Doing nothing

March 19th, 2010 by Ben Goldacre in bad science, big pharma, competing interests, conflict of interest, doing nothing, evidence | 53 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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53 Responses



  1. bravante said,

    March 20, 2010 at 1:24 am

    Ben,

    The answer to you posting is that homeopaths have been doing this for years, with the added benefit of not increasing antibiotic resistance.

  2. Ben Goldacre said,

    March 20, 2010 at 2:19 am

    Bravante: no. Homeopaths prescribe sugar pills and foster dependence on their service, which is disempowering. What I describe above is GPs empowering their patients with information alone, the polar opposite of your quack pill friends’ business model.

  3. isitmedicine said,

    March 20, 2010 at 5:24 am

    Lol but that is the answer to you posting!
    Spectacular fail, Bravante.

  4. Andy Graham said,

    March 20, 2010 at 7:08 am

    You’ve got to hand it to the quack pill people though, a response at 1.24am shows determination to be at the top of the comments board. Perhaps next time Bravante should avoid the Friday night piss up so as to maintain a level of perspective. Even a homeopath can’t claim to be the answer to the whole post, surely?

    With regard to the anonymous letter, I have also heard branding consultants speak of the Nurofen target symbol and how customers are more likely to think the product works more effectively than genetics because of it (sorry, no reference for that). I’m sure that pleases Reckitt Benckiser no end.

    I think most of your post (about the misbehaviour of big pharma) is just further evidence of the need to address the commercialisation of medicines. Clearly some of us see an ethical dilemma in charging for medicines whatever the market will bear, denying access to those who can’t pay and using “disingenuous” advertising techniques like anonymous campaigns. These techniques (to a lesser extent with the advertising) are more acceptable when used on any other commercial product, so perhaps the answer should be that medicines should not be commercial products, but then how do we encourage innovation without financial reward?

    In the above definition of “acceptable”, of course, I exclude the falsification of evidence which is wrong even if you’re Rentokill.

  5. Andy Graham said,

    March 20, 2010 at 7:09 am

    Generics not genetics, iPhone fail :-S

  6. greg.m said,

    March 20, 2010 at 9:39 am

    What about the financial pressure that the stated study’s results indicate that there is for a GP to prescribe antibiotics for sore throats? Or does the UK system somehow avoid that?

  7. Wonko said,

    March 20, 2010 at 10:44 am

    Re “Patient given Seroxat substitute felt unwell within two days”, I have seen several complaints over the years about withdrawal symptoms resulting from pharmacists replacing a branded antidepressant with its generic equivalent.

    I suspect that this is due to the quality control issues around generic drugs, particularly the lack of appropriate import controls and the growth of counterfeiting. The state relies largely on Big Pharma to police these matters, and while they actively police the import and counterfieting of their brands, they tend not to give a damn about generic drugs.

    While I think much of the Seroxat scares were an invention designed by US lawyers to pursue class actions against GSK, I am sure that a (very) small proportion of Seroxat users face a risk of suicide as a result of withdrawal (incidentally, the same is true for most antidepressants, including the older tricyclics). As such, there is something in the complaint raised in the Times.

    While it has to be right that GPs prescribe generic drugs in the first instance (can their computer systems not be set up to default to prescriptions for generic drugs for new prescriptions?), it must also be right that once a patient is taking a drug that carries serious potential risks on withdrawal, that the patient should stay on the same drug (even if there is a cheaper equivalent).

  8. jwm said,

    March 20, 2010 at 11:23 am

    Greg m:

    In the uk there is no financial benefit from prescriptions for GPs, the opposite in fact with practices given a prescription budget, which, if underspent, the practice can invest in other services they provide. There is also no incentive in encouraging repeat visits as practices are paid per registered patient on their practice list, not per visit. The except in Darzi’s polyclinics, which is only one of their many epic fundamental flaws.

  9. jobrag said,

    March 20, 2010 at 12:09 pm

    Ben
    What is your position on GPs knowingly prescribing placebos?

  10. Chris Nedin said,

    March 20, 2010 at 12:29 pm

    Generics contain exactly the same active ingredient(s) without the brand name and hence a much lower price.

