”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 £5,000 an hour or more than £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 non-commercial 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 behaviour 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.