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Common sense research

September 4, 2011

The WOMAN trial

UK clinical research is a bureacratic nightmare.  Dozens of regulators can scupper each project and demand changes.  Participants end up reading lengthy information sheets, and signing innumerable forms.  Only the most dogged researchers and patients persist.

For genuinely risky experiments the paperwork may be justified, but for most trials of treatments already in widespread use it delays progress, and in the long run harms patients.   So it’s lovely when common sense prevails.

WOMAN is a randomised trial to see whether a medicine called tranexamic acid can help mothers who bleed heavily after giving birth.   The drug is already widely used to treat heavy periods, so we know it’s safe.  We also know that it works for non-pregnant patients bleeding for other reasons.  But we are not sure if it does more good than harm in pregnancy.  It probably helps stop bleeding, but pregnant women are susceptible to blood clots, and it might possibly increase these.   No-one knows how the balance of risks pans out, so policies vary widely.  Some doctors always give the drug, some never do.  In Sweden they always use it, but I’ve been practising obstetrics in England for nearly 30 years and never have.  We can’t both be right.

Only a randomised trial in many thousands of women can answer the question.

But how can you get informed consent from a woman who has just given birth and is bleeding heavily?  She’ll be exhausted and frightened, doctors and midwives will be rushing round trying to stem the flow, put up drips, X match blood.  It’s hopeless.  If she’s under anaesthetic it’s impossible.  But these are just the patients the trial needs to recruit.

Some people think the solution is for everyone, hundreds of thousands of women, to be told about the trial before they go into labour so they can give permission if they later bleed.   But that won’t work.  Women already have dozens of forms and paperwork to think about in the antenatal clinic.  They aren’t going to consider seriously a hypothetical research question which will probably never arise.

Fortunately the regulators and lawyers who set the rules for trials, created a common sense exemption for just this situation.  If the risks were minimal and the research question sufficiently important, consent could be deferred till the situation had stabilised.   And praise be!  The UK research ethics committee agreed that the WOMAN trial qualified.

We joined about four weeks ago in Nottingham, and it’s working really well.  We’ve already recruited four participants.  Some doctors were concerned when they first heard about it, but nothing is secret.  We tell parents and staff what we’re doing, and if the parents say no, we don’t recruit.  But we don’t waste time wrestling with information sheets and consent forms, and we are honest about it.  We leave all that for the following morning.

So far everyone has understood, and been delighted.   Around the world over a thousand women have been recruited.   More UK centres will join soon.

It won’t be long before we find out whether tranexamic acid does more good than harm, or not.  We can then give it to everyone, or no-one, and many lives will be saved.

Jim Thornton

Read more about the WOMAN trial here

1 March 2012 update – I’ve just been sent these two articles describing people’s views about all this. Snowden2012-Women&PartnersViewsOfEmergencyConsentPPH-VERA-2-MW      Snowden2012-Women&PartnersExperiencesPPH-VERA-1-MW

They aren’t easy to read but I think they are saying that people find the whole thing frightening and are somewhat sympathetic to the approach of letting the doctor decide about recruitment.

The salty, salty sea

September 3, 2011

Is not the same everywhere

Which might be handy one day

I swam in two seas this summer, the Baltic off the east coast of Sweden and the channel off England’s south coast.  The Baltic is much less salty.   The difference is obvious when the first drops enter your mouth; you even float higher in the English Channel.

Amazing.  I had assumed that salinity evened out in the connected seas of the world. Not in the Baltic. It is like a wide river flowing out into the North Sea through the Kattegat. Each year it receives nearly a quarter of its volume in freshwater from the surrounding rivers. It even contains different species that prefer the brackish water.

People have suggested creating a huge freshwater lake by damming part of the Baltic – presumably leaving locks for shipping.   It’s not quite as mad as it sounds.

If global warming, population explosion, and other alarmists are to be believed, freshwater might one day be in shorter supply than energy.  I’m doubtful, but it’s nice to know that just as the Canadian, and other, tar sands set an upper limit on the world price of oil, so damming the Baltic could one day do the same for freshwater.

Jim Thornton

Unbelievable sex

September 1, 2011

Smut by Alan Bennett

Two sex stories by Alan Bennett should be good.  But I laughed at only one.

