Depression is 'over-diagnosed'

Depression is 'over-diagnosed'

Joined: April 1st, 2004, 4:56 pm

August 17th, 2007, 9:31 am #1

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</DIV></TD></TR></TBODY></TABLE><!-- E IIMA --><!-- S SF -->Too many people are being diagnosed with depression when all they are is unhappy, a leading psychiatrist says.
Professor Gordon Parker claims the threshold for clinical depression is too low and risks treating normal emotional states as illness.
Writing in the British Medical Journal, he calls depression a "catch-all" diagnosis driven by clever marketing.
But another psychiatrist writing in the journal contradicts his views, praising the increased diagnosis of depression. <!-- E SF -->
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<DIV>Professor Gordon Parker</DIV></DIV></TD></TR></TBODY></TABLE><!-- E IBOX -->
Professor Ian Hickie writes that an increased diagnosis and treatment of depression has led to a reduction in suicides and removal of the old stigma surrounding mental illness.
Under the current diagnosis guidelines, around one in five adults is thought to suffer depression during their lifetime. This costs the UK economy billions in lost productivity and treatment.
Professor Parker, from the University of New South Wales, in Australia, said the "over-diagnosis" began around 25 years ago.
Study of teachers
The professor, who carried out a 15-year study of 242 teachers, found that more than three-quarters of them met the current criteria for depression.
He writes in the BMJ that almost everyone had symptoms such as "feeling sad, blue or down in the dumps" at some point in their lives - but this was not the same as clinical depression which required treatment.
He said prescribing medication may raise false hopes and might not be effective as there was nothing biologically wrong with the patient.
He said: "Over the last 30 years the formal definitions for defining clinical depression have expanded into the territory of normal depression, and the real risk is that the milder, more common experiences risk being pathologised."
But Professor Hickie said if only the most severe cases were treated, people would die unnecessarily.
Marjorie Wallace, chief executive of the mental health charity Sane, said: "Depression can be a complex and challenging condition ranging from feeling low to being so disabled that the person may be unable to get out of bed in the morning, sustain relationships or work.
"It is not surprising that with such a wide range of symptoms, identification varies from one doctor to another.
"Sane believes that it is better to risk over diagnosis than to leave depression untreated. One in ten people with severe depression may take their own life."
The number of prescriptions for antidepressants in England hit a record high of more than 31 million prescriptions earlier this year - a 6% rise in two years.
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Joined: April 1st, 2004, 4:56 pm

August 17th, 2007, 9:32 am #2


Marjorie Wallace, chief executive of the mental health charity Sane, said: "Depression can be a complex and challenging condition ranging from feeling low to being so disabled that the person may be unable to get out of bed in the morning, sustain relationships or work.
"It is not surprising that with such a wide range of symptoms, identification varies from one doctor to another.
"Sane believes that it is better to risk over diagnosis than to leave depression untreated. One in ten people with severe depression may take their own life
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Joined: April 1st, 2004, 4:56 pm

August 17th, 2007, 9:37 am #3


Professor Gordon Parker claims the threshold for clinical depression is too low and risks treating normal emotional states as illness.
Writing in the British Medical Journal, he calls depression a "catch-all" diagnosis driven by clever marketing.
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Joined: April 1st, 2004, 4:56 pm

August 17th, 2007, 9:41 am #4

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</DIV></TD></TR></TBODY></TABLE><!-- E IIMA --><!-- S SF -->Too many people are being diagnosed with depression when all they are is unhappy, a leading psychiatrist says.
Professor Gordon Parker claims the threshold for clinical depression is too low and risks treating normal emotional states as illness.
Writing in the British Medical Journal, he calls depression a "catch-all" diagnosis driven by clever marketing.
But another psychiatrist writing in the journal contradicts his views, praising the increased diagnosis of depression. <!-- E SF -->
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<DIV>Professor Gordon Parker</DIV></DIV></TD></TR></TBODY></TABLE><!-- E IBOX -->
Professor Ian Hickie writes that an increased diagnosis and treatment of depression has led to a reduction in suicides and removal of the old stigma surrounding mental illness.
Under the current diagnosis guidelines, around one in five adults is thought to suffer depression during their lifetime. This costs the UK economy billions in lost productivity and treatment.
Professor Parker, from the University of New South Wales, in Australia, said the "over-diagnosis" began around 25 years ago.
Study of teachers
The professor, who carried out a 15-year study of 242 teachers, found that more than three-quarters of them met the current criteria for depression.
He writes in the BMJ that almost everyone had symptoms such as "feeling sad, blue or down in the dumps" at some point in their lives - but this was not the same as clinical depression which required treatment.
He said prescribing medication may raise false hopes and might not be effective as there was nothing biologically wrong with the patient.
He said: "Over the last 30 years the formal definitions for defining clinical depression have expanded into the territory of normal depression, and the real risk is that the milder, more common experiences risk being pathologised."
But Professor Hickie said if only the most severe cases were treated, people would die unnecessarily.
Marjorie Wallace, chief executive of the mental health charity Sane, said: "Depression can be a complex and challenging condition ranging from feeling low to being so disabled that the person may be unable to get out of bed in the morning, sustain relationships or work.
"It is not surprising that with such a wide range of symptoms, identification varies from one doctor to another.
"Sane believes that it is better to risk over diagnosis than to leave depression untreated. One in ten people with severe depression may take their own life."
The number of prescriptions for antidepressants in England hit a record high of more than 31 million prescriptions earlier this year - a 6% rise in two years.
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<P id=slugline>BMJ&nbsp;&nbsp;2007;335:328&nbsp;(18&nbsp;August), doi:10.1136/bmj.39268.475799.AD

