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The Food and Drug Administration yesterday outlined a plan for tougher monitoring of the safety of medical devices once the products are on the market. It comes just after Democrats , who promise more aggressive oversight of the FDA, wrested control from Republicans in the House of Representatives and Senate.
The FDA said the timing of yesterday's plan was "totally unrelated" to the election outcome. The agency's plan includes an electronic system for reporting serious side effects, to replace the paper reports now filed by medical professionals and patients.
"The entire FDA post-marketing surveillance system is weak both for drugs and devices," said Dr. Steve Nissen , a Cleveland Clinic Foundation cardiologist scheduled to testify at a congressional hearing this month about the FDA. "Unfortunately, adverse event reporting is voluntary and, generally, only 1 to 10 percent of events are reported," Nissen said.
A Democratic-led Congress appears willing to make that and other FDA improvements, starting by shuffling a few key committee chairmen.
Democrats Edward M. Kennedy of Massachusetts , Henry A. Waxman of California , and Bart Stupak and John D. Dingell both of Michigan are poised to head key congressional panels with investigatory powers and FDA oversight.
"With congressional oversight, [the FDA is] going to face a much tougher, much tougher environment," said John Manthei , a partner in the Washington, D.C., office of Latham and Watkins LLP . "Mr. Waxman and Mr. Dingell and Mr. Stupak have made it very clear that FDA is squarely within their crosshairs," said Manthei, FDA counsel for the Medical Device Manufacturers Association .
Kennedy has co sponsored reform legislation that, among other changes, shifts planning for how to handle emerging drug risks to the preapproval phase—when the FDA has more clout—and provides more drug-safety funding.
The FDA said that its plan will help it better detect and take action on risks related to thousands of medical devices, such as mesh stents used to prop open clogged arteries, pacemakers, and implantable defibrillators that tame irregular heart beats.
The agency is under fire for underestimating such problems as long-term heart risks attributed to drug-eluting stents, manufactured by companies that include Natick's Boston Scientific Corp . The FDA relied on short-term studies for the approvals. Next month , it will convene an advisory panel to discuss cardiovascular safety data from longer-term use.
In addition to the electronic reporting system for side effects, the FDA already has assembled a network of 350 hospitals that report problems with devices, shortening the time it takes for the agency to learn about problems. Dr. Daniel Schultz , director of the FDA's Center for Devices and Radiological Health , said the agency will more aggressively tap that database.
In addition, medical devices soon could carry "unique identifiers" that make it easier to track them down, permitting more focused recalls of problematic models.
By Diedtra Henderson, Boston Globe Staff, November 10, 2006
Good news for sleepless new parents—research shows that massage helps newborn babies sleep more and cry less.
Massage also lowers stress levels in infants and helps the bonding process with the parent, it was claimed.
The study found that infants under six months who received massage also had lower levels of the stress hormone cortisol compared to babies who had not.
A team of researchers from Warwick Medical School and the Institute of Education at the University of Warwick looked at nine massage studies covering 598 babies under six months old.
Babies were massaged by parents who had been trained by health professionals and the infants who received massage were found to have beneficial effects.
One of the studies found that massage could affect the release of the sleep hormone melatonin, helping babies' sleeping patterns.
Another showed that babies in an orphanage who usually had little tactile stimulation grew faster, were less ill and had less clinical visits when they were given massage, made eye contact with and spoken to.
The researchers also found that massage built better relationships between babies and mothers who had postnatal depression.
Angela Underdown, who led the research, said: "Given the apparent effect of infant massage on stress hormones, it is not surprising to find some evidence of an effect on sleep and crying.
"It gives parents and babies intimate time. We haven't said that it should be on offer to everyone, but massage does no harm, and it improves a number of factors. It seems to have some effect on sleep and relaxation.
"We looked at babies under six months because that's when parents and babies are forming their attachments and babies are forming their sleep patterns."
Life Style Extra, November 8, 2006
Aromatherapy is an affordable, accessible natural path to relief for a variety of health problems, ranging from arthritis pain to nausea to drowsiness, supporters insist.
But skeptics dismiss any claims that the use of essential oils from flowers, herbs and trees can promote health in any way.
And both sides are unlikely to relinquish their positions anytime soon.
Aromatherapy "works for so many different things, it is amazing," said Kelly Holland Azzaro, a registered aromatherapist in Banner Elk, N.C., and vice president of the National Association for Holistic Aromatherapy (NAHA), an industry trade group. "You can experience aromatherapy by inhalation by putting one drop of an essential oil on a tissue and inhaling," she said.
According to the NAHA, aromatherapy is the "art and science of utilizing naturally extracted aromatic essences from plants to balance, harmonize and promote the health of body, mind and spirit." These essences are then distilled into "essential oils"—highly concentrated aromatic extracts—that are derived from a "variety of aromatic plant material, including grasses, leaves, flowers, needles and twigs, peels of fruit, wood and roots."
