The influence of big pharma (British Medical Journal Editorial)

April 22, 2005

" Zeus " <info

Fri, 22 Apr 2005 13:51:38 +0100

The influence of big pharma

Wide ranging report identifies many areas of influence and distortion

....he would have us believe that his drug has been discovered by

chemical research of alchemical profundity, and is produced by a

process so costly and elaborate that it can only be sold at a very

high price. 1

A report published last week on " the influence of the pharmaceutical

industry " describes a strong United Kingdom pharmaceutical industry,

whose net exports are worth over £3bn ($5.6bn; {euro} 4.3bn) annually.

2 The industry's declared goal is " to bring patients life-enhancing

medicines, " a goal " not only necessary but noble. " The House of

Commons health committee examined the means used to achieve this noble

end. They found an industry that buys influence over doctors,

charities, patient groups, journalists, and politicians, and whose

regulation is sometimes weak or ambiguous. For example, the Department

of Health, responsible for a national health service that spends

£7.5bn on drugs annually, is also responsible for representing the

interests of the pharmaceutical industry.

The committee described how the industry taints doctors. Over half of

all postgraduate medical education in the UK, and much education of

nurses, is funded by the pharmaceutical industry from its annual

marketing budget of £1.65bn. The Department of Health spends just 0.3%

of this on publishing independent information on drugs. " Key opinion

leaders " may receive £5000 for giving an hour's lecture. The committee

found this surprising. Their report recommends that the General

Medical Council maintain a register of " all substantial gifts,

hospitality, and honoraria received by members. " In this way,

professional self delusion that " marketing does not influence us " may

bring outside regulation.

The industry spends £3.3bn annually on research in the UK, financing

about 90% of all clinical drug trials, but develops few truly

innovative drugs. It influences the interpretation and reporting of

results of trials. Negative results can be dismissed as erroneous

( " failed trials " ), whereas positive ones can be published repeatedly

in different guises. 3 The committee report recommends establishing an

independent register of clinical trials, containing full information

and available at the time of product launch, as a condition of

authorisation for marketing. Registering all trials at their inception

might be better so that " failed " trials can also be scrutinised.

The committee noted that drug advertising deliberately associates

brands with attributes that satisfy the emotional needs of the

professionals—the " strategy of desire. " 4 The report recommends closer

scrutiny of advertisements and limits to promotion aimed at

inexperienced prescribers. It also recommends that medical

undergraduates learn more about clinical trials, adverse drug

reactions, and marketing by drug companies. Unfortunately, clinical

pharmacology has disappeared from many medical school curriculums and

will need active resuscitation. 5 The report also suggests that

marketing and prescribing be limited when a product is first licensed,

to allow experience to accrue. The idea of a probationary period is

attractive, but formal trials of relative efficacy within the NHS

would be better. 6

Companies can only market products if they have authorisation to do so

from the Licensing Authority. The Medicines and Healthcare Products

Regulatory Agency (MHRA) is its executive arm, with an annual income

of £65m derived entirely from licensing fees. The committee thought

that the need to attract pharmaceutical business could conflict with

the MHRA's primary task of protecting the public. They also questioned

the thoroughness with which the MHRA reviewed data submitted for

licensing, and its ability, after licensing, to detect adverse drug

reactions and act on them.

As evidence, the report cites the fact that " only 19 drugs have been

withdrawn between 1993 and 2004, " but " medicines can be licensed in

the absence of adequate data or investigation into possible adverse

reactions... " The MHRA cannot win with this analysis: if it withdraws

drugs, it has failed in the first place to obtain adequate information

to predict adverse reactions; and if it does not, then it has failed

to detect adverse reactions. The committee chose rofecoxib as an

example. We now know from a large randomised trial that this coxib

probably increases the risk of thromboembolism by 1:140 patient years,

less than twice the background incidence. 7 To confirm such small

increases is notoriously difficult. 8 9

The spontaneous adverse drug reaction reporting scheme using yellow

cards is also criticised. Many reactions go unreported, and increasing

their reporting rates would be good. 10 However, spontaneous reports

describe association, not causation, and rarely provide sufficient

evidence for regulatory action. Even with good data on benefit and

harm, pharmacovigilance is rarely straightforward—the US Food and Drug

Administration may yet agree to re-licence rofecoxib. 11 The report

urges greater efforts to investigate signals of possible problems, but

does not suggest how to command the necessary resources. Matters would

improve if the MHRA could require companies to undertake specific

studies as a condition of renewal of a marketing authorisation.

The last health select committee report on the pharmaceutical industry

was published on the day World War I was declared, 12 and its far

sighted recommendations such as the registration of all manufacturers,

remedies, and therapeutic claims, were ignored in the aftermath. The

current wide ranging report correctly identifies many areas of

pharmaceutical influence, and the distortions they introduce. The

report does not identify the resources to assure that an independent

David triumphs over the pharmaceutical Goliath. Unbiased clinical

trials, objective drug data, and perfect pharmacovigilance are

desirable but probably illusory and certainly expensive.

R E Ferner, director

West Midlands Centre for Adverse Drug Reaction Reporting, City

Hospital, Birmingham B18 7QH (r.e.ferner{at}bham.ac.uk )

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