To keep science honest, study data must be shared

first_img King’s College London is refusing a professor’s request to release data from a controversial study about chronic fatigue syndrome, calling his request “vexatious” and an attempt to embarrass its faculty. Ian Lee/Creative Commons Related: Related: Last week, King’s added another rationale for its refusal: patient confidentiality. In a Dec. 18 press release, noting that it had released data to some independent scientists, it wrote: “The scientists who have already received data have all signed a formal confidentiality agreement, approved by the independent PACE Trial Steering Committee, which required that they respect the confidential nature of the data, and keep them secure, as agreed with trial participants when they consented to take part.”Now, patient confidentiality is critical, and must be upheld. PLOS ONE’s notice on the paper mentioned its importance, too. But if that’s really the crux of the matter, why not just ask Coyne to sign whatever agreement others have signed? (It hasn’t.) As others have pointed out, patients in the trial are among those asking King’s to release the data to Coyne, so it’s a bit puzzling why this is now a concern.Unless, of course, Uncle Scrooge has some skeletons hiding in the closet. By Ivan Oransky and Adam Marcus Dec. 23, 2015 Reprints Governments routinely cover up scientific misdeeds. Let’s end that Fraudsters discover an unlikely new set of victims: academics center_img The article, part of what’s known as the PACE trial, was written by King’s researchers along with colleagues from the University of Oxford and Queen Mary University of London. It reported that two particular treatments — known as cognitive behavioral therapy and graded exercise therapy — were effective. But many researchers question those conclusions, as David Tuller of the University of California, Berkeley, has reported.Coyne petitioned King’s, which with Queen Mary co-owns rights to the data, for access to the material. After what it calls “careful consideration,” the college decided his request fell under the UK’s Freedom of Information Act (FOIA), and turned him down. “The university considers that there is a lack of value or serious purpose to your request,” Ben Daley, the institution’s information compliance manager, wrote in a Dec. 11 letter to Coyne. “The university also considers that there is improper motive behind the request. The university considers that this request has caused and could further cause harassment and distress to staff.”advertisement Santa, if you’re reading this: James Coyne has a simple request for Christmas.Coyne, professor of health psychology at University Medical Center Groningen, in the Netherlands, would like to see the data from a controversial study about chronic fatigue syndrome that appeared in a 2012 issue of the journal PLOS ONE. King’s College London is refusing, calling his request “vexatious” and an attempt to embarrass its faculty.To be clear, Coyne’s not asking for sex tapes or pictures of lab workers taking bong hits. He’s asking for raw data so that he can evaluate whether what a group of scientists reported in print is in fact what those data show. It’s called replication, and as Richard Smith, former editor of The BMJ (and a member of our board of directors), put it last week, the refusal goes “against basic scientific principles.” But, unfortunately, stubborn researchers and institutions have used legal roadblocks before to prevent scrutiny of science.advertisement The seemingly bureaucratic decision to classify this as a FOIA request was a key move, because the UK’s act has what’s known as a “vexatious” provision that allows institutions to exempt materials when they determine that requests are, well, vexatious.The university attempts a reasonable tone here — but it’s dead wrong. If the information Coyne is seeking is harmful and distressing to the staff of the university — and that’s the university’s claim, not ours — that’s only because the information is in fact harmful and distressing. In other words, revealing that you have nothing to hide is much less embarrassing than revealing that you’re hiding something.Read more: A lot of science isn’t groundbreaking, and that’s a good thingAnd as PLOS ONE noted, its data policy requires that authors “make freely available any materials and information described in their publication that may be reasonably requested by others for the purpose of academic, non-commercial research.” Other than that last commercial exception, institutional imperatives and motivations here are, frankly, irrelevant.We’ve seen FOIA requests decried as vexatious on this side of the pond, too. In February, the Union of Concerned Scientists issued a report in which it said some such requests could be “bullying” and “harassment.” The UCS position — which became a flashpoint in the messy retraction of a blog post — attempts to draw the harassment/justifiable line where requests interfere with researchers’ ability to perform their jobs and freely pursue whatever inquiry they choose. But it’s never really been very clear to us where that line lies. Instead, the now-retracted blog post said it seems like a “campaign to blunt the tools with which the public can investigate claims of scientific malfeasance.”All of this is a troubling development for science, a field that wants the public to believe that transparency is one of its guiding principles. We’d like to believe that, too, but when researchers refuse to share data, and how they came up with it, they lose the right to call what they do science. The ability of other researchers — including competitors — to try to poke holes in an analysis is a bedrock of the scientific method. Tags datareplicationresearch The WatchdogsTo keep science honest, study data must be shared last_img read more

