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FDA announces pending ban on ephedra.




Bad breath could be lung disease clue.

  
January 7, 2004
  
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“Yes,” said 82 percent of readers responding, the College should include workshops at the annual meeting about physician dissatisfaction, stress and burnout.

   

Poll 1
Should the FDA require all dietary supplements to undergo the same efficacy and safety standards as OTC and prescription medications?
Yes, it would prevent worthless and unsafe agents to be sold to the public.
No, it should be the individual, not the government, deciding which supplements we take.

view results

 
Poll 2
What percentage of your patients take herbal therapies?
0-25%
26-50%
51-75%
>75%
I don’t know because I don’t ask my patients.

view results

 
  
Calendar

January
Allergy and AEDS -- Adverse Reactions to Food Proteins
Jan. 22-24, Milan, Italy
Tel: +39 2 6363-3285
E-mail:
pedmell@genie.it
Link

 
• April

American College of Occupational and Environmental Medicine (ACOEM)
April 30-May 7, Kansas City, Mo.
Tel.: 847-818-1800, ext. 380 or 368
E-mail: dshah@acoem.org
 or mdreger@acoem.org
Link

 

 

 
  
Top Stories
 
FDA plans ephedra ban
The Food and Drug Administration recently announced a pending ban on ephedra, a dietary supplement linked to 155 deaths and numerous heart attacks and strokes. Federal paperwork requirements to ban the drug won’t be completed until March, and the stimulant will legally remain on the market until then. However, the FDA urged consumers to stop taking ephedra-containing supplements immediately and informed 62 companies that manufacture or market ephedra to stop selling the products as soon as possible.
    
Bad breath may signal lung disease
People with lung diseases have highly acidic breath, with severity of acidity relative to severity of their condition, according to a study in the European Respiratory Journal. Researchers at the University of Virginia asked 100 subjects to breathe into a disposable breathalyzer and provide four samples per day for one week. Scientists measured the pH levels, finding that they remained relatively stable and slightly alkaline in the patients who did not have lung diseases, but fluctuated while remaining acidic in those with lung diseases. When lung disease patients received proper treatment, researchers reported, their pH levels rose.
 
CDC tracks pediatric flu deaths
The Centers for Disease Control and Prevention are investigating eight recent Georgia children’s deaths as part of a nationwide assessment of the number of children under 18 who have died from influenza-related illnesses this season. Typically, flu cases and deaths are not tracked, as it is not among the infectious diseases recorded by state health departments. However, this year’s strain is especially dangerous for children, so the CDC has assigned a team to investigate pediatric flu cases and deaths. In addition, this year’s flu vaccine did not include the widely circulating strain A Fujian virus.
   
  

A word from President Michael Blaiss, M.D.

It’s About Time!
I had just finished writing a column for the New Year, stating that this time of year is slow for news that affects the allergy community and reviewing the upcoming events for 2004. I was about to send it to the Web masters for placement in the e-newsletter you now are reading when the news hit: Ephedra will be banned from use in the United States.

All I can say is that it’s about time. I’m sure you have had patients who use ephedra. It is primarily taken for weight loss and increased energy, but it is also marketed for use in the treatment of allergic rhinitis and asthma. It contains different alkaloids, including ephedrine and norephedrine, which are the basis for its use for the above conditions. You may also see it called by its Chinese name Ma Haung, as it is a Chinese herb taken from a shrub grown in Central Asia.

What’s the problem with ephedra? It has been linked to strokes, myocardial infarctions, and death. In 2000, a New England Journal of Medicine article reviewed 140 reports of adverse events associated with the use of ephedra. In fact, several high profile athletes’ deaths have been linked to ephedra. This “natural” supplement has already been banned by the NCAA, NFL, the U.S. Armed Services, and the International Olympic Committee, along with three states.

Why did it take so long for the FDA to ban this agent? If it had been a prescription medication, it would have been removed years ago. It goes back to the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under this law, a product (other than tobacco) taken by mouth that contains a “dietary ingredient” intended to supplement the diet is protected. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. “Dietary ingredients” are exempted from requirements of prescription and OTC medications by this law, and in fact, the FDA must show a “dietary ingredient” to be unsafe before it can be removed from the market.

I’m hopeful the public will realize with the banning of ephedra that just because a substance is “natural” doesn’t mean it is safe. As allergists, we work daily to educate our patients about the risks and benefits of each medication we prescribe. Unfortunately, more and more of our patients end up at the health food store because they believe “natural” treatments are safer and better. By better educating the general public about efficacy and safety of herbal products, we may be able to stem this tide.

