The Journal of History     Summer 2006    TABLE OF CONTENTS

With Friends Like these, who needs Enemies - The Vioxx Scandal Exposed!

It would seem reasonable to assume that the main role of any democratically elected Government is to protect their electorate. This idea seems to have been largely rejected by the present Labour Government in favour of protecting their self-interests and their friends in big business.

Margaret Thatcher is often attributed with having created the "me" society. Where it could be argued that this disposed the party to look after the wealthy elite, New Labour's slant on this philosophy of the 'Self', which they have vigorously embraced, has dictated objectives that seem to look after them first, followed by the wealthy elite in second place. Where the rest of us fit in, is anyone's guess.

This particular form of self-serving Government has paved an easier way for profiteering for the Pharmaceutical industry at the expense of public health. The Pharmaceutical industry's primary role - contrary to popular media and Government-fuelled belief - is to make maximum profits for its shareholders; finding cures for human disease receives far from level ranking.

SPEAK have repeatedly referred to the incestuous nature of the relationship between the top people in the Labour Government and the pharmaceutical industry. It is a flagrant misuse of power and position to achieve own ends. If the presence of the Science Minister, Lord Sainsbury, with his massive stakes in the biotechnology industry weren't enough evidence of a conflict of interest, then his donation of millions to the Labour party, which effectively secured his ministerial position, should have at least caused some scepticism. Better still, Sainsbury was also the prime mover behind the attempt to circumvent the local democratic process and press ahead with what would have been Europe's largest Primate Research Centre on the outskirts of Cambridge. (Until the SPEAC campaign helped put a stop to it, that is).

Oxford University's new animal research facility scheme is yet another project close to Sainsbury's heart - a project, which also received Tony Blair's personal backing. The latest Government pronouncement stipulated that a "Line in the Sand" had been drawn at Oxford. Hardly original, given that SPEAK represenatives have been saying that for the past year. But then a Government that has copied Margaret Thatcher in so many things, can hardly be expected to have an original thought of their own!

But this close relationship of the Government with the Pharmaceutical industry is best illustrated by Sainsbury's baby - the Pharmaceutical Industry Competitiveness Task Force (PICTF), which was set up after a meeting in November 1999 between Mr Blair and the big pharmaceutical companies. The role of the PICTF was to identify areas where the industry's effectiveness could be streamlined within the UK business environment to maximise their power. One of the main aims of the task force was to weaken the vivisection regulations. Interestingly, animal protection groups were excluded from these discussions.

So the very forces that are supposed to be at the helm protecting the people are the forces whose representatives are elbow-deep in double-dealing. "Of course," some might say that SPEAK would try and level accusations of corruption at the opposition as it suits our campaigning strategy and of course that is something that we have to contend with. Yet the truth is that rules and regulations are circumvented far too often where drug testing, manufacture and distribution are concerned, and that there is strong evidence of corruption on many levels.

Where the drugs industry is concerned, market forces act in a very different way to those related to other industries. Adverse reactions to drugs are the fourth biggest killer in the western world, yet despite frequent scandals and poor returns, billions are poured into research, and thus into the coffers of the pharmaceuticals and vivisection industry. This country is no exception, where the latter are upheld by a Labour Government that portrays them as saviours of humankind!

However, if one looks at the statistics and the examples of malpractice in the distribution and safety of drugs, the evidence is, we would suggest, irrefutable. Take for example the most recent drug scandal surrounding the painkilling drug Vioxx, which - according to many experts - caused 60,000 deaths worldwide. Dr David Graham, a senior US Food and Drug Administration (FDA) official, told a Senate committee last November: "This would be the rough equivalent of 500 to 900 aircraft dropping from the sky."

The death of just one plane-load of passengers seems pretty monumental; imagine a scenario in which one airline is found to be responsible for the death of 60,000 people (that is, between 500 and 900 of its planes crash over a period of about 5 years) - how long would it take before that airline went into liquidation?

But the scandal doesn't end there. The deeper one looks, the more people seem to have been involved in conspiring to promote and distributing an unsafe drug - even our very own Oxford University does not escape scrutiny. Vioxx was unleashed onto the market by Merck in 1999. Many painkillers such as naproxen and ibuprofen, known collectively as "non-steroidal anti-inflammatories" or NSAIDs, can also cause fatal stomach ulcers and perforations. In 1999, Merck announced to the world that it had developed a similar drug, known today as Vioxx, which - it was claimed - didn't have these side effects. However, Merck weren't content to market the drug just as a painkiller. They touted it as a wonder drug that could relieve arthritis and cure colon cancer. Hyping up its benefits obviously meant more money, bigger profits.

