Looking down the road at potential Celiac Disease treatment, will you be an early adopter? It may seem too soon to consider, but it’s possible that in 5 years there will be multiple pharmaceutical treatments or vaccines for Celiac Disease on the market. By the time they are FDA approved, they will have been through clinical trials involving human study participants that indicate the drugs are relatively safe and will most likely work. Once the drugs are approved, will you run to your doctor to request a new treatment, or will you take a wait and see approach?
Some of us love to be on the cutting edge of everything – fashion, interior design, automotive design, technology, everything. Some of us are even willing to pay dearly for the privilege. One of my graphic designer friends bought an Apple Lisa back in the day. He paid about $10,000 for it although he’ll tell you it was about $20,000. That’s $10,000 for a computer with 5MB (not GB) of hard drive space and a 5MHz processor. I regularly email photos that are 10MB.
This friend continued to buy a MAC immediately when a new model appeared. Then he’d scream often as he zapped the PRAM or held the shift key to disable extensions when he was trying to get the buggy system to boot. He’s followed the same pattern with iPhones. When it comes to technology, he understands he’ll pay more and experience less system stability as an early adopter and that’s okay with him.
I tend to wait a bit longer. I’m not on the tail end of adopting innovation, but I like to give companies a chance to work out a few of the bugs before I jump in with both feet. The internet has made it easy to monitor MAC computer system bug fixes. Armed with that information and knowledge of the nature of the bugs, I buy a bit later than my friend. I feel like I experience less downtime, less frustration, and less expense that way.
When it comes to pharmaceuticals, there’s a whole other level for early adopters to consider – long-term health effects. We often assume that the long-term effects of drugs have been studied before a drug goes to market. That’s not necessarily true. In fact, the more effective a drug is in clinical trials, the less true it may be.
If a drug or vaccine is extremely effective in producing a good outcome, a clinical trial may be ended early. This can mean some side-effects or long-term complications may not show up until after the drug receives approval and is prescribed to patients. There can be a lag in gathering and disseminating information regarding those complications to patients and physicians. The level of risk this presents for patients depends on the specific drug or vaccine.
The FDA website in describing the process of approving drugs states:
“Even though clinical trials provide important information on a drug’s efficacy and safety, it is impossible to have complete information about the safety of a drug at the time of approval. Despite the rigorous steps in the process of drug development, limitations exist. Therefore, the true picture of a product’s safety actually evolves over the months and even years that make up a product’s lifetime in the marketplace. FDA reviews reports of problems with prescription and over-the-counter drugs, and can decide to add cautions to the dosage or usage information, as well as other measures for more serious issues.”
If you’ve watched any network TV recently, you may have seen ads for lawyers representing patients who have received the shingles vaccine Zostavax. Various lawsuits allege the vaccine causes both loss of eyesight and, ironically, shingles. Class action lawsuits have also been filed on behalf of patients who allege they were harmed by drugs including Abilify, Ambien, Avandia, Baycol, Celebrex, Chantix, Crestor, Fosamax, Invokana, Januvia, Lamisil, Lexapro, Lipitor, Pradaxa, Prozac, Ritalin, Serevent, Tekturna, Xarelto, and Zyprexa.
Each of us has to weigh the potential risks and benefits of a recommended medication. If you have life-threatening bacterial pneumonia, the risk of refusing antibiotics most likely outweighs the benefits. If you have prediabetes, the possible risk to your long-term health from medication may not outweigh the benefit of reducing the possibility that you may develop a disease that you may not develop anyway.
With all of that in mind, let’s take a look at the drugs that are being explored for the treatment of Celiac Disease:
An Israeli company owns the rights to a non-absorbable polymer that binds gliadin in the gut and prevents the formation of peptides that trigger an autoimmune response. The drug is not absorbed into the blood and is excreted along with protein from the gut. BL-7010 drug has made it through a Phase 2 clinical trial.
Egg Yolk Therapy
The theory here is that antibodies in the yolk of chicken eggs neutralize gluten allowing people with Celiac Disease to include a little gluten in their diet without suffering symptoms. This therapy would be used alongside a gluten-free diet. It is not believed to be a potential cure.
Larazotide acetate is an oral peptide that reduces leakiness in the intestines so that gluten doesn’t cross the intestinal barrier and trigger an autoimmune response. It would not eliminate the need for a gluten-free diet, but could lessen the effects of accidental gluten ingestion. Phase 3 clinical trials are being conducted this year.
Latiglutenase is a combination of enzymes that was hoped to break down gluten so that damaged intestines could heal. In a Phase 2 clinical trial, participants receiving latiglutenase improved, but so did those receiving a placebo.
The data have now been re-analyzed and scientists believe that latiglutenase may help relieve the symptoms of Celiac patients who are following a gluten-free diet, but still experience discomfort and pain. Last year, the NIH extended a grant for a two-year blind study of latiglutenase. This research will focus on symptom reduction.
There is an enzyme that pulverizes gluten found within a bacterium called Rothia in saliva. Using knowledge of Rothia’s enzyme, researchers found that another bacterium, B. subtilis, produces an enzyme similar to Rothia. Recent research proves that modified subtilisin enzymes adhere to and detoxify gluten in mice. A big plus is that B. subtilis is safely consumed in Japan in the fermented soybean dish natto, making food-based delivery a possibility.
TIMP-Gliadin is a compound composed of the protein particle and Toleragenic Immune Modifying nanoParticles. It sounds like the nanoParticles may alter the body’s immune response to gluten, but I can’t be sure. It’s too early to know much about this research.
This vaccine works much like allergy shots in that a patient develops gluten tolerance through a series of injections. $40 million in funding has been secured for future research and the vaccine will enter Phase 2 clinical trials. The goal of this vaccine is to eventually eliminate the need for a gluten-free diet.
As you can see, the goal of many of these drugs is to reduce or eliminate the effects of accidental gluten ingestion. They would not eliminate the need for a gluten-free diet. Nervax2, BL-7010, and TIMP-Gliadin could possibly achieve the loftier goal of allowing those with Celiac Disease to consume gluten without damaging their intestines.
With these treatments on the horizon, now is a great time to explore whether you are an early adopter, a wait and see type, or someone who is content following a gluten-free diet. The gluten-free diet remains an effective treatment for Celiac Disease as long as you are compliant, so there’s really no wrong answer here. It’s all up to you, your preferences, and your goals!
Waaait, does that make this decision easier or harder? Probably depends on whether you’re an early adopter. I think I’ll wait and see…
Disclosure of Material Connection: I have not received any compensation for writing this post. I have no material connection to the brands, products, or services that I have mentioned. I am disclosing this in accordance with the Federal Trade Commission’s 16 CFR, Part 255: “Guides Concerning the Use of Endorsements and Testimonials in Advertising.”