The NRL is committed to resuming the premiership season on May 28, but the New Zealand-based Warriors claim they have been left in the dark about the league's plans for their move back to Australia.

The consensus across football and netball clubs in the west and north-west of Victoria is the season should only start if fans are allowed to attend games.

Netflix's new documentary, "Becoming," a companion to Michelle Obama's memoir of the same name, is unlikely to change one's view of its subject.

Adele's celebratory Instagram spurred compliments and criticism that are just as sexist as Donald Trump's comments about Donna Reed.

Amy Jo Burns' novel, "Shiner," illuminates an Appalachia whose men "pray for God to show Himself while our wives wash their husbands' underpants."

Coronavirus muted the hype of Microsoft's Xbox Series X reveal. But there was "Assassin's Creed Valhalla" excitement and a "Madden NFL 21" end run.

The Hits Radio host is feeling better than ever

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MedTech Europe has issued a statement welcoming the delay for enforcing the European Medical Devices Regulation (EU MDR), and asking for similar action for the In Vitro Diagnostic Regulation (IVDR).

BIO’s “What Every State Should Know About Bayh-Dole” Webinar The Biotechnology Industry Organization (BIO) recently hosted a webinar entitled: “What Every State Should Know About Bayh-Dole: Leveraging University Research to Create Jobs and Spur Economic Development Benefits.” The Bayh-Dole Act, enacted in 1980, placed patent ownership of federally funded research at universities in the hands […]

I’m an astrophysicist, but that doesn’t mean I have a motivation to debunk them

-- Read more on ScientificAmerican.com

They don’t stand on one leg around just anybody but often prefer certain members of the flock.

-- Read more on ScientificAmerican.com

Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of...

Brooke E. Reyna, 28, of Barrington, N.H., pleaded guilty before U.S. District Judge Joseph N. Laplante in U.S. District Court for the District of New Hampshire to making false statements.

Former Chicago Police Department Commander Jon Burge, 63, of Apollo Beach, Fla., was sentenced today to 54 months in prison followed by three years of supervised release for lying in a deposition in a civil case about torture and abuse of suspects by Chicago Police Department officers.

A federal jury in Wilkes-Barre, Pa., has convicted Matthew Nestor and William Moyer of falsifying information related to the investigation into the beating death of Luis Ramirez.

"Boundless, too, are the opportunities now before us. So, today, as we look toward the future, we will take action in four key areas to fulfill one core mission: protecting the American people. These priorities will allow us to build on the record of success that we’ve established, and they will guide our future efforts."

The Justice Department announced that Matthew Nestor and William Moyer were sentenced today for falsifying information related to the investigation into the beating death of Luis Ramirez.

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.

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.

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.

The Justice Department, along with federal and state partners, today announced a $13 billion settlement with JPMorgan - the largest settlement with a single entity in American history - to resolve federal and state civil claims arising out of the packaging, marketing, sale and issuance of residential mortgage-backed securities (RMBS) by JPMorgan, Bear Stearns and Washington Mutual prior to Jan. 1, 2009. As part of the settlement, JPMorgan acknowledged it made serious misrepresentations to the public - including the investing public - about numerous RMBS transactions. The resolution also requires JPMorgan to provide much needed relief to underwater homeowners and potential homebuyers, including those in distressed areas of the country. The settlement does not absolve JPMorgan or its employees from facing any possible criminal charges.

The Justice Department, along with federal and state partners, today announced a $7 billion settlement with Citigroup Inc. to resolve federal and state civil claims related to Citigroup’s conduct in the packaging, securitization, marketing, sale and issuance of residential mortgage-backed securities (RMBS) prior to Jan. 1, 2009

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and time frames, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself.




Study Drug Attributes Affecting Site Selection Process

IP Environment.  Aside from needing sufficient storage space, many drugs have special storage requirements. Does the site have the equipment and resources needed to maintain and adequately monitor and record environmental conditions such as temperature or humidity? Do they have agreements with their vendors that guarantee a specific response time for repairing or replacing faulty equipment? If they lose electricity, do they have back up power, or at least provisions to move the IP off-site? (This is a common auditor question in hurricane-prone areas.)


Preparation of Study Drug.  Does your investigational product need to be reconstituted in a liquid? Do doses need to be compounded in different concentrations? Does the protocol require that an IV solution be prepared, filtered, and sterilized? These activities take time, specially trained personnel, and sometimes specialized equipment such as ventilation hoods. If your protocol demands an involved IP prep, your feasibility survey must include questions that allow you to assess these site capabilities and your pre-study visit should definitely include some time in the pharmacy. 

