A significant number of Americans die each year from a resistant form of staphylococcus aureus. See Tanner, L., “Staph Fatalities May Exceed AIDS Deaths,” available at <http://www.newsvine.com/_news/2007/10/16/1029203-staph-fatalities-may-exceed-aids-deaths> (last visited April 27, 2009). Moreover, the WHO estimates that 1.6 million deaths resulted from tuberculosis in 2005. Both the highest number of deaths and the highest mortality per capita are in the Africa region. A particularly dangerous form of tuberculosis is multidrug-resistant tuberculosis. See WHO Fact sheet No. 104, Tuberculosis, Revised March 2007, available at <http://www.who.int/mediacentre/factsheets/fs104/en/> (last visited April 16, 2009).+(last+visited+April+27,+2009).+Moreover,+the+WHO+estimates+that+1.6+million+deaths+resulted+from+tuberculosis+in+2005.+Both+the+highest+number+of+deaths+and+the+highest+mortality+per+capita+are+in+the+Africa+region.+A+particularly+dangerous+form+of+tuberculosis+is+multidrug-resistant+tuberculosis.+See+WHO+Fact+sheet+No.+104,+Tuberculosis,+Revised+March+2007,+available+at++(last+visited+April+16,+2009).>Google Scholar

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For a discussion of these pull-mechanisms, see the following, for example: Love, J., “Would Cash Prizes Promote Cheap Drugs?” New Scientist Magazine, November 12, 2007, at 24–25; Infectious Diseases Society of America (IDSA), Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates a Public Health Crisis Brews, 2004; Spellberg, B., “Antibiotic Resistance and Antibiotic Development,” The Lancet Infectious Diseases 8, no. 4 (2008): 211–212; Spellberg, B., Guidos, R., Gilbert, D., Bradley, J., Boucher, H. W., Scheld, W. M., Bartlett, J. G. and Edwards, J., “The Epidemic of Antibiotic-Resistant Infections: A Call to Action for the Medical Community from the Infectious Diseases Society of America,” Clinical Infectious Diseases-Chicago 46, no. 2 (2008): 155; Nathan, C., “Antibiotics at the Crossroads,” Nature 431, no. 7011 (2004): 899-902; Nathan, C. and Goldberg, F. M., “Outlook: The Profit Problem in Antibiotic R&D,” Nature Reviews Drug Discovery 4, no. 11 (2005): 887-891; Pogge, T., “Human Rights and Global Health: A Research Program,” Metaphilosophy 36, nos. 1-2 (2005): 182-209; Power, E., “Impact of Antibiotic Restrictions: The Pharmaceutical Perspective,” Clinical Microbiology and Infection 12, no. s5 (2006): 25-34; Love, J. and Hubbard, T., “The Big Idea: Prizes to Stimulate R&D for New Medicines,” Chicago Kent-Law Review 82, no. 3 (2007): 1519-1554; Kremer, M. and Glennerster, R., Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases (Princeton: Princeton University Press, 2004); Stiglitz, J. E., “Scrooge and Intellectual Property Rights,” BMJ 333, no. 7582 (2006): 1279; Outterson, et al., supra note 2; Outterson, K., “Antibiotic Resistance and Antibiotic Development – Author's Reply,” The Lancet Infectious Diseases 8, no. 4 (2008): 212-214.Google Scholar

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The Infectious Diseases Research and Development Act (HR 3154), introduced to the U.S. Congress in July of 2005 by Congresswoman Barbara Cubin, recommends implementation of wildcard patent extensions for up to two years. The Project Bioshield II Act (S 975), introduced to the U.S. Congress in April of 2005 by Senators Lieberman, Hatch and Brownback, also recommends implementation of wildcard patent extensions for up to two years. Models involving five-year wild-card patent extensions have also been discussed (see Moran, M., Fast Track Options as a Fundraising Mechanism to Support R&D into Neglected Diseases: Pharmaceutical R&D Policy Project, London School of Economics, 2005).Google Scholar

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The assumption that annual sales of a patented drug stay constant throughout the duration of the patent is controversial. 2002 world-wide sales of Lipitor were up 20% from the year before. 2002 world-wide sales of Zocor (Merck) were up 13% from the year before. 2002 world-wide sales of Losec/Prilosec (AstraZeneca) were down 19% compared to the previous year. For more sales data on leading products in 2002 global pharmaceutical sales, see table from IMS World Review 2003, available at <http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_3665_41336931,00.html> (last visited July 17, 2008).+(last+visited+July+17,+2008).>Google Scholar

