What to look for when buying probiotics

first_imgHealthWhat to look for when buying probiotics Probiotic supplements abound in health food stores these days. The science doesn’t back up many of the bold health claims, though, and there’s minimal federal oversight or quality control of the products, which contain live bacteria meant to supplement or alter the microbial community already present in your gut.Read more: Probiotics make bold health claims, but the science is shakyDoctors say there’s no proven medical reason for most people to take probiotic supplements. But they’re unlikely to cause any harm. If you do want to give them a try, here are some tips to make sure you’re getting what you expect:The bacteria should be present in adequate amounts, which means billions of CFUs, or colony-forming units. The human gut contains trillions of resident bacteria, so scientists estimate at least one billion probiotic organisms are needed to make an impact via the intestine. Tags dietary supplementsnutritionprobiotics The bacteria should confer a health benefit, backed up by human trials that showed the probiotics had a positive effect on a specific condition. A group of experts recently compiled the clinical evidence for 40 brand-name probiotic products in Canada, many of which are also sold in the United States. Check out their ratings for each product, Levels I-III, based on the strength of evidence for specific health conditions. Be wary of products sitting on a shelf or in high temperatures for long periods of time. If bacteria experience any moisture or heat, they’ll begin to grow, use up the resources around them, and die. “If you pick a product in a shop window in Texas in the middle of summer, good luck,” said Gregor Reid, director of the Canadian Research and Development Centre for Probiotics at the Lawson Health Research Institute. Megan Scudellari A variety of probiotic drinks, powders, and chocolates available at health food stores. Alissa Ambrose/STATcenter_img Keep in mind that certain individuals should not take probiotics. Those with bowel damage due to injury, surgery, chemotherapy, or severe infection should steer clear due to the risk that the bacteria could migrate out of the intestines and into the bloodstream, said Dr. Shira Doron, a physician and epidemiologist at Tufts Medical Center. Individuals with compromised immune systems should also be wary, she added, since the immune system is needed to keep gut bacteria in check. [email protected] The bacteria should be living. If they are dead or inactivated, they’re not probiotics. By Megan Scudellari Jan. 21, 2016 Reprints About the Author Reprintslast_img read more

Strict rest may not be best medicine for kids’ concussions

first_img CHICAGO — Strict rest may not be the best medicine for kids with concussions, a Canadian study found, challenging the idea that physical activity should be avoided until symptoms disappear.A month after their concussions, ongoing or worse symptoms were more common in children and teens who were inactive during the week following injury, compared with those who engaged in physical activity during that first week. Activity was mostly light exercise including walking and swimming.The results were similar even among those who early on had three or more concussion symptoms, which can include nausea, headaches, and confusion. Physical activity still seemed to reduce chances for lingering symptoms a month after the concussion.advertisement Patients in the study and their parents were asked about symptoms and physical activity at seven and 28 days after the concussionIn the early-activity group, 29 percent reported ongoing or worsening symptoms 28 days after concussions versus 40 percent of the group reporting no extra physical activity beyond daily living activities.Among kids who reported having three or more symptoms in that first week, those who engaged in early physical activity regardless of intensity were 25 percent less likely to have ongoing or worse symptoms at 28 days than the no-activity group.Zemek said more research is needed to determine the ideal timing and intensity of physical activity to recommend after a concussion “to provide the best balance between symptom resolution and safety.”Until there are clear answers, the editorial says doctors and parents “should use common sense about allowing limited physical activity as tolerated and be cautious about resting a previously active athlete for prolonged periods.”— Lindsey Tanner Nearly 2 million concussions each year in kids’ sports, play Carlos Osorio/AP In the LabStrict rest may not be best medicine for kids’ concussions Related: Related: The researchers surveyed about 2,400 kids aged 5 to 18 treated for concussions in nine emergency departments in Canada. Most were sports-related injuries and most kids had at least one concussion symptom in the first week.Results from the 2013-2015 study were published Tuesday in the Journal of the American Medical Association .Current guidelines recommend rest until symptoms disappear to avoid additional concussions, which can increase chances for permanent brain damage. But an editorial published with the study says that advice “has resulted in some athletes resting for weeks or months, at which point rest may be less helpful and perhaps even harmful.”The study authors say resuming physical activity may increase blood flow to the brain, while inactivity may deprive patients of not only that benefit but also the psychological benefits of activities they enjoy. “It’s still important to have caution in the immediate post-injury period,” said lead author Dr. Roger Zemek, an emergency medicine specialist at Children’s Hospital of Eastern Ontario. After a sports-related concussion, kids “should always be removed from play and not return that day.” By Associated Press Dec. 20, 2016 Reprints Why rest helps the brain recover from concussion Tags concussionsresearch To avoid re-injury, kids should generally be sidelined from the sport or activity that led to the concussion until a doctor clears them to return, he said. But the study results suggest they can resume sports or other physical activities sooner than previously thought, he said.advertisement Associated Press About the Author Reprintslast_img read more

