Friday, 23 December 2011

Has the journal Nature sold out to the alternative medicine industry and quack/fake science?

What to say about this move of the world's (by far) most prestigeous scientific journal?

 Well, this surely does not inspire much confidence:

We are grateful for the support of our sponsors, Saishunkan Pharmaceutical Co., ltd. and the Kitasato University Oriental Medicine Research Center.
And I'm sure the boost of the Nature bank balance was handsome. This suplementary issue will very probably also do wonders for the Nature impact factor, a commodity worth its weight in rhodium in these days when scientific publication and citation is a currency and – if stunts like this are becoming a habit among the leading journals – pretty soon not very much more than that. The Nature editors must be proud of being pioneers in this area.

One blogger with both insight and clout has so far concluded:

I'm left with the conclusion that, to their eternal shame, by publishing this issue, the editors of Nature have become willing shills for the TCM industry. Nature has sold out, and its editors and publisher should be called out for it.

But, please, judge for yourselves here (the supplement issue is apparently open access online) and read the comments so far....

Here, and here.


Tuesday, 20 December 2011

Merry X and a Happy Y from Philosophical Comment!

We are approaching (or perhaps in some cases already in) that period this time of year where various festivities originating in the phenomenon of winter on the northern hemisphere of the Earth and that of summer on the southern are taking place. Call it whatever you like, regardless if you want to install some sort of institutionalised religious connotations into it or nor not – for the purpose of this post I'll call it X. We are also quickly getting closer to a night that in many people's minds has a meaning over and above expressing the calendar convention invented in the 1500's. Nowadays mostly an excuse for adding to CO2 emissions in spectacular manner that is televised all over the globe, I'll call this phenomenon Y. As we are approaching X and Y, like last year, I thought that I should sum up how Philosophical Comment during has been doing in 2011 – if nothing else for the practical reason that after Y, my blog statistics will not tell me specifics for that year.

The overall trend is that the interest in Philosophical Comment is growing in a (for me) rather unexpected way. Here's a graph illustrating the number of readers since May 2009 to this day (December 20, 2011):

As I write this, the total number of readers is quickly approaching 40 000 (thirty-eight and a half thousand to be precise). The last 3 months have ended with over 4000 readers each and if nothing extraordinary takes place, this will be the result also of December.

Looking at the posts from this year, the charts in terms of number of readers looks like this:

For some reason that is beyond me, a post in a series reporting about a partly inside, partly official quarrel related to a leading research journal in my field, The American Journal of Bioethics, has continued to attract readers in spite of being a matter of the past and is the top 2011 post by far. The reason for why the second place is occupied by my piece on publication ethical problems within bioethics is far more understandable, not least since it spurred quite a lot of debate involving, among others two chief editors of bioethics/medical ethics journals. It is an even smaller surprise to find my take on the decision to declare Norwegian extreme right terrorist and mass murderer Anders Behring Breivik legally unaccountable attracting readers – the post has also been linked to by several bloggers in Norway and other Nordic countries. After these comes a number of posts that have attracted well over 500 readers each, among which I am particularly happy to find a very recent one (thus promising more) on where activists who have been targeting the quack scam cancer clinic run by a Stanislaw Burzynski should be directing their attention to put a halt to this sorry excuse for medical practice. I'm also pleased that one of the posts on the very controversial and heavily criticised claim of Priscilla Coleman that abortion can be shown to cause mental health problems (as it seems, solidly rebutted by a recent huge study, if not before) made the top list.

It is difficult to extract more precisely what sort of people from what places are reading Philosophical Comment,  but one trend this year is clear; Russia and Germany are picking up behind USA, Sweden and the UK. Now, if I look at statistics for particular weeks or months, odd countries of all sorts may pop up, but the just mentioned are the clear top sources of readers. So, in all, the readership continues to be quite global, although some countries from the northern hemisphere are dominating as the home of readers:

And here's a list to underscore the trends:

So, that leaves me nothing more than to thank you all who read, link, pass on, quote, comment and so on. See you next year, here or on twitter. Merry X and a happy Y!

