International panel calls for overhaul of WHO following Ebola crisis

first_imgHealthInternational panel calls for overhaul of WHO following Ebola crisis By Helen Branswell Nov. 22, 2015 Reprints Helen Branswell Ebola burial team members remove the body of Mekie Nagbe, 28, for cremation in Monrovia in October 2014. John Moore/Getty Images Independent Panel on the Global Response to Ebola It said the Geneva-based global health agency should strip itself of unnecessary programs and focus instead on efforts it is uniquely capable of handling. And it called on countries and donors to stop tying WHO funding to specific programs, noting that four of every five dollars the agency receives is earmarked by donors.Read more: 10 ways to protect against a global health disasterIn what seems like a coded indictment of the agency’s Director General, Dr. Margaret Chan, the panel’s report stressed that the WHO must be led by a strong leader unafraid of standing up to the agency’s member states. It also called for the creation of a global health committee within the UN Security Council to bring quick attention to emerging health crises.advertisement Ebola’s deadly tallyVolume 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/2015/11/22/ebola-response-review/?jwsource=clCopied EmbedCopiedLive00:0000:3700:37  The recommendations were drafted by the Independent Panel on the Global Response to Ebola, drawn up of academics, think tank researchers, and leaders of nongovernmental organizations. Their report, published in the journal The Lancet, is one of a number of reviews assessing the Ebola response that have or will soon be released.While the report addressed the roles that should be played by individual governments, the United Nations, and others in the event of a global health crisis, its harshest criticism was leveled at Geneva. “The reputation and credibility of WHO has suffered a particularly fierce blow,” said the panel, which also focused most of its recommendations on reforms there.It added: “Our primary goal is to convince high-level political leaders worldwide to make necessary and enduring changes to better prepare for future outbreaks while memories of the human costs of inaction remain vivid and fresh.”The unprecedented outbreak was more than 10 times larger than all previous known Ebola outbreaks combined. The most recent figures suggest it killed at least 11,314 people and that at least 28,634 people were infected. Early last week it appeared the outbreak might be over. But on Friday Liberia reported three new cases, its first since the summer.Quick action will be critical to reforming the WHO, outside experts watching the process said. Effecting change is difficult and if reform is to flow from the aftermath of the Ebola crisis, the WHO will need to move swiftly to embrace a few key recommendations that can be pushed through, suggested Dr. Jeremy Farrar, director of the Wellcome Trust, a British charity that funds biomedical research.Infectious diseases expert Michael Osterholm concurred. Osterholm, who heads the University of Minnesota’s Center for Infectious Diseases Research and Policy, said the momentum for reform will stall if the various groups critiquing the Ebola response draw up long wish lists. “There can’t be a list of 110 recommendations,” he said flatly.This panel issued 10, though several were made up of multiple parts. A number were aimed at strengthening the WHO’s emergency response capacity. While the panel demurred from advising the WHO on what programs it should cut, it did state firmly that responding to global health crises is one of the reasons the agency exists. About the Author Reprintscenter_img Dr. Peter Piot, one of the panel’s cochairs and director of the London School of Hygiene and Tropical Medicine, said the head of the proposed center for emergency preparedness and response should report directly to the WHO director general and should be shielded from political pressure.The panel said countries that report disease outbreaks promptly should be publicly praised. Those that hold back information that puts the world at risk should be “named and shamed,” Piot said.The report also advises the WHO to publicly criticize countries that impose unwarranted trade and travel restrictions during outbreaks; the fear of those kinds of reprisals encourages affected countries to hide rather than disclose.The report does not directly criticize Chan, who declared Ebola a global emergency two months after Doctors Without Borders warned the situation was out of control. Three members of the panel interviewed by STAT sidestepped the question of whether the report’s multiple references to the need for a strong WHO leader was an indictment of the current director general. They said the panel wanted to look forward, not back.“Member states should insist on a director general with the character and capacity to challenge even the most powerful governments when necessary to protect public health,” the panel wrote. Internal emails obtained by the Associated Press suggested that the WHO was reluctant to declare the outbreak an emergency, fearing it would antagonize the affected countries.The WHO said it is already working to address some of the shortcomings that were raised in the report as well as in earlier appraisals of its Ebola response. “There were operational problems in early 2014 and that is what the reforms at WHO are all about. We are building the capacities to do that and moving from a technical/political organization to an operational one,” the agency said in a brief emailed statement when asked to comment on the report.Chan promised reform at the UN health agency’s annual general meeting last May.“I have heard what the world expects from WHO,” Chan said in her speech opening the World Health Assembly. “As director general of WHO, I am committed to building an organization with the culture, systems, and resources to lead the response to outbreaks and other health emergencies.”Chan’s second and final term ends on June 30, 2017, and would-be successors are likely already positioning themselves. Whether WHO member states will want an assertive and proactive director general remains to be seen, though recent history provides some cause for doubt.Dr. Gro Harlem Brundtland headed the WHO during the 2003 SARS crisis. A former Norwegian prime minister, Brundtland made tough calls; under her, the WHO warned against unnecessary travel to China, Toronto, and other SARS-affected locations. The travel advisories were loathed by the countries named and won Brundtland no friends in their capitals. That tool has never been used since.“At the end of the day, countries are sovereign. They’re going to do what’s in their best interests,” acknowledged Dr. Ashish Jha, a panel cochair and director of the Harvard Global Health Institute. “But the reason we have entities like the WHO is to be able to act in ways that are necessary for the world’s health, even when an individual country is thinking narrowly about its own short-term interest.”There have been other recent attempts to reform the WHO, notably after the SARS outbreak and the 2009 flu pandemic — which left some countries arguing that the global health agency had overreacted. But those efforts stalled when policymakers’ attention shifted to new crises.With the waning of the Ebola outbreak and the recent attacks on Paris and Beirut, global security concerns may put global health reform on the back burner. But if the world lets this opportunity slip, it will “remain wholly unprepared for the next epidemic,” the panel wrote in its report.Said Jha: “I don’t think we have a choice on this. I think letting this one go is not only a disservice to the people who died unnecessarily in West Africa, but it represents a huge vulnerability for all of us going forward.” @HelenBranswell This story was updated at 5:10 p.m., Nov. 23.The World Health Organization must be overhauled and countries worldwide must reassess their roles if they are to protect against future crises such as the West African Ebola outbreak, according to a major report released late Sunday by a panel of international experts.The group, convened by the Harvard Global Health Institute and the London School of Hygiene and Tropical Medicine, called for a rebuilding of the WHO’s emergency response capacity, which has been crippled by funding cuts in recent years.advertisement Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. “The reputation and credibility of WHO has suffered a particularly fierce blow.” Tags Ebolaglobal healthWorld Health Organizationlast_img read more

