Something Happened!

"I'm feeling strange, she said". I glanced across from the road in front. She looked agitated, and her voice became slurred, as if slightly drunk. I froze for a second and then asked her to smile for me whilst stopping the car. I put on the hazard lights and looked at her carefully."Lift your arms and close your eyes", I said. She did it. I got out of the car and went around to her door and opened it. She then said in a normal voice, " my arm's a bit numb and my leg too". I asked her to smile again, stick her tongue out and raise and lower her arms. She complied immediately. I got her out of the car and helped her stand. "Walk", I said, and slowly she walked at my side and we turned and went back to the car. "It's on the other side now and my cheek's tingling". "It's changed sides!" I said. She concurred; it had.

I was gripped by fear. The signs although small and transient were nonetheless bad. I did not want to admit it, but the woman I loved was possibly having a stroke! I needed to act and fast, just in case it progressed. I got her into the car went to the driver's side, got in and turned around, heading, not without some trepidation to that hospital, the scene of our past trials at the hand of the NHS. My car screamed it's way through the Friday afternoon traffic, headlights on to try to clear a path. It was 4.30 pm and busy. It was also August. The new intake of FY1's would be there to greet me no doubt, anxious to contradict the view that they were presiding over a another 'killing season' as August is aptly named in A&E, and that's just by the doctors.

I made remarkable time, all the time hoping I would wake up and this would be just a bad dream. It wasn't of course, it was real life. I parked illegally by the Ambulance bay and helped J', who was not very ill just very scared, into Reception. Taking grasp of the situation, I shouted that my wife was probably having a stroke and to help me. That worked. They got her onto a trolley straight away and pushed it into the Department and then left us! And so the waiting began.

I stood at the side of the trolley, holding her hand and trying to assure her that she would be fine. She still had some 'tingling' sensation in her right cheek and was extremely frightened, but little was happening and the floor was filling with patients on trolleys. It was more than an hour before we were taken to a cubicle and a nurse (well a nursing assistant) said she needed some 'bloods'. As she said J' may need some IV medication she would insert a cannula. I was about to protest but J' stopped me. I do not believe in invasive procedures 'just in case' and there was no way she was going to be infused with anything without considerable evidence of need, but I held my tongue. She was also completely useless at the task, took many tries and caused considerable bruising in the antecubital fossa.

A Doctor eventually showed up after some two hours and conducted tests; the usual smile, open/close your eyes, lift your arms etc. He also tried the resistance tests (pushing/pulling against his hands). He then departed and shortly after the ECG/EEG trolley was wheeled in and a nurse applied the twelve leads and conducted the test. I don't have too much knowledge of this procedure, but sufficient to see there was no atrial fibrillation, which was a relief. She went away again saying that a doctor would come and interpret the test results, but before this could occur they came to take J' for a head CT scan. I went with her; they sure as hell were not going to separate us this time! She was not in there long and when I asked the nurse she had no idea of the dose rate of radiation she had received. But, I knew it to be 2 mSv or about 20 chest X-rays and because it's the brain we're scanning that's a lot. Again we were told that a Doctor would be along to give us the results.

Well, we waited and waited. They had left the charts and I checked for obvious problems. Her BP and pulse were very high and blood sugar too at 8.5 mmol/L, although the stress of it all and the natural protective measures of the human body would have been responsible for this I was certain, although even so 190/95 seemed high for someone who regularly records 120/70. Then, over three hours into the event we saw a Registrar who basically said that nothing on the test showed any abnormalities and he went through the routine tests again. I said I thought it was time to go as J' was becoming agitated and the situation was becoming more harmful than productive. As the 'event' had crossed the mid line (changed sides) I was pretty certain it was not a stroke or TIA (trans ischemic attack) and voiced this opinion. He agreed, although was somewhat guarded but did think J' would be discharged quite soon, to my care.

As it was August I suspected he had just been 'made up' to this position and was not really confident in his decisions and he went away saying he would return soon. He didn't. Yet another nurse arrived to say J' was being taken to the Stroke Unit on the other side of town! And of course she had to go by Ambulance, not with me, unless I abandoned my car. I reminded her to remove the cannula which she did reluctantly and I said I would follow the Ambulance. I talked with driver while he waited for his partner to collect the paperwork. He told me to follow him out and he would ensure we did not get separated, which he truly did, slowing down if I got caught at traffic lights. It was nonetheless a nightmare, with me anxious and extremely stressed at the separation from J' as I did not trust the NHS or any Doctor I had seen thus far. I was also bemused as to what had occurred and hated once more the prospect of being caught up in the 'machine' that passes for Medicine today.

We arrived twenty minutes later and J' walked in accompanied by me and the driver. After a couple of minutes I was then allowed to be with her on the ward. They had given her a bed! BP and Pulse were taken together with blood glucose and oxygen levels. If anything BP had increased, to 201/95 and I was a beginning to feel the place we were in was more to blame for this than anything else. I wanted us to leave, but I also wanted to be sure that in so doing I was not putting J' in jeopardy.

 After an hour or so a nurse appeared who seemed to be in charge. She had decided to do a 'swallowing test' which apparently gives some indication of Stroke/TIA if the patient cannot swallow sips of water from a spoon. As the nurse was holding the spoon J' gagged a bit, which I found unsurprising and as she had already taken sips of water from a cup earlier, (which apparently she should not have done) I thought it was useless as a test. She also apologised for the delay in seeing anyone (but her) due to an emergency. Ah well, I thought that's triage for you.

By this time it was well after 10 pm and we were some five and a half hours into the event. And here's me thinking the first three hours were critical in stroke diagnosis! We sat there for another hour, with a sense of dread coming over both of us. J' was all for going anyway by 11.30 and said she felt fine in every way and just wanted to escape the clutches of the NHS which by this time we felt were just trying to cover their collective arse's. Just as we were about to do precisely that, a Doctor arrived.

He was quite affable and at least not patronising, recognising that we were not average punters and at least gave us some respect. He went through all the procedure again and also allowed J' to sip and then gulp water from a cup, which she did without problems. He said he thought an MRI would be useful together with an ultra sound of the neck to check for plaque in the arteries. He also said it would not be possible for this to occur now as the facility was not on line. Whether this was because it was the weekend or for some other reason he did not allude to, but after conducting a 'stress test' comprising J' blowing a stiff sheet of paper until it bent, for a whole minute, he decided he would discharge her to my care. Not before however, she was coerced into taking 300 Mg's of soluble aspirin and a promise that she would continue with this regimen until an appointment could be made for the tests by 'phoning them on Monday of the following week.

I discussed with him the likely cause of the event and that it did not seem to fit into the pattern of a stroke or TIA and he at least admitted that he was baffled. But he said until he had seen more test results he would not pass judgement and for safety's sake we should keep up the aspirin protocol and be prepared for other interventions such as Clopidgrel. Not on your life mate, I thought, aspirin, enteric coated at 75 Mg's maybe, but not that awful stuff! But at least we were able to escape, clutching a sheet of paper with advice about TIA's we exited the building as fast as possible, in case they changed their mind! It was gone midnight and we had been in their care for more than seven hours and still no real diagnosis!

We reached the car and I opened the door. I held J' in my arms before she could take her seat, grateful that she was still with me. It was a long moment before I let her go; I never really wanted to let her go ever again but I did and we traversed our way to the entrance and sped off back to the 'hovel' both emotional but relieved to have escaped, relatively unscathed from the NHS and the events of the day.

At home we were both agitated and bemused. We had no idea of what had occurred or its reason. I know Diabetics are more prone to any sort of stroke than the normoglycemic community but all other factors were not present. She maintains good control of her diabetes's with HbA1c of the low 6%. She has excellent low BP to the tune of 120-130/70-80. She does not smoke, takes regular exercise and her clotting factor was low normal. If we ignore the 'drivel' about cholesterol (her non-fasting total is 6.5mmol/l total lipoprotien) but most scientists know that in a women this is viewed as 'protective' rather than indicative of any danger. So what may have caused this? Obviously the Neurologist did not know because he said as much. It would be rare, even if there was some plaque formation that it would cause a bilateral blockage almost simultaneously, but that would have to be determined for certain by MRA/MRI. So we would have to wait for this determination before reaching any conclusion. And of course that would not be until Monday.

