FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

“Due to its prevalence, osteoporosis is a serious concern to public health,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

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FDA Approves a Cellular Immunotherapy for Men With Advanced Prostate Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.


Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient's own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient's immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient's own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

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FDA to Address Challenges of Using Complex Medical Devices in the Home

/PRNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.

Hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators are among the medical products that have migrated to the home in recent years. And more hospital patients of all ages are being discharged to continue their medical treatment at home.

"Using complex medical devices at home carries unique challenges," said Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health. "Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product's functioning."

According to an FDA white paper, the initiative will develop guidance for manufacturers who intend to market a device for home use, provide for postmarket surveillance, and put in place other measures to encourage safe use of these products. In addition, the FDA is developing educational materials on home use of medical devices.

"The FDA's Home Use Initiative will help address the potential challenges, providing greater protection and awareness for patients who are being cared for in the home," Shuren said.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products. The new home use guidance document that FDA intends to develop will:

-- make recommendations for actions manufacturers should take to support
premarket approval or clearance of these devices, including device
testing with at-home caregivers and patients in a non-clinical
setting,
-- define circumstances under which the FDA may exercise its authority to
require that certain devices cleared for marketing carry a statement
in the labeling that the device has not been cleared for use in the
home,
-- recommend postmarket surveillance to identify and address adverse
events that may occur in the home.


In addition to developing the guidance document, the FDA will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.

The Home Use Initiative also contains measures for enhanced postmarket surveillance through HomeNet, a subnetwork of the FDA's Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 health care facilities nationwide.

Understanding issues experienced by home users will help the FDA develop appropriate actions to address those issues in the future. It may also identify cases in which devices intended solely for use in a health care facility are being used at home. The FDA already has collected information on safety concerns related to home hemodialysis and is now collecting similar information on the use of some wound therapy devices.

The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe use practices.

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Arthritis Impacts African-Americans and Hispanics More than Whites

/PRNewswire/ -- Arthritis causes more pain and limitations for African-Americans and Hispanics than for whites, according to a study released today by the Centers for Disease Control and Prevention.

African-Americans were 17 percent less likely to report having arthritis than whites, and Hispanics were 46 percent less likely to report the condition than whites, the study said. However, African-Americans and Hispanics with arthritis were almost twice as likely to report severe joint pain and work limitations attributed to their arthritis when compared to whites, it said.

The study, "Difference in the Prevalence and Impact of Arthritis among Racial / Ethnic Groups," was published in the journal Preventing Chronic Disease.

Arthritis is the leading cause of disability in the United States, affecting 1 in 5 adults. It interferes with work and other daily activities and can complicate the management of other chronic diseases. Arthritis encompasses more than 100 diseases and conditions that affect joints and other connective tissue.

The reason for the racial and ethnic differences, while unknown, may result from a lack of access to health care, language barriers and cultural differences, the report says.

"We must address these stark differences in arthritis impact by using what we know,'' said Jennifer Hootman, an epidemiologist for the CDC National Center for Chronic Disease Prevention and Health Promotion and co-author of the report. "We can educate those with arthritis about increasing physical activity and self-management and reducing obesity, especially those in groups bearing a disproportionate burden from arthritis."

The data, collected from the CDC National Health Interview Survey, are the first to estimate the national prevalence of arthritis and assess its impact among smaller racial and ethnic groups that are usually grouped together when reporting health statistics.

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Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available

/PRNewswire/ -- The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available.

The affected products and their phase out schedule include:

Last Date to be
                         manufactured, sold or
  Inhaler Medication     dispensed in U.S.      Manufacturer
  Tilade Inhaler
   (nedocromil)         June 14, 2010           King Pharmaceuticals
  Alupent Inhalation
   Aerosol                                       Boehringer Ingelheim
   (metaproterenol)     June 14, 2010            Pharmaceuticals
  Azmacort Inhalation
   Aerosol
   (triamcinolone)      Dec. 31, 2010           Abbott Laboratories
  Intal Inhaler
   (cromolyn)           Dec. 31, 2010           King Pharmaceuticals
  Aerobid Inhaler
   System
   (flunisolide)        June 30, 2011           Forest Laboratories
  Combivent Inhalation
   Aerosol (albuterol
   and ipratropium in                            Boehringer Ingelheim
   combination)         Dec. 31, 2013            Pharmaceuticals
  Maxair Autohaler                               Graceway
   (pirbuterol)         Dec. 31, 2013            Pharmaceuticals

Patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

CFCs are harmful because they deplete the ozone layer miles above the Earth that absorb some of the sun's harmful ultraviolet rays. The United States has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs in the United States as of Jan. 1, 1996, except for certain limited uses, such as MDIs.

"During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA's Center for Drug Evaluation and Research. "We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them."

The CFC phase out is part of an international agreement to ban substances that deplete the Earth's ozone layer. The Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act aim to protect the public health and the environment from the potentially negative effects of ozone depletion. Bans on products containing CFCs began in the late 1970s.

The decision to phase out the products is the latest in a series of decisions related to the removal of CFC inhaler products from the market as required by the Clean Air Act. The agency proposed to phase-out the seven remaining products in 2007 and reached a final decision after reviewing more than 4,000 public comments and information submitted as part of a public meeting.

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New Study Evaluates Effectiveness of Vitamins for the Treatment of Sun-Damaged Skin

/PRNewswire/ -- While everyone knows that getting an adequate daily dose of vitamins and minerals is important in maintaining one's overall health, many question whether or not the vitamins touted in skin care products work in reducing the signs of sun-damaged skin. Now, a new study reviews the currently published scientific literature to determine what evidence exists to support the use of vitamins in skin care products to slow or reverse the effects of sun damage.

In the report entitled, "Vitamins and photoaging: Do scientific data support their use?", published online in the Journal of the American Academy of Dermatology, dermatologist Jenny Kim, M.D., Ph.D., FAAD, associate professor in the division of dermatology, department of medicine, at the University of California, Los Angeles (UCLA), David Geffen School of Medicine in Los Angeles, presented results of a study that may support the use of certain vitamins in oral or topical formulations.

"It is well documented that ultraviolet (UV) radiation contributes to premature skin aging through the process of photoaging, and there is increasing evidence that the antioxidant properties of vitamins may contribute to the prevention and treatment of photoaging," said Dr. Kim. "In fact, numerous companies developing cosmeceuticals base their effectiveness claims on the fact that their formulations contain vitamins proven in laboratories to modify cellular processes thought to contribute to the appearance of photoaged skin. As dermatologists, we can help our patients navigate this maze of marketing claims by sharing scientific data on the known efficacy of vitamins in skin care products."

Based on a comprehensive review of the available published data on the role of vitamins in skin care products, Dr. Kim and her colleagues, Jamie Zussman, M.D., FAAD, and Jennifer Ahdout, M.D., found there is evidence to support the potential role of vitamins A, C, E, and B3 in modifying the photoaging process.

"While it's evident that these vitamins can play a role in fighting sun damage, the question still remains whether these properties are effective when delivered in skin care products," notes Dr Kim.

