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Bayner Genetics, the peculiar medical research firm at the center of , makes money in part by focusing on ultra-rare diseases no other company is interested in fighting; there simply aren't enough victims to make the effort profitable. Bayner does this by encouraging ultra-rich victims fosamax 35mg pills $84.00 to finance the projects, few of which bear fruit, all of which provide hope. The novel mentions in passing the U. S. Orphan Drug Act of 1983, which notes that "because so few individuals are affected by any one rare disease or condition, a pharmaceutical company which develops an orphan drug may reasonably expect the drug to generate [fosamax 35mg pills $84.00] relatively small sales in comparison to the cost of developing the drug and consequently to incur a financial loss. . . " Heaven forbid. In an effort to make the square peg of capitalism fit into the round hole of health care, the U. S. government each year gives $30 million in grants to pharmaceutical companies who deign to work on diseases with fewer than 200, 000 victims a year in the U. S. -- or diseases with more than 200, 000 victims but which have nonetheless been ignored because they're deemed so intractable it is widely assumed any program to find a treatment would be less profitable than other, lower hanging, fruit. The government also gives tax breaks to defray the cost of clinical testing and a seven-year market exclusivity -- meaning no other drug treating the same illness will be allowed, even if its chemical makeup is different, even if it's better. Not surprisingly, the law has been gamed. Even a disease with fewer than 200 fosamax 35mg pills $84.00, 000 victims this year may spread, making the incentives ultimately redundant. AZT, an early treatment for AIDS, was granted orphan drug status when the numbers were still small, even though everyone knew the numbers would explode. Although the number of treatments for rare diseases has increased, it's a drop in the bucket. The vast majority of the orphan diseases continue to be ignored. Despite the existence of a similar orphan drug program in the European Union, as of 2010 treatments had been developed for only 200 of the estimated 7, 000 orphan diseases, leaving the vast majority of the people who suffer from rare diseases -- including an estimated 20 million Americans -- out in the cold. Meanwhile, some drug companies have managed to make a killing on orphan drugs by simply setting the price high, sometimes very, very high. One company, KV Pharma, used the Orphan Drug Act to get a monopoly on a drug that had been available for years at ten bucks a pop. KV then raised the price to $1, 500 per injection. The drug prevents premature births. According to a report by US health department's inspector general, KV is being relatively nice. Some versions of human growth hormone, the IG said, can cost up to $100, 000 per year. Alglucerase, the treatment for Gaucher’s disease (an enzyme deficiency), can cost more than $300, 000 per year. That should take care of that pesky profitability problem. Here are some links you may find interesting: The Orphan Drug Act http://www. fda. gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default. Fosamax 35mg pills $84.00 htm wikipedia's orphan drug page http://en. wikipedia. org/wiki/Orphan_drug Report on the effectiveness of the Orphan Drug Act (US Dept. Health and Human Services) http://oig. hhs. gov/oei/reports/oei-09-00-00380. pdf Here's a blog post from someone who calls the ODA a failure because of the vast numbers of people it has not helped http://addiandcassi. com/orphan-drug-act-a-collosal-failure-considering-rare-disease-drug-statistics/ An interview with Jamie Love of Knowledge Ecology International, a non-profit advocacy group that focuses on intellectual property issues that affect access to medications: http://www. pharmalot. com/2011/03/kv-pharma-and-the-orphan-drug-act-jamie-explains/

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