Treatment Action Campaign (TAC) Newsletter 30 January, 2001 Dear Readers This is the first newsletter of 2001. The major upcoming events are the interfaith service at St Georges Cathedral, in solidarity with Nkosi Johnson, followed by the march to parliament on the 12th of February and the international day of action against the pharmaceutical industry's legal action against the South African government on the 5th of March. Please help organise and participate in these events. Overseas subscribers, please organise activities in your countries for the 5th of March. American subscribers, some people to contact in this regard are: Julie Davids (jdavids@CritPath.Org), Gregg Gonsalves (GGonsalves@GMHC.com), Mark Harrington (Alacran7@aol.com), among others. Regards, Nathan Geffen Email: info@tac.org.za Website: www.tac.org.za In Brief Section **************** BRIEF: TAC calls on South African Civil Society to join in the interfaith service at St Georges Cathedral followed by a march to parliament on 12 February. The interfaith service is in solidarity with Nkosi Johnson and will begin at 12:00 for 12:30. The march will have the following three closely related messages: 1. Produce Generic HIV/AIDS medicines. 2. Support the the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 that the government has introduced. Demonstrate against the drug companies for taking the government to court over this legislation. 3. Increase the Provincial Health and Welfare Budgets to R33 Billion each. BRIEF: TAC calls on people in every country to mobilise against drug company profiteering on Monday 5 March 2001. On this day, the action by more than 40 multinational drug companies against the South African government will be heard in the Pretoria High Court. TAC specifically calls on our allies Medecins Sans Frontieres, HealthGap Coalition, ACTSA and all the organisations who endorsed the Global March for HIV/AIDS Treatment Access to mobilise. A victory for the drug companies in this case will set back the struggle for access to essential medicines in all countries. TAC will mobilise actions against drug companies throughout the week 5-12 March 2001. BRIEF: TAC has produced fact sheets on Tuberculosis, the Brazilian treatment model and the cost-effectiveness of mother-to-child transmission prevention. These are currently available in RTF or MS Word format. These can be requested from info@tac.org.za. DEPTH: Four articles are reprinted with relevance to treatment access and the court case. The first is from the New York Times, the second from Woza (South African internet news service), the third from the Nation (based in Nairobi) and the last is from the Oxfam Campaigner. (See In Depth section.) DEPTH: An article by Stephen Lewis, former deputy head of UNICEF is reprinted from the Canadian Globe & Mail. (See In Depth section.) DEPTH: From Health-e, a generic pharmaceutical company has won a court battle against GlaxoSmithKline in South Africa regarding the production of an anti- biotic. (See In Depth section.) DEPTH: An article from Bayerwatch about an illegal drug trial conducted by Bayer in the UK. (See In Depth section.) ################ In Depth Section ################ From the New York Times, Sunday 28 January (copied for fair use): How to Solve the World's AIDS Crisis Patent laws are malleable. Patients are educable. Drug companies are vincible. The world's AIDS crisis is solvable. By TINA ROSENBERG Someday, we may look back on the year 2001 with nostalgia for a time when AIDS was merely a health catastrophe. Soon, AIDS in Africa will be doing more than killing millions every year. It will destroy what there is of Africa's economy and cause further instability and, perhaps, war. In the year 2010, the country of South Africa will be almost one-fifth poorer than it would have been had AIDS never existed. Throughout Africa, the disease has ravaged the young, urban and mobile. It has robbed schools of their teachers and hospitals of their doctors and nurses. Businesses are depleted by the need to cope with sick and dying employees. AIDS takes the breadwinner, leaving millions of destitute elderly and orphans who will grow up without going to school, many on the streets. As they lose their productive citizens, the nations themselves face collapse. At the moment, however, AIDS in Africa is only a plague of a severity not seen since the Black Death killed at least a quarter of Europe in the 14th century. A 15-year-old in South Africa has a better than even chance of dying of AIDS. One in five adults is infected with H.I.V. Hospitals are filled with babies so shriveled by AIDS that nurses must shave their heads to find veins for intravenous tubes. Seventeen million people have died prolonged and miserable deaths from AIDS, and that number is dwarfed by what lies ahead. While Africa is the region most ravaged, the disease is exploding elsewhere as well. India says it has four million infected; it may well have five times as many. Its AIDS epidemic bears a terrifying resemblance to South Africa's a few years ago -- AIDS is widespread in every risk group, and health care is inadequate. The Caribbean has the second-highest rate of infection after sub- Saharan Africa. More than one in 50 adults is H.I.V.-positive, and because the epidemic is primarily spread heterosexually there, most of the population is at risk. In Eastern Europe and the former Soviet Union, the number of infected nearly doubled in the last year. Until a year ago, the triple therapy that has made AIDS a manageable disease in wealthy nations was considered realistic only for those who could afford to pay $10,000 to $15,000 a year or lived in societies that could. The most that poor countries could hope to do was prevent new cases of AIDS through educational programs and condom promotion or to cut mother-to-child transmission and, if they were very lucky, treat some of AIDS's opportunistic infections. But the 32.5 million people with H.I.V. in the developing world had little hope of survival. This was the conventional wisdom. Today, all of these statements are false. The Raphael de Paula Souza hospital sits on the outskirts of Rio de Janeiro. It is a one-story plaster building with peeling blue paint and barefoot boys playing in the parking lot. Nothing in its appearance suggests that it might serve as a model for treating AIDS worldwide. The AIDS clinic is run by Ademildes Navarini, who spends her days seeing patients like Rogério. He is 26, has tuberculosis as well as AIDS and suffers from an AIDS-related brain infection, toxoplasmosis. The infection has affected his speech, and now he gropes for words. He removes his T-shirt using only his left arm. His right arm and his right leg hang limp. Rogério is followed by Jerdinete, a 46-year-old middle-class woman who came in for tests a year ago because of stomach problems -- and was stunned to find she had AIDS. The only way she could have got it, she says, was from her husband, whom she had presumed faithful. When she told him that she was sick, he left her. Jerdinete is followed by Maura, H.I.V.-positive but asymptomatic, and her 7- year-old son, Emerson, whose H.I.V. was diagnosed 10 months ago but has undoubtedly been infected since birth. Emerson, a handsome, curly-haired boy, kisses his mother's cheek, puts his arm around her neck and caresses her face as she sits on a stool. A year ago, Emerson's hair started to fall out. He got diarrhea and started losing weight. The family went in for testing, and their fears were confirmed. Maura, whose husband also has AIDS and tuberculosis, stopped working to stay home with Emerson. "He's the reason for my life," she says, squeezing her son. If Rogério, Jerdinete and Emerson lived in any other poor nation, their future would be achingly foreseeable. But here's the news from Raphael de Paula Souza hospital: each of these patients will walk out with a plastic bag filled with bottles of antiretrovirals -- AZT and ddI and the protease inhibitors and other components of the triple cocktail that, for the lucky, have turned AIDS into a chronic disease. Rogério, who started taking triple therapy three weeks before I met him, has gotten much better. He will be scarred by toxoplasmosis, Navarini says, but will improve a little more. Jerdinete and Emerson, on triple therapy for months, are doing fine. And Ademildes Navarini is the happy exception in third-world medicine, an AIDS doctor who can make her patients healthy again instead of merely holding their hands and watching them die. Since 1997, virtually every AIDS patient in Brazil for whom it is medically indicated gets, free, the same triple cocktails that keep rich Americans healthy. (In Western Europe, no one who needs AIDS treatment is denied it because of cost. This is true in some American states, but not all.) Brazil has shredded all the excuses about why poor countries cannot treat AIDS. Health system too fragile? On the shaky foundation of its public health service, Brazil built a well-run network of AIDS clinics. Uneducated people can't stick to the complicated regime of pills? Brazilian AIDS patients have proved just as able to take their medicine on time as patients in the United States Ah, but treating AIDS is too expensive! In fact, Brazil's program almost certainly pays for itself. It has halved the death rate from AIDS, prevented hundreds of thousands of new hospitalizations, cut the transmission rate, helped to stabilize the epidemic and improved the overall state of public health in Brazil. Brazil can afford to treat AIDS because it does not pay market prices for antiretroviral drugs -- the most controversial aspect of the country's plan. In 1998, the government began making copies of brand-name drugs, and the price of those medicines has fallen by an average of 79 percent. Brazil now produces some triple therapy for $3,000 a year and expects to do much better, and the price could potentially drop to $700 a year or even less. Brazil is showing that no one who dies of AIDS dies of natural causes. Those who die have been failed -- by feckless leaders who see weapons as more alluring purchases than medicines, by wealthy countries (notably the United States) that have threatened the livelihood of poor nations who seek to manufacture cheap medicine and by the multinational drug companies who have kept the price of antiretroviral drugs needlessly out of reach of the vast majority of the world's population. But one major reason that only Brazil offers free triple therapy is that, until now, there was no Brazil to show that it is possible. A year and a half ago, practically nobody was talking about using triple therapy in poor countries. Today, it is rare to find a meeting of international leaders where this idea is not discussed. International organizations like the United Nations AIDS agency, Unaids, and nongovernment groups like Médecins Sans Frontières are starting to help countries try to replicate Brazil's program. Brazil has offered to transfer all its technology and provide training in the practicalities of treating patients to other