As more people look for ways to turn back the clock or improve their appearance, dermatologists are pioneering many of the newest aesthetic laser technologies — from tattoo removal to erasing fine lines and wrinkles to reducing fat or cellulite. Before considering any cosmetic procedure, dermatologists recommend that consumers do their homework to better understand the best technologies available for their specific needs.Information was provided by board-certified dermatologist M. Christine Lee, MD, FAAD, assistant clinical professor of dermatologic surgery at the University of California, San Francisco and director of a private practice in Walnut Creek, Calif.Treatments for Cellulite, Excess Fat Now Produce Long-Lasting ResultsCellulite and excess fat are two of the biggest hurdles that many women face in their quest to improve their appearance. While diet and exercise can help reduce body fat, cellulite is resistant to these types of lifestyle changes. Unique to women, Dr. Lee estimates that cellulite affects 80 percent of women regardless of their body weight. Until now, no cellulite treatment could dramatically change the appearance of cellulite, and any results were temporary.1440 Nanometer Laser• First minimally invasive laser treatment to treat cellulite approved by the Food and Drug Administration (FDA) in 2012 and provides long-lasting, dramatic results.• Surgical procedure involves inserting a tiny fiber optic beneath the skin to break the fiber bands responsible for cellulite in women. The laser releases the skin and allows the depressions (or dimpling that gives cellulite its appearance) to rise to the surface of the skin. Once the laser beam severs the fiber bands, the blood supply to this area is cut off so the bands do not regrow, and collagen production is stimulated.• Multiple areas can be treated with only one session, and the most common treatment areas are the buttocks, hips and thighs.• Some downtime is required after the procedure, due to bruising and swelling that can take one to two weeks to resolve.Cryolipolysis• Non-invasive procedure approved by the FDA to remove localized areas of fat in the lower abdomen and along the sides of the body.• Works by freezing the lipids in fat cells, which then slowly dissolve without injuring surrounding tissues.• Typically, three treatments are needed to dissolve an inch of fat.• Results are not immediate, as it takes three to four months to see a noticeable improvement.Ultrasound• Non-invasive procedure approved by the FDA uses high-intensity, focused ultrasound energy to destroy or melt targeted fat without harming surrounding skin.• Used to reduce fat bulges in the abdomen, with the average reduction of about an inch per treatment session. Can also be used on the thighs or other large areas of fat.• Results are not immediate, requiring two to three months.• An added benefit is noticeable improvement in the appearance of cellulite in the months following the procedure.These newer treatments provide alternatives to liposuction, which has been used to remove pockets of fat for decades but is more invasive and requires more downtime. …Read more
A few months ago, we wrote about Zohydro – the controversial painkiller approved by the FDA last October. Despite its controversy and attempts to block its release, the opiate hits the market this week. Health care and addiction recovery advocates are still pushing for an appeal, as they fear widespread abuse of the painkiller while opiate abuse has reached epidemic levels in the US.The controversy over Zohydro lies in the fact that it is a pure hydrocodone drug, without acetaminophen or other drugs added to it, making it 5 times stronger than other popularly abused opiates. In addition, it is crushable when most crushable painkillers were taken off the market a few years ago. Large scale efforts were made to remanufacture opiates like Percocet and OxyContin to …Read more
When acupuncture first became popular in the western hemisphere it had its doubters. It still does. But over time, through detailed observation, scientists have produced real evidence that ancient Chinese practitioners of the medical arts were onto something.Now new research documents a direct connection between the use of acupuncture and physical processes that could alleviate sepsis, a condition that often develops in hospital intensive care units, springs from infection and inflammation, and takes an estimated 250,000 lives in the United States every year.”Sepsis is the major cause of death in the hospital,” says Luis Ulloa, an immunologist at Rutgers New Jersey Medical School who led the study, which has been published by the journal Nature Medicine. “But in many cases patients don’t die because of the infection. They die because of the inflammatory disorder they develop after the infection. So we hoped to study how to control the inflammatory disorder.”The researchers already knew that stimulation of one of the body’s major nerves, the vagus nerve, triggers processes in the body that reduce inflammation, so they set out to see whether a form of acupuncture that sends a small electric current through that and other nerves could reduce inflammation and organ injury in septic mice. Ulloa explains that increasing the current magnifies the effect of needle placement, and notes that electrification is already FDA-approved for treating pain in human patients.When electroacupuncture was applied to mice with sepsis, molecules called cytokines that help limit inflammation were stimulated as predicted, and half of those mice survived for at least a week. There was zero survival among mice that did not receive acupuncture.Ulloa and his team then probed further, to figure out exactly why the acupuncture treatments had succeeded. And they made a discovery that, on its face, was very disappointing. They found that when they removed adrenal glands — which produce hormones in the body — the electroacpuncture stopped working. …Read more
