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Feeling Overwhelmed? Start with Baby Steps

October 30, 2010 •  one comment.

 •  Blog, News

At the AllergyKids Foundation, we know it’s not uncommon to feel overwhelmed with the wealth of information available to you on television, the internet and in magazines. So we always emphasize how important it is to remember to take baby steps when it comes to making changes in the way that you feed your family.

Just as you didn’t wean your child from a sippy cup overnight or potty train them in a day, the transition to a new way of eating is going to take time, too.

So we’ve turned to one of our nutrionists, Joy McCarthy, who wants to help encourage you to start simple with these five tips for eating REAL FOOD:

  1. Read your food packaging labels. Avoid buying food with more than 3-4 ingredients. The simpler the better and more nutrient-dense.
  2. Buy food that doesn’t have a health claim. Real food doesn’t need a health claim. Focus on fresh fruits and vegetables. Have you ever seen a sign on a bushel of apples that read: Buy me, I will reduce your child’s asthma, help detox your liver or improve your colon health? Simply stated, real food doesn’t need a health claim.
  3. Avoid foods with ingredients you can’t pronounce or don’t recognize. This is the safest way to avoid chemical additives and preservatives that may cause an allergic reaction.
  4. Buy foods that are brightly coloured by nature means because it indicates a high level of antioxidants (apples, kale, carrots, spinach) as opposed to foods that are brightly coloured from a high level of chemicals (ie. Processed foods: artificially colored cereals, fruit juices).
  5. Ask yourself how long did it take to get from the earth to your dinner plate. The less processed foods you eat, the more nutrients you get into your body and the less likely it will contain additives that could cause health problems.

Joy McCarthy, is both a Certified and Registered Nutritionist (CNP, RNCP)* & Health Coach. The owner and founder of a Joyous Health – a wellness consulting company in downtown Toronto, devoted to inspiring and motivating people to make positive changes resulting in a healthier and happier lifestyle.

Joyous Health looks at the whole person and all the factors that affect your health. Please visit the CLIENT LOVE page to see how it impacts lives.

Worried About the Pinkwashing of Breast Cancer? We Are, Too.

October 26, 2010 •  2 comments.

 •  Blog

Submitted by Danika Carter to the AllergyKids Foundation October 26, 2010

I’m sure you know October is Breast Cancer Awareness Month. How could you not know? Everything not Halloween related has a pink ribbon on it.

But do we really need any more awareness? Isn’t everyone “aware” of breast cancer now? With 1 in 8 women getting breast cancer in her life, and about 40% of people getting some form of cancer in their life, aren’t we all aware? Don’t most of us know someone who has had breast cancer, or who has had a family member with breast cancer? Personally, I’ve known more people who’ve either had breast cancer or had a family member with it than I have fingers.

So what is this pink ribbon campaign all about and is it effective? You might be surprised to know that the pink ribbon campaign was started by large corporations, not by grassroots efforts. It has been a marketing ploy from the very beginning.

Breast Cancer Awareness Month was created by the corporation AstraZeneca in 1985 and they continue to be a major sponsor. Until recently AstraZeneca made toxic chemicals, many of which have been linked to cancer. They currently make the top cancer treatment drug, and they own cancer treatment centers. They make money giving us cancer and treating us for it. Is it any wonder there’s little to no focus on prevention and we’ve yet to see a cure?

According to Stacy Malkan, author of Not Just a Pretty Face: The Ugly Side of the Beauty Industry, the original ribbon wasn’t pink at all, it was peach. The peach ribbon was introduced in the early ‘90s by Charlotte Haley. She was angry that only 5% of the National Cancer Institute’s budget when towards cancer prevention and lobbied for the issue to receive more attention.

Shortly after Charlotte began her lobbying efforts with her peach ribbon she was approached by Evelyn Lauder of Estee Lauder and Alexandra Penney of Self Magazine who wanted to outdo the previous year’s breast cancer awareness month edition, and asked Charlotte if they could use her peach ribbon. The Estee Lauder Company wanted to distribute them at their cosmetics counters. Charlotte refused. “For Charlotte the ribbon was a tool to inspire women to become politically active, not sell products” says Stacy Malkan.

