econ turn
ProQuest 14 (Proquest LLC, “Rein In Big Pharma ; Unreasonably High Prescription Drug Prices Are Costing The Country Billions”, Insurance News Net, 7/14/14, http://insurancenewsnet.com/oarticle/2014/07/14/rein-in-big-pharma-unreasonably-high-prescription-drug-prices-are-costing-the--a-529769.html#.U8QCTvldWSo)
In its landmark report last year on the cost of health care, "Bitter Pill," Time magazine argued that the most effective insurance system in the nation is Medicare. That's because rather than negotiate prices down from hospitals' wildly inflated "chargemasters," as private insurers do, Medicare determines the actual cost of procedures and pays providers based on the averages. But even Medicare can't control the runaway pricing of prescription drugs. That's evident in a Sunday News story in May that found Medicare reimbursed 1,493 doctors and other providers in Lancaster County a total of $96.4 millionin 2012 for "Part B" claims -doctor visits, tests and other treatments. At the top of the list of Medicare reimbursements is an ophthalmologist, Dr. Roy D. Brod, who was paid more than $3.3 million in 2012. Why does a retina specialist get more Medicare money than any other doctor in the county? Dr. Brod says it's largely because he treats age-related "wet" macular degeneration, or AMD, by injecting a drug called Lucentis into patients' eyes. Lucentis costs $2,000 per dose. Dr. Brod, like other providers, is reimbursed byMedicare for the cost of the medication, plus 6 percent. That's the hole in the Medicare safety net. As Time pointed out in "Bitter Pill," Medicare is blocked by federal law from negotiating prices for prescription drugs. Instead, Medicare must pay the pharmaceutical companies' "average sales price" plus 6 percent. The average price is set by the company not by Medicare. In other words, drug companies charge what the market will bear. Increasingly, Americans can't bear the cost. Drug costs in the United States are 50 percent higher for comparable medications than they are in other developed countries, according to a research firm, because unlike other nations, the United States does not cap profit margins for Big Pharma. The Time report contends the health care system could have saved $94 billion in 2013 off total prescription drug spending of more than $280 billion if we paid what other countries do for medicine. That's not the only hole in the Medicare safety net. The federal insurance program for older Americans also can't decide whether one drug is more cost-effective than another. So Medicare has to pay for Lucentis, the $2,000-a-dose drug that prevents AMD, even though Avastin, a cancer medication that is proving to be just about as effective as Lucentis for AMD, costs $50 a dose. Dr. Brod, the ophthalmologist, told the Sunday News that he is starting new patients on Avastin and continuing to administer that drug if it does the job. How many other doctors across the country are similarly concerned about treatment costs? And how much are taxpayers shelling out unnecessarily for overpriced prescription drugs? If Congress amended the law to allow Medicare to pay drug manufacturers the same way it reimburses doctors and hospitals, we could save billions in health care costs for older people. For that matter, if Congress had enough backbone to limit profit margins for Big Pharma not to mention for hospitals the whole country's medical bill would be more manageable. If "Bitter Pill" is right, Medicare does a far better job at holding down health care costs than any private insurer. But Medicare could be even more effective if it had authority to hold down prescription drug costs. Diagnosis: The cost of medicine is making all of us sick.
environment/bioD turn Disease research leads to overexploitation of species – turns the environment and biodiversity
NRC 02 (National Research Council, “MARINE BIOTECHNOLOGY IN THE TWENTY-FIRST CENTURY”, Committee on Marine Biotechnology: Biomedical Applications of Marine Natural Products Ocean Studies Board Board on Life Sciences Division on Earth and Life Studies National Research Council, 2002, http://worldtracker.org/media/library/Science/Biotechnology/Marine%20Biotechnology%20in%20the%2021st%20Century%20-%20Nrc.pdf)
Despite a significant human dependence on and concerns for coral reef ecosystems, compelling scientific evidence indicates that current human use and allocation of reef resources are threatening both the ecological and the social sustainability of these ecosystems. Increased harvest pressure is being placed on reef resources to supply subsistence fisheries as well as a growing international demand for reef species for food, traditional medicines, and ornaments. Unfortunately few countries have sufficient knowledge, financial resources, or technical expertise to develop management plans for the sustainable harvest of reef species, and organisms are often extracted unsustainably for short-term economic gains. Although several coral reef species have yielded potential therapeutic agents, concern about adequate supply for preclinical and clinical studies is a critical issue in the development of new biomedical products. Many of the suitable reef species have a limited distribution or occur at a low biomass. Also, individuals often contain only trace amounts of the desired compounds; the low yield requires the harvest of substantial biomass, which may lead to depletion of natural populations (Creswell, 1995). Many species extinctions are predicted in the coming decades in response to increasing pressure from human activities and natural disturbances, and the pharmacological potential of coral reefs may be lost. The continued, largely unregulated, and unsustainable extraction of reef species may have consequences that extend far beyond the overexploitation of these organisms, as their removal may also affect associated species and communities, ecological processes, and even entire ecosystems that are critical to the overall health of the oceans.
