It’s only early October, but a day may soon come when you hear news that makes you feel like a kid on Christmas morning. If you do have Celiac disease, or are living gluten-free, a proposed “magic bullet” will probably soon be available in the form of a drug that may represent a huge step forward in treating Celiac disease and gluten intolerance. So what is this new drug? How does it work? And most importantly, can it be trusted?
The drug, currently known by the name ALV003 is in the FDA’s testing stages and is currently being examined in clinical trials. In fact, the drug that is made by Alvine Pharmaceuticals, is being fast-tracked by the FDA in order to hopefully get it approved and onto the market as soon as possible. The fast-track designation is no doubt in part because there are currently no pharmaceutical treatment options available to Celiac patients.
ALV003 is an orally taken drug that is a combination of two enzymes that break down protein, known as proteases. Basically, the drug breaks down gluten into smaller, less harmful fragments. In vitro, this breaking down of the gluten has led to less immunogenicity. Put more simply, in a test tube ALV003 has been found to break down gluten molecules and make them less likely to induce an immune inflammatory response (which creates the hallmark gastrointestinal Celiac symptoms). But the human body is not a test tube, and what happens in isolation in a test tube in a lab may not be what happens in the human body. Human clinical trials will help to bear out whether or not the drug works like it is supposed to when ingested.
So, even if the drug is approved by the FDA, then what? Is it really the magic bullet that you, the Celiac or gluten-free patient, have been waiting for? I’m not so sure that I would personally trust it for many reasons. For one, the FDA has approved many drugs that it later repeals once more evidence comes out about how ineffective or perhaps even harmful the drug turns out to be. The FDA’s approval of drugs is largely based on short-term evidence, simply because they aren’t going to wait 10 or 20 years for long-term evidence to become available. And the fast-track designation given by the FDA may seem like a good thing if it gets the drug to the open market sooner. But fast-tracking something means less and perhaps shorter clinical trials. It is one thing to study a drug and its efficacy and side effects in the short-term, but so often we find that long-term side effects take a while to manifest. Just because a drug has been shown to be effective and safe in the short-term says nothing about its long-term viability.
And what about ALV003 from a common sense perspective? If you are a Celiac or gluten-free patient, when you do ingest gluten, your body reacts as though it has been significantly damaged and poisoned. Maybe that’s your body telling you something? For whatever reason, your body views gluten as a harmful substance. So if ALV003 is approved and you are taking it religiously, you are still bombarding your body with a substance it simply doesn’t get along with. If the drug is taken in conjunction with a gluten-free diet, is it wise even then? Notice that it doesn’t break the gluten down into non-harmful fragments, just less harmful fragments. And if your symptoms are well-controlled by a gluten-free diet anyway, is there any need to introduce a drug into the situation? And just like people on cholesterol medication who sometimes feel free to binge on things like prime rib, donuts, and ice cream, perhaps taking ALV003 will give license to Celiac and gluten-free patients to eat some or a little bit of gluten. And as you know, one exposure to gluten can inflame your symptoms and set you back weeks or months in your recovery. Is it really worth it?
From a cynical perspective, ALV003 doesn’t seem to really pass the sniff test either. Pharmaceutical companies are businesses just like any other, and with the tremendous need for a Celiac treatment drug, perhaps the company is only trying to get rich(er) and may not understand the true needs of gluten-free patients. And the fast-track FDA designation means that there is a whole lot of momentum behind the cause. Overall, I would be wary of the new drug, even if approved by the FDA. We don’t know the long-term effectiveness and side effects. Even if clinical trials do show that the drug makes gluten less harmful to the gut, it would still seem to be better to simply avoid gluten all-together. With the growing number of Celiac and gluten-free patients, the clamor and excitement for a new effective drug is loud and strong. But be cautious, things aren’t always as good as they seem and when it comes to gluten intolerance, the margin for error is very small and something that shouldn’t be taken lightly.
Article Courtesy: Andrew Steingrube