Doctors and drug companies are locked in “vicious circle”
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7473.998 (Published 28 October 2004) Cite this as: BMJ 2004;329:998
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The main problem is that new drugs are developed by private companies
but most of their income consists of public money (e.g. via the National
Health Service in the United Kingdom). Thus public money is being given to
private companies to use as they wish, and some of it is used to research
and market unneccessary new drugs. Drug companies are trying to make a
profit and are naturally expected to make decisions which are best for
themselves, and they are competing against similar companies which do
likewise.
I think that research for new drugs would be best carried out by an
organisation which is not required to make a profit, and can set its
research priorities for the greatest overall benefit for mankind. One way
might be to significantly increase funding for the World Health
Organisation so that it can run its own drug company, which would be
financed partly from the grant and partly from drug sales and licence
fees.
Competing interests:
Former employee of Medicines and Healthcare products Regulatory Agency, UK
Competing interests: No competing interests
I thank Bob Brecher for his comments, they are spot on.
The disgraceful collaboration between Establishment Medicine and Big
Pharma must stop. If this has to be done by heavy handed methods like
draconican legislation so be it.
It seems to be a human thing to be always in the mood to embrace
corruption as we can clearly see in the alternative health 'industry'
where many products are pushed that have questionable efficacy but sport
obscenely high prices.
Many doctors see nothing wrong with being wined and dined by Pharma
Reps in exchange for practicing their particular brand of evidence based
medicine.And, I might add that a large percentage of practicing physicians
have lost touch with who they are and how ridiculous the concept of
omnipotence actually is.
Some of them practice under false pretenses, most of them enjoy the full
support of Big Pharma and few of them remember what they went into their
profession for.
I like the Chinese concept of paying the doctor out of each person's
pocket to keep them well and have the payment stop if the patient gets
sick.
While I am not radical enough to support the idea that all business
is -by its very nature- corrupt it must be obvious to all that the
bedcovers need to be yanked off the medical-pharmaceutical love affair,
COMPLETELY, to expose all sleazy activities and punish the players by
public ridicule and appropriate chastity measures.
In this day and age, the priorities of many have fallen out of order
and our current dilemma will not be solved until the prospect of
unlimited amounts of those proverbial pieces of silver is taken out of
what really ought to be called Profit-Base-Health Care.
Competing interests:
None declared
Competing interests: No competing interests
The article highlights a fundamental problem about the role of the
pharmaceuticals and what might be termed the collaboration of the medical
profession with that role. Unhappily, however, piecemeal changes are
neither
realistic nor adequate. Until and unless the production, supply and
development of drugs is taken out of the hands of private interest and
profit
-- that is to say, decommodified -- the problem will remain. Regulation,
even
if well-intentioned rather than merely cosmetic, will always be
circumvented, and by both parties. In short, the issue, like so many in
contemporary medicine, is inescapably a political one. Properly to resolve
it
rather than merely to tinker with the details of exploitation, would
require a
shift in political thinking that is scarcely conceivable. Nonetheless, the
argument needs to be made, however unrealistic it may seem in the context
of the actually existing political order -- otherwise even the ideal will
be lost
to future generations.
Competing interests:
None declared
Competing interests: No competing interests
This article raises the typical debate between haves and havenots.
As the title suggests,it has been conclusively proved that drug promotion
affects prescription of Physicians.Inducements have a long term role to
play in the same.
In developing countries,public spending on health is either static or
declining.Herein much of the void is filled in by private practitioners
who remain an ideal target for drug companys' representatives.
In the past 15+ years much of the research has veeered off to designer
drugs i.e.for obesity or hypertension.The drug industry is silent on the
new therapies for Malalria or re-emerging infections which account for
nearly 10% of the global disease burden.Where is the "increased spending
on research" Mr.Gray?Could you provide facts and figures?How can you
account for increased stock holding of the drug company promoters?
Drug companies spend more on advertising than the consumer good
companies.Obviously increased advertising,by any means,means more sales
and hence more profits.This is because of the inherent price differential
of the marketed drugs from the actual costs of production.Who pays in the
end?The consumer.
