con Alabama Real Estate Investor Pleads Guilty to Conspiracy to Commit Mail Fraud By www.justice.gov Published On :: Mon, 3 Nov 2014 14:58:31 EST An Alabama real estate investor pleaded guilty yesterday for his role in a conspiracy to commit mail fraud related to public real estate foreclosure auctions held in southern Alabama, the Department of Justice announced today Full Article OPA Press Releases
con Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud Conspiracies at Public Foreclosure Auctions By www.justice.gov Published On :: Thu, 9 Apr 2015 12:52:09 EDT A Northern California real estate investor has agreed to plead guilty for his role in bid rigging and fraud conspiracies at public real estate foreclosure auctions in Northern California, the Department of Justice announced Full Article OPA Press Releases
con Deutsche Bank's London Subsidiary Agrees to Plead Guilty in Connection with Long-Running Manipulation of LIBOR By www.justice.gov Published On :: Fri, 24 Apr 2015 09:35:43 EDT DB Group Services (UK) Limited, a wholly owned subsidiary of Deutsche Bank AG (Deutsche Bank), has agreed to plead guilty to wire fraud for its role in manipulating the London Interbank Offered Rate (LIBOR), a leading benchmark interest rate used in financial products and transactions around the world Full Article OPA Press Releases
con Father Of Former Investment Bank Managing Director Pleads Guilty To Insider Trading Conspiracy By www.justice.gov Published On :: Wed, 12 Aug 2015 21:09:53 EDT Preet Bharara, the United States Attorney for the Southern District of New York, announced that ROBERT STEWART, the father of former investment bank managing director Sean Stewart, pled guilty today to participating in a conspiracy to trade on inside information about several mergers and acquisitions announced between 2011 and 2014 Full Article OPA Press Releases
con Real Estate Investor Pleads Guilty to Bid Rigging and Fraud Conspiracies at Georgia Public Foreclosure Auctions By www.justice.gov Published On :: Wed, 7 Oct 2015 20:45:21 EDT A Georgia real estate investor pleaded guilty today for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Fulton and DeKalb counties, Georgia Full Article OPA Press Releases
con Deputy Attorney General Sally Quillian Yates Delivers Remarks at American Banking Association and American Bar Association Money Laundering Enforcement Conference By www.justice.gov Published On :: Fri, 18 Dec 2015 11:45:40 EST Remarks as prepared for delivery Thank you, Buddy [Wilmer Parker], for that kind introduction Full Article Speech
con Executives of Swiss and Las Vegas Companies Convicted in International Investment Fraud Scheme By www.justice.gov Published On :: Thu, 10 Dec 2015 08:45:28 EST A federal jury in Las Vegas convicted two men of conspiracy, wire fraud and securities fraud yesterday for their roles in an approximately $10 million international investment fraud scheme involving numerous victims Full Article OPA Press Releases
con Former Idaho Construction Company President Sentenced to Prison for Fraud Scheme By www.justice.gov Published On :: Mon, 8 Feb 2016 20:45:26 EST The former president and majority stockholder of a construction company was sentenced to five years in prison today following her plea of guilty to filing a false tax return and her conviction by a jury of conspiracy to defraud the United States, wire fraud, mail fraud, false statements, interstate transportation of property taken by fraud, conspiracy to obstruct justice and obstruction of justice, announced Acting Assistant Attorney General Caroline D. Ciraolo of the Justice Department’s Tax Division and U.S. Attorney Wendy J. Olson for the District of Idaho. Full Article OPA Press Releases
con Morgan Stanley Agrees to Pay $2.6 Billion Penalty in Connection with Its Sale of Residential Mortgage Backed Securities By www.justice.gov Published On :: Wed, 17 Feb 2016 19:56:23 EST The Justice Department today announced that Morgan Stanley will pay a $2 Full Article OPA Press Releases
con New York Man Pleads Guilty to Conspiracy to Defraud U.S. Defense Contractors By www.justice.gov Published On :: Tue, 29 Mar 2016 20:45:42 EDT ALEXANDRIA, Va Full Article OPA Press Releases
con Two Former Deutsche Bank Employees Indicted on Fraud Charges in Connection with Long-Running Manipulation of Libor By www.justice.gov Published On :: Thu, 2 Jun 2016 14:45:33 EDT Two former Deutsche Bank AG (Deutsche Bank) traders—the bank’s supervisor of the Pool Trading Desk in New York and a derivatives trader in London—were indicted for their alleged roles in a scheme to manipulate the U Full Article OPA Press Releases
con Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic By feedproxy.google.com Published On :: Wed, 29 Apr 2020 13:00:12 +0000 By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications … Continue reading » Full Article Clinical Trials CATOSMS COVID-19
con Will Krystal (KRYS) Continue To Shine? By www.rttnews.com Published On :: Thu, 07 May 2020 09:23:26 GMT Shares of Krystal Biotech Inc. (KRYS) have now more than doubled in value since touching a 52-week low of $22.02 on June 14, 2019. Full Article
