The Right Prescription

Like the United States and the world's richer nations
Brazil—with much cunning, lots of daring, plenty of work
and little money—has transformed AIDS from a lethal scourge
into something much more manageable and pronounceable:
a chronic disease. The whole world, mainly
the developing countries want to learn how can
they do the same for their own AIDS victims.

Francesco Neves

As has often been the case, not until renowned French daily Le Monde and Yankee publications like The Washington Post, The Wall Street Journal, Time magazine and The New York Times had talked about the subject, did the main Brazilian press open space to report that Brazil has become a model and an inspiration for nations around the world on how to fight and win the war against AIDS. Not a small feat for a country that often appears very low on international lists of health care providers and high on rosters of violent and corrupt nations.

Brazilians felt good that for once it could make news as example for other countries to follow. Thanks to a free government program of AIDS medicine distribution the nation won some headlines on the positive column although multinational laboratories and the US tried to paint the country as an outlaw infringing on patent and stealing intellectual property. International organizations like the United Nations and Nobel Prize Winner France-based Médecins Sans Frontières (Doctors Without Frontiers), however, had only words of praise for the pioneer work of Brazil. The Médecins group praised "the political commitment of the Brazilian government, which cut in half the number of deaths caused by AIDS from 1996 to 1999."

While rich countries have been able to keep AIDS victims alive and leading a productive life, the same didn't happen to the rest of the world that cannot afford the expensive antiretroviral treatment, which can cost as much as $15,000 a year in the United States. That's why the disease is ravaging Africa, India and has become a serious health problem for Eastern Europe. Brazil should also be in very bad shape according to estimates from the early '90s.

In 1994 the World Bank predicted that Brazil would have 1.2 million AIDS victims by the end of the year 2000. And they seemed right. During the '80s, the number of new cases of AIDS was growing by 35 percent a year in the country. Brazil, however, surprised the World Bank and itself. The country today has 530,000 cases of the disease—less than half of what the Bank predicted—and the epidemic has stabilized with 20,000 new cases a year for the last three years. It's believed that four-fifths of those infected with the disease in Brazil don't even know they have AIDS. Many of the 95,000 people infected with AIDS and receiving treatment are being seen as outpatients and are living an almost normal life. The program should be extended to 110,000 patients by year's end.

Now, while 20 percent of adults in South Africa and many African nations are infected with HIV, the rate of Brazilians with AIDS is 0.6 percent. Throughout the country, special places created to attend to HIV-positive people, like Casa da AIDS (AIDS Home), in Santos, São Paulo, use beds reserved for AIDS victims to care for other diseases, since those with AIDS come only once in a while to pick up their medicine and take it home. Brazil's public health policy has lowered the AIDS infection rate among adults to 0.6 percent. Compare this to Botswana where this rate—the world's highest—is 35.8 percent.

Since 1997, virtually every Brazilian who needs the saving cocktail, the same drug mixture that keeps AIDS victims alive and productive in the US and Europe, can get it for free from a government administered clinic. Even in the US, AIDS victims from some states who cannot afford the expensive antiretroviral medication might die without having access to it.

In the last four years, the number of deaths caused by AIDS has dropped 50 percent at the same time that the number of people being admitted to the hospital due to complications of AIDS fell 80 percent. As Paulo Teixeira, the Health Ministry's coordinator for the AIDS fighting program recently told Brazilian reporters: "The disease's expansion has been contained."

For Luiz Loures, UNAIDS' s chief for Latin America and the Caribbean, Brazil's pioneering has been a worldwide inspiration: "The Brazilian response is kind of a flagship not only in Latin America and the Caribbean but also at the global level," he said, adding, "The Brazilian response is transferable. While Brazil is wealthier than some other developing nations, political will and community support have made the difference in a variety of countries. We are also looking at other countries, such as Senegal and Uganda, that have taken the lead in Africa or other regions to provide symbols in this fight."

The harder battle, the one that demanded the most effort—a discipline other countries didn't believe Brazil would be able to demonstrate—was that from patient to patient. The effort from an Army of officials, doctors, helpers and volunteers—approximately 600 NGOs (Non-Governmental Organizations) have joined forces—that united in a common work to distribute the saving medicine and guarantee it is taken correctly, at the right times, some with food, some without.

