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War Studies Suggest A Concussion Leaves The Brain Vulnerable To PTSD

NPR Health Blog - 6 hours 9 min ago
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September 26, 20164:39 AM ET Heard on Morning Edition

Charles Mayer, 30, of San Diego, survived an IED attack while serving in Iraq in 2010, but has suffered from complications including PTSD.

Stuart Palley for NPR

There's growing evidence that a physical injury to the brain can make people susceptible to post-traumatic stress disorder.

Studies of troops deployed to Iraq and Afghanistan have found that service members who suffer a concussion or mild traumatic brain injury are far more likely to develop PTSD, a condition that can cause flashbacks, nightmares and severe anxiety for years after a traumatic event.

And research on both people and animals suggests the reason is that a brain injury can disrupt circuits that normally dampen the response to a frightening event. The result is like "driving a car and the brake's not fully functioning," says Minxiong Huang, a biomedical physicist at the University of California, San Diego.

Scientists have suspected a link between traumatic brain injury (TBI) and PTSD for many years. But the evidence was murky until researchers began studying troops returning from Iraq and Afghanistan.

What they found was a lot of service members like Charles Mayer, an Army sniper from San Diego who developed PTSD after finishing a deployment in Iraq.

In 2010, Mayer was on patrol in an Army Humvee near Baghdad when a roadside bomb went off. "I was unconscious for several minutes," he says. So he found out what happened from the people who dragged him out.

The blast fractured Mayer's spine. It also affected his memory and thinking. That became painfully clear when Mayer got out of the Army in 2012.

Charles (right) gets tutoring from his brother, David, on the GRE test at their parents' home. The couch in the living room bears a blanket with images of the three Mayer brothers.

Stuart Palley for NPR

"Two weeks later I started school," he says. "And a simple math equation like 120 times 7, where I previously would do that in my head very easily, I all of a sudden couldn't do that."

And Mayer had a bigger problem. His time in Iraq had left him with an uncontrollable fear of improvised explosive devices, or IEDs.

"When I would walk down the street, I would walk away from trash piles because that's often how they would hide IEDs," he says. "I stayed away from large crowds."

Mayer's fear was not only disturbing, it was disabling. "I would get severe panic attacks to the point where I would have to go to the hospital," he says. "I would feel like I'm actually having a heart attack."

Eventually, Mayer went to a Veterans Affairs hospital for help. An exam confirmed that he had PTSD.

The wars in Iraq and Afghanistan have produced thousands of Charles Mayers. First they got a concussion from a bomb blast. Then they got PTSD.

"We had people who were looking very miserable when they came back," says Dewleen Baker, a psychiatrist at UCSD and the VA San Diego Healthcare System.

Baker kept asking herself: Was the PTSD just from the emotional trauma of combat? Or did a concussion alter the brain in a way that amplified fear and anxiety?

"I could easily diagnose the PTSD," she says. "But I found it very, very difficult to tease apart the contribution of traumatic brain injury."

Mayer in Iraq in 2010, where he served as a sniper and was injured in a roadside explosion.

Courtesy of Charles Mayer

So Baker and a team of researchers began studying more than 1,600 Marine and Navy service members from Camp Pendleton, in San Diego County, Calif. The service members had been assessed before deploying to Iraq or Afghanistan, and then again three months after returning.

"At one point we got this battalion that went to Helmand Province in Afghanistan and literally 50 percent of them were complaining of blast exposures and symptoms," Baker says. "I got concerned."

Baker had reason to worry. The study found that troops who experienced a traumatic brain injury were twice as likely to develop post-traumatic stress disorder.

But why? There was no easy way to answer that question in people. But several years ago some answers began to emerge from animal studies.

In one experiment, a team of scientists at the University of California, Los Angeles compared healthy rats with rats that had experienced a traumatic brain injury. All of the rats received a type of behavioral conditioning known to induce fear.

They found that fear response learned by the animals that had experienced a TBI was much greater than it normally would be, says Fanselow Michael, a psychology professor at UCLA and an author of the study.

Next, the team looked at cells in the amygdala, a part of the brain that takes sensory information and decides whether to be afraid. They found changes that would amplify the animal's response to a frightening experience.

"And we think that that's the way TBI has of increasing your susceptibility to post-traumatic stress," Fanselow says.

If brain injuries really do change the brain's fear circuitry, there should be some way to detect that change in people, says Baker.

So Baker teamed up with her colleague Minxiong Huang, the biomedical physicist. Huang has been using a technology that measures electrical activity in the brain. It's called magnetoencephalography,or MEG.

Huang and a team of researchers used MEG to scan the brains of 84 people who'd experienced a brain injury. Some of the participants were service members, some were civilians.

Those scans found abnormal signals coming from the brains of people who'd had a concussion. And the location of those abnormal signals suggested that there was too much activity going on in the amygdala and not enough in an area that normally tempers emotional reactions.

The result is a brain that is "like a car with no brake," Huang says.

After leaving the Army and starting school, Charles discovered he could no longer do simple math equations in his head.

Stuart Palley for NPR

To learn more about the brain circuitry involved in both TBI and PTSD, Dewleen Baker is expanding her earlier study of Marines. She plans to scan the brains of about 200 combat veterans, including some with both TBI and PTSD.

And Baker will have help from a researcher with a personal stake in the project: Charles Mayer, the former soldier whose college career was interrupted by PTSD.

After getting treatment, Mayer was able to finish his undergraduate degree in December. Then Mayer, who is now 30, started looking for a job that would let him study the problems that had affected his own brain.

"I looked up the psychiatrists that were doing research that I really cared about, and Dr. Baker was definitely up there," he says. And Baker hired him.

Their research will focus on veterans. But the findings could also help identify civilians who've suffered a brain injury that could make them vulnerable to PTSD.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Deadly Opioid Overwhelms First Responders And Crime Labs in Ohio

NPR Health Blog - Sun, 09/25/2016 - 8:35am
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September 25, 20168:35 AM ET Heard on Weekend Edition Sunday

From Side Effects Public Media

Bob Topmiller, chief of toxicology at the Hamilton County Coroner's Office, holds a small vial containing carfentanil extracted from a sample of blood.

Jake Harper/Side Effects Public Media

Jamie Landrum has been a police officer for two years in District 3 on the west side of the Cincinnati. In late August, the city was hit by 174 overdoses in six days. Landrum says officers were scarce.

"We were literally going from one heroin overdose, and then being on that one, and hearing someone come over [the radio] and say, 'I have no more officers left,' " Landrum says. Three more people overdosed soon after that.

Heroin isn't new in Cincinnati, but the recent surge in overdoses is being blamed on an even more potent drug called carfentanil. It's 100 times stronger than fentanyl, a more common synthetic opioid that is itself much stronger than heroin. Carfentanil is used to sedate elephants. It can be dangerous to even touch it without gloves.

City and county agencies in the Cincinnati area — from law enforcement to the county coroner — are straining to respond to the carfentanil wave.

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Carfentanil is part of a shift to synthetic opioids in Cincinnati and around the country. Last year in Hamilton County, Ohio, there were more deaths attributed to fentanyl than to heroin.

Suspected carfentanil cases were first reported in the U.S. in July in Ohio. The rate of overdoses has dropped since that shocking 174 in six days, but not by much. There are currently 20 to 25 overdoses a day, on average, reports Hamilton County's heroin task force. Police are calling it the new normal.

About an hour into a recent shift, Officer Landrum gets a call. A man has overdosed at an apartment building on the outskirts of town. His girlfriend found him and called 911.

By the time we get there, there's a crowd outside. The man is unconscious in the back of the ambulance, and EMTs have given him three doses of Narcan, an antidote for opioid overdose. For a heroin overdose, one round of Narcan is usually enough.

EMTs clap and shout his name, trying to wake him up, but something's wrong. They turn off the music blaring in the ambulance and continue working. After a few minutes, Officer Landrum gives me an update.

"This is the most I've ever seen," she says. "He's gotten four Narcans so far, and he's still not awake."

The EMTs decide to take him to the hospital. We follow, not knowing if the man will make it. "Whatever he got ahold of, it's really bad," Landrum says.

For first responders, the arrival of carfentanil can be summed up with one word: More. More overdoses, more Narcan, more time spent on each call.

And when the efforts to save someone's life fail, more work gets passed on to the Hamilton County Coroner's Office.

"The caseload keeps getting larger and larger," says Bob Topmiller, who heads the toxicology section at the coroner's office, where they test blood and urine. "We may have had a 100- or 150-case backlog a year ago, and it's almost doubled." The time it takes to process a sample has also doubled, from one month to two.

Evidence of the deluge is all over the lab: Equipment spills into the hallways, envelopes cover the intake desk, and everyone seems to be busy.

And it's more than the number of cases causing the flurry of activity. It's the fact that the drug was never meant for people.

"It's what we don't know about this drug that scares us," says Dr. Lakshmi Sammarco, the coroner for Hamilton County. "We don't have any human testing data. We don't know what the lethal level really is. There is no therapeutic level — it's not meant for human use."

Dr. Lakshmi Sammarco, the coroner for Hamilton County, Ohio, worries about the paucity of information about how carfentanil, an animal drug, affects humans.

Jake Harper/Side Effects Public Media

That means Sammarco's team is using the samples coming in to try to extrapolate some important information, like the lethal dose per kilogram of body weight, or how long carfentanil stays in someone's system — things that could help the people treating the overdoses.

Sammarco says this process is part of a pattern they've dealt with before, playing catch up with the suppliers as new drugs appear.

"However, in the spectrum of opiates, this is about max," she says. "Out of all of them, carfentanil really is the most potent."

For now, Sammarco can only say that there have been eight deaths in which carfentanil might be the cause. Her office is working to test samples dating back to July, when the drug first showed up in Ohio.

At the hospital, Landrum follows the overdose victim into the emergency room. After about half an hour, doctors and nurses stabilize him.

We leave after that. The man didn't have any drugs on him, so he wasn't charged with any crime. His girlfriend wouldn't say where the drugs came from, though she did mention that the two of them had overdosed the week before.

"Believe it or not, we'll probably be responding out for her here shortly," says Landrum. Even after close calls, people keep using. Addiction is too strong.

What's worse, the danger of carfentanil seems to act as an advertisement: People seem to equate near death with a really good high, and the problems in Cincinnati are attracting customers. Landrum says recently she met a couple from Indianapolis in town to buy drugs. Another officer talked to people from central Kentucky.

So far, the DEA says carfentanil has only been confirmed in Ohio and Kentucky. Other states are starting to test for it, bracing for its arrival.

This story is part of a reporting partnership with NPR, Side Effects Public Media and Kaiser Health News.

Copyright 2016 Side Effects Public Media. To see more, visit Side Effects Public Media.
Categories: NPR Blogs

Controversy Continues Over Muscular Dystrophy Drug, Despite FDA Approval

NPR Health Blog - Sat, 09/24/2016 - 8:47am
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September 24, 20168:47 AM ET Heard on Weekend Edition Saturday

Duchenne muscular dystrophy patients Jack Willis (center), Nolan Willis (right) and Max LeClaire, attended the opening of Sarepta Therapeutics new headquarters in Cambridge, Mass., in 2014.

Boston Globe via Getty Images

When 15-year-old Billy Ellsworth stepped up to the microphone at a Food and Drug Administration public meeting in April, he had no way to know he was part of a historic shift in how the government considers the desires of patients and their advocates in evaluating new drugs.