    Australia has had generic substitution by the pharmacist as standard for several years now. The pharmacist will ask if you would like a generic if one is available. The doctor has to tick a box on the prescription in order to stop substitution, so it’s an opt-out strategy (the doctor has to intervene to stop substitution rather than intervene to allow substitution).

    We haven’t been inundated with patients being harmed by generics.

    Pharma companies hate generics because they undercut the price they charge for brand-name drugs. Under the Australian Pharmaceutical Benefit Scheme, when a generic enters the Scheme, all drugs in that class fall to the cost of the generic. E.g when the first generic statin enters the Scheme, the price the government pays for all statins will fall to the price agreed for the generic. Branded statins can claim a brand name mark-up of a few dollars, but this will still be much less that the original brand price, but the pharmacist can then substitute it for a generic

  11. Sili said,

    March 20, 2010 at 5:35 pm

    I’ve been of ADs for about three years. In that time I’ve recieved at least five different brands of citalopram (likely more). It’s required of the pharmacies here to ask whether one wants the prescribed product or the cheapest available generic. Initially I made sure to switch slowly from one to the other, but it makes absolutely no difference and now I just finish a packet before opening the next. This was the case for Mirtazapine as well, when I took those (I only need those for about a year).

  12. Sili said,

    March 20, 2010 at 5:40 pm

    Generics contain exactly the same active ingredient(s) without the brand name and hence a much lower price.

    Well, they’ve also done away with a research division* – and, more importantly, advertising – big savings there. They only really need QA and QC.

    *Admittedly this by now almost true of Big Pharma™ as well.

  13. gammidgy said,

    March 20, 2010 at 6:08 pm

    To jobrag: Check out this video of Ben in which he gives, I think, a spot-on argument against precribing placebos.
    www.youtube.com/watch?v=wsFTgirKXHk

  14. CoralBloom said,

    March 20, 2010 at 6:17 pm

    I’d love to see the media using their need for ‘fair balance’ to tell us who instigates these campaigns.

  15. bravante said,

    March 20, 2010 at 6:19 pm

    @ Ben

    “the polar opposite of your quack pill friends’ business model”

    Not friends of mine, thank you. In any case, there is this notion that there is always a pill that it is going to make you better and/or show that your health provider cares. Besides, I think the empowering/disempowering discussion depends on where you stand.
    Great blog, by the way, and plenty touchy followers….

    @Andy Graham

    “quack pill people though, a response at 1.24am shows determination”

    Well, it depends where you are, right? being 7 times zones behind the UK makes a difference. And why pill people? I truly believe that MDs also prescribe too many pills.

  16. Guy said,

    March 20, 2010 at 8:01 pm

    Wonko,
    you ask “can their computer systems not be set up to default to prescriptions for generic drugs for new prescriptions?”.
    Currently generic prescribing for GP’s in England runs on average at about 92%. The two major clinical systems do default to generic but obviously this can be overriden by the GP.
    The 8% gap of non-generics is also less than it looks as some epilepsy and heart drugs must be prescribed non-generically. In addition, some combinations are only available from one manufacturer eg many oral contraceptive pills, so it makes no difference whether generic or not.
    So generics are pretty widely used. A few aberrant GP’s and GP’s who also provide the medication through an in-house pharmacy are the main problem here.

  17. SimonW said,

    March 20, 2010 at 10:19 pm

    I know some thyroid patients have a concern that switching brands may be absorbed differently which might lead to a different effective dose. The desire here is to have consistent dosing, so as avoiding the need for additional blood tests, and dose adjustments.

    Given variability in absorption of levothyroxine sodium under normal conditions it seems unlikely the variation between preparations would make much difference.

    Although this was a concern that ran mostly in the US when the largest supplier was concerned that switching to cheaper alternatives would undermine it’s market share. It can be hard to disentangle the truth from what powerful companies want you to believe sometimes, especially when there is a little truth to the “lie”.

  18. Andy Graham said,

    March 21, 2010 at 8:46 pm

    @bravante

    My apologies. I was in a funny mood. I did not intend to seem touchy. I also take your point about time zones (der) and hope you will forgive my anglocentric time perception. I must admit though that your original post still seems to me to have been in favour of homeopathy, even if only for its use as a placebo.

