Archive for the ‘LDA’ Category
All about LDA
Written by Rick Neubrander
History of LDA.
The origin and roots of Low Dose Antigen (LDA) therapy are found in Dr. Leonard McEwen’s creation of Enzyme Potentiated Desensitization (EPD) in the 1960s. EPD attempts to eliminate a patients’ allergic reactions by injecting minute doses of numerous allergens in combination with an enzyme called beta-glucuronidase.
EPD was an allergy treatment which was allowed in the United States between 1992 and 2001 through the IRB process. It was shown to be highly successful for a wide variety of allergic as well as non-allergic immune system illnesses. In April of 2001, the FDA intervened, and no longer allowed the 50 or so U.S. physicians who were using EPD to import the materials from the U.K. The reason that the FDA gave the physicians was that they now must apply for an IND (investigational new drug). Such an endeavor costs drug companies hundreds of millions of dollars and years of research studies, something that the fewer than 100 U.S. EPD-providers could do. This was an unnecessary move by the FDA because EPD fell under the grandfather clause due to the fact that it had been safely and effectively used since the mid ‘60s. However, the FDA held firm to their position. Because of their actions, thousands of patients who had been benefiting from EPD shots were now stranded without appropriate medical assistance as there was no other treatment that effectively provided them with the same level of relief that they had been receiving from EPD.
Fortunately for the patients and physicians alike, Dr. William Shrader from Santa Fe, New Mexico, principle investigator for the EPD IRB, Director of the U.S. EPD Society, and the physician who first brought EPD to the States in the early ’90s worked diligently to create an American version of EPD. (To those on this blog who are patients of Dr. Neubrander, it may be of interest to know that Dr. Neubrander, always an innovative thinker for his patients, hosted the first EPD Physician Training Seminar at his clinic in Princeton, N.J. in 1992.)
In 2002, Dr. Shrader began to offer his version of this allergy treatment, something he called low dose allergen therapy or LDA. This therapy has many similarities to EPD. For example, like as with EPD, Dr. Shrader’s LDA therapy injects minute doses of various allergens in combination with the enzyme, beta glucuronidase. Also, as with EPD, LDA is administered to patients about once every sixty days at first, then less often as the patient improves clinically.
What is LDA and how does it work?
LDA consists of 4 different cocktails of numerous antigens in fixed combinations enhanced by including a minute dose of chondroitin sulfate as well as the enzyme beta glucuronidase. It does not contain any foreign proteins, adjuvants, or preservative as found in vaccines and other types of injections. The LDA shots are produced once each month by one specific compounding pharmacy that Dr. Shrader has trained to produce the shots exactly the same month-after-month. In addition, the shots are always fresh because they are only produced and distributed once a month, therefore they are never close to expiring when one receives his or her shot. However, though the FDA “allows” LDA to be used under regulations that apply to compounding pharmacies, it is not an “FDA approved” allergy treatment and therefore not suitable for billing to insurance. (To clear a FAQ: thousands of devices, therapies, and treatments are not “FDA-approved” but safely and effectively are used by millions of Americans every day.) The reason you most likely have never heard of LDA is because the single compounding pharmacy that makes it for the limited number of U.S. physicians and their patients who use it are not allowed to produce it as a retail product, something that the FDA does frown upon and will therefore shut the operation down. With that being the case, the only way you will hear about LDA is by word of mouth from other patients who have experienced it or by one of the few physicians utilizing it in their practice.
The mixture is injected just under the skin, usually in the forearm. The volume of the injection is extremely small, only 0.05 mL. What occurs next is the “immune system ‘sentry’ cells” migrate to the scene to investigate. Once they investigate, LDA seems to work by stimulating the production of T-suppressor cells, ultimately shutting down overactive allergic responses. Thus, LDA activity appears to be primarily cell-mediated, which creates a much longer lasting desensitization than conventional immunotherapy. Typical LDA therapy is repeated initially every two months for several injections (how soon a person can move from more frequent to less frequent shots varies greatly, based primarily on their personal condition) and then less often with time as the patient experiences fewer symptoms that last for shorter amounts of time
LDA immunotherapy is used to treat all types of allergies and immune/autoimmune system problems. This includes, but is not limited to sensitivity and intolerance to foods, allergies to airborne and environmental allergens (pollens, dust, mites, dander, and molds), and even various chemicals problematic in patients who have “multiple chemical sensitivities.” In addition, it has also been useful for many chronic diseases and auto-immune problems that are beyond the scope of this blog to discuss.
What are the benefits of LDA?
- There is no need for extensive skin testing.
- There is no need for frequent or long office visits.
- LDA can treat a wider spectrum of allergic conditions than can conventional immunotherapy.
- In addition, LDA appears to help some auto-immune conditions and a number of other chronic conditions not typically associated with allergies.
- It is safe and effective for all ages.
- It is safe and effective for all degrees of severity for allergies or sensitivities.
- It has been shown to be helpful for associated chemical sensitivities, chronic illnesses and auto-immune conditions.
- Approximately 75% report some type of an overall improvement or elimination of severe allergic symptoms without the need for additional allergy medications or the use of medications as often as previously used or at doses as high as previously needed.
- Over half of the patients with multiple allergies can stop LDA completely after 16-18 treatments.
- The remainder will be able to be maintained by continued treatment from “booster shots”. The frequency of such booster will vary significantly based on the person’s case. Intervals range from 6 months to several years before a booster is needed.
What are the drawbacks?
- It may take 6-8 injections to achieve sustained relief except for simple seasonal allergies. Failure is not considered until 6-8 injections are given without any benefit.