countries that want to make drugs and will supply them to patients free. Even the drug companies, hoping to head off more damaging assaults on their patent rights and improve their tattered image, have acknowledged the need to charge less for their products in poor nations. They have begun to make limited offers of cheap drugs. In other words, the debate about whether poor countries can treat AIDS is over. The question is how. Pharmaceutical manufacturers argue that many countries are very far from able to administer a program of triple therapy, and they are right. But Brazil shows that poor nations can do it. Others will be able to follow if they get substantial international help. The drug companies are wrong, however, on how to make AIDS drugs affordable. Their solution -- limited, negotiated price cuts -- is slow, grudging and piecemeal. Brazil, by defying the pharmaceutical companies and threatening to break patents, among other actions, has made drugs available to everyone who needs them. Its experience shows that doing this requires something radical: an alteration of the basic social contract the pharmaceutical companies have enjoyed until now. By the terms of that contract, manufacturers, in return for the risks of developing new drugs, receive a 20-year monopoly to sell them in some nations at whatever prices they choose. The industry has thrived under this contract. And so have we, the rich. The system has conquered an unimaginable range of diseases. But for billions of people the medicines have remained out of reach. Poor countries, it is now clear, must violate this contract if they are to save their people from AIDS. Brazil has been able to treat AIDS because it had what everyone agrees is the single most important requirement for doing so: political commitment. At the beginning of 1999, Brazil's economy was skidding into crisis. President Fernando Henrique Cardoso was under great pressure to cut the budget by abandoning the AIDS program. He rejected that advice, deciding that treating AIDS was a priority. Such commitment has its roots in the gay community. Although AIDS is now a disease of the poor in Brazil, the first Brazilians infected were gay men. In a country famously open about matters sexual, gays were much more activist and better organized than in most other nations, and AIDS carried less of the stigma that has elsewhere led people simply to deny its existence. Then the movement found an unlikely ally in José Sarney, Brazil's first civilian president after the country emerged from military rule in 1985 and a conservative who led a pro-military party during the dictatorship. In 1996, scientists at the world AIDS conference in Vancouver announced that triple therapy with a protease inhibitor could reduce viral load to undetectable levels. Finally, there was a treatment for AIDS. "A doctor friend informed me about what was going on in Vancouver," Sarney told me. "I saw that most of the medicine in the cocktail would not be available to the poor, and I felt that we were talking about the survival of the species." Sarney proposed a law that guaranteed every AIDS patient state-of-the-art treatment. It passed. At the same time, Brazil was carrying out an aggressive AIDS prevention program, financed by the World Bank. Activist groups were the keystone, distributing millions of free condoms. Surveys show that there are about 530,000 H.I.V.-positive people in Brazil. Four-fifths do not know they are infected. Of those who have been identified as needing antiretroviral therapy, however (some 90,000 at the moment), virtually all can get it, even homeless people, even people in the middle of the Amazon, says Paulo Teixeira, who runs Brazil's AIDS program. A slim, elegant man of 52, Teixeira has been an AIDS doctor since 1983 and director of the country's AIDS efforts for a year. The treatment and prevention programs complement each other -- another powerful reason to begin treating AIDS in poor countries. Treating AIDS helps to limit its spread, as people with a lower viral load are less contagious. The availability of lifesaving treatment is also a powerful lure for people to get an AIDS test. "Treatment brings people into the hospital, where you can talk to them," says Serafim Armesto, a psychologist who works with AIDS patients at the General Hospital of Nova Iguaçu, a major hospital in a working-class town a short drive from Rio. "You can work with them to prevent the spread of AIDS and further disease." The programs have paid off. In 1994, the World Bank estimated that by 2000 Brazil would have 1.2 million H.I.V.-positive people. In fact it had half that many. The epidemic has stabilized, with some 20,000 new cases each year for the last three years. The treatment program has cut the AIDS death rate nationally by about 50 percent so far, and each AIDS patient is only a quarter as likely to be hospitalized as before. Treating AIDS also fights other diseases. The incidence of tuberculosis in H.I.V.-positive patients has dropped by half. AIDS has also helped to mobilize people to fight for better health care. "In 1999, the Health Ministry had problems getting its budget passed for AIDS, TB and other diseases," says Pedro Chequer, Teixeira's predecessor as head of the AIDS program and now the Unaids director for the southern part of South America. "There are now 600 nongovernmental groups that work on AIDS. They demonstrated in the street for a higher budget for all diseases, not just for AIDS, and these protests were covered in the press." The money was restored. The Health Ministry spent $444 million on AIDS drugs in 2000 -- 4 percent of its budget. The only study of the program's benefits so far shows that the decline in hospitalizations from opportunistic infections from 1997 to 1999 saved the Health Ministry $422 million. But the tally of benefits should also take into account the savings from treatment's contribution to a halving of the expected infection rates and the productivity of those who no longer need to stay home or care for the sick. "When we started with triple therapy," Teixeira says, "the main criticism from developed countries was that we didn't have the conditions for antiretroviral treatment. They said it would be dangerous for other countries, that we would create resistance." Antiretrovirals, if taken incorrectly, can indeed create a more resistant strain of virus in the patient -- and in anyone to whom it is transmitted. Patients must stick to a rigorous and complicated schedule of pills, some taken with food, some without, and they must keep to this program (at least this is the current thinking) every day for the rest of their lives. Yet the worries of rich countries that the poor and uneducated will mess things up for the rest of us have proved unfounded. Any nation that provides its AIDS patients with antiretrovirals must also provide them with help and training to take the medicine correctly. Brazil is doing just this, although it has meant turning nurses into organizers of nature hikes and clinics into baby-formula warehouses. In Ademildes Navarini's clinic at Raphael de Paula Souza hospital, a nurse's aide, Denise Feliciano, spends a large part of her day drawing suns and moons with a purple marker. Today she is preparing Rogério, the patient recovering from toxoplasmosis, to go home with a bag of medicine. Rogério has been taking antiretrovirals for three weeks, and he may or may not be taking them correctly. "What time do you take your pills?" she asks. She waits while he counts. He stops at 6, groping for the next number. Seven? she supplies. Eight? Rogerio makes a noise at 8. How many pills do you take at 8 at night? "Three," he says, but he is holding up two fingers. It is not clear whether Rogério is confused or merely has trouble expressing himself. The toxoplasmosis has also affected his eyesight; he knows how to read, but he can't see. Feliciano sits down next to him and takes out his bag of medicine, a sheet of paper and her marker. "O.K., how do you take Biovir?" she says. They go through each drug, with Feliciano drawing suns and moons on the boxes of pills and making a list on a separate sheet in a large purple hand. She estimates that 30 percent of patients have trouble keeping to their schedules, the same figure I heard from doctors and health workers at other hospitals. Most patients, everyone agreed, eventually understand how to take their medicine. But that doesn't mean they take it. "Many don't understand the need for treatment, and they abandon it at the first side effects," says Armesto, the psychologist in Nova Iguaçu's clinic. "It can become a vicious circle -- no food, no money -- so they can't take their medicine properly, so they get opportunistic diseases, so they can't work, they get depressed, and that leads them further away from treatment." In 1999, the AIDS program conducted a survey of more than 1,000 patients in São Paulo. It found that 69 percent achieved 80 percent adherence, which means they took their medicine properly 80 percent of the time. According to Margaret Chesney, a professor of medicine at the University of California at San Francisco who studies behavioral factors in AIDS treatment, this rate is not sufficient to control the virus - which can kill even people who take their medicine faithfully - but it is no different from adherence rates in the United States. A study in San Diego showed that 72 percent of patients took their medicine 80 percent of the time. The São Paulo study found that the most important factor in patient falloff was missing a doctor's appointment. Next came the level of instruction and support available at the clinic, followed by a patient's income and education. ''Patient adherence depends directly on the quality of the services provided,'' Teixeira says. ''People in bad economic situations have more difficulties, but we can overcome them if we provide good service.'' The study reinforced Brazil's attempt to offer patients more sustained and varied help. AIDS officials expanded their training programs for people who work with patients. AIDS sufferers get free bus passes. Clinics ask local churches and Lions Clubs for food and baby formula. They recruit patients to sit in the waiting room and talk with other patients about their problems and to run Alcoholics Anonymous-style groups. The nurse at Nova Iguau recently took one group on a nature hike to a waterfall, because the patients seemed to be getting depressed. ''When we realize the patient is no longer coming to appointments, we send a telegram to ask them to come in and tell us why they stopped,'' says Rosa Maria Rezende, the social worker in Nova Iguaçu's clinic. ''Then we try to overcome that. We want them to be more interested in the struggle to live. It is not their attitude toward medicine that matters; it is their attitude toward life.'' At first glance, it would seem that brazil has advantages that are hard to duplicate. It has a well-organized network of civic groups, which were essential to building support for the program, designing it and