Is it fair to compare "Alternative Facts" with "Alternative Medicine"

I came across this “meme” on Facebook today:

“The very concept of alternative medicine exists to create a double standard where the rules of science and evidence are stood on their head specifically to manufacture the result that is desired by cranks, charlatans, snake-oil salesmen, and self-proclaimed gurus. There is no alternative medicine. There is just medicine. Either it works or it doesn’t work.”
-Steven Novella

The inevitable retort was: but what about some “natural/traditional” medicines that have not been thoroughly studied. These might work. So, surely it’s an unfair comparison?

My response to that is this:

When people bullshit based on their gut feelings, they can also be right sometimes. It’s only when someone looks into it do we know whether it is actually fact or fiction. “Folk medicine” and natural products may have good (or bad!) effects but it is wrong to imply that they are medicine until we know whether/when they work.

In the same way that an opinion is not an “alternative fact”, a natural product that somebody thinks might do something is not “alternative medicine”.

Then, of course, there is the less generous - but even more apt - comparison of bare-faced lies with bare-faced fraudulent treatments like homeopathy - things demonstrably false that are being badged at truth under the label “alternative”.

I just hope that the war on “Alternative Facts” is more successful than the war on “Alternative Medicine”. The real problem with taking action based on made up stuff is that reality doesn’t care how well-meaning you are, or how much you want it to be true. Hopefully, America will not suffer too much at the hands of reality before Trump and/or his cronies realise this.

Are data scientists just "research parasites"?

Although it passed me by at the time, the New England Journal of Medicine - a highly respected top-tier medical journal - featured an editorial on data sharing¹ in January. It was so bad, that the International Society for Computational Biology (ISCB) felt the need to respond in the most recent issue of PLoS Computational Biology². I’m glad they did, for the editorial was awful.

It starts quite well:

The aerial view of the concept of data sharing is beautiful. What could be better than having high-quality information carefully reexamined for the possibility that new nuggets of useful data are lying there, previously unseen? The potential for leveraging existing results for even more benefit pays appropriate increased tribute to the patients who put themselves at risk to generate the data. The moral imperative to honor their collective sacrifice is the trump card that takes this trick.

But then rapidly goes downhill:

However, many of us who have actually conducted clinical research, managed clinical studies and data collection and analysis, and curated data sets have concerns about the details. The first concern is that someone not involved in the generation and collection of the data may not understand the choices made in defining the parameters. Special problems arise if data are to be combined from independent studies and considered comparable. How heterogeneous were the study populations? Were the eligibility criteria the same? Can it be assumed that the differences in study populations, data collection and analysis, and treatments, both protocol-specified and unspecified, can be ignored?

Many of us who have actually conducted data analysis would retort: if you have concerns about the details then you should be making those details clear. If choices are important, explain them! For sure, you cannot just blindly combine multiple datasets that have different biases etc. but what decent scientist would do that (without an explicit caveat regarding that assumption)?

Longo and Drazen seem to be implying that all data scientists are bad scientists. As I’ve said before, Bioinformatics is just like bench science and should be treated as such. If you are making dodgy assumptions about data, you are doing it wrong. (Though people do make mistakes - the data collectors too.)

It gets worse:

A second concern held by some is that a new class of research person will emerge — people who had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited. There is concern among some front-line researchers that the system will be taken over by what some researchers have characterized as “research parasites.”

Apparently, some people might think I am a “research parasite” because I sometimes analyse other people’s (published) data without talking to them about it. I’m glad the ISCB called them out on this. Newsflash: science only makes progress by people trying to disprove what other researchers (and, ideally, themselves) have posited. Science is a shared endeavour. If someone uses your data to do something (good), good! If you don’t want that, embargo the data or delay publication. Then question your motives; if glory is what you seek, perhaps you’re in the wrong profession?

A researcher frightened of “stolen productivity” is perhaps a researcher struggling for ideas. (I’d love someone else to answer some of the questions I have kicking around so that I could move on to the next thing!) A researcher scared of someone trying “to disprove what the original investigators had posited” has bigger problems.

The rest of the editorial is not so bad, as it tells the tale of a fruitful collaboration between “new investigators” and “the investigators holding the data”. Of course, this is the ideal scenario, short of generating the data themselves. The fact that the authors felt the need to stress this - and the language used of “symbiosis” versus “parasitism” - demonstrates that Longo and Drazen are utterly clueless about the modus operandi of the disciplines they discredit. Whilst ideal, direct collaboration is not always feasible. Sometimes - when the original investigators are too attached to their pet hypothesis or conclusion - it is not desirable.

They end:

How would data sharing work best? We think it should happen symbiotically, not parasitically. Start with a novel idea, one that is not an obvious extension of the reported work. Second, identify potential collaborators whose collected data may be useful in assessing the hypothesis and propose a collaboration. Third, work together to test the new hypothesis. Fourth, report the new findings with relevant co-authorship to acknowledge both the group that proposed the new idea and the investigative group that accrued the data that allowed it to be tested. What is learned may be beautiful even when seen from close up.

This sounds OK - and the described model may even be data sharing at its best - but the implication that anything short of this ideal is somehow inadequate is naive and unhelpful.

First, one person’s novel idea is another person’s obvious extension. And anyway, why should having one idea give you automatic rights to all obvious extensions?! Why should the rest of us trust the data gatherers to do a good job - especially if they exhibit attitudes towards data akin to these authors?

Second, identifying a potential collaborator does not guarantee collaboration. Ironically, the kind of paranoid narcissist that would use a term like “research parasite” is unlikely to be open to collaboration.

Thirdly, citation is a form of co-authorship that acknowledges “the investigative group that accrued the data”. Wanting full co-authorship where additional intellectual input is not required is just greedy. (And a note to the narcissist: self-citations are generally seen as lower impact than citations by wholly independent groups.)

Longo and Drazen should stick to commenting on what they know, whatever that is, and leave data scientists to worry about how they conduct themselves. With this editorial, they have done everyone - not least of which themselves - a deep disservice.

