What’s on Your Mind?

T he past year has yielded some notable clinical and practice management challenges for dermatologists. Here, we’ll take a look at some of the new and ongoing challenges that you face in practice and examine how these issues are shaping up to have an impact in 2005. How Will the Tougher Isotretinoin Prescribing Mandates Affect You? November was an eventful month for isotretinoin (Accutane, Amnesteem, Claravis, Sotret). First, the acne drug found itself dragged into the storm over Vioxx, Merck’s disgraced painkiller that has been linked to heart attacks and strokes. During Congressional hearings on the recalled pill, a U.S. Food and Drug Administration official, Dr. David Graham, testified that isotretinoin was among the drugs he’d like to see off the market. Less than a week later, though evidently not in response to Graham’s statement — which the agency publicly disowned — the FDA beefed up its already tight restrictions on isotretinoin. The new risk minimization action plan (RiskMAP) consolidates the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.) program and others like it that are now in place under one umbrella. It creates a single registry of patients who use isotretinoin, as well as the doctors who prescribe it and the pharmacists who dispense it. The new risk program, tentatively scheduled to go into effect in July 2005, requires women able to become pregnant to provide documentation of a negative pregnancy test before they receive isotretinoin. The FDA says the system will protect patient privacy with identification codes. The FDA claims the new system won’t “substantially” affect the ability of women to receive isotretinoin, according to an agency fact sheet. “It is not expected that it will be substantially more difficult for female patients capable of becoming pregnant to obtain isotretinoin under the strengthened RiskMAP than it would have been for such patients who, along with their prescribers, were fully compliant with the S.M.A.R.T. program. It is possible that some healthcare providers will choose not to participate in the strengthened RiskMAP.” In addition to the risk management systems, old and new, isotretinoin already carries “black box” warnings. With all these cautions, the drug is among the nation’s most closely regulated medication. That seems somewhat for a drug many patients and perhaps most dermatologists consider the closest thing to a miracle for the skin. Indeed, while the FDA has erected substantial barriers to taking isotretinoin, the chances it will be pulled from the market are vanishingly small, said Dr. James Leyden, Emeritus Professor of Dermatology at the University of Pennsylvania. “I would think that with the outcry from the specialty and from people who have taken this, it would not be difficult to get a million people to descend on Washington and say, ‘This drug changed my life.’” While Dr. Leyden thought the pregnancy risk can be managed with careful attention by patients and doctors — and critically, by conscientious office staff — he believed the best way to prevent pregnancies in women on isotretinoin is a step the FDA has so far been unwilling to consider seriously: Requiring women who might become pregnant to use an injectable contraceptive, such as Depo-Provera, if they take isotretinoin. Injectable contraceptives are nearly 100% effective at preventing ovulation, Dr. Leyden said. What’s more, his work and that of other researchers has shown that isotretinoin does not weaken their potency — an argument opponents of the idea have made over the years. “That has been the objection that has been raised, but studies have been done that show that is not the case,” he said. Fight Rages over Office Surgeries: How Will Dermatology Fare? A fierce turf battle is raging in the United States that has nothing to do with red or blue. The fight is over office-based surgeries, and who should be able to perform them. Dermatologists have been embroiled in the nasty mix, which has both money and professional reputations at stake, by taking a slice of the lucrative surgical market. The trouble mainly centers on liposuction using tumescent anesthesia. Plastic surgeons and anesthesiologists have cried foul, claiming that dermatologists and other physicians are unqualified to perform office-based procedures. These specialists argue that patients put themselves at unnecessary risk by seeking surgeries, particularly liposuction, from dermatologists. They have demanded that offices performing surgery be accredited by certifying bodies such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Indeed, there have been highly publicized deaths associated with liposuction, which surgeons perform under general anesthesia while dermatologists use local anesthesia. But evidence suggests that