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DOJ Secures Lengthy Sentence For Pennsylvania Man For Violent Robbery Of Little Italy Resident

A Pennsylvania man has been sentenced to more than a decade in prison for violent assault and robbery. On August 25, 2023, Zykeem Fields, 23, was sentenced to 15 years in prison, followed by probation, by a Superior Court judge. Fields, who lived part-time in Wilmington, pleaded guilty to felony charges of Assault 1st Degree and Robbery 1st Degree following a brutal attack in 2022.   On September 28, 2022, Fields followed […]



  • Department of Justice Press Releases

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DOJ Secures Decade In Prison For Delaware Man In Fatal Shooting

A Wilmington man has been sentenced to prison time for a fatal shooting. On September 1, 2023, Dean Sutton Jr. was sentenced to ten years in prison by a Superior Court Judge for convictions of Manslaughter and Reckless Endangering 1st Degree following an investigation into a 2021 shooting. At trial, Sutton claimed to have acted […]



  • Department of Justice Press Releases

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DOJ Secures Life Sentence For Serial Stalker

A New Castle man has been sentenced to life in prison following convictions in two domestic violence cases. On September 22, David Jewell, 47, was declared a habitual offender and sentenced to life in prison for convictions of felony Stalking, Harassment, and 24 counts of Terroristic Threatening, following an investigation into hundreds of violent phone calls and messages targeting two victims, one of whom was a […]



  • Department of Justice Press Releases

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DOJ Secures Guilty Plea For A Violent Gun Offender 

Plea agreement brings lengthy prison time, resolves five pending cases  On October 2, 34-year-old Timothy Thomas of Wilmington pleaded guilty to Murder 2nd Degree and Possession of a Firearm by a Person Prohibited in New Castle County Superior Court following an investigation into the July 2020 shooting of Andre Hickson. “I am grateful to our prosecutors and the Wilmington Police Department for their […]



  • Department of Justice
  • Department of Justice Press Releases
  • News

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Prosecutors Secure Convictions Against Serial Child Abusers

The Delaware Department of Justice has secured multiple felony convictions against a Kent County couple charged with the serial abuse and torture of their children, Attorney General Kathy Jennings announced Wednesday. “These are the cases that keep us up at night,” said Attorney General Jennings. “The pain that these children endured — and that it […]



  • Department of Justice
  • Department of Justice Press Releases
  • News

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DOJ Secures Guilty Plea For Claymont Man In Brutal 2022 Murder Case

A Claymont man has pleaded guilty to several charges in the 2022 murder of Kevin Goodson, which means that all three men responsible for the murder are convicted and face up to life in prison. On October 10, 21-year-old Justin Locke pled guilty to Murder 2nd Degree, Possession of a Firearm During the Commission of a Felony, Conspiracy 1st Degree and Kidnapping 1st Degree in New […]



  • Department of Justice Press Releases

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Attorney General Jennings Secures Restitution And Governance Improvements For Residents Of Noble’s Pond

Attorney General Kathy Jennings announced today that the Department of Justice has settled its lawsuit against a developer for allegedly having misled residents at Noble’s Pond, a 55+ community outside Dover, Delaware and will begin making payments to residents.  The Department’s complaint, filed in 2019, included charges that Regal Builders, LLC, its president, and related entities, violated Delaware law by […]



  • Department of Justice Press Releases

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DOJ, Elsmere PD Secure Delaware’s First Ever Forced Labor Conviction

An Elsmere man will serve a lengthy prison sentence after pleading guilty to multiple felonies, including Delaware’s first conviction under a Forced Labor statute originally passed in 2014. On October 13, Martin Ortiz-Lozano, 34, was sentenced to fifteen years in prison after pleading guilty to two counts of Child Abuse in the First Degree and one […]



  • Department of Justice
  • Department of Justice Press Releases
  • News

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DOJ secures lengthy sentence for Wilmington man in fatal shooting incident 

