Selling sickness: the pharmaceutical industry and disease mongeringCommentary: Medicalisation of risk factors
BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7342.886 (Published 13 April 2002) Cite this as: BMJ 2002;324:886
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for every ill there is a ready made answer in form of a pill.the
number of pills an average person consumes is astounding.it also shows how
convinced patients are of their "efficacy". the pharmaceutical companies
have a lot of vested interests in promoting this trend. recently, i have
come across an advertisement suggesting that taking statins is as good as
aspirins for ihd.
i think the article by moynihan et al was very comprehensive and timely.
but whether it will open eyes and ears in relevant quarters is to be seen.
manan
Competing interests: No competing interests
I think that there are many complex problems mixed in the article of
R.Moynihan et al. and in the responses.
There is a general trend to globalisation in industry systems ,but also in
science and research groups.
There is also a tendency to intensify cooperations between universities
and industry in Europe (not only triggered by politics).
Different interests of industry,politics and physicians (psychiatrists)are
normal,these conflicts(for example costs and dependency) are complex but
interdependent,and are solved in a fair way.The individual patient and his
optimal (psychopharmacological) treatment must become the mean point of
interest.
The relevance of independent drug surveillance studies is great, for
example the AMSP project in Germany,Switzerland and Austia with a
continous drug monitoring of patients with psychopharmacological drug
treatment(severe adverse dug reactions).
D.Degner,M.D.
Competing interests: No competing interests
The recent article by Moynihan et al (1) raises a number
of important issues certainly worthy of appropriate
debate. It is a pity therefore that Mr Moynihan, a
journalist, decided to follow a rule well known in his
profession namely “don’t let the facts get in the way of a
good story” in this article. The British Medical Journal
has been a strong proponent of evidence based
medicine, but this article is anything but evidence
based.
For example, with respect to Osteoporosis the authors’
make a number of incorrect assertions and are very
selective in citing the literature. Osteoporosis Australia
is not a medical foundation but an independent patient
group originally conceived by the Arthritis Foundation of
Australia, but now evolved into a separate charity to
promote the cause of patients with osteoporosis. It
has received funding from pharmaceutical companies,
but also from the Federal and State Government and
other sources. The one minute risk test developed by
the International Osteoporosis Foundation refers to
women with an early menopause before age 45, not
“any menopausal woman” as the authors incorrectly
imply and does not state that a single risk factor is
sufficient to justify bone density testing. Rather it
states that the patient should take the whole checklist
along to their general practitioner for discussion about
the need for whether further tests are necessary.
The authors express concern that pharmaceutical
companies often fund meetings where the “disease
was being defined”. Importantly, the authors’ would
have been aware when writing their document, that
Osteoporosis Australia and the National Prescribing
Service convened a Fracture Summit in Melbourne in
2001 which included representatives of the
Pharmaceutical Benefits Advisory Committee on the
panel to look at the magnitude of the problem of
osteoporosis using an evidence based approach.
Osteoporosis Australia and the National Prescribing
Service specifically excluded funding of the meeting by
the pharmaceutical industry. The outcome of this
meeting, recently published (2), concluded there was
no RCT evidence to support what the authors’ suggest
are moderately effectively non-pharmacological
strategies such as weight bearing exercise. The
Summit does however make recommendations about
dietary calcium supplementation and vitamin D.
In regard to bone density, again the authors’ are
selective in their reporting. Bone density is widely
accepted as the best predictor of future fracture risk.
The article by Wilkin (3) quoted by the authors to
suggest that bone density is not a sufficiently accurately
predictor of an individual’s risk of fracture was also
accompanied by an expert commentary that challenged
his conclusions (4), but the authors’ failed to cite this
counter view. The authors also suggest there is
promotion of inappropriate bone density testing. Our
Fracture Summit rather concluded that screening of
unselected populations is not recommended by any
authoritative group in the field (2).
It seems the authors’ would have sufferers of
Osteoporosis, who sustain hip fractures, kyphosis or
reduced quality of life, be reassured that they don’t have
a real disease just a risk factor, low bone mass.
Whilst we accept the role of education and debate, the
overall tone of this article is inappropriate. Much of
what the authors have to say comes from
“conversations with industry insiders” and numerous
so called “personal communications”. This is not
evidence, but rather hearsay. It is written in tabloid
style and perhaps that is where it should have been
published. Rational debate is to be encouraged but
selective reporting by authors’ with agendas is
inappropriate.
