Failure to Communicate

Quick: turn on the TV (no, streaming doesn't count!).  You won't have to wait too long before an ad for some prescription drug comes on.  Watch long enough and pretty soon you'll suspect that you have a variety of conditions that you may have never realized before and need to do something about immediately.  Fortunately for you, of course, the pharmaceutical industry has solutions for you.  It's all there in those ads.

Whether we really understand them or not is another question.

Direct-to-consumer (DTC) ads for prescription drugs are booming.  After a brief respite during the most recent recession, they're back up, with spending estimated at some $5.2b in 2015 (amazingly, the DTC ads are less than 20% of pharma's overall marketing budget, with the majority of that going to face-to-face "educational" efforts with physicians).

NATALIA BRONSHTEIN/STAT

DTC ads have been controversial since they were first allowed in the 1980's (although broadcast ads didn't really take off until 1997, due to more relaxed regulations).  Indeed, New Zealand is the only other country that allows them, and the AMA has called for a ban on them in the U.S.  There's a concern that, well, the ads work -- the pharmaceutical companies persuade consumers to want their drugs, whether or not they are more effective or cheaper than existing options.

New research from market intelligence firm InCrowd helps illustrate the problem.   They surveyed physicians about DTC ads, and found that they get three times as many questions about them as they did five years ago (although I was shocked that they report only six such questions a week).

Unfortunately, 65% say they do not believe their patients understood the information in the ads.  Only 13% of physicians thought that most of their patients could understand/interpret the ads, 43% thought that maybe at least some of them could, and the rest thought that few or none of their patients could.

Equally important, physicians do not believe the ads help.  In fact, almost half felt that they actually impair patients' understanding of their conditions or treatments:

Not surprisingly, 35% of the physicians would ban DTC ads entirely, while 31% want to at least provide additional patient information, and 17% call for simplifying the message.  

As evidence of the lack of understanding, a study in Annals of Family Practice found "substantial discordance between patient and physician evaluations of drug adherence and drug importance."  Nearly 20% of drugs considered important by physicians were not taken correctly by patients, and nearly half of that non-adherence was intentional. 

I guess the ads weren't quite enough.

This is serious stuff.  Harvard professor Donald Light points out that:

• New prescription drugs have a 1 in 5 chance of causing serious reactions even after they get FDA approval;
• Reactions from "properly" prescribed prescription drugs (e.g., for intended uses) cause some 1.9 million hospitalizations annually, with another 840,000 hospitalizations coming from other adverse drug reactions.  
• There are some 81 million adverse reactions suffered annually by the 170 million Americans taking prescription drugs.
• 128,000 people die annually die from reactions to prescription drugs, tying it for the 4th highest cause of death.
• At most only 15% of new drugs offer significant clinical advantages over existing drugs.

You don't really get any of that from those (fine print) side effect warnings, do you?

Let's be fair about the problem, though.  We can't put the blame on the pharmaceutical companies, at least not entirely.  We just don't understand our health care generally.  The Institute of Medicine estimates that nearly half of adults have trouble understanding what their doctor is telling them about their conditions and treatments.  Most patients discharged from the hospital don't understand their discharge instructions.  

The National Assessment of Adult Literacy found only 12% of us have "proficient" health literacy.  Low health literacy is associated with a host of health woes, including less use of preventive services, more chronic conditions, lower health status, and higher spending.  

No wonder we want to take action when we see those DTC ads, even if that may just compound our problem.

Part of the literacy problem is a societal one.  According to the Literacy Project Foundation, 50% of us can't read a book at a eighth grade level (which may help explain why 44% of adults have not read a book in the last year).  Forty-five million Americans are functionally illiterate and read below a 5th grade level.  Blame it on the schools, blame it on the parents, blame it on our culture, but wherever the blame lies, it makes communicating any complex issue difficult.

But much of the health literacy problem is health care specific.  Every industry has its own jargon, but few of them use the jargon with the consumers to whom they sell.   Names for drugs, conditions, treatments, even insurance features -- these are not ones that are easy for consumers to understand, remember, and make decisions about.  Health care is designed around health care professionals dealing with other health care professionals, not consumers, and its language reflects that.

