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Ketek Approved Based on Fraudulent Data

doi: 10.1097/01.EEM.0000296427.25393.b7

    Dr. Playe responds: I very much enjoyed Dr. Wyer's thoughtful response to my article on telithromycin and the dwindling supply of new antimicrobial agents. I agree with most everything that he said. I fully agree that the need for new antibiotics is in part due to “overmarketing by manufacturers to gullible practitioners of broad-spectrum agents for marginally important clinical indications.”

    I agree that the Ketek saga is one of fraud, dishonesty, and shame. To me the greatest shame is that a doctor would be willing to put patients at risk in exchange for personal monetary rewards. I've always said that a dishonest person cannot be allowed to practice medicine. Innocent patients will suffer. The propagation of “spin” that we tolerate in politicians and salespersons becomes similarly treacherous when they influence health care. This brings me to how I feel differently from Dr. Wyer.

    Much of this debacle (Dr. Wyer's nicely chosen word) and part of the reason there are not enough new antimicrobials (or, often, vaccine supplies) is because the profit motive drives much of U.S. health care. Profits are simply bigger for chronic medications. While the fraud in this case is despicable, the causes of the fiasco run deeper, and they persist.

    I believe the FDA is and, if pending legislation passes, will continue to be under-funded. A July 31, 2007, Boston Globe article stated, “The broader problem of the FDA is that reform legislation does not address is the enormous gap between its mission — ensuring the safety of drugs, medical devices, and most of the nation's domestic and imported food — and its annual budget of less than $2 billion.” The bills currently being considered ask for $225 million more from the pharmaceutical industry to fund safety studies. We're asking the fox to keep a closer eye on the hen house.

    Finally, while I agree that telithromycin (and many other antibiotics) should not be prescribed for minor illnesses, pneumonia and acute bacterial sinusitis are not minor. Sir William Osler referred to pneumonia as “The Captain of the Men of Death” in the pre-antibiotic era, and it still ranks as the leading infectious killer in the U.S. Acute bacterial sinusitis (as distinguished from the common cold with sinus pressure) can have lethal complications, and is, incidentally, still an approved indication for telithromycin in Europe.

    Dr. Wyer said my hypothetical patient with moderately severe pneumonia that could be from multiple-drug-resistant Streptococcus pneumoniae, and who has a reason not to take a beta-lactam antibiotic or a fluoroquinolone and has no indication of myasthenia gravis or hepatic disease “does not exist” because he “could not possibly be prospectively identified in the emergency department at presentation.” I disagree. We will not, of course, have culture results, but we might be concerned that it “could be from multiple-drug resistant S. pneumoniae” on the basis of co-morbidities, recent antibiotic treatment, or community- or residence-resistance patterns. These days, this would be a rare patient. If S. pneumoniae develops significant resistance to the respiratory quinolones, this scenario could be quite common. And this hypothetical patient does, after all, have a life-threatening illness.

    Section Description

    The authors are the principal investigators in the Olive View-UCLA Department of Emergency Medicine/Division of Infectious Diseases, and have been awarded a five-year, $9 million grant from the National Institutes of Health to study the use of off-patent antibiotics for treating uncomplicated skin and soft tissue infections. The study will be conducted at Olive View-UCLA, Johns Hopkins University, Maricopa Medical Center in Phoenix, Truman Medical Center and the University of Missouri in Kansas City, and Temple University Medical Center in Philadelphia.

    © 2007 Lippincott Williams & Wilkins, Inc.