Vitamin A: Effective in treating a variety of skin conditions

The two most common forms of vitamin A studied for their role in protecting the skin from UV-induced damage are retinols and carotenoids. Retinol is found in foods such as liver, milk and eggs, and is the most biologically active form of the vitamin. Carotenoids are found in many fruits and vegetables, and have strong antioxidant capabilities.

While carotenoids are not shown to be beneficial in the treatment of photoaging, research suggests that they may play a role in photoprotection by preventing UV-induced collagen breakdown.

"Although the evidence available at this time is not strong enough to offer definitive support for the use of dietary carotenoids for photoprotection, a role for carotenoids as a supplement to photoprotective agents should not be discounted yet," said Dr. Kim. "We hope to see larger-scale clinical trials conducted to further explore the photoprotective effects of carotenoids."

Unlike carotenoids, there is vast evidence supporting the role of topical retinoids (the class of substances formed by retinol and its natural and synthetic derivatives) in treating photoaged skin. For example, prescription retinoid formulations have the most scientific data to support their use in this area.

Dr. Kim noted that both tretinoin cream (0.025% and 0.05%) and tazarotene cream (0.1%) are already FDA-approved for the treatment of fine wrinkles, skin roughness and mottled hyperpigmentation caused by aging and sun exposure. In addition, she added that studies of other retinoids have shown that a once-daily application of 0.1% isotretinoin cream for 36 weeks was effective in reducing fine wrinkles.

Retinoids also are found in over-the-counter cosmeceuticals, but there is less clinical evidence supporting their effectiveness in improving photoaged skin. "An important point to remember with retinoids is that we cannot assume that all retinoids are equal in their ability to fight photoaging," said Dr. Kim. "In over-the-counter products, retinol appears to be the most effective retinoid based on clinical studies completed to date. However, patients should consult their dermatologist before using any topical retinoid, as side effects can occur when used with other topical products. When properly instructed by a dermatologist, most patients can tolerate topical retinoids and benefit from their effect."

Dr. Kim added that unlike topical retinoids, there is minimal evidence supporting the use of oral retinoids in the treatment of photoaging.

Vitamin C: Possible skin care product value

Vitamin C, a water-soluble vitamin also known as ascorbic acid that is found in citrus fruits and dark green leafy vegetables, plays an essential role in the production of collagen and elastin. Because of its antioxidant properties, vitamin C may reverse the negative effects of UV radiation in the skin, but there are few clinically controlled studies to confirm this theory.

"An animal study examining the role of vitamin C in reversing sun damage found that when 5% ascorbate was applied two hours before UVB and UVA exposure, UVB-induced skin wrinkling was reduced," said Dr. Kim. "Some of the human clinical trials have shown similar favorable results when applying a daily dose of L-ascorbic acid treatment, but all of these studies involved small sample sizes."

In addition, Dr. Kim pointed out that one concern of adding vitamin C to cosmeceuticals is that vitamin C is unstable when used in formulations, and it is not known how much, if any, intact molecule remains when applied to the skin.

"This problem has been partially overcome by chemically modifying ascorbic acid," said Dr. Kim. "However, for the body to use the supplied ascorbic acid, it must convert it to L-ascorbic acid, and many of the stabilized, commercially available forms have not been examined to determine whether this conversion is possible. For that reason, the average consumer will not be able to determine if a cosmeceutical containing vitamin C will be effective."

Vitamin E: A primary antioxidant

Vitamin E, or tocopherol, is a fat-soluble vitamin, and its synthetic form is found in many over-the-counter products. Working as an antioxidant, vitamin E protects cell membranes and is thought to play an important role in skin aging because of its antioxidant properties. While topical vitamin E is available in a variety of products, there is no data which support claims that it improves skin wrinkling, discoloration and texture.

"Topical vitamin E has been studied in humans, as in mice, more as a protectant to be used before sun exposure than as an agent to be included in cosmeceuticals to reduce the signs of skin aging," said Dr. Kim. "Through research we have learned that UV exposure significantly decreases levels of cutaneous vitamin E, and vitamin C should be included in any formulation containing vitamin E because of the important role it plays in maintaining active vitamin E levels."

Research also has explored combining vitamins E and C as an oral supplement to provide sun protection. Multiple studies suggest that this combination therapy is beneficial for photoprotection. However, Dr. Kim noted that overzealous oral vitamin E supplements may be harmful, and two new studies also suggest that a high intake of vitamin E may be associated with an increased risk of basal cell carcinoma.

Vitamin B3: A possible treatment for photoaging

The B vitamins consist of eight different water-soluble vitamins that are found in a variety of foods. Vitamin B3 has been shown to reduce blood cholesterol and atherosclerosis (a condition in which fatty materials collect along artery walls), but now new insights are examining its role as an effective treatment for several skin conditions - from acne to photoaging.

Specifically, Dr. Kim noted that vitamin B3 has been found to increase collagen production in in vitro studies and to reduce skin hyperpigmentation (dark spots) in clinical studies.

"There has been one clinical trial conducted in Caucasian women in which 50 women applied 5% niacinamide (topical vitamin B3) to one side of their faces twice per day for 12 weeks, and these women experienced significant reductions in the appearance of hyperpigmented spots, redness, wrinkles, and yellowing, as well as improved skin elasticity," said Dr. Kim. "While initial studies show promise that topical vitamin B3 may prevent UV-induced skin aging, larger clinical trials are needed to confirm its role as a definitive treatment of photoaging."

Bottom Line: Maintain healthy lifestyle, healthy diet, practice sun protection

Dr. Kim added that it is important for everyone to get an adequate daily supply of vitamins to maintain a healthy lifestyle, and any insufficiencies may negatively impact the skin's overall appearance.

"Research has shown a potential role for various vitamins in reducing the damaging effects of sun exposure on the skin. Whether topical or oral formulations containing these vitamins have a protective effect is uncertain. Given the number, type and variability of preparations available, consumers should understand from our study that skin care products with vitamins may not provide clinically meaningful improvement," said Dr. Kim. "What is known is that proper sun protection is key to the prevention of photoaging and should be top of mind at all times."

For more information on improving the appearance of your skin, go to the "AgingSkinNet" section of www.SkinCarePhysicians.com, a Web site developed by dermatologists that provides patients with up-to-date information on the treatment and management of disorders of the skin, hair and nails.

Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.

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HHS, HUD Partner to Allow Rental Assistance to Support Inedpendent Living for Non-Elderly Persons with Disabilities

Thousands of Americans with disabilities will have housing assistance specifically targeted to meet their needs, Health and Human Services (HHS) Secretary Kathleen Sebelius and Housing and Urban Development (HUD) Secretary Shaun Donovan announced today.

As part of President Obama's Year of Community Living initiative, HHS and HUD collaborated to provide housing support for non-elderly persons with disabilities to live productive independent lives in their communities rather than in institutional settings.