He vowed to cure cancer. But this billionaire’s moonshot is falling far short of the hype

first_img Precision medicine, linked to DNA, still too often misses He debuted the tool at a big scientific meeting for cancer specialists last summer. In an unusual move for a CEO, Soon-Shiong sat at the Nant booth in the sprawling exhibition hall, explaining the company’s products and taking questions from physicians — a role usually left to sales representatives.Soon-Shiong’s team claims that GPS Cancer is the most comprehensive test of its kind. The primary thing that seems to set it apart from the competition is that it reports on the precise amount of different proteins expressed by genes that may be important in the biology of a tumor — and then advises oncologists about which drugs may work best.But physicians have not quickly warmed to the test. Only 524 tests were ordered in the third quarter of last year. As of August, there were just six insurers covering the test — two of which were moonshot collaborators, Bank of America and Independence Blue Cross. (A few more insurers in the US and abroad have since followed.)It’s expensive, at an average of $11,500 per test, according to a financial analyst’s note from last summer.Asked for published studies validating GPS Cancer, Hodson provided two that suggested analyzing protein expression can give important clues as to which cancer therapies are likely to be most effective. Financial analysts expect studies measuring the test’s efficacy to come in the first half of this year. Please enter a valid email address. Related: Though Soon-Shiong has talked for a year about bringing major drug companies into the coalition, so far, just two have joined: Amgen and Celgene. He is a shareholder in both. And both are investors in Soon-Shiong’s companies.Both companies confirmed they are not involved in the moonshot’s clinical trial program but provided no additional information about their participation. Tags biotechnologycancerdiagnosticspharmaceuticalsresearchWhite House Related: How the world’s richest doctor gave away millions — then steered the cash back to his company Related: Related: The moonshot focuses on the hot field of immunotherapy, which involves revving a patient’s immune system into high gear to fight cancer. Soon-Shiong, like others in the field, plans to focus on testing drugs in various combinations. But he’s bent on doing it faster than everyone else. His plans center on two types of immunotherapies: a treatment vaccine and genetically engineered “natural killer” cell therapies being developed by one of his businesses.STAT found that the moonshot has aggressively promoted an expensive diagnostic tool, called GPS Cancer, which analyzes patients’ tumors and recommends a course of treatment. It’s sold by one of Soon-Shiong’s companies and drives business to labs owned by another of his companies.Under the banner of the moonshot, Soon-Shiong has paid for researchers around the world to use GPS Cancer in their work, even though there have been as yet no published studies validating it as an effective diagnostic test. Indeed, several of the “milestones” the moonshot initiative has cited as exciting progress in the war on cancer simply involve various doctors or hospitals agreeing to use GPS Cancer. “Sometimes some people do things, and it creates exponential change in mankind.” NantHealth needs GPS Cancer to do well. The company made its public debut in June, but its stock price has slipped 53 percent since then. And it’s bleeding money; the company had lost $324 million as of the first quarter of last year; it tacked onto a net loss of $54 million in the second quarter of last year, and $37 million more in the third quarter of last year.“Ultimately the stock trades off of getting additional payers announced in terms of reimbursing for the test,” said Richard Close, a financial analyst who follows NantHealth for Canaccord Genuity. Although he hasn’t seen the moonshot affect the company’s fortunes so far, it can only help in boosting the adoption and coverage of GPS Cancer that will be key to the company’s future growth, he said.For now, the moonshot project is helping Soon-Shiong get the word about GPS Cancer out far and wide and establish it as a cutting-edge tool — even before those validation studies are in.Last fall, in what was billed as a moonshot initiative “milestone,” Soon-Shiong’s research institute awarded a $20 million grant to several hospitals to use GPS Cancer to sequence brain tumors in 1,600 children. The hospitals, including Children’s Hospital of Philadelphia, announced earlier this month that some of the grant money would pay for the use of GPS Cancer in patients whose insurance didn’t cover it.The press release quoted Soon-Shiong as calling GPS Cancer “an incredibly comprehensive test that provides oncologists with the peace of mind that they are making the most informed decisions before developing a treatment plan.” By Rebecca Robbins Feb. 14, 2017 Reprints Related: The supremely self-confident billionaire behind that vision has drawn attention at the highest levels: He’s talked cancer research with Joe Biden, Bill Clinton, even the Pope. He’s met with President Donald Trump at least twice since the election. Riding high on his pledge to win the war on cancer, Soon-Shiong is said to have pitched a role for himself as national health care czar in discussions with Trump’s team.But a STAT investigation