FDA review casts doubt on first drug for combating Duchenne

first_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Update: At the advisory committee meeting on Nov. 24, most panel members voiced doubts that the treatment was effective. A final FDA decision on drisapersen is expected by Dec. 27.The fate of a drug to combat Duchenne muscular dystrophy may be in doubt after Food and Drug Administration staff raised serious concerns about the safety and effectiveness of the treatment. The assessment was contained in documents released on Friday in advance of an FDA advisory panel meeting next week to review BioMarin Pharmaceutical’s drisapersen, one of two new experimental medicines for DMD slated for regulatory review.Listen to the Signal podcast: For boys with Duchenne, and two drug companies, a moment of shared hopeThe FDA reviewers cited “life-threatening” side effects, such as a low blood platelet count and severe kidney damage. They also noted a lack of “substantial evidence” of effectiveness, pointing to a failed late-stage study and an inability to substantiate findings from a mid-stage study showing the mobility of boys taking the drug improved after a six-minute walking test. And they argued that the BioMarin drug did not seem to boost levels of dystrophin, the protein that is missing in boys with DMD and which is meant to be restored by the treatment.advertisement Tags BioMarin Pharmaceuticalduchenne muscular dystrophyFDASarepta Therapeutics @Pharmalot “The development program for drisapersen is extensive for a rare disease and exemplary,” the FDA reviewers wrote. “It is very disappointing that both clinical and biomarker data for drisapersen are inconclusive at this time.”Read more: The fight to save children’s lives — and reshape the FDAThe FDA staff stopped short of recommending that the agency not approve the drug. However, by reading between the lines, that seemed to be the take-away for most industry analysts. “In our view, FDA has made a very clear statement that there is no reason to approve drisapersen,” wrote R.W. Baird analyst Brian Skorney in an investor’s note.advertisement Max and Austin Leclaire both have Duchenne muscular dystrophy. Families have been lobbying the FDA to approve new therapies for the rare disease. Kayana Szymczak for STAT [email protected] center_img Opinion remains divided, however, over what this review will mean for Sarepta Therapeutics, the company with a rival drug called eteplirsen that will be considered by an FDA review panel in January. Leerink analyst Joseph Schwartz thought it did not bode well for the competing treatment. But Needham analyst Chad Messer wrote the Sarepta drug has demonstrated greater safety and effectiveness — albeit in a randomized study of only 12 patients, four of whom received a placebo.One surprise of the briefing documents was that the agency will not ask its panel of outside experts — none of whom are DMD specialists — to vote on whether the agency should recommend the drug. This should give the agency more leeway in its final approval decision as it struggles to balance the demands of families afflicted by the DMD with the need for scientific rigor. PharmalotFDA review casts doubt on first drug for combating Duchenne About the Author Reprints Ed Silverman By Ed Silverman Nov. 20, 2015 Reprintslast_img read more

