Free the Industry, Not the Drugs -- Richard Tren, Wall Street Journal Europe, 2002-07-11
Free the Industry, Not the Drugs
By RICHARD TREN
If chanting slogans and booing speakers could magically create new innovative drugs, this week's Barcelona AIDS Conference could be considered a raging success. Activists have certainly put their moral righteousness on display as they pour abuse on pharmaceutical companies. On Tuesday they prevented a U.S. cabinet member from speaking. The U.N. organizers of the conference have smiled benignly on it all. But despite the posturing, the idea that giving greater powers to government at the expense of the private drug companies will lead to more sustainable drug delivery is deeply flawed.
Much of the debate over drug patents has focused on the fear that the WTO treaty on Trade-Related Intellectual Property Rights, which covers pharmaceutical patents, will prevent poor countries from importing cheap generic drugs from Brazil, India or Thailand and other generic producers from copying future drugs. TRIPs will become legally binding after 2005 for some countries and 2016 for others. The treaty does make allowances for compulsory drug licensing for health emergencies, but the activists fear that the agreement gives drug companies too much power.
The Accelerating Access Initiative has been criticized precisely for this reason. The initiative is a partnership between the U.N., drug companies and countries designed to fast track improved treatment, care and support for those living with HIV/AIDS. The fear is that multinational corporations, which have made separate agreements with individual countries, can pull out at any time, which could compromise treatment programs. The corporations have been accused of imposing onerous conditions on developing countries to prevent them from importing cheap generics.
James Love of the Consumer Project on Technology, a U.S.-based consumer-rights organization, was recently quoted as saying that developing countries are afraid to opt for generic drugs because foreign aid is tied to brand-name drugs. Yet activists have always failed to show any concrete evidence to back up this charge. Developing countries can and do import generics or issue compulsory licenses in compliance with international law.
The drug activists would have us believe that while agreements and cooperation with the research drug companies is unsustainable, undermining drug patents and issuing compulsory licenses is sustainable. This is simply not true. It would seem obvious that a sustainable treatment solution requires that new drugs be developed constantly in order to cope with drug resistance.
Developing new drugs for the diseases that plague developing countries is vital. The encouraging news is that the total number of anti-infective compounds in development has risen by over 30% since 1997. However, according to Pharmaprojects, an organization that tracks the development of pharmaceuticals under development, the number of HIV anti-retrovirals has fallen by around one third over the same period.
Further, there are increasing reports of resistance to anti-retroviral treatments. According to a study by Dr. Frederick Hecht and published in the Journal of the American Medical Association, in some cases drug resistance was witnessed before treatment even began.
Innovation is therefore essential, but it did not feature much at the conference. The drugs industry wasn't even represented on a panel on Leadership and Drug Research. Moreover, the recent drop in HIV anti-viral compounds could be at least partly due to the threat of generic competition and the attacks on multinational companies, according to Dr. Des Martin, president of the South African HIV Clinicians Society. Why rush to develop new drugs if they will be copied by others?
For all the media attention they attract, the activists are no good at ensuring that there are incentives to develop new drugs. The drug-research companies are motivated by profit and have anxious shareholders to answer to. This is the way capitalism works; why should drugs work differently? Drug companies have a proud history of developing anti-retrovirals, but they need security over their investment. Countries should therefore be creating the right institutions to encourage their ongoing investment.
TRIPs has a bad reputation internationally; the activists only want us to know about its potential negative impacts. TRIPs however holds out great promise for innovators in developed and developing countries. That Brazilian generics producer FarManguinos has applied for patents for potential ARVs is a testament to this. Far from making AIDS treatment unsustainable, a strong interpretation of TRIPs creates the very foundation for sustainable treatment.
The activists argue that the only way to ensure sustainable treatment and low drug prices is to give as much power to government and NGOs as possible and encourage the use of generics. But in many parts of Africa, governments have chosen to turn a blind eye to the looming AIDS crisis; spending on the military frequently dwarfs that on health care. There are of course notable exceptions, such as Uganda. Some countries, such as Botswana, have chosen to partner with the research drug companies to ensure increased drug access. But success stories do not abound.
Generic drugs can certainly play an important role in any health system, but if AIDS patients in 10 years time are going to have any effective drugs (generic or otherwise), then the research-based drug companies will have to be encouraged to develop new treatments and vaccines. This means respecting intellectual property and providing a more conducive regulatory environment. It also means encouraging economic growth in other ways--and a good way to start is to create a culture that protects property rights, starting with those of the poor--so that a market for their products actually develops in Africa, India and China.