Can detox waters really flush your fat and toxins away?

first_img Water does help to keep your liver and kidneys in tip-top shape. The body relies on the liver to pick up toxins from the bloodstream and convert them into water-soluable substances that can be excreted in urine. The kidneys help out, too. That’s a natural, everyday process, essential for life. Plain, old-fashioned water is a crucial ingredient to keep the system working. But adding cucumbers or mint doesn’t give the water extra power. And scientists say they don’t understand what special toxins the specialty waters are supposed to be helping you flush.“Nobody has really explained to me what toxins they’re getting rid of,” said Dr. Donald Hensrud, a nutrition researcher at the Mayo Clinic. “People talk about it as if it’s some big compound of chemicals we need to get rid of, and I’m not sure what they’re talking about.”advertisement Related: That hasn’t stopped companies from selling detox pitchers and water bottles, or bloggers from touting lists like “20 Delicious Detox Waters to Cleanse Your Body and Burn Fat.” Health celebrities have jumped on the trend, too. Oz brought fitness personality Kim Lyons onto his show to whip up some fat-flushing water. Michaels, the trainer on the popular TV show “The Biggest Loser,” shares a recipe for detox water she claims can help you lose up to five pounds in a week.The Kardashians are also on the bandwagon, with Khloe sharing her favorite detox water recipe (lemons, cucumber, mint) with her millions of Instagram followers. News Editor Detox waters are promoted by celebrities in the health and fitness world. Alissa Ambrose/STAT Celebrity selfies, lax regulations drive booming supplement industry HealthCan detox waters really flush your fat and toxins away? By Megan Thielking Jan. 5, 2016 Reprints Megan Thielking [email protected] Experts debate: Do we need tougher regulation of dietary supplements? Supermodel Miranda Kerr swears by another Dr. Oz-touted hydration trick — drinking warm water with lemon in the morning. Kerr has said the infused water “really helps kick up the digestion and it also cleanses the body and boosts the immune system.”Others promoting the health benefits of detox water claim that the body absorbs all the good vitamins seeping into the water from those orange and lemon slices, without the calories that come with actually eating a piece of fruit. “Basically, it’s like making your own ‘vitamin water,’ but without the cost or hidden ingredients,” the FAQ page on infusedwaters.com reads.But experts say it’s unclear how much benefit you’d actually get from drinking infused water.“The calories in there are minimal, though I’m not sure the water has no calories,” Hensrud said, “and that suggests that the other substances in there provide health benefits that are probably minimal, too.”Though they’re skeptical of the big claims, nutrition experts say detox waters aren’t harmful. And they may even have one benefit — they just may be tasty enough to get you to drink more plain, old-fashioned water. Slice and dice a few cucumbers, peel a tangerine and a grapefruit, toss in a few sprigs of mint, and you’ve got yourself a bona fide detox water, able to flush fat and toxins out of the body. At least, that’s what TV health personalities like Dr. Mehmet Oz and trainer Jillian Michaels have been touting. So, what makes detox water so magical?Pretty much nothing, scientists say.“More water makes the body’s job of flushing toxins easier,” said Cornell nutrition and chemistry professor Thomas Brenna, “but I can get that water from my tap.”advertisement Related: @meggophone About the Author Reprints Tags dietary supplementsnutritionweight losslast_img read more

