\u3ci\u3eUnited States v. Caronia\u3c/i\u3e: Off-Label Drug Promotion and First Amendment Balancing

Off-label drug promotion is commonplace in the United States, but it is not without its dangers. While the Food, Drug, and Cosmetic Act does not explicitly ban off-label promotion, the Food & Drug Administration (FDA)— in order to protect consumers from unsafe and ineffective drugs—has taken steps to regulate it. The FDA does so through its intended-use regulation, which lists the types of evidence the FDA can consider in determining whether a drug is misbranded. It is a crime to sell a misbranded drug into interstate commerce or to conspire to do so. On September 25, 2015, the FDA proposed an amendment to the regulation, which has drawn opposition from various industry groups due to its potential to restrict the type of speech that is often used in off-label promotion. The First Amendment challenge to the proposed amendment rests on United States v. Caronia, in which the FDA was prevented from using truthful, nonmisleading speech to convict a pharmaceutical representative of a conspiracy to sell a misbranded drug. This Note examines whether the amendment to the regulation is permissible under Caronia. It first contends that the regulation does not facially violate the First Amendment. It further argues that the rule is constitutional and does not pose the same First Amendment issue as was seen in Caronia as long as the FDA implements it with care. This Note concludes by exploring various ways that the FDA can constitutionally regulate off-label drug promotion under the proposed rule

Electrochemical Studies of Substituted Anthraquinones

Electrochemical potentials of a series of anthraquinone derivatives were studied in both aqueous solution and acetonitrile. The long term goal of this work was to find derivatives which could be reduced easily for studies of photoinduced electron transfer in DNA. Our immediate goal was to find the substitution group that gave the least negative redox potential value. Of all derivatives studied, the anthraquinone imides as a class had the least negative redox potentials, in the range of -0.600 to -0.550 V vs. SCE. One of the anthraquinones studied, one derivative (deoxyadenosine conjugated with an ethynyl linker to an anthraquinone with two ester substituents) was also in this range. A study of a series of anthraquinones conjugated with ethynyl and ethanyl linkers showed that the ethynyl linker was more effective than the ethanyl linker in lowering the redox potential of anthraquinone

Jefferson\u27s Patient Encounter Log System (PELS)

No abstract available

Anesthesiologist-led COVID-19 Airway Training Skills Session to teach novel team approach and workflow

What’s the Problem? Intubation is an aerosol-generating procedure that poses a significant infectious risk to the operator in the COVID-19 era, where the volume of intubations was expected to increase dramatically. Following national anesthesia societal and organizational recommendations regarding best practices to decrease risk of viral transmission, a new 3-person airway team approach was developed. Additions to the preexisting airway management workflow included an aerosol-containing intubation shield, a new breathing circuit configuration incorporating HEPA filtration, and the use of unfamiliar PPE, all of which required mastery of a complex sequence of events surrounding the patient encounter. This high-stakes workflow was a substantial departure from standard practice and a broad educational effort was required. A departmental simulation was developed to this end

Initiatives in Anesthesia Workspace Hygiene During COVID-19: The Gray Airway Basin and the Epic Hand Hygiene Event

What’s the Problem? The COVID-19 Pandemic has highlighted the need for anesthesia providers to decrease workspace contamination, particularly during and after airway management. Delineation of “clean” and “dirty” spaces in the anesthesia workplace has been historically challenging, but the heightened awareness of microbial contamination presents a new opportunity to effect behavioral change among staff

Metabolite concentrations, fluxes and free energies imply efficient enzyme usage.

In metabolism, available free energy is limited and must be divided across pathway steps to maintain a negative ΔG throughout. For each reaction, ΔG is log proportional both to a concentration ratio (reaction quotient to equilibrium constant) and to a flux ratio (backward to forward flux). Here we use isotope labeling to measure absolute metabolite concentrations and fluxes in Escherichia coli, yeast and a mammalian cell line. We then integrate this information to obtain a unified set of concentrations and ΔG for each organism. In glycolysis, we find that free energy is partitioned so as to mitigate unproductive backward fluxes associated with ΔG near zero. Across metabolism, we observe that absolute metabolite concentrations and ΔG are substantially conserved and that most substrate (but not inhibitor) concentrations exceed the associated enzyme binding site dissociation constant (Km or Ki). The observed conservation of metabolite concentrations is consistent with an evolutionary drive to utilize enzymes efficiently given thermodynamic and osmotic constraints

Health Care Financing Reforms in Italy: Projects of Jefferson\u27s Center for Research in Medical Education and Health Care

No abstract available

Creation of a Dedicated Anesthesia Airway Cart For Use in High-Volume COVID-19 Airway Management

The COVID-19-specific approach to intubation required a change in the team structure and workflow for emergent airway management. New need for bulky PPE and the introduction of an aerosol barrier shield for emergent intubations Higher volume of intubations and use of videolaryngoscopy requires additional equipment Concern for Code Cart contamination and wastage of airway equipment Desire for more efficient approach to selecting and customizing equipmen