So, Estee Lauder changed the color to pink because focus groups said it was calmer, safer, and happier. Since then it has been used as a marketing ploy to pray on people’s emotions and get them to purchase products, many of which contain chemicals linked to cancer. It’s insincere. In fact, to me it’s emotional manipulation. With so many of us loving someone who’s either had this disease, or known someone who does, these companies play on our pain, and our fear of getting the disease. Buying pink ribbon products gives us the feeling we are doing something positive; when in reality it has very little effect. Most companies don’t even tell us how much of the money from our purchase is going towards charity. Many companies put a ceiling on how much they will donate, no matter how much they sell.

We’ve had 25 years of awareness campaigns and more women than ever are getting breast cancer. Millions of dollars are donated every year to organizations looking for a cure by the very corporations that are polluting our bodies and our environment and fighting against stronger toxic chemical laws. And, it seems every year we see more and more pink ribbon products and are told to “shop for a cure.”

We don’t need any more awareness. What we need now is action so that no one else needs a cure. We need to lobby our elected officials at all levels to protect us from carcinogens and hormone disruptors. And, it’s election season, so we need to do it NOW. As soon as you are done reading this, call the candidates running for office in your area and tell them that if they want your vote, they need to come out strongly in favor of toxic chemical reform.

We also need to start detoxing our lives. Most cancer isn’t genetic. It’s caused by environmental factors. We need to change every area we have control over. By doing so, not only are we protecting ourselves, our families and our environment, but we are also sending a strong message to the corporations exploiting this disease.

We CAN make a difference…on ourselves, our families, our environment, large corporations and our government. We are women and we are strong. As Stacy Malkan says, “Women are 54% of the vote, 60% of college graduates and buy 85% of consumer products.” There is no reason we can’t be effective.

So go out and do something real to prevent breast cancer. Do it now. Think before you buy pink ribbon products. Support organizations that are fighting for cancer prevention:

For more information on the history of pinkwashing read Chapter 6 of Not Just a Pretty Face and listen to this interview with Breast Cancer Action staff

This article originally appeared @Your Organic Life’s Blog as seen here.

Breast Cancer: 4 Foods to Avoid

October 21, 2010 •  one comment.

 •  Blog, News

It’s October, which means it’s Breast Cancer Awareness Month. According to the American Cancer Society and recently seen on CNN, one out of every three women is expected to have some form of cancer in her lifetime. That stinks. On top of that, one out of every eight women gets breast cancer.

But the good news? Only one out of every ten breast cancers are genetic, which means that nine out of ten breast cancers are environmentally triggered.

So instead of calling it Breast Cancer Awareness Month, let’s start calling it “Breast Cancer PREVENTION Month”.

I mean, why wait? If you could take action today that just might prevent breast cancer down the road, you’d do it, wouldn’t you? Well, thankfully, Dr. Andrew Weill posted a few dietary tips this morning that any mom can take anywhere to help reduce her chances of developing breast cancer.

Here are some dietary habits to avoid, as they may increase the risk of breast cancer, according to Dr. Andrew Weil. And while you may not want to jump in on all four, perhaps consider adopting one of the changes from the list below as a preventative measure in our fight against breast cancer:

  1. Eating too much fat. Keep your dietary fat content low – below 25 percent of your daily calories is ideal.
  2. Consuming animal fats, polyunsaturated fats (including many vegetable oils), and hydrogenated oils (margarines and vegetable shortenings) can all increase cancer risks. Minimize consumption of all.
  3. Drinking alcohol. Even in modest amounts, alcohol consumption is associated with an increased risk of breast cancer.
  4. A daily intake of conventionally raised meat, poultry, eggs, and dairy products. These may contain hormone residues that influence estrogen metabolism. Replace with organic, hormone-free versions and use sparingly.

Remember, there is so much that we can do to protect the health of our families. And while we can’t do everything, we can all do something. And that is a great place to start!

To learn more about the environmental triggers for breast cancer, please visit www.pureprevention.com

The Power of Going Gluten-Free

October 8, 2010 •  5 comments.

 •  Blog, News

Submitted by Elaine Taylor-Klaus

My firstborn daughter was a perfect, quiet baby for fourteen days.

On day 15, she started to cry – often uncontrollably. It lasted for months. The pediatrician called it reflux, and sent us out the door with Mylanta. Eventually, a specialist put her on a medication – one that is no longer FDA approved – and the screaming stopped. Temporarily.