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http://www.bmj.com/cgi/content/full/335/7615/328

&nbsp;

Feature
<H2 class=sertitle>Head to head</H2>
Is depression overdiagnosed? Yes
<DIV class=Credits>
<STRONG>Gordon Parker</STRONG>, <EM>scientia professor</EM></STRONG></SUP>
</DIV>
School of Psychiatry, University of New South Wales, Randwick NSW 2031, Australia

<DIV class=Credits>
<SPAN id=em0>[url=mailto:g.parker@unsw.edu.au]g.parker@unsw.edu.au[/url]</SPAN>
<SCRIPT type=text/javascript><!--
var u = "g.parker", d = "unsw.edu.au"; document.getElementById("em0").innerHTML = '<a href="mailto:' + u + '@' + d + '">' + u + '@' + d + '<\/a>'//--></SCRIPT>

</DIV>
<P id=article_remark>Rates of diagnosis of depression have risen steeply in recent<SUP>
years. Gordon Parker believes this is because current criteria are medicalising sadness, but Ian Hickie argues that many people are still missing out on lifesaving treatment


It is normal to feel depressed. In our cohort study of 242 teachers, the 1978 baseline questionnaire defined depression as "a significant lowering of mood, with or without feelings of guilt, hopelessness and helplessness, or a drop in one's self-esteem or self-regard."1 Ninety five per cent of the cohort reported such feelings (with a mean of six episodes a year), indicating the ubiquitous nature of depressed mood states.
A low threshold for diagnosing clinical depression, however, risks normal human emotional states being treated as illness, challenging the model's credibility and risking inappropriate management. When the first antidepressant (imipramine) was developed, manufacturer Geigy was reluctant to market it,2 judging there were insufficient people with depression. Now, depression is all around, and antidepressant drugs have a dominant share of the drug market. Reasons for the overdiagnosis include lack of a reliable and valid diagnostic model and marketing of treatments beyond their true utility in a climate of heightened expectations.
Fifty years ago, clinical depression was either endogenous (melancholic) or reactive (neurotic). Endogenous depression was a categorical biological condition with a low lifetime prevalence (1-2%). By contrast, reactive depression was exogenous (induced by stressful events affecting a vulnerable personality style). In 1980, the American Psychiatric Association released and promoted the third revision of its diagnostic and statistical manual (DSM-III) as a reliable criterion based system. It radically divided clinical depression into major and minor disorders.
The simplicity and gravitas of the term "major depression" gave it cachet with clinicians (despite unpublished field trials suggesting that diagnostic allocation was less reliable than that in DSM-II3) and helped patients get medical insurance cover.4 Although its descriptive profile prioritised melancholic features (such as serious psychomotor disturbance or anergia), DSM-III's operational criteria were set "at the lowest order of inference." Criterion A required a "dysphoric mood" for two weeks, including feeling "sad, blue . . . down in the dumps." Criterion B (mandating four of eight listed items) could be met by some level of appetite change, sleep disturbance, drop in libido, and fatigue. Formal trials confirmed the low reliability of these criteria,4 and large US community studies showed variable lifetime prevalences—ranging from 6.3%5 to 17.1%6—that paradoxically fell with age. Why? Failure to recall lifetime episodes was shown to be greater for major depression than for other disorders,6 suggesting that its criteria capture less important (and forgettable) depressive states. Studies that assess cohorts at intervals (to overcome forgotten episodes) report much higher lifetime rates of major depression (such as 42% in our teachers' cohort7).
Minor DSM-III depressive disorder (dysthymia) homogenised less severe chronic conditions, requiring even fewer and less substantive symptoms (such as crying, decreased productivity, and feeling sorry for yourself). This dimensional model was subsequently extended by proposing an even less severe condition, subsyndromal or subclinical depression. Its one year prevalence in a US community database was nearly triple that of major depression, encouraging those investigators to argue for its "clinical and public health importance" and treatment.8

How low do we go?
Determining caseness for any dimensional construct requires imposing a cut-off, risking underdiagnosis of true cases or overdiagnosis of non-cases. By 1993, 79% of teachers in our cohort (in their late 30s) had already met symptom and duration criteria for lifetime major, minor, or subsyndromal depression (unpublished data). Although it was absolutely necessary to redress psychiatry's earlier weighting to melancholia, the extended dimensional model risks medicalising normal human distress and viewing any expression of depression as mandating treatment.
The reality that many people with substantive clinical depressive disorders still do not have their condition diagnosed does not, by itself, mean that depression is underdiagnosed. Such boundary concerns have multiple parallels. For example, the diagnosis of attention-deficit/hyperactivity disorder is often missed; conversely, it is often falsely diagnosed in children with other disruptive behaviours.

