Pro Publica
In U.S. Trial of Massacre Suspect, a Rare Chance for Guatemalan Justice
Sept. 24: This story has been updated with developments as the trial opened.
In a historic case with international repercussions, a federal trial begins today in Southern California of a former Guatemalan military officer accused of playing a lead role in the massacre of 250 men, women and children in the village of Dos Erres during Guatemala’s civil war in 1982.
Jorge Vinicio Sosa Orantes, a former lieutenant in an elite commando unit, faces charges that he concealed his involvement in the massacre from U.S. immigration authorities years later, when he obtained permanent residency and citizenship. Although he cannot be tried in the United States for the killings in Guatemala, U.S. prosecutors must prove his complicity to show that he lied on immigration forms when he said he had not served in the military or committed a crime. If convicted in the trial in federal court in Riverside, he faces a prison sentence of 10 years.
Units in the U.S. Justice Department and Immigration and Customs Enforcement specialized in investigating human rights violations have devoted considerable resources to the first U.S. trial related to a Guatemalan war crimes case of this type. The witnesses against Sosa are expected to include as many as four fellow ex-commandos and Ramiro Osorio. Osorio survived the massacre as a five-year-old and was abducted and raised by a commando, Santos Lopez Alonso. Osario now lives in Canada and has testified in other prosecutions in the United States and Guatemala.
Prosecutors had also intended to use the testimony of Oscar Ramírez Castañeda, who survived the massacre at age three and was abducted like Osorio. Ramirez was raised by the family of an officer who led the killer unit. ProPublica told the story of Ramírez, now a Boston restaurant worker and father of four, last year. He and his lawyer had met with investigators and prosecutors in recent months to prepare him as a witness against Sosa.
As the result of a judge’s ruling last week, however, Ramirez will not testify in Riverside after all, according to his lawyer, Scott Greathead. Greathead said Tuesday that prosecutors recently informed him that U.S. District Court Judge Virginia A. Phillips had upheld a defense motion seeking to prevent Ramirez’ testimony. Greathead said he did not know the grounds for the ruling. Because Ramirez was too young to remember the massacre, he would not be able to provide eyewitness testimony.
Sosa, a 55-year old karate instructor, denies guilt. In an interview with ProPublica last year, he said that he did not take part in the attack on Dos Erres on Dec. 7, 1982, a hellish day of rape, murder and destruction. Sosa said he was working on a civil affairs project 100 miles away. He accused prosecutors and human rights activists in Guatemala, where he faces criminal charges, of framing him. His lawyer has argued in court filings that Sosa did not knowingly lie on federal immigration forms because the questions were vague and he had reasons to believe his wartime actions were covered by Guatemalan amnesty laws.
The Dos Erres case has become emblematic of the fight for justice in Guatemala, where the impunity of the past and the impunity of the present intertwine. Many military officers implicated in atrocities in the civil war, which claimed more than 200,000 lives before ending in the mid-1990s, have eluded punishment because of the protection of corrupt security forces and powerful criminal mafias.
During the past two years, Guatemalan prosecutors succeeded in convicting five members of the 20-man elite unit that destroyed Dos Erres. Efraín Ríos Montt, the nation’s former dictator, has also been charged in the case as the mastermind of a military campaign that resulted in hundreds of similar mass killings in rural areas. In a separate prosecution in May, a Guatemalan court found Ríos Montt guilty of genocide, but his conviction was quickly thrown out on procedural grounds. Whether he will be retried remains uncertain.
The U.S. government, which once backed Guatemala’s armed forces as a Cold War bulwark in Central America, has conducted crucial investigations of its own. In addition to tracking down Sosa in Canada in 2011, federal investigators arrested three other commandos from the unit who had migrated to the United States. A former sergeant, Gilberto Jordan, admitted to his role in the massacre and pleaded guilty to immigration charges in Florida in 2010; he is serving 10 years in prison. Investigators found another ex-commando living illegally in California and deported him to Guatemala, where he was convicted in the massacre.
And a third former soldier, Santos Lopez Alonso, will testify in Riverside as part of an apparent plea agreement for charges of illegally re-entering the United States after deportation. Alonso will likely provide eyewitness testimony against Sosa, who was the fourth-highest ranking officer in a special strike force comprised of 20 commando instructors, according to Guatemalan court records.
In court testimony in Guatemala and during interviews last year with ProPublica, two other former commandos alleged that Sosa fired his rifle and threw a grenade into a village well that was piled with living and dead victims. U.S. authorities have said that those two veterans, Cesar Franco Ibañez and Fabio Pinzon, who live in an undisclosed country as protected witnesses, also will testify in Sosa’s trial. In addition, the witness list read in court Tuesday include Jordan, the ex-sergeant imprisoned in Florida, suggesting he may have agreed to testify against Sosa as well.
Ramírez, the younger Dos Erres survivor, grew up thinking he was the son of a heroic lieutenant in the Kaibiles, as the Guatemalan commandos are known. Ramirez came to the United States illegally as a young man. Only in 2011 did he learn from Guatemalan prosecutors that the man he believed to be his father had abducted him and led the massacre in which his mother and eight siblings died.
As a result of the investigation, last year Ramírez met his real father, Tranquilino Castañeda, who survived the rampage because he was in another village. Ramírez has been granted political asylum. His father is expected to travel from Guatemala to testify about the DNA tests that proved he and Ramírez are related. Those test results bolstered the evidence against the former commandos.
While Ramírez lived in the shadows as an illegal immigrant, Sosa obtained citizenship in both Canada and the United States thanks to bureaucratic breakdowns and a lack of scrutiny, according to documents and interviews. As the former lieutenant points out, he described his military service in detail — without mentioning Dos Erres — when he requested political asylum in San Francisco in 1985 on the grounds that he feared persecution by the guerrillas and the military in Guatemala. U.S. authorities rejected his application, but he promptly went to Canada and gained political asylum there — an official decision that has been questioned by U.S. and Canadian human rights advocates.
Sosa later moved to New York, married a U.S. citizen and obtained permanent residency in 1998. He told U.S. immigration officials that he had not served in the Guatemalan military, according to prosecutors, and the officials failed to detect his previous account of his combat experience on his asylum application from 1985. That information also slipped by when he obtained citizenship in 2008 in Southern California, where he ran several karate schools, U.S. officials say.
The trial is expected to last two weeks.
Podcast: Aloha, Mike Webb
For this week’s podcast, we wanted to give a special tribute to our vice president of communications, Mike Webb, as he leaves ProPublica to start a new chapter in Hawaii.
Mike has been with ProPublica for five years – since our second story – and has played a crucial role in our success, from crafting key media partnerships and launching our first public event to managing our ever-hopeful softball team (go, Impact!). He joins us for one last time in the Storage Closet Studio to talk about his favorite ProPublica investigations and the daily life in the ProPublica Comms Department.
You can listen to this podcast on iTunes and Stitcher. For more on Mike and his adventures post-ProPublica, follow him on Twitter: @gmikewebb.
And, because Mike can’t stop promoting ProPublica, here are links to the investigations he mentions in this episode:
- Tylenol: Use Only as Directed
- Revealed: The NSA’s Secret Campaign to Crack, Undermine Internet Security
- Dollars for Docs: How Industry Dollars Reach Your Doctors
- Fracking: Gas Drilling’s Environmental Threat
- The Deadly Choices at Memorial
- The Wall Street Money Machine
Discussion: Acetaminophen Risks, Safety Measures
During the last decade, more than 1,500 Americans have died from accidentally taking too much of an over-the-counter drug renowned for its safety: acetaminophen. Tens of thousands more have been harmed from liver damage associated with the drug.
Meanwhile, federal regulators have known about studies showing the risks associated with acetaminophen for decades. So has McNeil Consumer Healthcare, the Johnson & Johnson unit that built Tylenol into a billion-dollar brand. So how has acetaminophen become America’s most popular pain reliever, despite these risks?
Join ProPublica for a discussion of our investigation into how federal regulators delayed or failed to adopt measures designed to reduce the rising number of deaths and injuries from acetaminophen, and how McNeil, while it undeniably took steps to protect consumers, also fought repeatedly against safety warnings, dosage restrictions and other protective measures.
WHEN: Thursday, Sept. 26, 1 p.m. ET
WHO: ProPublica reporter T. Christian Miller (@txtianmiller) liver disease specialist Dr. William Lee and pharmaceutical marketing expert PeterMax Miller.
Tylenol’s Risks Not Fully Understood, Poll Shows
Americans have a spotty understanding of the risks of Tylenol, a nationwide poll conducted earlier this year shows.
About half said they are not aware of any safety warnings involving the drug. But 80 percent said that overdosing on the medicine could result in serious side effects.
Thirty-five percent of those surveyed said it was safe to mix Tylenol with another medicine that contains acetaminophen, the active ingredient in Tylenol. This practice is known as “double dipping” and can lead to accidental overdoses.
Taken together, the results suggest a mixed record of success for the labels on Tylenol packages intended to warn consumers about the dangers of the drug. It also suggests that the acetaminophen public awareness campaigns sponsored over the past several years by the U.S. Food and Drug Administration, the drug industry and McNeil Consumer Healthcare Products, the Johnson & Johnson unit that makes Tylenol have yet to be fully effective.
When taken as recommended, acetaminophen – known in many countries as paracetamol – is generally safe, with few side effects. But at higher amounts, it can damage the liver, sometimes with lethal consequences.
As an investigation by ProPublica reported last week, about 150 people die each year after accidentally ingesting too much acetaminophen, according to data from the Centers for Disease Control and Prevention. Tens of thousands more are sent to hospitals and emergency rooms for treatment from acetaminophen poisoning, studies show. The FDA now calls acetaminophen toxicity a “persistent, important public health problem.”
The telephone poll of 1,003 adults was conducted by Princeton Survey Research Associates International in February and March, and it has a margin of error of 3.5 percentage points. It was commissioned by ProPublica and This American Life, which produced a radio story on the risks of acetaminophen. Full results from the survey are here.
Are you aware of any safety warnings regarding Tylenol?
Safe
Not safe
Don't know-->Source: Princeton Survey Research Associates International (See result.)
Are there any safety warnings about consuming alcoholic drinks when using Tylenol?
Safe
Not safe
Don't know-->Source: Princeton Survey Research Associates International (See result.)
Is it safe to take Nyquil along with the maximum recommended dose of Extra Strength Tylenol?
Safe
Not safe
Don't know-->Source: Princeton Survey Research Associates International (See result.)
Fifty-one percent of poll respondents were unaware of any safety warnings associated with Tylenol. However, 68 percent correctly said that liver damage could result from taking too much of the drug, while 55 percent said that an overdose could lead to death.
To gauge whether these responses reflected a real knowledge of the dangers of overdosing, the poll also asked about problems that are not caused by excessive consumption, including heart palpitations, tingling in the fingers and severe brain damage. But large numbers gave the wrong answer. For example, almost half of those surveyed (49 percent) said incorrectly that overdosing could cause heart palpitations, calling into question how much Americans truly understand about the risks of overdosing on acetaminophen.
A little more than half of those surveyed – 54 percent – said they had heard of warnings about mixing Tylenol and alcohol. Studies have shown that alcohol can make the liver more susceptible to damage from the drug. The FDA warns consumers on product labels against taking acetaminophen after three drinks.
Sizeable numbers of Americans also said they believed it was safe to take several different medications containing acetaminophen at once, the poll found.
For instance, 35 percent of respondents said it was safe to combine the maximum recommended dose of Extra Strength Tylenol with NyQuil, a cold remedy that also contains acetaminophen. It is not, according to the FDA.
People who take multiple acetaminophen products may inadvertently exceed the FDA’s maximum recommended daily dose of 4 grams, or eight extra strength acetaminophen pills. The FDA has cited reports of people suffering liver injury after taking between 5 and 7.5 grams per day over several days. ProPublica has created a simple app that allows people to look up how much acetaminophen is in many common drugs.
Regulators worry that people don’t understand that many medicines contain acetaminophen – more than 600 in all, including commonly used prescription drugs such as Vicodin and Percocet.
Michael S. Wolf, a professor at Northwestern University’s medical school, has studied double dipping and says the practice is “a reflection of how horrible our health system is at communicating the active ingredients” in medications.
The FDA has required over-the-counter acetaminophen to carry a warning that the drug can cause “severe liver damage” since 2009. While it mandates that prescription medications containing acetaminophen warn that overdosing can lead to “death,” no such warning is required for over-the-counter acetaminophen. About 60 percent of the drug is sold without a prescription.
The FDA’s Safe Use Initiative provides advice on how to correctly use acetaminophen through pamphlets, a webpage and YouTube videos, the most popular of which has been seen some 19,000 times since it debuted in January 2011.
“Public education and public campaigns are not something that the FDA is well resourced for,” said Dr. Sandra Kweder, an FDA official who helps regulate the drug and appears in the video.
The maker of Tylenol – McNeil Consumer Healthcare, a division of Johnson & Johnson – sponsors its own informational website, Get Relief Responsibly. The company also has created television advertisements, posters for doctors’ offices and a YouTube channel to educate consumers.
“McNeil has been a leader in educating doctors and providing materials about overdose and misuse of medicines containing acetaminophen,” the company said in a statement. It said its “acetaminophen awareness messages have been seen over one billion times.”
The Consumer Healthcare Products Association, an industry group representing McNeil and other acetaminophen makers, has worked in consultation with the government to create the Know Your Dose education campaign.
“We want to be as constructive and helpful as we can, to say, ‘Read and follow the label, taking too much can lead to liver damage, and don’t take two products at the same time,’” said Emily Skor, vice president of communications for the organization.
The $13 Test That Saved My Baby’s Life. Why Isn’t it Required For Every Newborn?
On July 10, my wife gave birth to a seemingly healthy baby boy with slate-blue eyes and peach-fuzz hair. The pregnancy was without complications. The delivery itself lasted all of 12 minutes. After a couple of days at Greenwich Hospital in Connecticut, we were packing up when a pediatric cardiologist came into the room.
We would not be going home, she told us. Our son had a narrowing of the aorta and would have to be transferred to the neonatal intensive care unit at NewYork-Presbyterian Hospital at Columbia, where he would need heart surgery.
It turned out that our son was among the first in Connecticut whose lives may have been saved by a new state law that requires all newborns to be screened for congenital heart defects.
It was just by chance that we were in Connecticut to begin with. We live in New York, where such tests will not be required until next year. But our doctors were affiliated with a hospital just over the border, where the law took effect Jan. 1.
More Resources: Which States Require This Screening?American Academy of Pediatrics legislation tracker
Newborn Foundation screening progress map
As we later learned, congenital heart problems are the most common type of birth defect in the United States. The Centers for Disease Control and Prevention estimate that about one in 555 newborns have a critical congenital heart defect that usually requires surgery in the first year of life.
Many cases are caught in prenatal ultrasounds or routine newborn exams. But as many as 1,500 babies leave American hospitals each year with undetected critical congenital heart defects, the C.D.C. has estimated.
Typically, these babies turn blue and struggle to breathe within the first few weeks of life. They are taken to hospitals, often in poor condition, making it harder to operate on them. By then, they may have suffered significant damage to the heart or brain. Researchers estimate that dozens of babies die each year because of undiagnosed heart problems.
The new screening is recommended by the United States Department of Health and Human Services, the American Heart Association and the American Academy of Pediatrics. Yet more than a dozen states — including populous ones like Massachusetts, Pennsylvania, Florida, Georgia, Wisconsin and Washington — do not yet require it.
The patchy adoption of the heart screening, known as the pulse oximetry test, highlights larger questions about public health and why good ideas in medicine take so long to spread and when we should legislate clinical practice.
Newborns are already screened for hearing loss and dozens of disorders using blood drawn from the heel. The heart test is even less invasive: light sensors attached to the hand and foot measure oxygen levels in the baby’s blood. This can cost as little as 52 cents per child.
Our son’s heart defect was a coarctation of the aorta, a narrowing of the body’s largest artery. This made it difficult for blood to reach the lower part of his body, which meant that the left side of his heart had to pump harder.
In the hospital, though, he appeared completely healthy and normal because of an extra vessel that newborns have to help blood flow in utero. But that vessel closes shortly after birth, sometimes revealing hidden heart problems only after parents bring their babies home.
Depending on the heart defect, the onset of symptoms can be sudden.
This is what happened to Samantha Lyn Stone, who was born in Suffern, N.Y., in 2002. A photograph taken the day before she died shows a wide-eyed baby girl lying next to a stuffed giraffe. The next morning, her mother, Patti, told me, she was wiping Samantha’s face when she heard a gurgle from the baby’s chest.
Before her eyes, Samantha was turning blue. Blood began to spill from her mouth. Ms. Stone dialed 911, and minutes later, a doctor who heard the call over a radio was there performing CPR. Samantha went to one hospital and was flown to another.
But the damage was irreparable. Samantha had gone 45 minutes without oxygen: She lapsed into a coma and died six days later.
It wasn’t until several years later that Ms. Stone learned about the pulse oximetry test. “This could have saved my daughter,” she told me. “There is no parent that should ever have to go through what I went through.”
Pulse oximetry is not a costly, exotic procedure. Most hospitals already have oximeters and use them to monitor infants who suffer complications. You can buy one at Walmart for $29.88.
A recent study in New Jersey, the first state to implement the screening, estimated that the test cost $13.50 in equipment costs and nursing time. If hospitals use reusable sensors similar to those found on blood-pressure cuffs, the test could cost roughly fifty cents.
As medical technology advances, few screenings will be so cheap or simple. Recent years have seen controversy over prostate cancer and mammography screenings. Medical ethicists have to weigh the costs of each program and the agony caused by a false positive against the lives saved.
But with pulse oximetry, the false positive rate is less than 0.2 percent — lower than is seen for screenings newborns already get. The follow-up test is usually a noninvasive echocardiogram, or an ultrasound of the heart. A federal advisory committee came down in favor — three years ago.
“There’s really no question, scientifically, this is a good idea,” said Darshak Sanghavi, a pediatric cardiologist and a fellow at the Brookings Institution. “The issue is, how do we change culture?”
Opposition has taken two forms. One is from doctors who believe policy makers shouldn’t interfere with how medical professionals do their jobs. The other is from smaller hospitals, which worry about access to echocardiograms and the costs of unnecessary transfers.
These concerns can be addressed fairly easily. Nurses in New Jersey and elsewhere have been able to work the test into their normal routines. A rural hospital should already have a protocol to transfer a newborn in serious condition. If Alaska can do it, less remote states can, too.
But this is not simply a rural health care problem. Cardiologists and neonatologists I’ve spoken with said they knew of hospitals in New York City, Boston and metropolitan Atlanta that weren’t screening newborns for heart defects.
“It’s completely the luck of the draw of where you deliver,” said Annamarie Saarinen, who has pushed for the screening since her daughter narrowly avoided leaving the hospital with an undetected heart defect.
Fortunately, our son’s condition was also caught and corrected. The only lasting effects are a three-inch scar on his side and checkups with a cardiologist. He will live a normal life. He will be able to play sports and climb things he’s not supposed to.
Shouldn’t every baby have that chance?
Plenty of Misconduct, and 129 Pages of One Judge’s Disbelief
Judge Kurt Engelhardt’s decision overturning the convictions of five New Orleans police officers for their roles in the Danziger Bridge shootings runs to 129 pages. Page by page, the decision addresses claims of prosecutorial misconduct, and it is as if, page by page, the judge’s anger and disbelief only grow.
He finds ample misconduct, and terms it “grotesque.” He uncovers other damning material, and professes “shock and dismay.” In the end, he closes with a distinct sense of foreboding: The worst may be yet to come.
“One can only wonder what other unanticipated revelations might be in store,” he writes.
Engelhardt’s central finding was that federal prosecutors, during the trial of the officers for the shooting of unarmed civilians days after Hurricane Katrina, had posted anonymous comments on the website of the local newspaper, the Times Picayune.
