"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.

Joseph Vito Mastronardo Jr., 63, of Meadowbrook, Pa., pleaded guilty today to conspiring to participate in a racketeering enterprise.

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.

Today, the Justice Department asked a federal court to dismiss the injunction to address civil rights violations at Saint Elizabeths Hospital in Washington, D.C., because the District of Columbia and the Department of Behavioral Health have significantly improved the care and treatment of persons confined to Saint Elizabeths Hospital. Saint Elizabeths is the district’s facility for treating individuals with mental health conditions. The reforms, which were implemented following requirements under a court order, have ensured that persons at Saint Elizabeths Hospital are discharged to the community with adequate supports to live in integrated settings. Further, the reforms resulted in important improvements in integrated treatment planning, psychological and psychiatric services, nursing care and protection from assault.

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

Obese mice with unhealthy lifestyles gain significantly less weight and avoid type 2 diabetes when they receive bacteriophages from the faeces of a lean mouse, according to a new University of Copenhagen study.

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.

The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary…

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage.

The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee.

“Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.”

Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs.

Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind.

###

 

Biotech venture funding metrics continue at historic highs, highlighting that the robust financing environment in the public markets continues to fuel the private markets as well.  – Bruce Booth, partner Atlas Venture in Data Snapshot: Venture-Backed Biotech Financing Riding High, April 2015 Here in Madison, Wisconsin, you might not know that was true if you

The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for.

npj Microgravity, Published online: 24 February 2020; doi:10.1038/s41526-020-0096-x

Effect of simulated microgravity on the antidiabetic properties of wheatgrass (Triticum aestivum) in streptozotocin-induced diabetic rats

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?