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."

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

Please Answer the above Questions No Plagiarism NEED 400 WORDS

Answer 1

The given case leads to an ethical dilemma where it was given that whether the drug manufacturer should disclose the drug-related information to customers or not. A study by the Stanford University medical researchers has found that there exists a correlation between the use of the fertility drugs and ovarian cancer where these conclusions were drawn by taking a small size sample (Jennings, 2015). Now, being a drug manufacturer, the decision has to be whether the information will be disclosed to drug users or it is going be kept as a secret. It is expected that the drug manufacturers have to develop their own policies of whether they should disclose the drug-related information to customers or not but provided that they develop these regulations as per the standard of the HIPPA.

But, in most of the cases, companies despite violating the HIPPA rules and had has been viewing it as a marketing strategy. Thus, it is very important to adhere to HIPPA and at the same time taking the flexibility in designing the disclosure of the drug-related information (Geetter & Buettner, 2017). LaMattina investigated that the United States (US) drug manufacturers or the marketing authorization holders are expected to disclose any drug-related, serious, and any sudden effects with the use of the drugs within 15days. As per the U.S. FDA code of federal legislation; 21 CFR 314.80, if there is any follow-up information related to drugs, then it has to be disclosed within the next 15days of the initial information release (LaMattina, 2013). Hence, if I am the drug manufacturer, then I will maintain transparency and disclose drug-related information to customers. This factor is very important because adhering to the regulations formed by the respective governments creates a good reputation in the market.