Experts weigh in on consumption of genetically modified salmon

first_imgFirst OpinionExperts weigh in on consumption of genetically modified salmon AG: It would be great if we could eat only wild native fish. But fish stocks are declining. This genetically modified salmon offers a good, environmentally sound alternative.My one concern is how these animals will be raised. It’s impossible to know “What does a salmon want?” As long as the genetically modified salmon, and other farm-raised salmon for that matter, are grown in a humane way that doesn’t create environmental problems and that avoids the use of antibiotics, which is creating a public health disaster for us, then I think they represent a step forward.What makes the AquAdvantage salmon different from a regular Atlantic salmon?AVE: The AquAdvantage carries a growth hormone gene from a Pacific Chinook salmon. It also has regulatory pieces of a gene from the ocean pout, a fish that lives off the coast of New England and eastern Canada. In the pout, these regulatory pieces control the expression of an antifreeze protein in the pout’s blood to let it survive in near-freezing water. The additions to the AquAdvantage salmon’s genes generate growth hormones in response to cold temperatures. As a result, the fish grows in cold water at a constant rate throughout year, and can get to market size in about half the time it takes conventional salmon and using 25 percent less feed. Other than that, analyses by the FDA show that the genetically modified salmon does not differ from non-modified, farmed Atlantic salmon.How does the FDA determine that a genetically modified organism is safe to eat?AVE: The FDA determines safety by compositional analysis. Basically, it grinds up samples and evaluates what is in them. In these analyses, the genetically modified salmon and wild Atlantic salmon were not different. The FDA also determined that the new protein in the AquAdvantage salmon didn’t cause allergies. Of course, if you are allergic to fish, don’t eat this one or any other salmon. In reality, there’s no such thing as a completely safe food — no matter what breeding method was used to produce it. So what the FDA scientists really determined was that the food from the AquAdvantage salmon was as safe as food from conventional salmon.Weren’t there concerns about growth hormone and allergens?AVE: Before and after the September 2010 FDA hearing on the AquAdvantage salmon, several interest groups claimed that this fish carried higher levels of a growth hormone called insulin-like growth factor 1 (IGF-1) than wild Atlantic salmon, and that it was more likely to cause allergic reactions. These allegations were from cherry-picked data. The amount of growth hormone was too low to measure in all of the AquAdvantage salmon samples, while the amount of IGF-1 was too low to measure in most of the samples. Even if individuals ate a lot of the genetically modified salmon, it wouldn’t significantly increase the amount of growth hormone and IGF-1 they consumed.We eat growth hormone and IGF-1 from different animals all the time. But we digest these proteins so they can’t affect the body.When it came to allergy-causing proteins, the FDA concluded that the genetically modified salmon didn’t present a new risk of allergic reaction to salmon-allergic individuals and isn’t likely to cause new allergic reactions.Are there environmental concerns? What would happen if the AquAdvantage salmon got into the wild?AVE: The company designed its production systems to make it extremely difficult, if not impossible, to escape. There’s a biological barrier — the fish are all female and sterile. There are also physical barriers. The salmon are hatched at a facility in Canada. Screens prevent their escape and the hatchlings would not be able to survive in the highly salty water surrounding the facility. The fish are then raised in a land-based facility in Panama, and could not survive in the warm streams and lakes around it.Were you surprised that the FDA approved this genetically modified fish?AVE: No. But I am surprised at how long it took. The company provided the proof of concept more than a quarter of a century ago, and formally started the review process with the FDA in 1995. After a public meeting in September 2010, which followed AquaBounty’s unprecedented voluntary public release of all of the regulatory data about this genetically modified animal, I was certain that the FDA would approve it. At that time, FDA reviewers unanimously concluded that this food was as safe as conventional Atlantic salmon. What’s been happening in terms of finally making a decision in the five years since then is a mystery.Alison Van Eenennaam is an animal biotechnology specialist at the University of California, Davis. She was a subject matter expert when the FDA Veterinary Medicine Advisory Committee evaluated the AquAdvantage salmon in September 2010. Alan Goldberg, PhD, is a professor of toxicology and principal investigator in the Global Food Ethics Initiative at the Johns Hopkins University. Patrick Skerrett [email protected] After a 20-year review, the FDA just approved the first genetically modified animal for Americans to eat. But don’t expect to see the AquAdvantage salmon, created by AquaBounty Technologies of Waltham, Mass., in grocery stores or restaurants any time soon. Even barring legal challenges, which have already been threatened, it will likely take two years to get the fish to market.I talked about this fish tale with Alison Van Eenennaam, an animal biotechnology specialist at the University of California, Davis, who has been following the AquAdvantage salmon story for several years. I also chatted with Alan Goldberg, who is with the Global Food Ethics Initiative at the Johns Hopkins University.Is genetically engineered food risky?Alison Van Eenennaam: We’ve been genetically selecting food species, both plants and animals, since Adam was a boy. The risks of genetic engineering are no different than the risks of doing the same thing with selective breeding.advertisement Alan Goldberg: Every animal we consume for food has been modified one way or another over millennia. Genetic engineering is just another way to do it. Compare pictures of beef cows from today with images of beef cows in the 1700s. They look like different species. Today’s industrial turkey has been bred for so much breast meat that it can barely stand up and can’t have normal intercourse. I see nothing wrong with eating genetically modified fish or other animals.If the AquAdvantage salmon makes it to the marketplace, would you buy it?AVE: In a heartbeat. Compared with traditionally farmed Atlantic salmon, I’d buy the AquAdvantage because I believe it is environmentally superior to conventionally farmed salmon. It requires less feed over its lifetime. That significantly reduces the environmental footprint of raising fish for food. I’d also buy it because I support innovation in agriculture.advertisement By Patrick Skerrett Nov. 20, 2015 Reprintscenter_img @PJSkerrett Editor, First Opinion Patrick Skerrett is the editor of First Opinion, STAT’s platform for perspective and opinion on the life sciences writ large, and the host of the First Opinion Podcast. About the Author Reprints The FDA on Thursday approved the first genetically modified animal to be marketed as food for Americans — the AquAdvantage salmon. Peter Parks/AFP/Getty Images Tags FDAgenetically modified organismsnutritionlast_img read more

