Deadly Staph germs may be cured by old, $1-a-day antibiotics
Thursday, 22 November 2007
Michael Janofsky
Generic, World War II-era antibiotics may become the newest weapon of choice in the fight against deadly, drug-resistant staph germs.
Physicians funded by the U.S. government are mounting two studies of drugs costing less than $1 a day to treat methicillin-resistant Staphylococcus aureus, known as MRSA. The bacteria, once found only in hospitals and nursing homes, are spreading to communal settings such as schools and gyms. Last month, MRSA was linked to the deaths of a student in New York and one in Virginia.
The generic antibiotics are used to treat infections before they require surgery. Drugmakers, meanwhile, are spending hundreds of millions developing medicines that cost more than $100 a day to treat advanced cases. More than 18,000 Americans annually are killed by MRSA, according to the U.S. Centers for Disease Control and Prevention in Atlanta.
``We have used these older drugs with success for years,'' says Gregory Moran, one of the study leaders. He is a professor of emergency medicine at the Olive View-UCLA Medical Center in Sylmar, California, affiliated with the University of California at Los Angeles.
``We know they kill bacteria in a petri dish, and we know they work in people,'' Moran says. ``What we don't have for them are clinical trials.''
The generics also have the advantage, at least for now, that bacteria haven't developed broad resistance to them, Moran says. The medicines can forestall complications that would require more expensive drugs, such as Wyeth's Tygacil, an antibiotic that won FDA approval in 2005 and costs about $100 a day. A typical daily dose of Pfizer Inc.'s Zyvox, a synthetic antibiotic used to treat MRSA, is two $60 pills daily for 10 to 14 days.
In August, the National Institutes of Health awarded $19 million to a research group led by Moran at UCLA and to another led by Dr. Henry Chambers III at the University of California at San Francisco. They aim to show that two families of older antibiotics -- sulfa drugs, in use since the 1930s, and clindamycin, first prescribed in the late 1970s -- should win Food and Drug Administration approval for MRSA.
Sulfa drugs are typically used for dysentery, urinary tract infections and a form of pneumonia. Clindamycin is used to fight infections and, in combination with other drugs, acne. The five- year studies are scheduled to start next year, with each including at least 1,200 emergency-room patients with skin or soft tissue infections, Moran says.
One of the groups received $8.6 million, Moran says. The hospitals are UCLA's Sylmar; Temple University Hospital in Philadelphia; the Truman Medical Centers in Kansas City, Missouri; Maricopa Medical Center in Phoenix; and Johns Hopkins Hospital in Baltimore
Chambers and his partners -- the Harbor-UCLA Medical Center in Torrance, California, and the University of Chicago Medical Center -- got $10.4 million.
The grants represent a realization by the NIH that there is a ``gap in the current knowledge'' about the older drugs and that government needs to step in when market conditions may discourage drug companies from filling it, Moran says.
``We know these drugs work,'' he says. ``They are already in wide use. But we want to confirm what doctors are doing, and the trials may change behavior somewhat.''
In 2005, 18,650 deaths were associated with MRSA, according to the most recent national study of the staph infections, in the Oct. 17 Journal of the American Medical Association. Of those, 13.7 percent came from community exposure and 85 percent were linked to patients in health-care settings.
Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH, says the grants were intended to fill a vacuum left by pharmaceutical companies. Drugmakers, he says, don't have an economic incentive to study drugs with expired patents or to develop antibiotics that have limited market potential.
Pharmaceutical companies typically generate most of their revenue and profit from drugs for chronic conditions such as the cholesterol pill Lipitor and the impotence medicine Viagra, both from New York-based Pfizer, the world's largest drugmaker.
``These are a temporary stopgap,'' Fauci says, referring to the generics. ``Sooner or later, the microbes will develop a resistance to them, and at the end of the day we'll need permanent solutions.''
Among drug companies seeking them are Pfizer; New Brunswick, New Jersey-based Johnson & Johnson and Indianapolis- based Eli Lilly & Co. The new antibiotics they are developing ultimately will be needed as staph bacteria mutate and become more resistant even to the sulfa drugs and clindamycin, Fauci says.
