Month: June 2021

New research could make safer polio vaccine, critical for eradication, a reality

first_img Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Related: In the LabNew research could make safer polio vaccine, critical for eradication, a reality WHO advisers say first malaria vaccine needs more real-world study @HelenBranswell Helen Branswell Polio has been brought to the brink of extinction by two vaccines designed in the 1950s by American scientific giants Jonas Salk and Albert Sabin. The polio eradication campaign, which began in 1988, has succeeded in halting spread of polioviruses in all but two countries, Pakistan and Afghanistan.The vaccines have prevented millions of people the world over from being paralyzed by polioviruses. But for all their history-changing benefits, both vaccines come with significant drawbacks. And even if polio transmissions can be stopped by sometime in 2016, as many hope, the world will continue to need a safe vaccine, potentially for decades to come.advertisement Workers in Buckinghamshire prepare a vaccine based on killed poliovirus in 1956. Fox Photos/Getty Images A polio milestone: One strain left in the crosshairs Related: British scientists say they have developed new viruses to serve as the basis for a safer polio vaccine, a much-needed tool as the world nears the eradication of the disease.While more research is needed to see if the vaccine strains are safe and effective in people, those involved in the polio eradication effort cheered the report, published Thursday in the journal PLOS Pathogens.“I’m impressed. I didn’t expect this to happen, certainly this quickly,” said Dr. Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health in Baltimore. Halsey was not involved in the research, but serves on a World Health Organization polio research committee with the senior author of the study.advertisement The vaccine viruses engineered by the British team, led by veteran polio researcher Philip Minor, will be safer than wild polioviruses, because like Sabin’s vaccine viruses, they are weakened. But unlike Sabin’s versions, the new vaccine viruses can be used in killed form, so there is no concern they will paralyze the immediate recipient. Nor can killed viruses spread from child to child, regaining virulence.“This is a very important step in terms of trying to have viruses that can be used to produce vaccine without any risk of those viruses causing outbreaks of polio,” Halsey said. He and others noted, though, that more work needs to be done to prove that the new vaccine viruses will deliver on their promise when used by people.And it remains to be seen if the vaccine viruses will actually ever be produced, experts acknowledged.Polio eradication program leaders hope that 2016 will be the year when polio transmission finally stops. Cessation of transmission would be followed by a three-year certification period, in which heightened surveillance would tell the world whether polio was truly gone. If no additional cases were seen, polio could be declared eradicated in 2019.The Global Polio Eradication Initiative’s strategic plan says countries should continue to use the polio vaccine — and it will have to be the killed virus vaccine — for at least five years after eradication is completed. Developed countries are unlikely to stop vaccinating for years, maybe decades. But some countries with limited health budgets and multiple health problems will want to stop vaccinating when it’s considered safe, Dowdle said.So will manufacturers take on the substantial expense of testing and licensing a wholly new polio vaccine for a market that is bound to start shrinking? Even if all goes well with these vaccine viruses, it could be a decade before a vaccine containing them is ready for use.This is a critical issue, admitted Dr. Walter Orenstein, associate director of the Emory Vaccine Center at Atlanta’s Emory University and a consultant on polio for the Bill and Melinda Gates Foundation.“If this is going to be a viable tool, there needs to be a commercial incentive for use,” he said. “Would a five-year use be adequate commercial incentive to go through all of the development phases?” There has been a concerted effort to find a better, safer vaccine, but that goal has been elusive.Scientists at Britain’s National Institute for Biological Standards and Control, however, reported they have engineered polioviruses that could be used in a next-generation vaccine that would solve the problems of Sabin’s oral polio drops and the risks associated with production of Salk’s injectable vaccine, known in the polio world as OPV and IPV, respectively.The British team, funded by Britain’s Department of Health, reported it has managed to modify Sabin’s vaccine viruses so that they could be used in an inactivated vaccine, one in which the virus has been essentially killed. In animal testing, the new vaccine viruses appeared to generate a protective immune response. By Helen Branswell Dec. 31, 2015 Reprints About the Author Reprints Related: “It’s really a step in the right direction. They’ve done a nice job,” said Walter Dowdle, a former deputy director of the Centers for Disease Control and Prevention and a member of a working group that advises the WHO on polio vaccine issues.It has long been understood that neither of the existing vaccines is an ideal option for use when polio transmission has stopped.Sabin’s oral vaccine, made with weakened polio strains, will on rare occasions paralyze a child who takes the vaccine drops. The WHO estimates that for every group of a million children getting multiple doses of oral vaccine, between two and four will develop polio paralysis from it.The oral vaccine poses another, more serious problem. Vaccinated children discharge the live, weakened vaccine viruses in their stool. Those vaccine viruses get into the environment, finding their way into other children. As they pass from one to the next, they can lose the mutations that weakened them, regaining the paralytic power of regular polioviruses.At this point, more children are actually being paralyzed by vaccine viruses than by wild polioviruses. The Global Polio Eradication Initiative says that in 2015, 70 children were paralyzed by polio but 213 were paralyzed by vaccine viruses that regained virulence.When polio cases numbered in the tens of thousands, the oral vaccine risks were outweighed by the vaccine’s considerable benefits. But it is clear polio will never fully vanish as long as oral polio vaccines are in use, and those vaccines will be phased out when transmission stops.At the individual level, the injectable vaccine created by Salk is safer, though its higher cost and the need to have it delivered by a health provider have for the most part put it out of reach of many developing countries. (Oral polio drops can be given by anyone with a moderate amount of training.)But production of the injectable vaccine poses its own risks, which will become even greater once polio transmission ceases. To make the vaccine, manufacturers must generate large volumes of polioviruses — and these are not the weakened versions — which are eventually killed and formulated into vaccine.If a production plant had an accidental leak, the results could be disastrous — especially if it were to happen in a country where polio vaccination efforts had lagged and large numbers of children were not protected against polio. That’s not just a theoretical threat; a GSK production facility in Rixensart, Belgium, accidentally released 11 gallons of solution containing live polioviruses into nearby waterways in 2013.It is also feared these supplies of virulent polioviruses could be targets for would-be bioterrorists. 3 stories to watch in global health in 2016 Tags global healthpolioVaccineslast_img read more

