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Roche medical director could face GMC if the company withheld relevant data on oseltamivir

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8408 (Published 11 December 2012) Cite this as: BMJ 2012;345:e8408
  1. Zosia Kmietowicz
  1. 1BMJ

The chairman of the UK National Institute for Health and Clinical Excellence has said that if Roche were found to have withheld relevant data on its drug oseltamivir (Tamiflu) the company’s medical director at the time of the submission to NICE could be reported to the General Medical Council.

Michael 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.” The request was the latest move in the BMJ’s open data campaign (bmj.com/tamiflu), which aims to persuade Roche to honour the promise it made almost three years ago to make key trial data on oseltamivir available for independent scrutiny.

In her letter Godlee said that she was perplexed that NICE did not require all clinical trial data when it was deciding whether a drug should be purchased by the NHS.1

“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 that it assessed NICE was “colluding with the status quo.”

Godlee pointed out that although Roche could claim in Europe that oseltamivir reduced the rate of complications, such as bronchitis and pneumonia, it could not do so in the United States 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 flu season coming up “the NHS will again be spending millions of pounds on a drug for which the evidence base is almost entirely hidden from public view,” wrote Godlee.

Rawlins said that he was making further inquiries about NICE’s appraisal of oseltamivir. But for the time being, he said, “It would 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.”2

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.” In this case the marketing authorisation holder is the European Medicines Agency.

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.”

Cochrane Collaboration researchers have said that at least 123 trials on oseltamivir were unpublished. They needed Roche to release the data from these trials because the company had not supplied them to the European Medicines Agency.3

Tom Jefferson, an independent epidemiologist with the Cochrane Collaboration and the first author of the Cochrane review of neuraminidase inhibitors for preventing and treating flu,4 has written to the European Medicines Agency asking it to request the missing data from Roche so that he and his team could carry out “in-depth analyses.”5

In a statement the company said, “Roche has provided the relevant information pertinent to the Tamiflu appraisal as per NICE’s requirements, and we follow their processes. We agree with Sir Michael Rawlins’ comment that ‘The arrangements for the submission of confidential information are laid out in our process documents. We expect individual companies to follow these guidelines and we spend a significant amount of time instructing companies to minimise the amount of information marked as confidential.’”

Notes

Cite this as: BMJ 2012;345:e8408

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