Eli Lilly and Co. and the Salk Polio Vaccine
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Preliminary Injunction
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA INDIANAPOLIS DIVISION ELI LILLY AND COMPANY, et al. ) ) Plaintiffs, ) ) v. ) No. 1:21-cv-00081-SEB-MJD ) NORRIS COCHRAN, et al. ) ) Defendants. ) ORDER GRANTING PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION This cause is before the Court on Plaintiffs' Motion for Preliminary Injunction [Dkt. 18], filed on January 25, 2021. Plaintiffs Eli Lilly and Company and Lilly USA, LLC (collectively, "Plaintiffs" or "Lilly") seek to have Defendants Norris Cochran, in his official capacity as Acting Secretary of Health and Human Services, Daniel J. Barry, in his official capacity as Acting General Counsel of Health and Human Services, United States Department of Health and Human Services, Diana Espinosa, in her official capacity as Acting Administrator of Health Resources and Services Administration, and Health Resources and Services Administration (collectively, "Defendants") enjoined from implementing or enforcing against Plaintiffs the Administrative Dispute Resolution Regulation published at 85 Fed. Reg. 80,632 and codified at 42 C.F.R. §§ 10.20-24 ("ADR Rule"), which sets forth the administrative dispute resolution process for certain disputes regarding the 340B Drug Pricing Program, established by § 340B of the Public Service Act, 42 U.S.C. § 256b. 1 The Court heard arguments on February 26, 2021. Having now considered those arguments, along with the parties' evidentiary and written submissions, the amicus brief, and the controlling principles of law, we hereby GRANT Plaintiffs' Motion -
For Schools and Parents: K-12 Immunization Requirements
FOR SCHOOLS AND PARENTS: K-12 IMMUNIZATION REQUIREMENTS NJ Department of Health (NJDOH) Vaccine Preventable Disease Program Summary of NJ School Immunization Requirements Listed in the chart below are the minimum required number of doses your child must have to attend a NJ school.* This is strictly a summary document. Exceptions to these requirements (i.e. provisional admission, grace periods, and exemptions) are specified in the Immunization of Pupils in School rules, New Jersey Administrative Code (N.J.A.C. 8:57-4). Please reference the administrative rules for more details https://www.nj.gov/health/cd/imm_requirements/acode/. Additional vaccines are recommended by Advisory Committee on Immunization Practices (ACIP) for optimal protection. For the complete ACIP Recommended Immunization Schedule, please visit http://www.cdc.gov/vaccines/schedules/index.html. Minimum Number of Doses for Each Vaccine Grade/level child DTaP Polio MMR Varicella Hepatitis Meningococcal Tdap enters school: Diphtheria, Tetanus, acellular Pertussis Inactivated (Measles, (Chickenpox) B (Tetanus, Polio Vaccine Mumps, diphtheria, (IPV) Rubella) acellular pertussis) § | Kindergarten – A total of 4 doses with one of these doses A total of 3 2 doses 1 dose 3 doses None None 1st grade on or after the 4th birthday doses with one OR any 5 doses† of these doses given on or after the 4th birthday ‡ OR any 4 doses nd th † 2 – 5 grade 3 doses 3 doses 2 doses 1 dose 3 doses None See footnote NOTE: Children 7 years of age and older, who have not been previously vaccinated with the primary DTaP series, should receive 3 doses of Td. -
Good, Bad and Ugly: the History of Polio Vaccines Transcript
Good, Bad and Ugly: The History of Polio Vaccines Transcript Date: Thursday, 12 June 2014 - 1:00PM Location: Barnard's Inn Hall 12 June 2014 Good, Bad and Ugly: The History of Polio Vaccines Professor Gareth Williams The main villain of the piece is the poliovirus, one of the smallest and simplest viruses. It is usually spread by the faecal-oral route (dirty fingers!) and in most cases is confined to the gut. As travels down the intestine, it induces antibodies (immunity) against itself, which will protect the person against future attacks by the virus. In about 1% of cases, the virus floods into the bloodstream and infects the nerve cells in the spinal cord which drive the muscles. This causes the characteristic paralysis, which can affect one or more limbs and/or the muscles of respiration – in which case artificial ventilation (e.g. with the iron lung) may be needed to keep the patient breathing and alive. Polio originally caused sporadic clusters of paralysis, especially in children. For some reason, this pattern changed during the late 19th century into explosive epidemics which swept through many countries each summer. The first major outbreak, on the East Coast of the USA in the summer of 1916, caused 25,000 cases of paralysis and 6,000 deaths. Draconian public health measures were powerless to prevent the spread of polio, resulting in widespread panic across America. Each year, panic resurfaced as the polio season approached, with the wealthy leaving towns and cities in droves. During the early 1950s, Americans feared polio almost as much as the atom bomb. -
A Guide to Preparing Multiple Choice Items
