Fish in a barrel

This is a guest post from Ian (@teachingofsci), which I think is a calm demonstration of why so many who try to engage with proponents of alt med end up seriously lacking a feeling of calm.

I have had similar situations in which I’ve tried to converse with otherwise intelligent, rational, friendly people, who have shouted that they will not read anything I ask them to read before we can continue the conversation with a bit more information behind us. If people are unwilling even to look at evidence that might not support their view, what’s the point, really?

Different people have different ways of going about skeptical activism, and advocating rational thinking – often with an ultimate goal of protecting gullible and vulnerable people from those who would profit from their ignorance, and perhaps simultaneously endanger their health. I don’t believe there’s a right way, but sometimes this kind of tactic can prove useful. Enjoy!

Following the BBC exposé showing that some companies and pharmacies are still selling homeopathic ‘remedies’ as if they worked as vaccines for serious illnesses (summarised at the Nightingale Collaboration), I saw some retweeted comments from @JessPinkus. Some of them were quite aggressive, and her stream included one directed to @drwollastonmp suggesting doctors recommend vaccines to make a profit. I found this quite ironic. She and many other fans of alternative medicine often raise the ethical issue of potentially damaging treatment for children. Medical professionals always consider this risk, which in most vaccines is vanishingly small. But she exaggerates this for real vaccines yet fails to apply the concept to homeopathy. It is legitimate to raise the side effects of vaccines, but only if compared to (a) vaccine benefits and (b) risks of (ineffective) homeopathy.

It’s reasonable to say that as the daughter of Tony Pinkus (of Ainsworth’s ‘Pharmacy’) she has probably been brought up with a fairly biased view of the usefulness of homeopathy, and feels she is defending her family. She pointed out that even though unvaccinated she has not suffered from pertussis, failing to recognise the protection she is offered by everyone else’s herd immunity. I’d like to place on the record that I am sure she is sincere.

That doesn’t mean she’s right.

After swapping a few tweets, I invited her to send me pro-homeopathy info, which I would read and comment on. In exchange I suggested she read and comment on Ben Goldacre’s 2009 piece in the Guardian. I would then blog about both sources and responses. She agreed and I shortly received an email with her comments and three documents as pdfs.

She then tweeted that she didn’t want me blogging it, didn’t want me to include her email and didn’t want her name mentioned.

Well, perhaps she misunderstood and thought I meant her email address, which obviously I would never share. But just in case she meant the text as well – despite agreeing to the original proposal – I shall summarise her response rather than quote it.

Comments on “Against” Evidence

I should emphasize that my correspondent did not actually engage with any of the ideas in the article. She wrote that she hadn’t read it properly, because she had read loads of similar things before. Instead her email made several points, which I have paraphrased.

  • Medical companies have a vested interest in keeping people ill to sell more drugs.
  • Homeopathy cures people and their symptoms disappear (correlation not causation, regression to the mean).
  • Drugs companies fund groups including the BBC (my emphasis) to criticise homeopathy (conspiracy theory).
  • Homeopathy is popular which proves it must work (appeal to popularity).
  • We can’t criticise homeopathy by asking for data, because that can’t contradict the experience of patients (anecdotal evidence).
  • Homeopathy is a choice and people should be allowed to make their own choice (she did not specify an informed choice).

I think the links sum up my thoughts quite clearly…

“For” Evidence

The three papers that were attached included a highly speculative model of how homeopathy might work, and a study looking at measured changes in EEG graphs when subjects were exposed to remedies. The last was effectively an advert from the Society of Homeopaths, but fails to make clear that their ‘meta-analyses’ only reference positive studies. They have still failed to produce evidence to contradict the 2005 Shang study, as Alan Henness has explained in the BMJ Rabid Responses.

Conclusion

I didn’t change her opinion. She didn’t even read the article I sent. I should have heeded the excellent advice implicit in the classic xkcd cartoon.

I did, however, get a fresh reminder about how so many people prefer anecdotes to evidence. It also encouraged me to look at this specific case with interest. While defending her father she linked to the letters published by the BBC. I feel these show very carefully chosen wording, perhaps designed to evade responsibility while still giving a clear recommendation for ineffective products. He presumably had this adjudication from the ASA in mind. (For other claims by Tony Pinkus you can see an article on homeopathy being used in Cuba.)

The real point I failed to get across is that the use of homeopathic medicines – even if the choice is truly informed, which is the last thing adherents want – really does have side effects. It limits effective medical care, and it affects society in the form of endangered children and adults. Despite appearing cheap, its failure to have any non-placebo effect means it is far less cost-effective than actual medicine. And if we allow homeopaths to use the language of ‘patient choice’ unchallenged they will continue taking advantage of the vulnerable.—

You can see Ian’s blogposts over on his site, here.

ALL the trials!

Be aware of this new and incredibly important campaign: alltrials.

It’s time all clinical trial results are reported. Patients, researchers, doctors and regulators everywhere in the world will benefit from publication of clinical trial results.

Please sign the petition

Please do. Doctors cannot prescribe the most suitable treatments, if they don’t know what the most suitable treatments are due to lacking information. Patients therefore suffer. Academics cannot plan their research effectively without knowing previous results. The government cannot make appropriate funding decisions without this information, either.

So, help to make ALL clinical trial data available to everyone who needs it – all of us.

Edit 05/02/13: GSK have just signed up! Amazing! Ben has written a quick post on it and here’s the alltrials news.

Here’s a bit about why alltrials is important, in the form of a write-up of Dr Ben Goldacre‘s talk in late 2012 for Soho Skeptics (albeit in a King’s lecture theatre near Waterloo…).

Bad Pharma

Obviously the title of Ben’s new book, which I’m sure he will be happy for you to buy!

So the main problems are: withheld trials; poorly designed trials and ignoring opportunities to run them; the failure to distribute results.

Evidence-based medicine (EBM) incorporates: fair tests; good analysis; spreading information. So, as it stands, a lot of non-evidence-based medicine seems to be going on, and not just from the usual quacks.

