La FDA descarta a Helsinki como standard ético en investigación…

…y solo exige que se cumpla con las GCP!

Ver: Integrity in Science Watch Week of 05/05/2008 en

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.

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.

Es de gran importancia para los Comités de Ética en Investigación de América Latina insistir en la protección de las personas en investigación a partir de la Declaración de Helsinki. El hecho de que la FDA (un organismo estadounidense bastante inefectivo para proteger a sus ciudadanos) no exija su cumplimiento es un buen indicio para reforzar la exigencia en nuestra región.




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