Should biologists stop grouping us by race?

first_img Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. By Sharon Begley Feb. 4, 2016 Reprints Related: Race is a poor proxy for human genetic differences and should no longer be used by researchers, says a paper in the journal Science. APStock High rates of certain cancers plague Asian-Americans Sharon Begley More than a decade after leading geneticists argued that race is not a true biological category, many studies continue to use it, harming scientific understanding and possibly patients, researchers argued in a provocative essay in Science on Thursday.“We thought that after the Human Genome Project, with [its leaders] saying it’s time to move beyond race as a biological marker, we would have done that,” said Michael Yudell, a professor in the Dornsife School of Public Health at Drexel University and coauthor of the Science paper calling on journals and researchers to stop using race as a category in genetics studies. “Yet here we are, and there is evidence things have actually gotten worse in the genomic age.” “Race” means white/Caucasian, black/African, or Asian. That trio is based on easily visible traits, such as skin color and facial features that, biologists once assumed, reflected ancestry and, therefore, shared genes. But these broad categories are both “poorly defined” and “flawed surrogates,” NIH Director Dr. Francis Collins wrote in 2004. About the Author Reprints [email protected] center_img Categorizing someone as “black” can affect medical care, research has shown. Doctors might miss cystic fibrosis in “black” patients because it is considered a “white” disease, a 2015 study suggested. Similarly, because blood disorders called thalassemias are considered a Mediterranean/white disease and sickle-cell anemia a black disease, they are sometimes misdiagnosed when they strike the “wrong” racial group, Yudell and his colleagues wrote.advertisement Using race as a category has other harmful consequences. The higher rates of hypertension and breast cancer deaths among African Americans, for instance, likely reflect socioeconomic, environmental, and other nongenetic factors. “So many health disparities are not about race but are about social conditions,” such as education, and access to health care, Yudell told STAT, so analyzing health data through the prism of race can blind scientists to factors that contribute more to those disparities.The reason scientists still use race as a way to group people — asking, for instance, which genetic variants are more common in this or that race — is that many still consider the concept useful if imperfect, said geneticist Neil Risch of the University of California, San Francisco, and president of the American Society of Human Genetics. There are so many racial injustices and more egregious misuses of genetics, he said in an interview, that “there are much bigger fish to fry” than scrubbing race as a biological category. For instance, the genetics society got its first-ever black board member, Charles Rotimi of the National Institutes of Health, only last year.advertisement Related: Tags geneticsHealth Disparitiesraceresearch In the LabShould biologists stop grouping us by race? “Surrogate” means that “black,” for instance, is used to stand for “having ancestral roots in Africa.” But the genomes of African-Americans are, on average, 24 percent European (that is, one-quarter of their genetic variants originated in populations in Europe). The average European-American genome is 4 percent African, a 2014 study found. So while race provides a clue to ancestral origins and, therefore, genetic inheritance, it is an imprecise clue because many people have ancestors from many regions of the world: a “black” American often has important “white” gene variants, including ones linked to disease.Scientists including Collins and his rival in the Human Genome Project, Craig Venter, urged biologists more than a decade ago to move away from the Big Three racial categories and substitute something more accurate. Yet many genetic studies still use race.Yudell and his colleagues, including an anthropologist and a sociologist, are asking the National Academy of Sciences to convene a panel to recommend ways to categorize people more precisely than by race. Research journals, they say, should discourage use of racial categories in studies that analyze genetic and other biological or medical data, substituting more precise groupings such as ancestry or population — Kurdish or Basque, for example, or Filipino, or Japanese, or Ito.“It’s time to move on” from race, Yudell said.A fair-size contingent of biologists disagree. They agree that race is imperfect, but say it is a useful way to group people. In a 2015 study, for instance, UCSF’s Risch and his colleagues found that 17 percent of 100,000 people had genomes indicating ancestry from more than one continent. They self-identified as belonging to any of 23 ancestral groups (for example, Afro-Caribbean, white European American, Ashkenazi Jewish) like those the Science essay calls for using. But when those 23 groupings were collapsed into seven, basically by continent, they tracked genetic ancestry fairly well.Seven is more than three, however (the extra four groupings came from breaking Asians and Caucasians into finer classifications, such as East Asian and Pacific Islander). Yudell is waiting to hear whether the National Academy of Sciences will study the use of race, but even scientists who think race is a reasonable proxy for genetic ancestry have recognized that three is not enough. How medical schools can affirm that black lives matter @sxbegle last_img read more

