WHITE PLAINS — After nearly 20 months of buildup, the misdemeanor trial of Kerry Kennedy ended on Friday in a breakneck blur, as jurors took one hour to find her not guilty of driving under the influence of a drug.
The five-day trial, which featured a riveting turn on the witness stand by Ms. Kennedy, 54, was centered on an act that neither she nor prosecutors dispute: On July 13, 2012, she drove her Lexus S.U.V. erratically after swallowing Zolpidem, a generic form of the sleep medication Ambien. She sideswiped a tractor-trailer on a highway in Westchester County before she was found, slumped over her steering wheel, her car stalled on a local road.
Ms. Kennedy has maintained that she took the pill accidentally, mistaking it for medication she took for a thyroid condition. She testified on Wednesday that she did not realize her mistake until well after the accident
The Food and Drug Administration proposed several changes to the well-known label.
CURRENT LABEL
PROPOSED REDESIGN
The redesign would change how serving sizes are calculated and displayed.
Calorie counts would be more prominent, and the existing “Calories from Fat” line would be removed.
Percent daily valueswould shift to the left, making them easier to read. Some package sizes would be required to show both “per serving” and “per package” calorie and nutrition counts.
The new design would require information about added sugars.
Vitamin D andpotassium counts would be required. Vitamins A and C would be optional.
A little over a year after Colorado and Washington legalized marijuana, more than half the states, including some in the conservative South, are considering decriminalizing the drug or legalizing it for medical or recreational use. That has set up a watershed year in the battle over whether marijuana should be as available as alcohol.
Demonstrating how marijuana is no longer a strictly partisan issue, the two states considered likeliest this year to follow Colorado and Washington in outright legalization of the drug are Oregon, dominated by liberal Democrats, and Alaska, where libertarian Republicans hold sway.
Acetaminophen has been accumulating some evidence against its routine use in recent years, and now there may be more: The drug, if used during pregnancy, may raise the risk of behavior problems in the children years later. The authors of the new study, out in the journal JAMA Pediatrics, say it’s too early to make any new recommendations for the public just yet. But since the results do suggest that prenatal use may as much as double the risk of behavior disorders in the child, pregnant women may want to take the study into consideration, or talk with their doctors.
The study followed over 64,000 families in the Danish National Birth Cohort. The mothers filled out questionnaires regarding the frequency of their acetaminophen use during pregnancy, and answered questions about various aspects of their children’s behavior. Official diagnoses of hyperkinetic disorder (HKD), a severe form of ADHD, were tracked, as well as the number of prescriptions for ADHD medications (e.g. Ritalin).
Just over half the women taking part in the study used acetaminophen during pregnancy.
Use of the drug was strongly linked to increased risk for ADHD in the children in the first seven years of life, an increase of as much as 30%. Acetaminophen was also linked to a 37% greater risk for having an HKD diagnosis. And the more often the pregnant mothers used the drug, the higher their children’s risk of behavioral problems.
“When women reported having used acetaminophen for 20 or more weeks during pregnancy, the risk for HKD diagnosis in children almost doubled,” the authors write. And the odds of the children being prescribed an ADHD medication rose by 50%.
The results held up even when factors like maternal mental health, inflammation, and infection during pregnancy were accounted for.
Acetaminophen can cross the placenta, making its way to the fetus and its delicate developing nervous system. The drug is a known endocrine (hormone) disrupter, and has previously been linked to undescended testes in male infants. Since the maternal hormone environment plays a critical role in the development of the fetus, the authors say that it’s “possible that acetaminophen may interrupt brain development by interfering with maternal hormones or via neurotoxicity such as the induction of oxidative stress that can cause neuronal death.”
All this said, causation can’t be determined from the current study – there is only a correlation between a mother’s acetaminophen use and behavioral/attention problems in the child. So there could be another factor or multiple factors at play, which haven’t been teased apart yet. And behavioral and attention problems are likely to have multiple causes, both genetic and environmental. For these reasons, the authors say that it’s too early to make any specific recommendations for pregnant women just yet.
But, they add, if causation should some day be demonstrated, then “acetaminophen should no longer be considered a safe drug for use in pregnancy.”
The authors of an accompanying editorial also point out that the results “underline the importance of not taking a drug’s safety during pregnancy for granted.” More research, they urge, will certainly be needed to address the remaining questions.
