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FAHF-2

History is Made at Lunch

By

By Henry Ehrlich

The outline for the next big step in the search for a cure for food allergy traveled from New York to Palo Alto in a purse.  I know because I saw it Tuesday when I joined Dr. Xiu-Min Li and Dr. Kari Nadeau at a restaurant near Mount Sinai at Madison Avenue and 98th St.  You’ve heard about Abraham Lincoln writing the Gettysburg Address on the back of an envelope?  The doctors outlined the structure for a major study of oral immunotherapy for food allergies (OIT) on a paper napkin.  As witness to this conversation (fly on the wall wouldn’t be fair to the restaurant) I had a glimpse of how science is conducted.  Far from being a highly technical or detached process, this was a lively conversation between women who clearly like one another and want to bring their intellectual and institutional resources to bear on behalf of people they care deeply about: food allergic people of all ages, particularly children.  “Chemistry” in this case describes far more than just what is measured back in the lab.

Dr. Kari Nadeau and Dr. Xiu-Min Li

Kari, you will recall, achieved mainstream prominence recently in the New York Times Magazine for her OIT research at Stanford.  Among the studies she has conducted are “rush” OIT, using anti-IgE drug omalizumab (Xolair) to reduce allergic reactions and allowing higher allergen dosing to expedite desensitization, and using Xolair to allow desensitization to multiple allergens.

Xiu-Min, who works with Dr. Hugh Sampson and the rest of the Jaffe Food Allergy Institute All Stars at Mount Sinai, is pioneering the use of traditional Chinese medicine (TCM) to treat allergic diseases including food allergies and asthma.  Her Food Allergy Herbal Formula-2 (FAHF-2) has reversed anaphylactic peanut-allergy in mice and is now in advanced human trials.  Dr. Li’s treatment differs from immunotherapy in that it modulates the immune system instead of in effect over-stimulating the production of allergen-specific IgE to the point of exhaustion, allowing non-allergic  IgG antibodies to take up all the space on mast cells and basophils.

The crux of the project they discussed Tuesday is to test FAHF-2 as an alternative to Xolair for rush OIT and for multi-allergy OIT.  This would be a tremendous advance because Xolair, while promising for these purposes, has some big drawbacks.  It is really expensive, is administered only by injection (sometimes producing serious reactions), and can be very painful.  It is currently used mainly for severe asthma and lately has attracted attention for helping with otherwise-untreatable chronic urticaria.  By contrast, FAHF-2 in its latest highly refined version can be taken as six pills a day and is proven safe.

Both ends of this collaboration have institutional capabilities that can be shared.  For example, Stanford has three staff members who specialize in the packaging of therapeutic doses of allergens for use in the trials.  Mount Sinai has the connections in China for ensuring uniform, high-quality FAHF-2.  Dr. Nadeau also mentioned that a great byproduct of the Times story is that she has received a huge volume of mail from patients asking for treatment, which comprises the basis of a larger research population than ever before, and which will be shared with collaborators at medical centers around the country.

After lunch we went back to the Annenberg Pavilion where Kari was to give a talk.  On the way, we chatted about the plight of patients and their families.  One thing she said really stood out.  After observing that OIT is nothing new conceptually, having been tried a century ago, and should be more advanced, she said, “Science never got ahead of patients’ needs.”

The talk itself was noteworthy for several reasons.  On a very superficial level, as one slide after another went up on the screen, with the authors of different studies listed under the data, as often as not three or four of them were actually sitting in the room.  This was a high-powered audience.

More important was the description of variables from all European and U.S. OIT studies thus far published that make desensitization to food so hard to achieve: up to 98% of participants in OIT studies overall will have allergic reactions during the course of the study, and up to 10% of these reactions occur during home dosing. Up to 4% of these reactions are severe and need epinephrine intramuscular injection. Up to 20% of subjects tested with abdominal complaints had positive results for eosinophils in the esophagus. Dr. Nadeau said investigators around the country and Europe aren’t sure whether the appearance of eosinophils during OIT represents a phase parallel to the spike in IgE that accompanies regular dosing, is a new disease induced by the treatment for another, or whether it is there all the time and is “unmasked” by the close attention patients are paying to their health during study. An estimated 20% drop out rate due to non-compliance or untoward side effects has been reported in U.S. and european OIT studies. One thing is sure: no single treatment is going to work for every patient.

