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Just over one year ago, the United States FDA announced the approval of Evolence, a second-generation collagen filler derived from a porcine (pig) source. The product had a favorable safety profile and a steadily growing fan base among both patients and physicians due to a decreased incidence of post-procedure bruising and swelling. It has been used in other countries as far back as 2004.
Earlier this month, Ortho Dermatologics (a division of Johnson & Johnson) abruptly announced that Evolence will no longer be manufactured or marketed in the United States. Although no specific reasons were given by the company, I suspect the decision to discontinue the product was based on poor sales due to the slow economy. Last year, the Wall Street Journal quoted Johnson & Johnson consultant Kenneth Beer as saying, "they couldn't have picked a worse time [to enter the cosmetics market.]". In addition to a weak economy, competition in the cosmetics market is brutal, and I think it was difficult for a company that does not specialize in aesthetics to market and sell such a product effectively. Sales of Evolence were reportedly only $25 million over the past year, a figure far below expectations.
I have been a supporter of Evolence since the beginning and am disappointed to see it go. As a cosmetic dermatologist, I find it highly useful to have multiple filler options that can be tailored to individual patients. Evolence was a great product for patients who tend to metabolize hyaluronic acid products quickly, for those who cannot tolerate downtime, and for patients who bruise easily. It was also one of my favorite fillers for acne scars and other contour irregularities because it does not leave a bluish hue when placed superficially in the skin. My hope is that another company will decide to purchase the rights to Evolence and allow it to re-enter the U.S. market, perhaps under a different name. According to Israel's Globes Business Daily, Johnson & Johnson had purchased ColBar, the company which manufactures Evolence, for $159 million in late 2006 and was looking for a buyer in October for as little as $20 million.
In the meantime, Ortho Dermatologics will continue to provide support for Evolence regarding medical inquiries or reporting of adverse events.
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One of the easiest things a person can do to take 10 years off their appearance is to whiten their teeth. Teeth naturally come in a range of colors from white to yellow or grey, but as we get older, our teeth can become darkened or stained due to dietary habits. The biggest enemies to white teeth are acidic foods such as white wine, citrus fruits, and soda or foods that contain rich pigments such as coffee, tea, red wine, and dark berries. Acidic foods eat away at the surface enamel, allowing pigment and stains to penetrate even deeper into the tooth. Cigarette smoking is another major culprit.
To help keep your teeth pearly white, it can help to drink from a straw or avoid eating pigmented food for at least a half hour after acidic foods. Those with heavily pigmented teeth have several options for successful whitening. According to the FDA, the term “bleaching” is reserved for products or procedures which can whiten the teeth beyond their natural color. The term “whitening” is typically used for products (such as toothpastes) that can restore a tooth to its natural color by cleaning off stains or surface debris, but are not able to whiten teeth past their natural shade. As a marketing note, bleaching products often call themselves “whiteners” as this tends to sound more elegant than “tooth bleachers”, but the reverse is never true.
The most effective method of cosmetic tooth enhancement is long-term tooth bleaching under the supervision of a dentist. Qualified dentists can fit you with a set a trays that conform exactly to your dental anatomy. The trays are filled with a bleaching agent such as hydrogen peroxide or carbamide peroxide and worn overnight for two to three weeks. In-office or “power” bleaching is another option and involves a one-time intense bleaching treatment. The advantage to power bleaching is that it will lighten the teeth quickly for a specific event; however the results typically do not last as long as traditional whitening trays.
Over-the-counter tray systems can be purchased that contain whitening agents similar to those used in professional offices. The downside to these types of systems is that the trays are not individually fit to your anatomy, so there is more risk of sensitivity and irritation of the gum tissue. Other drugstore products include whitening strips or paint-on applicators which oxidize stains in a less intensive fashion. Whitening toothpastes typically contain either a low percentage of hydrogen peroxide to help oxidize stains or silica compounds and other abrasives that help brush away stains from the surface of the tooth.
Any form of tooth whitening may temporarily weaken tooth enamel, irritate gum tissue, and cause the teeth to become more sensitive. As we age, it can take longer to bleach the teeth and more maintenance can be required to keep them pearly white. Contact your dentist for further information or to see which method is best in your particular case.
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Dermal fillers are an increasingly popular form of non-invasive surgery to restore volume and improve the contour of the aging face. With most of the currently available fillers, the process is about the same. A physician injects the filler substance into an individual line or region of the face that needs plumping. After a little molding to smooth out any bumps, the patient is on their way.