How a stress-busting device with little science behind it ended up in a trailer park

first_img By Megan Thielking Nov. 18, 2016 Reprints HealthHow a stress-busting device with little science behind it ended up in a trailer park Related: The science behind the infrared saunas sweeping Hollywood Its first wearable device, priced at $199, promised to energize you with a few zaps of electrical pulses to the neck.Now, the startup Thync is developing a new model aimed at reducing stress. After sinking $30 million into research and development at Thync, the team set out recently to test the second-generation model — in a trailer park in Warren, Mich.It’s collecting some positive reviews. But the science behind the buzzy new technology?advertisement Thync twice.The sleek device — which, like the company, is called Thync — fires off low-level electrical pulses known, of course, as “Thync vibes.” Those electrical signals are sent through wired strips placed on the neck. Users can control the intensity using a smartphone app, choosing from among mood settings like “Bliss” or “Holiday Lights.”advertisement Related: The top comment: “This is an expensive device with mildly noticeable effects at best and the considerable ongoing expenses are clandestine.” (Such expenses include buying new strips to place on the neck each time the device is used.) “This technology is a long way away from being worthwhile,” the user concluded.Others, however, seem to have found success: “[First] time I used Bliss mode I was amazed,” one buyer wrote. “I felt like I had glass of scotch.”And how about the residents of Twin Pines Mobile Home Park? Are they likely to buy the product when it hits the market? Rupard said she’d like to continue using it to alleviate neck pain, but can’t.“Most of the people here are on Social Security or disability,” Rupard said. “Their income, they wouldn’t buy it. I wouldn’t be able to afford it.” [email protected] Tags mental healthplacebostress Privacy Policy @meggophone Even before getting the user reviews, however, Thync was promoting the experiment, sending the press dramatic black-and-white photographs showing weary-looking residents testing the device.Among them: Twin Pines resident Melissa Rupard, 48, who has struggled with back and neck pain her entire life and recently applied for disability. She was excited to test the device after receiving training from Shuster and a Thync employee. She’s used it about three times a day for three days and said it seems to have helped with her neck pain — though the device is marketed as a stress-reduction tool.“I woke up and my neck isn’t as bad is it was,” Rupard said. “It felt like I was getting a nice massage.”Goosens, the neuroscientist, said that might well be the case. The device covers a wide enough part of the neck to potentially massage sore muscles a bit. And the instructions do recommend that you relax while wearing a Thync — which can also be a natural means of stress reduction.“I’m sure if you have your feet rubbed, it’s probably also going to reduce your feelings of stress and anxiety,” she said.But Goosens said there’s no data to suggest the device can alleviate our most intense stress responses — the ones that are the most detrimental to our health. “I don’t necessarily buy their explanation,” she said. The company claims its device can be as powerfully relaxing as two Xanaxes.“It’s a fundamentally new way to change how you feel,” said Isy Goldwasser, the founder and CEO of Thync. Though Thync has published a safety study to show that the product won’t harm users, the studies Thync cites as evidence it’ll actually work are thin. One experiment, published last year in Scientific Reports, gave 20 patients either a sham device or the Thync product. The researchers then snapped thermal pictures of participants’ faces and found that temperatures varied between the two groups. Patients using Thync had higher temperatures in some spots on the face. The authors concluded that those higher temperatures were a sign of “increased positive emotional states.”Ki Goosens, a neuroscientist who studies stress at the Massachusetts Institute of Technology and who reviewed the study, called facial temperatures an “obscure” measure.“It looks to me like they don’t even have a stress response,” Goosens added. “The classic measure of stress, cortisol levels, had no effect.”The paper also includes data from 45 participants who used either the device or a sham product for one session. Those who used Thync reported slightly lower levels of anxiety and tension. There wasn’t any difference in the other five categories measured, including fatigue and depression.Goosens said the device most likely works through the placebo effect. “People who buy this would buy it expecting it to alleviate stress. Placebo effects against pain and stress are quite significant in human subjects,” she said.A test run in a trailer parkDetroit has a reputation as a stressful city, so Thync decided to test its new device, which is expected to hit the market next summer, somewhere in the area.The company sent Darren Shuster, a representative for Los Angeles-based Pop Culture PR, to find a good spot. Shuster hauled the prototypes to a dozen trailer parks looking for takers to participate in a weeklong test run. (Why trailer parks? Thync representatives reasoned that they would be among the more stressful places to live in an already stressed-out part of the country.)“We wanted real feedback and real experiences, not the stress of ‘The traffic is really bad today’ or ‘I’m having a bad hair day,’” Shuster said.Many people were skeptical — Shuster said he was chased out of one trailer park by a dog. He finally found a receptive crowd in Twin Pines Mobile Home Park in Warren. Shuster handed out Thyncs and iPods to about 30 residents. Those devices will be collected in a week’s time, once Thync has received feedback. Residents were paid $25 to come hear about the devices, and will receive another $75 when they turn the Thync prototypes back in. About the Author Reprints Related: Please enter a valid email address. Megan Thielking Can detox waters really flush your fat and toxins away? Will Whoopi Goldberg’s pot-infused bath soak ease menstrual cramps? News Editor Leave this field empty if you’re human: Mixed reviews onlineThere are implantable devices now on the market that stimulate the nerves directly to treat chronic pain. Thync, by contrast, isn’t approved to treat any actual medical condition. It’s regulated by the Food and Drug Administration as a non-invasive, battery-powered stimulator — solely for recreational use.“The way these devices work isn’t really well-understood,” said Jason Moehringer, a Maryland-based psychologist who conducted a literature review of the data on Thync and two similar devices.Thync’s product page on Amazon. Screen capture via Amazon.comThe initial product, which went on the market last year, has received mixed reviews. Goldwasser, the Thync CEO, said there’s an inherent variability in how such devices work for different people.“It’s like caffeine. If you take 10 people in your office, a few are going to be really sensitive and can’t have it past 2 p.m.,” he explained, “while a few can have it at any time.”Goldwasser estimated that the product is effective in 80 percent of users who pay close attention to the instructions and play around to get the placing and levels just right. But for the regular shopper who gives it a go just once to see if their stress is lessened, Goldwasser estimated efficacy falls to about 50 percent. He pointed to the product’s mixed Amazon reviews, some of which were written by individuals who received a free Thync to try in exchange for posting feedback. A man wears a Thync devices on his neck at the Twin Pines Mobile Home Park in Warren, Mich. Darren Shuster for Thync Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day.last_img read more