It does not mean imposing price restrictions or threatening compulsory licensing--such actions will only act as disincentives to the development and marketing of new drugs.
Mr. Tren is a director of the South Africa-based NGO Africa Fighting Malaria.
Updated July 11, 2002 1:13 a.m. EDT
UN Body got it wrong on DDT -- Richard Tren, Business Day, South Africa, 2002-07-09
Richard Tren critcises the INC6 meeting of the Stockholm Convention.
SIDA: eliminando el remedio -- Roger Bate y Richard Tren, Analitica.com, 2002-07-08
SA's necessary evil -- Sarah Duguid, Mail & Guardian, South Africa, 2002-07-05
SA's necessary evil
05 July 2002 07:00
A year ago in Stockholm an audience of government representatives and environmental groups applauded enthusiastically as Kjell Larsson, the Swedish Environment Minister, announced that a United Nations treaty banning or restricting 12 toxic chemicals, known as the dirty dozen, had been adopted.
The ban resulted from years of lobbying by environmental groups and its success was given added credence: even the United States, despite dogged rejection of other environmental agreements, not only signed the Stockholm Convention, but was instrumental in negotiating it.
By May this year 151 countries had committed to eradicating the dirty dozen, leading to an effusive declaration by Klaus Topfer, executive director of the United Nations Environment Programme and a driving force behind the convention: "The Stockholm Convention is clearly one of the greatest environmental accomplishments of the past decade."
Just 50 years ago, however, millions of Europeans and Americans owed their lives to one of the outlawed dirty dozen. If it wasn't for dichloro-diphenyl-trichloroethane (DDT) we would be living in a very different world.
During World War II The New Yorker reported that the First Marine Division had to be pulled from combat and sent to Melbourne, Australia, to recuperate. Ten thousand of its 17000 men were put out of action by malaria.
It would be a "long war" complained General Douglas MacArthur to Paul Russell, a malaria expert. The army desperately needed to find a solution if it was to win the war.
Paul M?ller, a chemist, had discovered DDT in the late 1930s while trying to find a chemical that would protect woollen clothing from moths. He was testing different powders by spraying them inside a glass box filled with house flies. DDT was so effective that even after the box had been scrubbed clean with acetone, the flies were being killed by miniscule traces of DDT left behind.
M?ller was working in Switzerland for the JR Geigy company. Excited by the discovery, Geigy sent 100kg of the white powder to its New York office. The year was 1942 and the powder was finally passed on to the US Department of Agriculture's entomology research station in Orlando, Florida. The Orlando laboratory had been given the task of developing pesticides to help the suffering US army.
The laboratory found that the powder could kill insects four times more effectively than its next best insecticide. It pushed ahead with development. After safety tests on humans caused no ill-effects, the Orlando laboratory had found its panacea. With the manufacture of DDT kept a closely guarded secret, it was shipped out in vast quantities to every Allied theatre.
Spraying and dusting missions began in earnest. A typhus epidemic was avoided in Naples after a million people were dusted with DDT. The US Army Air Force built DDT bombs by attaching 625-gallon tanks to the wings of bombers that sprayed vast areas in the tropics before troops arrived. DDT ensured the health and strength of thousands of men who would otherwise have been rendered unable to fight for up to five weeks.
Such was the importance and consequence to public health of M?ller's discovery of DDT that scientists could glimpse, for the first time, the possibility of a world free of insect-borne disease. In 1948 M?ller was awarded the Nobel Prize.
Riding the wave of DDT exhilaration, a Global Malaria Eradication Campaign was started after the war. Instead of piecemeal efforts by individual countries, mathematical models were devised and the ambitious global eradication programme was under way. Malaria was completely wiped out in North America and Europe within a few years.
At the time the programme was conceived opinion was divided about how malaria should be tackled. Was it more effective to kill the parasite by treating people with drugs or should the focus be on wiping out mosquitoes?
Social reformers argued that malaria mainly affected the poor and that to wipe out the disease social injustices needed to be removed.
Eliminating mosquitoes -- known as vector control -- was the American way. It had its critics, who suggested that global eradication through widespread spraying was a part of capitalism's fight against communism. It was an expansionist plan, they said, that did not take into account the needs of local people.
The political intricacies of the Cold War also complicated the programme, but in the end, the American way won and vector control became the preferred method of eliminating malaria.
Richard Tren, director of the NGO Africa Fighting Malaria, suggests that the failure of the global eradication programme was twofold.
