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    A Common Synthetic Antibiotic Can Cause Permanent Side Effects


    Excerpt

    Anesthesiologist Todd Plumb was prescribed Levaquin in 2006. His symptoms included skin burning, profound insomnia and agitation, elevated liver enzymes and numerous issues with his gastrointestinal tract as well as severe numbness and burning pain in his extremities. He described the full onset and progression of neuropathy as similar to what cancer patients experience when going through chemotherapy.

    Plumb, who had never heard of fluoroquinolone poisoning during his years as an emergency room doctor and anesthesiologist, went to 15 doctors and spent a week in the Mayo Clinic, attempting to find a diagnosis. He also learned about fluoroquinolone poisoning online.

    "You'll see the same story repeated over and over again," he said. "Joint and tendon pain. Tendon rupture. Severe extremity pain. And no one believes them."

    The disbelief, according to Plumb, is due in part to the structure of the health care system, as doctors are taught to have faith in the medicines they prescribe their patients.

    "It's like losing faith in your religion," Plumb said. "I was in their camp before it happened to me. I'd had several people complain to me about problems with Cipro. I thought it was a safe medication that worked pretty well. I didn't want to feel myself that I was doing harm to patients."

    Plumb attributes some of this attitude to studies that are published in medical journals, saying almost every study of a drug shows a beneficial outcome.

    "The FDA doesn't do the research on the drug," he said. "The research and development and presentation of that is left to the drug companies themselves. And they can alter and change and present the drug in the best way possible."

    He credits this partially to the fact that drug companies purchase advertising in medical journals. "Every reputable medical journal in America is funded by drug company advertising. Journals wouldn't get out to doctors unless drugs were advertised in journals.

    "It's a culture of drug companies holding all the sway," Plumb continued. "They pay for everything. Even the way the information is dispersed to physicians. If you look at a journal and count how many pages are drug company advertisements and how many are studies, the drug companies outweigh the studies."

    Processing complaints about drugs and determining the impact of those complaints is a muddled process, according to Plumb, exemplified by the removal of Vioxx from the market and the resulting news that the studies about the drug were ghostwritten. Merck stopped selling Vioxx, a type of non-steroidal anti-inflammatory drug, in 2004 after evidence linked it to heart attacks. After the drug was taken off the market, more than 10,000 lawsuits were filed against Merck by former Vioxx patients or their families. In 2007, the company agreed to a $4.85 billion settlement.

    The following year, it was revealed that the studies on Vioxx were ghostwritten. According to a New York Times article from April 2008, Merck & Company conducted research on Vioxx and concealed its role in the studies by paying prominent scientists to lend their names to them.

    The total number of deaths that can be credited to Vioxx is unknown, but Dr. David Graham, in testimony before the U.S. Senate, estimated that 88,000 to 139,000 Americans experienced heart attacks as a side effect from the drug, and 30 to 40 percent of those died, resulting in 27,000 to 55,000 deaths due to Vioxx.

    "We gave up on the FDA," Fuller said. "They're useless. They went from being the finest regulatory agency in the world to the worst."

    The FDA maintains the system MedWatch, which is used to report adverse effects to drugs. Manufacturers are required to file a report with MedWatch if a patient reports any reactions to a medication. According to Fuller, the system is severely flawed.

    "The FDA throws away 75 percent of those reports, and the rest go into a database that people can't access except the FDA," he said. "In 1996 they changed over to a different database and everything that happened prior to 1996 you can't get access to. They pretty much wiped out a history of adverse reactions and gave drug companies a clean slate."

    According to Plumb, the culture of prescriptions in American heath care is in need of examination and possible revision.

    "Doctors are fed a lot of propaganda from drug reps, and they are influenced in a way that may not be best for the patients. Patients should not blindly put their trust in doctors. I think patients need to be their own health advocates today and do their own research."
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