New Drug is in Clinical Trials
Dr Robert Anderson, PhD from Australia announced that after several years of research his vaccine was ready for a Phase I trial.
I remember meeting Dr Anderson a few years ago at a National Foundation for Celiac
Awareness conference ,where he shared with me his goals about this research.
The study was composed of 34 celiacs, 19 people of whom
received the vaccine while 15 received a placebo of saline water.
The participants followed a strict gluten-free diet and were
of the DQ2 genotype (genetic profile) for celiac disease. DQ2 is the most
commonly known gene for celiac and it is estimated that 80% of celiacs carry
the gene.
The goal of the phase I trial was to assess the weekly
injectable vaccine for safety, tolerability and efficacy. The vaccine is
derived from wheat and barley and contains 3 peptides (or protein fragments)
that commonly create an immune reaction.
What Were the Side Effects?
The side effects of the 19 people tested included:
GI distress, typically similar to
that felt with inadvertent gluten ingestion.
One individual had to withdraw
from the study because the digestive complaints were too severe.
7 out of the 19 suffered from
nausea,
2 suffered from
severe nausea and
2 others vomited
shortly after receiving the injection.
The mechanism of the vaccine is to target the immune cells
(T cells) that are specific for celiac disease and have them instead be created
specifically against the vaccine. In turn these T cells, once specific immunity
is developed, create an immune substance called gamma interferon, which is
critical in developing a specific immunity. This mechanism would be similar to
the one used in allergy shots where someone is desensitized to something
they’ve been reacting to. The injections are designed to prevent the typical
immune reaction of the offensive substance from occurring.
As a side note, gamma interferon, when aberrant, is
associated with autoimmune disease, meaning the immune system gets
overstimulated to a point where it starts attacking the body itself instead of
the foreign agent.
Four out of Nineteen Participants Had a Positive Response
Only 4 of the 19 participants generated these desired type
of T cells, although Dr Anderson seemed pleased with this response, since he
considered the trial a success.
There are considered to be over 60 peptides (pieces of
protein) that are responsible for the reactions against gluten. This vaccine
includes only 3 peptides, but its creators feel that these account for the
majority of the negative reactions that are seen.
As mentioned above, this particular vaccine is only
applicable for those who carry the DQ2 genes. In regard to celiac disease, we
know that patients with the gene DQ8 can also develop the disease and it is
thought that many other genes are involved as well. DQ2 is the most prevalent
so it definitely made sense that a gene specific vaccine would be created for it,
but the vaccine would not be universally effective on all celiacs.
Of course this vaccine does nothing for those suffering from
gluten sensitivity, who have a different genetic profile. But gluten
sensitivity is a newer player in the gluten intolerance arena, so no big
surprise that a vaccine would focus on those with celiac disease.
With 4 individuals out of 19 generating the desired T cell
response, that puts the “success” rate at 21%. I personally wouldn’t consider
that a success, but I’m often surprised at what is acceptable in the drug and
vaccine field.
While the trial was considered successful, even if all goes
according to plan there would not be a vaccine on the market before 2017.
So what are my personal conclusions? From the science perspective I share Dr
Anderson’s excitement in developing a mechanism that causes the immune system
to react in the way he had envisioned it.
But from a clinical perspective I have concerns. There has
never been a drug or vaccine with zero side effects and I’m sure this one,
should it make it to market, will be no different. What will these side effects
be and how long will the vaccine need to be on the market before they are
realized? No one yet knows.
Is a 21% Positive Outcome Really Considered Effective?
The “effectiveness” according to this trial was 21% of those
who received the vaccine. But remember that the vaccine is only appropriate for
about 80% of the celiac population. With its current efficacy, a population of
100 people would only find 17 potentially benefiting from this vaccine,
excluding any side effects.
With No Drug on the Market, What Should We Do in the Meantime?
So where does this leave us? No different really than we
were before this data came out. The truth of the matter is, that at this point
and likely for several years into the future, our goal must be timely diagnosis
of celiac disease and gluten sensitivity, gluten elimination, and an effective
program to heal the gut while reversing as much gluten-induced damage as
possible.
This is what we specialize in at my clinic HealthNOW Medical Center. Since writing
our book The Gluten Effect” we have come to realize the overwhelming demand
for a clinic that would provide such a service. In response to that need we
created a destination clinic so that we could see patients from across the
country as well as internationally. This has been very successful and our
destination clinic patients have enjoyed dramatically improved their health.
Need Help? We're Here for You!
If you felt as if I was describing you above, you are not alone. As I mentioned earlier, adrenal fatigue/exhaustion is almost epidemic. If you would like assistance and don’t have a clinician whom you feel can assist you, consider contacting us for a FREE Health Analysis. We are a Destination Clinic and treat patients from across the country and internationally. We would be delighted to help you as we have been doing so for over two decades.
Visit us at www.RootCauseMedicalClinic.com. If you have questions or need any help, I’m here for you! Call 408-733-0400.
I look forward to hearing from you.
To your good health,
Dr Vikki Petersen, DC, CCN, CFMP
IFM Certified Practitioner
Founder of Root Cause Medical Clinic
Co-author of “The Gluten Effect”
Author of the eBook: “Gluten Intolerance – What You Don’t Know May Be Killing You!”
If you felt as if I was describing you above, you are not alone. As I mentioned earlier, adrenal fatigue/exhaustion is almost epidemic. If you would like assistance and don’t have a clinician whom you feel can assist you, consider contacting us for a FREE Health Analysis. We are a Destination Clinic and treat patients from across the country and internationally. We would be delighted to help you as we have been doing so for over two decades.
Visit us at www.RootCauseMedicalClinic.com. If you have questions or need any help, I’m here for you! Call 408-733-0400.
I look forward to hearing from you.
To your good health,
Dr Vikki Petersen, DC, CCN, CFMP
IFM Certified Practitioner
Founder of Root Cause Medical Clinic
Co-author of “The Gluten Effect”
Author of the eBook: “Gluten Intolerance – What You Don’t Know May Be Killing You!”
Founder of Root Cause Medical Clinic
Co-author of “The Gluten Effect”
Author of the eBook: “Gluten Intolerance – What You Don’t Know May Be Killing You!”