HUD is offering approximately $40 million to public housing authorities across the country to fund approximately 5,300 Housing Choice Vouchers for non-elderly persons with disabilities, allowing them to live independently. HHS will use its network of state Medicaid agencies and local human service organizations to link eligible individuals and their families to local housing agencies who will administer voucher distribution.

"This number of vouchers to this community is a major milestone for HUD," said Donovan. "I am pleased that two federal agencies have combined efforts to give these individuals the independence they so desperately want and deserve."

"This commitment by HHS and HUD to directly link housing support to these individuals will be of immeasurable value not only to them, but to the communities in which they will be living," said Sebelius. "Individuals with disabilities have so much to contribute to the quality of life in our communities when given the freedom and opportunity to do so."

Of the 5,300 vouchers set aside as part of this program, up to1,000 will be specifically targeted for non-elderly individuals with disabilities currently living in institutions but who could move into the community with assistance (Category II). The remaining 4,300 (Category I) can be used for this purpose also, but are targeted for use by non-elderly individuals with disabilities and their families in the community to allow them to access affordable housing that adequately meets their needs.

In addition, HUD is encouraging housing authorities to establish a selection preference to make some, or all, of their Category I allocation available to individuals with disabilities and their families who, without housing assistance, are at risk of institutionalization. Housing authorities have 90 days to submit their applications to HUD. HUD expects to have funding awards ready late fall 2010.

"Many of these individuals are low-income and can not afford market rates for housing. For a number of Americans, these vouchers, along with Medicaid home and community-based services, are essential supports that make the President's vision for community living possible," Sebelius noted.

The vouchers will augment work already being done by the Centers for Medicare and Medicaid Services (CMS) through its Medicaid Money Follows the Person (MFP) grant program. Originally set to expire next year, the "Patient Protection and Affordable Care Act of 2010" extended the MFP program through 2016 with an additional appropriation of over $2 billion. The Act also cut to three months, from the previous six months, the amount of time a person must be in an institution to qualify for help making the transition to community life.

Now in its third year, the MFP program has made it possible for almost 6,000 people to live more independent lives by providing necessary supports and services in the community. Some 29 states and the District of Columbia have MFP programs.

The Year of Community Living is an outgrowth of a 1999 Supreme Court decision in Olmstead v. L.C., in which the court ruled that under the Americans with Disabilities Act (ADA) unnecessarily institutionalizing a person with a disability who, with proper support, can live in the community can amount to discrimination. In its ruling, the Court said that institutionalization severely limits the person's ability to interact with family and friends, to work and to make a life for him or herself.

As a result of the Olmstead ruling, HHS issued guidance to states on how to make their Medicaid programs more responsive to people living with disabilities who wish to reside in the least restrictive setting. Today's announcement is yet another step in HHS's 10-year effort to achieve that goal.

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HHS Secretary Kathleen Sebelius and Other Health Experts to Host Webchat on Health Insurance Reform and Seniors

U.S. Department of Health and Human Services Secretary Kathleen Sebelius and Assistant Secretary for the Administration on Aging Kathy Greenlee will host a webchat today, THURSDAY April 8, to
discuss the benefits of the new health reform law as it relates to America's seniors. Sebelius and Greenlee will highlight some of the immediate benefits of health reform for America's seniors before
answering pre-submitted questions from the public.

The chat is the second in a series of discussions that is designed to help Americans understand the benefits of the newly passed health insurance reform law.

Members of the public are encouraged to submit questions via email to HealthReform@hhs.gov. HHS officials will try to answer as many questions as possible during the web chat and post up questions and answers on the web site as well.

WHAT: Health Reform Weekly Webchat with HHS Secretary Kathleen Sebelius, Assistant Secretary for Aging Kathy Greenlee and Principal Deputy Administrator for the Centers for Medicare & Medicaid Services, Marilyn Tavenner

WHEN: Thursday April 8, 2010 at 1:00 p.m. EDT

WHERE: www.HealthReform.gov

The webchat will be available via satellite feed at the following coordinates:

SATELLITE:
G-19 04K Digital Only Slot B
Orbital Location: 97' West

Ku-Band
D/L: 11786.4Mhz Horizontal
FEC: 3/4
Symbol Rate: 6.111319 @ 204 packet = 8.448 Data Rate
4X3 Aspect Ratio


For more information on the new health reform law please visit www.healthreform.gov

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FDA Approves First Totally Implanted Hearing System

The U.S. Food and Drug Administration today announced the approval of the Esteem – an implanted hearing system used to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss.

Sensorineural hearing loss is usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections, or aging. The results are reductions in perception of sounds and in the ability to understand speech.

This differs from conductive hearing loss, which occurs when sound waves cannot transmit well through the outer or middle ear or both. Medical or surgical treatment can often restore hearing in people with a conductive hearing loss, which can be caused by earwax, fluid in the middle ear space, or a punctured eardrum.

The Esteem system consists of external testing and programming instruments and three implantable components: a sound processor, sensor, and driver. The sensor senses vibrations from the eardrum and middle ear bones and converts these mechanical vibrations into electrical signals, which are then sent to the sound processor, which amplifies and filters the signal to compensate for the individual patient’s hearing loss. The driver converts the enhanced electrical signal back to vibrations, which are then transmitted into the inner ear where they are perceived as sound.

“The approval of Esteem provides patients with an option to alleviate their hearing loss by using a device with no readily visible external components,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The system is designed to alleviate the effects of hearing loss in patients ages 18 years and older. Other criteria for the device include: stable bilateral sensorineural hearing loss, a normally functioning Eustachian tube, and normal middle ear anatomy. A patient’s ability to understand speech using Esteem should be similar to that of conventional hearing aids.

In a multicenter clinical study of Esteem versus pre-implant hearing aids, 93 percent of Esteem recipients scored equal to or better than their pre-implant hearing aids on a speech intelligibility test. Seven percent scored less than with their pre-implant hearing aids, and 56 percent scored better than with their pre-implant hearing aids.

Seven percent of participants experienced facial paralysis, and 42 percent experienced taste disturbance, both of which are results of the surgical procedure necessary to implant the device. The majority of these adverse events resolved during the one-year study period.

As a condition of FDA approval, Esteem manufacturer, Envoy Medical Corporation of St. Paul, Minn., must conduct two post-approval studies. In one study, Envoy must continue to follow-up on 61 subjects from the original study for five years to study safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation, and evaluate the effectiveness of Esteem five years after implantation.

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Vertebroplasty for Patients With Osteoporosis Provides Effective Pain Relief

/PRNewswire/ -- Patient selection is key for vertebroplasty--a minimally invasive treatment performed by interventional radiologists in individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy--to be effective and successful, according to a study of more than 1,500 persons who were followed over seven years. Additionally, collaboration between an interventional radiologist and other medical experts in treating a patient is imperative, say researchers at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

"Vertebroplasty puts lives and vertebrae back together," said Giovanni C. Anselmetti, M.D., interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy. Before treatment, many osteoporotic patients are in constant pain and cannot manage everyday activities. Vertebroplasty, a minimally invasive treatment performed by interventional radiologists under imaging guidance, stabilizes collapsed vertebrae with the injection of medical-grade bone cement into the spine. The treatment provides pain relief and improves one's quality of life--if given to appropriately selected candidates in whom conventional medical treatment has failed (such as analgesics or narcotic drugs that provide minimal or no pain release or doses that are intolerable), he further explained. "Our long-term follow-up confirmed this: pain relief and quality of life significantly improved with vertebroplasty," said Anselmetti.

