By Charles Piller Feb. 8, 2016 Reprints Global summit opens door to controversial gene-editing of human embryos OAKLAND, Calif. — The California Institute of Regenerative Medicine was created in 2004 to fund stem cell research, after the federal government stopped paying for most experiments with human embryos. Now the state agency is considering underwriting another controversial use of embryos that the federal government won’t support — editing their genes.Officials of the state agency, known as CIRM, discussed guidelines and safeguards for this type of research last week at a meeting of an internal committee that evaluates standards for research funding but made no decision about supporting such work. A new gene-editing technology called CRISPR-Cas9 has revolutionized biomedical research and is thought to hold great promise for eventually helping scientists cure hereditary ailments such as Parkinson’s or Huntington’s disease.Laws about embryo research are in flux around the globe, as nations struggle to keep up with quickly changing science. Following the first official government approval of an experiment that would alter human embryo DNA — in the United Kingdom last week — scientists there might soon use the cells during the first two weeks of embryonic development to study genetic factors in infertility.advertisement A donated human embryo seen through a microscope. Sandy Huffaker/Getty Images Related: The California stem cell agency has opened the prospect that state or private groups might take the lead in underwriting germline editing experiments in this country. CIRM spokesman Kevin McCormack said in an interview that his group’s standards panel will assess the issues and report to the full board within about two months. The agency might conclude that current rules are adequate to cover such work if the group chooses to fund it.“The science is evolving so rapidly, even if we don’t make any changes to our (standards), it’s important to look and see if they are good enough, strong enough the way they are,” McCormack said. This kind of research is legal in the United States, but the National Institutes of Health said last year that it won’t fund research involving gene editing of human embryos, eggs, or sperm. Changes to these “germline” genes are inherited by offspring.So far, no researchers have publicly announced experiments to implant altered embryos in a woman’s uterus, let alone use them to create a fully developed baby. But finding the right balance of risks and benefits for genetic changes that can be passed on to future generations remains a central dilemma — and fear — for scientists and the public. In December, an international summit on human gene editing endorsed germline editing research in non-human animals and left open the door to modifying the genomes of early human embryos, eggs, or sperm as long as they’re not used to establish a pregnancy.advertisement CIRM, which already funds research using human embryos, is deciding whether to strengthen rules governing informed consent for embryo donors. Its standards experts are considering, for example, whether CRISPR can ethically be used on embryos obtained before the recent emergence of the gene-editing technology, or if it should be used only on newly donated biomaterials.The agency is considering the use of gene-edited embryos for research that allows them to develop no longer than two weeks, as in the UK experiment.California voters authorized $3 billion in bond sales to create CIRM, in response to a 2001 decision by President George W. Bush to sharply restrict federal funding for embryonic stem cell research. So far, CIRM’s board has committed about $1.9 billion to universities, individual researchers, and companies, although only $1.4 billion has actually been spent.Among state agencies that support stem cell research — including in Texas, Connecticut, New York, and Maryland — only California’s has publicly contemplated human embryo gene editing. The Cancer Prevention and Research Institute of Texas and Bioinnovation Connecticut have not yet considered funding such experiments, their spokespersons said. The Maryland Stem Cell Research Fund has taken no position on this issue, and New York officials could not be reached for comment.Some important private groups that support stem cell research also have moved cautiously. Russ Campbell, a spokesman for the Burroughs Wellcome Fund in Research Triangle Park, N.C., said “this is not an area that we are pursuing or supporting.”Nancy Wexler, president of the New York-based Hereditary Disease Foundation, said her funds are currently committed to other priorities, and she does not anticipate supporting gene-editing of human embryos in the foreseeable future. But she called the recent move in the United Kingdom to promote this work “fantastic.”“Their ability to do that is going to help all of us,” Wexler said, “so I say bravo.” In the LabCalifornia considers funding controversial research: editing genes in human embryos Tags CRISPRgene editinggenetics Related: UK government agency approves editing genes in human embryos
Joe Raedle/Getty Images Replace bad fats with good foods for heart health, study says A journal editorial said public health policies targeting unhealthy eating could potentially help prevent some deaths, while noting that the study isn’t solid proof that “suboptimal” diets were deadly.The study’s recommended amounts, based on US government guidelines, nutrition experts’ advice, and amounts found to be beneficial or harmful in previous research:‘Good’ ingredientsFruits: 3 average-sized fruits dailyVegetables: 2 cups cooked or 4 cups raw vegetables dailyNuts/seeds: 5 1-ounce servings per week — about 20 nuts per servingWhole grains: 2 ½ daily servingsPolyunsaturated fats, found in many vegetable oils: 11 percent of daily caloriesSeafood: about 8 ounces weekly‘Bad’ ingredientsRed meat: 1 serving weekly — 1 medium steak or the equivalentProcessed meat: None recommendedSugary drinks: None recommendedSodium: 2,000 milligrams daily — just under a teaspoon of salt.