Johnson & Johnson faces Oregon lawsuit over ‘phantom recall’ of Motrin

first_img @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. The goal was to obtain data that J&J hoped would convince the FDA that a formal nationwide recall wasn’t needed. However, J&J initially failed to notify wholesalers and retailers about the defective Motrin and when the episode later came to light, J&J executives were asked to testify at a congressional hearing.In their lawsuit, Oregon state officials contended the phantom recall — as it came to be known — failed to accomplish its goals. By the time J&J contractors “actually executed their secret buyback project [throughout 2009], 95 percent of the units distributed in Oregon that could have contained defective Motrin had already been sold to consumers,” the state contended in court documents.It wasn’t until February 2010 that J&J notified wholesalers and retailers in Oregon they had sold defective Motrin. On that basis, Oregon state officials charged the health care giant misrepresented the effectiveness of its product and, ultimately, that consumers were at “material risk,” as a result.For its part, J&J argued it did not violate the state’s trade practices act because there was no proof that defective Motrin was ever sold in Oregon. It was on that basis that a state court judge dismissed the lawsuit. But the appeals court disagreed. “A material risk that a product has a latent defect is exactly the kind of inherent feature of a product” that is protected under the law, the court wrote in its 15-page opinion.In a brief statement, Oregon Attorney General Ellen Rosenblum said the “opinion is a powerful affirmation of Oregon’s consumer protection laws.” J&J said it that will appeal.To what extent the lawsuit will impact J&J at this point is unclear. Meanwhile, the health care giant has, over the past year, largely resumed operations, notably at a key facility in Fort Washington, Pa., where its over-the-counter medicines division — known as McNeil Consumer Healthcare — is based. A phantom recall continues to haunt Johnson & Johnson.An Oregon appeals court last week revived a 2011 lawsuit brought by state officials who claimed the health care giant exposed consumers to defective supplies of the Motrin pain reliever and violated the state’s unlawful trade practices act.The move comes five years after J&J reached a deal with the federal government — known formally as a consent decree — to upgrade several manufacturing facilities in the wake of severe quality-control problems. Such agreements require companies to meet certain standards before the Food and Drug Administration will permit shipments to resume.advertisement Oregon last week revived litigation against Johnson & Johnson. Mel Evans/AP Ed Silverman PharmalotJohnson & Johnson faces Oregon lawsuit over ‘phantom recall’ of Motrin center_img About the Author Reprints [email protected] The manufacturing gaffes were widely publicized because they led to a long-running string of product recalls, some of which were handled poorly, sullying the company’s storied reputation among consumers and physicians. And many J&J shareholders filed lawsuits, one of which unsuccessfully sought to hold the company’s board of directors responsible for a lack of oversight.One episode, in particular, proved troublesome for J&J. In 2008, the company discovered that a batch of Motrin pills made at a plant in Puerto Rico failed to dissolve properly. Instead of issuing a recall, a J&J contractor surreptitiously attempted to retrieve large amounts of Motrin by using “secret shoppers” to buy bottles from around 5,000 stores in the US, including a few dozen in Oregon.advertisement By Ed Silverman Nov. 30, 2015 Reprints Tags FDAJohnson & JohnsonMotrinlast_img read more

Seeking an edge, these brain hackers mix up risky chemical cocktails for breakfast

