How sick are you? It depends on what the definition of ‘sick’ is…

Oct 29, 2008
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By Mary Gabb (mary.gabb@rxcomms.com )

The publication several years ago of Selling Sickness: How the World’s Biggest Pharmaceutical Companies are Turning Us All into Patients by Ray Moynihan and Alan Cassels has brought the concept of disease-mongering into a global debate, and has introduced (or reintroduced) terms such as “medicalisation” and “lifestyle drugs” into today’s lexicon.

An entire issue of PLoS Medicine was devoted to the topic in 2006. The first international conference on disease-mongering took place in 2006 in Newcastle, Australia. Disease-mongering even has its own Wikipedia page.

Moynihan and colleagues define disease-mongering as “widening the boundaries of treatable illness to expand markets for those who sell and deliver treatments”. It “turns healthy people into patients, causes iatrogenic harm, and wastes precious resources”. In short, disease-mongering is purported to make us believe we are sick (or more sick than we really are) so that we will buy more drugs to cure what ails us (or at least make us happier). Iona Heath, MD* has said it exploits our deepest atavistic fears of suffering and death.

Possible disorders susceptible to disease-mongering
Attention deficit hyperactivity disorder
Bipolar disorders
Erectile dysfunction
Restless legs syndrome
Social anxiety disorder

Those who say that pharmaceutical companies promote disease-mongering point to the recent upsurge in diagnoses and treatments for numerous conditions (see right) , asking whether some of these are even real conditions, or whether the stated prevalence is as broad as commonly stated by both medical professionals and the media.

In fact, disease-mongering proponents lay the blame for this alleged deception on several participants with Pharma affiliations: medical professionals (who are duped by Pharma via pharma-sponsored continuing education, especially in the United States), patient advocacy groups (also influenced by Pharma sponsorship to further their cause by “raising disease awareness”), and the mass media (who have a propensity to exaggerate a problem to sell their product and rely on lazy journalism in which facts such as prevalence statistics are never questioned).

In fact, as Drs Steven Woloshin and Lisa M. Schwartz* note, disease-mongering stories have all the ingredients for what is considered “good journalism”: compelling personal anecdotes, public health crises, uncaring or ignorant doctors, and miracle cures. Much like the field of pharmacoeconomics, the pursuit of disease-mongering involves multiple disciplines (beyond medical science and economics) such as public health policy, sociology, psychology, anthropology, and patient advocacy.

The idea of questioning the diagnosis of conditions such as bipolar disorders, menopause, or erectile dysfunction (ED) is sure to ruffle some feathers. While the symptoms of menopause or ED may be a “troublesome inconvenience” for some, they can be debilitating and/or terribly embarrassing for others, affecting long-term personal relationships and self-esteem.

Is it disease mongering? NO

We live in an era in which each generation has lived longer and better than the preceding one. We expect the most out of quantity and quality of life, simply because it is possible. Is that wrong?

Second, let’s be honest – Pharma products are addressing consumer needs, not medical science. Push-pull marketing has been around for ages, long before direct-to-consumer advertising. However, the danger is that Pharma is one of the few industries where profit-making activities have ethical overtones.

Third, the search for a biologic basis of disease and a reconsideration of what is normal has also led to some conditions being de medicalised, such as homosexuality.

Fourth, disease-mongering is not universally defined. Moynihan admits that the first step to studying possible disease-mongering is to create an operational definition.

Is it disease mongering? YES

The availability of so many pills and potions to address every ache, pain, and risk factor (which is treated as a disease state) runs the risk of removing the patient’s responsibility for any lifestyle changes that would help to address the condition. The impetus to reduce risk factor exposure (such as stress, tobacco smoke) is removed so the condition may be treated but the underlying potential causes remain. And, as noted by Iona Heath, MD, the irony is that such profit-driven practices of Pharma marketing “poisons the present in the name of a better, or at least a longer, future”.

Note also the increasingly stringent definitions of what are considered to be optimal measures of health, for example blood pressure, cholesterol, and weight. Achieving these levels through diet and exercise alone may be possible only for the truly devoted, but “we do happen to have a pill that will reduce your______”.

As discussed by Dr Olavo B. Amaral**, the struggle over disease-mongering may force us (ie, those involved directly or indirectly in the practice of medicine and medical consumers) to consider diseases as spectra rather than binary states (i.e., sick or well), and patients can decide, by working with their physicians, if they are sick enough for treatment and whether the treatment is worth the risk of the adverse events.

*Drs Heath, Woloshin, and Schwartz were authors of two of the articles from the PLoS Medicine issue on disease-mongering. Dr Heath is a general practitioner in London , UK . Drs Woloshin and Schwartz are at the Veterans Affairs Outcomes Group in Vermont , USA , and the Center for the Evaluative Clinical Sciences at Dartmouth Medical School , New Hampshire , USA .

**In a Letter to the Editor in PLoS Medicine.

Preventing medication errors

Sep 29, 2008
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By David Woods (david.woods@rxcomms.com)

“Since 2000, the US Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. These reports are voluntary, so the number of actual medication errors is believed to be higher,” says Carol Holquist, director of the division of medication error prevention in the FDA’s Center for Drug Evaluation and Research.

The FDA works with many partners to track medication errors, one of which is the Institute for Safe Medication Practices (ISMP), based in a Philadelphia suburb. They review drug names, rejecting some 25% of the 400 submitted each year; and they examine drug labelling and packaging.

Occupying the same building as the ISMP, and a wholly-owned subsidiary of the Institute, is a company called Med-E.R.R.S – the letters standing for Error Recognition and Revision Strategies. The company’s CEO, pharmacist Susan Proulx (pictured left), says that while they don’t invent drug names – that’s a whole other speciality – they do work with names, to test for possible confusion, and therefore error. She cites as examples the similar-sounding cholesterol drug Omacor and the anti-bleeding drug Amicar. They also had similar dosages. Eventually, in concert with the FDA, Omacor became Lovaza.

Similarly, Med-E.R.R.S works with graphics people to ensure that labelling and packaging are designed for maximum information and minimal likelihood of confusion. As Proulx puts it: “We put great emphasis on the design of the package label; it must be unambiguous… and the first priority is the name of the drug and the dosage.”

The company has worked with over a hundred pharma companies in its ten-year history, and relies on a group of doctors, nurses, pharmacists, and other professionals to review and assess names and labels. They work mainly online and receive a small honorarium for their involvement. One test is to produce a handwritten version of a new drug name and show it to pharmacists who assess its potential to be confused with another product.

Med-E.R.R.S uses a sophisticated analytical tool called FMEA. It’s commonly used in the aviation and automotive industries, as well as by NASA, and stands for Failure, Mode, Effect, Analysis. Says Proulx: “If a car’s steering wheel failed, you’d look at that; then see how it happened; then see the result (such as loss of control) and then find out why.”

Check www.fmeainfocentre.com for more details of how this works.

Medication errors can be approached along the same lines. Most occur for a variety of reasons, such as miscommunication of drug orders through poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units. The FDA’s Holquist says that they “usually occur because of multiple complex factors. All parts of the healthcare system – including health professionals and patients – have a role to play in preventing medication errors.”

And a major part of that role is played by organisations like ISMP and Med-ERRS.

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