ProPublica, This American Life and acetaminophen: $750,000 to state the obvious

ProPublica and This American Life, both which I love, are making some waves for a story highlighting the risks of taking too much acetaminophen (known as paracetamol in the UK). They found that “taken over several days, as little as 25 percent above the maximum dosage – or just two additional extra strength pills a day – has been reported to cause liver damage”.

In a more than 10,000 word piece, they say that over the past decade 1,500 people have died from accidental overdoses of the drug in the US. The story is very critical of “McNeil Consumer Healthcare, the unit of Johnson & Johnson that has built Tylenol [the brand name of the drug in the US] into a billion-dollar brand and the leader in acetaminophen sales”. The story claims that:

McNeil opposed even a modest government campaign to educate the public about acetaminophen’s risks, in part because it would harm Tylenol sales.

They also criticise the FDA, the US drugs regulator for not taking tougher action, but the agency said:

FDA officials said the agency saw the benefits of keeping acetaminophen widely available as outweighing the “relatively rare” risk of liver damage or death. Some patients cannot tolerate drugs such as ibuprofen, and for them acetaminophen may be the best option, said one agency official.

I do appreciate that the story gave a bit of context in quoting the figures for accidental deaths of ibuprofen, another non-prescription pain killer. The article says deaths due to ibuprofen overdose are negligible.

Massive coverup? Hardly

But is the fact that acetaminophen can cause liver damage being hidden by an avaricious company with complete disregard for public safety or by an over-stretched US drugs regulator? Hardly. Google “acetaminophen risk”. The first result in the US is WebMD. See risks:

When taken incorrectly, however, acetaminophen can cause liver damage. And your risk of liver damage may be increased if you drink more than three alcoholic drinks every day, take more than the recommended dose (overdose), or if you take any additional drugs that also contain acetaminophen at the same time.

Read a little further along under the next subhead, How to Use Acetaminophen Safely.

Make sure to use the correct dosage. Don’t take more acetaminophen than directed or take it more often than directed. Taking more than recommended can damage your liver — and won’t provide any more pain relief.

We’ve got a couple of bottles of acetaminophen that we have bought in the US. One bottle from US pharmacy Walgreens says, “See New Warnings Information”. It has a specific liver damage warning. It has in bold: “Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.” Both bottles warn not to take with other drugs that contain acetaminophen or if you drink three or more alcoholic drinks per day.

Ok, I thought. Maybe McNeil is trying to protect their brand, Tylenol, as the story says over and over again. I went to the Tylenol site, the official site for McNeil’s acetaminophen brand, and at the bottom of the page, granted not prominently displayed but there, is a link called: Tylenol labeling change.

New Dosing Instructions: Beginning Fall 2011
Acetaminophen, the active ingredient in TYLENOL®, can be found in more than 600 over-the-counter (OTC) and prescription medications, such as TYLENOL®, SUDAFED® Triple Action™, NyQuil®, Percocet® and Vicodin®.* Acetaminophen is safe when used as directed, but when too much is taken (overdose), it can cause liver damage. Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions.

To help encourage appropriate acetaminophen use, the makers of Extra Strength TYLENOL® have implemented new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength TYLENOL® (acetaminophen) products sold in the U.S. from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The dosing interval has also changed from 2 pills every 4 – 6 hours to 2 pills every 6 hours.

Emphasis mine. Was McNeil against educating the public because they worried about damaging sales of their flagship brand? It would seem not.

Education Campaign: Get Relief Responsibly™
In addition to the new dosing instructions on the OTC label, the makers of TYLENOL® launched Get Relief Responsibly™, an initiative designed to educate consumers about the appropriate use of OTC and prescription medications, particularly those containing acetaminophen, and the importance of reading and following medication labels. As a part of this initiative, the makers of TYLENOL® have created a new website The site includes an interactive Acetaminophen Finder tool to help consumers identify products that contain acetaminophen and build a personal acetaminophen medication list to share with their healthcare provider or pharmacist.

I don’t know how prominent the campaign was, as I live in the UK. And I thought that maybe they launched this quietly in response to the ProPublica investigation. Nope, the date on the page is autumn 2011. This would be consistent with the “See New Warnings Information” label on our bottle of Walgreen’s Pain Reliever PM. It undermines all the assertions in the investigation that McNeil has resisted efforts to reduce dosages or engage in public education.

Stating the obvious in thousands of words

These are facts hidden in plain view: Don’t take too much acetaminophen, especially with alcohol. Taking more than recommended won’t do you any good, and it could wreck your liver. As a matter of fact, we’re going to recommend taking less of our flagship product.