I wish there were better regulation of the promotion.Specially in those
countries where there is not much to differentiate the
generics.Pharmaceutical companies have a lot to say for instead of getting
in the denial mode as the previous response seems to suggest.
Competing interests:
None declared
Competing interests: No competing interests
Alexander Gray stated in his rapid response letter [1] that "Dr
Mansfield most certainly needs to provide evidence that reducing drug
promotion promotes health. In what way is the promotion of drugs within
their licence in line with evidence of their clinical benefit deleterious
to health? Does he seriously suggest that there is an inverse relationship
between promotional spend and the health of a nation? Do countries with a
high promotional spend (such as the US) have poorer health than those
where the promotional spend is low? In making this unestablished link, he
treats drugs like tobacco: The difference is that drugs improve, not harm,
health."
First of all, Alexander Gray implies that drug companies only promote
drugs in line with evidence of their clinical benefit. I think that the
"real world" evidence supports a different conclusion. I think that drug
companies promote their drugs only to increase their market share, and
that they frequently overstep the boundary of EBM-supported evidence. By
doing so, they act like tobacco companies (and harm society), because
increased expenditure on expensive trade-name drugs diminishes the amount
of money that can be more fruitfully spent on more clinically useful
health care services. A good example of that phenomenon is the promotion
of Vioxx (rofecoxib), instead of cheap generic NSIADs, for the treatment
of common inflammatory conditions. Billions of dollars were used to
promote that drug (which directly increases the drug's costs because all
marketing expenditures are added to the drug's cost), and billions of
drugs were spent by drug consumers to purchase that drug, even though
there is no EBM evidence that rofecoxib is better than standard NSIADs
like ibuprofen and naproxen. In fact, the harm:benefit ratio actually
disfavors the use of rofecoxib (which is associated with an increased risk
of adverse of cardiac events). By wasting billions of dollars on a trade-
name drug that didn't offer a better risk:benefit ratio than a similar
generic drug, the health of the nation is being harmed by the wasting of
"potential" health care dollars that could be better used to fund more
clinically useful health care services. The same phenomenon applies to the
promotion of Nexium, as an alternative to an off-patent form of a similar
proton pump inhibitor drug. Nexium is not superior to similar over-the-
counter proton pump inhibitors, and any expenditure on Nexium likewise
harms society by unnecessarily wasting "potential" health care dollars.
There is also substantial evidence to support the belief that small drug
companies are developing the few innovative drugs that are presently being
introduced into society's drug armamentarium, and that the major
pharmaceutical companies are mainly spending their money producing "me
too" drugs that are no better than off-label generic drugs.
Alexander Gray states "Dr Mansfield seems unable to understand that
the pharmaceutical industry, far from being a leach on society in the way
that he presents it, funds the overwhelming bulk of medical research, and
much of medical education. It has provided almost all of the drugs that
many take daily, with clear benefits in quality of life, morbidity and
mortality. Without the industry, both the quality and length of life of
the population would not have improved by anywhere near the margin it has
done over the last century. In what sense then does pharmaceutical
promotion "harm health"?"
It is true that the pharmaceutical industry has produced the
overhwelming bulk of medical research pertaining to the drugs that many
take daily. However, I disagree that it has done so in a cost-effective
manner. Most of the medical research dollars have been spent on developing
"me too" drugs that do not significantly advance the health of the world's
citizens. As Peter Mansfield has pointed out in his memorandum [2]--
"Rather than aiming at greatest medical need, current systems for paying
drug companies reward research and development of “me too drugs” for
chronic conditions of people who have the greatest capacity to pay." By
doing so, pharmaceutical companies are acting like a leach on society.
