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Tuesday 12 April 2011

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?

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