In the unforgettable words of the sadistic warden in Cool Hand Luke, "What we have here is, failure to communicate.

Moreover, health care is notoriously imprecise -- try asking your doctor for the effectiveness statistics of a proposed treatment or prescription.  The statistics may not exist at all, may be contradicted by other statistics, or your physician may not know them or be able to communicate them to you.  It's hard to make good decisions with bad facts.

So, yes, DTC prescription drugs ads may be confusing, even misleading but, honestly, I have more trouble with how pharmaceutical drug companies try to influence physicians than with how they try to influence us.  

I'll own my bad decisions if I at least get unbiased advice, and with many aspects of health care I'm not always sure I am, given hidden financial incentives (e.g., prescription drug rebates, or payments by pharma/medical device companies to physicians) and the that's-how-we-do-it-here syndrome.  

We can do better.  Start with simpler language -- not talking to us like we're dumb but talking to us like it is important we actually understand -- and back it up with facts instead of marketing promises.  

That's an ad I would watch, or advice I would take.

Living in a Retro Health Care System

Living in the 21st century is cool, right?  We've got smartphones, ultra-thin tablets, the Internet, wearables, Uber, self-driving cars, virtual/augmented reality (VR/AR), drones, digital currency, and all the TV/movies/music you could want available for streaming anytime, anywhere.  It makes Back to the Future II's 2015 look drab by comparison (except maybe for the hoverboards!).   

So why does it seem like so many people are entranced with the 1980's?

Take, for example, the resurgence of vinyl.  Vinyl was replaced by cassettes in the 1980's, which were superseded by CDs in the 1990's, which fell to digital music in the 2000's.  But not so fast.  Vinyl is back, set to become a billion dollar industry (again).  

Sales of vinyl in the U.S. rose some 26% in 2016, and brought in more revenue than YouTube Musc, VEVO, SoundCloud, and Free Spotify combined.  It actually outsold digital music in the UK.  

There's even an annual Record Store Day to help celebrate vinyl's resurgence..  

It's not just vinyl.  People are falling in love with cassette tapes again.  Their sales rose 74% in 2016. although the number of units was still well short of vinyl or CDs.  Indie bands like them, as a cheap means of exposure, although major labels are exploiting them too, such as the release of the Guardians of the Glaxcy soundtrack cassette (the movie featured a main character toting around a beloved mix tape on his Walkman -- I kid you not -- as he battles evildoers throughout the universe).  

There's a Cassette Store Day too.  

People are even inventing new ways to listen to old formats.  The Verge reports on Love, "the first intelligent turntable," which is supposed to bridge old-tech with new tech, as well as Rokblok.  

Retro isn't confined to music.  One of the hottest Christmas presents was the Nintendo NES Classic, a modern, hand-held update of the original console, complete with 30 (mostly) vintage games.  Released in November 2016, it sold out almost immediately, and continues to have supply issues.  The president of Nintendo of America told Wired that they had assumed it would appeal to 30 to 40 year-olds who had played it as children, but its appeal proved much broader (some see intentional reasons behind the scarcity, but that's another story).      

Hey, we've got the Today show doing a 1970 retro show, the NFL going crazy with throwback uniforms, and the predicted reemergence of flip phones.  People even want retro computers, for gaming and for pure nostalgia.  And if Snap's Spectacles aren't intended as a cool mixture of retro and modern, I don't know what is.  

If any industry would keep its eye relentlessly on the future, you might expect it would be health care.  Better understanding of causes of diseases and underlying risk factors, more and better treatment options, slick new technology like wearables and nanotechnology.  Few of us would want to go back to what health care was like in the 1980's, and none of us would accept the health care of the 1950's (except maybe those house calls).  

No, in health care we expect the kind of futuristic -- or, at least, modern -- experience that tech-based start-ups like Oscar Health, Zoom Health, and the newest of all, Forward are promising.  They all want to offer "Apple Store" experience for health care (although, I don't know about you, but I usually end up waiting a lot in Apple Stores).  

