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Low Dose Immunotherapy Status
in the United States
EPD was administered in the United States
for several years under an Investigational Review Board (IRB) study. The
IRB study showed that EPD was extremely safe (safer than "conventional"
allergy shots) and effective for 80% of the people treated for most allergic
conditions. When the IRB expired, application was made with the FDA for
Investigational New Drug (IND) status for EPD. The IND application was
denied and in April, 2001 the FDA "shut down" EPD.
This FDA action abruptly ended all EPD treatment
in the United States, leaving thousands of desperately ill citizens with
no access to any effective treatment for their problems (Most EPD patients
are taking it because other treatments have failed to help them). When
something essential to life is taken away, we must act, so a patient group
called The EPD Patient Alliance was formed. A letter-writing campaign was
organized, and many, many EPD patients wrote to the FDA, their congressmen,
and the President.
During the summer of 2001, as it became apparent
that the British manufacturer’s IND application was going to take some
time to be submitted and would probably exclude most former EPD patients,
some patients researched the possibility of directly importing EPD for
personal use. The FDA website section on "Personal Importation and Use
of Unapproved Products" said that in cases of dire need the FDA may allow
patients to import for personal use a less-than-three-month supply of unapproved
products in baggage or by mail with the appropriate documentation. Therefore,
personal importation seemed like a solution to the problems. However, the
FDA had already put EPD on "Import Alert" and told us that this makes it
"illegal" to import EPD for personal use.
At this point, things looked pretty grim for
EPD patients, especially those who live far from the Canadian border. However,
as Christian EPD patients petitioned the President, the FDA, and members
of Congress for help with our problem, we also remembered Who is really
in control, and petitioned Him as well. "The king’s heart is in the hand
of the Lord; He directs it like a watercourse wherever He pleases." (Proverbs
21:1) We formed a prayer group that is still "up and running." If you are
interested in praying with us, email us at firstname.lastname@example.org.
For more about this, see "Go to the top!."
Our prayers were answered, and an American-made
alternative to EPD now exists. This injection is called LDA (for Low Dose
Allergens) and is based on the same principle as EPD, although it is in
many ways different and improved. LDA is compounded in a licensed American
pharmacy from American-made antigens manufactured in FDA licensed laboratories.
The antigens used are the same as in conventional allergy desensitization
shots, but in very low concentrations. In addition to common allergens,
LDA contains uniquely American antigens which are not present in EPD such
as cottonwood, sage, mountain juniper, some New World evergreens, American
perfumes, "new" foods such as avocado, etc. Because LDA is so new, there
is not much data available on it yet, but many patients I have talked to
have had very good results with LDA. My personal experience is that I had
mediocre results on food allergies in over 35 shots during 9 years of treatment
with EPD. It was always three steps forward and then two steps back; with
some shots I’d be able to add a food or two to my diet, and then I might
"lose" it with the next shot. After 9 years of treatment, I was no longer
starving, for which I was very grateful. My diet consisted of game meats,
less-common kinds of fish, some nuts, some vegetables, and some fruits.
After one shot of LDA I have been able add several new foods to my diet
including some very "normal" ones such as legumes and dairy products. My
son is also doing very well with his first shot of LDA. In fact, he is
doing better on pollen than he did with EPD. In the July-August "Mastering
Food Allergies" article on EPD, it was explained that one of the reasons
EPD worked better than other types of desensitization was because all of
the patient’s allergies were treated at once. In my opinion, I expect LDA
to work better than EPD for American patients because it is designed to
"fit" the allergic exposures Americans experience rather than the exposures
that the British experience.
A new IND for EPD was submitted to the FDA
in the fall of 2001 and was accepted. The IND study, which will be for
seasonal hayfever only, is expected to begin in 2003. It will probably
be several years before EPD could be approved for food allergies.
This website is updated yearly, at most. If
you are have questions about the current status of LDA and EPD or need
more information about obtaining treatment, email us at email@example.com.