We spent a somewhat agitated weekend, with me watching her like a hawk, not letting her drive and giving her a daily dose of enteric coated 75 mg aspirin, just in case there was any possible problem, to be reviewed in the light of further tests. Aspirin is not a drug I like and cannot take myself due to a past ulcer, but J' has a very strong stomach and never even gets heartburn, ever, so I was confident that a few days intake would likely do little harm. Long term use was not something I wanted to contemplate (yet). I did increase the dose of Omega 3 capsules to 2.10 gms (in 3.30gms of capsules) as this is a fairly benign anticoagulant,( from its previous 1.40 gms), although I knew it's effect would take some time to be realised. I also took her BP and pulse regularly and as sure as predicted, it returned to usual levels within 24 hours of the event, in fact by Saturday night it was 118/71 and the pulse was 76!

Monday came and I 'phoned up about the appointment the Neurologist said would be made first thing. They hadn't even heard of us! They promised to call back. They didn't. At 12 noon I rang back once more and was told that it was now too late for that day but 11.30 Tuesday was the time they had arranged. So that was another day wasted, and so much for the urgency of the tests the Doctor had said were essential, and had to be undertaken that day!

After another fitful night, whilst we were preparing for the day, we then had a call from the Hospital. They had a spot available as soon as possible, could we come in straight away? Obviously we agreed, fools that we were. We got there and after another bout of form filling were ushered in to see the duty Neurologist Dr. W. Without an doubt whatsoever he was dick! Uninterested, remote, rarely looking at the patient, he said very little, asking a few questions and making a very short examination. Just the pulse, wrist and carotid and the usual tests for stroke. He conveyed no view when I asked him about the symptoms crossing the mid line just stared at his screen. He did say J' should have an immediate MRI of the brain together with an MRA with contrast dye, of the neck, no doubt to check for any plaque in the Carotid.

He then told his female assistant ( a trainee) to arrange this and we were dismissed. We sat outside awaiting the news and the young woman came and told us she could not arrange it until 1 pm, which was some two hours away! Not enough time to go home and then struggle back across town and find a space again in the immensely expensive car park, which was half a mile from the unit. She then said she would need to install a cannula for the dye infusion, so we would need to come back to the unit for this before we went to the imaging unit for the MRI/MRA.Why they had not already arranged a test  when it was obvious that it was a need, and the entire reason for our visit, escapes me, but obviously our time was of no matter and theirs at a premium, despite the fact that they would be hard pressed to arrange an orgy in a brothel.

So we went into the Hospital and tried to obtain some food and drink. Well there was coffee, of a sort. The food was all 'junk food', all very high in carbohydrates and totally unsuitable for a diabetic, and frankly it was all highly processed rubbish. We took a further walk through the grounds back to the unit and the trainee then came to insert the cannula for the dye infusion. She seemed different now the boss wasn't around and told me she had researched the dye side effects whilst we were away and attempted to assure us both that it was relatively benign. I discussed her training whilst she was at work on the antecubital fossa. She had just completed FY2 and was now a GP trainee and knew a number of my friends in research and emergency medicine. She was also excellent at inserting cannula's, with confidence, gentleness and expertise that produced no pain or bruising. So we trotted off to the MRI facility half a mile away.

I was stunned when I saw it. It was a brand new building, in the grounds and provided on a 'contract' basis by a private provider; more cash for the private sector! Anyway, after a minor altercation with the 'prick', who drives the machine, J' went away to return fifteen minutes later, sans cannula and in no distress from the dye infusion which said she hadn't felt. We had been told we would get a 'phone call later with the results after they had been evaluated by Dr. W. In fact his secretary rang about 5 pm to tell us that everything was normal and that nothing at all had been found! I'm sure the sod's always get their underlings to provide this sort of information just so you can't ask questions, because we both had many, but for lack of anything else we could do, we would have to wait for the letter they would send.

We had a long wait. After four weeks I rang the unit and spoke to said secretary who informed me that we were not getting a letter but one had been dispatched to the GP some weeks ago. Upon further probing I found they had sent this to our GP of five years before and not to the current one, despite the fact I had filled forms in with the correct information; twice! She did say she would ask permission of Dr. W  for us to receive a copy. I was almost choking with anger by then. "You mean that we are not allowed to see what has been determined about my partners event, but you, our GP and anyone with the access password can?". I said I felt it both insulting and patronising that such should be the case and I would complain in the strongest terms if this was not rectified. She promised to do what she could and I left it there. I explained it to J' who responded with a few expletives,somewhat worse than any in this post.

We did get that copy after another week, and it simply said that J' was healthy without any evidence at all of any abnormalities and, curiously, 'the rest of her history is non contributory'. What! The trauma surgery your colleagues botched, the diabetes they missed, the keto-acidosis, the fact she cannot take vigorous exercise, because the hemiarthroplasty starts to hurt after half a mile, and the chances of revision surgery succeeding or her surviving it, recede with every passing year!

It's also interesting that at no time was J' asked to give any informed consent, written or verbal, for any of the investigations, nor was anything ever explained in any detail until I pressed those involved to do so, and was able to demonstrate knowledge and qualification. Even then, they spoke over J' to me, or directly at me. Bunch of patronising misogynist prats. I really shudder when I think what may have occurred had I not been there to fight her corner. And what is my take on the event? I do not really know, although I suspect it may be microscopic particles of debris (plastic/bone/metal) from the hip implant momentarily lodging in the brain. We are at the stage when the joint will be producing quite lot. Active people can wear them out in five years. J's active and that's next June.

This, dear patient reader is the reason why my blogging has been somewhat curtailed of late. These events have had a profound effect on us both, highlighting the fact that our grasp on life is at best tenuous. But that can be said of us all. But, wherever possible we should all keep away from hospitals; they're full of sick people and not all of them are patients.

Obama's Gift To Pharma.

Once the 'individual mandate' takes effect in the US 'Pharma' will have more patients to sell it's dubious health care products to. About 23 million more to be precise, and whilst I applaud the concept of Heath care for all, do wonder what they will be letting themselves in for.

With Worldwide drug sales having already topped the 1 trillion dollar mark it seems a strange commentary on the success of the sector, that it is also the largest recipient of fines and censure for it's outrageous behaviour to it's customers, the patients, by the manipulation of data, bribery and corruption, and  'off-label' promotion of its products. Some of these would be termed 'technical breaches' and whilst some practitioners in medicine, will use drugs that are not 'approved' for the treatment of a particular disease or condition, it is illegal for the makers to actually promote the use in such a manner. Drugs are licenced for particular conditions and if used for others they need further approval for any secondary use before they can be included in a 'guideline' for treatment. I don't particularly support these licensing arrangements excepting that I approve of any measure that attempts to keep this self serving and immensely greedy sector in check.

Looking then to the many appalling incidents that have brought 'Pharma' to ordure, the recent record fine of $3billion to GlaxoSmithKline was the landmark to judge others by, although no-ones in jail, least of all CEO Andrew Witty. His reward was a knighthood from one of the 'Dave's' that govern the UK (rather badly). Witty of course absolves himself by denying any participation and that it all happened in the past, when in fact much of the time line disproves this.

Moving right along then we come to Pfizer who scored the (then) highest settlement in history, of £2.3 billion for 'off label' marketing of Bextra, a Cox-2 inhibitor (as was Vioxx) which caused severe heart problems for those who took it ease the pain of arthritis. In fact the mechanism of Cox-2 inhibition is fraught with problems for the heart and is yet another 'blind alley' entered by 'Pharma' in the pursuit of profit. The rule of unintended consequences is one that is often ignored: stop one element of humans' biochemical machinery and you are likely to bring about a disaster in another.

Geodon an antiphyschotic, was also used off label for the treatment of bi-polar disorder in children! I will have to repeat that; bi-polar disorder in children! Apparently, manic depression, a very rare but quite awful disorder of adulthood symbolised by mood swings of euphoria to abject misery has now 'morphed' into....bi-polar disorder. And now 'little tommy' who keeps having a tantrum when he doesn't get his own way and sulks, then five minutes later is running and screaming in the garden (yard) with his friends, is suffering from bi-polar disorder. My diagnosis would be that he is just being the pain in the arse (ass) that many children are, and if you stop filling him full of glucose laden food and drink he wouldn't be so hyperactive! But get real, he does not need any heavy duty antiphyscotic, nor except in extreme cases does any child or indeed anyone, he just needs his parents to start acting like...err, parents!

