Affirmative Updates - JDI 2024

Davis-Powers Affirmative Supplement + Answers
AFFIRMATIVE
UQ – Innovation Low Now
Innovation Low – Area Gap
There are many diseases that aren’t properly treated because of lack of incentive to innovate, causing millions of deaths.
Nwaka et al. 09, *Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland. **Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland. ***Swiss Tropical Institute, Basel, Switzerland. ****University of Antwerp, Antwerp, Belgium. *****Ewing Marion Kauffman Foundation, Kansas City, Missouri, United States of America. ******Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland. (*Solomon, **Bernadette Ramirez, ***Reto Brun, ****Louis Maes, *****Frank Douglas, ******Robert Ridley, 8/25/2009, “Advancing Drug Innovation for Neglected Diseases—Criteria for Lead Progression”, PLOS Neglected Tropical Diseases, https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0000440#ack)
Ideally, the interfaces between the various processes are well resourced and managed to ensure continuous availability of health products. Unfortunately, product research and development (R&D) and access is skewed in favour of ailments that are commercially attractive, while those diseases that disproportionately affect poor populations in developing countries are neglected. Consequently, an estimated 1 billion people, one in six of the world's population, currently suffer from neglected tropical diseases, mostly in developing countries [6]. The afflicted populations are poor and commercial incentives to enable investment in the risky product R&D are weak [3],[7]. The few available drugs have problems related to their cost, safety, stability, and increasingly, the threat of resistance that may limit their utility.
Some of the neglected diseases include malaria, trypanosomiasis, leishmaniasis, schistosomiasis, filariasis, and onchocerciasis. Malaria is a major health problem with over 1 million deaths occurring mainly in children and pregnant women in sub-Saharan Africa [8],[9]. New and affordable antimalarial drugs that are effective against resistant parasites and can be safely administered to children and pregnant women are urgently needed [3],[10]. Even for malaria, which has probably had significant investment, the drugs expected from the existing R&D portfolio in the next few years are a combination of old drugs that are mostly reliant on artemisinins. Going by the industrial assessment of attrition, the number of projects in the pre-clinical phase of R&D is too small to guarantee success. Recent reports of artemisinin resistance in Asia [11] means that emphasis has to be placed on the discovery of novel entities to support the medium to long-term needs of malaria control as well as possible elimination and eradication. The ongoing discussion on malaria eradication requires major technical and financial investment today to support the discovery and development of the tools needed for eradication beyond the next 15 years.
Innovation Low – Post-COVID
More innovation and preparedness is required, even after COVID
Durugbo et al. ‘22, Durugbo is currently an Associate Professor, and the Head of the Innovation and Technology Management Department, Soud almahamid. Professor at Arabian Gulf University. Arabian Gulf University ... P.h.d Management Information Systems, Lulwa H. Budalamah holds a PhD in Innovation Management from the Arabian. Professor Odeh Al-Jayyousi is the head of Technology and Innovation Management at the Arabian Gulf University in Bahrain, Batoul Bendimerad. Service Delivery Manager at National Aviation Services. National Aviation Services Maastricht Business school.( Christopher M.Durugbo, Sound M. Almahamid, Lulwa H. Budalamah, Odeh R. Al-Jayyousi and Batoul Bendimerad, 2022, “ Preparedness for Innovation in time of crisis: lessons from initial covid-19pandemic response, https://www.worldscientific.com/doi/full/10.1142/S0219877021400125) Coronavirus2 Disease 2019 (COVID-19) is a pandemic, i.e. a worldwide disease outbreak, and medical emergency that poses a unique crisis-driven context for innovation. Although medical knowledge on the clinical presentation, epidemiology, treatment, and prognosis continues to emerge and evolve [Sohrabi et al. (2020); Shah and Farrow (2020)], there is limited scientific knowledge on preparedness for the COVID-19 response in innovation management (IM) contexts. Furthermore, IM scholars [Brem et al. (2021)] note that pandemics will likely affect humanity again and argue that future crises could benefit from current knowledge acquired during innovation processes triggered by COVID-19. While related studies discuss framings of technological and service innovations accelerated by COVID-19 [Woolliscroft (2020); Heinonen and Strandvik (2020); Azoulay and Jones (2020); Brem et al. (2021)], an analysis of the literature suggests paucity on research concerning preparedness strategies for the initial response to