- DO NOT START LDA UNLESS YOU ARE WILLING TO BE TREATED FOR AT LEAST 12 MONTHS TO SEE IF YOU MIGHT HAVE LASTING RESULTS. Most patients, however, see relief long before then.
- Patients need to avoid various medications and follow a specific diet around the time of injections. (However, for children with autism who are on a very restricted diet already, the diet requirement can often be waived by the treating doctor. However, this depends upon each child’s unique case and must be reviewed in detail with the doctor. As a general rule, about 80-90% of the children on the autism spectrum can have this requirement waived)
- Patients need to receive injections at the clinic. The antigen mixture is sensitive and must be kept in a controlled environment. Thus, the injections cannot be shipped to be administered elsewhere.
For more information you should contact a doctor who uses this treatment and discuss in more depth the details of this treatment.
So many of the children we see at our office have issues other than just autism. Many children regress in the spring or in the fall. This is usually because of the increase of pollen triggering an allergic response and often in children on the spectrum — regression. So what options are out there?
I am including a comment we give to our patients as there are several choices available. This comment will discuss the various options as Dr. Neubrander views them and why he he picks LDA as a treatment for autism.
Dr. Neubrander’s comments to his patients:
When parent learn their child has a significant degree of environmental allergies (also called inhalant or airborne allergies), the parents are confronted with the question, “What’s the best way to help my child?” The options parents have are to do nothing, treat symptoms only, to desensitize with conventional allergy shots or by LDA shots. My bias is definitely to try to desensitize the child, either by conventional allergy shots, provocation/neutralization (P/N), serial endpoint titration (SET), or LDA shots rather than to just treat symptoms.
When one just treats the symptoms, it does nothing to get to the root of the problem and only gives short-term benefits. To desensitize gives long-term benefits and does get to the root of the problem. Provocation/neutralization or SET are hybrids between the two, conventional allergy shots and LDA. I have done all of these and for my ASD population, the best answer, relatively speaking and when speaking in accordance with these children’s fears and phobias and the need for repeated invasive treatment, is to opt for LDA.
Conventional allergy shots need to have a series of skin tests and then many desensitization shots over several years. This is definitely an invasive option that is usually not offered early by an allergist, and even more often not offered to young children. Provocation/neutralization or serial endpoint titration are also invasive and require a series of shots to diagnose the problem over several hours and often a couple of days. Treatment may then use shots or sublingual drops. LDA only needs to determine if allergies exist. Therefore, a simple blood test is adequate. The reason this is OK for LDA is because the treatment “generalizes” for types of allergenic stimuli. For conventional allergy shots, SET, or P/N, the treatment is a one-to-one treatment. You must test for a specific antigen, find the specific treatment dose, and then treat from the same vial, lot, and batch number. One tests for oak and treats for oak. The treatment will not “cross over” and treat for elm or maple or sycamore, etc. By contrast, LDA is able to determine one is sensitive to “tree pollens in general” and therefore desensitize to tree pollens in general, whether they come from New Jersey, Texas, or Oregon. Therefore, LDA offers current and future treatment for a great number of allergens that one is in contact with now, or may come in contact with in the future. This is not the case with any of the other types of desensitization.
For LDA to work “optimally”, it has been taught in the past that one needs to avoid certain things while having others in place. As I look back over my long history with LDA and its precursor, EPD, I see that many things we were taught as facts and absolutes are no longer the case. Rather than to go over such a list, let me make my point for today. In the past we have been taught to follow strict diets for LDA to work. We now know that LDA will work for most patients, specifically for this audience children on the spectrum, without having to be on the strict LDA diet. We have also been taught that patients should avoid taking many types of medications and supplements. What we have learned is that most patients do not have to be excessively strict with this as long as they continue to do the same thing as they were doing. We have learned that often it is just as much a “shock to the immune system” to stop something for a while and then restart it after being off for several days. Dr. Shrader, in personal communications with me on more than one occasion, has said that with LDA there is more to gain by doing it, even if we are not doing it perfectly (something we don’t know and change our minds about year after year) than to not do it at all. I have learned over the years that most of my patients who should not have had any results based on the “we gotta be perfect theory” which they couldn’t be on for a number of reasons did improve.
Therefore, because everything is relative when treating children with autism, and because it is rare for a parent to be perfect with anything they are doing, does that mean they shouldn’t try and scrap the whole thing? Take diet for example — there are almost always infractions so should one not do the diet? Take supplements for example — because a child cannot take everything all the time, or because a child cannot take much of what is recommended most of the time, does that mean one should quit? The obvious answer to both of these things is, “No!” So it is with LDA and “the things” that are taught for how to “make it perfect”. The rules and recommendations apply most to patients who are the most severely ill patients, e.g. those that see Dr. Shrader in New Mexico. For the rest of us, and from talking with other colleagues who give LDA to their patients, we do not want to be cavalier but at the same time we need to be practical with the ASD population and their families. The question arises, “What about vitamin C? If my child takes it, will it ruin the shot?” The answer is that it may blunt the total effectiveness of the shot somewhat, but definitely not make it to where the shot fails. The same can be said for the oils. If one wants, one can decrease the total amount of the supplements being taken by 1/2 or 1/8 for two to three days before up to two to three days after the shot if they have vitamin C or oils in them. However, I can say that if given according to the shot frequency schedule I have outlined for children on the spectrum, and if the shots are given for the full three years according to this schedule, and if one does not break the rules and “walk in the posies”, then the shots will still work for the vast majority of patients. Therefore it is my opinion, biased by years of successfully treating children on the spectrum, that the benefit of LDA, when compared to the other forms of therapy, even when not done perfectly, is a better option.