Saturday, December 19, 2015

Why Should I?

Giving Advice

Governments, parents, and other authorities often give the subjects under their care advice about what to do, ostensibly for the betterment of their own welfare and that of others around them.  Two examples from the realm of traffic safety will serve to illustrate this phenomenon.  First, pedestrians are often told to look both ways before crossing the street.  Second, speed limits are usually in place on any given road that prohibit the speed at which vehicles may be driven.  The obvious difference between these two examples is that while compliance with the directive to pedestrians is voluntary (at least on the part of the government), the second is compulsory.  If you go above the speed limit, then the government is legally entitled to collect money from you, and perhaps take your license way.  There are no such consequences to pedestrians who only look one way instead of two.

Similar instances of government advice are to be found in food safety.  On the compulsory side of things, the government may legally limit which chemicals are added to food, and how much can be added when they are approved for use at all.  Food manufacturers who fail to comply with that government advice can have their products found to be “adulterated” and seized.  On the other hand, the government has far less authority to regulate chemicals that are aren’t deliberately added.  The practical reason for that is that it often isn’t possible to separate the chemical from the food.  As the main topic for this discussion, all fish contain methylmercury in varying amounts, which is known to be neurotoxic.  But, fish can also be an important source of many nutrients.   Consequently, many state public health departments and the federal government have issued advisories that direct expectant mothers to restrict how much and which fish they consume.  Compliance on the part of consumers is entirely voluntary.

Considering the Science

Generally speaking, authorities don’t tell people what to do without a reason.  For example, transportation departments keep statistics on accident rates, so they have a pretty good idea about how the frequency and severity of the accidents that occur will be with different speed limits.  They also have higher speed limits on roads used for commuting and intercity travel, and therefore set lower limits on streets that are likely to have pedestrians.  That doesn’t mean, of course, that everyone agrees with it.  People may disagree with the facts, or the decision given the facts.  But, if the advice is legally enforceable, it doesn’t really matter whether you agree or not; the penalty for failing to comply or not it the same.   On the other hand, if the advice is just a suggestion or guideline then you are free to disagree as you like.  For example, if you think looking in just one direction on a one-way street is sufficient, then you may do so.

On the topic at hand, a group of 30 senators recently addressed a letter to the Food and Drug administration concerning the advice to be given to pregnant women regarding fish consumption.  The concluding paragraph is as follows:

One of the FDA’s core responsibilities is ensuring that consumers have access to accurate, actionable information about the agency’s scientific findings.  Prior to issuing final advice, we strongly encourage you to consider the science underpinning the advice, and also the manner in which information is relayed to the consumer.  While we are eager for the advice to be finalized, it is critical that the final advice reflect the latest science and be presented to consumers clearly so they can make the best possible decisions about the nutritional value of seafood during pregnancy.

It seems that the senators are giving the FDA advice about what advice to give.  This advice may not be compulsory, but it is “strongly encouraged”.  So, what is it the FDA is being advised to do?  The most prominent directive is that this group of senators expects the agency to put consumers in a position to make their own decision.  That will obviously require the agency to in addition to (or perhaps instead of) telling pregnant women how much and what fish to eat, consumers should be informed of what is likely to happen if they eat less or more than the suggested amount.  This is especially important since the advice is voluntary; some women may prefer to eat less fish while others may prefer to eat more.

The other directive is that the FDA should “consider the science”.  This may sound trite, but it really isn’t.  For one thing, it means that in addition to giving the reasons underlying the advice, the agency can’t just make those reasons up.  It also means that the agency needs to take a public position on what the risks and benefits of eating fish are, and be willing to defend those assertions before the scientific community.  For example, the risk benefit analysis mentioned in the letter qualifies in that regard (disclaimer: I was a primary author of that report).  If the agency is currently unwilling to stake its reputation on that report (disclaimer: I don’t work there anymore) then they should be able to present the alternative that they are currently willing to defend. 

Because We Say So

Regardless of what scientific position the agency takes, it is clear that there also value judgments that go into deciding how much fish to eat.  For example, the risk-benefit analysis on the FDA web site describes neurobehavioral risks and benefits associated with the consumption of various species of fish, and estimates an optimal amount of fish consumption for each.  But, translating those results into how much fish should be consumed isn’t exactly straightforward.  There are judgments to be made about how important it is to be optimal.  Does 1 IQ point really matter?  How about one tenth of an IQ point?    How will the many uncertainties associated with estimated effects that are largely too small to measure accurately be resolved? 

The agency can, of course, place a value on small uncertain changes in IQ and other measures of behavioral performance themselves.  In fact, making value judgments on behalf of the public is what regulatory agencies are generally in the habit of doing.  Furthermore, that is exactly what many consumers want.  But, for fish consumption advice, that tactic almost certainly isn’t going to suit everyone; especially those people who are otherwise disposed to eat more or less fish than the prescribed amount.   In particular, wrapping all the science and value judgments into a single arbitrary number (e.g. the EPA Reference Dose) that defines “safety” without conveying any information about what anticipated health consequences are won’t put consumers, or anyone else for that matter, in a position to make their own decision.

References




Official Post Soundtrack

Smiths, The (1984).  What Difference Does It Make?  In: The Smiths, Track 8

Post Notes

Thesis Post #52.  Part of the fish advice saga, and the first that is based on current events. Unlike the the more historical posts on the same topic, this one is basically an editorial.