Mylan, like other generic drugmakers, feels the pricing pain

first_imgBusinessMylan, like other generic drugmakers, feels the pricing pain Mylan and its rivals that make generic drugs have been under pressure because of falling prices.Mylan is also dealing with a decline in sales for its EpiPen Auto-Injector, following a decision to start selling a lower-priced generic version. That decision was made after the cost of the devices drew scorn from parents nationwide and spawned Congressional inquiries.“Given the region’s ongoing challenges and the uncertain U.S. regulatory environment, we have elected to defer all major U.S. launches from our full year 2017 financial guidance to 2018, including generic Advair and generic Copaxone,” said CEO Heather Bresch. “As a result, we now expect to deliver total revenues this year of between $11.5 billion and $12.5 billion.”The previous projection from Mylan was for revenue of between $12.25 billion and $13.75 billion. Mylan may have overcharged taxpayers by $1.27 billion for EpiPens, HHS says Jeff Swensen/Getty Images Related: By Associated Press Aug. 9, 2017 Reprints Mylan offered EpiPen discounts to states in exchange for privileged status, documents show Per-share projections released Wednesday of between $4.30 and $4.70 are also down from earlier expectations of between $5.15 and $5.55.The expectations for all of fiscal 2018 were also trimmed, from $6 a share, to $5.40 a share.Citi analyst Liav Abraham said that Mylan’s struggles mimic earlier quarterly reports from others in the generic industry.“This morning’s earnings, while consistent with the larger generic players thus far (TEVA and Sandoz in particular), are nonetheless not particularly reassuring, and point to structural issues in the US generics landscape,” Abraham wrote.Mylan shares have declined 17 percent since the beginning of the year. Associated Press Related: Earnings, adjusted for non-recurring costs, came to $1.10 per share, well below the per-share estimates of $1.18 that Wall Street was seeking, according to a survey by Zacks Investment Research.Revenue surged 15.6 percent to $2.96 billion on higher sales in Europe, largely due to products now owned by Mylan after its buyout of the Swedish drugmaker, Meda. However, that too was short of analyst expectations.advertisement About the Author Reprints NEW YORK — Mylan’s second-quarter profit and revenue surged, but not as much as Wall Street had expected and the company is taking a more conservative view going forward because of “ongoing challenges and the uncertain U.S. regulatory environment.”Shares tumbled 5 percent and were trading close to four-year lows at the opening bell Wednesday.The generic drugmaker, which is incorporated in the United Kingdom but has its U.S. headquarters outside of Pittsburgh, said profit surged 76 percent to $297 million, or 55 cents per share.advertisementlast_img read more