first_imgPoliticsSeeking an edge, these brain hackers mix up risky chemical cocktails for breakfast By John M. Glionna Feb. 19, 2016 Reprints They haven’t been clinically proven to work, and there’s emerging evidence that some could be dangerous. But nootropics, also called smart drugs, have become popular among young type A personalities on Wall Street, in the Ivy League, and here in the frenzied startup culture of Silicon Valley. Can we ‘cure’ aging? Scientists disagree Dietary supplement use among soldiers, athletes raises concern SAN FRANCISCO — Tomás Gutiérrez  isn’t a brain scientist. But each morning, he mixes up a new chemical cocktail that he hopes will sharpen his focus and boost his intellect.He adds a dash of butter for flavor, stirs it into a cup of coffee, and downs it.A 31-year-old entrepreneur, Gutiérrez has thrown himself into the emerging movement of body hacking — or, more precisely, brain hacking. He’s a connoisseur of “nootropics,” a broad category that includes pharmaceutical drugs, dietary supplements, and do-it-yourself concoctions, all of them meant to turn the brain up a notch.advertisement Enthusiasts aren’t seeking an altered state of consciousness; they want to become a better version of themselves, even just for a few hours at a time. Like Olympic athletes pushing their bodies, they hope to tune their brains for peak performance. And they want to do it without the jittery side effects and stomach churn they’d get from downing endless energy drinks or popping prescription stimulants like Adderall or modafinil.advertisement [email protected] Tags braindietary supplementsFDApolicywellness Related: “It’s a level of focus otherwise unheard of, one you can maintain for long periods of time.” “Just because it’s natural, that doesn’t mean that it’s safe.” About the Author Reprints Dietary supplement manufacturers face flurry of federal charges center_img Kamalini Mukerjee, registered dietician Nootrobox has begun trials to test the long-term effects of its products, which sell for about $40 for a month’s supply. But Woo knows many brain-hackers are too impatient to wait for the future. “A lot of people have this intellectual curiosity, trying the more edgy stuff to boost their brains — it’s all about getting comfortable with the risks,” he said.Rave reviews, and dire warnings, onlineMany are experimenting with drugs such as piracetam and noopepts, which are sold under brand names such as OptiMind and NeuroFuse. Online forums are filled with comments from people who credit the chemicals with helping them achieve new clarity of mind and finish tasks at a record pace — and also with warnings from users who said the drugs made them feel foggy and leaden, or caused alarming side effects.Jens, a 22-year-old advertising student at the breakfast, said his daily doses of piracetam and a nutrient called choline, added to his coffee, often induce a Zen-like state.“I can get so deep into something that I forget about the world around me,” said the Swedish native, who asked that his last name not be used because he didn’t want his family to know he was experimenting with the substances. “You become one with whatever you’re doing … I can think deeper and faster. It’s not happier, it’s just more focused.”Joe Cohen is another proponent of pushing the brain’s envelope. He’s a New York City-area nutritional consultant and bio-hacker who started the website selfhacked.com to chronicle his adventures with nootropics and other substances.While he advises caution to readers, Cohen admits having a few of his own fast-lane practices.“I do megadose experiments,” he said. “It’s a curiosity thing with me. If you really want to know the effect something has on your body, you often can’t tell by taking a normal dosage.”And so he sometimes compounds the recommended dosage. “The brain is resilient,” Cohen said. “It will go back to normal if you don’t go too hardcore.”Registered dietician Kamalini Mukerjee, who’s based in Las Vegas, counters that it’s dangerous to play scientist with your own brain, even with supplements labeled as natural. “People die from peanut allergies. Just because it’s natural, that doesn’t mean that it’s safe,” she said.Gutiérrez makes and consumes a coffee beverage with butter, cream, and powdered coconut oil every day. Jason Henry for STATQuestioning the rat raceGutiérrez swears by the mental boost he gets from his stacks.Still, he sometimes questions his own reasons for needing such a drug regimen, wondering whether work pressures have forced him to become his generation’s version of a hamster scurrying on an exercise wheel.“I don’t think human beings are designed for the hyperproduction that is a product of this modern age,” he said. “With so many of those hours-long stretches of hyperbrain activity, I’ve burned myself out so many times.”Gutiérrez has tried other ways to increase his mental acuity and his sense of well-being. He’ll sometimes fast for up to 40 hours straight. He sticks to a mostly Paleo diet consisting of meat, fish, and vegetables. He has also tried meditating, getting more sleep, and even taking more time off from work.He’s learned, he said, “that there’s more to be found in the enjoyment of life than chasing productivity.”But he still pours his stack into his coffee each morning, hungry for brain overdrive. Gutiérrez, slender and dark-eyed, swears by a daily “stack” mixed into his morning coffee.He throws in some MCT oil, a form of fatty acid that occurs naturally in such foods as coconut oil. He adds BCAAs, or branched-chain amino acids, which are popular among weightlifters. Then there’s L-theanine, an amino acid found in green tea.