On April 21, 2014 this headline appeared in the Times of India: “Row over clinical trial as 254 women die”. The newspaper claims that the women in several US funded
trials on the prevention of cervical cancer died because they were part of a
control group of 140,000 women that did not receive any screening method.
According to the critics the trials were unethical because the women in the
control group should have received one of the available, proven effective
cancer screening methods. Denying them access caused the unnecessary deaths. One
of the critics, writing in the Indian
Journal of Medical Ethics, pointed out that “these studies would not have
been permitted in the country of the funding organizations (US National Cancer
Institute and the Bill and Melinda Gates Foundation”.
In parallel, a US physician, Eric Suba, filed a complaint
with the US Office of Human Research Protection (OHRP), charging that these
trials were unethical because they did not provide any effective screening in
the control groups. OHRP did not find any violation of the US regulations in
the design of the studies (which was the basis for the criticism). However,
they did conclude that the informed consent form in one of the trials was
defective. The form did not adequately inform the participants about
alternatives for screening outside of the clinical trial. The English version
of the informed consent form did contain language that effective screening was
available in clinics and the women could avail themselves of this opportunity.
The translated local version did not contain this information.
The Indian Journal of
Medical Ethics has carried a number of critical articles about these trials
over the years. A respected bioethicist, Ruth Macklin, has strongly supported
their arguments in the same journal. The EU funded and endorsed project on
“Ethics dumping” has flagged these trials as typical examples of unethical
practice. So how can this be? Trials funded by major organizations, endorsed by
respected scientists in India, approved by Ethics Review Committees in India,
reviewed by the main regulatory body in the US without any comments on the
design, have nevertheless been criticized by the main bioethics journal in
India, respected international bioethicists, and by a project endorsed and funded
by the European Commission. Also, international organizations such as WHO have
endorsed the trials as providing important results directly relevant for
policies in low- and middle-income countries. It is clearly important to be
clear about which version is true: Should these trials never have started? Or
did they provide knowledge essential for public policy and not procurable by
any other design? I will examine these questions in several posts of the next few weeks.
