News and Trends: News And Trends - Break for Residents Will the Limited Hours Prove Beneficial? Beginning in July 2003, residents will have a bit more time on their hands when standards enforcing an 80-hour per week schedule take effect — if all goes as planned, that is. Amidst an atmosphere of growing concern for patient safety, the Accreditation Council for Graduate Medical Education (ACGME) announced new standards on resident duty hours last month. Also, legislation to decrease residents’ hours was introduced by Rep. John Conyers, Jr. (D-Mich.). “There is increasing evidence that the long hours residents work lead to medical errors, and there is little doubt about the profound detrimental effect on their personal lives,” commented Alexa Boer Kimball, M.D., M.P.H., chair of the American Academy of Dermatology’s Workforce Taskforce. “Reform is a critical issue,” she added. Highlights of the standards are as follows: • Residents’ hours will be limited to 80 hours per week averaged over 4 weeks. An institution’s graduate medical education committee may increase the hours by 10% under special circumstances. • Residents will get at least 24 hours off from caring for patients in each 7-day period. • On-call will be limited to at most every third night. • Residents won’t be scheduled for more than 24 hours of continuous duty, with up to 6 hours additional if deemed necessary to provide additional care for existing patients — but without accepting any new patients after 24 hours. • Residents will get a minimum rest time of 10 hours between each segment of duty. • When residents provide on-call care at the hospital, this must be counted toward the 80-hour limit. But will these standards be enough, and will they be enforceable? “Concerns about the specific ACGME guidelines include whether they’ll have enough of an effect since they allow averaging of time across a given month,” explained Dr. Kimball. “Furthermore, there’s the question of how they’ll be enforced,” she added. “A recent New York state investigation, where similar rules are already in effect, revealed that two-thirds of the hospitals were in violation of the state law.“There are also substantial economic ramifications that are important. Many academic medical centers already have financial problems, and these rules may require increased staffing that they can’t afford. Dermatology Drugs Snapshot of a growing market. Over the next 4 years, the worldwide market for prescription dermatological drugs is estimated to grow by $3 billion to reach $10.6 billion by 2006. Overall, this market has grown at a rate of 9% from 1996 to 2001, according to Kalorama Information, an independent market research firm that is a division of MarketResearch.com. During these years, the biggest market drivers were prescription antiacne, hair loss and hair removal drugs and antifungal treatments. Here’s a closer look at the largest growth areas: Antiacne. Between 1996 and 2001, the antiacne market grew by 16.5% and is estimated to grow by another nearly 9% by 2006. Here’s a look at some details: • 1996 — the market was $972 million. • 2001 — the market increased to $2 billion. • 2006 — Kalorama predicts increased growth to reach $3.3 billion. Retinoids represented the bulk of growth during 1996 and 2001 with the introduction of (Avita), adapalene (Differin) and tazarotene (Tazorac). By 2001, retinoids grabbed $1.5 billion of the overall $2 billion antiacne market with antibiotics taking nearly the rest of the market share with revenues of $457 million. Hair loss and hair removal. In the United States, this market grew by 55% between 1996 and 2001 and is expected to grow another 10% by 2006. A look at manufacturer revenues for the hair loss and hair removal market since 1996 reveals: • 1996 — this market was $32.7 million • 2001 — it had jumped to $173 million • 2006 — estimated growth is expected to reach nearly $281 million. This explosive growth was due in large part to drugs such as finasteride (Propecia), which captured 71% of the prescription market in 2001. Bristol-Myers Squibb’s hair removal drug, eflornithine HCl (Vaniqa), came in second with market share, and in third place was Pharmacia’s minoxidil (Rogaine). Antifungal. Between 1996 and 2001, the antifungal market grew nearly 11% and is estimated to grow another 8% by 2006. Here’s a look at the details: • 1996 — manufacturer revenue was $1.3 million. • 2001 — revenues increased to $2.1 million. • 2006 — the market could climb to $3.2 million. Between 1996 and 2001, the antifungal market had moderate growth due to the approvals of itraconazole (Sporanox) and terbinafine (Lamisil) in addition to Novartis’s (Lamisil’s manufacturer) aggressive consumer ad campaign. E&M Guidelines No More Panel votes to recommend eliminating them. A Department of Health and Human Services (HHS) task force voted 20 to 1 to recommend eliminating Medicare’s evaluation and management codes. Senior HHS officials now must decide if the agency has the authority to accept the proposal and if it is willing to do so. The decision to recommend elimination came after the HHS’s May meeting. The government has spent almost 10 years trying to make these guidelines usable with little success, which is why the HHS task force wants to do away with them. The E&M guidelines put a paperwork burden on physicians, taking their time away from patients. The task force discussed that one of the biggest problems with the E&M guidelines is that they emphasize a doctor’s clerical skills over his or her ability to make appropriate medical decisions about what’s best for the patient. The American Medical Association (AMA) supports the task force’s decision and agrees that the guidelines could have been much simpler. Summer Care Tips Prepare your patients for the sun. Sun damage can effect your patients anywhere on