Month: June 2021

FDA explains why it approved Addyi female sex pill

first_img Addyi was approved by the FDA last summer. Allen G. Breed/AP About the Author Reprints PharmalotFDA explains why it approved Addyi female sex pill New pill for boosting female libidos off to a slow start Related: Instead, they mentioned how the drug was previously bounced by an FDA advisory committee – and the agency itself – in the past for poor showings in clinical trials. And they reviewed results of more recent clinical trial work, which continued to raise questions about effectiveness and side effects that could occur if Addyi is taken with some other drugs or mixed with alcohol.The essay acknowledged there was debate about the extent to which medicines should be used to treat female sexual dysfunction. And the staffers made a point of stressing that the FDA ordered follow-up studies to resolve safety concerns and implemented a so-called risk program that requires physicians to undergo a brief certification before they are allowed to write prescriptions.But about the only time the FDA staffers displayed anything other than clinical detachment was when they referred to “erroneous claims” the agency had approved more than 20 pills to help men with sexual problems. That campaign, by the way, was partly funded by Sprout Pharmaceuticals, which held the rights to the drug. (Sprout is now owned by Valeant Pharmaceuticals.)In short, the essay is a helpful cheat sheet for anyone who missed the to-do. @Pharmalot Ed Silverman Should the Food and Drug Administration have approved the Addyi pill for female sexual dysfunction?The question has been asked repeatedly ever since the agency endorsed the drug last summer, following an orchestrated campaign that charged FDA officials were biased against such drugs for women while men had many options to combat impotence. The regulator was then criticized for approving the drug, despite safety concerns and data showing the pill was not very effective.Now, the FDA has responded to its numerous critics, some of whom argued the agency lowered the bar by granting approval. But FDA officials did so in a rather understated fashion. Anyone who hoped the agency might have acknowledged missteps will be disappointed.advertisement Pill for women’s libido carries sobering risk The FDA has previously used NEJM as a forum to explain its views. Last year, for example, several agency staffers defended their decision to approve a drug known as Brisdelle to reduce hot flashes during menopause, even though an advisory panel recommended against such a move. And two months ago, FDA officials disclosed a request for drug makers to run new studies in testosterone-lowering drugs to resolve ongoing safety concerns.As for Addyi, the agency staffers wrote how “robust” discussions are always held when drugs are reviewed for approval and that a variety of views — from inside and outside the FDA — were considered. The essay concludes with the notion that the FDA can take regulatory action if the additional study data suggests a need to rethink whether the drug is truly suitable. “This seems like a reasonable approach that balances safety and access,” they wrote.Meanwhile, demand for the pill remains anemic. Through Nov. 27, a total of 689 prescriptions were written, up from 80 through the end of October, according to IMS Health, the market research firm. The poor showing is likely due to publicity over side effect concerns and a lack of consumer advertising, which Sprout volunteered not to run for 18 months. [email protected] Related: In a four-page essay published in The New England Journal of Medicine, a group of agency staffers recounted the unusual events surrounding the Addyi regulatory review and the ensuing controversies. And they did a nice — albeit, somewhat perfunctory — job of summarizing the many twists and turns.The piece, however, did not offer a mea culpa or indicate that FDA officials have second thoughts about how the Addyi review was handled.advertisement By Ed Silverman Dec. 9, 2015 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags AddyiFDAsexual dysfunctionlast_img read more