All in all, not a bad way to spend a few hours.

Sally Noone of the Jaffe Food Allergy Institute at Mount Sinai Medical Center

By

By Kathy Franklin

Sally Noone

Sally Noone, RN, MSN, is one of the most respected professionals in the field of food allergy. She has worked in allergy research for 21 years, at Johns Hopkins and at Mount Sinai, and has co-authored 20 publications, including “Dietary baked milk accelerates the resolution of cow’s milk allergy in children,” “Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2),”  “Development and validation of educational materials for food allergy” and “Dietary baked egg accelerates resolution of egg allergy in children,” published this month in the Journal of Allergy and Clinical Immunology. The recipient of numerous awards, Sally was recently honored with the American Academy of Allergy, Asthma and Immunology’s Allied Professionals Recognition Award, and with her third Mount Sinai Medical Center Employee Recognition Service Award. Sally was kind enough to take some time out of her very busy schedule to speak with me about her work, her career, and the latest research news.

From Patients to Paperwork: Running a Clinical Trial
Sally Noone has served since 2005 as Clinical Research Manager at the Jaffe Food Allergy Institute. She is currently the Clinical Research Coordinator on two studies, Milk Oral Immunotherapy (OIT) plus Xolair® (omalizumab, anti-IgE) and Food Protein-Induced Enterocolitis Syndrome (FPIES).

What is a Clinical Research Coordinator? The CRC is the primary patient contact for a research study. She answers questions about the research from anyone interested in learning more, including parents, prospective volunteers, allergists, pediatricians, and even inquiring bloggers; she screens patients who wish to participate, seeing whether they qualify for a study; and she gives them all the information they need to decide whether a study is right for them. Sally encourages the patient to generate a list of research-related questions to ask their own physician, to help them better evaluate the potential risks and rewards of the treatment. Should someone decide to volunteer for the research, the CRC walks them through all the consent forms, and handles all scheduling. (As you can see, this job involves a lot of paperwork and a lot of phone calls!) When the patient begins a trial, the CRC is in charge, along with the study doctor, and spends a great deal of time with the patient, administering the treatment and monitoring their progress. Each visit generates a lot more paperwork. The CRC also keeps in contact with the patient between visits. She must keep track of all “adverse events” — everything from a cold to a rash to a sprained ankle must be recorded, monitored, and reported.

The Clinical Research Coordinator also is responsible for the annual submission to the IRB, the Institutional Review Board, which regulates and monitors all human research, ensuring that each study is safe, scientifically sound, and meets all ethical standards. The IRB requires that the doctors and nurses running the study are highly qualified, and ensures the risks to patients are minimized and the potential benefits are maximized. Every change in a study protocol, large or small, requires approval from the IRB. For example, reimbursement for transportation and free parking for study participants for Milk OIT has been added. They will cover local Metro North or Long Island Rail Road train costs, or transportation to and from a local airport. (Yes, people fly in from other cities to be part of this groundbreaking research, although airfare is not reimbursed.) Since that was not part of the original proposal, covering those costs required new IRB approval (and new paperwork for the CRC) before it could be instituted.

CRC Teamwork
In addition to her own two studies, Sally supervises all of the other CRCs at the Jaffe Food Allergy Institute, who are working on other ongoing allergy studies. The CRCs work very closely together, and each of them is qualified to work on any study, so if Sally has too many visits scheduled on the same day, another CRC can see one of her patients that day. They all share responsibilities for all the studies. If a CRC knows she will be away the next time the patient is scheduled, she will introduce the patient to the person who will be covering them.

Sally has always shared her time and knowledge with her colleagues and the community; she is a tireless advocate and educator. She recently gave three workshops/symposia at the annual AAAAI meeting, on GI Allergies, on Food Challenges, and on Patient Recruitment and Retention. This generosity and dedication has drawn high praise from professionals. Our contributor Anne F. Russell BSN, RN, AE-C Faculty, Spring Arbor University Department of Nursing says: “Sally has a wealth of food allergy clinical, educational and research experience. She has generously shared her abundant clinical expertise with me, and many others. She is not only a trailblazer in the field of food allergy science but also in the Profession of Nursing.”