    With regard to your most recent post, I disagree that it is “about where you stand”. An empowering treatment would be one that allows you to treat your illness and understand the treatment. In this particular case the understanding of the treatment provides the further benefit that next time you won’t even visit your doctor for a sore throat, because you will understand that it is usually viral and will run its course. In contrast (no matter where you stand) homeopathy would only work by convincing you that a treatment which has no pharmaceutical effect in fact has such an effect. This is disempowering because it leaves you relying on sugar pills as a treatment for sore throats.

    Incidentally, I agree that many GPs probably overprescribe some treatments. I kind of thought that was one of the points Ben’s post was making..

  19. mikewhit said,

    March 22, 2010 at 10:07 am

    If we are all so in favour of generics, why do all the parents of small children that I know use a well-known brand-name paracetamol suspension rather than the pharmacists’ own-brand gloop at around half the price ?

    Or does it mostly work on the kids by placebo – see the bottle, taste the flavour, feel better ? Though obviously that won’t work for antipyretic properties …

  20. skyesteve said,

    March 22, 2010 at 12:42 pm

    @andy graham – “over-prescribe” is a pretty blunt term to describe a pretty complex process. Why GPs prescribe and what they prescribe is governed by a whole host of issues and has been widely researched and reviewed in the medical literature. Inevitably many of these papers are qualitative but they are interesting nonetheless. For example, a paper from New Zealand that was in the BJGP in 2002 (Br. J. Gen. Pract.,52 (478): 381 – 386)suggested that lower prescribers were more experienced doctors who found it easier to refuse prescriptions and offered more education and counselling instead. Higher prescribers were found to be more motivated towards medicine (or at least a “medical model”) and they felt that patients regarded prescriptions as the provision of service.
    Cost remains a secondary factor to most GPs – if they find a drug that “works well” they keep using it.
    So has there been unnecessary over-prescribing in the past? Yes (though not a patch on vetinary practice or what goes on in agricultue and food industries I would suggest). Is it still happening? Yes, to some extent. But things are definitely changing. For example, more and more docs are getting the message that for things like sore throats and sore ears antibiotics are at best a waste of time and at worst potentially harmful. It will take time but things will change as evidence ecomes clearer. And already, as mentioned, we have very high rates of generic prescribing in the UK.

    @mikewhit – parents prefer branded paracetamol because advertising works! Nobody wastes money on TV or magazine adverts for Boots own paracetamol but Calpol is all over the place. Of course, it may taste better too!
    But the real discussion must surely be whether we should be attempting to reduce fever in kids with minor self-limiting ailments at all. I for one am far from convinced that we should.

  21. jazz_the_cat said,

    March 22, 2010 at 1:18 pm

    On the other side of the pond we went through this issue a while ago, and generics are generally fine. It is the same stuff, after all, so if it really is active then it should work the same way. (Occasionally there are a few differences in formulation and that can make a difference in absorption rates etc). Since there isn’t a national negotiation on drug prices here, brand names are very expensive (sometimes 10x UK) and there is a real cost savings going with the ‘off label’ producer.

    I’ve run, as a patient, into the flip side of this where in order to save money the insurance company has wanted to substitute a different drug of the class of agent, say replacing Lipitor (atorvastatin) with another statin drug like zocor (simvastatin) where the levels of side effects or specific activity are different. This is actually somewhat counterproductive as (at least in the US) you need to test liver function far more often with one than the other to monitor for incipient problems. They’ve even sent out disingenuous mails suggesting other statins like avostatin would be good because it’s almost the same name. (really)

  22. three tigers said,

    March 22, 2010 at 1:48 pm

    Generics do have the same active ingredient, but many other properties can be different. They often have different excipients which may alter their dissolution rates and this can have effects on PK (pharmacokinetics), such as Tmax and Cmax (time to maximum concentration in the blood and the maximum concentration reached in the blood). Bioequivalence studies are done to demonstrate the trade name and generic drugs are equally effective on the condition, but I know from personal experience with amlodipine, a calcium antagonist used to treat high blood pressure, that changing to a generic alters the PK. It took a week or two for me not to feel slightly faint if I stood up too quickly around lunchtime.

