In Australia, the east coast experienced the worst floods since 1974, quickly followed by Cyclone Yasi ravaging as far inland as Mount Isa. Then there was the terrible earthquake in Christchurch where many died across the pond. And then on Friday a massive 9.0 earthquake exploded under the North Pacific Ocean, sending a huge tsunami smashing into the north-east coat of Japan.

The Japanese are suffering terribly, not just because tens of thousands are missing feared dead, but they also face bitter cold as snow is dumped on the devastation. And even worse, 4 nuclear reactors which took the brunt of the tsunami and earthquake are now at risk of meltdown. Although the reactors are built to withstand earthquakes, the combination of such a huge event coupled with a massive tsunami wiped out back-up systems required to keep the fuel rods cool. As water levels dropped the rods heated up, some producing enough hydrogen gas to cause explosions and subsequently the release of radioactive gas into the air.

Authorities are madly dumping sea water from helicopters onto the rapidly heating fuel rods, and as a precaution have set-up an exclusion zone in a 30 km radius around the plant. However, if the meltdown cannot be prevented, there is a risk of the release of radioactive gas clouds which could drift into populated areas.

Enter the vultures.

Several days ago Australian Skeptics Vice President Richard Saunders circulated an email from Homeopathy Plus! describing homeopathic remedies for radiation sickness and poisoning. It described how homeopathy offered “key remedies that have been used either in research or historically to prevent or treat radiation poisoning..”.

Two emails sent on March 13th and the 16th described;

“If at risk of radiation exposure, any one of the above remedies may be taken as an emergency response, three times a day in a 30C potency.”

The remedies referred to are cadmium iodide, cadmium-sulph, phosphorus, strontium-carbonicum and X-ray.

That’s right, homeopathic preparations of X-rays.

But before you get worried that more X-rays might not be just the best thing to treat radiation burns, let’s take a look at precisely what 30C means. This is a common homeopathic dilution – one you might find on your local pharmacy shelf and means the original substance has been diluted 10 to the power of 60 times (in simple terms, 1 with 60 zeros after it). At a dilution this great, in order for you to come into contact with even one molecule of the original X-rays, you would have to give two billion doses per second to six billion people for 4 billion years. Or to put it another way, a 30C dilution is the equivalent of placing 1 mL of liquid into a cube of water measuring a million million million metres per side.

Impossible and also preposterous. But there’s more.

“If radiation sickness has developed, your homeopath is the best person to advise on treatment dosages and potencies as these will depend on the symptoms you are experiencing and their severity.”

But not just any homeopath. Apparently some people are confused by the number of remedies being offered by different homeopaths. (Apparently they can’t agree amongst themselves).

But never fear! Homeopathy Plus! will only recommend you;

“remedies whose effects are also supported by research and/or confirmed with clinical successes as reported by doctors and physicians dealing with radiation exposure during the Great World Wars.”

But what if you can’t get your hands on a super dilute one to the bajillion dilution of X-rays? No worries, you can take a more concentrated dose of X-rays but you just need to take it more frequently.

Yes, you read that correctly, if the preparation is more concentrated you just need to take it more often.
According to the helpful HP! Newsletter, this means

“…taking a more frequent dose for lower potencies (4-6 times a day) and a less frequent dose (1-2 times a day) for higher potencies.”

This is because homeopaths believe that the more dilute the preparation, the stronger it is. You couldn’t make this stuff up. Well, actually you could but no-one would believe you.

So as you might expect HP! have copped a bit of flack for this irresponsible nonsense. The story was reported in The Australian newspaper, on The Punch website, by Phil Plait in his Bad Astronomy blog, by Brian Dunning on Skepticblog and by Ben Radford on the Discovery website. Adam Cresswell from The Australian asked some experts about the claims that homeopathy can treat radiation burns and got a predictable response –

Victorian GP Bill Williams, who is also a nuclear safety expert, said there was “absolutely no evidence” for any of the remedies being promoted by HP! being useful in treating radiation sickness.

