Race-Specific Drug 'BiDil': Nitromed's Marketing Challenge

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Case Details:

Case Code : MKTG154
Case Length : 29 Pages
Period : 2000-2006
Organization : NitroMed Inc.
Pub Date : 2006
Teaching Note : Available
Countries : USA
Industry : Pharmaceutical

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This case study was compiled from published sources, and is intended to be used as a basis for class discussion. It is not intended to illustrate either effective or ineffective handling of a management situation. Nor is it a primary information source.

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"The problem with BiDil is not only that it biologizes race but also that it uses race as biology to create the impression that the best way to address health disparities is through commercial drug development. By exploiting race in the service of product promotion, it distorts public understanding of health disparities and of efforts to address them."1

- Pamela Sankar2 and Jonathan Kahn3, in October 2005.

"In a sense, BiDil is a trial balloon for personalized medicine4."5

- B.J. Jones, vice president of marketing, NitroMed Inc., in April 2006.

"One way is to say, 'Gee, I am very disappointed we only have about 3 percent of eligible patients taking BiDil.' The other way is, very optimistically, to say: 'I have 97 percent of patients to penetrate.'"6

- Jerry Karabelas, CEO of NitroMed Inc., in August 2006.

The First 'Black-Only' Drug

In September 2006, NitroMed Inc. (NitroMed), a small pharmaceutical company in the US, launched a direct-to-consumer (DTC) advertising campaign for its drug named BiDil. BiDil was the first race-specific drug to be approved by the US Food and Drug Administration7 (FDA). BiDil is a fixed-dose combination8 of two known heart drugs isosorbide dinitrate9 (20 mg) and hydralazine hydrochloride10 (37.5 mg), for the treatment of heart failure11 in African Americans.12

Initially, the researchers did not intend to target the drug at any particular race. In 1997, the FDA rejected the application for the use of the drug in the general population on the basis of insufficient and inconclusive evidence in support of the drug.13

Retrospective analysis of data of an earlier clinical trial found that the drug worked better on the black population. On June 17, 2005, BiDil was approved by the FDA on the basis of the results of a clinical trial performed exclusively on black patients. (Refer to Exhibit I for a note on BiDil and African Americans, Exhibit II for the FDA press release announcing the approval of BiDil, Exhibit III for logo of BiDil, and Exhibit IV for BiDil's pack-shot).

Race-Specific Drug 'BiDil': Nitromed's Marketing Challenge - Next Page>>

1] Pamela Sankar and Jonathan Kahn, "BiDil: Race Medicine or Race Marketing," www.shc.stanford.edu, October 11, 2005.

2] Pamela Sankar is an assistant professor in the Department of Medical Ethics, University of Pennsylvania, in Philadelphia.

3] Jonathan Kahn is an assistant professor at the Hamline University School of Law in St. Paul, Minnesota.

4] Personalized medicine is the use of detailed information about a patient on the level of genes (the unit of heredity in living organisms) to tailor therapy or preventative measure that is particularly suited to that patient. Such an approach ensures accuracy, efficacy, safety, and speed in treatment.

5] Mark Jewell, "Drug Maker Breaking New Ground with Grassroots Marketing of BiDil," www.targetmarketnews.com, April 11, 2006.

6] Steven Syre, "NitroMed's Challenge," www.boston.com, August 10, 2006.

7] The FDA or the Food and Drug Administration of the US is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics, and blood products in the US. It approves drugs for certain indications and provides guidelines for the use of the drugs.

8] A fixed-dose combination is a formulation that contains more than one drug. It is convenient as instead of taking two or more drugs separately, a patient can take a single drug.

9] Isosorbide dinitrate belongs to the nitrates class of drugs that are used to treat chest pain due to impaired flow of oxygen and blood to the heart.

10] Hydrazine hydrochlorice is a drug used to treat high blood pressure.

11] Heart failure occurs when the heart cannot pump enough blood fast enough to meet the needs of the body. The condition may require hospitalization and medication to normalize blood flow in and out of the heart.

12] An African American (also referred to as black) is a member of an ethnic group in the US whose ancestors were predominantly indigenous to sub-saharan Africa.

13] A clinical trial is a research study that evaluates new drugs, medical devices, biologics, or other interventions for patients in strictly scientifically controlled settings, and are required for regulatory authority approval of new therapies. Normally, drugs become widely used as treatments for patients only when a well-designed clinical trial finds that the drug is safe and effective for patients of the same type and age.


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