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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*

Cancer Drug Has Potential To Treat Chronic Ear Infections

I read with astonishment that a class of cancer drugs known as VEGF Inhibitors (ie, Avastin and Erbitux) used to treat colorectal, lung, breast, and kidney cancers can also be used to potentially treat a type of chronic ear infection known as glue ear… at least in theory and in mice. Glue ear is when an individual suffers from repetitive ear infections or upper respiratory infections to the point where the fluid in the ear turns into a maple syrup consistency. It’s thick, sticky and tough to get rid of with standard antibiotic medications. Standard treatment to address glue ear is placement of ear tubes to allow ventilation and drainage of the ear as well as antibiotic/steroid ear drops.

British researchers using the mouse model have determined that Read more »

*This blog post was originally published at Fauquier ENT Blog*

NASA Research Has Positive Implications For Motion Sickness Treatment

So how would one go about figuring out the best medication for dizziness due to motion-sickness leading to nausea and even vomiting?

Well, step 1… Put a bunch of people in a machine and figure out the necessary motions that will cause dizziness.

Step 2… Do the same thing, but this time, put people on different medications and figure out what works the best.

Sound crazy?

Well it has been done by the friendly folks at NASA. Read more »

*This blog post was originally published at Fauquier ENT Blog*

Should Pharmaceutical Companies Get Involved In Social Media?

Imagine you’re a pharmaceutical company product manager and your specific product helps people with a chronic illness, or a cancer that can be managed by taking a pill or an injectable medicine over many years. You want to be part of the dialogue patients have with each other. You want to be part of the community. Facebook users, and other social media participants, are increasingly forming groups around health conditions, big and small. You want to be there, because, after all, your company has invested hundreds of millions of dollars developing the approved drug and hopes this medicine, and perhaps a successor, will be on the market for a long time.

This is an exciting time on the Internet and pharmaceutical product managers want to be part of health discussions. But it is fraught with legal pitfalls and penalties that can range into the millions of dollars if the product manager, or associated marketing agencies, make even an innocent mistake. Read more »

*This blog post was originally published at Andrew's Blog*

E-Messages Sent When Pill Is Swallowed

University of Florida researchers have developed a signaling technology that can be embedded into drug tablets to notify clinicians and caretakers that a pill has been ingested.

Although a bit of electronics is going to be moving through the digestive system, the researchers believe that it will pass safely without causing side effects to the patient.

If the technology proves itself, it may soon be used to confirm compliance in clinical trials or to monitor patients under a strict drug regimen.

One part is the pill, a standard white capsule coated with a label embossed with silvery lines. The lines comprise the antenna, which is printed using ink made of non-toxic, conductive silver nanoparticles. The pill also contains a tiny microchip, one about the size of a period on paper. Read more »

*This blog post was originally published at Medgadget*

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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