  23. paulhardy said,

    March 22, 2010 at 1:51 pm

    UK hospital pharmacies have operated generic substitution for at least 25 years with very little in the way of problems. Hospital pharmacists have always retained the proprietary versions of certain high-risk products including such things as antiepileptics, insulins and, historically, digoxin.
    There are sound pharmacokinetic reasons for thinking that paroxetine may be more likely to produce withdrawal effects compared to other antidepressants. Wonko is right that withdrawal syndromes are possible from any class of antidepressant — although I am more skeptical than him about actual suicidality.
    In 15 years of mental health pharmacy I have not seen any issues of withdrawal precipitated by switching to generic paroxetine.

    @mikewhit, skysteve;
    parents mainly use proprietary paracetamol in small children because they are prepared to swallow it! Generic versions are undoubtedly equipotent, bioequivalent etc etc, but many children will simply say they “taste nasty” & spit them out. My previous hospital chose to avoid certain brands despite their cost benefit because of the number of children who didn’t like the taste (possibly auto-suggested by the nurses’ own prejudices, I don’t know…).

  24. mdimmick said,

    March 22, 2010 at 2:14 pm

    @Wonko:

    Manufacturers of generic drugs for sale in the UK must be licensed the same as brand-name manufacturers. Both are licensed by MHRA. I’d be highly surprised if a licensed pharmacist knowingly acquired a generic medicine from the list of licensed medicines from an unlicensed manufacturer. I’d actually expect counterfeiters to concentrate on brand-name medicines, not on their generic equivalents – and the list of Drug Alerts at the bottom of this page appears to bear that out.

  25. wabsnasm said,

    March 22, 2010 at 4:07 pm

    @mikewhit (#19)

    If we are all so in favour of generics, why do all the parents of small children that I know use a well-known brand-name paracetamol suspension rather than the pharmacists’ own-brand gloop at around half the price ?

    I would gladly buy the generic gloop, it’s either not available (local general shop) or I have to search it out on the shelves (supermarket / chemist). Walking round with a toddler and a buggy, familiar packaging is a magnet for my eyes and lets me just grab it off the shelf.

  26. NeilHoskins said,

    March 22, 2010 at 4:16 pm

    Do generics have a less-pronounced placebo effect than branded drugs? (Serious question.)

  27. MartinYoung said,

    March 22, 2010 at 5:03 pm

    My education in this regard is that many generic factories are incapable of producing drugs with similar bioequivalence and efficacy.

    And that the companies dealing primarily in generics are at a lower level of the “scum-sucking bottom feeder” scale than the ethical companies.

    (“Worse” is toward the bottom of this scale. It wouldn’t make sense to say “higher” in relation to “bottom feeder.” You get my point.)

    And that it doesn’t matter if the generic is going to be sniffed up your nose for allergy, and forgotten more often than not.

    It does matter if you have meningococcal meningitis and only several hours of therapeutic window to save your life. Ethical drug for me please!!!

  28. Andy Graham said,

    March 22, 2010 at 5:48 pm

    @sky_steve re: overprescribing

    I qualified my comments so as not to imply that ALL doctors overprescribe ALL medicines. I was not criticising but alluding to a fairly well accepted concept, that it has been the tendency of GPs (in the UK) to overprescribe certain medicines in inappropriate situations, such as antibiotics for colds. This seems (in my experience, at least) to be being addressed by GPs themselves as an ongoing process. It is helped by the fairly pervasive meme that it’s useless to take antibiotics for colds.

    Re: CALPOL (I’m not clear why we can’t just write the name, this isn’t the BBC)

    In my house we buy both. We know that generics are no different than the proprietory medicine. We don’t much care. The costs for CALPOL vs generic are negligible for our household. We buy the first thing we see. I suspect there is a placebo effect merely from the labelling and I alluded to a similar NUROFEN thing in my earlier post, but then that is in part the result of marketing to patients (which seems to be allowed for OTC painkillers) and is a very good reason why we should not adopt the US policy of allowing advertising for prescription medication to patients.

    Incidentally, well done Congress. I am sure many people on both sides of the argument will one day be glad of the safety net universal healthcare provides.

  29. Andy Graham said,

    March 22, 2010 at 6:45 pm

    Just read the comment before my last one. Now I know that MartinYoung didn’t just refer to pharma companies as “ethical”. Anywho…

    I’m not clear on why it is unethical to manufacture medicines you didn’t invent once it is legal to do so. I don’t require that the man who makes my laptop invented the x86 processor, or that the person who sells me instant coffee invented freeze drying. All I require of them is that they make the product well and sell it at a reasonable price. And it’s a good thing too, because if all laptops were IBM laptops they’d be more expensive. Generics are good for patients because they are cheap. Generics manufacturers keep their drugs cheap by keeping their costs low (e.g. by focussing on manufacture instead of research).

