Pharma Core - Michigan 7 2024 BFHR
Pharma Core - Michigan 7 2024 BFHR.docx
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The note (put in calibri bc my email wouldn’t plsssssss): Thank you to Gabby, Hannah, Jimin, Kavi, and Reagan for all the hard work on this file!!! And a special thank you to Jimin for joining us as a substitute lab leader! This file is an impact turn to those that say they help or hurt big pharma such as but not limited to the Waivers aff and anything about Bayh Dole. There are a few essential back-and-forths: Are high drug prices key to pharma innovation? Are high drug prices inflationary? Do high drug prices resolve HIV? Is big pharma ethical? A large portion of those claims about high drug prices are on the question of funding. Specifically, some claim that the profits go to inefficient means or that government funding is sufficient while others describe high drug prices and patents as key to secondary innovation and profits. The ethics claims are mostly about drug trials and more specifically those about if they’re run properly. Some further avenues to explore may be those of developing nations, specific illnesses outside of HIV and pandemics, and big pharma lawsuits against small companies. With love, Reagan <3 Pharma Core Pharma Good 2NC---Internal---Inflation That causes inflation. Cubanski & Neuman 22 [Juliette; Deputy director of the Program on Medicare Policy with degrees from UCLA and UC Berkely; Tricia; senior vice president of KFF and executive director of its Program on Medicare Policy with a doctorate from the Johns Hopkins School of Public Health; 2/25/2022; KFF; “Prices Increased Faster Than Inflation for Half of all Drugs Covered by Medicare in 2020”; https://www.kff.org/medicare/issue-brief/prices-increased-faster-than-inflation-for-half-of-all-drugs-covered-by-medicare-in-2020/]//kaviWaRu Annual increases in drug price increases can translate to higher Medicare spending and higher out-of-pocket drug costs by patients. Higher out-of-pocket spending occurs when beneficiaries are required to pay coinsurance, or a percent of the drug’s price – which is common for many brand-name Part D drugs and standard for all Part B covered drugs in the form of a 20% coinsurance requirement. 2NC---AT: Key to Solve Disease High drug prices worsen disease---people can’t afford and refuse to take the medication. Gordon 5/18 [Sherri; She is an author and journalist covering health and wellness with a Certificate of completion from Ohio State's Patient and Community Peer Review Academy; 5/18/2024; Health; “CDC Report: 9 Million Americans Not Taking Medications as Prescribed Due to Cost”; https://www.health.com/drug-costs-united-states-cdc-7509659]//kaviWaRu A new report from the Centers for Disease Control and Prevention (CDC) cited the high cost of prescription drugs to cause more than 9 million adults to not take their medications as instructed.1 Prescription drugs can be expensive, especially in the U.S. In fact, research shows that Americans spend more on prescription drugs per capita than people in any other country—or about $1,200 more per person.2 And these high costs are not without consequences. The high cost of prescription drugs has caused more than 9 million adults between the ages of 18 and 64 to skip doses, take smaller amounts, or delay refills, according to a recently released report by the CDC. That number represents 8.2% of adults in 2021 who did not take the prescriptions they needed.1 According to the CDC, women were most likely to skip or delay taking prescribed drugs. Those with disabilities were also impacted by rising drug costs, with 20% taking measures to ration their medications because of cost. And, people in poor health and those without health insurance also did not take their medications as prescribed due to the associated expense.1 “Even when they are covered by their insurance, American patients who struggle to afford the cost of prescription drugs often choose not to take them,” Laura Purdy, MD, MBA, board-certified family medicine physician told Health. “Many people are hesitant to take chronic disease-treating medications, such as those for diabetes, hypertension, or high cholesterol simply because of cost,” she said. “But, this dilemma can lead to a worsening health condition, hospitalization, or even death.” AND it’s on track to worsen. Gordon 5/18 [Sherri; She is an author and journalist covering health and wellness with a Certificate of completion from Ohio State's Patient and Community Peer Review Academy; 5/18/2024; Health; “CDC Report: 9 Million Americans Not Taking Medications as Prescribed Due to Cost”; https://www.health.com/drug-costs-united-states-cdc-7509659]//kaviWaRu A recent RAND Corporation study found that U.S. drug prices were 2.56 times higher than those in 32 comparable countries, with brand-name drug prices averaging 3.44 times higher. What's more, researchers note that across all of the Organization for Economic Co-operation and Development (OECD) nations studied, total drug spending was $795 billion, with the U.S. accounting for more than half of the sales or 58%, but just 24% of the volume.3 “Branded medications are typically the most common for patients to stop taking,” explained Deepti Pidakala, PharmD, a pharmacist with Marley Drug, a full-service pharmacy that offers home delivery nationwide. “They are expensive, require prior authorizations from insurance, and often are not covered at all,” she said. “This waiting period back and forth with insurance, along with the financial strain, causes many patients to stop taking their medications altogether.” A Kaiser Family Foundation Health Tracking Poll found that eight in 10 adults said the cost of prescribed medications in the U.S. was unreasonable.4 Affordability is particularly an issue for those taking four or more prescription medicines. Researchers found that three in 10 of those taking four or more drugs have trouble affording their prescriptions, compared to one in five adults who currently take three or fewer prescription medications. Affordability issues are likely to continue to worsen, especially since prescription drug prices have been on an upward trajectory. Drug spending in the U.S. increased by 76% between 2000 and 2017.3 These costs are expected to rise faster over the next decade than other areas of healthcare spending. 2NC---AT: Key to Innovation High prices and pharma innovation are not zero-sum and do not need to trade off. Conti et al 21 [Rena; has a Ph.D. in health economics & policy at Harvard who focuses on the regulation of the biopharmaceutical market; Richard G. Frank; Senior fellow of economic studies and the director of the Center on Health Policy. He also has a Ph.D.; Jonathan Gruber; a nonresident senior fellow at Brookings and the Ford Professor of Economics and the Chairman of the Economics Department at the Massachusetts Institute of Technology; 11/15/2021; Brookings; “Addressing the trade-off between lower drug prices and incentives for pharmaceutical innovation”; https://www.brookings.edu/articles/addressing-the-trade-off-between-lower-drug-prices-and-incentives-for-pharmaceutical-innovation/]//kaviWaRu The trade-off between prices and innovation need not be this stark and, in fact, is likely avoidable. There are ready policy options that can allow us to meet the goals of both controlling prescription drug costs and promoting investments in innovative new therapies that can make us healthier. The U.S. has successfully pursued policies in the past that improved incentives for innovation and affordability, from basic science investments to programs for financing innovative start-ups. There is significant win-win potential in legislation building on the considerable strengths of drug pricing regulation proposals. R&D does not justify high drug prices. LaFee & Mlynaryk 22 [Scott; He is currently the director of communications and media relations for UC San Diego Health, UC San Diego Health Sciences, and the UC San Diego School of Medicine. He was previously a science writer and editor at the San Diego Union-Tribune, nominated five times for the Pulitzer Prize; Nicole; science writer and research communications and media relations specialist---she was formerly a neuroscientist; UC San Diego Today; “High R&D Isn’t Necessarily Why Drugs Are So Expensive”; https://today.ucsd.edu/story/high-rd-isnt-necessarily-why-drugs-are-so-expensive]//kaviWaRu In the first known study of its type, an international team of researchers evaluated whether high research and development (R&D) costs explain high drug prices in the United States. “There is a presumption that high R&D costs justify high drug prices. If that were true, then we’d see a positive association between the two measures,” said first author Olivier Wouters, PhD, assistant professor at the London School of Economics and Political Sciences. But in a paper published September 26, 2022, in JAMA Network Open, Wouters, in collaboration with colleagues at Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego, found no such association for 60 new drugs approved by the U.S. Food and Drug Administration from 2009 to 2018. The researchers compared data on R&D costs with drug prices. They found no relationship between what pharmaceutical companies spend on R&D and what they charge for new medicines. The authors also assessed whether the therapeutic value of a product was associated with its price, but found no association there either. “Our findings provide evidence that drug companies do not set prices based on how much they spent on R&D or how good a drug is. Instead, they charge what the market will bear,” said senior author Inmaculada Hernandez, PharmD, PhD, associate professor at Skaggs School of Pharmacy and Pharmaceutical Sciences. The pharmaceutical industry spent $83 billion on R&D in 2019, according to the Congressional Budget Office. Companies are estimated to spend somewhere between $1 billion and $3 billion on average