On January 5, Timothy Thomas, 34, of Newark was sentenced to 25 years in prison for convictions of Murder 2nd Degree and Possession of a Firearm by a Person Prohibited. Thomas previously submitted a guilty plea in October following an investigation into the shooting of Andre Hickson, 40, on July 6, 2020. “When you commit […]



  • Department of Justice
  • Department of Justice Press Releases
  • News

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DOJ secures felony conviction in first of several cases related to abuses of the 2022 Delaware Relief Rebate Program 

The Delaware Department of Justice secured a felony conviction in the first of several pending cases stemming from an ongoing investigation by the Delaware Division of Revenue and the Department of Justice into fraud related to the 2022 Delaware Relief Rebate Program. That program provided Delaware residents with a one-time $300.00 check and was intended […]



  • Department of Justice
  • Department of Justice Press Releases
  • News

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DOJ secures guilty pleas, prison time in fatal shooting case

Two people have pleaded guilty in relation to the assault and fatal shooting of 19-year-old Za’Quan Blackwell. On February 2, Ah’Kee Flonnory of Wilmington pleaded guilty to Manslaughter, and Possession of a Firearm During the Commission of a Felony; Armani Rogers, 20, of New Castle pleaded guilty to Assault 2nd Degree.  “This was a tragic loss […]



  • Department of Justice Press Releases

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DOJ secures over a dozen convictions for violent gun offender following nine-month manhunt

A Wilmington man has been convicted of several felonies, including three separate counts of Attempted Murder, Attorney General Kathy Jennings announced Wednesday.   “An extremely violent gun offender will spend the rest of his life in prison because of excellent collaboration between Wilmington PD, prosecutors, and federal law enforcement,” said Attorney General Kathy Jennings. “These cases […]



  • Department of Justice Press Releases

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DOJ secures over seven life sentences, habitual offender status for Keith Gibson after violent killing spree

Attorney General Kathy Jennings announced Wednesday that 41-year-old Keith Gibson was declared a Habitual Offender and sentenced in New Castle County Superior Court to seven life terms, plus 296 years in prison for 22 convictions, including four counts of murder, relating to a brutal crime spree in the summer of 2021 that claimed the lives […]



  • Department of Justice Press Releases

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Prosecutors secure conviction against Jordan Ellerbe’s murderer

A Wilmington man has been convicted of the January 2015 murder of 16-year-old Jordan Ellerbe. Oliver “Butter” Henry, 25, has pleaded guilty to Murder 2nd Degree and faces a minimum 15 years in prison.  Ellerbe’s murder ignited a rapidly accelerating feud between two rival gangs, Shoot to Kill and Only My Brothers. In the months and […]



  • Department of Justice Press Releases

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DOJ secures guilty plea for violent gun offender in cold case murder

A Wilmington man has pled guilty to charges stemming from the 2018 murder of Richard Young. On April 22, 24-year-old Nasir Anderson pled guilty to Murder Second Degree, Possession of a Firearm During Commission of a Felony, Robbery First Degree and Conspiracy Second Degree in New Castle County Superior Court. The plea follows a six-year […]



  • Department of Justice Press Releases

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DOJ secures a murder conviction for violent gun offender

A Wilmington man has pled guilty to murder charges stemming from the 2022 killing of Bruce Wright. On April 22, 2024, Marcus Bailey, 20, pled guilty to Murder Second Degree and Possession of a Firearm During the Commission of a Felony in Kent County Superior Court. The plea follows an investigation into the shooting of […]



  • Department of Justice Press Releases

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Delaware Sees Increase in Potbellied Pigs Running At Large, Owners Reminded to Secure Animals

Delaware has been experiencing a significant increase in potbellied pigs running at large in residential and rural areas, including on state lands. Running at large, these pigs pose a nuisance to landowners, increase the threat of establishing feral pig populations, damage natural resources, and risk carrying endemic diseases that can spread to both people and animals.