Ellsworth has Duchenne muscular dystrophy, a muscle-wasting disease, that mainly affects boys. And he was taking an experimental drug that the FDA was trying to decide whether to approve.

"I'm going to beat this bloody disease but I need your help," Billy told the scientists weighing the evidence about the drug. "So please help me and my friends and do the right thing. FDA, please don't let me die early."

Applause swelled from the overflow crowd.

His testimony and other pleas like it during the 10-hour hearing clearly affected some of the scientists sitting in judgment of the experimental drug called eteplirsen. But when the scientists turned their attention to the slim evidence before them, they ultimately voted that drugmaker Sarepta had not shown that the experimental drug was effective.

Just 12 boys had been involved in the key study, and just about everybody agreed that the research was deeply flawed. But parents of some of those boys were convinced that the drug was in fact helping delay the progression of a disease that ultimately proves fatal.

"We came away really heartbroken in many ways," said Pat Furlong, a longtime advocate who founded Parent Project Muscular Dystrophy and who had lost two sons to the disease.

One similar drug had previously been rejected by the FDA, and two others were turned away before they could even get through the door. There was no approved drug to stop the progression of this disease.

But that wasn't the end of the story.

Times are changing at the FDA and other federal agencies. In recent years, legislation and regulation has pushed for a greater patient voice in decisions. The FDA's job wasn't simply to look at the science, as it has done for many years. They have "to look to what is meaningful benefit on the part of the patients," Furlong said. "What do the patients value?"

In this case, the parents were saw real promise in this drug, despite the results from the flawed study. They also noted that the drug appears to be safe, so there wasn't much risk. And the research did show that boys on the drug were producing a small amount of a potentially helpful protein called dystrophin, which could be a sign that the drug provides some benefit.

That was all part of the FDA's thinking when on Monday it approved eteplirsen, brand name Exondys 51, on a provisional basis. A letter written by FDA Commissioner Robert Califf laid out in remarkably frank terms the heated internal debate at the agency, which may have led to the departure of one key scientist who was opposed to approving the drug.

"It is inevitable that in some of these situations, highly qualified experts will disagree," Califf wrote, and he praised Dr. Janet Woodcock, the head of the FDA division that reviews new drugs, who made the call "in the face of profound changes in science and social interactions related to drugs."

Califf said Woodcock ultimately made a scientific judgment call, anchored on the observation that the drug does prompt patients to produce at least a small amount of dystrophin.

Yet the role of advocacy here was inescapable. It is, after all, the patients who face the risks and the benefits.

"You can look at this as being a potentially damaging precedent, and on the other hand you can look of this as being an innovative precedent, that could bring good things and earlier access to medicines," Eric Hoffman told NPR.

Hoffman and Louis Kunkel discovered the dystrophin gene in 1987. Hoffman is now CEO of ReveraGen, a company working on a drug for the disease, as well as associate dean of research at the University of Binghamton's pharmacy school in New York.

The FDA decision approves the drug on an accelerated basis, but that approval is contingent on follow-up studies and it can be withdrawn. In other diseases, provisional approvals have been reversed after follow-up studies failed to show the drugs were effective. (Avastin for advanced breast cancer is a notable example, despite pleas from patient groups to keep the approval intact).

The Sarepta drug addresses just one genetic mutation in muscular dystrophy, and that particular flaw only affects about 1,500 boys in the entire United States. Drugmaker Sarepta plans to use the same approach now to target other mutations related to the disease, and to use those study results to comply with the FDA's requirement for more and better studies.

In the meantime, Sarepta can start charging $300,000 per patient per year for treatment with eteplirsen.

"Yes, there was a lot of pressure," Dr. Edward Kaye, CEO of Sarepta said, "but I think the FDA demonstrated the flexibility they are allowed under the law. It took a lot of courage for them to do this. It's always easy to take the safe path and say, just give us more data."

Advocate Pat Furlong agreed. "I think the important aspect of this is maybe a new social contract," she said. Since the drug is apparently safe and possibly useful, parents wanted to make the drug available while the questions about usefulness and value are fully answered. "And at the end of five years we can reevaluate whether this really hits its mark in terms of the healthcare cost and the benefit to patients," she said.

More than a dozen potential drugs for this disease are in the pipeline now, and at the very least they now have a standard against which they can be judged.

The decision about eteplirsen would have been considerably easier, for patients and scientists alike, if the company had conducted its trials carefully and rigorously.

"Considering that a substantially flawed development program contributed to the difficulty of coming to resolution in this case, we must redouble our efforts to ... use methods that will produce high-quality evidence from the outset," Califf wrote.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

This Doctor Is Trying To Stop Heart Attacks In Their Tracks

NPR Health Blog - Fri, 09/23/2016 - 1:25pm
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September 23, 20161:25 PM ET Heard on All Things Considered

Dr. Harry Selker, a cardiologist, works on collaborations to improve delivery of medical care.

M. Scott Brauer for NPR

When Harry Selker was working as a cardiologist in the 1970s, clot-busting drugs were showing great promise against heart attacks. But their life-saving properties were very time sensitive. "If you give it within the first hour it has a 47 percent reduction of mortality; if you wait another hour, it has a 28 percent reduction; another hour, 23 percent. And people were taking about 90 minutes to make that decision," he recalls. "So they were losing the opportunity to save patients' lives."

Selker envisioned a predictive tool, a kind of calculator that would help make the decision faster. He knew the data to create such a tool were already out there, from research on drugs that dissolve blood clots. "We made mathematical models and they kind of represented that comparison from those data, and that helped us make these predictive instruments. We built them into electrocardiograms," Selker says. That helped physicians make better decisions.

The EKG-based predictive instruments have helped doctors prescribe clotbusters within the hour, increasing the use of the therapy within one hour, and getting more people treated with either clotbusting drugs or angioplasty.

Building on this success, Selker and colleagues at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center in Boston, where he is executive director, have gone on to develop other predictive tools, in areas from knee replacement therapy to opioid addiction treatment.

Selker grew up in a household in the Seattle area where he was encouraged to tinker. In his office, he proudly shows off the first automobile shock absorber, invented by his grandfather.

And while Selker's own list of patents will attest to his passion for innovation, he's equally passionate about working to ensure those innovations will have an impact.

One medical treatment Selker is pursuing right now has never delivered on its early promise for saving lives. It's a cocktail of glucose, insulin and potassium, known by its chemical initials GIK. In studies with baboons and rabbits more than 50 years ago, GIK seemed to actually prevent heart attacks. "They would clamp off these coronary arteries simulating coronary thrombosis, but keep infusing them with glucose and insulin, then potassium," Selker says.

When the researchers unclamped the arteries, they found no signs of cardiac arrest, as would be expected. The simple concoction had protected heart muscles against damage. Selker says: "So it was very encouraging. It was extraordinary, really."

But there was a problem in translation: In human studies, GIK didn't seem to do much of anything to prevent heart attacks or damage. The research sat on the shelf. But when Selker learned about the research from a colleague and they started to discuss it, he became convinced there were fatal flaws in the human studies, including administering the GIK too late to have an effect. Selker and his colleagues designed a study to test GIK in humans.

Paramedics in 13 cities gave people who appeared to be having a heart attack either GIK or a placebo. The GIK didn't keep people from having heart attacks, but those given it were less likely to suffer cardiac arrest or death in the hospital. It also reduced the amount of heart damage by 80 percent. The results were published in JAMA in 2012.

Selker is testing whether a simple, cheap combination of three drugs can help reduce the damage caused by a heart attack.

M. Scott Brauer for NPR

Selker says that if additional research supports these findings, many lives could be saved with a simple therapy that costs less than a hundred bucks. But he soon discovered that knowing what needed to be done wasn't enough.

"I thought, pretty much, my work was done and people call me up and say you know, 'when would we get this GIK stuff?' And I realized nobody's making it, nobody's selling it. And so I started talking to the pharmaceutical companies saying, 'You know, would you make this stuff?' And they basically weren't interested."

GIK is a cocktail of existing off-the-shelf ingredients. A company could invest in the additional research and work to get it out to patients, but there'd be no big payoff. But Selker refuses to be deterred.

He is now in dialogue with the Food and Drug Administration about the details of a definitive clinical trial to determine the effectiveness of GIK in acute coronary emergencies. And like so many times before, he's continuing to reach across professional boundaries, working with policy experts, statistical modelers, anyone who can push the process forward.

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"If you're going to try to improve things, you have to work on all angles, you have to work in all disciplines," Selker says. "You can't just work in biology; that would never get you anywhere."

His happiest moments in research, he says, have been sitting down with people who have ideas he never could have imagined, where he gets to push and prod, challenging them to figure out how to put those ideas to use.

"So working across disciplines and personalities and in different perspectives; that's the good stuff for me. Now really that makes a great day."

Selker is hopeful that the next clinical trial for GIK will take place by early next year, moving one step closer to a tested treatment that could save lives.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Doctor Confesses: I Lied To Protect Colleague In Malpractice Suit

NPR Health Blog - Fri, 09/23/2016 - 5:00am

Dr. Lars Aanning, seen at his home outside Yankton, S.D., said he lied to protect a colleague in a malpractice case. Now, Aanning is a patient safety advocate.

Jay Pickthorn/AP for ProPublica

Almost two decades ago, Dr. Lars Aanning sat on the witness stand in a medical malpractice trial and faced a dilemma.

The South Dakota surgeon had been called to vouch for the expertise of one of his partners whose patient had suffered a stroke and permanent disability after an operation. The problem was that Aanning had, in his own mind, questioned his colleague's skill. His partner's patients had suffered injuries related to his procedures. But Aanning understood why his partner's attorney had called him as a witness: Doctors don't squeal on doctors.

The attorney asked the key question: Did Aanning know of any time his partner's work had been substandard?

"No, never," Aanning said.

Now, Aanning, in a stunning admission for a medical professional, has a blunter answer: "I lied."

While it's impossible to know to what extent Aanning's testimony influenced the outcome, the jury sided in favor of his colleague — and, ever since, Aanning said, he has felt haunted by his decision.

Now, 77 and retired, he decided to write about his choice and why he made it in a recent column for his local newspaper, The Yankton County Observer. He also posted the article in the ProPublica Patient Safety Facebook group. Aanning, who is a member, called it "A Surgeon's Belated Confession."

"From that very moment I knew I had lied — lied under oath — and violated all my pledges of professionalism that came with the Doctor of Medicine degree and membership in the [American Medical Association]," Aanning wrote.

Aanning, who has become an outspoken patient advocate, now assists the medical malpractice attorney who represented the patient in the case in which he lied for his partner.

There's no way to tell how often doctors lie to protect their colleagues, but ProPublica has found that patients frequently aren't told the truth when they are harmed. Studies also show that many physicians do not have a favorable view of informing patients about mistakes and that health care workers are afraid to speak up if things don't seem right. Many doctors and nurses have told ProPublica that they fear retaliation if they speak out about patient safety problems.

ProPublica spoke to Aanning about his unusual column and why he decided to confess all these years later. The interview has been edited for clarity and length.

Why did you tell the lie?

I did it as a matter of course. And I did it because there was a cultural attitude I was immersed in: You viewed all attorneys as a threat, and anything that you did was OK to thwart their efforts to sue your colleagues. I just accepted that as normal. It wasn't like, "I'm going to lie." It was, "I'm going to support my colleague."