Saturday, 17 December 2011

Time for Pressure on Media Promoting and FDA Facilitating the Burzynski Clinic Quack-Scam

The criticism of the close to fraudulent cancer treatment scam operated by the Burzynski Clinic that I have covered in some earlier posts (here, here), due to its attempt to silence public criticism through legal threats and general bullying and harassment, needs to shift focus. We know that what the clinic does is a confidence scam of a classic type: The necessary confidence-part is secured by conveying an impression of offering a "last hope" experimental treatment to desperate cancer patients and their close ones (while what one is actually offering is a procedure that has been experimental for three decades and not been shown to have any sort of effect in spite of all these years of research devoted to that end). The actual scam is the appallingly high price charged for the FDA-approved chemotherapy treatment that has to accompany the experimental one, lest the clinic would be clearly guilty of severe malpractice. But, as I said, this is now well-known and need not be further supported, besides mentioning some additional details that have surfaced lately, such as the disastrous track-record of the Burzynski clinic's clinical trials and the piquant fact that those who want to make donations to support the clinic's research are asked to wire the money directly not to the clinic or its attached research center, but to the dear Dr. Burzynski himself, and the fact that said Dr. Burzynski is under investigation for rather serious misconduct by the Texas Medical Board.

But let's not once again lose ourselves in what we already know, but ask the question: what makes the scam possible? One, of course, is the combination of the quite understandable desperation of anyone who has been struck by the information that one or one of one's close ones has incurable, terminal cancer – this is the source of there being a prey for the Burzynski vulture-strategy. Second, equally obvious, the complete  ruthlessness of the clinic itself and , at least, its leadership and its medical and management staff. But the fact is that that the clinic is extended ample help and support from two directions that are not equally obvious or expected.

One of these is "old" mass media. What started the whole story this round was an article in the UK newspaper The Observer, promoting a charity call for financial support of a family that wanted to take their sick child into the Burzynski program, but couldn't afford it (no wonder!). It was blog posts (primarily this one and this one) reacting to the fact that an otherwise respectable newspaper in this way made itself into a mindless megaphone of a quack-scam that attracted the wrath of the Burzynski Clinic, eventually leading to the ensuing threats and harassment. Later, it has been discovered, that the very BBC choose to publish a more or less similar item. Quite recently, The Evening Standard (also the UK) made a rather similar publication, wording its article carefully to make the facts about the Burzynski treatment look dubious and inconsequential by placing the word 'unproven' last in the article and surrounding it with square quote-marks (thus implicitly conveying the message: 'that's the establishment using fancy words to hide the fact that they don't care about seriously ill children'). Representatives of all publishers have defended the publication of their articles (here, here and here), but seem not to understand what they have been doing – which is making themselves into marketing tools of the confidence scam of the Burzynski Clinic for the prospect of attracting a few more readers. They all refer to a "human interest" reason for publication, but this falls apart as soon as one sees through the shallow, shiny coating that makes the Burzynski Clinic remind of a respectable health care institution at first glance. This is simply bad news-evaluation, poor research and bad publication judgement. Unless, of course, there are deals under the table that would at least make the publication make short-sighted financial sense. In either case, I fully concur with Josephine Jones' conclusion that the publications are immoral.

The other source of support comes from the U.S. Food and Drug Administration, FDA. This was a theme of the criticism that was pursued by Oxford University neurolopsychology professor and popular author Dorothy Bishop early on and which I mentioned in my first post on Burzynski. With all the threats and harassment against bloggers, however, it sadly disappeared as a major theme in the discussion. For, this is a fact: one thing that makes the Burzynski Clinic scam possible to run within the limits of the law is the fact that FDA has been continuously granting the clinic permission to run clinical trials for several decades. This despite the set-up of the scam operation, where these trials are systematically exploited to press enormous amounts of money off of desperate and vulnerable people. There are three very good reasons for why this should make the FDA retract all trial permissions. 