A Novo Nordisk diabetes drug may save lives, but Wall Street shrugs

first_img A widely anticipated study found that Novo Nordisk’s top-selling diabetes drug Victoza lowered the risk of a heart attack, stroke and death by 13 percent. The results, which were released Monday at the American Diabetes Association annual meeting, mark only the second time that a diabetes drug has demonstrated such a benefit.The study, which involved 9,340 adults with type 2 diabetes and a high risk of a cardiovascular disease, also showed that participants given Victoza had a 22 percent lower chance of cardiovascular death. This was statistically significant. As an added bonus, those given Victoza lost about 5 pounds more than those who were on a placebo.Despite the promising results, reactions have been mixed. In fact, Novo Nordisk stock fell in response.advertisement [email protected] Privacy Policy PharmalotA Novo Nordisk diabetes drug may save lives, but Wall Street shrugs To be sure, the outcome is encouraging. But the Novo findings were similar to the 14 percent risk reduction reported last year for Jardiance, a different type of diabetes drug that is jointly marketed by Eli Lilly and Boehringer Ingelheim. Victoza, which is an injectable medication, by the way, belongs to a class of drugs known as GLP-1, while Jardiance is in the SGLT-2 class.Several months ago, when Novo telegraphed the results, the company described the lowered cardiovascular risk as “significant,” and Wall Street took that to mean the results would be stronger. Consequently, investors are now less enthusiastic about the extent to which the Novo medicine will change the treatment paradigm. One analyst believes it’s too soon.advertisement “The argument for broader use is simple. Diabetics have elevated risk for cardiovascular disease, and, given GLP1s … address this risk, it should be used in all diabetic patients,” even those who can control diabetes with other meds, wrote Sanford Bernstein analyst Ronny Gal. “The pushback is that there is lack of evidence to make this case convincing and the data actually did not contribute much to the case.”But one physician expressed some optimism. Ed Silverman Tags cardiovascular diseasediabetesNovo Nordisk A smartphone diabetes device. David Parry/PA Wire/AP Please enter a valid email address. Newsletters Sign up for Pharmalot Your daily update on the drug industry. Related: “I tried to find something wrong with the trial — something to temper the positive results — but I could not, other than the cost of treatment and the potentially higher rate of pancreatic cancer,” said Dr. Walid Gellad, an associate professor of medicine and cohead of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “In those with high cardiovascular risk, a strong case can be made that one of these two drugs should be used.”A key test will now be whether other clinical trials will demonstrate that there is a so-called class effect at work. In other words, Victoza may not be the only GLP-1 drug that lowers cardiovascular risks, and perhaps the same is true that Jardiance is not the only SGLT-2 that does the same thing.“Most physicians believe all SGLT-2s will produce cardiovascular benefits and, therefore, there is no reason to change prescribing patterns,” wrote David Kliff of Diabetic Investor in a note to clients. “Should this same belief take hold in the crowded GLP-1 category, Victoza could run into the same problem as Jardiance — great data but no jump in (market) share.” About the Author Reprints Leave this field empty if you’re human: Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Widely used diabetes drug found in many Southeastern US streams @Pharmalot By Ed Silverman June 14, 2016 Reprintslast_img read more

