Guest guest Posted May 25, 2002 Report Share Posted May 25, 2002 With all this discussion about the testing methods for Cutanix, I thought I'd add the article below written by the derm who was in charge of the clinical studies. I'd like to try a sample of Cutanix myself and am hoping that Dr. Pilcher will make those available to interested people in our group. Take care, Matija December 1, 2001 By: Zoe Draelos, M.D. Dermatology Times Demanding excellence in OTC products Dermatologists responsible for raising bar in cosmetics, cosmeceuticals Dermatologists are a group of gifted individuals with the innate desire for excellence. It requires superior academic performance in college to achieve admission to medical school. Furthermore, it requires an outstanding medical school performance to obtain a dermatology residency position. There can be no doubt that dermatologists are accustomed to putting forth the extra effort necessary to rise to the top. I am always amazed at dermatology meetings to find out how special my colleagues are in many dimensions beyond medicine. The specialty we practice of dermatology is also based on excellence - excellence achieved through years of scientific research that has resulted in a better understanding of skin physiology and better pharmaceuticals to treat skin disease processes. There is perhaps more excellence in dermatology than other areas of medicine due to the exactness with which we can diagnose disease processes due to the easy accessibility of the skin for observation and biopsy. This is one of the key attributes that attracted me to dermatology. I vividly remember the frustration of trying to determine the etiology of obscure chest pain as a medical student. Was it cardiovascular? Was it musculoskeletal? Was it gastrointestinal? I do not find these same issues in dermatology. When a patient presents with a " terrible rash " and I cannot see anything present on the skin, I do not spend hours trying to determine whether a rash is or is not present. I simply take my visual findings into account and proceed to logically arrive at a diagnosis and treatment plan. The dermatologic armamentarium is also based on pharmaceuticals developed to standards of excellence. The topical pharmaceuticals that we use are no less scientifically formulated than oral medications and must adhere to the same standards as other FDA- approved oral medications. They must go through the same phases of testing in double blind placebo controlled studies to demonstrate efficacy. Dermatologists are accustomed to reading the scientific literature regarding a new topical pharmaceutical to determine whether it might provide a valuable benefit to patients. We review how well the active group performed as compared to the placebo group. We look at before and after clinical photographs, expert investigator assessments, noninvasive measurements, histology, etc. These standards are applied not only to our prescribing practices, but also to judgments made on the suitability of research manuscripts for publication. In short, we demand excellence in all information we receive regarding the use of topical pharmaceuticals developed for dermatology. Now, let's turn for a moment to the newly developed area of biologically active cosmetics and cosmeceuticals. I have noticed a tremendous increase in the number of exhibitors at our annual American Academy of Dermatology meeting detailing dermatologists on these over the counter products. As a matter of fact, I make a point of speaking to each of these exhibitors simply to keep abreast of new technology. However, in this arena I am dismayed by the lack of excellence. The sales representative who opens her discussion by telling me that I can greatly increase my practice revenue by buying their $5 bottle of cream and easily selling it for $20, without any discussion of product efficacy, is not respecting my position as a physician. The company president who tells me that I should sell his cream because his 15 best friends have all used the product and love what it has done to minimize their pores is wasting my time. The zealous gentlemen who wants to rub his cream on my hand to let me see how great it feels is missing the whole concept of product performance. I do not dispense in my office, but I do take a few minutes with each these people and explain to them that their communications with the dermatologist must take a more science-based approach, since we are not cosmetic counter salespeople. I think it is necessary for dermatologists to demand excellence from those companies who manufacture over-the-counter cosmetic products and cosmeceuticals. Some of these well-meaning companies do not know exactly what it takes to credential a product. We need to train them through our conversations. We must explain that scientific studies conducted in a blinded fashion with a parallel placebo group are the only way to document true cutaneous value. We must also insist that suitable sample sizes to achieve statistical significance are imperative. A loose study involving 20 personal acquaintances is insufficient. By demanding this information we will not only improve the quality of these products, but we will also maintain our professional excellence. This demand for scientific excellence must also extend beyond the Academy exhibit hall into our meeting rooms and our journals. Dermatologists or other scientists with corporate interests should not give presentations with obvious commercial ties based on mediocre data from poorly designed studies. I have attended several sessions where a dermatologist has given a presentation based on data obtained from a sample size of 16 patients and no placebo group with poor quality before and after photos. The dermatologist has clearly stated their proprietary interest in the product studied, but I still feel that the presenter should have been pulled from the podium with a long cane for even considering turning an educational meeting into a forum for commercial enterprise. These same standards, of course, extend to manuscripts accepted for publication in dermatologic journals. There is merit in presenting and publishing new ingredients and new formulations with documented efficacy that have been evaluated in a well-designed scientific study. All studies designed to assess the value of cosmetics and cosmeceuticals can and should meet the requirements for pharmaceutical studies. Who is going to raise the bar for excellence in cosmetic and cosmeceutical products? Dermatologists must raise the bar for excellence in cosmetic and cosmeceutical products. Why? Because we are the only people with the background knowledge and training to accomplish the job. Only we know what excellence in this realm truly means. There are many meritous products marketed by companies who have performed large scale testing which have demonstrated both safety and consumer benefits. Yet, I think that we can do better. We can demand better. We can ask salespersons for their published study results. We can tell fellow dermatologists to leave their poorly studied proprietary projects off the podium. We can reject articles that do not follow the scientific method. We can and should demand the excellence we expect in every other aspect of lives from cosmetic and cosmeceutical products. DT Quote Link to comment Share on other sites More sharing options...
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