First, one may plausibly argue that what the Burzynski Clinic does is to use the hugely elevated charge for regular chemotherapy to cover the costs of the clinical trials, which means that what people are in fact paying for is to be allowed to participate in experiments with unproven procedures. But this goes against all minimally decent research ethical standards. When a patient participates in a clinical trial, it is the the patient who is doing the clinic running the trial a service, not the other way around. If anyone should be payed anything, it is the patient who should receive and the clinic that should give.

Second, the confidence scam is by itself reason enough to withdraw permissions. Someone may try to argue that, for a private health care institution, it is not wrong or unreasonable to cover costs of research by distributing them in the form of a price increase on offered services (that's a bit like viewing research as a part of the overhead). However, in the case of the Burzynski Clinic, this argument is unavailable for two reasons. One, the clinic offers but two services: regular chemotherapy on its own, or chemotherapy plus the experimental procedure, and it is the price of the latter that is elevated. Two, the clinic's marketing shows that in reality the research and the regular clinical practice cannot be separated. The Burzynski Clinic has but one service on offer: regular and approved chemotherapy with add-on of an experimental procedure. From whatever side one looks, this is a clinical trial, and that is what the clinic charges for.

Third, the track-record of both the past research of the clinic and the scientific publication of Dr. Burzynski himself is, in combination, a rather serious reason for doubting both the scientific basis for viewing the research as defensible in the first place, and the competence of the Burzynski Clinic team to conduct it. Add to this the investigation of the Texas medical Board mentioned above, and you can add reason to doubt the scientific, medical and ethical integrity of the research leader.

If the FDA was to decide to review the entirety of this complex of reasons, I'm quite sure that they would indeed find cause to revoke the permissions for conducting clinical trials granted to the Burzynski Clinic. And if not that, so at least reasons for changing some of its regulation so that a decision to revoke could indeed be supported. In effect, there are very good reasons to pressure the FDA on this point. Not being a US citizen, I myself do not feel well placed to figure out the best strategy for doing that in an effective manner (petitions? open letters? formal complaints?....), but if someone better placed takes an initiative, I would be more than happy to get on the wagon!

Sunday, 11 December 2011

COP-17: Brazil, China, India, South Africa and USA Wearing the Dunce Cap, Europe the Jester's

Some of you may know that this has happened to become a bit of yearly feature – me commenting on the latest climate policy debacle happening as clockwork this time of year. Earlier posts are here and here. Sources for getting to know about the outcome of this year's COP are here, here, here, here, here, here (last three international, more below).

To summarise, the outcome of COP-15 in Copenhagen in 2009 was nothing except that everyone agreed to keep meeting and that having a climate change policy deal capable of stopping the increase of the global mean temperature at 2°C is an important target. In Cancún last year (COP-16), not even that happened, since Bolivia declined to sign on to continued talks. What did happen, though, was a sort of thing that ended up as the main product of this year's talks, namely agreement not on any policy, but on the practical structure of continued talks. In the COP-16 deal, this agreement was restricted to the way of handling the most difficult questions of all, namely the distribution of the costs of climate change policy (emission reductions as well as adaption to inevitable natural changes); which is planned to be dealt with through a special fund.

This year, nothing more about this fund was said (such as how it is going to become filled with money), but a similar empty institutional form has been set up for the entirety of the continued process, planned to lead to an agreement on emission reductions in 3 years. In short, instead of yearly meetings at the highest levels, there will be a committee that will work for almost 3 years to tailor an agreement and a new COP-meeting in 2015 where, hopefully, the committee can present a substantial deal about climate policy rather than meeting policy that all countries are willing to sign on to. This is the "roadmap" that is presented as the success of COP-17 in Durban.

