Healthy Skepticism Library item: 11223

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goldacre G.
Spectacularly expensive cost of trial and error
The Guardian 2007 Aug 11
http://www.guardian.co.uk/science/2007/aug/11/drugs/print

Full text:

Last week Alan Johnson unveiled his new plan of forcing big pharma to accept less money for the drugs we buy from them. The major companies have responded to this financial threat, very much in the style of rightwing comedian Jim Davidson, by threatening to leave the country. It’s a compelling response: big pharma only get 2% of their revenue from UK sales, but they spend 10% of their research budget here.

So how, in the style of a 1970s super-hero, can the health secretary use science to defeat his opponent? The answer is paradoxical: more bad trials. Bear with me, I’m experimenting here.

It costs £500m to bring a drug to market. Much of that is spent on randomised trials. We have made these trials so spectacularly complicated and expensive that they are beyond the reach of governments, academia, and even small companies: only huge international pharmaceutical corporations can afford to run drugs trials now, and so corporations are in complete control of the information. This is bad, as the problems with Vioxx, SSRIs, and other drugs have shown.

We could whinge about that; or, while they’re all on holiday in Provence with their au pairs, we could castrate the ethics committees, on the grounds – ironically – that they do more harm than good.

Imagine there are two drugs called Sixofone and Halfadozen. Nobody knows which one is better for treating sickitis. The drug companies periodically do trials, but funnily their own drug always seems to come out the best.

In our clinic, the doctor sees 200 patients in a month with sickitis. If she gives Sixofone or Halfadozen to her patients at random, on a whim, as a reflection of her own indecisiveness, then the regulation is the same as for any prescription: give reasonable verbal information about risks and benefits, thus obtaining informed consent, and so on.

But let’s say the same doctor, in a spirit of inquiry, recognises that there is massive clinical uncertainty – nobody knows which of these drugs is better after all – and she wants to test her hunches, rather than simply act on them. Then she’s in trouble.

She could run a speculative little trial, giving 100 patients Sixofone, and compare them with the others on Halfadozen. But she’d be struck off, unless she went through so much red tape that the idea becomes unmanageable.

After passing through the endless obstructive and bureaucratic hoops of the ethics committees, from each and every patient she would need to obtain elaborate written consent, and give huge amounts of information. Remember, nobody knows which is best, and if she wanted to hand over the same drugs, entirely at whim, outside of her “trial”, there’d be no problem. This is a huge double standard, and it costs us knowledge.

But if we ever had a scientist in charge of health, instead of tinkering with payments to big pharma, they would do one simple thing: move hell and high water to collect and collate the best and cheapest evidence on healthcare. First you would give huge amounts of money to the Cochrane Collaboration, which collects and collates data independently on all healthcare interventions, and is quietly one of the most subversive organisations ever to be created, because it blows the lid on false commercial claims.

Doctors waste money by irrational prescribing decisions, so give them clean, clear, accessible information, and that will stop.

But more than that, we are in a unique position to generate data: we have inherited an extraordinary information resource, in this vast monolith of the NHS.

Nobody knows what the best treatment for stroke is, but if we randomised every single new stroke patient in the UK, over one week, into a rough trial, we’d have our answers in a couple of years.

What ethical objection could you have to that; what is more important than finding out what is best for stroke victims? Because the entire health service is like the clinic I described above. Where there is uncertainty, the patients, and their data, are unique national assets: if we can find a way to use them, systematically, efficiently, ethically, as a resource for research and information, it won’t matter about big pharma’s power any more.

But as long as knowledge is expensive, multinational corporations will perpetuate their stranglehold on it, and we will be beholden unto them. It’s just an idea for your cornflakes.

Please send your bad science to badscience@guardian.co.uk