    Oh and I’m not buying the argument that generics are more dangerous, otherwise it would be in the interests of government, the people and several large pharmaceutical companies to have those generics banned and their manufacturers prosecuted. Rarely is something in the interest of all three without action being taken with rude haste.

  30. fence-sitting-bird said,

    March 22, 2010 at 10:18 pm

    @Neil, comment 26 – there’s something in Daniel Moerman’s book on pill colour affecting placebo response, so wouldn’t seem surprising if branding did similar.

  31. ola said,

    March 23, 2010 at 6:18 am

    I think there is another aspect of generic substitution which has not been mentioned so far: confused patients. At least this has been debated somewhat in Sweden, which uses the same type of opt-out strategy as was described above for Australia. Apparently, what has happened in some cases, is that the pharmacist has replaced a branded drug with a generic without communicating this clearly enough to the patient. This would be a problem mostly for elderly patients, who might be slightly confused to start with, and who use many different drugs.

    Having said this, clearly I am in favour of generic substitution, and the above issue should be avoidable. What is required is an adjusted and improved working scheme at (Swedish) pharmacies.

  32. DrJG said,

    March 23, 2010 at 8:07 am

    @paulhardy, @ola

    I agree with Ola that there can be issues with confused patients – and they do not have to be very confused to fail to keep up with drugs which change sometimes from month to month. More and more community pharmacies are run by big chains which spend a lot of time in sourcing whichever version of a drug is cheapest at that moment. When I was a medical student quite some time ago now, we were taught how difficult many perfectly sensible patients find to remember to take more than two or three regular medications – and these were the days before mass-prophylactic prescribing and the expectation to treat every risk parameter to target. I cannot see how repeatedly changing the name, packaging and appearance of medications can do anything but add to these difficulties.
    I certainly have personal anecdotal evidence of patients taking the remainder of one generic drug together with the new supply of a different version of the same drug – fortunately, none of the cases I have been aware of have led to any significant harm, but these were not the most confused patients on my book – more often, they have been the very eager-to-please and to do exactly what the doctor “says” without questioning type.
    And Paul, I do not believe that hospital pharmacy experience can reliably be applied to community use. Apart from the week or two of pills given on discharge, most hospital drug administration is done by trained staff on the wards. Even that is far from foolproof, as various surveys have shown low rates but high total numbers of administration errors in hospital practice, others have shown similar errors in nursing homes and care homes – where the staff will not have any medical or nursing qualification.
    I certainly only have contempt for newspaper letters written by pr companies, and a pretty low opinion of those who let their names be put to such things. But I am still far from convinced that generic prescribing is the trouble-free panacea that some claim it to be.

  33. DrJG said,

    March 23, 2010 at 8:13 am

    @neilhoskins, @fence-sitting-bird

    Can’t remember where, but not long ago I saw an interesting item, though it barely classed as serious research. They took a team of rugby players, all of whom, on questioning, claimed that generic Ibuprofen was just as effective as the branded version. They then tested the effect of a generic by timing how long they could keep their arms in a bucket of ice, before and after the ibuprofen. As expected, they managed longer after the drug.
    They then repeated the test some while later, but with branded ibuprofen, same dose. They found a bigger improvement after dosing with this, despite the subjects’ stated beliefs on generic vs branded drug.
    What does it all mean? Dunno, but I certainly found it interesting and would be interested to see if it is reproducible.

  34. mikewhit said,

    March 23, 2010 at 10:00 am

    “whether we should be attempting to reduce fever in kids with minor self-limiting ailments at all” – once the temperature hits 39.5 I would say Yes ! “Minor self-limiting” is only known in hindsight.

  35. paulhardy said,

    March 23, 2010 at 1:38 pm

    @MartinYoung – I believe your “education in this regard” to be erroneous. Bioequvalence testing forms part of the marketing authorisation for generic products. The bottom feeder argument also ignores the fact that many proprietary manufacturers (with bona fide research departments) have their own generic manufacturing arms – are they bottom feeders?
    Meningococcal meningitis seems a very poor example to quote; treatment involves hospital admission and parenteral therapy with eg benpen or cefotaxime. The issue of bioequivalence and interfering excipients is of necessity hugely less significant, especially when you’re potentially looking at plasma concentrations ~25x MIC (OK let’s not get into blood-brain barrier issues here – you get my point).

