Conveying Information...

...or "Welcome to My Caveat Emptor World"!

          Imagine someone knocks on your door and when you open up, it is your neighbor and they start telling you all sorts of things in an intense tone:

“I noticed you have a big crack in your sidewalk – someone might trip on that.  Also I see that downspout is loose and it might fall and hit someone.  I saw a couple of termites coming out from that post there holding up the porch – probably should get that checked out.  I found this nail in your driveway.  I noticed that there are flames shooting out of your upstairs window.  There are some frayed cable wires by the side of your house – some animal is chewing on them.  Oh, and part of the fencing around the base of your deck is broken – animals love to get underneath and take up residence there…”

…and while he is still talking, another neighbor rushes up and says:

“There are flames shooting out of your upstairs window!”

          Now I ask you – which neighbor gave you the most information?

          Both neighbors told you that there were flames shooting out of your upstairs window.  But the first neighbor told you a lot more than that.  So isn’t it obvious that the first neighbor gave you the most information?

          Well, not to me.  To me it is obvious that the second neighbor gave the most information.  Even assuming that everything the first neighbor said was true, I say that the additional information clouds the important issue and therefore it borders on dis-information.  More information is not always more information.

          What’s the point?  The point is that our society is operating under the full assumption and belief that the first neighbor is clearly the better neighbor and is clearly providing more information.  And I don’t buy it one bit.

          I’ll just pick on one example, but there are many many other examples.  Specifically:  commercials for a new drug.  The FDA requires those commercials to list all of the possible side-effects of the drug.  Great idea.  Make sure the public knows about those.  For example, how about this one[1]:

“…Invokana can cause important side effects, including dehydration, which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up. Other side effects may include kidney problems, genital yeast infections, urinary tract infections, changes in urination, high potassium in the blood, or increases in cholesterol. Do not take Invokana if you have severe kidney problems, or are on dialysis. Stop taking and call your doctor right away, if you experience symptoms, such as rash, swelling, or difficulty breathing or swallowing, Tell your doctor about any medical conditions, medications you are taking, and if you have kidney or liver problems. Using Invokana with a sulfonylurea or insulin may increase risk of low blood sugar. ...”

          I know that many people consider drug companies evil and just out to get your money and that they would (and do) try to hide all of the side-effects of their drugs in order to make a profit.  Of course they do – they are a for-profit company.  Drugs have side-effects.  You should expect that.  As a result, you probably do have to require drug companies to present all of their side-effects or they will have a tendency not to do it.  I am not opposed to that.  What I am opposed to is being required to list every side-effect, essentially regardless of severity and frequency, in a big monologue laundry list. 

          What I would rather see is that the commercials must list the three (maximum!) most common or most severe side-effects.  Probably, in general, this would end up being an agreed-upon combination of frequency and severity.  As a default, I would say that in most cases we would want to know the most frequent side-effect (probably dizziness in the case of Invokana[2]) and the two most severe side-effects (I’m not sure what that would be in the case of Invokana – maybe the fact that you shouldn’t take it if you have kidney problems or are on dialysis).  In most cases, you would need to parse out the data a bit first to make a determination of what should be listed.  For example, if a study subject dies after taking a drug, that is obviously a severe side-effect.  But if a single death occurred in a study of 1000 subjects, and the death had an unknown relation to the drug, then that one might fall off the list in favor of something more common but somewhat less severe.  For example, if that same drug resulted in osteoporosis such that 5% of the study subjects had fractures within one year of being on the drug, that would certainly rise to the top of the list!  What I am suggesting is not simple to implement because it does take a judgement call.  I believe, however, that it would provide more information than an unranked laundry list.  Even on the package inserts, I would want to see those top three items in bold, larger font, and all the rest of the laundry list in smaller font (or just direct the super curious to a website where they can read the whole study results). 

