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'.

2011; End of Term Report.

2011 seemed a little like living in some sort of  'time warp'. Paranoia reigned, mainly about 'benefit scroungers' and immigrants and the need to ensure those that are financially supported by the state 'get a job'. A bit bloody difficult that if there aren't any! But of course such policies appeal to the baser instincts of the people who are (generally) misled into the view that all on the 'dole are shiftless, workshy leeches. They may of course change their mind about that, when the redundancy notice drops on the mat.  And of course we had that elaborate fireworks 'jamboree' at the Thames Embankment, at the turn of the year. 'Circus' (without the bread)  would be my summation of that. They'll be plenty of the circus element to take out our minds off the the 'crisis' in 2012 with the Olympics (which has just had an extra £270m added to the bill for security to pay for an additional 13,700 personnel from G4S. That works out at £20,000 for six weeks work yet the 'going rate' is about £10 an hour. Could it be that we are being 'screwed', by the Governments favourite 'Security' Co? ) and the Jubilee celebrations being the most prominent, but still, we get a day off work to pay homage to the Royals, so that's alright then!

Delving into the 'nitty gritty', this was the first full year of the Toffs Academy's rule and Edd and, err Edd's reign on the opposition benches. What a triumph it all was, with the competition for the middle ground of mediocrity almost reaching fever pitch. The cut and thrust was painful to watch, with minutiae of each of the party's doctrine being dissected and found to be - the same! The Headmaster shone through it all with aplomb, and that was just his face. But seriously, where is the difference, the defining policy, the moment of inertia that could lift us from this politically imposed state of misery in which we are living; I'm still waiting.

'Hacking' came to prominence, with News International holding up it's hands to the offence of listening to peoples voice mail messages. Well sorry, I simply cannot get worked up about a a bunch of idiots who are so stupid as to actually leave any significant personal information on a mobile phone voice mail system, which is designed to ensure that you know someone called when you were on the 'phone or off the air! Nor am I impressed by the state expending my money on an enquiry that is designed to 'up the ante' on the damages that will be paid to a bunch of self serving, publicity seeking third rate celebrities like Prezzer and 'Huge' Grant. If NI had actually listened in, to a 'phone conversation, that would be different, but they didn't. That privilege is reserved for the security services and the US Government. So get over it, go home and stop filling the media with your contrived and silly outrage; it's your own fault!

Meanwhile, back on Earth or the planet Zog, as it seems to me (or maybe 'Life on Mars' as Francis Wheen says) much more important things were happening.

The NHS was transformed from being a dangerous organisation, entrenched in mediocrity, mendacity and self interest, to a 'shining light' of health care for the people. Privatisation and Marketisation was the route being taken by the Government, but that was a step too far for the pressure groups that sprang from the woodwork. Many of these comprised of Doctors and other Health care providers complicit, even actively involved in the reforms of  Tony Blair. Well wake up and smell the coffee, it's already happened! What do you think ISTC's, Foundation Trust's and Primary Care by GP's is! The last 'lot' (Labour) were already well on the way to that goal before Cameron et al came on the scene. GP's have always been private contractors to the NHS, either as partnerships, individuals or limited companies. If you want to criticise a system that allows this, then start with them. They've always stood on the outside, looking in, and however you want to cut it, GP's are not state employee's, which only makes me wonder why we are contributing to their pension's, but that's another story. And, all of the hand wringing of the 'Guardian' readers seemed to be out of step with the fact the Nu Labour had been the architects of most of the changes in the NHS, and Lansley is only continuing a process commenced by Tony Blair and Gordon Brown. So everything is different, but stays the same.