It took me 30 seconds to find the relevant info on WebMD, and another 30 seconds to quickly scan the Tylenol site. How long did it take ProPublica and This American Life? TWO YEARS AND $750,000. 

As an editor, I keep saying to myself: Where’s the story here? The headline, anodyne even by American standards, is “Use Only as Directed”. My response: No shit. I mean, really? If you use a drug above the recommended dosage, there is a risk. If McNeil has ruthlessly tried to cover up the idea that if you take too much of the drug it will wreck your liver, they’re doing a really poor job.

Labelling on US acetaminophen bottles undermine repeated assertions in the investigation that the FDA has resisted calls for clearly labelling about overdose risks, especially with respect to liver damage. It is clearly listed under Warnings, in bold, on both bottles of acetaminophen we have.

Where is the breaking news? Has the FDA covered up the fact that if you take too much of the drug you can die? No, it hasn’t. Easily available information, both online and on the packaging, is clear about the risks of taking an overdose. But the key thing is that if you take too much of anything, even water, it can kill you. In technical terms it’s called LD50, the median lethal dose.

Whist Pro Publica’s piece does remind the reader to be more careful about taking other medications that might have acetaminophen and to more carefully monitor dosage, it isn’t revealing any new information, nor is it exposing a cover-up.

The story includes a clock, counting how long it has been since the FDA created an expert panel to evaluate the safety of over-the-counter pain relievers. The agency has not yet completed its work. This is about as damning as the revelations gets:

From 2001 to 2010, annual acetaminophen-related deaths amounted to about twice the number attributed to all other over-the-counter pain relievers combined, according to the poison control data.

In 2010, only 15 deaths were reported for the entire class of pain relievers, both prescription and over-the-counter, that includes ibuprofen, data from the CDC shows.

If acetaminophen, at roughly 150 deaths per year, is twice the number of all other over-the-counter and prescription pain relievers combined, then doesn’t this undermine the entire assertion that the there is a pressing need for the FDA to have this expert panel deliver its findings? It doesn’t seem that pain killers as a class of drug are particularly dangerous at all.

Back to acetaminophen, in 2010, the last year the article has figures for fatal accidental acetaminophen poisoning, 166 Americans died. The CDC reported that 2,468,435 Americans died that year. The number who died from acetaminophen poisoning is 0.007 percent of total deaths in the entire country. Tragic? Yes. Common? Hardly. Ibruprofen deaths are negligible, especially compared with the 32,788 Americans who died in road traffic accidents. Journalists are incredibly poor at communicating relative risk, and this over-the-top investigation only serves to reinforce that. What pressing public health crisis has been identified at a cost of $750,000?

I don’t mean to dismiss the suffering of the nearly 150 people who died or of their friends and loved ones, and I think that this story is worth reporting, but in the right terms. For stories like this, I can even see the need to remind people every few years, just to drive home the point that taking too much acetaminophen is risky, especially if you drink a lot. However, I don’t think this story comes even close to rising to the standard of a two-year investigation costing hundreds of thousands of dollars.

Opportunity costs

Peter Osnos at The Atlantic praises the story and asks who will pay for expensive, investigative coverage. The piece seems to be equating the cost with impact. To me, as I said in a comment on the piece, this is not a piece for which we should be getting out our “yay investigative journalism” pom-poms. It proves that investigative journalism can be expensive, yes, but is it going to have an impact? This story will have no more impact than a run-of-the-mill public service piece that could have been bashed out in an afternoon.

Not all investigations lead to publication, and I know that some investigations take time to develop, but I cannot see why this story took two years and three-quarters of a million dollars to reveal information that can be found with a quick search online. As a journalist and editor, I have to ask what is the opportunity cost? The opportunity cost is:

The cost of an alternative that must be forgone in order to pursue a certain action. Put another way, the benefits you could have received by taking an alternative action.

In this era of scarce resources, it is even more important to ask what opportunities are foregone because resources are deploying elsewhere. It’s Econ 101, but it is an incredibly important question that we need to ask. Two years and three-quarters of a million dollars is a huge investment. It’s the kind of resource that most journalists would give their spare kidney for, but if we’re going to sink that kind of time and precious coin into a story, that story better be worth it.

When I started this post, I thought this was simply about an overly expensive investigation. It took me almost no time at all to undermine the core elements of this story with basic online research. McNeil, if they trying to bully the FDA into inaction, appear to have failed. If a minimal bit of online research calls into question key elements of this story, there are even bigger problems than the excessive cost and time.