Drug development is a tricky business, and an extraordinarily expensive one. But sometimes a new drug gets through the early stages of testing to the point where we need to see what happens when it’s given to people. A famous example of how not to do this is now the trial at Northwick Park hospital (very near where I live now, incidentally) back in 2006.

Groups of patients are not given doses of experimental drugs in quick succession precisely for this reason. If the first has a severe reaction, quickly, you avoid causing it again! Apparently, several years before this a similar molecule was tested, but was abandoned. However, because the information wasn’t published, the warning was hidden. Although immunologists may find universal T-cell activation to be an… unwise pursuit regardless.

The European Medicines Agency (EMA) should have a registry of all European trials, but there are still several thousand missing. 14,000 phase 1 trials are hidden.

In the 80s, anti-arrhythmia drugs were prescribed for irregular heart rhythms following heart attack to prevent deaths. However, 130,000 people died before people noticed it was having the opposite effect.

The Cochrane Collaboration, with its “dead baby forest plotlogo (I think you had to be there, it was funny at the time), was established in the 1980s to comprehensively check results using databases of publications. This allows for systematic reviews and meta-analyses, and, forest plots! From these we can draw a conclusion based on all the evidence available on whether a treatment is effective, has no benefit, or is actively harmful. That allows us to make the best decisions, that is, based on all the information and not what might be a misleading subset of it.

Studies were also withheld regarding Edronax/reboxetine having no benefit or being worse than other available antidepressants. The German version of NICE (IQWiG) made Pfizer show all the data so that doctors could stop potentially harming patients by prescribing it. As a class of drug whose efficacy is constantly debated, a class I have tried myself (briefly and unsuccessfully) and a class many of my friends use, examples like these are particularly distressing.

The existing model that includes poorly designed trials also leads to the development of new, expensive drugs when older, cheap drugs work fine. Too many trials use the “last observation carried forward” method of recording data. So there’s the following scenario:

- people stop taking the drug as they found a lack of benefit or worse, intolerable side-effects

- in carrying forward their last observation of, say, level of pain – the benefit of the drug is massively overstated in the result.

It’s estimated that 50% of all trials are never published..! This can be described as research fraud, or at least misconduct. It is immoral and unethical. Yet no one seems to talk about it, none of the Royal Colleges have officially spoken out. Surely these kinds of groups should be spearheading this campaign?

What about the regulators? Well, they don’t get all the information either. They also have to make different kinds of decisions from doctors and patients. They still need all the data.

We need substandard treatment options. Some people cannot tolerate the gold standard, so they need alternatives. Regulators sometimes see black and white works/doesn’t work situations, and that’s not generally the case in medicine.

Now, the EMA rather than the MHRA approves UK medicines. Cochrane asked EMA for information on two weight loss drugs (Orlistat and one other) but they refused to provide it for 3 and a half years. They argued that it was “confidential information”, such as in the trial design (it wasn’t), that there was an administration burden involved (there wasn’t); patients were exploited for commercial gain. The EMA is now releasing more, but not enough.

£500m was spent on Tamiflu. £5 out of every £20 in the NHS’ drug budget. Roche are still holding some of the information on around half of the trials; they promised to produce it in December 2009 but we are still waiting for it.

GSK are similarly despicable and have had to cough up a $3bn fine (not a huge percentage of their profits, of course).

Apparently the abpi behave in a surprisingly similar way to homeopaths when they are criticised.

“Conflicts of interest are situations, not behaviours – judge people by their actions” – Ben

Is there a concerted campaign to change this? Not really, said Ben at the time – now there is! Patient groups need to write to Pharma companies. There’s a lack of leadership and poor reporting on the issue; MPs are ill-advised.

No one makes the challenge so people continue to deny the problem, because they can?

Questions

What can we do?

[Apart from signing the petition!] Doctors need to write to the Royal College(s)/BMA to complain about publication biases etc. – send any replies received over to Ben [and the campaign]. Patient groups should contact the relevant drug companies. Anyone can!

What about non-UK companies? … if a company is attacked on home ground, won’t they move?

Asked senior politicians about this. The abpi said prescriptions talks with the NHS drove down drug prices. The prospect of job losses is fine. What’s not fine is letting them withhold data “or jobs will go” – patients are harmed by this!

So what levers are there? NICE; they could not approve drugs until all data has been shared.

Can we at least get Europe to do this? Coalition pressure, Australia, New Zealand, Japan… The government can lobby colleagues coherently. No marketing without total results. Unknown results – how many deaths? New policies? Better decisions?

What’s a good response to alt-med fans and peddlers accusing of ‘conspiracy’?

It isn’t, it’s the inevitable behaviour of corporations running under incompetent regulatory frameworks. It’s rational. Imperfections – but people are stirring to improve EBM.

Quacks are thousands of times worse.

But if they can be allies, if they could help fix EBM problems..?

Quacks do provide interesting case studies and useful demonstrations of what EBM is because what they do is not.

Pharma companies do not respond to placebo, so we need to do something real. Antivax and quacks have poisoned the well here.

NB/ RandomiseMe should be up around April/May 2013. Random tests (not necessarily medical) to take part in.

PatientsLikeMe is useful for logging symptoms, side-effects etc.

Why isn’t the financial sector more concerned?

Generally it’s not a company value issue because consequences are miniscule (Tamiflu is still selling).

GSK fine didn’t affect their stocks, about 10% of their revenue?

Jan 2012 report showed 1/5 trials are put on clinicaltrials.gov, but no fines given.

Thus ends my patchy notes – finally, sign and share the petition!

Libel Reform update: 3 years on

Background

A couple of years back I attended a Skeptics in the Pub meeting in Holborn at which Dave Gorman and Prof Brian Cox came to support Simon Singh. He had been served a libel threat by the British Chiropractic Association (BCA) for criticising claims from chiropractors about curing colic in babies and so on. A dangerous claim to make, and, as Simon put it, a “bogus” one.

Fortunately, Simon won his case. Others haven’t been so lucky, and more threats are being issued.

There are many problems with the UK libel laws – lots of background information can be found here at libelreform.org and I’ve written some posts over the years (really rather a lot of posts actually), if you’re interested in past events.