Zyvox was also promoted as a much more effective antibiotic than was the forty year old generic vancomycin, when in fact it wasn't; Pfizer had promoted it on the back of highly flawed (fudged?) evidence, simply to get paid for a much more expensive product. And of course Lyrica tanked when it failed to have any more effect than the placebo for the extension of use Pfizer had tried for.

Johnson and Johnson ("a family company") failed to live up to it's friendly (sic) image by the marketing of Risperdal, an antiphsychotic drug for other purposes. Natrecor, a heart drug alleged to improve patients breathing who were in heart failure, was actually less effective than placebo's, but it took ten years (of profit) before J&J were caught out. I could go on about J&J's sin's but this post would get too long. You can read all about the top eleven settlements at Fierce Pharma ,if you have the time. And I haven't even touched upon their medical device's such as metal-on-metal hip joints.

'The elephant in the room' (your doctors surgery), is the triumph of form over substance. Drugs are now prescribed on the basis of what is new and in patent, not that which is most efficacious, because certainly if you examine most that are (in patent) with any degree of scientific scrutiny, it will be seen that many are little different from the drug you may have been given twenty or even forty years ago. The irony being that the older drugs are cheap, or didn't have a patent ever, or they were only patented in the country of origin and thus made in other countries, very cheaply. The most obvious of these is penicillin which Ernst Chain wanted to patent (the production method that is) but his colleagues prevented it because of the importance it represented to health care. Similarly Lilly famously tried to patent the production of insulin but Banting's team sold it to The University Of Toronto for 50 cents.

These then, were examples of the moral integrity displayed by those in medical research, in our recent past, when the landscape of drugs was changed forever by the inventions of chemists and biochemists, immediately prior to and after the 2nd World War. We had sulfonamides, penicillin's, Salks' vaccine for polio (which he refused to patent), along with many extracts of the dyes perfected to bring colour to clothing, that spawned much of today's drugs including diuretics, antihypertensives and some of the oral hypoglycemics. Each was produced relatively cheaply, well by today's prices anyway, but even then there was rancour about the margins made. With the newer 'blockbuster' (over $1 billion sales) the margins are often in the order of 1000 to 2500%!

Diphenhydramine

What needs to be understood today, is that the capabilities of molecular manipulation have expanded enormously and small adjustments to a drugs structure can often yield a new one without perhaps, changing it's design use. A better mousetrap; well this has often been the reason proffered but more likely is the excuse to charge more and market the resultant drug as a 'breakthrough' and by gist of clever and often ruthless selling techniques. Some of these are the reason for the huge fines and ordure heaped upon the industry illustrated in this post. But the rewards are so huge that a $billion or few is 'chicken feed', in the face of the profits to be made, fines then are reduced to a simple 'operating cost'.

Thus we have SSRI's derived from the older Antihistamines such as Diphenhydramine and Chlorpheniramine, when frankly these older drugs are often more effective (although sedating) than are Selective Serotonin Re-uptake Inhibitors, but they are off patent and cheap so you would be hard pressed to charge a fortune for them as you could for Prozac (at the time) or indeed any drug that is targeted at a 'niche' disease or one that cannot be the subject of a 'patent'.

Prozac

 What 'Pharma' does and does very effectively, is to manipulate the market by the invention of a disease(s) that doesn't have any effect on anyone's real life but predicts the progress if unchecked, of a downward spiral of ill health and early death because of the presence of 'surrogate' markers of this disease, the most famous of which is 'high cholesterol'. The 'invention' of this so called disease, has probably been the most lucrative market for 'Pharma' and heralded the rise of the sector to the same levels as those of energy and banking. Quite beautifully, it depends entirely on the interpretation of a complicated set of figures that mark the various levels of lipoprotiens in the blood of humans. Persuading the somewhat gullible or even complicit members of the Politburo of Health in a given country that a particular set of numbers is healthy and another isn't, is the basis of the disease's progression. Moving these figures ever downwards also opens up the possibility of more and more members of a cohort that then become included in the 'at risk' population.

So now instead of being in the business of making drugs that can really save lives, 'Pharma' now is back to it's beginnings, selling 'snake oil' to punters out of the back of a covered waggon. And worst of all they don't have to convince the bulk of the populace (although in the US they can advertise directly) they just have to convince, coerce, bribe or even force (by the use of guidelines) the Doctor to write the scrip. Enrolling the Doctor onto the payroll metaphorically or even literally on many occasions, makes it both more complicated and simple at the same time. You have less people to convince to carry your message to the customer, but you also have to overcome the (once) innate scepticism of a relatively highly educated, sort of 'semi-scientist'. So in the UK at least, you start feeding money into research and medical education and promote the use of guidelines such that the younger cohort of students never even hear of the 'older' treatments and drugs, until even the generic makers stop producing them. Eventually you will have an entirely new generation of compliant GP's and Medical Practitioners carrying the message that you can provide a drug for every condition, ailment and disease and the plan will be complete. And of course your future profits assured.

We are staring into the abyss of a dystopian world where politicians, aided and abetted by the distortion of Capitalism that now passes for 'free enterprise' (but isn't) follows the trends set by the Industry that our taxes are funding. Patents are the antithesis of enterprise as are the monopolies they spawn. Prescriptions are the opposite of the 'buyer beware' culture that we utilise very day to prevent ourselves from falling prey to the many that would steal our wealth. If we had to work out our own destiny instead of being reliant on this distorted sales paradigm of industrial medicine it might make us more aware of the dangers we readily perceive when purchasing a used car. Ending 'prescription only' medicine may seem like a step too far but if we are really going to embrace 'free enterpise' then perhaps it should be taken to its literal conclusion. Let's then move to real market economy instead of the 'faux' one we have today.

If Circle can really live in the real world instead of the 'rigged' private enterprise market that sees them losing money except at Queen's Hospital in Nottingham, because they are crap at running other locations, where they haven't got a contract that ensures them all the easy jobs, then let it be so. Inject some real competition into the system and then we'll see just how good these providers like Serco, Crapita, Carrilion, and Virgin really are. Instead of handing them contracts on a plate backed by taxpayer gold if it all goes t*t's up. Give Capital free reign and let them see if they can survive without being bankrolled by the State. Maybe then all these recipients of our largess might actually earn their keep, or not?

As for 'Pharma', well take their patent rights away, let competition rip and then see if they can 'cut it' in the real world. And if they cause harm let the architects of that harm be prosecuted for that harm and spend some jail time. Maybe 320 lb Marvin in cell block H with his tattoo's and general penchant for recreational sodomy might discourage them from repeating the offence.

Turning Gold into Lead.

The 'gold standard' of scientific study for many years has been the Randomised Control Trial (RCT), preferably 'double blinded', which means that none of the participants, doctors or the cohort, have any idea of whether they are receiving the drug or the placebo. Austin Bradford Hill is credited often with it's invention, but it had already been used in crop trials as well as psychology, before his ground breaking research into tuberculosis and the association of lung cancer with smoking. However, it has always been that which is held up as being the proof positive that a drug, protocol or intervention is better than the placebo and is safe.

I have often, in my posts pointed this out and, frequently been highly critical of trials that do not utilise this and resort to epidemiological or observational evidence as 'proof' of hypothesis, often calling them 'wibble'.  I have not changed this view, but I have distinct reservations about  most trials, if they emanate from 'Big Pharma' to support the approval of some new drug, device or protocol. I say that because 'pharma' has corrupted the very heartland of science, and caused the prescribers of their highly flawed products to become complicit in this calumny of the foundation of  'evidence based medicine'. In fact those words themselves have been used to conceal tracts of evidence that points without doubt to the fact that much of their output is considerably more toxic than they would have us believe, and is no more useful to patients than a placebo for many, if not most.

The main problem lies with the incredible rise and rise of Pharma companies since the 1970's when the constant seeking of 'blockbuster' drugs came about. In 2011 the total sales of the top 6 Pharma Co's amounted to $253.30 billion dollars, which is truly astounding. Aided and abetted by the captive audience of the prescribing team of their sales departments, Doctors. It is so lucrative, so incredibly valuable that virtually nothing will stand in the way of a 'pharma' co, in the pursuit of another Statin, Anti-hypertensive, Hypoglycemic, or better still Anti-Psychopathic or Anti-depressant (although these are usually interchangeable).

