Aim: To increase awareness
amongst psychiatrists and trainees of the effects of pharmaceutical
promotion and to stimulate careful evaluation of the relationships between
psychiatry and the pharmaceutical industry.
Method: Key findings
from the literature and from 20 years experience with the Medical Lobby for
Appropriate Marketing are summarised.
Results: The relationship between doctors and pharmaceutical
companies is shown to be problematic in a way that might negatively impact
on patient care.
Conclusions: Patients may benefit if individual psychiatrists, and
the profession as a whole, develop more healthy scepticism about the harm to
benefit ratios of relationships with the pharmaceutical industry.
The pharmaceutical industry is huge
and growing fast. Expenditure by the Australian Pharmaceutical Benefit
Scheme has grown from $1.18 billion in 1989-901(9.0% of total Australian health expenditure) to $3.07
billion in 1998-992
(13.2%). Consequently, the extra billions spent on drugs have been at the
cost of decreased funding for hospital and community health care. This would
be acceptable if it could be demonstrated that expenditure on drugs was
producing better results than expenditure on other areas, but such evidence
is lacking. Continuous growth of the Pharmaceutical Benefits Scheme at rates
much faster than the Australian economy is not sustainable, so that some
type of dramatic change is inevitable. One option is to increase patients'
co-payments but that would disadvantage poorer and sicker people
disproportionately. Other initiatives aimed to slow this unsustainable
growth, including the introduction of therapeutic group premiums, have not
solved the problem, with 14.5% more being spent in 1999 than in 1998.3 Perhaps part of the problem lies in the Therapeutic Goods
Administration requirement that, for a new drug to be licensed, the
manufacturer only needs to demonstrate quality, safety and efficacy for at
least one indication.4 The
new drug need only be better than placebo without being shown to be as good
as currently available medications. This means that new and more expensive
drugs can be introduced on to the market without any potential benefit to
health care. For example, one of the main drivers of increasing expenditure
is use of newer antihypertensives, many of which are either unproven or are
inferior to much cheaper old thiazides
5($0.78/month for Diclotride 12.5 mg/day versus Norvasc
5mg at $19.40/month, wholesale prices). It might make more sense to require
new drugs to be demonstrated to be superior to existing medication in either
safety, efficacy or price before a license is granted.
Because of this
huge and increasing expenditure, it is timely to review the effects of drug
promotion on psychiatrists and our patients. Sara and Prior have recently
called for discussion of three options for improving drug company
involvement in Continuing Medical Education for psychiatrists: prohibition,
declaration and/or engagement.6
This paper provides evidence to support that call. We also aim to show how
pharmaceutical company involvement in Continuing Medical Education fits
together with other (often less overt) components of drug promotion, and to
stimulate reconsideration of whether or not drug promotion is good for
patients. Drug promotion ("all informational and persuasive activities by
manufacturers")7aims to
overtly and covertly alter peoples thinking and feeling, motivating them to
increase the use of a product, service or idea and/or increase the price
that can be obtained. Promotion is a sophisticated applied science. It has
utilised not only high quality qualitative research,8but also controlled trials, the methodology of which was
more advanced in the early 20th century than that of many current medical
trials.9
Pharmaceutical companies use the most effective promotional methods that
they can to increase sales income. They have a legal obligation to maximise
profit for shareholders, as well as self-interest in maximising income for
staff and for the company as a whole.
10 If companies do not perform competitively, and grow, they get
taken over. These forces acting on drug companies mean that priority is
often given to short-term performance at the expense of longer term
considerations. Drug companies have little choice but to do whatever works
to increase the sales of more expensive drugs, regardless of the impact on
health care. Thus the hard sell is an inevitable consequence of the way that
drug companies are paid. It is incorrect to blame drug companies for what is
really a system problem. But it would also be helpful to understand better
the processes within companies that facilitate the promotion of expensive
drugs. It appears that many drug company staff, especially drug
representatives, genuinely believe that their drugs are superior to the
alternatives, in spite of equivocal or contradictory evidence. This may
arise from deliberate deception during training11or unintended "groupthink".12 In any event, pharmaceutical companies seek to influence
us through direct promotion, illness promotion, and influencing research
activities. We will examine each of these strategies in turn and then
comment on the ethics of the relationship between psychiatrists and
pharmaceutical companies.
