Monday, June 30, 2008

Drinking More Water Can Help Stave Off Arthritis

/24-7PressRelease/ - It is vital for all age groups to drink enough water as it can help ward off arthritis and other chronic conditions, states The Arthritic Association.

Baroness Greengross, founder of the charity Action on Elder Abuse, has this week called for a set of minimum standards on hydration across the UK. However, it's not just the elderly who should drink more water. According to arthritis pioneer Charles de Coti-Marsh, we could all stay a lot healthier for longer if we looked after our gut, and staying hydrated is the first step.

Nutritional Therapist Elizabeth Hartland explains: "fany people will have heard about the benefits of healthy bacteria and the pro-biotic drinks you can now buy, but symptoms of an unhealthy digestive system, such as constipation, are less talked about. Charles de Coti-Marsh believed that a constipated state creates toxins which stay in the bowel, enter the blood stream and poison the body, the long term effects of which can be diseases such as arthritis. Drinking plenty of water can help avoid constipation."

Saturday, June 28, 2008

Chambliss, Isakson Praise Administration’s Decision to Delay Implementation of Medicare Cuts

U.S. Senators Saxby Chambliss, R-Ga., and Johnny Isakson, R-Ga., today praised the Administration’s decision to delay the implementation of the 10.6% cut to physicians' Medicare reimbursement until July 15, 2008 to avoid any disruption in the payment of physician and non-physician practitioner services beginning on July 1.

“It’s unfortunate that the Democratic Majority found a way to extend authorization for the Federal Aviation Administration, but given the chance to extend the current Medicare fee levels, they objected twice,” said Chambliss. “Doctors and seniors deserve a serious and responsible effort that addresses the impending fee cut without playing politics and creating a major expansion of entitlement spending. I will continue to work to provide doctors the relief they deserve and seniors the benefits they deserve.”

"I am very pleased the Administration is giving Congress more time to work out reasonable legislation to eliminate this 10 percent cut in Medicare payments to doctors. I will do everything I can to see to it that the Senate quickly passes a bill that helps Georgia doctors and that helps Georgia Medicare beneficiaries, especially our seniors and those who live in rural areas," Isakson said.

The Centers for Medicare and Medicaid Services (CMS) plans to instruct its contractors to not process any physician and non-physician practitioner claims for the first 10 business days of July. By holding claims for health care services that are delivered on or after July 1, CMS will not be making any payments on the 10.6 percent reduction until July 15, at the earliest.

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Gingrey Announces Temporary Halt to Medicare Reimbursement Cuts

U.S. Congressman Phil Gingrey, MD (R-GA) is pleased to announce that despite the Senate's failure to pass House-approved legislation to prevent a 10.6% cut to physicians' Medicare reimbursement, the Centers for Medicare and Medicaid Services (CMS) will effectively delay the scheduled cuts until at least July 15th—giving Congress time to address these cuts after the July 4th recess.

"This was an extraordinary but much-needed step to ensure that there is no disruption in the delivery and payment of physician services to Medicare patients,” said Gingrey. “Many refer to preventing these cuts as a ‘Doc Fix,’ but the reality is that if these cuts are not stopped, Medicare patients will be hurt the worst because they won't be able to find doctors who can afford to treat them. Congress had an obligation to fix this problem before leaving town for a weeklong recess, but they did not. Now, the Administration has given doctors and patients a reprieve from Congress’s failure to act. I hope that the Democratic Leadership will make the most of this opportunity they've been given and will work with Republicans to pass a Medicare reimbursement bill that will serve both our patients and our physicians."

Earlier this week, Congressman Gingrey voted for a bill to prevent the automatic 10.6% cut to physician reimbursement which passed the House. Though the legislation failed in the Senate, the Democratic leadership chose to adjourn the House of Representatives for the Fourth of July recess with no announced plans to reconvene. In response to inaction by Congress, CMS announced it will instruct contractors to not process any physician and non-physician practitioner claims for the first 10 business days of July, in accordance with existing law. This delay should give Congress additional time to enact legislation to prevent these cuts on a more permanent basis.

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Friday, June 27, 2008

Enerceutical Mediated Activation of the Alternative Cellular Energy (ACE) Pathway: A Clinical Trial Open to Qualified Parents of Autistic Children

24-7PressRelease/ -A natural therapy that activates the alternative cellular energy (ACE) pathway has been developed by the Institute of Progressive Medicine and is available for extended clinical studies in patients with various illnesses, including autism. Qualified parents of autistic children are being offered the opportunity to participate in these studies by acting as clinical investigators within the Institute of Progressive Medicine.

According to Dr. W. John Martin, MD, PhD. founder of the Institute of Progressive Medicine, the increasing incidence of autism is attributed to a relatively silent epidemic of an infectious disease process affecting adults that, in pregnant women, can cause brain damage of the fetus leading to the subsequent development of autism. He firmly believes the infectious agents are "stealth adapted" viruses that lack the antigenic components normally targeted by the cellular immune system.

"There has been an over emphasis on some of potential triggering factors of an autism breakdown," stated Dr. Martin, "rather than pursuing the fundamental cause of autism; seeking a truly effective therapy ;and most importantly, trying to prevent autism from developing in a susceptible, stealth adapted virus infected child."

The current treatment protocol is predicated upon the underlying postulate that autism is primarily caused a congenitally acquired, persisting, non-inflammatory viral infection that can not be effectively controlled by the immune system. Dr. Martin has proposed and has now proven that the body has an auxiliary defense mechanism beyond the immune system, which can suppress the cell damaging effects of viruses, including those that are stealth adapted. This protection can be increased by activating the ACE pathway using products termed enerceuticals. Some of these products work well if placed against the body and illuminated with an ultraviolet-A light.

The autism related studies using a light stimulated enerceutical medical device are being coordinated, in part, by Mr. BJ McKelvie, the co-producer of the autism anthem song "I'm in Here." "We have begun to see remarkable improvements in the treated children" commented Mr. McKelvie. "It is time to move forward with much more extensive clinical testing and for this we need parent participation. With a well coordinated effort, we can potentially achieve at least a 50% improvement in the intellectual and social functioning of children labeled as being autistic. This has occurred with my own son immediately after beginning the therapy."

While still investigational, the studies also hold promise as a potential approach to preventing autism from occurring in children born to mothers presumptively infected with a stealth adapted virus. "Maintaining an active ACE pathway during the first few years of life may help virus infected infants resist some of the suspected triggers of an autistic breakdown in interpersonal communication" commented Dr. Martin. "

A major challenge for public health authorities is to stop denying the existence of stealth adapted viruses, some of which clearly originated from African green monkey simian cytomegalovirus (SCMV) contamination of earlier batches of live polio virus vaccines." More information on this topic is available at www.s3support.com or my sending an e-mail to s3support@mail.com Parent enrollment procedures for the autism study can be viewed at the web site www.iminhere.ca or obtained by contacting Mr. BJ McKelvie via e-mail to bj@iminhere.ca

Respiratory Illness, Dog Bites Among Top Concerns For Travelers to China Study Provides Insight to Help Olympics Travelers Prepare for Trip

Beijing-bound Olympic travelers should worry less about exotic diseases, and instead focus on preventing more mundane health problems like respiratory illness and dog bites. A new study by experts at the Centers for Disease Control and Prevention and the GeoSentinel Surveillance
Network found that, during the past 10 years, dog bites were actually one of the more common health problems travelers face when visiting China. Other common ailments were respiratory infections, skin problems, injuries, and diarrhea.

With an estimated 600,000 foreign visitors and athletes, and as many as 2 million Chinese attendees, expected at the 2008 Olympic Games in Beijing in August, the study provides key information that can help people plan their visits and protect their health.

The paper, published online June 26, 2008, in the American Journal of Tropical Medicine and Hygiene, used 1998-2007 data gathered by the GeoSentinel Surveillance Network and analyzed by GeoSentinel and CDC experts to assess illnesses among the 2,500 travelers to China that were in the database. The GeoSentinel Network was founded by the CDC and the International Society of Travel Medicine and is made up of 41 travel medicine clinics worldwide that provide traveler care and track travel-related health data.

"Many international travelers worry about exotic diseases. They probably don't think about injuries or dog bites, but the study found that travelers to China sought treatment for these ailments more often," said Dr. Nina Marano, chief of the CDC's Travelers' Health and Animal Importation Branch. "Travelers need to be cautious about dog bites, as China has the second highest rate of human rabies cases in the world."

Respiratory illnesses, such as asthma and bronchitis, were the most common diagnoses for travelers seeking medical care while in China, and the primary cause of hospitalization for travelers in China. Acute diarrhea and dog bites were the most frequent ailments for travelers receiving post-travel medical care. Travelers also complained of injuries, like sprains and strains. Rates of tropical and parasitic disease were low: there were no reported cases of malaria or dengue fever among travelers in this study

"We hope travelers take this information and use it to prepare themselves for a healthy trip," said Dr. Marano. "Using common sense while in Beijing can also help keep you healthy. Wash your hands, watch your step, and don't pet stray dogs."