As, usual, if the expert commentators are to be believed, this agreement, is full of ambiguities, grey areas and explicit holes, but that goes with the territory of international agreements. However, what it effectively does is to reduce the number of opportunities for the global community to actually agree on something with any chance of reaching the goal of no more than 2°C increase of the global mean temperature from three to one. After 2015, experts advise us that we will have to start calculating with more drastic average global temperature increases even if very effective policies for reducing greenhouse gas emissions are eventually put into motion. Now, the 2° target, it must be understood, is not in any way magical or set in stone. In fact, some claims it to be a much too allowing goal. Moreover, the target is rather a range than an exact temperature, since the climate models necessarily embody rather drastic uncertainties. But the 2°C is of importance for two reasons. First, it is one of the very few substantial things about climate policy that the global community has been able to agree on. Second, it approximates the limit of our empirical knowledge from the past and, thus, our basis for prediction, preparation and adaption in face of the various changes that increases of the global mean temperature bring. A bit simplified, beyond 2°C, what we have is basically mathematics and fantasy – something that is amply illustrated by the predictive models in climate change research. Our ability to prepare for whatever will be coming – and thus to be capable of reversing the process without considerable higher cost to human life and well-being – becomes drastically weakened. So, seen in this light, the bare bones of COP-17 is that such a prospect has become 66% more likely by agreeing on one attempt to agree rather than three.

Now, if any politically minded person reads this, he or she will probably protest. The reasoning above ignores that the model of yearly meetings at the highest level has a solid record of failure, and that the Durban roadmap means that a committee will be working for three years before the next meeting. This is a big different to the situation where initiatives were left to individual countries or leagues of such. They will say: the basic problems – the unwillingness of high emission countries to commit to the needed reductions and the unwillingness of rich countries to face the fact that if they do not pay for the needed measures, no one will – necessitates that whatever proposal is presented at the next meeting is well worked out in the eyes of all sides and parties. I accept this logic of the pragmatics of politics, but I am skeptical about the conclusion. In fact, when not having the spotlights of the world stage on them, isn't it even more likely that high emission countries will continue to press even more heavily the rest for more concessions and rich countries do the same to less rich ones? Then, when the result is on the table,  all that will remain is the window-dressing that makes it look OK in the eyes of the public, while under the shiny surface mostly expressing short-term and, in this context, petty national interests. In short, committee, fine – but let's speed up and have one working while keeping on having at least one high-level meeting every year to ensure public and critical scrutiny the whole way!

Looking at things from that angle, however, implies a standpoint that fit most politicians pretty bad. It means, for example, acknowledging that this year's COP meeting, just as the former ones, was a massive failure. Not, as this commentary from UK Energy Secretary Chris Huhne tries to spin, a series of successes. Why is this so repugnant to a politician? Well, basically, because of two things. First, in the current situation, where the unholy CO2 emission alliance of Brazil, China, India, South Africa and the USA, are allowed to keep bullying the rest of the world, everything that is an avoidance of total disaster is possible to hold out as success. This is what the statements of Secretary Huhne and a whole band of European politicians are illustrating today. The presence of the climate policy boogeyman (i.e. above mentioned countries) is used to make oneself appear as a hero when, in fact, what has occurred is that one has let oneself be pressed one more notch in the shortsighted game of chicken played by these countries. In this game, apparently, Europe and the rest of the Kyoto-protocol signing countries are allowing themselves to become what game theorists know as money pumps – someone who is applying a strategy that makes one systematically vulnerable to making deals that sum up to a loosing position, while one's counterpart is systematically winning, although each singular deal may look like a winner. Giving in to blackmail (which is, effectively, what Europe is doing in the climate policy negotiation game) is a prime example.

On a larger scale, what is achieved by the Eurpean (plus Canada and Japan) strategy is the following: Brazil, China, India, South Africa and the USA can go hone from Durban, as they could from Copenhagen and Cancún, telling their people that all is well and that they needn't worry. They don't have to tell them that they need to change their expectations to future material growth, the price of energy or anything like that. Why not? Because they have ample evidence that they can press other countries to pay all those bills the day when they arrive. In effect, we may expect no, repeat no, preparation on the political home-fronts of these countries for a climate deal in 2015 which implies making actual concessions and taking on actual commitments. This, I claim, is the main result of the strategy of the EU and the rest of the world in Durban. So ask yourself, how likely does a substantial climate policy deal in 2015 look in that light?

Good work, Europe!

Friday, 9 December 2011

Videos from The Philosophy of Hate Crime Symposium.

