Health: Hearsay and Headlines

Nation’s top drug official to be featured at national conference on prescription drug abuse

2012-01-10T17:55:00.002-05:00

The nation’s top official in the war on drugs will be a keynote presenter at the first National Rx Drug Abuse Summit next April.

R. Gil Kerlikowske, director of the White House Office of National Drug Control Policy (ONDCP), has identified prescription drug abuse as a top priority for public health in the United States.

“Mr. Kerlikowske is very aware of the devastating impacts of prescription drug abuse and diversion,” said Karen Kelly, president/CEO of Operation UNITE (Unlawful Narcotics Investigations, Treatment and Education), a Kentucky-based organization coordinating the event. “The Prevention Plan unveiled last year by the ONDCP recognizes the need to take a balanced approach between education, monitoring, proper disposal and enforcement efforts.”

The Summit, which will be held in Florida April 10-12, 2012, is intended to foster better understanding and cooperation between all groups – state and national leaders, law enforcement officials, medical professionals, community advocates, treatment experts, educators, private industry leaders, and others – who are finding success in battling this nationwide epidemic.

“Diversion of prescription medications from their legitimate medical uses impacts every American, not only through the devastating personal toll exacted on individuals and their families, but on an economic level as well,” Kelly stated. “This Summit encourages proactive dialogue with national experts to identify data-driven policies and solutions.”

Prior to his confirmation, Kerlikowske served as deputy director for the U.S. Department of Justice, Office of Community Oriented Policing Services, and was police commissioner of Buffalo, New York. Most of his law enforcement career was served in the St. Petersburg Police Department in Florida.

He was twice elected to be president of the Major Cities Chiefs, which is comprised of the largest city and county law enforcement agencies in the United States and Canada, and was also elected president of the Police Executive Research Forum.

In 2011, Kerlikowske received the American Medical Association’s Dr. Nathan Davis Award for Outstanding Government Service.

Joining Kerlikowske as a keynote presenter during the Summit will be:

• Dr. Nora D. Volkow, director of the National Institute on Drug Abuse (NIDA) at the National Institutes of Health, one of the nation’s foremost experts on the neurological effects of drug addiction.

• Hon. Joseph T. Rannazzisi, deputy assistant administrator for the Office of Diversion Control in the U.S. Drug Enforcement Administration (DEA), an expert in preventing, detecting and investigating the diversion of controlled pharmaceuticals.

For more information about the Summit call 1-866-678-6483, visit www.NationalRxDrugAbuseSummit.org, or follow news about the event on Twitter using @RxSummit.

Military's Groundbreaking Vaccine Targets Breast Cancer

2012-01-08T20:26:00.000-05:00

Army Col. (Dr.) George E. Peoples explains
how cancer vaccines help to combat breast
cancer during an interview at San Antonio
Military Medical Center. Peoples, director and
principal investigator for the Cancer Vaccine
Development Program, has helped to
develop a vaccine that's offering breast
cancer survivors hope for a cancer-free future.
DOD photo by Linda Hosek

Military researchers here have developed a cutting-edge cancer vaccine that's slashing breast cancer recurrence rates and giving some survivors a better shot at a cancer-free future.

After more than a decade of research and testing, the cancer vaccine, dubbed E-75, soon will move on to its final phase of testing to earn Food and Drug Administration approval, said Army Col. (Dr.) George E. Peoples, director and principal investigator for the Cancer Vaccine Development Program at San Antonio Military Medical Center here.

The team has high hopes for this vaccine and its lifesaving potential for breast cancer survivors, particularly since breast cancer is the most prevalent type of cancer seen among military beneficiaries in the hospital here, said Peoples, who also serves here as the deputy director of the U.S. Military Cancer Institute and the medical center's chief of surgical oncology.

"We've made a commitment to take care of active-duty personnel, spouses and retirees," the colonel said. "And cancer is a notable problem among beneficiaries."

The vaccine, Peoples explained, targets a protein commonly over-expressed in breast cancer cells called human epidermal growth factor receptor 2, or HER2/neu.

Cancer vaccines typically target some protein or antigen expressed on cancer cells, he noted. "The idea is to train the immune system to recognize that protein or piece of protein that's highly expressed on cancer cells, but not on normal cells," he said. "That way the immune system can differentiate what's abnormal and normal. If the immune system can recognize it, it marks it for death, basically."

The cancer vaccine concept has been around for a long time, Peoples noted, but the team here has adopted a different approach to test their effectiveness. The vast majority of vaccines in the past were tested on end-stage cancer patients, he explained. However, a vaccine is meant to stimulate the immune system, and a healthy immune system isn't typically seen in someone in the last stages of cancer.

As a result, "a lot of early cancer vaccines tested ... in end-stage patients were found not to be helpful," Peoples said. "No real surprise there."

To more appropriately gauge the vaccine's effectiveness, Peoples' team decided to test it among patients who have a healthy immune system -- cancer survivors who are disease-free but at risk for recurrence. Experts can predict recurrence based on several factors including family history, age, size of tumor and the presence of involved lymph nodes, among other indicators.

The researchers targeted the HER2/neu protein, which is expressed at varying levels in women with breast cancer, then honed in on the 60 percent of women who express the protein at low to intermediate levels. The vaccine is a mix of the E-75 peptide of the HER2 protein and an immune system stimulant.

They started with a 200-patient trial in 2001 and followed each woman for five years. Half of the women received the vaccine -- one injection a month for six months -- and the other half was the control group.

The outcome was very promising, Peoples noted. The recurrence rate among the women in the control group was 20 percent, and 10 percent among the women who received the vaccine. "We cut recurrence in half," he said.

This success led to the next phase of testing, the colonel said, which will begin early this year and involve 700 to 1,000 patients.

Unlike the earlier phases, however, this step will be undertaken by a commercial company, Galena Biopharma, which has the resources and manpower to undertake such a large-scale test. The company will seek FDA approval and, if received, release the vaccine for public use.

This phase will take about five years to complete -- two years to enroll, then a three-year observation period, Peoples said.
"The end point is the recurrence rate after three years," he explained.

Meanwhile, Peoples and his team will turn their attention to a multitude of other projects, many based on the same concept that made the E-75 vaccine so successful -- using the body's own immune system to destroy cancer cells.

They've already taken the same vaccine and completed a trial with prostate cancer survivors. As with ovarian and lung cancer, prostate cancer also expresses the HER2 protein.

Peoples said he's also intrigued by a successful trial they conducted on breast cancer survivors who express the HER2 protein at the highest levels, rather than the low to intermediate levels they focused on before. In this study, they combined their vaccine with the drug Herceptin.

They conducted a small trial with 60 women, Peoples said, and when they administered the vaccine and Herceptin together, the recurrence rate dropped to zero. "The preliminary data is very exciting," he said. "But we need to wait and do larger trials."

Word has spread of the cancer vaccine program's successes and intriguing results. Military and civilian experts have approached Peoples wanting to take part in research that has such a potentially widespread impact. The idea of active, specific immunotherapy -- engaging the body's immune system to do the work of fighting the cancer -- is an exciting and rapidly evolving area, Peoples explained.

Garnering this interest, Peoples has steadily built a worldwide network of military and civilian hospitals that can assist with clinical trials and research. The network includes just about every major military hospital alongside a civilian hospital in cities across the nation and overseas.

The partnership has reached Athens, Greece, and is about to extend into Malaysia. "We're about to circle the globe," he said.

Peoples attributed much of the program's successes to this military-civilian network. "We're very fortunate to have great partners," he said.

He also praised the military men and women willing to take part in the trials. They enter into them knowing they may be part of the control group that doesn't receive a potentially lifesaving vaccine. Despite that fact, he hasn't seen a shortage of willing participants, Peoples said.

"The military is an ideal setting for clinical trials," he said.

Service members, retirees and family members have a strong sense of service, he noted. "They want to be involved and contribute to the research," he added.

While they're focusing on secondary cancer prevention, the ultimate goal, Peoples noted, is primary prevention, meaning cancer prevention among people with a predicted risk of cancer based on family history and genetic markers.

"Hopefully, sometime in my lifetime we'll figure that out," he said.

By Elaine Sanchez
American Forces Press Service

FDA approves vaccines for the 2011-2012 influenza season

2011-07-19T21:16:00.000-04:00

The U.S. Food and Drug Administration announced today that it has approved the 2011-2012 influenza vaccine formulation for all six manufacturers licensed to produce and distribute influenza vaccine for the United States.

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory disease caused by influenza viruses. The vaccine formulation protects against the three virus strains that surveillance indicates will be most common during the upcoming season and includes the same virus strains used for the 2010-2011 influenza season.

On average, between 5 percent and 20 percent of the U.S. population develops influenza each year, leading to more than 200,000 hospitalizations from related complications, according to the U.S. Centers for Disease Control and Prevention (CDC). Influenza-related deaths vary yearly, ranging from a low of about 3,000 to a high of 49,000 people.

“Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “It is important to get vaccinated every year, even if the strains in the vaccine do not change, because the protection received the previous year will diminish over time and may be too low to provide protection into the next year.”

In addition to the important role that health care providers play in recommending influenza vaccination for their patients, influenza vaccination of health care personnel is also important to protect themselves, their patients, their family, and the community from influenza. The FDA urges health care organizations to encourage their members to follow CDC’s Advisory Committee on Immunization Practices (ACIP) recommendations to get vaccinated.

The brand names and manufacturers of the vaccines for the upcoming season are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone, Fluzone High-Dose and Fluzone Intradermal, Sanofi Pasteur Inc. Fluzone Intradermal, approved on May 9, 2011, will be available for those ages 18 years through 64 years. This vaccine is delivered into the skin, rather than the muscle, using a very small needle.

Each year, experts from the FDA, World Health Organization, CDC, and others in the public health community study virus samples and patterns collected worldwide to identify virus strains likely to cause the most illness during the upcoming influenza season. Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the strains selected for the 2011-2012 influenza season are:

• A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)

• A/Perth /16/2009 (H3N2)-like virus

• B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.CDC’s ACIP recommends that everyone 6 months of age and older receive an annual influenza vaccination. Additional information on the ACIP recommendations can be found at: http://www.cdc.gov/media/pressrel/2010/r100224.htm

Information Sessions about Kaiser Permanente Corporate Run/Walk & Fitness Program Scheduled

2011-06-06T20:51:00.002-04:00

A series of information sessions about the Kaiser Permanente Corporate Run/Walk & Fitness Program have been scheduled around the metro Atlanta area at a variety of locations to inform the general public, recruit participants and raise awareness about the program. The sessions are free, open to the public, and feature refreshments, giveaways, prize drawings, and the opportunity to meet Olympian Jeff Galloway.

Tuesday, June 7, 7:30-9 a.m., Jason’s Deli - Midtown

230 10th St NE, Atlanta, GA 30309
Tuesday, June 14, 8-11 a.m., Jason’s Deli – Midtown – Corporate Wellness Seminar

(free to all team captains who have signed up their companies by June 10)

230 10th St NE, Atlanta, GA 30309
Thursday, June 23, 6-8 p.m., LeasePlan USA

1165 Sanctuary Parkway, Alpharetta, GA 30009
Wednesday, July 13, 6-8 p.m., Waffle House, Inc.

5986 Financial Dr., Norcross, GA 30071
Thursday, July 28, 6-8 p.m., Decatur Square – Team Decatur Kickoff

About the Kaiser Permanente Corporate Run/Walk & Fitness Program

The Kaiser Permanente Corporate Run/Walk & Fitness Program is a unique workplace-organized fitness program that began in 1983 in Atlanta with 900 participants from a handful of companies. Designed to inspire fun, fitness and camaraderie among Atlanta’s corporate community, the annual event attracts more than 15,000 participants from more than 350 companies and is one of the largest workplace organized corporate fitness events in the Southeast. Event highlights of the 29th run/walk event include Get Active Atlanta 8-week Training Promotion powered by Phidippides, 5K corporate run/walk, Best Self Atlanta Magazine Expo, free team and candid photos, awards ceremony and the World’s Largest Office Party in downtown Atlanta adjacent to Turner Field. A portion of the proceeds benefits the Atlanta Braves Foundation and the Atlanta Community Food Bank. For more information, visit www.kpcorporaterunwalk.com.

WHAT: Kaiser Permanente Corporate Run/Walk & Fitness Program

TRAINING: 8-week “Get Active Atlanta” Training Promotion - included with registration

July 18 – Sept. 8
5K CORPORATE RUN/WALK
& COMPANY PICNIC : September 8, 2011, 7:00 p.m., Downtown Atlanta, Turner Field
REGISTRATION: www.kpcorporaterunwalk.com

Online: Now through September 7, 2 p.m.

Mail: Now through September 2

In-person: September 1-7, 2 p.m. (at Phidippides running/walking stores)

In addition to eighth year title sponsor Kaiser Permanente, other sponsors for this year’s Corporate Run/Walk & Fitness Program include Dasani Water, Powerade, DAVE FM, 680 The Fan Sports Radio, Best Self Atlanta magazine, Clear Channel Outdoor, CW 69 and Phidippides Running Stores.

Follow us on Facebook and Twitter:
Facebook: facebook.com/KPCorporateRunWalk Twitter: twitter.com/kpcorprunwalk

FDA approves treatment for Clostridium difficile infection

2011-05-27T16:41:00.000-04:00

The U.S. Food and Drug Administration today approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea and lead to colitis, other serious intestinal conditions, and death in severe cases. C. difficile bacteria are found in the stool of an infected person, and others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouths.

The safety and efficacy of Dificid were demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.

“In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C. difficile infection,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea.”

Dificid, a macrolide antibacterial, should be taken two times a day for 10 days with or without food.

To maintain the effectiveness of Dificid, and to reduce the development of drug-resistant bacteria, the drug should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.

The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea.

People at risk of developing the bacterial infection include the elderly, patients in hospitals or nursing homes, and people taking antibiotics for another infection. The most effective way to prevent CDAD is thorough handwashing with soap and warm water.

Dificid was developed by San Diego-based Optimer Pharmaceuticals Inc.

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FDA Clears First Test for Recent Infection With Toxoplasmosis Parasite

2011-05-19T10:57:00.000-04:00

/PRNewswire/ -- On May 18, the U.S. Food and Drug Administration cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis, sometimes known as cat scratch disease, developed the infection within the past four months.

Toxoplasmosis is caused by the parasite Toxoplasma gondii. The infection can cause serious health problems in people with compromised immune systems. Women who become infected just before or during pregnancy may pass the parasite on to their unborn child, resulting in miscarriage, stillbirth, or an abnormally small or large head. Infection can also lead to vision loss, mental disability, seizures or other health problems later in life for the child.

Cats are most often associated with the parasite, but many other species of animals and birds also serve as hosts. The parasite also is found in people worldwide. Common symptoms of toxoplasmosis include swollen lymph nodes and flu-like symptoms.

Toxoplasmosis is considered to be a leading cause of death attributed to foodborne illness, according to the Centers for Disease Control and Prevention. More than 60 million people in the United States may be infected with Toxoplasma gondii. The parasite may be transmitted to people when they eat raw, undercooked or contaminated meat or come in contact with infected cat feces or litter.

The VIDAS TOXO IgG Avidity assay can be used to rule out recent Toxoplasma gondii infection. The test works by detecting how strongly IgG avidity antibodies bind to the Toxoplasma gondii antigens in the assay. IgG avidity antibodies from infections older than four months bind tightly with the antigens, while IgG avidity antibodies from infections acquired in the past four months form weaker bonds.

"Toxoplasmosis can have serious and lasting health consequences for infants that acquire the infection in the womb," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA's Center for Devices and Radiological Health. "This test gives doctors an additional tool to determine if women with confirmed cases of toxoplasmosis acquired the infection before or during pregnancy."

The VIDAS TOXO IgG Avidity Assay test is for use in people who have been confirmed with the Toxoplasma gondii infection by using the VIDAS TOXO IgG II test and who are pregnant or have swollen lymph glands. The VIDAS TOXO IgG Avidity Assay test alone should not be used as a basis for clinical decisions.

The performance of the VIDAS TOXO IgG Avidity Assay has not been established for prenatal screening, for immunocompromised patients, or for cases of toxoplasmosis reinfection or relapse, and the FDA has not cleared or approved the VIDAS TOXO IgG Avidity Assay for blood or plasma donor screening.

The VIDAS TOXO IgG Avidity assay is manufactured by bioMerieux Inc. of Hazelwood, Mo.

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New Shoulder Surgery Successfully Treats Serious Injuries

2011-05-19T09:43:00.000-04:00

A surgeon at the Emory Sports Medicine Center has helped to pioneer a surgical option for people suffering from severe shoulder injuries.

Spero Karas, MD, Emory orthopaedic surgeon and team doctor for the Atlanta Falcons, has found safe and effective results using a procedure called the “Bridge Technique” for rotator cuff injuries. This procedure uses a skin graft that is surgically attached to both the deficient tendon and bone to ‘bridge’ the defect.

“We have a number of treatments available to fix most rotator cuff injuries, but there are times when the tendon defect is so severe that those options are inadequate,” says Karas, who is also an associate professor of orthopaedics at Emory University School of Medicine.

For individuals with severe injuries that were untreatable in the past, this is a procedure that now offers a potential alternative.

"When the rotator cuff is repaired using this technique, it reestablishes normal function of the rotator cuff," Karas explains. "This results in eliminating pain, improving function and potentially slowing the progression of arthritis."

Not only does this procedure offer help for patients who may never have been able to completely recover from a serious injury, but Karas says it also may give the patient the ability to return to normal activity.

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FDA approves new treatment for rare type of pancreatic cancer

2011-05-09T19:30:00.002-04:00

On Thursday, the U.S. Food and Drug Administration approved Afinitor (everolimus) to treat patients with progressive neuroendocrine tumors located in the pancreas (PNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the United States each year.

“Patients with this cancer have few effective treatment options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”

The safety and effectiveness of Afinitor was established a clinical trial in 410 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease. Patients in the study were selected to receive Afinitor or placebo (sugar pill). The trial was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).

In patients treated with Afinitor, the median length of time they lived without the cancer spreading or worsening was 11 months compared with 4.6 months in patients who received placebo. Patients who received placebo were able to receive Afinitor if their disease worsened.

