Why is the Indy shilling for Big Pharma?

When my oldest child was born – 15 years ago… gulp! – my partner and I made a conscious decision that, I’m glad to say has born dividends and has, so I’m convinced, rewarded my son, and his younger sister, who came along later, with something very precious and yet also something that money can’t buy.

That something is good health, and the decision we took was simply that when he became ill, as children invariably do from time to time, we would look to the NHS for help only when it was absolutely necessary; that we wouldn’t be the kind of neurotic parents who go running to the GP to demand a cocktail of potions and lotions at the first sign of a sniffle.

That decision has given us our fair share of sleepless nights over the years, sitting at our kids’ bed-sides managing routine childhood ailments armed with nothing more than than love, over the counter medicines, a bowl/bucket with a quarter-inch of Dettol sloshing around in the bottom, and a wet flannel to keep the fever at bay, but its decision that in the long run has served our children well. My son, in particular, enjoys not just good health but rude health. If he’s unlucky he may succumb to the common cold once a year and the occasional stomach ‘bug’ and the very worst he’s had to put up thus far in his life has been the humble Chickenpox, which, in these days of near universal childhood vaccination, it pretty much the last of the traditional childhood illnesses that regularly does the rounds.

As for why we took that decision, that’s simple. We looked at the advice coming from the medical profession at the time and some of evidence and came to conclusion – the right conclusion in our view – that nothing the medical profession had to offer would serve our children quite so well as a good, healthy and active immune system and that the best, and only way, to achieve that was to let it do its job as much as possible without unnecessary intervention.

All of which brings me to today’s front-page article in the Independent, which, in keeping with its usual practice of eschewing mere news in favour of pamphleteering, has irritated the hell out of me:

Hay fever: the cure and the catch

A once-a-day pill for hay fever that could transform the lives of sufferers is being denied to thousands of those most severely affected because of the cost.

Okay, so this tells us two things. First, its another ‘miracle cure’ story and second that what follows is likely to be almost entirely made up of propaganda and contain the minimum possible news, and especially, scientific content.

The pill, which is dissolved under the tongue, is the first oral vaccine developed for hay fever.

Well, would you look at that. Not is it a ‘miracle cure’ but, heaven’s to Murgatroyd, its an easy miracle cure as well, a paragon of medical virtue insofar as it requires none of that icky and off-putting stuff involving needles, side-effects or surgery.

But the majority of NHS trusts have failed to fund it.

Note the propagandising language here. The ‘majority’ of NHS trusts have ‘failed‘ to fund the drug (the Telegraph are using ‘denied’ to much the same purpose and effect), which appears to tell us both that a large number of Trusts have already looked at the possibility of providing this new new drug and rejected the idea and that by doing so they’re implicitly letting us all down and denying us something that we should have by right.

That’s not, however, the position that emerges a fair bit later in the article:

Peter Anderson, the UK managing director of ALK-Abello, the Danish manufacurer of Grazax, said the “lion’s share” of NHS Trusts in the UK had yet to decide whether to fund the drug. “About 20-30 have reached a decision and about a dozen have agreed to fund it.”

So the majority of NHS Trusts haven’t actually made a decision one way or the other on whether they will make this drug available. After the last round of reorganisations, there are 152 Primary Care Trusts in England alone, so the number in the UK that have reached a decision is considerable less than 20% even allowing for Anderson’s rather vague exposition of current numbers, with anything from 40-60% (so far) deciding to put up the money.

By now, if you’re of a somewhat suspicious disposition (like me) you may be wondering quite where this story has come from, particularly as the construction of the story and the order in which quotations are introduced appears to imply that it may have come from the charity Allergy UK, who are first in line to put their views over – except that it would appear from the charity’s website that they haven’t issued a press release since the end of May, which rather rules them out of the running.

Another possibility is, of course, the conference cited in the article, at which a paper on this new drug was presented only yesterday:

Stephen Durham, a professor of respiratory medicine at Imperial College London and the Royal Brompton Hospital, London, who led the study presented at the 26th European Academy of Allergology and Clinical Immunology Congress (EAACI) in Sweden yesterday, said: “Reducing symptoms and improvement in quality of life are the number one priorities for hayfever sufferers …

Again, however, there is nothing by way of a news item or press release on either the conference website, or that of the EAACI for that matter, that relates directly to this story… and you may have already guessed where this is going next.

