Taking medication is, for most men and women, an act of faith supported by self-confidence in – if not understanding of – the trials and approvals that lie behind the launch of every therapy. That puts a special burden on individuals who do them. For the pharmaceutical businesses that will have invested hundreds of thousands of pounds taking their merchandise to the brink of the market, failure is disastrous. The incentive is to be as economical with the data as the guidelines permit. The benefits also develop difficult dilemmas for policymakers who have to make fine judgments about cost and benefit of one particular drug more than one more, and weigh the political employs of a drug that may possibly be of limited advantage to the patient when it is the only therapy offered. The row over antiviral drugs for treating flu raises all these concerns.
The usefulness of Tamiflu and its rival Relenza is a extended-running debate. As we report, on Thursday the Cochrane collaboration, a group of independent scientists which investigates drug effectiveness, releases its meta-evaluation of all the trials – rather than the partial evidence published by the business. They discovered that in the typical outbreaks of flu the drug was developed to ease, it did not appear to do a lot very good. It did not preserve folks out of hospital, and it did not help asthmatic children.
The government has invested much more than £500m stockpiling the medication towards a flu pandemic. On the encounter of it, that was a poor call. Only the politics of public reassurance – to have some sort of remedy rather than none – could justify it. But there is much more to it than that.
The man who recommended the government for the duration of the 2009 flu pandemic, Professor Peter Openshaw, says antivirals did reduce the chance of sickness and death. This is not evidence derived from randomised, double-blind clinical trials, but the professor argues that given that flu viruses are getting to be increasingly virulent, these medication are obviously greater than none. In a pandemic, pragmatism trumps all.
The only way to resolve the argument is suitable science. That means transforming clinical trials, harmonising the way they are carried out. It has took place with malaria medication, and it is happening with HIV. The market have to let entry to their information. Confident that like is in contrast with like, trials can then be subjected to meta-examination, enabling statisticians to drill down into sub-populations to create when a drug performs most successfully.
The protocols surrounding trials require to be streamlined so that in short-lived pandemics, the place a massive cohort is suddenly offered, they can be rapidly authorised, as the new director of the Wellcome Trust, Jeremy Farrar, advised in the Guardian last month. Like all great science, it is an thought with the attractiveness of simplicity.
Drug trials: check match | Editorial
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