First he pioneered a new way of making life. Now he wants to try it in people

first_img PORTLAND, Ore. — The next great advance in fertility treatments may rest with five young monkeys in a lab outside of town.Each of the five carries genes from three parents instead of two, because they were conceived using a novel — and controversial — gene therapy. They seem to be completely ordinary. But researchers are watching them closely to make sure they age normally, can reproduce, and have healthy children.If so, the three-parent fertilization technique will likely be tried in humans, potentially helping women with certain genetic glitches give birth to healthy children. The same approach might also someday provide older women a chance to extend their fertility by freshening up their eggs with contributions from another woman.advertisement Leave this field empty if you’re human: Serious mutations in these 37 mitochondrial genes doom a fetus; slightly milder mutations can lead to muscle weaknesses, heart problems, and intellectual disabilities. Symptoms can turn up at birth or later in life. It isn’t possible to identify a mitochondrial disease in an embryo, so most women who know they are carriers of mitochondrial mutations decide not to have biological children.Hoping to offer them a chance to have genetically related children, Mitalipov has pioneered a method dubbed “three-parent embryos.”Step one: He takes the nucleus out of the egg of the mother-to-be.Step two: He strips a donor egg of its nucleus.Step three: He implants the mother’s nucleus into the donor egg. The resulting cell now contains DNA from two women: The mother’s DNA in the nucleus (where the bulk of genetic material resides) and the donor’s DNA in the mitochondria.The egg is then fertilized in vitro, adding the man’s DNA and — if all goes well — creating an embryo.So far, Mitalipov has tried this only on mice and a handful of monkeys. He is eager to try the technique to prevent human disease.Potential patients are excited, too.“It has given many mitochondrial disease families a lot of hope,” said MaryBeth Hollinger, a New York-based nurse navigator for the advocacy group MitoAction.Of course, families want the procedure to be safe, Hollinger said, but they are willing to take some risks to avoid passing on a devastating disease to their children.‘Too many question marks’Both Mitalipov and his friendly rival in the field, Dieter Egli of the New York Stem Cell Foundation, maintain that changing an egg’s mitochondrial DNA is different from tinkering with the bulk of the genetic material in the nucleus.And Mitalipov believes his energetic young monkeys — Mito, Tracker, Spindler, Spindy, and Chrysta, all rhesus macaques — are living proof that the technique is safe. Leave this field empty if you’re human: The best way to rein in these glitches is to maximize the number of healthy mitochondria, Mitalipov said. Exercise may do that when we’re young, but probably won’t do much to reverse damage once it’s done, he said. He takes “a whole bunch of antioxidants,” hoping to improve his mitochondrial health, though he’s not sure it will make a difference.The more he learns about mitochondria, the more he’ll be able to help people live long, healthy lives, Mitalipov said.Amato, his obstetrician colleague, said Mitalipov deserves more credit for such vision than he’s gotten.“He’s a very understated kind of person,” she said. “He’s sort of a humble guy and goes about his business and doesn’t have to be the rock star. But he really is.” Related: By Karen Weintraub July 8, 2016 Reprints “You don’t want to say ‘My science will help 100 years from now.’ Maybe it will, but I want it while I’m here,” said Mitalipov, who directs the Center for Embryonic Cell and Gene Therapy at Oregon Health & Science University. Related: Tags fertilitygene editingwomen’s health Please enter a valid email address. NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. In interviews at his lab in downtown Portland and his office at the Oregon National Primate Research Center — where a stuffed monkey, a gift to the lab, is one of the few personal touches — Mitalipov laid out his vision for his research and discussed the uproar it’s caused, and what makes it all worthwhile.The son of two teachers, Mitalipov was born in Kazakhstan, then part of the Soviet bloc, and went to college in Moscow. His first research lab was the only one in Moscow studying embryonic stem cells, back when the field was embryonic itself.Now, he’s one of the few researchers in the world to study a type of genetic manipulation — essentially cloning — in hopes of eventually improving human health.And he is a devotee of a genome that few others bother to explore: The mitochondria that provide energy — and their own 37 genes — to every cell in our bodies.Mitochondria are particularly fascinating, Mitalipov said, because they are meticulous timekeepers.“We came to this [mitochondrial] DNA as a genome that probably affects a lot more than we think,” he said with a thick accent and grammatical structure that still betray his Soviet upbringing. “Not only disease, not only aging. … It seems like there was a niche that no one studied … so we built a program around it.”The path to ‘three-parent embryos’In freshman biology, most of us learned that mitochondria are the “powerhouse of the cell,” floating around outside the nucleus and serving as living batteries.The iconic drawings of cells show a few ovals with squiggles inside — but in truth, a normal, healthy cell might have upward of 1,000 mitochondria, each with its own DNA. These genes are inherited only from mothers. (The vastly bigger nuclear genome, of 20,000 genes, is a relatively even mix from mother and father.) Privacy Policy In the LabFirst he pioneered a new way of making life. Now he wants to try it in people Related: Please enter a valid email address.center_img @kweintraub FDA urged to approve ‘three-parent embryos,’ a new frontier in reproduction “So far, nothing,” Mitalipov said.Research in mice suggests there could be some reason for concern.A study published last month in Cell Stem Cell found that even if 99 percent of a mother’s flawed mitochondria were removed through mitochondrial replacement, the remaining 1 percent could still be passed down to future generations and expand to essentially take over the mitochondrial genes.Another study out this week in Nature shows that mice whose nuclear and mitochondrial DNA come from different mothers — in other words, those with three genetic parents — age faster than normal mice, “resulting in profound differences in health longevity.”The studies don’t concern Mitalipov. He focuses on the successes.But he struggles to keep his cutting-edge work funded; he’s entering an American research competition, hoping to win enough money to eventually breed Chrysta and study the third generation of offspring. He jokes about bringing pictures of irresistibly cute monkey babies to convince the judges.He’s also keeping a wary eye on congressional debate about whether to allow mitochondrial replacements in humans.