Does overdiagnosis matter?
Does current looseness matter if a low diagnostic threshold destigmatises depression, encouraging people to seek help and allowing clinical assessment? After all, breast screening programmes may lead to detecting more malignant lumps. However, false positives results generated by breast screening are filtered out by refined assessment, and harm rarely occurs. For false positive detection of depression, many of psychiatry's leaders mandate treatment, which for many with less severe conditions raises hopes but results in a sequence of ineffective and inappropriate treatments.
The ease of assigning a diagnosis of clinical depression, even of major depression, has rebounded on psychiatry, blunting clarification of causes and treatment specificity. As Hickie, who argues here against overdiagnosis, observed elsewhere: DSM-III defined major depression has failed "to demonstrate any coherent pattern of neurobiological changes [or] any specific pattern of treatment response outside in-patient treatment settings."9
Meta-analyses show striking gradients favouring antidepressant drugs over placebo for melancholic depression. Yet trials in major depression show minimal differences between antidepressant drugs,10 evidence based psychotherapies,11 12 and placebo. The benefit of treatment for the minor and subsyndromal depressions is even more unclear. Extrapolating management of the more severe biological conditions to minor symptom states reflects marketing prowess rather than evidence, ignoring Nobel Laureate Richard Feynman's observation that "Things on a small scale behave nothing like things on a big scale."
Depression is a diagnosis that will remain a non-specific "catch all" until common sense brings current confusion to order. As the American journalist Ed Murrow observed in another context: "Anyone who isn't confused doesn't really understand the situation."
</SUP>
<SUP>


<HR align=left width="30%" noShade SIZE=1>
<A name=""><!-- null --></A>Competing interests: GP is executive director of Australia's Black Dog Institute and has served on several pharmaceutical advisory boards and spoken at many meetings convened by drug companies.

References

<OL><A name=REF1><!-- null --></A>
<LI value=1></SUP>Parker G. Parental characteristics in relation to depressive disorders. Br J Psychiatry 1979;134:138-47.<!-- HIGHWIRE ID="335:7615:328:1" -->[Abstract]<!-- /HIGHWIRE --><SUP> <A name=REF2><!-- null --></A>
<LI value=2></SUP>Healy D. The anti-depressant era. Cambridge, MA: Harvard University Press, 1997.<!-- HIGHWIRE ID="335:7615:328:2" --><!-- /HIGHWIRE --><SUP> <A name=REF3><!-- null --></A>
<LI value=3></SUP>Kirk SA, Kutchins H. The selling of DSM. The rhetoric of science in psychiatry. New York: Aldine De Gruyter, 1992.<!-- HIGHWIRE ID="335:7615:328:3" --><!-- /HIGHWIRE --><SUP> <A name=REF4><!-- null --></A>
<LI value=4></SUP>Parker G. Beyond major depression. Psychol Med 2005;35:467-74.<!-- HIGHWIRE ID="335:7615:328:4" -->[CrossRef][ISI][Medline]<!-- /HIGHWIRE --><SUP> <A name=REF5><!-- null --></A>
<LI value=5></SUP>Robins LN, Helzer JE, Weissman MM, Orvaschel H, Gruenberg E, Burke JD. Lifetime prevalence of specific psychiatric disorders in three sites. Arch Gen Psychiatry 1984;41:949-58.<!-- HIGHWIRE ID="335:7615:328:5" -->[Abstract]<!-- /HIGHWIRE --><SUP> <A name=REF6><!-- null --></A>
<LI value=6></SUP>Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the national comorbidity survey replication. Arch Gen Psychiatry 2005;62:593-602.<!-- HIGHWIRE ID="335:7615:328:6" --><NOBR>[Abstract/<FONT color=#cc0000>Free</FONT>&nbsp;Full&nbsp;Text]</NOBR><!-- /HIGHWIRE --><SUP> <A name=REF7><!-- null --></A>
<LI value=7></SUP>Wilhelm K, Mitchell PB, Niven H, Finch A, Wedgwood L, Scimone, A, et al. Life events, first depression onset and the serotonin transporter gene. Br J Psychiatry 2006;188:210-5.<!-- HIGHWIRE ID="335:7615:328:7" --><NOBR>[Abstract/<FONT color=#cc0000>Free</FONT>&nbsp;Full&nbsp;Text]</NOBR><!-- /HIGHWIRE --><SUP> <A name=REF8><!-- null --></A>
<LI value=8></SUP>Judd LL, Paulus MP, Wells KB, Rapaport MH. Socioeconomic burden of subsyndromal depressive symptoms and major depression in a sample of the general population. Am J Psychiatry 1996;153:1411-7.<!-- HIGHWIRE ID="335:7615:328:8" --><NOBR>[Abstract/<FONT color=#cc0000>Free</FONT>&nbsp;Full&nbsp;Text]</NOBR><!-- /HIGHWIRE --><SUP> <A name=REF9><!-- null --></A>
<LI value=9></SUP>Hickie I. Issues in classification. III. Utilising behavioural constructs in melancholia research. In: Parker G, Hadzi-Pavlovic D, eds. Melancholia: a disorder of movement and mood. New York: Cambridge University Press, 1996:38-56.<!-- HIGHWIRE ID="335:7615:328:9" --><!-- /HIGHWIRE --><SUP> <A name=REF10><!-- null --></A>
<LI value=10></SUP>Parker G. Evaluating treatments for the mood disorders: time for the evidence to get real. Aust N Z J Psychiatry 2004;38:408-14.<!-- HIGHWIRE ID="335:7615:328:10" -->[CrossRef][ISI][Medline]<!-- /HIGHWIRE --><SUP> <A name=REF11><!-- null --></A>
<LI value=11></SUP>Parker G, Roy K, Eyers K. Cognitive behavior therapy for depression? Choose horses for courses. Am J Psychiatry 2003;160:825-34.<!-- HIGHWIRE ID="335:7615:328:11" --><NOBR>[Abstract/<FONT color=#cc0000>Free</FONT>&nbsp;Full&nbsp;Text]</NOBR><!-- /HIGHWIRE --><SUP> <A name=REF12><!-- null --></A>
<LI value=12></SUP>Parker G, Parker I, Brotchie H, Stuart S. Interpersonal psychotherapy for depression? The need to define its ecological niche. J Affective Disord 2006;95:1-11.<!-- HIGHWIRE ID="335:7615:328:12" -->[CrossRef][ISI][Medline]<!-- /HIGHWIRE --><SUP> </LI>[/list]
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Joined: January 1st, 1970, 12:00 am