Essentially libel laws are often used to silence fair, necessary and important criticism. People without the money to fight these hideously expensive cases tend to just give up. Individuals are bullied by large corporations, medical debates are stifled, unethical behaviour is hidden.

The libel reform campaign has been set up and run by the three charities, Sense About Science, English Pen and Index on Censorship. Two years ago there was the Big Libel Gig, to fundraise for victims of libel threats.

Libel Reform in Parliament

So today’s journey to the Houses of Parliament (committee room 11, in fact – compared to 14 two years back!) was to look at the current situation. A draft bill has gone through (and sorry, from the get-go, my legal/political terminology is likely to be incorrect at times – feel free to correct it!) and we’re looking at how it measures up to the promises given by all three parties before the last general election, to see if the proposed changes are what we need.

Me looking bored in orange – just concentrating, honest! (Photo from @mwstory)

In attendance today were Dara O’Briain, Brian Cox, Dave Gorman, Ben Goldacre, Jon Butterworth, Evan Harris, Peter Wilmshurst and many others, we packed out the committee room like last time. A summary from the Guardian here and Mike Harris writes, too.

Speakers

I’ll go through the speakers in the order they appeared with any comments/links I feel necessary! Here’s an awesome video summary from the day:

Kirsty Hughes - Index on Censorship chief exec.

Kirsty gave a quick introduction and mentioned the passing of the USA’s SPEECH Act, which prevented foreign libel suits from being enforced in the US – a measure to counteract libel tourism, which is a big problem with our own libel system.

Jo Glanville – Index on Censorship editor and incoming English PEN director

Jo mentioned that in the current bill, libel tourism and libel chills in peer review situations have been addressed, but the public interest defence has not, nor has the issue of corporations vs. individuals. Due process for online forums should also be considered (the lack of provision for the internet age is a common problem in our legal system – coincidentally the Twitter Joke Trial was ongoing as well today).

Robert Flello – Labour MP for Stoke-on-Trent

Robert asked how anyone can possibly interpret these laws and defend themselves, not being a lawyer himself and having tried to “get to grips with things”, while he has more resources available to him than perhaps the average person. He stressed that the libel threat letters sent to people are intimidating and bullying, and much work is still needed to improve the bill. It shouldn’t always have to involve the courts so the clarity must be there, in addition to sorting out the corporations issue. While government is in recess for the summer, lobbying must continue for all that time in order to add new clauses.

David Davis – Conservative MP for Haltemprice and Howden

David said we must “extend protection to anyone making well-informed, well-intentioned critical comments that are in the public interest”. Regarding the phenomenon of parliamentary privilege in the commons, he pointed out this kind of protection should also operate in science and medicine, where it’s vital we can have debates without fear of being silenced.

He asked rhetorically whether the parties have understood what is being asked of them, considering the complexity of the issue. The public interest defence aspect is still impenetrable and we don’t just want to rely on ministers being persuaded over the summer – coalitions respond to pressume fromt he back benches, so what is wanted and why must be made clear [I'd say it's pretty clear already, but hey].

We all need to be able to say when someone is/people are wrong and “behaving like charlatans”!

Simon Singh – funky-haired mathematician, author and TV bloke

It’s all been going for 3 years! Simon recalled the first meeting at SitP and that everyone in attendance agreed it was a disgrace that people could be silenced in this way. As a thought experiment, he asked if we passed the current bill and there was a new case… what then? Actually, nothing has really changed. It would still eat 2.5yrs of your life and cost you a hell of a lot of money.

So, we have to change it, including the public interest defence in particular. Clegg apparently said it should be an “international blueprint” and Lord McNally said “this will be my legacy”. But new cases are still happening, and the chill is still there. We have to make the politicians understand!

Dave Gorman – comedian, author and presenter

Dave has written his own post here. He started by asking us to look at Simon’s case from the BCA’s point of view. Were they lying when they made their claims? If not, then they should have welcomed the debate that ensued. They were given the right of reply to Simon’s Guardian article to explain their claims, they declined. They just wanted to silence their critics.

What about the thousands of cases that don’t get to court? People who can’t afford it and are scared into keeping quiet. What truths are we not hearing??

Dave Gorman speaking

Kamila Shamsie – novelist

Kamila wished to highlight that the arts also suffer libel chilling effects. Novels have been written and people have decided that characters resemble them closely, have sued, and the book disappears. Libel also affects our culture because of self-censorship. Publishers often can’t afford to spend money on laywers as well as new novelists. People are marginalised and shut out, and small publishers can be put out of business entirely.

Ben Goldacre - Doctor, author, massive nerd

Ben was sued by Matthias Rath, a vitamin pill salesman who tried (and sadly succeeded a lot) to convince people that taking his pills would cure them of HIV/AIDS. His case lasted 17 months, cost £535,000 and even though they won, only £365,000 of the costs were recouped, meaning that winning such a libel case still costs £175,000 (thankfully picked up by the Guardian) and a hell of a lot of your time.

Medicine is full of claims that are dangerous, people make mistakes trying to good, and sometimes charlatans step in deliberately misleading people. We must be able to criticise because people’s lives are at risk.

Ben ended with: “Do you want us to stand up and criticise these people, or do you want us to shut up?

Dara Ó Briain – comedian and presenter

He does a lot of talking on stage, taking the piss out of quacks and bad science and the like. Ben and Simon are quite well-versed in the background though, yet have still faced this problem – how is he supposed to feel! The chilling effect is far-reaching.

The Reynolds defence applies specifically to the media and journalists and as such doesn’t work for small groups/organisations or individuals, bloggers, etc. With respect to those who use libel threats to unjustly maintain misleading reputations and claims, “we cannot offer them the privilege of not having their feelings hurt“.

Dara speaking

Brian Cox - pretty physics prof., presenter, pianist (all the Ps! Wait, what?)

Here’s Brian summing up on BBC News. He kept it short yesterday, but emphasised that the scientific process is, unsurprisingly, really important in science! It has to be protected; if the laws aren’t reformed, people can’t work in the way they need in order to do their science.

