Sublingual immunotherapy (SLIT), “Allergy Drops” – Our Take on the Subject

Written on January 22, 2014 at 10:23 am, by Neil Gershman, MD

Subcutaneous allergen immunotherapy (SCIT), or “allergy shot therapy,” has been around since the early 1900s. It is considered a well-accepted therapy for allergic rhinitis and asthma. Sublingual immunotherapy (SLIT) has garnered a great deal of attention lately since two sublingual tablet formulations to treat grass allergy were reviewed by an FDA advisory committee. The advisory committee recommended approval of Oralair™ and Grastek™ tablets, which are meant to treat grass pollen allergy symptoms. Although the FDA is not bound by the committee’s guidance, typically approval of the products follows soon afterwards.

While we at the Asthma & Allergy Associates of Florida are always excited about new therapies for allergic disease, we are concerned about what is starting to unfold in the medical community. It is clear that these pharmaceutical company manufactured sublingual tablets are effective, but it is not at all certain that compounded sublingual or under-the-tongue “allergy drops” (liquid treatments made up from allergen extracts that are only approved for injection therapy) will benefit patients. We fear that these drops will gain popularity in that they will be offered as treatment for a larger variety of allergens versus conventional injection therapy. Patients may ask, “Why should I only get treated for grass allergy, when I am allergic to so many things such as dust mite, animal dander, and mold?” There are two main issues regarding sublingual therapy. First, the “devil is in the dosing.” Secondly, there is no good data supporting sublingual therapy for more than one allergen at a time. Thirdly, the delivery system, a tablet versus a liquid, can make a big difference in effectiveness.

Subcutaneous immunotherapy (SCIT), or injection therapy, has been shown in several studies to be a very cost-effective option for treating allergic rhinitis and asthma. It may be a different story for sublingual therapy(SLIT).

As far as the dosing, the most conservative estimates are that the dose needed for effective SLIT is 30 times more than that needed for injection therapy. This can lead to a very high cost to treat a patient effectively. While the raw extract cost for injection therapy may only be a few dollars a month (the majority of the cost being due to the need for administrative staff, nurses, and supervision by the physician), the extract costs for sublingual therapy will end up being extremely high when more one or two allergens is being treated. A ballpark estimate, based on controlled studies of sublingual therapy, would be that the cost of extract alone in treating year-round allergens such as dust mite, cat and dog allergy would be $50-$100 for each allergen. Treating pollens would be slightly less per allergen. The consequence is that the extract costs would be prohibitive for most American patients who are usually allergic to multiple allergens. To this point, in Europe, where sublingual therapy is most popular, patients are typically treated for one allergen. Another hint as to the potential the high cost of this therapy is that the estimate for the cost upcoming grass tablets will be approximately $150 per month, and this is only to treat one allergen.

As far as the second point, there is really no good data to support treating more than one allergen at a time with sublingual therapy, as very few studies have been done. Lastly, as was mentioned above, there may be differences in effectiveness when the allergen is given in different formats (tablet vs liquid). The products on the horizon to be approved in the United States are mostly tablets.

Also concerning to us are claims that sublingual therapy is more effective than injection therapy for allergies. There is absolutely no basis in fact for this. There are some studies showing similar benefit, but the majority of the evidence suggests a greater benefit with injection therapy.

 

There is no question that the idea of sublingual therapy allergy is an attractive one. Because of the lower incidence of allergic reactions with sublingual therapy, patients would be able to treat themselves at home as opposed to getting therapy in a doctor’s office. Also, because of the lower chance of reactions, very young children can be treated. Plus, no needles are involved.

In summary, the question is not whether sublingual allergen immunotherapy works (it apparently does), it is whether physicians are going to use adequate doses in the proper format. For unclear reasons, allergic individuals in the US tend to be allergic to multiple allergens. This results in sublingual therapy being an expensive proposition.

We foresee that SLIT will have a place in certain situations (small children, patients allergic to one or two allergens, moderate to severe asthmatics). Asthma and Allergy Associates of Florida is in the process of deciding the best situations in which to use this type of therapy. We strongly suggest to the public that the be very aware of the limitations of sublingual therapy. For example, we would advise any patient being offered this therapy to specifically ask their physician whether they will be receiving an adequate dose of each allergen.