of Soon-Shiong’s cancer moonshot has found very little scientific progress. At its core, the initiative appears to be an elaborate marketing tool for Soon-Shiong — a way to promote his pricey new cancer diagnostic tool at a time when he badly needs a business success, as his publicly-traded companies are losing tens of millions per quarter. STAT also found several instances of inflated claims, with the moonshot team taking credit for progress that doesn’t appear to be real.Soon-Shiong’s use of the moonshot to advance his business interests may be good for his investors. But it also increasingly looks destined to disappoint patients — the latest in a long trail of failed quests to win the war on cancer.advertisement NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. Among STAT’s most striking findings were cases of Soon-Shiong’s team taking credit for progress that doesn’t appear to have been made.Soon-Shiong’s statements, for instance, said that global pharma companies Pfizer and Merck KGaA had joined the moonshot — which, if true, would be a big step in building a worldwide coalition. But spokespeople for those companies said they’re not aware of any involvement. The moonshot’s website also lists Johns Hopkins as a collaborator; neither the university or its affiliated hospital was aware of any such involvement.Other companies and institutions are characterized as moonshot collaborators mostly, it appears, because they have committed to using or paying for doctors to use GPS Cancer.In another example of inflated claims, Soon-Shiong cited launching “over 20” clinical trials as an example of the “remarkable progress” made in the first year of the moonshot. He pointed STAT to a federal registry listing 23 trials. But 13 of them were launched years before the moonshot even started — in some cases, almost a decade before. Ten of them were completed before the moonshot was launched.Asked why he was counting these old trials as current accomplishments, Soon-Shiong said he and his team have selected experimental therapies from old trials as “worthy candidates” to be tested in new combinations. Privacy Policy The moonshot website also touts a “historic alliance” with companies like Bank of America, which insures its own employees, and Independence Blue Cross, a Blue Cross and Blue Shield affiliate based in Philadelphia. The role of both appears to be simply that they cover doctors’ use of the GPS Cancer diagnostic for patients on their insurance plans. (Other corporate partners, BlackBerry and Allscripts, have invested in Soon-Shiong’s NantHealth.)From the start, the GPS Cancer test has been a central element of the moonshot. Press releases call it a “key enabler” and a “cornerstone” of the whole initiative.And a promotional video for the moonshot project doubles as an advertisement for GPS Cancer. The video cites the diagnostic test by name and trumpets it as crucial element of a plan to “win the war on cancer by the year 2020.”Soon-Shiong has high hopes for GPS Cancer, which involves two of his businesses: NantHealth sells the diagnostic tool and NantOmics labs interpret the results. “The clinical breakthroughs touted by Patrick Soon-Shiong are less than modest — they are the most miniscule and vague findings.” Those conclusions are based on a review of hours of video and dozens of scientific presentations, legal filings, clinical trial summaries, and press releases, as well as exchanges with more than a dozen physicians and institutions named as  moonshot collaborators. Special ReportHe vowed to cure cancer. But this billionaire’s moonshot is falling far short of the hype Soon-Shiong himself declined repeated requests for interviews in recent months, though spokeswoman Jen Hodson did provide two lengthy statements she said to attribute to him. They touted nine areas of “remarkable progress” achieved in the moonshot initiative’s first year.STAT asked several independent scientists to review Soon-Shiong’s claims. Their conclusion: The data don’t back up the hype.“The clinical breakthroughs touted by Patrick Soon-Shiong are less than modest — they are the most miniscule and vague findings,” said Dr. Vinay Prasad, a hematologist-oncologist at Oregon Health and Science University. He called them “overblown beyond what is reasonable or fair.” At its core, the moonshot appears to be an elaborate marketing tool to promote Soon-Shiong’s pricey new cancer diagnostic tool at a time when he badly needs a business success. Dr. Patrick Soon-Shiong The world’s richest doctor had a very bold plan.He’d assemble an unprecedented collaboration of companies, researchers, and doctors. Their mission: to vanquish cancer. By the year 2020, they’d build a working vaccine and test therapies in 20,000 patients. They would forever transform medicine.Or so Dr. Patrick Soon-Shiong vowed when he launched his audacious “Cancer MoonShot 2020” a year ago.advertisement Biotech billionaire in talks with Trump about a senior health care role, sources say Soon-Shiong touted “clinical breakthroughs,” but as proof, pointed to a lone research poster, documenting that tumors shrank in one patient after experimental therapy. Drug companies have poured years, and many tens of millions, into immunotherapy; while they still think it has significant promise, they point to an array of serious challenges, including patient deaths in clinical trials, harsh side effects, relapses, and the grim reality that the treatments only work for a small percentage of patients.And some of Soon-Shiong’s ideas about the field are “far-fetched,” said Dr. Eric Topol, a geneticist who directs the Scripps Translational Science Institute. Consider Soon-Shiong’s oft-stated conviction that the engineered natural killer cell therapies he’s developing through his company NantKwest could be a universal treatment, effective for any patient. There’s no evidence to back up that claim.