Here’s how Engelhardt characterized those comments: “inflammatory invectives,” “accusatory screeds,” “vitriolic condemnations,” all of them directed at “the defendants, their attorneys, their witnesses, their evidence.”
Engelhardt said that the online misconduct – prosecutors in New Orleans and at the Department of Justice in Washington posted comments themselves and encouraged other anonymous people to post, as well – created a “carnival” atmosphere, “wherein justice was distorted and perverted.”
ProPublica has spent much of the last year investigating prosecutorial misconduct, how the innocent can be convicted and how infrequently the offending prosecutors get punished. Much of the misconduct has been committed by state prosecutors, and the assumption among many is that federal prosecutors are more sophisticated and better trained, and thus less susceptible to bad or illegal behavior.
But the remarkable passages across Engelhardt’s decision do serious damage to that assumption.
- The senior federal prosecutor Engelhardt assigned to independently investigate the possibility that attorneys in the New Orleans office were posting comments online wound up having to admit that she, in fact, was among the guilty.
- The prosecutor in Washington who posted online during the trial was, it turned out, the woman who had led the prosecution’s “taint team,” a group of attorneys whose job was to protect the constitutional rights of the accused officers.
- The Justice Department’s Office of Professional Responsibility, charged in 2012 with investigating the initial report of online posting by a senior prosecutor in New Orleans, failed in its initial investigation to ask whether any other prosecutors in the office had done similarly.
- Engelhardt, in the course of his inquiry, came to suspect that reports being filed by the outside prosecutor he’d enlisted in the name of objectivity were being edited by senior officials at the Justice Department to make them less damning.
“Some may consider the undersigned’s view of the cited rules and regulations as atavistic,” Engelhardt writes at one point. “But courts can ignore this online ‘secret’ social media misconduct at their own peril. Indeed the time may soon come when, some day, some court may overlook, minimize, accept, or deem such prosecutorial misconduct harmless ‘fun.’” Today is not that day.”
The Justice Department responded to Engelhardt’s ruling by saying it was disappointed and reviewing its options. Neither the department nor the individual prosecutors cited by Engelhardt have publicly responded to his specific findings of misconduct.
Engelhardt’s ruling certainly amounted to a huge embarrassment for federal prosecutors. The prosecution of the officers had been hailed as a civil rights triumph. When the indictments were announced in 2010, the Justice Department said they were “a reminder that the Constitution and the rule of law do not take a holiday – even after a hurricane.”
Now, prosecutors will have to decide whether to re-try the officers. Four had been charged in the killing of two civilians and the injuring of others, and the fifth was charged with attempting to cover up the incident. Engelhardt, in his decision, recognized that the prospect of a re-trial, for the victim families and the officers, would be painful. But he found there was no acceptable alternative.
“This case started as one featuring allegations of brazen abuse of authority, violation of the law, and corruption of the criminal justice system,” Engelhardt wrote. “Unfortunately, though the focus has switched from the accused to the accusors, it has continued to be about those very issues. After much reflection, the court cannot journey as far as it has in this case only to ironically accept grotesque prosecutorial misconduct in the end.”
Engelhardt began his inquiry into the case he had overseen when the officers asked him to toss the verdicts. The officers cited reports that one senior prosecutor in New Orleans had posted online before and during the trial, ultimately calling for guilty verdicts against all five. It would take more than a year for Engelhardt to get the answers to what, for him, became a growing list of questions.
“The court has continued to receive more and more information,” he writes early in his decision, “albeit in the fashion of peeling layers of an onion.”
Over the months, the U.S. Attorney in New Orleans resigned because of the online misconduct of his office. Soon after, the senior prosecutor Engelhardt had asked to help him get to the bottom of the matter in the Danziger case, Jan Mann, resigned as well. She had posted online, too, even though she never told that to the judge when he enlisted her help.
Eventually, Engelhardt got two prosecutors from Georgia to take over the Danziger misconduct inquiry. But they had to file four separate reports before Engelhardt was satisfied he was being told something like the full truth. Along the way, he challenged them to reassure him their reports were not being sanitized by superiors. The prosecutors insisted, orally and in written responses, that they had maintained editorial control throughout.
In his decision, Engelhardt tried to capture the escalating trouble he was learning of, saying his first findings had “clearly blossomed into a series of newly discovered facts and admissions, unanswered questions, additional apostasies, and a fetor extending far beyond the simple disconcerting notion of a single rogue prosecutor.”
Engelhardt, upset by the online misconduct, was then moved to think again about some things that had troubled him at trial. In his decision, he blasts prosecutors for having threatened possible defense witnesses, notes that the testimony of one prosecution witness differed dramatically from what he had told federal investigators, and wonders why another prosecution witness had worked for the federal government despite having admitted to a series of crimes.
In tones of exasperation and sarcasm, Engelhardt writes that he found it “odd” that it took months for him to be told that one of the prosecutors involved in the online posting was the Washington attorney who had effectively represented the interests of the officers in the case. He later writes that he finds its almost unthinkable that she did what she did – write posts encouraging anonymous commenters on the case to keep up their criticism of the defense being put forward by the officers.
“It is difficult to accept the story that an experienced trial attorney in the criminal section of the DOJ’s civil rights division, sitting in Washington, D.C., during this trial, 'would embark on such a wanton reckless course of action.'” The attorney, Karla Dobinski, formally admits to the postings during Engelhardt’s inquiry, conceding it was wrong and that she had as a result sought to conceal her true identity.
It is unclear whether the prosecutors involved might face some sort of sanction. Engelhardt, for his part, says that question is up to others.
“The court leaves to the various bar associations and other attorney regulatory bodies the question of who knew what, when they knew it, and whether they discharged ethical and professional responsibilities to report/disclose it.”
But Engelhardt is clear in his decision about what he asserts is the damage already done, saying his investigation had led “to a dark benthic place of prosecutorial misconduct.”
The myriad acts of misconduct, he writes, were “committed by those with significant authority who act in the name of the ‘United States of America’ when they enter court and at all other times, and who have now left a fractured public trust.”
Use Only as Directed
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By Jeff Gerth and T.Christian Miller, ProPublica, Sept. 20, 2013, 10:00 a.m. Design & Development: By Krista Kjellman Schmidt, Lena Groeger, Al Shaw
During the last decade, more than 1,500 Americans died after accidentally taking too much of a drug renowned for its safety: acetaminophen, one of the nation’s most popular pain relievers.
Acetaminophen – the active ingredient in Tylenol – is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver.
Major Takeaways1 About 150 Americans die a year by accidentally taking too much acetaminophen, the active ingredient in Tylenol, federal data from the CDC shows.
2 Acetaminophen has a narrow safety margin: the dose that helps is close to the dose that can cause serious harm, according to the FDA.
3 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.
4 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.
5 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.
LinkDavy Baumle, a slender 12-year-old who loved to ride his dirt bike through the woods of southern Illinois, died from acetaminophen poisoning. So did tiny five-month-old Brianna Hutto. So did Marcus Trunk, a strapping 23-year-old construction worker from Philadelphia.
The toll does not have to be so high.
The U.S. Food and Drug Administration has long been aware of studies showing the risks of acetaminophen – in particular, that the margin between the amount that helps and the amount that can cause serious harm is smaller than for other pain relievers. So, too, has McNeil Consumer Healthcare, the unit of Johnson & Johnson that has built Tylenol into a billion-dollar brand and the leader in acetaminophen sales.
Yet federal regulators have delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen overdose, which the agency calls a “persistent, important public health problem.”
The FDA has repeatedly deferred decisions on consumer protections even when they were endorsed by the agency’s own advisory committees, records show.
In 1977, an expert panel convened by the FDA issued urgently worded advice, saying it was “obligatory” to put a warning on the drug’s label that it could cause “severe liver damage.” After much debate, the FDA added the warning 32 years later. The panel’s recommendation was part of a broader review to set safety rules for acetaminophen, which is still not finished.
Four years ago, another FDA panel backed a sweeping new set of proposals to bolster the safety of over-the-counter acetaminophen. The agency hasn’t implemented them. Just last month, the FDA blew through another deadline.
Regulators in other developed countries, from Great Britain to Switzerland to New Zealand, have limited how much acetaminophen consumers can buy at one time or required it to be sold only by pharmacies. The FDA has placed no such limits on the drug in the U.S. Instead, it has continued to debate basic safety questions, such as what the maximum recommended daily dose should be.
Safety DelayIn the 1970s, the Food and Drug Administration appointed an expert panel to review the safety and efficacy of over-the-counter pain relievers, including acetaminophen, the active ingredient in Tylenol. The panel delivered their recommendations on April 5, 1977. At the time, the FDA estimated it would issue final regulations before the end of 1978. The agency has still not completed its work. This is how much time has passed since then. Find out more »
Twitter Facebook LinkFor its part, McNeil has taken steps to protect consumers, most notably by helping to fund the development of an antidote to acetaminophen poisoning that has saved many lives.
But over more than three decades, the company repeatedly fought against safety warnings, dosage restrictions and other measures meant to safeguard users of the drug, according to company memos, court records, documents obtained under the Freedom of Information Act, and interviews with hundreds of regulatory, corporate and medical officials.
In the 1990s, McNeil tried to create a safer version of acetaminophen, an effort dubbed Project Protect. But after the initiative failed, the company kept its experiments confidential, even when the FDA inquired about the feasibility of developing such a drug.
Later, McNeil opposed even a modest government campaign to educate the public about acetaminophen’s risks, in part because it would harm Tylenol sales.
All the while, it has marketed Tylenol’s safety. Tylenol was the pain reliever “hospitals use most,” one iconic ad said. The one “recommended by pediatricians,” said another. “Safe, fast pain relief,” its packages promised.
In written responses to questions for this story, as well as a pre-recorded statement by its vice president for medical affairs, McNeil said it has always acted to ensure its products were used safely.
“McNeil takes acetaminophen overdose very seriously, which is why we have taken significant steps over the years to mitigate the risk,” the company wrote. McNeil has engineered safety packaging and spent millions on research, education and poison control centers that advise people who have overdosed.
The company said that science on acetaminophen had evolved over time and that it had implemented safety measures accordingly. Most recently, it announced it will soon add red lettering to the caps of medicine bottles saying they contain acetaminophen and that users should read the label.
In several cases, after FDA advisors recommended the agency enact safety measures over McNeil’s objections, the company adopted them before the agency forced it to do so. The company then said it was taking such steps voluntarily. McNeil also stressed that it has always followed FDA regulations.
McNeil objected to the thrust of questions from ProPublica and This American Life, saying they indicated “a clear bias” in favor of plaintiff’s lawyers who are suing the company.
The company declined to answer questions about individual cases of death or injury. “Our hearts go out to those who have suffered harm from acetaminophen overdose, and to the families of those who lost their lives as a result,” McNeil wrote in its statement.
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.
Accidental Deaths by Acetaminophen PoisoningHow many people have died by accidentally overdosing on acetaminophen each year.
1,567
Number of people who have died from 2001 through 2010 from inadvertently taking too much acetaminophen. Source: U.S. Centers for Disease Control and Prevention Multiple Cause of Death database TwitterFacebook Link Brianna's Story: "She Didn't Have a Second Christmas"The FDA has bolstered acetaminophen warnings as new science about the drug emerged, the agency said in a statement.
But FDA officials acknowledged the agency had moved sluggishly to address the mounting toll of liver damage caused by acetaminophen. They blamed changing research, small budgets, an overworked staff and a cumbersome process for changing rules for older drugs such as Tylenol slowing them down.
The agency has greater authority over prescription drugs, and it has already slapped medications containing acetaminophen with a “black box warning” that says overdosing can lead to “liver transplant and death.” Paradoxically, the same medicine sold over the counter does not tell patients that death is a possible side effect.
“Among over-the-counter medicines, it’s among our top priorities,” said Dr. Sandy Kweder, one of the FDA’s top experts on acetaminophen. “It just takes time.”
Many doctors believe in acetaminophen and some medical associations advise patients to take it for mild to moderate pain or reducing fever. “Given the number of doses given annually, the track record is incredibly safe,” said Dr. Bill Banner, a pediatrician and the medical director of the Oklahoma Poison Control Center.
Every over-the-counter pain reliever can cause harm. Even without overdosing, aspirin and ibuprofen can lead to stomach bleeding. In extremely rare cases, according to the FDA, recommended doses of ibuprofen and acetaminophen can provoke a skin reaction that can kill.
But the FDA says acetaminophen carries a special risk. About a quarter of Americans routinely take more over-the-counter pain relief pills of all kinds than they are supposed to, surveys show. That behavior is "particularly troublesome" for acetaminophen, an FDA report said, because the drug's narrow safety margin places "a large fraction of users close to a toxic dose in the ordinary course of use.”
The FDA sets the maximum recommended daily dose of acetaminophen at 4 grams, or eight extra strength acetaminophen tablets. That maximum applies to both over-the-counter and prescription drugs with acetaminophen.
Taken over several days, as little as 25 percent above the maximum daily dose – or just two additional extra strength pills a day – has been reported to cause liver damage, according to the agency. Taken all at once, a little less than four times the maximum daily dose can cause death. A comparable figure doesn't exist for ibuprofen, because so few people have died from overdosing on that drug.
About as many Americans take ibuprofen as take acetaminophen, according to consumer surveys from the mid-2000s.
The U.S. Centers for Disease Control and Prevention and the American Association of Poison Control Centers collect data on the number of deaths associated with each drug, but the figures are incomplete, making comparisons subject to question. McNeil contends the databases do not contain the information needed to draw conclusions about the relative risks of different medicines. The company and some epidemiologists maintain that these data sets undercount deaths resulting from chronic use of naproxen, ibuprofen and similar pain relievers. (More on the numbers can be found here.)
Still, the data show that acetaminophen is linked to more deaths than any other over-the-counter pain reliever.
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.
That same year, 321 people died from acetaminophen toxicity, according to CDC data. More than half – 166 – died from accidental overdoses. The rest overdosed deliberately or their intent was unclear. For the decade 2001 through 2010, the data shows, 1,567 people died from inadvertently taking too much of the drug.
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. Acetaminophen is also the nation’s leading cause of acute liver failure, according to data from an ongoing study funded by the National Institutes for Health.
Behind these statistics are families upended and traumatized and, in the worst cases, shattered by loss.
Udosha Baumle sits by the gravestone of her son Davy, who died at age 12 of liver failure after taking Maximum Strength Tylenol Sore Throat. (Melanie Burford for ProPublica)
TwitterFacebookLinkJust before Christmas 1999, 12-year-old Davy Baumle came down with a sore throat. For a week, his parents, David and Udosha Baumle, gave him Maximum Strength Tylenol Sore Throat, measuring out doses of the thick syrup.
But instead of getting better, Davy became listless. On Christmas Day, he threw up blood. His father took him to a local emergency room wrapped in a fuzzy brown blanket. A few days later, the boy was declared brain dead.
“They tell you it’s medicine… They don’t tell you it can kill you.”David Baumle, father of Davy Baumle
TwitterFacebook LinkThe Baumles later sued McNeil, claiming the company had failed to warn consumers of its product’s lethal danger. At trial, they testified they never gave Davy more than the recommended dose, 4 grams per day, or eight tablespoons. An expert for the company testified that lab work suggested the boy had ingested more, 6 to 10 grams, over several days.
The difference amounted to as little as 4 tablespoons a day, but the company prevailed, persuading the jury that the Baumles had not used Tylenol precisely as specified.
David Baumle said he would never have given his son the drug if he knew it was potentially lethal. At the time, the label simply warned of “serious health consequences” in case of overdose.
“They tell you it’s medicine,” he said. “They don’t tell you it can kill you.”
McNeil Consumer Healthcare, maker of Tylenol. Insiders call it The Fort. (J. Kyle Keener for ProPublica)
Tylenol was born in 1955, when the family-owned McNeil Laboratories introduced a liquid for children called Tylenol Elixir.
The drug’s key ingredient, acetaminophen, was developed in the late 1800s in Germany’s coal tar industry. McNeil seized on the drug’s potential after American research suggested that the medication does not cause stomach bleeding, as aspirin can. McNeil named the product based on letters in the chemical term for acetaminophen, N-acetyl-p-aminophenol.
Johnson & Johnson acquired McNeil in 1959, the same year that Tylenol was approved for over-the-counter sales. Soon thereafter, the first adult version of Tylenol rolled off the company’s production line in Fort Washington, Pa., the site of McNeil’s current headquarters.
Unlike companies that develop prescription drugs, McNeil has no patent on acetaminophen, and so no right to sell it exclusively. Virtually every drug store stocks generic acetaminophen, usually on the same shelf as Tylenol. To sell Tylenol at a premium, the company had to persuade customers they were getting extra value.
Tylenol has had “generic competition for 40 years,” said Ashley McEvoy, then the president of McNeil, in a webcast interview posted in 2008. “If I look back at what’s garnered success for McNeil, it’s the enduring value of brands.”
The company aimed its early sales pitches at doctors, according to a company history, working to persuade them to recommend Tylenol as a safer alternative to aspirin. To this day, the company’s formula for success hinges on positioning Tylenol as safer than other painkillers and more trustworthy than generics.
“If I look back at what’s garnered success for McNeil, it’s the enduring value of brands.”Ashley McEvoy, former president of McNeil, the Johnson & Johnson unit that makes Tylenol
LinkPerhaps the most famous chapter in McNeil’s corporate history is its response when several people in the Chicago area died in 1982 after taking Tylenol laced with cyanide.
The mysterious deaths terrorized the country — and raised questions about the safety of the company’s products. But in what later became a business school case study, McNeil removed Tylenol from the market, offered refunds and eventually developed tamper-resistant pills. By the end, it had transformed a disaster into a public relations coup.
McNeil’s marketing campaigns for its master brand were also skillful, burnishing Tylenol’s image while usually avoiding claims of absolute safety or zero side effects. One slogan: “The brand of pain reliever that doctors recommend more than any other.” Another: “Trust TYLENOL. Hospitals do.”
“We never use the word ‘safe’ in our advertising,” said Anthony Temple, McNeil’s longtime medical director, in a legal case in 1993. “We will say ‘a superior safety profile’ or some language to suggest its relative safety to other” over-the-counter pain relievers.
A History of AdvertisingMarketing prowess helped turn Tylenol into one of America’s most popular pain relievers. Over the past decade, McNeil Consumer Healthcare, the unit of Johnson & Johnson that makes Tylenol, has often spent more than $100 million per year on advertising the drug, according to advertising trade publications. See ads and commercials from some of the company’s campaigns.
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McNeil’s advertising budget for Tylenol has frequently exceeded $100 million per year: $115 million in 2003, according to Brandweek; $138 million in 2005, according to Advertising Age; and $162 million in 2008, according to Adweek. In 2004, marketing was the largest department in the company, employing about 150 professionals, McEvoy said in a court deposition.
McNeil’s recent chief executives have often come from marketing backgrounds. Johnson & Johnson, a conglomerate of more than 250 companies, does not even place McNeil into its pharmaceutical division, which is responsible for prescription drug products. Instead, the company is part of the consumer division, along with shampoo, mouthwash and skin care products.
Johnson & Johnson does not release sales figures for individual products, but Tylenol is the dominant acetaminophen brand in the U.S. Although the drug is available in cheaper generic forms, McNeil accounted for nearly half of all over-the-counter sales of acetaminophen, according to a 2010 McNeil presentation.
googletag.display('google-Rt_Sdbr_Non-Mobile-Only300x250');Sales of acetaminophen by all companies have also grown. It became the nation’s most-used drug in the mid-2000s, according to surveys. In 2009, more than 27 billion doses of acetaminophen were sold in the U.S., most over the counter.
One way McNeil has reached ever-more households is through a marketing strategy known as line extension: targeting market niches by adding products, all under the halo of the Tylenol brand. Between 1988 and 2002, the company notified the FDA of plans to introduce 54 different kinds of packages, ranging from chewable tablets to coated pills, packed into bottles, pouches, cartons and blister packs.