In patients treated with Afinitor for neuroendocrine pancreatic tumors, the most commonly reported side effects included inflammation of the mouth (stomatitis), rash, diarrhea, fatigue, swelling (edema), stomach (abdominal) pain, nausea, fever, and headache.

Afinitor is also approved to treat patients with kidney cancer (advanced renal cell carcinoma) after they fail treatment with Sutent (sunitinib) or Nexavar (sorafenib); and patients with subependymal giant cell astrocytoma (a type of brain cancer) associated with tuberous sclerosis (a disease that causes tumors in various parts of the body), who cannot be treated by surgery.

Afinitor has another trade name, Zortress, and is approved to treat certain adult patients to prevent organ rejection after a kidney transplant. Zortress has a different safety profile in these patients.

Afinitor is marketed by East Hanover, N.J.-based Novartis.

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FDA approves new treatment for Type 2 diabetes

2011-05-03T14:31:00.002-04:00

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.

People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “It is effective when used alone or when added to existing treatment regimens.”

Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.

Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.

Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.

Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

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A Little Belly Fat Can Double the Risk of Death in Coronary Artery Disease Patients

2011-05-03T14:20:00.000-04:00

(BUSINESS WIRE)--One of the largest studies of its kind has found that people with coronary artery disease who have even a modest beer belly or muffin top are at higher risk for death than people whose fat collects elsewhere. The effect was observed even in patients with a normal Body Mass Index (BMI). The findings of this Mayo Clinic analysis are published in the May 10 issue of the Journal of the American College of Cardiology.

Researchers analyzed data from 15,923 people with coronary artery disease involved in five studies from around the world. They found that those with coronary artery disease and central obesity, measured by waist circumference and waist-to-hip ratio, have up to twice the risk of dying. That is equivalent to the risk of smoking a pack of cigarettes per day or having very high cholesterol, particularly for men.

The findings refute the obesity paradox, a puzzling finding in many studies that shows that patients with a higher BMI and chronic diseases such as coronary artery disease have better survival odds than normal-weight individuals.

“We suspected that the obesity paradox was happening because BMI is not a good measure of body fatness and gives no insight into the distribution of fat,” says Thais Coutinho, M.D., the study’s lead author and a cardiology fellow at Mayo Clinic. “BMI is just a measure of weight in proportion to height. What seems to be more important is how the fat is distributed on the body,’’ she says.

Francisco Lopez-Jimenez, M.D., the project’s lead investigator and director of the Cardiometabolic Program at Mayo Clinic, explains why this type of fat may be more harmful: “Visceral fat has been found to be more metabolically active. It produces more changes in cholesterol, blood pressure and blood sugar. However, people who have fat mostly in other locations in the body, specifically, the legs and buttocks, don’t show this increased risk.”

The researchers say physicians should counsel coronary artery disease patients who have normal BMIs to lose weight if they have a large waist circumference or a high waist-to-hip ratio. The measure is very easy to use, Dr. Coutinho says: “All it takes is a tape measure and one minute of a physician’s time to measure the perimeter of a patient’s waist and hip.”

The research subjects were diverse, coming from studies in the U.S. (Rochester, Minn. and San Francisco, Calif.), Denmark, France and Korea. The inclusion of different ethnic groups makes the study more applicable to the real world, Dr. Coutinho says.

Other members of the research team are Kashish Goel, M.D.; Daniel Correa de Sa, M.D.; Randal Thomas, M.D.; Veronique Roger, M.D., MPH; and Virend Somers, M.D., Ph.D., of Mayo Clinic; Charlotte Kragelund, M.D., Ph.D.; Lars Kober, M.D., Ph.D.; and Christian Torp-Pedersen, M.D., Ph.D., from Rigshaspitalet, Copenhagen, Denmark; Alka Kanaya, M.D. of the University of California, San Francisco, California; Jong-Seon Park, M.D.; Sang-Hee Lee, M.D.; and Young-Jo Kim, M.D., of Yeungnam University Hospital, Daegu, Korea; and Yves Cottin, M.D., Ph.D.; and Luc Lorgis, M.D., from CHU Bocage, Dijon, France.

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Protein Inhibitor May Bring a Topical Treatment for HPV

2011-04-29T10:02:00.000-04:00

/PRNewswire/ -- Human papillomavirus (HPV) causes cervical cancer, the second most common cause of cancer death for women, and is a common cause of anogenital and some head and neck cancers. Thanks to research being done at Tufts University School of Medicine, patients infected with cancer-causing HPV may someday have an alternative to surgical and harsh chemical treatments. In a study funded by the National Institutes of Health and published online in advance of print in The FASEB Journal, the researchers report on the development of a protein-based inhibitor that could provide a topical treatment for HPV.

"Currently, there is no cure for HPV, and the available treatment options involve destroying the affected tissue. We have developed a protein inhibitor that blocks HPV protein expression in cell culture, a first step toward a topically-applied treatment for this cancer-causing virus," said senior author James Baleja, Ph.D., associate professor of biochemistry at Tufts University School of Medicine (TUSM) and member of the biochemistry program faculty at the Sackler School of Graduate Biomedical Sciences at Tufts.

"Vaccines are helping to lower the incidence of HPV, but vaccines will not help the millions of women and men who currently have an infection, especially those who have high-risk and persistent infections. Social and economic challenges make widespread administration of a vaccine difficult, particularly in developing countries. A topical treatment for HPV could provide an economical option," he continued.

HPV affects approximately 20 million people in the United States, making it the most common sexually transmitted infection. There are more than 100 types of HPV of which more than 40 are sexually transmitted. These include two high-risk types, HPV-16 and HPV-18, which cause the majority of cervical and anogenital cancers, and some portion of head and neck cancers, particularly oral cavity and oropharynx cancers. Cervical cancer is diagnosed in nearly 500,000 women each year, killing 250,000 annually. In the United States, it was estimated that 12,000 women in 2010 would be diagnosed with cervical cancer, while 10,100 women and men in the United States get vulvar, vaginal, penile or anal cancers each year. In addition, some portion of the head and neck cancers in the United States (11,300 men and women each year) is attributable to HPV. Other types of HPV, or low-risk HPV, can cause genital warts or are infections that clear on their own.

In their efforts to inhibit HPV, Baleja and his team zeroed in on the viral protein E2, which controls viral activities including DNA replication and the activation of cancer-causing genes. Using structure-guided design, the team developed a protein called E2R that prevents E2 from functioning normally. When the researchers applied E2R to a cell model of HPV biology, viral gene transcription was halted. Because HPV infects epithelial cells, the outermost layer of the skin and the mucous membranes, protein inhibitors such as E2R could be applied in a topical form.

Baleja and colleagues used biophysical tools including circular dichroism spectroscopy and x-ray crystallography to test the structure and stability of different inhibitors. The most stable inhibitor was then tested in mammalian cells and was found to inhibit the E2 protein of HPV-16, the high-risk strain that is most commonly associated with cancers. The data in this study suggest that the inhibitor may also be effective against another high-risk virus, HPV-18, as well as a low-risk virus, HPV-6a, which causes warts.

Additional authors on the paper are first author Kakoli Bose, Ph.D., formerly a postdoctoral fellow in the Baleja laboratory at TUSM and now with the Advanced Centre for Treatment, Research and Education in Cancer at the Tata Memorial Center in India; Gretchen Meinke, Ph.D., senior research associate in the Bohm Laboratory at TUSM, and Andrew Bohm, associate professor in the Department of Biochemistry at TUSM and member of the biochemistry program faculty at the Sackler School of Graduate Biomedical Sciences.

This research was funded by the National Cancer Institute, part of the National Institutes of Health, and by the Lifespan/Tufts/Brown Center for AIDS Research (CFAR), a joint research effort between Tufts and Brown Universities and their affiliated hospitals and centers. CFAR is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Bose K, Meinke G, Bohm A, and Baleja J. The FASEB Journal. "Design and characterization of an enhanced repressor of human papillomavirus E2 protein." Published online April 11, 2011. DOI 10.1096/fj.10-176461

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Emergency Visits Are Increasing, New ACEP Poll Finds; Many Patients Referred By Primary Care Doctors

2011-04-28T13:29:00.000-04:00

/PRNewswire/ -- More than 80 percent of emergency physicians responding to an ACEP poll said emergency visits are increasing in their emergency departments, with half reporting significant rises, and more than 90 percent expecting increases in the next year. Almost all (97 percent) reported treating patients on a daily basis who were referred to them by primary care doctors, going against a widely-held assumption that people are choosing to go to the emergency department instead of seeking primary care.

At the same time, 97 percent of emergency physicians also report treating Medicaid patients on a daily basis who could not find any other doctor to accept their health insurance. If the new health care reform legislation provides insurance coverage that reimburses doctors at Medicaid rates, this could exacerbate a lack of access to medical care.

"This poll confirms what we are witnessing in Massachusetts — that visits to emergency rooms are going to increase across the country, despite health care reform, and that health insurance coverage does not guarantee access to medical care," said Dr. Sandra Schneider, president of the American College of Emergency Physicians. "Emergency medicine provides lifesaving and critical care to millions of patients each year and yet only represents 2 percent of the nation's health care expenditures. Emergency physicians command the resources of a hospital to provide the best care for patients, but we must be prepared for increasing numbers of patients, not fewer, especially given our growing elderly population."

ACEP conducted the poll from March 3 to March 11, 2011. E-mails were sent to 20,687 emergency physicians, and 1,768 responded. The survey has a theoretical sampling error range of plus/minus 2.23.

While 79 percent of responding emergency physicians said their emergency departments use resources efficiently, nearly half of respondents (44 percent) said the fear of lawsuits was the biggest challenge to cutting emergency department costs. More than half (53 percent) of emergency physicians reported that fear of lawsuits is the main reason for ordering the number of tests they do.

"Emergency departments need more resources, not fewer, and medical liability reform would help reduce overall costs by reducing the need for defensive medicine," said Dr. Schneider.

Two-thirds of emergency visits occur after business hours, when doctor's offices are closed and patients have nowhere else to turn. Visits to ERs reached an all-time high of nearly 124 million in 2008, according to the Centers for Disease Control and Prevention (CDC) and are expected to rise nationwide.

Physicians responding to the poll attribute the overall increase in emergency patients to patients without health coverage (28 percent) and a growing elderly population (23 percent) are seen by physicians as the most important reasons for the overall increase in ER patients.

An overwhelming 89 percent of physicians believe the number of visits to the emergency department will increase as health care reforms are implemented with 54 percent of them expecting to see a significant increase.

"Emergency visits have increased at twice the rate of the U.S. population, and less than 8 percent of those patients have nonurgent medical conditions, meaning the vast majority need to be there," said Dr. Schneider. "At the same time, hundreds of emergency departments have closed. The new health care reform law does not address these problems and with the elderly population and more emergency departments forced to shut down, this crisis will only get worse."

More than 1,400 (82.5 percent) responding to the poll said that lives were saved every day in their emergency departments. "Emergency medicine is critical at any hour of the day. It must be there when you need it," said Dr. Schneider.

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Free Oral, Head and Neck Cancer Screenings at Emory

2011-04-27T16:44:00.002-04:00

Oral Head and Neck Cancer Awareness Week

In support of Oral, Head and Neck Cancer Awareness Week, Emory Healthcare will be offering free oral head and neck cancer screenings at the Emory Clinic on Friday, April 29 from 1-4 pm, and on Wednesday, May 4 from 8 am to noon.

According to the American Cancer Society, head and neck cancers represent the sixth most common form of cancer in the United States, with more than 50,000 cases diagnosed annually, and over 12,000 deaths.

Screenings on Friday, April 29, will take place in the Oral Surgery Department of Clinic B, 1365-B, Clifton Rd., 2nd floor. Screenings on Wednesday, May 4, will take place in the ENT Department, 1365-A Clifton Rd., 2nd floor. Screenings are first come first served.

Study Suggests an Alternative to Foot Amputation for Some Diabetic Patients

2011-04-27T11:38:00.000-04:00

/PRNewswire/ -- A recent study published in the March issue of Foot & Ankle International (FAI), the official scientific journal of the American Orthopaedic Foot & Ankle Society (AOFAS) describes a possible amputation alternative for patients with neuropathic ulceration of the first metatarsophalangeal (MTP) or big toe joint. The findings are noteworthy as diabetes is the leading cause for non-accident/injury leg and foot amputations among US adults, with more than 60,000 lower extremity amputations performed annually. In addition, neuropathy (nerve damage or loss of feeling) of the foot occurs in 60-70% of diabetic patients.

The study's alternative operative treatment to amputation includes debridement and resection arthroplasty with temporary external fixation and VAC dressing. Nicholas Smith, corresponding author of the study says, "While the study includes only a small sample, it does represents the largest group followed in literature. Given that patients are very satisfied with the outcomes and that we achieved an equally positive end point compared to more radical amputation, we are hopeful that this option will be considered for select patients in the future."

The retrospective study examined 16 patients (the largest group followed in the literature) who underwent resection arthroplasty with external fixation for first MTP ulceration. The patients were studied post-operatively for an eight year period. The purpose of the study was to obtain information on long-term outcomes for all patients who underwent the procedure. Ten out of 16 patients were ulcer free at the conclusion of the study and required no further surgery. The remaining six patients required a secondary procedure which required amputation.

Treatment includes complete debridement of the infected tissue, application of external fixator with pins and wires, and 6 to 8 weeks of antibiotics with use of negative pressure wound therapy (NPWT) for the postoperative treatment of open wounds

The findings are noteworthy for diabetic patients with foot ulcerations. The authors of the study feel the procedure warrants consideration in the treatment of deep forefoot ulcerations, yet concede that if the ulceration fails to heal, amputation may be the only viable option.

For more information on diabetic foot as well as resources on foot and ankle care, visit the AOFAS website, www.aofas.org. The site also features a surgeon referral service that makes it easy for patients to find a local orthopaedic surgeon specializing in foot and ankle care.

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UGA researchers develop non-invasive early diagnostic test for gastric cancer

2011-04-27T10:41:00.000-04:00

Early detection of cancer may eventually become as easy as taking a home pregnancy test, according to new University of Georgia research.

Two studies recently published in the journal PloS ONE identified for the first time that certain proteins excreted in urine can indicate the presence of gastric cancer.

The researchers initially studied stomach cancer because it is the number two cancer killer in the world.
They hope that with further study, the detection of abnormally abundant proteins in urine will lead to diagnosis of many types of cancer and other diseases, said Ying Xu, lead author of the study and Regents-Georgia Research Allianceeminent scholar of bioinformatics and computational biologyin the UGA Franklin College of Arts and Sciences.

“In theory, the methodology that we developed should be applicable to other cancers,” said Xu, who also is a professor of biochemistry and molecular biology and director of the UGA Institute of Bioinformatics.

Xu and his colleagues, Celine Hong, Juan Cui and David Puett of the Institute of Bioinformatics, identified a protein called endothelial lipase that differed significantly in its abundance in urine samples of stomach cancer patients versus healthy people. Xu said the computational capability presented in the study for predicting which of the abnormally abundant proteins in diseased tissues can be excreted into urine is a key breakthrough in cancer detection. Using samples from already known excretory and non-excretory proteins, the study found that the classification system was more than 80 percent accurate.

Of the 21 urine samples of healthy people, only two did not have the protein. In the 21 urine samples of stomach cancer patients, only one sample was considered to have a relatively high level of the protein; levels in the rest were low or absent. “We are suggesting from this relatively small urine sample set that healthy people should have this protein in their urine,” Xu said.

The researchers are currently working on a larger urine sample set of 200 gastric cancer patients and 200 healthy people. “If the EL protein still has the 10 to 15 percent miscalculation rate as with the 21 versus 21 samples, I think we have found a good diagnostic marker for stomach cancer and potentially other cancers,” said Xu.

Now that the researchers have identified a protein marker, Xu says they should be able to develop a method where urine can change the color of a piece of paper to indicate the presence or absence of the protein, similar to the way a home pregnancy test works. The researchers hope to find multiple protein markers for each cancer to increase the accuracy of the test.

Although the test is not yet 100 percent accurate, it can lead at-risk patients to seek a more comprehensive exam, said Xu. Current procedures such as endoscopy are invasive, uncomfortable and may be avoided by many people. “A person could go get a urine test, and if the marker protein is present, then they are generally stomach-cancer free,” said Xu. “If the protein is not present, we might suggest that they get their stomach checked.”

The researchers began by studying a set of 1,500 proteins known to be excreted in urine and identified a list of features that distinguish them from proteins that are not excreted into urine. Identifying these distinguishing features allowed them to develop a classification system that could predict which proteins in cancerous tissues are excreted into urine.

Xu and his colleagues then used microarrays—chips that are about the size of a stamp that contain nearly twenty thousand human genes—to identify which proteins varied in abundance in the cancerous versus non-cancerous tissues. Messenger RNA (mRNA) molecules extracted from the sample tissues are converted to complementary DNAs (cDNAs) and hybridize with their complement genes on the microarray and light up as spots when the corresponding mRNAs are abundant. The researchers then identified proteins corresponding to those genes that appeared at significantly different levels in the cancer and non-cancer samples. From there, the researchers were able to determine which of the abnormally abundant proteins were secreted into the blood and then excreted in urine using the classification method they developed.

The UGA researchers work in conjunction with a team of researchers led by Fan Li of Jilin University in China, where Xu spends two months a year working with medical doctors and researchers on sample collection and carrying out microarray experiments. This long-term collaboration has led to the establishment of the Jilin University/University of Georgia Joint Research Center for Systems Biology. The researchers are currently collecting tissues from patients with different types of cancer to identify more protein markers that can be detected in urine.

The study was supported by the UGA President’s Venture Fund, the Office of Vice President for Research, the Georgia Cancer Coalition, the Georgia Research Alliance, Jilin University and the National Institutes of Health.

To learn more about the UGA Institute of Bioinformatics, see http://www.bioinformatics.uga.edu/. To learn more about the Franklin College of Arts and Sciences department of biochemistry and molecular biology, see http://www.bmb.uga.edu/.