---

1. Longo D.L., Drazen J.M. Data Sharing. N Engl J Med, 2016. 374(3): p. 276–7. doi:10.1056/NEJMe1516564.

2. Berger B, Gaasterland T, Lengauer T, Orengo C, Gaeta B, Markel S, et al. (2016) ISCB’s Initial Reaction to The New England Journal of Medicine Editorial on Data Sharing. PLoS Comput Biol 12(3): e1004816. doi:10.1371/journal.pcbi.1004816.

Avoiding measles vaccination does not just put children at risk of measles

If you know anyone who is still undecided about, or opposed to, vaccination, please point them to the latest evidence in the journal Science: Measles vaccine protects against other deadly diseases.

The first paragraph sums it up nicely:

“Measles kills about 140,000 people worldwide every year, but the millions of kids who have survived the disease aren’t in the clear. A new epidemiological study suggests that they remain susceptible to other infections for more than 2 years, much longer than researchers anticipated. The results bolster a hypothesis that the measles virus undermines the immune system’s memory—and indicate that the measles vaccine protects against other deadly diseases as well.”

Basically, it seems that the measles virus kills of large number of immune memory cells - the ones that give you a faster, stronger immune response to repeated infections. This means that even if measles itself does not kill you, there is a good chance that it will have “reset” your immune system to something approaching a newborn, removing a whole suite of previously acquired immunity.

This helps to explain why child mortality rates drop much more than would be expected following the introduction of measles vaccination (e.g. this study): not only are deaths from measles and direct measles-associated infections reduced, deaths from other infections are reduced too.

Even if you don’t care about herd immunity and your obligation to the rest of society, get your children vaccinated.

Yet another study debunks yet another vaccine/autism myth

As reported by ABC Science last week, a large study (roughly 95,000 people) has hammered another nail into the well-and-truly debunked vaccine-autism link.

In an accompanying editorial in [the Journal of the American Medical Association (JAMA)], Dr Bryan King, a doctor at the University of Washington and Seattle Children’s Hospital, says the data is clear.

“The only conclusion that can be drawn from the study is that there is no signal to suggest a relationship between MMR and the development of autism in children with or without a sibling who has autism,” writes King.

“Taken together, some dozen studies have now shown that the age of onset of ASD does not differ between vaccinated and unvaccinated children, the severity or course of ASD does not differ between vaccinated and unvaccinated children, and now the risk of ASD recurrence in families does not differ between vaccinated and unvaccinated children.”

Make no mistake: if you avoid vaccines in fear of autism, you are a misguided fool. If you spread this myth, you are an ignorant menace to society. This may sound harsh but people can really die if anti-vaxxers get their way.

Reference:

Jain A, Marshall J, Buikem A, Bancroft T, Kelly JP & Newschaffer CJ (2015): Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism. JAMA 313(15): 1534-1540.

Good news! WHO calls for results from all trials to be reported

A bit belated but good news worth sharing nonetheless. From Ian Bushfield at Sense About Science, and as reported in Science and other media sites:

For the first time ever, the World Health Organisation (WHO) has taken a position on clinical trial results reporting, and it’s a very strong position! The WHO now says that researchers have a clear ethical duty to publicly report the results of all clinical trials. Significantly, the WHO has stressed the need to make results from previously hidden trials available. Ben Goldacre said, “This is a very positive, clear statement from WHO, and it is very welcome.” Ilaria Passarani from the European Consumer Organisation BEUC called it “a landmark move for consumers.” It is the position we and hundreds of you wrote to the WHO last autumn urging them to adopt. Well done everyone!

You can read more about the WHO’s statement and responses to it on the AllTrials website.

Further reading: Goldacre B (2005): How to Get All Trials Reported: Audit, Better Data, and Individual Accountability. PLoS Medicine 12(4): e1001821.

Antibiotics really matter and need more research funding

Last year, I went down with tonsillitis on New Year’s Eve. The timing sucked a bit but I guess there are no good times for such things to happen. However, I was/am lucky: lucky because I live in an age where antibiotics are available and still work.

As a scientist, I often get frustrated about science funding. Firstly, there’s not enough of it (compared to other endeavours of less benefit to both society and the economy) but secondly, a lot of it goes to the wrong places, namely human diseases such as cancer. Don’t get me wrong: I’d love to see cancer cured. It’s just that there are bigger fish to fry, and global crises looming that would make diseases of old age such as cancer and Alzheimer’s a bit of a moot point.

An obvious need of greater funding is climate change, thrown into the spotlight again (as if it were needed) by the confirmation that 2014 was the the warmest year on record. Another is the development of new antibiotics.

Antibiotic resistance is a big problem and one that is currently only getting worse. We are heading for a “post antibiotic world”, which is a really scary thought. Indeed, some scientists have argued that antibiotic resistance is a bigger problem than climate change because we have the technology to combat climate change, we just lack the political will. We do not yet have the technical solution to the impending “antibiotic apocalypse”, hence the real need to throw money at research into solutions.

The annoying thing is that this is not a problem that has snuck up on us. In an editorial from 1997 entitled “Antibiotic Armageddon”, Calvin Kunin from The Ohio State University wrote:

“The advances of the antimicrobial era are being dissipated by the emergence and spread of resistant microorganisms, the inevitable consequence of intense use of antibiotics in humans over the past 50 years. The process is accelerating in the community as well as in hospitals and is a problem worldwide. The attrition of older drugs is sustained by the selective effects of new and more expensive drugs developed to overcome resistance. Novel compounds will no doubt be discovered, but their demise is inevitable. It is just a matter of time until resistant pyogenic organisms join the opportunistic microbes as major threats to humans.”

…

“[The] long-term outlook for control of antibiotic resistance is bleak. There are simply too many physicians prescribing antibiotics casually and too many people buying antibiotics without a prescription in developing countries. There is only a thin red line of infectious diseases practitioners who have dedicated themselves to rational therapy and control of hospital infections. The issues need to be presented forcefully to the medical community and the public. Third-party payers must get the message that these programs can save lives as well as money.”

