Why isn’t Harvard getting rich off its scientific research?

first_img How an obscure law brought us nasal flu spray — and new conflicts of interest Harvard ranks 25th among universities and university systems in terms of the number of faculty inventions it licensed or optioned out to industry in the 2012-14 fiscal years, according to data from the Association of University Technology Managers.Read more: Inside the quest to turn a Harvard discovery into a blockbuster cough medicineThe STAT analysis ranked Harvard 20th in efficiency, a measure that takes into account the amount of research spending and how many faculty discoveries have been commercialized at the top business-generating schools. The University of Georgia got five times more bang for its research buck by this measure.advertisement Aspiring biotech entrepreneurs ‘would be crazy’ not to take this Harvard class BusinessWhy isn’t Harvard getting rich off its scientific research? The Harvard name is among the most prestigious in the world. Thousands of the best scientific researchers work at its top-ranked medical school. And it sits within a few miles of one of the world’s foremost engines of medical innovation, the biotech hub of Kendall Square.Yet when it comes to converting the scientific discoveries of its faculty members into blockbuster drugs and devices, Harvard falls short.A STAT analysis of data updated in September finds that Harvard — used to being at the top of most rankings that count — isn’t even in the same league as many US universities by several measures of success in commercializing faculty research.advertisement And when it came to earning royalties and other income on the fruits of its faculty’s inventions, Harvard was just 27th. To put that into perspective: Over the course of those three years, Northwestern and NYU each brought in over half a billion dollars more in royalties than mighty Harvard.So what’s going on here?You might guess that Harvard isn’t investing in commercializing its research. But Harvard is a decade into a push to do exactly that.In 2005, the university brought in Isaac Kohlberg, a whiz kid from Israel, to jumpstart its tech transfer office, which works on commercializing faculty members’ eureka moments in the lab by creating startups or launching partnerships and licensing deals with existing businesses.And industry insiders think he’s doing a good job. “Isaac Kohlberg is a really hard charger. He’s got some very sophisticated ways of doing this, and they’re really very proactive,” said AUTM president Fred Reinhart. (The AUTM’s data, which STAT used for the analysis, is fairly complete, but a small number of universities don’t report their data, and there is some variation in the way each institution counts licensing deals.) Related: For the University of Florida, which ranks 16th in the STAT revenue analysis, the silver bullet is Gatorade, developed by scientists at its medical school to help the football team — the Gators — withstand the withering heat and humidity.And the University of Illinois, at No. 19, is on the rankings map thanks to the HIV drug Prezista.Harvard, which has brought in less than $13 million annually from licensing income in recent years, hasn’t gotten that one big break.Payoff can be long in the makingEven when a university tech transfer office strikes gold with a faculty member’s discovery, it can take years or even decades to get from an academic lab to a revenue stream.Northwestern is profiting off a 1989 discovery. For the University of Illinois, it was the 1990s. And the University of Florida has to look all the way back to the 1960s for the invention of Gatorade, the source of much of its current revenue stream.Harvard is still waiting to see if a discovery made long ago will pay off in the near-term — or if a gem lurking in a Boston laboratory right now might pay dividends in the future. Michal Preminger, a director of business development for Harvard’s tech transfer office, said she and her team don’t dwell too much on how to bring in revenue for the university. They focus instead on how to help faculty and bring useful products to market to help patients, she said — knowing that success in those realms “will translate into financial return.”But the question remains: Why isn’t Harvard leading the pack when it has so many advantages? STAT spoke to experts around the country for some answers.Harvard’s not interested in peanutsThe University of Georgia, which the STAT analysis ranked as the most efficient in the nation at capitalizing on faculty research, has a recipe for success: peanuts.The university’s agriculture inventions are relatively low-cost and low-risk, including 19 varieties of peanut plants that resist disease, tolerate drought, and produce more nutritious nuts. Peanut products make up a significant plurality of the discoveries the school moves to the marketplace.By contrast, the cutting-edge biomedical research that Harvard and other elite universities prioritize is often costlier. Nine out of 10 experimental drugs fail in clinical trials, and many projects that tech transfer offices try to commercialize don’t even make it that far.For Harvard and other universities focused on drug development, that can mean a lot of spending with little payoff.Harvard has to share scientists with its hospitalsAt Harvard, many faculty hold joint appointments at nearby research hospitals — and some of their research is licensed by those hospitals, many of which have their own tech transfer offices.center_img Harvard has been falling short in converting the scientific discoveries of its faculty members into blockbuster drugs and devices. Lisa Poole/AP Related: By Rebecca Robbins Dec. 21, 2015 Reprints Harvard Medical School eases up on contentious ethics rule For instance, if a Harvard scientist with a primary appointment at Massachusetts General Hospital makes a discovery that leads to a blockbuster drug, the hospital — not Harvard — will likely reap the financial rewards.So for Harvard, an unusually vibrant neighborhood doesn’t always translate into more licenses or greater profits.Tech transfer can be a game of luckDirectors and staffers at a handful of top revenue-earning tech transfer schools all said they hit the jackpot on just one breakthrough.No. 1-ranked Northwestern has taken in hundreds of millions of dollars annually in recent years — the vast majority of its royalties income — from a discovery that led to the blockbuster anti-seizure drug Lyrica. Related: Tags drug developmentHarvardmedical researchlast_img read more

