Drug Marketing Masquerading as Research

In her 2005 New York Times Business Bestseller "The Truth About the Drug Companies — How They Deceive Us and What to Do About It," Marcia Angell, M.D., the former editor in chief of the New England Journal of Medicine, coined the phrase "drug marketing masquerading as research" to describe several common practices by which pharmaceutical manufacturers use corrupt or biased research to promote drugs.

Common Practices

These practices include paying contract research organizations ("CROs") and private doctors to conduct flimsy Phase IV or "post-marketing" research studies, ghostwriting of journal articles supposedly authored by prominent academics, and paying academic experts to put their names on biased journal articles.

Off-Label Marketing

Several whistleblowers have taken issue with such practices in qui tam actions filed under the False Claims Act, often in the context of off-label marketing of drugs for uses not yet approved by the FDA. It is a criminal violation of the Food, Drug and Cosmetics Act for drug companies to promote the use of their drugs for indications not listed on the FDA-approved labeling. Several recent settlements of off-label marketing cases have resulted in criminal fines and civil settlements ranging in value from hundreds of millions to more than a billion dollars.

Payment of Kickbacks

It is also a criminal violation of the federal Anti-Kickback Statute for drug companies to offer or pay any remuneration to induce a doctor or medical researcher to recommend the ordering of any drug for which payment may be made by a federal healthcare program such as Medicare or Medicaid. When a drug company uses consulting fees and other forms of financial remuneration to lure academics into authoring flimsy research studies that promote their drugs, civil and criminal violations of the Anti-Kickback Statute may be implicated.

Beyond Off-Label Marketing

Although issues of these sorts are often raised in the context of off-label marketing of drugs for unapproved uses, off-label marketing is not an essential ingredient of the fraud that is actionable under the False Claims Act in a qui tam action filed by a whistleblower. The real heart of the whistleblower's claims under the False Claims Act is that drug marketing has been permitted to masquerade as legitimate scientific research due to kickbacks and other conflicts of interest that have impaired the judgment of medical researchers. Such fraudulent conduct increases claims against government healthcare programs for drugs that may be only marginally safe and effective, whether FDA-approved or not.

*****************
WM. Paul Lawrence, II serves as of counsel to Waters & Kraus, LLP. His practice focuses on appellate, class action, and qui tam (whistleblower) litigation under the False Claims Act.