A Brooklyn, N.Y., grand jury returned an indictment today against two former executives of Asiana Airlines, Inc. for participating in a conspiracy to fix economy class airfares paid by passengers for travel from the United States to the Republic of Korea.

The settlement declares the entire Isabella Reservation to be Indian Country, resolving longstanding disputes over the boundaries and existence of the Isabella Reservation in south central Michigan.

Attorney General Eric Holder served as the keynote speaker at the 12th National Indian Nations Conference in Palm Springs, Calif., during a week of outreach events organized by the Department of Justice that brought together tribal leaders and youth, law enforcement officers, lawyers and judges, policy experts and health and social services providers, and representatives from federal, state, local and tribal governments.

Horizon Lines LLC has agreed to plead guilty and to pay a $45 million criminal fine for its role in a conspiracy to fix prices in the coastal water freight transportation industry.

The Department of Justice marked the start of Sunshine Week today with the launch of FOIA.gov, the “flagship initiative” of the department’s Open Government Plan and one of the most significant contributions yet toward making this the most transparent administration in history.

"Sunshine Week is an important week for those of us who believe that government works best when the country knows what its government is doing. It is an opportunity to thank the many people inside and outside of government who have gotten us here, think about where we have to go next, and recommit ourselves to the goal of ensuring that government is open and transparent."

"Tonight, as we join together to commemorate this year’s National Crime Victims’ Rights Week, it is clear that we are also bound by our common goals, by our shared concerns, and by our collective resolve to do more to protect those at risk and in need – and to support every person, every family, and every community now struggling to overcome the devastating effects of crime."

"The Defending Childhood initiative seeks to redefine how the Justice Department responds to children who experience violence, witness violence, or suffer ongoing negative ramifications from violence. We hope to harness resources from across the Department - and across other federal agencies and state, local, and tribal partners – to first, prevent exposure to violence when possible; second to mitigate the negative impact of violence when it does occur; and third, to develop knowledge and spread awareness that will ultimately improve our homes, cities, towns, and communities."

Sea Star Line LLC has agreed today to plead guilty and to pay a $14.2 million criminal fine for its role in a conspiracy to fix prices in the coastal water freight transportation industry. Additionally, a federal grand jury in San Juan, Puerto Rico, returned an indictment against Frank Peake, the former president of Sea Star Line, for his role in the same conspiracy.

"Today and throughout the week, we have an important opportunity to showcase and celebrate the progress that’s been made here at the Department – and all across the federal government – in realizing the promise of the Freedom of Information Act," said Attorney General Holder.

"Tonight’s ceremony commemorates another year that has been distinguished by extraordinary achievements – but that has also, sadly, been marked by great tragedy," said Attorney General Holder.

More than 200 American Indian and Alaska Native youth and adult leaders from 53 tribal communities across the country have convened at the 2012 National Intertribal Youth Summit.

Jacksonville, Fla.-based Crowley Liner Services Inc. pleaded guilty and was sentenced to pay a $17 million criminal fine for its role in a conspiracy to fix prices in the coastal water freight transportation industry.

The U.S. District Court for the Eastern District of Virginia has approved a comprehensive settlement agreement between the United States and the Commonwealth of Virginia, resolving the department’s findings that Virginia’s system for serving people with intellectual and developmental disabilities violated the Americans with Disabilities Act (ADA). The department had found that Virginia was violating the ADA requirement, as interpreted by the Supreme Court’s decision in Olmstead v. L.C., to provide people with intellectual and developmental disabilities the opportunity to live and receive services in the community.

The U.S. District Court for the Southern District of New York entered a consent decree between the United States and a company that operates fan club websites for popular recording artists such as Justin Bieber and Selena Gomez, the Justice Department announced today. The government’s complaint, filed in connection with the decree, charges the company with violating both the Federal Trade Commission (FTC) Act and the Children’s Online Privacy Protection Rule. The company has agreed to pay a $1 million penalty to settle these charges.