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Obama administration wants $1 billion to jumpstart Joe Biden’s cancer ‘moonshot’

first_img Related: Related: Vice President Joe Biden’s cancer effort will get a big boost from President Barack Obama’s final budget, which comes out next week. Jacquelyn Martin/AP As part of this funding “jumpstart,” Obama will also request a new funding stream, called the Exceptional Opportunities in Cancer Research Fund, which will direct money to “out-of-the-box” research that previously struggled to receive federal grants. The administration officials declined to be more specific about what kind of research would be the target of that funding, saying more information would be available soon.The National Cancer Moonshot, as the White House has begun to call it, will focus on six areas, according to administration officials: early-detection technology, cancer vaccines, immunotherapy, genomic analysis of tumors, enhanced data sharing, and pediatric cancer.The funding announcement comes the same day that Biden will convene a meeting of his new federal cancer task force created. Obama will be at the meeting, and top officials from the Department of Health and Human Services, Defense Department, VA, NIH, and FDA are expected to be in attendance.Along with its research and data goals, the task force will focus on trying to expand access to clinical trials, which only 5 percent of cancer patients currently participate in, one official said. The medical education of Joe Biden: a serious listening tour with vague goals “We believe that starting the moonshot now will allow us to capitalize on recent great strides in the cancer research area,” one official said.For the current fiscal year, the National Cancer Institute has a $5.2 billion budget, while NIH as a whole has a $32 billion budget. Both saw significant increases in the spending bill signed by Obama in December.Congress must approve the president’s funding request before the money could actually be spent. White House press secretary Josh Earnest said Obama will make his pitch for the funding at a meeting Tuesday with House Speaker Paul Ryan and Senate Majority Leader Mitch McConnell. There will also be increased spending on cancer programs at the Departments of Defense and Veterans Affairs, which will boost longitudinal research into risks factors for cancer and new treatments.The overall goal being set by the administration, officials said, is to achieve a decade’s worth of advances in five years. The officials declined to be specific about how that progress would be measured, saying more information would be given in the coming weeks.advertisement WASHINGTON — The Obama administration is aiming to spend $1 billion to jumpstart the cancer moonshot being led by Vice President Joe Biden, senior administration officials said Monday.Some of that money has already been appropriated in the federal spending bill that President Barack Obama signed in December, the officials told reporters on a conference call. Nearly $200 million in new funding from the omnibus bill, directed to the National Institutes of Health, will be spent on new cancer initiatives, they said.In his final budget proposal, to be released Feb. 9, Obama will then request another $755 million for the next fiscal year to pursue a multi-year moonshot initiative, officials said. The vast majority would go toward the NIH, while $75 million would be earmarked for data work at the Food and Drug Administration.advertisement Biden has said that the cancer task force would allow him to use “every federal agency at my disposal” in the moonshot. He has pledged to figure out ways to make the federal government “partners, not impediments” in progressing toward breakthrough treatments.The task force’s first meeting, which is closed to the public, will be held in the vice president’s office. Leading up to that launch, Biden has met with upwards of 200 cancer researchers and advocates since October, according to his aides.Biden urged a “national commitment to end cancer” when he announced in the fall that he would not run for president. Obama endorsed the moonshot in his State of the Union address last month and placed Biden in charge of it.Sheila Kaplan contributed to this report.This story has been updated with comments from White House press secretary Josh Earnest. A presidential cancer moonshot (again)Volume 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/2016/02/01/biden-cancer-moonshot-budget/?jwsource=clCopied EmbedCopiedLive00:0001:1001:10  Presidents have been promising to cure cancer for 45 years, but cancer is still very much with us. Alex Hogan/STAT Joe Biden urges ‘more tax dollars, a lot more cooperation’ for cancer moonshot By Dylan Scott Feb. 1, 2016 Reprints PoliticsObama administration wants $1 billion to jumpstart Joe Biden’s cancer ‘moonshot’ State of the Union 2016: Obama endorses Biden’s cancer research ‘moonshot’ Related: Tags cancerJoe Bidenmoonshotpolicylast_img read more

