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Omeprazole Fluoxetine Loratadin Metoclopramide Hydrochloride Cipro oxacin Montelukast Fluticasone Quinapril Hydrochloride Flucanazole Eplerenone Lansoprazole Simvastatin Sertraline Pravastatin Glyburide Paroxetine Mitoxantrone Hydrochloride Budesonide Mometasone Furoate Felodipine Estradiol Rocuronium Bromide Rabeprazole Sodium Tiludronate Disodium Losaran Potassium Estradiol Brinzolamide Oxaliplatin Frovatriptan Succinate Ketoconazole Insulin Aspart Esomeprazole Magnesium Brimonidine Tartrate Gemtuzumab Ozogamicin Alprostadil Pimecrolimus Tiagabine Hydrochloride Ziprasidone Mesylate Verapamil Hydrochloride Mometasone Furoate Monohydrate Paricalcitol Ethinyl Estradiol Efavirenz Tramadol Hydrochloride Fluvastatin Sodium
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FIGURE 8.4 U.S. patent expiration dates of selected drugs.
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Sources: Merrill Lynch & Co., Inc., PhRMA, Generic Pharmaceutical Association,
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down 60 percent from 2001 levels because of competition from generics and from AstraZeneca s shift in marketing and advertising to its Prilosec replacement, Nexium. The U.S. patent on Nexium, esomeprazole magne sium, expires in 2014. Patent law is often at odds with medical cost containment. For exam ple the effect of the hotly debated C-91 Bill passed by the Canadian Gov ernment in 1992 was to nearly triple the protection afforded branded pharmaceuticals from competition by cheaper generics. The protection that the branded pharmaceuticals are afforded increased from 7 to 20 years. This concession to the branded pharmaceutical industry was a con dition for Canada s participation in the North American Free Trade Agreement (NAFTA) and General Agreement on Tariffs and Trade (GATT). Prior to the passage of C-91, many patients in the northern United States crossed the border into Canada to purchase lower-priced generics that weren t available in the United States. However, with C-91 in effect, not only is the generic industry in Canada nearly in synch with that of the industry in the United States, but NAFTA effectively prevents the adoption of a national Pharmacare program in Canada because such a program would interfere with the rights of foreign companies to sell drug insurance in Canada. The evolving linkage of intellectual property with trade agreements isn t limited to North America, but is an issue through out Europe as well.
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Designer drugs, at-home tests, and more accessible, more complete online biological databases have the potential to disrupt and rede ne the value chain associated with traditional, one-size- ts-all pharmaceuticals. In par ticular, the future role of the physician as gatekeeper of health-care dollars, especially in the areas of prescription medications and testing, is undergo ing constant erosion. As the effectiveness of direct-to-consumer pharma ceutical advertising demonstrates, consumers are increasingly taking charge of their health care and their health-care dollars. Advances in genomics, proteomics, glycomics, and the related molec ular level technologies are rede ning the patient-doctor relationship and the role of caregivers. For example, consider how the onslaught of ge nomic information will be incorporated into the training and practice of physicians. One possibility is that information on gene testing and related tests will be incorporated into the existing medical specialties as it be comes clinically relevant. This scenario is most likely as new laboratory tests such as gene-chip based diagnostic tools become available. These tests are novel today but are likely to be seamlessly incorporated into the daily activities of most physicians.
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A second scenario is that genomic tests and methods will be concen trated in a single, existing specialty, such as medical genetics or internal medicine. According to the American Board of Medical Genetics, a physi cian certi ed in the eld should have broad knowledge in human and med ical genetics, diagnostic and therapeutic skills in a wide range of genetic disorders, and expertise in risk assessment and genetic counseling. How ever, because much of genomic medicine extends beyond traditional genet ics, internists may be better positioned to apply the stream of advances in molecular medicine to everyday patient problems. A third scenario is that control of genomic information will be concentrated in a new medical spe cialty that would focus on all aspects of genomic medicine. These special ists would be trained on therapeutic cloning, the use of stem cell therapy, genetic engineering, and recombinant DNA techniques. In reality, all three scenarios are likely. Even if specialists in genomic medicine were created, there would be changes in virtually every specialty as new genomic discov eries are made. The rede nition of physician authority, responsibility, and accountabil ity has signi cant economic rami cations. Whoever has the task of evalu ating conventional and new therapies, deciding what constitutes acceptable risk, and assuming long-term accountability, has considerable economic clout and responsibility. For example, in the United States, the premium for malpractice insurance for high-risk specialties such as obstetrics is in excess of $150,000 without the threat of suit for improper genetic ma nipulation. If a genetic therapy inadvertently affects the offspring of a pa tient, the physician may be accountable twenty years later. Without government intervention, insurance may become prohibitively expensive for physicians who deal with gene-altering procedures. Furthermore, ad vances in genetic therapies may accelerate the shift in decision-making au thority from physicians to organizations that de ne best practices and the insurance industry. Looking further into the future, following the current trajectory of ad vances in genomics, computers, data manipulation, and clinical medicine, the role of the traditional physician is likely to be obviated by technology. As technologies such as electronic medical records achieve widespread adoption, it will be commonplace to use computational methods to pro vide automated diagnosis of genomic data collected in the privacy of the patient s home (see Figure 8.5). Once the complex interplay of genes, health, and disease are under stood, best practices databases, populated by rules from third-party payers and clinical experts, can drive automated prescription systems that relegate the physician to optional consults with a patient. Achieving this vision for the future of medicine requires continued progress on multiple technology fronts, as well as the commitment from the clinical and research medical
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