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As officials work to contain the spread of the Zika virus, the prospect of combatting it using genetically modified mosquitos is struggling through layers of red tape and widely circulated conspiracy theories.
A top Food and Drug Administration official told members of Congress last week that the agency is hoping to expedite field trials of the genetically modified Aedes aegypti mosquitos produced by the British company Oxitec.
The mosquitos have languished in bureaucratic purgatory since 2011, when the company proposed using them to combat dengue fever. The company says it can now be used to prevent the spread of Zika, a mosquito-borne virus spreading through Central and South America.
The virus has spread in warm climates due to mosquitos breeding in pools of standing water, where Aedes aegypti larvae are rampant. Oxitec has genetically modified male mosquitos so that their offspring die before reaching maturity.
With global health officials increasingly alarmed at that spread, members of Congress want to know why FDA has taken so long to approve Oxitec’s mosquito for field trials.
“I’d like to see them move a little faster, but I say that without being upset at the FDA because it’s their job to be cautious. As long as they’re moving forward, I’m more satisfied,” said Rep. Morgan Griffith (R., Va.) in an interview.
Griffith quizzed senior FDA scientist Luciana Borio on agency delays at a hearing of the House Energy and Commerce Committee’s investigative arm last week.
“We are expediting review of this and very soon we hope to release for public comment the environmental assessment and the associated findings,” Borio assured him.
However, future delays are inevitable before Oxitec’s mosquito can receive FDA approval.
Federal law requires an environmental assessment before any genetically modified animals are released into the wild. The FDA then opens a public comment period on that assessment before field trials can begin. FDA sign-off might be required to make release of the mosquitos commercially viable not just in the Untied States but around the globe.
Experts say that public input is important, but that the agency has needlessly delayed the process.
“FDA promised last May to publish for public comment a routine environmental assessment of the Oxitec field trial in Florida,” according to a January Forbes column by Henry Miller, a Hoover Institution fellow who previously oversaw genetically engineered drugs at FDA, and John Cohrssen, the former counsel for the White House Biotechnology Working Group.
“This delay is unnecessary and unconscionable,” they wrote.
Griffith understands the risks posed by introducing genetically modified animals into the wild; as a Virginia state legislator, he opposed a plan to introduce sterilized oysters into the Chesapeake Bay.
Oxitec’s mosquitos are different, he says, since the company is modifying and introducing an existing species, which does not pose the same risk of ecological disruption.
“I think there is room [to shorten comment period] particularly in an urgent situation, and I think it would be helpful if they would shorten it,” Griffith told the Free Beacon. “I would hope that they would.”
Complicating efforts to get the genetically modified mosquitos into the field are conspiracy theories that have made their way from more obscure corners of the Internet—including the Russian government’s U.S. propaganda arm—into mainstream news publications such as the Daily Mail and Fox News.
Some have speculated that far from addressing the spread of Zika, Oxitec’s mosquitos are actually causing it.
“Concerns have been raised scientists could be to blame for the Zika virus outbreak after genetically modified insects were released into Brazil three years ago,” the Daily Mail wrote in January.
Miller says the idea is completely without merit.
“The nonsense about the Oxitec mosquitoes causing Zika infections has been effectively debunked,” he wrote in an email. “The infections are more likely to have been caused by aliens attacking us with biological warfare.”
However, Borio cited the “significant attention that this novel technology has generated” in pushing back against Griffith’s suggestion to “truncate” the public comment period at last week’s hearing.
Daniel Pérez, a policy analyst at the George Washington University’s Regulatory Studies Center, defended FDA’s insistence on maintaining its public comment period, but faulted the agency for delaying the process as long as it has.
“Public comment is very valuable in the rulemaking process,” Pérez wrote in an email.
“I think what’s important to note is that if FDA had not delayed so long on allowing the public to comment on this issue, they wouldn’t be facing the catch 22 of either meeting a perceived imminent need or missing out on the valuable feedback and opportunity of hearing the public’s input,” he said.
Though FDA rulemaking only directly affects companies’ abilities to market drugs and other products in the United States, “countries often take their ‘cue’ about regulatory issues from large regulators such as the U.S. and the EU,” Pérez said.
“Oxitec is currently active in Brazil—where it has (at least one) agreement signed to release its GM mosquito to reduce populations of Aedes aegypti,” he said. “Indirectly, however, other countries might make decisions about whether or not to allow the use of GM mosquitos within their own borders partially based on the decision of the U.S.”
It is not clear when Oxitec will be able to successfully navigate the U.S. bureaucracy. Griffith said he has not been given a timeframe on when to expect field trials for its genetically modified mosquitos.
“I would’ve preferred an answer, but I understand where the FDA is coming from,” he said. “The FDA’s supposed to be cautious and conservative so I’m not trying to bash them.”
The FDA did not respond to a request for comment by press time.