— Lindsey Tanner Associated Press “Bad” foods or nutrients that were over-eaten include salt and salty foods; processed meats including bacon, bologna, and hot dogs; red meat including steaks and hamburgers; and sugary drinks.The research is based on US government data showing there were about 700,000 deaths in 2012 from heart disease, strokes, and diabetes and on an analysis of national health surveys that asked participants about their eating habits. Most didn’t eat the recommended amounts of the foods studied.advertisement About the Author Reprints HealthBacon, soda, and too few nuts tied to big portion of US deaths The 10 ingredients combined contributed to about 45 percent of those deaths, according to the study.It may sound like a familiar attack on the typical American diet, and the research echoes previous studies on the benefits of heart-healthy eating. But the study goes into more detail on specific foods and their risks or benefits, said lead author Renata Micha, a public health researcher and nutritionist at Tufts University.The results were published Tuesday in the Journal of the American Medical Association.Micha said the 10 foods and nutrients were singled out because of research linking them with the causes of death studied. For example, studies have shown that excess salt can increase blood pressure, putting stress on arteries and the heart. Nuts contain healthy fats that can improve cholesterol levels, while bacon and other processed meats contain saturated fats that can raise levels of unhealthy LDL cholesterol.In the study, too much salt was the biggest problem, linked with nearly 10 percent of the deaths. Overeating processed meats and under-eating nuts and seeds and seafood each were linked with about 8 percent of the deaths.The Food and Drug Administration’s recent voluntary sodium reduction guidelines for makers of processed foods and taxes that some US cities have imposed on sugar-sweetened beverages are steps in the right direction, Micha said. Related: CHICAGO — Gorging on bacon, skimping on nuts? These are among food habits that new research links with deaths from heart disease, strokes, and diabetes.Overeating or not eating enough of the 10 foods and nutrients contributes to nearly half of US deaths from these causes, the study suggests.“Good” foods that were under-eaten include: nuts and seeds; seafood rich in omega-3 fats including salmon and sardines; fruits and vegetables; and whole grains.advertisement Related: Restaurant meals are packed with calories, and we still keep eating them Tags nutrition By Associated Press March 7, 2017 Reprints
Tags pharmaceuticals By Associated Press April 13, 2017 Reprints BusinessPharmaceutical firms ask court to stop their drugs from being used in Arkansas executions A 2015 state law keeps the source of Arkansas’ three lethal injection drugs secret. The Department of Correction, Governor Asa Hutchinson’s office and the attorney general’s office declined to comment on Thursday’s filing by the companies.“We have made repeated as of yet unsuccessful representations in writing and in person to the governor’s office, office of the attorney general and the Department of Corrections to confirm if they are in possession of our product which they intend to use in lethal injections, and if so to return it to us,” Brooke Clarke, a spokeswoman for Hikma, West-Ward’s parent company, said in a statement.Fresenius said it has made similar overtures to Hutchinson and state officials, but hasn’t received any response.Both companies said they’ve put strict controls on their supplies to ensure the drugs aren’t used in capital punishment. Fresenius said its information indicated no sales of its potassium chloride directly or through its authorized distributors to the state’s prison system.“So we can only conclude Arkansas may have acquired this product from an unauthorized seller,” Matt Kuhn, a spokesman for the company, said in a statement. “Pharmaceuticals obtained in this manner are at risk of adulteration or chemical change due to improper handling such as failure to maintain proper temperature levels during storage and transport.”US District Court Judge Kristine Baker is expected to rule Friday in the inmates’ request to halt the executions. The inmates are challenging the compressed execution timetable, as well as the use of midazolam.Arkansas has not executed an inmate since 2005 because of drug shortages and legal challenges. If carried out, the executions would mark the most inmates put to death by a state in such a short period in modern history.— Andrew DeMillo LITTLE ROCK, Ark. — Two pharmaceutical companies asked a federal judge Thursday to prevent Arkansas from using their drugs to execute seven inmates by the end of the month, saying they object to their products being used for capital punishment.Fresenius Kabi USA and West-Ward Pharmaceuticals Corp. were granted permission to file a friend of the court brief in a lawsuit by the inmates aimed at halting the unprecedented execution schedule, set to begin Monday with the lethal injection of two condemned killers.Fresenius Kabi said it appeared that it had manufactured the potassium chloride the state plans to use, while West-Ward had previously been identified by the Associated Press as the likely manufacturer of the state’s supply of midazolam.advertisement About the Author Reprints Associated Press Arkansas inmates Jack Harold Jones Jr., left, and Marcel Williams, are scheduled to be executed later this month. Arkansas Department of Correction via AP “The use of the medicines in lethal injections runs counter to the manufacturers’ mission to save and enhance patients’ lives, and carries with it not only a public-health risk, but also reputational, fiscal, and legal risks,” the companies said in a filing with the court.Arkansas prison officials announced last month they had obtained a new supply of potassium chloride, clearing the way for the executions to begin. The executions are scheduled to occur before Arkansas’ supply of midazolam, a sedative used in flawed executions in other states, expires at the end of April.advertisement
By Julie Rovner — Kaiser Health News May 24, 2017 Reprints Sick people may ‘face extremely high premiums’ under House bill, CBO says Politics What is it? 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. Chip Somodevilla/Getty Images Log In | Learn More 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 — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED Tags CongressinsuranceMedicaidpolicy The Republican overhaul of the federal health law passed by the House this month would result in slightly lower premiums and slightly fewer uninsured Americans than an earlier proposal. But it would leave as many as one-sixth of Americans living in states where older and sicker people might have to pay much more for their health care or be unable to purchase insurance at all, the Congressional Budget Office said Wednesday.In some states, said the report, “less healthy people would face extremely high premiums, despite the additional funding that would be available” in the bill to help offset those increases. GET STARTED Julie Rovner — Kaiser Health News About the Author Reprints What’s included?