Two little girls, two similar paths to medicine, but one difference: immigration

first_imgOff the ChartsTwo little girls, two similar paths to medicine, but one difference: immigration By Jennifer Adaeze Okwerekwu Sept. 8, 2017 Reprints Related: But Raquel is a DACA recipient, and she told me on Wednesday that she is worried. How could she not be? If Congress or the president doesn’t act, her career is at stake, and our profession could lose the work of yet another primary care doctor.advertisement Related: Earlier this week, President Trump moved to end DACA, Deferred Action for Childhood Arrivals, an Obama-era policy that allows undocumented children who came to the U.S. with their parents a deferral on deportation and the ability to work. On Thursday, he tweeted that DACA recipients have “nothing to worry about” — for now.For all of those (DACA) that are concerned about your status during the 6 month period, you have nothing to worry about – No action!— Donald J. Trump (@realDonaldTrump) September 7, 2017 First wave of undocumented immigrants in medical schools face uncertain future Jennifer Adaeze Okwerekwu @JenniferAdaeze I’ve been thinking a lot lately about two little girls, one 6 and the other 8.Both girls came to America with their parents, who were looking for better opportunities in health care. Both girls watched their parents navigate the American health care system — in one case, as a patient in need of advanced medicine, and in the other, as providers in a profession uneasily reliant on immigrant doctors. Both girls took those experiences to Harvard, and then medical school, and finally, residency, serving patients from disadvantaged backgrounds.We’re basically the same, Raquel and I. We’re both American. We really don’t know any other country as our home. The only difference is that my family had visas, and then I became an American citizen. Raquel’s family didn’t.advertisement About the Author Reprints DACA recipients, also called “dreamers,” and undocumented people in the American health care system contribute to our nation in immeasurable ways, not the least of which is community health, Raquel’s calling. When it comes to people like her, I can’t help but wonder why America is trying to bite the hand that heals it.Raquel is unsure what comes next. Should nothing be in place for her to renew her work permit, she’s hoping the hospital she’s working for, and her residency director, will help her. She told me, “I would be willing to work for free to finish.”I really admire her. Raquel was one of the first undocumented medical students to match into residency under DACA. She has really pioneered uncharted waters. And she recognizes that it’s a bit of luck and timing that she happened to qualify for DACA in the first place — other children of undocumented adults, she said, for whatever reason, aren’t protected, and they should be.To that end, she’s started a nonprofit called fundscholar.org to help other students caught in immigration crosshairs get to where they want to go, or, she said, “just to have someone be supportive … that is important.”center_img “Though it is concerning, it sucks more for the communities rather than the actual applicants,” Raquel told me, referring to the financial and emotional stability that children like her provide for their communities.True to her childhood experience, Raquel chose family practice for her residency, partly because she wanted to do it, but also because the residency can be completed in just three years, so the likelihood that she might not finish because of immigration issues was lessened. Related: Trump should consider the health consequences of immigration policy, not just economics ‘The fallout has been all around me’: How becoming a doctor has taken a mental toll Mike Reddy for STAT Tags educationphysician Columnist, Off the Charts Jennifer Adaeze Okwerekwu is a psychiatrist and a columnist for STAT. [email protected] She’s so right.Two little girls came to the U.S. with their parents. Both saw the role of community medicine in building health. Both lived in a country that expected more from them as women of color than other people, and both rose to that challenge. Both have struggled to find support in a medical system still trying to be more integrated, diverse, and inclusive. And, both have made it their life’s work to give back to the people in this country who need help the most.Yet, I get to pursue my dreams without fear of having to leave suddenly. I get to go to work each day, focused on my patients, focused on their health and well-being, and focused on becoming the best doctor I can be. I get to be an American, all the time, without question. Because of security I get from holding a U.S. passport.Something here just isn’t healthy. The president’s decision threatens to derail even this safety plan. DACA gives her a renewable work permit, and it expires just before her residency ends.Raquel and I matched into residency the same year. I’m asked multiple times a week about my plans for my career. Raquel’s dilemma has made me realize that my ability to freely design my own destiny is a luxury, one she said the ticking clock of her immigration status doesn’t afford her.Without DACA, or something akin to it, she may lose her right to work. If she doesn’t finish her residency, her options in the U.S. are limited. If she has to leave the country, she said she worries more about who she’ll leave behind.Raquel is frustrated. Her immigration status is always in the back of her mind, she said. She has little faith in the government she reluctantly trusted when DACA was put in place, when she handed over all her personal information for that work permit, for that residency, and for the ability to become a doctor in the only country she’s ever known.“I want to devote as much time as I can to the patients, and the work that I’m doing, and this is always happening on the side,” she told me at the end of a long evening in a mobile clinic in California, where she is based. We talked about the DREAM Act, legislation that would lessen immigration uncertainty for her and so many other medical students. It’s been bouncing around Congress in one way or another since we were in junior high. “Congress has had 16 years to work something out. I would be shocked if something were done in the next six months.”Becoming a doctor is one of the hardest things I’ve ever done. The demands of education and training have dominated my near 30 years of life and I can’t imagine being so close to the finish line and then being disqualified at the last second. It makes no sense on both an emotional and practical level.last_img read more

