Biden staff to cancer researchers: Tell us what we can do quickly

first_imgPoliticsBiden staff to cancer researchers: Tell us what we can do quickly A Biden aide declined to talk about the specifics of the meeting, but said the vice president was “using his ability to convene to bring together components of the cancer community, and sees great promise in genomics, immunotherapy, and combined therapies.”One idea that both sides floated during the meeting, which ran 20 minutes longer than planned, was the national open-access data-sharing initiative for scientists and institutions. Biden’s staff was “incredibly interested” in the idea, according to Baselga.“I think we all concluded that perhaps what would benefit the field the most is to build [the] open-access data-sharing initiative,” he said. “We could learn collectively how these tumors behave, what kind of therapies they respond to.”The researchers also told Biden’s aides that they believed the federal government should pay for the next generation of gene sequencing, which could help develop personalized treatments for cancer patients.“These are the things that are feasible,” Baselga said. “They can be done. They would be very impactful.” Related: Biden’s staff was “asking concrete questions,” he said, on how a data platform would be structured and funded.But beyond the minutiae, Biden’s aides were also clearly interested in having the vice president play an aspirational role in the fight against cancer.In May, Biden’s son Beau Biden died of brain cancer at the age of 46.They wanted to know how they could “use the power of both [the vice president’s] personality, as well as the power of what he and his family have been through, as well as the office to move things forward,” according to Dr. George Demetri of the Dana-Farber Cancer Institute, who also attended the meeting.They were interested in “how we can break down silos,” Demetri said, with the data initiative idea being one tangible way to pursue that goal.“I think most of us came away feeling really energized,” he added.Biden’s “moonshot” initiative started with his statement in October, in announcing that he would not run for president, that he wanted the country to pursue a “moonshot” to cure cancer. According to a Biden aide, the vice president and his staff have held dozens of meetings like Friday’s to gather input about how to improve cancer care and research.This story was updated with comments from Biden’s office. Joe Biden’s aides tell researchers they want to find cancer initiatives that could have a quick impact during his last year in office. Mark Humphrey/AP WASHINGTON — Vice President Joe Biden is looking for ideas for his cancer “moonshot” initiative that would have the quickest possible payoff, according to leading researchers who met with his staff on Friday.The questions the cancer researchers got from Biden’s aides suggest that they realize big, breakthrough cancer treatment discoveries could take years — so they’re putting their immediate focus on smaller initiatives that they can actually get done during his final year in office.The researchers suggested two possible quick-payoff initiatives: a data-sharing program that would allow researchers to compare notes on how tumors respond to different therapies, and a federal investment to make new progress in gene sequencing.advertisement “They are on a time crunch,” Baselga said. “They know that there is one year left of his administration. They had a sense of urgency.” Joe Biden pushed Congress for big boost in cancer research funding Joe Biden calls for ‘moonshot’ to cure cancer Tags cancerJoe Bidenmedical researchpolicy Top Biden policy staffers met for 80 minutes in the vice president’s office with scientists from the American Association for Cancer Research. One clear takeaway was that the vice president’s staff is looking for something concrete they can do in Biden’s final year, Dr. José Baselga, the president of the organization and chief medical officer at the Memorial Sloan Kettering Cancer Center’s Memorial Hospital in New York, told STAT.A big part of their message, according to Baselga, was: “Let’s leave aside discovery for a second … This vice president has a year left. What could be done that could be impactful?”advertisement By Dylan Scott Jan. 8, 2016 Reprints Related:last_img read more