“Some of his ideas may ultimately click someday, but he talks about them as if there’s more support than there is. And if there is more, it sure isn’t published,” Topol said. Trump in 30 seconds: Science and medicine in flux Archive – Feb. 1 – Mar. 20, 2017 Soon-Shiong has also spoken extensively about promoting collaboration between big players in the world of cancer research. But so far, STAT has found, it appears that all of the corporate collaboration involves research conducted by a handful of early-stage biotech companies — all of which Soon-Shiong owns or holds stakes in.Some academics have credited the moonshot with advancing their work, in part by launching  “working groups” focused on specific types of cancer. Among the topics discussed by at least some of the working groups: How to use Soon-Shiong’s GPS Cancer tool in clinical trials.Daring visionary — or shameless self-promoter?Soon-Shiong, 64, has long had a reputation as a daring visionary — or a “shameless self-promoter,” depending on who’s describing him.He launched his moonshot the very same week that then-Vice President Biden introduced the federal moonshot to fight cancer. (The two are completely separate, though Biden did ask Soon-Shiong to advise him on the federal project.)In the year since, Soon-Shiong’s enormous ambition for his own initiative has only inflated. What was originally called “the nation’s” most comprehensive collaboration against cancer is now billed as “the world’s” most comprehensive. On social media, Soon-Shiong’s team boasts that it’s planning to develop not just an effective vaccine, but one that could treat “all cancer types at every stage” — within about three years.His team has also inflated the initiative’s name: It’s now called Cancer Breakthroughs 2020, because calling it a moonshot “hardly does us justice,” the website explains. Dr. Vinay Prasad, oncologist Related: Meet Trump’s would-be health czar: A billionaire with a brash vision, a bodyguard — and a divisive record As for the pledge to treat 20,000 patients in the next few years, the moonshot appears to be far off the pace needed to reach that goal.STAT looked at all the studies affiliated with the moonshot’s primary clinical trial program, known as QUILT, since the initiative launched. There are slots for just 252 patients, and not all have been filled. (There may be other studies that are not part of QUILT or are too early-stage to be listed on the federal registry of clinical trials, but Soon-Shiong’s team did not provide any such information.)The moonshot is breaking new ground this month with the first human test in the US of an experimental cancer treatment that combines a “fusion protein” with natural killer cells.Outside scientists say it is an intriguing concept. But this is just a trial to test safety, most likely in a patient with Merkel cell carcinoma. Even in a best case scenario, it is many years removed from being widely used.On the conference circuit to promote the moonshot, Soon-Shiong stopped by a meeting chaired by Topol last March. He outlined a vision, Topol said, that “everyone who was there thought… was very ambitious — and unattainable.”Dr. Patrick Soon-Shiong arrives in the lobby of Trump Tower in New York last month for a meeting with President-elect Donald Trump. Evan Vucci/APThe moonshot as a marketing toolWhen you look closely, Soon-Shiong’s moonshot initiative looks less like a diverse coalition than a roll call of his tangled web of business interests.For starters, it’s not a separate legal entity; it appears to be housed within Soon-Shiong’s cluster of companies.The five biotech companies that are participating in the moonshot are the only ones sponsoring registered QUILT trials. And they are all closely tied to Soon-Shiong: He is either the CEO, a board member, or the controlling owner in each of them. Genetic testing fumbles, revealing ‘dark side’ of precision medicine Dr. Peter Fasching, moonshot collaborator Related: “It’s moving faster than anything I’ve been part of yet.” Alex Hogan/STAT Who’s the billionaire doctor palling around with Donald Trump? In his statements to STAT, Soon-Shiong boasted that his initiative has achieved “clinical breakthroughs” in its first year.As evidence, though, he pointed to just one research poster, not yet peer reviewed: It found that tumors had shrunk in one of three patients treated with an experimental therapy involving NantKwest’s natural killer cells for a rare cancer called Merkel cell carcinoma.