Medical mania began for my daughter.

For a little while, she was a happy baby. Nursing, eating, sleeping, playing…doing her job as laid out for her in the baby handbook. Many of her milestones were typical – she crawled and walked on cue. Some were even exceptional – she was talking in full sentences at 18 months.

But when she turned 2, the “Linus-routine” (thumb-sucking with a blanket over the shoulder) grew excessive, exacerbated by clingy behavior and a tendency to lie around at pre-school when others were actively engaged. This time the diagnosis was allergies. Antihistamines entered the picture (and this was no cameo performance).

While the allergy meds helped with the episodic lethargy, and the chronically stuffy nose, it did not change a general sense that this child was clingier than others, hesitant, shy in a way that I can only describe as atypical. As only a parent can really understand, there was always something “off.” Overly sensitive, temperamental, she was unable to regulate her moods and had extremely poor follow-through – despite a strong family environment, actively engaged grandparents, and a wonderfully playful father.

At the age of 3, her pre-school teacher raised concerns about manual dexterity—not using scissors as well as she might. Age 4, she made her first of many switches to a new school that might be better suited to her disposition. She shied away from positive feedback, resisted celebrating her successes, and had virtually no threshold for frustration. Her meltdowns were legendary.

Age 5, we start meeting with educational consultants, trying to decide whether to give her an extra year to mature. That’s the year she started punishing herself so severely we never had a chance: “I don’t deserve to be in this family,” she would cry at the slightest mistake. When she began to respond at age 5, “I don’t deserve to live,” I reached a breaking point. Enter psycho-educational testing.

The testing results brought information and more befuddlement. Age 6 she changed schools yet again, and began “Vision Therapy.” Homework started. The school struggle began. This brilliant child who had the vocabulary of a typical 5th grader by age 5, could take two hours of screaming and fighting to get 5 minutes of homework completed. Simple ADHD, even with Anxiety, could not account for the intensity of the drama at home.

At this point, the teacher’s approach was critical. Second grade, the teacher ‘got her,’ and all was well. On the one hand, she thought everyone was her friend. Unfortunately, this is when the playground bullying began. A defeated helplessness set in, low-self-esteem locked itself into her psyche. Enter social skills programs.

Third grade, it was too much. Both social and academic realms were severely impacted. She broke her wrist – twice. Someone suggested a nutritionist, but things were going down hill too fast. To be honest, I was skeptical -­ we had had no success with the “Feingold Diet,” and the effort had been a nightmare. Plus, the pediatric orthopedic specialist (lest DFACS come to check on two broken wrists), said her bones were fine.

More educational testing. It was time to try medication. We tried. And tried. And tried. It felt like our precious child was a pharmacological experiment. There were unraveled socks, and facial tics. There were questions raised about bipolar and Asperger’s syndrome. I began to wonder if she would ever become an independent adult.

Nothing made a difference for more than a few days. Enter Occupational Therapy.

So after months of trials, and more assessments, and no improvement in sight, the psychologist presented to me a long list of ‘diagnoses.’ With tears in my eyes I asked, “Where do I start?”

She said, “You start with the metabolic.”

Off we are sent to Kelly Dorfman, a nutritionist who specializes in working (thankfully, over the phone) with kids with learning disabilities and special needs. She had a reputation for working with complex children. I had actually had an appointment with her about 1 ½ years prior, but had canceled it when we started the medication approach.

With all the years of doctors and therapists, this was, by far, the best $150 we ever spent!

I made an appointment, wrote my daughter’s history, sent it to Kelly. Ten minutes into our telephone appointment she said, “Sounds like gluten.”

“What’s gluten?” I asked. She told me. I cried.

My daughter was about to turn 10 and this nutritionist was suggesting I remove all the food from her diet which (we thought) brought her comfort: pasta, bread, pizza, etc. I looked up gluten-free food. In those days, about the only guarantee of a ‘processed’ food she could eat (that didn’t taste like cardboard) was Frito’s. I cried some more.

Kelly explained that gluten sensitivity is not uncommon in Jews of Eastern European descent. She explained the difference between Celiac and gluten intolerance and talked to me about the “gold standard” of testing – a biopsy (which is still not 100% accurate). There was a blood screen, but it was inconclusive. She suggested I just try to take her off of gluten for a few weeks to see what happened.

