Dear readers,
The Question of un/ethical medical trials is raised time & again, some
time back on e-drug forum a investigative journalist Sonia Shah talked
about her book "The Body Hunters: testing new drugs on the worlds
poorest patients', related to issue of medical trials.
This is just one book I can recommend for reading on in-depth of the issue.
I have a few viewpoints on this issue, would welcome as the discussion,
facts & shearing of experiences goes on this forum.
Clinical trials should be allowed (or accepted) from countries/states,
where certain indicators such as complies:
* the population already having good access to basic health care
* Level of governance in managing & monitoring health services from
different actors such as government & private sectors is high.
* Coverage & implementation of rational usage of drugs,
standardization of clinical practices, past record of
accomplishment of availability of listed drugs under the essential
drugs.
* Primary education rate of the country / state should be not less
then 70 %.
* (Quality) medical record stata, reporting system from every level
of health services.
* Countries record of accomplishment of (speedy & transparent)
settlements for medical malpractices / medical negligence / clams.
* policy & quality of re habitation in every sphere of society.
* empowerment of “pharmaceutical care” at grass root.
* Infrastructure & human resources available to the county / state
undertaking clinical trials, without compromising the
requirements of population’s basic health care.
The lobbing & advocacy should undergo globally for identification of
potential states as ‘authorized site’, where ethical clinical trials
should be conducted.
With regards
S.S.KAMBOJ
Awaaz Foundation
(Pharmacist)
pharmacist_in@yahoo.com
E-DRUG: Clinical trials and ethics (2)
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While it is difficult at a theoretical level to disagree with
Pharmacist S.S.KAMBOJ's proposed rules, at a practical level, how many
developing countries with a high burden of neglected conditions could
comply? Are we not taking the risk that it becomes almost impossible,
for example, to hold clinical trials on new TB drugs (particularly for
MDR/XDR TB) or for prevention of mother-to-child transmission of HIV?
I'm sure there are a host of other neglected conditions which would be
similar.
Should we not be aiming to find ways of enforcing existing rules or
developing appropriate new ones that allow clinical trials to take
place in the developing world? I accept that there is concern over dual
standards in this field, but we accept (or perhaps turn a blind eye to)
the dual standards over many aspects of health care, including access
to affordable treatment for neglected diseases. I'd hate to see these
rules continuing to be put forward as justification for lack of action.
Chris
--
Chris W. Green (chrisg@spiritia.or.id)
Training & Information, Spiritia Foundation
Jakarta, Indonesia
Tel: +62 (21) 422-5163 Fax: +62 (21) 4287 1866
Web site: <http://spiritia.or.id>
Blog: Adventures with HIV in Indonesia
<http://indohiv.blogspot.com/>
E-DRUG: Clinical trials and ethics (3)
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It seems to me that this would exclude many poor countries from potential
benefit unnecessarily. After all, cures for tropical diseases are best tested in tropical countries where disease is prevalent.
It seems to me that what is unethical is doing trials in poor countries
because they would not be ethically acceptable in rich ones.
My criterion would be passing ethical standards set up in countries that DO
have all the excellent criteria you specify. Does WHO have a role?
Should drug companies then apply for oversight by independent organisation
such as WHO.
Best
Diana
Professor Diana Kornbrot
email: d.e.kornbrot@herts.ac.uk
web: http://web.mac.com/kornbrot/iweb/KornbrotHome.html
Work
School of Psychology
University of Hertfordshire
College Lane, Hatfield, Hertfordshire AL10 9AB, UK
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E-DRUG: Clinical trials and ethics (4)
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I think that we need to face the problem of unethical practices in clinical trials in developing countries head on instead of banning clinical trials outright. There a lot of benefits that accrue from conducting trials in these countries (health, economic and infrastructural) that actually contribute positively to the communities involved.
More so, where do we then conduct clinical trials for drugs that are used to treat conditions occurring only in Africa for example? It is obvious that all stakeholders need to work together to promote ethical conduct of clinical trials in our countries!
Joseph Fadare MD
Physician/Clinical Pharmacologist
Nigeria
dokita007@yahoo.com
E-DRUG: Clinical trials and ethics (5)
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Clinical trials and ethics is not a question of just developing or the least developed countries. I have seen comprehensive guidelines addressing issues of clinical trials and ethics even in developed countries were these problems have persisted even today. For instance the Canadian Institute of Health Research (CIHR) has developed guidelines for Health Research involving Aboriginal People in Canada. These are useful tools of course with the presumption that researchers will respect the provisions in them.
One of the biggest challenges in developing countries has been non-functioning of systems including national centers that make clearance for health research. I would thus think that as we develop laws and guidelines on clinical trials and medial ethics, we need to strengthen the roles of National Councils that are mandated to clear this kind of research other wise even the good laws, regulations and guidelines can remain a sump into which endless amounts of energy will be suck, with not much to show for them.
Mulumba, Moses
Health Rights Lawyer (Uganda)
mulumba_mos@yahoo.co.uk
E-DRUG: Clinical trials and ethics (6)
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Friends,
A lot of the medical research that goes on in developing countries has been approved by Institutional Review Boards (IRBs) in developed countries. During the life of the project, these IRBs have continuing responsibility to protect research participants and to recognize and report unusual adverse events that may be due to procedures that are part of the study. As I understand the rules, this responsibility commonly extends to particpants in other countries, where the research is conducted.
The risk of adverse events from trial procedures occurs not only in trials funded by private drug companies, but also with research funded by foreign governments and foundations.
For example, the recent trial of circumcision to protect men from sexual acquisition of HIV in Kisumu, Kenya, observed 4 men with incident HIV infections within a month after circumcision. Three of the men reported no sexual activity in that month. The project was funded by governments of Canada and the US. IRBs in Canadian and US universities (as well as in Kenya) were responsible for the safety of participants. I have seen no indication that researchers, IRBs, or funders have considered that these infections are adverse events that should be investigated to see if they can be traced to infection control during circumcisions.
On the face of it, it would appear that any of the 4 men with early infections has a plausible case to challenge US and Canadian IRBs and government agencies for failure to follow their own rules to protect participants. Hopefully, someone will respond, and will arrange for an investigation to see if these infections can be traced to infection control lapses during circumcision.
Best regards,
David
David Gisselquist
david_gisselquist@yahoo.com
E-DRUG: Clinical trials and ethics (8)
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Dear All,
Am involved in a retrospective study of clinical trials and ethics covering Nigeria, Ghana, Cameroun and Malawi. If you were part of such trials or you were a trial subject kindly contact the following
Kristin Peterson <kris@uci.edu>,
Morenike Ukpong <toyinukpong@yahoo.co.uk>
Olatubosun Obileye obileyet@gmail.com
Thank you
Olatubosun Obileye