The problem is the sex.   In The Greening of Mrs Donaldson, a middle-aged widow gets off watching her young student lodgers.  Not just peeping, she sits openly at the foot of the bed as they put on a show, and then lets them off the rent.  I think we are supposed to believe that her other sideline, role playing patients for the medical students in her local teaching hospital, has somewhat disinhibited her.  I wasn’t convinced.  Sure, voyeurism is interesting, but this was so unlikely that the laughs didn’t come.

In contrast the author reading The Shielding of Mrs Forbes on BBC Radio 4 over the last few weeks, had made me chuckle, and had prompted my wife to buy me the book – she knows me pretty well.  A just-married gay man gets blackmailed by his boyfriend, without realising that everyone who matters, including his new wife, already know what floats his boat, and they don’t care a jot.

Bennett’s supposedly comic description of the widow’s mind wandering to domestic matters, as she watches the young ones bonking, just reminded me what an unlikely scenario I was reading about.   But happily married men really do go off and look for a bit of gay action occasionally, so his lugubrious comments on the attendant inconveniences were much funnier.

But maybe that just shows the limitations of my imagination.

Jim Thornton

Alan Bennett. Smut: Two Unseemly Stories. Faber & Faber, London. 2011.  

Equal pay for women

August 31, 2011

On the BBC Radio 4 Today programme this morning, John Humphrys interviewed someone about a recent report claiming that progress towards equal pay was slow, despite women doing the “same job with the same motivation and skills”. For middle grade executives the gap was claimed to be about £14,000 per year.

Humphrys of course went into his typical “soft interviews for leftists” mode, and opined that “it was a crying shame”, “something must be done”, “surely we need more/stronger legislation”, and completely missed the chance to ask whether the differences might be explained by other factors.

How can they persist in a free market?  Can independent firms, with shareholders baying for profits, really fail to see the benefits of employing more women. If we are to believe the report, the women would work just as hard, just as long hours, take just as much work home, but be paid £14,000 less.  That’s £14,000 pure profit every year, for each female executive employed.

Equal pay advocates would have us believe that firms are foolish, and can’t see £14,000 waiting to be picked up.  Perhaps they employ too many men!

But it is far more likely that there are subtle differences in the value to firms of male and female employees, detectable to employers, but not captured in job descriptions.  We all know what they might be.

Most families still arrange things so the man tries as far as possible to develop a full time career, move with his job, and take few or no career breaks.  Most women are happy to take lesser paid jobs, change jobs if their spouse moves, and take career breaks to have children. Not every family is like that, but for most it’s a sensible division of labour, making the most of the biological fact that only the woman can bear children.

We may want life to be different, and perhaps men should take on more household chores, and move for their wife’s career.  But surely a BBC interviewer should at least ask whether such differences might explain the observed pay gap.

Jim Thornton

Electric power line nonsense from Tessa Munt MP

August 30, 2011

Nicely demolished by Colin Blakemore on Radio 4 this morning.

You expect environmental drivel from Lib Dem MPs so it is no surprise to see the chair of their backbench green group, Tessa Munt, resurrecting the old chestnut about electromagnetic fields causing cancer.  

As a result of the global warming scare her constituency of Wells is filling up with windfarms.   If we include the full costs of assembly, service roads, concrete plinths and running repairs, most are totally uneconomic and  probably have litle net effect on greenhouse gases anyway.  But they exist, Tessa likes them, and they need connecting to the national grid. 

Unfortunately she has just realised that this will mean overhead power lines, unpopular with her constituents.  So she’s resurrected some barmy epidemiology, the idea that living near such things might cause cancer.

Serious epidemiologists have all concluded that the association is limited to childhood leukaemia, is tiny, and since there is no plausible mechanism or supporting experimental animal evidence, is likely to be a spurious effect of some common third factor. i.e. the power lines are associated with leukaemia but do not cause it.    Even in the unlikely event that they did, hardly anyone lives close enough to be put at measurable risk. 

Of course such careful opinions are unlikely to convince woolly-hatted greens, or for that matter woolly-headed Lib Dem MPs.   But even they might have been given pause for thought by Professor Colin Blakemore on this morning’s Today programme on BBC Radio 4.  He reminded listeners that they are exposed to stronger electromagnetic fields when they use an electric toothbrush, or sleep near a clock radio, before delivering his killer argument.  Burying the cables, as Tessa wants us to do, would allow people to approach much nearer than they can an overhead one.  Since magnetic fields decrease rapidly with distance from the source, the effect would be to increase net exposures! 

