"Use Only as Directed" - Act Two
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Ira Glass
It's This American Life. I'm Ira Glass. Today's program, "Use Only As Directed." Today's show reported alongside the investigative reporting team at ProPublica. And we're bringing you the story of one of the most popular drugs in the country, acetaminophen, the active ingredient in Tylenol. It also, according to federal data, causes more deaths than any other over-the-counter pain medication.
Each year, on average, over 150 people died of accidental overdose, 78,000 people land in the emergency room, 33,000 people are hospitalized-- again, this is all based on data from the federal government. McNeil Consumer Healthcare, the maker of Tylenol, as I said earlier in the show, disputes that its product is the deadliest over-the-counter pain medication.
And in the first half of the show, you heard about the FDA delaying action on labelling acetaminophen to a degree that was unusual, even for the FDA-- and, in fact, kind of mind-boggling. A panel recommended a warning about liver damage in 1977. It took 32 years for the agency to rule on that.
But you know, in a certain way, that pales compared to the confusion and delay surrounding infants' and children's acetaminophen. What's interesting about these products and this situation is that this is a situation where the maker of Tylenol, McNeil, did not oppose a new label on the packages. In fact, it was the opposite.
McNeil wanted the change. It actively urged the FDA to get clearer, better labeling on those products for years, saying that would make the product safer. And for years, the FDA did not fix the problem.
And McNeil didn't step in and fix the problem-- which, as you'll hear, it could have taken steps to do. And the problem lingered in a way that's kind of stunning. Again, here's reporter Sean Cole.
Sean Cole
Again, this all has to do with the nature of acetaminophen and how relatively easy it is to overdose. In this case, there's the added complicating factor of parents giving the drug to their kids. And these two formulas, Infants' Tylenol and Children's Tylenol, they're different. Infants' is actually for kids up to three years of age, and Children's is for kids up to 11 years of age. And this next part is going to sound really counter-intuitive, so I'll say it slowly.
For the longest time, Infants' Tylenol was three times stronger, three times more concentrated, than Children's Tylenol, the rationale being that it's harder to make a very young child, and especially a baby, swallow medicine. So if you make the medicine stronger, the parents will have an easier time of it. Makes sense on one level.
But if you ask toxicologist Barry Rumack, who's done research funded by McNeil and has testified as an expert witness on the company's behalf, there's a big problem, again with the labeling. Confusingly, he says, there aren't any dosing instructions for children under two on either product. All it says on the box is, "Ask a doctor." And for years, McNeil has been urging the FDA to change that. Here's Rumack.
Dr. Barry Rumack
I've been trying, and Tony Temple's been trying--
Sean Cole
Tony Temple is a former McNeil executive.
Dr. Barry Rumack
And everybody else has been trying since at least 1983 to get a dose on these labels that goes down preferably to two months of age.
Sean Cole
Because for one thing, if a baby's feverish and irritable at 3:00 in the morning, and there's no doctor around--
Dr. Barry Rumack
The mother or father want to give the Tylenol, and it says, under two years, ask a doctor. What are they going to do? They're going to guess at a dose. And they're going to say, you know, he's a little big for his age. You know, maybe I'll give him half of this.
Sean Cole
Half a dropperful.
Dr. Barry Rumack
Maybe I'll give him the whole thing.
Sean Cole
That's one scenario. Another is that parents might get the two different formulas mixed up, give their child the stronger medicine based on the instructions for the weaker medicine. It can happen.
Christina Hoyt
This is her when she was coming home.
Sean Cole
And it has.
Christina Hoyt
She's about three, four months there. She was a very, very big baby. Very big.
Sean Cole
Christina Hoyt had her first baby, Brianna, when she was 17 years old. Her then-husband Eric Hutto was 18. This was about 10 years ago, back in Louisiana, where they're from.
Christina lives near Denver now. Eric flew into town so we could talk to them both together. Both of them kept mentioning how big Brianna was when she was born.
Christina Hoyt
And it wasn't just that she was fat, but she was long, too. She would hang outside of her infant seat. It was just awkward.
Eric Hutto
Yes, if you walked behind, you could see her feet sticking up.
Christina Hoyt
[LAUGHS] Yeah.
Sean Cole
And she was pretty healthy.
Christina Hoyt
Yes.
Sean Cole
But then when she was about five months old--
Christina Hoyt
She got a cold. Chest congestion. She wasn't eating. She was extremely fussy.
Eric Hutto
High fever.
Christina Hoyt
Yeah, 102.
