E-DRUG: trials with expensive drugs in developing countries are unethical
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[From Western Journal of Medicine; copied as fair use. NN]
www.ewjm.com/cgi/reprint/174/5/302
WESTERN JOURNAL OF MEDICINE
Trials of expensive drugs on peoples of poor nations are totally unethical
and must be stopped
[The cost to global health of drug company profits 2001; 174: 302-3]
Trials of expensive drugs carried out on peoples of poor nations serve only
to swell the already bulging coffers of the US pharmaceutical industry, and
must be stopped, says an editorial in the Western Journal of Medicine.
The US pharmaceutical industry, which makes more than twice the US average
profit, looks to the developing world as a cheap option, write Drs Gavin
Yamey, deputy editor of WJM, and Rhona MacDonald, assistant editor of the
BMJ. Fewer regulatory controls make for cheaper trials, they say, and cite
Eli Lilly's expected enrolment of 7309 people in poor countries for trials
this year compared with 590 in 1994.
Local improvements in health care stop once the trials are completed, and
the drugs are often for conditions that largely affect industrialized or
developed nations. But even when they are not, the prices charged put them
way beyond the reach of most of the countries in which they are tested,
say the authors.
Drugs that are effective against conditions common in the developing world
do not have to be marketed if they don't reap the required financial
rewards, write the authors. They cite the example of eflornithine,
originally developed as an anticancer agent, but found to be much more
effective against sleeping sickness, a disease that affects up to 20 per
cent of the population in Uganda. Hoechst Marion Roussel, the
manufacturers, stopped its production in 1999, citing commercial failure
as the reason.
"Would the US government stand by and allow a drug company to refuse to
market a safe treatment for a disease that killed thousands of US citizens
every year? We doubt it," write the authors.
The authors also question the pharmaceutical industry's refusal to allow
generic drug manufacture in poor countries. The industry's practice must
be brought to heel, they say, and it must be forced to follow ethical
standards for drug trials in line with the revised Declaration of
Helsinki, as well as improve access to medicines in the developing world.
The authors conclude: "The pharmaceutical's continued free reign in an
unfettered free market is unacceptable?. The only freedom that the free
market is currently offering to those in poor countries is the freedom to
die without treatment."
Contacts:
Dr Rhona MacDonald assistant editor, British Medical Journal, London.
Tel: +44 (0) 207 383 6150
Email: rmacdonald@bmj.com
Before May 21, Catherine Nancarrow, managing editor, WJM, San Francisco,
California.
Tel: 415 974 5977
Email:cnancarrow@ewjm.com
After May 21, Dr Gavin Yamey : gyamey@ewjm.com
[submitted via Pharm-Policy by:]
Prof Udo Schuklenk, PhD
Head of Bioethics | Co-Editor BIOETHICS
University of the Witwatersrand
Faculty of Health Sciences
7 York Rd., Parktown 2193
Johannesburg, South Africa
Tel +27 11 717 2718 | Fax +27 11 643 1264
web: www.wits.ac.za/bioethics
personal web: www.udo-schuklenk.org
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