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The Evolution of Anticancer Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
Finally, genetically engineered mouse (GEM) models have also been developed (Figure 2.8C). The genetic profile of these mice is altered such that one or several genes thought to be involved in transformation or malignancy are mutated, deleted, or overexpressed. Subsequently, the effect of altering these genes is studied over time, and therapeutic responses to novel therapies can be monitored in vivo. For example, the OncoMouseTM (or “Harvard Mouse”) is a type of laboratory mouse that has been genetically modified and previously commercialized. It carries an activated oncogene (i.e., v-Ha-ras under the control of the mouse mammary tumor virus promoter) which significantly increases its susceptibility to cancer. The rights to this invention were originally owned by DuPont, although the patent expired in 2005, meaning that the OncomouseTM model is now free for use by other parties (although “OncoMouseTM” is still a registered trademark). Similarly, “knock-out mice”, in which key genes have been deleted from their genomes, have been introduced. These models can be used to study, for example, the effect of deleting tumor suppressor genes.
The development of pharmaceutical hegemony
Published in Kevin Dew, Public Health, Personal Health and Pills, 2018
In 1910, the idea of the biological assay, a test performed to measure the biological activity of a drug or remedy, was suggested by American authors writing in the American Journal of Pharmacy. Biological activity relates to the potential therapeutic effect of a remedy or its potency. At this time it was suggested that the biological potency of digitalis (from the leaves of the foxglove) could be assessed by a ‘cat unit’, that is, how many leaves it took to kill a cat (Porter 1995). The goal of standardising the potency of a medication set off a train of more complicated standardising processes. This was a result of having to standardise all instruments and procedures in tests so there could be more certainty that comparisons between tests were reliable. With the cat unit, it was found that different cats varied in their tolerance for drugs; a better unit needed to be found. Today most animals used in drug testing are bred for that purpose and in some cases, as with the OncoMouse, are genetically modified to enhance their research utility. Standardising went beyond the animals for testing. Further standardising impacted upon laboratory procedures, so that all laboratory workers followed the same methods.
Introduction
Published in Tina Stevens, Stuart Newman, Biotech Juggernaut, 2019
The U.S. Supreme Court’s 1980 ruling in Chakrabarty approved the patenting of a genetically engineered oil-eating bacterium. In so doing, it paved the way for the patenting of living organisms and contributed to the private ownership of naturally occurring DNA sequences and cell types. The Court, upholding an earlier opinion of the U.S. Court of Customs and Patent Appeals that stated that bacteria are “more akin to inanimate chemical compositions . . . [than] to horses and honeybees and raspberries and roses” (Newman, 2003, pp. 439–440). It opened the door to patents on mice, cows, and pigs, some of these mammals containing introduced human genes. Included, too, were naturally occurring human cells as well as nonhuman mammals containing human cells. In the wake of Chakrabarty the U.S. Patent Commissioner issued a rule in 1987 stating that the Patent and Trademark Office, “now considers nonnaturally occurring, nonhuman, multicellular living organisms, including animals, to be patentable subject matter” (Newman, 2003, p. 440). The next year Harvard University was granted the first patent for a genetically engineered mammal. The “Oncomouse” was created to develop cancer at a much higher rate than that of its naturally occurring predecessor. In accordance with Chakrabarty, the Oncomouse and its offspring (Leder et al., 1986), though alive, were considered “compositions of matter” (one criterion for patentability). University of Michigan Professor of Public Policy, Shobita Parthasarathy succinctly characterized the impact of Chakrabarty in Patent Politics: Life Forms, Markets and the Public Interest in the United States and Europe: The United States has opened its doors wide to life-form patentability, famously allowing patents on “anything under the sun made by man” . . . And it has largely dismissed ethical, socio-economic, health, and environmental concerns, characterizing them as distractions in a domain focused on technical questions of novelty, utility, and inventiveness.(Parthasarathy, 2017, p. 2)
Non-Human Germline Interventions
Published in The American Journal of Bioethics, 2020
Revisions are common in the world of non-human germline intervention. The Harvard oncomouse—the first patented mammal—was revised to make it more susceptible to cancer; efforts are currently underway to revise genes of animals to make them better sources of organs for xenotransplantation (Gupta and Maurya 2018). More disturbingly, thanks to the advent of CRISPR technology, a number of new efforts at revision involve changes to plants and animals that are then supposed to be released into the wild. Multiple efforts are underway to use gene-drives to eradicate certain mosquito species, or to alter their biology, in order to attack mosquito-borne diseases such as dengue, Zika and course malaria. Residents of Nantucket have considered releasing genetically modified mice as a way to attack Lyme disease. Researchers are working to modify trees and plants and coral to make them more robust to environmental stressors such as bleaching and drought. These efforts raise a constellation of ethical issues, including 1) whether releasing such modified creatures into the wild will have unpredictable environmental effects, and 2) whether and through what mechanisms local communities can give consent to be in the pathway of such environmental experimentation (Kofler et al. 2018). Many agricultural animals are revised to increase their productivity (Fridovich-Kell and Diaz 2020). Pets and domestic animals are also being revised to change their character and appearance (Charo and Greely 2015; Shrock and Güell 2017).