Yours sincerely,
Philip N Sambrook
Medical Director
Judy Stenmark
CEO
Osteoporosis Australia
References
(1) Moynihan R, Heath I, Henry D, Selling sickness: the
pharmaceutical industry and disease mongering, BMJ,
2002, 324, 886-891
(2) Preventing osteoporosis: outcomes of the
Australian Fracture Prevention Summit, Med J Aust,
2002, 176, S1-S16
(3) Wilkin TJ, Changing perceptions in osteoporosis,
BMJ, 1999, 318, 862-864
(4) Eastell R, Commentary: Bone density can be used
to assess fracture risk, BMJ, 1999, 318, 864-865
Competing interests: No competing interests
Editor,
Moynihan et al (1) have been given a great opportunity by your editorial
team to illustrate the parlous state of current biomedical practice.
Instead of grasping the nettle they have gone for the easy targets: the
fringe illnesses we all of us see day in day out and to which we respond
with concern and understanding, but in general, not with drugs.
They argue that we are complicit in the construction of illness on the
fringes; that in some way we are adding to the disease pantheon.
This may be true and I would be the first to highlight the construction of
disease for the benefit of multinational interest (2), but as inferred
earlier they miss the point.
What about cardiovascular disease, respiratory disease, gastrointestinal
disease and psychiatric illness?
Why not draw attention to the pharmaceutical industry's heist of
mainstream practice?
Answer: Too risky.
The BMJ is a mainstream rag overseen by an editorial board that
consistently fails to encourage discussion of key issues.
Jim Hardy, 60 Florida Street, London E2 6LL
(1) R Moynihan, I Heath, D Henry, P Gotzsche.Selling sickness:the
pharmaceutic industry and disease mongering. BMJ:324:886-891. No 7342 13
April 2002.
(2) J Hardy. Doctors are part of an economic hegemony. BMJ 2001; 322:439.
19.2.2001
Competing interests: No competing interests
Dear Sir
The suggestion that pharmaceutical companies sponsor diseases so that
they can then promote them to prescribers and customers (Moynihan et al,
“Selling sickness: the pharmaceutical industry and disease mongering”)
appears on analysis to emerge as the fact that pharmaceutical companies
are actively involved in sponsoring the definition of diseases.
If so, this is true. Both the pharmaceutical industry and regulatory
authorities that license new medicines need to develop closely-defined
definitions so that the safety and efficacy of new medicines can be
properly measured. However in real-life situations prescribers do not
always adhere to the licensed indications when prescribing.
There is no doubt that, rather than over medicalising, there is in
fact a need for more medicalisation as indicated by Ebrahim , and
Bonaccorso and Sturchio and highlighted by Moynihan and Smith in their
editorial “Too much medicine?” The rise of guideline led care around the
Western world demonstrates the fact that far too many serious diseases are
underdiagnosed and undertreated. Failure to put evidence-based medicine
into practice is quite legitimately addressed by the pharmaceutical
industry which has developed medicines which are preventative, curative or
alleviate many important conditions. Examples include the under use of
statins in the UK, the delay in the uptake of thrombolysins in the 1980s
and reliance on old psychotropics when newer medicines have a much more
favourable side effect profile.
Of course, disease awareness campaigns are likely to expand the
market for medicines in that area, but it will be for competitor products
as well as those of the sponsoring company. However the real value of
disease awareness campaigns is exactly what it says: making consumers
aware that treatment may be available for their condition. Many patients
live in stoical ignorance that something can be done to improve their
quality of life and, not infrequently, major pathology is detected as a
result of a patient seeking medical advice following contact with a
disease awareness campaign.
Moynihan appears to suggest that preventative medicine is threatening
the viability of publicly funded healthcare systems. Yet clearly, it is
far better to prevent disease than to treat it when it is established.
The benefits of stopping smoking, treating hypertension, reducing raised
blood lipids etc are all well established but could not be done without
the assistance of the pharmaceutical industry.
