FDA: GMO mosquito is environmentally safe to use in Zika fight

New studies show links between Zika and brain effects, birth defects.

Posted by Leslie Eastman Sunday, March 13, 2016 at 12:30pm 7 Comments

https://commons.wikimedia.org/wiki/Aedes_aegypti#/media/File:Aedes_aegypti_during_blood_meal.jpg

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As of our last report on the Zika virus, the number of confirmed cases of infection among those living in the United States was steadily rising and several woman had pregnancies that were likely impacted by the mosquito-borne pathogen.

While President Obama says “not to panic“, the normally glacially responsive Food and Drug Administration took the initial steps to pave the way for the use of genetically modified mosquitoes in the fight to eradicate the virus. The agency has just published a draft of its environmental impact study of OX513A, a male Aedes aegypti mosquito genetically modified to pass on a lethal gene to his offspring.

According to the FDA, the release of this GMO male in a Key West suburb as part of a field trial will have “no significant impact” on the health of the local environment or the people who live in it.

“While we didn’t expect anything different, we’re pleased the FDA has now published their data,” said Haydn Parry, CEO of Oxitec, the British company that developed OX513A. “Now we want to get everybody comfortable with the decision.”

This study is one of many that have been quickly generated after news broke of the significant numbers of babies born with microcephaly in South America, as well as the development of neurological conditions post-infection. Researchers now report that Zika virus may be associated with a deadly type of brain inflammation.

Researchers found the Zika virus in the spinal fluid of an 81-year-old man with meningoencephalitis, a dangerous inflammation of the membranes that surround the brain, according to a report from French researchers in The New England Journal of Medicine.

The man had been on a cruise in the South Pacific near New Zealand, New Caledonia, Vanuatu and the Solomon Islands.

Additionally, two new studies strengthen the connection between Zika infection and birth defects.

In the first study, published in The New England Journal of Medicine, researchers found that 29 percent of women who had ultrasound examinations after testing positive for infection with the Zika virus had fetuses that suffered “grave outcomes.”

They included fetal death, tiny heads, shrunken placentas and nerve damage that suggested blindness.

….The Brazilian study, which is still in progress, followed 88 pregnant women who visited a fever clinic at the Oswaldo Cruz Foundation hospital in Rio de Janeiro, one of Brazil’s leading research hospitals, between September and February.

Every woman with a rash, the most characteristic symptom of infection, was tested for the Zika virus, and 72 were positive. The tests looked for the virus itself; they work only if done early in an infection, but are considered more accurate than later tests for antibodies.

Forty-two of the infected women agreed to have a series of ultrasound scans, as did all 16 uninfected women.

… The bleakness of the results was startling. Of the 42 infected women receiving regular ultrasounds, a dozen had babies who died in utero or suffered serious birth defects. Only eight of the babies carried by the 42 women have been born so far, but the ultrasound scans for them turned out to be accurate. None of 16 uninfected women had problems in their scans.

Meanwhile, Kansas becomes the latest state to report a Zika infection, which was likely attained during travel.

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TheFineReport.com | March 13, 2016 at 2:25 pm

When a weasel like Obama says, “Don’t panic,” it’s time to panic.

Archer in reply to TheFineReport.com. | March 14, 2016 at 2:33 pm

Obama saying “Don’t Panic” is right up there with Reagan’s Nine Most Terrifying Words in the English Language:

“I’m from the government, and I’m here to help.”

tom swift | March 13, 2016 at 2:37 pm

C’mon, people, there are these things called links.

The FDA’s Preliminary Finding of No Significant Impact, a mild six pager (six pages of governmentese, but still just six pages)—

http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM487379.pdf

And the more heavy-duty 384-pager from Oxitec, Draft Environmental Assessment for Investigational Use of Aedes aegypti OX513A—

http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM487377.pdf

tom swift in reply to tom swift. | March 13, 2016 at 2:41 pm

The big file might be wonky; sometimes it doesn’t D/L gracefully.

Your tax dollars at work …

OldSarg | March 13, 2016 at 2:43 pm

If I lived in Brazil I would manufacture DDT and spray the whole dang area down. . . It saved the United States. . .

genes | March 13, 2016 at 8:09 pm

The Anti-Vaccination crowd claims it’s the vaccines and that all this is just a Big Pharma conspiracy.
I’m thinking I should have bought stock in R.J.Reynolds.

Sammy Finkelman | March 14, 2016 at 1:08 pm

http://www.wsj.com/articles/the-u-s-is-botching-the-zika-fight-1457907116

Excerpt:

Using genetic engineering techniques, the British company Oxitec (a subsidiary of American-owned Intrexon) has created male Aedes aegypti mosquitoes with a specific mutation that causes them to need a certain chemical (the antibiotic tetracycline) to survive. Without it, they die—and their offspring die before reaching maturity. Releasing the males over several months causes a marked reduction in the mosquito population. Because male mosquitoes don’t bite, they present no health risk, and, because their progeny die, no genetically engineered mosquitoes persist in the environment….

…But in the U.S. the FDA has been paralyzed, unwilling to permit even small-scale testing. How did the feds go wrong?

The first problem is that the FDA and the Agriculture Department are stepping on each other’s turf. The technique of using sterile insects to control pest populations was developed in the 1940s by the USDA’s E.F. Knipling. He used irradiated males to eradicate the New World screwworm, a nightmarish parasite that attacks livestock and humans, from the U.S. and much of North America.

The Oxitec mosquito should be regulated by the USDA’s Animal and Plant Health Inspection Service, which has the authority and expertise to oversee field trials and commercialization of genetically engineered insects. But for a combination of reasons—including budgetary concerns and antagonism to genetic engineering among some senior USDA officials—the department demurred. It ceded jurisdiction to the FDA, which is unqualified to review the mosquito and unwilling to move it along.

The FDA regulates the genetic material introduced into the mosquito as a “new animal drug”—similar to the way it regulates flea medicines and analgesics for dogs and cats. This was an unwise policy decision, but that is a story for another day. According to statute, the genetic material must thus be shown to be safe and effective for the animal.

To approve the Oxitec insect, then, the FDA must employ logic that only a regulator could love: It must somehow conclude that the genetic material that causes a male mosquito to self-destruct after producing defective offspring is safe and effective for the mosquito. The FDA could find itself tied up in legal knots if its ultimate approval of the insect were to be challenged in court by environmentalists or anti-genetic-engineering activists.

Nevertheless, in 2011 the FDA, apparently whistling past the graveyard, accepted Oxitec’s application to perform a field trial in the Florida Keys. But the gears of government grind slowly, and the release of the first test mosquito is still nowhere in sight. Last May the FDA announced that a proposed environmental assessment of the trial would be issued. The draft assessment, finding “no significant impact,” was finally released last week. Now we must wait 30 days, at least, for public comment. Then the FDA will analyze the comments and decide whether to issue a final assessment or prepare a complete environmental-impact statement—which could take years.

For the USDA’s part, in 2011 its Office of Inspector General issued a report highly critical of the department’s oversight of research on genetically engineered animals and insects. It concluded that there had been no progress since 2007, when a new Animal Policy Branch was established in an effort to delineate regulatory authority for genetically engineered animals. The department responded to the report by committing to develop a regulatory framework by the end of 2011. We’re still waiting….

FDA: GMO mosquito is environmentally safe to use in Zika fight