As some of you may recall, in a post earlier this fall, I shared videos from a symposium arranged by a project I'm working in on the basis for European hate crime policy, and informed about a 2nd symposium on philosophical issues actualised in that context that we arranged here in Gothenburg. Even earlier I have made a few posts on issues actualised by the project (on the relation between hate crimes and human rights and on the role of prevention in a sound hate crime policy) and pointed to many more at the blog of my colleague David Brax.

We are now happy to be able to share videos of almost all of the presentations and attached discussions that took place during the Philosophy of Hate Crime Symposium, arranged by David and me at the University of Gothenburg a few months ago. As I myself fell ill on the 2nd day, you will only see me appear in the introduction, but David does a splendid job of holding together by himself what was originally our shared presentation on such short notice in the last video below.

One of the more nice things that I noticed when watching this footage right through was how surprisingly well it captures the atmosphere and spirit at what was a bona fide research workshop, rather than a public engagement event put together for that particular purpose. What you see is an example of what goes on in the laboratory of a research unit in the humanities and social sciences, basically. Welcome to take a peak!

1. Anthony Mark Cutter & Christian Munthe: Introduction to When Law and Hate Collide

2. Paul Iganski: How Hate Hurts: The Moral Philosophical Basis of Hate Crime Laws 

3. Barbara Perry: Moving Beyond "Hate" Crime 

4. Neil Chakraborti: Targetting Vulnerability - A Fresh Set of Challanges for Hate Crime Scholarship 

5. Heidi Hurd: Criminalizing Hate, Criminalizing Character

6. Mohamad Al Hakim: Hate as an Aggravating Factor in Sentencing 

7. Antti Kauppinen: Two Kinds of Expressive Harm 

8. David Brax: A Tentative Philosphical Framework for Hate Crime Policy Across the European Union

Wednesday, 30 November 2011

Lame Response from the Burzynski Clinic

Yesterday, the Burzynski Clinic issued a press release in response to the massive twitter (1, 2) blog and eventually old media coverage of how an alleged representative of the clinic bullied and threatened bloggers exposing the highly unethical practices of the clinic (see my former post). What the clinic does is to charge huge sums of money for people to access what is described on the clinic's website as "tomorrow's cancer treatment today" (duh!), which basically consists of state of the art treatment of chemo-/radiation-therapy (available at much cheaper cost at other clinics) plus Dr. Burzynski's own little discovery, antineoplaston, that has remained in the phase II of clinical trial, where the aim is to demonstrate any sort of benign effect, for several decades with zero results. One very limited version of the treatment (for Brainstem Glioma, a very malign and inoperable form of cancer) has been approved by the FDA for studies in phase III, going beyond this limit – planned to start this year according to the clinic's website. This approval has been issued under a special so-called orphan drug statute, meaning that the FDA considers there to be an extra important reason to allow research due to the rareness and severity of the disease combined with the fact that there is no existing very efficient treatment. There are no details on the arms of the trial, but one may assume that since there is some efficiency of chemo- and radiotherapy also regarding Gliomas, the setup will be such therapies by themselves compared to the same plus Burzynski's own invention. Any other arrangement would be a scandal.

In any case, the deeply unethical and very close to fraudulent practice of conveying to devastated people hit by the tragic information that they or one of their loved ones suffer from incurable cancer that they can access some sort of miracle cure if only they empty their savings accounts in the greedy lap of the Burzynski Clinic has to stop. It is highly problematic already in a phase II trial, but it is completely unacceptable and against all research ethical standards in a phase III trial. In fact, if anyone should be paying anyone anything it is the Burzynski clinic that should pay trial participants for their service to lend out their already heavily burdened bodies and minds to help investigate a procedure that as yet has shown no clinical effect whatsoever. And if FDA regulation allows such practice in phase III, it has to change, effected immediately, since it is a loophole for manipulating and conning seriously ill and very vulnerable people.

Of course, as always in science, caution should be exercised in predicting results of forthcoming studies. Basically, we'll see what the phase III trial eventually shows. But if this summary of the history of research on Dr. Burzynski's research is to be believed, there is not much cause for optimism. But, hey, I haven't said anything about the press release yet, so let's go there.

