That probably sounds like a crazy enough conspiracy theory on its own, even before I tell you that Dr Burzynski has form for fraud. If you want to catch up with my previous posts about the Burzynski Clinic, you can read them here, here, and here.

One of the obvious red flags of quackery that alerts us to the likelihood that Burzynski’s treatment is worthless is his lack of publications. He has registered 61 clinical trials of antineoplaston treatment, and yet I can only find one of them with published results (and even in that study, most of the patients died). What happened in the other 60 studies? We can only guess, as the results have not been published.

So why hasn’t he published the results of the other 60 studies?

There are a number of possibilities. One possibility is that the results were dreadful and show that antineoplastons are not only worthless, but positively harmful. If that’s true, and if Burzynski is more concerned with making money than with ethics, then perhaps he chooses not to publish in the hope that potential customers will not learn the truth about antineoplastons.

Another possibility is that the results show that antineoplastons are wonderfully effective, but he’s worried that if he publishes the results, other people will start using them and it will hurt his business model. That wouldn’t be very ethical. It wouldn’t even be very good business sense. If antineoplastons were effective, I imagine he could do some licensing deal with one of the big pharma companies that would make him far more money than he could ever hope to make at his own clinic.

Supporters of Burzynski reject both those possibilities, of course, and propose a third. Part of the conspiracy theory mythology is that Burzynski has repeatedly tried to publish his results, but his attempts have been suppressed by the Lizard Overlords Big Pharma.

On the face of it, that sounds highly implausible and nothing but part of a crazy conspiracy theory.

But I’ve been thinking a bit more about this, and it’s occurred to me that there just might be a grain of truth in it.

I’m not suggesting there is some grand conspiracy in which Big Pharma pay off the journals to reject his papers, of course. But maybe medical journals really do routinely reject his papers.

Why?

Well, there are widely accepted ethical standards that have to be followed in clinical research. The best known codification of these standards is the Declaration of Helsinki. Among other things, these standards require that clinical trials must follow a pre-specified protocol which has been approved by an independent ethics committee, and that patients taking part in the trials must have given informed consent. That consent must be based on a clear explanation of what happens in the trial and be freely given.

Most respectable medical journals require that those standards have been met, and refuse to publish papers based on research that did not conform to those standards.

Is it possible that this is the reason why Burzynski’s research has not been published? Certainly, his ethics have come into question in the past. The FDA found that the Institutional Review Board tasked with approving his studies was not following appropriate procedures. Burzynski is currently facing legal action from a former patient who alleges, among other things, that she was entered in a clinical trial without her knowledge. If true, that’s an extremely serious breach of medical ethics.

Taking all this together, it does seem plausible that Burzynski might have submitted many more trials for publication than we know about, but that the papers were rejected because the trials did not conform to accepted ethical standards.

I should point out that this is pure speculation. I have no evidence that Burzynski has had papers rejected for this reason. Nonetheless, it is a familiar refrain of Burzynski’s supporters that he’s repeatedly tried to publish his results and been repeatedly rejected. That’s quite possibly conspiracy theory nonsense of course, but it just could be true if the journals who received the submitted papers realised that the trials did not follow accepted ethical standards.

Does anyone out there have any more information? Is there any evidence that Burzynski has submitted papers that have been rejected, other than the bluster of conspiracy theorists? Please let me know via the comments form below if you can shed any light on any of this.

Why hasn’t Burzynski published his trials? Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

I’d like to share with you something that happened at the meeting I attended yesterday evening. One of the applications had some rather odd things about it. It was really not clear to us why the applicants had designed the study in the way they had, rather than in a way that would be far more usual and ethical for the sort of study they were doing. There might have been good reasons for it, but without understanding what those reasons were, we did not feel that we could approve the project. There was no attempt to justify the odd design in the application, or even any acknowledgement that the design was odd.

Normally, such things would be discussed at the meeting when the applicant turns up. In this case, however, the applicant did not turn up. It’s hard to understand why not. They were a large and well resourced team, and even if the chief investigator hadn’t been available, surely someone else from the team could have come. We could then have discussed their project, and they could have explained to us why they were doing things the way they did.

