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The U.S. Food and Drug Administration has approved a new treatment for moderate-to-severe frown lines, medically called nasolabial folds.
BioForm Medical issued a statement describing its Radiesse as a longer-lasting alternative to existing wrinkle fillers. The company said its calcium-based microsphere technology not only fills in facial folds and depressions, but also stimulates the body to produce collagen, the fibrous protein that gives the face its structure and fullness.
The drug was also newly approved to improve the appearance of people with AIDS-causing HIV who have significant facial fat loss (lipoatrophy), the San Mateo, Calif.-based company said.
Radiesse was first FDA approved in 2002 for use in facial reconstructive surgery.
HealthDay News, December 28, 2006
Findings from a new study confirm that tea extracts applied to the skin promote the repair of damage from radiotherapy, and shed light on the mechanisms involved in the injury...
The Abbott Laboratories drug Humira (adalimumab) has been given expanded approval by the U.S. Food and Drug Administration to slow structural joint damage in people with psoriatic arthritis. The condition affects people who have skin psoriasis.
Humira was initially approved for overall treatment of psoriatic arthritis in October 2005. It's also been sanctioned to treat moderate-to-severe rheumatoid arthritis, and an inflammatory disease of the spine called ankylosing spondylitis.
Psoriatic arthritis combines symptoms of arthritis—including joint pain and inflammation—with those of psoriasis, including painful red lesions on the skin. Clinical testing on 313 people who hadn't responded to NSAID therapy found that people given Humira had significantly less joint damage than study participants who took a non-medicinal placebo, Abbott said in a statement.
People who took Humira also demonstrated increased ability to perform daily functions such as getting dressed, walking, and climbing stairs, the company said.
HealthDay News, November 14, 2006
Acupuncture and an extract of turmeric—the spice that gives curry its kick—may both offer significant pain relief to some arthritis patients, two new studies suggest.
Reporting in the November issue of Arthritis & Rheumatism, a German team says a combination of acupuncture and conventional medicine can boost quality of life for patients suffering from osteoarthritis.
And in a second study in the same issue, American researchers say the ingestion of a special turmeric extract could help prevent or curb both acute and chronic rheumatoid arthritis.
The findings should be heartening to the roughly 40 percent of arthritis patients in the United States who say they've turned to some form of alternative medicine.
"If I had arthritis, I would be very excited about this," said Dr. Janet L. Funk, the lead author of the turmeric study and an assistant professor of physiological sciences at the University of Arizona in Tucson.
According to the Arthritis Foundation, nearly one in five Americans (46 million) suffers from one of the more than 100 various joint diseases that constitute arthritis. An additional 23 million have chronic joint pain that has yet to be formally diagnosed.
Osteoarthritis is caused by a progressive degeneration of bone cartilage and is the most common type of arthritis in the United States. Rheumatoid arthritis is an immunological disorder characterized by a painful inflammation of the lining of the joints.
In her study, Funk built on earlier research she had conducted with rats. Those efforts suggested that turmeric might prevent joint inflammation.
In her current work, she first broke down the specific contents of commonly sold turmeric dietary supplements.
In the lab, she and her colleagues then isolated a turmeric extract that was free of essential oils and structurally similar to that found in commercial varieties. The extract was based largely on curcuminoids—a compound they believed to be most protective against arthritic inflammation.
Funk's group administered the extract to female rats both before and after the onset of rheumatoid arthritis. They then tracked changes in the rodents' bone density and integrity.
The turmeric extract appeared to block inflammatory pathways associated with rheumatoid arthritis in rats at a particularly early point in the development of the disease. The extract had a beneficial impact if given three days after arthritis set in, but not if given eight days after disease onset.
Investigations in the laboratory revealed that turmeric stops a particular protein from launching an inflammatory "chain reaction" linked to swelling and pain. The expression of hundreds of genes normally involved in instigating bone destruction and swelling was also altered by the turmeric.
