back
|
 |
Volunteers or victims?
By: Julian Borger
The Guardian, March 14, 2001
Antonio Salvador Polizzi was a 60-year-old pen salesman
with a heart problem. Three years ago, when he woke up in the early hours
of the morning with chest pains, his family rushed him to the Pedro Mallo
naval hospital, a huge blue edifice studded with portholes in the Buenos
Aires suburbs which was supposed to be one of the city's finest.
Mr Polizzi never left the hospital. Five days later, on January 9 1998, he
was dead. The family's distress was made all the more agonising by the
fact that the hospital managed to lose his wedding ring, his watch and his
clothes.
To the rest of the world rushing through the hospital's corridors it was
just another hard-luck story of a man whose time had come. But it was much
more than that. The nature of Mr Polizzi's death and the deaths of other
heart patients at the naval hospital are at the centre of a scandal which
has shocked the Argentinian medical community and raised ethical questions
over the explosive growth of the pharmaceutical industry's role in Latin
America and the rest of the developing world.
Six months after Mr Polizzi died, his widow, Aida, got a call from a state
prosecutor, summoning her to his office. She thought it must be about the
ring, but when the prosecutor told her what it was really about, she
fainted. He said that her husband had been enrolled in a clinical trial
for a new heart drug called cariporide. The family say this was without
his knowledge. They have testified that the signature on the consent form
was not his, and later tests have proved this according to the prosecutor
who is still conducting his investigation.
Forged
"It was not even close. The handwriting was completely
different," Andrea Polizzi, the dead man's 26-year-old daughter said.
At the date and time Mr Polizzi - the Argentinian representative for Cross
pens - was supposed to have signed, he had been unconscious. He appeared
to have had two separate clinical histories: one real, one forged,
complete with bogus electrocardiograms which appear to have been taken
from other patients' files.
The Corgiolu family have a similar story to tell. Luis Antonio Corgiolu, a
66-year-old technical college instructor, had gone to the hospital with
chest pains, and died the next day. The doctors said he had had a hole in
his aorta, and there was nothing they could do. Six months later, the
Corgiolus got a call from the prosecutor's office and were shown a consent
form for the cariporide trial with Luis's name on it.
"But it wasn't his," Martin, his eldest son said. "He
always signed with his nickname, Lucho. This was his full name."
When prosecutors looked at the consent forms for all 137 patients at the
hospital who had been part of the trial, they found evidence that 80% of
them had been forged. The files were also filled with duplicated
electrocardiograms. The hospital says it will press charges against the
accused doctors.
Doctors had been offered $2,700 (£1,900) for each person they recruited
for the trial by cariporide's German-based manufacturers, Hoechst Marion
Roussel. The family's claim that in pursuit of the cash, criteria set by
the manufacturers for who should be included in the trial were ignored.
At least 13 people included in the trials between 1997 and 1998 died. The
chief prosecutor, Lucio Herrera, believes he has sufficient evidence to
prove that three of the deaths were caused by the drug or the way it was
administered. The evidence is likely to be hotly contested if and when the
case finally comes to trial.
No formal charges have yet been made, and there is no suggestion that
Hoechst (now part of French-based Aventis Pharma), nor the US contractor
it hired to carry out its Argentinian trials, Quintiles Transnational,
were in any way responsible. Both Hoechst and Quintiles spotted
irregularities in the spring of 1998 and alerted the hospital and the
Argentinian authorities.
But the case nevertheless demonstrates the dangers involved in the rapid
expansion of clinical trials in Latin America, Africa and Asia. As
increasing numbers of experimental drugs are emerging from the
laboratories of Europe and the US, amid increasing pressure to deliver
instant cures, the pharmaceutical companies are running out of suitable
patients to act as guinea pigs in their home countries. The developing
world is virgin territory, with millions of potential subjects. And in
most cases they are being used to test medicines aimed not at them, but at
the lucrative markets of the first world.
In its May 2000 edition, CenterWatch, a newsletter for the burgeoning
clinical trials business, published an exuberant article under the title
Latin American Fever in which it said the continent "may offer a
unique opportunity to reach much larger numbers of study subjects."
The pattern is replicated across the developing world. One of the world's
top five drug companies, Eli Lilly, tested 590 patients in 1994 across
Africa, the middle east and central and eastern Europe. This year the
company expects to run tests in those regions on 7,309 patients.
There are fears that this mushrooming of third world trials is leading to
a loosening of the tight regulations that exist in the west. Recent
US-government funded studies in Africa designed to show the effectiveness
of the anti-Aids drug, AZT, in preventing the transmission of HIV from
mother to infant during pregnancy, included a placebo group - a practice
that would have been unacceptable in the US or Europe. AZT has been proven
to save lives and so the denial of the drug to trial participants would
not have been considered ethical.
Concerned doctors attempted to persuade the US National Bioethics Advisory
Board last November to establish rules so that US government-funded
medical research would have to be overseen by a US review board, but the
attempt failed, leaving international controls on the drug trial business
patchy.
Clinical trials
In Buenos Aires, Luis Zieher, head of the medical ethics committee, said
that eight years ago, his panel used to appraise three to four proposed
drug trials a month. Now it examines up to 20 a month.
There were about 200 clinical trials in Argentina last year, each one with
up to two dozen different test sites (the naval hospital was only one of
26 Argentinian sites in the cariporide trials). Across Latin America there
were more than 1,000 trials, according to Daniel Campos, an Argentinian
oncologist whose company, Salud Uno, puts drug companies in touch with
doctors interested in conducting trials. He said that number would
increase tenfold in the next two years.
"This is reasonable," Dr Campos said. "We have a huge
population, in big cities, so it could be done. But we are also developing
countries so we have big inefficiencies, so accidents can occur."
The appearance before Christmas of a report on the scandal in the
Washington Post caused outrage in Buenos Aires.
Norberto Pallavicini, a senior official at Anmat (the National
Administration of Medicine, Food and Medical Technology) which oversees
clinical trials, pointed out: "Our medical facilities are recognised
as the most important in Latin America. The trials are coming here because
Argentina has credibility and the highest level of medical
knowledge."
Anmat has 30 full-time medical inspectors who have the reputation of being
the best on the continent, but even he con cedes that his organisation is
facing an "explosion" in the number of trials: "We are not
going to be able to supervise all the trials on a permanent basis."
The doctor supervising the cariporide trials, Luis Garre, has been sacked
by the hospital, but claims that he is innocent. In an interview with the
Guardian at his flat, he said: "I've been morally and professionally
devastated.I've been left without work, and I've had to take the
blows."
Dr Garre denies cariporide was responsible for any deaths. It had been
intended to limit damage to the heart after episodes of angina or bypass
surgery, but the worldwide tests, involving more than 11,500 patients in
23 countries, showed little benefit.
They also showed it to be safe when administered to patients with the
targeted conditions.
An Aventis spokeswoman, Lori Kraut, said that although the trials were
called off, "there were no safety issues in the discontinuation of
the drug". It is currently being tested for other possible medical
uses.
She insisted that doctors in the developing world were no more likely to
break the rules than their counterparts anywhere else.
Tomorrow: How drug companies bestow their favours on British doctors - the
last in the series.
|
