Archive | Genetic Engineering

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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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Are There Cracks in the GM Armor?

Posted on 19 October 2013 by Jerry

Below the surface there are cracks in Monsanto’s armor and storm clouds threaten its future.  If we only look at Monsanto’s results for 2013 things are going great.  Sales are up to $14,861 billion while gross profit and net income are at $7,653 billion and $2.482 billion respectively.  Their total seeds and ‘genomics’ (genetically modified products which includes almost all seeds) generated $10,340 billion.  In addition, Monsanto hired the new lobbying firm, the Lincoln Policy Group, of ex-Senator Blanche Lincoln, who for two years was the chairwoman of the Senate Committee on Agriculture, Nutrition and Forestry.

But 2013 was not as positive as it seems.  Events in the European Union have been so negative that Monsanto has announced it will no longer seek approvals for its GM crops in the E.U.  Activists and governments continued to block approval of Monsanto’s applications for genetically modified crops.

While the European Food Safety Authority (EFSA) has deemed eight genetically modified crops as safe beginning as far back as 2005, they and five other crops are still under study and have been effectively blocked.  European governments have stopped implementation of the EFSA’s approved crops due to political pressure of activists and continued scientific disagreement.  Monsanto announced instead that its focus in the E.U. would be on its traditional seed business.

Also reflecting the rejection of GM products in the E.U. in 2012, BASF Plant Sciences announced they would abandon the development and sale of their European Union product Amflora.  Amflora is a high starch GM potato designed for industrial applications like the production of paper.  BASF instead moved their development and sales resources for this product to a much more supportive United States.

Indicative of the hostility to GM products in the E.U. the Swiss government has announced it will create a permanently protected federal research area for genetically modified crops.  This is to help control the increase of vandalism and the costs it is experiencing.  It is estimated Swiss GM researchers spend 78% of their research funds on security.  Because of this, the government approved an annual expense of €600,000 (~$822,000) for a secure field test site of approximately 3 hectares (~7.4 acres).  In 2008 masked activists threatened researchers and destroyed about 1/3 of the GM plants grown at another location.

Even in the U.S., the home of genetic engineering and the biggest crops from GM grains, there are signs of eventual labeling of GM crops.  Connecticut became the first state to pass legislation requiring labeling of GM foods.  Unfortunately, given the small size of the state, the bill only goes into effect after a number of other states in the Northeast follow suit.

Almost half of the  states have introduced legislation or ballot initiatives requiring mandatory labeling.  The biggest battle that is raging is in the state of Washington where once again the GM industry has brought its big wallet to the fray.  So far opponents of the legislation, the GM industry, have raised over $17 million compared to the $5 million raised by the backers of the initiative.  We will know how this initiative fares by the end of the year.

While labeling is being hotly contested in the U.S., labeling requirements have been embraced by over 64 countries in the world.  These include Australia, Brazil, China, Japan, South Africa, South Korea, and all of the countries of the European Union.  We can only hope the GM crop industry decides its state-by-state approach is too costly.

Rumors abound about secret negotiations at the federal level.  President Obama committed to mandatory labeling of GM food in his second term.  This commitment will require we hold the Obama Administration’s feet to the fire to require legislation with real teeth to accomplish the labeling.  Toothless legislation is the House and Senate’s tradition when big business is involved.   This continues the uphill struggle.

Use the following links to obtain more information on these topics or to see source documents.

http://news.monsanto.com/press-release/financial/monsanto-delivers-third-consecutive-year-strong-growth-performance-global-po

http://www.huffingtonpost.com/2013/10/16/monsanto-blanche-lincoln-_n_4110750.html

http://www.nature.com/news/monsanto-drops-gm-in-europe-1.13432

http://www.huffingtonpost.com/michele-simon/junk-food-lobbyists-sued_b_4104046.html

http://www.centerforfoodsafety.org/issues/976/ge-food-labeling/state-labeling-initiatives

http://www.kansascity.com/2013/10/17/4558314/will-washington-state-break-us.html

 

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Chimeras for Transplant Organs and Third Parent Immunity

Posted on 13 August 2013 by Jerry

How you feel about something may be a function of how broadly you generalize or how narrowly you define it.  We have two scientific situations that specifically sound positive and yet generally may set disturbing precedents.  Each of us should decide how general we think we should be, what are the downsides and who determines outcomes.