Did you feel pressure from your peers to never criticize a colleague?

Pressure is the prevailing attitude of the medical profession. The professional societies like the AMA and the American College of Surgeons say you should be a patient advocate at all times. But that goes out the window because here you are, banding together with your peers. Because if you don't, you'll be like a man without a country.

Why are you telling the truth now?

I'm retired now. The big benefit is they can't hurt me, but I can't go to the clinic for any help. All my doctors are out of town. I came to America from Norway in '47 and grew up in New York. I've always been a rabble-rouser. This testifying falsely at this trial was not like me, so it stands out. It's not how I do stuff.

I also told the truth about my lie because I have been helping some of these plaintiffs' lawyers with their cases. It seems that the courtroom is not the arena for adjudication of medical right or wrong. I shared my story to give an explicit example of why you can't always rely on physician testimony in court. I think that's the big reason. There's got to be a different way to help people who have been medically harmed. Looking to the legal system is like mixing oil and water.

Do you feel like it's your fault the patient lost the case?

I haven't touched on that question. It would make it painful for me. I would be moved to tears if that whole case revolved around just my testimony. I was on the stand so briefly. But cumulatively between what I said and the other testimony — it was never a level playing field for the plaintiff. People don't recognize it. How the judges don't recognize it and the system doesn't recognize it is beyond me. It's something I'm coming to grips with.

Have you thought about talking to the patient's family?

The attorney said something about meeting the patient's widow in his office, or something like that. I worry about whether my testimony weighed on the final verdict or not. It's something that you just have to face up to. It's too late to deflect it.

Do you feel any better or worse now that you've gone public with your moral failure?

I'm not altruistic. I'm not a crusader. I got into writing this column accidentally, so I just kind of find myself in this position. I get a great satisfaction out of defining what I see and writing about it. I hope nobody's going to come back at me and accuse me of bad conduct. Although that's what it was. I felt bad about it.

ProPublica is interested in hearing from patients who have been harmed while undergoing medical care, through its Patient Harm Questionnaire and Patient Safety Facebook Group. You can follow Marshall Allen on Twitter: @marshall_allen.

Copyright 2016 ProPublica. To see more, visit ProPublica.
Categories: NPR Blogs

Are We Reaching The End Of The Trend For Longer, Healthier Lives?

NPR Health Blog - Fri, 09/23/2016 - 4:57am
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September 23, 20164:57 AM ET Heard on Morning Edition Andrew Baker/Ikon Images/Getty Images

American lives have been getting steadily longer, and since the 1960s that trend has been driven mostly by a remarkable reduction in heart disease. But those improvements have slowed dramatically. Scientists are now wondering whether we're approaching the end of the trend of longer, healthier lives.

That's because the steady decline in heart disease is fading.

Most people alive today don't remember the days when many people in their 40s and 50s would simply drop dead of a heart attack. But 79-year-old John Kenneth "Ken" Carbaugh Jr. does.

"When I was a kid a long time ago I remember a lot of people died from 'indigestion,' " he told Shots. "That's what they said it was, but that's not what it was. They were having heart attacks and they didn't even know it."

Carbaugh has lived through a remarkable period of history. During his lifetime, cardiovascular disease dropped dramatically as a cause of death. It went from killing about half of all Americans back in the 1960s, to only about one-quarter today.

Carbaugh has helped tell that success story himself. For the past 30 years he has volunteered in a study to track heart health in the United States. On the day we meet, he has driven in from his home on a country road in Washington County, Md., to Hagerstown, where he is getting a periodic exam.

The low-slung building is an outpost of the Johns Hopkins Bloomberg School of Public Health. It's right next to Antietam Creek, about 10 miles upstream from the Civil War battlefield.

Carbaugh will get a battery of tests, which will take five hours to complete. He's one of about 4,000 people here in Washington County recruited in the 1980s for this long-term study. The youngest is now 75. More than half are still alive.

This is one of four counties nationwide that has been providing a very detailed look at heart health for a federally funded study called Atherosclerosis Risk in Communities (ARIC), according to Josef Coresh, an epidemiology professor and physician at the Hopkins Bloomberg School.

Researchers in these representative counties — in Maryland, Minnesota, Mississippi and North Carolina — have been following about 16,000 volunteers since the late 1980s.

"They've been kind enough to volunteer for examinations and phone calls twice a year," Coresh says. "That means they've contributed invaluable data that will stick around forever. So ARIC [and the Framingham Heart Study] have become national resources and treasures for research."

The point of this study isn't to track the national trends in heart disease and stroke per se, but to understand on a very personal level what's behind them.

The lesson from here and elsewhere is clear. "Of the decline in heart attacks, about half is due to a management of risk factors and half is due to improved medical care," Coresh says.

People stopped smoking. They started taking drugs to control blood pressure and cholesterol. Surgeons reopened arteries, and hospitals built cardiac care units. So why is the trend in improving heart health leveling out? That's partly because the easier steps have been taken. But there's another big reason.

"The greater cause of the stagnation in cardiovascular death rates is that the obesity epidemic, which started in this country in about 1985, is finally coming home to roost," says Donald Lloyd-Jones, a physician and chair of the department of preventive medicine at Northwestern University.

Obesity raises blood pressure, cholesterol levels and the risk of diabetes.

"All the things that put us at risk for heart disease and stroke get much, much worse," he says.

And considering the burden of obesity in this country now, by 2030 heart disease could cost a whopping $800 billion a year, Lloyd-Jones says. That's equivalent to the stimulus package that Congress passed in 2008 to prevent a global financial disaster.

"That was a hard lift for our political system," Lloyd-Jones says. "By 2030 the American Heart Association is projecting that we'll have to pass that bill every single year just to pay for cardiovascular diseases."

This is not just a potential financial disaster. It could also be a blow to the expectation that our collective health will just keep getting better.

That idea was first challenged when the former Soviet Union collapsed, according to David Jones, a medical historian and physician at Harvard University. When that happened, life expectancy there fell by five years. AIDS in sub-Saharan Africa led to an even worse decline.

"Those two warning signs really burst the bubble that people had had about this expectation of inevitable progress," Jones says. "And people realized that the great gains we had made over the 20th century were potentially vulnerable if certain things went wrong."

Obesity is a slow-moving epidemic, so it may not result in a rapid rise in deaths. And even with the burden of obesity, Jones says, it still might be possible to reduce heart disease rates further, by eliminating smoking and controlling blood pressure and cholesterol.

So would that be purely good news? That depends.

"The question of what we would die of in the absence of heart disease is one of those million-dollar questions, and one of these things that people have been puzzling about for a long time," Jones told Shots.

That question is starting to come into focus at the medical building in Washington County. As the study group has grown older, the research has evolved to address their ongoing health challenges and to look at the risks that now loom for this generation.

For example, hearing tests have been added to the list, as part of an effort to understand the next potential epidemic in this country: dementia.

Memory loss can be hastened by failing hearing. It can be caused by degenerating neurons, as is the case in Alzheimer's, and it can also be triggered by what causes heart disease: clogged and hardened arteries.

Coresh says some dementia is probably amenable to prevention if research projects like his can pin down the risk factors, "but it's going to need decades of prevention, so we probably need to have risk factors treated in middle age if we're going to prevent disease in older age."

If medical science can indeed hold the line on heart disease, it would be disheartening if that simply meant people died of dementia instead.

You can reach Richard Harris by email.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Breaking Taboo, Swedish Scientist Seeks To Edit DNA Of Healthy Human Embryos

NPR Health Blog - Thu, 09/22/2016 - 5:07am
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September 22, 20165:07 AM ET Heard on Morning Edition Alicia Watkins for NPR

A scientist in Sweden has started trying to edit the DNA in healthy human embryos, NPR has learned.

The step by the developmental biologist Fredrik Lanner makes him the first researcher known to attempt to modify the genes of healthy human embryos. That has long been considered taboo because of safety and ethical concerns.

Lanner is attempting to edit genes in human embryos to learn more about how the genes regulate early embryonic development. He hopes the work could lead to new ways to treat infertility and prevent miscarriages. He also hopes to help scientists learn more about embryonic stem cells so they can someday use them to treat many diseases.

The fear is that Lanner's work could open the door to others attempting to use genetically modified embryos to make babies.

Making changes to the DNA in human embryos could accidentally introduce an error into the human gene pool, inadvertently creating a new disease that would be passed down for generations, critics say.

Some also worry the experiments could open the door to so-called designer babies that would let parents pick and choose the traits of their children.

Lanner, however, says he is initially planning only to study the modified embryos for the first seven days of their growth and would never let them develop past 14 days. The potential benefits could be enormous, he argues.

"Having children is one of the major drives for a lot of people," Lanner says. "For people who do struggle with this, it can tend to become an extremely important part of your life."

Lanner also hopes to learn things that could help scientists who are trying to turn stem cells from human embryos into new treatments for diseases.

"If we can understand how these early cells are regulated in the actual embryo, this knowledge will help us in the future to treat patients with diabetes, or Parkinson, or different types of blindness and other diseases," he says. "That's another exciting area of research."

Fredrik Lanner (right) of the Karolinska Institute in Stockholm and his student Alvaro Plaza Reyes examine a magnified image of an human embryo that they used to attempt to create genetically modified healthy human embryos.

Rob Stein/NPR

NPR recently got exclusive access to Lanner's labs at the Karolinska Institute in Stockholm to watch some of his early efforts.

During the visit, Lanner and a graduate student carefully thawed five embryos donated by couples who had gone through in vitro fertilization at the Karolinska University Hospital to try to have children.

One of the embryos didn't survive the freezing and thawing process. The researchers gingerly placed each of the remaining 2-day-old embryos into a dish on a special microscope.

"You need to be stable on your fingers and hands while doing this," Lanner said, quipping, "You don't want to be dropping the embryos while taking them out."

Shots - Health News In Hopes Of Fixing Faulty Genes, One Scientist Starts With The Basics

With Lanner looking on, the student injected one of each embryo's four cells with a genetic engineering tool known as CRISPR-Cas9 while holding the embryo in place with a thin glass rod.

The gene-editing tool comprises two molecules that can zero in on individual genes and make very precise changes to the DNA. It lets scientists modify DNA much more easily and precisely than ever before. Lanner calls the technique a "game changer."

"It's not just quicker or cheaper," Lanner says. "This actually opens the door to start to look at this for the first time, because we could not do this at all previously in the human embryo. The technology was just not efficient enough to try to look at individual gene function as the embryo develops."

Lanner is planning to methodically knock out a series of genes that he has identified through previous work as being crucial to normal embryonic development. He hopes that will help him learn more about what the genes do and which ones cause infertility.

He declined to specify which genes he's targeting until the work is reviewed and published.

During the visit by NPR, one of the embryos got severely damaged when the injection needle got clogged. But the researchers successfully injected the remaining three embryos and placed them in an incubator to continue developing. One embryo divided again immediately after being injected, showing that it could still grow.

Two of the embryos survived in good enough shape to be analyzed later, Lanner explained in an email afterward.

Lanner has now done this on at least a dozen embryos, but is still studying his results and refining his techniques. He remains unsure how well the editing is working so far. However, he's confident he'll be able to modify individual genes in the embryos to determine their function.

"It will be very exciting. We're fortunate to be in this position," Lanner says. "This is a privilege to be in this position."

