Mark Lawson 

When drugs don’t work

Mark Lawson: If this is pharmacology's 9/11, we'll have to choose between animal testing or more patient deaths.
  
  


News moves fast but there can rarely have been such starkly contrasting front-page splashes as two within 24 hours this week. Tuesday: One pill a day to beat heart disease. Wednesday: Drug trial axed after patients poisoned.

The pills were different, but the shift from the patients' dream (trials of an anti-cholesterol drug seeming to suggest that it more or less allowed patients to start again with a new heart) to the doctors' nightmare (trials of an anti-inflammatory put six healthy patients in intensive care) is huge and instructive.

As the hysteria over the new cardiac-treatment superstar showed, we have become a pill-dependent culture, licensed addicts. Even if avian flu should mutate into a human-to-human form, our calculation is that, if we can keep going long enough (perhaps with antibiotics bought under an online counter), a man in a white coat will soon run down the hill with a cure in a tube.

But, after months of being tensed for H5N1 to bring doomsday through European flocks, improbably it turns out that a more immediate threat to British life came from a previously unmentioned set of letters and numerals: TGN1412, the new drug to treat rheumatism and perhaps leukaemia, which the pharmaceutical company TeGenero was testing at the research unit run privately by Parexel within north London's Northwick Park NHS hospital

The lurid details of the state of the patients (one relative tearfully invoking the elephant man) make the story seem unprecedented but, after centuries of progress, no human misery is truly new. The files are full of wonder drugs that became poison pills (most notoriously Thalidomide), and most cemeteries will house someone who had an unexpected reaction to a would-be cure.

The difference here is that such victims were patients - requiring medical intervention, with the risk it always brings - while the Northwick Park six were healthy volunteers. There has been a steady drip of bile on phone-ins, suggesting that the six were victims of their own greed in taking money for taking drugs, but the more sympathetic and important question is why these men were being exposed to what seem unparalleled consequences.

Unless this mystery turns out to have what we might call a Dalziel and Pascoe solution (outside interference in the trial) or a Constant Gardener one (incompetence or indifference on the part of the drugs company), then the focus must be on whether volunteers now face greater risks in drug trials.

If they do, then the next query is whether the considerable success of animal-rights protesters - reducing the use of primates in experiments, leading to reliance on less physiologically similar mice and rats - has shifted the brunt to the public.

Even if that turns out to be the case, the solution is not to march chimps into clinics. Aside from moral arguments against animal testing, there are also practical ones: numerous well-tested drugs have proved ruinous for humans because, say, mice don't eat grapefruit for breakfast. But if an increase in human testing proves to have contributed to this tragedy, the time will have come for society to decide what it prefers: dead guinea pigs, dead human guinea pigs, or fewer drugs.

The other question is whether Northwick Park will prove to be for pharmacology what 9/11 was to aviation or Paddington to rail travel, in terms of commercial consequences and practical changes. In the sky and on the tracks, consumer confidence (or, at least, tolerance) eventually returned, but the public had to accept new safety restrictions and limitations. This model, though, has very different side-effects when applied to healing. Whereas extended airport check-ins and longer waits at signals are visible, a reduction in the production of new pills would have an impact marked only in funerals that might (and only might) otherwise not have occurred.

The terrible dilemma is that, while post-catastrophe crackdowns in other parts of the infrastructure potentially lead to fewer people dying, a clinical panic might increase bereavements - or rather, which is the real point, keep the toll of death and misery from certain conditions at the level it was at before drug companies entered the laboratory lottery.

TGN1412 was at the heroic edge of medicine, seeking to gain advantage for patients beyond the victories already won by existing treatments for rheumatism and leukaemia. So it is not at all like penicillin (or the dreamed-of cure for human avian flu), which is a remedy for otherwise untreatable conditions.

So unless CCTV finds a malevolent or incompetent interloper creeping between the beds of the triallists, the lesson from Northwick Park is that we are all about to take part in a psychological and ethical trial: forced either towards a greater acceptance of the deaths of patients with chronic conditions, or a higher tolerance of something (more animal testing) or someone (triallists in the developing world) having to die to extend our lives.

And, while it can be no consolation for the families involved in this tragedy, one beneficial consequence might be reduced media enthusiasm for the idea of the "miracle" pill.

comment@theguardian.com

 

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