con Pew Urges Congress to Promote Patient Matching in Electronic Health Records to Address COVID-19 By feedproxy.google.com Published On :: Mon, 04 May 2020 13:32:47 -0400 The Pew Charitable Trusts sent a letter May 4 to the leaders of the Senate and House of Representatives urging them to support improved patient matching in electronic health records to help combat the COVID-19 pandemic. Full Article
con Why Words Matter in the Substance Use Conversation By feedproxy.google.com Published On :: Tue, 05 May 2020 10:16:00 -0400 In any public health or policy issue, it is important to consider the language used to discuss the people affected. The nation’s prolonged opioid crisis continues to touch many communities and families, and the way in which experts and others talk about substance use disorders, their causes, and the solutions is evolving. Full Article
con Confessions Of A Planner By feedproxy.google.com Published On :: Fri, 03 Apr 2020 11:04:06 +0000 This blog was written by Samantha Truex, CEO of Quench Bio, as part of the From The Trenches feature of LifeSciVC. I am a planner. I like to plan most things well in advance; in fact, maybe too far in The post Confessions Of A Planner appeared first on LifeSciVC. Full Article From The Trenches Biotech COVID strategic planning
con Amin Talati Continues its Expansion in Washington DC With Addition Of Dietary Supplement Industry Leader By feedproxy.google.com Published On :: Mon, 05 Feb 2018 17:56:00 GMT Rend Al-Mondhiry has joined the firm Amin Talati from the Council for Responsible Nutrition (CRN) as Senior Counsel, resident in the Washington, D.C. Office. Full Article
con Probi's Largest Clinical Trial Confirms the Immune Enhancing Impact of Probi Defendum® By feedproxy.google.com Published On :: Tue, 06 Feb 2018 17:01:00 GMT Probi's largest clinical trial ever, focused on probiotic immune health, has recently been completed. Full Article
con The Health Care Practitioner Channel: Connecting Industry and Medical Professionals By feedproxy.google.com Published On :: Wed, 07 Feb 2018 14:57:00 GMT Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too. Full Article
con DSM Insight Series: 1 in 4 Consumers Prepare, Consume Breakfast in Less Than 5 Minutes By feedproxy.google.com Published On :: Thu, 08 Feb 2018 16:24:00 GMT DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US. Full Article
con CRN Launches #SARMsCanHarm Consumer Education Initiative to Raise Awareness of SARMs Dangers By feedproxy.google.com Published On :: Fri, 09 Feb 2018 16:23:00 GMT The Council for Responsible Nutrition announced the launch of a consumer education initiative designed to raise awareness of Selective Androgen Receptor Modulators, a dangerous class of ingredients. Full Article
con Successfully Choosing and Maintaining a Contract Manufacturing Partnership By feedproxy.google.com Published On :: Tue, 13 Feb 2018 15:59:00 GMT In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership. Full Article
con Finalists of APEC Healthy Women, Healthy Economy Prize Announced By www.apec.org Published On :: Fri, 27 Sep 2019 11:22:00 +0800 Equal pay, migrant workers, and maternal health are the issues highlighted by the finalists of the inaugural APEC Healthy Women, Healthy Economies Research Prize. Full Article
con Inaugural Healthy Women Health Economies Prize Announces Winning Research By www.apec.org Published On :: Wed, 02 Oct 2019 18:19:00 +0800 A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award. Full Article
con APEC Ministers in Charge of Women’s Economic Participation Issue Joint Statement By www.apec.org Published On :: Fri, 04 Oct 2019 22:45:00 +0800 Ministers in charge of women’s economic participation in the APEC region issued a joint statement following their meeting in La Serena, Chile, on 4 October 2019. Full Article
con APEC Economies Agree on Principles and Actions to Support Women in Science, Technology, Engineering, and Mathematics By www.apec.org Published On :: Tue, 15 Oct 2019 12:30:00 +0800 APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM. Full Article
con APEC Finance Ministers Call for Economic Resilience and Financial Inclusion By www.apec.org Published On :: Tue, 15 Oct 2019 22:20:00 +0800 Ministers address developments in the global economy and take action to safeguard the region’s growth. Full Article
con Consensus Fosters Sustainable and Inclusive Growth: APEC Senior Officials By www.apec.org Published On :: Sat, 07 Dec 2019 15:30:00 +0800 Members of the Asia-Pacific Economic Cooperation (APEC) will continue to work together towards more inclusive and sustainable growth, pledged APEC Senior Officials at the concluding event for Chile’s host year of APEC. Full Article
con Winner of 2019 APEC Photo Contest Also Wins Popular Choice Award By www.apec.org Published On :: Sun, 08 Dec 2019 12:24:00 +0800 The winner of the APEC Photo Contest 2019 has also won the most votes for the Popular Choice Award, announced the APEC Secretariat. Full Article
con Chinese Taipei Adds Contribution for Inclusive Growth Initiatives By www.apec.org Published On :: Mon, 09 Dec 2019 17:07:00 +0800 Chinese Taipei has voluntarily contributed USD 550,000 in funding to support APEC initiatives that advance regional economic integration and inclusive sustainable growth across the Asia-Pacific. Full Article
con Biodiversity Essential to APEC Economies By www.apec.org Published On :: Mon, 10 Feb 2020 14:12:00 +0800 2020 APEC Science Prize Open for Nominations Full Article