Architect with ALS designs a residence he can control with just blinks

first_img 5 makeshift — and ingenious — ways to improve medical devices But the most unusual difference is the way this place works. And Saling is partly responsible for that.advertisement CHELSEA, Mass. — Steve Saling is sitting in his bedroom at the Leonard Florence Center for Living just north of Boston. He aims his gaze at the tablet mounted to his wheelchair and, with a small movement of his facial muscles, raises the window shade to sunlit afternoon clouds.Now, behind thin, oval eyeglasses, Saling again blinks purposefully, like a telekinetic superhero. The door opens, and he steers his well-equipped wheelchair through smoothly.A landscape architect by trade, Saling was diagnosed 10 years ago with amyotrophic lateral sclerosis, or ALS, commonly called Lou Gehrig’s disease. It’s a neurological condition that affects nerve cells in the brain and spinal cord. Over time, people with ALS lose the ability to walk, speak, and move without assistance.advertisement Saling moves on and points toward the central, open kitchen. There’s a fire safety feature built in — important in an apartment with 10 severely disabled people. In case of fire, the kitchen is automatically walled off from the rest of the suite. This contains the smoke or fumes, and gives residents time to evacuate if necessary.Saling passes the kitchen and heads into the living room and dining area, decorated with framed abstract prints and a babbling television. Another man in a wheelchair chats with the staffer feeding him at the dining table.“We create our own menus and eat whenever we please, just like people in a real household,” Saling said, using one of the ready-made statements he cues up with his computer. Once it affects the vocal cords and other speech-related muscles, ALS leaves little room for spontaneous banter, especially for a tour Saling has given several times. The male voice from his speech unit, less like a robot than a newscaster, makes even the most mundane statements sound like narration in a documentary.Soon after his diagnosis, Saling had a chance meeting with Barry Berman, CEO of the Chelsea Jewish Foundation, which operates the Florence Center. He told Berman about his interest in creating a place where people with ALS could receive care, but remain as independent as possible even as they became more disabled.It wasn’t a tough sell, said Berman, but he had some catching up to do.“We had to call the ALS Association because we had no knowledge of the disease,” he said. Once he understood, he was on board.Saling with the monitor he uses to operate his automated home. Josh Reynolds for STATWorking against timeWhen architects from the Boston-based firm DiMella Shaffer began designing the apartments, Saling worked closely with them. He brought with him years of experience as a landscape architect.“I would attend weekly meetings consulting with the architects,” he said. “Especially on accessibility issues because, ironically, I was an accessibility expert when I worked professionally.”Berman recalled that Saling was working against time.“Steve was still driving and walking,” said Berman. “But he was walking with a cane and his voice was getting weak. He was already living in our assisted living facility.”But Saling used his disability to his advantage.“The notable impact that ALS had on my ability to design is speed,” he said. “I am a lot slower. But I have the time to really think about what I am doing, so there is an upside. Because much of my profession had been computerized and I excelled in computer-assisted drafting, I was still able to convey my ideas with a lot of precision.” As they become more disabled, people with ALS often move into long-term care facilities. The one Saling lives in, however, is not a typical nursing home. Big windows replace harsh artificial lights. Defiant reds, warm golds, and cheery greens replace the typical institutional palette of antiseptic blandness. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. ALS patient takes on one final fight: jump-starting research Privacy Policy By Leah Samuel July 6, 2016 Reprints HealthArchitect with ALS designs a residence he can control with just blinks Related: Leave this field empty if you’re human: The automation reduces some costs for the Florence Center, because fewer staff are needed. The residents still need help eating, bathing, and taking care of other day-to-day needs. “But having this technology means that during the day, you don’t have to call a nursing assistant when you want the window open,” said Mike Ferrick, the executive director of Florence Center.Even so, an automated home for people with ALS is expensive. “We lose money on these units every month,” said Ferrick. He said the ALS residences cost the Florence Center nearly $500,000 a year to run.Some of the cost is covered by the residents’ insurance, typically Medicaid, Medicare, or MassHealth, the state’s insurance program. The rest comes from donations, Ferrick said, or from the center’s overall budget. Profitable programs such as physical therapy bring in funds that the Florence Center uses to subsidize the assisted living residences.Despite the cost, Berman believes the ALS residences are worthwhile.“It’s a struggle,” he said. “But we knew we wanted to open a residence for people with ALS. Steve has dedicated his life to this, and I’m happy to be a part of it.”Correction: An earlier version of this story misstated the number of rooms equipped with the technology Saling designed and misstated the accessibility of the kitchen.  Unwilling to accept a life utterly dependent on caretakers, Saling designed a series of systems that let patients with ALS control their environment in the assisted living center with the barest of movements: blinks and facial twitches. They can open and close doors, turn on and off lights, change TV channels, and control heat and air-conditioning, among other things.The first cluster of accessible rooms, named for Saling, opened in 2010. Last month, the Florence Center opened a second set of rooms, called the Dapper McDonald ALS Residence. All told, there are now 30 bedrooms here equipped with systems that give patients with ALS, multiple sclerosis, or other disabling diseases some measure of independence.Saling also established the ALS Residence Initiative, a fundraising and advocacy group that aims to build more such homes to serve the estimated 12,000 ALS patients across the country. The group’s motto: “Until medicine proves otherwise, technology IS the cure.”The advocacy group is working with local ALS patients and caregivers to build automated assisted living homes in New Orleans (where the residence features a garden designed by Saling) and in Dahlonega, Ga. Fundraising and planning are underway as well in Dallas, Baltimore, and Windham, Maine.Patients with ALS “want to live in residences like this,” said Barbara Newhouse, president and CEO of the ALS Association in Washington. “We steer people toward resources that would benefit them, and this is one model of residential care that we look to.”Steve Saling, a retired landscape architect, sits in his room. Here, he can control the window shade, television, and door with subtle movements of his face. Josh Reynolds for STATCalling the elevator with a blinkSaling, 47, rolls past the art decorating his room — original works by his 9-year-old son, Finn, set against a deep-red wall — and out to a hallway, pulling up toward the elevator. He’d summoned the elevator before he left his room, and indicated where he wanted to go. The secret is a small, white box on the wall above the elevator call buttons. After Saling’s computer converts his blinks into radio frequency signals, the little box conveys them to a receiver in the basement. The signals are then sent as commands to the elevator’s computerized operating system.Saling recalled that there was skepticism about the elevator during the design process.“The biggest challenge was convincing the elevator sub-consultant that we could automate his elevator,” he says. “A few of the subs were reluctant to embrace change, but they all came around. It all came out beautifully.” Steve Saling helped design features of the Leonard Florence Center’s Dapper McDonald ALS Residence, intended to preserve the independence of those with ALS, where he is a resident. Josh Reynolds for STAT Please enter a valid email address. Related: Tags ALSdisabilitymultiple sclerosislast_img read more