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White House will dip into Ebola funding to fight Zika, possibly ending impasse

first_imgAnd in an interview with STAT last month, Representative Tom Cole, the chairman of the House Appropriations subcommittee that funds health programs, suggested that Congress could “backfill” any Ebola money that the administration had to spend now by replacing it in the next regular funding bill. He also didn’t rule out a smaller emergency funding bill once Republicans are convinced the administration has spent all of the money it already has on hand.In a letter Tuesday to Republican and Democratic leaders, more than 60 public health and medical groups urged Congress to approve the emergency Zika money — though they also said lawmakers should “provide new funding rather than repurpose money from other high priority programs.” PoliticsWhite House will dip into Ebola funding to fight Zika, possibly ending impasse WASHINGTON — The Obama administration plans to spend unused Ebola funds to fight the Zika virus, a breakthrough that could ease the standoff with Congress over the administration’s request for emergency money for the crisis.The administration will jump-start the Zika effort using leftover money that Congress had given the health agencies to fight the Ebola outbreak in West Africa, according to two congressional sources. The biggest amount of unused money is $600 million that was intended to help 30 countries improve, and in some cases build, public health systems to make them better prepared to fight future infectious diseases.The move, first reported by the Associated Press, could make it easier to negotiate with congressional Republicans over the rest of the Zika package. The Obama administration had asked for $1.9 billion in emergency funds to fight the spread of the virus, but top House Republicans pushed back, saying the administration should first use any money Congress has already provided for Ebola that hasn’t been spent.advertisement Related: By David Nather and Dylan Scott April 5, 2016 Reprints Clinton and top Democrats demand Congress approve Zika funds The move could ease the deadlock between the White House and Congress over Zika funds. Pete Souza/White House That response led to a series of urgent warnings from federal health officials, who said agencies like the Centers for Disease Control and Prevention were desperately shifting money away from other vital health programs to buy time until Congress agreed to pay for a robust Zika response.Despite the public deadlock, though, there have already been signs of flexibility. White House press secretary Josh Earnest even hinted at such a move in a February briefing, in which he noted that “there may be a point in time in which we feel like there are some resources from our Ebola efforts that could be used for other things without impacting our critical efforts against Ebola.”advertisement Tags CDCCongresspolicyZika Viruslast_img read more

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Disney, fearing a scandal, tried to press journal to withdraw research paper

first_img Please enter a valid email address. Tags academic publishingDisneymedical research Leave this field empty if you’re human: The study, published in the Journal of the Association for Consumer Research, was a retrospective analysis of kids’ meals sold at Disney World.The authors looked at data from all 145 Disney World restaurants since it revamped its children’s menus to offer healthier default choices. In the new model, parents who want to order soda or fries for their kids — instead of choices like low-fat milk, fruit, or carrots — have to ask for them.The study found that nearly half the meals ordered for the children included the healthy default side dishes and two-thirds included the healthier drinks.The authors wrote that these choices resulted in significant reductions in calories, fat, and sodium in the kids’ meals, but not sugar.After the study was accepted by the journal, Disney asked the authors not to publish it. The editor, Brian Wansink, a Cornell University professor who edited the issue, told the authors it was too late to pull it.Wansink “advised me confidentially that it is considered unethical for sponsors of research to have input into publication issues,” Hill wrote to Disney in an email.A Disney spokesman acknowledged the effort.“Given the recent issues regarding Dr. Hill and the university, we questioned the wisdom of publishing the study,” said David Jefferson, a Disney spokesman. HealthDisney, fearing a scandal, tried to press journal to withdraw research paper Alex Hogan/STAT, APStock Related: The Walt Disney Company urged an academic journal to withdraw a nutritional study of children’s meals at Disney World last fall — a study it had funded — amid a public backlash over corporate involvement in scientific research, according to newly obtained emails.Disney wasn’t concerned about the study’s findings, but feared being publicly associated with one of its main authors, James Hill of the University of Colorado School of Medicine. Hill’s work last summer drew an outcry among scientists who felt his project, funded by Coca-Cola, played down the impact of sugary drinks in obesity.Emails obtained by STAT show that Disney asked Hill and a coauthor to withdraw the meal study — a step that many researchers would consider a breach of ethics.advertisement Privacy Policy Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day.center_img One of the lead authors of the study, John Peters, also a professor at the University of Colorado School of Medicine, said in an interview that the study was a legitimate subject of research, adding that no one had yet examined whether Disney’s approach was effective in providing families with healthier meals. Asked about Disney’s attempt to withdraw the study, he said the company had “never sponsored any research before and they were not really familiar with the rules of doing so.”Peters said he was worried about negative publicity surrounding industry-sponsored studies, which he believes can be unbiased if ethics guidelines are followed.“It’s kind of a shame this sort of scrutiny on industry-sponsored research can have unintended consequences — maybe scaring people off to say, ‘I don’t ever want to fund research as an industry because it’s not worth it,’” he said.Gary Ruskin, codirector of US Right to Know, a California-based consumer group that obtained the emails under the Colorado Open Records Act and provided them to STAT, said he was troubled by the authors’ disclosure on the paper.That disclosure said, “The Walt Disney Company and the National Institutes of Health,” which also contributed funding, “had no role in the design, analysis or writing of this article.”It suggests Disney shouldn’t have had the opportunity to edit the press release, Ruskin said. But the emails show Disney insisting on more information about the publication before they could give approval to a press release; the authors then provided Disney with the draft release.“I drafted a simple release … but we can edit to our hearts content,” Peters wrote.“It’s dishonest to disclose in their paper that Disney has no impact when Disney gets to approve the news release and when they do Disney’s bidding to try to take the paper back,” Ruskin said.In an email, Hill defended the work by Peters and his other coauthors, saying he was “happy the scientific community was able to learn about the good work with food that Disney is doing in their parks.”“I am sorry that companies like Disney have to worry about negative PR from funding research,” he added. “We need more, not less, research.” “The authors should follow the science, and Disney should not be influencing either how they do the study, how they report the study, or whether they report the study,” said George Annas, a Boston University professor of law and medicine who also directs the Center for Health Law, Ethics & Human Rights. “There can’t be any strings attached.” “The authors should follow the science, and Disney should not be influencing either how they do the study, how they report the study, or whether they report the study.” In one email, Hill told Disney an editor at the journal had advised him that “we risk some real negative PR if anyone found out that Disney was even trying to influence publication.” The company relented, but was later offered an opportunity by the authors to tailor the press release about the study’s findings. That, too, was unusual.The emails do not indicate that Disney influenced the findings, but they open a rare window on the back-and-forth between researchers and a corporate sponsor. They also mark what experts described as an unusual degree of corporate involvement in an academic study.advertisement George Annas, Boston University More people on Earth now obese than underweight By Sheila Kaplan April 8, 2016 Reprintslast_img read more