Inside the race to diagnose cancer from a simple blood draw

first_img Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Please enter a valid email address. Megan Scudellari BOSTON — It’s a medical puzzle that has snagged the attention — and the money — of Bill Gates, Jeff Bezos, and venture capitalists across the nation: Is it possible to diagnose cancer from a simple blood draw?Surgical biopsies are the norm, but they’re invasive, expensive, and carry the risk of infection. So investors have poured hundreds of millions into the goal of developing “liquid biopsies.”There has been some progress: Blood analysis is now used to identify the best treatments for certain cancers — and to update treatments as the cancer mutates. But so far, no one has scored the ultimate success: diagnosing incipient cancer from a vial of blood drawn from a patient who looks and feels perfectly healthy.advertisement Related: Liquid biopsy researchers Dr. Daniel Haber and Mehmet Toner in their Boston lab. Josh Reynolds for STAT Some 38 companies in the US alone are working on liquid biopsies. Most are trying to analyze blood for fragments of DNA shed by dying tumor cells.In a lab overlooking Boston Harbor, an unlikely duo is taking a different path.advertisement Cambridge-based Exosome Diagnostics just snagged $60 million in investor funding and has already released a lung cancer liquid biopsy to detect tumor mutations via those vesicles. The company has three other tests scheduled for release this year, some of which co-analyze exosomes and ctDNA as a way to gather information from both living and dying cancer cells in the body.Haber chalks up the industry’s enthusiasm for cell-free tests to how complicated and expensive it has been to isolate rare cells from the blood. But that is changing, he said.“We’re on the cusp now of having a very standardized, affordable technology that will change the whole equation again,” he said.It’s been 10 years since Haber and Toner started this journey.“It’s time to renew our vows,” Haber joked, turning toward his friend. “You look good for an old guy.”Toner laughed, adjusting his round, black spectacles.Janssen Diagnostics, which funded the research, is pleased with the iChip emerging from their lab. “The engineering is almost ready,” Villacian, the chief medical officer, said.Though the grant has now run out, Janssen and MGH are now in talks about starting a biotech company to move the technology toward commercialization, Haber said.Currently, Haber and Toner are designing several large clinical trials to demonstrate when and where the iChip will be most useful. Their plans should be ready in, oh, two or three more cross-country flights. Companies seek to diagnose cancer from a blood sample The most current device, the “iChip,” is made of thin, lightweight plastic etched by a laser with microfluidic grooves just visible to the naked eye. This time, the chip is round, due to the fact that it is manufactured on old CD equipment.Blood first passes through a series of short rods on the chip, like a miniaturized pachinko machine. Smaller objects move more quickly, bouncing from post to post, so red blood cells and plasma are quickly sorted out and expelled as a red fluid.Chunky white blood cells and tumor cells, on the other hand, move more slowly through the channels and are funneled single-file into the next section of the chip. Here, the white blood cells, previously labeled with magnetic beads, are removed via a magnetic field and also expelled, as a milky white solution.At last, the unmarked, untagged tumor cells drip into a pristine test tube. With those cells, the world is Haber’s oyster.Vials of blood and tumor cells shuttle back and forth in the lab he and Toner share in MGH’s research facilities at Charlestown Navy Yard. They use the material in a dozen ongoing studies, studying how hormonal drugs affect prostate cancer, how immunotherapy alters tumors, and how breast cancer mutates in response to chemotherapy.“The information content from whole cells and the ability to look at how each cancer cell is different from the other is very powerful,” Haber said.A pair of machines in Haber and Toner’s lab that screen blood through a filter to extract whole tumor cells. Josh Reynolds for STAT  The fragment hypothesisBut as more researchers and biotech companies enter the field, most of them have shied away from whole cell capture. Instead, the focus is on small DNA fragments shed from dying tumor cells, called circulating tumor DNA (ctDNA).One study found that ctDNA was detectable in the blood of anywhere from half to nearly 90 percent of patients, depending on the type of cancer. The study also found that the ctDNA could be used to identify clinically relevant gene mutations, which could help oncologists select which specific medication might work best against a given tumor.California-based biotech Guardant Health — formed in 2012 and recent recipient of $100 million from eager investors — uses that technique to search for 70 actionable mutations in solid tumors.Yet another novel approach is also making waves in the field: Detecting tumor mutations via DNA, RNA, and proteins isolated from tiny vesicles called exosomes that are expelled by living cells. Shoddy biopsies deny cancer patients a shot at personalized treatment In the LabInside the race to diagnose cancer from a simple blood draw And last fall, federal regulators upbraided San Diego-based Pathway Genomics for selling a liquid biopsy kit that purported to screen healthy, at-risk individuals for early signs of cancer. The Food and Drug Administration called it “a high risk test that has not received adequate clinical validation and may harm the public health.”Nonetheless, Gates and Bezos recently teamed up with Illumina, a leading DNA sequencing company, to launch yet another liquid biopsy startup — this one ambitiously called Grail.The field is such a roller coaster that Haber and Toner make a point of being cautious and methodical.