How many calories does Trump’s hand-waving actually burn?

first_img Donald Trump says he gets most of his exercise from campaigning. How many calories does his hand-waving actually burn? Matthew Orr/STAT So, if Trump gesticulated for the duration of a 45-minute stump speech, he’d burn between 120 and 160 calories.That would seem to fall short of the exercise habits of sitting world leaders. In a 2008 letter, then-Senator Obama’s doctor wrote that he exercises regularly, “often jogging three miles.” Hillary Clinton “exercises regularly, including yoga, swimming, walking and weight training.” Canada’s prime minister and Mexico’s president were recently spotted running together.advertisement The Trump workout planVolume 0%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/09/15/donald-trump-hand-gestures-exercise/?jwsource=clCopied EmbedCopiedLive00:0000:4000:40  Tags Donald TrumpPresidential campaign By Ike Swetlitz Sept. 15, 2016 Reprints Related:center_img In his appearance Thursday on “The Dr. Oz Show,” Donald Trump touched on various aspects of his health, including physical activity — saying that the “motion” he uses during speeches is a “pretty healthy act.” He’s previously made similar claims, telling People last year that “speaking is almost a form of exercise” for him.Trump sure does gesticulate generously. But how does that translate into calories burned? Luckily scientists have come up with a standardized way to compare different forms of physical activity. The exertion is measured in units of METs, short for “metabolic equivalent of task.” This is a way of comparing how strenuous different activities are: watching television sitting down has a value of 1, tap dancing measures 4.8, and vigorously chopping down trees racks up 17.5 points. The values are collected in the “Compendium of Physical Activities.”The compendium even has entries that could describe Trump’s behavior: “sitting, fidget hands” and “standing (fidgeting).” They fall between 1.5 and 2 on the physical activity scale.advertisement 5 takeaways from this week’s Clinton-Trump medical circus If Trump was looking to do the equivalent of a 30-minute, 3-mile run completely with his hands, he’d have to gesticulate for between two and a half and three and a half hours. HealthHow many calories does Trump’s hand-waving actually burn? last_img read more

The real plague affecting science? It isn’t fraud

first_imgBut first the findings. Researchers in the Netherlands asked working scientists around the world to rank a list of 60 misbehaviors by their impact on truth, trust in science, how often they occur, and how preventable those actions might be. They then devised a ranking for these behaviors that combined how often they occur and their impact — a sort of on-base plus slugging average that measures their overall effect on the field. By Ivan Oransky and Adam Marcus Dec. 1, 2016 Reprints Victor R. Caivano/AP The WatchdogsThe real plague affecting science? It isn’t fraud Related: Not surprisingly, fabrication of data scored the highest for its effect on truth and public trust in science. But those cases are quite rare — and detected cases are, by definition, even rarer. As a result, it didn’t even make the top five.advertisement But some approaches that have already been evaluated don’t appear to work so well. For instance, efforts to reduce plagiarism may help, but those to reduce the incidence of fraud, not so much.More study of interventions is definitely needed. And while universities continue to sponsor such initiatives, they should also take a hard look at their own roles in promoting “publish or perish.” After all, their tenure and promotion committees often take the easy route of counting papers to judge a body of work, instead of doing the hard work of plowing through the papers themselves. Until they do, we’re not likely to make much headway on the small but insidious problems plaguing science. Rather, “our ranking results seem to suggest that selective reporting, selective citing, and flaws in quality assurance and mentoring are the major evils of modern research,” the authors wrote in Research Integrity and Peer Review. “A picture emerges not of concern about wholesale fraud but of profound concerns that many scientists may be cutting corners and engage in sloppy science, possibly with a view to get more positive and more spectacular results that will be easier to publish in high-impact journals and will attract many citations.”Sloppiness and fraud often share a mother: the imperative to publish, and ideally in high-profile journals. And it is shockingly common: While about 2 percent of researchers admit to committing fraud in their research, as many as 34 percent of scientists say they have cut corners or taken similarly questionable steps in their work.So what should we do?The authors suggest throwing some science at the problem. “All attempts to fight sloppy science and worse should ideally be accompanied by sound evaluation to assess their effects,” they wrote. For young scientists, a supervisor’s fraud can derail a career Related: Do scientific fraudsters deserve a second chance? If a burst pipe in your house is flooding your basement, you’re probably going to be more worried about that than the couple termites you previously spotted. But multiply those termites times a thousand and suddenly the bigger threat to your house might be, well, the little things.The same holds true for science. Science fraud draws urgent attention whenever it comes to light, the equivalent of a busted pipe emergency. But it turns out, most scientists think it’s a far lesser threat to their field than the small, but legion, instances of underreporting of negative findings and scientists’ use of shoddy methodology.And — although it may be surprising coming from two people who run a blog that often focuses on scientific misconduct — we agree.advertisement Tags researchlast_img read more