“This is the type of poster that you pass quickly on your way to credible data in an oncology conference,” said Prasad, the Oregon oncologist.The moonshot website does reference one other research poster, touted as a “milestone.” It looked at 47 patients with advanced colorectal cancer who received an experimental drug. The group fared better than similar patients observed in the past. But the trial was lacking a key control: It did not directly compare the new treatment to any alternative. And it only followed patients for about two years, not the five-year window considered the gold standard for cancer research.Soon-Shiong also told STAT he had achieved pre-clinical “scientific breakthroughs.” He pointed to research, presented at a scientific conference, that found a combination of a targeted therapy and natural killer cells showed promise in attacking cancer cells in the lab.STAT was only able to find one published study associated with the moonshot initiative. Heralded as a “milestone,” it found that a protein complex designed to stimulate immune cells fought tumors in mice and boosted immune activity in monkeys. That therapy is now moving on for safety testing in humans. Over the past year, Soon-Shiong’s team has also set up at least a half a dozen working groups to take on different types of cancer. (The group focused on head and neck cancers, incidentally, is co-chaired by Biden’s son-in-law Dr. Howard Krein.)Several of the participating scientists told STAT they hadn’t done much yet as part of those working groups. But others were optimistic about their progress.The experience of the German researcher Dr. Peter Fasching offers a window into how the moonshot is spurring academic research — even while it advances Soon-Shiong’s business.Fasching, a women’s health specialist, is involved in the working groups for breast cancer and for inflammatory breast cancer, an aggressive and deadly form of the disease. Their in-person and virtual meetings so far, he said, have centered on discussing their experiences with GPS Cancer and planning clinical trials.Fasching is the lead investigator for an early-stage moonshot QUILT trial that will test one of the natural killer cell compounds developed by Soon-Shiong’s NantKwest company. He is also collaborating with Soon-Shiong to test GPS Cancer in another clinical trial, sponsored by a German research network.Fasching said he thinks it’s too early to evaluate the success of the moonshot project, but he likes GPS Cancer and said he’s pleased with how things are going. Among clinical development programs, he said, “it’s moving faster than anything I’ve been part of yet.”There’s every indication that Soon-Shiong, for his part, is as confident as ever in the vision he expressed in the press conference a year ago announcing the moonshot: “Sometimes some people do things,” he mused, “and it creates exponential change in mankind.”He’s borrowing the name of one such transformative figure when he unveils his next big thing next week at a health technology conference. A press release describes it, in typically breathless Soon-Shiong fashion, as “the world’s first whole genomics transcriptomics supercomputing medical reasoning engine” and boasts that it’s “covered by over 100 seminal patents.” Its name: the NantDaVinci Engine. Leave this field empty if you’re human: The change might also have something to do with a lawsuit filed by the University of Texas’s MD Anderson Cancer Center, which has long had a trademark on the moonshot name and has used the term for marketing and fundraising. (Biden’s team paid to license the name from MD Anderson, according to the suit.)The trademark infringement suit, which the cancer center continues to pursue, attacks Soon-Shiong in surprisingly personal terms. It claims that he has sullied the entire concept of a moonshot with his “nakedly self-enriching” behavior and his reputation as “a greedy, if not shady, billionaire businessman who oversells his ideas and falsely takes credit for other’s work.”Soon-Shiong called the lawsuit “disappointing” and an example of big-name institutions resisting innovation. “Patient care and actions matter more to us,” he said in comments provided by his spokeswoman, “than arguing over who has the right to use the word moonshot!”An excerpt from a lawsuit against Soon-Shiong filed on behalf of the MD Anderson Cancer Center. STATResearchers who have worked closely with him say the former transplant surgeon, whose net worth is estimated at $8.8 billion, genuinely cares about patients and is passionate about pushing science forward.Dr. Azra Raza, who studies early stage leukemia, wrote Soon-Shiong a letter out of the blue to plead for research funding a few years ago, after seeing him on the TV news show 60 Minutes. A few months later, he cold-called her — and ended up endowing her faculty chair at Columbia University. Later, as part of the moonshot, he let her sequence 157 bone marrow tissue samples for free through one of his companies. She calls her experience with the moonshot so far “extremely positive.”Other scientists, however, are deeply skeptical of Soon-Shiong. In the early 1990s, he seemed to be suggesting he had cured diabetes after he implanted cells that secrete insulin in a patient. But the results didn’t hold up.Bold claims of breakthroughs, with little evidenceIt’s hard to overstate what a presumptuous goal it is to aspire to develop a cancer vaccine that could treat any patient by 2020.To be sure, Soon-Shiong’s general idea for a vaccine — to customize it for each patient based on the unique genetic markers of their tumor — is widely seen as a promising approach within the field of immunotherapy.But the reality is that the science is incredibly hard. There are just one or two — depending on your definition — approved cancer treatment vaccines on the market. They’re meant for narrow subsets of patients and have shown mixed results.last_img read more

