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

Write 300 words on discussion and respond to two articles with 200 words each

1)Write 300 words for discussion with 3 peer reviewed references

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?

 

2) Respond to two articles with 200 words each

Article 1



If I am the manufacturer of the drugs, I will not voluntarily disclose the study information. I would have to use my expertise to make this decision. This would constitute a clear breach of my ethical obligation as a member of society to disclose information relevant to medical research that may harm society. I believe that the study is essential and will take it to the regulatory authorities if necessary. This information could provide potential competitors with a competitive advantage through anti-competitive pricing or by giving them the edge from a lack of competition (Costel et al., 2017). This is a significant concern for pharmaceutical companies. The problem for society, in general, is that companies might use the information they gain from marketing for their purposes.

I might not disclose it until legal protections have been exhausted. This is because of risks associated with the confidentiality of the study and the potential harm of disclosure. The confidentiality protection of research data is a federal mandate. Although there are many methods of conducting personal research and therefore must be kept confidential, there are specific requirements regarding confidentiality. However, the companies involved in the marketing and research must be aware that, in the case of safety or effectiveness claims on pharmaceutical products, they must be highly cautious when divulging trade secrets. Pharmaceutical companies are responsible for developing and quality the drugs in a country, and a thorough understanding of their product is essential for successful marketing (Chang et al., 2017). Thus, the information available in the public domain is being used by the government to secure its information infrastructure and protect its assets and reputation and those individuals or organizations who wish to create new innovative technologies.

References

Chang, J. C., Holland, C. L., Tarr, J. A., Rubio, D., Rodriguez, K. L., Kraemer, K. L., … & Arnold, R. M. (2017). Perinatal illicit drug and marijuana use: an observational study examines the prevalence, screening, and disclosure. American Journal of Health Promotion31(1), 35-42.

Costello, K. L., Martin III, J. D., & Edwards Brinegar, A. (2017). Online disclosure of illicit information: Information behaviors in two drug forums. Journal of the Association for Information Science and Technology68(10), 2439-2448.

Article 2

The researchers concluded that there is a three time increase in risk of ovarian cancer in women who take Pergonal. It is also found that there is a one to two time increase in risk of ovarian cancer with Serophene. Companies claim that their medication is safe to use because other studies have shown that the increased risk of cancer is only with the duration of the treatment of the medication. They will also provide their customers who take the medication with the knowledge on the risk of cancer should they decide to use the medication. This is considered a serious issue for the companies since knowing about the risk, patients may decide not to use the medication and seek other more promising medication or the patients are less likely to seek medical help for the disease which has a very slow rate of growth. As the companies know there is a high risk of ovarian cancer, they can be more conscious in the safety of the treatment of their customers. This is expected to reduce the possibility of the risk of developing ovarian cancer in the future (Diergaarde, 2019).

There are numerous medicines or drugs being developed in the pharmaceutical industry in the present time. For a safe and effective treatment of an illness, it is very important for the people to know the harmful side effects of the medication. To provide the information, various scientific methods and methods are employed. When the manufacturers know about the effect of the drug on the human body, they can make their customers know the side effects of the drug and can make the decisions on how to treat the illness. If I’m a manufacturer of one of the drugs I will disclose the study information of the company has a great responsibility in making its consumers more informed. The company can provide some valuable information to the people which they can easily interpret. This also enables the customers to make the decisions on how to prevent the onset of the disease (Ness, 2017).

References

Diergaarde, B., & Kurta, M. L. (2019). Use of fertility drugs and risk of ovarian cancer. Current Opinion in Obstetrics & Gynecology, 26(3), 125–129. https://doi.org/10.1097/gco.0000000000000060

Ness, R. B. (2017). Infertility, Fertility Drugs, and Ovarian Cancer: A Pooled Analysis of Case-Control Studies. American Journal of Epidemiology, 155(3), 217–224. https://doi.org/10.1093/aje/155.3.217

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