their bodies. It’s important to remind them about overlooked dangers, such as exposure to the eyes and mouth.You may already warn your younger patients and their parents about wearing sunscreen whenever they’re outdoors, but what about protecting their eyes? Exposing children’s eyes to the sun can cause vision damage later in life, according to recent studies. The most recent data out from the Vision Council of America reports that 49.5% of parents revealed their children “never” or “seldom” wear sunglasses with 100% UV protection. Most parents in the survey (91%) agreed it’s important for children to use sunscreen — children were twice as likely to wear sunscreen versus sunglasses. While 82% of parents reported it was important for children to wear sunglasses with 100% UV protection, the research showed that many parents aren’t enforcing their beliefs. Susan Taub, M.D., F.A.C.S., of the Taub Eye Clinic in Chicago emphasizes that “sunglasses are not a toy or novelty item . . . and insisting on sunglasses with 100% UV protection, you can best protect your children’s eyes from the sun.” Unprotected eyes can lead to macular degeneration and an increased risk for cataracts later in life. If patients want to know more about eye health, they can visit www.checkyearly.com. MORE SUN PROTECTION BENEFITS The sun can do more than cause UV damage. For patients who are prone to cold sores when exposed to the sun, preventing them before they start is the best defense. Triggered by sun exposure, cold sores result from sunburn on the lip, but help has arrived. The cold sore medication, Abreva is the only non-prescription cold sore medicine approved by the FDA to shorten healing time. In addition to expediting the healing process with Abreva, dermatologist, Dr. Debra Jaliman, from the Mount Sinai School of Medicine in New York, offers some summer skin tips for your patients: - Stay out of the sun between 10 a.m. and 4 p.m., and apply a sunscreen with SPF 15 or higher. - Moisturize lips with an SPF of 15 or greater. Avoid lip licking because saliva increases the risk of sunburn. - Apply Abreva when the first signs of a cold sore appear such as tingling, redness, blistering and itching. - Apply moisturizer immediately after showering or bathing, while the skin is still wet. - Avoid hot temperatures when showering or bathing — heat can lead to more drying and scalding of skin. Early Melanoma Protection Two new breakthroughs show promise. When patients are diagnosed with melanoma, it can often prove fatal because of its typical late-stage detection. A new device and a new study recently out, are providing doctors and patients with renewed hope for more aggressive treatments against this deadly cancer. A recent discovery, published in the online version of the journal, Nature, has found a spontaneous change in a certain gene among 70% of melanoma cases. The discovery occurred at the Cancer Genome Project in Cambridge, England and is being toted by genetics experts as the biggest breakthrough for melanoma research in years. The mutated gene, called B-RAF, remains “on” all the time rather than switching between on and off. The malfunctioning gene keeps the cells multiplying unchecked, eventually leading to cancer. In 70% of the melanoma cases, the code letter of the B-RAF gene were shuffled, leading researchers to believe a new melanoma drug designed to switch “off” the gene in cells with a mutated version is promising. Also, a new imaging device, manufactured in Australia, claims to detect melanomas at a much earlier stage. The Solarscan is an “imaging gun” that, when placed on patient’s skin, detects melanoma instantly. The device stores the images of the skin spots for future patient check-ups. According to Australia’s Science Minister Peter McGauran, “Solarscan will ensure more accurate melanoma diagnosis so that fewer people have to undergo an unnecessary operation.” The device was developed by Commonwealth Scientific and Industrial Research Organization (CSIRO), the Australian government scientific body and by the Australian company, Polartechnics. Fast Facts - As the Aging World Turns Fact: Today, on a global scale, 1 person in 10 is age 60 or older around the world. By 2050, that number will climb to every 1 in 5 persons. Fact: In 2050, for the first time in history, the number of people age 60 and older will outnumber the age group of 0 to14. Fact: By 2050, the age group encompassing the oldest — people age 80 and older — will increase as well. Presently, 12% of people age 60 and older are age 80 and above. By 2050, that age group will jump to 19%. Fact: By 2050, an estimated 3.2 million people around the world will be older than 100. – Source: The United Nations. In Brief... Connetics Earns Licensing Rights For Acne Gel…Connetics Corp. will now license the acne gel, Velac, a combination of 1% clindamycin and 0.025% tretinoin, from the Tokyo-based Yamanouchi Europe B.V. Connetics has exclusive rights to commercialize and develop the gel in the United States and Canada. Based on the outcome of a pre-IND meeting with the FDA, clinical trials could begin in early 2003. Cell Robotics and Sandstone Medical Technologies Enter Agreement on a Medical Laser… Sandstone Medical Technologies announced in mid-May that it’s reached an agreement with Cell Robotics to develop a proprietary medical laser for skin rejuvenation, which is based on Cell Robotics core laser technology. Cell Robotics will maintain manufacturing rights as well as the right to sell the product in international markets while Sandstone will market and sell the product in North America. Hair Weight Improved More than Hair Count with Finasteride…In a recent study published in the Journal of the American Academy of Dermatology, the type II 5-alpha-reductase inhibitor used to treat alopecia, finasteride, improved