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Streptococci and E. coli Continue to Put Newborns at Risk for Sepsis

2011-04-25T11:13:00.000-04:00

Bloodstream infections in newborns can lead to serious complications with substantial morbidity and mortality. What’s more, the pathogens responsible for neonatal infections have changed over time. In recent years, however, antibiotic prophylaxis given to at-risk mothers has reduced the incidence of early-onset group B streptococcal infections among their babies.

A new nationwide, multi-site study aimed at determining current early-onset sepsis rates among newborns, the pathogens involved, and associated morbidity and mortality demonstrates that the most frequent pathogens associated with sepsis are group B streptococci (GBS) in full-term infants and Escherichia coli in preterm infants.

The study, which included nearly 400,000 newborns, also found that infection rates in newborns increased with decreasing gestational age and birth weight. The overall rate of infection was 0.98 per 1,000 live births; 0.41 per 1,000 live births involving GBS and 0.28 per 1,000 live births involving E. coli.

The study appears online April 25 and in the May 2011 issue of Pediatrics.

GBS emerged as the leading cause of early-onset sepsis and meningitis in newborns in the 1970s. In 2002, the Centers for Disease Control and Prevention recommended universal screening of women at 35 to 37 weeks of pregnancy followed by chemoprophylaxis for women with GBS colonization.

Sepsis occurs when pathogenic bacteria enter the blood stream, causing systemic infection. In infants less than 72 hours old, sepsis is considered of early onset.

“Infections occur in almost one case per thousand live births,” says Barbara Stoll, MD, lead investigator for the study. Stoll is the George W. Brumley, Jr., Professor and Chair, Department of Pediatrics in Emory University School of Medicine. “With approximately 4 million births a year in the United States, this equates to a substantial burden of disease. We estimate that approximately 3,000 infants a year develop early-onset sepsis. With current mortality rates, approximately 300 to 350 deaths per year are associated with neonatal sepsis. So, it’s not inconsequential.”

The study also shows that opportunities for prevention of neonatal GBS infections continue to be missed. “Missed opportunities for prevention of GBS include failure to screen all women who deliver at term, failure to provide antibiotics to all colonized women or to those who delivered preterm with unknown colonization status and false negative GBS screens among women who deliver with GBS infection,” says Stoll.

“Our findings suggest that accurate point-of-care diagnostic tests at the time a woman comes in for delivery would enhance our ability to identify at-risk women.”

In addition, the gap in linking electronic medical records between a woman’s obstetrician and the hospital where she delivers can also impede prevention. “A community health record that links the medical record in a physician’s office with the hospital where the woman gets care could enhance identification and therapy for at-risk women,” says Stoll. “If a woman has been screened for GBS and is known to be colonized, that information should be available to the health care team taking care of her at the time she is in labor.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Centers for Disease Control and Prevention.

By Robin Tricoles

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FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers

2011-04-25T10:36:00.000-04:00

The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

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UGA compound offers new hope for treatment of painful adult shingles

2011-04-22T11:53:00.000-04:00

Researchers at the University of Georgia and Yale University have discovered a compound with the potential to be more effective than existing agents in treating the very painful blisters known as shingles—a condition that affects up to 30 percent of Americans, mostly elderly, and for which no specific treatment exists.

Most adults remember the fever, itchy blisters and possibly tiny scars they experienced as children when they had chickenpox, which is caused by the varicella-zoster virus, or VZV.Unfortunately, that memory can come back—with a vengeance—when they are older. The VZV virus from childhood chickenpox hides in the nerves, emerging most frequently in adults over the age of 60 as a blistering rash on one side of the body. The rate of complications, including nerve pain that can persist for months or years after the shingles attack is gone, also increases with age.

The novel and effective anti-shingles agent called L-BHDA may change that. Rights to the shingles treatment have been licensed to Bukwang Pharmaceutical Company for preclinical investigations by the University of Georgia Research Foundation, Inc. and Yale University.

“We need new options for medications with increased potency and specificity that can treat VZV, including strains that may be resistant to existing drugs,” said medicinal chemist Chung (David) Chu, Distinguished Research Professor of Pharmaceutical and Biomedical Sciences at UGA, one of the inventors of L-BHDA.

A collaboration between Chu and co-inventor Yung-Chi (Tommy) Cheng, the Henry Bronson Professor of Pharmacology at Yale, has resulted in an extensive portfolio of antiviral compounds that target such diseases as HIV, shingles, hepatitis and cancers.

Chu, who is head of the Drug Discovery Group in the UGA College of Pharmacy, said that although there are generic antiviral drugs to reduce the duration and pain of shingles, and a variety of pain medications and topical creams to relieve long-term pain, “They are only moderately effective.We need more effective anti-VZV agents.

“L-BHDA has the potential to be more effective than existing agents,” said Chu. He noted that the new compound has been tested in the laboratory and demonstrated in mice models by a group of researchers headed by Jennifer Moffat, associate professor of microbiology and immunology, State University of New York Upstate Medical University.

A vaccine to prevent shingles, available to older adults since 2006, can cut the likelihood of a shingles attack in half. However, according to a recent study in the American Journal of Preventive Medicine, only a small percentage of older people receive the shot, principally because of cost, lack of insurance reimbursement and shortage of supply.

It is likely that immunization against chickenpox during childhood also protects against shingles, because the vaccine uses a weakened strain of the virus. However, the vaccine was only introduced in 1995, and there are not enough data to provide a definitive answer.

“Dr. Chu and Dr. Cheng have been working diligently to fill a much needed gap in the treatment options for such a prevalent disease,” said Rachael Widener, UGARF technology licensing manager. “Before the chicken pox vaccine became widely used in the mid-1990s, older, unvaccinated individuals would have their immunity boosted naturally.

“Now, with less exposure to chicken pox, shingles is becoming more prevalent,” said Widener. “This, combined with the aging baby boomer population, underscores the need for more directed treatment. We are hopeful that L-BHDA will allow patients to get well sooner and feel less pain, and will lessen their chances of complications.”

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FDA approves Rituxan to treat two rare disorders

2011-04-20T09:36:00.000-04:00

The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Rituxan is an antibody that is manufactured through biotechnology methods. The drug works by greatly reducing the number of specific immune cells in the blood, known as B cells.

The safety and effectiveness of Rituxan was demonstrated in a single controlled trial, in which 197 patients with WG or MPA were assigned at random to receive either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared to 53 percent of patients treated with cyclosphosphamide.

Retreatment with Rituxan was not formally evaluated; therefore, the safety and efficacy of retreatment with subsequent courses of Rituxan has not been established. More data are needed to determine the safety of more than one course of Rituxan and long term safety of use of Rituxan in patients with WG and MPA. These questions will be further evaluated in a required post-marketing study.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth (severe mucocutaneous reactions); and progressive multifocal leukoencephalopathy, a brain infection that generally is fatal. Rituxan is not recommended for use in patients with severe, active infections.

The most common side effects in study participants with WG and MPA included infection, nausea, diarrhea, headache, muscle spasms, and anemia.

Rituxan, which has been marketed since 1997, is also indicated for the treatment of patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

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FDA approves Actemra to treat rare form of juvenile arthritis

2011-04-18T10:54:00.000-04:00

The U.S. Food and Drug Administration today approved Actemra (tocilizumab), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children ages 2 years and older.

SJIA, or Still’s disease, is a rare, potentially life-threatening disorder in children that causes severe inflammation throughout the body. SJIA is distinguished from other forms of juvenile idiopathic arthritis (JIA) by the prominence of systemic and inflammatory features, including spiking fevers; rash; swelling and inflammation of lymph nodes, liver, and spleen; and high white blood cell and platelet counts. The prevalence of JIA is an estimated 1 to 2 per 1,000 children, and SJIA affects about 10 percent of all JIA patients.

Actemra is an interleukin-6 receptor blocker approved by the FDA on Jan. 8, 2010, for treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to other approved therapies.

“This new indication of Actemra provides the first approved therapy for children with this rare disease,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

An international, multicenter controlled trial demonstrated the safety and effectiveness of Actemra, in which 112 patients received either Actemra infusions or placebo infusions every two weeks. Study participants included patients with SJIA aged 2 to 17 years old who had inadequate response to or who were unable to take nonsteroidal anti-inflammatory drugs and corticosteroids.

Eighty-five percent of those receiving Actemra responded to treatment, compared with 24 percent of patients receiving placebo. Response was defined as at least 30 percent improvement in the American College of Rheumatology’s JIA efficacy variables, along with absence of fever in the preceding seven days. In the long-term, follow-up period of the trial there were three cases of macrophage activation syndrome (MAS) among SJIA patients receiving Actemra. MAS is a potentially fatal complication of childhood systemic inflammatory disorders, thought to be caused by excessive activation and proliferation of certain immune cells.

Actemra carries a Boxed Warning for serious infections. Patients treated with Actemra who develop a serious infection should stop Actemra treatment until the infection is controlled. A Boxed Warning is a brief, concise summary of the information that is critical for a prescriber to be aware of, including any restriction on distribution or use, which is included in a black box at the beginning of the drug label.

Changes in certain laboratory test results such as liver tests, blood counts, and cholesterol are not uncommon with Actemra and should be monitored with regular blood tests. The most common side effects in trial participants with SJIA included upper respiratory tract infection, headache, sore throat, and diarrhea.

Actemra is marketed by San Francisco-based Genentech Inc., a subsidiary of the Roche Group.

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Doctors Recommend Different Treatments for Patients Than for Themselves

2011-04-14T09:57:00.000-04:00

A patient who can't decide between two available treatments asks his doctor: "What should I do?" Another patient, torn between the same two treatments, asks: "Doctor, what would you do if you were me?"

Will those two patients get the same answer? That question, posed by researchers from Duke University and the University of Michigan in a national survey of physicians, found doctors often recommend different treatments for patients than they would choose for themselves.

The study, from professor Peter Ubel and post-doctoral associate Andrea Angott of Duke University's Fuqua School of Business and professor Brian Zikmund-Fisher of the University of Michigan, appears in the April 11 edition of the Archives of Internal Medicine. Funding for the study was provided by the American Cancer Society, the National Science Foundation and the National Institutes of Health.

In the study, the researchers conducted a randomized experiment asking some physicians to make a recommendation to a patient seeking advice, while other physicians were asked what they themselves would choose as a patient facing the same health care decision.

Doctors frequently advised patients to pursue treatments with higher rates of side effects and lower mortality rates, while choosing treatments with lower rates of side effects and higher mortality rates for themselves.

"Our research found that people felt living with a colostomy or being paralyzed was better than dying. From that perspective, the ‘right' decision is to take the risk of side effects and reduce the chances of dying," Ubel said.

However, emotions brought on by potential significant side effects often push people away from the "right" decision. Doctors -- free from the side effects of treatment -- can make more objective treatment recommendations to their patients.

"When making recommendations to patients, physicians can push aside any emotions that would lead them astray," Ubel said. "But those emotions may loom large when a doctor is deciding for him or herself. In other words, the act of giving advice to others may reset the balance between emotion and reason."

Ubel noted, "Many physicians are biased by their own backgrounds, valuing things that patients don't necessarily value, or they can even be influenced by financial and professional conflicts of interest that can skew judgment."

As a result, you might not always get the objective advice you seek, Ubel said. "Instead, the advice you get could depend on whether your doctor is thinking about what you should do, or instead thinking about what he or she would do in your situation."

A detailed report on the research is available at http://archinte.ama-assn.org/.

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FDA approves new treatment for large brain aneurysms

2011-04-14T09:23:00.000-04:00

The U.S. Food and Drug Administration has approved the cPAX Aneurysm Treatment System for surgery on brain aneurysms that are difficult to manage because of their size and shape.

An aneurysm is a bulge in the wall of a blood vessel, which can rupture as it increases in size, causing hemorrhage or death. Brain aneurysms often produce no symptoms until they grow and press on nerves in the brain, or until they begin to leak blood or rupture.

Aneurysms can be repaired in two ways: surgeons can close the base of the aneurysm with a surgical clip, or use a technique commonly known as coiling, in which surgeons use a catheter to thread metallic coils through a blood vessel in the groin and into the blood vessel in the brain that contains the aneurysm. Surgeons then fill the aneurysm with the detachable coils, which block it from circulation and cause blood to clot, effectively destroying the aneurysm.

Aneurysms larger than 10millimeters are difficult to treat with clipping or coiling. The cPAX Aneurysm Treatment System is indicated for use in those brain aneurysms.

“Like coiling, the cPAX Aneurysm Treatment System is a form of endovascular repair,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “But instead of tiny metallic coils, it uses a special polymer material to fill the space within the aneurysm.”

The cPAX polymeric filler material can be secured in the aneurysm in one of two ways, either by insertion through openings in a permanent stent, which is a tiny metal scaffold placed along the vessel wall, or by using a temporary balloon catheter to block off the opening to the aneurysm and keep the filler material from coming out of the aneurysm as it is being delivered.

By filling the bulging space within the aneurysm with implant material, the blood flow through the aneurysm is stopped and any remaining space around the implant material clots. When filled with implant material and blood clot, and the risk of rupture of the aneurysm decreases.

The cPAX Aneurysm Treatment System was approved on April 1, 2011, under a Humanitarian Device Exemption (HDE). The HDE makes medical devices available to patients with rare medical conditions that affect fewer than 4,000 people a year. The approval for this HDE was based on safety data from two studies of 43 subjects.

The cPAX device system is indicated for use in adults ages 22 and older and should not be used in patients with an active infection or in those in whom anticoagulation and antiplatelet therapy is contraindicated.

The cPAX Aneurysm Treatment System is manufactured by Neurovasx Inc., Maple Grove, Min.

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Expansion of HIV/AIDS Vaccine Program Announced by GeoVax Labs, Inc.

2011-04-11T10:58:00.000-04:00

/PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), announced today that it is expanding its preventative HIV/AIDS vaccine development effort in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN). Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-like-particles. The DNA vaccine is used to prime immune responses that are subsequently boosted by vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN.

GM-CSF is a cytokine (growth stimulating protein) that serves to expand and mature cells that initiate immune responses and has undergone extensive testing in humans for cancer vaccines. The GM-CSF-adjuvanted vaccine was added to GeoVax's portfolio because of the outstanding ability of the simian prototype vaccine to induce immune responses that prevented simian immunodeficiency virus (SIV) infection. In nonhuman primates, the GM-CSF enhanced vaccine achieved protection against SIV in 70% of the animals. Protection was measured against 12 weekly rectal challenges using a dose of SIV which is estimated to be 30 to 300 times higher than the typical exposure dose of HIV in mucosal transmission in humans.

"For years, the HIV vaccine field has been working with vaccines that elicited immune responses that primarily controlled immunodeficiency virus challenges in infected animals, but did not actually prevent infections. The ultimate goal is to prevent infections. The co-expression of GM-CSF with the SIV proteins is a vaccine design that appears to be a large step towards reaching this goal," said Dr. Harriet Robinson, Chief Scientific Officer at GeoVax. "In our trials in nonhuman primates, GM-CSF enhanced the quality of the SIV-specific antibody response. Antibody is present in blood and tissues and has the potential of blocking SIV before it infects cells. The GM-CSF-adjuvanted vaccine induced the production of antibodies characterized with increased tightness of antibody binding. The tightness of antibody binding, known as avidity, can be expressed as an index. Animals with indices above 40 were protected from infection, whereas animals with lower indices were infected with the number of challenges to infection correlating with their index."

"We are very pleased that the HVTN will be conducting trial HVTN 094 of our GM-CSF adjuvanted vaccine product, which we expect will begin late this year," said Dr. Robert McNally, CEO of GeoVax. "The HVTN, funded by the NIAID, is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. We are looking forward to working with an excellent team of HVTN trial investigators."

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FDA Permits Marketing of First Test to Help Diagnose Dengue Fever

2011-04-08T17:32:00.000-04:00

/PRNewswire/ -- The U.S. Food and Drug Administration today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.

The dengue virus is transmitted to humans by the bite of an infected Aedes mosquito. As many as 100 million people worldwide are infected by the virus each year, according to the U.S. Centers for Disease Control and Prevention (CDC).

Symptoms of dengue fever include high fever, severe headache, severe pain behind the eyes, joint pain, muscle and bone pain, rash and mild bleeding involving the nose or gums, and easy bruising.

Most reported dengue cases in the continental United States occur in people returning from travels to tourist destinations in Latin America, the Caribbean and Southeast Asia. Dengue is also endemic in the U.S. in Puerto Rico, the Virgin Islands and some U.S.-affiliated Pacific Islands. Recently, dengue outbreaks have occurred in Hawaii, Texas, and Florida.

The DENV Detect IgM Capture ELISA test detects antibodies to dengue virus in blood samples from patients who have signs and symptoms of dengue. The test will be available for use in clinical laboratories and will assist in the diagnosis of dengue, which can improve patient care and management.

The DENV Detect IgM Capture ELISA test is based on technology patented by the CDC and manufactured by Seattle-based Inbios Inc.

"Cases of dengue fever or dengue hemorrhagic fever can be potentially fatal for people who do not recognize the symptoms," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in FDA's Center for Devices and Radiological Health. "This test will now aid health care professionals in their effort to more effectively diagnose dengue."

The FDA reviewed data for the test via the "de novo" pathway, an alternative path to market for devices that are low to moderate risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a "510(k)" premarket notification.

People who believe they have dengue should immediately contact a health care professional. There are no FDA-licensed vaccines to prevent dengue and no medicines specifically approved to treat the infection.

The test should not be used in people who do not show signs or symptoms of dengue. Diagnostic testing for dengue is complicated by the fact that an IgM antibody response to the dengue virus infection is not detectable until 3-5 days after the onset of fever, which can produce a negative test result even though a person has dengue. During this "IgM negative window" the dengue virus is present in the bloodstream.

There are currently no FDA-cleared or approved tests for direct detection of dengue virus.

This new test shows cross-reaction with other closely related viruses such as those that cause West Nile disease. However, in most patient testing situations found in the United States, a positive test result in a patient with signs or symptoms consistent with dengue should be considered presumptive evidence of dengue.

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FDA approves Horizant to treat restless legs syndrome

2011-04-08T09:36:00.000-04:00

On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).

