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Meta-Analyses And A Capricious Drug Approval Process: The Actos And Avandia Stories

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Both Germany and France have now suspended the marketing of Actos (pioglitazone) due to concerns of a link between Actos and bladder cancer. Though we have known about bladder cancer concerns for some time, these recent concerns about the bladder cancer link stem from a recent report analyzing the FDA’s Adverse Event Reporting System (AERS), which found that 93 cases of cancer were recorded between 2004 and 2009 in patients treated with antidiabetic drugs, of which 31 patients were treated with pioglitazone, representing a statistically significant increased risk of bladder cancer (ROR 4.30, 95% confidence interval, 2.82-6.52; P less than 0.0001).

Interestingly, the FDA announced that it was going to look into the link between Actos and bladder cancer only a few days before it made its final decision on what to do with Avandia (as if they didn’t know about the Actos cancer risk before the July 2010 advisory board).

Despite the many things you have heard about Avandia, back in July 2010, the FDA decided to severely restrict the use of Avandia for three reasons: Read more »

*This blog post was originally published at ACP Internist*

A FICO Score For Medication Compliance?

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In Keeping Score on How You Take Your Medicine, Tara Parker-Pope of the New York Times, reports on a new initiative from the Fair Isaac Corporation (FICO) known previously for its credit score ratings.  FICO has developed a Medication Adherence Score, using publicly identifiable information (like employment status, age and gender) to determine a patient’s score, which it says “can predict which patients are at highest risk for skipping or incorrectly using prescription medications.”

Parker-Pope reports, “By the end of the year, an estimated two million to three million patients will have been given a FICO medication adherence score and a total of 10 million patients are expected to be scored during the next 12 months…FICO officials say insurance companies and other health care groups will use the score to identify those patients who could benefit the most from follow-up phone calls, letters and e-mails to encourage proper use of medication.”

The FICO medication adherence score has not received a universally warm reception: e-Patient Dave and Society for Participatory Medicine member Alexandra Albin point out that the score only accounts for whether prescriptions are purchased, not whether the pills have actually been taken.

In a related effort, Geisinger Health Systems and CVS Caremark are conducting a study to assess whether enhanced doctor-pharmacist communication can help with medication adherence.  Shefali S. Kukarni reports in Tracking Down Patients Who Skip Their Drugs that, “The 18-month investigation will track a prescription from the moment it is submitted electronically to the pharmacy until it reaches the patient. If the patient does not pick up the prescription a ‘red flag’ or some form of notification will be sent to the doctor.”

But as Jessie Gruman recently blogged, there is no magic pill to cure poor medication adherence.   Read more »

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

Podcast With Regina Herzlinger: No Single Organization Can Effectively And Efficiently Manage Healthcare For A Population Of Patients

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I spoke with Harvard Business School professor Regina Herzlinger this week about health reform – the good, the bad and the ugly – touching on ACOs and demonstration projects under the Affordable Care Act; innovations coming down the pike in the private sector either because of the law or because of market forces; social media in health care; and two key fixes to the ACA that she believes are absolutely necessary in order to make it work, or work as best it can.

First of all, she expressed her delight at the passage of a federal law nudging us ever closer to universal coverage, combined with dismay at its failure to address rising costs (noting that we’re looking at policies yielding an accumulated Medicare deficit of $90 trillion, as compared to an annual GDP of $12-14 trillion) and at the paltry fines to be leveled at noncompliant employers that do not offer health insurance as required. As rational actors, she expects that more and more employers will simply opt out of the health care insurance market one way or another: Read more »

*This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog*

Doctors And Patients Will Be Harmed By The Debt Ceiling Train Wreck

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Watching the negotiations over the debt ceiling legislation is like watching an impending train wreck.

You see a train hurtling down the track, you see an unobservant trucker about to cross, you know that the train engineer and the truck driver have only a few moments to avert disaster, you try to yell and scream to get them to pay attention before disaster strikes—but you have this sinking feeling that your voice won’t be heard until it is too late.

Well, that is how I feel watching the collapsing negotiations over raising the debt ceiling. Responsible persons in both political parties know that a failure by Congress to authorize an increase in the debt ceiling will create incalculable harm to our country, even though some politicians seem to think that default would be no big deal.

But it would be a big deal, and here is why. Read more »

*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*

Medical Judgment Trumps Medical Innovation

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The New York Times says “In Medicine, New Isn’t Always Improved.”

Who can argue with this?

“In Dining, New Restaurants Aren’t Always Better.”

Yes, that’s true, too.  But does it mean anything?

The article is about a type of hip that is apparently going to be the focus of a lawsuit.  The story goes that a lot of people wanted the new hip when it came out, because it was thought to be better than the older ones.  Unfortunately, the hip seems to have hurt some people, some of whom may have been better off getting the older one in the first place.

A doctor quoted in the article suggests it’s part of a uniquely American tic.  We want all of the latest and greatest things for ourselves, it seems.  This story is supposed to be a cautionary tale of what can go wrong when we do.

On the other hand, the latest and greatest things don’t appear out of nowhere.  In America, when people demand something, there will be someone who supplies it. Read more »

*This blog post was originally published at See First 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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