Beneficence, the desire to do kind deeds, is the fundamental principle at the heart of medicine. Yet, one of the painful lessons medicine teaches is that good intentions don’t always lead to good outcomes. Occasionally, the result of good intentions is terrible tragedy. Two separate medical incidents reported recently, one involving the FDA and antidepressants, and the other involving UNICEF and contaminated drinking water, are painful reminders of that lesson.
In the past decade, several large population studies have demonstrated an association between certain antidepressants, and suicidal thinking and behavior in youths. Because patients who receive antidepressants have a higher risk of suicide than the general population, the studies were unable to establish conclusive causation attributed to the medications. The question remains - were suicides the result of the prescribed medicines or the underlying condition? The FDA, acting in good faith, elected to issue a requirement that a “black box” warning, advising of a potential suicide risk, be placed on antidepressants prescribed for youths and young adults.
A new study by researchers from the University of South Florida and University of Illinois suggests the black box warnings may have had the unintended consequence of placing more youths at risk of suicide. The researchers found the “black box” warnings resulted in a marked reduction in antidepressant prescribing for adolescents and adults. They demonstrated an increase in youth suicides associated with the temporal decline in the use of antidepressants, a finding they say also occurred in the Netherlands after a similar warning about the drugs was issued there.
One of the study authors, Hendricks Brown, said, “The overall effect of these newer antidepressants is very likely that they reduce suicide risk considerably. Overall, the new antidepressants provide a large protective benefit. If there is any group of people who are adversely affected by taking these antidepressants, it has to be a very small group.” Brown said health policy decisions are sometimes based on limited information and the FDA might have inadvertently placed more youth at risk by mandating the warnings. The FDA is now reviewing policy decisions in the light of these data and at some point may withdraw or revise its warning.
An even more tragic instance of unintended consequences was recently highlighted in Lancet. It involved what is believed to be the largest known case of mass poisoning in world history. In the early 1970’s the newly formed country of Bangladesh, formerly East Pakistan, was ravaged by a cyclone, famines and political unrest (Most of the world first found out about the plight of the suffering populace when Beatle George Harrison organized the Concert for Bangladesh, the first charity rock concert).
During this time, the only drinking water available to most Bangladeshis came from ponds and shallow pits contaminated by human and agricultural waste. Diarrhea, cholera and typhoid were rampant and annually killed thousands, especially children. Western relief organizations headed by UNICEF embarked on a large-scale program to help Bangladesh by drilling millions of shallow tube wells that provided drinking water by hand pump.
The tube well drilling program drastically reduced the spread of gastrointestinal diseases and cut child mortality in half. For this, it was hailed worldwide but what no one realized at the time was that the groundwater feeding many of those tube wells contained extremely high concentrations of arsenic. The naturally occurring arsenic, leached from rocks as the result of runoff from Himalayan snows, could not be detected when the wells were dug. Millions of the Bangladeshis have been poisoned with the highly toxic, carcinogenic chemical for three decades as a result of the wells drilled in the 1970s.
Programs are currently underway to test for arsenic and dig deeper wells that tap safe groundwater but Dr. Joseph Graziano, health professor at Columbia University explains, “Bangladesh’s drinking water is one of the world’s most hazardous because of the presence of arsenic. An estimated 40 million people, roughly 30 percent of the population, are currently exposed to poisonous levels of arsenic.”
As these cases indicate, medical decision-making is a balancing act of risk and benefit. Decisions come with hidden variables and unknown facts. Unfortunately, this means some risks are poorly perceived. The familiar adage “the road to hell is paved with good intentions” may be an overstatement but occasionally the signpost marked “good intentions” leads down a tragic path. The safe road turns out to be filled with danger.
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