UAB Recruiting for Clinical Trial to Determine Therapies for Eradication of Multiple Myeloma –University of Alabama at Birmingham

Explanation: This news release about a test of combination drug therapy in people newly diagnosed with multiple myeloma blood cancer slathers on hopes and promises, while neglecting caveats, potential harms and essential context. The release neglects to point out that even after this phase 2 trial has been completed, researchers won’t know if the experimental drug cocktail is better or worse than standard treatments, because it does not include any direct comparison. The release puffs up the threat of multiple myeloma, which accounts for less than 2 percent of cancer cases in the US. It does not explain that patients would be responsible for many of the costs of this treatment, in part because of overlaps with standard care. The release does report support from pharmaceutical companies that make two of the drugs to be used. The lead investigator of this trial, Luciano Costa, MD, gave an interview in which he clearly pointed out much of the important information that is missing from the news release. The interview shows that the researchers are aware of the limitations of the evidence and of their trial. Costa pointed out that patients considering enrolling would be responsible for a share of the costs of treatment. Researchers have a responsibility to ensure that news releases issued about their work give readers a fair summary, not the kind of rosy depiction in this release. It’s also important to point out that this is a phase 2 trial, which identifies safety and effectiveness of a treatment. The primary endpoint is a surrogate that is not clearly associated with overall survival for this disease.

In some experiments, it may be too early to discuss treatment costs, but this trial involves drugs that are all already approved for other uses, which means their prices are known. Also, while trial participants typically are not charged for experimental drugs, in this case it appears they will be billed for many treatment costs… and there would likely be costs for some (including travel and  lodging) that insurance would not cover. In fact, the lead investigator acknowledged the costs when asked in an interview about what patients should know about the trial: “[T]he study, like any other clinical trials, that our components are considered standard of care and they are charged to the patient or to the insurance. For example, the costs of seeing the doctor, the cost of doing the main test for a traditional disease assessment, the cost of stem cell transplant, but there are components that are considered experimental and are covered by the study, in this case, the daratumumab, the carfilzomib and the MRD testing by itself.” The release should have also noted these costs. By definition, the benefits of an experimental treatment are unknown. The release should not dangle the potential of unproven benefits, including eradicating multiple myeloma, without acknowledging that this experimental treatment may turn out to be no better, or even less beneficial, than standard treatments. In the interview mentioned above, the lead investigator noted, “There is no proof that a new therapy is better, otherwise would be no need for the clinical trial.” The release should have included that fundamental caveat. We think it’s important to stress that a trial to determine the best therapy would ideally compare  National Comprehensive Cancer Network (NCCN) recommended treatments such as revlimid, dexamethasone and velcade with a proposed therapy. There is no mention of risks or harms of the experimental approach, but part of the function of a phase 2 trial is to evaluate harms. Not only does each drug in the experimental cocktail include its own risks (including increased risk of heart attack and stroke, nerve damage, blood clots, low white blood cell and platelet counts, fatal spikes in blood pressure), but the effect of the combination of drugs could exacerbate the harms or even create new ones. While multiple myeloma patients may be aware of and acknowledge the risks of individual drugs as part of standard treatment, the unknowns of the experimental drug combination should have been pointed out in the release. Although the news release notes that this is a phase 2 clinical trial, it should have pointed out that because the trial does not directly compare the experimental treatment to standard care, another (phase 3) trial will be needed to test whether the experimental approach is better (or worse) than standard care. The release cites an accurate number of new multiple myeloma cases (more than 25,000/year), but the lead phrase “Multiple myeloma is the second most common type of blood cancer in the United States” creates an exaggerated impression. The American Cancer Society calls multiple myeloma “a relatively uncommon cancer.” The ACS estimates it accounts for about 2 percent of all cancer cases and deaths. The release reports that this trial is supported by Amgen and Janssen, makers of two of the drugs it uses. (Executives at Janssen may not be happy that the release misspelled the company’s name as “Janseen”.) The disclosure would have been more complete if it had noted that the lead investigator, Luciano Costa, MD, PhD, has also received speaking fees and other personal payments from Amgen and Celgene (which sells another one of the drugs being tested). The release repeatedly touts the promise that this experimental therapy will prove to be superior to standard treatments, without clearly stating that even after this trial is done the answer to that fundamental question won’t be known, because there is no direct comparison. What’s more, the release highlights problems with and risks of standard care, even as it neglects the potential risks of the experimental treatment. The release notes that the trial uses drugs that are already available, though some are approved for only patients who have relapsed after initial treatment. It makes clear that the “minimal residual disease” testing regime to be used is not routinely available. Most readers of this release will get the impression that this trial is unique, when actually several groups are testing the same drug combination. The release highlights the researchers’ plan to use “next generation sequencing technology to detect minimal residual disease” (MRD) and to use those MRD results to guide treatment. There is much discussion of using MRD to monitor response to therapy but it is certainly not ready for widespread use. Some of the other similar trials also track minimal residual disease, though a quick review of trial descriptions on www.ClinicalTrials.gov does not make clear whether this trial is unique in using the MRD test results to guide treatment decisions or whether this feature is important. Similar trials include: A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma Selinexor and Backbone Treatments of Multiple Myeloma Patients Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant 2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy A quote from the lead investigator captures how this release dangles promises that go well beyond the evidence: “I believe for the first time that we have treatments that are effective enough to make it possible to eradicate multiple myeloma definitively in a substantial proportion of patients, along with having the technology to detect that the disease has been targeted and that treatment can be stopped,” said Luciano Costa, M.D., Ph.D. In the interview noted above, Costa was careful to note that there is no proof this approach is better than existing treatments. The release should have highlighted similar basic caveats.


Images depict the effects of lax immigration laws on California.

Explanation: Do Four Photographs Show the ‘Sunny Sanctuary State’ of ‘Once Beautiful California’?

On April 24 2019, a Facebook user shared the following images and status update (archived here), purportedly showing images from California that included piles of trash on a beach and by roads and trails:In the status update (“Welcome to the Sunny Sanctuary State of Once Beautiful California”), the user heavily implies the images here show standard sights and situations which directly resulted from California’s supposedly lax immigration laws.At the top of the four-image set is a photograph of a man riding a bicycle on a road surrounded by debris. The same image accompanies a March 2018 opinion item published by the Los Angeles Times, and its caption reads:A bicyclist rides past trash piles from the Santa Ana River homeless camp after it was cleared and more than 700 people relocated in Anaheim in February [2018]. (Los Angeles Times)From the little information provided in the caption, it appeared that the photograph depicted a specific event (the relocation of 700 homeless people in February 2018) versus business as usual for the area. A March 2018 Orange County Register article featured slider images of before and after the residents were moved, and a previous piece by the same organization chronicled the effort to move the approximate camp’s residents. Newsweek reported that the eviction of a three-mile long encampment “led to the removal of over a thousand pounds of human waste, 5,000 needles and about 250 tons of trash.”The photograph on the bottom right of the Facebook post shows a California beach, and that is where the accuracy of its description ends. This photo originally appeared in a February 2019 Orange County Register story about the aftermath of a storm at Seal Beach. Once again, the article (“After storms, Seal Beach looks like a landfill blanketed with trash”) had absolutely nothing to do with immigration, and that outlet explained why debris littered the shore:During dry summer months, pristine Southern California beaches draw millions of visitors. But during the wet season after heavy storms, the beaches can look more like landfills as trash travels down waterways, onto the sand and into the ocean. The trash was a familiar sight along the coast, especially where inland rivers met with the ocean.The area along the San Gabriel River, which borders Seal Beach and Long Beach, can be especially littered after it rains. The mouth of the river funnels runoff from 52 inland cities straight into the ocean, with trash and debris flowing down storm drains.A photograph on the bottom middle of the post did not even show California — or anywhere in the United States, for that matter. It was taken in Jakarta, Indonesia in either February 2016 or 2017. Captions for the image read:Tourists walk among trash washed ashore by strong currents at Kuta Beach in Bali on Feb. 15, 2017. (Antara Photo/Wira Suryantala)Trash washed up on Bali’s Kuta beach on February 2016. Reuters/Antara News AgencyFinally, the image at the bottom left was a stock photograph taken on January 26, 2018 in Los Angeles. Its caption read:Trash lies beside the Skid Row City Limit mural as the city begins its annual homeless count in Los Angeles, California on January 26, 2018. [Thousands] of volunteers will fan out across Los Angeles County during the three-night count of homeless people whose population is estimated to be nearly 60,000 strong. / AFP PHOTO / Mark RALSTON (Photo credit should read MARK RALSTON/AFP/Getty Images)That image accompanied an October 2018 LAist piece about ongoing tensions between Skid Row’s homeless population and quality of life enforcement efforts undertaken in the area, titled “Is LA Really Going To Federal Court To Argue It Can Seize And Destroy Homeless People’s Property?” A then-recent lawsuit filed on behalf of the area’s homeless population was described in the article:One of the plaintiffs, Carl Mitchell, claims the city confiscated and destroyed his possessions, following his arrest for allegedly stealing a shopping cart. He says he was released from police custody 18 hours later on a 40 degree winter night without his blankets, medication, and identifying documents. According to court documents, Mitchell slept that night on the sidewalk beneath a single blanket he found on the street, with no way to keep warm.Another, Judy Coleman, alleges that she developed pneumonia after the city impounded her blankets, medication, and walker.A month after the case was filed [in March 2016], a federal judge issued a restraining order against Los Angeles that effectively barred the city from conducting homeless encampment cleanups on Skid Row.As further detailed in the piece, tensions between homeless residents in the area and police persisted for years. Frequent “cleanups” of their encampments led to images such as the one seen in this post, but once again that image depicted a specific event — a “homeless count” done once a year in the greater Los Angeles area. An “About” page for the Greater Los Angeles Homeless Count explained:Every year, we conduct a census of the homeless population through the Greater Los Angeles Homeless Count. There are four components to the Count. Each of these components plays a vital role in understanding the state of homelessness in Los Angeles[. ][…]The Los Angeles Homeless Services Authority (LAHSA) is a joint powers authority of the city and county of Los Angeles, created in 1993 to address the problems of homelessness in Los Angeles. LAHSA is the lead agency in the HUD-funded Los Angeles Continuum of Care, and coordinates and manages over $300 million annually in federal, state, county, and city funds for programs providing shelter, housing, and services to people experiencing homelessness. Since 2005, LAHSA has coordinated the Greater Los Angeles Homeless Count.According to both the image’s caption and LAHSA, the photograph was taken on the night of the yearly census of homeless people in the Greater Los Angeles area.Of the four photographs seen in the viral Facebook post, two (the top and bottom left) showed specific instances of cleanup, relocation, or census-taking of homeless Californians, not immigrants. Neither image was associated with immigration or California’s immigration laws in any news reporting. The center bottom photograph was taken in Indonesia and had nothing to do with California. The remaining image depicted Seal Beach after a storm and showed the effects of plastic pollution, not homelessness or immigration. All four were taken out of context in an attempt to make a point, which fell apart completely when we traced the actual origin of the images.