They are draining society of health care dollars that could be spent on
developing innovative drugs that treat serious diseases like malaria,
instead of being spent on more "me too" drugs that treat non-urgent
conditions like erectile dysfunction. I think that the appropriate
response to this scandalous situation should be multi-pronged. I think
that society should fund health care research mainly via government-
sponsored (tax-payer funded) clinical research, and that all clinical
research should be performed by independent clinical research units that
are "sequestered". Private pharmaceutical companies that develop
innovative drugs in their research laboratories, should be obliged to pay
a user-fee to have those drugs clinically tested by those independent
"sequestered" clinical research units. It is only by instituting an
"independent" clinical research system, which totally separates
independent clinical researchers from private pharmaceutical companies
(who fund the clinical research by paying user-fees), that society can be
relatively certain that its research dollars are being fruitfully spent. I
think that Peter Mansfield's so-called "radical" suggestions are far too
tepidly radical [2], and I do not think that they will not solve this
serious problem.
Alexander Gray states that the pharmaceutical industry is responsible
for much of society's medical education. I don't know to what degree this
statement can be conceived to be true, but I think that society should
ensure that pharmaceutical companies have no connection with medical
education, whatsover. Individual physicians, and professional physician
organisations, should totally refuse to have any medical education
financed in anyway by pharmaceutical companies. Medical education should
only be provided by independent medical schools, independent professional
medical organisations and independent medical educational entities. I
think that medical schools and professional medical organisations have
done a poor job of providing community clinicians with systematic reviews
of scientifically valid EBM evidence in such a manner that community
clinicians are educationally well informed. It is a travesty that most
community clinicians mainly acquire their limited knowledge of recent EBM
evidence from drug company representatives, drug company sponsored socio-
educational meetings, and drug company sponsored non-peer reviewed, "throw
-away" medical journals. The major blame for this travesty lies with the
medical profession (individually and collectively) -- it should ensure
that clinicians are educated by people who have no 'conflict of interest'
connection with the pharmaceutical industry. A "no free lunch" attitude
must become the prevailing attitude!
Jeff Mann.
References:
1. Gray, A. Healthy Skepticism should be careful in linking a demise
of drug promotion to better health. BMJ rapid response letter. October
2004.
2. Mansfield PR. Healthy Skepticism about drug promotion. Memorandum
for the UK House of Commons Health Committee Inquiry: THE INFLUENCE OF THE
PHARMACEUTICAL INDUSTRY Healthy Skepticism Inc 2004
www.healthyskepticism.org/advocacy/2004/UK_Inquiry.htm
Competing interests:
None declared
Competing interests: No competing interests
sir,
its very heartening that some doctors are really bothered about the issue.
i do not know about other countries but here in India i find it
highly unfortunate scene as far as doctor -pharma nexus is concerned .
you can get anything prescribed from doctors no less than head of
departments of various medical colleges for petty incentives.
when teachers are irrational and corrupt , why blame new doctors?
the funny part is that the same corrupt doctors only are office bearers of
all big medical associations and they only conduct all clinical trials !
I donot see any ray of hope in our country at the moment.
your,s
dr, navin modi
Competing interests:
None declared
Competing interests: No competing interests
Dr Gray's response to Melissa Sweet's article mirrors the current
polarised world of doctor-industry relationship.
Life is seldom in black and white.It is mostly shades of gray.Both their
positions are perhaps extreme and the often ignored middle-ground appears
to be the way forward.
No body doubts that drugs improve health,but the manner in which the
industry has moved away from addressing the real medical needs of the
world,with its huge resources focussed more on marketing muscle flexing,
creatng profitable diseases/therapies than towards discovering really
innovative drugs is not in the interest of both humanity and industry. The
industry really needs to introspect and implement course correction.There
is enough data in public domain to show that business factor rather than
medical need dictates choice of R&D venue & spending. Emergence of
orphan drugs, neglected diseases are examples of patients losing out to
stakeholders.
"The absence of profits would prevent these (R&D and
education)activities" right. But the quest for incremental profits through
"me-too" drugs, analogs, next-in-class drugs would in the long run
discourage discovery of new receptors, enzymes, ion-channels and other
"targets". I agree fully with Dr Gray that philanthrophy is not a serious
alternative to commercialised drug development. At the same time the
industry has to prove to the society that its raison d'etre is not profits
but the discovery of really effective and safe medicines for diseases that
matter.The current groundswell of negative public opinion on both sides of
the Atlantic clearly suggests that the industry needs to re-align its
priorities.