Travel health experts at CDC say that travelers can help reduce their risk of becoming ill or injured by taking the following precautions:

* Visit a travel medicine clinic four to six weeks prior to leaving to get travel advice.
* Ensure all vaccinations are up-to-date.
* Wash hands or use hand sanitizers frequently to help prevent the spread of respiratory and diarrheal illness.
* Avoid all animals while in China. If bitten, wash all bite wounds promptly and seek reliable medical care immediately.
* Wear comfortable walking shoes and pay special attention when crossing the street and boarding public transportation to minimize injury risk.
* Eat only fully cooked food that is served hot or fruits and vegetables you can wash and peel yourself to decrease the risk of diarrhea.

For more CDC recommendations for Olympic travelers, athletes and health-care providers, please visit http://wwwn.cdc.gov/travel/contentOlympics2008.aspx. For general
recommendations for travel to China, see http://wwwn.cdc.gov/travel/destinationChina.aspx.

Thursday, June 26, 2008

The Spine Institute of Louisiana is Selected to Implant an Investigational Device for Patients With Lumbar Spinal Stenosis

BUSINESS WIRE--Most patients facing surgery to correct a painful spinal condition are usually a bit apprehensive. Not so for 70-year-old Marveen Boone of Chase, Louisiana, who will become the first patient in the United States to surgically receive a new investigational device. The VertiFlex® Superion Interspinous Spacer is a small spacing device for lumbar spinal stenosis (LSS). LSS is a common and debilitating problem for people over age 50.

Boones surgery will be performed at the Spine Institute of Louisiana in Shreveport on Thursday, June 26, 2008. Spine surgeon, Pierce D. Nunley, M.D., will be the first surgeon in the United States to implant the new device in a research study. Dr. Nunley states: The instrumentation developed by VertiFlex® allows patients only a small scar and a quicker recovery. It integrates a minimally invasive technique that seeks to preserve all the normal anatomical structures of the spine. This is a good option for patients that would potentially be candidates for traditional fusion a more invasive procedure.

The Superion device is intended to correct LSS by opening the space in the spinal column that has gradually narrowed over time; resulting in pain and numbness from pressure on the spinal cord and nerve roots. The Superion device is implanted through a minimal incision that does not require general anesthesia. The out-patient procedure can be completed in as short as 20 minutes per level.

Compared with traditional fusion procedures, in which patients typically undergo hours of surgery, with extended hospital stays and lengthy rehabilitations, this device hopes to offer patients a much less invasive option, briefer hospital stay and a rapid recovery time. Boone says she cant believe her luck in being the first patient in the U.S. to receive this revolutionary new device here in Shreveport. I am so thankful to have this done without a big procedure. This one is so simple.

The Superion Interspinous Spacer is a titanium metal implant that is delivered through a small 12-15 millimeter incision in the patients back. A small delivery tube is placed through the incision and the device is then opened underneath the patients skin. As the implant is opened the wings embrace the spinous processes of the lower and upper level vertebra of the affected level. Once the device has been opened the delivery tube is removed and the incision is closed.

Superion is available only through this clinical trial at selected sites in the U.S., including the Spine Institute of Louisiana, says Medical Research Director Ajay Jawahar, M.D. He adds, This implant procedure may be a solution for elderly patients who are suffering with LSS, and have been reluctant to have surgery to correct it.

Earl Fender, President and Chief Executive Officer for VertiFlex®, stated: This is a significant milestone for VertiFlex®. The Superion Interspinous Spacer may be a contribution to treating an aging population suffering from spinal stenosis. VertiFlex® looks forward to demonstrating clinical success in the trial so that Superion can soon be offered to the general public.

Superion has already had considerable success in Europe. To date hundreds of Superion devices have been implanted in eight countries by over 30 surgeons.

Wednesday, June 25, 2008

UGA Research May Lead to Safer, More Effective Gene Therapy

The potential of gene therapy has long been hampered by the risks associated with using viruses as vectors to deliver healthy genes, but a new University of Georgia study helps bring scientists closer to a safe and efficient gene delivery method that doesn’t involve viruses.

Assistant professor of chemistry Yan Geng and her colleagues in the UGA Franklin College of Arts and Sciences have created a novel synthetic gene vector that packages DNA into well-defined nanostructures that allow it to efficiently deliver genes without triggering immune responses. The study, primarily carried out by doctoral student Jennifer Haley, appears in the June issue of the journal Molecular BioSystems and also may have implications for cancer treatment and vaccine development.

“We’ve developed a very versatile approach to creating synthetic gene delivery vectors,” said Geng, a Georgia Cancer Coalition Distinguished Scholar and a researcher in the UGA Cancer Center. “Our approach is relatively simple – using simple chemical reactions to create a new class of packaging molecules that wrap up genes on their own – and has the potential to be very useful in real-world, clinical applications.”

Gene therapy involves replacing abnormal, disease-causing genes with normal genes. To do this, genetically modified viruses often are used. The viruses do a remarkable job of inserting the new genes into hosts, Geng said, but they’re inherently dangerous. So while the use of viruses as gene delivery vectors has been efficient, it also has led to unexpected and tragic complications, some of which were fatal. Synthetic vectors, which use synthetic molecules to package genes, are generally safer than viral vectors, Geng said. The downside is that they’re not nearly as efficient. For millions of years, viruses have evolved into a small size, a rich variety of shapes – spherical, disk-like, and sometimes long filaments, and sophisticated mechanisms to facilitate the easy entrance of their DNA into cells.

“In nature, viruses are precisely self-assembled by their coating proteins and genome,” Geng said. “We have to learn from nature and engineer a safer yet efficient gene delivery system for medical use.”

Synthetically packaging long strands of DNA into compact, small structures has long been a challenge, but Geng’s team has developed a unique combinative self-assembly method that allows scientists to control precisely the size and shape of the vector. The Geng team synthesized small peptides – which are short chains of amino acids – that bind to genes and emulate natural proteins to minimize potential immune reactions. The researchers then attach the small peptides onto a biocompatible polymer scaffold to create a clustered effect. The clustered peptides of the combined molecule will automatically assemble with DNA, while the polymer wraps around the assembly, creating a protective shell. The researchers have discovered that the assembly process is extremely sensitive to the clustered arrangement of the gene-binding peptides. To change the shape and size of the vectors, the researchers simply change the attachment density of the peptides on the polymer scaffold, resulting in shapes that vary from spherical to donut shaped to long filaments.

“These gene vectors also can be further conjugated with targeting molecules, which will allow us to deliver the right genes to the right spot in our body,” Geng added.

With the synthesis of the vector complete, the scientists now plan to assess how effective it is in integrating genes into cancer cells. Geng said her ultimate goal is to use tumor-suppressor genes to treat cancer. Another possibility is to use the synthetic vectors to introduce genes that boost the immune system.

“Our research is still at an early stage,” Geng said, “but we’ve developed a very promising system.”

The research was funded by the UGA Research Foundation and the Georgia Cancer Coalition.

By Sam Fahmy

Glaucoma procedure now available at Mayo Clinic Aims to Prevent Further Eye Damage

For the first time in Florida, patients with glaucoma have a new treatment option known as the Trabectome. The minimally invasive procedure, which is available at Mayo Clinic and takes about 20 minutes, is designed to decrease pressure within the eye and stabilize the vision.

"The goal of this procedure is to prevent further damage within the eye," says ophthalmologist Rajesh Shetty, M.D. He says that some patients have been able to reduce or eliminate use of daily eye drop medications that regulate intraocular pressure.

Glaucoma, the second leading cause of blindness, is a disease that causes irreversible damage to the optic nerve from increasing pressure within the eye. This occurs because the eye produces a clear fluid that does not drain adequately and raises the eye pressure. The first sign of glaucoma is a loss of peripheral vision that is usually not noticed by the patient until it affects the central vision. Unfortunately, vision lost to glaucoma can't be restored so treatment aims to reduce eye pressure to prevent further damage.

Traditionally, ophthalmologists first prescribe eye drops to reduce the eye pressure, and if that doesn't work, they can perform a laser procedure (trabeculoplasty) to the existing internal drainage canal around the base of the cornea. A more invasive treatment is trabeculectomy, a surgical technique to create a new drain for the eye.

The Trabectome procedure uses a small probe that opens the eye's drainage system through a tiny incision in the eye's cornea. "It removes a small portion of the eye's natural drainage system so that it functions better," says Dr. Shetty. He says it should be used when eye drops and laser trabeculoplasty fail to reduce pressure and before trabeculectomy is considered. "I see this as another rung in the ladder of treatment for glaucoma," he says.

So far, more than a dozen patients have had the procedure at Mayo Clinic in Florida, although the technique has been available at Mayo Clinic in Rochester for a few years. To date, several thousand procedures have been done nationwide, according to Dr. Shetty.

