BMJ: Roche owes more data on Tamiflu

Roche is on the firing line at the British Medical Journal. In a report from the Cochrane Collaboration research group, BMJ says Roche ($RHHBY) hasn't handed over all its data on Tamiflu, calling the flu fighter's efficacy into question. Given the fact that governments worldwide have spent billions to stockpile the drug in case of a pandemic, Roche owes complete transparency in return, BMJ says. "The bottom line is that people need to have access to all the data," investigations editor Deborah Cohen told Bloomberg. "They need to be able to do an independent review."

The brouhaha began when Cochrane researchers set out to vet Roche's claims that Tamiflu could stave off flu complications and cut the number of hospitalizations from the disease, InPharm reports. The data they were able to obtain from European regulators left some questions unanswered, so they appealed to Roche for more data. Cochrane now says that Roche didn't fully respond to that request, and so those questions remain unanswered.

Roche, for its part, says all the trial data on Tamiflu is available, either via published studies or in summary on the Roche website. "We stand behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu," the company said (via Twitter).

The BMJ, meanwhile, is holding up the Tamiflu question as an illustration of ongoing problems with data transparency. "We are still a long way away from having a full trial history for all drugs in clinical use," BMJ Editor-in-Chief Fiona Godlee said (as quoted by InPharm). "Public safety and the proper use of public money demands that we should stop at nothing less than this."

- get the coverage from Bloomberg
- see the InPharm story

Related Articles:
Tamiflu concentration change aids dosing accuracy
Study: No hard evidence that flu vaccine protects the elderly

Suggested Articles

AbbVie and Allergan were already jumping through hoops for their merger before a new tax added hundreds of millions to the cost.

Avastin and Herceptin saw U.S. slowdown that's “not very pronounced” after bioisim launched, but Roche execs still warn of "a significant impact.…

Novo Nordisk, which recently completed a wastewater treatment plant for its massive U.S. API site, has made a gift of the $40 million facility.