Drug Administration. Handing over a bottle of capsules to a study participant is one thing; inserting a butterfly catheter into an antecubital vein is something else again. If drug administration is very invasive, you’ll want to verify that the site has taken this into account when providing you enrollment projections. During subject visits, staff members may have to calculate doses, give intramuscular injections, perform infusions, or conduct sterilization procedures. You’ll want to verify that site staff has this expertise if required. Some clinical trials require a blinded dispenser who cannot be involved in any other study procedure or activities. If so, does the site have the resources for this?

Site Selection: it’s not just the PI, it’s the IP too
The study success and patient safety are jeopardized when a site can’t meet its enrollment target or doesn’t have the resources to execute the protocol. IP requirements can affect a site’s ability to do both. It’s critical that your site selection process – both your feasibility questionnaire and your pre-study visit – evaluate how well the site can meet the storage, preparation, and administration requirements of the study drug.

__________________________________________________________________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Photo Credit: By Harmid (Own work) [Public domain], via Wikimedia Commons

by Marshall Allen

The links to the viral video “Plandemic” started showing up in my Facebook feed Wednesday. “Very interesting,” one of my friends wrote about it. I saw several subsequent posts about it, and then my brother texted me, “Got a sec?”

My brother is a pastor in Colorado and had someone he respects urge him to watch “Plandemic,” a 26-minute video that promises to reveal the “hidden agenda” behind the COVID-19 pandemic. I called him and he shared his concern: People seem to be taking the conspiracy theories presented in “Plandemic” seriously. He wondered if I could write something up that he could pass along to them, to help people distinguish between sound reporting and conspiracy thinking or propaganda.

So I watched “Plandemic.” I did not find it credible, as I will explain below. YouTube, Facebook and Vimeo have since removed it from their platforms for violating their guidelines. Now it’s available on its own site.

Sensational videos, memes, rants and more about COVID-19 are likely to keep coming. With society polarized and deep distrust of the media, the government and other institutions, such content is a way for bad actors to sow discord, mostly via social media. We saw it with Russia in the 2016 election and we should expect it to continue.

But what surprised me is how easily “Plandemic” sank its hooks into some of my friends. My brother also felt alarmed that his own church members and leaders in other churches might be tempted to buy into it.

The purpose of this column is not to skewer “Plandemic.” My goal is to offer some criteria for sifting through all the content we see every day, so we can tell the difference between fair reporting and something so biased it should not be taken seriously.

Here’s a checklist, some of which I shared with my friends on Facebook, to help interrogate any content — and that includes what we publish at ProPublica.

Is the Presentation One-Sided?

There’s never just one side to a story. I mentioned this point in 2018 when I wrote about my faith and the biblical basis for investigative reporting. One of my favorite Proverbs says, “The first to state his case seems right until another comes and cross-examines him.” So a fair presentation should at least acknowledge opposing points of view.

I didn’t see this in “Plandemic,” so I called the filmmaker, Mikki Willis, who is also the film’s narrator, to ask him whether I had somehow missed the other side of the argument. I had not. “The other side of the argument plays 24/7 on every screen in every airport and on every phone and in every home,” Willis said. “The people are only seeing one side of the story all the time. This is the other side of the story. This is not a piece that’s intended to be perfectly balanced.”

I asked Willis if it was fair to call his film “propaganda,” which the Oxford dictionary defines as “information, especially of a biased or misleading nature, used to promote or publicize a particular political cause or point of view.”

He said he doesn’t feel there’s anything misleading in his film, but otherwise the definition fits. And based on that definition he feels 100% of news reporting is propaganda. “What isn’t propaganda these days?” he asked. “In that sense, what we’re doing is fighting fire with fire.”

Is There an Independent Pursuit of the Truth?

The star of “Plandemic,” medical researcher Judy Mikovits, is controversial. The magazine Science reports that it published and then retracted one of her papers in 2011. A search warrant provided to ProPublica by one of her former attorneys shows she was fired from her position at Whittemore Peterson Institute, a research center in Nevada, in September 2011. Then she allegedly stole notebooks and a laptop computer from the Institute, the search warrant said, leading to an arrest warrant for alleged possession of stolen property and unlawful taking of computer data. She was arrested on Nov. 18, 2011, but denied wrongdoing. The charges were dropped.