Perhaps the most important decision all doctors must make is to choose
which information sources to use for professional growth and keeping up to
date. Promotional material produced by the pharmaceutical industry is a
popular choice because it appears to be doctor friendly. Drug promotion does
not influence all of the doctors all of the time, but is effective enough to
justify average promotion costs of around 30-35% of sales.13 Of the $3.07 billion Australian taxpayers paid to
pharmaceutical companies in 1998-99 via the Pharmaceutical Benefit Scheme,
the best estimate is that about $1 billion was spent on drug promotion. In
spite of doctor's views to the contrary, there is clear evidence that such
promotion is effective.14
In May 2000 there were 47,550 prescribing doctors in Australia including
part timers.15 This
suggests that the industry is spending on average approximately $21,000 on
each doctor per year. This average figure gives only a limited picture of
the situation because the range is probably very wide and the distribution
skewed with a small number of opinion leaders receiving more. However, it is
interesting to compare that average with the annual expenditure by
government on full time medical students of about $25,000 (estimate provided
per phone by a senior staff member of the Australian Medical Council).
Clearly, the expenditure by government during a few years of medical
education is dwarfed by the expenditure by the industry on "re-education"
over a medical career. Generally "medical education" sponsored by
pharmaceutical companies favours drug over non drug treatment.16
Many promotional activities have only a small impact on their own but
have a cumulative influence when repeated and/or combined with other
activities. In fact the small impact may enable the message to reach the
subconscious mind under the radar of conscious critical appraisal.17 Those of us who do not think we are influenced by
advertising may be especially vulnerable. Orlowski and Wateska studied
hospital doctors who denied that going to all expenses paid seminars at
popular vacation sites would influence them. However, their prescribing of
the promoted drugs did increase significantly starting from immediately
after they received their invitations.18 Stelfox et al. showed that authors supporting the
use of calcium channel antagonists were significantly more likely to have a
financial relationship with manufacturers of these drugs.19 A study of 109 advertisements in 10 leading medical
journals found that 44% would lead to improper treatment if relied upon.20 Forty per cent of ads showed an unfair balance between
benefits and adverse affects, 60% had images which inappropriately minimised
concern about side effects, and 80% made unsupported claims. In a small
convenience sample of drug representatives who knew they were being
tape-recorded, the approved product information was contradicted at least
once during 11 of 16 visits to GPs in Melbourne.21 A recent Australian study found that lack of scepticism
about drug promotion predicted variations in GPs beliefs about the
appropriateness of unproven expensive new drugs.22Enforcement of controls over advertising is very difficult
because sales material has a very short life cycle. If there are any
objections to it, by the time they are processed, the material has already
been replaced.
The pharmaceutical industry has another more subtle way of maximising
profit, which can potentially adversely influence doctors' abilities to make
the best decisions for patients. Pharmaceutical companies do not just
promote drugs, they also promote illness (which of course leads to increased
sale of drugs).23 They do
this by sponsoring or producing material for GPs, doctor's waiting rooms and
others that alert the medical and lay community to the existence of "new"
conditions like social phobia, or "underdiagnosed" ones, like dysthymia. Of
course, we doctors collude with this process by being too ready to redefine
dissatisfaction with unsatisfactory predicaments as depression. Giving
patients antidepressants can be a way of avoiding their misery. A favoured
means of promoting new illnesses is for drug companies to invest in consumer
support groups. It is cost effective for drug companies to invest in such
groups without any direct promotion of their product (or indeed of drug
therapy). The support groups ensure that new patients present to doctors
with ready-made diagnoses. One advantage for pharmaceutical companies in
using these forms of promotion is that they do not need to make a direct
connection between the illness and their product. This allows them to
present what they are doing as community service. The reason that they do
not need to link their products to this covert promotional material is that
their detailers' orthodox promotional programmes, apparently independently
but often in a well organised way, have already "educated" us doctors, so
that we are ready and willing to prescribe for these disorders.
A third indirect way of maintaining profitability that threatens our
capacity to make the best decisions for our patients is the way in which
pharmaceutical companies are increasingly able to control the flow of
information. This control arises out of the compromise made by medical
researchers in accepting funding from pharmaceutical companies, and we as a
profession must acknowledge our share of responsibility rather than simply
blaming the pharmaceutical industry. Dr Betty Dong was funded by Boots to
determine whether Synthroid was biologically equivalent to the inexpensive
generic form of the compound. When Dong found that it was, she was prevented
by a contract that she had signed with Boots from publishing her data. Her
university initially supported her in attempting to defy the bans, but was
silenced by Boots' lawyers.24
Even without such contractual restrictions, the medical research system has
a role in colluding with the dominance of patented over generic drugs
through the reluctance of medical journals to publish negative conclusions
about differences between drugs.