‘Breaking Bad’ on the kitchen counterOn the kitchen counter of the two-bedroom house he shares with his girlfriend, Gutierrez keeps 100-gram containers of compounds he buys online, along with two scales, one to measure in grams and the other in milligrams.Sometimes, his girlfriend prods him to clean up his experiment site. She thinks it looks too much like a chemistry set. And Gutiérrez admits his kitchen resembles a scene from “Breaking Bad.” “It definitely looks questionable,” he said. “There are liquids and powders and scales.”Like all dietary supplements, nootropics are only very loosely regulated; the manufacturers don’t have to prove safety or efficacy before putting them on store shelves. By law, the Food and Drug Administration can step in to recall a product only if it’s mislabeled or causing illness or injury.Gutiérrez admits that a part of this untested new drug realm scares him. A skeptic by nature, he says he fully researches any compound he puts in his body. But he acknowledges that not everyone follows that protocol.“You’re on your own to figure out the safety of some of this stuff,” he says. “People might say the negatives are few, but we still don’t know what we don’t know.”A competitive squash player, Gutiérrez says his daily stack gives him a feeling of concentration and productivity known among his fellow brain-hackers as “The Flow.” @jglionna Related: The other day, Gutiérrez was among a dozen brain-hackers — mostly lawyers, students, and tech engineers — who attended a breakfast at a coffee house near San Francisco’s financial district.The host was Geoffrey Woo, a Stanford computer science graduate who cofounded Nootrobox.Woo passed around a jar containing Go Cubes, bite-sized chews containing caffeine and L-theanine. It’s the latest Nootrobox cognitive enhancer. Gutiérrez took one and began to chew. “It’s good,” he said. “Tastes like coffee.”Woo believes companies like his may be on the verge of providing not only a brain boost but a key to prolonged life. “We are all trained as children that we are going to die,” he said, “but technology is reaching a point where death can be treated like any illness or sickness, and aging will be considered a disease.”(For all his confidence, the Nootrobox website does include a warning that the company cannot “ensure that unforeseen side effects will not occur even at the proper dosages” and is not liable for any such fallout.) “It’s a level of focus otherwise unheard of, one you can maintain for long periods of time,” said Gutiérrez, a partner in a startup that creates and markets teams of tech talent. (He also runs an online coffee sales business.) “You can crank out code or do some other technical task for hours on end.”A host of companies now sell over-the-counter nootropics, and they’re starting to get big-name backing. Nootrobox, a startup based here in San Francsico, has financial backing from Yahoo Chief Executive Marissa Mayer and the legendary venture capital firm Andreessen Horowitz, which is known for its early bets on Twitter, Airbnb, Instagram, and other blockbusters. Related: John M. Glionna Tomás Gutiérrez prepares his daily nootropic coffee beverage with butter, cream, and powdered coconut oil. Jason Henry for STAT But Gutiérrez belongs to an active community of amateur scientists who like to experiment with their own mixes — and aren’t afraid to use their own brains as lab rats. They trade precise combinations of plant extracts and synthesized drugs as though they were swapping cookie recipes.To give some idea of the popularity: The nootropics page on Reddit, which serves as an online forum for the do-it-yourself-crowd, has more than 65,000 readers.Gutiérrez measures out ingredients for the beverage. Jason Henry for STATTroubling hints of risks to the brainDo the chemical cocktails work?“Who the heck knows?” said Kim Urban, a Philadelphia neurophysiologist who has studied the effects of nootropics. “So few studies have been done, and those that have were not the most controlled trials.”Urban said there are hints of short-term gain but also signs that overuse could cause damage, such as muscle spasms and brain fog.A study she coauthored, which was published in 2014, found that stimulants such as Ritalin — often favored by brain-hackers — could eventually reduce the plasticity of the brain’s neural pathways and potentially cause long-term harm. She found particular risk for children and adolescents, but wrote that even healthy adults run a risk.“You’re dealing with unregulated substances that have no oversight,” Urban said. “Myself, I wouldn’t take them. I’d be leery of them the same way I’d avoid taking weight-loss supplements. We just don’t know enough.” Tomas Gutierrez, brain-hacking enthusiastlast_img read more