There is an detailed and referenced review of this topic at the following address:http://www.asthmacenter.com/index.php/News/details/sublingual_immunotherapy/

Protecting food allergic kids in school

Written on December 10, 2013 at 5:48 pm, by Neil Gershman, MD

Here’s an article about food allergies from the Palm Beach Post – with a couple of quotes from me.

Dr. Gershman

New laws aim to save schoolchildren from deadly allergic reactions

By Stacey Singer – Palm Beach Post Staff Writer

Waffles. That’s what sent 8-year-old Emma Serle to the emergency room.

Allergic to five different foods, Emma eats only wheat-free, egg-free waffles.

On a busy weekday morning, her dad, David Serle, accidentally mixed up her waffle with her sisters’ regular ones, and soon, Emma’s stomach hurt. Her throat swelled. Hives appeared. Her mother whisked her to Boca Raton Regional Hospital where she was treated with steroids.

“I was scared,” the little girl acknowledged.

Luckily, she responded quickly to the drugs and was sent home. But food allergies in children can have serious, life-threatening consequences, leading to 90,000 emergency room visits and an estimated 1,500 deaths nationwide each year. Every time there’s news of a child’s death from allergic exposure, David Serle’s mind races.

This fall, 14-year-old Giovanni Cipriano of New York’s Long Island died after eating trail mix he didn’t realize contained peanuts. His parents had given him Benadryl rather than injecting him with his EpiPen, a device that injects epinephrine. He had a heart attack on the way to the hospital.

Katelyn Carlson, 13, of Carmichael, Calif., died after eating a Rice Krispies summer camp treat that she didn’t know contained peanuts. She was administered epinephrine, but too late.

Before them, Ammaria Johnson, 7, had a heart attack in the school nurse’s office in Chesterfield County, Va., while awaiting an ambulance. The school had no epinephrine.

In response to these incidents, new federal and state laws are in place to try to coax school districts to keep lifesaving emergency epinephrine on hand, and ensure that school staff are trained and allowed to use it on children without a doctor’s prescription and without fear of a lawsuit.

That’s because studies show one in four life-threatening allergic reactions happens to a child who had no previous food allergies. Plus, allergic reactions are so unpredictable, and sometimes so sudden and severe, that calling 911 isn’t fast enough.

In Florida, a new state law protects both public and private schools from liability and gives them permission to keep epinephrine pens on hand without a specific student’s name on the drug, said Boca Raton allergist Dr. Neil Gershman, who heads the Florida chapter of the American Academy of Allergy, Asthma & Immunology.

It’s an important step forward, he said, but too few schools are aware of the law.

Palm Beach County School District’s policy hasn’t been updated since 2010.

“In another state, a kid died because an EpiPen didn’t have a name on it, and the nurse was afraid to give it,” Gershman said. “This kind of covers the backside of the nurses and school people to give epinephrine that doesn’t have a name on it to somebody.”

The Palm Beach County Health Department issued a standing order in 2008 giving school nurses the right to administer epinephrine in case of emergency, department spokesman Tim O’Connor said. The agency gives school nurses a vial of epinephrine, syringes and a full protocol for what to do and what dose to give when the tell-tale signs appear: skin warmth, itching, tingling and hives; abdominal pain, vomiting and diarrhea; sneezing; swelling of the face, mouth and tongue; a lump or tightness in the throat; hoarseness, difficulty inhaling, shortness of breath, wheezing; headache, low blood pressure, light-headedness, loss of consciousness, slow heart rate; and feelings of apprehension, anxiety, or “impending doom.”

But the school district’s policy, and state law, requires the drug to be kept under lock and key. The exception is students who have explicit permission from their parent and doctor to keep their epinephrine with them. Epinephrine, also known as adrenaline, is a hormone that can cause the heart to race.

Both the Centers for Disease Control and Prevention and advocacy groups recommend keeping epinephrine in a secure, but unlocked, location, if state and local laws allow it, said Nancy Gregory, a spokeswoman for Food Allergy Research & Education in Washington.

“As the first-line treatment for anaphylaxis (a serious allergic reaction), which can occur suddenly and progress rapidly, epinephrine should be readily available in schools,” she said.

For private and charter schools that don’t have school nurses and may not be able to afford the $250 to $400 cost for a self-injectable epinephrine device, there’s another option.

Mylan Pharmaceuticals, which makes the EpiPen, offers every school — public and private — four free EpiPens a year. The application form is available at www.EpiPen4Schools.com/. A company spokeswoman said more than 30,000 schools nationwide have taken advantage of the program, including 578 in Florida

The issue is hot now because President Barack Obama signed into law the School Access to Emergency Epinephrine Act in November, noting that his daughter, Malia, is allergic to peanuts.