Sean Cole
Fever?
Christina Hoyt
Mm-hm. So they gave her Tylenol at the triage.
Sean Cole
The emergency room. Christina's mother came along, too. Now Christina had already started Brianna on Infants' Tylenol, and she says she showed the folks at the hospital the type she was using.
Christina Hoyt
And it came in a little bitty bottle, and the purple kind is what we gave her. I even pulled out the dropper, showed them how much I was giving her, and it was the first line on the dropper. Because we didn't know how much to give her. It says to consult a physician. So without knowing how much to give her, we just gave her the lesser of the doses of the Infants' Tylenol.
So they wrapped her in warm towels, broke her fever. The doctor came back in, said she just had a virus and that it would pass. So he gave us a script, wrote on a piece of paper, "3/4 teaspoon of Tylenol every four to six hours for pain, as needed."
So my mom questioned it and said, don't you think that's a little much for a baby of her size? And so the doctor gave it back to the nurse, the nurse went away, came back, scratched it out, and says 1 teaspoon of Tylenol. Nowhere does it say--
Sean Cole
Wait, she said, don't you think that's a little much? And he scratches it out and writes more?
Christina Hoyt
Yes. And he says because of her weight, that's how much she needs to be given.
Sean Cole
The hospital was going off a dosing chart it got from McNeil. McNeil had sent the chart around to doctors and hospitals as a kind of stop-gap until it was able to convince the FDA to put more specific dosing instructions on the boxes of Infants' and Children's Tylenol.
Now the FDA held its first public meetings about all this label confusion eight years earlier, in 1995. Christina and Eric were still in middle school when that happened. When Brianna arrived at the ER, it was 2003, and the problem still wasn't fixed. In fact, 2003 was the year that the FDA finally said, OK, now we're going to address this issue. And said the same thing in 2004, in 2005, 2006, 2007, and 2008.
T. Miller
And each year, the FDA doesn't act.
Sean Cole
Again, T. Miller with ProPublica.
T. Miller
And they actually put on their calendar for the year that we're going to address this this year, and then they just don't. And it just goes by and by and by, year after year after year.
Dr. Barry Rumack
The FDA's response was, it's a public health issue.
Sean Cole
Again, Barry Rumack, the toxicologist who argued for the dosing label. If this says, call a doctor under age two, then the parents are going to be required to call a physician, and they will get into the health care system. And that would be safer and better than trying to treat them by themselves.
That's the FDA's rationale for this?
Dr. Barry Rumack
Yes.
Sean Cole
The thing is, the Huttos did see a doctor. They had instructions from a doctor in their hands.
Christina Hoyt
So we gave her Infants' Tylenol, what we had given her before, a teaspoonful every six hours. And it was too much.
Sean Cole
As it turned out, the 1-teaspoon dose the doctor recommended was for the less-concentrated Children's formula. The hospital didn't normally use Infants' Tylenol.
Eric Hutto
They didn't tell us to give Children's or Infants' Tylenol, either of them.
Sean Cole
They just said Tylenol?
Eric Hutto
Right. So being that she was an infant child, you know, it was Infants' Tylenol. Because you wouldn't think to give a child Children's Tylenol at an infant's age, because you can't give a child adult Tylenol, you know?
Sean Cole
Eric and Christina said they followed the directions to the letter. Soon, Brianna Hutto wasn't fussy anymore. She was listless. Eric said it was like she was there, but not there, and her stomach felt hard. Eric and his father took Brianna back to the hospital.
Eric Hutto
Then they said, well, is she on any kind of medication? And I actually said, yeah, the Tylenol y'all prescribed her.
Sean Cole
When the doctors figured out she'd overdosed on Tylenol, Brianna was airlifted to New Orleans Children's Hospital, and then to a transplant center in Omaha a day and a half later. She just kept getting worse-- went into a coma, had tubes and wires all over her. The plan was to give her part of her mother Christina's liver, but first, Brianna would have to start breathing on her own again. The Omaha hospital put up Eric and Christine in a room down the hall from their daughter's.
Eric Hutto
I walked down there to go see here. And when I was walking down to go see here, they had a bunch of doctors running to her room, and they turned me around. And not long after that, they had a priest come walk in, and-- there was a couple people.
Christina Hoyt
Priest and a preacher.
Eric Hutto
Priest and a preacher. And they had a doctor or someone. They had a couple people came in, started talking to us, telling us what was going on, that her kidneys had shut down, her heart failed and everything, and that she had passed away.
Sean Cole
That's so awful.
