HIV/AIDS has burgeoned into a nation-crippling pandemic -- concentrated in developing nations -- while drug companies hold out for profits. Yet, in times of "national emergency," nations can ignore drug patents using a regulatory loophole. Known as compulsory licensing, some nations buy or make massive amounts of generic anti-virals without paying royalties. So while big pharmaceuticals cry foul, HIV transmission rates spiral downward in countries using "pirated" generics. Stricken nations frame the argument as lives vs. profits. Major pharmaceutical firms argue their need for income to perform research, development and marketing. Are we cheating big pharmaceuticals? Let's take a quiz. True or false: HIV/AIDS drug cocktails would be widely available except for the massive research and development involved. The answer is false. Many of the major anti-virals were developed with federal money in partnership with universities. The finished drugs were then licensed to major pharmaceutical firms to mass-produce and market. For example, dideoxyinosine, or ddI, is produced by Bristol-Meyers Squibb as Videx, an important anti-viral. But the National Institutes of Health discovered its use as an HIV/AIDS therapy. Now, NIH licenses the drug to Bristol-Meyers Squibb for a small royalty, provided that BMS "takes into account the health and safety needs of the public." ddI, meanwhile, is used as a highly effective treatment for adults and children who are unresponsive to AZT. True or False: Because U.S. pharmaceutical firms developed these drugs, they have the absolute right to profit from them. False. d4T, or stavudine, is marketed as Zerit by Bristol-Meyers Squibb, which derives most of the drug's profits, even though it was discovered by the Michigan Cancer Foundation in 1966 using public funds. Yale applied it to HIV/AIDS using federal money, with minimal input from BMS. But Yale holds the patent for d4T in recognition of its researchers' work. True or false: The public will experience a negative effect in future drug development if HIV/AIDS drugs are sold as generics. Again, false. Taxpayers funded the bulk of HIV/AIDS anti-viral development and continue to do so. Next, small intermediary drug firms step in, often betting on the promise of only one or two compounds to complete the next phase of drug development. Often, small pharmaceuticals do the lion's share of the research and development once the compound has shown promise at the university level. For example, 3TC, which is marketed as Epivir by GlaxoSmithKline, was discovered and patented for HIV/AIDS by BioChem Pharma, a Canadian pharmaceutical, which licensed 3TC to Glaxo. After the drug was given a snazzy name and released in a blur of marketing overkill, we started experiencing exponential pricing. Doctors are feted with free vacations by the big pharmaceuticals, for instance. Drug reps meet with doctors regularly to schedule trips to enticing locales, paid for by big pharmacy. Naturally, drug mark-up must be quite high. How high? Cipla Ltd., an Indian generic HIV/AIDS drug manufacturer, recently donated drug cocktails to Doctors Without Borders at a cost of $350 per patient per year. The identical cocktail in the U.S. sells for between $10,000 to $15,000 per patient per year. Cipla intends to sell the cocktail on average for $600 per patient per year to any country willing to buy it. But herein lies the rub. Countries must be willing to assert their right to request compulsory licensing. It allows minimal royalty payment in time of national emergency for intellectual property. Brazil is currently invoking the doctrine at the World Trade Organization, while simultaneously producing generic anti-virals. Prices of anti-virals that have a Brazilian generic counterpart recently plummeted 79 percent, according to author Tina Rosenberg. Anti-virals without a generic counterpart remained at about the same price. Most remarkably, estimates by the World Bank in 1994 projected Brazil's HIV-positive population at 1.2 million by 2000. Brazil actually has only half that many, in a striking turnaround that has become the global model to fight the disease. Anti-virals dramatically decrease transmission by lowering viral loads to undetectable levels. Brazil has strong, vocal HIV/AIDS advocacy groups that demanded a government health care response network nationally. And they got it. Let's strongly advocate for compulsory licensing while making generic anti-viral cocktails available during the legal quibbles. "We are talking of a Holocaust-like situation," Cipla Director Amar Lulla said with regard to compulsory licensing. There is no need for a global AIDS pandemic. We have already closed our eyes for too long.Comments powered by Disqus
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