Standing Up for Preclinical Tests


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busted glassOn September 20, Bruce Alberts and ten other eminent scientists published an editorial in Science, titled “Standing Up for GMOs” after a field trial of Golden Rice was destroyed by vandals at the Philippine Rice Research Institute August 8.

Rice is a major dietary staple for almost half of humanity, but common rice lacks Vitamin A. Ingo Potrikus and Peter Beyer developed by genetic engineering a rice variety with grains that accumulate beta carotene. It took them more than a decade to develop this strain, and a few ounces of this cooked rice provide enough beta carotene to eliminate the morbidity and mortality of Vitamin A deficiency that causes blindness in children and adults.

While this was accomplished scientifically more than a decade ago, Golden Rice is not yet available to resource-poor farmers. Getting it to them will take longer now, thanks to the vandalized field trial. It’s deplorable for those who disagree with technologies developed on top of sound science to simply take the law in their hands. Vandalism has happened elsewhere: in Brazil, the Instituto Royal in São Paulo was invaded, and close to 200 beagles intended for preclinical testing were stolen. Those preclinical tests are followed, of course, by several phases of clinical tests in humans, and all marketed drugs today had to go thru preclinical tests before approval. So the question is, Is the Instituto Royal performing pre-clinical tests with rodents and beagles somehow at the margin of Brazilian law?

Absolutely not. The Institute follows all the requirements of The National Council to Control The Experimentation with Animals (CONCEA), created by Law 11794 on October 8, 2008, satisfying Article 255 of the Brazilian constitution. The law requires any institution performing experiments for teaching or scientific purposes with animals must establish a CEUA (Ethical Commission for Animal Use), which includes a representative of the Animal Protection Society. Instituto Royal is the highest preclinical institution operating in Brazil over the past decade. Most drugs registered at The Agency for Health Vigilance (ANVISA , equivalent to US’s FDA) are the result of preclinical tests performed at the Institute.

At the Instituto Royal break in, laboratories containing no animals were entirely destroyed, costing millions of dollars in damage and negating more than a decade of scientific achievements. What will happen? Probably nothing. The highest executives in Brazil never touch these issues. And this is not the first time something like this has happened. Some years ago, the Biotechnology Institute of the Federal University of Rio Grande do Sul was broken into and vandalized. Nobody was arrested. GM experiments in Brazil are destroyed all the time and nothing happens.

The Brazilian Law for Animal Experimentation has a section analyzing ways to reduce the use of animals in preclinical tests, but so far, there are no drugs in the world market that skipped preclinical tests with animals. Instituto Royal was under scrutiny by the authorities, seeking to verify that no animals were being mistreated.  All evidence for that investigation has now been destroyed and the animals have disappeared.

Can Brazil pass better legislation? If possible, this is the way to go. Destroying law-abiding institutions is an activity that will lead us straight back to the dark ages.

Luiz Antonio Barreto de Castro

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