Jun 172016
 

oxitec cartoon 900 wide

by Alexis d’Albissin and Arnaud Girard…….

“We’re guinea pigs in their science experiment,“ said Dick Nalley. Like many of his neighbors in Key Haven, he has dotted his front yard with angry placards. The government, you see, together with a British biotech company called Oxitec, plans to release three million genetically modified mosquitoes into their small island neighborhood, 5 miles northeast of Key West. The ultimate goal is to test this new tool for stopping the propagation of the Aedes aegypti mosquito, which carries dengue, chikungunya, and Zika.

A 2013 Survey of Key Haven residents conducted by local mosquito control staff had concluded that over 90% of them were not opposed to the release. Either the survey was flawed or the residents changed their minds. This week, The Blue Paper is taking a look at the rights of people to refuse being involved in scientific experiments against their will.

Officially, Key Haven residents have nothing to worry about. The Food and Drug Administration reviewed Oxitec’s 140-page environmental assessment and concluded: “the probability of adverse impacts on humans or other animal health is negligible or low.”

“This could have a huge benefit for Key West,” says Michael Doyle, director of the county’s Mosquito Control District.  “With traditional tools,” which, in Monroe County, include insecticide, larvaecide, a helicopter, and a nearly 16 million dollar annual budget, “we eradicate only 50% of the Aegypti,” says Doyle.  According to Oxitec, their genetic mutation strategy eradicates up to 90% of the targeted mosquito.

key haven map of trial areasThis is how it’s supposed to work:  In its mosquito farms, Oxitec raises millions of Aedes aegypti mosquitoes which are bred with a defective lethal gene.  They stay alive only because their food is laced with an antibiotic [tetracycline].  When the adult males are released (at a ratio of 10 for every one wild male mosquito) they mate with wild females and pass that lethal gene onto their offspring. The larvae, without the benefit of tetracycline, die before reaching adulthood. In various areas infected with dengue, Oxitec claims to have successfully reduced the number of mosquitoes, boasting 90% eradication in Panama and Brazil and 80% in the Cayman Islands.

But, for many Key Haven residents, Oxitec is just a sorcerer’s apprentice and they are being forced by their government into becoming designated volunteers in an experiment that includes their blood, a Frankenstein mosquito, and a sinister third party: the dengue virus.

Some residents’ concerns don’t check out.  Many claim there’s been no peer review of Oxitec’s work.  In fact, both the Pasteur Institute in Paris and the University of Colorado have recreated the Oxitec procedure in their labs.  With some divergence as to the actual level of success, both found the process was effective in reducing the number of mosquitoes.  The fear that Oxitec mosquitoes would survive and reproduce by exposure to tetracycline in the environment such as in human trash or cat food was dismissed by researchers at the Pasteur Institute.

However, some concerns which might seem as though borrowed from a B-movie plot, actually do find an echo in the scientific world. Could the genetic modification of the mosquito cause a mutation of the dengue or Zika virus, turning it into a super virus?

According to Dr. Jan Medlock, a professor at Oregon State University, the genetic manipulation of the Aedes aegypti could impact the human viruses it carries. In 2009, Medlock and three other scientists published their research on The Impact of Transgenic Mosquitoes on Dengue Virulence to Humans and Mosquitoes. In a mathematical model, adapted to an epidemic situation, they found that there was a definite risk that the transgenic mosquito could trigger an evolutionary response by the dengue virus: the mutation could increase the virulence of dengue fever in humans.

While their analysis did not focus on Oxitec’s gene modification strategy specifically, it did consider similar genetically engineered mosquito eradication methods. In simple terms, the new gene could cause the virus to adapt to the changes in its host and mutate into a more dangerous form of the disease. In a telephone interview this week Dr. Medlock indicated, however, that he believed that the chances of such a mutation are very remote.

“It is frustrating,” says Dr. Medlock, “after what happened elsewhere, that Oxitec has not done a better job with consent this time.” In Malaysia and the Cayman Islands, Oxitec and the local governments it worked with didn’t tell residents about trials involving millions of GM Mosquitoes until a month after they were released.

For Key Haven residents consent is the crux of the matter. Under Article 7 of the International Covenant on Civil and Political Rights, “no one shall be subjected without his free consent to medical or scientific experimentation.”  “It’s a basic right of people,” says Medlock. The treaty, which originated in the United Nations, was ratified by the U.S. in 1992.

So how is Oxitec getting away with not having to obtain formal individual consent? When we reviewed Oxitec’s application with FDA, we found it had been filed with the FDA’s Center for Veterinary Medicine. In other words, the experiment in Key Haven is being processed as the approval of an “animal drug.” As for any drug involving only animals, no human consent is required.