In the meantime, it may be wise to cut down on acetaminophen if you’re pregnant – it certainly shouldn’t be used routinely or for long periods. But talk with your doctor if you have questions about this, or any medications you’re taking.
This is MORNING EDITION from NPR News. I'm Renee Montagne.
DAVID GREENE, HOST:
And I'm David Greene, good morning.
The Food and Drug Administration is under enormous pressure to change its mind about a powerful new prescription painkiller. Forty-two public health groups are urging the FDA to withdraw its support of Zohydro. The drug is similar to Oxycontin, except it comes in significantly higher doses. The FDA approved Zohydro last year, despite its own advisory panel voting against it and critics are, among other things, raising questions about that approval process.
NPR's Laura Sullivan reports.
LAURA SULLIVAN, BYLINE: When Zohydro is released next month, it will be one of the most powerful prescription painkillers on the market. It's highest dosage will contain five to 10 times as much hydrocodone as the widely used Vicodin. The drug company's literature says an adult could overdose on two capsules. A child could die from swallowing just one pill.
DR. MICHAEL CAROME: People are going to die from this drug.
SULLIVAN: Dr. Michael Carome is the director of Health Research for Public Citizen.
CAROME: We are in the midst of a public health crisis. There is an epidemic of opioid addiction resulting in thousands of deaths. And the last thing we need now is another high-potent, high-dose, long-acting opioid drug, Zohydro, that will simply feed the epidemic.
SULLIVAN: Overdose deaths and addiction rates from prescription painkillers similar to Zohydro have grown dramatically in recent years. Carome and 41 other healthcare advocates are asking the FDA to remove its approval of the drug. Zohydro is a crushable pill. That means it's snortable and, some experts say, more prone to abuse than other drugs like the new versions of Oxycontin, which are no longer crushable. The drug company Zogenix is marketing the drug.
DR. BRAD GALER: There's a lot of misinformation being put out there by people who don't have all the facts.
SULLIVAN: Dr. Brad Galer is the company's chief medical officer. He says they will introduce a non-crushable version of Zohydro in three years. And the company will closely monitor prescription transfer abuse. But he says millions legitimately need this drug.
GALER: We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones - it's a very significant medical health problem that is being ignored.
SULLIVAN: That argument isn't sitting will with public health advocates. Dr. Andrew Kolodny is chief medical officer at the Phoenix House Foundation.
DR. ANDREW KOLODNY: We have many opiate formulations on the market. There's absolutely no need for a new opioid formulation.
SULLIVAN: FDA's own advisory panels seem to agree. The panel voted 11-to-2 not to approve the drug. Then in November, top FDA officials overruled that panel. And that's where things get complicated. Last fall, a series of emails were made public from a Freedom of Information Act request. They were emails between two professors who had, for a decade, organized private meetings between FDA officials and drug companies who make pain medicine. The drug companies pay the professors thousands of dollars to attend.
And here's what has critics concerned. One of those companies was Zohydro's original manufacturer, Elan Corporation. Zogenix wasn't in the picture yet but went on to partner with Elan.
Dr. Kolodny of Phoenix House Foundation.
KOLODNY: When those emails surfaced, I think for many of us there was a sense of a-ha.
SULLIVAN: Elan has a new owner and the company did not respond to requests for comment.
In a statement, the FDA said the meetings did not address specific drugs and that the FDA took part to develop better research methods. The statement says those research methods may have benefitted companies making pain drugs but that they also benefitted patients.
Zohydro's Dr. Galer attended the meetings when he worked for another drug company.
GALER: Those actually were looking at old studies to improve patient care.
SULLIVAN: So I asked him: But if the drug manufacturers are sitting in a room with FDA officials talking about pain drugs, and they're there because they spent 20 to 30 thousand dollars to be in the room, and some of the other advocates aren't allowed in that room at the same time, does that raise any concerns for you that that could be a conflict of interest?
GALER: Well, again, I'm here as chief medical officer for Zogenix. Zogenix was not involved whatsoever. All I can say is that this medication, Zohydro ER, will benefit many patients.
SULLIVAN: But police agencies are worried.
MAJOR JASON BOGUE: It's a problem we're trying to get ahead of because we know its coming.
SULLIVAN: Major Jason Bogue runs the Narcotics Division of the Prince George's County Police Department in Maryland. He's been battling prescription drug abuse and its crime, violence and addiction. He doesn't want to battle Zohydro.
BOGUE: The impact that has on society, the impact that it has on families, it's catastrophic. I can see this compounding that problem.
