Disease Mongering: Something to Lose Sleep About

insomniaThe number of prescriptions dispensed for sleeping pills, benzodiazepines and other sedatives in Canada jumped from 16.4 million in 2006 to more than 20 million in 2011.  Use of the most-commonly prescribed sleeping pill in Canada,  Zopiclone (a so-called “Z” drug) neared doubled in this time period.

This has happened  despite the fact that sleeping pills such as benzodiazepines and the Z drugs are dangerous and intended for only one or two days’ use (infrequently). Sleeping pills are associated with serious adverse reactions such as addiction, initially experienced as  rebound insomnia, increased anxiety, panic and other problems. One recent study found that sleeping pill and sedative users had a higher risk of cancer and a greater than threefold risk of death even when exposed to fewer than 18 pills a year. Sleeping pill and sedative use is also strongly associated with an increased risk of automobile accidents and is a major contributor to falls and hip fractures.

Research indicates that the effectiveness of sleeping pills is short-lived, making them not much more effective than placebos. Data from the largest trial  found that Sonata (zaleplon), a drug approved by the US FDA in 1999, did not extend sleeping time. In fact, subjects on a 10-milligram dose and those taking a placebo both slept 6 hours 20 minutes on average. And those on the drug took 36 minutes on average to fall asleep during the first week of the trial, only 14 minutes less than the control group needed to fall asleep.

A meta-analysis of randomized, placebo-controlled studies found that sleep improvements from sleeping pills were minimal and any short-term benefits were far outweighed by the risks of having an adverse drug reaction.

Could it be that the growing use of sleeping pills and diagnosis of sleep “disorders” is being driven by “disease-mongering”? The medicalization of ordinary life experiences through a variety of methods is a tactic employed by the drug industry and includes public “awareness” campaigns that lead to fear-mongering, ”ghost writing” by researchers working for pharmaceutical and medical device companies, and the slow integration of new definitions (supported by screening and diagnostics) into public consciousness, and clinical practice guidelines.

Canadians are being told that lack of sleep is associated with weight gain, high blood pressure, poor performance and low work productivity. The US Centres for Disease Control and Prevention have classified insufficient sleep as a public health “epidemic” affecting 70 million people. The national American Insomnia Study, funded by Sanofi-Aventis, concluded that insomnia costs the American economy $63 billion a year in lost productivity. A more recent study found that Suvorexant, an investigational sleep drug, was effective, but unfortunately, as one neurologist noted, the study was funded by Merck and conducted by company scientists, and thus, “the potential for conflict of interest is overwhelming”. It’s no surprise that Merck wants to get into sleeping pills – its competitors have already shown that the market is worth many billions of dollars.

The Canadian Sleep Society is a national organization at the forefront in promoting public awareness of the importance of sleep research and the increase in the incidence of sleep disorders in Canada. Among its five major financial supporters are Valeant Pharmaceuticals, one medical products company that sells sleep devices and three sleep clinics that undertake sleep testing and diagnostic procedures.

Sleep disorders are big business. In 2006, the US Institutes of Medicines reported that “Hundreds of billions of dollars a year are spent on direct medical costs related to sleep disorders such as doctor visits, hospital services, prescriptions, and over-the-counter medications”. There are now at least 130 sleep clinics in Canada, and even sleep disorders among children are identified as a problem. A consensus paper published in the BC Medication Journal in 2009 described the lack of adequate sleep among children and adolescents as “a major public health concern and even an epidemic”, problems that were poorly recognized and undertreated. Pharmaceutical companies and those who sell medical products and run diagnostic facilities, are heavily invested in diagnosing, screening and treating sleep disorders.

There is no question that many people have insomnia from time to time and that there may be more contributors to insomnia than ever before. Poor sleep hygiene habits, shift work, stress, overuse of alcohol, and the use of technology may be contributors. Many common prescription drugs such as Inderal (a beta-blocker), thyroid medications (Synthroid), antibiotics (Floxin) and decongestants containing pseudoephedrine are known to cause insomnia. Physicians can help by identifying these causes and assisting patients to eliminate the contributors to poor sleep.

Some have questioned the current standard by which “good sleep” or “poor sleep” is measured. Historian Roger Ekirch, suggests that it is more natural for human beings to sleep in distinct patterns of waking instead of 7-8 hours of continuous sleep. The advent of electricity, he has written, reduced the amount of time we spend in bed and parents were urged to force their children out of segmented sleep patterns. According to sleep psychologist, Gregg Jacobs, “For most of human evolution we slept in a certain way. Waking up during the night is part of human physiology”. Jacobs argues that anxiety can fuel sleeplessness and concerns about not sleeping may seep into the working day – which, in turn, may drive more anxiety, leading to more problems with sleeplessness.

A perfect environment for disease mongering.

On January 10, 2013, the U.S. Food and Drug Administration (FDA) issued a much-delayed safety alert concerning next-day sleepiness and the risk of traffic accidents caused by a group of drugs containing zolpidem. Ambien is probably the most familiar brand name and the first in the group of zolpidem-containing drugs to have been approved by the FDA. (worstpills.org)

About the Contributor

Janet Currie is a consumer advocate for the safe and informed use of prescription drugs and medical products. She runs a website on the risks associated with psychiatric drugs and sleeping pills and the pathologizing of normal human phenomena (www.psychmedaware.org). She was a member of Health Canada’s Expert Advisory Committee on the Vigilance of Health Products between 2007-2011) and she co-edits the Pharmawatch blog with Colleen Fuller.