FDA: Gardasil approved to prevent anal cancer

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

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

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

/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

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

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

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

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

/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

/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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CDC Unveils New Adult Vaccination Rates; nfid Surveys Illuminate Barriers to Vaccine Uptake

/PRNewswire/ -- New data from the Centers for Disease Control and Prevention (CDC) show that adults remain largely unvaccinated against preventable infectious illnesses. At a news conference convened today by the National Foundation for Infectious Diseases (NFID), experts in public health, infectious disease, oncology and other medical specialties discussed the data and the health consequences for adults who skip vaccines. They collectively called on all adults and health care providers to improve vaccination rates.

"For more than six decades, vaccines have protected us from infectious illnesses that have a wide range of consequences, from lost work days and inability to meet our daily obligations, to pain, discomfort, hospitalization, long-term disability and death," said Susan J. Rehm, M.D., NFID medical director. According to Dr. Rehm, by foregoing needed vaccines, adults not only leave themselves vulnerable to sickness, but they expose those around them to unnecessary risks, too.

This problem is evident right now, as pertussis (whooping cough) continues to claim the lives of infants in California, while adults, who are frequently responsible for transmitting the disease to infants, fail to get the one-time pertussis booster vaccine. The impact of other vaccine-preventable infections may not be as immediately apparent, but they are no less important. Other vaccines for adults protect against viruses that cause several types of cancer, reactivation of the chickenpox virus that causes shingles later in life, and infection with bacteria that are the leading cause of community-acquired pneumonia.

New survey results from NFID suggest that doctor/patient communication challenges may be at least part of the problem. While physicians perceive they are encouraging their adult patients to be vaccinated, patients say the topic of vaccination rarely comes up during their doctor visits.

Vaccination rates highest among seniors; lowest among minority groups

In unveiling the adult vaccination data from the 2009 National Health Interview Survey (NHIS), Melinda Wharton, M.D., M.P.H., deputy director of the National Center for Immunization and Respiratory Diseases at the CDC, noted that the highest immunization rates are among older Americans, who tend to be vaccinated against influenza and pneumococcal infections. She suggested that one reason for this might be that older persons tend to have more routine visits with health care providers, providing more opportunities to learn about and adopt good preventive care behaviors.

"A good ongoing relationship with your medical provider is positive for so many reasons," said Dr. Wharton, "not least of which is that you will have an ongoing opportunity learn about the best ways to stay healthy, including the best preventive care choices like vaccines."

While adult vaccination rates are showing slow improvement overall, one vaccination trend Dr. Wharton specifically noted is the 7.4 percent decrease in pneumococcal vaccination rate in high-risk adults 19 to 64 years of age. She pointed out that this is not because people are suddenly foregoing this vaccine. Rather, the decrease reflects the recent addition of new risk groups -- namely smokers and people with asthma -- increasing the pool of people who should get the vaccine. Dr. Wharton called on smokers and people with asthma to check with their physicians or other health care providers about this vaccine.

In addition to generally low adult vaccination rates, Dr. Wharton touched on the problem of racial and ethnic vaccination disparities. While strides have been made to close racial and ethnic gaps, some significant vaccination gaps continue to exist among Whites, Blacks and Hispanics.

Vaccine (age and/or risk status)	Non- Hispanic White (%)	Non- Hispanic Black (%)	Hispanic or Latino (%)
Tetanus, diphtheria, pertussis (19-64 years)	51	54	49
Pneumococcal (65 years and older)	65	45	40
Pneumococcal (19-64 years, high risk)	18	18	12
Hepatitis B (19-49 years, high risk)	43	44	37
HPV (19-26 years)	20	13	13
Shingles (60 years and older)	11	4	5
Influenza (65 years and older)	69	51	51
Influenza (50-64 years)	42	37	31

The NHIS survey also reported vaccination rates in health care professionals for influenza (up 7 percent, to 53 percent), hepatitis B (up 2.5 percent, to 65 percent) and Tdap (up 1.6 percent, to 58 percent). "It's gratifying to see health care worker vaccination rates continue to increase," said CDC's Melinda Wharton. "By modeling good preventive care behaviors our health care professionals are truly leading the way as good partners in their relationship with patients." The NHIS vaccination data include anyone employed in a health care occupation or setting. In contrast, physician-only vaccination rates are much higher (>90 percent for influenza) as reported in two separate NFID surveys fielded before and during the current influenza season.