Biomedical research leads to overexploitation absent increased regulations – profit motive kills biodiversity
NRC 02 (National Research Council, “MARINE BIOTECHNOLOGY IN THE TWENTY-FIRST CENTURY”, Committee on Marine Biotechnology: Biomedical Applications of Marine Natural Products Ocean Studies Board Board on Life Sciences Division on Earth and Life Studies National Research Council, 2002, http://worldtracker.org/media/library/Science/Biotechnology/Marine%20Biotechnology%20in%20the%2021st%20Century%20-%20Nrc.pdf)
An ecosystem approach to manage the collection of benthic reef species for biomedical research presents numerous challenges, as available information is inadequate on the biology, ecology, and population dynamics of most reef invertebrates. Through the development of partnerships among government agencies, commercial pharmaceutical companies, academia, and local communities, research in identification and screening of bioactive compounds can expand, with concurrent efforts directed toward sustainable management approaches. Benefit sharing with source countries can create economic incentives for reef conservation, provided that mechanisms are in place to direct revenues from bioprospecting toward the development of national and regional conservation programs (Verhoosel, 1998). Possible conservation strategies include the development of a system of marine protected areas and studies to catalogue the diversity and status of the resources contained within these areas. Basic research is also needed on the biology of the target species, linkages among coral reef organisms, and ecosystem processes controlling the distribution and abundance of target species. Finally, a greater emphasis must be placed on coral reef monitoring programs to evaluate harvest impacts and other threats, to provide information needed to establish a sustainable quota, and to adjust management measures in response to new information or subsequent disturbances. Bioprospecting in coral reef environments offers developing countries an opportunity to derive income from the process of natural product research and development and can create economic incentives for biodiversity conservation. An ecosystem management approach will help prevent overexploitation of reef species, thereby offering a continual source of new products. However, additional strategies may be needed to reduce demand when a species is shown to contain valuable bioactive metabolites. In previous instances, up to 1 kilogram of a bioactive metabolite was necessary for clinical evaluation, and a more intensive, longer-term harvest may be required to support commercial production (Duckworth, 2001). Mass pro duction of the target organism through captive-breeding or mariculture may provide a consistent alternative supply without requiring sophistimted equipment for harvest or harvest techniques that are suitable for environmentally sensitive reef environments. Species in demand for the aquarium trade, live reef food-fish markets, and other seafood, and a variety of invertebrates as sources of bioactive compounds, are promising new species for intensive farming. Technology is also being applied to replenish and enhance wild stocks (Bell and Gervis, 1999). There is a growing awareness of the risks associated with mariculture (e.g., introduction of diseases or invasive species, dilution of gene pools and increased biological interactions with other species), but sustainable mariculture can be achieved with responsible application of technology and the use of indigenous species. Selective husbandry and other well-defined mariculture protocols may prcr vide a new tool to improve the yield and quality of bioactive compounds, further reducing the number of individuals needed to provide large quantities of metabolites. Benefit sharing with source countries is a critical step that can provide the financial incentive for field research and monitoring, development of appropriate management strategies that promote sustainable use, and expanded mariculture efforts. Coral reef resources with important biomedical applications have the critical character of being renewable, at least when they are properly managed. Coral reef organisms that are abused can also become extinct, and potential medical benefits from these species will be lost forever.