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Auditor McGuiness: Time is Now to Secure Provider Status for Delaware’s Pharmacists

DOVER, Del. – State Auditor Kathy McGuiness today released a new special report that reviews federal and state legislation concerning pharmacists’ provider status and shows that Delaware is one of only 13 states yet to pass reimbursement and provider status legislation. “Pharmacists have been long on the frontlines of healthcare, which has become more obvious […]



  • Auditor of Accounts
  • Delaware Health and Social Services
  • Former Auditor of Accounts - Kathy McGuiness

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Delaware Division of the Arts Secures National Funding for Delaware Creative Aging Program

Wilmington, Del. (August 3, 2023) – The Delaware Division of the Arts recently secured new funding from a national grant program to advance creative aging programs for adults aged 55+ in Delaware. Building upon the transformative success of the Leveraging State Investments in Creative Aging program, which catalyzed arts learning opportunities for adults aged 55+ […]



  • Delaware Division of the Arts
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  • Governor John Carney
  • Kent County
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  • News
  • Office of the Governor
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  • Sussex County
  • "Delaware Division of the Arts"
  • Arts Enrichment Programs
  • Delaware Creative Aging
  • Delaware State Libraries
  • E.A. Michelson Philanthropy
  • Mental Health in the Arts
  • NASAA
  • National Assembly of State Arts Agencies
  • National Funding
  • Older Adults in Delaware
  • Programs for 55+ Adults
  • Programs for Seniors

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AG Jennings Secures Over $270 Million Settlement in Principle with Amneal Pharmaceuticals for Role in Opioid Crisis

Delaware Attorney General Kathy Jennings today announced a multistate settlement in principle with opioid manufacturer Amneal Pharmaceuticals (Amneal) for its role in fueling the nationwide epidemic of opioid addictions and overdoses. Amneal produces several generic opioid products and was one of the largest manufacturers of opioids from 2006 to 2019, selling nearly nine billion pills. […]



  • Department of Justice Press Releases

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Cold case cracked as prosecutors secure murder plea

A Wilmington man has been convicted in a nearly four-year-long cold case. On May 15, Dashawn Daley, 29, of Wilmington pleaded guilty to Murder 2nd Degree, and Possession of a Firearm During the Commission of a Felony. This conviction follows an investigation into the fatal 2019 shooting of then 29-year-old Hakeem Smalls. “I am grateful […]



  • Department of Justice
  • Department of Justice Press Releases
  • News

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DOJ secures conviction in violent gun case

A Wilmington man has been convicted of multiple felonies, including Muder 1st Degree, for the 2021 killing of Tyaire Anderson.     On  June 10, Tyrell Reid, 33, was convicted in New Castle County Superior Court of Murder 1st Degree, Assault First Degree, Attempted Assault 1st Degree, Possession of a Firearm by a Person Prohibited, […]



  • Department of Justice Press Releases

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DOJ secures lengthy prison sentence for violent gun offender

   A Maryland man has been sentenced to more than three decades in prison for the fatal shooting of Charles “Jaimie” Kupidlowski in 2023.     On June 17, Steven M. Smith of Centreville, MD, pleaded guilty in Kent County Superior Court to Murder 2nd Degree and Possession of a Firearm During the Commission of a […]



  • Department of Justice Press Releases

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DOJ secures significant prison time for habitual shoplifter turned robber

The Delaware Department of Justice has secured five years in prison followed by probation for a Wilmington woman who stole thousands of dollars worth of goods from Delaware retail chains between 2023 and 2024.      On July 10, Jasmine Williams, 36, was sentenced to five years of Level V prison followed by one year of […]



  • Department of Justice Press Releases

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DOJ secures life plus ten years for deadly gun offender

A Wilmington man has been sentenced to life plus ten years in prison for convictions stemming from the fatal shooting of Thaddeus Blackman in 2023.     On August 16, Kevin Berry, 34, was sentenced to life plus an additional 10 years in prison for convictions of Murder First Degree, Possession of a Firearm During […]



