GMO bananas could be fed to humans without doing animal toxicity testing first

In what appears to be a "new norm", GMO researchers are going straight from genetically modifying a banana to trials on humans without doing the ethically necessary step of testing for toxicity on animals first.

The researchers are planning to feed their GMO banana to students in Iowa, apparently without any prior animal toxicity testing. This would be illegal in Europe, where developers would have to do a short 90-day test in animals first.

Going straight from GMO development to human trials is exactly what happened with the GM golden rice trials, where GM golden rice was fed to children without informed consent and without prior animal testing. The lack of animal testing was condemned by international scientists as a breach of the Nuremberg Code, established after World War II to prevent a repeat of Nazi experiments on humans.

Similarly, the GMO purple tomato developed by Cathie Martin at the John Innes Centre appears to be destined for human trials without being put through animal toxicity testing first.

The small trial in mice carried out by Martin's team was not a toxicity test. It seemingly looked only at one endpoint - lifespan. It would not have picked up common health risks such as liver and kidney toxicity and the researchers do not appear to have examined basic toxicology parameters such as blood and urine chemistry, organ status, or hormonal levels.

Perhaps this neglect of minimum safety standards is what we can expect when plant scientists are allowed to develop novel foods. Many of them do not have a background in human and animal biology or toxicology and simply do not comprehend that a plant can be rendered toxic or allergenic by what they see as an insignificant genetic tweak.

The students recruited for the Iowa trials should recall the precedent of Porton Down in Wiltshire, UK, where scientists carried out unethical human experiments for years under the false pretence that they were safe. For example, subjects were told that they were participating in "research on the common cold" when in fact they were being exposed to deadly nerve toxins.

Before agreeing to eat the GMO banana, the students should ask the researchers: "Where's your animal data?" Responsible scientists would welcome such questions.

(Comment by Claire Robinson)

ISU researcher to test altered bananas

Tony Leys

The Des Moines Register, 2 August 2014

http://www.desmoinesregister.com/story/news/2014/08/02/isu-researcher-test-genetically-altered-bananas/13502003/

A dozen Iowa State University students will soon get the chance to earn $900 by eating the equivalent of three bananas each.

There's a catch: One of the bananas will include a gene that scientists inserted to help people make vitamin A.

Such studies can be controversial, because natural-food proponents have raised doubts about the safety of genetically modified fruits, vegetables and meats.

ISU researchers are among the legions of scientists who say such foods are safe, but they kept details of the banana study under wraps. They relented this week after the Register raised the likelihood that by refusing to disclose their intentions, the researchers could fuel speculation that they were up to something hinky.

Wendy White, a food science professor leading the study, said the goal of the research is to help people in Africa increase their production of vitamin A.

"In Uganda and other African countries, vitamin A deficiency is a major contributor to deaths in childhood from infectious diseases," White wrote in a statement released by the university. "Wouldn't it be great if these bananas could prevent preschool kids from dying from diarrhea, malaria or measles?"

The bananas were developed by scientists at Queensland University of Technology in Australia, with grant money from the Bill and Melinda Gates Foundation.

ISU sent an email to all female students, asking for volunteers for the study. The email said participants would eat a diet, including genetically modified bananas, provided by the researchers for four days during each of three study periods. They also would have their blood tested to see how their bodies were reacting.

The diet is to include the equivalent of three bananas, including ones that have been modified and ones that haven't. More than 500 women responded to the query, and 12 will be selected, ISU said.

Speculation about the planned trial circulated among natural-food proponents after National Public Radio reported on it last month.

White declined to share details of the study with NPR, saying that disclosure might spoil her chance to have the results published. University spokeswoman Annette Hacker told the Register early this week that such details would not be released until the study's results were published. But by midweek, White agreed to outline the study via Hacker.

The scientist said the new type of banana includes a gene taken from another banana species, which naturally produces large amounts of beta carotene. When people eat beta carotene, their bodies convert it to vitamin A.

Residents of Uganda and nearby countries don't favor the type of sweet banana that naturally carries the extra beta carotene, White said. So researchers put the gene into a less-sweet type of banana that East Africans often use in cooking.

White noted that she led a similar study a few years ago, with six women eating porridge made from corn that was altered to produce high levels of beta carotene.

A California scientist who has raised doubts about such studies said last week that he has qualms about the ISU trial of the bananas. Dave Schubert, a neurobiologist for the Salk Institute, said he became concerned when he read that ISU researchers weren't disclosing how the banana trial would be conducted. But even after they relented this week, he said he wants to know more.

Schubert said high levels of beta carotene or vitamin A can be dangerous. For example, he noted that pregnant women are advised not to take high-dose vitamin A supplements because they can raise the risk of birth defects.

Schubert said he doesn't oppose all genetic modification of plants. For example, he said, he supports the idea of inserting some genes that help plants protect themselves against diseases. But he said the issue becomes dicier when scientists start splicing in genes to induce plants to produce substances for humans to digest.

"That is a whole different ballgame," he said. It's hard to predict how a gene from one plant will affect another plant, he said. "Plants can be really weird."

A national research ethics expert said ISU was smart to release details of how its study would be conducted. "The idea of transparency in human trials is incredibly important," said Steven Miles, a medical professor at the University of Minnesota's Center for Bioethics.

Miles said conspiracy theories tend to thrive in the dark. That can be especially true when scientists from rich countries, such as Australia and the United States, are developing foods or medicines for residents of poor countries, he said. Any perceived secrecy during the research can fuel resistance among the people the scientists are trying to help.

Miles said White's research sounds "completely reasonable." He said he would have no hesitation about taking part in such a study if someone asked him to volunteer.

Schubert also said he doubted the 12 Iowa State students would face much danger from the brief exposure to genetically modified bananas. His main concern is that the small trial would lead to larger studies, in which thousands of people would eat the fruit for longer periods of time.

The California scientist pointed to a recent controversy in which Chinese children were fed "golden rice" that had been modified to have extra beta carotene. The children's families allegedly weren't told what they were eating. The Chinese government fired three scientists in 2012, and Tufts University in Boston sanctioned a researcher involved in the study, according to national media reports.

Schubert said late this week that such a trial in humans, even in just 12 people, should not be attempted before researchers have fed the modified fruit to animals to check for safety. Hacker, the ISU spokeswoman, said White was traveling Friday and was not immediately available to comment on whether such a safety test was done on the bananas.

ISU officials stressed that White's study was vetted by a university ethics committee, and they said it would be registered with federal regulators before it begins this fall. They also noted that federal authorities have declared genetically modified foods safe, and that there are a range of similar vegetables and fruits already being consumed.