Osteoporosis, the most common type of bone disease, is characterized by low bone mass and structural deterioration of the bone, resulting in an increased susceptibility to fractures. Osteoporosis affects 10 million Americans and is responsible for 700,000 vertebral fractures each year. Multiple vertebral fractures can result in chronic pain and disability, loss of independence, stooped posture and compression of the lungs and stomach.

"Vertebroplasty dramatically improves back pain within hours of the procedure, provides long-term pain relief and has a low complication rate, as demonstrated in multiple studies," said Anselmetti. Vertebroplasty provides pain relief from the complications of osteoporosis (vertebral fractures) but not the disease that caused it (osteoporosis), said Anselmetti. "For the best results, collaboration between physicians is mandatory. All osteoporotic patients need to be followed by an interventional radiologist, who determines which patients are appropriate candidates to receive vertebroplasty treatment, and an experienced medical expert (in this study, a rheumatologist) to ensure continued treatment for osteoporosis," he said.

Anselmetti illustrated a typical case: an 80-year-old Italian woman, who was diagnosed last year with two painful osteoporotic vertebral collapses, underwent medical treatment for osteoporosis (with the drug teriparatide) and was still in pain when she was prescribed an external brace. After there was evidence of two new fractures (verified by MR imaging), she received vertebroplasty, experiencing "complete pain regression, no need for the brace and a dramatic Lazarus-like ability to perform daily activities," he noted.

Researchers studied 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from back-pain for vertebral collapses (MRI confirmed) who underwent a clinical interview; their medical treatment, pain grade, quality of life and extent of vertebral fracture were reviewed. Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist. Because interventional radiologists use high-quality, image-guiding systems (such as digital flat-panel fluoroscopy with built-in rotational image acquisition), treatment time is decreased, making for a safer procedure, added Anselmetti.

In 1,494 patients (96.9 percent), the average pretreatment pain score on the 11-point visual analog scale was 8.2+/-1.8, and it dropped "significantly" to an average of 1.1+/-1.6 after vertebroplasty treatment, said Anselmetti. A patient's ability to manage everyday life--such as washing, dressing or standing--was measured by the commonly used Oswestry Disability Questionnaire, which was completed by patients before and after vertebroplasty. The ODQ scores changed from an average of 68.7+/-7.6 percent to 18.5+/-8.2 percent. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the VAS significantly dropping from 7.9+/-1.5 to 1.3+/-1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Anselmetti said that additional studies need to be performed, such as a large randomized trial comparing conventional medical treatment to medical treatment plus vertebroplasty. In Europe, this is difficult, as patients with chronic back pain for vertebral osteoporotic fractures prefer to be treated by vertebroplasty--and not randomized into a medical treatment-only group. "Patients who are in so much pain ask if they can be considered for vertebroplasty treatment," said the co-author of "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience."

More information about the Society of Interventional Radiology, interventional radiologists and vertebroplasty can be found online at www.SIRweb.org.

Abstract 16: "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience," G.C. Anselmetti, A. Manca, G. Chiara, G. Iussich and D. Regge, all at the Institute for Cancer Research and Treatment, Candiolo, Italy; and G. Isaia, University of Turin, Turin, Italy, SIR 35th Annual Scientific Meeting March 13-18, 2010, Tampa, Fla. This abstract can be found at www.SIRmeeting.org.

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A Better Genetic Test for Autism

/PRNewswire/ -- A large study from Children's Hospital Boston and the Boston-based Autism Consortium finds that a genetic test that samples the entire genome, known as chromosomal microarray analysis, has about three times the detection rate for genetic changes related to autism spectrum disorders (ASDs) than standard tests. Publishing in the April issue of Pediatrics (and online March 15), the authors urge that CMA become part of the first-line genetic work-up for ASDs.

Expectant parents who have family members with ASDs, as well as families who already have an affected child, often request genetic testing. However, there is still only limited knowledge about actual causative genes. The currently recommended tests (karyotyping to look for chromosomal abnormalities and testing for Fragile X, the single largest known genetic cause of ASDs) often come up negative. Chromosomal microarray analysis (CMA) is a genome-wide assay that examines the chromosomes for tiny, sub-microscopic deletions or duplications of DNA sequences, known as copy-number variants.

CMA offers about 100-fold greater resolution than standard karyotyping. However, since it is new, it is often considered a second-tier test. Depending on where a person lives, or what insurance they have, CMA may not be covered by health insurance. "Based on our findings, CMA should be considered as part of the initial clinical diagnostic evaluation of patients with ASDs," says Bai-Lin Wu, PhD, Director of Children's DNA Diagnostic Lab in the Department of Laboratory Medicine, which has offered CMA to families since 2006.

The research team, led by co-senior authors Wu (heading the Children's team), and David Miller, MD, PhD, of Children's Division of Genetics and Department of Laboratory Medicine (heading the Autism Consortium team), assessed the diagnostic value of CMA in the largest cohort to date - 933 patients with a clinical diagnosis of ASD (by DSM-IV-TR criteria) who received clinical genetic testing in 2006, 2007 and 2008.

Half were Children's patients who had their samples submitted to the hospital's DNA Diagnostic Laboratory, and the others were recruited through the Autism Consortium, a research and clinical collaboration of five Boston-area medical centers. Nearly half of the patients were diagnosed with autistic disorder, nearly half with PDD-NOS (pervasive developmental disorder - not otherwise specified) and about 3 percent with Asperger disorder. Ages ranged from 13 months to 22 years.

Testing included the two currently used tests (G-banded karyotype and fragile X), as well as CMA. When the researchers compared the tests' diagnostic yield, they found:

-- Karyotyping yielded abnormal results in 2.23 percent of patients
-- Fragile X testing was abnormal in 0.46 percent
-- CMA results were judged to be abnormal in 7.3 percent of patients when
the entire length of the chromosomes (the whole genome) was sampled.


Extrapolating from these results, the researchers estimate that without CMA, genetic diagnosis will be missed in at least 5 percent of ASD cases. CMA performed best in certain subgroups, such as girls with autistic disorder, and past studies indicate that it also has a higher yield in patients with intellectual disability (who constituted only 12 percent of this sample).

"CMA clearly detects more abnormalities than other genetic tests that have been the standard of care for many years," says Miller. "We're hoping this evidence will convince insurance companies to cover this testing universally."

In all, roughly 15 percent of people with autism have a known genetic cause. Establishing a clear genetic diagnosis helps families obtain early intervention and services for autism, and helps parents predict the possibility of having another child with autism.