So much money is involved that they cannot be allowed to fail in the endeavour of bringing a new drug to market, even if the evidence that it has any efficacy is minimal or that it presents danger to the patient cohort for whom it's targeted. Ways and means will be found to ensure that data is concealed, patients re-allocated, P scores made to look more significant (by adding up lots of insignificant ones), removing completely any sub trial (or even a whole trial) that did not reach significant levels of proof. Generally 'fudging' the exercise to ensure you can convince the FDA, EMA, MHRA and NICE, that the drug you are offering is better than a placebo and does not present a danger; well not a lot of danger, to patients.Or better still a drug that does not present a danger to people that are not (yet) patients because 'disease mongering' is one of the classic methods of creating a lifestyle drug such as 'statins' that will ensure you have a ready pool of frightened and gullible people to the sell idea to, that they may have a chronic ailment that could kill them at some distant point in the future, if they don't take your benign (but essential) medication that will make them live potentially forever!

All you have to do to achieve 'mass medicalisation' of the populace, is to instill in their Doctors the belief that if you construct guidelines for 'surrogate markers' for possible ailments, they will become your surrogate indoctrinator, thus allowing you to market a a drug that circumvents the need for lifestyle adjustments that are frankly tiresome and often ineffective (usually because they are wrong). You then set about the task of hoodwinking the somewhat servile and often ignorant doctor cohort (biochemistry is not their speciality) by getting your drug approved by the authorities who are always ready to disport their desire to interfere in the lives of the proletariat, if they can prove by so doing they are actually saving people from themselves and thus reducing future costs of medical care for the State (in the case of the NHS). You do this by a process of 'ghost writing' studies, financing conferences with itineraries that suggest you wish to address an important societal problem that we never knew we had, for cohorts that are minuscule but could be potentially huge if you can manage to massage the data for such as being potentially an epidemic. You outsource the trial to one of the newer specialists, preferably in a poor country, populate the conference circuit with eminent lecturers, who have generous honorariums, shares, and even patents for some 'isomer' of a current drug you can make into yet another 'blockbuster'.

In recent years these 'areas' in need of special attention, have been cholesterol, osteoporosis, hypertension, pre-diabetes and diabetes, obesity, cervical cancer, manic depression (now bi-polar disorder), depression etc. which occasionally would have prompted an intervention in extreme cases by a doctor and drugs. These drugs would have been time tested, well known and for which (probably) there would have been no trials as such, but doctors would have been using them for most of their lives and they had the evidence of the patient in front of them, as being 'better', even cured due to your intervention. A lot of the time you simply employed 'watchful waiting' and a lot of the problems resolved, especially if you gave them a sympathetic ear and eliminated some of their worst fears. No more. You have a QOF protocol to serve and the politicians have 'sweetened' the pill for you to swallow by paying you for the dubious pleasure of carrying out their orders.

Now you are diminished to the level of a simple 'cog' in a wheel that is crushing the life out of you and your patients. You are the gatekeeper for treatment with your scrip pad as your sword of righteousness, and your test procedures as your shield of light. You are part of an industry that only needs to sell to you because of your (now) elevated status of the 'pill pusher' you can treat a patient by 'rote' safe in the knowledge that you are following 'guidlines'. You can ignore and dismiss the few that come back and complain about side effects as deluded, mistaken or, best of all, that their problem is symptomatic of the problem they have. Most won't bother because they cannot conceive that you, their Doctor, would do anything harmful. You hand out the latest 'blockbuster' from Pharma because it's the new kid on the block, despite the fact it costs 1000x the price of the old one and if you examined it's structure you would be hard pressed to know the difference because essentially it is the same; they've simply moved the 'hand' (example below,a generic amino acid).

Why is this possible? Because that's all that is needed to take out a patent. And by directing most of the efforts of marketing at Doctors (in the UK) by whatever means, you have a small target audience who hold in the their hands the opportunity to affect thousands. In fact Pharma spends considerably more on this element of their business than any research. They constantly collude with many in Healthcare to move the 'goalposts' of the levels at which people are viewed as 'sick', in the so called 'surrogate markers' of disease. Thus, we can look forward to the level of Low Density Lipoprotein as only being healthy if it's zero, and blood pressure targets of 100/60.

This madness is our future, if the power of Pharma is not curtailed and Doctors not allowed to resume their role of healer, rather than an administrator in the industrial machinery of Medicine. Is it not obvious from the disasters presided over by the Authorities in recent years that these 'blockbuster' drugs can be lethal. Avandia was on the market for eight years before it was withdrawn, but not before GSK had made $billions from it and the bodies had stacked up sufficient for someone to take notice. Plenty of money then to foot the bill for the fines and legal costs involved in settling with aggrieved patients and their families. Actis, Vioxx the list is in fact endless, of drugs that were so called 'blockbusters but proved in the longer term to be toxic.

Over my next few posts I will present the case for the prosecution. But there will not be any such case in any UK court. 'Pharma' is part of all of our lives. It pervades every aspect of Healthcare and has reached a position of such power, that politicians treat extensively with them for their manufacturing plants to be sited in their countries including our own dear leader, the 'posh' twait David Cameron, who was so in love with GSK that he endowed the CEO David Witty, with a Knighthood in January, (along with some of my money) to encourage him to expand operations in the UK.

So wake up and smell the coffee! Costs will escalate no matter what fiscal austerity is applied to the NHS, because 'Pharma' needs our money, they don't care whether it comes from 'Obamacare' the NHS, Medicare, or the bloated Insurance sector so long as it is there. That is why most of the 'gold' of medical science has become lead.

Apologies for my absence from the blog over recent weeks. Rumours of my demise were exaggerated and I hope to post with renewed vigour and the rapier like wit I am renowned for (sic).  I have been ill but not terminally so, I hope!  And, the harsh reality of the current financial climate has also meant I have had to 'run' a little faster than is my want, to survive. I keep telling myself that the original objective was to traverse the swamp, but when you're up to your arse (ass) in alligators you do tend to react, rather than follow the 'plan'.

An 'Ambiguity of Evidence'.

So says Dr. Edward Stefanek with regards to Cancer Screening in an article in Medscape Today. He cites the 'summoning' of women for mammography, contrasting with the 'informed choice' paradigm that exists for men with possible prostrate cancer. He suggests too that this is paternalistic, I would say more likely misogynistic as well, because men are viewed as being participants in some sort of  'club' by simple virtue of their sex, when it comes to honesty in health care. In fact the first rule of misogyny (just like 'fight club') is that we don't talk about misogyny.

Well, I for one don't want to belong to any such club, fraternity or organisation. I do not want to labelled as a feminist either, because I do not wish to 'steal' the term from women. I want to be known as an equal, and one who is just as vulnerable, fallible and more importantly human as is any woman. I am not strident (except in this view) aggressive or demanding of any submission (from women) and feel some men are 'spoiling' it for the rest of us, and the greatest of these are the those who lurk in Medicine, and within that cohort those who continually ram home the message that 'screening saves lives'. Well, patently it does not. It may facilitate an intervention that may do so, but screening per se cannot save any life.

Screening for all cancers is constantly on the rise, despite the fact of the paucity of evidence that exists to support it's continued promotion by the NHS. Medscape also featured Carole Schroeder  who has an interesting blog that provides good information for men about prostrate cancer, but the main thread is that for far too long, women in general (and occasionally men) have been subjected to a constant tirade that they are taking "unacceptable" risks with their health unless they submit to screening. Mammography leads the way despite the fact that recent studies have clearly shown that it is not effective for most and can be catastrophic for some as I detailed in a previous post. There is now a groundswell of opinion rising to ensure that all those who participate are fully informed of the risks, benefits and harms of the process, instead of the current paradigm of inflating the the risks of breast cancer and concealing the harms of mammography. The the BMJ highlighted this last July and I wrote about the innate misogyny displayed in many of the testing regimes, aimed at women, only recently.

