BIOL 311-case study 1

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Binghamton University *

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Feb 20, 2024

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Case Study # 1 " The relationship of cell and molecular biology to medicine, business and bioethics " Introduction: One of the key themes of Biology 311 is the critical interplay between cell and molecular biology, medicine, business, patent law, federal regulatory agencies (e.g. FDA), military defense, bioethics, religion and many other aspects of our society that had little to no relationship to the world of cell and molecular biology as few as 10 to 15 years ago. The attached article originally appeared as the lead article in The Boston Globe on Sunday, August 23, 2015, and even now in 2024 is an excellent example of how changes in our society can affect many of the aforementioned themes. Below are questions related to this article as well as another one cited in the problem set on Moderna ’s development of the COVID -19 vaccine that demonstrates the critical interplay between academia and the pharmaceutical/biotechnology arena. Some are "factual" questions that can be easily found on the internet and elsewhere; while others are "position" or “opinion” questions meaning that there is no correct answer, but you are asked to state your own position on the matter. Future problem sets will also have opinion questions if the topic is appropriate. Finally, you should be aware that the Boston Globe author, Rebecca Robbins, approved our use of her article for a case study in Biology 311. The teaching assistants have the answer key which provides additional information that to date has not yet been covered in class that they may elect to discuss. In another article that follows the Boston Globe publication ( Most Advanced Synthetic Human Embryos Yet Spark Controversy ) was published in June, 2023, and is an excellent example of yet another theme that we will stress especially in the early portions of the lecture series. This theme is the following: Select cell and molecular biology technologies have advanced to the point where in many cases what we are doing in the laboratory today may be regarded as unethical or illegal and subject to federal regulation. This short two page article addresses recent advances in generating an artificial human embryo from stem cells. Questions numbers 9 and 10 address some of the points made in this article. You will receive full credit for this and future problem sets if you make a reasonable attempt at answering the questions even though in some cases your answers may be brief or inaccurate. Questions: 1. Define tissue engineering and explain how the device mentioned in the article is designed to work. Tissue engineering is the act of repairing, replacing, or regenerating dysfunctional tissues or organs to improve their functionality. The device mentioned in the article is called a neuro-spinal scaffold. It is a biodegradable, pourus cylinder that is implanted into a damaged spinal cord. The design is intended to provide a structure for viable nerve cells to attach to and allow new growth.

2. What is the major business or product focus of In Vivo Therapeutics? In Vivo Therapeutics major business focus is to get their product approved by the FDA so their product can be used outside of case studies. The company is also focusing on adapting the device so it can be applicable to less severe injuries. This adaptation would increase the number of viable patients. 3. What is a clinical trial and how does the FDA play a role in this mechanism? How might you find out what clinical trials are currently underway or enrolling patients? Finally, what is the difference between how Moderna’s and Pfizer’s COVID -19 vaccines were reviewed by the FDA versus nearly all other drugs and medical devices? A clinical trial is the first step in a new treatment being approved for medical use. It is a research study that individuals volunteer for, used to prove if the treatment is safe and effective in humans. The FDA will look at the research and either approve the treatment, or decline it for human use. They ensure the product is safe for human use. COVID-19 vaccines were reviewed differently by the FDA because of the immediate need for the vaccine. There was no time to hold a standard clinical trial, and an Emergency Use Authorization was put into use. This meant that the FDA looked at the risks and decided the need for the vaccine outweighed the potential risks. 4. Robert Langer, a faculty member at MIT's prestigious Whitehead Institute, is mentioned in the article. He is a member of the Scientific Advisory Board of In Vivo Therapeutics and has a long list of accomplishments. As a faculty member should he or others who are full time faculty members at any university or college have constraints on their contributions to and activity with biotechnology companies? How might you design a fair strategic plan that would allow university research faculty to translate their work into new medical devices or practices that have both commercial and medical potential? No, just because someone is a faculty member at a university does not mean they should have constraints on their contributions and activity within the biotechnology field. Often university faculty work within a biotechnology company as well. Applying constraints would limit what they can provide to the company, as well as what they can provide to their students. I would allow the faculty members to conduct clinical studies of their research, allowing them to have their work translated into the medical field if proven effective and safe by the FDA. 5. Speaking of Langer, how was Robert Langer and a connection to stem cells involved in Moderna’s creation of their COVID -19 vaccine? (The answer can be found in the following link: https://www.statnews.com/2020/11/10/the-story-of- mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid- vaccine-race/ )? Note that this article was published before Moderna’s vaccine received its Emergency Use Authorization but tells the story better than any other article.