In an exciting development, Kythera Biopharmaceuticals has recently initiated in-human proof-of-concept trials for a novel type of light-activated facial filler. The filler, preliminarily known as ATX-104, is a light-activated contouring agent that stems from a proprietary technology developed jointly by Kythera and Johns Hopkins University. ATX-104 is injected into the skin, shaped, and then an external light source is directed at the treatment area to induce photo-polymerization via free radical formation. Basically ATX-104 is composed of a conventional polymer material (similar to other hyaluronic acids) in combination with a cross-linkable polymer (polyethylene oxide or a derivative thereof) that is able to alter its mechanical properties after exposure to a visible light source. Thus, the injected filler is able form additional cross links to stabilize its composition into a semisolid gel while still maintaining pliability.
The theory is that the photofiller will last longer and hold its shape better than the current dermal fillers. This would be a particular plus for contouring applications such as cheek enhancement or chin augmentation. According to Kythera, pre-clinical testing has demonstrated improved persistence, maintenance of shape, and contourability in comparison to commercially available filler alone. Human trials are underway to evaluate the safety, tolerability, persistence and histological effects of ATX-104. If all goes well, ATX-104 could dramatically change the way we think about facial aesthetics and the melding of two technologies: non-invasive volume enhancement and laser/light therapy.
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Fall is always one of my favorite times of the year. The leaves are changing, the holidays are just around the corner and my local coffee shop is serving up Pumpkin Lattes. To get into the spirit, pumpkins can be used to make a homemade mask tailored to almost any skin type.
Pumpkins are naturally high in vitamins A, C, and zinc. Vitamin A helps to gently dissolve dead skin cells, vitamin C acts an anti-oxidant to protect the skin against free radical damage, and zinc helps boost the skin's healing properties. To make your own pumpkin face mask at home, whisk together ¼ cup of pureed fresh or canned pumpkin with one egg as a base. The egg helps tighten the skin and bind the mask together. From here, the next step is to customize your mask to your individual skin type. Those with dry or irritated skin can add a single serving pouch of plain oatmeal or ¼ teaspoon of heavy whipping cream. The oatmeal will help soothe the skin and the heavy whipping cream will add moisturizing lipids and exfoliating alpha-hydroxy acids. Those with oily skin can add ¼ teaspoon of apple cider which is a natural alpha-hydroxy acid and regulates the surface pH of the skin. Those with aging or sun-damaged skin can add ½ teaspoon of applesauce. Applesauce has anti-aging properties due to the natural fruit acids, pectin and tannin, which aid in skin turnover and rejuvenation. For added exfoliation, mix in ½ teaspoon of brown sugar or wheat germ as a scrub and gently massage your face in a circular motion just before it is time to remove the mask.
To apply, slather a light layer onto your face being careful to avoid the eye area. Leave the mixture on for 10 to 15 minutes, rinse off with warm water, and pat dry with a clean towel.
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October is National Breast Cancer Awareness Month. As breast cancer is the second leading cause of cancer death in women, patients should be aware of skin changes on or around the breast that may be a sign of breast cancer.
Breast cancer occurs when abnormal cells start to grow in one or both breasts and invade the surrounding tissue. Important things to look for include a reddish discoloration of the skin, retraction, dimpling or puckering, a change in size or shape of the breast, and crusting or discharge of the nipple. Unilateral changes are generally more suspicious than those involving both breasts, however a diagnostic workup should be done either way. Inflammatory breast cancer can present with redness, swelling, warmth, tenderness, and textural changes (puckering and firmness) involving a large part of the breast. An excellent collection of photos of the cutaneous signs of breast cancer can be viewed here.
Other conditions that can cause changes in the breast skin or nipples include eczema or atopic dermatitis, Paget's disease, contact dermatitis, mastitis, psoriasis, and seborrheic dermatitis to name a few. The most serious of these is Paget's disease which comprises 1-3% of all primary breast cancers. Paget's disease can mimic nipple eczema, but with a more persistent course, and may be accompanied by an invasive ductal carcinoma. Early diagnosis is key, so all patients should see their doctor immediately for evaluation at the first sign of changes.