Harried flight, marathon surgery behind first US penis transplant

first_img Privacy Policy The timing could hardly have been worse. Just when an organ became available for the first-ever penis transplant in the United States, almost every last urologist in the country was at a conference in San Diego, Calif.Within 24 hours, Dr. Dicken Ko would be back in Boston performing the operation. He booked the next flight he could find, and called a colleague so that the operating room would be ready. Ko’s wife picked him up at the airport in the middle of the night, and drove him straight to Massachusetts General Hospital, where he is the director of urology.On one table was the donated penis, kept on ice. On another was the patient, Thomas Manning, a 64-year-old bank courier from Halifax, Mass.advertisement Related: By Eric Boodman May 16, 2016 Reprints [email protected] Eric Boodman In 2012, Manning had gone into the hospital because of an accident in the mailroom where he worked. His injury was in his groin area, but when the doctors began examining him, they saw something else: a growth that looked like penis cancer. “He hadn’t recognized it himself,” said Dr. Adam Feldman, Manning’s oncologist at Mass General. @ericboodman Leave this field empty if you’re human: This operation has been attempted before overseas. Surgeons have been successful at re-attaching patients’ own penises for years, but in 2006, two weeks after Chinese surgeons grafted a cadaver’s penis onto a patient, he asked for the transplant to be removed, for psychological reasons. Then, in 2014, surgeons in South Africa performed a penis transplant on a 24-year-old man who had lost his organ because of infection after a ritual circumcision. Just six months after the transplant, the patient told his surgeons that his girlfriend was pregnant.In February, surgeons at Johns Hopkins announced that they had selected a soldier wounded in a bomb blast in Afghanistan as the first American recipient for a penis transplant, but they were still practicing the procedure on cadavers in April.“We hope that this will be a common part of reconstructive surgery going forward,” said Dr. Curtis Cetrulo, who led the surgical team at Mass General, at a press conference on Monday. He noted that for soldiers returning from Iraq and Afghanistan, genital injuries “can leave them so despondent that they consider taking their own lives, and often do.”The operation could also potentially have implications for those who identify as transgender and who may want surgery. But, for the moment, the team at Mass General is focused on wounded warriors, cancer patients, and those who have suffered accidents. “The anatomy is very different,” explained Ko, adding that performing a penis transplant on someone who had been born with a female body would require a whole other set of studies.Cetrulo said that Manning will most probably be on immunosuppression for the rest of his life, which could put him at an increased risk of infections and certain cancers. He still has a catheter in at the moment, but he should be able to urinate normally within weeks, and sexual function may be restored within weeks or months.Correction: A previous version of this story misstated the amount of time Manning spent on the waiting-list for a donated organ. And after a battery of tests both physical and psychological, and a wait of a few weeks, the operation began on May 8, when an organ from a deceased donor became available. In order for that donated penis to be used for this experimental operation, the New England Organ Bank asked for special permission from the donor’s family.The surgeons began with the urethra, suturing the donor organ to Manning’s stump under a microscope. “That anchors everything down,” Ko told STAT.Then they could wire up the blood vessels and the nerves. But just then, they ran into a problem. The pre-op scans had made it look like Manning’s arteries were flowing well enough to simply suture them together with those in the donor organ.But one artery was not big enough. “You could see the diameter was too small. Most experienced surgeons can tell that,” Ko said.So they moved immediately to plan B: They took a bit of a blood vessel from the top of Manning’s leg and spliced it in to ensure proper blood flow.The operation lasted approximately 15 hours. Manning is doing well. On Friday, less than a week after the operation, he was out of bed, according to the New York Times. About the Author Reprintscenter_img In a 15-hour procedure earlier this month, a Massachusetts man received the first penis transplant in the US. AP Video Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. HealthHarried flight, marathon surgery behind first US penis transplant To increase his chances of survival, the team had had to amputate most of his penis, leaving little more than a stump. Manning proposed himself as a candidate for a penile transplant.advertisement First penis transplant surgery in the USVolume 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 Linkhttps://www.statnews.com/2016/05/16/penis-transplant/?jwsource=clCopied EmbedCopiedLive00:0000:4500:45  General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. Watch: First penis transplant surgery in the US carried out in Boston Please enter a valid email address. Tags Massachusetts General Hospitalpenis transplantlast_img read more