In choosing the diseases that Moynihan et al detail as sponsored by
the pharmaceutical industry, it is unfortunate that the Australian
experience has been highlighted. In the UK, when MSD launched Propecia
for male pattern baldness, it deliberately chose to do so with the
medicine available on private prescription only so that it would not be a
drain on the NHS. In Europe, patients cannot be targeted with promotional
material and all promotional material for health professionals in the UK
has to comply with the ABPI Code of Practice and be signed off by the
company medical department. Moynihan’s article would suggest that
osteoporosis has been effectively sponsored by the pharmaceutical
industry. In fact, far too many people who fall and develop a fracture
are not considered for treatment for osteoporosis. Consumers should be
informed that fractures in later life may be due to osteoporosis and that
there are methods of treatment, of which medicines are just one group.
Sheila McKechnie from the Consumers’ Association claims that all
available evidence of direct to consumer advertising shows that this will
bring about far-reaching and extremely negative consequences for public
health throughout the EU. This is fundamentally untrue and, indeed, there
is published evidence to show that patient compliance and understanding of
disease is improved following DTCA . However this is not really relevant,
as the pharmaceutical industry has no current plans to seek this ability
to advertise to the general public, although a relaxation of laws on the
provision of information would be welcome.
In conclusion, the pharmaceutical industry is not inventing disease
but rather working hard to develop new, innovative medicines for the
overall benefit of mankind.
Yours sincerely
Richard Tiner
(Dr Richard Tiner,
Medical Director,
Association of the British Pharmaceutical Industry,
12 Whitehall,
London SW1A 2DY,
Email: rtiner@abpi.org.uk)
Competing interests: No competing interests
Editor.
We attended a meeting on Diabetes Mellitus and Coronary Heart Disease
organised by the Lanarkshire Health Care Committe with Post Graduate
Education Allowance accreditation and sponsored by Novartis. The meeting
was aimed at the Primary Care Team involved in Chronic Disease Management.
One of the statements made at the meeting was that high post-prandial
Glucose concentrations double the risk of death in Diabetics.We questioned
this statement and asked to see evidence for this claim, and the following
day were presented with the DECODE study (1) by the Novartis
representative.
The DECODE study is a meta-analysis from 13 prospective European
cohort studies looking at the relationship between Glucose Tolerance and
mortality. The aim of the study was to compare the Oral Glucose Tolerance
Test with the Fasting Glucose Levels as diagnostic tools for Diabetes
Mellitus and Glucose intolerance and predictors of mortality in the
European Population. The study found that mortality is significantly
related to high Glucose concentrations 2 hours after a Glucose load (the
Oral Glucose Tolerance Test) independently of Fasting Glucose Levels. This
is a particularly important finding in that current guidelines led by the
American Diabetes Association are putting more emphasis on Fasting Glucose
Levels as a screening tool for diagnosing Diabetes Mellitus in preference
to the Oral Glucose Tolerance Test. The study concludes that the Oral
Glucose Tolerance Test is more sensitive than the Fasting Glucose Level at
identifying people with impaired Glucose tolerance and Diabetes, for which
there are effective, evidence-based interventions known to reduce
morbidity and mortality.
Summary of results 31% of Diabetics as identified by the Oral Glucose Tolerance Test had normal Fasting Glucose concentrations. glucose(mmol/l) mortality rates fasting blood glucose > 7 16% normal fasting glucose: 2 hour OGTT > 11.1 15% normal fasting glucose: 2 hour OGTT 7.8-11.1 12% normal glycemic fasting and at 2 hours 6.4%
The meeting used the DECODE study as a major source of evidence in
changing clinical practice, i.e. managing post-prandial Glucose Levels in
Diabetic patients.The DECODE study does not investigate whether reducing
post-prandial Glucose concentrations reduces mortality in Diabetics, in
fact it does not look into the treatment of Diabetes, but is an
investigation into the diagnosis of Diabetes in an unscreened population.
This is a fundamental misinterpretation of the DECODE study and we believe
is driven by a deceptive analysis by Novartis, who quote the study in
their literature (2), implying that it suggests the mortality rate in
Diabetics can be reduced by reducing post-prandial Glucose Levels.The
DECODE study is the only study mentioned in the Novartis literature, apart
from small print references at the end of the pamphlet.
The irony of this is that the speaker emphasised the Fasting Glucose
Level as the important screening tool in Diabetes, in preference to the
Oral Glucose Tolerance Test.