to bring a single new product to market. In 2019, the U.S. drug market generated more than $490 billion in revenue, accounting for almost half of the global pharmaceutical market, according to the database company, Statista. Americans spend more on prescription drugs per capita than citizens in any other country. In 2019, that worked out to more than $1,200 per person. A 2021 Rand Corporation study found U.S. drug prices were 2.56 times higher than those in 32 comparable countries. A Kaiser Family Foundation Health Tracking Poll published earlier this year found that eight in 10 adults said the cost of prescribed medications was unreasonable. Studies show that the money did not contribute to innovation. Jung et al 19 [Emily H.; She is a first-year medical student at Emory School of Medicine in Atlanta and a former research assistant at the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital; Alfred Engelberg; He is a retired pharmaceutical intellectual property attorney and philanthropist; Aaron S. Kesselheim; is a professor of medicine at Harvard Medical School and director of PORTAL; STAT News; “Do large pharma companies provide drug development innovation? Our analysis says no”; https://www.statnews.com/2019/12/10/large-pharma-companies-provide-little-new-drug-development-innovation/]//kaviWaRu To test that claim, we examined the provenance of the highest-selling prescription medicines of Pfizer and Johnson & Johnson, the two largest pharmaceutical and biotechnology companies in 2018. We found that these large pharmaceutical companies did not actually invent most of the drugs they sell. Indeed, it appears they have already reduced their investment in the discovery of new medicines to the point where the threat of additional reductions rings hollow and is no longer a persuasive reason for opposing legislation to lower drug prices. 2NC---COVID COVID proves the necessity and effectiveness of U.S. big pharma. Tusk 20 [Bradley; Founder and CEO of Fast Company is a venture capitalist and political strategist; 5/14/2020; Fast Company; “In defense of Big Pharma, the innovation engine we love to hate”; https://www.fastcompany.com/90504726/in-defense-of-big-pharma-the-innovation-engine-we-love-to-hate]//kaviWaRu The cost of producing a vaccine, in other words, is priceless. But expecting Big Pharma to deliver a cure means acknowledging how Big Pharma works. The economic logic that drives up drug prices and fuels constant political outrage also makes rapid drug development possible. They’re two sides of the same coin. Multiple studies show that you can only trim pharmaceutical profits so much before innovation slows, which means fewer new medicines and diminished capacity to solve problems such as SARS-CoV-2 (the virus that causes the COVID-19 disease). The National Bureau of Economic Research has found, for instance, that cutting drug prices in the U.S. by 40 to 50 percent would lead to 30 to 60 percent fewer R&D projects. Another study found that Germany lost 23,000 pharma jobs after it implemented price controls in the 1990s, and Germany slipped from first to third place among the continent’s top drug innovators. As the nonpartisan Information Technology and Innovation Foundation concluded in a white paper last year, “For the issue of pharmaceutical drugs, an overwhelming body of academic research shows that price controls will significantly restrict the number of new drugs in the future.” Every decision involves tradeoffs. Nobody doubts that inequality is baked into this incentive structure—that the same profit motive that makes the U.S. pharmaceutical industry the best in the world also leads to unjust outcomes, especially for the poor. Nor is it a secret that American R&D effectively subsidizes Europe. The question is whether that system can be reformed in a way that doesn’t endanger innovation. Big pharma is key to revolutionize treatments remain the leader in medical innovation---solves disease. Shah 19 [Sandip; founder and president of Market Access Solutions, which develops strategies to optimize patient access to life-changing therapies; 11/21/2019; Naples Daily News; “Opinion: Big Pharma doesn’t deserve all the hate”; https://www.naplesnews.com/story/opinion/contributors/2019/11/21/opinion-big-pharma-doesnt-deserve-all-hate/4267640002/]//kaviWaRu Americans loathe the pharmaceutical industry. It ranks dead last in a recent Gallup poll that tracks the public's opinion of 25 different sectors. Even the federal government is more popular, with a net favorability rating of negative 27 points, compared to pharma's negative 31-point rating. This scorn is misplaced. It's true that the biopharmaceutical sector contains a few bad actors who price gouge and cut regulatory corners. But the majority of drug companies are responsible corporate citizens that spend billions to invent lifesaving medicines. If we let our collective resentment turn into tangible, anti-innovation policies – such as drug price controls – we'll end