This is a slightly edited transcript of a contribution I made to Pod Delusion 73.

The 10:23 campaign to raise awareness of the quackery that homeopathy is went really international this year.

In 2010 I had spearheaded the local event in Leicester. It seems my “crisp Teutonic accent” came across quite strongly in our YouTube video back then. At least this is what one of the commenters wrote. He essentially invoked Godwin’s law by comparing me to my infamous German ancestors and their “failed attempt to take over Britain and tell us what to do”. Only when he wrote “we won’t let you besmirch one of the best British medical traditions”, I couldn’t help myself replying “I am sorry to say this, but this quackery is actually German…”.

Germany is a big market for homeopathy and alternative medicine as a whole, and some of the large manufacturers are also based here. Homeopathy has recently come under scrutiny in the national press, with front-cover features in respected weeklies like SPIEGEL and STERN, or newspapers like Süddeutsche Zeitung or ZEIT. However, the German homeopathy lobby is strong, and I wouldn’t be too surprised if the ridiculous exception of homeopathy from European drug licencing rules was partly due to German intervention as well. But I will come back to that.

I spent the 10:23 weekend at QEDcon in Manchester and took part in the overdose there, but tried to keep up to date with any news on the German groups, especially in Cologne and Essen, which both are close to where I live.

One of the very first news articles I found was from the Kölner Stadtanzeiger, Cologne’s largest local newspaper. The coverage was appalling. The headline reads “A show by globuli critics”. At least they mention that the event is a rather “satirical” one, and they explain the meaning of the 10:23 name, Avogadro’s constant and hence that “there is likely nothing of the original substance left in homeopathic remedies”.

However, the overall tone of the article suggests that the skeptics are a small group of paranoid show-offs who are up to something potentially dangerous. They quote the “BfArM” – Germany’s Federal Institute for Drugs and Medical Devices, which oversees drug licencing. BfArM says they generally “ask patients to use drugs responsibly” and that “calls to overdose on drugs are not helpful for raising awareness”.

The article then goes on to quote the “Karl and Veronica Carstens Trust”, an alternative medicine lobbying organisation. The trust suggests that the call to overdose on homeopathic remedies could actually constitute an unregistered clinical trial under German legislation, even if a very badly designed one. They immediately bring up the usual claims why such an action does not prove anything anyway, that homeopathy does not work on healthy people, that it requires individual testing, and so on. In a nutshell, “according to scientific criteria, 10:23 does not prove anything, and therefore does not help public information either”. And they finish with stating that the sentiment that scientific research would only yield negative results for homeopathy, is false. Period.

Brilliant. An article that (a) misrepresents what 10:23 is about, (b) only gives the side of a homeopathic lobbying organisation, and (c) seems to have been written without talking to either the organisers or any further research in the matter.

Anyway, what immediately intrigued me was the comment of the BfArM, and the notion that – under German legislation on clinical trials – 10:23 campaigners could be in trouble. This sounds ridiculous to anyone who actually knows what 10:23 is about, but we have seen worse when administrative bodies decide to rather regulate the scientists than the quacks.

With a quick Google search, you can discover that the quotes of the BfArM actually come directly from a press information published by said Karl and Veronica Carstens Trust. This suggests that Irene Meichsner, the journalist, more or less copied this press information, instead of contacting the BfArM herself for comments.

The press information states that homeopathic remedies are subject to German Drug Laws, and that the BfArM actually investigates whether 10:23 constitutes a clinical trial that requires prior registration, which could lead to further actions to ensure the safety of patients.”

I will spare you the rest of the press information, which is just an extended version of “this is why 10:23 is not feasible to properly test homeopathy” and “homeopathy works, here is our own list of positive studies”.

So, the BfArM investigates 10:23? This is worse than I thought. Has anyone followed up on this? Oh yes - Ali Arbia of the zoon politikon blog at ScienceBlogs Germany.

Based on the vague and quite general BfArM quote, Ali quickly assumed that this is just a diplomatic reply to a suggestive inquiry made by the trust, but in no way an official stance on homeopathy that the BfArM would put into a press release of their own. If the BfArM were really concerned about potential dangers to the public, they most likely would have done a press release on 10:23 themselves. So Ali asked the BfArM.

