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http://www.ahrp.org/cms/content/view/154/29/

Glaxo denies " disease mongering " _Selling Bipolar

questioned_PLoS

Friday, 28 April 2006

Under the influence of pharmaceutical companies, physicians anhd drug

companies engage in " disease mongering. " Below is a critique of Dr.

Healy's essay: Dr. Nassir Ghaemi who argues for the legitimacy

of bipolar diagnosis. Since at least 2002, critics--including the

director of the prestigious Cochrane Center, Dr. C Gøtzsche--

have been grappling with the notion that medicine has been derailed

from its rightful mission of treating illness.

http://bmj.bmjjournals.com/cgi/content/full/324/7342/886

" Disease-mongering turns healthy people into patients, wastes

precious resources and causes iatrogenic (medically induced) harm.

Like the marketing strategies that drive it, disease-mongering poses

a global challenge to those interested in public health, demanding in

turn a global response. " See, special issue of PLoS Medicine (Pubic

Library of Science): http://collections.plos.org/diseasemongering-

2006.php

" Selling Sickness " by Ray Moynihan and Alan Cassels, followed by the

Australian conference (April 11-13), " Disease Mongering, " accompanied

by a special issue of PLoS, have elevated the discussion. Three

recent UK press reports address different aspects of the issue:

1. The Times World News: " Drugs companies 'inventing diseases to

boost their profits' by Mark , April 11, 2006:

Ley, of the Association of the British Pharmaceutical

Industry, rejected the accusations, pointing out that Britain has

firm safeguards against disease-mongering. Many of the authors'

criticisms, he said, were aimed squarely at countries such as the

United States, where pharmaceuticals can be openly advertised

directly to patients. " Drug companies are not allowed to communicate

directly with patients, and we do not invent diseases, " he said.

http://www.timesonline.co.uk/article/0,,3-2128371,00.html

2. Guardian: " Glaxo Denies Pushing `Lifestyle' Treatments " by Fiona

Walsh Friday April 28, 2006.

" GlaxoKline, Europe's biggest drugs manufacturer, yesterday

defended itself against accusations that it is turning healthy people

into patients by " disease mongering " and pushing " lifestyle "

treatments for little-known ailments. " The head of GSK's

pharmaceutical operations, Stout, denied the accusations,

saying: " Things like restless leg syndrome can ruin people's

lives…. " http://business.guardian.co.uk/story/0,,1763199,00.html

3. Guardian: " Depression is UK's Biggest Social Problem, Government

Told " by Sara Boswell, April 18, 2006.

Lord Layard, emeritus professor, London School of Economics,

has an article in the BMJ in which he claims around 15% of the

population suffers from depression or anxiety. He notes that the

economic cost in terms of lost productivity is huge - around £17bn,

or 1.5% of UK gross domestic product. " There are now more than 1

million mentally ill people receiving incapacity benefits - more than

the total number of unemployed people receiving unemployment

benefits. " http://society.guardian.co.uk/print/0,,329467273-

106049,00.html

Layard--as well as the National Institute for Clinical

Excellence (Nice)--advises that drugs are not the best answer. " He

estimates that around 800,000 patients a year would require cognitive

behaviour therapy. That means the country needs an extra 10,000

therapists. "

That should make psychotherapists ecstatic!

However, since the focus in mental health for the last several

decades has been on drugs alone, there have been no controlled

studies documenting the effectiveness of psychotherapy compared to

the effect of a sympathetic listener. Nevertheless, it is reasonable

to assume that a even an incompetent therapist would do less harm

than toxic drugs whose hazardous effects ARE documented.

The secret to the pharmaceutical industry's staggering success until

now may be found in the comment by GSK chief executive, Jean-Pierre

Garnier: " Our eyes are open to all opportunities. "

4. PLoS Medicine, like the BMJ online, has a commendable open

commentary policy, and publishes responses to its articles almost the

instant they are received. PLoS also is to be commended for requiring

authors—including letter writers—to disclose funding sources for

possible conflicts of interest.