Special drug rushed to help brain-eating amoeba patient

first_img About the Author Reprints Associated Press The Naegleria fowleri amoeba seen under the microscope. Dr. Visvesvara/CDC Miltefosine was originally developed to fight cancer in the 1980s. It also helps fight leishmaniasis, a disease cause by a parasite transmitted through sand flea bites in tropical climates, MacLaughlan said.This is just the second time his company has sent the specialized drug that costs about $48,000 for a round of treatment to a hospital. It was delivered as capsules, MacLaughlan said.Officials aren’t releasing the name, age, sex or condition of the patient, currently being treated at the Medical University of South Carolina hospital in Charleston. Please enter a valid email address. The patient in South Carolina was confirmed on Tuesday to have been exposed to Naegleria fowleri, a one-celled organism that can cause primary amebic meningoencephalitis, the Centers for Disease Control and Prevention reported. Privacy Policy Related: Between 2006 and 2015 there have been 37 infections in the United States. Only three people have been recorded to have survived exposure. Miltefosine was used to treat one of the survivors — a 12-year-old girl in Arkansas, the CDC said.advertisementcenter_img Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. COLUMBIA, S.C. — A pharmaceutical company has rushed a special drug that once saved the life of a girl who contracted a usually deadly brain-eating amoeba to a South Carolina hospital with its own patient fighting the disease.A courier drove the drug, called miltefosine, six hours from the company’s Orlando, Fla., headquarters to Charleston as soon as the hospital called around 10 p.m. Tuesday, Profounda CEO Todd MacLaughlan told the Associated Press.“Time is of the essence,” MacLaughlan said.advertisement Scientists scour the globe for a drug to kill deadly brain-eating amoeba HealthSpecial drug rushed to help brain-eating amoeba patient By Associated Press Aug. 3, 2016 Reprints Leave this field empty if you’re human: The patient appears to have been exposed to the amoeba while swimming July 24 near Martin’s Landing on the Edisto River in Charleston County, South Carolina Department of Health and Environmental Control epidemiologist Linda Bell said in a news release.The amoeba lives in many lakes, rivers, and streams in warm water locations. There has to be a lot of force to send the water and amoeba into the brain, either by jumping into the water, or in a recent fatal case where an 18-year-old Ohio woman fell out of her raft in the churning waters at the US National Whitewater Center in Charlotte, N.C.Health officials recommend swimmers hold their noses or wear nose clips when jumping feet first into freshwater lakes and rivers, warning the lower the water level and the warmer the water, the greater the risk of contracting the amoeba. Tags amoebabrainlast_img read more

After train crash, transit regulators targeting sleep apnea

first_imgHealthAfter train crash, transit regulators targeting sleep apnea By Associated Press Nov. 21, 2016 Reprints Privacy Policy Please enter a valid email address. The engineer in September’s New Jersey commuter train crash that killed a woman and injured more than 100 people was found to have sleep apnea. Chris O’Neil/National Transportation Safety Board via AP Airplane pilots with sleep apnea aren’t allowed to fly unless they’ve been successfully treated. Regulators are also pushing for bus and truck drivers to get tested.NJ Transit engineer Thomas Gallagher, 48, was diagnosed with severe sleep apnea about a month after his train slammed into Hoboken Terminal at double the 10 mph speed limit on Sept. 29, his lawyer said. One woman on a platform was killed by falling debris. More than 100 people were injured.Gallagher had passed a physical in July and was cleared for duty, lawyer Jack Arsenault said. The engineer