Medical Innovation, Saatchi, and the Nature of Evidence.
Andrew’s GP threw his hands up in the air and shouted “Get out, this is not worth my job!”
Andrew, who lives with Secondary Progressive MS, had just asked his GP to prescribe an off label therapy known as LDN (Low Dose Naltrexone) which is used by thousands of people in the UK living with autoimmune/central nervous system disorders and some cancers.
There’s so much discussion of the Medical Innovation Bill right now, and a lot of it appears to be focussed on whether or not there would be any redress for patients should something go wrong. Those in favour insist there would be, those against are adamant the revised bill removes valuable protection from patients. But in all the increasingly vitriolic argument, we’ve actually forgotten about the experience of patients like Andrew, which was what prompted the Bill in the first place. So this piece aims to address those concerns only and will focus on the nature of evidence versus anecdote as far as patients and their families are concerned.
So shocking was his doctor’s response to Andrew’s request to be prescribed an affordable, non-toxic, and anecdotally very effective drug, that his partner, Jayne Crocker, was moved to start a campaign, LDNNow, “a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for”.
“Andrew complained to the local health board about his GP who had appeared to be in favour of Andrew being prescribed LDN, providing Andrew got the necessary support/documentation from his neurologist” Jayne explained to me. “Once in receipt of that documented support, we made another appointment expecting the GP to write the prescription. What happened was an outrage with being told to get out of his office it wasn’t worth his job.
“This is undoubtedly unacceptable behaviour from a medical professional and on our complaint the Health Board contacted the GP practice and as a result we were seen by the senior GP” Jayne continued, “but as it is an off-label therapy, that GP felt the need to contact his lawyer to see if he could prescribe LDN and the lawyer came back a few days later and said “No”!”
“It’s incredible” said Jayne, “we found ourselves in a position where a lawyer was advising a GP whether or not to prescribe an off label therapy. Surely the GP is best placed to make this decision especially when requesting a treatment that has proven to be non toxic for a disease that is progressive and where there are no other non toxic options”.
Yet the other main objection loudly repeated by detractors of the Medical Innovation Bill is that there is no need for the Bill anyway because there is “no evidence” that doctors would refuse to prescribe a potentially useful drug to any patient out of fear of legal reprisals.
A statement from Cancer Research UK says “We have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer”. The Motor Neurone Disease Association also state that “such a problem does not exist: uncertainty around the law or fear of litigation do not, as far as we can see, dissuade doctors from trying new treatments”.
Several large organisations have corroborated this; these include the Medical Defence Union, the NHS Litigation Authority, the Royal College of Physicians, Royal College of Radiologists, Academy of Medical sciences, Medical Research Council, Welcome Trust, and the BMA.
But from Jayne’s point of view running LDNNow, the strong claim that there’s no evidence of this fear is just not true: “the fear of doctors prescribing off label is very real. Many patients will testify that their GPs have turned them down when requesting a treatment like LDN because of the GP fears of being reported to the GMC.”
Clearly the head of the surgery whose lawyer said “no” as well as the original GP, would provide very good examples of doctors being afraid to innovate out of fear of legal action. They refused to prescribe the innovative drug, against the express wish of the patient, and clearly stated that it was due to fear of legal action, throwing their hands up into the air.
Which raises the question of how likely they would be to forward a complaint to anyone else about being put into such a position, where they are so clearly more afraid of their overlords than of losing their patient!
The territory of evidence vs anecdote is one in which scientists often repeat that “two anecdotes don’t add up to evidence”.
But hang on, there has to be a difference between an anecdote, defined by medical science as the opposite of evidence, and a person’s witness testimony about the way a doctor behaved when asked for a drug that is only “anecdotally” reported to do any good.
So what does actually count as evidence that doctors are dissuaded from trying new treatments because of uncertainty around the law or fear of litigation?
While we must all accept that there has to be evidential basis for medical treatment, if the scientific sense of “anecdote” is being applied to the level of trust that can be placed on an individual patient’s, or other individual’s account of their own experience of talking to doctors about innovation, then the definition has obviously gone much much too far in the wrong direction.
Which might then explain why so many bodies are able to claim that there is no evidence of doctors being afraid to try innovative treatments.
So for the record I’d like to add my own experience of medical hands in the air. Because would you believe it, exactly the same thing happened to me? And I do mean literally, the same thing!
When my mum was suddenly and shockingly diagnosed with lung-cancer in January 2011, we also asked her doctor to prescribe LDN, and she also threw up her hands in the air, shrieked, and then practically shouted “I’ve only got one year left in practise, I’m damned if I’m going to get struck off!”