Oxitec has been releasing millions of mosquitoes in open air experiments in residential neighborhoods, at times unbeknownst to residents. In Brazil, Oxitec adopted a more transparent method: One of the promotional slogans, spread throughout poor neighborhoods read, “Let these mosquitoes into your home. These mosquitoes are our friends.” How Brazilians were supposed to make the difference between a male transgenic mosquito and a dangerous carrier of hemoragic dengue before inviting them in is not explained.

Oxitec claims that: “Informed consent is a process for getting permission before conducting a healthcare intervention on a person. Our approach is emphatically not a healthcare intervention and we make no healthcare claims. Our aim is to control the mosquito population.” They go further: “FDA also sees this as an intervention for mosquitos with no human health claims – that is why it is being regulated as an animal drug and not a human drug.”

The UN treaty, however, is not limited to healthcare research but also includes any “scientific experiment.” The controversy about secret releases of millions of mosquitoes by Oxitec brought some harsh words from Anthony James, administrator of a 19.7-million-dollar transgenic mosquito testing program funded by the Bill and Melinda Gates Foundation.

“It’s my blood,” says Key Haven resident John Murphy. In fact, blood is an indispensable element of the Aedes egypti reproductive cycle.  The female mosquito (the only one that bites) cannot grow eggs without the protein and iron she finds in blood.  When she pumps up that special supper, she also injects her saliva into her prey’s bloodstream. That is when she passes on any virus she may be carrying.

As per Oxitec’s own admission, the experiment can only be carried out inside a residential neighborhood like the Key West / Key Haven area. Michael Doyle indicates that in less inhabited areas of the Keys, like Big Pine, the percentage of Aedes egypti can be as low as only 1% of the total mosquito population. For Mr. Murphy, unquestionably, the true subject of the experiment is that symbiotic relationship between Aedes egypti, humans, and the blood and viruses they share.

When it comes to “consent,” like Oxitec, FDA’s track record is quite murky.

In 1977 a US Senate subcommittee met to investigate the military’s testing of biological weapons simulants sprayed from aircraft over unsuspecting civilian populations in San Francisco, New York, and Key West. The FDA allowed the use of a placebo, that turned out to be a dangerous pathogen, in biological weapons research.

The exchange between senators and military brass make for interesting reading.

Senator Schweiker: the other question is, do you know exactly when the Florida test in Key West, the Monroe County area, was conducted? All I have is the year 1952[…]

Lt. Colonel Carruth: I do not have the exact date of that test. We could not find the report. We found only fragmentary data.

Senator Schweiker:  The other statistics. I want to bring out […] is disturbing in view of the Alabama figure [an increase to three times the normal rate of pneumonia] relates to the Key West test.  A lot depends on when the test was conducted. Because the Florida State health records show that the 1953 is the only year in which Monroe County’s rate of pneumonia […] exceeded the state-wide rate.

Senator Kennedy: I want to know what justification there was for this endangering of the public health and the disregard for individual human rights. 

In the end the Senate found that, “consent forms were largely inadequate” and “the FDA had inappropriately given up its responsibility for assuring that drug test subjects were fully protected.”

In the face of growing opposition, Monroe County is now preparing for a non-binding referendum on the Oxitec question. However, under federal guidelines community consent cannot replace individual consent.

So why does the Key Haven trial seem so important to Oxitec? The answer may be money.  A lot of money. Until recently Oxitec’s website opened up with a presentation showing some alarming numbers about the world-wide impacts of dengue fever; with 390 million dengue infections a year.  It followed with the fact that there was “no known vaccine” for dengue fever.  Immediately thereafter came a description of the great financial prospects for Oxitec on the stock market and the opportunity for investors to get very rich – very soon.

Since then however French pharmaceutical company Sanofi, in association with the Pasteur Institute and a research center in Delhi, India has perfected a dengue vaccine. By April of 2015, Sanofi was already engaged in a program aimed at vaccinating one million school children in the Philippines. Dingvaxia is approved for all 4 serotypes of dengue fever. Not good for Oxitec shares.

Oxitec trials in the developing world have also been overrun by controversy. In Panama, in spite of triumphant statements by Oxitec, its government partner, the Gorgas Institute, called the results of the trial “inconclusive”: $620,000 was spent to reduce the number of mosquitoes in a neighborhood of only 200 families.

In the 2010 trial in the Cayman Islands, Oxitec ended up releasing three times more mosquitoes than projected. 25 transgenic males were released for every 1 wild male mosquito to achieve an 80% reduction in the mosquito population.