con APEC Needs to Look Beyond Numbers, Bring Concrete Benefits to People By www.apec.org Published On :: Thu, 20 Feb 2020 16:32:00 +0800 Enable trade and investments to generate concrete outcomes for the people. Full Article
con Tapping the Economic Potential of Women By www.apec.org Published On :: Mon, 09 Mar 2020 06:00:00 +0800 La Serena Roadmap for Women and Inclusive Growth to bolster progress Full Article
con FDA DOC vs general use of consensus standard By connect.raps.org Published On :: Thu, 07 May 2020 08:53:38 -0400 From : Communities>>Regulatory Open ForumThis message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304- ANSI AAMI IEC 62304:2006/A1:2016 62366-1:2015- Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More] Full Article Discussion
con RE: FDA DOC vs general use of consensus standard By connect.raps.org Published On :: Thu, 07 May 2020 17:08:00 -0400 From : Communities>>Regulatory Open ForumThis message was posted by a user wishing to remain anonymous I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material. Here was a nice thread discussing the topic [More] Full Article Discussion
con RE: FDA DOC vs general use of consensus standard By connect.raps.org Published On :: Fri, 08 May 2020 05:42:28 -0400 From : Communities>>Regulatory Open ForumHello Anonymous You will be generating software documents (which is data of a sort), in accordance with ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission. I just think DoCs are wasteful busy time and would do as few as possible. Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device usability study is not required in a submission don't put it in there unless asked. Just my opinion. Biocompatibility if used, is generating test [More] Full Article Discussion
con RE: FDA DOC vs general use of consensus standard By connect.raps.org Published On :: Sat, 09 May 2020 03:13:41 -0400 From : Communities>>Regulatory Open ForumHello, I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation. These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following. I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, [More] Full Article Discussion
con Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma By www.news.sanofi.us Published On :: Tue, 05 May 2020 08:25:00 -0400 Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC) Full Article
con Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia By www.gabionline.net Published On :: Mon, 04 May 2020 08:08:24 +0000 US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients. Full Article
con Non-innovator biologicals in India: regulatory context and areas for improvement By www.gabionline.net Published On :: Mon, 04 May 2020 08:14:37 +0000 There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal. Full Article
con The COVID-19 Pandemic and Maintenance of a Continued Safe Food Supply By strengthenfda.org Published On :: Fri, 17 Apr 2020 18:38:51 +0000 The Alliance met (virtually) on April 15 with Dr. Caitlin Boon, FDA Associate Commissioner for Food Policy and Response and several of her colleagues. She described CFSAN’s and CVM’s role in responding to the current pandemic, as well as how the agency is assuring a continued safe food supply. About 50% of food spending in the […] Full Article Analysis and Commentary Boon chain coronavirus Food safety supply
con How Can Congress Agree to Appropriations for FY 21? By strengthenfda.org Published On :: Fri, 24 Apr 2020 17:35:23 +0000 Q: Congress must act on FY 21 appropriations. What are the possible ways for Congress to address this? A: Congress must decide if they will do substantive work on the 12 appropriations bills with the goal of passing full-year funding bills before October 1. One alternative would be to fund the beginning of the fiscal year […] Full Article Analysis and Commentary appropriation cap Congress continuing resolution
con Ebola is not the only health concern for Africans or Americans: how Egypt aims to improve its drug quality oversight By searchingforsafety.net Published On :: Thu, 30 Oct 2014 14:51:38 GMT Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...] Full Article Uncategorized
con A Conservative Legal Group Significantly Miscalculated Data in a Report on Mail-In Voting By tracking.feedpress.it Published On :: 2020-05-02T11:45:00-04:00 by Derek Willis ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued. However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018. The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.” PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity. The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail. Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing. “Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email. A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues. PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots. In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads. In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview. But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said. The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions. In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.” Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud. Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting. Full Article