In Japan there is a partial governmental ban on experiments that create chimeras, or mix human cells with cells of other animals to create cross species hybrids.  Creation of chimeras is permitted in vitro, a test tube or petri dish involving just cells, for up to fourteen days after which the resulting cells are destroyed.  No experiments are permitted in vivo, or with a whole living organism.

It is just such a whole living organism experiment that has been proposed by Dr. Hiromitsu Nakauchi, a stem cell biologist at the University of Tokyo.  He believes he can grow human organs in a pig fetus by implanting human pluripotent stem cells into a genetically engineered pig fetus that lacks a specific organ.

An article appearing in the June 28, 2013 issue of Science magazine states “Mouse experiments have shown that pluripotent cells can fill the developmental niche opened by the absence of an organ.”  Dr. Nakauchi believes he can eliminate the fear of organ rejection by using the recipient’s own pluripotent cells to be grown in the pig.  After the piglet is born, when the organ is the right size, it would be harvested and transplanted into the human being.

While having received a Japanese government ethics panel endorsement, Dr. Nakauchi will probably wait no longer.  He has just been awarded a $6.2 million grant from the California Institute for Regenerative Medicine and is in discussions to open a new lab at Stanford University.  The California Institute for Regenerative Medicine was formed when voters in the state approved a 2004 ballot proposition providing $3 billion of taxpayer funding for stem cell experimentation.

A different proposal has been approved for trial in the United Kingdom.  It involves a strategy for avoiding a baby inheriting mitochondrial disease from the genes of its biological mother.  The strategy is to merge the nucleus of an egg from the affected mother with the egg of another woman who has no genetic anomaly and then have the merged egg fertilized by the sperm of a man.  This would produce a baby that genetically has three parents but does not develop mitochondrial disease.

The worldwide controversy surrounding this experimental procedure is that it would allow the baby to pass on its altered genetic code to its eventual offspring.  This means the change created by the merged eggs constitutes genetic germline modification.

Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, California, in a July 17, 2013 issue of Nature magazine states “Were the United Kingdom to grant a regulatory (permanent) go-ahead, it would unilaterally cross a legal and ethical line on this issue that has been observed by the entire international community.  This consensus holds that genetic-engineering tools may be applied, with appropriate care and safeguards, to treat an individual’s medical condition, but should not be used to modify gametes or early embryos and so manipulate the characteristics of future children.”

In both of these cases the specifics, especially given the targeted outcomes, clearly offer benefit, if successful, for thousands of people.  Issues arise however, when what happens in the experiments is generalized to permit a host of other experiments with far less compelling outcomes or even risks of serious harm.

These experiments should cause each of us to personally consider what kind of genetic engineering should be allowed.  A series of questions come to mind.  For instance, should the applied science of genetic engineering continue to be largely unregulated?  Should exceptions be made and by whom?  Whom should we appoint to sit in judgment and make decisions for us?  How will those we appoint represent us faithfully and how will they know what we collectively think?  These scientific issues may have a profound effect on our collective future.  They deserve our personal attention.

Use the following links to obtain additional information or see original source documents:

http://www.sciencemag.org/content/340/6140/1509.sumary?sid=ad66cb5e-78e1-449d-936b-79d2d5e8e5a1

http://news.sciencemag.org/health/2013/03/u.k.-agency-cautiously-endorses-mitochondria-replacement

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

http://www.the-scientist.com/?articles.view/articleno/34790/title/uk-may-allow-mitochondrial-replacement

http://www.guardian.co.uk/science/2012/jan/05/chimera-monkeys-combining-several-embryo

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Genetically Modified Sexual Aptitude

Posted on 02 June 2013 by Jerry

Comparison between genetically modified and natural salmon.

