Big Pharma's human guinea pigs
The
true story of how multinational drug companies took liberties with African lives
The pharmaceutical industry is bracing itself for criticism when the film 'The
Constant Gardener' opens next month. But Jeremy Laurance reports that away from
the Hollywood script is a true story of how multinational drug companies took
liberties with African lives with devastating consequences.
Published:
26 September 2005
In a dusty schoolyard in Kano, northern
Nigeria, a group of children are kicking a football. One of them, a 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 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.