Pharmalittle: Allergan CEO says Mohawk deal wasn’t ‘desperation’; pharma layoffs are rising

first_imgPharmalot Pharmalittle: Allergan CEO says Mohawk deal wasn’t ‘desperation’; pharma layoffs are rising @Pharmalot Hello, everyone, and how are you today? We are doing just fine, thank you, despite the gloomy clouds hovering over the Pharmalot campus. Sunny spirts are in order because, as the Morning Mayor schooled us: Every brand new day should be unwrapped like a precious gift. Words to live by, yes? While you think it over, please join us for yet another delicious cup of stimulation. And of course, here are your tidbits. Have a wonderful day and do keep in touch …Allergan (AGN) chief executive officer Brent Saunders told Mad Money there has been “a lot of misunderstanding” about the controversial deal to transfer Restasis patent rights to the St. Regis Mohawk tribe. “It wasn’t desperation, it was tenacity. … And I think people got confused that said because I believe in strong intellectual property, I don’t believe in making medicines affordable and accessible, and one has nothing to do with the other.” Alex Hogan/STAT Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints What is it? What’s included? GET STARTEDcenter_img By Ed Silverman Nov. 2, 2017 Reprints 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. Tags jobslegalpharmaceuticalspharmalittleSTAT+ Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] last_img read more

Why do medical journals keep taking authors at their word?

first_img The recent revelation that a leading official at Memorial Sloan Kettering Cancer Center failed for years to disclose lucrative financial conflicts of interest might have been surprising in its scale. But it’s old news that many researchers aren’t fully transparent when it comes to their financial relationships with industry.So why should we keep up the charade? And why, given the clarity of the problem, do medical journals continue to take authors at their word — only to wind up looking like dupes?According to an investigation by ProPublica and The New York Times, Dr. José Baselga — who was chief medical officer of the venerable cancer clinic until resigning Thursday — has what can charitably be described as an inconsistent personal policy on revealing companies that have given him cash or other potentially lucrative fillips. Baselga also has stayed mum about his conflicts of interest — which also involve research funding and seats on advisory boards — in many of his publications, including those in high-rent titles like the New England Journal of Medicine, and despite policies from the journals demanding that authors reveal such relationships.advertisement So as a first step, journals should publish those forms. Second, just as nearly every publisher now screens submissions for evidence of plagiarism, it’s time the journals do the same for conflicts of interest.Journals already have some of the tools they need to look for conflicts. A 2010 law, the Physician Payments Sunshine Act, established a government database called Open Payments to disclose industry payments to physicians. Dollars for Docs, from ProPublica, also tracks these ties. However, neither database, as Matthew Herper at Forbes has noted, catches participation on corporate boards or work on drugs or devices that the Food and Drug Administration hasn’t yet approved. Nor do they include patents for relevant discoveries, which a comprehensive repository should house.The Baselga affair and others illustrate how flawed the system is, but even when journals do learn of undisclosed conflicts of interest, they tend to respond weakly. Although the Committee on Publication Ethics says failure to disclose a major conflict of interest can be grounds for retraction, journals almost always choose to issue corrections instead. At the time of this writing, our database of retractions shows 114 removals of papers for undeclared conflicts of interest, less than 1 percent of the more than 18,000 total retractions, and most of those include other reasons without which the article more than likely wouldn’t have been retracted. That sends the message to authors and readers alike that journals don’t take these issues seriously.It seems clear, then, that it is time to take this responsibility away from journals, or at least add another layer. What’s needed is a single pool of conflicts data — one that captures cash payments, patents, stock holdings, board seats (both corporate and foundations), funding sources for research — against which editors can screen authors. Given that unscrupulous or indifferent authors are likely to omit potential conflicts, the burden of tracking them on an individual level must be as automated as possible. The names of authors would be linked to their entries in the database, so any reader could click and judge what’s relevant and what isn’t. Dr. José Baselga Memorial Sloan Kettering Cancer Center via Creative Commons Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson The WatchdogsWhy do medical journals keep taking authors at their word? We note that this will not be a simple task, and would probably be best tried as a pilot program first, in a small area of research, with some government or foundation funding. The system also needs some sticks. Journals could let authors know that if they find out about relevant conflicts later, they won’t publish work by that author until the database is complete. A version of that approach has worked when it comes to pre-registration of clinical trials, although it took an act of Congress to really cement that incentive — and as STAT has shown, sharing data itself on that platform isn’t quite there yet.Of course, and this point is critical, a disclosed — or even an undisclosed — potential conflict of interest does not necessarily mean that a study, guideline, or bit of clinical advice is unreliable. Indeed, scientists often are highly sought after by industry because they have a reputation for integrity, fairness, and expertise in their field. Yet evidence shows that physicians who take money from industry are more likely to prescribe brand-name (and therefore more expensive, generally) medications. And, as ProPublica found, the more money, the greater the effect on prescribing habits.But as the ethicist Art Caplan of New York University tweeted in response to the Baselga news: “We have yet to figure out what [conflict of interest] means or how to manage it in a health care world where industry ties are everywhere.” The trick, to paraphrase Bruce Springsteen, is not to be blind to those ties that bind. Related: Journals that don’t publish such forms are telling readers that the only judgment of whether a conflict is relevant is theirs. They’re also leaving it unclear whether — when a conflict such as Baselga’s is found — it was the author who didn’t declare it, or the journal that didn’t find it important enough to mention.advertisement By Ivan Oransky and Adam Marcus Sept. 14, 2018 Reprints Authors of premier medical textbook didn’t disclose $11 million in industry payments To be fair, some of the reason we know that Baselga wasn’t fessing up was because some journals — including the NEJM — publish conflict-of-interest disclosure forms that authors submit. That’s not a uniform practice; the Journal of the American Medical Association doesn’t, and in at least one case declined to release the form when pressed by a reporter. Trending Now: Tags ethicsphysicianslast_img read more