told investigators he felt fully rested when he reported to work. He said he had no memory of the crash and only remembered waking up on the floor of the engineer’s cab.NJ Transit already tests for sleep apnea, but updated its rules last week to prevent diagnosed engineers from operating trains until they’re fully treated, Feinberg said. It is not clear if Gallagher was screened.NJ Transit declined to answer questions about its screening program, saying it was not authorized to discuss an employee’s medical information and couldn’t discuss specifics about the crash while federal investigators continued their probe.Sleep apnea also went undiagnosed in the engineer of a commuter train that sped into a 30 mph curve at 82 mph and crashed in New York City in 2013, killing four people. He had fallen asleep at the controls. A deadly freight train crash in 2011 in Iowa and another freight crash in 2013 Missouri have also been attributed to sleep apnea.Metro-North started testing for sleep apnea after the 2013 crash. Metro-North’s screening program has found sleep apnea in 51 of its 438 engineers and trainees, spokesman Aaron Donovan said. They are undergoing treatment, he said. Related: Associated Press NEW YORK — Federal regulators are urging railroads across the country to test train operators for obstructive sleep apnea after the engineer in September’s deadly New Jersey commuter train crash was found to have the fatigue-inducing disorder.The Federal Railroad Administration will issue a safety advisory this week stressing the importance of sleep apnea screening and treatment, Administrator Sarah Feinberg told the Associated Press. One railroad that already tests its engineers, Metro-North in the New York City suburbs, found that 1 in 9 suffers from sleep apnea.The advisory, akin to a strong recommendation, is a stopgap measure while regulators draft rules that would require railroads to screen engineers for sleep apnea. That process could take years, and Feinberg said railroads shouldn’t wait for the government to force action.advertisementcenter_img “At this point it’s unacceptable to wait any longer,” Feinberg said.Sleep apnea is especially troubling for the transportation industry because sufferers are repeatedly awakened and robbed of rest as their airway closes and their breathing stops, leading to dangerous daytime drowsiness.advertisement Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Volpe center tackles train crashes, bike traffic, and booze About the Author Reprints Tags sleep apneatransportation Leave this field empty if you’re human: The Long Island Rail Road is in the process of starting a testing program.The FRA first recommended sleep apnea testing in a 2004 safety advisory, but Feinberg said most railroads are still not doing enough to address the issue.“This is one more thing railroads can do to keep their passengers safe and the communities they’re traveling through safe,” Feinberg said.The FRA also wants railroads to install inward-facing cameras in train cabs to record engineers’ actions and aid crash investigations.Democratic Senators Cory Booker and Bob Menendez, of New Jersey, and Charles Schumer, of New York, sent a letter last week asking the FRA to investigate whether there were any problems in the NJ Transit screening program that could’ve led to the Hoboken crash.“The bottom line is that we must do all we can to prevent rail accidents in an era where the demands on rail are ever increasing,” Schumer said. “And so, these safety advisories are a crucial and positive step, and I hope all railroads will comply quickly.”— Michael Balsamo and Michael R. Sisak “You end up with an engineer who is so fatigued they’re dosing off, they’re falling asleep in these micro bursts and they often have no memory of it, and they’re operating a locomotive at the time, so they’re putting hundreds of people in danger,” Feinberg said.last_img read more