A thorough work-up should be done in all patients who present with skin changes or nipple retraction. Your doctor will perform a complete breast examination looking for palpable masses or mammogram abnormalities and may perform additional studies such as ultrasound or tissue biopsies. It is important to record and tell your doctor the timing of the changes and how long they have been present. Congenital nipple retraction present since birth is generally insignificant, whereas recent nipple inversion is more serious, especially if it is only on one breast. Remember that roughly 1 in every 100 cases of breast cancer occurs in men. So any man who has a breast lump should also be evaluated.
The earlier that breast cancer is found, the more likely it is that the cancer can be curable. Routine screening for breast cancer is done using mammograms, clinical breast exams and self-breast exams. The U.S. Preventive Services Task Force (USPSTF) recommends screening mammography, with or without a clinical breast examination, every 1-2 years for women aged 40 and older. Anyone, male or female, regardless of age, with suspicious changes in the breast tissue should seek out evaluation from a qualified physician.
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Like watching a good movie, I laughed and I cried when I read a recent editorial published in a college newspaper by the manager of a tanning salon extolling the virtues of indoor tanning (http://breezejmu.org/2009/09/03/some-sunny-perspective/). I thought it deserved a professional response.
The tanning bed manager's main issue is a recent classification by the IARC (International Agency for Research on Cancer) classifying UV-emitting tanning devices as carcinogenic to humans. She calls the report an over-the-top, ridiculous suggestion that getting a suntan is in the same risk category as cigarettes, arsenic and plutonium. She then goes on to say that "not one single study exists anywhere in the world implicating tanning in a non-burning fashion as a significant risk factor for permanent skin damage."
The first thing to know is that the various classification groupings of the IARC simply relate to an evaluation of carcinogenic risk. UV-emitting tanning devices have been moved from Group 2A up to Group 1, meaning that the agent is unquestionably carginogenic to humans. Group 2A means the agent is probably carcinogenic to humans. Group 1 includes solar radiation, as sun exposure is a known cause of skin cancer including basal cell carcinoma, squamous cell carcinoma, and malignant melanoma. The classification system does not delineate as to types or grades of cancer produced. So tanning should be in the same category as smoking and arsenic. They are all carcinogenic. Period.
The decision was based on a comprehensive meta-analysis of roughly 20 epidemiological studies from peer-reviewed publications showing sufficient evidence that the risk of cutaneous melanoma is increased with tanning bed use. The term "sufficient evidence" is used because the studies, although valid in their conclusions, were not randomized, controlled trials, which is considered the gold standard in medical research. That would entail taking a group of people and exposing them to a harmful condition, knowing it is most likely harmful, just to prove the point. This has not been allowed since the World Medical Association developed the Declaration of Helsinki as a statement of ethical principles for all medical research, meaning that medical research has the duty to protect and promote the safety and health of all human subjects. Another example of this would be taking a cohort of pregnant women and having them take a drug that is thought to cause birth defects just to prove that it really does. It is just not going to happen; but it makes the conclusions drawn from evaluating the outcome of people who have been exposed to the agent no less valid.
The tanning bed manager writes "The sum of data do not substantively link indoor tanning equipment with an increased risk of melanoma. Indeed according to the IARC, 18 of 22 epidemiological studies ever conducted on this topic show no significant association." Her argument here is partially correct. Eighteen of the examined studies were not statistically significant on their own, but they trended toward an increase in certain types of skin cancer among tanning bed users. There are many reasons why individual studies may not be statistically significant and most are based on inherent limitations in performing retrospective analyses. This is the whole point to performing a comprehensive meta-analysis. By combining well-designed smaller studies into one large data pool, the power of the study is increased and the results may become more significant.
The IARC classification statement as well as the original meta-analysis states that based on 19 informative studies, "ever-use of sunbeds was positively associated with melanoma", detailing a 1.15 relative risk with a statistically significant 95% confidence interval. The IARC analysis also goes on to say that there is no consistent evidence of a dose-response relationship, meaning it doesn't matter if you tan in a tanning bed once in a while or on a regular basis, your risk for melanoma is increased by simply by using a tanning bed. The review confirms having first exposure to a tanning bed before the age of 35 can increase your risk of melanoma by as much as 75% (again, they cite a statistically significant 95% confidence interval here with a relative risk of 1.75). Incidentally, the report did say that they found no evidence to support a protective effect of the use of sunbeds against damage to the skin from subsequent sun exposure. So any of you who use a tanning bed to get a "base tan" for the summer or vacation, forget it.