Letter from Washington: Drug makers peer out from the bunker

first_img “Of course, as we know, science doesn’t just happen. Our industry makes it happen.” Privacy Policy Kenneth Frazier is the CEO of Merck and chairman of PhRMA’s board. Mark Lennihan/AP ‘Getting away with murder.’ On the campaign trail, Big Pharma takes a beating Please enter a valid email address. WASHINGTON — Drug industry executives don’t get it: They’re not supposed to be the bad guys.That was the feeling that seemed to permeate the annual meeting of the Pharmaceutical Research and Manufacturers of America, which gathered here this week amid withering scrutiny from politicians and the public.The blame was spread around. Political candidates don’t understand how drug prices work. Neither does the public. The media isn’t helping, of course, focusing on outlandish characters like Martin Shkreli who don’t represent the bulk of a $300 billion industry.advertisement Kenneth Frazier, CEO of Merck There was a lot of that going around.Stephen Ubl, PhRMA’s new president and CEO, was even more blunt. He alluded to a tweet from Hillary Clinton, announcing a forthcoming plan to combat price-gouging for medications. Some analysts blamed the tweet for a $132 billion loss in biotech investment.Ubl was indignant.“As we all know, the debate is largely myopic and misinformed,” he said. “The debate also ignores the value our products bring to patients, the health care system and the broader economy.”“You wouldn’t know it from the headlines,” Ubl added. “The value is barely a footnote in these stories.”Industry reps will tell you that the issues they’re confronting right now, access and pricing, aren’t new. Drug costs are actually relatively stable as a share of national health care spending. Have you seen the latest breakthroughs, a cure for hepatitis C and revolutionary immunotherapies for cancer?They aren’t necessarily wrong about that. But nevertheless, the American public’s opinion of the pharmaceutical industry is dimming. Presidential candidates, from Bernie Sanders to Donald Trump, won’t hesitate to attack the industry and what they describe as its undue influence in Washington.And that might be why those gathered at the Wardman Marriott this week sounded so befuddled. Nobody else seems to get it.“Nobody in the American public understands it,” Andy Slavitt, a top Obama administration health official, said flatly of drug pricing. Related: “The headlines don’t tell the full story,” Kenneth Frazier, Merck CEO and chair of PhRMA’s board, said to open the meeting Wednesday.The drug industry’s reputation “has been tarnished by bad actors,” Frazier said, and become “an easy political target.”advertisement Under siege over prices, drug makers ready their counterpunch They talk on the one hand about being “on the cusp of a golden era of discovery,” as Ubl put it. At the same time, he warned minutes later, “no one should doubt our resolve to fight price controls in whatever shape they may take.”It’s a carrot and a stick. The drug industry says it is willing to defend its value and propose policies that it says would reward it. Medicine is on the edge of exciting new discoveries for cancer and Alzheimer’s disease.But woe to the world if anybody gets in the way.“We stand on the cusp of an amazing era of new medicines,” said George Scangos, the Biogen CEO and incoming chair of PhRMA’s board, to conclude the meeting. But without an industry to develop them, let’s not forget, “very few medicines will reach patients.” Related: BusinessLetter from Washington: Drug makers peer out from the bunker Leave this field empty if you’re human: Who can blame them? Pharmacy-benefit managers. Out-of-pocket caps. Market exclusivity and inter partes review. There is a lot going on behind the scenes — from the list price that often drives headlines to the price that everyday people see when they’re checking out at the pharmacy counter.Pharma’s great puzzle, one it still hasn’t quite figured out how to crack, is how to make it digestible. Frazier, in his opening speech, acknowledged the need “to do a better job of communicating our value” to the media, policymakers, and patients.So they’re putting more and more energy into telling the feel-good stories of new treatments that are saving and improving lives. This week’s conference was peppered with posters and interludes touting therapies that are helping people with HIV and cancer.Frazier pointed out that former President Jimmy Carter is now cancer-free thanks to an immunotherapy “that didn’t exist just two years ago.”“Of course, as we know, science doesn’t just happen,” he said. “Our industry makes it happen.”That is the tightrope that PhRMA is trying to walk. As public opinion sours, drug makers want to appear willing to engage, to acknowledge people’s struggles, and work toward a solution. But they are also confident in their value as an industry and often sound baffled that others don’t see it. It’s not just the amorphous US public either. Talking about patent policy, a topic of great importance to the drug industry because it protects their investments in research, Senator Chris Coons of Delaware said: “It is a relatively obscure field for most in Congress.”Therefore, he added somewhat ominously, “It is easy to mislead staff and members.”The magnifying glass of the presidential campaign is making the current debate a little more urgent for the industry, it seems. After listing examples of presidential candidates proposing policies that already exist, one attendee was incredulous.“It’s policy that’s already in place that candidates aren’t familiar with,” she said, “and they’re just coming out with things people want to hear.” By Dylan Scott March 10, 2016 Reprints Tags drug developmentlobbying Newsletters Sign up for Pharmalot Your daily update on the drug industry.last_img read more