RLS is a disorder that causes a strong urge to move the legs. This urge often occurs with unpleasant feelings in the legs. People who have RLS describe feeling pulling, itching, tingling, burning, or aching in their legs, and moving the legs temporarily relieves these feelings. The urge to move often happens when a person is inactive, and the symptoms typically are worse in the evening and early morning.

“People with restless legs syndrome can experience considerable distress from their symptoms,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Horizant provides significant help in treating these symptoms.”

The effectiveness of Horizant was studied in two 12-week clinical trials in adults. The trials showed that people taking the medication had an improvement in their RLS symptoms, compared with people taking an inactive pill (placebo).

Horizant will be dispensed with an FDA-approved Medication Guide that explains the drug’s uses and risks. Horizant may cause drowsiness and dizziness and can impair a person’s ability to drive or operate complex machinery.

Horizant contains gabapentin enacarbil that becomes gabapentin, a drug used to treat seizures in people with epilepsy, when absorbed into the body. All drugs used to treat epilepsy carry warnings that they may cause suicidal thoughts and actions in a small number of people. Horizant will have the same warning.

Horizant was developed by GlaxoSmithKline of Research Triangle Park, N.C., and Xenoport of Santa Clara, Calif.

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FDA approves new treatment for rare form of thyroid cancer

2011-04-08T09:10:00.000-04:00

The U.S. Food and Drug Administration today (April 6) approved vandetanib to treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.

Thyroid cancer is a cancerous growth of the thyroid gland, which is located in the neck. Medullary thyroid cancer involves specific types of cells that are found in the thyroid gland and can occur spontaneously, or be part of a genetic syndrome.

About 44,600 new thyroid cancer cases were diagnosed in the United States during 2010, and about 1,690 people died from the disease, according to the National Cancer Institute. Medullary thyroid cancer is estimated to represent 3 to 5 percent of all thyroid cancer; its estimated incidence in the United States for 2010 is about 1,300 to 2,200 patients, making it one of the rarer forms of thyroid cancer.

Common symptoms of medullary thyroid cancer may include coughing, difficulty swallowing, enlargement of the thyroid gland, swelling of the neck, a lump on the thyroid, and changes in a person’s voice or hoarseness.

Vandetanib targets medullary thyroid cancer’s ability to grow and expand. There are currently no FDA-approved treatments for this type of cancer. Vandetanib is administered orally on a daily basis.

Vandetanib’s safety and effectiveness were established in a single, randomized international study of 331 patients with late-stage medullary thyroid cancer. Patients in the study were selected to receive vandetanib or placebo (sugar pill).

The study was designed to measure the length of time a patient lived without the individual’s cancer progressing (progression-free survival). Patients who received vandetanib had a longer period of time without disease progression when compared to patients receiving placebo. Median progression-free survival was 16.4 months in the placebo arm and at least 22.6 months in the vandetanib arm. It is too early to determine the median progression-free survival in patients treated with vandetanib or to tell whether they will live longer (overall survival) compared to patients treated with placebo.

“Vandetanib’s approval underscores FDA’s commitment to approving treatments for patients with rare and difficult to treat diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

Common side effects occurring from vandetanib use include diarrhea, rash, nausea, high blood pressure, headache, fatigue, decreased appetite, and stomach (abdominal) pain. Serious side effects reported during the study resulted in five deaths in patients treated with vandetanib. Causes of death included breathing complications, heart failure, and a bacterial infection in the blood (sepsis).

Vandetanib was shown to affect the electrical activity of the heart, which in some cases can cause irregular heart beats that could lead to death. Vandetanib is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about these serious heart-related risks. Only health care professionals and pharmacies certified through the vandetanib REMS program, a restricted distribution program, will be able to prescribe and dispense the drug. Patients will also receive an FDA-approved Medication Guide informing them of the potential risks.

Vandetanib is marketed by AstraZeneca Pharmaceuticals LP of Wilmington, Del. There is no trade name established for this drug at this time.

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Newborn Possibilities Fund Awards Grant to Georgia Health Sciences University Foundation to Support Groundbreaking Pediatric Research

2011-03-30T10:09:00.000-04:00

/PRNewswire/ -- The Newborn Possibilities Fund, a grantmaking program established by Cord Blood Registry (CBR), today announced it will provide its first-ever grant to the Georgia Health Sciences University Foundation. The university's medical center is conducting the first FDA-regulated clinical trial evaluating cord blood stem cells as a medical intervention for cerebral palsy. The grant will provide financial support to help curb travel and other expenses for families with a child participating in the trial.

The study will include 40 children, ages 1 to 12 and will begin with a neurological exam. Then, half of the study participants will receive an infusion of their own cord blood while the other half receives a placebo. Three months later, the children will be evaluated without physicians knowing which group received the stem cell infusion. Afterward, children who didn't get their cord blood initially will receive an infusion. Children in the study will return three and six months later for evaluation, where researchers will assess their motor skills and neurological development.

"This is a very well-designed clinical study that will provide new insights into the potential of cord blood stem cells to help children recover from nerve tissue damage to the brain," said Heather Brown, vice president of scientific and medical affairs at CBR. "However, the study design requires a family to make trips at their own expense to the study center. The goal of The Newborn Possibilities Fund is to remove financial barriers that may prevent eligible children from participating in this cutting-edge research and receiving investigational treatments that may improve their quality of life."

The Newborn Possibilities Fund (NPF) was created to help advance clinical research investigating the use of a child's own cord blood stem cells as a treatment for conditions like cerebral palsy and traumatic brain injury. The NPF directs financial grants to non-profit organizations to help cover the cost of travel for families who have the chance to participate in FDA-regulated trials. The Fund is administered by Tides, a public charity, on behalf of CBR.

Patients who meet the inclusion criteria and are enrolled in the trial at Georgia Health Sciences University will be notified of the Newborn Possibilities Fund and have the opportunity to receive funds to use toward the cost of travel to Augusta, Georgia for the cord blood infusion procedure and required follow up visits.

"The hope for stem cells, really from the beginning, is that they might serve as some type of replacement for cells in the nervous system that have been destroyed or never developed properly," said Dr. James Carroll, professor and chief of pediatric neurology at Georgia Health Sciences University and principal investigator on the study. "The main goal of our research is to try to help improve the lives of children with cerebral palsy and find out if the method we're using is going to help these children in the future."

A growing body of research in animals has shown that infused stem cells help to initiate repair and induce healing in the brain. While the Georgia Health Sciences University is the first controlled clinical trial to be conducted, anecdotal reports from previous studies have shown marked improvement in children with cerebral palsy about three months after an initial infusion of cord blood, which led Dr. Carroll to design his trial.

Through generous donations, the Newborn Possibilities Fund hopes to provide financial support for additional trials already underway at leading research universities across the country. For more information on the program or to donate, please visit www.newbornpossibilities.com/donate.asp

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FDA Approves New Treatment for a Type of Late-Stage Skin Cancer

2011-03-25T17:19:00.000-04:00

/PRNewswire/ --The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."

Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body's immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body's immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously.

Yervoy's safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed.

The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone.

Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. When severe side effects occurred, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.

Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform health care professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects.

Yervoy is marketed by New York City-based Bristol-Myers Squibb.

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FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age

2011-03-24T20:37:00.000-04:00

The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.

In the United States shingles affects approximately 200,000 healthy people between the ages of 50 and 59, per year. It is a disease caused by the varicella-zoster virus, which is a virus in the herpes family and the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerves in the body. For reasons that are not fully understood, the virus can reappear in the form of shingles, more commonly in people with weakened immune systems and with aging.

"The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease" said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

Shingles is characterized by a rash of blisters, which generally develop in a band on one side of the body and can cause severe pain that may last for weeks, and in some people, for months or years after the episode.

Approval was based on a multicenter study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles. Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent.

The most common side effects observed in the study were redness, pain and swelling at the site of injection, and headache.

Zostavax was originally approved on May 26, 2006, for the prevention of shingles in individuals 60 years of age and older.

Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New Jersey.

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American Heart Association Meeting Report- Metabolic Abnormalities in Obese Teens May Relate to Poor Diets

2011-03-23T10:54:00.000-04:00

/PRNewswire/ -- Obese teens may feel healthy, but blood tests show they have inflammation, insulin resistance, and high homocysteine levels, researchers report at the American Heart Association's Nutrition, Physical Activity and Metabolism/Cardiovascular Disease Epidemiology and Prevention 2011 Scientific Sessions.

"The metabolic abnormalities suggest that the process of developing heart disease has already started in these children, making it critical for them to make definitive lifestyle and diet changes," said Ashutosh Lal, M.D., senior author of the study and a pediatric hematologist at the Children's Hospital and Research Center Oakland in California.

Researchers compared the diets and blood test results of 33 obese youths (ages 11 to 19) with 19 age-matched youths of normal weight. Obesity in youths is a body mass index (BMI) higher than the 95th percentile of children the same age. Normal weight youths had a BMI below the 85th percentile. Body mass index is a measure of weight related to height. Two thirds of the participants in both groups were girls. All of the participants were receiving regular health maintenance care at an inner city clinic in Oakland.

Blood tests revealed that the obese teens had:

* C-reactive protein levels almost ten times higher than controls, indicating more inflammation in the body.
* Insulin resistance, a precursor to type 2 diabetes, with greater amounts of insulin needed to keep blood sugar levels normal.
* Homocysteine levels 62 percent higher than controls. High levels of the amino acid homocysteine are related to greater heart disease risk.
* Total glutathione levels 27.9 percent lower than controls, with oxidized glutathione levels 125 percent higher. A higher ratio of oxidized to non-oxidized glutathione indicates oxidative stress, an imbalance in the production of cell-damaging free radicals and the body's ability to neutralize them. Oxidative stress leads to more inflammation and an increase in blood vessel damage and stiffening.

"Looking at the numbers you would think these children might feel sick, but they did not," Lal said. "They are apparently feeling well, but there is a lot going on beneath the surface."

Dietary quality was poor in all the children – low in fresh produce, fiber, and dairy products. On questionnaires, obese and normal-weight children reported consuming similar amounts of grains, proteins, fats and total calories. However, the obese children reported significantly fewer servings of dairy products and tended towards fewer fruit servings. The obese children's diets were lower in potassium, vitamin C, vitamin D, and vitamin A, found in fortified dairy products and as well as in deeply colored fruits and vegetables.

With such poor dietary quality in both the obese and control groups, clinicians should pay more attention to what their young patients are eating, researchers said.

"Obese teens were consuming too few of the natural sources of anti-oxidants, fruits and vegetables, and may have increased antioxidant needs based on the inflammation associated with their extra adiposity," Lal said. "For their heart health, obese teens need to eat better, not just eat less."

Though the study's participants attended an inner city health clinic, researchers said the metabolic differences between obese and normal-weight teens would be found in all socioeconomic groups.

The children in the study were racially diverse. The obese group was 39 percent African-American, 30 percent non-African-American Hispanic, 18 percent Caucasian and 6 percent Asian and 7 percent other. The control group was 21 percent African-American, 5 percent Hispanic, 42 percent Caucasian, 21 percent Asian and 11 percent other.

This study was funded by the Clinical and Translational Science Institute, University of California, San Francisco, and the Bruce and Giovanna Ames Foundation.

Co-authors are: Michele Mietus-Snyder, M.D.; Jung H. Suh, Ph.D.; Bruce N. Ames, Ph.D.; and Betty Flores, P.N.P. Author disclosures are on the abstract.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding.

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Inaugural White Coat Grady Gala: Honoring Healthcare Heroes

2011-03-15T10:06:00.002-04:00

Presented by Delta Air Lines
Saturday, March 19, 2011 | 6:30pm
Georgia Aquarium
255 Baker St. NW | Atlanta, GA | 30313

Join Grady Health Foundation as they kick-off their annual fundraising campaign with an evening at the Georgia Aquarium celebrating visionary philanthropist, Bernie Marcus, notable general surgeon and author, Dr. David Feliciano, inspiring mentor and Chief Nursing Officer, Dr. Rhonda Scott as well as next generation healer and Chief Surgical Resident, Dr. Carla Haack. Grady Health Foundation was formed to encourage corporations, foundations, and individual citizens to invest in the continued health and wellbeing of Atlanta through this vital public resource. This black-tie gala promises to be a unique tribute honoring a select group of healthcare heroes!

Please visit www.gradyhealthfoundation.org or contact 404-489-1550 for more information.

FDA approves Benlysta to treat lupus

2011-03-10T11:14:00.000-05:00

The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.

Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.

“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system.

Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.

Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.

The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.

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FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis

2011-03-06T11:21:00.000-05:00

The U.S. Food and Drug Administration today (March 4) announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and postmarket reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning.

In patients with PAH, Letairis slows the worsening of symptoms and improves the ability to exercise. Approved in 2007, Letairis is in a class of medications called endothelin receptor antagonists, which stop the action of endothelin, a substance that narrows blood vessels and prevents normal blood flow in those with PAH.

“We have concluded that monthly liver enzyme testing for patients taking Letairis, as previously noted in the boxed warning, is not necessary,” said Mary Ross Southworth, Pharm.D., deputy director for safety in the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. “Health care professionals should still continue to order liver enzyme tests when they consider it clinically indicated.”

Letairis was approved with a Risk Minimization Action Plan (RiskMAP) to manage liver damage and fetal malformation. The RiskMAP called for liver enzyme testing prior to treatment and monthly during treatment for all patients. It also required monthly pregnancy testing for women of childbearing potential because Letairis causes birth defects in animals, like other drugs in this class. The Letairis RiskMAP was converted to a Risk Evaluation and Mitigation Strategy in 2009.

The boxed warning on the risk of serious birth defects and the contraindication for use during pregnancy will remain in the labeling. Letairis will continue to be available only through a restricted distribution program called the Letairis Education and Access Program (LEAP). For women who can become pregnant, monthly pregnancy tests will still be required before Letairis is shipped.

The liver warnings were based on experience with other drugs in Letairis’ drug class, as well as a few observed instances of increased liver enzymes in people treated with Letairis. The FDA’s further evaluation has shown that rates of liver problems in Letairis-treated patients are consistent with rates within the general PAH population. In the controlled clinical trials, the rates of liver problems in Letairis-treated patients are similar to the rates in people receiving an inactive pill (placebo).

For a discussion of the FDA’s rationale and regulatory decisions regarding Letairis, refer to the Drug Safety Communication issued today.

People who take Letairis should not stop taking it without talking to their health care professional. Health care professionals should order and review tests for liver function as necessary based on the patient’s condition and history. Adverse events involving Letairis should be reported to the FDA MedWatch program1.

Letairis is made by Gilead Sciences Inc., Foster City, Calif.

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FDA expands use of banding system for weight loss

2011-03-04T12:59:00.000-05:00

The U.S. Food and Drug Administration has expanded the use of Allergan’s LAP-BAND Adjustable Gastric Banding System, a device implanted around the upper part of the stomach to limit the amount of food that can be eaten at one time.

The Feb. 16, 2011, approval expands the use of the LAP-BAND to include obese individuals with a BMI of 30 to 34 who also have an existing condition related to their obesity.

The FDA approved the LAP-BAND in 2001 for use in severely obese patients with a body mass index (BMI) of at least 40, those with a BMI of at least 35 and who also have an existing severe condition related to their obesity, such as heart disease or diabetes, or those who are at least 100 pounds overweight. BMI is a general measure of body fat based on an individual’s weight and height.

The LAP-BAND is intended to be used for weight loss in adults who have not lost weight using non-surgical weight loss methods. The newly-approved indication is limited to patients with a BMI of 30 to 34 and at the highest risk of obesity-related complications. This represents a narrower indication than originally sought by Allergan. The company had also proposed to expand the indication to include people with a BMI of 35 to 39 and no obesity related condition. Patients using the LAP-BAND must be willing to make major changes to their lifestyle and eating habits.

“Obesity is a major public health concern in the United States,” said William Maisel, M.D., M.P.H., deputy director for science at the FDA’s Center for Devices and Radiological Health. “A healthy lifestyle and weight loss are keys to improvements in health and a person’s overall quality of life.”

Use of the LAP-BAND in patients with BMIs between 30 and 40 was examined in a U.S. study. Results showed that 80 percent of patients lost at least 30 percent of their excess weight and kept it off for one year. Some patients in the study lost no weight, while others lost more than 80 percent of their extra weight.

In the same study, more than 70 percent of patients experienced an adverse event related to LAP-BAND, most often vomiting and difficulty swallowing. The events ranged from mild to severe but most were mild and resolved quickly.

Seven out of 149 patients needed other procedures after implantation: four to remove the LAP-BAND, two for port revisions, and one to reposition the LAP-BAND.

The LAP-BAND works by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested, to help people eat less. It is placed around the upper part of the stomach during a surgical procedure. The band creates a small stomach pouch that holds a small amount of food.

The LAP-BAND should not be used in certain people, for example, those who are poor candidates for surgery, have certain stomach or intestinal disorders or an infection, take aspirin frequently, or are addicted to alcohol and/or drugs. It should also not be used in those not able or willing to follow dietary and other recommendations.

The LAP-BAND is marketed by Allergan Inc., based in Goleta, Calif.

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FDA approves new drug to treat chronic obstructive pulmonary disease

2011-03-01T11:33:00.000-05:00

The U.S. Food and Drug Administration approved roflumilast, a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. An exacerbation can last up to several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety.

Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States.

Roflumilast, a new drug class for the treatment of COPD, is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4). It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD which involves primary emphysema.

“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis and a history of exacerbations in managing this debilitating disease.”

The safety and effectiveness of roflumilast was demonstrated in two Phase 3 clinical studies that included more than 1,500 patients ages 40 and older who received roflumilast. Those treated had a history of COPD associated with chronic bronchitis and had experienced an exacerbation of the disease during the 12 months prior to beginning treatment.

The FDA approved roflumilast with a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behavior, as well as unexplained weight loss.

