The true story of how multinational drug companies took liberties with African lives

Nobody knows what caused Anas' pain but suspicion has fallen on Big Pharma. Six years earlier, Anas was a patient in a trial of a new drug run by one of the world's biggest companies. A known side effect of the drug, called Trovan, was joint pain. The issues raised by Anas' story have become the subject of a major British film.

The multinational pharmaceutical industry is bracing itself for an uncomfortable autumn. Next month, The Constant Gardener, the film based on the novel of the same name by John Le Carré, opens in London.

Directed by Fernando Meirelles, of City of God fame, it is a thriller, a love story and a blistering attack on the drugs industry and the way it carelessly expends the lives of innocent citizens in the Third World in the quest for billion-dollar medicines to sell to the first world.

As with dramas of this kind - such as the 1999 film, The Insider, which detailed the perfidious dealings of the tobacco industry - it raises the question of how far fiction resembles fact. So it is worth examining the background to The Constant Gardener. The film opens in a remote area of northern Kenya where Tessa Quayle (played by Rachel Weisz), the wife of a British diplomat, has been murdered. Her travelling companion, a local doctor, has disappeared, and the evidence points to a crime of passion.

At the time of her death, Tessa, an activist and passionate campaigner, was on the verge of uncovering a conspiracy involving the testing of a new drug. In personality she was the opposite of her husband, the mild-mannered Justin Quayle (Ralph Fiennes), whose chief passion is his plants - he is the gardener of the title.

But in his grief, and goaded by whispers of her infidelity, he sets out to complete what she started, embarking on a quest to expose the truth about the pharmaceutical industry.

What he uncovers, as the film's blurb puts it, is "a vast conspiracy, at once deadly and commonplace, one that has claimed innocent lives - and is about to put his own at risk". At the centre of this conspiracy is the idea that pharmaceutical companies use African people to test drugs which are destined to become huge profit-earners in the West.

It is not the first time such allegations have been made, but they have rarely been levelled with such dramatic effect. Some will find The Constant Gardener's thesis overblown, but it is a gripping thriller, ravishingly shot by César Charlone, that conveys the chaos, grandeur and darkness of Africa with unequalled authenticity. After the credits roll, a note from John Le Carré appears on screen that reads: "Nobody in this story, and no outfit or corporation, thank God, is based upon an actual person or outfit in the real world. But I can tell you this; as my journey through the pharmaceutical jungle progressed, I came to realise that, by comparison with the reality, my story was as tame as a holiday postcard." This is hard to credit. The film features two brutal killings, a savage beating, a campaign of harassment, intimidation and threats involving two governments and their security services - all to protect the interests of a pharmaceutical company that is testing a drug on mothers and children and quietly burying its failures.

Maybe there are pharmaceutical companies that have engaged in such crimes and enlisted the support of corrupt governments. Who can say? But it is not necessary to posit such a gargantuan conspiracy, where paranoia is the only rational response. The crimes of the pharmaceutical industry - from the price protection of Aids drugs which have denied life-saving medicines to millions, to the cover up of lethal side effects to protect profits - are well documented.

But there are two cases in which named companies have been accused of wrongdoing that partly inspired The Constant Gardener and which give resonance to the allegations about the secret testing of drugs on the unsuspecting and the suppression of any negative findings.

In 1996, Kano was suffering from outbreaks of cholera and measles when a third, even more deadly, disease arrived: meningitis. The infection spread quickly through the cramped slums of the city and within weeks thousands of children were ill.

The outbreak was not reported in the West but it did not go unnoticed. An internet message alerted scientists at the research headquarters in Connecticut, of one of the world's biggest drug companies: Pfizer.

The company reacted swiftly. It chartered a plane to Kano with a new drug called Trovan that was a potential life-saver and a potential billion-dollar profit earner. But Trovan had never been tested on children.

The Infectious Diseases Hospital in Kano was under siege from desperate parents who brought their dying children begging for help. One of these was Anas, then aged six. His father, Mohammed, said his son was given a drug by "a doctor from overseas" and put to bed. Mohammed assumed the doctors who treated his son were from Médecins Sans Frontièrs, an independent medical organisation, who had arrived several weeks before the Pfizer team.

Only later when he examined a card he was given did he realise that Anas had been included in a trial of the new drug Trovan. The card was numbered 0001 - Anas was the first.