Comparison between genetically modified and natural salmon.

Scientists are afraid of a genetically modified new species that disrupts the natural ecology by crowding out and starving competing species.  One that grows faster than a wild organism, becomes bigger and breeds indiscriminately spreading its aggressive characteristics.

Rather than promoting diversity which science shows is good for evolution, it significantly reduces variety.  It increases ecological dependency on a single species creating greater risk if something were to happen to that newly dominant species.  This is how we have population crashes of a species and the collapse of its ecology.

This risk, the viability of the fishing industry, and human health are major reasons over 59 retailers selling natural fish in over 4660 stores announced they will not sell the genetically modified AquAdvantage® Salmon even if approved by the Federal Drug Administration.  These grocery chains include well-known companies such as Target, Whole Foods, Trader Joe’s, H-E-B, Giant Eagle, and Meijer.

These and other retailers are now also reacting to a new Canadian study recently released by the United Kingdom’s Royal Society.  Reporting that AquAdvantage® Salmon easily breed with brown trout and they also show the salmon hybrid’s “competitive dominance” over other, natural, brown trout.  This would indicate that both natural brown trout and Atlantic salmon are at risk of declining stocks due to this aggressive genetically modified hybrid.

While AquaBounty, the company responsible for the GM fish, indicates it will only raise sterile fish even the FDA admits that up to 5% of the fish will be fertile.  When discussing future large-scale production, which AquaBounty hopes represents millions of fish, this 5% will be tens of thousands of fertile fish.

We have been following the AquAdvantage Salmon developments in various posts on this blog for months.  The significance of this salmon is that if the FDA approves it for human consumption and sale, which appears likely, it will be the first genetically modified animal to itself be introduced into the food supply.  All previous genetically modified foods have been largely plants that have been mainly modified to be impervious to various manufacturer’s herbicides or pesticides.

There is high certainty that if this fish is approved, many other genetically modified animals for which FDA approvals will be sought will follow it rapidly.  Besides concerns there is no labeling requirement to identify these GM foods, the FDA unfortunately is in dire need of a significant updating and modernization.  The FDA is today operating under animal drug requirements designed for the testing and regulation of feed additives and animal vaccines.  Their required testing is not designed to study the long-term effects of human consumption or the ecological damage that genetically modified animals can cause.

The present reality of genetically modified foods, plant and animal, must be recognized.  The long-term ramifications to our ecology and health must be studied before further GM organisms are taken out the lab and introduced into our food supply and environment.  The risks are too big and far-reaching to not be studied.  While not popular with businesses, environmental impact assessments in other situations protect the environment and human populations.  A comparable study methodology must be imposed on these newly proposed GM products.

Use the following links to obtain further information:

http://www.foe.org/news/blog/2013-05-no-room-on-our-plates-for-genetically-engineered-sea

http://www.foodandwaterwatch.org/blogs/ge-salmon-the-promiscuous-fish-who-knew-not-the-fda/

http://rspb.royalsocietypublishing.org/content/280/1763/20131047.full.pdf+html

http://www.guardian.co.uk/environment/2013/mar/20/major-us-supermarkets-boycott-gm-salmon

http://www.mlive.com/business/west-michigan/index.ssf/2013/05/meijer_joins_major_retailers_i.html   

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Businesses Join the GM Labeling Fight

Posted on 06 May 2013 by Jerry

We could be cynical about Whole Foods declaring it will require all its suppliers to label products that contain genetically modified ingredients by 2018.  We could be skeptical, if it weren’t so exciting and part of a larger trend of businesses weighing in to protect their interests.  We could see the Whole Foods announcement, known for its “organic” products, as just moving closer to their customers, who have been lobbying the chain to get involved.  On the contrary however, we see it as potentially a historic turning point in the U.S.