Among the most popular essential oils, which are widely sold at health-food stores and over the Internet, are eucalyptus, geranium, lavender, lemon, peppermint, rosemary, and tea tree, and according to the NAHA.
"Uplifting scents such as citrus can keep you awake at work," Azarro said. "To help increase alertness, use rosemary and lemon." And to combat nausea, try essence of peppermint, ginger and orange, she added.
While research into aromatherapy's benefits is limited, there are some studies that suggest certain treatments can help ease some symptoms.
For instance, in a 2005 study published in the journal Chronobiology International, researchers reported that lavender aromatherapy helped all 31 men and women feel more "vigor" the next morning, compared to the night they breathed in distilled water, an exercise that served as the control setting.
A study in the March-April 2006 issue of the Journal of Midwifery & Women's Health said that aromatherapy, combined with massage, helped new mothers feel less "blue" and anxious, compared to mothers of newborns who didn't get the treatment.
And a review published in Holistic Nurse Practitioner found that patients with postoperative nausea and vomiting can be helped by aromatherapy as well as acupressure and acupuncture.
But critics find little of value with scent therapy—or even label it as therapy.
"It's not a therapy, it's a set of products with odors," said Dr. Stephen Barrett, board chairman of Quackwatch Inc., an Allentown, Pa.-based organization that says it fights health fraud and quackery.
"If people like the odors and want to pay for them, I would have no objection," Barrett said. However, he added, don't expect much. "There is no evidence that aromatherapy can alter the course of any disease. There is no logical reason to believe that any such evidence will ever be found," he said.
As for potential risks, Barrett said: "Some people find certain odors irritating. People who use aromatherapy with the hope that it will cure what ails them will waste money."
Azzaro said that, currently, aromatherapy is unregulated in the United States. "And that's part of the issue," she said. People don't understand exactly what it is, either. "People think it's potpourri or a smelly candle."
There's also no state licensing for aromatherapists in the United States. Most practitioners incorporate their training with another profession, such as licensed acupuncturist or registered nurse, according to the NAHA.
If you're interested in pursuing aromatherapy, Azzaro said it's best to ask a practitioner about his or her specific training. "And when you purchase oil, such as from a health-food store, hopefully some educational materials are with the product," she said.
Be aware, too, there can be the possibility of allergic reactions to some treatments.
By Kathleen Doheny, HealthDay Reporter, November 2, 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
The bumps (papules) and pimples (pustules) of rosacea, a poorly-understood facial disorder affecting an estimated 14 million Americans, may be the result of an allergy-like reaction to environmental and emotional triggers, according to new study results presented at the National Rosacea Society (NRS) research workshop during the annual meeting of the Society for Investigative Dermatology and reported in Rosacea Review.
"We are very excited about these findings because they may provide the basis for improving the treatment and management of this condition," said Dr. Richard Gallo, chief of the division of dermatology at the University of California-San Diego and lead investigator of the NRS-funded study. "By defining the process leading to the inflammation, new medications might be developed to block these effects."
Dr. Gallo explained that when the normal immune system is faced with any of a broad range of potential dangers—such as sun exposure, emotional stress, heat and spicy foods, among many others—receptors recognize potential threats and protect the body by prompting the production of protective substances that isolate and neutralize any harmful effects. With rosacea, however, these protective substances turn the body on itself like overzealous guards, leading to inflammation.
Using advanced mass spectrometry technology to analyze the biochemical composition of proteins in rosacea patients, the researchers discovered an abnormality in the production of protective molecules known as cathelicidins, Dr. Gallo said. In normal patients, the cathelicidins are found in a form that is inactive and would not lead to bumps and pimples. In rosacea patients, the forms of cathelicidins are different and lead to skin inflammation. The cause of this abnormality in cathelicidins seems to be due to an equally important problem in rosacea—an overabundance of yet another substance, called kallikrein, which can spur dormant cathelicidins into action.
"It appears that the combination of these two substances at abnormally high levels is a double whammy for rosacea patients," Dr. Gallo noted.
The researchers recently completed the picture when they were able to demonstrate that this process is linked to the actual formation of rosacea signs and symptoms. The skin of mice injected with the cathelicidins found in rosacea patients showed a dramatic inflammatory response—including bumps and pimples—while mice injected with normal cathelicidins showed no inflammation, either visually or under a microscope.
"The next step is to test these findings in human subjects through various therapeutic interventions," Dr. Gallo said. "As we gain a thorough understanding in humans, we can look for new medications that block this process in order to treat or prevent the inflammation associated with rosacea."
Rosacea is a chronic disorder that primarily affects the cheeks, nose, chin or forehead, and is often characterized by flare-ups and remissions. It typically begins as a flushing or redness that comes and goes, and visible blood vessels may also appear. Inflammatory bumps and pimples often develop, and in severe cases, the nose may become swollen and enlarged from excess tissue.