If health care went retro, why, we'd usually make appointments to see our doctors in their offices instead of seeing them on-demand 24/7 (as two-thirds of us say we want), wait long periods in their bland waiting rooms, fill out lots of paperwork, have our white-coated doctor listen to us with their stethoscope, have lots of unnecessary or even harmful tests and procedures, even have our information sent by fax.  No one would want to go back to all that.

Oh, wait -- that is our health care system, for the most part.  It hasn't gone retro because we haven't yet moved past retro.  

Get this: fax machines remain the predominant form of communication in health care, with fax volume hitting new records.  That's not retro, that is insanity.  

Get this: physicians hate their EHRs so much that they are cited as a leading reason for physician burnout, and in their frustration with them physicians are turning to medical scribes to do the inputting.  

Get this: after seeing a consumer revolt in the 1990's against managed care's capitation, small provider networks, and restrictive medical management, they're all back in vogue, in one form or another.

I get retro.  I'm a Baby Boomer, after all, and very partial to the music, movies, television shows, cars, and other cultural aspects of the era in which I grew up.  We all are nostalgic about things from our formative years.   

But I do not want to get care in a retro health care system.  

EHRs are a perfect example of how we took something that should revolutionize health care, and turned it into something that not only no one is happy with but that many feel often impedes care, to the point some want to go back to paper records.  That's not retro, that's just stupid.  We didn't do the wrong thing with EHRs, we just are doing it wrong.

As I've written before, we should be thinking big and bold about how we want our health care system to work in the 21st century.  We should be setting tough goals for how effectively it works for us -- and expecting to achieve them.  We should be looking forward, not backward.

We have all the technology we need to make our health care experience, well, if not like magic, then certainly more like a 21st century health care should seem.  Let's get there first -- then maybe we can think about how we can do some cute retro to it.  

A Little Knowledge Could Be a Dangerous Thing

One day soon, we'll have real-time or near real-time information about our health.  Not just how we are at the moment but also whether and for what we are at-risk.  I'm fairly certain about this.

I'm less certain that this will be necessarily a good thing.

Michael Snyder and wearables (Steve Fisch, Stanford.edu)

The topic has received a lot of press recently due to a study by Stanford researchers (Synder, et. al) in PLOS Biology, which concluded that:

these results indicate that the information provided by wearable sensors is physiologically meaningful and actionable. Wearable sensors are likely to play an important role in managing health.

The study collected nearly 2 billion measurements (!) on 60 participants, who wore up to 7 tracking devices.  It focused especially on identifying early signs of Lyme disease and inflammation, and risk for Type 2 diabetes, but the authors expect that its implications will go much further.

Dr. Snyder told Scientific American: "Too much of the time we spend time measuring people when they’re sick.  What we really want to understand is what does it mean to define a healthy state, then quickly identify deviations from that state."  The trouble will be that we won't always know what those deviations mean to our health.  It will take a long time to figure out what our baseline is, and when which deviation mean what.

Dr. Snyder further noted, "We have more sensors on our cars than we have on human beings," a situation he believes soon will change, as the current wave of mainly activity trackers evolve to more directly track health measures.

The reference to sensors in cars is valid.  A Reuters article profiled how insurers are betting big on sensors.  Thirty percent of North American auto insurers are using sensors in cars to track driving behavior of their insureds in order to more accurately price their policies, and this is expected to grow to 70% by 2020.  Health care and health insurance will quickly follow.
 
Tracking isn't just limited to wearables.  A new urine test can determine within five minutes how healthy your diet is, and an MIT-backed start-up is developing a "smart toilet device" that can measure, in its first iteration, glucose and hydration levels.

A new breathalyzer claims to be able to diagnosis 17 diseases with one breath, including several types of cancer and kidney disease.  The researchers hope to incorporate the technology into smartphones.

University of Cambridge

That would just add to the ever-growing capabilities of smartphones.  Just within the past few weeks there have been announcements about them tracking heartbeats, diagnosing malaria, diagnosing and managing respiratory diseases, identifying genetic conditions, even sequencing DNA.  

