Question

Stanford University medical researchers conducted a study on the correlation between the use of fertility drugs and ovarian cancer. Their study, published in the American Journal of Epidemiology, concludes that the use of the fertility drugs, Pergonal and Serophene, may increase the risk of ovarian cancer by three times. The lead author of the studies, Professor Alice Whittemore, stated, "Our finding in regard to fertility drugs is by no means certain. It is based on very small numbers and is really very tenuous."

FDA Commissioner David Kessler would like the infertility drug manufacturers to disclose the study findings and offer a warning on the drug packages. He notes, "Even though the epidemiology study is still preliminary, women have a right to know what is known. We're not looking to make more of this than there is."

Answer this question:

If you were a manufacturer of one of the drugs, would you voluntarily disclose the study information?

Answer 1

No, if I were a manufacturer of one of the drugs I would not voluntarily disclose the study information.

This is because of the fact that the findings of the study have not been proved on the basis of a large sample and hence the possibility is that the findings that were based on the small numbers or the small sample size is untenable.

As a drug manufacturing entity it is my moral and ethical obligation to inform all my customers of any side effects or potential health hazards that may occur from the use of the drugs manufactured by me. I am responsible for the health of my customers and will provide all necessary warnings as well as disclosures that are required keeping in mind the best interests of my customers and drug users.

However, in this case, the study that has been conducted is a kind of a preliminary study. It will not be proper to disclose its findings, as a warning, as the findings are not properly proved, confirmed and clinically correlated. Once the findings are properly confirmed and clinically correlated I will accept my moral and ethical responsibility and will voluntarily disclose the required information and any required warning.