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Donald Trump’s trade talk is making the drug industry uneasy

first_imgPoliticsDonald Trump’s trade talk is making the drug industry uneasy By Dylan Scott Aug. 18, 2016 Reprints The Trump campaign isn’t providing any clarity for now. Two campaign aides did not respond to multiple requests for comment on the issue.Despite its disquiet, the drug industry hasn’t been publicly opposing Trump on the trade issue. Several lobbyists demurred when asked about it, and the industry groups in Washington declined to comment on the record.That’s another part of the Trump riddle that the entire health care apparatus in Washington is trying to solve: How openly should they challenge a candidate hardwired for controversy and inflammatory rhetoric?Trade is a prime example. The industry feels strongly about it, but fears that going toe to toe with Trump would “inflame the beast,” as Mendelson put it.“They really don’t know just how threatening this would be if he were president,” he said. “Every health care group in Washington is feeling very ginger about picking its battles. If you criticize him, you make yourself the subject of his ire.” WASHINGTON — The drug industry is quietly troubled over Donald Trump’s tough talk on trade.The Republican presidential nominee has promised to aggressively renegotiate America’s trade deals — and to tear them up if need be. Those pledges are now rankling a biopharmaceutical sector that depends heavily on the deals to protect their intellectual property and, by extension, their entire business model.Provisions in the deals typically require participating nations to adhere to patent protections similar to those in the United States, to give companies relief if there is a delay in granting a patent, and to keep their clinical data confidential.advertisement Trump isn’t directly attacking the drug companies, as have Hillary Clinton and other Democrats on the campaign trail. But the industry is nonetheless concerned about his stance on trade, one of the issues where he seems substantively engaged.advertisement Ira Loss, executive vice president and senior health care analyst at Washington Analysis, a consulting firm that follows the drug industry and regulatory policy, said in an email that drug makers are “certainly not happy about [Trump’s] plans to undo trade deals that have advantaged the industry.”Others inside the industry, who requested anonymity to speak candidly, said they worry because Trump hasn’t specified how he would like to see US trade deals changed.The United States is a party to dozens of trade agreements with individual countries, as well as broader pacts like the North American Free Trade Agreement and the Trans-Pacific Partnership, the latter of which has not yet been ratified by Congress. Trump has directed much of his criticism at NAFTA and TPP specifically.Adding to the industry’s uneasiness is the promise it sees in developing nations as emerging new markets that will help sustain their business. Last year, IMS Health estimated that those countries would account for nearly half of the growth in global drug spending in 2018.That makes free trade agreements and their accompanying protections all the more important for pharma.“If the intent of it is to say trade agreements need to do a better job of ensuring US industries are not ripped off and taken advantage of by foreigners — which is kind of the way that Trump puts it — then arguably that’s not bad,” one industry official said. “But what I think it really means is these people just aren’t in favor of trade agreements.” Supreme Court’s ruling in patent case a blow to drug industry “These trade deals are lifeblood for the protections of the intellectual property that pharma maintains,” said Dan Mendelson, president of Avalere Health, a consulting firm that works with life-sciences companies. “When you start going in and saying we’re going to rip these up, you upset the balance.” Related: Related: Republican health care experts dismiss ‘buffoon’ Trump’s ideas Tags Donald Trumppharmaceutical industrypolicyPresidential campaign Mark Makela/Getty Imageslast_img read more

