U.S. pharmaceutical companies have moved their operations overseas in
the past decade, testing their drugs on poor people in such lands as
Russia, China, Brazil and Romania.
It is a $30 billion business, and
today around 105 countries are allowing such large corporations as Merck
and AstraZeneca to conduct clinical trials on their soil.
One country that has experienced a boom like
no other in this industry is India, with its widely spoken English, an
established medical infrastructure and welcoming attitudes towards
foreign industry.
Most importantly, these pharmaceutical companies are
exploiting the country’s vast number of illiterate and poor people who
are willing to become guinea pigs.
Zeina Awad, a reporter for Al Jazeera’s “Fault
Lines” program, traveled to India to investigate clinical research
being conducted there.
She explored what role the United States
regulatory agencies are playing in overseeing the clinical trials, and
whether the testing complies with international ethical standards.
Her report, “Outsourced: Clinical Trials Overseas,” aired on Al Jazeera English recently.
New America Media Health Editor Viji Sundaram interviewed Awad about what she found.
Viji Sundaram: Your report seems to suggest
that a combination of poverty and inadequate public health care is what
drives many Indians to enroll in clinical drug trials as guinea pigs. Do
they actually know what they are getting into?
Zeina Awad: The growth of the clinical-trial
industry in India needs to be seen within the social and economic
context of the country. According to the United Nations, 40 percent of
people in India are illiterate. The gap between rich and poor continues
to grow. Many risk not knowing whether the treatment their doctor is
prescribing is [a proven] treatment or a part of a clinical trial. That
aside, it’s also important to remember that in certain societies – and
India is one of them – doctors are respected to the point of being
revered. Their word is rarely questioned, so the likelihood of a person
questioning their doctor about specific treatments is low.
Economics plays a role in a person’s
decision-making. We met a young man in the impoverished community of
Dharavi (Asia’s largest slum) in Mumbai, who told us that he enrolls in
clinical trials as a way to make a living because he makes more money
that way then when he works as a laborer. He also told us that he has
many friends who do the same.
Most of them don’t tell their families
because there is some shame associated with doing this.
Sundaram: You report that some U.S.
pharmaceutical companies chose patients for their tests at a hospital in
Bhopal that was built as a memorial to the 1984 victims of the Union
Carbide gas leak. Satinath Sarangi, the activist who is working to get
justice for the survivors and one of the people you interviewed, said
that 100 Bhopal survivors in six trials enabled the hospital to earn a
whopping $220,000. How long were trials allowed to go on there?
Awad: Yes, it is ironic -- and sad. The
hospital in Bhopal was built by Union Carbide as part of their
compensation for the victims of the 1984 gas-leak disaster. But after
the scandal about drug testing on the gas leak survivors broke last
year, the government took over and banned all testing.
The drug trials ran from 2004 until 2008. The
complete lack of empathy of both the doctors we secretly recorded stood
out to me. In addition to what one of them says in our film, he also
told us he believes the reason why his hospital has been singled out was
because others were “jealous” of the hospital’s performance. Some of
the pharmaceutical companies and CROs [Clinical Research Organizations]
who ran the trials refused to speak to us. Meanwhile, people who are
almost always poor and often illiterate fell by the wayside.
Sundaram: Explain the nexus that seems to
exist between CROs and hospitals. How do these CROs pick the hospitals
where they want to test drugs? Did your investigation reveal any
particular doctors who benefited from this testing?
Awad: CROs are profit-driven companies that
specialize in running clinical trials. Their clients are hospitals and
pharmaceutical companies. CROs and the Association of Clinical Research
Organizations, (the body that represents a number of CROs,) say that
hospitals are chosen based on their performance, resources,
professionalism and whether or not they have the technology necessary
for clinical trials.
Sundaram: One family you interviewed in Andhra
Pradesh lost two daughters after they were vaccinated with Merck’s
Gardasil, one of the vaccines that is used in the United States to
prevent contracting the Human Papillomavirus, which causes genital warts
and cervical cancer. A few other girls also died after they were
vaccinated with Gardasil. Were there any health care professionals you
interviewed, who said they believed that the deaths were or could be
related to Gardasil? Is any action going to be taken against the
principal of that school, who gave consent to the CRO to vaccinate his
students? How many students in all were vaccinated with Gardasil?
Awad: There is no evidence linking Gardasil
vaccine to the deaths. There was also no adequate follow up with the
girls’ families, and with no follow up there is no way of knowing what
went wrong. The government did issue a report in which it concluded that
none of the girls died from the vaccine.
We looked at the girls who were vaccinated
while they were at school in India’s tribal region.
It was the school’s
headmaster, and not the families of the girls, who gave consent for the
girls to participate in the vaccination program. The headmaster is no
longer working at that school, and he has not been prosecuted. In fact,
the government’s investigation found that there is no one party
responsible for any wrongdoing, and therefore no one was to be
prosecuted.
Sundaram: But why would Merck want to test a
drug that has been already approved by the U.S. Food and Drug
Administration on more people in another country?
Awad: PATH (a nonprofit whose stated goal is
to improve global health and well-being) wanted to see which of two
vaccines, Merck’s Gardasil and GlaxoSmithKline’s Ceravix, yielded better
results within certain populations. PATH says it wanted to get large
volumes of the better-performing vaccine at a lower affordable price to a
number of countries, including India. PATH was not testing Gardasil for
FDA approval or for a U.S. market.
Sundaram: Did you ask Merck if they had to pay fines to families of women vaccinated with Gardasil in any part of the world?
Awad: Merck did not want to clarify to “Fault
Lines” the terms under which it provided PATH with the medication. We
did not ask them if they had to pay fines in other parts of the world,
but we did not come across a case where they paid out.
Sundaram: When did the U.S. Department of
Justice (DOJ) begin its industry-wide corruption investigation into
overseas clinical trials? Were you able to find out if any Indian
officials had been bribed to allow the clinical trials to be done there?
Awad: The U.S. Department of Justice launched
its investigation in the summer of 2010. In India, many health workers
(doctors, nurses, etcetera) and health officials work for state-run
hospitals and government agencies, which makes them government
employees. Bribing them to advance business interests violates U.S.
antibribery laws.
During the course of our reporting, one doctor
told us when the camera was not rolling that he taken his family to the
United States on trips funded by the CRO and pharma companies.
Another
doctor said – on the record – that he witnessed how pharmaceutical
companies have offered some of his colleagues kickbacks and all-expenses
paid trips to the U.S. and other Western countries.
The DOJ is
investigating whether such perks are being used to advance business
interests.
Sundaram: Dr. Sidney Wolfe, health research
director with the U.S.-based nonprofit, Public Citizen, told you that
ethical oversight of clinical trials in foreign lands is less than it is
in the United States, which makes it easy for CROs to exploit the poor
and illiterate. You interviewed families in India on whom clinical
trials were conducted, who told you they were illiterate and didn’t know
what they were signing. Is there an oversight agency in India to ensure
that those who sign consent forms know what they are signing?
Awad: In India, as in other countries in the
world, clinical trials are supposed to be conducted following
internationally agreed upon norms and ethics. These include informed
consent, follow-up care and the practice of testing drugs on populations
that stand to benefit from any breakthrough results.
During our research and reporting, we found
evidence that all three have not always been properly adhered to. Also,
by law, every hospital that runs a clinical trial is supposed to have an
independent committee that oversees the trial. We heard anecdotal
accounts that that does not always happen. In some cases, the people
running the clinical trials have their own friends and family members
sit on the independent committees.