But “Plandemic” ignores or brushes past these facts and portrays her as an embattled whistleblower. “So you made a discovery that conflicted with the agreed-upon narrative?” Willis says to Mikovits, introducing her as a victim. “And for that, they did everything in their powers to destroy your life.”

A typical viewer is not going to know the details about Mikovits’ background. But as the primary source of controversial information being presented as fact, it’s worth an online search. The fact-checking site PolitiFact details her arrest and criminal charges. Clearly, there’s more to her story than what’s presented in “Plandemic.” That should give us pause when we assess its credibility.

Is There a Careful Adherence to the Facts?

In “Plandemic,” Willis asks Mikovits about her arrest: “What did they charge you with?”

“Nothing,” she replies. “I was held in jail, with no charges.”

Being charged with a crime is one of those concrete facts that we can check out. Science magazine reported Mikovits’ arrest and felony charge. I also found a civil lawsuit she filed against the Whittemore Peterson Institute in 2014 in the U.S. District Court for the Southern District of California. “Mikovits was arrested on criminal charges…” her complaint says in the case, which was eventually dismissed.

I asked Willis about the apparent discrepancy, where she said in his film that she wasn’t charged, when court documents show that she was charged. After my inquiry, he said he spoke to Mikovits and now feels it is clear that she meant that the charges were dropped.

I tracked down Mikovits and she said what she meant in the film is that there were no charges of any type of wrongdoing that would have led to her being charged with being a fugitive from justice. She admitted that all the controversy has been hard for her to sort out. “I’ve been confused for a decade,” she told me. She said she would try to be more clear in the future when she talks about the criminal charge: “I’ll try to learn to say it differently,” she said.

This underscores the importance of careful verification, and it distinguishes the craft of journalism from other forms of information sharing. People often speak imprecisely when they’re telling their stories. It’s our duty to nail down precisely what they do and do not mean, and verify it independently. If we don’t, we risk undermining their credibility and ours. That’s in part why we at ProPublica and many other journalists often link directly to our underlying source documents, so you can verify the information yourself.

Are Those Accused Allowed to Respond?

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is one of the nation’s leaders in the response to the coronavirus. In “Plandemic,” Mikovits accuses Fauci of a cover-up and of paying off people who perpetrate fraud, among other things. PolitiFact found no evidence to support the allegations against Fauci.

Every time I write a story that accuses someone of wrongdoing I call them and urge them to explain the situation from their perspective. This is standard in mainstream journalism. Sometimes I’ve gone to extreme lengths to get comments from someone who will be portrayed unfavorably in my story — traveling to another state and showing up at their office and their home and leaving a note if they are not there to meet me. “Plandemic” doesn’t indicate whether the filmmakers reached out to Fauci for his version of the story. So I asked Willis about it. “We did not,” he told me.

Are All Sources Named and Cited, and if Not, Is the Reason Explained?

All sources should be identified, with their credentials, so viewers can verify their expertise or possible biases. If they can’t be for some reason, then that should be explained. “Plandemic” features unnamed people in medical scrubs, presented as doctors, saying they’re being wrongly pressured to add COVID-19 on people’s death certificates or are not being allowed to use the drug hydroxychloroquine to treat patients. But the speakers are not named, so we can’t really tell who they are, or even if they are doctors at all. That makes it impossible to tell if they are credible.

I asked Willis why he didn’t name those people. He told me he was in a hurry to release the 26-minute version of “Plandemic,” but the doctors will be named in the final version. “We should have done that,” he said.

Does the Work Claim Some Secret Knowledge?

“Plandemic” calls itself a documentary that reveals “the hidden agenda behind COVID-19.” We are in the midst of a global pandemic where few people in the world can figure out what is happening or the right way to respond, let alone agendas. We have almost every journalist in the country writing about this. And if the truth about a conspiracy is out there, many people have an incentive to share it. But “Plandemic” would like us to think it’s presenting some exclusive bit of secret knowledge that is going to get at the real story. That’s not likely.

Plus, to be honest, there were so many conspiratorial details stacked on top of each other in the film I couldn’t keep them straight. When I spoke to Willis I told him I was having a hard time understanding his point. Then I took a stab at what I thought was the main thrust of his argument. “Are you saying that powerful people planned the pandemic and made it happen so they could get rich by making everyone get vaccines?” I asked.

It turns out Willis isn’t sure either. “We’re in the exploratory phase,” he told me. “I don’t know, to be clear, if it’s an intentional or naturally occurring situation. I have no idea.”

Then he went on to say that the pandemic is being politicized and used to take away our civil liberties and leverage other political policies. “Certain forces” have latched onto the situation, he said. “It’s too fishy.”