Brian speaking

Katie O’Donovan - of mumsnet.com

The national importance of libel reform had been highlighted so far but Katie wanted to emphasise the public and personal need for freedom of speech protection. Protection for people discussing spurious claims made by people and companies about food, birth and so on – people need to digest these claims without the libel chill hanging over them and its potential threat to their livelihood. What is the value of anonymity online? A huge debate, it has its problems (trolls, bullying etc.), but it’s also vital in allowing people to talk freely, protecting themselves from potential dangers (think victims of violence) and obtain advice – the potential is there in the bill but it needs to be improved.

David Marshall - Which? consumer group

Evan started by pointing out that consumer organisations, such as Which?, sort through the vast number of claims made by companies trying to sell us things.

David highlighted two points of law (that I admit mostly went over my head), the first being the Reynolds defence as a public interest defence – possibly more? The second being that corporations are often using libel as reputation management. It’s a poor way to do business, just by silencing your potential critics!

Stuart Jones - biochemist, new libel victim

Stuart works for the NHS as a biochemist and just last week was threatened with a libel suit by Dr Sarah Myhill after raising concerns about her practice (details from Sense About Science, who are helping, along with some well-known “charitable lawyers”!) He wanted to speak about the feelings caused by receiving such a letter, after trying to do something important and good, realising that someone wishes to bankrupt you. He referred to the “months of legal wrangling” defending your comments, which makes you feel depressed, powerless and importantly puts you off doing the right thing in future. Ultimately, patients suffer. He ended by asking: “Who exactly are Britain’s libel laws currently protecting?

Kate Briscoe - www.legalbeagles.info

Legal Beagles is an OFT-approved free consumer legal advice service. They received a defamation libel threat from Schillings, a privacy law firm, regarding their clients Retail Loss Prevention Ltd. RLP carry out “civil recovery demands” following shoplifting allegations; intimidating and often disproportionate demands of recompense from the supposed perpetrators. This indiscriminately includes the mentally ill (e.g. people suffering from dementia who cannot be held fully responsible for their actions) and even parents who return items taken by their children without their knowledge.

There was a discussion about RLP in their forum, and it is hoped that the whole practice of civil recovery should dissolve soon. Schillings requested IPs and contact details be given of all posters, and that they all be banned from the forum (including the owners!!). Given that Legle Beagles have no assets or property and technically nothing to lose, they are admirably taking on this bullying company. After learning that Schillings are threatening other consumer services, including the Citizens’ Advice Bureau(!), Legal Beagles have published the letter in full. Amusing, given that Schillings say on their website, “Resolution: achieved out of the spotlight”!!

Kate ended with one of my favourite points: “You have to be super-rich or penniless to deal with such a threat“.

Lord McNally - Minister of State for Justice

He started by poking fun at Evan, saying he “not only invites you to speak, but tells you what to say as well!”. Ehem. He went on to thank the allies, Pen, INDEX and SAS, and pulled up Dara’s statement that we’re “no further forward”, but pointing out that we were “not in the pub”! And that it’s quite a long way to have come. 18 months ago the private members’ bill was drawn up, following pre-legislation it’s now in the Commons and will come back in Autumn then into the Lords’ around November. It was hoped that it would all be done before Leveson but sadly…

The “balance” on public interest may not be right, so that’s “to play for”, apparently. He reassured us that we are “mid-way through”, with support from all three major parties. He said, “even if you don’t get everything you want, libel is now being reformed before parliament” – I’m not sure how comforting that is! Amendments are often strengthened so it will be talked about again, and we shouldn’t be pessimistic.

The question of the internet is difficult, he is aware of the need ot protect freedom online, particularly considering the replication and privacy issues. [The problem of the government largely being made up of people who do not understand the way the internet works or truly wish to protect it is a debate for another time].

They are attempting, honestly, to improve the law. It isn’t a party political issue and it’s a chance to make a good piece of legislation. That is still his intention.

Peter Wilmshurst - consultant cardiologist

Peter recalled that NMT Medical, an American company that made experimental medical devices, brought three libel/slander claims against him. Over four years and £300,000 later, NMT went into liquidation and the ordeal appeared to come to an end at last. He wouldn’t have coped without getting his lawyer, Mark Lewis, on a conditional fee agreement (CFA). The National Research Ethics Service (NRES) found that Peter was not at fault with his comments about NMT’s devices (potentially dangerous to patients).

He was advised that counter-suing would probably be futile, costing upwards of a million pounds. They can’t recoup the costs from the American company now and, worryingly, between 2007-2011 patients have still received NMT devices. The legal action prevented any future discussion of the matter. As a result, patients have suffered heart erosion, replacement implants, perforations and emergency surgeries, and at least one death.

Lawyers have stated that if the current proposals were in force, it would make no difference to how this case played out.

Tim Appenzeller- chief editor, Nature magazine

Tim highlighted the chilling effect of libel on journalism. Nature not only publishes peer-reviewed research articles, but also opinion pieces and journalism, as well as daily publishing online. For every piece they have to waste time and resources on calculating the benefits and importance of the contents versus the risk if they publish. Too much never makes it to the public demain because of this.

Simon Hughes- LibDem MP for Bermondsey and Old Southwark

Simon agreed that the corporate sector can be very intimidating to individuals, and we need to support them and make sure defence is available. “Don’t go to sleep or disappear over the next few months!” was his advice to the libel reform campaigners.

Finally, we had some comments from Andy Slaughter (Labour MP for Hammersmith) and Tracey Brown (Sense About Science director, who said “the law might be complicated, but the issues are not… what kind of society do we want?

The session was closed by Paul Farrelly (Labour MP for Newcastle-Under-Lyme). We then trekked over to Downing Street where Dara, Brian, Dave and co. delivered the petition box to Number 10.

about to deliver the petition

I had a bit of a chat with people after that, then lunch with friends, and altogether it was a nice day. Encouraging but sometimes sad because people are still dealing with this, injustices are still happening. But we’re getting there – thanks to everyone who’s been involved in the Libel Reform Campaign! Keep it up!