COVID-19, in an IM context. With researchers and practitioners worldwide reflecting on future challenges of a post-COVID era [Dey et al. (2020); Chesbrough (2020)], there is a need to learn lessons on the nuances and niceties of preparedness strategies adopted by organizations for confronting the pandemic. This premise is the motivation for our study. The main objective here is not to revisit or engage in the discourse and debate on the epidemiology of COVID-19 or the soundness, effectiveness, or efficiency of the crisis response, but rather examine the IM lessons learnt on preparedness for mitigating the transmission and spread of COVID-19.Due to the impact of COVID-19, some researchers [Azoulay and Jones (2020)] argue that responses in the form of innovative healthcare solutions such as vaccines and therapies, driven by open innovation [Chesbrough (2020)] are crucial for recovery,Innovativeness in times of crisis emanates from both concepts [Pearson and Mitroff (1993); Bessant et al. (2015)] and shapes the effective management of crisis situations in the form of ad hoc decisions, customized solutions or thoroughly planned and prepared approaches based on prior experiences and knowledge of subject matter experts. Furthermore, the stakes in preparedness tend to be higher because lack of preparation increases potentials for paralysis i.e. situations in which pressures overwhelm decision makers rendering them incapable of taking decisive action [Rosenthal et al. (2001)]. Thus, managing crisis entails preparedness to innovate for averting or containing disasters and emergencies.
! Ext. – Bioterrorism
Bioterror is feasible and causes extinction.
Walsh 19, Bryan Walsh has a BA from Princeton University, He worked at Time magazine for 15 years as a foreign correspondent in Hong Kong and Tokyo, an environment writer, and as international editor, the Future Correspondent for Axios, Editor of the Science and Technology Publication OneZero, Former Senior and International Editor at Time Magazine, is an editorial director at Vox overseeing the tech, climate, and world teams, as well as the editor of Vox’ Future Perfect section. (Bryan, August 27, End Times: A Brief Guide to the End of the World, Hatchet Books, Chapter 6, pp. 204-206)
I’ve lived through disease outbreaks, and in the previous chapter I showed just how unprepared we are to face a widespread pandemic of flu or another new pathogen like SARS. But a deliberate outbreak caused by an engineered pathogen would be far worse. We would face the same agonizing decisions that must be made during a natural pandemic: whether to ban travel from affected regions, how to keep overburdened hospitals working as the rolls of the sick grew, how to accelerate the development and distribution of vaccines and drugs. To that dire list add the terror that would spread once it became clear that the death and disease in our midst was not the random work of nature, but a deliberate act of malice. We’re scared of disease outbreaks and we’re scared of terrorism—put them together and you have a formula for chaos.
As deadly and as disruptive as a conventional bioterror incident would be, an attack that employed existing pathogens could only spread so far, limited by the same laws of evolution that circumscribe natural disease outbreaks. But a virus engineered in a lab to break those laws could spread faster and kill quicker than anything that would emerge out of nature. It can be designed to evade medical countermeasures, frustrating doctors’ attempts to diagnose cases and treat patients. If health officials manage to stamp out the outbreak, it could be reintroduced into the public again and again. It could, with the right mix of genetic traits, even wipe us off the planet, making engineered viruses a genuine existential threat.
And such an attack may not even be that difficult to carry out. Thanks to advances in biotechnology that have rapidly reduced the skill level and funding needed to perform gene editing and engineering, what might have once required the work of an army of virologists employed by a nation-state could soon be done by a handful of talented and trained individuals. Or maybe just one.
When Melinda Gates was asked at the South by Southwest conference in 2018 to identify what she saw as the biggest threat facing the world over the next decade, she didn’t hesitate: “A bioterrorism event. Definitely.”2
She’s far from alone. In 2016, President Obama’s director of national intelligence James Clapper identified CRISPR as a “weapon of mass destruction,” a category usually reserved for known nightmares like nuclear bombs and chemical weapons. A 2018 report from the National Academies of Sciences concluded that biotechnology had rewritten what was possible in creating new weapons, while also increasing the range of people capable of carrying out such attacks.3 That’s a fatal combination, one that plausibly threatens the future of humanity like nothing else.