Rossi discovered a way to cloak mRNA so it can enter a cell, and then make proteins within that cell to create stem cells. Robert Langer reviewed Rossi’s discovery on how to create stem cells, and realized it was much bigger than that. This new technology could be used to create new vaccines and drugs. This allowed Moderna to be created, just in time for the pandemic. 6. One of the questions presented by the Boston Globe article is whether a patient who is undergoing an experimental treatment should use social media to indicate his or her progress or lack thereof as well as having the right to buy stock in the company sponsoring the trial in which he or she is enrolled. What is your position on both of these matters? Should the government restrict the activity detailed in this article? If so, what should be the penalty/fine? Do you think that patients undergoing an experimental clinical trial such as the one described should be subjected to a confidentiality agreement? I believe that a patient undergoing a clinical trial should not use social media, for both the experimental trials accuracy as well as their well-being. The article mentions how Stracham and Fallis often receive harmful and accusing comments online. These comments can impact their mental health and can interfere with their recovery within the trial. Along with these harmful comments, they may also receive false hope through their platforms that may make them believe they are recovering when they really aren’t seeing any significant improvements. Patients should sign a waiver when they start the trial stating they will not post about their experiences within the trial to a platform of over 5,000 followers, and will risk fines up to $1,000 if they do so. As for stocks, patients should be allowed to invest in their company’s stock. Without their posts influencing the stock, there is no way they can influence their investment on their own. 7. In the case of Jesi Stracham, she did not sign up for this treatment; her parents enrolled her in the clinical trial while she was still under sedation in the hospital. This situation falls under the case of patient consent and medical proxies. Hypothetically, in the case that Stracham did not have a medical proxy, do you think that it would have been appropriate for someone, even her parents, to sign her up for the trial without her consent? Without medical peroxy, Stracham should not have been signed up for the trial. Clinical trials can have dangerous, unexpected outcomes. Because of this, I believe consent is more important than ever here. 8. While both Jesi Stracham and Jordan Fallis continued to post to their various social media outlets as a means of updating followers and garnering support, other interested parties, such as investors and medical professionals, were also watching their progress. This led to stock fluctuations in InVivo Therapeutics stock based on subjective interpretations of their recovery. In addition, complete strangers posted intrusive questions to Stracham and Fallis regarding other bodily functions and even going so far as to accuse them of influencing stock

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prices and trial results to their benefit. Do you think that the blame for the personal and corporate drama is with posts from Stracham and Fallis? Do you think that it is the public, whether medical professionals, stock analysts, or random strangers, who are responsible for the drama? Or do you think both sides involved are responsible in the events that occurred? I believe both sides are responsible for these events. Stracham and Fallis unknowingly created these stock fluctuations. This was not their intention, however they are ultimately responsible for the attention InVivo Theraputics received. However, the public, professionals, and stock analysts are the ones feeding into the patient's platforms and reacting to them. This reaction is what leads to the stock change. 9. The other news article that follows the In Vivo Therapeutics article ( Most Advanced Synthetic Human Embryos Yet Spark Controversy) focuses on a totally different theme of generating artificial human embryos in the laboratory. As you will learn in class this is using tissue engineering to make an “oganoid” – an artificial organ whose function is similar to a natural organ. Based on what is presented in the article what is the “14 day rule” and why is the reference to monkeys at the end of the article important to the possible future of this type of technology? The 14 day rule states that human embryos cannot be cultured within a lab over 14 days. This requires researchers use animal embryos to study embryonic development beyond 14 days. At the end of the article, it is said that an artificial monkey embryo, when placed in the uterus, could induce pregnancy. This embryo terminated soon after, but it is only a recent study. This could mean that artificial human embryos could hypothetically be placed in the uterus within 14 days, allowing them to develop further than before. 10. You will see cases presented in class where cell biology technology was/is being used for unethical purposes for which it wasn’t intended. This runs the gamut from genetically engineered human babies to companies offering stem cell therapy treatments that have no medical or scientific merit. Do you think this type of research developing stem cell generated, artificial human embryos should be regulated in the United States and if so, how would this regulation work? Stem cell human embryo research should be regulated in the United States. If this technology reaches the wrong hands, things like “designer babies” and other unnecessary modifications done to the embryo could arise. This type of technology should only be used in the case of life-threatening/altering diseases within embryos. The regulations should focus on what the intentions of the research are and shut down anything non-medical related.

BIOL 311-case study 1

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