TIME Brain

New Hope for Replacing Nerves Damaged by Parkinson’s Disease

Stem cells may provide a new way of regrowing the motor neurons affected by the movement disorder

Reporting in the journal Cell Stem Cell, scientists say that stem cells turned into motor nerves function nearly identically to fetal motor nerves: the kind now used to treat some patients with Parkinson’s disease. That could mean that the stem cells may become an important source of new nerves to replace the ones damaged in diseases like Parkinson’s.

In Parkinson’s, motor nerves that normally produce dopamine, which is critical for regulating muscle movements and controlling dexterity, are damaged, and dopamine levels drop dramatically. The researchers, led by Malin Parmar, an associate professor of regenerative neurobiology at Lund University, took human embryonic stem cells extracted from excess IVF embryos and treated them to develop into motor neurons. They transplanted these neurons into the brains of rats bred to develop Parkinson’s and found that the lab-made cells brought dopamine levels in these animals back to normal levels in five months. The nerves sent out long extensions to connect with other nerve cells in the brain—such networks are important to ensuring coordinated and regulated muscle movements, and without them, patients experience uncontrollable tremors. The effects were similar to those seen when fetal nerves are transplanted into Parkinson’s patients, a treatment currently used to help alleviate symptoms in some patients.

While the results are exciting, it’s just the first step in bringing stem cell-based treatments to human patients. The study did not delve into how well the new neurons functioned and whether they could reverse symptoms of Parkinson’s in the animals. And even if they do improve those symptoms, scientists still have to show that humans could get the same effects. In an editorial accompany the article, Roger Barker of Addenbrooke’s Hospital and the University of Cambridge warned that the exciting possibilities of stem-cell based therapies shouldn’t push scientists—or patients—to expect too much too soon. Before the cells can be tested in people, he writes, it’s necessary to have “a knowledge of what the final product should look like and the need to get there in a collaborative way without being tempted to take shortcuts, because a premature clinical trial could impact negatively on the whole field of regenerative medicine.”

TIME HIV/AIDS

It May Be Possible To Prevent HIV Even Without a Vaccine

"We're removing the doorway that HIV uses to get into cells"

Natural immunity is the most reliable way to protect yourself from viruses, bacteria and parasites. And the best way to acquire such immunity, in most cases, is to expose your immune system to the bug in question—either by getting infected or getting immunized.

Until now, such protection was only possible with diseases like chicken pox or polio. But now, scientists at Harvard University say that people might soon arm themselves against HIV in a similar way, but through a different method.

Chad Cowan and Derrick Rossi, both in the department of stem cell and regenerative biology at Harvard University, and their colleagues report in the journal Cell Stem Cell that they have successfully edited the genomes of blood cells to make them impervious to HIV. In order survive, HIV needs to insert its genome into that of a healthy cell, and to infect these cells, HIV latches onto a protein on their surface called CCR5. If CCR5 is mutated, however, it’s as if the locks have been changed and HIV no longer has the right key; it can’t attach itself and the cells are protected from infection. So the scientists tried a new gene editing technique called CRISPR that allows them to precisely snip out parts of a cell’s genome, and they spliced out the CCR5 gene. To their surprise, the technique was relatively efficient, transforming about half of the cells they treated with CRISPR into CCR5-free, or HIV-resistant, cells.

“It was stunning to us how efficient CRISPR was in doing the genome editing,” says Cowan.

Scientists have previously used CRISPR to make another change in how HIV infects cells; they snipped out the HIV genes that the virus inserted into healthy cells. That process essentially returned HIV infected cells back to healthy ones.

The latest results, however, suggest that the technique may be useful even before HIV gets inside cells. CRISPR could be useful in treating HIV patients if it can replace patients’ own immune cells with the blockaded versions. The cells Cowan and Rossi used were blood stem cells, which give rise to the body’s entire blood and immune system. In order to work as a potential treatment for HIV, patients would provide a sample of blood stem cells from their bone marrow, which would be treated with CRISPR to remove the CCR5 gene, and these cells would be transplanted back to the patient. Since the bone marrow stem cells populate the entire blood and immune system, the patient would eventually have blood cells that were protected, or “immunized,” against HIV. “We’re removing the doorway that HIV uses to get into cells,” says Cowan.

To test this idea, they are already working with another research group to see if the HIV-impervious cells can treat mice infected with HIV.

