"Trying to force a financial camel through the eye of a scientific
needle" was the metaphor used to describe the Herculean task of
regulating pharmaceutical companies. This was the view of one witness to last
month's session of the House of Commons health select committee on the
influence of the pharmaceutical industry. The session was an eye-opener,
shedding light on doctors who prescribe medication without having all the
necessary information for that purpose; and on a weak and uncoordinated
regulatory system that enables the pharmaceutical industry to further its
interests without sufficient regard to public health.
The industry's influence has seeped into the fabric of medical life. It has
tapped the worst of human motives-money, power and glory. A megabillion-dollar
global business, it has a Big Brother potency outstripping that of
governments, at which it has been known to snap its fingers as it breaks
safety rules to suit its own commercial ends.
While some pharmaceutical bosses admit freely that their prime motive is
profit, the success of the industry derives from the fostered perception that
it exists primarily as a public good. Many drug reps I have met positively
glowed with missionary zeal as they pursued their personal targets.
Medications are seen as an unqualified good by the naive: one question posed
to witnesses to the committee was: "Does not every new drug on the market
constitute a new cure?" This is a dangerous misconception, and one that
needs to be demolished. The consistent playing down of serious, even fatal,
side effects of drugs has been achieved in part with the collusion of the
medical profession; but the industry's share of the blame is much greater. Not
only were pharmaceutical companies dragging their heels when it came to
reporting side effects to regulators--side effects including rates of suicide
among children treated with certain antidepressants--one doctor witness had
been offered a bribe worth two years' salary not to publish research that
detracted from a company's drugs marketing profile. Other captive doctor
lecturers have found, on glamorous, lucrative promotional trips, that the
payments dry up smartly if they dare go off-company message. Such bribery has
become commonplace.
After the thalidomide disaster in the Sixties, the medical authorities
established a yellow-card system of voluntary reporting by doctors to the
Committee on Safety of Medicines (CSM). It was assumed that, in a caring
profession, the system would work (as it might well have done if it had been
linked with merit awards). But altruism proved a weak motivator. As was
discovered after a Panorama documentary on Seroxat, if you take information
direct from sufferers you get an avalanche of details. It seems that the CSM
(now reincarnated as the Medicines and Healthcare products Regulatory Agency,
or MHRA) is composed mainly of "experts", who have an interest,
personal or otherwise, in the major pharmaceutical companies. Consumers are
nowhere to be seen. The MHRA has become so fused to the industry it is
supposed to regulate that it has lost its own identity, meekly adopting the
rules of commercial secrecy and inhibited by the terrible penalties, including
imprisonment, of disclosing sensitive information. Industry is adept at using
the threat of litigation to suppress even the thought of whistle-blowing.
The effect of the incestuous relationship between the industry and the
government regulator is that negative and harmful side effects are not
disclosed to professionals or the public, even when they are life-threatening;
such as the higher rate of suicide linked to some psychoactive drugs, and
strokes or heart attacks associated with the anti-inflammatory Vioxx, recently
withdrawn.
Distinguished specialists and professors at prestigious institutes, in
pharma-speak called "opinion leaders", are groomed for engagement.
They can earn [pounds sterling]5,000 an hour or more than [pounds
sterling]20,000 a day for delivering a specific therapeutic message, which is
then accepted by the profession as gospel. Often these interests are not
declared. Sometimes they are declared as "non-personal". That means
that their research base is getting industry funding; but that does not mean
freedom from bias--quite the contrary. Regrettably, the number of
noncommercial randomised controlled trials conducted in the UK is minute and
decreasing. The government does not see its way to funding them.
"Ghost-writing" is another wheeze for subtle advertising. The
company sponsors research on its own drug, jealously guarding the data
produced, writes up the results in a suitably favourable manner, and then pays
an opinion leader to put his or her name to the paper. One psychiatrist,
admitting his own speciality might be particularly prone to such inducement,
reckoned that half of the therapeutic papers in reputable medical journals
were written in this manner. Thus, even those doctors--and there are many--who
try to keep clear of commercial contamination are caught in the trap.
If our evidence base is tainted, who is there to trust? Certainly not those
sales reps who come with scientific spin and a sheaf of peer-reviewed papers
as their mantle rather than freebies and offers of hospitality.
Hospitality at many levels is all-pervasive and targeted particularly at
hard-pressed junior doctors, who see no harm in a free bash at a restaurant
after a token scientific meeting. There are rules against this, but nobody
enforces them. The next step up is to sponsor trips to scientific meetings in
exotic places; the Caribbean is a favourite. In my time as a consultant
haematologist, I refused these on principle and paid for myself if necessary;
but none of my speciality colleagues was so squeamish.
Continuing professional education, which is in effect compulsory for all
doctors wishing to keep registration with the General Medical Council, is 90
per cent funded by industry, without which it would wither for lack of
government funding.
In missionary mode, the pharmaceutical industry sponsored disease-awareness
campaigns such as "Defeat Depression", in 1992. The campaign alleged
that one-third of the population was depressed. The message was: identify and
treat--with antidepressant medication. The industry was not remotely
interested in funding treatment by cognitive behavior therapy, a form of
person-to-person talking treatment, which many deem to be more effective than
drugs, and which is certainly safer. The sale of antidepressants rocketed.
There is a sinister feeling that some similar process is at the root of the
rapidly rising diagnosis of attention-deficit hyperactivity disorder in
children and its treatment with Ritalin, a dangerous drug related to pep
pills. Certainly, conditions such as "sociophobia",
"premenstrual dysphoric disorder" and "female sexual
dysfunction" seem to have been manufactured purely as an outlet for drug
treatment. Some companies have wheedled their way into charitable
organisations and patient groups and used them to advertise their products.
The evidence has not yet focused on the global crimes of the pharmaceutical
industry, such as trialling drugs in developing countries under conditions
that violate human rights; intimidating governments with threats of crippling
trade sanctions; and obstructing the sale of cheap generic drugs to poor
countries, such as in the case of anti-HIV drugs and South Africa.
The proceedings of the health select committee were followed with interest
by the public. Good: perhaps this is a sign that consumers are fed up with a
pharmaceutical business that has sometimes disregarded human life.
COPYRIGHT 2004 New Statesman, Ltd.
COPYRIGHT 2004 Gale Group