SULLIVAN: Attorneys general from 28 states have already asked the FDA to reconsider its approval. But in its statement, the agency said, the data shows the drug is safe, effective and needed.
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I am the 70s child of a health nut. I wasn’t vaccinated. I was brought up on an incredibly healthy diet: no sugar til I was one, breastfed for over a year, organic homegrown vegetables, raw milk, no MSG, no additives, no aspartame. My mother used homeopathy, aromatherapy, osteopathy, we took daily supplements of vitamin C, echinacea, cod liver oil. I had an outdoor lifestyle; I grew up next to a farm, walked everywhere, did sports and danced twice a week, drank plenty of water. I wasn’t even allowed pop; even my fresh juice was watered down to protect my teeth, and I would’ve killed for white, shop-bought bread in my lunch box once in a while and biscuits instead of fruit like all the other kids. We only ate (organic local) meat maybe once or twice a week and my mother and father cooked everything from scratch – I have yet to taste a Findus crispy pancake and oven chips were reserved for those nights when mum and dad had friends over and we got a “treat.”
As healthy as my lifestyle seemed, I contracted measles, mumps, rubella, a type of viral meningitis, scarlatina, whooping cough, yearly tonsillitis, and chickenpox, some of which are vaccine preventable. In my twenties I got precancerous HPV and spent 6 months of my life wondering how I was going to tell my two children under the age of 7 that mummy might have cancer before it was safely removed.
So having the “natural immunity sterilised out of us” just doesn’t cut it for me. How could I, with my idyllic childhood and my amazing health food, get so freaking ill all the time? My mother was the biggest health freak around–she would put most of my current “crunchy” friends to shame. She didn’t drink, she didn’t smoke, she didn’t do drugs and we certainly weren’t allowed to watch whatever we wanted on telly or wear plastic shoes or any of that stuff. She LIVED alternative health. And you know what? I’m glad she gave us the great diet that we had, I’m glad that she cared about us in that way.
But it just didn’t stop me getting childhood illnesses.
My two vaccinated children, on the other hand, have rarely been ill, have had antibiotics maybe twice in their lives, if that (not like me who got so many illnesses which needed treatment with antibiotics that I developed a resistance to them, which led me to be hospitalized with penicillin-resistant quinsyat 21–you know that old fashioned disease that killed Queen Elizabeth I and which was almost wiped out through use of antibiotics).
My kids have had no childhood illnesses other than chickenpox, which they both contracted while still breastfeeding. They too grew up on a healthy diet, homegrown organics etc. Not to the same extent as I did, though, as I was not quite as strict as my mother, but they are both healthier than I have ever been.
I find myself wondering about the claim that complications from childhood illnesses are extremely rare but that “vaccine injuries” are rampant. If this is the case, I struggle to understand why I know far more people who have experienced complications from preventable childhood illnesses than I have EVER met with complications from vaccines. I have friends who became deaf from measles. I have a partially sighted friend who contracted rubella in the womb. My ex got pneumonia from chickenpox. A friend’s brother died from meningitis.
Anecdotal evidence is nothing to base decisions on. But when facts and evidence-based science aren’t good enough to sway someone’s opinion, then this is where I come from. After all, anecdotes are the anti-vaccine supporter’s way. Well, this is my personal experience. And my personal experience prompts me to vaccinate my children and myself. I got the flu vaccine recently, and I am getting the whooping cough booster to protect my unborn baby. My natural immunity from having whooping cough at age 5 will not protect him once he’s born.
I understand, to a point, where the anti-vaccine parents are coming from. Back in the 90s when I was a concerned, 19-year-old mother, frightened by the world I was bringing my child into, I was studying homeopathy, herbalism and aromatherapy; I believed in angels, witchcraft, clairvoyants, crop circles, aliens at Nazca, giant ginger mariners spreading their knowledge to the Aztecs, the Incas and the Egyptians and that I was somehow personally blessed by the Holy Spirit with healing abilities. I was having my aura read at a hefty price and filtering the fluoride out of my water. I was choosing to have past life regressions instead of taking anti-depressants. I was taking my daily advice from tarot cards. I grew all my own veg and made my own herbal remedies. I was so freaking crunchy that I literally crumbled. It was only when I took control of those paranoid thoughts and fears about the world around me and became an objective critical thinker that I got well. It was when I stopped taking sugar pills for everything and started seeing medical professionals that I began to thrive physically and mentally.