“You find strange things, you question yourself, and you test it over and over again to be sure it is right,” Haber said.Flipping haystacksIn 2006, Haber was fresh off identifying a mutation that makes lung tumors susceptible to a particular class of drugs, while Toner was testing a microfluidics technology to sort rare cells, such as fetal cells in the blood of a pregnant woman.Each had worked at Massachusetts General Hospital for over a decade without ever crossing paths, until Dr. Kurt Isselbacher, founding director of the MGH Cancer Center, brought them into his office for lunch and suggested they work together to capture tumor cells in the blood.At the time, there was one FDA-approved liquid biopsy on the market, Janssen Diagnostics’s CellSearch, a device that counts the number of circulating tumor cells (CTCs) in the blood of patients with metastatic breast, colon, and prostate cancers to predict a good or bad prognosis.But little was known about CTCs in the blood. How many were there? From what types of tumors? Could they be efficiently separated out and analyzed?“The biology of these cells was a mystery,” said Toner. Leave this field empty if you’re human: Flying without a compass, Toner and Haber worked painstakingly on the same idea that had been successful with CellSearch: “positive selection” or actively pulling cancer cells out of the blood by labeling them with sticky, specific molecules called antibodies.The first iteration of their test was a thick, rectangular silicon chip. It worked: They published a paper showing it could detect tumor cells in the blood of patients with lung, prostate, pancreatic, breast, and colon cancer. But the technology was prohibitively expensive, more than $1,000 per chip, and painfully slow — it took several days to identify one tumor cell.CTCs, it turns out, are extremely rare in the blood — an estimated one in a billion.Haber and Toner brainstormed alternative approaches from 40,000 feet in the air. Both men frequently travel to conferences and talks, so when they fly together, they’re sure to get aisle seats across from one another. That way, they can pass ideas back and forth on — what else? — cocktail napkins.“We solve a lot of problems that way,” said Toner with a happy shrug.Unless the flight attendants get in the way, Haber added pointedly.Soon, they had a solution. “Since we know everything about blood cells, we flipped the problem,” said Toner. “Instead of going after a needle in the haystack, we decided to get rid of the haystack.”In other words: They’d filter out all the healthy components of the blood and look for tumor cells left behind.It was about this time that Johnson & Johnson stepped in and offered validation — and a big check — for the duo’s efforts, committing $30 million over five years to construct the next generation of the technology. Please enter a valid email address.center_img The newest cancer therapies don’t work on everyone. Now, doctors have a clue why By Megan Scudellari March 21, 2016 Reprints Privacy Policy Related: Related: Mehmet Toner and Dr. Daniel Haber — a Turkish bioengineer and a Jewish geneticist — joined forces a decade ago, in a partnership forged over tuna sandwiches. While other scientists scan blood for scraps of tumor DNA, Toner and Haber filter out all the healthy components of the blood — then scoop up any whole tumor cells left behind.The process is costly and time-consuming. And their peers mock it as hopelessly old school.Mention the idea of capturing whole tumor cells to venture capitalists and “they roll their eyes,” said John Boyce, chief executive of Exosome Diagnostics, which recently launched a liquid biopsy test to identify lung tumor mutations.But Toner and Haber are undaunted. They’re convinced whole cells will give doctors valuable information about cancer. A fragment from a dying tumor cell, Haber said, “doesn’t tell me anything about the biology of the living tumor.”Haber and Toner use a filter made from old CD equipment in their research into liquid biopsies. Josh Reynolds for STAT A tumultuous marketIf liquid biopsies work as hoped, the market in the US alone is projected at $29 billion, according to a 2015 report from investment bank Piper Jaffray.“It is the one area of oncology you see featured at every single conference,” said Dr. Jorge Villacian, chief medical officer at Janssen Diagnostics, a subsidiary of Johnson & Johnson, which has the sole FDA-approved liquid biopsy on the market. “There’s a great deal of enthusiasm.”And a great deal of drama.On-Q-ity, a liquid biopsy startup based in Waltham, Mass., folded in 2013. One of its investors said the technology would likely not be market-ready for another five to 10 years. Privacy Policy [email protected] Startup backed by big names aims to detect early cancer in blood Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. About the Author Reprints Related: Tags biopsycancerdiagnostics Leave this field empty if you’re human: last_img read more