“The existential threat that would be most available for someone, if they felt like doing something, would be a bioweapon,” said Eric Klien, founder of the Lifeboat Foundation, a nonprofit dedicated to helping humanity survive existential risks. “It would not be hard for a small group of people, maybe even just two or three people, to kill a hundred million people using a bioweapon. There are probably a million people currently on the planet who would have the technical knowledge to pull this off. It’s actually surprising that it hasn’t happened yet.”
Government agencies consider bioterror a real threat.
Emmeluth 20, Professor of Microbiology at Savannah Technical College, Professor of Bioethics, Biology & Education at Armstrong Atlantic State University, Ed.S. and Ed.D. from Florida Atlantic University. (Donald, 2020, Botulism: Third Edition, Facts On File, https://online.infobase.com/HRC/Search/Details/11?articleId=394253&q=bioterror)
The National Institute of Allergy and Infectious Diseases (NIAID) is part of the U.S. Department of Health and Human Services. Because bioterrorism continues to be a real concern for the United States, NIAID and other agencies have accelerated microbial research and development of diagnostic, preventive, and treatment methods. Microbial genomics has become an important part of this overall approach. Genomics refers to being able to identify and utilize the totality of genetic information found in an organism. This complete collection of an organism's genetic information is known as its genome. Understanding an organism's genetic program may aid in understanding how an organism carries out its biochemical and physical processing and operates as a complex biological system.
According to the National Institutes of Health (NIH), this genetic information is used to develop gene-based diagnostic and sampling tests to quickly detect dangerous germs and assess their susceptibility to different types of treatment. Genomes also provide molecular fingerprints of different strains of a given microbe, thereby enabling investigators to better track future outbreaks to their source.
In May 2004, the Sanger Institute completed the sequence of the genome of C.botulinum in collaboration with Dr. Roger Huston of the University of Reading, Dr. Nigel Minton of the University of Nottingham, and Dr. M. Peck of the Institute of Food Research.
NIAID Research Against Bacterial Products
NIAID is involved in both long- and short-term biodefense research studies to find ways to deal with infectious microbial diseases caused by microbial toxins. Toxins that have potential use as bioterror agents are particularly highlighted. A major part of the research is to develop FDA-approved vaccines, treatments, and diagnostic tests that could be used as part of a defensive package against these bioterror agents. The research goals of NIAID for botulism include developing an enhanced package of antitoxins for the treatment of botulism, a vaccine that will be effective against all seven types of botulinum toxins, and better methods of detecting and diagnosing the illness.
Bioterror is very likely and causes extinction
Pedersen ‘17— Public Policy Analysist at Pepperdine University ( Christian 7/20/17, “Reflecting Back on the Ebola Outbreak and the Future of Bioterrorism”, Pepperdine University, https://digitalcommons.pepperdine.edu/cgi/viewcontent.cgi?article=1132&context=ppr)
Terror groups like al-Qaeda and ISIL (the Islamic State of Iraq and the Levant) have expressed interested, and have even attempted, to use biological agents in terror plots (Biodefense, 2016). The technical and administrative knowledge of biology and chemistry can be acquired globally in medical schools, research programs, and laboratories, making it difficult to prevent potential practitioners of bioterrorism from acquiring the required scientific knowledge (Chiodo, 2015). While at one time the ability to mutate strands was restricted to advanced research laboratories, rudimentary high school laboratories now have the ability to develop deadly biological agents (Garrett, 2012). With relative easy, terror groups could engineer the flu virus, making it deadlier (Selk, 2017). By combining traits of multiple strains and maximizing the virus’ natural properties, it could become highly transmittable (Farmer, 2107). Genetically engineered viruses have the potential to kill more people than nuclear weapons, governments remain underprepared for that threat (Selk, 2017).