Lawyers making final pitches in Flint water criminal case.

Explanation: A judge is hearing key arguments in the most significant criminal case related to Flint’s lead-contaminated water.

Health, Trials, Michigan, Legionnaires disease, Crime, Flint, Disease outbreaks

The head of Michigan’s health department, Nick Lyon, is charged with involuntary manslaughter and other crimes. He’s accused of not timely alerting the public about a Legionnaires’ disease outbreak in the Flint area in 2014 and 2015. Some experts have tied the outbreak to Flint’s poorly treated water. Legionella bacteria can emerge through misting and cooling systems. Judge David Goggins must decide whether there’s enough evidence to send Lyon to trial. He’s hearing arguments Wednesday and July 25. Special prosecutor Todd Flood says Lyon showed “willful disregard” for Flint-area residents. But Lyon’s attorneys have questioned the causes of death of two people cited by Flood. John Bursch says there’s “not even close to enough evidence” to put Lyon on trial.


China's tobacco monopoly means big risks for e-cigarette startups.

Explanation: In a glass-walled laboratory, chemists puff on vaping devices as they test liquid nicotine flavors. Nearby, staffers with cartons of instant noodles on their desks tap away at laptops, messaging suppliers and customers.

Here at the Shenzhen offices of e-cigarette start-up RELX Technology, workers scramble to keep pace with the rush of firms vying for sales in the world’s biggest tobacco market. Their potential-customer base starts with 300 million Chinese smokers of traditional cigarettes – about nine times the number in the United States. Founded by former employees of Didi Chuxing, China’s answer to Uber, RELX aims to become China’s answer to Juul Labs Inc, the San Francisco startup that captured a huge share of the U.S. vaping market with a sleek and addictive e-cigarette. RELX makes an almost identical product: a stick-shaped device that burns high-nicotine liquids packaged in plug-in “pods.” But it won’t have to compete with the U.S. e-cigarette giant. Juul has yet to crack China’s market even as it aggressively expands elsewhere in Asia and faces a regulatory crisis in the United States here over a surge in youth vaping. Juul’s delayed entry into China – potentially its most lucrative market – underscores the complexity and risk of operating here. E-cigarette sales have grown slowly in China compared to other industrialized nations. Its market is about one-ninth the size of the United States, according to market research firm Euromonitor. One main reason: China Tobacco, which is both the government-owned cigarette company and the national tobacco regulator. The state monopoly has not clearly signaled how it will regulate e-cigarettes – or whether it will sell them. If it does, it has the power to regulate its competitors out of the business. One investor in a Chinese e-cigarette startup likened the combined regulatory and competitive threat to “a knife on the neck.”  China Tobacco did not respond to written questions from Reuters. The cigarette giant’s power stems in part from its contribution to the national purse - accounting for 5.45% of China’s tax revenue in 2018. That amounts to 10.8 trillion yuan ($1.5 trillion), according to calculations by Professor Rose Zheng of the University of International Business and Economics in Beijing. Still, China Tobacco sells cigarettes for a fraction of what they cost in most nations – as little as 3 yuan per pack, or less than half a U.S. dollar. RELX sells a device and one pod for between 299 yuan to 399 yuan. Foreign firms, particularly U.S. firms, face the additional obstacles of the U.S.-China trade war, cultural challenges in marketing and distributing, and competition from a host of new Chinese e-cigarette startups including RELX, which was valued at $2.4 billion based on recent investments. In September, Juul briefly started selling devices on two popular online commerce sites, Tmall and JD.com Inc. But the products were pulled from the websites days later for unknown reasons. Juul, Tmall parent company Alibaba Group Holding Ltd, and JD.com declined to comment on the Juul product removals or China’s regulatory environment. China Tobacco issued a notice Nov. 1 urging e-commerce platforms and e-cigarette companies to shut online stores offering vaping products, a move aimed at stopping youth sales. Juul declined to comment on its China strategy. RELX CEO Kate Wang said she’s “not worried” about the government’s impact on the sector. The products will continue to remain available, she said, “as long as there’s proof that this is a good solution for smokers.”  Many e-cigarette startups still see boundless opportunity in China. Nearly half of Chinese men smoke cigarettes, according to the World Health Organization. Chinese factories make 95% of the world’s e-cigarettes, according to Electronic Cigarette Industry Committee, a Chinese trade association. But almost all of that production is exported. Juul’s explosive U.S. growth only recently convinced Chinese e-cigarette firms of the viability of small, high-nicotine vaping devices in China. They had focused on larger, box-shaped devices that spew vast clouds of vapor and spawned a subculture in the Chinese hip-hop community. The box vapes were less effective in delivering nicotine but offered better profit margins, said Michael Gao, founder of Chinese e-cigarette company Moti. “The old box-style models, you could sell for $100,” compared to about $30 for a Juul-like device, Gao said. “So everyone had doubts about the pod model.”  Juul’s success quelled those doubts. Dozens of Chinese startups released pod-style vapes starting in 2018. Many had roots in China’s technology industry. Shenzhen-based Laan, for instance, was founded by former employees at WeChat, the messaging app owned by Tencent. YOOZ, based in Beijing, was launched by Cai Yuedong, an online media entrepreneur. Samuel Liu, who launched the Evove brand of e-cigarettes, envisions a mass market. “It’s a legal drug; it’s a fast-moving consumer good; and it’s an electronic product,” he said. “Electronic cigarettes will be the second item you carry in your pocket, after your phone.”   And yet Liu and others acknowledge the risk posed by China Tobacco. “When VC’s come to me, I always tell them they shouldn’t get too excited,” he said. “You don’t know when the government will come in and just claim this market for itself.”  Some VCs are embracing the risk. In April, RELX closed on $75 million in venture capital funding from high-profile investors including Sequoia China and Yuri Milner. In addition to e-commerce sites, RELX sells its products through bars, cafes and smartphone repair shops, and says it has more than 900 branded storefronts as franchise partners. The company also plans to soon open flagship stores in Southeast Asia and London. The company’s most popular flavors are mung bean, a common ingredient in Chinese desserts, and laobinggun, a type of popsicle popular in the nineties in China. “We search for flavors that are pretty familiar to people over 30, things that are old-fashioned and inspire emotion,” says Wang. China Tobacco dominates the nation’s tobacco supply from manufacturing to retailing. The same entity controls regulation under a different name – the State Tobacco Monopoly Administration. The administration has at times worked against efforts to limit smoking. In Hangzhou, for example, the local government in 2018 attempted to ban indoor public smoking. The movement lost momentum after the tobacco administration pushed for lighter measures including more designated smoking areas, which it said allowed for “civilized smoking” in a statement to Reuters at the time. In May 2017, the regulator claimed jurisdiction over heat-not-burn smoking devices - an alternative type of e-cigarette that creates a vapor from raw tobacco leaves. The decision effectively barred Phillip Morris International Inc from Chinese sales of its IQOS device, a heat-not-burn e-cigarette popular in Japan. China Tobacco subsidiaries have since begun testing their own heat-not-burn devices and selling them in limited quantities. Phillip Morris said in a statement it had no current plans to sell IQOS in China but did not comment on the nation’s regulation of the heat-not-burn sector. The government has sent conflicting messages on whether it intends to regulate e-cigarettes that vaporize liquid nicotine blends - or sell them itself. In March, state broadcaster CCTV aired a segment highlighting the potential health risks from inhaling nicotine and other chemicals in e-cigarette liquids. The spot was part of a program - broadcast annually on China’s national “Consumer Day” - that targets industries the government alleges have wronged the public. Industry players say they struggled to interpret the government’s message in the segment. They hoped it signaled that the tobacco monopoly would continue allowing e-cigarette sales but start regulating their quality and safety. They had the same hopes in May, when a government regulator submitted draft regulations for exported Chinese e-cigarettes to the World Trade Organization. Many industry observers, however, continue to believe China Tobacco will eventually enter the e-cigarette market itself. State-owned enterprises such as China Tobacco are “bloated and slow to take action,” said Maggie Chen of ESun, a Shenzhen-based consulting firm that helps companies comply with import and export regulations. “But they are definitely paying attention to this sector.”


