Rio Salado College DIY Products and Biotechnological Social Movement Discussion Response
I’m working on a health & medical writing question and need support to help me learn.
Respond to the following Discussion Posts. These need to be at least 2 paragraphs and 400-500 words. Each paragraph must be a minimum of 7 sentences long.
Original Question:
Melanie
First and foremost, DYI unregulated products often provide inadequate information such as misleading labeling, or incorrect product ingredients, as well as false device capabilities. In looking at how unregulated products are without constraints, and there are no restrictions in place to control them, it is my opinion that these medications pose threats leading to severe adverse events. Unregulated products have misleading properties which can be detrimental to a person’s health and life. It’s like the products sold by biohackers online which promise to cure certain ailments and they do quite the opposite. One would ask, what are these medications created without medical safeguards and reviews? These types of medications are not approved by the FDA, and for the most part have not undergone clinical trials to determine its medical advantages, disadvantages or risks. For this type of instances, I would notify first the IRB, FDA and the Sponsor to allow an audit and review to be conducted to determine if the unregulated medications are safe for human use and treatments. Unregulated products are considered as “dangerous products”. (Unregulated Products. CPSC.gov). For example, many years ago, private companies that promote medical products such as pills for all health reasons were on the rise. I believe these companies were selling DYI products illegally and with false advertising of the product’s capabilities.
In my opinion; I do not agree with the process of biohacking. I believe people should not experiment on themselves with unregulated products because of how dangerous these unsafe materials are, and how they are not certified or credible to provide the cure or medical relief they may project, as well as for other purposes. I myself have disregarded many illicit advertisements of medical products and all types of unregulated items through online popups and unknown emails. I knew right away, that if I drink this solution, or put this in my hair, or eat this item I could become sick. In the past, as I have been involved with clinical research and will be in my future career, I do feel that a high level of regulations to ensure certain protections are in place to protect people from self-experimenting with unregulated medications and devices. It is noted that “unregulated products are unlawful. Unregulated products are often viewed as unlawful and with a lot of suspicion, mainly because they do not require regulatory approval.” (Unregulated Products).
Many unregulated products stem from items people use every day such as apparel, automotive, baby items, beauty and hair care, books, foods, drinks, personal and health care and pet products. This guidance over unregulated products can be monitored the same as with approved products. Manufacturers must be held accountable to disclose the truth of what these products are and does for the human body, device or other DYI product variety. I believe the manufacturer of DYI products must show transparency in its product labeling and indications which brings awareness to its risks and safety issues. Documentation can be recorded and required which keep an accurate accounting of its presence in human and public markets. The consequences of findings that self-experiments were taking place can be fines, and in worse case scenarios banning the DYI products from being marketed, sold and used in the U.S by companies and individuals. It is with this premise that I believe by placing certain regulations and sanctions on the biohacking products, and unregulated product variety will in turn protect many individuals from harmful things digested and swallowed, used in personal care, and for other purposes.
I found an interesting article online pertaining to unregulated products and one of the things which stood out to me is that in some cases people tend to prefer unregulated products when looking for certain items that have lesser cost or purposes of use.
“Many clients don’t understand the significant differences between creating a regulated and unregulated product. Some of the differences are with security, and more easily prone to hackers, data and a product losing all credibility in the market. Also, unregulated products access, management and control factors., level of integration with other products to fulfill its potential for users, and the unregulated product approaches around early products take on more depth, meaning, and consequence when it comes to regulated products. It is easier in unregulated products to decide to care and do more about the factors listed above when there are more users. Regulated products don’t afford the same luxury of lack of attention to these areas. A regulated product needs to be constructed with much more thought and rigor than an unregulated product. Many companies wanting to create a regulated product will refer to unregulated products because those are the products they use personally and are the most familiar with. It’s a natural thing to do, but it is also misguided. Comparing a regulated product to an unregulated product is like comparing a certified architect to an uncle who likes to go to Home Depot but doesn’t know how anything should be built.” (Regulated Products).
I believe that by raising the awareness of biohacking and the detrimental effects and serious adverse events of acquiring and using unregulated products is very important to safety and efficacy. The importance of regulatory involvements is essential to saving human lives from harm, and it is my belief that is a good start to imposing new sanctions on unregulated DYI products.
References:
Frederick. R. (2022. March 31.). Regulated Products. Creating a Product in a Regulated Industry Has Significant Ramifications for Product Teams. Retrieved on, July 21, 2022, from, https://productcoalition.com/regulated-products-54d20707bd7cLinks to an external site.
Unregulated Products. CPSC.gov. Retrieved on, July 21, 2022, from, https://www.cpsc.gov/Regulations-Laws–Standards/U…
Latania
I had no idea that biohacking was something that the average person could or would attempt. It seems like such a crazy thought that someone would put something in their body without high-quality verified data. My first thought would be why, why someone would resort to this method of treatment. Is this because there is no current research occurring to find treatment for the disease process that is being attempted with biohacking? In the Schoonmaker (2018) article it is noted that much of the biohacking is occurring in the cognitive field. Are we currently researching the area of cognitive function with enough ferocity? There are many gaps in the field of clinical research and a quick literature search will prove that there is little research available for many disease processes.
I do not think that biohacking is an effective way to move clinical research forward because it can be very dangerous since there is no regulation of the products or processes. Additionally, the findings could not be generalized across the population. This growing field should be regulated due to the potential for harm to participants and also due to the potential for sparks of ingenuity that may occur from biohacking. The level of regulation should be determined by the level of risk of harm to the participants.
Reference-
Schoonmaker, A. (2018, January 11). Biohacking and the Strange Future it Brings. | SD Entertainer Magazine. SD Entertainer Magazine | Your Source for Everything San Diego. Retrieved July 24, 2022, from https://www.sdentertainer.com/lifestyle/biohacking-and-the-strange-future-it-brings/Links to an external site.
