Small Pharma CP - Michigan 7 2024 JRY

Small Pharma CP
Notes
This counterplan is designed to be run with the Business confidence DA put out by CPSW. Using the Trademarks crush small businesses links. (Trademark General.)
Counter-plan does two things
Funds NIH for research and clinical trials
Bans Patent Thickets and Evergreening practices.
*The Biden Admin already gave Medicare the right to negotiate prices.
Blumenthal makes all these claims.
2NC Solvency Cards exist for each plank and obviously kick as you need, be careful tho because Blumenthal thinks all three are necessary for solvency. Kick plank if they read a specific biz con link to one of the planks, I think the small biz story is the internal link but they can make an economics argument.
Blumenthal argues this reduces focus and power of Big Pharma and promotes small pharma. It has an internal net benefit that says big business abuses lead to millions of deaths because of lack of care.
In theory this could be used against any Trademark or Patents affs that promotes big pharma.
We’d like to thank Adam, Albert, Arnav, Casey, Clara, Elroy, Emma, Hemanya, Iris, Ivah, Lola, Maria, Matthew, Molly, Raj, Riley, and Sara for cutting the evidence in this file.
1NC’s
1NC CP
The United States federal government should increase National Institute of Health funding for research and clinical trials.
The United States federal government should end patent thickets and evergreening of biopharmaceutical patents.
Counter-plan solve innovation while supporting and protecting small pharma.
Blumenthal ’21 (David Blumenthal – professor of health policy at Harvard University, “The U.S. Can Lower Drug Prices Without Sacrificing Innovation”, Harvard Business Review, Available online: https://hbr.org/2021/10/the-u-s-can-lower-drug-prices-without-sacrificing-innovation, 10-1-2021, Accessed 7-29-2024)//ILake
Legislation giving Medicare the ability to negotiate drug prices in the United States would make their life-saving potential immediately available to millions of Americans who cannot now afford them, thus extending lives and alleviating suffering. The pharmaceutical industry, however, has done a masterful job of arguing that these Americans must suffer in the short term since lower prices would gut long-term innovation in drug development.
This is a false choice. We need not trade the certainty of saved lives now for the possibility of saved lives in the future.
The reason: Large pharmaceutical companies are nowhere near as important to real drug innovation as they purport to be. Furthermore, smart policy changes can sustain and increase the pace of life-changing breakthroughs in biomedicine through increased funding of the National Institutes of Health (NIH), cutting the costs and accelerating the speed of clinical trials, and reforming patent law to stop innovation-blocking abuses used by Big Pharma to prevent new drugs from entering the market.
The Congressional Budget Office estimated that reducing the pharmaceutical industry’s revenues would result in two fewer drugs in the next decade, 23 fewer in the following decade, and 34 fewer drugs in the third decade. Predictions 20 to 30 years out are necessarily imprecise, but in any case, many of those projected new therapies would likely be neither novel nor more valuable than existing drugs. That is, they wouldn’t be innovative.
Many would be modified versions of existing drugs, created merely to extend patent protections and thus monopolies over existing therapeutics. When Medicare Part D dramatically increased the pharmaceutical industry’s revenues 18 years ago, major drug companies directed their drug-development efforts primarily at drug classes where there were already five or more products on the market. Currently, the majority of new patents filed by large pharmaceutical companies are modifications of drugs already on the market.
Historically, many breakthrough products did originate with large pharmaceutical companies, but the innovation process in biomedicine has changed fundamentally. Truly innovative therapies — like the mRNA vaccines for Covid-19 that are saving untold number of American lives — now originate in small companies that are spinoffs of university research efforts mostly funded by the NIH and philanthropies. In 2018, such small firms accounted for nearly two-thirds of the brand new drugs patented in the United States and nearly three-quarters of drugs in the late stage of the development pipeline. The mRNA technology underlying the Moderna and Pfizer-BioNTech vaccines came out of NIH labs, the University of Pennsylvania, and MIT.