MIT challenges New York Times over book on famous brain patient

first_imgLeave this field empty if you’re human: An equally incendiary claim in the book excerpt is that Corkin tried to suppress the discovery, by a scientist who studied H.M.’s brain after death, of a previously unknown lesion. Virtually all of the science built from H.M.’s memory loss held that it was the result of the surgery that removed his hippocampus. But neuroanatomist Jacopo Annese, then at the University of California, San Diego, acquired H.M.’s brain from Corkin soon after his death. He cut it into thousands of wafer-thin slices and studied it in 3-D detail, discovering the lesion in the frontal cortex.According to “Patient H.M.,” Corkin tried to downplay the significance of the discovery and stop publication of the paper reporting it, for fear that the abnormality in a region of the brain far from the destroyed hippocampus —supposedly the source of H.M.’s amnesia — would muddy the orthodoxy on how human memory worked. In the end, Annese listed her as the paper’s senior author, and the frontal lesion was reported prominently.“It’s there,” said Gabrieli. “And in an interview after [the paper’s] publication, she highlights it.” In a 2014 interview, Corkin said that the cause and the timing of the frontal lesion was unknown, and that it was “unclear whether this lesion had any consequence for H.M.’s behavior.” “Patient H.M.” recounts Corkin’s trying, in notes to Annese, to delete all references to the frontal lesion, saying it did not appear on MRIs when H.M. was alive, and “any consideration of it would be highly misleading.”A second letter to the Times, from just over 200 brain scientists, is less detailed. It is signed by some of the leading lights of neuroscience, from as far away as New Zealand, including Randy Buckner of Harvard; Adele Diamond of the University of British Columbia; Adam Gazzaley of the University of California, San Francisco; Eleanor Maguire of University College London; Henry Roediger of Washington University; Daniel Schacter of Harvard; and Scott Small of Columbia University.The signers say they are “disturbed” by a book excerpt, saying it describes Corkin’s research “in what we believe are biased and misleading ways.” Any hint that she did not behave with scientific integrity, they write, is “contrary to everything we have known about her as a scientist, colleague, and friend.”This story was updated on Wednesday with responses from the New York Times and Dittrich. Controversial CRISPR history sets off an online firestorm By Sharon Begley Aug. 9, 2016 Reprints Tags brainmemoryMIT Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. @sxbegle [email protected] The book, “Patient H.M.: A Story of Memory, Madness, and Family Secrets,” whose official publication date was also Tuesday, is notable for Dittrich’s connection to the most famous brain patient ever studied: H.M., as he is known in scientific publications (his full name, Henry Molaison, was revealed after his death in 2008).Experimental surgery in 1953 to treat Molaison’s epilepsy had removed or destroyed his right and left hippocampus, his right and left amygdala, and other structures. That left him with no ability to form memories, allowing scientists to make groundbreaking discoveries about how human memory works. The surgeon was Dittrich’s grandfather, and much of the book is an impassioned discussion of the moral complexities of the surgery.The Times excerpt focused on Corkin. Although much of the groundbreaking work on H.M. was done by Brenda Milner at McGill University in Montreal, Corkin (Milner’s graduate student) eventually took over as the lead scientist studying H.M., which involved giving him memory and other tests.Dittrich (who published a point-by-point rebuttal to the MIT criticisms on Medium on Wednesday) quoted a lengthy exchange with Corkin in which she seems almost smug about destroying key data sheets and other records of her work on H.M. The new Medium post includes the audio file of that exchange. MIT’s DiCarlo said he and two MIT colleagues who investigated the supposed destruction “cannot explain why professor Corkin made the comments reported in the article.” But they hypothesize that there were “tensions” between her and Dittrich “because she had turned down his request to examine Mr. Molaison’s confidential medical and research records.”In fact, said MIT neuroscientist John Gabrieli, “nothing was shredded or destroyed.” Corkin’s assistant, he said, “was strictly instructed to preserve everything.” Although there is no way to say definitively that every single document was preserved, said Gabrieli, “there is a whole room here filled with those files.”Dittrich said that if the supposedly shredded data still exist, “I would like to know whether MIT intends to index it and make it available to the public or other researchers.” Privacy Policy Sharon Begleycenter_img The Massachusetts Institute of Technology brain sciences department and, separately, a group of some 200 neuroscientists from around the world have written letters to The New York Times claiming that a book excerpt in the newspaper’s Sunday magazine this week contains important errors, misinterpretations of scientific disputes, and unfair characterizations of an MIT neuroscientist who did groundbreaking research on human memory.In particular, the excerpt contains a 36-volley verbatim exchange between author Luke Dittrich and MIT’s Suzanne Corkin in which she says that key documents from historic experiments were “shredded.” “Most of it has gone, is in the trash, was shredded,” Corkin is quoted as telling Dittrich before she died in May, explaining, “there’s no place to preserve it.”Destroying files related to historic scientific research would raise eyebrows, but Corkin’s colleagues say it never happened.advertisement “We believe that no records were destroyed and, to the contrary, that professor Corkin worked in her final days to organize and preserve all records,” said the letter that Dr. James DiCarlo, head of the MIT Department of Brain and Cognitive Sciences, sent to the Times late Tuesday. Even as Corkin fought advanced liver cancer, he wrote, “she instructed her assistant to continue to organize, label, and maintain all records” related to the research, and “the records currently remain within our department.”It is highly unusual for so many prominent scientists to take a newspaper to task over a book excerpt, especially when they do not also contact the publisher (Random House). One scientist criticizing the Times said they hadn’t thought of that. The scientists also complain that the newspaper did not fact-check the excerpt. In a statement, however, a spokesperson for the paper said the excerpt “was thoroughly vetted and fact-checked by the [Sunday] magazine’s staff.”advertisement In the LabMIT challenges New York Times over book on famous brain patient About the Author Reprints Related: Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. MIT neuroscientist Suzanne Corkin, who died in May 2016, shown with a rocking chair that “Patient H.M.” used as a child. Essdras M Suarez/Boston Globe Please enter a valid email address.last_img read more