NIH budget cuts will jeopardize America’s leadership in medical research

first_img GET STARTED NIH budget cuts will jeopardize America’s leadership in medical research About the Author Reprints By Ronald A. DePinho April 7, 2017 Reprints In the last 10 years, remarkable advances have been made in how we fight cancer, work that was made possible by our nation’s support of biomedical research, largely through the National Institutes of Health. One of the most powerful new tools in our arsenal is cancer immunotherapy, which reawakens the body’s own immune system. Immunotherapy drugs have produced stunning results for many people suffering from advanced cancer.Immunotherapy saved President Jimmy Carter’s life. After being diagnosed with advanced melanoma that had spread to his brain, he underwent a combination of immunotherapy and radiation treatment. What could have been a sad story of death within months has turned into a compelling story of survival with no signs of cancer. Lydia Polimeni/NIH What’s included? Politics Tags cancerpolicyresearchcenter_img What is it? 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. Ronald A. DePinho @RonDePinho Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED Log In | Learn More 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

Antibiotics could dramatically reduce STIs, study says, raising tough new questions

first_imgHealthAntibiotics could dramatically reduce STIs, study says, raising tough new questions Privacy Policy The organism treponema pallidum, which causes syphilis. AP Leave this field empty if you’re human: Rates of syphilis in particular have risen steadily in recent years; the rate in 2015-2016 — 8.7 cases per 100,000 people — was the highest since 1993, the Centers for Disease Control and Prevention reported. The rate of infection increased in every age group over the age of 15, in both men and women, and in all ethnic groups.Molina’s study was recently published by the journal Lancet Infectious Diseases. The Bill and Melinda Gates Foundation was one of its funders.The researchers randomly assigned 232 men to one of two groups. One of the groups was given antibiotics — the drug doxycycline — to take if they had unprotected sex. They were told to take two pills per encounter, and no more than six in a week, ideally within 24 hours and no later than 72 hours after the intercourse. In reality, the median use among the men was about 6.8 pills per month.The men were tested regularly for STIs, and in the nine or so months they were followed, the rates of some sexually transmitted infections fell dramatically in the treatment group. The overall reduction of all STIs was 47 percent, but that average was dragged down by the fact that doxycycline doesn’t cure gonorrhea.There was, however, a 70 percent reduction in chlamydia infections and cases of syphilis decreased by 73 percent. The authors noted, however, that the study length was short and they can’t tell if the strategy would work as well over the long term.The results can’t be taken in isolation, others experts warned. Using doxycycline this way could drive the bacteria that cause the infections to develop resistance to the drug, warned Dr. Brad Spellberg, an infectious diseases specialist and chief medical officer at the Los Angeles County-University of Southern California Medical Center in Los Angeles.Spellberg also said people who used the drug this way would be exposing the bacteria they have in their gastro-intestinal tracts — their own gut flora — to regular doses of doxycycline. And those bacteria too could develop resistance to the drug, leading to a host of other health problems.“You’re causing friendly fire injury,” he said.The full picture of the knock-on effects of exposing your gut flora to antibiotics is still coming into focus, said Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics, and Policy and a leading voice on the dangers of mounting antibiotic resistance. He noted a recent report in the journal Science revealed that some cancer immunotherapy drugs worked less well in people who had recently taken antibiotics. Exclusive analysis of biopharma, health policy, and the life sciences. Molina noted that antibiotic resistance to doxycycline has not been seen in chlamydia or syphilis, despite the fact that the drug has been used to treat these infections for decades. Still, he said the possibility it could arise cannot be discounted.A commentary published with the study argued that reducing infection rates in men who have sex with men and who are highly sexually active might lower STI infection rates more generally in a community.Authors Christopher Fairley and Eric Chow, of Australia’s Melbourne Sexual Health Center at Monash University, said pressure from patients to be given doxycycline on a preventative basis might be substantial, given that the drug is also prescribed in six-month courses to treat acne. Like Molina and his co-authors, they said STI preventive use at this point is premature.Laxminarayan did not dismiss the notion of this type of use out of hand, however. “I certainly think that for a small subset of the population, if this helps prevent syphilis, then it certainly is worth exploring further,” he said.But he said additional studies should be conducted first to try to get a better picture of the potential consequences of using doxycycline this way, including the risk of resistance developing, the potential that it might further erode condom use, and any other unintended consequences. Helen Branswell STAT+: Please enter a valid email address. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Molina insisted he would never support long-term use of antibiotics to prevent STIs, but said that the approach might be an effective short-term strategy when paired with other control approaches, like more frequent STI testing among high-risk populations.“I don’t want this strategy to be used widely in any person, clearly,” Molina said. “But if you can select a group with a high incidence rate of syphilis or chlamydia, and you want to try to reduce the rate of syphilis quite quickly in this group of people, you may think that this strategy could be used for a couple of months.”advertisement The spread of some sexually transmitted infections could potentially be dramatically reduced by instructing people who have had unprotected sex to take antibiotics within 24 hours after the intercourse, a new study suggests.But such a strategy, which was tested in a population of men who had frequent unprotected sex with a number of male sex partners, could spark a controversy over the use of antibiotics and the general threat of growing antibiotic resistance.“My message with that study would be that we need to do more research to prevent STIs — because that’s a concern. And this strategy … could potentially be used,” said Dr. Jean-Michel Molina, head of infectious diseases at Saint-Louis Hospital in Paris and the lead author of the study.advertisement Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. By Helen Branswell Dec. 18, 2017 Reprints Tags antibioticssexual health @HelenBranswell About the Author Reprintslast_img read more