  • Department of Justice Press Releases

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DOJ secures lengthy prison sentences for individuals involved in brutal murder

Two individuals have been sentenced in connection with a 2020 missing person investigation turned murder case that crossed state lines. On August 28, Leonard Church of Henderson, Maryland and Esther Wright AKA Esther Hurtado-Chavez, of Clayton, were sentenced in Kent County Superior Court. Church, 43, was sentenced to 90 years of prison, suspended after 65 […]



  • Department of Justice Press Releases

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DOJ secures prison time for former trooper

A Delaware State Trooper has been sentenced for multiple felony convictions, including Delaware’s first-ever use of a new Deprivation of Civil Rights statute passed by lawmakers last year, for brutally assaulting a 15-year-old victim and fracturing his orbital socket in response to an apparent prank. On October 15, 2024, Walters, 30, was sentenced to one […]



  • Department of Justice Press Releases

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DOJ secures more than two decades of prison time in cold case murder

A Wilmington man has been sentenced to 23 years for convictions stemming from the 2018 murder of Richard Young. On October 18, Nasir Anderson, 24, was sentenced to 102 years in prison, suspended after 23 years followed by descending levels of probation for convictions of Murder Second Degree, Possession of a Firearm During the Commission of a […]



  • Department of Justice Press Releases

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DOJ secures conviction in the killing of Cynthia Amalfitano 

A Wilmington man has been convicted in the 2023 murder of Cynthia Amalfitano. On November 1, 2024, Stephen Heck, 67, was convicted of Murder 1st Degree by a New Castle County Superior Court jury. The conviction follows an investigation into the disappearance and death of then 64-year-old Cynthia Amalfitano, Heck’s former partner, whose body was discovered in […]



  • Department of Justice Press Releases

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O2Cure Hulk Review

Read the in depth Review of O2Cure Hulk Air Purifier. Know detailed info about O2Cure Hulk configuration, design and performance quality along with pros & cons, Digit rating, verdict based on user opinions/feedback.




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Cape Town Secures Historic Bid to Host WorldPride 2028

[allAfrica] We are excited to share the momentous news that Cape Town Pride has officially won the bid to host WorldPride 2028. This significant event is a global celebration of LGBTQ+ pride and rights, marking a pivotal milestone not only for the LGBTQ+ community in the city but also for the entire African continent. This victory positions Cape Town as a leading symbol of inclusivity and diversity, showcasing its commitment to advancing a welcoming environment for all.




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Where Are We in the Search for an HIV Cure?

[spotlight] Highly effective treatments for HIV have existed since the mid-1990s. But while these treatments keep people healthy, we do not yet have a safe and scalable way to completely rid the body of the virus. In this Spotlight special briefing, Elri Voigt takes stock of where we are in the decades-long search for an HIV cure.




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Lab Confidential: Japan Research Keeps Healthcare Data Secure

Established 77 years ago, Mitsui & Co stays vibrant by building businesses and ecosystems with new technologies like generative AI and confidential computing. Digital transformation takes many forms at the Tokyo-based conglomerate with 16 divisions. In one case, it’s an autonomous trucking service, in another it’s a geospatial analysis platform. Mitsui even collaborates with a Read Article




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Palau’s president secures 2nd term amid attempt to navigate US-China competition