A programme that relied solely on spraying to kill mosquitoes was folly -- though spraying programmes reduced the need for drugs to treat malaria, they should still be part of an eradication programme, he says. But the greater folly was the unilateral way in which the West devised the eradication programme -- it hadn't taken into account the budgets and infrastructure of developing countries.
South Africa began DDT spraying for malaria in 1946. Infections in the Transvaal rapidly dropped to a tenth of what they had been. Such was the success of DDT that the decision was taken that it only needed to be used after heavy rainfall. Complacency was another reason for the programme's failure. People thought, too soon, that they had won the battle against the disease.
DDT's faultless powers were first widely questioned in Rachel Carson's book Silent Spring, published in 1962 and seen by many as the foundation of today's environmental movement. Carson argued that the reckless spraying of DDT on cotton fields in the US in the Fifties had polluted the water system and was threatening the bald eagle, the symbol of America, with extinction.
Scientists dispute Carson's claims that DDT was responsible for problems with the bald eagle and have dismissed her book as deeply flawed. Tren points out that the back cover of the 1972 edition of the book states: "It makes no difference that some of the fears she expressed 10 years ago have proved groundless or that here and there she may have been wrong in detail."
Maureen Coetzee of the National Institute for Communicable Diseases in Johannesburg claims studies showed that 90% of the bald eagles found dead had been killed by gunshots.
DDT was finally outlawed for agricultural purposes in 1972 in the US and in 1974 in South Africa.
Malaria control programmes were still allowed to use DDT because they only used small quantities of the chemical inside houses. But gradually, over the years, a swell of opinion against DDT grew.
Leading the South African anti-DDT lobbyists was the Poison Working Group; a coalition between the Endangered Wildlife Trust and agrochemical companies. The South African government bowed to the pressure in 1996 and ceased using DDT altogether. It chose to use the more expensive, but effective, insecticide group known as pyrethroids.
In 1996 the Department of Health recorded 11000 cases of malaria in South Africa. In 1997 that figure jumped to 22000. The figure was alarming but fluctuations occur depending on rainfall and so the scourge was brushed aside as a temporary blip. But the figure continued to grow. By 2000, when 62 000 cases of malaria were recorded, the government became aware that it had the beginnings of a national emergency on its hands.
Worst affected was KwaZulu-Natal, where long queues of feverish patients formed outside hospitals. Manguzi hospital in KwaZulu-Natal, just 15km from the Mozambique border, had 750 patients but only 262 available beds. The province was being hit by the worst attack of malaria since 1931.
The number of infections was so high, that South Africa ran out of malaria drugs. Andrew Hunt was a doctor at Bethesda hospital in Jozini, KwaZulu-Natal, during the epidemic: "We started treating patients with anything we could get our hands on. We even used stuff that probably wasn't going to work. We got used to patients dying. I felt very defeatist. There was no answer. We were doing everything we could and the problem was just getting worse."
Keith Hargreaves, an entomologist at the Malaria Control Centre in Jozini, began investigating the sudden epidemic. He collected mosquitoes and, with Coetzee of the National Institute for Communicable Diseases, began trying to isolate the cause. To the scientists' surprise the mosquitoes were identified as Anopholes funestus, a species prevalent in southern Mozambique and now believed to have spread across the border, causing South Africa's malaria epidemic.
Of the thousands of species of mosquito, not all of which spread malaria, funestus is the most highly efficient transmitter of the parasite that causes the disease. Unlike most species it can transmit the parasite in winter. Funestus was still prevalent in southern Mozambique, but other than an isolated sighting in Tzaneen in 1975, DDT had wiped it out of South Africa in the 1950s.
The scientists also proved that funestus was resistant to pyrethroids, South Africa's chosen insecticide.
Research began into compounds that might control funestus. Only DDT worked.
In early 2000 these findings were sent to the health department in Pretoria. The government invited the Poison Working Group to a meeting in KwaZulu-Natal, where an agreement giving the group assurance of strict controls on the use of DDT was hammered out.
DDT was being reintroduced in South Africa just as the international community was moving to ban it. The health department diverted disaster funds to malaria control and stockpiles of DDT were located around the world and shipped to South Africa.
"DDT is a known risk," says Dr Gerhard Verdoorn, chairperson of the Poison Working Group, "but eight tonnes in five million hectares is negligible."
Spraying with DDT began in May 2000. By that time 330 people had died from malaria at four hospitals in KwaZulu-Natal. By 2001, after the DDT had started to work, there were 10 deaths throughout the whole year.