no impact – disease
No extinction – diseases favor limited lethality and medicine will check
Posner 2004 (Richard Posner, Judge at the US Court of Appeals, Catastrophe: Risk and Response, p. 22-24)//NR
Yet the fact that Homo sapiens has managed to survive every disease to assail it in the 200,000 years or so of its existence is a source of genuine comfort, at least if the focus is on extinction events. There have been enormously destructive plagues, such as the Black Death, smallpox, and now AIDS, but none has come close to destroying the entire human race. There is a biological reason. Natural selection favors germs of limited lethality; they are fitter in an evolutionary sense because their genes are more likely to be spread if the germs do not kill their hosts too quickly. The AIDS virus is an example of a lethal virus, wholly natural, that by lying dormant yet infectious in its host for years maximizes its spread. Yet there is no danger that AIDS will destroy the entire human race. The likelihood of a natural pandemic that would cause the extinction of the human race is probably even less today than in the past (except in prehistoric times, when people lived in small, scattered bands, which would have limited the spread of disease), despite wider human contacts that make it more difficult to localize an infectious disease. The reason is improvements in medical science. But the comfort is a small one. Pandemics can still impose enormous losses and resist prevention and cure: the lesson of the AIDS pandemic. And there is always a lust time.
Burn out stops disease
Lederberg 1999 (Joshua Lederberg, Professor of Genetics at Stanford University School of Medicine, Epidemic The World of Infectious Disease, p. 13)//NR
The toll of the fourteenth-century plague, the "Black Death," was closer to one third. If the bugs' potential to develop adaptations that could kill us off were the whole story, we would not be here. However, with very rare exceptions, our microbial adversaries have a shared interest in our survival. Almost any pathogen comes to a dead end when we die; it first has to communicate itself to another host in order to survive. So historically, the really severe host- pathogen interactions have resulted in a wipeout of both host and pathogen. We humans are still here because, so far, the pathogens that have attacked us have willy-nilly had an interest in our survival. This is a very delicate balance, and it is easily disturbed, often in the wake of large-scale ecological upsets.
No impact to disease
Brooks 2012 (Michael Brooks, Consultant for New Scientist, “Deep future: Why we'll still be here,” New Scientist, Volume 213, Issue 2854, March, p. 36–37, Science Direct)//NR
We are also unlikely to be extinguished by a killer virus pandemic. The worst pandemics occur when a new strain of flu virus spreads across the globe. In this scenario people have no immunity, leaving large populations exposed. Four such events have occurred in the last 100 years – the worst, the 1918 flu pandemic, killed less than 6 per cent of the world's population. More will come, but disease-led extinctions of an entire species only occur when the population is confined to a small area, such as an island. A severe outbreak will kill many millions but there is no compelling reason to think any future virus mutations will trigger our total demise.
No extinction- disease would have to be extremely durable, stealthy, and contagious- that doesn’t happen
Gladwell 1999 (Malcolm Gladwell, The New Republic, July 17 and 24, 1995, excerpted in “Epidemics: Opposing Viewpoints”, p. 31-32)//NR
Every infectious agent that has ever plagued humanity has had to adapt a specific strategy but every strategy carries a corresponding cost and this makes human counterattack possible. Malaria is vicious and deadly but it relies on mosquitoes to spread from one human to the next, which means that draining swamps and putting up mosquito netting can all hut halt endemic malaria. Smallpox is extraordinarily durable remaining infectious in the environment for years, but its very durability its essential rigidity is what makes it one of the easiest microbes to create a vaccine against. AIDS is almost invariably lethal because it attacks the body at its point of great vulnerability, that is, the immune system, but the fact that it targets blood cells is what makes it so relatively uninfectious. Viruses are not superhuman. I could go on, but the point is obvious. Any microbe capable of wiping us all out would have to be everything at once: as contagious as flue, as durable as the cold, as lethal as Ebola, as stealthy as HIV and so doggedly resistant to mutation that it would stay deadly over the course of a long epidemic. But viruses are not, well, superhuman. They cannot do everything at once. It is one of the ironies of the analysis of alarmists such as Preston that they are all too willing to point out the limitations of human beings, but they neglect to point out the limitations of microscopic life forms.