ALK-Abello, the pharmaceutical company that has developed this new ‘wonder drug’ and which, incidentally, is one of corporate sponsors of the EAACI conference, appears to be the only source of press information, in the form of two press releases published on its website, yesterday; one trailing its clinical efficacy (which includes a quote from Stephen Durham) and a second which focusses exclusively on claims about its cost-effectiveness:

GRAZAX® significantly reduces the use of symptomatic medication compared to placebo GRAZAX® significantly reduces the time lost from work compared to treating with symptomatic medication alone GRAZAX® significantly increase the number of QALYs compared to treating with symptomatic medication alone

Quality Adjusted Life Years (QALY) takes into account both direct costs (e.g. medication and physician visits) and indirect costs (productivity losses such as time away from work) caused by a condition e.g. allergy. One QALY is equal to one year of perfect health for a patient. The lower the cost per QALY gained, the more cost-effective the medical intervention.

Quality Adjusted Life Years, on their own, measure only the apparent clinical benefit of a particular treatment in terms of the number of years of ‘perfect health’ added to the lives of individuals by the intervention in question and make no assessment whatsoever of the economic benefits of such interventions; those are assessed by means of Cost-utility analysis, which are general expressed in terms of Quality Adjusted Life Years when making health technology assessments (i.e. evaluating new drugs, surgical procedures, etc.).

How this works through in health policy is by way of calculating the incremental cost effectiveness ratio, which is a measurement of change in costs change in costs of a therapeutic intervention (compared to the alternative, such as doing nothing or using the best available alternative treatment) to the change in effects of the intervention and not actually incremental at all, at least not in terms of the standard economic meaning of the word. What happens next is that the ICER for the treatment is compared to a monetary threshold set by policy makers (believed to be £30,000 per additional QALY in the UK) with those treatments that exceed the threshold likely to be rejected on cost grounds.

The problem with all this is that, first, the value and utility of QALYs is open to question and dispute. All of the methods of calculating the weighting in QALYs are to a considerable degree subjective and contingent on the population being surveyed – those who do not suffer from a specific condition, in particular, show a clear tendency to over-estimate its likely detrimental effect on quality of life compare to those who have the condition and such measures have also been heavily criticised for placing a disproportionate emphasis on physical pain and disability over mental health and for failing to take account of social factors, particularly the impact on the quality of life of others, i.e. carers, family members, etc.

Second, one cannot read up on any of this without coming away with the impression that it all seems designed to avoid putting over the ‘bottom line’ in clear financial terms. There’s no great problem in identifying the unit and per patient costs of particular interventions – drug companies want to get paid, naturally – which in this case amounts to £67.50 per month (or £810 per year, if you prefer to think in terms of annual costs) but to a layman the whole system of QALYs, CUAs and ICER’s is, at best impenetrable, and looks for all the world to be nothing more than a prime example of PNOYA economics – that’s ‘Pulling Numbers Out Your Arse’, by the way.

The other problem that seems apparent in all this, writing as a layman, is that it appears, in traditionally reductionist fashion, to be making assessments of the economic benefits of interventions in complete isolation and without regard to the possibility that patients may have more than one health problem at a given time. Its stands to reason that the economic benefits of a new hay fever treatment will differ markedly depending on whether these stem from an individual in otherwise robust health or one with a plethora of other debilitating conditions on top of their allergy, which reinforced the general impression that this is all amounts to something in between bullshit and voodoo.

Of course, I could be wrong and be walking into a right going over from one of more of our noted econo-bloggers, but sorry, that’s how it looks to me.

With the hay fever season at its peak, millions of people with an allergy to grass pollen are sneezing, snuffling and rubbing itchy eyes. Hay fever affects about 20 per cent of the UK population – more than 10 million people – of whom up to one million are so badly affected it interferes with their lives.