But as that wasn’t possible, we had to take the rather unusual step of issuing a verdict of “no opinion”. This means that we felt we simply didn’t have enough information to assess the project. It will now mean that it takes a lot longer for the project to be approved than it would have done. To be fair, we were never going to approve it at last night’s meeting anyway, as there were a number of other problems with the study, not least that the patient information sheet read as if it had been written by lawyers and was a text-book example of how not to write a patient-friendly information sheet. But if we’d understood more about the study, we could at least have issued a provisional opinion that would have meant the study could have been approved once the patient information sheet had been edited torn up and written again from scratch. Attending the ethics committee meeting is really such an important part of the application process, often allowing areas of confusion to be cleared up quickly and without generating more paperwork, I can’t understand why anyone would not take the opportunity to do so.

So, for anyone thinking of applying to an ethics committee for permission to run a clinical trial, I have 4 pieces of advice.

1. Do make sure you think carefully about your study, and design it in accordance with best professional standards
2. If there are good reasons why you need to do things in an unconventional manner, carefully explain what those reasons are in your application
3. Always make sure you attend the ethics committee meeting
4. Always make sure you attend the ethics committee meeting

The more eagle-eyed among you will have spotted that the last 2 of those are the same. It’s such an important point I thought it was worth repeating.

The importance of attending the ethics committee meeting Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

Well, I now have a development to report. The PCC have considered my complaint, and have ruled that the Observer article, while it was indeed misleading, did not breach the code, because it was somebody’s opinion rather than a factual article.

I’m not sure what the point of a code prohibiting misleading information is if there is such an easy get-out clause for newspapers who wish to breach it. I do hope Lord Justice Leveson is listening.

The PCC’s full judgement is as follows:

The complainant considered the article, a column piece on the newspaper’s decision to print an earlier article relating to the Burzynski Clinic in Texas, had breached Clause 1 (Accuracy) of the Code. The columnist had omitted important information about the activities of the clinic in a way that had been misleading.

The Commission made clear that under the terms of Clause 1 (i) of the Code newspapers must “take care not to publish inaccurate, misleading or distorted information”, and that under Clause 1 (iii) newspapers whilst “free to be partisan, must distinguish clearly between comment, conjecture and fact”.

The Commission acknowledged the complainant’s position that the article had been misleading in not citing important concerns with regard to the medical treatments offered by the Burzynski Clinic. However, the Commission noted the article had been written as an opinion piece, intended to allow the columnist to express his views on the controversy that had been stoked by an earlier article about a family who had decided to use the clinic’s services. The commission made clear that columnists are entitled to express their personal views and comments – however controversial they might be – provided that they are clearly distinguished from fact. The Commission considered readers would have understood that the article had not been intended as a piece of factual investigative journalism into the Burzynski Clinic and its activities. Furthermore, the Commission noted the article had highlighted concerns with regard to the treatments offered by the clinic; specifically highlighting the view that the treatments would not satisfy the regulatory requirements of the UK. As such, the Commission considered readers would have understood that significant controversy existed with regard to the activities of the clinic. While acknowledging the complainant’s concerns, the Commission considered the article had been clearly distinguished as comment and as such did not establish a breach of the Code.

Update 7 Feb:

I forwarded the PCC’s judgement to the Leveson Inquiry. I have had a nice little email back from them thanking me for sending it and telling me that my comments have been noted by the inquiry team. I doubt that it will be the only piece of evidence they receive that may suggest that the PCC is not fit for purpose.

Burzynski Clinic in the Observer: PCC response Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

Professional medical writers’ organisations such as EMWA, AMWA, and ISMPP have done their bit by publishing guidelines and position statements and educating their members about ethical publication practices, and there is some evidence that those efforts are pushing things in the right direction, but it’s clear that they are not going to solve the problem by themselves and that more needs to be done.

So what more can be done?

Well a paper recently published in PLoS Medicine by Bosch et al argues that the best way to deal with it is through legal action. Of the paper’s 3 authors, 1 is a lawyer and another declares an interest in doing consulting work for a law firm, so they would say that, wouldn’t they? It appears to be hard to talk about ghostwriting without conflicts of interest rearing their ugly head.