Meanwhile, our daughter had an episode at camp that suggested she might have irritable bowel syndrome. It was the first gastro-intestinal “symptom” she had exhibited since the reflux of her infancy. Back to her pediatric gastroenterologist. I told him Kelly suggested we take her off of gluten. He waved it off, saying, “We’re not going to try that.”

But we did. And it was incredible.

About this time we had been having our daughter’s psycho-educational testing re-done – again – this time by a neuro-psychologist. I had started filling out the parents’ forms over the summer, but never finished them. I went to complete them just before the appointment, when our daughter had been off of gluten for about 2 weeks. My answers were different. I called the doctor to ask what to do. He told me to finish the forms, and he would score them separately.

So I did. And he did. And wow! what a difference.

In two weeks, she had gone from “off the charts” emotionally to “within the range of normal.” It was unbelievable. It felt like a miracle.

Within four weeks, we were negotiating with the psychiatrist, and within six weeks she was off all medications (except those for allergies.)

We initiated an intense nutritional supplement routine, much of which we continue to this day. We ‘chelated’ with vitamin C, restored the natural flora of her gut with probiotics, and lubricated her brain with fish oil. She got bi-weekly methylated B-12 injections, which helped enormously with mood. We even used massive doses of fish oil to treat her anxiety.

Our daughter was a new person.

In the process, my husband had also stopped eating gluten, and everything started shifting for him, as well. For him, it was as if a fog – one he had lived under all his life – just lifted. He had a new lease on life.

I wanted to shout it from the rooftops, scream it to anyone who would listen – she feels better. She is better. Even now, six years later, I cannot retell this tale without tears in my eyes.

We returned to the pediatric gastro who didn’t exactly embrace our ‘anecdotal’ evidence. He suggested we put her back on gluten for five weeks so we could do a biopsy to confirm Celiac Disease. All I could think was, “are you kidding?” We respectfully declined.

Five weeks after going gluten free, she had already experienced what we have coined “The Matzah Ball Incident.” It was the Jewish New Year, and she was feeling so deprived. How much harm could it be, I reasoned, to let the poor kid have a couple of matzah balls in her chicken soup?

She was sick – I mean sick – for six days. Diarrhea, stomach cramps adding to emotional distress, mood imbalance –basically, she could barely cope with life. At the end of that time, she sat next to me on our red sofa, and sobbed, “I hate to admit it, but I feel better when I don’t eat it.”

And that was it. Ten years old. The strongest willpower of any person I’ve ever known. She may not be able to keep a neat desk, or plan a birthday party for a friend, but this kid can advocate for herself like nobody’s business. She has discovered gluten in things even we, her hyper-vigilant parents, had not thought to ask (like hamburgers).

There is more to the story, of course. I wish I could tell you that discovering the gluten issue was a ‘happy ending’ to our family tale. The truth is, it was more like a Happy Middle.

Removing gluten was not a panacea for all of her challenges. By reducing her “toxic load,” it enabled us to begin to address some of her other health challenges with less interference. It was like removing a gigantic irritant, a piece of sand under a contact lens.

Some of the changes were downright shocking. After years of rapidly deteriorating eyesight, my daughter’s glasses’ prescription suddenly stopped changing. Similarly, 30 years of severe gum disease virtually healed itself over a six month period for my husband –the periodontist he had been seeing since he was a teenage was amazed.

The impact of starting life over at 10 – and 40 for her father – was miraculous, and incredibly challenging. Relationships had to be re-negotiated, patterns of behavior were re-established, depression over years lost was cautiously managed.

The last six years have featured a whole new host of medical professionals – some ‘natural,’ others with MDs, and all, whenever possible, with a more progressive approach to treatment.

Initially, we needed someone to actually prescribe the B-12 injections: enter Developmental Pediatrician & natural MDs. We’ve needed immunotherapy and sinus surgery: enter Allergists & ENTs.

A big part of my job has been navigating the slippery relationship between the traditional and the alternative, trying to make the best decisions possible, with often very little ‘solid’ information.

