Acceptable risk

A number of years ago I was on a "Governor's panel" that was asked to look at environmental issues for the State and come up with some prioritization of risks in this area.  One of the first risks that made the "needs attention" list was the risks to the State from pesticides.   After several days of meetings, no one had added "pests" to the list.  In Boulder, Colorado, there were, over the years, many meetings of various groups discussing the risks to the enviroment from activities in Boulder.  There were few, if any, discussions of risks to Boulder from the environment until a woman out jogging was caught by a mountain lion and killed.  Then there were meetings to argue about whose fault it really was, the woman's or the lion's.  Northern California was so committed to not posing a human risk to the environment that they allowed the mountain lion risk to humans to grow unchecked.

The book Acceptable Risk, though written a couple of decades ago, is still one of the best references on how to think clearly about competing risks.  Psychological research has shown that people in general find it uncomfortable to deal with tradeoffs between competing risks -- it's a little too unmanageable.  It is more calming to think that risk comes from only one direction and we can have as much or as little of it as we chose just by spending money.  Unfortunately, this is virtually never the real case, and when we act as though it is, we make decisions that don't align with the reality we are trying to manage.

The current concerns about medical risks focus almost entirely on drugs risks and how to control them.  There is little discussion in these articles about the risks of from the medical conditions that might warrant taking one of these drugs.  Our daughter was once offered a drug that could scar her kidneys, we were told.  We opted to have her take the drug because she had acquired an e coli infection and had a temperature approaching 105 degrees F and because of allergies to other antibiotics, this was the only drug she could take that was powerful enough to hit the infection.  We had been forced to go to a university medical center specialist to find even this drug.

Making choices between competing risks is made difficult -- and distressing -- in a number of ways:  it is unsettling to accept the fact that every course of action that is available poses a risk to life and limb; it is disturbing when technical experts can't agree with each other, let alone with public advocacy groups; it is worrisome to learn that government agencies spend far more protecting us from carcinogens in our food than in our drinking water or the air we breath.  So agencies like the FDA are criticized for allowing the public to be exposed to undue risk from drugs and at the same time criticized for stifling innovation and imposing delays on needed drugs that are too long and expensive -- let's go to Canada or Mexico for drugs, some say.

Society has organized building codes, regulatory agencies, acts of Congress like the Toxic Substances Control Act, labor unions, Underwriter's Laboratory, inspectors, agents,  and more to control the risks to which we are exposed.  And the sense of the public is that this should be adequate:  there shouldn't be any risk now.  The idea that getting rid of one risk typically creates another is very unattractive; it's discomfiting to find out that while we may get to have input on what the tradeoff-level is, there's no option marked "no risk at all."

Today's Wall Street Journal features an article on "What Makes a Drug Too Risky?"  (subscription):

The flood of reports in recent months over the risks associated with a variety of widely used medicines has spotlighted the issue of drug safety with as much intensity as at any time since furor over birth defects and the morning-sickness pill Thalidomide. That episode in Britain in the 1960s sparked an overhaul of drug evaluation and gave rise to the modern Food and Drug Administration in the U.S.

How great are the risks posed by the drugs attracting the most attention?  Vioxx has been removed from the marketplace by Merck because it posed heart-attack risks; Prozac may cause people to commit suicide.

Merck pulled Vioxx after a study found an extra 7.5 heart attacks and strokes per thousand patients on the drug for at least 18 months compared with a placebo. GlaxoSmithKline PLC's antidepressant Paxil raised concern based in part on an analysis of nine studies showing 3.4% of patients had side effects "possibly related to suicidal behavior" compared with 1.1% on placebo.

Despite the small numbers, medical science can't definitively rule anybody in or out of danger.

Doctors often encourage patients with heart problems to take a full-strength aspirin everyday to help protect against a stroke -- the aspirin "demagnetizes" platelets in the blood so they don't clump together.  That sounds good; the statistical evidence is that apirin prevents one stroke in about every 120.  It also causes stomach problems for many people. 

No one gets Vioxx now because in one study among people who took the drug for 18 months  there was an additional 0.0075 chance of a heart attack.  Would you trade the risks of chronic pain for a 0.0075 risk reduction in your chances of a stroke over the next couple of years?  Do you drive when you're tired?  Stay up late and use caffeine to to keep you awake (and raise your blood pressure and chances of a heart attack)?  These are risky behaviors, but there is the competing risk of not doing well  in your job and not getting promoted.  Or getting fired and losing your health insurance -- maybe you would rather have health problems and coverage than lots of sleep and no insurance.

In response to public concerns that there are undue risks posed by drugs, action is being taken:

Amid rising consumer concerns about the risks of prescription drugs, the Bush administration said it intends to step up the Food and Drug Administration's role in monitoring the safety of medications already on the market.

At the center of the FDA effort is the creation of a new Drug Safety Oversight Board to review safety issues that arise in drugs already approved by the agency.

That should solve the risk-tradeoff problem:  another agency and board of experts.  There will be longer delays in approval of drugs we want now, higher costs for drugs so fewer people can afford them, major health benefits lost because of tiny side effects -- all topics that have created government criticism in the past.  The government's response will be to appoint another task force or board or agency.

In the end, there will be the same dilemma:  a set of alternatives, each of which poses serious risk.  And we'll ask the government to "take action" and they will appoint another panel or agency to eliminate risk created by a previous government agency.

P.S.  Our daughter made it past the e coli infection thanks to an extremely risky drug -- without it, it is doubtful she would be with us today.  We're thankful the FDA allowed us to make this decision on which risk we preferred rather than deciding that they would eliminate drug risk entirely for us.