Tag Archive | "FDA"

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GM Mosquitoes May Piggyback the Zika Virus

Posted on 09 April 2016 by Jerry

Genetic modification of a male mosquito whose offspring die before they mature and mate can be used to kill a certain kind of mosquito (Aedes aegypti) that carries dengue fever, chikungunya, yellow fever and now Zika virus.  Oxitec, a company out of the United Kingdom, produces this mosquito, with an engineered “self destruct” gene.

This company provides only one of three ways to drastically reduce the number of the offending mosquitoes.  The other two ways are using male mosquitoes that have been sterilized by low doses of radiation and/or a mosquito that is infected with the Wolbachia bacteria.  These bacteria do not infect humans but prevents eggs of infected females from hatching.  All of these approaches entail releasing large numbers of male mosquitoes into the environment.

The Oxitec genetically modified mosquito has been tested in Brazil, the Cayman Islands and a trial has been proposed in Florida.  Now the World Health Organization is very interested in the Oxitec mosquito as a viable way of stopping the spread of the Zika virus.

The U.S. Food and Drug Administration (FDA) has tentatively agreed that the Oxitec genetically modified mosquito would not have a significant impact on the environment as a result of a trial in Florida.  The FDA report states, “The FDA found that the probability that the release of OX513A male mosquitoes would result in toxic or allergenic effects in humans or other animals is negligible.”  The FDA has to wait for public comment before giving final approval of the trial.  The process will probably take a few months.

Genetically modified insects have been introduced into the environment to protect or enhance crops for a number of years.  This however, will be the first GM insect introduced into the environment to have a direct effect on human beings. 

The problem is that use of this genetically modified mosquito has opened up quite a bit of controversy.  An opponent of the genetically modified mosquito, Jaydee Hanson a senior policy analyst at the Center for Food Safety, has been quoted in a Bloomberg news article published on 1/29/2016.  He said “Mosquitoes are food for lots of animals; We would still want to see studies of when birds and bats and amphibians eat these genetically modified animals.  They’re introducing into the ecosystem some genetic constructs that have never been there before.”

The same article quotes the Oxitec CEO Hadyn Parry as arguing the opposite position.  He said, “You always get some people who say I don’t like genetic engineering because it’s a bad thing and we’re messing with nature.”  Referring to criticism that his mosquito might die out and another will come to the fore, he has also been quoted as saying, “So in the very worst case, where you find that you eliminated Aedes aegypti in an area and the Aedes albopictus went up, then you would actually be replacing a very dangerous vector with a far less effective one.”

You know that there are two other options that could be used to stop this type of mosquito that do not involve genetic modifications.  There are male mosquitoes of the same species that are exposed to low-grade radiation that sterilizes them and there are males that pass on the Wolbachia bacteria that make it so female eggs do not hatch.  Both of these two methods use males to mate with females to cause an end to successful fertilization and replication.

The question becomes why are we moving to choose the method that requires genetic modification.  The only answer that is probable is that we want to see a genetically altered alternative in the market.  This is a continuation of the government push for genetic engineering.   There have been numerous articles on this blog going back to the June 13, 2012 posting of Genetic Engineering Influence Peddling and Profit (see www.iamaguardian.com/category/protect/genetic-engineering/page/4/ ) that show the government’s bias to push for genetic modification products.

This support is hidden from the average citizen’s view and is the reason we are seeking a genetically engineered alternative.  There are just too many economic interests to be satisfied.  These, as an example, range from educators to scientists to entrepreneurs to established major competitors like Monsanto and to politicians.  The U.S. voter should rise up and call for a hiatus on approval of genetically modified products until there is proof that these products do not represent a threat to our health.

The FDA approved the first genetically modified animal intended to be human food in the AguAdvantage Salmon for sale and consumption in the U.S. sometime after November of last year.  Fortunately members of Congress disagreed.  On page 106 of the 2016 federal spending bill congress people added a requirement for the FDA to not allow the selling of this product in the U.S. until the agency puts in place labeling guidelines and “a program to disclose to consumers” whether a fish has been genetically modified.

We have a very short time to influence this genetic engineering issue.  We should insist that our candidates for president address this issue for us so we know where they stand on genetically engineered foods.  In all cases we should ask for regulation and oversight by a newly established governmental agency that dramatically slows the headlong rush to get these products into the market. 