Watch: This operating room changed medical history

first_img The Ether Dome Through The YearsVolume 0%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Link EmbedCopiedLive00:0001:0701:07  Billions without access to safe, reliable surgery Ether changed surgery forever. It has since been replaced with safer alternatives, but its place in history is secure: The operating theater at Mass. General was designated a National Historic Site in 1965.Today, visitors can explore the unique architecture of the hospital’s Ether Dome, as well as a small collection of artifacts, including an oil painting of the famous first surgery. The dome also houses Padihershef, an Egyptian mummy donated to the hospital in 1823.Take a 360 degree tour of the Ether Dome: Tags anesthesiaMassachusetts General Hospitalsurgery Don’t MissWATCH: This operating room changed medical history By Dominic Smith April 11, 2016 Reprintscenter_img Related: STAT takes you on a tour of The Ether Dome through the years. Dom Smith/STAT We have come to think of surgery as relatively safe and reliable, but this was not always the case. Surgery was once a brutal ordeal to be undertaken only in extreme circumstances; surgeons used cotton wool to muffle the screams as patients sat upright, bound by leather to elevated chairs.The only way to curb the pain was by use of alcohol and opiates, though many surgeons believed pain was vital for keeping the patient alive. It was a traumatic experience for doctor and patient alike.It is hardly surprising, then, that word spread rapidly around the world when, in 1846, renowned surgeon Dr. John Warren staged a public demonstration at Massachusetts General Hospital of a new drug, ether. He and a colleague anesthetized patient Edward Abbott and removed a tumor from his neck.advertisement Reportedly, Abbott awoke and said, “Feels as if my neck’s been scratched.”Warren, who was also the first dean of Harvard Medical School, turned triumphantly to the audience and proclaimed: “Gentlemen, this is no humbug!”advertisementlast_img read more

Hillary Clinton remains ‘healthy and fit to serve,’ her doctor says in new letter

first_img Privacy Policy Leave this field empty if you’re human: Schaffner also noted that Clinton’s low blood pressure makes her more likely to get woozy in certain circumstances — such as when she’s dehydrated — but “from a cardiac point of view, that’s a helluva good blood pressure.”Clinton, 68, recently underwent a complete physical exam, which found her blood pressure was 100/70, her heart rate was 70 and her cholesterol was 189, Bardack said. Those numbers were virtually unchanged from the letter that the Clinton campaign released last July.Clinton also continues to take medication for her hypothyroidism and an anticoagulant as a precaution to avoid blood clots, which Clinton has had several times in her life, Bardack said.Bardack also disclosed that Clinton developed a sinus and ear infection in January, with increased fluid in her left ear. An ear tube was used to address her symptoms and a follow-up exam in March 2016 showed no abnormalities, Bardack said.The new disclosure follows Clinton’s recent bout with pneumonia and her faintness at the 9/11 memorial service, which was captured on video and led to intense media coverage of her health. Clinton’s campaign said she promptly recovered, though she took a few days to rest at home on the advice of her doctor. Aside from an ongoing bout of pneumonia, Hillary Clinton is in good physical and mental condition, her doctor said in a new letter released Wednesday.Clinton has a mild case of non-contagious bacterial pneumonia, Dr. Lisa Bardack said, and she is taking a 10-day regimen of Levaquin to address it.“She is recovering well with antibiotics and rest,” Bardack said. “She continues to remain healthy and fit to serve as president of the United States.”advertisement Please enter a valid email address. Two days later, Clinton became dehydrated and overheated at a 9/11 memorial service, the episode that eventually brought the diagnosis to public attention. Bardack examined Clinton again after she returned home and advised the candidate to stay home for a few days to rest.Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University, said the background health information provided “all seems very unremarkable” but that the new release provided “a much more thorough discussion of her recent illness.”He said the location of Clinton’s pneumonia, on the right side of her chest, was a common location and noted that Clinton has received the two pneumococcal vaccines that are recommended for people 65 and older. The bacteria the vaccines protect against can cause pneumonia, although it’s not clear what caused Clinton’s pneumonia. A conspiracy-free, facts-only guide to the health of Clinton and Trump Hillary Clinton’s doctor remains out of the spotlight as attention to candidate health escalates Related: Justin Sullivan/Getty Imagescenter_img Related: Bardack recounted the last few weeks that led up to the disclosure on Sunday of Clinton’s pneumonia diagnosis, which has attracted extensive news coverage.The doctor examined Clinton on Sept. 2, she said, after the candidate reported a low-grade fever, congestion, and fatigue. Over the next few days, Clinton’s congestion worsened and she developed a cough. Bardack saw Clinton again on Sept. 9, and a CT scan revealed small right middle-lobe pneumonia.advertisement PoliticsHillary Clinton remains ‘healthy and fit to serve,’ her doctor says in new letter By Dylan Scott Sept. 14, 2016 Reprints Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. Tags Hillary ClintonpolicyPresidential campaign Clinton’s physician said last year that she was “in excellent physical condition” in a letter that included about the same amount of details as reports released by Barack Obama and Mitt Romney during their campaigns. It recounted her history with blood clots, for which she still takes medication as a precaution, and her 2012 concussion, from which the doctor said Clinton had fully recovered. That was also the result of Clinton being sick (with a stomach virus) and getting dehydrated. She then fainted and suffered a concussion.But some figures on the conservative fringe have been pushing the story much further, alleging that Clinton might suffer from more serious health conditions than she has disclosed. There has thus far been no evidence that Clinton has any other underlying health problems. Her doctor has pointedly said that she had no other issues aside from hypothyroidism, for which she also takes medication, and seasonal allergies.Andrew Joseph contributed to this report.last_img read more