Wyoming residents concerned about proposed horse facility.

Explanation: A wild horse facility is looking to make its home in eastern Laramie County, but residents near the proposed site have some major concerns.

Horses, Water quality, Animals, General News, Wyoming, Land management, Environment, Cheyenne

The facility would hold wild horses captured by the Bureau of Land Management, and the BLM would pay South Dakota-based Equine Elite an amount for each horse it houses. But the project hit a snag when it came to gaining approval from neighbors within a 3-mile (4.8-kilometer) radius. Due to concerns ranging from water quality to increased traffic, the neighbors didn’t give their approval for the project. Right now in Laramie County, any Concentrated Animal Feeding Operation needs the consent of property owners within 3 miles of the proposed site of the CAFO. At the request of Equine Elite, the Laramie County Commission is considering lowering the distance to 1 mile (1.6 kilometer). While the Wyoming Department of Environmental Quality only requires approval from property owners within one mile, the county commissioners changed its rules to 3 miles years ago when a swine CAFO attempted to situate in Laramie County. Ron Butler owns one of the properties closest to the proposed wild horse facility. If the commissioners ultimately decide to lower the distance to 1 mile, Butler’s approval might not be required, depending on where Equine Elite builds the stables. “This takes away pre-existing protections from landowners by changing the rules,” Butler told the Wyoming Tribune Eagle. The public notice and review process for the statute change will begin Tuesday. “There’s still a lot of things that have to happen before it comes before the commissioners,” County Commission Chairwoman Linda Heath said. Heath said the public hearings will give residents a chance to voice their opinions and share their viewpoints with the commissioners before they make a final decision. Though the plan is in its beginning phases, residents within the original three-mile radius are not fond of the proposed facility or changes to the Laramie County statute. Resident Bob Tierney said he has concerns about water supply and contaminated runoff. “They adopted the three-mile radius for a reason,” Tierney said. CAFOs are often utilized in the farming industry because they allow for specialization and large production operations. Perhaps the biggest issue with CAFOs, however, is the amount of waste they produce. According to a report from the U.S. Centers for Disease Control and Prevention, a facility can produce between 2,800 tons and 1.6 million tons a year, depending on the number of animals. “If it was going to be stinking in their backyards, they wouldn’t like it, either,” Tierney said. Waste from CAFOs is often used as fertilizer or kept in storage or containment units. The CDC’s report said these practices can affect groundwater and surface water by runoff or leaks from the containment units. Dale Sandberg now owns the property he grew up on, which is within the three-mile radius. He has another concern about the facility: Where will the water for the horses come from? “It is going to increase the water supply need,” Sandberg said. Tierney raised the same issue, saying it would leave less water for people down the line. Another problem the project might cause is increased traffic in the area. Sandberg said there’s already a decent amount of road activity from the oil production, and this could bring even more. He is against the change, but also noted that the commissioners shouldn’t alter any rule for an existing proposal. With all that’s up in the air, Butler said it’s important for the residents to have their voices heard. He started an online petition to bring before the county commissioners. “I think it compromises their quality of life,” Butler said. “It compromises the value of their properties. It compromises their water quality. It’s a myriad of problems.” ___ Information from: Wyoming Tribune Eagle, http://www.wyomingnews.com


In Chilean desert, global thirst for lithium is fueling a 'water war'.

Explanation: On Chilean water regulator Oscar Cristi’s desk, a small white espresso cup teeters atop piles of documents and loose folders that appear on the point of collapse, perhaps an apt metaphor for the growing water crisis in parts of the Andean country.

Sitting in his eighth-floor office adjacent to the presidential palace, Cristi, a PhD economist, lays out a map of Chile showing key watersheds for mining. Swaths of the mineral-rich north are colored blue, denoting areas where aquifers are over-exploited. Soon, if Cristi gets his way, they will be red, meaning new water rights will be banned. Reams of water rights were granted by Chilean governments over decades with little consideration for their cumulative impact as miners scrambled to stake claims on the small pockets of water available in the salt flats of the Salar de Atacama. The Salar sits in the world’s driest desert. The water trapped beneath the salt pan feeds the world’s biggest copper mine and holds in suspension more than one-third of the world’s current supply of lithium, the ultra-light metal used in electric car batteries, mobile phones and lap-tops. With demand for water growing in a region economically vital to the country, Cristi is now taking steps to rein in usage. But there is a problem. No one really knows how much water is there. Cristi said Chilean development agency Corfo, which helps oversee lithium extraction in the Salar, hopes to provide a better picture in a study due in December. “The state has been very reluctant to draw up bans on water extraction,” said Cristi, who was only recently appointed head of the water authority. “We want to take much more diligent approach in decreeing prohibited areas.”  Cristi did not say why past governments had been hesitant to declare bans. In Chile, threats of a government crackdown on over-usage of water often ring hollow. Mines need water, and the country´s copper-driven economy needs mines. A sweeping overhaul of Chile’s dictatorship-era water code proposed in 2014 has languished in Congress, slowed by intense lobbying by industry. Now though, the mining industry is paying close attention to  Cristi. Earlier this month his agency imposed a rare ban on new permits to extract water from an aquifer that is a critical water supply for BHP´s Escondida, the world´s largest copper mine. The agency is also preparing to create a drinking water reserve nearer the operations of top lithium producers SQM and Albemarle that would allow the government to further restrict water use there. SQM and Albemarle say they have all the water rights they need and do not expect new restrictions to impact their current or future production of lithium. A global boom in demand for lithium has set off a scramble in Chile, which is home to nearly 50 percent of the world’s reserves of the metal. Local indigenous groups, SQM and Albemarle, regional copper miners and newcomers to the region are all competing for water. “What we have is a water war in the salt pan. There’s a huge crush on water and nowhere to get it from,” said Alonso Barros, an attorney with the Atacama Desert Foundation, an NGO that works with indigenous groups in the region. SQM and Albemarle both recently signed deals with the government to sharply increase their quotas for extracting lithium from the Salar, although they say they will not use any more water than they have already been granted. Newcomers like Wealth Minerals, New Energy Metals, and Lithium Chile have also announced projects in the salt flats. Wealth Minerals, New Energy Metals and Lithium Chile did not immediately respond to requests for comment. On a computer screen, Cristi scrolls through a spreadsheet showing row upon row of water rights granted decades ago in the southernmost sector of the Salar - totaling six times more than the government now believes available - with little more than each company’s own data to support their sustainability. Past governments did not adequately map how much water is available, says Cristi. Now monitoring wells are being installed in some areas, but base line data is still lacking. “Our (understanding) continues to be limited now, but back then, it was very limited,” he said. The cumulative impact of water rights granted over the years to copper and lithium miners in the world’s most arid desert has never been considered, according to Ingrid Garces, a professor who studies salt flats at Chile’s University of Antofagasta. “We’re managing lithium as though it were a type of hard-rock mining,” said Garces. “But we’re mining water, not rock. This is a watershed.”   Take too much water from one place, she says, and it may impact another, comparing it to sucking water from a glass with a syringe. “Even if you’re drawing from just one area, the whole is still reduced,” she said. Sorting out the water crisis at Atacama is complicated by a lack of data, but also a jurisdiction issue. The brine from which miners extract lithium is water, but in Chile, it is regulated as a mineral like copper or iron. Environmental regulators handle permits for brine, while the water authority permits freshwater pumping. A lack of communication between the two, combined with a lack of understanding about how freshwater and brine interact beneath the Salar, has left authorities hamstrung, says Cristi. “There may be an imbalance that we’re not accounting for,” he said. (Refiles to add dropped word “to” in paragraph two)


In Nagoya, scramble for hospital beds shows coronavirus challenge for aging Japan.

Explanation: Hospitals in Nagoya city in Japan’s industrial heartland have more coronavirus patients than they can treat, forcing transfers to nearby areas and offering a glimpse of the challenges the outbreak poses for a country with a huge elderly population.