“We’d like to be the first people to do it, since we were the first people to do it in [monkeys],” said Dr. Paula Amato, a fertility specialist and obstetrician at OHSU who collaborates with Mitalipov.There’s simply no way to eliminate all the risks before trying the technique in people, she said.“We’ve done everything we can to show that it likely would be safe, but ultimately you never know until you do it,” Amato said.A humble rock starMitalipov remains fascinated by the area of a woman’s egg cell that falls outside the nucleus. It’s filled with mitochondria, fluid, and the secret ingredients of humanity.“It’s a woman’s egg cytoplasm that gives life, not its nucleus,” he said. Scientists still don’t know what makes a good or bad egg, but it’s clear that “with aging, something goes wrong with cytoplasm activity.”That’s why older women are less fertile than younger ones. “Women in their 40s, their eggs, no matter what you do, doesn’t seem like they’re producing a viable embryo,” he said.But an older woman can successfully carry a pregnancy from a younger woman’s egg. “So everybody knows it’s an egg problem, but people don’t realize which part of the egg is the problem,” he said. “In my lab, we think it is the maturation of the cytoplasm that is the major issue.”The mitochondria we get from this cytoplasm may also determine how long we live.Mitalipov believes his rising blood pressure has something to do with the aging of his mitochondria. After about age 50, mitochondrial mutations rise; after 70, they go through the roof. Mice that are bred to have lots of these genetic errors die substantially sooner than normal mice. Karen Weintraub is an independenthealth/sciencejournalist, journalism teacher, and bookauthor. Such genetic manipulation sounds uncomfortably like “playing God” to some critics. But the scientist behind the fuzzy-haired monkeys pushes on, as he always has, in a career spent on the scientific frontier.At age 54, Shoukhrat Mitalipov has a wrestler’s build and jet-black hair that stands up in spikes. He also has a fierce desire to get results in the here and now.advertisement The UK government approved use of the three-parent technique in humans last year, though no research group has yet done it. In the United States, however, Congress is contemplating banning the approach, known as mitochondrial replacement therapy.And some scientists worry it’s too soon for human trials.“If someone were to proceed with it now, my own view is that’s probably irresponsible. There are so many question marks. I just think it’s premature,” said Paul Knoepfler, a stem cell biologist at the University of California, Davis.At minimum, Knoepfler said, the offspring of these “three-parent” families should be limited to males, so they can’t pass on their mitochondria to the next generation.Despite his hesitations, Knoepfler said he doesn’t doubt that Mitalipov’s heart is in the right place, and praised him for continuing the research.“I appreciate the fact that he’s willing to tackle some really tough things,” Knoepfler said. “He’s been willing to take risks, to really push and invest time and energy into this cool stuff that almost nobody else has been even trying to do until just recently.”Other peers of Mitalipov also respect his work, calling him a serious scientist who isn’t afraid of controversy, but also isn’t out to feed his own ego. They uniformly refer to him as “nice,” though none said they knew him well enough to describe him further.For his part, Mitalipov said he has no real hobbies outside of work and his family. He used to play blues guitar, but now is excited to listen to his favorite music on Pandora. His teenagers showed him how to work the app so he can listen to Stevie Ray Vaughn during his commute.“I cannot keep up with all this technology,” he said.A delicate touch on egg cell surgeryIt takes a very delicate hand to do intricate surgery on egg cells, and in Mitalipov’s lab, only he and one other researcher can do it. He said his eyes are not as good as they used to be, so his colleague recently came in to do research on a freshly donated human egg — just a week after giving birth to her own baby.Mitalipov learned the techniques in Moscow and then honed them as a young PhD student at Utah State University.His first project was aimed at understanding why embryonic stem cells are essentially immortal. “The female germline doesn’t have a clock — it’s always zero,” he said. “That’s why when we get mitochondria from our mother, it’s set at zero, not her age.”An early mentor was Keith Campbell, then in the process of cloning Dolly the sheep — born 20 years ago this week. The young Mitalipov, who still had just a rudimentary command of English, met Campbell at a conference in Utah, and was enthralled. The senior scientist was generous with his time and his tips, and the two bonded over their common interests in science and beer.His whole career, Mitalipov said, has consisted of tinkering with the nuclear transfer techniques that Campbell, who died a few years ago, developed in the mid-90s.“My clinical goal was to use some of the basic knowledge to improve human reproduction,” Mitalipov said. “The IVF platform can be used now to remanufacture gametes, to treat infertility, but also as a platform for gene therapy, which is probably where the future will go.”Spindler and Spindy, two of the monkeys created from the DNA of three parents. Oregon Health & Science UniversityRed flags from recent studiesMito, Tracker, Spindler, and Spindy are now 7; Chrysta has turned 4. Mitalipov said he’s been asked by the US Food and Drug Administration and the UK government to follow them as they age to make sure they remain normal.He also hopes to breed Chrysta to see how her offspring fare, and to study the mitochondrial DNA she passes on to them.Monkeys don’t reproduce until they’re 6 or 7 — and they live 15 to 20 years in captivity — so it will be a long wait to figure out if these animals have any health problems. Privacy Policy About the Author Reprints Shoukhrat Mitalipov Daniel Berman for STAT New advances in growing human embryos could prompt ethical firestorm Karen Weintraub Newsletters Sign up for Weekend Reads Our top picks for great reads, delivered to your inbox each weekend. Beyond three-parent babies: New drugs offer hope for mitochondrial disease last_img read more

