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FDA Requires Label Changes For The Patch

After cautiously clearing Yaz for continued use Thursday, an FDA Advisory Panel Friday addressed post-marketing data showing similarly increased blood clot risks among users of the contraceptive patch.  The committee, after having been clearly quite  extensively briefed,  heard testimony from Ortho Evra’s  manufacturer and experts in epidemiology, gynecology and hematology. They also heard moving testimony about  a young woman who died from a massive pulmonary embolism while using the Nuvaring, whose parents argued that not only the Patch, but most of the newer methods carry an increased clot risk that no woman should be allowed to take without being adequately informed.

The committee ruled that despite limitations of the data, the patch most likely carried a 1.5 times relative risk of blood clots compared to 2nd generation levonogestrel pills, but not necessarily higher than that of newer pills containing 3rd and 4th generation progestins and drosperinone.  With a few dissenters, the committee voted to allow the Patch to stay on the market, but asked for Read more »

*This blog post was originally published at The Blog That Ate Manhattan*

Building Programs For People Living With Serious Conditions

I can’t get the 1989 baseball movie Field of Dreams out of my head. That’s especially true right now as I can’t wait for the seventh game of the World Series. My son, Eitan, and I sat on the couch and watched the sixth game last night and it was probably the most exciting game I’ve ever seen. Plot twists galore. You can bet the audience for tonight’s game will be HUGE.

What’s so cool in thinking back about the movie is the famous line said to the baseball fanatic farmer: “If you build it they will come.” So he built a baseball field behind his house and the greats of baseball history came to play. I have never forgotten that line and have applied it to what we “build” at Patient Power – interview programs for people living with serious health concerns.

In the past few weeks, and continuing from now on, we have been focusing on two blood-related cancers: multiple myeloma and chronic myelogenous leukemia. While there are other educational resources out there, people living with these serious conditions always want more – as well they should. Fortunately, Read more »

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

We Are All Patients

We are all patients, damnit.Two weeks ago, I attended my third year at Kru Research’s ePatient Connections conference, and every year, I’m amazed at how many different industry people show up and showcase their impressive efforts … but how few patients.  But this year, there were a lot of patients.  Lots as in “more than five.”

For a conference with “ePatient” in the title, it was good to finally see more than just a handful of ePatients in the audience.  (And this is thanks, largely in part, to the ePatient Bill of Rights project that took place on September 19th, across the hall from the SXSH event).  And it wasn’t just a handful of diabetes patients – there were many health conditions well-represented at these events.  For me, it was nice to talk about the universal issues that people with chronic illnesses face, instead of drifting around in the bubble of diabetes.  I like stepping outside of our comfortable space and learning about what others are living with.  I need that exposure to other types of patients … keeps me thinking globally.

Part of the panel discussion Read more »

*This blog post was originally published at Six Until Me.*

What Should People Receiving Health Care Be Called? Empowered Patient Vs. Health Care Consumer

“There is a better way – structural reforms that empower patients with greater choices and increase the role of competition in the health-care marketplace.” Rep. Paul Ryan (R-WI) August 3, 2011

The highly charged political debates about reforming American health care have provided tempting opportunities to rename the people who receive health services.  But because the impetus for this change has been prompted by cost and quality concerns of health care payers, researchers and policy experts rather than emanating from us out of our own needs, some odd words have been called into service.  Two phrases commonly used to describe us convey meanings that mischaracterize our experiences and undervalue our needs: “empowered patient” and “health care consumer.”

As one who has done serious time as a patient and who spends serious time listening to talks and reading the literature that use these words to describe us, I ask you to reconsider their use.

“Empowered patient” The fabrication of the verb “to empower” from the noun “power” was used in the civil rights and community development movements to describe a benevolent bestowal of influence on disenfranchised individuals and groups by those who had previously excluded them.  When used in relation to health care, the word perpetuates the idea that we are passive entities, waiting to be gratefully endowed by our clinician or a new policy with the right and ability to act on our own behalf.  Our “empowerment” takes place not as a result of our own will or preference, but rather because we have been given permission to act in a different way by some external agent.

This word is Read more »

*This blog post was originally published at Prepared Patient Forum: What It Takes Blog*