Government Safety Regulations can cause net deaths

There is a tradeoff between safety and cost, the latter measured both in dollars and foregone opportunities.  The more safety, the higher the dollar cost and the more valuable the foregone opportunities.  Moreover, there is no way of achieving complete safety.

Balancing safety, cost, and the value of foregone opportunities can be thought of as an optimization problem (not that we know the optimum).  The more constraints added in the form of Government Safety Regulations (GSR) that reflect a focus on only part of the problem, the less likely the optimum is a feasible solution.

The problem with GSRs is that tradeoffs seldom are taken into proper account.  GSRs too often reflect a focus on reducing the probability of obvious adverse events without considering adequately their less obvious adverse consequences.  There is a reason for this – most voters, media talking heads, and politicians are aware of the former and unaware or less aware of the latter.  Therefore, they clamor for GSRs protecting them from the former – and Government obliges.  The result is a high probability that GSRs are too restrictive – in the sense that an informed populace would choose less restrictive GSRs.  A reasonable assumption is that GSRs are too restrictive and often cost lives by failing to consider all aspects of safety.

Example: Drugs

Drug safety is paramount in most people’s minds.  The last thing Politicians and Bureaucrats want is an angry public reaction to a drug killing people.  Consequently, GSRs focus on assuring safety.  But the only way safety can be assured is by not using drugs.  GSRs try to accomplish safety by requiring a huge amount of expensive and time-consuming testing and approving only “safe” drugs.  This assures a large measure of safety, but at the cost of unnecessarily expensive drugs that reach the market long after they could have, the failure to develop drugs with possible serious side-effects for diseases where no effective drugs currently exist, and the failure to develop drugs that would have been effective for serious rare diseases where the potential market cannot justify the expense of going through the approval process.  Safety is necessarily achieved at the cost of excess deaths – a tradeoff that is largely ignored in the analysis leading to the GSRs.

The potential excess deaths can be large.  To illustrate, suppose a drug is delayed one year and that it can reduce the death rate from a serious disease by 50% from 20% to 10% relative to existing drugs.  If the disease’s incidence in the population is 0.01%, then about 30,000 people in the US will contract it annually.  Of these, 6,000 people will die if the new drug is not available and 3,000 will die if it is available.  Excess deaths are 3,000 for each year delayed.  But this is only part of the story, because subsequent even newer drugs each will be delayed, too.  Thus, the total of excess deaths over time far exceeds 3,000 with a drug approval process that takes one year longer than the optimum.

It is about time that sick people are allowed to try promising drugs before they complete the approval process.  It should be up to the sick people to determine the risks they take, not the Government.