Doctor/patient communication breakdown a factor in low vaccination rates

A dramatic physician-patient communication disconnect was revealed by new data from two NFID surveys. Nearly 90 percent of primary care physicians say they discuss vaccines with their patients, yet in a separate survey of consumers, almost half cannot recall ever discussing vaccines with their physicians. As further evidence of the communication gap between physicians and their patients, 99 percent of physicians say that they or their staff initiates vaccine discussions, but just 44 percent of patients say that is true.

"Busy primary care physicians think they're doing a good job recommending vaccines, but the survey indicates that patients aren't getting the message," suggested Dr. Rehm. "Consumers overwhelmingly said they look to physicians for vaccine recommendations and are likely to act on those recommendations, so it's clear that we physicians need to be more effective in communicating with our patients."

Among the positive findings, consumer familiarity with vaccine-preventable illnesses is rising, although still limited. Familiarity with specific vaccine-preventable diseases rose 4 to 12 percent compared with results from a 2009 survey, with the largest increase for pertussis vaccine. The only vaccine-preventable disease not to register an increase in familiarity is pneumococcal vaccine. Consumers also report that they rarely refuse vaccines if their physicians recommend them.

A realized consequence: disease resurgence

The ongoing pertussis epidemic in California demonstrates the danger still posed by diseases once thought to be gone in the U.S. There are reports of more than 6,400 cases so far in California this year, the most since 1958. While pertussis can affect people of any age and in fact, national rates have been rising in adults, it is the infants who adults pass this on to who bear the burden. Ten infants, all younger than three months, have died from whooping cough in California this year.

Patrick Joseph, M.D., a California infectious disease physician who is NFID's vice president, implored adults to get the one-time booster vaccine, "While the epidemic is in adults, the tragedy is in kids. The situation is grave when babies too young to be immunized are dying."

Dr. Joseph said this crisis means California doesn't have the luxury of bringing people along slowly. The time to increase vaccination rates for pertussis is now. The California Department of Public Health recommends pertussis boosters for all adults, including those over 65, a move supported by the CDC's Advisory Committee on Immunization Practices (ACIP). At its October meeting, ACIP voted to extend pertussis booster vaccination recommendations to include adults 65 and older nationwide.

While California has been hardest hit so far, many other areas have seen increased cases this year, including Ohio, South Carolina, Michigan, Texas, Idaho, upstate New York and the Philadelphia suburbs. Since pertussis knows no boundaries, Dr. Joseph voiced his hope that adults outside his home state would also take notice and seek a Tdap vaccine now to protect themselves and infants around them.

Importance of pneumococcal and influenza vaccines also highlighted

AARP board member Catherine Georges, R.N., Ed.D., reminded adults that the time to get an influenza vaccine is now. "We know it's important for Americans of all ages to go out now and get the flu vaccine, but it's even more critical for people 50-plus," said Dr. Georges, a registered nurse and professor and chair of the department of nursing at Lehman College and the Graduate Center at the City University of New York. "Older Americans are often caring for their children and for older loved ones. Getting vaccinated not only protects you, but also helps protect your family and friends." Dr. Georges echoed the universal recommendation from CDC for influenza vaccination of all Americans six months and older.

Since pneumococcal infection is an all too frequent complication of influenza, Dr. Georges reminded Americans that, "pneumococcal and influenza vaccines can be given at the same medical visit." Pneumococcal vaccine is recommended for everyone 65 and older and for younger adults with certain risk factors or conditions like asthma, smoking, heart disease and diabetes. For most people, pneumococcal is a one-time vaccination.