This year’s scientific discoveries that made us say ‘Huh?’

first_img Tags cardiologygeneticsneuroscienceresearch In the LabThis year’s scientific discoveries that made us say ‘Huh?’ Every school child learns (wrongly) that Archimedes yelled “Eureka” when he discovered the principle of buoyancy while taking a bath.The story is apocryphal, and in fact, such flashes of inspiration are rare in science. Discoveries most often arise from hours of painstaking and frustrating work in the lab. Far more common than these “Aha!” moments this year were head-scratching insights that we have dubbed “Huh?” moments.Here are our favorite “Huh?” moments of 2016. We’re eager to hear yours as well, in the comments section below.advertisement 3. Virginity genesGenetics may account for up to one-quarter of the difference in the ages when people start having sex, University of Cambridge geneticist John Perry reported. “Sure, choice has a massive role in this, but there are biological and genetic factors, too,” he said. While the study of more than 125,000 people in the UK, Iceland and the United States didn’t prove cause and effect, it found associations between the timing of first sexual experiences and gene variants corresponding with fertility, start of puberty, and propensity to take risks.4. The bigger the yawn, the bigger the brainYawning may be more than merely a sign of exhaustion. Scientists have theorized that stretching our jaws and sucking in air cools the brain and can increase blood flow, suggesting that yawn duration should correlate with brain size and complexity. Indeed, a psychologist at the State University of New York at Oneonta found that the average duration of yawns in 109 individuals from 19 species — including humans, African elephants, walruses and rabbits — predicted a species’ brain weight and its number of cortical neurons. The average dog yawn, by the way, was .43 seconds longer than the average for cats.5. Happy heart syndromeIt’s not just sadness that can break your heart. So can moments of extreme joy, such as your wedding or the Cubs finally winning the World Series. In a condition known as takotsubo cardiomyopathy, part of the heart freezes up temporarily, causing it to resemble a takotsubo, or Japanese octopus trap. The vast majority of these cases are triggered by intense negative emotions, but a University Hospital Zurich physician reported identifying 20 patients whose condition, which results in irregular blood flow, was sparked by elation.So, New Year’s Eve revelers, don’t go too crazy when the ball drops on 2016. facebook.com/gideon.gil.9 Sasha/Getty Images 1. Ticklish rodentsWe humans are not — as thinkers going back to Aristotle thought — uniquely ticklish: Rats are too. This discovery was called “innovative and groundbreaking,” but the best part was the realization that some scientists spend their days tickling rats. Shimpei Ishiyama, a post-doc at Humboldt University in Berlin, who introduces himself at parties and bars as the “rat tickler,” reported that the critters squeaked and jumped with pleasure when he tickled their backs and bellies. These signs of joy changed according to their mood. It remains a mystery, though, why tickling has been conserved by evolution and has such a powerful impact on us — and rats.2. Pain is contagiousRodents were the source of another strange finding this year: Sensitivity to pain can be spread by smell. Alcohol withdrawal makes mice and people feel pain more acutely, but researchers at Oregon Health and Sciences University found that mice living in the same room as animals going through withdrawal became similarly sensitized to pain. When bedding from the mice undergoing withdrawal was then put in the cages of mice in another room, they too became less pain-tolerant — suggesting scent was the culprit. If the finding is borne out, it could mean that mouse experiments on everything from drug withdrawal to painkillers could have been skewed, the researchers said.advertisement Gideon Gil Managing Editor About the Author Reprints By Gideon Gil Dec. 29, 2016 Reprints @gideongil [email protected] last_img read more