He had me at, “I have no idea.” That sums it up. This is a vast pandemic and massive catastrophe. Our country wasn’t prepared for it, and the response by our top leaders has been disjointed. We’re restricted to our homes. Many people have lost their jobs and some are afraid or sick or dying. That makes us vulnerable to exploitation by people who will present inaccurate or intellectually dishonest information that promises to tell us the truth.

Perhaps “Plandemic” is guilty of sloppy storytelling, or maybe people really do believe the things they’re saying in the video. Or perhaps they’re being intentionally dishonest, or it’s a biased connecting of the dots rooted in personal and professional grievances. I don’t know because I can’t get inside their heads to judge their motives.

Ultimately, we’re all going to need to be more savvy consumers when it comes to information, no matter how slickly it’s presented. This may be but a signal of what’s to come in the run-up to the 2020 presidential election, when memes and ads of unknown origin come across our social media feeds. There are standards for judging the credibility of the media we take in every day, so let’s apply them.

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The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public.

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Mar 26, 2020

Joseph Nye writes that while trade wars have set back economic globalization,  the environmental globalization represented by pandemics and climate change is unstoppable. Borders are becoming more porous to everything from drugs to infectious diseases to cyber terrorism, and the United States must use its soft power of attraction to develop networks and institutions that address these new threats.

Apr 27, 2020

The authors conducted a study which highlights how the U.S. public as a whole and various demographic groups view President Donald Trump's positions on nuclear weapons.

Apr 27, 2020

The authors conducted a study which highlights how the U.S. public as a whole and various demographic groups view President Donald Trump's positions on nuclear weapons.

Apr 29, 2020

Joel Clement appeared on CNN's Erin Burnett OutFront on April 23, 2020.  In this blog post for the Union of Concerned Scientists, he elaborates on what he wishes he had said during that interview.

May 7, 2020

Official figures exclude thousands who have died during the pandemic. To draw the right lessons, the United States needs an accurate tally of the victims.

Apr 27, 2020

The authors conducted a study which highlights how the U.S. public as a whole and various demographic groups view President Donald Trump's positions on nuclear weapons.

Apr 29, 2020

Joel Clement appeared on CNN's Erin Burnett OutFront on April 23, 2020.  In this blog post for the Union of Concerned Scientists, he elaborates on what he wishes he had said during that interview.

May 7, 2020

Official figures exclude thousands who have died during the pandemic. To draw the right lessons, the United States needs an accurate tally of the victims.

Feb 3, 2020

The study of existential risk — the risk of human extinction or the collapse of human civilization — has only recently emerged as an integrated field of research, and yet an overwhelming volume of relevant research has already been published. To provide an evidence base for policy and risk analysis, this research should be systematically reviewed. In a systematic review, one of many time-consuming tasks is to read the titles and abstracts of research publications, to see if they meet the inclusion criteria. The authors show how this task can be shared between multiple people (using crowdsourcing) and partially automated (using machine learning), as methods of handling an overwhelming volume of research.

Apr 27, 2020

The authors conducted a study which highlights how the U.S. public as a whole and various demographic groups view President Donald Trump's positions on nuclear weapons.

Mar 26, 2020

Joseph Nye writes that while trade wars have set back economic globalization,  the environmental globalization represented by pandemics and climate change is unstoppable. Borders are becoming more porous to everything from drugs to infectious diseases to cyber terrorism, and the United States must use its soft power of attraction to develop networks and institutions that address these new threats.

Apr 29, 2020

Joel Clement appeared on CNN's Erin Burnett OutFront on April 23, 2020.  In this blog post for the Union of Concerned Scientists, he elaborates on what he wishes he had said during that interview.

Mar 26, 2020

Joseph Nye writes that while trade wars have set back economic globalization,  the environmental globalization represented by pandemics and climate change is unstoppable. Borders are becoming more porous to everything from drugs to infectious diseases to cyber terrorism, and the United States must use its soft power of attraction to develop networks and institutions that address these new threats.

Apr 27, 2020

The authors conducted a study which highlights how the U.S. public as a whole and various demographic groups view President Donald Trump's positions on nuclear weapons.

Mar 26, 2020

Joseph Nye writes that while trade wars have set back economic globalization,  the environmental globalization represented by pandemics and climate change is unstoppable. Borders are becoming more porous to everything from drugs to infectious diseases to cyber terrorism, and the United States must use its soft power of attraction to develop networks and institutions that address these new threats.