Use the following links to access more information or read the source documents used to prepare this article.

https://www.washingtonpost.com/news/energy-environment/wp/2016/02/04/what-it-would-really-take-for-gmo-mosquitoes-to-solve-the-zika-crisis/

http://www.theguardian.com/environment/2014/jun/10/gm-mosquitos-malaria-genetic-modification

http://www.bbc.com/news/world-latin-america-35585656

http://www.bloomberg.com/news/articles/2016-01-29/genetically-modified-mosquito-may-become-weapon-against-zika

http://www.theatlantic.com/health/archive/2015/01/Genetically-Modified-Mosquitos-May-Be-Released-in-Florida-Keys/384859/

http://e360.yale.edu/feature/genetically_modified_mosquito_sparks_a_controversy-in-florida/2883/

http://www.dw.com/en/fda-gives-nod-to-genetically-modified-mosquitoes/a-19112519

http://time.com/4258317/fda-genetically-engineered-mosquito/

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Approval Near for GM Three Parent Babies

Posted on 03 March 2014 by admin

Now the FDA in the U.S. has joined the U.K.’s Human Fertilisation and Embryology Authority in being very close to approving trials of human genetic modifications that would create three parent babies.  Both countries have formal and informal rules that forbid germ-line modification where embryos have their DNA modified and the alterations can be passed on to future offspring.

Fortunately, even if the Authority in the U.K. approves the trials, the issue will have to be debated and approved by Parliament before it can move forward.  This is not the case with the FDA in the U.S.  FDA approval is the only requirement to begin the trials.

Many ethicists believe this is the beginning of a trend toward designer babies.  This is where prospective parents decide what characteristics they want their offspring to have and genetic modifications are made to order.

In an August 2013 post entitled Chimeras for Transplant and Third Parent Immunity, we raised the issue of genetic modification of a woman’s egg with genes from a second woman’s egg with the resulting egg being fertilized by a man.  This was identified as the newest approach to protect babies where the biological mother had mitochondrial disease.

The framing of the proposal is that it allows a woman with mitochondrial disease to have children without any fear of passing on mitochondrial diseases.  This creates a very sympathetic public reaction.  Ethicists and geneticists point out however that no one knows what effects there will be on future generations from having the additional genes of the third parent.

According to Dr. Marcy Darnovsky, Executive Director of the Center for Genetics and Society in Berkeley, California, the concern is that the genes involved “have pervasive effects on development and metabolism.  And the permissive record of the UK regulatory authorities raises the prospect that inheritable mitochondrial changes would be used as a door-opening wedge towards full-out germ-line manipulation, putting a high-tech eugenic social dynamic into play.”

The fear is of unpredicted outcomes in the children whose genes have been modified or in subsequent generations of direct descendants.  Also, Dr. Darnovsky stated these trials would be “the first time a government body had okayed genetic changes for humans and their descendants.”

Even researchers who are generally supportive of the procedure have their doubts about proceeding to human trials.  An article issued by Reuters said that Dr. Evan Snyder of the Sanford/Burnham Medical Research Institute in La Jolla, California, who chaired one of the committees queried by the U.S. FDA, said “there was probably not enough data in animals…to move on to human trials without answering a few additional questions” about safety.

The United States has a long history of supporting genetic engineering and modification.  This would be its first experiment approved with human beings but the precedent has been set with its long history of approving and giving worldwide support to genetically modified plants and crops.

The FDA’s support has typically benefitted the U.S. agribusinesses that have commercialized these products and have strong lobbies.  It appears there is not an organized lobby that would put pressure for approval of these trials.

For this reason, public pressure, domestic or foreign, might work to halt a positive decision to go ahead. I would recommend that readers who oppose germ-line modifications contact their congressmen or senators if they are U.S. residents.  Opponents, in other countries should send correspondence directly to the U.S. FDA at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 or call 1-888-INFO-FDA (1-888-463-6332).  Unfortunately, approval by the U.S. will be used as an example of ‘international competition’ to spur the UK to approve as well.

Use the following links to obtain more information or access the source documents for this article.

http://www.reuters.com/article/2014/02/25/us-usa-health-ivf-idUSBREA1o1WL20140225?feedType=RSS

http://www.sciencemag.org/content/343/6173/827.summary?sid=615fffda-ad98-4b10-abd6-bb0e21b55aee

http://www.sbs.com.au/news/article/2014/02/28/uk-seeks-public-input-3-parent-embryos

http://www.nature.com/news/a-slippery-slope-to-human-germline-modification-1.13358

 

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Genetic Engineering Influence Peddling and Profit

Posted on 13 June 2012 by Jerry

The world is full of influence peddlers with countless people on both sides of the transaction. There are the influencers with money, power, and prestige who tempt people around them to take actions which benefit the influencers to the exclusion of everyone else.  There are also those who are waiting to be influenced and act compliantly or at minimum turn a blind eye toward someone else taking advantage of a situation. They view their personal corruption by others as the most direct way for them to progress and prosper.  In their world every issue is a shade of gray rather than black and white.  There is always an argument to justify the most self serving answer of the moment.  These groups view the world as dog-eat-dog and view their personal prosperity and that of their interest group as all that matters.