As parents, we’re called upon to make complicated medical decisions without any training or expertise. It’s maddening. It’s frightening. And we shouldn’t have to do it alone. To be honest, I have searched for someone local, with a medical degree, to monitor and help me understand what is going on with my daughter – but to no avail.

Once we discovered the power of gluten, I became a health advocate and parent educator, establishing a speaker series to provide parents with excellent, current information on a wide range of issues relevant to special needs kids. When things felt stable enough at home, I went back to school and became a personal coach.

I believe passionately that parents of special needs kids deserve a lot of support. As a coach, I guide parents to identify their values, use them as a lens for decision-making, and trust their instincts. Those are the only things in this parenting-game about which they can become certain.

The truth is, despite dozens of specialists over the years, the only people who truly understand the big picture of my complicated daughter is – we, her parents.

Our kid’s got some kind of an auto-immune situation, and whether its Celiac, or not, she is chemically sensitive, and that’s the challenge she’ll have to deal with the rest of her life. There isn’t a doctor out there who really gets her completely – though her psychiatrist and psychologist have been unbelievably supportive throughout the journey. I figure it will make her an unusually empathetic adult.

So the appointments continue, and we try hard to fit them in amidst the school and sports of her busy teen-age life. But here’s the thing that I never lose sight of: She has a busy teen-age life. Before gluten, it never looked like that was a possibility.

As a parent, when you hear multiple diagnoses, and you have a library of books about every psychiatric condition and learning disability – as well as spirited and sensitive children – you wonder whether your child will ever become an independent adult.

Now, I take no milestones for granted. I appreciate every transition, and embrace every new development with gratitude.

What I Know ™:

1. Attentive parents know their kids better than anyone. Yes, even better than doctors.
2. Parents need to trust their instincts: be willing to say no to the medical experts and the naysayers. Do not give up!
3. Everyone has a limit to the toxic load they can bear, and these days people are hitting that limit much more quickly than in the past.
4. Stress and anxiety will exacerbate any condition, and should not be underestimated. Sometimes, getting Anxiety under control enables other improvements to take hold.
5. Anecdotal evidence is NOT irrelevant.
6. Before you start putting chemicals into the body, pay attention to what is already going in (like, food!)
7. Treating symptoms is not as effective as getting to the source of a problem. As we grow, the symptoms to an underlying problem [may] change, but that does not mean the problem has gone away.
8. Kids are the most resilient beings on the planet, and they can be highly motivated when they are included in their health care decisions.
9. Family support can make all the difference – but you have to be willing to talk about what is going on without shame or embarrassment.

10. No one should have to go it alone – there are now many resources and people to help. If possible, try to find one person – a coach, or friend – who will not give you advice, but will help you figure out what YOU think is best.

If you do believe that there is something going on with your child which is not readily explained by traditional medical examinations, here are some tips and guidelines for exploring whether foods (gluten or otherwise) or nutrition might be an underlying concern.

The information below is What I Know ™, gleaned from years as a parent advocate and coach. The following is not medical advice:

• Check in with your doctor and let her know that you’d like to look at whether unidentified food sensitivities might be aggravating your system (note: avoid using the word allergy)

• Ask to be tested for Celiac Disease BEFORE you remove gluten from the diet

• Ask your doctor if they are able to order an IGG blood allergy test. This does not measure the histamine reaction that traditional allergists are looking for, but how the blood reacts to a substance over time. Allergists still tend to discredit this test, though ENTs are using it more frequently.

• Remember that you have to be an advocate in this matter. Many physicians will make you feel like you are crazy, and you are not. YOU are looking at the big picture, while most medical folks tend to come from a more narrow perspective.

• Do some reading about your symptoms to determine what major food allergen you think might be the culprit.

• A great resource, besides the internet, is Doris Rapp, M.D.’s

“Is This Your Child? Discovering and Treating Unrecognized Allergies in Children and Adults.” It is a thorough reference guide, Best Seller, 1991.

• If you plan to remove a food from your diet, try to do it for a solid 4-5 weeks. Two weeks may not be long enough.

• Keep a food journal!

• The top 8 food allergens are: milk, wheat, soy, egg, tree nut, peanut, fish and shellfish. As of this year these are required by law to be listed on food labels in the U.S.

