Tuesday, June 19, 2018
Health

Federal government approves trial to fight Zika in Key West, but residents can still hold it up

The federal government on Friday approved a field trial that would release millions of genetically-modified mosquitoes in Key West to eradicate the mosquito that carries Zika.

But British company Oxitec, which has already used its technology to reduce the Aedes aegypti population by 90 to 99 percent in parts of Latin America, is still held up by residents of a Key West suburb who are skeptical of the science.

In a statement, the U.S. Food and Drug Administration said Friday the Oxitec trial would have no significant impact on the environment. The government had released similar preliminary findings in March.

The FDA, which began reviewing the technology in 2011, handed down its approval two days after a Tampa Bay Times article detailed the Oxitec mosquito scuffle in the Keys, and amid a small outbreak of Zika in the Wynwood neighborhood of Miami, the first local transmission confirmed in the United States.

"We read the newspapers, we see the disease coming, and I think that's added a little bit of urgency and prioritization to that work," said Haydyn Parry, CEO of Oxitec.

The biotech firm has already released more than 150 million non-biting male mosquitoes in Brazil, Panama and the Cayman Islands to combat Zika. The males mate with the natural population of female mosquitoes and pass on a "death gene" that kills their offspring. In every trial, the Oxitec mosquito has killed more than 90 percent of the Aedes aegypti mosquito population. These results take about six months.

Oxitec chose Key Haven, an affluent suburb, for its United States trial after the Florida Keys Mosquito Control District invited its scientists in 2011 amid an outbreak of dengue. Once the Keys trial is complete, scientists could use this technology to wipe out the Zika-carrying mosquito in any part of the country.

But resistance from residents of Key Haven — who don't trust the genetic modification process and fear everything from a mutant Zika strain to the sterilization of bitten children — has kept their local officials from signing off on the project.

Instead, Key West officials are refusing to sign off on the test run unless its citizens approve the measure in a November vote.

Stephen Smith, vice chairman of the control district board, said he did not expect FDA approval to change the board's decision to let people vote. "I do put value in the FDA's judgement and their opinions," he said Friday. "I don't think all of the world does. I think some people kind of brush it off as they just rubber-stamp things. So who knows?"

Michael Doyle, the director of the control district, said he believes the FDA approval will sway more people to vote in favor of the Oxitec technology in November. Many people already support the trial, said Doyle, but fear speaking out against the opposition.

"It's a small community where you can't go to the grocery store without running into four to five people you know, and then there's small businesses. If some of the small businesses came out for it, the opposition group could do a boycott," Doyle said.

With the Keys vote three months away, Oxitec has been receiving inquiries from towns across the country as local transmission of Zika rocked Miami last week. To test its technology in a site other than Key Haven, the firm would have to receive an additional approval from the FDA.

Parry, the Oxitec CEO, speculated the FDA could trigger its "emergency use authorization" to allow for the immediate use of the modified mosquito as the threat of a Zika epidemic looms. The government has already approved six other technologies through this means for the treatment of Zika.

But a spokeswoman for the FDA said the emergency use authorization was not on the table for the Oxitec mosquito because it technically is an "animal drug," tested on mosquitoes and approved through the FDA's Center for Veterinary Medicine.

"There is no explicit 'fast-track designation for new animal drug approval," said Theresa Eisenman, press officer for the FDA.

This was little salve to Florida citizens and lawmakers concerned about the spread of Zika, which can cause autoimmune disorders, temporary paralysis and even death. Zika can be sexually transmitted, and pregnant women who catch Zika are giving birth to babies with microcephaly, a birth defect characterized by a small head and rock-like, underdeveloped brain.

"I think this is probably the best tool at our disposal at this time," said Florida Rep. Chris Sprowls, R-Palm Harbor. "Zika is very alarming to me, and I want to know, what can we do?"

His wife, he said, is pregnant.

Contact Lisa Gartner at [email protected] Follow her @lisagartner.

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