Sunday, November 10, 2013

IRT - GM food supplement caused deadly epidemic

Before I get started, I have a confession to make: I love pomegranates. Love probably isn't a strong enough word. I ate 2-3 a day while I was pregnant, to the point that the hubby planted two trees for me (one of which had it's first fruit this year). But it's a "work food". Like crab legs. Or pumpkin seeds. You have to put in a good amount of effort before you can eat the stuff. Anyway, since it's pomegranate season, I've been eating them all the time and I woke up thinking "someone should make a pomegranate that's easier to clean". And I'm guessing I'm not the only one who wishes for this: Wikipedia has a good section dedicated to suggestions on cleaning out pomegranates (including my preferred method of cracking them open under water). Well, according to this review, a genetically modified pomegranate tree is possible because one has already been made to express GFP (green fluorescent protein). It's probably what Sheldon used to make his goldfish glow in the dark. The authors recommend making pomegranate crops that are stress tolerant or have other horticulturally-beneficial genes, but none have been made (although that hasn't stopped people from marketing GMO-free pomegranate juice). None of the suggestions in the review included recommendations on making the fruit easier to eat...

Now, getting onto juicier topics (no pun intended!)

If you've been following this blog, you'll know that I started reviewing the "Health Risks" section on the Institute for Responsible Technology's webpage several months ago. This was due to the fact that numerous anti-GMO webpages were using it as a resource, so I thought I should look into it. Today, I finish its review by covering a section entitled "GM food supplement caused deadly epidemic". I'll be honest here: I started out upbeat and open minded when I started reviewing the IRT's site, but I haven't come across a single valid statement. Consequently, every time I sit down to read from this webpage, I feel the same way as when I think about Jar Jar Binks. Or just Episode 1 in general. A sense of dread and gloom. Consequently, it's only this bowl of pomegranate that I'm currently eating that will get me through this last section.

The segment would have been more aptly entitled "Dietary supplement produced using recombinant DNA technology was associated with a deadly epidemic". Here's the first section directly from the IRT: "In the 1980s, a contaminated brand of a food supplement called L-tryptophan killed about 100 Americans and caused sickness and disability in another 5,000-10,000 people. The source of contaminants was almost certainly the genetic engineering process used in its production." It goes on to state that it took years to "find" the disease and that an investigation only took place because the symptoms were so dire. The IRT argues that there is no monitoring of GMO-related illnesses - particularly long-term effects - and it may take decades, if ever, to identify the source of a problem. I've already reviewed the topic of long term effects of GMOs, so I'll focus on the first part of their argument.

Unfortunately, there are only two citations. The first is to an article on the IRT's webpage and the second is to a book written by one of the founders of the IRT. So neither one are peer reviewed sources. However, Wikipedia has a pretty good entry about this event, with several citations. The disorder is known as eosinophilia-myalgia syndrome (or EMS) and the outbreak took place in 1989, leading to an eventual ban of tryptophan dietary supplements by the FDA. I started by reading a few abstracts for papers that investigated the cause of the EMS outbreak:
  • The abstract for the first paper simply states that they traced the bad lot of L-tryptophan to a single manufacturer from Japan.
  • The second abstract says the same thing (a different population was tested) and hypothesizes that a contaminant was introduced in the manufacturing process.
  • The third abstract says the same thing, adding the point that the incidence of EMS decreased drastically once the product was recalled.
So far, there's nothing about a mysterious genetic engineering contaminant. There's reference to a contaminant, but no mention of when/where/how it could have been introduced.

If I were to magically design the perfect pomegranate, I think it would peel like a tangerine.

The next item I read was a 2001 report by the FDA (I thought it was odd that the IRT article did not mention the FDA's involvement). The FDA report was written up to clarify their position on tryptophan supplements. The report stated that 37 people died as a result of the bad batch of tryptophan. They state that there were numerous impurities in the batch, several of which were associated with EMS, but no one really knows how. They pointed out that not everyone who took the contaminated supplements got EMS, so there may be a genetic predisposition/factor involved as well. Again, nothing about a contaminant from the genetic engineering process.