In addition, by pinpointing bits of chromosomes that are deleted or duplicated, CMA can help researchers zero in on specific causative genes within that stretch of DNA. They can also begin to classify patients according to the type of deletion or duplication they have, and try to find specific treatment approaches for each sub-type of autism.

"Just in the last two years, a number of studies have revealed the clinical importance of ever smaller chromosome deletions and duplications found with advanced microarray technology," says Wu. "These new, highly-efficient tests can help in the evaluation or confirmation of autism spectrum disorders and other developmental disorders, leading to early diagnosis and intervention and a significantly improved developmental outcome."

Two known chromosome locations - on chromosome 16 (16p11.2) and chromosome 15 (15q13.2q13.3) accounted for 17 percent of abnormal CMA findings. Both chromosome abnormalities were initially linked with ASDs by Children's Hospital Boston and collaborators in The New England Journal of Medicine and the Journal of Medical Genetics, respectively, in 2008. Children's now offers specific tests targeting both of these "hot spots."

However, the researchers note that most copy-number changes were unique or identified in only a small number of patients, so their implications need further study. Many of them are presumed to be related to ASDs because they involve important genes, cover a large region of the chromosome, or because the child is the first person in that family to have the change.

"Some deletions and duplications are rare and specific to one individual or one family," says Miller. "Learning about them is going to be an evolving process. There won't be one single test that finds all genetic changes related to autism, until we completely understand the entire genome."

The paper's co-first authors were Autism Consortium members Yiping Shen, PhD, of Children's Department of Laboratory Medicine and the Center for Human Genetic Research at Massachusetts General Hospital, and Kira Dies, ScM, LGC, of the Family Research Network of the Autism Consortium and Children's Multi-Disciplinary Tuberous Sclerosis Program. A number of specialists from Children's Departments of Neurology, Developmental Medicine and Clinical Genetics and physicians from other medical centers in greater Boston were also authors on the study. The research was supported by the Nancy Lurie Marks Family Foundation, the Simons Foundation, Autism Speaks and the National Institutes of Health.

Families interested in scheduling an appointment at Children's may call the Developmental Medicine Center (617-355-7025) or the Department of Neurology (617-355-2711).

Citation: Shen Y; et al. Clinical genetic testing for patients with autism spectrum disorders. Pediatrics 2010 Apr; 125(4):e1-e17. (Published online March 15)

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New, National Amnesty International Report Finds Appalling U.S. Death Rate for Women Having Babies, Systemic Failures and Shocking Disparities in Maternal Health Care System; Georgia is 50th Among All States in Maternal Mortality

/PRNewswire/ -- In releasing a new report on maternal health nationwide, Amnesty International today revealed that flaws and shocking disparities in maternal health care that the government is ignoring lead to two to three women dying daily in the United States from pregnancy-related complications, with half of these deaths believed preventable, according to the Centers for Disease Control. A state-by-state examination shows that Georgia is 50th on a maternal mortality ranking, with 20.5 deaths per 100,000 live births.*

The new Amnesty International report, Deadly Delivery: The Maternal Health Care Crisis in the USA, also reveals that severe pregnancy-related complications that nearly cause death -- known as "near misses" -- are rising at an alarming rate, increasing by 25 percent since 1998; currently nearly 34,000 women annually experience a "near miss" during delivery. With a lifetime risk of maternal deaths that is greater than in 40 other countries, including virtually all of the industrialized countries, the United States has failed to reverse the two-decade upward trend in preventable maternal deaths, despite pledges to do so.

The report cited numerous causes for the crisis and offers lengthy recommendations on improving maternal health care.

Inadequate prenatal care is cited as a contributing factor in the crisis; women who do not get prenatal care are three to four times more likely to die than women who do. In Georgia, almost one in six women (15.8 percent) receive delayed or no prenatal care. The number rises to one in five women (21.9 percent) among women of color.

Obstacles to care are widespread: the most obvious being that across the United States nearly 13 million women of reproductive age (15 to 44), or one in five, have no health insurance. In Georgia nearly one in five women (19.7 percent) are uninsured; among women of color the number of uninsured climbs to 27.6 percent. The state's Medicaid eligibility level for working parents is also very low, $9,072. Lack of access to health care centers and providers is a problem nationwide, the report found; in Georgia 41 percent of women live in medically underserved areas.

"No issue can be more central to the health and well-being of our nation than maternal health care," said Jared Feuer, Southern Regional Director for Amnesty International USA. "The government should accept its duty and its moral obligation to address this inexcusable crisis by developing a comprehensive plan to ensure quality health care for all pregnant women. If the federal government can address steroid use in baseball, certainly lawmakers can address maternal health, which affects every family in the United States."

Maternal health is a human right for every woman in the United States, regardless of race or income. Yet, the United States lacks a systematic, robust government response to this critical problem. Amnesty International is urging President Obama to work with Health and Human Services Secretary Kathleen Sebelius to establish, and seek Congressional funding, for a single office responsible for ensuring that all women receive quality maternal health care. An Office of Maternal Health would lead government action to reduce the soaring pregnancy-related complications and maternal deaths nationwide.

Additionally, Amnesty International calls for vigorous enforcement of federal non-discrimination laws and an increase in support for Federally Qualified Health Centers by 2011 to expand the number of women who can access affordable maternal health care.

"This country's extraordinary record of medical advancement makes its haphazard approach to maternal care all the more scandalous and disgraceful," said Larry Cox, executive director of Amnesty International USA. "Mothers die not because the United States can't provide good care, but because it lacks the political will to make sure good care is available to all women."

Amnesty International's analysis shows that health care reform before Congress does not address the crisis of maternal health care.

"Reform is primarily focused on health care coverage and reducing health care costs, and even optimistic estimates predict that any proposal on the table will still leave millions without access to affordable care," said Rachel Ward, one of the authors of the Deadly Delivery report. "Furthermore, it does not address discrimination, systemic failures and government accountability documented in Amnesty International's report."

Rapid and comprehensive federal leadership is required, as the report found numerous systemic failures, including the following:

-- Burdensome bureaucratic procedures in Medicaid enrollment
substantially delay access to vital prenatal care for pregnant women
seeking government-funded care. Twenty-one states do not offer
"presumptive eligibility" which allows pregnant women to temporarily
access medical care while their permanent application for Medicaid is
pending. Women who do not receive any prenatal care are three to four
times more likely to die than women who do.
-- The number of deaths is significantly understated because there are no
federal requirements to report maternal deaths or complications and
data collection at the state level is insufficient.
-- Oversight and accountability is lacking. 29 states and the District of
Columbia have no maternal death review process at all.


Amnesty International is a Nobel Peace Prize-winning grassroots activist organization with more than 2.2 million supporters, activists and volunteers in more than 150 countries campaigning for human rights worldwide. The organization investigates and exposes abuses, educates and mobilizes the public, and works to protect people wherever justice, freedom, truth and dignity are denied.

For more information or to take action, please visit: www.amnestyusa.org/deadlydelivery

*National Women's Law Center, National Report Card on Women's Health, Maternal Mortality Rate Table; available at

http://hrc.nwlc.org/Status-Indicators/Key-Conditions/Maternal-Mortality-Ra te.aspx.

