IDSA Releases Hit List of Dangerous Bugs 'Congress Must Pass

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IDSA Releases Hit List of Dangerous Bugs; 'Congress Must Pass

Legislation to Avert Public Health Crisis,' Group Says

3/1/2006 9:00:00 AM

U.S. Newswire (press release) - Washington,DC

http://releases.usnewswire.com/GetRelease.asp?id=61637

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National Desk, Health Reporter

Contact: Steve Baragona of the Infectious Diseases Society of

America, 703-299-0412 or sbaragona@...

WASHINGTON, March 1 /U.S. Newswire/ -- The Infectious Diseases

Society of America (IDSA) today renewed its call for federal

legislation to galvanize the pharmaceutical and biotechnology

industries into fighting the growing epidemic of antimicrobial

resistance, releasing a " Hit List " of the six top-priority

dangerous, drug-resistant microbes. These six " superbugs " are

especially dangerous because few or no new drugs are being developed

to treat them.

The Hit List was drawn from an article in the March 1 issue of

Clinical Infectious Diseases.

" These are life-threatening drug-resistant infections, and we're

seeing them every day,' says IDSA President J. Blaser,

M.D. " What is worse is that our ammunition is running out and there

are no reinforcements in sight. "

Congress has not passed the comprehensive legislation needed to

stimulate antimicrobial research and development that IDSA called

for in its July 2004 report, " Bad Bugs, No Drugs: As Antibiotic

Discovery Stagnates ... A Public Health Crisis Brews.

The new article and Hit List, written by the authors of the " Bad

Bugs " report, re-focus attention on the issue by identifying what

experts in the field believe are " the microbes where the gap between

public health threat and drug development are the greatest, " says

G. Bartlett, M.D., chair of IDSA's Antimicrobial Availability

Task Force and one of authors of the article. " These are the germs

we see in hospitals every day that we don't have good treatments

for. "

" These organisms are a serious threat to public health, but it's

much more profitable for a pharmaceutical company to make a

cholesterol drug that you take for a lifetime than an antibiotic you

take for a week, " says H. Talbot, M.D., lead author of the

article. " IDSA is concerned that market forces are not going to

solve this problem, " he adds.

IDSA's " Bad Bugs, No Drugs " report showed a steady 20-year decline

in the number of new FDA-approved antimicrobials and total

withdrawal from the field by many major pharmaceutical companies.

The authors of the report revisited the issue and found a few more

drugs in the pipeline. " But the germs that are the biggest problems

are not the ones getting the most attention from the major

pharmaceutical companies, " Dr. Talbot says. " Action is needed -- and

soon, " he adds, " because it takes years for a new drug to go from

the lab to the medicine cabinet. "

IDSA is urging Congress to pass comprehensive legislation to

encourage the pharmaceutical industry to re-enter this essential

field. Congress should establish a commission to set antimicrobial

discovery priorities. Companies that develop novel antimicrobials

should be rewarded with market exclusivity rights. And research,

development, and manufacturing should be encouraged through tax

credits.

" Investments in stimulating antimicrobials research and development

will also pay dividends in other areas of infectious diseases

preparedness, including biodefense, " Dr. Bartlett notes. " It's

urgent that Congress make this investment now. "

THE HIT LIST:

-- Methicillin-resistant Staphylococcus aureus (MRSA): MRSA

infections constitute the majority of health care-associated

infections, increasing lengths of hospital stay, severity of

illness, deaths, and costs. While these infections used to be

limited primarily to hospitals, they are becoming increasingly

common in communities nationwide, especially where groups of people

are in close quarters, including military facilities, sports teams,

and prisons. The number of infected children jumped 28 percent

between 2001 and 2004.

Several treatment options are available for MRSA, but many have

harsh side effects, and resistance is growing to each of them. Most

of the drugs in development must be given by injection -- a painful,

inconvenient, and expensive route. Drugs that can be taken by mouth

are desperately needed.

-- Escherichia coli and Klebsiella species: These bacteria are major

causes of urinary tract, gastrointestinal tract, and wound

infections. They are becoming resistant to a growing number of

antibiotic classes at the same time as the frequency of outbreaks is

increasing. Failure to treat with the appropriate antibiotics during

a recently documented K. pneumoniae outbreak increased the mortality

rate from 14 percent to 64 percent.

Both microbes tend to rapidly evolve resistance to new drugs, but

few are available or under development. New therapies are badly

needed.

-- Acinetobacter baumannii: A. baumannii " is a prime example of a

mismatch between unmet medical need and the current antimicrobial

research and development pipeline, " according to the Clinical

Infectious Diseases article. The bacterium is a growing cause of

hospital-acquired pneumonia. Mortality rates range from 20 to 50

percent. The number and hardiness of drug- resistant strains are

growing. Soldiers are also returning from Iraq and Afghanistan with

cases of highly resistant Acinetobacter wound infections.

Doctors have been forced to resort to an old drug, colistin, which

had previously been abandoned as too toxic. But only one new drug is

on the horizon to treat Acinetobacter infections, and it is

considered to be too toxic for children.

-- Aspergillus: This fungal infection is a growing problem among

immunocompromised patients such as cancer patients, organ transplant

recipients, and people with HIV, and the number of infections is

expected to keep increasing as the number of immunocompromised

patients increases.

Existing drugs are toxic or interact with other drugs. Resistance to

them is growing. Even with the best, newly approved antifungals,

death rates from Aspergillus infection are 50 - 60 percent. Few new

antifungal drugs are in the pipeline, and their ability to combat

Aspergillus infections is uncertain because drug companies are

choosing to conduct clinical trials on other, easier-to-study fungal

infections.

-- Vancomycin-resistant Enterococcus faecium (VRE): VRE is a major

cause of bloodstream infections, infections of the heart,

meningitis, and intra-abdominal infections. A recent survey of 494

U.S. hospitals found a VRE rate of 10 percent of across all patient

groups. Rates are as high as 70 percent among high-risk groups.

While drugs are available to treat VRE, they have serious

shortcomings. Current drugs do not rapidly kill VRE, and only one is

available in an oral formulation.

-- Pseudomonas aeruginosa: This germ causes severe infection that

can be life-threatening, particularly in immunocompromised patients.

Rates of P. aeruginosa hospital-acquired pneumonia have nearly

doubled, from 9.6 percent in 1975 to 18.1 percent in 2003.

Infections following surgery and urinary tract infections from P.

aeruginosa have doubled. The germ poses a particular threat to

children with cystic fibrosis (CF). Antibiotics can keep CF patients

alive for decades, but eventually highly resistant germs take over.

With almost no alternatives left, these patients die unless they

receive lung transplants.

No novel drug candidates have entered human trials. New ideas,

research, and products are desperately needed.

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EDITOR'S NOTE: A virtual press kit, including high-resolution images

of the six organisms on the Hit List, fact sheets on antimicrobial

resistance and shrinking antimicrobial research and development, and

more can be found in the News Room on IDSA's Web site,

http://www.idsociety.org.

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IDSA is an organization of physicians, scientists, and other health

care professionals dedicated to promoting health through excellence

in infectious diseases research, education, prevention, and patient

care. The Society, which has nearly 8,000 members, was founded in

1963 and is based in andria, Va.

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