Bloomberg
Generic, World War II-era antibiotics may become the newest weapon of choice in the fight against deadly, drug-resistant staph germs.
Physicians funded by the U.S. government are mounting two studies of drugs costing less than $1 a day to treat methicillin-resistant Staphylococcus aureus, known as MRSA. The bacteria, once found only in hospitals and nursing homes, are spreading to communal settings such as schools and gyms. Last month, MRSA was linked to the deaths of a student in New York and one in Virginia.
The generic antibiotics are used to treat infections before they require surgery. Drugmakers, meanwhile, are spending hundreds of millions developing medicines that cost more than $100 a day to treat advanced cases. More than 18,000 Americans annually are killed by MRSA, according to the U.S. Centers for Disease Control and Prevention in Atlanta.
``We have used these older drugs with success for years,'' says Gregory Moran, one of the study leaders. He is a professor of emergency medicine at the Olive View-UCLA Medical Center in Sylmar, California, affiliated with the University of California at Los Angeles.
``We know they kill bacteria in a petri dish, and we know they work in people,'' Moran says. ``What we don't have for them are clinical trials.''
The generics also have the advantage, at least for now, that bacteria haven't developed broad resistance to them, Moran says. The medicines can forestall complications that would require more expensive drugs, such as Wyeth's Tygacil, an antibiotic that won FDA approval in 2005 and costs about $100 a day. A typical daily dose of Pfizer Inc.'s Zyvox, a synthetic antibiotic used to treat MRSA, is two $60 pills daily for 10 to 14 days.
In August, the National Institutes of Health awarded $19 million to a research group led by Moran at UCLA and to another led by Dr. Henry Chambers III at the University of California at San Francisco. They aim to show that two families of older antibiotics -- sulfa drugs, in use since the 1930s, and clindamycin, first prescribed in the late 1970s -- should win Food and Drug Administration approval for MRSA.
Sulfa drugs are typically used for dysentery, urinary tract infections and a form of pneumonia. Clindamycin is used to fight infections and, in combination with other drugs, acne. The five- year studies are scheduled to start next year, with each including at least 1,200 emergency-room patients with skin or soft tissue infections, Moran says.
One of the groups received $8.6 million, Moran says. The hospitals are UCLA's Sylmar; Temple University Hospital in Philadelphia; the Truman Medical Centers in Kansas City, Missouri; Maricopa Medical Center in Phoenix; and Johns Hopkins Hospital in Baltimore
Chambers and his partners -- the Harbor-UCLA Medical Center in Torrance, California, and the University of Chicago Medical Center -- got $10.4 million.
The grants represent a realization by the NIH that there is a ``gap in the current knowledge'' about the older drugs and that government needs to step in when market conditions may discourage drug companies from filling it, Moran says.
``We know these drugs work,'' he says. ``They are already in wide use. But we want to confirm what doctors are doing, and the trials may change behavior somewhat.''
In 2005, 18,650 deaths were associated with MRSA, according to the most recent national study of the staph infections, in the Oct. 17 Journal of the American Medical Association. Of those, 13.7 percent came from community exposure and 85 percent were linked to patients in health-care settings.
Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH, says the grants were intended to fill a vacuum left by pharmaceutical companies. Drugmakers, he says, don't have an economic incentive to study drugs with expired patents or to develop antibiotics that have limited market potential.
Pharmaceutical companies typically generate most of their revenue and profit from drugs for chronic conditions such as the cholesterol pill Lipitor and the impotence medicine Viagra, both from New York-based Pfizer, the world's largest drugmaker.
``These are a temporary stopgap,'' Fauci says, referring to the generics. ``Sooner or later, the microbes will develop a resistance to them, and at the end of the day we'll need permanent solutions.''
Among drug companies seeking them are Pfizer; New Brunswick, New Jersey-based Johnson & Johnson and Indianapolis- based Eli Lilly & Co. The new antibiotics they are developing ultimately will be needed as staph bacteria mutate and become more resistant even to the sulfa drugs and clindamycin, Fauci says.
Bloomberg