The procedure requires very little sedation and patients generally recover within a week. "We have been pleased with the results," he says, noting that although lost vision cannot be restored with the procedure, some patients have reported improved vision overall after surgery.

An estimated 4 million Americans are affected by glaucoma. Glaucoma screenings are suggested for anyone over 40 every two to four years. A routine exam can help identify risk for glaucoma and early signs of the disease. Risk factors for glaucoma include: a family history of the disease, African or Hispanic ancestry, diabetes, certain rare eye diseases and having had an eye injury or having used any corticosteroid preparation for a prolonged period.

Unusual Rotavirus Season May Be Due to Newly Introduced Vaccine

Rotavirus activity in the ongoing 2007-2008 season appears to have started later than usual and have been less severe than during any of the previous seasons for which data are available, according to an interim report issued in today's early release edition of the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (MMWR).

Rotavirus is the leading cause of severe gastroenteritis (vomiting and diarrhea) in infants and young children, annually causing about 410,000 physician office visits, 205,000-272,000 emergency department visits, 55,000-70,000 hospitalizations, and between 20 and 60 deaths among US children less than 5 years of age. Worldwide, rotavirus causes approximately 1,600 deaths each day among children less than 5 years of age.

Data from around the United States indicate that during the ongoing season, rotavirus activity was delayed by about three months compared with the start time for the previous 15 years. The season began at the end of February instead of November, the usual start time, and the season peaked at the end of April instead of March, the usual peak time.

Hospitalizations, emergency department visits, and physician visits were also substantially reduced at some network of medical centers conducting prospective rotavirus surveillance. The number of laboratory tests performed for rotavirus from Jan. 1 to May 3, 2008, was 37 percent lower than usual, and the percent of all tests conducted for gastroenteritis that were positive for rotavirus was 79 percent lower than usual.

The report indicates that marked changes in rotavirus activity may be due to a newly introduced rotavirus vaccine for infants. In 2006, a new rotavirus vaccine, RotaTeq (Merck & Co. Inc.), was recommended for routine immunization of U.S. infants at 2, 4 and 6 months of age. Clinical trial results indicated that this live, oral vaccine prevented 74 percent of all rotavirus cases, about 98 percent of severe cases, and about 96 percent of hospitalizations due to rotavirus.

"The changes appear to be greater than expected based on the protective effects of the vaccine alone," said Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at CDC. "It is also possible that current levels of vaccination may be helping to decrease the spread of rotavirus to unvaccinated individuals in the community. Ongoing monitoring is needed to confirm the impact of vaccination this year and to monitor the impact of the vaccine on rotavirus disease and its epidemiology over time."

The data used in the new report were obtained from the National Respiratory and Enteric Virus Surveillance System (NREVSS) and from the New Vaccine Surveillance Network (NVSN). NREVSS is a voluntary network of U.S. laboratories that provide CDC with weekly reports of the number of tests performed and positive results obtained for a variety of
pathogens, including rotavirus.

Rotavirus is highly contagious. Large amounts of the virus are shed in the stool of infected persons and can be spread by contaminated hands and objects. Children can spread rotavirus both before and after they become sick with diarrhea, and they can pass the virus to household
members and other close contacts.

FDA Approves PrandiMet™, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes

BUSINESS WIRE--Sciele Pharma, Inc. (NASDAQ:SCRX) and Novo Nordisk Inc. today announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin®) and insulin sensitizer, metformin, for the treatment of type 2 diabetes. Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet to physicians in the U.S. Sciele Pharma anticipates that PrandiMet will be available to physicians and patients in the U.S. in the second half of 2008.

PrandiMet has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.

The FDA approved PrandiMet based upon data demonstrating that PrandiMet 1 mg./500 mg. and 2 mg./500 mg. resulted in similar bioequivalence to co-administration of corresponding doses of repaglinide and metformin HCl as individual tablets.1

As the worlds leading diabetes care company, Novo Nordisk is dedicated to providing a broad portfolio of treatments that respond to each stage of diabetes. With PrandiMet, physicians will have a simplified option for Prandin® and metformin combination therapy, said Jerzy Gruhn, president, Novo Nordisk Inc.

PrandiMet is the first and only fixed-dose combination of a fast-acting secretagogue and metformin. The combination of metformin and repaglinide has been shown to safely and effectively reduce hemoglobin A1c levels. PrandiMet offers the convenience of two medications in one pill. PrandiMet is comprised of two well-established anti-diabetic medications: Prandin®, a fast-acting insulin secretagogue and metformin, an insulin sensitizer. Prandin® stimulates the release of insulin from the pancreas after a meal, thereby reducing PPG. Metformin decreases the amount sugar produced by the liver, reducing FPG, and helps the body respond better to the insulin it makes naturally.

We are very pleased with approval of PrandiMet, an important new treatment option for people struggling to keep their blood glucose in control, said Patrick Fourteau, Chief Executive Officer of Sciele Pharma, Inc. Weve seen that many patients need more than one therapy to control their type 2 diabetes and the combination of Prandin® and metformin in one pill will give patients convenient access to two medications trusted for their efficacy and safety.

Tuesday, June 24, 2008

Number of People with Diabetes Increases to 24 Million

Diabetes now affects nearly 24 million people in the United States, an
increase of more than 3 million in approximately two years, according to
new 2007 prevalence data estimates released today by the Centers for
Disease Control and Prevention (CDC). This means that nearly 8 percent
of the U.S. population has diabetes.

In addition to the 24 million with diabetes, another 57 million people
are estimated to have pre-diabetes, a condition that puts people at
increased risk for diabetes. Among people with diabetes, those who do
not know they have the disease decreased from 30 percent to 25 percent
over a two-year period.

"These new estimates have both good news and bad news, said Dr. Ann
Albright, director of the CDC Division of Diabetes Translation. "It is
concerning to know that we have more people developing diabetes, and
these data are a reminder of the importance of increasing awareness of
this condition, especially among people who are at high risk. On the
other hand, it is good to see that more people are aware that they have
diabetes. That is an indication that our efforts to increase awareness
are working, and more importantly, that more people are better prepared
to manage this disease and its complications."

Diabetes is a disease associated with high levels of blood glucose
resulting from defects in insulin production that causes sugar to build
up in the body. It is the seventh leading cause of death in the country
and can cause serious health complications including heart disease,
blindness, kidney failure, and lower-extremity amputations.

Among adults, diabetes increased in both men and women and in all age
groups, but still disproportionately affects the elderly. Almost 25
percent of the population 60 years and older had diabetes in 2007. And,
as in previous years, disparities exist among ethnic groups and minority
populations including Native Americans, blacks and Hispanics. After
adjusting for population age differences between the groups, the rate of
diagnosed diabetes was highest among Native Americans and Alaska Natives
(16.5 percent). This was followed by blacks (11.8 percent) and Hispanics
(10.4 percent), which includes rates for Puerto Ricans (12.6 percent),
Mexican Americans (11.9 percent), and Cubans (8.2 percent). By
comparison, the rate for Asian Americans was 7.5 percent with whites at
6.6 percent.

The data are an update of diabetes prevalence estimates last reported
two years ago and now published in the 2007 National Diabetes Fact Sheet
developed by CDC in collaboration with multiple agencies under the U.S.
Department of Health and Human Services and other federal agencies.

CDC also is releasing estimates of diagnosed diabetes for all counties
in the United States. Derived from the agency's Behavioral Risk Factor
Surveillance Survey (BRFSS) and census data, the estimates provide a
clearer picture of areas within states that have higher diabetes rates.
Nationally, the data indicate increased diabetes rates in areas of the
Southeast and Appalachia that have traditionally been recognized as
being at higher risk for many chronic diseases, including heart disease
and stroke.

"These data are an important step in identifying the places in a state
that have the greatest number of people affected by diabetes," said Dr.
Albright. "If states know which communities or areas have more people
with diabetes, they can use that information to target their efforts or
tailor them to meet the needs of specific communities."

CDC, through its Division of Diabetes Translation, funds diabetes
prevention and control programs in all 50 states, as well as the
District of Columbia and eight U.S. territories and island
jurisdictions. The National Diabetes Education Program, co-sponsored by
CDC and the National Institutes of Health (NIH), provides diabetes
education to improve the treatment and outcomes for people with
diabetes, promote early diagnosis, and prevent or delay the onset of
diabetes.

Outreach Initiatives Lead to Shift in Stage of Breast Cancer Diagnosis in African-American Women

Researchers at Emory University have determined that community education outreach and internal navigation programs lead to a significant shift in stage at diagnosis of breast cancer among African-American women.

Sheryl Gabram, MD, an Emory Winship Cancer Institute surgical oncologist, and her colleagues report a doubling in the proportion of cases caught at the earliest stage and a nearly reciprocal drop in the proportion of cancers at most advanced stage in African-American women who participated in community education or internal navigation programs.

