It doesn't seem possible to post a pdf file here, so I am pasting the whole article.  It is quite long.

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Editorial

Journal of Investigative Dermatology (2013) 133, 583–585. doi:10.1038/jid.2012.360

The Ever-Evolving Landscape for Detection of Early Melanoma: Challenges and Promises

It doesn't seem possible to post a pdf file here, so I am pasting the whole article.  It is quite long.

—————————————————————————————————————————–

Editorial

Journal of Investigative Dermatology (2013) 133, 583–585. doi:10.1038/jid.2012.360

The Ever-Evolving Landscape for Detection of Early Melanoma: Challenges and Promises

Alan C Geller¹ and Allan C Halpern¹

Over the past three decades, much progress has been made in reducing deaths from cancers for which preventive strategies are available. Most strikingly, mortality rates have dropped between 20 and 50% for cancers of the breast, cervix, colon, lung, and prostate (SEER, 2012). Conversely, the death rate from melanoma has remained remarkably stubborn, the product of two divergent trends: rising melanoma mortality rates for Americans aged 60 years and above, especially among men, countered by falling melanoma mortality rates for nearly all age groups below 60 years (SEER, 2012). Melanoma was once a rare disease, with fewer than 2 cases per 100,000 in the 1950s, compared with more than 25 cases per 100,000 today (SEER, 2012). It is now the fifth most common cancer in US men and the cause of more than 9,000 American deaths each year (SEER, 2012).

Until recently, doctors have had little to offer to improve the survival of patients with metastatic melanoma. Likewise, the medical and public health communities have had insufficient evidence supporting the value of melanoma screening to persuade the US Preventive Service Task Force (USPSTF) of its merit. However, in the past watershed year, major developments have impacted both ends of the melanoma disease spectrum. For advanced melanoma, the approval of two new drugs—Yervoy and Zelboraf—has ushered in a new era in therapy (Sondak and Flaherty, 2011; Luke and Hodi, 2012). These drugs, which attack specific targets in appropriately selected tumors on the one hand while bolstering the immune response to melanoma on the other, not only are helping many patients but are also paving the way for even more effective combination therapies. On the prevention end, a public health experiment in Germany has breathed new life into the prospects for population-based melanoma screening (Katalinic et al., 2012). In Schleswig-Holstein (SH), the northernmost German state (population 2.8 million), melanoma mortality dropped 40% after a population-wide screening program in which an estimated 20% of individuals aged 20 years and older were screened. By comparison, melanoma mortality in nearby Denmark and the rest of Germany changed little during the same period (2000–2009) (Katalinic et al., 2012).

The success of the SH experiment can be attributed to the collective commitment of many, including the more than 1,000 dermatologists, general practitioners, and other physicians who participated in an eight-hour training program, as well as the more than 360,000 German residents who underwent screening. Involvement by the German government, federal insurers, and the local media was also critical. In addition, the charismatic and untiring leadership of the Arbeitsgemeinschaft Dermatologische Prävention, or “Working Group on Dermatological Prevention,“ was paramount in its success. The extension of the SH screening program to the remainder of Germany bears a striking resemblance to organized efforts in Scandinavian countries to introduce the Pap smear to a largely unscreened populace in the 1960s. Although the impact of melanoma screening in Germany may fail to mirror the precipitous 90% drop in cervical cancer mortality (Sigurdsson, 1999) witnessed in Scandinavia over the first 20 years of screening, if the SH experience is replicated across the country, it will be a ringing endorsement of the value of screening. In comparing the German melanoma experience with the Scandinavian cervical cancer experience, it is important to note that a sustained, concerted effort spearheaded by local and community-wide public health officials was required to achieve a >85% rate of screening of women aged 18 years and older in many parts of Scandinavia.

In light of the size of the impact observed in SH, we can anticipate the probability of a positive outcome for the nationwide experiment in Germany. Analogous to cervical cancer screening, given the relatively low costs and morbidity associated with melanoma screening, a strong trend in reduced mortality in response to the screening should translate into a mandate for population-based screening in the United States. It is therefore imperative that we begin to address the major challenges to melanoma screening in the United States.

First, we must commit to crafting a national plan to reduce melanoma deaths to well below the rates we see today. Critical participants are already in place: more than 750,000 melanoma survivors and their estimated 2 million first-degree family members; organizations such as the American Academy of Dermatology, the American Cancer Society, and the National Council of Skin Cancer Prevention; foundations; and the National Cancer Institute and Centers for Disease Control and Prevention.

The screening effort in Germany was fueled by a creative outreach campaign coupled with nearly universal physician training and led by unprecedented funding mechanisms. The many unanswered questions for the dissemination of such a program in the United States include who will pay, who will do the screening, and whether visual examinations should be bolstered by new technologies.

Central to the plan are three long-term imperatives: (i) teach the basic, integrated skin examination to previously untrained physicians and physician extenders; (ii) screen high-risk unscreened individuals; and (iii) conduct the requisite research to quantify the risks and benefits of screening and inform screening strategies. Although persons of low socioeconomic status and white middle-aged and older men are at increased risk of fatal melanoma, they are the least likely to report having been screened. In fact, more than 50% of melanoma deaths are in white men 50 years of age and older (SEER, 2012), but only 16% have ever been screened (Coups et al., 2010). Lessons can be learned from our colleagues, policy makers, and women’s groups who have spearheaded efforts resulting in 80% of US women 50 years of age and older undergoing mammographic screening. Although most melanoma patients have seen their primary-care physician in the year before diagnosis, they often report that they were not screened for melanoma (Geller et al., 1992).