Because healthy cells would be barricaded from HIV, the process might also lead to a cure for the disease. While the results are currently being tested to treat animals already infected with HIV, it may also be possible to one day transform a person’s immune cell genomes to be protected against the virus. Some people are already fortunate enough to be protected this way—a small percentage of people of European ancestry have natural immunity against HIV because they have two copies of mutated CCR5. They have been well studied and so far, their CCR5 aberrations don’t seem to be linked to any known health issues. “They are totally normal except for the fact that they are resistant to HIV,” says Cowan. “That’s a heartening thing: to have a group of people who are alive today who have been studied and looked at and seem totally fine.”

That’s why clinicians who research the virus and treat HIV patients are excited by the possibilities of CRISPR-aided strategies. If it’s possible to close the door on HIV, then it may be realistic to start thinking about closing the door on the AIDS epidemic in the near future.

Read next: How Meditation May Help People With HIV

TIME ebola

How Guinea Found the Best Way to Survive Ebola

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Seyllou—AFP/Getty Images A medical staff worker of the 'Doctors without Borders' medical aid organization at a center for victims of the Ebola virus in Guekedou, Guinea on April 1, 2014.

As the world waits for new treatments and a vaccine, doctors in Guinea have found the best way to help patients survive Ebola

With the number of cases topping 13,000 and deaths climbing close to 5,000, the current outbreak of Ebola in West Africa is the virus’s worst yet. But from the tragic illness and mortality emerge some important lessons from the region.

The latest, published in the New England Journal of Medicine, details the cases that first appeared in Guinea’s capital city of Conakry between March and April. Unlike in other parts of the region, where the mortality rate from Ebola averages around 60% to 70%, in Conakry it has remained around 43%.

MORE: Here’s What Scientists Know About Ebola in Sierra Leone

Why? As Dr. Robert Fowler, a clinician in pandemic and epidemic diseases with the World Health Organization (WHO) and physician at the University of Toronto, explains, Guinea’s first Ebola treatment center, established in the capital, took a very aggressive approach to handling patients. Working with the humanitarian aid group Medecins Sans Frontieres (MSF) or Doctors Without Borders, the WHO and the country’s Ministry of Health set up a facility where Ebola patients were immediately hooked up to IV fluids and treated for dehydration—often a complication of infection. They were also monitored regularly for changes in their blood chemicals, including the electrolytes that are a marker for whether the body’s cells are getting enough water and nutrients to function. While routine blood work is standard practice at every hospital in developed nations, such testing wasn’t at Conakry health facilities.

“At the beginning of the outbreak, there was no [Ebola] treatment center,” says Fowler. “It evolved from an old cholera treatment facility and the evolution of care went from having no beds to having IVs, IV fluids, antibiotics and antimalarial [drugs]. We were only able to do hand-held point-of-care testing [of blood samples] but that was quite novel for treatment centers anywhere in the outbreak, even though that’s expected and routine almost everywhere else in the world.”

MORE: This Map Will Show You Every Ebola Outbreak in History

The key to helping Ebola patients survive their infection, Fowler and his colleagues saw, was hydrating them with IV fluids, ensuring that their blood work remained stable and addressing any changes in their metabolites as quickly as possible. In the first month of Ebola cases, 37 patients tested positive for the virus, 28 were treated with IV fluids and 16 died. While the death rate remained high, it was lower than that typically seen in other parts of West Africa.

“Our hypothesis has always been that we wanted to establish a culture of very aggressive supportive care for patients who were coming in dehydrated with electrolyte and metabolic abnormalities and try to correct those very early on, so the complications of very severe depletion don’t compound the effects of Ebola virus infection,” Fowler says.

MORE: Why Cuba Is So Good at Fighting Ebola

Fowler is convinced that the key to improving Ebola survival rates is to think about it differently. Instead of thinking of Ebola as an almost-always fatal disease, see it instead as one that is survivable with the right treatments, he says. If people understood that survival is possible—and at higher rates than previously thought—then more people who might be exposed or infected would seek care sooner rather than later, when it’s too late. “I truly do think we can change the way people think about this illness if we evolve the thinking from needing to have isolation facilities…to saying we need rapidly mobilized treatment facilities that can help care for patients with aggressive supportive care as early as possible,” he says.

