Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes
BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4949 (Published 30 November 2009) Cite this as: BMJ 2009;339:b4949
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Dear Ioanna
To your first problem, my answer would be to simply not go to these
"presentations" as they will never contain transparent and comprehensive
data, that is not their purpose. But if you must go, then just don't
listen.
To your second problem, prescribing in any specialty is a frightening
and fraught occupation and unfortunately we have to rely on the evidence
that we have, as imperfect as it often is. Don't forget, your consultant,
registrar, pharmacist, nurse specialists and BNF (which often contains up
to date guidelines) will be at hand to help make these decisions.
Your dream is laudable but it will take a change in our attitudes and
interaction with the pharmaceutical industry, as at the moment, they are
wearing the trousers.
Best wishes
David
Competing interests:
Actively avoids all contact with Big Pharma and encourages his peers to do the same.
Competing interests: No competing interests
As a Foundation Year 2 trainee in Psychiatry I have recently attended
a number of presentations given from pharmaceutical companies promoting
their drugs. During all those presentations I never felt that I was
provided with access to transparent and comprehensive trial data, and in
particular with regards to negative effects of the respective products.
There were no detailed references on a number of trials, apart from maybe
one or two. Finally I was left confused as to the efficacy and actual
differences between the various psychotropic drugs.
Having already decided that I want to specialise in Psychiatry, to me
it is very daunting thinking that from next year I may have to decide
which medication to favour in a given scenario, as from the input that I
have had so far there appeared to be non-availability of a comprehensive
database. There are guidelines (NICE, BAP, Morsley etc) and Cochrane
reviews that advice on assessing all the available drugs of a given
category. But these guidelines are only as good as the available published
literature on those drugs. Obviously, because of the workload that one has
to face on a day to day basis, it would be much more helpful if honest and
transparent trial data were provided to all doctors during the
presentations from pharmaceutical companies.
I believe that the creation of a comprehensive and transparent
database reporting the results of all clinical trials and with the common
participation of all pharmaceutical companies would be an important step
towards increasing awareness among doctors and therefore enhancing
evidence-based medical practice. But then again this may only be an
idealistic dream of a junior doctor!
Competing interests:
None declared
Competing interests: No competing interests
Medical experts with their fingers in the wallets of corporations
are, alas, not new. Consider the physicians hired by Big Tobacco decades
ago to undertake research “proving” that cigarettes were not dangerous to
our health. In 1969, Post-Keyes-Gardner, the ad agency for tobacco giant
Brown & Williamson, relied on the testimony of their hired gun
physicians for a new campaign “to set aside in the minds of millions the
false accusations that cigarette smoking causes lung cancer or other
diseases.” (Handbook of Public Relations, Heath & Vasquez, 2004).
When the Canadian Medical Association Journal reviewed 19 previously
published cardiac studies on the safety of drug eluting coronary stents,
all seven of the studies that were sponsored by the stent manufacturers
recommended "continued widespread use of this device", compared to just
three of the 12 unsponsored independent studies. Despite Dr. Toal's
insistence on blaming everybody BUT the industry for conflict of interest
issues, results like these are distressingly common and appear to clearly
favour Dr. Goldacre's thesis.
As a heart attack survivor who must take a fistfull of cardiac drugs
each day, I have no idea which of my drugs were prescribed to me based on
flawed research that was then submitted to journals as scientific papers
written by industry-paid medical ghostwriters. And worse - neither do my
doctors!
As documents in the 8,400 Wyeth lawsuits underway in the U.S. are now
revealing,[1] 26 fraudulent medical journal articles commissioned by Wyeth
that favoured their HRT drugs Premarin and Prempro by failing to disclose
very real risks of increased breast cancer and heart disease were
successfully published in medical journals. Physicians read and trust what
they read in these journals, and we know that prescribing habits are
changed because of what they read.
My concern: that what we are learning each day in the Wyeth court
cases, among many other landmark legal settlements, is only the tip of a
very large and disturbing iceberg.
Carolyn Thomas
Canada
1 The Public Library of Science Medicine has a full Wyeth Archives link on their site, including links to court documents, at: http://www.plosmedicine.org/static/ghostwriting.action
Competing interests:
None declared
Competing interests: No competing interests
Ben Goldacre criticises the way clinical trials are conducted by
pharmaceutical companies on their own drugs. He points out that the
majority of studies appear to be biased, and the compliance to high
scientific standards is not just the strong point of their initiators.
Overall, the author claims that allowing drug companies to perform
clinical trials on their own products is somewhat like putting the fox in
charge of the henhouse.