A chemical that can accumulate in seafood and is known to cause brain damage is also toxic to the kidneys, but at much lower concentrations. The findings, which come from a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN), suggest that officials may need to reconsider what levels of the toxin are safe for human consumption.The world’s oceans contain algae that produce certain chemicals that can be harmful to humans and other living creatures. Many of these chemicals are considered neurotoxins because they cause damage to the brain. The neurotoxin domoic acid, also called “Amnesic Shellfish Poisoning,” is a very stable, heat resistant toxin that is becoming more prominent in coastal regions, likely due to environmental changes. It can accumulate in mussels, clams, scallops, and fish, and the FDA has set a legal limit of domoic acid in seafood based primarily on its adverse neurological effects.Because domoic acid is cleared from the body by the kidneys, P. Darwin Bell, PhD, Jason Funk, PhD (Medical University of South Carolina), and their colleagues looked to see if the toxin might also have detrimental effects on these organs. By giving mice varying doses of domoic acid and the assessing animals’ kidney health, the team found that the kidney is much more sensitive to this toxin than the brain.”We have found that domoic acid damages kidneys at concentrations that are 100 times lower than what causes neurological effects,” said Dr. Bell. “This means that humans who consume seafood may be at an increased risk of kidney damage possibly leading to kidney failure and dialysis.” While the findings need to be verified in humans, the researchers would like to see increased awareness and monitoring of domoic acid levels in all seafood. They say that the FDA may also need to reconsider the legal limit of domoic acid in food due to its kidney toxicity.Story Source:The above story is based on materials provided by American Society of Nephrology (ASN). …Read more
Oct. 13, 2013 — Using intravenous (IV) acetaminophen with narcotics provides more effective pain relief to children having tonsillectomies, according to a study presented at the ANESTHESIOLOGY™ 2013 annual meeting. Additionally, the combination therapy saves costs due to reduced use of narcotics after surgery, reduced side effects and slightly quicker hospital discharge than in patients who receive narcotics alone.Share This:The quintessential children’s surgery performed on more than 500,000 patients a year was traditionally done for multiple tonsil infections. Today, more than 80 percent of tonsillectomies are done to correct breathing disorders that affect sleep, according to the American Society of Otolaryngology. Sleep apnea is the most common disorder.In February 2013, the U.S. Food and Drug Administration (FDA) issued a black box warning against the use of codeine (a narcotic) in children undergoing tonsillectomies or adenoidectomies. Certain children have an inherited ability that causes their liver to convert codeine into life-threatening or fatal amounts of morphine or “ultra-rapid metabolizers.” Because of the difficulty in determining which children might be ultra-rapid metabolizers of codeine, FDA issued the black box warning for all children.A study has shown that children with sleep apnea are highly sensitive to narcotic medications because there is a direct correlation between hypoxemia (low oxygen levels in the blood) and increased morphine sensitivity for these children. “Since the majority of tonsillectomies are done for sleep apnea, physician anesthesiologists must use extreme caution when administering narcotics,” said Rajeev Subramanyam, M.D., staff anesthesiologist, Cincinnati Children’s Hospital Medical Center. “This study found that combining IV acetaminophen with narcotics relieved pain better, allowing patients to leave the hospital quicker and reduce costs.”The study looked at two groups of tonsillectomy patients: the first group of 73 patients received intraoperative IV acetaminophen with narcotics; the second group of 66 patients received only intraoperative IV narcotics.The study found that routine use of IV acetaminophen with narcotics resulted in a 3.3 percent reduction in the number of patients who required additional “rescue” doses of narcotics after surgery. When patients received IV acetaminophen and narcotics, rather than narcotics alone, the acetaminophen/narcotic combination cost $17.12 less per patient. …Read more