Now, I don’t want to completely pour scorn on the idea of legal action. It’s an interesting idea, which I suspect could be appropriate in some of the most egregious cases of publication malpractice, and would certainly make people sit up and take notice if it were successful. The deterrent effect of a couple of high profile cases could be quite valuable. Bosch et al suggest that authors of dishonestly written papers could be named as defendants in any legal action relating to harms to patients that result from physicians relying on those papers in their prescribing decisions, and if harms do result in that way, then it’s hard to argue that the authors of the papers aren’t responsible. I wonder if the action could even be extended to the journal that published the paper, although Bosch et al don’t mention that possibility.

However, I think suggesting that legal action is a sensible way forward in the majority of cases is misguided (unless, of course, you’re a lawyer or a consultant to a law firm, in which case I dare say you’ll do very nicely thank you). Legal action is time consuming and extremely expensive, and is going to be completely impracticable as a way of dealing with most unethically written papers.

I know I’ve said this before, but I think it bears repeating: we are never going to get rid of ghostwritten papers unless journal editors start to take the problem seriously (and by taking the problem seriously, I mean actually DOING something about it, not just publishing articles moaning about how terrible the problem is). But as Bosch et al rightly point out, journal editors have not shown a willingness to tackle ghostwriting. And that leaves us with a problem.

I don’t know how we can encourage journal editors to do their bit (although if they did find themselves on the wrong end of a couple of high profile lawsuits involving ghostwritten papers that they published in their journals, I suspect it might focus a few minds), but the question of editorial responsibility is something that’s cropped up in a couple of other contexts recently, and I think it’s worth drawing some parallels.

The first context is my unpleasant experience of finding defamatory material published about my company in the Journal of Bioethical Inquiry. It turned out that, unless I was willing to go down the legal route of suing for libel, which I wasn’t (did I mention that legal action is expensive and impracticable in most cases?), my attempts to have the record corrected were dependent entirely on the good will of the journal editor. If that good will was absent, as it turned out that it was, there was nothing I could do about it as there is simply no mechanism for enforcing ethical behaviour on journal editors who misbehave. Although COPE claim that they investigate complaints against journal editors, their total lack of transparency in their complaint procedure makes it hard to have confidence in the process.

My friend Karen Shashok wrote a detailed article analysing the Journal of Bioethical Inquiry case, in which she argued that a mechanism for making journal editors accountable for their actions is badly needed.

So, if there were a body that was able to hold editors of biomedical journals accountable for their actions, would they be able to take action against journals who publish ghostwritten papers? I don’t know the answer to that, as it’s all a bit hypothetical. But doesn’t it sound like an idea worth pursuing?

It’s also hard to talk about editorial accountability without thinking of the Leveson Inquiry, currently ongoing in the UK. This inquiry is focused on mass media, rather than scientific journals, but perhaps some of the ideas of editorial accountability that will come out of that inquiry could be applicable to journals too?

Legal remedies for ghostwriting Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

The chairman of the editorial board of the journal, Paul Komesaroff, has now responded to Shashok’s article, and his response has been published on the EWMA website. Komesaroff’s response is not concordant with my own understanding of what happened. In this post, I shall explain what really happened with reference to the actual content of the emails that were exchanged, so that you can make your own mind up about the accuracy of what Komesaroff claims.

Komesaroff begins his response by saying “In science and scientific writing the first rule is to ensure that the facts you are reporting are correct”. On that point, at least, we agree. However, Komesaroff doesn’t have a good record of living up to that ideal, as he has consistently refused to correct the article that appeared in his journal which falsely accused us of ghostwriting.

Let’s look at some of the specific points Komesaroff makes. He makes a great many points, some of which are not particularly important, and if I attempted to respond to every single one this blog post would become unreadably long. So I’ll concentrate on the most egregious inaccuracies. Actually, this is going to be quite a long post anyway, but I hope you’ll bear with me, because I think it’s important to put the record straight.

In the introduction to his response, he says that I threatened to take legal action for libel and refused to withdraw that threat. While it is true that I raised the possibility of legal action in some of my earlier emails with Springer, the publisher of the journal, I subsequently make it perfectly clear that I had decided not to go down that route.