In the webcast interview, McEvoy, a marketing expert who rose into Johnson & Johnson’s corporate ranks, called Tylenol “a billion-dollar brand.”
Internally, company officials refer to it simply as “the Brand.”
How the Liver Processes AcetaminophenThe liver uses multiple enzyme systems, known as pathways, to process acetaminophen and remove potentially toxic byproducts produced during metabolism. In the case of an overdose, these pathways become overwhelmed, allowing the byproducts to build up to toxic levels, resulting in damage to the liver.
TwitterFacebook LinkThe first reports of deaths from acetaminophen emerged in the late 1960s.
Researchers subsequently learned that when the drug is broken down in the liver, it produces a potentially toxic byproduct. In an overdose, the liver can no longer safely dispose of the byproduct and can fail in a matter of days, shriveling like a deflated balloon.
The concerns with acetaminophen emerged at a time when the American system for drug oversight was undergoing a sea change. Congress had passed a law in 1962 requiring the FDA to institute more rigorous testing for new drugs and to review the safety and efficacy of those already on the market.
In 1972, as part of the review of existing drugs, the FDA assembled a group of doctors and scientists to assess painkillers, including acetaminophen. Over five years, the panel held 50 meetings, heard from scores of witnesses, and scoured thousands of pages of research – much of it submitted by drug makers themselves.
As the panel’s work was going on, one of the world’s most prestigious medical journals weighed in on acetaminophen. The London-based Lancet declared in a 1975 editorial that if the drug “were discovered today it would not be approved” by British regulators. “It would certainly never be freely available without prescription.”
The journal’s editorial board called the drug’s apparent safety “deceptive.” They pointed out that “not much more than the recommended maximum daily dosage” could cause liver damage and that acetaminophen poisoning was already “one of the commonest causes” of liver failure in Britain. (The drug is known there and in many countries as paracetamol.)
Relatively few cases of acetaminophen poisoning had been documented in the United States. But an American study published in 1975 identified four acetaminophen-related deaths in one year in one city, Denver. The article suggested a reason why so few cases had previously been found: “If you do not look for something you will not diagnose it.”
McNeil dispatched a top official to meet with one of the study’s authors. The company then gave him funding to help develop the acetaminophen antidote.
Two years later, in 1977, the FDA’s expert panel delivered its 1,200-page report on pain relievers.
While the committee found that acetaminophen was generally safe when used as directed, it warned that “some advertising for acetaminophen gives the impression that it is much safer than aspirin.” So the panelists urged the FDA to add a clear, specific warning to the acetaminophen label.
The language the panel suggested: “Do not exceed recommended dosage because severe liver damage may occur.” The panel had only advisory power, but it felt so strongly that it told the FDA the warning was “obligatory.”
Committee members wanted to drive home the potentially devastating consequences of taking too much acetaminophen, said Ninfa Redmond, a toxicologist who served on the panel.
“We felt very strongly the evidence was conclusive,” Redmond said.
If acetaminophen “were discovered today it would not be approved” by British regulators.1975 editorial in The Lancet, a London-based medical journal
TwitterFacebook LinkFor McNeil, the proposed liver warning put a lot at stake. Just the year before, Tylenol had become the No. 1 brand in the over-the-counter pain medication market, according to a company history.
As McNeil prepared its response to the advisory panel’s recommendation, new reports of harm from the drug emerged.
In September 1977, the Annals of Internal Medicine published articles about patients who suffered liver damage after taking acetaminophen for an extended period of time at or slightly above therapeutic doses, underscoring what the Lancet had said about the drug’s narrow margin for error.
That December, McNeil filed a voluminous response to the FDA opposing the recommendation for a liver warning. It’s not known if the individuals who drafted the company’s filing were aware of the journal articles, but the company asserted that people who overdosed were “almost invariably” trying to kill themselves. Indeed, McNeil maintained it had never seen a “documented case” of a person harmed while taking the drug for medical reasons.
A liver warning “is unnecessary and serves only to confuse and frighten the vast majority of consumers who use acetaminophen in a rational and appropriate fashion,” the company concluded. It also wouldn’t help consumers, the company said, because signs of liver damage often don’t emerge until it’s too late to get help.
McNeil raised another objection: The warning would put it at a competitive disadvantage.
What Do You Think?Should American drugmakers have to limit acetaminophen pills sold over-the-counter?
Weigh InShould the FDA require all acetaminophen drugs to carry black box warnings?
Weigh InWho’s most to blame for deaths caused by mixing up Tylenol products for infants and children?
Weigh In LinkBayer, one of the world’s largest aspirin makers, had started running advertisements citing acetaminophen’s potential to harm the liver, based on the advisory panel’s recommendation. “Losses are already in the millions of dollars,” McNeil stated in its submission to the FDA.
Almost a decade would pass without the FDA coming to any decision. While the label advised consumers to seek medical assistance if they overdosed, McNeil was able to sell its drug without warning that it could harm the liver. The agency’s decision was delayed, at least in part, because regulators extended deadlines to review new research.
Redmond called such additional review unnecessary because the basic facts about the drug were well-established. She said she was mystified by regulators’ failure to act on the panel’s recommendation. “It’s very surprising, and it’s sad,” she said. “How many people might have died because of that?”
Finally, in 1988, the FDA announced a “tentative” ruling. The agency agreed a warning was necessary but said there was no need to specify that the drug could injure the liver.
The agency explained that it didn’t want people who were considering suicide to know what an overdose could do. And, it said, liver damage didn’t produce telltale symptoms for several days, when it was often too late for doctors to intervene.
So it mandated a catchall warning: In case of overdose, consumers should seek prompt medical attention “even if you do not notice any signs or symptoms.”
McNeil had won a reprieve from having to put a phrase on its bottles that company officials believed scared off buyers: “severe liver damage.” And the FDA would not return to the issue until many, many years later.
How Much Acetaminophen Are You Taking?Use this tool to find out which of the drugs in your medicine cabinet contains acetaminophen -- and how much. Note: A single dose may be more than the amount shown. For example, one pill might contain 325 mg but the recommended dose might be two pills, or 650 mg. Source: National Library of Medicine
TwitterFacebook LinkAs the FDA’s deliberations over the label crawled on, research began to emerge about the risks of drinking alcohol and taking acetaminophen — and McNeil took steps to counter the research.
As early as the 1970s, an FDA panel had examined whether to put an alcohol warning on the acetaminophen label. In 1978, according to an internal McNeil memo, the company had been “successful in convincing” FDA officials “that such a warning was not indicated.” But the issue had not gone away.
According to a corporate memo from February 1986, McNeil had test-marketed how consumers would interpret different versions of an alcohol warning. No matter how the warning was phrased, consumers reacted negatively: Most respondents concluded that drinkers should reduce or discontinue using Tylenol, even at recommended levels.
The following month, the Annals of Internal Medicine published a study describing alcoholics who developed liver damage after taking “apparently moderate” amounts of acetaminophen.
Two weeks after the article’s publication, a McNeil official issued a memo to Tylenol’s sales force warning representatives to “not initiate discussions with your physicians” about the danger of mixing alcohol and acetaminophen. A senior McNeil official would later testify in a deposition that the issue was controversial and complex. Sales reps, he said, were “not equipped” to discuss it.
Then, in August 1987, a relatively obscure Swedish journal published a study on the dangers of drinking and taking acetaminophen.
Thomas Gates, then McNeil’s medical director, shot off a memo to the chief executive of Johnson & Johnson, the president of McNeil and other top officials, laying out a detailed “plan of action” for “diffusing media interest” in the research and “limiting the extent and duration of the coverage.”
Gates envisioned two possibilities: “Low Level of Publicity (most probable scenario)” and “High Level of Publicity (worst case scenario).” For the latter, Gates suggested a series of responses: a letter-writing campaign to medical societies, doctors, pharmacists and academics; a coordinated public relations response with the FDA; even placing on retainer scientists whose research the company favored.
“If there is another wave of publicity,” Gates warned, “the FDA might be compelled to reconsider the matter and require a specific warning regarding a possible risk of toxicity in chronic alcohol abusers.”
Gates, long retired from McNeil, was too ill to respond to questions, his wife said.
Ultimately, the Swedish study received little attention.
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Gates’ memo summarized cases in the scientific literature over the previous decade that documented acetaminophen’s risk for drinkers. He wrote that 38 “chronic alcoholics” had reportedly suffered liver and/or kidney damage while taking acetaminophen. In just over half the cases, users substantially exceeded dosing limits.
However, there were 18 instances in which they took less than 6 grams a day, not much more than the 4 grams considered safe, Gates noted.
He stressed that “the amount of acetaminophen ingested is open to question since alcoholics are notoriously unreliable informants.”
But “if accurate,” he wrote, the amount of acetaminophen that harmed those 18 patients “bring us uncomfortably close” to the maximum recommended daily dose.
Although McNeil had been preparing for the possibility that the FDA would require an alcohol warning, it took years before the agency publicly grappled with the issue.
In 1993, the FDA convened an advisory panel to look at the risk of mixing alcohol and acetaminophen. Such panels are made up of outside experts. While the FDA does not have to follow their recommendations, it usually does.
McNeil argued against the warning, saying the scientific evidence did not justify it and that it would frighten customers into taking other pain relievers that the company claimed were riskier.
But the panel found that an alcohol warning was warranted. The chairman called the science behind it “unusually strong and well-supported.”
At the same time, McNeil was seeking FDA approval for a new product, extended release Tylenol. Because it was a post-1962 drug, the agency could push for a warning with less red tape. It moved to do so on the new product, raising the possibility that regular Tylenol would have no alcohol warning but that the time-release product would have one.
After the FDA approved extended release Tylenol with an alcohol alert in 1994, McNeil voluntarily added the warning to all Tylenol products.
“After careful deliberation and discussion with the FDA, McNeil has made several label changes to Tylenol over the years — all for the purpose of eliminating potential confusion by consumers and protecting consumer safety,” the company wrote in response to questions. “A label change does not mean that a prior label was inadequate, and in fact label changes are an indication that our medical understanding is evolving.”
Four years after McNeil acted, the FDA required all acetaminophen manufacturers to add an alcohol alert to their products. People who drank three or more alcoholic drinks every day were advised to consult their doctors and were warned that liver damage could occur.
“When a company omits a known danger to them that could hurt people, they’re lying to us. I think that is outrageous.”Antonio Benedi, who had a liver transplant after taking Tylenol, on McNeil, the Johnson & Johnson division that makes the drug
TwitterFacebook LinkThe warning label came too late for Antonio Benedi.
Benedi, who worked as a special assistant to President George H.W. Bush, often drank two or three glasses of wine with dinner. On a Friday in February 1993, just weeks after Bush left office, Benedi came down with the flu. Over the next several days, he said, he took Tylenol, never exceeding the maximum dose.
Benedi said he was careful to read labels. At the time, nothing on his box of Extra Strength Tylenol warned about the risk of drinking or liver damage.
Several nights later, he woke up, confused and incoherent. His wife called an ambulance to rush him to a hospital near their home in the Virginia suburbs of Washington, D.C.
By the time he arrived, Benedi had slipped into a coma. Tests showed his liver enzyme levels were high, a sign of organ damage. He had brain swelling, so doctors drilled a hole in his skull to relieve the pressure.
Antonio Benedi was forced to undergo an emergency liver transplant after just a few days of taking Tylenol. He won an $8.5 million verdict against McNeil, the Johnson & Johnson division that makes the drug. (Torsten Kjellstrand for ProPublica)
TwitterFacebook LinkAfter his third day in a coma, Benedi got a second chance at life. Doctors declared a young man taken to Benedi’s hospital after a motorcycle accident to be brain dead, and Benedi received the man’s liver.
Benedi spent two months in the hospital, more than 200 surgical staples holding his abdomen together in a raw wound that looked like the Mercedes-Benz symbol.
Almost two decades later, he still suffers from those few days of taking Tylenol. To keep his body from rejecting his transplanted liver, he had to take powerful medications that eventually destroyed his kidneys, requiring a kidney transplant.
He sued McNeil. In court, the company argued that a virus had destroyed his liver and that the warnings on Tylenol’s label were adequate. The jury found for Benedi, awarding him an $8.5 million judgment in 1994. To this day, he will have nothing to do with Tylenol — he always tells doctors and nurses not to give him any.
“I have nothing against corporations. They do a lot of good, employ a lot of people,” said Benedi. But “when a company omits a known danger to them that could hurt people, they’re lying to us. I think that is outrageous.”
“McNeil takes acetaminophen overdose very seriously, which is why we have taken significant steps over the years to mitigate the risk.”Statement by McNeil Consumer Healthcare, the maker of Tylenol
TwitterFacebook LinkAs Benedi’s case unfolded, McNeil was pressing ahead with a program dubbed Project Protect to create a safer version of acetaminophen.
But the company kept the program, which has never been reported, confidential. Even when the government specifically asked for scientific information on developing a safer acetaminophen, the company didn’t mention its own research.
The concept of such a drug was not new. The 1975 Lancet editorial had called for the development of a version of acetaminophen that wouldn’t harm the liver. In the United Kingdom, companies had developed drugs combining acetaminophen with one of its antidotes. But sales never took off — the drugs were too expensive, the pills were too large, and there were questions about the drugs’ safety.
In the early 1990s, McNeil embarked on a series of experiments to combine acetaminophen with various protective agents. The effort involved almost 20 different lab and animal studies lasting several years, according to internal company documents and court records.
As the experiments progressed, however, one official worried that the research could be a double-edged sword.
A Johnson & Johnson manager based in Europe wrote to Ralph Levi, the head of Project Protect for McNeil, according to court documents. In his June 1994 note, the manager cautioned that a new, improved product touched on “a sensitive point,” because the company would be acknowledging that its existing product “isn’t so safe as we’ve always said before.” Levi has since died, and the court documents identified the manager only by his first name, Geert.
To help keep Project Protect hidden, the company signed a confidentiality agreement with Rutgers University, where some of the research was conducted. A key clause: The publicly funded university agreed not to publicize “the identity or interest of McNeil in this area of technology.” Rutgers said such agreements were standard when researchers worked with companies.
At least one line of research showed early promise, according to Rutgers documents, but there’s no public evidence that it or any Project Protect compound made it beyond laboratory or animal studies.
Have you or someone you know experienced acetaminophen poisoning - by accident or on purpose?About 160 Americans die accidentally each year from acetaminophen poisoning — and about the same number use the drug to commit suicides each year. ProPublica is seeking stories of those who have been harmed.
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McNeil’s work remained confidential even after the FDA became interested in that field of research. In 2006, as part of a larger review of acetaminophen, the agency solicited information about combining the drug with antidotes.
In response, McNeil submitted a lengthy report citing 51 studies to document the drawbacks of such combinations. But the company did not mention that it had extensively researched the topic.
FDA officials said McNeil wasn’t required to disclose its research in that response. Asked if the company had ever told the agency of its project, the FDA did not answer. “Those are the kind of things that we are always interested in knowing about,” said Kweder, the FDA’s acetaminophen expert. She added that even “if they didn’t show anything, it’d be useful to us to know if didn’t work scientifically.”
In response to questions about Project Protect, McNeil acknowledged "research into acetaminophen overdose antidotes" but did not provide details. The company noted that confidentiality clauses are standard industry practice. It also said that the firm had complied fully with FDA reporting requirements.
The company said it halted the research after discovering that the most promising agent “posed a cardiovascular risk for individuals with a particular genetic defect.” The company did not disclose the name of the agent.
“Had the research yielded a viable discovery, our intention was to launch a product,” the company statement said. It continued: “Despite the outcome, we consider this type of research a responsible action on our part, and are proud of the many scientists who worked on it.”
“It’s just like candy. If four is good, eight must be better.”Dr. Will Lee, a professor of internal medicine at the University of Texas Southwestern Medical Center whose research has shown that acetaminophen is the leading cause of acute liver failure in the U.S., on the drug
LinkAs McNeil quietly pursued a safer acetaminophen, a bespectacled, bow-tied Dallas doctor named Will Lee was pursuing research that would change the debate about the drug.
In 1997, Lee published a groundbreaking paper in the New England Journal of Medicine showing that acetaminophen was the leading cause of acute liver failure at Parkland Memorial hospital in Dallas, despite the drug’s “apparent overall safety.”
Not to be confused with chronic liver failure, such as that caused by alcoholism, acute liver failure is a sudden, often fatal condition that affects about 2,000 Americans each year.
Among 21 patients who had overdosed on acetaminophen accidentally, Lee found, three reported that they had not exceeded the maximum recommended dose of 4 grams per day. Only seven said they had taken more than 10 grams.
Following the article, the National Institutes of Health funded a larger study involving many of the country’s busiest liver transplant centers. Over the next 15 years, Lee, who is currently a professor of internal medicine at the University of Texas Southwestern Medical Center, confirmed that what he had documented in Dallas was true nationwide: Acetaminophen was the No. 1 cause of acute liver failure.
Over the years, almost half of the people in the study had overdosed by accident, Lee found, not by trying to kill themselves. Many of those patients had other risk factors; about one-fifth drank alcohol frequently.
One finding was downright counterintuitive: People trying to kill themselves with massive, one-time overdoses were more likely to survive than those who accidentally took too much.
The reason? The chemical antidote to acetaminophen poisoning that McNeil helped to develop has a high success rate if administered within eight hours of an overdose. Those who attempted suicide and later regretted their action often made it to a hospital in time.
The Phases of Acetaminophen PoisoningPeople who overdose on acetaminophen don't always realize they have been poisoned. Here are symptoms of poisoning over the course of several days.
TwitterFacebook LinkSources: U.S. Food and Drug Administration; National Institutes of Health; Medscape.com; Dr. Paul Watkins, University of North Carolina
Graphic by Al Granberg
Those who overdosed by accident were often unaware they had been poisoned. Their symptoms took several days to develop and resembled those of the flu, for which many of them had taken the drug in the first place. They were more likely to miss the window for the antidote.
Acetaminophen has “not been recognized as a poison — that’s been part of the challenge,” Lee said. “It’s just like candy. If four is good, eight must be better.”
McNeil disputed Lee’s findings, saying they had “serious methodological weaknesses,” such as relying upon patients to recall the amount of acetaminophen consumed.
But other researchers came to similar findings. At the Hospital of the University of Pennsylvania, Dr. Sarah Erush and a colleague found that half of 46 patients treated for acetaminophen-related liver damage over four years had overdosed accidentally, not intentionally.
The amount of acetaminophen these patients had ingested was close to the recommended daily dose of 4 grams. The median was 6 grams per day — a surprise, because the toxic dose was thought to be between 10 and 15 grams, Erush said. She also found that most of these patients had other risk factors, such as chronic alcohol use.
Although she didn’t publish her research in a peer-reviewed journal, she presented it to the FDA.
“For almost every patient with accidental exposure, we said, ‘Why did you take more than the recommended dose?’” Erush said in an interview. “They said two things: One, the label wasn’t clear, and, two, they always thought it was a perfectly safe drug.”
McNeil said that it had asked Lee and Erush for patient information in order to examine their conclusions. Both researchers said they had not provided McNeil such records, citing patient privacy issues.
Lee’s research spurred the FDA to re-examine if the label on over-the-counter acetaminophen should explicitly warn about the risk of liver damage.
The agency invited a grieving mother to tell her story at a public hearing.
Kate Trunk’s 23-year-old son Marcus had hurt his wrist in 1995 while working on a construction job in Pennsylvania. Over the next two weeks, he took Tylenol with Codeine and Extra Strength Tylenol. He started to feel sick and started on Theraflu — apparently not realizing that it, too, contained acetaminophen.
Soon, Marcus felt bad enough to check himself into a hospital, where he lapsed into a coma. Eight days after Marcus entered the hospital, Kate and her husband decided to end life support.
“We stayed with him and held him and talked to him and kissed him and petted him,” Trunk said. “He finally just went. It was total shock, walking around in a daze, not knowing, angry at God, angry at everything.”
