Publications

June 2023 (Revised July 2024)
Case

Biogen and the Aduhelm Melee

By: Amitabh Chandra and Lauren Gunasti

Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.

This... View Details

Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry

2004
Book

Pharmacopolitics: Drug Regulation in the United States and Germany

By: Arthur A. Daemmrich

Keywords: Health; Governing Rules, Regulations, and Reforms; Government and Politics; United States; Germany

01 Mar 2013
News

Opening the Door

For her innovative research and outspoken advocacy of US health-care reform, Professor Regina Herzlinger is known in some media circles as "the godmother of consumer-driven health care." At HBS, she holds the distinction of being the... View Details

Keywords: Deborah Blagg; Colleges, Universities, and Professional Schools; Educational Services; Social Assistance; Health, Social Assistance; Management

2023
Working Paper

The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina

By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle

We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed... View Details

Keywords: COVID-19; Health Care and Treatment; Health Pandemics; Adoption; Behavior; Governing Rules, Regulations, and Reforms; Learning

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December 2024
Article

Is There Too Little Antitrust Enforcement in the U.S. Hospital Sector?

By: Zarek Brot-Goldberg, Zack Cooper, Stuart Craig and Lev Klarnet

From 2002 to 2020, there were over 1,000 mergers of U.S. hospitals. During this period, the Federal Trade Commission (FTC) took enforcement actions against 13 transactions. However, using the FTC’s standard screening tools, we find that 20% of these mergers could have... View Details

Keywords: Monopoly; Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Competition; Health Industry

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2024
Working Paper

Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational Advances

By: Amar Bhidé and Srikant M. Datar

In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works, 2) the foundational advances and discoveries, 3) the... View Details

Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms

SSRN

03 Dec 2015
Op-Ed

How "New Nuclear" Power Could Save the Planet—If Regulators Would Allow It

Leaders from some 150 nations have convened in Paris this week for the COP21 conference with a singular goal: to fight the global threat of climate change. Each of them have brought to Paris their own national plan for reducing greenhouse gas emissions that drive... View Details

Keywords: by Joseph Lassiter; Energy

2008
Chapter

Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation

By: Arthur A. Daemmrich

A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details

Keywords: Geographic Location; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Demand and Consumers; Pharmaceutical Industry; European Union; Germany; United States

11 May 2010
First Look

First Look: May 11

understood, even as the United States, Germany, and the United Kingdom instituted reforms in early 2010. Presenting opportunities for cross-national policy learning, this case describes the political economy of healthcare reform. In late... View Details

Keywords: Martha Lagace

01 Jun 2005
News

One-on-One with Grover Norquist

twenty years at the forefront of tax reform advocacy, what achievements would you like to be known for? My single most important achievement was creating the Taxpayer Protection Pledge, a promise never to raise taxes. Since 1986, we have... View Details

Keywords: Government

2010
Chapter

From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance

By: Arthur A. Daemmrich

Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Business and Government Relations; Risk and Uncertainty; Safety; Pharmaceutical Industry; United States

01 Sep 2010
News

Noted & Quoted

also be a statutory cap on leverage, a maximum speed limit, if you will, that regulators can’t loosen.” — HBS professor David Moss commenting on the need for financial reform legislation to place limits on the amount banks can borrow for... View Details

Keywords: Securities, Commodities, and Other Financial Investments; Finance; Hospitals; Health, Social Assistance

January 2009 (Revised February 2009)
Case

Sydney IVF: Stem Cell Research

By: Robert L. Simons, Kathryn Rosenberg and Natalie Kindred

This case examines the strategy implementation and risk management decisions at Sydney IVF, a research-based in vitro fertilization and stem cell company based in Australia. Drs. Robert Jansen and Jock Anderson, who co-founded Sydney IVF in 1986, developed novel... View Details

Keywords: Ethics; Governing Rules, Regulations, and Reforms; Innovation and Management; Growth and Development Strategy; Risk Management; Genetics; Commercialization; Health Industry; Australia

06 Oct 2015
First Look

October 6, 2015

at the Narayana Health City Cardiac Hospital (NH) in India. The case discusses the factors driving the adoption of task shifting at NH and identifies the implications of task shifting for surgeon training, surgical capacity, and procedure... View Details

Keywords: Sean Silverthorne

28 Jul 2009
First Look

First Look: July 28

report, new CEO Hank McKinnell discusses Pfizer's performance goals and its acquisition of Pharmacia, which gave it control of the anti-arthritis drug Celebrex. In the 2005 report, McKinnell discusses his decision to keep Celebrex on the market despite View Details

Keywords: Martha Lagace

Article

Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials

By: Caroline Marra, William J. Gordon and Ariel Dora Stern

Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of... View Details

Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology

2023
Article

Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control

By: Susanna Gallani

Can managers use monetary incentives to elicit cooperation from workers they cannot reward for their efforts? I study “conduit incentives,” an innovative incentive design, whereby managers influence bonus-ineligible workers’ effort by offering bonus-eligible employees... View Details

Keywords: Organizational Behavior Modification; Peer Monitoring; Persistence Of Performance Improvements; Crowding Out; Implicit Incentives; Compensation; Healthcare; Social Pressure; Image Motivation; Incentives; Motivation; Performance; Behavior; Motivation and Incentives; Compensation and Benefits; Governing Rules, Regulations, and Reforms; Organizational Culture; Health Industry; California

September 2009 (Revised August 2012)
Case

Novasys Medical

By: Richard G. Hamermesh and Lauren Barley

Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of FDA approval, the American Medical Association has been unwilling to approve the... View Details

Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Health Disorders; Product Development; Business and Government Relations; Medical Devices and Supplies Industry; United States