A Response to Professor Menell: A Remix Compulsory License Is Not Justified

At the recent Columbia Law School Kernochan Center Symposium Creation Is Not Its Own Reward: Making Copyright Work for Authors and Performers, a diverse group of creators, academics, lobbyists and practicing attorneys presented their views on how copyright law succeeds or fails in providing the creators of copyrighted works with appropriate rights and protections in the ever-changing digital copyright ecosystem. Speakers disagreed not only on whether or not the copyright system was working in favor of or against the interests of creators, but also on fundamental copyright principles. This is not surprising; while most academics and practitioners seem to accept, to one extent or another, that creators are not treated well in the digital age, there is no consensus on the 200-year-old constitutional threshold question: should copyright be viewed as a property interest or an economic theory? If a property interest, then copyright might actually work better for authors and performers in the future. But if an economic theory, the chance for authors and performers to thrive and prosper in the digital era decreases dramatically

Data driven estimation of foodborne disease incidence in Ethiopia

Objectives Surveillance of foodborne disease (FBD) remains a challenge worldwide. Available incidence estimates are based on secondary data and expert opinion and suffer from considerable uncertainty, particularly in low- and middle-income countries where the burden of unsafe foods is higher. Accurate estimates of incidence are crucial for efficient allocation of public health resources. We designed an epidemiological framework for the estimation of FBD incidence using primary data and Ethiopia as a pilot country. Materials and methods Laboratory, healthcare facility and community cross-sectional surveys were conducted simultaneously in three sites in Ethiopia. Faecal samples from diarrheal patients submitted to three clinical laboratories were tested for selected foodborne pathogens and rates of laboratory confirmed cases were estimated. Data from healthcare facilities on incidence of diarrhea among patients and referral practices; and the community on incidence of diarrhea and healthcare seeking practices were used to adjust incidence rates for under-diagnosis and under-testing. Results Between October 2021 and January 2022, 567 faecal samples were submitted; 0.8%, 13.1% and 3.7% were presumptive positive for non-typhoidal Salmonella, shiga toxin-producing Escherichia coli (STEC) and Campylobacter, respectively. Two percent (n=3,960) of individuals in the community had experienced diarrhea in the past 4 weeks, 60% of which sought healthcare, with men more likely to seek healthcare compared to women. Preliminary estimates suggest incidence of Campylobacter and STEC is significantly higher than non-typhoidal Salmonella. Pathogen-specific incidence varies greatly across regions. Conclusion Campylobacter and STEC are commonly present in diarrhea stools and their role in FBD may be larger in Ethiopia than previously believed. Results suggest that diarrhea stool screening in laboratories, currently restricted to few pathogens, is likely to provide a biased picture of the principal causes of FBD and should be expanded to include other important but currently overlooked foodborne pathogens

Regulatory role of the 3′ untranslated region of luteinizing hormone receptor: effect on mRNA stability

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/117193/1/feb2s001457930001365x.pd

Repeated ovarian stimulation with corifollitropin alfa in patients in a GnRH antagonist protocol: no concern for immunogenicity

BACKGROUND One injection of corifollitropin alfa replaces the first seven daily FSH injections in controlled ovarian stimulation (COS) cycles. Repeated treatment with therapeutic proteins may cause immune responses or hypersensitivity reactions. We assessed the immunogenicity and safety of corifollitropin alfa treatment in up to three COS cycles. METHODS In this multicentre, phase III uncontrolled trial, patients (>60 kg) started treatment with one injection of 150 µg corifollitropin alfa on cycle Day 2 or 3 of menses and 0.25 mg ganielix on stimulation Day 5 or 6. Primary outcome measures were antibody formation against corifollitropin alfa (using highly sensitive radioimmunoprecipitation assay), hypersensitivity reactions, local tolerance and adverse events (AEs). RESULTS First, second and third COS cycles were started by 682, 375 and 198 patients, respectively. No clinically relevant immunogenicity or drug-related hypersensitivity was observed. For 192 patients undergoing their third cycle a post-treatment blood sample was negative in the anti-corifollitropin antibody assay, resulting in an upper limit of the one-sided 95% confidence interval (CI) of 1.5%. Most frequent AEs were procedural pain (17.7%, 95% CI: 14.9–20.8%), headache (9.1%, 95% CI: 7.0–11.5%) and pelvic pain (7.6%, 95% CI: 5.7–9.9%). Cumulative ongoing pregnancy rate after three cycles, including frozen-thawed embryo transfer cycles and spontaneous pregnancies, was 61% (95% CI: 56–65%) after censoring for patients who discontinued. CONCLUSIONS Treatment with corifollitropin alfa can safely and effectively initiate and sustain ovarian stimulation during the first 7 days of COS in normal responder patients undergoing up to three treatment cycles, without concerns of immunogenicity.Robert J. Norman, Fernando Zegers-Hochschild, Bruno S. Salle, Jolanda Elbers, Esther Heijnen, Maya Marintcheva-Petrova, and Bernadette Mannaerts for the Trust Investigator

A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol

Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 mu g corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9% for the corifollitropin alfa group and 38.1% for rFSH were achieved, with an estimated non-significant difference of 0.9% [95% confidence interval (CI): -3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulus-oocyte-complexes compared with rFSH [estimated difference 1.2 (95% CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7%, respectively P = 0.15). Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800