making it work. It is a big country, with a large market for drugs. It has a health care system, however patchy. And while it is a poor country, it is a rich poor country. Some countries will be unable to follow - they are too corrupt or war-torn or venally governed or not governed at all. In many of the African nations most ravaged by AIDS, the annual health budget comes to less than $10 per capita. This reflects the twisted priorities of leaders, many of whom can find sufficient money when they need to buy weapons. And health care is worsening thanks to AIDS itself, as doctors and nurses are among those most ravaged by the disease. But millions and millions of AIDS patients live in countries that could emulate Brazil, although they would need international help. These include virtually all the countries of Latin America and Eastern Europe, most of Asia and the former Soviet Union and at least 10 countries in sub-Saharan Africa. Pilot programs in Ivory Coast and Uganda show that at well-run clinics, patients have the same rate of adherence as in Europe and the United States. Brazil shows how a nation can create an AIDS infrastructure atop an unstable foundation. Fairly good in Brazil's rich regions, health care is bad to nonexistent in poor ones. The country has one of the lowest rates of life expectancy and highest rates of infant mortality in Latin America. ''When we passed the bill, we had to rely on a distribution network that didn't exist,'' former President Sarney says. It seems absurd to suggest that countries that will not spend 10 cents to cure an infant with diarrhea should spend thousands of dollars on her mother's AIDS drugs. But in Brazil, there has been no trade-off. The program has very likely saved the Health Ministry money, improved the treatment of other diseases and - very important - fostered a vocal lobby for better health care. For countries with a poor health infrastructure, an internationally financed AIDS program could be a way to develop a network of clinics and trained workers who might also be able to cure diarrhea. So why have other countries not done it? One reason is indifferent, or even hostile, leadership. Kenya's president, Daniel Arap Moi, only very recently reversed his opposition to condom use. AIDS carries such a stigma that the response of some African leaders has been to deny there is a problem. Other governments are too corrupt or incompetent to organize prevention programs, much less treatment. But for most countries, even middle-income poor countries, the biggest hurdle is cost. Whether AIDS treatment eventually pays for itself is irrelevant; they cannot afford to get started. Nowhere are the lost opportunities more tragic than in South Africa. According to Unaids, South Africa has more than four million infected, and the epidemic is growing geometrically. It is a wealthy country by African standards, with a relatively good health infrastructure and laboratories that could manufacture generic drugs. But South Africa has done nothing to treat AIDS. The biggest obstacle is President Thabo Mbeki, in other ways a sane and responsible leader, who has inexplicably decided that he is not convinced H.I.V. causes AIDS. Absurdly, it has become politically incorrect to talk about treating AIDS in South Africa - because it would acknowledge that H.I.V. is the cause. Mbeki's musings, as well as an intense political battle in South Africa about the country's AIDS priorities, delayed the institution of even a program to cut mother-to-child transmission. India, the country that probably has the largest epidemic, is another dismaying example. India does not recognize patents on medicine, and world trade rules do not require it do so until 2005. Indian firms lead the world in the manufacture of generic AIDS drugs. The managing director of Cipla Ltd., an Indian generic manufacturer that meets international quality standards, told me in December that he could make a triple therapy for $500 per year, plus another $200 in packaging costs, ''and prices are likely to come down as we improve our techniques.'' Does India provide its sick with free AIDS treatment? It does not. But treating AIDS is gradually creeping into the realm of the possible for many countries. AIDS is now bad for business in Africa, and African leaders are hearing a clamor for treatment from the middle class. Several African countries have good prevention programs, which was all they believed possible to do. Now they are starting to think about treatment as well. While Brazil's ability to reach patients encourages other nations, far more important is its success in lowering the cost of medicine. This is the news that can now allow other countries to dream about treating AIDS. Eloan Pinheiro is a soft-spoken, ever-smiling 55-year-old chemist who spent the first part of her career as chief of formulation for the Brazilian subsidiaries of two multinational drug companies. Now Pinheiro is tormenting her former colleagues. She is the director of Far-Manguinhos, a government pharmaceutical research lab and factory named for the industrial neighborhood of Rio where it is located. In 1998, with the costs of importing brand-name drugs mounting, Brazil's health minister asked Pinheiro to analyze and copy the world's major AIDS drugs. Far-Manguinhos and Brazil's six other state pharmaceutical factories now make seven of the 12 antiretrovirals taken by Brazilians with AIDS. Pinheiro buys raw materials from India and Korea. From the drug companies' point of view, the assembly lines below Pinheiro's second-floor office are humming with the violation of intellectual property rights, 40,000 times an hour. Brazil's 1996 law recognizing patents on medicine, passed to comply with the rules of the World Trade Organization, specifies that anything commercialized anywhere in the world by May 14, 1997, would forever remain unpatented in Brazil. That covers a lot - all the first-generation antiretrovirals like AZT, ddI, d4T, 3TC. It covers nevirapine, one of the nonnucleoside reverse transcriptase inhibitors, which, like protease inhibitors, make up the third drug in the triple cocktail. And by a few weeks, it covers the protease inhibitor indinavir. And at the end of last year, Brazil was causing tremors in the pharmaceutical industry by preparing to produce copies of Stocrin, a Merck antiretroviral that came out after 1996, which is patented in Brazil. Since Brazil started making generics of AIDS drugs, their cost has plummeted. The price of AIDS drugs with no Brazilian generic equivalent dropped 9 percent from 1996 to 2000. The price of those that compete with generics from Brazilian labs dropped 79 percent. But just the credible threat of generic competition is enough to get manufacturers to lower their prices. There is no legal reason that other countries cannot do the same. Most drugs, including antiretrovirals, have never been patented in most sub-Saharan African countries, so those countries are free to make or import generics. Even countries that do respect patents on medicines have this possibility. This is important, because every country joining the World Trade Organization must pass laws respecting medical patents - the reason Brazil did. But there is a W.T.O. loophole that allows countries to make copies of patented items in certain situations, including that of a national emergency. According to a W.T.O. official, governments could also choose to import generic drugs instead of making them. They can get what is called a compulsory license - in effect, they seize a patent - and manufacture or import a generic copy of a drug, paying the patentholder a reasonable royalty. Of all the tools available to poor countries, compulsory licensing is what the drug companies fear the most, since it represents the most direct assault on control of their patents. The United States has issued compulsory licenses in situations far less dire than those of AIDS-ravaged poor nations. Recent ones have been for tow trucks, stainless-steel wheels and corn seeds. Such licenses are common remedies in antitrust cases. But although trade rules provide legal ways for poor nations to get cheap medicine, there are other obstacles. Many do not even know it is legal. Countries that have tried to manufacture generic medicine have fallen under debilitating pressure from pharmaceutical companies and from Washington. In Thailand, such pressure kept the government from making cheap antiretrovirals until last year. Thailand has long made zidovudine, the knockoff of Glaxo Wellcome's AZT. But two drugs are needed to slow AIDS, and Thailand was blocked from making the other components of dual therapy - ddI, d4T and 3TC. Bristol- Myers Squibb sells ddI and d4T under the brand names Videx and Zerit. Glaxo sells 3TC under the name Epivir. None of the three were patented in Thailand because they came out before 1992, when the nation passed patent protections for medicine. Thailand's state drug factory was preparing to produce generic ddI when Bristol obtained a patent on the antacid buffer used to pack Videx into pill form. Krisana Kraisintu, the head of the factory, told me that Bristol also prevented the producers of the raw materials for ddI from selling to her. She was only able to make a generic ddI - in powder form - recently. (Bristol failed to respond to questions despite repeated requests over the course of a month.) With Zerit and Epivir, Bristol and Glaxo took advantage of a controversial safety monitoring period passed in 1993 at American urging. It gives drugs up to five or six years of market exclusivity while generics undergo special safety tests - a law the World Health Organization and Unaids says ''unnecessarily delays generic competition.'' Thailand was able to make generic d4T only when Zerit exited the program last year and is only now beginning to make generic 3TC. The drug companies' actions are particularly distasteful because neither Bristol nor Glaxo invented these drugs or discovered their use in AIDS therapy. Glaxo's 3TC was discovered and patented for AIDS use by BioChem Pharma, a Canadian company, which licensed the drug to Glaxo. d4T was synthesized by the Michigan Cancer Foundation in 1966, using public funds. Its application for AIDS was discovered at Yale University, which holds the patent, using grants from the federal government and Bristol. In the United States, Bristol's Zerit sells for $4.50 for 40 milligrams. Pharmaceutical manufacturers never disclose their costs, but one indication of Bristol's markup is that Pinheiro can sell her version for 30 cents - and it is possible her costs are higher than Bristol's, since the multinationals have access to cheaper raw materials. The National Institutes of Health discovered ddI's use as an AIDS therapy. The N.I.H. then licensed the drug to Bristol for a 5 percent royalty, with the stipulation that Bristol's pricing take into account the health and safety needs of the public. But Bristol sells Videx for $1.80 in the United States for a 100- milligram tablet, while Far-Manguinhos in Brazil can sell the