Posts Tagged Guardian

No drug is tested on humans, except all the drugs tested on humans

Another day, another “science” piece on Comment is Free that plays fast and loose with the science. Let’s get this over with.

When a dog with a life-threatening uterine infection was recently carried into my veterinary practice, I was confident we could save her. Following a rapid infusion of intravenous fluids and antibiotics, I performed emergency surgery. Partly because of the drugs she was given, “Annie” recovered well. I had the luxury of knowing they had all been tested on other animals of the same species, and were unlikely to inadvertently cause any harm.

Unfortunately, my brother does not have that luxury. He works as a resident in a hospital emergency department, and although the drugs he uses have also been thoroughly tested on animals, this doesn’t provide quite the same level of comfort. It is one of the tragedies of modern medicine that adverse reactions to pharmaceuticals cause thousands of potentially avoidable deaths.

Sadly, dogs are just as susceptible to drug side effects as humans are. But more importantly, “I had the luxury of knowing they had all been tested on other animals of the same species [...] my brother does not have that luxury“? That sounds to me like a fairly strong implication that drugs are never tested on humans. This is obviously, blindingly untrue. Any drug has to go through multiple stages of human testing, from safety tests in healthy volunteers, to short laboratory tests, to huge randomised trials involving thousands of patients – sometimes lasting decades. At every stage of the process, the patients are carefully observed, and (in theory*) any side effects are noted and analysed. Indeed, Andrew Knight admits this in the next two paragraphs:

Modern drugs are more carefully studied than ever before. After lengthy tests on animals, those considered safe, and potentially effective, enter very limited human trials. About 92% are then weeded out and deemed unsafe or ineffective.

The remaining 8% are some of the most closely scrutinised compounds on the planet. You might be forgiven, therefore, for assuming they are safe. But at least 39 studies over three decades have ranked adverse drug reactions as an important cause of hospital deaths. Only heart disease, cancer and stroke are more reliably lethal.

No drug is ever tested on humans, except for every single drug ever, all of which are tested on humans!

Adverse drug reactions are always something drugs companies should try to reduce, but for the vast majority, it’s not the case that they weren’t picked up in testing – cases like thalidomide, where no-one knew the risk until pregnant women started using it, are the exception, not the norm. Most adverse side effects that are known about and carefully measured, and the doctor will have had to measure up the risks versus the benefits for each before prescribing the drugs – if you look at the study he links to, 75% of severe reactions to drugs are known side effects caused by dose, and a lot of the rest are allergic reactions. As the paper itself says “This may suggest that many [adverse drug reactions] are due to the use of drugs with unavoidably high toxicity.” We could test as hard as possible, but there would always be drugs that could never be 100% safe.

The author of the piece, Andrew Knight, has written a book on the subject, linked to in the piece (it also apparently focuses more on data than debate, which is usually good, though admittedly the only scholarly review I could find accused the book of bias in the way it analysed this data – Knight’s rebuttal is here), and he does seem to be someone knowledgeable in the field. But that doesn’t change the fact that this particular column is bad. It defends a reasonable viewpoint – let’s try to find ways to test drugs on computers or in petri dishes rather than having to use live animals – with nonsense. Even if we did everything this column recommends, and managed to completely replace animal testing with simulations, I don’t see how it’d cause a significant change in the number of reactions to drugs. It might plenty of other good effects – not least, reducing the number of animals used, of course – but that wouldn’t be one of them.

* Sadly, some pharmaceutical companies have tried to hide the safety data for their drugs – just last week, GlaxoSmithKline was fined $3 billion for doing so – but as things stand, this would happen regardless of whether the safety data was from animals, humans or computers.

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Did GM soy cause allergies to soar? Probably not.

So, California’s planning a referendum on the labelling of genetically modified food. The Guardian has covered this not in it’s regular news pages, but in its Comment is Free section, under the title “How California’s GM food referendum may change what America eats“.

The article is mostly an opinion piece – fair enough – but there’s one statistic buried in there that leapt out at me.