Alarmingly few Americans immunized against debilitating disease of shingles

The lowest vaccination rate for a routinely recommended vaccine is for the shingles vaccine, which is recommended for everyone starting at age 60. Only ten percent of eligible persons have received the shingles vaccine. Not only does the likelihood of getting shingles increase with age, so does the severity of shingles pain, which can last long after the shingles rash has disappeared (this pain is known as post-herpetic neuralgia, or PHN). This pain diminishes quality of life and functional capacity as much as congestive heart failure, a heart attack, type II diabetes or major depression.

Adults in the NFID survey say they are familiar with shingles, but further questioning reveals knowledge gaps; for instance, 42 percent do not know that anyone who has had chickenpox is at risk for shingles. Still, adults are aware of the pain of the disease; 55 percent say they "know someone who has had it and it was terrible." Unfortunately, only half of adults even know there is a shingles vaccine available and just 16 percent know it is currently recommended for everyone 60 and older.

"Shingles can be a terribly painful and debilitating disease, particularly in the elderly," said Jeffrey Cohen, M.D., chief of the Laboratory of Infectious Disease at the National Institute of Allergy and Infectious Diseases. "Shingles pain can be very difficult to treat. Current therapies are only somewhat effective and often associated with frequent and problematic side effects, especially in older people, which is why it is vitally important that we educate Americans about the vaccine."

Vaccines prevent cancer

"Human papillomavirus (HPV) not only causes cervical cancer, but also a growing portion of head and neck cancers," according to Maura Gillison, M.D., Ph.D, Jeg Coughlin Chair of Cancer Research at the Ohio State University College of Medicine. "Twenty years ago about 40 percent of these cancers were due to HPV; today that number is over 60 percent in the U.S. Even more alarming is that these cancers are happening in younger people without traditional risk factors—smoking and alcohol consumption."

The hepatitis B vaccine also protects against certain cancers. The hepatitis B virus causes 30 percent of all liver cancers in the U.S. and doubles the risk of non-Hodgkin's lymphoma. Both HPV and hepatitis B viruses are common. An estimated 70 percent of Americans will be infected with HPV in their lifetime and up to 1.4 million Americans have chronic hepatitis B infection.

CDC recommends HPV vaccine for all women 19 to 26 years of age if not previously vaccinated and recommends the hepatitis B vaccine for all sexually active adults who are not in a long-term, mutually monogamous relationship and others in more defined risk groups.

"I urge everyone to get the HPV and hepatitis B vaccines as recommended," said Dr. Gillison. "These vaccines are truly life-saving. As a cancer-specialist, I can tell you that prevention is a far better option than treatment. These are not cancers you want to have or want your kids to have."

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Doctors Ask Congress for Freedom, Not Bigger Reimbursements

/PRNewswire/ -- Once again, the American Medical Association is begging Congress to postpone a fee cut for doctors under Medicare's "sustained growth rate" (SGR) method. Unless Congress acts, doctors' Medicare payments will be slashed 23% on Dec 1, then another 6% on Jan 1. The formula automatically kicks in when Medicare spending exceeds a certain amount.

On what the AMA calls White Coat Wednesday, Nov 17, doctors are urged to call Congress. But the Association of American Physicians and Surgeons (AAPS) advises a different message.

"The AMA and Congress have been playing this game of 'chicken' for more than 8 years," says Dr. Jane Orient, executive director of AAPS. [See: http://www.aapsonline.org/newsoftheday/001097] The AMA threatens doctors will quit seeing Medicare patients unless Congress stops the cuts.

"Meanwhile, the AMA and the government collude on a dictatorial system of price controls."