generic equivalent for 50 cents. The contract has a fair-pricing clause, but it has never been enforced. The drug companies' influence has been greatly magnified because the United States trade officials have put the full weight of American trade pressures to work on their behalf. And one official told me that until very recently, ''it was pretty rare'' that his agency ever considered the health consequences. The statements in the trade representative's annual reports and trade watch lists document a shameful history of successful American efforts to get Thailand to pass patents on medicine, to abolish the pharmaceutical review board that monitored drug prices, to pass the safety monitoring period of market exclusivity and to refrain from issuing compulsory licenses. Here is one example from the trade representative's 1997 national trade estimate for Thailand: ''The Thai legislature is expected in 1997 to consider a bill abolishing the pharmaceutical review board. This measure would advance objectives of American manufacturers." Numerous countries have been placed on the trade representative's Special 301 Watch List because of pharmaceutical patent disagreements. The list is a precursor to trade sanctions, but simply appearing on it is a form of sanction because it discourages investment. It turns a country's business sector and commerce ministry against generic production - and with such powerful opposition, local health officials lose. ''When I wanted to produce generics, I was told, 'Don't move, because we're afraid of trade retaliation,''' Kraisintu says. ''All of us know that the reason for all these things is pressure from the United States and multinational companies.'' Thailand sells a fifth of its exports to the United States. The drug industry's dominance over American trade policy on pharmaceuticals finally crashed over South Africa. In 1997, South Africa, which does respect pharmaceutical patents, amended its laws to allow compulsory licensing of essential medicines, including AIDS drugs. Pharmaceutical companies sued. The suit is still going on. Although Clinton administration officials acknowledged that what South Africa proposed was legal under the World Trade Organization, it declared war. President Clinton and Vice President Gore lobbied their counterparts, Nelson Mandela and Thabo Mbeki, then the deputy president. Friends of the drug companies in Congress passed a requirement that the State Department report on Washington's efforts to stop South Africa before the country could receive American aid. It reported in February 1999, that ''all relevant agencies of the U.S. government . . . have been engaged in an assiduous, concerted campaign to persuade the government of South Africa to withdraw or modify'' the relevant parts of the law. This was a bizarre policy for an administration that claimed a special relationship with South Africa. But there was no role in the process of decisions about trade pressures for voices that countered those of industry. This resulted in egregious blind spots. In August 1998, I talked with an American trade official who worked on South Africa's medicines act. He told me that until a few months before I spoke to him, he was unaware of the dimensions of South Africa's AIDS problem. ''Nobody brought it to my attention that it was a major health crisis,'' he said. Today, this official is better informed. The administration changed its policy after activist groups began heckling Vice President Gore at his campaign appearances. When reporters, and later Gore aides, began to take notice, the administration told South Africa it could issue compulsory licenses for essential medicines as long as it stayed within world trade rules. Over the next year, the administration announced that health officials would participate in decisions about pharmaceutical disputes and pledged not to block compulsory licenses in the rest of sub-Saharan Africa and Thailand and in other countries on a case-by-case basis. But pressure from other parts of the administration continued. In February 2000, William Daley, then the commerce secretary, traveled to Brazil and Argentina with Raymond Gilmartin, the C.E.O. of Merck, and a vice president of Pfizer in tow. Before he went, Daley told students that one purpose of his trip to Brazil was to talk about ''serious concerns our companies have'' with medical patent laws. In Argentina, he threatened trade sanctions over the issue. Overall, however, the Clinton administration went through a real conversion. Countries that displease American pharmaceutical manufacturers no longer land on a trade watch list if the trade representative believes they have a health emergency. But this could be reversed in five minutes by President Bush - and probably will be, since the industry is likely to be even more influential in the Bush administration than it has been under President Clinton. Pharmaceutical manufacturers give money to both political parties - $23 million in the last election cycle, according to the Center for Responsive Politics - but 69 percent of it went to Republicans. The drug industry also spends $75 million or so on lobbying every year. From the beginning of the aids epidemic, the major drug makers clung to the idea of one planet, one price. Or worse - some drugs cost more in Kenya than in Norway. The strategy has earned them a public image almost as malignant as that of tobacco companies. By last year, they were also facing the growing threat of generics and the loss of Washington's automatic trade support. Early in 2000, several companies began to discuss the idea of lowering their prices in the third world. In May 2000, Glaxo Wellcome, Merck, Boehringer-Ingelheim, F. Hoffmann-La Roche and Bristol announced a program called Accelerating Access, promising to sell drugs at deep discounts to poor countries that met certain standards. The price cuts the drug companies fought until last year have now become their solution to the world's AIDS crisis. The companies have restricted their discounts, demanding that recipient countries properly administer the medicine. But the restrictions also keep the program small, controlled and largely secret. Each price cut for each drug in each country is negotiated separately. Glaxo was the only company to specify a price reduction publicly, announcing it would cut Combivir from $16 to $2 a day. And while about 20 countries are talking to the drug companies, only Senegal and Uganda have so far signed agreements to receive cut-price antiretrovirals. The discounts are impressive - Senegal will be able to buy triple therapy for as low as $1,000 per year per person. But just a few hundred people will benefit, most of them rich enough to pay themselves. In Uganda, about a thousand people will get the drugs, but they will all pay for them. The pharmaceutical industry argues that collaborative efforts like this one are the way to make AIDS medicine affordable in the third world. But the program is too crabbed. ''Why don't they just lower their prices in poor countries?'' asks Ellen 't Hoen, who works in the Médecins Sans Frontières campaign to help poor countries get needed medicines. ''Having country-by-country confidential negotiations is not justified. This way, it stays in the charity corner and it hampers the development of more sustainable ways to get medicines to people.'' The industry's control over the program serves another purpose: the companies can use it to head off the practices they fear most, chiefly compulsory licensing. The document announcing the plan calls on the recipients of their largess to ''respect intellectual property'' - code for ''stay away from compulsory licensing.'' And countries are complying, many of them out of ignorance. Every single drug company executive I spoke with argued that if countries turn to compulsory licensing, new discoveries could eventually slow. ''If we are to continue with research and development, then countries that participate in the program must provide conditions basic to innovation,'' Tadeu Alves, the chief of Merck's Brazil subsidiary, said during a panel at an AIDS conference in Rio. Those conditions, he said, included a free market, price structures that provide incentive to innovation and respect for intellectual property. The drug companies' argument is in essence a defense of high profits. Even in the United States, the cost of drugs is provoking questions about whether continued research and development really depends on giving companies a 20-year monopoly to charge whatever price they choose, especially since they are often marketing other people's discoveries. The manufacturers generally spend twice as much on marketing and administration as they do on research and development. The real threat that third-world generics pose to pharmaceutical companies is that of blowback in rich nations. They worry that publicity about generic prices will fuel the American demand for cheap imports or price controls. They fear that patent seizures in the third world could loosen intellectual property rights in the first world. Innovation would certainly suffer if pharmaceutical manufacturers could not charge high prices in their primary markets, although how high is open to debate. But applying this argument to Ukraine or Uganda is a scare tactic. No manufacturer depends on profits in Africa, which will account for 1.3 percent of worldwide drug sales next year, to motivate the search for new medicines. And companies can sell their AIDS drugs at very steep discounts - some at 90 percent or more off the American price - and still profit. Once they realized that Brazil was solidly behind its generic drug program, the pharmaceutical companies have made the best of it, and they have not suffered. In fact, the government is buying 20,000 daily doses of Crixivan (Merck's brand of indinavir), a tenth of the drug's worldwide sales. Merck had to meet Pinheiro's price for indinavir, the generic. But the company can do this and still profit. ''The half-million infected today are patients of tomorrow,'' Tadeu Alves told me. The same thing may soon happen with Merck's Stocrin, which is patented in Brazil. Pinheiro is threatening to get a compulsory license to make the generic. The threat will most likely force Merck to drop the price or voluntarily license Pinheiro to make the generic or sell Stocrin. And this arrangement will be profitable for Merck, which shows no sign of shutting its labs because of Brazil. Yet the pharmaceutical industry continues to paint the ongoing battle against generics in impoverished nations as Armageddon. Glaxo has even stopped the Indian generic manufacturer Cipla from selling a knockoff of a Glaxo AIDS drug in Ghana. Ghana's share of the international antiretroviral market is virtually zero. If wealthy countries and the united nations agencies they influence chose to make AIDS treatment available to every citizen of the earth in the most efficient and cost-effective manner possible, the program would look very much like Unicef's global system of vaccination. When Unicef