Tuesday, October 7, 2014

GMO junk science meets junk journalism


The debate about gmo safety is over! 




At the beginning of September, I met Kevin Folta, a plant scientist- who has taken an active role on the internet educating the public about  GMOs.. We talked about GMOS science over lunch and as the scientist was getting ready to leave  mentioned that a new study was about to be published on GMOs involving BILLIONS of animals. BILLIONS of animals!

-- I couldn't even imagine the reams of paper required to assess the health of BILLIONS.
 But....within a day the study popped up on Twitter and the charade began.

As it turned out the new data fit on just a few pages.

The author.
What happens when 100 billion animals, over 18 years, eat GMOs? http://t.co/GScfLlbhhc via @GeneticLiteracy

Looking under the hood of the billions of  animals  chickens  clunker  study







Industry
1
United States
94,683,600,000
Layer Hens
3,722,708,000




The fist thing to note is what the author actually means by "100 billion animals"

94.7% or  94,683,600,000 of the 100, 000,000,000  are broiler chickens, which the author doesn't disclose for 37 pages (Table 3) and neither does the media echo-chamber. 



Broilers


This is poultry whose natural lifespan is about 5 years, slaughtered at less than 49 days of age. So, even if the study reported convincing health data, it would remain a very short term study. In other words, it is 19 years-worth of 49 day old chickens, which is quite different than 19 years of life-long animal studies.

The "study" is a hodgepodge of livestock production data  used to bolster the safety alleged from a literature review. The rest is  polemics on international harmonization, with a particular emphasis on Ukraine. The author is making a case for "harmonization" -- actually, code for take-over of Ukranian agriculture by international corporations- Monsanto, Dupont, Cargil 
--concomitant with  the relaxation of already outrageously unacceptable, crude and  inadequate safety testing standards.

The author recommends elimination of the 90-day rodent feeding trials- described  as "interference in risk assessment based on pseudoscience",  as well as  the long-term studies  " due to additional time, expense and animal experimentation." .


Health  Livestock production data on billions of chickens. 

What one expects to see in animal health studies



The "data" for nearly 95% of the "animals"  summarized in Table 4 and  Figure 2 reported by the Chicken Council- a poultry industry trade group- hardly a source of medical quality scholarship.

 here: http://www.nationalchickencouncil.org/about-the-industry/statistics/u-s-broiler-performance/


Unsurprisingly, what I actually found

  • days to market
  • feed efficiency (feed to grain ratio)
  • percent mortality
  • carcass weight


Poultry statistics are used to prove the following hypothesis:  " It would be reasonable to hypothesize that if animal feed derived from GE crops had deleterious effects on animals consuming GE feed, then animal performance and health attributes in these commercial livestock populations would have been negatively impacted" 


  •  Firstly, livestock performance is not a marker of health- because the goal of livestock production is minimizing inputs and maximizing production of meat, eggs or milk regardless of costs to the animal's health or longevity.  For the rest of us, who aren't slaughtered at 49 days, the goals are completely different.
  • Interestingly, if one were to literally assume that GMOs lead to improved feeding efficiency- as is seen  in poultry statistics- grossly extrapolating that hypothesis to humans and pets, we could attribute the obesity epidemic to GMOs.     But since the traits aren't segregated, if  a particular crop reduced feed efficiency it would go undetected.  
  • An example of this is high oleic GMO soybeans produced by Dupont  reported to  reduce feed efficiency  ( J. Heinemann, personal communication) Was it included in this data set?  -Who knows! So we can't say that GMOs improve feed efficiency as a category, because some traits actually reduce it, Each  needs to be evaluated individually- rather than be lumped into a giant category of GMOs as was done in this study which presumably compares livestock production data for the entire herd "before GMOs"  to "after GMOs", as articulated in the "hypothesis" below. 

  • Beyond wishful thinking, the author doesn't convincingly explain how  these exceptionally limited parameters encompass  health. Health is measurable with medical tests (bloodwork, microbiology, imaging such as X-rays,  biopsies/ histopathology), but no medical tests are cited in this "study" 
  •  Irrelevant, indirect data is missing for meager livestock parameters-- and there is no medical testing or medical data of any kind permitting assessment of overall animal health.

  • Joint disease is common in poultry, for example, because of selection for growth--but would be devastating for humans.
It should be  intuitively obvious by now that  even if  medical tests were reported--wholly absent from this study they are entirely meaningless to any animal other than a 49-day old  broiler chicken, never mind a human. And there are reasons chickens aren't EVEN used in preliminary testing of effects of substances on humans--they are a very poor model for human health.



The remaining 5% of the animals in the data set are dairy cattle and beef cattle. The authors cobbled  together arbitrary unrelated data -somatic cell counts, and  condemnation rates,  from  disparate sources,  and when data wasn't available-simply made it up.

Page 11 states " data on cattle condemnation rates were available for 1999-2002.

Data for 2003-2007 is based on FOIA.

Data for 1994 (before GMOs)  was collected  from National Non-Fed Beef Quality Audit--but these animals do not spend  time  in  feedlots and so are pasture raised and aren't fed GMO corn and soy.

Data was unavailable for cattle before GMOs were introduced, so the authors fills in a 22 year gap with  regression analysis  -a projection- for 11 years (1983-1994) before GMOs were introduced, as well as for 11 years  (2000-2011) after. Since there was no data for cattle for 1983-1994 or 2000-2011, claims that this study examined parameters for 19 years is a lie.

The only definitive data was for 1999-2002, even if condemnation rates were associated with animal health, but they aren't. Speed of slaughter lines and the number of assigned federal meat inspectors whose numbers have been dwindling. affect condemnation rates which do not substitute for proper post-mortem analysis with histopathology.

Somatic Cell Counts  --indicator of mastitis-breast infection in dairy-are reported for a 1995-2011, thus, there is no data "before GMOs" and condemnation rates for 1998-2006, after the introduction of GMOs.  Moreover, SCC can't differentiate mastitis due to good/ poor animal health resulting from impacts of GMOs  on health from  hygiene,  milking equipment sanitation or antibiotic use. These confounding factors make the association of this test with GMOs spurious.