Rich countries are more anxious than poorer countries

first_img General Assignment Reporter Kate covers biotech startups and the venture capital firms that back them. [email protected] APStock Quick TakeRich countries are more anxious than poorer countries Richer countries have higher rates of anxiety in their population than poorer countries and — in a finding that surprised even the researchers — that anxiety also interfered more with daily activities and responsibilities.Specifically, there was a higher proportion of people in higher-income countries with generalized anxiety disorder, or GAD — defined as excessive and uncontrollable worry that affects a person’s life — and with severe GAD. The researchers, who are members of the WHO World Mental Health Survey Consortium, published their findings in JAMA Psychiatry on Wednesday.For example, Australia and New Zealand, both identified as high-income countries, had the highest lifetime prevalence rates — 8 percent and 7.9 percent, respectively. Nigeria (0.1 percent) and Shenzhen, China (0.2 percent), had the lowest rates reported; both were categorized as low-income areas.advertisement Kate Sheridan But no one has actually reported about this much data in this many countries since the diagnostic criteria for GAD changed in 2013. (The consortium also published results in 2004 and 2009 about prevalence and treatment rates of some mental illnesses in over a dozen countries.)The nitty-gritty:Researchers analyzed data from interviews with nearly 150,000 people in 26 countries over 12 years to determine if people had GAD as defined in psychology’s key reference text, the Diagnostic and Statistical Manual of Mental Disorders. People with GAD were also asked if it had interfered with their everyday responsibilities and activities.Countries got sorted into low-income, middle-income, and high-income categories based on gross national income per capita — a measurement based in part on gross domestic product. (It’s the same criteria the World Bank uses.)The American Psychiatric Association published the latest version of the DSM in 2013 — after the surveys were administered — so researchers had to take the modified criteria into account when they analyzed their data. One of the biggest changes: DSM-IV didn’t allow practitioners to diagnose people with GAD if symptoms only happened when patients also had symptoms of a mood disorder like bipolar disorder or depression. The DSM-5 does. 5 lessons from my decades of struggle with depression and anxiety About the Author Reprints @sheridan_kate Why it matters:“We’re trying to make the case with these data that this is a disorder that is reasonably prevalent and associated with a substantial role impairment, and we need to be paying attention to it in clinical settings,” said lead author Ayelet Meron Ruscio, a psychology professor at the University of Pennsylvania. The data could also serve as a first step to understanding how GAD presents or develops in different countries, which would be useful for people developing prevention and treatment programs. Related: But keep in mind:This study may actually underestimate the prevalence of GAD. The interview tools they used tend to produce conservative estimates, the authors stated. The response rates to the surveys also varied widely by country.There is also one obvious limitation to comparing prevalence rates across countries: Social and cultural conventions influence how likely someone is to self-report symptoms of anxiety to an interviewer and how likely those symptoms are to be recognized as clinically significant. GAD has been defined primarily on how it presents in people living in countries like the United States, Ruscio noted. (Some studies have shown that anxiety may present with more physical symptoms in non-Western countries.)Associations between a country’s income and GAD prevalence doesn’t meant that prevalence differences within a country should be ignored. The association between lower income and higher rates of anxiety disorders within a country has been well-established, said Ruscio. These results don’t change that.Several of the authors disclosed grants and honoraria from pharmaceutical companies; one author co-owns a health care market research firm.What they’re saying:Researchers who had not worked on the paper could not be reached for comment Tuesday evening or Wednesday morning. (Some of the researchers contacted lived in areas affected by winter storm Stella, the blizzard that hit the East Coast on Tuesday.)But this paper builds on lots of other work done by the WHO’s Mental Health Survey Initiative. The initiative doesn’t just study anxiety — researchers have also collected data about substance abuse, mood, and behavioral disorders. Another study from the group that also found lower rates of mental disorders in some lower-income countries had chalked up the findings in part to methodological issues.The bottom line:On average, GAD is more prevalent in higher-income countries, but that doesn’t necessarily mean there are fewer anxious people in lower-income countries. Many different factors, including diagnostic criteria and social conventions, may be responsible.Lifetime prevalence of DSM-5 anxiety:All locations: 3.7 percentNigeria 0.1 percentShenzhen, China 0.2 percentPoland 0.9 percentBeijing, China and Shanghai, China 1.0 percentRomania 1.0 percentPeru 1.1 percentMexico 1.1 percentGermany 1.5 percentColombia 1.9 percentSpain 1.9 percentItaly 2.1 percentBulgaria 2.3 percentLebanon 2.3 percentJapan 2.6 percentBelgium 2.8 percentUkraine 3.3 percentThe Netherlands 3.6 percentSouth Africa 3.6 percentMedellín, Colombia 3.8 percentIsrael 4.4 percentIraq 5.0 percentBrazil 5.1 percentPortugal 6.1 percentFrance 6.2 percentNorthern Ireland 6.4 percentMurcia, Spain 7.0 percentUnited States 7.8 percentNew Zealand 7.9 percentAustralia 8.0 percent By Kate Sheridan March 15, 2017 Reprints Please enter a valid email address. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Privacy Policy Leave this field empty if you’re human: Researchers thought prevalence rates might be different in lower-income countries because of the relative political or economic instability. These circumstances could have directly contributed to higher rates — or indirectly led to lower rates, since people might not report “excessive” anxiety because their worries were justified by the issues they faced.advertisement Tags Health Disparitiesmental healthresearchlast_img read more

