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FDA Actively Monitoring Medical And Healthcare Apps

Bradley Merrill Thompson, an attorney with expertise in the FDA approval process for medical devices, is stating that the FDA is actively monitoring app stores on various platforms. Regulating medical devices and health care-related applications falls under the FDA’s jurisdiction.

James Kendrick from JkOnTheRun spoke with Thompson, where he stated the following:

The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.

By “various app stores,” Thompson is likely referring to the App store [Apple], Palm App Catalog [Web OS], App World [BlackBerry], and the Android Marketplace [Android OS]. Read more »

*This blog post was originally published at iMedicalApps*

Avastin For Breast Cancer: Will The FDA Revoke It?

Time to get back up on my soap box.

Next month the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month.

The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing.

Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other cancers. The problem comes with breast cancer. Read more »

*This blog post was originally published at A Medical Writer's Musings on Medicine, Health Care, and the Writing Life*

FDA Warning: Industrial Bleach As A Cure For Cancer And HIV?

On the heels of Scott Gavura’s superb post on dietary supplement regulation in the U.S. and Canada, I bring you one of the most egregious and obscene product cases I have seen in 15 years of teaching on botanical and non-botanical products: Miracle Mineral Solution. Please accept my apologies in advance for not having a scholarly post for you — this is just too unbelievable not to share with science-based medicine readers. Read more »

*This blog post was originally published at Science-Based Medicine*

Drug To Treat Spider Veins: Asclera Now FDA-Approved

The FDA recently (March 2010) approved Asclera (poliocanol) injection for the treatment of small spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter).

Asclera is a detergent sclerosant and produces endothelial damage through interference with the cell’s surface lipids.and acts by damaging the cell lining of blood vessels. This causes the blood vessel to close, and it is eventually replaced by other types of tissue. Read more »

*This blog post was originally published at Suture for a Living*

Food And Pesticides: The Dirty Dozen

Fruits and VegetablesThe Environmental Working Group (EWG) is a non-profit focused on public health. We know that the long-term consequences of eating chemicals from pesticides used on our foods is damaging to our health.

The EWG analyzed data from the FDA and found that people who eat five fruits and vegetables a day from the “Dirty Dozen” are eating 10 pesticides a day. We want people to eat more fruits and vegetables, but NOT to ingest more chemicals. Rinsing reduces but does not eliminate pesticides. So what’s the answer? Rinse completely and buy the “Dirty Dozen” foods organic whenever possible. Read more »

*This blog post was originally published at EverythingHealth*

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IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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