A recent development however, is the call for younger women to be 'screened' for cervical cancer, which to be frank is bordering on the dangerous, but when a young Nottingham woman was diagnosed with cervical cancer the pressure was applied both at local and National level for this cohort to be screened. This is despite the fact that only ten deaths from this form of cancer in 20-24 year olds was recorded in the whole of England and Wales in 1988-1989 and it has subsequently 'fallen of a cliff in mortality terms down to 3.7 deaths per 100,000 by the turn of the century (overall mortality). So despite the fact that Natalie Carney did actually have cancer, which is appalling, should we then create a whole new subset of tested women because of one isolated case? Women in this age group often have abnormal cells but it is well known that virtually all of these regress spontaneously without intervention, which is largely why young women are not screened. In fact most screened abnormalities are either benign or regress generally but 'over-diagnosis', just as in mammography, dominates cervical screening. But there is a bigger issue, as always and that is Coercion.

Persuasive tactics predominate all cancer screening testing. The NHS and it's GP's in particular values it out of any proportion to the benefits, but it is a political imperative, maybe to show that they care (sic). 'List and chase' was the tactic employed in the 90's along with 'hit that target', all to encourage GP's to recruit women to the Cytology Screening Programme so they could get their target payments. Yes, they get paid substantial sums for achieving an 80% uptake of testing in the 25 to 64 yr old practise cohort. In fact until payments were commenced uptake was quite low, but once the money was there that all changed. One GP is alleged to have said, "We are afraid of missing our targets, not missing a cancer" (Journal of Medical Ethics 1998;24:151-157). I think that sums up the position quite nicely.

There is little in the way of information provided to women targeted, just exhortations that 'you put your life at risk, by not complying', or ' REMEMBER - regular smears saves lives' and other such coercive statements that are simply not borne out by the evidence. A balanced view is never given and feminine autonomy is usurped by this type of inflammatory rubbish because experts cannot predict the incidence of abnormal smears nor those that will definitely progress to invasive cancers. Quite large numbers of those tested are then subjected interminable waits to find out if there cancer is real and many go on to be treated with surgery or radiation for no useful purpose other than 'being sure'. Those who try to shun the tests are often singled out for bombardment with 'phone calls, text messages and mail shots that are akin to blackmail, foretelling all sorts of dire consequences if they continue to abdicate their responsibility to their partners and families.

Current leaflets explaining the test and likelihood of cervical cancer outrageously inflate the benefits saying that screening is responsible for the drop in the rate of mortality, when it was falling before the testing system got underway and there is no evidence whatsoever that the fall in incidence or mortality was due to screening. Almost 30% of actual cancers occurred in women who had adhered totally to screening guidelines. There were 6231 women diagnosed with cervical cancer between 2007 and 2010, in a population in England of 14.6 million. 44% of those cancers were classed as 'micro-invasive' and were conservatively treated by cone biopsy or loop excision (and of course may not have been true cancers). So that is approximately an incidence of 14.4 per 100,000. Or approximately 8 per 100,000 for those with Stage 1B+ Cancer or worst. At 1 in 3000, you are considerably more likely to to be hit by a meteorite ( I know I didn't believe it, but I did check) so let's get this into some sort of perspective. Of course as you get older the incidence and mortality increases, as will be seen from the graph. That of course is in accord with the aetiology of this cancer which can take many long years to develop. But it still remains quite rare. So does it warrant all the attention, cost and stress to women?

More important however, is the treatment of women as a whole as incapable of making an informed decision about their lives and the ethically unacceptable tactics employed to persuade them to bow to the dubious manipulation of the State. We all are (or should be) autonomous adults and it's completely unethical to attempt to infiltrate any of us with dubious medical opinions, statistics or advice instead of treating us a agents of our own destiny. It is generally women rather than men that are treated in this way and it is generally men who do it. I am ashamed of my gender, especially those called 'Doctor'.

Perhaps the words of Professor Michael Baum, one of my medical hero's may be the best ones to end with. They are here.

The Constant Patient

Loss of Innocence-It Goes On.

I left the saga last with J' having gained control of her Diabetes and progressing to a more 'normal' lifestyle, but of course once the NHS has it's claws into you it never wants to let go. Between us we decided that we did not want to participate in any of their 'educashun' (sic) programmes for Diabetes, nor did we want to return to that hospital for any tests for osteoporosis, or X-rays or indeed for anything. Whilst both of us had a jaundiced view about DXA scans for bone density, on balance we thought it was justifiable to have at least one done to determine whether any such condition really existed. As a consequence we decided to pay for one at another location. So we did.

The results were pretty much as predicted; her hip and spine were slightly less dense than optimal and she was defined as 'osteopenic', which is pretty much what any post-menopausal woman is likely to be, especially in our Vitamin D deprived country with it's aversion to sunlight, love of sunscreens and paranoia about cholesterol. All these, for those who do not know, contribute to the density of the human skeletal structure or rather don't, if you employ any of the above.

A year down the line from the accident we also saw a 'new' Consultant who X-rayed the hip in which the prosthetic 'lurked' to ascertain the extent of any acetebular erosion or protrusion. There wasn't any; well not that could be seen, but frankly a normal X-ray is unlikely to show any until progression was reasonably advanced. It did provide some assurance however and the Consultant was at least honest and didn't treat either of us like children, probably because I talked the 'language' of his profession, in that I utilised medical terminology. In the meantime, we had both changed to a new (for us) GP practise. Because J' was now a registered Diabetic she then began to receive constant entreaties both in the mail and on the 'phone to attend for this test, that vaccination, sundry assessments most of which were largely pointless, or were largely encompassed by our own protocols.


Out of interest, we eventually gave in to a 'diabetic assessment' more out of curiosity than anything else. Of course it was undertaken by a Diabetic Nurse, which presumably did not describe her condition (it was a woman) but her vocation. Looking as she did I was prepared to revise that view because she embodied the 'don't do as I do, but as I say', philosophy in the NHS of appointing those who look sicker than their patients to advise them of the error of their ways. She looked as if she had been a Diabetic herself for many years, bordering on obese, with a florid face and that constant frown, common in those that have little understanding of  what they are doing because they have no idea of why they were doing it,  (I think she probably drowned puppies for a hobby).

She took J's blood pressure (132/65), weighed her, which was the same as it always was (now) took some  bloods for analysis including for a 25(OHD) that I had requested and laid her on the couch and prodded her feet with a short bristle device. As she weighs herself weekly, I take her blood pressure, and often 'tickle' her feet (it makes her jump) it all seemed pretty pointless to be frank, but she did suggest we come along to the 'club' they have for Diabetics, and also a training session where we would have likely had the virtues of low calorie/low fat dieting, extolled in glowing terms and of course be told that there was no need to 'test' constantly (because test strips cost money and the NHS doesn't have any). We declined I'm afraid. She looked crestfallen at this news, but we had seen the pictures on the leaflet and certainly did not want to emulate any of the antics therein portrayed (watching paint dry seemed more attractive).We left then to await the blood test results which were to be available in about 5 days.

Four days later, whilst we were whiling away the time at the 'hovel' counting the cobwebs on the ceiling, the 'phone rang and lo' it was the lead partner in the GP practise wanting to speak with J' about the test results. As we did not have them as yet I found this curious, but not wanting to prejudge the situation, I put her on the 'phone and listened in on the speaker. After praising J's HbA1c result, of 6.3% (the achievement of which he had no hand in, but would be rewarded anyway on the Quality Outcomes Framework) he raised the question of her Cholesterol level of  7mmo/L and suggested she take a statin. J' then asked me to respond to this so I took over the conversation after she gave permission to the Doc' on the 'phone. I pointed out to him that there was no evidence to support such a protocol for any woman, and that it would likely be injurious to her health, along with a few choice references that supported my view, and perhaps he might do a bit more research? At that point he fell back on the "I am only carrying out orders" defence and then told me how the QOF meant he had to do things that he did not always agree with, just to earn a 'crust'. Forcing back a tear, I expressed my heartfelt regret at such appalling treatment meted out by the PCT Commissars and we left it at that, after he promised to let me have a copy of all the test results.

What then are we to make of this? Well, GP's are paid to monitor Diabetics under the QOF protocols and ours had earned 44 points by undertaking the Diabetes examination and recording the findings. This includes achievement of some points from blood pressure, HbA1c and certain levels in the blood of various components, all of which he had no hand in at all! But of course that is never enough. We already had refused the tests for Retinopathy, because our Optician included it in J's annual eye test, the annual flu' vaccination, because it's counterproductive and now of course we had refused statins'. One gets the idea that curing sick people is merely an adjunct to the more important task of fulfilling certain criteria within QOF that invoke payments. Is this what Primary Care has become? Well err... yes.