August 17th, 2007, 10:20 am #5


<EM>Ray Moynihan: While the curriculum for these seminars is independently developed by Professor Hickey and his colleages, <STRONG>the funding is dominated by one company with a new anti-depressant on the market.</STRONG></EM>

<EM>Ray Moynihan: So what’s in it for the company then?</EM>

<EM>Professor Ian Hickey: "I think the obvious thing is for any company in this particular area, is that this is an <STRONG>under-used market</STRONG>. They need to be into the issues of not simply people changing from drug A, B, C to D. Now there are so many anti-depressants on the market, that’s not a great strategy. <STRONG>They, like everyone in this particular market, wants to see more people treated. From a public health point of view, we want to see more people treated</STRONG>."</EM>

<EM><STRONG>Ray Moynihan: Professor Ian Hickey is telling doctors that one in three people who walk into their surgeries, are psychologically sick and perhaps one in six might require a combination of drug treatment and non-drug treatment</STRONG>.</EM>

<EM>Ray Moynihan: Do you really expect people to believe that the problem is that large?</EM>

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http://www.abc.net.au/science/slab/medicine/trans2.htm


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<FONT face="arial, helvetica" size=4>TRANSCRIPT: Drugs, (episode two)
</FONT><FONT face="Arial, helvetica" size=2>Thursday, November 19 at 8.00 pm </FONT>

&nbsp;

Dr David Eddy: "They gave me a suite and five star hotels on each occasion. And I came away from that experience just kind of liking the drug company."

Professor John Eisman: "I have no doubt that companies will promote diseases for which they have a product."

Professor David Henry: "The costs of medications are spiralling. We are not going to be able to afford all the drugs that they want to sell."

Ray Moynihan: Welcome to "Too Much Medicine?". I’m Ray Moynihan. Last week we looked at surgery and the poor evaluation of common operations. This week, the focus shifts to pharmaceuticals which, by and large, are much better evaluated. But tonight, there are different questions.

Drug companies spend over a million dollars a day pushing their product. But they’re not just selling pills, they’re increasingly promoting the diseases to go with them. And while all the corporate sponsored education may have clear benefits, it may be time to ask, "at what cost?"

<P align=center>Sub-title Part 2: Drugs
Ray Moynihan: A painful shoulder on the golf course took Joan Southern off to a visit to her local doctor.

Joan Southern "I had a very sore shoulder and it was giving me pain at night. And I thought, "Oh, I’ll go to the doctor and see what’s the matter with my shoulder," so I went and she decided it had something to do with the calcium of the bone in the shoulder and said she’d prescribe some anti-inflammatory tablets for me."

Ray Moynihan: Three weeks later at the end of the course of the anti-inflammatory tablets, Joan would become extremely ill.

Joan Southern: "The Saturday I wasn’t feeling very well and I was feeling quite clammy, and I vomited. It was like blood but it wasn’t blood. It was just black."

Ray Moynihan: Joan was rushed to Newcastle’s Mater Hospital, after having passed out at home. She was suffering massive internal bleeding, caused by the tablets themselves. And on arrival at Casualty, she required an urgent blood transfusion.

Joan Southern: became one of the fifty thousand Australians a year who turn up at our hospitals because they’re hurt by the medications which are supposed to help them.

Professor David Henry: University of Newcastle
"Joan’s situation became serious. She developed ulceration in the stomach, caused by the drug and she developed haemorrhage from it and that haemorrhage was quite brisk, quite substantial bleeding, probably not life-threatening in her case, thank goodness, but it could’ve been and this is a serious side-effect of these drugs."

Ray Moynihan: Many older Australians take anti-inflammatory drugs, often giving great relief from the pain of arthritis but evidence suggests these pills are widely over-used, sometimes for problems which might be better treated without any medications.

Ray Moynihan How serious was the shoulder problem to start with?

Joan Southern: "Not as serious as this has been. Not to me. I mean, I’m still quite sore in the shoulder but not, you know, in that respect. I mean, I can wear the shoulder, but I didn’t like the thought of the haemorrhage. It wasn’t good, particularly when he said it could be, it could’ve been much more serious had I not been such a healthy person."

Ray Moynihan: The amount Australia spends on prescription pills is rapidly rising and is now more than three billion dollars a year. A big part of that rise is due to the increased prescription of the latest, most expensive medications.

And while that’s good news for the companies selling them, the most profitable drug may not always be the most appropriate or necessary for the patient.