Burzynski

I think it’s time for me to say something on this subject. It is after all very closely related to my current… vocation (if one can call it that, being a PhD student still!) and impacting directly on some of my friends.

One of those friends is my co-host of our long-neglected podcast, Super Duper Woo-Fighting Duo (With Capes)! – Rhys Morgan.

Edit: even BoingBoing is on it this evening!

Background

Feel free to scroll down to ‘The Threats‘ and ‘Some Interesting Correspondence‘ sections if you know all this…

The subject is one Stanislaw Burzynski, based in Houston, Texas. He offers an experimental treatment (though to call it that is probably a bit generous) to cancer patients called “Antineoplaston Therapy”. These antineoplastons are claimed to be peptides (bits of protein – though they’re generally not, technically – see comment 11 for more) found in urine. When a difference between cancer patients’ and healthy individuals’ urine peptide profile was found, an assumption was made that cancer sufferers were lacking these protein chunks and therefore replacing them should be an effective cure. A list of his patents and publications can be found here. This NYT article is extensive and demonstrates the shocking wealth accumulated:

… the gross income of Dr. Burzynski and an institute he runs was $40 million from 1988 to 1994… he took home $1 million a year.

However, the theory itself is dodgy at best and years of tests have not convinced the worldwide medical community. Yet Burzynski continues to run his clinic, charging people tens of thousands of dollars with promises of efficacy and hopes of being cured – even if the patients have been given a few months or years by doctors elsewhere.

Edit: this is shocking – records show Burzynski threw random chemotherapy cocktails at people (those saying chemo kills; well, he certainly didn’t seem to do his research on it), failed to disclose pharmacy ownership conflict of interest, did not alter treatment despite scans showing no improvement... Texas Medical Board might finally be doing their job.

Also see here for his public record – makes for a disturbing read. Plus, they also have a range of ‘healthcare products’, unsurprisingly – glorious website full of scibabble nonsense words and indeed typos.

What’s happening?

Now, more and more people are starting to criticise this man and his practice and the tactics we have seen so many times before – legal threats, bullying, hoping to silence – are coming thick and fast. There is now a petition asking the clinic to release a concise, publicly-available review of all the clinical trial data it has accumulated over the years.

The turning point was this uncritical article in the Observer about a stricken family with a little girl suffering from a serious brain cancer. The family details their emotional struggle – one which many of us will sympathise wholeheartedly with – and the resulting search for hope, their sights landing on Burzynski’s clinic.

Peter Kay offered to do some benefit gigs to help towards their $200,000 funds goal for this ‘treatment’. These were on the 24th and 25th November last week, and tonight the Comedy Store in Manchester is hosting another with various acts. I also saw a tweet reporting that BBC 6 Music had run an advert for one of the money-raising events.

Many immensely generous donations have been made. It is heartening to see human kindness at work – but so very upsetting given the circumstances.

Here are some e-mails regarding the article that were not published (or at least, not fully) by the Observer – a lot of people are concerned by their endorsement and the lack of provision to challenge what was written. Obviously this is a sensitive issue, around a grief-stricken family, but many others will continue to suffer if this is not properly addressed.

Publicity around this man and his dealings has soared today, as a result of retweets from Stephen Fry, Ben Goldacre, Dave Gorman, Dara O’Briain and continuing valuable support from others such as Simon Singh.

Another friend of mine, Kat, has written a fantastic post for the Cancer Research UK blog – this is serious stuff and those of us who have watched people deal with such a terminal illness do not want to see them swindled, spending their hard-earned savings lining fraudsters’ pockets and losing precious time with their families and loved ones.

Some people who have been directly affected have set up their own website in the hope that others won’t follow in their footsteps: http://www.burzynskiscam.com/

The threats

So, regarding the bullying I mentioned. Rhys wrote a post in mid-August detailing his views of Burzynski, backed up with accounts of past occurrences – including this case:

“Dr. Stanislaw R. Burzynski, had defrauded the plaintiff and violated the terms of the health plan.
We agree that the defendant may not trick the plaintiff into paying for an unlawful, unapproved drug. We AFFIRM.”

and how the 30+ years of trials have yielded very little to support the claims made. Check out Quackwatch from way back in 1998 for more.

He had to take the post down at the beginning of this month but he has now published all the correspondence here – please do have a read (also on Google+, and I’m pasting it below (click ‘read more’ if you’re on the blog homepage and can’t see it) because his site keeps going down!).

His silence was broken because Andy Lewis started receiving his own threats after he wrote his criticism of the Observer article, Kay’s unquestioning support and the issue as a whole. Another here for your amusement. Also read more from The 21st Floor, David Gorski, scienceblogs (good comments), Peter Harrison and Zen Buffy – Josephine Jones is compiling a kind of I Am Spartacus! list for posts on the subject.

Some interesting correspondence

A friend sent me this link to a September 2004 letter to the editor of the academic journal Integrative Cancer Therapies (who have published quite a few of Burzynski’s papers) from a researcher by the name of Andrew Vickers. He takes issue with an article by Burzynski published in the journal in March of that year:

Burzynski SR. The present state of antineoplaston research.
Integr Cancer Ther. 2004;3(1):47-58.

I’ve downloaded and saved this paper if anyone wants a copy, get in touch on Twitter or in the comments so I can e-mail you.

The article cites 73 papers and articles, 38 of which have Burzynski as first author, and a further 10 have his name as one of the first 3 authors – probably he’s in the list somewhere with the rest – plus a couple have one Burzynski B. (presumably a family member). If you search his name in PubMed, 45 articles are returned.

Moving on to Andrew’s letter regarding the paper cited above, it’s reasonably short – again if you want the PDF, get in touch, but I’ll paste it here with minimal commentary at intervals.

“Editor:

I read with interest Dr Burzynski’s recent review of research on his technique for treating cancer.1 I have several serious concerns about the scientific quality of his article. The first results presented by Burzynski concern glioma. It is claimed that 7% of 62 evaluable patients had a minor response. However, no fraction of 62 rounds to 7%: 4/62 is 6.45%, 8/62 is 8%*. There is also no fraction of 62 that rounds to 36%, the proportion given for objective response.”

