ease Six Charged in Scheme to Use Identities of Deceased People to Get Tax Refunds By www.justice.gov Published On :: Wed, 25 Jan 2012 16:14:50 EST A 10-count indictment was unsealed today charging six people with various offenses related to a scheme to defraud the Internal Revenue Service (IRS) of at least $1.7 million in fraudulently obtained tax returns, often filed in the names of recently deceased taxpayers, the Justice Department and IRS announced today. Full Article OPA Press Releases
ease U.S. Orders Pennylvania Diet Supplement Company to Cease Operations Pending Reinspection by FDA By www.justice.gov Published On :: Tue, 13 Mar 2012 16:18:09 EDT The United States has entered a consent decree against ATF Fitness Products Inc., Manufacturing ATF Dedicated Excellence Inc. (MADE), and the owner and president of both companies, James G. Vercellotti, the Justice Department announced today. Full Article OPA Press Releases
ease Six Plead Guilty in Ohio to Tax and Mail Fraud Conspiracies Involving I.D. Theft of Deceased By www.justice.gov Published On :: Tue, 13 Mar 2012 18:25:14 EDT Muaad Salem, Hanan Widdi, Najeh Widdi, Hazem Woodi, Daxesj Patel and Fahim Suleiman each entered guilty pleas before the Honorable James S. Gwin today to charges arising from a scheme to obtain false and fraudulent U.S. Treasury tax refund checks, the Justice Department, the U.S. Attorney’s Office for the Northern District of Ohio and the Internal Revenue Service (IRS) announced. Full Article OPA Press Releases
ease Department of Justice Releases Investigative Findings on the Walnut Grove Youth Correctional Facility in Mississippi By www.justice.gov Published On :: Wed, 21 Mar 2012 14:21:11 EDT Following a comprehensive investigation, the Justice Department announced today its findings that the state of Mississippi violated the constitutional rights of youth detained at the Walnut Grove Youth Correctional Facility. Full Article OPA Press Releases
ease Department of Justice Releases Investigative Findings on the Juvenile Court of Memphis and Shelby County, Tennessee By www.justice.gov Published On :: Thu, 26 Apr 2012 11:50:30 EDT Following a comprehensive investigation, the Justice Department today announced its findings regarding the Juvenile Court of Memphis and Shelby County (JCMSC), and the Shelby County Juvenile Detention Center in Tennessee. The Justice Department found that the juvenile court fails to provide constitutionally required due process to all children appearing for delinquency proceedings, that the court’s administration of juvenile justice discriminates against African-American children, and that its detention center violates the substantive due process rights of detained youth by not providing them with reasonably safe conditions of confinement. The investigation, opened in August 2009, was conducted under provision of the Violent Crime Control and Law Enforcement Act of 1994 and Title VI of the Civil Rights Act of 1964. Full Article OPA Press Releases
ease U.S. and State of Ohio Reach $5.5 Million Settlement for Damages from Hazardous Releases in Lower Ashtabula River and Harbor By www.justice.gov Published On :: Thu, 3 May 2012 14:53:23 EDT consent decree, valued at approximately $5.5 million, was filed today in the U.S. District Court for the Northern District of Ohio. Full Article OPA Press Releases
ease Justice Department Releases Final Rule to Prevent, Detect and Respond to Prison Rape By www.justice.gov Published On :: Thu, 17 May 2012 12:20:37 EDT The Justice Department today released a final rule to prevent, detect and respond to sexual abuse in confinement facilities, in accordance with the Prison Rape Elimination Act of 2003 (PREA). Full Article OPA Press Releases
ease U.S. and Canada Announce the Release of the Beyond the Border: Statement of Privacy Principles By www.justice.gov Published On :: Thu, 28 Jun 2012 16:19:43 EDT The United States and Canada today announced they are delivering on key commitments under the U.S.-Canada Beyond the Border Action Plan by releasing a joint Statement of Privacy Principles. Full Article OPA Press Releases
ease Justice Department Releases Investigative Findings Showing Constitutional Rights of Children in Mississippi Being Violated By www.justice.gov Published On :: Fri, 10 Aug 2012 12:17:00 EDT The Justice Department released a letter of findings today determining that the Lauderdale County Youth Court, the Meridian Police Department (MPD), and the Mississippi Division of Youth Services (DYS) are violating the constitutional rights of juveniles in Meridian, Miss. The department’s investigation found reasonable cause to believe that these agencies have violated the constitutional due process rights of children in the city of Meridian and the county of Lauderdale under the Fourth, Fifth, and Fourteenth Amendments of the U.S. Constitution. Full Article OPA Press Releases