While researchers have not yet found a “smoking gun”, which would prove that GM foods as a class are dangerous, there are troubling signs that they may be a factor in the recent epidemic of food allergies. Soon after GM soy was introduced to the UK, for example, soy allergies escalated by 50%.

The link there doesn’t go to a scientific paper, but to a piece on “News. Controversy. Opinion.” site Opposing Views, and their figures seem to come, ultimately, from American Academy of Environmental Medicine, a group that has some decidedly quackish views on topics like water fluoridation, vaccines and “Multiple Chemical Sensitivity” (a scientifically unfounded belief that everything in modern society contains toxins). It’s not impossible to support some outlandish ideas while being right about things, of course, but it does ring some alarm bells.

Neither article links to any of the studies it referenced, but with a bit of digging, I found this piece at Academics Review which seems to be dealing with the same statistic. Go there if you want the full takedown, but in a nutshell, it refers to marketing information from a group called “York Nutritional Laboratories” (which sell food allergy testing kits) the rise was in people with a particular antibody, not those who reported allergies and the study didn’t find any connection (the rise simply happened at a similar time to the introduction of GM, although it actually took place before GM soy became mainstream).*

I decided to have a look on Google Scholar for papers looking in the allergenicity of GM soy. There are plenty of studies and review papers looking into this – one, two, three, four, five – and all the ones I’ve found so far suggest that genetic soybeans and GM soybeans pose exactly the same risk of allergy (though as far as I can tell, these are all animal trials. There isn’t much data on human soy allergies out there).

In this case, the claim that GM soy may be responsible for a rise in allergies seems to be simply wrong.

* For the other major claim in Opposing View’s piece, about baby rats dying from eating GM soy, see this peer review of the paper, originally from Nature Biotechnology , which expresses grave concerns about the unusually high numbers of deaths in the control group – it looks like bad care killed the rats, not the soy)


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Mitochondria donation nonsense

A bunch of mitochondria just hanging out.

For various largely uninteresting reasons, I’ve not blogged lately. But then I came across this article on The Guardian website today, a for-and-against piece about mitochondria donation with an “against” argument from Peter Saunders that veers from irrelevant to flat out wrong. Let’s get started!

To begin with, this is not about finding a cure. It is about preventing people with mitrochondrial disease being born. These new technologies, even if they work, will do nothing for the thousands of people already suffering from these diseases, or for those who will be born with it in the future.

Now, here’s the first dodgy argument, one that I’m almost tempted to call a dog-whistle. Mitochondrial donations are not about “preventing people with mitrochondrial disease being born“, they’re about “preventing people being born with mitrochondrial disease”. Just look at how moving that phrase “being born” a few words to the right changed a factual statement about the procedure into a non-sequitur about abortion.

It’s of course true that unfortunately, this procedure will do nothing to help people that already have mitochondrial diseases – removing a mutation from the body is perhaps the most impossible thing in all of medicine – but that’s no argument against the procedure.

Also, Saunders claims that there is no need for the procedure when egg donation is already possible. Bear this in mind; it’ll come up again later.

Will it work? This technology uses similar “nuclear transfer” techniques to those used in “therapeutic cloning” for embryonic stem cells – which has thus far failed to deliver, and animal-human cytoplasmic hybrids (“cybrids”). [...] Yet cybrids are now a farcical footnote in history. They have not worked. Ironically, it was in that same act of parliament that provision for this new research was also made.

First of all, cybrids were legalised in 2008. 3-4 years is not that long a time in medical research, especially for research into slow-developing, long-term conditions like Alzheimers and Parkinsons. But I decided to have a look on Google Scholar, to see if cybrids were just a “farcical footnote”. Since 2008, there have been at least 362 papers about cytoplasmic hybrids, including 114 in the last year and a half or so. Some of these are papers exploring the ethics of the procedure, but an awful lot are detailing actual breakthroughs made using these cytoplasmic hybrids.