began a campaign to vaccinate the world's children in the early 1980's, many scoffed. But today vaccination rates top 80 percent, saving three million lives a year and preventing crippling diseases in tens of millions more. This is one of the world's most significant public health victories. Who pays to vaccinate a child in Angola? We do, without much complaint. Antiretrovirals, of course, do not cost pennies per dose. But they would be a lot cheaper than they are today if the World Health Organization or Unaids used a Unicef-like system, which has dropped the price of vaccines to a thirtieth of their American price in some cases. The W.H.O. could buy antiretrovirals for third-world use from reliable generic suppliers like Cipla in India or brand- name manufacturers if they were willing to lower their prices. The economies of scale and guaranteed markets could drop the price of a year's triple therapy to below the $700 that Cipla could muster today. This is a price many countries could afford, especially when balanced against the savings in hospitalizations. But everyone agrees that AIDS treatment will require North America and Europe to purchase the medicines and to help set up the necessary health care network. In my calculus, applying the Unicef system to AIDS would cost $3 billion a year in antiretrovirals alone, assuming five million patients at $600 a year. And the cost will increase as countries reach more patients. This is a large sum of money. It seems somewhat smaller, however, next to the wards of shaven-head babies - or the collapse of a continent. It is difficult to imagine the Bush administration endorsing such a global plan. There are, however, smaller, worthwhile steps the administration could take if it were so inclined. At minimum, it should bury forever the bad old policy of intimidating countries that want to make or buy generics, especially through compulsory licensing. The administration should also encourage agencies like the World Health Organization and Unaids to facilitate these purchases and the necessary training to make them work. There are also laws already on the books, which the Clinton administration chose not to carry out, that could promote the cheap production of at least some antiretrovirals. One such law allows the government to seize patents of drugs that were discovered at government labs or with substantial public funds if the patent holder is not meeting public health needs - for example, by charging too much. James Love, who runs the Consumer Project on Technology, a Ralph Nader- affiliated advocacy group, argues that it applies to five antiretrovirals. Love would like to see the government license them to a nonprofit corporation that would produce the drugs cheaply for both the first- and third-world markets. But the Bush administration is unlikely to be so inclined, because the drug companies have other ideas. ''Merck and other companies appreciate that our products need to be more affordable in the developing world,'' Jeffrey Sturchio, a Merck spokesman, told me, echoing every pharmaceutical maker. ''We are willing to sit down and be a constructive partner. Compulsory licensing is unnecessary.'' But compulsory licensing seems very necessary. Merck would have little interest in constructive partnership in Brazil - or anywhere - if that threat did not exist. This is the larger lesson of Brazil: AIDS can become a manageable disease in the third world, but it takes power, in addition to other things. The ability to pull the price of AIDS drugs within reach of those who need them may someday come from the backing of some international organization, or the pharmaceutical industry might find religion. But at the moment, it arises only from the threat to make or buy generic drugs. AIDS is turning the third world's human landscape into a parched wasteland. Brazil has shown that, armed with the power of competition, a government can do more than sit and watch the desert encroach. WOZA, South Africa, 15 January, 2001 Pharmaceutical companies to sue over generic AIDS drugs, by Marjolein Harvey, A group of more than 40 drug companies will take government to court to prevent the importation and manufacture of generic AIDS drugs, the Citizen newspaper reported on Monday. It follows a controversial campaign by HIV/AIDS activists Treatment Action Campaign (TAC) which has illegally imported cheaper generic drugs. The SA Pharmaceutical Manufacturers Association would launch the action on behalf of its members, the paper said. The health ministry said government would oppose the application which will be heard in the Pretoria High Court on March 5. In October last year, the TAC landed itself in legal trouble when it announced that it had imported 5 000 Biozole capsules from Thailand, a generic of Pfizer's Fluconazole, at far below the latter's price. Their action defied Pfizer's patent on Fluconazole and was condemned by Medicines Control Council head Helen Rees for being illegal. Rees laid a criminal charge against the TAC, and the TAC handed its entire consignment over to the police. The action by the TAC received widespread support from the SA coalition of non- governmental organisations, as well as trade unions. "There is tremendous pressure from the pharmaceutical industry, whose sales worldwide are double that of our economy," said TAC chair Zackie Achmat, himself HIV-positive, but refusing HIV/AIDS medicines on the grounds that their price inhibits their access to the majority of South Africans. "We want to help our government to get the drugs to the people." The TAC arranged a bioequivalent study to ensure the imported medicines were of the best quality. The World Health Organisation inspected the factory in Thailand where the drugs were manufactured and Medecines sans Frontieres in Thailand brought out an international pharmacist to inspect the plant. The MCC subsequently granted a section 21 exemption for the drug. TAC has begun to establish a network of doctors and pharmacists who would prescribe high quality, low cost generic medicines imported from countries such as Thailand and Brazil. Fluconazole is used to treat cryptococcal meningitis and thrush in the vagina and throat, diseases susceptible to people living with HIV/AIDS. According to the TAC, the drug company Pfizer sells Fluconazole for R80.24 per capsule to the private sector and R28.57 per capsule to the public sector, while the Thai equivalent costs R1.78. The move was part of the body's defiance campaign against 'patent abuse and AIDS profiteering' by multinational pharmaceutical companies. Government has been involved in a trade dispute with the US and several European countries over its efforts to make medicines less expensive. The most important disputes involved South Africa's Medicines Act, and in particular, a new Section 15c of the Act that would provide authority for fast track compulsory licensing of medicines and authorise parallel imports of medicines. On December 1, 1999, the US government finally dropped South Africa from its "301 Watch List," a sign of US government change in policy. The policy change was a response to US domestic protests. This isn't the end of the dispute, however, because the US continues to monitor South Africa policy, and 42 pharmaceutical companies have sued in the South African courts to prevent the Medicines Act from becoming law. Contrary to many news reports, the private lawsuit has remained active. On August 1 last year, the PMA resumed litigation against the Medicines and Related Substances Control Act No 90 of 1997, arguing that it still undermines patent protection for pharmaceuticals. The TAC argues that the companies "put profits before people". According to the World Health Organisation (WHO), drug companies spend nearly R400 billion on health research; but only 10% of that figure is spent on diseases that affect 90% of the global population. ************ (Copied for fair use. This is an interesting article, but please note that the legal opinions expressed in it are probably not accurate.) The Nation (Nairobi) January 22, 2001 Paul Redfern, Nation Correspondent London A critical test case in South Africa in less than two months could decide whether or not African countries will in future be able to import cheap generic drugs to treat their Aids afflicted populations. On March 5, the might of the world's major pharmaceutical giants are set to take the South African government to court over a law passed by previous President Nelson Mandela giving his country the right to buy huge amounts of generic drugs and sell them cheaply in South Africa. The law also allows South Africa to compulsorily licence HIV drugs and manufacture them within the Republic, undercutting the multinational drug companies The issue is critical for Africa because generic drugs, which are usually made in East or South Asia are often a fraction of the cost of the drugs produced by the western pharmaceuticals. The pharmaceuticals say that importing such drugs breaks agreed rules on intellectual property rights and they want the law overturned. While it is acknowledged that only around one per cent of drug revenues to the multinationals come from the entire African continent, the pharmaceuticals believe the issue is a threat to their interests. They claim that money lost through cheap generic drugs could be ploughed into more research and development which may ultimately lead to a cure for HIV. The companies also argue that farming out cheap pills to countries that don't have robust infrastructures will not work. They say that such drugs have to be monitored with scans and therapies and if that is not done the drugs are useless. But what campaigners believe the western drugs companies are most afraid of is that the case will alert the public as to the true low cost of many anti- retroviral drugs, leading cash-strapped western health authorities to themselves look to the cheap generic alternative. The campaigners also point out that most pharmaceutical companies have already made substantial amounts of money from the anti-HIV drugs and that these should no longer have a patent. "The big drugs firms are scared that if they turn a blind eye to the wholesale production of cheap, generic drugs in South Africa it will set a dangerous precedent which will be difficult to prevent spreading," an Observer story said In Kenya, the case is likely to be watched with interest by the government which is at present being forced into accepting World Trade Organisation rules which allow for a 25 year patent on such drugs. At present only a staggering 0.001 per cent of the 25 million people infected with HIV in Africa receive anti-retroviral drugs which are now known to significantly prolong the lives of people with HIV and are usually freely available in the West. To head-off growing concern within Africa and a building anti- pharmaceutical campaign in the West, drugs companies have responded to accusations that they are acting inhumanely in putting profits before the health of a whole region by beginning talks to reduce the