    DrJG – I accept your point about patient confusion, although with the proliferation of one-stop dispensing, supervised self-administration, and the variety of environments which hospital pharmacies supply today the idea that hospital practice is irrelevant to the community situation is perhaps not absolute. But the letter to the Times expressly covered issues of generic bioinequivalence, and I argue that 30+ years of hospital experience shows that this can be overstated. And what’s more, the group responsible for the letter have produced a whole raft of arguments in their longer consultation response which would apply equally well to generic prescribing, so what’s the deal?

    Administration errors in hospitals and care homes have as you say been widely studied, and the causes are multifactorial. However in all of the reports the only influence of generic medication highlighted is the problem of house-style packaging which fails to distinguish, say, HonestJohn Generic’s bumetanide from its levothyroxine, for example. And packaging is hardly an issue specific to generic substitution.

    Of course we have had some poorly-made generics; Kent Pharmaceuticals’ mid-1980s flucloxacillin syrup is a painful memory for example. But these are the exceptiion. And given that the proposals will exclude certain medications, and that an exemption for the prescriber will be provided, what has really changed from generic prescribing?

  36. MrPaul said,

    March 23, 2010 at 4:44 pm

    @ Andy Graham

    Re: CALPOL

    I have always wanted to sell a children’s medicine called PLACEBO, that parent could give to their children for minor ailments. It just needs to be that bright pink colour with a foul strawberry flavour. I am sure that parents everywhere would love it!!

    @ Martin Young

    Ethical Drug Companies vs. Generics? I think you’ll find that most actives are made in China – whether from Big Pharma or Generic companies often in the same factory.

  37. Roberta Wedge said,

    March 23, 2010 at 9:45 pm

    @MrPaul
    Re: “I have always wanted to sell a children’s medicine called PLACEBO, that parent could give to their children for minor ailments.”
    It has been done. A self-confessed mommy has built a product line for kids called Olbecalp, with great packaging and no active ingredients.
    inventedbyamother.com/

  38. Roberta Wedge said,

    March 23, 2010 at 9:46 pm

    That should be Obecalp. Typing backwards is harder than it looks.

  39. reprehensible said,

    March 25, 2010 at 12:27 am

    Yawn, genetic substitution, the NHS has saved most of what it can here and it’s a one off saving, with no hope of long term returns. Parallel imports has more legs Ben and is about conflict of interest and science, (well economics), it boils down to issues about Pharma saying they lose money they could invest in research (and of course PR) and therfore opportunity cost.

    Interesting GP studies are few and far between, because there’s not much money to study them with, I know I’m lookin into doing a PhD!(Incidentally there’s also not much data collected coz a lot of em are effectively private business men and not properly integrated into the NHS)

    I was recently told by a professor of public management roughly 99% of NHS research funding goes on more clinical stuff and only 1% to management. I’ve not checked the figures but if they’re correct then if thats not a scientific conflict of intrest story I dont know what is. Again it’s about opportunity cost and ROI.

    Incidentely a researcher recently told me he had to pay £50 quid a time to get GP’s to answer a questionnaire about the QAF. Your right Ben we are a nation obsessed with pills and healthcare of all sorts really, but its certainly not just pharma that makes all the money from it!

  40. Guy said,

    March 25, 2010 at 8:43 am

    Reprehensible,
    “he had to pay £50 quid a time to get GP’s to answer a questionnaire about the QAF.”

    No he didn’t! GP’s are self-employed business people who generally work 50 hour weeks. If someone sends them a short questionnaire about the Quality and Outcomes Framework (QOF), then they will probably spend a few minute and reply to it.

    If people send a big 6 page A4 questionnaire that takes half an hour then they probably won’t. It’s paying for time. It’s a market decision that your friend made to increase his response rate to something done in their own free time. People’s time has a value you know!

  41. reprehensible said,

    March 25, 2010 at 11:06 am

    Sorry, i should have been clearer about that point which i wrote whilst bored when trying to finish an essay!