Matching hearts — and kidneys and lungs. This website makes organ transplants in the US possible

first_imgHealthMatching hearts — and kidneys and lungs. This website makes organ transplants in the US possible Privacy Policy Alex Hogan/STAT Can a president really jump the line for an organ transplant? By Eric Boodman June 10, 2016 Reprints Tags organ transplantsurgerytechnology The man died in Pennsylvania. It was a stroke in the middle of the night.Within hours, the news had traveled across the country. Phones vibrated and pinged and rang. Metallic automated voices gave brief reports. Those receiving the news wasted no time. They were soon poring over the man’s medical history — diabetes, high blood pressure — and studying the function of his heart, his liver, his pancreas, and his lungs. With a few clicks, some would even be able to inspect the glistening surface of his kidneys.These were transplant surgeons, scrambling to determine whether these organs in Pennsylvania could give their sick patients new life. But part of that work had already been done for them — by a website.advertisement Related: Eric Boodman Please enter a valid email address. Called DonorNet, it is part of the online system run by the United Network for Organ Sharing, the nonprofit that oversees all transplants across the country. DonorNet can seem like an ever-growing library of tragedies — in late April, it held records of 3,945 natural deaths, 1,323 car accidents, 905 suicides, and 414 homicides.Yet hidden behind the graphic details of gunshots and strokes and asphyxiations is a medical tool as finely tuned as any scalpel or ultrasound.advertisement About the Author Reprintscenter_img UNOS has since pared back the outreach, and surgeons have gotten used to the metallic, Siri-like voice of DonorNet.As Roger Brown, the director of the UNOS organ center in Richmond, Va., put it, “When they hear that voice, they know what they need to do.”They need to wake up, or stop their cars, or step out of their meetings. They need to log immediately onto DonorNet to review lab results and life histories. They have an hour to decide whether this organ is right for their patient.“It’s a game of stories, matching the donor story to the recipient story,” said Dr. Joshua Weiner, a surgical resident at New York Presbyterian Hospital.Most donors have been declared brain dead; they’re on ventilators to keep the organs pumping in their bodies until it’s time for each one to be transported to another operating room, where the recipient will be ready and waiting. But sometimes — especially in the case of kidneys — the organs have already been removed, and transplant surgeons can examine pictures online.A few weeks ago, Dr. Nahel Elias, director of kidney transplantation at Massachusetts General Hospital, clicked on a link to check out a kidney. It turned out it wouldn’t have functioned well enough to transplant: it was covered in cysts. They looked like snails clinging to a seaside rock. Related: Leave this field empty if you’re human: For contrast, Elias clicked to another patient’s organ. “This is a healthy kidney,” he said. “It’s smooth and pink. It only has a little bit of fat.”Another few clicks, and his screen filled with the image of someone’s liver clutched in a gloved hand. “That’s a nice looking liver,” he said. “It’s smooth, it has sharp edges, it doesn’t have too much fat, so the color is more toward that burgundy purple, not yellowish.”Everyone involved in the organ donation process seeks to rigorously protect patient privacy. They would not give details about the Pennsylvania man’s life or share what happened to his organs.For his part, Elias tries not to think too much about the donor. It’s “always a sad story,” he said. Instead, when he gets pinged by DonorNet, he focuses on the organ on his screen — and on whether he can use it to save a life. Its algorithms match the organs of those who’ve just died to those who are on the waiting list, and they are constantly being revamped, even as they handle more and more traffic. Last year, those algorithms facilitated 24,980 transplants — up nearly 9 percent from 2013.The online system takes into account much more than just body size and blood type when connecting available organs to potential recipients. It also calculates how far an organ would have to travel to reach a patient — and how long it could survive doused with preservative fluid and packed in sterile ice, or hooked up to a pump.“For hearts, it’s four hours or so. For lungs, it’s six, eight hours tops, or maybe 10. For livers, it’s 12 to 14 hours max,” said Christopher Curran, the director of organ operations and surgical recovery at the New England Organ Bank. “We’ll ship kidneys around the country, and they can tolerate 24 to 36 hours outside the body — for good kidneys.”With more than 120,000 patients waiting for a transplant — from preemies to grandparents — geography is just one of many variables in the equation. The algorithm also takes into account a slew of details about their lives and health. How do you ask grieving parents to donate their son’s penis? Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. @ericboodman “It used to be, many years ago, the primary factor was waiting time. In simplistic terms, the people who had waited the longest got the highest priority,” said Rob McTier, who helps manage the online system at the United Network for Organ Sharing, known as UNOS.Now, those algorithms have become a lot more intricate. And every change is the result of years of fierce debate among surgeons, patient advocates, and transplant policy makers.In December 2014, for instance, the kidney algorithm was overhauled. Those whose immune systems are likely to reject most organs are now given priority when the rare compatible kidney becomes available. Another change: The organs in the best shape now tend to go to those patients likely to survive longer, so that the recipients won’t need another transplant down the road.“That took about 10 years to work through the comment processes,” said Alex Tulchinsky, the chief technology officer at UNOS.The organization is now working on changes to the liver algorithm to smooth out wait times, which now vary greatly by region.It isn’t just the algorithms that have been tweaked. Before 2007, someone had to call the surgeon responsible for each patient deemed a potential recipient of an organ, one after the other, until one of them said yes.Now, all of those calls go out automatically, at the exact same time.The transition was hardly seamless; at first, DonorNet offered the same organ to too many surgeons at once, “waking people up in the middle of the night six times a night for an [organ] that was never going to come to them,” said Dr. David Gerber, the chief of abdominal transplant surgery at the University of North Carolina.“Back then if you brought up the word DonorNet, you had to step back because you were going to get some vitriol,” Gerber said. [email protected] last_img read more

