Mike the Mad Biologist

Well, we do it for narcotics. From Yahoo News:

International experts debated whether antibiotics merit a separate regulatory drug category at a World Congress held on December 11 and 12 at the Hyatt Regency Boston Hotel. “We proposed this drastic action because antibiotic resistance is undermining infectious disease treatment worldwide and many large pharmaceutical companies are leaving the antibiotic field,” explains Stuart B. Levy, MD, a Tufts Medical School professor and president of APUA, the global public health organization convening the meeting. Pharmaceutical companies spend an estimated $800 million to bring a new antibiotic to market. They face time limits on patent protection before others can manufacture and sell the compound without investing in this expensive research. Also pharmaceutical houses are turning to more profitable lifestyle and chronic disease drugs…

“If antibiotics can be given a special category by the U.S. Food and Drug Administration, then unique considerations could be applied to them,” says Levy. “By placing antibiotics in a separate regulatory category we could also promote better antibiotic stewardship by patients and doctors and promote responsible industry marketing strategies,” according to Kathy Young, executive director of APUA.

Antibiotics are powerful life-saving medicines for use in serious bacterial infections as diagnosed by a physician. However, casual antibiotic use is the norm in many hospitals and community practices in the U.S. As a result, we are experiencing accelerated evolution of resistant bacteria and increased difficulty of treating infections. According to the CDC, half of medically prescribed antibiotics in the U.S. are unnecessary.

Unlike most drugs, how one patient uses antibiotics can alter how well antibiotics will work in another patient. In other words, if you misuse vancomycin, bacteria can evolve resistance to it, but you misuse Lipitor all you want and it won’t effect someone else’s outcome. We need something, particular since CDC isn’t stepping up to the plate by proposing substantial policies like ‘search and destroy‘.

An aside: The cost to market of an antibiotic is not $800 million. It is $1.2 billion, once things like capitalization are accounted for.

Comments

  1. #1 Tony P
    December 17, 2006

    This is why I cannot get antibiotics for an ear infection. This is one that has been driving me nuts for months and it started responding to a ten day course of amoxicillin.

    But my damned ENT has had me on Maxxide, Ativan, Medrol, Prednisone, etc. No antibiotics. But I bet the ear infection would clear up.

    It isn’t my fault doctors passed out antibiotics like candy back in the day. Nor is it my fault that some still do. But when I need the stuff, the so called professionals are aghast to even recommend it.

    Makes me crazy.

  2. #2 Roy
    December 17, 2006

    In hospitals, doctors, nurses, and staffers, at the first sign of respiratory symptoms, get dosed with the latest and greatest antibiotics so that they won’t have to take off sick days. Even if the drugs don’t stop the infection, they may protect against catching a second infection, and symptomatic treatment will help keep down the sniffles, sneezing, and coughing.

    Actually, this is understandable. To recover completely from a cold, figure 10 workdays absence. On average, four colds a year means the budget needs to be 40 sick days a year. That’s eight weeks paid time off. Nobody (outside of Congress) can take 40 sick days a year. Thus people who work in hospitals must avoid taking sick time (just like the rest of the working world).

    Everybody with any connection to hospitals knows all this. All cops, paramedics, firefighters, and EMTs have their contacts at hospitals to get them the latest and greatest antibiotics.

    All these people are walking Petri dishes for nosocomial infections.

    If somebody wants to make any headway against resistant infections, they will have to give daily drug testing — for antibiotics — for all hospital personnel and all people visiting staffers.

  3. #3 llewelly
    December 17, 2006

    If somebody wants to make any headway against resistant infections, they will have to give daily drug testing — for antibiotics — for all hospital personnel and all people visiting staffers.

    But the root of the problem, as you describe it, is insufficient time off for illness. If insufficient time off for illness is the cause, drug testing will not fix it. There are too many ways around drug testing.

  4. #4 DAS
    December 17, 2006

    But the root of the problem, as you describe it, is insufficient time off for illness. – llewelly

    Indeed. Even a minor bacterial infection sometimes can resolve itself just fine if the patient has a chance to get proper bed-rest and plenty of fluids, etc. After all, people survive viral illnesses of comparable severity without anti-virals.

    But does anybody even know what the myriad federal, state and local regulations allow/require in terms of even unpayed sick leave? I have a friend who works as a gate-guard in that capitol of gated communities, South FL. She has ovarian cysts, and her employer has threatened to fire her if she even misses work for doctors’ appointments (and they don’t necessarily allow her to schedule time off in the first place).

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