Personally, I’d get on with building nuclear power stations, which really produce a decent amount of power without emitting greenhouse gases, and which require many less cables to connect to the national grid.

If Tessa disagrees, she better get used to overhead power lines.  

Jim Thornton

A “desperately needed” coffee shop

August 25, 2011

Last year the Big Lottery Fund, i.e. a special tax levied largely on poor people, doled out £400K to the village of Caistor in Lincolnshire, to convert an old church to a museum, library and cafe. The BBC naturally approved, and devoted a nauseatingly sentimental episode of their “Village SOS” programme to it on 24 August.

Caistor, population 2,700, is about the same size as my neighboring village of Farnsfield and has about the same facilities – a pub, convenience store, post office, chip shop, pizza bar, and pharmacy.  But the presenter Sarah Beeny seemed to think they were not enough, and made much of the fact that the butcher, baker and another pub had all closed for lack of custom.  She seemed unable to comprehend that the apparently well-nourished inhabitants might have chosen to buy some of their food and drink from nearby supermarkets for a reason.

The grant paid for Charlotte, a dreadful yuppie fashion executive from London to live in the village for a year and move the whole thing along.   A couple of local bores wanted a museum, to add to the 2,500 museums already in England – there’s a hundred in the East Midlands alone, mostly subsidised by the taxpayer because they can’t make enough from admission fees.  No-one thought to question whether we had enough already.

To her credit Charlotte told them that no-one would visit their dreary museum, and that the library, which the local council insisted also moved into the centre, was unlikely to draw in many more.  She suggested building a cafe alongside to entice a few paying customers in, so that’s what they did.   It was a struggle to get the locals enthused, but the grant paid for all the serious work, and the thing got built.   Eventually she persuaded a few locals to “volunteer” to work in the cafe, and a few more to buy her expensive real coffee.

I liked the local councillor who, enticed out by the cameras, good naturedly told Charlotte she was the best looking bully they’d ever seen in the village, and made her cry. It was a telling moment, and good TV.   But I missed hearing the opinion of the local publican at finding a subsidised competitor shaving off his bar food profits!

I’ll make a prediction.  The “desperately needed” cafe will be serving instant, or more likely have failed completely within the year, and the museum will be begging for more subsidy.   I’ll report back.

Jim Thornton

Waterbirth

August 24, 2011

Do it in the bath

In my hospital we’re about to build a new midwife-led unit alongside each of our two consultant units.  Each midwifery unit and each consultant one will have a waterbirth pool – four in total.   At the architects meeting to try to shave costs off the plan, I suggested omitting the pools in the consultant units.  No way!   Women who need consultant level care must have the chance to give birth underwater.

I’m all for natural childbirth, but birth underwater is unnatural for humans.  Perhaps I’m just old-fashioned, and it’s not something I’m going to campaign against, but I think new unnatural interventions should be evaluated properly.  Although there is some evidence that sitting in a warm bath relieves labour pains, actually delivering the baby underwater has never been subjected to a randomised trial.   Of course many thousands of babies have been born this way, and most appear to have done fine, but the history of childbirth is littered with interventions that seemed a good idea at the time, but were eventually shown to be ineffective, or even harmful.

During the meeting we debated labour rooms having shared or single toilets, and someone noticed that the draft plans for the waterbirth rooms had no toilet attached at all. 

“Is that a mistake?” they asked.   

“They do it in the bath!” someone else quipped.  

The architects were shocked, but there were knowing smiles from the doctors and midwives!

Lane rentals for utility companies

August 23, 2011

Long overdue

Ever found yourself fuming in traffic while a water company digs up the road?  If we want modern services, we have to put up with inconvenience when things need repairing, but there must be a way to minimise it.

