Vioxx

‘The scale of the Vioxx case outstrips the Thalidomide scandal that led to the 1968 Medicines Act governing the way in which drugs are regulated. The MHRA which approves drugs in the UK, has launched an investigation into whether Merck deliberately withheld information on Vioxx when it applied for a British license in 1999….This case highlights the way pharmaceutical companies can distort scientific data on a product to exaggerate its benefits.’

Vioxx was considered a breakthrough in pain relief for arthritis sufferers as it did not have the same side effects as other drugs. It was classed as one of a new class of anti-inflammatory drugs called COX-2 inhibitors that were not only more effective than traditional painkillers, but had the added bonus of reducing the risk of ulcers and gastric problems. Merck was competing against Pfizer to bring this product to market as the first of its kind and it is alleged that in its haste for profits, it failed to tell its regulators – the FDA in America and MHRA in the UK – about known risks. Merck apparently knew Vioxx was killing Alzheimer’s patients, but hid this fact from the agencies for years.

One of Merck’s chief researchers, Nancy Santanello, has admitted the company’s research unit had raised concerns as early as 1998 over the increased risk of heart attacks and strokes, but this data had been suppressed. Merck denies accusations of negligence and claims that it only realised there was a problem with the drug when research showed that its use could significantly increase heart attacks and strokes if taken for 18 months.

A member of the MHRA says in Merck’s defence: ‘The adverse reaction with Vioxx only became evident after 18 months and the risk was an increased cardiovascular event. This was a slight risk, but a real risk. It wasn’t showing up if a patient had taken the drug for less than 18 months though, so there is a very fine balance. You have the experts, the scientific experts as employees of the MHRA and those employed on commissions to advise on the work of the MHRA and they only take decisions based on information they receive.' He raised the point that if information is suppressed, there is very little the regulator can do. However, when the regulators became aware of the situation with Vioxx, they neglected to pull the drug from the market. As a result, more than 20 million people worldwide, including 400,000 patients in the UK took Vioxx before Merck withdrew the drug in September 2004.

The focus then turned to the regulator’s role. In America in particular, the FDA was accused of withholding information much like Merck had done. David Graham from the FDA’s Office of Drug Safety testified before Congress and declared that the agency had also hidden negative data on Vioxx. ‘He described a broken system for following up on the safety of drugs once on the market that he says is a direct result of the regulator being too cosy with the pharmaceuticals industry.’

The fact that a member of the FDA openly admits that there is an intimate relationship between the regulator and the industry suggests that there is friction between different departments within the FDA. When Graham and his team concluded the study on Vioxx for example, the Office of New Drugs allegedly pressured him to change his conclusions and recommendations and told him he would not be allowed to present his findings if he did not do as he was told. The FDA demanded that he tampered with figures estimating that users of the drug had suffered at least 38,000 excess heart attacks and sudden cardiac deaths. Graham also received an internal email from the FDA stating that the regulator was ‘not contemplating’ a warning against the use of high-dose Vioxx.

The MHRA licensed Vioxx in the UK in 1999. Five years later when Vioxx was withdrawn by Merck, the EMEA decided to carry out a safety review and the MHRA was investigated by the Health Committee in the House of Commons. In its report, regulatory failure was partially blamed on the regulator’s commitment to serving the industry rather than the public.