Daily O Estado de S. Paulo reported on a telling story that illustrates how AIDS was cornered and controlled in the country. In 1991, when doctor Robinson Fernandes de Camargo started to treat HIV positive people in Sapopemba, in the east side of São Paulo, people in the average were surviving two years, and his main effort was to guarantee that the infected person had a dignified death since there was no prospect of prolonging his or her life. Ten years later, at the Centro de Referência Herbert de Souza "Betinho" AIDS continues to kill—there were six AIDS related deaths in 2000—but the situation would be much worse without some dramatic changes that occurred since 1996 when patients started to be given the so-called anti-AIDS cocktail. In comparison, in 1993 there were 78 deaths with 50 of these people having died within a year of finding out about their disease. No patient survived past 14 months.

Survival of the Species

Data from the consortium UNAIDS, which is a joint effort between several UN agencies and the World Bank, last December there were 36,1 million people contaminated with the HIV virus in the world. 25,3 million of them were living in sub-Saharan Africa. While 95 percent of AIDS victims live in poor countries, more than 90 percent of those who get adequate treatment for the disease live in rich nations.

The AIDS epidemic has already killed 21.8 million Africans. In the year 2000 alone more than 3 million Africans died from AIDS while 5.3 million others were infected by the disease. Thanks in great part to AIDS, life expectation in Africa has fallen to around 40 to 45 years. While Africa carries a disproportionate burden with 70 percent of the cases (having 10 percent of the world population) and 17 million AIDS caused deaths, Brazil would be in a much worse shape than it is today if it weren't for some courageous measures taken by President Fernando Henrique Cardoso, often criticized for his neglect of social problems. Against the reasoning of aides and political allies who advised him to cut the budget of AIDS programs when the Brazilian economy was showing signs of imminent crisis at the beginning of 1999, Cardoso chose to continue funding it.

Former President José Sarney—a conservative, he was the first civilian president after the military dictatorship that lasted from 1964 to 1985— in 1996, became an unlikely ally. As a senator for the state of Amapá he sponsored in congress a law that guarantees every AIDS patient in Brazil, regardless of his or her financial capability, the best treatment available. In an interview with The New York Times, Sarney talked about being made aware of the triple therapy that could reduce the presence of HIV to undetectable levels and that was announced during a Vancouver, Canada, AIDS conference: "A doctor friend informed me about what was going on in Vancouver. 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."

The same World Bank that in the '80s and '90s together with the IMF (International Monetary Fund) advocated a "structural adjustment" that decimated health budgets all across the developing world estimates that the cost preventing AIDS in Africa is over $2 billion, while there is no more than $160 million available for this fight. Today African countries are looking towards Brazil as an inspiration to fight and threaten multinational laboratories that charge prices extremely high for their AIDS medication.

Seven countries alone—US, Canada, Japan, Germany, France, England and Italy—bring to the pharmaceutical laboratories 80 percent of their revenues and an even bigger share of their profits. Deriving a ridiculous 1 percent of its sales from Africa, the big labs could afford to be humane and do humankind a favor by giving their anti-viral drugs away for free. But for years they haven't lowered a cent in their extortive prices, more interested in answering to corporate interests than save lives. They wouldn't consider offering a discount to poor countries lest their clients in the US and Europe would find they were being gouged and demand equal treatment.

According to Jean-Hervé Bradol from Médecins Sans Frontières AIDS is the locomotive for remedies in general. In the wake of AIDS the question of access to drugs is very important for diseases such as tuberculosis and paludism. Some of these remedies are not manufactured anymore—like the ones that fight the sleeping sickness. And for 20 years there haven't been investments in the research of tropical medicine."

Pirate Brazil

The Brazilian story is still being written and it's not without controversy, foes and defamers. In order to make the AIDS treatment affordable, Brazil decided to copy patented drugs and to replicate them in its laboratories. The country is now producing 8 of the 12 drugs commonly used in the AIDS cocktail. Since 1998 when it started making copies of brand-name medications to treat the disease, the country was able to reduce by 80 percent the cost of such drugs. The same triple drug cocktail treatment that costs around $10,000 a year in the US and Europe can be offered for $2,000 in Brazil and this price tends to go down to $700 or even less as the nation improves its technique and convinces international labs to lower their prices.

