Kristen Pettigrew was only 23 years old when she became one of the more than 128,000 people each year who die from an Adverse Drug Reaction (2). Unfortunately, in Kristen’s case, who was previously healthy until she got a garden variety ‘moderate’ case of bronchitis, she sought help from medical professionals, was given the Fluoroquinolone antibiotic Avelox, and ultimately died as a result of taking the antibiotic.
Her death, however, was completely unnecessary and many studies have been done that show little to no benefit for an otherwise healthy person to receive antibiotics for bronchitis, an illness that is generally self-limiting. In fact, a study, called a ‘metanalysis’ that analyses all of the studies that have been done on a particular topic, looked into the topic of antibiotics for bronchitis and came to the conclusion that “An evaluation of the current literature does not support antibiotic treatment for acute bronchitis” (3).
We can only speculate as to whether her doctor was aware of these studies, however, it’s a doctor’s job to be aware of the latest science, and since bronchitis is an extremely common illness, he had a duty to know the science. However, one study on the subject found that “The widespread belief among patients that infection is the problem and antibiotics the solution has considerable influence on prescribing by general practitioners, even when they judge that antibiotics are not definitely indicated”. So even if her doctor did know the science, he may have still prescribed the antibiotic knowing it to be unnecessary- even with all of the risks that come with the drug, including death.
Critics will claim that her reaction was ‘rare’, and that no one could have predicted such a terrible outcome from the giving of just an antibiotic, however, that is the point. No one can predict what will happen to a particular person when taking a drug, which is why their use is limited to the requirement to go to a doctor to get them. Doctors are supposed to be the buffer that makes their use safer since not just anyone can go to the store and get antibiotics. Yet studies show that up to 30% of all prescribed antibiotics, such as the ones in Kristin’s case, are prescribed unnecessarily.
Another buffer against misuse of pharmaceuticals in the United States is the US, the Food and Drug Administration, the FDA. They are supposed to ‘vet’ drugs, making sure they are safe and effective, and approve them for indications of particular illnesses and offer warnings about their usage, but a recent Harvard study showed that the FDA is, in reality, doing exactly the opposite, and is allowing dangerous drugs on the market for the benefit of pharmaceutical companies, leading the author to conclude, in an article published by the Safra Center for Ethics, “we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs”(5).
Obviously, the buffer of protection against misuse of antibiotics has failed us all, most of all Kristin and her family.
Additionally, Kristin was prescribed Avelox, a drug in the class of Fluoroquinolone Antibiotics, which pose their own unique risks, with such a broad multitude of disabling and damaging Adverse Drug Reactions, that their use is limited to serious illnesses, such as chronic bronchitis for which tests had identified the bacteria responsible. But no tests were done on Kristin, and the Avelox was given to her ‘off label’, which means that it is used for conditions or on people for which the FDA has not approved based on physician judgement only. Off-label prescribing overrides the entire FDA process of approving drugs anyway, making the farce of FDA approval even more farsical. In fact, off-label prescribing of the Fluoroquinolones is more common than prescribing for their FDA approved use!
“A study this year funded by the National Institutes of Health reviewed 100 emergency room prescriptions for fluoroquinolones and found that only 19 were written for appropriate conditions and only one was given in the correct dose and for the proper duration.’ (6)
That in spite of FDA warnings that such prescribing was almost certainly inevitable. In fact, Robert Danner, a critical care expert at the NIH stated, “I am absolutely convinced that the drug [Avelox] will be used differently once it’s marketed frequently.” His statement was prophetic, but did not help to save Kristin Pettigrew.
The moral here is that drugs have consequences, and that the buffer intended to protect patients from dangerous drugs is all but gone. The remedy is that we cannot trust the so-called ‘experts’, the doctors who are giving these drugs, or the FDA that approves them, to be looking out for our best interests. We must do our own due diligence and question everything we put into our bodies, whether it be drugs, supplements, food, or water. We must be our own best doctors and look out for our own best interests, no matter how inconvenient or time-consuming that may be.
(1) FDA oversight of ‘off-label’ drug use wanes as prescriptions rise
(2) Harvard Study on Institutional Corruption in the FDA and Big Pharma
(3) Randomized placebo-controlled trials of antibiotics for acute bronchitis: a critical review of the literature
(4) Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet
(5) Risky Drugs: Why The FDA Cannot Be Trusted
(6) FDA oversight of ‘off-label’ drug use wanes as prescriptions rise