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As a stealthy liver disease becomes more common, the search for treatments accelerates

first_imgHealth As a stealthy liver disease becomes more common, the search for treatments accelerates Wayne Eskridge, at his home in Boise, Idaho, has been diagnosed with NASH, an increasingly common liver disease. Kyle Green for STAT By Allison Bond Oct. 6, 2016 Reprints What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. 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. Allison Bond Wayne Eskridge knew he was carrying a few extra pounds, but he still considered himself a pretty healthy guy. When the then-68-year-old electrical engineer underwent gallbladder surgery in 2010, though, his surgeon noticed that Eskridge’s liver didn’t look quite right.That spurred blood tests — it turned out his liver numbers were a little high — and then a referral to a liver specialist and two biopsies. The diagnosis felt like a death sentence: He had cirrhosis. His liver had become shrunken, knobby, and scarred, and would never heal; ultimately, the only treatment would be a liver transplant. About the Author Reprints Tags liver diseaseorgan transplantSTAT+ What’s included? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More @AllisonRBond [email protected] GET STARTEDlast_img read more

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‘Death with dignity’ measure in Colorado stirs controversy — and passion

first_img @judith_graham Palliative care and hospice care are the answer, not assisted suicide, Rastrelli said. Yet these services are not widely available outside metropolitan areas in Colorado, research indicates.On the other side of the divide, Dr. David Hibbard of Boulder, who’s board certified in hospice and palliative care, takes professional and personal comfort from the prospect of aid-in-dying.“While a vast majority of patients would benefit from hospice, there are a minority whose suffering can’t be well-addressed,” he said. Sometimes this suffering is physical; sometimes it’s emotional or existential. Addressing this misery is part of his obligation to patients, Hibbard said.Hibbard has a personal stake in the debate, too: Diagnosed with Parkinson’s disease 10 years ago, he uses a cane to walk and can no longer type or write independently. Should the time come when he can’t feed himself, dress himself, use the toilet, or get out of bed, he said he would consider aid-in-dying.“It’s an option I would like to have available,” Hibbard said. “I might not use it, but I would certainly be comforted knowing it was available to me.” At a hospice facility for children, a long goodbye is made a little less lonely Judith Graham By Judith Graham Nov. 4, 2016 Reprints The Catholic Church and other religious groups are fighting back, arguing that it’s “illogical” to for the state to allow some patients to hasten their deaths, even as taxpayers are funding a public health battle against suicide in Colorado.The measure has also drawn fire from disability rights advocates — among them, Carrie Ann Lucas, who has lived for years with a progressive neuromuscular disease that has left her reliant on a wheelchair, a ventilator, and a gastrostomy tube.advertisement That hasn’t happened: Igel, who is 41, recovered well from brain surgery, though she has to pace herself and is often exhausted at the end of the day. She’s cut back on work and started meditating. She prays, and tries to achieve a sense of balance in her life.“I wanted my diagnosis to make me a better person, and to learn lessons from it,” she said, sitting in the kitchen of her airy home in a Denver suburb.As Igel talked about the future, her eyes teared and her golden retriever came over to nuzzle her. She wants to be brave. But she doesn’t know what lies ahead.Ending her life is the last thing Igel wants to do. She has two young daughters she adores, a loving husband, a large circle of friends, and even plans for retirement.“I want to live as fully as I can for as long as I can,” Igel said, “but if I get to a point where I don’t have any quality of life and current medications aren’t keeping me comfortable, after consulting with my family and the people I love, I would consider it.”Aaron and Megan Igel, at home in a suburb of Denver. Judy GrahamIgel has the same type of tumor as Brittany Maynard, an eloquent 29-year-old with terminal cancer who made national headlines when she began speaking out in favor of the right to “death with dignity” in 2014. Later that year, Maynard swallowed a fatal dose of medication.Support for assisted suicide swelled.