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Allergy-induced asthma in kids more likely in wealthier nations
Atopic sensitization and asthma symptoms among children increases with a country’s economic development, according to a study in the American Journal of Respiratory and Critical Care Medicine. Researchers from around the globe, led by researchers at Ulm University, Ulm, Germany, looked to assess differences in allergic sensitization and types of asthma experienced in various countries. The study involved nearly 55,000 children aged 8 to 12 years old from 22 countries representing a wide range of living conditions. In addition to parent questionnaires, 32,000 children received allergy skin tests, and another 8,951 received IgE blood tests. Overall, subjects with allergies in non-affluent countries were 2.2 times more likely than non-allergic subjects to have asthma. However, subjects with allergies from wealthier, more developed nations were four times more likely to have asthma than non-allergic subjects.

FDA launches Web tool to help consumers track drugs
The U.S. Food and Drug Administration (FDA) recently launched a Web-based tool to help consumers track their prescription and over-the-counter medicines and dietary supplements, as well as share this information with their health care professionals. Called “My Medicines Record,” the tool, available in Adobe PDF or Microsoft Word formats, can help consumers keep medicines straight and troubleshoot interactions.

Teenagers with jobs more likely to develop rhinitis
Teenagers with jobs have an increased risk of developing rhinitis, particularly if employed at high-risk jobs, according to a German study in the European Respiratory Journal. Scientists from the Institute for Occupational and Environmental Medicine in Munich looked at 3,795 subjects enrolled in a long-term asthma and allergies study. The subjects were 9 to 11 years old at enrollment and were re-contacted at 16 to 18 years old. Among them, 964 reported a work history. Of the working subjects, 37 percent reported developing allergic rhinitis for the first time, compared with 32 percent of subjects who had not been working. The risk was higher among subjects working in high-risk jobs, such as construction, nursing, and the metal and textile industries.

A message from ACAAI President Dr. Daniel Ein

We have seen, in the past few weeks, the release of two somewhat related documents that are of great importance to allergists and their patients. They are the full NHLBI Asthma Guidelines and the report of the Joint Task Force on Omalizumab. I am very proud of the role the College has played in the creation of each of these key reports.

The NHLBI Guidelines release was a national news event. There was coverage in major media, such as National Public Radio, The New York Times and, in my hometown, by the Washington Post. The College was mentioned in American Medical News.

It is a long document (440 pages) with an Executive Summary scheduled for December publication. I haven’t yet had a chance to read it all, but I have skimmed most of it and read closely a number of the sections that are of particular interest to me. The Guidelines are a well-written primer about asthma and encompass everything from causes to — of course — treatment. I have already recommended it to the students and residents who rotate through my clinic at George Washington Medical School.

I don’t intend to review it here. There will be many discussions and explanations of it in the months ahead, including at our Annual Meeting in Dallas.

What is highly striking, however, is the inclusion, for the first time, of the role of immunotherapy in the treatment of asthma. To quote the Guidelines (page 195),

“The Expert Panel recommends that allergen immunotherapy be considered for patients who have persistent asthma if evidence is clear of a relationship between symptoms and exposure to an allergen to which the patient is sensitive (Evidence B).”

This inclusion did not happen by itself and, in fact, did not appear in the draft version of the document that was circulated for comment earlier this year. The College, as you may remember, initiated a campaign to have you, our members, write the Expert Panel urging the addition of immunotherapy as a valuable treatment for allergic asthma. I am told, but have no independent verification, that hundreds of e-mails were sent.

The College Executive Committee also asked Drs. Ira Finegold and Linda S. Cox to prepare a formal report summarizing the data about the efficacy of allergen immunotherapy in this disease. They produced, in a very short time, a masterful summary of the data, which was submitted to the Expert Panel in the name of the College.

I cannot prove, but I strongly suspect, that these College initiatives finally allowed the deserved recognition of the treatment we have provided for nearly 100 years. We can all take pride in this accomplishment.