Welcome to the first edition of the STAT Health Tech newsletter

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. What is it? STAT Health Tech is our new weekly guide to how tech is transforming health care and the life sciences. Sign up here to receive it in your inbox every Wednesday.Good morning. We’re thrilled to bring you the first edition of STAT Health Tech! Log In | Learn More [email protected] Tags Artificial IntelligenceHealth ITmedical technology @caseymross Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Rebecca Robbins and Casey Ross May 15, 2019 Reprints About the Authors Reprintscenter_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. GET STARTED Health Tech Welcome to the first edition of the STAT Health Tech newsletter 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. Adobe What’s included? Casey Rosslast_img read more

Webinar: Progress and pitfalls in the AI-aided search for novel drugs

first_img By Casey Ross and Kate Sheridan June 20, 2019 Reprints 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. General Assignment Reporter Kate covers biotech startups and the venture capital firms that back them. About the Authors Reprints Health TechWebinar: Progress and pitfalls in the AI-aided search for novel drugs Casey Ross Kate Sheridan @sheridan_kate Artificial intelligence is changing how pharmaceutical companies operate, how they develop and study new treatments, and even what form those treatments take.Pharma companies are now pairing medicines with software — so-called digiceuticals powered by virtual reality and AI. Most of the world’s largest drug companies now have a technology officer in their C-suites. And AI is now being used to help find new drug targets, model diseases, and make clinical trials more efficient. The expanding use of AI poses new scientific and ethical questions about whether the technology is safe and effective, and whether it could be used, wittingly or unwittingly, to subvert regulatory controls and perpetuate bias in the development of new treatments. STAT national technology correspondent Casey Ross and general assignment reporter Kate Sheridan discuss all this and more.advertisement @caseymross Download slides here (PDF). You may view the webinar recording below. Progress and pitfalls in the AI-aided search for novel drugsVolume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2019/06/20/webinar-progress-and-pitfalls-in-the-ai-aided-search-for-novel-drugs/?jwsource=clCopied EmbedCopiedLive00:0041:1841:18  [email protected] [email protected] last_img read more

Pharmalittle: Data show pharma saturated U.S. with opioids; Swiss extradite Chinese researcher

first_img Tags drug pricinggovernment agenciesopioidspharmaceuticalspharmalittleSTAT+ What’s included? Ed Silverman Pharmalot Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED About the Author Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What is it? [email protected] STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.center_img Log In | Learn More @Pharmalot Rise and shine, everyone, the middle of the week is already here. Time moves quickly, yes? Of course, this is good reason to hang in there, since the end of the week cannot be too far away. Besides, what are the alternatives? And do you really want to know? Meanwhile, we are digging in for another busy day of foraging. So time to get cracking. Hope you have a simply smashing day and conquer the world. Meanwhile, here are some tidbits. Good luck. …Drug makers saturated the country with 76 billion opioid pills from 2006 through 2012, the Washington Post writes, citing newly disclosed data from a Drug Enforcement Administration database released as part of the opioid litigation. Just six companies distributed 75% of the pills: McKesson (MCK), Walgreens (WBA), Cardinal Health (CAH), AmerisourceBergen (ABC), CVS (CVS), and Walmart (WMT). Three companies manufactured 88% of the opioids: SpecGx, a unit of Mallinckrodt (MNK); ­Actavis Pharma, which is now part of Teva Pharmaceuticals (TEVA); and Par Pharmaceutical, a subsidiary of Endo Pharmaceuticals (ENDP). Pharmalittle: Data show pharma saturated U.S. with opioids; Swiss extradite Chinese researcher Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman July 17, 2019 Reprints GET STARTED Alex Hogan/STATlast_img read more

Listen: Congressional paralysis, drug shortages, & biotech’s foul mood

first_img @damiangarde Does impeachment have a pharma angle? Who’s to blame for drug shortages? And why is Wall Street down on biotech?We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, STAT Washington correspondent Nicholas Florko joins us to break down what the impeachment inquiry means for the congressional fight over drug prices and the fate of the FDA. Then, Dr. Ben Davies, a University of Pittsburgh urologist, calls in to discuss what happens when key drugs face dangerous shortages. Later, we dig into biotech’s rough third quarter and discuss how things might change before the year’s out. Finally, Davies sticks around for a lightning round, covering rosé, menswear, and mail-order erectile dysfunction pills.For more on what we talk about, here’s the latest on drug pricing legislation; here’s the news on the possible next FDA commissioner; here’s more on drug shortages; and here’s a preview of the coming quarter in biotech.advertisement Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. Adam Feuerstein About the Authors Reprints We’ll be back next Thursday evening — and every Thursday evening — so be sure to sign up on iTunes, Stitcher, Google Play, or wherever you get your podcasts.And if you have any feedback for us — topics to cover, guests to invite, vocal tics to cease — you can email [email protected] [email protected] National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. [email protected] The Readout LOUDListen: Congressional paralysis, drug shortages, & biotech’s foul mood Damian Garde Tags biotechnologydrug pricingpharmaceuticals Interested in sponsoring a future episode of “The Readout LOUD”? Email us at [email protected] By Damian Garde , Rebecca Robbins, and Adam Feuerstein Oct. 3, 2019 Reprints @adamfeuerstein last_img read more