price of their drugs, providing that countries agree to health action plans which have been drawn up. Already Uganda and Senegal have come to an agreement on the issue and others are set to follow suit. GlaxoSmithKline, the UK company, has gone further in offering to supply HIV treatments at 80 per cent discounts of prices in the West, if developing countries were to have the correct health infrastructures in place. But the Observer newspaper points out that previous high profile offers of cheap Aids treatment from the Clinton administration came with strings attached. It noted that a $ 1 billion offer of cheap drugs from the US last year turned out to be export-import loans at commercial interest rates to buy US drugs at market prices. The offer was turned down. Western governments are fighting shy of taking on the multi- nationals on the issue arguing that the right approach is for poor countries to negotiate discounts with the pharmaceuticals. But campaigners point out that African countries can't even afford the discounted prices offered. In November, the chairman of Kenya's Aids control council, Dr Mohammed Abdullah said that the proposals set out last summer by the world's leading pharmaceutical companies to slash the cost of Aids drugs was "cynical and hypocritical" because it would only bring prices down to Europeans levels meaning that the vast majority of Kenyans still could not pay for the anti- retroviral drugs. Western campaigners are increasingly highlighting the problem as the new issue of the 21st century arguing that developing countries must be able to use all possible means to get hold of affordable drugs to stop their people dying. "Imaging witnessing devastating plague and sitting on a cure for fear of incurring shareholder revolt," said Ben Jackson of the UK-based development group 'Action for Southern Africa.' "That essentially is the position of drugs companies. Sure healthcare infrastructures have to be put in place but it is not an either-or argument. These things can be done simultaneously." The Observer newspaper however notes that if the South African government loses the case it could face costs running into tens of millions of dollars. *** (Copied for fair use) Oxfam Campaigner - Issue 38 - Dec 2000 Sick people, healthy profits The WTO's patent rules mean that millions of people cannot afford the medicines they need. Natasha Hickman investigates In December 1999, demonstrations on the streets of Seattle brought the Third Ministerial Conference of the World Trade Organisation (WTO) to a premature close and focused international attention on the body responsible for making the rules that govern global trade. A year on, away from the spotlight, it's business as usual for the WTO. And the WTO is in the business of making rules that promote commercial interests, even if they widen the gap between rich and poor nations, and threaten the livelihoods and health of poor people. Nowhere is this imbalance more graphically illustrated than in the WTO agreement on intellectual property rights, which threatens to deprive millions of people of access to life-saving medicines. More than 27 million adults and children die each year from preventable infectious diseases. Almost all live in the developing world. Many more lives could be under threat from the emergence of drug-resistant strains of diseases such as TB and malaria - which already account for three million deaths. And as the HIV/AIDS epidemic sweeping sub-Saharan Africa shows, devastating new illnesses can appear at any time. With such startling statistics you might imagine that research into tropical diseases would be a priority for governments and pharmaceutical companies. Unfortunately for people in developing countries, this is not the case. So what's the WTO's role in this? The WTO - thanks to intensive lobbying from the pharmaceutical industry - was responsible for introducing restrictive intellectual property laws, known as the Agreement on Trade Related Aspects of Intellectual Property, or TRIPs. The TRIPs Agreement grants large pharmaceutical companies worldwide 20-year patent protection on their new drugs. This means that companies will be able to keep their prices artificially high, because countries can be prevented from developing cheaper, non-brand equivalents. The difference in price between patented drugs and their non-brand ('generic') alternatives is phenomenal. Take Fluconazole, the treatment for HIV/AIDS-related meningitis. In Kenya, where only the named brand is available, a sick person would need to find US$20 a day to pay for a course of treatment. In Thailand, where a locally produced generic drug is available, the price drops astoundingly to just US$0.70. If the TRIPs agreement comes into force, countries that belong to the WTO will risk stiff trade sanctions if they manufacture or import these cheap generic drugs for their own citizens. In effect, vital drugs designed to treat new diseases, and old killers such as malaria, will be priced beyond the means of poor people. The WTO isn't without a conscience, however. The patent rules do contain provisions that permit a government to grant licences for generic drug production on a case-by-case basis - for example, if there is a health emergency within their country. However, the safeguard is meaningless for many developing countries, because they do not have the industrial and scientific capacity to produce such medicines. The few that do have the ability are restricted from exporting to the rest. Expensive drugs could result in millions of poor people being denied life-saving treatments. Oxfam believes that governments need to take a long, hard look at the public-health impact of global patent rules. Reforms to TRIPs should allow poor countries more freedom to decide their own patenting systems, according to the health needs of their people. This could include choosing to exempt priority medicines from patenting (as many rich countries did until recently). Pharmaceutical companies argue that without patents they would have no budgets to invest in research and development of new drugs. Oxfam accepts that patents can stimulate innovation, but believes that restricting their scope in poorer countries would not have a significant impact on research. Developing-country sales are a tiny part of company turnover, and in fact, government and non- profit organisations contribute a great deal to the costs of research. Life-saving drugs must be made affordable to people in poor countries in the midst of such health crises. Oxfam is particularly concerned that any new treatments that may appear will be priced out of the reach of poor people by global patenting rules. Millions of people could die in Africa because the medicines they need are too expensive. At Oxfam we are not prepared to sit back and watch this happen. And we're not alone. There is a growing international coalition of NGOs, health organisations, trade unions, and Southern governments which are seeking changes to the rules. Early next year, Oxfam's Trade Campaign will step up a gear, building on our successful campaigning on Fair Trade and ethical trade issues, and sustained pressure for fundamental reform of the WTO. Changes to the TRIPs Agreement are just one aspect of this campaign to make sure that world trade rules benefit poor people and give them a chance to help themselves. As ever, your support will be vital in Oxfam's fight to show governments, companies, and the WTO that we mean business. In the next issue of Oxfam Campaigner we will explain in detail how you can get involved. Watch this space. **** (Copied for fair use) The Globe and Mail, Friday, January 26, 2001 J'accuse! The West is willfully turning its back on the greatest human tragedy of our age, says the former deputy head of Unicef By Stephen Lewis Last October, I sat in on a Grade 5 "life skills" class at the David Livingstone Elementary School in Harare, Zimbabwe. There were 41 of the most eager, verbal, bright, downright adorable 10-year-olds I had seen in a very long time. Life skills classes, held once a week, give teachers the opportunity to deal with the HIV/AIDS pandemic raging through the country, indicative, as it is, of what's happening throughout Southern Africa. "I want to know what you worry about," said the teacher. "I want each of you to write down your greatest worry on a piece of paper, and then I'll gather them all up, put them in this box, and draw them out one by one to talk about what you've said." I'm not going to go into the details of each fascinating, lively and intense discussion that accompanied every hand-written note. I'm simply going to observe that in seven of every 10 instances, the words on the paper had something to do with death. Death of a parent, death of a sibling, death of an uncle or aunt, death of a friend's father, death of a friend. When the teacher asked the kids what they would do about this pervasive chant of death, they answered, in the majority, "prayer." When the teacher pressed them to be more specific, they said "We'd call on God." As we left the classroom, I awkwardly told the teacher that I didn't really understand the responses. And she said that I was right: I didn't understand. "You see, Mr. Lewis, when everyone is dying all around you, the children don't know what to do but pray. We pray after school, we pray at lunch-breaks, we pray on Saturdays, we pray all the time. For the children, since nothing else seems to work, the intervention of God is the only hope left." That afternoon, I toured the adult wards of the Harare General Hospital. It is no hyperbole to say that virtually every bed was filled with the dead and the dying. There were almost no drugs to treat the most painful opportunistic infections, let alone drugs to treat the virus itself. And right in the midst of our walkabout, orderlies would wheel in grisly aluminum caskets to cart away those who had just died. There were moments when I felt I was standing in a graveyard. Let me fastforward, as they say, to last Friday. I was in New York to sit in on a Security Council debate dealing with HIV/AIDS and peacekeeping forces. The day was oddly discordant, because in the midst of so serious a subject, it was also the last hurrah of the outgoing American Ambassador, Richard Holbrooke, and the air was filled with mocking jibes, grovelling farewells and other clubby rhetorical appurtenances. Nonetheless, two speeches broke the pattern of forced camaraderie and stale interventions. The French Ambassador unleashed a verbal broadside against the pharmaceutical companies, and their hideous refusal to provide drugs at cost or, even better, no cost at all. The Indian Ambassador abandoned all the customary proprieties to make the point that millions of people in the South were dying while the North refused to provide the dollars, or to amend intellectual property rights so that drugs would be available and death forestalled. As I sift these disparate episodes through my mind, one question keeps intruding: I want someone to explain to me why it