The opioid epidemic is skyrocketing private insurance costs

first_imgFirst OpinionThe opioid epidemic is skyrocketing private insurance costs About the Author Reprints Related: The opioid epidemic has caused thousands of deaths, broken apart countless families, and endangered untold babies and children. It’s also taking a heavy economic toll.Private insurance is footing a large part of the bill for the opioid epidemic. But much of the existing information on private insurance costs has been limited, either because it didn’t include a large enough sample of private insurers or because it didn’t delve deeply enough into the specific services and price tags.My organization, FAIR Health, owns and continuously updates a database of more than 21 billion claims from privately insured individuals. In a recent white paper, we analyzed the rising ocean of privately billed claims associated with opioid abuse, dependence, and overdoses. Since then, we’ve launched a glass-bottom boat on that ocean to further explore key issues such as the costs of treating the rising population of patients receiving opioid-related diagnoses and the specific services that contribute most to those costs. Here are a few highlights from our latest report, titled “The Impact of the Opioid Crisis on the Healthcare System.”advertisement By Robin Gelburd Sept. 26, 2016 Reprints Robin Gelburd @FAIRHealth 26 overdoses in just hours: Inside a community on the front lines of the opioid epidemic Our analyses revealed some significant differences between charges for individuals with opioid abuse and those for individuals with opioid dependence. Opioid abuse, generally considered to be a less-severe problem than opioid dependence, requires only one symptom in a year for a diagnosis (such as continued opioid use despite recurrent social problems caused or worsened by opioids), while opioid dependence requires three or more symptoms in a year. Between 2011 and 2014, emergency room visits were the costliest charges for patients with opioid abuse. Among patients with opioid dependence, who are more likely to be treated in substance abuse programs than in emergency departments, drug screening tests (which are common in substance abuse treatment programs) were the costliest charges.center_img Charges for services associated with opioid abuse and dependence diagnoses vary widely across the nation, from an average per-service charge of $45 in Rhode Island to $263 in Iowa. At least part of the difference is that, in the states with lower charges, the most common services are less expensive ones, such as methadone administration. In the states with higher charges, the most common services are more expensive ones, such as office visits, drug screens, and naloxone.The increase in services for patients with opioid abuse or dependence diagnoses and the burgeoning cost for them affects our entire society and will likely require responses on various fronts. Medical schools, for example, may need to adjust their curricula to provide future physicians with the skills needed to prevent, recognize, and treat opioid abuse and dependence. Insurers may need to diversify or increase the number of providers in their networks to ensure sufficient access to treatment for opioid abuse and dependence.The findings in our new white paper will, we hope, help insurers, providers, legislators, educators, and policymakers make the best decisions possible.Robin Gelburd is president of FAIR Health, a national, independent nonprofit organization dedicated to bringing transparency to health care costs and health insurance information.FAIR Health breakdown of the costs of the opioid crisisFair Health [email protected] Aggregated across the nation, professional charges for services for patients with diagnoses of opioid abuse or dependence rose more than tenfold from 2011 ($72 million) to 2015 ($722 million). We estimated that allowed amounts (the maximum amount an insurer will pay for a covered health care service) grew more than thirteenfold during the same period, from $32 million in 2011 to $446 million in 2015. (A summary infographic of the findings is below.)Treating opioid abuse and dependence is expensive. In 2015, the average annual per-patient charges and estimated allowed amounts were more than five times higher for patients with diagnoses of opioid abuse or dependence than for those with any diagnosis. On average, private insurers and employers providing self-funded plans paid nearly $16,000 more per patient for those with diagnoses of opioid abuse or dependence than for those with any diagnosis.advertisement Among patients with opioid dependence, drug screening tests are the costliest health care charges. Kelley McCall/AP Related: Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster Tags health care costsmedical costsopioidslast_img read more

