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'.

First They Came For Your Daughters.........

And now for your son's.

A recent headline story in the Independent caught my eye as an example of 'disease mongering'. My dislike of HPV vaccination will have been made clear from my last post, as I feel it is a somewhat large hammer for a very small nut. The vaccine Gardasil, from Merck is seen in this light by myself and and many others. Age standardised mortality rates of Cervical Cancer in the UK stood at 2.4 per 100,000 in 2008 and falling which is a risk of .0024% if my calculation is correct. Down it seems from 1971 of 7.1 per 100,000 and in most of those years the vaccine did not exist. It is also somewhat easy to cure and in many cases no harm results from infection with even the low percentage of CIN 3 lesions detected only progressing to actual cancer 1% of the time. So why we should vaccinate against such a problem bemuses me, when we ignore many other cancers of much higher rates of incidence.

Michael Douglas, a throat cancer sufferer.

A new 'epidemic' it seems, is now being sold as a reason to vaccinate young boys as well as girls. We are told, that Oropharyngeal Cancer (throat cancer) has increased alarmingly, by some 73%! And that HPV vaccines will guard against it's further spread. It is only when you read the actual figures that the figure is put into context. A rise from 1 per 100,000 to 2.3 per 100,000. So yes, it is a rise but that's the 'actual' (rather than relative) risk which remains almost too small to measure, in scientific terms. And one must remember that the 'actual risk' of harm from the vaccine itself. exceeds that figure by some 50% (playing them at their own game), it's about 3.5 per 100,000.

The increase is laid at the door of 'yoofs' predilection for oral sex as opposed to the 'missionary position' one assumes, which does lend to them, some inclination against unwanted pregnancies. It's a pity that such a risque form of sex should be viewed as 'risky' by the Professor (honourary) who broke the story; Hisham Mehanna. This practise increases the risk of HPV infection of the throat by this 'staggering amount' (sic), sufficient for him to advocate HPV vaccination. Yet quite a number of Scientists find themselves at odds with this because the protocol remains largely unproven and in most cases the recipients would have to wait some twenty to thirty years for any evidence that it was, to come to light. And of course, the vaccines do not protect from all HPV strains so their effect is at best 70% for 4 to 10 years.

At the moment the NHS continues to roll out the HPV vaccination of young girls but not boys. This story is a 'move' by someone who combines both Private and NHS careers to frighten young women, girls and now anxious parents, to press for this vaccine to be available for all. It seems a cynical ploy to me to once more 'generate' more things to do for an already declining resource fund; the NHS. I could point out that Mehanna receives funding for some of his studies from GlaxoSmithKline, the maker of one of the two major vaccines; Cervarix. But of course I wouldn't do that, would I?