The 'bandwagon' of Pharma continued, although in somewhat abated form now that the so called 'blockbuster' drugs have gone off patent, and some of the seedier advances elicited huge payouts for the harms they had caused ($3 billion from GSK for fraud and mis-selling), but that didn't stop Andrew Witty getting a knighthood. Who says crime doesn't pay! Cameron decided that they (Pharma) were so poverty stricken that we needed to give them some of our money and a lot of our patient information, to get them to cause some more carnage by helping them develop some new drugs. We need some more 'lifestyle' drugs like a hole in the head, and the hand full of very expensive drugs thus far developed to treat relatively rare conditions have only had modest or even no benefit to society, except of course to Pharma's coffers.

The NHS remains 'broken' and all the rhetoric about 'saving it' is counterproductive. More 'marketisation' will not make one iota of difference to current appalling status of the patient in all of this. 2011 saw the exposure of terrible standards of care that have prevailed, and been tolerated for years. Winterbourne View, failure to provide adequate nursing, dignity and nutrition to the elderly and those with mental health issues and learning problems. The 'Stafford Hospital' enquiry, the appalling problems in A&E at weekends and nights, and substandard care in Trauma and Surgery; the list is almost endless. A new paradigm needs forging to bring the NHS up to a standard that is in accord with the vast sums expended, most of which has been allocated to the payment of the management, consultants and temporary staff at exorbitant rates. And of course PFI, PPP and ISTC's. Despite the fact that the ConDems criticised the finance model, they have still seen fit to go ahead with the £450m Liverpool Hospital PFI contract with a consortia of Laing, Interserve and FCC. There is also some evidence that Trusts are retaining patients on wards, to enable payment of treatment tariffs simply to 'grab the cash', when many could be discharged to home (much safer than hospital) and treated by their GP's.

All of the privatisation and commercialisation models will do nothing to advance patient care. To proffer the view that excellence will be intrinsic to allowing further private companys' to undertake treatment at Primary or Secondary level is littered with pitfalls. Thus far it certainly has not been proven, in fact costs have escalated out of proportion to the outcome. Time and time again it has been demonstrated that the private sector is only interested in 'cherry picking' those areas of treatment that are simple and straightforward and with little to no need for the 'back up' of an emergency department, and when things have 'gone wrong', which they have, patients have been rapidly handed over to NHS Hospitals to try and salvage something from the situation. 

Competition has long been viewed as being the spur to excellence within capitalism by successive governments since the Thatcher days, but the proof has been sadly lacking, with greed and mendacity demonstrated just as readily as in the public sector, in fact the paradigm has been so corrosive as to be valueless. Numerous companies have been earmarked by Government as 'preffered providers' in many sectors and proven to be incompetent, target driven, purveyors of substandard products and services. The simple model of capitalism is 'buy cheap and sell dear'. There are better ways of producing a better outcome for patients than that. We only have look to Winterbourne View and to the NHS IT programme to see the failings of the unbridled pursuit of money.

The organisations too, that oversee the NHS and Social Care also continue to give concern, with the CQC failing miserably in its raison detre to protect the vulnerable and curb dangerous practise because it spent too much time on the registration of the myriad components of Health care (which yields its funding) than on the protection of patients from harm. It does seem to have raised it's game a little now but like most things in Health care it's too little and too late.

And what of the Medicines and Health care products Regulatory Agency (MHRA)? Well, they seem to have gone to sleep on job, because they were warned back in 2006 about PIP's toxic breast implants after approving them without demur years previously. Could it be anything to do with alleged opinion of many that they are a bit 'cosy' with 'Pharma'. As is usual, I could not possibly comment on such a salacious view! Perhaps if anyone had checked the content the penny might have dropped because most comprised the sort of silicone used for sealing around baths and showers (Rhodorsil) or for oils seals and 'O' rings in automotive products (Silopren). As even the (fairly lax) FDA in the US banned this device in 2000,  what happened to the continuous assessment process that should have been in place?

Too often the bodies we pay with our hard earned taxes to safeguard us from harm are found wanting. and the NHS which is now consuming approaching 10% of GDP is found to be toxic for patients. When will lessons be learned?  Approximately when Doctors accept a 'duty of candour', or hell freezes over (not necessarily in that order).