con The Bigoted, Conspiratorial Rants of Rudy Giuliani’s Radio Show By tracking.feedpress.it Published On :: 2020-05-04T12:45:00-04:00 by Alice Wilder, WNYC Stay up to date with email updates about WNYC and ProPublica’s investigations into the president’s business practices. This story was co-published with WNYC. Presidential lawyer and former New York City Mayor Rudy Giuliani has largely fallen out of the public eye since his starring role in President Donald Trump’s impeachment. But Giuliani hasn’t gone silent. Instead, he’s in his home, doing a call-in radio show and a podcast — “Common Sense” — during which he has repeatedly gone on bigoted rants about China and its government. “They have no morals,” he said on his April 28 radio show. “They’re amoral in the sense that human life means something in Western civilization, it means a lot. Human life doesn’t mean the same thing to them.” Giuliani has also speculated that the spread of the coronavirus may be a plot by the Chinese government. For example, Giuliani has raised the possibility that China purposely released the virus from a biological lab in Wuhan. “We have to say accidentally,” Giuliani said in a recent radio broadcast. “But I don’t think as responsible investigators we can rule out that it wasn’t done deliberately.” Experts say there’s no public evidence the virus came from the lab. Amid a reported White House push, U.S. intelligence agencies have said they are investigating the origins of the virus. Giuliani is also fixated on the idea that the Chinese government sent sick people overseas. In an April 27 episode of his podcast, he said that China allowed “over a million people from Wuhan travel to us, to the United States, to England to France to Italy to Germany.” He added, “I hope the people there have the same reaction we have to the value of human life and the loss of human life.” “When they found out about this terrible virus that escaped, assuming they didn’t do it on purpose,” Giuliani said a day later on his radio show, “they were going to make sure the West suffered as much if not more than they did and jumped on top of an opportunity, it’s not a big assumption to make. And there isn’t a contrary explanation.” The New York Times found that thousands, not millions, of people flew internationally out of Wuhan. Asked about his comments, Giuliani did not respond. The comments by Giuliani have come as discrimination against Asian Americans has spiked. And they reinforce the White House’s emerging push to blame China for the pandemic. Giuliani has said he’s spoken to the president a number of times about the coronavirus. Two days after Giuliani said he was sure the virus came from the Wuhan lab, Trump said he has evidence of the same. (The president declined to give the evidence, saying it’s secret.) Giuliani appears to have found a receptive wider audience too. An advertising executive at 77 WABC, which airs Giuliani’s radio show, said “feedback has been amazing” and online listening has “skyrocketed.” The station’s parent company, Red Apple Media, did not respond to a request for comment. In an April 23 radio show, Giuliani interviewed Gordon Chang, a conservative pundit who frequently predicts the collapse of the Chinese government. Chang said if China released the virus accidentally — for which, again, there’s no evidence — it then decided to create a global pandemic. “I think what Xi Jinping did was he decided he was going to spread the virus so that he would level the playing field so that China would not be in such a hole,” Chang said, referring to China’s president. “Wow,” Giuliani responded. “So he saw an opportunity, if that theory is correct, and it wasn’t a bioweapon to start with, he saw an opportunity that was sort of accidentally presented to him, and then he took advantage of it. It was opportunistic.” Chang acknowledged, “We can’t know what was in Xi Jinping’s mind for sure.” But then he went on, “It looks more like they were deliberate and malicious and that means Mr. Mayor ... this is a crime against all of humanity.” Giuliani ended the interview by inviting Chang to be a guest on his other show, the podcast. Giuliani has also said he’d use his access to help guests on his show move ahead with exploratory treatments. Talking with one pharmaceutical executive on his show in late March, Giuliani told his guest, “I’ll use whatever my yelling and screaming can do to do it faster, to help you.” As the Times reported, the executive’s company received initial trial approval from the Food and Drug Administration soon after. (The FDA has said the application was subject to “internal scientific review.” And Giuliani has said he has no business connection to the company.) “I don’t lobby the government,” Giuliani emailed in response to a request for comment. “I do hope, however, that they and others are successful.” Giuliani appears to have strong feelings about the government’s process for approving drugs. In an April 23 broadcast, Mark, a pharmacist from New Jersey, called in to report on his “informal study” of the patients who have used a drug cocktail that includes hydroxychloroquine — the anti-malaria drug that Trump long has touted. Giuliani was excited when Mark reported that none of his patients had been hospitalized: “Why doesn’t