Even with the dozens of patients he and his team saw at the treatment facility in Conakry, “we just weren’t keeping up with their fluid needs as much as we needed to,” he says. “Collectively as a team, we were thinking we were failing miserably in terms of our goal of delivering optimal care.”

To succeed takes an enormous amount of resources, labor and personnel. Health workers need to routinely draw and measure patients’ blood to track any slight negative changes in their physical state. Fowler acknowledges the need for drug treatments and an effective vaccine, but for now, as thousands of patients struggle to fight off the virus, “we really, really need more health care workers so we can spend enough time with patients and deliver the kind of supportive care that will improve their outcomes,” he says.

MORE: Nurse Explains Why She Fought Ebola Quarantine

Fowler admits the challenges facing recruitment. For starters, working with Ebola patients requires health care personnel to suit up in personal protective equipment that leaves no skin exposed, making them uncomfortable in the equatorial heat of the region. “We are nowhere near hitting the mark that needs to be hit to improve outcomes,” he says. But as data like his starts to build, best practices and the most effective ways to treat Ebola patients are emerging. And hopefully they will start to make a difference.

TIME Developmental Disorders

ADHD Linked to the Air Pregnant Women Breathe

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Alan Hicks—Getty Images Heavy traffic can pollute the air with compounds that can contribute to ADHD

Everything an expectant mother does can have an impact on her baby’s development—including the air she breathes

Research has long connected what a mom-to-be eats and drinks to the health of her baby, and recent studies have even linked behavioral experiences such as stress, sleep and mood to the growing fetus’s development.

Now, scientists reporting in the journal PLOS ONE have pinpointed one exposure that could contribute to a baby’s higher risk of developing attention deficit hyperactivity disorders (ADHD), which the latest data from the Centers for Disease Control show affects around 11% of children aged four to 17 years.

MORE: Early Exposure to Air Pollution Tied to Higher Risk of Hyperactivity in Children

Frederica Perera, director of the center for environmental health sciences at the Mailman School of Public Health at Columbia University, and her colleagues focused in on how the pollutants in the air that pregnant women breathe can affect their babies’ cognitive development. Perera previously found a correlation between polycyclic aromatic hydrocarbons (PAHs) emitted by burning fossil fuels (such as in car exhaust and some forms of residential heating) to developmental delays by age three, reduced IQ in kindergartners and attentional problems by age six. So the team looked specifically at symptoms associated with concentration and evaluated how these effects connected to PAHs might be contributing to ADHD.

The scientists measured the level of PAHs in both the cord blood retrieved when the mothers gave birth and the mothers’ blood following delivery. They also collected urine samples from the children at age three or five years and analyzed them for PAH levels. The children born to mothers with higher levels of PAH during pregnancy had five-fold increased odds of showing symptoms of ADHD than those who were born to mothers with lower levels. The effect remained strong even after the researchers adjusted for the babies’ exposure to air pollution and smoking after birth.

“This is a new finding, and if the PAHs are identified as a contributor to ADHD, that opens up new avenues for preventing ADHD,” says Perera.

MORE: Study Links Exposure to Pollution with Lower IQ

PAHs, says Perera, circulate in the body for a long time, so even brief exposures could contribute to changes in the body. And each person processes the chemicals differently. Some may be more prone to breaking down the compounds into their potentially toxic elements, while others are less affected by the exposure.

While mothers may not be able to control some exposures, such as those from traffic and heating sources, there are some ways that expectant women can reduce their risk. Pushing local legislators to adopt clean air laws is one way to improve air quality, and on a more personal level, families can make sure that cooking areas have proper ventilation, avoid burning candles and incense and other sources of PAHs, and most importantly, ensure that they aren’t exposed to tobacco smoke. “Air quality is a policy problem, but individuals can be empowered to take steps,” Perera says.

MORE: Mom’s Exposure to Air Pollution Can Increase Kids’ Behavior Problems

Women who are pregnant can also eat more antioxidants from sources like fresh fruits and vegetables, since these can counteract some of the oxidative damage that PAHs wreak on fetal cells.

Perera stresses that limiting exposure to PAHs isn’t the only answer to reducing the increasing rate of ADHD in the country. Genetic and other environmental factors all contribute to the disorder, but identifying as many potential factors as possible could start to reduce the effect that the chemicals have not just on mothers, but on their developing babies as well.