Once I realised that Komesaroff believed I was making legal threats (he didn’t actually tell me this himself, but I learned about it second hand as a result of correspondence between Komesaroff and Karen Shashok) and that he was using this as a reason not to correspond with me, I sent the following email on 18 July 2011:

Dear Dr Komesaroff

I think there may have been a misunderstanding here. I gather from correspondence with Karen Shashok that you are under the impression that I am threatening legal action, and that it is the threat of legal action that is inhibiting you from engaging in discussion.

I’m not sure why you believed that to be true, but I’m happy to confirm that I have no plans to take legal action.

Now that we’ve cleared that up, are you willing to discuss the article?

Kind regards

Adam

In the light of that email, I’m sure you can make up your own mind about the truth of Komesaroff’s claim that I made a threat of legal action which I refused to withdraw.

Moving on to the section of his response entitled “The facts of the matter”, point 6 says that the original article in JBI did not make any claims about unethical conduct by Dianthus Medical. That is rather disingenuous. While it is true that the article did not use the precise words “unethical conduct”, that was the clear implication of the article. We are accused of ghostwriting, and most people understand that to be unethical. Moreover, the description of ghostwriting in the paper leads the reader in little doubt that it is not a good thing:

“A ghostwriter includes messages to maximize the marketing power of the publication while one or more “honorary” academic authors lend their names, titles, and purported independence to the paper (Moffat and Elliott 2007). While the audience may look suspiciously on a paper with an all-corporate authorship line, the presence of an academic author lends the air of independence and prestige, making the article appear more credible. The academic authors may review an outline or draft, but typically perform little writing.”

In point 9, Komesaroff claims that I was asked which statements in the article needed to be corrected and that I “consistently refused to identify a single false, inaccurate, or misleading statement”. I disagree. Komesaroff emailed me on 19 July 2011 to ask what specifically I thought was wrong with the article. I replied to him the next day with the following email:

Dear Dr Komesaroff

I can assure you that I am most certainly genuinely interested in resolving my concerns, so I am happy to answer your questions.

The claims in Spielmans & Parry’s article that I object to are in the section entitled “Writing firms”, on the 6th page of the pdf version of the article.

The first paragraph of that section mentions my company specifically by name, as an example of the sort of company that indulges in ghostwriting. The following paragraph then states:

“The process is relatively simple: A ghostwriter includes messages to maximize the marketing power of the publication while one or more “honorary” academic authors lend their names, titles, and purported independence to the paper (Moffat and Elliott 2007). While the audience may look suspiciously on a paper with an all-corporate authorship line, the presence of an academic author lends the air of independence and prestige, making the article appear more credible. The academic authors may review an outline or draft, but typically perform little writing.”

Although it’s not explicitly stated that my company operates in that manner, by following the paragraph in which my company is mentioned with that statement there is a clear implication that that is how we write our papers. I’m sure that any reasonable reader would infer (assuming they believe the article to be accurate) that the description of ghostwriting given above applies specifically to my company.

You mention the letter that I published. There are three reasons why I don’t believe that to be sufficient. First, the letter is not bibliographically linked to the original article via the journal’s website. It would be perfectly possible for anyone to read the original article without being aware that my letter exists. Second, Spielmans and Parry wrote a reply to my letter in which they made further allegations, and the journal did not give me an opportunity to respond to those allegations. Thirdly, I think it’s rather bad form of a peer-reviewed journal to publish a paper which makes up allegations on the basis of supposition, rather than evidence, and any journal with the word “ethical” in its title should surely wish to publish an apology in such circumstances.

What I would now like to happen is for the journal to publish an apology and a correction to the article, bibliographically linked to the original article, so that it would be clear from the article’s web page that the correction exists. As I am sure you will have seen in previous correspondence, Spielmans and Parry agreed to some wording of a correction that they would find acceptable (I attach a copy in case you no longer have it to hand). When the authors themselves agree that a correction to the article is appropriate, I cannot see any reason why the journal would not wish to publish it.

I look forward to your response.

Kind regards

Adam

Komesaroff apparently does not believe that the above email identifies “a single false, inaccurate, or misleading statement.” I think that email was perfectly clear about exactly what I thought was misleading in the article. If Komesaroff thought that my email wasn’t sufficiently clear, he could have emailed me back to say so, but instead he emailed back to say that he was not prepared to engage in any further correspondence.