UPDATE: I did originally post this under the headline “30 seconds to debunk”, which in retrospect is a bit harsh. ProPublica has meticulously documented their points to the point where I think they completely diluted the impact of the piece. If as a journalist, you want to draw attention to the dangers of the drug, the piece should have been much, much shorter, highlighted the low margin for error in taking more than the recommended dose, especially with alcohol and been done with it. The story has problems, and one of the biggest is that it is incredibly self-indulgent. It fails the most basic commandment of a good piece of journalism: Get to the point.

UPDATE 2: To clarify, the $750,000 is only the amount that ProPublica spent. I was just listening through the The American Life (TAL) report thoroughly, and ProPublica and TAL found that 86 percent of Americans know that acetaminophen can cause severe liver damage and two-thirds know that it can kill you. Yet, Ira Glass said that although many of his listeners already knew this, they were still going to spend an hour on the story.

10 thoughts on “ProPublica, This American Life and acetaminophen: $750,000 to state the obvious

  1. Totally agree…when someone takes 50% more dosage (3 Tylenol vs 2 Tylenol), whey would they believe there would not be consequences?

  2. It’s been what I considered common knowledge for 20 years or more that Tylenol should be consumed WITH food (i.e. never on an empty stomach) and never with alcohol, or it would blow your liver. It just seems like this is suddenly news to people who should have been paying attention all along. And suddenly news to them means its a BIG DEAL ™.

    FWIW, I always buy generic pain killers. I have no idea what McNeil has or has not been telling anyone but still I knew about the risks. Clearly I am doing something terribly wrong in knowing what I take.

    The far bigger problem, in my opinion, are the incessant TV ads which tell consumers, when you overdo it and screw up your knees/body, the easy/fast/best thing to do is take a pill. Once every 8 hours. Once every 10 hours! And you’re back to being SuperYou. The actual thing to do is listen to your body and not do the things that make it hurt. But then you’ll need less pills. Can’t have that.

    1. I think it is worth mentioning that doctors REGULARLY advise patients that they can take more than the suggested Tylenol dosage for various kinds of pain, usually because they don’t want to prescribe stronger painkillers. I’d listen to my doctor over the label, but hopefully this changes that.

      1. Mike,

        Yes, doctors in the UK also regularly say that you can take more than the suggested amount, even the 4000 mg prescription limit. I’d be a bit warier after the broadcast, but I still think it probably would have been more effective to do a brief story rather than an expensive 11,000 investigative piece. Thanks for the comment.

    2. PMDR, yes, the drugs ads in the US drive Suw, my British wife, nuts.

      On This American Life, I was really surprised when they quoted that their own ProPublica/This American Life poll found that 86 percent of Americans knew about the liver risks, but because all of their staff were in the 14 percent who didn’t know that it meant the story was still important. Hmmm… I will give the This American Life reporters credit, I thought it was more direct and to the point than the ProPublica piece. This American Life focused more on the slow process at the FDA to get the heightened warning on the bottles rather than push the McNeil line, which I thought ProPublica didn’t prove sufficiently. (McNeil is a division of Johnson & Johnson. The company makes Tylenol.)

      However, I still think a simple, straightforward public education piece would have been more effective. Thanks for the comment.

  3. As one of the story’s authors, I feel compelled to respond. While I am suitably impressed with your ability to use Google, I note that you would not find two primary points of the story on that otherwise admirable search engine, until we unearthed them. Namely:

    – “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 for 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.”

    Perhaps you believe that the liver warnings you were able to discover with your keyboard skills have solved all the problems. I would direct you to our editorial, which lists nine other public health steps that have been suggested by FDA advisors, outsiders and the company itself:

    We are well aware of relative risk issues. I assume that you are as well, and that you know an important part of public health is whether such RRs, however large or small they may be, can be reduced through reforms without altering the risk/reward calculation. In this case, the experts have said yes, and yet the FDA has failed to address such suggestions. You may wish to use Google to review the actions of the U.K. and many other national regulators in limiting paracetamol access. Or you could save yourself time and read our story, with documentation and context included.

    As to your point regarding McNeil’s decision to “encourage appropriate acetaminophen use,” you perhaps might have spent an additional amount of time Googling the company’s other products in the U.S. and around the world and wonder why they did not take the same steps for all of their products — a fact we discuss in our story, and that is not readily apparent from McNeil’s website.