          I think this approach would allow consumers to make a better comparison about the severity of side-effects of different drugs.  If drug A has a top three of:  1) light-headedness, 2) urinary tract infections, and 3) don’t take it if you have kidney problems; and drug B has a top three of:  1) tachycardia, 2) heart attack, 3) death…well, doesn’t that tell you something very important right away?

          I know that there are those who argue that such an approach is hiding a bunch of other side-effects and “what if I get one that isn’t listed?”  Well, that is certain to happen – rarely.  If you take a drug, any drug, you just have to know that you might be the one in one thousand who gets the odd, unusual, and possibly severe side-effect.  Or maybe you are the one in one thousand who gets a side-effect that no one encountered in the clinical trial and so it was unknown anyway.  In my opinion, you just have to know there is an underlying risk going into it, and accept that risk (or live in a bubble).

          Going back to my original illustration, let’s just say that one in ten-thousand side-walk cracks indicate an impending sinkhole, of which 1% of those sinkholes will be big enough to swallow your whole house.  Thus it may be – just possibly – that your sidewalk crack indicates a bigger impending doom than the fact that there are flames coming out of your upstairs window.  To me, the trade-off is worth the risk in this case.  If, by giving a laundry list of all the risks, you miss the one key risk that is most critical, most common, and most immediate, then that is a bad outcome.  For the one person who is about to be swallowed up in a sinkhole while his upstairs burns, well…he is having one really really bad day and there is nothing we can do about it.  Instead, I say, be like neighbor #2 and convey the critical information.  Better yet, bring your hose with you!

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[1] I don’t know anything about Invokana – I just picked this one randomly because I could find the text of their commercial online easily.

[2] I didn’t go back and check the data here about Invokana – I’m just guessing for the sake of example here.

Drugs and Devices

          This entry is about my thoughts regarding medical treatment using drugs compared to medical treatment using devices (generally speaking, implanted devices).  First, some personal background so that you can see my biases.  I work in the implantable medical device field, so naturally I am biased towards them.  I have seen firsthand the impact that they can have – not only for the implant recipients I see at work, but also in my own family.  However, I personally do not have a device implanted inside me (yet!) – unless you count the pencil lead lodged in my thigh from an accident in second grade; or the small hunk of metal in my thumb from changing a tire in my rusted out Galaxy 500.  I have had electrodes implanted in my forearm and hand for various testing purposes, but they were just temporary.  I don’t like surgery – but who does?  Also, I’ve never been on any regular medication for anything other than the occasional antibiotic and various NSAIDS and cold medications.  So - that's my background.

          In general, devices are the option of last resort in medical treatment today.  By that I mean that the practice of medicine is designed to try to treat any disease with medications first, generally proceeding from the “least intense” to the “most intense” medication.  Along with treatment via medication, there will also be treatment via non-invasive therapies.  For example, if you have back pain, it will first be treated with some therapy (exercises and so on) and NSAIDS.  As it gets more intense, you will progress to more intense painkillers.  Eventually you may be prescribed an opiate.  If you fail all of those, then you might get back surgery.  And if you fail that, you might get an implanted device called a “spinal cord stimulator” (SCS) device for pain relief.  Of course the treatment path is not always linear, and it varies from specialty to specialty, but in essentially any case, the device is the last resort.

          Because of the field of research I am in, I frequently have the opportunity to talk to disabled individuals about their interest in having a device implanted in them to improve their function and independence.  Occasionally I come across someone who says that they never want to have a device implanted inside them.  At first I thought that it was because they didn’t want to go through surgery again, which is fully understandable.  But no, they are often willing to undergo surgery if it would help, just not have a device inside of them.  I found that to be rather interesting.  I hope they never need a pacemaker!

          To me, it comes down to this:  we are more afraid of what we can see than what we can’t see.  If you take an x-ray of someone who has a device implanted in their body, you’ll see the device plain as day.  It is obviously “unnatural” and that is rather unnerving to all of us.  If we see an x-ray somewhere that shows a lot of “hardware” inside of a person, we’re likely to be thankful that is not our x-ray.