His story was told in the Channel 4 documentary Dying for Drugs, broadcast in 2003, which alleged that Pfizer had failed to obtain informed consent from the parents of the children tested, and had back-dated a letter granting ethical approval for the trial from the ethics committee of the Aminu Kano Teaching Hospital. Pfizer said it remained satisfied the Kano experiment was conducted properly.

Since the trial, Anas has had a pain in his knee which X-rays showed was inflamed and which prevents him from running. Trovan was not used in the US because it caused side effects including joint pain. It is impossible to tell whether Anas's knee problem was caused by the drug or was a consequence of the meningitis. Trovan was later withdrawn from the market for unrelated reasons, after it was linked with a number of deaths of patients from liver damage.

But the case against Pfizer did not end there. Lawyers seeking damages for the children involved in the Trovan trial obtained a letter sent by Pfizer's childhood diseases specialist, Dr Juan Walterspiel, protesting strongly about it. Dr Walterspiel set out eight grounds for opposing the trial including the fact that Trovan had "not been tested for its sensitivity before the first child was exposed to a live-or-die experiment." His contract with the company was terminated soon after.

Brian Woods, who made Dying for Drugs, met Meirelles and Le Carré, during the development of The Constant Gardener. "We had an entertaining lunch in which we were all frothing about the pharmaceutical industry," said Woods, who last week won a commission from Channel 4 to make a follow-up film.

Meirelles, whose Brazilian background gave him a strong interest in the issue of first world/Third World exploitation, distributed copies of Dying for Drugs to cast members, and it had the desired effect. After watching it and reading other background material that Meirelles had given him, Ralph Fiennes said: "There are huge questions about Big Pharma. The companies are not obliged to disclose a lot of information about how they test or make their drugs. There's big, big money involved." Rachel Weisz concurred. "It's David and Goliath; the little people taking on the big corporations. They [the pharmaceutical companies] make all this money, yet people in developing countries can't afford the drugs that could save their lives."

A second case of dubious practice by the pharmaceutical industry also has echoes in The Constant Gardener. A Canadian specialist, Dr Nancy Olivieri of Toronto's Hospital for Sick Children, was among the world's leading experts in the blood disorder thalassaemia when she agreed to take part in the trial of a new drug, Deferiprone, made by the US company Apotex.

Deferiprone helps clear iron from the blood which builds up in patients with thalassaemia and can be fatal. At first the trial went well and Dr Olivieri published promising results in The New England Journal of Medicine.

Then she noticed worrying liver changes in some of her patients. She raised her concerns with the company and tried to find a way of adapting the trial. But she was unprepared for the response of the company, whose potential million-dollar drug she was now questioning.

Mike Spino, the vice-president of Apotex, informed her that the trial had been terminated, and warned her that she would face legal action if she spoke about it to anybody, in breach of her duty of confidentiality.

That triggered a dispute between Dr Olivieri and Apotex that has dragged on for more than five years, during which she has not published new research. Sir David Weatherall, Regius Professor of Medicine at Oxford University and a supporter of Dr Olivieri, said the case raised a "fundamental issue of academic freedom". Nor was it an isolated case. Sir David added that editors of medical journals including The Lancet and The Journal of the American Medical Association had come under pressure not to publish data or to change it.

This story is also told in Dying for Drugs. Deferiprone is now licensed in more than 24 countries, including the UK, and Apotex insist it is safe and effective. The company also accused Dr Olivieri of making errors in the trial that made her results worthless.

Wherever the truth in the cases of Pfizer and Apotex, the behaviour of Big Pharma will come under renewed scrutiny thanks to The Constant Gardener. Even if its picture of multinational corporations engaged in global conspiracies with corrupt governments seems excessively paranoid, there are real issues to confront. The bigger scandal lies not in the forging of consent forms to clinical trials, nor even in the intimidation of recalcitrant researchers. It lies in the rapacious pricing of the pharmaceutical industry that puts life-saving drugs out of reach of individuals, hospitals and even nations. The words used to justify these prices are "research and development". But in truth, the industry's biggest cost is marketing. Extraordinary sums are spent persuading doctors to prescribe new drugs only fractionally different from older, cheaper ones, which ramp up prices.

Great as this conspiracy is, unfortunately it does not provide for a blockbuster thriller.