    We did try to reach the tl;dr audience with interactive and social tools woven throughout the story. You apparently were not among them. The best I can offer “to get to the point” is our permalink with embedded tweets: Hopefully, five paragraphs is not too long for you.

    In the end, ProPublica is not the answer to the woes that beset investigative journalism. But neither are sloppy, ill-considered critiques that fail to demonstrate an understanding of the significant time and investment it takes to unearth information which those in power wish to keep from the public. Most journalists realize that going to the 3rd page of Google search results does not constitute shoe-leather reporting. I trust you do as well.

  4. Thank you for taking time to respond and engage. First, let me dispense with a straw man or two. I didn’t say that ProPublica was the answer to all the problems besetting investigative journalism, and I generally think the quality of its reporting, writing and innovative presentation is outstanding. I also don’t think that Googling is a replacement for original reporting.

    Let me clarify the primary issue I had with the piece. For me, whether I choose to engage with this story hinges on whether you prove to me that acetaminophen (paracetamol here in the UK) poses a serious, unmanageable risk to public health. Cutting through a lot of numbers in the piece, the topline figure that you quote in your main piece is on average 150 people die annually in the US due to accidental overdoses of acetaminophen, totalling 1,567 over the years between 2000 and 2010. That’s actually not a lot of people when put in the context of 2.5 m Americans dying in 2010 alone. According to the CDC 450 people die each year from falling out of bed, about three times more than are killed by accidental overdoses of this drug. You then give two anecdotes, one that involves the potential overdose death of a 12-year-old and another that involved liver failure of someone who drank possibly up to three alcoholic drinks around the time he took the drug. I do not wish to diminish the human tragedy of those deaths, but to me, despite your strenuous efforts, you only proved that the risk was both small and manageable. After that, the rest just seems like irrelevant detail rather than “information which those in power wish to keep from the public”. For most readers, they would probably move on after that, regardless of your efforts to engage the tl;dr crowd.

    I was going to leave my comment at that. However, once I start asking questions of your story, other bits started to unravel, and suddenly, you lost my trust as a reader. I will cite only one example. You say in your main story “Use only as directed” that:

    “Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually and results in 33,000 hospitalizations a year, federal data shows.”

    Ok, that seems relevant and worrying, but permit me to return to my falling out of bed stats for a little perspective. The CDC reported

    “In 2010, 2.3 million nonfatal fall injuries among older adults were treated in emergency departments and more than 662,000 of these patients were hospitalized.”

    However, then I took a closer look at both your main story and a sidebar. You do not qualify these numbers in the main story, but in your sidebar “Behind the numbers“, you add a few qualifiers and additional figures that should have been included with the figures quoted in your main story, maybe not in detail but certainly in some way. In the sidebar, you say:

    “The National Hospital Ambulatory Medical Care Survey, which is conducted by the CDC, estimates that an average of 44,000 people per year visited emergency rooms for acetaminophen overdoses between 2000 and 2007. About half of them overdosed by accident; the rest attempted suicide or their
    overdoses were of undetermined cause.

    “A Consumer Products Safety Commission survey estimates more than 78,000 patients a year go to emergency rooms for acetaminophen overdoses, with about 30 percent accidentally taking too much, the study found. The study authors speculated that the difference between the number of emergency-room visits arises from how the two research teams identified acetaminophen overdose cases.

    “According to yet another database, the CDC’s National Hospital Discharge Survey, about 33,000 people are hospitalized annually due to acetaminophen poisoning, with about 75 percent of them having intentionally overdosed, the study found.”

    Wait a minute? 75 percent of the hospitalisations are down to intentional overdoses? Don’t you think that’s relevant enough to be in the main story? I certainly do. That is absolutely necessary context for a reader to assess the actual risk of the drug when it is used as directed. You also only quote the higher ER visit number but not the lower number. Why did you choose the higher number for the main story? You don’t explain that in your sidebar either.

    At the end of your sidebar about the data, you very admirably admit what you don’t know, but conclude: “All we can say is that only a tiny fraction of people who take acetaminophen appear to suffer injuries or fatalities as a result.” Most every editor I’ve had would have asked: Where’s the story here? And that is why I asked: Why did it take two years and three-quarters of a million dollars?

  5. Very few people are capable of the type
    of research described in this piece. Therefore, the warning of overdose should have been more prominent and
    should have appeared earlier. The report
    was correct in suspecting that people who
    market Tylenol dragged their
    feet in warning the public of the possibility of an overdose.

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