Taipei, Taiwan — Palau’s President Surangel Whipps Jr. has secured another term in office after defeating former President Tommy Remengesau Jr. in its Nov. 5 election that was closely monitored. Palau sits on the front line of competition for geopolitical influence between the United States and China in the Pacific Ocean. Analysts say the outcome shows more Palauan voters support Whipps’ policy agenda, which includes tax reforms and deeper engagement with the United States. “It seems Palau’s closer relationship with the United States under Whipps Jr.’s leadership makes sense for the majority of Palauans,” said Henryk Szadziewski, an expert on Pacific affairs at the University of Hawaii at Manoa. While election authorities still haven’t finished counting absentee ballots, Whipps has won the vote with one of the biggest margins in Palau’s electoral history, 57.5%. Remengesau, who is Whipps’ brother-in-law, took 41.3%. Whipps thanked supporters for allowing him to continue “building on the progress” that his administration has achieved over the last four years. “Your decision to grant me a second term as president is a responsibility I hold with the utmost respect,” he said in a statement shared with VOA on Monday. The president can only have two consecutive four-year terms and must step down after that, but he can run again after a four-year gap in between. Remengesau has served a total of four terms already. Separately, the spokesperson for Palau’s election commission told Radio New Zealand the following day that it was “highly unlikely” that Whipps would lose the election. Meanwhile, in a concession speech broadcast by a local radio station, the Palau Wave Productions, on November 7, Remengesau said the election is finished and the Palauan people have “spoken through a peaceful and free election.” Palau has a population of around 20,000 people and is situated around 890 kilometers (550 miles) east of the Philippines. It is one of three Pacific Island countries that receive significant economic support from the U.S. under agreements known as the Compacts of Free Association, or COFA. Under the accords, the U.S. provides economic aid worth billions of dollars, while Palau, the Marshall Islands, and the Federated States of Micronesia give the U.S. exclusive military access to their land, water and airspace, as well as the right to deny China access to their ports and territorial waters. In September, U.S. lawmakers passed funding for key provisions in COFA for Palau. The U.S. military is also helping to repair a runway on a World War II-era Japanese airfield on the island of Peleliu and installing two radar systems on Palau. Experts say they expect Palau to keep deepening ties with the U.S. during Whipps’ second term and relevant efforts will likely include increasing the frequency of U.S. military visits and enhancing connectivity with Palau. “There’s going to be a much stronger U.S. presence in terms of military visits, joint actions to combat transnational crime and illegal fishing, and boost transport and digital connectivity,” Meg Keen, a senior fellow at the Lowy Institute in Australia, told VOA by phone. During his first term, Whipps repeatedly said “presence is deterrence,” referring to the increased U.S. military presence in Palau, and characterized the Pacific island country as “part of the U.S. homeland” when it comes to security. In an interview with VOA last month, Whipps said U.S. protection plays a key role in safeguarding Palau’s territorial integrity. “Since Palau is small, having the protection of the United States is important because we see what’s happening now in the South China Sea between the Philippines and China,” he said during an interview at his office in Koror, Palau. Since 2023, the Chinese and Philippine coast guards have repeatedly confronted each other at several disputed shoals that both sides claim to be their territories. While Beijing views almost the entire South China Sea as its territorial water, a 2016 ruling by an international arbitration court found that most Chinese claims in the South China Sea were invalid. Beijing refuses to abide by the ruling. While many Palauans support the Whipps administration’s efforts to deepen security ties with the U.S., some political observers say some Palauans are still concerned about the negative impacts associated with the increased U.S. military presence across the Pacific island country. “Some Palauan people hold this apprehensiveness about the implication of increased U.S. military presence in Palau because they rarely saw U.S. soldiers in military uniforms in the past,” Kambes Kesolei, editor of one of Palau’s main newspapers, Tia Belau, told VOA by phone. “Some Palauans wonder what they can do to prevent Palau from becoming over-militarized,” he added. In addition to deepening ties with the U.S., some analysts say Palau will maintain its diplomatic ties with Taiwan, which could lead to “increased coercive pressure” from China. Beijing considers Taiwan part of its territory and has repeatedly vowed to reunite with the island, by force if necessary. “I expect ties between Palau and Taiwan to remain robust but increasing coercive pressure from the People’s Republic of China, [PRC,] may increase risks for Palau, which will need strong support from the U.S. and like-minded partners to maintain resiliency against PRC coercion,” Parker Novak, a nonresident fellow at the Atlantic Council's Global China Hub, told VOA in a written response. Whipps has accused China of weaponizing tourism against Palau and posing a wide range of threats to the Pacific island country’s national security, including cyberattacks and illegal incursion of Palau’s territorial water by Chinese vessels. “In 2015 and 2016, tourism numbers from China went through the roof, which helped Palau’s economy grow 30%, but since Palau never switched diplomatic recognition [from Taiwan] to China, that number just basically collapsed in the following years,” Whipps told VOA. In response to questions about Whipps’ claim that China has pressured Palau to sever diplomatic ties with Taiwan, Chinese foreign ministry spokesperson Mao Ning said during a regular press conference on November 4 that only a small number of countries, including Palau, still maintain diplomatic relations with Taiwan. “China urges these countries to fulfill their obligations under international law, stand on the right side of history, and make right decisions that truly serve their fundamental and long-term interests at an early date,” she said. While Whipps is likely to remain critical of China’s attempt to coerce Palau, Keen in Australia said the Palauan president is not going to completely “shut the door for China.” “He is very much wary of how China has used land and tourism to build pressure, but if the investment is in the national interests of Palau, he is willing to consider,” she told VOA.