Sadly, if these words were written today, I don’t think anyone would argue the point; not much has changed. And that’s without even mentioning the big problems caused by the long-running over-use of antibiotics is agriculture.

Things are not without hope. Earlier this month, a Nature paper by Lin et al. reported the discovery of a novel class of antibiotic from a screen of 10,000 bacterial strains, following the development of novel method to grow hitherto uncultured bacteria:

“Antibiotic resistance is spreading faster than the introduction of new compounds into clinical practice, causing a public health crisis. Most antibiotics were produced by screening soil microorganisms, but this limited resource of cultivable bacteria was overmined by the 1960s. Synthetic approaches to produce antibiotics have been unable to replace this platform. Uncultured bacteria make up approximately 99% of all species in external environments, and are an untapped source of new antibiotics. We developed several methods to grow uncultured organisms by cultivation in situ or by using specific growth factors. Here we report a new antibiotic that we term teixobactin, discovered in a screen of uncultured bacteria. Teixobactin inhibits cell wall synthesis by binding to a highly conserved motif of lipid II (precursor of peptidoglycan) and lipid III (precursor of cell wall teichoic acid). We did not obtain any mutants of Staphylococcus aureus or Mycobacterium tuberculosis resistant to teixobactin. The properties of this compound suggest a path towards developing antibiotics that are likely to avoid development of resistance.”

Personally, I remain skeptical about claims that teixobactin is resistance-proof. It may not be easy but I am sure the bugs will stumble across a way to evade or destroy the toxin and evolve resistance. Nonetheless, the message is clear: there are new antibiotics out there to be found. This one was found in the backyard of one of the researchers! Bacteria have been killing each other for millions, maybe billions, of years and so the global diversity in nature is likely to be massive. We just need the ingenuity and funding to find them.

References

Farrar J & Woolhouse M (2014). Policy: An intergovernmental panel on antimicrobial resistance. Nature 509:555–557

Kunin CM (1997). Antibiotic Armageddon. Clinical Infectious Diseases 25:240–1

Lin LL et al. (2015). A new antibiotic kills pathogens without detectable resistance. Nature doi:10.1038/nature14098

Celebrate 267 years of controlled trials with some affirmative action

Today is International Clinical Trials Day, apparently. Perhaps the most interesting thing about this is that the date commemorates the first recorded “controlled trial” (i.e. comparing treatment and control groups) by James Lind in 1747. 1747!

Anyway, it’s a good excuse to visit the AllTrials campaign site and watch their “make clinical trials count” video, if you've not heard of the campaign or still need convincing. Either way, sign up if you’ve not already! Without having all clinical trials published, vast sums of money are wasted and lives potentially put at risk.

Yet another lengthy investigation concludes that homeopathy is useless

Australia’s main body for health and medical research, the National Health and Medical Research Council (NHMRC), has recently conducted an extensive review of the “evidence for homoeopathy in treating 68 clinical conditions”. Predictably, it concludes “there is no reliable evidence that homoeopathy is effective for treating health conditions”.

No surprise there, but hopefully another nail prepared for the coffin of homeopathy, should drug stores develop of conscience and/or people ever stop getting taken in by utter crap.

The figures are scary, though. According to the news.com.au:

Australians spend almost $4 billion a year on complementary therapies like vitamins and herbs and almost $10 million on homeopathic remedies.

That's $10 million wasted. $10 million dollars that could have been spent on actual medicine. And I shudder to think how much of that $4 billion is wasted on complementary therapies with zero benefit, or worse - probably most of it. To put that figure in context, it is over five times the entire NHMRC 2013/14 budget of $771.2 million for health/medical research funding.

Perhaps the most revealing part of the article was the response of the homeopaths themselves:

However, Australian Homeopathic Association spokesman Greg Cope said he was disappointed at the narrow evidence relied on by the NHMRC in its report.

“What they have looked at is systematic trials for named conditions when that is not how homoeopathy works,” he said.

Homoeopathy worked on the principle of improving a person’s overall health and wellness, and research such as a seven-year study conducted in Switzerland was a better measure of its usefulness, he said.

I’m sorry… what‽ Homeopathy is based on the (utterly discredited) 200-year-old notion that “substances that produce symptoms in a healthy person can be used to [effectively] treat similar symptoms in a sick person”. This is not the principle of “improving a person’s overall health and wellness”, this a principle of targeting specific named symptoms with specific substances. Specific substances that are then diluted far beyond the point that any molecules (or “memory” thereof) remains in the solution (which is then often dropped onto a sugar pill), but specific substances that cause specific symptoms nonetheless.

Mr Cope is right about one thing, though: homeopathy does not work by treating named conditions. Homeopathy does not work.

Don't be an April fool - get (your kids) vaccinated

If there’s one thing that irks me as much as Homeopathy, it’s the anti-vaccination crowd. Therefore, I think that posts like the recent “Dear parents, you are being lied to” at Violent metaphors, deserve as much publicity as they can get. It's a well structured piece, heavily laden with links for further reading, with a heartfelt plea:

In only one respect is my message the same as the anti-vaccine activists: Educate yourself. But while they mean “Read all these websites that support our position”, I suggest you should learn what the scientific community says. Learn how the immune system works. Go read about the history of disease before vaccines, and talk to older people who grew up when polio, measles, and other diseases couldn’t be prevented. Go read about how vaccines are developed, and how they work…

As Professor Simon Foote wrote around a year ago, Parents have a moral obligation to children. Make no mistake about it, failing to vaccinate puts both your children and the children of others at risk. (And not just children.) As the Jenny McCarthy body count reports, preventable deaths in the US alone have exceeded 1300 since 2007, with 100 times that number of preventable illnesses. Whilst not the sole cause, anti-vaxxers must take a share of the responsibility for this.