No specie has ever died from disease
Regis 1997 (Ed Regis, author, 1997. “Pathogens of Glory”, New York Times, 5-18, Lexis)//NR
Despite such horrific effects, Dr. Peters is fairly anti-apocalyptic when it comes to the ultimate import of viruses. Challenging the widespread perception that exotic viruses are doomsday agents bent on wiping out the human species, he notes that "we have not documented that viruses have wiped out any species." As for the notion that we're surrounded by "new" diseases that never before existed, he claims that "most new diseases turn out to be old diseases"; one type of hantavirus infection, he suggests, goes back to A.D. 960. And in contrast to the popular belief that viral epidemics result from mankind's destruction of the environment, Dr. Peters shows how the elimination of a viral host's habitat can eradicate a killer virus and prevent future epidemics. This is what happened when the Aswan Dam, completed in 1971, destroyed the floodwater habitat of the Aedes aegypti mosquitoes, carriers of Rift Valley fever virus: "After the Aswan Dam was constructed, there was no more alluvial flooding. . . . Without a floodwater mosquito, the virus can't maintain itself over the long haul. . . . By 1980, Rift Valley fever had essentially disappeared in Egypt." Still, Dr. Peters isn't totally averse to doomsday thinking, and in his final chapter he lays out his own fictional disease scenario, in which a mystery virus from Australia suddenly breaks out in a Bangkok slum. Throw in Malthus, chaos theory and the high mutation rates of RNA viruses, and soon he's got the world teetering on the brink of viral holocaust in the finest Hollywood tradition. But he doesn't know quite what to make of his own scenario. He offers "one valid, simplified equation to describe what we can expect from viruses in the future": mutating viruses plus a changing ecology plus increasing human mobility add up to more and worse infectious diseases. Two pages later, though, he says that "it is impossible to gauge how the actions of man will impact on emerging infectious diseases." If that is true, it discredits the very equation he's given us. In the end, he presents no clear or consistent picture of the overall threat posed by the viruses he discusses. The empirical fact of the matter is that today's most glamorous viruses -- Marburg and Ebola -- have killed minuscule numbers of people compared with the staggering death rates of pathogens that go back to disease antiquity. Marburg virus, discovered in 1967, has been known to kill just 10 people in its 30-year history; Ebola has killed approximately 800 in the 20 years since it appeared in 1976. By contrast, malaria, an ancient illness, still kills a worldwide average of one million people annually -- more than 2,700 per day. More than three times as many people die of malaria every day than have been killed by Ebola virus in all of history. Yet it's Ebola that people find "scary"!
Humans will adapt
Gladwell 1995 (Malcolm Gladwell, The New Republic, July 17. “Excerpted in Epidemics: Opposing Viewpoints”, p. 29)//NR
In Plagues and Peoples, which appeared in 1977. William MeNeill pointed out that…while man’s efforts to “remodel” his environment are sometimes a source of new disease. They are seldom a source of serious epidemic disease. Quite the opposite. As humans and new microorganisms interact, they begin to accommodate each other. Human populations slowly build up resistance to circulating infections. What were once virulent infections, such as syphilis become attenuated. Over time, diseases of adults, such as measles and chicken pox, become limited to children, whose immune systems are still naïve.
Quarantines check extinction
Pharma Investments 2005 (Pharma Investments, analyst group on pharmaceutical industry, 2005. “SARS; Quarantine is cost saving and effective in containing emerging infections” Lexis)//NR
Quarantine is cost saving and effective in containing emerging infections. "Over time, quarantine has become a classic public health intervention and has been used repeatedly when newly emerging infectious diseases have threatened to spread throughout a population. "Here, we weigh the economic costs and benefits associated with implementing widespread quarantine in Toronto during the SARS outbreaks of 2003," scientists writing in the Journal of Infection report. "We compared the costs of two outbreak scenarios: in Scenario A, SARS is able to transmit itself throughout a population without any significant public health interventions. In Scenario B, quarantine is implemented early on in an attempt to contain the virus. "By evaluating these situations, we can investigate whether or not the use of quarantine is justified by being either cost-saving, life saving, or both," wrote A.G. Gupta and colleagues at the University of Michigan in Ann Arbor. "Our results indicate that quarantine is effective in containing newly emerging infectious diseases, and also cost saving when compared to not implementing a widespread containment mechanism," the authors said. Gupta concluded, "This paper illustrates that it is not only in our humanitarian interest for public health and healthcare officials to remain aggressive in their response to newly emerging infections, but also in our collective economic interest. Despite somewhat daunting initial costs, quarantine saves both lives and money." Gupta and colleagues published their study in the Journal of Infection (The economic impact of quarantine: SARS in Toronto as a case study. J Infect, 2005;50(5):386-393).