Unabashedly the country made drug piracy an official undertaking. Brazil has been a paradise for pirates of all kinds of products: from Rolex watches to Levi's jeans, from French perfumes to American computer software. But now, invoking humanitarian reasons contemplated in international agreements, the poor Brazilian government started to copy patented formulas from rich and stingy laboratories to save lives that otherwise would be lost. The program of free distribution of antiretroviral drugs started in 1996.

To produce the medicines Brazil had to find the raw material in countries like China and India, which disregard the international law of patents. But the nation continued to buy from foreign labs two essential products in the fight against AIDS: Efavirenz produced by Merck Sharp & Dohme and Nelfinavir manufactured by Roche. In a package of 12 drugs, these two alone consumed 36 percent of the $306 million spent by the Health Ministry in the purchase of AIDS drugs. Tough-talking José Serra, the Health Minister, let it be known that the country would end up manufacturing all AIDS drugs unless the laboratories would substantially cut their prices.

Not that the Brazilian government does not believe in intellectual property and in the importance of drug patents for medical research and the development of new medications that otherwise would never be produced. Six years ago, Brazil was one of the first nations to adopt legislation based on the criteria established by the World Trade Organization. According to Brazilian law, drugs produced before 1997 can be replicated in the country, but not those that were released since that year.

It is estimated that a laboratory spends between $400 million and $1 billion to develop a new AIDS drug. Merck, Sharp, & Dohme said that it spent six years of research and half a million dollars to develop Efavirenz, one of the drugs Brazil threatened to pirate. The equipment Brazil purchased to replicate the medicine cost much less: $250,000. It was acquired by Far-Manguinhos, a public laboratory associated with publicly-owned Fundação Oswaldo Cruz. And the laboratory believes that it will be able to copy the Merck drug by September.

Wrote The New York Times Magazine on a superb cover story by Tina Rosenberg on the status of AIDS in the world and the Brazilian contribution to solve the worldwide AIDS crisis: "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."

And the article continues: "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 of 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."

Brazil is already starting to export its technology for the manufacturing of AIDS drugs as well as control of quality techniques and ways of administering the medicine, much of this for free. A delegation from Burkina Faso, Africa, has visited the country recently to learn how Brazilians are managing their AIDS predicament. The government has also signed cooperation pacts with Angola, Guinea-Bissau, Mozambique and São Tomé and Príncipe.

International aid group Oxfam has joined the increasingly loud chorus of those defending the idea that Third World countries should be allowed to copy drugs and to manufacture them at much cheaper prices not only to treat AIDS but also to deal with respiratory tract infections and childhood diarrhea. Oxfam has also appealed to Washington and major pharmaceutical labs to drop their suits against countries that are copying patented AIDS drugs. In a statement released recently Oxfam explained its position: "This industry campaign has been led by the Pharmaceutical Research and Manufacturers of America (PhRMA), one of the worlds most politically influential and well-financed industrial lobbies. The primary source of PhRMA's power is its influence over the office of the US Trade Representative, which has repeatedly backed its claims with the threat of trade sanctions."

Mark Grayson, spokesman for PhRMA, responded that his organization has the same concerns as anybody regarding access to affordable drugs in developing nation and blamed the poor countries for not having an infrastructure good enough to take advantage of a possible deal with labs. He also accused some governments of having little interest in health matters. As for Brazil, Grayson, as expected, doesn't like the government's approach: "We believe Brazilian officials have had some good efforts putting resources toward this major problem, but they are still part of the world order and need to work things out with our companies." In an interview with weekly newsmagazine Veja he was even more incisive: "I'm sure Brazil is already paying prices well below those charged other developing countries. What else does the Brazilian government want? The same treatment as Botswana?"

The Goliaths Brazil decided to face and who have a powerful godfather mostly in the government of the United States have names like Boehringer Inelheim, Bristol Myers Squibb, Glaxo Wellcome, F. Hoffmann Laroche and Merck and Co. Only in May, 2000, these five pharmaceutical giants agreed on giving discounts for their AIDS drugs to poor nations. Senegal, Uganda and Rwanda were able to sign secret agreements with the labs with the price charged not being publicly revealed. The government of Ivory Coast also disclosed that the laboratories Glaxo SmithKline, Bristol Myers Squibb and Merck decided to sell them antiretroviral drugs discounted up to 90 percent. That would allow the country to spend as little as 1,200 in AIDS drugs to treat a patient for a year.