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See Outterson, , Samora, , Keller-Cuda, , supra note 2, at 561; Outterson, , supra note 3, at 212.Google Scholar

This 2001 estimate of the cost of a new drug is put forward by The Tufts Center for the Study of Drug Development. See: <http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=6> (last visited April 16, 2009). It should here be noted that another estimate puts the price of new drug at 1.7 billion. See Gilbert, J., Henske, P. and Singh, A., “Rebuilding Big Pharma's Business Model,” In Vivo: The Business & Medicine Report 21, no. 10 (2003): 73–80. This number is cited by the U.S. Department of Health and Human Services(see FDA, Challenge and Opportunity on the Critical Path to New Medical Products, U.S. Department of Health and Human Services Food and Drug Administration, 2005, at 3.) If the price for a new drug is this high, then some of the sting is taken out of the cost-effectiveness objection.Google Scholar

See Outterson, , Samora, and Keller-Cuda, , supra note 2, at 561.Google Scholar

This number is arrived at by dividing Outterson and colleagues' $8.7 billion estimate by four.Google Scholar

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In private correspondence, Eddie Power (Global Medical Director, Clinical Research, Cubist Pharmaceuticals) suggested that the profit benchmark that big pharma sets for continued R&D on a product is around $500 million.Google Scholar

This number is arrived at by adding Outterson and colleagues' estimate of the cost of a new antibiotic to Spellberg's cost-estimate and dividing this number by two and then detracting 3/4 from it.Google Scholar

See Outterson, , supra note 3, at 213.Google Scholar

See Spellberg, et al., supra note 22.Google Scholar

The annual societal cost of $2.7 billion is an estimate of Spellberg, et al., supra note 22, at 170.Google Scholar

See Spellberg, et al., supra note 22.Google Scholar

See Outterson, and Samora, , Keller-Cuda, , supra note 22, at 562.Google Scholar

See Power, , supra note 3, at 32.Google Scholar

See Nathan, and Goldberg, , supra note at 888.Google Scholar

This worry has been suggested to me by Susan Foster from the Alliance for the Prudent Use of Antibiotics (APUA).Google Scholar

See Spellberg, et al., supra note 22, at 168.Google Scholar

Currently, there is a whole family of statin drugs similar to Pfizer's Lipitor. There are also therapeutic alternatives to the patented drug Nexium (the second best-selling drug in the U.S. in 2007). These alternatives include Protonix (pantoprazole), Prevacid (lansoprazole), and AcipHex (rabeprazole). The third best-selling drug in the U.S. in 2007 was Advair Diskus (GlazoSmithKline). Albuterol is a therapeutic alternative to this drug.Google Scholar

See Power, , supra note 3, at 32.Google Scholar

“Lower-than-normal profits” only means profits that are smaller than the profits that pharmaceutical companies in general aim for and set as benchmarks when they make decisions about whether to discontinue R&D on a product in their pipeline. It is here worth observing that GlaxoSmithKline (GSK) in recent years has terminated further development on a number of promising earlystage antimicrobial leads because of lack-of-profit concerns. A recurring reason for the termination of work on promising antimicrobial leads was that the bacterial spectra of these leads were very limited. GSK was not interested in developing narrow-spectrum agents but was, for economic reasons, looking for broad-spectrum agents (see Payne, et al., supra note 9, at 32).Google Scholar

This is the principle of moral obligation that Power appeals to in his thoughts about the ethical responsibility of pharmaceutical companies.Google Scholar

It is here assumed that the man can swim and that by attempting to save the boy, the man does not jeopardize the life of others.Google Scholar

Maitland, I., “Priceless Goods: How Should Life-Saving Drugs Be Priced?” Business Ethics Quarterly 12, no. 4 (2002): 451–80, at 460.CrossRefGoogle Scholar

For an interesting discussion of the duty to rescue in the context of global intellectual property rights in medicine, see “Global Pharmaceutical Markets” by Kevin Outterson and Donald W. Light (Forthcoming in Kuhse, H. and Singer, P., eds., A Companion To Bioethics, 2008, 2nd ed.)Google Scholar

See IDSA report, supra note 3.Google Scholar

See Spellberg, et al., supra note 3, at 161.Google Scholar