no solvency - disease Research can’t solve disease – companies lie about the science for profit
Goldacre 14 (Ben, “What the Tamiflu saga tells us about drug trials and big pharma”, The Guardian, 4/9/14, http://www.theguardian.com/business/2014/apr/10/tamiflu-saga-drug-trials-big-pharma)
Today we found out that Tamiflu doesn't work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia. That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are stillroutinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story. And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment. In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn't in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment. Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That's not reliable enough. This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed. First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here the problems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche's proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche's demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply. Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn't have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable. Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials. At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusionsabout its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community. This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as "double blinded" – where neither doctor nor patient should be able to tell whether they're getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients' self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least. Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so. During this period, the global medical academic community began to realise that the brief, published academic papers on trials – which we have relied on for many years – can be incomplete, and even misleading. Much more detail is available in a clinical study report (CSR), the intermediate document that stands between the raw data and a journal article: the precise plan for analysing the data statistically, detailed descriptions of adverse events, and so on.
Can’t solve disease – patent system disincentivizes companies from most important research
Moreno 14 (Carlos, “How Big Pharma is slowing cancer research”, Reuters, 3/31/14, http://blogs.reuters.com/great-debate/2014/03/31/how-big-pharma-is-slowing-cancer-research/)
Even as scientists seek to bring new cancer treatments to market, however, drug patent issues are holding back some researchers. A major hurdle is in combination drug trials that test two or more therapies at once. Pharmaceutical companies often shy away from trials that have great potential, because the drugs may not generate profits if they are used together with a generic drug or a drug patented by a different company. Recently, there have been major advances in our understanding of how cancer progresses. As scientists have sequenced thousands of cancer genomes, patterns are starting to emerge. One clear insight we have gained is the likelihood that no single drug will be able to defeat cancer. The reason most cancers become drug resistant and come back is because their DNA mutates quickly. Cancer cells that are not killed by the drugs survive, continue to grow and replace the cells that have been wiped out. So how can we beat the evolution of cancer cells? Most cancer researchers believe that the way to do it is to use the same approach that holds HIV in check for AIDS patients: with combinations of drugs. These drug cocktails, if used appropriately, may someday control many cancers because the cells resistant to one drug will be sensitive to another. The great challenge is figuring out which drug combinations are likely to work the best. But when it comes time for clinical trials that are necessary to bring drug combinations to market, there are two major hurdles. The first hurdle occurs when two drugs have been patented by two different pharmaceutical companies. When this is the case, quite often neither company wants to fund the trial. This reluctance is because only 8 percent of new drugs obtain FDA approval, clinical trials can take many years to complete, and there can be legal conflicts regarding ownership and publication of results — resulting in the fear of litigation from the other company. There can also be squabbles over how to divide expenses and profits, with one or both parties looking for a bigger cut of the potential financial gains, and both putting profits before patients. The second obstacle can arise when there is no patent protection, and thus no financial incentive to test the cocktail and market it if it works. There is only a financial incentive to move forward if all patents are active and held by a single company, and with drug combinations, this is often not the case.