Roflumilast should not be used to treat sudden breathing problems (acute bronchospam), and is not recommended for people younger than 18 years. The most common side effects reported by those receiving roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

Roflumilast is marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

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The More Times a Woman Gives Birth, the Higher Her Risk of Rare but Aggressive 'Triple-Negative' Breast Cancer

2011-02-25T18:28:00.000-05:00

/PRNewswire/ -- Full-term pregnancy has long been associated with a reduced risk of breast cancer, but a new study finds that the more times a woman gives birth, the higher her risk of "triple-negative" breast cancer, a relatively uncommon but particularly aggressive subtype of the disease. Conversely, women who never give birth have a 40 percent lower risk of such breast cancer, which has a poorer prognosis than other types of breast cancer and doesn't respond to hormone-blocking therapies such as tamoxifen.

These findings, from a study led by Amanda Phipps, Ph.D., a postdoctoral research associate in the Public Health Sciences Division of Fred Hutchinson Cancer Research Center, are published online ahead of the March 16 issue of the Journal of the National Cancer Institute.

"Unlike most breast cancers, triple-negative tumors don't depend on hormonal exposures to grow and spread, so our assumption going into the study was that reproductive factors would not be associated with a woman's risk of this cancer subtype," Phipps said. "We were surprised by these findings because researchers have known for quite some time that women who have children, especially those who have them at an early age and have multiple full-term pregnancies, have a lower risk of breast cancer overall."

While never giving birth appears to be protective against triple-negative breast cancer, the researchers found that women who remain childless have about a 40 percent higher risk of estrogen-receptor-positive breast cancer - the most common form of the disease, which can be treated with estrogen-blocking drugs - as compared to those who have one or more offspring. This higher risk of estrogen-receptor-positive breast cancer among women who have not had children is well established, and it is thought to be related to the fact that such women do not undergo pregnancy-related changes in the breast that confer a lifelong protective effect.

"The mechanisms by which full-term pregnancy contributes to an increased risk of triple-negative breast cancer and a decreased risk of other forms of the disease are not clear," Phipps said. "We do know that the hormones of pregnancy induce certain changes in the cellular structure of the breast. Overall, those changes seem to make the breast less susceptible to cancer. It is possible, however, that the increased risk of triple-negative breast cancer we found in women who had given birth may be due to some abnormal response of their breast tissue to the hormones of pregnancy. Another possibility is that pregnancy somehow makes the breast more susceptible to certain carcinogens even while reducing breast cancer risk overall," she said.

For the study, which was based on data from the Women's Health Initiative, Phipps and colleagues analyzed the detailed reproductive histories of some 150,000 postmenopausal women, more than 300 of whom went on to develop triple-negative breast cancer. "This particular study is significant because it is one of the largest studies ever conducted on the impact of reproductive history on triple-negative breast cancer," Phipps said.

Triple-negative breast cancer, which refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or Her2/neu, accounts for only 10 percent to 20 percent of all breast cancers, and only in the past decade have researchers become aware that this cancer subtype exists. "This research reinforces the notion that breast cancer is not just one disease," Phipps said.

"The mechanisms that lead to triple-negative breast cancer are likely different from those that lead to other forms of the disease. We still have a lot to learn about what causes this more aggressive form of breast cancer, but we hope that research like this will help us develop better tools to identify those women at greatest risk."

It is known that this cancer subtype is more predominant in African American women and it tends to be diagnosed at an earlier age. Researchers also know there is a strong link between genetic mutations in the so-called "breast cancer gene," BRCA1, and triple-negative breast cancer.

"More research is needed to better understand the causes of the most aggressive and lethal forms of breast cancer. While this study adds to our knowledge base, it should not change women's approaches to breast cancer screening," Phipps said.

The National Heart, Lung and Blood Institute of the National Institutes of Health funded the study, which also involved researchers from Albert Einstein College of Medicine, Georgetown University, Harbor-UCLA Medical Center, Stanford University, State University of New York at Stony Brook, the University of Buffalo, the University of Pittsburgh and Wake Forest University.

At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. www.fhcrc.org

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FDA Approves EDARBI (azilsartan medoxomil) for the Treatment of Hypertension

2011-02-25T18:26:00.000-05:00

/PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved EDARBI (azilsartan medoxomil) for the treatment of hypertension, or high blood pressure, in adults. EDARBI is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone that constricts blood vessels. When the angiotensin II receptor is blocked, blood vessels stay relaxed and open and blood pressure can be reduced. EDARBI is approved as a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications.

Takeda Global Research & Development Center, Inc. U.S. submitted a new drug application (NDA) for EDARBI in April 2010. The NDA was supported by seven controlled phase 3 clinical trials involving more than 5,900 patients with hypertension. Pivotal phase 3 studies showed EDARBI (80 mg/day) was statistically superior to placebo and the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day), in lowering both clinic and 24-hour mean blood pressure measurements.

"We are pleased to be able to build upon our global expertise in the cardiovascular therapeutic area with the approval of EDARBI in the U.S.," said Shinji Honda, president and CEO, Takeda Pharmaceuticals North America. "Through the discovery, development and commercialization of new medicines, Takeda is committed to bringing therapies like EDARBI to market. EDARBI is an important new treatment option for patients with hypertension and the health care professionals who treat them."

The safety and efficacy of EDARBI were studied as a once-daily oral therapy, as well as in combination with chlorthalidone and amlodipine. Results from the phase 3 clinical trials showed EDARBI successfully met the primary endpoint, change in 24-hour mean systolic blood pressure (SBP) as measured by Ambulatory Blood Pressure Monitoring, with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators. Specifically, results from one study showed EDARBI at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively. The blood pressure reductions of EDARBI (80 mg/day) were statistically superior to those of the active comparators valsartan 320 mg/day (-10.0 mm Hg) and olmesartan medoxomil 40 mg/day (-11.7 mm Hg). Similar results were observed in all three comparator studies. The most common adverse reaction in adults was diarrhea (2%).

About Hypertension

Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Hypertension impacts approximately 75 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. Hypertension is also costly to the nation's health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.

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Lasers ID Deadly Skin Cancer Better than Doctors

2011-02-23T15:15:00.000-05:00

High-resolution images from a laser-based tool developed at Duke University could help doctors better diagnose melanoma, the deadliest form of skin cancer.

The improved diagnoses could potentially save thousands of lives and millions of dollars in unnecessary healthcare costs each year.

The tool probes skin cells using two lasers to pump small amounts of energy, less than that of a laser pointer, into a suspicious mole. Scientists analyze the way the energy redistributes in the skin cells to pinpoint the microscopic locations of different skin pigments.

For the first time, scientists have the ability to identify substantial chemical differences between cancerous and healthy skin tissues, said Thomas Matthews, a Duke graduate student who helped develop the new two-laser microscopy technique.

The Duke team imaged 42 skin slices with the new tool. The images show that melanomas tend to have more eumelanin, a kind of skin pigment, than healthy tissue. Using the amount of eumelanin as a diagnostic criterion, the team used the tool to correctly identify all eleven melanoma samples in the study. The results appear in the Feb. 23 Science Translational Medicine.

The technique will be further tested using thousands of archived skin slices. Studying old samples will verify whether the new technique can identify changes in moles that eventually did become cancerous.

Even if the technique proves, on a large scale, to be 50 percent more accurate than a biopsy, it would prevent about 100,000 false melanoma diagnoses, said Warren S. Warren, director of Duke’s Center for Molecular and Biomolecular Imaging and a chemistry professor. Warren oversaw the development of the new melanoma diagnostic tool.

cancertissueWarren's group has succeeded in using the laser pump method to locate two different types of skin pigments in skin tissue, which may better identify developing melanoma, said James Grichnik, a dermatologist at the University of Miami who was not involved in the study.

The work is limited to fixed tissue on slides, but holds promise for diagnosing melanoma prior to biopsy, and the increased diagnostic accuracy, without unnecessary biopsies, is where the new tool could have cost-saving potential, he said.

Melanoma is the fifth-most common cancer for males and sixth-most common for females. In 2010, U.S. doctors diagnosed nearly 115,000 new cases of the disease, with nearly 8,700 resulting in death. The cancer is also one of the few where the death rate is increasing.

Doctors typically use a light and a magnifying glass or tissue biopsy, where a pathologist removes suspicious skin cells and looks at them under a microscope, to spot signs of disease. But using a lens and a light is a “17th century” technique that is only 85 percent accurate, at best, and tissue biopsy is not much more reliable, Warren said.

In 14 percent of biopsy diagnoses, pathologists would disagree on whether or not the sampled cells were cancerous, according to a 2010 study published in the Journal of American Academy of Dermatology. The statistic implies that two pathologists would have opposing diagnoses on 214,000 to 643,000 melanoma cases each year, Warren said.

When studying biopsied tissue, doctors typically follow the “when in doubt, cut it out” philosophy. If they are not sure about the health of the skin tissue, doctors remove additional skin around the diseased cells. The first and second tissue biopsies can cost thousands of dollars. If the melanoma is thought have spread, patients may then have lymph nodes in their arms removed or undergo chemotherapy, which dramatically adds to treatment costs.

But not all of the extra treatment is necessary because not all of the biopsied tissues are actually cancerous. Doctors need a more accurate way to diagnose melanoma, Warren said.

In 2009, he received a $1 million Challenge Grant from the National Institutes of Health, which was part of the American Recovery and Reinvestment Act of 2009, to develop the imaging tool.

The highly specialized lasers are currently commercially available and would only need to be added to the microscopes pathologists already use to diagnose melanomas. The cost for the added instrumentation is about $100,000, which may sound like a lot of money. But if each false positive melanoma diagnosis costs thousands of dollars, having such an instrument available for questionable cases could considerably reduce health care costs overall, Warren said.

He added that suspicious moles would still have to be removed from a patient and then imaged to detect cancer.

Matthews is working on imaging skin cancers grafted on to mice to see if the tool could become a device dermatologists could use to scan a mole without removing it. A device like that would be much more expensive and would not be ready for a few years, Warren said. However, pathologists could begin using the lasers to study biopsied tissue now.

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Fresenius Medical Care Receives FDA Clearance for 2008K@home™ Dialysis Machine

2011-02-23T14:51:00.000-05:00

(BUSINESS WIRE)--Fresenius Medical Care (NYSE: FMS), the world’s leading company devoted to patient-oriented renal therapy, announced today that the U.S. Food and Drug Administration (FDA) cleared its 2008K@home™ dialysis machine. Specifically designed to facilitate hemodialysis treatment in the home environment, the newly approved device offers many patients more options for achieving adequate dialysis in the comfort of their own home.

"The 2008K@home offers the broadest range of dialysis prescription delivery, regardless of patient size or metabolic needs,” said Chief Medical and Regulatory Affairs Officer Jose Diaz-Buxo, MD, FACP. “It offers versatility and the reliability of many years of experience with this platform." The 2008K@home combines the known safety, efficacy and reliability of the 2008® series hemodialysis machines with a simpler user interface and additional new features specifically designed to facilitate home hemodialysis. 2008K@home incorporates all standard performance and safety features expected in modern hemodialysis machines.

The 2008K@home will be available to patients in the late spring/early summer, 2011. For more information call 800-662-1237 ext. 2053.

2008K@home and 2008 are trademarks of Fresenius Medical Care.

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FDA approves product to prevent bleeding in people with rare genetic defect

2011-02-23T14:19:00.000-05:00

The U.S. Food and Drug Administration last week approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

Patients with congenital Factor XIII deficiency don’t make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding.

“This product helps fill an important need,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Corifact received orphan-drug designation by the FDA because it is intended for use in a rare disease or condition. It was approved for marketing under the FDA's accelerated approval regulations that require an on-going study to demonstrate that patients actually receive the clinical benefit predicted by the data obtained so far.

The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency. The most common side effects observed were hypersensitivity reactions (allergy, rash, pruritus, and erythema), chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in liver (hepatic) enzymes.

Corifact is made from the pooled plasma of healthy donors. People receiving Corifact may develop antibodies against Factor XIII that may make the product ineffective. It potentially can cause adverse events from abnormal clotting if doses higher than the labeled dose are given to patients.

Corifact is manufactured by CSL Behring of Marburg, Germany.

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FDA permits marketing of first test for most common cause of gastroenteritis outbreaks

2011-02-23T13:56:00.000-05:00

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food.

Norovirus is a leading cause of food-borne disease outbreaks in the United States.

Acute gastroenteritis is an inflammation of the stomach and intestine that can cause diarrhea, vomiting and stomach pain. Norovirus contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food or water, and by touching contaminated surfaces.

“This test provides an avenue for early identification of norovirus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Early intervention can halt the spread of an outbreak.”

The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients.

The manufacturer demonstrated the performance of the Ridascreen test by comparing results of it to the results of a norovirus reference standard for 609 fecal samples. When the fecal samples were tested with Ridascreen, overall results on average were less sensitive than those of standard reference tests, detecting norovirus across samples about 2/3 of the time it was present.

The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a '510(k)' premarket notification.

In March, the U.S. Centers for Disease Control and Prevention will be updating management and disease prevention guidelines for norovirus outbreaks. These guidelines will likely reflect substantial advances made in norovirus epidemiology, immunology, diagnostic methods and infection control.

Ridascreen is made by R-Biopharm AG, located in Darmstadt, Germany.

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FDA clears test to help patients with kidney transplants

2011-02-12T06:36:00.000-05:00

The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants.

Everolimus, marketed under the trade name Zortress, was approved by FDA in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk.

Transplant patients are routinely given drugs that suppress the immune system (immunosuppressants) such as a regimen containing everolimus, cyclosporine, basiliximab, and corticosteroids. These drugs help prevent organ rejection, which occurs when the body’s immune system attacks and destroys a transplanted organ.

Some immunosuppressants are associated with toxic side effects that can injure transplanted kidneys. Balancing the levels of immunosuppressants is critical since transplant patients must take these drugs for the rest of their lives.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

QMS Everolimus is one of a number of FDA-cleared or -approved tests physicians can use to monitor and manage immunosuppressant levels, including tests for cyclosporine, tacrolimus, and sirolimus. These tests, along with careful monitoring of clinical signs and symptoms of organ rejection, tissue biopsies, and other lab tests, may increase the chance of having a successful transplant and possibly extend the survival of a transplanted kidney.

In addition to other evaluations, Thermofisher, the manufacturer of QMS Everolimus, demonstrated the performance of the test by comparing results from the new test to the results from everolimus reference tests used in the clinical trial of everolimus. When the clinical trial blood samples were tested with QMS Everolimus, the results, on average, were similar to those of the clinical trial reference test.

More than 87,000 patients are awaiting a kidney transplant in the United States, according to the Health Resources and Services Administration’s Organ Procurement and Transplantation Network.

QMS Everolimus is manufactured by Waltham, Mass.-based Thermofisher. Zortress is marketed by East Hanover, N.J.-based Novartis.

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FDA approves first 3-D mammography imaging system

2011-02-12T06:34:00.000-05:00

The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.

The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.

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FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams

2011-02-08T16:05:00.000-05:00

/PRNewswire/ -- The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.

About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI's magnetic and radiofrequency fields can disrupt the pacemaker's setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.

The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker's use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.

"FDA's approval of the Revo pacemaker represents an important step forward toward greater device innovation," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI."

The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.

Revo is manufactured by Medtronic Inc. of Mounds View, Minn.

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FDA Clears First Diagnostic Radiology Application for Mobile Devices

2011-02-04T13:51:00.000-05:00

/PRNewswire/ -- A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.

The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.

"This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health.

Radiology images taken in the hospital or physician's office are compressed for secure network transfer then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.

In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician's ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.

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FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Women

2011-02-04T09:47:00.000-05:00

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.

The FDA approved Makena under the agency's accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (here, reducing the risk of delivery before 37 weeks of pregnancy) that is reasonably likely to predict a clinical benefit.

Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit. An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given Makena. Such outcomes include reducing the number of babies who do not survive or who suffer serious health problems shortly after birth.

"Preterm birth is a significant public health issue in the United States," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "This is the first drug approved by the FDA that is indicated to specifically reduce this risk."

A health care provider would give Makena once a week by injection into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy.

The FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind clinical trial. The study included 463 women 16 to 43 years of age who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth. Among women treated with Makena, 37 percent delivered early (before 37 weeks) as compared with 55 percent of women in the control group.

A separate study evaluated the development of children born to mothers enrolled in the controlled trial. In this study, children ages 2.5 years to 5 years reached similar developmental targets, regardless of the mother's treatment. The confirmatory study that is ongoing will be followed by a similar infant follow-up study, to be completed about 2018. That study is expected to include 580-750 infants, depending on the number of study sites and mothers willing to participate.

The most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives, nausea and diarrhea. Serious adverse reactions were rare; there was a single report each of blood clot in the lungs (pulmonary embolism) and an infection at the injection site.

The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The approved indications include threatened miscarriage. The original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Consumers and health care professionals are encouraged to report adverse events from medications to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Makena is manufactured by Baxter Pharmaceutical Solutions LLC, based in Bloomington, Ind.

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What Job Creators and Economists are Saying About the Democrats’ Health Care Law and Jobs

2011-01-26T14:52:00.002-05:00

As the Ways and Means Committee holds its first health care hearing of the 112th Congress – focusing on the impact of the Democrats’ health care law on employers and workers – here is a look at what many employers and economists are saying about the law:

Small Business Coalition for Affordable Health Care
“The self‐employed and small business community could not be more honest about the destructive effects the PPACA places on the nation’s job creators. This law is loaded with new mandates, new taxes and perverse incentives that will forever harm the workplace and the relationship between employers and their employees.”

National Federation of Independent Business (NFIB)
“Small business owners understand that PPACA is a fatally-flawed solution that they do not want and cannot afford. NFIB recently balloted its members, and 93% agreed that Congress should repeal the new law.”

Retail Industry Leaders Association (RILA)
“The health care reform bill signed into law last year fell short of our core needs as health care costs continue to escalate, the ability to custom tailor plans affordable for employees has diminished dramatically, and the government now has an unprecedented role in what was once a voluntary offering by our companies. For these reasons, we urge members of both parties to build upon the successes of the new law and rewrite.”

“We are opposed to any unforgiving mandate which levies a penalty should even one employee fall below an arbitrary threshold. We also cannot stand for a law that will subject employees to a “revolving door” effect of employer-sponsored and exchange-based plans.”

