Publications

Research investigations:

  1. Illingworth KD, Shaha SH, Tzeng TH, Sinha MS, Saleh KJ. The Impact of Tort Reform and Quality Improvements on Medical Liability Claims: A Tale of 2 States. American Journal of Medical Quality. 2015; 30(3):263-270.
  2. Kesselheim AS, Sinha MS, Joffe S. Physicians and Insider Trading. JAMA Internal Medicine. 2015 Dec 1; 175(12):1955-1959.
  3. Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorganic & Medicinal Chemistry. 2016 Dec 15; 24(24): 6446-6451.
  4. Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Internal Medicine. 2017 Nov 1;177(11):1658-1664.
  5. Sinha MS, Freifeld CC, Brownstein JS, Donneyong M, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Uptake of FDA Drug Safety Communication Messages about Zolpidem in Social Media. JMIR Public Health Surveill 2018; 4(1):e1.
  6. Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling Changes and Costs for Clinical Trials Performed under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012. JAMA Internal Medicine. 2018 Nov 1;178(11):1458-146.
  7. Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GJ, Zwanziger L, Ramanadham A, Enger C, Avorn J, Campbell EG. Patients’ Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey. J Law Med Ethics. 2019 Sep;47(3):430-441.
  8. Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ. Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem. Drug Saf. 2019 Nov;42(11):1287-1295.
  9. Hwang TJ, Sinha MS, Dave CV, Kesselheim AS. Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications. Mayo Clin Proc. 2019 Dec;94(12):2437-2443.
  10. Dave CV, Sinha MS, Beall RF, Kesselheim AS. https://www.healthaffairs.org/doi/10.1377/hlthaff.2019.00673 Health Aff (Millwood). 2020 Jun;39(6):1011-1017.
  11. Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS. FDA and EMA Biosimilar Approvals. J Gen Intern Med. 2020 Jun;35(6):1908-1910.
  12. Mostaghimi A, Antonini M-J, Plana D, Anderson PD, Beller B, Boyer EW, Fannin A, Freake J, Oakley R, Sinha MS, Smith L, Van C, Yang H, Sorger PK, LeBoeuf NR, Yu SH. Regulatory and safety considerations in deploying a locally-fabricated, reusable, face shield in a hospital responding to the COVID-19 pandemic. Med. 2020.
  13. Cramer AK, Plana D, Yang H, Tian E, Carmack M, Sinha MS, Krikorian D, Turner D, Li J, Gupta R, Manning H, Bourgeois FT, Yu SH, Sorger PK, LeBoeuf NR. Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE. Scientific Reports. 2021 Jan 21;11(1):2051.
  14. Beletsky L, Seymour S, Kang S, Siegel Z, Sinha MS, Marino R, Dave A, Freifeld C. Fentanyl panic goes viral: The spread of misinformation about overdose risk from casual contact with fentanyl in mainstream and social media. Int J Drug Policy. 2020 Sep 16;86:102951.
  15. Sinha MS, Sadik KW. Addressing the surgical shortage: revisiting residency training requirements for international medical graduates. Clin Surg J. 2021;2(2):1–8.
  16. Barenie RE, Sinha MS, Kesselheim AS. Factors affecting buprenorphine utilization and spending in Medicaid, 2002-2018. Value in Health. 2021 Feb;24(2):182-187.
  17. Antonini M-J, Plana D, Srinivasan S, Atta L, Achanta A, Yang H, Cramer A, Freake J, Sinha MS, Yu SH, LeBoeuf NR, Linville-Engler B, Sorger PK. A crisis-responsive framework for medical device development during the COVID-19 pandemic. Frontiers in Digital Health (Health Technology Innovation). 2021 Mar;3:617106.
  18. Plana D, Tian E, Cramer AK, Yang H, Carmack MM, Sinha MS, Bourgeois FT, Yu SH, Masse P, Boyer J, Kim M, Mo J, LeBoeuf NR, Li J, Sorger PK. Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic. BMC Infectious Diseases. 2021 Jul 29;21:712.
  19. Kothakanda A, Atta L, Plana D, Ward F, Davis C, Cramer A, Moran R, Freake J, Tian E, Mazor O, Gorelik P, Van C, Hansen C, Yang H, Sinha MS, Li J, Yu S, LeBoeuf NR, Sorger PK. De novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response. medRxiv. 2021.