Can’t solve disease – fundamental scientific barriers to wide applicability
NRC 02 (National Research Council, “MARINE BIOTECHNOLOGY IN THE TWENTY-FIRST CENTURY”, Committee on Marine Biotechnology: Biomedical Applications of Marine Natural Products Ocean Studies Board Board on Life Sciences Division on Earth and Life Studies National Research Council, 2002, http://worldtracker.org/media/library/Science/Biotechnology/Marine%20Biotechnology%20in%20the%2021st%20Century%20-%20Nrc.pdf)
It has been stated that the "search and discovery of exploitable biology" is undergoing a "paradigm shift" as a "consequence of the bioinformatics revolution" (Bull et al., 2000). In the context of natural product-based drug discovery bioinformatics is producing new information that affects many of the key steps in the drug discovery process. Among the most significant developments are the revelation of vast new potential resources available from uncultured microorganisms and the discovery of a plethora of new potential therapeutic targets from various whole-genome sequences. This new knowledge presents tremendous opportunities for the discovery of therapeutic agents from natural sources. There remain, however, significant obstacles impeding the realization of this potential. Unlocking the biosynthetic capabilities of the new realm of marine microbes remains a fundamental scientific challenge. These organisms not only hold the greatest promise for the discovery of new agents from the marine environment but also provide a feasible solution to the inherent problem of supply Studies of their physiology and means for their cultivation are vital. A major obstacle to the discovery of new marine natural products with promising biological activities is simply the difficulty of having them evaluated in a wide range of targeted assays. Although new therapeutic targets are being developed at an astonishing rate, ability to evaluate marine chemodiversity in these assays is severely limited. Part of the limitation owes to the scarcity of the compounds, which are often isolated in minute quantities insufficient to supply a library for repeated rounds of bioassay Lacking a renewable source or reasonable synthetic route, many of these compounds will never have more than a few targets. The traditional process of naturalproduct discovery may preclude their evaluation against the widest range of biological targets, especially in ultrahigh-throughput-screening systems. Through its component operations of Ayerst and the former Medical Research Division of American Cyanamid or Lederle Labs, V/yeth-Ayerst Research, the pharmaceutical research and development arm of American Home Products, has a rich history in the discovery and development of therapeutic agents from natural sources. At Lederle, the tetracycline family of antibiotics was the first product line derived from nature. Aureomycin (chlortetracycline) was isolated in the early 1940s from the soil organism Streptomyces aureWciens and was followed shortly thereafter by four improved versions; the final one, Minocin, was introduced in 1971 _ Research has continued on this important class of antibiotics at V/yeth and a number of agents are advancing toward the marketplace. Two more recent microbial-derived commercial products are Rapamune (rapamycin) for use in transplantation and Mylotarg, a calicheamicin immunoconjugate targeting acute myeloid leukemia.
no solvency - science Can’t solve new drugs or innovation – collection and maintenance of molecules is scientifically impossible
Martins et al. 14 (Ana Martins, Helena Vieira, Helena Gaspar, and Susana Santos, “Marketed Marine Natural Products in the Pharmaceutical and Cosmeceutical Industries: Tips for Success”, Marine Drugs 12, http://www.ncbi.nlm.nih.gov/pubmed/24549205)
Several different problems are associated with supply and technical issues. The first one is related to the variability of the organism itself For instance, taking the example of sponges, the high frequency of their bioactive metabolites is interpreted as chemical defense against environmental stress factors such as predation, overgrowth by fouling organisms or competition for space. The highest incidence of toxic or deterrent sponge metabolites is found in habitats such as coral reefs that are characterized by intense competition and feeding pressure. Because these environmental conditions are not static, it is likely that a resupply of the same organism does not provide the same metabolite. Also, in the case of marine invertebrates another challenge is the fact the microorganisms are sometimes the actual producers of the bioactives. Once a particular natural product has been isolated and identified as a lead compound, the issue of its sustainable supply is faced. Most of the times, the compound of interest is present only in low amounts and/or can be very difficult to isolate [17]. In the case of tissues of marine invertebrates, which present unique extraction-related problems due to their high water and salt content, this problem can be even more challenging. Whatever the use of the compound (drug, cosmetic, etc.), several grams to hundreds of grams are required for preclinical development, multikilogram quantities are needed for clinical phases and tons for cosmetic uses. Mariculture (favoring by farlning the growth of the organism in its natural milieu) and aquaculture (culture of the organism under artificial conditions) have been attempted in order to solve the problem of sustainable supply of macroorganisms. However, the unique and sometimes exclusive, conditions of the sea make cultivation or maintenance of the isolated samples very difficult and often impossible. For example, sponges and their microbiota are generally not suitable for cultivation, hence, the compound of interest may need to be extracted and purified from the specimens collected in the wild [47]. These constraints lead to the loss of a major portion of the available marine biodiversity and represent a major bottleneck in the sustainable supply of the desired natural compound. This lack of sustainable supply of substances has stopped further development of several highly promising marine compounds, and attempts have been made to overcome this barrier by developing synthetic or hemisynthesic analogues, derivatives with more manageable properties, or by design of a pharmacophore of reduced complexity which can then be synthesized [30]. However, it is worth noting, that these approaches embrace themselves their own challenges. Total synthesis is by no means an easy undertaking task, and chemistry still has a very long way to go before it can make any molecule in a practical manner. NP are complex and exquisite molecules possessing, almost always, one or several stereocenters, a fact that renders their synthesis hard to achieve, since enanteo or diastereoselective synthetic or purification processes are difficult to perform. Hemisynthesis may be, in some cases, a good solution for compound's supply. This process involves harvesting a biosynthetic intermediate from the natural source, rather than the lead itself; and converting it into the lead. This approach has two advantages. First, the intermediate may be more easily extracted in a higher yield than the final product itself. Second, it may allow the syntheses of analogues of the final product.
