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

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

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

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

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

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

/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

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

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

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

(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

/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

/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

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

/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

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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