How 23andMe brought down the FDA's wrath | The Verge →

Russell Brandom:

The mere fact that 23andMe was able to operate for six years without marketing approval speaks to how much leeway the FDA was willing to extend at first, especially while many doctor’s groups were skeptical of personal genetics from the beginning…

23andMe didn’t invent the saliva test, after all. All it did was bring such testing outside the doctor’s office and make it available without the headaches of the health-insurance system. It was a consumer-grade version of a professional service: cheaper, easier, and not quite as good. And because the testing could be done in bulk, the service added a lot of genes that would never be tested in a medical lab…But that same fast-and-loose approach can cause problems if a faulty test turns up in an area with real medical complications…And when the bad news does arrive…23andMe didn’t have any counselors on hand to guide users to the medical options available or provide the proper context for understanding the results. Even if the service solves its marketing problems, those issues are likely to remain.

This is probably the best article I’ve read on 23andMe and the FDA’s action. For all intents and purposes, 23andMe seemed more concerned with pursuing its product than dealing with the implications of putting complex medical information into consumers’ hands.

My deadly disease was just a 23andMe bug | @mntmn →

Once the news of the FDA’s action against 23andMe came out, it was only a matter of time before stories of errors using the service surfaced. This particular story is very interesting because of how deep this person went to identify the problem–dowloading the raw 23andMe data, using other pieces of software to parse it, and ultimately discovering he DID have two mutations for limb-girdle muscular dystrophy but they were on two different genes.

Do stories like this put the FDA in the right? Should 23andMe be shutdown for good? Do we need to end the pursuit of direct-to-consumer genomics services? It’s unclear right now. These are complicated issues which require time and thought before settling on a path to find answers.

Bonus—Check out the Hacker New comments for more discussion/entertainment.

Art Makes You Smart | NY Times →

We often say medicine is both science and art; don't forget to study the art part of it...and art in general. One of the best things TEDMED does is incorporate art and medicine.

Flu Drugs Fall in Use for Children | NY Times →

Such a poorly worded headline with emphasis on the wrong finding.

A study published today in Pediatrics showed reduced mortality when neuraminidase-inhibitors (think oseltamivir/Tamiflu) were used in children hospitalized in the ICU with influenza. This is some of the best evidence yet that early intervention with antivirals impacts outcomes for children with influenza. This study also found--which the headline alludes to--that use of neuraminidase-inhibitors has fallen since 2009.

Sorry for the 'flu-heavy' day...

The Quest to End the Flu | The Atlantic →

The mytical ‘universal influenza vaccine’ rears its head once again. I first became interested in influenza during graduate school in 2005. Human cases of avian influenza were being reported and the work on sequencing the 1918 pandemic strain had recently concluded. I remember some talk about a universal flu vaccine back then [1], but have never seen much concrete work [2]. For those not very familiar with influenza and the vaccine difficulties, this article represents an excellent primer.

  1. Talk of a universal influenza vaccine likely goes back well beyond 2005; I’m not familiar with when such ideas were proposed.  ↩

  2. Admittedly, I don’t pay much attention to flu basic science research.  ↩

My experience with AliveCor ECG and Twitter | iDoctr →

Fascinating detailed account of one doctor’s experiences with the AliveCor in his day-to-day life. I especially enjoyed him recounting how he used the AliveCor to monitor a 17 year-old boy while he attempted to stop supraventricular tachycardia with carotid massage in his living room. I think this represented an instance where the AliveCor demonstrated clear utility.

✚ The fallacy of the 'Smartphone Physical'

Singularity Hub recently featured a post on the ‘Smartphone Physical’, a concept debuted at TEDMED 2013. While I commend the two medical students who conceptualized the Smartphone Physical, I am not as enthusiastic about it’s potential impact on patient care as many of its supporters. The so-called Smartphone Physical involves much more than a smartphone and provides much less information than that collected by a physician during a physical.

A physical is more than measurement—Walk into any doctor’s office for any kind of physical and they will do more than just measure your vital signs and take a look at you through their special scopes. Arguably, the most important part of a physical is taking a detailed history, as it is with any medical encounter. Simply speaking with a patient about what has been going on with them for the past year or more reveals far more than anything displayed on a smartphone. Experienced clinicians know the right questions to ask and how to ask them. Such clinicians are also skilled in the physical exam. While some components of the physical exam include the use of specialized equipment, most of it is accomplished through the clinician’s unaided senses.