In contrast, Vincent Lawton emphasizes that clinical trials are of
high quality and are committed to the responsibility of drug companies to
the public. He gives a summary of the instances that are involved in the
conduct of clinical trials. Among others, ethic committees, regulative
authorities, guidelines and principles of conduct are involved in the
development of a chemical entity to a medicinal product. In his view, a
drug is a highly regulated product for which independent reviewers warrant
strongest quality standards.
The question that rises automatically while reading both statements
about conflict of interest in clinical trials is: How do two persons have
such totally opposed opinions if one considers that they have such a
profound knowledge about the same matter?
In my view, the answer is that they are comparing apples and oranges:
Ben Goldacre completely refers to post marketing studies, whereas Vincent
Lawton claims quality instances that are mainly situated in the
development phase of a drug before it gets market authorization.
I agree with Ben Goldacre as long as he admits that his arguments are
addressing trials that have been performed after a drug has been released
to adulthood, i.e. to the free market. The quality issues he refers to
certainly do apply as there is no general standard how to handle the
knowledge gained after a drug accessed the public – all seems possible.
Presentations of data which are masked with a scientific approach are
barely distinguishable from advertisement.
On the other side, Vincent Lawton, he is also true. As long as a drug
is in development, starting from pre-clinics, advancing to early phase and
reaching the limits of authorization in the late phase of development, it
is highly regulated by authorities and independent instances, where subtle
contortions in favour of the medicinal product has few space.
Given that Ben Goldacre and Vincent Lawton disclose to which part of
a drug's life they refer to with their articles, both opinions appear
valid and the seeming contradiction vanishes.
Competing interests:
None declared
Competing interests: No competing interests
Big Pharma is the preeminent force in healthcare. It controls medical schools,
medical research, medical journals, medical certification, continuing medical
education, health insurance, and health policy. Big Pharma indoctrinates
physicians, patients, and governments with a pharmaceutical orthodoxy that
excommunicates all non-believers as sinners, heretics, and lunatics. In order to
liberate healthcare and promote scientific progress, Big Pharma should fund
independent, ongoing research into its excessive influence over healthcare. But
let’s not hold our breath waiting for this to happen.
Competing interests:
None declared
Competing interests: No competing interests
Goldacre cites various reasons why industry should not perform
studies on their own drugs. There are several broad reasons cited, which
more or less boil down to, in his view, intentional bias. He cites a
systematic review of 30 studies which show that industry sponsored studies
are more likely to show favourable results than non-industry sponsored
studies. The reader is invited to assume this means the data is doctored
or some other form of skullduggery is at play.
However there are other explanations, the most obvious of which is
that industry is rather more careful to select drugs which have a good
chance of success. Non-industry sponsors generally do not make the same
level of investment as industry sponsors, and getting it wrong (i.e that
the drug is not efficacious and/or unsafe) is a bigger gamble for
industry. In other spheres the observation would be cause to applaud
industry for its efficiency.
Goldacre should also know that one cause of publication bias
favouring the publication of positive studies is that the journals are
rather less interested in the negative ones. That goes especially for
journals whose former editors most commonly cite publication bias as a
problem. They fail to acknowledge their contribution to that problem.
As far as conflicts of interest are concerned, precisely the same
charge could be levelled at NICE, an organisation whose objective is to
constrain NHS expenditure. Yet few recognise such an obvious bias. I would
expect a study of recent NICE appraisals would show that NICE's estimates
of cost per QALY for new drugs is invariably lower than that of the
sponsors, yet most will blithely assume that the explanation is that
NICE's estimates are correct whereas the sponsors have cooked the economic
data in the same way they cooked the clinical data. But there is an
obvious alternative interpretation, that NICE has an inbuilt bias driven
by its role and underscored by its ideology. Anyone who does not accept
that may be true in at least some NICE appraisals shows just as much bias
as that assumed to apply to industry sponsored studies.
Further, NICE appraisals are not scrutinised with anything
approaching the level of rigour applied to industry sponsored studies by
FDA, EMEA and local country competent authorities.
Competing interests:
Fellow Faculty Pharmaceutical Medicine. Medical Director at a small pharma company
Competing interests: No competing interests
Re: Re: Reporting of trial results: an idealistic dream of a foundation year 2 trainee doctor ...?
As a trained and, to use the current terminology, licensed,
pharmaceutical physician, I am subject to the same ethical
and professional obligations as Dr Warriner is, and I resent the
implication that if I came to give a presentation to his
colleagues, that my words could not be trusted simply
because of my employer. In the 11 years since I joined the
pharma industry, the worst examples of unethical behaviour I
have seen have been from NHS doctors.
Dr Warriner's unthinking attitude, combined with the lack of
professionalism and common manners shown by many doctors to
people from pharma, does little to improve relationships or
interactions between NHS doctors and people from pharma.
Competing interests:
Pharmaceutical Physician,
Fellow Faculty Pharm Med
Competing interests: No competing interests