this count with all these geniuses in Washington? The double blind study and the triple blind study and this study and that study, we don’t have time for that, we’ve got to go to people like Mark in New Jersey!” In fact, the FDA has warned against widespread use of the drug, noting that it can cause heart problems. The discussions with his listeners, though, often come back to China. One caller to Giuliani’s radio show, identifying himself as “George from Bay Ridge,” went on a rant against Chinese people, likening them to serial killers with “no conscience” who are attempting to take over businesses all over the world. Giuliani responded, “George, I’ve been getting complaints about this for a long time.” He added: “It almost reminds me of the Mafia. You know, they say, if you do business with America it’s one thing. If you do business with China you don’t realize, all of a sudden you start owing them too much and they believe they own you.” Full Article
con Trump Hasn’t Released Funds That Help Families of COVID-19 Victims Pay for Burials. Members of Congress Want to Change That. By tracking.feedpress.it Published On :: 2020-05-04T13:45:00-04:00 by Yeganeh Torbati ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies. “Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.” ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead. Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.” In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday. The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March. On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures. Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak. The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million. Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely. Full Article
con How Climate Change Is Contributing to Skyrocketing Rates of Infectious Disease By tracking.feedpress.it Published On :: 2020-05-07T05:00:00-04:00 by Abrahm Lustgarten ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The scientists who study how diseases emerge in a changing environment knew this moment was coming. Climate change is making outbreaks of disease more common and more dangerous. Over the past few decades, the number of emerging infectious diseases that spread to people — especially coronaviruses and other respiratory illnesses believed to have come from bats and birds — has skyrocketed. A new emerging disease surfaces five times a year. One study estimates that more than 3,200 strains of coronaviruses already exist among bats, awaiting an opportunity to jump to people. The diseases may have always been there, buried deep in wild and remote places out of reach of people. But until now, the planet’s natural defense systems were better at fighting them off. Today, climate warming is demolishing those defense systems, driving a catastrophic loss in biodiversity that, when coupled with reckless deforestation and aggressive conversion of wildland for economic development, pushes farms and people closer to the wild and opens the gates for the spread of disease. Aaron Bernstein, the interim director for the C-Change Center for Climate, Health and the Global Environment at Harvard University’s T.H. Chan School of Public Health, said that ignoring how climate and rapid land development were putting disease-carrying animals in a squeeze was akin to playing Russian roulette. “Nature is trying to tell us something,” Bernstein said. Scientists have not suggested that climate played any direct role in causing the current COVID-19 outbreak. Though the virus is believed to have originated with the horseshoe bat, part of a genus that’s been roaming the forests of the planet for 40 million years and thrives in the remote jungles of south China, even that remains uncertain. Scientists have, however, been studying the coronaviruses of southern China for years and warning that swift climate and environmental change there — in both loss of biodiversity and encroachment by civilization — was going to help new viruses jump to people. There are three ways climate influences emerging diseases. Roughly 60% of new pathogens come from animals — including those pressured by diversity loss — and roughly one-third of those can be directly attributed to changes in human land use, meaning deforestation, the introduction of farming, development or resource extraction in otherwise natural settings. Vector-borne diseases — those carried by insects like mosquitoes and ticks and transferred in the blood of infected people — are also on the rise as warming weather and erratic precipitation vastly expand the geographic regions vulnerable to contagion. Climate is even bringing old viruses back from the dead, thawing zombie contagions like the anthrax released from a frozen reindeer in 2016, which can come down from the arctic and haunt us from the past. Thus the COVID-19 pandemic, even as it unfolds in the form of an urgent crisis, is offering a larger lesson. It is demonstrating in real time the enormous and undeniable power that nature has over civilization and even over its politics. That alone may make the pandemic prologue for more far-reaching and disruptive changes to come. But it also makes clear that climate policy today is indivisible from efforts to prevent new infectious outbreaks, or, as