The facts are indubitable. But the problem isn't doubt surrounding DDT's efficacy as an insecticide, it is the clash of opinions on DDT's threat to the environment and human health.
The outlawed chemicals are known as persistent organic pollutants (POPs). They are dangerous because they don't biodegrade easily. In the US an orchid was found to contain 40% of the DDT that had been sprayed on it 20 years previously.
The chemicals can also travel long distances. When DDT was being tested in the US during the 1940s two duck ponds, several kilometres apart, were chosen as test sites. One was sprayed with DDT, the other was left untreated. Insects in the treated pond died immediately, but scientists were baffled to find that a week later those in the untreated pond had also died. When the ducks from the first pond went to the second there was enough DDT residue stuck to their feathers to work effectively.
The World Wildlife Fund (WWF), an environmental group at the forefront of the Stockholm Convention, argues that DDT is such a potent chemical that nobody will be safe as long as it is being used anywhere in the world.
This is the concern of Avertino Barreto, Mozambique's deputy national director of health, epidemiology and environmental health. Barreto says the World Health Organisation told Mozambique that it does not promote the use of DDT and that countries using it must phase it out. His department uses most of its budget to spray with pyrethoroids and steadfastly refuses to use DDT.
Last year Mozambique recorded three million cases of malaria in its popu- lation of 17-million. In some areas 90% of children under five are infected and malaria is the leading cause of death in children. Nevertheless, the health department says it wants a sustainable and long-term programme and says it needs $60-million to eradicate malaria.
Mozambique's health department resents pressure to reintroduce DDT, but its intransigence is leading pro-DDT campaigners to cry corruption. Campaigners say somebody, somewhere must be paying officials to reject DDT and use the agrochemical companies' new ranges of insecticides.
Whether the international community is the reason for Mozambique's reluctance to use DDT or an excuse (perhaps to mask the sheen of well-greased palms) the decision is costing the country dearly. Thousands are suffering and dying.
The country's health department acknowledges that "along with other illnesses such as Aids, [malaria] very much undermines economic development and poses a very serious challenge to the health sector".
The first cure for malaria, and one that is still widely used today, was developed by Jesuit missionaries in South America in the 17th century. They made quinine from the bark of the cinchona tree.
The drug was first exported to Europe in the 1630s. Some Protestants would not take it; they chose to die nobly rather than be saved by the Jesuit's powder.
A member of Mozambique's health department was quoted in the press taking a "if it's not good enough for Europe, it's not good enough for Africa" line. This is a logic as principled, and fatally flawed, as that of those early Protestants. Africa and Europe's need for DDT fall off opposite ends of the scale. What works in Europe will not necessarily work in Africa.
Africans are dying -- unwittingly -- for First World environmental principles and the WWF slogan "Lets leave our children a living planet" begins to sound very hollow indeed.
The US and the other countries involved in drafting the Stockholm Convention have not produced or used for many years any of the pollutants listed in the treaty. The US garnered no more than criticism when it refused to sign the Kyoto agreement restricting greenhouse gas emissions.
Some scientists say the threat DDT poses to the environment is containable and the threat to humans is non-existent. DDT, they say, is less poisonous than aspirin and less carcinogenic than coffee.
The Stockholm Convention on persistent organic pollutants will not affect Western economies. Tren argues that the treaty will aid European and American economies. The developing world still relies on certain POPs, such as DDT, but the West has already adopted new technologies. Insisting that the developing world make the same changes and buy more expensive chemicals takes away their competitiveness in the marketplace.
"[The banning of POPs] is geared towards benefiting developing countries, benefiting bureaucrats and benefiting the First World producers of the alternatives to POPs," says Tren.
In the early Nineties a US tobacco company warned Zimbabwean farmers that the US might stop buying its tobacco because Zimbabwe was using DDT to fight malaria. The US didn't want traces of DDT to find its way into cigarettes. The substance was (and still is) suspected of being carcinogenic.
Tren says such ludicrous reasoning amounts to nothing more than unjustified barriers to trade. Tariffs are widely criticised so governments use environmental issues instead, he says. That way, the economy gets what it wants and even the most politically conscious voter's concerns are assuaged.
The Democratic Alliance has also jumped on the bandwagon. Errol Moorcroft, the DA's spokesperson on environmental affairs, released a statement that said: "We question the wisdom of using an insecticide that is not degradable and that has a devastating effect on wildlife. DDT has been banned in most conservation-minded countries in the world."
A study by development economists Gallup and Sachs concluded that malaria reduces Africa's annual growth by an estimated 1%.
