Movie mirrors drug firms' antics

Ralph Fiennes searches for the truth about his wife's death in the film of John Le Carre's book The Constant Gardener.

In a dusty schoolyard in Kano, northern Nigeria, a group of children are kicking a football. One solemn-faced boy called Anas sits watching quietly. He cannot play because he has pains in his knees that prevent him from running.

Nobody knows what caused Anas' pain but suspicion has fallen on Big Pharma. Six years earlier, Anas had been 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 The Constant Gardener, the film based on the novel of the same name by John Le Carre, which opens in London next month and in New Zealand on November 17.

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

As with other 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.

Tessa, an activist and 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 he sets out to complete what she started.

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 Africans 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.

After the credits, a note from Le Carre appears on screen : "Nobody in this story ... is based upon an actual person or outfit in the real world. But ... 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 giant that is testing a drug on mothers and children and quietly burying its failures.

But even without suggesting such a gargantuan conspiracy, the behaviour of the pharmaceutical industry - from the price protection of Aids drugs to the cover-up of lethal side-effects to protect profits - is well documented.

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. In 1996, Kano was suffering from outbreaks of cholera and measles when a third, even more deadly, disease arrived: meningitis. 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 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 earner. But Trovan had never been tested on children.

The Infectious Diseases Hospital in Kano was under siege from desperate parents and their dying children. One was Anas, then aged six. His father, Mohammed, said his son was given a drug by "a doctor from overseas". Mohammed assumed the doctor was from Medecins Sans Frontiers, an independent medical organisation.

Only later did he realise that Anas had been included in a trial of the new drug Trovan.

His story was told in the British Channel 4 documentary Dying for Drugs, broadcast in 2003, which alleged that Pfizer had failed to get informed consent from the parents and had backdated a letter granting ethical approval for the trial from 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 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' knee problem was caused by the drug or was a consequence of the meningitis. Trovan was later withdrawn from the market 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 Trovan trial children 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 Carre during the development of The Constant Gardener. 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.

After watching it and reading other material 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."

A second case of dubious practice also has echoes in The Constant Gardener. A Canadian specialist, Dr Nancy Olivieri, of Toronto's Hospital for Sick Children, was a leading expert 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 from the blood iron which builds up in patients with thalassaemia and can be fatal. At first the trial went well, then Dr Olivieri noticed worrying liver changes in some of her patients. She raised her concerns 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.

Apotex vice-president Mike Spino informed her that the trial had been terminated and warned of legal action if she spoke about it to anybody.

That triggered a dispute between Dr Olivieri and Apotex that has dragged on for more than five years. 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.

Deferiprone is now licensed in more than 24 countries and Apotex insist it is safe and effective. The company has accused Dr Olivieri of errors in the trial making 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 paranoid, there are real issues to confront.

The bigger scandal lies not in the forging of consent forms to clinical trials, or 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.

This, unfortunately, does not provide for a blockbuster thriller.

- INDEPENDENT