Like Jennifer Raff at Violent metaphors, I’m sure that some of those opposing vaccination and/or advocating “parental choice” are doing so with the best of intentions. However, good intentions are no defence against disease and anti-vaxxers across the spectrum should take a long, hard look at themselves and ask whether their reasons for opposing the overwhelming global medical and scientific consensus are worth endangering even one life.

If you're not sure, I highly recommend reading the whole article. And if that’s too tame for your tastes, there is also the classic “Angry scientist finds an uneducated internet comment and delivers an epic response…”, which has a slightly less nuanced (but also informative) correction of some anti-vaxxer lies.

Support the Glasgow Skeptics in their fight against quackery

As some of my previous posts have indicated, I am not a great fan of Homeopathy. It is based on flawed principles that have been demonstrated to be wrong, it violates the Laws of Physics and it puts people at risk of harm and even death. It is quackery of the highest order and an embarrassment to a supposedly advanced post-Enlightenment society.

Sadly, however, we have a pro-Homeopathy MP on both the Commons Health Committee and Commons Science and Technology Committee. Furthermore, although not promoted on the NHS Choices website, this proven sham remedy is still available on the NHS despite having no evidence that it works other than as a placebo (what with them being nothing more than sugar pills).

One such NHS-funded travesty is the Glasgow Homeopathic Hospital. The Glasgow Skeptics are understandably saddened by this threat to Reason in their backyard and have set up a petition to NHS Greater Glasgow and Clyde to withdraw funding for Glasgow Homeopathic Hospital:

The Deputy Chairman of the junior doctors committee of the British Medical Association (BMA) has called homeopathy “witchcraft” and “nonsense on stilts”, whilst the BMA conference declared in 2010 that homeopathy has “no place in the modern health service”.

The NHS Choices website states that “there is no good-quality evidence that homeopathy is effective as a treatment for any health condition”, whilst the BMA's director of science and ethics, Dr Vivienne Nathanson, has said that “the funding of the homeopathic hospital should stop”.

It is therefore requested that NHS Greater Glasgow and Clyde withdraw funding for Glasgow Homeopathic Hospital.

You can sign the petition at change.org, here. They deserve the support of all right-minded individuals who want publicly-funded medicine to be evidence-based.

(Sadly, thanks to "Bad Pharma" not even medicine that appears to have evidence for efficacy is necessarily any good. If we cannot even dump the stuff that is proven to be crap, how can we hope to clean up the more complex mess of biased evidence?)

Are anti-vaxxers worse than Homeopaths?

Vaccination has hit the news again recently following an outbreak of Measles in Swansea. Sadly, indications are that this might be the direct result of successful lies and scaremongering by the fraudulent Mr Andrew Wakefield (not "Dr", since he got struck off “dishonest, unethical and callous” behaviour) at the end of the '90s, which caused a lot of parents to avoid giving the MMR jab to their kids. (And he's not finished.)

I don't generally go in for naming-and-shaming on this blog but if you are not familiar with Mr Wakefield's awful behaviour - and he still somehow seems to have supporters - I suggest you read this informative infographic by Darryl Cunningham, "The Facts In The Case Of Dr. Andrew Wakefield", or the more in depth expose by journalist Brian Deer. Not only did Wakefield fabricate data but he also had direct financial interests in seeing the MMR vaccine withdrawn. Bizarrely, far from being disowned by the anti-vax and alternative health community as a fraud and a miscreant, he has been embraced as a champion and hero of the cause.

Anti-vaxxers come in three main flavours, as far as I can tell. First, there are the snake-oil salesmen, who are actively trying to raise funds and/or sell alternative medicine through their scaremongering. These are the worst of the set because they pretend to be campaigning for truth when really they are putting people at risk by spreading lies to line their own pockets.

Second, there are the conspiracy theorists. These are deluded - often by the snake-oil salesman - into thinking that there is some giant conspiracy across science and healthcare professionals to lie to the public because we're all in the pocket of big pharma companies. (It is particularly ironic when these people support the likes of Andrew Wakefield, who was paid to discredit the MMR vaccine!) The tragedy here is that I suspect they are occasionally right about specific cases but, like the boy who cried wolf, who is going listen to them when blanket opposition to vaccination is so patently absurd? (I suspect this group also includes those who have been unfortunate enough to have a child suffer a rare condition or reaction and are looking for something more sinister than bad luck to blame.)

Lastly, there are those who are in favour of living a more "natural" lifestyle and who have sadly been suckered in by the more militant anti-vaxxers in online forums and the like. They may not fully buy into the whole "vaccines are evil" conspiracy, but they have been sufficiently brainwashed regarding the perceived dangers of tried-and-tested vaccines - and dulled to the very real dangers of not being vaccinated - that they avoid vaccinating their own children. This last camp includes the author of the recent "Comment is free" column in the Guardian, "Why I wish my daughter had been vaccinated". I hope more people read it. The evidence is clear. Vaccination is one of the most important medical innovations in history and has saved countless lives. As the article points out, people can only afford to be so complacent about it in the 21st Century because it has been so successful.

It is true that not all vaccines are 100% safe for 100% of people, and some of the stabilisers and adjuvants (immunity boosters) can have risks associated with them - which is why all new vaccines go through intensive testing, clinical trials and monitoring (as MMR has). These are not generally what the scaremongers are talking about, however, as they are generally not just opposed to new and unproven vaccines (indeed, they often promote their own unproven remedies) but instead trot out the same set of busted myths as a basis for opposing vaccination in general. These common myths are explained in "Six myths about vaccination – and why they’re wrong" from a great Australian site that I will be visiting again, The Conversation. (But you will still find them repeated.)

There is a small but genuine minority of people for whom vaccination is not possible, usually due to an allergy or immune deficiency of some kind. These people - along with the other small minority for whom vaccination fails - are wholly dependent on "herd immunity" to keep those nasty diseases at bay. This is the very real phenomenon where a sufficient proportion of the population is immune such that the disease is unable to take hold and spread.

