'I Thought I Was Dying': A Common Synthetic Antibiotic Can Cause Permanent Side Effects
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This case is the first trial of more than 2,600 claims in U.S. courts alleging that Levaquin causes tendon damage. In 2008, the FDA required an upgraded warning on tendon damage posed by Levaquin and similar drugs. The black box warning was required for all fluoroquinolones in July 2008.
The warning is a result of the efforts of Public Citizen, a non-profit, consumer rights advocacy group, which filed a lawsuit requiring the warning on the drugs’ packaging and requiring pharmacists to give patients FDA-approved medication guides that also carry the warning.
“There were letters sent out in 2008, telling doctors that these drugs can blow a man’s tendon,” Fuller said. “They only came out after a 12-year battle. Public Citizen started fighting this in 1996. We had to sue the FDA in federal court to get them to review these petitions that we filed.”
Following the issue of the black box warnings, Fuller said the FDA downplayed the effect. Renata Albrecht, the head of the FDA's Division of Special Pathogen and Transplant Products, estimated that spontaneous ruptures were occurring in approximately one in 100,000 people. The FDA said taking the drugs appears to triple or quadruple the risk, bringing a total of four out of 100,000 people who are at risk.
The study, “Increased Risk of Achilles Tendon Rupture With Quinolone Antibacterial Use, Especially in Elderly Patients Taking Oral Corticosteroids” presents a total of anywhere from four to 28 out of 100 patients instead of four out of 100,000 patients, the total presented by the FDA.
Confusing or inaccurate statistics concerning medical research are not unusual. The process of approving a drug for use is fraught with conflict of interest, according to Plumb. In 2007, the FDA issued guidelines barring advisers with more than $50,000 invested in an FDA-regulated drug or medical device company unless they receive a waiver from the agency. People with financial interests of less than $50,000 can participate on the panel but are unable to vote without a waiver from the agency.
“There were no laws against drug company officials physically being on the committee up until a few years ago,” Plumb said. “The Levaquin lawsuit is the tip of the iceberg. It’s a convenient way to mask the other problems it can cause that are more prevalent.”
According to Plumb, the culture of prescriptions in American heath care is in need of examination and possible revision.
“It’s the lesser of two evils,” Plumb said. “Doctors are making decisions over and over. Medications can cause problems, but they save lives. They take that argument and extend it to say medications don’t usually cause problems, so I’ll give it and hope it doesn’t cause problems. We’re a cultured society that believes that antibiotics in particular are lifesaving and we really need them. Heaven forbid that they are actually causing problems in patients.”
In order to increase awareness about fluoroquinolones, Plumb said many aspects of the system are in need of change, including the education received in medical schools. He said very few continuing education courses have much to do with the pharmacy, and if they do, a doctor presents pharmaceutical research in a positive light.
The presentation of research is also a problem in the sale of pharmaceuticals, according to Fratti. Having once worked as a sales representative, he experienced firsthand the culture of pharmaceutical sales and the influence representatives had on doctors.
“We were trained how to downplay or trivialize doctors’ concerns,” he said. “We had role-playing sessions, videotaped and graded on how skillful we were able to do that. Pharmaceutical sales are not about educating a doctor. It’s about marketing a doctor and selling the doctor to make sure the doctor sells your drug.”