If you think your child’s immune system is strong enough to fight off vaccine-preventable diseases, then it’s strong enough to fight off the tiny amounts of dead or weakened pathogens present in any of the vaccines. But not everyone around you is that strong, not everyone has a choice, not everyone can fight those illnesses, and not everyone can be vaccinated. If you have a healthy child, then your healthy child can cope with vaccines and can care about those unhealthy children who can’t. Teach your child compassion, and teach your child a sense of responsibility for those around them. Don’t teach your child to be self serving and scared of the world in which it lives and the people around him/her. And teach them to LOVE people with ASD or any other disability for that matter, not to label them as damaged.
And lastly but most importantly for me – knowingly exposing your child to childhood illnesses is cruel; even without complications these diseases aren’t exactly pleasant. I don’t know about you, but I don’t enjoy watching children suffer even with a cold or a hurt knee. If you’ve never had these illnesses you don’t know how awful they are–I do. Pain, discomfort, the inability to breathe or to eat or to swallow, fever and nightmares, itching all over your body so much that you can’t stand lying on bed sheets, losing so much weight you can’t walk properly, diarrhea that leaves you lying prostrate on the bathroom floor, the unpaid time off work for parents (and if you’re self employed that means NO INCOME), the quarantine, missing school, missing parties, the worry, the sleepless nights, the sweat, the tears and the blood, the midnight visits to A and E, sitting in a doctor’s waiting room on your own because no one will sit near you because they’re rightfully scared of those spots all over your kids face.
Those of you who have avoided childhood illnesses without vaccines are lucky. You couldn’t do it without us pro-vaxxers. Once the vaccination rates begin dropping, the less herd immunity will be able to protect your children. The more people you convert to your anti-vax stance, the quicker that luck will run out.
SOCHI, Russia — Nicklas Backstrom, a player for the Washington Capitals in the N.H.L. who represented Sweden in its five victories on the way to the Olympic gold medal game, failed a drug test at the Sochi Games. He was removed from Sweden’s lineup Sunday before the final, which Canada won, 3-0.
Backstrom, 26, had tested positive for pseudoephedrine, a substance found in an allergy medication he has taken for seven years.
MEXICO CITY — Just before 7 a.m. on Saturday, dozens of soldiers and police officers descended on a condominium tower in Mazatlán, Mexico, a beach resort known as much as a hangout for drug traffickers as for its seafood and surf.
The forces were following yet another tip about the whereabouts of one of the world’s most wanted drug kingpins, Joaquín Guzmán Loera — known as El Chapo, which means “Shorty” — who had eluded such raids for 13 years since escaping from prison, by many accounts in a laundry cart. With an army of guards and lethally enforced loyalty, he reigned over a worldwide, multibillion-dollar drug empire that supplied much of the cocaine and marijuana to the United States despite a widespread, years long manhunt by American and Mexican forces.
Mr. Guzmán’s Sinaloa Cartel is considered the largest and most powerful trafficking organization in the world, with a reach as far as Europe and Asia, and has been a main combatant in a spasm of violence that has left tens of thousands dead in Mexico.
But it was the forces under the control of President Enrique Peña Nieto, whose resolve to fight drug traffickers was questioned, that produced the biggest arrest in a generation. While Mr. Peña Nieto has not allowed American law enforcement officials the kind of broad access in Mexico that Mr. Calderón had permitted, the two countries have continued to work together on big cases.
It remains to be seen if the arrest will interrupt Mexico’s thriving drug trade. The capture or killing of a drug lord sometimes unleashes more violence as internal feuds break out and rivals attack.
But in the end, he was captured not long after doing what so many cartel bosses do: having a party in Mazatlán.
The authorities seized an arsenal during his arrest, suggesting the lengths he went to protect himself: 97 large guns, 36 handguns, 2 grenade launchers, a rocket launcher, and 43 vehicles, several of them armored.
Mr. Guzmán had seven houses, with reinforced steel doors and connected by tunnels that allowed him time to escape just ahead of the police.
The D.E.A. assisted Mexican agents arrested several security people for Mr. Guzmán and discovered the tunnels, with openings to them in the showers of several homes.
Mr. Guzmán fled to Mazatlán, the official said, and the Mexicans and Americans followed.
As it became apparent that Mr. Guzmán had been caught, some in Mazatlán, where he had been known to dole out wads of cash to keep his whereabouts secret, expressed concern. At a breakfast gathering for local businessmen, a few attendees got up and left immediately, according to a witness.