National Retail Federation (NRF)
“NRF has worked closely with the Obama Administration where possible to help smooth implementation of the law. We appreciate the Administration’s cooperative efforts to date. Nevertheless, we are convinced that the health reform law is in the whole misplaced and will hazard future job and economic growth. We strongly support this effort to repeal and replace the health reform law with more job-friendly health care reform that will concentrate first on reducing the cost of medical care.”

Letter from 200 Economists
“A Barrier to Job Growth: The Patient Protection and Affordable Care Act contains expensive mandates and penalties that create major barriers to stronger job growth. The mandates will compete for the scarce business resources used for hiring and firm expansion. The law also levies roughly $500 billion in new taxes that will enter the supply chain for medical services, raising the cost of medical services. At the same time that businesses juggle the potential for higher interest rates or higher taxes, these medical costs will translate to higher insurance premiums, further increasing the cost of operating a business in the United States.”

Cost to Treat Heart Disease in United States Will Triple by 2030

2011-01-24T12:31:00.000-05:00

/PRNewswire/ -- The cost to treat heart disease in the United States will triple by 2030, according to a policy statement published in Circulation: Journal of the American Heart Association.

"Despite the successes in reducing and treating heart disease over the last half century, even if we just maintain our current rates, we will have an enormous financial burden on top of the disease itself," said Paul Heidenreich, M.D., chair of the American Heart Association expert panel issuing the statement.

The panel estimated future medical costs based on the current rates of disease and used Census data to adjust for anticipated population shifts in age and race. The rigorous methods they devised didn't double count costs for patients with multiple heart conditions.

"These estimates don't assume that we will continue to make new discoveries to reduce heart disease," Heidenreich said. "If our ability to prevent and treat heart disease stays where we are right now, costs will triple in 20 years just through demographic changes in the population."

The panel said effective prevention strategies are needed to limit the growing burden of cardiovascular disease -- the leading cause of death in the United States that accounts for 17 percent of overall national health expenditures.

"Unhealthy behaviors and unhealthy environments have contributed to a tidal wave of risk factors among many Americans," said Nancy Brown, American Heart Association CEO. "Early intervention and evidence-based public policies are absolute musts to significantly reduce alarming rates of obesity, hypertension, tobacco use and cholesterol levels."

Currently, 1 in 3 Americans (36.9 percent) have some form of heart disease, including high blood pressure, coronary heart disease, heart failure, stroke and other conditions. By 2030, approximately 116 million people in the United States (40.5 percent) will have some form of cardiovascular disease, the panel said. The largest increases are anticipated in stroke (up 24.9 percent) and heart failure (up 25 percent).

Between 2010-30, the cost of medical care for heart disease (in 2008 dollar values) will rise from $273 billion to $818 billion, the authors predicted. "We were all surprised at the remarkable increase in costs that are expected in the next two decades," Heidenreich said. "We need to continue to invest resources in the prevention of disease, the treatment of risk factors and early treatment of existing disease to reduce that burden."

Heart disease will also cost the nation billions more in lost productivity, increasing from an estimated $172 billion in 2010 to $276 billion in 2030. Productivity losses include days missed from home or work tasks because of illness and potential lost earnings due to premature death.

Co-authors writing on behalf of the various councils are: Justin G. Trogdon, Ph.D.; Olga A. Khavjou, M.A.; Javed Butler, M.D.; Kathleen Dracup, R.N., D.N.Sc.; Michael D. Ezekowitz, M.B.Ch.B., D.Phil.; Eric Andrew Finkelstein, Ph.D.; Yuling Hong, M.D., Ph.D.; S. Claiborne Johnston, M.D., Ph.D.; Amit Khera, M.D.; Donald M. Lloyd-Jones, M.D.; Sue A. Nelson, M.P.A.; Graham Nichol, M.D.; Diane Orenstein, Ph.D.; Peter W.F. Wilson M.D. and Y. Joseph Woo, M.D.

Author disclosures are on the manuscript.

The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding .

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FDA Approves Viibryd to Treat Major Depressive Disorder

2011-01-22T08:08:00.000-05:00

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

"Major depressive disorder is disabling and prevents a person from functioning normally," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression."

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

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U.S. Rep. Tom Price and Grace-Marie Turner, Galen Institute President, To Speak at Georgia Public Policy Foundation Luncheon Event on Feb. 4

2011-01-19T10:08:00.000-05:00

You are invited to attend a Georgia Public Policy Foundation Policy Briefing Luncheon at noon on Friday, February 4, 2011, at the Georgian Club, featuring Georgia Congressman Tom Price and Grace-Marie Turner, president of the Galen Institute.

The event, “Health Care Prognosis and Prognostications,” launches a yearlong series of events in celebration of the Foundation’s milestone 20th anniversary in 2011. It focuses on the status of health care legislation and reform efforts in Washington and what they mean to Georgia.

U.S. Representative Tom Price, an outspoken advocate for patient-centered health care reform in Washington, was elected to Congress in November 2004 to represent Georgia’s Sixth District and serves on the House Ways and Means and Budget committees. Before that, he served four terms in the Georgia State Senate and became the first Republican Majority Leader in the history of Georgia in 2002.

Congressman Price, an orthopedic surgeon, was Medical Director of the Orthopedic Clinic at Grady Memorial Hospital in Atlanta before his election to Congress. His signature legislation in Congress, the Empowering Patients First Act, would bring about positive changes to provide access for all Americans to affordable, quality health care. He is chairman of the House Republican Policy Committee, considered the principal forum for the development of GOP legislative initiatives.

Grace-Marie Turner is president of the Galen Institute, a public policy research organization she founded in 1995 to promote an informed debate over free-market ideas for health reform. She has been instrumental in developing and promoting ideas for reform that transfer power over health care decisions to doctors and patients. She speaks and writes extensively about incentives to promote a more competitive, patient-centered marketplace in the health sector.

Grace-Marie testifies regularly before Congress and advises senior government officials, governors and state legislators on health policy. She served a three-year term as a member of the National Advisory Council of Healthcare Research and Quality and served as a member of the Medicaid Commission. She is founder and facilitator of the Health Policy Consensus Group, a forum where analysts from market-oriented think tanks around the country analyze and develop policy recommendations. She is the editor of “Empowering Health Care Consumers through Tax Reform” and produces a widely read weekly electronic newsletter, Health Policy Matters.

In the mid-1990s, Grace-Marie served as executive director of the National Commission on Economic Growth and Tax Reform. For 12 years, she was president of Arnett & Co., a health policy analysis and communications firm.

This event is $35 to attend. The deadline to register is Wednesday, Feb. 2, 2011. To register, click on this link: http://tinyurl.com/3x6jz4d. Difficulty registering? E-mail mmmbrannen@gppf.org. Media interested in attending this event please contact Benita Dodd at benitadodd@gppf.org or 404-256-4050.

Who: U.S. Rep. Tom Price (R-Ga.) and Grace-Marie Turner, President of the Galen Institute
What: “Health Care Prognosis and Prognostications,” a Georgia Public Policy Foundation Policy Briefing Luncheon
When: Noon, Friday, February 4, 2011
Where: The Georgian Club, 100 Galleria Parkway, Suite 1700, Atlanta, GA 30339

About the Georgia Public Policy Foundation: The Foundation is an independent, state-based think tank that proposes practical, market-oriented approaches to public policy to improve the lives of Georgians. The Foundation’s regular events include Leadership Breakfasts and Policy Briefing Luncheons. Weekly publications are the Friday Facts and Friday Idea commentaries. Visit www.georgiapolicy.org to read about innovative solutions to the state’s challenges or to watch streaming online video of Foundation events. Join the Foundation’s Facebook Page, discuss state issues on our community site, The Forum, or follow us on Twitter at http://www.twitter.com/gppf.
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FDA Approves Head Lice Treatment for Children and Adults

2011-01-19T09:49:00.000-05:00

The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.

Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.

“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Head lice is a common problem among school children in the United States.”

Natroba is a topical drug product and should be applied only to the child’s scalp or hair. The product should be used exactly as prescribed by a health care professional.

The safety and effectiveness of Natroba Topical Suspension 0.9 %, has been established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free fourteen days after the final treatment of Natroba was approximately 86 percent compared to 44 percent of the control group.

Common adverse events reported include redness or irritation of the eyes and skin.

Safety in pediatric patients below the age of 4 years has not been established. Although Natroba is not approved for use in children younger than 4 years, it is especially important not to use in infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.

Natroba is manufactured for ParaPRO LLC of Carmel, Ind.

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Surveys show significant proportions of hospitals and doctors already plan to adopt electronic health records and qualify for federal incentive payments

2011-01-13T16:52:00.000-05:00

Four-fifths of the nation's hospitals, and 41 percent of office-based physicians, currently intend to take advantage of federal incentive payments for adoption and meaningful use of certified electronic health records (EHR) technology, according to survey data released today by the Office of the National Coordinator for Health Information Technology (ONC). The survey information was released as the registration period opened for the Medicare and Medicaid EHR Incentive Programs.

David Blumenthal, M.D., M.P.P., the National Coordinator for Health Information Technology, said the survey numbers represent a reversal of the low interest in EHR adoption in previous years. He credited leadership from the medical community and the federal government for the improved prospects for adoption and use of health information technology (health IT).

"For years we have known that electronic health records would improve care for patients and bring about greater cost effectiveness in our health sector, yet adoption rates by health care providers remained low," Dr. Blumenthal said. "In 2009, Congress and the President authorized major new federal support for EHR adoption and use, and in combination with medical professional and hospital leadership, I believe we are seeing the tide turn toward widespread and accelerating adoption and use of health IT."

The data released today comes from surveys commissioned by ONC and carried out in the course of regular annual surveillance by the American Hospital Association (AHA) and the National Center for Health Statistics (NCHS), an agency of HHS' Centers for Disease Control and Prevention (CDC).

The AHA survey found that 81 percent of hospitals plan to achieve meaningful use of EHRs and take advantage of incentive payments. About two-thirds of hospitals (65 percent) responded that they will enroll during Stage 1 of the Incentive Programs, in 2011-2012.

The NCHS survey found that 41 percent of office-based physicians are currently planning to achieve meaningful use of certified EHR technology and take advantage of the incentive payments. Four-fifths of these, or about a third of all office-based physicians (32.4 percent), responded that they will enroll during Stage 1 of the programs. Only 14 percent of respondents said they were not planning to apply for meaningful use incentives.

Additional survey data from NCHS show that significantly increasing numbers of primary care physicians have already adopted a basic EHR, rising by 50 percent from 19.8 percent of primary care physicians in 2008 to 29.6 percent in 2010. Basic EHRs provide a beginning point for use of electronic health records in physician offices, but most physicians would need to further upgrade their EHR systems or their use of the systems in order to qualify for meaningful use incentive payments.

Incentive payments for the adoption and meaningful use of certified EHR technology were authorized in the Health Information Technology Economic and Clinical Health Act (HITECH) in 2009. Incentive payments will be made through the Medicare and Medicaid programs. High rates of adoption and meaningful use could result in as much as $27 billion in incentive payments over 10 years.

Non-hospital-based physicians and other eligible professionals can obtain incentive payments of as much as $44,000 under Medicare or $63,750 under Medicaid. Under both Medicare and Medicaid, eligible hospitals may receive millions of dollars for implementing and meaningfully using certified EHR technology.

Provider registration for the Medicare EHR Incentive Program and some Medicaid EHR Incentive Programs opened Jan. 3, 2011. Most states will allow provider registration to begin for their Medicaid EHR Incentive Programs during the spring and summer of 2010.

"We are pleased to see this evidence of an enthusiastic early response, and we believe participation will continue to grow, especially as the Nation's physicians become more familiar with this one-time opportunity to improve care while helping to offset the costs of adopting EHR systems," said Donald Berwick, M.D., Administrator of the Centers for Medicare & Medicaid Services (CMS).

To qualify for incentive payments, under the Medicare EHR Incentive Program, providers must achieve meaningful use of certified EHR technology, under regulations issued by CMS and ONC. Medicaid providers can receive their first year's incentive payment for adopting, implementing, and upgrading certified EHR technology but must demonstrate meaningful use in subsequent years in order to qualify for additional payments.

Dr. Blumenthal said the meaningful use process has contributed to the increased willingness of providers to adopt EHR systems, especially because it guides providers through staged objectives for the productive use of EHRs, and because providers can now be assured that Complete EHRs and EHR Modules certified under ONC criteria by ONC-authorized testing and certification bodies can be relied upon to support the meaningful use objectives.

He also pointed to the technical support programs created under the HITECH Act and now operating under ONC, which offer support to providers as they switch from paper records to EHRs. In particular, 62 Regional Extension Centers (RECs) across the nation will offer customized, on-the-ground assistance, especially for smaller-practice primary care providers and for small hospitals and clinics.

"We know that adoption of EHRs and conversion to EHR-based care is expensive and challenging, especially for smaller providers," Dr. Blumenthal said. "With HITECH, we are able to provide unprecedented funding and technical support programs to help providers make the transition and to help our nation achieve the improvements in health care quality, safety and cost effectiveness EHRs will bring about."

Dr. Blumenthal also praised medical professional organizations and hospital leaders, who have encouraged members to act soon in taking advantage of HITECH support programs and adopting EHR systems.

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FDA Limits Acetaminophen in Prescription Combination Products; Requires Liver Toxicity Warnings

2011-01-13T09:56:00.000-05:00

/PRNewswire/ -- The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen, also called APAP, is a drug that relieves pain and fever. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER). "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death."

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication. Patients and health care professionals are being notified of the new limitation on acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.

"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider," said Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."

Acetaminophen also is widely used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients. The actions FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.

Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency's strongest warning for prescription drugs, be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.

An FDA advisory committee discussed the issue at a meeting in June, 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.

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FDA approves opioid analgesic to help cancer patients manage pain

2011-01-10T09:41:00.000-05:00

The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.

“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use. Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product. FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs such as the program approved for Abstral. FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.

“This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” added Dr. Jenkins. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”

The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.

Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Abstral is manufactured by ProStraken Inc., based in Bedminister, N.J.

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A Nod Towards Regulating Tobacco Products Similar to a Medical Device: The Significance of the Menthol Review

2011-01-09T13:45:00.000-05:00

/PRNewswire/ -- A recent article in Inside Health Policy entitled New Tobacco Review Process states:

"A new tobacco approval process that mimics device 510(k) clearance procedures could also require that industry supply clinical trial data and other information as the agency implements a mandate from the 2009 law that brought tobacco regulation under FDA's purview."

"Companies will have until March 11 to submit information comparing their products to a predicate product grandfathered into the system before February 2007 to prove that they are as safe or safer than tobacco products already on the market."

The determination regarding "safe or safer" is a scientific decision. It is likely that the FDA tobacco advisory committee, TPSAC, will be involved in reviewing a number of these determinations.

The menthol review will establish the precedent for the role scientific data will play in the regulation of the tobacco industry and its attendant products, whether or not they are regulated under a section that mimics Section 510(k) clearances.

The menthol review has already established one important precedent. The TPSAC is writing its own reports in lieu of editing drafts prepared for them by the FDA. The menthol review is about to establish another precedent–how the Center for Tobacco Products addresses petitions filed under the Data Quality Act, in particular the petition filed by CRE at http://www.thecre.com/tpsac/?p=541

Recognizing that TPSAC will be the gatekeeper to ensure that the regulation of the tobacco industry is based upon sound science -- not polemics -- the Center for Regulatory Effectiveness will make a major statement to TPSAC on January 10 regarding a serious omission in its review of the impact a ban on the sale of menthol cigarettes will have on contraband cigarettes.

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HHS Announces Health Center Planning Grant Opportunity

2011-01-07T12:26:00.000-05:00

/PRNewswire/ -- HHS Secretary Kathleen Sebelius today announced up to $10 million in funding for a Health Center Planning Grant (HCPG) opportunity for organizations across the country that would like to become a Community Health Center. The HCPG opportunity is intended to support organizations in the future development of a health center and will support approximately 125 HCPGs in FY 2011.

The Health Resources and Services Administration (HRSA) administers the Health Center Program. Health centers improve the health of the Nation's underserved communities and vulnerable populations. They assure access to comprehensive, culturally competent, quality primary health care services at more than 7,900 service delivery sites around the country to patients regardless of their ability to pay; charges for services are set according to income.

"This funding opportunity in the Affordable Care Act will help nurture organizations that answer the noble call to assist those who are medically underserved, underinsured and uninsured," said Secretary Sebelius.

"The HCPG grants help organizations qualify to become CHCs, which increases HRSA's ability to serve more people," said HRSA Administrator Mary K. Wakefield , Ph.D., R.N. "From oral health, behavioral health, to maternal wellness and serving those in rural communities, community health centers increase access for those in need of high quality preventive and primary health care."

Eligible entities for the FY 2011 HCPG include public or nonprofit private entities, including tribal, faith-based and community-based organizations that currently do not receive the following section 330 funding awards:

* Planning Grants
* Community Health Centers
* Migrant Health Centers
* Health Care for the Homeless
* Public Housing Primary Care Programs
* Primary Care Associations

For more information about eligibility, guidance and application submission for the HCPG, visit www.grants.gov. For more information on HRSA's community health center program, visit http://bphc.hrsa.gov/. For more information about Affordable Care Act investments in community health centers, visit www.HealthCare.gov.

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HHS and EPA announce new scientific assessments and actions on fluoride

2011-01-07T11:06:00.000-05:00

The U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA) today are announcing important steps to ensure that standards and guidelines on fluoride in drinking water continue to provide the maximum protection to the American people to support good dental health, especially in children. HHS is proposing that the recommended level of fluoride in drinking water can be set at the lowest end of the current optimal range to prevent tooth decay, and EPA is initiating review of the maximum amount of fluoride allowed in drinking water.

These actions will maximize the health benefits of water fluoridation, an important tool in the prevention of tooth decay, while reducing the possibility of children receiving too much fluoride. The Centers for Disease Control and Prevention named the fluoridation of drinking water one of the ten great public health achievements of the 20th century.

“One of water fluoridation’s biggest advantages is that it benefits all residents of a community—at home, work, school, or play,” said HHS Assistant Secretary for Health Howard K. Koh, MD, MPH. “Today’s announcement is part of our ongoing support of appropriate fluoridation for community water systems, and its effectiveness in preventing tooth decay throughout one’s lifetime.”

