BMJ editor urges Roche to fulfil promise to release Tamiflu trial data

October 30, 2012, British Medical Journal

In an open letter to company director, Professor Sir John Bell, she says: "Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny."

The letter is published on the BMJ's website (bmj.com/tamiflu ) alongside correspondence by the Cochrane team with Roche, the US Centres for Disease Control (CDC) and the (WHO), as part of an open data campaign aimed at persuading Roche to give doctors and patients access to the full data on Tamiflu.

Dr Godlee's letter follows recent reports that the European Medicines Agency (EMA) has initiated infringement proceedings against Roche to investigate deficiencies in safety reporting, including the processing of around 80,000 reports on suspected .

Dr Godlee is also one of 28 signaturies to a letter published in The Times today (thetimes.co.uk/letters) calling on drug companies to "come clean" and make clinical trial data for all drugs in current use available to healthcare professionals.

Pressure from politicians is also mounting. Last week, Sarah Wollaston, a GP and Conservative MP, raised the issue of missing data in Parliament, while Health Minister Norman Lamb has agreed to meet experts to discuss the issue of access to clinical trial data.

In December 2009, Roche made a public promise to release full clinical trial reports of its (Tamiflu) in response to a major investigation by the BMJ and researchers Peter Doshi and Tom Jefferson from the Cochrane Collaboration.

The investigation found no clear evidence that Tamiflu prevents complications like pneumonia in healthy people. It also raised serious concerns about access to drug data, the use of ghost writers in drug trials, and the drug approval process.

Since the investigation, some further data have been released to the Cochrane reviewers, but the full data set has still not been provided.

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123 trials of Tamiflu and that the majority (60%) of patient data from Roche Phase 3 completed treatment trials remain unpublished.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."

Meanwhile, has been a great commercial success for Roche and has been added to the World Health Organisation's list of essential medicines.

In her letter, Dr Godlee appeals to Professor Bell "to bring your influence to bear on your colleagues on Roche's board." She adds: "In refusing to release these data of enormous public interest, you put Roche outside the circle of responsible pharmaceutical companies. Releasing the data would do a great deal to restore confidence in your company and its board of directors."

In a response not for publication, Professor Bell said he has referred the matter to Roche and is awaiting a response.

"The open correspondence on bmj.com aims to hold specific individuals and organisations to account," writes Dr Godlee in an accompanying editorial. "Their actions are preventing independent scrutiny of the results of and putting patients' lives at risk. We also hope it will contribute to a sea change in the public mood."

A poll on bmj.com last week asked: "Who is mainly at fault for denying access to negative clinical trial results?" Of the 569 votes, 69% said pharma, 13.5% said regulators, and 9% said legislators.

The BMJ plans to launch other campaigns linked to its investigations in the future.

Explore further: Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data

Related Stories

Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data

January 18, 2012
Two years after pharmaceutical giant Roche promised the BMJ it would release key Tamiflu trial data for independent scrutiny, the safety and effectiveness of this anti-influenza drug remains uncertain, warn experts today.

Roche probed over faulty drug-safety reporting

June 21, 2012
Swiss pharmaceutical giant Roche is under investigation over a failure to properly report adverse drug side-effects, the European Medicines Agency (EMA) said on Thursday.

Roche probed for not reporting side effects

October 23, 2012
(AP)—Europe's top drug regulator announced Tuesday it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs being used by U.S. patients.

Tamiflu: Full reports from trials should be public; regulators respond to recommendations

April 10, 2012
The full clinical study reports of drugs that have been authorized for use in patients should be made publicly available in order to allow independent re-analysis of the benefits and risks of such drugs, according to leading ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.