Professor David Henry: "I would say that overall, maybe as high as twenty percent of total prescription drug-use in this country is either excessive or inappropriate and by inappropriate I mean that other simpler and cheaper remedies would suffice. And that translates into a drug bill that might be four to five hundred million dollars."

Ray Moynihan: Why is there so much unnecessary or inappropriate prescribing?

Professor David Henry: "Quite a lot of it’s due to promotion of drugs."

Ray Moynihan: When these psychiatrists stream out of their lectures about the non-drug treatment of depression, the dominant images here, are all about drugs.

The Royal College of Psychiatrist’s Annual Congress looks more and more like a drug fest.

Professor David Henry: "The striking thing when attending scientific conferences, is the presence of the industry. It’s the thing you’re most aware of, so that, at a conference that is genuinely concerned with science and scientific communication, often the messages that you receive, if you aren’t careful, are largely concerned with market share and profit."

Ray Moynihan: Along with the free ice cream, there’s give-away umbrellas, teddy bears and the Serzone sample bags.

Pat Clear: Australian Pharmaceutical Manufacturers Assoc.
"The giving away of those sorts of gifts is very strictly controlled by the association’s code of conduct and that of course, has received the approval of Australia’s top industry watch dog, if you like. But really, these gifts are very small and they’re intended to reinforce brand names."

Professor David Henry: "It’s very difficult for the profession to think back and use simpler, older, perhaps non-drug remedies, when they’re continually surrounded by this. They’re continually bombarded by information about new drugs."

Pat Clear: "The newer medicines, in most cases, are going to be the more effective ones. And they have already demonstrated cost-effectiveness to the Australian government before they get listed on Pharmaceutical Benefits Scheme. So in fact, you’re trying to tell the doctor about the newest, latest medicines, which are likely to be more effective, than the older, cheaper ones."

Ray Moynihan: Another of the drug company’s promotional strategies is sponsoring the education of your local GP and, tonight, it’s about depression.

Professor Ian Hickey <STRONG>University of New South Wales
</STRONG>"Doctors need a lot of skills, not just details of each particular drug. Drug marketing or drug education tends to focus on simply detailing the components or the benefits or disadvantages of each particular drug. <STRONG>You need people like universities, government involved, to give a wider perspective and to really give some legitimate comparison </STRONG>of the value of drug versus non-drug treatments and then the relative benefits of each of the drug classes available."

Ray Moynihan: While the curriculum for these seminars is independently developed by Professor Hickey and his colleages, the <STRONG>funding is dominated by one company with a new anti-depressant on the market</STRONG>.

Ray Moynihan: So what’s in it for the company then?

Professor Ian Hickey: "I think the obvious thing is for any company in this particular area, <STRONG>is that this is an under-used market</STRONG>. They need to be into the issues of not simply people changing from drug A, B, C to D. Now there are so many anti-depressants on the market, that’s not a great strategy. They, like everyone in this particular market, wants to see more people treated. From a public health point of view, we want to see more people treated."

Ray Moynihan: Professor Ian Hickey is telling doctors that one in three people who walk into their surgeries, are psychologically sick and perhaps one in six might require a combination of drug treatment and non-drug treatment.

Ray Moynihan: Do you really expect people to believe that the problem is that large?

Professor Ian Hickey: "No, I think we have a big problem at the public health end and also at the general practitioner end, the doctor end. We’ve not had very good public awareness of the size of the mental health issues, nor of the size of the problem to deal with. We are very fortunate that we have actually collected data in Australia now, <STRONG>under the national mental health strategy</STRONG>, to demonstrate that. And these are not trivial disorders."

Ray Moynihan: Without wanting to play down for a minute the legitimate severe mental illness out there, <STRONG>aren’t you, by saying things like that, by publicising such huge estimates, helping build a very large market for those selling cures</STRONG>?

Professor Ian Hickey: <STRONG>"Yes, I don’t see that as a problem at all.</STRONG> It’s like talking about the market for immunisation. A hundred percent of children need to be immunised. Now, in putting forward that public health message, one is putting forward to say, "Well, there’s an enormous market share for immunisation", but that’s exactly what we’ve seen. We’ve seen the Federal Health Minister, Federal Government initiatives, to reward families and doctors for providing immunisation. That’s good public health."

<STRONG>Ray Moynihan: Industry-funded </STRONG>education programs have to walk a fine line, relying on company money but remaining independent in order to stay credible with GP’s.

Indeed, Ian Hickey’s Sphere program, has already won accolades from government and professional bodies.

But the balancing act becomes harder when it’s drug company rep’s doing the critical one-on-one sessions with G.P.s.

There do seem to be striking similarities in the colours and the imagery between some of the independently-generated educational materials for the GP’s desk, and company advertisements for Serzone, featured in the widely read Australian Doctor magazine.

Ray Moynihan: Is it appropriate to have similar images, if you like, similar images in the Serzone advertising, just small things, but similar icons and images that, that match the marketing strategies?

Professor Ian Hickey: "I think you’d have to give me examples of that because the images that we have developed, are quite separate. We share no…"

Ray Moynihan: No, but the images here, tell me if I’m wrong, but, we’re looking at similar, very small, but subtle reminders of the links here.

Professor Ian Hickey: "Ah, I guess you’d have to judge that one for yourself."

