Friday, February 15, 2013

With a pill for every possible situation, pharmaceutical companies see patients as no more than pound-signs - - The Independent

As if our suffering patients didn’t have it bad enough, now the pharmaceuticals go and announce the failure of yet more drug trials dashing hopes for the million UK sufferers of Alzheimer’s.

“Your health is our top concern,” trumpets one pharmaceutical company. Yet if these latest drug failures coupled with the outbreak of scandals surrounding the pharmaceutical industry are anything to go by it makes clear that big pharma’s main concern is anything but our health.

So what is it that drives the industry?

Profit. Obscene profit. To be more precise, profits that rank the almighty pharmas as one of the world’s wealthiest industries along with oil and gas production.

The pharmas devotion to profit is overriding the invention of new treatments for the benefit of our health. According to a paper for the British Medical Journal by Professors Donald Light and Joel, their persistently low rate of marketable novel drugs can be blamed on the measly 1.3% of their billions invested into discovering new chemical entities. Compare this to the whopping 25% they spend on marketing. This means their drugs get more marketing than Nike ploughs into its trainers.

And the majority of these entrants are not even new drugs at all, but so called ‘me too’ products, mere tweaks of existing drugs marketed to boost profits.

That’s not all. The pharmas rely upon a drug development process that sees a 92% failure of all drugs entering clinical trials, as reported by the Food and Drug Administration’s Commissioner in The Scientist in 2004. And this is even after the pharmas have fiddled with the trail designs and manipulated the results to produce favourable data, as Ben Goldacre reports in his book “Bad Pharma”.

All this wily trickery just to get a drug licensed and still the best they are able to achieve is a success of less than one in 10. You would think such an abysmal success rate would flag an inherent flaw crying out for urgent attention wouldn’t you?

Instead, the patent flaw goes overlooked, the quirks in the licensing system persist and reliance upon animal models which fail as a safety screening test for new drugs for humans continues.

What all this means is that licensed drugs present an unknown toxic risk to humans. For as long as we continue to test new drugs on animals, it is we humans who will always be the true guinea pigs – as evidenced by the high withdrawal rate of those drugs that are granted a licence but go on to cause severe side effects. Another paper in the British Medical Journal quantifies the cost of adverse drug reactions at 6.5% (over a million) of hospital admissions and two billion pounds to our cash stricken NHS two billion pounds every year.

To add to this terrifying picture –once the drugs have been approved- pharmas cannot be relied upon to fulfill their monitoring obligations and report these adverse reactions. An investigation is underway into pharmaceutical giant Roche for its failure to disclose reports of 15,000 deaths and 65,000 suspected side effects reported by people taking its medicines over a 15 year period in the USA. Roche has stated that the failure to report was not intentional.

Here in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the government drug regulator responsible for post-marketing drug surveillance. Yet according to a 2005 report by the House of Commons Health Committee the MHRA has fallen into bed with the industry it is supposed to be monitoring. It is entirely funded by fees from those it regulates and, unlike most regulators, it competes with other European agencies for fee income. This has resulted in the MHRA losing sight of the need to protect and promote public health above all else as it seeks to win fee income from the pharmas. But despite these concerns, the government has yet to pass responsibility for the pharmaceutical industry from the Department of Health into the remit of the Department of Trade and Industry, as was recommended in the report.

In today’s era of poly-pharmacy, we are prescribed drugs not only to control a condition, relieve symptoms or cure a disease but also to treat the fit and healthy and keep them just that - fit and healthy, as nature is already doing so well. The Health Committee’s report refers to the “Medicalisation of our society – a pill for every ill” they should add – “and for every person”. The pharmas would have us all medicated, one way or another.

This system is totally unjustifiable. This violation of our health market cannot continue. We cannot allow the commercial interests of the pharmaceutical industry to be prioritised over the interests of patients. The time for a scientific overhaul of the drug development process and tighter regulations over the pharmaceutical industry is long overdue. The pharmaceuticals must swallow the bitter pill; our health should be their top concern.

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