The mystified family did not find out the cause of Marcus’ death until the autopsy came back: liver failure caused by acetaminophen. The Trunks sued McNeil and settled for an undisclosed amount. McNeil did not respond to questions about the case.
When the Trunks took their concerns to the FDA hearing, Kate was so nervous that her husband kept checking her blood pressure. But she delivered a call to action: She wanted acetaminophen clearly labeled to warn that the drug could poison and even kill.
“Death is not an acceptable side effect.”Kate Trunk, who lost her son to liver failure caused by acetaminophen, speaking before the FDA
TwitterFacebook Link“If our son or my husband and I even had an inkling that acetaminophen toxicity existed, I feel that the outcome of our story would be totally different,” she said. She ended her testimony by saying that “death is not an acceptable side effect.”
The committee recommended adding a warning aimed at all users, not just drinkers, that overdosing can damage the liver.
This time, McNeil gave ground, agreeing with the need for a liver warning. “We believe with you that the American consumer is smart, responsible and can self-manage medications,” Dr. Debra Bowen, McNeil’s vice president of research and development, told the panel.
By 2005, McNeil began placing labels on Tylenol warning that taking too much could result in “liver damage” for anyone, not just people who drank alcohol.
In 2009, the FDA imposed stronger language, requiring all over-the-counter acetaminophen products to warn that overdosing may cause “severe liver damage.”
The FDA’s wording was nearly identical to what its expert panel had recommended 32 years earlier.
Asked about this time lag, the agency replied, “While we acknowledge that there has been some delay between available scientific information and the translation to labeling instructions for consumers, FDA has strengthened warnings on the acetaminophen label accordingly as science has evolved.”
The FDA's 2004 public service announcement. (FDA)
While McNeil agreed on the need to warn consumers of acetaminophen’s potential to harm the liver, it vigorously objected to the FDA’s plans to raise public awareness of that very risk.
In 2004, the agency launched a modest public service advertisement initiative. The slogan: “Why is it important to know that all these medicines contain acetaminophen? Because too much can damage your liver.”
A key problem the campaign hoped to address: double dipping, or overdosing by inadvertently taking more than one medication that contains acetaminophen.
That risk had grown as McNeil and its competitors expanded the number of acetaminophen products on drugstore shelves. The drug was in medications targeted at consumers suffering all manner of ills, from colds to arthritis aches to insomnia caused by pain.
The FDA didn’t have a lot of money for the 2004 campaign, just $20,000, according to an Associated Press story from the time.
During this period, McNeil was spending more than $100 million a year to advertise Tylenol, trade publications reported.
Nevertheless, McNeil launched an intense and lengthy effort to overhaul the campaign.
The company sent a 79-page complaint demanding that, if left unchanged, the FDA’s educational campaign would “negatively affect McNeil, the world’s largest marketer of OTC acetaminophen products.”
Indeed, the complaint said, the FDA should speed up its review “in order to limit the damage that is being done” by the nascent campaign.
McNeil wanted the FDA to include warnings about other over-the-counter pain relievers, arguing that they posed risks at least as serious as acetaminophen. The FDA’s initiative, the company contended, created the false impression that “acetaminophen products are less safe” than other over-the-counter painkillers and could spur consumers to switch to other pain medicines, resulting in more injuries and deaths – a frequent McNeil argument.
The FDA’s Steven Galson, then the acting director of the agency’s Center for Drug Evaluation and Research, disagreed.
Doubling the maximum daily dose of over-the-counter pain killers such as aspirin or ibuprofen “may slightly increase a person’s risk for bleeding,” in the stomach and gastrointestinal tract, he wrote, but “it is not even close to the seriousness presented by doubling the dose of acetaminophen,” which can lead to liver failure.
McNeil took its case all the way to the FDA commissioner, who turned down the company’s final appeal, saying the agency had “refuted each example to respond to your allegation.”
McNeil did not respond directly to questions about its opposition to the campaign. But it stressed that it had launched numerous acetaminophen safety education efforts, both on its own and with industry and government partners. Altogether, McNeil said, these “acetaminophen awareness messages have been seen over one billion times.”
Although the agency had prevailed, its safety initiative fizzled. Major media outlets were reluctant to run the public health announcements. Magazine publishers told agency officials that they “did not want to antagonize potential advertisers,” according to an FDA report.
The FDA concluded that its campaign “did not appear to have a significant impact on the problem.”
Indeed, a nationwide poll this year shows that many Americans don’t recognize the risk of double dipping.
Thirty-five percent of respondents said it was safe to take the maximum recommended dose of Extra Strength Tylenol with NyQuil, a cold remedy that also contains acetaminophen. The margin of error was 3.5 percentage points.
Among parents, 35 percent thought it was safe to give a child the maximum dose of Children’s Tylenol with Children’s Tylenol Plus Multi-Symptom Cold, both of which contain acetaminophen. The margin of error for the parents’ subgroup was 6.7 percentage points.
In both these examples, mixing the two medicines would not be safe, according to the FDA.
(The survey of 1,003 respondents – conducted by Princeton Survey Research Associates International and commissioned by ProPublica and This American Life – was completed in March.)
What’s in a Dose?You may be familiar with some of these over-the-counter and prescription drugs, and may have even taken more than one at the same time. Because so many drugs contain acetaminophen, people can inadvertently take more than the recommended daily limit – or even hit a dangerous dose. Click on a drug to see the maximum daily dose recommended on the label, and how quickly it adds up in combination with others. Click on the drug again to remove it from the acetaminophen tally. Please note: This is not meant to be medical advice. Toxic levels vary by individual. Call your doctor if you think you’ve overdosed, even if you don’t show medical symptoms. Source: National Library of Medicine
Excedrin®Excedrin® 2000mg
Nyquil®Nyquil® 2600mg
Robitussin®Robitussin® 3840mg
Sudafed®Sudafed® 3250mg
Alka-Seltzer®Alka-Seltzer® 2000mg
Theraflu®Theraflu® 3900mg
Extra Strength Tylenol®Extra Strength Tylenol® 3000mg
Zicam®Zicam® 3900mg
Anacin®Anacin® 4000mg
Childrens Tylenol®Childrens Tylenol® 800mg
Dimetapp®Dimetapp® 800mg
Panadol®Panadol® 800mg
Dayquil®Dayquil® 1300mg
Coricidin®Coricidin® 3900mg
Tylenol® w/ CodeineTylenol® w/ Codeine 4000mg
Vicodin®Vicodin® 3960mg
Percocet®Percocet® 3900mg
Hydro-codone BitartrateHydro-codone Bitartrate 3900mg
OxycodoneOxycodone 3900mg
Ultracet®Ultracet® 2600mg
Click on a drug to see its daily limit of acetaminophen
TOTAL
milligrams
TwitterFacebookLinkWith the public education campaign faltering, the FDA regrouped in 2006 and convened a team to examine the agency’s handling of acetaminophen — including what a former top official described as “the interactions between the FDA and McNeil over this 30-year history.”
Officials reviewed the science, the reports of deaths and side effects, and the long history of regulatory delays. The 265-page report that emerged was both a blunt assessment of the drug’s dangers and a plan for mitigating them.
Officials concluded that deaths from acetaminophen poisoning had risen dramatically over the decade between 1995 and 2005. They zeroed in on how the drug differed from other over-the-counter pain relievers.
“The 4 gram per day recommended dose is also the maximum safe dose, one that must not be exceeded, an unusual situation for any drug, particularly an OTC drug, one placing a large fraction of users close to a toxic dose in the ordinary course of use,” the report said.
Officials proposed more than a dozen solutions, including several aimed at widening the drug’s safety margin, such as lowering the maximum recommended daily dose and reducing the amount of the drug in each pill. The report also suggested removing an entire class of pediatric products to reduce the potential for dosing mix-ups.
Taken together, the proposals constituted a blueprint for sweeping safety reforms.
At the same time, the FDA officials who wrote the report gave a candid assessment of the fierce resistance they expected from drug makers to certain proposals.
To the notion of lowering the recommended daily dose, the agency expected a “possible industry challenge.”
To the proposal to decrease the amount of acetaminophen per pill, the report anticipated “possible industry resistance to costs related to reformulation” and to “possible loss of revenue from elimination of 500 mg products.”
In June 2009, the agency gathered nearly 40 experts in a Maryland Marriott to weigh in on its recommendations. Everyone in the room, including executives from McNeil and other companies, knew the stakes.
Guides to Safe UseHere are some sites that offer information on how to safely use acetaminophen. ProPublica does not endorse any of these sites and is not offering medical advice. If you have a medical issue, contact a doctor.
Consumer Health Products Association and others
LinkEdwin Kuffner, McNeil’s medical director, had prepared for the meeting by attending some 100 practice sessions with a consulting company that specialized in readying corporate clients to speak before the FDA, according to a court deposition.
Kuffner objected to dropping the daily recommended dose below 4 grams. For decades, the company’s labels had advised users to take no more than 1 gram, or the equivalent of two Extra Strength Tylenol pills, at a time. He suggested directing consumers to take one pill at a time until they felt pain relief, gradually easing up to a maximum of 4 grams a day only as necessary. Even though a company document calls this practice “good medicine,” McNeil has not added this instruction to Tylenol labels.
When it came time to vote, Judith Kramer, a physician and professor of medicine at Duke University, reminded her fellow panelists of the opportunity before them, noting that attempts to make acetaminophen safer had foundered for decades.
“There is an elephant in the room that we really should talk about explicitly,” she said. “There are tremendous cost and commercial implications to some of the recommended changes. These conditions frequently can overshadow the public health considerations. And I think that we can't let that happen.”
The panel handed McNeil a defeat, endorsing most of the FDA’s proposals.
But then, the agency’s momentum stalled.
Four years later, the agency has not enacted any of its own suggestions for over-the-counter acetaminophen.
In fact, the FDA has still not completed the review of the drug that began back in the 1970s, as part of the agency’s larger mandate to assess the safety and efficacy of older medicines.
In interviews, FDA officials acknowledged that it has taken longer than it should. They blamed a combination of science and bureaucracy.
Despite 50 years of sales and more than 30,000 published papers, there remain unknowns about acetaminophen. In a little-publicized 2011 announcement, the FDA acknowledged it was still unable “to identify precise toxic thresholds and/or specific populations for whom currently recommended dosages are not safe.”
A Canadian government study found six people had suffered serious liver damage after taking less than the maximum recommended dose. By contrast, a case report described a man who survived after ingesting as much as 60 grams all at once. In response to questions, McNeil first wrote in an email that 8 grams, or double the maximum daily dose, over several days can damage the liver. Later, when asked to confirm this figure, the company declined to do so. It pointed to data showing that at least 10 grams a day for at least 2 to 3 days can threaten the liver.
Setting the right dose “has been one of the big challenges for us,” the FDA’s Kweder said. “There is so much disagreement among experts who are well respected and can present data on where they’d draw that line.”
Agency officials also said that McNeil has often resisted changes.
McNeil was “more aggressive than most,” a former top FDA official said. “It’s a company that feels very strongly about the competitive nature of the marketplace.”
McNeil countered: “Our marketing practices are appropriate and align with the regulatory standards for our industry.”
It also added that the company had a “deep respect for the Food and Drug Administration (FDA) and its role in establishing and enforcing regulations” and noted that it has voluntarily implemented some safety measures before the agency required it to do so.
The FDA delays are, at least in part, self-inflicted.
The agency said that the procedure it set back in the 1970s for revising rules for older drugs "was not rapid, but there were many fewer steps to the process that today is long." Indeed, actions that were supposed to take months have dragged on for years or even decades.
For prescription drugs, the FDA can act more swiftly, and it has limited the amount of acetaminophen in such medicines.
In 2011, the FDA limited the amount of acetaminophen that can be put in prescription drugs to 325 milligrams per pill, and gave companies until January 2014 to implement the change.
Yet the agency continues to allow the sale of over-the-counter pills that contain up to 650 milligrams of acetaminophen — twice as much.
Asked why it permits such potent pills to be sold directly to consumers, an FDA official said the agency “believes there is a benefit to having acetaminophen available.”
In addition to lowering the dose per pill, the FDA slapped prescription acetaminophen with a so-called black box warning, the agency’s most serious. It states that “acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.”
The label for the over-the-counter version of the drug, taken by far more Americans, mentions neither of those potential consequences.
The agency’s disparate actions on prescription and over-the-counter acetaminophen have given rise to glaring inconsistencies.
Tylenol with Codeine No. 3, made by a Johnson & Johnson company, combines acetaminophen with codeine, which can be bought only with a prescription. Tylenol 3, as it is commonly known, carries a black box warning about acetaminophen, and each pill contains 300 milligrams, less than the new limit of 325 milligrams.
By contrast, a single pill of Extra Strength Tylenol — sold at newsstands, gas stations and big-box retailers across the land — delivers 500 milligrams of acetaminophen. The bottle carries no black box warning.
Two pills, containing the same medication, made by the same corporation, carrying the same brand name, regulated by the same agency – but subject to different standards.
While the FDA remains stuck on rules for over-the-counter acetaminophen, McNeil has reversed course on one major proposal.
Just a month after adamantly opposing dosing reductions at the 2009 advisory committee meeting, McNeil wrote top FDA officials, offering a plan that recognized the will of the advisory committee.
Although the company had insisted for half a century that 4 grams of medicine per day was the most appropriate dose for pain relief, the company said it was ready to recommend taking no more than 3 grams a day (or six pills) of its flagship product, Extra Strength Tylenol. The company implemented the change in 2011.
The move echoed other instances, such as the alcohol warning, in which the company opposed safety proposals until the FDA signaled its intent. Then the company adopted measures voluntarily as the agency plodded toward final rules.
“There are still many questions about this drug... It's still killing people.”Dr. Thomas Garvey, a former FDA official and drug industry consultant on acetaminophen. He has testified against McNeil, the manufacturer of Tylenol.
TwitterFacebookLinkKuffner, McNeil's vice president for medical affairs, said in an interview that the company changed its dosing instructions “after hearing the discussion” at the 2009 advisory committee. The lower dose is “intended to increase the margin of safety,” he said.
McNeil hasn’t standardized the new daily dose across all its products, however. For Tylenol Arthritis Pain, the company’s label puts the daily limit at 3.9 grams. And the company didn’t change the dose for customers worldwide. In Canada and other countries, the company still instructs users of Extra Strength Tylenol that they can take up to 4 grams a day — eight pills.
Kuffner said the “root causes” of acetaminophen overdose differ from region to region.
“The safety of consumers in every region is important to us. When you really go back and look at root causes, some of the root causes weren’t as prevalent as in other regions,” he said. “There are differences in the prevalence of acetaminophen overdose and liver injury.”
“At the end of the day, when people take 4 grams or 3 grams, both of them are safe doses,” Kuffner said.
The FDA had said it would issue proposed rules for over-the-counter acetaminophen by the end of August. But the agency missed that deadline, pushing it back to December.
Dr. Thomas Garvey, a former FDA official and drug industry consultant who has testified against McNeil in trials, called the amount of time the FDA had taken to reach a final ruling “remarkable and unusual.”
“There are still many questions about this drug,” Garvey said. “It’s still killing people.”
Many countries restrict sales of acetaminophen, the active ingredient in Tylenol. Countries such as South Korea, the United Kingdom and Germany limit the amount of pills that can be sold in a package or where it can be sold. (Lars Klove for ProPublica)
In many other countries, authorities have taken a very different approach to regulating acetaminophen.
At least 10 other industrialized countries — including Australia, New Zealand, Germany, Finland, Denmark, Sweden and Switzerland — have placed some kind of restrictions on the drug, a 2008 FDA report said. Most limit how much can be sold at one time or require pharmacies to be the only outlets that carry it.
Some European countries with strict regulations have remarkably few deaths. Switzerland’s national toxicology center reported only four deaths due to acetaminophen poisoning from 1998 through 2012. Even accounting for Switzerland’s much smaller population, that’s a fraction of the U.S. toll.
The German government reported four deaths from acetaminophen poisoning in 2010, the same year the CDC put the American total at 321. The U.S. population is four times that of Germany.
Both Switzerland and Germany limit sales to pharmacies, which sell packages with a maximum of 10 grams, the equivalent of 20 Extra Strength Tylenol pills.
In many nations, authorities were focused more on reducing suicides than on preventing accidental overdoses. In the U.K., for example, acetaminophen had become a common suicide method by the 1990s. The drug was easy to get: In drug stores, it could be purchased in unlimited quantities.
In 1998, the U.K. cracked down on several types of pain relievers, including acetaminophen. At pharmacies, people could buy the equivalent of only 32 Extra Strength Tylenol pills. At other stores, they were limited to half that.
Acetaminophen Around the WorldSee how much acetaminophen you can buy in the United States compared to England, Germany, and Mexico. Each jar contains the maximum amount of acetaminophen allowed in a single package. Each gram is the equivalent of two Extra Strength Tylenol tablets.
The United StatesUnlimited
(we found 500 grams)
16 grams
Germany10 grams
Mexico10 grams
PHOTO: LARS KLOVE FOR PROPUBLICA TwitterFacebookLinkHere was a real-world experiment of the effect of restricting acetaminophen. Early studies were somewhat contradictory, but this year, a large study concluded that the number of deaths linked to acetaminophen had plunged by 43 percent. In the 11 years since the restrictions took effect, the researchers estimated, 765 fewer people had committed suicide using the drug.
While the new regulations may have saved lives, they hurt sales. The amount of acetaminophen sold in the U.K. plunged by 60 percent from 1998 to 2000, according to a study by the FDA. The agency noted that such restrictions would be more difficult to implement in the U.S. because it has a different commercial, regulatory and medical culture than Britain and many European countries.
Indeed, here there has been only limited debate about restricting the amount of acetaminophen consumers can buy.
A proposal to limit package sizes — how many pills could be put in a bottle, for example — was considered by the advisory panel convened by the FDA in 2009. In a close vote, it failed. Some of the experts worried that patients suffering from arthritis would be inconvenienced by having to make repeated trips to buy the drug.
Several committee members said they had struggled with their vote.
“I hope the FDA doesn't consider this ‘no’ vote to mean that we support selling 1,000 acetaminophen tablets in Costco,” said Kramer, the Duke University professor.
Over the past several years, McNeil and Tylenol have suffered a series of body blows related not to acetaminophen’s risks but to the company’s ability to manufacture its drugs safely. The headlines might have killed a lesser product, but have only underscored the extraordinary resiliency of the Brand.
Between 2008 and 2010, federal regulators discovered an array of troubling manufacturing violations at McNeil’s plants, triggering a series of recalls of Tylenol and other products such as the company’s Motrin brand of ibuprofen.
For example, to make Tylenol syrup for infants and children, the company used an ingredient that was possibly contaminated by dangerous bacteria. The company said “a thorough investigation” showed the bacteria had not reached its medicine. However, the FDA found that McNeil’s tests — skimming a teaspoon off the top of a container of liquid — were inadequate.
Later, agency investigators also discovered that Tylenol and other products had been contaminated by tiny bits of cadmium, nickel, chromium, iron and other metals, most likely shavings that fell into the medicine from machines on the production line.
Again, McNeil officials saw little cause for concern. “We are talking minute particles,” one McNeil employee told FDA officials. “We are talking contaminants you don’t want to be there!” an inspector replied, according to previously unreported notes taken by McNeil.
The company itself determined that it had manufactured batches of what the FDA called “super potent” Infants’ Tylenol with up to 23 percent more acetaminophen than was supposed to be in it. It is not known if any reached the market.
On April 30, 2010, the FDA issued a formal inspection report with a litany of deficiencies. The same day, McNeil pulled 136 million bottles of pediatric Tylenol and other medicines off the market.
It was the largest recall in the history of pediatric medicine.
Subsequently, the Department of Justice launched a civil investigation that effectively gave the FDA power to direct the cleanup of McNeil’s troubled plant in Fort Washington, Pa. The FDA has not tied any recalled product to individual cases of harm.