    What actually happened was he wrote to 200+ GP’s asking for about half an hour do a semi-structured interview regarding the QOF.(Again I should blog earlier in the day!) He was researching a PhD into P4P in healthcare management. About 5 bothered to write/email/call back saying ok. He ended up having to spend about £2k of research money getting his data.

    I accept that GP’s are self-employeed, work long hours, their time is money, and most of them do try and give back, (some regions better than other). However I would have hoped that the profession would accept that the QOF is already payment enough!

    So that leaves the question if £100 per hr is ever justified, here or at any other time really, including with footballers! The link provides some interesting reasearch into this, and it is peer reviewed.

    www.equalitytrust.org.uk/why/evidence/physical-health

  42. Andy Graham said,

    March 26, 2010 at 8:00 am

    @MrPaul re: CALPOL

    Let me know when you get a distribution deal and I will be first in line. I’ll take the labels off and pepsi challenge that stuff with Calpol and Boots paracetamol suspension. Actually that’s a good idea, we could market placebos for popular OTC medications like cough syrups and painkillers and allow people to do their own controlled trials on their kids! Of course, they’d need kids of similar ages and they’d all have to get ill together, but I think it’s a goer ;-)

    I was just thinking about extending the idea to homeopathy but how would you ever develop a reliable placebo? Surely all water has a memory of something? What if a tiny bit was the active ingredient you were testing? Your placebo would be super strong instead of inactive!!! Perhaps the homeopathy people are right, randomised controlled trials on this stuff is just too dangerous, it’s too easy to OD…

  43. Andy Graham said,

    March 26, 2010 at 8:12 am

    Oh and on the “self-limiting fever” point, one of my kids has had febrile convultions before, which was not cool (pun intended). If you’re a parent and your kid’s temp is high, ignore the fool above and give your kids the paracetamol/ibuprofen they need then call NHS Direct or an ambulance if it doesn’t work (and you’re worried at how high it is).

  44. DrJG said,

    March 26, 2010 at 8:23 am

    @reprehensible

    Guy is right – we get bombarded with questionnaires, surveys, requests for letters confirming that they have been having to take their sick parrot to the vet and all sorts, on a daily basis. This is on top of the tasks of actually trying to care for our patients and wrestling with all that the modern NHS places in the way of that aim, like the IT system.

    To be honest, 50 quid for a survey would hardly merit a glance from me unless I thought it was a really worthwhile project, in which case I would try very hard to do it for nothing – and have done. Unfortunately the more common scenario is of carrying the survey around with me for ages with good intentions until I realise that it is now so far overdue that it is pointless completing it.

    I freely admit that I have had some nice things, and some very useful things, from the pharmaceutical industry (now only a fraction of what was on offer even 10 years ago), but what I get mostly from them is a headache from trying to work out which information from them can be trusted and which needs to be treated with great suspicion. We do not, in fact, swallow every announcement from the drug industry as gospel, years of dealing with government and health authority diktats is excellent practice for that approach.

    Inter alia, this means that I think you should inform your friend that he should be very doubtful as to whether his responses are actually representative of GP opinion, or only that self-selected subset who Are swayed by such inducements. Certainly, a former colleague of mine would probably have done so, and I would hate to think that his attitudes and opinions were in any way a reflection of my own, any more than I follow the current media line that the most corrupt of the current crop of MPs is representative of the whole lot.

  45. mikewhit said,

    March 26, 2010 at 11:12 am

    Agree, Andy Graham (not a former IT admin in Shropshire, are you ?!) plus I sometimes wonder whether some of the anti-vxers reports of “vaccine damage” following a fever after a vaccine could have been avoided by use of an antipyretic at the time …

  46. aaron mullan said,

    March 26, 2010 at 12:08 pm

    Sorry if proofread-by-committee is annoying but I think “choose” should replace “chose” so it reads as follows:

    “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 choose an easy life.”

  47. DrJG said,

    March 26, 2010 at 3:14 pm

    @mikewhit – to confuse the issue further, sadly the evidence is that routine post-vaccine paracetamol Does reduce the immune response generated:

    www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961208-3/abstract

    Bit of a catch 22, then: how do you balance the seemingly large chance of a relatively minor adverse reaction (ie poorer immune response) against a small risk of a major reaction (especially when, though a very unpleasant thing to witness in a child, a febrile convulsion itself seldom does any lasting harm.)