In addition to long-term medical therapy to bring the condition under control and maintain remission, patients are advised to keep a diary to identify and avoid lifestyle and environmental factors that may affect their individual cases. Some of the most common rosacea triggers include sun exposure, emotional stress, hot or cold weather, wind, heavy exercise, alcohol, hot baths and spicy foods.
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
By: Heather Woolery-Lloyd, MD
Discover the unique skin care challenges of various ethnic skin types and about some treatment options.
Massage therapy is effective in reducing hand pain and increasing grip strength, according to a new study funded by Biotone and conducted by the Touch Research Institutes (TRI) at the University of Miami School of Medicine in Miami, Fla. Arthritis is a systemic inflammatory disease, frequently located in the small joints of the hands. It affects the active, working-age population as well as the elderly, causing pain, activity limitations, and a lower quality of life. Many daily activities, for example, require considerable hand strength, such as opening doors, opening jar lids, lifting and carrying items. Hand strength in patients with arthritis is 75 percent lower than in healthy patients. “While massage therapy has decreased pain in several pain syndromes, including fibromyalgia, lower back pain and migraine, this is the first report of pain reduction in hand arthritis following massage therapy,” said Dr. Tiffany Field, TRI director. “Up to now, many other interventions to alleviate hand pain have been tried -- medications, physical therapy and various forms of exercise. The results of this study are very encouraging for the application of massage therapy as a complementary alternative treatment for hand arthritis.” Under the study, 22 adults ranging in age from 20 to 65 with wrist/hand arthritis were randomly assigned to a massage therapy or a standard treatment control group. The massage therapy group received massage on the affected wrist/hand once a week for a four-week period and also conducted self-massage on the wrist/hand at home daily. Biotone Polar Lotion was used in the massage therapy. The standard treatment control group did not receive massage therapy during the study. The massage therapy group had lower anxiety and depressed mood scores after the first and last sessions, and by the end of the study reported less pain and greater grip strength. The massage therapy group showed greater improvement than the standard treatment control group on all of these measures across the study period. “Biotone continues to fund research regarding the different effects of massage therapy on consumer's health and well being," said Jean Shea, Biotone founder and CEO. “The arthritis, breast cancer and back pain studies we funded all have shown positive results that are very encouraging. Our research studies, in addition to the many others being conducted worldwide, provide increased awareness and acceptance of massage therapy as an effective complementary alternative treatment." Biotone is supporting two research projects through the Massage Therapy Foundation for 2006. The research studies involve therapeutic massage for pediatric burn survivors and the effects of five minute foot massages on pediatric Intensive Care Unit patients. More information will be available soon.
Massage therapy is effective in reducing hand pain and increasing grip strength, according to a new study funded by Biotone and conducted by the Touch Research Institutes (TRI) at the University of Miami School of Medicine in Miami, Fla.
Arthritis is a systemic inflammatory disease, frequently located in the small joints of the hands. It affects the active, working-age population as well as the elderly, causing pain, activity limitations, and a lower quality of life. Many daily activities, for example, require considerable hand strength, such as opening doors, opening jar lids, lifting and carrying items. Hand strength in patients with arthritis is 75 percent lower than in healthy patients.
“While massage therapy has decreased pain in several pain syndromes, including fibromyalgia, lower back pain and migraine, this is the first report of pain reduction in hand arthritis following massage therapy,” said Dr. Tiffany Field, TRI director. “Up to now, many other interventions to alleviate hand pain have been tried -- medications, physical therapy and various forms of exercise. The results of this study are very encouraging for the application of massage therapy as a complementary alternative treatment for hand arthritis.”
Under the study, 22 adults ranging in age from 20 to 65 with wrist/hand arthritis were randomly assigned to a massage therapy or a standard treatment control group. The massage therapy group received massage on the affected wrist/hand once a week for a four-week period and also conducted self-massage on the wrist/hand at home daily. Biotone Polar Lotion was used in the massage therapy. The standard treatment control group did not receive massage therapy during the study.
The massage therapy group had lower anxiety and depressed mood scores after the first and last sessions, and by the end of the study reported less pain and greater grip strength. The massage therapy group showed greater improvement than the standard treatment control group on all of these measures across the study period.
“Biotone continues to fund research regarding the different effects of massage therapy on consumer's health and well being," said Jean Shea, Biotone founder and CEO. “The arthritis, breast cancer and back pain studies we funded all have shown positive results that are very encouraging. Our research studies, in addition to the many others being conducted worldwide, provide increased awareness and acceptance of massage therapy as an effective complementary alternative treatment."
Biotone is supporting two research projects through the Massage Therapy Foundation for 2006. The research studies involve therapeutic massage for pediatric burn survivors and the effects of five minute foot massages on pediatric Intensive Care Unit patients. More information will be available soon.
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