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UK regulators deny claims that their access to oseltamivir trial data was insufficient

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3966 (Published 18 June 2013) Cite this as: BMJ 2013;346:f3966
  1. Adrian O’Dowd
  1. 1London

The main regulators of drugs in the United Kingdom have denied that they had insufficient access to clinical trial data on the antiviral oseltamivir from its manufacturer, despite concerns about missing data.

Witnesses appearing before the parliamentary Public Accounts Committee said, however, that the current system allowed drug companies to withhold some trial data.

MPs on the committee held an evidence session on 17 June as part of their inquiry into clinical trials and Tamiflu, Roche’s branded form of oseltamivir, which had been used to treat pandemic flu.

The inquiry was prompted by a report published last month by the National Audit Office, which looked at drug regulators’ access to all the clinical trial evidence when licensing oseltamivir and whether the Department of Health for England stockpiled the drug on the basis of clinical evidence.1

Between 2006-07 and 2012-13 the department bought nearly 40 million units of oseltamivir, costing £424m (€495m; $665m). But only 2.4 million units were consumed, mostly during the flu pandemic in 2009-10, and over the same period 10 million units were written off, many because of poor records about their storage environment during the pandemic.

MPs asked witnesses how satisfied they were with the completeness and transparency of access to data from Roche on oseltamivir.

Kent Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency, giving evidence, said, “I am confident that we had access to all the relevant data because there is legal force to require that.

“If a company were not to provide us with all the data, then we have enforcement powers to insist on it. Any information that bears on the efficacy and safety of that product has to be made available to the regulator in order to support a market authorisation.”

Accused of not asking for everything from drug companies, Woods said that the agency insisted on very detailed clinical study reports in summary form, without the raw data.

“If we were not satisfied with the analytical approach that the company had taken, we could go back to the level of the raw data and do it again, but it’s not something that we routinely do,” he said.

Asked about the government’s stockpiles of oseltamivir, Una O’Brien, permanent secretary at the health department, also giving evidence, said, “The risk of pandemic influenza is the number one risk on the government’s national risk assessment for civil emergencies—ahead of coastal flooding and major terrorist incidents.

“It is a matter that is taken profoundly seriously within the department. We have to balance our judgments about the scientific evidence and the value for money in the context of the scale of the risk and uncertainty that we are planning for.”

MPs questioned this commitment, given that millions of units had to be written off because of poor record keeping. O’Brien replied, “We have learnt that lesson.”

Earlier in the session Ben Goldacre, author of Bad Pharma and Wellcome research fellow in epidemiology at the London School of Hygiene and Tropical Medicine, told MPs that the current system was “broken.”

Asked whether problems in the system were wider than those seen with oseltamivir, Goldacre agreed, saying, “Tamiflu is just one small microcosm, and one of the things that is very striking about Tamiflu is that at no stage did Roche break the law, and I think that is because the law is broken.

“Our best available estimate right now shows that half of all the trials that have been conducted and completed for the medicines that we use today have not gone on to be published, and, worse than that, trials with positive results are twice as likely to be published as trials with negative results.”

Fiona Godlee, editor in chief at the BMJ, also giving evidence, said, “Historically, over a period of time, what you have is a situation where research has been put to use for marketing purposes rather than for science.

“The pharmaceutical industry we know—who could blame them—are there to create value for their shareholders, and [they] publish more positive results about their trials than they do negative results.”

Asked why the government had spent around £424m of taxpayers’ money on oseltamivir, Godlee said, “I think it was politically expedient. There was an outbreak of potentially serious influenza, and there was a WHO [World Health Organization] recommendation that countries should do this. The UK wanted to have something.” It was a case of “bread and circuses” to calm the populace, she said.

Godlee added, “Tamiflu, as far as I am aware, has only ever been compared with placebo. It hasn’t ever been compared in a direct comparison with, for example, paracetamol or indeed a stiff whisky or something similar. We are left with some doubt about its effectiveness in prevention.”

Richard Bacon, Conservative MP for South Norfolk, who was chairing the committee in the absence of Margaret Hodge, remarked that the government could have bought an awful lot of whisky for £424m.

The committee said that Roche had initially agreed to appear in the evidence session but had pulled out last week.

Notes

Cite this as: BMJ 2013;346:f3966

Footnotes

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