the risks aren’t equal for the two versions of the fat-removing operation. Dr. Brett Coldiron is a Cincinnati dermatologist who has studied the risks associated with office-based procedures. After analyzing 4 years of surgeries in Florida, Dr. Coldiron has come to this conclusion: “This whole issue about office accreditation and where [surgeries are] performed is nonsense,” he said. The heart of the matter, Dr. Coldiron believes, is that the greatest risk in office-based surgeries is when patients undergo general anesthesia. According to Florida’s data, nearly 60% of patient deaths, and 62% of patients transferred to hospitals resulted from procedures performed by board certified plastic surgeons. “They used M.D. anesthesiologists 85% of the time,” he said. What’s more, 7 of the 19 deaths and 31 of the 58 hospital transfers occurred during or shortly after cosmetic procedures that were not medically necessary, Dr. Coldiron explained. Nearly 4 in 10 deaths [37%], and 60% of transfers to hospitals occurred following operations performed in accredited offices. Ironically, Dr., Coldiron said, anesthesiologists and plastic surgeons have appealed to state medical boards to restrict office-based operations except those performed by plastic surgeons using general anesthesia. In fact, Dr. Coldiron said, firing a bow shot, the data suggest that patients would be better served by banning office-based surgeries under general anesthesia (preventing 49% of deaths) and those performed by plastic surgeons (preventing 55% of deaths). Dr. Coldiron and his colleagues are publishing 3 years of data in an upcoming issue of Dermatologic Surgery. He presented a 4-year picture at the ASDS meeting in San Diego earlier this year. Florida is the only state so far to mandate detailed and public event reporting. Dr. Coldiron fully supports the practice. “I think it’s great,” he said. “The truth will set us free.” Will a New Initiative Slow the Amount of Services Being Taken away from Dermatologists? There are now about 9,800 dermatologists in the United States, or roughly 3.5 per 100,000 Americans. Absent an increase in new physicians, that ratio is predicted to fall to 2.6 per 100,000 over the next 40 years as the population grows, and grows older, and veteran dermatologists leave practice. Faced with an excess demand for skin, hair and nail care, how can the specialty keep pace? The American Academy of Derma-tology hopes it has at least a partial solution to the problem. The Academy Dermatology Workforce Initiative (ADWI) announced in September 2004 that it will combine Academy and industry money to fund additional residency slots for skin specialists. The fund’s goal is to amass $6 million a year for 3 years, drawing donations from the Academy itself, along with corporations, foundations and individuals. The program will cover salaries and benefits for 10 dermatology residents in its first year, 2006, rising to as many as 30 a year in 3 years — enough to boost the total number of skin specialists being trained in the United States by roughly 10% during that time and by about 1% overall. After that, the success of the initiative will be re-evaluated. Dr. Alexa Boer Kimball, director of dermatology clinical trials at Massachusetts General Hospital and Brigham and Women’s Hospital, in Boston, said easing the physician shortage is critical to patients and the profession. “Clearly, increased wait times and decreased access [to care] have adverse effects on patients, but also on the specialty as a whole,” Dr. Kimball said. “We risk losing the practice of dermatology to other practitioners. Where there’s a demand, people tend to fill in the gaps.” While she has limited data on the subject, Dr. Kimball said there is evidence that other specialists, especially pediatricians, are taking on an increasing share of the work of skin experts. Of course, the ADWI isn’t likely to have any immediate impact on the private practice of dermatology. That will take a few years, when the new trainees will make their way onto the market. But Dr. Kimball predicted that the program will have a positive effect on academic dermatology as early as its first year. “Increasing, the number of residents in academic settings will increase the workforce. During their training they’re obviously helpful as well. In a sense you can look at them as physician extenders for academics.” The program could run into controversy, however. Relying on industry might taint the initiative in the eyes of some physicians and outside groups concerned about the growing link between doctors and corporations. Such arrangements are rare but not unheard of. Some rheumatology residents receive drug company sponsorship, Dr. Kimball said. Will Malpractice Insurance Woes Continue? Regardless of how much one thinks medical