isn't called murder. Last year there were 3.8 million new infections in sub-Saharan Africa. Last year 2.4 million people died of AIDS in sub-Saharan Africa. By the end of last year, 25.3 million Africans were living with the disease, 55 per cent of whom are women. The most vulnerable target group lies between the ages of 15 and 24. More than 16 million Africans have died since the pandemic began in the late 1970s/early 1980s. A significant change has recently occurred in the way the disease is viewed in Africa. Up until the middle of the year 2000, the focus was overwhelmingly on prevention and care. Then, abruptly, at the international conference on AIDS in Durban in July, and again at the African Development Forum in Addis Ababa last December, the ground shifted. Suddenly, "People Living With Aids" began to make their voices heard, and their voices cried out for treatment. It brings back another recollection. I remember chatting with three pregnant HIV-positive women at a little prenatal counselling clinic in Kigali, Rwanda, in the summer of 1999. They had all voluntarily accepted testing, and they were all voluntarily on drugs to reduce mother-to-child transmission, and they were all thinking about whether or not to breast-feed their babies, because breast-feeding increases the risk of transmission, although bottle-feeding is obviously very difficult to afford and to arrange in Africa. After we discussed, almost triumphantly, the choices they now felt open to them, the conversation took a dramatic turn. I'll never forget it: "Okay," they said, "we'll do anything to save our babies, but what about us?" I had no answer. And that's the crux of the issue. Here in the wealthy West, we have antiretroviral drug cocktails which prolong life, improve the quality of life, and serve, as it were, to save life. We have the drugs. We use them. In the developing world, where 95 per cent of the new infections occur, virtually everyone HIV-positive is doomed to a gruesome and painful death. The numbers of people who can afford the drug cocktails are so infinitesimal as be invisible. But it's worse, much worse. Neither the pharmaceutical companies who have the drugs, nor the governments who have the money, nor the governments who could amend their laws to make cheap generic drugs available, are prepared to prolong or to rescue African lives. Some six months ago, there was an international flurry of self-congratulation as five multinational pharmaceutical companies promised to reduce or remove the cost of HIV/AIDS drugs for Africa. Intense private negotiations between the United Nations and the companies have followed. The negotiations are a farce; they redefine the meaning of bad faith. Nothing of consequence has been agreed. It's really the monumental scandal of our times. Admittedly, it would be no easy matter to monitor and treat large populations of infected people through health delivery systems that are often in tatters. But you could still reach a significant number. The fact that we're not even prepared to try is a miserable commentary on the human condition. Let me put it as simply and bluntly as possible. The drugs exist and the money is available to prolong and improve the lives of millions. Some would live a full life-span. Jeffrey Sachs, the noted Harvard economist, says that there are generic drugs which could be imported from India to treat the majority of HIV-positive Africans for $350 per person per year. If we had the political will, there is no question that we have the money. Then why isn't it being done? And because it's not being done, why doesn't it amount to murder? Mass murder. Stephen Lewis is a former Canadian ambassador to the UN. He has served as deputy executive director of Unicef, and as a member of the International Panel of Eminent Persons, which was set up by the UN to review the 1994 genocide in Rwanda. ****** From Health-e (copied for fair use): Generic company wins right to produce antibiotic By Sue Valentine 19-01-2001 South African generic medicine producer, Triomed, has emerged victorious in a legal battle with pharmaceutical giant SmithKline Beecham over the right to produce a generic version of a special penicillin-based antibiotic. SmithKline Beecham, producers of the drug Augmentin, accused Triomed of trademark infringement, following the launch of its generic counterpart AugMaxcil. It objected to Triomed's name for the tablet and the fact that Triomed retained the shape of the original tablet. The SmithKline Beecham patent on Augmentin expired in 1996. In a recent judgment, the Pretoria High Court found that Smithkline Beecham (SKB) had no right to claim patent rights over the shape and name of the tablet. It did find, however, that Triomed had infringed copyright in reproducing parts of the package insert and granted an interdict to SKB in this matter. In his judgment, Judge Smit said that the trademark, which depicts an elliptical, bi-convex tablet with a band, was too vague for the purposes of a valid trademark registration. He added that SmithKline Beecham appeared to be trying to obtain a monopoly over the shape as well as any similar shape and that this would limit the development of the pharmaceutical industry and would stifle competition. Judge Smit said the shape of the tablet could not be claimed as a trademark of the original. Triomed general manager Gary Holloway said the case was a victory against "the monopolistic bullying tactics of the big drug companies to protect their high profits". It was also a victory for the rights of consumers to access cheaper generic alternatives. The cost of the generic, AugMaxcil is approximately a quarter of the price of the original, Augmentin. "By attempting to register different trademarks, including the shape of the tablet, Smithkline Beecham was trying to control access to the drug beyond its patent life," said Holloway. However, the attorney for SKB, Brian Wimpey, said the matter had nothing to do with the quest for affordable healthcare. He said the issue was one of trademark infringement and validity. "SmithKline Beecham has no objection to the launch of a generic substitute to its successful Augmentin product – it objected to Triomed launching a product identical in shape, colour and size to its own and utilising a similar name," said Wimpey. He added that SKB had appealed the judgment. The decision in favour of Triomed, the third largest generic company in South Africa, comes in the context of several other challenges to the patent rights of big pharmaceutical companies. In recent months, the Treatment Action Campaign (TAC) has imported two consignments of the Thai-produced drug, Biozole, the generic version of Fluconazole to which Pfizer holds the patent in South Africa. The TAC has complied with all the requirements laid down by the Medicines Control Council to gain a Section 21 exemption to allow for the use of Biozole as an approved generic. Fluconazole is an effective antidote to cryptococcal meningitis and thrush – two opportunistic infections that often affect people with HIV/AIDS. If these infections are treated, people with HIV/AIDS are able to lead healthy, active lives. Dr Steve Andrews of the Brooklyn Medical Centre in Cape Town, the private medical practice which will import the generic in contravention of Pfizer's patent, says he is doing it because he is tired of watching patients die because they don't have access to affordable drugs. "Dying of starvation and dehydration because you can't swallow [because of thrush] in the presence of drugs that can stop that is approaching the level of crimes against humanity," says Andrews. More than three years ago, an attempt by the previous Minister of Health, Dr Nkosazana Zuma, to pass legislation to ensure access to affordable medicines drew sharp reaction from the Pharmaceutical Manufacturers' Association (PMA). It instituted legal proceedings against Section 15c of the Medicines and Related Substances Control Act No 90 of 1997 because, it said, the new law did not respect patent rights. Yesterday, the PMA announced it would resume its litigation to block the manufacture and importation of generic drugs as provided for in Section 15c of the Medicines and Related Substances Control Act. The case is due to be heard in the Pretoria High Court in March. Developing countries such as Brazil, India and Thailand each have strong generic production capacity – some are private companies and others are state-owned. In Brazil, the production of affordable generic anti-AIDS drugs has had a significant impact in improving the quality of life of people with HIV/AIDS. – Health-e News Service ****** KEYCODE BAYER is published by the German group BAYERwatch which has been monitoring the BAYER Corporation for more than 20 years. ========================================== From Bayerwatch (copied for fair use): UK: Bayer in Illegal Drug Trial Scandal Over 300 unsuspecting patients in hospitals across the UK were subjected to experiments of a new application of the Bayer drug Ciproxin with which the company wanted to enter the highly lucrative UK antibiotics market. A senior hospital consultant in Southampton, Steven Karran, who had carried out extensive studies of the effects of Ciproxin on patients undergoing large bowel surgery, warned Bayer clearly of the dangers of this drug. Bayer ignored these warnings for over two years. "The Bayer ciproxin trial in Southampton, of which I have first-hand knowledge, was scientifically, clinically and financially fraudulent. It exposed patients to serious risk of infection and violated their basic human rights", Karran says. Karran´s warnings were backed up at the time by another member of the Southampton Hospitals Trust´s Ethics Committee, John Whale. After five years Bayer is still keeping the trial results secret and obviously fears prosecution. Normally drug trial results are published within a few months. Recently an MP demanded a clear statement from Bayer about the unapproved trial. A senior research scientist at the company´s headquarters in Newbury, Dr. James Parker, tried to fob off the enquiry by telling the MP she was "misinformed" that patients were offered full protection when Bayer asked for their consent for the experimental use of the drug. This, even though the patient information sheet stated clearly, "you are well protected against any post-operative infections". Bayer gave false information to the Medicines Control Agency when applying for a certificate to try out the new application of its drug. Bayer already knew through research it had sponsored at Southmead Hospital in Bristol that Ciproxin would be ineffective in preventing infections because of dangerously diminished absorption and interaction with premedicants. The surgeon Steve Karran who acted as whistleblower has lodged an affidavit stating that he warned the responsible managers at both the company´s headquarters in England and Germany and the Hospitals Trust of the serious dangers to patients. Instead of stopping the trial the Southampton Hospitals Trust hounded him out of his