Japan has closed schools and canceled public events, which experts say has helped prevent an explosive spread of the virus. But because testing hasn’t been widespread, some medical experts say the extent of infection is understated, and a surge could yet happen. That would put more of the country under the strain now being felt in Nagoya, and force a nationwide scramble to shift patients, many of them elderly, to hospitals in areas with capacity. “If the numbers rise further, we won’t be able to cope, so we will either have to ask nearby prefectures to help, or tell those with lighter symptoms to stay at home,” a prefecture  official in Nagoya told Reuters. Confirmed coronavirus cases in Nagoya, the capital of Aichi prefecture, totaled 98 as of Sunday, the official said, far exceeding the city’s 27 beds at hospitals that meet conditions for patients with the highly contagious disease. Aichi, home to Toyota Motor Corp (7203.T), is Japan’s second-hardest hit prefecture, with 121 confirmed coronavirus cases so far. It has a total of 161 beds capable of handling patients with such a disease. Of those, 105 were in use as of Sunday, the official said. Elderly people are especially vulnerable to serious effects the virus. Japan has the world’s oldest population, with more than 28% aged 65 or over. Italy, which has Europe’s oldest population, is facing growing concerns about the ability of its strained health system to cope with a relentless increase in new cases. “If we allow the epidemic to continue, it’s a matter of time,” said Hokkaido University professor Hiroshi Nishiura when asked if Japan could face a situation similar to Italy’s. He added that the trajectory of the epidemic was hard to predict. Japan has been hospitalizing all patients who test positive for the virus, even if symptoms are slight, in line with its law on infectious diseases. But now, in some areas, patients with lighter symptoms are being asked to isolate at home. To free up more hospital beds, patients with non-urgent surgery will likely be asked to wait, and others may be discharged earlier than is usual in Japan, experts said. Hospitals are being asked to prepare plans for transferring patients to places that can treat them, given how the speed of the spread has varied by region, said Takuma Kato, a health ministry official. Japan’s health ministry has issued guidelines on handling an influx of coronavirus patients based on estimates of what peak numbers might look like. “Potentially, there will be a surge of new cases if Japan is not successful in containment, which I think will happen,” said  Kenji Shibuya, director of the Institute of Population Health, King’s College, London. “Japan is not yet at the level of what Italy is experiencing in terms of outbreak phase, but that gives us a very important lesson - we have to be prepared,” he said. The death toll in Italy rose to 1,809 by Sunday after a 25% jump in just 24 hours. The number of cases hit 24,747. Prime Minister Shinzo Abe has said there were 12,000 beds nationwide that could take serious virus cases and 3,000 respirators, but Shibuya said that didn’t mean there were trained medical staff to handle all of those cases. A national action plan based on a 2012 law calls for hospitalizing severe cases and treating mild cases at home. Parliament on Friday revised that law to allow the government to declare a state of emergency to cover the coronavirus. Abe has said conditions didn’t warrant such a declaration yet. A shortage of cutting-edge equipment to treat the most severe cases also poses a risk, and could force tough decisions about whom to treat if cases rise fast, as in Italy. For example, a ventilator might be in use for a 90-year-old patient while a seriously ill 30-year-old nurse went without,  said Koji Wada, a member of the government advisory panel. “So we need to discuss the ethical issues too,” Wada said.


Explanation: The article focused on a recent systematic review of the effectiveness of spinal manipulation for chronic low back pain. The Cochrane Collaboration review found that this popular treatment leads to rapid short-term pain relief and improvement in function. But the magnitude of the treatment effect was modest at best. And manipulation did not provide a “clinically significant” advantage over other common treatments for chronic low back pain, according to this review. The HealthDay article made a key observation about chronic back pain: that there is no “silver bullet” for it. And it provided a brief but fair description of the systematic review and the evidence it considered. Our reviewers could have gone either way on several of the graded criteria, so the 4-star final score may be a bit deceiving. What were some of the shortcomings of this article? The article had a misleading title: “Study Questions Chiropractic’s Impact on Back Pain”. This systematic review looked at the effects of manipulation as practiced by multiple professions rather than the impact of chiropractic per se. Since the review concluded that manipulation is a viable treatment for chronic back pain, one can argue that it supports rather than questions this manual therapy. It might have been useful to ask an impartial expert how the new review on manipulation compares with other recent reviews of the evidence in this area. And how manipulation compares with other effective treatments for chronic back pain. Readers of this article might well have come away with the impression that all treatments for chronic back pain offer similar results. This is not the case. Of the 200 or so therapies for chronic back pain in the medical marketplace, no treatment consistently offers a major benefit. Only a few have been proven to provide a moderate benefit for chronic back pain. The most influential U.S. guideline found only six treatments, including manipulation, where there was “good” evidence of a “moderate benefit” for chronic back pain (See Chou et al., 2007; Chou et al., 2009). An influential British review concluded that three general approaches (exercise, manual therapy including manipulation, and acupuncture) provide roughly equal benefit in the early management of persistent back pain. (See NICE, 2009). So the new review on manipulation is reasonably consistent with the larger evidence picture. It would have been useful if the article could have highlighted this point—since it offers an important message for people with chronic back pain. Based on this body of evidence, they shouldn’t be expecting heroic cures. Rather, they should look for validated treatments that can help them stay comfortable and active—and that align with their values, expectations and tolerance for risk. References: Chou R et al., Diagnosis and treatment of low back pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society,  Annals of Internal Medicine, 2007; 147:478-491. Chou R et al., Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain, Spine, 2009; 34(10): 1066-67. NICE, Early management of persistent non-specific low back pain; 2009; see http://www.nice.org.uk/nicemedia/pdf/CG88NICEGuideline.pdf                                      Spinal manipulation is one of the most popular treatments for low back pain in the United States and many other nations. The 2007 National Health Interview Survey concluded that roughly 8.6% of U.S. adults—close to 20 million individuals—utilized chiropractic or osteopathic manipulation. Despite its popularity, spinal manipulation is still commonly referred to as a “complementary/alternative” therapy rather than a mainstream treatment. Though it enjoys considerable support in systematic reviews and guidelines, spinal manipulation remains somewhat controversial and is not widely available in primary care medical settings. It does not enjoy completely consistent support from insurance companies. So determining the optimal role of manipulation in the management of chronic low back pain—in both chiropractic and conventional medical settings— is an important priority.

The article did attempt to offer information on the costs of manipulation by consulting a spokesman for the American Chiropractic Association. However, the article only offered the unsatisfactory observation that costs vary. The journalist could have dug deeper and documented the range of costs per manipulation treatment—and the typical number of visits per back pain episode. The costs and cost-effectiveness of manipulation are important issues. If multiple treatments for chronic back pain provide similar benefit, then the value of the treatment modality is really dependent on the cost. The article offered only broad characterizations about the treatment effects of spinal manipulation for chronic low back pain. It did not attempt to quantify the treatment effects in terms of pain relief or functional improvement. However, the systematic review that served as the focus of the article is complex and somewhat difficult to decipher, with outcomes including pain and function at different time points. And the story did provide the reader with a reasonable summary. Manipulation appears as good or bad as other treatment options—and it may lead to more rapid pain relief. Any review of a treatment should discuss both the benefits and risks of the treatment. The story focused entirely on the comparative effectiveness of manipulation, and ignored discussion of potential harms and adverse effects. Many people are scared away from spinal manipulation for low back pain over the potential risk of serious complications such as cauda equina syndrome, paralysis, and death—or the exacerbation of a disc herniation. However, as the new systematic review pointed out, serious complications related to manipulation for low back pain are extremely rare. The article provided the reader with an adequate amount of information about the study design and the inherent difficulties in interpretation of existing studies. There was no evidence of disease mongering in this article. This article was refreshingly free of the overheated rhetoric about the “agonies” of chronic low back pain—and the need for novel treatment breakthroughs— that often permeate media features. Instead it took a sober, matter-of-fact approach. The article did include expert commentary by a spokesman for the American Chiropractic Association. He offered reasonable and interesting comments. However, one could argue that a spokesman for a professional organization that is heavily involved in the provision of spinal manipulation is not a truly independent and impartial source. That spokesman might be viewed as having a conflict-of-interest in offering commentary on this topic. So it would have been useful for the article to include the views of another expert commentator as well. The article did provide information on how spinal manipulation stacked up against other treatments for back pain, as reported in the systematic review. However, it did not discuss the larger body of evidence on treatments for chronic low back pain—or what other reviews and guidelines have concluded about the role of spinal manipulation in its management. We’ll give the story the benefit of the doubt on this criterion. The article gets a “satisfactory” because it pointed out that manipulation is commonly performed by multiple healthcare professions. It would have been useful to mention that manipulation is not routinely available in conventional primary care medical settings. And despite its evidence record, it does not generally enjoy completely consistent insurance coverage. The same points apply to massage. Manipulation is an age-old treatment. There was no reason for the article to discuss its novelty. The article did not appear to rely on a news release.


Fertility supplements may help some women conceive

Explanation: Getting pregnant is harder than most women realize, but that doesn’t mean that if it takes time, there is something wrong that must be treated or dealt with. Furthermore, conception is a serendipitous process that isn’t fully under our control, although you wouldn’t know that from the myriad of products available. In the US, fertility treatment is a big business. This story describes one type of supplement for fertility support that includes a wide variety of ingredients. The story quotes many of the claims made on the company’s website but injects some amount of healthy skepticism. This relatively short story includes valuable information, such as the availability and cost of the supplements. It provides details on one study evaluating the supplement but could have commented on whether these results have been validated by other studies. It quantifies the results of that one study but is careful not to make claims that the supplements improve fertility by X or Y%, which is appropriate given how small the study was. The story quotes more than one expert, one who works for the company and one who does not. This independent source is crucial in this story and provides much-needed perspective. The story could have been improved by describing alternative options, other than to "see a doctor". For example, monitoring ovulation, quitting smoking and drinking, maintaining a healthy weight and managing stress and depression may help. Furthermore, the story does not mention any harms of the supplement, known or unknown. Even if the harms are not known, the story should have highlighted that. Side effects of chasteberry, an active ingredient in the supplements, can include nausea, headaches, GI disturbances, and menstrual cycle irregularities.