Christina Hoyt
I don't really remember much after that.
Sean Cole
The Huttos ultimately filed suit against the doctor and the hospital, but also against McNeil. Their lawyer made the case that there should have been better dosing on the box, plus a severe liver damage warning. All of this happened about two years before McNeil put the liver warning on the Tylenol label.
The hospital admitted fault almost immediately, but McNeil fought. In the end-- this is just how the court system works in Louisiana-- the jury divvied up the blame, saying the hospital was 70% at fault, McNeil was 23% at fault, and Christina and her mother together were 7% at fault. McNeil was ordered to pay $1.1 million, but the company appealed. And appealed, all the way up to the Supreme Court. Just last October, the Supreme Court refused to hear McNeil's case.
Christina and Eric broke up after that. Both got remarried. Christina went on to have three more kids with her new husband. She says living with Eric would have been a constant reminder of what happened. And given the three-year appeals process, she already had to think about it too much.
From the reporting we've done, it seems clear that McNeil genuinely tried to make dosing infants and children less confusing for families like the Huttos. It argued for better instructions. It gave caregivers the dosing chart. Here's former McNeil executive Tony Temple at an FDA hearing in 2009.
Dr. Tony Temple
I believe the most important labeling improvement that could be made now would be to add dosing instructions for children less than two years of age to the label. If that had already been done, the other pediatric issues would be of much less concern. This is at the heart of the product confusion and misdosing issue we've heard so much about.
Sean Cole
When we asked the FDA about this, it said in a written statement basically that dosing instructions for babies, quote, "pose a number of challenges." They said parents might not know the weight of a child unless they've been to their pediatrician recently, so they should just go to the pediatrician. We asked, if weight- and age-based dosing present such a problem, why infants' and children's ibuprofen has it. The agency said, because it's a newer drug and went through a different drug approval process.
But where McNeil was arguing for clearer instructions, there's another strategy they could have taken, one that would have ended the confusion between the two products, and it wouldn't have had to have asked the FDA. The company could have just yanked the stronger-concentration product off the market. That's what PeterMax Miller says he would have done. He used to be involved in decisions like this-- whether to pull products from the market-- when he worked in the industry years ago, when he was at Bristol-Myers Squibb and at GD Searle. Now he teaches marketing ethics at the University of Colorado.
Petermax Miller
So I would not have had any hesitation at all about yanking it off the shelf overnight everywhere. And Johnson & Johnson knows how to do that.
Sean Cole
Johnson & Johnson, again, is McNeil's parent company. You might remember it pulled a ton of Tylenol off the market in the '80s due to a tampering scare in which some capsules were laced with cyanide.
Petermax Miller
And having said that, overnight is not fast enough either. But that's as fast as we can get.
Sean Cole
What would the trigger be?
Petermax Miller
If there was an infant death due to confusion, that's the time to pull it.
Sean Cole
One infant death?
Petermax Miller
Just one infant death. That is-- I want to say more than a trigger. That is a huge cannon.
Sean Cole
And ultimately, McNeil did pull the stronger concentration off the market, in 2011. Now when you go into a drugstore, you'll see both Infants' and Children's Tylenol, but it's the same stuff in two different packages.
Of course, more than one child died in the 18 years McNeil was asking the FDA to let it include better dosing instructions on the box. Tony Temple was asked about this on the witness stand during the Huttos' lawsuit. Again, he's the former McNeil exec who'd been vying for weight-based dosing.
Temple testified that you might go two, three, or four years without any death reports, and then there might be one in a given year. The attorney questioning him said, "And rather than pull the products off the shelf, that's sort of the cost of doing business?" Tony Temple-- "McNeil felt that the benefit as-- really, it's the FDA, because it hasn't pulled it off either. But the benefit to children having the product available was appropriate to keep it in the marketplace, yes."
I read that excerpt to PeterMax Miller. He said Temple's argument doesn't really make sense to him, because McNeil didn't need to wait for the FDA to take action with Infant Tylenol.
Petermax Miller
You know, from an industry standpoint, we know it's going to be slow at the FDA. So I cannot-- if I have a drug that's causing problems, or labeling that's causing problems with confusion, I cannot blame the FDA for being slow. The FDA does not care if you take something off the market, that I know of. You can do it overnight.
Sean Cole
We asked McNeil why it didn't move to a single concentration sooner, among other questions about this part of the story. The response said the company has a long history of being a responsible health care partner with regard to pediatrics. Then McNeil laid out a brief history of Infants' and Children's Tylenol, including the 2011 decision to take the stronger concentration off the market, which it said was not just something McNeil did, but all acetaminophen manufacturers. The company also said it made the dosing devices themselves safer for kids.
