The British Medical Journal ( BMJ) has alleged that pharmaceutical giant Roche is deliberately hiding clinical trial data about the efficacy of oseltamivir ( Tamiflu) in patients with influenza. The journal says global stockpiling and routine use of the drug are not supported by solid evidence and alleges that Roche concealed neurological and psychiatric adverse events associated with the neuraminidase inhibitor drug.

Influenza en México

In an open letter from Fiona Godlee, MD, editor-in-chief of BMJ, to Professor John Bell, FRS, HonFREng, PMedSci, Regius Professor of Medicine at Oxford University in the United Kingdom and a Roche board member, published online October 29, Dr. Godlee reminds Bell of concerns that were initially voiced in 2009 about the reliability of Tamiflu research.

At that time, BMJ published an updated Cochrane review of neuraminidase inhibitors in healthy adults. That study “took the view that, since eight of the 10

[randomized controlled trials] on which effectiveness claims were based, were never published, and because the only two that had been published were funded by Roche and authored by Roche employees and Roche-paid external experts, the evidence could not be relied upon,” Dr. Godlee writes.

Roche promised to make complete clinical trial data available, but Cochrane researchers and BMJ claim the company has not done so. In her letter to Roche, Dr. Godlee explained that each clinical trial report typically consists of 5 modules, but only module 1 has been provided for each trial.

“What Has Roche Got to Hide?”

In January 2012, the Cochrane Library published an updated review that included unpublished data and revealed inconsistencies and incomplete data. In her open letter to Roche, Dr. Godlee explained, “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123 trials of Tamiflu and that the majority (60%) of patient data from Roche Phase 3 completed treatment trials remain unpublished. There are concerns on a number of fronts: the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects. Meanwhile, Tamiflu has just been added to the list of essential drugs alongside aspirin and beta blockers.”

In an editorial published online October 29 in BMJ, Dr. Godlee asks, “What has Roche got to hide?”

Open Data Campaign

Hoping to prevent similar issues in the future, BMJ is instituting a new policy requiring pharmaceutical companies that sponsor clinical trials to commit to making relevant anonymized patient-level data available to physicians, scientists, and others who reasonably request it as a precondition for publication.

“We will require authors of trials of drugs and devices to commit to making their data available on reasonable request,” said Dr. Godlee in an email interview with Medscape Medical News. “We cannot police this ourselves, but we will encourage researchers whose requests for access are declined to send rapid responses to the BMJ saying what they asked for and why it was declined. We will then ask the authors to account for their decision not to release the data,” Dr. Godlee explained.

“This is part of a journey and by no means the last step on the road. I expect that our next step, when data deposition systems are better developed and accepted, will be to ask authors to deposit their data on submission of their article,” Dr. Godlee said. “[W]e will want to extend this to trials in other areas and to other types of study design. We also hope that other journals will move in the same direction,” Dr. Godlee added.

“I hope very much that the BMJ‘s campaign will succeed in making the full data on oseltamivir available to the Cochrane reviewers, so they can give governments around the world the true picture of this drug’s effectiveness and safety,” Dr. Godlee said.

“Regulators, research ethics committees, and bodies like [the National Institute for Health and Clinical Excellence] who decide which drugs will be bought by governments or reimbursed by health insurers also have a key role in pushing for access and independent scrutiny of the data,” Dr. Godlee explained.

Dr. Godlee has disclosed no relevant financial relationships.

BMJ. Published online October 29, 2012


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