The ‘Smartphone Physical’ requires much more than a smartphone—Of the ten components included in the Smartphone Physical, only one does not require an additional piece of equipment. While the creators list “expense” as one of the limitations of the traditional physical exam, I think one look at the Welch Allyn iExaminer puts the ‘Smartphone Physical’ in perspective. It retails at $80 for a piece of molded plastic and they ask for another $30 for the “pro” version of their accompanying app (in-app purchase). Or take the AlivCor Heart Monitor, it retails for $200. Then we have the $7,500 or more you have to shell out for the MobiSante ultrasound device (admittedly much cheaper than most ultrasound machines). All told, putting together a “digital doctor’s bag” with the devices included in the ‘Smartphone Physical’ would cost you over $8,300 (for those devices that are commercially available at this time). Also, be aware that many of these accessories are device specific and may need to be replaced as smartphones change (i.e.–Welch Allyn’s iExaminer only fits the iPhone 4/4S; the AliveCor Heart Monitor has separate cases for the iPhone4/4S and iPhone 5).

The data remains siloed—None of these devices, as far as I can tell, has any sort of integration with common electronic medical records. To be fair, this is not the sole fault of the creators; I am unaware of any EMRs that have data APIs that would allow people to send data from a smartphone app to an EMR. However, this is where there is some true promise. Adding objective data from the physical exam directly to the EMR would be of great benefit. Actual pictures of optic discs and ear drums would be of very beneficial for documenting the acute presentation and progression of disease.

Nothing here is new—With the exception of the NETRA-G and the recently added Biomeme qPCR Molecular Diagnostic, nothing in the ‘Smartphone Physical’ is particularly innovative. We have had electronic devices to take vital signs for a long time, cameras exist for all medical scopes, and we obviously have EKG, spirometry, and ultrasound machines. The common thread among these devices is reduced cost, which I would argue is evolutionary not revolutionary. Non-smartphone based versions of these devices would be low-cost if their manufacturers thought there was a broad-based consumer market to be exploited.

What consistently bothers me most about the ‘Smartphone Physical’ is the hyperbole surrounding it. A quick perusal of the headlines from the ‘Smartphone Physical’ media page gives you a flavor for this. Many times in the media and even on the TEDMED stage, people alluded to a checkup or physical from a smartphone [1]. As I explained above, that couldn’t be further from the truth. No matter how many accessories we connect to a smartphone, the physical will remain the purview of an experienced clinician.

I look forward to seeing these devices evolve, but the true innovation will be integration of objective clinical data with the patient’s subjective experience and augmented with longitudinal data from personal devices, stored in a single electronic record.

[Note–A version of this post appeared on my previous blog.]

  1. Fast Co Exist, “If we’re able to monitor our vital signs, we may not need doctors for check-ups.” (1) You can already monitor your vital signs at home, without smartphone-based equipment. (2) If all your doctor is doing during a visit is monitoring your vital signs, find a new doctor.  ↩

Pharmacogenetics Puzzle | The Scientist →

Nice summary of recent research results showing the questionable utility of screening patients for CYP2C9 and VKORC1 variants when initiating warfarin therapy. This goes along with my previous post about Boston Children’s efforts in pharmacogenomics.

We are in the early stages of making pharmacogenomics clinically useful. There are going to be bumps in the road, one of the biggest being we find out that knowing certain gene variations doesn’t impact clinical care.

The ePrognosis App: How Calculating Life Expectancy Can Influence Healthcare Decision-Making | The Health Care Blog →

Leslie Kernisan MD MPH:

In general, the ePrognosis story illustrates a common challenge in improving healthcare quality: the problems that experts see at the population level (excess cancer screening in frail elders) are experienced very differently by the clinicians and patients on the ground...Although expert guidelines and advice do have an important role to play, it’s usually not nearly enough to counter the habits and attitudes of the people in the trenches.

This is an interesting tale of creating a smartphone app to put evidence-based information in physicians' hands at the point of care (something I've tried to do myself). What I think Dr Kernisan is trying to get at in the quote above is that it's very difficult to persuade experienced clinicians to not rely on their training and experience, to instead use a digital tool for clinical decision support. One reason for this, I believe, is that we overestimate our performance. Decision-support tools are created because there is some population-based evidence for poor performance on some measure (at least that's the general idea). To make their usefulness 'real' for ordinary physicians, they need to see their own performance on those measures and the clinical impact of better performance.

The Pros and Cons of E-Communication | The American Resident Project →

Great topic and initial list of some of the benefits and downsides to communicating with patient through electronic means. I think they missed one major one.

  • Potential for misunderstanding. Written communication is asynchronous and limited in scope and length. This means there is tremendous potential for miscommunication. Verbal cues such as tone are absent. Visual cues, namely body language,  are also absent. A doctor can't see a patient's confused face and know to use less jargon or go deeper. A patient can't hear the seriousness of the doctor's tone. Neither party can easily ask follow-up questions.

