BioWorld Today Washington Editor
Simply keepings hands washed, ensuring cuts and scrapes are kept clean and covered and avoiding sharing personal items, such as towels or razors, is the strongest defense against dangerous community-acquired staph infections, witnesses told lawmakers Wednesday at a congressional hearing.
The House Committee on Oversight and Government Reform convened the hearing in response to a recent surge in the number of reported cases of drug-resistant infections known as methicillin-resistant Staphylococcus aureus, or MRSA.
The Centers for Disease Control and Prevention last month reported that MRSA caused more than 94,000 life-threatening infections and nearly 19,000 deaths in the U.S. in 2005.
"That's far more deaths than previously believed. In fact, it is more deaths each year than caused by AIDS," said Committee Chairman Rep. Henry Waxman (D-Calif.). However, he noted that the annual number of U.S. deaths from influenza is about double the amount of those caused by MRSA.
While most of the 94,000 MRSA-related infections were associated with health care settings, more than 14 percent were community acquired, CDC Director Julie Gerberding told lawmakers.
MRSA has been around for decades, she said, calling the superbug the "cockroach of bacteria." But, she testified, CDC's recent report along with the recent deaths of two otherwise healthy school-age children in Virginia and New York plunged MRSA into the public spotlight.
S. aureus is commonly carried on the skin or in the nasal passages of about 30 percent of healthy people in the U.S., Gerberding explained. While the bacteria is one of the most common causes of skin infections, most S. aureus infections are minor, such as boils and simple abscesses, which can be treated by lancing the wound and draining the infection or through the use of orally administered antibiotics, she noted.
But, Gerberding cautioned, S. aureus also can cause serious infections, including surgical wound and bloodstream infections, endocarditis, toxic shock syndrome and pneumonia.
More than 90 percent of S. aureus isolates are resistant to penicillin and a large percentage are resistant to other antimicrobials including macrolides, lincosamides, tetracyclines or other antistaphylococcal agents, she said.
Methicillin and other semi-synthetic beta-lactam drugs were developed in the late 1950s to treat penicillin-resistant strains of S. aureus, yet strains resistant to those drugs emerged very quickly, Gerberding noted.
By the 1980s, MRSA strains were identified in hospitals with increasing frequency, often becoming resistant to multiple antimicrobial agents, she said. Community-acquired MRSA first emerged in the U.S. in Detroit in the early 1980s among intravenous drug users, Gerberding explained.
CDC in 2000 began investigating outbreaks of staphylococcal infections among inmates at prisons in Mississippi, Georgia and Texas, which she said, were later identified as being caused by the same strain of MRSA.
That strain, called USA300, is the potent form of MRSA now spreading in the community setting, Gerberding said. The USA300 strain has been found to cause infections in professional football players, military recruits in boot camp, children in daycare and in crystal methamphetamine users, she noted.
Rep. Tom Davis (R-Va.) said that at least 20 cases of community-acquired MRSA have recently been reported in his Northern Virginia district of Prince William County. He noted that MRSA currently is not included on the list of nationally reportable diseases and less than half of the nation's health departments have requirements in place for reporting the infection.
"When it comes to assigning blame for the spread of MRSA infections, almost no one comes to the argument with clean hands," Davis charged.
Overuse of antibiotics and spotty environmental sanitation at health care facilities allow the superbugs to simply "walk out the door" and into the community, he argued.
Gerberding responded that CDC has been working with hospitals and public health departments to curb the spread of MRSA in health care facilities and is focusing more effort on educating the public about how to prevent and control the infection in the community.
She challenged the biologic and pharmaceutical industries to focus more effort on developing novel approaches to combating drug-resistant infections.
The antibiotic pipeline has been "attenuated for a lot of reasons," Gerberding explained, noting that the drugs have a "shorter and shorter lifespan" because of growing resistance. Therefore, she lamented, firms have little incentive to develop the products.
In addition, Gerberding noted, few antibiotics are ever financial blockbusters for companies. The greatest hope for overcoming MRSA, Gerberding said, lies in the development of a vaccine. "If we can develop a vaccine," she said, "we will really save lives." But, Gerberding declared, it will take a "concerted and aggressive effort" from the drug industry.
Feds Settle With Cephalon
Cephalon agreed to pay $425 million to settle fraud charges brought by the U.S. Attorney's Office in Philadelphia related to Medicaid claims. The firm also agreed to a misdemeanor charge of violating the U.S. Food, Drug and Cosmetic Act related to marketing its narcolepsy drug Provigil (modafinil) for unapproved off-label indications.
The FDA in a February 2007 warning letter scolded Cephalon for distributing a promotional piece at a meeting of medical professionals that included false and misleading statements that Provigil was safe and effective for treating insomnia and fatigue associated with multiple sclerosis, Parkinson's disease, chronic fatigue syndrome, fibromyalgia, chronic pain, depression and attention-deficit/hyperactivity disorder, which are unapproved indications.
The promotional materials distributed at the meeting also failed to reveal details about risks associated with Provigil, the FDA said.
Cephalon agreed to enter into a corporate integrity agreement with the Department of Health and Human Services Office of Inspector General. The terms of the settlement are subject to the final negotiation and execution of definitive agreements, Cephalon said in a statement. The Frazer, Pa.-based company noted that a previously disclosed investigation by the Connecticut attorney general is ongoing.
"We look forward to finalizing our settlement with the U.S. Attorney's office," stated Cephalon CEO Frank Baldino Jr. "We have always taken seriously our responsibility to conduct our business in accordance with both the letter and spirit of the law. Over the past few years, we have devoted substantial resources to continually enhancing our compliance program and have built a strong foundation for our ongoing compliance efforts."