The Food and Drug Administration is rumored to be about to approve genetically modified salmon developed by AquaBounty for sale in U.S. stores (see an earlier post on this blog).  This would be a major milestone since it would constitute approval of the first genetically modified animal to enter the U.S. food supply.

This development threatens the natural salmon fishing industry in Alaska and elsewhere.  It has prompted many more businesses to join the anti-GMO ranks.  Trader Joe’s and other grocery retailers representing more than 2,000 stores have announced they will not carry the GM salmon if it is approved for sale.

The prospect of GM salmon has led to the introduction of federal mandatory labeling legislation, the Genetically Engineered Food Right-to-Know Act.  This unites mandatory labeling forces with the fishing industry to continue the fight.  Sponsors of the legislation include U.S. Senators from California (Barbara Boxer), Alaska, New York, and Vermont and House Representatives from Alaska, Oregon, Maine, New York and Washington.

This is not to say the other side of the labeling debate has not been lobbying for its positions.  Quiet meetings between the FDA and pro-GM forces are reported to have taken place as companies lobby for neutered and watered-down labeling requirements that pre-empt the states.  Companies participating in these meetings are said to include behemoths such as Wal-Mart, Coca-Cola, General Mills, Pepsi-Frito Lay, and Mars.

State legislation and ballot measures have not yet been successful other than in Alaska where legislation has passed calling for the mandatory labeling of genetically modified salmon. While state labeling bills are still pending in Connecticut, Missouri, Vermont and Washington state, legislation in New Mexico was allowed to die on the state senate floor.

Ben & Jerry’s Ice Cream also announced it would commit to sourcing non-GMO ingredients for all of its products everywhere by the end of 2013.  They also stated they would transition packaging so all products will be labeled with respect to GMO by the end of 2014.

While owned by international conglomerate Unilever, the terms of its sale required a measure of ongoing independence of a separate subsidiary board of directors unusual to corporate acquisitions.  In addition, some would argue this is not a big deal because of the small size of the B&J product line, that 80% of its ingredients are already non-GMO, and that mandatory labeling is required in the E.U. and U.K.

The U.S. government defines the use of the word organic on a label.  Amongst other things, it identifies products that do not have GM ingredients.  People concerned about the healthiness of their food have a history of paying more for this organic assurance.  Whole Foods has a net profit margin approaching 4% that is more than twice as big as the less than 2% net margin of average retail/wholesale food grocery stores.

Because labeling is a worldwide issue and complex, the identified links below provide additional information.  At present there are 64 countries identified as having mandatory GMO labeling requirements (see below).

For those people looking for a way to be involved or to impact this labeling issue in the U.S. I suggest you put personal pressure on the businesses with which you do business.  We need to learn from the effectiveness of people who lobbied for a change of policy at Whole Foods.

In addition, you should go to www.justlabelit.org.  While hundreds of organizations have declared support for mandatory labeling, Just Label It has become a focal point for individual involvement and grassroots lobbying of elected officials.  I am convinced they are one of the most effective points of entry today.

Use the following links to obtain more information:

http://www.wholefoodsmarket.com/node/199961

http://articles.washingtonpost.com/2013-03-15/business/37731461_1_gmo-organic-ingredients-food

http://news.msn.com/science-technology/whole-foods-others-to-shun-genetically-modified-seafood

http://www.foodsafetynews.com/2013/04/bill-introduced-in-house-and-senate-to-require-labeling-of-ge-foods/

http://readersupportednews.org/opinion2/448-farm-and-food-policy/15491-why-are-wal-mart-and-big-food-lobbying-the-fda-for-a-gmo-labeling-law

http://www.organicconsumers.org/articles/article_27182.cfm

http://www.allaboutfeed.net/process-management/management/2013/2/us-washington-state-to-vote-on-mandatory-gm-labelling-1166691w/

http://www.bizjournals.com/albuquerque/news/2013/02/01/gmo-food-labeling-bill-voted-down.html

 

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