Although melanoma “writes its message in the skin for all of us to see” (Davis, 1988), formal training in melanoma detection is clearly needed. By extracting the best parts of the eight-hour mandatory continuing medical education course for German physicians and combining it with the US INFORMED (Shaikh et al., 2012) Web-based curriculum, we can produce a masterful and engaging Web-based skin cancer teaching program that can be rigorously tested for internists, nurse practitioners, and physician assistants. A recent editorial in the New England Journal of Medicine (Prober and Heath, 2012) called for similar teaching techniques for medical students. Bold and innovative successes from the Khan Academy and its online library resource of more than 3,300 educational videos show promise for teaching and disseminating new information. And the use of such technology as teledermatology, total-body photography, and digital dermoscopy, which improve sensitivity while achieving low benign:malignant biopsy rates, must be incorporated into new teaching.

Second, incorporating new policy initiatives is paramount. The USPSTF recently gave a B-level recommendation for behavioral counseling to prevent skin cancer in patients 10 to 24 years old, an upgrade from the previous I rating (insufficient evidence) (Moyer, 2012). Such ratings indicate at least fair evidence that the service improves important health outcomes and concludes that benefits outweigh harms. Results from the well-executed German screening and educational program (albeit not a randomized study) should now be proactively shared with the USPSTF, which has previously argued that there is insufficient evidence to support the recommendation of population-based skin cancer screening (Wolff et al., 2009; US Preventive Services Task Force, 2009). In its most recent report on screening, the USPSTF noted that “no studies of the benefits of screening have compared a screened population with an unscreened population with respect to appropriate health outcomes” (US Preventive Services Task Force, 2009). If, indeed, the new evidence from the SH experiment in Germany results in revised guidelines, previously unforeseen possibilities emerge. For example, the skin cancer examination could be integrated into the wellness and preventive services prevention package due to go into effect as part of the Affordable Care Act by 2014. A significant economic barrier might also be lifted because patients would no longer be subject to deductibles for preventive services and physicians could seek reimbursement for the opportunistic examination.

Third, recognizing the limitations of the Germany experiment and the need for formal studies of melanoma screening, supporting and adopting new screening guidelines could pave the way for closed health-care systems and accountable-care organizations to consider implementation of formal studies of the risks, benefits, and cost-effectiveness of screening. Ideally, a randomized clinical trial of screening would be conducted. Unfortunately, however, the costs of such a study, especially in the current political and economic climate, may be prohibitive. For example, the cost of one proposed study—a five-year screening study involving 350,000 intervention and 700,000 control subjects and 12 years of follow-up—was estimated to be $70 million (Geller, 2009).

Prior to the launch of a national population-based screening trial, various components of the model should be pilot-tested in a stepped and coordinated fashion. Large numbers of physicians will need to be trained in the basic, integrated skin exam, and strategies to encourage participation must be developed. Physician extenders, such as physician assistants, nurses, nurse practitioners, and dermatology nurse practitioners, would also be important candidates for training as well as for participating in controlled studies evaluating online versus in-person training. The next steps would be to fine-tune patient recruitment and outreach strategies, test the new technologies, and devise a follow-up protocol. The resulting strategies could be piloted and demonstrated with those at highest risk for melanoma, such as first-degree relatives of melanoma patients and individuals with multiple atypical moles.

A study of potential harms of screening is key—although the USPSTF has expressed concern that false-positive results may lead to biopsies and unnecessary treatment, they have acknowledged that the evidence to back up this theory is limited (Wolff et al., 2009). Screening should be lodged within closed health-care systems that have experience in large screening trials and the demonstrated ability to follow up on all participants. They would also need to be capable of capturing melanoma thickness, mortality, and other relevant data. In addition, there may be the potential to seek funding for a Medicare demonstration project, possibly in a state with high melanoma mortality rates and physician networks lodged in underserved areas. Lessons can be learned on obtaining cost estimates for broad-scale public health efforts from the Assessing Cost-Effectiveness–Obesity group and its important contribution to obesity-prevention programs (Carter et al., 2009).

Finally, maximal resources from cancer-control organizations, including those in the United States, Germany, and the rest of Europe, should be devoted to optimizing data collection in these and comparator nations. The SH population-based screening program described above was a precursor to a large and expansive ongoing effort throughout Germany. To date (from 1 July 2008 through 1 July 2012), more than 75% of the general practitioners and dermatologists in Germany have completed the mandatory eight-hour training program, and more than 20 million screenings of individuals aged 35 years and older have been performed. Studies comparing melanoma mortality rates; evaluating tumor thickness in all cases diagnosed before, during, and after screening; and analyzing the costs of screening should be conducted in Germany and the results compared with those in neighboring nations.

In summary, in the United States, melanoma remains the only preventable cancer for which mortality rates are not dropping (SEER, 2012; Coups et al., 2010; Centers for Disease Control and Prevention, 2012). Nevertheless, population-wide screening rates remain low. As melanoma rates continue to rise and patient demand for screening accelerates, the current deficit in the dermatology workforce will become even more apparent. However, a confluence of new developments holds much promise. Web-based technology affords the potential to teach standardized skin cancer examinations to physicians, physician extenders, and high-risk patients in multiple settings. Digital dermoscopy offers clinicians new options for distinguishing between benign, atypical, and aggressive lesions. The Affordable Care Act has the promise of providing screenings to the majority of the US high-risk population that has yet to be screened. Finally, the results of the German screening program provide new and important evidence for the value and benefits of visual examination for melanoma.