Drug ‘rebate walls’ should be dismantled by the FTC’s antitrust arm

first_imgLeave this field empty if you’re human: We need tangible action to avert such mischief designed to protect monopoly positions by drug companies that provide no benefit to patients but serve only to increase profits for drug companies and payers alike.The FTC is uniquely equipped to investigate, demand answers, and push for change to stop contracting practices that increase the cost of care and reduce access to more affordable and effective treatments. Given the competitive risks posed by rebate walls, the FTC should immediately address this suspect contracting practice by opening investigations into exclusionary rebates, multi-product and indication rebates, and conditional pricing discounts. Doing so can help tear down the rebate wall and allow new drugs open and fair access to the market and consumer access to cost saving treatments. If the FTC discovers that the alleged pricing practices are having an anticompetitive, exclusionary effect, it should bring its own enforcement actions.Appropriately targeted investigations by the FTC are essential to protecting competition in prescription drug markets.David Balto is a public interest and antitrust lawyer who served as the policy director of the Federal Trade Commission’s Bureau of Competition in the late 1990s, where he helped design and implement the commission’s pharmaceutical enforcement program. He now advocates for consumer groups on health care competition issues. By David Balto Dec. 4, 2018 Reprints Rebate walls distort the workings of the free market, result in higher drug prices, and reduce patients’ access to affordable branded drugs.Rebate walls are particularly insidious because incumbent drug manufacturers — those that have dominant positions with a drug that has been in the market for years — enter into exclusionary contracts and structure rebates among a wide set of their products or indications to limit competition from new rival branded drug manufacturers that cannot provide the same range of products or indications in a bundled rebate.By extending rebates to several products or indications, a firm is effectively penalizing a payer that chooses an alternative innovative branded drug. In other words, when a rebate wall is erected, payers simply do not have the economic incentive or ability to switch to a new and improved rival drug that provides a more cost-effective treatment. Why not? Because the monetary penalty for doing so — losing their rebates not only on the incumbent branded drug but on all the products or indications with which the rebates are bundled — is too high.Some payers have claimed that the rival branded drug could be provided for free and the numbers still would not justify switching. Ultimately, rebate walls tie payers’ hands so they cannot choose a less expensive or more effective product. In addition to hurting patients directly, rebate walls raise the cost of health care. Related: Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. First OpinionDrug ‘rebate walls’ should be dismantled by the FTC’s antitrust arm [email protected] Naturally, the payers pocket the rebates in an effort to maximize revenue streams without passing all of the discounts they receive on to consumers. As Nicholas Florko and Ed Silverman noted in their recent STAT article on biosimilars, conditional discounts to a payer on a portfolio of drugs creates a rebate trap because if the payer was to purchase a competing drug, it would lose its discounts on the entire portfolio of drugs.advertisement Adobe Both the Trump administration and the industry recognize this practice as anticompetitive. Earlier this year, Department of Health and Human Services Secretary Alex Azar told the Senate Health, Education, Labor, and Pensions Committee, “I am very much aware that these rebate walls can prevent competition and new entrants into the system. … I do not like that practice. I think it’s using their market power in ways that are not appropriate. I want to make sure we are looking at that. I think Congress could look at that question as part of this whole initiative.”Vas Narasimhan, chief executive officer of Novartis, has called for action, stating that “we need to tear down the rebate wall and create better contracting models that help patients access” cost-saving treatments. Several major drug manufacturers, including Pfizer and Shire, have filed antitrust suits challenging rebate walls as antitrust violations.The rebate wall practice relates to how branded drug manufacturers get on payers’ preferred drug formularies. In theory, these rebates could have a positive impact if they benefited consumers through lower prices. But in practice this is simply isn’t the case. These deals are often structured in ways that handcuff payers so they can’t choose a lower-cost drug or a better one.This is illustrated by the Pfizer and Shire cases. Because of rebate walls, Pfizer was unsuccessful in marketing Inflectra, a lower-cost immunosuppressive biosimilar used to treat Crohn’s disease, rheumatoid arthritis, and other conditions. It was in competition with Johnson & Johnson’s Remicade. The rebates for Remicade were allegedly bundled with other Johnson & Johnson products, which disincentivized insurers from reimbursing for Inflectra and providers from purchasing Inflectra or other biosimilars. Shire was unsuccessful in penetrating the Medicare Part D market with Xiidra, used to treat dry-eye disease, which by all accounts is a better alternative than Allergan’s Restasis. Allergan’s rebates on Restasis were bundled with a broader portfolio of drugs so Medicare Part D plans lacked the financial incentives to purchase Xiidra instead of Restasis. While policymakers are giving considerable attention to escalating drug prices and ways to rein them in, the Federal Trade Commission needs to use its muscle by opening antitrust investigations and bringing enforcement actions against pharmaceutical manufacturers where necessary.It can start by addressing a questionable contracting practice in the pharmaceutical industry known as a rebate wall or rebate trap. Although “rebate” sounds like something that should benefit consumers and result in lower prices, there is increasing evidence that rebates from pharmaceutical manufacturers to pharmacy benefit managers and others have actually inflated the price of drugs and stifled the ability to compete by rival manufacturers of less expensive drugs to compete.As Robin Feldman wrote in the Washington Post last week, “the system contains odd and perverse incentives, with the result that higher–priced drugs can receive more favorable health-plan coverage, channeling patients toward more expensive drugs.”advertisementcenter_img Related: Rebate walls work like this: A drug manufacturer that has established a dominant position in the market, say with a blockbuster drug, provides to payers (pharmacy benefit managers, health insurers, and providers) conditional rebates and discounts off the list price for a multi-product bundle of drugs or indications. The drug manufacturer uses the bundled rebate to protect its already established position with the payers. As Feldman put it, “the name of the game is volume. The more volume a drug company has with a particular PBM or hospital, the better deal it can offer as a temptation to exclude rival drugs.” David Balto About the Author Reprints Rush to end drug rebates may be bad for patients, payers, and pharma Please enter a valid email address. You have questions on biosimilars. We have answers Privacy Policy Tags drug pricinggovernment agenciesinsurancelast_img read more