In Northeast Brazil the overlapping of the release of Oxitec transgenic mosquitoes with a Zika epidemic is a source of much controversy as to the safety of the Oxitec protocol. Could the transgenic mosquito have caused the “evolutionary response” described in Dr. Medlock’s mathematic model? Could the transgenic mosquitoes have helped the Zika virus mutate from the benign head-ache and skin rash to the nightmarish head-shrinking virus it is today. There is no definitive response to those questions, but the languishing uncertainty doesn’t help Oxitec.

Blue Paper columnist, Dr. Martha Huggins, also pointed out that Oxitec’s credibility is overshadowed by the presence of multi-millionaire Ronildo Pereira Medeiros as a member of  the United Kingdom’s Oxitec board of advisors for Brazil.  Madeiros has been embroiled in highly publicized bribery scandals, and could be perceived as a man who would bend scientific truths for profit.

With a cheap vaccine at the gate and rumors of impropriety running wild on the net, Oxitec desperately needs a bonafide success story in the developed world, preferably in the US. It needs the stamp of approval from the FDA. Key West, with sporadic dengue outbreaks, and its affluent island suburb of Key Haven would be a perfect fit.

In August of 2015 Oxitec was bought out, for 160 million, by Intrexon, a biopharmaceutical company. Success in Key Haven could be publicized worldwide and held up against the highest standards. Transgenic mosquito programs could finally be sold with government backing and financial grants backed by big brother, USA.

“The British scientific establishment is acting like the last bastion of colonialism,” said Dr. Helen Wallace, of GeneWatch, using the rest of the world “as a private lab.”

Obtaining the consent of residents is not impossible.  In 2012, in Queensland, Australia, a controlled release of mosquitoes carrying Wolbachia [a disease that kills wild mosquitoes] did just that. Renowned mosquito expert, Dr. Scott O’Neil and his team obtained the written consent of every resident who would participate in a neighborhood release; the few who objected were excluded from the experiment as were their adjacent neighbors.

“Nobody asked us if we wanted to be a part of what is –  clear and simple- a medical experiment,” said Key Haven resident John Murphy.  Ultimately the issue in Key Haven is not just whether the Oxitec process is safe or efficient or if people believe it is safe but rather whether they have an inalienable right to say “no” to a scientific experiment involving their blood regardless of their motives for refusing to do so.

Consent of patients is not a medical “safeguard,” it is about a basic human right.  Under the 1992 treaty, it doesn’t matter if the FDA concludes the risks are “low or negligible.” Article 4 of the treaty prohibits any regulatory infringement on the basic human right to say, “I don’t want to be part of your experiment.”