Ali was interested in three questions:

• What was the context in which the BfArM quote was made?
• Is the BfArM really formally investigating 10:23 as an unregistered clinical trial?
• Why does a clinical trial have to be registered, if the drug it concerns does not have to be clinically trialled to get approval?

The final question basically concerns the ridiculous situation I mentioned earlier, that is that under European legislation, homeopathic remedies don’t need to prove their efficacy to be approved as drugs. This is a clear double standard. If they are drugs, they should need to prove their efficacy under Drug laws as any other drug. If they are not drugs but food supplements or similar, they need to conform to food laws, which, again, for claims of health benefits, require proof of efficacy.

Here is what the BfArM said:

• BfArM’s press office has only replied to questions by journalists and the Trust, with the very same reply. The BfArM itself has not actively issued a warning, and Ali’s impression was that they were not interested in homeopathy or 10:23 in particular.
• BfArM needs specific information on any clinical trial, official or alleged, i.e. the drugs used, participants, exact methodology, etc. Without such information they cannot judge whether something constitutes a clinical trial or not. Since they don’t have this information and don’t see means to get them (as, for example, the press reports lack enough detail on those matters), they are simply not able to investigate. 
So, there is no investigation. They continue to say that if there were real interest (which they don’t see, not even from the homeopaths) *and* more information, sure, they would look into this. What they say without saying: “Forget it, we are not concerned, no one really cares, so why should we bother?”
• On the hypothetical question about clinical trials on homeopathy, the BfArM remained diplomatic. They basically said to Ali that only because it is homeopathy there could still be concerns from a clinical trial – maybe they meant homeopathic remedies with a stronger solution that could still have active ingredients. Fair enough.

So, a storm in a teacup, as to be expected.

This leaves?

• One badly written article on 10:23
• A completely misguided press information by a homeopathic lobbying organisation
• Some shaken heads at the BfArM – with no further action taken

Will the Karl and Veronica Carstens Trust update their information, now that it is clear that the BfArM won’t do anything? Or even push the BfArM to investigate further? Very doubtful. As always, they are content with having a cherry-picked quote that – in reality – has no impact whatsoever.

For once, my trust in the the German Drugs Administration has been elevated a little bit. But it is still a long way to put homeopathy where it really belongs, both in Germany and elsewhere.