There seem to be no foreseeable limit on what we will be able to track and even diagnose with the various ubiquitous technologies that are being developed.  We'll need AI to sift through all the data that will be generated about us, and to synthesize it into actionable information.  If we think EHR alert fatigue is an issue now, just imagine what it will be like when we have billions or trillions more data on our health, and more of that information is directed towards us, not just to our physicians.

We just may not want to believe everything they tell us.

For example, a new study found that a third of patients who had been diagnosed by a physician as having asthma did not, in fact, have it.  The lead author diplomatically cautioned that: "It's impossible to say how many of these patients were originally misdiagnosed with asthma, and how many have asthma that is no longer active," but it is sobering that the "gold standard" of a physician diagnosis can be that fallible.  Why then should we believe a wearable or smartphone?

Of course, one could argue that wearables or other sensors would have picked up the diagnosis sooner and/or more definitively, and could better have determined when it was no longer active.

The problem is that a lot of what is considered the state-of-the-art in medical beliefs is subject to change.  Aaron Carroll recently urged that we view such beliefs with a "healthy skepticism."  He detailed several examples of where what we "knew" to be true turned out to be, well, not so much.

As he pointed out, "Sometimes it’s hard to separate what’s truly a medical certainty from what is merely solid scientific conjecture."  Sometimes even those certainties turn out to be not quite so certain, and sometimes "solid scientific conjectures" prove neither solid nor scientific (e.g., the appendix is important after all).

All this is going to make it hard for us to turn all that data we're going to be collecting into meaningful advice.

The Mayo Clinic recently published The Promise and Perils of Precision Medicine. warning that so-called precision medicine, based on genetic testing, may not be all that precise.  It can lead to misdiagnosis, as well as unnecessary or even harmful treatment.  As the article concluded: "Although the technological advances in genetic sequencing have been exponential, our ability to interpret the results has not kept pace."

For "genetic sequencing," we could equally substitute a host of other new types of data.  For example, full body imaging was supposed to provide peace of mind, catching cancer and other issues sooner, but is more likely to result in unnecessary tests and procedures than in helping.

Our ability to be more precise does not mean we'll always be more accurate.

We will track more about our health.  The data will eventually tell us more about our health than we know now.  In the meantime, though, we're going to have to take what it says with a rather large grain of salt, rather than always rushing into action.  That will not be easy.

If tracking can help teach us to listen better to our body and to take appropriate action only when necessary, that's great.  If we end up relying on it to manage our health, though, then we've taken one more step away from our health, and from ourselves.

What I hope most is that all that data are training wheels rather than crutches.

At Least I'm Virtually Healthy

Virtual reality (VR) is hot.  It was one of the headliners at this year's CES (as it was at last year's...).  One report predicted that VR "will change everyday human experience in the coming decade," just as smartphones have in the past decade.   We're not just talking about much, much more immersive games, although that industry has been an early adopter.  Every industry is going to have to figure out how to best make use of it (and its cousin, augmented reality).

thealmostdone.com

Including health care.

What interests me most is whether VR proves to be a path towards improving our health, or if it will end up making us care even less about it.
VR is already making in-roads in health care.  One of the ways that VR is being used is to help people manage pain, whether that is for people undergoing painful procedures, people with chronic pain such as amputees' "phantom limb" pain, even women in childbirth.

The theory is that the brain can only absorb so much information at a time, and the VR experience can essentially crowd out the information stream that is carrying the pain signals.  You are still hurt, your body is still sending out pain signals, but, if the VR is done right, those pain signals are just getting lower priority.  Our brain would rather be in VR.

VR has also been proposed as a powerful tool in addressing a variety of mental health issues, including stress, anxiety disorders, or PTSD.  As with pain relief, some of the traditional alternatives include a variety of pharmaceutical remedies, some of which can carry risks of addiction, so VR can be a boon.

People are using VR for their health too, not just their health care.  Many people find exercise boring, especially extended sessions on treadmills, exercise bikes, or ellipticals.  For several years, many gyms have allowed users to pretend they were elsewhere while they exercised, tying activity on the exercise machines to images of more scenic locales playing out on flat screen TVs in front of them.