Doctors are really at the heart of this matter: they can engage the
industry to develop the drugs that really make a difference to patients.No
industry can corrupt the doctor who does not want to be corrupted.
In the final analysis "virtuous and viscious all men must be; few in
the extreme but all to a degree".The industry should make decent profits
in return for its efforts in R&D.It is all a matter of degree.
Competing interests:
I am medical director of pharmaceutical company.
Competing interests: No competing interests
I thank Melissa Sweet for her concise report and Alexander Grey for
his important questions about Healthy Skepticism’s contribution to the UK
House of Commons Health Committee inquiry into the influence of the
pharmaceutical industry. We recommend reforms designed to:
1. Increase regulation of drug promotion
2. Improve medical decision making
3. Redesign the incentives for doctors
4. Redesign the incentives for drug companies
Copies of our memorandum are available at our website:
www.healthyskepticism.org <_1/>
Melissa Sweet is correct to call our proposals “radical” in the sense
that they address the roots of the problems so as to treat the causes of
inappropriate drug use. However our proposals are not politically extreme
and few of them are new. Most of the components are already well tested.
Since our memorandum was written we have an economic revaluation of four
proposals for reform of research funding has found that a proposal by US
Representative Dennis Kucinich is the best or equal best on all
criteria.<_2/> That is very similar to, and entirely consistent with,
our proposals for funding research. However our proposals also cover all
the other functions of the pharmaceutical industry.
We don’t suggest changing the level of public funding for the
pharmaceutical industry that already occurs in countries such as the UK
but our proposals may justify increases.
Our key proposal is for taxpayers’ money to be spent via separate
publicly accountable open competitive tender systems for separate
functions (research, manufacturing, promotion, education, etc). This would
enable incentives to be aligned with good performance in those functions.
It would also enable for-profit and non-profit organisations (eg
Universities) or consortia including both to compete on merit for
contracts that would provide more reliable, sustainable and higher returns
on investment. To make our proposals politically achievable we have
designed them to benefit not just the public but also health professionals
and pharmaceutical industry staff.
I don’t know if Alexander Grey deliberately used the straw man
fallacy<_3/> or made an honest attempt to guess our position and got
it completely wrong. I will respond to his challenges in order.
Our 9 page memorandum includes the following introduction to the
evidence about drug promotion:
“All of the studies, that we are aware of, that measure the impact of
exposure to and attitudes towards drug company information on the quality
of medicines use support the same conclusion. The more doctors depend on
drug company information, the more medically inappropriate and expensive
their prescribing.<_4-15/>
It is likely that drug promotion can be beneficial when the following
conditions are met:
* the information used is reliable, balanced and relevant without
significant omissions.
* the drug has a superior ratio of benefits over harms and costs compared
to current treatments for a specific indication.
* the drug is currently underused for that specific indication.
* the promotion is targeted at increasing the use of a drug for the
specific indication to appropriate levels and not beyond.
However, those conditions are rarely met. The percentage of new drugs
that have any medical advantage over older cheaper drugs has been assessed
as only 23% during 1989-2000 in the USA and only 10.5% during 1980-2003 in
France.<_1617/>
A major economic study of drug promotion in The Netherlands concluded
that the 'average effect of [drug] marketing on price elasticities is
unambiguously welfare-negative. This is because the effect we see is an
effect after correcting for quality differences and this allows us to
interpret the lower sensitivity to prices as brand loyalty not supported
by product characteristics. This is socially undesirable.'<_18/>
We conclude that drug promotion is an effective tool that can be used
for good or ill. However, currently drug promotion does more harm than
good.”
The root cause of inappropriate drug promotion is inappropriate
incentives. Unless the incentives can be redesigned we recommend that drug
promotion be reduced to the extent achievable.