With possibly one of the highest percentages of lawyers per square yard in Florida, could Key Haven be more trouble than it’s worth? Or perhaps Oxitec needs to follow the advice of Jack Nicholson in A Few Good Men: “You have to ask nicely.”

~~~~~~~~~~~~~~

Key Haven residents are not alone: A change.org online petition was recently published by Cayman Island residents opposing a new release, without consent, of millions more of Oxitec’s GM mosquitoes there aimed at combatting the Zika virus.

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  11 Responses to “Oxitec: Lord of the Mosquitoes”

  1. Thanks for what seems to be a lot of hard, extensive investigation and reporting, with more than a little humor :-).

    Embracing the feminine side, I bet my own life and soul that Arnaud’s deliciously devilish Lord Oxitec cartoon tells his own soul’s version of the true genetically-altered Aedes aegypti mosquito story.

    Am reminded of Arnaud’s deliciously devilish cartoon of the “Costa Giganta” black fume-spewing cruise ship with a human butt for a stern dumping a wide, long brown trail of human waste as it enters Key West’s harbor during the run up the “channel-widening” referendum a few years back, when the referendum’s backers kept saying the referendum was not about cruise ships, even though the entire reason for studying making the channel wider was a wider channel would allow longer and wider cruise floating cities to call on Key West, and would reduce the number of the regular size floating cities having to turn away from Key West when the wind blew in from a direction that prevented them from crabbing (tacking) into the channel.

    Now I know in today’s modern, scientific, left brain, testosterone-driven world, art, the feminine side, intuition, et cetera, et cetera, are about as revered as Eve in Genesis. I also know the feminine persuasion’s low position in humanity is what’s wrong with humanity.

    I mean, do you think it was estrogen that caused Daddy Bush to invade Kuwait to save its oil for America?

    Do you think it was estrogen that caused Baby Bush to invade Afghanistan, and then Iraq, to save America from …

    Exactly what did those testosterone wars save America from?

    What was and will be the final cost of those wars in $$ and in human lives and body mutilations, and emotional, mental and soul fracturing?

    Those wars gave rise to radical Islam, didn’t they? To 9/11, yes? To the San Bernadino shootings To the Orlando massacre? To World War III? To assault rifles in the hands of just about any American who wants one?

    Well, perhaps I digress – LOL

    I dunno, there is something super weird and disturbing about the spike in Zika and deformed baby heads in Brazil after Oxitect’s lab-engineered hybrid skeeters were released there. There also is something super weird and disturbing about nobody yet seeming to have a clue why that happened.

    So, is this one of those moments which the big tribe of lawyers living in tiny Key Haven are supposed to rush forward and say, “Hey folks, res ipsa loquitur! – that’s Latin, for the thing speaks for itself!”

    Is this one of those moments when Last Stand and Florida Keys environmentalists are supposed to rush forward and say, “Hey folks, we all know it isn’t smart to mess with Mother Nature!”

    Is this one of those moments when Key West’s many poets are supposed to rush forward and say, “Hey folks, we all know the heart has its own reasons which reason knows nothing of!” And, “There is more in heaven and earth, Horatio, than there is your philosophy!”

    Note no question marks in those rhetorical questions.

    Now, to give the devil his due …

    I spoke a good while with Mosquito Control Board member Steve Smith during Hometown PAC’s call to candidates last April. Here are some things I recall Steve said.

    There aren’t many Aedes aegypti mosquitoes on Key Haven, or on Stock Island. Aedes like to hang out in Key West, because of its extensive tree canopy. During the day, Aedes hide under the trees’ leaves, where they are really hard to reach with aerial insecticide spray released from Mosquito Control’s helicopters. So Key West is where any genetically-altered mosquitoes should be released. And to do the genetically-altered study right, all other forms of mosquito control should be discontinued. For if you keep aerial spraying to kill adult Aedes, and aerial spaying larvicide to kill Aedes eggs/larvae, that will contaminate the test. And probably the test should last maybe up to 2 years.

    Steve said he would bring all of the above to Mosquito Control Board’s attention. I don’t know if he did that.

    Steve also said Mosquito Control once did a very good job controlling Aedes by having boots on the ground all over Key West and the Florida Keys. Mosquito Control people going through neighborhoods, into yards, finding standing water in which Aedes breed, and getting rid of that standing water. But since Phil Goodman got on the Mosquito Control Board and won support about cutting costs, boots on the ground was cut way back and Aedes mosquitoes increased. Steve said there is no need for genetically altered mosquitoes, if boots on the ground are resumed at their old level.

    Steve also said Key Haven is too small an area to be a good genetically-altered Aedes test. Key Haven is surrounded by nearby Keys, which will not be tested. The definitive test should be done in Key West, where Aedes is a problem. For up to two years. Without using any other form of mosquito control.

  2. Wow, this is thorough and very interesting. Thank you for this important article. Martha Huggins

  3. Another superb article from The Blue Paper research team!

    The research that I did revealed that cat food given to larvae disabled the “kill gene” from just the trace amounts of tetracycline that were believed to have originated in the chicken content. Chicken feed has antibiotics added in at the feed producers, so most chicken has traces. There may also be another chemical that disables the kill gene that is as yet undiscovered or undisclosed.

    Sufficient tetracycline traces are known to persist in wastewater plant effluent, so that reclaimed water that is used for irrigation may not only provide a place for larvae to grow, but may also provide the “antidote” for the kill gene. The Key West golf course uses reclaimed irrigation water from the Stock Island WWTP.