Ray Moynihan: Well, what do you think?

Professor Ian Hickey: "Well, I could tell you about the history of the background, is that actually the things that we had developed, we developed quite independently. We have no relationship with the advertising arm of the product."

Ray Moynihan There’s Spere and there’s Sphere...?

Professor Ian Hickey: "These were developed independently in time, to the particular thing. This existed first, my understanding of the particular thing. I mean, you could draw attention to it but, there’s no intention on our part to link the two particular products."

Ray Moynihan: Is it just a coincidence?

Professor Ian Hickey: "We had a set of logos originally that had a sphere, because Sphere is our name of our instrument. The name of the instrument goes back several years, precedes<STRONG> Serzone </STRONG>being available as an anti-depressant by some considerable period of time."

Professor David Henry: "Undoubtedly, some of the educational work that’s sponsored by industry is good but the sense is developing, that a very large proportion of the educational activities is actually being sponsored and has the brand of the industry on it."

Ray Moynihan: But doesn’t the independence of the doctors delivering the education help guard against that?

Professor David Henry: "It should do."

Ray Moynihan: Another area where companies are sponsoring the education of our doctors and the community, is osteoporosis, the thinning of the bones which happens as we age, making fractures more likely. And potentially, it’s a very big market for those offering treatment.

Dr David Eddy: Health Care Consultant
"Osteoporosis is a particularly alarming problem because the way it’s been defined, means that over half of everyone will eventually had the disease at some age in the future. So, we’ve defined this disease in a way that almost everyone gets it and if we link the need for a drug with the existence of a diagnosis, we’re going to have half the world on osteoporosis-related treatments. I don’t need to tell you the financial benefit of that to the drug companies that are selling the drugs. But it also, in the end, is going to cost people and government, and therefore tax payers, an awful lot of money and an awful lot of the people who might be considered appropriate for these drugs, in fact shouldn’t be getting them, so it would be an unnecessary and inappropriate use of the drug."
Ray Moynihan At the prestigious Garvan Institute in Sydney, medical scientists are busy working on new drug therapies for a range of common conditions.

Bone specialist, Professor John Eisman is particularly concerned about the under-recognition and poor treatment of osteoporosis. He’s one of the independent specialists, hired by drug companies to help raise awareness of the condition amongst the doctors and the wider community.

Professor John Eisman: Garvan Institute
"This is a very important issue, the question of conflict of interest and one that colleagues like myself, are very well aware of. The reality is, there is an enormous lack of education about major issues like osteoporosis in the community. We have some understanding of those issues and our interests in educating the public and the doctors, is similar to the interests of the companies for different reasons."

Ray Moynihan: But are diseases like osteoporosis, being promoted in order to help drug companies sell their product?

Professor John Eisman: "I have no doubt that companies will promote diseases for which they have a product. That makes sense for them but for osteoporosis, this is a disease that needs to be promoted, so that we can do much more to prevent the havoc that it causes in people as they age."

Professor David Henry: "If that awareness-raising has really been directed at the right group in the community and it’s been done in ways that is actually in the community’s interests, then no one can argue that it’s a good thing."

Ray Moynihan: Professor Henry sits on a committee advising the Federal Government on which new drug should attract public subsidies.

While he supports awareness-raising targeted at high risk groups, he’s concerned that the much more sinister possibility of disease-mongering.

Professor David Henry: "There’s an unfortunate possibility of an unholy alliance there, between the industry and some factions in the medical profession to create a disease that the notion of a disease, it’s almost disease-mongering, whereby people who are at the moment not in the health care system, can be brought in. Their problems can be medicalised, they can be turned into patients. The industry’s going to benefit and to some extent, the doctors and the investigators and the researchers are going to benefit but the question is, where is the benefit for the patient?"

Pat Clear: Australian Pharmaceutical Manufacturers Assoc.
"The underlying motive here, is to have the medicines used properly. I mean, let’s accept that that is one of the basic thrusts of a company."

Ray Moynihan: Isn’t there a danger though, that healthy people might be turned into patients as part of that, because of the very aggressive promotion?

Pat Clear: "Well, you’ve got to go through the scientific person, the doctor, before the prescription’s written, so I don’t think the patient who has no illness whatsoever, is going to receive a potent medicine."

Ray Moynihan: One of the new classes of drugs for osteoporosis, is called the bisphosphenates and the giant Merck Sharp and Dohme, are now aggressively promoting their new version, called Fosimax.

Ray Moynihan: One of their advisers is John Eisman. He’s highly enthusiastic about the new osteoporosis medications and their ability to reduce fractures.

Professor John Eisman: "There really has been an incredible improvement in the range of options that we have. Not only did we have hormone replacement therapy, which has been shown to be effective, there are now some selective oestrogens, they’re the active forms of Vitamin D, which are effective and there are also the bisphosphenates, the very potent ones, which have been shown now, in very well constructed studies, to essentially halve the risk of fracture."

Ray Moynihan: But saying the new drugs can have the risk of fracture, is really only half the story. Let’s say a woman has a two percent chance of developing a hip fracture and taking the drug continually for a number of years, reduces that risk to one percent. That is in relative terms, a 50% reduction in risk, which sounds very impressive. However in absolute terms, it’s really only a 1% reduction.

Ray Moynihan: Is there any sense that it’s misleading to use the relative risk reduction of say 50%, in advertising, when the absolute risk reductions can be much smaller than that?