This is a slightly edited transcript of a contribution I made to Pod Delusion 73. The 10:23 campaign to raise awareness of the quackery that homeopathy is went really international this year. In 2010 I had spearheaded the local event in Leicester. It seems my “crisp Teutonic accent” came across quite strongly in our YouTube video back then. At least this is what one of the commenters wrote. He essentially invoked Godwin’s law by comparing me to my infamous German ancestors and their “failed attempt to take over Britain and tell us what to do”. Only when he wrote “we won’t let you besmirch one of the best British medical traditions”, I couldn’t help myself replying “I am sorry to say this, but this quackery is actually German...”. Germany is a big market for homeopathy and alternative medicine as a whole, and some of the large manufacturers are also based here. Homeopathy has recently come under scrutiny in the national press, with front-cover features in respected weeklies like SPIEGEL and STERN, or newspapers like Süddeutsche Zeitung or ZEIT. However, the German homeopathy lobby is strong, and I wouldn’t be too surprised if the ridiculous exception of homeopathy from European drug licencing rules was partly due to German intervention as well. But I will come back to that. I spent the 10:23 weekend at QEDcon in Manchester and took part in the overdose there, but tried to keep up to date with any news on the German groups, especially in Cologne and Essen, which both are close to where I live. One of the very first news articles I found was from the Kölner Stadtanzeiger, Cologne’s largest local newspaper. The coverage was appalling. The headline reads “A show by globuli critics”. At least they mention that the event is a rather “satirical” one, and they explain the meaning of the 10:23 name, Avogadro’s constant and hence that “there is likely nothing of the original substance left in homeopathic remedies”. However, the overall tone of the article suggests that the skeptics are a small group of paranoid show-offs who are up to something potentially dangerous. They quote the “BfArM” - Germany’s Federal Institute for Drugs and Medical Devices, which oversees drug licencing. BfArM says they generally “ask patients to use drugs responsibly” and that “calls to overdose on drugs are not helpful for raising awareness”. The article then goes on to quote the “Karl and Veronica Carstens Trust”, an alternative medicine lobbying organisation. The trust suggests that the call to overdose on homeopathic remedies could actually constitute an unregistered clinical trial under German legislation, even if a very badly designed one. They immediately bring up the usual claims why such an action does not prove anything anyway, that homeopathy does not work on healthy people, that it requires individual testing, and so on. In a nutshell, “according to scientific criteria, 10:23 does not prove anything, and therefore does not help public information either”. And they finish with stating that the sentiment that scientific research would only yield negative results for homeopathy, is false. Period. Brilliant. An article that (a) misrepresents what 10:23 is about, (b) only gives the side of a homeopathic lobbying organisation, and (c) seems to have been written without talking to either the organisers or any further research in the matter. Anyway, what immediately intrigued me was the comment of the BfArM, and the notion that - under German legislation on clinical trials - 10:23 campaigners could be in trouble. This sounds ridiculous to anyone who actually knows what 10:23 is about, but we have seen worse when administrative bodies decide to rather regulate the scientists than the quacks. With a quick Google search, you can discover that the quotes of the BfArM actually come directly from a press information published by said Karl and Veronica Carstens Trust. This suggests that Irene Meichsner, the journalist, more or less copied this press information, instead of contacting the BfArM herself for comments. The press information states that homeopathic remedies are subject to German Drug Laws, and that the BfArM actually investigates whether 10:23 constitutes a clinical trial that requires prior registration, which could lead to further actions to ensure the safety of patients.” I will spare you the rest of the press information, which is just an extended version of “this is why 10:23 is not feasible to properly test homeopathy” and “homeopathy works, here is our own list of positive studies”. So, the BfArM investigates 10:23? This is worse than I thought. Has anyone followed up on this? Oh yes - Ali Arbia of the zoon politikon blog at ScienceBlogs Germany. Based on the vague and quite general BfArM quote, Ali quickly assumed that this is just a diplomatic reply to a suggestive inquiry made by the trust, but in no way an official stance on homeopathy that the BfArM would put into a press release of their own. If the BfArM were really concerned about potential dangers to the public, they most likely would have done a press release on 10:23 themselves. So Ali asked the BfArM. Ali was interested in three questions: What was the context in which the BfArM quote was made? Is the BfArM really formally investigating 10:23 as an unregistered clinical trial? Why does a clinical trial have to be registered, if the drug it concerns does not have to be clinically trialled to get approval? The final question basically concerns the ridiculous situation I mentioned earlier, that is that under European legislation, homeopathic remedies don’t need to prove their efficacy to be approved as drugs. This is a clear double standard. If they are drugs, they should need to prove their efficacy under Drug laws as any other drug. If they are not drugs but food supplements or similar, they need to conform to food laws, which, again, for claims of health benefits, require proof of efficacy. Here is what the BfArM said: BfArM’s press office has only replied to questions by journalists and the Trust, with the very same reply. The BfArM itself has not actively issued a warning, and Ali’s impression was that they were not interested in homeopathy or 10:23 in particular. BfArM needs specific information on any clinical trial, official or alleged, i.e. the drugs used, participants, exact methodology, etc. Without such information they cannot judge whether something constitutes a clinical trial or not. Since they don’t have this information and don’t see means to get them (as, for example, the press reports lack enough detail on those matters), they are simply not able to investigate. 
So, there is no investigation. They continue to say that if there were real interest (which they don’t see, not even from the homeopaths) *and* more information, sure, they would look into this. What they say without saying: “Forget it, we are not concerned, no one really cares, so why should we bother?” On the hypothetical question about clinical trials on homeopathy, the BfArM remained diplomatic. They basically said to Ali that only because it is homeopathy there could still be concerns from a clinical trial - maybe they meant homeopathic remedies with a stronger solution that could still have active ingredients. Fair enough. So, a storm in a teacup, as to be expected. This leaves? One badly written article on 10:23 A completely misguided press information by a homeopathic lobbying organisation Some shaken heads at the BfArM - with no further action taken Will the Karl and Veronica Carstens Trust update their information, now that it is clear that the BfArM won’t do anything? Or even push the BfArM to investigate further? Very doubtful. As always, they are content with having a cherry-picked quote that - in reality - has no impact whatsoever. For once, my trust in the the German Drugs Administration has been elevated a little bit. But it is still a long way to put homeopathy where it really belongs, both in Germany and elsewhere.