Electronic forms of communication will absolutely be part of the future in medicine. However, we must be vigilant for misunderstanding. Many of us are not great communicators in written form; many of us don't read carefully enough. There will always be a place for face-to-face communication between doctor and patient.

We need more residency positions | Med Rants →

Robert Centor MD:

Oops – the author does not know a thing about medical school admission increases – and yet he opines as if he has discovered the answer! Ask any US grad about the increased number of US medical school graduates. Ask the 300+ graduates of last years class who did not get a residency slot!

Pre-Med Students Readjust Concentration Choices | Harvard Crimson →

Setting aside the sanctimonious undertones [1], this article raises an interesting question—will the changes to the MCAT and premed requirements mean more diversity in terms of major for med school applicants? I think it may have a minor impact. The bulk of the MCAT still remains focused on traditional ‘hard’ sciences and most students will still be counseled to choose such a major [2]. Major shifts will require cultural shifts within medicine itself and med school curricula.

[via Wing of Zock]

  1. “While other schools are struggling to figure out which classes provide which competencies, we’re good…It’s what is known colloquially as people skills."  ↩

  2. I don’t mean by premed counselors at undergraduate schools, but rather current physicians and medical professionals who often serve as informal mentors/advisors for med school hopefuls. I would hope that university-based premed counselors do a rigorous job discussing with students the option to choose a non-science major.  ↩

Primary care suffers from guideline overload | KevinMD →

Great insights from Paul Bergl MD, a chief resident and contributor to a NEJM Journal Watch blog. He briefly touches on something I think is critical to achieving his overarching goal of dealing with information overload—research and data evaluation skills. We simply do not provide enough training in med school and residency to empower young physicians to critically evaluate the literature. Without confidence in these skills and little time in the first place to critically read publications, it becomes an impossible task to deal with all of the information.

He also writes:

Our experts in evidence-based medicine need to guide us toward the most relevant and pressing needs, guidelines about guidelines, so to speak. We need our educational and policy leaders to help reign in the proliferation of practice guidelines rather than continuing to disseminate them.

This needs to happen on a local level. Academic medical centers can be the drivers of curating this information for their city, region, or state. Of course, this type of work is not reimbursed, but it should be part of the academic medical center’s mission and their sense of responsibility to the community.

Think you have strep? Answer two questions and check the big data | Vector blog →

Researchers at Boston Children’s Hospital are working on a system that incorporates local microbiology data with two easy questions patients can ask themselves to predict whether or not they should see a doctor.

We need more innovation like this, especially in terms of infectious diseases. Knowing the local burden of a given infection can dramatically improve diagnostic testing performance and inform whether or not such testing should be conducted [1]. Unfortunately, infection data is all too often siloed in hospital and clinic microbiology lab data.

  1. Remember from your basic epidemiology that positive predictive value is dependent on the prevalence of the disease. So, if we know there is a high prevalence of strep throat in the community based on local infection data, the predictive value of simple questions and even rapid strep tests increases.  ↩

Whose Data Is It Anyway? | The Health Care Blog →

Wow, electronic medical record vendors claim ownership of all of the data entered into their systems. It’s like if everything you wrote in Microsoft Word was owned by Microsoft [1]. I have heard of some of the big EMR companies creating ‘exchanges’ where they aggregate data from various hospitals for research. At the time, I thought that was strange and curious how they were able to do it with HIPAA. This is how.

  1. Google claimed similar ownership over data and files when it launched Google Drive. People were not happy at the time, but nobody talks about it anymore.  ↩

Hot Spotting - Innovative Approaches to Caring for the Very Ill | Wing of Zock →

Interview with Jeffrey Brenner MD, executive director of the Camden Coalition of Healthcare Providers and one of the persons behind hotspotting.

Dr Brenner:

Sit down at the foot of the bed, ask patients open-ended questions, and find out what’s going on in these peoples’ lives.

This is something that all physicians at all training levels should do. It’s an important step that we all too often skip in the pursuit of ‘efficiency’. We don’t really know a patient’s disease if we don’t know the patient.

Find out more about the AAMC’s Hot Spotting initiative and get involved.

[via Wing of Zock]

Why it’s the best time to be a healthcare entrepreneur | Rock Health →

Interesting interview with Zen Chu, the founder of HackingMedicine at MIT, about the digital health startup landscape. His reasons for why it’s the most exciting time to be a healthcare entrepreneur are at the bottom. I hope his third reason—“Large entrenched healthcare institutions are having a tough time adapting versus more agile startups”—is actually true, but I don’t know there is much evidence for that.