medical ethics

I may not have seen a pharmaceutical rep for over five years, but still the branded pens they gift to medics continue to infiltrate my house and my handbag. I conciously throw out the drug company pens I find, but they just seep back in: every time I lose my own plain biro, there is another pen somewhere near, in a ravishing colour or with streamlined design, beckoning to take its place.

The reasons why I don’t like seeing drug reps are several. But mainly they come down to this: time is precious, and unbiased appraisals of evidence are better delivered elsewhere. Reps are there to sell, and fair evidence should not need ‘sold’.

But this may not be quite enough. An interesting paper in the Archives of Internal Medicine has examined the effect of exposing medical students exposure to brand logos on equipment – stickers on clipboards or branded notepaper – prior to being asked about the implicit attitudes towards these drugs. The students who had been exposed to the promotional material held higher implicit values for the promoted drug compared with the control group.

There are obvious limitations to this study - it is a single study performed with one cohort of students, and it does not necessarily mean that prescribing is going to vary with the presence of promotional gifts. Yet we don’t know that it doesn’t. Here is a report in Pharmaceutical Field magazine calling on reps to find those ‘rare but lovely creatures’ – GPs who see reps daily. We now have the internet and excellent sources of information. I do not think that pharmaceutical sales reps are needed, or advantageous to patient care. 

A couple of other potential harms bother me. First, pharmaceutical reps are usually highly qualified and very able individuals. They are utterly wasted in being drug reps.  And second, do people seeing their doctor feel any differently for the presence of branded goods in the consulting room?

Margaret Haywood was struck off by the Nursing and Midwifery Council last week. She had secretly filmed patients in the hospital where she worked to document the conditions, which she claimed to have previously reported. These images were subsequently broadcast on the BBC programme Panorama. There has been an outcry from nurses, as well as from some families of patients on the ward, objecting to the penalty. One has described the conditions there as appalling.

Was this fair? Yes. Patient confidentiality is sacrosanct. If you have to break it – and there are few reasons for doing so – it has to be after other avenues have been exhausted.

And lo, the government said, we must woo voters. And they had a great idea: check ups. Let’s not leave them to the private providers. Let’s put them on the NHS. Everybody loves a check up.

The Department of Health sets out its new idea in a policy paper “Putting prevention first – vascular checks: risk assessment and management”. This includes the laudable aim to prevent ‘at least’ 9,500 heart attacks and strokes in a year. It is also estimated that the program could prevent 4,000 people from developing diabetes and ‘detect at least’ 25,000 people ‘earlier’ with diabetes or kidney diseases.

I’m beginning to think that this sounds suspiciously like a screening programme. The publication goes on: the vascular risk assessment programme will enable ‘everyone between 40-74 in the population to have their vascular risk managed appropriately’. Sounds daunting. Millions of people will be need to be assessed, and an enormous amount of healthcare staff time will be diverted. In light of this, one should expect this scheme to have been tested in real world situations with real world benefits in the UK population it is targeted at. One would be interested especially in medium and long term effects. One would also hope that adverse effects and cost efficiency have been examined. Instead, most of the work examining the effects of this scheme has been done through assumptions and modelling scenarios.

Further, because most of the work is intended to be done outside of GP surgeries, medical advice is not always going to be readily available. I cannot be the first doctor to have been faced with an anxious patient concerned that a cholesterol reading performed beyond the surgery has been found to have been marginally, and inconsequentially, higher at a private providers. I would not have wasted resources in needlessly repeating a test, but this is only going to be a small part of the difficulties of this new scheme. Screening tests should be done as part of an evidence-based policy which acknowledges the possibilities of false positives, negatives, and impact of tests on peoples’ lives.

Screening tests are complicated, messy and confusing. Throwing inadequately tested tests at the problem is rarely the solution.

