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.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

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.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

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.

------
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

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.

------
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

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.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

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.
---
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
Facebook: http://facebook.com/ArtsAcrossGA
www.FayetteFrontPage.com
Twitter: @FayetteFP