So we can be fairly confident that he’s fiddling numbers from the get-go? * It has been pointed out that this is a mistake: 5/62 is 8%. Presume this is just a typo on Andrew’s part – the point remains.

“Burzynski goes on to report preliminary results of clinical trials on colon cancer conducted at the University of Kurume Medical School in Japan. He claims that the “survival rate of more than 5 years” on antineoplastons was 91% compared to 39% in the chemotherapy control group. Burzynski states that “the study was randomized and compared the results of treatment in 19 patients on . . . chemotherapeutics and antineoplastons [with] 56 patients who received . . . chemotherapy alone.” Yet the reference cited (reference 68) is to a case study. Moreover, a 91% survival rate for 19 patients is impossible, as it corresponds to 17.3 patients.”

 Again some weird numbers coming out, and reference to an article claimed to be about a trial, yet is in fact a study of one case.

“Burzynski also reports a single-arm study of 16 patients with liver cancer in which it is claimed that patients had longer recurrence-free intervals on antineoplastons than off. The citations supporting the claim include a case report and a lab study. Furthermore, the figure illustrating the results shows “time to recurrence [statistic not stated] in patients given antineoplaston AS2-1 after standard chemotherapy compared to control group.” This is despite there being no control group in the study.”

Again no reference to actual trials, but to a single case and lab-based work. Plus a lack of controls (so no valid comparison/conclusion can be made).

“There are several other serious shortcomings of the article. Survival data are presented in bar charts: the techniques for presentation of survival data (such as Kaplan Meier) are well established and were developed specially to deal with issues such as censored data; bar charts are unable to incorporate these features of survival data and are therefore considered inappropriate. No number presented in the text (eg, proportion surviving 5 years) is presented with a measure of uncertainty, such as a standard error or confidence intervals.”

 No reputable clinical study would discuss survival using bar charts. Kaplan-Meier curves have been standard for years. Also he’s presented no statistics for confidence in these numbers.

“I am aware that Burzynski is presenting preliminary data, and I have made no comment or criticism concerning the failure to present inference statistics. Nonetheless, even for a preliminary report, I see no excuse for the use of idiosyncratic and highly inappropriate techniques of presentation, failure to incorporate basic statistical estimates, citation of studies in support of statements when those studies have no bearing on the referring statements, inclusion of obvious mathematical errors, and citation of data for nonexistent control groups.”

He cites Burzynski’s study, to which he is referring, at the end of the letter.

Burzynski then wrote a reply! In the same month as Vickers’ letter was published (emphasis mine):

Reply to Vickers 

“Editor:

After reading Andrew Vickers’s letter, one may wonder  why the Assistant Attending Research Methodologist  of the prestigious Memorial Sloan-Kettering  Cancer Center would argue about 0.5% of minor  response and statistics that were not required, while  entirely missing the big picture: a proof of concept  and data on efficacy of antineoplastons in Food and  Drug Administration–supervised clinical trials involving  more than 200 patients. Vickers’s many arguments about unimportant issues obscure the realities of the data that we have presented, which indicate remarkable results in cancers for which chemotherapy and radiation are ineffective.

Publication of my article titled “The Present State of Antineoplaston Research (1)”1 occurred at the same time (March 2004) as the printing of Vickers’s article, “Alternative Cancer Cure: Unproven or Disproven?”  in the March 2004 issue of CA: A Cancer Journal  for Clinicians. In his review article in CA Cancer J Clin, he made reference to only 2 articles on antineoplastons published since 1987. He failed to cite more than 40 of our publications and approximately 300 publications by other authors on antineoplastons and their derivatives. In his letter to the editors, Vickers criticizes reporting of results of the clinical studies conducted at our clinic and also at the University of Kurume Medical School in Japan.  The criticism of our report concerns rounding out percentages to the nearest number. That is why we reported 36% of objective responses instead of 35.5% and 7% of minor responses instead of 6.5%. In the article, I also presented the actual number of patients, allowing readers to make their own calculation.

Vickers objects to my presentation of survival data in bar charts. This objection is unjustified in the context of my review. Kaplan-Meier survival probability estimates are more appropriate for detailed reports describing individual clinical trials. In my review, which describes numerous past clinical trials, there was not enough space for these estimates. Also, one should not compare apples and oranges. We can easily produce Kaplan-Meier diagrams for our studies, but, unfortunately, they were not published for comparison studies, such as Prados et al.2 If Vickers reads our recent articles describing survival in antineoplaston clinical trials, published in peer-reviewed journals between 1999 and 2003, he will indeed find Kaplan-  Meier data. Our data on the proportion of patients surviving 5 years contain no uncertainty, since they are  not estimated but true survivals. The patients are either dead or alive after 5 years. No standard error or confidence intervals are necessary.

The final reports on the studies conducted at the University of Kurume had not yet been published at the time my manuscript was submitted to Integrative Cancer Therapies. Japanese researchers have published preliminary reports and case reports; these were listed as references. The Kurume researchers presented the summary of research data directly to me with permission for publication. I described these as “preliminary results” on page 55 without making any changes.  Those researchers are now preparing the final reports for publication.

In conclusion, I believe I have sufficiently answered  Vickers’s questions regarding the clinical trials conducted  by our clinic. Further details will be provided in a number of articles that are now in preparation for  publication.”

Make of that what you will – no further correspondence noted.

I’ll just paste the acknowledgements from the paper in question here as these names may be of interest, and comment that the figures are generally of very poor quality, for a 2004 paper:

The studies were sponsored by the Burzynski Research Institute and supervised by its Institutional Review Board (IRB). The membership of the IRB was in agreement with the FDA. The authors [just Burzynski, for the record] express their appreciation to Lucy Rorke, MD, professor of pathology and neurology, University of Pennsylvania, Children’s Hospital of Philadelphia, for review of pathology slides; Dieter Schellinger, MD, professor of radiology, chief, section of neuro-radiology, Georgetown Hospital, Washington, DC; and Joshua Pleasure, MD, M. D. Anderson Cancer Center, Houston, Texas, for evaluation of MRI and PET scans.