  •  Milk yield and SCC certainly  do not reflect the animal's overall health  indirectly indicated by longevity, since dairy is culled at 4-5years of the age of a 15-year normal lifespan. One most certainly can't use milk parameters for  males who don't produce milk at all.
  • The hypothesis that milk production encompasses health is unreasonable and  is not backed up by scientific evidence. Additionally, confounding factors weren't segregated out, so it's hard to attribute these limited livestock parameters to GMOs. Clearly, milk tests do not evaluate the function of the metabolic organs-kidneys, liver, pancreas, the endocrine system, GI tract, bone marrow, the musculoskeletal system  or the immune system any organ outside of mammary glands. 
  • MILK TESTS OMIT HALF THE POPULATION- MALES, WHO DON'T MAKE MILK
  • EXTRAPOLATION FROM LIVESTOCK TO PETS OR HUMANS IS OUTRAGEOUSLY UNSCIENTIFIC

Meanwhile, veterinary health data has been collected by the FSIS and it shows remarkably high rates of malignant lymphoma in livestock

But appropriate data was only collected for five years:  1998-2002. So there is no long-term data useful in analyzing long- term impacts of GMOs on livestock health. 



Hypothesis

Most of the text focus is on  international trade rather than science- more appropriate for The Wall Street Journal or Forbes, rather than a peer-reviewed journal.

A Hypothesis is conventionally articulated in the abstract, expanded in the introduction, and the remainder of a journal article usually describes materials and methods  used to prove the hypothesis. Then, we expect to see results and an explanation of results in the discussion section.

None of these are found in this study- the Methods and Materials section doesn't exist, while the hypothesis itself is hidden on page 10 of the introduction: " It would be reasonable to hypothesize that if animal feed derived from GE crops had deleterious effects on animals consuming GE feed, then animal performance and health attributes in these commercial livestock populations would have been negatively impacted"



Given the glaring gross science  ineptitude,  promotion of  exceptionally poor scientific standards, the obvious bias and  explicit agenda to force GMOs into war-torn Ukraine & European Union, I felt reading the author's lengthy science illiterate opinion on GMO safety literature to be a  complete waste of  time.

Quite unsurprisingly- the body of solid work by Manuella Malatesta  demonstrative of hepatic and pancreatic harm by GMO soybeans, which were reversible on cross-over analysis,  were dismissed- while  flawed studies and a flawed review (Snell et al) that purport not to show harm were accepted.

 The Snell et al review cites  Monsanto's own  short-term studies  actually suggestive of  kidney and liver harm induced in rats in under 90 days, as well as other studies reporting kidney damage and other forms of medical harm caused by GMOs.


Livestock health has improved since the introduction of genetically engineered crops...TRILLIONS of meals show no harm to animals or humans!



There is no precedent for using  livestock production as a proxy for animal or human health--an outrageous claim--but so what--Tweeterverss explodes in a convulsion of GMO celebrations.


Livestock health has improved since the introduction of genetically engineered crops. http://t.co/zfGjzFcoXa #GMO





The hype circled the globe reaching Russia within ten days.

Conclusion
This study purported to show lack of harm from GMOs to billions of animals-  majority of whom were 49 day old chickens-- while the GMO propaganda machine wildly exaggerated this substandard pile of bovine manure to also mean lack of harm to people- even though he study doesn't cite any traditionally accepted medical tests employed to evaluate animal or human health.

The author bound arbitrary, incongruent  livestock production data with spit, bailing wire and zip-ties,  to arrive at a predetermined conclusion that GMOs do not cause harm bound with an explicit hypothesis on"harmonization" of Ukraine (with our embarrassing junk science standards) that are oh, just coincidentally  made possible by overthrowing a democratically elected sovereign government and installing friends of Western Corprations--Monsanto, Dupont, ConAgra grabbing prized black Ukranian Farm Land.


Ukraine has historically been Russia's bread basket. Russia criminalized the sale of  unlabeled GMOs imposing a ban on their cultivation. Meanwhile, the new Western-imposed junta government in Kiev hurriedly passed laws to ease entry of GMOs into Ukraine, as well as using it as a backdoor into Europe. While Ukraine is in the midst of a civil war, it is a perfect target for deregulation of GMOs, which the author expresses cloaked in the language of "harmonization".

















 



Friday, April 4, 2014

Alert: Round Up Ready GMO might be causing bladder & kidney stones

Do you want high-tech help for your pet who can't pee? 

Can you afford it? Can your cat and dog?  If you answered no, please read ingredient labels






Stubborn Stones


Sometimes, just like humans dogs and cats develop urinary stones. 

A few months ago we saw a case we think is worth sharing--a cute little 5-year old pooch with two stones wedged inconveniently in the urethra overlying the os penis, a rod-like bone structure within the penis of male dogs (see X-ray below ).  


While veterinarians can remove bladder stones via routine surgery--it's a different story with blockages of the urethra- the tube through which urine empties the bladder. 

Obstruction of the urethra presents a life-threatening emergency.  If the animal can't void it becomes rapidly intoxicated by the waste products remaining in the blood stream, causing build up of acid, potassium, and urea- leading to a painful death.

Urinary Obstructions are most often seen in male dogs and cats since the male urethra is longer and narrower than females' though we have seen females with a urinary obstruction (rarely) too. 

Some breeds, dalmatians, have a genetic predisposition to stone formation, and infections can lead to struvite (Magnesium Triple Phosphate) stones.   And yet other stones form for reasons we don't understand--the most common in cats and dogs (as well as people) being calcium oxalate

Here is a good overview on calcium oxalate stones by VCA Animal Hospitals and we will offer more insight VCA veterinarians aren't aware of below. 


Wait, what? We can we get kidney stones from oxa-what?   


 

 "What are Urinary Stones? What is Oxalic Acid and Oxalate?" Check out this link




And now,  let's get back to our lovable and very miserable  patient.





The first stone dissolved nicely with antibiotic plus acidification therapy and the dog passed it.  The second stone, unfortunately, wouldn't budge with multiple catheterization procedures performed to flush the stone back into the bladder, where it could be surgically retrieved. The poor dog's quality of life was becoming rather lousy-- living with a constant burning sensation is miserable, not to mention dangerous.