Congress hauled in company executives for two public hearings. William C. Weldon, then chairman and chief executive of Johnson & Johnson, told lawmakers the company had “let the public down” by not maintaining high quality control standards.
“We are working hard to restore the public’s trust and confidence in Johnson & Johnson and to strive to ensure that something like this never happens, ever again,” Weldon said.
By the end of 2010, the recalls had cost McNeil approximately $900 million in sales, it reported. Many Tylenol products vanished from the shelves for months. The company recently acknowledged that it faces federal investigations related to the recalls; it said it is cooperating with the probes. The company’s Fort Washington plant remains closed.
Meanwhile, McNeil has faced new court challenges about the risks of its billion-dollar brand.
In the past few years, about 100 lawsuits have been filed, contending that McNeil has failed to adequately warn the public about the true danger of Tylenol. Most of the lawsuits have been consolidated before a federal judge in Philadelphia. McNeil is fighting the claims, saying its warnings were adequate. Many of the cases allege that consumers suffered injury or death after taking Tylenol at or near the maximum recommended daily dose.
After enduring all the negative headlines about its manufacturing plant, getting hit with scores of lawsuits, and even being removed from some markets for months, Tylenol retains its power as a brand — a testament to the decades of skillful marketing.
In Johnson & Johnson’s July earnings call, top officials said McNeil’s over-the-counter revenue had surged by 26 percent. Children’s Tylenol was one of the top two brands in over-the-counter pediatric pain relief.
And the company’s flagship product? Extra Strength Tylenol had doubled its market share in the first half of 2013.
Once again, it was America’s No. 1 over-the-counter adult pain medicine.
Additional reporting by Jannis Brühl, Cora Currier, Liz Day, Sergio Hernandez, Olga Pierce, Hanna Trudo
Related:Brianna's Story: "She Didn't Have a Second Christmas"
The Phases Of Acetaminophen PoisoningPeople who overdose on acetaminophen don't always realize they have been poisoned. Here are symptoms of poisoning over the course of several days.
1
0-24 hours
Patient may exhibit sweating, nausea and vomiting, after taking the overdose. Blood levels of enzymes, associated with liver damage, begin to rise. Later on, the symptoms often subside and the patient may feel better. However, the enzyme levels continue to rise along with possible liver damage.2
18-72 hours
The symptoms of abdominal pain, nausea and vomiting return. Blood tests confirm very high levels of enzymes associated with liver damage.3
72-96 hours
As the liver fails, jaundice sets in, turning the skin and eyes yellow. Poisons accumulate in the blood, and the kidneys fail. Doctors must decide whether to attempt a liver transplant. Lucky patients survive with a fully recovered liver. Others survive after a liver transplant.4
96 hours+
However, some patients die from liver failure.Sources: U.S. Food and Drug Administration; National Institutes of Health; Medscape.com; Dr. Paul Watkins, University of North Carolina
Graphic by Al Granberg
TwitterFacebook Link var disqus_shortname = 'propublica'; (function() { var dsq = document.createElement('script'); dsq.type = 'text/javascript'; dsq.async = true; dsq.src = '//' + disqus_shortname + '.disqus.com/embed.js'; (document.getElementsByTagName('head')[0] || document.getElementsByTagName('body')[0]).appendChild(dsq); })(); Please enable JavaScript to view the comments powered by Disqus. blog comments powered by Disqus // phases of acetaminophen poisoning chart propublica.views.timeLapseGraphic = propublica.View.extend({ id : "timelapse_graphic", render : function() { if ($(window).width() > 768){ _.bindAll(this, "stick"); $(window).scroll(this.stick); var clock = $("img.clock") var item = $(".timelapse_item") var line = $("#timelapse_line") var startScroll = $("#poisoning-graphic-scroll").position().top var stopScroll = startScroll +600 var scrollInterval = 50 var height = this.el.height() -40 clock.attr("data-"+(startScroll), "top:125px") clock.attr("data-"+(stopScroll), "top:775px") line.attr("data-"+startScroll, "height:0px;") line.attr("data-"+stopScroll, "height:600px;") item.each(function() { var itemNum = $(this).attr("data-item") var itemStart = (startScroll + (scrollInterval*itemNum) +50) var itemStop = itemStart + 200 $(this).attr("data-"+itemStart, "opacity:0;") $(this).attr("data-"+itemStop, "opacity:1;") }); } }, stick : function() { var startTop = $("#poisoning-graphic-scroll").position().top var windowTop = $(window).scrollTop() if (windowTop > startTop && windowTop < startTop+500) { this.el.css("top","0px").css("position","fixed").fadeIn(800) } else if (windowTop > startTop+500) { this.el.css("top",startTop-300).css("position","absolute") } else if (windowTop < startTop){ this.el.hide() } }, }); propublica.models.doseMeter = propublica.Model.extend({ setNum : function(it) { this.curNum = it; }, }) var doseMeter = new propublica.models.doseMeter(); // doseMeter.setNum(windowPlace) // doseMeter.curNum //Overdose-o-meter graphic propublica.views.overdoseOMeter = propublica.View.extend({ tag : "", cssClass : "overdose_chart_item", bindings : { click : "calculateDose", mouseenter : "showOverlay", mouseleave : "hideOverlay" }, calculateDose : function(e) { function removeCommas(str) { return(str.replace(/,/g,'')); } if ($(window).width() > 768){ var cur = $(e.currentTarget); var total = $(".total_box .total span"); var prev = doseMeter.curNum || 0 var curNum = parseInt(cur.attr("data-num")); var index = cur.index() var name = cur.children(".h4").text(); var quantity = $(".quantity"); $(".total_box .total").fadeIn("fast"); $(".total_box .no_total").hide(); // this whole mess is to make sure when you click on a label the overlay goes away, even though your mouse is hovered over it.. this.el.removeClass("nohover") if (cur.hasClass("selected")) { cur.removeClass("selected") cur.addClass("nohover") } else { cur.addClass("selected") }; var commaDelimit = function(number) { return _.isNumber(number) ? number.toString().replace(/(\d)(?=(\d\d\d)+(?!\d))/g, "\$1,") : ""; }; doseMeter.setNum(Math.round(prev)+Math.round(curNum)) total.text(doseMeter.curNum) var curTotal = parseInt(doseMeter.curNum) if (cur.hasClass('selected')){ $(".indv").prepend(""+ name+" "+ curNum+" mg") } else { $(".idx-"+index).remove() doseMeter.setNum(prev-curNum) total.text(doseMeter.curNum) if (doseMeter.curNum < 15000) { $(".deadyet").html("") } } if ($(".indv").position().top < 0) { $(".idx-"+index).hide() } else { $(".indv div").show() } if (doseMeter.curNum/34.88 < 16000) { quantity.css("height",(doseMeter.curNum/34.88)+"px") } // now we figure out the appropriate text and the color of the total based on the newly calculated total milligrams var newTotal = doseMeter.curNum; if (newTotal == 4000) { total.removeClass() total.addClass("daily_max") $(".deadyet").html("You've reached the FDA’s recommended maximum daily limit of acetaminophen.") $("#overdose_chart div").css("pointer-events","all") } else if ((newTotal > 4000) && (newTotal < 8000)) { total.removeClass() total.addClass("daily_max") $(".deadyet").html("You've exceeded the FDA’s recommended maximum daily limit of acetaminophen.") $("#overdose_chart div").css("pointer-events","all") } else if (newTotal == 8000) { total.removeClass() total.addClass("double_max") $(".deadyet").html("You've reached the amount at which liver damage can occur if taken for several days, according to McNeil, the maker of Tylenol.") $("#overdose_chart div").css("pointer-events","all") } else if ((newTotal >= 8000) && (newTotal < 15000)) { total.removeClass() total.addClass("double_max") $(".deadyet").html("You've exceeded the level at which liver damage can occur if taken for several days, according to McNeil, the maker of Tylenol.") $("#overdose_chart div").css("pointer-events","all") } else if (newTotal == 15000) { total.removeClass() total.addClass("dead") $(".deadyet").html("You've reached the threshold toxic dose of acetaminophen. A single dose at this level can result in death, according to medical experts and literature.") $("#overdose_chart div").css("pointer-events","all") } else if (newTotal > 15000) { total.removeClass() total.addClass("dead") $("#overdose_chart div").not(".selected").css("pointer-events","none") $(".deadyet").html("You've exceeded the threshold toxic dose of acetaminophen. A single dose at this level can result in death, according to medical experts and literature.") } else if ((newTotal < 4000) && (newTotal >0)) { total.removeClass(); $(".deadyet").html("") $("#overdose_chart div").css("pointer-events","all") } else if (newTotal ==0) { total.removeClass(); $(".deadyet").html("") $(".total_box .total").hide() $(".total_box .no_total").fadeIn("fast"); $("#overdose_chart div").css("pointer-events","all") } total.text(commaDelimit(doseMeter.curNum)) } }, showOverlay : function(e) { $("#overdose_chart div").removeClass("nohover"); var cur = $(e.currentTarget); cur.addClass("hover"); }, hideOverlay : function(e) { $("#overdose_chart div").removeClass("hover"); }, }); // slideshow javascript propublica.views.tySlideShowNext = propublica.View.extend({ cssClass : "slideshow_next", tag : "span", bindings : { click : "slideNext" }, getListener : function(cur) { ary = cur.parents("[data-listener]").data("listener").slice(0); ary.unshift("Tylenol Main"); ary.push("PrevNext"); return ary; }, render : function() { if ($(window).width() < 481) { this.OFFSET = 320; this.itemsOnScreen = 1; } else if ($(window).width() < 800) { this.OFFSET = 640; this.itemsOnScreen = 2; } else { this.OFFSET = 960; this.itemsOnScreen = 3; } _.bindAll(this, 'slideNext'); this.slider = $(".slideshow_box_container"); this.boxCt = this.slider.children(".embed_box").length; this.maxScreens = Math.ceil(this.boxCt / this.itemsOnScreen); propublica.tySlideScreen = (propublica.tySlideScreen || 0); }, slideNext : function(e) { var that = this; if (propublica.tySlideScreen >= (this.maxScreens - 1)) { // can't go forward return; } this.track.apply(this, this.getListener($(e.currentTarget))) $(".slideshow_nav").removeClass("inactive"); propublica.tySlideScreen++; this.slider.animate({ marginLeft : "-=" + this.OFFSET }, 1000, function() { // if we're on the last page, // disable forward button if (propublica.tySlideScreen >= (that.maxScreens - 1)) { that.el.addClass("inactive"); } }) } }) $('iframe').bind('mousewheel', function (e) { $(this).scrollTop($(this).scrollTop() - e.originalEvent.wheelDeltaY); //prevent page fom scrolling return false; }); propublica.views.tySlideShowPrev = propublica.views.tySlideShowNext.extend({ cssClass : "slideshow_prev", tag : "span", bindings : { click : "slidePrev" }, slidePrev : function(e) { var that = this; if (propublica.tySlideScreen <= 0) { // can't go back return; } this.track.apply(this, this.getListener($(e.currentTarget))) $(".slideshow_nav").removeClass("inactive"); propublica.tySlideScreen--; this.slider.animate({ marginLeft : "+=" + this.OFFSET }, 1000, function() { // if we're on the first page, // disable prev button if (propublica.tySlideScreen <= 0) { that.el.addClass("inactive"); } }) } }); propublica.views.embedContainerOverlay = propublica.View.extend({ cssClass : "embed_box", bindings : { click : "showVid" }, render : function() { _.bindAll(this, 'showVid', 'showPopup', 'hidePopup'); TYYT.bind("stateChanged", this.hidePopup); TYYT.bind("playerReady", this.showPopup); this.popup = $("#slideshow_popup"); }, showPopup : function(e, opts) { if (opts && opts.inline) return; this.popup.fadeIn(); }, showVid : function(e) { var cur = $(e.currentTarget); var videoId = cur.data('id'); if (!videoId) return; if ($(window).width() < 400) { return window.location = "http://www.youtube.com/watch?v=" + videoId; } TYYT.fire("create", videoId, {inline : false}); this.popup.attr("data-id", videoId); if (cur.data("caption")) { $("#slideshow_popup #slideshow_popup_img .popup_img_caption").html("" + cur.data("caption") + "
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") } $("#slideshow_popup").addClass("img_popup").fadeIn(); } }) propublica.views.slideshowPopupCloseBox = propublica.View.extend({ id : "slideshow_close_box", bindings : { click : "closeBox" }, closeBox : function() { var popup = $("#slideshow_popup") popup.removeClass("img_popup"); $(".popup_img_inner").height("") $("#slideshow_popup #slideshow_popup_img .popup_img_inner, #slideshow_popup #slideshow_popup_img .popup_img_caption").empty(); TYYT.fire("destroy", popup.attr("data-id")); popup.hide(); } }); // countup CLOCK JS propublica.views.tyCountUp = propublica.View.extend({ id : "ty_countup", START : new Date("05 April, 1977 00:01:00"), render : function() { _.bindAll(this, 'diff') var that = this; window.setInterval(function() { $("#ty_countup").html(that.tmpl(that.diff())) }, 1000) }, tmpl : function(obj) { var str = [ "", "", "" + obj.years + "", "" + obj.months + "", "" + obj.days + "", "" + obj.hours + "", "" + obj.minutes + "", "" + obj.seconds + "", "", "", "years", "months", "days", "hours", "minutes", "seconds", "" ].join("\n"); return str; }, diff : function() { var obj = {}; // Set the unit values in milliseconds. var msecPerMinute = 1000 * 60; var msecPerHour = msecPerMinute * 60; var msecPerDay = msecPerHour * 24; var msecPerMonth = msecPerDay * 30; var msecPerYear = msecPerDay * 365; var startMsec = this.START; var interval = Date.now() - startMsec; obj.years = Math.floor(interval / msecPerYear); interval = interval - (obj.years * msecPerYear); obj.months = Math.floor(interval / msecPerMonth); interval = interval - (obj.months * msecPerMonth); obj.days = Math.floor(interval / msecPerDay ); interval = interval - (obj.days * msecPerDay ); obj.hours = Math.floor(interval / msecPerHour ); interval = interval - (obj.hours * msecPerHour ); obj.minutes = Math.floor(interval / msecPerMinute ); interval = interval - (obj.minutes * msecPerMinute ); obj.seconds = Math.floor(interval / 1000 ); return obj; } });Dose of Confusion
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Dose of Confusion
TwitterFacebookLink By T.Christian Miller and Jeff Gerth, ProPublica, Sept. 20, 2013, 10:00 a.m. Design & Development: By Krista Kjellman Schmidt, Lena Groeger, Al Shaw Safeguard the public interest.Support ProPublica’s award-winning investigative journalism.
OPELOUSAS, La. — On a chilly Friday night in January 2003, Christina Hutto took her 5-month-old daughter to Opelousas General Hospital, a brown building squatting near the center of this small Louisiana town.
A chubby girl with bright blue eyes and blond hair, Brianna had suffered from a cold and fever for several days. A nurse suggested Tylenol. He scribbled the dose on a piece of paper: one teaspoon every four hours.
Within days, Brianna was lying comatose in a pediatric intensive care unit — her life threatened not by a deadly virus or rare disease, but by an accidental overdose of one of the nation’s most popular over-the-counter pain relievers. Her liver had been destroyed by a toxic byproduct of the medicine that was supposed to help her.
The Huttos were blindsided. Like many Americans, Christina and Eric Hutto had trusted Tylenol, a brand synonymous with safety. Tylenol, as the advertisements proclaimed, was the No. 1 doctor-recommended brand of pain reliever; the one hospitals used most; the one used by moms decade after decade.
Yet Tylenol’s pediatric products had the potential for lethal confusion — and this was no secret to federal regulators or McNeil Consumer Healthcare, the division of Johnson & Johnson that manufactures the drug.
For at least 15 years, until 2011, McNeil continued selling two versions of Tylenol for young children, despite knowing that parents and even medical professionals mixed them up, sometimes with serious consequences. And the Food and Drug Administration failed to intervene.
googletag.display('google-Rt_Sdbr_Non-Mobile-Only300x250');The two types of pediatric Tylenol had a counterintuitive difference. Drop for drop, the strength of Infants’ Tylenol far exceeded that of Children’s Tylenol.
In addition, the active ingredient in Tylenol, acetaminophen, has what the FDA deems a narrow margin of safety. The drug is generally safe at recommended doses, but the difference between the dose that helps and the dose that can cause serious harm is one of the smallest for any over-the-counter drug.
By confusing the pediatric products and administering too much of the infants’ version, parents could inadvertently overdose their children. Other manufacturers also made two children’s products with different concentrations of acetaminophen.
Between 2000 and 2009, the FDA received reports of 20 children dying from acetaminophen toxicity – a figure the agency said likely “significantly underestimates” the problem. Three deaths were tied directly to mix-ups involving the two pediatric medicines. Such errors may have caused some of the other deaths, but the agency has acknowledged that its data lacks sufficient detail to determine the precise cause.
Similar gaps exist in data for non-fatal liver injuries. The FDA has estimated it may capture less than 1 percent of such cases. Still, one small study found that confusion between the two pediatric products was the most common reason for overdoses among kids with acetaminophen-related liver damage. A study conducted by McNeil found that about one child a year on average was hospitalized because of mix-ups involving its drugs.
Such tragic accidents are among the reasons that between 2001 and 2010, there were about twice as many deaths annually associated with acetaminophen than with all other over-the-counter pain relievers combined, according to data from the American Association of Poison Control Centers. On average, more than 150 Americans die accidentally each year from acetaminophen poisoning, most of them adults, Centers for Disease Control and Prevention data shows. Tens of thousands more are hospitalized for overdoses.
Over a span of decades, federal regulators have been slow to protect consumers in the face of the drug’s rising toll, and McNeil has argued against warning labels, dosing restrictions and other protective measures that would have affected its flagship brand.
The company and the FDA said they have done what they can to reduce overdoses through labeling changes, public education efforts and other measures.
McNeil pressed the FDA for years to allow it to add dosing instructions for children under 2 to its pediatric products; the government-approved label said only to ask a doctor how much to give kids of that age. The company presented mountains of data and made repeated public pleas in arguing for the change.
For more than a decade, the FDA deliberated on the company’s petition but never took action. The issue “requires careful consideration of myriad inter-related factors,” the agency said in a statement, including that “limited safety and efficacy data” existed for acetaminophen in children under two. Today, the agency said, it is continuing an effort to write “user-friendly” instructions for pediatric acetaminophen.
All along, there was another option. At any time, the FDA could have pushed McNeil and other manufacturers to switch to a single pediatric concentration. Or McNeil could have done so voluntarily, ensuring that no one could mix up the dose. Neither did.
Having two products allowed the company to sell to different consumers — parents of babies and toddlers on the one hand, and older children on the other.
Under oath in a lawsuit brought by the Huttos, McNeil’s former medical director, Anthony Temple, was asked how often mixing up the two pediatric products had led to liver injury. Over a 30-year period, he said, “There are maybe a couple of dozen, maybe a little more, where incidents of significant liver injury has occurred, and there’s probably a handful of those cases that were fatal.”
“And for 25 years you’ve elected to continue to offer Infants’ Tylenol in the concentrated form that has led to the death of babies, correct?” he was asked.
“Yes, we’ve continued to do it,” Temple testified.
The company viewed moving to a single concentration as “a second-best option,” Temple said in an interview.
“It’s easy looking back to say maybe we should have made a fix,” he said. But he explained that McNeil believed for years that the FDA was going to add dosing instructions. During that period, he said, the benefit to children warranted keeping the two versions on the market.
“One death is too many.”PeterMax Miller, a pharmaceutical marketing expert at the University of Colorado Denver and a former drug company executive
TwitterFacebook LinkPeterMax Miller, a pharmaceutical marketing ethicist at the University of Colorado in Denver and a former executive at a Johnson & Johnson competitor, said he saw the math — and the morality — differently. First, do no harm.
Asked if just one infant death should trigger a drug maker to pull a product, he replied that it would be “more than a trigger, that is a huge cannon.”
