UK regulator investigates Merck's handling of Vioxx trial data

By Nick Smith

LONDON (Agence de Presse Medicale for Reuters Health) - Merck is under investigation by the UK's Medicines and Healthcare Products Regulatory Agency over its handling of Vioxx (rofecoxib) trial data, the company said on Tuesday.

A spokeswoman for MSD UK told APM the MHRA had not revealed what it was looking for but had requested "very wide ranging documentation'' connected with the APPROVe (adenomatous polyp prevention on Vioxx) trial of rofecoxib 25 mg in colon cancer.

It was the preliminary results of this 3-year cancer prevention trial involving 2,600 patients with a history of colorectal adenomas that triggered the worldwide withdrawal of Vioxx on September 30 last year.

According to Merck, the trial's external safety board noticed that the drug might be associated with a higher than normal incidence of heart attacks and strokes after 18 months' use but this difference did not become statistically significant until month 34 -- one week before the drug was withdrawn.

The company spokeswoman said: "We are subject to an investigation in connection with Vioxx and we are co-operating fully with that. The information requested is to do with the communication (of information) surrounding the trial."

"The MHRA has not made accusations or suggested anything specific. The investigation is ongoing and it is rather difficult to comment when we don't know what it is looking for.''

A spokeswoman for the MRHA declined to say what it was looking for or when its investigation was likely to be completed.

In a statement on Vioxx last week, the MHRA said unlimited fines and up to 2 years' imprisonment could be imposed if a company failed to provide information relevant to the evaluation of the risks and benefits of a product.

It added: "The MHRA is investigating whether medicines' legislation was breached by Merck, Sharp and Dohme PLC in connection with Vioxx."