liability reform will affect health care costs for consumers, it’s clear that soaring insurance premiums do affect physicians. President George W. Bush has promised to make liability reform a legislative priority, and the republican-controlled Congress enthusiastically backs him. Some doctors could already be getting a break on malpractice rates. More than two-thirds of the nation’s liability insurers say the premiums they charge OB/GYNs, internists, and general surgeons plateaued in 2004, according to the latest Medical Liability Monitor. Similarly, an October study from Aon found evidence to suggest rate increases will slow next year. The consulting firm cited fewer malpractice claims against doctors and hospitals. On the other hand, the rate survey found that some insurance companies are continuing to levy 100% and greater increases on their premiums — and that overall rates are at record highs. Even though dermatology falls into what’s considered the “low-risk” category of doctors, rate hikes are still plentiful. Dermatologists in the Philadelphia area have reportedly had to cut back on services thanks to higher premiums, according to the American Academy of Dermatology Association. And the association said it has heard from dermatologists nationwide about escalating rates even when dermatologists have never had a claim filed against them. When dermatologists predominately treated acne and psoriasis with topical treatments, they faced relatively few lawsuits, said David J. Goldberg, M.D., J.D., a New York skin specialist. “Today, with an increase in the incidence of potentially deadly melanoma, an increase in cosmetic procedures being performed by dermatologists and an increased use of biologic agents [for conditions like psoriasis] there is a greater chance of lawsuits.” Dr. Goldberg, director of laser research and Mohs surgery at Mount Sinai School of Medicine, and an adjunct professor at Fordham Law School, offered this advice: “Dermatologists need to understand the thinking process of plaintiffs’ attorneys,” he said. “They must begin to understand the legal elements required to bring a successful cause of action against dermatologists. By understanding these and being certain to have appropriately signed informed consent from their patients, suits are less likely to be brought and therefore less likely to be lost by dermatologists.” Plastic Surgery On Television: Has it had an Impact on the practice of Cosmetic Dermatology? Between ABC’s “Extreme Makeover” and Fox’s “The Swan,” American TV viewers can be excused for believing that dermatologists and dermasurgeons are to skin problems what David Blaine is to street magic. Men and women on the two “reality” programs have undergone the gamut of cosmetic procedures, from nose jobs and body tucks to chemical peels and laser resurfacing. Audiences may feel they’ve gone through a mini-residency in skin medicine while witnessing miraculous results. Admittedly, the transformations on these two programs are dramatic and astonishing. But are they leaving patients with unrealistic expectations about what skin surgery can offer? The answer, according to one prominent skin specialist, is “no” — so far, at least. “These shows do too much too fast and actually scare [patients]. They see these shows as entertainment,” said Dr. Rhoda Narins, a New York dermasurgeon and President of the American Society for Dermatologic Surgery. “Most patients are very realistic. They want to look better, but natural. And of course, as soon as they look better they feel better and more vibrant. They want people to say, ‘You look great. You must have gone on vacation,’ but not actually realize they’ve done anything.” Dr. Narins, who has offices in Manhattan and Westchester County, said dermasurgeons have always encountered a small group of patients with unrealistically high hopes, and the two television shows haven’t changed that population. “They want a less-invasive technique but they expect it to do what the invasive procedure does. Someone with severe acne scarring cannot expect a non-ablative laser to do the same thing as a carbon dioxide laser,” she said. “However, if the non-ablative no down-time laser is the only thing you can fit into your life, you can get a good result and do the CO2 laser in the future.” Advances over the last decade or so in skincare technology have allowed doctors to take 10 to 15 years off a patient’s visible age without surgery or recovery time, Dr. Narins said. While shy of a total makeover network-style, the results can be nearly as impressive. And most patients come through the other end of the procedures “ecstatically happy,” she said. Yet Dr. Narins is always on guard for the occasional patients who are depressed when they seek treatment. “About 15% to 20% of people are on