Glaxo denies disease mongering_Selling Bipolar questioned_PLoS

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[sSRI-Research] Glaxo denies " disease mongering " _Selling

Bipolar questioned_PLoS

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

Since at least 2002, critics--including the director of the prestigious

Cochrane Center, Dr. Peter C Gøtzsche--have been grappling with the notion

that medicine has been derailed from its rightful mission of treating

illness and expanding under the influence of pharmaceutical companies to

engage in " disease mongering. "

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 Henderson, April 11, 2006:

 

Richard 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.

 

" GlaxoSmithKline, 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, David 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 Richard 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

 

Richard 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. David 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

212-595-8974

veracare

 

http://medicine.plosjournals.org/perlserv/?request==read-response & doi=.1371/jou\

rnal.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: GlaxoSmithKline, Pfizer; speakers

bureaus:

GlaxoSmithKline, Abbott Laboratories; advisory boards: GlaxoSmithKline,

Pfizer.

 

Submitted 26 April 2006 Published: 26 April 2006

 

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

friend

and colleague David 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

David 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, SmithKline 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 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. David Menkes at Conference on Disease Mongering, Newcastle, Australia

2006.

 

 

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