Botox Linked To Respiratory Failure And Death, FDA Advises

Daily Science Journal (Feb. 11, 2008) — The U.S. Food and Drug Administration has notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA's ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.

The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

The FDA is not advising health care professionals to discontinue prescribing these products.

The agency is currently reviewing safety data from clinical studies submitted by the drugs' manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.

Adapted from materials provided by US Food And Drug Administration.

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New Skin-healing Chemicals, Green Tea And The 'Asian Paradox'

Daily Science Journal (Aug. 30, 2007) — Researchers have made synthetic lipids called pseudoceramides that are involved in skin cell growth and could be used in treating skin diseases in which skin cells grow abnormally.

Ceramides are lipids found in the outermost skin layer called the stratum corneum, which is made of dead skin cells and mainly serves as a physical barrier. Ceramides' main biological function is to control how skin cells grow and differentiate -- a process through which skin cells become specialized.

Scientists have created in the laboratory synthetic ceramides, called pseudoceramides, to treat skin diseases such as atopic dermatitis, a form of eczema characterized by red, flaky and very itchy skin; psoriasis, a disease that causes red scaly patches on the skin; and glucocorticoid-induced epidermal atrophy, in which the skin shrinks due to skin cell loss.

Jeung-Hoon Lee and colleagues have developed a new series of pseudoceramides and examined their effects on skin cells. They found that three pseudoceramides called K6PC-4, K6PC-5, and K6PC-9 significantly increased the amount of proteins produced when skin cells differentiate. These results were obtained both on cultured skin cells and on a reconstituted epidermis. K6PC-4, K6PC-5, and K6PC-9 may be used to treat skin diseases arising from abnormal growth of skin cells, the scientists concluded.

Article: "Novel synthetic ceramide derivatives increase intracellular calcium levels and promote epidermal keratinocyte differentiation," by Yoo Bin Kwon, Chang Deok Kim, Jong-Kyung Youm, Hyung Sub Gwak, Byeong Deog Park, Seung Hun Lee, Saewha Jeon, Bo Joong Kim, Young-Joon Seo, Jang-Kyu Park, and Jeung-Hoon Lee

Adapted from materials provided by American Society for Biochemistry and Molecular Biology, via EurekAlert!, a service of AAAS.

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Green Tea And The 'Asian Paradox'

There is a lower incidence of cardiovascular disease and cancer in Asia where people smoke heavily, which may be accounted for by high consumption of tea, particularly green tea, according to a review article published by a Yale School of Medicine researcher.

"We do not yet have a full explanation for the 'Asian paradox,' which refers to the very low incidence of both heart disease and cancer in Asia, even though consumption of cigarettes is greater than in most other countries," said Bauer Sumpio, M.D., professor and Chief of Vascular Surgery in the Department of Surgery. "But we now have some theories."

Sumpio, the lead author of the review in the Journal of the American College of Surgeons, said he and his colleagues reviewed more than 100 experimental and clinical studies about green tea in writing the article.

He said one theory is that the average 1.2 liters of green tea consumed daily by many people in Asia offers the anti-oxidant protective effects of the polyphenolic EGCG. EGCG may prevent LDL oxidation, which has been shown to play a key role in the pathophysiology of arteriosclerosis. EGCG also reduces the amount of platelet aggregation, regulates lipids, and promotes proliferation and migration of smooth muscle cells, which are all factors in reducing cardiovascular disease, he said.

Sumpio said other reports show that EGCG prevents growth of certain tumors. Tea, according to studies, also can improve gastrointestinal function, alcohol metabolism, kidney, liver and pancreatic function, protect skin and eyes and alleviate arthritis. Tea has been used in managing and preventing allergies, diabetes, bacterial and viral infections, cavities, reduce or cure diseases with an inflammatory component and improve neurologic and psychological health.

"More studies are necessary to fully elucidate and better understand green tea's method of action, particularly at the cellular level," Sumpio said. "The evidence is strong that green tea consumption is a useful dietary habit to lower the risk for, as well as treat, a number of chronic diseases. Certainly, however, smoking cessation is the best way to prevent cardiovascular disease and cancer."

Reference: Journal of the American College of Surgeons 202: 813-825 (May 2006)

Adapted from materials provided by Yale University.