A Guide to Preparing Multiple Choice Items Introduction The most commonly used type of test item in admissions, certification, and licensure examinations is the multiple choice item. The purpose of this guide is to assist test developers and representatives of professional associations in becoming more skilled in writing multiple choice test items. Preparing multiple choice items may appear on the surface to be a relatively simple task, given familiarity with the subject matter. However, experienced test authors find that this task actually requires a great deal of skill, patience, and creativity. In the sections that follow, general knowledge is used as the content of the examples, in order to facilitate understanding of the principles by professionals from diverse content areas. The skills needed for writing quality items are similar regardless of content discipline. Like any other skill, multiple choice item writing requires a significant amount of painstaking practice with appropriate feedback. It is essential that you try out your multiple choice items on others. This process will help you to uncover ambiguities in wording and unintended violations of item writing principles. Feedback from others will greatly enhance your item writing quality and productivity. Parts of the Multiple Choice Item All multiple choice items consist of two basic parts: the stem and the responses. The stem is the introductory statement or question that elicits the correct answer. The responses are suggested answers which complete the statement or answer the question asked in the stem, only one of which is the correct answer. In the examples that follow, four responses (i.e., 1 correct response and 3 incorrect responses) are presented. -
Jonas Salk at the National Press Club, April 12, 1965
Jonas Salk at the National Press Club, April 12, 1965 Jonas Salk, May 1962. A.F.P. – D.P.A. Photos. National Press Club Archives On the tenth anniversary of the licensing of the polio vaccine he developed, Dr. Jonas E. Salk (1914-1995) visited Washington to accept a joint congressional resolution that hailed the vaccine as “one of the most significant medical achievements of our time.” At the White House, President Johnson offered Salk his congratulations. The day also marked the twentieth anniversary of the death of former President Franklin D. Roosevelt, who, having suffered from paralytic polio since 1921, had established the foundation that funded Salk’s efforts. Following his meetings with Congress and the President, Salk gave a talk and answered reporters’ questions at a National Press Club luncheon. In the title of its lead editorial ten years earlier celebrating the successful testing of the new vaccine, the New York Times proclaimed the “Dawn of a New Medical Day.” Testing of the vaccine, like the funding for its development, had engaged the participation of millions of ordinary American citizens. Through March of Dimes campaigns, hundreds of thousands of volunteers went door-to-door raising $41 million in 1952 alone from average donations of 27 cents. The tests involved 1.8 million school children, 200,000 volunteers, 64,000 teachers, and 60,000 physicians, nurses, and health officials, making it the largest clinical trial in history. Interpreting the jubilant 1 reaction to news that the vaccine had been proven safe and effective, the Times commented, “Gone are the old helplessness, the fear of an invisible enemy, the frustration of physicians.” Poliomyelitis, also known as infantile paralysis, is an extremely contagious viral infection caused by any of three types of poliovirus. -
Poliomyelitis in the Lone Star State
POLIOMYELITIS IN THE LONE STAR STATE: A BRIEF EXAMINATION IN RURAL AND URBAN COMMUNITIES THESIS Presented to the Graduate Council of Texas State University in Partial Fulfillment of the Requirements For the Degree Master of Arts By Jason C. Lee San Marcos, Texas December, 2005 Insert signature page here ii COPYRIGHT By Jason Chu Lee 2005 iii ACKNOWLEDGEMENTS It leaves me in a stupor to contemplate all those I have to thank for aiding me in this effort. If I leave anybody out, please accept my most humble apologies, as the list is long. I will be the first to admit that this work is flawed, despite the best efforts of my committee to save me from myself. Had I utilized them more, this piece would only be improved. I had never undertaken a project of this scope before and though I believe I have accomplished much, the experience has been humbling. Never again will I utter the phrase, “just a thesis.” My biggest thanks go out to Dr. Mary Brennan, my committee chair and mentor. Without her guidance I most certainly would have needed to take comprehensive finals to graduate. She helped me salvage weeks of research that I thought had no discernable use. But Dr. Brennan, despite her very, very busy schedule with the department and her family, still found the time to help me find my thesis in all the data. She is well loved in the department for obvious reasons, as she has a gift for being firm and professional while remaining compassionate. Dr. James Wilson and Dr. -
Polio Vaccine May Be Given at the Same Time As Other Paralysis (Can’T Move Arm Or Leg)
