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
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.
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?
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.
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.
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.
ReplyDeleteunlike say a medical outcome - on the other hand
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.
DeleteThanks for your lovely comments about my piece; which actually go to show that disagreement can be fun!
DeleteIf 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?
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."
ReplyDeleteI 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.
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.
ReplyDeleteYou 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.