Or perhaps not so much a makeover, but a radical shift in how drug research is decided upon, performed and reported. The suggestions come from Sir Iain Chalmers, who is editor of the James Lind Library in Oxford, and Silvio Garattini, director of the Mario Negri Institute for Pharmacological Research in Milan. Writing in the British Medical Journal, they say that their proposals would not only benefit patients but also industry, which is not winning any prizes for popularity at present.

They are:

1) Patients to be involved in shaping the research agenda – in other words, making sure research questions have resonance in real life and real-world situations

2) Legal requirements for research to be published, including trial protocols, by all (mandatory publication of trial data has had legal backing in the US since late 2007; no such protection for patients currently exists in the UK)

3) Independent evaluation of drugs. As the paper says: “The monopoly that the drugs industry has in evaluating its own products, and the secrecy surrounding this process, leads to biased evidence that is currently only rarely questioned by independent studies.”

4) A requirement to demonstrate “added value” for all new drugs – is this drug better than the current best drug treatment, or does it benefit in addition to it, and is it better than non-drug treatments? Too often, trials are done comparing a new treatment to placebo where there is a known intervention which is better than placebo. This means that uncertainty about how to use it best persists.

The authors say that these would help improve public confidence in pharma, would improve returns from investment in R&D, but could also improve efficiency in other ways. For example: “Tim Mant, a director of a major contract research organisation, has acknowledged how frustrating it is to be commissioned to organise a clinical trial that he knows is going up a scientific blind ally because he has been there previously with another company but cannot divulge information that is commercially confidential.”

I hope that people in the pharmaceutical industry take notice: I would genuinely love to write about the improvements that are being made.

The Joseph Rowntree Reform Trust is today launching a report, “Database State”, which examines the rationale, security and consequences of 46 public sector databases. It is co-authored by Ross Anderson, professor of security engineering at Cambridge University, who is an outspoken critic of government databases.

The results are startling. Two databases, the NHS Detailed Care Record and the Secondary User Service (which holds summaries of treatment and is supposed to be used for administration and research) are given a “red light” rating. This means, according to the report, that they are “almost certainly illegal under human rights or data protection law and should be scrapped or substantially redesigned. The collection and sharing of sensitive personal data may be disproportionate, or done without our consent, or without a proper legal basis, or there may be other major privacy or operational problems.”

When I spoke to Prof Anderson yesterday, he had much to say on the subject, which he has been researching for almost 15 years. He told me that since about 1995, the Department of Health “has focused on driving control of medical records from doctors to government. It [the Dept of Health] has behaved as though doctors are impeding progress of the evolution of health”.

In Scotland, there has been one main supplier for computerised medical records – the General Practice Administration System for Scotland, or Gpass. Though the system is government sponsored, Ross doesn’t see this as an advantage. He believes that “it has rapidly fossilised. The only interest in upgrading the service has been to put into practice what the civil service has wanted.”

Anderson was adamant that centralised control is “going to be disastrous for medical records”. He gave me an example from Nuffield hospital in Oxford: “[They] put in the new system – and they found that records were suddenly kept on a remote server rather than locally. The server went down in Swindon, and they couldn’t access any records, and therefore couldn’t do any operations.”

But it is not the logistical minutiae of centralised records that concerns Anderson the most. He is more worried about whether they are a good idea in the first place. “In medicine, you have to make sure that the systems are responsive to needs. This is not like a McDonald’s franchise. Medicine is so complex that you can’t [have a "one size fits all" electronic medical record]. Also, when you look at hospital medicine, there are dozens of little specialities, and each wants its own best of breed system.”

Such choice is not going to be possible under the NHS’s new “Connecting for Health” plan. Anderson is also concerned about the plan’s feasibility. “You can build a system for security, or functionality or scale. If you are very good you can maybe do two out of the three. But not three. A GP centre with 10,000 records can cope with risks, maybe there will be a problem with confidentiality once in a career there. At least it is limited and local. But once you get to 50 million records with a large pool of access to them, you can’t realistically expect them to stay confidential”.