“One death is too many,” he added. “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.”
Two years ago, as federal regulators were considering pulling the product, and as lawmakers in Louisiana were weighing their own solution to the problem, McNeil and other companies voluntarily withdrew the stronger formulation of their infant drugs from U.S. store shelves.
That came too late for the Huttos.
Both Infants’ and Children’s Tylenol were on the shelves when Christina and her mother walked into the local Walmart after leaving the hospital in early 2003. They purchased what they had previously given Brianna — a bottle of the more concentrated Infant’s Tylenol.
They drove to their home in Krotz Springs, a tiny community of trailers and small tin-roofed houses nestled against a levee on the dark brown Atchafalaya River. It was here that Eric Hutto had fallen in love with Christina after they met at the “kissing log” — a creosote-covered post over a ditch that was a make-out spot in town.
They were young when they got married, only 17. With Christina pregnant, the couple worked hard to make their home safe for Brianna. Before her birth, they tore up the old carpet in their trailer to put in new, allergen-free carpet. They did the same thing in the kitchen, replacing the worn, old flooring with new linoleum. They furnished a nursery for her.
Christina loved her baby more than she could have believed — “like the sun had just opened a door in our lives,” she would say. Eric doted on his daughter, calling the day she was born the "happiest day." (Photos courtesy of the Hutto family)
A construction worker who loved hunting and fishing, Eric doted on his young daughter. He held her to him swaddled in a blanket, fed her, watched television with her. Christina loved her baby more than she could have believed — “like the sun had just opened a door in our lives,” she would say.
Over the weekend, the Huttos remembered, they dutifully began giving Brianna the dosage recommended by the nurse at the hospital. They used a small plastic cup with teaspoon indicators to measure the syrup. They used the dropper that came with the package to administer it. They made sure they were giving her the medicine at the right time intervals — no sooner than every four hours.
“There was no crying. There was no movement. She just became a vegetable.”Christina Hutto, Brianna’s mother
TwitterFacebook LinkBy Sunday morning, Brianna seemed worse. She was restless and vomiting. By that evening, she was listless. She wasn’t even responding to the sound of Christina’s voice. “Sunday, there was no crying. There was no movement. She just became a vegetable,” Christina said.
Christina had to go to her job at a truck stop, so Eric and his father, Jimmy, the local fire chief, decided to take Brianna back to Opelousas General.
As the evening wore on, things went from bad to worse. Brianna wasn’t responding to stimuli. She was dehydrated. The doctors were having trouble getting an IV into her. Her veins kept collapsing. Christina rushed to the hospital. She and Eric spent a sleepless night at the hospital with Brianna.
At the morning shift, Brianna’s regular pediatrician came into the hospital. Christina remembers that she saw Brianna and immediately screamed: “Why wasn’t I called? This baby is in bad shape!”
The doctor was confused. She suspected Brianna had ingested poison, but didn’t know what. She asked Eric if the family had lead or other dangerous substances in the house. Finally, she ordered up tests to check for liver damage and the levels of acetaminophen, the active ingredient in Tylenol, in Brianna’s blood.
The results showed Brianna’s liver enzymes were nearly 200 times higher than normal. And the amount of acetaminophen in her blood indicated that she had taken far more than the recommended dose.
Time was now of the essence. McNeil had helped to fund the development of an antidote to acetaminophen poisoning that is remarkably effective if administered within the first eight hours. Then its efficacy declines. Brianna had passed the window. Her liver was failing fast. But there was still a chance.
“It was like it was just a tunnel we was riding through that never was going to end.”Eric Hutto, Brianna’s father
TwitterFacebook LinkA medical helicopter whisked Brianna to New Orleans Children’s Hospital, where she could receive more specialized care.
There was no room on the helicopter for the Huttos. So Christina, Eric and Jimmy piled into Jimmy’s pickup, and started driving down Interstate 10, past swamp and cypress forest, toward New Orleans.
The two-hour drive was agony. Christina sobbed the entire way. Eric was bewildered. Three days ago, he had a child with a fever. Now she was being airlifted for a liver transplant.
“It was a long, long ride,” Eric said. “It was like it was just a tunnel we was riding through that never was going to end.”
It would take several years to sort out what happened. Opelousas General, as it turned out, did not use Infants’ Tylenol — precisely because hospital administrators wanted to avoid the risk of overdosing by confusing two different formulations. Nurses were used to giving dosage instructions based on the less-potent form, Children’s Tylenol.
So when she first got to the hospital on that January night, Christina said, she told the intake nurse that she had been giving Brianna Infants’ Tylenol. She said she pulled the bottle out of the diaper bag to show the nurse.
Brianna was "very, very happy, very outgoing," according to Christina, her mother. But that all changed when she got sick. (Photo courtesy of the Hutto family)
After Brianna was examined, a nurse in the emergency room handed Christina and her mother a form, which recommended ¾ of a teaspoon of Tylenol. Christina’s mother questioned the dose because she thought it was too high. When the form came back, the nurse had increased the dosage to 1 teaspoon.
However, nowhere on the form that the nurse gave Christina did it say the teaspoon dose was for Children’s Tylenol. And when Christina bought Infant’s Tylenol, as she had before, there was no way for her to double-check the nurse’s instructions, because there was no dosing information for a child under 2.
It was hardly a new problem.
McNeil built its business partly on providing relief to sick children. When it began selling Tylenol in 1955, one of its first products was a liquid form for children. In 1957, McNeil introduced a second pediatric medicine: Infant’s Tylenol. Originally prescription drugs, they became available as over-the-counter products by 1959.
The infant’s formula, meant for kids under 3, contained more than three times as much acetaminophen as the same volume of the children’s version, meant for those up to 12. Though it might seem counterintuitive to make a stronger Tylenol for younger kids, there were practical reasons to design the products this way.
The more concentrated infant’s formulation meant that parents had to force fewer drops down the throats of fussy babies to deliver the same amount of medicine. Having two concentrations “was considered a rational strategy to facilitate dosing for infants and children at the time it became available,” the FDA said in a statement.
Some experts believe that isn’t persuasive. “Babies drink 4 to 8 ounces of formula at a time. They can take a teaspoon of liquid,” said James Heubi, a pediatric gastroenterologist at Cincinnati Children’s Hospital Medical Center who has testified in court against McNeil. “There’s absolutely no reason to have two different concentrations on the market.”
Having two products is a common sales strategy, helping to reach different demographics. Johnson & Johnson does not release revenue information for Tylenol products, so it isn’t publicly known how much the two pediatric formulations generated. Industry-wide, infants’ strength products accounted for 12 percent of sales of over-the-counter acetaminophen in 2009 and children’s strength products accounted for about 16 percent, according to an FDA study.
“There’s absolutely no reason to have two different concentrations on the market.”James Heubi, a pediatric gastroenterologist at Cincinnati Children’s Hospital Medical Center
TwitterFacebook LinkMcNeil did not directly answer why it continued to keep two concentrations on the market. The company said that the “standard of care” in the U.S. included providing more concentrated products to infants to facilitate giving the medicine to babies.
“Sales were not an issue” in deciding whether to keep the two concentrations on drugstore shelves, said Temple, the company’s retired medical director.
Understanding of acetaminophen’s potential to harm children began emerging decades ago.
By the late 1960s, science showed that, at certain doses, acetaminophen could damage or even destroy the liver. Some research found that children were less vulnerable than adults to the drug’s toxic effects, but in a 1975 article, Barry Rumack, a toxicologist whose work McNeil later funded, noted the death in 1970 of a 3-year-old in England from acetaminophen poisoning. (The drug is known there and in many other countries as paracetamol.)
For many years, the chief concern was “unsupervised ingestion” – children getting into medicine bottles and taking too much acetaminophen. Such accidents are the reason for the majority of emergency room visits by kids suffering from potential overdose, studies show.
In those cases, parents often rush their child to the doctor, increasing the chance the antidote will be administered in time for it to work. But when parents or healthcare providers mixed up the two concentrations of pediatric Tylenol, they often wouldn’t realize anything was wrong for days, until symptoms became severe and the antidote was less likely to be effective.
In 1994, parents overdosed a 14-month-old girl by confusing the two Tylenol products. She lived but underwent a liver transplant. In a later statement quoted by newspapers, McNeil called her case a “tragic error and confusion on the part of the parents.”
Two-thirds of parents who brought children under 7 into city emergency rooms did not know the difference between concentrated infant’s drops and other formulations of acetaminophen, a study published in 2000 found.
As McNeil saw it, the problem had always been the label and its lack of instructions for children under 2. The FDA’s rationale was that parents with children that young should speak to a doctor in case the symptoms indicated a more serious condition.
In 1983, McNeil’s Temple tried to address this issue by writing a scientific article that included dosing instructions for children by weight and age. The company began handing out tear sheets with the information to doctors to pass on to parents. The tear sheets also functioned as a marketing tool for Tylenol, according to court records, offering discounts for the medicine.
Temple, whose research was supported by McNeil, later testified that the company considered the tear sheets an imperfect solution.
Starting in the mid-1980s Temple said, McNeil officials publicly and privately pushed the FDA to act — without success.
As research piled up in the 1990s on pediatric deaths and injuries, the FDA held a series of public meetings at which McNeil and others advocated for adding dosing instructions.
Doctors and pharmacists expressed growing concern about the two children’s concentrations. In 1997, Dr. Cheston Berlin, an influential professor of pediatrics at the Penn State University College of Medicine, said pediatricians were “mystified” by the different formulations and urged drug makers to move to a single version.
McNeil didn’t take this step. Nor did the FDA require it.
At the same hearing at which Berlin testified, an FDA advisory committee recommended adding dosing information for children under 2 to acetaminophen labels.
In 1999, the FDA approved such dosing instructions for pediatric medicines containing ibuprofen, another over-the-counter pain reliever, including Motrin, a brand marketed by McNeil.
But for products with acetaminophen, the FDA spurned the advisory committee’s recommendation. The agency insisted that the label should continue to tell parents to ask their pediatricians for the appropriate dose.
McNeil undertook other efforts to combat pediatric overdose. The company designed a special safety cap that made it more difficult to pour out the more concentrated infants’ formula.
The company also filed a formal petition asking the FDA to allow dosing instructions for young kids. It marshaled a growing stack of evidence that dosing confusion persisted even among consumers who sought medical advice.
More than half the calls to McNeil’s consumer hotline concerned parents with children under 2 asking for dosing information, McNeil told the FDA. Moreover, a company analysis showed, most dosing errors occurred when parents had obtained instructions from health professionals.
The FDA still put off action, saying that acetaminophen makers needed to supply even more data showing how the drug affected kids of different weights and ages. Unlike ibuprofen, acetaminophen had been approved under older safety rules which did not require extensive testing. And, the agency said in a statement, “there was not a lot of data on which to base dosing” for children using acetaminophen.
Dr. Charles Ganley, an FDA official who was in charge of regulating over-the-counter drugs, said at a 2002 hearing that the agency was “struggling” with McNeil’s request for dosing instructions. The agency had even written a proposal for instructions, he said, but there were complex issues involved — including the agency’s own burdensome rule-making procedures.
“It’s just not as straightforward as folks think,” he said at the hearing. “But it is a priority to get done.”
Still, more time passed with no decision — and no guidance for parents like the Huttos.
What Do You Think?Should American drugmakers have to limit acetaminophen pills sold over-the-counter?
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Weigh In LinkAs soon as Christina and Eric got to New Orleans Children’s Hospital, they rushed up to see Brianna.
They were shocked at what they saw: Brianna was on a hospital bed, tubes running everywhere. She seemed to be swelling up, almost like a balloon. Her skin was tight, her lips were cracked. Beeping noises filled the room.
Christina called out to her, and Brianna briefly opened her eyes. She raised her arms toward her mother and let out a strange cry. Christina rushed over and started singing a lullaby. Suddenly, Brianna started spitting up. Christina broke.
About two weeks after her first Christmas, Brianna died from acetaminophen toxicity. (Photo courtesy of the Hutto family)
“I couldn’t take it anymore. I ran out of the room. I couldn’t take it,” she said.
The doctors told the Huttos that Brianna was in an advanced stage of acetaminophen poisoning. Her liver was dying, and gases were building up inside her. The only hope was a liver transplant. By chance, the University of Nebraska, which had a specialized liver transplant center, had surgeons available for an operation.
A day after they arrived in New Orleans, the Huttos were on the move again, flying in a medical jet to Omaha.
Before they left, they had a priest administer last rites. Brianna had slipped into a coma. In the ambulance on the way to the hospital, her heart stopped beating. The nurse resuscitated her. Doctors told the Huttos that Brianna would have to breathe on her own in order to be considered a candidate for a transplant.
“I kept saying, “Hold on, hold on, hold on,’ ” Christina said. “She was fighting so hard.”
When the Huttos arrived in Omaha, doctors rushed Brianna into an intensive care unit. The Huttos had their livers tested for compatibility with Brianna. Christina could have part of her liver removed to transplant into Brianna.
That morning, Eric bought a stuffed animal for Brianna from the hospital store, a small purple lamb with the word “Faith” embroidered on its neck. As he returned, he saw the doctors rushing in and out of Brianna’s room.
“Something’s going on with Brianna,” he told Christina. A moment later, a priest entered the room, a team of doctors and nurses behind him. Brianna’s kidneys, heart and liver had shut down.
Brianna Hutto died at 11 a.m., Jan. 8, 2003.
“When you pick out colors, it’s supposed to be for prom dresses or Christmas pictures, not colors of the lining of her casket.”Christina Hutto, Brianna’s mother
TwitterFacebook LinkChristina had been on the phone with her mother when the priest walked in. She screamed. She dropped to the floor. Eric just stood there; he couldn’t comprehend what was happening.
“I felt dead. I felt empty inside, like my world ended,” he said. “It’s just the worst feeling imaginable. You can’t explain it besides my heart stopped. Everything stood still.”
The next few days passed in a blur. The autopsy results showed the cause of death: liver failure secondary to acetaminophen toxicity.
The couple flew back to New Orleans, Brianna’s body in the plane’s baggage compartment. They arranged for a viewing and funeral services at the church in Krotz Springs.
“You know, when you pick out colors, it’s supposed to be for prom dresses or Christmas pictures, not colors of the lining of her casket,” Christina said.
Brianna was buried in a small pink casket, in a grave behind the church.
Nearly a year passed before the Huttos decided that no other parents should suffer as they had.
On Jan. 7, 2004, one day short of the anniversary of Brianna’s death, the two teenagers filed a lawsuit against Opelousas General Hospital and McNeil, whose parent company, Johnson & Johnson, was one of the biggest corporations in America.
Their claim against McNeil: The drug company had not disclosed the full dangers of its product.
Have you or someone you know experienced acetaminophen poisoning - by accident or on purpose?About 160 Americans die accidentally each year from acetaminophen poisoning — and about the same number use the drug to commit suicides each year. ProPublica is seeking stories of those who have been harmed.
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Six years of legal wrangling took place before the lawsuit finally went to trial on June 15, 2010, in a courtroom in the basement of the old stone courthouse that dominates the Opelousas town square.
Before trial, Opelousas General Hospital and the attending physician admitted responsibility for giving the Huttos the wrong dosing information. They settled with the couple, leaving McNeil as the sole defendant.
McNeil’s defense was simple. The label on Infant’s Tylenol said to call a doctor for dosing instructions for a child under 2. The label also warned that “serious health consequences” could result from not following instructions — language approved by the FDA. The hospital had given out bad advice. Tragic as the case was, the couple had exceeded the recommended dose of Tylenol. McNeil was not to blame.
McNeil brought a large team of experienced lawyers to represent it at trial, but the company was not used to facing a jury. Of more than 150 lawsuits involving Tylenol examined by ProPublica, only a handful went to trial. Most were settled out of court, the terms sealed as part of the deal.
The Hutto trial, which lasted six days, featured emotional testimony from Christina and Eric. At one point, Christina broke down on the stand.
For McNeil, Temple testified that acetaminophen was the safest pain reliever on the market. He acknowledged that the company was aware of the problem of parents confusing Infant’s and Children’s Tylenol, but blamed the FDA for preventing the company from putting dosing instructions on the label.
An attorney representing Opelousas General Hospital pressed Temple on why McNeil hadn’t just eliminated one of the products if it knew that parents were making dosing errors and that children were being harmed.
“Rather than pull the products off the shelf, that’s sort of the cost of doing business?” the lawyer asked.
“McNeil felt that the benefit as — really it’s the FDA because it hasn’t pulled it off either — but the benefit to children of having the product available was appropriate to keep it in the marketplace, yes,” Temple responded.
The Huttos’ lawyers painted the trial as a David and Goliath affair, McNeil versus the young Louisiana couple.
The jury, which wasn’t told that the hospital had settled, wound up splitting the blame. The hospital was 70 percent at fault. McNeil was 23 percent at fault. Christina and her mother were 7 percent at fault. The jury awarded total damages of $5 million. Proportionally, the decision meant that McNeil owed the Huttos a little more than $1 million. But under a Louisiana law that limited damages paid by the hospital, the Huttos wound up with a little more than $2 million, before factoring in lawyers’ fees and trial costs.
Over the next two years, the company appealed the verdict to the U.S. Supreme Court. In fall 2012, the court declined to hear the case, letting the original jury verdict stand.
“Our hearts go out to those who have suffered from acetaminophen overdose, and to the families of those who have lost their lives as a result.”Statement by McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol
TwitterFacebook LinkThe company’s legal tactics left the Huttos bruised and stunned. One McNeil attorney had told them that he was sorry for their loss. But the fight left them convinced that McNeil cared more about money than the safety of its medicine.
“They probably spent more on lawyers than they did on the money they paid us,” Eric said. “Anybody with a heart, whether you own a business or not, should have said, ‘We’re at fault, proven guilty, here you all go. I hope y’all’s life gets better.’”
McNeil did not respond to questions regarding the Hutto case, but offered condolences to people who had suffered harm from the drug.
“Our hearts go out to those who have suffered from acetaminophen overdose, and to the families of those who have lost their lives as a result,” the company said in a written statement. “We will continue to work hard to educate and warn consumers of the dangers of acetaminophen overdose, reminding them to read labels on all medicines before taking them, to take medicines only as directed and to be aware that any medicine they take has risks.”
Christina did not find the company’s statement in any way consoling. She had read the label, followed its directions and lost her child.
“I did all those things,” she said.
As the Huttos’ case inched toward a conclusion, McNeil’s decision to continue selling two kinds of pediatric Tylenol with different strengths began to draw fire from health experts and regulators.
In 2009, the FDA convened a panel of experts to consider restrictions on acetaminophen, including whether to require companies to produce only one concentration of the drug for children. The FDA presented evidence that 10 children under 6 had died from acetaminophen poisoning between 2000 and 2009 — including Brianna Hutto.
Dr. Edwin Kuffner, McNeil’s vice president for medical affairs, and Temple both argued at the hearing that the answer was clear dosing instructions.
“It’s the labeling, not the concentration,” said Temple, who had retired from McNeil but flew in for the hearing at his own expense. He called the FDA’s inaction on the matter “astounding,” noting that the agency had promised to issue a ruling every year between 2003 and 2008 and never did.
The panel didn’t vote on whether to add dosing instructions. It voted, 36-1, that the FDA should mandate a single concentration of acetaminophen for children.
“I’ve not heard, in the information that we’ve reviewed, any compelling reason for why there should be these two formulations,” said one panelist, William Cooper, a professor of pediatrics at Vanderbilt University.
Once again, however, the FDA took no action on its experts’ recommendation.
Just one month after the meeting, McNeil wrote to FDA officials, proposing a plan in which it and other manufacturers would limit pediatric syrups “to a single concentration.” But it took almost two more years for McNeil and its competitors to take that step.
In April 2011, the Huttos’ attorney persuaded a Louisiana state legislator to introduce “Brianna’s Bill.” The measure said only pharmacies could sell children’s and infant’s acetaminophen products and that parents had to get written instructions when buying them.