The tanning bed manager then writes that the relationship between melanoma and sunlight cannot possibly be clear-cut because indoor office workers are more likely to get melanoma than those who work outdoors. The tanning bed manager is again partially correct in her statement, but the issue is much broader. Melanoma is a complex disease that often results from a combination of factors, rather than a single cause. These include genetics (i.e. fair skin, family history, the presence of dysplastic moles), environmental factors (i.e. history of sunburn, excessive sun exposure, exposure to carcinogens- including arsenic compounds), a weakened immune system (i.e. organ transplant patients, chronic leukemias or other cancers, medications), and lifestyle decisions (i.e. living in a sunny climate, tanning). She is also correct in stating that studies have shown office workers do have an elevated risk of melanoma compared to outdoor workers (Lee & Strickland 1980), however the increased risk is limited to professional and administrative type workers, not indoor workers as a whole. The discrepancy is thought to be tied to the professional workers having a higher socioecomonic status as they are the ones who work all year and earn enough money to go on a blowout beach vacation (only to come back with a sunburn). Studies also show outdoor workers do have an increased risk of melanoma, interestingly enough on the sun-exposed parts of their bodies versus the parts covered by protective clothing (Beral and Robinson 1981; Vagero et al. 1986).
Finally, the tanning bed manager calls the use of ultraviolet therapy by dermatology professionals to treat "psoriasis and other purely cosmetic disorders" hypocrisy. This statement just made me sad. I am guessing that the tanning bed manager does not have psoriasis or any friends or family members with severe psoriasis. If she did, she would never call it a purely cosmetic disorder. Psoriasis is a complex systemic disease that can have a significant negative impact on a patient's overall quality of life including their job and relationships. When dermatologists use light box therapy, they are generally treating patients with severe disease that is unresponsive or uncontrolled by other methods. The gold standard for light therapy is narrowband UVB, which does not pose significant risks for skin cancer in later life if used appropriately.
The bottom line is that sources of ultraviolet radiation, whether from the sun or a tanning bed, do emit ionizing radiation that causes specific mutations in the users DNA that can lead to skin cancers, not to mention wrinkled, saggy skin. The change in classification will probably not be enough to convince hard-core tanners to abandon their bronzing, but I suspect it may lead to government regulation such as banning under-18s from using sunbeds, required warnings to customers about the risks of sunbeds, and tighter supervision.
Further Reading:
- Beral V, Robinson N. The relationship of malignant melanoma, basal and squamous skin cancers to indoor and outdoor work. Br J Cancer. 44:886-91, 1981.
- El Ghissassi F, Baan R, Straif K, et al. on behalf of the WHO International Agency for Research on Cancer Monograph Working Group. A review of human carcinogens-Part D: radiation. The Lancet Oncology. 10:751-2, 2009.
- IARC Working Group, The association of use of sunbeds with cutaneous malignant melanoma and other skin cancers: a systematic review. Int J Cancer. 120:116-22, 2006.
- Lee JAH, Strickland D. Malignant melanoma: Social status and outdoor work. Br J Cancer. 41:757-63, 1980.
- Vagero D, Ringback G, Kiviranta H. Melanoma and other tumours of the skin among office, other indoor and outdoor workers in Sweden 1961-1979. Br J Cancer 53:507-12, 1986.
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Medical lasers have become increasingly common over the last two decades, mostly for cosmetic and dermatologic indications. As their use becomes more widespread, it is natural for scientists to develop novel ways to harness the technology. One of the most interesting uses is the possibility of laser technology to facilitate the delivery of medications through the skin.
Lasers are an ideal choice for drug delivery because the wavelength of the laser can be varied to target specific structures while preventing damage to the surrounding skin. In a process called laser microporation, mid-infrared fractional lasers are being used to target and superheat water in the skin, creating hundreds of tiny “pores” through which a drug could be delivered via an overlying patch. Drug dose is controlled by varying the total number of pores and pore properties such as size or depth. Medications ultimately make their way to the systemic blood stream by entry into the skin’s capillary network. The first such device called the Painless Laser Epidermal System (P.L.E.A.S.E.) by Pantec Biosolutions was recently approved for use in Europe.
Delivery of medications through the skin could be extremely useful because it would avoid problems of oral medications such as gastrointestinal upset and the first-pass effect of the liver, a phenomenon of drug metabolism where the concentration of a drug is reduced before it reaches the systemic circulation. Laser drug delivery would also reduce or eliminate the need for painful injectable medications, such as in hormone treatments for in-vitro fertilization. While it remains to be seen whether we will all have hand-held fractional lasers at home to take our medications at some point in the future, the idea is certainly intriguing.