The law gives preference for federal asthma education grants to states that require schools to stock emergency epinephrine and educate school personnel on their use. Only four states have this requirement, according to FARE. Florida isn’t one of them.

Emma Serle’s parents own two brands of self-injectable epinephrine, the Auvi-Q and the EpiPen. Her schoolteacher has one. Her grandparents have another. They keep one at home and one goes with them when they’re out and about, too.

“Emma has severe food allergies to wheat, eggs, tree nuts, peanuts, sesame and shellfish. It’s a lot,” David Serle said.

After the waffle accident, he decided he needed to better understand what his daughter’s life was like. So he put himself on the Emma diet, and challenged others to do so as well. He created a Facebook website, www.facebook.com/eatlikeemma. It was tough, he said. At restaurants, waiters would roll their eyes when he asked detailed questions about ingredients. Chefs would shrug off his concerns. It was a real education, he said.

“You can’t just grab a snack,” he said. “You literally have to plan your meals, which I never did.”

Two months later, Emma is back to gymnastics, enjoying school and planning a family vacation, eating sweet potatoes and chicken for dinner. Is she still mad at her dad for mixing up the waffles? She shrugs.

“I forgive him,” she said.


Food allergy deaths in the news:

Oct. 1: Giovanni Cipriano, 14, of New York’s Long Island, died after eating trail mix he didn’t realize contained peanuts. He had a heart attack on the way to the hospital.

July 26: Natalie Giorgi, 13, of Carmichal, Calif., died after eating a Rice Krispies summer camp treat that she didn’t know contained peanuts.

Jan. 4, 2012: Ammaria Johnson, 7, died after eating a peanut during recess in Chesterfield County, Va. She had a heart attack in the school nurse’s office.

Dec. 17, 2010: Katelyn Carlson, 13, died in a Chicago school after eating Chinese food apparently prepared with peanut products.

 

 

Processed food isn’t great for babies – No kidding

Written on August 21, 2013 at 12:07 am, by Neil Gershman, MD

Here is some unexpected news… fresh fruits and vegetables are good for you. It turns out that babies who ate more fruits and vegetables , and less processed foods, seemed to have less problems with food allergy.

http://www.preparedfoods.com/articles/113039-children-and-food-allergies

Dr. Gershman and Dr. Ramirez on the set for the “Ask the Allergist” segments

Written on July 25, 2013 at 1:42 am, by Neil Gershman, MD

Dr. Gershman and Dr. Ramirez on the set for the “Ask the Allergist” segments.

Dr. Neil Gershman has been elected to be the President of the Florida Allergy, Asthma & Immunology Society!

Written on July 20, 2013 at 3:54 pm, by Neil Gershman, MD

We are very proud to announce that Dr. Neil Gershman has been elected to be the President of the Florida Allergy, Asthma & Immunology Society!

Dr. Neil Gershman is a graduate of the University of Miami School of Medicine. He did his Internal Medicine training at Montefiore Medical Center of the Albert Einstein College of Medicine and his Allergy/Immunology fellowship at the University of California, San Francisco.

Learn more about Dr. Neil Gershman!

Dr. Gershman’s Asthma Inhaler Demonstration Video

Written on December 14, 2012 at 1:22 am, by Neil Gershman, MD

Even though I am no videographer, I think you will get a lot out of watching this video. Just a couple of disclaimers:  1. Watching this video should not take the place of the care and advice of  your physician or pharmacist  2.  This is some disagreement on the “proper” use of inhalers. The video does not depict the perfect techniques. It demonstrates what I believe are adequate techniques that the majority of people are able and willing to perform.

Sublingual Immunotherapy (SLIT), is it a cost-effective alternative to Allergy Shots?

Written on April 17, 2012 at 12:28 am, by Neil Gershman, MD

Sublingual drops, or tablets for allergen immunotherapy (SLIT),  have received a lot of attention lately. Even though there are no FDA approved products, many US physicians are offering this treatment to their patients. We, at Asthma & Allergy Associates of Florida, have chosen to carefully consider using this therapy as an alternative to conventional subcutaneous immunotherapy (SCIT) or allergy shots.