Aug. 30, 2013 — A new study on mentholated cigarette use in the U.S. finds an increase in menthol cigarette smoking among young adults and concludes that efforts to reduce smoking likely are being thwarted by the sale and marketing of mentholated cigarettes, including emerging varieties of established youth brands.”Our findings indicate that youth are heavy consumers of mentholated cigarettes, and that overall menthol cigarette smoking has either remained constant or increased in all three age groups we studied, while non-menthol smoking has decreased,” says lead researcher Gary Giovino, PhD, professor and chair of the University at Buffalo Department of Community Health and Health Behaviors.Giovino, one of the world’s leading tobacco surveillance researchers, estimated menthol and non-menthol cigarette use during 2004-10 using annual data on nearly 390,000 persons 12 years old and older who took part in the National Surveys on Drug Use and Health. The data included more than 84,000 smokers.The results, which were published online in the international journal, Tobacco Control showed that:• Among cigarette smokers, menthol cigarette use was more common among 12-17 year olds (56.7 percent) and 18-25 year olds (45 percent) than among older persons (range 30.5 percent to 32.9 percent).• Menthol use was associated with being younger, female, and of non-white race or ethnicity.• Among all adolescents, the percent who smoked non-menthol cigarettes decreased from 2004-10, while menthol smoking rates remained constant.• Among all young adults, the percent who smoked non-menthol cigarettes also declined, while menthol smoking rates increased.• The use of Camel menthol and Marlboro menthol increased among adolescent and young adult smokers, particularly non-Hispanic whites, during the study period.”The study results should inform the FDA regarding the potential public health impact of a menthol ban,” Giovino says.”The FDA is considering banning menthol cigarettes, or other regulatory options,” he says. “This research provides an important view of the trends and patterns of menthol use in the nation as a whole. The FDA will consider these findings and findings from multiple other studies as it goes forward.”Giovino is particularly alarmed that the findings show youth are heavy consumers of mentholated cigarettes and the use of menthols is specifically associated with being younger, female and of non-white ethnicity.”This finding indicates that mentholated cigarettes are a ‘starter product’ for kids in part because menthol makes it easier to inhale for beginners,” says Giovino. “Simply stated, menthol sweetens the poison, making it easier to smoke. Young people often think menthol cigarettes are safer, in part because they feel less harsh.”When I was growing up, one of my older friends said he didn’t think that menthol cigarette smoking was that dangerous because he was told that they were good for you if you got a cold,” says Giovino. “It turns out that Kool was advertising that way for a long time but was stopped from doing so by the Federal Trade Commission (FTC) around 1955.”This ‘urban legend’ has persisted.”Read more
July 4, 2013 — “As an oncologist, when I sit with patients to discuss starting a new chemotherapy, their first questions are often ‘How will it make me feel?’ and ‘How did patients like me feel with this treatment?'” said Dr. Ethan Basch, MD, director of Cancer Outcomes Research at the University of North Carolina.In the July 10th issue of The New England Journal of Medicine, Dr. Basch calls for pharmaceutical manufacturers to collect rigorous information on how drugs impact symptoms and quality of life starting early in drug development, and for the U.S. Food and Drug Administration (FDA) to include this information in drug labels.”As patients live longer with cancer, they must increasingly choose among agents with varying efficacy-toxicity balances. And as approved drugs continue to yield only tiny median survival benefits, patients understandably want to know how their peers felt during and after a treatment,” said Dr. Basch.In 2011, the FDA approved 15 new anti-cancer drugs, but only one of them, ruxolitinib, included symptom information in the label — reporting that multiple symptoms improve substantially when patients take the drug. This was actually the first cancer therapy in more than a decade to include symptom information in its label. Cancer labels stand in contrast to non-cancer labels, which describe symptoms about 25 percent of the time.Research has shown that patients who experience worse symptoms and quality of life face a worse prognosis and are more likely not to follow treatment guidelines or may stop treatment altogether. The FDA has taken several steps to include the patient perspective in drug development, issuing guidance, collaborating with industry to develop standardized tools, and requesting funds from Congress to support these efforts.Dr. Basch argues that the culture of pharmaceutical development must shift to include direct patient input during the earliest stages of research. …Read more
June 17, 2013 — The first experimental drug to boost brain synapses lost in Alzheimer’s disease has been developed by researchers at Sanford-Burnham Medical Research Institute. The drug, called NitroMemantine, combines two FDA-approved medicines to stop the destructive cascade of changes in the brain that destroys the connections between neurons, leading to memory loss and cognitive decline.The decade-long study, led by Stuart A. Lipton, M.D., Ph.D., professor and director of the Del E. Webb Center for Neuroscience, Aging, and Stem Cell Research, who is also a practicing clinical neurologist, shows that NitroMemantine can restore synapses, representing the connections between nerve cells (neurons) that have been lost during the progression of Alzheimer’s in the brain. The research findings are described in a paper published June 17 by the Proceedings of the National Academy of Sciences (PNAS).The focus on a downstream target to