Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (NICE), has said that if Roche is found to have withheld relevant data on its drug oseltamivir (Tamiflu) the company’s medical director will be reported to the General Medical Council (GMC).
Rawlins was responding to a letter from the BMJ’s editor in chief, Fiona Godlee, in which she asked NICE to withdraw its guidance on oseltamivir until it “has received and reviewed the full clinical trial data.”
Dr Godlee’s letter is available at bmj.com/tamiflu as part of the BMJ’s open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key trial data on oseltamivir available for independent assessment.
Since then, the BMJ has been trying to help the Cochrane Collaboration gain full access to the data.
In her letter Godlee said she was perplexed that NICE does not require all clinical trial data when it is deciding if a drug should be purchased by the NHS. “It is my understanding that NICE can ask for additional information from a company but in the case of Tamiflu you did not do so,” she wrote.
She concluded that by not demanding all research findings on the drugs it assesses “NICE is colluding with the status quo by failing to take a harder line.”
Godlee pointed out that while Roche can claim in Europe that oseltamivir reduces the rate of complications, such as bronchitis and pneumonia, it cannot do so in the US because the US Food and Drug Administration “performed a more thorough assessment of the trial data and found no good evidence of an effect on rates of complications.
”With the influenza season soon coming up “the NHS will again be spending millions of pounds on a drug for which the evidence base if almost entirely hidden from public view,” wrote Godlee.
Rawlins said he is making further enquiries about the NICE’s appraisal of oseltamivir. But for the time being he said, “It would be inappropriate for NICE to withdraw its guidance on amantadine, oseltamivir and zanamivir for the treatment of influenza. The additional clinical trial data might, for example, support the use of oseltamivir under the circumstance we have already proposed. In that case, patients would be damaged by precipitate withdrawal of our guidance.”
He maintained that NICE requires “full access to all the information that is available to marketing authorisation holders of medicines when they are subject to a NICE technology appraisal.”
The authorisation holders in this case are the European Medicines Agency (EMA).
He added, “The medical director of the company involved in making an evidence submission to NICE, is asked to sign a declaration in which he/she confirms ‘that all relevant data pertinent to the technology appraisal has been disclosed to the Institute.’ Pharmaceutical physicians are very well aware of their obligations and if a medical director were knowingly to withhold relevant data the Institute would report the matter to the General Medical Council.”
The Cochrane reviewers now know that there are at least 123 trials of Tamiflu and that the majority (60%) of patient data from Roche Phase 3 completed treatment trials remain unpublished. Their main concerns relate to “the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects” and they need Roche to release these trials because the company has not supplied them to the EMA.