          By contrast, if you take an x-ray of someone who is fully addicted to pain-killers, you won’t see anything different.  Even if you take an MRI, you won’t see anything different.  In fact, even if you take their brain, dissect it apart, and examine the individual neurons, you still might not see the addiction itself.  It is, for all intents and purposes, invisible to us.  For most of us, the effect of most drugs on our body is never immediately visible.  And so…it seems safe.  Even if we drink a bit of a poison like arsenic, there may be no immediate effect.  But it has effectively invaded every cell of our body.  We can’t get rid of it.

          The reality is that drugs are frequently more dangerous to us than any device.  Are there any drugs that do not have side-effects?  Often, a second drug is added to reverse the side-effects of the first drug, and so on.  We accept the side-effects because it seems like an acceptable trade-off if we get the relief we are seeking from our primary symptoms.  The problem is that some of the most serious side-effects are very slow developing.  Drugs that increase the likelihood of getting cancer, or damage our liver, are usually very slow acting and those more serious side-effects do not become apparent until years, even decades, later.  By then it is too late.  In those cases, you can’t reverse or even treat the effects.  If you stop taking the drug, you may still be left with its side-effects – sometimes for the rest of your life.

          To be sure, there are some potential “side-effects” of devices.  The most common disadvantage with any implanted device is the risk of infection.  On rare occasions devices move inside the body, or some part breaks and it no longer works.  But, the point is, these are fixable problems because, in the worst case, the device can be removed to resolve the problem.  The thing that seems the scariest to us – the fact that we can see it on an x-ray – also makes it inherently safer.  If we can see it, we can remove it and get rid of it.  In most cases a device can be removed without any further consequences.

          Another apparent disadvantage of devices is their initial expense.  Because they involve surgery, and they are often very expensive themselves, the whole cost of getting a device can be quite high.  Insurance companies are reluctant to pay that up-front cost.  They would rather pay monthly for drugs you have to take daily than to pay for the one-time cost of implanting a device.  There is an aspect of human nature that would rather spend $5/day every day for the rest of their life than to pay $5,000 now and be done with it.  Often the math clearly comes out in the favor of the device, particularly if it is more effective than the drug, but that is usually ignored.  In that sense, we seem to prefer the “death by a thousand cuts”, though maybe that is a poor idiom to use in this case!

          The point is that since devices are nearly always relegated to the “last resort”, it means we all have to first live through the side effects of drugs before a device will be considered for treatment.  However, there are certain situations where that leads to two major disadvantages.  First, we are stuck with the side-effects of the drug, and some of those side-effects are difficult, if not impossible, to reverse.  Second, by the time a device is utilized for treatment, the disease has progressed to the point where it is much more difficult to treat by any means.  Thus a device, which might have provided relief at an earlier stage, can no longer provide any relief.  There is even some evidence that if devices were used at an earlier stage, they might halt or even reverse the progression of the disease.

          Medical devices do have to be made safer, smaller, less-invasive and more effective.  They are certainly not always the answer.  But there are cases where progression to treatment with a device is better for the patient and is more cost-effective, than continued treatment with drugs.  For example, our current health care system is set up to keep treating chronic pain with opiates until the person is potentially addicted, before considering treatment with a device like a spinal cord stimulator.  The device is not always the solution, but there is evidence that the device would be more effective if it were used earlier, and it does not have near the negative personal, social, and financial consequences that opiate addiction has. 

My point is that medical devices should be given a fair consideration in the treatment of various diseases and disabilities, and not always relegated to the “last resort.”  This is a significant change in thinking.  First, the practice of medicine will have to be convinced of the potential of devices to be more than a last resort in certain situations.  Second, the reimbursement structure will have to change to reflect this difference in thinking.  And, finally, the perception of devices by the general public as being more invasive than drugs will have to be adjusted.  Each one of these steps is a major undertaking.  It will certainly not happen overnight and probably not in my lifetime.  But I do think that eventually the general perception will change on this issue.