Should drug companies be allowed to indiscrimately use notable papers,
which practitioners have often heard of, but not always read, in support
of their products, thus gold-stamping them ?
Novartis have invented a disease, high post-prandial Glucose
concentration in Diabetic Patients, and come up with a product,
nateglinide, a short acting B-cell stimulant to be taken with meals,
reducing post-prandial Glucose spikes, and by inference, reducing
mortality in Diabetic patients. Nateglinide costs about 4 times more than
gliclazide.
(1)DECODE study group. Glucose Tolerance and Mortality : comparison of WHO
and American Diabetic Association critera. Lancet, 1999 ; 354 : 617-621.
(2)Leaflet by Novartis advertising STARLIX : Clarity and Control in Type 2
Diabetes.
Robert Flowerdew and Sinclair Scott,
General Practitioners, Douglas, 69 Ayr Road, Douglas, Lanarkshire, ML11
0PX.
LAUREFLOWERDEW@aol.com
Competing interests: Summary of results 31% of Diabetics as identified by the Oral Glucose Tolerance Test had normal Fasting Glucose concentrations.glucose(mmol/l) mortality ratesfasting blood glucose > 7 16%normal fasting glucose: 2 hour OGTT > 11.1 15%normal fasting glucose: 2 hour OGTT 7.8-11.1 12%normal glycemic fasting and at 2 hours 6.4%
EDITOR- Moynihan et al.'s article on disease-mongering by the
pharmaceutical industry (1) reminded us of an old Bronx baseball saying,
originating with Yogi Berra: "It's deja vu all over again." 3M has for
years sponsored the 3M/National Vaginitis Association
(www.vaginalinfections.com). The 3M/NVA produces a newsletter for health
professionals (The Vaginitis Report) and materials for patients. Like the
groups described by Moynihan et. al., the 3M/NVA is ostensibly an
educational resource run by health professionals. Unfortunately, its
activities involve a large element of disease-mongering. Mild symptoms
are offered as portents of serious disease and doctors are encouraged to
be aggressive in their attempts to diagnose and treat vaginal infections,
specifically bacterial vaginosis. As luck would have it, 3M produces a
drug that treats bacterial vaginosis. More recently, the 3M/NVA
established a toll-free number to distribute a free “educational brochure”
promoted by TV personality Deborah Norville.
The Association provides a further example of what Moynihan describes
as using statistics to "maximise the size of a medical problem." An
Association-sponsored survey found "that one-third of women believe that
vaginal odor is normal, and approximately 24% believe that it's normal to
experience vaginal itching". (2) This is offered as evidence of women’s
"lack of knowledge" regarding vaginal health. The Association website
encourages women to contact a health-care provider when they experience
such symptoms. In fact, there is good evidence from the primary
literature that both odor and itching frequently occur in normal women.
(3;4)
The model of vaginal complaints as due to infectious agents has been
heavily promoted by 3M though the Association and is implicit in the very
naming of their website which refers to vaginal “infections”. Yet we know
that many women with vaginal complaints do not have an identifiable
infectious pathogen. (5) It is time for clinicians to rethink the almost
reflexive response, encouraged by the pharmaceutical industry and its
front groups, of reaching for the prescription pad when a patient presents
with vaginal complaints. As Yogi Berra once said: “You can observe a lot
just by watching.”
Matthew Anderson, MD & Alison Karasz, Ph.D.
Assistant Professors
Department of Family Medicine and Community Health,
Albert Einstein College of Medicine
Peter Lurie, MD, MPH
Public Citizen’s Health Research Group
No competing Interest
Corresponding Author: Matthew Anderson, MD,
Email: andersonma@aol.com,
Montefiore Family Health Center,
360 E. 193rd St.
Bronx, N.Y., 10458,
USA
Reference List
(1) Moynihan R, Heath I, Henry D. Selling sickness: the
pharmaceutical industry and disease mongering. British Medical Journal
2002; 324:886-891.
(2) National survey reveals most women still are unaware of
bacterial vaginosis (BV), the most common vaginal infection. 3M/National
Vaginitis Association . 2002. 2-21-2002.
(3) Doty RL, Huggins GR. Changes in the intensity and pleasantness
of human vaginal odors during the menstrual cycle. Science 1975; 190:1316-
1318.