TIME Cancer

Promising New Cancer Treatment Uses Immune Cells

A one-two punch is more effective than using two cancer-fighting drugs that boost the immune system against tumors

Cancer researchers are pumping out study after study trying to figure out how best to use the body’s own immune system to fight cancer tumors.

Reporting in the Journal of the American Medical Association, scientists led by Dr. F. Stephen Hodi at Dana Farber Cancer Institute show for the first time that combining two drugs that target the immune system in different ways could help melanoma patients survive longer.

From 2010 to 2011, 245 patients with advanced skin cancer who had not responded to at least one previous treatment were randomly assigned to get a newly approved drug, ipilimumab, designed to help the immune system better target tumors, either alone or in combination with another drug. Ipilimumab (marketed as Yervoy), was among the first anti-cancer medications that allows immune cells to “see” tumors better; since tumors grow from originally normal cells, the immune system often gives them a pass and doesn’t attack them as foreign. But drugs like ipilimumab, called checkpoint blockade inhibitors, help immune cells to look past cancer’s disguise and target abnormally growing tumors.

MORE: A Shot at Cancer

In the study, those who received the combination of ipilimumab and sargramostim, another drug that gives the immune system a laser-like focus on the proteins found on tumors, survived an average of 17.5 months after the study began, compared to 12.7 months for those who took ipilimumab alone. At the end of a year, nearly 70% of those receiving the combination were alive, while 53% of those in the ipilimumab alone group were.

“We show that the combination improves survival, and at the same time decreases side effects,” says Hodi. The patients receiving the two drugs reported fewer gut and respiratory complications, two of the organ systems most affected by checkpoint inhibitor drugs like ipilimumab.

MORE: Why Cancer Drugs May Work Better While You Sleep

The combination, he says, may be more effective since one drug works to suss out tumor cells, like shining a molecular spotlight on them, while the other builds up the body’s defenses against them, allowing immune cells to better target and eliminate cancers.

The time that both groups of patients enjoyed before their melanoma recurred, however, was similar. But Hodi and his team note that the inflammation caused as a side effect of the drugs could be interpreted as early tumor sites, leading researchers to record the presence of tumors that may not be there.

Teasing apart that issue and determining the safe and optimal doses of the combination will require more studies, says Hodi. The dose of ipilimumab he used, for example, was higher than the one approved by the FDA in 2011, since this study was begun before the agency approved the drug. But the idea that a combination of powerful immune-based drugs could help cancer patients fight their disease and survive longer is encouraging. “This world of [new cancer treatments] is moving fast, and there are a slew of possible combinations that others are studying now,” he says. “It’s where the future of cancer therapy will be.”

TIME medicine

Who’s Better at Baby Talk, Mom or Dad?

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ULTRA.F—Getty Images

The latest research shows that moms and dads use baby talk in different ways, and that boys and girls respond to them differently too

In the latest research on how babies first pick up language, it turns out that gender makes a difference.

Reporting in the journal Pediatrics, Dr. Betty Vohr and her colleagues decided to look at how both moms and dads talk to their young babies. Much research has focused on how mothers engage infants, even before they can speak, but fewer studies have focused on the male side of the equation.

Taking advantage of a small recording device called LENA, which they attached to the babies on a vest for 16 hours, Vohr’s team analyzed all of the verbal interactions a group of 33 babies had (none of the babies were born premature). The recordings occurred just after they were born, while the infants were still in the hospital, and again at 44 weeks and seven months. The last two sessions were recorded on days when both the babies’ parents were home.

MORE: How to Improve a Baby’s Language Skills Before They Start to Talk

From more than 3, 000 hours of recordings, the scientists got a good snapshot of the babies’ verbal environments. And the results were both expected and surprising. When babies made sounds, moms were more likely to respond to them verbally than fathers were — “Oooo, sweetie pie, you’re talking this morning.” Mothers responded 88% to 94% of the time to the babies vocalizations, while dads responded only 27% to 33% of the time.

Perhaps because of the increased responsiveness, or because of other reasons, both boys and girls were also more likely to respond to their mothers’ or female voices than they were to male voices.

Vohr says it’s possible that mothers may use more mother-ese — the higher pitched, sing song-y conversational tone that women, more than men, tend to adopt with infants. Mothers may also pair their vocal interactions with more eye contact with the baby, encouraging them to respond more when they hear their mothers’ voices.