    As in all reproduction, genes are not all faithfully transferred to the offspring, and it is admitted that a percentage of the offspring do not die before further reproduction. I think it was 3% that Oxitec admitted as viable reproducers. Since millions of Oxi513A would be released on a continual basis, that is 30,000 viable Frankenskeeter reproducers per million.

    If Oxi513A are released at a rate of 25 Frankenskeeters per wild ‘skeeter, and all “get lucky” at the same rate, then the population reduction might be expected to be 96% rather than 90%. I read research that indicated that Oxitec’s claims of 90% reduction were exaggerated. Even the disparity of 96% vs 90% in the short term experiments should be sufficient to make one question the long term success rate of the method.

    Let us not forget that focusing on one species by GMO tactics allows other species to proliferate in the absence of any other mosquito control method at all- short of swatting the little bloodsuckers. The Asian tiger has already proven to be a more deadly threat, and they are aggressive and fast.

    I predict that all the protests will be ineffective to prevent this experiment from being carried out. At best, it might be transferred to an island where there are fewer of Sloan’s angry lawyers. Experiments such as this are usually carried out in less affluent areas. Curious. Is this an attempt to clear out the live-aboard and homeless population nearby with a 25 times greater skeeter population while the affluent sit safely within their air-conditioned homes? I would not for a moment doubt that a mosquito borne disease may “mysteriously” break out in Key Haven or elsewhere in the Keys, and the resultant public panic allow release of the new life form.

    It is so wrong to have a Keys-wide referendum on a Key haven release. For distant Keys, it’s not “in their backyard”, and they can be more easily influenced by big corporation propaganda while less likely to have seen thoughtful articles like this that present the view of those not in position to profit from the release.

  4. I forgot to say how much I like Arnaud’s art!
    His images indeed convey a thousand words!
    Bravo!

  5. VERY WELL DONE! INVESTIGATIVE JOURNALISM AT ITS BEST.

  6. testing comment functionality…

  7. Jerry Weinstock, M.D., Psychiatry, retired, of Key Haven, emailed me about this blue paper article and my comment under it. (Jerry many times has emailed me that Oxitec’s science is sound and people who oppose GMO mosquitoes are ignorant.)

    “When We arrived in Key West –moving here in 1966 permanently–we rented a run down House on Sugarloaf —-mosquito control came around carefully checking for standing water—at least once monthly—–that worked but spraying was still necessary;

    “pesticides —many carcinogenic —still are being used—sprayed–…

    “genetically altered —-(salivary glands ) is by far the better safer method.

    “the examples you and others are using are organically altered molecular structured
    compounds NOT genetically related in any sort of way—-these are the ones with side reactions as they are lethal and toxic.—–

    “I would not expect most people to understand all the basic molecular differences. genetic will be the wave of the future –by far better than toxic spraying–

    “(-Of courseI totally agree with you and others) boots on the ground checking for standing water–the best way of controlling this problem.. always has been”

    I replied to Jerry:

    “Reading your email, a question came to me. Are you and Donna (his wife), for example, okay with Oxitec’s male (and some regular female) Aedes aegypti mosquitoes being released in Key Haven for maybe up to 2 years, with no other mosquito control methods used, as a scientific test to evaluate the effectiveness of Oxitec’s hybrids in Key Haven? I would think if you truly believe Oxitec’s science, your answers will be yes.”

    Jerry wrote:

    “What do you think?”

    I replied:

    “I haven’t a clue. A simple yes or no would have been sufficient.”

    Jerry wrote:

    “Too complex”

    • Sloan, I don’t believe that is accurate. Key Haven would be cut into three zones. Treated area, Untreated area, and a buffer area in between. I just added an image showing a map of those areas to the article. All zones would continue to have normal treatments. One zone will get the GM mosquitoes. It’s assumed that Mosquitoes normally don’t fly more than 200 meters [roughly 500 feet]. They will then compare mosquito population…

      • I never said there would be no other mosquito control efforts used. I said in my first comment under Alexi and Arnaud’s excellent article, that Mosquito Control Board member Steve Smith said, for the release of GMO mosquitoes to be a true scientific test, all other forms of mosquito control would have to be dispensed with in the test zone, for up to perhaps 2 years, and Steve said he was going to take that up with the Mosquito Control Board. Admit, I put the question to him, and he said, yes, the test would have to exclude all other forms of mosquito control now being used, for the test to be valid.

        I figured Mosquito Control, and the people in Key Haven pushing for the GMO release in Key Haven, one of whom is Jerry Weinstock, had never considered, nor would they agree, to the GMO release being made a true scientific test, despite Jerry’s ongoing barrage to me of Oxitec’s science being accurate, and the supremacy of science over anything else. So, I decided to see just how sure Jerry and others in Key Haven clamoring for GMO mosquitoes to be released there actualy are – not in the least, they want GMO SKEETERS ON TOP OF EVERYTHING ELSE. As, I bet, does Mosquito Control.

        If they go at it that way, they won’t get a true read on the GMO release. Arnaud’s drawing is the true picture, as I wrote in my first comment under his and Alexi’s excellent article. Except, Arnaud left out Lord Oxitec’s allies in Key Haven :-).

  8. P.S., as I wrote in my first comment under your article, Steve Smith also told me there aren’t many Aedes aegypti in Key Haven, nor even on Stock Island. Key West is Aedes Haven, and that’s where any GMO skeeter release should be done, therefore.

  9. Why not pick something like the FL Everglades where dam few people live.

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