Terrorists could be drawn to the use of biological agents because of the difficulty of detection and the ease at which some biological agents can naturally spread through a population (Bioterrorism, 2006). There are essentially three ways which agents could be acquired by terrorist: they could be stolen, created in laboratory environments, or collected naturally. A gloomy reality is that as the advancement of new technologies reduce the costs of genetic sequencing, it will become easier and less expensive to create novel organisms (Garrett, 2012). Bioterrorist attacks can be planned to induce maximum damage and panic with a minimum risk of early detection. Potential agents of attack are categorized by risk (rated as an, A, B, or a C) depending on the agent’s availability, ease of dissemination and transmission, and potential impact (Bioterrorism, 2006). Category A agents are considered the most dangerous and threatening to National Security. Ebola is categorized as a Category A bioagent because of its ability to cause mass panic and disruption and the special public health actions required for treating those infected.
Bioterror causes extinction
Gottlieb 13. (Scott Gottlieb, MD, physician and a Resident Fellow at the American Enterprise Institute in Washington. Former FDA Deputy Commissioner and expert on medical tech and innovation. (Scott 4/17/13, “Ricin and the Risk of Bioterror; Are We Prepared”, Forbes, physician and a Resident Fellow at the American Enterprise Institute in Washington, https://www.forbes.com/sites/scottgottlieb/2013/04/17/ricin-domestic-bioterrorism-and-the-lessons-learned-after-9-11-are-we-safer-today-than-we-were-ten-years-ago/)
The ghastly bombings in Boston followed by envelopes laced with the lethal poison ricin that were sent to the U.S Capitol and the White House, renew fears about our vulnerability to these kinds of terrorist acts. It invites unwelcome memories of 9-11. Speculation is widespread about the potential origins of these attacks, and whether they could be related (seems unlikely). Investigations are underway and a suspect in the ricin attacks is now in custody. In time, we also must ask how much safer we’ve made ourselves based on the lessons we learned after 9-11. And whether there are still precautions we should heed. When it comes to bioterrorism, it’s a mixed bag. Programs enacted after 9-11 helped shore up our defenses. But in their current form, they're not as well equipped to promote development of the kinds of technologies that we need to thwart modern day threats. These threats may not come from established agents of bioterror, but new strains of bugs engineered for deadly purposes. Programs were started after 9-11 to underwrite the federal development of medical countermeasures. The centerpiece of the effort was Project Bioshield. Congress passed the Bioshield Act in 2004. Its aim was to fund the purchase of vaccines and treatments aimed at thwarting bioterrorism. A key element of the Act was to allow stockpiling of countermeasures. Some of these agents would be approved for government purchase based on testing in animals alone. It’s not feasible to infect people with deadly bugs like smallpox just to enable human testing. You can Follow Dr. Scott Gottlieb on Twitter @ScottGottliebMD Since the 2001 anthrax attacks, the feds have allocated nearly $50 billion to address the threat of biological weapons. A lot of the funding also goes to Biomedical Advanced Research and Development Authority (BARDA), established in 2006 to help companies through the mid (and high risk) stages of drug development. BARDA is part of the Department of Health and Human Services. It provides funding through contracts to mostly mid and later-stage efforts to develop new types of countermeasures. But the government’s foray into this sort of venture investing has been bumpy. The Bioshield and BARDA funding has proven useful for scaling up the manufacture of vaccines and other countermeasures that were already in advanced stages of development, but needed additional money to make their manufacture economically feasible or possible in the first place. But these programs have been less successful at financing early stage ventures aimed at developing completely novel agents. It hasn't really been their mission. For one thing, taking on the kind of risk inherent in the early stages of drug development is not an exercise well suited to government work, where political pressures often cause an aversion to risk taking. Some government programs, like the Defense Advanced Research Projects Agency (DARPA) have success at financing innovative, early ventures. But they tolerate a lot of failures along the way. Over the past decade, BARDA and Bioshield have not been so lucky. The intense political scrutiny that these efforts have undergone (often stoked by companies that lose out on contracts and complain to Congress) has made the government executives managing the programs understandably skittish. This has rendered the entire process adverse to the kind of risk taking that’s required for successful drug discovery. A better approach to stimulating development of the kinds of countermeasures we need to thwart future threats may be a prize-based system. This isn’t a new idea. It’s been long advocated by left-leaning policy analysts and critics of pharmaceutical patent

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