Shots - Health News Scientists Debate How Far To Go In Editing Human Genes

But just the act of attempting to edit the DNA in healthy human embryos is extremely controversial. Chinese scientists triggered an international uproar earlier last year when they tried to edit the DNA of human embryos even though they used only defective embryos that had no hope of developing.

Experiments like these intensified calls for a moratorium on such research, and the National Academies of Sciences, Engineering and Medicine launched the Human Gene-Editing Initiative to sort through the complex scientific and ethical issues they raise.

Organizers of an international summit convened in Washington, D.C., last year as part of that process concluded that it was far too early to try to create a baby from embryos that had their genes edited.

But the organizers said basic research like Lanner's could be acceptable. A final report from the gene-editing initiative is expected late this year or early next.

Still, not everyone agreed with the summit organizers' assessment. Some people have moral objections to doing any research on human embryos because they consider a human embryo to have the moral standing of a person.

And editing the DNA in embryos is controversial even among people who think human embryonic research is acceptable. That's the position of Marcy Darnovsky, who heads the Center for Genetics & Society, a watchdog group based in California that supports human embryonic research.

"The production of genetically modified human embryos is actually quite dangerous," Darnovsky says. "It's a step toward attempts to produce genetically modified human beings. This would be reason for grave concern."

One fear is that scientists could make some kind of mistake, accidentally creating new diseases that would be passed down for generations.

"When you're editing the genes of human embryos, that means you're changing the genes of every cell in the bodies of every offspring, every future generation of that human being," Darnovsky says. "So these are permanent and probably irreversible changes that we just don't know what they would mean."

But even if it's safe, Darnovsky and others still worry about what designer babies would do to society.

"If we're going to be producing genetically modified babies, we are all too likely to find ourselves in a world where those babies are perceived to be biologically superior. And then we're in a world of genetic haves and have-nots," Darnovsky says. "That could lead to all sorts of social disasters. It's not a world I want to live in."

Lanner says he has no interest in ever doing anything like that. In fact, at the moment it would be illegal in Sweden. And, Lanner says, much more research would be needed to make sure it would be safe before anyone tries to use a genetically modified embryo to make a baby to prevent diseases.

"It's not a technology that should be taken lightly," he says. "So I really, of course, stand against any sort of thoughts that one should use this to design designer babies or enhance for aesthetic purposes."

But Lanner argues that basic research is necessary and morally acceptable, and banning it would be counterproductive.

"I think it's wise to be allowed to do fundamental research so we can gain more information about this technology and potentially use it in the future," he says.

Lanner plans to continue attempting to edit the DNA in healthy human embryos until he develops efficient editing techniques that will allow him to study the genes involved in early embryonic development. Scientists in Britain are planning to start similar experiments later this year.

Research using human embryos is legal in the U.S., but not with the support of federal funds. U.S. labs that are known to be active in human embryo research have not announced any plans to proceed with gene-editing experiments.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

How A 'Sixth Sense' Helps Simone Biles Fly, And The Rest Of Us Walk

NPR Health Blog - Wed, 09/21/2016 - 5:01pm
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September 21, 20165:01 PM ET Heard on All Things Considered

Simone Biles flies through the air while performing on the balance beam at the Olympics in Rio de Janeiro.

Dmitri Lovetsky/AP

A rare genetic disorder is helping scientists understand our mysterious ability to sense where we are in space, known as proprioception.

This "sixth sense" is what dancers and gymnasts rely on to tell them the exact position of their body and limbs at every moment. It also tells them how much force each muscle is exerting.

"The most beautiful demonstration of proprioception in action is Simone Biles when she is spinning and somersaulting through the air," says Carsten Bonnemann, a pediatrician and geneticist at the National institute of Neurological Disorders and Stroke.

Scientists have known about proprioception for more than a century. But they didn't realize how much people depend on it until they got a chance to study two young patients with a rare genetic disorder that leaves them completely lacking this sense.

The results of that study were published Wednesday in the New England Journal of Medicine.

One of the participants in the study was a 10-year-old girl named Damiana, who lives in San Diego.

She's "a happy and bubbly" kid who has no problems with senses like taste, hearing, sight and smell, Bonnemann says. But Damiana was born with a genetic mutation that left her with a limited sense of touch and no proprioception, he says.

When Damiana was younger, her condition baffled doctors, says her mother, Diana Sawyer.

"She was very late at doing everything," Sawyer says. Her daughter didn't start crawling until she was about 18 months old. And she still can walk only a few steps on her own.

Damiana was born with some abnormalities in her feet and hips, Sawyer says. And her spine was curved. But those problems didn't explain why her daughter had so much trouble with precise movements, like fastening a button.

Damiana's condition might have remained a mystery if Bonnemann hadn't seen her a few years ago while holding a clinic in San Diego.

He was puzzled by her symptoms and ordered a state-of-the-art genetic analysis. It turned up a mutation in a gene called PIEZO2, which allows certain cells to detect mechanical pressure.

Unfortunately, "I didn't know what PIEZO2 was, really," Bonnemann says.

Then one day Bonnemann heard about a colleague at the National Institutes of Health who knew a lot about PIEZO2. "It turns out he's in the same building, just a floor down," Bonnemann says. "So I sent him an email saying, 'Can you help me?' "

The colleague was Alex Chesler from the National Center for Complementary and Integrative Health. Chesler read the email from Bonnemann, "and 30 seconds later I was up in his office," he says.

Chesler had spent years studying PIEZO2 in mice. But he'd never had a good way to study its function in people.

So last year, Bonnemann, Chesler and a team of researchers invited Damiana and another patient with a similar PIEZO2 mutation to the NIH.

The visit was a revelation. Trying to understand proprioception from mouse experiments had been a bit like trying to understand Beethoven by reading sheet music, Chesler says. "But when I talked to the patients it was like going to the symphony," he says.

The researchers were able to show that the PIEZO2 gene is involved in certain kinds of touch sensation as well as proprioception. And they learned a lot about what proprioception makes possible by studying what the patients were unable to do.

"They've never run, they've never jumped," Chesler says, "because those kind of actions really require precise control over your limbs in space."

The scientists also discovered that both patients had found ways to compensate for their lack of body awareness — mostly by closely watching their own limbs as they move.

For example, the older patient, who is in college, has even learned to walk pretty well — as long as she can see what's she's doing.

"If you take away her vision, she literally crumples to the ground," he says. "And the same is true for reaching. When she reaches for an object under visual control she is actually quite precise doing that. If we cover her eyes, she gets completely off target."

Of course, gymnasts like Simone Biles also rely on vision during a routine, Bonnemann says. But it's the extra information from their "sixth sense" that makes a gold-medal performance possible.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Mylan CEO Claims EpiPens Aren't As Profitable As Everyone Thinks

NPR Health Blog - Wed, 09/21/2016 - 12:31pm
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September 21, 201612:31 PM ET Heard on All Things Considered

Heather Bresch, CEO of Mylan Pharmacueticals, will face lawmakers' questions Wednesday about the company's steep price hikes for the company's life-saving EpiPen auto-injector.

Dale Sparks/AP

The drug company that makes the EpiPen says it isn't nearly as profitable as many people assume it is.

At least that's the message Mylan NV CEO Heather Bresch will try to deliver to members of Congress today.

Bresch, who is scheduled to testify before the House Oversight and Government Reform Committee, is expected to tell lawmakers that the company earns $100 profit on each two-pack of EpiPen auto-injectors, even though they carry a $600 price tag.

"The misconception about our profits is understandable, and at least partly due to the complex environment in which pharmaceutical prices are determined," Bresch says in prepared testimony. "The pricing of a pharmaceutical product is opaque and frustrating, especially for patients."

Bresch says it costs the company about $69 to make two EpiPens, and after rebates and fees, Mylan receives $274 per EpiPen pack. She says other, unnamed costs absorb an additional $105, leaving $100 in profit for the company.

Shots - Health News EpiPen's Dominance Driven By Competitors' Stumbles And Tragic Deaths

While the company apparently is looking to use the analysis to downplay its profits, analysts say the margin is still quite high.

Ronny Gal, a pharmaceutical industry analyst at the investment firm Sanford Bernstein, says Bresch's numbers mean Mylan makes a 40 percent profit margin on the device.

The EpiPen is a long, plastic tube that automatically injects a dose of epinephrine — or adrenaline — into a person's thigh to stop an allergic reaction. It's easy to use and portable.

Mylan bought rights to the EpiPen in 2008 and launched an aggressive marketing and awareness campaign. That effort has made the so-called auto-injector a must-have for anyone with a serious allergy — perhaps to bee stings or tree nuts — that may trigger anaphylaxis, a life-threatening reaction in which the airways swell and close.

The company has come under fire in recent months, however, because it raised the price of the device, which has been available for decades, more than 500 percent.

The wholesale price of a single pen was about $47 in 2007, and it rose to $284 this summer, according to Richard Evans, a health care analyst at SSR. But consumers can no longer buy a single pen, so the retail price to fill a prescription today at Walgreens is about $634, according to GoodRX.

Mylan has tried to quell the criticism first by offering customers a coupon worth up to $300 to offset the price of the device, and then announcing it would bring a generic version of the EpiPen to market for half the retail price.

In addition to the investigation by the House Oversight committee, at least three senators have also called for investigations into Mylan's pricing practices. Sens. Charles Grassley, R-Iowa, and Richard Blumenthal, D-Conn., have sent letters to Mylan demanding an explanation for the increase.

Mylan responded with a letter that Grassley, in a press release, said was "incomplete."

Sen. Amy Klobuchar, D-Minn., has asked the Federal Trade Commission to investigate whether Mylan has violated antitrust laws in its marketing of the EpiPen.

And the Senate Finance Committee is reviewing the rebates that Mylan offered to the Center for Medicare and Medicaid Services.

In her testimony, Bresch says the company did not intend for its price hikes to hurt patients.

"Looking back, I wish we had better anticipated the magnitude and acceleration of the rising financial issues for a growing minority of patients who may have ended up paying the full [Wholesale Acquisition Cost] price or more," she says. "We never intended this."

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Flabby And Fertile: How Men Age Could Be Huge For Humans

NPR Health Blog - Wed, 09/21/2016 - 9:28am

Big muscles help young men find mates. But as men get older, losing muscle mass and testosterone might actually aid in reproduction.

Westend61/Getty Images

Most animals die once they can no longer have kids, but men and women tend to totally buck this trend, living decades beyond their reproductive years despite drastic changes in their bodies.

A book out in September, How Men Age: What Evolution Reveals About Male Health And Mortality, explores the toll that children take on their parents' bodies, how love handles and paunches can turn "evolutionary lemons into lemonade," and how men may be responsible for humans' relatively long lives.

Here's our conversation with author Richard Gutierrez Bribiescas, a biological anthropologist at Yale University, edited for length and clarity.

Let's start with a simple question. Why does hair go gray?

The cells that actually give your hair color are constantly bombarded by free radicals. And eventually the cells that make the pigment melanin, which colors your hair, go away and your hair turns the neutral color that you would see without these pigments. You see it in other animals, too. Dogs start getting a white muzzle.

On to bigger things. What are some weird things about humans when it comes to aging? Is human aging unique?

Human aging is primarily unique because it's not correlated with the end of reproduction. If you're a female, about a third of your life span is postmenopausal. That's huge and very, very strange.

