'I Thought I Was Dying': A Common Synthetic Antibiotic Can Cause Permanent Side Effects
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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.”
In 2008, Johnson & Johnson's drug Levaquin went on trial for causing tendon damage. Schedin v. Johnson & Johnson was held in federal court in Minneapolis. John Schedin, 82, filed the suit, claiming he ruptured the Achilles tendons in both feet after taking Levaquin. He claims Johnson & Johnson and its Ortho-McNeil-Janssen Pharmaceuticals unit did not warn doctors and patients of the drug’s association with tendon damage. Schedin won the case and was awarded damages of $700,000.