In the final paragraph of his “The facts of the matter” section, he states that I “admit that no errors have been committed”. Given the email I quoted above, I’ll leave you to make up your own mind about the truth of that statement.

This whole episode is bizarre. The journal published some unfounded allegations against us. That’s not hugely bizarre. Many papers containing statements that didn’t get thorough fact-checking are published in peer reviewed journals. What is bizarre has been the journal’s response when the error was pointed out. Surely a reputable journal would wish to publish a correction when it is pointed out that they have published a misleading article? This should be particularly true when the authors of the article themselves agreed that they had no evidence for the allegations and have agreed that a correction (although they preferred to describe it as a “clarification”) would be appropriate.

But instead, Komesaroff has invented a fictitious threat of legal action as a reason to break off any discussion of the article. That threat did not exist, as I have proved above. But even if it did, I cannot understand why it would make it OK for the journal to allow a misleading article to stand uncorrected. Surely the important thing is the accuracy of the published record?

The JBI saga continues Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

You might argue that the FBI therefore dashed the hopes of many investors, by cruelly taking away their expectations of making great returns on their investments, and that clearly the FBI are the bad guys in this case.

What’s that? You wouldn’t argue that the FBI were the bad guys? Well, I guess you don’t work for the Observer newspaper then.

A rather extraordinary article appeared in yesterday’s Observer. This was a follow up to the article they published 2 weeks ago, in which they talked about the Burzynski Clinic, and which was the subject of a recent blogpost of mine. The Observer had, quite rightly, received much criticism of their previous article, as it did not make clear that the Burzynski Clinic offers worthless treatments at exorbitant prices, thus exploiting vulnerable people for financial gain.

So was this article an apology for publishing such a poorly researched and uncritical article? Far from it. Now, we all make mistakes. It is disappointing that the Observer published the article they did 2 weeks ago, but at least the Observer have now had plenty of feedback and have had a chance to learn from their mistake. A mature and responsible organisation would print an apology and explain how they have learned something.

But sadly, we are not talking about a mature and responsible organisation here. We are talking about a newspaper. If you believed that newspapers were mature and responsible organisations, then clearly you have not been following the Leveson Inquiry.

So, the article in yesterday’s Observer, far from apologising, attempted to justify what they did and, astonishingly, blame the people who had uncovered the truth for causing harm. This is pretty much exactly analagous for blaming the FBI for the fact that Madoff’s clients lost a lot of money.

The Observer appear, despite having had it explained to them many times, to have completely failed to understand the nature of the Burzynski Clinic. They acknowledge that its treatments are unproven, and offer a half-cocked apology for not including information on criticisms of the clinic, but continue to peddle the line that it is a legitimate clinic offering “experimental” treatments. It is hard to know whether this is because they really have no-one on their staff with even the most rudimentary training in assessing health stories, or whether they responded to all the emails they received by the electronic equivalent of sticking their fingers in their ears and shouting “la la la I’m not listening”. I really don’t know which would be worse.

The Observer claim that pointing out that the clinic is bogus is a cruel thing to do and causes distress to the families who are being treated by the clinic. Well, it may well cause distress. But do the Observer think that it’s therefore better to remain silent about any concerns and encourage the clinic to continue taking advantage of vulnerable people? Really?

The idea that the clinic offers experimental treatments that are not guaranteed to work, but might just work anyway, is a seductive one. But sadly, it is wrong. There is a difference between an experimental treatment and a worthless one. An experimental treatment, after more than 3 decades of research, would have produced evidence of efficacy if in fact it did work. Such evidence is completely lacking for antineoplaston treatment.

The ethics of the clinic are also highly questionable. Charging patients life-changing amounts of money to take part in scientifically dubious clinical trials that have no realistic chance of benefit is simply not ethical. It is noteworthy that the Burzynski Clinic’s Institutional Review Board (which in theory is supposed to ensure that trials done at the clinic meet appropriate ethical standards) was heavily criticised by the FDA for not following proper procedures in 2009. I don’t know if they’ve since fixed the problems and are now complying with the law, but when I asked what progress had been made on the Burzynski Clinic’s Facebook page, my question was deleted. Hardly the action of an organisation behaving ethically and with nothing to hide.