Funk stressed, however, that the findings are preliminary, and the extract needs to be tested in people.
"I feel an obligation to make clear that people should not run out to buy and consume turmeric powder," she cautioned. "First of all, a very small percent of the ground-up root that we buy in the grocery store is the protective part of the root, so it's not going to get you anywhere." In fact, the compound used in the study probably makes up only about 3 percent of the weight of current store-bought turmeric supplements, Funk said.
"That means that if this pans out in further studies, patients will be taking a purified extract, and this is all really exciting," she said. "But we still need conclusive proof that this extract is safe and efficacious."
In the second study, researchers led by Dr. Claudia M. Witt of Charite University Medical Center in Berlin spent three years tracking the treatment results of 3,500 male and female osteoarthritis patients suffering from either knee or hip pain.
For six months, all the participants were permitted to continue whatever conventional western medical treatments they had been undergoing prior to the onset of the treatment trials.
However, in addition, over 3,200 of the patients also received up to 15 sessions of needle-stimulation acupuncture during the first three months of the study. The remaining 310 patients received no acupuncture in the first three months. They were offered such treatment in the final three months of the study period, however.
All acupuncture sessions were administered by physicians who had received a minimum of 140 hours of certified training.
Symptom and pain questionnaires were completed at the onset of the study and at three months and six months of therapy.
Patients with chronic osteoarthritis pain who underwent a combination of routine medical care plus acupuncture demonstrated significant quality of life improvements, the researchers found. This included increased mobility and pain reduction above and beyond that experienced by patients who did not receive acupuncture.
For those who began their acupuncture treatments immediately, osteoarthritis improvement held steady three months after cessation of the sessions. For those patients who had begun acupuncture three months into the study period, comparable improvements occurred by the time they ended their sessions at the six-month mark.
The authors said acupuncture appeared to be a safe medical intervention with minor side effects observed in just over 5 percent of patients.
The study, one of the largest of its kind, demonstrated that acupuncture was a viable therapeutic option for people suffering from osteoarthritis, the German team said.
"I'm not surprised that people can be treated with acupuncture and get better," said Marshall H. Sager, a Bala Cynwyd, Pa.-based doctor of osteopathic medicine, acupuncturist, and past president of the American Academy of Medical Acupuncture.
"Using acupuncture adjunctively with western medicine is very common, because if you can do both approaches, you're way ahead of the game," he said. "Some people are not amenable to medication, either because of allergenic effects or because they just don't want to consume artificial things. And so, this is a way to start the healing process by engaging and stimulating the body's own inherent ability to heal itself."
However, Sager cautioned that American patients who consider this alternative route should choose carefully when they seek out acupuncture care.
"'Medical acupuncture' is acupuncture as practiced by a physician, which is much different than acupuncture as practiced by non-physicians in the east, such as in China," he noted. "And I would most definitely recommend that patients in the west deal with a physician that's properly trained and a member of the American Academy of Medical Acupuncture," Sager said.
By Alan Mozes, HealthDay Reporter, October 30, 2006
A new combination treatment offers hope to people who have the blistering, potentially fatal skin disease known as pemphigus vulgaris.
By combining the cancer-fighting drug rituximab with intravenous immune globulin, Harvard doctors have discovered a therapy that can effectively treat people with cases of pemphigus vulgaris that haven't responded to other treatments.
"We got a home run with this combination," said study co-author Dr. Marshall Posner, medical director of the head and neck oncology program at the Dana-Farber Cancer Institute and Harvard Medical School.
"These patients were extremely ill and on multiple medications," he said. "This therapy resulted in complete eradication of the disease for nine patients." The remaining two patients in the study required additional doses of the treatment before they, too, went into remission. All of those involved in the study had sustained remissions, some as long as 37 months, by the end of the study.
Results of the study are published in the Oct. 26 issue of the New England Journal of Medicine.
Pemphigus vulgaris is a rare autoimmune disease that causes the skin cells to stop adhering to one another. Blisters and lesions form, usually beginning in the mouth and then spreading to the skin.