The research suggests that initiatives aimed at raising awareness and utilization of breast cancer screening may improve breast cancer survival rates for African-American women, who have a higher risk of death from the disease compared to whites. The study is published on line this month and in the August 1, 2008 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

A disproportionate number of deaths from breast cancer occur in African-American women, a disparity attributed to later stage of disease at diagnosis and diagnosis at an earlier age. Treatment differences may also contribute to the higher risk of mortality.

To assess the effectiveness of outreach programs on breast cancer stage among African-American women, Dr. Gabram, who also is director of the AVON Comprehensive Breast Center at the Georgia Cancer Center for Excellence at Grady Memorial Hospital in Atlanta, reported on a program implemented in 2001 with two components: Community Health Advocacy and Patient Navigation. The Community Health Advocacy component includes public educational programs that encourage mammography screening, teach the importance of breast self exams, and instruct individuals to see a trained healthcare provider.

The Patient Navigation component involves breast cancer survivors who communicate directly with all patients who have been diagnosed with breast cancer in the AVON Breast Center. Patient Navigators (PNs) encourage patients to follow-up with recommended medical care and access needed resources such as finances, transportation, and support services.

Between 2001 and 2004, the program conducted a total of 1,148 community interventions for more than 10,000 participants. During that same time period, a total of 487 patients were identified, diagnosed, and treated for breast cancer at the AVON Comprehensive Breast Center (89 percent African American, 5 percent Caucasian, 2 percent Hispanic, and 4 percent other race/ethnicity).

Dr. Gabram and her team found that there was a doubling in the proportion of Stage 0 non-invasive breast cancers (from 12.4 percent to 25.8 percent) over the study period, while the proportion of women diagnosed with Stage IV invasive breast cancers dropped from 16.8 percent to 9.4 percent.

"This reciprocal deviation of Stage 0 versus Stage IV cancers has implications on prognosis, and ultimately outcome for these women if recommended treatment guidelines are followed," say the authors. They, along with leadership from Emory University's Rollins School of Public Health team, are currently conducting studies to see if the Patient Navigation program successfully influences patients to accept treatment recommendations and to adhere to appointments after they are diagnosed with breast cancer. Research has revealed that many patients with breast cancer refuse or do not receive appropriate therapy.

The authors concluded that programs with Community Health Advocates (CHAs) who encourage mammography screening and stress the importance of early diagnosis should be jointly emphasized with the efforts of the Patient Navigators (PNs) who encourage acceptance of and adherence to treatment standards.

Article: "Effects of an outreach and internal navigation program on breast cancer diagnosis in an urban cancer center with a large African-American population." Sheryl G.A. Gabram, Mary Jo B. Lund, Jessica Gardner, Nadjo Hatchett, Harvey L. Bumpers, Joel Okoli, Monica Rizzo, Barbara J Johnson, Gina B Kirkpatrick, and Otis W. Brawley. CANCER; Published Online: June 23, 2008 (DOI: 10.002/cncr.23568); Print Issue Date: August 1, 2008.

Monday, June 23, 2008

Traumatic Brain Injuries Can Result From Senior Falls

PRNewswire- -- Traumatic brain injuries due to falls caused nearly 8,000 deaths and 56,000 hospitalizations in 2005 among Americans 65 and older, according to a new report from the Centers for Disease Control and Prevention released in the June issue of the Journal of Safety Research.

Traumatic brain injuries, or TBIs, are caused by a bump or blow to the head; however, they maybe missed or misdiagnosed among older adults. TBI often results in long-term cognitive, emotional, and/or functional impairments. In 2005, TBIs accounted for 50 percent of unintentional fall deaths and 8 percent of nonfatal fall-related hospitalizations among older adults.

Falls are not an inevitable consequence of aging, but they do occur more often among older adults because risk factors for falls are usually associated with health and aging conditions. Some of these conditions include mobility problems due to muscle weakness or poor balance, loss of sensation in feet, chronic health conditions, vision changes or loss, medication side effects or drug interactions, and home and environmental hazards such as clutter or poor lighting.

"Most people think older adults may only break their hip when they fall, but our research shows that traumatic brain injuries can also be a serious consequence," said Dr. Ileana Arias, director of CDC├ó€²s National Center for Injury Prevention and Control. "These injuries can cause long-term problems and affect how someone thinks or functions. They can also impact a person's emotional well-being."

Each year, one in three older Americans (65 and older) falls, and 30 percent of falls cause injuries requiring medical treatment. In 2005, nearly 16,000 older adults died from falls, 1.8 million older adults were treated in emergency departments, and 433,000 of these patients were hospitalized. Falls are the leading cause of injury deaths and nonfatal injuries for those 65 and over.

This study analyzed 2005 data from the National Center for Health Statistics' National Vital Statistics System and the Agency for Healthcare Research and Quality's Nationwide Inpatient Sample. Key findings are:

  --  Death rates for fall-related TBIs were higher among men than women
(26.9 per 100,000 and 17.8 per 100,000, respectively).
-- Rates for fall-related TBI hospitalizations were similar Hidden
among men and women (146.3 per 100,000 and 158.3 per
100,000, respectively).
-- Death and hospitalization rates for fall-related TBIs generally
increased with age.

Additional findings:

-- The majority of men and women hospitalized with a fall-related TBI
spent two to six days in the hospital (54.9 percent of men; 61.5
percent of women).
-- The median total charges for these hospitalizations were $19,191 for
men and $16,006 for women.

Arias also points out that as more baby boomers reach retirement age, these types of injuries will increase demands on the health care system unless action is taken to prevent the injuries. "CDC has developed tips and suggestions for older adults, their caregivers, health care providers, and communities to help prevent falls," Arias said.

For older adults, their children, caregivers, and health care providers, CDC recently developed the 'Help Seniors Live Better, Longer: Prevent Brain Injury' initiative. Developed in collaboration with 26 organizations, it features easy-to-use English- and Spanish-language materials in a concise question-and-answer format to help prevent, recognize, and respond to TBI. For more information and materials, visit www.cdc.gov/BrainInjuryInSeniors.

CDC has also created resources for practitioners and community-based organizations. Preventing Falls: What Works A CDC Compendium of Effective Community-based Interventions from Around the World and Preventing Falls: How to Develop Community Based Fall Prevention Programs for Older Adults can be downloaded or ordered at www.cdc.gov/ncipc/preventingfalls.

Depression and Diabetes: Fellow Travelers, Researchers Say

Researchers have long known that type-2 diabetes and depression often
go hand in hand. However, it's been unclear which condition develops
first in patients who end up with both. Now, a new study led by Johns
Hopkins doctors suggests that this chicken-and-egg problem has a dual
answer: Patients with depression have an increased risk of developing
type-2 diabetes, and patients with type-2 diabetes have an increased
risk of developing depression.

For the study, published in the June 18 Journal of the American
Medical Association, diabetes expert Sherita Hill Golden, M.D.,
M.H.S., and her colleagues took advantage of data generated by the
Multi-Ethnic Study of Atherosclerosis (MESA), which examined risk
factors for atherosclerosis, or hardening of the arteries, in an
ethnically diverse group of 6,814 men and women between ages 45 to
84. Participants in the MESA study identified themselves when they
enrolled as white, black, Hispanic or Chinese.

During MESA, participants made three visits to clinics over the
course of three years to be examined for various atherosclerosis risk
factors, including type-2 diabetes and symptoms of depression, which
could serve as a precursor for full-blown clinical depression.

The study also collected information on other atherosclerosis risk
factors, such as participants' body-mass indices, blood pressure,
diet and exercise patterns, and smoking habits, as well as
information correlated with health in general, such as income and
socioeconomic factors.

Mining the data for their own purposes, Golden and her colleagues
excluded from their analysis all participants who had high fasting
glucose, an indication of diabetes, at the initial clinic visit. They
then looked to see whether participants who initially had elevated
symptoms of depression, as indicated through a questionnaire, were
more likely than those who didn't to develop high fasting glucose at
the end of the three-year study period.

Results showed that those with elevated depressive symptoms were 42
percent more likely overall to develop diabetes by the end of the
study than those without these symptoms. Moreover, the stronger the
symptoms, the higher the risk of diabetes, a "dose response" that
lends strength to the findings.

Even when the researchers accounted for such factors as overweight,
lack of exercise, and smoking, the risk of developing diabetes was
still 34 percent higher for patients with depressive symptoms.

To investigate whether diabetes could lead to depression, Golden and
her colleagues used the same pool of MESA information and excluded
those who had elevated depressive symptoms at the initial clinic
visit. Then, they looked to see whether those who had high fasting
glucose-with or without a formal diagnosis of diabetes-were more
likely to develop depressive symptoms by the end of the study.

The researchers found that patients treated for diabetes, about 9
percent of the group, were about 54 percent more likely to develop
elevated depressive symptoms than those without diabetes.