To be sure, large pharmaceutical companies play a critical role in the end stage of drug development, funding and running essential clinical trials and navigating regulatory approvals. But they are no longer the dominant source of true innovation, and maintaining their enormous profits at current levels — which, at 15% to 20% of revenues, well exceed market standards — is no longer an efficient way to promote biomedical innovation. And it is worth remembering that Big Pharma spends its revenues on many less productive activities than clinical trials and regulatory approvals, including lobbying and political contributions (more than $800 million in the 2016 to 2020 period) and marketing (tens of billions of dollars annually).
The United States needs a new strategy for drug innovation that recognizes the new reality of the biomedical innovation process, and the true, limited role of Big Pharma. We could start by reinvesting a substantial fraction of the hundreds of billions of dollars that could be saved from pending drug-payment-reform legislation into the most powerful engine of innovation in drug development: the NIH and its academic research partners. This would likely generate a flood of truly innovative, life-saving products — not a flock of me-too drugs — that small companies could perfect and Big Pharma could steer to market.
Policymakers and regulators should also develop innovative ways to reduce the cost and increase the speed of clinical trials needed to demonstrate the safety and efficacy of new agents. Operation Warp Speed showed how this is possible through government-industry partnerships. The federal government not only funded the research needed to make the mRNA vaccines but also assumed some of the financial risk associated with the vaccines’ clinical trials. Our pandemic experience should precipitate new policymaking to make clinical trials cheaper and faster.
Also critical will be reforms of patent law to reduce the frivolous use of patents by Big Pharma to inhibit innovation. Current patent law enables large pharmaceutical companies to spend billions of dollars annually on legal maneuvering to protect existing patents and preserve their market monopolies.
One strategy they use is creating so-called “patent thickets” around existing products. These consist of large numbers of often meaningless patents — for such things as moving to a time-release formulation — that competitors have to challenge in court before they can market competing products. For example, AbbVie, which markets the world’s best-selling drug, Humira, has filed 257 related patent applications. Such challenges can take years to adjudicate and cost huge sums in legal fees. Meanwhile, Big Pharma maintains its monopolies and pricing power for decades longer than the 17 years contemplated under current law.
The United States needs an effective strategy for maximizing drug innovation and the huge benefits to humanity that it promises. Protecting the revenues of Big Pharma is not that strategy.
Allowing Big Pharma to control research and development causes 500,000 deaths and year and prevents innovation in biopharmaceuticals.
ABRAMSON 22 [John David Abramson is an American physician, teaches primary healthcare at Harvard “Big Pharma Is Hijacking the Information Doctors Need Most” 4/28/22 https://time.com/6171999/big-pharma-clinical-data-doctors/ CG]
Back in 1982, when I first began my career as a family practitioner in a small town of Boston, I was confident that the care I’d provide would be as effective as the care patients receive anywhere in the world. At the time, the death rate for Americans was lower than that of comparable countries, resulting in 128,000 fewer deaths annually. Although healthcare was expensive—costing 2.3% more of our GDP than the average of 11 other wealthy countries—the rapid growth of HMOs and managed care plans promised to make our healthcare even more effective and efficient. Over the ensuing four decades, however, the opposite has occurred. The same age-adjusted mortality rate has improved so much more in comparable countries that, by 2017, an excess 478,000 Americans were dying each year. This translates into an extra 1,300 deaths daily, equivalent to three jumbo jets crashing every day. The everyday poor health of Americans and the inability of our healthcare system to mitigate preventable deaths amounts to a crisis that dwarfs even the COVID-19 pandemic. And our excess spending has risen to 6.8 percent of GDP, or $1.5 trillion per year. This raises a key question: Why have so many smart, well-trained doctors stood by as American healthcare descended into a state of profound dysfunction? The answer lies in the gradual, nearly invisible commercial takeover of the medical “knowledge” that doctors are trained to trust. This transition started in the 1970s, when the acceptance rate of grant applications for funding from the National Institutes of Health shrank—from roughly half of medical research applications to one-third. Then, in 1981, President Ronald Reagan slashed government support of university-based medical research, further pushing academic researchers into the waiting arms of industry, especially ph 2armaceutical companies. Following the 1980 passage of the University and Small Business Patent Procedures Act, nonprofit institutions and their researchers were allowed to benefit financially from the discoveries made while conducting federally funded research. Former president of Harvard University Derek Bok expressed concern about the growth of commercial activities within academia: “Making money in the world of commerce often comes with a Faustian bargain in which universities have to compromise their basic values—and thereby risk their very souls…” The biggest shift was, however, still