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23 July 2001

How the law keeps us ill

If anybody finds a cure for cancer, it probably won't be used. Our obsession with safety keeps effec

By Michael Hanlon

Gene therapies, the human genome project, amazing new molecules that can zap the blood supply to cancerous tumours – it seems as if medical science is advancing in leaps and bounds. Surely it can be a matter of only a few years before cancer, Alzheimer’s, Aids and the rest are consigned to the same dustbin as smallpox and the plague?

Well, maybe not. Sadly, a paradox is emerging in medicine. While scientific advances are taking place at an unprecedented rate, progress in the doctor’s surgery is rather slower – in many instances, slower than it has been for much of the past century. And the reason often has little to do with funding or expertise, but more with our newfound obsession with “100 per cent” safety and the growing role of lawyers and litigation in modern medicine.

It wasn’t always like this. Penicillin was used on human patients straight after animal trials – which would be regarded as hasty and perfunctory today. Edward Jenner became the father of vaccination only because he was allowed to carry out the dangerous procedure of “variolation” – injecting a human with live viruses – on an eight-year-old boy.

Nowadays, any new drug must be tested, and tested again. Many experts believe that the testing regimens now insisted upon by the licensing authorities have resulted in unnecessary costs and delays. According to Professor Peter Lachmann, the president of the Academy of Medical Sciences, our legally enforced desire that all drugs are completely free of dangerous side effects has, in many instances, gone too far. “The regulatory regimen for drug approvals imposes very high costs for the few lives saved,” he says.

Saving lives costs a lot these days. First, the drug needs to be created, and tested for efficacy. Then, after a long process of testing on animals, the procedure moves to clinical trials on human beings. Then, and only then, can a licence be applied for. In Britain, this is the responsibility of the Medicines Control Agency; in America, it is the job of the Food and Drug Administration. The administration’s concern for safety knows no bounds. Mindful of the Thalidomide disaster in the 1960s, it now insists on tests so rigorous that the introduction of a new product can take a dozen years or more, and cost tens of millions of dollars.

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This has a twofold effect. First, it imposes a huge financial burden on the drug firms, which both pushes up the cost of any eventual product and reduces the number of new treatments on offer. Second, it delays the introduction of drugs that could save lives. This month, the papers have been full of stories about a new cancer drug, Combretastatin, which shrinks tumours by destroying their blood supply. Despite “stunning” success in the lab (with mice), it will be many, many years before this product is available in a hospital near you.

Even after the clinical trials have been completed, drug firms must usually undertake costly post-release surveillance to detect rare complications that might occur. And even after all this, problems can crop up to deny thousands of people an effective treatment for their disease because a few have come to harm. In the late 1970s, the drug Opren was withdrawn after it caused the deaths of a number of elderly patients. The drug was – and is – one of the most effective treatments for the agonising pain of rheumatoid arthritis. But because it was ill-advisedly licensed as a general painkiller, rather than a drug specific to this disease, it had to be taken off the market entirely, rather than being relicensed for use only by specialist physicians.

Fuelling all this precaution is the fear of litigation. Already, patients who willingly took part in trials of drugs to combat Aids have started to sue over the side effects. When the lawyers start to circle, disclaimer signatures are worth far, far less than the paper they are scrawled on. In the 1970s and 1980s, thanks to the threat of litigation, the number of firms willing to produce vaccines dropped to nearly zero. Eventually, governments had to step in and underwrite the drug firms.

In Britain, we may not yet be at the stage reached in the United States, where doctors research, prescribe and treat according to legal rather than medical rectitude, but we are getting there. Take the Alder Hey scandal, for example. That one renegade medic – Dick van Velzen – collected hundreds of children’s body parts without their parents’ permission has resulted in the setting up of the ludicrous “Retained Organs Commission”, whereby relatives will be able to demand bits of their loved ones, years after they passed away. The threat of being sued has prompted this legally dubious move by the government (if all the Alder Hey relatives were to sue, the bill to the NHS could top £300m – the price of a couple of new hospitals). Doctors do not keep dead children’s brains and kidneys for fun. They keep them for research and study. Without these stored post-mortem samples, it would have been much harder to trace the spread and pathology of CJD and Aids in the British population.

Experts acknowledge that there is a problem with litigation, and admit that, when it comes to medicine, logic often takes a back seat. “We can all agree that it is better to see a few people dying than a lot of people dying, but when it is their mother who might be one of the few, people don’t see it like that,” one Department of Health bureaucrat told me.

In the today’s legal atmosphere, human beings would never have set foot on the moon – a jumpy Nasa would be worried lest an astronaut suffer some minor injury in flight. And Columbus would never have been allowed to discover the New World. Although, in retrospect, that may not have been such a bad thing.

Michael Hanlon is a staff writer on the Daily Mail

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