“After Brittany there was a sea change — a big national conversation,” said Toni Broaddus, acting director of political affairs for Compassion & Choices, a Denver organization advocating for aid-in-dying measures across the country.California voted last year to allow assisted suicide; the new provisions took effect in June. Oregon, Washington, and Vermont have similar laws, and Montana’s Supreme Court has ruled that the practice is legal in that state. Facing life’s end with grace Politics‘Death with dignity’ measure in Colorado stirs controversy — and passion Related: Related:center_img Colorado’s bill closely tracks the groundbreaking “death with dignity” law passed in Oregon in 1994. It applies to mentally competent adults told by two physicians that they have six months or less to live. Before someone can get a lethal prescription, he or she must make two voluntary verbal requests, 15 days apart, and submit a written request signed by two witnesses.Doctors must refer patients to a psychologist or psychiatrist if they suspect depression or other types of mental illness or cognitive impairment. Every case must be reported to state authorities. And coercion is punishable as a felony.Still, opponents say there aren’t enough safeguards to prevent abuse. The Denver Post, the state’s largest newspaper, came out in opposition to Proposition 106, calling it problematic and poorly crafted.The evangelical group Focus on the Family, headquartered in Colorado Springs, also opposes the measure, arguing that patients may be pushed into suicides to save money. “Doctor-assisted suicide is cheaper than treatment, and that’s dangerous in a profit-driven health care system,” Carrie Gordon Earll, the group’s vice president of public policy, said in a statement.Pressure from insurers, health care providers, and family members can be subtle but insidious, said Lucas, who founded Disabled Parent Rights, which provides legal services to parents and children with disabilities.“As disabled people, all the time we get the message that your life isn’t worth living,” she said.In Colorado’s physician community, there is deep division. The Colorado Medical Society surveyed its members in February; 56 percent favored “physician-assisted suicide” while 35 percent were opposed. The margin was tighter among doctors who frequently treat patients with terminal illnesses: 50 percent in favor, 41 percent opposed.The group voted to remain neutral on Proposition 106, but medical societies in Denver, Boulder, and Pueblo chose to endorse the measure.That alarms Dr. Alan Rastrelli, medical director of a Catholic hospice in Denver. “We physicians aren’t doing our job if people are suffering at the end of life. We should embrace the means to relieve suffering, not kill the sufferer,” he said. About the Author Reprints “We should be legislating to protect the most vulnerable people in our population, not putting them at further risk,” Lucas said.Megan Igel never expected she’d be in the thick of this controversy — a vote with the power to shape both her work and her life.A geriatric physician’s assistant, Igel has watched seniors ready to die linger on in hospice care, often for weeks, until at last their bodies shut down.“I wouldn’t want that,” she’s thought many times, abstractly.Then, a year ago, after worsening headaches, Igel was diagnosed with a brain tumor. Surgery has bought her time. But it’s an incurable cancer that will recur. Doctors just can’t say when.Just before the diagnosis, Igel had helped care for a 25-year-old woman with the same type of brain tumor, an astrocytoma. The patient couldn’t talk or walk after surgery. “I told another physician assistant friend, ‘Don’t let me be like [her], wanting to die, trapped in my body, with no quality of life,’” Iger said. Judy is a STAT correspondent based in Denver. My sister made her end-of-life wishes clear. Then dementia took hold Related: DENVER — She wants to live, more than anything. But if her brain tumor returns, Megan Igel wants the freedom to end her life.A state ballot measure here in Colorado could give her a measure of control: It would allow physicians to prescribe a lethal dose of medication to terminally ill adults who request aid in dying.Supporters have raised more than $5 million and a September poll found 70 percent of voters back the measure, which would make Colorado the sixth state to allow assisted suicide. (The Washington, D.C., City Council is expected to approve a similar measure later this month.)advertisement Debbie Ziegler, mother of Brittany Maynard, speaks to the media after California passed a bill to allow terminally ill patients to legally end their lives. A similar measure is on the ballot in Colorado. Carl Costas/AP Tags 2016 electioncancerhospicepolicysuicidelast_img read more