Drs. Cox and Finegold also co-chaired a Joint Task Force of the College and the AAAAI on Omalizumab to examine the cases of anaphylaxis that had been reported to the FDA and to make recommendations about appropriate waiting times after administration of the drug. The new black box warning about anaphylaxis attached to the drug is silent on waiting times and members have been asking for specific guidance on what to do in their practices and what to tell their patients. Interestingly and fortunately, the new NHLBI Guidelines also addresses this issue. The Task Force analyzed the data available to them and took into account the NHLBI guidelines. Their final recommendation reads,

“The Omalizumab Joint Task Force recommends that patients be kept under observation 30 minutes after the injection(s). This time should be extended for up to two hours for the first 3 injections based on the data reviewed by the OJTF as well as suggested in the 2007 National Heart, Lung and Blood Institute Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (NHLBI EPR-3, page 347). However, this could be modified based on a physician’s clinical judgment after discussing risks with the patient.”

Even if these were the only two accomplishments of the past year, I would leave this position feeling gratified that something worthwhile was achieved. We have a great team and a wonderful membership.

FDA accepting comments on proposed removal of “essential use” designation that allows use of CFCs in MDIs for epinephrine
In the Sept. 20, 2007, Federal Register, the Department of Health and Human Services (HHS) through the FDA announced a proposed change to its regulation on the use of chlorofluorocarbons (CFCs) in metered dose inhalers (MDIs) for epinephrine. The rule would remove the “essential-use” designation that allows the use of CFCs in these medications. For more information, see the FDA news release

The FDA proposes that any rule finalizing the removal of the essential use for OTC epinephrine MDIs have an effective date of Dec. 31, 2010. Should this rule become final, epinephrine MDI users will have to obtain a prescription for alternative drug products if a non-CFC epinephrine inhaler still does not exist.

The FDA will accept written or electronic comments on this proposed rule and data concerning technical barriers to developing an epinephrine inhaler without CFCs, the status of developing such a product, and the public health effects and costs of removing epinephrine MDIs from the market prior to a similar product being available OTC by Nov. 19, 2007. There will be a public meeting on the essential-use status of OTC MDIs containing epinephrine, which will provide an additional opportunity for public comment.

When submitting comments, please identify by Docket No. 2007N-0262 and/or RIN number 0910-AF92. Electronic comments can be sent to Federal eRulemaking Portal or the agency’s Web site. You also can send comments via facsimile to (301) 827-6870 or mail to Division of Dockets Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852.

All CFC-albuterol products are to be replaced by HFA products by no later than Dec. 31, 2008. The recommended ban for pirbuterol and other non-albuterol CFC products is Dec. 31, 2009

College to FDA: Removal of cromolyn sodium, pirbuterol
will put hardship on our patients
In its July 11 letter to the HHS through the FDA, the College requested that each asthma medication on the list for removal should be evaluated separately by the FDA because some of these medications are unique, and removal from the market will put a hardship on patients. The letter stated:

“One example on the list of a unique agent is cromolyn sodium. This agent is the only non-steroid inhaler for control of asthma in the U.S. Many of our patients prefer a non-steroid alternative for asthma control. It also is extremely effective for patients not able to tolerate albuterol in the prevention of exercise-induced bronchospasm. It also shows response in the prevention of asthma triggered by animals. Many of our patients would be impacted with poorer control of their asthma with removal of this medication prior to the development of an HFA formulation.

“Pirbuterol, a short-acting beta agonist, is unique due to its device. It is the only rescue medication for asthma in a breath-actuated device available in the U.S. Some of our patients are not able to use a regular metered-dose inhaler as they can’t coordinate actuating and breathing. This device allows them to receive optimal dosage of the rescue medication without worrying about using the device correctly. In a life-threatening asthma attack, this could make a great difference.