There have already been cases where NHS workers have accessed records they had no reason to look at. The few who fail to respect confidentiality will have access to more records, not less.

Connecting for Health says that it will be hugely beneficial to be able to access a person’s full medical record from anywhere in the UK. Yet you hardly ever need a full medical record in order to receive immediate treatment. If you arrive at Accident and Emergency so unwell that you can’t give your basic medical details, it’s unlikely you’d be able to give your name and date of birth either, so access to your computer health record wouldn’t be possible. The ideal may be to use something like medi-alert bracelts, where specific health information — say, about allergies or life-threatening conditions — is available no matter the state of the patient.

As is, the amount of information that the record plans to hold is so enormous that the record ceases to become clinically useful. So much of the data is simply administrative. But it also means that full — or almost full — medical records become accessible to just about anyone working in the NHS (and note, there are 1.3 million people employed in it).

The new records will be opt-out, rather than opt-in, which I think is immoral. There has there been no decent reassurance from the government that standards of confidentiality in medical records will be upheld. I think Anderson’s concerns are justified — and you can start the process of opting out of central systems by making your wishes known to your GP surgery.

The MB ChB medical degree confers a Bachelor’s degree only. True doctorates are PhDs. However, I am guilty of having the title of “Dr” on my bank card. This was only because I thought it might help me get a (larger) overdraft when first out of medical school. But otherwise, at the hairdressers, school gates, and in the world at large, I am Mrs Married. At work, I generally introduce myself without title and then explain what my job is — ie, a GP. On aircraft, I am most definitely Mrs and will always offer to mind the children while my medical husband answers the call for “any doctor on board?”.

In other words, I can’t quite explain why some people seem to get joy out of calling themselves “Dr” at every opportunity – it’s unnecessary and rarely useful to oneself. But it may be useful for patients. I have pondered this as I have observed signs outside chiropractors premises with “Dr” in front of all the names, and dental surgeries too.

The background to this is one of increasing confusion and blurring of identities of many people who work in healthcare with potentially confusing titles (nurse practitioner, nurse consultant, specialist practitioner, house officer, Foundation Year 1, Foundation Year 2, specialist trainee, etc). Of course, other healthcare workers may have a PhD but not a medical degree and be correct in calling themselves Dr (certainly technically more correct than Bachelor medics using the title). But surely the crux is in making sure patients, who probably have more important things on their minds, have a clear idea about who is who?

The medical colleges and the General Medical Council have been rather quiet on this topic. But the Advertising Standards Authority recently reached a couple of interesting judgments. First, against Wigan Chiropractic Clinic. The advert the clinic placed was found to be misleading, in that it implied that the chiropractors were medically qualified by describing them as doctors. (“Who can a Chiropractor treat? Our Doctors are well experienced at treating everyone.”) There were more complaints also upheld about the clinic, but more on that later.

The other recent judgment made by the ASA was that against a dental surgery  where the dentist had advertised his practice using the title “Dr” before his name. The ASA said that “the title ‘Dr’ before a practitioner’s name should not be used in ads unless the practitioner held a general medical qualification, a relevant PhD or doctorate (of sufficient length and intensity) or unless the similarities and differences between the practitioner’s qualifications and medical qualifications were explained in detail in the ad”.

The use of medical titles shouldn’t be about prestige (and it’s debatable whether ‘Dr’ confers any) or snobbery, but accurate information for patients and colleagues.

More from the Prince’s Foundation for Integrated Health: we should look forward to May, when publication of guidelines with an “integrated approach… bringing together mainstream medical science with the best of other traditions… movement including exercise, yoga, tai chi/qi gong…” will apparently be published.

The PFIH is working with Mind and the Royal College of Psychiatrists, among others, to achieve this aim. I am horrified – the RCP has had (at least, up till now) a strong ethos for evidence-based treatments. I can’t imagine these reputable organisations working directly on guidelines with the pharmaceutical industry, for example, on how to use their products in hospitals. So why turn to the PFIH for “inspiration, understanding and practical tools” on “integrated health”?