By refusing to get their children vaccinated and discouraging others from doing so, anti-vaxxers are weakening the effects of "herd immunity" and out-breaks such as the current (and frankly embarrassing) UK measles outbreak in Wales are the result. You are not just endangering your own children, you put the children of others at risk, and that is just not fair. It's a bit like people who think that speed limits or the Highway Code do not apply to them. You can get away with such behaviour for a while so long as everyone else is following the rules because they are keeping you safe with their diligence. Whether born of ignorance or not, it's selfish, pure and simple.

But what if you are worried that you are one of those - or might be - with a genuine bad reaction to vaccination? Don't you have the right to avoid that risk?

No. First, bad reactions to vaccines are both rare and even more rarely as bad as getting the disease you are being vaccinated against. We tend to forget that because, ironically, vaccination has been so successful that incidents of these nasty diseases are themselves rare. Yes, you might be the unlucky one to experience a bad reaction - but you might equally be the unlucky one to get the life-threatening disease if there is a lack of herd immunity. Second, because of herd immunity, people with known bad reactions to vaccination should be even more pro-vaccination! Without the ability to get protection themselves, they are relying on the civil responsibility of others.

I've blogged a few times about Homeopathy, a sham treatment of sugar pills or water with no scientific basis nor evidence for efficacy that (shamefully) is still offered on the NHS in some places. Most homeopathic treatments are targeted at fairly innocuous conditions and are usually sold alongside real medicine, so the main damage done is to your finances (and maybe your pride once you realise you've been scammed). Apart from the diversion of funds from legitimate treatments, however, the damage done to third parties by Homeopaths is minimal.

"First, do no harm."

These words, attributed to Hippocrates, nicely sum up the essence of the "Hippocratic Oath" that (ethical) practitioners of medicine generally swear to. Anti-vaxxers, in contrast, put innocents at risk, including those who have not embraced their twisted and deviant message of lies. For that reason I think, yes, they are worse than Homeopaths - at least if you buy into the hogwash of Homeopathy, you are usually only harming yourself. (Sadly, that's not always the case and reliance on homeopathic treatment can kill children too. I think the effects on society are smaller, though. That said, the lesser of two evils is still evil.)

Evidence-based medicine needs your help!

This is turning into a week of petitions, with another important cause that needs more signatories. This time, is not rhino horn or pangolin scale quackery that's the target, though, it's real evidence-based medicine.

I've blogged before about Ben Goldacre's book, Bad Pharma, and how legal loopholes allow big drug companies to get away with heinous crimes of data massage and selective reporting of clinical trial results. The AllTrials campaign to make clinical trial data more available and transparent is in full swing and has the backing of hundreds of organisations including big names like the MRC, NHS and, encouraging, GSK. This is a big one, not just because the issue at stake is so important to all of us but also because it stands a real chance of success.

They have tens of thousands of signatures at the moment but want to break a million and get support from more international companies and professional bodies. If you haven't signed already, please do. If you have, please encourage others to do likewise. As Ben Goldacre and Tracey Brown wrote in an email recently:

"We are on the threshold of significant change, but we now urgently need help from all of you to make this a reality."

Another small victory in the fight against quackery but the NHS is yet to dilute its shame to Homeopathic concentrations

As blogged recently by Rachel Nesbitt at the Society of Biology, NHS Choices website becomes ‘neutral’ on homeopathy, the NHS Choices website had recently diluted its stance on the inefficacy of homeopathic 'treatments' in response to lobbying.

Happily, in response to a deluge of disgruntled comments, the original text has now been replaced and the site now begins:

"Homeopathy is a 'treatment' based on the use of highly diluted substances, which practitioners claim can cause the body to heal itself.
A 2010 House of Commons Science and Technology Committee report on homeopathy said that homeopathic remedies perform no better than placebos, and that the principles on which homeopathy is based are 'scientifically implausible'. This is also the view of the Chief Medical Officer, Professor Dame Sally Davies."

It's still not all good news, though. As the website explains further down the page:

"It is available on the NHS?
The Department of Health does not maintain a position on any particular complementary or alternative therapy, including homeopathy. It is the responsibility of local NHS organisations to make decisions on the commissioning and funding of any healthcare treatments for NHS patients, such as homeopathy, taking account of issues to do with safety, clinical efficacy and cost-effectiveness and the availability of suitably qualified practitioners.
Homeopathy is not available on the NHS in all areas of the country, but there are several NHS homeopathic hospitals and some GP practices also offer homeopathic treatment."

I'm not sure if this is a deliberate typo - the link at the top of the page reads "is it available..." rather than "it is available..." but, tragically, yes, homeopathy is available on the NHS in some places. With Jeremy Hunt as Health Secretary and pro-Homeopathy Conservative MP Tredinnick on the Commons science committee, I genuinely fear for any future hopes evidence-based science policies in general (badgers beware), and for the NHS in particular.

In case anyone is in anyone doubt as to the driving force behind promoting homeopathy, the final paragraph of the "is it available..." section reads:

"Homeopathy is usually practised privately and homeopathic remedies are available from pharmacies. The price for an initial consultation with a homeopath can vary from around £20 to £80. Homeopathic tablets or other products usually cost around £4 to £10."

That's right. £4 to £10 for some sugar pills. And if you think that homeopathy is harmless, the tell that to anyone duped into giving their child a homeopathic vaccine. (Their opposition to vaccines is particularly ironic, given that the only shred of science that comes even slightly close to homeopathy is that small amounts of a pathogen - an actual vaccine - can potentially give you protection. The mechanism is entirely different, though. (It's real, for one thing.))

If people want to take a placebo, that is their choice - and it might even still work if given explicitly as such - but hiding the fact that a 'treatment' is just a placebo is irresponsible. Promoting it in favour of actual treatments should be criminal. Thanks to the games played by big pharma, the battle for getting decent evidence-based medicine is hard enough. If we can't even stamp out something as obviously nonsense as homeopathy, what hope do we have?