hair growth and thickness more than it improved hair count. The study researched finasteride’s effect on the hair weight of 66 men whoreceived 1 mg of the drug or placebo daily for 48 weeks. Researchers noted finasteride was well-tolerated and changes in hair weight indicated finasteride improves hair growth rate and/or the thickness of hairs. Long-Term Benefits of Genmab’s Psoriasis Drug … The Dutch biotech firm, Genmab, announced that some patients taking its psoriasis drug, HuMax-CD4, saw continued benefits 3 months after the phase II trial ended. Ten of the 64 patients treated with HuMax-CD4 saw results 12 weeks after the last treatment. Encouraged by the results, phase IIb trials will commence the second half of this year. Combination Therapies Reduce P. acnes… According to a recent study, a combination of two topical medications, an antibiotic and an antimicrobial, significantly reduced P.acnes bacteria levels by 90% after 24 hours. Findings from the journal, Cutis, tested 60 healthy subjects free of acne but with high levels of the P.acnes bacteria in a controlled trial. The results support growing evidence that combination therapies are more successful in treating acne than single agent therapies. NDA Submitted for New Antifungal Product from Fujisawa…A new drug application (NDA) has been submitted by Fujisawa by the FDA for their new antifungal product, Micafungin. Fujisawa seeks approval to use the drug alone or in combination with other systemic antifungal treatments. Micafungin belongs to the echinocandins, a new class of antifungal agents. Connetics To Begin Phase III Trial for Seborrheic Dermatitis…Connetics has announced plans to initiate a phase III clinical trial of the drug Extina, which is used to treat seborrheic dermatitis. The drug consists of 2% ketoconazole in a foam vehicle. Connetics plans to submit a New Drug Application to the FDA in 2003 based on a successful outcome of this trial. Teaming Up to Raise Awareness…The Skin Cancer Foundation and the U.S. Soccer Federation’s Under-19 Women’s National Team have formed a partnership to educate the public about the dangers of skin cancer. The U-19’s will spread their message of sun safety through the distribution of educational materials at clinics, schools and in the media. News from Stiefel… Stiefel recently announced it has promoted Brad Hershman to manager of sales operations, Devin Buckley to vice president and general counsel and Matt Pattullo to vice president, human resources and risk management/corporate secretary. Nail Disease Awareness Most people don’t know the signs. Despite recent consumer ad campaigns to make the general public aware of nail disease, it seems as if many people still aren’t aware of the signs and symptoms of infections that affect the nails. Photo courtesy of Dr. Aditya K. Gupta, and Elizabeth A. Cooper, B.E.SC., H.B.Sc. In a recent survey of 1,017 adults, less than half (48%) knew that unexpected physical changes in their nails could signify changes in their health status — such as cancer, diabetes, heart disease or kidney failure. Of those who responded to the survey (which was conducted by Roper Starch Audits and Surveys World-wide) who had experienced changes in the appearance of their nails, only 40% sought medical examination. Other findings of the survey, which was commissioned by Novartis Pharmaceuticals Corporation, the manufacturer of terbinafine HCl (Lamisil) tablets, include the following: • Women who were surveyed (54% of respondents) were more aware than men (42% of those surveyed) about the possible correlation between a change in the physical appearance of nails and serious health problems. • 54% of those surveyed be-lieved that people suffering from underlying diseases were more likely to have nail fungal infections. Rosacea Survey Possible link found between rosacea and other medical conditions. Rosacea patients may have more to worry about than just their skin disorder. A recent survey presented at the AAD in February and published in the National Rosacea Society’s Rosacea Review found that rosacea is not only one of the most common conditions found in patients visiting dermatologists, but may be linked to high blood pressure. Aditya Gupta, M.D., headed up the survey of 1,950 patients visiting a dermatology office. Dr. Gupta, associate professor in the department of medicine at the University of Toronto, found that rosacea was the most commonly diagnosed condition detected in 22% of patients, followed by acne vulgaris at 16% and actinic keratosis in 15% of patients. Other results included the following: • High blood pressure occurred in 21% of patients with rosacea, compared to 12% of those without rosacea. • Signs and symptoms of rosacea were mild in 74% of patients, with 29% of these patients recognizing their symptoms as rosacea. Dr. Gupta reported that these findings show there is a need for greater public education about rosacea since only 29% reported knowing their symptoms were from rosacea. The National Rosacea Society conducted another study of 1,077 rosacea patients and found that 77% said they had also been diagnosed with another skin condition. Results from this survey showed that in addition to having rosacea: • 28% reported having acne vulgaris • 27% said they have non-melanoma skin cancer • 24% have warts • 23% have seborrheic dermatitis. • 16% have seborrheic keratosis • 14% have actinic keratosis • 18% have contact dermatitis • 15% have psoriasis. Overall, 48% of participants reported being treated for another skin condition besides rosacea and 69% of these patients said the second condition hadn’t aggravated their rosacea. Ninety-five percent said their other condition was under control and 87% said their rosacea was under control. Skin & Aging - ISSN: 1096-0120 - Volume 10 - Issue 07 - July 2002 - Pages: 10 - 27