FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

Accelerated approval process used in flu vaccine approval

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Babble.com image

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

Click here to read the rest of this FDA seasonal flu press release

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H1N1 Swine Flu Update

Skin Cancer : Epidemic From The Sun

by David B. Schulman M.D., F.A.A.D.

There is a true epidemic of skin cancer in America. One million cases of skin cancer will occur this year in America. Lifelong sun exposure is increasing for Americans as we spend more time outdoors and the sun’s rays are becoming more intense with our loss of ozone. The use of tanning booths is a new way to further damage our skin and raise our risk for skin cancers. There are three common forms of skin cancer and we are seeing dramatic annual increases in the number of these skin cancers. Melanoma, which is the most aggressive form of skin cancer, is now the most common cause of cancer deaths in American women under forty years old.

Basal Cell Carcinoma The most common and least aggressive form of skin cancer is basal cell carcinoma. This is the most common cancer in America and happily it causes nearly no fatalities. This cancer is most common on light skinned people and thirty percent of Caucasian people in America are expected to have a basal cell in their lifetime. The great majority of basal cell carcinomas will occur on the head and neck. Though this form of cancer almost never enters the bloodstream or the lymph system, it may be locally invasive. Basal cells do grow by local extension and over time can erode and invade not just skin, but other important areas down to muscle or bone. There are more aggressive forms of basal cell carcinoma that will infiltrate and extend below the surface more than above the surface. These tumors are especially dangerous for the surrounding tissue. Basal cell tumors often appear as pale or translucent patches or raised bumps on the skin with fine blood vessels in them. They may grow for months or years without detection. The often ulcerate and bleed as they grow, but otherwise have no symptoms like itching or pain. The tendency towards growing basal cells is inherited and many patients report at least one family member with a history of basal cell. Patients will often have more than one basal cell in their lifetime and I have seen patients who have had dozens of them. Darker skin tends to get fewer basal cells but one of the first lesions I had in my new practice was an African-American women with a basal cell on the leg. She is fine and nearly everyone who has this is fine. With early detection and removal this should simply be a speed bump on the road of life.

Study Finds No Link Between Cell Phones, Tumors – Cancer

A very large, 30-year study of just about everyone in Scandinavia shows no link between cellphone use and brain tumors, researchers reported on Thursday.

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Citizen.org image

Even though mobile telephone use soared in the 1990s and afterward, brain tumors did not become any more common during this time, the researchers reported in the Journal of the National Cancer Institute.

Some activist groups and a few researchers have raised concerns about a link between cellphones and several kinds of cancer, including brain tumors, although years of research have failed to establish a connection.

“We did not detect any clear change in the long-term time trends in the incidence of brain tumors from 1998 to 2003 in any subgroup,” Isabelle Deltour of the Danish Cancer Society and colleagues wrote.

Deltour’s team analyzed annual incidence rates of two types of brain tumor — glioma and meningioma — among adults aged 20 to 79 from Denmark, Finland, Norway, and Sweden from 1974 to 2003. These countries all have good cancer registries that keep a tally of known cancer cases.

This represented virtually the entire adult population of 16 million people, they said.

Click here to read the rest of the article from FoxNews.com

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Scientists Create Heart Cells from Skin Cells

(IsraelNN.com) Israeli scientists have discovered a way to create beating heart cells using human skin cells reprogrammed to become stem cells. The findings could lead to advances in disease research, and could in theory be used to repair damaged or diseased tissues.

Lior Gepstein IsrealNN.com photo

Published in the latest issue of Circulation, the findings by Professor Lior Gepstein of the Technion-Israel Institute of Technology could make it possible to clinically repair damaged human hearts.

Such an application is at least 10 to 20 years away, says Gepstein, but the process can already be utilized for in-depth study of genetic diseases and the development of personalized drugs for irregular heartbeats and other inherited disorders.

Transforming our cells through reprogramming

The team’s work is based on the research of Japanese scientists followed by other groups, who generated “induced pluripotent stem cells” (iPSCs) from adult mouse and human skin cells. The iPSCs can be turned into almost any type of body cell – something that experts previously thought possible only with embryonic stem cells – and could, in theory, be used to repair damaged or diseased tissues.

Taking a patient’s own cells and turning them into iPSCs for use in tissue repair and regeneration would also eliminate the risk of rejection by the body.

Gepstein and his team from Technion’s Rappaport Faculty of Medicine and Rambam Medical Center used reprogrammed iPSCs derived from healthy human subjects’ skin cells with the characteristics of pluripotent embryonic stem cells. They were then able to convert them into heart cells with all the necessary properties such as expression of heart-related genes, spontaneous electrical activity, mechanical contraction, and response to various hormones such as adrenaline.

According to Gepstein, the rejuvenation of human cells and their transformation into iPSCs can be accomplished with almost any human cell.

Making heart headlines


Nearly eight years ago, Gepstein and colleagues made headlines by creating beating cardiac tissue in the lab from human embryonic stem cells. In 2007, he teamed with the Technion’s Dr. Shulamit Levenberg to create tiny blood vessels within the tissue. This breakthrough could eventually make it possible to implant the tissue in a diseased human heart.

The findings could also someday lead to advances in research on diseases caused by single-gene mutations. The list of these diseases includes familial arrhythmogenic syndromes leading to irregular heartbeat and sudden cardiac death, cardiomyopathies that weaken the heart muscle, and several neurodegenerative disorders.

Certain challenges exist, however. One hazard of using iPSCs as well as ordinary embryonic stem cells is the possibility that the cells will begin to divide wildly and turn cancerous. As a result, “it will be years before they are used clinically,” says Gepstein. While animal studies could eventually lead to clinical work, scientists would first have to learn how to make large amounts of the iPSC-derived heart cells, he concludes.