The story clearly states the cost of the supplements. The story quantifies the results of the one small study but is careful not to make claims that the supplements improve fertility by X or Y% The story does not mention any harms of the supplement, known or unknown. Even if the harms are not known, the story should have highlighted that. Side effects of chasteberry can include nausea, headaches, GI disturbances, and menstrual cycle irregularities. The story provides details on one study using the supplement. The story could have commented on whether these results have been validated by other studies. The story rightly points out that conception is a "mysterious business" in that it is not fully understood nor do we have control over it. Most women take a while to get pregnant, even up to a year is not considered abnormal. However, the story could do women who are worried about this more of a service by reminding them that variation in time to conceive is normal and they should not run out and get supplements right away. The story quotes more than one expert, one who was involved with the study and one who was not. The independent source is crucial in this story. The story does not describe alternative options, other than to "see a doctor". For example, monitoring ovulation, quitting smoking and drinking, maintaining a healthy weight and managing stress and depression may help. The story clearly states that the supplements are available on the company website, though it isn’t clear whether they are available elsewhere. Clearly supplements for fertility are not a new idea. The fact that an independent source has a key voice in the story shows that it did not rely solely on a news release.


Study finds early potential in GSK leukaemia drug

Explanation: There are no independent experts quoted. This is not sound journalistic practice, turning the platform over to conflicted sources with no evidence of any critical analysis or independent vetting of claims. The treatment of childhood leukemias has improved considerably in the past several decades. Despite the improvements however, some childhood forms remain difficult. A story about a potential new treatment option is important but it must be presented in a way that does not provide inflated claims and false hope to parents.

Given the extremely early stage of research, we can understand why cost was not discussed. Inadequate explanation. See “evidence” criterion above. While the story does provide several qualifications, it fails to place this very early research into perspective. Given the tortuous road to a drug’s demonstration of effectiveness and eventual approval any suggestion of patient benefit (such as “early potential…could treat…could halt the disease”) is excessive. If a news story can speculate about “early potential” benefits in a headline from such early laboratory results, it can also speculate about potential harms from the pathway this proposed intervention takes. What could go wrong with this approach? What will scientists be concerned about as they move into clinical trials? The story talks only about potential benefits. There are always potential harms on the horizon. There was no critical journalistic analysis of the evidence. In fact, we’re never told exactly how well the experimntal approach worked in the mice and cancer cells tested in the lab – only that “the chemical could halt the disease.”  That simply doesn’t tell readers – investors or patients – anything useful about how it performed. Did it work in each experiment attempted? Half the time? Ten percent of the time? Equally well in the mice and in the human cancer cells? What differences in response? The story suggests (as did the news release upon which it was based) that up to 80% of leukemia cases in patients under the age of 2 years involve the MLL fusion protein. Important as this is, it is a bit misleading to the average reader. According to the National Cancer Institute


Former Winona candy factory to become pet vitamin plant.

Explanation: A former candy factory in Winona soon will be producing gummi and gel supplements for pets.

Health, Winona, Pet health, Business, Pets

Midwest Co-Pack purchased the former Ferrara Candy Company building to use as the primary supplier of The Pet Health People. The company is hoping to use the space to make gummi vitamins for dogs, among other products. Amy Paris, CEO of Midwest Co-Pack and The Pet Health People, said in a statement that the companies will work to grow upon previous success. “My desire to vertically align (Pet Health People’s) supply chain, from production to fulfillment, has been our goal since inception, but it was important to find the right fit for our business,” Paris said. “The expertise of the staff at Midwest Co-Pack is unparalleled; I have no doubt that their input will not only support my already established business, but ensure that it continues to thrive.” The company is aiming to hire more than 10 people to start. Officials said they hope to rehire former candy factory employees. The Ferrara facility closed in spring 2016. Winona Mayor Mark Peterson said the city is lucky to have someone take over the building in a relatively short time. “All expectations are that this will be a growing company,” Peterson said. Company officials said they hope to produce tens of thousands of pounds of finished goods daily by adding new machinery, growing the company and using former plant employees, who have an average tenure of 25 years in food manufacturing. The plant was built in 1940 and operated as a candy factory for several companies before closing.


Cabin crew swap aircraft aisles for hospitals in UK's coronavirus fight.

Explanation: Britain’s temporary hospitals are seeking volunteers from airlines, calling on cabin crew members who are currently grounded to use their first-aid skills and calm manner to help get the new Nightingale hospitals up and running.

Ashley Brown, 23, will soon swap easyJet’s orange-trimmed gray suit and waistcoat for the blue plastic overalls of personal protective equipment after he signed up to help the National Health Service (NHS) fight coronavirus. His first aid training and security clearance mean he is a desirable recruit for the new hospitals, as does his experience working in what can be a high-stress environment. “When you’re at 38,000 feet in the air and something does go wrong, which isn’t often, but obviously, medically, things do go wrong, you have to think on your feet,” said Brown. Britain is building three new hospitals in London, Birmingham and Manchester, which it is naming after nursing pioneer Florence Nightingale, to cope with an expected surge in coronavirus patients, but it needs back-up staff. EasyJet has written to 9,000 staff, and Virgin Atlantic to around 4,000, to ask them to consider volunteering at a time when they cannot do their day jobs because air travel has come to a standstill. EasyJet said on Monday it had parked up all its 344 planes and laid off UK-based cabin crew for two months, meaning they will not work from April 1, but will get 80% of their average pay under a state job-retention scheme. The NHS said volunteers would receive training and help doctors and nurses with changing beds and other non-clinical tasks. Brown, who formerly worked for an NHS Trust in its stop-smoking services, says he loves the cabin crew job he’s been doing for the past three years and is realistic about the pay cut he faces over the coming months. “It is what it is, at the end of the day. I want to keep flying, I want to keep my job, the same as everybody else, so we’re all more than happy to support our airline to get to where we need to be to return to flying,” he said. Asked about the risk of potentially being exposed to the virus by going into the new hospitals, he says the worry will be there in the back of his mind, but that’s no different from his day job. “The job I do, I have to think about safety every single day,” he said.


Utah banning ‘conversion therapy’ with Mormon church backing.

Explanation: Utah is on its way to becoming the 19th state to ban the discredited practice of conversion therapy in January after state officials formed a proposal that has the support of the influential Church of a Jesus Christ of Latter-day Saints.

Religion, Health, General News, Utah, Science, U.S. News, Gary Herbert

Republican Gov. Gary Herbert announced Tuesday night that church leaders back a regulatory rule his office helped craft after legislative efforts for a ban on the therapy failed earlier this year. The faith known widely as the Mormon church opposed a previous version of the rule because it wanted assurances that church leaders and members who are therapists would be allowed to provide spiritual counseling for parishioners or families — which were included in the latest conversion therapy ban plan. The faith opposes gay marriage and teaches that intimidate same-sex relationships are a sin. The religion has stuck to that belief while urging members to be kind and compassionate to LGBTQ people. Conversion therapy is a practice used to try to change peoples’ sexual orientation or gender identity. The rule would ban Utah therapists from subjecting LGBTQ minors to the practice that the American Psychological Association has said is not based in science and is harmful to mental health. The Utah rule proposal is set to go to a 30-day public comment period beginning Dec. 15 and take effect as soon as Jan. 22, Herbert said. The success in getting the church’s crucial support for the regulatory rule generated praise from LGBTQ advocates and conversion therapy survivors who had expressed frustration with the yearslong battle in Utah to ban conversion therapy. The rule uses language from a state legislative proposal that failed this year despite church leaders saying they would not oppose it. “It means youth will be getting adequate services that will help them rather than harm them,” said Nathan Dalley, 20, who had conversion therapy when he was 16. “This is a change that’s been needed for so long. It’s too late, but I’m happy it is here.” Dalley grew up as a member of the Latter-day Saint faith and said he was told during his therapy to snap a rubber band on his wrist every time he felt attracted to men. His therapist also scrutinized his posture, his walk, his gestures and interests. Dalley said the experience deepened his feelings of depression and culminated in a suicide attempt several months after the therapy. Church government affairs director Marty Stephens reiterated in the governor’s news release that the faith denounces conversion therapy and wants a ban. He said in an interview with The Associated Press last month that the faith doesn’t ascribe to “pray the gay away” thinking but that prayer and religious teachings can be helpful to people trying to navigate life’s challenges. The religion holds tremendous influence in Utah, where the majority of state lawmakers and nearly two-thirds of the state’s 3.1 million residents are members of the faith. Herbert is a member and so are all six members of the state’s congressional delegation, including U.S. Sen. Mitt Romney. The church had said in an Oct. 15 letter to state regulators that it would support a “carefully tailored” rule to ban “abusive” practices like conversion therapy but contended an earlier regulatory proposal banning the practice defined sexual orientation and efforts to change sexual orientation so broadly that it “would imperil legitimate and helpful therapies to the detriment of minor clients.” For example, the church had claimed the bill would have prohibited therapists from discussing strategies for avoiding same-sex intimacy when young people seek help to adhere to the faith’s teachings. The revised rule stipulates that the ban doesn’t apply to clergy members or religious counselors acting in a religious capacity, or to a parents or grandparents who happen to be a mental health therapist if they are talking to children or grandchildren. Justin Utley, 42, who attempted suicide more than a decade ago after going through conversion therapy, said he’s concerned about the exceptions granted to the church even but said the new rule is a positive step. “Progress is progress in this state. You kind of have to make some compromises,” Utley said. “My concern, though, is clergy who are licensed professionals having this ability to justify conversion therapy by claiming that they’ve turned off the switch and now are acting as a clergy member instead of a licensed professional. That’s a very dangerous precedent.” During a public hearing about the rule in September, Utley and other supporters of a conversion therapy ban said enduring the therapy led to shame, depression and suicide attempts. Opponents argued that the rule would prevent parents from getting help for children with “unwanted” gay feelings or even from talking about sexuality with their kids. Herbert said “the stories of youth who have endured these so-called therapies are heart rending.” He added: “I’m grateful that we have found a way forward that will ban conversion therapy forever in our state.”