R&D spending may not really justify those high prices, after all

first_img Log In | Learn More Pharmalot Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. For years, the pharmaceutical industry has maintained that high prices charged for many medicines in the US are needed to fund R&D, since so many other countries use various means to cap pricing.Now, though, a new analysis suggests that the additional sales that drug companies generate in the US, compared with four other well-to-do countries, greatly exceeds what they have spent on their global research and development. By Ed Silverman March 8, 2017 Reprints 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. What is it? @Pharmalot 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.center_img What’s included? APStock R&D spending may not really justify those high prices, after all [email protected] Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED About the Author Reprints GET STARTED Tags drug pricingpharmaceuticalsSTAT+last_img read more

Deported veterans should not be denied the health care they’ve earned

first_img With hand cream and insulin, a clinic struggles to care for undocumented immigrants [email protected] Leave this field empty if you’re human: In the absence of a strong safety net, it is no surprise that veterans get caught up in our criminal justice system. Instead of treating the wounds of war, we punish people like Armando with prison, deportation, and the loss of much-needed health care.We owe more than a debt of gratitude to our veterans for their sacrifice. People like Armando deserve treatment and citizenship. The VA system must do more to safeguard veterans from the vulnerabilities that land them in our jails and prisons. And our lawmakers need to support initiatives that protect veterans from deportation and the loss of health care.As a country, we can do better. We must commit to protecting those who risked everything to protect us — regardless of their citizenship status.Lello Tesema, M.D., is a general internal medicine physician and director of population health at the Los Angeles County Correctional Health System. Stephen Merjavy, M.D., is an HIV and family medicine physician at Contra Costa Health Services in California. By Lello Tesema and Stephen Merjavy Dec. 19, 2017 Reprints Privacy Policy Each year, around 8,000 noncitizens enlist in the military. In 2008, the U.S. Department of Defense estimated that more than 65,000 immigrants (noncitizens and naturalized citizens) were serving on active duty in the U.S. armed forces. That represented approximately 5 percent of all active-duty personnel. Enlisting in the military can expedite the process of becoming a citizen — but it doesn’t guarantee it.A conviction for something as minor as drug possession can result in automatic deportation. According to a report from the ACLU of California, thousands of foreign-born veterans are now scattered across the globe following deportation. Under President Trump, thousands more face the risk of arrest and deportation.As many as 1 in 3 veterans suffer from post-traumatic stress disorder. They struggle to keep jobs and adjust to civilian life. As a result, veterans are much more likely to become homeless and succumb to crimes of poverty.A staggering number of veterans struggle with addiction, and the numbers seem to be climbing. Among veterans who are incarcerated, some are able to access treatment. “Deportable” veterans, however, are barred from treatment by the Bureau of Prisons while they do time. And once deported, veterans can no longer access the VA health care system, depriving them of the VA benefits to which they are entitled.A current bill package proposed by Rep. Juan Vargas (R-Calif.) offers some steps in the right direction. If passed, this bill would fast-track the naturalization process for noncitizen veterans and would also allow veterans who have been deported to temporarily return to the U.S. to get medical care at the VA. But efforts to move this bill forward seem to have stalled.Armando’s appeal for humanitarian parole was recently denied. Without the kind of care he could — and should — get at the nearby VA health facility, the treatable infection that is damaging his bones may someday make it impossible for him to walk. Stephen Merjavy Once back in Mexico, things got worse. Armando was in a serious car accident that left him permanently disabled and caused chronic infections. Now he waits, living in a shack at the edge of a friend’s property with his small dog, hoping he might one day get treatment — treatment he is entitled to as a veteran — at the VA medical facility just 30 miles away.As physicians who work with immigrants and those in the justice system, Armando’s story is both tragic and familiar.advertisement Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Please enter a valid email address. Related: A U.S. Marine veteran who was deported looks out from his apartment balcony in Tijuana, Mexico, where he can see the U.S. border wall. Gregory Bull/AP First OpinionDeported veterans should not be denied the health care they’ve earned About the Authors Reprints [email protected] Lello Tesema Armando limped into the waiting room of the support house for deported U.S. veterans in Tijuana, Mexico. We were there to evaluate him for humanitarian parole, a process by which an individual banned from the United States can appeal to return on a temporary basis for an extenuating circumstance — in Armando’s case, medical care for a disabling bone infection at a VA facility just across the border in San Diego.Born in Mexico, Armando came to the U.S. as a child. When he came of age, he enlisted in the armed forces and served several tours of duty in Korea and Germany. During his service, he developed addictions to alcohol and opioids.After being honorably discharged from the service, Armando returned to the U.S. A few years later, a drug charge landed him before a judge. Addiction is a common problem in the military, and courts have recently begun to offer veterans treatment instead of jail time. But instead of being offered treatment, Armando was deported to Mexico.advertisement @ltesema Tags advocacylegislationveteranslast_img read more

In a scientific first, cloned monkeys are born. Will they accelerate biomedical research?