“We, the American College of Allergy, Asthma and Immunology believe that each asthma medication on the list for removal should be evaluated separately by the FDA. As mentioned above, some of these medications are unique and removal from the market will put a hardship on our patients. These agents should be continued to be produced and available by a prescription until their HFA formulations are developed and approved for use by the FDA.”

Learn how to integrate the NAEPP asthma
guidelines into your practice at the ACAAI Annual Meeting
The ACAAI Annual Meeting in Dallas, Nov. 8-14, offers scientific programs on the new NAEPP asthma guidelines and how to implement them into your current practice.

On Sunday, Nov. 11, the symposium titled “Implementing Key Concepts from the 2007 NHLBI/NAEPP Guidelines for the Diagnosis and Manage of Asthma” will include the following discussions:

• Therapeutic Interventions for Asthma: Rationale for Guideline Recommendations
— Dr. H. William Kelly

• Management of Asthma Exacerbations: ED and Hospital-Based Care
— Dr. Carlos A. Camargo

• Impact of the Environment and Co-Morbid Conditions on Asthma Management: Guideline Considerations
— Dr. Harold S. Nelson

• Periodic and Long-Term Management: Practical Applications of the Guidelines
— Dr. Michael B. Foggs

Faculty will discuss the major changes in the pharmacotherapy recommendations for persistent asthma, including the rationale for the recommendation of omalizumab and for giving equal weight to increasing the dose of inhaled corticosteroid or adding LABA in Step 3 therapy. They also will explain the rationale for dividing pediatric asthma into two age groups, discuss the data supporting volatile organic compounds and acetaminophen as risk factors for development of asthma, and explain the relationship between obesity and asthma. More important, they will describe where immunotherapy fits in the new guidelines, as well as the issues regarding its positioning.

Also on Sunday, Nov. 11, you will learn about the new asthma treatment guidelines in a new innovative, case-based interactive symposium that provides cutting-edge medical education in a peer-to-peer discussion format. The engaging program, “Practitioner’s Edge: The New Asthma Treatment Guidelines — Application in Clinical Practice” will link discussion of the latest scientific data with its application in the clinical setting. Panelists include Drs. Lawrence M. DuBuske, Bobby Q. Lanier, Gary S. Rachelefsky and Myron J. Zitt.

Online registration for the ACAAI Annual Meeting is fast and easy. You also can view the preliminary program online and select from a variety of Workshops and Meet the Professor Breakfasts tailored to your needs.

Remember to purchase tickets for the Annual Meeting Fundraising Dinner and performance by world-renowned vocalist and entertainer Wynonna Judd on Sunday evening, Nov. 11, benefiting the Foundation. The event is supported in part by grants from Alcon Laboratories Inc., AstraZeneca LP, Sepracor Inc., and Teva Specialty Pharmaceuticals.

Anthony S. Fauci receives Lasker Award for Public Service
Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), has been awarded the 2007 Mary Woodard Lasker Award for Public Service for his role in developing two major U.S. public health programs, in AIDS and biodefense. The award will be presented on Friday, Sept. 28, during a luncheon ceremony in New York City.

Dr. Fauci is honored for his role in helping develop the President's Emergency Plan for AIDS Relief (PEPFAR), the largest public health program in history devoted to a single disease, as well as Project Bioshield, designed to accelerate the research, development, purchase, and availability of medical countermeasures against the effects of biological, chemical, radiological, and nuclear agents.

His tenure as NIAID director began in 1984. For nearly 23 years, he has overseen the extensive NIAID research portfolio of basic and applied research to prevent, diagnose, and treat infectious and immunologic diseases.

“It is a remarkable privilege as a physician/scientist to be given the opportunity to help formulate policies and programs that protect and improve global health,” said Dr. Fauci. “I am fortunate to have been in a position to help bridge the gap between the biomedical research and policy-making communities, and to assist our leaders in developing programs predicated on the scientific advances made by NIH, our sister agencies within the Department of Health and Human Services, and our many collaborators worldwide.”