We also provide care to the elderly. Older individuals who probably would not be able to survive on their own are able to survive well into their 70s and 80s with the help of relatives and friends. That's another thing that's very unique about humans.

Why do we age in the first place? Why don't we just live forever?

Aging and the evolution of sexual reproduction seem to go hand and in hand. An organism that has to reproduce requires energy and resources that would otherwise go to keeping it alive, like repairing or replacing damaged cells.

That reminds me of your quote that "natural selection does not care about your health or if you feel good." What does natural selection care about, if we're going to personify it?

Natural selection favors traits that allow us to reproduce more efficiently. This is the reason why we end up with organisms like mice, which live a couple of years if they're lucky, compared with elephants that can live 70 years.

Longevity is just one trait that will be selected for, but only if it serves to improve reproduction. And if it makes us feel good along the way, that's great. But that's not the goal of natural selection.

Reproduction comes with a huge cost. What's the toll that children can take on females?

It's known pretty well that the more females invest in reproduction, the more their lifespans are compromised. One of my colleagues in Poland, Grazyna Jasienska, did a demographic study on rural women and, looking at church records, showed that their lifespans were shortened by about 18 months for every child that they had. There's a pretty significant inverse relationship between number of children and lifespan, and this has been shown in different populations and other organisms.

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What Evolution Reveals about Male Health and Mortality

by Richard G. Bribiescas

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Why?

My lab's hypothesis has to do with oxidative stress. Every time you take a breath, you support oxidative metabolism, but you also generate toxins in the form of free radicals that cause you to age faster. They cause cellular damage and genetic damage, and it's the reason why you've heard about antioxidants. That's why you eat salmon and blueberries and things like that.

We hypothesized that the more children females have, the more bouts of oxidative stress they have — because every time a woman undergoes a pregnancy, the amount of oxygen that she uses goes up dramatically to support the fetus. So, we looked at biomarkers of oxidative stress in the women in rural Poland. And sure enough, the ones who had more children had higher levels for these biomarkers of oxidative stress.

How about for males?

The reproductive costs of males are a little bit different.

What's interesting is that a lot of the costs are associated with behavioral risks. For example, we know that between the ages of about 15 and 25, in pretty much every population including in nonhuman primates, there's a big increase in male mortality, and usually it's due to risky behavior. You end up seeing males do stupid things to procure mates. That's why it's very expensive to insure an 18-year-old if he has a car.

Risky behavior is one cost. The other cost is energetic.

Like big muscles?

Yeah, absolutely. Skeletal muscle is expensive. A calorie that is burned by skeletal muscle is one calorie that can't be used to repair a damaged kidney cell. So, having big muscles may be great for your social life, but it's not very useful if you have an infection.

Later in life, those muscles go away. If I'm a middle-aged man with love handles and a paunch, are those signs that I've failed?

I call it turning evolutionary lemons into lemonade, because as men get older, it's harder to keep muscle on, their testosterone goes down, and they may develop a little paunch. But it turns out that those traits — say, a little extra fat and lower testosterone — may actually help them reproduce later in life.

It was assumed that when females underwent menopause and stopped reproducing that men did the same. But there was a paper that came out a few years ago by this brilliant biologist at Stanford named Shripad Tuljapurkar. He showed that when you looked at non-Western populations, men sometimes have kids well into their 80s.

It struck me, because it suggested that perhaps the evolution of menopause or longevity might not totally lie with females, but actually with males. If males are reproducing at older ages, they're passing on those longevity genes not only to their sons but also to their daughters.

So, is it a failure or success? I think the ability to actually leverage this paunch in a way that makes you still able to produce children and to increase your fitness — I think you could put that in the win box.

One of your colleagues summarized your early research as "macho makes you sick." Why do men have shorter life spans than women?

Well, it just seems that the physiology of males make them more frail as they get older. And it seems to be universal.

Males and females tend to die of the same things once they get past older ages, like cancer and cardiovascular disease. But it turns out that males simply don't recover as well as females do.

For example, with infections, testosterone suppresses immune function. It's kind of ironic that the hormones and things that make men physically stronger are the same things that actually make males the more frail sex.

Males are the more frail sex. Is that a controversial statement?

No, I think people confuse strength and virility. The cost associated with the way males reproduce results in shorter life spans.

I think a lot of people assume that research going on in North America or Europe is true for all humans, but you say that's not necessarily so. What are some assumptions about aging that non-Western populations have overturned?

You turn on the radio and you hear these commercials for testosterone supplements. It's assumed that as you get older, your testosterone is going to decline and somehow that's bad and you have to fix that. But there's a lot of fuzziness around that assumption. For example, within the United States there's a huge range of variation in testosterone levels at younger and at older ages. They vary by tenfold and we don't know why.

So, what could be "low" or "high" really depends on the individual, and age only accounts for about 15 percent of the variation.

There is sort of a very faint signal to show that testosterone does decline with age in Western males. But it's not universal. If you look at hunter-gatherer groups, their testosterone levels don't change very much throughout their lifetimes. They start out with lower levels as adults and they pretty much maintain that their entire lives. So, the assumption that testosterone is going to change as you age is not necessarily true everywhere.

The other study we did was in Japan, where we looked at testosterone levels. And what we found was really interesting. These were urbanized men living in a suburb of Tokyo. And just like men in the U.S., their testosterone levels were highest when they were in their mid-20s and then they started to drop off. But after about age 40, their testosterone levels stayed constant.

We're trying to figure out why there's this difference compared with what you see in the United States.

So it's very interesting to understand where culture and biology are going to affect each other. And it's going to be reflected in things we may assume to be universal in terms of health. But we have to be cautious about that, because sometimes that's not the case.

Read an excerpt of How Men Age

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Doctors Who Treat Opioid Addiction Often See Very Few Patients

NPR Health Blog - Tue, 09/20/2016 - 12:01pm

Health care providers have to have permission from the federal government to provide medication-assisted treatment for opioid addiction.

The Washington Post/Getty Images

Many people struggling with opioid addiction can't find a doctor to provide medication-assisted treatment, even though it's highly effective. One reason could be that doctors who are qualified to prescribe the medication typically treat just a handful of patients.

Researchers at the RAND Corporation looked at pharmacy records from the seven states with the most doctors approved to prescribe buprenorphine, which helps people manage cravings and avoid withdrawal. They found 3,234 doctors who had prescribed the drug, also known as Suboxone, to new patients from 2010 to 2013. The median number of patients by a doctor treated each month was 13. About half of the doctors treated 4 to 30 patients; 22 percent treated less than 4; 20 percent treated 31 to 75.

"We were really surprised," says Dr. Bradley Stein, a psychiatrist and lead author of the study, which was published Tuesday in JAMA, the journal of the American Medical Association. "We found that only about 10 percent of doctors were what we would call heavy prescribers, with more than 75 patients a month."

Shots - Health News Treating Opioid Addiction With A Drug Raises Hope And Controversy

Only a fraction of the 4 million people thought to abuse prescription painkillers or heroin in the U.S. are getting medication-assisted treatment.

There's been a big push to make it easier for doctors to prescribe buprenorphine, including new rules announced by the Obama administration in July that raised the number of patients a doctor can treat from 100 to 275. But this data suggests that those limits aren't the only barrier to getting treatment to more people.

The researchers also were surprised to find that most patients weren't prescribed buprenorphine for very long, even though it can be used long term. The mean length of prescribing was 53 days per patient.

"This really brought home for us the need for multiple approaches, so doctors are willing and able to prescribe buprenorphine," Stein says.

Urban areas have typically been better equipped to provide treatment for opioid addiction, whether with methadone clinics or with buprenorphine, which people can take at home and doesn't require people a daily clinic visit. But many people struggling with opioid addiction live in smaller cities or rural areas where physicians have little experience with treating addiction to heroin and prescription opioids.

Shots - Health News A Small Town Bands Together To Provide Opioid Addiction Treatment

That includes towns like Bridgton, Maine, where family physicians shied away from treating addicts until they realized that their own patients were the ones overdosing and dying.

Just taking an online course on how to prescribe buprenorphine won't be enough for many providers, Stein says, especially since many patients with opioid addiction also have other problems that need care. "We really need to think about providing mentorship, providing consultation, providing clinical support," Stein says.

Medication-assisted treatment is supposed to include counseling, and that can be hard to find, especially in rural areas. "So we may need to think about telehealth or online counseling," Stein says. "We may need to be creative to have people receive effective treatment, no matter where they live."

Treatment can work, "People can recover. They go on to live incredibly productive lives. And we want to have the high-quality treatment to get them there."

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Weight Loss On Your Wrist? Fitness Trackers May Not Help

NPR Health Blog - Tue, 09/20/2016 - 11:19am

They're so cute. So colorful. But are they really making you fitter?

Paul Marotta/Getty Images for Fitbit

Fitness trackers remain wildly popular, but do they make us fit? Maybe not, according to a study that asked overweight or obese young adults to use the tiny tracking tools to lose weight.

The 470 people in the study were put on a low-calorie diet and asked to exercise more. They all started losing weight. Six months in, half the group members started self-reporting their diet and exercise. The other half were given fitness trackers to monitor their activity.

After two years, both groups were equally active. But the people with the fitness trackers lost less weight.

Wait. What? We asked John Jakicic, a researcher of health and physical activity at the University of Pittsburgh and the lead author on the study, why this could be.

"These technologies are focused on physical activity, like taking steps and getting your heart rate up," says Jakicic. "People would say, 'Oh, I exercised a lot today, now I can eat more.' And they might eat more than they otherwise would have."

It's also possible, he says, that meeting daily fitness goals and step counts might motivate one person, but missing those same goals could discourage another.

The device in the study, which was published Tuesday in JAMA, the journal of the American Medical Association, wasn't a wrist-tracker like the Fitbits, Jawbones, Apple watches and Nike bands many use now. This device was worn around the upper arm. Instead of using heart rate to estimate activity like some devices do, it measured the heat generated by exercise.

Still, he says, the results from this study are relevant to the devices of today.

Overall the participants without fitness trackers lost 13 pounds, while the tech-enhanced group lost 7.7 pounds. They ranged in age from 18 to 35 years and had BMIs from 25 to 39. The study hopes to see whether helping young adults lose weight early on can head off more weight gain in middle age.

We reached out to Fitbit to see what it thought of the study.

"We are confident in the positive results users have seen from the Fitbit platform, including our wearable devices," the company said in a statement, adding that researchers use Fitbits and similar devices in clinical studies.

While those studies use wearable technology to investigate everything from heart disease to breast cancer, very few have looked at how good these trackers actually are at helping people achieve fitness goals.

"There aren't many — if any — long-term studies of wearable tech," says Dr. Mitesh Patel, an assistant professor of medicine at the University of Pennsylvania. Patel also studies fitness trackers but was not involved in this study. This study, Patel says, is the longest yet, "and that's why this research is important. We need more studies like this to show what wearable tech can and can't do."

A handful of short-term studies have looked at fitness trackers, with mixed results. One study, also conducted by Jakicic, found that fitness trackers could replace counseling in a weight-loss program. But another found that users get bored and abandon their wristbands after just a few months.

Ultimately, Patel says, these devices are most effective when the people using them are already dedicated to tracking their fitness. People who are less motivated might not get the same results.

"Overall, it doesn't look like assigning someone wearable technology will make that big of a difference," says Jakicic.