The values for thousands of medical procedures are set by a secretive 29-member panel called the RUC, the Relative Value Scale Update Committee, convened by the AMA. [See Wall Street Journal, Oct 26, 2010. http://online.wsj.com/article/SB10001424052748704657304575540440173772102.html?KEYWORDS=Relative+Value+Scale+Update] Once the RUC determines the formula for divvying up $60 billion for physician fees, the government accepts most of the recommendations and applies a "conversion factor" to give each fee a dollar amount.

Doctors who charge a different amount are heavily fined or sent to prison. Because of the price controls or ban on "balance billing," if the Medicare-allowed fee doesn't cover the cost, doctors simply can't provide the service. Patients who are willing and able to pay are not permitted to make up the difference. It amounts to a form of covert rationing.

"In a free-market system, patients and doctors decide on the fee," states Dr. Orient. "That is not necessarily the same as the insurance reimbursement."

Doctors who opt out of Medicare set their own fees, but patients cannot collect Medicare reimbursement for their services.

Instead of asking for more taxpayer money, AAPS asks Congress to restore the freedom of patients and physicians to make their own decisions, including the amount of the fee. Without all the expensive Medicare hassles, fees are often lower.

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Study: Starting with Chiropractic Saves 40% on Low Back Pain Care

(BUSINESS WIRE)--A new study finds that low back pain care initiated with a doctor of chiropractic (DC) saves 40% on health care costs when compared with care initiated through a medical doctor (MD), the American Chiropractic Association (ACA) announced today. The study, featuring data from 85,000 Blue Cross Blue Shield beneficiaries, concludes that insurance companies that restrict access to chiropractors for low back pain treatment may inadvertently pay more for care than they would if they removed such restrictions.

Low back pain is a significant public health problem. Up to 85 percent of Americans have back pain at some point in their lives. In addition to its negative effects on employee productivity, back pain treatment accounts for about $50 billion annually in health care costs—making it one of the top 10 most costly conditions treated in the United States.

The study, “Cost of Care for Common Back Pain Conditions Initiated With Chiropractic Doctor vs. Medical Doctor/Doctor of Osteopathy as First Physician: Experience of One Tennessee-Based General Health Insurer,” which is available online and will also be published in the December 2010 issue of the Journal of Manipulative and Physiological Therapeutics, looked at Blue Cross Blue Shield of Tennessee’s intermediate and large group fully insured population over a two-year span. The insured study population had open access to MDs and DCs through self-referral, and there were no limits applied to the number of MD/DC visits allowed and no differences in co-pays.

Results show that paid costs for episodes of care initiated by a DC were almost 40 percent less than care initiated through an MD. After risk-adjusting each patient’s costs, researchers still found significant savings in the chiropractic group. They estimated that allowing DC-initiated episodes of care would have led to an annual cost savings of $2.3 million for Blue Cross Blue Shield of Tennessee.

“As doctors of chiropractic, we know firsthand that our care often helps patients avoid or reduce more costly interventions such as drugs and surgery. This study supports what we see in our practices every day,” said ACA President Rick McMichael, DC. “It also demonstrates the value of chiropractic care at a critical time, when our nation is attempting to reform its health care system and contain runaway costs.”

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NIH Awards $10 Million to Develop Microneedle Vaccine Patch

The National Institutes of Health (NIH) has awarded $10 million to the Georgia Institute of Technology, Emory University and PATH, a Seattle-based nonprofit organization, to advance a technology for the painless, self-administration of flu vaccine using patches containing tiny microneedles that dissolve into the skin.

The five-year grant will be used to address key technical issues and advance the microneedle patch through a Phase I clinical trial. The grant will also be used to compare the effectiveness of traditional intramuscular injection of flu vaccine against administration of vaccine into the skin using microneedle patches. In animals, vaccination with dissolving microneedles has been shown to provide immunization better than vaccination with hypodermic needles.

"We believe that this technology will increase the number of people being vaccinated, especially among the most susceptible populations of children and the elderly," said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering, and the project's principal investigator. "If we can make it easier for people to be vaccinated and improve the effectiveness of the vaccine, we could significantly reduce the number of deaths caused every year by influenza."