AstraZeneca loses court battle to prevent generic versions of Crestor

first_img Tags AstraZenecaCrestorgeneric drugs Ed Silverman AstraZeneca sues FDA to prevent generic versions of Crestor A federal judge late Tuesday refused to issue an order that would have blocked several companies from selling generic versions of the Crestor cholesterol pill in the US.The decision is a blow to AstraZeneca, which last month filed a lawsuit against the US Food and Drug Administration in hopes of thwarting generic competition to its blockbuster drug, a $5 billion seller last year. The drug maker claimed the agency was about to illegally broaden the indication for the drug and, as a result, unfairly permit low-cost copycat versions of Crestor.Now, several companies — including Sandoz, Mylan Laboratories, Apotex, Aurobindo, and Sun Pharma — are poised to sell generics. In reaching his decision, US District Court Judge Randolph Moss, who is based in Washington, D.C., rejected an argument from AstraZeneca that it was entitled to seven years of additional exclusivity to sell Crestor in the US market. The FDA, meanwhile, rejected a citizen’s petition filed by AstraZeneca seeking to halt generics.advertisement By Ed Silverman July 20, 2016 Reprints In its lawsuit, AstraZeneca insisted that the FDA’s interpretation of the law would pose a safety risk if applied to Crestor. The drug maker contended that any generic label could render generics potentially dangerous. The drug maker argued that a doctor may still prescribe a generic for HoFH, but choose an incorrect dosage since generic labeling would not contain the same information as Crestor.The US Department of Justice, however, belittled that argument. “This case is not about the medical needs of a small population of pediatric patients with a rare disease,” the Justice Department wrote in court documents. “It is about AstraZeneca’s profit-driven desire to substantially extend its virtual monopoly on one of the world’s most popular medicines.”A delay in generic versions of Crestor may have placed patients at a disadvantage. A recent study in JAMA Internal Medicine found that a six-month delay in the availability of generic versions of the Lipitor cholesterol pill prevented consumers from benefiting from lower out-of-pocket payments. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] As we reported previously, AstraZeneca last May won FDA approval to sell Crestor to treat children with a genetic disorder called homozygous familial hypercholesterolemia or HoFH, which causes very high cholesterol. And thanks to the Orphan Drug Act, the company was awarded an extra seven years of marketing exclusivity, but only for treating this particular rare, or orphan, disease.However, the drug maker maintained that any generic version must include all pediatric labeling information that was approved for Crestsor. And so, facing an expiring patent, AstraZeneca filed its lawsuit over concerns the FDA would, instead, rely on a decision made last year in which generics were allowed to exclude certain information in such situations, so long as a safety risk is not created.That case involved Otsuka Pharmaceuticals, which tried to prevent generic versions of the Abilify antipsychotic. Essentially, AstraZeneca mimicked the Otsuka playbook, which involved filing a lawsuit claiming the FDA was illegally widening the market for the drug and unfairly opening the door to generic competition. Ultimately, Otsuka did not succeed and the FDA approved generic versions. Sanders, other lawmakers urge FDA approval of generic Crestor center_img At issue was a controversial maneuver AstraZeneca used to try to maintain a monopoly on Crestor through 2023. The drug maker accused the FDA of illegally interpreting federal law governing product labeling and sought to prevent the agency from broadening the indication for Crestor. Patent protection for the drug expired earlier this month, which is why the company sought a temporary restraining order.advertisement @Pharmalot About the Author Reprints Related: An AstraZeneca spokeswoman wrote us that the company is disappointed with the ruling, but is “currently assessing” its options. PharmalotAstraZeneca loses court battle to prevent generic versions of Crestor Kirsty Wigglesworth/AP Related:last_img read more

Improving health care with the simple act of listening

first_img About the Author Reprints First OpinionImproving health care with the simple act of listening Privacy Policy Please enter a valid email address. [email protected] Dr. Olveen Carrasquillo conducts a checkup at the University of Miami Miller School of Medicine. Joe Raedle/Getty Images The idea that more is better has many Americans going from doctor to doctor to doctor, getting test after test, and becoming increasingly anxious about our health while increasing the cost of health care.We’ve been told that a big problem with health care is inefficiency and waste. (It is.) We’ve been told that old fashioned doctoring results in huge variations of care. (It does.) We’ve been told that constant electronic nudging will make doctors better. (Maybe.) Doctors are being told they must make their productivity numbers to keep their jobs and prove they are efficient. (Sad but true.)Pioneering cardiologist and Nobel Peace Prize winner Dr. Bernard Lown has said that the usual rules of efficiency are inverted in medicine. The more time a physician spends with patients, the more efficient he or she becomes. Listening costs next to nothing, and so is infinitely more cost-effective than drugs and devices. Listening promotes healing and causes no harm. In fact, it’s the bedrock of a genuine trusting relationship — something everyone wants from their doctors and nurses. In the tone of voice, in the subtlety of the pattern of pain, in getting the sequence of events right — that’s how a correct diagnosis is made and the person emerges from the patient. If all health care providers listened better, we would save billions of dollars and transform the system. So why don’t we have the time we need to listen?Because clinicians have been put on a treadmill driven by the pitiless demands of a false concept of efficiency. Money has replaced quality care as the measure of health care. The idolatry of the market is driving a race among hospitals, insurers, and manufacturers to get bigger and bigger.To fix health care, we need a genuine democratic dialog. To start that, our society needs a massive dose of listening to understand what really matters to patients and communities.This week, close to a thousand doctors, nurses, and patient activists are making extra efforts to highlight the lost art of listening as part of Right Care Action Week, which is sponsored by the organization I run, the Lown Institute. In order to listen to Americans talk about their own health and the health care they receive, they will set up listening booths on busy streets, participate in health care “story slams,” and call patients to ask what worries them most. Tags health carelisteningRight Care Action Week @DrVikasSaini She’s calling for a health care revolution. The radical first step: listen to patients Leave this field empty if you’re human: If listening matters in the exam room, it matters even more in our society.In the early 1960s, a decade into the civil rights movement, students went to Mississippi to organize partly because it was the most difficult place in which they could imagine being successful. When they arrived, they met with scores of leaders in the churches and NAACP chapters. They solicited ideas from ordinary local people like sharecroppers and farm laborers. It was through this months-long process of intensive listening that the students learned what people wanted from the civil rights movement: “What we want is to be able to vote.” The next phase of the movement was born, and together they made history.We face a similar moment today in our efforts to fix health care. To make a difference, we must first identify what matters most to patients, health care providers, and communities. To do this, we must all learn to ask open-minded questions and listen carefully. That’s why doctors, nurses, students, patients, and community leaders are listening hard across the country this week. It’s the necessary prelude to action.Vikas Saini, MD, is a cardiologist and president of the Lown Institute in Brookline, Mass., which sponsors Right Care Action Week. Related: By Vikas Saini Oct. 17, 2016 Reprints Vikas Saini In medical school, doctors-in-training are taught that 85 percent of a diagnosis comes from a careful history, and another small portion comes from the physical exam. But these days we are so busy testing that it’s easy to miss the subtle — and sometimes not so subtle — indicators of a patient’s health. It’s certainly quicker to order the test, get some numbers, and then treat the numbers instead of the patient.The doctor-patient visit is becoming a commodified transaction rather than a collaboration. Clinical life feels more and more like sprinting on a hamster wheel, chasing unproven metrics to get graded on “quality.” It’s no wonder that burnout is exploding among physicians across the country.advertisement Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Ten years ago, a woman with a heart murmur who experienced a bout of dizziness saw me for a second opinion. Another cardiologist had told her she needed open heart surgery to replace a valve in her heart. The idea of surgery terrified her, in part because she believed she would lose her job if she took time off from work. She knew she needed a new valve at some point, but hoped to put it off until she retired in eight years.Her cardiac ultrasound looked horrible and, based on that alone, qualified her for surgery. But the more I listened to her story, the more it didn’t add up. Her dizziness had been fleeting, likely from a virus. She was extremely active, exercising vigorously several times a week with absolutely no symptoms. Her pulse wasn’t worrisome, nor was sound of her heart murmur through the stethoscope. I asked her to do a treadmill exercise test, which she passed with flying colors.So I ignored the ultrasound results and listened to what my patient and her body were telling me. When I said it would be perfectly reasonable for her to wait on surgery and check in with me every six months, she overwhelmed me with her gratitude and relief, like I had commuted a death sentence. This year, 10 years later, she finally had her valve replaced.advertisementlast_img read more