“It seems to me that adults talking to children is absolutely the most cost effective intervention a family could do to improve children’s language,” says Vohr, professor of pediatrics at Alpert Medical School at Brown University.

She also found other intriguing gender-based differences. When she compared mothers of girls to mothers of boys, she found that mothers of girls responded more frequently to their babies’ sounds than mothers of boys did to theirs. The same trend occurred for dads; those who had boys tended to respond more frequently to their infants than those who had girls.

“We’re not certain why that is, but the important thing here is knowing that of critical importance in early language development is the need to encourage both parents,” says Vohr. “The more we learn about it, the more we can inform parents of the power they have in just talking and interacting with their infants to improve the long term outcomes for their child and their school readiness.”

Previous studies have documented that the amount of verbal interaction, or “conversations” babies are exposed to even before they can speak, can predict their later language skills and even academic performance in school.

TIME

This Flu Shot Is Not Like the Others

Some people may get a new flu shot that’s made with dog cells instead of chicken eggs

This year Novartis shipped its first full batch of Flucelvax, a new vaccine that was only approved by the Food and Drug Administration in 2012. The company made a limited amount of the shot last year, but there are more doses to go around this flu season. And for the first time, the doses were made at the company’s newly approved U.S. plant in Holly Springs, North Carolina.

The vaccine is made without growing the influenza virus in chicken eggs, which is the way that flu shots were made for more than four decades. Instead, Flucelvax is grown in kidney cells from dogs. The technology means that the shot can be made in less time than a traditional flu shot—enough virus can be churned out in about 65 hours to 75 hours, compared to the six months or so it takes to grow in chicken eggs. It also means that people who are allergic to eggs now have another option for getting immunized against the flu.

MORE: Pregnant Women and the Flu: Why Influenza Is More Dangerous for Expectant Moms

In studies that the FDA reviewed before approving the vaccine, the shot was 84% effective in preventing flu among adults who were vaccinated compared to those who received a placebo. People getting Flucelvax produced around the same amount of antibodies to the influenza virus as those who were immunized with a chicken egg-based flu vaccine.

Using animal cells instead of chicken eggs, say Novartis officials, allows them to have more control over the purity of the final vaccine. How well influenza grows in the chicken eggs is variable—some eggs or batches of eggs help the virus grow, while others aren’t as conducive to producing large amounts of influenza.

The cell-based technology is also a plus during a flu pandemic, since the platform can produce more doses quickly to control an outbreak as a particular influenza virus spreads among a population. The kidney cells are frozen and can be thawed quickly to begin growing virus. The company has produced doses of pandemic flu vaccine against H5N1 using the cell technology, and it’s keeping them in deep freeze as part of the U.S. government stockpile in the event of a pandemic.

The FDA has approved seven different types of flu shots—in addition to Flucelvax and the standard vaccine made from chicken eggs that protects against three strains of influenza, there is also a shot that protects against four strains of flu; for the needle-phobic, one with a microneedle injects just into the skin and doesn’t penetrate into the muscle, making it less painful; for the elderly who need more protection, there is a high-dose vaccine; for younger children there is a nasal spray; and for those allergic to eggs, there’s a shot made from bits of influenza proteins grown in insect cells. Not every doctor’s office or clinic carries every shot, so if you prefer one over the others, call your health care provider to find out if it will be available.

TIME ebola

Here’s What Scientists Know About Ebola in Sierra Leone

An Ebola screening tent outside the Kenema government hospital in Kenema, Sierra Leone, Aug. 6, 2014.
Tommy Trenchard—Redux/The New York Times An Ebola screening tent outside the Kenema government hospital in Kenema, Sierra Leone, Aug. 6, 2014.

Rare, reliable data about Ebola from inside a treatment center in Sierra Leone

Everything we know about Ebola since the disease’s two dozen or so outbreaks since 1976 comes not from a rich, deep database of scientific evidence that’s been carefully collected and recorded. With few formal health care systems in the areas hardest hit by the disease, there were no medical records, no charts and no standardized ways to document patients’ symptoms, vital signs, treatment regimens and whether or not they survived. Instead, much of our knowledge comes from the haphazard scrawl of doctors’ notes and their recollections about treatment and survival rates.