ease Justice Department Releases Investigative Findings Showing Violation of Constitutional Rights in Kansas Correctional Facility By www.justice.gov Published On :: Thu, 6 Sep 2012 17:03:45 EDT Following a comprehensive investigation, the Justice Department today released its letter of findings determining that the Topeka Correctional Facility (TCF), an all-female facility in Topeka, Kan., under the jurisdiction of the Kansas Department of Corrections (KDOC), fails to protect women prisoners from harm due to sexual abuse and misconduct from correctional staff and other prisoners in violation of their constitutional rights. The Justice Department delivered a letter detailing the findings to Governor Samuel D. Brownback and Secretary of the KDOC Ray Roberts. Full Article OPA Press Releases
ease Justice Department Releases a Report on Accessibility of Federal Government Electronic and Information Technology By www.justice.gov Published On :: Wed, 12 Sep 2012 16:26:47 EDT The Justice Department announced the release of its “Section 508 report to the President and Congress: “Accessibility of Federal Electronic and Information Technology.” Full Article OPA Press Releases
ease Justice Department Releases Investigative Findings on the Alamance County, N.C., Sheriff’s Office By www.justice.gov Published On :: Tue, 18 Sep 2012 12:43:06 EDT Following a comprehensive investigation, the Justice Department announced today its findings that the Alamance County Sheriff’s Office (ACSO) in North Carolina, under the leadership of Sheriff Terry S. Johnson, engages in a pattern or practice of misconduct that violates the Constitution and federal law. The department conducted its investigation, which it opened on June 2, 2010, pursuant to the Violent Crime Control and Law Enforcement Act of 1994 and Title VI of the Civil Rights Act of 1964 (Title VI). Full Article OPA Press Releases
ease The Department of Justice and the Securities and Exchange Commission Release FCPA Resource Guide By www.justice.gov Published On :: Wed, 14 Nov 2012 10:15:12 EST The Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC) today released A Resource Guide to the U.S. Foreign Corrupt Practices Act (the Guide). The 120-page Guide provides a detailed analysis of the U.S. Foreign Corrupt Practices Act (FCPA) and closely examines the DOJ and SEC’s approach to FCPA enforcement. Full Article OPA Press Releases
ease Statement by Attorney General Eric Holder on the Release of the National Advisory Committee on Violence Against Women Recommendations By www.justice.gov Published On :: Fri, 30 Nov 2012 11:26:32 EST Attorney General Eric Holder issued the following statement today on the release of the recommendations by the National Advisory Committee on Violence Against Women. Full Article OPA Press Releases
ease Justice Department and Lesley University Sign Agreement to Ensure Meal Plan Is Inclusive of Students with Celiac Disease and Food Allergies By www.justice.gov Published On :: Thu, 20 Dec 2012 16:15:11 EST The Justice Department today announced an agreement with Lesley University in Cambridge, Mass., to ensure that students with celiac disease and other food allergies can fully and equally enjoy the university’s meal plan and food services in compliance with the Americans with Disabilities Act (ADA). Full Article OPA Press Releases
ease Ohio Federal Court Bars Appraiser of Historic-Preservation Easements By www.justice.gov Published On :: Wed, 13 Feb 2013 10:27:28 EST A federal court in Cleveland has barred MAI-designated real estate appraiser Michael Ehrmann and his firm, Jefferson & Lee Appraisals Inc., from preparing property appraisals for federal tax purposes. Full Article OPA Press Releases
ease Justice Department Releases Spanish Language Video About Discrimination in Employment Eligibility Verification By www.justice.gov Published On :: Wed, 20 Feb 2013 12:54:02 EST The Civil Rights Division of the Justice Department announced today the launch of its first Spanish-language educational video. The video was developed by the Office of Special Counsel for Immigration-Related Unfair Employment Practices to assist employers in avoiding charges of discrimination in the Employment Eligibility Verification Form I-9 process and to assist employees to be aware of their legal rights. Full Article OPA Press Releases
ease Settlement with Tyson Foods to Address Multiple Releases of Anhydrous Ammonia By www.justice.gov Published On :: Thu, 4 Apr 2013 17:38:47 EDT The U.S. Department of Justice and the U.S. Environmental Protection Agency (EPA) announced a Clean Air Act (CAA) settlement with Tyson Foods Inc. and several of its affiliate corporations to address threats of accidental chemical releases after anhydrous ammonia was released during incidents at facilities in Kansas, Missouri, Iowa and Nebraska, resulting in multiple injuries, property damage and one fatality. Full Article OPA Press Releases
