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.

Drugs Nemesis?

And so, we say farewell to many of the most profitable drugs of 'Big Pharma' this year, with big names consigned to the bin and the 'generic' versions now being born to treat symptoms or more realistically, the surrogate marker of those. I say 'treat your symptoms' because Pharma rarely invents anything to actually make you well, or even better than you were, except perhaps for Antibiotics. However, that strand of drugs design is getting ever more difficult, ever more unprofitable, because the life span of such drugs is getting ever shorter and drug cartels are becoming ever more reluctant to pursue the goal of a new and better antibiotic because the returns are diminishing with each year.

Here is list of the more important items coming off patent during the coming year. Clicking on the name will take you to an explanation of it's use, but many of you will know them already. They are;-
1. Cozaar/Hyzaar - Merck
2. Lipitor - Pfizer
3. Flomax - Boehringer Ingelheim
4. Arimidex - AstraZeneca
5. Climara - Bayer HealthCare
6. Aricept - Aricept
7. Invirase - Roche
8. Hycamtin - GlaxoSmithKline
9. Protonix - Pfizer
10. Levaquin - Levaquin

Things are in fact getting so bad that the Investors are fleeing the market.  $50 billion is the estimate of lost sales that will occur accumulating to $250 billion by 2015. And money is leaking from the coffers to settle bribery cases that have been brought to light in many areas of operation.

Pharma also faces the loss of income from the harder line now being taken by the FDA about approvals of both new and existing drugs for use outside original approvals. There is in fact a new era of stricter regulation that seems to be dawning in the USA, with bribery scandals abounding at the same time as many drugs are being 'canned' due to failure in trials.

It may mean that NICE may actually look at some of the drugs it has approved on the back of FDA approval (that's the way it works, or maybe doesn't) and review it's strategy because huge amounts of our taxes are being wasted prescribing drugs that do little or nothing to improve the patients lot and in many cases are proven to be dangerous or even life threatening, such as Avandia or Risperdal. Often newer drugs are brought to market because the old one's are running out of patent, not because the newer one's are any better and Pharma goes to tremendous lengths to 'sell' the new one which includes bribery, false reporting and trials that are 'fudged' in an attempt to reap more profit.

They undertake this in many and disparate ways, but one of the most common is to 'fund' trials. Now those who undertake these are often viewed as 'indepenent' but considerable evidence has now accrued that often these researchers are far from such. And reporting is always subject editing by the sponsor with some extremely onerous conditions applied that then prevent the academics involved from having access to the full data.

Failures are not only confined to drugs, because Pharma also does a nice line in joints and prosthetics, quite a lot of which are used by our NHS and they fail. Fail quite badly, causing the recipient much pain and distress and the horror of undergoing re-operation, often when their overall health means that such procedures can be life threatening.

I could go on almost ad infinitum, about the drugs and medical devices and I must acknowledge that modern medicine does need drugs. From time to time most of us will require some intervention that a drug can provide. My feeling  about this is  the same as that for penetrating radiation, 'as little as reasonably practicable' or ALARP. I do not feel that any person should be on a drug protocol, simply to fulfill some 'surrogate marker or end point' such as statin therapy, except in rare cases, because we do not need to medicate 'well' people. We also do not need to over prescribe antibiotics because by doing so we will reap a harvest of problems in the future, which is already manifesting itself in the spread of MSRA and other 'hospital born' infections. There are plenty of treatments for minor ailments that do not warrant their use and we certainly should ban the use of them in animal feeds, because by doing so we are less exposed. We should also review their use in routine surgery; are our Hospitals so filthy that we need to dose people with them on a 'just in case' basis?

Preservation of life is the most important goal of Medicine, but this is not the goal of the Drugs Industry, it's primary aim is to make money for shareholders, that is enshrined in company law. All too frequently this has overridden patient safety and the QOF protocols of 'payment by results' has seen a huge rise in the drugs bill for the NHS; see;-You Spent How Much! So far as most of the outcomes are concerned, certainly for many of these drugs, little has been achieved. Is it not time to refrain from gifting 'Big Pharma' with undeserved benevolence, when it is really little more than a corrupt pariah, that occasionally comes up with something worthwhile, but most of the time contributes little to the nation's health and often endangers it?