[Ip-health] FDA Scraps Helsinki Declaration on Protecting Human Subjects

[Joana Ramos]

http://www.cspinet.org/integrity/watch/index.html

Integrity in Science Watch Week of 05/05/2008

 FDA Scraps Helsinki Declaration on Protecting Human Subjects

Drug companies got a green light last week to start using data from
foreign clinical trials in new drug applications even if the trials only
compare new products to placebos instead of best available treatments.
The change marks a sharp departure from the 1989 Declaration of Helsinki
protecting human subjects in clinical research, the Food and Drug
Administration's previous standard. The new rule, which goes into effect
next October, was pushed by drug and device manufacturers, but opposed
by numerous public interest, patient advocacy, and consumer groups. The
Declaration of Helsinki "is the standard-bearer for international
research ethics and enjoys particular respect in the developing world,"
said Peter Lurie, deputy director of Public Citizen's Health Research
Group. Its rejection is "in line with other U.S. efforts to flout
international mores."

The new rule's substitute standard says foreign trials should follow
good clinical practices (GCP) and include a review and approval by an
independent ethics committee. A major difference between the Helsinki
Declaration and GCP is the former's insistence on using existing
treatments instead of placebos if they are available. The Helsinki
Declaration had the effect of extending existing treatments to people in
poor countries if they participated in clinical trials.

The change is likely to push more clinical trials abroad, where an
estimated 35 percent of all trials submitted to the FDA in new drug
applications now take place. Unlike trials conducted in the U.S.,
companies do not have to submit an investigative new drug application
(IND) to the FDA before beginning research in foreign countries. The FDA
estimates about 575 of the foreign trials submitted to the agency each
year as part of new drug applications do not go through the IND process.
The FDA rejected the notion that adopting the self-regulating GCP
standard and eliminating references to the Helsinki Declaration "will
hurt subjects in developing countries or result in less protection for
subjects in foreign studies." GCP requires trial sponsors closely
monitor trial behavior and report adverse events, the agency noted.

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Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org