New York: American pharma companies, taking
advantage of a Congressional provision, have been carrying out
clinical trials in poor and developing countries where the
drug might never be available, a new study has found.
That’s the conclusion of a new report whose authors say the situation raises ethical concerns. More than a third of the published trials performed under 1997 legislation called the Pediatric Exclusivity Provision were carried out at least partly in developing or transitioning nations, such as Uganda and India, researchers found.
M Nabeel Ghayur, a pharmacologist who worked in drug development in Pakistan before joining McMaster University in Hamilton, Ontario, Canada, said conditions are similar in India and Pakistan.
“People actually have blind trust in their doctor in South Asia. They have no idea what drug development is, they have no idea what clinical trials are,” he said.
The Duke Clinical Research Institute study found that
majority of the paediatric trials enrolled patients in at
least one country outside the US.
While more than one-third of trials included patients in
developing or transitioning countries, 11 per cent were
conducted exclusively outside the US.
The study, published in the journal Pediatrics, raised
ethical concerns such as whether the trials in those nations
were being conducted in sync with the health need of the local
population and whether the treatments studied would be readily
available to children there after the end of the trial.
"There are potential benefits to the globalisation of
paediatric research, such as reducing the cost and time line
for drug development, fostering global clinical innovation,
and improving access to therapies and the health of children
worldwide," said Sara Pasquali, the study`s lead author and
assistant professor of pediatrics at Duke.
"However, globalisation also raises certain ethical and
scientific concerns," she said, referring to how drug
manufacturers have been taking advantage of the Congressional
provision called The Pediatric Exclusivity Provision.
The provision provides six months of patent extension to
pharmaceutical companies to conduct safety and efficacy
studies of drugs in children.
But this programme has resulted in drugmakers netting an
estimated USD 14 billion in profits, the researchers found.
"The original objective of the programme was to encourage
research that enables the FDA to label drugs for appropriate
use in children in the US," said Pasquali.
"Whether it`s valid to extrapolate the results from
trials conducted in other countries is not known. The efficacy
of a medication may depend on genetic background and access to
health care resources, among other factors, which may differ
The research team, which analysed 174 trials, found that
about half of the studies conducted under this programme are
not published, so the analysis may underestimate the
globalisation of paediatric trials.
The trials included sites in 54 countries, including
developing or transitioning countries in Eastern Europe, Asia,
Africa, and South and Central America.
Pasquali said the drugmakers chose poor and developing
countries for carrying out trials as they involve less cost
and fewer regulatory requirements compared to those in the US.
"It`s much cheaper, easier, and less time consuming to
conduct research outside the US," Pasquali said.
The authors also expressed concern for how children and
families in the developing world may have been induced to
participate in trials.
They noted that participation in the study may be the
only access a family has to medical care and compensation for
trial participation can be significant.
Ensuring adequate informed consent may also be difficult
in countries with widespread illiteracy, they said, suggesting
that drugmakers should describe how appropriate a drug would
be for the country in which it is to be tested.