treat Alzheimer’s, rather than on amyloid beta plaques and neurofibrillary tangles — approaches which have shown little success — “is very exciting because everyone is now looking for an earlier treatment of the disease,” Lipton said. “These findings actually mean that you might be able to intercede not only early but also a bit later.” And that means that an Alzheimer’s patient may be able to have synaptic connections restored even with plaques and tangles already in his or her brain.Targeting lost synapsesIn their study, conducted in animal models as well as brain cells derived from human stem cells, Lipton and his team mapped the pathway that leads to synaptic damage in Alzheimer’s. They found that amyloid beta peptides, which were once thought to injure synapses directly, actually induce the release of excessive amounts of the neurotransmitter glutamate from brain cells called astrocytes that are located adjacent to the nerve cells.Normal levels of glutamate promote memory and learning, but excessive levels are harmful. In patients suffering from Alzheimer’s disease, excessive glutamate activates extrasynaptic receptors, designated eNMDA receptors (NMDA stands for N-methyl-D-aspartate), which get hyperactivated and in turn lead to synaptic loss.How NitroMemantine worksLipton’s lab had previously discovered how a drug called memantine can be targeted to eNMDA receptors to slow the hyperactivity seen in Alzheimer’s. This patented work contributed to the FDA approval of memantine in 2003 for the treatment of moderate to severe Alzheimer’s disease. However, memantine’s effectiveness has been limited. …Read more
June 7, 2013 — A re-analysis of the data from a pivotal study of rosiglitazone found no increased risk of cardiovascular events associated with the controversial diabetes drug, according to researchers at the Duke Clinical Research Institute (DCRI).The DCRI study of the drug, marketed in the United States as Avandia, reassessed the original findings of a clinical trial called RECORD, which drew criticism during an advisory committee meeting of the U.S. Food and Drug Administration in July 2010.Findings from the DCRI re-adjudication study appear June 6, 2013, in American Heart Journal, and were presented June 5-6 at an advisory committee hearing of the FDA.Rosiglitazone has not been widely marketed in the United States since 2010, when the FDA restricted its use after studies showed it was associated with a higher risk of heart attacks; it is no longer marketed in Europe. The FDA required the new analysis, which was funded by the drug’s manufacturer, GlaxoSmithKline.”We were pleased to be chosen to perform this re-evaluation and we look forward to presenting our findings and being part of the FDA advisory committee discussion,” said Kenneth W. Mahaffey, M.D., associate director of the DCRI and lead author of the study.Mahaffey and colleagues conducted a broad examination of the RECORD study, using the original data and applying the study’s definition of deaths, suspected heart attacks and strokes.The researchers also expanded the analysis. First, they worked to identify participants who had not been counted in the original study after dropping out or declining to seek follow-up care. The effort was hampered by logistical challenges, but the DCRI analysis included 328 more patients than the original study.Additionally, the DCRI team conducted a fresh examination of the data using typical procedures and a systematic, unbiased and blinded approach to identify all potential deaths, myocardial infarction and stroke events and processed them for judgment by a team of physicians.”I am proud of the dedicated and professional way that the DCRI team approached this effort,” Mahaffey said.In their analysis using the original RECORD definitions of cardiovascular events, the DRCI investigators confirmed no meaningful difference between rosiglitazone and the comparison drug, metformin/sulfonylurea, reflecting results in the original RECORD study.When comparing the results between treatment groups using a contemporary set of cardiovascular endpoint definitions being developed by the FDA, the DCRI analysis also found little difference between the two drugs.These findings, along with the additional sensitivity analyses performed by DCRI, support the original RECORD results, suggesting that when using essentially the same raw data, the observations were not affected by different end points and other factors.”These analyses using the original RECORD or new FDA endpoint definitions show similar treatment effects of rosiglitazone compared with the original RECORD results,” the study authors conclude.In addition to Mahaffey, co-authors include Gail Hafley; Sheila Dickerson; Shana Burns; Sandra Tourt-Uhlig; Jennifer White; L. Kristin Newby; Michel Komajda; John McMurray; Robert Bigelow; Philip D. Home; and Renato D. Lopes.Mahaffey and several other study authors have received research grants and fees from GlaxoSmithKline. Full disclosures are available at www.dcri.orgRead more
Apr. 16, 2013 — Projected to start in the second half of 2013, researchers at Stony Brook University plan to begin phase IIa placebo-controlled clinical trials using a drug treatment method developed here to treat cellulite. The treatment method is licensed to BioSpecifics Technologies Corp. (“BSTC”), sublicensed to Auxilium Pharmaceuticals, Inc., (“Auxilium”), and uses clostridial collagenase histolyticum (“CCH”), an injectable form of the enzyme collagenase.