Are big pharma companies worse than homeopaths?

Ben Goldacre is well known for busting Bad Science and promoting evidence-based medicine. His latest book, Bad Pharma, goes beyond quackery and takes on Big Pharma, highlighting what are down-right dangerous practices in the industry. I haven't read the book but his recent article about it in the Business section of the Guardian, "The drugs don't work: a modern medical scandal", makes scary reading. You can also hear him talk about it in a recent Nature Podcast Extra.

It's common knowledge that Homeopathy is pure placebo and literally has no active ingredients. The danger of homeopathy is not that it will do you any harm - there is nothing in there to do any harm - but rather that people will be conned into using Homeopathy in place of treatments that could actually cure them. (Not all conditions can be treated effectively with a placebo and some drugs out there genuinely do work better than placebo.)

The same is not true of drugs. (Or herbal remedies for that matter.) They contain an active ingredient and therefore there is the very real potential for harm as well as the very real potential for an actual positive effect. It is therefore much worse to find out that Big Pharma companies are playing games with the clinical trials and evidence on which doctors base their treatments.

Big Pharma, Homeopaths and woo merchants are all in the business of making money and so it is perhaps not surprising that they use some of the same tricks to sell their wares but what is surprising (to me) is the extent to which the law lets them get away with it and regulating authorities are apparently powerless to do anything about it. Although it does nothing to undermine the need for evidence-based medicine, it massively undermines the access to evidence-based medicine - if the evidence the doctors get access to is hidden or distorted then what's the point?

It's a pretty stark picture. Indeed, Ben Goldacre starts the book thus:

"Medicine is broken. And I genuinely believe that if patients and the public ever fully understand what has been done to them - what doctors, academics and regulators have permitted - they will be angry... I'm going to tell you how medicine works, just over the page, in one paragraph that will seem so absurd, so ludicrously appalling, that when you read it, you'll probably assume I'm exaggerating."

Before I get to that paragraph, I would say that there is at least one other group that will be (and are!) angry - other academics. I am one! I am angry as both a sometimes patient and a scientist. (And, when it comes to medicine, a member of the public!)

The reason this angers me as a scientist are two-fold. First, the trivially obvious reason: such flagrant abuses of methods that are supposed to provide objective evidence not only undermine public faith in medicine but they undermine faith in science as a whole. (Not, sadly, that non-medical science is immune to these abuses but they generally seem to get identified by other scientists, who are all skeptics by nature, and rarely have the same capacity for harm.) The second reason is that it is not just doctors and patients that use these data. There is a lot of effort being put into mining existing drug actions and side effects to identify novel treatments (e.g. "network medicine") - often by people who do not stand to make money from the discovery. The weakness with all of these approaches is that "rubbish in, rubbish out" and if the pharma industry is systematically sabotaging the data that the scientific community are using for such endeavours then a lot of good scientists are wasting valuable time and money, not to mention missing important connections that could result in genuine treatments.

But now for that paragraph. You can read the full paragraph using Amazon's Look Inside feature but here's a taster:

"Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they perfectly entitled [legally, not morally - RJE] to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on is a drug's like, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated in a distorted fashion..."

The rest of the paragraph - and, judging by the intro, the book - is not much cheerier. It's no wonder he says that Medicine is broken. When I am feeling brave, I think I will order a copy for my kindle.

Nevertheless, I think there is something worth pointing out or reiterating: this is a problem of implementation, not theory. It is not that drugs cannot or do not work - some do and we have well-designed and well-executed studies that show this. (Generally, the older ones, when Pharma was not so desperate or, perhaps, cynical and there was more low-hanging fruit.) It is not that medicine should not be evidence-based or that we do not have methods for gaining that evidence. This does most emphatically not mean that homeopaths and woomeisters were right all along. The fact that some of their conspiracy theories have a semblance or truth about them does not mean that their pseudoscientific nonsense suddenly gains merit.

I'm not really sure what can be done about this but the first step on the road to recovery is admitting that you are sick, and it certainly cannot be swept under the carpet. Part of me still hopes that Ben Goldacre's new book is an exaggeration (or, at least, concentrates on all the negatives) but can we really take that chance? However widespread the problem in terms of current drugs that are affected, we must make some changes to things that are clearly broken. Making the clinical trials process entirely independent of drug companies would be a start and forcing drug companies to publish all of their data from trials for analysis by independent experts seems like such a no-brainer that my mind still boggles a little at the revelation that it isn't so.

Should it be needed, it's just another indicator of the dangers of privatising health care. When the bottom line is money not effectiveness, you know you are in trouble.

The (lack of) evidence for Homeopathy

Yesterday, I mentioned the House of Commons Select Committee (Science and Technology Committee) Evidence Check 2: Homeopathy.

It's quite a long report, so I think it worth highlighting a few of the conclusions here:

54. We conclude that the principle of like-cures-like is theoretically weak. It fails to provide a credible physiological mode of action for homeopathic products. We note that this is the settled view of medical science.

61. We consider the notion that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be scientifically implausible.

70. In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos. The Government shares our interpretation of the evidence. We asked the Minister, Mike O'Brien, whether the Government had any credible evidence that homeopathy works beyond the placebo effect and he responded: "the straight answer is no".

77. There has been enough testing of homeopathy and plenty of evidence showing that it is not efficacious. Competition for research funding is fierce and we cannot see how further research on the efficacy of homeopathy is justified in the face of competing priorities.

82. We do not doubt that homeopathy makes some patients feel better. However, patient satisfaction can occur through a placebo effect alone and therefore does not prove the efficacy of homeopathic interventions.

101. We agree with Professor Ernst and the RPSGB. For patient choice to be real choice, patients must be adequately informed to understand the implications of treatments. For homeopathy this would certainly require an explanation that homeopathy is a placebo. When this is not done, patient choice is meaningless. When it is done, the effectiveness of the placebo—that is, homeopathy—may be diminished. We argue that the provision of homeopathy on the NHS, in effect, diminishes, not increases, informed patient choice.