Watch: Scientists develop a phone app that can track and analyze sperm

first_img“For semen analysis, measuring sperm concentration and motility are the most critical parameters that clinicians actually look for,” said Hadi Shafiee, senior author of the study and a principal investigator in the Division of Engineering in Medicine and Renal Division of Medicine at Brigham and Women’s Hospital.This new technology is described in a paper published Wednesday in Science Translational Medicine.advertisement A father’s sperm could predict whether his child will be obese Why it matters:The idea to develop this technology came 2 1/2 years ago after Shafiee talked to several urologists. After a vasectomy, men had to return to the hospital a couple of times after the procedure to test their semen. The urologists told Shafiee that it would be useful if patients could test their semen at home.“Post-vasectomy compliance testing is actually very poor,” Shafiee said. Computer-assisted semen analysis is expensive and time-consuming, while manually analyzing semen is subjective, and results can be inconsistent between labs.Apart from post-vasectomy testing, Shafiee sees numerous other applications of this technology.Couples trying to conceive don’t need to visit a clinic and can instead use the kit at home, especially if they live in an area where infertility is stigmatized. People with smartphones in developing countries could use it if they can’t travel to a clinic or lack the resources to do so. Animal breeders could also adapt the kit to regularly test animal semen.The nitty-gritty:The phone case contains two lenses pulled from CD and DVD drives, and an LED light to illuminate the sample. The case cost $3.59 to make.To load the sperm into the case, the researchers designed a manually operated sampler that cost them $0.86 to make. Sperm goes up a detachable tube into a disposable microchip. Related: About the Author Reprints Hyacinth Empinado Checking male fertility, with the phone in your pocketVolume 0%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Link EmbedCopiedLive00:0001:2401:24  Researchers from Harvard Medical School and Brigham and Women’s Hospital have developed an inexpensive and discrete way of screening for male infertility. Hyacinth Empinado/STAT In the LabWatch: Scientists develop a phone app that can track and analyze sperm NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. By Hyacinth Empinado March 22, 2017 Reprints The technology does not require any training to use. During the study, the researchers had trained and untrained people use the app and accessories, and they did not see any difference between the results.Once the microchip is loaded, the Android-based app records one-second-long videos and uses each video frame to track sperm. It can deliver results in less than five seconds with over 98 percent accuracy.The researchers compared the results of the app against those obtained through standard laboratory analysis. Out of the 350 semen samples, lab tests classified 307 of them as abnormal using standards set by the World Health Organization. The app was able to detect 303 of the abnormal samples. Samples were abnormal if they had less than 15 million sperm per milliliter and less than 40 percent of the sperm in the sample were swimming.But keep in mind:The app and the phone accessories won’t be available anytime soon. The researchers are still planning on doing more tests and seeking approval from the Food and Drug Administration. Shafiee is creating a startup to get the product on the shelves, and he envisions that the entire kit would cost around $50.The app also has its limitations. It has trouble accurately identifying sperm concentration in samples that have more than 100 million sperm per milliliter.The app also has difficulty differentiating between sperm and debris that has a similar size to the sperm head.center_img Sperm test 2.0: New diagnostics aim to better understand male infertility Please enter a valid email address. Tags fertilityresearch [email protected] Smartphones can now be used to track and analyze sperm.Researchers from Harvard Medical School and Brigham and Women’s Hospital have developed an inexpensive and discreet way of screening for male infertility by creating an app that could be used with a few phone accessories.Using the phone’s camera and a specially designed 3-D printed phone case that can magnify the sperm, the app can measure the amount of sperm in semen and how many of them are actually swimming.advertisement Related: Multimedia Producer Hyacinth creates videos and animations for STAT and is the senior producer of “The Readout LOUD” podcast. Leave this field empty if you’re human: What they’re saying:“The device has many advantages: simple, fast, accurate and inexpensive,” Ashok Agarwal, director of the Clinical Andrology Laboratory and Sperm Bank at Cleveland Clinic, said in an email. “I believe that the application of this device for post-vasectomy sperm check could be a game changer.”But he said that the biggest limitation of the technology was that it could not detect problems in sperm morphology — the size and shape of the sperm. Defects in the sperm’s head or tail could cause difficulties reaching or penetrating the egg.“This is important because it is well-established that sperm concentration and sperm motility are less important when it comes to predicting the fertility in assisted reproductive technology,” said Agarwal, who wasn’t involved with the study.The bottom line:Smartphone-based methods to measure the amount of sperm and its motility could, in the future, lower the cost and stigma to regularly testing male fertility, but you shouldn’t expect to see it in the app store just yet. @sayhitohyacinth Privacy Policylast_img read more