This upsetting reaction, which terrified my mum out of her very wits, was in spite of the fact that the doctor herself then gladly admitted that she knew LDN to have been “anecdotally reported to shrink tumours”. But this knowledge did nothing to persuade her to allow a dying woman who was palliative care only, to try taking it, because of the personal legal ramifications for her, the doctor.
This refusal to co-operate, on the basis of her personal fear of getting struck off, shook my mum’s resolve to step outside her life-long conditioning of trust in the medical establishment, to insist on trying something new to save her life. The fact that the doctor admitted the anecdotal tumour shrinkage at the same time was indescribably awful.
It was only a chance informal telephone discussion with another doctor that strengthened our resolve in the matter as he was adamant that, if the patient wanted to take LDN, her GP should be approached again and asked to look into it further.
On the basis of that phone call, we did exactly that, and mum’s own doctor soon came back with more and more ‘respectable’ evidence of ‘respectable’ people trialling this drug with encouraging results. Unfortunately in the interim, whilst all this was going on, my mum deteriorated very fast, and soon died.
So that’s two doctors who initially did exactly the same thing when asked to prescribe the same medicine, which is a non-toxic affordable drug costing £1/day, which at least one of them acknowledged was anecdotally reported to shrink tumours.
That’s not “no evidence”.
Had these two doctors been able to persuade themselves not to throw their hands up uselessly into the air, but instead quickly put them to use in prescribing inexpensive, and what could prove to be effective medicine, for people admitted to have little or no other option, without the introjection of their own personal circumstances, my mum, Andrew and whoever else has witnessed this medical hands-in-the-air phenomenon, may have seen benefit from the virtuous circle that is anecdotally widely reported by LDN users.
So widely in fact that when mentioning LDN to another doctor recently, they immediately asked whether it was for MS showing knowledge and acceptance in face of overwhelming examples of the benefits of LDN in MS treatment.
Jayne told me “The advantage LDN has over other ‘off label’ medications is that not only is it non toxic but actually tricks the body into getting it to work again for itself. It is a drug that implements the biotherapy approach to 21st century medicine, which is all about artificially stimulating the body’s own defences and systems in order to restore control over chronic systemic diseases. This is how most people remain clear of these diseases in normal health. The immune system itself has evolved over billions of years and does many jobs far better than our modern ‘symptom relief’ drug culture ever can.”
As for cancer, my mum’s GP’s own phrase was “LDN is anecdotally reported to shrink tumours”, which of course, on a personal level, would have been good enough for us.
But is “anecdotally reported to shrink tumours” actually a reasonable standard to generally deny to terminal patients asking for it, and who have literally no other option?
Whatever your views on LDN, or any other specific treatments, what are the ethics of making Doctors the agents of refusal to terminally ill patients while making such positive statements about the drug they are refusing? Is that why their hands shoot up into the air?
As the Lords consider the issues, they may correctly observe that if patients’ witness evidence of doctors’ behaviour, as well as their descriptions of the effects of drugs, are altogether downgraded to the level of anecdote, and therefore treated as not evidence at all, that would explain why so many bodies claim the lack of it.
As well as raising the question: if there isn’t ever any evidence from patients, but only ever anecdotes, whose interests does that serve?
Reader Comments
Comments posted up to the 26th of December 2014, can be read here, and are also copied below:
Nick – 6 December 2014 at 08:58
A wonderful, articulate and thought-provoking piece. In particular it must be right that individual testimony can’t be written off as anecdotal. A single example in medicine can – and usually should – be treated with huge circumspection because it may well be atypical, or may prompt false confusions about causality. But the two examples of GPs being fearful of the law must be taken seriously. It should be said such cases are uncommon – there is huge off-label prescribing, especially to children (and indeed to cancer patients). But in any case the Medical Innovation Bill wouldn’t solve the unprofessionalism of these two doctors who seem to have behaved in a way that is wholly unacceptable. Nor would it solve what they seemed to think was a legal problem. On the contrary it would likely lead to a whole new range of uncertainties because well-establish principles of common law (such as the Bolam test) would be redundant. Surely the point is this: if some doctors are ignorant of the existing law (which gives clinicians protection for any treatment that other doctors would agree is reasonable) then they need to be better informed. We shouldn’t invoke primary legislation because some GPs get nervous and ratty! Thanks again for a fascinating piece.
unlike say a medical outcome – on the other hand
JLC – 6 December 2014 at 15:10
Thank you for highlighting the problem. However many great inventions came through serendipity. Serendipity is only possible on the back of innovation. The Saatchi Bill underlines what already exists (true), but may just shake up the system and allow Drs to feel free to innovate which clearly they do not at the moment. The health and safety culture and litigation culture has taken over and if anything the Saatchi Bill is to reverse this unfortunate situation. The clamp down on ‘off label’ prescribing does cause concern to the medical profession, sadly. The Chief Executive of the health board mentioned in this article has MS himself, took the matter further and sent out a questionnaire to all GP practices in the area asking them whether they would prescribe LDN. None would for reasons outlined in this article. Fear of off label prescribing is very real.