Only in recent weeks, after much posturing and threats of suits, however, the giant laboratories started to be more flexible in their discussions with Brazil. It helped a lot that the country has shown determination, starting to produce its own generic drugs and seriously contemplating the patent breakage of some intransigent companies. This didn't go well in Washington though, and the democratic administration of Bill Clinton has taken Brazil to the World Trade Organization's Dispute Settlement Body. The country is being challenged in its program of distributing free drugs to AIDS patients.

No wonder there were no takers, last year, when the Clinton administration made available $1 billion through the Eximbank to fight AIDS. It happens that the money was a loan charging regular commercial interest rates. Besides, the borrowers were supposed to buy drugs from American laboratories for the full price they are sold in the US. It was inevitable that such arrangement would generate the universal chorus of "thanks, but no thanks" that it did.

Doubts, doubts

Even among AIDS researchers the Brazilian effort was questioned early on. Some doubted that Brazil would have the technology to produce proper generic equivalents. Others feared that a mismanaged program with people taking the drugs irregularly would create more resistant strands of the HIV virus. "I was against the Brazilian program at first," said Brazilian Mauro Schechter, one of the world's most respected AIDS researchers who is head of Universidade Federal do Rio de Janeiro's AIDS Research Laboratory. "I thought it would be very expensive and difficult to establish the necessary lab infrastructure. But the program has been very effective." He admits, however, that some of Brazil's generic drugs may not have the same quality of the top name brands.

Why did Brazil lead the way in this worldwide war? Brazil was the only nation smart and brave enough to take advantage of a "loophole" in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), a pact practically imposed by the international lobby of several multinational groups on the World Trade Organization (WTO). The treaty that gives pharmaceutical companies the right to hold to their patents and charge as much as they wish for a drug for the period of 20 years, also, recognizes the right of a nation to break a patent in case of national emergency.

Before the Brazilian chutzpah act, however, this clause had no teeth. Countries that tried to invoke the emergency clause were massacred by the threatened laboratories and by Washington. When South Africa and Thailand, for example, tried to manufacture their own AIDS drugs, the American government sided with the pharmaceutical industries and threatened with trade sanctions. They seem intent also now in dissuading Brazil from selling the generic AIDS drugs it produces to third countries. They would also like to forbid these countries from obtaining the Brazilian medicine.

For UN secretary general Kofi Annan, part of the success of the Brazilian experience should be attributed to the government's decision to manufacture its own AIDS drugs even without the permission of the laboratories that developed the medicine. Persistence was the other factor of this equation. Despite all the cost involved and the pressure from the Catholic Church and other conservative forces against the ample distribution of condoms and educational campaigns about AIDS and how to prevent it the Health ministry went ahead and was able to control the disease.

While other countries with similar AIDS epidemics have adopted programs similar to those implanted in Brazil only rich countries like the US were able to give continuity to them in a so large a scale. The Brazilian open attitude about sex and the mobilization of the gay community were fundamental since the beginning of the fight against the AIDS epidemic. Brazilian campaigns on AIDS awareness were taken not only to the airwaves and the pages of the press but also to churches' and nightclub's doors, to prostitution areas and gay clubs. The Brazilian youngster has become the best informed in the world about the AIDS virus, according to a UNAIDS study. Tens of millions of condoms have been distributed for free and annual consumption of the product has reached 320 million units. Drug addicts can also easily get disposable syringes.

Being a pioneer in the treatment of AIDS victims has taught Brazilian health officials some precious lessons that are helping patients themselves and the national AIDS treatment program. Artur Kalichman, coordinator of the São Paulo Program of AIDS Combat, has found out, for example, that stronger drugs shouldn't be used before the patient shows symptoms of the disease. "We soon noticed," he told weekly Veja magazine, "that it is more convenient to wait for the first symptoms of immunological weakening instead of attacking the HIV as soon as it is found in the organism." This procedure not only frees patients from side effects from drugs they don't need now since the disease can sometimes take years to manifest itself, but also allows more people to enjoy the benefit of these expensive and helpful drugs.