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Just like the skin on the rest of our body, the earlobes change over time with aging and exposure to the sun. As collagen and elasticity decrease, the earlobes can become elongated and thin, with fine wrinkling on the surface. This can make it difficult to wear certain types of earrings such as small pearls or stones, which can fall downward due to lack of structural support around the post of the earring. The piercing hole may also become weak and stretched out or prone to tearing. Some scientists have even suggested you can tell the relative age of someone by the length of their earlobes.
In our cosmetic culture, earlobe rejuvenation is not uncommon and there are several options. If your earlobes are of a generally good size and shape but your earrings are starting to droop, a good option is to use an injectable filler such as Restylane, Juvederm, or Evolence to plump them up and add support. This can be done on your lunch hour, and you can continue to wear earrings immediately after the procedure. If your earlobes are overly elongated, you can have them surgically shortened with a simple outpatient procedure. This is normally done under local anesthesia with sutures left in place for about a week. Earlobes with excessive wrinkling can be improved with either fractional or ablative skin resurfacing. The good news is, you don't ever have to retire your favorite pair of earrings. And who doesn't want cute, perky, little earlobes?
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Dark circles in the undereye area is a common problem. What makes them so difficult to treat is that there are so many different problems that can cause them. No single solution works for all patients, so the key is to first figure out what is causing yours and then attacking the root of the problem.
There are three main components that can contribute to dark circles: volume, vascularity, and pigmentation. Volume issues are the most common and are due to normal aging and genetics. The fat pad in the cheek heads south while the fat in the lower eyelid is held in place by a thin sac. This causes a separation or groove between the two which is often referred to as a "tear trough deformity". The contour of this groove causes a shadow that gives the appearance of dark circles. The good thing about this type of dark circle is that it is easy to fix with a visit to a expert dermatologist or plastic surgeon that is skilled with injections in this area. A filler will plump up the area where the shadow occurs to smooth the contour, reduce or eliminate dark circles, and restore a youthful volume.
Prominent blood vessels on the lower eyelid or thin, transparent skin such that the red-purple color of the vasculature shows through is another cause of dark circles in the undereye area. This can be improved with a vascular laser that reduces the fine vessels close to the skin. Thin skin can be improved with eye creams containing low concentrations of glycolic acid or retinol.
Finally sometimes dark circles are just that...dark circles. The skin on the lower eyelid can hyperpigment from inflammation, dryness, irritation, allergies, sun exposure, or genetics. Lasers can be used to eliminate some types of pigment. Other types of pigment respond to chemical peels or topical lightening agents. Regardless, it is important to look at possible causes of the hyperpigmentation to help reduce the risk of recurrence after treatment.
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Researchers at the Wellman Center for Photomedicine in Boston, Massachusetts have developed a novel technique to replace sutures when closing wounds. The process harnesses laser light to "knit" layers of collagen together, thereby sealing together two edges of a wound--all without a needle and a thread.
The idea of laser bonded tissue is not new. Researchers have been trying to harness laser light to close wounds for years. The problem with these early trials has been that the reaction between lasers and tissue has a delicate balance. Too little heat and the wound would not heal. Too much heat and the tissue was damaged.
This new process has taken a different approach, using light, rather than heat or thermal energy, so there is no risk of tissue damage. Specifically, doctors paint a special light-activated dye called Rose Bengal along the edges of a wound they want to close. They then use a laser or light source to illuminate the area and help transfer electrons between the dye molecules and the collagen, causing the molecular chains of the collagen to chemically bond or link together nearly instantaneously.
The process, called nano-suturing, is a significant development for several reasons. Not only is it faster than sewing together a wound with sutures, there is likely to be less scarring and there may be a lower risk of wound infection. This is because it seals the opening completely such that external bacterial sources cannot penetrate. It also eliminates any irritation associated with having traditional sutures in place. Nano-suturing is expected to be used for skin closures, eye surgeries, and tendon, blood vessel and nerve repairs. The only problem is that the cost of the photochemical dye and laser equipment will make it much more expensive than traditional sutures. Only time will tell if the benefits will offset the cost.
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For a while now scientists have speculated that a low calorie diet may have advantages in halting the body's aging process. Studies in yeast, worms, flies and rats have all shown that cutting calories can extend the life span and possibly stave off age-related disease. This theory came one step closer to human application this month with the publication of long-term research on calorie restriction in monkeys in this month's issue of Science.