• Gluten is not listed directly on many labels because it is not a specific food. Gluten is the protein in wheat, barley, rye (and some think Oats). It is actually hidden in MANY foods. Soy sauce, for example, is generally made from wheat. Watch out for words like “food starch” and “flavorings,” because that tells you nothing about what is in the food. Read about gluten if you plan to try to eliminate it – there are fabulous resources on line these days.

• Removing foods from your diet is much easier these days than you might think.

• Google “Gluten Free Restaurants” in your City (or Dairy Free, Peanut Free, etc), and you’ll find restaurants that cater to your needs.

• A few Gluten Free specific tips: Tortilla chips are almost always GF, and Amy’s GF Pizza and Mac ‘n Cheese are good and easy. At your local Health Food store you can usually get crackers, pretzels, frozen breads, etc. The mainstream groceries now carry a lot, too, but be cautious because the staff is not generally knowledgeable and will often put glutenous foods on the GF shelf. Chex Cereal is now GF, and Betty Crocker now has a GF line, as well.

• I could go on for days with all of our favorites, but I’ll just mention two brands of mixes that I find great. You can’t go wrong with ANYTHING by Breads from Anna or 1-2-3 Gluten Free (the best brownies EVER).
• For anyone in the Atlanta area, Return to Eden – a healthy grocery – has the best GF program I’ve ever seen, with a dedicated staff member for GF issues. Atlantis in Dunwoody does a good job, too.

This article first appeared on ShareWIK.com, where the author, Elaine Taylor-Klaus, is a regular columnist. Other writings by and information about Elaine can be found at http://tinyurl.com/ElaineOnShareWIK and at http://www.touchstonecoaching.com/manage-health/

The AquaBounty Salmon: Will the World’s First Commercial GE Animal Be an Albatross?

October 7, 2010 •  2 comments.

 •  Blog, News

Submitted by Jonathan Latham and Allison Wilson of The BioScience Resource Project

Is it unrealistic to expect the scientific approval process for the world’s first commercial genetically engineered (GE) animal, the AquAdvantage salmon, to be rigorous and complete? Or for the applicant to present experiments that fully meet regulatory expectations? If you expect these things, it seems, you expect too much. Despite the biotech industry’s “dedication to rigorous science-based risk assessment”, the science of the AquAdvantage salmon is full of holes. Its maker, AquaBounty Technologies, has failed to provide key data on which the safety assessment process depends.

The US Food and Drug Administration (FDA) is currently considering whether to approve this salmon for sale to US consumers. If it becomes the world’s first commercial GE animal, the approval of the AquAdvantage salmon, which contains a modified growth hormone gene, will be a technological and cultural milestone. In perhaps as few as 18 months, if AquaBounty has its way, unlabeled GE salmon will be landing on the plates of consumers. So it is a fish that needs to be safe, for the public, as well as for the environment.

Congress has determined that GE animals will require FDA approval and that approval should be based solely on science. Science-based regulation is a narrow ground on which to base societal acceptability but its advantage is that, in principle, it allows the approval process to be orderly, data-based, and transparent, with requirements set out in advance. (In this case, industry guidance can be found at http://www.fda.gov/downloads/animalveterinary/guidancecomplianceernforcement/guidanceforindustry/UCM113903.pdf). There is, therefore, no good reason for an applicant to come to the table with shoddy science or missing data. However, that is what AquaBounty has done. This is a problem, in particular for the FDA, if it wishes to ensure that the approval process for the world’s first GE animal does not set an embarrassing precedent.

Key publication errors

The only peer reviewed publicly available data for assessing the science behind the AquAdvantage salmon is a single paper: Characterization and multigenerational stability of the growth hormone transgene (EO-1alpha) responsible for enhanced growth rates in Atlantic salmon (Yaskowiak et al. 2006). This article, researched and written by AquaBounty scientists, appeared in the scientific journal Transgenic Research in 2006. As it is AquaBounty’s sole publication on the AquAdvantage salmon, one might imagine, given its importance, that AquaBounty would have taken particular care to ensure its credibility and accuracy. It is surprising, therefore, to discover that the paper contains basic errors that prevent the reader from checking the author’s conclusions.

