Free Research Paper About Maintaining Ethics In Pharmaceutical World: A Concerted Effort Required

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All pharmaceutical products are directly related to human health, and its target consumer group includes patients and physicians, who rely on drug companies to address all health concerns. However, the point of conflict arises when the objective of those companies (to maximize profit) clash with consumer interest (to get safe and effective health solution). This was amply explained by Thompson, when he stated that conflicts of interest is “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (e.g. financial gain)” (573). It clearly highlights the significance of the ethical dimension that is expected to act as a primary barrier to the marketers whenever the commercial prospect of a product involves violation of standardized norms as recommended by the competent authority such as U.S. Food and Drug Administration (FDA), which is driven by its vision of proactively “increasing the availability and diversity of safe and effective products that relieve animal pain and suffering, sustain their health, improve animal productivity and do not compromise public health” (“Vision”).
The above vision of FDA clearly highlights the significance of two ethical issues in the U.S. pharmaceutical marketing world, such as truth and honesty of the product, and marketing products that are not safe. This study thus explores them with an aim to find the way/s that would be appropriate to influence the pharmaceutical companies to provide true and honest product description and to refrain from marketing potentially unsafe products.

Problem Statement

Even as the modern society is not as credulous as it was in pre-digital era, the instances of getting carried away by inflated claims of many pharmaceutical products are not uncommon, since more often than not people get overdriven by the desire of possessing quality mental and physical health and consequently, facts appear uninteresting to them than stories (Furgurson). To make the most of such situations, the marketers create a want, instead of meeting an existing need (that can be addressed in a falsifiable manner), where the factors such as price and evaluation of the product features do not play as deciding factors for customers (Godin 18). Thus it becomes explicitly clear that the pharmaceutical companies that launch such products ignore the facts such as their products should safely and effectively address respective health problems and their consumers include patients and physicians, who rely on them.

Truth and Honesty of the Product

In case of American pharmaceutical industry, the drug companies spend around $25 billion in promoting their prescription medications, of which around $5 billion is spent on direct-to-consumer (DTC) advertising. Amid this scene, the Office of Prescription Drug Promotion (OPDP) under FDA is charged by law to ensure that advertising as well as other promotional materials carry accurate descriptions of the products placed within DTC (“Keeping Drug Advertising Honest”). Thus one can easily assume that all advertisements in this segment do not carry exact claims.
The issue of influencing consumers through material or cash incentives also involves the above-mentioned ethical issues, especially when a product associated with such promotional activities is found as positioned with false claims and unsafe by one or the other health grounds. Cosgrove et al. (229) present a comprehensive list of various types of financial associations between physicians and pharmaceuticals that can be considered as unethical, and since such moves are generally initiated by the companies, they cannot be exempted from the charge of unethical act. Alongside, it also becomes clear that it is not possible for FDA along to track down all instances of dishonest portrayal of products.

Marketing a Product that is Not Safe

Osmosis Skincare's new UV Neutralizer Harmonized Water claims that it can block 97% of UVA, as its scalar waves have a cancellation effect on UV radiation. Its promotional web page suggests that it conducted trial with 24 patients ranging from 18 to 60 years with various ethnic backgrounds and 16 of them showed positive results Alongside, it states that the company accepts cannot be held responsible for any adverse consequences having direct or indirect association with the use of their product. (“UV Neutralizer-Tan Frequency”). Apart from that, it does not explain what scalar wave is, but research shows that it is a purported type of electromagnetic wave that is indefinable by the laws of physics (“Scalar Potentials”). This product has been marketed recently and could be an ideal example of marketing products that are not safe. Instances like this, therefore, lead to the exploration regarding how FDA can prevent marketing this type of product.
The drug companies submit their advertising and promotional materials to OPDP, and an estimate of 2013 showed that OPDP received 6,000-8,000 pieces of advertising and promotional materials. OPDP has 32 reviewers to check those pieces, who are healthcare professionals with diverse professional and academic backgrounds. They apply a risk-based approach to identify advertising materials that can create negative impact on public health. For example, if an ad suggests that a particular drug is more effective or carries less severe side effects than what are suggested by the technical data regarding that product, then they consider that advertisement as false or misleading (“Keeping Drug Advertising Honest”). FDA removes a drug from the market when it is found that the risks associated with a drug are outweighing the benefit it offers. This discovery may take several routes, such as a drug may contain certain composition that cannot be rectified, or a drug may cause serious side effects that were unknown at the time of approval. However, extreme care and caution applied by FDA before removing a drug, since that could be dangerous for the people who already developed dependency on that drug. FDA applies another strategy to check the usage of newly approved drugs that may have hidden dangerous side effects, such as putting up articulated warnings on the labels of new products regarding the unknown state of its future effects (“How does FDA decide”).
It becomes clear, however, by the time FDA concludes that the UV Neutralizer Harmonized Water is unsafe and should be banned, the company would do a brisk selling over a long period of time and thereby harming a large number of unsuspecting consumers. This substantiates the fact that FDA initiative is too little to handle the enormity of the situation.