The dog's luck was starting to run out as we considered "turning him into a girl"--performing surgery ( perineal urethrostomy ) to bypass the penis. The trouble is that a newly created "vagina" often increases the dog's susceptibility to chronic urinary tract infections, not to mention is invasive and painful. 

Fortunately, for our little patient the owners were happy to drive him up to U.C.Davis Veterinary Teaching Hospital, where veterinarians have refined laser lithotripsy. ,   a procedure in which a tiny fiber-optic camera contained within a urethroscope or endoscope is used to visualize and guide a laser to pulverize the stone ( shown in the ureteral lithotripsy link).

Here is the before image of the stone within the urethra. It's pretty obvious why we had such difficulty budging it. Ouch!



Urethral stone before lithotripsy




Laser Lithotripsy to the rescue!

And here is AFTER lithotripsy





Laser blasts evaporated the stone, and the little dog was done with pain and straining as soon as he woke up,  minus invasive and painful surgery. Yay! What a relief!


Why reading food ingredient labels is crucial


 But you are a GMO watcher. How does any of this relate to GMOs?

Round Up Ready corn, soy and beet pulp from GMO sugar beets are in pet foods


The items underlined in red on the pet food label are most likely genetically modified (GMOs). They have been sprayed with Round Up- a proprietary formulation of glyphosate with other ingredients
The image isn't posted to pick on any dog food company. Iams is just one of numerous examples of popular widely available pet foods containing these ingredients. 

Beets are in many common pet foods. In addition to beets naturally being very high in oxalate, Monsanto genetically modified them (GMO) and they are sprayed with Round Up.

Glyphosate-containing herbicides are applied in large amounts to crops 2 to 3 times per season to remove weeds and dry out grain in a process called ‘desiccation’ [22]. Once applied, glyphosate accumulates in leaves, grains or fruit. Glyphosate residues cannot be removed by washing and they are not broken down by cooking [23]. Glyphosate residues can remain stable in foods for a year or more, even if the foods are frozen, dried or processed

Round Up (glyphosate) isn't just an herbicide; it's also an antibiotic.

 

 Monsanto patented formulations of glyphosate with oxalate as an adjuvant for its herbicides, and farmers are spraying it in exponentially increasing amounts on GMO crops.

Even though we eat oxalate in foods like kale, beets,  and spinach, intestinal bacteria like Oxalobacter formigenes degrade it, so less is bound to calcium and is unavailable to make kidney and bladder stones. But studies show glyphosate inhibits beneficial bacteria, some of which might degrade oxalate.

 In other words, Oxalobacter formigenes helps to neutralize oxalate, thus preventing kidney stones. It isn't the only vital bacterium, as studies have shown inconsistent reduction in oxalate in people administered a proprietary probiotic called OxaDrop, that doesn't contain O. Formigenes-- which is why microbiome studies characterizing microbial diverstiy and phenotypic changes cause by glyphosate in animals are needed.


Veterinary Epidemiology of Cat and Dog stones

Veterinarians have long been puzzled by the increase in the incidence of calcium oxalate urinary stones in cats and dogs.

The increased incidence of calcium oxalate stones in pets suggests an environmental cause.


Snap. Try this link please: canine-and-feline-urolith-epidemiology 

Thanks Hannah for pointing out the broken link!




Calcium Oxalate uroliths are represented by green, whereas struvite is aqua blue.



http://www.nature.com/ki/journal/v83/n6/full/ki2013104a.html

Snap. The article moved here. 

Research shows that a recently identified bacteria (Oxalobacter formigenes) found in both animals and people, reduces oxalate absorption from the intestines-- thereby reducing risks of forming calcium oxalate kidney stones in people.

Clinical Investigation

Kidney International (2013) 83, 1144–1149; doi:10.1038/ki.2013.104; published online 27 March 2013

The role of Oxalobacter formigenes colonization in calcium oxalate stone disease

About 75% of urinary stones contain oxalate. As Oxalobacter formigenes is a Gram-negative anaerobic bacterium that degrades oxalate in the intestinal tract, we assessed the role of O. formigenes in oxalate metabolism by evaluating its intestinal absorption, plasma concentration, and urinary excretion [...] Our findings suggest that O. formigenes  lowers the intestinal concentration of oxalate available for absorption at constant rates, resulting in decreased urinary oxalate excretion. Thus, dietary factors have an important role in urinary oxalate excretion. The data indicate that O. formigenes colonization may reduce the risk of stone recurrence.

Glyphosate sprayed on Round Up Ready GMOs ---  patented as an antibiotic has been shown in several studies to suppress beneficial bacteria in animals.

I've spent months and lots of effort to find out if glyphosate also kills this fragile and vital bacteria, and I couldn't get a basic simple microbiological test from the biotechnology industry scientists to prove that it does not.

Given Agri-Chemical corporations' previous history of denying harmful effects of their products coupled with stonewalling and  refusal to do a very simple microbiological test--an MIC (minimum inhibitory concentration of glyphosate for this bacteria)
-- leads me to suspect that it does!





We know that glyphosate is primarily excreted in the urine and feces where it can adversely affect beneficial bacteria, as well as paradoxically cause antibiotic resistance.

Bottom line  message


-Studies show Glyphosate inhibits beneficial bacteria. -Beneficial bacteria like Oxalobacter formigenes help break down oxalate.-Breaking down Oxalate helps prevent kidney stones.-Monsanto adds additional Oxalate to their poison, Glyphosate, which I suspect kills Oxalobacter formigenes. -Adding unnecessary oxalate and unneeded, unlabeled antibiotics to our food will increase kidney stones.


 If your pooch is a breed predisposed to these stones -Shi Tzu, Lhasa Apso,  Bichon Frise- or your doctor diagnosed him with calcium oxalate urinary stones-the Precautionary Principle dictates avoiding Round-Up Ready crops.  Do not buy pet foods with GMO corn, soy, beet pulp, as they are likely  to have been engineered to be Round-Up ready, and sprayed with glyphosate plus other undisclosed ingredients. 


Thanks to @farmfairycrafts  for your wonderful suggestions!! :)

 

Thursday, April 3, 2014

BANALITY OF EVIL IN THE AGE OF THE INTERENT




Updated 11/26/2015
Updated 11/28/2017


Like most people, you've peeked at a business' reviews online before investing money or precious  time on it, in the belief that the reviews are written in good faith. Most of us do it because we trust word of mouth opinions of our equals much more than direct marketing by the business itself. 