In May, the FDA scheduled yet another hearing at which an expert panel examined the safety of children’s acetaminophen. Two weeks before the meeting, McNeil and other makers of acetaminophen announced what they called a voluntary decision to eliminate the two different concentrations of kids’ products.
Same Teaspoon, Different Dose5mL of Infant's Concentrated Tylenol has more than three times as much acetaminophen as 5mL of the Children's version.
TwitterFacebookLinkIn a letter to physicians, McNeil said the company believed a single concentration would improve patient safety. “The purpose of this transition is to help minimize the potential for medication errors due to confusion between infants’ and children’s acetaminophen products having different concentrations,” Kuffner wrote.
At the hearing, the FDA laid out its best estimate of the human cost of pediatric overdoses. The agency updated its analysis from 2009, finding that twice as many children — 20 — had died due to medication errors involving acetaminophen as it had reported before.
Moreover, agency officials said, they had come to suspect there were vastly more pediatric injuries from acetaminophen toxicity than they had known.
FDA researchers had compared two databases: the agency’s own MedWatch database, to which pharmaceutical companies are supposed to report serious drug side effects, and that of the American Association of Poison Control Centers, which collects data voluntarily submitted on poisoning cases across the country. The FDA estimated that the poison control center data captured about 400 pediatric liver injuries related to acetaminophen in 2008 and 2009 that its own reporting system did not.
Perhaps most striking was an analysis presented by Randall Bond, a pediatrician and poison control center director who testified on behalf of the Consumer Health Products Association, a trade group including McNeil and other acetaminophen makers.
From 2000 to 2004, Bond’s research showed, moving to a single concentration of acetaminophen for pediatric syrups could have prevented six serious injuries and two deaths.
Brahm Goldstein, a nonvoting member of the advisory panel who represented the pharmaceutical industry, criticized McNeil and other acetaminophen makers for not acting sooner.
“I’d like to congratulate the industry colleagues on moving to single dosing, but I would also like to chastise them,” Goldstein, an executive at Ikaria, a pharmaceutical company focused on critical care, told the group.
“I don’t know the specific number of children who have been injured and/or died because of medication errors due to this specific problem, but the fact that it’s taken over 10 years to get where we seem to be going this summer and later this year I think is shameful.”
The panel voted unanimously to recommend that the FDA add dosing instructions for children under 2 on pediatric acetaminophen.
To this day, the FDA has not put rules in place to require a single concentration of acetaminophen for children, relying instead on the industry’s voluntary step to move to a single concentration. This August, the industry filed a new petition requesting permission to put dosing instruction for kids on the single ingredient product remaining on the market.
In a written response to questions for this article, the agency said it was continuing to work on a formal regulation to settle pediatric dosing once and for all.
“We are working to reconcile the many related factors and establish a user friendly approach to proper pediatric dosing by age and weight in a future rule for children’s acetaminophen,” the agency said.
Overseas, in markets such as Mexico and Canada, McNeil still sells Infants’ and Children’s Tylenol with different concentrations of acetaminophen. The labels in those places give dosing information for children under 2.
The Huttos fell apart after Brianna’s death.
Christina’s grades plummeted, and she dropped out of college. She blamed herself for Brianna’s death, for not doing a better job of protecting her.
She divorced Eric. “I couldn’t stand being with someone, looking at that person knowing every day what I didn’t have anymore,” Christina said. “So I filed for divorce and just lost it. I went crazy.”
“I can’t tell you how many times I wake up in the middle of the night to make sure they’re still breathing.”Christina Hutto, Brianna’s mother
TwitterFacebook LinkChristina moved out of Louisiana, determined never to go back. She has remarried and now has four children.
“I can’t tell you about the fear that I have of my children getting sick. I can’t tell you how many times I wake up in the middle of the night to make sure they’re still breathing,” she said. “And I will do this for the rest of my life.”
Eric plunged into depression.
“Thoughts of suicide was there,” he said. “How I didn’t do it, I don’t know.”
Today, Eric lives in a small town on a spit of land south of Baton Rouge. He used the money from the settlement to start an auto upholstery business. He hunts. He fishes. And he visits Brianna’s grave once or twice a month.
“I tell her I love her and I miss her and wish she was still here and to watch over us and stuff,” he said. “I try to go by when I can. Sometimes I just don’t. It doesn’t feel good when you do go. It’s a sad, empty feeling.”
Related Story: Use Only as Directed
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Behind the
Numbers
By T.Christian Miller and Jeff Gerth, ProPublica, Sept. 20, 2013, 10:00 a.m. Safeguard the public interest.Support ProPublica’s award-winning investigative journalism.
How many people in the United States die or suffer serious harm from acetaminophen overdose?
To try to answer this question, ProPublica examined three sets of primary data, as well as dozens of scientific studies. While the data sets varied on the total number of deaths, all three showed an increase in acetaminophen-linked fatalities over much of the past decade, with only occasional year-to-year declines.
Here is an in-depth look at the numbers.
Data compiled by the U.S. Food and Drug Administration has linked as many as 980 deaths in a year to drugs containing acetaminophen. In addition, FDA reports of death associated with acetaminophen have been increasing faster than those for aspirin, ibuprofen and many other common over-the-counter pain medicines.
Data obtained from the U.S. Centers for Disease Control and Prevention show that more than 300 people die annually as a result of acetaminophen poisoning.
Beginning in 2006, according to the CDC, the number of people who died after accidentally taking too much acetaminophen surpassed the number who died from intentionally overdosing to commit suicide.
The American Association of Poison Control Centers (AAPCC), a nonprofit that receives federal funds, shows about 113 people dying each year as a result of overdosing on medicines with acetaminophen. Since 2006, acetaminophen has accounted for more fatalities than all other over-the-counter pain relievers combined, according to AAPCC data.
Why the large differences? Because each organization’s data has strengths and weaknesses.
The FDA relies primarily on individual case reports, called FDA Adverse Event Reports, submitted by drug makers, consumers and doctors. Drug makers must submit information about any cases they learn about involving side effects linked to their drugs, while reports by consumers and healthcare workers are voluntary. The reports often lack key information. By some estimates, the FDA system captures from 1 percent to 10 percent of adverse events involving drugs.
Most important, the reports do not demonstrate a causal connection between a person’s death and a particular drug, just an association. This is a crucial issue for acetaminophen, because that drug is often combined with other drugs into one medication. For example, the prescription painkiller Vicodin combines acetaminophen with the powerful opioid painkiller hydrocodone. If a person dies after taking Vicodin, the FDA report does not say whether it was caused by hydrocodone or acetaminophen, or even some other drug. So the FDA data only allows one to say a drug is linked to or associated with the death.
googletag.display('google-Rt_Sdbr_Non-Mobile-Only300x250');The CDC’s primary source of information for acetaminophen poisoning is death certificates submitted by health care professionals, coroners and medical examiners. These go into the agency’s Multiple Cause of Death database. The CDC estimates that it captures the vast majority of death certificates filed in the United States, and its format attempts to determine the primary cause of death for each case. But the quality of the reports depends upon the judgments of the local officials who review medical files, conduct autopsies and ultimately fill out death certificates.
The AAPCC draws its data from the dozens of poison control centers throughout the nation that advise people who fear they have ingested a poisonous substance, as well as healthcare providers who treat such patients. Those calls form the basis of the AAPCC’s National Poison Data System. Its information is quite detailed – more so than the other two data sets.
But it, too, has a limitation: Not everybody who overdoses on a drug calls a poison control center. In particular, the AAPCC data may underestimate fatalities for the simple reason that there is little need to call a poison control center if a person has already died. Poison control center officials have acknowledged that the AAPCC’s overall fatality numbers capture only a fraction of poisoning deaths.
While the AAPCC publishes annual reports with detailed tables, its full data set is expensive. The organization receives substantial taxpayer money from the CDC, yet it charges citizens and even other government agencies for more detailed access to its raw data.
After examining the data sets and checking the numbers with the CDC and AAPCC, ProPublica has generally relied upon the CDC figures as a primary source of information. We judged that the death certificate information, while imperfect, represented the most rigorous collection of data. (And yes, we are aware of the series we did pointing out the flaws of death investigations in America.) However, we have also used information from the FDA and the AAPCC, such as when the organization’s data was used in a regulatory setting or when it was the sole source of information on a particular issue.
Both the CDC and the AAPCC data show that acetaminophen toxicity results in more deaths per year than do drugs such as ibuprofen and naproxen, the so-called NSAIDs (non-steroidal anti-inflammatory drugs). McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol and ibuprofen under the Motrin brand, argues that the CDC and AAPCC death counts do not contain enough information to compare the relative safety of different medications. The company contends that those databases “cannot be used in isolation” but must be taken in context with the totality of information available on the risks of the drugs.
In addition, McNeil and some epidemiologists argue that these data sets undercount deaths resulting from chronic use of NSAIDs. They point to studies showing the well-established medical fact that even at recommended doses, NSAIDs can cause stomach bleeding, sometimes serious or even fatal.
If all deaths caused by NSAIDs were counted, McNeil has argued, then those drugs could cause as many or more deaths per year than acetaminophen.
The CDC and AAPCC data sets count actual deaths attributed to medications such as acetaminophen and NSAIDs. They are not extrapolations.
To support its argument that NSAIDs may cause the greater number of deaths, McNeil has pointed to various studies – but they don’t count actual deaths attributed to NSAIDs. Instead, they use assumptions and mathematical models to estimate NSAID-related deaths.
Those studies have other limitations. McNeil and other researchers have cited a 1999 study that “conservatively estimated” as many as 16,500 U.S. deaths a year were related to NSAIDS. However, the lead author of that study wrote in an email that the estimate is outdated and “today is probably one-fourth of that.” Also, that estimate specifically excludes over-the-counter NSAIDs, meaning that it applies to prescription NSAIDs only.
That’s an important limitation. Some NSAIDs are only sold by prescription because they have not been deemed safe enough to be sold over-the-counter. Also, NSAIDs such as ibuprofen can have higher recommended daily doses when sold by prescription than when sold over-the-counter. Acetaminophen, however, has the same maximum recommended daily dose, whether obtained by prescription or not. So comparing prescription NSAIDs to acetaminophen, some researchers have argued, is an apples-to-oranges comparison.
An apples-to-apples comparison, these experts say, would look at deaths caused by over-the-counter NSAIDs to those caused by acetaminophen. No study McNeil cited does that.
One study, partly funded by McNeil, does something similar. It makes an estimate, based on mathematical modeling, about the relative risk of death for acetaminophen and over-the-counter NSAIDs. It found that acetaminophen has a lower risk of causing death than does over-the-counter ibuprofen or naproxen. However, the study states that its analysis is based on some findings “which are subject to considerable error,” the authors write. “We also made a number of assumptions for ease of comparison.” One of those assumptions: Everyone takes the medicines as directed and no one overdoses. But overdosing is the main cause of acetaminophen-related deaths.
For data on nonfatal injuries, ProPublica looked to a study that analyzed several databases. 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.
A note for data wonks. One fundamental question can be only roughly approximated: What is the fatality and injury ratio for acetaminophen? That is, how many deaths and serious injuries happen for every 100,000 people who take the drug? Various attempts have been made to answer that question. But nobody knows the numerator, the exact number of deaths and injuries. And no one knows the denominator, how many doses of acetaminophen are sold each year or, of those sold, how many are actually ingested by people. Over-the-counter acetaminophen is sold in bottles containing as many as 1,000 pills; how many people take all of those pills?
All we can say is that only a tiny fraction of people who take acetaminophen appear to suffer injuries or fatalities as a result. Adding up the highest estimates of injuries and deaths linked to acetaminophen would result in a total of a little over 110,000 incidents annually. About 27 billion doses were sold in 2009, the most recent year for which figures are publicly available. If all the pills were consumed, that would mean about one injury for every quarter million doses. In actuality, that almost certainly lowballs the rate of injuries, but by how much, nobody knows.
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On average, more than 150 Americans die each year from accidentally taking too much acetaminophen, the active ingredient in Tylenol, and tens of thousands more go to emergency rooms or are hospitalized with liver damage associated with the drug, according to government data. About the same number use acetaminophen to commit suicides each year.
I almost died once from too much Tylenol. Great presentation and database from @a_l @lenagroeger @propublica http://t.co/7h4aE6hAmX
— Andrei Scheinkman (@ascheink) September 20, 2013Is it possible to OD on Tylenol?? I've taken so much this week... #Ouch
— Brittanie Graham (@brittaniegraham) September 23, 2013View more of this conversation on Twitter.
But it’s still unclear exactly how many people are harmed by acetaminophen overdoses. Although drug manufacturers are required to report adverse events to the FDA, they don't hear of every case. Hospital and death-certificate data also have problems — for example, the cause of liver failure might not be correctly diagnosed.
We are interested in hearing from people who have experienced acetaminophen poisoning or whose loved ones have suffered this problem. All information will be kept confidential with ProPublica reporters. However, you may also wish to file a report directly with the FDA and can download a consumer report form here.
When Will FDA Finally Decide on Safety Guidelines for Acetaminophen, Including Tylenol?
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By the 1970s, it was clear that there were serious risks associated with an overdose of acetaminophen, the active ingredient in Tylenol. Scientists noted more cases of people accidentally taking too much or overdosing on purpose to attempt suicide. In 1975, the prestigious medical journal the Lancet warned that acetaminophen toxicity was a “serious problem.” In 1977, a panel of experts urged the Food and Drug Administration to add a clear, specific warning to acetaminophen drug labels that an overdose can cause “severe liver damage.” But it would be decades before the agency required the warning or drug makers such as McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, added it. After more than 35 years, the FDA still hasn't finalized how it will regulate acetaminophen. Just last month, the agency blew past another deadline. Despite the risks, acetaminophen has become ubiquitous.
PHOTO: LARS KLOVE 600 medications with acetaminophen currently approved for sale in the U.S. 27 acetaminophen doses sold in the U.S. in 2009 1,567 Americans who died from 2000-2010 from accidental acetaminophen poisoning 1,400 Americans who committed suicide by taking acetaminophen from 2000-2010Should FDA Require All Acetaminophen Drugs to Carry Black Box Warnings?
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What do you think? Add Your Reaction Question: Should FDA mandate black box warnings for all acetaminophen? ReactionsPowered by ReadrBoard: Tell us what you think by highlighting any phrase or comment and adding your reaction.
A few things to know:
• Two different agencies control advertising for drugs. The FDA regulates advertising for prescription drugs and can mandate warnings (like the ones you see at the end of commercials). But for over-the-counter drugs, a different agency, the Federal Trade Commission, oversees marketing claims.
• For prescription drugs, the FDA can require so-called black box warnings when drugs pose a potentially "serious or life-threatening" risk. The agency requires all prescription drugs containing acetaminophen to carry a black box warning that an overdose can result in liver transplant or death. For over-the-counter Tylenol and its generic equivalents, the FDA requires no warning that overdose can be fatal.
• For example, Tylenol with Codeine No. 3, made by a Johnson & Johnson company, combines acetaminophen with codeine and can only be bought with a prescription. Tylenol 3, as it is commonly known, carries a black box warning that overdose can lead to death. By contrast, Extra-Strength Tylenol, sold over the counter, carries no such warning. So: two pills containing acetaminophen, made by the same corporation, carrying the same brand name, sold in the same country, regulated by the same agency are subject to different safety standards.
• The FDA also requires drug makers to disclose the potential dangers of prescription acetaminophen in television advertising, but the FTC does not require the same for advertising over-the-counter versions of the drug.
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ReactionsQuestion: Should drugmakers limit acetaminophen quantities sold over-the-counter?
ReactionsWho’s Responsible for Deaths Caused by Mixing up Infants’ and Children’s Tylenol?
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Who's most responsible? Add Your Reaction Question: Who's most responsible for infant deaths? ReactionsPowered by ReadrBoard: Tell us what you think by highlighting any phrase or comment and adding your reaction.
A few things to know:
• McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, and the Food and Drug Administration both knew for 15 years about the sometimes-lethal confusion over its Tylenol products for infants and children. Drop for drop, the strength of Infant’s Tylenol used to far exceed that of Children’s Tylenol. By confusing the products and administering too much of the infant’s version, parents or caretakers could inadvertently overdose their children.
• Aware of the problem, McNeil continued to sell the products as it pleaded with the Food and Drug Administration to add a dosing label that the company believed would solve the problem. The current label instructs consumers to call a doctor to get dosing instructions for children under two — but there is ample evidence that even healthcare providers sometimes mix up the products and give the wrong dosing instructions. McNeil wanted the FDA to add specific instructions by age and weight.
As of 2011, McNeil and other acetaminophen makers voluntarily agreed to stop selling two different concentrations of pediatric products. Today, infants’ and Children’s Tylenol have the same concentration, eliminating the potential confusion between two formulations.
• The FDA, has yet to take formal action. It has not mandated a single concentration. Nor has it decided whether to implement McNeil’s suggestion to add dosing information for kids under two.
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A few things to know:
• Two different agencies control advertising for drugs. The FDA regulates advertising for prescription drugs and can mandate warnings (like the ones you see at the end of commercials). But for over-the-counter drugs, a different agency, the Federal Trade Commission, oversees marketing claims.
• For prescription drugs, the FDA can require so-called black box warnings when drugs pose a potentially "serious or life-threatening" risk. The agency requires all prescription drugs containing acetaminophen to carry a black box warning that an overdose can result in liver transplant or death. For over-the-counter Tylenol and its generic equivalents, the FDA requires no warning that overdose can be fatal.
• For example, Tylenol with Codeine No. 3, made by a Johnson & Johnson company, combines acetaminophen with codeine and can only be bought with a prescription. Tylenol 3, as it is commonly known, carries a black box warning that overdose can lead to death. By contrast, Extra-Strength Tylenol, sold over the counter, carries no such warning. So: two pills containing acetaminophen, made by the same corporation, carrying the same brand name, sold in the same country, regulated by the same agency are subject to different safety standards.
• The FDA also requires drug makers to disclose the potential dangers of prescription acetaminophen in television advertising, but the FTC does not require the same for advertising over-the-counter versions of the drug.
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Reactions -->How Many Die From Medical Mistakes in U.S. Hospitals?
It seems that every time researchers estimate how often a medical mistake contributes to a hospital patient’s death, the numbers come out worse.
In 1999, the Institute of Medicine published the famous “To Err Is Human” report, which dropped a bombshell on the medical community by reporting that up to 98,000 people a year die because of mistakes in hospitals. The number was initially disputed, but is now widely accepted by doctors and hospital officials — and quoted ubiquitously in the media.
In 2010, the Office of Inspector General for Health and Human Services said that bad hospital care contributed to the deaths of 180,000 patients in Medicare alone in a given year.
Now comes a study in the current issue of the Journal of Patient Safety that says the numbers may be much higher — between 210,000 and 440,000 patients each year who go to the hospital for care suffer some type of preventable harm that contributes to their death, the study says.
That would make medical errors the third-leading cause of death in America, behind heart disease, which is the first, and cancer, which is second.
The new estimates were developed by John T. James, a toxicologist at NASA’s space center in Houston who runs an advocacy organization called Patient Safety America. James has also written a book about the death of his 19-year-old son after what James maintains was negligent hospital care.
Asked about the higher estimates, a spokesman for the American Hospital Association said the group has more confidence in the IOM’s estimate of 98,000 deaths. ProPublica asked three prominent patient safety researchers to review James’ study, however, and all said his methods and findings were credible.
What’s the right number? Nobody knows for sure. There’s never been an actual count of how many patients experience preventable harm. So we’re left with approximations, which are imperfect in part because of inaccuracies in medical records and the reluctance of some providers to report mistakes.
Patient safety experts say measuring the problem is nonetheless important because estimates bring awareness and research dollars to a major public health problem that persists despite decades of improvement efforts.
“We need to get a sense of the magnitude of this,” James said in an interview.