Good facilities should be expected in psychiatric hospitals but are nothing to do with “integrated health”. Instead, they are everything to do with treating people well and with dignity. Integrated health is also nothing to do with the occupation which patients may benefit from - woodwork, gardening, crafts – but don’t often get the chance to thanks to the decimation of the numbers of occupational therapists in hospitals and the community.

For several years I have been trying – and, evidently, failing – to suggest that the information that women get about breast screening isn’t very balanced. The problem- as I see it anyway – is that services are geared to get women to turn up for screening. Whereas, I would like services judged not on how many women turn up, but on how many women make good informed decisions about whether or not they want to have screening at all. As we have had more and better research evidence about breast screening it has become apparent that there are, as well as measurable potential benefits, also measurable potential harms. Just like operations or tablets, doctors should be explaining the pros and the cons, and trying to help people reach a decision about them. (And Gerd Gigerenzer is the master on explaining risk – his book Reckoning with Risk is brilliant.)

So, in the BMJ this week is a vastly improved information leaflet about breast screening, written by the Director of the Nordic Cochrane Centre and his colleagues; it’s available here.

I forgot to include a link to the paper – the start of it is here.

The EU Medicines Directive has decided that Orlistat, a weight-loss drug, can go on sale over the counter. You’ll be able to buy it without a prescription from pharmacies, and online. The difference between the over-the-counter version and the prescription variety will be the dose: the usual prescription strength is 120mg three times a day – the OTC product will be 60mg.

Is patient choice and increased availability a good thing? All drugs have side effects, and Orlistat – or Alli as the OTC version is to be called – is no exception. The side effects are mainly to do with bowels and incontinence – I will spare you any more detail. Still, it seems to suit some people, and there is evidence of benefit. How much benefit? The majority of studies on Orlistat have used the 120mg dose. Most trials also involved people being given stringent dietary and exercise advice. In trials, people taking Orlistat – with these provisos in place – have lost about 2kg-5kg more than people taking a placebo.

The problem is that we won’t know if this OTC development will work or not. As far as I can see, no one is looking into whether it will make a measurable and effective difference to people’s weight under these lower-dose and real-world conditions.

The other problem is fragmentation of care. The fact that more people are becoming involved with a patient’s healthcare without shared notes makes me concerned that we are creating problems-in-waiting. Shouldn’t we get this sorted out before even more drugs obtain an OTC licence?

I am dismayed to note that complementary therapists are now able to register with the CHNC. Ben Bradshaw, the health minister who is also so keen on the non-evidence based ‘iwantgreatcare.org’ doctor-rating website, is reported as saying:  ”I welcome the opening of the Complementary and Natural Healthcare Council (CNHC) register…which the public can turn to for help. Members of the public who use these therapies will be able to check whether the practitioner they’re seeing is registered with the CNHC. If they are, they have the reassurance of knowing that they have had to meet minimum standards of qualification … Practitioners too will benefit by increased public confidence. Public safety is paramount. Registration, whether voluntary or statutory, is about protecting patients, and I am pleased to see this important milestone in voluntary registration.”

This is nonsense. What about protecting the public from ineffective interventions? Or false hope, wasted time and effort or indeed, potential harm? What is the point of improving “public confidence” in things that don’t work? (And “alternative” therapies which do work are taken up into orthodox medicine.)  Bradshaw would be serving the public far better by advising them to be cautious when engaging with healthcare interventions which have not been proven to work. Isn’t that the best way to “protect” patients? And, incidentally, Bradshaw’s signing off line — “People should always seek their GP’s advice to ensure that any other therapy they use does not conflict with orthodox treatment” – is the epitome of weasel words: how can a GP ethically end up taking responsiblity for things he or she doesn’t prescribe or suggest?

Margaret McCartney’s Blog

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