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Rhesus monkeys, left to right, Canto, 27, on a restricted diet, and Owen, 29, a control subject on an unrestricted diet, are pictured at the Wisconsin National Primate Research Center at the University of Wisconsin-Madison on May 28, 2009. The two are among the oldest surviving subjects in a pioneering long-term study of the links between diet and aging in Rhesus macaque monkeys, which have an average life span of about 27 years in captivity. This study, published in the journal Science, shows a nutritious, but reduced-calorie, diet blunts aging and delays the onset of such aged-related disorders as cancer, diabetes, cardiovascular disease and brain atrophy. Photo Courtesy: Jeff Miller/University of Wisconsin-Madison |
A group from the University of Wisconsin-Madison followed Rhesus monkeys over a span of 20 years. Half of the monkeys were allowed to go hog wild, eating as much as they wanted during the day, while the other half followed a restricted diet of 30% fewer calories than usual. Comparison between the two groups has found that 63% of the calorie-restricted monkeys were still alive versus only 45% of the free eating group. The big eaters also died of age-related causes like cardiovascular disease and cancer at three times the rate of the leaner monkeys and had a higher rate of brain matter deterioration.
While the full study is still in progress and data may not necessarily translate to humans, the evidence so far is compelling. The hypothesis is that cells are able to detect the level of nutrients available to the body, and that food restriction causes a gene-level response that tells the body to switch from breeding to tissue maintenance. But what fun is it to extend your lifespan if you can't spend your years eating cupcakes and Mexican food? It would obviously be extremely difficult for the average person to follow a strict, lifelong diet low in calories. The hope is that someday scientists will be able to develop a drug that would mimic the effects of caloric restriction, allowing us to have our cake and eat it too.
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Over the last two decades, there has been a marked increase in the number of people with low levels of Vitamin D. Data from the Third National Health and Nutrition Examination Survey revealed Americans had an average Vitamin D level of 30ng/ml from 1988 to 1994, with a decline to 24mg/ml from 2001 to 2004. The cause of this is not entirely known, but several factors are thought to play a role including decreased exposure to sunlight. Widespread education on the dangers of tanning and excessive ultraviolet radiation has increased our overall use of sunscreen and sun avoidance. While this has been successful at reducing skin cancers, it has also lowered our levels of Vitamin D since ultraviolet exposure triggers Vitamin D synthesis in the skin.
The classic symptom of a deficiency in Vitamin D is thin, brittle or misshapen bones. However Vitamin D plays a much larger role in our overall health status than simply maintaining serum calcium levels and bone growth. Vitamin D also plays a part in neuromuscular and immune function, reduction of inflammation, and prevention of a number of disorders including breast, prostate and possibly colon cancer, diabetes, glucose intolerance, high blood pressure, and dementia. Indeed, a recent meta-analysis found that vitamin D supplementation was associated with a reduction in overall mortality from any cause by a whopping 7%.
To find out if you have a deficiency of Vitamin D, ask your primary care physician to check your levels the next time you are having blood work done. New guidelines recommend adults have at least 30mg/ml for optimal health status. If you find yourself below this amount, ask your physician for guidelines on supplementation. The current recommended daily allowance of Vitamin D is 400 IU, however patients may need more than this to meet optimum levels. Taking too much Vitamin D can cause symptoms such as nausea, vomiting, constipation, weakness, weight loss, and, more seriously, high calcium levels, which can trigger kidney stones, mental status changes (confusion), and an irregular heart beat.
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In 2002, the United States FDA approved the first botulinum toxin for the cosmetic reduction of movement related facial wrinkles, Allergan’s Botox Cosmetic. Since then it has become one of the most popular minimally-invasive cosmetic treatments in the United States with more than 2.8 million procedures performed in 2008 alone.
On April 30, 2009, Dysport (Medicis Pharmaceutical Corp., Scottsdale, AZ) became the second botulinum toxin approved for cosmetic use. The product has been commercially available in Europe since the early 1990’s and is approved for aesthetic use in 27 countries. While worldwide experience is plentiful, physicians in the United States are eagerly putting the neurotoxin to the test.
So what’s the difference between the two products? Both have a central core molecule which serves as the “active” portion of the neurotoxin and both have the same mechanism of action. The main difference is that the two products have a different array of associated “non-active” proteins which are complexed around the active core. All in all, the two products will function nearly identically and have the same duration of action, however there may be some subtle advantages to Dysport.
