Mother Teresa expected much of others but even more of herself.

After conducting a careful investigation of the proposed transaction between Oracle and Sun, the Department’s Antitrust Division concluded that the merger is unlikely to be anticompetitive.

"After a thorough review of the evidence, the division has determined that the proposed transaction is not likely to substantially lessen competition in the United States."

Attorney General Eric Holder and Algerian Minister of Justice Tayeb Belaiz today signed a treaty between the United States and Algeria on mutual legal assistance in criminal matters, the first ever criminal law enforcement agreement between the two countries.

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.

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.

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.

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.

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.

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.

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.

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.

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.

_______________________________________________________________________
* 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.

Mar 17, 2020

On December 5, 1994, leaders of the United States, the United Kingdom, and the Russian Federation met in Budapest, Hungary, to pledge security assurances to Ukraine in connection with its accession to the Treaty on the Nonproliferation of Nuclear Weapons (NPT) as a non-nuclear-weapons state. The signature of the so-called Budapest Memorandum concluded arduous negotiations that resulted in Ukraine’s agreement to relinquish the world’s third-largest nuclear arsenal, which the country inherited from the collapsed Soviet Union, and transfer all nuclear warheads to Russia for dismantlement. The signatories of the memorandum pledged to respect Ukraine’s territorial integrity and inviolability of its borders, and to refrain from the use or threat of military force. Russia breached these commitments with its annexation of Crimea in 2014 and aggression in eastern Ukraine, bringing the meaning and value of security assurance pledged in the Memorandum under renewed scrutiny.

On the occasion of the 25th anniversary of the memorandum’s signature, the Project on Managing the Atom at the Belfer Center for Science & International Affairs at the Harvard Kennedy School, with the support of the Center for U.S.-Ukrainian Relations and the Harvard Ukrainian Research Institute, hosted a conference to revisit the history of the Budapest Memorandum, consider the repercussions of its violation for international security and the broader nonproliferation regime, and draw lessons for the future. The conference brought together academics, practitioners, and experts who have contributed to developing U.S. policy toward post-Soviet nuclear disarmament, participated in the negotiations of the Budapest Memorandum, and dealt with the repercussions of its breach in 2014. The conference highlighted five key lessons learned from the experience of Ukraine’s disarmament, highlighted at the conference.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Mar 3, 2020

Could China and the US be stumbling down the path Germany and the United Kingdom took at the beginning of the last century? The possibility will strike many readers as inconceivable. But we should remember that when we say something is “inconceivable,” this is a claim not about what is possible in the world, but rather about what our limited minds can imagine.

My answer to the question of whether we are sleepwalking toward war is “yes.” 

Khurshid talks about challenges of his job, and in light of controversy surrounding Law Ministry.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Mar 17, 2020

On December 5, 1994, leaders of the United States, the United Kingdom, and the Russian Federation met in Budapest, Hungary, to pledge security assurances to Ukraine in connection with its accession to the Treaty on the Nonproliferation of Nuclear Weapons (NPT) as a non-nuclear-weapons state. The signature of the so-called Budapest Memorandum concluded arduous negotiations that resulted in Ukraine’s agreement to relinquish the world’s third-largest nuclear arsenal, which the country inherited from the collapsed Soviet Union, and transfer all nuclear warheads to Russia for dismantlement. The signatories of the memorandum pledged to respect Ukraine’s territorial integrity and inviolability of its borders, and to refrain from the use or threat of military force. Russia breached these commitments with its annexation of Crimea in 2014 and aggression in eastern Ukraine, bringing the meaning and value of security assurance pledged in the Memorandum under renewed scrutiny.

On the occasion of the 25th anniversary of the memorandum’s signature, the Project on Managing the Atom at the Belfer Center for Science & International Affairs at the Harvard Kennedy School, with the support of the Center for U.S.-Ukrainian Relations and the Harvard Ukrainian Research Institute, hosted a conference to revisit the history of the Budapest Memorandum, consider the repercussions of its violation for international security and the broader nonproliferation regime, and draw lessons for the future. The conference brought together academics, practitioners, and experts who have contributed to developing U.S. policy toward post-Soviet nuclear disarmament, participated in the negotiations of the Budapest Memorandum, and dealt with the repercussions of its breach in 2014. The conference highlighted five key lessons learned from the experience of Ukraine’s disarmament, highlighted at the conference.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Mar 3, 2020

Could China and the US be stumbling down the path Germany and the United Kingdom took at the beginning of the last century? The possibility will strike many readers as inconceivable. But we should remember that when we say something is “inconceivable,” this is a claim not about what is possible in the world, but rather about what our limited minds can imagine.

My answer to the question of whether we are sleepwalking toward war is “yes.” 

Mar 4, 2020

Given that the Turkish-backed SNA has clearly stated their intention to launch another operation against the SDF, how will the US ensure that the ammunition provided to Turkey is not used against the SDF?

Aug 6, 2019

Former U.S. Energy Secretary Ernie Moniz and former U.S. Sen. Sam Nunn argue in a new Foreign Affairs article that the threat of nuclear war between Russia and the U.S. is higher now than at any point since the Cuban Missile Crisis.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.

Apr 13, 2020

Since President Trump moved into the White House, he has been eager for a dramatic initiative with Russian President Vladimir Putin, and he may finally have found one in Sunday’s announcement of a joint American-Russian-Saudi effort to stabilize world oil prices.