Thursday, 16 December 2010

Stemming the tide of cell therapy stories, or, Where are the Methods and Materials in this journal?

Thanks and hat-tip to the outstanding blogger @gimpyblog, who Tweeted the story in the Sun on which this post is based; thanks also to the brilliant @stephenemoss for encouraging me to write this post; and apologies for the headline...
Time after time bloggers criticise newspapers - mostly but not exclusively the red-top tabloids - for their coverage of science stories. Ranging from the baseless scaremongering around MMR to the PR fluff of wacky equations and bogus (careful...) 'trials' of dietary supplements, the media's inability to report on scientific material accurately or fairly is not news in itself - just take a look over at and you'll see dozens of press articles pwned for indulging in bias, statistical error or just plain idiocy.

To the roll-call of infamy in science journalism we may add stories from earlier in the week (in The Sun and The Mirror amongst others) regarding four-year-old girl Izabelle Evans, some stem cells, and China.

LITTLE Izabelle Evans who was born blind has seen her mum and dad for the first time at the age of FOUR — thanks to a miracle procedure carried out on the other side of the world.
Brave Izabelle can now see up to three feet and recognise her parents' faces following groundbreaking stem cell treatment 
(emphasis original).

Curious, I read on in hope of finding out what cell type was used in the treatment, what the mode of delivery and dosage were, how efficacy was determined - alas, no luck.

Helpfully, The Mirror went into more detail, describing how septo-optic dysplasia caused Izzy's visual impairment:
[Izzy] only has a few hundred optic nerves (sic) sending information to her brain. A person needs millions to be able to see. Her family heard about the stem cell treatment which involves injecting the spinal canal with cells taken from umbilical cords of healthy babies. The cells are then used to rebuild optic nerves.
Leaving aside the technicalities - we only have one optic nerve per eye, made up of the axons of millions of neurones - several questions arise. Was the injection of umbilical stem cells carried out under a clinical trial protocol or offered as a commercial service? What precautions were taken to ensure that Izabelle's immune system did not react adversely to receiving cells from another person - or were Izzy's own cells, perhaps frozen down at birth, used? How was the patient's vision tested before and after treatment?

Of course, had we been reading about Izabelle's case in a peer-reviewed article in a scientific journal, we may well have had the answers. As it is we're left with the tantalising story of a little girl (cue pictures of her with family in front of seasonal decor) and her anecdote of 'improved vision' following 'stem cell therapy.'

Having seen at close quarters how a genuine clinical trial is carried out - with rigorous pre-clinical testing of the treatment lasting years, massive regulatory hurdles to be overcome (rightly) and the thorough post-treatment reporting that is required to qualify for publication in a high-flying journal - I feel the need to express my disappointment. Not only does The Sun put in jeopardy it's otherwise decent record on reporting health issues (not least the waste of money that is NHS-funded homeopathy), stories like Izzy's unjustifiably raise people's expectations of what medical science can deliver.

Another aspect of both the Sun and Mirror's reporting concerned me - the focus on the non-availability of such treatment - whatever it constituted - in the UK, and the fundraising that allowed the Evans family to head to China where she was treated. There may well be good reasons why direct injections of stem cells into the spinal canal are not carried out in the UK - it may be for lack of the very safety and efficacy data missing from Izzy's story. What we don't need is for families of patients with rare disorders - despite being understandably desperate for anything that might help - to jet off to jurisdictions with lax controls over clinical protocols and less regard for patient safety - which may well be the case here.

By reporting an isolated anecdote such as this, without corroborating evidence on safety or efficacy, journalists do science and medicine a huge disservice. There's nothing wrong with reporting genuinely exciting advances in medical science in the lay press - in fact it's a vital part of making scientific progress for the population at large to understand the likes of gene and cell therapy - it's just that this kind of reporting distracts from the real deal - and makes it that much harder for properly conducted trials and their outcomes to get the recognition they deserve.


Stephen Moss said...

Good objective analysis of some questionable clinical practice. I have searched Pubmed for any hint of published clinical trial data relating to the centre offering this stem cell treatment, and not surprisingly can find none. This is not to say that the therapy may not work, but it does mean that parents such as those in this story are taking unknown risks. And one can only imagine the difficulty/impossibility of any redress in the event of an adverse outcome.

David Colquhoun said...

Excellent. And I like the title. There is a tendency for "Materials and Methods" to be described inadequately in real journals, never mind tabloid newspapers. That is not a good thing.

teekblog said...

@Stephen Moss: thanks. What I find disturbing is the apparent lack of academic rigour - not because I am a snob (although I am...), but because it puts patients in danger. Although PubMed draws a blank, Google leads one to a site that has to be seen to be believed: China Stem Cell News, with myriad patient testimonies but nary a mention of genuine clinical evidence... I feel a follow-up post coming on this weekend :-)

teekblog said...

@David Colquhoun - thanks for the comment. When Methods are lacking in an academic journal, it can be frustrating if one wants to understand others' work - in this case, the lack of detail may indicate that a patients life has been placed at risk.


SUIRAUQA said...

I saw a similar story on NPR about a child with optic nerve hypoplasia. What I found the most chilling is the fact that the Chinese doctor in charge, one Dr. Sean Hu, apparently admits that he doesn't know the mechanism behind the putative benefit AND isn't worried by the ethical implications of his continuing work.

Stem cell therapy has much promise, along with many risks. How can someone in good conscience apply to children this virtually untested, unproven therapy when nothing is known about its effects and unintended consequences? Apparently, this has even the Chinese scientists worried, according to the NPR report.