Spam Nation by Brian Krebs Page A

retroactive to medicines created before 1995.
    Since then, the Times notes, India has emerged as the world’s pharmacy and, in recent decades, has been the largest provider of cheap, generic lifesaving medicines in poor countries across the globe. Western drugmakers have charged that by limiting drug patents in specific cases and fostering the development of inexpensive, generic knockoffs, the Indian government and the pharmaceutical industry there are stifling innovation and reducing profits that are essential to continued research and development on lifesaving drugs. The Indian drug companies saytheir practices ensure that poorer nations maintain affordable access to drugs for scourges like HIV and cancer.
    Indeed, in one high-profile legal showdown, the Indian drugmakers faced off against Swiss pharmaceutical giant Novartis in a legal battle over whether Indian firms could continue to produce generic copies of Gleevec, a drug that provides effective treatment for some types of leukemia. As the New York Times notes, Gleevec can cost as much as $70,000 per year, while Indian generic versions have sold for about $2,500 a year. In late March 2013, the Indian Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a true invention.
    The problem is that India’s admirable, if self-serving fight to produce affordable generic drugs for the rest of the world does not address the safety and efficacy of these non-brand drugs. But to hear the U.S. pharmaceutical industry tell it, any prescription drugs produced outside the so-called “approved supply chain” are counterfeit at least, probably substandard, and quite possibly harmful or lethal. Whether or not that’s always the case, the U.S. drugmakers are right about one thing: most drugs sold by rogue online pharmaceutical companies are not produced in regulated facilities—and therefore pose serious risks to anyone who decides to take them.
    The statistics about the rogue pharmaceutical industry—and their implications for the health of its customers—are truly terrifying. According to the World Health Organization, approximately 8 percent of the bulk drugs imported into the United States are counterfeit, unapproved, or substandard, and 10 percent of global pharmaceutical commerce—or $21 billion—involves counterfeit drugs. A study led by the International Journal of Clinical Practice ( IJCP ) published in 2012 puts the number at more than three times that amount. The IJCP study estimates that global sales of counterfeit medicines doubled in the five years between 2005 and 2010, and now exceed $75 billion. The Alliance for Safe Online Pharmacies estimates that 30,000 to 40,000 activeonline drug sellers operate at any given time, and that only a fraction are legitimate.
    Pharmaceutical giant Merck recently analyzed more than 2,500 Internet pharmacies and found that more than 80 percent of those sites were selling their drugs without requiring a prescription. Online pharmacies run by pharmacy affiliate networks like Rx-Promotion and GlavMed-SpamIt never asked customers to produce a prescription, although legitimate online pharmacies selling prescription drugs to Americans must by law require a prescription. What’s more, Merck discovered that nearly six hundred of those pharmacies were selling the drugs at a price below the lowest wholesale average price available to any market anywhere, strongly indicating that the drugs were counterfeit—and very possibly unsafe.
    Many people who bought from Rx-Promotion and SpamIt-affiliated online pharmacies expressed surprise at receiving their pills in packages showing that they were shipped directly from India and China. But according to a 2010 report from the U.S. Government Accountability Office (GAO), that’s where the vast majority of drugs you buy from your corner drugstore are also produced. The GAO found that roughly 80 percent of the raw ingredients that go into all pharmaceuticals—including