Thursday, May 26, 2011

The Prospect of a Celiac Vaccine: Part 2

Photo courtesy Stock.Xchange / Little Man
In Part 1 of this week's series on the prospect of a vaccine for celiac disease, I looked at the company and the researchers behind Nexvax2, the coverage their study has garnered, and the methods and results of their phase I clinical trial. In today's Part 2, I take a look at myths, misconceptions, and assumptions surrounding the research, its implications and limitations, and finally, offer my own personal perspective on the prospect of a celiac vaccine.

Vaccine Myth-busting

As I've scoured the Internet, reading the original research, then reading the websites reporting on the research, then reading the blogs reacting to the reports that discuss the original research, and finally reading the blog comments responding to the blogs reacting to the reports that discuss the original research (whew!), I've noticed some common myths, criticisms, misconceptions, and assumptions creep into the discussion. It's not especially surprising, given how far removed a blog comment is from the original research, once the information has passed through several intermediate hands, including websites and bloggers. So, I thought I'd address several of the more common concerns.

1. Vaccines contain toxins, including metals. There's no way I'm putting that in my body.

This concern is not specific to the Nexvax2 vaccine. It doesn't matter whether we're talking about a potential celiac vaccine, a vaccine that cures cancer, or a vaccine that cures a hangnail. This is a much bigger general controversy. Some people say vaccines are perfectly safe and save millions of lives. Others say vaccines make people sick and may cause or trigger conditions such as Autism Spectrum Disorder. I'm not opening up that Pandora's Box in this blog post. Just remember that this concern is not specific to Nexvax2.

2. Great, another vaccine to add to the already-long list of vaccines we give our children when they're young.

Umm, no. In Part 1 of this series, I talked about how Nexvax2 is NOT a pre-emptive vaccine used to inoculate someone against getting a certain disease. We're not going to start wholesale vaccinating babies across the board against celiac disease. That's not how the vaccine works. It's a therapeutic vaccine, given to patients with diagnosed HLA-DQ2 active celiac disease.

3. Yeah! A cure for celiac disease!

Not so fast. Nexvax2 is neither a prevention of celiac disease, nor a cure for celiac disease. Whether you get the vaccine or not, if you have celiac disease, you will continue to have celiac disease. It's more appropriate to think of the therapeutic vaccine as a treatment option, alongside the gluten-free diet, for celiac disease. Whereas the gluten-free diet keeps you healthy and manages symptoms by keeping the offending gluten out of your body, the Nexvax2 vaccine would keep you healthy and manage symptoms by teaching your body not to react to gluten when it does enter the body. That's different than saying your celiac disease is gone. In fact, researchers anticipate that if the vaccine is eventually approved by the FDA, the treatment protocol will require weekly or monthly injections in order for your body to maintain its gluten tolerance.

4. Sign me up! Where can I get the shot?

You can't. The vaccine is still in the early-middle stages of clinical trials. As a matter of fact, researchers still have to tackle phase II, during which they'll see if the vaccine actually works. (Kind of important to know...) Indications are good that it will, or might. But at the earliest, and assuming no snags in the clinical trials and approval process along the way, we might see the vaccine available in 2017, six years down the road.

Implications and Limitations

For certain, Nexvax2 is big news, and deservedly so. It's another important milestone in science's understanding of how celiac disease operates in the body, and how we might treat it with options other than a gluten-free diet. But the vaccine does have its limitations. First and foremost, it's not for everyone. Rather, as I said earlier, it's for people with diagnosed HLA-DQ2 celiac disease. That's a sizable chunk of the celiac community, but hardly all of the celiac community, nor does it represent the broader gluten-free community. For example, the vaccine won't necessarily help:
  • Non-HLA-DQ2 celiacs. Scientists once thought that you had to have the HLA-DQ2 gene in order to have celiac disease. They're now finding that's not the case. In fact, they're increasingly discovering an interesting phenomenon, where patients test negative for both HLA-DQ2 and -DQ8, and yet test positive for celiac disease. This phenomenon is especially prevalent among men.
  • People with gluten intolerance and other forms of non-celiac gluten sensitivity.
  • People with wheat allergy.
  • People using a gluten-free diet to treat other conditions, such as Autism Spectrum Disorder.
  • People on the Paleo diet, who adhere to a gluten-free (and grain-free) diet.
  • Athletes who adhere to a gluten-free for its anti-inflammatory properties.