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Theory Of Facial Aging Gets A Facelift

Daily Science Journal (Aug. 9, 2007) — The longstanding idea that the entire human face ages uniformly is in need of a facelift, say researchers at UT Southwestern Medical Center who have found that multiple, distinct compartments of fat in the face age at different rates.

Drs. Rod Rohrich (right) and Joel Pessa have discovered that the human face is made up of individual fat compartments that gain and lose fat at different times and different rates as people age. Facial aging is, in part, characterized by how these separate compartments change as we grow older. (Credit: UT Southwestern Medical Center)

The findings, published in a recent issue of Plastic and Reconstructive Surgery, challenge previously held theories regarding aging and may offer new ways to help turn back the clock, UT Southwestern plastic surgeons say.

"For hundreds of years, everyone has believed that the fat on the face is one confluent mass, which eventually gets weighed down by gravity, creating sagging skin," said Dr. Joel Pessa, assistant professor of plastic surgery and the study's lead author. "In our studies, however, we were surprised to find that this is not the case; the face is made up of individual fat compartments that gain and lose fat at different times and different rates as we age."

The study involved injecting different types of dye into facial cavities of 30 cadavers. Despite at least 24 hours of settling time, the dye, rather than permeating the entire face, stayed in separate areas -- showing that individual facial compartments have boundaries between them that act like fences. These fences, which seem to be composed of fibrous tissue, allow the face to maintain its blood supply should it become injured.

Dr. Pessa said the face resembles a three-dimensional puzzle, with fat divided into distinct units around the forehead, eyes, cheeks and mouth. Facial aging is, in part, characterized by how these separate compartments change as we grow older.

A youthful face is characterized by a smooth transition between these compartments. As people age, contour changes occur between these regions due to volume losses and gains as well as repositioning of the compartments. Eventually, this can result in sagging or hollowed skin and wrinkles.

"This is a revolutionary way of viewing facial anatomy. It not only tells us how we age, it shows us why we age the way we do, and why every part of the face, from the eyelids to the cheeks, ages differently," said Dr. Rod Rohrich, chairman of plastic surgery and senior author of the study. "This will help plastic surgeons around the world not only understand how we can better rejuvenate the face, but how people age as a physiological process."

This breakthrough could have tremendous implications in helping plastic surgeons target facial "trouble" areas and use injectible fillers to add volume to individual sections of the face. It could also aid in developing new and improved cosmetic and reconstructive surgery techniques, Dr. Rohrich said.

"Understanding how fat is compartmentalized will allow us to be very accurate and precise in how we approach facial rejuvenation," Dr. Pessa said. "This gives us an algorithm, or scientific approach, to help ascertain what areas of the face may need extra fat to combat the aging process. It also is a major breakthrough in facial anatomy that will have major implications for future studies on aging and possibly hold clues to the study of other diseases such as obesity, diabetes and cancer."

Adapted from materials provided by UT Southwestern Medical Center, via EurekAlert!, a service of AAAS.

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Cosmetic Surgery Techniques Can Enhance Thyroid Surgery Results

Daily Science Journal (Jul. 11, 2007) — Cosmetic surgery techniques, such as having a patient sit or stand while incision sites are marked so they blend into natural lines of the body, can improve the aesthetic result of thyroid surgery as well, researchers say.

Dr. David Terris, a pioneer in minimally invasive techniques that have dramatically reduced the size of the hallmark base-of-the-neck incisions. (Credit: Image courtesy of Medical College of Georgia)

"We have found that while keeping the management of the underlying thyroid problem as the first priority, we can still achieve a maximal cosmetic result," says Dr. David Terris, a pioneer in minimally invasive techniques that have dramatically reduced the size of the hallmark base-of-the-neck incisions.

Dr. Terris, who chairs the Medical College of Georgia Department of Otolaryngology-Head and Neck Surgery, wanted to know if cosmetic surgery principles he learned in the facial plastic surgery part of his training could further improve results.

He did a prospective analysis of 248 patients who required varying approaches to thyroid surgery, from a standard, several-inch-long neck incision to remove huge thyroids to minimally invasive techniques that cut the incision size in half to endoscopic approaches that reduce incision size half again. Patients were operated on at MCG Medical Center between September 2003 and June 2006.