POLIO VVPOLIO AAACCINECCINECCINE (_________ W H A T Y O U N E E D T O K N O W ) (_I111 ________What is polio? ) (_I ________Who should get polio ) 333 vaccine and when? Polio is a disease caused by a virus. It enters a child’s (or adult’s) body through the mouth. Sometimes it does IPV is a shot, given in the leg or arm, depending on age. not cause serious illness. But sometimes it causes Polio vaccine may be given at the same time as other paralysis (can’t move arm or leg). It can kill people who vaccines. get it, usually by paralyzing the muscles that help them Children breathe. Most people should get polio vaccine when they are Polio used to be very common in the United States. It children. Children get 4 doses of IPV, at these ages: paralyzed and killed thousands of people a year before we 333 A dose at 2 months 333 A dose at 6-18 months had a vaccine for it. 333 A dose at 4 months 333 A booster dose at 4-6 years 222 Why get vaccinated? ) Adults c I Most adults do not need polio vaccine because they were Inactivated Polio Vaccine (IPV) can prevent polio. already vaccinated as children. But three groups of adults are at higher risk and should consider polio vaccination: History: A 1916 polio epidemic in the United States killed (1) people traveling to areas of the world where polio is 6,000 people and paralyzed 27,000 more. In the early common, 1950’s there were more than 20,000 cases of polio each (2) laboratory workers who might handle polio virus, and year. -
Vaccine Symposium Louis Pasteur As Pioneers Who Fundamentally Changed the Nature of Presented by the MSU Department of Microbiology & Immunology Human Health
Maurice Hilleman, 1919-2005, was a 1941 MSU graduate who saved the lives of millions by developing a wide array of vaccines. nd 2 Maurice Hilleman A Miles City native, Hilleman graduated atop his class at what was then Montana State College with dual degrees in chemistry and microbiology. His name often accompanies those of Jonas Salk and Vaccine Symposium Louis Pasteur as pioneers who fundamentally changed the nature of Presented by the MSU Department of Microbiology & Immunology human health. The abstract on a National Institutes of Health obituary for Hilleman describes him this way: "Microbe hunter, pioneering virologist, and the world's leading vaccinologist." Mi Among Hilleman's scientific achievements: • A hepatitis B vaccine that was the first vaccine to prevent a cancer in humans (liver cancer, or hepatoma). • A measles-mumps-and-rubella combination vaccine chat marked the first time vaccines for different viruses were successfully combined in a single shot. • Vaccines for meningitis and pneumonia. • A mumps vaccine that came after Hilleman isolated the virus by swabbing the back of his daughter Jeryl Lynn's throat when she was stricken with the disease (50 years later it is still the basis for most mumps vaccines). • A more complete understanding of the ways different strains of the flu change slightly from year to year, which led to the practice of developing an annual seasonal flu vaccine. • The first successful prediction of a coming influenza pandemic and development of a vaccine that thwarted it, 2018 possibly saving close to a million people in 1957. Indeed, Hilleman was responsible for developing 8 out of the 14 recommended vaccinations today. -
Eli Lilly and Company
Merrimack College Merrimack ScholarWorks Honors Senior Capstone Projects Honors Program Spring 2021 Eli Lilly and Company Alyssa Ardai Follow this and additional works at: https://scholarworks.merrimack.edu/honors_capstones Part of the Business Commons Ardai 1 Written Assignment #4 Eli Lilly and Company Alyssa Ardai Bus 4402W: Strategic Analysis and Decision Making Professor Herrmann April 30, 2021 Ardai 2 Abstract Eli Lilly and Company is a pharmaceutical company that has the goal of creating new products. Eli Lilly’s products are seen in hospitals and pharmacies around the US, with the hopes of growing internationally. By having a large number of drugs in their pipeline, they can be a key player in improving multiple types of illnesses as well as help aid the aging population. The healthcare sector is always one that is high-performing. Ardai 3 Eli Lilly and Company is positioned as a pharmaceutical company, with the goal of creating high-quality medicine for every need or to take a preexisting medicine and make it better. For the past 140 years, they have been creating medicine for various causes, but are now focusing their efforts on antibody treatments for the COVID-19 pandemic, as well as different cancers and autoimmune diseases. Everything that the company does should follow its core values: integrity, excellence, and respect for people (Eli Lilly and Company - A). Eli Lilly is found in the US, Japan, Europe, and hopes to expand to the rest of the world soon. They are broken down into Endocrinology, Oncology, Immunology, Neuroscience, & Other. The company has increased revenues from $23,832.8 - $25,925.3, a consistent tax rate of 15%, expenses increasing $300k a year, accounts receivable, or a/r, decreasing as they pay less in patents and drugs go generic, consistent inventory of $120k - $140k, showing they do not keep a lot on hand, a weighted average cost of capital, or WACC, of 5.9% showing it does not hold a lot of debt, and a long term growth rate of 2.3%, showing a healthy but stable growth (Bloomberg LP, CapitalIQ 2021). -
Swine Flu and Polio Vaccines: Some Parallels and Some Differences