I'd also magically make that white fluffy stuff disappear so that the seeds would just drop out. I looked it up and the white fluffy membrane doesn't have a specific name. You'd think it would have an uber-geeky scientific name.

Next, I found a New England Journal of Medicine article that looked into the whole tragedy. The article points out the fact that the manufacturer in Japan had switched to a new bacterial strain for the synthesis of tryptophan in 1988. In 1989, they made another change in their manufacturing process: instead of starting with 20kg of one of the starting materials, they cut it down to 10kg. During that same time period, some of the batches of tryptophan that they were making skipped one of their filtration steps. The authors find statistical significance between the amount of starting material used with EMS. They also find correlation between the bacterial strain used and EMS. However, they highlight numerous times that they cannot disassociate the bacterial strain used from the amount of starting material used, so they cannot tell the impact of the bacterial strain alone. Then they state: "For this reason, it is possible that strain differences were unrelated to the production of the etiologic [disease causing] agent." They also mention that the manufacturer's tests had shown no difference in the biological and physiological properties of the old and new bacterial strains. So the New England Journal of Medicine does not point to a weird by-product of the genetic engineering process. Also, article sheds a lot of light on the timeline: the first cases of EMS were identified in October 1989 and by early November 1989 the link between tryptophan and EMS had been found. It didn't take months or even years for this to be identified.

I only have two pomegranates left in the fruit basket... I'd better add 'pomegranates' to the shopping list. I wish I could write 'peel-able pomegranates'. I'd pay extra for those suckers.

So here's why I think that this is, by far, the most ridiculous "health impact" on the IRT's webpage and the molecular geneticist in me cringes at the thought that this is even considered a GMO, as defined in the GMO debate. In 1922, the first human patient received an injection of insulin isolated from a calf pancreas, and patients had to rely on insulin isolated from animals until the 1980's. To make human insulin, the DNA sequence of insulin is inserted either into bacteria or yeast, which then start making the protein. It is isolated, purified, and sold to millions of patients worldwide who rely on this lifesaving technology. Patients are not exposed to the bacteria or the yeast. These organisms are just used in the manufacturing process of insulin to make it scalable and, often, easier.

Statistically, insulin is a drug that me or someone I love and care for will probably end up taking in our lifetimes. And insulin isn't the only drug produced this way. Countless other drugs and dietary supplements,  including tryptophan, are produced using recombinant DNA technology (this article highlights that malarial drugs are being made this way). So why is the IRT focusing on this story about tryptophan and EMS? I really can't explain it.

In my perspective, the EMS outbreak highlights another issue altogether: the need to have more stringent regulations in the world of dietary supplements. The quick sequence of changes introduced in the manufacturing process of tryptophan and their immediate rollout to the market would have never even been contemplated if it were regulated as strictly as pharmaceuticals. Or if they wanted to make the changes, they would have had to perform rigorous testing to demonstrate that there's no change in the function of the product. Cutting back on starting material by 50%?? Changing the strain of bacteria used once the product is in the market? Utter craziness!! Please do not misconstrue this and think that I'm implying that the pharma/clinical world is perfect. Far from it. I worked on my first project in regulated markets this year and learned first-hand of the craziness that exists. But at least the regulations and trials that they have to go through put a few checks and balances in place.

Whew! With that rant I finish the review of the IRT's health risks. My conclusion: they focus on fear-mongering. Most statements were misleading or misrepresented the studies, and several statements were outright lies.

Till my next post, I'll continue enjoying pomegranate season and keep my fingers crossed that someone out there is working on a peel-able version of the fruit.

PS: After reviewing this, the spouse thought that the pomegranate seeds should be the size of grapes. Pure genius!

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