In the years since he escaped prison, Mr. Guzmán took on near-mythic status. He landed on the Forbes list of the world’s richest people. He picked up the tab for entire restaurants, or so the stories go, to ensure diners would remain silent about his outings. According to a leaked diplomatic cable, he surrounded himself with an entourage of 300 armed men for protection. And narcocorridos, folk ballads in tribute to drug lords, were sung in his honor.
Mr. Guzmán was born in poverty in the foothills of the Sierra Madre in Sinaloa State and dropped out of school by third grade.
NOGALES, Ariz. — Tom Pittman has made a career as a Border Patrol agent here guarding this city’s underground drainage system, where the tunnels that carry sewage and storm runoff between the United States and Mexico are also busy drug-smuggling routes. Over the years, he has crawled and slithered past putrid puddles, makeshift latrines and discarded needles left behind by drug users, relying on instincts, mostly, to gauge the risks ahead.
It is a dirty and dangerous business, but these days, there is a robot for that.
Three robots, out of four in use by the agency along the entire southern border, are newly assigned to the Border Patrol station here. The reason is in the numbers: Most of the tunnels discovered along the border lead from Nogales, Mexico, to Nogales, Ariz., out of sight of the agents, cameras and drones that blanket the ground above. This month, federal agents closed the largest one found so far, a 481-foot passageway aired by fans and lit by lamps hanging from wires that ran along the tunnel’s walls.
The robots are just the latest tactic in a vexing battle by the federal authorities to try to stem the flow of drugs through the tunnels, considered prime pieces of real estate by the smuggling groups that build and control them. Border Patrol agents have tried dumping concrete inside the tunnels to render them unusable, and installing cameras and motion detectors to alert them of suspicious movement underground. But still the tunnel diggers persist.
The robots, valued for their speed and maneuverability, can serve as the first eyes on places considered too risky for humans to explore.
“If anyone is going to get hurt, it better be that robot,” said Mr. Pittman, a supervisory agent here.
The tunnels are part of a sophisticated enterprise. The groups that control the smuggling routes in the Mexican Nogales — the Sinaloa cartel on the east side of the city, the Beltrán-Leyva cartel on the west — have an understanding: One side pays the other to use the areas it holds, both “above ground and underground,” said Special Agent Alex Garcia of Homeland Security Investigations, who leads the border tunnel task force here.
Many of the tunnel diggers are believed to come from the copper mines of Cananea, Mexico, about 45 miles southeast of Nogales. They use tools with short handles because, in the tunnels here, there is no room to stand up straight, Mr. Garcia said.
That does not bother the tunnel-detecting robots. They have cameras that look up, down and sideways, in front of them and behind them. Controlled remotely by joysticks, they glide, bump and scrape along dark, cramped areas, where the air is not safe for humans to breathe for long. One model sounds and looks like the remote-controlled Humvees sold in toy stores. The other, with its bullet-shaped body and shiny blue and silver shell, seems as if it had been pulled right off a sci-fi movie set.
To get ready for this work, the human agents “have to put on kneepads, elbow pads — we’ve got to put on helmets, gloves,” said Kevin Hecht, the deputy patrol agent in charge of the Border Patrol station in Nogales and one of the agency’s foremost experts on illicit tunnels. “Sometimes we have to put on Tyvek suits,” he said, referring to the coveralls that protect against the hazards that can lurk below drainage lines.
The robots, on the other hand, need no preparation other than the flick of a switch.
“At any given moment, there’s a tunnel being planned, under construction or in operation in and around this city,” Mr. Balliet said.
The large tunnel found here this month linked an abandoned home in Mexico to an occupied house not far from the border. The drugs were taken from there in hollowed-out couches or inside washing machines, according to the criminal complaint; three men were arrested on drug-conspiracy charges.
Many of the tunnels that are found end in inconspicuous places like this. One of them, discovered in December, exited into a backyard shed. Another, found last February, ended at an embankment behind the border fence, near a spot where a different tunnel had been closed in March 2012.
Nogales, Ariz., recently banned parking on a section of International Street, which runs parallel to the fence, after a tunnel exit was found there, less than 100 feet from a border crossing. Smugglers inside the tunnel had used a jackhammer to raise a piece of concrete cut from the pavement. Then they pushed bales of marijuana through the fake bottom of a refrigerated truck parked right above the hole.