Fake news invades science and science journalism as well as politics

first_imgThe WatchdogsFake news invades science and science journalism as well as politics Related: By Ivan Oransky and Adam Marcus Dec. 30, 2016 Reprints Related: From President-elect Donald Trump’s tweets to Facebook fabrications, 2016 has been the year of “post-truth.” Fortunately, we have science to rescue us from fake news, right?Maybe not. Just as some political reporters were taken in by fake news during the election cycle, science journalists also fell for their share of it this year. Examples abound on HealthNewsReview, which rates coverage of medical reporting. These include the breathless and most likely incorrect revelation that actor Ben Stiller skirted death by getting a screening test for prostate cancer. Or Sheryl Crow’s nuance-free and deeply misleading promotion of 3-D mammography for the imaging company Hologic. Or the Cage Match of Credulity, in which Dr. Oz “interviewed” then-candidate Trump about his health, a journalistic farce that redefined the word softball.Science itself never falls victim to this sort of distortion though, does it? We wish that was so. Take, for example, a conspiracy theory about cloud trails from jet planes that was published in a peer-reviewed journal. How about a study linking vaccines to autism long after such a connection had been thoroughly debunked? That one was published in a public health journal. Or this fake news whopper: HIV doesn’t cause AIDS. A peer-reviewed paper made that claim until it was retracted.advertisement There’s a way to spot data fakery. All journals should be using it APStockcenter_img The antidote is simple — in theory, at least. Scientists need to focus less on pumping out articles and more on producing replicable and robust results. The journalists who cover them, meanwhile, should spend less energy trying to follow the bouncing ball of what the latest data show and devote more time to finding context for those findings. (Just in case you need evidence journalists aren’t always doing that, we have an, um, study about it.)In a thought experiment designed to generate more informative science news, John Rennie, former editor in chief of Scientific American, once proposed a self-imposed “moratorium that forbade writing about new scientific findings until six months after their journal publication.” Rennie’s proposal, which he floated six years ago, was really just a trial balloon. He (and we) think journalists should write about what they want, when they want. But they should also take time to figure out whether the findings are likely to hold up. Journalists who don’t fact-check deserve criticism, whether the topic is politics, entertainment, or science. But the real trouble with fake news is when there’s a kernel of truth in the pile of garbage. That’s especially problematic in science: scientists continue to dress up weak findings in flashy clothes, all the better to publish with. Then their universities often bolster this flimsy work with frothy press releases that journalists fall for.advertisement Come to think of it, that might work for political coverage, too. Instead of posting a story 20 minutes after Trump’s latest tweet, maybe journalists who cover the administration should hold off on their stories until they’ve verified what the new president and his mouthpieces are really saying. (Before our colleagues shout “Not all reporters!” — we know that good reporters already do this.) True, the pace of news would slow down dramatically, but so would the flow of fake stories.That’s an experiment worth testing. Should science fraudsters have to serve jail time? We could go on. But as you’ve gathered by now, science in its current state isn’t exactly keeping us safe from bogus research. Predatory publishers continue to churn out papers for a price, with minimal peer review — or very often no peer review — to vet the results. Unscrupulous researchers use those and other soft spots in the scientific publishing system to get away with presenting wild theories or cooking their data.last_img read more