Even during Vioxx's early days on the market, there was concern about its possible link to heart attacks in patients using it. One of the main exponents of the drug in the UK was Dr Michael Langman, a former dean of Birmingham University's medical school, and a painkiller expert who became a consultant for Merck. Langman refuted such allegations saying it was "a flurry of unjustifiable speculation and controversy".

In 2001, at the peak of the Vioxx hype, Merck reportedly spent $160m advertising the drug. In Britain, where direct advertising is banned, the drug was promoted through doctors, who were offered a free clock as a pay-off for their time and trouble!

A trial of the drug called "Vigor" was set up in the US in order to test whether it could be used to treat rheumatoid arthritis; another trial - "Approve" - tested whether the drug could cure colon cancer. In November 1999, the safety committee monitoring Vigor met to discuss increased blood pressure, "excess deaths and cardiovascular experiences". In October 2000, Merck supplied the FDA with a string of death reports involving heart attacks and strokes. Dr Shari Targum, the FDA analyst, wrote in a report dated January 2001: "It would be difficult to imagine inclusion of Vigor results in the rofecoxib labelling without mentioning cardiovascular safety results in the study description, as well as the Warnings section."

This advice was made known to other regulators around the world. Yet patients in Britain were not made privy to this information, and it is estimated that the drug could have killed in the region of 2000 people in the UK. The plot continued to thicken. A colon cancer trial called "Victor" was set up in Britain by Langman and Professor ----, the erstwhile head of the Cancer Research Campaign Institute, and now a leading Professor at Oxford University, whom we are thus unable to name due to the restrictions of the Injunction. (The Professor, often cited by Tony Blair as an expert in his field (though evidently not expert enough, given the Vioxx fatality numbers!), was a rising star in the new Labour medical elite and a close friend of Alan Milburn, who was health secretary at the time).

Patients in this country involved in the "Victor" trial were notified that the only side effects to the drug were: "tummy pain, dizziness, fluid retention leading to ankle swelling, increase in blood pressure, indigestion and heartburn, mild headache, itching". Despite the assessments of the safety committee monitoring the US trial of the drug being known, neither heart attacks nor any other serious drug-induced symptoms were mentioned. The first heart attack deaths in Britain were flagged up at the Medicines and Healthcare products Regulatory Agency (MHRA) within nine months of the product's launch, so one has to ask the question, why were patients with Colon Cancer being given the drug a few years later and more importantly, why weren't they informed of the possible lethal consequences of taking the drug?

On the 19th August a court in Texas, ordered Merck Inc of New Jersey - the manufacturer of Vioxx - to pay £141.1m in damages to the widow of a Vioxx patient. It is expected that hundreds, possibly thousands of other victims' families of the drug will be filing similar lawsuits. It's very convenient to blame Merck alone for this tragedy and to brush under the carpet the culpability of others. Merck produced the lethal drug in the first place - a drug one might add, which would have been extensively tested on animals (so much for animal testing) but others must also face up to the responsibility for the thousands of deaths in this country and indeed worldwide.

One cannot escape the fact that there was collusion by eminent professors in the UK to conceal the facts about the drug. Nor can one escape the fact that one of those responsible for the continued use of the drug in patient 'care' now holds a key position at Oxford University. It is an indisputable fact that these individuals were privy to the data linking Vioxx to patient deaths from heart failure, so why did they hide such damning evidence from those they were supposed to be protecting?

How involved was the Labour Government in promoting Vioxx? As we detailed earlier, a number of actions have been taken by the Labour Government in order to streamline the process in which drugs can be released onto the market. Instead of writing blank cheques for massive private corporations, the Labour Government should be thinking about their role in this country. The question must surely be: is the UK ruled by large corporations or is it run by a group of people elected by the British Public to protect them? If the latter, then isn't it about time the Government started to do its job and look after the best interests of their people and not a profit-hungry minority?


The Journal of History - Summer 2006 Copyright © 2006 by News Source, Inc.