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Asialink Promoting Small and Medium-Sized Enterprise Financing through Secured Vehicle Lending Project




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Why the words we use in physics obscure the true nature of reality

Simple words like "force" and "particle" can mislead us as to what reality is actually like. Physicist Matt Strassler unpacks how to see things more clearly




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Why the words we use in physics obscure the true nature of reality

Simple words like "force" and "particle" can mislead us as to what reality is actually like. Physicist Matt Strassler unpacks how to see things more clearly




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Calcium Plus Vitamin D Won't Cure Joint Pain, Study Finds

Title: Calcium Plus Vitamin D Won't Cure Joint Pain, Study Finds
Category: Health News
Created: 8/23/2013 2:35:00 PM
Last Editorial Review: 8/26/2013 12:00:00 AM




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Emma Raducanu adds event to schedule after Wimbledon talks as financial boost secured



Emma Raducanu struck a deal to return to one of her favourite tournaments.




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America Cured of the Woke Mind Virus

They were the ten words that sealed the comeback deal for Donald Trump.




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How VPNs shield your identity and secure your financial transactions from theft

A virtual private network is a service that encrypts your internet connection, ensuring your online activity remains private and secure.



  • 84af7ed4-6441-5599-8486-c667456675f6
  • fnc
  • Fox News
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The Best Gel Nail Kits for At-Home Manicures

Due for a mani or pedi? No need for a salon when you have one of these DIY gel nail kits.

[[ This is a content summary only. Visit my website for full links, other content, and more! ]]




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Everything You Need for a Salon Pedicure at Home

Yes, you can nail your own pedicure! But you'll need more than just nail varnish and toenail clippers.

[[ This is a content summary only. Visit my website for full links, other content, and more! ]]




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Freeland says Canada's borders are 'safe and secure' following Trump's election win

Deputy Prime Minister Chrystia Freeland is reassuring Canadians as officials worry president-elect Donald Trump’s promise to deport millions of undocumented immigrants could send them northward.




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Voting Has Never Been More Secure Than It Is Right Now

Efficient machines, paper ballots and human checks make the U.S. voting system robust




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No, CRISPR Is Not Going To ‘Cure’ Heart Disease

No, CRISPR gene editing technology is not going to “cure” heart disease. But a New York Times story by Gina Kolata on an extremely early study in animals prominently plays up just this extremely unlikely claim. The Times story is based on a press release issued by Verve Therapeutics, a new biotechnology company founded by Sekar Kathiresan, an influential cardiologist and genomic...

Click here to continue reading...




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Waiver of Informed Consent - proposed changes in the 21st Century Cures Act

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21st Century Cures Act:


In another tweet, he suggests that the act will "decimate" informed consent in drug trials. Subsequent responses and retweets  did nothing to clarify the situation, and if anything tended to spread, rather than address, Feuerstein's confusion.