There are an infinite number of angles that can be worked for personal profit and/or to facilitate influence peddling, too many angles to list and explain.  There are however, notable examples that garner public attention, outcry and deserve further elaboration.  This is certainly true in the areas of greatest opportunity where large amounts of money are being paid and where the corporate and venture capital consensus sees a future bonanza.  This is specifically true in genetic engineering of modified foods and in the field of synthetic biology.

The first example is of a very straight forward phenomenon, the movement of people back and forth between government and the corporations who wish to control government’s actions.  The case in point is that of Michael R. Taylor who was appointed by the Obama administration to be the Deputy Commissioner of Foods at the Federal Drug Administration (FDA) in 2010.  In this capacity, Mr. Taylor, an attorney by trade, is in charge of food safety in the United States.

To illustrate how influence peddlers groom their collaborators we look first at Wikipedia that gives a fairly straight forward description of Mr. Taylor’s background.  The Wikipedia article describes that after law school he went to the FDA as a staff attorney, then to a law firm where he led the firm’s “food and drug law” practice and represented Monsanto for many years.  Then he was appointed as Administrator of Food Safety and Inspection in the Department of Agriculture.  From there he went back to his prior legal practice where he was shortly named at Monsanto as the Vice President for Public Policy.  Then he went into academia as a Research Professor of Health Policy before returning to the government to become a “senior advisor” to the FDA Commissioner.  He held this position for a few years before Obama promoted him to his present position.

Compare this background description with the two press releases issued by the FDA announcing his appointment as senior advisor to the FDA Commissioner in 2009 and the announcement of his appointment as Deputy Commissioner for Foods in 2010.  In the 2009 announcement there is no mention whatsoever of his past affiliation with Monsanto.  In the 2010 document from the FDA there is one mention of Monsanto in the next to last sentence of the press release.

Lest you think these two press releases go out of their way to downplay, if not completely omit, description of Mr. Taylor’s Monsanto connections, you would be completely right.  Among the many WikiLeaks disclosed cables from within the State Department are a number of cables that reveal the full and explicit U.S. government support for U.S. chemical and agriculture business’ genetically modified foods.  It is particularly instructive to learn that the strategic policy of the United States is to support and promulgate genetically modified foods around the world as one of our most important exports.

In addition, we have two examples of descriptions of Mr. Taylor’s appointment to his latest position.  The article in the New York Times mentions his past affiliation with Monsanto only once in passing.  The corresponding article in the Washington Post is much more balanced and provides full disclosure of Mr. Taylor’s past affiliations with Monsanto and his support, while in government, for controversial Monsanto issues like not needing to label milk from cows that were given growth hormones.

Our next example received more public attention but unfortunately it was largely confined to the European Union.  Such is the case of Diána Bánáti who was the unpaid chairwoman of the management board of the European Food Safety Authority (EFSA), the European Union’s top risk assessment body.  She concurrently held the salaried food safety commissioner and chief scientific advisor positions at the Hungarian Ministry of Rural Development.  As reported in the cited article, Ms. Bánáti was asked to resign from both positions when she announced she was being appointed as the executive and scientific director of the Brussels based International Life Sciences Institute (ILSI). 

Previous controversy surrounded Ms. Bânâti when it was discovered that she had not disclosed an earlier appointment to the ILSI’s Board of Directors before her last re-election to the EFSA Board.  After her ILSI Director appointment was disclosed she was forced to give it up so as not to jeopardize her position as EFSA chair.

Her new position was possibly recognition for a job well done at the EFSA.  Within a few weeks of her resignation, the European Food Safety Authority rejected a French Government attempt to ban a genetically modified strain of corn developed by the U.S. based Monsanto Corporation.  The rejection is now slated to go for decision to the European Commission for ratification or rejection.

While not going to work directly for a chemical or agriculture business, her move is a variation of the revolving door that Michael Taylor is using.  The ILSI is an industry funded think tank. Its membership list is a who’s who of the agriculture, food and chemical industries world-wide. 

Our final two examples are in the area of synthetic biology and represent a different gambit to achieve personal profit.  This involves concurrent leadership of non-profit research institutes and venture capital backed private businesses.  One can suspect that this puts a scientist entrepreneur in the position to use government grants and nonprofit status to conduct research in a promising area and then redirect the research into their own startup when they think a scientific breakthrough is eminent.  In at least one of these situations, we see the entrepreneur hedge his bets by having his private company fund the research in his own research institute.  This would appear to be a way to limit argument about who owns the science that is developed.  The entrepreneur sits at the key pivot point and is in a position to choose where, how and with whose money to conduct ongoing breakthrough research.