It is terribly sad when people are facing the loss of their children to cancer. But pretending that someone can cure them when it just isn’t true does not make things any better. It’s just dishonest, and I suspect that it causes more hurt in the end. It is disappointing that the Observer have chosen to take such a dishonest line about the Burzynski story. I have reported them to the Press Complaints Commission on the grounds that their article was misleading, and will report back with any developments.

The Burzynski Clinic part 2 Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

I am completely and utterly baffled by this. It is being presented as if it is something new. It isn’t. The General Practice Research Database (GPRD) already contains vast amounts of anonymised data from NHS patients, and can be made available to private companies who are prepared to pay the appropriate fee. This has been going on for many years. Indeed, I have analysed data from the GPRD on behalf of pharmaceutical companies myself on more than one occasion.

So what exactly is new here? The GPRD contains records only from primary care, so perhaps the idea is to make data from hospital records available as well. But if so, that hardly warrants a huge fuss. It is simply an extension of an existing scheme rather than anything really new.

What would be new, and would indeed be worthy of a massive fuss (if not rioting in the streets) would be if there is a plan for non-anonymised data to be made available. I do hope that’s not what is being proposed.

I am totally confused. Can anyone explain what the story doing the rounds in the media is really about?

Making NHS health records available to private companies Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

It is understandable that when you find yourself in that situation, you will be prepared to clutch at straws. If someone offers you a hope of a cure, you’d take it, wouldn’t you, even if you knew that the chances of a cure were slim?

Well, that is what the Burzynski Clinic is offering. They are offering a treatment called “antineoplaston therapy”, for which they charge tens, if not hundreds, of thousands of dollars. That would all be worth doing if antineoplaston therapy had shown evidence of being able to cure brain cancers.

But, despite the marketing efforts of the Burzynski Clinic, there is sadly no evidence that that is true. And it’s not because antineoplastons are a new treatment that have not had time to be properly researched. The Burzynski Clinic have been running trials with antineoplastons since the 1980s, but despite that, they have yet to provide any evidence from randomised controlled trials that the treatment is effective. While I realise that absence of evidence is not the same thing as evidence of absence, I really believe that if no evidence has been found after all that time, then the only reasonable conclusion to draw is that antineoplaston treatment does not work. I would be delighted to be proved wrong, of course, but it’s hard to see that happening after 3 decades of research have failed to come up with anything convincing.

There are further reasons to doubt the bona fides of the Burzynski Clinic. Dr Burzynski has previously been successfully sued for fraud, having attempted to claim reimbursement from a health insurance company for antineoplaston treatment when it was not covered by the insurance. It is also hardly the act of a reputable institution that, when faced with blogs criticising antineoplaston treatment, the clinic uses vague and unprofessional legal threats, rather than attempting to explain why the critical bloggers were mistaken.

I’m afraid the only conclusion I can draw is that the Burzynski Clinic, whether knowingly or perhaps through simply not understanding the limitations of their treatment, are taking advantage of vulnerable and desperate people, charging them life-changing sums of money for treatments that have no realistic hope of any benefit.

There are some other excellent blogs about the Burzynski Clinic, which I encourage you to read:

False hope

How much does hope cost?

The weird world of US ethics regulation

The false hope of the Burzynski Clinic

The Burzynski Clinic

Controversy surrounding Burzynski’s ‘pioneering’ cancer therapy should be reported in newspapers

And finally, Ducks are nuthin’ but trouble, which contains a list of links to other blogs on the subject.

The problems with the Burzynski Clinic are thus very well documented in the blogosphere. What I don’t understand is why the mainstream media have been silent about, or even complicit in, this scandal.

The Burzynski Clinic Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

My friend Karen Shashok has recently written a very detailed account of the episode, and draws some wider conclusions about editorial accountability in general. It’s well worth a read.

Journal of Bioethical Inquiry and editorial accountability Dianthus Medical - An innovative company providing outside the box analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

The instinctive answer of many people to that question is “no”, but most health economists would say that not only can you put a price on a human life, you absolutely need to do so. Certainly when running a health service, the only rational way to decide whether interventions make economic sense is to do exactly that.