There is also considerable opportunity for hidden promotion in the
funding of research. For example, many so-called research studies seem
designed to familiarise doctors with drugs and encourage their use, rather
than to contribute to scientific knowledge. This may be particularly the
case where doctors are flattered (and financially rewarded) by invitations
to participate in international, multicentred trials. In such cases, invited
centres are not required to make any scientific contribution to the process.
The first author was recently approached with a request to participate in a
multicentre trial of an SSRI drug for Obsessive- Compulsive Disorder. He was
offered the status of "chief investigator" if he could provide patients,
even though he has no particular expertise in the area being researched, or
in drug trials.
Effective promotion is not restricted to support of major research
projects or offers of all expenses paid overseas travel. Even small gifts
are a way of creating obligation, either consciously or sub-consciously.
Gifts are different from contracts, where the obligation is known and overt.
On the whole, corporations get better return from the sense of obligation
that is induced by gifts than they would from overt agreements to exchange
services for money. Cheap gifts should not be thought of as harmless
indulgences, but as low cost, highly cost effective advertising.25 It is noteworthy that drug companies such as MSD have
forbidden their own staff from accepting gifts, presumably because they know
that gifts are effective.26
"Education" provided by or sponsored by drug companies is another subtle but
effective gift.
One of the important ethical issues with drug promotion is that the money
being spent is public money. This raises the issue of accountability. In our
dealings with consumer goods, we usually tolerate the fact that advertisers
distort the profile of products, highlighting their good points and hiding
their bad points. With most consumer products, this distortion is accepted
because the consumer, who is paying for the goods, is often in a reasonable
position to exercise his or her own judgement. In the prescription drug
market, this is not the case. It is taxpayer's money that is being spent on
drugs, but the government exercises very little control over which drugs are
being bought for its money. It is we doctors who write the scripts, and
thereby place orders (on behalf of our patients), but we do not feel the
cost. The pharmaceutical industry's marketing plans involve the preferential
promotion of more expensive drugs. Most of us like shiny new things, even if
they do not do the job better. Both authors love kitchen appliances. We get
a steady stream of advertising pushing us to buy newer, smarter, brighter
models. We stick, somewhat reluctantly, with our old ones because we would
have to pay, and advertisers have to compete against our bank managers. Such
is not the case when the drug company markets drugs for our patients.
Doctors take at least as much pride in our patients' wellbeing as we do in
our cooking. So, without a bank manager looking over our shoulder, we can
upgrade drugs on a whim. Most of us do. But as we have argued, there is no
evidence that these decisions will significantly benefit our individual
patients (as exemplified by newer generation antihypertensives) and the
extra costs will disadvantage the health system as a whole, and thereby
potentially increase morbidity. Furthermore, the ultimate consumers - our
patients - often are not in a position to make informed judgements about the
product, as evidenced by the market success of benzodiazepines in the 1970s.
It does not seem that there is an attitude of mutual respect between
doctors and drug companies. On our side, it is not uncommon to hear
psychiatrists, including those receiving significant rewards from drug
companies, making disparaging comments about the industry. On the other
side, we are regarded somewhat cynically. According to an experienced member
of the pharmaceutical industry, a drug company will hand pick doctors to
fund for research and "educational" activities specifically for their
supportiveness and loyalty to the company, on the basis of analysis of their
prescribing habits and profiles. The industry follows the principal that 80%
of the market comes from 20% of the prescribers. We are therefore
categorised according to how we prescribe, from "A" (high volume prescribers)
down to "C" (those not worth targeting). "A"s are well looked after, while "B"s
are targeted with a view to converting them to "A"s. Drug detailers profile
us during their visits according to our professional and private interests,
and also obtain information about our prescribing from local pharmacies. Our
names appear in company briefing documents, with notations about who has
attended international and other conferences as part of their promotional
package, and what the company hoped to achieve from that sponsorship.11 At the same time, we are the targets of advertising
campaigns that do not flatter our intellect. Keizer notes
"professional medical magazines are filled with advertisements about
medication in which the doctor is approached on the level of the
housewife and her washing powder ... It's a kind of science in "drag"
... which far below the cortex, runs along its brief spinal trajectories
(not one cortical neurone even shimmering briefly in this darkness) and
which is taken seriously by doctors and patients. Now, the
pharmaceutical industry has, after a training period lasting several
centuries, developed an incredible finesse in adopting a cortical manner
while selling spinal reflexes".