109. When the NHS funds homeopathy, it endorses it. Since the NHS Constitution explicitly gives people the right to expect that decisions on the funding of drugs and treatments are made "following a proper consideration of the evidence", patients may reasonably form the view that homeopathy is an evidence-based treatment.

Conclusions

110. The Government's position on homeopathy is confused. On the one hand, it accepts that homeopathy is a placebo treatment. This is an evidence-based view. On the other hand, it funds homeopathy on the NHS without taking a view on the ethics of providing placebo treatments. We argue that this undermines the relationship between NHS doctors and their patients, reduces real patient choice and puts patients' health at risk. The Government should stop allowing the funding of homeopathy on the NHS.

111. We conclude that placebos should not be routinely prescribed on the NHS. The funding of homeopathic hospitals—hospitals that specialise in the administration of placebos—should not continue, and NHS doctors should not refer patients to homeopaths.

I'm not sure whether the NHS still funds it but I am sure that it shouldn't. It appears, however, that BUPA are no do know is that BUPA no longer do, at least for its "bupa Select" cover. Point six on their notification for change states:

6. Complementary medicine practitioners, homeopathy
 We no longer provide cover for homeopathic treatment.

Homeopathy: there's nothing in it.

UK Homeopathic manufacturers might have to sell their sugar pills as... sugar pills!

If I had to draw up a top three list of irrational nonsense that makes me fear a little for the future of humanity, Homeopathy would probably be on that list. It embodies everything that is wrong about "woo" - disproven bunk supported by liars spouting pseudoscientific nonsense in order to extract money from the gullible, credulous and/or desperate.

It should be illegal to pretend that sugar pills or water are medicine. Happily, it turns out, it is! In a great Guardian piece yesterday - Homeopaths offer to rebrand products as 'confectionery' - "The Lay Scientist" Martin Robbins reports that:

Under current UK law*, it is an offence for a lay homeopath to supply or sell unlicensed homeopathic medicines for which they do not hold a certificate of registration from the MHRA. Unlicensed remedies can only supplied by those with prescribing rights - medical doctors or registered pharmacists - and then only after a face-to-face consultation with the patient. Since very few homeopathic products are licensed, this means a huge swathe of Big Sugar's products are, in theory at least, not legal.

*The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, as amended in 2005.

Furthermore, under the Human Medical Regulations Act, there is an obligation to enforce this law if a complaint is made - and, thanks to Simon Singh and friends, complaints are being made! It's still not clear to me how much actual fallout from this there will be but it's definitely a step in the right direction.

Martin Robbins ends his piece with this great line:

"I've got no problem with people buying and selling homeopathic remedies for their aches and sniffles. Just don't pretend it's a real medicine, and don't persuade people it can treat dangerous diseases. Is that really so much to ask?"

I hope not, Martin. I really hope not.

(And in case you are under the impression that Homeopathy might be effective, read the House of Commons Select Committee (Science and Technology Committee) Evidence Check 2: Homeopathy.)

[Edit: I was obviously having a brain-dead moment when writing this and erroneously called Martin Robbins, Tim. Doh! Sorry, Martin.]

Busted faith healers try to hide behind "religious persecution" smokescreen

There's been a bit of a furore over the past couple of days after a brave citizen reported the Bath contingent of the "Healing On The Streets" (or "HOTS") movement to the Advertising Standards Authority (ASA) for making the unsubstantiated claims that God could heal you (on the street) through them. You can read the actual account of the complaints made at the blog of the complainant, Hayley Stevens.

Hayley is an atheist but, more importantly, a skeptic and complained on skeptic grounds that HOTS were misleading people with claims that cannot be supported by evidence and could detrimentally influence the weak and vulnerable away from authentic medical treatment. ASA agreed and have ruled that HOTS have to remove these claims from their advertising material.

Do HOTS respond with tales of clear and unequivocal healings performed by HOTS teams? No. Of course, HOTS had the opportunity to counter the complaint with convincing evidence that supports their claims but they have none. (Their website contains "Hot Stories" of successful healings - presumably their most convincing stories. Judge for yourself how anecdotal they both(!) are. Why is it that God never regrows an amputated limb or anything else unambiguous and unattributable to placebo?) Instead, they try to deceive and grope for support by playing the "religious persecution" card, totally inappropriately, including a news article disingenuously entitled "UK Advertising Standards Authority try and stop HOTS Bath from sharing the Gospel!" 

Well, if HOTS cannot - or will not - tell the difference between "sharing the Gospel" and making unsubstantiated claims, then I think that speaks volumes about both the evidence for their Gospel message and their true motivation for "healing" strangers on the street. (I thought the Gospel was about forgiveness from sin, not healing from physical ills. I obviously did not pay enough attention in Sunday School.)

It's not just HOTS, though. Bible Reflections also ran the story, saying that the ASA "would now like us to recant our Christian faith in the Bible". No, they wanted you to agree to "not make claims which state or imply that, by receiving prayer from [HOTS] volunteers, people could be healed of medical conditions." They are welcome to believe it, they are just not allowed to push those beliefs on others without evidence. Like HOTS themselves, BR went for a misleading headline, claiming that ASA were "trying to stop Healing on the Streets". Again, no. It was not trying to stop them entirely, just to stop their unsubstantiated claims.

The complainant - an individual, not a group, as claimed by Bible Reflections - was not complaining on anti-Christian grounds but rather on anti-non-evidence-based medicine grounds. And quite rightly, too. Anecdotes are not evidence. If people wish to seek out faith healing then that is their business. However, accosting the vulnerable in the street and encouraging them share personal matters with strangers in the hope of unproven potential to be healed is a different matter, and wrong. It would be wrong if it were Homeopaths, wrong if it were psychics and wrong if it is faith healers.

But isn't it all harmless, even if it doesn't work? HOTS are not making money or trying to con people, like psychics or homeopaths.