Health Technology Assessments from NICE use the principle of valuing a human life when they make decisions about whether health interventions are cost effective on the NHS. They set a threshold of £30,000 as the price of one year of life in good health, although it’s not necessarily rigidly applied in all cases. What an appropriate threshold should be is of course a matter of great debate, but the fact that a threshold exists above which it is simply not rational for society to pay to save a life is not controversial. As I have argued before, more than once, it is essential to put a value on human life in this way when resources are finite, as of course they always are.

Now, the government has recently proposed increasing the speed limit on motorways from 70 mph to 80 mph. I think it’s quite interesting to consider the question of putting a value on human life in this context. The government argues that there would be economic benefits to increasing the speed limit, in that people would get to their destination faster, thus saving time, and we all know that time is money. On the other hand, we would also expect that raising the speed limit would lead to more crashes and more deaths.

As an aside, I do not see the argument of economic benefits as completely self-evident. It is certainly not true that car journeys will automatically take 7/8 of the time they took previously. A typical motorway journey includes time spent driving between urban start and end points and the motorway, stopping at a services for a coffee break on longer journeys, and time spent driving slowly in congested sections of motorways. None of those would be affected by the speed limit. So time savings would, in percentage terms, be small. There is also a possibility that, counter-intuitively, faster speed limits could even slow down journey times, as they may increase the risk of congestion. One widely used scheme for reducing congestion, most famously used on the M25, is to decrease speed limits when traffic is heavy, thus reducing stop-start driving that leads to congestion.

And, of course, any economic benefits of faster journey times would be offset by increased fuel consumption. Wind resistance increases with the square of speed, so there is more difference than you would think between 70 mph and 80 mph in fuel consumption.

So, while there may be economic benefits to increasing the speed limit, I would like to see how they have been calculated before I believe that they exist.

But anyway, let us accept for the sake of argument that there are economic benefits to increasing the speed limit, as that is how we get into the interesting ethical question.

Suppose that the economic benefits to the UK economy as a whole, taking account of the net effect of faster journeys and increased fuel consumption, were to be reliably estimated at, say £10 million (that’s a figure plucked entirely out of thin air just for the sake of argument, and I make no claim whatsoever that it’s even remotely close to the true benefit).

Let us then suppose that the number of excess deaths and injuries could be reliably estimated (which of course is also difficult), and then converted to an economic value using NICE’s threshold of £30,000 per quality adjusted life year.

The interesting ethical question is then this: if the figure we arrived at for the economic costs of the excess deaths and injuries was less than £10 million, would we be justified in concluding that increasing the speed limit was worthwhile?

A simplistic analysis would suggest that the answer is yes, but I don’t think it’s as simple as that.

The problem is that many people believe that there is a real moral and ethical difference between actively killing someone and passively failing to save a life. When NICE makes decisions based on the cost of a human life, it does so based on how much it costs to actively intervene to save someone who would have died without intervention. People killed in road traffic crashes on motorways will have been killed by human agency.

Is it therefore appropriate to use the same cost effectiveness threshold? I think the answer to that is probably no.

However, it gets more complex still. Imagine this thought experiment. Suppose that you could identify an individual person whose existence was known, with certainty, to be thoroughly detrimental to the UK economy. Let’s call him George (no, of course I’m not thinking of Mr Osborne, this is a purely hypothetical thought experiment). After doing careful calculations, we know for a fact that killing George would boost the UK economy by £10 million. Who thinks we should kill him? I would guess not many. While we are generally prepared to accept that there are economic limits on saving lives, I doubt that many people would want to kill a specific, named individual, no matter what the economic benefits of doing so.

The speed limit situation is somewhere in between the two extremes. We will be actively killing people, but we don’t yet know who those individuals are. We won’t even know with certainty even after we have killed them: increasing speed limits only increases the risk of death, it does not create it where it did not exist before. Anyone killed on a motorway after the speed limit increase might have been killed even had speed limits stayed the same.

So are the excess deaths due to an increased speed limit morally and ethically equivalent to not funding an expensive medical intervention, deliberately killing George, or somewhere in between?

My own feeling is that there probably is a threshold of cost on a human life which could be set here, but that it would be much higher than the £30,000 used by NICE. What do you think? Let me know via the comments form below.

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