US health care relies heavily on foreign workers. Trump’s immigration ban is raising alarms

first_imgHospitalsUS health care relies heavily on foreign workers. Trump’s immigration ban is raising alarms Related: Even with the supply of foreign-born workers, providers are stretched thin by the demands of an aging population and the high percentage of Americans struggling with chronic diseases. Before Trump’s order, many industry leaders had been pushing to bring in more workers, arguing for the elimination of barriers such as complex accreditation requirements.Beyond the impact on hospitals, Nazem, the founder of Nomad Health, said the executive order stands to undercut the broader principle that America is a melting pot whose success is built on its willingness to welcome talented workers, regardless of their backgrounds.“I would hate to see us lose our position as a leader in the world of science and medicine because we are unwilling to accept the best and brightest due to an irrational fear,” he said. “I know a lot of the people affected by this ban, and I can tell you with absolute certainty that they are decent people who America would be proud to have.”  Kate Sheridan contributed reporting. CLEVELAND — President Trump’s temporary immigration ban could quickly undermine American health care, which relies heavily on foreign-born labor — including many workers from the Middle East — to fill critical gaps in care, industry specialists say.As many as 25 percent of physicians practicing in the US were born in another country. Rural clinics and public safety-net hospitals, in particular, rely on foreign medical school graduates to take care of isolated and vulnerable populations. They often serve as primary care doctors, filling a vital need as more American-born MDs gravitate toward high-paying specialties.And it’s not just foreign doctors who are needed: A STAT review of visa requests found that employers seek to bring in thousands of occupational and physical therapists, dentists, pharmacists, and other health professionals each year. In 2014, the last year for which data is available, more than 15,ooo foreign health care workers, nearly half of them physicians and surgeons, received H-1B visas, which are designed to bring skilled labor into the US.advertisement @caseymross “If you go to almost any hospital, a community hospital or a teaching hospital, you will find a very substantial number of people from the Middle East,” he said. “This is just mind-blowing.” About the Authors Reprints As Trump worked on his immigration ban, Hillary Clinton showed her support for immigrant cancer researchers Trump’s immigration order could stop medical careers before they begin By Casey Ross and Max Blau Jan. 30, 2017 Reprints The travel ban could also disrupt training programs at hospitals and medical schools and undermine patient care.“We have huge concerns about this,” said Dr. Bruce Siegel, chief executive of America’s Essential Hospitals, which represents safety-net providers across the US. “In many of our underserved communities, people from overseas are the backbone of the health care workforce.”Siegel said the percentage of foreign-trained doctors tops 25 percent in states such as New York and New Jersey.“It’s early to tell, but this could have implications for decades to come,” Siegel said. “We could be shutting down a big part of the physician pipeline. … We’re going to lose people in areas we need the most. Often, the American grads get into specialty residencies, while international residents meet the needs of primary care.” [email protected] Darren Hauck/Getty Images The data don’t indicate how many foreign health care professionals come from the seven predominantly Muslim nations targeted by Trump’s executive order, but health care executives say the Middle East is a crucial pipeline.“I had trouble sleeping last night, to tell you the truth,” said J.B. Silvers, a trustee of The MetroHealth System here in Cleveland and a professor of health care finance at Case Western Reserve University.advertisement Casey Ross Related: The travel ban is meant as a temporary measure, in place for 90 days. But Trump has pledged to institute “extreme vetting” to more tightly control immigration from those nations after the ban is lifted. He has also talked about making major changes to the H-1B visa program that lets hospitals bring in so many foreign workers.The uncertainty is creating a sense of crisis in some hospitals — especially those that have seen some of their workers ensnared by the order, held in airports or sent back overseas when trying to return to the US from trips abroad. Hospitals are also scrambling to figure out how to help foreign patients who had been scheduled to come to the US for surgery in the coming weeks.  “Everyone is sort of in a state of paralysis,” said Dr. Alexi Nazem, an internist at NewYork-Presbyterian and founder of Nomad Health, an online physician staffing firm. “We don’t know how to interpret the order that was issued on Friday or what the long-term version of it is going to be.”Nazem was born in the US, but some of his relatives are Iranian immigrants now working in health care in the United States. “These are hardworking doctors providing care to Americans,” he said. “They have done absolutely nothing wrong and love this country, and now they may be kicked out of it. That’s a travesty for them personally, but also for the people who depend on them.”A Cleveland Clinic doctor was prevented from reentering the US on Saturday because she was carrying a passport from Sudan, one of the seven nations affected by Trump’s order. She was flown to Saudi Arabia, and the clinic said it is trying to secure her safe return.Foreigners’ role in US health care has steadily grown. The foreign-born share of health care workers jumped as high as 30 percent in the 1990s, up from 5 percent in the 1960s, according to a 2014 study from Georgetown University’s Center on Education and the Workforce. Health care now has the largest percentage of foreign-born and foreign-trained workers of any industry in the country, the study found.The visa applications underscore that reality: The Cleveland Clinic last year certified applications to bring in just under 200 foreign workers, mostly doctors and clinical associates. Other major employers seeking to bring in health care workers include Emory University, the Mayo Clinic, and William Beaumont Hospital in Michigan.Federal legislation has encouraged the trend. For example, the Nursing Relief for Disadvantaged Areas Act of 1999 created a special visa classification to encourage more foreign-born nurses to come to the US to deliver care in rural communities.Trump’s order also stands to undermine hospital IT staffs that rely heavily on foreign talent to develop software and digital health products, and to manage reams of sensitive internal data. Many leaders in the health IT field criticized Trump’s order, including athenahealth chief executive Jonathan Bush, who posted several scathing tweets.  Feeling like man w/o country. Forget buffoon Trump. He was lost from hello. How can @PRyan support this? Wtf?? https://t.co/KzxXEUS3qG— Jonathan Bush (@Jonathan_Bush) January 28, 2017 National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. Tags hospitalsimmigrationphysiciansWhite Houselast_img read more