ease Justice Department Releases Updated Protocol to Improve Standards for Responding to Rape and Sexual Assault By www.justice.gov Published On :: Wed, 24 Apr 2013 10:35:51 EDT Attorney General Eric Holder today announced a revised version of the National Protocol for Sexual Assault Medical Forensic Examinations (SAFE Protocol, 2d.) The SAFE Protocol is a voluntary best practices guide to conducting sexual assault medical forensic examinations protocols. Full Article OPA Press Releases
ease Acting Assistant Attorney General for the Office of Justice Programs Mary Lou Leary Speaks at the Release of the Framework of Vision 21: Transforming Victim Services Final Report By www.justice.gov Published On :: Wed, 24 Apr 2013 11:42:15 EDT "The goal of Vision 21 is to create a framework to address these enduring and emerging challenges – in short, to re-define the role of victim services in the 21st century," said Acting Assistant Attorney General Leary Full Article Speech
ease Departments of Justice and Housing and Urban Development Release New Guidance on “Design and Construction” Requirements Under the Fair Housing Act By www.justice.gov Published On :: Tue, 30 Apr 2013 15:09:00 EDT New guidance released today by the U.S. Department of Housing and Urban Development (HUD) and the U.S. Department of Justice reinforces the Fair Housing Act requirement that multifamily housing be designed and constructed so as to be accessible to persons with disabilities. Full Article OPA Press Releases
ease Department of Justice Releases Report to Congress on Indian Country Investigations and Prosecutions By www.justice.gov Published On :: Thu, 30 May 2013 11:13:02 EDT The Department of Justice released today a report to Congress entitled Indian Country Investigations and Prosecutions which provides a range of enforcement statistics required under the Tribal Law and Order Act of 2010. Full Article OPA Press Releases
ease Justice Department Releases Findings on the Antelope Valley Stations of the Los Angeles County Sheriff’s Department By www.justice.gov Published On :: Fri, 28 Jun 2013 15:17:36 EDT The Justice Department Civil Rights Division and Los Angeles County today announced that they have reached preliminary agreements to make broad changes to policing in the Antelope Valley and to the enforcement of the Housing Choice Voucher Program (commonly known as Section 8). Full Article OPA Press Releases
ease Justice Department Releases Investigative Findings on the City of Miami Police Department and Officer-involved Shootings By www.justice.gov Published On :: Tue, 9 Jul 2013 14:15:26 EDT Following a comprehensive investigation, the Justice Department today released its letter of findings determining that the city of Miami Police Department (MPD) has engaged in a pattern or practice of excessive use of force through officer-involved shootings in violation of the Fourth Amendment of the Constitution. Full Article OPA Press Releases
ease Justice Department Releases Educational Video About Discrimination in Employment Eligibility Verification By www.justice.gov Published On :: Thu, 11 Jul 2013 10:30:45 EDT The Justice Department announced today the launch of a new educational video to assist employers in avoiding charges of discrimination in the employment eligibility verification form I-9 process and in the use of E-Verify. Full Article OPA Press Releases
ease Attorney General Holder Meets with Mexican Attorney General About Mexico's Release of DEA Agent's Killer By www.justice.gov Published On :: Mon, 9 Sep 2013 17:31:16 EDT Attorney General Eric Holder met with Mexican Attorney General Jesús Murillo Karam today to discuss the release by the Mexican government of Rafael Caro Quintero, who was convicted of murdering Drug Enforcement Administration (DEA) Agent Enrique "Kiki" Camarena in February 1985. Full Article OPA Press Releases
ease Attorney General Eric Holder Releases Statement on the Washington Navy Yard Shooting By www.justice.gov Published On :: Mon, 16 Sep 2013 17:54:00 EDT The Attorney General issued the following statement today in the wake of the tragedy at the Washington Navy Yard. Full Article OPA Press Releases
ease Justice Department Releases Findings Showing That the Alabama Department of Corrections Fails to Protect Prisoners from Sexual Abuse and Sexual Harassment at the Julia Tutwiler Prison for Women By www.justice.gov Published On :: Wed, 22 Jan 2014 12:29:33 EST Today the Justice Department’s Civil Rights Division announced its letter of findings determining that prison officials at the Alabama Department of Corrections and the Julia Tutwiler Prison for Women violate women prisoners’ constitutional rights by failing to take reasonable steps to protect them from harm due to sexual abuse and sexual harassment caused by correctional staff. Full Article OPA Press Releases
ease Justice Department Releases New Planning Tool to Help Courts Provide Access to Limited English Proficient Individuals By www.justice.gov Published On :: Fri, 28 Feb 2014 15:50:49 EST Today, the Justice Department released a new tool to help state and local courts assess and improve their language assistance services for limited English proficient litigants, victims and witnesses who need access to court services. Full Article OPA Press Releases