up worse off. American pharmaceutical researchers deserve credit for the lion's share of medical progress. In 2017, drug firms poured $97 billion into research and development operations in the United States. That's more than double the U.S. government's spending on scientific research. Scientists in U.S. labs are currently developing 4,500 experimental drugs – more than half of all medicines in development worldwide. Thanks to these efforts, Americans are beating deadly diseases in record numbers. Cancer death rates have declined close to 30% since the 1990s. Researchers credit nearly three-quarters of these survival gains to groundbreaking new drugs. Biopharmaceutical research also revolutionized the treatment of HIV/AIDS. Just 30 years ago, a diagnosis was a death sentence. In the mid-1990s, scientists developed highly active antiretroviral therapies. These drugs caused HIV/AIDS death rates to plummet 88%, and have averted close to 1 million premature deaths in the United States alone. Scientists have recently turned their attention to new types of drugs, such as gene and immunotherapies, that reprogram patients' own bodies to fight disease. Doctors are already using these cutting-edge medicines to treat hemophilia, leukemia and blindness. Progress like this doesn't come easy. Each new drug is the result of millions of man-hours of research and testing. It takes over a decade to turn a promising lab compound into a marketable medicine. For every experimental drug that makes it to patients, nine others fail in clinical trials. CP---Ban Patents 2NC---Patents---Cause High Drug Prices Pharma industry abuses the patent system to create monopolies and raise prices. Johnson & Brough 19 [Garrett; co-founder of Lincoln Network; Wayne T.; the president of the Innovation Defense Foundation; 9/13/2019; CNN; “Big Pharma is abusing patents, and it’s hurting Americans”; https://www.cnn.com/2019/09/12/perspectives/drug-patents-abuse/index.html]//kaviWaRu The American patent system has, since our nation’s founding, served as a cornerstone of innovation. But the pharmaceutical industry’s willingness to undermine this system is having real consequences for American patients. The skyrocketing cost of health care has been fueled by rapidly rising prescription drug prices, which are significantly higher for Americans than patients in other wealthy countries. While some argue that this is just the cost of being a global innovator, it is more complicated than that, and a key source of the problem is the abuse of the patent system. Health care costs could be brought down through greater availability of generic drugs and biosimilars - drugs that are identical to branded drugs but distributed by another company after the original patent expires. Unfortunately, these lower-cost alternatives face an uphill battle to gain market access because pharmaceutical companies employ myriad tactics to prevent competition. Large pharmaceutical companies have continually engaged in the strategic accumulation of patents to restrict patient access to more affordable drugs by delaying the entry of generic options into the market. While some of the additional patents represent true incremental innovation, many are deployed strategically to preserve a company’s monopoly rights on the original discovery. All in all, the tactics used are not new or useful, they are simply a way for Big Pharma to maintain their drug monopolies and continue charging American consumers more for drugs than they could if they had competition in the market. Take Namenda, a drug produced by Forest Laboratories used to treat the confusion associated with Alzheimer’s Disease. Forest Laboratories faced generic competition on Namenda starting in 2015. Instead of competing with a generic drug on the market, the company responded by changing its formulation of Namenda from a twice-daily pill to a once-daily version. This new version was patented with protection on the product extending to 2029. The actions of Forest Laboratories were a clear example of the company’s attempt to game the patent system. In fact, they were successfully sued by the State of New York for attempting to block patients from having a choice between the twice-daily and once-daily pills and were forced to settle with New York and abandon their efforts. By gaming the patent system to secure monopolies on their products, pharmaceutical companies are removing the motivation to innovate because they are simply creating new patents that are similar in scope to previously obtained ones, thus creating a captured market. This lack of competition has resulted in price increases averaging 68% since 2012 for the top selling drugs in the United States. CP---AT: Prizes 2AC---Too Expensive Prizes fail---It’s too expensive and results in low investment. Stevens & Ezell 20 [Philip; He was previously an official at WIPO (World Intellectual Property Organization) and holds degrees from th
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