alt cause Alt cause – lack of intellectual property protection makes marine drug development impossible
NRC 02 (National Research Council, “MARINE BIOTECHNOLOGY IN THE TWENTY-FIRST CENTURY”, Committee on Marine Biotechnology: Biomedical Applications of Marine Natural Products Ocean Studies Board Board on Life Sciences Division on Earth and Life Studies National Research Council, 2002, http://worldtracker.org/media/library/Science/Biotechnology/Marine%20Biotechnology%20in%20the%2021st%20Century%20-%20Nrc.pdf)
The commercial development of successful pharmaceutical products and medical devices is costly, time consuming, and complex. For example, commercialization of an innovative therapeutic agent from a new chemical entity (NCE) typically requires the investment of hundreds of millions of dollars. Successful commercialization further requires the sustained, coordinated efforts of thousands of people working together, worldwide, for periods of 10 years or more toward achievement of a single goal: market entry. For biomedical technologies, commercial development encompasses a dauntingly broad array of functions, including nonclinical testing (both pharmacological and toxicological), regulatory and legal affairs, clinical research, product formulation, manufacturing, packaging, labeling, marketing, sales, education, and post-market surveillance (Cato, 1988; Trenter, 1999). Creating a commercially successful pharmaceutical product or medical device is also risky. The transition from initial laboratory-based proof-of concept development to early-stage commercial development is so exceedingly difficult that it is known colloquially among technology developers as "The Gap" or "The Valley of Death." In pharmaceutical development, "The Gap" is perhaps more appropriately called "The Abyss," since the vast majority of promising research-stage therapeutic agents fail to enter clinical testing. Of those investigational new drugs that enter clinical testing, only a small proportion reach the marketplace. If a pioneering new product does manage to succeed commercially, competing generic products are guaranteed to enter the marketplace and erode profit margins and market share as soon as the pioneering product loses exclusivity For those reasons, corporations and their shareholders will invest the requisite capital and commit the necessary personnel to development of a biomedical product only when effective intellectual-property protection guarantees exclusivity for that product after market entry It is not surprising then, that intellectual-property rights form one of the cornerstones on which the modern biomedical industry is based. Intellectual-property protection is essential to the successful commercialization of marine biomedical technologies.