post for misconduct and it was only after Karran appealed to the GMC that he was reinstated. A senior consultant, John Primrose, who was an accessory to Bayer´s illegal experiments and currently under investigation by the CID on manslaughter charges continues to practise. Bayer has not been prosecuted, has paid no compensation to relatives of patients injured or killed in the course of its unapproved trials and is still keeping the results under lock and key. Reports on aspects of this serious malpractice by Bayer and a number of consultants in Southampton, Glasgow and other hospitals throughout the UK appeared in the Mail on Sunday (Martyn Halle) and Sunday Times (David Leppard, Insight Editor). INTERVIEW WITH DR STEPHEN KARRAN How and when did the problems with the Bayer antibiotic ciproxin become evident? In 1993 Bayer submitted the trial protocol for approval by the Southampton Hospital Trust Ethics Committee. At that time I was Reader in Surgery at the University of Southampton and member of the Ethics Committee. Professor John Primrose had "brought" the Bayer study with him from Leeds and wished it to be extended to patients in Southampton. I had serious doubts as to the scientific and clinical validity of the Bayer ciproxin trial. In a previous protocol submitted by Bayer in June 1992 there had been problems with ciproxin because of diminished absorption. For marketing reasons Bayer was keen for the drug to be given orally to the patients in the U.K. trial (Note: when given prior to an operation in Germany, ciproxin is always given intravenously to patients undergoing large bowel surgery – in other words, Bayer was willing to put British patients at risk by using the drug in a way which would be illegal in Germany.) Three groups of drug commonly given to patients before major surgery interfered with the absorption of the Bayer drug ciproxin. Secondly, the comparator suggested by Bayer was a standard drug for the proposed application but used in a sub-optimal dose. The comparator proposed by Bayer was cefuroxime. The using timing is three doses in a twenty-four hour period. Bayer gave only one dose over twenty-four hours and referred to results obtained from a Glaxo study with Clafuran (Roussel). However, Bayer`s quoting this study in this connection was fraudulent because this was a different drug. Another problem emerged two years later. An investigator enquired whether patients would be concurrently taking part in any other study (anticancer drugs and radiotherapy simultaneously). Bayer informed the investigator that this would be acceptable. This was clinically fraudulent according to General Medical Council (GMC- doctors`and surgeons regulatory body) and would not have been passed by the Ethics Committee. As is customary in such drug trials, Bayer promised patients taking part full protection against post-operative wound infection but they were in fact exposed to a real risk of developing infections i.e. their basic human rights were violated in that they were given unapproved drugs and were also deliberately deceived by Bayer into giving consent to the trial under false pretences. Medical staff who queried giving ciproxin in this way to patients undergoing colorectal surgery were assured by Bayer that the drug and procedures used had been approved by the Ethics Committees and the Medicines Control Agency. This is untrue. I have seen the trial results for the seventy patients who took part in the Bayer trial in hospitals under the Southampton Hospitals Trust and they show clearly that nearly half of the patients developed post-operative wound infections requiring "rescue therapy" i.e. emergency therapy. Bayer`s actions represent a major criminal assault on the patients who took part in the ciproxin trial. When did it become clear that there were problems with ciproxin? The problems arose through the nature and design of the Bayer trial rather than the drug itself. Bayer was aware of the absorption and interaction problems two years before the ciproxin study was designed through studies carried out by Professor Reeves in Bristol. Bayer sponsored the work at Southmead Hospital to acquire data. When the company discovered that the results of the preliminary studies ("assay work") were likely to have a negative effect on sales of ciproxin, it simply decided to suppress and ignore the results. In what ways do you think Bayer is at fault? Bayer has acted fraudulently in several ways: firstly in terms of the scientific validity of the trial design – the study was scientifically flawed from the outset; secondly clinically in terms of their treatment of the patients taking part, who were deceived by Bayer into giving consent and furthermore had no proper protection against post-operative wound infections; thirdly in my view the company has acted unethically in spending vast sums of money – well over half a million pounds – in attempting to "bribe" members of the medical profession to act unethically, that is, Bayer has compromised a large number of professionals by assuring doctors that its methods and procedures were ethical when infact it was well aware that this was not the case. Do you have any comments on Bayer`s press release of 26th May 2000? The statements made by Bayer concerning the ciproxin trial are evasive, untruthful and deliberately misleading. Are there any up-to-date independent reports on the use of ciproxin against post-operative wound infection in large bowel surgery? There is no other research to date which might indicate that this is a false alarm. Bayer should have untertaken further research if it was not satisfied with the outcome of ist original studies. In the absence of such further studies the research results originally obtained must be regarded as valid. In June 1992 Bayer knew of the problems of diminished absorption and interaction with common pre-medicants of the Bayer antibiotic ciproxin when administered by mouth but did nothing for a least two years to protect the lives and well-being of patients. It was not until June 1994 that Bayer admitted the existence of an absorption problem and rewrote the ciproxin trial protocol accordingly. Since that time ciproxin has not been administered orally to patients in British hospitals for the prevention of post-operative wound infections after large bowel surgery. Are all the trial results freely accessible? No. Bayer has refused to disclose the results on spurious grounds of confidentiality. Consultants and doctors who participated as investigators are also keeping quiet. What are the problems connected with the Bayer ciproxin trials in Southampton? The Bayer ciproxin trial in Southampton, of which I have first-hand knowledge, was scientifically, clinically and financially fraudulent. I compromised the integrity of the University, the NHS Hospitals Trust and the individual doctors involved. It exposed patients to serious risk of infection and violated their basic human rights: real physical harm was done to patients who were deceived by Bayer and ist representatives into believing that they would be fully protected against post-operative wound infections throughout the duration of the study. (See patient information sheet) The Bayer company and the consultants and doctors who took part in the ciproxin study have entered into a conspiracy to draw a veil of silence over the whole matter. In my view Bayer`s behaviour and that of certain consultants who knowingly deceived patients, exposing them to potentially fatal infections warrant to pressing of criminal charges. One consultant who was Head of Surgery at the relevant time in one of the Southampton hospitals is now being investigated by the CID on a manslaughter charge. Were the hospitals taking part in the ciproxin trials warned of possible risks to patients involved? Yes, in October 1993, by me. To the best of my knowledge, I was the only person to draw attention to the serious dangers posed by the oral administration of the Bayer drug ciproxin to patients undergoing colorectal surgery. I know that the Glasgow investigator was aware of the dangers to patients from post-operative wound infections but both he and the consultant Head of Surgery at Southampton, Dr. John Primrose, chose to remain silent about the risks involved. There was also an investigator at the Dutch centre involved in the ciproxin trial, a hospital in Rotterdam, who knew of the risks but also chose to remain silent. Did Bayer take yours objections to ciproxin and the timing and method of its use seriously? Not at the time. Later they admitted that there was a grave problem and SIX MONTHS LATER they rewrote the trial protocol BUT this was only because I had lodged an official complaint – they did not act of their own volition. They took action to change the protocol in June 1994 but the amendment did not appear in the protocol until December 1994. At this point the Bayer ciproxin drug trial had been running for over TWO YEARS: How did the Health Service Trust react on being warned of likely problems and hazards for the lives and well-being of patients in their care? The Southampton Hospitals Trust initially refused to investigate. In January 1996 I made a formal request to the Health Sevice Trust to enquire into the activities of the Bayer company and the medical staff involved in the ciproxin drug trial. The Trust refused to take action but initiated disciplinary action against me in January 1996 at the request of the Head of Surgery, Professor John Primrose, for reporting the matter. It was in fact only through a chance conversation with the investigator`s research nurse that I had learned that Bayer and John Primrose were proceeding with the ciproxin trial in Southampton on the basis of the original unamended (and therefore faulty) protocol which Bayer wished to retain to optimize the sales chances of the drug ciproxin. I should note that the grave medical malpractice perpetrated by Bayer and certain consultants in Southampton was corroborated at the time by a former policeman and fellow member of the Ethics Committee, John Whale. (See report by Martyn Halle, "Mail on Sunday" 8.8.99 "..70 patients at risk" and David Leppard "Sunday Times" "Bayer company put patients at risk in hospital trials"). Are the serious problems which have arisen in the case of the Bayer ciproxin trial typical for hospital drug trials by pharmaceutical companies in general or has Bayer behaved differently from competitors? In the eight-year period I sat on the Southampton Hospitals Trust Ethics Committee we dealt with over 200 applications, adding up to a total of over one-thousand six-hundred drug trial applications: I have never experienced anything remotely similar to the Bayer case with the antibiotic ciproxin. If a protocol or drug is faulty the investigators and the company involved are refused permission to go ahead and accept the decision of the Ethics Committee: Bayer and the investigators involved in the ciproxin trial ignored the decision of the Ethics Committee and went ahead with an unapproved drug used in an illegal manner. ***********