So should you bin your Fitbit? Not yet. Jakicic thinks that combining this technology with behavioral research can help scientists figure out which groups of people benefit from fitness trackers and even design interfaces that will be more motivational.

"These devices have some really cool tech, but how do you use them in a way that helps people?" asks Jakicic. "That's a science in and of itself."

Copyright 2016 NPR. To see more, visit NPR.
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Tax Rule Limits Care For Chronic Ills Under High-Deductible Health Plans

NPR Health Blog - Tue, 09/20/2016 - 10:49am

Under Internal Revenue Service rules, high-deductible insurance plans that can link to health savings accounts can only cover preventive services, such as vaccinations and mammograms, until patients pay down their deductible.

Andrew Caballero-Reynolds/AFP/Getty Images

As the number of people covered by high-deductible health plans soars, some insurers and employers are easing the strain on consumers' wallets by covering certain benefits like doctor visits or generic drugs before people have reached their plan's deductible.

But there's a hitch: Under Internal Revenue Service rules, high-deductible plans that can link to health savings accounts can only cover preventive services, such as vaccinations and mammograms, until patients buy enough services on their own to pay down their deductible.

A bipartisan bill was introduced in Congress in July that would allow high-deductible plans that can link to health savings accounts to cover care for chronic conditions like diabetes and heart disease before plan members have met their deductibles.

HSAs were introduced in 2004, reflecting the popular belief that if consumers had more financial skin in the game they would make smarter, more cost-effective decisions. Individuals and their employers can deposit money into the accounts tax free, where it grows tax-free and can be withdrawn tax-free to use for medical expenses.

The accounts must be linked to health plans that meet certain federal standards, including minimum deductibles of $1,300 for individuals and $2,600 for families in 2016. The plans are required to cover preventive services without cost sharing, but consumers must pay for all other services until they meet their deductible.

Many high-deductible plans don't meet those standards. The deductible coverage restrictions for HSA plans can be a sticking point when employers and insurers consider which plans to offer.

"I've worked with numerous clients that chose not to pursue an HSA strategy because they wanted their employees to be able to get coverage not subject to the deductible," said Jay Savan, a partner at Mercer Health and Benefits, a consulting firm.

This legislation would lift those restrictions to some degree, but its passage is far from assured.

The law could make a big difference to Cheri Amos-Prater. Diagnosed with rheumatoid arthritis and psoriasis 10 years ago, the 54-year-old drug sales representative had been paying approximately $50 in monthly copayments to her health plan for Humira, a drug sold by AbbVie, the company she works for. This year, she switched to a high-deductible plan with a health savings account, not realizing that she would be responsible for paying the first $3,000 of her medical care to satisfy her deductible before her plan's coverage kicked in. Her Humira alone would have cost $2,100 in January. Unable to afford it, she stopped taking the drug.

"I didn't realize that in the fine print of the policy it said that if I made this choice I couldn't get the drug at a discount" until meeting the deductible, said Amos-Prater, of Birmingham, Ala. She plans to go back to a regular preferred provider organization plan next year.

The legislation has been endorsed by consumer groups and policymakers who are proponents of "value-based insurance design," which encourages health-plan features that nudge consumers to get clinically effective care by reducing or eliminating out-of-pocket costs for such services.

"We need to spend money differently," said Dr. A. Mark Fendrick, director of the University of Michigan Center for Value-Based Insurance Design. "We should put a very high deductible on those things we don't need and incentivize consumers to get the care they need."

For example, he said people with diabetes need to have annual eye exams to prevent adult-onset blindness, "yet the fastest growing type of health plan, HSA high-deductible plans, covers those exams not at all."

Twenty-nine percent of workers with employer-sponsored coverage are enrolled in a high-deductible plan with a savings account of some sort, according to the Kaiser Family Foundation's annual survey of employer-sponsored benefits, up from 17 percent in 2011. (KHN is an editorially independent program of the foundation.)

These enrollees also generally pay more out of pocket for care than do people in traditional plans. People in high-deductible plans were responsible for 24 percent of their medical costs between 2010 and 2014, on average, compared with 14 percent for people in traditional plans, according to a recent study by the Health Care Cost Institute that examined claims data from three major insurers for 40 million Americans. Annual per capita spending out of pocket was $1,030 on average for those in high-deductible plans compared with $687 for people in traditional plans.

Both employer-sponsored and marketplace plans often cover services before the deductible in plans. Two-thirds of plans on the federal marketplace exclude primary care visits from the deductible, according to Avalere Health. Similarly, the deductible doesn't apply to a majority of workers in employer-sponsored plans when they visit their primary care doctor.

Insurers that want to attract people, especially healthy people, realize that offering a plan with hardly any coverage before a huge deductible may not do the trick, said Caroline Pearson, senior vice president at Avalere Health, a research and consulting firm.

Still, it's unclear that insurers would jump at the chance to offer plans that are particularly attractive to people with chronic illnesses, said Linda Blumberg, a senior fellow at the Urban Institute's Health Policy Institute.

America's Health Insurance Plans, a trade group, has endorsed the proposed legislation, because it would give insurers more flexibility to design plans that ensure that consumers get the right treatment at the right time, said AHIP spokesperson Clare Krusing.

Even if there is the political muscle to pass the bill, it could be difficult to design plans that provide pre-deductible coverage for chronic conditions without pushing premiums up, said Pearson.

Advocates of value-based design "would say that if you're covering the right services, it shouldn't increase costs," she said. But how do you discourage coverage of the ineffective physician visits while encouraging coverage of the effective ones? "We are not yet particularly skilled about designing services that are nuanced," Pearson said.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter: @mandrews110

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
Categories: NPR Blogs

Reporter's Notebook: Pregnant And Caught In Zika Test Limbo

NPR Health Blog - Tue, 09/20/2016 - 8:40am
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September 20, 20168:40 AM ET Heard on Morning Edition

From

A Florida Department of Health employee processes a urine sample to test for the Zika virus on Sept. 14 in Miami Beach.

Lynne Sladky/AP

I'm the health reporter covering the Zika story here at WLRN in Miami, and I'm a pregnant woman.

When Florida Gov. Rick Scott made free Zika testing available to all pregnant Floridians through the Florida Department of Health, I was one of the more than 2,200 women who took him up on the offer.

My station's main studios are five blocks south of the Wynwood Zika zone, an area that authorities are recommending pregnant women avoid (though the advisory was updated to a less dire warning on Monday). As it turned out, I had been inside the suspected transmission zone before we knew the risks.

So on the morning of Aug. 12, I went to my obstetrician's office, gave blood and urine samples and was told that it would take about seven to 10 business days to get my results.

Four and a half weeks later, I was still waiting. I had plenty of company.

My colleague Kate Stein has been helping me cover the story, whenever it veers into an area where the Centers for Disease Control and Prevention has advised pregnant women to avoid. Stein covered a Miami Beach town hall I didn't attend. There, she met Joseph Magazine, who pleaded with officials to help his wife get her Zika test results back. She was more than five months pregnant, had experienced Zika-like symptoms a month earlier, and was waiting to hear if she had been infected.

Press releases and other communications from the Florida health department officials have repeatedly insisted it takes one to two weeks to get results.

But at another town hall, after some pushing, Dr. Lillian Rivera, head of the Miami-Dade County Department of Health, said women may wait longer. "It could be four weeks, it could be five weeks," Rivera said. "We are preparing them for that."

Rivera was quick to point out that complete testing can take a long time, depending on the first round of results. That's because the Zika test for a pregnant woman can actually be a couple of different tests. The first test is to see if she has an active infection. If that's negative, there's a test to see if she has had the virus in the past 12 weeks. If that's negative, case closed.

Sammy Mack got tested for the Zika virus after realizing she had been in the suspected transmission zone in Miami while pregnant.

Courtesy of Sammy Mack

But if the second test is positive, or inconclusive somehow, then the woman's samples are sent to the CDC for an even more specialized test to confirm it's Zika and not dengue or another virus that can cause false positives.

As of last week, Florida had sent 174 tests to the CDC for clarification, including the tests of people who aren't pregnant. That total doesn't explain the backlog in which I was snarled.

Obstetrician Christine Curry, with the University of Miami and Jackson Health System, says it's helpful that all pregnant women in Florida can be tested. But getting timely test results is important, too.

"If someone's early first trimester or second trimester and we delay disclosure because we don't have a result by two weeks, four weeks, six weeks, eight weeks — that may be long enough for them to be out of the window of being able to terminate that pregnancy," she said.

Florida law restricts abortion access after 24 weeks. Later-term abortions are also more complicated procedures and more emotionally fraught for parents.

Delays in test results can change the way doctors screen the newborns of women who are still waiting on their Zika test results, Curry says. "Do we do more invasive, more aggressive testing? Do we do blood tests and urine tests and a spinal tap on the child?"

I spoke to Curry after I had been waiting more than a month for my results, and that image jars me: a spinal tap on my newborn because of a bureaucratic backlog on test results?

This is when I start to get nervous and angry.

Zonnia Knight, a fellow pregnant South Floridian, compares the waiting period for the test results to being told there are spiders in the room.

"You find yourself scratching, or looking around, swatting off ghosts and stuff," she says. "To me, there was a mosquito everywhere."

Knight waited three weeks with those ghosts before her Zika results came back. She was negative.

Dr. Christine Curry is an obstetrician who has treated pregnant women infected with Zika. She says the health of women and their babies may be in jeopardy when Zika virus test results are delayed.

Sammy Mack/WLRN

Another pregnant woman, Tracy Towle Humphrey, went to a private lab for her test and bypassed the health department. Without insurance, those tests can range from about $150 to almost $800.

Humphrey's insurance covered it, though. Within one week, she got her negative results back.

But she says for that week, she had trouble sleeping. She would wake up in the middle of the night "thinking, 'Oh my gosh, what if it's positive? What are we going to do?'"

After 4 1/2 weeks, I called the Florida Department of Health.

I didn't identify myself as a reporter. I was afraid that might affect my ability to get information on my own records. I was repeatedly told the health department doesn't give out results over the phone and they'll be sent to my doctor.

But after explaining a couple of times that I just wanted to know where my test was, I ended up talking to someone in the local epidemiology department who said she might be able to look up my test. She did, and I learned my test results were completed in the state lab in Jacksonville on Aug. 19 and Aug. 26.

So my completed tests were sitting there, I learned, for more than two weeks, and neither I nor my doctor had been informed of the results.

"Your story is completely consistent with my understanding," says Dr. David Andrews, who runs the pathology laboratories at Jackson Health System and is on faculty at the University of Miami's med school.

He told me he has had upward of 900 pregnant women waiting on their Zika test results. The backlog is so large, he can't even make a good calculation on the average turnaround time. "It is my sense that most of these specimens have been tested and are being tested in a reasonable amount of time, but the bottleneck appears to be getting us back the reports," Andrews says.

Mara Gambineri, a spokesperson for Florida's health department, sent an email that didn't specifically respond to my question about why it takes so long to release results once the tests are completed:

"The department has been working with area hospitals and providers, particularly in Miami-Dade County, to ensure doctors are receiving test results quickly and communicating the information with their patients. We continue to work to improve and streamline the process."

Another spokesperson named Sarah Revell said in the same exchange of emails:

"The department continues to dedicate significant resources to our public health labs and we have contracted with a private lab to assist with processing Zika tests quickly and accurately. Florida is the first and only state to offer such extensive resources to pregnant women and we are constantly working to improve our process."