Vaccine-delivery patches contain hundreds of micron-scale needles so small that they penetrate only the outer layers of skin. Their small size would allow vaccines to be administered without pain -- and could allow people to apply the patches themselves without visiting medical facilities.

While the ability to immunize large numbers of people without using trained medical personnel is a key advantage for the microneedle patch, the researchers have learned that administering the vaccine through the skin creates a different kind of immune response -- one that may protect vaccine recipients better.

"We have seen evidence that the vaccine works even better when administered to the skin because of the plethora of antigen presenting cells which reside there," said Ioanna Skountzou, co-principal investigator for the project and an assistant professor in Emory University's Department of Microbiology and Immunology. "This study will allow us to determine how we can optimize the vaccine to take advantage of those cells that are important in generating the body's immune response."

Among the issues to be addressed in the five-year study are:

• Developing an administration system that will be simple to use, intuitive and reliable. "Our goal is to make these patches suitable for self-administration, so that anybody could take a patch out of an envelope, put it on, and have it work with high reliability," Prausnitz said.

• Studying the long-term stability of vaccine used in the patches, and optimizing technology for incorporating it into the dissolving microneedles. "We need to put the vaccine into a dry form in this patch," said Prausnitz. "That will require different processing than is normally done with vaccines. We expect that this dry vaccine will provide enough stability that the patches can be stored without refrigeration."

• Evaluating the economic, regulatory, social and medical implications of a self-administered vaccine. PATH, an international nonprofit organization, will assist with this work, and will help strategically address any issues. "We will be assessing the barriers that may exist to introduction of a self-administered flu vaccine so we can anticipate those issues and develop possible solutions," said Darin Zehrung, leader of the vaccine delivery technologies group at PATH.

The funding will come from the Quantum program of the National Institute of Biomedical Imaging and Bioengineering (NBIB), which is part of the NIH. The initiative is designed to bring new medical technologies into clinical use.

While the funding focuses specifically on influenza vaccination, the lessons learned may advance other microneedle applications -- including vaccination efforts in developing countries where skilled medical personnel are limited and concerns about re-use of hypodermic needles are significant.

Additional design and development of the microneedle patch will largely be done at Georgia Tech, with vaccine development, immunological studies and the Phase I trial carried out at Emory University. The trial, to be conducted by the Hope Clinic of the Emory Vaccine Center, is expected to take place during the final year of the grant, setting the stage for Phase II and Phase III clinical trials that would be required to obtain FDA approval.

Ultimately, the goal will be to produce an influenza vaccine delivery patch that could be made widely available. Prausnitz expects that will be done by an established company with the ability to manufacture and market the devices.

Microneedle drug and vaccine delivery systems have been under development at Georgia Tech and elsewhere since the 1990s. The technology got a significant boost in July of 2010 with publication of a study in Nature Medicine that showed mice vaccinated with dissolving microneedles were protected against influenza at least as well as mice immunized through traditional hypodermic needle injections.

The patches used in that study contained needles just 650 microns long, assembled into arrays of 100 needles. Pressed into the skin, the needles quickly dissolved into bodily fluids thanks to their hydrophilic polymer material, carrying the vaccine with them and leaving only a water-soluble backing. In contrast, use of hypodermic needles leaves the problem of "sharps" disposal.

Prausnitz hopes that the $10 million in NIH funding will help accelerate development of the microneedle patches to make them available for general use within five to ten years.

"This research will focus on optimizing the microneedle-based delivery of vaccines into the skin and understanding how this method affects immune responses both at the mucosal surfaces of the body and through the systemic response inside the body," added Skountzou. "Combined with the convenience of self-administration, painless application and absence of sharps waste, this novel immunization route could make the microneedle patch a powerful new weapon against infectious diseases."