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CDC Study Finds U.S. Herpes Rates Remain High

/PRNewswire/ -- About 1 in 6 Americans (16.2 percent) between the ages of 14 and 49 is infected with herpes simplex virus type 2 (HSV-2), according to a national health survey released today by the Centers for Disease Control and Prevention. HSV-2 is a lifelong and incurable infection that can cause recurrent and painful genital sores.

The findings, presented at the 2010 National STD Prevention Conference, indicate that herpes remains one of the most common sexually transmitted diseases (STDs) in the United States.

The new estimate, for 2005-2008, comes from CDC's National Health and Nutrition Examination Survey (NHANES), a nationally representative survey of the U.S. household population that assesses a broad range of health issues.

The findings suggest relatively stable HSV-2 prevalence since CDC's last national estimate (17 percent for 1999-2004), because the slight decline in prevalence between the two time periods is not statistically significant.

The study finds that women and blacks were most likely to be infected. HSV-2 prevalence was nearly twice as high among women (20.9 percent) than men (11.5 percent), and was more than three times higher among blacks (39.2 percent) than whites (12.3 percent). The most affected group was black women, with a prevalence rate of 48 percent.

As with other STDs, biological factors may make women more susceptible to HSV-2 infection. Additionally, racial disparities in HSV-2 infection are likely perpetuated because of the higher prevalence of infection within African-American communities, placing African-Americans at greater risk of being exposed to herpes with any given sexual encounter.

"This study serves as a stark reminder that herpes remains a common and serious health threat in the United States. Everyone should be aware of the symptoms, risk factors, and steps that can be taken to prevent the spread of this lifelong and incurable infection," said Kevin Fenton, M.D., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. "We are particularly concerned about persistent high rates of herpes among African-Americans, which is likely contributing to disproportionate rates of HIV in the black community."

Research shows that people with herpes are two to three times more likely to acquire HIV, and that herpes can also make HIV-infected individuals more likely to transmit HIV to others. CDC estimates that over 80 percent of those with HSV-2 are unaware of their infection. Symptoms may be absent, mild, or mistaken for another condition. And people with HSV-2 can transmit the virus even when they have no visible sores or other symptoms.

"Many individuals are transmitting herpes to others without even knowing it," said John M. Douglas, Jr., M.D., director of CDC's Division of STD Prevention. "We can't afford to be complacent about this disease. It is important that persons with symptoms suggestive of herpes -- especially recurrent sores in the genital area -- seek clinical care to determine if these symptoms may be due to herpes and might benefit from treatment."

Combination of Prevention Approaches Needed to Reduce National Herpes Rates

Although HSV-2 infection is not curable, there are effective medications available to treat symptoms and prevent outbreaks. Those with known herpes infection should avoid sex when herpes symptoms or sores are present and understand that HSV-2 can still be transmitted when sores are not present. Effective strategies to reduce the risk of HSV-2 infection include abstaining from sexual contact, using condoms consistently and correctly, and limiting the number of sex partners.

CDC does not recommend HSV-2 screening for the general population. However, such testing may be useful for individuals who are unsure of their status and at high risk for the disease, including those with multiple sex partners, those who are HIV-positive, and gay and bisexual men.

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FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers

The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.

“Muscles affected by spasticity have increased stiffness and tightness, which may lead to pain, difficulties with hygiene and other activities of daily living, and may affect how a patient looks,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In clinical trials, treatment with Botox was found to be beneficial to patients with upper limb spasticity.”

Botox works by temporarily blocking the connections between nerves and muscles, resulting in a temporary paralysis of the spastic muscle.

Botox has a Boxed Warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening.

The most common adverse reactions reported by patients with upper limb spasticity were nausea, fatigue, bronchitis, muscle weakness, and pain in the arms.

Botox has not been shown to be safe and effective treatment for other upper limb muscles, spasticity in the legs, or for treatment of fixed contracture – a condition that affects range of motion. Treatment with Botox is not intended to substitute for physical therapy or other rehabilitative care.

Botox is manufactured by Allergan Inc. of Irvine, Calif.

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FDA Approves Name Change for Heartburn Drug Kapidex

The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.

Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex (bicalutamide) and Kadian (morphine sulfate), which have very different uses from Kapidex and from each other.

Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex, marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used to treat pain.

“The FDA is pleased to have worked with Takeda to take swift and responsible steps to change the name of this product in the interest of patient safety,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA evaluates new drug names before a product is approved to minimize confusion with existing drugs. Sometimes unexpected name confusions can occur once the product goes to market.

To improve this safety process, the FDA has issued a new guidance for industry titled Contents of a Complete Submission for the Evaluation of Proprietary Names. The guidance explains what information should be submitted to help in the evaluation of a proposed proprietary drug or biologic name, and to ensure compliance with other requirements for labeling and promotion.

These efforts are part of the agency’s Safe Use Initiative which was launched in November 2009. The goal of this initiative is to reduce preventable medical errors through collaboration with public and private institutions.

There will be no changes made to Kapidex other than its name. Health care professionals and other individuals responsible for ordering, stocking, and billing for the product should be aware that Dexilant will have a new National Drug Code (NDC) number associated with the product.

Individuals and health care professionals who have questions about the name change should contact Takeda at 877-TAKEDA-7.

Medication errors involving Dexilant or any other medications should be reported to the FDA’s MedWatch program online at http://www.fda.gov/medwatch1.

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Low Production of Serotonin in the Brainstem a Likely Cause for SIDS

/PRNewswire/ -- Taking the next step in more than 20 years of research, researchers at Children's Hospital Boston have linked sudden infant death syndrome (SIDS) with low production of serotonin in the brainstem, based on a comparison of brainstem samples from infants dying of SIDS compared to brainstems of infants dying from other, known causes.

The findings, published in the Feb. 3 issue of The Journal of the American Medical Association, may give a concrete approach to identifying babies at risk for SIDS, the leading cause of death for infants between 1 and 12 months old in the United States.

In the brainstem, serotonin helps regulate some of the body's involuntary actions, such as breathing, heart rate and blood pressure during sleep. The researchers, led by Children's neuropathologist Hannah Kinney, MD, believe that a low serotonin level impairs the function of the brainstem circuits that regulate these activities, putting a baby at risk for sudden death from stresses such as rebreathing carbon dioxide when sleeping in the face down position.

The future goal of this work is to devise a test to identify infants with a serotonin brainstem defect early, and to develop preventive treatments that would correct the serotonin deficiency.

In 2006, Kinney and colleagues showed that SIDS is associated with abnormalities in the number of cells and receptors related to serotonin in the brainstem, but it wasn't clear whether SIDS may be caused by overproduction or underproduction of the chemical.

In the new study, the team measured the levels of serotonin and tryptophan hydroxylase, the enzyme that helps make serotonin, in 35 infants dying from SIDS and two control groups (5 infants dying acutely from other causes, and 5 hospitalized infants with chronic hypoxia-ischemia (insufficient oxygen supply to tissues). Tissue samples from the brainstem were obtained from autopsies and provided by research partners at the San Diego County Medical Examiner's Office in California.

