

Recall of Device that Detects Certain STDs

The ProbeTec ET Instrument was recalled by the FDA Center for Devices and Radiological Health. This in vitro diagnostic medical device is used to detect chlamydia and gonnorhea in both asymptomatic and symptomatic patients. The device is being recalled because a component of it was incorrectly installed and has caused false positive and false negative results. You can research more information about the recall notice by visiting the Web site www.fda.gov/medwatch/SAFETY/2003/safety03.htm#ProbeTec.

Labeling Changes to Acitretin (Soriatane)

The FDA Center for Drug Evaluation and Research issued its latest approved safety labeling changes recently, and among them include changes to several sections of Soriatane’s labeling. Be on the lookout for changes to the following sections of this drug’s labeling:

— Contraindications: Pregnancy Category X
— Boxed Contraindications and Warnings: Important information for men taking Soriatane
— Warnings: New information for prescribers regarding drug interactions
— Precautions: Geriatric use information
— Adverse Reactions
— Patient Agreement/Informed Con-sent for Female Patients
— Medication Guide
— Pregnancy Prevention Program Booklet.