Most thyroid patients requiring surgery are women – 198 women compared to 50 men in this new study published in the July issue of The Laryngoscope – and many are concerned with the cosmetic result, says Dr. Terris. "It matters to them how big the scar is, if it's even, if it's hidden in a skin crease, if the edges are nicely aligned."

All patients sat up to have their incision sites marked. "You want the incision to be in a location that corresponds to a cosmetically favorable area when you are upright at a dinner party, not stretched out on an operating room table," says Dr. Terris.

Other techniques applied included:

• Trimming traumatized edges at the incision sites. "Especially with the minimal-access techniques, the idea is to customize the incision to the size of the disease rather than one size fits all, which is how thyroid surgery was done just five or six years ago, with a big incision for everybody," says Dr. Terris. "Sometimes we still make big incisions, but more often, we make a smaller incision just big enough to get the thyroid out." Skin edges sometimes get frayed as surgeons remove large nodules from relatively small incisions. "Rather than make a bigger incision, we excise that edge so you have nice, fresh dges that come together quite well."
• Using surgical glues instead of sutures. "You can line up edges and get them accurately apposed without any risk of railroad-tracking using the glue," he says, referencing tracks left by traditional sutures or staples. "It's also convenient for patients because they don't have to come back on a certain date to get the stitches removed; they just peel it off."
• Minimizing trauma to surrounding skin. "The conventional way to get to the thyroid gland is to raise up the skin to the hyoid bone above the Adam's apple and down to the clavicles, then start working on the muscles in the throat that surround the thyroid gland, separate those, then get down to the gland." But all that raising of tissue, called flaps, means hoping it will lie back down as it's supposed to. "What we recognized is that you don't need to raise those flaps all the way up and all the way down. We make our incision, we go right down to the muscles, separate them, do the work we need to do, then close them. It saves time during surgery, it saves dissection and we are not creating a big space that we hope sticks back down."
• Minimizing use of drains. Drains to manage post-surgery oozing have been used pretty much since thyroid surgery was invented. "It used to be common, rather than removing the entire thyroid, to leave a little rind, if you will, of the thyroid behind," says Dr. Terris. The hope was the remaining tissue might reduce or even eliminate the need for thyroid medicine afterward. The reality is the patients ended up on medicine and the rind often caused oozing and sometimes recurrent disease. Now doctors take out the whole thyroid or all of one side, depending on the extent of the disease. Also today, minimally invasive techniques and other surgical improvements such as the thin, ultrasonic harmonic scalpel, have reduced overall surgical trauma. In the study, only 111 of the 248 patients got drains, 60 of whom had conventional thyroidectomy.

Researchers reported that only one of the 248 patients required additional treatment for their surgery scar; she received steroid injections for hypertrophic scarring.

"Although there continues to be enthusiasm for the use of these smaller incisions to accomplish thyroid surgery, it is likely that the application of well-known cosmetic principles is equally important to achieving optimal outcomes," Dr. Terris and his co-authors write.

Adapted from materials provided by Medical College of Georgia.

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The Elderberry Way To Perfect Skin

Daily Science Journal (Jul. 6, 2007) — Forget expensive moisturisers and cosmetic surgery, a compound found in the humble elderberry could give a natural boost to skin.

In the first study of its kind, researchers will explore whether the skin's condition is improved by a compound which gives berries their vibrant colour (called 'anthocyanin'). (Credit: iStockphoto)

In the first study of its kind, a team of researchers led by Prof Aedin Cassidy at the University of East Anglia and Dr Paul Kroon at the Institute of Food Research, will explore whether the skin's condition is improved by a compound which gives berries their vibrant colour (called 'anthocyanin').

In a 12-week trial starting in September, post-menopausal women will consume either extracts from elderberries or placebo capsules, and will have their skin's structure and appearance measured with state-of-the-art equipment used by experts in skin science. At the same time, researchers will also test whether the elderberry extract can reduce risk factors for heart disease.

"We already know that a healthy diet can help protect against heart disease and skin damage, and that a mixture of similar food components have been shown to improve the skin's structure. There is also evidence that the active components have anti-inflammatory properties, which may be important in helping people stay healthy," said UEA's Dr Peter Curtis who is leading the project.