These mistakes can be summarised as follows: the legend for figure 1 (a Southern blot) wrongly identifies two lanes, and the transgene construct itself is mislabeled. In figure 5, the data showing the DNA sequence of the inserted transgene is entirely mangled. In this figure, two separate errors omit sequence stretches adding up to thousands of base pairs. A third error results in a long stretch of sequence being copied multiple times. In addition, the figure legend includes a typo. These errors are described in more detail in a footnote1.

These mistakes mean that the data presented in the paper contradict its written conclusions regarding the nature of the integrated transgene (Yaskowiak et al. 2006). The errors in figure 5 were later corrected in an erratum, but readers are still left to decipher figure 1 for themselves (Yaskowiak et al. 2007).

Has AquaBounty identified the right transgene?

The primary purpose of a scientific paper (assuming the data have been presented accurately) is to allow the reader to verify that the data support the conclusions that are drawn. Yaskowiak et al. claim to have reached two fundamental conclusions: 1) that Aquabounty has created a GE salmon containing a single growth hormone transgene and 2) that this transgene is inherited stably through four generations. Of these two conclusions, the first, that there is a single insertion of the growth hormone gene, is never definitively established in the paper (nor anywhere else)2 and the second depends on the first.

In the paper, Yaskowiak et al. provide reasonable evidence that at least the transgene promoter is present as a single copy. They further claim to have evidence (data not shown) that the downstream regulatory sequence is present only as a single copy. However, the authors never use as a molecular probe the all-important growth hormone sequence itself. Consequently, their conclusions that extra copies or fragments of the growth hormone transgene are not present, and further, that the transgene they do analyse (which they call EO-1alpha) is responsible for the fish’s growth phenotype, are both dependent on extrapolation from the detection of regulatory sequences rather than detection of the gene itself. AquaBounty’s experiments, therefore, leave open the possibility that there are additional undetected copies of the growth hormone gene linked to the insertion site3.

Aquabounty fails to characterise the transgene insertion site

AquaBounty also claims to have characterised the site of insertion of EO-1alpha. The basis for this claim is identification of repeated DNA sequences (that are similar to each other) flanking the EO-1alpha transgene. There are many weaknesses in this claim. For a start, the authors cannot say how much DNA has been lost during transgene insertion or whether the DNA sequences they identify as flanking the transgene were originally found at that genomic location, or even whether they originate from the salmon genome at all. A definitive description of the insertion site would show this, but this description can only be obtained by sequencing the wild-type (non-transgenic) copy of the genetic locus for comparison. AquaBounty does not have this information and so all of AquaBounty’s assertions regarding the insertion site are necessarily guesswork.

The possibility that large pieces of salmon genomic DNA may have been lost from the insertion site, or rearranged, is acknowledged by the Veterinary Medicines Approval Committee (VMAC) in its report to the FDA. In its report, however, VMAC assumes (i.e. guesses) that any sequences lost were “nonessential”. Considering that the entire purpose of transgene insertion site analysis is to establish definitively, by the gathering of data, just this kind of fact, this is quite an assumption.

A consequence of incomplete scientific assessment is assumption-based reasoning

This analysis of the science of AquAdvantage Salmon raises a host of questions. For example, what happened to the peer review process at the journal Transgenic Research4? Why does AquaBounty stop short of establishing that there is only one growth hormone gene, and again fail to establish conclusively that there is limited genetic damage from the insertion? Is AquaBounty simply cutting corners, or do they have something to hide?

The most pertinent issues, however, are arguably for the FDA, since it is the federal agency charged with protecting the public. First, inadequate molecular characterisation means that there is no definitive description of the transgenic event contained in the AquaBounty Salmon. The FDA, ultimately, does not actually know what it is being asked to approve.

Secondly, without an accurate molecular characterization of the insertion site, the effectiveness of the approval process is compromised. For example, the phenotypic analysis of the AquAdvantage salmon is weak (VMAC’s report to the FDA). VMAC justifies this weakness in part by proposing (without presenting any supporting data) that a simple insertion site implies a low probability of unanticipated consequences (VMAC’s report to the FDA). Since the simplicity of the insertion site was never actually established, this is a hypothesis that rests entirely on assumptions and not data.