Embryonic stem cell research, being far more mature, is even more successful, with stem cells relieving paralysis in rats and the first clinical trials in humans showing promising results. Hardly a field that has “thus far failed to deliver”.

But even if he was telling the truth, and both fields had proved to be dead ends, this would still be irrelevant to mitochondrial donation. All it says is that mitochondrial donation uses one technique which is also used in stem cell research. As far as arguments go, this is up there with “vegetarians are evil because Hitler was a vegetarian”.

Is it safe? No. Each technique involves experimental reproductive cloning techniques and germline genetic engineering (that is, it affects the genes passed on to children) – both of which are highly controversial and potentially dangerous. Cloning by nuclear transfer has so far proved ineffective in humans and unsafe in other mammals with a large number of cloned individuals spontaneously aborting, and others suffering from physical abnormalities or limited lifespans.

Well, it’s good thing there’s no cloning involved with this technique, thus making that last sentence completely pointless scaremongering.

Also, as the Guardian noted last week, any changes, or unpredicted genetic problems (mutations) will be passed to future generations.

This is true, but the thing is: if a woman with a mitochondrial condition doesn’t use this technique and conceives a child naturally, there is a 100% guarantee that the mitochondrial defect will be passed to the future generation(s). The whole point of this method is to reduce the number of dangerous mutations being passed on.

Is it ethical? No. A large number of eggs will be needed, involving risky and invasive “harvesting” for women donors. How many debt-laden students or infertile women will be exploited by the offer of money, or free IVF treatment, in return for their eggs? How many embryos will be destroyed?

Ok, so, remember how earlier egg donation was a totally ethical alternative to mitochondrial donation? Well, with a deft sleight of hand Saunders is now claiming that egg donation is unethical!

There are concerns about paying people to donate body parts/fluids – it’s one of the most hotly discussed areas of bioethics – but in the UK, donors are not paid to donate eggs. They can have their travel and accommodation expenses paid (up to £750), but that’s it. There’s simply no room for the kind of exploitation Saunders worries about.

As far as I can tell, there is no difference to the egg donor between standard donation and mitochondria donation. The technique doesn’t necessarily require any extra eggs – though I suppose that depends on its success rate, which, since the technique is still experimental, no-one yet knows – and it doesn’t require any more embryo destruction that IVF or standard egg donation.

Then there are the issues of identity confusion for the children, who in effect will have three biological parents. Some mitochondrial diseases are much less serious than others. Once we have judged some affected babies not worthy of being conceived, where do we draw the line?

The mitochondria are, as the standard explanation goes, the little power stations that fuel each cell, and mitochondrial DNA has no effect on the wider body outside these power stations. A baby conceived by mitochondria donation is closer to having two parents than than a baby conceived by standard egg donation (since in mitochondria donation, all the DNA that affects what the baby actually looks like comes from the mother, not the donor), and if “identity confusion” is a concern, it’s odd that he’d endorse adoption either. And this technique does not mean any baby is “not worthy of being conceived” (unless he’s referring to the parents’ choice not to conceive naturally in the first place, in which case his argument is grosser and more unethical than I thought) – conception will still happen, it’s just that egg will be slightly modified first.

This debate is not being handled responsibly. The research scientists involved have financial and research-based vested interests, and getting the regulatory changes and research grants to continue and extend their work is dependent on them being able to sell their case to funders, the public and decision-makers.

I don’t think “I’m a research scientist and I want to continue my research” counts as a vested interest. It’s not like researchers are pretending their research isn’t dependent on this technique being allowed. I genuinely wonder how Saunders would prefer this debate be handled – he certainly never explains. Speaking of not handling debates responsibly, though neither Saunders nor The Guardian point this out, Saunders is the CEO of the Christian Medical Fellowship, a group that speaks out against a variety of medical techniques on religious grounds. As Mark Henderson said on Twitter, “Saunders makes many bad arguments vs mitochondrial transplants, omitting real reason he opposes: religion [...] Nothing wrong with opposing embryo research for religious reasons, but those who do should admit it, and that no evidence would convince them

Let’s concentrate on finding treatments and providing better support for affected individuals, rather than spending limited health resources on unethical, risky and highly uncertain hi-tech solutions that will most likely never deliver.