Below is a critique of Dr. Healy's essay, " The Latest Mania:

Selling Bipolar Disorder, " ( See: PLoS Med 3(4): e185) by Dr. Nassir

Ghaemi who argues for the legitimacy of bipolar diagnosis citing oft

repeated misinformation about the ancient history and prevalence of

bipolar disorder, and claiming the existence of " much larger

empirical evidence that bipolar disorder has been highly

underdiagnosed (rather than the minimal empirical evidence that it is

overdiagnosed). "

Dr. Ghaemi's critique is followed by Dr. Healy's response corrects

the historical facts, amplifying the points made in his original

essay, pointing out: " If bipolar disorder could be clearly traced

back to the Greeks, the fact that American physicians so rarely made

the diagnosis before 1970 and the introduction of lithium to the USA

is hard to explain. "

Contact: Vera Hassner Sharav

veracare@... veracare@... This email address is being

protected from spam bots, you need Javascript enabled to view it

http://medicine.plosjournals.org/perlserv/?request=read-

response & doi=10.1371/journal.pmed.0030185

The newest mania: seeing disease mongering everywhere

S. Nassir Ghaemi, Director, Bipolar Disorder Research Program and

Associate Professor of Psychiatry and Public Health, Emory

University, Atlanta, GA, United States of America E-mail

Competing Interests: I wish to disclose the following current

affiliations or involvement: research grants: GlaxoKline,

Pfizer; speakers bureaus: GlaxoKline, Abbott Laboratories;

advisory boards: GlaxoKline, Pfizer.

Submitted Date: 26 April 2006 Published: 26 April 2006

I feel compelled to comment on your article on bipolar disorder by my

friend and colleague Healy. I respect Dr. Healy both as a

historian of psychopharmacology and psychiatry, and as a

psychopharmacology researcher. I have been impressed by his

historical scholarship over the years in bringing out the economic

and social aspects of the rise of psychopharmacology. I think his

specific critiques about the likely overuse of antidepressants in the

West in recent years, as well as the influence of the pharmaceutical

industry, have been valid in many respects. I also find the special

issue on disease mongering not unconvincing, especially as it relates

to new potential diagnoses like adult ADHD. Yet I must take exception

to the inclusion of bipolar disorder with such new-fangled entities.

Mania and melancholia have been well described since antiquity, and

the current notions about the diagnosis of bipolar disorder (even the

broader notions of the " bipolar spectrum " ) are fully present in the

writings of Esquirol and Kraepelin. It seems highly unlikely that

they were markedly influenced by the pharmaceutical industry. To

accept the drift of this special issue, one would have to suppose

that Arataeus of Cappadocia was heavily influenced by pharmaceutical

marketing in the second century AD.

Of course, the possibility of overdiagnosis of bipolar disorder

exists, often influenced by the pharmaceutical industry, but this in

no way means that the diagnosis itself is invalid, nor does it

counteract the much larger empirical evidence that bipolar disorder

has been highly underdiagnosed (rather than the minimal empirical

evidence that it is overdiagnosed) in the antidepressant era (1). Dr

Healy seems to emphasize the issue in children, where indeed more

uncertainty exists, but the overall impression of the article does

not do justice to the reality that this illness has a long history of

description and much more evidence of nosological validity (based on

description, genetics, course and biological data) (2) than such

newcomers as adult ADHD and restless legs syndrome. Perhaps we should

be on the lookout for the newest mania: seeing disease mongering

everywhere.

1. Ghaemi SN, Ko JY, Goodwin FK. " Cade's disease " and beyond:

misdiagnosis, antidepressant use, and a proposed definition for

bipolar spectrum disorder. Can J Psychiatry. 2002 Mar;47(2):125-34.