“It’s not really very helpful for people to be promoting treatments in a dire situation like this, which could give people false comfort,” Dr Williams said.

Nuclear radiologist Peter Karamoskos said the claims that were made by Homeopathy Plus were “rubbish”.

“Such claims are dangerous in that it might compromise proper treatment and give false security.”

Sadly this is not the first time HP have spouted rubbish on the unsuspecting public. The Homeopathy Plus newsletter and clinic are both run by homeopath Fran Sheffield who is also good mates with the AVN (birds of a feather and all that.)

In 2010, the TGA instructed Ms Sheffield to remove claims that homeopathy was an effective substitute for vaccination from her website and publish a retraction. She refused to do so on the grounds that she didn’t agree with the decision. And, as with approximately 30% of those served with a TGA retraction order, nothing was done to enforce the finding. In fact the TGA told ABCs Lateline programme that no legal action has ever been taken over non-compliance. Which makes the complaints system look like a complete farce.

Indeed following the Lateline report Fran Sheffield jumped a flotilla of sharks and published a piece on her website called “Lateline: can homeopathy safely protect against epidemic and infectious diseases? Can homeopathy treat serious diseases such AIDS and cancer?”. It was a veritable Gish Gallop of references purporting to show that indeed, it can. So, not only did she refuse to remove false and misleading information from her website, when challenged she simply added more.

A few months prior she sent out an email alert entitled “homeopathy as good as chemotherapy for breast cancer and non-toxic”, based on a paper published in The International Journal of Oncology. Firstly the paper had not made such a claim – it was only a cell study – and secondly it was a terrible piece of bad science chock full of dodgy data. So much so that one of the authors left a comment on my blog where I had taken the paper to pieces, dissociating herself from the work saying “…I asked to not be included (on the paper) because I did not think it was a sound study..”

Still, Ms Sheffield continues to claim that magic vibrating water can cure everything. In a flyer sent out for a workshop last year she stated “homeopathy works for autism, infections, anxiety, allergies, insomnia, coughs and colds, depression, irritable bowel syndrome and much much more..”

Sorry Fran, but there is no evidence that homeopathy works for anything, except maybe for hangovers. I love a nice cold drink of water when I’m hungover. But claims that homeopathy can be used for the treatment of radiation burns or illness are complete rubbish and prey on the vulnerable and desperate.

The full emails can be found here and here.

Fran Sheffield runs the woo-fest website that is Homeopathy Plus! The same website that was the subject of a recent Therapeutic Goods Administration (TGA) investigation which found her website contained misleading information. Including such gems as “homeopathic immunisation” is as effective as vaccination and that homeopathy can treat cancer, AIDS and other terminal diseases.

Regular readers might remember her being responsible for the e-newsletter alerting us to the “homeopathy cures breast cancer study” which myself and David Gorski subsequently took to pieces. Sadly, only a few weeks ago this study ended being tabled as evidence for an EDM submitted by UK MP David Tredinnick (the one who believes blood does not clot under a full moon therefore surgeons do not operate) in the House of Commons. Thanks to the quick action of Simon Singh and Evan Harris, the EDMs were modified pointing out the utter fail that this study is, including the fact that one of the authors publicly dissociated herself from the study in a comment left on my blog.

As a result of an investigation into the HP! site, the TGA recommended Fran Sheffield publish a retraction in a prominent position on her website. But as is her want, she has refused to do so and since the TGA have no powers to enforce the ruling, so her website remains unchanged.

Following the finding by the TGA, Steve Cannane’s Lateline did a story where he interviewed Fran Sheffield about her reasons for not putting up the retraction. It was clear to me from the story that she sincerely believed the nonsense spouted on her website, thus saw no reason why she should conform with a TGA ruling to the contrary.

But it seems that since the TGA ruling and Lateline story, Fran has made even more outrageous claims and jumped the shark.

She even wrote a response on her website to the Lateline story where she Gish galloped references in support of homeopathy as an effective treatment for cancer and AIDS.

In her most recent flyer (below) for a seminar running in early August she claims homeopathy works for fractures (ummmm, okay), fear of flying (??), workaholism (huh?) and nose bleeds (I have one from reading this BS).