What is this ‘interferes’ business? Interferes is hardly medical terminology and tells us nothing at all as to the extent to which hayfever actually impacts on these people’s lives – interferes could be anything from seriously debilitating and life-limiting to simply a bit of nuisance necessitating the odd day off work. In the context of trying to form an impression about the ‘value’ of this new treatment, the verb interferes is almost entirely without substantive meaning.

The new treatment, Grazax, is the first oral vaccine for hay fever developed to tackle the underlying condition rather than the symptoms. Manufactured by a Danish company, and licensed in January, it contains small amounts of Timothy grass and is designed to “recondition” the immune system’s response to pollen in people who do not respond to normal treatment.

Oh good, at last we’ve got to a real fact – not a particularly illuminating one, admittedly, but nevertheless a fact and therefore something of an empirical oasis in a desert of meaningless subjectivity.

According to a study released yesterday, the vaccine can produce a cumulative and long-term improvement for hayfever sufferers. Results presented at an international allergy conference in Gothenburg, Sweden, yesterday showed that the longer the treatment is taken the greater the protection it offers.

A trial in 2,500 patients in 12 European countries and Canada showed it reduced symptoms by 36 per cent in the second year compared with a 30 per cent reduction in the first year. Patients in the trial were allowed to use their usual antihistamines and nasal steroid sprays and the findings showed a 44 per cent reduction in the need for this “rescue” medication in the second year, compared with a 38 per cent reduction in the first year.

Well, that does sound impressive even if this calling standard antihistamines and corticosteroid nasal sprays ‘rescue’ medication is rather over-egging the pudding – those with peanut allergies also carry what is referred to as ‘rescue’ medication with rather more justification for the use of the term ‘rescue’ as in those context it means a self-administered shot of adrenaline to stave off anaphylactic shock, which, if untreated, can be fatal. Not quite the same thing then.

Still, figures of 30% and 36% percent for reductions in symptoms and 38% and 44% reductions in use of ‘rescue’ medication look fairly impressive, even if one allows for the fact that improvements in year 2 of treatment are left than a fifth of those in year one, which suggests the dear old law of diminishing returns may be kicking in, and that there’s no year three data as yet as this appears only to reflect the interim findings of an ongoing five year trial.

Still, as the Indy’s report (and the Telegraph are carrying a short but otherwise near identical report, which backs up the suggestion that there’s a press release lurking in the background) note, about half the Primary Care Trusts who’ve evaluated the drug thus far have failed to fall at the feet of its manufacturer and beg for supplies. Why is that, do you think?

Well, you can get some insight from this report (pdf) by the Thames Valley Priorities Committee, which covers PCTs in Buckinghamshire and Milton Keynes.

In the main efficacy trial, mean daily symptom scores during the pollen season were 2.4 with Grazax and 3.4 with placebo (symptom scale 0-18). In total, 68% of the active treatment group used any rescue medication including antihistamines and topical corticosteroid sprays compared with 80% of the placebo group. Grazax contains allergens to only one type of grass. There is evidence of cross-reactivity with some other grasses, although allergies to other types of pollens (e.g. tree) will not be covered.

Its product licence restricts it to initiation by physicians experienced in treating allergic conditions pending more information on long-term safety

The Committee noted that:

− No data are currently available for use beyond one pollen season.

-Vaccine is a sublingual tablet to be taken daily starting at least 4 months before the hay fever season and continued for 3 years

− Most patients (68%) still have to take antihistamine medication

− There is no experience with children, adolescence and the elderly.

So, in another trial, our ‘wonder drug’ showed a reduction in use of ‘rescue’ medication of less than half that reported by the drug company’s own trials, it only covers one type of grass for certain and although other grasses may get some coverage you’re still knackered when it comes to tree pollen, two-third of those using it still need antihistamines and there’s no safety data on either long-term use or use by children, adolescents and older people.

Not quite such a miracle after all.

Campaigners for allergy-sufferers are now insisting that the new pill be made generally available. A spokesman for Allergy UK said the incidence of severe hay fever was growing but there was a shortage of allergy clinics. Six specialist centres and 32 allergy specialists serve the entire country. “The hayfever season is getting longer and the condition can be very debilitating. This pill is very effective and it should be available. We need to see more funding for it.”