We already know that, no matter how difficult mitochondrial donation is, finding a cure for mitochondrial disorders is far far harder still – and perhaps impossible with our current knowledge of genetics. A human body contains billions of cells, each one containing at least one and often tens or hundreds of mitochondria. Replacing or fixing all of them would be far more difficult than replacing the mitochondria in a single cell; if you want an efficient way of spending limited health resources (really, limited research resources – the funding for this research would not be directly linked to the NHS), donation research is surely a better route to take.

(I intended to, for balance reasons, point out any inaccuracies in the response from the Nuffield bioethicist arguing for the procedure, but it already seems pretty sensible and fair. Quelle surprise…)

Edit: Also thanks to Mark Henderson for pointing out that the research is being carried out at Newcastle University and entirely publicly funded by the Wellcome Trust and the Medical Research Council – there are no vested business interests involved either.



Happy birthday Neptune?


Happy birthday!

Just a quick post: according to The Observer, tomorrow (July 11) will be one Neptunian year since the discovery of the planet Neptune. Except…

One year on Neptune is 60,190 Earth days. Neptune was discovered on 23 September 1846, so Neptune’s first birthday will be 60,190 days after this date.

23 September 1846 + 60,190 days = July 10, 2011

Neptune’s birthday is today, not tomorrow! We’ll all be celebrating on the wrong day!

Never mind phone hacking, this is the real scandal.

Edit: The BBC is even more wrong, claiming Neptune’s birthday is July 12. The philistines!

Double edit: In fact, it looks like we’re all right! July 10 is one average Neptunian year after the date of discovery, July 11 is the day when Neptune will have made precisely one orbit around the solar system’s barycentre (i.e., its centre of mass when you take the Sun and all the planets into account), and July 12 is the day that Neptune will have made precisely one orbit around the Sun. (A figure of July 13 is floating around as well, most likely as a result of an Indian newspaper article which has taken timezones into account). Thanks to Up, Blogstronomy and the Wikipedia users on Talk:Neptune!

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Nuclear cover up? Probably not

The Guardian‘s website is at the moment leading with yet another story about leaked emails: Revealed: British government’s plan to play down Fukushima.

What dastardly scheme was the government up to?

British government officials approached nuclear companies to draw up a co-ordinated public relations strategy to play down the Fukushima nuclear accident just two days after the earthquake and tsunami in Japan and before the extent of the radiation leak was known.

Internal emails seen by the Guardian show how the business and energy departments worked closely behind the scenes with the multinational companies EDF Energy, Areva and Westinghouse to try to ensure the accident did not derail their plans for a new generation of nuclear stations in the UK.

I’m not sure “play down” is really the right phrase to use here. After all, this appears to be the relevant part of the worst email:

We need to quash any stories trying to compare this to Chernobyl – by using the facts to discredit.

Is that “playing down” Fukushima, or putting it in perspective? This email was sent long before the worst of the damage was known, at which point Chernobyl comparisons would have been gross exaggerations.

Yet over and over again, the Guardian seems to forget that this was written when there was little information available, and the reactors still appeared to be intact:

The business department emailed the nuclear firms and their representative body, the Nuclear Industry Association (NIA), on 13 March, two days after the disaster knocked out nuclear plants and their backup safety systems at Fukushima. The department argued it was not as bad as the “dramatic” TV pictures made it look, even though the consequences of the accident were still unfolding and two major explosions at reactors on the site were yet to happen.

Well yes, there were serious explosions that resulted in radiation release, but they hadn’t happened when the email was sent. What was the civil servant* supposed to write?

The nuclear industry, like any industry that tries to balance profit against public good (see: transport, healthcare, media, communications), is often pretty hard to defend, but to be honest, it doesn’t come across too badly in the emails.