Vietnam battles dengue outbreaks with 42 percent more cases

first_imgHealthVietnam battles dengue outbreaks with 42 percent more cases Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Dr. Vu Minh Dien examines dengue patient Tran Thi Xuyen at the National Hospital of Tropical Diseases in Hanoi, Vietnam. Tran Van Minh/AP Trending Now: Dien said some 300 dengue patients were being treated, stretching the hospital’s resources, including longer working hours without weekend leaves.advertisement About the Author Reprints HANOI, Vietnam — Vietnam has been battling raging dengue fever outbreaks with more than 10,000 new infections reported over the past week stretching its medical system.The number of admitted patients represents a 42 percent increase over the same period last year along with seven more deaths, the Ministry of Health said Friday. A total of 90,626 people have been infected, of whom 76,848 have been hospitalized and 24 have died.The ministry attributed the rise of dengue outbreaks to higher temperature, more rains, and rapid urbanization that promote the breeding of virus-carrying mosquitoes.advertisement By Associated Press Aug. 18, 2017 Reprints Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine.center_img Leave this field empty if you’re human: Hanoi and the southern commercial hub of Ho Chi Minh City are the hardest hit.The government on Thursday urged residents to actively engage in killing mosquitoes and mosquito larvae, particularly at construction sites and housing for workers.“The joint efforts by the people as well as our political system in searching and eliminating mosquito larvae, emptying water containers, which are fertile for larvae to breed, and spraying chemicals to kill mosquitoes are key factors to curb dengue fever,” Dien said.— Tran Van Minh Please enter a valid email address. Associated Press Tran Thi Xuyen, a fruit and vegetable seller in a small market in Son La province, said she did not know how she contracted dengue fever, which also infected her fellow saleswoman.“I took antibiotics prescribed by the local district hospital for four days, but the fever did not go away and I admitted myself to this hospital where doctors said I had dengue fever,” she said from her hospital bed.There is no cure for any of the four strains of the mosquito-borne virus that causes high fever, exhaustion and in some cases a vicious skin rash. Patients most at risk of dying are the elderly, children or those with other medical complications. Dr. Vu Minh Dien of the National Hospital of Tropical Diseases in Hanoi, where the most severe cases were being treated, said that 800-1,000 people have been checking in daily complaining of fever. That compares to only several cases that reported to the hospital in June and July last year, he said. Privacy Policy Tags infectious diseasepublic healthlast_img read more

Families sending kids to college get mixed messages on meningitis B vaccine

first_img Four years ago, when meningitis B, an extremely rare but potentially lethal form of the infection, sickened a small number of college students at Princeton and the University of California-Santa Barbara, there was no vaccine against the disease sold in the U.S. Despite its availability abroad, it had never been licensed in the country due to its limited marketability.Scientific evidence supporting an absolute need to immunize against meningitis B still falls short. The risk of contracting it is smaller than that of being involved in a car crash. 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. By Shefali Luthra — Kaiser Health News Sept. 8, 2017 Reprints What’s included? Families sending kids to college get mixed messages on meningitis B vaccine Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED GET STARTED 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.center_img Pharma Shefali Luthra — Kaiser Health News Log In | Learn More Damian Dovarganes/AP About the Author Reprints What is it?last_img read more

The fantastic voyage of a bag of cells shipped west to be trained in the art of cancer killing

