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'.