Alexander Grey asked: “Do countries with a high promotional spend
(such as the US) have poorer health than those where the promotional spend
is low?” The answer is that the US spends more per capita on health than
any other country but has lower healthy life expectancy at birth than
Andorra, Australia, Austria, Belgium, Canada, Denmark, Finland, France,
Germany, Greece, Iceland, Israel, Italy, Japan, Luxemburg, Malta, Monaco,
Netherlands, New Zealand, Norway, San Marino, Slovenia, Spain, Sweden,
Switzerland and the UK.<_18/> However, drug promotion is only one of
the reasons why US healthy life expectancy (69.3 years) is so low and
little better than Cuban healthy life expectancy (68.3 years).<_19/>
Opposite to Alexander Grey’s assertion we advocate distinguishing
between education (increasing knowledge and skills) vs promotion
(persuasion and motivation aimed at behaviour change) by paying for them
separately.
Alexander Grey asked: In what way then has the promotion of ACE
inhibitors been deleterious to health? The answer is that there has
probably been direct harm because these drugs are probably less beneficial
for hypertensives than chlorthalidone<_20/> but certainly major harm
from opportunity costs because they are more expensive.
Contrary to Alexander Grey’s assertion we have not presented the
pharmaceutical industry as a leach but rather as a product of
inappropriate incentives. We note that in countries such as the UK
taxpayers fund research and medical education via high prices for drugs.
Taxpayers would get better value for money by funding these functions
separately as outlined above.
Alexander Grey asked whether we could find organisations comfortable
with spending billions every year on research, with a 1 in 10 chance of
success for each compound. The answer is that this is what governments,
insurance companies and individuals already do if they pay for or
subsidize drug prices set higher than manufacturing costs so as to provide
incentives for research. Our proposals for better value for money via
improved accountability and targeting would increase their comfort as well
as improving health.
Alexander Grey asked: Does Dr Mansfield deliver healthcare to
patients for no return? I receive payments per session as a general
practitioner. My research work is funded by competitive grants so I am
already practicing what we advocate.
Alexander Grey falsely accuses us of communist fantasies. By
contrast, competitive tendering is a well proven way to get value for
money that transcends ideologies.
Alexander Grey asserts that “not even the most philanthropic” would
take the risk of investing in drug research. However, the development of
penicillin by Florey et al at Oxford University was funded by
philanthropically by the Rockefeller Foundation so philanthropy has been
proven in the past. Philanthropy remains an important motivation for many
people who organise or participate in research. Our proposals harness
philanthropy better than the current system but do not rely on it. Instead
our proposals are designed to provide better return on investment than is
likely to be achieved in the future if the current system is not reformed.
1. Mansfield PR. Healthy Skepticism about drug promotion. Memorandum
for the UK House of Commons Health Committee Inquiry:
THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY Healthy Skepticism Inc 2004
www.healthyskepticism.org/advocacy/2004/UK_Inquiry.htm
2. Baker D. Financing Drug Research: What Are the Issues? Center for
Economic and Policy Research (CEPR) 2004
www.cepr.net/publications/patents_what_are_the_issues.htm
3. www.fallacyfiles.org/strawman.html
4. Becker MH, Stolley PD, Lasagna L, McEvilla JD, Sloane LM.
Differential education concerning therapeutics and resultant physician
prescribing patterns. J Med Educ 1972;47:118-27.
5. Linn LS, Davis MS. Physicians’ orientation toward the legitimacy
of drug use and their preferred source of new drug information. Soc Sci
Med 1972;6:199-203.
6. Mapes R. Aspects of British general practitioners’ prescribing.
Med Care 1977;15:371-81
7. Haayer F. Rational prescribing and sources of information. Soc Sci
Med 1982;16:2017-23.
8. Ferry ME, Lamy PP, Becker LA. Physicians’ knowledge of prescribing
for the elderly: a study of primary care physicians in Pennsylvania. J Am
Geriatr Soc 1985; 33:616-21.
9. Bower AD, Burkett GL. Family physicians and generic drugs: a study
of recognition, information sources, prescribing attitudes, and practices.
J Fam Pract 1987;24:612-6.