Bernstein put it, the notion that climate and health and environmental policy might not be related is “a dangerous delusion.” The warming of the climate is one of the principal drivers of the greatest — and fastest — loss of species diversity in the history of the planet, as shifting climate patterns force species to change habitats, push them into new regions or threaten their food and water supplies. What’s known as biodiversity is critical because the natural variety of plants and animals lends each species greater resiliency against threat and together offers a delicately balanced safety net for natural systems. As diversity wanes, the balance is upset, and remaining species are both more vulnerable to human influences and, according to a landmark 2010 study in the journal Nature, more likely to pass along powerful pathogens. The casualties are amplified by civilization’s relentless push into forests and wild areas on the hunt for timber, cropland and other natural resources. Epidemiologists tracking the root of disease in South Asia have learned that even incremental and seemingly manageable injuries to local environments — say, the construction of a livestock farm adjacent to stressed natural forest — can add up to outsized consequences. Around the world, according to the World Resources Institute, only 15% of the planet’s forests remain intact. The rest have been cut down, degraded or fragmented to the point that they disrupt the natural ecosystems that depend on them. As the forests die, and grasslands and wetlands are also destroyed, biodiversity sharply decreases further. The United Nations warns that the number of species on the planet has already dropped by 20% and that more than a million animal and plant species now face extinction. Losing species has, in certain cases, translated directly to a rise in infectious disease. Peatland fires in Indonesia in 2018 used to clear forests for palm oil plantations. Deforestation is one of the largest drivers of the emergence of new infectious diseases. (Wahyudi/AFP via Getty Image) Americans have been experiencing this phenomenon directly in recent years as migratory birds have become less diverse and the threat posed by West Nile encephalitis has spread. It turns out that the birds that host the disease happen to also be the tough ones that prevail amid a thinned population. Those survivors have supported higher infection rates in mosquitoes and more spread to people. Similarly, a study published last month in the journal Proceedings of the Royal Society B found that as larger mammals suffer declines at the hands of hunters or loggers or shifting climate patterns, smaller species, including bats, rats and other rodents, are thriving, either because they are more resilient to the degraded environment or they are able to live better among people. It is these small animals, the ones that manage to find food in garbage cans or build nests in the eaves of buildings, that are proving most adaptable to human interference and also happen to spread disease. Rodents alone accounted for more than 60% of all the diseases transmitted from animals to people, the researchers found. Warmer temperatures and higher rainfall associated with climate change — coupled with the loss of predators — are bound to make the rodent problem worse, with calamitous implications. In 1999, for example, parts of Panama saw three times as much rainfall as usual. The rat population exploded, researchers found. And so did the viruses rats carry, along with the chances those viruses would jump to people. That same year, a fatal lung disease transmitted through the saliva, feces and urine of rats and mice called hantavirus pulmonary syndrome emerged in Panama for the first time, according to a report in the journal Emerging Infectious Diseases. As much as weather changes can drive changes in species, so does altering the landscape for new farms and new cities. In fact, researchers attribute a full 30% of emerging contagion to what they call “land use change.” Nothing drives land use shifts more than conversion for farmland and feedstock — a result of the push to feed the planet’s 7.8 billion people. As the global population surges to 10 billion over the next 35 years, and the capacity to farm food is stressed further again by the warming climate, the demand for land will only get more intense. Already, more than one-third of the planet’s land surface, and three-quarters of all of its fresh water, go toward the cultivation of crops and raising of livestock. These are the places where infectious diseases spread most often. Take, for example, the 1999 Nipah outbreak in Malaysia — the true-life subject matter adapted for the film “Contagion.” Rapid clearcutting of the forests there to make way for palm plantations drove fruit bats to the edge of the trees. (Separate research also suggests that climate changes are shifting fruit bats’ food supply.) They found places to roost, as it happens, alongside a hog farm. As the bats gorged themselves on fruit, they dropped pieces of food from the branches, along with their urine, into the pigsties, where at least one pig is believed to have eaten some. When the pig was slaughtered and brought to market, an outbreak is believed to have been spread by the man who handled the