Impact of Social Media

According to Thomas Abrams, the Director of OPTP, social media has made it very easy for the marketers to make false claims about a product. For example, the drug companies are heavily using social platforms Facebook or YouTube for product promotion where many advertisements are carrying false information regarding products. A recent report shows that pharmaceutical companies have increased their online advertising expenses from $1.03 billion in 2010 to $1.86 billion by 2015 (Iskowitz).
Although OPTP has a system of monitoring these spheres of advertising, it relies more on the surveillance by people to check dishonest advertisements and therefore they posted information on how to notify OPTP on their  Bad Ad web page (“Keeping Drug Advertising Honest”). This clearly establishes the fact it requires a concerted effort to maintain ethics in the U.S. pharmaceutical industry.

Conclusions and Recommendations

The expansion of advertising space in this digital era has increased the scope of dishonest marketers to market products that are not safe, and it virtually impossible to monitor the incessant flow of advertising through various digital platforms. In addition, the technology of convergence has enabled the marketers to reach consumers through mobile apps, where there is no way to monitor who is sending what to whom. Therefore, it is virtually impossible for FDA alone to maintain ethics in pharmaceutical companies, as the review clearly underpins FDA’s initiatives as inadequate to monitor and address incessant instances of ethical violation in pharmaceutical industry. This automatically leads to the inference that a concerted effort comprising of FDA, NGOs, and people is required to maintain ethics in pharmaceutical world.

Works Cited

Cosgrove, Lisa, Bursztajn, Harold J., Krimsky, Sheldon, Anaya, Maria, and Walker, Justin. “Conflicts of interest and disclosure in the American Psychiatric Association’s clinical practice guidelines.” Psychotherapy and Psychosomatics 78 (2009): 228–232. Print.
Furgurson, John. Truth, Lies, and Advertising Honesty. 18 October, 2012. Web. 14 April 2015. <http://www.brandinsightblog.com/2012/10/18/truth-lies-and-advertising-honesty/>
Godin, Seth. All Marketers Are Liars: The Underground Classic That Explains How Marketing Really Works--and Why Authenticity Is the Best Marketing of All. Portfolio, 2012. Print.
Haque, Omar Sultan, De Freitas, Julian, Bursztajn, Harold J., Cosgrove, Lisa, Gopal, Abilash A., Paul, Robindra, Shuv-Ami, Itay, and Wolfman, Samuel. The Ethics of Pharmaceutical Industry Influence in Medicine. Israel: UNESCO, 2013. Print.
“How does FDA decide when a drug is not safe enough to stay on the market?” FDA. 2014. Web. 14 April 2015. <ww.fda.gov/aboutfda/transparency/basics/ucm194984.htm>
Iskowitz, Marc. Pharma poised to up online ad spend. Medical Marketing and Media. 2012. Web. 14 April 2015. <http://www. mmm-online.com/pharma-poised-to-up-online-ad- spend-emarketer/ article/201584/>
“Keeping Drug Advertising Honest and Balanced. FDA. 2013. Web. 14 April 2015. <http://www.fda.gov/forconsumers/consumerupdates/ucm355270.htm>
“Scalar Potentials and Scalar Waves.” Research Media & Cybernetics. 2015. Web. 15 April 2015. <http://www.rmcybernetics.com/science/physics/electromagnetism2_scalar_waves.htm>
Thompson, Dennis F. “Understanding financial conflicts of interest.” New England Journal of Medicine 329 (1993): 573–576.
“UV Neutralizer-Tan Frequency.” Osmosis. 2015. Web. 15 April 2015. <http://www.osmosisskincare.com/HarmonizedWater-UV.aspx>
“Vision.” FDA. 2013. Web. 14 April 2015. <http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cvm/cvmvisionandmission/uc m072554.htm>