I want to praise FDA Commissioner Mark McClellan, M.D., for taking this important step, but it must not stop there. We need to push further. You can still get the dietary supplement kava off the shelf. It is made from the dried root of the pepper plant and is used to treat anxiety. This herb has been linked to liver toxicity, extrapyamidal side effects, and dermapathy. Many European countries have banned this substance and it needs to be banned in the United States, too. The major problem is the Dietary Supplement Health and Education Act. We need to lobby our legislators to change this law and require the same standards of efficacy, safety, and purity for “dietary ingredients” as we do of our prescription and OTC medications. That is the only fair way to ensure the health of the American public.

Michael Blaiss, M.D.

    
Articles of Interest from the President
At times I come across an article or Web site that may be of interest to the allergy community. The January 1, 2004, issue of the New England Journal of Medicine had a fascinating article on “Dissatisfaction with Medical Practice" by Abigail Zuger, M.D. With the recent editorial on the subject, I found Dr. Zuger's comments enlightening. Check it out.
 
Regulatory Updates
 
Houston physician group settles antitrust charges
Houston physician group Memorial Hermann Health Network Providers recently settled federal antitrust charges arising from its use of the messenger model of dealing with health plans. The group agreed to quit exchanging information among physicians about:
• Individual doctor’s willingness to work with a health plan or payer
• Individual physician’s terms of working with a payer
• Collectively refusing to deal with a payer based on price or competitive terms
The agreement settles FTC charges that the group violated antitrust laws by price fixing during contract negotiation with managed care companies.
 
Association News
 

Annual Meeting captured on CD-ROM and now also on DVD
Plenary sessions from the 2003 ACAAI Annual Meeting are available for the first time on DVD as well as CD-ROM, made possible by an educational grant from Aventis Pharmaceuticals.

Both formats contain 16 hours of annual meeting presentations for both Macintosh and Windows platforms. The program includes copies of all slides, original presenters’ audio narration and interactive questions. As an accelerated learning activity, it offers 16 hours of CME credit.

• CD-ROM: The six-disc collection is available for $125 per set.

• DVD: The one-disc package is priced at $100.

Michael S. Blaiss, M.D., has served as medical editor since 1993, when the College became the first medical association to capture and distribute its Annual Meeting on CD-ROM.

The Annual Meeting CD-ROM set or DVD may be purchased through VioWorks. For ordering information visit: http://www.vioworks.com/clients/acaai2003/order.asp

Compliance training right at your desktop
Medicare excluded an average of 5.8 physicians per day between January and June 2003 because of fraudulent billing practices. The office of the Inspector General of CMS has essentially mandated that all physicians implement a compliance plan that will help to prevent this kind of outcome.

The JCAAI has developed a compliance plan specifically for allergists. It is Internet-based and available 24/7. It is more than a compliance plan, however; it is also a business plan. It has been developed in association with Karen Zupko and Associates, a practice management consulting firm. It is a plan not only for physicians, but as required by CMS, for all of your staff.

The price is far below the price of any other compliance plan. If you are a JCAAI member, your cost will be about $180 for a one-physician, five-employee office. If you are not a JCAAI member, the price will be $360, but that also entitles you a one-year JCAAI membership, so you can find out what you are missing. Watch for specific announcements, which will be emailed to you by the JCAAI.

2004 CME-initiative will help you streamline your practice
In a recent survey, 83 percent of allergists who participated in The Patient-Centered Allergy Practice, a CME Series in Practice  Management, said it improved their practices’ efficiency.

This complimentary CME series on allergy practice management is helping physicians across the country streamline their allergy practices and make their offices patient-centered. To register for the new 2004 program or for more advice from the series, call (800) 781-2211, ext. 100, or e-mail info@physicianspractice.com. Visit www.acaai.org for a copy of the series’ CME-accredited white paper.

All program materials are complimentary. The Patient-Centered Allergy Practice is sponsored by Professional Education Services Group, supported through an unrestricted educational grant from Aventis Pharmaceuticals and endorsed by the American College of Allergy, Asthma & Immunology.

 
Drugs and Devices
New asthma drug in early trials
Scientists are studying a new class of asthma drug that targets tachykinins, chemicals present in the nerves and some immune cells that have been linked to mucus secretion, inflammation, narrowing of airways and possibly coughing, according to a study in the European Respiratory Journal. Researchers in Belgium and the United Kingdom tested the drug, called DNK333, on 19 men with mild asthma, finding that it significantly reduced restriction in their lungs.
 
 
Fellows-in-Training
 
Prepared by Warner W. Carr, M.D., a representative of ACAAI’s fellows-in-training (FITs) to the Board of Regents, this department features two sections. Ask An Expert is an occasional feature with a specialist in the field answering a series of FIT-oriented questions on topics of interest to allergists in training. The Board Review Corner is your chance to test your Board preparedness by answering questions drawn from the College’s Board Review Course.

To refer to Board Review Corner and Ask the Expert questions from previous 2003 issues, click the “Archive” link in the left column.

Topic: Board Review Corner By Ernest N. Charlesworth, M.D.

Copyright © 2004 American College of Allergy, Asthma & Immunology. All rights reserved.

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