meat. More than 100 people died. The U.S. Centers for Disease Control and Prevention says that fully three-quarters of all new viruses have emerged from animals. Even the 2014 Ebola outbreak in West Africa is believed to have begun when a boy dug into a tree stump that happened to be the roost of bats carrying the virus. As Christine Johnson, the associate director of the One Health Institute, an interdisciplinary epidemiological program at the University of California, Davis, puts it, global health policymakers have a responsibility to understand how climate, habitat and land use changes lead to disease. Almost every major epidemic we know of over the past couple of decades — SARS, COVID-19, Ebola and Nipah virus — jumped to people from wildlife enduring extreme climate and habitat strain, and still, “we’re naive to them,” she said. “That puts us in a dangerous place.” Once new diseases are let loose in our environment, changing temperatures and precipitation are also changing how those diseases spread — and not for the better. Warming climates increase the range within which a disease can find a home, especially those transmitted by “vectors,” mosquitoes and ticks that carry a pathogen from its primary host to its new victim. A 2008 study in the journal Nature found nearly one-third of emerging infectious diseases over the past 10 years were vector-borne, and that the jumps matched unusual changes in the climate. Especially in cases where insects like infection-bearing mosquitoes are chasing warmer temperatures, the study said, “climate change may drive the emergence of diseases.” A mosquito in a laboratory of the Friedrich-Loeffler Institute in Germany. Scientists say at least 500 million more people, including 55 million more Americans, will be susceptible to mosquito-borne diseases as the climate warms. (Steffen Kugler/Getty Images) Ticks and mosquitoes now thrive in places they’d never ventured before. As tropical species move northward, they are bringing dangerous pathogens with them. The Zika virus or Chikungunya, a mosquito-spread virus that manifests in intense joint pain, were once unseen in the United States, but both were transmitted locally, not brought home by travelers, in southern Texas and Florida in recent years. Soon, they’ll be spreading further northward. According to a 2019 study in the journal PLOS Neglected Tropical Diseases, by 2050, disease-carrying mosquitoes will ultimately reach 500 million more people than they do today, including some 55 million more Americans. In 2013, dengue fever — an affliction affecting nearly 400 million people a year, but normally associated with the poorest regions of Africa — was transmitted locally in New York for the first time. “The long-term risk from dengue may be much higher than COVID,” said Scott Weaver, the director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch in Galveston. “It’s a disease of poor countries, so it doesn’t get the attention it deserves.” The chain of events that ultimately leads to a pandemic can be long and subtle, steered by shifts in the ecosystem. The 1999 West Nile outbreak in the U.S., for example, came after climate-driven droughts dried up streams and rivers, leaving pools of stagnant water where mosquitoes bred unhindered. It turns out the loss of water also killed off their predators — dragonflies and frogs that depend on large watering holes were gone. Coronaviruses like COVID-19 aren’t likely to be carried by insects — they don’t leave enough infected virus cells in the blood. But one in five other viruses transmitted from animals to people are vector-borne, said U.C. Davis’ Johnson, meaning it’s only a matter of time before other exotic animal-driven pathogens are driven from the forests of the global tropics to the United States or Canada or Europe because of the warming climate. “Climate is going to shift vulnerability to that,” Johnson said, “and I think some of these regions are not prepared.” The changing climate won’t just affect how the diseases move about the planet, it will also shape how easily we get sick. According to a 2013 study in the journal PLOS Currents Influenza, warm winters were predictors of the most severe flu seasons in the following year. The brief respite in year one, it turns out, relaxed people’s natural defenses and reduced “herd immunity,” setting conditions for the virus to rage back with a vengeance. Even harsh swings from hot to cold, or sudden storms — exactly the kinds of climate-induced patterns we’re already seeing — make people more likely to get sick. A study in the journal Environmental Research Letters linked the brutal 2017-18 flu season — which killed 79,000 people — to erratic temperature swings and extreme weather that winter, the same period in which a spate of floods and hurricanes devastated much of the country. If the climate crisis continues on its current trajectory, the authors wrote, respiratory infections like the flu will sharply increase. The chance of a flu epidemic in America’s most populated cities will increase by as much as 50% this century, and flu-related deaths in Europe could also jump by 50%. “We’re on a very dangerous path right now,” said the University of Texas’ Weaver. Slow action on climate has made dramatic warming and large-scale environmental changes