"Before the discovery of corticosteroids, it was fatal within five years. People lost the surface of their skin, and died horrible deaths," explained Dr. John Stanley, chairman of the department of dermatology at the University of Pennsylvania School of Medicine. "This is an instructive disease about the power of the immune system. While it's usually used for good, it can actually destroy you."
Stanley co-authored a review article in the same issue of the journal about pemphigus and other dermatological diseases.
Currently, the first line of treatment for this devastating skin condition is prednisone, a corticosteroid. While it's often an effective treatment, it has numerous side effects that can be serious, so people generally can't stay on high doses for a long time. Other medications used are immune-suppressing agents that also carry the risk of serious side effects, such as infection.
Posner said most deaths from pemphigus occur as a result of immune-system suppression. But without suppressing the immune system, people with pemphigus would continue to develop blisters and erosions in their skin, giving bacteria an easy entry into the body.
Another treatment option is intravenous immune globulin. This option is usually reserved for those who don't respond to the other treatment options. Stanley said scientists aren't sure how this therapy works, but it may be that it replaces the immune-system antibodies that are attacking the skin cells with healthy antibodies.
For most people, these treatments options have proved lifesaving, and people with the disease often do well, said Stanley.
However, there are people who don't respond to any of the currently available treatments. And, the 11 people treated in the new Harvard study fell into that category. None of the available treatments had worked for them, and the disease was covering more than 30 percent of their body's surface area.
Each study volunteer received two cycles of rituximab weekly for three weeks. During the fourth week, they received a dose of intravenous immune globulin. Then, they received monthly infusions of both rituximab and IV immune globulin for four months.
During the initial treatment, nine of the 11 study participants went into remission for an average of 32 months. The remaining two required additional treatments about six months after treatment, but subsequently went back into remission.
While previous research on rituximab has sometimes found serious side effects, such as allergic reaction, Posner said there were virtually no side effects seen in this trial.
He said he thinks this drug combination would likely be helpful in less severe cases of pemphigus vulgaris, and he added that it could potentially be useful for treating other autoimmune diseases, such as rheumatoid arthritis, systemic lupus and type 1 diabetes.
"This therapy offers hope for this disease, and it could lead the way to treatment for other diseases that have a big impact on people's lives -- it needs to be investigated in other diseases so we can see how it works in other situations," Posner said.
Stanley said he doubted that rituximab would become a first-line treatment for pemphigus vulgaris anytime soon because the medication is quite costly and insurance companies would likely balk at paying for an expensive drug that isn't FDA approved specifically for treating pemphigus. The problem, he added, is that because pemphigus is so rare, it would be difficult to conduct a large enough trial to get such approval.
But, Posner suggested that while the rituximab/immune globulin combination treatment is more expensive initially, a cost analysis comparing all of the costs, including hospitalizations, might find the combination treatment is the cheaper alternative in the long run.
By Serena Gordon, HealthDay Reporter, October 26, 2006
Black tea eases stress by lowering blood levels of the stress hormone cortisol, says a British study in the journal Psychopharmacology.
The six-week study of 75 people found that those who drank black tea were able to de-stress more quickly than those who drank a caffeinated tea substitute, BBC News reported.
The participants were assigned challenging tasks while their cortisol, blood pressure, blood platelet, and self-rated levels of stress were measured by the researchers. During these tasks, both groups of study participants experienced large increases in blood pressure, heart rate, and self-rated levels of stress.
However, 50 minutes after the stressful tasks, cortisol levels dropped by an average of 47 percent among those who drank black tea and 27 percent among those who drank the tea substitute.
The study also found that the tea drinkers had lower blood platelet activation, which is associated with blood clotting and heart-attack risk, BBC News reported.
It's unclear which ingredients in black tea help reduce stress, the University College London researchers said.