The most important message of the press release is that the clinic clearly distances itself from the content of the messages sent to bloggers by Marc Stephens and stating that said Stephens is not a representative of the clinic, but....:

So, Stephens was indeed hired by the clinic to do the job that he did, he just did it so bad it is even fascinating. To see this, we go to the next stage of the message when the clinic starts to address how it will now proceed in relation to said bloggers with regard to said dissemination of allegedly false information:

Of these, points A and B are inconsequential for the matter at hand (although it may be noted that point A is a lie, search for ANTINEOPLASTON A 10 here and see for yourself). They don't affect at all to what extent the Burzynski clinic is manipulating vulnerable people to pay out hundreds of thousands of US dollars for a treatment they could have received much cheaper elsewhere and with an add on with no proven effect. Tastelessly enough, in the press release is included a report on how a single, named patient who is in one of these phase II trials is doing. I will not name her, and I find it rather inappropriate of the clinic to do so. In any case, the statement that she is improving because of Dr. Burzynski's antineoplaston treatment lacks all foundation, since antineoplaston has not yet been demonstrated to have any effect. The patient's promising form is thus most probably the effect of the radio-/chemo-therapy administered in addition to the antineoplaston addition. In any case, a phase II trial cannot prove otherwise, no matter how many patients are included.

So, what about point C, then? This indeed is of some relevance, since scientific publication is the sign that a researcher has made progress in a way that is condoned by independent scientific specialists in the area. Well, after 2006, the list provided in the press release states 1-3 articles a year up to 2010 (when there is one). None for 2011, apparently. But anyway, that's pretty OK, isn't it? Well, actually not, according to this look into what sort of publications these are. In short, the publication record of Dr. Burzynski's research isn't worth zilch. Prior to 2007 it is either published in journals with no impact factor at all (meaning not even considered serious enough a scientific journal to be worthy a rank in terms of importance), or a ridiculously low one for a medical journal (meaning that virtually no one pays attention to what is published there). This, in turn, implies that stuff sent to these journals is stuff that no one of the more influential and better journals deems worthy of publication. It may be added, that if there had indeed been some result of a new cancer therapy, that would be material for the most high esteem journals in the world. In addition, these journals turn out to be either fronts for pseudo-science or the works of happy local amateurs.

From 2007, however, there are articles listed from the quite respectable  journal Neuro-Oncology. But..... wait a minute, I may just as well directly quote Jen McCreight, whose analysis I am using:

Burzynski has not published a single paper in this journal. Every single citation is an abstract from a presentation made at a conference. For those of you not in academia, we like to hold conferences where people can present their research and network. However, you’re allowed to present preliminary results that haven’t been published yet. Any scientist can submit abstracts in order to speak at conferences, and if that single paragraph sounds interesting, you get to give a talk. It’s pretty much impossible to judge how legitimate research is from an abstract (or presentation) alone, and some conferences are not competitive at all when it comes to who gets to speak – they have plenty of spaces to accept all presenters. Journals often act as archives for conferences they’re affiliated with, and will list those abstracts.
This means that none of Burzynski’s research from this journal has actually been peer-reviewed by the journal. The fact that he never actually published this data says a lot. Seriously – if you legitimately found something that helped cure cancer, prestigious journals would be tripping over themselves to have you publish in them. The fact that you can’t publish your research anywhere except in the occasional bottom-of-the-barrel shady journal means your research is terrible.
 McCreight in addition rounds off with the observation that there have been several attempts to replicate the promising results of antineoplaston reported by Burzynski, but all have failed.

So, there we are. After 2006-2007, Dr. Burzynski has made numerous presentations at scientific conferences reporting promising results, but no one seems to be able to replicate these. These presentations have indeed been abstracted in the journal Neuro Oncology. However, after some articles in scientifically completely insignificant journals, after 2007 there are no scientific articles reporting Dr. Burzynski's research in print.

In effect, due to the list of publications provided by the press release, the scientific standing of the Burzynski Clinic now actually looks even less impressive than before. In effect, the call for the clinic to immediately shut down its preposterous financial scam has been strengthened. And so has the case for FDA to urgently revise any regulation making such scams possible.