Nonprofit Solicitation under the Telemarketing Sales Rule

In 2003, the Federal Trade Commission ( FTC ) revised its Telemarketing Sales Rule ( TSR ) to establish a national Do-Not-Call Registry for commercial telemarketing. Congress directed the Federal Communications Commission ( FCC ) to coordinate its telemarketing regulations under the Telephone Consumer Protection Act ( TCPA ) of 1991 to achieve maximum consistency between the two agencies\u27 telemarketing restrictions. Nonprofit solicitation is exempt from the national Do-Not-Call Registry, but is covered by other provisions of the FTC rule. The TSR created a new in-house no-call list requirement and imposed additional restrictions not previously known for nonprofit solicitors. The separate nonprofit provisions of the TSR raise unique issues regarding the scope of FTC authority and First Amendment rights of nonprofit organizations. These regulations are being disputed in separate litigation from the challenge to the national Do-Not-Call Registry. This Article looks at the current state of regulatory activity targeting charitable telephone solicitation. First, Rita Marie Cain examines the FTC\u27s authority to adopt the provisions of the TSR that apply to nonprofit organizations. She argues that under free speech jurisprudence, charitable solicitation cannot be regulated like other commercial messages. Finally, Cain analyzes the new FTC restrictions on nonprofit solicitation to determine if they can withstand Constitutional scrutiny

Nonprofit Solicitation under the Telemarketing Sales Rule

In 2003, the Federal Trade Commission ( FTC ) revised its Telemarketing Sales Rule ( TSR ) to establish a national Do-Not-Call Registry for commercial telemarketing. Congress directed the Federal Communications Commission ( FCC ) to coordinate its telemarketing regulations under the Telephone Consumer Protection Act ( TCPA ) of 1991 to achieve maximum consistency between the two agencies\u27 telemarketing restrictions. Nonprofit solicitation is exempt from the national Do-Not-Call Registry, but is covered by other provisions of the FTC rule. The TSR created a new in-house no-call list requirement and imposed additional restrictions not previously known for nonprofit solicitors. The separate nonprofit provisions of the TSR raise unique issues regarding the scope of FTC authority and First Amendment rights of nonprofit organizations. These regulations are being disputed in separate litigation from the challenge to the national Do-Not-Call Registry. This Article looks at the current state of regulatory activity targeting charitable telephone solicitation. First, Rita Marie Cain examines the FTC\u27s authority to adopt the provisions of the TSR that apply to nonprofit organizations. She argues that under free speech jurisprudence, charitable solicitation cannot be regulated like other commercial messages. Finally, Cain analyzes the new FTC restrictions on nonprofit solicitation to determine if they can withstand Constitutional scrutiny

Putting a Gag on Farm Whistleblowers: The Right to Lie and the Right to Reamin Silent Confront State Agricultural Protectionism

Whistleblowers play an important role in filling gaps in government food safety systems. Unfortunately, several dominant food-producing states have pursued legislative initiatives that punish farm whistleblowers and silence investigative tactics. First, this research describes various state legislative initiatives that curb criticism of agriculture. The work analyzes the federal food safety system and how these protections limiting agricultural criticism contravene that food safety net. Further, the research analyzes the free speech concerns in the newest protectionist laws. The analysis recommends strategies and future research to improve agricluture safety and protect free speech in an evolving food safety landscape

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Supreme Court Upholds Compelled Subsidy Ads as Government Speech

Johanns v Livestock Marketing Association addressed whether regulated parties can be compelled by law to contribute to generic industry messages. In 1985, US Congress established a federal policy to promote beef products under the Beef Promotion and Research Act. Pursuant to the Act, the United States Department of Agriculture (USDA) requires cattle producers and importers to pay a fee on each head of cattle sold. The Livestock marketing Association represents hundreds of livestock auction marketers. It challenged the fees on the basis of the First Amendment free speech rights of its members. The Court's conclusion that the beef ads are government speech was based on the Beef Act statutory scheme that established: 1. the general terms of the promotions, 2. the Secretary of Agriculture's control over the Board, and 3. the Secretary's "absolute veto power" over advertising proposals. Livestock Marketing reveals that the government can tap into significant private resources to fund these promotions without regard to the free speech rights of dissenters

Intraoperative transfusion practices in Europe

Transfusion of allogeneic blood influences outcome after surgery. Despite widespread availability of transfusion guidelines, transfusion practices might vary among physicians, departments, hospitals and countries. Our aim was to determine the amount of packed red blood cells (pRBC) and blood products transfused intraoperatively, and to describe factors determining transfusion throughout Europe. We did a prospective observational cohort study enrolling 5803 patients in 126 European centres that received at least one pRBC unit intraoperatively, during a continuous three month period in 2013. The overall intraoperative transfusion rate was 1.8%; 59% of transfusions were at least partially initiated as a result of a physiological transfusion trigger- mostly because of hypotension (55.4%) and/or tachycardia (30.7%). Haemoglobin (Hb)- based transfusion trigger alone initiated only 8.5% of transfusions. The Hb concentration [mean (sd)] just before transfusion was 8.1 (1.7) g dl and increased to 9.8 (1.8) g dl after transfusion. The mean number of intraoperatively transfused pRBC units was 2.5 (2.7) units (median 2). Although European Society of Anaesthesiology transfusion guidelines are moderately implemented in Europe with respect to Hb threshold for transfusion (7-9 g dl), there is still an urgent need for further educational efforts that focus on the number of pRBC units to be transfused at this threshold