to come. Over the past few decades, the drug companies have taken over most of our clinical research. In 1991, academic medical centers (AMCs)—hospitals that train doctors and conduct medical research—received 80 percent of the money that industry was spending to fund clinical trials. The drug companies relied on academic researchers for their expertise in designing studies, enrolling patients, and analyzing the data. This arrangement allowed academics to receive the funding they needed while still preserving much of their independence. But by 2004, the percentage of commercially funded clinical trials conducted by AMCs had fallen from 80 to just 26 percent. A look at the research contracts between corporations (mostly Big Pharma companies) and academic medical centers shows that 80% allowed the commercial funder to own, and thus control, the data from jointly conducted research. Furthermore, fully half of the research contracts between drug companies and academic institutions—the partnerships with the highest likelihood of upholding rigorous research standards—allowed industry insiders to ghostwrite clinical trial reports for publication in scientific journals, relegating the named authors to the position of “suggesting” revisions. Nonetheless thorough peer review ensures that these reports are accurate, right? Wrong. Unbeknownst to almost all doctors, peer reviewers are not granted access to the underlying data that serves as the basis for the reported findings. The drug companies own that data and keep it confidential as “corporate property.” Reviewers must rely on brief data summaries included in the submitted manuscripts. Peer reviewers at even the most prestigious medical journals cannot possibly attest to the accuracy and completeness of the articles they review. This sham was exposed in 2005 when the editors of an article published in the New England Journal of Medicine admitted they had not seen relevant data from a clinical trial involving Merck’s arthritis drug Vioxx. Five years earlier, the article had extolled the drug’s safety even though neither the editors nor the peer reviewers had been granted access to underlying data, which showed three heart attacks that had occurred in patients treated with Vioxx were not reported. Had this data had been properly disclosed and analyzed when the manuscript was first submitted, the article would have shown that Vioxx significantly increased the risk of heart attack five-fold when compared to over-the-counter naproxen (Aleve). And many of the estimated 30,000 Americans who died as a result of taking Vioxx after the incomplete article was published would not have been exposed to the drug. To this day, Big Pharma companies remain unwilling to disclose their underlying clinical trial data. The most recent example involved Pfizer’s COVID-19 vaccine. In September 2021, one month after the vaccine had been granted full approval by the U.S. Food and Drug Administration (FDA), a group of medical researchers and scientists sued the agency for the release of 451,000 pages of scientific documents it had evaluated prior to granting the vaccine full approval. Even though the agency required only 108 days to sufficiently evaluate these documents before granting the vaccine formal approval, the FDA (with Pfizer wanting to join the lawsuit), argued that the fastest they could release the data was five hundred pages per month, meaning that it would take seventy-five years before the documents were released in full. On January 6, 2022, U.S. District Judge Mark Pittman ruled that the FDA must release 55,000 (not 500) pages of the documents each month until complete. I want to be clear that I’m a strong advocate of getting vaccinated and boosted (especially for people age 65 and older), the CDC’s analysis of real-world data shows that last December unvaccinated adults had 41 times the risk of dying of COVID-19 compared to fully vaccinated and boosted adults. But I believe just as strongly that doctors and the public must have access to the underlying clinical trial data that the FDA approval is based upon now—not in seventy-five years. The lack of transparency of clinical trial data in peer review is similar around the world. But the effect is far greater in the U.S. because of our unique pharmaceutical policy. We have no formal assessment that compares the medical benefit and economic value of new drugs to older therapies, so health-care professionals do not have access to this critically important information. Federally funded clinical practice guidelines are not allowed to include the relative cost of therapies in their recommendations, which means there is no consideration given to the chance that a drug may unnecessarily bankrupt patients or inflate the cost of health insurance. Further, the price of brand-name drugs is unregulated in this country, which is why they cost 3.5 times more in the U.S. than in other OECD countries. And unregulated prices increase the reward-to-risk ratio for overly aggressive marketing practices in the U.S. The industry’s control over what doctors believe about optimal therapeutics explains why new, expensive drugs are used more liberally in the U.S. than other countries. Without access to the actual clinical trial data, medical journals are publishing unvetted articles that doctors then rely on to treat their patients. Although prescription drugs “only” account for 17% of U.S. health-care expenditures, this has become a “tail wags dog” situation: The drug companies control the “knowledge” that informs doctors’ clinical decisions. This leads to soaring pharmaceutical profits and crippling healthcare costs, while doctors have no way of knowing which therapies are more effective—or more efficient. Americans deserve better.