Surprisingly, those with prediabetes or untreated diabetes were about
25 percent less likely to develop elevated depressive symptoms than
people with normal fasting glucose, a finding Golden's team cannot
explain at this time.

Golden, an associate professor of medicine and epidemiology at the
Johns Hopkins University School of Medicine, speculates that
depression may lead patients to develop behaviors that trigger
diabetes or make it worse, such as overeating, not exercising or
smoking. Similarly, keeping up with the often extensive treatment
regimens to care for their diabetes may make patients' depression
worse. Understanding how one condition might lead to another could
improve treatments for both problems, she says.

"Having both diabetes and depression can make it difficult for
patients to get the good clinical outcomes that we like to see for
each of these conditions," says Golden. "To make sure that patients
with diabetes and depression receive the best care, we wanted to get
to the bottom of the connection between these two conditions.

"It's important that doctors be attuned to look for both conditions
in patients at risk for either diabetes or depression," Golden adds.
"We may want to develop interventions for both treatments, instead of
just one or the other."

Other Johns Hopkins researchers who participated in this study
include Mariana Lazo, M.D.. M.Sc.; Hochang Benjamin Lee, M.D.; and
Constantine Lyketsos, M.D., M.H.S.

The MESA study was supported by grants from the National Heart, Lung,
and Blood Institute. Golden and her colleagues' research was
supported by a Patient-Oriented Mentored Scientist Award through the
National Institute of Diabetes and Digestive and Kidney Diseases.

Sunday, June 22, 2008

Team Teaches CPR to Afghan Medical Providers

Six Afghan medical providers learned basic lifesaving skills at a Panjshir Provincial Reconstruction Team cardiopulmonary resuscitation course held at the Rokha Clinic on June 18.

Air Force Staff Sgt. Janine Duschka, a PRT medical technician deployed from Andrews Air Force Base, Md., taught the course.

"It is important to teach the local medical providers, because it gives them another tool to save lives," Duschka said. "The tools they take home with them today are not ones they have to carry in their medical bags, and they're not something that they have to spend their money on. They're taking home knowledge that they can share with the rest of their staffs."

The medical providers were from six different clinics and four of the province's seven districts.

"This training is crucial, because most of the province's health care providers are in rural locations, so they need to be able to do [CPR] in order to get their critical patients to the hospital or to a better clinic," said Dr. Shirdell, Panjshir health and medical services officer.

The CPR class is the one-day American Heart Association course for health care providers authorized by the Military Training Network in Bethesda, Md. It covers not only CPR for patients of all ages, but also how to handle someone who is choking and the proper use of an automated external defibrillator unit.

The course also focuses on how to assess a patient to see if CPR is even necessary, and Duschka said she sees patient assessment as one of the main tools taught by the course.

"Now the medical providers know how to assess the signs the patient is giving instead of just reacting to a patient when they arrive," Duschka said. "Many of the Afghan medical providers I've dealt with in the past would have immediately started to give artificial breathing or CPR just because a patient's eyes were closed or they were unconscious, even if the patients were breathing normally already."

While some of the medical providers had learned prior forms of resuscitation, this course was new to most of them.

"They didn't have a preconceived notion of what CPR should be, since they've never taken any of the older CPR courses, so it was actually easier for me to teach them than it is teaching American students," Duschka said. "These providers all know how important this training is, and they all came ready to learn."

This is the first class out of a 15-class schedule, and I think it went very well and we all learned something from the class, Duschka said.

While Duschka taught her students the requirements from the course, they taught her some creative ways they've come up with to handle some of the trickier everyday medical situations.

For example, if a pregnant woman were choking, the providers said, they'd use a head-scarf to wrap around the woman if they couldn't reach their arms around her. Their solution uses an item that every Afghan woman keeps with her.

"Even though we're taught to use everything and anything that you have available to save the patient, using the scarf is an ingenious option that I never would have considered," Duschka said. "Although using the scarf is not a treatment of choice, the solution shows the providers clearly think outside of the box to help their patients in any way they can."

After spending the day teaching and learning from the local providers, Duschka was comfortable they would be able to provide better care to anyone who came into their clinics.

"If I came into their clinics, I know they could assess me, understand what was happening and treat me properly," she said. "Hopefully they won't ever have to use this course, but I'm happy to have been able to give the extra knowledge."

Shirdell agreed with Duschka.

"Whether they need to use [CPR] or not, they are learning that they always need to be in touch with the patient, and it is important to know what to do with a patient in any emergency situation," Shirdell said.

The PRT's CPR training program will continue throughout the year, and Duschka said she hopes to get out to different clinics in each of the province's seven districts.

Author Air Force Capt. Jillian Torango serves with the Panjshir Provincial Reconstruction Team Public Affairs Office

Effective Treatment for Sickle Cell Underused by Doctors

Uncertainties about proper use and possible long-term effects of hydroxyurea in the treatment of sickle cell anemia may be wrongly influencing doctors to avoid prescribing it to those in serious need, according to results of a literature review by specialists at Johns Hopkins.

“We know that many people with sickle cell disease aren’t being offered this drug, which is the only one we have to treat this disease,” says Sophie Lanzkron, M.D., assistant professor of medicine and oncology at the Johns Hopkins University School of Medicine and director of the Sickle Cell Center for Adults at Johns Hopkins.

In a bid to heighten awareness about the nature of the uncertainties and correct clinical use of the drug, the U.S. Department of Health and Human Services selected Lanzkron and her colleagues at Johns Hopkins to gather information from previously published studies on hydroxyurea.

First, they combed through databases to select randomized clinical trials, observational studies and case reports that evaluated the drug’s effectiveness and incidences of toxic side effects. They excluded the poorer quality data and non-English publications and carefully analyzed data from 246 articles.

What emerged, the researchers say, is a clear picture of the drug’s effectiveness.

Specifically, they found that the number of intensely painful sickle cell “crises,” caused when misshapen, “sickled” red blood cells clump in blood vessels, dropped by 68 to 84 percent in people taking hydroxyurea. Their hospital admissions declined by 18 to 32 percent.

On the biological side, amounts of fetal hemoglobin, a blood component that seems to decrease sickle cell symptoms, increased by 4 to 20 percent after patients began taking hydroxyurea.

On the negative side of the risk/benefit ledger, studies in mice also indicated that hydroxyurea impairs sperm development. The researchers concluded that this effect could be present in human patients as well. The review could not conclude with any confidence that hydroxyurea increased or decreased the risk of leukemia or other tumors, leg ulcers and pregnancy complications.

In the team’s report, published in the June 17 Annals of Internal Medicine, they conclude that hydroxyurea be considered a viable treatment option, but emphasized the need for more quality research.

“It’s clear from our literature review that hydroxyurea works, but we need to do much more work to understand how it works and the best ways to use it,” Lanzkron says.

Sickle cell anemia, an inherited disorder that affects mostly people of African and Hispanic heritage, is named for the crescent- or sickle-shaped blood cells caused by the disease. The C-shaped cells periodically clump inside blood vessels, blocking circulation and causing severe anemia, increased risk of infections or strokes, and episodes of extreme pain that can last hours or days. About 70,000 people have sickle cell disease in the United States.

This research was funded by the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services.

Other Hopkins researchers who participated in this research include John J. Strouse, M.D.; Renee Wilson, M.Sc.; Mary Catherine Beach, M.D., M.P.H.; Carlton Haywood, M.A.; HaeSong Park, M.D., M.P.H.; Katherine Witkop, M.D., M.P.H.; Eric. B. Bass, M.D., M.P.H.; and Jodi B. Segal, M.D., M.P.H.

Friday, June 20, 2008

How Montezuma Gets His Revenge

How Montezuma Gets His Revenge
--Johns Hopkins Researchers Discover Clue to How Dysentery Parasite Might Evade Immune System

Every year, about 500 million people worldwide are infected with the parasite that causes dysentery, a global medical burden that among infectious diseases is second only to malaria. In a new study appearing in the June 15 issue of Genes and Development, Johns Hopkins researchers may have found a way to ease this burden by discovering a new enzyme that may help the dysentery-causing amoeba evade the immune system.

"This is the first enzyme to be identified that looks like it could mediate immune system evasion," says Sin Urban, Ph.D., an assistant professor of molecular biology and genetics at Hopkins.

The EhROM1 enzyme, it turns out, is part of an ancient group of enzymes-they are found in every branch of life from bacteria to man-known as rhomboid enzymes. In most animals, rhomboid enzymes seem to play a role in cell-to-cell communication, but a couple of years
ago Urban found that malaria parasites use rhomboid enzymes for a more sinister purpose: to enter host cells uninvited.

That led his team to scour the DNA of other parasites to see if any of them also had genes that encode rhomboid enzymes. They found that the dysentery-causing amoeba Entamoeba histolytica contains one rhomboid enzyme and named it EhROM1.