Diabetics are treated very poorly by the NHS, and outcomes continue to worsen, mainly I believe because the diets, drugs and lifestyle advice is founded upon poor science, dogma and the touching (but wrong) view that 'Pharma' is a benevolent edifice, searching endlessly for cures and life enhancing drugs to make the lot of Diabetics as 'normal' as possible.The truth is that they only want to 'treat' the condition and symptoms with a cocktail of their products, in ever increasing number and volume to make a profit! Virtually all of the evidence that backs their products as efficacious is funded by them. Diabetes UK is heavily dependent on their largess as is the US equivalent the ADA.

It is not inevitable that Diabetes is progressive and life shortening unless the 'mainstream' treatments are pursued. Many know this and either overtly or covertly follow their own agenda and are considerably healthier as a result. When J' gets a day when her three times a day tests, all come out as normoglycemic purely by gist of diet, a little exercise and a few supplements, it is a cause for celebration. It can be difficult some days, there are pitfalls in many foodstuffs that are not evident at first analysis but by testing rigorously they are soon found. But if you are not taking a hypoglycemic drug they are not funded by the NHS. So you have to buy them yourself. So you save the NHS lots of money by being responsible for your Diabetic destiny and the mealy mouthed idiots then penalise you for so doing. Crock of s**t or what?

I will continue to post the continuing saga as and when it happens. J' is somewhat handicapped as a Diabetic because her piss poor prosthesis is not conducive to vigorous exercise and that is a useful protocol for any diabetic to lower insulin resistance and 'burn off' excess glucose. So she has been doubly damned by the arrogance and stupidity of a system that is incapable of factoring in individual needs in treatment. Thank you NHS for making sure the law of unintended consequences rules!

Hubris, Dominance and Radicalisation.

The Patient Experience.

In my recent relating of the experience of my partner's sojourn at the 'dark fortress' that passes for our local teaching hospital (sic), I spoke of the 'loss of innocence'. It's a concept that is perhaps a little hard to grasp, but is the factor that is the springboard of the radicalisation of many patients and the birth canal of advocacy groups. It is worthwhile then to examine what drives this and why a significant minority of patients find themselves at loggerheads with Medicine.
 
Many of us go through life, with little to no contact with Doctors', or if we do it is for simple and easily remedied needs that are adequately fulfilled by the primary care GP. Some, generally with little in the way of understanding of Healthcare, accept what they are given because of the adherence to a thought process that is still (surprisingly) in vogue, that 'Doctor knows best'. Well that used to work for my mother, and over the years to an extent for me too, but once we have a bad experience, some although not all, begin to question the veracity of that paradigm. My friend, the Registrar once said to me that one Doctor who treats a patient badly and causes harm, shames the whole profession and initiates an alienation of that patient to Doctors' often for the rest of that persons life. That is true, and summarises my feelings about the various shortcomings of the care J' received, but it's more complicated than that. In fact the patient versus doctor warfare that has taken place over the years since the NHS came into being can be characterised by the overt coercion, disempowerment, objectification, and devaluation of the patient as their own moral agent.

These problems arise from a lack of courtesy through to actual harms, and inculcate in many an aversion to the profession as a whole, some of whom do not deserve it, except of course to say that they allow it go on with little demur. Keeping patients waiting, for a pre-arranged appointment is the beginning, characterised by the practise of 'over bookng', common in the NHS.  This sows in the mind an attitude of contempt; a devaluation of the time of a patient as being worthless and that of the Doctor as precious.

Domination.

Then there is then the dominance of the Doctor in the relationship, with very little adequate understanding of the anxiety they inculcate within the patient by the (often) overbearing and overcomplicated language they use to describe both conditions, and the  protocols invoked for treatment. There is often a failure to impart information about the side effects and dangers attached to many of the treatments advocated and indeed an often patronising stance by the Practitioner that the patient does not understand what is being done and this often diffuses and even negates the the concept of 'informed consent'. This is the stance assumed by many Doctors, that they should not tell the patient too much, so as not to frighten or baffle them, especially if they are women (covert misogyny).

Many treatments even tests, carry a burden of danger that is almost always withheld or 'glossed over'. Radiotherapy, Mammography, HRT treatment, many drug therapies and even anaesthesia is often portrayed as benign and patients who complain are often treated with disdain or even hostility.  In truth, most if not all aspects of medicine or surgery carry risks, some serious others less so, and often these are different in some recipients more than others. Many of these protocols are now seen as counter productive, dangerous, and even fatal in some  cases, but the patient has often been coerced, covertly or overtly to accede to them. So then domination takes from the patient their autonomy, that essential sense of  'self' that guides and governs most of our actions. Removing this takes away the option that one should always have; not to follow the path advocated because of prospective harm, whether perceived or real, because not accepting a course of treatment is a patients inalienable right. Withholding information of harm can guide a patient down a road that they would have otherwise have not taken. It also breaches the ethical code of Doctors' and that of their (piss poor) governing body, the General Medical Council (GMC).

Hubris.

Most Doctors' hold the view that they generally act in the best interest of patients' and that they are guided by science. They focus upon the good that they do. In doing so they often neglect the harms implicit in the drugs and protocols they champion as efficacious because they view most of these harms can be balanced against the overall good they achieve. They turn a 'blind eye' to iatrogenic (doctor induced) harm because it does not fit with their ideology of acting in the best interest of their patient. This hubristic attitude extends to many areas of Medicine and is part of the self delusion that comes about from power; power over the patient.

The primary example I would cite is that of the practise within Primary Care of the adherence to the Quality Outcomes Framework (QOF). Doctors get paid for fulfilling protocols that generally are political in origin, rather than being steeped in any sort of evidence based medicine, such as the lowering of cholesterol, reductions in blood pressure, avoidance of saturated fat, five portions of fruit and vegetables a day etc. Few if any, have any real belief that they are doing any particular good, and a significant minority are convinced that they are actually contributing to harm. Yet GP's continue to undertake the various tests to prove adherence to these protocols, that are only 'surrogate' markers of disease. These have largely been proven as worthless  But they garner fee's for the GP's practise. Can this be called indicative of patient care?

Another example, in Orthopaedics, is the use of the now much criticised metal-on-metal hip implant. Now anyone with engineering knowledge would have immediately spotted the fatal flaw in the concept of such materials in an environment where even with lubrication, which is impossible unless you install a grease nipple on the outside of the hip (and even if you could the grease would be toxic) wear of some quite high order would take place. This is called 'tribology' and is the science of wear. Engineering science seeks to limit this wear by the introduction of an interface between the frictional surfaces called a lubricant which overall slows down wear. An engineer who could introduce to the world, a lubricant that eliminates it completely would be able to write their own paycheck, and it would have many zero's at the end. Yet surgeons continue to utilise this and many other implants, that inevitably wear away, some at alarming rates, and consequently put patients at risk and condemn them to further surgery. Surgery of a significant level of risk and often on multiple occasions sometimes resultant in death. 'Do no harm'?

The harms perpetrated on Diabetics is perhaps the most scandalous of all protocols practised in Primary Care. Many Type 11's abandon the advice they are constantly given, either overtly or covertly, because most aspects of their condition continue to worsen if they adhere to the drugs and diets prescribed. They exemplify, perhaps more than any other cohort in the treatment paradigm of the QOF, the poor standard of science and the dangerous and patently stupid protocols advocated. The worst of these is to advise patients to consume carbohydrate, which turns to glucose in the body in very short order after consumption. Reduction of blood glucose is precisely that which Diabetics have to achieve to be normoglycemic. Why in the name of Hippocrates would you instruct a patient to indulge in that which is to them a 'poison? So you can give them some more of those 'nice' drugs that 'Pharma' says is essential to normoglycemic levels? It is 'wibble' and dangerous 'wibble' at that. And it is more likely than anything else to spawn even worse levels of blood glucose, with the consequent elevation of other symptoms and the need to 'crank up' the volume and number of prescribed drugs.

Doctors and others in health care are often blinded to the harms the patient receives and often disbelieve them because it impinges upon their feeling of self worth; their absolute belief that they act in the best interests of patients, even when they are wrong. Their dominance and hubris is bordering on delusional and they often dismiss patients views because they do not talk the same language Fortunately a significant number of Diabetics are taking control of their own destiny and this is on the increase and the subsequent HbA1c results they are achieving is testimony to the elemental stupidity of the advice they are given. More power to them! They have been radicalised.