Educating School Nurses
Sally also presents to school nurses at FAAN Conferences. “More than anything, school nurses need support. They know what to do medically in an emergency, but they need a lot of reassurance that they know what they know. It’s a tremendous responsibility, and they feel that responsibility. Sometimes they feel a lack of support, and feel that they have to rely on the families for their food allergy information.” Sally recommends three new web-based teaching initiatives as an important source of support for school nurses. FAAN & FAI have collaborated on a free, interactive online course available at http://allergyready.com. There is also a training module at http://www.allergyhome.org/schools. CoFAR, the Consortium of Food Allergy research, provides information online in their Food Allergy Education Program, at https://web.emmes.com/study/cofar/EducationProgram.htm. While the CoFAR teaching tools are primarily for parents, Sally recommends the site to school nurses as a good way for them to see what parents are learning.

A common complaint among school nurses is that parents of food-allergic students are obsessively concerned about their children’s health and safety. Nurse Sally makes a special point of explaining to them that these parents are not “hyper.” “For the most part, school nurses don’t see a serious allergic reaction. The ‘hyper’ mother has seen her child have a serious reaction. This isn’t ‘hyper’ anything, it’s appropriate behavior and it’s necessary.”

This concern for the feelings of parents is widely recognized by those who work with her.  Mary Jane Marchisotto, Executive Director of the Food Allergy Initiative says, “Sally has been a source of compassion and information about food allergies for thousands of families. She also plays a key role in educating health professionals and recruiting patients for important clinical trials. For all of us at FAI, it is a privilege to work with her and learn from her.”

While food allergy education and awareness have “gotten better,” Sally is still regularly invited to speak at schools, particularly at the beginning of the school year. She’s happy to oblige, but her busy schedule only allows her to speak in the evenings or late afternoons; other MSSM staff also will speak on food allergy at local schools whenever possible.

From Research to Therapies
Sally is excited by the current progress in research. “For the first time, we are starting to work on therapies. It seems to be within striking distance, that there might be something to offer other than strict avoidance. For example, the baked milk and baked egg studies have been amazing for people, many of whom can now safely eat milk and eggs.” [For those not familiar with these studies, researchers have found a way to introduce small amounts of well-baked milk or egg to highly-milk and egg-allergic patients, gradually increasing the doses – under strict medical supervision – until the patient is eating the foods, even unbaked, with no allergic reactions. Sally calls it “amazing”; several participants I have spoken with call it “life-changing.”]

What’s been the biggest surprise in conducting research? “I thought the shots [in the Milk Allergy Research with Xolair] would be the biggest turn-off for my patients, especially the younger ones. But after the first shot, it just wasn’t that big a deal to the kids. I have 7- and 8-year-old patients who don’t make any fuss about shots. I thought that would be a much bigger deal with the kids than it is.”

Another pleasant surprise for Sally is that “parents are our best recruiters and resources. Many parents have spontaneously offered to talk to other parents, explaining how the research experience was for them, sharing mealtime strategies, tips on how their children successfully managed to take their daily doses at sleep-away camp, and generally offering to be useful to other families participating in the study. That has been a huge positive.”

Does Sally have any allergies of her own?

“I don’t have any food allergies. I always thought I had a nickel allergy, because I can’t wear jewelry without getting a rash, but recently was tested by a dermatologist, and it turns out I’m allergic to gold, not nickel.” Her other allergy, ironic for an allergy researcher, is to hydrocortisone.

If there were more hours in the day, how would Sally use them? “See more patients, and make more phone calls to patients.”

Traditional Chinese Medicine and Allergy

By

by Dr. Xiu-Min Li

Dr. Xiu-Min Li

Allergic diseases are a significant health problem in “Westernized” countries. They represent a tremendous burden on quality of life for both patients and their families, and health care expenditures for the society as a whole. Food allergy in particular has no definitive treatment. The rise of allergic disease is prominently attributed to the “hygiene hypothesis” which contends that modern hygiene and other byproducts of modern behavior have deprived our immune systems of their natural enemies—mostly parasites–and our immune mechanisms have turned on normally harmless proteins in food, pollen, and so forth, instead. The accustomed medical approach is to control the response through medication and curtailing exposure. Certainly these are valid and important. But in the long run, my colleagues and I believe that the answer to this “Western” problem may be found in the “East.” That is the point of our “integrative” approach.