Swine Fluand Polio Vaccines: Some Parallelsand Some Differences Howard B. Baumel College of Staten Island of the City Universityof New York Staten Island 10301 The swine flu vaccinationprogram vaccine could be successfullydevel- facturedby a single pharmaceutical generated debate in scientific and oped. company.The cause of this outbreak medical circlesthat extended to the Salkrelied heavily on his previous was never clearly established. Be- Downloaded from http://online.ucpress.edu/abt/article-pdf/39/9/550/36038/4446085.pdf by guest on 29 September 2021 general public.The controversythat experience as he attemptedto pro- cause bottles of tissue culture fluid centered on the vaccine's effective- duce a killedvirus polio vaccine.He containingthe virushad been stored ness and safety was reminiscentof used formalinto kill the virus and priorto being treated with formalin, the problemsthat accompaniedthe isolated one strain for each of the it was possiblethat bits of tissue had development of the polio vaccine three knowntypes of polio virus.To settled to the bottom covering the years ago. A review of that earlier determineif any live virusremained viruses and protecting them from scientific achievement can provide after the exposure to formalin,the the formalin.To prevent this, the insightsinto the swineflu dilemma. treated virus was injected into the tissue culture fluid was filtered to By the mid-1930's,only threeviral brain of a monkey. If the monkey remove the debris before exposure diseases,smallpox, rabies, and yellow contracted polio, it was concluded to formalin. fever, had yielded to vaccines. In that live viruswas present.To deter- HeraldCox and HilaryKoprowski each of these cases, the vaccine mine if the treated virus was effec- (1955, 1956) had developed an consisted of a live virus. -
Polio Fact Sheet
Polio Fact Sheet 1. What is Polio? - Polio is a disease caused by a virus that lives in the human throat and intestinal tract. It is spread by exposure to infected human stool: e.g. from poor sanitation practices. The 1952 Polio epidemic was the worst outbreak in the nation's history. Of nearly 58,000 cases reported that year, 3,145 people died and 21,269 were left with mild to disabling paralysis, with most of the victims being children. The "public reaction was to a plague", said historian William O'Neill. "Citizens of urban areas were to be terrified every summer when this frightful visitor returned.” A Polio vaccine first became available in 1955. 2. What are the symptoms of Polio? - Up to 95 % of people infected with Polio virus are not aware they are infected, but can still transmit it to others. While some develop just a fever, sore throat, upset stomach, and/or flu-like symptoms and have no paralysis or other serious symptoms, others get a stiffness of the back or legs, and experience increased sensitivity. However, a few develop life-threatening paralysis of muscles. The risk of developing serious symptoms increases with the age of the ill person. 3. Is Polio still a disease seen in the United States? - The last naturally occurring cases of Polio in the United States were in 1979, when an outbreak occurred among the Amish in several states including Pennsylvania. 4. What kinds of Polio vaccines are used in the United States? - There is now only one kind of Polio vaccine used in the United States: the Inactivated Polio vaccine (IPV) is given as an injection (shot). -
Re-Thinking Pandemics: State, Society, and Disease in British History, 1830-1960
Providence College DigitalCommons@Providence History & Classics Undergraduate Theses History & Classics Spring 2021 Re-thinking Pandemics: State, Society, and Disease in British History, 1830-1960 Meghan Walsh Follow this and additional works at: https://digitalcommons.providence.edu/history_undergrad_theses Part of the European History Commons, and the History of Science, Technology, and Medicine Commons Re-thinking Pandemics: State, Society, and Disease in British History, 1830-1960 by Meghan Walsh HIS 490 History Honors Thesis Department of History and Classics Providence College Spring 2021 This thesis is dedicated to the 3 million people who lost their lives to COVID-19 and to all the frontline workers and essential employees, without whom nothing would be possible. “Epidemics all follow this similar arc where people deny or dismiss the threat until it becomes impossible to ignore any more,” - Mark Honigsbaum, medical historian at City, University of London CONTENTS ACKNOWLEDGEMENTS………………………………………………………………………vi INTRODUCTION …………………………………………...……………………………………1 CHAPTER 1: THE STORY OF CHOLERA ……………………………………………………..8 CHAPTER 2: IGNORING INFLUENZA………………………………………………………..23 CHAPTER 3: TREATING POLIO ……………………………………………………………...36 CONCLUSION: HOW THINGS HAVE CHANGED…………………………………………...54 BIBLIOGRAPHY.........………………………………………………………………………….59 v ACKNOWLEDGEMENTS A project this size truly takes a village, and I am eternally grateful to mine for seeing me through to the end of this. Researching and immersing myself in the lives and experiences of British citizens from three major pandemics, whilst living in one, was an interesting journey, but several people ensured I never went on it alone. To Dr. Smith and Dr. Murphy, thank you for making this possible and for granting me the opportunity to write a senior thesis. Your comments, guidance and encouragement were invaluable.