The following physicians at the Burzynski Clinic (BC) participated in the study: Robert I. Lewy, Robert Weaver, Marc Bestak, Maxwell Axler, Alonzo Peters, Benjamin Saling, Barbara Burzynski, Tomasz Janicki, Jaroslaw Paszkowiak, Vishnu Alapati, Dmitri Davydov, Vsevolod Dolgopolov, Barbara Drynia, Andrzej Himmel, Wojciech Iwanowski, Gabor Jurida, Mohammad Khan, Eva Kubove, Grace Ormstein, Joseph Nguyen, Mohammed Radmard, Basel Salhoot, Barbara Szymkowski, and Marek Walczak.

The following senior scientists (PhD), microbiologists, pharmacists, and engineers at the BRI and the BC participated in basic research: Robert Waldbillig, Majciej Klimczak, Elwira Ilkowska-Musial, Leszek Musial, Anna Baranowska, Piotr Kuligowski, Ryszard Madry, Donat Manek, Mike Mokrzycki, Andrzej Wieczorek, Anna Wisniewska, Kris Wisniewski, Irma Witkowska, Dennis Wright, and Iwona Zapedowski.

I’ll paste Rhys’ post below in case his site is down.

Read the rest of this entry »

One Year On: Libel Reform Update

December 2nd 2010 at the Free Word Centre: an update on the progress of the Libel Reform

all-important refreshments

campaign.

Hosted by Jonathan Haewood of English Pen, John Kampfner of Index on Censorship and Tracey Brown of Sense About Science.

English pen have their photos from the evening on Flickr; I managed to avoid being in any of them this time!

From the literature distributed at the event:

The One Year On event follows weeks of further revelations of the impacts of the libel laws:

- Plastic surgeon Dr Dalia Nield was threatened with libel action by the manufacturer of a ‘Boob Job’ cream for saying she was concerned the product was potentially dangerous*

- A survey of bloggers and online forum hosts found that bloggers are particularly affected by the libel laws as they work without the support of a large company so suffer an inequality of arms, particularly where they are writing about companies, institutions and products.

- Yahoo!, AOL (UK), Mumsnet and the Internet Service Providers Association told Prime Minister David Cameron that the current laws make ISPs liable for content hosted by them and means material can get taken down in response to a threat when there may benothing defamatory about it.

* This is in reference to Rodial’s product, a cream called “Boob Job” – covered by Ben Goldacre, and we also mention it in Episode 7 of Super-Duper Woo-Fighting Duo!

Introduction

We were first assured that people’s counter-arguments have led to modification of positions and proposals within the campaign – differing interpretations have been taken on board and the aims of the campaign modified accordingly (in true skeptical fashion!).

It has sparked the first serious public discussion on libel in the UK; no insignificant achievement.

More MPs signed the libel reform EDM than any other in parliament. All parties made a commitment in their manifesto. A Libel reform bill has also come through the lords.

And, of course, Simon Singh won his appeal! Leading to the “Fair comment should be strengthened and clarified” resolution.

In addition, Jonathan has written:

In a year’s hard campaigning we’ve seen a lot of activity – but nothing has actually changed. We are now looking to the Government to produce a Bill that protects the public interest and recognises our changed media environment. We are commmitted to upholding free speech, reputation and access to justice – we just hope that the Government is too.

However, there have also been worrying trends. Scientists, publishers and bloggers are still  regularly being threatened with libel writs.

At the very least we can probably accept that everyone wants to:

- protect free speech

- recognise the importance of reputation

- maintain access to justice

Richard Allan

(Director of European policy, Facebook)

He states the importance of being able to talking with people as freely as possible, then mentioned the “Twitter bomb threat” (which prompted me to tut loudly; people need to stop calling it a ‘bomb hoax/threat’ because it wasn’t) – speech issues are on the agenda in both the public and political spheres.

In his view, the objective is: legal support for speech (as long as that speech isn’t illegal; i.e. recognise the existence and [lack of] implications of casual talk or ‘the Pub vs. the public) – let’s have a better environment.

They don’t want to have to respond to solicitors’ casual threats of libel. Instead:

- The complainant should go to the author first

- Obtain documents from court to say it’s a genuine complaint

Internet companies take content down first and ask questions later! (Once bitten…)

There needs to be a single publisher rule; a limitation of 1 year; long enough for someone to take action if it is in fact actionable.

Facebook is globally accessible but libel tourism isn’t acceptable.

We need to respect that people have views on things – they do and will continue to discuss them in public fora, including online.

Unless this is understood, it is simply “an accident waiting to happen” – will it take a few solicitors to pick it up and run action to have dramatic chill, before things change? Let’s get legislation now rather than fix it after the fact.

Emily Cleevely

(Head of Policy, Publishers’ Association)

Emily started by asserting the value of publishing and why it’s in the government’s interest to protect it, having generated £4bn revenue in the UK in 2009; up 2.6% in 2010 – in the current market. If we’re to get out of the recession, surely we should be supporting growing industries?

Is publishing the key? It also aids with social mobility e.g.  in the form public libraries.

Creativity should be protected – authors must have freedom of expression without great fear of libel action. Not just trials but also the threat of libel, the chill, that convinces too many that silence is a safer option.

Emily gave the example of Wayne Rooney’s book, which apparently had a lot of things taken out/changed. Not sure anyone was too impressed with this point, particularly Matt

The PA will continue to be active in politics and media regarding Libel Reform.

Most interestingly, Emily gave some stats from a survey conducted in October this year regarding the effects of libel on PA members (which will be published in a January 2011 report): 100% (of the 65% total membership that participated in the study) said they had modified content or language in a book prior to publication to avoid the risks presented by current UK libel laws.

Richard Mollet, CEO of the PA, said:

The Publishers Association has been campaigning for libel reform for many years and is concerned about the chilling effect which the current law has on freedom of expression. The results from our survey demonstrate that libel law as it currently stands is a huge burden to many publishers in the UK and may act as an obstacle to growth, innovation and freedom of expression within the sector.

Tom McNally

(Minister of State, Minister of Justice)

[Most of the time he was speaking, I kept wondering what he was fiddling with in his jacket pocket. Anyone else??]