There were several studies at 2012 American Academy of Allergy, Asthma and Immunology that showed the effectiveness of SLIT. However, high doses of allergen are required. This may be due to much of the allergen is being broken down by saliva and other factors. On average, the DAILY dose of SLIT is about twice the MONTHLY dose of SCIT. One study using dust mite sublingually used 70 micrograms of allergen daily, whereas the effective injection dose is around 5-10 micrograms per month. If you look at a variety of studies, you see that the total dose of SLIT is about 30 to 200 times the total injection dose.

So, the result is that the cost of the allergen extract can become prohibitive if the patient is being treated for more than a few allergens. A very rough estimate would be that for year-round type allergens (dust mite, cat, for example), the cost would be $100 per allergen per month. Seasonal pollens would cost about $10-20 each per month.

 

So, if someone was allergic to dust mite, cat, and a few pollens pollens, the extract or “sublingual drops” would cost about $300 per month just to purchase the extract from the manufacturer (this is not even accounting for the administrative costs). So, it would get quite expensive. In addition, until a product is approved by the FDA, SLIT won’t likely be covered by insurance plans. That is, the entire cost would be out-of-pocket. If you look at Grazax, a sublingual tablet for grass pollen that is approved for use in Canada and Europe, it costs about $200 per month just to treat grass pollen allergy.

Although there are few studies that compare SLIT to SCIT, the general consensus is that SCIT is more effective. On average, SCIT (shots) studies show a 40% improvement in symptom scores, where SLIT (drops or tablets) improve symptoms by 20%. However, SLIT is appealing in that the patients can treat themselves mostly at home, and that no needles are involved. Plus, SLIT drops have been associated with less allergic reactions than SCIT shots.

In summary, the question is not whether sublingual allergen immunotherapy works (it apparently does), it is whether physicians are using adequate doses. For unclear reasons, allergic individuals in the US tend to be allergic to multiple allergens. This results in sublingual therapy being an expensive proposition.

 

I foresee that SLIT will have a place in certain situations (small children, patients allergic to one or two allergens). We are still in the process of deciding whether to begin using this method of allergy treatment. I would advise, however, that any potential patients ask their doctor about whether they are receiving an adequate dose of each allergen. Otherwise, that patient might be receiving a very expensive placebo.

 

Neil Gershman, MD

Vocal Cord Dysfunction or Paradoxical Vocal Cord Movement….. vocal fold motion, vocal cord dysfunction

Written on January 18, 2012 at 1:09 am, by Neil Gershman, MD

This is a very common problem which is very under appreciated. I will make a bold statement here. I believe most of the asthma ER visits in affluent areas (I’ll explain in a second) have as much to do with Vocal Cord Dysfunction (VCD) as the actual asthma.

What I mean is that if you are actually take your asthma medicines appropriately (using the inhalers correctly and as often as your doctor recommends), it is very unlikely that you end up in the ER with an asthma attack. The medicines are VERY effective these days. It’s people who can’t afford the medications or those who don’t get the proper medical advice (or won’t take or understand the advice) who end up in the ER for the most part.

So, if the asthma aren’t working, we think of VCD. I should mention that part of the recognition problem is that different medical professionals call this problem different things. I mentioned “VCD” to an ENT specialist, and he looked at me blankly. When we started talking about it, he said “oh yeah, that’s blah, blah, blah (I forgot what he called it!). So, you see the problem.

In any case, once it is recognized we can start to look for a solution. I find that most patients can learn to control it on there own with yoga and meditation breathing techniques. In more difficult cases, speech pathology therapists can help.

I found this nice video on youtube.com demonstrating the problem. I should warn you that it might be a little gross to some.

I am going to try and work with a  speech therapist to make a more comprehensive video.

Turning a nasal spray into a sinus irrigation

Written on January 16, 2012 at 3:28 pm, by Neil Gershman, MD

It’s essentially impossible to get topical medication into the sinuses. Here’s a video showing how to get the medicine from the nasal spray into the form of a sinus irrigation. Obviously, you must talk to your doctor before trying any new sinus or polyp treatment.

http://youtu.be/-kphDd3Xxco

Dr. Gershman Interview on NBC

Written on May 15, 2011 at 3:12 pm, by Neil Gershman, MD

Before the expo, Dr. Gershman went with some of the staff to NBC studios.

Dr. Gershman’s interview on NBC

Dr. Gershman discussing the importance of roach allergy

 

Michelle and Babie make a great support team