Doing nothing

March 19th, 2010 by Ben Goldacre in bad science, big pharma, competing interests, conflict of interest, doing nothing, evidence | 54 Comments »

Ben Goldacre, The Guardian, Saturday 20 March 2010

I don’t write about stories where someone has a conflict of interest, in general, because there are no interesting scientific ideas in them: such stories are a way for people who don’t understand the technicalities of science to give the illusion of critiquing it. But it’s still disappointing to see companies being so much better at getting media coverage for their ideas than everyday folk.

Last month the government proposed a scheme allowing pharmacists to substitute all prescriptions for branded medicines with the generic alternative. Generic drugs are copies of a molecule, but manufactured more cheaply by another company when the inventor’s patent has run out. In almost all cases they are identical, and where they are not, the scheme allows for exemption. A letter of protest appeared in the Times – a spontaneous protest by doctors and patients – signed by various patient groups and experts, with positive coverage in the broadsheets. “Plan to switch to cheaper medicines will harm patients, say experts”, reported the Times. They even had a case study: “Patient given Seroxat substitute felt unwell within two days”.

But Margaret McCartney, a GP in the Britsh Medical Journal, has dug: in fact the letter was coordinated and written by PR company Burson-Marsteller, paid by the drug company Norgine. Peter Martin, chief operating officer of Norgine, despite being the major influence behind the campaign, did not sign the letter himself. Asked why not, he cheerfully replied: “there was no conspiracy. The frank truth, the honest truth, is that I thought that having a pharmaceutical company in there would sully the message somewhat.”

Meanwhile this week you might have noticed the “stay at home” campaign, covered in the Times, Telegraph, Mail, and BBC, encouraging people not to go to their GP with mild self-limiting conditions. This campaign was organised by the Proprietary Association of Great Britain, which represents the manufacturers of over-the-counter medicines and food supplements in the United Kingdom. I think we’re unhealthily obsessed with pills of all varieties, but the PAGB did at least have the courteousy to sign their own letter, and their case is stronger. But their report missed one of the most fun trials ever published in general practise: a randomised controlled trial of the social phenomena of medicalisation.

Doctors commonly prescribe treatments, even when they know they’re not effective, because in the face of assertive patients, demanding a specific treatment, many will chose an easy life. But does a prescription really reduce workload?

Most sore throats are caused by viruses. Doctors usually avoid antibiotics, as a Cochrane review shows only marginal benefits. Explaining the evidence, and prescribing “watch and wait”. Being told that 5 days is the average duration can also help put your misery in a reassuring context. But measuring the benefits of that empowerment requires imagination.

Paul Little and colleagues took 716 patients, who gave written consent to a “study looking at how quickly sore throats settle.” Patients were randomly given either 10 days of antibiotics, or advice to watch and wait, or a delayed prescription, which they could use if things hadn’t settled in a few days.

Patients got better in each group at pretty much the same rate, as we would expect, and got back to work or school at the same pace. More interesting, though, is that many more patients given antibiotics came away with the view that antibiotics were effective (87% vs 55%), and many more intended going back to the doctor if they had another sore throat (79% vs 54%).

So while prescribing antibiotics had marginal benefits on the sore throat at best, it hugely enhanced belief in antibiotics, and intention to go back to the GP. Then, one year later, the researchers returned to the same patients for a follow up study: and they found, looking back, that patients who had been prescribed antibiotics originally were 39% more likely to go back to the GP when they had a sore throat.

The evidence based medicine journal Bandolier (available free online, and highly readable) summed this up by translating the figures from both studies into what would happen in a real surgery, after doctors’ behaviour changed. “If a GP prescribed antibiotics to 100 fewer patients with throat infection in a year, 33 fewer would believe antibiotics were effective, 25 fewer would intend to consult with the problem in the future and 10 fewer would come back within the next year.” Sometimes the most helpful consultations involve no pill at all.

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54 Responses

  1. qlmycff said,

    April 13, 2010 at 10:40 am

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  2. reprehensible said,

    April 14, 2010 at 4:01 am


    I do sympathise, my dad’s spent a career trying to get IT to work in the NHS, and when I worked as a rep I did my fair share of chasing pointless targets, which frankly got in the way debating the evidence providing a valued servive etc. etc. I ultimately left big pharma for these reasons.

    My point about the QOF was it did pay GP’s a lot of money, so it seems reasonable ask to profession to investigate, scientifically, its effects. i’m sure he knew this would introduce bias into his sample, that was always going to happen, but some research here is better than nothing.

    my wider point however is we’ve come to a point with social medicine where people have to admit some of the resource (especially pharma’s budgets) need to be focused better. There is some Science in Management, even if first principals are much fuzzier and you only have to read Marmots Whitehall study to realise how effective it could be.

    The equality trust studies are really good, and point to the fact, scientifically, that if people really want to help they should create a fairer society. I also suspect many MP’s feel the same. Just as I’ve met many very good Dr’s in the NHS. What’s needed though is better, management and research of this, much more than on the clinical side, which gets a disproportionate amount of resource. Unfortunately MP’s never talk about this, or bring up rationing for that matter!

    However for treating cough, I’d grant medcine some cash money to have a real look at short term mucolytic use, then some more to look at their antioxidant properties in the long term for COPD. I’d want to save some for looking at patient self management though!

  3. Discussant said,

    August 5, 2013 at 10:52 pm

    People should be aware of the massive waste of time and money, and potential for harm and emotional damage, that results from the pseudoscience (quackery), lack of transparency, invalid and hidden trials, etc. in the psychotherapy industry, as well.

  4. Doubting Thomas said,

    December 11, 2014 at 12:08 am

    Are generics really identical to branded drugs?

    The requirement is that the active ingredient must be the same, but the other ingredients can be different, and the requirements on bioequivalence look downright crude.

    Please correct me if I’m making an elementary mistake, but my reading of the MHRA guidelines on bioequivalence is that what has to be demonstrated is: that in a single dose test on 24 to 36 healthy subjects, the maximum concentration produced in the bloodstream (Cmax) is somewhere between 80% and 125% of that produced by the branded drug; and the area under the concentration time curve has to be somewhere between 80 and 125% of that produced by the branded drug.

    So someone could be on a generic from one manufacturer which passed by having Cmax of 80%, then in their next prescription be given a generic from another manufacturer which passed by having a Cmax of 125%.

    FDA rules allow generic manufacturers to keep on testing until they get a successful result, and not report unsuccessful results – not sure if this is the same here.

    That may all be fine with drugs which aren’t particularly dose-dependent, but for antidepressants and antipsychotics it just doesn’t seem safe, eg in the case of say an SSRI with a severe withdrawal syndrome, changing dose by anything up to 45% a month could have severe consequences.