Organ network mapping a path to fairer liver transplants

first_imgThe problem is that some parts of the country have fewer available organs, and higher demand for them, than others. That means someone in California or New York, among the toughest places to get a new liver, tends to be sicker before getting a transplant than someone in South Carolina or Washington state. By Associated Press Aug. 15, 2016 Reprints Related: The transplant chief at a leading liver center welcomed the proposed change.“The distribution of organs is not a right, it’s a gift. We want to try to allocate that gift in the most fair way possible, the way that does the greatest good,” said Dr. Abhinav Humar of the University of Pittsburgh Medical Center, who isn’t part of the UNOS committee.Because a piece of a liver can regrow, patients can avoid the transplant wait if they’re able to find a living donor, he noted. But ultimately, more organs from deceased donors are needed.With the proposed remapping, “we’re just changing the way the pie is distributed,” Humar said. “The best solution would still be to make the pie bigger.”— Lauran Neergaard Related: About the Author Reprints Matching hearts — and kidneys and lungs. This website makes organ transplants in the US possible Tags organ transplant UNOS’ proposed fix is similar to how politicians redraw voting maps: divide the nation into eight new “districts” for liver transplants. That allows wider sharing and shifts the boundaries to better mix areas where more potential donors live with areas that have longer waiting lists.The goal is for patients to have similar MELD scores at the time of transplant no matter where they live. Research models suggested the change would mean the less sick in some places, such as in the South and Northwest, would wait a little longer so that sicker people elsewhere can get a new organ a little sooner.UNOS has debated how to change liver distribution for several years, a process Hirose called contentious as some transplant centers with shorter waits didn’t want to lose them. The proposal will be open for comment from the public — check https://optn.transplant.hrsa.gov/ — through mid-October before any changes are finalized.Sick patients shouldn’t have to leave home to improve their odds of a transplant, said liver recipient Myles Kane. He was shocked when his own doctors in New York urged the Brooklyn man to explore that option after an autoimmune disease caused his liver to fail at age 33.“There’s this magical window where you have to be the sickest person on the list, but if you die from that sickness — it’s a real narrow window,” said Kane, who eventually got on a shorter waiting list in North Carolina, where his girlfriend’s parents lived.They gave Kane a place to stay for three months while recuperating from his December 2013 transplant; he met other patients who had to spend months in hotels. “There’s a huge difference in the risk of death on that waiting list depending on where you live,” said Hirose, a transplant surgeon at the University of California, San Francisco. Shifting the boundaries that determine where a liver is offered first “matches better the organ supply and demand.”advertisementcenter_img Hospitals are throwing out organs and denying transplants to meet federal standards More than 14,600 people are on the waiting list for a new liver. Just over 7,100 received one last year — all but a few hundred from deceased donors — and more than 1,400 people died waiting.The geographic disparity adds another hurdle.Livers are offered first to the sickest patients as determined by a ranking, a so-called MELD score, which uses laboratory tests to predict their current risk of death. The nation’s 11 transplant regions are subdivided into local areas with individual waiting lists, and there are wide variations in organ availability both within and between regions.Today, some regions are able to transplant patients before they’re super-sick — with MELD scores as low as 23 — while others can’t provide transplants until a patient’s MELD score reaches 35, meaning they’re at risk of death within weeks, Hirose said.It’s legal to move around for a better chance, if people know that and are able to. For example, the late Apple CEO Steve Jobs lived in California but in 2009 had a transplant in Tennessee, which at the time had one of the shortest waits. HealthOrgan network mapping a path to fairer liver transplants WASHINGTON — The nation’s transplant network is taking a long-awaited step to ease a serious disparity: Where you live affects whether you get a timely liver transplant or die waiting.Desperate patients sometimes travel across the country to get on a shorter waiting list — if they can afford it. On Monday, the United Network for Organ Sharing is proposing a change, redrawing the map that governs how donated livers are distributed so patients wouldn’t need to leave home for better odds.“We want to make sure we give everyone a fair opportunity to get a liver transplant,” said Dr. Ryutaro Hirose, chairman of the liver transplant committee at UNOS, which runs the nation’s transplant system. “It’s pretty much long overdue.”advertisement White House announces new Pentagon effort to improve organ transplants Molly Riley/AP Associated Press Related:last_img read more