My point is, the vaccine's early clinical trials may justifiably garner attention, but it's hardly the be all, end all for the gluten-free community.

To Vaccinate or Not?

For those people with HLA-DQ2 celiac disease, that still leaves open the hypothetical question - should the vaccine eventually receive approval and make it to market - of whether to get the vaccine or not. It's not an either/or decision. You could of course skip the vaccine and remain on a gluten-free diet. And in theory you could get the vaccine and supposedly eat gluten again. But there's also a middle ground where you can both get the vaccine and remain gluten-free, a sort of redundant back-up system.

There's also a much bigger, more fundamental question about whether or not the vaccine treats the symptom, rather than the cause (in my opinion, the vaccine strikes a middle ground between those two extremes). And about whether or not we (as human beings, not just people with celiac disease or other gluten issues) should be eating gluten in the first place.

There's mounting evidence that gluten may be bad for people in general. For two examples, consider that adherents of the Paleo diet (I'm not one of them...) argue that humans aren't meant to eat any grains, gluten-free or gluten-ous; and consider that elite athletes are increasingly flocking to the gluten-free diet, because many find that gluten has inflammatory properties for the human body, and that maintaining a gluten-free diet enhances athletic performance.

But for more startling evidence, consider these facts: 1) Rates of celiac disease in the United States have been on the rise for decades, and that rise coincides with increasing per capita consumption of wheat and wheat products. 2) In countries around the world traditionally based on naturally gluten-free diets, as those traditional diets have become influenced by Western diets and have started adding gluten to diets that never had it before, researchers are seeing rising rates of celiac disease in places that never had it before, and as long as rates of gluten consumption in those countries continues to rise, researchers expect the celiac disease rates to rise in kind.

In both cases, researchers note that the genetics of the human populations in question haven't changed. Instead, they point to environmental factors - and in particular, gluten in the diet - as the most likely culprit for the rising rates of celiac disease. Which brings me back around to the central question: should we be eating gluten in the first place, even if we don't have a diagnosed condition such as celiac disease?

With that in mind, I can't help but draw this analogy with the potential celiac vaccine... It's not a perfect analogy, but it's still a good relevant example: Many Americans today are obese (some morbidly so), have high blood pressure, and have high cholesterol. By and large, all of these conditions could be treated with nothing more than diet and exercise. Treat the cause, rather than the symptom. And yet millions of Americans instead opt for medication to treat their blood pressure, medication to treat their cholesterol, medication and surgical intervention to treat their obesity. (And yes, I understand that there are certain people for whom these treatments are appropriate...) For the vast majority, though, people have chosen to treat the symptom with medicine, while continuing to pump their body full of the thing that's making them sick in the first place.

Would we be doing the same thing with a celiac vaccine that lets us eat gluten again? Would it be more appropriate to avoid gluten in the first place, and stick to a gluten-free diet? Would we - in some sense - be turning ourselves into feedlot cattle, which are fed something they're not normally meant to eat in nature (grains), which their body revolts against, and which are then are given medicine (antibiotics and other drugs) to keep them alive and somewhat healthy?

A Personal Response

At this point, I'm starting to editorialize a bit, treading water in the "personal response" end of the pool, rather than wearing my more objective journalistic hat, so I might as well tell you how I feel about the prospect of a celiac vaccine.

I genuinely and sincerely praise the researchers who've done some amazing science in pursuit of a therapeutic celiac vaccine. And I also admit that I can foresee a number of instances in which having the celiac vaccine would be a benefit: To eat a beloved gluten treat (perhaps a stout beer, or a flaky croissant) for which you haven't found a suitable gluten-free alternative. To make business trips easier. To give options when traveling, or eating at a festival where there may literally be no gluten-free option at all. For children in a school environment, where they may be too young to understand all the places where gluten hides, be too young to look out for themselves, or be too young to not resist wanting to eat the same thing that all their friends are eating. In all of these cases, having the celiac vaccine in your back pocket is certainly a plus.

But in the grander scheme of things, I'm just not that excited. In my work with the NFCA, my personal interest has always been with the awareness end of things, rather than the research end. I've been less interested in finding a "cure," and more interested in getting people diagnosed, seeing them switched to a gluten-free diet so they feel healthy and whole again. Still, over the last few days, I've been wrestling with the question of why I'm not more excited. Isn't this what the gluten-free community has been waiting for? Maybe... I'm not entirely convinced.

