Correspondence

Research in Developing Countries

N Engl J Med 2002; 346:627-628February 21, 2002

Article

To the Editor:

Shapiro and Meslin1 and Koski and Nightingale2 (July 12 issue) discuss the ethical problems that occur when developed countries sponsor clinical trials in developing countries. Many of the ethical problems arise because developing countries are poor and cannot afford the treatments that are used in developed countries. An important ethical issue is therefore the amount of economic aid given by rich countries to poor countries.

The total amount of aid given to developing countries has decreased substantially over the past 10 years. The United States, in particular, now gives a much lower proportion of the gross domestic product (GDP) than any other country that belongs to the Organization for Economic Cooperation and Development (OECD) (and my country, Australia, also gives less than the average amount). Table 1Table 1Overseas-Development Aid in 1999. shows the amount of aid given by each OECD country, with the least generous nations at the bottom of the table.3 The target for overseas-development aid that has been established by the United Nations is 0.7 percent of the GDP; only Denmark, Norway, the Netherlands, and Sweden meet or exceed this amount.

Perhaps doctors in developed countries could do more to persuade their governments to help developing countries. This would reduce the large disparity in wealth that is the root cause of the ethical problems that arise when clinical trials sponsored by developed countries are conducted in developing countries.

Frank Shann, M.B., M.D.
Royal Children's Hospital, Melbourne, VIC 3052, Australia
shannf@cryptic.rch.unimelb.edu.au

3 References

1. 1

   Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med 2001;345:139-142
   Full Text | Web of Science | Medline

2. 2

   Koski G, Nightingale SL. Research involving human subjects in developing countries. N Engl J Med 2001;345:136-138
   Full Text | Web of Science | Medline

3. 3

   Important DAC statistical tables and charts: table: total ODA flows in 1998 and 1999. Paris: Organization for Economic Cooperation and Development. (Accessed February 4, 2002, at http://www.oecd.org/dac/htm/dacstats.htm#dactables.)
   

To the Editor:

As chairman of the investigational review board at my institution, I believe the use of a placebo by a U.S. organization administering a clinical trial in a developing country, when the same study performed here would demand a therapeutic control, should be viewed with skepticism. Use of placebo on the grounds that one cannot determine the best alternative to the treatment under investigation or, worse, on the grounds that such use is consistent with the local standard of care — no therapy — is potentially inhumane, even if people are no worse off at the end of the study than they would have been if they had not participated in it.

Conducting a placebo-controlled trial when there is a reasonable therapeutic alternative to the treatment under investigation is most likely to be motivated by financial considerations. In the United States, we have categorically rejected the notion of children working in sweatshops to make clothing. How can we accept the possibility of using drugs that have been tested in trials in underdeveloped countries in which patients in control groups may have suffered or died because they received placebo instead of active treatment?

Steven D. Schwaitzberg, M.D.
New England Medical Center, Boston, MA 02021
sschwaitzberg@lifespan.org