Thirdly, although the FDA has not reached a final decision, it is believed to consider that labeling of the AquAdvantage salmon is unnecessary because it is not “materially” different to a wild-type salmon. As a Biotechnology Industry Organization representative put it in the Washington Post “Extra labelling confuses the consumer because it differentiates products that are not different”. To be credible, this logic presupposes that someone qualified has actually looked for differences and not found them. Characterisation of the insertion site is the first and most basic step in this process. AquaBounty and the FDA have bypassed this scientific hurdle and settled for assumption-based reasoning.

Perhaps it was the same entrepreneurial spirit that motivated Congress to determine that ethics, morals and wider socioeconomic questions should be left out of the GE approval process, that also motivated the FDA to decide that they could leave out the science as well?

A meaningless standard?

This analysis has demonstrated basic weaknesses in the scientific support for any approval of AquaBounty’s AquAdvantage salmon. One could make yet more assumptions and argue that these lapses are unlikely to have serious consequences in the real world. For example, even if there is another growth hormone transgene present, it is not probable that it would affect food safety or the environmental consequences of an AquAdvantage salmon escape. However, it is our opinion, with so little data available about this salmon, that any such conclusion is grossly premature. Moreover, as the Consumer’s Union comments to FDA show there are in fact good grounds to be concerned about the safety of this fish.

One conclusion that can be reached, however, is an important procedural one: the AquaBounty application clearly does not meet the scientific stipulations of FDAs guidance document. The guidance document requests “the number and characterisation of the insertion sites…[defined as] the genomic location in the GE animal” and goes on to say “We consider this component critical” and even later “You should fully characterize the final stabilized rDNA construct” (FDA’s guidance for industry). Given this wording, it is surprising that FDA’s VMAC committee has interpreted AquaBounty’s data as being more than sufficient.

As the very first application for a GE animal, the FDA’s response to the AquAdvantage salmon sets a precedent. It must now decide whether it wishes to stand by its original science-based guidelines or approve the AquAdvantage salmon. FDA’s response will be interesting because this salmon is attracting a lot of attention. This is not just because the AquAdvantage salmon is a GE animal, and not just because most other commercial GE organisms are animal fodder or ingredients for processed food. The probable explanation of why this salmon is a prominent topic of conversation is that salmon is the meat of choice of a significant and well-connected social grouping: well-educated consumers who consider themselves health-conscious.

In our complex world, where the political messages coming from national capitals are either mixed or manipulated, voters search for bellwethers, actions that give simple and clear clues to their leaders’ inclinations and intentions. Approval without labeling of the AquaBounty salmon would send a very clear message and might just turn out to be an unexpectedly big political mistake.

Written by Jonathan Latham and Allison Wilson of The BioScience Resource Project

Footnotes:

(1) The first data figure (Southern blot; Fig 1b) describes a Southern blot analysis designed to determine the number of copies of the transgene integrated into the salmon genome. There are seven lanes on the blot, including the marker lane. The second and third lanes are labeled incorrectly. Lane 2 is mislabeled as lane 3 and lane 3 (the second data point) is mislabeled as lane 2. This error can be spotted by logic alone: DNA cut by two enzymes cannot possibly be longer than DNA cut by one, when one of the enzymes is the same. The labeling mistake therefore should have been easy to spot. Further errors are found in figure 5. Figure 5 depicts the sequence data confirming the analysis of the transgene insertion site. We identified three separate mistakes in this figure: (a) except on the first page of figure 5 (page 471), the last two base pairs of every line of sequence are missing. Over six pages this adds up to 476 base pairs, i.e. two out of every fifty base pairs; (b) the sequence extending from base pairs 2618 to 3267 (using the numbering of the transgene itself) is quadruplicated, meaning the exact same data (this time 1,950 base pairs) appears four times within figure 5; and (c) Towards the end of figure 5, 7,653 base pairs, starting just after the growth hormone coding sequence are missing entirely. Both figures also contain “typographic errors”. The transgene construct, for example, is mislabeled once in figure 1. The errors in figure 5. (but not those in figure 1) are the subject of a nine-page erratum published subsequently (Yaskowiak et al. 2007).

(2) The possibility of extra copies is not idle speculation. Other authors have identified complex multiple transgene insertion events in salmon (Uh et al. 2006).

(3) There is unlikely to be an unlinked transgene since the AquAdvantage salmon has been backcrossed six times.

(4) Transgenic Research is a journal that frequently publishes self-evaluations and risk assessments of corporations’ own products