Pulled by different forces, women in medicine need to stand by their career and family choices

first_img @sarah_c_bauer Angira Patel Leave this field empty if you’re human: Women are judged if they take off too much time from work. They are also chastised if they don’t take enough time off. Take the case of Marissa Meyer, the CEO of Yahoo, who was criticized in the media this spring for not taking an “appropriate” amount of maternity leave and returning too soon to her high-powered position.To be sure, women have made significant strides toward equality in medicine. Men also struggle with balancing their roles as parents and physicians. Navigating work and life is difficult for women and for men. Both make personal decisions to leave medicine or decrease the time they spend practicing it for many reasons, and these reasons are right for them. Perhaps one legacy of the women’s movement is the opportunity to choose the way we construct our lives with work and family.These choices create a new reality for women that is an amalgamation of work and personal lives, not an either-or-all phenomenon. Just as the practice of medicine involves making difficult choices when clinical outcomes are uncertain, so does the emerging picture of what women can be in medicine.Women should be told early that they will need to make sacrifices in every part of their lives to create that elusive balance. And that’s okay. It doesn’t mean you are doing something wrong, but doing something necessary.Women’s lives have their own developmental stages. Some are about our careers, others are about caring for others. Some life stages are about both of these at the same time. We should have the freedom to choose and not fight ourselves when moving from one to another or deciding to stay put. Related: Women demand more clout in biotech. First step? Take charge of the money Women won the majority of the U.S. medals at the Rio Olympics. Hillary Clinton is campaigning hard to become the country’s first female president. This may suggest that we have finally arrived at the mythical finish line and “having it all” goal of the feminist movement. Even President Obama, a father of two girls, had something to add to the conversation in his recent article, “This is What A Feminist Looks Like”.But it doesn’t feel as if we have arrived or that the proverbial glass ceiling has been shattered. The role of women at home and work remains highly politicized and steeped in stereotypes. This tension plays out in a unique way in academic medicine, particularly pediatrics, where women comprise more than 57 percent of pediatricians and 70 percent of pediatric residents.Despite their numbers, women hold a minority of leadership positions. Across all academic fields, 14 percent of department chairs are female. In pediatrics, with a higher percentage of female physicians, only 25 percent are female. Access to medical school isn’t the problem. Women now comprise 48 percent of medical school students in the United States.advertisement Sarah C. Bauer As a pediatric cardiologist and a developmental pediatrician who are both interested in academic medicine, we believe that all of these contribute to the problem.advertisement We were raised by mothers and grandmothers who encouraged us to believe we could be whatever we wanted and could “do it all.” We benefit from the sacrifices of women who came before us and fought for equal rights at home and at work.As we progress in our careers and personal lives, though, the reality of what we are experiencing is at odds with the messages of prior generations. Today’s messages for women — in what they read and in their daily interactions at work — are muddled, full of judgment, and confusing.Female physicians “can’t have it all,” Dr. Karen Siebert once wrote in the New York Times. “Medicine shouldn’t be a part-time interest to be set aside if it becomes inconvenient; it deserves to be a life’s work,” she claimed. We (and those who have supported us along the way) voluntarily make emotional, physical, and financial sacrifices to become physicians. But we may also choose to take a step back to raise families. Neither are insignificant decisions. But it shouldn’t be one that is judged — implicitly or explicitly — by others who don’t understand each person’s individual journey.Anne-Marie Slaughter generated a national conversation about this phenomenon in her 2012 essay in the Atlantic, in which she describes the journey of raising a teenager while maintaining a demanding position as the first female director of policy planning in the US State Department. She argued that equal opportunity for women at work does not exist. In fact, it cannot exist without significant policy changes that support work-life balance. First OpinionPulled by different forces, women in medicine need to stand by their career and family choices APStock By Angira Patel and Sarah C. Bauer Sept. 1, 2016 Reprintscenter_img Experts have attributed this inequality to a variety of factors. These include a voluntary withdrawal from medicine (including academic medicine) or leadership positions, inherent power differentials and stereotypes that lead to decreased opportunities for leadership, and biological factors and responsibilities at home that foster the perception of decreased dedication. Women are entering academic medicine, but they are not staying long enough to reach leadership positions. Related: Fighting the silent crisis of physician burnout Newsletters Sign up for Weekend Reads Our top picks for great reads, delivered to your inbox each weekend. About the Authors Reprints Privacy Policy Most of all we need to stand behind our choices — to work, to stay at home, to have a family, to not have a family, to do both — and not be saddled with regret or anguish. Supporting one another in executing these choices should be the next mission of women in medicine, and the workplace in general. Only with this frame of mind and an open honest dialogue can we address the existing dearth of inequalities and female leadership in medicine and encourage women to stay in the game.Angira Patel, MD, is a pediatric cardiologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, and assistant professor of pediatrics and medical education at Northwestern University Feinberg School of Medicine. Sarah C. Bauer, MD, is a developmental pediatrician at Lurie Children’s Hospital and assistant professor of pediatrics at Northwestern. [email protected] Please enter a valid email address. Tags medicinepediatricswomenlast_img read more