HealthDay News, October 6, 2006
The Cosmetic, Toiletry, and Fragrance Association (CTFA) announced today that it has filed comprehensive comments with the Food and Drug Administration (FDA) on the science and regulation of nanoparticles in personal care products. CTFA comments, which can be found at www.ctfa.org, specifically address issues raised in a petition filed with the FDA earlier this year on the use of nanotechnology in personal care products, in particular, sunscreen products.
“Nanoparticles in sunscreens are very small particles that have been reviewed and approved by FDA. They have been used safely and effectively by consumers for decades to protect from harmful UV rays and to prevent skin cancer,” said John Bailey, executive vice president for science at CTFA and former FDA official. “These ingredients have properties that provide a greater degree of protection from the sun, are transparent when applied and aesthetically pleasing, and therefore encourage greater consumer acceptance.”
The nanoparticles in sunscreens, titanium dioxide and zinc oxide, are established, efficacious sunscreen filters that have been on the market for decades. In 1996, FDA concluded that smaller, micronized particles of titanium dioxide are not new substances and that there is no evidence demonstrating that these micronized particles are unsafe. Nano-sized titanium dioxide and zinc oxide, unlike the larger particle size ingredient, form a transparent rather than a thick, white coating, which leads to greater consumer acceptance and use of sunscreen products, and therefore greater protection from skin cancer and other damaging effects of the sun. The same improvement in formulation esthetics also applies to the use of these materials in cosmetics.
“Nanoparticle ingredients in personal care products sit on top of the skin, are used in small amounts, and are not absorbed into the body. The general scientific consensus is that there is no risk to human health. But we don’t rest on this knowledge alone,” Bailey said. “We take the science of safety very seriously, and that is why we review the latest and most comprehensive scientific research, including nanotech research, before bringing a product to market.”
According to widely accepted independent research studies, the size of these nanoparticles does not make them inherently different in terms of toxicity or impact on human health than larger particles. It is also important to note that humans have long been exposed to some types of nanoparticles in the atmosphere such as smoke from candles, fireplaces and other sources.
In the case of the sunscreen ingredients zinc oxide and titanium dioxide, the overwhelming weight of the scientific evidence states that these substances are safe and non-toxic, including when used in cosmetics and sunscreens.
Authoritative bodies that have thoroughly reviewed titanium dioxide and zinc oxide include:
- The FDA:
Concluded that these substances are safe for use in cosmetics. Titanium dioxide has been approved for use as a color additive in food, drugs, cosmetics, and contact lenses. Zinc oxide is approved for use as a food ingredient, a color additive in drugs and cosmetics, and as a protectant for injured skin.
Concluded that these substances are safe for use in OTC drug products, including sunscreens, skin protectants, and other products.
- The Scientific Committee for Cosmetic Products in the European Union:
Considered more than 100 titanium dioxide safety studies and concluded that these substances are safe for use in cosmetics.
- Germany BfR, Federal Agency for Risk Assessment:
In 2006, reviewed these two substances and found that the nanoparticles did not penetrate the skin, and that the biological properties of the nanoparticles were not necessarily different from those of larger particles.
- The Australian government Department of Health and Aging:
In 2006, published a comprehensive review of the science on zinc oxide and titanium dioxide and found no evidence that sunscreens containing these materials in nanoparticle form pose any risk.
“The FDA has broad authority to ensure that personal care products and ingredients utilizing nanotechnology are safe for consumers and has consistently exercised that authority,” CTFA’s Bailey added. “Sunscreens, some of which utilize sun-protecting nanoparticles, are required to go through an extensive pre-market review process to prove they are safe and effective.”
The FDA comprehensively regulates the safety of consumer health products. Under the Federal, Food, Drug, and Cosmetic Act (FFDCA), FDA has erected a complex and comprehensive regulatory system to safeguard the public health. This regulatory system has worked to ensure that, among other things, the food eaten by US consumers, the medical technology used by physicians and patients, and the personal care products used by countless citizens are among the safest in the world.