To be sure, allergic diseases are not only found in modern societies. They have been observed in some form throughout recorded history, including China, where I come from. And that is why I am working to bring what Chinese doctors have learned over the centuries into American medical practice. By combining these components of Traditional Chinese Medicine (TCM) into what we call integrative medicine, we hope to take advantage of the fact that the most powerful medical tool we have is the body itself. TCM is a unique system of theory, diagnosis and treatments including herbal medicines, acupuncture, mind-body therapy and dietary therapy. These are part of mainstream medicine not only in China and other Asian countries such as Korea and Japan, and are beginning to play a role in health care in the US and Europe.

At the Mount Sinai School of Medicine, we have taken a classical herbal formula called Wu-Mei-Wan that has been used in TCM for treating parasite infection and symptoms of food allergy-like conditions, and turned it into an herbal formula named food allergy herbal formula-2 (FAHF-2). We have shown that FAHF-2 can prevent and reverse established peanut allergy in animal-model peanut anaphylaxis, and that the effect is long lasting. There is nothing mysterious about this work, which is often the case with other so-called alternative treatments; our work is conducted according to NIH protocols and has been published in premier peer-reviewed journals. We measure and control and analyze, like any other Western researchers; everything must be repeatable. These data suggest that FAHF-2, and perhaps other Chinese herbal medicines may have a potential for treating food allergy. FAHF-2 is the first botanical drug that has entered clinical trials as an FDA Investigational New Drug (IND). Our phase I studies showed that FAHF-2 is safe and well tolerated. Phase II studies are in preparation at two centers–Mount Sinai, and Arkansas Children’s Hospital Research Institute in Little Rock.

We also developed anti-asthma herbal medicine international (ASHMI), which was shown in preclinical study to affect asthma mechanisms including inhibition of airway hyper-reactivity, inflammation and mucus hyperplasia, and overactive T-cell activity that can result in an allergic response. ASHMI is also effective in aged mice with asthma. Most exciting is that in addition to being safe and effective, ASHMI remained effective long after therapy. Unlike steroids, ASHMI does not induce overall suppression of immune system or adrenal function. This benefit is more than anything representative of the goal I mentioned earlier—to use the body’s own capabilities to fight disease. (I might add that this approach also has implications for the treatment of cancer and autoimmune diseases.)

Our studies provide scientific evidence supporting the use of TCM as a potential treatment for allergy and asthma. The goal of our clinical study is to develop botanical drugs that doctors can prescribe to complement or replace other therapies.

Food allergic children also suffer from other allergic conditions such as eczema, and environmental allergies. Families and physicians are interested in alternative approaches for these multiple allergic conditions. In addition to our research, and because acupuncture and herbal medicines are lawfully used by licensed practitioners in the US, we initiated an off-site TCM clinical program to help children with stubborn eczema associated with food allergies. The clinical outcomes have been well received. Given the growing interest in alternative and complementary medicine (CAM) therapies, and to make the clinical program accessible to more children, Mount Sinai Medical Center has established a new TCM clinical program named “Center for Integrative Medicine for Allergy and Immunology”. This center is supported by Winston-Wolkoff Children’s Holistic Medicine for Allergy Foundation and FARE.

This program will provide an additional health care option for children with multiple allergic conditions. This program will also provide allergists and pediatricians and dermatologists within or outside the Mt. Sinai with a reliable resource of CAM therapy. The combined effort will enhance the patient compliance and clinical outcomes.

Furthermore, we recently organized the first East-West Scientific Conference on Allergy and Traditional Medicine (EWAT) in China. This landmark conference—the first ever to focus on integrative medicine and allergy gathered some of the world leaders in allergy and traditional medicine research to share the most up-to date and comprehensive views on allergic diseases and traditional medicine as well as other new interventions for allergy. It not only provided an opportunity for experts to share knowledge of conventional allergy treatments, but also resulted in new insight into the growing use of traditional medicine and resulted in new collaborative research programs into traditional medicine as a potential solution to the allergy epidemic. Using this conference as a starting point, we continue to build up national and international collaborations to accelerate efforts to develop safe, effective natural products and novel therapies.

Dr. Xiu Min Li is Professor of Pediatrics in the Division of Pediatric Allergy and Immunology at Mount Sinai Hospital in New York. She has published her research in Journal of Allergy and Clinical Immunology and other top journals. She did her medical training at Stanford and Johns Hopkins, as well as Henen Medical University in China.

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