A Breakthrough

In March, after lengthy negotiations with the Brazilian Health Ministry, New Jersey-based Merck announced that it was cutting the price on Efavirenz and Indinavir, two of its AIDS drugs. It was a significant drop. The Efavirenz capsule had its price reduced from $2.32 to 84 cents (64 percent) and the Indinavir was reduced from $1.62 to 47 cents (71 percent). According to the Health Ministry, Brazil will save $38 million a year with the discounted price. "This is a big victory that was possible only because Brazil has been fighting for this here and overseas," said outspoken Health minister José Serra. "The price offered is lower than what we would get by breaking the patent and producing the drug in the country."

On March 30, one day after announcing the price-cuts by Merck, the Health Ministry revealed that it would once again appeal to Swiss drug maker Roche Holding AG to also cut the price of its AIDS drug, Nelfinavir. Together with the appeal there was again a threat that the country could break the patent of the medicine and start to produce the drug as a generic as soon as June.

The ministry said also that the state-owned Far-Manguinhos laboratory will keep studying the composition of the Nelfinavir in order to replicate it, since the 13 percent cut announced by Roche a few weeks ago was not good enough. "If an agreement isn't reached, the Health Ministry will ask for compulsory licensing for national laboratories to produce Nelfinavir," said the ministry spokesperson.

Reacting to the Merck's announcement, Paulo Teixeira, coordinator of the AIDS National Program, said that "for the first time in the history of the market economies, a multinational was guided by UN's HDI (Human Development Index). "We have here," Teixeira said, " a differentiated price charged according to the paying ability of each country." While the tablet of Efavirenz is being sold for 84 cents in Brazil, they are paying 45 cents for it in Africa and $4.32 in the US.

This drug is being taken by 15 percent of the 95 patients being treated for AIDS in Brazil and represented 11 percent of the cocktail's whole price. Roche's Nelfinavir is used by 23 percent of the patients and is consuming now 23 percent of the money spent in AIDS remedies.

High Times

The explosive arrival of AIDS in Brazil, in 1985, coincided with the end of a repressive and moralistic military dictatorship that had lasted 21 years. There was a new generation ready to experience life, sex, and drugs to the fullest, ready to use the pill but unwilling to wear condoms, following the letter of Milton Nascimento's lyrics: "any kind of love is worth loving." An explosive combination guaranteed to easily spread a disease that's mostly transmitted through sex and contaminated syringes. It's not by coincidence that 66 percent of the AIDS victims in São Paulo were born between 1955 and 1971. They were between 14 and 30 years of age when the disease started to spread in the country.

"It was the generation that didn't trust anyone over 30 and lived the time of the so-called free love, with heterosexual practices and growing homosexual permissiveness," according to São Paulo economist and PUC's (Pontifícia Universidade Católica—Pontifical Catholic University) professor Samuel Kilsztajn, 49. He is the co-author of the study Notified Cases of AIDS in the State of São Paulo _ The Vulnerable Generation.

Among the celebrities who were taken by the disease were Cazuza, singer-composer who was born in 1958 and died in 1991; rock composer Renato Russo who died in 1996 at age 36; soap-opera leading man Lauro Corona who was a TV sensation when he died in 1989 (he was born in '57) and Cláudia Magno, another TV actress who died at age 34, in 1994.

With the worse behind, Brazil now is afraid that people will forget the times of fear. Half of those being infected by AIDS today are young people who didn't experience first hand the full blow of the epidemic Recent research shows that the AIDS explosion of cases in 1985 didn't translate immediately in a great number of deaths due to the nature of the disease that takes an average of eight years to reveal its symptoms. It took ten years for the 1985 explosion to show in the death statistics. In 20 years of epidemic the worst year was 1995.

While homosexuals were the first to be infected, there was a second outbreak that affected mainly those using intravenous drugs. Most recently heterosexuals have been the main victims of AIDS due to the initial misconception that this was a gay disease. Much has been said and written about the feminization of the disease in Brazil. Most of the women are married living in a monogamous relationship and are being infected by their husbands. For Health Minister Serra this development was anticipated by health experts. "There was no surprise there because the Ministry was following this growth. Now we have to improve our prevention work among women, and they need to adopt a more assertive posture in order to avoid the contamination."

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