CDC urges pregnant women to avoid area of Miami where Zika is spreading

first_img @DrewQJoseph By Helen Branswell and Andrew Joseph Aug. 1, 2016 Reprints “Nothing that we’ve seen indicates widespread transmission, but it’s certainly possible there could be sustained transmission in small areas,” Frieden said during a briefing for reporters.“This is particularly a risk for people who don’t have screens or air conditioning and who live in crowded spaces.”advertisement MIAMI — For months now, the Centers for Disease Control and Prevention has been warning pregnant women not to travel to several dozen countries where the Zika virus is spreading. On Monday, the Atlanta-based agency cautioned American women who are pregnant not to travel to a part of the United States.CDC Director Dr. Tom Frieden urged women who are pregnant to avoid a roughly one-square-mile section of Miami-Dade County where it is believed local mosquitoes are transmitting Zika. He said he believed it marked the first time the CDC had issued a health-related travel advisory for the mainland United States.The CDC has been warning for months that some local transmission of Zika in the 50 states was likely, though it has insisted aspects of the US lifestyle — houses with screened doors and windows, homes and vehicles with air conditioning — should lower the risk of large outbreaks.advertisement Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. @HelenBranswell Florida Governor Rick Scott announced that he has asked the CDC to send an emergency response team to help Florida’s department of health with its investigation and mosquito control efforts. Previously the state had only asked the CDC to provide it with the services of an expert epidemiologist. By Tuesday, the CDC’s team in Florida will include eight experts, Frieden said.Wynwood is home to a large Puerto Rican community. Officials here say they have enlisted community organizations to help spread information about the virus and mosquito control.“Everybody’s concerned about it,” said Luis De Rosa, the president of the South Florida Puerto Rican Chamber of Commerce. “Education has been the key to all of this.”The chamber is located in the area where officials believe Zika has been transmitted, but De Rosa said he hasn’t heard from anyone that they are avoiding the area.The week-old outbreak is already larger than Florida’s earlier experience with another mosquito-spread virus, chikungunya. In 2014, a dozen people in Miami-Dade, and neighboring Broward, Palm Beach, and St. Lucie counties contracted chikungunya, which causes more severe illness than Zika but is not linked to birth defects.Of the 10 new Zika cases, six had no symptoms and were identified through a door-to-door survey the department of health is doing to assess how far Zika has spread. The statement did not indicate the genders of the people. And Florida has not revealed if any of the people infected locally are pregnant women.Dr. Karla Maguire, an obstetrician-gynecologist at the University of Miami who is 13 weeks pregnant, said Zika has “hit home both personally and professionally.”For months, Maguire, who does not live in Wynwood, has been talking about Zika with her patients and what they could do to minimize their risk. She was also taking precautions herself: wearing long sleeves and pants and applying mosquito repellent, and forgoing the long nightly walks on the beach that she did during a previous pregnancy a few years ago.Now, she said, “it’s not as abstract.”With local transmission confirmed, Maguire said she is putting on more repellent every day and spending less time outdoors. She said her patients seems to be responsive to her advice, but that she has had to tell them that it is safe for them to use DEET during their pregnancies and that it is the most effective way to keep mosquitoes at bay.One challenge with Zika, Maguire said, is that so much is not known. Women in their third trimesters want to know if they’re safe, for example. And while experts think fetuses in the first trimester are most vulnerable, they aren’t sure what kind of longterm effects there might be for a fetus infected with Zika during the third trimester.Aedes aegypti mosquitoes are found throughout Florida and other states on the Gulf Coast. Although the virus typically generally causes only a mild illness — and often no symptoms at all —  it can cause serious birth defects in fetuses when it infects pregnant women. Blanca Che, 45, who lives in a pocket of Wynwood full of single-story homes, said she had seen crews going door to door several times in the past week distributing fliers about mosquito control and Zika. She said the crews had been knocking on doors and returning later if no one answered.She said her family always made sure to empty any standing water in the yard. She said she wasn’t that concerned about Zika in her neighborhood because she knew it would never spread like it has in Latin America.“We’re taking all necessary precautions,” she said as she took out the trash, wearing a tank top and shorts.On Monday morning, De Rosa, of the South Florida Puerto Rican Chamber of Commerce, walked through a park in the neighborhood named after legendary Puerto Rican baseball player Roberto Clemente to make sure there was no litter that could be collecting water and provide a breeding ground for mosquitoes.De Rosa said it was important for everyone to do their part to fight Zika because of how unpredictably and quickly it could pop up.“Today it’s Wynwood, tomorrow it could be Orlando,” he said.Helen Branswell reported from Boston.  In Miami’s Ground Zero for Zika, tank tops and shorts still abound Florida confirms it is first state to see locally transmitted Zika virus HealthCDC urges pregnant women to avoid area of Miami where Zika is spreading Frieden described it as a mixed area, with some homes and some industrial properties, some affluent parts, and some areas that are “economically stressed.” That diversity adds to the challenge of trying to control mosquitoes in the area, he said.Attention has focused on Wynwood because two of the first cases work in the area. Testing of other people from the two workplaces as well as the surrounding neighborhood has turned up additional cases, at least six of whom tested positive but reported having no symptoms.The CDC director said despite aggressive efforts by Florida to lower populations of Aedes aegypti mosquitoes — the main species that spreads Zika — the state has seen no reduction in the numbers caught in the traps it sets. That suggests the efforts aren’t working.Frieden offered several explanations, including the possibility that the mosquitoes may have developed resistance to the chemicals being used to control them. Testing to see if that is the case will take at least a week and perhaps three or more.Pregnant women who live in the affected area should routinely take steps to avoid being bitten by mosquitoes, and should practice safe sex to prevent sexual transmission of the virus, the CDC said. It suggested pregnant women without symptoms of Zika who live in or frequently travel to this part of Miami-Dade County should be tested for Zika infection in the first and second trimesters of their pregnancies.And women and men who have traveled to this area should wait at least eight weeks before trying to conceive a child; men who have had symptoms should wait at least six months. [email protected] Helen Branswell About the Authors Reprints Related: A Miami-Dade County mosquito control worker inspects a property in Miami’s Wynwood neighborhood. Joe Raedle/Getty Images Related: General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. So far, Florida has detected 14 people who have contracted the virus in the country’s first Zika outbreak. These people have not traveled to places where the virus is spreading, and it is not believed they were infected through having sex with someone infected with the virus.The area where Zika is believed to be spreading is located north of Miami’s downtown core, known as Wynwood. Andrew Joseph Tags global healthmosquitoesZika Viruslast_img read more