VR takes this to the next level.  Instead of essentially watching images on television, the VR is almost as if you are actually there.  VirZoom, for example, claims to straddle esports and exercise, as its exercise bike connects to a number of leading VR headsets.  Users can compete with other players as they work out.  Fitbit has already partnered with them.  

There are no shortage of other entrants trying to make VR part of fitness efforts.  For example, Blue Goji and Holofit have similar approaches to VirZoom, while Black Box VR offers a virtual gym, complete with virtual personal trainer.

The VR fitness program I want to see, though, would help remind people why they should try to get better health habits.  Many people have gotten used to their current health status, even if that status includes being overweight, poor cardiovascular systems, and weakening muscles.  We often slide from good health to fair health to poor health without fully realizing it, and that can be a pit that is hard to climb out of.  Watching TV is easy, junk food tastes good, while exercise is hard and eating better requires some discipline.  So many don't make the effort.

What if VR not other took us to other places, but also helped show us how we could feel?  Want to see how your body would look and feel like if you walked a mile a day and lost ten pounds?  If you ran 20 miles a week and lost 30 pounds?  Actually experiencing the fruits of your efforts before you undertook them, in order to better understand the effort/reward trade-offs, might serve as a powerful motivator for those who have had a hard time making those trade-offs.

VR could similarly help people make more informed decisions about proposed treatments that can have both positive and negative trade-offs, such as knee or hip replacements.

The better VR becomes, though, the more danger will be that, well, the VR version of us might be preferable to the "real" us.  People have gotten used to the concept of avatars in games, and invest a lot of emotional energy into what that avatar is and how they can "improve" it.  Our avatar in VR may increasingly be us, only a new-and-improved us.  Once robots have taken over our jobs and the government pays us a universal basic income (as Elton Musk and others have suggested will both happen), there may be less reason to be in reality and all-the-more reason to spend our time in VR.

We're already worried about the impact of excessive screen time on the health habits of teens, and that is without VR as a common option.  The trend towards how much time is spent per capita on playing games continues to steadily increase - again, without VR.  Think of the time we'll be soon spending in VR.

Once VR is ubiquitous, inexpensive, and as nearly lifelike as we can perceive -- all of which are in our near future -- why wouldn't we want to be in VR?  

It sounds a little like The Matrix, except that we might be voluntarily making the choice to live in VR instead of having it imposed upon us by our AI overlords.  We might like to think we're Neo, the hero of our own lives, but many of us might opt to be like Cypher, who found reality bland, difficult, and dangerous, and chose a virtual steak over helping his flesh-and-blood fellow humans.

We're barely scratching the surface of what VR is and what it can do.  VR headsets are clunky and expensive, and still have limited options for what they let us experience.  They're like early PCs or early smartphones.  Not many in 1987 imagined what their PCs would be able to do in 2017, and not many in 2007 saw all that smartphones of 2017 would offer. The gap between VR of today and VR of 2027 will be wider than that of the gap between the first iPhone and today's iPhone 7.  

Virtual reality is going to do wonderful, amazing things.  It will change how we play games, how we do business, how we socialize, how we get health care -- in short, how we live our lives.  The question is, will it help us live better, more productive lives -- or will it become our lives?  


 

2017 Prediction: Some "Oops" Ahead

Predictions for 2017 are everywhere this time of year, and it is no wonder.  There are so many technological advances, in health care and elsewhere, and a seemingly endless appetite for them.  We all want the latest and greatest gadgets, we all want the most modern treatments, we all have come to increasingly rely on technology, and we all -- mostly -- see an even brighter technological future ahead.

Here's my meta-prediction: some of the predicted advances won't pan out, some will delight us -- and all will end up surprising us, for better or for worse.  Like Father Time and entropy, the law of unintended consequences is ultimately undefeated.

What started me thinking about this was an article in Slate, "Self Driving Cars Will Make Organ Shortages Worse."  Self-driving cars are a hot area these days, with auto makers trying to prepare for a future where car ownership lessens in importance and driving services like Uber and Lyft trying to make that happen.

One of the key appeals of self-driving cars is that, well, humans generally are pretty crummy drivers, being prone to distractions, falling asleep, driving while impaired, and so on.  Without us, the reasoning goes, there should be a lot fewer accidents and deaths.