What is it? California court says Novartis — and pharma — can be sued over generic drug warnings 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. Tags legalpharmaceuticalsSTAT+ In a blow to the pharmaceutical industry, the California Supreme Court ruled that Novartis (NVS) can be held responsible for injuries blamed on versions of its drugs made by generic manufacturers.The ruling contradicted most decisions in courts elsewhere around the country and, importantly, may create new liability for drug makers, which could be sued in California for failing to warn patients about the risks posed by generic versions of their medicines. Log In | Learn More What’s included? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. 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. [email protected] Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED @Pharmalot By Ed Silverman Dec. 22, 2017 Reprints Pharmalot GET STARTED MARK RALSTON/AFP/Getty Images About the Author Reprints Ed Silverman
@damiangarde National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. 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. By Damian Garde June 19, 2018 Reprints Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED Dominic Romito, who has Duchenne muscular dystrophy, attends a 2016 FDA advisory committee hearing on an experimental treatment that has since been approved. John Boal for The Boston Globe About the Author Reprints Tags biotechnologySTAT+ Sarepta Therapeutics became the toast of biotech on Tuesday after revealing early data on a gene therapy for Duchenne muscular dystrophy that far outstripped Wall Street’s expectations.But Sarepta is hardly alone in the field, and nothing in biotech happens in a vacuum. Here’s a look at what the latest DMD results mean for the company’s competitors. 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’s included? Damian Garde Log In | Learn More GET STARTED What Sarepta’s game-changing data mean for biotech’s other Duchenne players [email protected] Biotech What is it?
One trend that stood out was the drop in drinking milk, which started falling for all Americans after World War II. In recent decades, teens have shifted from milk to soda, then to Gatorade and other sports drinks, and recently to energy drinks like Monster and Red Bull. Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson HealthFewer U.S. teens smoking, doing drugs, and drinking milk One caveat: Most students were not asked about energy drinks so how many kids drink them now isn’t known. A study from a decade ago estimated that nearly a third of kids between the age of 12 and 17 were regularly drinking energy drinks.Kids have shifted from a dairy product rich in calcium and vitamin D to beverages laden with sugar and caffeine, which is likely contributing to the nation’s obesity problem, said Barry Popkin, a University of North Carolina researcher who studies how diets change.“This is not a healthy trend for our long-term health,” he said.For teens, the government recommends 3 cups daily of dairy products — milk, yogurt or cheese.The survey by the Centers for Disease Control and Prevention is conducted every two years. About 15,000 students at 144 high schools were surveyed last year. The surveys are anonymous and voluntary, and there’s no check of medical records or other documents to verify answers.Some of the findings:Not as many teen are having sex, although there wasn’t much change from the 2015 survey results. Last year, about 40 percent said they’d ever had sex, down from 48 percent a decade ago.There was no substantial recent change for cigarette smoking, either. About 9 percent are current smokers, down from more than 27 percent when the survey started in 1991. Ditto alcohol, with 30 percent saying they currently use alcohol, down from 51 percent in 1991.Marijuana use seems to hovering, with about 36 percent of students saying they had ever tried it. But overall, illegal drug use seems to be falling, including for synthetic marijuana, ecstasy, heroin, inhalants, and LSD and other hallucinogenic drugs. For the first time, the survey asked if they had ever abused prescription opioid medications. About 14 percent did.Another first-time question: Have you had a concussion from a sport or physical activity at least once in the previous year? Nationally, 15 percent said they had. The finding may sound high but it’s not far off from what’s been reported by some other researchers, said Michael Collins, who runs a University of Pittsburgh-affiliated sports concussion program.— Mike StobbeThe Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. By Associated Press June 14, 2018 Reprints About the Author Reprints Tags nutritionsexual health NEW YORK — Fewer U.S. teens are smoking, having sex and doing drugs these days. Oh, and they’re drinking less milk, too.Less than one-third of high school students drink a glass of milk a day, according to a large government survey released Thursday. About two decades ago, it was nearly half.Last year’s survey asked about 100 questions on a wide range of health topics, including smoking, drugs, and diet. Researchers compared the results to similar questionnaires going back more than 25 years.advertisement Gerald Herbert/AP Associated Press Trending Now: The survey showed slightly fewer kids are drinking soda and sports drinks now, compared to the last survey in 2015.advertisement