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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*

Medical Security Breaches Are A Common Occurrence

It was kind of funny reading this recent article from the New York Times that focuses on a relatively small health data breach from Stanford Hospital’s emergency room:

A medical privacy breach involving Stanford Hospital in Palo Alto, Calif., led to the public posting of data for 20,000 emergency room patients, including names and diagnosis codes, on a commercial Web site for nearly a year, the hospital has confirmed.

Since discovering the breach last month, the hospital has been investigating how a detailed spreadsheet made its way from one of its vendors, a billing contractor identified as Multi-Specialty Collection Services, to a Web site called Student of Fortune, which allows students to solicit paid assistance with their schoolwork.

Gary Migdol, a spokesman for Stanford Hospital and Clinics, said the spreadsheet first appeared on the site on Sept. 9, 2010, as an attachment to a question about how to convert the data into a bar graph.

Although medical security breaches are not uncommon, the Stanford breach was notable for Read more »

*This blog post was originally published at Dr. Wes*

Can Pharmacogenomic Tests Help To Improve Public Health?

Adverse drug events are a serious public health problem. Consider the following facts:

  • an estimated 82% of American adults take at least one medication and 29% take five or more;
  • 700,000 emergency department visits and 120,000 hospitalizations are due to adverse drug events annually;
  • $3.5 billion is spent on extra medical costs of adverse drug events annually;
  • at least 40% of costs associated with adverse drug events occurring outside hospitals can be prevented.

How can genomics help? Pharmacogenomics is the study of genetic variation as a factor in drug response, affecting both safety and effectiveness. The intended applications of pharmacogenomics research include identifying responders and non-responders to medications, avoiding adverse events, optimizing drug dose and avoiding unnecessary healthcare costs.  The Food and Drug Administration has added pharmacogenomic information to the labeling for more than 70 drugs. Labels may include information on genetic determinants of clinical response or risk for adverse events.

In spite of current enthusiasm about pharmacogenomics in the research community, Read more »

*This blog post was originally published at Genomics and Health Impact Blog*

How Much Taxpayer Money Is Spent On Unnecessary Procedures?

“Doctors, with the consent of their patients, should be free to provide whatever care they agree is appropriate. But when the procedure arising from that judgment, however well intentioned, is not supported by evidence, the nation’s taxpayers should have no obligation to pay for it.”

So argues Dr. Rita Redberg, a cardiologist and professor of medicine at the University of California, in a provocative op-ed published in the New York Times. She writes that Medicare “spends a fortune each year on procedures that have no proven benefit and should not be covered” and offers the following examples:

“Medicare pays for routine screening colonoscopies in patients over 75 even though the United States Preventive Services Task Force, an independent panel of experts financed by the Department of Health and Human Services, advises against them (and against any colonoscopies for patients over 85), because it takes at least eight years to realize any benefits from the procedure.”

“The task force recommends against screening for prostate cancer in men 75 and older, and screening for cervical cancer in women 65 and older who have had a previous normal Pap smear, but Medicare spent more than Read more »

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

The “Dark Horse” Of HHS: Place Your Bets

Merrill Goozner has been speculating about who will be nominated as the new Secretary of HHS. He reviewed his most likely candidates (David Cutler or David Blumenthal), and threw in a “dark horse” potential nominee: Ken Thorpe (whom I’ve interviewed several times on this blog and spent time with during Obama’s inauguration ceremony).

Tommy Thompson told me that the nominee is likely to be a current or former democratic governor (such as Kathleen Sebelius or Howard Dean).

But I’ve been pondering the “long shot” question and think that Goozner may have missed a more obvious choice – someone who works with Ken Thorpe at the Partnership to Fight Chronic Disease: former Surgeon General Dr. Richard Carmona.

Here are the 10 reasons why Richard Carmona would be a smart choice for Secretary of HHS (in random order):

1.    He was confirmed by the senate as Surgeon General in 2002 and lived under their scrutiny during his term of service, meaning he has no hidden secrets, tax or nanny problems likely to embarrass Obama and could be confirmed rapidly – perhaps in under a week.
2.    He has forged extensive good relationships with both parties over the course of his tenure as Surgeon General and is known internationally.
3.    He has been the CEO of a large, public health system (including hospitals, Medicare and Medicaid clinics, nursing homes, and emergency medical systems in Arizona).
4.    He has been a paramedic, nurse, and physician and understands the healthcare system from the inside out.
5.    He has a track record of leadership in prevention, preparedness, health disparities, health literacy, global health and health diplomacy. He has worked on both sides of the aisle, including assisting Senator Kennedy with issues of disability and socio-economic determinants of health.
6.    He is Hispanic, which adds additional diversity to the Obama leadership team.
7.    He has experience managing local, state and federal health programs, including significant experience in immigration and border health issues.
8.    He demonstrated competency and leadership as manager of the US Public Health Service of over 6000 uniformed public health officers both nationally and internationally.
9.    He has extensive military experience, and is a combat-decorated Vietnam veteran. He maintains a strong relationship with military surgeons general and the department of defense.
10.    The fact that he is a political independent might actually provide a middle ground for parties with differing agendas in health reform.

Is point number 10 a deal breaker? It may be, but Obama could look farther and do much worse. And while the clock is ticking and credibility is paramount (as Maggie Mahar wrote, “Reform needs to be overseen by someone who is perceived as being above suspicion—purer than Caesar’s wife”) I think the Obama/Biden team needs to take a closer look at Dr. Carmona. He’s actually the most experienced, low risk candidate under discussion – and could truly hit the ground running at HHS. And wouldn’t it be nice to have a physician who is also a health policy expert with advanced managerial experience at the head of the healthcare reform table?

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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