Pharmalot, Pharmalittle: Alkermes depression drug now looks promising, but will FDA bite?

first_img Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman Oct. 21, 2016 Reprints Gilead Sciences reported that an experimental drug showed promise in reducing liver scarring known as fibrosis in a midstage trial, TheStreet reports. The plan is to advance the drug, called GS-4997, into Phase 3 trials against the fatty liver disease known as NASH. But the drug failed to achieve the main goal of midstage trials for pulmonary arterial hypertension or diabetic kidney disease based on preliminary data analysisMerck reported that its Keytruda immunotherapy helped previously treated patients with advanced bladder cancer live longer in a late-stage study, prompting an independent monitoring panel to recommend stopping the trial early, Reuters tells us. The drug, along with rival Bristol-Myers Squibb’s Opdivo, is already approved to treat a common form of lung cancer.advertisement [email protected] @Pharmalot Ed Silverman PharmalotPharmalot, Pharmalittle: Alkermes depression drug now looks promising, but will FDA bite? center_img Alex Hogan/STAT Roche’s bid to follow its blockbuster Avastin cancer drug with a newer and better med suffered a setback after an experimental treatment failed in a study against metastatic colorectal cancer, Reuters writes. Roche hoped the drug, called vanucizumab, would win regulatory approval as a stand-alone follow-up for Avastin, after its US patent protection expires in 2019, and biosimilar versions become available.The UK’s National Institute for Health and Care Excellence switched gears and endorsed Bristol-Myers Squibb’s Opdivo for adults with advanced renal cell carcinoma after prior therapy, PharmaTimes says.Merck KGgA has merged its pharmaceuticals and consumer health care businesses as part of a major makeover of operations to India, according to The Economic Times.China Resources Pharmaceutical Group, the nation’s second-largest drug maker, raised $1.8 billion after pricing an intial public offering, below the midpoint of a marketed range, Bloomberg News writes. About the Author Reprints And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is somewhat ambitious. We plan to take Mrs. Pharmalot pear picking — yes, pears — and take a few naps when not catching up on our reader. And what about you? You could go door-to-door canvassing for one of the presidential candidates, which could get interesting. Find a quiet spot to enjoy the great outdoors. Or simply plan the rest of your life. Well, whatever you do, have a grand, old time. But be safe. Enjoy, and see you soon …The third time is the charm for Alkermes after a late-stage clinical trial found its experimental antidepressant demonstrated positive results, Reuters tells us. The drug, known as ALKS 5461, suffered a serious setback earlier this year when two other studies failed to achieve primary endpoints, sending its stock diving at the time, given that the company touted the drug as a potential blockbuster. This may be a test for the US Food and Drug Administration, since Alkermes hopes to win approval based on just one trial, Forbes adds.The European Medicines Agency has initiated an effort to proactively publish clinical trials data by releasing clinical reports for two drugs, Kyprolis and Zurampic, on a new online database, Regulatory Focus reports. The agency also added that it will publish the results of all trials submitted, regardless of whether the product is ultimately authorized, rejected, or withdrawn.advertisement Tags AlkermesGilead SciencesMerckpolicylast_img read more

Is the peer review system sustainable?

first_img Publishing fewer papers would be another means of rebalancing the load, as Tricia Serio, a biologist at the University of Arizona, argued in a post on the Conversation. “The first step is to reset and clearly state our standards for quality in both publishing and peer reviewing,” she wrote. “The outcome will certainly be fewer publications in biomedicine, but their individual impact will be greater.”Perhaps. But another solution would be to open the spigot for more and different forms of peer review. Sites such as PubPeer.com and PubMed Commons allow for peer reviewers to participate in ways that are less time-consuming but, in aggregate, far more valuable than the anonymous pre-publication process that happens these days. The old guard has resisted that trend, just as those who may not live until climate change has disastrous effects might ignore those realities, too. But they’re not the ones who will have to turn down the coming tsunami of peer review requests. By Ivan Oransky and Adam Marcus Nov. 18, 2016 Reprints Toho Co. Ltd./AP Related: The paper, published in PLOS ONE, included a few other interesting nuggets about the system. Researchers in the United States, for example, punch above their weight, reviewing a greater share of the world’s papers than they publish. On the other hand, Chinese scientists are net importers of reviewers’ time, publishing more globally than they review — twice as much, in fact. A general rule of thumb that many scientists use is to review one paper for every one they submit.As we and others have argued, peer review is a deeply flawed system, but one that deserves fixing, not scrapping. The latest study does nothing to change that view. It does, however, point to a few simple changes that could go a long way toward shoring up the structure.The first is paying reviewers for their time. Although the risk is that the “peer-review heroes” might get a windfall, it’s likely that many scientists who would like to review but feel they can’t spare the time will decide a few extra bucks is worth the extra work.That could bring about a class of professional reviewers — recently retired academics, perhaps, who bring a wealth of experience to the task, or consultants like Jonas Ranstam, who recently won an award as the world’s most prolific reviewer. What do Godzilla and scientific peer review have in common? Each by rights ought to be collapsing under its own weight. Yet somehow they stand.The good news — for movie fans and scholars alike — is that the behemoths appear to be stable for the moment. But, in the case of peer review, at least, it wouldn’t take much for the system to become perilously imbalanced.As it stands now, according to a new study, the pool of peer reviewers is able to keep up with the massive number of new papers published each year in biomedicine — more than 1 million, and climbing.advertisement The WatchdogsIs the peer review system sustainable? center_img Tags peer review We should reward peer reviewers. But how? Related: The amount of time reviewers spend on the task is, simply put, gargantuan: an estimated 63.4 million hours in 2015 alone, according to the authors of the study, or roughly 7,300 years’ worth of reviewing. If journals were to compensate those reviewers at a reasonable rate of $75 per hour, that’s on the order of $4.5 billion of labor.But the problem is, the distribution of labor is highly uneven. The researchers found that 5 percent of reviewers were responsible for nearly 30 percent of those hours. And that could lead to shoddier reviews, they wrote: “These ‘peer-review heroes’ may be overworked, with risk of downgraded peer-review standards.”advertisement Why our peer review system is a toothless watchdog last_img read more