After 40-year odyssey, first drug for aggressive MS wins FDA approval

first_img Log In | Learn More By Ron Winslow March 28, 2017 Reprints Forty years ago, one of Dr. Stephen Hauser’s first patients was a young Harvard Law School graduate and White House aide with a case of multiple sclerosis that raced like a brush fire through her brain. She quickly lost her ability to speak, swallow, and breathe. She got married in a wheelchair in her hospital room, tethered to breathing and feeding tubes and dressed in her wedding gown.“We had nothing to treat her with,” recalled Hauser, now director of the Weill Institute for Neurosciences at the University of California, San Francisco. It was such a searing moment for the young doctor, then at the beginning of his neurology training, that he decided to dedicate his career to MS research. 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. [email protected] Dr. Stephen Hauser in his office at the University of California, San Francisco. Elizabeth D. Herman for STAT @ronwinslow GET STARTED About the Author Reprints What is it? Health After 40-year odyssey, first drug for aggressive MS wins FDA approval Ron Winslow What’s included? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags biotechnologydrug developmentneurologypharmaceuticalspolicylast_img read more

Drug makers loathe these patent challenges, and more are being filed than ever before

first_img Last fall, Allergan (AGN) transferred rights for six patents to a best-selling eye drug to a Native American tribe, focusing unprecedented attention on a type of patent challenge that vexes brand-name drug makers. Called inter partes reviews, these are heard before a U.S. Patent and Trademark Office appeals board, not a court, and are generally easier and faster to pursue than more conventional patent lawsuits.Not surprisingly, there are more of these challenges being filed than ever before. 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 Ed Silverman Feb. 13, 2018 Reprints The U.S. Supreme Court may rule in the spring on a type of patent challenge called inter partes review. Jon Elswick/AP 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. Log In | Learn More About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot center_img What is it? [email protected] @Pharmalot Drug makers loathe these patent challenges, and more are being filed than ever before Ed Silverman GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags financepatentspharmaceuticalsSTAT+last_img read more

People don’t go to doctors to be entertained. Why do they turn to celebrities for health advice?