Health care worker in Grant County has mumps.

Explanation: The Grant County Health District has issued an alert about a confirmed case of mumps in a Grant County resident.

The health district says a vaccinated health care worker has been confirmed with the mumps. KXLY-TV of Spokane reports the worker developed symptoms on December 2, which means their contagious period was from November 30 through December 7. During that period, the worker was at two Moses Lake health care facilities, Samaritan Healthcare, and Confluence Health. The health district is working with each facility to identify all staff and patrons who could have been in contact with the individual. ___ Information from: KXLY-TV, http://www.kxly.com/


India cyclone kills at least 33, hundreds of thousands homeless.

Explanation: Hundreds of thousands of people were left homeless after a cyclone packing winds of about 200 km per hour slammed into eastern India, ripping out tin roofs and destroying power and telecom lines, officials said on Sunday.

At least 33 people were killed after cyclone Fani struck the state of Odisha on Friday but a million people emerged unscathed after they moved into storm shelter ahead of landfall. The death toll could have been much greater if not for the massive evacuation in the days before the storm made landfall, officials said. The seaside temple town of Puri, which lay directly in the path of Fani, suffered extensive damage as winds gusting up to 200 kph (124 mph) tore off tin roofs, snapped power lines, and uprooted trees on Friday. “The cyclone has killed 21 people in Puri and about 300 people are injured,” Brajabandhu Dash, medical officer at Puri, told Reuters. Earlier, 12 deaths were reported from other parts of the state. The depression over the Western Meghalaya and adjoining Bangladesh has weakened, and will become insignificant in the next 24 hours, India’s met department said on Twitter early on Sunday. According to preliminary reports, Fani damaged power infrastructure worth more than 12 billion rupees ($173.7 million) and the authorities are trying to restore electricity supply for emergency services, another official said. More than 60,000 people including officials and volunteers were involved in relief operations, said special relief commissioner Bishnupada Sethi, who monitored the evacuation. The relief effort used sirens, loudspeakers and sent more than 20 million mobile messages to the targeted people, he said. The cyclone season in the Bay of Bengal can last from April to December, and storms can be deadly. In 1999, a super-cyclone battered the coast of Odisha for 30 hours, killing 10,000 people. Fani was the strongest summer cyclone in 43 years to hit Odisha, disrupting water supplies and transport links, the state’s chief minister Naveen Patnaik said in a statement. “We are in the process of restoring physical infrastructure,” he told reporters. Relief agencies were trying to provide food and medicine to victims in other parts of the state, while hundreds of thousands were still not accessible due to roadblocks and disruption in the communication network, officials said. The town of Puri was littered with tree branches, the debris of damaged houses and broken glass. Relief teams were trying to clear the roads. “There was no wind at night (before landfall). We thought nothing will happen,” P. Chittmma, 45, told Reuters while laying on a bed at a government hospital, showing her fractured leg.


Blue Buffalo pet food contains unsafe and higher-than-average levels of lead.

Explanation: Aside from a single claimant’s lawsuit against Blue Buffalo and an unrelated recall on one variety of Blue Buffalo product in March 2017, we found no credible information suggesting that Blue Buffalo dog food was tested and found to have abnormally high levels of lead.

In June 2017, a rumor appeared that Blue Buffalo brand pet food had been recalled because it contained toxic levels of lead: I have seen claims that Blue Buffalo brand dog food contains unhealthy amounts of lead. It is a highly regarded brand of dog food, Can you confirm if this rumor is true? As is often the case with pet safety claims, the rumor spread via word-of-mouth, periodically reappearing on social media. According to various versions of the rumor, all Blue Buffalo dog and cat food had been recalled because of the presence of lead, and a class action lawsuit had been filed after the brand was caught tainting its food: Blue got caught putting lead in their food and killing thousands of dogs. Do your research please before buying a product. — Logan (@LoLoR_2412) January 4, 2018  However, we found only one legitimate recall involving Blue Buffalo brand, which had nothing to do with lead content and affected just one particular variety. It’s possible that the date of the issued recall (17 March 2017) led to the story resurfacing after a year, creating some confusion: Blue Buffalo Company is voluntarily recalling one production lot of BLUE Wilderness® Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs, as the product has the potential to contain elevated levels of naturally-occurring beef thyroid hormones. Dogs ingesting high levels of beef thyroid hormones may exhibit symptoms such as increased thirst and urination, weight loss, increased heart rate and restlessness. These symptoms may resolve when the use of the impacted food is discontinued. However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing. Should these symptoms occur, contact your veterinarian immediately. Although the Blue Buffalo Customer Care Resource Team has not received any reports of dogs exhibiting these symptoms from consuming this product, the FDA advised Blue Buffalo of a single consumer who reported symptoms in one dog, who has now fully recovered. Blue Buffalo immediately began an investigation, however, and after working with the FDA, Blue Buffalo decided it would be prudent to recall the one production lot in question. The claims upon which the lead rumors were based came from a lawsuit [PDF] filed by one individual in California, who claimed to have “independently tested” varieties of Blue Buffalo dog food after the death of a pet: Plaintiff’s independent lab testing of the Contaminated Dog Foods found that Blue Wilderness Chicken Recipe for Small Breed Adult Dogs contains 200 ppb of lead; Blue Freedom Grain-Free Chicken Recipe for Small Breed Adult Dogs contains 140 ppb of lead; and Blue Basics Grain-Free Turkey & Potato Recipe for Adult Dogs contains a staggering 840 ppb of lead. In response to the March 2018 viral warning, Blue Buffalo issued a statement via Facebook “to set the record straight about these baseless allegations,” asserting that their pet food products were safe:


2020 hopeful Moulton shares mental health woes as war vet.

Explanation: Democratic presidential candidate Seth Moulton is highlighting his plan to improve mental health care in the United States, particularly for veterans, by revealing his own struggles with post-traumatic stress.

Lynn, Mental health, Health, Politics, Seth Moulton, Election 2020, Massachusetts, North America, Veterans, United States

Moulton, a Massachusetts congressman and Iraq War veteran, said Tuesday at a town hall in Lynn that he started seeing a therapist after returning home from the war. He said one memory that has stayed with him is driving past an injured Iraqi boy lying in the middle of the road without stopping to help him. He said stopping to take care of the child would have endangered the lives of his entire platoon. The image of that boy, he said, is “something that haunted me every single day when I came home. Frankly, every single day that I was there.” Moulton said he can’t put into words how much therapy has helped him. “I’ll be haunted by the image of that boy until the day that I die. But now I control what I think of,” he said. “I don’t think about it every single day. I can choose moments like this to bring it up.” Moulton’s mental health plan would require annual mental health checkups for active-duty military and veterans, fund yearly mental health screenings for every high school student and establish a national mental health crisis hotline. Moulton said he would also double the number of Defense Department mental health professionals and boost the mental health budget by $500 million. “Even as we recognize and celebrate the talents and achievements of military veterans, we must also acknowledge that we have asked them to shoulder an enormous burden on our behalf,” he said in a written statement.


“Guess what, [children are] not at risk unless they have an underlying medical issue.”

Explanation: Pa. House Speaker Mike Turzai argued that children are largely protected from the ravages of the coronavirus because of their youth and would be safe if they return to school in the fall. A new study published in the medical journal JAMA Pediatrics found that roughly one in five children with serious cases of coronavirus had no underlying medical conditions. In New York City, 52 children sickened with the coronavirus have developed a serious condition called pediatric multi-symptom inflammatory syndrome.