Mobile dialysis could save lives in a disaster. But is there a cost to safety?

first_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED The calls started coming in the days after Hurricane Sandy. Flooded dialysis centers had shuttered across New York and New Jersey. Some patients and practitioners didn’t know where to turn. So they dialed Anita Chambers.“It was difficult to hear stories of patients being driven four to eight hours to find a center that could take them,” Chambers, said recalling the 2012 superstorm. “There were centers open that had all the patients in the day — seeing these patients in the middle of the night.” GET STARTED Mobile dialysis could save lives in a disaster. But is there a cost to safety? What is it? Natural disasters, such as Hurricane Harvey in Houston, can disrupt care for people who need dialysis treatment. Joe Raedle/Getty Images Log In | Learn More By Max Blau Sept. 21, 2017 Reprints Tags policySTAT+ What’s included? Health 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. 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.last_img read more

U.S. states are waging a civil war over donated livers. Will a new proposal finally resolve it?

first_img To solve organ shortage, states consider ‘opt-out’ organ donation laws The messages, many deeply personal, focus on the regional boundaries that divide life from death for patients with liver disease.“My partner passed away waiting for a liver transplant in Chicago,” one commenter wrote in support of a proposal to change the nation’s system of allocating livers. “Any move that can make access to transplant more equitable is a move in the right direction.”Another commenter, from South Carolina, disagreed: “I’m a 63 year old male that had a successful liver transplant on 5/9/14′ at MUSC Charleston SC…I truly believe residents of SC should receive these desperately need[ed] organs first, before shipping them to other regions.”advertisement Related: 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. @caseymross [email protected] Related: About the Author Reprints Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Please enter a valid email address. Some critics are even more pointed, alleging that the committee proposing the change is skewing information about MELD scores to support its position.“Members of [region 11] believe that data has been consistently manipulated throughout the conception of the proposal in a way that pushes favorable statistics to the forefront of the discussion while ignoring data that is detrimental to the proposal,” representatives of the region wrote in a comment letter. “The result of any proposal that is based on match MELD at transplant, and not waitlist mortality, is that livers will be reallocated away from vulnerable, rural populations to larger metropolitan areas where patients have far greater access to healthcare.”A UNOS spokeswoman said in a statement the data was generated by the Scientific Registry of Transplant Recipients and was presented in public meetings and broken out in the draft proposal. Heimbach said MELD score is not being used to skew the results of the analysis, but because it is the measure currently used to allocate livers. “Right now, we put people in order on the wait list based on the MELD score,” she said. “It determines the patient most likely to die in the next three months, and that’s the system we’re using.”She added that it is difficult to use waitlist mortality as a measure because of the variability in sickness level of people put on waitlists from region to region.Heimbach’s committee will meet Oct. 10 in Chicago to weigh the input and decide how to proceed — whether to alter the proposal, scrap it, or forward it to the full UNOS board for a vote in December. She acknowledged that the ongoing regional battle over the proposal is making progress slow and difficult.“It’s been a lot of years we’ve been trying to do this, and people do have a lot of concerns about change,” she said. “Patients’ lives are at stake and we’re worried about it. … We’re trying to make the best improvement we can, and it’s really hard.” Matching hearts — and kidneys and lungs. This website makes organ transplants in the US possible Hospitals are throwing out organs and denying transplants to meet federal standards center_img HealthU.S. states are waging a civil war over donated livers. Will a new proposal finally resolve it? Privacy Policy Related: Yet another wrote: “People in NY need to take care of people in NY. If they can’t, well they should move somewhere else.”All were writing in a response to a proposal that would change the geographic lines that determine access to donor livers in communities across the United States. The public comment period, set to conclude at midnight, has drawn more than 500 submissions from patients, advocacy groups, and physicians. Now a key panel must decide whether it should advance the plan toward a vote in December by the board of the United Network for Organ Sharing (UNOS).advertisement The effort is aimed at bringing a resolution, or at least a truce, in a long-running civil war over a scarce supply of donor livers in the United States. Its refugees are extremely sick patients who sometimes die waiting in a bureaucracy that determines their fate based largely on old boundaries that don’t take into account differences in supply and demand.More than 14,000 people are currently seeking liver transplants in the United States, according to UNOS. In 2016, 1,220 people died on waiting lists.The proposal to change the allocation system would broaden sharing of donated livers to a 150-nautical mile radius around the donor hospital, regardless of which organ region a potential recipient lives in. It would also award points to candidates based on their proximity to the hospital, to help minimize travel and logistical challenges.