Based in Washington, D.C., CTFA is the trade association representing the cosmetic, toiletry, and fragrance industry in the United States and globally. Founded in 1894, CTFA has a membership of approximately 600 companies including manufacturers, distributors, and suppliers of the vast majority of finished personal care products marketed in the United States.
The Cosmetic, Toiletry, and Fragrance Association (CTFA) is requesting public comments by September 25, 2006, on a new Safety Evaluation Guideline addressing the topic of Skin Absorption.
The guideline describes in vitro test methods for evaluating skin absorption.
The CTFA Safety Evaluation Guidelines provide manufacturers with guidance regarding the use of preclinical and clinical safety testing as a means to substantiate the safety of both ingredients and finished cosmetic products. They are part of the CTFA Technical Guidelines series.
Each Guideline undergoes an extensive development and review process by CTFA technical committees and staff, as well as public review by CTFA member companies, nonmember companies, federal government agencies, and scientific professional societies.
An electronic copy of the draft guidelines is available from the CTFA Public Affairs Department by contacting Lisa Powers, (202) 446-0489 or email at firstname.lastname@example.org.
The FDA is seeking to ban over-the-counter sales of skin bleaching drug products.
The FDA cites the possible risk ofand skin discoloration from hydroquinone typically found in these products.
However, those cancer studies were done on rats, not people.
"The actual risk to humans from use of hydroquinone has yet to be fully determined," the FDA states in its proposal, published in the U.S. government's Federal Register.
The type of skin discoloration noted by the FDA is called exogenous ochronosis, a darkening of the skin. The FDA cites research linking the condition to hydroquinone use.
The FDA isn't proposing a ban on prescription skin bleaching drug products. But all such products would need to submit a new drug application for the FDA's review.
Not all skin lighteners contain hydroquinone. The FDA knows of 200 products containing hydroquinone in strengths from 0.4% to 5%, about two-thirds of which "appear to be marketed as OTC [over-the-counter] drugs," says the FDA.
The FDA is taking comments on its proposal until Dec. 27.
WebMD spoke with dermatologist Susan Taylor, MD, of Society Hill Dermatology in Philadelphia, and the Skin of Color Center in New York about the FDA's proposal.
"I feel that hydroquinones are safe and effective treatment for pigmentary disorders," Taylor says. "I feel comfortable recommending that my patients continue to use hydroquinones if they have a pigmentary disorder."
"I think the evidence is quite weak with the link between hydroquinones and cancer," Taylor tells WebMD.
"Data on rats and mice cannot necessarily be extrapolated to human data," she says.
"In Africa, people have used hyrdoquinones for long periods of time ... meaning years, 10, 20, 30, years ... and at high concentrations," Taylor says. "We've not seen a proliferation of various types of cancers reported from that population.
Exogenous ochronosis is rare in the U.S., Taylor notes.
"If you look at the case reports, it's probably less than 200," Taylor says. "So it's really not a significant problem here in the United States."
Millions of Users
Taylor points out that "many patients have disorders that are truly disfiguring and devastating. And these conditions can be improved significantly with hydroquinone products."
"It's important therapy and it's used by millions and millions of people," Taylor says.
She says hydroquinone products are primarily used to lighten dark areas of the skin due to conditions including injury,, , and sun damage.
"So there are real problems and this is a real solution," Taylor says. She adds that filing new drug applications can cost millions of dollars.
"My concern is that we could lose prescription products that we have," Taylor says. "That would have major consequences, I think."
"It's safe, effective; it's the gold standard, and I think our patients would benefit from continued use for these problems. I think those three points sum it up for me," Taylor says.
SOURCES: U.S. Government Printing Office, Federal Register, Aug. 29, 2006; vol 71: pp 51146-51155. Susan Taylor, MD, Society Hill Dermatology, Philadelphia, Skin of Color Center, New York.
By Miranda Hitti, WebMD, August 30, 2006
By Howard Murad, MD
Find out how spa professionals can combat cultural stress in today's society.