Jakarta Globe - AFP, Abhaya
Srivastava, July 7, 2013
 |
| Indian heart patient Niranjan Lal Pathak poses at his residence in Indore on September 23, 2012. (AFP Photo) |
New Delhi.
Niranjan Lal Pathak couldn’t believe his luck initially. When a doctor at a
hospital in central India offered the factory watchman free treatment for a
heart complaint, he jumped at the chance.
It was five
years ago and the family of the 72-year-old says he didn’t realize that the
Maharaja Yashwantrao Hospital in the city of Indore was about to enroll him in
a trial of an untested drug.
“We were
told that our uncle will be treated under a special project,” his nephew Alok
Pathak told AFP over the phone from Indore, the largest city of Madhya Pradesh
state.
“The doctor
said we wouldn’t have to spend a penny. There was only one condition placed
before us — that we should not approach
local chemists if we ever ran out of his medicines but go straight to the
doctor,” he said.
A petition
filed by the family in India’s Supreme Court alleges that the drug tested on
him was Atopaxar, developed by Japan-based pharmaceutical company Eisai and
supposed to treat anxiety disorders.
His family
and health rights group Swasthya Adhikaar Manch (Health Rights Platform) say
that he would never have enrolled for the trial had he known that an untested
drug would be administered.
The family
also claims that the side-effects of the drug left Pathak suffering from
dementia.
“He barely
recognizes us. His life is finished and so are our hopes to see him healthy and
happy again,” Alok told AFP, his voice choked with emotion.
Many
desperate and poor people in India are unwittingly taking part in clinical
trials for drugs by Indian and multinational pharmaceutical companies that
outsource the work to unregulated research organisations.
The record
of Pathak’s treatment was maintained on a medical card and his family is now
fighting a legal battle, one of scores of cases brought by people who say they
are victims of illegal trials.
A booming
business
Testing
pharmaceuticals on humans is a mandatory and expensive step for drug companies
who must prove to regulatory authorities that treatments have no dangerous
side-effects in order to bring them to market.
The
Confederation of Indian Industry estimates that companies save up to 60 percent
by undertaking the different phases of testing a new drug in India as compared
to developed countries.
The
clinical research market in India grew by 12.1 percent in 2010-11 with revenues
of $485 million, according to report by Frost and Sullivan, a global business
research and consulting firm.
The study,
released in July last year, projected the industry to reach the one-billion
dollar mark by the end of 2016.
But the
legal case in the Supreme Court, which began in February last year, has helped
to bring to light many of the alleged misdeeds by doctors in connivance with
pharmaceutical companies.
“There has
to be some sense of responsibility. Human beings are treated like guinea pigs,”
Supreme Court judges R.M. Lodha and A.S. Dave said last year in a written
statement.
In Pathak’s
case, the hospital says the doctor who treated him administered the drug
without authorization and had since left the institution, while Eisai declined
to comment, saying it was unable to respond to inquiries on individuals.
“Eisai is
committed to making a meaningful contribution under any healthcare system and
undertaking all of its activities adhering to the highest legal and ethical
standards,” it said in an email to AFP.
Lax
regulation exploited
Health
campaigner Amulya Nidhi says the lack of strict regulations has prompted many
pharmaceutical companies to look to India and other developing countries for
the tests.
“In Europe
and the United States the laws are pretty strict. India, on the other hand,
makes for a less restrictive destination for drug trials because the regulator
lacks teeth,” said Nidhi, who works for the Swasthya Adhikaar Manch group.
Swasthya
Adhikaar Manch, which is fighting on behalf of some of the trial victims, says
most of them visited hospitals for routine treatment but were subjected to
trials without their “informed consent”.
“In almost
all the cases there is no genuine informed consent,” said campaigner Nidhi.
“The label
on the medicines often does not specify that it is meant for trial, and
vulnerable people end up being used as lab rats,” he said, showing one such
drug sample to AFP in New Delhi.
Faced with
widespread criticism, the government is amending the old Drugs and Cosmetics
Act in order to fix greater responsibility on companies and ethics committees
which are supposed to oversee the trials, although no timeframe for completion
has been given.
As per the
law, the subject of a trial or his family must be given copies of the patient
information sheet, consent form and a clinical trial liability insurance
policy.
Sonia Shah,
author of “The Body Hunters: Testing New Drugs on the World’s Poorest
Patients,” says it is imperative to find a way to balance the need for research
with the full protection of patients.
“Under-financed
hospitals and clinics gain expertise, funding, and often new equipment when
they conduct clinical trials. Patients who lack access to regular care can get
treatments otherwise not available to them,” she told AFP.
“The
question is whether these benefits are in keeping with the health priorities of
the country and whether they outweigh the risks,” she added.
The Indian
state of Madhya Pradesh, home to the Pathaks, has been at the center of the
trial scandal since 2004 when doctors were accused of using victims of the 1984
Bhopal gas disaster for trials without their consent.
The
non-profit Bhopal Group for Information and Action, which fights for the rights
of thousands left disabled by the world’s worst industrial disaster, said that
14 people died as a result of these trials.
The state
was once again under the spotlight last year when a fine of just 5,000 rupees
($92) was slapped on 12 doctors found to have conducted illegal trials on
children and the mentally disabled.
Agence France-Presse
No comments:
Post a Comment