“The intent of the policy is to offer livers to the patient who’s got the most urgent need for a transplant,” said Dr. Julie Heimbach, a Mayo Clinic transplant surgeon who chaired the UNOS committee that devised the proposal. “One way to reach more of the urgent people at the time they need it is to share over a slightly bigger area.”Presently, UNOS allocates livers based on defined borders between 11 different geographic regions. That system has led to unequal access to organs, forcing some patients, especially those in high population areas, to suffer worsening illness and progress closer to death before receiving  transplants. The organization measures illness severity among patients using a MELD score (model end stage liver disease), with a higher number indicating increased severity. In 2016, the median MELD score at transplant in donor service areas across the United States ranged from 20 to 40, which translates to an estimated risk of three-month mortality without a transplant of 11 percent to nearly 100 percent, according to UNOS.Map of organ donation regions in the U.S. HHSMany factors play into those geographic imbalances, including varying demographics and rates of disease, different rates of organ donation, and different practices of transplant centers and patients’ access to care.But if the mathematics of the problem are complicated, the politics are even more so. Transplant centers want to protect their ability to treat their patients, so the existing regional boundaries have created entrenched interests that are resistant to change. Reform efforts are further complicated by socioeconomics, and differences in access between rural and urban populations. By Casey Ross Oct. 2, 2017 Reprints Casey Ross Leave this field empty if you’re human: Like proposals that came before it, the new solution is generating sharp disagreements along those fault lines.Indiana University Health, that state’s largest hospital system, wrote in its comment letter that the proposal would harm Indiana residents with liver disease and reduce the number of transplants. It also argued that it would unfairly ship livers to other regions that have not had the same success in increasing organ donation and using those organs effectively.“The solution should not be moving livers from the Midwest and South to these large urban areas like New York, California and Massachusetts,” wrote Dr. Jonathan Fridell, a transplant surgeon at IU Health. “This proposal only serves to reward those locations that underutilize existing resources at the expense of those locations that have been successful in reducing their wait list through aggressive organ transplant techniques.”Fridell added: “We are also gravely concerned that this proposal has the potential of taking livers away from patient populations that are disproportionately low-income and underserved.”The region that includes Indiana — region 10 — voted against the proposal, as did region 11, comprising Kentucky, South Carolina, North Carolina, Tennessee, and Virginia.Region 7, which includes Illinois, Minnesota, North Dakota, South Dakota, and Wisconsin, voted in favor. Also in favor was region 9, covering New York and western Vermont. Representatives of that region argued in a comment letter that the proposal does not go far enough.“Region 9 is recommending changes to distribute livers more broadly and with fewer constraints,” the letter said, noting that the region voted to expand the sharing radius to 250 miles. “Modifying the constraints to share more broadly will benefit all areas.” Ariana Cubillos/AP Whether the vast divide between these regions can be bridged is an open question.Earlier this year, UNOS, which operates the Organ Procurement and Transplantation Network under contract with the federal government, shelved a prior effort to create eight new regions designed to ensure more equal sharing of livers. Eight of the 11 regions voted against the proposal, which was finally abandoned in May.The latest proposal was developed with input from a group of liver surgeons and other stakeholders that provided recommendations on how the system should be changed. It seeks to address concerns that arose in response to the eight-region proposal, which many complained was based on a flawed scoring system that could lengthen wait times in some areas and force transplant centers to close.Instead of redrawing geographic boundaries based on mathematical analysis of supply and demand, the current proposal seeks to keep the regions but soften their borders to allow for more sharing across the lines.But opponents argue the plan places too much emphasis on a patient’s MELD score. They say the solution should be to focus more directly on increasing organ donation rates and transplantation practices in parts of the country with shortages, rather than re-drawing the regional borders.“This policy is attempting to change allocations for the entire nation, which isn’t entirely broken, to fix two parts of the country,” Fridell said, referring to the East and West coasts. “That’s why the vast majority of the country has been opposed to this policy.” Tags patientslast_img read more