Sometimes they seem a bit dickishly entitled – Westinghouse probably didn’t win any points for emailing the government to object to Nick Clegg’s choice of wording in a speech – but most of the time, no matter how The Guardian spins it, it’s hard to see PR collusion in EDF offering to be “sensitive” to events in Japan in decommissioning old plants, the government explaining its new build policy, or Westinghouse discussing changes in reactor design to improve earthquake safety. I certainly can’t see what’s wrong with organising a conference to discuss how to “maintain confidence among the British public on the safety of nuclear power stations” with “factual and scientific evidence”.

In fact, given that nuclear new build is a government policy being carried out by private companies, it’s hard to see how the government could have made any statements about British nuclear power without talking to the nuclear industry.

A few emails discuss the PR response, but apart from the one from the unnamed civil servant, who fair enough does seem a bit too gung-ho about nuclear power, they make it clear that the government’s position is distinct from the industry’s, and refuse to join the industry in making a joint response (for instance, check out the email “Re: Nuclear Lines – Messaging” on page 15, sent March 14, 10:31, and any other email in that converstaion).

If a reservoir had collapsed, and the government emailed water companies for comment and to discuss preventing public panic, would that be news? Probably not.

If a train had crashed, and the government invited representatives of train operators to discuss the impact on the future of the railways, would that be news? Probably not.

So when the government discusses the future of the nuclear industry with the nuclear industry following a nuclear disaster, why is that news?

* Incidentally, the civil servant’s name has been redacted, but according to the BIS, it’s someone pretty minor, not a minister or someone with power over policy. So that’s not really a “government plan” then, is it?

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Mobile phones and cancer. Again

(H/T @DickMandrake)

This will be all over the papers today, so here’s a quick run down of what’s actually happened.

Last year the World Health Organisation released its Interphone report (PDF) into the link between brain cancer and mobile phones. For the most part, they found “no increase in risk of glioma or meningioma [types of brain cancer] was observed with use of mobile phones”. However, for very heavy users (the top 10% of the population), there was a statistically significant increase in the odds of developing a form of brain cancer known as glioma but “but biases and error prevent a causal interpretation” – there is too much uncertainty in the data to know whether heavy mobile phone use caused cancer or whether something else was to blame. On the one hand, they found there appeared to be a connection between which side of the brain the tumour developed in and which hand users held the phone in – a sign that phones might cause cancer – but on the other hand, while extreme users experienced a big increase in brain tumours, people who used their phones even slightly less saw no change in brain cancer – a sign that mobile phones might not cause cancer.

Fast forward a year, and the WHO’s International Agency for Research on Cancer (IARC) has issued a press release (PDF) about an upcoming report which, based on the Interphone study and some other papers, will classify the electromagnetic (EM) fields from mobile phones as “possibly carcinogenic to humans” meaning there is “limited evidence” that they may cause cancer. In other words, it’s the exact same conclusion as the Interphone report, but this time the report is focusing on the negative – heavy doses may cause cancer – rather than the positive – light doses probably don’t cause cancer.

That in itself is very reasonable – even if mobile phones carry a very slight cancer risk, the IARC still need to know what that risk is. The problem comes when the media, reporting this in the usual shades of black and white, ignore all this nuance in favour of scares:

The Mail screams “Mobile phones CAN increase risk of cancer: Doctors reveal shock results of major study into effect on the brain“, magically turning “possibly causes cancer” into “CAN cause cancer”. It’s not really a shock result either, since it came out a year ago. The Mail also brings up the recent Council of Europe draft report that suggested banning mobiles from around schools, ignoring the fact it was pseudoscientific rubbish based on research from quacks.

The Express goes for the similar “Shock cancer warning over mobile phone use“, claiming “MOBILE phones have been officially linked to cancer for the very first time by a team of world experts”. Again, the report is a year old, it’s not a shock! They also manage to get in some ridiculous guilt-by-association:

But they classified mobile phones in the same danger category as the pesticide DDT and petrol engine exhaust, meaning they are possibly carcinogenic to humans.