The first is that Dysport has a lower protein load than Botox. This means that the body should form fewer antibodies against it. There is a very small population of people in whom Botox does not work as well over time and this has been hypothesized to be due to antibody formation. The assumption is that since Dysport has a lower protein load than Botox, the risk of getting diminishing results after years of injections is less. Less antibody formation has also led many to speculate that Dysport could have a longer duration of effect than Botox, although with my early experience this is not the case.
The second possible advantage is that Dysport seems to “spread” more than Botox after injection. Greater diffusion of the product is an asset when treating the forehead, crow’s feet and excessive sweating because there is a smoother, wider effect of muscle relaxation and a more natural result. This may even be advantageous when treating men because they have stronger, larger facial muscles which can require greater than average doses of Botox for optimal results. Diffusion also means that patients may require fewer injections as each individual poke should cover a wider “halo” of activity or sweating. Fewer injections means less pain and less bruising. So far the product’s increased diffusion has not lead to an increase in unwanted side effects such as droopy eyelids.
Finally, Dysport appears to kick in a little faster than Botox, within one to two days versus two to four. This will be a plus for the patient who comes into the office on Friday wanting to look better for a party on Saturday night.
Dysport is priced roughly the same as Botox; however now that Allergan has some competition on the market, it will likely avoid further price increases.
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Branded Accutane (isotretinoin), which first went on the market in 1982 for the treatment of severe acne, is no longer available for prescription. The pharmaceutical company Roche Holding AG (Basel, Switzerland) announced that it was discontinuing sales and withdrawing Accutane from the market as of June 26, 2009. The pharmaceutical company made the decision on the heels of a lawsuit which awarded over $33 million in damages to users who said the drug was responsible for causing inflammatory bowel disease. In addition, Roche has been forced to spend large amounts of money to defend themselves against many personal-injury lawsuits, including six cases that Roche lost after trial. In addition to the high costs of lawsuits, the branded drug had been reduced to less than 5% of isotretinoin’s market share after a slew of generic competitors hit the market in 2002. Before the drug’s patent expired, Accutane was Roche’s second biggest selling drug.
The drug going off the market is a disappointment for those with severe or intractable cystic acne. Roche has also been a leader in developing a rigorous risk-management program alongside the FDA for the prevention of birth defects and education regarding Accutane’s possible health risks. The good news is that because the drug was not pulled for safety reasons, it’s generic competitors will remain available for prescription.
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Max Factor was the first makeup artist to develop false eyelashes in 1919, reportedly made of human hair and to be worn by a lovely young starlet. Today, long, thick lashes are not just for the Hollywood set. Women everywhere can have gorgeous lashes just a prescription away. Allergan (the makers of Botox® Cosmetic) have released the first and only FDA-approved eyelash growth stimulator called LatisseTM.
LatisseTM works by stimulating hair follicles in the resting stage to transition into the growth stage. It's like Rogaine for your lashes. The prescription comes in a box with a small dropper bottle and 60 disposable applicators. One drop is applied to the tip of the applicator, and then brushed over the skin at the base of the upper lashes, similar to how one would apply liquid eyeliner. The product is not meant for use on the lower lashes. Results should be apparent within two to four months of regular use and your eyelashes will revert to their normal length if use is discontinued.
The active ingredient in LatisseTM (bimatoprost ophthalmic solution 0.03%) is a drug first approved by the FDA in 2001 as a treatment for glaucoma. The most common side effects include skin or eye irritation and dryness. Rare side effects include discoloration of the eyelid skin and permanent brown discoloration of the colored part of the eye. While the product works well, the disposable applicators are inexpensive and bulky, making it difficult to apply just to the lashline while limiting exposure to the surrounding skin. Some may want to substitute a fine, thin, soft brush such as a liquid liner or art brush, although the new brush must be kept clean to avoid risk of infection through contamination.
Some patients are using the product off-label to help regrow thin or overplucked eyebrows, however the safety and effectiveness of the product for use outside of the upper eyelashes has not been studied. It may also help regrow lashes in cancer patients and alopecia sufferers. It's possible Latisse could also be used at some future point in a formulation for scalp hair growth, though Allergan has yet to explore alternative indications. For now, lashionistas should stick to application on approved areas only (upper eyelashes). Visit http://www.latisse.com/ for before & after photographs more information.