To date, there has been no Food and Drug Administration (FDA) approved treatment for cellulite, which is the normal fat beneath the skin that pushes against connective tissue (collagen) anchoring strands, causing a dimpled effect on the skin above it. According to the American Society for Aesthetic Plastic Surgery, up to 90 percent of women and 10 percent of men — millions of people worldwide — have cellulite.
Marie A. Badalamente, PhD, Professor Orthopaedics, and Alexander B. Dagum, MD, Professor of Surgery and Orthopaedics, Interim Chair of Surgery and Chief of Plastic and Reconstructive Surgery at Stony Brook University School of Medicine, are planning to be investigators in the pending trials. Their collaboration has led to the development of a collagenase injection method aimed at treating cellulite. The injection is designed to break down collagen that anchors cellulite dimples and, consequently, even out skin irregularities caused by the cellulite. They hope that their bench-to-bedside research will result in the first medically based effective and FDA approved treatment.
“We are looking for a standard and safe method of treating cellulite and one that can be effective for a long period of time,” said Dr.Badalamente, who explained that current approaches, such as laser therapy, massage treatments or topical creams show limited evidence of significantly reducing cellulite.
“While cellulite isn’t harmful, it is a serious cosmetic concern for many people who want to feel better about their appearance and who want to reduce cellulite as much as possible,” said Dr. Dagum. “There are many methods to remove cellulite but few have been supported in medical literature to be effective or potentially usable as a standard practice.”
In 2006 the researchers obtained an investigational new drug number from the FDA for CCH in the treatment of cellulite. They subsequently completed a phase I pilot clinical trial of 10 women treated at Stony Brook for cellulite.
Participants received CCH injections based on an assessment of cellulite on the back of their thighs. The area of cellulite was quantified in centimeters with photo documentation. On average, there was a 77 percent reduction of cellulite as soon as one day after the injection. After six months, the patients had on average a 76 percent reduction of cellulite in the injected area. Only minimal side effects were reported, such as, bruising, soreness and mild edema, shortly after the injection. After six months, the patients reported an average satisfaction score of 1.75 (1=completely satisfied, 4=not satisfied).
“We believe that a significant reduction of cellulite after six months from an injection that appears to be well-tolerated is promising for patients and warrants continued testing within the FDA regulatory process,” said Dr. Badalamente, summarizing their pilot study. She emphasized the overall study results were indicators of potential proof of concept for CCH efficacy and safety in treating cellulite.
The results of the study and additional evaluation of CCH by Auxilium prompted the company to expand the field of its license for CCH in January 2013 to include the potential treatment of adults with cellulite. Auxilium is currently licensed to market and distribute XIAFLEX® (an FDA-approved version of CCH) to treat adult Dupuytren’s contracture patients with a palpable cord, a debilitating hand disorder and is under FDA review for the potential treatment of Peyronie’s disease.
Auxilium is responsible for the research, development and potential use of CCH for the treatment of cellulite. This includes the development of clinical trials. Should a formulation of CCH receive FDA approval for this new indication, Auxilium will also be responsible for the commercialization, marketing, sales and distribution of CCH for the treatment of cellulite.Read more