On Wednesday, Sept. 14, Gov. Scott announced the CDC is sending seven more people to help out with labs and testing "in order to ensure pregnant women get results back faster."

On Friday, Sept. 16, a few hours after WLRN aired a story about the testing backlog and my wait, I got a call from the county health department asking for my doctor's contact information. They released my test results to my obstetrician, who shared them with me: They are negative.

Kate Stein contributed to this report. This story is part of a reporting partnership with NPR, WLRN and Kaiser Health News.

Copyright 2016 WLRN Public Radio. To see more, visit WLRN Public Radio.
Categories: NPR Blogs

When Blind People Do Algebra, The Brain's Visual Areas Light Up

NPR Health Blog - Mon, 09/19/2016 - 2:08pm
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September 19, 20162:08 PM ET Heard on All Things Considered Stuart Kinlough/Getty Images/Ikon Images

People born without sight appear to solve math problems using visual areas of the brain.

A functional MRI study of 17 people blind since birth found that areas of visual cortex became active when the participants were asked to solve algebra problems, a team from Johns Hopkins reports in the Proceedings of the National Academy of Sciences.

"And as the equations get harder and harder, activity in these areas goes up in a blind person," says Marina Bedny, an author of the study and an assistant professor in the department of psychological and brain sciences at Johns Hopkins University.

In 19 sighted people doing the same problems, visual areas of the brain showed no increase in activity.

"That really suggests that yes, blind individuals appear to be doing math with their visual cortex," Bedny says.

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The findings, published online Friday, challenge the idea that brain tissue intended for one function is limited to tasks that are closely related.

"To see that this structure can be reused for something very different is very surprising," says Melissa Libertus, an assistant professor of psychology at the University of Pittsburgh. "It shows us how plastic our brain is, how flexible it is."

Earlier research found that visual cortex could be rewired to process information from other senses, like hearing and touch. But Bedny wanted to know whether this area of the brain could do something radically different, something that had nothing to do with the senses.

So she picked algebra.

During the experiment, both blind and sighted participants were asked to solve algebra problems. "So they would hear something like: 12 minus 3 equals x, and 4 minus 2 equals x," Bedny says. "And they'd have to say whether x had the same value in those two equations."

In both blind and sighted people, two brain areas associated with number processing became active. But only blind participants had increased activity in areas usually reserved for vision.

The result suggests the brain can rewire visual cortex to do just about anything, Bedny says. And if that's true, she says, it could lead to new treatments for people who've had a stroke or other injury that has damaged one part of the brain.

Drugs or even mental exercises might help a patient "use a different part of your brain to do the same function," Bedny says. "And that would be really exciting."

Copyright 2016 NPR. To see more, visit NPR.
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For Some Seniors Without Housing, A Parking Lot Is Home

NPR Health Blog - Sun, 09/18/2016 - 5:21pm
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September 18, 20165:21 PM ET Heard on All Things Considered

Marge Giaimo stands with her gold Oldsmobile, where she currently sleeps.

Gloria Hillard for NPR

Marge Giaimo makes her way to a picnic table under the shadow of an oak tree. Santa Barbara's trees, like its oceans and mountains, are one thing she says she never tires of here. After losing her senior housing three years ago, this table is where she does her painting these days.

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"I feel very fortunate to have my car," Giaimo says. "It's a little cramped, but it's softer than cement."

Of all her once-valued possessions, today her 20-year-old, gold Oldsmobile is her most important one. It is her home, and she keeps it as neat as a pin.

"And then this is where I sleep," she says. "I have the three pillows and I have sponges under there or foam to sleep on."

In the wealthy coastal city of Santa Barbara, north of Los Angeles, the demand for senior housing is so great the wait list is now closed. After all, California's senior population is expected to grow by 50 percent in the next decade.

For the seniors left out in the cold, their only option is living in their cars.

'It's Hard To Walk Away'

"It is a hidden population and a growing population," says Cassie Roach, who oversees Safe Parking, a city-funded program at the New Beginnings Counseling Center. "And it is quite different from the street homeless."

Safe Parking has designated 115 parking spaces in church, county and city lots where people living in their cars — such as Giaimo — can park safely overnight.

Roach says many of those living in their cars have fallen upon hard times for the first time in their lives.

Among them is 61-year-old Lise MacFarlane. She is grateful for one of those Safe Parking spots.

"I'm more comfortable sleeping now," MacFarlane says.

Around the Nation On LA's Skid Row, Homeless Women Seek Shelter From The Streets

MacFarlane says she lost the home she grew up in last December after being evicted by the new owner.

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"I was sleeping in front of my house and the park," MacFarlane says. "It's hard to walk away. That's it."

She shares her Toyota Highlander with her two dogs and a very large white cat named Willie.

"They don't like being in the car all the time," MacFarlane says. "They want to be in a home."

While most people are having dinner, MacFarlane rolls into her assigned church parking lot.

"It's really hard sitting in the car watching people, watching people I know go by," she says, crying.

Safety And Support

The sun has gone down, but Giaimo's gold Oldsmobile is hard to miss. It's parked a few spaces away from a Honda CRV owned by 74-year-old Barbara Harvey.

"We support one another very much," Harvey says.

"She puts up with me," Giaimo responds.

"There is no putting up with Marge, OK," Harvey says, laughing.

In this women-only lot, friendships are forged. There are seven designated spaces, and later in the evening a lot monitor stops by to check in on them.

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By 7 a.m. they will need to be gone.

The sound of a trash truck heralds the morning in this parking lot. Giaimo and MacFarlane are getting ready to leave for the day.

"It's dog walking time," Giaimo says. "Did I drop something out my trunk?"

"I think you did," MacFarlane responds.

"I can't find my brush. See, this is what we go through," Giaimo says, laughing. "Where did I put my brush?"

MacFarlane loads up her dogs as Willie the cat reluctantly makes room for them on the stacked blankets. Giaimo smiles and waves goodbye.

Giaimo's day continues with a shower at the Y. Then, she'll return to her picnic table.

The 75-year-old painter is on a wait list for senior housing in Santa Barbara. She's been told it could take another seven years.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Cancer Immunotherapy At A Crossroads

NPR Health Blog - Sat, 09/17/2016 - 6:00am

The human body is on alert for malignant cells. Scientists and doctors are getting better at harnessing the human immune system as a weapon against cancer.

Coneyl Jay/Getty Images

It was in 1909 that Nobel Prize-winning German physician Paul Ehrlich proposed the idea that our bodies are fighting constant battles with cancer and that, thankfully, most of the time we win.

Ehrlich was a visionary in recognizing the interaction between cancer and the immune system. Specifically, that cancerous cells are continuously arising in the body but that our immune defenses in many if not most cases keep them at bay.

German physician Paul Ehrlich theorized that our bodies are always fighting off cancer and that usually we win.

U.S. National Library of Medicine

Now, after his and related ideas sputtered along for decades, the theory is at the core of one of oncology's hottest areas, immunotherapy, or the mobilization of the human immune system to fight malignancy.

Few would argue that in just the past few years this field has begun to transform cancer care. Newly approved immunotherapies have increased treatment options and improved patients' odds for a variety of tumors, while also allowing many with cancer to avoid, cut back on or delay chemotherapy. Former President Jimmy Carter's successful treatment for melanoma, including a regimen of immunotherapy along with radiation therapy and surgery, helped push the approach into the public spotlight.

Yet immunotherapy has faced some prominent setbacks. In August a clinical trial of the Bristol-Myers Squibb drug Opdivo, or nivolumab, for a group of patients with newly diagnosed lung cancer, unexpectedly failed as a first-line therapy. The announcement shaved $20 billion off the value of Bristol-Myers in a single day.

Though immunotherapy is generally more tolerable than chemotherapy and radiation, there are side effects to consider. Immunotherapies can cause symptoms like fatigue, nausea and diarrhea; and a recent case report review revealed a possible link between the medications and chronic arthritis.

And then there's the staggering cost, with some immunotherapies running well over $100,000 a year. The immunotherapy drug Yervoy, also from Bristol-Myers, is priced at $157.46 per milligram. "To put that into perspective, that's approximately 4,000 times the cost of gold," Dr. Leonard Saltz, of the Memorial Sloan Kettering Cancer Center, said at last year's American Society of Clinical Oncology Annual Meeting.

Perhaps the biggest question of all about immunotherapies is why don't more people respond to them.

Data presented at this year's American Association for Cancer Research Annual Meeting in April showed that over one-third of patients with malignant melanoma who were treated with Opdivo were still alive after five years, more than double the five-year survival rate for metastatic melanoma patients diagnosed between 2005 and 2011 who were treated with standard cancer therapies of the day.

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Yet as the AACR points out on its blog, "Despite the obvious cause for excitement, this means that about two-thirds of patients with metastatic melanoma who were treated with [Opdivo] had cancer that did not respond to the immunotherapeutic or progressed after initially responding."

And response rates for other tumors tend to be markedly lower: in lung cancer, for example, they hover around 20 percent.

Oncologists and scientists are now faced with determining why some patients respond and others don't, and also how to better predict which treatments are best for which patients. Equally important is understanding how the new treatments should be used with surgery, chemotherapy, and radiation; and whether or not, at least in some cases, immunotherapies can replace these more established options altogether.

Mobilizing the immune system

In 2016, over a century after Ehrlich first proposed his ideas, immunotherapy takes many forms: There are cancer vaccines, antibody therapies, and drugs that drive the immune system to fight off cancer.

But two newer immunotherapy approaches are generating particular buzz.

The first involves engineering a patient's own white blood cells to recognize and attack tumor cells. Called "CAR T-cell therapy," it's still experimental. But it has had some early success for blood cancers like leukemia.

Further along are so-called checkpoint inhibitor therapies. Normally our bodies have what are called immune checkpoints, mechanisms that restrain immune activity so our bodies don't attack our own tissues or get overly aggressive when fighting infection.

The only problem is that cancer can co-opt these off switches by sending out molecular signals that shut down our defenses. Checkpoint inhibitor drugs interrupt the signals cancers use to shield them from the immune system. While earlier immunotherapies broadly activate the immune system, these newer agents specifically boost the activity of a subtype of white blood cell called T-cells, which when activated can zero in on and destroy cancer cells. The improved selectivity reduces collateral damage and side effects.

There are now four checkpoint inhibitors approved for various cancers — including certain lung and kidney cancers, melanoma and most recently bladder cancer — with trials underway in nearly every major tumor type.

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In addition to Opdivo, trial data presented at this year's ASCO annual meeting in June found another checkpoint inhibitor called Keytruda to be effective in advanced melanoma patients. Of the 655 patients in the study, 40 percent were still alive after three years. Other data presented at the meeting suggest that immunotherapies hold promise in a number of difficult-to-treat cancers, including including advanced lung, kidney, bladder and head and neck cancers and Hodgkin lymphoma.

Tailoring cancer care

But where do oncologists go from here? Can patient response rates go from improved to impeccable?

One way is by identifying biological markers that can predict treatment response in a specific person.

Researchers from the University of California, San Francisco recently reported that melanoma patients whose immune cells have higher levels of two checkpoint proteins called PD-1 and CTLA-4 respond significantly better to Keytruda therapy. The group is using the finding to determine which patients are more likely to respond to the treatment.