inevitable, he said, “and I think that increases in disease are going to come along with it.” Twelve months before the first COVID-19 case was diagnosed, a group of epidemiologists working with a U.S. Agency for International Development project called PREDICT, or Pandemic Influenza and other Emerging Threats, was deep in the remote leafy jungle of southern China’s Yunnan province hunting for what it believed to be one of the greatest dangers to civilization: a wellspring of emerging viruses. A decade of study there had identified a pattern of obscure illnesses affecting remote villagers who used bat guano as fertilizer and sometimes for medicine. Scientists traced dozens of unnamed, emerging viruses to caves inhabited by horseshoe bats. Any one of them might have triggered a global pandemic killing a million people. But luck — and mostly luck alone — had so far kept the viruses from leaping out of those remote communities and into the mainstream population. The luck is likely to run out, as Yunnan is undergoing enormous change. Quaint subsistence farm plots were overtaken by hastily erected apartment towers and high-speed rail lines, as the province endured dizzying development fueled by decades of Chinese economic expansion. Cities’ footprints swelled, pushing back the forests. More people moved into rural places and the wildlife trade, common to such frontier regions, thrived. With every new person and every felled tree, the bats’ habitat shrank, putting the viruses they carried on a collision course with humanity. By late 2018, epidemiologists there were bracing for what they call “spillover,” or the failure to keep a virus locally contained as it jumped from the bats and villages of Yunnan into the wider world. In late 2018, the Trump administration, as part of a sweeping effort to bring U.S. programs in China to a halt, abruptly shut down the research — and its efforts to intercept the spread of a new novel coronavirus along with it. “We got a cease and desist,” said Dennis Carroll, who founded the PREDICT program and has been instrumental in global work to address the risks from emerging viruses. By late 2019, USAID had cut the program’s global funding. USAID did not respond to a detailed list of questions from ProPublica. The loss is immense. The researchers believed they were on the cusp of a breakthrough, racing to sequence the genes of the coronaviruses they’d extracted from the horseshoe bat and to begin work on vaccines. They’d campaigned for years for policymakers to fully consider what they’d learned about how land development and climate changes were driving the spread of disease, and they thought their research could literally provide governments a map to the hot spots most likely to spawn the next pandemic. They also hoped the genetic material they’d collected could lead to a vaccine not just for one lethal variation of COVID, but perhaps — like a missile defense shield for the biosphere — to address a whole family of viruses at once. (In fact, the gene work they were able to complete was used to test the efficacy of remdesivir, an experimental drug that early clinical trial data shows can help COVID-19 patients.) Carroll said knowledge of the virus genomes had the potential “to totally transform how we think about future biomedical interventions before there’s an emergence.” His goal was to not just react to a pandemic, but to change the very definition of preparedness. If PREDICT’s efforts in China had the remote potential to fend off the current COVID pandemic, though, it also offered an opportunity to study how climate and land development were driving disease. But there has been little appetite for that inquiry among policymakers. PREDICT’s staff and advisers have pushed the U.S. government to consider how welding public health policy with environmental and climate science could help stem the spread of contagions. Climate change was featured in presentations that PREDICT staff made to Congress, according to U.C. Davis’ Johnson, who is now also the director of PREDICT, which received a temporary funding extension this spring. And until 2016, leadership of New York-based EcoHealth Alliance, the research group working under PREDICT funding in Yunnan, was invited several times to the White House to advise on global health policy. Since Donald Trump was elected, the group hasn’t been invited back. “It’s falling on deaf ears,” said Peter Daszak, EcoHealth Alliance’s president. A White House spokesperson did not respond to an emailed request for comment. What Daszak really wants — in addition to restored funding to continue his work — is the public and leaders to understand that it’s human behavior driving the rise in disease, just as it drives the climate crisis. In China’s forests, he looks past the destruction of trees and asks why they are being cut in the first place, and who is paying the cost. Metals for iPhones and palm oil for processed foods are among the products that come straight out of South Asian and African emerging disease hot spots. “We turn a blind eye to the fact that our behavior is driving this,” he said. “We get cheap goods through Walmart, and then we pay for it forever through the rise in pandemics. It’s upside down.” Full Article
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