With little known about Zika virus, hospitals scramble to stay ahead

first_img Andrew Joseph “We don’t really know what to expect fully from Zika at this point,” said Dr. Gary Clark, the chief of neurology at Texas Children’s Hospital in Houston. “We’re trying to prepare ourselves for a virus that seems to infect the nervous system quite prominently in multiple ways.”The number of babies born with Zika-related defects in US states remains low: only 16, so far, according to the Centers for Disease Control and Prevention. But 510 pregnant women overall have contracted the virus and many of them have yet to deliver their babies.advertisement Ebola. Zika. Could a rapid-response fund help the US address crises faster? Juliana Duque, a nurse practitioner, uses a fetal heart monitor on a patient who is in her first trimester of pregnancy at the Borinquen Medical Center in Miami. Lynne Sladky/AP Obama administration declares Zika public health emergency in Puerto Rico By Andrew Joseph Aug. 17, 2016 Reprints Tags birth defecthospitalsZika Virus Children who may be affected by Zika in Florida — which has had 60 pregnant women with Zika infections — will enter the state-run Early Steps program, which provides a range of therapy services and will track their health for several years. Even with the program, doctors there are already discussing how to make sure they can keep tabs on what milestones their patients do and don’t hit as the children get older.“If you have a baby and the baby looks completely normal, what’s going to drive you to keep coming back?” said Dr. Ivan Gonzalez, a pediatric infectious disease specialist at the University of Miami. “Our challenge is to try to capture them, keep calling them, reminding them.”The systems hospitals have been putting into place in recent months will guide how they care for Zika patients in future years, but doctors said their experiences with Zika will also inform how they will respond the next time they are called into action against a puzzling disease.“None of us expected a flavivirus would do this, so we’ve been surprised,” said Dr. Kjersti Aagaard, a maternal-fetal medicine specialist at Texas Children’s Hospital, referring to the virus family Zika is in. “But that probably means this isn’t the first time we’re going to be surprised.” Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. [email protected] Related: HealthWith little known about Zika virus, hospitals scramble to stay ahead The threat of Zika virus is reshaping operations at hospitals across the country, as medical teams rush to figure out how best to provide care for pregnant women with the disease and monitor and treat babies with related brain damage.With scientists still trying to better understand the virus — and without any treatments available — hospitals have been forced to adapt to a changing Zika outbreak, particularly in states such as Florida, Texas, and New York that are at risk for local transmission or have seen large numbers of travel-related cases.Hospitals say they have built up their diagnostic tools, started performing more regular ultrasounds for patients, and are keeping closer-than-usual watch on amniotic fluid levels and fetal heart rates. Social workers and physical, speech, and occupational therapists are preparing to work with babies born with Zika-associated defects, should they require their care.advertisement Scientists still don’t know exactly what percentage of pregnant women infected with Zika will give birth to children with defects.That unknown, however, is only one of the mysteries of Zika, which is primarily spread by mosquitoes but can also be transmitted through sex. Scientists are still learning not only about the virus and how it passes from mother to fetus, but also about the ways in which it can affect those who contract it.To bridge the gap, hospital officials say they have assigned doctors to keep up with the growing body of literature and confer with public health agencies. They are also bringing together obstetricians trained in high-risk pregnancies, pediatrician specialists, and virologists and other biomedical researchers.In Miami — the only city in the continental US to see Zika cases spread by local mosquitoes — pediatricians and obstetrician-gynecologists are working hand-in-hand when caring for pregnant women with Zika, said Dr. Christine Curry, an obstetrician-gynecologist at the University of Miami and Jackson Memorial Hospital.They review ultrasound results together, coordinate long-term planning with specialists and the mothers-to-be, and alert doctors on call when to expect a birth from a Zika patient.“When the mom comes for a delivery, the pediatric team has already seen what’s going on,” Curry said. “Usually a pediatrician learns about a kid when they get a page and they come and we hand them a baby.”Doctors say they don’t have good answers yet to the most pressing questions they get from pregnant patients, including if their fetuses are at risk throughout the pregnancy or only certain stages, and how likely their children are to have some sort of developmental problem. Related: Privacy Policy Leave this field empty if you’re human: “That’s a somewhat difficult question to answer right now given what we know about Zika and what we don’t know about Zika,” said Dr. Martha Rac, a maternal-fetal medicine specialist at Texas Children’s Hospital, which has organized a special Zika clinic.Her colleague, Dr. Catherine Eppes, added: “While we can’t tell people exactly what percentage of the time that happens, it’s not automatic.”In addition to microcephaly — a condition in which the brain fails to develop fully and the head remains unusually small — doctors have reported other problems with brain formation, vision, cognition, and joints in babies born to Zika-infected mothers. Even when there are physical deformities, ultrasounds cannot always detect them before a woman gives birth.Doctors also worry about what might happen to children who appear to be fine at birth. In the case of other congenital infections like cytomegalovirus, hearing and vision problems can emerge in apparently healthy children years down the road.“That may just be the tip of the iceberg,” Dr. Jeanne Sheffield, the director of maternal-fetal medicine at Johns Hopkins Hospital, said about microcephaly. Hopkins has also formed a Zika group as Maryland has notched 57 travel-related Zika cases.When Zika first started making headlines at the beginning of the year, and the first flood of calls came from patients who had recently traveled to Latin America, many hospitals were not ready with a coordinated response. As the epidemic spread and more travel-related cases appeared in the United States, teams of doctors geared up to handle a continued demand for information and consultations from patients, especially as the summer mosquito season approached.“We knew we didn’t want to relive what we went through in January,” said Dr. Ashley Roman, director of maternal-fetal medicine at New York University Langone Medical Center, where a multidisciplinary group of experts started meeting weekly in May.The group outlined how the hospital should respond — what updates it should put on its website, for instance, or how many additional nurses it would need — to a variety of scenarios, including the now-real situation of mosquitoes spreading Zika in Florida. Although New York is at a relatively low risk for local mosquito-borne Zika transmission, it has had more travel-related Zika cases — 530 — than any state in the country.The CDC, the American Academy of Pediatrics, and March of Dimes are working on guidelines to care for and track babies born to Zika-infected mothers. But the preparations hospitals are going through now are to ensure they are ready to care for additional infants who may have trouble swallowing, suffer from seizures, and require dedicated care from a host of subspecialists. General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. About the Author Reprints Please enter a valid email address. @DrewQJoseph last_img read more

Up and down the ladder: The latest comings and goings

first_img [email protected] Alex Hogan/STAT Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot?Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the ongoing layoffs. Despite the downsizing, there is movement. Here are some of the latest comings and goings. Recognize anyone?And here is our regular feature in which we highlight a different person each week. This time around, we note that Editas Medicine hired Charles Albright as chief scientific officer. Most recently, he was vice president of genetically defined diseases and genomics at Bristol-Myers Squibb.advertisement Tags EditasjobsValeant Pharmaceuticals Ed Silverman @Pharmalot By Ed Silverman Aug. 26, 2016 Reprintscenter_img BeiGene hired Dr. Amy Peterson as chief medical officer, immuno-oncology;Agios Pharmaceuticals hired Andrew Hirsch as chief financial officer;advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. PharmalotUp and down the ladder: The latest comings and goings Valeant Pharmaceuticals hired Paul Herendeen as executive vice president, finance, and chief financial officer;Valeant Pharmaceuticals says Robert Rosiello remains executive vice president, corporate development and strategy;WAVE Life Sciences hired Keith Regnante as chief financial officer;Zoetis promoted Glenn David to executive vice president and chief financial officer;Arena Pharmaceuticals hired Vincent Aurentz as executive vice president and chief business officer;Apellis Pharmaceuticals hired Dr. Robert Kim as chief medical officer;Acadia Pharmaceuticals hired Todd Young as executive vice president, chief financial officer;Retrophin hired Neil McFarlane as chief operating officer;Anthera Pharmaceuticals hired Dr. William Shanahan as chief medical officer;Primex Pharmaceuticals hired Ernesto Alegria as chief financial officer;ProclaRx hired Doug Martin as chief operating officer;Poseida Therapeutics hired Dr. Matthew Spear as chief medical officer;Poseida Therapeutics hired Ryan Takeya as vice president, technical operations;Poseida Therapeutics hired Glenn Dourado as vice president, business development;LaVoieHealthScience hired Beth Kurth as vice president, investor relations;LaVoieHealthScience hired Benjamin Navon as assistant vice president, public relations;InClinica hired Dr. Thomas Morris as medical director;Ashfield Commercial & Medical Services hired Julia Kelly as vice president of business development;ACell hired Brad Adams as vice president of sales. About the Author Reprintslast_img read more

