Monthly Archives: October 2012

BMJ: Clinical trial data for all drugs in current use must be available for independent scrutiny

In an impassioned editorial, BMJ editor Fiona Godlee calls on the pharmaceutical industry to release clinical trial data on all approved drugs, and on medical journals to publish industry-funded trials only when there is a commitment to make patient-level data available on reasonable request.  She states that the BMJ will require this commitment for all clinical trials of drugs and devices, whether industry-funded or not, beginning in January 2013.  In addition, BMJ is publishing online all correspondence between Roche and the Cochrane Collaboration researchers regarding the oseltamivir (Tamiflu) data.  More on the battle for Tamiflu data here.

Addendum 11/2/2012:  read Pharmalot’s coverage here.

BMJ editor: Open letter to Roche about oseltamivir trial data

In BMJ:

Roche promised in 2009 to release full reports from clinical trials of oseltamivir in response to an investigation by the BMJ and the Cochrane Collaboration.  In this open letter to John Bell, regius professor of medicine at Oxford University and a Roche board member, the BMJ’s editor in chief further urges the company to disclose the full data.

Read the full letter here.

Background here.

Ben Goldacre on missing data and publication bias

Ben Goldacre at Strata Conference

Here is a video of Ben Goldacre speaking at the Strata Conference in London earlier this month (H/T Chris Southan).

I also recommend his book, Bad Pharma:  How drug companies mislead doctors and harm patients, which goes into detail on how missing data and publication bias distort the medical literature and harm patients.

 

Johns Hopkins to launch Center for Drug Safety and Effectiveness

Johns Hopkins is launching a new Center for Drug Safety and Effectiveness.  Via G. Caleb
Alexander,

On Wednesday, October 24, we will launch the Johns Hopkins Center for Drug Safety and Effectiveness, a collaborative effort of the Bloomberg School of Public Health and Johns Hopkins Medicine.  The Center will fulfill its mission by supporting individuals engaged in research, training, clinical programs and public service to optimize the safe and effective use of prescription medicines in the United States and around the world.
We are delighted that Dr. Mark McClellan will deliver the inaugural lecture for the Center on October 24 at 4:00 PM, with a reception to follow.

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