"Plasmodia, the parasites that cause malaria, grab onto a host cell and push their way in," explains Urban. "Once inside they use rhomboid enzymes to cut themselves loose." But amoebas don't enter cells to cause dysentery, so Urban's team set out to figure out how
these parasites use EhROM1.

They first identified protein targets cut by EhROM1 by looking for amoeba proteins that had structural signatures similar to those cut by malaria rhomboids. They found these signatures in a family of proteins-lectins-that are found on cell surfaces. The researchers put both proteins into cells and verified that EhROM1 does cut one particular lectin, and the more EhROM1 they added, the more lectin pieces resulted.

Every cell has on its surface proteins recognizable by sentries of the immune system that constantly survey the body for intruders, and amoebas are no different. To evade the immune system, amoebas shift all their surface proteins to the rear end of the cell then, like a dump truck, shed these proteins into the fluid around them.

Lectin, it turns out, is one of the proteins that during immune evasion moves to the rear and is shed by the amoeba. So collaborating researchers at Stanford University then looked to see if EhROM1 follows lectin and sure enough found that EhROM1 clusters at the cap-the cluster of surface proteins waiting to be shed.

"We're excited to see if EhROM1 plays a specific role in the cap shedding during immune evasion," says Urban.

What's more, the EhROM1 enzyme is remarkably similar to those found in malaria parasites, suggesting that any potential drugs targeting EhROM1 might be able to treat two of the world's most prevalent diseases.

The research was funded by the National Institutes of Health and the Burroughs-Wellcome Fund.

Authors on the paper are Leigh Baxt and Upinder Singh of Stanford University, and Rosanna Baker and Urban of Hopkins.

Thursday, June 19, 2008

HIV Screening Found Cost-Effective in Older Adults

Recent studies suggest that large numbers of Americans remain sexually active well into their 60's, 70's and even 80's. But researchers at Duke University Medical Center say seniors may be overlooked as possible carriers of the AIDS virus, and based on a new study, they are recommending screening for most adults ages 55 to 75 as a sensible, cost-effective way to prolong life and decrease the spread of the disease.

"Many of us might think of HIV as associated with teens and younger adults, but statistics show that 19 percent of those infected were diagnosed at age 50 or older," says Gillian Sanders, Ph.D., associate professor of medicine at the Duke Clinical Research Institute and the lead author of the study appearing in the June 17 issue of the Annals of Internal Medicine.

The Centers for Disease Control recommends HIV screening for patients aged 13 to 64, and Sanders says it is clearly cost effective to screen younger populations – even if the prevalence of the disease is low – because any benefits will be enjoyed over a much longer period. But HIV is less prevalent among older Americans. In addition, older patients are also more likely to have fewer sex partners and more life-threatening conditions that might make routine screening less economically attractive.

"Until now, we've assumed that screening made a lot of sense in younger people but we really didn't know if it was a good use of our healthcare resources in older folks," says Sanders. "That's why we needed to do this study."

Sanders worked with colleagues at Stanford University, the Veterans Affairs Palo Alto Health Care System and St. Michael's Hospital in Toronto in evaluating the cost-effectiveness of HIV screening among patients aged 55 to 74.

The authors used a computerized model that tracked older patients over their lifetime. The model noted whether the patients were screened or not, their HIV status, the clinical course of any HIV disease, the cost and consequences of any transmission and the cost and effects of treatment. They also took into account the likelihood of any age and gender-related issues that could shorten the patients' lives.

Cost-effectiveness is often measured in quality-adjusted life-years (QAYLs), a figure that takes into account numerous factors, including the quality of life and the length of life.

The authors noted that the cost-effectiveness of HIV screening was dependent on the prevalence of the disease, the age of the patient, the cost of counseling and whether the patient was sexually active.

Assuming that 0.5 percent of the study population were HIV-positive, the researchers found that HIV screening for patients aged 65 who were not sexually active would cost $55,440 per QALY gained, while screening for sexually-active 65 year olds would cost $30,020 per QALY. Sanders says such figures are within the range of other accepted cost-effective ratios, and in the United States, these would generally be considered "a good use of our healthcare dollars."

Based on case studies, they also found that screening and early diagnosis for a 65-year old HIV-infected patient could mean an extra half year of life, while for a 75-year old HIV-infected patient, it would mean an extra four months of life.

"This suggests that HIV screening for many older adults is indeed cost-effective, particularly for those who are sexually active," says Sanders, who says some of the newer, lower-cost, streamlined counseling formats might be particularly appropriate for this population.

"All of us also need to remember that age doesn't protect anyone from HIV. You're as vulnerable at 60 as you are at 16."

The study was funded by the Department of Veterans Affairs, the National Institute on Drug Abuse, the National Institute on Aging and the Ontario HIV Treatment Network.

The senior author of the study is Douglas Owens, a senior investigator at the VA Palo Alto Healthcare System and a professor of medicine at Stanford. Other co-authors are Mark Holodniy, also at the VA and a professor of medicine at Stanford, and Ahmed Bayoumi, a professor of medicine and health policy, management and evaluation, at the University of Toronto.

Wednesday, June 18, 2008

Computer Predicts Anti-Cancer Molecules

A new computer-based method of analyzing cellular activity has correctly predicted the anti-tumour activity of several molecules. Research published today in BioMed Central’s open access journal, Molecular Cancer, describes ‘CoMet’ – a tool that studies the integrated machinery of the cell and predicts those components that will have an effect on cancer.

Jeffery Skolnick, professor in the School of Biology and director of the Center for the Study of Systems Biology, in collaboration with John McDonald, chair of the School of Biology, led a team from the Georgia Institute of Technology who have developed this new strategy.

“This opens up the possibility of novel therapeutics for cancer and develops our understanding of why such metabolites work. CoMet provides a deeper understanding of the molecular mechanisms of cancer,” said Skolnick.

The small molecules that are naturally produced in cells are called metabolites. Enzymes, the biological catalysts that produce and consume these metabolites, are created according to a cell’s genetic blueprints. Importantly, however, the metabolites can also affect the expression of genes.

“By comparing the gene expression levels of cancer cells relative to normal cells and converting that information into the enzymes that produce metabolites,” said Skolnick, “CoMet predicts metabolites that have lower concentrations in cancer relative to normal cells.”

The research proves that when such putatively depleted metabolites are added to cancer cells, they exhibit anticancer properties. In this case, growth of leukemia cells was slowed by all nine of the metabolites suggested by CoMet.

The future for this treatment looks bright, added McDonald. “While we have only performed cell proliferation assays, it is reasonable to speculate that some metabolites may also exhibit many other anticancer properties,” he said. “These could be important steps on the road to a cure.”

United States and China Outline Progress on Agreement on Food and Feed Safety

U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

The parties are meeting this week in Annapolis, Md., as part of the fourth session under the United States-China Strategic Economic Dialogue (SED).

“Today's progress report reflects strong and sustained cooperation by both nations to strengthen the safety of food products exported to the United States from China,” Secretary Leavitt said. “I'm very pleased with our efforts and commend our Chinese counterparts for their commitment to this important work.”

The MOA, signed during the third session under the SED in December of 2007, established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries. Since its signing, HHS’ Food and Drug Administration (FDA) and AQSIQ have planned a joint implementation work strategy and have begun the initial steps called for under the agreement.

The statement describes progress in several important areas:

  • Establishment of a mechanism for cooperation on significant events related to food and feed safety, including designated points of contact, emergency contacts, and thresholds for notifications; enhancing the exchange of information on the safety of food and feed safety; and developing a better understanding by both sides of each others’ respective regulatory systems.
  • Development of concrete steps that will lead to a system whereby AQSIQ will electronically certify to FDA that specific products sent for export to the United States meet FDA standards for safety and manufacturing quality.
  • Focus efforts on inspections and supervision and laboratory testing standards to ensure food and feed safety. The United States agreed to conduct training for Chinese officials on U.S. regulatory standards and requirements.
  • Establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.

HHS/FDA and Chinese officials continue to work on implementing a second Memorandum of Agreement signed in December to enhance the safety of a variety of medical products.

For more information on the December 2007 MOA on the Safety of Food and Feed, go to http://globalhealth.gov/news/agreements/ia121107b.html.

To view the Joint Progress Statement Regarding the Five-Year Work Plan under the MOA, visit http://www.fda.gov/bbs/topics/news/international/progress_HHS_China.pdf.

America Supports You: Group Offers Free Mental Health Counseling

Mental Health practitioners nationwide are donating their time and services to provide free, confidential counseling to military people and their families.

"Combat affects everyone in one way or another," explained Dr. Barbara Romberg in an "ASY Live" interview on BlogTalkRadio. "Most people react when exposed to a situation where there are extreme or horrific events; it is a human reaction to abnormal situations."

ASY Live is part of the Defense Department's America Supports You program, which connects citizens and companies with servicemembers and their families serving at home and abroad.