2NC --- CP
2NC --- NIH Funding Solves
Increasing NIH funding key to innovation and competition
Atkinson 19 (president of the Information Technology and Innovation Foundation, Ph.D. in City and Regional Planning from the University of North Carolina at Chapel Hill, “Healthy Funding: The Critical Role of Investing in NIH to Boost Health and Lower Costs”, March 25 2019, ITIF https://itif.org/publications/2019/03/25/healthy-funding-critical-role-investing-nih-boost-health-and-lower-costs/ ) CKG
The federal government, principally through the National Institutes of Health (NIH), funds scientific research related to biology and human health that sets the stage for applied research and development (R&D) activity by industry, ultimately leading to the commercialization of new medicines and treatments. New drugs not only improve the quality and length of lives but reduce the costs to society from illness. In order to accelerate biomedical innovation, Congress doubled NIH founding around the turn of the millennium. The results are paying off with basic and translational research, including discoveries of the genetic basis of disease and development of related diagnostics and therapies. For example, cancer therapies are being tailored not just to a patient’s genome but to the genome of that patient’s tumors. Other discoveries include sickle cell genomic therapy,1 immunotherapy for breast cancer,2 a universal flu vaccine, the TAILORx genetic screening breast cancer trial,3 and discoveries for the treatment of Alzheimer’s.4 NIH funding overall plays an important role, not only in biomedical innovation, but in enabling a competitive U.S. life sciences industry, and the millions of good paying jobs associated with it. In fact, while overall manufacturing jobs have declined in the last two decades, the number of biopharmaceutical industry jobs has grown. As such, increasing NIH funding is important not only to improving the health of Americans, but in reducing health care costs and spurring global life sciences competitiveness.
Boosting NIH funding has long been a nonpartisan issue. For example, at a 2015 forum, former Republican House Speaker Newt Gingrich and Senator Elizabeth Warren (D-MA) both called for significant increases in NIH funding.5 And there is currently strong bipartisan support in Congress, with senators Roy Blunt (R-MO) and Patty Murray (D-WA) and representatives Rosa DeLauro (D-CT) and Tom Cole (R-OK) leading the charge for increases in NIH funding. Moreover, Americans are extremely optimistic and interested in biomedical breakthroughs. A recent survey conducted on behalf of the USA Today Network and the Charles C. Koch Institute asked Americans to name three areas of technological change they were most excited about for the future. Medical innovation, including pharmaceutical breakthroughs, ranked number 1, by an equal proportion (61 percent) of Democrats and Republicans, and an even higher share (66 percent) of rural Americans.6
However, even with recent increases, NIH funding as a share of GDP in 2019 is still 12 percent below that of 2003. Getting NIH funding to that 2003 level will require Congress to appropriate an additional $7.4 billion in FY 2020.7 As such, Congress should increase the NIH budget by around $8 billion annually over the next two years, and then maintain regular steady increases—ideally 2 to 3 percentage points faster than the nominal rate of GDP growth.
This report briefly discusses the structure and role of NIH. It then examines NIH funding history over the last two decades, and reviews the scholarly evidence on the role of drug innovation in improving human health and its effect on the U.S. economy. The report then reviews studies examining the role of NIH on biomedical innovation and how it supports U.S. bi

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