first_img Christopher Polk/Getty Images Tags physiciansVaccines The vaccine article struck serious chords in the medical community, and doctors took some sharp jabs at the piece. Many physicians chimed in that the medical community couldn’t care less about a non-medical person’s views on one of the most remarkable worldwide public health successes in history. It’s enough of challenge for physicians to explain the safety and effectiveness of vaccines to patients and families, let alone having to answer the claims of movie stars. Others expressed dismay that a mainstream parenting magazine provided yet another stage to some of the most powerful anti-vaccination voices, one of whom has lately played a key role in the anti-vaccination movement.But the magazine ended up making some changes to the article, trimming two celebrities off the list, and adding an introduction about how the magazine supports vaccines and how they find it “irksome” that some celebrities feel otherwise. Included in that group was Jenny McCarthy, perhaps the loudest voice that helped the anti-vaccination movement get to where it is today. Irksome, indeed. Americans believe in experts. We look to CPAs to complete our tax returns, lawyers to handle our disputes, plumbers to fix our pipes. So it baffles me that an astounding number of us turn to movie stars and other celebrities for health advice.Take a recent article in Parents magazine: “Where 13 Celebrity Parents Stand on Vaccinating Their Kids.” In it, 13 successful actresses, including Alicia Silverstone, Julie Bowen, and Amanda Peet offered their opinions and advice on issues such as the safety, effectiveness, and timing of vaccines. They also shared their thoughts on vaccinating — or not vaccinating — their children.Why do their opinions matter? They are celebrity actresses, with their own incredible talents, smarts, and savvy. But they aren’t doctors, nurses, or scientists with expertise in immunology or public health.advertisement Leave this field empty if you’re human: It’s a shame that the noise reverberating from celebrity platforms often distorts or drowns out dry but solid data. Thankfully, those without IMDb pages are now spreading the gospel of data, with books, television, and popular live events. Bill Nye was a nerdy high school kid, cum nerdy children’s science show guy. Now look at him. Astrophysicist Neil deGrasse Tyson is a veritable rock star.Fortunately, the editors at Parents magazine listened and responded when called to task about touting the medical views of celebrities. I’d like to believe this signals that we are headed toward a time when scientists will again be the voice of science, and celebrities will again be the voice of celebrity, but I’m not holding my breath.Nina Shapiro, M.D., is the director of pediatric otolaryngology and professor of head and neck surgery at the David Geffen School of Medicine at UCLA, and author of “Hype: A Doctor’s Guide to Medical Myths, Exaggerated Claims and Bad Advice,” to be published by St. Martin’s Press (May 2018). Related: First OpinionPeople don’t go to doctors to be entertained. Why do they turn to celebrities for health advice? By Nina Shapiro March 15, 2018 Reprints Illnesses such as whooping cough, measles, and mumps — once common and potentially deadly — were made uncommon by vaccinations. Today, though, outbreaks continue to occur in pockets of the U.S., commonly in wealthy regions where the privileged set choose not to vaccinate their children or to delay their vaccinations. Such decisions can be deadly. During this flu season, one of the worst in decades, thousands of previously healthy children and adults have died of the flu, most of whom were not vaccinated against it. At its peak in early February, the flu was responsible for 1 of every 10 deaths and on a killing spree to the tune of 4,000 Americans a week.When celebrities give vaccines mediocre ratings, their voices are heard. That gives power to the growing number of skeptics on vaccine safety and efficacy — even against the flu shot.The celebrity effect isn’t limited to vaccines. Celebrities write books on health and wellness, childrearing, diet and nutrition, pregnancy, mental health, and more. They roll out health product lines, organize and run health conferences, and sell ideas that are such utter nonsense it should make any reasonable person’s head spin. Most of these ideas are backed by shoddy science, or no evidence at all. Gwyneth Paltrow touts coffee enemas to “detox” the body and jade eggs inserted into a woman’s nether regions to improve colonic and sexual health. Silverstone claimed that chewing and regurgitating food was the best way to feed one’s offspring. These absurdities are elevated by each star’s platform.True advancements such as the human genome project, precision imaging technology, targeted chemotherapy and radiation, and gene therapy are just a handful of the remarkable game changers in health care. Widespread immunization is another. Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. It’s enough of challenge for physicians to explain the safety and effectiveness of vaccines to patients and families, let alone having to answer the claims of movie stars. Nina Shapiro An ultrasound on Instagram suggested the baby could be in danger. Does a physician have a duty to warn? Please enter a valid email address. Privacy Policy What they do have is a platform, something most doctors and scientists don’t have and few will ever possess. People listen to performers with platforms.When people hear a famous person’s personal views on family health decisions, they fall prey to the illusion that they have set foot beyond the boundary of that star’s coveted personal space. Although we may not carry cameras, we non-celebrities are paparazzi with different lenses, peering with interest into the personal habits of the rich and famous.advertisement @drninashapiro [email protected] About the Author Reprintslast_img read more

