When, near the end of one of the drug industry’s ask-your-doctor commercials, a fast-talking disembodied voice reads off a long list side effects, usually over a scene involving fields of waving grass and a puppy dog, it tends to sound like a lot of nasty stuff that's going to happen to someone else.
But while reading and writing about the pharmaceutical industry over the past couple of years, I started wondering about what life is like for the real people who are hit with those side effects.
Then last fall, when my own father was prescribed two popular antibiotics, I didn't have to wonder any longer.
He, like the people in those published case studies, was a victim of a specific class of antibiotics known as fluoroquinolones. Clinical trails typically find that one to two percent of people taking these drugs --among the most familiar of which are ciprofloxacin (Cipro) and levofloxacin (Levaquin) – experience serious side effects, most often psychiatric and central-nervous-system problems.
Pay a quick visit to an online fluoroquinolone discussion group, and you’ll be treated to the kind of graphic detail that isn’t included in ask-your-doctor ads: accounts of searing pain, psychosis, blistering skin, muscle-wasting, tendon rupture, hallucinations, insomnia, suicidal thoughts, and panic attacks.
Since he published a paper on fluoroquinolone side effects in 2001, says Dr. Jay Cohen, a medical researcher and associate professor at the University of California, San Diego, "I have received several hundred emails, most of which relate terrible, often catastrophic reactions that are slow to pass, leaving some people disabled for months or years."
In his book Bitter Pills: Inside the Hazardous World of Legal Drugs (Bantam Books, 1999), Fried describes a 1993 FDA advisory committee meeting he attended, in which government and drug-company officials haggled over possible new warnings to be put on fluoroquinolone labels and inserts. Fried helped FDA researchers make their case, but, he wrote in the book, "The doctors leading the [G.D.] Searle [and Company] delegation said something that almost caused me to have a seizure."
"As you know," that doctor told the group, "physicians will not even look at the package insert. If they do, it’s for seconds."
The US military dispensed 30 million doses of Cipro to troops before and during the first Gulf War, to ward off an anthrax attack that never came, and there was panic-buying of the drug again in 2001 in response to the real anthrax attacks of that year.
Having acquired a reputation as a superdrug despite reports of serious side effects, Cipro was joined by dozens of older and younger chemical cousins to form the most frequently prescribed class of antibiotics in the US today.
My father learned the hard way how and risky those drugs are when, after 77 years of excellent health, he had emergency heart surgery in October.
A few weeks after he had abruptly regained his ability to walk and was discharged, I obtained my father’s hospital file and saw that both serious declines in his condition had coincided closely with courses of fluoroquinolones – one with Levaquin, the other with moxifloxacin (Avelox) – that he’d been given to treat a potential case of pneumonia.
Each time the drugs were stopped – the second time we did so in mid-course, desperate to halt his deterioration – he improved. His doctor has since concluded that he never actually had pneumonia.