A new Generation of Superbugs - Aspergillus included on list

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New Front Developing in War on Killer Bugs By Diedtra , The Boston

Globe

Mar. 27--A Lexington company has successfully completed the first clinical

trial for a drug to combat a bacterium that ranks high on an infectious disease

group's " hit list " of killer bugs.

The bad bugs list compiled by the Infectious Diseases Society of America

includes six harmful microbes that are becoming more prevalent at a time when

there are a shrinking number of drugs to treat them effectively.

Cubist Pharmaceuticals says that its drug Cubicin, already used by doctors to

treat complicated skin infections, can be effective at combating Staphylococcus

aureus in the bloodstream. According to the Food and Drug Administration, S.

aureus is the second-most-common bacteria identified in hospitalized patients

whose blood becomes infected with bacteria. American hospitals spend $9.7

billion per year treating the resulting infections.

" The Cubist drug was tested in perhaps the toughest of all infections, " said

Dr. G. Bartlett, chief of infectious disease at s Hopkins. " The stakes

do not get any higher, not in infectious disease. "

To show Cubicin's effectiveness, the company had to pull off the unprecedented

feat of testing the drug against the S. aureus bacteria while it was coursing

through patients' bloodstreams.

The logistics of the trial were complicated: Potential trial participants had

bacterial infections that could -- but not always -- lead to the heart

complications the company also wanted to study. Cubist screened 5,000 patients

in 76 potential study sites in six countries. Older drugs now used to treat

bacteria-induced heart inflammation were studied in just a few patients.

Cubist's ensuing trial cost the company an estimated $100,000 per patient for

the 246 patients enrolled in the international trial, said Bartlett at s

Hopkins, who did not participate in the trial but has studied it closely.

Mike Bonney, Cubist's chief executive, said the company's " bold decision "

gives it a nearly four-year lead over its rivals.

" We persevered and got it done, " Bonney said. " I'm not convinced others will

do it. "

Cubists' upcoming reward: the FDA's first-ever approval of a drug to treat

Staphylococcus aureus bacteria in the bloodstream, which can lead to infective

endocarditis, an ailment that inflames and imperils hearts.

Late Friday, the company reported the FDA's conditional approval of expanded

use of its drug. Today, the company and the agency will continue finalizing the

wording of the drug's label, complicated negotiations that delayed full FDA

approval of the product.

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While Cubist estimates a market opportunity of up to $1 billion per year,

infectious disease experts say they really need three or four more Cubicins as

reserves to offer patients when it and other drugs stop working against S.

aureus.

Doctors say they lack effective treatments for many tenacious germs they see

daily in hospitals, drug-resistant microbes that can spread in the time it takes

drug firms to develop a new therapy.

" These bugs are small bugs. They become big bugs in five years. And it takes

eight years to develop a new drug, " said Bartlett, chairman of the Infectious

Diseases Society of America task force that's pushing for more and better

antimicrobial drugs.

At the top of their list: S. aureus, which has become resistant to the

antibiotic methicillin. That bacteria -- a common cause of a wound infection

after surgery -- is creeping into community settings, such as locker rooms. The

experts' wish list also includes additional remedies for Acinetobacter

baumannii, a bug that infects the wounds of soldiers returning from Iraq.

" We're worried about that because that is becoming more of a problem, "

Bartlett said. Plus, doctors don't know how it gets into soldiers' wounds. It

could happen after they're airlifted out of Iraq for medical care.

The bacteria commonly live on the body's surfaces and normally are kept in

check by the immune system, said Dr. Alice M. Mascette of the National Heart,

Lung and Blood Institute. Dispatched into the bloodstream through such means as

dental work and intravenous catheters, researchers believe the bacteria's sticky

surfaces help them latch onto opportune places. Think Velcro.

A minuscule abnormality in the heart valve may give the organism an ideal

place to " stick and grow, " said Mascette, director of the clinical and molecular

medicine program within the division of heart and vascular disease. Once

embedded, they're difficult to flush out. " Vegetations " -- clusters of organisms

-- act like a blood clot and can trigger a stroke.

In the heart, the bacteria hone in on valves and can compromise the body's

blood-pumping system. Endocarditis, an inflammation of the lining of the heart

and valves caused by the bacteria, can strike the heart's right or left side.

" Left-sided " endocarditis compromises the part of the heart that provides blood

to feed the entire body, she said.

" Endocarditis is what many of us feel is the mother of all infections, " said

Bartlett. " Without treatment, it's 100 percent fatal. Everybody dies. "

Cubists' $1 billion sales estimate is based on the 120,000 Americans who

suffer from S. aureus bacteremia annually.

For hospitals, an effective treatment for S. aureus in the blood could result

in substantial cost savings.

Patients who develop S. aureus bacteremia stay in the hospital 14.3 days on

average, compared with 4.5 days for patients who don't develop it. And their

care costs $48,000 versus $14,000 for a hospital stay uncomplicated by the

bacterial infection. The Staph infection increases hospital mortality rates to

11.2 percent, compared with 2.3 percent without it, Bartlett said.

Federal advisers whose votes guide FDA decisions unanimously agreed on March

6, 9-0, that the drug is safe and effective for use against S. aureus

bacteremia. The approval margin narrowed to 5-4 in deciding whether Cubicin is

safe and effective for treating infective endocarditis.

Dr. Townsend, a University of Virginia infectious disease expert,

voted no. He is unconvinced by data from the small number of patients in the

Cubicin trial who had infective endocarditis. Townsend is also alarmed that when

Cubicin failed to tamp down bacterial infection, some patients showed signs of

developing resistance to the drug.

" The Cubicin issue is, in some ways, a microcosm of what we're seeing in the

world of infectious diseases, " said Townsend, an associate professor in the

division of infectious diseases and international health.

" If Cubicin gets used more than it needs to, then we're going to see

increasing resistance to Cubicin, " he said. " It's now one of the last lines of

defense. Where do we go to from there? "

A NEW GENERATION OF SUPERBUGS

A " hit list " of drug-resistant microbes, released this month by the Infectious

Diseases Society of America:

--Methicillin-resistant Staphylococcus aureus, or MRSA: causes the majority of

healthcare associated infections.

--Escherichia coli and Klebsiella: cause many urinary tract, gastrointestinal

tract, and wound infections.

--Acinetobacter baumannii: increasingly cause of hospital-acquired pneumonia

with death rates up to 50 percent.

--Aspergillus: Especially of concern for people with weakened immune systems,

such as cancer patients, organ transplant recipients, people with HIV.

--Vancomycin-resistant Enterococcus faecium, or VRE: a major cause of

bloodstream infections, heart infections, meningitis, and intra-abdominal

infections.

--Pseudomonas aeruginosa: causes severe infection that can be

life-threatening.

-----

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Copyright © 2006, The Boston Globe

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CBST,

Source: The Boston Globe

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This S. Aureus bacteria was one found in these swine

operations.

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