“Today both HHS and EPA are making announcements on fluoride based on the most up to date scientific data,” said EPA Assistant Administrator for the Office of Water, Peter Silva. “EPA’s new analysis will help us make sure that people benefit from tooth decay prevention while at the same time avoiding the unwanted health effects from too much fluoride.”

HHS and EPA reached an understanding of the latest science on fluoride and its effect on tooth decay prevention and the development of dental fluorosis that may occur with excess fluoride consumption during the tooth forming years, age 8 and younger. Dental fluorosis in the United States appears mostly in the very mild or mild form – as barely visible lacy white markings or spots on the enamel. The severe form of dental fluorosis, with staining and pitting of the tooth surface, is rare in the United States.

There are several reasons for the changes seen over time, including that Americans have access to more sources of fluoride than they did when water fluoridation was first introduced in the United States in the 1940s. Water is now one of several sources of fluoride. Other common sources include dental products such as toothpaste and mouth rinses, prescription fluoride supplements, and fluoride applied by dental professionals. Water fluoridation and fluoride toothpaste are largely responsible for the significant decline in tooth decay in the U.S. over the past several decades.

HHS’ proposed recommendation of 0.7 milligrams of fluoride per liter of water replaces the current recommended range of 0.7 to 1.2 milligrams. This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects. These scientific assessments will also guide EPA in making a determination of whether to lower the maximum amount of fluoride allowed in drinking water, which is set to prevent adverse health effects.

The new EPA assessments of fluoride were undertaken in response to findings of the National Academies of Science (NAS). At EPA’s request, in 2006 NAS reviewed new data on fluoride and issued a report recommending that EPA update its health and exposure assessments to take into account bone and dental effects and to consider all sources of fluoride. In addition to EPA’s new assessments and the NAS report, HHS also considered current levels of tooth decay and dental fluorosis and fluid consumption across the United States.

The notice of the proposed recommendation will be published in the Federal Register soon and HHS will accept comments from the public and stakeholders on the proposed recommendation for 30 days at CWFcomments@cdc.gov. HHS is expecting to publish final guidance for community water fluoridation by spring 2011. You may view a prepublication version of the proposed recommendation at http://www.hhs.gov/news/press/2011pres/01/pre_pub_frn_fluoride.html. Comments regarding the EPA documents, Fluoride: Dose-Response Analysis For Non-cancer Effects and Fluoride: Exposure and Relative Source Contribution Analysis should be sent to EPA at FluorideScience@epa.gov. The documents can be found at http://water.epa.gov/action/advisories/drinking/fluoride_index.cfm

For more information about community water fluoridation, as well as information for health care providers and individuals on how to prevent tooth decay and reduce the chance of children developing dental fluorosis, visit http://www.cdc.gov/fluoridation. For information about the national drinking water regulations for fluoride, visit: http://water.epa.gov/drink/contaminants/basicinformation/fluoride.cfm

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Detecting Esophageal Cancer with Light

2011-01-06T11:58:00.000-05:00

A tiny light source and sensors at the end of an endoscope may provide a more accurate way to identify pre-cancerous cells in the lining of the esophagus.

Developed by biomedical engineers at Duke University and successfully tested on patients during a clinical trial at the University of North Carolina at Chapel Hill, the device holds the promise of being a less invasive method for testing patients suspected of having Barrett’s esophagus, a change in the lining of the esophagus due to acid reflux. Acid reflux occurs when stomach acid splashes, or refluxes, up into the esophagus.

Long periods of acid reflux can change the cells that line the esophagus, making them appear more like intestinal cells than esophageal cells. These cellular changes can also be a precursor to cancer. As in most cancers, early identification of these pre-cancerous cells often leads to better outcomes for patients. Barrett’s esophagus afflicts more than one percent of the U.S. population, with most patients above the age of 50.

Using an endoscope to reach the esophagus via the nose, physicians shine short bursts of this light at locations of suspected disease and sensors capture and analyze the light as it is reflected back. In particular, they are trying to spot characteristic changes within the layer of cells known as the epithelium, which line cavities and surfaces throughout the body.

“By interpreting the way the light scatters after we shine it at a location on the tissue surface, we can the spot the tell-tales signs of cells that are changing from their healthy, normal state to those that may become cancerous,” said Neil Terry, a Ph.D. student working in the laboratory of Adam Wax, associate professor of biomedical engineering at Duke’s Pratt School of Engineering, who developed the device.

The team published their findings online in the January issue of the journal Gastroenterology.

“Specifically, the nuclei of pre-cancerous cells are larger than typical cell nuclei, and the light scatters back from them in a characteristic manner,” Terry continued. “When we compared the findings from our system with an actual review by pathologists, we found they correlated in 86 percent of the samples.”

UNC gastroenterologist Nicholas Shaheen, M.D., conducted the preliminary clinical trial of the device on 46 patients with Barrett’s esophagus.

“Currently, we take many random tissue samples from areas we where we think abnormal cells may be located,” Shaheen said. “This new system may make our biopsies smarter and more targeted. Early detection is crucial, because the cure rate for esophageal cancer that is caught early is quite high, while the cure rate for advanced disease is dismal, with a 15 percent survival rate after five years.”

The technology that Wax and his team developed for cancer detection is known as angle-resolved low coherence interferometry (a/LCI). The technique is able to separate the unique patterns of the nucleus from the other parts of the cell and provide representations of its changes in shape in real time.

“This optical approach of sampling allows us to cover more tissue sites in less time and has the potential to significantly improve our ability to spot and monitor these pre-cancerous cells,” Wax said. “This type of approach could be used to improve and perhaps one day supplant the physical biopsies currently being used.”

Wax pointed out that since approximately 85 percent of all cancers begin within the layers of the epithelium in various parts of the body, he believes that the new system could also work in such cancers as those of the colon, trachea, cervix or bladder.

The research was supported by the National Institutes of Health, the National Science Foundation and Oncoscope, Inc., a company Wax founded in 2006, based on the Duke technology. Wax has a financial interest in the company, and Terry is a consultant.

Oncoscope plans a clinical trial of the system for approval, and Wax said there could be a commercially available device as early as 2012.

By Richard Merritt

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HUD and HHS announce joint effort to assist nearly 1,000 non-elderly persons with disabilities to move from institutions to independence

2011-01-06T11:55:00.000-05:00

U.S. Housing and Urban Development (HUD) Secretary Shaun Donovan and Health and Human Services (HHS) Secretary Kathleen Sebelius announced today a joint partnership between the two agencies to help nearly 1,000 non-elderly Americans with disabilities leave nursing homes or other healthcare facilities to live independently. This is the first time two federal agencies are offering a combination of rental assistance, health care and other supportive services targeted to this population.

HUD is providing $7.5 million in rental assistance vouchers that will help nearly 1,000 individuals with disabilities rent private apartments. Public housing authorities in 15 states will administer the rental subsidies and will work with state human service agencies to identify eligible individuals who could benefit from the program. For a local breakdown of the funding announced today, visit HUD's Web site.

Individuals receiving rental assistance through the program will also receive health and social supports that will enable them to live independently. These supports are provided through the HHS Centers for Medicare and Medicaid's "Money Follows the Person" (MFP) grant program, which allows individuals who qualify for Medicaid-funded nursing home or other institutional care to receive supports - such as in-home nursing and personal care services - while living in the community instead. In places where the MFP program is not available, services will be provided by a state-sponsored institutional transitional program comparable to MFP that includes dedicated supportive services.

As part of President Obama's Year of Community Living initiative, HUD and HHS launched a joint effort to provide housing support for non-elderly persons with disabilities who are currently receiving long-term care in institutional settings. The interagency collaboration is intended to allow persons with disabilities to live productive independent lives in their communities rather than in institutions.

"The Obama administration is committed to helping Americans with disabilities live independent lives. Housing is a critical piece of the equation when it comes to transitioning out of institutions," said Donovan. "Coordinating this effort with the Department of Health and Human Services is an important step in ensuring that more Americans with disabilities will have the housing and support they need to fully participate in community life."

"Through our collaboration with the Department of Housing and Urban Development, I know that we will be able to dramatically change peoples' lives," said Sebelius. "Individuals with disabilities can have a life in the community that serves their needs and supports them in leading productive, meaningful lives."

The funding announced today is being provided through HUD's Rental Assistance for Non-Elderly Persons with Disabilities Program. It is part of the $40 million HUD made available April 2010 to public housing authorities across the U.S. to fund approximately 5,300 rental assistance vouchers for non-elderly persons with disabilities to promote independent living for this community. Public housing authorities applied for funding under two categories.

Last October, HUD awarded $33 million to support a first round of 4,300 vouchers, making it possible for non-elderly individuals with disabilities and their families to access affordable housing in communities that meet their housing needs and so avoid potential institutionalization. Today's announcement is for the second round funding to provide 948 vouchers targeted for non-elderly individuals with disabilities currently living in institutional settings, such as nursing homes, but who could move into a community with assistance.

These vouchers will augment work already being done by HHS' Centers for Medicare & Medicaid Services (CMS) through its Money Follows the Person (MFP) rebalancing demonstration program. Now in its fourth year, the MFP program has made it possible for almost 12,000 individuals to live more independent lives by providing necessary supports and services in the community. Twenty-nine states and the District of Columbia are currently participating in the MFP program and CMS is expecting a new round of grant applications on January 7th.

State Medicaid agencies and local human service organizations will link eligible families to local public housing authorities that will administer voucher distribution. To improve the connections between the housing authorities and Medicaid agencies, HUD and HHS have launched the Housing Capacity Building Initiative for Community Living Project to assist seniors and individuals with chronic conditions who are at risk of institutionalization or who currently receive care in institutional settings, in finding appropriate housing in order to live more independent lives.

The Community Living Initiative is an outgrowth of the 1999 landmark Supreme Court ruling in Olmstead v. L.C. In that case, the Court ruled that the Americans with Disabilities Act (ADA) protects a person with a disability from being unnecessarily institutionalized. The Court said that such forced institutionalization can lead to isolation and segregation of individuals with disabilities and be a serious and pervasive form of discrimination.

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Piedmont Newnan Hospital Receives Generous Donation

2011-01-03T13:55:00.000-05:00

$5.1 million gift is largest in Piedmont Healthcare history.

The Piedmont Newnan Hospital replacement facility on Poplar Road will offer enhanced services in the areas of interventional radiology, surgery, emergency care and women’s and neonatal services thanks to a major boost from Newnan Hospital Inc. Newnan Hospital Inc. (NHI) has made a historic gift valued at over $5.1 million to Piedmont Newnan Hospital, the largest, private, one-time gift in Piedmont Healthcare’s 105-year history.

Newnan Hospital Inc. is the legal entity that was the previous owner of Piedmont Newnan Hospital and continues today with a mission to support healthcare-related needs and initiatives to improve the healthcare of the local community.

“We are building a new hospital today because of the vision and perseverance of the Newnan Hospital Inc. Board of Directors,” said Michael Bass, president and CEO of Piedmont Newnan Hospital. “This transformational gift demonstrates loud and clear Newnan Hospital Inc.’s longstanding commitment to improving healthcare for all citizens of Coweta County. We sincerely thank the board for this most generous gift.”

The gift includes $4 million of enhancements and additions, previously not programmed into the scope of the replacement hospital. A major portion of the funds will purchase medical equipment in interventional radiology services and will enable the build-out of two additional surgical suites, including one with enhanced capabilities for urological procedures. The additional rooms will improve scheduling and availability of surgery and other procedures for patients and doctors.

In addition, it will provide further enhancements to the emergency department, including multi-purpose, ceiling equipment booms in the trauma rooms to keep the floors clear of diagnostic equipment; a faster, 64-slice CT scanner; and critical care monitors compatible with future technology. Additionally, pediatric and infant resuscitation equipment and infant warmers will be purchased for exclusive use in the emergency department, rather than be shared with the labor and delivery unit. For women’s and neonatal services, the donation will allow the provision of dedicated NICU incubators with resuscitation capability in all rooms, including delivery rooms.

In making the announcement, Tom Moat, president of the Newnan Hospital Inc. Board of Directors, expressed the board’s feeling on how important it is for NHI to be involved in providing the best possible hospital for residents of the Coweta community.

“Piedmont is going to provide our community with a new, state-of-the-art hospital, and we believe it is important for Newnan Hospital Inc. to take the lead in helping augment vital services in the new facility,” said Moat. “We can help provide enhanced services that will benefit all of us for many years.”

“Having been in the hospital business for almost 90 years, our board recognizes that community support includes both using services available at our local hospital and supporting it financially,” added Moat. “We are grateful to Piedmont Healthcare for all they are doing by building a new hospital facility. We want to help through these donations and hope this will encourage others to support further development of the new hospital and advance healthcare in our community.”

The gift also includes the property on the court square in downtown Newnan, which serves as the Piedmont Newnan Hospital Wellness Center. Valued at $840,000, Piedmont Newnan Hospital will continue operating the downtown Newnan Wellness Center for the community.

The third element of the gift is an additional $260,000 set aside for the utilization of the original Newnan Hospital campus, located at 80 Jackson Street. This campus currently houses both the Piedmont Newnan Hospital Ambulatory Surgery Center and the Piedmont Heartburn Treatment Center. These services will be relocated to the new facility on Poplar Road, scheduled to open in the spring of 2012.

“This gift from Newnan Hospital Inc. represents the largest one-time gift in Piedmont’s history and sets the stage for fundraising efforts to support the new hospital,” said R. Timothy Stack, president and CEO of Piedmont Healthcare. “To the 500-plus annual donors who already support Piedmont Newnan Hospital, as well as our Auxilians and our community, this contribution makes a bold statement that through philanthropy, we have the ability to make a tremendous impact on the quality of local healthcare in the communities we serve.”

This gift is the largest in a series of recent gifts made by NHI to benefit healthcare in Coweta County. Earlier this fall, NHI announced a $2 million gift to University of West Georgia’s School of Nursing; a $1 million gift to West Georgia Technical College, benefiting the allied health sciences programs; and another $1 million contribution to the new Coweta Samaritan Clinic.
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FDA: Gardasil approved to prevent anal cancer

2010-12-24T13:10:00.000-05:00

The U.S. Food and Drug Administration today (December 22) approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all of the indications for use approved by the FDA, Gardasil's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

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UGA researchers develop rapid diagnostic test for common type of pneumonia

2010-12-20T09:30:00.000-05:00

University of Georgia researchers have developed a technique that can diagnose a common type of pneumonia within minutes, potentially replacing existing tests that can take several days for results.
The researchers, whose findings are detailed online in the journal PLoS ONE, detected Mycoplasma pneumoniae, which causes atypical or “walking pneumonia,” in true clinical samples with over 97 percent accuracy using a recently-developed nanotechnology-based platform.

“If you can make a positive identification from a 10-minute test, then appropriate antibiotics can be prescribed, limiting both the consequences in that patient and the likelihood that it will spread to others,” said lead-author Duncan Krause, a professor in the department of microbiology in the UGA Franklin College of Arts and Sciences.

Krause and his colleagues built upon an existing technology called surface-enhanced Raman spectroscopy, which works by detecting spectral signatures of a near-infrared laser as it scatters off a biological specimen. They were able to enhance the Raman signal by using silver nanorod arrays to detect the tiny bacteria in throat swab specimens.

Krause, who also directs the interdisciplinary UGA Faculty of Infectious Diseases, compared the nanorod array developed by collaborator Yiping Zhao, director of the UGA Nanoscale Science and Engineering Center, to a brush with densely packed bristles, where each of the tiny silver rods extends out at a specific angle. The sample, such as bacteria from a throat swab, penetrates among the bristles, where the spectral signature produced by the laser is amplified and then analyzed by a computer program.

Krause noted that infections due to M. pneumoniae are very common yet difficult to diagnose. The bacterium is a major cause of respiratory disease in humans and the leading cause of pneumonia in older children and young adults.

“Walking pneumonia feels like a bad chest cold that will not go away,” he explained. “It can persist for weeks and even months and can cause permanent damage to the lungs if not diagnosed promptly. A delay in diagnosis extends the likelihood for complications as well as continued transmission of the infection to others.”

Krause said the device can be reduced to a size that could fit in a briefcase, although their testing is currently done only in a laboratory setting. “Our hope is that when we begin to explore the capabilities of this technology, it can be applied in point-of-care testing,” he added. “Then the impact becomes truly significant.”

Krause hopes the combined efforts of the research specialists in nanotechnology and infectious disease will eventually be able to determine if the technique is effective in detecting other pathogens in clinical samples. “We need to do a thorough job with mycoplasmas first,” said Krause. “Then we can go to other clinical samples and ask the same questions with other infectious agents.”

Funding for the research was provided by the U.S. Army Research Laboratory, the National Science Foundation and the Georgia Research Alliance.

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FDA begins process to remove breast cancer indication from Avastin label

2010-12-17T08:55:00.000-05:00

The U.S. Food and Drug Administration announced today (December 16) that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

“After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”

Removing the breast cancer indication from the Avastin label will be a process. This is the first step. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

The agency has informed Genentech, Avastin’s manufacturer, of its proposal to withdraw marketing approval of the drug for breast cancer. Genentech has not agreed to remove the breast cancer indication voluntarily, so the agency has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination. The company has 15 days to request a hearing; if it does not do so, the hearing will be waived, and FDA will begin proceedings to remove the breast cancer indication.

Avastin, in combination with chemotherapy (paclitaxel), was approved in February 2008 under the FDA’s accelerated approval program, based on the results of a clinical trial known as “E2100,” which evaluated the drug in patients who had not received chemotherapy for their metastatic HER2-negative breast cancer. Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this. The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.

After the accelerated approval of Avastin for breast cancer, Genentech completed additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on “progression-free survival” without evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. The small increase in “progression-free survival” reflects a small, temporary effect in slowing tumor growth.

Avastin has also been associated with several other serious and potentially life-threatening side effects including the risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.

On the basis of all available data relating to the use of Avastin to treat metastatic breast cancer, the agency has determined that the risks of the drug outweigh the benefits for this use.

FDA is open to working with Genentech on any proposals to conduct additional studies of Avastin in patients with metastatic breast cancer designed to identify a population of patients in which the drug’s benefits exceed the risks.