To be fair, she does get some things right. She says homeopathy works for hangovers – well sure it does, a nice big glass of water can be great for dehydration resulting from excessive alcohol consumption. And homepathy is good for plants – I add homeopathy/water to my plants water about once a week, they love it!

But seriously, Fran Sheffield, if I fractured a bone in my body, I reckon the first place I would go is a hospital, for some good old fashioned plaster – not run my leg under the tap. This information is wrong and dangerous. About the only thing homeopathy is good for is dehydration. And the TGA sits back doing nothing. Disgraceful.

Speaking of homeopathy for burns, Arnica Montana made these claims for the victims of the the Bali bombings and the Victorian bushfires back in February 2009.

When this appeared in my inbox yesterday, courtesy of Richard Saunders (who was kind enough to ask me if I was sitting down first) I initially *facepalmed*, then sought about getting the original paper where this apparent break through research had appeared (thanks to @xtaldave for the full text).

The paper that had apparently found homeopathy to be as effective as chemo for breast cancer (according to Homeopathy Plus!, yes those guys), was published in the International Journal of Oncology* and entitled “Cytotoxic Effects of Ultra Diluted Remedies on Breast Cancer Cells.” (Click the link for the full pdf of the study).

The paper examines the effects of ultra-dilute remedies (read:homeopathy) on the induction of cell death in two cancer cell lines (commercially available MCF-7 and MDA-MB-231) and one immortalised control cell line, (HMLE).

The authors use several remedies already in use for the treatment of human breast cancer developed at the P. Banerji Homeopathic Research Foundation in India, Kolkata;

Carcinosin, 30C; Conium maculatum, 3C; Phytolacca decandra, 200C and Thuja occidentalis, 30C (for an explanation of how dilute these remedies are see here).

All remedies were diluted in 87% “extra neutral alcohol” and succussed, including the alcohol used as the control solvent.

The authors analysed each remedy with high performance liquid chromatography (HPLC) to look for differences, then measured cell death in cell culture in response to increasing doses and increasing time of incubation with each remedy. These measures include the MTT assay for cell viability, Annexin V and PI for apoptosis, FISH for DNA breakage and Western blots to measure activation of cell cycle proteins.

Technically the paper is quite well written. The problems lie with the data. And these problems are so massive, I wonder how they got by the reviewers. I don’t know whether they were dozing when they reviewed this paper, but I could immediately see some big fat gaping holes in their results.

First up a few pointers;

“The experiments were conducted in triplicate and repeated at least twice in each case of remedy”

This would not get past me. It is accepted scientific convention that experiments are done at least three times (not two) and also in triplicate, giving you a final “n” number of 9. These studies were done in cell culture, meaning there is plenty of material for experiments to be repeated as many times as you wish. So why were they only done twice? Three is convention because it gives the study more statistical power.

Ah statistics, huh?

There is a distinct lack of statistics in this paper, by which I mean there are none at all. As my friend Jo said; “Nary a p-value nor a confidence interval to be seen”. Which begs the question, how can you get a paper accepted in a peer reviewed journal without doing an statistical analysis?

Really? No, I mean REALLY? This is why I suspect the reviewers were dozing or drunk.

And by not doing any statistical analysis, you can not make any statements about whether the treatments are different to each other. Statistics uses algorithms to calculate mathematical differences with a degree of confidence (usually 95%) so that we don’t rely on visual interpretation, which is notoriously unreliable. But this doesn’t seem to have bothered these authors, or the reviewers.

So let’s look more closely at the results.

Firstly the HPLC.

Oh wait a sec, there are no results shown for HPLC. And neither do the authors say “no results shown”. They just make some rather confused statements about what they think they saw and move on. What?! I need to see the chromatograms. What possible reason could they have for not including this data, especially when they go on to describe it so badly in the text.

“All four remedies had very similar HPLC chromatograms to each other, with only trace amounts of limited number of peaks. They were not significantly distinct from the solvent and they lacked the distinct peak seen in the solvent.

