...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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