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Stroke Drops to Fourth Leading Cause of Death in 2008

2010-12-09T18:31:00.000-05:00

/PRNewswire/ -- Stroke is now the fourth leading cause of death in the United States, down from the third place ranking it has held for decades, according to preliminary 2008 death statistics released today by CDC's National Center for Health Statistics. While deaths from stroke and several other chronic diseases are down, deaths due to chronic lower respiratory disease increased in 2008.

There were 133,750 deaths from stroke in 2008. Age-adjusted death rates from stroke declined 3.8 percent between 2007 and 2008. Meantime, there were 141,075 deaths from chronic lower respiratory disease, and the death rate increased by 7.8 percent.

Some of the increase in deaths may be due to a modification made by the World Health Organization in the way deaths from chronic lower respiratory diseases are classified and coded. The National Center for Health Statistics will conduct a thorough analysis on this change and its effect on the chronic lower respiratory disease category before the final 2008 deaths data are released.

"Deaths: Preliminary Data for 2008," also finds that life expectancy at birth dropped slightly to 77.8 years from 77.9 years in 2007. Life expectancy was down by one-tenth of a year (a little over a month) for both men and women. However, black males had a record high life expectancy in 2008 of 70.2 years – up from 70 years in 2007. The life expectancy gap between the white and black populations was 4.6 years in 2008, a decrease of two-tenths of a year from 2007.

The data are based on 99 percent of death certificates reported to NCHS through the National Vital Statistics System from all 50 states, the District of Columbia and U.S. territories.

Other findings:

* Heart disease and cancer, the two leading causes of death, still accounted for nearly half (48 percent) of all deaths in 2008.
* In addition to stroke, mortality rates declined significantly for five of the other 15 leading causes of death: accidents/unintentional injuries (3.5 percent), homicide (3.3 percent), diabetes (3.1 percent), heart disease (2.2 percent), and cancer (1.6 percent).
* In addition to chronic lower respiratory disease, death rates increased significantly in 2008 for Alzheimer's disease (7.5 percent), influenza and pneumonia (4.9 percent), high blood pressure (4.1 percent), suicide (2.7 percent), and kidney disease (2.1 percent).
* The preliminary infant mortality rate for 2008 was 6.59 infant deaths per 1,000 live births, a 2.4 percent decline from the 2007 rate of 6.77 and an all-time record low. Birth defects were the leading cause of infant death in 2008, followed by disorders related to preterm birth and low birth weight. Sudden infant death syndrome (SIDS) was the third leading cause of infant death in the United States.
* Overall, there were 2,473,018 deaths in the United States in 2008, according to the preliminary deaths report -- 49,306 more deaths than the 2007 total.
* The age-adjusted death rate for the U.S. population fell to 758.7 deaths per 100,000 in 2008 compared to the 2007 rate of 760.2.

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Oncologists Value Survival Over Quality of Life, Study Finds

2010-12-09T09:48:00.000-05:00

For oncologists, drugs that help cancer patients live longer are worth more than drugs that help patients live well, according to research from Duke University's Fuqua School of Business and several health-related centers.

On average, oncologists were willing to prescribe treatments that cost about $245,000 to prolong life for one year, but the cost threshold dropped to about $119,000 per year for treatments that improve quality of life without prolonging patients' lives.

"Oncologists are understandably focused on survival, but they need to pay equal attention to the quality of life people experience during and after treatment," said senior author Peter Ubel, M.D., the John O. Blackburn professor of business administration at Fuqua.

The researchers found a wide range in what cancer doctors considered reasonable treatment costs. The threshold varied from $10,000 to $5 million per quality adjusted life year (QALY), a standard for assessing the cost-effectiveness of medical interventions. The spending thresholds assessed in the study were also measured in QALYs.

The research can be found on Medical Decision Making's website: http://bit.ly/fBIYBP.

The results highlight a critical problem in the struggle to control health care costs, Ubel said. Increasingly, doctors are being asked to consider whether very expensive cancer drugs -- some of which offer only small gains in survival -- are worth prescribing. But according to Ubel, the data on cost-effectiveness comes without guidelines for determining appropriate financial value in cancer care.

"Currently, individual oncologists are left to decide whether the benefits of expensive new drugs justify their costs," said Ubel. "Cancer care spending is unlikely to drop when there is such a broad range in what oncologists consider reasonable."

"The fact that these highly trained, wonderful doctors are confused about the issue suggests we as a society should discuss the cost of cancer care more explicitly. With health care spending emptying patients' pocketbooks, and bankrupting state and federal governments, we need to decide how much we should spend for small improvements in the quantity or quality of patients' lives."

The study results are based on a survey sent to members of the American Society of Clinical Oncology. The 768 physicians who responded considered two hypothetical scenarios involving a patient with metastatic cancer and a year to live.

The first scenario asked the doctor how much benefit, in months of survival gained, a new drug would need to provide for them to prescribe it. The new drug cost $75,000 more than standard treatment. The second scenario asked the doctor to indicate the highest cost at which they would prescribe a medication to improve the quality of life without prolonging survival.

The respondents consistently chose to spend more on life-prolonging treatments than on quality-enhancing treatments.

Additional authors of the study include Michael A. Kozminski and Aleksandra Jankovic of the Center for Behavioral and Decision Sciences in Medicine, University of Michigan Medical School in Ann Arbor, Mich.; Peter J. Neuman of the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center in Boston; and Eric S. Nadler of the Charles Sammons Cancer Center, Baylor University Medical Center in Dallas.

The study was funded by grants from the California Healthcare Foundation and the Tufts Medical Center.

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Mayo Clinic Finds Seizure Generation in Brain is Isolated from Surrounding Brain Regions

2010-12-08T10:19:00.000-05:00

Mayo Clinic researchers found that the part of the brain generating seizures in individuals with epilepsy is functionally isolated from surrounding brain regions. The researchers hope this finding could be a clinical biomarker to help identify individuals with abnormal brain function. This study was presented at the American Epilepsy Society's annual meeting in San Antonio on Dec. 4.

Epilepsy is a disorder characterized by the occurrence of two or more seizures. It affects almost 3 million Americans.

"The synchronization of local and distributed neuronal assemblies underlies fundamental brain processes like perception, learning and cognition," says Gregory Worrell, M.D., Ph.D., a Mayo Clinic epileptologist and an author of this study. "In neurological disease, neuronal synchrony can be altered, and in epilepsy the synchrony plays an important role in the generation of seizures."

Mayo Clinic researchers investigated neuronal synchrony by studying intracranial EEG (electroencephalogram) recordings from patients with epilepsy and control subjects with facial pain. Researchers discovered that the control patients had greater average synchrony than patients with focal epilepsy (when seizures are produced in a small part of the brain, not the entire brain). When implanted electrode pairs bridged seizure-generating brain and other brain regions, the synchrony was significantly less than between other electrode pairs in the epileptic brain and the control brain. The team also found that with greater activity in the seizure-generating region, there was less synchrony with neighboring tissue outside that region.

"Our study shows us that the part of the brain generating seizures is isolated from the surrounding brain regions," says Dr. Worrell. "This finding could serve as a clinical biomarker of an abnormal brain, and it can also be useful in epilepsy surgery and brain stimulation treatments, as well as helping us understand how seizures are generated." Other scientists involved in this research include C. Warren, Ph.D.; S. Hu; S. Stead, M.D., Ph.D.; B. Brinkmann, and M. Bower, Ph.
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UGA researchers identify key enzyme that regulates the early growth of breast cancer cells

2010-11-28T09:20:00.000-05:00

New University of Georgia research, published this week in the early online edition of the journal Proceedings of the National Academy of Sciences, has found that blocking the action of an enzyme called GnT-V significantly delays the onset and spread of tumors in mice with cancer very similar to many cases of human breast cancer.

When the GnT-V enzyme activity in the cells was increased in mammary gland cells, they increased proliferation and began to take on many characteristics of cancer cells. Using a mouse model of human breast cancer, tumors appeared when the enzyme was deleted, but onset was delayed an average of 10 weeks in the mice.

“In human terms,” said Michael Pierce, director of the UGA Cancer Center and study co-author, “the corresponding delay would be many months and maybe years. You basically are slowing everything down and keeping the cancer from forming and progressing very early.” Slowing the pace of the cancer could eliminate its spread to other organs, keeping it localized where it could be treated successfully, Pierce explained.

The researchers, lead by Hua-Bei Guo, assistant research scientist in the department of biochemistry and molecular biology in the Franklin College of Arts and Sciences, stimulated breast cancer formation in mouse mammary glands by over-expressing a her-2 protein that is a growth receptor on the cell surface. The researchers note that over-expression of her-2 is associated with 25 to 30 percent of human breast cancers.

The GnT-V enzyme makes glycans, which are sugars on the cell surface that change in defined ways when the cell becomes cancerous. Glycans are released from the cell as glycoproteins, making them a promising early-detection marker in blood. The researchers studied a glycan made by GnT-V that appears when normal breast cells become cancerous. The GnT-V glycan product is found on her-2 and other receptors and acts to regulate the number of cancer stem cells in the tissue. The number of these cancer stem cells determines how rapidly the cancer will form and develop.

“Glycans often are ignored by scientists, because they’re very complicated and present unusual problems to identify and understand,” said Pierce. “This study is an example of how particular glycans that are present on various cell receptors can actually modulate the onset of tumor formation. That may give us new drug targets and new ways to kill the cancer cells specifically.”

The finding of Guo and the research team at UGA’s Complex Carbohydrate Research Center that the elimination of a glycan-synthesizing enzyme significantly reduced the population of breast cancer stem cells is unprecedented, they note.

“That population of cells appears to drive breast tumor formation in many cases,” said Pierce, who also is UGA’s Mudter Professor in Cancer Research, “and our research suggests that glycans may be potential targets to kill them selectively.”

Pierce likened the cancerous stem cells to the queen of an ant colony. “You can try to get rid of the anthill, but it will just come back if you don’t kill the queen,” Pierce said. “If we can target those cancer stem cells for elimination, that would be the most effective treatment.”

The research was supported by the National Institutes of Health. For more information on the UGA Cancer Center, see www.uga.edu/cancercenter/.

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Xanodyne agrees to withdraw propoxyphene from the U.S. market

2010-11-19T11:10:00.000-05:00

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (EKG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Xanodyne is based in Newport, Ky.

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New Low-Cost Method to Deliver Vaccine Shows Promise

2010-11-19T09:38:00.000-05:00

/PRNewswire/ -- Researchers have developed a promising new approach to vaccination for rotavirus, a common cause of severe diarrheal disease that is responsible for approximately 500,000 deaths among children in the developing world every year. In a study published in the November issue of Clinical and Vaccine Immunology, a vaccine delivered as nasal drops effectively induced an immune response in mice and protected them from rotavirus infection. The new vaccine delivery system has also been tested successfully and found to be heat stable with tetanus and is currently being tested with diphtheria and pertussis.

The team from the Cummings School of Veterinary Medicine at Tufts University and Tufts University School of Medicine collaborated with researchers from Boston and Tulane Universities to test the effectiveness of immunization with harmless bacteria that were engineered to display rotavirus protein.

"The new vaccine, in conjunction with an agent that enhances immunity, induced sufficient antibody formation against rotavirus to protect mice against infection when the mice were exposed to rotavirus three weeks after their third immunization," explained John E. Herrmann, Ph.D., research professor in the infectious diseases division of the department of biomedical sciences at the Cummings School of Veterinary Medicine at Tufts University and the senior author of the published study.

"We created the rotavirus vaccine using a harmless bacterium called Bacillus subtilis (B. subtilis), which we can modify to display on its surface or in its cytoplasm proteins from infectious bacteria and viruses. When people are exposed to these proteins, they develop antibodies against them and therefore become immune to the bacteria and viruses," said the study's first author Sangun Lee, Ph.D., DVM, research associate at the Cummings School. "The B. subtilis bacteria are so harmless that they are part of the normal diet in several Asian countries."

"The vaccine with the Bacillus bacteria is very inexpensive to produce in large quantities and, unlike most traditional vaccines, requires no special purification steps before use. As a result, the cost of vaccine production is unusually low," explained Saul Tzipori, BVSc (DVM), DSc, Ph.D., Agnes Varis University Chair in Science and Society, distinguished professor of microbiology and infectious diseases, and director of the infectious diseases division of the department of biomedical sciences at the Cummings School. These findings are consistent with the team's previous studies in which they demonstrated that B. subtilis bacteria displaying a fragment of tetanus toxin protein completely protect mice from tetanus. Tetanus vaccines have been stored for more than a year at 113(o)F without any loss of potency, a property that may be common to all B. subtilis vaccines.

Vaccines currently available have to be stored in refrigerators or freezers until the moment they are administered. This cold chain is difficult and costly to maintain. In many parts of the world, there is insufficient refrigeration or electricity to keep vaccines cold. The lack of refrigeration combined with the lack of trained personnel, especially in rural areas in developing countries, make it impossible for many children and adults to be vaccinated against standard infections, such as tetanus, rotavirus, diphtheria, pertussis (whooping cough) and other diseases.

"In addition to being heat-stable and low-cost, the B. subtilis vaccines are given in the form of nasal drops or spray. A needle-free approach to vaccination is particularly advantageous in developing countries where clean needles and syringes and trained personnel are not always available," said team leader Abraham L. (Linc) Sonenshein, Ph.D., professor and acting chair of molecular biology and microbiology at TUSM and member of the genetics and microbiology program faculties at the Sackler School of Graduate Biomedical Sciences at Tufts.

"This vaccine project is still in the developmental stage," he continued. "The next major step for these vaccines is to show that they are safe and work well in humans, and then to extend the rotavirus and tetanus vaccine technology to include diphtheria, pertussis and other infectious diseases. Those diseases cause tens of thousands of deaths, particularly in newborns and in South-East Asia. We are actively looking for partners in the U.S. and around the world to help us pursue our goal of reaching the point where many childhood and adult vaccines can be manufactured in a way that avoids the need for injection or refrigeration. Jerry Keusch of Boston University School of Public Health and I started this project 15 years ago, and it has taken a long time to reach the stage where we now have effective needle-free vaccines. The technology has now advanced enough that we can expect to be successful with many other vaccines in a short time frame."

Additional authors include Boris R. Belitsky, Ph.D., assistant research professor in the department of molecular biology and microbiology at TUSM; James P. Brinker, M.P.H, in the department of biomedical sciences at the Cummings School; Kathryn O. Kerstein, MS, senior research associate in the department of molecular biology and microbiology at TUSM; David W. Brown, Ph.D., DVM, clinical assistant professor in the infectious diseases division of the department of biomedical sciences at the Cummings School; Gerald T. Keusch, MD, professor in the department of international health at Boston University School of Public Health, professor of medicine at Boston University School of Medicine and U.S. chairman of the Indo-U.S. Vaccine Action Program at the National Institutes of Health; and John D. Clements, Ph.D., professor and chair of the department of microbiology and immunology at Tulane University Health Sciences Center.

This study was supported by a grant from the Grand Challenges in Global Health program of the Bill and Melinda Gates Foundation, and this grant was administered by the Foundation for the National Institutes of Health. Patent applications related to the discoveries reported in these studies have been filed by Tufts University.

Lee S, Belitsky BR, Brinker JP, Kerstein KO, Brown DW, Clements JD, Keusch GT, Tzipori S, Sonenshein AL, Herrmann JE. Clinical and Vaccine Immunology.. 2010 (November); 17 (11): 1647-1655. "Development of a Bacillus subtilis-based rotavirus vaccine." DOI: 10.1128/CVI/00135-10.

Lee S, Belitsky BR, Brown DW, Brinker JP, Kerstein KO, Herrmann JE, Keusch GT, Sonenshein AL, Tzipori S. Vaccine. 2010 (September 24); 28 (41), 6658-6665. "Efficacy, heat stability and safety of intranasally administered Bacillus subtilis spore or vegetative cell vaccines expressing tetanus toxin fragment C." DOI:10.1016/j.vaccine.2010.08.016.

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FDA Approves Xgeva to Help Prevent Cancer-Related Bone Injury

2010-11-19T09:35:00.000-05:00

/PRNewswire/ -- The U.S. Food and Drug Administration approved Xgeva (denosumab) on Thursday to help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation.

Xgeva is a monoclonal antibody that targets a protein involved in cancer-related bone destruction called human RANKL. Other FDA-approved drugs for similar conditions include Zometa (zoledronic acid) and Aredia (pamidronate disodium).

Xgeva is not approved for patients with multiple myeloma or other cancers of the blood.

"Bone metastases represent a major cause of pain and suffering in patients with cancer and can affect a patient's quality of life," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer."

Xgeva's safety and effectiveness were confirmed in three randomized, double-blind clinical studies in 5,723 patients comparing Xgeva with Zometa. One study involved patients with breast cancer, another in patients with prostate cancer, and a third included patients with a variety of other cancers.

The studies were designed to measure the time until occurrence of a fracture or spinal cord compression due to cancer or until radiation or surgery for control of bone pain was needed.

In patients with breast or prostate cancers, Xgeva was superior to Zometa in delaying SREs. In men with prostate cancer, the median time to an SRE was 21 months with Xgeva compared to 17 months with Zometa.

In patients with breast cancer, the median time to an SRE was 26 months with Zometa and has not yet been reached with Xgeva. In patients with other solid tumors, time to development of an SRE was similar for both Xgeva and Zometa. The most common solid tumors were non-small cell lung cancer, multiple myeloma, kidney (renal) cancer, and small cell lung cancer.

The most serious side effects experienced with Xgeva were low calcium levels in the blood (hypocalcemia), and osteonecrosis of the jaw, a severe disease resulting from reduced blood flow to areas of the jaw and exposed jaw bone, causing pain, swelling, numbness, or infection.

Denosumab was originally approved under another trade name, Prolia, in June 2010. Prolia is indicated to treat postmenopausal women with osteoporosis who are at high risk for bone fractures. Xgeva is administered using a higher dose and with more frequent dosing than Prolia. Denosumab has a different safety profile in patients with osteoporosis than in patients with cancer and bone metastases.

Xgeva is marketed by Thousand Oaks, Calif.-based Amgen.

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