“This American Life” report on acetaminophen sensationalistic and inaccurate
September 26, 2013, 1:18 pm
The entire hour-long current episode of public radio’s This American Life is taken up by an investigation into risk of inadvertent accidental acetaminophen toxicity, carried out in association with the investigative public interest group ProPublica. The episode — titled “Use Only As Directed” — makes five major points, as summarized on the ProPublica site:
- About 150 Americans die a year by accidentally taking too much acetaminophen, the active ingredient in Tylenol, federal data from the CDC shows.
- Acetaminophen has a narrow safety margin — the dose that helps is close to the dose that can cause serious harm, according to the FDA.
- The FDA has long been aware of studies showing the risks of acetaminophen. So has the maker of Tylenol, McNeil Consumer HealthCare, a division of Johnson & Johnson.
- Over more than 30 years, the FDA has delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen. The agency began a comprehensive review to set safety rules fro acetaminophen in the 1970s, but still has not finished.
- McNeil, the maker of Tylenol, has taken steps to protect consumers. But over more than three decades the company has repeatedly opposed safety warnings, dosage restrictions and other measures meant to safeguard users of the drug.
The report argues that acetaminophen kills more Americans than another other over-the-counter drug, while admitting that existing data does not exist to allow an accurate estimate of the risks of alternative OTC analgesics such as ibuprofen. The reporter also states that it is “very easy to overdose on acetaminophen”, a claim that seems to me sensationalistic, alarmist, and inaccurate.
ProPublica has been accused in the past of reporting a “one-sided series of facts arrayed to support a point of view“, and I think this tendency is apparent here. Although “Use Only As Direct” contains interesting and important information, I found a number of major weaknesses in its argument:
- There is very little effort to put the actual risk of accidental acetaminophen overdose in perspective, given that 50 million Americans take the drug every week.
- There was almost no attempt to evaluate the risks of nonsteroidal drugs.
- There is no adequate reference to support the figure of 150 inadvertent acetaminophen deaths per year. I could not find where the FDA claims this figure.
- Even if the FDA has claimed the 150 deaths per year, this number is not reflected in recent data from the National Poison Data System.
- The report views the FDA in contradictory ways as it finds convenient: either as a huge inefficient bureaucracy that takes decades to finalize a simple warning label, or as an agency that can thoroughly and accurately evaluate hundreds of cases a year to determine if documented deaths are directly related to minimal acetaminophen overdose.
To be sure, inadvertent therapeutic acetaminophen overdose can be fatal — I am aware of one case in Chicago of a young patient who of acute liver failure died after taking about twice the recommended dose for several days after surgery. Clinicians should be aware of this possibility. But such cases are very rare.
ADDENDUM: (9/26/2013 9:47 pm CST): @ferrisjabr tweeted a link to a sidebar post in which @ProPublica explains how they used various databases to estimate the number of people seriously injured or killed each year by acetaminophen. The entire post is a exercise in reading comprehension, and after going through it several times I still have no idea about their methods. Apparently they combined the information in 3 flawed data sets: the FDA Adverse Events Reporting System, CDC’s Multiple Cause of Death database, and the American Association of Poison Control Centers National Poison Data System. In the end they conclude: “All we can say is just a fraction of people who take acetaminophen appear to suffer injuries or fatalities as a result”. It agree with that statement, but it is a far cry from the attention-grabbing claim that 150 Americans yearly die of inadvertent acetaminophen overdose.