So, this means that all the remedies were the same, ie. no different to the solvent and no other peaks indicating any ingredients. But then they contradict themselves by saying that the remedies did not have the solvent peak? Fail.

And then;

“The chromatogram of the untreated and treated solvents appeared identical, indicating that succussion did not cause chemical changes in the solvent.”

Okay, but don’t some homeopaths claim that succussion does have an effect on the chemical structure of the water/solvent? Isn’t this how they explain that homeopathy works? I can only guess SINCE WE CANNOT SEE THE CHROMATOGRAMS, but what you are saying is the remedies and the solvent were exactly the same, meaning they are solvent.

No surprises there.

What about the cell death studies?

So let’s look at the cell death studies since these constitute the crux of the study’s aims. That is, to determine if these ultra dilute remedies can induce cell death in cancer cell lines.

So here we have results for all three cell lines, two cancerous and one control, and they are all treated with a control (the 87% alcohol solvent) or the remedies and death measured by MTT assay. Here’s how they describe it in the text;

“Interestingly, the inhibitory effects on cell viability of the remedies in both the MCF-7 and MDA-MB-231 cells were distinctly greater for each of the doses tested than those seen in cells treated only with solvent.”

Which translates as the treatments killed the cells better than the solvent alone. Okay, so it looks like it did when you eye ball the histograms, but you have no evidence for this – you didn’t do stats, therefore you cannot say this! Sheesh, where did you learn to write science?

But why not keep the fail going;

“MCF-7 cells were found to be more sensitive to all four remedies than the MDA-MB-231 cells”.

Again no statistics, so this statement cannot be confirmed. When you do science properly and you run statistical analysis, you are entitled to say, “MCF-7 cells were found to be significantly more sensitive to all four remedies than the MDA-MB-231 cells”.

Unless you’re these authors, then you just get a great big FAIL stamp on your work.

Also note that they state that the control treatment (that is the solvent) also induced cell death in all cell types;

“As shown in Fig. 1A, the solvent reduced the viability of all three cell types; the overall reduction in cells at different doses of solvent was about 30% for MCF-7, 20-30% for MDA-MB-231 and 20% for HMLE cells.”

Ummm, hold on a sec.

This is your control treatment, which means it should not be causing cell death. It is designed to be inert, functioning as a carrier of your treatment, in order that you can measure the impact of the treatment alone. If your solvent or vehicle is killing your cells you have a fundamental problem. You need to go back to the drawing board and find a different solvent to deliver your treatment.

This is a very big problem right here.

If the cell death induced by the solvent is significant, then the rest of the paper is worthless. But because there are no stats here, there is no way to tell if death by the solvent is significant. According to the above statement, the alcohol killed ~30% of the cancer cells compared to no treatment at all. Although this effect was increased when the treatment was present, there remains a large problem with your model if your solvent is killing the cells.

Perhaps this explains why there are no stats in this paper? Because they may in fact show that the “inert” solvent also significantly kills the cancer cells? Once again, there is no way for me to know this without access to the raw data, or the statistical analysis.

Man, how the hell did this embarrassment get accepted?

Well now that I have revealed a fundamental flaw in this tripe I have lost the will to continue. There is much more fail herein however, I mean we are only at Figure 1 remember.

So I will cover just a few more things that are also glaringly obviously wrong with this paper, then I will send a large bottle of 87% alcohol to the editorial board and encourage them to keep up the good work of smiting the peer review process and science in general.

General lack of quantitation of results in this paper.

Figure 3, excerpt from Frenkel et al., showing damage to DNA.

Figure 3 (left) shows fluorescent microscopy data for DNA breakage as measured by FISH assay. But where is the quantitation of this data?

The authors show a representative image for each treatment, and this is usually acceptable if you then measure large numbers of cells and report on such changes with numbers (see below).

Dunlop et al., in press. Panels are representative DAPI/FITC overlay images of at least 10 images taken from triplicate wells. Histograms are mean + SD of 3 independent experients, incubations in triplicate, n = 9, p < 0.001 1-way ANOVA. Tukeys post-hoc analysis.