Other peer-reviewed medical publications:

  1. Sinha MS. Commentary: Rousseau at the Roundtable – The Social Contract and the Physician’s Responsibility to Society. Virtual Mentor. 2011 Oct 1;13(10):703-706.
  2. Ryan M, Sinha MS. 2011, updated 2021. Informed Procedural Consent. UpToDate.com.
  3. Ryan M, Mekel M, Sinha MS. 2016, updated 2020. Disclosure of Errors in Surgical Procedures. UpToDate.com.
  4. Parmet WE, Sinha MS. A Panic Foretold: Ebola in the United States. Critical Public Health. 2017;27(1):148-155.
  5. Sinha MS, Kesselheim AS. The Effects of the Sunshine Act: What Can and Should We Expect? American Journal of Bioethics. 2017 Jun;17(6):22-24.
  6. Sinha MS, Kesselheim AS, Darrow JJ. Editorial: Pharmaceutical Advertising in Medical Journals: Revisiting an Old Relationship. Chest. 2018 Jan;153(1):9-11.
  7. Sinha MS, Kesselheim AS. Editorial: The Next Forum for Unraveling FDA Off-Label Marketing Rules: State and Federal Legislatures. PLoS Med. 2018 May 8;15(5):e1002564.
  8. Sinha MS, Curfman GD, Carrier MA. Viewpoint: Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry. JAMA. 2018 Jun 12;319(22):2271-2272.
  9. Silver JK, Rowe M, Sinha MS, Molinares DM, Spector ND, Mukherjee D. Ethical Legal Feature: Micro-inequities in Medicine. PM R. 2018 Oct;10(10):1106-1114.
  10. Silver JK, Sinha MS. Commentary: Sexual Harassment in Medicine: Toward Legal Clarity and Institutional Accountability. EClinicalMedicine 2019 Feb 7;7:3-4.
  11. Jain S, Madani K, Flint L, Swaroop M, Liu H, Varghese T, Sinha M, Silver J. What Does It Mean to Be a Male Ally? Implementing Meaningful Change in Gender Representation in Medicine. J Am Coll Surg. 2020 Mar;230(3):355‐356.
  12. Parmet WE, Sinha MS. Covid-19 - The Law and Limits of Quarantine. N Engl J Med. 2020 Apr 9;382(15):e28.
  13. Sinha MS, Bourgeois FT, Sorger PK. Personal Protective Equipment for COVID-19: Distributed Fabrication and Additive Manufacturing. Am J Public Health. 2020 Aug;110(8):1162-1164.
  14. Sinha MS, Powers, III JH, Kesselheim AS. The Wrong Cure: Financial Incentives for Unimpressive New Antibiotics. J Infect Dis. 2020 Aug 22:jiaa536.
  15. Slade DH, Sinha MS. Return to Work During COVID-19: Temperature Screening is No Panacea. Infect Control Hosp Epidemiol. 2020 Sep 23;1-2.

 

Law journal publications:

  1. Sinha MS. Barking Up the Wrong Tree: The FDA's Misguided Attempt to Waive Informed Consent in Public Health Emergencies. Journal of Legal Medicine. 2007; 28(3):397-417.
  2. Sinha MS, Parmet WE. The Perils of Panic Ebola, HIV, and the Intersection of Global Health and Law. American Journal of Law & Medicine. 2016;42(2-3):223-255.
  3. Sarpatwari A, Sinha MS, Kesselheim AS. The Opioid Epidemic: Fixing a Broken Pharmaceutical Market. Harvard Law & Policy Review. 2017;11(2):463-484.
  4. Sinha MS, Jain N, Hwang TJ, Kesselheim AS. Expansion of the Priority Review Voucher Program under the 21st Century Cures Act: Implications for Innovation and Public Health. American Journal of Law & Medicine. 2018 May;44(2-3):329-341.
  5. Darrow JJ, Sinha MS, Kesselheim AS. When Markets Fail: Patents and Infectious Disease Products. Food & Drug Law Journal. 2018;73(3):361-382.
  6. Sinha MS, Kesselheim AS. Health Policy Portal: The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry. Journal of Law, Medicine & Ethics. 2018 Sep;46(3):806-808.
  7. Kesselheim AS, Sinha MS, Avorn J, Sarpatwari A. Pharmaceutical Policy in the United States in 2019: An Overview of the Landscape and Avenues for Improvement. Stanford Law & Policy Review. 2019; 30(2): 421-480.
  8. Tessema FA, Kesselheim AS, Sinha MS. Generic But Expensive: Why Prices Can Remain High for Off-Patent Drugs. Hastings Law Journal. 2020;71(4):101-132.
  9. Gunnarsdottir HD, Sinha MS, Gerke S, Minssen T. Applying the Proportionality Principle to COVID-19 Antibody Testing. Journal of Law and the Biosciences 2020 Aug 4;7(1):lsaa058.
  10. Sinha MS, Messinger JC, Beletsky L. Neither Ethical Nor Effective: The False Promise of Involuntary Commitment to Address the Overdose Crisis. Journal of Law, Medicine & Ethics. 2020 Dec;48(4):741-743.
  11. Bresler J, Sinha MS. The Other Three Waves: Re-assessing the Impact of Industry-Prescriber Relations on the Opioid Crisis. Journal of Legal Medicine. Jan-Jun 2021;41(1-2):47-81.

 

Reviews, Chapters, Monographs, and Editorials:
  1. Gribble GW, et al. Novel Indole Chemistry in the Synthesis of Heterocycles. Current Organic Chemistry. 2005;9(15):1493-1519.
  2. Silverman RD, Sinha MS. Chapter 28—Mental Health Issues. Illinois Practice Series, Vols. 21 & 22: The Law of Medical Practice in Illinois. Kane RJ, Silverman RD, Singer LE, Eds. Supp. 2011.
  3. Sinha MS. COVID-19: State and Local Responses to PPE Shortages In Burris S, de Guia S, Gable L, Levin DE, Parmet WE, Terry NP, Eds. (2020). Assessing Legal Responses to COVID-19, Volume I. Boston: Public Health Law Watch.
  4. Sinha MS. Strategies to Address the Chronic Shortage of N95 Masks and Other Filtering Facepiece Respirators During the COVID-19 Pandemic. In Burris S, de Guia S, Gable L, Levin DE, Parmet WE, Terry NP, Eds. (2021). COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future. Boston: Public Health Law Watch.
  5. Heisler CA, Blaker M, Stephens EH, Sinha MS, Walsh K, Miller P, Temkin SM. Identifying and Eradicating Gender Discrimination and Sexual Harassment of Women Physicians in the United States. Stone L, Ed. (forthcoming 2022). Global Perspectives on Sexual Harassment in Medicine.
  6. Sinha MS, Bostyn SJR, Minssen T. Addressing Regulatory Exclusivity Issues During the COVID-19 Pandemic. Cohen IG, Gluck A, Kraschel K, Shachar C, Eds. (forthcoming 2022). COVID-19 and the Law: Disruption, Impact, and Legacy. Cambridge University Press.

 

Op-eds and Blogs:

  1. Sinha MS, Graham DR. H1N1 Questions & Answers. September 23, 2009. Springfield State Journal-Register, BeHealthySpringfield.com & Sangamon Medical News.
  2. Graham DR, Slade DH, Sinha MS. Preparing for the 2011-12 flu season. October 18, 2011. Springfield State Journal-Register.
  3. Sarpatwari A, Sinha MS. The Current 21st Century Cures Legislation Is Still A Bad Deal For Patients. Health Affairs Blog. November 30, 2016.
  4. Singer LE, Hutchinson E, et al. Letter: Professors Call Health Bills a ‘Giant Step Backward.’ The New York Times. June 23, 2017.
  5. Sinha MS, Kesselheim AS. The Future of American Science and Medicine. The Spoke (blog of the Albright Institute Faculty Scholar Initiative, Wellesley College). July 25, 2017.
  6. Silver JK, Sinha MS. Overwhelming Support for Gender Equity at the AMA. Doximity op-(m)ed. June 14, 2018.
  7. Title S, Sinha MS. Opinion: Vaping bans like Massachusetts’ will not stop illness outbreak. The Philadelphia Inquirer. October 7, 2019.
  8. Parmet W, Sinha MS. Opinion: Why we should be wary of an aggressive government response to coronavirus. The Washington Post. February 3, 2020.
  9. Gunnarsdottir HD, Sinha MS. Antibody assay for COVID-19, some legal and ethical issues. Letter to Icelandic Minister of Health, Surgeon General, and Chief Epidemiologist. April 17, 2020.
  10. O’Neill Institute for National and Global Health Law, Georgetown Law School. Letter to Congress on WHO Withdrawal from Public Health, Law and International Relations Leaders. June 30, 2020.
  11. Plana D, Arfé A, Sinha MS. Re-Envisioning Clinical Trials During the COVID-19 Pandemic. Health Affairs Blog. July 8, 2020.
  12. Lurie P, Gonsalves G, et al. Letter in Support of Dr. Anthony Fauci and His Role in the U.S. COVID-19 Response. July 17, 2020.
  13. Kesselheim AS, Avorn J, et al. Open Letter to FDA Commissioner Stephen Hahn: #ProtectTheFDA September 25, 2020.
  14. Sinha MS, Latham S. Patient advocacy organizations and FDA drug approval: Lessons from Aduhelm. STAT News First Opinion. July 23, 2021.
 

Federal Comments:

  1. Sinha MS, Kesselheim AS. Comments on Public Workshop: ‘Generic Drug User Fee Amendment of 2012.’ June 2, 2017.
  2. Sarpatwari A, Sinha MS, Kesselheim AS. Comments on Public Meeting: ‘Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.’ November 10, 2017.
  3. Public Health Law Watch. A Response to "Unintended Consequences: Medicaid and the Opioid Crisis." February 14, 2018.
  4. Public Health Law Watch. Comments on Regulatory Provisions: ‘Inadmissibility on Public Charge Grounds.’ December 7, 2018.
  5. Sinha MS. Comments on Public Meeting: Responsible Innovation in Dietary Supplements. July 17, 2019.
  6. Sinha MS. Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing. November 18, 2019.
  7. Sinha MS. FDA Solicits Input on Potential Role for Abuse-Deterrent Formulations of Central Nervous System Stimulants; Establishment of a Public Docket; Request for Comments. November 18, 2019.
  8. Tobacco Products; Required Warnings for Cigarette Packages and Advertisements. November 27, 2019 (revised and contributed to 7 law student submissions as part of the Fall 2019 Drug Law & Policy course at NUSL)
  9. Plana D, Arfé A, Sinha MS. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic; Guidance for Industry, Investigators, and Institutional Review Boards. July 13, 2020.
  10. Treatment of E-Cigarettes in the Mail. March 22, 2021 (revised and contributed to 10 law student submissions as part of the Spring 2021 Problems in Public Health Law course at NUSL).
  11. Sinha MS. National Institute of Standards and Technology (NIST) Request for Comments; Rights to Federally Funded Inventions and Licensing of Government Owned Inventions. April 6, 2021.
  12. Sinha MS, Beall RF. Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments; Reopening of Comment Period. April 15, 2021.
  13. Phased Approach to the Resumption of Cruise Ship Passenger Operations 2021-09094. June 30, 2021 (revised and contributed to 20 law student submissions as part of the Summer 2021 Problems in Public Health Law course at NUSL).
 

Theses:

  1. Sinha MS. Synthesis of Novel Anti-tumor Alkaloids. [Honors undergraduate thesis]. On file, Department of Chemistry, Hanover, NH: Dartmouth College, 2003.
  2. Sinha MS. Improving Healthcare Transitions for Releases from Boston-Area Jails. [MPH practicum project]. On file, Department of Health Policy and Management, Boston, MA: Harvard T.H. Chan School of Public Health, 2015.