(4) Priestley C, Jones B, Dhar J, Goodwin L. What is normal vaginal
flora? Genitourinary Med 1997; 73:23-28.
(5) Centers for Disease Control and Prevention. Guidelines for
treatment of sexually transmitted diseases. MMWR 1998; 47(RR-1).
Competing interests: No competing interests
Anyone who takes the time to examine the actual evidence can
see that the manufacturing of "treatable diseases" has
become a vital part of conventional medical practice.
Hep C is a pefect example of how prefabricated correlations,
dubious surrogate markers and sensational estimates are
passed off as scientific proofs.
I ask in all seriousness, can anyone provide a single
scientific citation for an electron micrograph of purified
hep C? In lieu of a gold standard one has to wonder just how
the tests for hep C have been validated!
Clearly the media terrorism will sell drugs and millions of
otherwise healthy people, who happen to test positive on
these bogus tests, will be frightened into taking toxic and
life-threatening drugs as a result.
Sooner or later, the public will catch on and you will have
no one to blame but yourselves!
Competing interests: No competing interests
Dear Sir,
We would like to congratulate Moynihan et al (1) on their enlightening
article on the manipulation of medical knowledge by the pharmaceutical
industry. They mention social phobia as one example, but as Double
suggests (2) this process is endemic in psychiatry. Since the 1950s drug
treatments have dominated psychiatric practice and set the agenda for the
majority of psychiatric research. This is despite the fact that it remains
difficult to demonstrate that long-term outcomes are any different than
they were 100 years ago (3).
The influence of the pharmaceutical industry is particularly
pernicious in psychiatry where the possibilities for colonising ever more
aspects of human life are potentially limitless. Psychiatry is an area of
controversy, where different paradigms and approaches to treatment are
hotly contested. The financial muscle of the pharmaceutical industry has
helped to tip the scales in favour of a predominantly biological view of
psychiatric disorder. This has submerged alternative therapeutic
approaches, despite the fact that user-led research indicates that service
users find a wide variety of non-medical approaches valuable in coping
with emotional distress (4).
We believe that it is time to uncouple the "unholy alliance" between
psychiatry and the pharmaceutical industry. Psychiatric service users are
profoundly suspicious of this relationship. Last year they organised a
demonstration against sponsorship of the Royal College of Psychiatrists
conference reported by the national press (5). Members of the Critical
Psychiatry Network supported this demonstration.
In the interest of education and science, the medical Colleges must
be seen to be independent from the commercial interests of the
pharmaceutical industry. The starting point in this debate has to be
absolute transparency concerning the relationship between the Colleges and
the industry. In February this year we wrote to the President of the
Royal College of Psychiatrists requesting information as to the extent of
drug company sponsorship. We await a reply. The Critical Psychiatry
Network argues that the Royal College of Psychiatrists must decline
commercial sponsorship for all educational activities including its annual
conference. These steps are necessary to distance the profession from the
industry and improve its credibilty with service users and the public. We
shall be campaigning actively to achieve this.
Yours etc.
Dr Joanna Moncrieff
Dr Phil Thomas
Co- chairpersons of the Critical Psychiatry Network
References
1) Moynihan R, Heath I, Henry D. 2002 The pharmaceutical industry and
disease mongering. BMJ, 324, 886-891.
2) Double D. 2002 The limits of psychiatry. BMJ, 324, 900-904.
3) Healy D, Savage M, Michael P, Harris M et al. 2001 Psychiatric bed
utilization: 1896 and 1996 compared. Psychological Medicine, 31, 779-790.
4) Faulkner A. 2000 Strategies for Living: a report of user lead research
into peoples strategies for living with mental distress. London: Mental
Health Foundation.
5) 'Psychiatry agenda set by drug firms'. Guardian newspaper, July 9th,
2001
Competing interests: No competing interests
NUMBERS GAME.
Dear Editor,
An interesting addition to the long list of "doctor-thinks-you-have a
disease" syndromes that keep the pharmaceutical and technology tills
moving.
An unethical game with a potentially dangerous drug, indeed. This is one
of the reasons why modern medicine, at times, becomes unattractive to even
those with free access!
Congratulations for publishing this article. May the author's tribe
increase for the good of mankind.
yours ever,
bmhegde
Competing interests:
None declared
Competing interests: No competing interests