But the reviews you are about to read are from people who have never  been to our business, and as alarmingly, some who have shown up under false pretenses to harass us.  

Here  is why: 
We believe it is our right to know what we are eating and  that GMOs have not been shown safe for our patients to eat

We have been vocally advocating for labeling GMOs since Proposition 37 was placed on the ballot in California.   Having read thousands of long and complex peer reviewed studies on GMOs over the last six years, we have very serious medical concerns about genetically modified foods, also known as GMO, present in many pet foods. We are concerned that they are contributing to allergies, inflammatory bowel disease, pancreatitis, liver and kidney disease, as well as kidney stones among others. Recently, the World Health Organization Cancer Experts found sufficient evident that Round Up (Glyphosate), present in unmeasured and unknown quantities in most GMOs, is carcinogenic to animals and probably to people, particularly causing non Hodgkins lymphoma and leukemia (AML). Remember, the most common GMO trait is Round Up (Glyphosate) resistance. 

As a result, we are being targeted in a smear campaign, psy. ops (torrents of hate lit with gaslighting),  business sabotage, harassment, intimidation, bullying, defamation, libel and legal threats. A Monsanto mommy blogger-"farmer" married into a farmer family that, I was told in confidence, makes generous profits selling pesticides on the side --arranged complaints to be lodged with the veterinary medical board jeopardizing my veterinary license.

 I invite you to find out what's involved in admission to UC Davis Veterinary School, graduation, passing two separate Boards (federal and state) and then watching Monsanto's trolls threaten your medical  license -- mine is. Why?

Because I have been doing my best to inform the public. The world needs to know that the cancer specialists at the World Health Organization have just classified Round Up sprayed on 90% of GMOs  as a probable carcinogen.

The most prevalent GMOs are Round Up-ready and  no agency in the United States monitors Round Up residues of a ubiquitous chemical  in our food. We suggest if you haven't been paying attention to food ingredient labels: you begin to read them very carefully now.  Stay away from any package that contains soy, corn, sugar beets/ beet pulp, alfalfa -- very common ingredients in pet foods.

MonSatan: Stalking Critics like Predators Stalk Prey


This is Yvette






They take pictures of themselves in front of our hospital, as proof that they only visited when we were closed. Yeah, right...


We  have been seeing  suspicious clients sporadically since Proposition 37. Arriving with an agenda rather than seeking care for their pets, our unwelcome MonSatan  "clients" post vicious Yelp reviews and then link  them on Twitter and other GMO discussions. The video below illustrates a Monsanto affiliated front group, Biofortified, planting their mascot in our flower bed. They want to know they are physically present at our hospital. We know  many negative Yelp reviews are fake because the clients -- just like Stephan, Mike B, and several others, who I invite you to learn about in a linked 10 minute video -- don't show up in our records 

Monsanto's GMOLOL 10,000-troll FB page Cyber-Attack










This is a forgery of an image from our Beach Vet Hospital's Facebook page (as it was being assailed by Monsanto's GMOLOL 10,000-troll-strong Facebook group) joined to an image from Stephan's own Facebook page, on Yelp.




And this is Stephan admitting to cyber-attacks to drive down ratings.


(Because every credible science organization boasts about ruining the reputations of people with whom they disagree...)


Stephan equating labeling GMOs to the persecution of Jews in the Holocaust!




To someone whose grandpa was one of six millions Jews to perish, growing up in a home where two giant tomes of black-and-white photos of the Holocaust and Nuremberg trials graced our coffee table, trivialization of the horrors was beyond shocking.



Stephan equating a celebrated author- Nassim Nicholas Taleb- with Hitler. He is being targeted, just like us, for advocating Precaution with GMOs.


"...an explanation based on will rather than knowledge" -- Isn't that ironic?


"We Will Not Forgive and We Will Not Forget. Expect Us." -Monsanto





Stephan's GMO smear campaign of our business on Google, where you can find multiple fraudulent reviews of our business.





"Client" shows up for a service she insists she can do herself


This anomalous "client" came in for a complementary staple removal.  We have a policy of providing complementary suture or staple removal for our own clients, as well as clients of other hospitals --based on records and instructions of  the primary surgeon.

However, when asked for records and surgical instructions,  this "client" acted suspiciously evasive. She had no records from any hospital  nor would she provide the name of the surgeon, or the phone number of the hospital where the surgery was done.





"Was it done at our local emergency hospital, who we work with extensively?"
"No"

   In addition to demanding free staple removal, this "client"  reiterated  the point that  she could remove the staples by herself! If you click on her review you will notice that is exactly what she did, with professional grade staple removers, begging the following question:
  • "Why show up to our hospital at all for a service you insist  you can do yourself?"
  • Answer: She didn't need our services to begin with. This fake uninvited client simply showed up to write a fraudulent review.
Unlike routine surgeries, bite wound healing  is neither predictable nor routine because most of the trauma is beneath the skin. Bite wounds are not cutting wounds--they are crushing wounds. Which means that if we remove sutures or staples prematurely, against the primary surgeon's advice-- we have now made ourselves liable- opening ourselves up to a lawsuit.  


Client that Yvette "just happens to know" leaves this review


The majority of his reviews are of businesses in Arizona and Utah...







 Yvette with Monsanto's Public Relations personnel: Doc Cami Ryan and Vance Crowe 



 


Internet Gang Rape

 Yvette with Janice Person, Monsanto's PR person who started the GMOLOL 10,000-troll Facebook page that cyber-attacked our 500 person business page, managing to have us banned from our own business page, attacking and insulting us, and harassing our clients. 







Yvette with Monsanto's Cami Ryan and Kavin Senapathy, featured on Monsanto's blog










Monsanto's Internet Gang Molestation











Dr. Frank responds about Mike B., a "client" who left us a one-star Yelp review claiming that we neglected to vaccinate his dog, and that Dr. Frank treated his dog when it contracted the infectious disease, parvo, a disease neither of us has seen in an animal in seven years in Long Beach (described in the video above).



https://www.facebook.com/beachvethospital/photos/pb.287236524757921.-2207520000.1448657897./528928333922071/?type=3&theater




GMOs beg a Simple Question:

 Why Are  Pesticide Companies  in Charge of Your Food? 