National, Coronavirus, Pennsylvania, Mike Turzai,

Arguing that Pennsylvania should move quickly to reopen its economy even as coronavirus cases surge in some areas, the state House’s Republican leader said this weekend that reopening schools in the fall should be a top priority. Not only do students deserve a chance to perform experiments in science labs and play instruments in recitals, House Speaker Mike Turzai said children are largely protected from the ravages of the virus because of their youth and would be safe if they go back to school. "Guess what, they’re not at risk unless they have an underlying medical issue," said Turzai, whose comments came in a video he recorded from his Allegheny County home and later shared on social media. We wondered whether school-age children are as safe as the house speaker says. Turzai was on the right track when he said that children in poor health who contract the coronavirus are at risk of becoming seriously ill. And it’s true that children are far less susceptible than adults. But his claim that other children are totally safe is incorrect, according to a study published recently in the medical journal JAMA Pediatrics. Turzai declined to provide any evidence he relied on when he made this claim. Testifying before the Senate this week, Anthony Fauci, the government’s top infectious disease doctor, warned Americans not to be "cavalier in thinking that children are completely immune to the deleterious effects." The study followed 48 children and young adults with COVID-19 who were admitted to pediatric intensive care units in the U.S. and Canada in March and April. Roughly one out of every five children studied had no underlying conditions. The others suffered from immune suppression, obesity, diabetes, seizures, or chronic lung disease. In some cases, the impact of the virus was devastating. The Rutgers University researchers who authored the study found that more than 20% of children experienced failure of two or more organ systems and almost 40% required a breathing tube and ventilator. At the end of the study period, a third of the children the researchers tracked were still hospitalized. Two of the children had died. "Children without chronic illness are also at risk," the study authors wrote. "Parents need to continue to take the virus seriously." Publication of the study came the same day New York City officials announced that a growing cluster of children sickened with the coronavirus have developed a serious condition called pediatric multi-symptom inflammatory syndrome. So far, at least 52 children have been diagnosed with the syndrome, which causes high fever and swelling and may cause heart and kidney failure. Most are between the ages of 5 and 9. New York City officials said symptoms of the syndrome vary from patient to patient but include fever, rash, bright red lips, swollen hands and feet and abdominal pain. One five-year-old has died. "This was not something that the health care community saw on their radar," New York City Mayor Bill de Blasio said Tuesday at his daily coronavirus briefing. "Then in the last week or two, suddenly, we’re seeing something that’s very troubling." In other parts of New York state, 21 additional children with coronavirus symptoms have become seriously ill. It’s unclear whether any of the children sickened by pediatric multi-symptom inflammatory syndrome had underlying medical conditions. Half of the children in New York City who were diagnosed with the syndrome tested positive for COVID-19, meaning their bodies are battling an active infection and the syndrome simultaneously. Almost  two dozen other children with the syndrome tested positive for antibodies against the disease, meaning they had previously contracted the virus and recovered before they developed symptoms of the syndrome. It’s not known how many Pennsylvania children may have developed pediatric multi-symptom inflammatory syndrome. According to data from the state Department of Health, fewer than 3% of the almost 60,000 known coronavirus cases across the state are among children and teenagers. Speaking about the coronavirus, Turzai said children are "not at risk unless they have an underlying medical issue." A new study and a growing number of gravely ill children in New York City prove otherwise. We rate this statement .


H9N2 bird flu threat understated in humans says expert.

Explanation: The H9N2 bird flu strain, identified as a possible pandemic threat, could be infecting more humans than commonly thought but its mild symptoms mean it often goes undetected, a leading Hong Kong bird flu expert said.

Chickens are seen in cages at a poultry store in Hong Kong, June 11, 2008. REUTERS/Bobby Yip “It’s quite possible ... H9N2 is infecting humans quite a lot, much (more) than we appreciate merely because it is beyond the radar,” Malik Peiris, a Hong Kong-based microbiologist, told Reuters. “In humans, it is very mild, so most of the time it’s probably not even recognised or biologically tested,” said Peiris, who has co-authored several papers on the strain in recent years. So far, only a handful of human H9N2 cases have been documented worldwide, including four children in Hong Kong in 2003 who suffered from mild fevers and coughs — as well as a batch in China’s Guangdong province, where people often live in close proximity to poultry, Peiris said. The Hong Kong cases were only picked up by chance given the city’s rigorous influenza testing regime, Peiris said. “It’s quite a silent virus, it’s not highly pathogenic ... and sometimes it causes some morbidity in poultry but by and large it is just there and it’s unnoticed,” Peiris said of the H9N2 strain. The strain occurs mostly in birds, although it has also affected pigs and other animals in Europe and Asia. Most influenza experts agree that a pandemic — a deadly global epidemic — of some kind of flu is inevitable. No one can predict what kind but the chief suspect is the H5N1 bird flu virus, which has infected 385 people and killed 243 of them since 2003. However, flu experts at the University of Maryland, St. Jude’s Children’s Research hospital in Memphis and elsewhere recently wrote in the Public Library of Science journal PLoS ONE that the H9N2 strain posed a “significant threat for humans”. They found that just a few mutations could turn it into a virus that people catch and transmit easily. Peiris said that while the H9N2 strain might be more transmissible, its effects would be far less devastating than a possible H5N1 pandemic. “There are other viruses out there besides H5N1 that could be the next pandemic,” Peiris said. “But I suspect (H9N2) will not be so severe in its outcome.”   Peiris pointed out that the last three major pandemics vastly differed in their severity, with the 1918 Spanish flu pandemic killing an estimated 50 million people worldwide, whereas the “Hong Kong” flu in 1968 killed around one million. There are hundreds of strains of avian influenza virus but only four — H5N1, H7N3, H7N7, and H9N2 - are known to have caused human infections, according to the World Health Organization.


Explanation: Vince Foster’s death has not been ruled a homicide after autopsy, despite fake news reports

A fake news story saying former White House counsel Vince Foster’s body shows evidence that he didn’t die of a suicide is only part of a wide range of false Internet posts that won’t let rest the idea he was killed by Bill and Hillary Clinton. A March 24, 2017, story posted on Liberty-Courier.com carried the headline, "Breaking: Autopsy results from Vince Foster’s exhumed body — Cause of death to be changed!" The site, which is registered to an address in Utah, uses a name that evokes a newspaper, but is filled with fake news stories and has no immediately apparent contact information. The Foster story was flagged by Facebook users, who reported it as potentially being fake as part of the website’s efforts to push fabricated stories out of its news feeds. Foster, who was deputy counsel to President Bill Clinton and a former Arkansas law colleague of Hillary Clinton, committed suicide in 1993 at age 48, after suffering from depression. He was buried in his hometown of Hope, Ark. Conspiracy theories have raged for years that the Clintons actually had Foster killed for his knowledge of the Whitewater real estate deal or some other insight. President Donald Trump is among those who have questioned whether Foster actually committed suicide, despite five different investigations concluding he suffered a single, self-inflicted gunshot wound. The post, meanwhile, is fake, and has ended up on other fake news websites. It says that U.S. Rep. Trey Gowdy, R-S.C., had ordered Foster’s body exhumed. It cited a U.S. Navy officer as saying the forensics lab at the Naval Hospital in Norfolk, Va., determined Foster suffered two gunshot wounds, and his death should be reclassified as a homicide. Foster’s body has not been exhumed, and there is no Naval Hospital in Norfolk — although there is a Naval Medical Center across the Elizabeth River in Portsmouth, which used to be known as Naval Hospital Portsmouth. The post is accompanied by a photo that purports to be of naval forensics specialists, but actually is a handout photo from the Sacramento County (Calif.) Coroner’s Office. The story first appeared on March 22 on TheLastLineOfDefense.org, a site that has been the source of several fake news stories that we’ve previously checked. Their posts often end up being repurposed by many other websites that don’t credit its origin, as is the case here. TheLastLineOfDefense.org doesn’t indicate this story or any other post is fake, but its About Us link notes that "all articles should be considered satirical and any and all quotes attributed to actual people complete and total baloney." TheLastLineOfDefense.org has developed a regular cottage industry of writing about Foster’s death. The site has previously written posts that said Gowdy had Foster’s body exhumed, then that it went missing from the morgue in Norfolk, or that WikiLeaks has proof of a conspiracy surrounding Foster’s death. The assertion that Foster’s body has been dug up, autopsied again and his death ruled a homicide is completely made up. We rate this statement


Single Dose of Hallucinogenic Drug Psilocybin Relieves Anxiety and Depression in Patients with Advanced Cancer

Explanation: This release focuses on a recent study that found a single application of the hallucinogen psilocybin is effective at providing meaningful relief to cancer patients suffering from severe depression or anxiety. The release notes that 80 percent of participants showed improvement based on clinical evaluation scores for anxiety and depression for several months following the treatment. The study is one of two on the subject that were published recently in the Journal of Psychopharmacology (our review of the release for the other study can be found here and a review of a related news article can be read here.) The release does better than its counterpart in terms of addressing conflicts of interest and placing the work in context with previous work in the field. However, the release uses only vague language when addressing the key issues of health benefits and adverse side effects. More specifics on the degree of reduced anxiety and depression scores would have been useful. Because this study and its counterpart offer an intriguing finding — that a single dose of something could be so helpful in alleviating depression — we’ve completed three reviews related to these studies: one on a news story from the LA Times, one on a news release from Johns Hopkins, and this review on the release from NYU. And the core issues involved are similar across all three items. Cancer is a widespread health problem that affects many millions of Americans. According to the National Cancer Institute, just under 1.7 million people in the United States will be diagnosed with cancer in 2016 alone. If you consider that each of those people has a family and loved ones who are also affected by the diagnosis, you can begin to appreciate the scope of the problem. According to a report from the National Institutes of Health’s 2002 State-of-the-Science Conference on Symptom Management in Cancer: Pain, Depression, and Fatigue, “The clinical ‘rule of thumb’ is that 25 percent of cancer patients are likely depressed enough at some point in the course of disease to warrant evaluation and treatment.” This makes it especially important for research institutions and news outlets to write responsibly about studies like those discussed in this release. You want to give readers enough information to help them make informed decisions. You don’t want to raise false hopes, or sensationalize the work. We think all three summaries on this growing body of research reported responsibly on the findings.