Romberg, founder and president of "Give an Hour," said she started her nonprofit organization to educate servicemembers and their families about the seriousness of post-traumatic stress disorder and the importance of taking steps to combat it.

"When we set up the organization a few years ago, the concept was very simple, she said. "We asked mental health professionals across the country to give an hour of their time."

When one of the program's providers was asked why she joined, Romberg said, her answer was equally simple. "How could I not? It's so little that they are asking of me to give," the practitioner said.

Romberg said a broad spectrum of mental health practitioners participated in Give an Hour. "We have mental health professionals of all kinds -- psychologists, psychiatrists, social workers, licensed marriage and family counselors, substance abuse counselors and pastors," she explained. "One size doesn't fit all; people need different things."

Raising awareness about PTSD is as important to the group as providing help to people who need it, she said.

"We are really launching a public education campaign to make sure our entire country understands post-traumatic stress -- what it is and why it's so important to address," she said. "Post-traumatic stress is a condition that will affect most people."

Romberg said there are important signs that a family member can identify that may be an indication that professional help may be a necessary part of the recovery process.

"Anyone might be withdrawn or irritable for awhile, but if those symptoms persist past six or eight weeks, then you need to take action," she said. "If the family member seems to be uninterested in activities that they used to be interested in before, uninterested in relationships with spouses or children, or engaging in persistent drinking or substance abuse as a way of escaping, that's a warning sign," she explained.

Nightmares, anxiety attacks and rage can lead to very serious symptoms if left untreated, she added, "but it doesn't have to become a chronic mental illness at all."

For that reason, Romberg explained, it is important that family members work to recognize symptoms and seek counseling as quickly as possible. Most people want to feel as if they can handle these issues, she said. And in fact, they can, but sometimes they need assistance, she added. That's where Give an Hour comes in.

Give an Hour provides counseling not only for servicemembers, but also for affected family members, whom Romberg defines as "anyone who loves someone who is serving."

"When someone we love is deeply affected, the consequences are usually fairly far-reaching," she explained. "Spouses and children are, of course, an immediate concern, ... but grandparents, aunts and uncles are just as affected by this situation.

"If you, as a family member, feel like you have resources," she continued, "you can put together a plan and you have ... someone else to help you think through it, and eventually encourage [your] loved one to come with [you]."

It is also important, she noted, to keep a close eye on children.

"Spouses that are focused on their husband or wife, it might be really difficult to also be concerned with their children," she said. "We see things such as regression -- a young child that's maybe 3 was potty-trained and all of a sudden starts wetting the bed or isn't eating or sleeping well."

The services offered by Give an Hour are free and ongoing, and providers stay in the network a minimum of a year, Romberg said.

"If their provider has to leave, we provide a replacement," she noted. "They are never told, 'You've used up your services here.' By building such a hard network, it's not a hardship to give an hour. And [the practitioners] are happy and eager to give."

To receive support or to register to become part of this support network, people can visit the organization's Web site, www.giveanhour.org. People seeking help can search for the nearest participating provider by entering their ZIP code.

"It can be an educational conversation or it can be setting up an appointment to meet face to face," Romberg said. "If they don't know what type of assistance they need, they can also click on the 'Contact Us' button, ... and we will help locate a provider.

"It's all about partnering, networking, reaching out, connecting -- helping them to get what they need," she said.

By Jamie Findlater
Special to American Forces Press Service

Jamie Findlater, host of "ASY Live" on BlogTalkRadio, works in the New Media directorate of the Defense Media Activity.

FDA Approves Diaphragm-Pacing Device

The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

Spinal cord injuries can cause paralysis, which can impact the muscles of the chest and abdomen, including the diaphragm—the lower abdominal muscle essential for breathing. Normally, a person inhales when the diaphragm contracts and the lungs expand with air—a person exhales when the diaphragm relaxes and the air flows back out of the lungs.

"While the NeuRx RA/4 does not cure paralysis of the diaphragm, allowing patients to be free from a mechanical ventilator for at least four hours a day may enhance their quality of life," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.

Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine.

The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale.

The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose conditions that affect fewer than 4,000 people per year.

In a multi-center trial, the device has been demonstrated to be safe and to have probable benefit to the patient by allowing at least four hours per day of freedom from a mechanical ventilator.

NeuRx DPS RA/4 is manufactured by Synapse Biomedical of Cleveland, Ohio.

Tuesday, June 17, 2008

Complications After Cardiac Surgery Increase Hospital Costs, Length of Stay by More than Two-Thirds

PRNewswire/ -- Major complications following coronary artery bypass graft (CABG) surgery, even among patients least at risk of experiencing complications, remain common and add significantly to healthcare costs, while diminishing the benefits of surgery, according to research funded and conducted by Cardiac Data Solutions. The research was published in the June 2008 Annals of Thoracic Surgery.

According to the study, the average cost of a patient undergoing isolated CABG without a perioperative complication in fiscal year 2005 was $29,477. The average incremental cost for a patient suffering one of the seven complications studied was $19,968, and the average length of stay increased from 9 days to 15.9 days.

Although mortality rates associated with CABG continue to decline, 13.64 percent of beneficiaries undergoing isolated CABG in FY 2005, or 15,579 patients, experienced one or more of seven complications studied, resulting in a total incremental annual cost to Medicare of more than $311 million.

Based on current trends, the Medicare Trust Fund is expected to be exhausted by 2019, prompting the Centers for Medicare and Medicaid Services (CMS) to no longer pay for certain avoidable complications, beginning in October of this year.

"Complications after cardiac surgery are costly ... in terms of decreasing the benefit of surgery [and]... greatly increasing the financial burden of providing cardiac surgical care," says Hari Mallidi, MD, Department of Cardiothoracic Surgery, Stanford University, who provided commentary on the research. Dr. Mallidi added that "as CMS attempts to further reduce costs in the future, there may be implications for payment with respect to the noninfectious complications that occur after cardiac surgery. If a concerted effort is made by the hospital to ensure that compliance with evidence-based approaches to decreasing perioperative infections are implemented for every cardiac surgical patient, then a decrease in infection rate might be realized."

Of the seven complications studied, the most common was also among the most expensive to treat: post-operative adult respiratory distress syndrome (ARDS), which added an average of $22,222 in hospital costs per patient or more than $111 million in incremental Medicare costs in FY 2005. The most expensive complication studied was septicemia with an incremental cost of $59,204. Both septicemia and ARDS are similar in nature to complications CMS has proposed adding to the list of non-reimbursable events beginning in October 2008. The two other most common complications studied were hemorrhage or postoperative shock and reoperation. Additional complications studied were: new onset dialysis, post-operative stroke and post-operative infection.

"The research underscores the importance of hospitals implementing quality improvement initiatives to reduce the average cost of care and improve patient outcomes," says Cardiac Data Solutions founder, April Simon, RN. "Quality improvement initiatives will become increasingly important as CMS expands the number of avoidable complications for which it will not provide incremental reimbursement."

The lead researcher was Phillip P. Brown, cardiovascular surgeon (retired) and past chairman, Department of Surgery, Centennial Medical Center. In addition to Ms. Simon, fellow researchers included: David J. Cohen, MD, interventional cardiologist and director, Cardiovascular Research, Mid America Heart Institute, St. Luke's Hospital; Aaron Kugelmass, MD, director of Cardiac Catheterization at Henry Ford Hospital; Matthew R. Reynolds, MD, electrophysiologist and director, Economics and Quality of Life Core Lab, Harvard Clinical Research Institute; and Steven D. Culler, Ph.D., associate professor, Rollins School of Public Health, Emory University.

People With Lower Incomes, Lower Education Levels Have Higher Death Rates After Experiencing Heart Attack

mdash; Researchers have long suspected that socioeconomic factors like education level and income also might affect survival rates following heart attack. In the June issue of Mayo Clinic Proceedings, Mayo Clinic researchers present new data suggesting that people with lower incomes and education levels are more likely to die after heart attack than more affluent, educated people. Over the past several decades, medical research has helped identify a list of factors that increase a person's risk for myocardial infarction, the disruption of blood flow to the heart commonly known as heart attack. These factors include behaviors such as smoking or inactivity, and a variety of physical characteristics, including high blood pressure, high blood cholesterol and obesity. Today, better awareness of heart attack signs and symptoms and improved treatments help many survive that first heart attack.

Mayo authors examined medical records from 705 patients residing in Olmsted County, Minn. — the location of Mayo Clinic — who were treated for heart attack between Nov. 1, 2002 and May 31, 2006. Researchers recorded the years of schooling completed (self-reported by the patients via a questionnaire) and neighborhood income (obtained by linking the participant address to the 2000 U.S. Census Bureau data) for each participant. Participants were divided into three income groups and three education groups. Researchers analyzed survival data across these different groups.