If, after reading this story you feel compelled to give us a high five on Yelp or Google, we really do very much appreciate it. 

Saturday, February 1, 2014

Stumbling into the Twilight Zone.

Dazed and Confused 




If you found  my blog seeking veterinary advice and feel like you've just entered the Twilight Zone, my apologies.    I really did start it  to educate pet owners on veterinary medicine! 


Hopefully this entry will explain the reason for the confusion. 

My undergraduate degree is in biochemistry.  Prior to veterinary school I worked sequencing DNA. We used restriction enzymes to map DNA in the 80s, but  sequencing projects taking years in the past can be done in minutes with automation today.  Later I worked on a project  genetically engineering yeast for the brewing industry, which failed. But, this training and experience gives me an understanding of  the science of genetic engineering and awareness of  genetic modification of our food supply most private practice veterinary clinicians lack.  


Aside from proper vaccines, nutrition plays a key role in preventive medicine. Having noted improvement in multiple pets after elimination of genetically modified ingredients,  such as corn and soy from their diets, I began to research the safety science of GMOs. 

Sprinkled among pet care subjects (and music), you will find discussions of the safety aspects of genetic engineering of food.  The majority of the population is  unaware of GMOs, even as most pet foods and  more than 70% of the human food at the supermarket contain these genetically altered  ingredients.

Thus the  point is raising awareness about GMOs among the general public and the medical community.

 As the public becomes more aware, I hope people will  raise questions with their veterinarian, as well as their MD  and their pediatrician, who might likewise be in the dark.

I welcome your questions and comments, regardless of whether they are about  pet care, genetic modification,  music or "whatever". 

Warmest regards,

Dr. Ena


  

Thursday, January 16, 2014

If humans were rats...

Monsanto GMO safety test assures... half would be dead *
the rest would suffer from  kidney and liver disease in under 90 days...



Veterinary Medicine Perspectives 

I Can't Get No Satisfaction**

 



400 rats...

 test results published for as few as 4 ?!


First Red Flag:  Ns (number of rats) in all Tables in this study should add to  200/sex -400 TOTAL 



“Results of a 13 week safety assurance study with rats fed grain from glyphosate tolerant (Round-Up-Ready) corn." 



Hammond B, Dudek R, Lemen J, Nemeth M.
Food Chem Toxicol. 2004 Jun;42(6):1003-14



Dear Food and Chemical Toxicology: shouldn't you retract Hammond's study-- rather than Seralini's ? 

Food and Chemical Toxicology, the journal which recently retracted the  infamous  Seralini study- reporting  kidney & liver disease, as well as unexpected breast canceralso published four safety assurance studies by Hammond et al.  

Seralini  was crucified in the popular media: " Commentators variously claimed the study to be "biased", "poorly performed", "bogus", "fraudulent", "sub-standard", "sloppy agenda-based science", "inadequate" and "unsatisfactory". Séralini was said to have "sought harm" for the rats, the experiment was dismissed as "inhumane" and the research group was called "partisan". France was outed as "the most anti-science country in anti-science Europe" and vociferous GM supporters"  

The reason for the retraction was simply bizarre. The study that replicated Monsanto's 90 day safety test on Round Up Ready Corn (NK603) by Hammond et al  was retracted because the results were found  to be inconclusive : "Ultimately, the results presented (while not incorrect) are inconclusive, and therefore do not reach the threshold of publication for Food and Chemical Toxicology" 
If this standard was applied to other studies in any field of science, 90% of studies would have to be retracted. But of the two studies, Hammond's suffers from far worse, indeed- catastrophic flaws.  

Agricultural GM cheerleaders who lobbied aggressively for retraction of Seralini's life-long rat study, made darn sure that Hammond's study which triggered Seralini's study-never ever ever never drew any attention. 


Read and understand this study- representing a standard safety test on the most prevalent transgenic crop in the food supply. 



Full text of the study is linked above-  take this opportunity to read the study linked --few GMO studies are OPEN ACCESS. In fact the majority are neither peer reviewed nor published. 


Consider checking off the boxes as you go along


The study is a safety assessment to ensure that the RoundUp Ready corn (NK 603) is as safe as conventional corn involving two components. Firstly, it is an evaluation of safety of the newly introduced trait- Round Up Resistance conferred by the Round Up Ready transgene (CP4 EPSPS). Secondly, it is an assessment for possible toxicity due to unintended pleiotropic effects resulting from the insertion of the trait (transgene). [*] 

But it appears this study does not provide robust evidence to support either claim, is even less  conclusive than Seralini- and should likewise be retracted. 

The following dissection should clarify the reasons why  it fails to live up to its title- Safety Assurance Study- a very bold claim, unsupported by evidence. 


DATA is reported for HALF and sometimes fewer animals: Selection Bias


Elementary school arithmetic for non-scientists.  Number of experimental animals (N) in Tables should be 20 because there were 20 rats/sex/group.


If you add the experimental and control rats in any category, test  results should be available for  400 rats.  Let see what happens when you try this exercise for bilirubin, in the table posted above, as an example.  For male rats (Table 4)  bilirubin is reported for 4-6 experimental and 36 control rats, while for females (Table 5) it's reported for 7-8 experimental and 49 control rats.  
So results are reported for  (4 to 6 + 36) + (7 to 8 + 49) = 96 to 99 rats. 

          Where are the remaining 301 to 304 rats......on vacation ?   






And what does a result on 4 to 6 mean, anyways? Was it four, five, or six rats? 


Don't feel too bad if you aren't finding it easy, because the "esteemed"  scientists and editors at  Food and Chemical Toxicology, as well as regulators---   flunked elementary school arithmetic. 

The reason blinding has been used for hundreds of years in research is to prevent just this type of biasScientists often want a particular outcome from an experiment, and it is  possible to choose the animals to test in such a way as to achieve desired results.

 In a non-blinded experiment, where the researchers know which animals are exposed to which food, and test results are published for less than half the rats ( N 4-10, instead of 20 in Tables 2,3,4), the researchers are free to cherry pick the rats based on overt clinical signs.  