Professor Graham Macdonald: Merke Sharp & Dohme
"The absolute risk reduction, applies to the population. For each individual, the real risk reduction is for them, is going to be the proportion of their risk, which is removed by treatment, i.e. 50%, say."

Ray Moynihan: So, it’s not misleading to use the 50% when the absolute is much smaller?

Professor Graham Macdonald: "I don’t believe it is for patients but I agree with you that doctors should know where this sits in the statistical range."

Professor David Henry: "If drugs are being promoted in younger patients who are not so high-risk, particularly women in the early post-menopausal phase, then you’re going to treat a very, very large number of women, in particular, and you’re going to expose them to the side-effects of treatment and a very small number are going to benefit. This is the concept of the number you need to treat and this may be in the hundreds, you may have to treat hundreds of younger women, so that one will have a fracture prevented and the benefits of that, the ratio of the benefits to the harm and the ratio of the benefits to the cost. have to be quite seriously questioned."

Ray Moynihan As with many conditions, there are non-drug solutions available.

Colleen Wilson Health Consultant
"I’ve been playing a modified netball/basketball game, which has been specially put together for probably the older adults, just to improve ball skills, coordination, flexibility, motivation. We’re trying to alleviate as much as we possibly can, the possibilities of people having falls and then fractures."
Professor John Eisman: "…Not only were vertical fractures but all the other osteo, peripheral osteo product fractures were reduced and importantly, hip fractures were reduced. They were halved."

Ray Moynihan: With so much industry sponsorship of education, is attention subtly shifted from non drug remedies?

And are the paid consultants helping companies to widen markets for new products?

Professor Graham Macdonald: "They don’t want to have their professional reputations compromised by any suggestion that they’re trying to win people over, changing clinical practice, on our lives. They’ve got their own agendas, obviously. We’re only a very small part of their professional lives, so, no, we’re not doing that."

Ray Moynihan: Aren’t those specialists though, some of them, paid consultants to your company, so don’t they in a sense, have a conflict of interest between serving you and being independent?

Professor Graham Macdonald: "The facetious answer is that we actually don’t pay them enough to do anything but I just come back to the fact that we’re a very small part of their lives. There, there’s, there’s, it’s not in their interest to compromise themselves for us."

Dr David Eddy: "I think it’s quite inappropriate for people to be actively and publicly promoting something if they’re receiving a fee from a drug company."

Ray Moynihan: Mathematician and medico, Dr David Eddy, is a former professor at Duke University, a regular contributor to leading medical journals and a strong advocate of the move to an evidence-based medicine.

These days he’s also consultant to a large private insurance company and he’s experienced, first-hand, the generosity of the pharmaceutical industry.

Dr David Eddy: "I think it’s very easy to fool ourselves into thinking we’re being independent, when in fact, we’re not and I’ll speak from personal experience. I was doing some work with a drug company and they didn’t pay me anything outright, however, they happened to hold the meetings in Nice, Geneva, Florence and New York City and they gave me a suite and five star hotels in each occasion. And I came away from that experience just kind of liking the drug company. I kind of, I just liked them, and I liked the people and I have to admit, it’s possible that, that could have swayed my recommendations.

So I did the following things. I required of myself, as a matter of principle, that anything I recommended, be backed up by the numbers. Second, if the numbers went against the drug, I would continue to say that. Third, I wouldn’t accept suites in five star hotels as a compensation, if you will, for doing work with a drug company."

Ray Moynihan: Non-drug solutions occasionally receive backing from industry education grants. But they only a fraction of the promotional energy put into medications.

Dr Paul Glasziou GP, University of Queensland
"I suppose the problem is the lack of balance, that there is no group of people who go about talking about the non-pharmaceutical alternatives to things because it’s not worth selling."

Ray Moynihan: Part of establishing that balance, is taking a close look at whether drug solutions are really necessary. For example, one of the more common prescriptions in Australia, is for antibiotics to treat acute ear infection in children. But after a close look at the scientific evidence, Dr Paul Glasziou has found in most cases, the antibiotics may not be needed.

Consultation between Dr Paul Glasziou and "Gemma’s Mum"

Dr Glasziou: "…We saw Gemma, what was it, about two weeks ago now, with that ear problem and we’d said that she needed a lot of Panadol for that and I gave, given you the script for antibiotics in case it was getting worse."

"Yes."
Dr Glasziou: "Um, you were going to use them on the weekend if it was getting worse. So what happened after that?"

"Well, we didn’t use the antibiotics at all. We just gave her lots of Panadol and she had lots of sleep and she seemed quite fine after that."

Dr Glasziou: "Okay."

"Which was great."

Dr Glasziou: "Yep, okay, so as I’ve explained, that’s the sort of, the usual course, is that most kids would be better within about twenty-four hours."

Dr Glasziou: "Okay. But there’s sometimes it goes on for a while and they occasionally do need the antibiotics, which is why I left you with this script."

Dr Paul Glasziou: "We’re the highest prescribers of antibiotics for middle ear infections in the world. I would say, the clear majority of prescribing for middle ear infections, is unnecessary."

Ray Moynihan: But isn’t it better to be safe rather than sorry?

Dr Paul Glasziou: "It’s better to be safe when they’re really needed but a lot of people get side-effects, common ones being things like diahhorea or nausea or even vomiting from it and occasionally, there are very severe reactions."