Drug maker loses appeal of antitrust pay-to-delay case in Europe

first_img Newsletters Sign up for Pharmalot Your daily update on the drug industry. By Ed Silverman Sept. 8, 2016 Reprints Tags antitrustgeneric drugsLundbeck Related: Privacy Policy Former European Commissioner for Competition Joaquin Almunia at a press conference in 2013 when the EU fined drug firm Lundbeck and others 146 million euros for delaying the market entry of generic alternatives to an antidepressant. Yves Logghe/AP Please enter a valid email address. The case has been closely watched because regulators on both sides of the Atlantic have attempted to crack down on such deals. In pay-to-delay agreements, a brand-name drug maker agrees to settle patent litigation by offering cash or possibly something else of value to a generic company that, in turn, agrees to delay the sale of a copycat version.Regulators argue these deals are anticompetitive, force consumers to overpay for medicines, and escalate costs to the overall health care system. In the United States, the Federal Trade Commission estimates such deals cost Americans about $3.5 billion annually. Drug makers counter that the deals are not only legal, but allow lower-cost generic drugs to reach consumers faster than if patent litigation continued.advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] center_img Last April, GlaxoSmithKline appealed a $54.5 million fine that was recently levied by United Kingdom regulators for illegally conspiring with several generic rivals to delay marketing of a lower-cost version of its Paxil antidepressant. The generic manufacturers were also fined a total of about $7 million and are appealing those decisions, as well.Last March, the FTC filed a lawsuit against Endo Pharmaceuticals and three other drug makers for allegedly paying generic rivals to delay launches of copycat versions of two painkillers. This is the first lawsuit, however, in which the agency argues that a deal involving a so-called authorized generic thwarted competition. In such instances, a brand-name drug maker would agree not to sell its own lower-priced version of its medicine, which it might otherwise do to compete with a generic drug maker. @Pharmalot About the Author Reprints A European Commission court upheld an antitrust fine that was imposed three years ago against Lundbeck and four other drug makers for allegedly conspiring to delay the availability of a lower-cost generic version of an antidepressant.The ruling by the General Court of the European Union came in response to an appeal of a 2013 decision that found Lundbeck and the generic drug makers pursued a pay-to-delay deal that violated European Union anticompetition regulations. The European Commission had fined the companies a total of $165 million with Lundbeck ordered to pay the bulk of the fine, or about $105 million.The court ruled that the European Commission had correctly established that the agreements eliminated competitive pressure from the generic companies and restricted competition. Moreover, the court decided that Lundbeck was not able to justify why the agreements would have been needed to protect its intellectual property rights, according to a statement by the European Commission.advertisement Leave this field empty if you’re human: In 2013, however, the US Supreme Court ruled these deals may be subject to antitrust review, but left open to interpretation whether only a cash payment should be considered questionable when a settlement is reached. Since then, branded drug companies have struck far fewer such deals with generic drug makers.For its part, Lundbeck issued a contentious statement saying it “strongly disagrees” with the decision. The agreements with the other companies “did not restrict competition and did not go beyond the protection already offered by society via Lundbeck’s patent rights … Patent settlement agreements are efficiency-enhancing and legitimate when there are bona fide grounds for dispute.” Ed Silverman Drug makers suffer blow in crucial pay-to-delay ruling PharmalotDrug maker loses appeal of antitrust pay-to-delay case in Europe last_img read more

Pap smears may offer early peek at birth defect risk

first_img That’s not the only potential use. The researchers also are examining whether these cells may offer a warning of brewing problems with the placenta.The work is intriguing but still preliminary, said Dr. Ronald Wapner, a prenatal screening specialist at Columbia University.Especially this early in pregnancy, “we have to make sure the cells you get are truly representative of what’s going on in the fetus,” he said, something larger tests could determine.Dr. Catherine Spong of the National Institutes of Health, which helped fund the study, called the research “really nicely done and helpful to the field,” but echoed that caution. The placenta and fetus both originate from the fertilized egg and thus share a genetic profile, but occasionally an abnormality occurs only in the placenta. Spong said as the research continues, it might shed more light on placenta formation.— Lauran Neergaard Aside from better known chromosome abnormalities such as Down syndrome, “there are about 6,000 other genetic disorders which we currently have a hard time to assess noninvasively and as early,” said Wayne State associate professor Sascha Drewlo, co-author of the study in Science Translational Medicine. He calls defects caused by single gene mutations “the biggest gap” in prenatal testing. Severe birth defects are not as lethal as docs once said Related: Today’s main options are invasive tests — amniocentesis and CVS, or chorionic villus sampling — that analyze a sample of amniotic fluid or placenta tissue. They carry a small risk of miscarriage. Amniocentesis typically is performed around 15 weeks and CVS around 10 weeks.advertisement Related: APStock HealthPap smears may offer early peek at birth defect risk About the Author Reprints Associated Press Tags birth defectpap smearwomen’s health A blood test offers a slightly earlier and noninvasive option by analyzing small amounts of fetal DNA that float in a pregnant woman’s bloodstream. Worrisome results are supposed to be verified by an invasive test. Early diagnosis isn’t just about deciding whether to go forward with a pregnancy but can affect prenatal care and what care a baby might need at birth.It turns out that a small number of cells containing DNA of the forming fetus are shed into a mom-to-be’s reproductive tract, where the scrape of a routine Pap can collect them along with the woman’s own cervical cells. They’re called trophoblasts, cells that start the placenta’s growth.The first challenge is to separate those cells from mom’s. The Wayne State team, led by Drewlo and professor D. Randall Armant, calls its method TRIC, for trophoblast retrieval isolation from the cervix.They tested the approach in 20 pregnant women who had Paps between 5 weeks and 19 weeks gestation. The researchers reported on Wednesday that they could extract the trophoblasts and accurately map the DNA inside, a step to identifying genetic disorders. By Associated Press Nov. 2, 2016 Reprints WASHINGTON — A simple Pap smear may one day offer a way to screen for birth defects a little earlier in pregnancy than today’s prenatal tests.Women typically get a Pap during early pregnancy, and Wayne State University researchers report Wednesday that they can capture enough fetal DNA from the cells that test extracts to check for genetic abnormalities.The new study is very small, and much more research is needed. But if the approach eventually pans out, researchers say it might be possible to use as early as five weeks into pregnancy and to detect more disorders noninvasively.advertisement If mom takes acetaminophen during pregnancy, does it affect her child’s behavior? last_img read more