A new microscope spies the raucous beauty within living cells

first_imgWhite blood cells on a search, destroy, and tidying-up mission inside the inner ears of developing zebrafish embryos. T. Liu et al./Science 2018 Human breast cancer cells, rolling like blood-borne tumbleweeds, commando-crawling through a tight vascular honeycomb, and jaggedly oozing though an opening in a vessel wall. T. Liu et al./Science 2018 A cotton-candy-colored cavern of blooming neurons inside the developing spinal chord of a zebrafish. (You can glide through as neural projections, called axons, scuttle by your feet in both directions, and cell bodies bob and sway above your head like festive party balloons.) T. Liu et al./Science 2018 Betzig’s research is outlined in a new study, published Thursday in the journal Science. An engineer by training, he said the research was inspired by a “very low attention span” for his own microscopes.“Pretty much every microscope I do is in answer to my acknowledgement of the limitations and the frustrations that I had with the last microscope I did,” he said. (Betzig shared the Nobel Prize in chemistry in 2014 for a microscope he’s already mostly moved on from.)The new microscope, called a lattice light sheet microscope with adaptive optics, has solved for most of those frustrations.“It’s an amazing achievement and something that Eric has been targeting,” said Catherine Galbraith, an associate professor at Oregon Health and Science University, who was not involved in the research, but who has worked with Betzig in the past. Maybe you remember “the cell” from your high school biology book? A smooth, brownish blob, cut away to show the supposedly neat and orderly components, arranged just so.It was an uncomplicated look inside the powerhouse of life itself. It was also not entirely accurate.“That’s a caricature of what the cell really is,” said Eric Betzig, a group leader at the Howard Hughes Medical Institute’s Janelia Research Campus in Ashburn, Va. “The cell is this incredibly dynamic place where everything is moving — it’s all about kiss and run kind of stuff.”advertisement Leave this field empty if you’re human: Betzig is working to commercialize the technology in the coming years, but he fears that even if there was a version a scientific lab or a pharmaceutical company could buy, there would still be a big data problem. The microscope doesn’t just spit out pretty video ready for posting to your favorite science social media account. What you get out of the machine is an unholy pile of flat images that need to be laboriously re-stacked through space and time.Once you get through the pain and anguish of doing that, the slow reveal, said Betzig, blows away the researchers he’s working with, without fail. But many are left “crying a month later when they don’t know how to deal with 10 terabytes of data.”He’s trying to solve that data problem with his feet. This summer Betzig will move his lab to the University of California, Berkeley, in part to try to tap local tech expertise.“I’m going everywhere through the Bay Area banging the drum, trying to marshal troops together to work on it because, face it, and I’m just too goddamned old to solve the problem myself.”If he doesn’t succeed? Betzig is toying with the idea of harnessing his microscope to create salable art in his retirement. Think George W. Bush, the oil painter, just with lasers and tissue samples. Privacy Policy A fly through the individual cells in a zebrafish eye, accomplished after imaging with a new microscope system, called the lattice light sheet with adaptive optics. The different colors represent the different specialized structures within the living cells. T. Liu et al./Science 2018 In the LabA new microscope spies the raucous beauty within living cells Related: The thin plane of laser light is useful in illuminating living cells because concentrated light is fast and gentle enough to capture action without cooking cell innards, while also helping to preserve the fluorescent dyes used to label structures within the cell.That lattice-light sheet alone can’t see very far beyond the very surface of a cell, however. “If you look at any depth inside of anything like the zebrafish or something like that, it’s too turbid to see,” said Betzig. “It’s just a mess.”To deal with that inner mess, the researchers used a technique inspired by the distant stars. Astronomers use something called “adaptive optics” to cancel out the visual distortions of our turbulent atmosphere. They harness a “guide star” (a bright, nearby star or an artificial laser shot skyward) as a predictable reference point.Scan laser guide stars into a specimen, and you have a way to track and de-mess the light’s bends and twists as it moves through living tissues. A view of the adaptive optics corrections applied to the skeletal rod supporting a growing zebrafish. T. Liu et al./Science 2018 Betzig described first seeing cells with only the lattice sheet technology in 2014 as “watching a lion in a zoo.” With the new, combined scope, he’s now “watching the lion on the savanna.”Galbraith takes the metaphor even further: “You’re not just watching it on the savanna, you’re lying in wait on the savanna to see what actually happens.” She said that for microscopists, the fundamental challenge has always been to observe and not disturb, and that the new microscope goes a long way toward doing that.The next step is making more than one working version of it.“When you see these movies, you just say, ‘Oh my goodness, I want to study this,’” said Jennifer Lippincott-Schwartz, a senior group leader at Janelia and a colleague of Betzig’s. “But a key aspect of whether it will be embraced, is how quickly people can have access to these microscopes.” She added: “They’re not easy to build.”center_img By Jeffery DelViscio April 19, 2018 Reprints Betzig, along with collaborators at six other institutions in the U.S. and Europe, has developed a new microscope that ditches the caricature, capturing the riotous action inside living cells. It does so in part by using a thin plane of laser light to illuminate cells within a subject — and a trick plucked from the stars to unscramble the light that comes back.The result serves up visual treats, including:advertisement Tags research WATCH: Your mouth is full of bacteria blooming. And it’s beautiful NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Please enter a valid email address.last_img read more

U.K.’s Corbyn promises to form a government-owned drug company to lower prices

first_imgPharmalot Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Ed Silverman In a potential challenge to the pharmaceutical industry, Jeremy Corbyn promised that if his opposition Labour Party took control in the U.K., he would form a government-owned drug company to supply the National Health Service with lower-cost generics.“We will redesign the system to serve public health – not private wealth,” he told a party conference on Tuesday. “We’ll tell the drug companies that, if they want public funding, then they’ll have to make their drugs affordable for all. And we will create a new publicly owned generic drugs manufacturer to supply cheaper medicines to our NHS, saving our health service money and saving lives.” Jeremy Corbyn, leader of the Labour Party Dan Kitwood/Getty Images 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 Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot What’s included?center_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What is it? Log In | Learn More About the Author Reprints By Ed Silverman Sept. 25, 2019 Reprints [email protected] U.K.’s Corbyn promises to form a government-owned drug company to lower prices Tags pharmaceuticalsrare diseaseSTAT+last_img read more