China creating national medical ethics committee to oversee high-risk clinical trials

first_img Great Hall of the People in Beijing FRED DUFOUR/AFP/Getty Images Tags biotechnologyChinaCRISPRethicsSTAT+ What’s included? About the Author Reprints BEIJING — A powerful new national medical ethics committee, which will approve all clinical trials involving high-risk biomedical technologies, is at the center of a regulatory shakeup Chinese authorities are planning in the aftermath of the widely condemned “CRISPR babies” experiment, STAT has learned.The technologies that will be regulated by the ethics committee are often new and are deemed risky either because of safety or moral concerns. They will include not only gene editing, but also cloning, cell therapy, xenotransplantation, mitochondrial replacement, and nanotechnology. GET STARTED Jane Qiu 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. 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. Exclusive By Jane Qiu March 5, 2019 Reprints China creating national medical ethics committee to oversee high-risk clinical trials [email protected] @janeqiuchina Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTEDlast_img read more

Doctors Without Borders blasts coalition working on vaccine development

first_imgPharmalot Ed Silverman By Ed Silverman March 15, 2019 Reprints Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED [email protected] @Pharmalot Log In | Learn More Doctors Without Borders blasts coalition working on vaccine development A feud has broken out between the Coalition for Epidemic Preparedness Innovations and Doctors Without Borders, which accused the public-private coalition devoted to vaccine development of watering down a policy for equitable access to any treatments.Despite several pleas by Doctors Without Borders, CEPI declined to reinstate portions of its original access policy. The guidelines were adopted at the time the coalition was created in 2017 in the wake of the Ebola virus, with backing from the Bill and Melinda Gates Foundation and several governments, among others. What is it?center_img Carolyn Kaster/AP Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. About the Author Reprints Tags public healthSTAT+Vaccines 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’s included?last_img read more