first_img Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. Leave this field empty if you’re human: Regular monkeys, not clones, “may more closely model the genetic variability in humans,” agreed MIT’s Desimone. “It is important to eventually understand the role of a variable genetic background.” If cloned monkeys were available, he added, “I am sure that some drug companies and some primate researchers would want to try them. … I see the cloning as a positive development with potential applications, although not transformative.”Two important obstacles to more widespread biomedical use of monkeys, cloned or not, are ethics and cost. Using monkeys in biomedical research is “far more expensive, difficult, and morally fraught” than using rodents, said Lowe. And primate research has seen “egregious ethical violations,” said Dr. John Pippin of the Physicians Committee for Responsible Medicine, which supports alternatives to animal research. Monkeys’ dissimilarities to humans, including in brain structure, function, and genetics, makes them poor models for complex human psychiatric diseases, he said, and cloning monkeys “expands the ethical objections” if it increases the research use of humans’ closest relatives.Zhong Zhong and Hua Hua are growing normally and playing in their toy-filled enclosure. More monkeys are pregnant with clones, with due dates in the coming months. Some were created from adult, not fetal, cells. [email protected] By Sharon Begley Jan. 24, 2018 Reprints Exclusive analysis of biopharma, health policy, and the life sciences. In the LabIn a scientific first, cloned monkeys are born. Will they accelerate biomedical research? Related: There have been mice and cows and pigs and camels, bunnies and bantengs and ferrets and dogs, but ever since Dolly the sheep became the first cloned mammal in 1996, the list has had a conspicuous hole: primates. Now that hole has been filled.Scientists in China reported on Wednesday in Cell that they had cloned two healthy long-tailed macaque monkeys from the cells of another macaque, using the Dolly technique. The two clones, born 51 and 49 days ago, were created from a fetus’s cells; so far, the scientists have not been able to make the tricky procedure work when they used cells from adult macaques. That would seem to postpone the dystopian day when cloning children and grown-ups becomes as mainstream as IVF. But because “the technical barrier [to cloning primates] is now broken,” co-author Mu-ming Poo of the Institute of Neuroscience in Shanghai told reporters, the technique “could be applied to humans” — something he said his team has no intention of doing and sees no reason for.Cloning pioneers said the monkey clones represented, as Dr. Robert Lanza put it, “an impressive breakthrough, which overcomes the last major hurdle in the field.” Lanza co-led teams that cloned a gaur in 2000 and in 2014 used the Dolly technique to produce human embryos (but not pregnancies) from the cells of an adult.advertisement “Most of the time the SCNT eggs don’t even produce an embryo,” Mitalipov said. But the Shanghai team produced hundreds of cloned monkey embryos, thanks to two chemicals: adding one called trichostatin A while and after the ovum was faux-fertilized, and then a molecule called Kdm4d once embryos formed. Together they reprogrammed the donor DNA, awakening genes needed to produce an entire organism. That increased the percentage of SCNT eggs that developed into embryos, and also improved the embryos’ quality, making them more like naturally fertilized eggs.The efficiency was still very low. Trying to produce clones from adult monkey cells, the scientists got 192 embryos from 290 tries, with 22 pregnancies and two monkeys born alive; both died within hours. Using cells from fetuses, they got 109 embryos from 137 tries, six pregnancies, and two live births. They are Zhong Zhong and Hua Hua, both females and, since they came from cells of the same monkey, identical twins. “Zhonghua” means Chinese nation.Experts disagree on whether, as the Chinese scientists argue, monkey clones would accelerate biomedical progress.