Similarly, the 15 percent to 20 percent of colorectal cancer patients with what is called an "MSI-high" subtype of tumor respond especially well to immunotherapy.

Another, perhaps more grueling method of improving patient response to immunotherapy is methodically determining how to use and sequence the new drugs with the vast armory of other cancer treatment options — and whether, in some cases, they could replace unpleasant stalwarts like chemo altogether.

"In melanoma this has pretty much already happened in many cases. We're often using these drugs as front-line therapy," says Dr. Elizabeth Buchbinder, an oncologist at the Dana Farber Cancer Institute in Boston. "However in other tumors it's a lot more variable and I think in general these will be something to consider alongside the other treatments."

Buchbinder explains that while melanoma patients treated with a single checkpoint inhibitor see response rates between 30 percent and 40 percent, those rates climb to 60 percent when a second immunotherapy is added.

"I think these will become part of a combination of strategies," concurs Sloan-Kettering oncologist Marcel van den Brink. "Just look at chemo. There are almost no situations where one chemotherapy alone would even come close to curing a cancer of any type. The big breakthroughs here came when we carefully figured out combination therapies."

Improving cancer outcomes will involve personalizing care in a variety of ways. After all, each of our bodies operates — and falls ill — at the hands of its own exclusive biology.

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But van den Brink is hopeful about the possibility of profiling the microbiota to determine how certain bacteria in the gut can influence cancer immunotherapy. "The biome can stimulate T-cells all over the body," he explains. "Maybe we can come up with a strategy to foster a particular type of bacteria in a particular patient that improves treatment response."

Genetic interventions will also play an increasing role in customizing cancer care.

By sequencing not only the genomes of patients, but those of their tumors and even their immune cells specifically, oncologists will be better able to determine which treatments will work best in which patients.

University of Chicago oncologist Jason Luke says oncologists are already trying this.

"Even now we can use genetic techniques to look at which genes are turned on in the cancer tissue and to tell us whether immunotherapy is likely to work or not," he says, explaining that this technique could help identify patients whose immune system is already "primed for attack" and may need only an immunotherapeutic nudge, versus those that might also require chemo and radiation.

Luke also believes that tinkering with DNA using genome editing technologies like CRISPR could help doctors not only excise cancer-causing genes but also improve treatment efficacy. In fact, in June a federal biosafety panel approved the first study of the technique in humans — a study that aims to use the technique to augment cancer immunotherapy by genetically modifying immune cells.

"I think eventually we'll get to the point where we'll look at someone's tumor, immune system and genetics and say, 'This treatment is the way to go,' " foresees Buchbinder. "I think with time, immunotherapy will be part of many, many cancer treatments."

Van den Brink encourages optimistic caution: "We need to be honest here. These therapies look very powerful and promising, but a fair number of patients don't respond to them upfront," he says. "These aren't absolute cures for most people just yet."

Defeating one of humanity's oldest scourges, he says, has years of trial and error ahead.

Bret Stetka is a writer based in New York and an editorial director at Medscape. His work has appeared in Wired, Scientific American and on The Atlantic.com. He graduated from University of Virginia School of Medicine in 2005. You can follow him on Twitter:@BretStetka.

Copyright 2016 NPR. To see more, visit NPR.
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HHS Issues New Rules To Open Up Data From Clinical Trials

NPR Health Blog - Fri, 09/16/2016 - 12:11pm
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September 16, 201612:11 PM ET Heard on All Things Considered Simone Golob/Getty Images

Universities and drug companies that use human volunteers for research face tough new rules designed to make sure that valuable information from these volunteers is widely available, not only to the volunteers themselves but to scientists trying to advance medical science.

The rules currently on the books are confusing and often ignored.

Since 2007, scientists have been required to post results of experiments on a government website, ClinicalTrials.gov. But many top universities and drug companies have failed to meet those standards, according to academic studies and investigative journalists.

"We as a community have had a disappointing track record," said Francis Collins, director of the National Institutes of Health. Collins and other officials are now hoping that will change with clearer, more expansive rules and potentially stinging new penalties put forth by the Department of Health and Human Services.

The new rules, published Friday in the Federal Register, are designed to make it easier for scientists, universities and corporations to understand what experiments must be included in the federal database. It also expands the list of studies that must be registered, to include experimental behavioral interventions — such as a study that compares different diets among diabetics — as well as early-stage (Phase 1) drug trials if they have NIH funding.

Shots - Health News Results Of Many Clinical Trials Not Being Reported

For the first time, these rules also require companies to post results of trials for drugs that don't make it to market, not just the ones that do. "This has been a very opaque world up until to now," Food and Drug Commissioner Robert Califf told reporters during an embargoed phone conference Thursday. "These are tremendous changes."

Researchers must also say in advance how they plan to analyze their results. That is designed to discourage researchers from changing the focus of a study after the fact and dredging through their data to highlight findings that may simply be coincidental, and which might not be robust enough to appear in a study that was specifically designed to look for them.

Clinical trials "are the gold standard for understanding the effect and effectiveness of medical interventions, understanding what works and what doesn't work," Collins said in the press conference.

If information from them is widely shared, it can help scientists identify potentially serious side effects, and it can help scientists avoid wasting federal tax dollars by conducting redundant studies. Right now, scientists often don't report their failures, so other researchers may try the same useless strategy.

Reporting results is also an ethical issue. Millions of patients volunteer to participate in studies, Collins said. "Sharing the results from clinical trials helps fulfill society's responsibility to those individuals who volunteered in these studies with an understanding that their participation will contribute in advancing medical knowledge."

Shots - Health News Medical Studies Involving Children Often Go Unpublished

For studies that are regulated by the FDA, companies can face fines of $10,000 a day if they don't comply with the existing rules. Those fines have not been imposed, however, and the FDA will not have additional funding to hire enforcement staff, Califf said. "I really believe that it won't take much to get people to comply with this once they realize how serious this is."

Collins said the NIH will cajole university scientists to comply as well. If they don't, the NIH would consider withholding funds on planned clinical trials at the offending university until scientists there are following the new rules. This would not apply to research that started before the rules take effect, and the NIH would not stop clinical trials that are already under way.

The new rules come into effect in January 2017. Researchers will have 90 days to comply.

Copyright 2016 NPR. To see more, visit NPR.
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Yes, People Really Are Driving While Playing Pokemon Go

NPR Health Blog - Fri, 09/16/2016 - 11:14am

Sure, you could get run over trying to catch that Zubat. But is it worth it? They're the worst.

Mike Coppola/Getty Images

Pokemon Go trainers will do almost anything for a rare find, including getting into a car and speeding around to catch them. And then they tweet about it. According to a study, there were over 113,000 social media messages in 10 days last July that showed people getting into potentially unsafe traffic situations while trying to catch cute virtual monsters.

One Twitter post came from the Baltimore Police Department, which posted body camera footage of officers talking on the sidewalk late at night on July 18. In a moment, an SUV strikes their parked cruiser and skids down the street.

"Are you OK?" one of the officers says while hurrying up to the car.

#PokemonGO is not all fun and games. Here is a video of a distracted driver who struck one of our cars. #PlaySafe pic.twitter.com/kOTfbTcILo

— Baltimore Police (@BaltimorePolice) July 19, 2016

"That's what I get for playing this dumbass game," the driver replies. He shakes his head at his phone and palms his face.

A lot of people have been dangerously close to getting into similar accidents, according to the study published Friday in JAMA Internal Medicine.

In an effort to plumb how much of a menace players of the wildly popular augmented reality game present, the researchers analyzed 345,433 tweets between July 10 and 19 that contained the words "Pokemon" and "driving, drives, drive" or "car."

You know you've got an honest guy when he feels guilty clicking the "I'm a Passenger" button on PokemonGO while he's driving.

— Miriam (@okmir_) September 10, 2016

Eighteen percent of those showed that someone was playing and driving. Eleven percent suggested a passenger was playing, and 4 percent suggested a pedestrian was playing near traffic.

It's difficult to assess from Twitter just how big the problem is overall. Not everyone uses social media, and of the people who do tweet, not all of them will post about their motor vehicle adventures with Pokemon Go. "[So] we know we're undercounting," says John Ayers, a big data scientist at San Diego State University and an author of the study.

Driving kids home from school....a #Charizard appears! I pulled over to catch him

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Studies Link Cancer Patients' Survival Time To Insurance Status

NPR Health Blog - Fri, 09/16/2016 - 5:00am

Eliminating disparities in cancer care requires more than just expanding Medicaid coverage, say cancer epidemiologists who found that patients with private insurance seemed to have a survival advantage.

Thomas Barwick/Getty Images

Privately insured people with cancer were diagnosed earlier and lived longer than those who were uninsured or were covered by Medicaid, according to two recent studies.

In one study, researchers examined data from more than 13,600 adult patients who had glioblastoma multiforme, the most common type of malignant brain tumor, between 2007 and 2012. The other study analyzed data from more than 10,200 adults who were diagnosed with testicular cancer between 2007 and 2011.

Both studies, published online in the journal Cancer in August, relied on data from the National Cancer Institute's Surveillance, Epidemiology, and End Results program. SEER tracks cancer incidence and survival in the United States.

The two cancers generally progress very differently. Glioblastoma multiforme is very aggressive; patients generally don't live much more than a year following diagnosis and the five-year survival rate is less than 5 percent. Conversely, testicular cancer responds well to chemotherapy even if it has spread to other parts of the body. The five-year survival rate overall is 95 percent.

But regardless of cancer type, patients with private insurance had a survival advantage.

In the testicular cancer study, uninsured patients were 26 percent more likely to be diagnosed with metastatic disease (meaning their cancer had spread elsewhere) than privately insured patients. Medicaid patients were 62 percent more likely to have metastatic disease.

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Though the Medicaid patients fared worse than the uninsured patients in this regard, that might be because, until recently, some of them, too, had been uninsured, the researchers say, and only enrolled in Medicaid after their cancer was diagnosed.

Compared to privately insured men in the study, uninsured men were 88 percent more likely to die of the cancer, and Medicaid patients were 51 percent more likely to die of the disease.

A similar pattern emerged in the glioblastoma multiforme study. Patients who were either uninsured or on Medicaid were more likely to have a larger tumor at the time of diagnosis. An uninsured patient was 14 percent more likely to have a shorter survival time than someone who was privately insured, while a patient on Medicaid was 10 percent more likely to have a shorter survival time, the study found.

There were some treatment differences, as well, between the patients with private insurance, and those who either had Medicaid or were uninsured. And those treatment differences could affect survival.

"We were expecting that the uninsured would do worse than insured patients, but we didn't expect that Medicaid patients would do significantly worse than [privately insured] patients," said Dr. Wuyang Yang, a research fellow at Johns Hopkins University School of Medicine, who co-authored the study about patients with brain tumors.

Sarah C. Markt, the lead author on the testicular cancer study, says she found the Medicaid results in their study striking as well. The findings indicate that eliminating disparities in cancer care requires more than just expanding Medicaid coverage, says Markt, a research associate in cancer epidemiology at the Harvard T.H. Chan School of Public Health. Under the health law, roughly two-thirds of states and the District of Columbia have expanded Medicaid coverage to adults with incomes up to 138 percent of the federal poverty level (about $16,400).

"These are young men dying of a potentially curable disease," Markt says. "There are many opportunities for improvement here."

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter:@mandrews110.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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