Pharmalot, Pharmalittle: Galena CEO abruptly resigns shortly after probe is disclosed

first_img Ed Silverman What’s included? @Pharmalot Pharmalot, Pharmalittle: Galena CEO abruptly resigns shortly after probe is disclosed Log In | Learn More By Ed Silverman Feb. 2, 2017 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints What is it? Alex Hogan/STATcenter_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. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] GET STARTED Pharmalot 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. Rise and shine, everyone, and how are you today? Puffy gray clouds are hovering over the Pharmalot campus, where the official mascots are happily snoozing and the shortest of short people has left for the local schoolhouse. As for us, we are considering our to-do list and brewing a needed cup of stimulation, since we anticipate another busy day. No doubt, you can relate. So time to get cracking. Here are some items of interest to get you started. Have a wonderful day and drop us a line when something interesting arises …Galena Biopharma chief executive Mark Schwartz abruptly stepped down as chief executive and president — and resigned his seat on the board — on Tuesday, although no reason was given. The move, however, comes shortly after the biotech disclosed a criminal investigation by the US attorney’s office in New Jersey and the US Department of Justice into marketing of its Abstral painkiller. Schwartz had headed the company since 2014. Tags opioidspharmaceuticalsSTAT+last_img read more

Against a history of medical mistreatment, African-Americans are distrustful of hospice care

first_imgCorrection: an earlier version of this article incorrectly referred to Dr. Alvin L. Reaves’ affiliation with Emory University. It is his past employer, not his current one. By Bob Tedeschi April 5, 2017 Reprints Young women with breast cancer learn to celebrate life — and say goodbye Patrick Dillon, a Kent State University communications professor who has researched this topic, said some who opted for hospice care faced accusations of rejecting the “we-take-care-of-our-own” ethos that is common in many African-American families.“It’s caused fractured relationships with friends, family, people in the church,” he said. “There’s a social risk associated with this decision.”Dillon said that physicians who would approach African-Americans about the benefits of hospice care would do well to understand that there are often many more people affecting the decision than are visibly present.Focusing on the idea that hospice is a valuable tool for taking care of a family member — and not an abandonment — may help. It would be even better if the message were echoed by a local clergy member or another trusted member of the community who is not a physician.There’s a growing appetite for ideas like these among black doctors who serve those at life’s end. At a national meeting of palliative care and hospice clinicians in February, Dr. Alvin L. Reaves, of Regional Medical Center in Orangeburg, S.C., organized the first meeting of a group of black professionals, patients, and families in the palliative care community. “So afterwards I asked her, ‘What the hell did I do?’ And she said, ‘Ivan, you were not talking to them. You were talking to your academic staff. You have to come down to the people.’”Turns out, it was much more than just that.Medical researchers who are working to unpack the issue view minority access to hospice care as a matter of social justice. It’s typically paid for by the government, can reduce patient suffering, and relieve family members of the burdens of caring for a dying loved one.Why should African-Americans continue to suffer more at life’s end than others?There’s a lot to sift through, starting with the medical industry’s long and at times ugly history of neglect and abuse of blacks.Doctors can also fail to account for the pervasive belief among many African-American faithful that God has an ability to heal the sick through miracles.Finally, there’s the reality that some in tighter-knit African-American communities can direct harsh judgments toward those who choose hospice. Some see hospice as an abdication of caretaking responsibilities, at best, or, at worst, a hastening of a loved one’s death. (Research actually shows hospice patients live longer than those who opt for more aggressive end-of-life treatments.) At a hospice facility for children, a long goodbye is made a little less lonely EndnotesAgainst a history of medical mistreatment, African-Americans are distrustful of hospice care Related: Armella Leung for STAT Related: Reimagining hospice care — for the living “All of them looked at me with a cold face,” he said. “And then this volunteer takes over for me, stands up, and says, ‘God is good!’ And everybody’s like ‘A-MEN!’” The medical community has long known that African-Americans resist hospice care at far higher rates than other groups. But Dr. Ivan Zama, a hospice and palliative care physician, felt like he could still change some minds when, in 2010, he was asked to address a group of African-Americans at an assisted-living facility in Maryland.Zama, who is black and was born in Cameroon, prepared his most persuasive slides. He enjoyed a warm introduction from a facility volunteer. Then he made his case.Crickets.advertisement Related: Roughly 40 others attended, trading tips about what worked, and what didn’t, in their respective practices.Many things don’t work, Zama said after the meeting.Zama took away some ideas, he said, and offered some of his own.He has, at times, relied on his Catholic background to convince patients and family members that hospice does not run counter to Christian tenets, pointing out that Pope John Paul II chose to die at home without life-extending measures. (Greg Schleppenbach, a spokesman for the United States Conference of Catholic Bishops, called hospice “laudable and beautiful.”)That approach is in keeping with a method that Zama said he developed not long after his hospice presentation debacle. In his second presentation — this time to a different group — he ditched the PowerPoint.“I walked in there and I said, ‘You know, God says that we all have a mission.”He paused, and hoped.“A-MEN!” Zama, who is amiable and fit, with a thick accent, laughs now at the memory.advertisement Tags end of lifelast_img read more