Below is a quick recap of the current regulatory context and a real-life example of where the new wording may be helpful. In short, though, I think it's safe to say:


  1. Waiving informed consent is not new; it's already permitted under current regs
  2. The standards for obtaining a waiver of consent are stringent
  3. They may, in fact, be too stringent in a small number of situations
  4. The act may, in fact, be helpful in those situations
  5. Feuerstein may, in fact, need to chill out a little bit


(For the purposes of this discussion, I’m talking about drug trials, but I believe the device trial situation is parallel.)

Section 505(i) - the section this act proposes to amend - instructs the Secretary of Health and Human Services to propagate rules regarding clinical research. Subsection 4 addresses informed consent:

…the manufacturer, or the sponsor of the investigation, require[e] that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings.

[emphasis  mine]

Note that this section already recognizes situations where informed consent may be waived for practical or ethical reasons.

These rules were in fact promulgated under 45 CFR part 46, section 116. The relevant bit – as far as this conversation goes – regards circumstances under which informed consent might be fully or partially waived. Specifically, there are 4 criteria, all of which need to be met:

 (1) The research involves no more than minimal risk to the subjects;
 (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
 (3) The research could not practicably be carried out without the waiver or alteration; and
 (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In practice, this is an especially difficult set of criteria to meet for most studies. Criterion (1) rules out most “conventional” clinical trials, because the hallmarks of those trials (use of an investigational medicine, randomization of treatment, blinding of treatment allocation) are all deemed to be more than “minimal risk”. That leaves observational studies – but even many of these cannot clear the bar of criterion (3).

That word “practicably” is a doozy.

Here’s an all-too-real example from recent personal experience. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure. It seems – but there is little hard data – that a lot of physicians do not strictly follow guidelines on when to perform the procedure. So we devise a study: whenever the procedure is performed, we ask the physician to complete a quick form categorizing why they made their decision. We also ask him or her to transcribe a few pieces of data from the patient chart.

Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial.

It’s a minimal risk trial, definitely: the trial doesn’t dictate at all what the doctor should do, it just asks him or her to record what they did and why, and supply a bit of medical context for the decision. All told, we estimated 15 minutes of physician time to complete the form.

The IRB monitoring the trial, however, denied our request for a waiver of informed consent, since it was “practicable” (not easy, but possible) to obtain informed consent from the patient.  Informed consent – even with a slimmed-down form – was going to take a minimum of 30 minutes, so the length of the physician’s involvement tripled. In addition, many physicians opted out of the trial because they felt that the informed consent process added unnecessary anxiety and alarm for their patients, and provided no corresponding benefit.

The end result was not surprising: the budget for the trial more than doubled, and enrollment was far below expectations.

Which leads to two questions:

1.       Did the informed consent appreciably help a single patient in the trial? Very arguably, no. Consenting to being “in” the trial made zero difference in the patients’ care, added time to their stay in the clinic, and possibly added to their anxiety.
2.       Was less knowledge collected as a result? Absolutely, yes. The sponsor could have run two studies for the same cost. Instead, they ultimately reduced the power of the trial in order to cut losses.


Bottom line, it appears that the modifications proposed in the 21st Century Cures Act really only targets trials like the one in the example. The language clearly retains criteria 1 and 2 of the current HHS regs, which are the most important from a patient safety perspective, but cuts down the “practicability” requirement, potentially permitting high quality studies to be run with less time and cost.

Ultimately, it looks like a very small, but positive, change to the current rules.

The rest of the act appears to be a mash-up of some very good and some very bad (or at least not fully thought out) ideas. However, this clause should not be cause for alarm.




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Fort Health Secures $5.5M to Expand Access to Integrated Pediatric Mental Health Care

Fort Health’s $5.5 million in funding was led by Twelve Below and Vanterra and included participation from Redesign Health, Blue Venture Fund and True Wealth Ventures.

The post Fort Health Secures $5.5M to Expand Access to Integrated Pediatric Mental Health Care appeared first on MedCity News.