"Like Special Agent Kiki Camarena, one person can and does make a difference. By joining me in wearing a red ribbon and gathering here today, and by celebrating Red Ribbon Week, you are helping make that difference," said Deputy Attorney General Cole.

The Justice Department announced today the filing of several criminal and civil business opportunity fraud cases, initiated as part of a joint sweep with the Federal Trade Commission and several states. Business opportunity fraud schemes take advantage of people looking for work by luring them in with false promises of big profits and leaving them worse off than they started.

U.S. Department of Justice Acting Associate Attorney General Tony West today addressed tribal leaders, law enforcement officers, lawyers and judges, policy experts and health and social services providers, and representatives from federal, state, local and tribal governments following a week of public safety events at the 13th National Indian Nations Conference in Agua Caliente, Calif.

The Department of Justice today announced that it will not challenge a proposal by Columbia Fuel Services Inc. and Lanmar Aviation Inc., the only providers of flight support services at the Groton-New London Airport, in Groton, Conn., to combine their fuel and hangar resources into a newly formed joint venture, Mystic Jet Center.

"Our Declaration of Independence declared in 1776 that “all men are created equal,” but it took 100 years and a civil war that took hundreds of thousands of lives to end slavery; another hundred years to create legal equality for African Americans; and we struggle to this day to make equality a reality. I see this every day in my work as the chief civil rights law enforcement official for the United States," said Assistant Attorney General Perez.

Following a two-week trial, a federal jury in Puerto Rico today convicted a former executive of a Florida-based coastal water freight transportation company for his participation in a conspiracy to fix rates and surcharges for water transportation of freight between the continental United States and Puerto Rico.

"While there is more work to be done and further improvements to be made, Sunshine Week is an opportunity to reflect upon our accomplishments thus far and to share the lessons we have learned as we continue to focus on our shared mission of strengthening FOIA administration across the government," said Director Pustay.

A federal grand jury in San Juan, Puerto Rico, returned an indictment against Thomas Farmer, a former executive of Jacksonville, Fla.-based Crowley Liner Services, for participating in a conspiracy to fix rates and surcharges for freight transported by water between the continental United States and Puerto Rico.

U.S. Attorney General Eric Holder and European Commission Vice President Viviane Reding met today in Washington, D.C. They had cordial discussions on a wide range of fields of collaboration between the Department of Justice and the European Commission.

Today the U.S. Marshals Service (USMS) concluded Operation Guardian, a three-year, national initiative specifically targeting the country’s most dangerous noncompliant sex offenders. Deputy Marshals and law enforcement partners arrested 345 individuals who had failed to register with state authorities as required by law.

The Department of Justice, six state attorneys general and the District of Columbia filed a civil antitrust lawsuit today challenging the proposed $11 billion merger between US Airways Group Inc. and American Airlines’ parent corporation, AMR Corp.

The former president of Sea Star Line LLC, a Jacksonville, Fla.-based water freight carrier, was sentenced to serve five years in prison and to pay a $25,000 criminal fine for his participation in a conspiracy to fix rates and surcharges for freight transported by water between the continental United States and Puerto Rico.

Four individuals were sentenced this week for their respective roles in trafficking the identities and corresponding identity documents of Puerto Rican U.S. citizens.

I also come to this discussion as my father's son. He was a man born and raised deep in the Jim Crow south. And when the time came for his eldest child and only son to take up driving lessons, dad was my teacher, imparting all the familiar lessons of keeping my eyes on the road and signaling before I turned.

U.S. Attorney General Eric Holder released the following statement Monday regarding the tragic shootings in Kansas yesterday.

A few days ago, many of you observed the beginning of Passover, marking the start of a long and difficult journey from tyranny and persecution toward freedom in the Promised Land. Today, this community begins its own journey of healing. And although the road ahead will not be easy, I promise you that I, and millions of others throughout our nation, will be here to walk alongside you – not only today, but always. We will never stop fighting for justice. And we will never forget the names, or the stories, of those we lost.

A North Carolina couple pleaded guilty for leading a Costa Rican sweepstakes fraud scheme that defrauded hundreds of elderly Americans

A dual United States-Costa Rican citizen pleaded guilty today for his role in a $1.88 million sweepstakes fraud scheme that defrauded hundreds of elderly Americans.

Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice.

Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets?


There’s a lot to consider.



What’s Your Standard of Care?
When deciding whether or not to conduct a particular study, a PI needs to verify that the protocol is aligned with practice norms. For example, an early phase trial might exclude a medication that is part of a practice’s routine therapy. Is the study placebo-controlled? Does it feature a specific comparator drug? Will it include a washout period? Any of these elements could present enrollment challenges or preclude a site from accepting a study at all. Responsible sites want to make thoughtful decisions about study suitability; they want to provide realistic enrollment estimates. Sponsors want this too, and can help sites do both these things by providing them a sufficient level of detail about protocol procedures as early as possible.


The Road to Deviations is Often Paved with Good Intentions
Therapeutic misconception – a well-documented phenomenon in clinical research – occurs when a study participant “fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment.”* Study participants are not alone in this. Researchers blur the distinction themselves when they conduct procedures that are consistent with clinical care but deviate from the protocol. This may be particularly true for PIs who recruit participants from their own practices. An endocrinologist might ordinarily reduce dosage for a particularly diminutive patient. A pulmonologist would often skip a scheduled chest x-ray she felt wasn’t needed to avoid exposing her patient to unnecessary radiation. An orthopedic surgeon may decide his patient needs more recovery time than usual before attempting her first walk. In a clinical care setting, these decisions are sound, made in an individual patient’s best interest. In a clinical trial, if they differ from the investigational plan and haven’t been approved by the Sponsor, they’re protocol deviations.**

It May be Par for the Course, But It's Still an AE
Specialists who have experience treating particular conditions are also familiar with the complications that ordinarily accompany them. A nephrologist, for instance, knows that a patient with end-stage renal disease frequently experiences bloat from a buildup of fluid between dialysis sessions. Though useful for a doctor treating patients, this knowledge can actually work against a doctor running a trial. How? A PI may fail to report a stomach ache as an AE because it’s so typical, so expected. “Bloat is common for renal patients. If I recorded every GI incident, I’d be recording AEs all day.” At its surface, this PI’s argument sounds reasonable, but what if the study drug itself is contributing to the participant’s discomfort? In order to assess the drug’s gastrointestinal effect, the PI must document the frequency and severity of all GI events.

Lab values that are either above or below normal range are also prime candidates for AE underreporting. “Of course the participant’s liver enzyme is high – we’re testing a cholesterol drug.”

The Importance of Study Oversight
Any GCP course worth its registration fee will discuss the distinction between standard of care and the study protocol. In practice, the distinction is not always as obvious as training sessions might suggest. This is where well-trained CRAs come in. As site monitors, CRAs are in a position to catch deviations that result from lapses into standard of care. Reading through progress notes, a monitor can ensure that any untoward medical event has been reported as an Adverse Event. They can verify that procedures conducted by the PI and site staff are compliant with the protocol. Then, by reviewing which types of data must be collected and emphasizing the importance of following certain protocol procedures, monitors can take the opportunity to re-educate study personnel and help them avoid these common pitfalls.

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* Lidz CW, Appelbaum PS (2002) The therapeutic misconception: problems and solutions. Med Care 40: V55-V63.

**Andrew Snyder of the HealthEast Care System wrote a thoughtful piece describing the compatibilities that do exist between clinical care and clinical research. His arguments provide a useful counterpoint to the issues we’re raising here. https://firstclinical.com/journal/2017/1707_Research_vs_Care.pdf

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

While dietary supplement sales have surged in recent months, the extent of the economic damage caused by the novel coronavirus and COVID-19 could lead to some very tough quarters as families and businesses start to run out of money.

City and county trails reopen this weekend. Almost every day, the rules change in the beaches and parks of Southern California. Here's the latest.

Celebrate Mother's Day with a livestream of the musical bio-drama "Hershey Felder as Irving Berlin"

Experts caution that even promising early results don’t guarantee that vaccines will be widely available anytime soon.

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