27(p67).
Lest this seem fanciful, Williams Douglas McAdams, Inc, a company that
designs drug advertisements for the pharmaceutical industry, advertised
their services to drug companies with an ad headed "Straight to the
Hippocampus" which portrayed the hippocampus as "the prescription-writing
centre of the brain". The marketing company boasted "all our communications
are focussed on making the hippocampus respond favourably to your product",
"connecting new concepts with the parts of the brain where gut instincts are
formed".28
How then can we better manage our relationships with the pharmaceutical
industry? At the national level there is an urgent need for policy
development on drug promotion. One approach is increased regulation, but it
must be understood that any attempts at regulation will fail unless they are
well resourced to support training of regulators to the very high levels of
expertise required. To be successful, regulators would need to be able and
willing to impose a wide range of sanctions, including removing companies
from the market. A more promising approach involves reform of the way that
drug companies are paid. For example, under the capped annual contracts used
in New Zealand, excessive sales are unprofitable. Under that system, company
representatives visit over-prescribing doctors to encourage them to be more
prudent in the interests not only of their patients but also the company.
Use of capped annual contracts is a relatively simple approach but is too
blunt an instrument to solve all the problems of inappropriate behaviour. It
may be better, although more complex, to give drug companies the opportunity
to earn a significant part of their income via bonus payments for meeting
quality targets that measure their contribution towards more appropriate use
of therapies.
For us as psychiatrists, there is an urgent need for research on what we
can do to reduce the harm from misleading drug promotion. Meanwhile it is
likely to be beneficial for patients if we achieve the golden mean in
confidence levels. This is because doctors who are under confident are
easily swayed but doctors who are over confident are made vulnerable by
their false sense of security. Patients are likely to benefit if doctors
avoid contact with drug companies when possible, become very sceptical of
promotional claims from any source and gain skills at critical appraisal of
both the medical literature and promotion.29
Affiliations
aDepartment
of Psychological Medicine, Women's and Children's Hospital, North
Adelaide, SA 5006, Australia. Fax: (08) 8204 7032 Email:
jureidinij@wch.sa.gov.au bDirector, Medical Lobby for
Appropriate Marketing, 34 Methodist St, Willunga SA 5172, Australia.
Fax: (08) 8557 1040 Email: peter@healthyskepticism.org
Correspondence
Dr Jon Jureidini,
To cite this article Jureidini, Jon & Mansfield, Peter
Does drug promotion adversely influence doctors' abilities to make the
best decisions for patients?. Australasian Psychiatry 2001; 9 (2), 95-99.
Pahor M, Psaty B, Alderman M et al. Health
outcomes associated with calcium antagonists compared with other first-line
anti-hypertensive therapies: a meta-analysis of random controlled trials.
Lancet 2000; 356 (9246):1949-1954.
Medline
Lexchin J. Interactions between physicians and the
pharmaceutical industry: what does the literature say? Canadian Medical
Association Journal 1993; 149: 1401-1407.
Medline
Orlowski JP & Wateska L. The effects of
pharmaceutical firm enticements on physician prescribing patterns: There's
no such thing as a free lunch. Chest 1992; 102: 270-273.
Medline
Stelfox HT, Chua G, O'Rourke K, Detsky AS. Conflict
of interest in the debate over calcium-channel antagonists. New England
Journal of Medicine 1998; 338: 101-106.
Medline
Wilkes MS, Doblin BH, Shapiro MF. Pharmaceutical
advertisements in leading medical journals: Experts' assessments. Annals
of Internal Medicine 1992; 116: 912-919.
Medline
Roughead EE. The Pharmaceutical Representative
and Medical Practitioner Encounter: Implications for Quality Use of
Medicines. Masters Thesis, School of Health Systems Sciences, La Trobe
University, August 1995.
www.healthyskepticism.org/reps/tindex.htm
Shaughnessy AF, Slawson DC, Bennett JH. Separating
the wheat from the chaff: identifying fallacies in pharmaceutical promotion.
Journal of General and Internal Medicine 1994; 9: 563-568.
Medline
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"