But for the past 10 years at Kenema Government Hospital in Sierra Leone, the country’s Ministry of Health has been working with a group of international researchers to establish a meticulous medical records system—originally for patients with Lassa fever, another common infection in the region. So when the first Ebola patient walked through the door on May 25, the same procedures for documenting vital signs and treatment information stayed in place. Now, for the first time, doctors have a robust record of the first Ebola patients in the current outbreak treated at Kenema beginning in May—and the results of that record-keeping appear in the New England Journal of Medicine.

MORE: Ebola Tests Fast Tracked By FDA

The new records were a challenge to collect, since infection control rules meant that the paper charts could not be transferred back and forth between the ward where patients were treated and other areas of the hospital. “The nurses’ station was separated from the patient rooms by essentially a chicken wire window, so the nurses would talk to each other through the chicken wire—the nurse inside, in personal protective equipment, would tell the nurse outside what to write down,” says paper co-author Dr. John Schieffelin, an assistant professor of clinical pediatrics and internal medicine at Tulane University who has been serving stints at the hospital for the last four and a half years. Even that rudimentary system was state of the art for the region, where most health clinics do not keep medical records. “In most of Sierra Leone, the hospital chart is one of those little composition books that we used to write essays in during high school,” says Schieffelin. “There was no structure to it; the physician would just write daily notes and most hospitals don’t have a charting system.”

MORE: See How Ebola Drugs Grow In Tobacco Leaves

The new documents confirm what previous health workers knew about Ebola from experience. Of 106 patients with Ebola, 44 had complete medical charts in paper form (the rest were destroyed because health officials feared they had been contaminated with the virus), and the findings supported some basic tenets of Ebola infection: that the incubation period for Ebola virus is about six to 12 days, that 74% of those infected died, that younger patients were more likely to survive infection than those over age 45, and that people with less virus in their blood when diagnosed were more likely to survive.

“It affirms our understanding of how to treat Ebola patients,” says Schieffelin. “We need to treat them aggressively with IV fluids and monitor their blood chemistries. The study also gives us a good solid baseline for understanding the disease, so we can build on it in a lot of different ways. It’s a foundation for doing further studies for optimizing treatment. It provides a great foundation for studies looking at novel treatment methods. Now that we understand how Ebola affects patients, can we improve symptoms and outcomes with novel therapies? We can start to ask and answer those questions.”

MORE: 12 Answers to Ebola’s Hard Questions

Turning those answers into new treatment strategies, however, might be a daunting task—especially in the context of the current outbreak. On most days, the Kenema hospital would see about 90 Ebola-related patients, some of whom were suspected to have the disease but still needed to be tested, and others with confirmed infections who needed to be immediately assigned to a bed and given IV fluids. “There are a lot of confused Ebola patients,” says Schieffelin. “These people are wandering around the ward, often going from one bed to the next, and they are scared so often not very cooperative. To top that off, a lot of people didn’t speak English, so that made it even more challenging.”

He admits to often tossing patient confidentiality concerns aside by asking other patients who were feeling well to translate critical information to their peers, who either didn’t need to be in the hospital any longer because they tested negative, or needed to be immediately transferred to another ward if they were infected.

MORE: Learning From Past Viral Epidemics, Asia Readies for Possible Ebola Outbreak

At Kenema, the health care workers did not use the full-coverage hazmat suits that Medecins Sans Frontieres uses in its clinics. Instead, they wore Tyvek suits that covered their front and back, a mask, face shield, double gloves and a head covering. That left some skin in the front and back of the neck exposed. The reason was partly for practical reasons—Schieffelin was often the only health care worker on his part of the ward where patients were triaged, and frequently had to spend four to four and a half hours at a time suited up. The full coverage suits become uncomfortable and unbearable after about 45 minutes.

“But I was personally okay with our equipment,” he says. “Because my biggest concern was getting a needle stick. My mucous membranes—my eyes, nose and mouth—were pretty well covered.”

After about four hours, he and whoever else was working on the wards with the infected patients would get sprayed with a bleach solution from the shoulders down, in order to avoid splashing any potentially contaminated material onto their face and neck. Then they would take each piece of equipment off and wash their hands in bleach after each step. After a break of an hour or so, they would suit up again.