That sounds like good news (unless you are in the auto repair business), but, as the Slate article points out, 1 in 5 organ donations come from of victims of car accidents.  Stop us from killing ourselves or others on the road, and suddenly a huge problem crops up for those roughly 120,000 people on the organ transplant waiting list.

Talk about unintended consequences.

Well, you might say, that's a good problem to have, and technology will fix it too.  After all, soon we'll have artificial organs, even 3D printing them.  As big a fan of bionics and 3D as I am, though, somehow I suspect there are some shoes yet to drop with them as well.

An even more worrisome example is gene editing.  In a recent post, I likened its potential to magic.  Snip a few undesired genes out, substitute some other ones, and we can potentially cure or prevent some important health problems.

Even more startling, the technology can be used to ensure that such edits persist and spread in subsequent generations, potentially changing entire species.  This process of changing entire future generations is called "gene drive."

Magic indeed.

Michael Specter did a deep dive on the topic in The New Yorker.  He profiled the work that Kevin Esvelt is doing at MIT.  One project that Dr. Esvelt is working on is getting rid of Lyme disease by ensuring that the disease's repository -- mice -- can no longer carry it, so that ticks biting them don't get inflected and thus can't infect people.

The same could be done with say, mosquitoes and the malaria they can carry.

The potential dangers are becoming recognized.  The director of national intelligence listed gene drive as a potential weapon of mass destruction, a concern echoed by the National Academy of Science.  As Dr. Esvelt said. "My greatest fear is that something terrible will happen before something wonderful happens. It keeps me up at night more than I would like to admit."

Worse yet, the terrible things may not even be deliberate.  As another researcher warned Mr. Specter:

But gene drives affect entire communities, not single individuals. And it can be almost impossible to predict the dynamics of any ecosystem, because it is not simply additive. That is exactly why gene drives are so scary.

The real danger may be that an overwhelming need in a local area -- e.g., Ebola, AIDS, malaria -- may cause local officials to take chances.  As an African public health official told Mr. Specter, "Principles matter to us as much as they do to Americans. But we have been dying for a long time, and you cannot respond to death with principles."

Applying gene edits in such a situation might solve immediate concerns, but with broader implications.  Dr. Esvelt put it bluntly: "A release anywhere could be a release everywhere."

Because CRISPR is making the technology much cheaper and much more accessible, how it  is used becomes especially important.  We don't really want someone in their garage lab inadvertently wiping out all cats, for example.  As Dr. Esvelt stressed, "The only way to conduct an experiment that could wipe an entire species from the Earth is with complete transparency,"

That may be a big ask; we're not even completely transparent about adverse outcomes of current types of medical treatments.

Mr. Specter himself appears to be cautiously optimistic:

We have engineered the world around us since the beginning of humanity. The real question is not whether we will continue to alter nature for our purposes but how we will do so. Using a mixture of breeding techniques, we have transformed crops, created countless breeds of animals, and converted millions of wooded acres into farmland. Gene drives are different; one insect could affect the future of our species. But it is a difference of power, not of kind.

Pew Research Center did a study on using biomedical technologies to enhance human abilities, and found that we are decidedly skeptical.  About two-thirds were worried about each of the three specific scenarios -- gene editing, brain implants, and synthetic blood -- but about three-fourths thought that the technologies would end up being used before they were fully tested or understood.

Ironically, respondents were most enthusiastic about gene editing, but only in regards to doing so to give babies a reduced disease risk -- not changing our entire population through a gene drive.

Technology change is going to happen.  It will inevitably change our culture and, to some extent, us.  We're not very good about not using technology once invented.  The question is how we prepare for it. Christopher Mims believes that "the art and science of futuring is fast becoming a necessary skill."  It is less about predicting the future than preparing for a variety of futures

As Donald Rumsfeld infamously once said, there are known unknowns and unknown unknowns.  We think more about the former than the latter, but that needs to change.   

We should be spending as much time thinking about the potential consequences -- good and bad -- of cool new technologies as we do being excited about how cool they seem.