Petrol exhaust and DDT are pretty dangerous, but that’s not necessarily because they cause cancer! Nor does being in the same group as these mean it carries the same risk of cancer, either. It just means that we have the same level of evidence for a cancer risk, which isn’t the same thing. For example, DDT is now banned worldwide, with most developed countries banning it in the 70s. This means that people aren’t being exposed to it any more (a good thing, of course!), so we can’t study its effects and work out exactly how dangerous it is.

The Guardian meanwhile goes for a tenuous connection to the risks of mobile phone base stations and wi-fi, even though the exposure to EM from these is much lower than from holding a phone to your ear – and we know even then it’s only the heaviest exposures that may cause cancer.

The Telegraph also makes the ridiculous DDT comparison, but at least they quote the great Ed Yong, head of health information at Cancer Research UK, who sensibly sums up the evidence:

“The risk of brain cancer is similar in people who use mobile phones compared to those who don’t, and rates of this cancer have not gone up in recent years despite a dramatic rise in phone use during the 1980s.

“However, not enough is known to totally rule out a risk, and there has been very little research on the long-term effects of using phones.”

(They also quote a professor of Medical Physics and Director of the Mobile Operators Association, but to be honest, they seem to have gone into damage control mode before there’s been any damage to control. Pro-tip, guys – if you ever end a paragraph about the health risks of something by saying “The social and technological benefits also need to be emphasised“, then you sound like a cyberpunk bad guy, even if you truly mean it.)

Anyway, for a little perspective, there’s a great interview with Ed Yong about the news here. Read it!

Edit: There are also great pieces out there on this from Pharyngula, Respectful Insolence, Cancer Research UK, Tom Chivers, Only That In You, Scientific American and Bad Astronomer. Good old blogosphere!

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Is dodgy neuroscience in journalists’ nature or their nurture?

(Hat-tip to This Wicked Day for the link, and for pointing out that I can’t spell)

Another story exclusive to all papers: The Guardian, The Telegraph, The Independent, The Daily Mail, The Mirror and The Daily Express have all churned out a story based on this morning’s Today (two parts, sound only).* The show was guest edited by Colin Firth, who decided to use this as an opportunity to commission some research into whether political views are visible in brain structure.

The results are fairly interesting – though the only place they’ve so far been published is on the Today show’s blog, which means I can’t really comment on them in any detail. As far as I can tell, this is what they found: people who self-identified as left-wing or liberal were found to generally have a thicker anterior cingulate – the part of the brain believed to deal with empathy and decision making – while people who described themselves as right-wing conservative had a larger right-hand amygdala – the structure which seems to be do with anxiety and higher emotion processing. There seems to be some confusion on the Today show blog about whether it’s a “strong correlation” or “a weak but statistically significant correlation”.

The problem is that, just as with the so-called “liberal gene“, there’s nothing here which proves that these structures actually cause people to be left or right wing. For one thing, we don’t know which way the correlation runs; in other words, whether having a larger amygdala causes people to be right wing, or whether being right wing just makes the amygdala grow – or whether there’s something else hidden in the body which affects political views and brain structure.

Secondly, again, just like with the liberal gene, it’s possible that political views are only indirectly linked to brain structure – the fact that the correlation between the two was weak would seem to back this up. For example, if people with a thick anterior cingulate are generally better at empathy, and more empathic people are generally more liberal, then there might be a small correlation between cingulate size and left wing leanings. This would not mean that one causes the other however! It would be perfectly possible for someone with a thin cingulate to be empathic, and for someone with a thick cingulate to be self-centred. Our brain structure isn’t the only thing that affects our personality – nor are our political views driven entirely by our empathy and our anxiety.

* Interestingly, the reliably right wing Mail goes for the self-deprecating headline “Tory voters found to have larger ‘primitive’ lobe in brain” while the similarly leaning Express runs with the exact opposite: “Lefty? Blame the shape of your brain“.

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