AngelGarden – 7 December 2014 at 07:30
Thanks for your lovely comments about my piece; which actually go to show that disagreement can be fun!
If as you say it’s not actually a legal problem, but these three docs mentioned in the piece (at least) think it is, while the anti-Bill campaigners stress there’s absolutely no evidence of that, then that all sounds like trying to plait fog.
Meanwhile, Jane’s info refers to many other doctors apparently avoiding prescribing for the same reasons, ie. legal comeback, so that does point to a massive communication problem, because if it’s not true, where are they getting that misinformation from?
Liam White – 25 December 2014 at 16:52
Thanks for a very insightful piece. I’m surprised you think LND is non toxic as British national formulary tells GP to order liver function tests before prescribing and not to prescribe to patients with any renal or hepatic impairment, so there is some toxicity issue. First contributor is spot on about primary legislation absolutely not being the way to deal with this. It’s a professional cultural issue: “First, do no harm.”
I expect the lawyer you refer to will be from a medical defence organisation and therefore also a doctor. Dying patients can take whatever they like and this is not usually a problem unless it can interfere with treatment which may work. In the case of motor neurone disease patient, it may have been reasonable to worry about compromising their remaining health. Even if the patient’s consent is clear, the slightest risk of harm would compel the doctor not to prescribe. That is not really about the Bolam test, and junking it for any Saatchi Bill imaginable would certainly do more harm than good.
JLC – 26 December 2014 at 03:33
Naltrexone has been proven to be non-toxic and I will happily share the studies supporting this. To address your point about the advice to perform liver function tests before and during NTX treatment, this is based on the ‘potential’ hepatotoxicity prescribing 50mg doses and higher (not LDN which this article refers to which is doses at 4.5mg and lower). However, I think it’s essential for GPs to be monitoring patients when prescribing any medication. To not do this would show irresponsibility. Most when taking any medication approved by NICE do have regular blood tests. Some end up with serious consequences to these toxic drugs such as kidney impairment after only 6 months use. So yes, I agree ‘First Do No Harm’ and this is where LDN comes into play.
You might find the study Naltrexone: report of lack of hepatotoxicity in acute viral hepatitis, with a review of the literature to be of interest which includes where it states:-
During the past decade, NTX has been shown to be safe and effective in the treatment of pruritus associated with severe jaundice caused by severe and sometimes life-threatening cirrhosis and other liver diseases. Its safety, even in these extreme conditions, is particularly reassuring.
http://www.ncbi.nlm.nih.gov/pubmed/?term=15203443
Speaking of hepatotoxicity, a study was carried out – hepatotoxicity of NTX in the treatment of alcoholism. Findings further support that NTX is not hepatotoxic at the recommended daily dose (50mg) and may be beneficial for patients with elevated liver enzymes. After the 12-week treatment, levels of the hepatic enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) did not show any elevation, except in one subject, and the results strongly support that NTX did not induce abnormalities in liver function tests or elevate the liver enzymes. Instead, a statistical significance of decreasing levels of ALT and AST in the liver was shown throughout the study.
http://www.ncbi.nlm.nih.gov/pubmed/?term=16839858
And here’s another – Lack of hepatotoxicity with Naltrexone treatment – where the study monitored liver transaminase levels, in ten Huntingdons Disease (HD) patients receiving daily doses, between 50 mg/day and 300 mg/day, of naltrexone for periods of 10 to 36 months concluding chronic administration of naltrexone in doses up to 300 mg/day for periods up to 36 months does not significantly change hepatic function, as measured by SGOT and SGPT levels.
http://www.ncbi.nlm.nih.gov/pubmed/?term=7983232
I was quite surprised to see a post here saying “I’m surprised you think LND (I know you meant LDN) is non toxic. Well it is, nobody is thinking this and there’s a couple of links to studies showing this (there’s many more). I trust this alleviates any fears about the prescribing of LDN as many patients are taking it who have compromised livers showing extremely successful lab reports proving the safety and efficacy of LDN.
It’s no wonder many Drs leave their profession after working in the NHS with so many restrictions placed on them. Only being allowed to prescribe toxic medications where many have ended up with life threatening diseases makes me wonder how some in the medical profession can sleep at night. Support medical innovation / Saatchi Bill.
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