<STRONG>Ray Moynihan: There is an alternative to drug company reps visiting doctors. With funding from the Federal Government, a team of Adelaide pharmacists, is trying to get balanced information to local GPs about both the risks and benefits of drugs</STRONG>.

In order to try and measure whether their service has any influence, a study is under way in Adelaide, comparing prescribing in areas where the team visits and areas where it doesn’t. Results have been positive.

For example, there are indications that prescribing of the potentially harmful anti-inflammatories, have fallen significantly in the target area and even more important, hospitals are reporting less stomach bleeds.

Dr Elizabeth Crawley: Adelaide GP
"It’s a very useful service. The staff come around and talk to us about a range of drugs and a range of drug issues and we get a very unbiased view and that’s been very useful, not only with their printed information that they leave with us but also, they have a phone service where we can ring, ask questions about drug interactions or some other problems and they’ll get back to us, either straightaway with an answer on the phone or research the topic and then send us some very good, very detailed information, which we can either share with the patient or use for making a decision."

Ray Moynihan: With companies orchestrating so much of what our doctors see and hear, there’s a real danger we are over-medicalising and over-medicating too many relatively healthy people.

It may be time to move away from the<STRONG> carnival of commercial excess </STRONG>towards more of a rational celebration of the power and the grace of the human body."
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Joined: January 1st, 1970, 12:00 am

August 17th, 2007, 10:23 am #6


<EM>Ray Moynihan: Without wanting to play down for a minute the legitimate severe mental illness out there, <STRONG>aren’t you, by saying things like that, by publicising such huge estimates, helping build a very large market for those selling cures</STRONG>?</EM>

<EM>Professor Ian Hickey: <STRONG>"Yes, I don’t see that as a problem at all.</STRONG></EM>
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Joined: January 1st, 1970, 12:00 am

August 17th, 2007, 10:29 am #7


<EM>Ray Moynihan: Is it appropriate to have similar images, if you like, similar images in the Serzone advertising, just small things, but similar icons and images that, that match the marketing strategies?</EM>

<EM>Professor Ian Hickey: "I think you’d have to give me examples of that because the images that we have developed, are quite separate. We share no…"</EM>

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http://www.mentalhealth.com/drug/p30-n05.html


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<TD class=whs2 width="90%"><FONT style="FONT-SIZE: x-large; COLOR: #ff0000" color=#ff0000 size=6><A name=Top></A>Nefazodone</FONT>
<FONT style="COLOR: #ff0000" color=#ff0000>Brand name: Serzone</FONT></TD>
<TD vAlign=center align=middle width="10%"><IMG height=120 src="http://www.mentalhealth.com/circlehead.gif" width=123 border=0>
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<H3 style="TEXT-ALIGN: center" align=center><FONT style="COLOR: #ff0000" color=#ff0000>Important News: Discontinuation of Sales of Nefazodone (Serzone)</FONT></H3>
<P style="TEXT-ALIGN: justify">On 10/02/2003 Bristol-Myers Squibb announced: "It has come to the attention of Health Canada that nefazodone (Serzone) has been associated with adverse hepatic events including liver failure requiring transplantation in Canada. Following discussions with Health Canada, Bristol-Myers Squibb Canada has decided to discontinue sales of nefazodone, effective November 27, 2003.". <!--(HR)============================================================-->
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Joined: January 1st, 1970, 12:00 am

August 17th, 2007, 10:36 am #8


by industry psychiatrists who know very well what the drugs do.

Of&nbsp;course he's from a university AND he knows that industry needs Key Opinion Leaders such as professors without ethics, as they are the ones who most successfully spread the promotion of diseases and&nbsp; drugs - they are the ones who&nbsp;spread the&nbsp;malignancy.
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Joined: January 1st, 1970, 12:00 am

August 17th, 2007, 10:43 am #9


country has them.&nbsp; Set up to promote disease and to promote drugs for disease.

Traitors to science, traitors to patients.

&nbsp;

<STRONG>Of course he has no problem helping build a large market for drug makers</STRONG>.

<STRONG>Thats his life's work.</STRONG>
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Joined: January 1st, 1970, 12:00 am

August 17th, 2007, 12:05 pm #10


<STRONG>Which is why you'll find her spouting the industry line whenever she can find the professional version (like Hickie)&nbsp;spouting the industry line.</STRONG>

Greed corrupts, power corrupts, and Marjorie wants to be&nbsp;right up there -&nbsp;at the top, alongside the Industry Influenced, Disease & Drug&nbsp;Spreader,&nbsp;Stars.&nbsp;

&nbsp;

Work Hard Marjorie, there's plenty more fame, pharma gifts, grants and funding to be had and, just like the 'real' Key&nbsp;Opinion Leaders, we know <STRONG>YOU WANT IT ALL</STRONG>.&nbsp;

<STRONG><FONT size=4>MUSIC POSTED IS DEDICATED TO MARJORIE WALLACE, IAN HICKIE, DAVID SCHAFFER&nbsp;</FONT></STRONG>

<STRONG><FONT size=4>and the rest of&nbsp;a&nbsp;long list of those in the&nbsp;scientific, professional, drug industry, regulatory fields&nbsp;and 'front groups' who&nbsp;put their own interests before the health and safety of others.</FONT></STRONG>

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