    No, I don’t know what the answer is, I simply raise the dilemma for debate!

  48. skyesteve said,

    March 26, 2010 at 4:29 pm

    @Andy Graham and mikewhit – you take me to task for suggesting that it may not be necessary to use antipyretics in children so I feel I have to defend myself – sorry!
    Fever, of course, is a normal physiological process, the suggestion being that increasing body temperature reduces the optimum condition for bacteria and viruses to thrive.
    The first question is what counts as a fever and when should you be worried? I would call anything over 37.2 a fever but accept that with aural thermometers the cut off point may be a wee bit higher. I would start to worry with a temperature over 38C if under 3 months old and over 39C if over 3 months old.
    What do these kids need? They need an assessment by a qualified health professional to try and exclude serious underlying disease and that is what I would urge any worried parent to do.
    The second question is what will an antipyretic do? Well it will probably make the child a wee bit more comfy but it won’t treat the underlying disease/infection (and may, in some cases, mask the seriousness of the underlying problem).
    But what about the febrile convulsions you mention Andy? Well, yes, these are very scary for parents if they occur (I know, I’ve been there). The mechanism is unclear – are they due to a high temperature or is the rate of rise of temperature more important?
    About 2 – 4% of all European children will have at least one febrile convulsion (which, by definition, occurs between the ages of 6 months and 5 years). The average age is 18 months. Most of these are simple, one-off seizures but about 20% of these children will have more complex seizures (i.e. seizures lasting more than 15 minutes or recurring within 24 hours or associated with focal neurological features or associated with prolonged post-seizure recovery – more than 1 hour). About 5% of the children (i.e. about 0.1% of all children aged 6 months to 5 years) will have febrile status epilepticus – seizure persisting for more than 30 minutes.
    About 1 in 4 cases of febrile seizures seems to have a genetic/familial element. Febrile seizures, by definition, do not persist beyond 5 years of age. There is no evidence of increased mortality with febrile seizures, even in cases of status. There is no evidence that intellect is affected by febrile seizures.
    Febrile seizures are recurrent in about one third of cases – recurrence is more likely if family history of febrile seizures; if first seizure occurs at <18 months of age; and if fever is lower or shorter duration at time of first seizure (in otherwords if there is a lower seizure threshold). The risk of children with febrile seizures developing epilepsy in later life is about 2.4% (compared to a "normal" risk of 1.4%).
    Now the crucial question – do antipyretics reduce the risk of febrile seizures? The answer to that is NO! There is NO evidence that antipyretics reduce the number of febrile seizures.
    Now you're entitled (Andy) to call me a fool if you wish. But given the above and given that this is supposed to be an evidence-based forum would you like to withdraw that remark? If not, then I guess there is little I can do to change your mind and my 20 years experience dealing with sick children will count for nothing…

  49. mikewhit said,

    March 26, 2010 at 6:47 pm

    Dr JG: So given the low proportion of those with a post-vacc temp over 39.5°C, looks like the thing to do is monitor temperature, and only administer antipyretic if temp gets above 39.0°C

  50. frankO said,

    March 28, 2010 at 4:01 pm

    Two points.

    1. Nobody has yet mentioned packaging. I (happily) use a generic proton pump inhibitor, but the brands seem to change with almost every prescription renewal, and each new brand comes with a different type of packaging, never offering anywhere near the ease, convenience and small overall size of the branded drug. Because generic companies are in business to keep costs to rock bottom it seems to me they don’t care about such issues; a pity.

    2. Concerning the very issue of colds and sore throats in Ben’s original post. I now know of two instances (both anecdotal, so obviously with limited direct value) in which someone with a serious streptococcal infection following an initial mild sore throat was held off from proper investigation and treatment until their symptoms had reached an extremely serious level because GPs had been convinced it is almost always unnecessary to prescribe antibiotics for throat symptoms. With every sensible message there always comes the risk that the point will be taken in too black-and-white a fashion by those unable to reason well.

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  52. reprehensible said,

    April 14, 2010 at 4:01 am

    @DrJG

    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!

  53. 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.

    blog.dansimons.com/2013/07/pop-quiz-what-can-we-learn-from.html#gpluscomments

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