Among the 155 deaths recorded during the study period, one-year survival estimates across income groups were lowest for people with the lowest income. Seventy-five percent were survivors among people earning $28,732 to $44,665; 83 percent survived among people earning $49,435 to $53,561; and 86 percent survived among people earning $56,992 to $74,034. Similarly, the survival rates were lowest for participants with less education. Sixty-seven percent were survivors among those who had fewer than 12 years of education; 81 percent survived among people with 12 years of education; and 85 percent survived among people with greater than 12 years of education.

The authors say that while many previous studies have sought to link socioeconomic status and poor outcomes following heart attack, this study design has yielded some unique results.

"Interestingly, despite the higher-than-average socioeconomic status of this population, the associations of individual education and neighborhood income with death after heart attack were stronger than those reported in many previous studies," notes Mayo Clinic cardiovascular researcher Yariv Gerber, Ph.D., the study's lead author. "We think our approach of evaluating two different and complementary indicators of socioeconomic status allowed us to capture a wider spectrum of this complex theory."

Mayo researchers believe that the association observed for education could be related to education's positive effect on factors that include job opportunities, income, housing, access to nutritious foods and health insurance.

"Higher levels of education also could directly affect health through greater knowledge acquired during schooling and greater empowerment and self-efficacy," writes Dr. Gerber. "As recently reported, education is strongly associated with health literacy, which in turn affects one's ability to obtain, process, and understand basic health information and services needed to make appropriate health decisions."

Mayo researchers also point out that more specific mechanisms linking low socioeconomic status to survival following heart attack could also be related to the greater difficulty that poorer individuals with lower education levels have in attending cardiac rehabilitation programs and adhering to medications and lifestyle recommendations.

FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Those companies and individuals warned, the complete list of fake cancer 'cure' products and their manufacturers along with a consumer article on health scams can be found here, http://www.fda.gov/cder/news/fakecancercures.htm.

"Although promotions of bogus cancer 'cures' have always been a problem, the Internet has provided a mechanism for them to flourish," said Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs. "These warning letters are an important step to ensure that consumers do not become the victim of false 'cures' that may cause greater harm to their health."

The FDA urges consumers to consult their health care provider about discontinuing use of these products and to seek appropriate medical attention if they have experienced any adverse effects.

The products contain ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.

Because these products claim to cure, treat, mitigate or prevent disease, and these products have not been shown to be safe and effective for their labeled conditions of use, they are unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act.

Examples of fraudulent claims for these products include:

  • "Treats all forms of cancer"
  • "Causes cancer cells to commit suicide!"
  • "80% more effective than the world's number one cancer drug"
  • "Skin cancers disappear"
  • "Target cancer cells while leaving healthy cells alone"
  • "Shrinks malignant tumors"
  • "Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments"

The Warning Letters are part of the FDA's ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers. The initiative originated from consumer complaints and a web search for fraudulent cancer products conducted by the FDA, FTC and members of the Mexico–United States–Canada Health Fraud Working Group. Earlier this year, FTC sent Warning Letters to 112 Web sites falsely promoting cancer "treatments" and referred several others to foreign authorities.

Parties that fail to properly resolve violations cited in Warning Letters are subject to enforcement action up to and including seizure of illegal products, injunction, and possible criminal prosecution.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm .

New Imaging Device Can Detect Glaucoma Risk

A high-resolution imaging instrument developed by scientists at Duke University Medical Center can detect subtle changes in the eye and help identify patients at risk for glaucoma, decades before the disease does irreversible damage.

Doctors say this high-speed advance in optical coherence tomography may one day help prevent narrow-angle glaucoma, one of the major types of a disease considered to be the second leading cause of blindness in the world.

"We've been talking about treating glaucoma for a long time," said Sanjay Asrani, MD, an associate professor of ophthalmology with the Duke Eye Center. "Now we're changing the paradigm. We want to prevent it."

Dr. Asrani is the lead author of research on this technology which appears in the June issue of Archives of Ophthalmology.

Narrow-angle glaucoma is the most serious form of glaucoma, affecting nearly 500,000 people in the U.S. It can come on without warning, causing acute painful loss of sight. In a small percentage of patients, the damage it causes may occur gradually, but it is difficult to treat and often requires surgery. Narrow-angle glaucoma is more prevalent among people with a family history, people who are far-sighted, diabetics, and Asians.

Doctors measure the angle where the iris and cornea meet with a test called gonioscopy. The narrower the angle, the harder it is for the aqueous, or eye fluid, to drain by following its normal pathway through the Schlemm's canal which is located at the edge of the cornea. When fluid builds up, pressure within the eye increases, causing progressive damage to the optic nerve.

Using a special contact lens that is pressed to the eye, doctors performing gonioscopy can see if the drain (angle) is narrow and expected to close in the near future. They can also determine if it is scarred or abnormally shaped. However, because the gonioscope lens presses against the eye, it can make the drain appear open. The same potential for error can result from the bright light of the microscope used to view the eye. "It can make the pupil constrict and distort the angle of the drain," says Dr. Asrani.

In contrast, fourier domain optical coherence tomography (FDOCT), lets doctors make a 2D, cross-sectional image of the eye using high-resolution, high-speed beams of light without any direct contact with the eyeball. "Because it is done with infrared light spectrum rather than artificial light, we can check the drain with the room lights on and off to know what patients experience in real dark and light settings," he says. "It's also a great tool to show the patients what we are seeing. They can see how narrow their drain is, and understand the necessity of preventive procedures such as laser surgery which can open the drain."

The FDOCT test is not without drawbacks. It cannot look at the drain from 360 degrees as the gonioscopy can, nor can it detect new blood vessel growth on the drain. "However, the knowledge gained by the more sophisticated images may help in our understanding of what we, as eye doctors, could be missing," Asrani says.

"We hope this information will make the gonioscopy test more accurate, and better train ophthalmologists to perform the test. They should know the ramifications of pressing the contact lens on the patient's eye, and remember that what they are seeing under artificial light illumination may not tell the whole story."

Just as important are the implications this new imaging device holds for the future, he says. "This test has improved our understanding of glaucoma, especially narrow angle, and opens up the possibility of visualizing changes to the structures, using different pharmacologic agents and developing new surgery. It may also assist in obtaining more accurate diagnosis and provide new areas of treatment."

The co-authors of this study are Marinko Sarunic, PhD, Cecilia Santiago, MD and Joseph Izatt, PhD.

Monday, June 16, 2008

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added. The Boxed Warning will now be added to an older class of drugs known as "conventional" antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."

Antipsychotic drugs commonly are categorized into two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or "tics."

Neither class of antipsychotic is FDA-approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.

Recently, two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

An explanation of the data and advice for treating patients is available in an FDA notice to health care professionals being issued today.

The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, under the new authority of FDAAA, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient's health care professionals about any concerns.

The medications involved in this action are:

Conventional Antipsychotic Drugs

Atypical Antipsychotics

Compazine (prochlorperazine)

Abilify (aripiprazole)

Haldol (haloperidol)

Clozaril (clozapine)

Loxitane (loxapine)

FazaClo (clozapine)

Mellaril (thioridazine)

Geodon (ziprasidone)

Moban (molindrone)

Invega (paliperidone)

Navane (thithixene)

Risperdal (risperidone)

Orap (pimozide)

Seroquel (quetiapine)

Prolixin (fluphenazine)

Zyprexa (olanzapine)

Stelazine (trifluoperazine)

Symbyax (olanzapine and fluoxetine)

Thorazine (chlorpromazine)


Trilafon (perphenazine)


Sunday, June 15, 2008

HHS Awards Contracts for the Development of Faster Influenza Diagnostic Tests

HHS Secretary Mike Leavitt today announced that the Centers for Disease Control and Prevention (CDC) has awarded $12.9 million for the development of low-cost influenza tests that can detect and differentiate seasonal human influenza viruses from avian influenza within three hours.

“The early detection of emerging pandemic influenza is critical to the nation’s pandemic response,” Secretary Leavitt said. “Early detection will aid in improving patient survival, overall health outcomes, and use of containment measures in the event of an influenza pandemic.”

Currently, the process for testing for avian influenza A (H5N1) can take up to 24 hours. These awards will support advanced development of laboratory influenza tests. These tests could be performed in a hospital or a commercial laboratory and would expedite the diagnosis of large numbers of patients. The expanded testing capability enhances the hospital laboratory-based pandemic and seasonal flu diagnostic capacity in the United States.

The recipients of the contract awards are: Nanogen, Inc, San Diego, Calif. and Meso Scale Diagnostics, LLC, Gaithersburg, Md., each for $6.5 million for initial phased development. The contracts provide for funding up to $10.4 million (Nanogen, Inc.) and $12.1 million (Meso Scale Diagnostics, LLC) for additional development up to three years.

The two contracts were awarded by the Centers for Disease Control and Prevention, in partnership with the Office of Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response. The recipients were selected from among nine responses to the request for proposal.