Ah, I did wonder on first reading this if there was anything significant about Allergy UK having a general whinge about the shortage of allergy clinics/specialists but the Thames Valley report has cleared that up by noting that current product licence conditions mean you can only get the drug from a specialist and not from your local GP.

Of course, if the drug is ultimately successful in completing its full safety trials and taken up universally by the NHS then it seems likely that it’ll make its way on to the list of drugs than can be prescribed by your GP, in which case will we really need a shedload of extra allergy clinics and specialists?

Oh, while we’re on the subject of Allergy UK, the charity’s accounts (pdf) make for somewhat interesting reading as well, especially the Statement of Financial Activity on page 8 of the report, which appears to show that it spent £275,000 or so during 2005/6 on ‘trading operations’ which, so far as one can tell amount to some charity shops which generated an income on the year of around £42,000, unless much of its trading expenditure relates to its ‘seal of approval’ scheme which nets it a cool £355,000 a year in payments from companies whose product are awarded this mark.

The hayfever season coincides each year with the exam season. A study released yesterday showed half of children with untreated hay fever suffer reduced concentration, potentially affecting their future prospects.

What did Thames Valley say?

There is no experience with children, adolescence and the elderly.

Not that that makes much difference, of course.

Professor Jean Emberlin, the director of the National Pollen and Aerobiology Research Unit, who led the study, said: “It appears that when suffering from hay fever, children are less able to concentrate on specific tasks. This is a trend that I have previously suspected and heard in anecdotal evidence, and this study offers further evidence to confirm the relationship.

But, the drug isn’t licensed for use with children and adolescents yet and could yet fail safety trials, so all this is irrelevant for the time being, other than, of course, as a means of racking up the emotional pressure in the hope than PCTs will cave in and start buying the drug.

“Often hay fever is trivialised, but this helps to bring it to the forefront of people’s minds, and emphasises the need for parents to take the problem seriously.”

Would the observation that Professor Emberlin appears to be laying on a bit thick here be trivialising things, do you think? After all, the research study cited shows that “half of children with untreated hay fever suffer reduced concentration” which may supports the use of hay fever treatments generally but says nothing at all about whether using this particular product has any impact on children’s concentration over and above that afforded by existing (and much cheaper) treatments.

Professor Pamela Ewan, a consultant allergy specialist at Addenbrookes hospital, Cambridge, and one of the UK investigators on the Grazax trial, said: “The results are quite impressive. It appears safe and it is convenient to take. But we can’t prescribe it because we can’t get anyone to fund it. The problem is the cost and the potential number of patients.”

Note the important corollary that now belatedly enters the fray -the problem is the cost and the potential number of patients.

Treatment with Grazax is recommended to start eight weeks before the beginning of the grass pollen season and to continue daily for three years. In the UK the drug costs £67.50 a month, about £2,400 for the three-year course. The cost of treating the one million worst-affected hayfever sufferers would be £800m a year. Professor Ewan said it was hoped that taking the drug for four months each year over the pollen season would be equally effective, which would cut the cost by two-thirds.

Except that this whole business of taking the drug only during the peak pollen season is not the treatment regime that’s been suggested by its producer and also not a regime that’s been tested, so Professor Ewan’s suggestion is not so much that we cut two-thirds of the annual cost so much as we should spend £267 million a year on a drug treatment for which there is currently no evidence for its efficacy or value when prescribed in the manner she suggests.

The only alternative treatment for severely affected sufferers is a course of immunotherapy injections, which require weekly hospital visits and close monitoring in case of side effects. It is risky, inconvenient and costly, and is limited to a couple of thousand patients in the UK. In contrast, Grazax, does not require injection or attendance at hospital, is safe and can be taken at home. This increases its appeal and the likely pressure on the NHS budget.

Without looking into this exhaustively, one of the immunotherapy options currently available is a drug marketed under the name Pollinex, which does indeed require weekly visits to the hospital to receive each of the four injections that make up a full course of treatment – funny, but the Indy doesn’t mention that. Pollinex is similarly limited to a specific type of pollen – ragwort – and is prescribed only in serious cases where other drug treatments have failed to provide relief and, so far as side effects go, these occur in around 15% of patients, most of whom experience nothing worse than a bit of tenderness and swelling around the site of the injection, although in very rare cases it can trigger anaphylactic shock in individuals with an extreme ragwort allergy.