H.R. 3 is the wrong path to lower drug costs

first_imgLeave this field empty if you’re human: The results were eye-opening. In exchange for some short-term price reductions, the bill would drastically damage innovative companies across the country. According to the study, this policy would reduce the Part D revenues for U.S. companies by $358 billion over the next five years, a 58% reduction before interest and taxes. The Congressional Budget Office projects a similar decline — $336 billion over five years for U.S. companies overall.advertisement Privacy Policy From left, Rep. Richard Neal (D-Mass.) speaks as Rep. Frank Pallone (D-N.J.) and House Speaker Nancy Pelosi (D-Calif.) look on during a news conference discussing H.R. 3 on Capitol Hill in October. Zach Gibson/Getty Images Mike Guerra To answer that question, the California Life Sciences Association, which I head, commissioned a study by Vital Transformation, an international health economics firm, to examine the impact of Medicare Part D foreign reference pricing on California as well as the overall nationwide biopharmaceutical ecosystem. Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. Americans want health care to be less expensive. We also want our health care to be the most innovative in the world. The key to simultaneously achieving both of these goals is good public policy.Back in September, House Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) introduced H.R. 3, also known as the Lower Drug Costs Now Act of 2019, into the House of Representatives with 105 co-sponsors, all Democrats. The House is set to vote on the bill this week.H.R. 3 would adopt international reference pricing for the Medicare program in an effort to lower drug costs. In other words, it would impose foreign price controls on the U.S. market. This would indeed reduce prices, but at what cost to innovation?advertisement Please enter a valid email address. Much of the revenue being lost to H.R. 3 through lower drug costs tied to international reference pricing would have been reinvested in new, potentially lifesaving therapies for patients with cancer, heart disease, diabetes, rare diseases, and many other conditions. Small and emerging companies would bear the brunt of this. The 58% reduction in Part D revenue would reduce the number of new medicines that small and emerging companies bring to market by 88% across the U.S., according to our report. What this means is that if H.R. 3 had been in effect from 2009 to 2019, California’s emerging companies would have produced only three drugs instead of the 25 that actually made it to market.H.R. 3 would upend the investment cycle. By making draconian revenue reductions, it would drastically reduce cash flow from operations that would otherwise be used to invest in research and development, licensing, partnerships, and milestone-driven agreements. This is an enormous problem. Companies need at least $500 million, and often more than $1 billion, to take a new drug through clinical trials and ultimately receive Food and Drug Administration approval. In addition, only about 8% of drugs that make it into clinical trials achieve that agency approval. It must also be mentioned that receiving FDA approval does not guarantee that a new drug will be profitable.Emerging biopharma companies depend on investment from larger companies, venture capitalists, and others to have any chance of getting new medicines into and through the approval process and ultimately to the patients who need them. Fewer resources mean investors would take fewer chances. The kinds of high risk/high reward therapies that could help a lot of people would be starved of support.A recent email I received from a cell therapy company CEO provides important context. This CEO wrote that the company will need heavy investment to bring its cell therapy to market. But the price caps being envisioned in H.R. 3 would dramatically limit the return on that investment. As a result, investors would likely look to a less regulated environment, such as tech, and a promising therapy would never get a chance to help patients. Our study shows that emerging biopharma companies like this cell therapy company produce around 70% of the medicines in the U.S. research and development pipeline. Of the 59 new drugs approved nationwide in 2018, 74% originated from small companies.Reducing biopharma earnings by 58% would also sacrifice jobs — 80,000 or more nationwide. These losses could also deplete U.S. stock market valuations by more than $500 billion.Life sciences innovators take these dangers quite seriously. According to the 2019 California Life Sciences Industry Report, biomedical companies in California produced more than $175 billion in revenues, employed more than 300,000 people, and paid nearly $20 billion in federal state and local taxes. These companies are an economic engine that improves health and quality of life for millions of people around the world. And that’s just California. This economic engine is running in many other states as well.Adopting H.R. 3 would be a pyrrhic victory. Yes, it could reduce some drug costs for some people. But in the long run it would also reduce the number of new medicines being produced to help patients, especially those with current unmet medical needs such as Alzheimer’s and rare diseases. In essence, we would be robbing the next generation to help ourselves. That’s not a trade-off we should be making.Mike Guerra is president and CEO of California Life Sciences Association, the statewide trade association for the life sciences sector in California. By Mike Guerra Dec. 9, 2019 Reprints First OpinionH.R. 3 is the wrong path to lower drug costs @CALifeSciences About the Author Reprints Related: Congressional Budget Office says Pelosi drug pricing bill could save $345 billion Tags Congressdrug pricingpharmaceuticalslast_img read more