Michael S. Sinha

Bio: Michael S. Sinha is an academic researcher from Harvard University. The author has contributed to research in topics: Personal protective equipment & Face shield. The author has an hindex of 12, co-authored 48 publications receiving 584 citations. Previous affiliations of Michael S. Sinha include Boston Medical Center & Northeastern University.

Covid-19 - The Law and Limits of Quarantine.

Abstract: Covid-19 — The Law and Limits of Quarantine Community transmission of the new coronavirus is occurring in several parts of the United States, and travel bans and mandatory quarantines alone cannot ...

Determinants of Market Exclusivity for Prescription Drugs in the United States

Abstract: The high prices of brand-name prescription drugs are a growing source of controversy in the United States. Manufacturers of brand-name drugs can command high prices because they are protected from generic competition by two types of government-granted monopoly rights. The first are patents on the drugs that generally define the basic period of brand-name-only sales. The second is awarded at the time of US Food and Drug Administration (FDA) approval and usually defines the minimum time until a generic can be sold. The initial patents last for 20 years and may be extended to account for time spent in clinical trials and regulatory review; other laws prevent approval of other manufacturers’ versions of new drugs for about 6 to 7 years, and for new biologics for 12 years. Overall, most new drugs receive about 12 to 16 years of market exclusivity from both kinds of monopoly protection combined. We reviewed the peer-reviewed medical and health policy literature to identify studies that described the different types of patent protection and regulatory exclusivities that shield brand-name prescription drugs from competition and thus help to sustain high drug prices. We also identified potential policy reforms intended to modify exclusivity periods to address public health needs by balancing drug affordability and industry revenue. The goal of policy in this area should be to ensure that drug market exclusivity periods provide for fair return on investment but do not indefinitely block availability of lower-cost generic drugs.

Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic.

Abstract: Summary Background Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of products such as protective face shields. No clear path exists, however, for introducing a locally fabricated product into a clinical setting. Methods We describe a research protocol under Institutional Review Board supervision that allowed clinicians to participate in an iterative design process followed by real-world testing in an emergency department. All designs, materials used, testing protocols, and survey results are reported in full to facilitate similar efforts in other clinical settings. Findings Clinical testing allowed the incident command team at a major academic medical center to introduce the locally fabricated face shield into general use in a rapid but well-controlled manner. Unlike standard hospital face shields, the locally fabricated design was intended to be reusable. We discuss the design and testing process and provide an overview of regulatory considerations associated with fabrication and testing of personal protective equipment, such as face shields. Conclusions Our work serves as a case study for robust, local responses to pandemic-related disruption of medical supply chains with implications for health care professionals, hospital administrators, regulatory agencies, and concerned citizens in the COVID-19 and future health care emergencies. Funding : This work was supported by the Harvard MIT Center for Regulatory Sciences, NIH/NCI grants U54-CA225088 and T32-GM007753, and the Harvard Ludwig Center. M.-J.A. is a Friends of McGovern Graduate Fellow.

Catalytic Functionalization of Indoles in a New Dimension

Abstract: 140 years ago Adolf von Baeyer proposed the structure of a heteroaromatic compound which revolutionized organic and medical chemistry: indole. After more than a century, indole itself and the complexity of naturally occurring indole derivatives continue to inspire and influence developments in synthetic chemistry. In particular, the ubiquitous presence of indole rings in pharmaceuticals, agrochemicals, and functional materials are testament to the ever increasing interest in the design of mild and efficient synthetic routes to functionalized indole derivatives. This Review emphasizes the achievements in the selective catalytic functionalization of indoles (C-C bond-forming processes) over the last four years.

COVID-19 diagnosis and management: a comprehensive review.

Abstract: Severe acute respiratory syndrome coronavirus (SARS-CoV)-2, a novel coronavirus from the same family as SARS-CoV and Middle East respiratory syndrome coronavirus, has spread worldwide leading the World Health Organization to declare a pandemic. The disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), presents flu-like symptoms which can become serious in high-risk individuals. Here, we provide an overview of the known clinical features and treatment options for COVID-19. We carried out a systematic literature search using the main online databases (PubMed, Google Scholar, MEDLINE, UpToDate, Embase and Web of Science) with the following keywords: 'COVID-19', '2019-nCoV', 'coronavirus' and 'SARS-CoV-2'. We included publications from 1 January 2019 to 3 April 2020 which focused on clinical features and treatments. We found that infection is transmitted from human to human and through contact with contaminated environmental surfaces. Hand hygiene is fundamental to prevent contamination. Wearing personal protective equipment is recommended in specific environments. The main symptoms of COVID-19 are fever, cough, fatigue, slight dyspnoea, sore throat, headache, conjunctivitis and gastrointestinal issues. Real-time PCR is used as a diagnostic tool using nasal swab, tracheal aspirate or bronchoalveolar lavage samples. Computed tomography findings are important for both diagnosis and follow-up. To date, there is no evidence of any effective treatment for COVID-19. The main therapies being used to treat the disease are antiviral drugs, chloroquine/hydroxychloroquine and respiratory therapy. In conclusion, although many therapies have been proposed, quarantine is the only intervention that appears to be effective in decreasing the contagion rate. Specifically designed randomized clinical trials are needed to determine the most appropriate evidence-based treatment modality.

Alarming trends in US domestic violence during the COVID-19 pandemic.

Abstract: Portland, Oregon public schools closed March 16, 2020 and on March The COVID-19 pandemic caused by the acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused significant destruction worldwide. In the United States (US) as of April 18, 2020 there were 690,714 reported cases and 35,443 deaths [1]. In order to curb the spread of SARS-CoV-2 quarantines, social isolation, travel restrictions and stay-at-home orders have been adopted [2,3]. While many states in the US implement stay-at-home orders differently, in most cases individuals are expected to stay indoors except for essential activities (e.g., obtaining food, medication, medical treatment) or for work in essential businesses (e.g., health care, essential infrastructure operations). Although these measures can be effective to control the spread of disease, they have a profound impact on society leading to social, financial and psychological repercussions. Isolation may expose or worsen vulnerabilities due to a lack of established social support systems. The temporary shutdown of non-essential businesses has led to unemployed and economic strain [4]. Quarantine conditions are associated with alcohol abuse, depression, and post-traumatic stress symptoms [5]. Stay-at-home ordersmay cause a catastrophicmilieu for individuals whose lives are plagued by domestic violence (DV). DV usually occurs in a domestic space when one individual holds power over another. DV is a broad term and typically includes intimate partner violence (IPV) (e.g., usually occurs between current or former intimate partners and includes stalking, psychological, sexual and physical violence) elder abuse (e.g., involves negligent or intentional acts which cause harm) and child abuse (e.g., includes neglect, physical harm, sexual violence, and emotional harm) [6]. However, for the purpose of report we will primarily refer to DV as it pertains to IPV. Forms of DV such as IPV are unfortunately quite common. According to the CDC, approximately 1 in 4 women and 1 in 10 men report experiencing some form of IPV each year [7]. In the wake of the COVID-19 pandemic trends regarding DV are already starting to emerge on a global scale. Reports from local police near the epicenter of the COVID-19 outbreak in China's Hubei province, indicate that DV tripled during February 2020 compared to February 2019 [8]. Also, according to the United Nations entity UN Women, DV reports in France have increased 30% since they initiated a March 17 lockdown. DV calls in Argentina have increased 25% since their March 20 lockdown [9]. The organization also reports a 30% increase in helpline calls in Cyprus and 33% increase in Singapore [9]. However, in the US, the effect of the COVID-19 pandemic on DV is just beginning to be realized via anecdotal reports since there is limited data available