As for expensive, well judge for yourself – a full pre-seasonal course of Pollinex currently costs £320 for the vaccine, compared to £800 for a full year’s course of Grazax, and if we assume that the Indy’s figures are somewhere in the right ball park, i.e. a couple of thousand people receiving Pollinex injections every year, then the actual cost to the NHS is around £640,000 a year, compared to the project £800 million cost for prescribing 1 million people with Grazax.

By the way, if further comments seem a little strained from this point forward, please forgive me – my bullshit allergy is flaring up something rotten.

Stephen Durham, a professor of respiratory medicine at Imperial College London and the Royal Brompton Hospital, London, who led the study presented at the 26th European Academy of Allergology and Clinical Immunology Congress (EAACI) in Sweden yesterday, said: “Reducing symptoms and improvement in quality of life are the number one priorities for hayfever sufferers … The ongoing trial may also show whether long term remission occurs with Grazax, which would be great news for allergy sufferers.”

Early results from some patients followed up for six years suggest the effects of the vaccine are long lasting. Professor Durham said the treatment was suitable for severely affected individuals in whom other treatments were not effective. “I believe about 10 per cent of the hayfever population, potentially a million patients in the UK, could benefit from this treatment.”

At £800 million a year, and with 68% of people still requiring other treatments on top, I don’t fucking think so…

Peter Anderson, the UK managing director of ALK-Abello, the Danish manufacurer of Grazax, said the “lion’s share” of NHS Trusts in the UK had yet to decide whether to fund the drug. “About 20-30 have reached a decision and about a dozen have agreed to fund it.”

Remember this from earlier? Okay, we’ll move on because the Indy is now going in to helpful mode…

Pollen, pollution and the symptoms that cause misery

* Hay fever is the commonest allergy in Western countries, affecting an estimated 20 per cent of the population in Britain.

* It is an acute allergic reaction to airborne particles of pollen which penetrate the nose, throat and upper respiratory passages.

* Typical symptoms include red, itchy and watery eyes, blocked or runny nose, frequent sneezing, coughing, and wheezing.

* The symptoms are caused by the over-sensitivity of the mucous membrane that lines the inside of the nose, throat and eyes.

* The commonest cause of hay fever is grass pollen. Pollen from birch trees especially causes hay fever in spring and from mugwort and chrysanthemum in autumn.

I’ll pause there for a second to reflect on the fact that neither new miracle Grazax or dear old Pollinex provides treatment for tree pollen, mugwort pollen or chrysanthemum, so if you are allergic to any of those then you’ll still have to keep a hankie a handy and tough it out.

* Hay fever affects many people in towns because of pollution. Pollen grains become attached to particles from car exhausts, increasing their allergy-inducing effect.

Its also thought that over use of antibiotics in childhood may be a contributory factor as this inhibits the development of a robust and effective immune system, which is why I mentioned my kids at the start of all this – neither suffer from hay fever.

* Treatment is mostly symptomatic, with anti-histamines and steroids to reduce the inflammation in the mucous membrane.

What else could the Indy add after all that. Well only the kind of trite ‘human interest’ angle story more usually found in cheap weekly magazines for bored housewives and office workers and those afflicted with an altogether more common and serious problem, congenitial stupidity:

‘I can be sneezing all day in summer’: Lisa Young, hay-fever sufferer, 37

Really? You should think yourself lucky you’re not in ‘Take A Break’ and husband’s not a serial bigamist who’s undergoing gender reassignment after running off with the lesbian dominatrix next door who used to be your best friend.

The first thing Lisa Young does every morning is swallow her anti-histamine tablets in a vain attempt to keep the runny nose and itchy eyes that blight every summer at bay.

“My eyes are the worst, smarting, itchy, continually sore. As soon as I go outside I start to itch. I can be sneezing all day in summer. I have suffered badly for years.”