“There is a strongly held belief that monkeys will be better models because of greater similarities in brain and behavior,” said neuroscientist Robert Desimone of the Massachusetts Institute of Technology and director of the McGovern Institute for Brain Research. “Too many failed clinical trials [of neurological and psychiatric diseases] in humans have been based on mouse models that turn out to be not predictive.” The cloning team said its breakthrough might one day be used to produce genetically identical monkeys for biomedical research. Most of the lab animals used to study diseases, from cancer to Alzheimer’s, are highly inbred mice. But mice don’t get every human disease or don’t get it the way people do. Mice genetically engineered to express the human cystic fibrosis gene, for instance, don’t develop that disease’s characteristic lung problems, and mice don’t mimic human neurological and psychiatric diseases such as schizophrenia and autism very well.advertisement Sharon Begley Zhong Zhong, one of the first two monkeys created by somatic cell nuclear transfer. Qiang Sun and Mu-ming Poo/Chinese Academy of Sciences Related: Please enter a valid email address. Because humans share more of their DNA with primates than mice, cloning monkeys “opens up new possibilities for studying the genetic basis” of human traits and behaviors, Lanza said. “For instance, if there is one monkey that really likes to drink, and if scientists could clone it, they could find out whether [the behavior] has a genetic basis.”On the other hand, although “you’d have to think that effects on higher [brain] functions would be more realistic in a [monkey] model, you’re still faced with the extreme difficulty of figuring out just what those effects are,” said Derek Lowe, a pharmaceutical chemist and blogger. “A monkey can’t tell you that he’s feeling a bit fuzzy, or is hallucinating. How would you pick up a side effect of suicidal ideation, for example? Or how would you be sure that a monkey is depressed, as opposed to (say) just mildly nauseated or tired all the time?”Nor is it clear if cloned monkeys would be better than monkeys that are genetically diverse, like people. Clones might respond to experimental drugs or genetic manipulation more uniformly, producing cleaner experimental results. But genetic sameness might backfire, said Nadia Rosenthal, scientific director of the Jackson Laboratory, whose inbred mice are used by scientists around the world: Results on genetically uniform mice often apply only to that strain, not others, making them problematic models for studies that aim for broad, robust conclusions on, for example, “effects of mutations, diets, toxins, or drugs.” To mimic humans, she said, “we need more genetic diversity, not less.” Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Zhong ZhongVolume 90%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 Linkhttps://www.statnews.com/2018/01/24/first-cloned-monkeys-dolly-research/?jwsource=clCopied EmbedCopiedLive00:0000:4700:47  Zhong Zhong and Hua Hua, the first monkey clones created by somatic cell nuclear transfer. QIANG SUN AND MU-MING POO/CHINESE ACADEMY OF SCIENCES If monkey clones can be created routinely, they can also be genetically altered, one gene at a time, with techniques such as CRISPR. “You can produce cloned monkeys with the same genetic background except the gene you manipulated,” senior scientist Qiang Sun told reporters. “This will generate real models not just for genetically based brain diseases, but also cancer, immune, or metabolic disorders.”Postdoctoral fellow Zhen Liu spent three years optimizing the Dolly recipe for primates. Called somatic cell nuclear transfer (SCNT), the technique involves fusing a somatic cell — meaning anything other than a sperm or ovum — with an egg whose nucleus has been removed. (Zapping the egg with laser light helped, Liu found.) An hour or two later he used two chemicals to faux-fertilize the egg (no sperm needed), spurring it to start developing into an embryo.The DNA in the somatic cell took over. As the egg divides and divides, the resulting embryo is a genetic copy of the animal the somatic cell came from. If transplanted into a surrogate mother, it develops into a fetus and, if all goes well, a newborn. In reality, no one had managed to get live births of cloned primates. A big stumbling block was that DNA from the somatic cell resisted reverting to its embryonic state where it is able “to express all the genes needed for embryonic development,” Poo said. Before this, “no one was able to produce living offspring” through primate cloning, said Shoukhrat Mitalipov, of Oregon Health and Science University, who in 2013 also used the Dolly technique to create human embryos (technically, blastocysts) from the cells of an 8-month-old. (He did not use the embryos to create pregnancies either.) “These guys made it work, which is quite an achievement.” Privacy Policy About the Author Reprints First human-pig chimeras created, sparking hopes for transplantable organs — and debate Dolly the sheep died young, but her cloned sisters are still alive and kicking STAT+: @sxbegle Tags CRISPRdrug developmentethicsgeneticsresearchlast_img read more