Well, in some ways, I think faith healers are even worse. HOTS may think that faith healing is harmless because they believe it. But who do they believe God heals? Those with faith, presumably. And what is one of the "reasons" that faith healing does not "work" when it fails? Insufficient faith. How do you prove your faith in God's healing? By avoiding conventional treatments. Sure, HOTS may not explicitly encourage this but it would be very naive to believe that it is not a subtext. Almost as bad, what's the other "reason" it doesn't work? "God's will." Given that most people are not healed - either that or their "Hot Stories" editor needs sacking - what HOTS are really doing is going around implying that people are sick either because they lack faith or it's God's will. That's wrong on many levels.

No one is asking you to "recant your faith", HOTS, just to stop meddling and misleading people with your unproven beliefs. I've seen these people before in Winchester and felt annoyed but not had the guts to do anything about. Well done, Hayley Stevens.

Science nay-sayers, why the rush?

I get annoyed at the repeated premature announcements that scientific breakthrough X or Y has not yielded the benefits it promised. This week's Nature Biotechnology, for example, features an editorial entitled "What happened to personalised medicine?" with the tag line:

"Personalized medicine falls a long way short of the predictive and preventative healthcare paradigm it once promised."

Notice the past tense? "It once promised." Personalised medicine as a concept has failed, apparently.

The article then says:

"In some respects, 2011 was a banner year for personalized medicine. Academic medical centers began to demonstrate the feasibility of routine clinical genotyping as a means of guiding treatment selection in oncology. The US Food and Drug Administration released its companion diagnostics draft guidance. Sanofi, Pfizer and AstraZeneca signed deals with Medco and WellPoint for access to their large databases of patient data. Cancer Research UK's Stratified Medicine Programme was launched to demonstrate how genetic tests can be used to match National Health Service cancer patients to treatments. And two new targeted oncology therapies, Roche/Genentech's Zelboraf and Pfizer's Xalkori, were approved in conjunction with companion diagnostics for BRAFV600E and structural variants of anaplastic lymphoma kinase (ALK), respectively.

All are no doubt important steps, but illustrative of a rather pedestrian form of progress in personalized care rather than a march to the future."

So, it's not that it's failing to deliver anything. It's just happening too slow. The same thing happened with the Human Genome Project (HGP). This was "completed" less than a decade ago but people have already proclaimed that it has failed to deliver because we haven't been overwhelmed with a deluge of new HGP-derived drugs. The average drug development time is 10-15 years, I think, and that's when you already understand a fair amount about the target. So, even if the genome project truly was "complete" then it is still unrealistic and unfair to have expected it to already have yielded dozens of new therapeutics, even if you ignore the fact that novel targets arising from the genome project are, by definition, going to start off with practically nothing known except the sequence.

Annotation is still ongoing but the current state is over three billion nucleotides, approx 21,000 high confidence protein-coding genes plus over 47,000 gene predictions. This is a lot of data to deal with and it is naive beyond belief to think that the "answers" are just going to magically fall out in a few years. Going back to personalised medicine, the current Ensembl release has over 45 million variants and even this is not enough data. To really make sense of the role of genetic variants, we need a lot more genomes from both patient and control populations, and these patient populations need to be sensibly stratified by, e.g. treatment response. Such data is beginning to come but it is still early days, plus we still don't really know how to analyse all this data.

Biology is flaming complicated and the more we learn, the more messy and complicated it gets. Expecting us to unlock the secrets of first "The Human Genome" and then human variability in a few years goes beyond naive or arrogant, it's ridiculous.

I'm a big believer in The Human Genome Project and it really has changed the world already, even if its "promise" in terms of new drugs etc. will take many more years to be realised. (And this realisation will probably come mostly from Academia rather tha pharma.) I'm also a big believer in the concept of personalised medicine - the tailoring of treatment to the individual based on their particular genetic background. The fact is, however, that whilst this is totally the right road to be heading down, it's going to be a very long and windy road, no doubt with a few wrong-turns and dead-ends along the way.

To be fair, the rest of the editorial does then raise some pertinent points about things that need to happen to facilitate our journey down the road towards personalised medicine. These include better incorporation of the human "microbiome" - in sheer numerical terms, we have far more bacterial cells, genes and proteins in our bodies that human ones - and increased incentives for pharma companies to develop diagnostics as well as treatments. I just wish that the whole thing hadn't been given such a negative spin from the outset. It seems that with live in a world where everything needs to be over-hyped initially and then over-criticised when it doesn't live up to the over-hyping. I say, stop that: it's silly.

Even by Homeopathic standards, this is stupid

This story is covered much better at sciencebasedmedicine.org but it's so gob-smacking, I just had to write something. It's seems that the industry does a good job of convincing people that homeopathy is the same as "natural" or "herbal" remedies. It isn't. It literally has no active ingredients and apparently they don't like little people pointing this out.

Basically, a large multinational corporation (Boiron) is threatening a lone Italian blogger for pointing out that one of their products did not contain the active ingredient they claimed. No surprises there, given that homeopathy is expensive water and has no active ingredients of any kind. (According to geeks who have done the maths, the stated dilution is approx. equivalent of diluting one teaspoon of substance in a volume of water the size of the Universe.)

What is more surprising is that the "active ingredient" - oscillococcinum - almost certainly does not even exist before it is diluted! All the evidence points to it being an early Twentieth Century microscopy artefact. There is certainly no evidence that it does anything, let alone cause the symptoms of flu, which is at the heart of Homeopathic nonsense (despite an utter lack of any theoretical or empirical scientific basis, remember). Naturally, as even the existence of oscillococcinum is unproven, the idea that the duck liver extract being diluted to non-existence is high in oscillococcinum is pure speculative fantasy.

Even by Homeopathic standards, oscillococcinum appears to be sham. While every single step of the Homeopathic method lacks evidence and totally contradicts modern scientific understanding, oscillococcinum seems to contradict the homeopathic principles too. No wonder they don't want anyone drawing attention to it.