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.tim
esonline.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://busines
s.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, bond
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 ahrp.org
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: GlaxoSmithKline,
Pfizer; speakers bureaus:
GlaxoSmithKline, Abbott Laboratories; advisory
boards: GlaxoSmithKline,
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 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 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. David Menkes at Conference on Disease
Mongering, Newcastle, Australia
2006.
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