Compared with controls, the serotonin levels in the lower brainstem were 26 percent lower in the SIDS cases compared to controls, while the tryptophan hydroxylase levels were 22 percent lower. Levels of binding to serotonin receptors were also lower by more than 50 percent. The consistency and correlation of these findings with each other reinforce the idea that SIDS in the majority of cases is a disorder of serotonin the brainstem, the researchers say.

"The baby looks normal during the day; there's nothing that would tell you that baby is going to die of SIDS that night," says Kinney, who has studied SIDS for more than 20 years. "There's something about sleep that unmasks the defect, which we believe is in serotonin circuits: the baby experiences some kind of stress during sleep, such as rebreathing carbon dioxide in the face-down position or increased temperature from over-bundling, that cannot be compensated for by the defective brainstem circuits, and the baby then goes on to die."

In a normal baby rebreathing carbon dioxide, serotonin pathways in the brainstem would stir the baby awake long enough to turn its head, allowing it to breathe fresh air, Kinney adds. A baby with low serotonin levels in the brainstem may never stir.

SIDS has puzzled doctors and families for decades, but once the medical community recognized that a baby's position while sleeping affects the risk for SIDS, national awareness campaigns sprouted to persuade parents to place babies to sleep on their backs. However, such campaigns haven't completely solved the problem, prompting ongoing research to find a biological component to SIDS.

While this study provides strong evidence for a biological cause of SIDS, it also shows that other risk factors, such as sleeping on one's stomach, can aggravate the risk. Of the SIDS infants in the current study, 95 percent died with at least one risk factor, and 88 percent died with at least two.

The next step in this research is to find out what causes abnormally low serotonin levels in the first place. Genetic variations may be partly responsible, says neuroscientist David Paterson, PhD, in Kinney's lab, a contributing author of the paper. Kinney's lab is searching for such variations.

In the meantime, parents should remove unnecessary SIDS risk factors, Kinney says. During pregnancy, there is no safe level of alcohol a mother can drink and no safe level of smoking, both firsthand and secondhand. Until 12 months of age, babies should sleep on their backs in a crib with a firm mattress, and without toys, soft pillows, excessive blanketing or excessive clothing.

This study was supported by funds from the First Candle/SIDS Alliance, CJ Martin Overseas Fellowship, the CJ Murphy Foundation for Solving the Puzzle of SIDS, CJ Foundation for SIDS, the National Institute of Child Health and Development, and the Developmental Disabilities Research Center at Children's Hospital Boston.

Citation: Jhodie R. Duncan, PhD, David S. Paterson, PhD, Jill M. Hoffman, BS, David J. Mokler, PhD, Natalia S. Borenstein, MS, Richard A. Belliveau, BA, Henry F. Krous, MD, Elisabeth A. Haas, BA, Christina Stanley, MD, Eugene E. Nattie, MD, Felicia L. Trachtenberg, PhD, Hannah C. Kinney, MD. Brainstem serotonergic deficiency in Sudden Infant Death Syndrome. JAMA Feb. 3, 2010, Vol. 303, No. 5.

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New Pediatrics Report Urges Medical Community to Address Underlying Pathologies in Patients With Autism

/PRNewswire/ -- An article published today in the journal Pediatrics confirms what parents and advocacy organizations have been saying for years: many individuals with autism suffer from gastrointestinal disease that can contribute to behaviors and symptoms associated with autism.

Evaluation, Diagnosis, and Treatment of Gastrointestinal Disorders in Individuals With ASDs: A Consensus Report is the result of expert panel study and discussion led by Dr. Timothy Buie of the Harvard Medical School Department of Pediatrics. The panel's findings point out not only the existence of underlying GI disturbances that can manifest as behavioral problems, but also notes that such medical issues have often gone undiagnosed or been ignored in the past by physicians treating patients diagnosed with autism.

"We are finally getting mainstream acknowledgement that our kids are physically sick, and not the victims of some mysterious genetic behavioral disorder," commented Lori McIlwain, National Autism Association (NAA) board chair. "With one in 110 children now diagnosed with autism, we are in the midst of a national health emergency. Physicians must address the underlying medical conditions involved in this epidemic if they are to help us find answers and relief for our children."

The panel arrived at several conclusions regarding current clinical practice guidelines and made recommendations for future medical and research priorities. These include:

-- Current treatment guidelines do not routinely consider potential
medical problems
-- Problem behaviors including self-injury, aggression, irritability,
and sleep disturbance may be manifestations of abdominal pain
-- Behavioral treatment should not substitute for medical treatment
-- Gastrointestinal symptoms should be considered an urgent indication
for medical investigation
-- Immunologic dysfunction, inflammation, metabolic dysfunction, and
allergies are all potentially associated with autism
-- Research is needed to determine the role of abnormal GI permeability
in neuropsychiatric manifestations of autism
-- Greater awareness is needed among health care providers of the
atypical manifestations of GI disorders
-- Awareness of unrecognized medical conditions in autism must become a
priority of professional societies including the American Academy of
Pediatrics
-- Diagnostics should be performed to accurately identify co-morbid
allergic disease
-- Research is needed to determine the role of immune dysfunction in
autism


"This is definitely a step in the right direction," said Ms. McIlwain. "Our kids need and deserve clinical investigation and treatment for the underlying medical conditions from which they suffer."

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St. John's Wort Not Helpful Treatment for Irritable Bowel Syndrome, Mayo Clinic Researchers Say

A Mayo Clinic research study published in the January issue of The American Journal of Gastroenterology finds that St. John's wort is not an effective treatment for irritable bowel syndrome (IBS). While antidepressants are frequently used to treat IBS, to date, no study has examined the success of using the herbal supplement St. John's wort in treating IBS.

"Our study investigated if herbal antidepressants such as St. John's wort could benefit irritable bowel disease patients," says Yuri Saito, M.D., M.P.H., a gastroenterologist and lead physician scientist on the study. "Several of the chemical neurotransmitters that are in the brain are also in the colon. Therefore, it's been thought that antidepressants may affect sensation in the colon in a similar way to how they affect sensation in the brain. Our goal was to evaluate the usefulness of St John's wort in treating IBS."

In this placebo-controlled trial, 70 participants with IBS were randomized where half the patients received St. John's wort and the other half received a placebo for three months. In all, 86 percent of the participants were women, and the median age was 42 years. After three months of observing symptoms such as stomach pain, diarrhea, constipation and bloating, Mayo researchers found that the placebo group had a better response than the group taking the herbal supplement, St. John's wort.

"Because people tend to struggle with IBS for several years, patients are really looking for inexpensive, over-the-counter treatments such as St. John's wort," says Dr. Saito. "Unfortunately, our study showed that St. John's wort was not successful in helping IBS patients."

St. John's wort is an herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes. Research has shown it to be as effective as conventional, prescription anti-depressants in treating mild to moderate depression.