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FDA Approves New Treatment Option for Late-Stage Breast Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven's safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient's death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Halaven shows a clear survival benefit and is an important new option for women."

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late- stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

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New National Electronic Health Record Safety System Launched

/PRNewswire/ -- A new electronic health record (EHR) safety reporting system was announced today by the iHealth Alliance, a not-for-profit organization composed of medical society and professional liability carrier executives in collaboration with federal agencies and PDR Network. EHRevent.org establishes a national system where physicians and other health care providers can report issues related to the implementation and use of EHRs.

Using a standardized online format, EHRevent will collect reports from physicians and other health care providers who use EHRs and create reports that medical societies, professional liability carriers and government agencies, such as the U.S. Food and Drug Administration (FDA), will use to help educate providers on the potential challenges that EHR systems may bring. The system will be available directly via the Internet at www.EHRevent.org and also integrated into the web sites of participating liability carriers, medical societies, PDR Network and other partners, including EHR system vendors.

EHRevent was modeled after other national reporting systems, including the system used in the aviation industry, and its reports include issues related to software problems, inadequate user training, security breaches and near-misses. Reports will be confidential but used to better understand challenges associated with the adoption and implementation of EHRs and to improve patient safety.

"Electronic health records are being adopted at record rates and present an opportunity to advance patient care," said Nancy Dickey, M.D., iHealth Alliance chair and former president of the American Medical Association. "As with any new system, there is a learning curve for the software providers and for the doctors who use these systems. EHRevent will help us all get smarter about EHRs and assure that patient care advances are also patient-safe advances."

Professional liability carriers who insure doctors against malpractice claims are among the strongest supporters of EHRevent.

"EHRs can impact both the care that is delivered and the record of that care," explained David Troxel, M.D., medical director for The Doctors Company, which is the country's largest professional liability carrier. "EHRs can play a major role in advancing the practice of good medicine, but there are often unanticipated consequences when new technologies are deployed and it is important to collect and disseminate EHR user experience as these powerful systems are adopted."

Alan Lembitz, M.D., vice president of Patient Safety and Risk Management for COPIC Insurance Company, added, "Our experience indicates that EHRs have the capacity either to induce or to reduce medical errors in very unique ways, and we have seen data that indicates that EHR adoption may reduce physician liability. It will be increasingly important to understand best practices to improve patient safety for EHRs and for their users, and EHRevent will help both."

EHRevent is also working directly with EHR vendors as well as Regional Extension Centers (RECs), which are federally designated groups that assist physicians with EHR selection and adoption. Participating EHR vendors and RECs will help educate physicians regarding the importance of EHR event reporting and will receive reports as EHRevent partners.

"Patient safety is at the core of our mission to assist in the adoption of EHRs," explained Kathy Mechler, co-director and chief operating officer for the Texas A&M Health Science Center Rural and Community Health Institute, which includes the CentrEast REC. "We look forward to working with the many EHRevent partners to help educate providers and drive safe EHR adoption."

Michael Stearns, M.D., president and CEO of e-MDs, Inc., a leading EHR vendor, and board president of the Texas e-Health Alliance said, "EHRs have tremendous potential to improve the quality and efficiency of healthcare, but like any tool they must be designed and implemented in a way that uses best practices that strive to eliminate medical errors. We are anxious to collaborate with the EHRevent effort and we encourage all EHR vendors to participate because we believe that EHRevent can be an important communication platform to improve patient safety related not only to EHRs but to medical devices and drugs."

Data collected by EHRevent will also be used by the FDA to help evaluate any safety issues that may arise during the widespread implementation of this technology.

"We applaud the efforts of the iHealth Alliance to help assure the safety of EHRs," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "We look forward to working with the iHealth Alliance to encourage physicians and EHR vendors to report information on their experiences with electronic health records to EHRevent and other appropriate reporting systems."