Up and down the ladder: The latest comings and goings

first_imgPharmalot @Pharmalot About the Author Reprints GET STARTED Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Tags jobspharmaceuticalsSTAT+ What is it? By Ed Silverman March 17, 2017 Reprints 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?center_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Hired someone new and exciting? Promoting a rising star? Finally solved that hard-to-fill spot?Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. Alex Hogan/STAT Ed Silverman [email protected] Log In | Learn More Up and down the ladder: The latest comings and goings last_img read more

What it’s like to be a Hollywood director making an ad for Pfizer

first_img 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. Tags pharmaceuticalsSTAT+ Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED A sample image from Stromberg’s Pfizer ad. Courtesy Pfizer Pharma What it’s like to be a Hollywood director making an ad for Pfizer By Rebecca Robbins Sept. 15, 2017 Reprints GET STARTED 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. If Pfizer’s latest ad looks to you like a visual effects-heavy Hollywood film, it’s by design.The beaming couples and natural landscapes typical of pharma ads have been replaced by dreamlike scenes of a giant sailing ship, a launching rocket, and twin-sized beds flapping their wings through the clouds. And no, Pfizer (PFE) wouldn’t disclose the ad’s budget. What is it? Log In | Learn More last_img read more

Maine OKs Medicaid expansion in first-of-its-kind referendum

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. By Associated Press Nov. 8, 2017 Reprints Log In | Learn More Associated Press 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. Politics What is it? Tags policy About the Author Reprints What’s included? GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED PORTLAND, Maine — Residents in this rural state grappling with a heroin epidemic and an aging population voted Tuesday to deliver a rebuke to Republican Gov. Paul LePage and join 31 other states that have expanded Medicaid under former President Barack Obama’s health care law.The referendum represents the first time since the law took effect that the question of expansion had been put in front of U.S. voters. Supporters of Medicaid expansion celebrate their victory, Tuesday, Nov. 7, 2017, in Portland, Maine. Robert F. Bukaty/AP Maine OKs Medicaid expansion in first-of-its-kind referendum last_img read more