Awwww… No, sorry. This may sound a bit hard-hearted but you’re still not going to persuade me its worth £800 million a year just to shave a few quid of your Kleenex bills.

Aged 37, she is a teaching assistant in Reading and has to accompany classes outside which can make it difficult to work. Her two children, Jane, eight, and Cain, four, are also affected and under the care of the specialist allergy clinic in Basingstoke.

Ms Young said of Grazax: “It sounds like what I need. If it can ward off the effects of hay fever and is more effective than anti-histamines, then I would be very interested in having it.”

Can’t blame you for that.

“It should be provided on the NHS.”

Houston. We have a problem.

Why should it be provided on the NHS? Or more to the point, at £800 million a year, which NHS services do you suggest we cut – of which taxes should we raise – so you can have an as yet unproven drug treatment that offers limited relief for a non-life threatening condition that, for most people, amounts to not much more than a bit of a bloody nuisance?

Allergies are growing throughout the UK and people who live in towns tend to be worst affected, owing to the pollution interacting with the pollen grains.

Ms Young said she knew many friends and neighbours who suffered in a similar way. “Where we live in the Thames Valley, it seems to be bad for allergies.”

Ohhh shit. This would be the same Thames Valley whose priorities committed has recently decided that Grazax “should be considered a LOW PRIORITY treatment due to lack of evidence of incremental clinical and cost effectiveness when compared to existing therapies.”

Do I get to allow myself a few moments of insufferable smugness for spotting that information when the Indy appear to have missed it, and the chance to play the ‘it’s just not fair’ postcode lottery angle, entirely? I think I do…

…okay, that’s quite enough of that, just one more line to go.

If it is too late for her to have the oral vaccine herself, she would want it for her children, she said. Grazax is not licensed for children, but it may be in the future.

Why on earth would it be too late for her to have this vaccine? Is she planning on dying before it completes its clinical trials or something? Methinks they’ve sent one of the interns out to get cover this bit of the story without explaining to them that this new Grazax stuff is like the flu vaccine that people get every year, not like the TB vaccine or the standard run of childhood vaccinations which are no use at all unless you have your shots before contracting any of the relevant illnesses.

FFS, if you’re going to run a human interest angle, you might at least go to the trouble of not making your subject look a bit of an idiot because you’ve not explained even the basics about how this vaccine works.

Which leaves only the same question posed in the title?

Why is the Indy (and the Telegraph for that matter) shilling for Big Pharma?

7 thoughts on “Why is the Indy shilling for Big Pharma?

  1. Nice work.
    Although why you have decided to write something in which stats, data and the scientific method are all present and very relevant, and then go on and stick your own bit of anecdotal data in, I don’t know.

    But if it’s good enough for you, here’s my anecdote: I would say my upbringing was quite similar to your kids, at school I had a near perfect attendance record, and rarely go to the doctor. I do have hayfever (though fairly mild).

    I think the latest theories for the causation of allergies, particularly hayfever are that exposure at an early age to allergens, through a cut, along with genetic predisposition, is the major reason for thing like hayfever, asthma and eczema (which I had as a child). The strength of the immune system is not massively relevant if that is the case.

  2. I,m with Sam on this one i raised my kids in a similar way to you in the belief that love, good food (breastfed), active lives and avoidance of doctors surgeries would let nature do its thing and provide them with robust health – it has in all respects but allergies. 2 out of 3 have those life threatening nut allergies and a different 2 out of 3 have hay fever.
    For the nut allergy they carry adrenaline.
    There is no disputing the affects of this allergy as you state in your article it is deadly, i am not an over protective parent. For their hayfever they take nothing as i assume that desensitisation to this allergen will occur naturally.
    This type of desensitisation is free and is adapted specifically to the allergens that surround my kids.

    Eventually i will get to the non-anecdotal part – if the drug company gets away with this one there is a huge seam of ignorance to be mined.

    Public understanding of allergy and “intolerances”(thanks Ms McKeith) is so poor, from those that assume i am an over protective mother (no, really she could die) to the children who come over to tea and have been convinced they are allergic to milk, wheat, brocolli, twiglets, the colour red – an inexhaustible list.

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