Pharmalittle: Roche profits by tweaking an old drug; specialty pharmacy fined for kickbacks

first_img Ed Silverman [email protected] @Pharmalot By Ed Silverman Aug. 23, 2017 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot Good morning, everyone, and how are you today? We are doing just fine, thank you, despite cloudy skies looming over the Pharmalot campus. After all, the birds are still chirping and a cool breeze is wafting by. Moreover, this marks the middle of the week, which means we have managed to survive this far. Speaking of survival, we will be off for a couple of days, so a colleague will fill in for us. Meanwhile, here are some tidbits. Have a grand day and see you next week …Although studies indicated a Roche (RHO5) cancer drug called Rituxan may suitably treat multiple sclerosis, the company never pursued this option because the patent was due to expire, but the company will still profit substantially, Bloomberg News writes. Why? Instead, Roche tweaked the drug and created Ocrevus, which took years to reach patients and costs $65,000 a year, while Rituxan costs about $8,000 to $10,000 in the U.S. for patients who can get it prescribed for MS. About the Author Reprints GET STARTED Pharmalittle: Roche profits by tweaking an old drug; specialty pharmacy fined for kickbacks center_img Alex Hogan/STAT What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More Tags drug pricingFDApharmaceuticalspharmalittleSTAT+last_img read more

Study examines how far U.S. women must travel to get abortion

first_img ACLU sues to challenge FDA limits on access to abortion pill HealthStudy examines how far U.S. women must travel to get abortion About the Author Reprints NEW YORK — How far do American women need to travel in order to obtain an abortion?A new study, billed as the first of its kind, makes those calculations state-by-state and county-by-county, revealing some striking disparities. In New York, the average distance is about three miles (five kilometers). At the other end of the scale, the average distance in Wyoming is about 168 miles (271 kilometers).The analysis was conducted by researchers with the Guttmacher Institute, a research group that supports abortion rights, using 2014 data on abortion clinic locations and U.S. Census population figures. The findings were published online Tuesday by the journal Lancet Public Health.advertisement A woman walks past Cleveland’s Center for Women’s Health. Many abortion providers in Ohio have either closed or reduced services. Tony Dejak/AP “Increased travel distance means increased costs for transport, overnight stay, lost wages from time off work, and childcare,” she wrote. “For a woman who is economically disadvantaged, having to travel a long distance could put an abortion out of reach, leading her to carry an unwanted pregnancy to term.”Upadhyay suggested that access could be improved if nurse practitioners and certified nurse midwives were allowed to perform abortions without a physician’s supervision. Another step, she wrote, would be for the Food and Drug Administration to lift restrictions on the abortion-inducing drug mifepristone so that women could get it at pharmacies with a prescription. It’s now dispensed only at clinics, hospitals and doctors’ offices.The American Civil Liberties Union filed a lawsuit on Tuesday challenging those FDA restrictions.— David Crary The researchers said the average distance increased between 2011 and 2014 for many women in Texas and Missouri, which imposed restrictions during that period that led to closure of some clinics. At one point recently, there was only one abortion clinic operating in Missouri; there are now two, and abortion-rights advocates are pursuing legal action to expand that number.In a commentary in the journal, Ushma Upadhyay, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, detailed possible repercussions for women facing the long distances. Associated Presscenter_img By Associated Press Oct. 3, 2017 Reprints Nationally, according to the study, half of all women of reproductive age lived within 11 miles (18 kilometers) of an abortion clinic in 2014. However, many women in rural areas lived much farther away; the study said 1 in 5 women nationwide would need to travel at least 43 miles (69 kilometers) to reach the nearest abortion clinic. Related: Related: A provocative abortion clinic opens in the Bible Belt, with no apologies In the states with the longest average distance to travel — Wyoming, North Dakota and South Dakota — at least half of women of reproductive age lived more than 90 miles (145 kilometers) from the nearest clinic providing abortion services. Women in Alaska lived an average of nine miles (about 15 kilometers) from the nearest clinic, but 20 percent of women in that state would have to travel more than 150 miles (240 kilometers).advertisementlast_img read more