MORE: Ebola Quarantines ‘Not Grounded on Science,’ Say Leading Health Groups

When Schieffelin returned from his work in Sierra Leone in August, he was told by the World Health Organization, U.S. Centers for Disease Control and the Louisiana state health department (he lives in the state) to monitor his temperature twice a day for 21 days, which he did. He was also told not to use mass transportation. He worked at home for a couple days, only because he was exhausted after his trip, and when he returned to work he didn’t see patients for a few weeks—mostly out of a scheduling coincidence, not intentionally.

Given public concerns about Ebola potentially coming to the U.S. and spreading here, however, he says, “Perhaps we should say that in terms of physicians and nurses, maybe direct patient care for a couple of weeks would not be in anyone’s best interest.”

But while he recognizes that hospital organizations and the general pubic have legitimate concerns about being protected against an agent as deadly as Ebola, Schieffelin is against mandatory self-isolation or quarantine, measures the states of New York and New Jersey recently decided to require for all health care workers returning from the three countries affected by Ebola. “I think self-isolation is completely unnecessary if you are not symptomatic. In my mind, that enhances hysteria. I have young children. If their dad were in self isolation away from everybody for three weeks, that would adversely affect them and would be telling the community and the schools the wrong message: that I need to be a pariah and an outcast for three weeks,” he says. “In my mind, that’s not the right message. If I have no symptoms, I am not a threat to anybody—I’m not a threat to my children, nor are my children a threat to other children at their school.” Such mandatory quarantines could also deter health workers from contributing to the effort to control the epidemic, and that will only prolong it, he says.

Schieffelin says that if he had recorded a fever at any point during this 21 day monitoring period, he would have immediately reported to the Louisiana health department and gone into isolation. He knows how deadly Ebola can be from personal and professional experience: seven of Schieffelin’s co-authors on the paper have died of Ebola infection since the data were collected over the summer.

TIME ebola

Ebola Tests Fast Tracked By FDA

Two new tests that can rapidly detect Ebola are now being shipped to hospitals around the country

The Food and Drug Administration (FDA) approved two new diagnostic tests that can detect Ebola from blood, urine or saliva samples in as little as an hour. The tests are made by BioFire Defense, a Salt Lake City-based company, and can be used in the company’s FilmArray machine, a device that can look for Ebola virus genes in the blood. In the U.S., 300 hospitals already use the machine to detect a range of infectious agents.

One test is designed for commercial use in hospitals and laboratories, while the other is approved only for labs designated by the Department of Defense.

The company said it sent a FilmArray machine with the newly approved Ebola kit to Bellevue Hospital, where Dr. Craig Spencer, the fourth person to be diagnosed with Ebola in the U.S., is being treated. But because the approval came so quickly, and the device was rushed to the hospital at the FDA’s request, proper New York city and state regulations have not been met yet, so the machine is still not in use. The company says the paperwork should be completed soon. “We are working through the process of being able to deliver [it] to Bellevue Hospital and hope that happens soon,” says Kirk Ririe, CEO of BioFire Defense, which worked with the U.S. military to develop the Ebola test kit. “We just got out ahead of ourselves.”

MORE: Ebola Quarantines ‘Not Grounded on Science,’ Say Leading Health Groups

The two tests were approved under the agency’s Emergency Use Authorization powers, which allows the FDA to permit use of unapproved tools or drugs to be used to diagnose, treat or prevent “serious or life-threatening diseases or conditions caused by [chemical, biological, radiological or nuclear] threat agents when there are no adequate, approved and available alternatives.”

While quick diagnosis of Ebola is critical to identifying patients infected with the virus and providing them with health care that can save their lives, officials at Doctors Without Borders (Medecins Sans Frontieres, or MSF) say that the BioFire tests do come with some disadvantages in the field. Currently, lab technicians use a gene-based assay to pick up genetic fingerprints of the Ebola virus. The test takes four hours, but the current technologies can run multiple samples from different patients at the same time, allowing clinics like MSF to test up to 70 people a day. While the BioFire platform can spit out results in one hour, it can only run one sample at a time, so to maintain the high volume of testing at outbreak centers, says Erwan Piriou, laboratory advisor at MSF, “we would need multiple devices to reach the same throughout in a day. I feel in that sense the device doesn’t solve everything.”

That could be tricky in the resource-poor settings where Ebola typically emerges. Each machine costs around $39,000, and the price of each test is about $189.