EHRevent and a similar service for reporting adverse drug events via EHRs will be governed by the iHealth Alliance, with network operations provided by PDR Network. PDR Network CEO, Edward Fotsch, M.D. explained, "EHRevent, and RxEvent for adverse drug events, will collect information using online forms that include the Common Format developed by the Agency for Healthcare Research and Quality (AHRQ) and will keep the information confidential through PDR Secure, a Patient Safety Organization, allowing only participating organizations to access the reports.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care," said William Munier, M.D. Director for the Center for Quality Improvement and Patient Safety, AHRQ. "Patient Safety Organizations (PSOs) facilitate a shared-learning approach that supports effective interventions to reduce risk of harm to patients and improve quality. We are collaborating in efforts to facilitate reporting to PSOs those adverse events that are related to EHRs and other health information technology, in order to facilitate the development of safer health information technology solutions."

Starting today, U.S. physicians and other healthcare professionals will learn about and be encouraged to use EHRevent by their medical societies, liability carriers, the FDA, PDR Network and other participating groups.

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FDA approves Egrifta to treat Lipodystrophy in HIV patients

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.

"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," 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. “The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”

Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.

Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo). Some patients reported improvements in their self image.

The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.

Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.

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New Magnetic Resonance Imaging (MRI) Data Show Efficacy of SIMPONI® in Treatment of Rheumatoid Arthritis

/PRNewswire/ -- Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI® (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate. Changes in disease activity were measured using the Rheumatoid Arthritis MRI Scoring (RAMRIS) system, which assesses three components: synovitis, bone edema (osteitis) and bone erosions. Changes in RAMRIS scores were observed as early as week 12 and continued through week 24. These data were presented at the largest rheumatology medical meeting in the United States.

"MRI assessment has previously been demonstrated to show greater sensitivity than x-ray in detecting changes in inflammation and the structural integrity of the bone. The findings from a randomized controlled trial with a large number of patients show the value of this diagnostic tool in its ability to monitor disease progression" said Dr. Paul Emery, head of the Academic Unit of Musculoskeletal Medicine at the University of Leeds and lead study investigator. "The ultimate goals of inhibiting joint damage are to both reduce the symptoms that patients with RA experience and also to preserve patients' functional ability (which is correlated with early structural changes). These findings present important new information for rheumatologists and further support the substantial efficacy SIMPONI demonstrated in multiple Phase 3 registration trials in the treatment of this chronic disease."

Investigators reported that at week 24 of the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study, patients with RA receiving SIMPONI 50 mg plus methotrexate showed significant improvements in synovitis, bone edema and bone erosions [-2.2 (P = 0.011), -2.5 ( p <0.001) and -0.7 (p = 0.016), respectively], compared with patients receiving placebo plus methotrexate (-1.0, -0.3 and -0.2, respectively).

In a second study, GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD), patients receiving SIMPONI 50 mg plus methotrexate experienced significant improvements in synovitis and bone edema [-1.9 (p < 0.001) and -2.6 (p < 0.001), respectively] at week 24 when compared with the placebo plus methotrexate group (-0.4 and 0.7, respectively). Minimal changes in bone erosion across all treatment groups (mean change ranging from -1.1 to 0.4) precluded the adequate evaluation of the effects of SIMPONI on bone erosion, which is consistent with previously published radiographic data.

In September 2010, Centocor Ortho Biotech Inc. announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the SIMPONI physician label to include inhibiting the progression of structural damage in the treatment of moderately to severely active RA.

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FDA clears Cymbalta to treat chronic musculoskeletal pain

The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004.

“Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “This approval means that many of those people now have another treatment option.”

Since its initial approval, about 30 million patients in the United States have used Cymbalta. It was approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.

More than 29,000 patients have used Cymbalta in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety evaluation for Cymbalta included review of data from the clinical trials as well as post-marketing data from the previously approved patient populations.

The FDA assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

The most common side effects reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious side effects include liver damage, allergic reactions such as hives, rashes and/or swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior.