Let #MeToo be a catalyst towards removing gender bias in STEM

first_img Karin Lachmi Related: The most severe cases of harassment I’ve lived through, in both the business and research setting, are especially difficult for me to share publicly. But I have come to accept that the discomfort in thinking about and sharing these experiences is also the imperative for me to share.I once received an invitation from a prominent Sand Hill Road venture capitalist to join him in a Jacuzzi for a “meeting.” I have been inexplicably and unexpectedly forced to kiss an investor in the middle of a business meeting.As a researcher, I encountered sexual harassment at the critical and final stage of securing my Ph.D. — my search for a principal investigator. After identifying the top experts in my field, I secured a meeting with a highly respected professor. It was the equivalent of a budding musician meeting her lifelong idol. I was starstruck, and spent days preparing my research ideas. But as I gave him an overview of my dissertation, I realized the meeting was taking a turn for the worse. The professor, a male who, to my knowledge, is still a professor, was conducting a head-to-toe scan of my body and coyly smiling. I stopped mid-conversation to address this uncomfortable situation. He chuckled and unabashedly said, “Sorry, but if I must be honest, you are just much more intelligent than you look.” About the Author Reprints Leave this field empty if you’re human: Looking back on that episode, I want to believe that if the same thing happened to me today I would speak up and even report him. But at the time I didn’t do that. While I ultimately found another principal investigator, secured my Ph.D., and continued my professional development in the field, the same might not be true of other young women at a similar, or worse, crossroad.While this scenario could, of course, still happen in an environment where more women are in positions of authority (women are not the only victims of sexual harassment, as we saw recently in the Kevin Spacey scandal), perhaps it would be the rare exception instead of an all-too-familiar story. The U.S. Equal Employment Opportunity Commission found that significant power disparities between men and women in the workplace is a top risk factor for harassment. This harassment can, in turn, further perpetuate the status quo, making the respective field that much more challenging for a woman to succeed in, advance in, or enter to begin with. This, of course, extends beyond STEM.But STEM is a field grounded in facts, hard data, and repetition. We’ve “repeated” enough tests, surveys, and studies of gender bias and sexual harassment, and we’ve reviewed the data. Now it’s time to take this moment to actively carve a path forward and join other industries in rooting out gender-based workplace harassment. Related: Privacy Policy Sadly, I know that my female peers on both the research and business sides of STEM don’t find these statistics surprising, as many of us have experienced some form of bias, discrimination, or harassment during our careers. For me, it sometimes comes in the form of what appear to be “minor” incidents — whether it is being questioned on my professionalism or having business conversations directed solely towards my male colleagues. Then there are the cases where my ideas and decisions are ignored when I share them, but they are enthusiastically accepted when they come from a man. I’ve been frequently interrupted and talked over (mansplaining). Sometimes in emails where I am very obviously a contributing member to the discussion, I have had colleagues treat me as a scheduling administrator because I was the only female name on the thread.advertisement BERTRAND GUAY/AFP/Getty Images From a leadership perspective, companies and academic institutions large and small across STEM need to commit to “50 Percent in All” — equal representation of women on management teams, boards of directors, and all decision-making committees. To reach a point where this is possible, all executives in power today must leverage their positions of authority to find, discover, and cultivate talented women for leadership positions.Similarly, women who are advancing in their careers and research need to rise up. Take comfort and courage from the brave stories of the women who’ve shared their #MeToo story. Speak up, reach out (and up), and seek all opportunities for growth early and often. If we approach this from both ends and apply the rigor and mindset of STEM disciplines to the drive to bring about change, STEM can be a driving force in addressing gender equality.Karin Lachmi, Ph.D., is co-founder, chief scientific officer, and president of Bioz. She previously served as managing director of the western region of the Tel Aviv Sourasky Medical Center U.S. Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts.center_img The now-viral #MeToo social campaign has been tweeted about nearly 2 million times by men and women in 85 countries, leaving me with a sense of hope — and one of frustration. These posts are often accompanied by stories of encounters that range from gross to humiliating to horrific.The campaign has untied years of silence for thousands of women who were sexually harassed but kept quiet, and silence by women and men who knew what was occurring but did nothing about it. It has become a blunt indictment of the sexual balance of power that exists today between men and women in the Western world.As a woman in science, technology, engineering, and mathematics (STEM) and a biotech entrepreneur, I have seen and experienced firsthand the challenges and struggles that women in male-dominated professions face every day. But while there is no overnight fix in any industry or sector, I believe the STEM industries play a critical role in the path to removing gender biases and sexual harassment in the workplace.advertisement The data and research on implicit biases and the discrimination that affects women in STEM are well-documented. For example, a study published in the Journal of the American Medical Association found that two-thirds of women in biomedical research have personally experienced “gender bias in professional advancement,” and one-third have experienced sexual harassment. Furthermore, STEM had its own “Harvey Weinstein” moment just over a year ago with Geoffrey Marcy, a well-known astronomer at the University of California, Berkeley. Female scientists face gender bias in NIH grant process Please enter a valid email address. By Karin Lachmi Nov. 8, 2017 Reprints First OpinionLet #MeToo be a catalyst towards removing gender bias in STEM [email protected] Female scientists report pervasive gender bias, sexual harassment Tags advocacybiotechnologywomen’s healthlast_img read more

NIH and opioid response get boost in Senate budget deal

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Tags Congressopioidspolicy Lev Facher GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Politics By Lev Facher Feb. 7, 2018 Reprints What is it? Washington Correspondent Lev Facher covers the politics of health and life sciences. WASHINGTON — Senate leaders on Wednesday announced a bipartisan budget agreement that would increase funding for the National Institutes of Health by $2 billion and raise spending meant to address the opioid and mental health crisis by $6 billion over the next two years.The White House endorsed the agreement during its announcement on the Senate floor. The House is likely to pass it with few changes, staving off another government shutdown or continuing spending resolution that had loomed if no agreement was reached.center_img @levfacher Lydia Polimeni/NIH Log In | Learn More 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. NIH and opioid response get boost in Senate budget deal [email protected] About the Author Reprintslast_img read more