Radicalisation.

Since the beginning of the NHS patients', tired or traumatised by what they or those they love have suffered, have sought pathways to telling their story, seeking redress, a simple apology, or even, on rare occasions, revenge. They have found it impossible; Doctors viewed them as mad or bad. The NHS and the systems and organisations set up to safeguard them, or to allow them to seek redress have been fatally flawed because they are part of the 'establishment' of the State, and thus have a vested interest in preventing or subverting that end. Set up to fail the patient then, already radicalised, becomes even more bitter, more radical, because there seems to be no outlet, no avenue down which to pursue the perfectly reasonable need of righting wrongs or preventing further episodes of harm. They either give up in in disgust, are buried (literally), as are most Doctors major errors, or they enjoin together with others of their kind to form pressure groups.

Some of these have been successful. But some like The Patients Association or Action Against Medical Accidents, have virtually joined the very establishment they were formed to combat. Others such as Diabetes UK, or Heart UK and many others have simply become mouthpieces for the political goals of the Neo-Liberals or worse, the sales promotion teams for 'Big Pharma'. There is in fact no avenue left for the radical patient who seeks justice, candour or redress, other than their own efforts, the rapacious legal sector, or by joining a pressure group that is not part of the 'establishment'. When there are, at conservative estimates, 34,000 deaths and 40,000 serious injuries per year as a result of medical errors (National Patient Safety Agency figures), it is an appalling indictment of our political system that we have no effective means of obtaining anything more than a few weasel words of sorrow when death or serious harm is perpetrated against us the patient. And at some time in most of our lives we will all be given that title.

In writing the forgoing I wish it to be known that I do not 'hate doctors', in fact I admire quite few, but I do hate the power structure they enjoy and the virtual immunity from any ordure in the event of causing serious harm or death. We need a a 'duty of candour ' in the UK and a system of justice that allows it to flourish.

(For anyone wishing to look at the support and pressure group of which I am a member, click on the scales of justice).

This post is dedicated to Robbie, David, Catherine, Stephanie and a legion of others who lost in the gamble of placing their trust in Medicine and the NHS.

Loss of Innocence (The Complaint).

I left the story last at the juncture where I was trying to fathom what had happened to J' whilst she was in Hospital, and why so many things had gone wrong. I had been trying to convince her, that we needed to both find out exactly what her prosthetic hip, was and to ascertain why she had been so ill postoperatively, at least.

It took some convincing, on my behalf as J' wanted to put it all behind her; to forget all about it completely, whereas I did not. I did quite a lot of soul searching, as I knew that J' continued to display stress when talking about events that had occurred and I did not want to coerce her into anything. It was painful for me too, but I felt it imperative at least to garner some information, so as to guide any action in the future. So the first step was taken; that of requesting all the notes about her Hospital treatment.

What may seem a simple request, turned out to be more difficult than anticipated and I sought the help of the Patient Advocacy Service to assist me in this. I was not confident that they would be of any use but was pleasantly surprised by the case officer appointed, Andrew (not his real name, which I never knew) whose knowledge and understanding was of great help. So we submitted a request for the medical notes and sat back and waited, and waited. Well it took an age, cost some £50 and came in instalments. And of course you have no proof that what you receive is comprehensive, because you do not know what may have been omitted. Some two months later we actually had them all and I commenced the task of review.

Despite my knowledge of Human Biology and Biochemistry, I admit to floundering somewhat; well quite a lot actually. I had not looked into science in this area for more than thirty years (my how time flies) and I found that I not only had to hit the books, but had to buy some more contemporary ones. But of course we now had the Internet, except I had not used it much before, being a bit of a 'luddite' in a way although I had embraced microprocessor logic quite extensively. So now I had to embrace that as well. But after a few hiccups I was soon getting up to speed.

My review of the various tests conducted proved to be the most illuminating element of J' treatment and the memory I had of the Paramedics question, about controlling her Diabetes soon became understood. Her preop' blood glucose was 19.50 mmol/L ! That is severe, uncontrolled hyperglycemia, a situation that could only indicate Type 11 Diabetes. In addition she had been given a 'bolus' of several antibiotics including several penicillin's. She has a well documented adverse reaction to this type of antibiotic, which was advised to the Hospital on admission and it was clearly stated on the notes. There was also strangely, a copy of an ECG trace together with a chest X-ray copy (on disc). These were 'ghosts', because no such procedures were undertaken, and let's face it it would be extremely difficult to 'sneak' an ECG onto a patient, with ten electrodes having to be placed onto various parts of the body and the machine, being wheeled into the cubicle, especially as I was there too. Bizarre is the only word I can use for this.

So the first thing I had to do was to address the distinct possibility of Diabetes. I knew that high blood sugar is symptomatic in trauma patients, it's part of the human stress reaction, but not anything like the levels reported (and ignored!). So I purchased a blood glucose monitor and some test strips and tested J' for both fasting and post prandial (after a meal) levels. I did this on three days to be absolutely certain and the figures were indeed well above normoglycemic levels, in the region of 10mmol/L (fasting). So whilst I was by then sure she was a Type 11 Diabetic, it has to verified by a Doctor for this to be 'official' so we had to make an appointment to see the GP which we did. When we talked to her (the GP) she was also convinced of the same and immediately wrote out a 'scrip' for Metformin. And she gave us a blood test instruction to be fulfilled at either of the two local Hospitals. I viewed this as somewhat premature, but she dismissed totally the concept of diet and exercise as a protocol for containment of the Diabetes. A rush to judgement? Well pretty much I felt, so we did not fill the prescription and never did.

I had already completed some research into Diabetes prior to the GP visit as the only thing that I could recall from College was that the 'Islets of Langerhans' become non-functional and thus produce little to no insulin. J' also had more practical experience than I, as her father had Non Insulin Dependent Diabetes Mellitus (NIDDM) for a large part of his life. But his condition was treated with diet and exercise. That frankly was my take as well because that had been the protocol for most, thirty or more years ago. What had changed it seemed, was the fear of fat and meats, as the diet route dictated that little to no carbohydrate be consumed. As all carbohydrates convert to glucose in the digestive system somewhat rapidly, it also made biological sense to shun them. What had changed then since my studies in the 1960's? Well quite a lot it seemed.

'Big Pharma' in it's ceaseless pursuit of money had become all powerful along with Diabetes UK, an alleged patient advocacy organisation, and their dominance of  the treatment paradigm now in place dictated that Diabetics take a cocktail of drugs including it seems Insulin. Insulin Dependent, Non Insulin Dependent Diabetics? Well that seemed somewhat nonsensical. More research was obviously needed and urgently, but we did concentrate our efforts, (for by this time J' was 'onside' about this, if little else), on reducing carbohydrates with a view to elimination.

After more heart searching J' finally agreed that we should also register a formal complaint with the Trust about her treatment and now, because of the notes, we also had (at last) found out what 'they' had put inside her (hip). It was a bi-polar hemiarthroplasty, which is a 'hemi' with a plastic cup added to the top of the head (ball), that was 'stuffed' (no other word describes it better) into her acetabulum. Research sadly does not attribute this with any better outcomes than a simple 'hemi' and the recipient also has more plastic debris to cope with together with little in the way of less acetabular erosion or protrusion. So it is little better than a simple 'hemi', just a bit more expensive. It had taken more than four months to determine the presence of this prosthesis, which somewhat flies in the face of so-called 'informed consent' we were alleged to have given.

And so the Complaint System rumbled forward, until we at last had a meeting. I have written about this in detail a while ago and do not propose to go over it again. Suffice to say we were both devastated by the outcome and resolved to pursue things further, but frankly the ground rules kept moving throughout the procedure making it difficult to find our way. The Brown Government, overseen by that most useless of all Health Secretaries, Andy Burnham decided that a change was needed halfway through our complaint, and we were now left with no choice than to complain that we thought we had been dealt with unfairly, and that the 'Local Resolution' system should review the case once more. The response to this was a refusal, leaving the 'last hope', a referral to Parliamentary and Health Service Ombudsman as our final port of call. But at this stage we decided to concentrate on J's various problems and look for as many solutions as we could.

