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Is The FDA Too Lenient When Reviewing Medical Devices?

I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with potholes and trapdoors and the analysis by the FDA is rigorous.

But for years we’ve been hearing that it is much less rigorous when it comes to medical devices. Artificial hip joints and stents to open blocked arteries fall into this category. And recently, the less stringent review process has been highlighted in the news. Metal-on-metal hip joints are being removed from patients who had them implanted. They thought Read more »

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

When To Accept That “The Beast” Is Winning

Steve Jobs in 2010

It was a bombshell that shouldn’t have been unexpected. Steve Jobs resigning. Anyone who saw him knew he was sick and, just watching him on television, it was obvious to me he was getting sicker. When you get so thin, when your color is not good, when you are probably taking heavy duty drugs that have side effects, you certainly don’t feel good. And when you don’t feel good, it is tough to think clearly, and make decisions with certainty. That is not a good thing for the CEO of one of the most successful corporations. It is actually a tribute to his will that he carried on so long. Many of the rest of us would be on a beach, taking it easy and celebrating every day. Steve Jobs celebrated every day by running Apple.

But at some point, given life is a terminal condition anyway, you have to accept that “the beast,” whatever it is in your case, is winning. I know that for myself. I have had a long remission with leukemia. But I know it could come back and even newer drugs might not “win.” I am thankful for the success treatment has had for so long. And I am sure Steve Jobs is thankful his diagnosis several years ago didn’t lead to his demise right then. We thank him, too, for iPhones and iPads and several other wonderful gizmos he has in the works that will blossom in the future.

Knowing when to call it quits – not accepting death – but accepting disability or a need to spend time differently – is a hard part of being a patient, it stinks. But it is reality. Read more »

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

Hospital CEO Is Diagnosed With Cancer While Building A New Cancer Center

Pat Elliott, me and a HUGE cactus at Banner MD Anderson!

I am just back from the Phoenix-metro area. It’s now the 5th largest in the United States and despite home foreclosures, there is still a feeling of growth in many areas. Gilbert, a nearby suburb, has expanded to over 200,000 people and a growing major medical center. I spent several days interviewing patients and staff about the soon-to-open, Banner MD Anderson Cancer Center. The hope is that by bringing MD Anderson’s world-renowned expertise, clinical trials and processes to this new center, cancer care around Phoenix and the southwest will be improved. Look for my video interviews coming soon.

But, in the meantime, one interview stuck out for me; the one with the Banner Health President and CEO, Peter Fine. Peter is in his late 50s and is a health care industry professional who has been guiding Banner Health and its 23 hospitals well for over a decade. For the past several years, Peter has been strategizing the building of a major cancer center on one of his hospital campuses. Peter knew he would need a renowned partner to make it successful and three years ago he chose MD Anderson Cancer Center, in Houston, consistently ranked as the nation’s #1 cancer center (and where I was treated in a leukemia clinical trial).

Even before the partnership contract was inked, a strange thing happened. Peter found a swollen lymph node in his neck and it didn’t go away. Read more »

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

New Cancer Treatment Gains Momentum

You heard about it first on Patient Power when, a couple of years ago, we interviewed Dr. Andrew Lowy, oncology surgeon at UC San Diego Medical Center. He explained how some patients with advanced cancer spread in their abdomen could benefit from an open surgery – perhaps as much as nine hours long – where, after snipping out visible cancer – the organs are bathed in heated chemotherapy for 90 minutes. You may recall the story of Jennifer Ambrose, a young mom from suburban Chicago, who developed cancer of the appendix. She tracked down Dr. Lowy after spotting him on the Internet. She traveled to San Diego, had the “hot chemo” procedure, recovered and then went on to have a second child – her “miracle baby.” Today Jennifer remains fine and her story is featured in my book, The Web-Savvy Patient.

Jennifer Ambrose’s Powerful Patient Video

Today Andrew Pollack, reporter for The New York Times, wrote a front page story about Dr. Lowy, hot chemo, and how other medical centers are now picking up on it for other advanced cancers including colon and ovarian. They are even advertising it as one last bit of hope when often there is virtually none. Now, some of the big names in GI cancers are suggesting this approach has merit and may offer longer survival then some super expensive drugs. There’s a debate going on. Read more »

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

Individualizing “The Fight Against Cancer”

You have heard it countless times, “The War on Cancer.” President Nixon announced it. The National Cancer Institute has spearheaded what TV and radio commercials always talk about as “the fight against cancer.” Singular. But we really need to start thinking about it as a plural.  Wars on cancer. Fights against cancer. Taking it one step further, we need to see each person’s fight as an individual battle.  Not just individualized to the patient’s spirit or age or sense of hope, but individualized to his or her particular biology, matched up with the specific cancer and available treatments. That is the nature of “personalized medicine” applied to cancer. We’ve been talking about it for a few years around here, but what’s exciting now is that even more super smart people in the cancer scientific community are devoting themselves to it.

I met two people like that today near the research labs at the University of Washington in Seattle. Without giving too much away (they’ve got big plans), these two hematologist-oncologists, with many advanced degrees between them and decades of experience, are trying to build something really big that could lengthen lives and save many too.

What they’re trying to do is Read more »

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

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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