Academic medical center news release,Cancer

The release refers to psilocybin as being “inexpensive,” if and when it were to become a clinical treatment option. However, there is no basis provided for why the drug would be inexpensive or what that means relative to other treatments. Given that it is currently a banned substance, it’s difficult to assess how expensive the drug would be — or in what clinical circumstances it may be used (which could affect the cost for patients). You may be wondering, “How can the release further address cost, given that the relevant drug is a banned substance?” One way would be to specifically note that it is difficult to estimate what the cost of psilocybin treatment would be, given that it is currently a banned substance. The release does tell readers what percentage of patients benefited from psilocybin treatment, but does not explicitly quantify the extent of those benefits — which is what this category is designed to address. Instead, readers are given qualitative assessments of the treatment — that it “significantly lessens mental anguish” and brought “relief from distress.” But those terms are vague. What does “significantly lessens” mean? For example, did patients return to clinically normal levels of anxiety? The release is vague here, noting that patients “experienced no serious negative effects, such as hospitalization or more serious mental health conditions.” But that doesn’t mean they had no side effects. A look at the paper shows that 28 percent of patients, for example, suffered headaches or migraines and 14 percent had nausea. Did the benefits outweigh these effects? Many people might say yes. However, it’s important for research institutions to describe the research — warts and all — and let people make informed decisions. If we think that’s true for clinically available treatments, it should also apply to treatments in the earlier stages of testing. The release does an adequate job of describing the study: the number of patients, their clinical background, the study design. That earns it a satisfactory rating here. No disease mongering here. This is a strength of the release. It not only tells readers who funded the work, but that one of the funding organizations is focused specifically on research involving psychedelic drugs — and that one of the researchers previously served on that organization’s board. The release notes that study participants received counseling in addition to the psilocybin treatment — which is an important point to make. However, the release doesn’t discuss the use of counseling as a stand-alone treatment option for anxiety or depression, nor does the release address other pharmaceutical treatment options that can be used to treat mental health problems. The release would have been much stronger if it had compared the pros and cons of this treatment method with other treatment methods. The release does not specifically address drug availability. However, the release does note that psilocybin is a banned substance, and makes clear that larger clinical trials would have to be successful before psilocybin could be used as a “safe, effective and inexpensive medication — dispensed under strict control.” That’s sufficient to merit a satisfactory rating. The release does a good job here, in two ways. First, it notes that this study (presumably in conjunction with the one from Johns Hopkins) provides “the strongest evidence to date of a clinical benefit from psilocybin therapy.” That’s important context. Second, the release states that psilocybin “has been studied for decades and has an established safety profile.” Again, that’s important context. These points earn it a satisfactory rating. That said, we would like to have seen how this work compares to previous research done specifically on the use of psilocybin to treat anxiety in cancer patients — such as this 2007 study, this one from 2011, or this one from 2013. We don’t necessarily expect an exhaustive comparison, but the release would have been stronger if there had been some acknowledgment that other work has been done in this field over the past 10 years. More specifically, it would have been nice to see a sentence or two highlighting how the new findings are similar to, or different from, the existing body of work in the field. This one was actually a close call, particularly because of one line in the release. In the third paragraph, the release states that “Study results were also endorsed in 11 accompanying editorials from leading experts in psychiatry, addiction, and palliative care.” Cautious optimism may be a more accurate description of some of those editorials. However, much depends on how one chooses to interpret the word “endorse.” Given that all of the editorials acknowledge the work, and that is a reasonable interpretation of the word “endorse,” we’ll give it a pass. However, given that “endorse” can also be read as actively supporting or promoting something, we wish they had chosen different language.


Hepatitis C Drug Raises Cure Rate in Late Trial

Explanation: This is basically a stock market performance story dressed up as a clinical trial story, one of many such stories where someone on the business desk is asked to write about a "breakthrough" for the purposes of giving investors/readers some insight on where to make their next investment move. Because the reporter is well above average, the story is packed with information about the trial, about the drug, about hepatitis and about the company. But there is quite a bit of information missing that would be helpful for patients who, most likely, aren’t going to see perhaps unfounded hope in phrases such as, "a new era in treating a sometimes fatal disease." Even in a stock market story, it is important to get the clinical part right. And, especially in a stock market story, it is important to get the cost part right.

If you can estimate that a drug is going to have sales of "$3 billion a year by 2015," then you can estimate how much it is going to cost patients and how much more it is going to cost over existing treatments. This story does neither. The story talks a lot about the benefits but doesn’t really quantify them. Given that 1,095 patients were in the trial, let’s assume that half were in the drug group and half in the placebo group. Of the drug group, let’s assume half were in the 24 week group and half were in the eight week group. By our math, that means that about 154 people had better outcomes than those in the control group. Also, the story does a pretty good job of walking people through the results, but the story is framed as a "new era" versus an old, torturous treatment. Only when you get to the end of the story do you realize that the new drug only works in combination with the old, torturous treatment. So the torture is not going away, it’s just taking on a new layer of medication, and new costs. Relapses after completing therapy are common with standard therapy of IFN and ribavirin. In a recently published study in the NEJM involving patients who had previously failed IFN and ribavirin, there was a 76% "cure" at the end of the treatment period, but only a 51% "cure" 24 weeks after the end of treatment. So in the data reported in this article, is the 75% "cure" 24 weeks after the end of treatment or is it at the end of the treatment period? Finally, the information presented doesn’t translate into how many patients need to be treated to have one meaningful cure. The story makes the standard treatment sound terrible. But it glosses over the side effects of the new treatment, saying only that it causes a "nasty rash." Where is the rash? That can make a world of difference. Does it cause the skin to break and bleed? Does it interfere with basic functions like sight, breathing, eating? It says that 7% of the people in the drug group dropped out, while about half that percentage dropped out of the placebo group. Again, some absolute numbers would be good here, as would some context about what percentage of patients experience side effects with the standard treatment or with the competing drug in the same family of drugs mentioned earlier in the story. And the story could have been more clear that all patients get the standard therapy, IFN and ribavirin. So they will face the side effects of the current regimen, PLUS the side effects of this new agent. There are a lot of numbers in this story, but there are two crucial numbers missing: the absolute risk reduction and the number needed to treat. It says at the top that "about 75 percent of patients in the trial who got the standard dose of Vertex’s drug in combination with the existing treatment were essentially cured, compared with 44 percent of those who got only the existing therapy." Later it says that "in Vertex’s trial, about 70 percent of those who achieved an effective cure were able to do so in 24 weeks, or about six months." Then it says "Patients got either 12 weeks or eight weeks of telaprevir or a placebo. The standard therapy of interferon and ribavirin was given for either 24 weeks or 48 weeks, depending on how the patients were faring after four weeks and 12 weeks. Of those who got 12 weeks of telaprevir, 75 percent had a sustained viral response, meaning the virus was not detectable in their blood 24 weeks after completing treatment. That is seen as essentially a cure. The rate was 69 percent for those who got eight weeks of telaprevir." More on this later. Finally, it is not clear where any of this data came from. In searching for the primary source information, it appears to come from the company itself rather than from publication in a medical journal. The description of the scope of the disease is fairly standard and well sourced. "Some 2.7 million to 3.9 million Americans are estimated to have hepatitis C, and 12,000 die from it each year, according to a recent report by the Institute of Medicine. The disease can cause cirrhosis, which is a scarring of the liver, as well as liver cancer. The virus is transmitted by blood, so most people who have hepatitis C either have injected illegal drugs or received blood transfusions or blood products before the early 1990s." We wish we’d seen a source on the idea that most recent Hep C patients have injected illegal drugs. We would have liked to have seen independent voices inject more context into the story, but the reporter did at a minimum take these results to another legitimate researcher. The reporter also went to a patient advocacy group that, unfortunately, just spat out the standard "we welcome any cure" spiel. The comparison could have been more detailed, but, you do get the picture that this new drug will simply be an add on to existing therapies, albeit with the potential for cutting down the treatment time considerably. The second word in the story is "experimental." It talks about the drug being in three different Phase 3 clinical trials and about the company looking forward to applying for approval from the FDA. What it does not do is make it clear how quickly the drug could be brought to market (or slowly) especially given the problems of side effects also noted in the story. The storyt makes clear that this is a new treatment that is not yet FDA approved – a novel agent and class. Not applicable because we can’t be sure of the extent to which a news release impacted this story. But we also can’t figure out what the source is of the information provided unless it’s the company.