These were; the need to restore her mobility as much as reasonably practicable with the poor prosthesis she had been given.
To control her Diabetes and achieve normoglycemia as much as possible with the minimum of side effects.
And to investigate the pronouncement about her having osteoporosis we found in the notes.

She had a pronounced limp, termed Trendelenburg's Sign, which was placing some strain on her left leg. We needed some physiotherapy intervention for this and, luckily the PCT in the area had a a policy of self-referral, so we did not have to see the GP for this. Using a bit of 'leverage' in my circle of  friends, I was able to get her an appointment quickly and we got one of the best in the area. He agreed that J' needed help and devised a work plan that involved resistance exercises that I had to help with, that rebuilt the muscles damaged by the operation. It was hard for her and sometimes painful to see, and often I felt terrible for driving her efforts. But after three long months, it bore fruit and the limp was gone. It also helped with her Diabetes by gist of the exercise needed which reduces insulin resistance in the muscles that helps to lower blood glucose.

Her Diabetes gradually came under control with a low carbohydrate diet, regular exercise with walking and an exercise bicycle, together with a few carefully targeted supplements. Her Hba1c reduced from 8.5 to 6.5 in three months, she lost some weight and the youthfulness she formerly displayed, gradually returned. There was a lot more to achieve as yet, but the walks along the canals helped to keep us both reasonably fit and sane. J' had gone from a vibrant, youthful woman, holding down a well paid job to a partially disabled Diabetic with alleged 'brittle' bones, needing help with at least some aspects of life. She had to have an automatic car, help with getting in and out of bath and could only work part-time.

No one person or organisation was responsible for the accident or the Diabetes, but what the Trust did was to ignore many obvious and relatively simple measures that prejudiced her recovery, her future, her very life even at one point, without any sense of responsibility for their actions and lack of them. No sense of danger in their lax and supine protocols; no remorse, no empathy, but above all no candour and no justice.  I had lost my innocence about 'our' NHS, an organisation I had championed in the past, even been grateful to for saving the lives of two of my children. Yet now, after the injection of extra billions in funding, it was actually worse than when it was a service for the poor 'proles' back in 1948. It was devoid of humanity, and the primary tenet governing all that medicine stands for, 'do no harm', because it was doing great harm and 'selling' it as care. It had made an enemy of me and I was to learn in the coming months, many others too. I was no longer 'Winston Smith' and I no longer loved Big Brother.

This saga continues shortly, after I catch my literary breath.

Slicing The Salami (and calling it steak).

I am taking a brief respite from the 'Loss of Innocence' saga, to excoriate about the publicity for the study about the intake of meats causing Cancer. Much was made of this in the print and broadcast media with precious little criticism or adverse comment from, well anyone. But in truth it was like most of these proselytising studies, that attempt to steer us from the path of our demise by feeding us the results from 'scientific' research that is not really scientific at all.

The study, published in the Archives of Internal Medicine is an observational study, which means it is not presenting any evidence, merely drawing conclusions from data provided by food frequency questionnaire's filled in by the cohort every four years! I can't even remember what I had for dinner last Tuesday, except to know it would have had meat in it; probably lots of it. These epidemiological type studies are really the starting point of a hypothesis to test it's credibility. They are not the end point, merely the beginning of a journey that should encompass all of the checks and balances that science should pursue to ensure that any statement made about anything should at least be founded in proven fact. So, is it likely that the cohort from whom the data was drawn, reported the facts of their diet without telling a few little lies? I really think not, but that's a side issue really.

Let us then look a little deeper. Firstly we see that all meat, processed or otherwise so long as it's red, is alarmingly 'lumped' together, although they do within the study provide some separation of the two and indeed indicate that 'processed' meats are more harmful than other types. But looking further we find that the actual questionnaire lists hamburger meat as 'unprocessed'. You can read about the reliability of Food Frequency Questionnaires here. This highlights the tendency for the cohort to over report socially acceptable foods rather than those they have been 'brainwashed' to reject, but nonetheless still consume. It may also not escaped your attention, that it is the same Institution that also produced this study. Ironic? I could not comment.

So 'hamburger' meat passes for red meat in the US. And to some extent, if you want to give credence to any of this rubbish then remember that the cohort is entirely comprised of US citizens. There is meat, and then there is American meat most of which is 'lot fed' in corrals most of it's life and fed on concentrates of soy protein, cattle corn and antibiotics. It's no longer meat as we know it! Europeans although consuming meat of this type in small amounts, generally eat grass fed beef and lamb, the latter of which is a large part of their 'red meat' diet.  So if this study proves anything (and I don't think it does) it proves that eating US meat and all the other elements of the diet, of those who filled in the Questionnaire, could possibly, maybe, cause Cancer. Of course there are numerous confounding factors that go unreported such as, what other elements of the diet examined might be contributory to the conclusions about Cancer? All of the cohort may have also drunk vast amounts of alcohol or worse, coke! They may have all been drug addicts for all we know, because it is unreported.

Looking then at the science, about the higher reported incidence of Cancer in those who ate lots of processed meats. There is a mechanism that could be responsible, and again it's something that predominates more in the US than Europe or the UK, and that's nitrites. They are an additive used in the preservation of hams, sausages, bacon and continental sausage. Sodium Nitrite (E250) is used to add colour but more to prevent the growth of the bacteria Clostridium Botulinum, the cause of botulism.

When man started to preserve meat, natural sea or rock salt and air drying were the main agents, but as we became frightened of salt and to speed up processing we began using chemicals. Preserving salts today have the addition of 0.6% sodium nitrite or the potassium version to guard against botulism because we now turn around the processing of meats so quickly that it is much more probable, well not really (anymore) but it does make the product nice and pink. Many long matured air dried 'artisan' sausages do not need it and it's a good idea to avoid it if possible. It is not much of a poison the Lethal Dose 50% (LD50) is 71mg per kilo for humans but nitrites form nitrosamines, which are carcinogens, if they are heated in cooking at high temperature. The highly acidic environment of the human stomach can also bring about the same condition. So it is usual, and a legal requirement in the US, to add ascorbic acid (Vitamin C) at 550 ppm to preserved meat or any meat treated with nitrites. The acid inhibits the formation of nitrosamines and in fact the incidence of stomach cancer fell significantly in the US after its addition to preservation methods.

It is a good idea not to roast ham or fry bacon so that it is charred or too crisp, or to limit intake. If one does eat bacon crisp, which is the way most like it, then take a Vitamin C supplement, it helps to prevent Cancer anyway and is rarely harmful. Alternatively eat high quality processed meats that do not have nitrites, although you may have to go to some lengths to find them. Nitrites can also be found in many green vegetables and root vegetables especially, so you do not want to overload on these either. Lettuce, Spinach and Radishes contain the most and a significant proportion of this can be attributed to the use of nitrate fertilisers. The more mature the plant the lower the level of nitrite. Organic vegetables are usually lower in nitrites than those grown by the multinational growing cartels.

A rare result of over consumption can bring about methaemoglobinaemia, which robs the haemoglobin of its oxygen absorption capabilities and causes hypoxia (oxygen starvation). But one would have to consume vast amounts of nitrites for this to come about and most cases are due to other causes. Again an intake of Vitamin C is both the treatment for this rare disorder and is protective against nitrosamine being formed from nitrite ingestion. Most animals produce their own Vitamin C to combat this but a few, including man lost this ability at some time in the evolutionary chain. And to get enough of this vitamin, drinking orange juice will not cut it I'm afraid. Orange juice is flavoured with err... orange flavouring, because natural orange flavour only lasts hours. So, the processors have to add it back to the packs and bottles it comes in, otherwise it's orange water. Man cannot get enough from diet of this vitamin in today's nutritional environment unless we supplement or eat targeted foods high in its content with watercress being one of the best. However, most green leafy vegetables including cauliflower provide substantial amounts, but yes are also high in.....nitrites! Oh, just take a pill!

 So eating preserved meats does have a mechanism that could be causative of some cancers, because it does actually exist, but frankly you would have to eat really large amounts, on a regular basis. And, the bun surrounding the 'unprocessed' burger meat (sic) is likely to be more harmful. And what country is renowned for it's consumption of burgers and barbecued meats? Might that be the country of origin of the cohort of this study, the USA? Always remember, long suffering reader, that observation (and correlation) does not prove causation.

Loss of innocence (part four) continues shortly.