"The challenge with IBS is that there is no cure, no one treatment tends to be wholly effective and some treatments come with significant side effects," explains Dr. Saito. "However, well-designed studies of herbal supplements are important so that physicians and patients can make informed decisions about which supplements to recommend or try. Studies of alternative treatments are generally lacking and patients are forced to use a "trial and error" approach to over-the-counter treatments for their IBS."

IBS is a common disorder that affects the colon and commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. Approximately 58 million people struggle with IBS, mostly women.

Each year, Mayo Clinic physicians treat thousands of people with IBS. Read more information on treatment for irritable bowel syndrome at Mayo Clinic.

Mayo Clinic's Division of Gastroenterology and Hepatology has been ranked #1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 20 years ago.

Other members of the Mayo Clinic research team included Enrique Rey, M.D.; Ann Almazar-Elder; W. Scott Harmsen; Alan Zinsmeister, Ph.D.; G. Richard Locke , M.D.; and Nicholas Talley, M.D., Ph.D.
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Park Springs to Expand Health Care Center at Retirement Community

Cobblestone to add two memory care rooms, 18 skilled nursing rooms, two prep kitchens

Park Springs, the Southeast’s premier continuing care retirement community announces that it is renovating Cobblestone, the community’s health care center, expanding the facility by 12 rooms. The expansion will include two phases of construction. Phase one is slated to begin in early January, while phase two is scheduled to begin in mid-February.

Renovations during phase one construction will include adjusting eight assisted living suites into 14 memory care suites. A new memory care dining area with a new warming and preparation kitchen will also be added. A new wandering control system is also planned to increase Members safety. Updated finishes in the new common area will also occur at this time.

Phase two will consist of renovating 12 memory suites into 18 skilled nursing rooms. Construction will also include the addition of a new preparation kitchen as well as upgrades to the existing skilled nursing preparation kitchen. Renovations to the common areas, a new skilled family area, and offices for the community’s physician and assistant director of nursing will also be added at this time.

“We are excited about expanding Cobblestone,” said Joan Carlson, Park Springs’ vice president of quality, innovation and culture. “We currently offer the highest quality services, medical care, nursing and rehabilitative care in a residential environment in the Southeast and our expansion will allow us to increase the level of care we provide. It will also allow us to provide outside short term admission to our Medicare skilled unit.”

Cobblestone’s Resident Centered model provides Members flexibility in their daily activities embracing individuality while focusing on all aspects of wellness. Staffing ratios are approximately two times greater than the state average. A full time doctor trained as a geriatrician whose sole responsibility is the health of our Members is employed on site. A clinic staffed by a full time Licensed Nurse Practitioner performs routine check ups, tests and lab work. The community doctor, clinic and skilled care are all Medicare certified. Home care services are provided by trained staff employed directly by the Park Springs and are licensed by the state, bonded and insured only after undergoing a strict screening process.

About Park Springs
The Southeast's premier CCRC, Park Springs enhances life for active seniors by providing independent residences alongside extensive amenities and on-site wellness and private health care facilities. The 398-home campus-style community is situated on 54 acres surrounded by Stone Mountain Park. A 64-suite health center provides assisted living, skilled nursing and dementia/Alzheimer's care. The campus style community boasts a 50,000 square foot Clubhouse serving meals in four themed dining rooms daily and a 12,000 square foot fitness center with an indoor swimming pool. The Seniors Housing Council of the National Association of Home Builders named Park Springs a Platinum winner. Park Springs is developed by Isakson Living and managed by Life Care Services LLC (LCS), a leader in senior living communities. LCS today serves more than 23,000 residents daily in over 80 communities nationwide. For more information on Park Springs, call 678-684-3300 or visit www.parkspringscommunities.com.
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UGA Study finds significantly worse outcomes in cancer patients with cognitive impairment

A new study published by researchers from the University of Georgia and the Moffitt Cancer Center in Tampa, Fla., has found that cancer patients with dementia have a dramatically lower survival rate than patients with cancer alone, even after controlling for factors such as age, tumor type and tumor stage.

But the study, published in the early online edition of the journal Critical Reviews in Oncology/Hematology, also argues that a diagnosis of dementia shouldn’t discourage the use of cancer screenings and appropriate cancer treatments.

“As the population ages and as treatments improve, we’re going to see more patients with both dementia and cancer,” said lead author Claire Robb, assistant professor in the UGA College of Public Health. “And right now there are no guidelines for oncologists as to how to treat these patients.”

Robb and her co-authors in the Senior Adult Oncology Program at Moffitt compared the outcomes of 86 cancer patients with cognitive impairment to a control group of 172 patients with cancer alone. They found that cancer patients with dementia survived an average of four fewer years.

Robb, who is also a researcher in the UGA Cancer Center, said that the reason for the disparity is unclear. She notes that the patients in both groups received similar treatment and that the survival gap persists even after controlling for age, tumor type and tumor stage.

But Robb pointed out that within the cognitively impaired group, there was a dramatic difference in survival time between those with mild cognitive impairment and those with moderate to severe impairment. People with mild cognitive impairment often have problems with thinking and memory yet can still live independently; those with moderate to severe dementia forget details about current events, lose awareness and have difficulty with basic tasks such as preparing meals or choosing proper clothing. The researchers found that while patients with moderate to severe dementia had an average survival time of eight months, those with mild dementia had an average survival time of nearly four and a half years.

“Some people would argue against treating patients with mild cognitive impairment because they’re going to have a shorter survival,” Robb said. “But, you know, 53 months—almost 4 and a half years—is a pretty significant amount of time to live.”

The patients in the UGA/Moffitt study generally received the same treatment regardless of cognitive status, but other studies have found that patients with dementia often receive fewer cancer screenings and undergo less aggressive treatment. One study found that physicians were significantly less likely to recommend a mammogram for a woman with dementia than without, while another found that patients with dementia were twice as likely to have colon cancer reported only after death. Another study of breast cancer patients found that those with dementia were 52 percent less likely to have the tumor removed surgically, 41 percent less likely to undergo radiation therapy, 39 percent less likely to undergo chemotherapy and nearly three times more likely to receive no treatment.

“The fact that cognitively impaired patients seen in our Senior Adult Oncology Program received treatments similar to unimpaired patients while epidemiologic data show a marked difference in treatment provides food for thought,” said study co-author Dr. Martine Extermann, associate faculty member at Moffitt. “Although this might reflect a referral bias in which those who volunteered to participate in the study are different from the general population, it might also indicate that such patients benefit from a specialized evaluation and management in a geriatric oncology program.”

Robb emphasized that she does not advocate overly aggressive treatment for patients who are in the late stages of dementia, but urges the creation of guidelines to help ensure that cognitively impaired cancer patients receive appropriate treatment.

“People have thought about the impact of the aging population on rates of cancer and dementia, but not much attention has been paid to what happens when the diseases coincide,” Robb said. “We’re going to be seeing more cases like these, and, if anything, I hope our research raises awareness of this situation.”

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