Swiss prosecutor eyes Novartis deal with Cohen, but no criminal probe is underway — for now

first_img The Swiss attorney general is eyeing the $1.2 million deal that Novartis made with Michael Cohen, President Trump’s personal lawyer, but is not conducting any criminal probe at this time, according to a statement from the federal prosecutor.As reported last week, Cohen approached Novartis in early 2017 to offer access to the new Trump administration. And Joe Jimenez, who was chief executive officer at the drug maker at the time, agreed to a one-year, $1.2 million contract, even though Cohen is not a registered lobbyist or an expert in health care policy. Swiss prosecutor eyes Novartis deal with Cohen, but no criminal probe is underway — for now Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints Log In | Learn More By Ed Silverman May 14, 2018 Reprints [email protected] What’s included? Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.center_img 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. GET STARTED Ed Silverman What is it? Pharmalot Swiss Attorney General Michael Lauber KHALED DESOUKI/AFP/Getty Images @Pharmalot Tags pharmaceuticalsSTAT+Trumplast_img read more

GoFundMe should stop embracing and promoting unproven clinical research

first_img Tubes of homeopathic granules LOIC VENANCE/AFP/Getty Images Privacy Policy Please enter a valid email address. Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Even more disturbing, recent publications in Lancet Oncology and the BMJ show that many cancer patients are enthusiastic users of crowdfunding for quack treatments such as homeopathy and energy healing. This research shows that people seeking crowdfunding are not only often wasting their donors’ money on these treatments, but they are also spreading misinformation about their effectiveness and safety when appealing to donors to fund these treatments. Some people are also using crowdfunding to help them opt out of proven effective treatments and palliative care, leading to preventable deaths and suffering. Medical crowdfunding, a large and rapidly growing practice dominated by the website GoFundMe, can be a lifesaver for people who find themselves unable to access cancer treatments, surgery, or other essential medical services due to gaps in insurance coverage or the failure of public institutions to meet their needs. But it is also helping raise funds for scientifically unproven and potentially dangerous medical treatments that are often packaged as legitimate clinical research and trials. Instead of trying to put a stop to these shady practices, GoFundMe is actually promoting them.Although crowdfunding is a flawed solution to lack of access to health care, GoFundMe correctly sees the use of its services as a response to real and devastating health system failures, especially in the U.S. Some individuals use this platform to access legitimate medical services. But others use donations to pay for unproven and largely ineffective treatments such as homeopathy and stem cell injections.Last year, two colleagues and I reported in the Journal of the American Medical Association that we identified more than 400 crowdfunding campaigns (almost 90 percent of them on GoFundMe) seeking donations for stem cell interventions. A different trio of researchers identified more than 1,000 crowdfunding campaigns (98 percent of them on GoFundMe) for five poorly supported or potentially dangerous treatments: homeopathy or naturopathy for cancer, hyperbaric oxygen therapy for brain injury, stem cell therapy for brain or spinal cord injury, and long-term antibiotic therapy for so-called chronic Lyme disease.advertisement By Jeremy Snyder March 11, 2019 Reprints She said she had cancer, and neighbors opened their wallets. Then a stranger’s email raised questions But this isn’t happening. And we know it isn’t happening.GoFundMe recently sought to position itself not only as a solution to genuine health system failures, but also as a solution to those that don’t exist. In a recent interview with Kaiser Health News, GoFundMe CEO Rob Solomon said, “A lot of insurance doesn’t cover clinical trials and research and things like that, where people need access to leading-edge potential treatments. We strive to fill these gaps until the institutions that are supposed to handle this handle it properly.”Increasing funding for research and patient participation in clinical trials is a desirable enterprise, but using crowdfunding to do it is incredibly problematic. “Regular” crowdfunding widens inequities in access to care by giving the greatest benefits to those with strong social networks, media contacts, and tech savvy. Crowdfunding for experimental medicine will replicate these problems for those seeking access to clinical trials.And just as crowdfunding provides incentives for users to exaggerate the effectiveness and safety of unproven treatments via their campaigns and social media, there is every reason to think that this same problem will exist in