antidepressants, but it’s the untreated [patients] I’m most concerned about. Nothing you do for them really makes them happy.” Should the Biologics for Psoriasis Be First-Line Therapies, and Who Will Pay for Them? The market for biologic drugs to treat psoriasis is quickly becoming crowded. From Amevive and Raptiva to Enbrel and possibly others, the nearly 5 million American adults with the condition now can choose from a variety of these advanced therapies. But can they pay for them? Biologics are indeed expensive, running roughly $15,000 a year compared with the $7,000 or $8,000 for cyclosporine therapy, which includes frequent trips to the dermatologist. And the drugs are vastly more expensive than methotrexate, which is the cheapest option. Insurance reimbursement “is always an issue,” said Dr. Kenneth Gordon, a psoriasis specialist at Loyola University Medical Center, in Chicago. “As people use them more, it’s likely there will be more pushback from insurance companies.” On the other hand, Dr. Gordon said, “when you talk about overall insurance outlays for medication in the country, this is still a pretty small segment of it.” Patients across the country may notice more or less hesitation by insurers to cover biologic drugs depending on where they live. In Illinois, Dr. Gordon said, “if I can make a coherent argument to an insurance company, then I can generally get [the drug] covered.” But in California, New York, New Jersey and other states, doctors and patients may have a harder time securing payment for the medication. Prescribing biologics for psoriasis patients can therefore be a time-consuming task, one some doctors may be reluctant to undertake, although it often results in significant benefit for patients, Dr. Gordon said. Makers of biologics, including Biogen, Genentech and Immunex have taken pains to assist doctors with billing problems. On Raptiva’s Web site, for example, Genentech provides a detailed “reimbursement support service” that “navigates the reimbursement and distribution process and helps your patients obtain access to” the drug. Many doctors consider biologics last-option drugs, perhaps because they’re new, because they’re costly, or because they are mistakenly viewed as more difficult to administer than oral therapy. Dr. Gordon, however, believes they already play a role as front-line treatment in many, though not most, cases of psoriasis. “I think in many cases they should be front-line therapies,” Dr. Gordon said. “I’m not a big fan in doing ladders of therapies or in using algorithms” to determine who gets what when. Dr. Gordon estimates that 25% to 30% of his practice, which specializes in psoriasis referrals, are taking biologic drugs as a first systemic treatment. “Many come because their regular physician isn’t comfortable with systemic therapy.” One of The Most Pressing Issues Concerning Drug Prescribing Cost-cutting efforts affect all physicians, dermatologists included. One of the most popular ways these days to trim the bottom line on medical bills is the promotion of generic drugs over their brand-name counterpart, which are frequently more expensive. While every state allows pharmacists to substitute a generic for a brand-name in many cases, some states now require them to recommend generics to patients unless their doctor has specifically requested a brand-name alternative in writing on the prescription. In theory, generic drugs are chemically identical to the competition. The FDA states that “Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.” But do they perform the same in fact? Dr. James Del Rosso, a Las Vegas dermatologist and previously a practicing pharmacist, says that question is among the most pressing issue facing doctors as pressure mounts to use generics. Generic drug firms argue that their products are equivalent to brand-name drugs in every way except price. Dr. Del Rosso, how-ever, said doctors need to take a look at the studies proving those claims before they accept them. Too often, he said, such research doesn’t exist. What’s more, Dr. Del Rosso said, generic drugs are only proven to achieve the same levels in the body as brand-name medications — a standard that doesn’t guarantee equivalent performance. Then there’s the matter of how brand-name drug makers will react to a massive shift to generics. “If generics become the predominately prescribed medications, how will this affect the reality of what pharmaceutical companies can bring to the market in the future?” said Dr. Del Rosso, Clinical Assistant Professor of Dermatology at the University of Nevada School of Medicine. “How is the industry going to respond if it can’t recoup the investments in its research, and generic drug manufacturers can use the scientific developments of others but not develop anything on their own?”