Having only been a minister for 6 months, McNally wanted to quote the ‘Dick’ Crossman diary (1964) on ministerial duties [roughly, as I couldn't quite write fast enough!]:

One of the curious features is that one cannot distinguish day from day or night from night

[I think that's the case with plenty of jobs, to be honest!]

He did say we “should have a Draft Bill in Spring” (which means sometime before June 1st 2011)

Going from the Lords to legislation is a slow process and the importance of “future-proofing” whatever we do was emphasised.

In my notes I then have something about ‘the next parliament March 2012′ – even after reading some Wiki on our parliament, I don’t know what he/I meant by this (please comment if your memory and political/legal understanding is better! This is not difficult to achieve, mind).

McNally implored us to continue:

Don’t stop! … This is the end of the beginning for your campaign

The Draft Bill is a rough outline of what the government will commit to. When it comes out, we may not like phrasing and bits might be missing..!

He then addressed Simon Singh:

My son is 17 and doing Maths, Physics and Chemistry in St. Albans – your ordeal was very rough but you’re a hero to young scientists and have inspired a lot of young people in science

Which, I think, we all very much agree with.

Having read Douglas Hurd‘s paper on communications, focussing on “Quality, Diversity and Choice” – he wants to ensure we have that in our media, unrestricted by the libel laws.

Questions

Q (DAG): Do the activists only come in after bill publication – can’t we input now? [Tom A: wait a bit!] You said ‘hopefully’ there will be a slot in 2011/2012 – does that mean there might not be one? [Tom A: No minister can commit to anything in the preceeding financial year]

Q: Have you considered vulnerable writers (like the disabled) and the use of sensitive/offensive terms – legislating on which are acceptable, and how does one defend one’s reputation? [Tom A: regarding hate crimes, the issue hasn't come into libel reform yet] – I think the general opinion here was that this was a bit of an irrelevant/off-the-mark question.

Q: (Simon) – Interview in Aus with Questions: regarding homeopathy – threat of London libel. Someone blogged anyway. People someone quoted have asked to be anonymous for fear of libel. [Tom A: Contrasting legal advice: is the Master of Rolls looking?] From the audience: “At every stage…” – some ramble that didn’t mean a lot, from where I was sitting!

Comment: (Síle Lane) – from a Sense About Science survey, of the editors of scientific journals (in all subject areas):

- 32% have been threatened with libel action

- 44% have asked authors to modify articles

- 38% have refused to publish due to fear.

Tom A: We’ll try! We can’t go into detail; we need laws to protect science discussion and criticism. Legislation needs to be right, not flawed and open to criticism. Then a comment about public opinion/support that I missed – perhaps, the public generally supports making sure scientific claims & criticisms can’t be silenced by legal threats? I don’t know if there have been any surveys on this.

Q (Evan Harris): A claimant lawyer can make their case (and have it rejected!) –  we need to create a public interest defence; incorporating a ‘threshhold’ of damage caused to reputation (in this country), given what is published abroad. [Tom A: Something about the Lester bill and 2 sides interacting, that I missed. Plus, there's another chill for people with 'media intrusion', who are met with "don't like it? See you in court"]

Response (Evan): Individuals need to be able to sue. Companies, less so. [A: this must be looked at.]

Comment (Nigel Tait – Carter Ruck (!) ): ‘Please don’t worry about us lawyers!’ – because they’ll keep making money regardless, basically. Which is true.

Q: (Tracey Brown) – Is it a good thing (economically) that London is a litigation centre? There are other ways though;  so that we would not be blocking world discussion, but leading it.

Q: (Matt Flaherty) – The recent Supreme Court case that replaced “fair comment” with “honest comment” – how big a deal is that?

- we didn’t get an answer to Matt’s question, sadly, even though it was arguably the best one (but perhaps we’re just biased ‘cos we love Matt. Still, it’s a shame no one offered a response).

Q: I want to bring up the elephant in the room, or perhaps the country; I’m sympathetic to PA and Facebook but what about people exposing military abuse; will you allow Assange to stay in the UK? – people chuckled at this a bit.

Richard makes a joke and someone says “Assange is not a subject for mirth”.

(Richard): Sorry, World insanity causes me to resort to black humour! When you hear of people ordering assassinations for something the person has said, that’s just insane.

A (Tom): I Can’t answer this! Ask the attorney general. Q: What’s your view of the leaks? Patience! – is all I’ve got in response to that, but I can’t remember if any more was said.

Comment: The burden of proof is not actually biased to the claimant (I had a semi-drunk argument/discussion about this – the unfairness of the law re: the accused who makes the libellous comment – in the old London SitP pub, then about 2 weeks later I bumped into the guy at Westminster Skeptics and he said I was right and he’d been talking rubbish. Always nice to know!).

Q: One of the main reasons for libel tourism is that our lawyers charge 40-50x fees! No one can afford this! Would the lawyers really want to remove this source of income?

A (Joanne Cash): – Yes we will go against our paychecks! “If you need any help, you know where I am!”

Comment (Emily): People ask about the value of science vs. creative works and biographies. Science must be critiqued. Perhaps there should be a seperate – legal, if I recall -category for science?

Audacity! We use that for Superwooduo

Hey, Audacity! We use that for SDWFD(wc)

Personally I don’t think I agree with that. If you start treating science as a really special case, this could potentially damage an already shaky relationship with the layperson. Though evidence-driven criticism is especially vital in science and particularly medicine, I don’t see why such criticism should be actively discouraged (with such great effect as the current libel law has) in any field.

Closing comments

Tracey: When we started, we heard “don’t bother” because: it’s too complicated; you’re small; the government is uninterested.

Remember this is as much about the public right to read as for people to speak. Uncertainty leads to debate and often uncovering the truth.

For example, take the case of Peter Wilmshurst as one that gives a simple perspective (we  want the public to be made aware of things that might be dangerous, rather than people deciding not to speak out to protect others, for fear of losing their house, their job, their livelihood).

When small people say things to power sometimes things happen

I’m sure many of us still like to think that could be true.

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