ease In New Step to Fight Recidivism, Attorney General Holder Announces Justice Department to Require Federal Halfway Houses to Boost Treatment Services for Inmates Prior to Release By www.justice.gov Published On :: Mon, 24 Mar 2014 11:49:46 EDT In a new step to further the Justice Department’s efforts towards enhancing reentry among formerly incarcerated individuals, Attorney General Eric Holder announced Monday that the Bureau of Prisons (BOP) will impose new requirements on federal halfway houses that help inmates transition back into society. Full Article OPA Press Releases
ease Justice Department Releases Investigative Findings on Albuquerque Police Department By www.justice.gov Published On :: Thu, 10 Apr 2014 12:22:01 EDT Following a comprehensive investigation, today the Justice Department announced its findings that the Albuquerque Police Department has engaged in a pattern or practice of excessive force that violates the Constitution and federal law. Full Article OPA Press Releases
ease Environment and Natural Resources Division Releases FY 2013 Accomplishments Report By www.justice.gov Published On :: Tue, 22 Apr 2014 09:48:45 EDT The Justice Department’s Environment and Natural Resources Division (ENRD) today released its Fiscal Year (FY) 2013 Accomplishments Report detailing its work alongside other federal agencies. Full Article OPA Press Releases
ease Bureau of Justice Statistics Releases Tribal Crime Data Collection Activities, 2014 By www.justice.gov Published On :: Fri, 29 Aug 2014 12:25:31 EDT This fourth annual report to Congress describes efforts to collect and improve data on crime and justice in Indian country, as required by the Tribal Law and Order Act of 2010. The report details the number of tribal law enforcement agencies reporting crime data to the FBI’s Uniform Crime Reporting program. It describes BJS’s first National Survey of Tribal Court Systems which will collect data on tribal courts in the lower 48 states and Alaska covering 566 tribes Full Article OPA Press Releases
ease Justice Department Releases Best Practices Guide to Reform HIV-Specific Criminal Laws to Align with Scientifically-Supported Factors By www.justice.gov Published On :: Fri, 29 Aug 2014 12:44:20 EDT The Justice Department announced today that it has released a Best Practices Guide to Reform HIV-Specific Criminal Laws to Align with Scientifically-Supported Factors . This guide provides technical assistance regarding state laws that criminalize engaging in certain behaviors without disclosing known HIV-positive status Full Article OPA Press Releases
ease Department of Justice and the International Association of Chiefs of Police Release Groundbreaking Model Policy By www.justice.gov Published On :: Thu, 28 Aug 2014 16:15:59 EDT The Department of Justice’s Office of Justice Programs (OJP), in partnership with the International Association of Chiefs of Police (IACP), today released a seminal model policy regarding police interaction with children who are impacted when a parent is arrested and law enforcement carries out its investigative and arrest responsibilities. Reflecting the collective input of a wide range of subject-matter experts and stakeholders, and understanding that interactions between children and law enforcement create lasting impressions, the resulting model policy, Safeguarding Children of Arrested Parents , provides strategies for law enforcement to improve their procedures and positively impact the communities they serve Full Article OPA Press Releases
ease McKesson Corp. to Pay $18 Million to Resolve False Claims Allegations Related to Shipping Services Provided Under Centers for Disease Control Vaccine Distribution Contract By www.justice.gov Published On :: Thu, 28 Aug 2014 14:59:47 EDT McKesson Corporation has agreed to pay $18 million to resolve allegations that it improperly set temperature monitors used in shipping vaccines under its contract with the Centers for Disease Control and Prevention (CDC), the Justice Department announced today. McKesson is a pharmaceutical distributor with corporate headquarters in San Francisco Full Article OPA Press Releases
ease The following joint statement was released Friday by FBI Special Agent in Charge William P. Woods, U.S. Attorney for the Eastern District of Missouri Richard G. Callahan and Acting Assistant Attorney General for the Civil Rights Division Molly Moran By www.justice.gov Published On :: Thu, 28 Aug 2014 14:18:32 EDT The former chief executive officer of Hanover Corporation was sentenced today to serve 14 years in prison, to be followed by three years of supervised release and ordered to pay $14,784,983.75 in restitution for orchestrating an $18 million Ponzi scheme Full Article OPA Press Releases
