AIDS Experts Question Quality of Generic AIDS Drugs Manufactured by Foreign Companies
AIDS experts are "divided over whether [generic] drug manufacture in developing countries is really the best way to ease" the AIDS epidemic in developing countries, the New York Times reports. Some scientists wonder whether developing countries will be able to monitor the safety and potency of drugs and enforce manufacturing standards in order to ensure the consistent production of reliable drugs. For example, generic drugs that are not manufactured at full strength may "fail the patient and may also foster the growth of drug resistant viruses that are difficult to treat and can be passed on to other people." Without "safety nets" like the FDA, manufacturers in developing countries could be "unequipped" to test drugs. Further, if foreign manufacturing techniques alter the way an AIDS drug is absorbed in the body, its "potency could be diminished, which would harm both the patient and the community," according to Dr. Paul Volberding, professor of medicine at the University of California-San Francisco. According to a recent editorial in the Bulletin of the World Health Organization, developing countries face a "growing and underestimated threat from 'the rise in substandard medicines with concomitant problems of toxicity, instability and ineffectiveness.'"
Generic vs. Brand Name
Dr. Mark Wainberg, former president of the International AIDS Society and a professor of medicine at McGill University, said that it would be "far superior" if developing countries obtained AIDS drugs from the pharmaceutical companies that originally developed them rather than from generic drug makers, "particularly companies without proven track records." Wainberg said, "It's not only in the best interests of big pharma to want to play this role, it's in the world's best interest as well. It is ethically imperative to not treat people in developing countries with substandard versions of our drugs." However, Dr. Stafano Vella, the current president of the International AIDS Society, presented a different point of view. "I feel a little uneasy in talking about quality. There is such a desperate need for drugs. Clearly the quality is important but it's one of the points, not the major one. This is like saying: 'We need bread. It is fresh enough?' We need the drugs. From wherever they come they're welcome," Vella said, adding that his view is consistent with UNAIDS' position. He added, "I'm not saying quality is a side issue, but I would address it later on" (Grady, New York Times, 4/24).
Generics Show Low Drug Manufacturing Costs
Meanwhile, foreign generic drug manufacturers, "working in the shadows to make copycat versions of patented AIDS medicines, are shedding new light on how little these medicines cost to make," the New York Times reports. For example, GlaxoSmithKline, the world's largest manufacturer of AIDS drugs, sells Combivir in the United States for about $7,000 per patient per year. However, Indian generic drug manufacturer Cipla sells Combivir for $275 per person per year. And Bristol-Myers Squibb sells the antiretroviral Zerit, also known as stavudine, for about $3,400 per patient per year in the United States, while Cipla sells the generic version to health organizations for $40 per patient per year. Even when brand-name companies have reduced prices in developing countries to what they say is "below cost," foreign generic drug manufacturers often sell their products at even lower prices, the Times reports. The big international drug companies say they "must" charge more for their products than generic drug manufacturers because they incur "many costs the copycat manufacturers do not have," including finding and developing the medicines. But as much as these companies spend on research and development, they spend "far more" to market and advertise their products, the Times reports. For example, last year GSK spent 37.2% of its revenue on marketing and administrative costs, while it spent only 13.9% on research. And after factoring all costs, the company still maintained 27.8% of its revenue as profit. Luciano Calenti, the top executive at ACIC Pharmaceuticals, a foreign generic drug manufacturer, said, "The price the brand-name companies charge has nothing to do with the cost of making the product." In addition, AIDS drugs represent "only a small part" of big companies' total revenue, and relatively little is spent on marketing AIDS drugs because of their "high demand and because advocates for AIDS patients rapidly spread information on new drugs," the Times reports. But the "greater financial risk" these companies face after withdrawing their case against South Africa last week is that the "generic companies could find ways to sell other patented, brand-name medicines," and "expand their businesses and become a greater threat to the makers of branded drugs" (Petersen, New York Times, 4/24).
Windfall for Brazil
In other AIDS drug news, the U.N. Human Rights Commission on Monday gave a "ringing endorsement ... to Brazil's campaign to combat AIDS" with cheap generic AIDS drugs, Reuters reports. In a "non-binding vote," 52 out of 53 member countries supported a Brazilian resolution "calling on all states to promote access to AIDS therapies" by ensuring "that the application of international agreements is supportive of public health policies which promote broad access to ... affordable pharmaceutical and medical technologies." One country -- the United States -- abstained, saying that the resolution was "a flawed health document" unrelated to human rights (Evans, Reuters, 4/23). This week's Time magazine reports that the conclusion of the case in South Africa will "raise pressure" for drug companies to "back off on Brazil ... which would reinforce the principle that the intellectual property rights of drug companies can be ignored by government responding to public health crises in the developing world" (Karon, Time, 4/23). The U.S. government and the Pharmaceutical Research and Manufacturers Association of America have filed a complaint with the World Trade Organization against Brazil, arguing that the country, which manufactures cheap copies of patented AIDS drugs, is violating the Trade Related Aspects of Intellectual Property Rights agreement ( Kaiser Daily HIV/AIDS Report, 4/19).