first_img Tags biotechnologycancerdrug developmentdrug pricinghospitalspatientsphysicians Only about 8 percent of patients with refractory DLBCL respond to yet more chemo. The rest are sent home with instructions on how to manage pain in their waning days. At the median, patients survive for about seven months.At 51, Matthews is fit, active, and unfailingly positive. Yet his doctors explained that his immune cells no longer knew how to fight. They had become tolerant to his lymphoma, allowing cancer cells to flourish unchecked.A clinical trial offered some hope that that the cells could be retrained — could get back their fighting spirit, the medical team at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital told Matthews. In an earlier clinical trial of the CAR-T treatment, roughly one-third of patients with the same stubborn disease saw their cancer disappear after three months, while more than three quarters had at least a partial response to therapy.There were risks. A handful of patients had died in previous studies, overcome by a rapturous fever or killed by the treatment’s toxic effects on the brain. And the therapy itself leaned toward science fiction. The long-term effects are not yet known. “You know their life is in your hands.” Dave Matthews, cancer patient Damian Garde By Damian Garde Oct. 27, 2017 Reprints BOSTON — Dave Matthews describes his cancer as “the monster inside me.” It’s the one thing he cannot control.And over the summer, it began to look as though the monster would prevail.After six months of treatment and a grueling eight rounds of chemotherapy, Matthews’s lymphoma had stopped responding to medicine’s best efforts. For most patients, that’s the end of the line. Matthews’s doctors, however, gave him one more option.advertisement Matthews, for his part, passed the time at home, trying to go about life as normally as possible while scientists “did their magic” with his T cells.“In a way it’s kind of comforting” knowing a multibillion-dollar pharmaceutical company is working to cure your personal cancer, he said. “But maybe a little nerve-wracking, too.”About two weeks after apheresis, he got a call: His T cells were ready for battle and en route back to the hospital. On Sept. 18, he would get them back. But first, he’d have to prepare.Priming the body for an invasionBefore defrosting Matthews’s CAR-T dose, doctors administered three consecutive days of chemo. This time, the target wasn’t his cancer; they were trying to kill off his remaining T cells. The process, often referred to as priming, is meant to clear the way for the CAR-Ts and allow them to flow freely in the patient’s blood to maximize their cancer killing effect.The following Monday, Matthews checked back into the hospital. And the next day, in a 15-minute procedure he called “uneventful,” he was reunited with his well-traveled T cells.Then he waited.The first day was no sweat, Matthews said, beyond a bit of fatigue. On day three, with Diane at his side, he clocked four miles wending through the hospital hallways.“But then started the fever,” Matthews said. It would involve siphoning out his white blood cells and sending them on a cross-country expedition so genetic engineers in a factory outside Los Angeles could train them in the ways of cancer killing. The cells would be rewired and nurtured in an incubator, then frozen and shipped to Boston to be dripped back into his veins.The experimental process would take a month and would require the combined efforts of more than 150 doctors, nurses, scientists, and couriers. Their work on Matthews and other patients would eventually validate the paradigm-shifting gene therapy, known as CAR-T. The successful clinical trials would lead to regulatory approval of two CAR-T treatments for rare and deadly blood cancers.advertisement Dave Matthews But Matthews didn’t know all that when he agreed to send his cells on a last-chance odyssey.All he knew was that the monster was winning.His cancer, an aggressive subtype called diffuse large B-cell lymphoma, or DLBCL, was what doctors call refractory. “We thought chemo and cancer was bad,” said Matthews, who runs a small business that supplies fire departments, “but when you hear the word ‘refractory,’ you pretty much know what that means.” “We thought chemo and cancer was bad. But when you hear the word ‘refractory,’ you pretty much know what that means.” The most common reaction to CAR-T therapy is called cytokine release syndrome, which results from the immune system kicking into overdrive. In a way, it’s more a feature than a bug, as feverish symptoms mean CAR-T is doing its job.But it can be severe and even deadly, said Nikiforow, the Dana-Farber oncologist, with roughly one-third of CAR-T patients ending up in intensive care as a result.Matthews’s fever put a stop to all the walking, but it never got too severe, and doctors eventually tamped it down with some “fancy footwork,” Nikiforow said. A few neurological side effects ensued, leaving Matthews sometimes struggling to find the right words to fit a sentence and experiencing intermittent “loopiness,” he said. And for about 24 hours, his salivary glands swelled up, distending his jawline and stoking a headache.Each effect eventually subsided, and Matthews went home about a week later, anticipating an answer to the only question that had come to matter: Did it work? Tim Moore, executive vice president at Kite A technician at Kite Pharma transfers materials used in CAR-T to another portion of the factory using a pass-through window. Kite/Gilead Newsletters Sign up for Cancer Briefing A weekly look at the latest in cancer research, treatment, and patient care. CAR-T cancer therapy is potent, but can be lethal. New research helps explain why Once Matthews’s cells arrived at Kite’s facility, workers tested them to ensure they had not been thawed or frozen too deeply en route. They then purified the contents of the bag, isolating the T cells from any stray plasma or red blood cells that may have snuck in back in Boston. From there, the cells went into an incubator to grow.Then the genetic engineering began.A dose of CAR-T therapy is frozen and prepared for shipping so it can be infused into the patient. Kite/GileadGrowing an army of killer cellsIn a process called transduction, Kite used a harmless virus to inject a gene into Matthews’s T cells. The gene wires the cells to seek out a protein called CD19, which is present on the surface of lymphoma cells.The goal: teach the T cells, which had been so complacent earlier in the summer, to swarm Matthews’s cancer cells — and kill them.But a few killer cells couldn’t tame the monster alone. Matthews would need an army of them.So Kite’s team put the edited cells into an incubator and left them alone to replicate for a week, until there were millions of them. That’s what it takes to make an effective dose of CAR-T.Another week passed: Kite repeatedly tested the cells to make sure the treatment was sterile, potent, and ready to ship.Only then did the couriers return to send the CAR-T army back to Boston. Related: @damiangarde Please enter a valid email address. Related: BiotechThe fantastic voyage of a bag of cells shipped west to be trained in the art of cancer killing There’s only one approved CAR-T, but companies are ready to capitalize on it It was all detailed in a weighty ream of data that Matthews and his wife, Diane, pored over in their home in a Connecticut town about 90 minutes south of Boston.