ease Department of Justice Releases Second Report to Congress on Indian Country Investigations and Prosecutions By www.justice.gov Published On :: Thu, 28 Aug 2014 13:17:50 EDT The Department of Justice released today its second report to Congress entitled Indian Country Investigations and Prosecutions, which provides a range of enforcement statistics required under the Tribal Law and Order Act of 2010, as well as information about the progress of the Attorney General’s initiatives to reduce violent crime and strengthen tribal justice systems Full Article OPA Press Releases
ease ARDS In COVID-19 Battle, AKBA's Kidney Disease Drug Hits Goals, VAPO On A Roll By www.rttnews.com Published On :: Wed, 06 May 2020 05:15:35 GMT Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results. Full Article
ease ABAC Release: Achieving Integration and Inclusion in the Age of Disruption By www.apec.org Published On :: Tue, 18 Feb 2020 13:50:00 +0800 Business leaders from around the Asia-Pacific met in Sydney last week to discuss the year ahead Full Article
ease Pfizer’s $308m buy-in for Lyme disease vaccine By www.biopharma-reporter.com Published On :: Mon, 04 May 2020 14:56:00 +0100 Pfizer partners with Valneva to progress Phase II-stage vaccine candidate for Lyme disease. Full Article Bio Developments
ease 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
ease 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
ease 2020 CDER Guidance Agenda Released By regulatoryrx.blogspot.com Published On :: Mon, 03 Feb 2020 14:54:00 +0000 UPDATE: The guidance mentioned below was released. Here's the link.The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers Also notable is that no other advertising or promotional guidances are listed. The draft guidance on presenting risk information turned 10 years old last year. It seemed ripe for an update and perhaps even finalization. That seemed even more likely in the context of OPDP's study of the so-called one-click rule. That study was first announced in 2017. There's no update on the FDA website about the study, but I expected it to be completed last year.FDA's social science research has clearly been influencing recent guidances, so I assumed (and continue to assume) that FDA would want to update the risk presentation guidance in light of its most recent research about presenting risks, including the one-click study. Apparently, we'll have to keep waiting.BTW, for those interested in the topic of biosimilar promotion, the Drug Information Association's Advertising & Promotion Regulatory Affairs Conference will have a session covering this topic. Full disclosure: I sit on the programming committee for the conference and will be leading the medical device primer the day before the full conference kicks off. Full Article biosimilars CDER DIA Guidance Guidance Agenda OPDP
ease Pharmacies' dispensing increases by up to a third as a result of COVID-19, survey finds By feeds.pjonline.com Published On :: Tue, 21 Apr 2020 15:22 GMT Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association. To read the whole article click on the headline Full Article
ease Myocardial injury associated with increased risk of death from COVID-19, research suggests By feeds.pjonline.com Published On :: Thu, 23 Apr 2020 11:37 GMT The development of myocardial injury in COVID-19 patients is associated with an increased risk of death, researchers have found. To read the whole article click on the headline Full Article
ease Care home pharmacists redeployed, despite COVID-19 palliative care increase By feeds.pjonline.com Published On :: Fri, 24 Apr 2020 10:22 GMT Exclusive: Pharmacy staff in care homes are being redeployed to cover other roles during the COVID-19 pandemic, even though demands on care homes are increasing rapidly, The Pharmaceutical Journal has learnt. To read the whole article click on the headline Full Article
ease Emergency Relief Package Yields Increased FDA Funding, OTC Revisions By cohealthcom.org Published On :: Mon, 30 Mar 2020 16:04:19 +0000 March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […] Full Article Legislative Congress Coronavirus COVID-19 emergency relief fda funding Jon Bigelow OTC regulation OTC user fees President Trump sunscreen
ease Casein-encapsulated calcium eases GI concerns, study finds By www.nutraingredients-latam.com Published On :: Wed, 06 May 2020 15:31:00 +0100 Researchers working with a group of postmenopausal women found that a technology using casein to encapsulate calcium nanoparticles reduced GI issues compared with more conventional calcium carbonate or calcium citrate supplements. Full Article Research
ease Blood: Underappreciated Resource in the Health/Disease? By thenextelement.wordpress.com Published On :: Tue, 05 May 2015 22:48:50 +0000 Alternative title: Pitching a VC on Disruption of Blood Testing You may have seen some recent editorials about the necessary frequency of blood tests for healthy individuals, many of them prompted by a series of tweets from Mark Cuban: Although there are certainly potential dangers in expecting any and all test results to be immediatelyRead More Full Article Uncategorized biotech biotechnology blood cancer drug development immunooncology labcorp oncology theranos