Further, even in the fluorescent images the authors only show a maximum of 14 cells. What the hell can you glean from 14 cells? They even say;

“At least 200 cells from treated and untreated samples were analyzed for mitotic index and telomeric DNA signals with a Nikon Eclipse 80i microscope equipped with fluorescence attachment and a Photometrics CoolSNAP HQ2 monochrome digital camera.”

So where is this data? Not in this paper, I can tell you that.

Next up Western blots.

Then they move onto Western blots. Actually this looks like the most resolved part of the paper. They have normalised everything to beta-actin as convention goes, and they have indicated the time of exposure to treatments. But as I mentioned earlier, if their control treatment 87% alcohol, is killing cells, then what can we glean from this data? Well not much except the effect could be an additive effect of the alcohol and treatment. There is no way to differentiate the impact of the treatment versus the control.

Flow cytometry, not quantitated either.

Sigh. I spend most of my days doing flow cytometry, so I am pretty familiar with how it works and what are the accepted ways to present the data. This is not one of them.

Figure 5, excerpt from Frenkel et al.,

The assay they use (Annexin V and PI) is a common one and I use it often. Standard procedure is to count ~10,000 cells for each condition, then plot your results on a graph, like this (see left below).

Dunlop et al., in press. Flow cytometry analysis of lysosomal destabilisation in THP1 human monocytes with acridine orange as a probe. Mean & SD of three independent experiments, incubations conducted in triplicate (n = 9), ** p < 0.01, *** p < 0.001, 1-way ANOVA, Tukeys post-hoc analysis.

You might also show your scatter plots as they have done above, as a nice visual demonstration of how the cells respond to the treatment, but this is not quantitation.

I’m going to stop there. I won’t even bother dealing with the discussion and conclusions, because by my analysis, they are based on flawed data.

One thing I will say about Homeopathy Plus! yelling “Homeopathy as good as chemotherapy for breast cancer” is not a conclusion you can draw from this study.

For all the reasons I have addressed above as well as the really obvious point that these studies were conducted in cell culture. This is a very different situation to a whole animal.

Cells bathing in a bath of homeopathy is very different to the processes which occur in vivo, for example the treatment must survive the low pH of the stomach, cross the gut, escape metabolism in the liver and get to the site of the cancer then do it’s job. This is a very complex process and very difficult to control. Studies in cell culture can provide data about the mechanism of action of a compound, but rarely do they relate to the processes in a human.

Never extrapolate results from a culture dish to a whole animal. You will undoubtedly be wrong and look like a fool.

Ooh, did someone say Homeopathy Plus!?

Listen to Fran Sheffield from Homeopathy Plus! talk about how homeopathy works here (mp3, 3:19).

*The International Journal of Oncology, impact factor 2.234, fail factor 10^23.

In what seems like a match made in hell and should send shivers down the spine of any rational sensible science based person, the AVN is teaming up with super quack homeopath Fran Sheffield to host a webinar entitled “The Homeopathic Treatment of Autism”.

For the first time, it is free to register for this webinar which is sponsored by the AVN and scheduled for December 2nd from 7 – 9 pm AEST.

I encourage you to sign up here and consider live tweeting the webinar as it happens, using the hashtag #autismAVN. If you do plan to live tweet, leave a message so I can gather up your tweets and publish them as a blog post after the event.

By the way, I was alerted to this event via the Homeopathy Plus e-newsletter which you can also sign up to here.

Readers will recall that the AVN and their president Meryl Dorey were awarded the 2009 Australian Skeptics Bent Spoon award as “the perpetrator(s) of the most preposterous piece of paranormal or pseudo-scientific piffle”. You can read all the details of the reasons why they were given this prestigious award here.

Fran Sheffield has also had a complaint lodged about some hocus-pocus claims made on her website to the TGA in Australia. One regarding nonsense pertaining to the effectiveness of homeopathic immunisation for meningococcal disease is currently languishing with the TGA as they go about dealing with threats to public safety at a glacial pace.