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Beware of doomsday scenarios for health care spending

first_imgFirst OpinionBeware of doomsday scenarios for health care spending Fair pricing activists applauded the news earlier this month that the FDA approved another drug to cure hepatitis C. That this new medicine is cheaper and treats people quicker than the existing hepatitis C drugs goes to show how fast healthy competition can change the outlook on health spending.Not long ago, health economists were promoting a doomsday scenario that the new crop of hepatitis C drugs would break the bank. To be sure, these drugs were a huge advance, offering cures for hepatitis C rather than holding actions against this potentially disabling and even deadly liver disease. But they were expensive, and the costs would be felt over short time frame rather than be spread out over years.Predictably, health care systems struggled to cope with the immediate budget impact, not least because health budgets operate in silos — the hospital budget, medical fees, drug budget, and the like. So there was an outcry about the increase in the pharmaceutical bill, with little acknowledgement of the future benefit of fewer hospital stays and reduced medical costs. Extrapolating the financial impact of these drugs on the basis of initial price and the potential number of patients that could be taking them was vastly exaggerated. Market dynamics came in, prices dropped, and patient numbers did not go up and up.advertisement Privacy Policy Newsletters Sign up for Pharmalot Your daily update on the drug industry. Please enter a valid email address. We certainly spend far more on cancer treatment today than we did 20 years ago but, in return, we have new medicines that have transformed cancer care. Between 1991 and 2014, the death rate from cancer dropped by 25 percent in the United States. This means 2,143,200 fewer cancer deaths occurred than if rates had persisted at the 1991 level. France spends almost five times more on diabetes medicines than it did 20 years ago, but the treatment for patients is like night and day for a much larger number of patients.In comparison, costs for cardiovascular drugs have shrunk dramatically. In Germany, 12 percent of overall drug spending  in 1995 went toward agents for lowering blood pressure or cholesterol; today it is 4 percent of drug spending. This is a significant change, especially since it has accompanied an equally dramatic reduction in deaths from heart disease.The hepatitis C scenario shows how competition among innovative companies can bring costs down while the patent is still valid. The reduction in costs of cholesterol-lowering agents highlights another dynamic that takes effect when patents expire and these effective and therapeutically important medicines become considerably cheaper, often being sold for a few cents per pill. The expiration of drug patents is expected to reduce overall spending in the U.S. $143.5 billion in the next five years.Medical progress clearly has its price, but doomsday scenarios based on simple extrapolations of today’s numbers are out of touch with reality.Thomas B. Cueni is the director general of the International Federation of Pharmaceutical Manufacturers and Associations, which is funded by dues paid by member companies and associations. The opinions expressed here are his own. Related: Inside the $100 million ad blitz for a $1,100-a-pill drug for hepatitis C FDA OKs new drug to treat all forms of hepatitis C [email protected] Take this famous prediction. Back in 1972, the Club of Rome’s book “The Limits to Growth” foretold that natural oil sources would dry up within 20 years and that reliance on fossil fuel was unsustainable. People took the forecast seriously. Yet here we are, 45 years later, knowing that the scenario was wrong, in part because it failed to predict that the United States would become one of the world’s largest oil and gas producers.advertisement Vincento Pinto/AFP/Getty Images I believe that doomsday predictions should carry a health warning because they can mislead policy makers to make wrong decisions. Related: The problem with such doomsday predictions is that they make extrapolations based on static thinking, such as using consumption growth rates and reserves of finite resources known at the time.Looking at today’s debates on health and pharmaceutical policies reminds me of the Club of Rome’s doomsday scenario. Predictions abound, warning that the health system budget is about to explode or that access to innovative medicines is unsustainable.I have been hearing such predictions for more than 20 years. Don’t get me wrong: thinking about the sustainability of our health systems is legitimate, important, and necessary. Demographic trends on the one hand and achievements in biomedical research on the other offer considerable challenges for health systems, even in wealthier countries.But the discussion isn’t really new. In the mid-1990s, the Danish government feared that a highly effective anti-migraine drug would break its health care budget. Based on an extrapolation of the price of the medicine and the potential number of migraine patients, some experts reckoned that the medicine would consume a significant chunk of Danish health care spending, not just pharmaceutical expenses. Such extrapolations were spectacularly wrong, which was fortunate for the Danish health care budget. About the Author Reprints By Thomas B. Cueni Aug. 24, 2017 Reprints Leave this field empty if you’re human: We are having a similar discussion today about the financial consequences of new hepatitis C medicines. These drugs are a demonstration of disruptive innovation at its best.Before these medicines were developed, the heavy cost of treating hepatitis C complications, such as liver transplantation and liver cancer, was spread over many years. Then along came a disruptive medical innovation in 2014 that quickly cured this serious liver disease. That sea change has both immediate and long-term effects on health care costs. The immediate effect is the need to treat a large number of patients, while over time an increasingly smaller number of patients need treatment as the disease becomes rarer. In the United States alone, the long-term effect is that the use of these new medicines is predicted to prevent by 2050 more than 126,000 liver-related deaths, 78,800 cases of liver cancer, and nearly 10,000 liver transplants.The FDA’s recent approval of glecaprevir and pibrentasvir (Mavyret) with a wholesale acquisition cost of $26,400, compared with $74,760 for the first similar curative treatment regimen for all forms of hepatitis C, launched in 2016, shows how quickly the situation can change.Similar to the extrapolation of the drying up of oil reserves or the “budget-busting” migraine treatment, making projections based only on the current price and sales underestimates the dynamics of the pharmaceuticals market. Yes, the immediate budget impact in most countries is a matter for concern, in particular as budgeting generally looks at drug expenditures in silos and does not take into account the savings in hospital costs or increased productivity.But what such extrapolations fail to take into account is that market dynamics can work quickly and effectively. As new competitors enter the market with other cures, prices come down. Regardless of administered pricing and tough negotiations in many countries, new competitors nowadays often enter the market within a few months of a first-in-class innovative medicine, leading to healthy price competition. The result: Doomsday scenarios of drug spending out of control prove to be exaggerated. Thomas B. Cueni @ThomasCueni Tags drug developmentdrug pricingpharmaceuticalslast_img read more

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6 things that happen at TV hospitals that don’t happen in real life