If the transgenic corn was engineered with a metabolite toxic to the kidneys, the most  affected rats would be identifiable, as they would be drinking excessively and urinating excessively. Rats with liver disease could likewise be avoided for sampling  because their white skin would glow yellow  due to jaundice. 

But beyond just that-- biochemistry and hematology are reported for half as many rats as were necropsied-dead-thus the data literally says, only half of the rats were analyzed because the other half died. Laboratory rats rarely to never go on  Caribbean vacations.


 Bias does not have to be due to deliberate deception- human nature makes scientists vulnerable to confirmation bias...which is the reason blinding is used in good experiments to mitigate bias. 

 Data and conclusions of a non-blinded experiment missing data for more than half the animals should be declared invalid by design.







  •  I could stop right here..this study is  "inconclusive" based on this fact alone.... 

 but I shall go on...because there is so much more.

Safety of introduced CP4 EPSPS trait

ALLERGENICITY  

of Round Up Ready (CP4 EPSPS)  transgene protein

 NOT Ruled Out 



Committees of global experts have created decision trees largely based on assessment of IgE-mediated food allergenicity for risk assessment.[8] The WHO guidelines state that a transgene with greater than 6 (continuous) amino acid homology to a known allergenic epitope or > 35% of (discontinuous) sequence , should be further screened on 25 individual serum samples with high IgE titers to that air borne or food borne allergen.
[2] CP4 EPSPS protein has homology of SEVEN amino acids  to a known and prevalent allergen- dust mite allergen (der p 7).[1] 
Hammond cites Harrison et al, a study on digestibility of CP4 EPSPS protein as evidence for lack of  allergenicity of the introduced transgene. While digestibility is a preliminary step in screening novel proteins, it is not a substitute for immunologic studies. Hammond also cites studies on Round Up Ready soybeans as evidence of lack of allergenicity. However, studies on  Round Up Ready soybeans are not a substitute for studies on Round Up Ready corn.  Moreover, a targeted analysis on serum from patients with dust mites allergies was not performed  on 25 serum samples in the studies.  The largest inhibition ELISA on CP4 EPSPS was reported for Round Up Ready soybeans on a trivial sample of 4 [9]  and thus the studies would not uncover cross reactivity  between Cp4 EPSPS and der p 7  in soybeans.  




Research to verify lack of cross-reactivity is not cited by Hammond et al, and a literature search failed to uncover such studies on 25 serum samples with high levels of IgE to dust mites.[9]   Inhibition ELISA studies can and should  be conducted to assess for the presence of allergenic cross-reactivity between the EPSPS CP4 protein in corn and der p 7 to definitively rule out allergenicity [10] This is a minimal standard of risk assessment for known allergens, while everyone accepts that even this standard leaves large gaps since not all allergies are IgE mediated.  



 This meticulously conducted  independent proteomics study on a different variety of genetically engineered corn [4] also shows a well known allergen.  This 2DE gel  detected 50KD gamma zein, a latent allergen expressed after the genome was disrupted by biolistics (gene gun).



Non-targeted “omics” profiling studies might be able to  detect unintended and unexpected changes  that targeted compositional analysis underpinning the current risk assessment by Hammond et al would not-- by revealing novel toxins or allergens; making GMO safety studies more conclusive   [11]   However omics are not part of the regulatory risk assessment and are not published for commercialized GMOs, but proper safety assessment must include profiling, because without them  safety studies are inconclusive.





  • Failure to rule out allergenicity  makes the study inconclusive ...but I shall go on.. .there is more




Toxicity due to pleiotropic effects resulting from insertion into the corn genome [*]


Random integration of a transgene may cause gene disruptions leading to sequence changes, production of new proteins or formation of new metabolites or altered levels of existing metabolites that could compromise safety. This includes the potential production of new allergens or toxins.[5] For example, a  proteomics study on maize demonstrated that 43 proteins were up- or down-regulated in transgenic seeds with respect to their controls specifically related to the insertion of a single gene into a maize genome by particle bombardment.[4]

Kidney and liver would most likely be some of the metabolic organs affected by novel metabolites or inflammatory proteins. And it turns out inflammation is reported in this study in both  liver and kidneys on histopathology of these rats. 


KIDNEY TOXICITY

 Sprague Dawley rats suffer from spontaneous kidney disease, chronic progressive nephropathy (CPN) which confounds toxicology studies.

Blood tests associated with kidney function (BUN, creatinine)  are not significantly elevated until advanced stages of disease, which makes the “normal”  tests reported in Tables 4 & 5 meaningless. 
A urinalysis does indicate progression and loss of renal function by declining urine specific gravity, elevated levels of urine protein/ albumin, and casts- prior to elevation of blood tests.

 These inexpensive and crucial functional tests are not published in this study nor any Hammond et al feeding trial.


  • Absence of basic renal function tests makes this study inconclusive. I could stop right here, but I shall go on...because there is more. 

The  findings reported in Table 7 are vague and not descriptive of the specific histopathological changes.  The earliest lesions of CPN in young rats are convolutions of a single proximal tubule showing basophilia and crowded nuclei, representing simple tubule hyperplasia, with thickened basement membrane (especially of  the Bowman's capsule),  which is not reported in this study. 
The study instead reports mononuclear cell infiltrate, which is  generally a feature of inflammatory/ immune mediated processes. However, CPN is not an inflammatory or vascular disease, and it has no immunological or autoimmune basis. [6]

 Regeneration is reported in 17/20 rats, which is disproportionately high to the number of animals in whom degeneration is reported, while these processes occur simultaneously. Thus without a  review of histopathology slides by independent pathologists assurances of absence of reno-toxicity can not be made.  

Furthermore, pathologists recommend histopathological grading on a scale of 0-4 (kidneys graded by the study pathologist as minimal = 1 (less than 25% of renal tubules affected); mild = 2 (T 25–50%); moderate =3 (T 50–75%); or marked = 4 (T 75%); [7] [6] which likewise was not done in this study, making a valid comparison of severity between the groups impossible.



In any case, sample sizes of 9-10 for whom results are published are too low to parse toxic  effects  from confounding  spontaneous kidney disease - unless the potential  toxin has a very strong effect  in a very short period of time. 

