October2008

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

Oct 29, 2008
No Comments Yet
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
Depression
Erectile dysfunction
Menopause
Obesity
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.

Development Safety Update Reports (DSURs): simplifying periodic safety reporting

Oct 29, 2008
No Comments Yet
By Robert Hand (robert.hand@rxcomms.com)

The US Food and Drug Administration (FDA) in August proposed a new guideline asking the sponsors of clinical trials to submit annual development safety update reports (DSURs). The guideline, titled “E2F Development Safety Update Report,” is in draft form and describes the format, content, and timing of a DSUR. It specifies that a DSUR update the status of the clinical trial, summarise the sponsor’s understanding and management of identified and potential risks, describe new safety concerns that could affect the protection of trial subjects, and examine whether the information collected in the previous year accords with current knowledge of the product’s safety.

DSURs would be required for investigational drugs, including biologicals, with or without marketing approval, and whether or not the clinical trials are being conducted by commercial or non-commercial sponsors. A DSUR would have to be submitted within 60 days of the DSUR data lock-point, determined by the date of the sponsor’s first authorisation to conduct a clinical trial in any country (the “Development International Birth Date”).

The guideline instructs sponsors to focus on data from interventional trials. However, it also advises the inclusion of other findings that may have a bearing on the safety of trial subjects. Such information could include findings of non-clinical trials, as well as clinical trials conducted by the sponsor’s development partners and non-interventional or compassionate-use studies.

The FDA draft guideline matches one developed by the International Conference on Harmonisation (ICH).

Will DSURs create more work for the sponsors of clinical trials? Apparently not, at least in the long run. First, the guideline follows a standard format that has been developed for submission in the three ICH regulatory regions (the United States , the European Union, and Japan ). A report produced in accordance with the guideline could be submitted simultaneously in all three regions. Second, the DSUR would replace some reports that are currently required, such as the IND Annual Report. For already marketed products, some of the information required for the DSUR may be provided in the periodic safety update report (PSUR), on which the DSUR is patterned.

The draft guideline may be obtained online at www.regulations.gov or www.fda.gov/cber/guidelines.htm. The FDA has solicited comment on the draft. To be useful, comments should be submitted by 3 November 2008.

Conquering chaos: six steps to an organised office

Oct 29, 2008
No Comments Yet
By Julie Stauffer (julie.stauffer@rxcomms.com)

How quickly can you lay your hands on tomorrow’s meeting agenda, the latest batch of clinical data, or the draft report you’ve been asked to review? Although de-cluttering your desk may fall low on your low priority list, disorganisation carries a hefty price tag.

A Gartner Group study revealed that the average company loses one out of every 20 documents and spends US$120 in labour to track down each one that goes missing in action. Nor are the costs strictly financial. Untidy offices are a source of stress for 43% of American workers, according to a survey by office supplies manufacturer Esselte.

Need an added incentive to get organised? Esselte also found that 52% of UK managers consider the state of your desk during employee appraisals.

If you’re ready to regain control of your desktop, here’s a six-step plan:

1. Clear the decks

Block off a couple of hours, haul out the recycling bin and get ready to pitch the unnecessary documents cluttering your desktop and crammed into your cabinets. To decide what stays and what goes, Barbara Hemphill, author of Taming the Paper Tiger , suggests a few key questions:

  • Does this piece of paper require action?
  • Is it recent enough to be useful?
  • Would it be difficult to find this information somewhere else?
  • Are there tax or legal implications to throwing it out?
  • Can you identify a specific use for it?

If the answers are “no,” you can toss out the document with a clear conscience.

2. Organise your files

Every piece of paper in your office should have a home. Group like with like: put financial files in one place, for example, and scientific papers in another. For maximum efficiency, keep the files you’re currently working on close at hand. Compiling a master list of all your files will help you locate information quickly.

3. Develop a dating habit

You’ll save yourself a lot of headaches by dating every piece of paper and marking documents as either “draft” or “final.” When a project is complete, ditch all the drafts and keep just one copy of the final version.

4. Triage incoming paperwork

When a document hits your desk, decide whether to toss it, file it for future reference, or act on it. If you can’t act until you’ve received approval or input from someone else, put the document in your “pending” file and make a note on your calendar to follow up if you haven’t heard back within the allotted time.

5. Create a to-do list

While it may be tempting to leave a folder on your desk as a reminder to take action on it, file it away and add a note to your to-do list instead. If there’s a specific deadline, make a note on your calendar as well.

6. Make a daily commitment

Once you have a system in place, investing just a few minutes a day will keep it running smoothly – and avoid hours of frustration hunting down misplaced documents.

  • Twitter feed loading...