What hackers? Most pharma execs feel secure about their data

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Despite a never-ending spate of hacking incidents, a majority of drug makers report they feel “more secure” about their computer security, according to a newly released survey.Specifically, 62 percent of pharmaceutical and biotech companies expressed confidence in their security arrangements, and just 14 percent acknowledged they felt less secure, according to the poll conducted last February and March by KPMG, the financial advisory firm. What is it? DAMIEN MEYER/AFP/Getty Images What hackers? Most pharma execs feel secure about their data 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. About the Author Reprints Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Ed Silvermancenter_img @Pharmalot GET STARTED [email protected] Pharmalot By Ed Silverman July 24, 2017 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? Tags pharmaceuticalsSTAT+last_img read more

4 steps to reversing the epidemic of opioid use disorders

first_img About the Authors Reprints By Brian D. Sites and Matthew A. Davis Aug. 1, 2017 Reprints Brian D. Sites Tags addictionopioidspain Second, we need to develop and put in place health policies and practice guidelines — totally free of influence by the drug industry — that aim to reduce physicians’ dependency on opioids for treating pain. This may involve building infrastructure to routinely offer alternative therapies such as cognitive behavioral therapy, acupuncture, physical therapy, and access to mental health experts.Third, we need to carefully vet policies regarding financial reimbursement for outcomes such as patient satisfaction to anticipate any indirect effects on opioid prescribing.Finally, we need to quickly put in place regulatory policies to identify fraudulent prescribing practices and improve access to drug addiction treatment.Pain rarely kills, though we know of people in chronic pain who feel like it is killing them. But pain pills are actually killing astonishing numbers of vulnerable Americans. If we don’t resolve this opioid problem, thousands more will needlessly die.Brian D. Sites, M.D., is an anesthesiologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Matthew A. Davis, Ph.D., is an assistant professor at the University of Michigan School of Nursing and the Institute for Healthcare Policy and Innovation. First Opinion4 steps to reversing the epidemic of opioid use disorders Paraphernalia for injecting drugs in Huntington, W.Va. Brendan Smialowski/AFP/Getty Images Several historic events led us to this juncture. In the 1990s, multiple professional societies argued that physicians weren’t doing enough to treat people in pain and needed to improve pain management. This advocacy was based on the notion that the current levels of disability related to pain was unacceptable. Based on the educational efforts of major US health systems and leading professional societies, pain came to be thought of, and treated like, a vital sign. In 2001, hospitals were prompted to create pain management standards, including the process of recording patients’ perceptions of their pain in a way that made it easier to assess and treat pain. The results of this social advocacy and regulatory behavior led to a skyrocketing number of prescriptions for opioids. But troubling data emerged from the Centers for Disease Control and Prevention: Despite this increase, there was little to no improvement in Americans’ pain.advertisement Related: STAT forecast: Opioids could kill nearly 500,000 Americans in the next decade Related: Matthew A. Davis This poor correlation between increasing opioid prescribing and health benefits is sadly and starkly contrasted with the tight correlation between increasing opioid prescribing and rising health care expenditures, opioid abuse, overdose, addiction, diversion, and death.While the early advocates for the liberal prescription of opioids are no longer vocal, there continue to be insidious incentives to prescribe opioids. For instance, physician reimbursement is now closely linked to patient satisfaction surveys. There is deep concern in the medical community that overprescribing may be occurring as a function of the desire to optimize patient satisfaction.How do we start to make things better?First, we need to identify individuals who are at high risk for opioid use. Our new research on opioid prescribing found that Americans with mental health disorders such as depression and anxiety, a group that represent 16 percent of U.S. adults, receive more than half of all opioid medications distributed in the U.S. The high use of opioids among this population is particularly concerning because mental illness is also a prominent risk factor for overdose, abuse, and long-term use. [email protected] Health care professionals share a common and lofty goal: to minimize their patients’ pain. But what if we’re hurting more people than we’re helping? That may be the sad reality of the opioid epidemic, one driven in part by doctors’ desire to do good.The use and abuse of prescription opioids like hydrocodone and oxycodone is currently among the most significant health crises today. While Americans account for only 5 percent of the world’s population, we consume approximately 80 percent of the world’s prescription opioids. Overdoses from prescription opioids are the major driver of the 15-year increase in opioid overdose deaths. Overall, prescription opioids are now killing more people each year — 22,000 by last count in 2015 — than die from homicide.Why is the problem of prescription opioids unique to the United States?advertisement A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fear last_img read more