So, if you recall the main, and I believe,  valid  criticism of Seralini as having sample sizes too small  to draw conclusions, the same is the case with this study. The sample size is too small to rule out kidney toxicity, separate and apart from the  other flaws I list.  GMO toxicity would be masked by spontaneous kidney disease which doesn't  manifest until more than 75% of renal function has been destroyed.  


  • Failure to rule out reno-toxicity makes this study inconclusive. I could stop right here, but I shall go on... because there is more. 
http://www.largeverdicts.com/illustration/kidney-nephron.jpg

Liver toxicity 

Tables 2,3,4  report normal liver enzymes which would suggest that the corn is not hepatotoxic. Unfortunately they do not. 

Liver enzyme tests are not liver function tests-they are tests of inflammation.  In fact, liver enzymes can appear relatively normal in the face of liver failure.  Bilirubin is a marker of jaundice most often associated with hepato-biliary disease.   In cats the most common form of liver disease is known as hepatic lipidosis or  fatty liver disease. The same disease is recognized  in rats and in  people, and it is called  non-alcoholic fatty liver disease (NAFLD).
 Its prevalence rate  is rising- especially among kids.


 I present an illustrative  case report   with  blood work and a urinalysis in a cat with imminent liver failure, in whom liver enzymes were nearly normal.  The test most crucial for diagnosis was serum and urine bilirubin. 

Recall at the very beginning of this post there is a table that shows that Total bilirubin (t.bili) in Table 4 is reported for 4-6 out of 20 male rats (and 7-8 out of 20 female rats.) Bilirubin values in the urine are not published for the rats at all. 


The study reports multifocal chronic inflammation in most of the rats in Table 7 which is histopathological indicator of  chronic inflammatory hepatitis. Histopathological inflammation is usually associated with elevation of liver enzymes, interestingly reported to be within normal ranges, which doesn't make sense.  The clinical test veterinarians usually perform to assess animal liver function ( in contrast to inflammation) is the bile acid test  - available for rodents, but wasn't performed.


The liver represents a suitable model for monitoring  effects of a diet, due to its key role in controlling the whole metabolism.

 A study examining effects of Round Up Ready soy diet were studied on liver of  female mice in order to elucidate possible interference with ageing.  Several proteins belonging to hepatocyte metabolism, stress response, calcium signalling and mitochondria were differentially expressed in GM-fed mice, indicating a more marked expression of senescence markers in comparison to controls. Moreover, hepatocytes of GM-fed mice showed mitochondrial and nuclear modifications indicative of reduced metabolic rate. The study demonstrated that GM soybean intake can influence some liver features during ageing while liver enzymes (the tests reported by Hammond et al) were not afffected at all.  The mechanisms remain unknown, underlining the importance of  investigating  long-term consequences of GM-diets and the potential synergistic effects with ageing, xenobiotics and/or stress conditions. [12] [13]



  • Failure to rule out liver toxicity make this study inconclusive...

I could stop here... but there is more. 





Statistics

Type II Error


Tables 2-4 do not report precise number of rats. Means and standard deviations cannot be calculated for ranges (for example 4-6 or 9-10) of rats. 

A balanced experimental design would consist of 200 experimental and 200 control rats. Instead there are only 80 experimental rats raising risk of type II Error-- Not Finding Deleterious Organ Effects associated with chronic diseases that this experimental crop caused-liver such as NAFLD, bowel such as inflammatory bowel diseases and dysbiosis,  kidney toxicity and kidney stones or allergies for which this rat strain makes an inappropriate model. Due to brevity, 90 day trial design and long lag time between exposure and development, also-- cancer-- whether breast tumors or blood, kidney or other organ.  



Statistics make the study inconclusive.

Invalid reference groups.

The experiment was conducted on 400 rats fed two doses of corn (11% & 33%). A balanced experimental design using 400 rats would consist of 50 rats/sex/dose on transgenic corn compared to 50 rats/sex/dose of its isogenic parent line grown side by side-  agronomic factors (soil, fertilizers), and environmental influences (location, weather, stress) are all factors that must be considered during “GE versus non-GE” evaluations. [3]  Environment has been shown to play a prominant effect in the protein, gene expression and metabolite levels in plants- in one maize study 5 proteins, 65 genes and 15 metabolites were found to be differentially expressed.[5]  Approximately 100 total proteins were differentially expressed as a consequence of  environmental influence in a different independently conducted proteomics study. [4]   

Yet,  Hammond's reference/control groups A-F are grown in random geographic locales such as Indiana, Iowa and Colorado, while the genetically engineered corn was grown in Ohio! Thus reference/ control  A-F in Table 1  not grown in Ohio--are inappropriate reference groups used to establish invalid reference ranges. Shrinking 



  • I could stop right here. If the reference ranges for non-GE corn are invalid, it isn't possible to compare GE and non-GE for statistical differences within 2 standard deviations as the study does, which makes this study inconclusive   But I shall go on...because there is more. 

Baseline lab-work should have been obtained at the beginning of the experiment,  repeated mid-point and at the end of the experiment, in order to measure trends. A single lab test recorded at one time point is highly unlikely to parse differential effects on physiology of experimental and control rats, when no effort is made to measure and record  trends. Absence of metabolic trends makes this study inconclusive





I hope I've clarified  why this study by Hammond et al does not meet its stated goal of reassuring me of safety of this crop to rats. The other three studies linked above relied on  the same flawed experimental design.  By definition, no study on rats can meaningfully show safety to a human, since many adverse effects of food additives and drugs are often discovered only when large randomized epidemiological studies are performed on humans. 




In spite of  lack of  " conclusiveness"  factor  I outlined above, this study has not been retracted,  which suggests that the agricultural biotechnology science establishment is promoting GROSS and inexcusable scientific double standards. This is scandalous for many distinct reasons, not the least of which is that science is uncovering multiple mechanisms  which could have caused the rats in Serallini's study to develop breast cancer

So, the next time you read a GMO booster criticize Seralini, please direct them here to justify every one of Hammond's egregious flaws, as well as the fact that these safety studies haven't  been replicated long term--for a lifetime of a rat, which is the duration of time animals and people are expected to eat them. 