Glaxo ‘turns back the clock’ and resumes payments to doctors

first_img GET STARTED Glaxo ‘turns back the clock’ and resumes payments to doctors In an unexpected move, GlaxoSmithKline (GSK) will resume payments to doctors who help promote some of their medicines, reversing a policy begun five years ago after marketing scandals that led, in part, to an infamous settlement with U.S. authorities.Going forward, the company will pay doctors who speak on its behalf for “select” products in the U.S. and Japan, but this could extend to major markets in Europe, North America, and Asia starting next year. Nonetheless, Glaxo insisted total payments will be “significantly lower” than before the old policy was announced in 2013. Ed Silverman Sang Tan/AP Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. 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 [email protected] What is it? By Ed Silverman Oct. 2, 2018 Reprints About the Author Reprints 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. @Pharmalot Tags pharmaceuticalsphysiciansSTAT+last_img read more

Flu season is coming. If you live in a large city, it may stretch longer than elsewhere, study says

first_img Helen Branswell By Helen Branswell Oct. 4, 2018 Reprints Privacy Policy About the Author Reprints Leave this field empty if you’re human: What they saw was that in small cities, the curve of a flu season was sharp. Regardless of whether a lot of people got sick in a flu season or whether fewer were struck in a particular year, most of the infections occurred over a short period of time, making for a “spiky” epidemic curve.But the pattern in large cities was different. The curve was lower and longer — more diffuse. It didn’t mean that fewer people got sick, but that infections were spread out over a longer period of time.It meant that flu viruses were still able to spread from person to person in large cities even when climatic conditions weren’t ideal.Dalziel, who admitted the big-city pattern wasn’t what he and his colleagues were expecting, said the small city outbreaks were “explosive” while the big city epidemics “smoldered.”Their conclusion was that specific humidity didn’t matter as much in places where large numbers of people live.“The flu is able to spread under a wider envelop of climatic conditions in the metropolises, because of highly organized movement patterns that put people into such close proximity that the specific humidity starts to matter less,” Dalziel said. “In metropolises, flu is able to eke out a living because there’s more highly organized close contact.” Trending Now: HealthFlu season is coming. If you live in a large city, it may stretch longer than elsewhere, study says Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Spencer Platt/Getty Images Seema Lakdawala, who studies influenza transmission, described the finding as fascinating.“What they’re showing is that the transmission dynamics within intense urban areas is more perpetual,” said Lakdawala, an assistant professor in the department of microbiology and molecular genetics at the University of Pittsburgh School of Medicine.Lakdawala studies how the flu virus is transmitted — through droplets of saliva or mucus that can only travel short distances, or through aerosols, which can hang in the air longer. Her read of this study suggested to her that in smaller places, aerosolized viruses may play more of a role in transmission, and those may be more dependent on climatic conditions. But in large centers where people are more densely packed, transmission over short distances — which is less climate-dependent — can get the job done.“Since I’ve been thinking about the importance and the contribution of short-range versus long-range transmission for so long, to me it really fits,” said Lakdawala, who was not involved in the research.“In intense urban areas, we’re indoors more often. So this idea that there is transmission occurring universally, constantly, in these environments that isn’t necessarily driven by seasonality of humidity is really fascinating,” she said. “And it really fits with what we think is happening — that these long-range transmission events may be more sensitive to humidity conditions, and they may be happening more in less populated areas.” Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. @HelenBranswell “If there’s lots of people and transportation patterns frequently bring them together, it helps the virus find new hosts even when climate conditions aren’t at their most favorable,” explained lead author Benjamin Dalziel, an assistant professor in the department of integrative biology at Oregon State University in Corvallis. CDC: 80,000 people died of flu last winter in U.S., highest death toll in 40 years “This is important for policymakers because it indicates that metropolitan areas should focus on reducing influenza spread, whereas small towns should focus on reducing harm,” Wallinga wrote in a commentary on the paper, which was published alongside it Thursday in the journal Science.Influenza is famously unpredictable. It’s not uncommon to hear people who have studied it for decades describe the virus as “humbling.”Experts know there will be a surge of influenza infections at some point in the year; in the Northern Hemisphere that period typically falls in the stretch from late autumn through late winter or early spring. But some years the peak of infections will occur over Christmas and other times the sickest point in the season will come in late February or even March.It’s not fully understood why flu behaves this way. Time spent indoors during the winter, when their immune systems may not be as robust, is thought to be a factor.Dalziel and his co-authors set out to look at the role specific humidity levels — how much moisture there is in the air — play in flu transmission. They used a large amount of data: weekly health insurance claims from people who sought care for influenza-like illness. The researchers had data by ZIP code for six years, from 2002 to 2008, for roughly 603 cities in the United States. Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Please enter a valid email address. The finding suggests a one-size-fits-all approach to flu season preparedness won’t work. If the study is correct, small centers should work on surge capacity — their ability to handle a lot of sick people over a short period of time — while larger cities should find ways to reduce transmission, said Jacco Wallinga, an expert on infectious diseases modeling at the National Institute for Public Health and the Environment in the Netherlands.advertisement The length of the flu season may vary depending on where you live, with large cities enduring longer periods of transmission and smaller cities experiencing shorter, but more explosive, spread, a new study suggests.The study doesn’t assert that one’s risk of contracting influenza varies depending on the size of any given community. Rather, it argues that in less populous places, flu needs the right atmospheric conditions to spread effectively.In large cities, those conditions don’t matter quite as much.advertisement Related: Tags infectious diseasepublic healthlast_img read more

Gawande, still mum on plans for new health venture, pulls out of major health conference

first_imgBusiness 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? National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. By Casey Ross Jan. 17, 2019 Reprints If ever there was a celebrity in health care, it was Dr. Atul Gawande. He frequented the biggest stages in media and medicine. He gave TED talks, interviews with top journalists, and moderated a discussion on health innovation with President Obama. His books and essays for the New Yorker made him not just a sought-after speaker, but the unofficial leader of medicine’s less-is-more movement.At least, until six months ago, when he became a CEO. Since drawing tremendous attention when he was dispatched by the leaders of Amazon, JPMorgan Chase, and Berkshire Hathaway to create a venture with the long-term goal of transforming health care, Gawande has virtually disappeared from the public eye. He isn’t giving interviews or releasing information about the direction of the new company. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More [email protected] What is it?center_img Dr. Atul Gawande Aram Boghosian for The Boston Globe @caseymross Casey Ross 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. GET STARTED About the Author Reprints Gawande, still mum on plans for new health venture, pulls out of major health conference Tags BostonHIMSShospitalsinsuranceSTAT+last_img read more