The More You Dig , The More Dirt You Get - a follow up to the Vioxx scandal

Following our article: “With Friends Like these, Who Needs Enemies?” which covered the scandal behind the marketing of Merck Inc’s painkilling drug Vioxx, SPEAK dug further to take a look at some of the key figures and institutions behind the scandal. Our investigation has thrown up some interesting facts and unsurprisingly, as we pointed out in the above article, Oxford University are at the very centre of the controversy surrounding the marketing and clinical trials of Vioxx, estimated to have killed in the region of 2000 people in the UK.

This strong link suggests that the University and some of its professors are directly responsible for the death of many of those 2000 individuals. But more worrying still is that, far from being deterred by these deaths, Oxford University has now found a way of bypassing the UK legal system and exporting its drug trials to India, where they can expect the potentially adverse affects from drug trials to go unnoticed!

Oxford University’s world status ranks amongst the highest in the hierarchy of academic institutions, yet its status of academic excellence must surely be thrown into question if the making of a quick buck is paramount, and their involvement in the Vioxx scandal illustrates this fact better than any other.

In 1999, Merck announced that they had produced Vioxx, a painkiller that was as effective as anything else on the market but which did not have the potentially fatal side effects of other "non-steroidal anti-inflammatories" or NSAIDs, such as naproxen and ibuprofen. The company also claimed in Vioxx’s early marketing days that the drug could relieve arthritis and cure colon cancer.

The "Vigor" drug trial, set up in the US in order to test whether Vioxx could be used to treat rheumatoid arthritis showed up some worrying anomalies. 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 Food and Drug Administration (FDA) with data on fatalities from 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 – based on the link to heart attacks flagged up as early as November 1999 - was made known to other regulators around the world.

In the UK, the key clinical trial of Vioxx (called "Victor"), began in 2000, and was principally organised by two senior professors, Dr Michael Langman, a painkiller expert and former dean of Birmingham University's medical school, and Professor D K, now a leading professor at Oxford University whom we are unable to name due to the legal restrictions placed on us.

At the time, Professor D K, was Clinical Director at the CRC Institute for Cancer Studies, University of Birmingham, and was appointed to his present position at Oxford University on 1st October 2001. However, it also appears that Professor D K, was not only the senior figure who set up the “Victor” trial in the UK, but also the leading investigator, and that further, the Institution that was assigned the responsibility of organising the trial in the UK, was none other than Oxford University. It appears he was rewarded for putting this work Oxford University’s way by being appointed to a plum position within the university.

However the intrigue doesn't end there. D K is a leading figure in the Labour Party health circles and a very close friend of Alan Milburn, who was health secretary at the time of the trial.

So, just a quick recap so far as to where we are in a tale of nepotism, duplicity and corruption.

Firstly we have a drug touted by the manufactures as being a wonder drug, not only as an effective painkiller without the side affects of other similar painkillers on the market but a drug that Merck, its producer, claimed could alleviate the symptoms of arthritis and cure colon cancer. Drug trials in the US recorded that the drug had caused fatalities in patients taking the drug. A leading exponent of the drug Prof. D K organised clinical trials in the UK to be carried out by Oxford University, who were paid for their services by a private drug company – Merck – and Professor D K was subsequently awarded a top job at the university. Following the story so far?

So, here we have a drug that is clearly killing people - reports from the FDA detail this. However this didn't stop Merck commissioning Oxford University to undertake trials of the drug in this country. At this point one might have expected Oxford University to be wary of giving the drug to patients as they must have been aware of the FDA reports. One would assume that Oxford University would have informed patients involved in the trial as to the conclusions of the FDA. The fact of the matter is, they did not. Instead, patients involved in the trial were told by the University that the worst they could expect was "tummy pain, dizziness, fluid retention leading to ankle swelling, increase in blood pressure, indigestion and heartburn, mild headache, itching". 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 as part of Oxford University “Victor” trial and more importantly, why weren't they informed of the possible lethal consequences of taking the drug?

So what has Oxford University’s response been to this? Well it might not surprise people to learn that the university has said that the full results from the “Victor” trial won’t be ready until 2008. So why so long? Perhaps they hope that by 2008, the scandal and those implicated in it will have been forgotten, though presumably far from gone. This seems likely, given that just this week, Professor D K was once again in the media spotlight. Apparently, far from learning from their relationship with bedfellows Merck, Oxford University have now done a deal with GlaxoSmithKline, another pharmaceutical company, to develop experimental cancer drugs in India. And who should be leading this initiative but none other than Professor D K himself!

Perhaps Oxford University have learnt their lesson from the “Victor” trial and the negative publicity surrounding it; a lesson in how to cover their backs. So what do they do? Well, they take their shady drug trials to India, a country that is desperate to buy into the potential fiscal rewards of pharmaceutical marketing, as well as to supersede others by taking over as the Pharmaceutical capital of the world – a country where one could argue that the legal ramifications and likely media expose are a lot less severe should their clinical trial go horribly wrong as in the case of “Victor”. After all, the misfortunes of the third world poor are far less likely to raise a stir than in the wealthy west. It seems that the “Victors” in this whole sorry episode are the Pharmaceutical giants, Oxford University and Professor D K. The thousands of victims that died as a result of being administered Vioxx are just another statistic in the endless drive for ever-greater profits. So what’s new?