“Why wait?” had become something of a mantra for the couple. Together for three years, they’d considered putting off a wedding until all of their six children — three apiece from previous marriages — had finished school. Then Matthews was diagnosed. “Why wait?” they thought, and had married in June, six months after he found he had cancer.Now, mindful of that word “refractory” and all its implications, “Why wait?” seemed just as relevant to the trial.“I mean, for us, it was a no-brainer,” Matthews said.Matthews gets re-infused with his own genetically engineered T cells at the Dana-Farber Cancer Institute. Screen capture via Dana-Farber/Brigham and Women’s Cancer CenterA small bag of worn-out T cellsDave Matthews’s CAR-T journey started in late August, in a small room at the Brigham’s blood donor center.Doctors stuck him with a pair of IVs, one in each arm, with what’s called an apheresis machine in the middle. Over the next five hours, his entire blood supply passed twice through the machine, which filtered out T cells, a type of white blood cells.The result: a bag the size of a packet of M&Ms, packed with Matthews’s T cells. That bag was sent immediately to a lab at Dana-Farber, where a team led by cell transplant expert Dr. Sarah Nikiforow repeatedly tested the cells to ensure their purity. Then they went back in the bag and straight into a nanocooler, where they were kept at a temperature just above freezing.That’s when the couriers arrived. The cooler was loaded onto a plane and sent to Kite Pharma, a T cell training center in El Segundo, Calif., lined with stainless steel tanks. White gowns, double gloves, and no makeup: inside a CAR-T factory Privacy Policy Leave this field empty if you’re human: Last week, a month after treatment, Matthews returned to Dana-Farber with Diane at his side and learned that he recorded a partial response. That means the CAR-T therapy had reduced his tumor burden, but the cancer has not vanished.“So he goes into that 75 percent or so who are showing a response, and we’re hoping he’s going to fall into the complete response group” in the coming months, said Nikiforow, pausing to knock three times on a wooden table.“I look at the news that I was given today as a home run,” Matthews said.His next scan is on the calendar for December, and he’s hopeful that, given more time to percolate in his veins, his newly trained T cells will perform even better.But even if they don’t, Matthews is effusive about the hope CAR-T might offer to others. Since his diagnosis, he’s been an active member of online communities for lymphoma patients, passing on positive thoughts and consolation. “At 51 years old, I have a lot of life left in me — a lot of good left to do in this world. And I’m not the only one.” Related: [email protected] “We all know someone — family, friends, someone in our community — who has cancer,” Matthews said. “I look at my subgroup, my cancer, and I think, what if this wasn’t available to me? At 51 years old, I have a lot of life left in me — a lot of good left to do in this world. And I’m not the only one. With this therapy, hundreds, maybe thousands, of lives will be saved, and think of those people and all the good they’ll do in their lives. We can’t quantify that.”Matthews didn’t have to pay for his CAR-T therapy; because he got it in a clinical trial, Kite — which is a division of Gilead Sciences — picked up the tab. Future patients may not be so fortunate.The first CAR-T to win regulatory approval, from Novartis, carries a list price of $475,000 for a one-time dose. The one Matthews received goes for $373,000. And that’s just for the treatment; it doesn’t include all the hospital costs.“We have to figure out how to make these treatments available to everyone,” Matthews said. “There’s good in all of us, and everyone should be afforded the same experience and opportunity I had.”Editor’s note: This story was updated to reflect the dosage of T cells needed for CAR-T therapy. Kite was ready. The day Matthews joined the CAR-T trial, the company had assigned him a one-of-a-kind ID number so they could track his T cells on their flight west. Once the bag arrived in the nanocooler, it was tagged with a bar code representing that ID.It’s a deeply important and practical measure, as a mix-up could lead to a patient receiving someone else’s cells, with disastrous results.But it also has a humanizing effect on the manufacturing process, as every Kite employee knows they are working on a bespoke treatment for a particular patient.“You know their life is in your hands,” said Tim Moore, Kite’s executive vice president of technical operations. “I can honestly say people really get that and are highly motivated to make a difference for that patient.” National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. About the Author Reprints Related: One big cancer breakthrough is likely on the way to patients. Here’s what may be coming next last_img read more

Pharmalittle: Novartis wins added use for its CAR-T drug; former Valeant exec faces a fraud trial

first_img 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. By Ed Silverman May 2, 2018 Reprints Pharmalittle: Novartis wins added use for its CAR-T drug; former Valeant exec faces a fraud trial What is it? Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today boasts the aroma of blueberries — and get started. Meanwhile, do keep us in mind if you hear anything interesting. Hope you have a productive and meaningful day …The fraud trial of a former Valeant Pharmaceuticals (VRX) executive is set to begin this week in Manhattan federal court, the first criminal prosecution to emerge from multiple investigations into the embattled drug maker over its sales practices, The Wall Street Journal writes. Using a statute often applied to public corruption cases, prosecutors accused Gary Tanner and a co-defendant, Andrew Davenport, of defrauding Valeant through an alleged multimillion-dollar kickback scheme involving Philidor Rx Services, a specialty mail-order pharmacy. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What’s included? 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. Pharmalot center_img Log In | Learn More GET STARTED Tags legalopioidspharmaceuticalspharmalittleSTAT+ About the Author Reprints @Pharmalot Alex Hogan/STAT [email protected] Ed Silvermanlast_img read more