Dear Friends:
Today The Independentt (16 11 2011) publishes the third instalment of
their investigative reports on drugs trial after the Bhopal tragedy.
Government admit that their regulation is weak. Congratulations are in
order to Andrew Buncombe and Nina Lekhani; and also the Editor of the
paper who too wrote on the subject.
-bhuban
Indian authorities have claimed they plan to tighten regulations over
the way medical trials are conducted in the country and address some of
the concerns highlighted in The Independent's investigation.
As campaigners in India and around the world repeated their call for
better oversight, official sources admitted that weak regulation was a
problem that needed to be tackled by the Drug Controller General of
India (DGCI), the body charged with overseeing and regulating trials.
Last week, Dr V G Somani was appointed to head the body, which is part
of the Ministry of Health and Family Welfare. The Health Minister
Ghulam Nabi Azad failed to respond to inquiries.
A source within the drugs control department said its priorities would
be the establishment of clearer guidelines – especially for dealing
with adverse reactions to drugs taken during a trial – a focus on
affordable medicine for India, and the development of research and
development. "I don't think you can say the oversight was a failure.
But it was weak oversight," said the source, who asked not be
identified given the sensitivity of the issue.
In regard to ethical committees, the supposedly independent bodies that
oversee and monitor trials, the source added: "The committees have to
be made more accountable, by law." But the source said the committees'
ability to oversee was limited. "They cannot inspect every day," the
source added.
Sandhya Srinivasan, executive editor of the Indian Journal of Medical
Ethics, said there was a pressing need for more effective oversight,
given the abuses that have come to her attention. "In theory much of it
can be addressed by regulation," she said. "Another larger concern is
that effective, life-saving drugs tested in India are not available in
India at anywhere near an affordable price."
Dr Anand Rai, a physician turned whistle-blower from Indore, where he
exposed trials that a police inquiry said breached ethical guidelines,
also said it was important the authorities focused on the trials of
drugs designed to tackle diseases that are common in India, such as
malaria and dengue. He also called for better regulation of ethical
committees.
Brinda Karat, an opposition MP who has led calls for better oversight,
said changes made to legislation that loosened regulations "must be
reviewed in the light of the experience of the last six years. Also,
the pending bill on regulation must be placed before the parliament".
She added: "Strong action [must be taken] on the cases you have written
about."
Some say there must be a complete overhaul. Dr Chandra Gulhati, editor
of the Monthly Index of Medical Specialties and the man who has
collated much of the data regarding drug trials in India, said many
believed the changes made in 2005 had helped foreign drug companies by
reducing costs and providing easy access to trial subjects, but had
provided little benefit to India.
"What does India get as a nation?" he said. "I believe the issue is not
of tightening the rules but revisiting the entire process of
unconditional liberalisation. When India permits British Airways to
start a service to India, Indian carriers in return get the same
facility. This is reciprocal. In the drug field there is just one-way
traffic."
Europe: MEPs target companies using 'guinea pigs' overseas
An influential group of MEPs have vowed to stamp out unethical clinical
trials by forcing European regulators to take more robust action
against drug companies guilty of violations.
The MEPs are urging a key European committee to hold emergency
discussions amid growing evidence of ethical abuses in developing
countries. The European Medicines Authority (EMA) has been accused of
failing to enforce existing laws that stipulate only drugs tested
ethically, to international standards, should be licensed in Europe.
The EMA, responsible for approving new drugs in Europe, told The
Independent that the globalisation of clinical trials posed a "huge
challenge" that needed more resources and better cooperation from the
pharmaceutical industry.
Dr Peter Liese, German Christian Democratic MEP, said rejecting just
one unethically tested drug from the European market would serve as a
"powerful message" to the whole industry. "We have a big problem and we
need to do better," he said. "But it is not a question of new laws, it
is about implementing existing ones."
Margrete Auken, Danish Green Party MEP, said Europe must treat
unethical clinical trials with the same gravity as organ trafficking
and called for companies to be "named and shamed".
There are almost 120,000 clinical trials currently taking pace in 178
countries. But only 36 of those countries have effective drug
regulators, including just one in Africa, one in Latin America and
three in Asia. This means Western regulators, including the EMA and the
US Food and Drug Administration, know that huge numbers of clinical
trials are taking place without adequate supervision. The EMA has never
rejected a new drug solely on the basis of ethical violations.
Critics say that the watchdog's current approach is inadequate. "The
EMA must start asking drug companies for information about how they
safeguarded the safety of participants before they grant
authorisation," Annelies den Boer, of the Dutch health NGO Wemos, said.
"Europe is the second-largest drug market in the world, so we need to
send a strong signal to companies that they cannot get away with it."
Dr Amit Sengupta, from Health Action International, said: "The
[Western] regulators are becoming wary about poorly regulated countries
not because of the unethical practices, but because they are worried
about quality of the data which could harm their own patients."
In the UK, Lord Leslie Turnberg, former NHS doctor and chair of the All
Party Parliamentary Group on Medical Research, said he would consider
investigating the issues raised by The Independent. British and US
lawyers are also considering the evidence to determine whether civil
cases can be brought.
Nina Lakhani
Polio vaccine: An ethical dilemma
A new vaccine tested in Indore has emerged as a key tool in India's
battle against polio. And in the process it has shown how complex the
questions over ethical drug trials are bound to be.
Some of the research on the medication was carried out at the Maharaja
Yashwantrao hospital in Indore, the same one that has had new trials
suspended amid allegations that a small group of doctors conducted
trials in breach of regulations. (The doctors and the hospital deny the
charges.) The vaccine is important because it can immunise children
against two key strains of the virus in a single dose. The long-running
struggle to eliminate polio in India is looking better than it ever
has: last month officials said there had been only one reported case
this year.
Dr Hemant Jain, a US-trained paediatrician who was involved in testing
the vaccine and who denied there had been a breach of guidelines,
claimed the controversy had put back drug trials in India by 10 years.
"The WHO came to us with a request to test a new vaccine. Credit has
been given to this new vaccine and 75 per cent of the work was done in
Indore," he said.
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