I think it's because, at a personal level, I don't feel a need for a vaccine. The vast majority of the time, I find the gluten-free diet to be easy. I'm healthy. I'm happy. In other words, life is good. The vaccine wouldn't change that.

And so I'm watching these developments... Cautiously. A bit skeptically. Curiously. Interestedly. Optimistically. And ultimately, conflicted.

But how about you? Whats you're take on it?

- Pete


Missy said...

I tend to agree with you, Pete. Since my son was diagnosed with Celiac Disease 1-1/2 years ago, the rest of the family has also been decreasing the amount of gluten we ingest, and I have noticed a difference in how I feel. As time goes on, I learn more about how damaging gluten can be to our bodies, and so I am not excited to hear about the vaccine, either, as I think people will use it to continue down the path of unhealthy eating. Thanks for your thoughtful insight into this topic.

Anonymous said...

Thanks for your post with valuable information and heartfelt reflection.

My wife has Celiac Disease. It makes every church potluck, every restaurant trip, every overseas visit, like playing Russian Roulette.

She may choose to stay GF forever...but truthfully she has limited ability to do so, short of always refusing food she/I didn't prepare. This vaccine is like wearing a seat belt. No one expects a car wreck. No one expects the food preparer in the kitchen to make a mistake. But this happens.

peterbronski said...

Hi Missy... Thanks for sharing your perspective. I know exactly what you're talking about. While Kelli is now 100% gluten-free, a few years ago she was fully gluten-free in our home, but would occasionally eat gluten at business lunches. She would notice a different in how her body responded to it once she had mostly eliminated it from her diet. It got us thinking.

Hi Anonymous... Thanks, also, for sharing your wife's story. You certainly describe several scenarios where safely remaining gluten-free is indeed a risk not unlike that of Russian roulette. Your seatbelt analogy, I think, is similar to my sentiments when I wrote that someone might choose to remain gluten-free but get the vaccine anyway, as a redundant backup system. As you said, no one expects a car wreck, but sometimes they happen.

Cheers, Pete

Theresa said...

Thanks for the great article!
I've got really mixed feelings about this vaccine. On one hand, I sometimes feel like I'd do anything to be able to eat whatever I want again. Life would be so much easier than it is now. But then again, I'm really sceptical about what this vaccine really does. My body is programmed to reject gluten so I seriously doubt the ability of this vaccine to reverse that. What if it treats the symptoms, but my body still gets damaged somehow? Perhaps the villi are still fine, but there are other things that gluten can effect. I don't know if it's worth the risk.

However, if there was a special treatment we could take just before difficult situations, like travel or eating dubious food, I'd be all for it! It would give us coeliacs such freedom and relief from our fears. :) I suppose that vaccine would do that... but if I took it I'd be more likely to binge on gluten than anything else!

jgribble said...

Another really interesting piece of reporting, Pete. I enjoyed both the facts and your editorial comments! said...

I have been struggling with all of this too, Pete. I have been diagnosed since 1995, so I am pretty well adjusted with my gluten free life. BUT, traveling and eating out can still be so difficult and it sure would be nice to have a safety net.

I have been especially worried about this now since I was recently diagnosed with another AI disease and wondering how well I have really been doing eating GF all these years, ya know? Despite annual blood work that says I am doing well, another AI disease pops up. How much is it related? Dunno. Grrr.

Melissa Davlin said...

Like others, I would be open to getting the vaccine as a safety net for incidental gluten exposure, but I'd like to think I would still adhere to the gluten-free diet.

I have to admit, though, that the idea of eating at my favorite pizzeria or drinking my husband's home-brewed beer is attractive. I've never cheated on my gluten-free diet, but I'd be a lot more likely to with the vaccine. That's not a good thing, and it would probably be better if I avoided the vaccine and the temptation that would come along with it.

Anonymous said...

I am definitely looking forward to the vaccine and hope that I will be one of the folks it will help. Travel is a struggle. Grabbing a quick, inexpensive sandwich isn't an option. It has to be either cook my own food on vacation or have expensive meals in restaurants. And with restaurants, I can't necessarily go where the rest of the group is going and sometimes have to go somewhere by myself. Also, I miss a lot of work functions because they're held in restaurants that don't have options for me. I want to leave behind this life of being left out. I've found being gluten free to be rather lonely.