My hope is that unwrapping one study for readers will open your eyes to the fraud that is GMO safety testing. 

This, as well as the other 3 short term studies by Hammond et al, linked above, were cited by this  "long-term" review by Snell et al   which  claims to show long term GMO safety....an absurd claim!!!




"Some of my concerns with GMOs are “just” practical ones. I have read numerous GMO risk assessment applications. These are the documents that governments rely on to ‘prove’ their safety. Though these documents are quite long and quite complex, their length is misleading in that they primarily ask (and answer) trivial questions. Furthermore, the experiments described within them are often very inadequate and sloppily executed. Scientific controls are often missing, procedures and reagents are badly described, and the results are often ambiguous or uninterpretable. I do not believe that this ambiguity and apparent incompetence is accidental. It is common, for example, for multinational corporations, whose labs have the latest equipment, to use outdated methodologies. When the results show what the applicants want, nothing is said. But when the results are inconvenient and raise red flags, they blame the limitations of the antiquated method. This bulletproof logic, in which applicants claim safety no matter what the data shows, or how badly the experiment was performed, is routine in formal GMO risk assessment.
To any honest observer, reading these applications is bound to raise profound and disturbing questions: about the trustworthiness of the applicants and equally of the regulators. They are impossible to reconcile with a functional regulatory system capable of protecting the public." Dr. Latham

I could go on and say more ....but  I won't.   Hopefully, I've given  you enough food for thought. 


References

  1.BMC Structural Biology Screening of transgenic proteins expressed in transgenic food crops for the presence of short amino acid sequences identical to potential, IgE – binding linear epitopes of allergens Gijs A Kleter  and Ad ACM Peijnenburg

   2.Evaluation of  Allergenicity of Genetically Modified Foods Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology  January 2001 Food and Agriculture Organization of the United Nations (FAO) Rome, Italy  http://www.who.int/foodsafety/publications/biotech/en/ec_jan2001.pdf

8/29/2014 Edit: Snap! The WHO  link went dead. Try  : http://www.fao.org/docrep/007/y0820e/y0820e00.HTM


       3. ISB NEWS REPORT • MAY 2010 Molecular Profiling Techniques as Tools to Detect Potential Unintended Effects in Genetically Engineered Maize. Eugenia Barros. http://researchspace.csir.co.za/dspace/bitstream/10204/4465/1/Barros1_2010.pdf




   4.  J Proteome Res. 2008 May;7(5):1850-61.doi:10.1021/pr0705082. Epub 2008 Apr  Proteomics as a complementary tool for identifying unintended side effects occurring in transgenic maize seeds as a result of genetic modifications. Zolla L, Rinalducci S, Antonioli P, Righetti PG.

5. Comparison of two GM maize varieties with a near isogenic non-GM variety using transcriptomics, proteomics and metabolomics.  Eugenia Barros,Sabine Lezar, Mikko J. Anttonen,, Jeroen P. van Dijk, Richard M. Röhlig, Esther J. Kok3, and Karl-Heinz Engel

6.Toxicologic Pathology, 32:171–180, 2004A Contemporary Overview of Chronic Progressive Nephropathy in the Laboratory Rat, and Its Significance for Human Risk Assessment

GORDON C. HARD1 AND KANWAR NASIR KHAN 

7. Toxicol. Sci. (2012) 128 (2): 346-356. Chemically Exacerbated Chronic Progressive Nephropathy Not Associated with Renal Tubular Tumor Induction in Rats: An Evaluation Based on 60 Carcinogenicity Studies by the National Toxicology Pgram Ronald L. MelnickKathleen M BurnsJerrold M. Ward and James Huff  


8. Environ Health Perspect. 2003 Jun;111(8):1114-21.
Clinical and laboratory investigation of allergy to genetically modified foods.
http://www.ncbi.nlm.nih.gov/pubmed/12826483


9.http://www.allergome.org/script/dettaglio.php?id_molecule=2952&year=1

Yonsei Med J. Aug 31, 2006; 47(4): 505–512. doi:  10.3349/ymj.2006.47.4.505 
Evaluating the Allergic Risk of Genetically Modified Soybean

10. Clinical and Molecular Allergy 2007; 5:2 Assessment of allergen cross-reactivity Rob C Aalberse
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1797810/


11.Molecular profiling — a tool for addressing emerging gaps in the comparative risk assessment of GMOs Jack A. HeinemannBrigitta Kurenbach,, David Quist  
http://www.sciencedirect.com/science/article/pii/S0160412011001322


12.   2008 Nov;130(5):967-77. Epub 2008 Jul 22.
A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing.

13.  2002 Aug;27(4):173-80.Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean.

Source http://www.ncbi.nlm.nih.gov/pubmed/12441651

Footnotes:
[*] The study as designed by Hammond et al  does not permit evaluation for  pleotropic effects since there is a confounding factor that has not been segregated out. The corn was treated with Round Up- a mixture of glyphosate, AMPA and proprietary adjuvants. The authors  state that glyphosate wasn't detected at 250 ppb, however, the methodology isn't listed. Typically residues are measured by High Pressure Liquid Chromatography in tandem with Mass Spectrometry or ELISA. Since methods weren't published reported glyphosate residues are questionable. If indeed the levels of glyphosate were <250ppb they might not represent field conditions, and if greater-these additional chemicals make it  impossible to tease away any potential  metabolic toxicity caused by transgene insertion on the genome  from chemical toxicity of Round Up and its adjuvants. It is also the reason that Seralini in his retracted paper came up with the  "complicated design"  separating rats into groups exposed to transgenic corn alone ( to evaluate effects of transgene insertion on the genome in isolation of Round Up)  and those exposed to Round Up in the drinking water. 

*When I say NK603 killed half the rats-- it is literally what  DATA indicates.  Post mortem (necropsy or  autopsy)  histopathology in this study was done on rats who were dead, while biochemistry and hematology was reported for half of the animals necropsied.

**Scandalous! GMO safety studies are not designed, interpreted or reviewed by doctors in veterinary medicine-the only animal health professional with expertise  to interpret veterinary tests- even while the majority of GMO safety studies are performed on animals using  clinical veterinary tests.