While this is happening, selected individuals in the scientific community, governmental departments or grant making nonprofit organizations at a minimum turn a blind eye to what may be happening.  This is because they can argue that the research needs to be done no matter how it is accomplished or who benefits.  A cynical assessment is that these people are hoping for future positions in one of the organizations, stock options of the private companies or the favors of the scientist entrepreneur helping them pursue their own future opportunities. 

To see this organizational structure consider J. Craig Venter who on the nonprofit side heads the J. Craig Venter Institute “with more than 300 scientists and staff”.  This Institute was assembled by the merger of several of Craig Venter’s earlier organizations, specifically The Institute for Genomic Research (TIGR), The Center for Advancement of Genomics, The J. Craig Venter Science Foundation, The Joint Technology Center, and the Institute for Biological Energy Alternatives.  On the for profit side, Craig Venter leads Synthetic Genomics, a high tech synthetic biology private startup funded in part by Draper Fisher Jurvetson, BP, the Meteor Group, Biotechonomy LLC and Plenus, S.A. de C.V.

Another example of this dual nonprofit and for profit structure is that assembled by Steven A. Benner.  On the non-profit side, Benner heads The Westheimer Institute of Science and the Foundation for Applied Molecular Evolution (FAME).  On the profit side, he leads private startup Firebird BioMolecular SCiences LLC.  He sold another private company, EraGen Biosciences, to Luminex.

As a side note, synthetic biology as expressed in earlier posts creates significant risks if you assume there is a potential for release of a synthetically created organism outside the laboratory.  Apparently Firebird Biomolecular Sciences, LLC, agrees.  It posts a disclaimer that reads “All products sold by Firebird Biomolecular Sciences LLC., are for research and development purposes only, and are not for use in humans.  It is the responsibility of the buyer to determine the suitability of the product for any given purpose.  Products should be handled by trained personnel who understand the potential hazards of working with such materials.  Responsibility for accidents arising from the handling and use of Firebird products rests solely with the buyer.”  While approving of the warning, it would be great if it was this easy to insulate one’s company and one’s self from future lawsuits and responsibility.  

As has been observed in previous posts, the world’s largest chemical and agricultural businesses are pushing, with the U.S. government’s help, the adoption of genetically modified foods throughout the world.  At the same time, scientist entrepreneurs looking to benefit from synthetic biology are arguing aggressively and successfully there should be no government oversight or intervention in synthetic biology. 

Citizens around the world must be cynical as they consider what is happening in their governments.  They must examine every appointment to high government position and identify the biases these individuals bring with them.  They must be vigilant about the present positions their governments are taking on issues surrounding our ozone, climate change, nuclear weapons and genetic engineering and synthetic biology.  They must identify influence peddling for what it is and marshal public opinion against it.

Use the following links to obtain more information on these topics:

Michael R. Taylor:

http://en.wikipedia.org/wiki/Michael_R._Taylor (Select “search for Michael R. Taylor in Wikipedia.”  You will see a message saying there is no listing for Michael R. Taylor.  Select the first Taylor option offered and you will go to the page)

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm170842.htm?utm  

http://www.fda.gov/food/newsevents/constituentupdates/ucm197828.htm?utm

http://www.theatlantic.com/health/print/2011/01/us-presses-europe-to-worship-genetically-modified-foods/69633

http://www.rodale.com/genetically-modified-organisms-foods-0

http://www.nytimes.com/2010/01/14/health/policy/14fda.html

http://www.washingtonpost.com/wp-dyn/content/article/2010/01/13/AR2010011304402.html

Diána Bánáti:

http://news.sciencemag.org/scienceinsider/2012/05/european-food-safety-official-re.html

http://www.europeanvoice.com/article/2012/may/eu-rejects-french-gm-ban/74415.aspx

http://phys.org/news/2012-05-eu-food-agency-france-monsanto.html

J. Craig Venter:

http://dnalc.org/view/16830-Biography-39-John-Craig-Venter-1946-.html

http://edge.org/memberbio/j_craig_venter

http://www.syntheticgenomics.com/about/

http://www.syntheticgenomics.com/about/genesis.html

Steven Benner:

http://www.westheimerinstitute.org/about.php

http://www.gtecflorida.com/tech_industry-GTEC_start-ups.aspx

http://www.ffame.org/sbenner.php

http://www.firebirdbio.com/index.html

http://www.firebirdbio.com/AboutUs.html

Presidential Bioethics Panel:

http://www.nytimes.com/2010/12/17/health/17synthetic.html

To see the text of the report from the Presidential Bioethics Panel, select “the report” in the first line of the second paragraph of the NY Times article listed above.

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