As it stands South Africa has no choice. There is no effective alternative to DDT and most scientists hold no hope that will change in the next 10 years, the time frame given by the United Nations Environment Programme for countries to find an alternative to DDT.
The market for agrochemical companies is agricultural pesticides; the public health market is small and unprofitable, so health departments have no option but to use insecticides designed for agriculture.
Hargreaves says: "DDT gives marvellous control of mosquitoes, but it does have a lot of drawbacks. If there were something else we would use it. But there is nothing else."
DDT sprayed on walls leaves behind a white, powdery smear and encourages bed bugs to flourish; unsurprisingly, the chemical is unpopular with communities.
Hargreaves is testing new insecticides for their mosquito-controlling properties, but so far has had no luck.
For DDT to retain its effectiveness it should be alternated with another pesticide. As things stand there is no alternative and genetic resistance will certainly begin to build. Africa's miracle weapon might yet lose its potency.
With problems such as this to contend with the scientific community has little time for the environmental community. "You can understand people's concern when DDT is found in whales' fat tissue," says Coetzee, "but environmentalists would have a lot more support if they didn't exaggerate. These people have little understanding of Africa and malaria."
Verdoorn, of the Poison Working Group, admits to having been shortsighted: "In the beginning, we were so green we were stupid. I hate DDT, but now we realise it's needed."
So, as bureaucrats in Geneva and Stockholm mooch around drinking organic cappuccinos and devising lengthy DDT forms for African health departments to fill in, it might be worth their remembering -- before they get too pleased with themselves -- that they are standing at the helm of a serious health problem. With political correctness taking the place of pragmatism and expediency -- and, human life -- a catastrophe is snowballing. A catastrophe for which this time Africa, with absolute justification, can lay the blame wholly at the feet of the West.
La guerra contra las patentes dificulta combatir el sida -- Richard Tren & Roger Bate, Todito.com, 2002-07-04
Richard Tren and Roger Bate argue against overriding drug patents in order to roll out drug access for HIV/AIDS patients.
DDT y la mortífera campaña de los verdes -- Richard Tren & Roger Bate, Observa, Uruguay, 2002-06-26
Richard Tren and Roger Bate write for this Montevideo based paper on the folly of anti-DDT pressure
El DDT y la mortífera campaña de los verdes -- Richard Tren & Roger Bate, El Tiempo, Colombia, 2002-06-25
Richard Tren and Roger Bate argue for the continued use of DDT in disease control and against environmentalist moves to ban the chemical in Latin America's second largest newspaper, El Tiempo of Bogota.
Doctors Without Principles -- Richard Tren, TechCentralStation, 2002-06-13
Richard Tren writes for TechCentralStation on Medecins Sans Frontiers decision to support Robert Mugabe in importing generic drugs to Zimbabwe.
Drug firms are allies in AIDS fight -- Richard Tren, Business Day, South Africa, 2002-05-03
Richard Tren writes on drug activism, Aids and access to drugs.
Deathly Bans -- Richard Tren, Tech Central Station, 2002-04-29
Richard Tren writes on the impact of the Stockholm Convention on Persistent Organic Pollutants on disease control.
Link between climate and malaria broken -- John Whitfield, Nature, 2002-02-21
A report on Simon Hay's study in East Africa that pours cold water on the link between climate change and malaria.
DDT Saves Lives -- Roger Bate, techcentralstation.com, 2002-02-14
"There is no doubt that the Mozambican floods of 2000 caused a surge in malaria, but rates were already far higher than they should have been. Sensible malarious countries around the world continue to use DDT to prevent malaria transmission, by spraying the inside of buildings where people work and sleep. DDT is the most effective mosquito repellent pesticide and easily the cheapest, so for poor nations its use makes perfect sense."
Rethink international treaties -- James S. Shikwati, irenkenya.org, 2001-10-25
In Kenya malaria incidents are high among communities around the coast and lake Victoria. The Victoria case presents a people grappling with poverty, which is partly due to two international treaties. The restrictions on DDT through the POPs treaty, which restricts their opportunity to fight malaria vectors cheaply, and the Nile treaty that prohibits them from irrigating land for agricultural use. Many have resorted to fishing as an economic activity. But yet again, cases of overfishing have been reported with Uganda banning Kenyan fishermen from using its section of the lake.
One may argue that introduction of irrigation may increase incidents of malaria around the lake. The fact that the resulting agricultural activities will greatly boost the incomes of the locals should not be ignored. This will put them in a position to fight malaria and remain prosperous.