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Health & Medicine
Vital Signs

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Vital Signs: Anthrax in the News
New Vaccine, Free Antibiotics? ... and more

With anthrax in the news these days, it seemed like a good idea to provide some info on anthrax that might not be the stuff making the headlines.  ...  

  • New Anthrax Vaccine Being Developed.
    Questions have been raised over the safety of current anthrax vaccines.  But that concern may become an historical footnote.  According to a Reuters' Health release earlier this month, a new human anthrax vaccine being developed in India is ready to go to clinical trials.
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    The new vaccine  was developed over the last 7 years with a grant of $250,000 from the Government of India's Department of Biotechnology (DBT) to the Center for Biotechnology (CBT) at the Jawaharlal Nehru University in New Delhi.  According to Dr. Rakesh Bhatnagar, chairman of the CBT, the team genetically engineered Escherichia coli to produce harmless mutations of the three key proteins -- the lethal factor, the edema factor and the protective antigen -- found in the bacteria responsible for anthrax, Bacillus anthracis .  "We have so optimized this technology that 30% of the protein that is expressed from the recombined E. coli genome is the protective antigen of anthrax, whereas its expression has been negligible in the past," Dr. Bhatnagar said.
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    "This work is very important for India," said Dr. V. K. Vinayak, an advisor at India's Department of Biotechnology (DBT).  "Not just in the current world scenario, but also because anthrax has always been a common problem in the country."  In addition, he said, the vaccine currently in use "is not intended for the general public, and is only meant for special groups, such as the [armed] forces." 
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  • U.S. Drug Makers Promise Free Antibiotics
    After a rash of bad publicity and threats to suspend its patent because of the national emergency, German drug-maker Bayer AG agreed to sell its now-famous Cipro for 95¢ a tablet, still a far cry from free.  But on the heels of that decision, U.S. drug-makers met with Homeland Security Director Tom Ridge and, according to Reuters Health, promised to "provide the government with free drugs and scientific experts to help keep its pledge to stockpile enough supplies for every American."
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    That promise would provide the government with access to seven additional antibiotics believed to be effective treatments for anthrax, including two in the same class as Cipro -- Bristol-Myers Squibb's Tequin (gaitfloxacin) and Johnson & Johnson's Levaquin (levofloxacin).  At this point, neither has been approved for the treatment of anthrax.  But both companies assured the government a supply of as many as 100 million tablets each if the FDA allowed them to include an indication for the treatment of anthrax on their labels, pending outcomes of laboratory tests.  Of course, with the usually long regimen associated with these drugs, 100 million tablets would only be enough for 4-8 million people.
    .
    Both of the drugs are extremely expensive:  Levaquin currently sells at about $8 per tablet wholesale, while Tequin sells for about $6.82 per tablet wholesale.  In addition, ten vaccine makers have also promised to supply the government with enough smallpox vaccine for every American by the end of next year, although details of that plan have yet to be worked out.
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  • CDC offers physicians guidelines for diagnosing inhalation anthrax
    On November 1st, a panel of experts from the Centers for Disease Control, which included Surgeon General Dr. David Satcher, held a telephone briefing on how office-based physicians should diagnose and treat inhalation anthrax.  Dr. Virginia Caine, who is with the Division of Infectious Diseases at the Indiana University School of Medicine, stressed the importance of early diagnosis for inhalational anthrax, since the time from the onset of symptoms to death can be as little as 3 days.
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    "The early signs are very similar to influenza," she said.  But there are a few key signs that can help to distinguish it.  These include "a wide mediastinum, lymphadenopathy, and pleural effusion."   Dr. Caine also noted that rhinitis may often not be present.  In addition, the white blood cell count -- usually a fairly reliable indicator of significant bacterial infection -- may not necessarily be elevated.  She also noted that not all patients will present with a fever.  A common course of the disease does mimic flu-like symptoms initially, after which patients will feel better, but then enter a second phase, characterized by shortness of breath and chest tightness.  "About 50% complain of acute abdominal pain and 5% have a usually fatal hemorrhagic meningitis," Dr. Caine said.
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    According to a CDC report, a physician who suspects inhalational anthrax should determine whether the patient has had 2 to 5 days of flu-like symptoms, and, if so, obtain a white blood cell count, chest x-ray, and blood cultures.  If the x-ray is abnormal, computerized tomography should also be used.  If the results on any of these tests are abnormal, or if the patient is moderately to severely ill, a prophylactic regimen of antibiotics is recommended.  For mildly ill patients, the recommendation was for close observation for the development of any new symptoms, and at least consideration of a prophylactic regimen of antibiotics.  Dr. Caine's stressed, however, that if suspicions arise that a patient does have anthrax, "go ahead and treat -- don't wait."  
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    The Surgeon general noted that "The CDC has a stockpile of antibiotics and very well-trained epidemiologists all over the U.S. to respond to this problem.  But," he added.  "We are dependent on physicians to identify early cases of anthrax."

NOTES: 
mediastinum
;  The space in the thoracic cavity behind the sternum and in between the two pleural sacs, containing the lungs.
lymphadenopathy; Swelling of the lymph nodes.
pleural effusion; A collection of fluid or blood in the pleural space, i.e., the chest cavity around the lungs.
rhinitis; inflammation of the mucous membrane of the nose.

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