There is.  Make the utility company pay.  Make them pay by the hour, more for busier roads, more during rush hour, and if they can get it done in the middle of the night, little or nothing.   It’s a brilliant idea, long overdue.   The government thinks so too, and is consulting on it right now http://www.dft.gov.uk/consultations/dft-2011-25.

iGreens have long supported road charging for drivers, to discourage unnecessary journeys and reduce pollution and congestion http://www.igreens.org.uk/privatisation_and_toll_road_stuf.htm.  This is a natural extension.  It will encourage utility companies to do the work quickly, get it done at off-peak times and cooperate with each other to share the costs.  The rest of us can only benefit.

Some of the costs will probably be passed on to utility customers, but not all because there is competition among utilities.  Much of the money raised will go straight to government so voters must insist on concomitant reductions in government taxes elsewhere.

In an ideal world roads would be private, some like the M6 toll motorway already are, and the owners would adjust the lane rentals to take account of the lost income from drivers. Government would simply set the rules and let the market sort out the best price. Until that happy day this is a good first step.

Jim Thornton 23 August 2011

Elderberry and damson wine

August 22, 2011

Winning recipe

I won our village horticultural society’s wine cup at the weekend.   It’s only a small village, with about three people in the wine competition, so it was a modest achievment at best, but I wanted to tell you about my winning entry.

It was a 2010 vintage, i.e. nearly a year old.  I used about 3lb elderberries and 1lb damsons, poured a kettle of boiling water over them, squashed with a potato masher, and sieved the juice into a demijohn – much easier than muslin bags.   I repeated the process in one litre lots, till I’d got a gallon of must, added a kilo of white sugar, a teaspoon of Young’s Super Wine Yeast, and fermented till it stopped.   I racked it twice, and put it in screw top wine bottles – less hassle than corks.

I entered a few other bottles as well – the same recipe from 2009, and various other permutations from elderberry, damson and blackberry, but this was clearly the best.  It really wasn’t bad.  I felt very proud.

But I failed to get anywhere in the marmalade or vegetable categories, so perhaps they were just being kind to me.

Jim Thornton

Social policy bonds

August 20, 2011

Whatever happened to that good idea?

Some years ago an economist named Ronnie Horesh came up with the idea of social policy bonds.  The idea was for anyone who wanted to achieve a particular good outcome, say eradication of malaria, peace in the Middle East, an end to the deforestation of the Amazon, whatever, to issue a bond redeemable when the outcome was achieved.   Let’s say you’re the government of Brazil and you want to stop deforestation.  You could pass laws and pay policemen to enforce them, but you might spend millions and still end up no nearer to your goal.  Or else you could issue a bond valued at say £10M payable when some objective criterion for deforestation stopping had been met.  Let’s say when satellite images had shown no reduction in the forested area for 10 years in a row.

We’ve no idea what people would be willing to pay for such bonds. I guess reversing deforestation is pretty unlikely at the moment so they might only be willing to pay a small amount, perhaps £10,000.   The principle works even if no-one is willing to pay anything.  In that case you just give them away.   So long as you get them into someone’s hands, that person immediately has a financial incentive to stop deforestation.  

The idea is that they will start working to bring it about.   Perhaps they will set up their own private police force, (I doubt it)  invent an alternative to mahogony furniture, start an advertising campaign, or plant trees.   They don’t have to succeed, to make money.  They just have to bring success a bit nearer.  The  bonds can be bought and sold, so as deforestation slows and the £10M repayment gets nearer, their price will rise.

The advantages are enormous.   You’re paying for success, not for failure.   If the outcome never happens the bond issuer has not wasted a penny.   You don’t pre-specify how to achieve success.   Anyone with a good idea can buy the bonds and do their best.   Rewarding only those who succeed, stops wasting money on do-gooders who talk but never achieve anything.   There are enough of them in the world!

It strikes me as a brilliant idea.  I wrote about a special type, climate stability bonds, on iGreens nearly nine years ago http://www.igreens.org.uk/climate_stability_bonds.htm.     But not much seems to be happening.   Horesh’s original site and my little comment still come up top when you Google them.  

I’m puzzled.  Why haven’t billions of pounds of bonds been issued, and why aren’t millions of people working to bring them to maturity?  Come on Obama and Cameron.  Or if they’re too dumb, come on Gates and Buffett.   I’d be happy to chip in a few quid to support a bond for halving maternal mortility worldwide.  I’m sure I’m not alone.

Jim Thornton.  Nottingham.  21 August 2011