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FDA Regulation May Squelch Development Of Some Medical Apps

We’ve been considering FDA oversight of medical apps for a while, over at Medgadget.com. Now, the public comment period has concluded on the FDA’s draft of how this oversight might look. The story:

The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:

* Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.

* Applications that allow the user to view patient-specific lab results.

* Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.

Great, right? The apps that do heavy lifting of patient information and connect to real medical devices get regulated, but the fun and educational apps I am working on remain free and open. Still, Harvey Castro, my favorite EM-doc-and-app-developer, was worried:

“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”

“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”

For their part, the FDA said it’s nothing to worry about: Read more »

*This blog post was originally published at Blogborygmi*

Fecal DNA Testing: Is This The Future Of Colon Cancer Screening?

It’s Saturday morning, and I’m in an undisclosed location drinking a fabulous cup of coffee while turning the pages of The New York Times, knowing that ink and newsprint will be vanishing too soon. Yes, I do have an iPad now, but I haven’t figured out how to blog on it. Any suggestions?

Buried in the first section of the paper is an article on stool, which in my view as a gastro specialist, should have merited front page placement. Yes, we all know the adage, ‘one’s man’s trash is another man’s treasure’, but stool – as in excrement – should be prized by everyone. Perhaps, as a gastroenterologist, I have a jaundiced view on this issue, which explains my dyspeptic reaction.

All Whistleblower posts have an accompanying image, and I wonder what visual would be appropriate here.  I opted against my first choice, and choose instead a photo of our beloved Labrador Retriever, Shoshie, of blessed memory.

The Times reported a new program to Read more »

*This blog post was originally published at MD Whistleblower*

Study Hopes To Help Those Seeking Breast Reconstruction Surgery

Jeffrey A. Ascherman, MD, FACS

Jeffrey A. Ascherman, MD, FACS

After the jubilation of beating cancer, many women who seek breast reconstruction have another journey to complete. Before they can receive a permanent breast implant, they must first undergo a process to create the space to house the new implant – a process which can be uncomfortable at times and may take many months.

“Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and sometimes uncomfortable saline injections every 2 to 3 weeks to create a pocket for the permanent implant following a mastectomy,” said Jeffrey Ascherman, MD, Site Chief, Division of Plastic Surgery, NewYork-Presbyterian/Columbia. According to some women, this process can also involve a significant time burden, since they must visit their doctor’s office every few weeks for an average of four to six months.

Dr. Ascherman is now the first physician in the United States to be enrolling patients in a study of a new, Read more »

*This blog post was originally published at Columbia University Department of Surgery Blog*

Avastin’s Approval Revoked: Harvard Health Publications Uncovers The FDA’s Process

Last week, the FDA revoked its 2008 approval of the drug Avastin to treat breast cancer, concluding that the drug does little to help women with breast cancer while putting them at risk for potentially life-threatening side effects. Avastin will remain on the market (and so be potentially available to women with breast cancer) because it has also been approved to treat other types of cancer.

In a statement, FDA Commissioner Margaret A. Hamburg said this:

FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use. After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.

Why does this happen? Read more »

*This blog post was originally published at Harvard Health Blog*

Preventing Surgical Fires

A month ago during a storm with significant straight line winds we had a tree near the house loss it’s top half.

Upon inspection, it turned out the pine tree was infested with pine beetles. We were encouraged to burn the debris to help protect the other trees from the beetles.

This past week my husband cut up the felled tree (we still need to get a tree cutter out to cut down the 2/3s of the tree still standing) and carried it to an area of the front property.  Yesterday morning after a light rain, he decided it was a good time to set it afire and burn it.  Note the red container under the tree to the left.  It contains gasoline.  [Even though he told me he wouldn’t use an accelerant.]  He did run a water hose down from the house which is barely visible in the forefront of the photo.

Medscape has a really nice article with video by Kenneth L. Silverstein, MD; Stephanie Josephon —  Surgical Fires: How They Start and How to Prevent Them: Read more »

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

Latest Interviews

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

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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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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