alt cause – rainforests
Tropical rainforests solve the aff- they have massive amounts of bio-d and potential to cure a litany of diseases
Halter 2010 (Reese Halter, writer for the Huffington Post, September 2, 2010. “Stupendous tropical rainforests offer medicine and fight global warming”. http://www.huffingtonpost.com/dr-reese-halter/stupendous-tropical-rainf_b_700909.html)//NR
The breathtaking luxuriant tropical rainforests occupy about 13 percent of Earth's surface. These incredibly complex and diverse ecosystems account for half of the known biological diversity (about 800,000 different species), and conservatively there are at least another 9.2 million species yet to be discovered. The world's tropical forests can be divided into four major regions. The American tropical forest region includes part of South America, Central America, the Galapagos Islands and the Caribbean. The African tropical forest region encompasses the Zaire Basin, the coastlands of West Africa, the uplands of East Africa and Madagascar. The Indo-Malaysian tropical forest region occupies parts of India, Burma, the Malay Peninsula and many of the Southeastern Asian islands. The Australasian tropical forest region spreads over Northeast Australia, New Guinea and the adjacent Pacific Islands. Some consider the Hawaiian Islands a smaller fifth region. There are five types of tropical climates: rainy tropics, monsoonal tropics, wet-and-dry tropics, tropical semi-arid and tropical arid climate. Irrespective of the hemisphere they all occur within 23 degrees of the equator. Most of these forests have rainfall that at least exceeds 79 inches. Rainforests significantly influence rainfall. About 75 percent of rainfall evaporates directly or via the trees, and provides most of the moisture for cloud formation and rain further inland. Deforestation near the coast breaks this cycle and denies rainfall to inland tropical forests. The complexity of millions of organisms interacting in tropical rainforests can perhaps only be matched by that of underwater life in some coral reefs. Tropical rainforests contain big, tall trees some in excess of 230 feet with flaring buttresses and a bizarre array of aerial roots. Canopies are rich with life: woody climbers resemble elaborate scaffolds; stranglers surround the trunks of trees; liverworts (leafy-looking moss-like plants) over-grow leaf blades; orchids grow in the crown humus; ants feed from flowers; bees and other insects including ants pollinate flowers; birds and bats disseminate seeds, rodents feed on fruits and leopards prey on small mammals. Most tropical soils are extremely low in nutrients. How are they able to support such rich plant life? Ants, in large part, greatly assist in helping to break down leaves, twigs, fallen trunks and dead animals thereby recycling nutrients which are immediately taken-up by tree roots. When tropical forests are removed the soils cannot support luxuriant growth. The natural occurrence of fire in tropical rainforests can occur from lightning and along the edges of lava flows and from hot ash from active volcanoes. The natural frequency of fires in tropical rainforests is rare. Usually rainforests are saturated and fire does not spread far. However, the fierce El Nino of 1998 brought extreme drought conditions to Southeast Asian forests which enabled massive fire to decimate 24,957,646 acres of forestland. Why are tropical rainforests so rich with so many different plant and animal species? These forests contain an awesome potential for new forms of life to develop or a process known as speciation. New species arise from isolated populations. These new species result from either a successful mutation or recombination of existing genes that have adapted to a change in the physical environment. Is there a higher rate of successful mutations in the tropics? Yes. Why? The levels of ultra-violet-B radiation (from the sun) are naturally the highest at the equator and within the range of the tropical forest regions compared to all other forest types on Earth. And ultra-violet radiation (which promotes cataracts and skin caner in humans) also promotes plant mutations and hence the rate of tropical speciation is greater than anywhere else on the globe. Speciation increases diversity and steps-up natural selection which results in the progress of evolution. Tropical forests also contain a cornucopia of potent medicines to combat cardiovascular and neurological diseases and cancers. In addition, drugs like quinine from the South American cinchona tree fight malaria; vincristine and vinblastine from the Madagascar rose periwinkle offer hope to those afflicted with pediatric leukemia and Hodgkin's disease; active ingredients in Central and South American dart-poison frogs fight cardiac arrhythmias, Alzheimer's disease, myasthenia gravis and amyotrophic lateral sclerosis. Tropical forests are being felled at an astounding rate -- a thousand times greater than those which occur naturally -- approximately 55,000 square miles a year. This is equivalent to the area of Switzerland and the Netherlands combined or to the size of a football field that is lost senselessly every second of each day of the year. Each year we are loosing at least 27,000 unknown species with unknown medicinal potentials. Currently, 25 percent of all medicines are derived from tropical plants and animals. As climate change unfolds, scientists have predicted more, and more intense, wild weather around the globe. Recently, a half a billion trees were blown over in one horrendous Amazon storm. The incidences of diseases will skyrocket. The loss of biological diversity from tropical rainforests will impede researchers from finding cures to those diseases. Tropical rainforest ecosystems must be protected, if not for us then certainly for our children.
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