The Worst of Side Effects
Is growing awareness of unwanted drug effects good or bad for patients?
Not all drugs are fully understood, which is why unanticipated side effects can occur. In recent years, there has been growing acknowledgement of a severe – and even more counterintuitive – drug effect: suicide, with a number of drugs, particularly antidepressants, under scrutiny. GlaxoSmithKline, for example, has faced a number of lawsuits regarding Paxil. And in a landmark case in April, GSK was even ordered to pay $3 million in damages to the family of a suicide victim who had been taking a generic version of Paxil (1). Clearly, there is a discussion to be had over whether the innovator drug community should be broadly liable for generic versions of its drugs, but that is a topic for another time…
Quantifying suicidal behavior is difficult, particularly in depressed or psychotic patients (over 90 percent of suicide victims suffer from clinical depression or other mental health disorders), but studies have shown a link between suicide ideation and some prescription drugs, particularly in children and adolescents. A number of antidepressants in the US have had a black box label since 2004, and a study conducted in 2016 even claimed that antidepressants could double the risk of suicidal and aggressive behavior in young people (2). Not all suicides can be attributed to drug effects – but the pharma industry is certainly a big (and perhaps easy) target at a very difficult time for grief-stricken friends and family.
It also doesn’t help that the media often accuses drug companies of downplaying the risks of suicide ideation and other severe drug effects. In the previously mentioned GSK case, for example, attorneys for the suicide victim’s family allege that GSK failed to adequately warn the suicide victim’s doctor about the risks of Paxil (GSK, on the other hand, points out that label did provide warnings and that the wording is FDA approved).
It is very important that companies do not try to hide any side effects in studies, but there is also danger in over-emphasizing the risk of side effects – especially when it results in patients who refuse to take life-saving or life-changing medicines.
A thought-provoking study published in May followed patients before and after learning they were taking statins (rather than the placebo) – and highlighted the so-called “nocebo” effect (3), which describes side-effect reporting that is more common when a patient is aware of taking a given medication. Unfortunately, the study was funded by a statin manufacturer further fueling the pharma fire... Nevertheless, it does raise some questions: how strong is the nocebo effect with other medicines – and how is it affecting patient compliance in the short and long term?
Stephanie Sutton
Editor
- Reuters, “GSK must pay $3 million in generic Paxil suicide lawsuit: U.S. jury”, (2017). Available at: reut. rs/2pyTkLF. Accessed May 12, 2017.
- T Sharma et al., “Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports”, BMJ, 352 (2016). PMID: 26819231
- A Gupta et al., “Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase”, The Lancet, S0140-6736 (2017).
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