The company didn't send us any comments specifically about the Hutto case or any of the specific lawsuits we asked about. But it did address those cases more generally in that recorded statement from Medical Affairs VP Ed Kuffner.
Dr. Ed Kuffner
We're committed to preventing acetaminophen overdose. Even one patient who takes a significant overdose is one too many. Our hearts go out to those who've overdosed and gotten sick, and to the families and loved ones of those who've died.
Sean Cole
So let's run down what McNeil has done to try to prevent acetaminophen overdose. Again, there are now both alcohol and severe liver warnings on Tylenol, and the company has taken the stronger Infants' concentration off the market. The company put the alcohol and liver warnings on its products before it was required to by the FDA-- though after FDA advisory panels recommended them.
Also, as we mentioned at the beginning, the words, "contains acetaminophen-- always read the label," are going onto the cap of every Extra Strength Tylenol bottle. In addition, McNeil has done a bunch of its own public outreach on the issue, especially in the last few years, including a public service campaign called "Get Relief Responsibly." Plus McNeil was the one who funded the development of an antidote for acetaminophen poisoning, which surely has saved thousands of lives.
But despite its efforts, right now McNeil faces more than 85 lawsuits related to acetaminophen, many of them saying the company failed to warn the public about the true risks of the drug, and particularly the narrow margin between a safe dose and a toxic dose. At least 10 other countries have taken steps the US hasn't to try to prevent acetaminophen overdose. According to a 2008 FDA report, Australia, France, the UK, New Zealand, Germany, Finland, Denmark, Sweden, and Switzerland have limited how much of the drug you can buy at one time. Or they say you can only buy it from a pharmacy.
In the UK, for instance, they simply limited the package sizes. A lot of times it comes in those little blister packs, those little plastic-and-foil chewing-gum-looking packages, so you have to pop them out one at a time. Those rules went into place in 1998.
Since then, deaths from acetaminophen poisoning have dropped by more than 40%. That's all deaths, including suicides, and it's only for England and Wales. Scotland didn't see a decrease in deaths, for some reason.
In Canada, the package warnings say an overdose can be fatal. That word is not on over-the-counter acetaminophen products here. I also noticed, last time I was in Canada, that the stronger Infants' formula of liquid Tylenol is still on the shelf, but weight- and age-based dosing is on both Infants' and Children's Tylenol packages.
Here in the States, you could argue acetaminophen labeling has gotten a little more confusing lately. In 2009, an FDA advisory panel suggested that the recommended daily dose drop from 4 grams a day to 3 grams a day, hoping fewer people would end up overdosing. The FDA still hasn't taken action on that recommendation. But in 2011, McNeil did. It lowered the recommended dose on the label to 3 grams a day.
But the company still says 4 grams a day is a safe dose, so now this is what the label says. "The maximum daily dose of this product is 3,000 milligrams in 24 hours. Severe liver damage may occur if you take more than 4,000 milligrams of acetaminophen in 24 hours."
With so many people already buying acetaminophen, one of the ways companies can still boost sales is to put it in more and more products. More than 600 products contain acetaminophen now, including Excedrin, Theraflu Dristan Tablets, Sudafed Cold and Cough, Robitussin Cold and Flu, Alka Seltzer Plus Cold and Sinus, several types of Mucinex and Midol, most kinds of NyQuil, and stronger prescription painkillers like Percocet and Vicodin. The problem is, having it in so many products means that it's that much easier to accidentally take two drugs with acetaminophen in them at the same time-- say, Tylenol and NyQuil-- and inadvertently overdose yourself. McNeil, responsibly, makes a big point of this in its outreach these days.
Nonetheless, an independent national poll commissioned by ProPublica and This American Life shows a third of the public thinks it's safe to take the maximum recommended dose of Extra Strength Tylenol together with NyQuil. It's not. And a third say it's OK to give your kid the maximum recommended dose of Children's Tylenol along with Children's Tylenol Plus Multi-Symptom Cold Medicine. That's not OK either.
The proliferation of products, just how easy it is to double up, might be one reason why deaths from acetaminophen toxicity are much higher now than they were 20 years ago. An FDA report in 2008 noted that acetaminophen poisoning quadrupled and deaths went up seven-fold between 1995 and 2005. They're even higher today.
© 2012 Chicago Public Media & Ira Glass