While these serious side effects have been associated with the use of Cymbalta, they have occurred in less than 1% of treated patients. There are a finite number of drugs available for the treatment of chronic musculoskeletal pain, all of which are associated with rare, serious side effects. There are patients in whom none of the available treatments are effective.

The recommended dose for Cymbalta is a 60 milligram capsule taken once daily without regard to meals. The capsule should be swallowed whole, and not chewed, crushed or opened; the contents should never be sprinkled on food or mixed with liquids.

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

Cymbalta is manufactured by Indianapolis-based Eli Lilly and Co.

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Home-Based Mindfulness Treatment Curbs Depression in Adults With Epilepsy

A telephone- and Internet-delivered mindfulness-based depression treatment has been shown to significantly reduce depressive symptoms in adults with epilepsy, according to a study by Emory University public health researchers, published in the November 2010 issue of Epilepsy & Behavior.

The treatment called UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based depression prevention and treatment program. Based on mindfulness-based cognitive therapy, the weekly program was designed for group delivery via the phone or Web. It involves eight, hour-long sessions focused on increasing knowledge about depression, epilepsy, cognitive-behavioral therapy (CBT) and mindfulness.

Forty participants were randomly assigned to participate in the intervention or waitlist groups. Depressive symptoms and other outcomes were measured at baseline, after eight weeks, and after 16 weeks.

Depressive symptoms decreased by 64 percent in the intervention group but only by 15 percent in the waitlist group. There was no significant difference in results between participants who received the intervention via telephone or Internet.

“The Project UPLIFT intervention was effective in teaching people with epilepsy the knowledge and skills associated with reducing their symptoms of depression,” says lead study author Nancy Thompson, PhD, associate professor of behavioral science and health education at Emory’s Rollins School of Public Health. “Addressing the mental health needs of this population is important as many people with epilepsy – between 32 percent and 48 percent – report being depressed as well as feeling isolated and stigmatized.”

Future studies of the UPLIFT program will target other populations at risk of depression, such as caregivers or persons with disabilities, who may benefit from a home-based treatment. The U.S. Centers for Disease Control and Prevention funded the Project UPLIFT pilot study.

In addition to Thompson, study authors were Elizabeth Reisinger Walker, Natasha Obolensky, Ashley Winning, Christina Barmon, and Colleen Dilorio, of the Rollins School of Public Health; and Michael Compton of the Emory School of Medicine.


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FDA Approves Teflaro for Bacterial Infections

The U.S. Food and Drug Administration today (October 29) approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

Teflaro is an antibacterial agent in a class of drugs known as cephalosporins, which act by interfering with the bacterial cell wall.

CABP is a bacterial infection that develops in the lungs of patients who are exposed to the bacteria in their normal environment, and not in the hospital. ABSSSI is a bacterial infection of skin and skin structures that requires antibiotic treatment and may require surgical treatment.

MRSA is a type of staph bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin, and amoxicillin. In the community, most MRSA infections are skin infections. Severe or potentially life-threatening MRSA infections occur most frequently among patients in contact with health care settings, according to the Centers for Disease Control and Prevention.

“These are serious and potentially life-threatening infections for which new treatment options are needed,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. “FDA is committed to facilitating new antibiotic drug development.”

The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI). In the CABP trials, the comparator antibacterial treatment was Rocephin (ceftriaxone) and in the ABSSSI trials, the comparator antibacterial treatment was Vancocin (vancomycin) plus Azactam (aztreonam).

In the CABP trials, 1,231 adult patients received Teflaro or Rocephin. Clinical response based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of Teflaro was comparable to Rocephin.

In the ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam. Clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint. In both trials, Teflaro was comparable to Vancocin plus Azactam.

The most commonly reported side effects in patients treated with Teflaro included diarrhea, nausea and rash. Teflaro should not be used in patients with sensitivities to cephalosporin antibiotics.

Teflaro is marketed by New York City-based Forest Laboratories.

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