crowdfunding for participation in clinical trials and access to experimental treatments.Moreover, research on crowdfunding for unproven medical treatments has shown that many businesses recognize crowdfunding for the massive revenue stream it is, directing their customers to crowdfund unproven treatments that health systems and insurers — rightly — will not pay for. This will likely happen in the realm of more legitimate experimental medicine and clinical trials as well, especially given the new Right to Try Act signed into law in the U.S. in 2018. [email protected] About the Author Reprints For example, BrainStorm Cell Therapeutics announced in the summer of 2018 that it would make access to its experimental stem cell treatment for ALS available through “right to try.” After public outcry that this company was considering charging customers $300,000 to exercise this right, BrainStorm’s CEO changed course, citing a failure to “identify a practical funding solution” for those unable to afford their product.It doesn’t take a great deal of imagination to see that companies will embrace Solomon’s vision and see crowdfunding as a “practical funding solution” to making their products available through right to try or by evoking such a right without actually using expanded access programs. While BrainStorm, to its credit, chose not to go down this path, crowdfunding campaigns are currently actively raising money to pay for participation in the company’s clinical trial. Thousands of other crowdfunding campaigns are actively seeking funds for desperately ill recipients to participate in clinical trials, exercise their rights to try, and purchase “experimental” treatments.I find Solomon’s approach of treating crowdfunding for unproven treatments as a feature of medical crowdfunding rather than a failure of it as deeply problematic. While there are undoubtedly legitimate clinical trials that would benefit from patients who responsibly use crowdfunding to raise money to participate, research I conducted with my colleague Leigh Turner shows that this is the exception rather than the rule.Crowdfunding creates an opportunity for unscrupulous businesses to sell their products to a wider audience under the guise of experimentation, research, and clinical trials. At the same time, the majority of crowdfunding campaigners misrepresent and exaggerate the effectiveness and safety of the treatments they hope to pursue, spurred on by the need to convince donors that their money will be effective in drastically improving the campaigner’s health. @jeremycsnyder Leave this field empty if you’re human: GoFundMe needs to do better to prevent its platform from being used to raise money for unproven and dangerous medical treatments, mislead donors and other members of the public, and steer people away from proven treatments. Without such campaigns, this money doesn’t get raised, this misinformation isn’t spread, and people aren’t steered away from effective treatments and palliative care. Simply put, these harms don’t happen. By enabling them, GoFundMe is complicit in these harms.If GoFundMe won’t address this problem on its own, the government should do it for the company. This could take the form of GoFundMe being held responsible for allowing and encouraging individuals to make false claims about medical products. Just as the Federal Trade Commission is increasingly warning stem cell clinics to stop deceptive advertising, and the FDA is warning clinics to stop marketing stem cell therapies without FDA approval, GoFundMe could be held responsible for knowingly allowing its platform to be used to parrot and exaggerate false claims for unproven therapies.Crowdfunding is undeniably being used to finance and promote businesses selling unproven medical treatments under the guise of experimental medicine and mislead the public about their safety and efficacy. This involves thousands of recipients, tens of thousands of donors, and hundreds of thousands of people on social media. GoFundMe needs to stop being complicit, and even glorying in this problem, and help solve it.Jeremy Snyder, Ph.D., is a professor in the Faculty of Health Sciences at Simon Fraser University in British Columbia, Canada. Jeremy Snyder Tags ethicsresearchstem cells Related: GoFundMe is aware of this problem and could take actions to better educate its users about unproven treatments and prohibit the most dangerous and misleading campaigns. Instead it is taking a “buyer beware” position. In a statement, the company suggested that it is “not our place to tell [donors] what decision to make” and that campaigners need to “fully research whatever it is they are raising money for and to be absolutely transparent on their GoFundMe page, so donors can make an informed decision on what they’re donating to.”advertisement Related: Crowdfunding raises millions for unproven — and potentially harmful — treatments First OpinionGoFundMe should stop embracing and promoting unproven clinical research last_img read more