James based his estimates on the findings of four recent studies that identified preventable harm suffered by patients – known as “adverse events” in the medical vernacular – using use a screening method called the Global Trigger Tool, which guides reviewers through medical records, searching for signs of infection, injury or error. Medical records flagged during the initial screening are reviewed by a doctor, who determines the extent of the harm.
In the four studies, which examined records of more than 4,200 patients hospitalized between 2002 and 2008, researchers found serious adverse events in as many as 21 percent of cases reviewed and rates of lethal adverse events as high as 1.4 percent of cases.
By combining the findings and extrapolating across 34 million hospitalizations in 2007, James concluded that preventable errors contribute to the deaths of 210,000 hospital patients annually.
That is the baseline. The actual number more than doubles, James reasoned, because the trigger tool doesn’t catch errors in which treatment should have been provided but wasn’t, because it’s known that medical records are missing some evidence of harm, and because diagnostic errors aren’t captured.
An estimate of 440,000 deaths from care in hospitals “is roughly one-sixth of all deaths that occur in the United States each year,” James wrote in his study. He also cited other research that’s shown hospital reporting systems and peer-review capture only a fraction of patient harm or negligent care.
“Perhaps it is time for a national patient bill of rights for hospitalized patients,” James wrote. “All evidence points to the need for much more patient involvement in identifying harmful events and participating in rigorous follow-up investigations to identify root causes.”
Dr. Lucian Leape, a Harvard pediatrician who is referred to the “father of patient safety,” was on the committee that wrote the “To Err Is Human” report. He told ProPublica that he has confidence in the four studies and the estimate by James.
Members of the Institute of Medicine committee knew at the time that their estimate of medical errors was low, he said. “It was based on a rather crude method compared to what we do now,” Leape said. Plus, medicine has become much more complex in recent decades, which leads to more mistakes, he said.
Dr. David Classen, one of the leading developers of the Global Trigger Tool, said the James study is a sound use of the tool and a “great contribution.” He said it’s important to update the numbers from the “To Err Is Human” report because in addition to the obvious suffering, preventable harm leads to enormous financial costs.
Dr. Marty Makary, a surgeon at The Johns Hopkins Hospital whose book “Unaccountable” calls for greater transparency in health care, said the James estimate shows that eliminating medical errors must become a national priority. He said it’s also important to increase the awareness of the potential of unintended consequences when doctors perform procedure and tests. The risk of harm needs to be factored into conversations with patients, he said.
Leape, Classen and Makary all said it’s time to stop citing the 98,000 number.
Still, hospital association spokesman Akin Demehin said the group is sticking with the Institute of Medicine’s estimate. Demehin said the IOM figure is based on a larger sampling of medical charts and that there’s no consensus the Global Trigger Tool can be used to make a nationwide estimate. He said the tool is better suited for use in individual hospitals.
The AHA is not attempting to come up with its own estimate, Demehin said.
Dr. David Mayer, the vice president of quality and safety at Maryland-based MedStar Health, said people can make arguments about how many patient deaths are hastened by poor hospital care, but that’s not really the point. All the estimates, even on the low end, expose a crisis, he said.
“Way too many people are being harmed by unintentional medical error,” Mayer said, “and it needs to be corrected.”
See how you can help ProPublica investigate patient safety and join our Facebook group on the topic.
Admissions Directors at Public Universities Speak Honestly (and Anonymously) About Their Goals
As we detailed last week, many public universities, suffering from state budget cuts or hungry for prestige, have made it a priority to attract out-of-state students, who pay higher tuition, and those who will help boost the schools’ place in college rankings.
But a newly released survey by Inside Higher Ed of admissions directors directly about their priorities, allowing them to respond anonymously. The survey, of course, is of admissions directors -- so it’s focused more on what type of students schools are going after in the recruitment stage, and less on the students who gets financial aid as a sweetener to prompt enrollment.
Still, it’s a reflection of some of the same priorities -- including a strong interest in out-of-state students and international students, who typically bring in more revenue, even with modest discounts.
For instance, 80 percent of admissions directors surveyed at public four-year universities agreed or strongly agreed that they were likely to increase their efforts to recruit out-of-state students. The percentage was slightly lower -- but still 66 percent to 72 percent, depending on the type of public institution -- for international students.
The survey also has some telling results about the popularity of so-called merit aid, which universities use to give discounts to particularly appealing students.
About two-thirds of admissions directors at public universities said that they would likely increase their efforts to recruit students with merit scholarships. Most also said they didn’t see a problem with using institutional resources on merit aid -- even though as we noted, investing resources in merit aid often means giving it to students who don’t need it, and not having much left over for those who do.
Over the long term, state schools have been giving a growing share of their grants to wealthier students, and a declining share to the poorest students, as we reported. They’ve also been serving a shrinking portion of the nation’s needy students, leaving community colleges and for-profit colleges to take on more of that responsibility.
Asked about first-generation college students, the responses from admissions directors indicated that they were also a target population, though perhaps less so relative to out-of-state or international populations: 62 percent of admissions directors at public research universities said they’d likely increase recruitment efforts for first-generation populations, and that figure was 55 percent for master’s/bachelor’s degree public institutions.
For a look at the full report, head to Inside Higher Ed. And if you’re admissions director who’d like to chat more, why don’t you send us an email?
Danziger Bridge Convictions Overturned
A federal judge on Tuesday overturned the convictions of five New Orleans police officers tied to the shooting of unarmed civilians during the aftermath of Hurricane Katrina, finding that prosecutors in the case had engaged in “grotesque” misconduct.
In a blistering and meticulously detailed 129-page ruling, U.S. District Judge Kurt Engelhardt found that federal prosecutors in New Orleans had anonymously posted damning online critiques of the accused officers and the New Orleans Police Department before and during the 2011 trial, a breach of professional ethics that had the effect of depriving the officers of their rights to a fair trial.
The judge granted the officers’ request for a new trial.
“Re-trying this case is a very small price to pay in order to protect the validity of the verdict in this case, the institutional integrity of the Court, and the criminal justice system as a whole,” Judge Engelhardt wrote.
The judge’s decision nullifies – at least temporarily – a key success in the U.S. Department of Justice’s half-decade effort to clean up the troubled New Orleans Police Department. Four of the five officers had been accused of firing on a group of civilians on or near the Danziger Bridge on Sept. 4, 2005, killing two people and seriously injuring others; a fifth officer had been charged with covering up the shooting.
The judge’s ruling excoriated two former top attorneys in the federal prosecutor’s office in New Orleans, as well as a lawyer in the Justice Department’s Civil Rights Division who had played a role in the case. The prosecutors posted comments about the Danziger case on NOLA.com, the website of the New Orleans Times-Picayune, as the case was still unfolding. The comments included a variety of attacks on the police department, calls for guilty verdicts and encouragements to other anonymous commentators to take apart the defense being offered by the five officers.
Engelhardt wrote that he was unaware of any other case in which “prosecutors acting with anonymity used social media to circumvent ethical obligations, professional responsibilities, and even to commit violations of the Code of Federal Regulations.” He called the behavior of prosecutors “bizarre and appalling.”
The Justice Department, in a statement, said it was disappointed in the judge’s action.
“We are reviewing the decision and considering our options,” the statement said.
Judge Engelhardt’s ruling sets the stage for another round of trials for former detective Arthur Kaufman, who was charged with directing an extensive cover-up, as well as former officers Anthony Villavaso, Kenneth Bowen, Robert Gisevius, and Robert Faulcon, who were accused of firing on the civilians. Judge Engelhardt had overseen the trial and sentenced the officers to prison terms ranging from 6 to 65 years.
Lawyers for the officers subsequently asked the judge to overturn the conviction, saying the prosecutor’s office had “engaged in a secret public relations campaign” to inflame public opinion against the officers and to secure their convictions. The judge did not find evidence of an organized campaign, but said the conduct of the individual prosecutors had wound up having the same effect.
Two of the prosecutors involved in the online posting, Sal Perricone and Jan Mann, resigned after their conduct became known. The D.C.-based Justice Department lawyer implicated in the scandal, Karla Dobinski, is a veteran of the Civil Rights Division. It is unclear whether her employment status has been affected by the revelations.
News that some federal prosecutors in the New Orleans office had improperly posted comments online first broke in 2012, and ultimately cost Jim Letten, the office’s top official, his job. The Department of Justice’s Office of Professional Responsibility launched an investigation.
But Judge Engelhardt’s ruling called into question just how vigorous and comprehensive a probe that has been.
Obama Administration Helped Kill Transparency Push on Military Aid
The U.S. spent roughly $25 billion last year on what’s loosely known as security assistance—a term that can cover everything from training Afghan security forces to sending Egypt F-16 fighter jets to equipping Mexican port police with radiation scanners.
The spending, which has soared in the past decade, can be hard to trace, funneled through dozens of sometimes overlapping programs across multiple agencies. There’s also evidence it’s not always wisely spent. In Afghanistan, for instance, the military bought $771 million worth of aircraft this year for Afghan pilots, most of whom still don’t know how to fly them.
Last year, legislators in the House drafted a bill that would require more transparency and evaluation of security and all foreign aid programs. The bill was championed by an unlikely coalition of Tea Party budget hawks and giant aid groups such as Oxfam America.
But the Obama administration successfully pushed to have security assistance exempted from the bill’s requirements, according to a letter obtained by ProPublica and interviews with Congressional staffers.
The Pentagon wrote that it “strongly” opposed last year’s bill in a statement to Congressional staff laying out its “informal view” last December. “The extensive public reporting requirements raise concerns,” the letter said. “Country A could…potentially learn what Country B has received in military assistance.” Foreign governments would also “likely be resistant” to monitoring and evaluation from the U.S. Staffers say the State Department had also resisted the bill’s increased oversight of security assistance. (The State Department declined our requests to discuss that.)
Two weeks later, the House passed a version that covered only “development assistance.” The bill never made it to a vote in the Senate.
The State and Defense Departments, which handle most security assistance, “really are scared,” said a House staffer who worked on last year’s bill. “They’re afraid of transparency about what the money is funding, where the weapons are going, who is getting training.”
As it is now, the staffer said, “some reports come two or three years after the fact, and the data is not easily manipulable.”
Increased oversight of security assistance is needed, said Walter Slocombe, former Undersecretary of Defense for Policy, who recently led a government-sponsored study on the issue. The problem is that “a lot of these programs have been developed ad hoc,” he said. “There’s not much coordination among agencies, though often they are trying to do more or less the same thing.”
New versions of the bill have been reintroduced in the House and Senate. This time, the administration’s stance isn’t clear. A spokesman for the National Security Council declined to comment, as did the Pentagon.
This year’s bill has a loophole for security spending: a waiver allowing the Secretary of State to exempt such programs if he deems it in the “national interest.”
Still, including security programs in the bill at all is “going to be a bit more difficult,” said an aide to one of the House bill’s co-sponsors, Gerry Connolly, D-Va. The exemption requires the State Department to tell Congress which programs it isn’t including, and why.
Lauren Frese, a State Department foreign assistance official said, “We support Congress’ objectives with the bill. It’s more a matter of making sure we’re not legislating something that isn’t aligned with what we’ve already got going on.” As the White House points out, it has already required agencies to be more transparent about spending on foreign aid. Agencies must upload budget data to a central public dashboard, foreignassistance.gov, though the site’s data is currently incomplete and information from the Defense Department is available only in generic categories. The bill would turn such directives into law.
The legislation also goes further. It would require the State Department to develop guidelines for monitoring and evaluating aid’s effectiveness across agencies.
In a hearing in April, the House bill’s co-sponsor, Ted Poe, R-Texas, said that “Americans want to see [whether] the money that we're sending to NGOs, the governments, et cetera is working or not working.”
Representative Connolly hopes the bill will help the public “better understand the rationale for aid, and the context: what a small, small part of the government’s budget it represents,” he told ProPublica. Indeed, foreign aid makes up only about 1 percent of the federal budget.
Supporters of the bill say excluding security assistance would leave a huge gap.
In January, an independent advisory board to the State Department recommended comprehensive reform of the whole concept of security assistance, calling for concrete objectives, better long-term monitoring, and a greater emphasis on non-military programs, such as programs to strengthen justice systems. (A few months later, the White House issued a policy directive that pledged to take on many of the same issues.)
“Nobody looks at it systematically,” said Gordon Adams, who worked on national security and international affairs for the Office of Management and Budget in the 1990s and has argued for a reduced military role in security assistance. That’s in part a reflection of how the landscape of programs has grown and fragmented in recent decades. Security assistance grew 227 percent between fiscal years 2002 and 2012, to a peak of $26.8 billion, according to data collected by the Stimson Center, where Adams is a fellow. That growth comes largely from programs in Iraq and Afghanistan, which are beginning to be scaled back. This year’s budget still allocated more than $20 billion across State and Defense.
State officially oversees all foreign aid, including many programs traditionally thought of as “military,” like weapons sales, but the Pentagon expanded its portfolio of “military operations other than war” and special operations in the 1990s. After 9/11, Congress also legislated new programs related to the “war on terror,” such as the Combating Terrorism Fellowship Program and the Coalition Support Fund. With its Afghan programs, the Pentagon accounts for more than half of all security spending – not counting covert operations.
Last year, then-Defense Secretary Leon Panetta promoted training and aid to partners as “low cost and small-footprint approaches” to military objectives.
The Pentagon’s increased role in foreign aid highlights a long-standing tension between the State Department and the military, which always has more cash on hand. “If you’ve got a $600 billion budget it’s easier to squeeze in a few million dollars here and there,” said Slocombe, who chaired the study for the State Department.
Countless examples from Afghanistan illustrate the problem of lack of both long-term planning and cooperation between agencies. In 2010, ProPublica and Newsweek documented the failures of the police training program, which had by then cost $6 billion. Responsibility shifted between agencies and contractors, and State and Defense squabbled “over whether the training should emphasize police work or counterinsurgency.” Last year, in one police facility built by the Army Corps of Engineers, the inspector general for Afghanistan reconstruction found a well building being used as a chicken coop. Another encampment, designed for 175 police, was occupied by just 12. The men didn’t even have keys for many of the buildings.
Other reports found the military paid $6 million for vehicles that were destroyed or hadn’t been seen in years, and that $12.8 million in electrical equipment was sitting unused, as Defense and USAID each expected the other to install it.
Afghanistan is an exceptional case, given the scale of the spending and wartime conditions. But it also has the scrutiny of a special inspector general and a large U.S. presence. Security assistance to other countries has far fewer eyes on it – or a clear idea of what the objectives for the aid are. Empowering local police and armies can have more severe political and human rights repercussions than digging wells. “It engages us with a bunch of countries where our interests are at best opaque,” said Adams.
Some programs are designed for political and diplomatic reasons (as was long the case with arm sales to Egypt), while others are meant to build up a country’s ability to help the U.S. in its aims, such as countering terrorism or drug-dealing. In other words, giving a country what it wants, versus what the U.S. thinks it needs. (In fact, the Government Accountability Office found that branches of the military differ on which programs are supposed to do what.)
In a February testimony, the GAO said that few of the military’s training programs had looked carefully at long-term impacts. “Reporting on progress and effectiveness,” had in some cases “been limited to anecdotal information.” For example, while Yemen has received over $360 million from two of the military’s new counterterrorism programs, due to security concerns the Pentagon has yet to evaluate whether that money’s had any effect.
The House bill’s sponsors believe it could help with these problems of planning and communication. The bill “is not designed to be hostile or adversarial for the Pentagon and State Department,” said Representative Connolly. “It’s designed to provide them with a more cogent rationale for these programs.”
Discussion: How Can We Keep Public Universities Accessible?
Public universities have a vital public mission — backed by decades of public investment — to provide access to an affordable education for students. But faced with dwindling state support, many state universities have shifted their financial-aid dollars to attract students who will help schools generate more tuition revenue or move up in the rankings.
As Marian Wang’s recent investigation found, public universities have been giving a growing share of grants to the wealthiest students, and a shrinking share to the poorest students. A rising sticker price and a drop in available aid means many of the lowest-income students are being squeezed out of an affordable public education.
What should be done about how schools are using their financial aid? With budget cutbacks, how can public schools mind their bottom line while staying accessible for the lowest-income students? We had higher education experts weigh in on Reddit on Thursday. Here are some highlights:
Jerry Lucido, head of the University of Southern California Center for Enrollment Research Policy and Practice:
I have made the argument in a recent Center for American Progress report that all institutions could cut back non-need based aid (of all types) in favor of need-based aid without impact on rankings and for the public benefit. Public institutions, as the article notes, should certainly do so, but private institutions are also held in the public trust as "non-profit" entities and should not be left off the hook. Institutions could reduce non-need based aid an agreed upon fixed percent per year, moving it to needy students, but one institution will not do it if all do not come along. Department of Justice concerns about "price fixing" make this cooperation difficult. The DoJ and others should not consider this fixing prices, given that competition will remain the same. Overall costs would drop for needy students if this were permitted.
Anthony Carnevale, Director and Research Professor of the Georgetown University Center on Education and the Workforce:
What can be done? In combination, both race- and class-based affirmative action can at least ensure that highly qualified African-American, Hispanic, and lower-income students gain access to well-funded and selective colleges that lead to elite careers. But affirmative action is not enough to make more than a dent in the larger systematic racial and class bias in the core economic and educational mechanisms at the root of inequality. Affirmative action, whether it is race —or class-based— or some combination of the two can help out those who strive and overcome the odds, yet does relatively little to change the odds themselves. There are always African-American, Hispanic, and working class strivers who beat the odds, but for the mass of disadvantaged people it is the odds that count. The odds are stacked against African-American, Latino, and low-income students. Disadvantage, like privilege, comes from a complex network of mutually reinforcing economic and educational mechanisms that only can be dealt with through a multifaceted economic and educational policy response.
Richard Kahlenberg, author and senior fellow at The Century Foundation, where he writes about a variety of education issues:
Marian Wang's terrific article shows that between 1996 and 2012, public institutions moved scarce resources away from low-income students to wealthy students. This makes little sense from a public policy standpoint. The reason taxpayers support financial aid is that our whole society benefits when more people go to college and get a great education. Wealthy students will go to college with or without aid. So federal policies should provide an incentive (sticks and carrots) for states to redirect non-need merit aid to need-based grants. We need to focus on on those students for whom the funds will make the difference in their decision of whether or not to attend college.
Rhonda Vonshay Sharpe, Research Director for the The Research Network on Racial and Ethnic Inequality at Duke University:
Does anyone even know what "more affordable" means? It is important to remember that taxpayers are not a homogeneous group. So I can imagine that some high earning taxpayers (often mistaken for the middle class) see public colleges in the same way they see public K-12 schools - make them better and more competitive so that I am not "taxed" twice to educate my child. As for moving resources away from low-income students to wealthy students, one could argue that it is a return on investment decision. The value added to the low-income child, even if they don't graduate, may be higher than the value added to the wealthy child. But the wealthy child is more likely, and their parents probably have resources now, to make gifts to the college.
Zakiya Smith, former White House Senior Policy Advisor for Education:
What if the federal government incented states to ensure that at least public college financial aid was going to low-income students? States that did a better job could get more federal aid, or perhaps colleges that skew their aid to more low-income students could get bigger breaks on some regulatory burdens?...some of the nation's most elite colleges ONLY give need based aid. But, they have big endowments and aren't in competition with anyone else. Places like Berea college in Kentucky are totally free to all students and have a high proportion of Pell eligible students. The data available on the College Navigator that ProPublica used to identify these negative trends could also be used to identify colleges that are doing this the right way.
I think the ratings system recently proposed by President Obama would actually discourage, rather than encourage, this sort of behavior, because it would (he says) be based on the value-add of college and include factors such as how well they serve low-income students. That would discourage colleges from creaming top kids and provide incentives for them to recruit and successfully serve more disadvantaged students. Of course, designing the right weights/measures/etc is difficult, but it seems like we all acknowledge that the current institutional prestige incentives are doing us no favors.
What do you think? Share your thoughts in the comments below.
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