10. Cormack MA, Howells E. Factors linked to the prescribing of
benzodiazepines by general practice principals and trainees. Family
Practice 1992;9:466-71.
11. Berings D, Blondeel L, Habraken H. The effect of industry-
independent drug information on the prescribing of benzodiazepines in
general practice. Eur J Clin Pharmacol 1994;46:501-505.
12. Caudill TS, Johnson MS, Rich EC, McKinney WP. Physicians,
pharmaceutical sales representatives, and the cost of prescribing. Arch
Fam Med 1996;5:201-6.
13. Mansfield PR, Lexchin J. Scepticism and beliefs about new drugs.
Healthy Skepticism International News 2001;19:1/6
www.healthyskepticism.org/editions/2001/IN0106.htm
14. Caamano, F.; Figueiras, A., and Gestal-Otero, J. J. Influence of
commercial information on prescription quantity in primary care. Eur J
Public Health. 2002 Sep; 12(3):187-91.
15. Watkins, C. Harvey, I. Carthy, P. Moore, L. Robinson, E. Brawn,
R. Attitudes and behaviour of general practitioners and their prescribing
costs a national cross sectional survey. Qual Saf Health Care. 2003 Feb;
12(1)29-34.
16. National Institute for Health Care Management (NIHCM) (2002)
Changing patterns of pharmaceutical innovation.
www.nihcm.org/innovations.pdf
17. Industrial interests versus public health: the gap is growing.
Prescrire International April 2004;13:70:71-76
18. de Laat E, Windmeijer F, Douven R. How does pharmaceutical
marketing influence doctors’ prescribing behaviour? CPB Netherlands ’
Bureau for Economic Policy Analysis The Hague, March 2002
www.cpb.nl/nl/pub/bijzonder/38
19. Annex Table 4 Healthy life expectancy (HALE) in all WHO Member
States, estimates for 2002. World Health Report WHO Geneva 2004.
www.who.int/whr/2004/annex/topic/en/annex_4_en.pdf
20.ALLHAT Officers and Coordinators for the ALLHAT Collaborative
Research Group. Major outcomes in high-risk hypertensive patients
randomized to angiotensin-converting enzyme inhibitor or calcium channel
blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to
Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97.
Competing interests:
I am a General Practitioner, an Australian taxpayer, an occasional patient and Director of Healthy Skepticism.
Competing interests: No competing interests
one of the ways in which the vicious cycle can be broken is stressing
evidence based medicine in the medical curriculum.in addition, the nhs
should provide a copy of ebm booklet to every person employed in the nhs
along with bnf, semi-annually or ebm class can be included in the bnf
itself. the drug companies should be roped in to provide these finances.
based on the data provided by the nhs in ebm book or bnf, the physicians
thus would conduct the management of patients. treatment modalities should
be grouped into class 1-3, class 3 being the least useful, where only a
few random publications are present.also in every seminars and symposia
and get-togethers, it should be mandatory for the drug companies
organising the same to state the position of the product they are
promoting in the ebm book. in this way, there will be a check on the drug
companies from going into an advertising blitz. even in advertisement of
drugs, companies should state in small print similar to " this is ebm-
class 3" akin to tobacco warning "injurious to health".
finally for practising physicians, the only sure way is to read certain
standard texts before prescribing the new drugs.
Competing interests:
None declared
Competing interests: No competing interests
What practice guidelines are for ?
I'd like to point out that some of the practice guidelines, which
are growing
rapidly in number, can be very powerful advertising tool and boost sales
of
pharmaceutical companies. The companies are deeply involved in the whole
process of making the guidelines; they pay for the meetings, committees,
participants, and authors of the guidelines. They also play an active
role in
spreading the guidelines. All of these efforts can be paid back if their
products are 'officially' recommended in the guidelines. Dominant drug
companies are conducting large clinical studies to label their product as
'highly recommened' in the guidelines. These trends have potential harm
to
deviate medical practice and can result in a great profit to the
pharmaceutical companies at the expense of patients.
Competing interests:
None declared
Competing interests: No competing interests