first_img Related: 5. Instant outOn “The Night Shift,” a large, angry prison inmate is wheeled in under armed guard. He yells insults and breaks his restraint before being instantly knocked out with an injection.“I wish we had a drug that could work that fast,” said Chai. “When they come in high or psychotic, those people are agitated, and it might take several people to hold them. That part’s true. But after the shot it takes about five to 10 minutes for them to calm down.”Wide-awake patients don’t just instantly fall unconscious either, no matter what they’re injected with. Whether a patient has missed doses of antipsychotic medication or is just high on street drugs, no injection can simply put them out in seconds.6. ‘Stat!’It’s still the official term of urgency and speed, but the word is uttered more often on television (and in our office) than in real life. On “ER,” “Grey’s Anatomy,” and “Chicago Hope,” among others, medical personnel jog alongside gurneys or run around patients’ rooms asking for a procedure or medicine, “Stat!”But in a real hospital, the word is usually written rather than “shouted out like it is on TV,” said Dr. Helen Farrell, a professor of psychiatry who’s had her share of emergency-room rotations.“You’ll see it usually on a written or electronic order, like for a drug, so that the pharmacy knows to get it up right away,” she added. “But you don’t usually hear people saying it.” Health6 things that happen at TV hospitals that don’t happen in real life By Leah Samuel Sept. 15, 2017 Reprints Related: “It’s not unheard of, I guess,” said Dr. Peter Chai, who teaches emergency medicine and medical toxicology at the University of Massachusetts. “Maybe in a pediatric situation, if it’s a kid, we may work on them for 45 minutes or so. But most times, you’re doing things in increments of three minutes,” he added. “So you’re shocking them after three minutes of CPR, or after EMS has been doing it on the way there. And by then, you either get them back or you don’t.”2. Gory scenesRobert Mills, media and editorial director at the American Medical Association, said that the PAC used to let TV directors know how to make scenes realistic. “They would tell the TV writers, ‘OK. If you do this procedure, this is how much blood you should see.’” It may be only a coincidence, but since the committee disbanded in the 1980s, medical shows have been awash in sticky red liquid.And TV blood is used to highly dramatic effect. It spatters across surgical masks and gowns and spurts dramatically from incisions. On “Grey’s Anatomy,” a wound over a patient’s carotid artery throbs menacingly and then pops open, throwing a wide, red streak across a doctor’s lab coat and blouse.“It doesn’t really happen that way,” explained Chai. “Even when you hit an artery [during surgery], its coming out a little faster than when you hit a vein, sure, but you’re not getting blood on the wall on the other side of the room.” Television shows like “ER” have had a number of fantastical storylines over the years. NBC/Newsmakers via Getty Imagescenter_img Medical storylines have riveted television viewers since the earliest days of the medium — and for just as long, TV writers and directors have had to navigate the age-old tension between truth and storytelling.One early solution, beginning in the 1950s, was a group of doctors who advised television producers directly. The group, known as the Physician’s Advisory Committee (PAC) on Television, Radio, and Motion Pictures, reviewed scripts, helped find props, and showed actors how to properly hold a scalpel.Both medicine and television have changed a lot since then. Production companies now hire their own medical consultants. And the widespread availability of medical information means that TV shows must work harder to get viewers to suspend their disbelief.advertisement 3. Surgery on the flyTV surgeons seem to be constantly called into action in every place except the hospital. In an episode of “The Night Shift,” Dr. Alister performed a C-section on a plane mid-flight (with, among other things, a pair of spoons). He was at it again in another episode when he drilled into a patient’s skull while awaiting help in a stalled elevator. “I’ve never seen any of that,” said Chai. “After all, we have these things called operating rooms.”And then there’s the similar scene where doctors are in or near a bank heist, war, or other gun-involved situation outside the hospital, and find themselves urgently needing to remove a bullet from the victim’s body. “MASH” and “ER” featured this one; “Chicago Med” almost did, when an overcrowded hospital forced Dr. Rhodes and Dr. Choi to consider a hallway bullet removal.“Nope,” Chai said. “If the bullet is in, it stays in until they’re in an operating room,” he said emphatically.4. Makeshift medicineTo save fictional lives, actors on hospital shows have used myriad non-medical implements — from garden hoses to tree limbs — in cases of emergency. The most common of the DIY procedures is a tracheotomy, in which a doctor makes a hole at the base of the throat to insert a tube when a patient has no other way to breathe due to injury or illness. “ER” offered a particularly memorable instance when Nurse Hathaway, held hostage by a pair of robbers in a convenience store, attempts a tracheotomy on a gunshot victim using a penknife, a juice straw, and duct tape.“We’re taught to do emergency tracheotomies, and you can even buy a kit to take with you,” Chai said, adding that he couldn’t understand why a lot of TV doctors seem to keep forgetting their kits.In most cases, Chai added, it isn’t even necessary to improvise. “Maybe if you’re in the middle of a hurricane or the wilderness, or in a rural area, then you can MacGyver something together to save a patient, but in ordinary cases, EMS has time to get there before you have to do that.” A cure for the common cold and 4 other medical predictions that haven’t (yet) come true 5 ‘health care’ jobs that are thankfully obsolete That desire for drama can create some unforgettable television moments — as well as some unlikely bits of fiction. Here, some of the most unrealistic parts of TV medical dramas.1. Shocking patients for an hourLast season’s “The Night Shift” featured this familiar scene: Dr. Clemmens leans over an unresponsive patient with a tube in her open mouth. His arms are straight and his hands are crossed on the young woman’s chest. He is desperately and rhythmically pushing into the patient’s chest, stopping every five pushes to allow another doctor, who has been holding the defibrillator pads aloft and ready, to shock the patient one more time.advertisementlast_img read more

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Just months after expanding, biotech incubator LabCentral growing again

first_imgBiotech About the Author Reprints What is it? GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What’s included? Log In | Learn More Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED How hot is the world of biotech startups in Cambridge, Mass.?LabCentral, a four-year-old nonprofit that leases shared laboratory space to fledgling companies, plans to announce Thursday that it is expanding yet again. “It’s outgrowing our wildest expectations,” LabCentral’s cofounder, Johannes Fruehauf, said of the incubator’s success. Jim Davis/The Boston Globe 2013 Tags biotechnologySTAT+ 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. Jonathan Saltzman — Boston Globe Just months after expanding, biotech incubator LabCentral growing again By Jonathan Saltzman — Boston Globe Sept. 22, 2017 Reprintslast_img read more

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