2. E Robins, SB Guze. Establishment of diagnostic validity in

psychiatric illness: its application to schizophrenia. Am J

Psychiatry. 1970 Jan;126(7):983-7.

~~~~~~~~

The Best Hysterias: Author's Response to Nassir Ghaemi

Healy, Director, North Wales Department of Psychological

Medicine, Cardiff University, Cardiff, Wales, United Kingdom, E-mail

Competing Interests: DH has been a speaker, consultant, or clinical

trialist for Lilly, Janssen, Kline Beecham, Pfizer, Astra-

Zeneca, Lorex-Synthelabo, Lundbeck, Organon, Pierre-Fabre, Roche, and

Sanofi. He has also been an expert witness in ten legal cases

involving antidepressants and suicide or homicide and one case

involving the patent on olanzapine (Zyprexa). None of these interests

played any part in the submission or preparation of this paper.

Submitted Date: 27 April 2006 Published: 27 April 2006

Nassir Ghaemi has helped raise the profile of this truly debilitating

disorder. This response trades on his respect for my historical

scholarship. First mental disease entities are a recent construct. No

disease resembling bipolar disorder was described before 1854 in

Paris - and the links between folie circulaire described then and

modern bipolar disorder are tenuous. Second, for the Greeks mania

referred to any overactive insanity, and melancholia to any

underactive state. The majority of manias were probably delirious

states. The melancholias may have been anything from Parkinson's

disease to hypothyroidism. Third, Emil Kraepelin's manic-depressive

insanity (1899) was a very different disorder to bipolar disorder,

which only appears in the late 1960s. If bipolar disorder could be

clearly traced back to the Greeks, the fact that American physicians

so rarely made the diagnosis before 1970 and the introduction of

lithium to the USA is hard to explain. Kraepelin's likely response to

recent proposals that we recognize and distinguish between bipolar 1,

2, 2.5, 3, 3.5, 4, 5, 6 and bipolar spectrum disorders would probably

not be printable.

Disease mongering is not the creation of diseases de novo - as in the

restless leg syndrome Dr Ghaemi cites, descriptions of which go back

to antiquity. Disease mongering is where the interests of the seller

of a nostrum, who sells by emphasizing the existence of and risks of

some condition, in fact outweigh the likely benefits from the

proposed remedy to those affected by the putative condition (1). It

shades into hucksterism and it was associated with Harley Street long

before modern pharmaceutical companies. But companies now bring an

industrial efficiency to this practice, and where physicians were

once a bulwark of scepticism against any trading on credulousness, we

are now the most cost-effective marketing tool companies have.

Mongering applies to conditions from mild elevations of blood

pressure or lipids, or bone thinning. No one argues hypertension or

hypercholesterolemia are not real or that in malignant cases these

conditions do not constitute valid targets of treatment. But

malignant cases are rare. In cases that are not malignant, when the

likely intervention is with a toxic compound rather than a proposed

alteration of lifestyle, there is or should be a boundary.

Psychiatry was once plagued by " boundary violations " , where

physicians exploited the dependence of their patients. All the

indications are that we are now in a new era of drug-related boundary

violations. There is perhaps nowhere in medicine where this is more

obvious than in the case of bipolar disorders, with adults treated

with bizarre cocktails and children put on some of the most lethal

drugs in medicine.

Making it clear that the term mood-stabilizer is itself an advert and

that the notion of bipolar disorder can be viewed as an instance of

rebranding does not deny the reality of anything. The key concerns

are not reality in this sense, but rather when to treat. As the

history of hysteria shows, the best pseudo-convulsions come from

patients with a convulsive disorder. The most realistic somatization

from patients with other real disorders. Patients conform their

presentations to the interests of their doctors. Drug companies know

this. Patients deserve physicians alert to such possibilities. In the

current welter of bipolar presentations, one worry is that patients

with severe manic-depressive disorder will lose out. Another is that

research on this most difficult of disorders will be invalidated by a

dilution by patients with other problems. A final worry is that when

the marketing caravan moves on, manic-depressive illness will be left

once more under-resourced and researchers will have one less lever to

pull as they have " had their chance " .

References

1. Menkes at Conference on Disease Mongering, Newcastle,

Australia 2006.

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