MORE: WHO: Ebola Cases Exceed 10,000 Worldwide

The big advantage to the BioFire platform, however, is that it requires less handling of the samples that could potentially be infectious. At field clinics in West Africa, testing currently occurs in small tents or facilities outside of the Ebola treatment areas. Ebola treatment areas require health care workers to don full personal protective equipment that reveals no skin that could potentially be exposed to virus. Health care workers draw blood and sterilize the outside of the vial with chlorine to kill any virus that may have contaminated it. The vial is then brought to the testing area, where technicians work in glove boxes—transparent, sealed boxes with built-in gloves so that technicians can destroy the virus. Once the virus is deactivated, the sample is put through a molecular process to amplify the viral genes and then analyzed for presence of Ebola RNA.

The BioFire platform, while welcome, is also a bit of overkill for the immediate needs of the Ebola health care community in West Africa. It was designed to test for an array of pathogens—from malaria to anthrax—so the cost includes the ability to test for all of those agents, which isn’t urgently needed in West Africa.

A diagnostic that can quickly detect Ebola—or rule it out in cases of diseases like malaria—is critical for containing the outbreak and maintaining strong health care in the region, even as the outbreak peters out in coming months and years. “It’s the malaria season now, and what is happening is that some non-Ebola cases need to be treated as well,” says Dr. Arlene Chua, policy advisor on diagnostics for MSF, citing patients with undefined fever or post-partum bleeding. “Health care workers are afraid they might have Ebola, so we need to a test to exclude Ebola quickly so we can take care of non-Ebola cases.”

MORE: Study: Current Aid Promises Won’t Contain Liberia’s Ebola Outbreak

WHO is soliciting submissions from companies interested in receiving expedited approval from WHO for their diagnostics; some have been in development for years but have stalled because of lack of funding. From MSF’s perspective, top priorities in an Ebola test would include a device that can take smaller samples of blood—such as from a finger stick rather than a blood draw, which exposes health care workers to more risk of infection—or samples of saliva. Also helpful would be a device that remains completely contained that does not require technicians performing the test to wear personal protective equipment, and lower power requirements, such as a battery, that can be recharged so the test can be used anywhere and under any conditions.

Those are tall orders, but such a dream diagnostic should be possible, says Piriou. “The BioFire technology is amazing technology for sure. So the technology is there,” he says. “It’s not more or less difficult than developing a test for any other disease. There is no reason it can’t happen.”

TIME Cancer

This Mammogram Saves Lives and Money

Dubin Breast Center Of The Tisch Cancer Institute At The Mount Sinai Medical Center Ribbon Cutting & Opening
Gary Gershoff—Getty Images A 3D mammogram machine at the Tisch Cancer Institute at Mount Sinai Hospital in New York City

A screening combo may be worth it for women with dense breasts

More hospitals are offering women the latest technology in mammography: machines that can recreate breast tissue in 3D to help doctors better detect the earliest cancers. But it’s still not clear whether these screens, which cost more than digital mammograms, are worth the money.

In a study published in the journal Radiology, researchers led by Dr. Christoph Lee at the University of Washington found that for women with dense breasts, who often need repeat mammograms, adding on 3D screening—called tomosynthesis—to a traditional digital mammogram actually costs less in the long run.

MORE: High-Tech 3D Mammograms Probably Saved This Woman’s Life

Women with dense breasts are at moderate to high risk of developing breast cancer because of the volume of breast cells in their tissue, and Lee’s team created a model for these patients to compare the cost effectiveness of digital mammography every other year to digital mammography with 3D screening every other year. Using data from the National Cancer Institute’s Breast Cancer Surveillance Consortium, the researchers calculated breast cancer rates and deaths using both screening methods, and found that for every 2,000 women with dense tissue who were screened, the 3D and digital test avoided one additional death from breast cancer compared to the digital mammography alone.

Just as importantly, says Lee, the model predicted that the two screening methods together averted 810 false positive readings. Fewer false positives means that women won’t get as many repeat scans and will be less likely to have biopsies and other procedures to learn more about any suspicious growths.

“The savings represented by 810 fewer false positives are a huge savings in anxiety, diagnostic workup and resource utilization in the health care system,” says Lee. “The decrease in false positives is what is driving cost effectiveness and showing that the benefits of adding tomosynthesis outweigh the added costs of the technology.”

The findings support a study published earlier this year that showed for the first time that 3D mammography detected more cancers, while reducing the false positive rate in a broader group of women even without dense breast tissue.

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