Reference no: EM133053639

Testify Until it Hertz

Brice Hertz is the head of research for PharmaSee Industries, Inc. Over the past year, PharmaSee has developed a new type of gastrointestinal medication that appears to be tremendously effective. PharmaSee calls it "GastroT." Currently, PharmaSee is seeking FDA approval for the use of GastroT for patients that are suffering from serious conditions that cause intense nausea, such as cancer-therapy patients.

In the process of researching GastroT among a variety of potential users, PharmaSee has learned that the drug also has potential as a hangover cure or to dull the negative effects of alcohol abuse. In fact, among serious alcoholics, GastroT allowed them to drink even more than usual. The unfortunate result, though, was that among people with alcohol problems, the use of GastroT led to increased deaths. Even among occasional alcohol users, the availability of GastroT led to increased use of alcohol and even there, a mildly increased percentage of alcohol poisoning and alcohol-related deaths (including from accidents and falls).

PharmaSee has upcoming FDA hearings on GastroT and its effectiveness in its use for cancer patients. As the research is very positive with that group, the company expects to receive approval. In fact, the company is very excited because it projects that its new drug will help more than a million cancer patients in its first year, not to mention earning some nice revenue on those sales. Brice Hertz expects to receive a bonus for his work on the project, and the company is projecting strong earnings and great shareholder reception.

But Hertz also has research that shows that no matter how hard the company tries to contain and restrict use of GastroT to special users and patients, it will almost certainly end up in the hands of the general public for misuse. And that misuse will lead to increased injury and death, especially among alcohol users and abusers.

Brice Hertz is expecting that he will be called to testify at the upcoming FDA hearings. Should Hertz stick to his script and answer the questions that are within the scope of this hearing: Whether the drug will be effective for cancer patients and if it should be approved for that use? Or should Hertz try to find a way to bring the alternate uses and potential abuses to the attention of the FDA? If Hertz isn't allowed to testify to this at the hearing, should Hertz release the reports he has about GastroT's potential? Or is Hertz, by releasing this report, actually causing the problem by cluing people in to the alternate uses of the drug?

Looking at this from a practical perspective, what specifically is Brice Hertz's ethical dilemma? What options does Hertz have and what are the ethical issues involved in those options? What would you do if you were Hertz?