The Lasker Awards were first presented in 1946, and are administered by the Albert and Mary Lasker Foundation. The late Mary Woodard Lasker is widely recognized for her singular contribution to the growth of the NIH and her unflagging commitment to government funding of medical research in the hope of curing diseases. Her support for medical research spanned five decades, during which she was the nation’s foremost citizen-activist on behalf of medical science.

American Partnership for Eosinophilic Disorders
research grant applications due Nov. 1
The American Partnership for Eosinophilic Disorders (APFED), a non-profit advocacy organization for those living with eosinophilic esophagitis, eosinophilic gastroenteritis, eosinophilic colitis, hypereosinophilic syndrome, and other eosinophilic disorders — has developed the only named, peer-reviewed award for eosinophilic disorders. The $25,000 one-time annual grant is specifically dedicated to young investigators to support the development of an academic research career and support eosinophil-related research projects. More information and the actual application may be found on the APFED Web site.

Welcome to the AMA Corner prepared by Dr. Alnoor A. Malick, ACAAI Delegate to the AMA House of Delegates, to keep you abreast of important AMA news and developments impacting allergy-immunology.

Campaign to prevent Medicare pay cuts visits Washington state
As part of the AMA National House Call campaign, leaders from the AMA and the Washington State Medical Association (WSMA) are drawing public attention to the need for Congress to stop impending reductions in Medicare physician payments.

View www.ama-assn.org/ama/pub/category/17979.html to read more about the Sept. 18 House Call.

Under current law, Medicare will cut payments to physicians about 40 percent over the next nine years, even as physicians’ practice costs increase 20 percent. Over that period, Washington state stands to lose almost $4 billion for medical care for Medicare patients. An AMA Member Connect® Survey showed that 60 percent of physicians say they will be forced to limit the number of new Medicare patients they can treat if the first payment reduction, a 10-percent cut to take effect Jan. 1, 2008, is imposed.

File BCBS claim forms by Oct. 19 —
physicians collect more than $131 million
The AMA urges physicians eligible for Blue Cross Blue Shield (BCBS) settlements to file a completed claim form by Oct. 19. Physicians who provided covered services to any patient enrolled in or covered by BCBS plans at any time between May 22, 1999, and May 31, 2007, may be entitled to a payout as part of a class action lawsuit settlement agreement.

Visit www.ama-assn.org/ama/pub/category/17555.html to access an interactive map that displays which BCBS plans and subsidiaries have settled, and those that have not. View www.hmosettlements.com to download the BCBS claim form and claim form instructions.

AMA Foundation offers new resource to help improve patient safety
The AMA Foundation released a new patient safety monograph, “Reducing the Risk by Designing a Safer, Shame-free Healthcare Environment,” which can be purchased online. This 68-page monograph offers new supporting research, and explores how ineffective communication and low health literacy combine to affect patient safety. It also provides tools to decrease communication-related adverse events at a system-wide level and helps physicians initiate changes toward a safer and shame-free practice environment. As a bonus, one Safe Communication Universal Precautions tip card is included. The card serves as a take-away reminder of the tips featured within the monograph. Also included is continuing medical education credit for physicians.

Visit www.ama-assn.org/ama/pub/category/17114.html to learn more and order a patient safety monograph for $15.

Board Review Corner
Welcome to the Board Review Corner prepared by Soo Kim-Delio, M.D., Senior Representative of ACAAI’s fellows-in-training (FITs) to the Board of Regents. The Board Review Corner is your chance to test your Board preparedness.

To refer to a previous Board Review Corner, click the “FIT Archive” link in the left column.

Review Questions:Chapter 10 of Pediatric Allergy: Principles & Practices, edited by Donald Y.M. Leung, et al. Review questions were written by Drs. Bret Haymore and Soo Hee Kim-Delio, Walter Reed Army Medical Center

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Do you have news, responses or opinions to share with us? Please e-mail the association office at enews@acaai.org