"If the results of our study are positive, it may lead to innovations in skin health products and may also give us vital information about diets which promote healthier hearts."

Adapted from materials provided by University of East Anglia.

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Innovative Treatment For Migraines Combines Botox And Surgery

Daily Science Journal (Jun. 19, 2007) — Five years ago, Sharon Schafer Bennett suffered from migraines so severe that the headaches disrupted her life, kept her from seeking a job and interfered with participation in her children's daily activities.

Plastic surgeon Dr. Jeffrey Janis marks a site that, using the anti-wrinkle drug Botox, pinpointed a muscle later removed to help relieve Sharon Schafer Bennett's severe migraines. (Credit: Image courtesy of UT Southwestern Medical Center)

Now, thanks to an innovative surgical technique performed by a UT Southwestern Medical Center plastic surgeon who helped pioneer the procedure, the frequency and intensity of Mrs. Bennett's migraines have diminished dramatically -- from two to three per week to an occasional one every few months.

The technique -- performed by a handful of plastic surgeons in the U.S. -- includes using the anti-wrinkle drug Botox to pinpoint which of several specific muscles in the forehead, back of the head or temple areas may be serving as "trigger points" to compress, irritate or entrap nerves that could be causing the migraine. Because Botox temporarily paralyzes muscles, usually for about three months, it can be used as a "litmus test" or "marker" to see if headaches go away or become less intense while the Botox's effects last, said Dr. Jeffrey Janis, assistant professor of plastic surgery.

If the Botox is successful in preventing migraines or lessening their severity, then surgery to remove the targeted muscle is likely to accomplish the same result, but on a more long-term and possibly permanent basis, he said.

For Mrs. Bennett, the surgery proved to be life-altering.

"I can't even begin to tell you what a change this has made in my life," said Mrs. Bennett, 45, a Houston-area resident. "For the first time in years, I can live like a normal human being and do all the normal 'mom' and 'wife' things that the migraines physically prevented me from doing. My family thinks it's great because they don't have to put their lives on hold numerous times a week because of my migraines. I'm also going back to school to get a second degree, something I could never have considered before."

Dr. Janis said: "Many neurologists are using Botox to treat migraines, but they are making the injections in a 'headband-like' circle around the forehead, temple and skull. They are not looking at finding the specific location of the headache's trigger point. While patients may get temporary relief, after the Botox wears off they will have to go back and get more injections or continue medications for migraines.

"It's like a math equation. I will inject the Botox into one trigger point at a time and leave the others alone. The Botox is used as a diagnostic test to determine what trigger point is causing the problem. If patients get a benefit from the Botox, they likely will get a benefit from the surgery. If there's no benefit from the Botox, then there won't be a benefit from the surgery."

Dr. Janis began collaborating more than five years ago with Dr. Bahman Guyuron, a plastic surgeon at Case Western Reserve University and the first to explore using surgery to relieve migraines, following the revelation by several of his patients that their migraines had disappeared after they had cosmetic brow lifts. Dr. Janis has assisted his colleague by performing anatomical studies on cadavers to explore the nerves and pathways that might cause migraines. Together they have identified four specific trigger points and developed a treatment algorithm that includes using Botox prior to deciding whether to perform surgery.

During the past several years, numerous peer-reviewed articles have been published in Plastic & Reconstructive Surgery detailing their research efforts and the researchers have presented the technique at professional meetings of plastic surgeons.

Approximately 28 million Americans, 75 percent of those women, suffer from migraines, according to the National Institutes of Health. For employers, that translates into an estimated 157 million lost workdays annually.

"A migraine is something you can't explain to someone who hasn't had one," said Mrs. Bennett, who began suffering monthly migraines as a teenager. As she grew older, the headaches become more frequent and unpredictable. "They were messing up my life. I couldn't make any commitments or plan activities for my kids. This surgery has made a huge difference in my life. It's awesome."

Dr. Janis only sees patients who have been diagnosed with recurring migraines by a neurologist and have tried other treatments that have failed.

"Plastic surgeons are not in the business of diagnosing and treating headaches," he said. "This is a novel method of treatment that is proving to be effective and potentially more long lasting than other things used before. But it is still in its infancy."

Adapted from materials provided by UT Southwestern Medical Center.

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