Navigation Links
Release all Tamiflu data as promised, argue researchers
Date:11/26/2012

The latest correspondence is posted online today as part of the BMJ's open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key Tamiflu trial data available for independent scrutiny.

Last week, Donald MacLean, Life Cycle Leader for Tamiflu, wrote to Professor Chris Del Mar in his capacity as coordinating editor of the Cochrane Acute Respiratory Infections Group, concerning "our debate on Tamiflu data."

The Cochrane researchers say they object to Roche's suggestion that there is a debate on Tamiflu data. "There is no debate nor can there be any debate about the data whilst you do not honour your promise," they say. "The only reason we keep asking Roche to keep its promise, rather than simply getting the data from the European Medicines Agency directly, is because Roche has not supplied all of the data to the European regulator."

Roche's letter also mentions "disagreements" over the type of analyses the Cochrane team wish to do, but the researchers point out that their methods and analyses have been public for nearly two years and "follow Cochrane procedure" and state that they are not aware of any specific concerns from Roche.

Roche's letter goes on to say that, in order to reach "an amicable resolution" Roche plans to set up "a multi-party advisory board to review the totality of Tamiflu data" . which they believe is "a sensible, fair and transparent way of addressing this public debate."

But the Cochrane team argue that Roche's offer is merely a belated attempt at turning the clock back, and call on the company to expand its data sharing pledges "to become compatible with current regulatory norms."

They say: "The European Medicines Agency and the EU Ombudsman have made abundantly clear that there is no reason for anonymised clinical data to be withheld from public scrutiny once a marketing authorisation has been obtained for a pharmaceutical. Why should Roche not - at the minimum - meet this standard?"

In summary, they say, "we ask to you to honour your promise of three years ago and make public full clinical study reports in your possession."


'/>"/>

Contact: Emma Dickinson
edickinson@bmjgroup.com
44-020-738-36529
BMJ-British Medical Journal
Source:Eurekalert

Related medicine news :

1. Catch and release
2. CSHL Press releases new book on the biology of drug addiction
3. Institute for Population Health Improvement releases buyers guide for health information exchange
4. Premier global health journal, The Lancet, releases series on universal health coverage
5. Evidence that new biomimetic controlled-release capsules may help in gum disease
6. PMIC Announces Release of New CDT 2013 Dental Procedure Coding System
7. Muscular Development Store Releases the Optimum Performance Workout for High Intensity Training
8. MTSS-mba Membership Benefits Administration Software for Private and Taft-Hartley Employee Benefit Funds Releases New Pension Modules
9. Candeo Partners with Catholic Church Organization to Release New Sexual Addiction Recovery Program
10. GMC Denali Road Bike Review Released Today By GMCDenaliRoadBike.net
11. Waterpik Water Flosser Reviews Released Today By WaterpikReviews.net
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2017)... ... May 21, 2017 , ... ... together a cross-disciplinary group of scholars, policymakers, and activists wanting to address equity ... Equity is the third book from a recent series of from this ...
(Date:5/21/2017)... ... May 21, 2017 , ... Dental visits are ... months since you've seen a dentist, it's time for a dental checkup. The ... once per year. , Dental checkups are a relatively easy procedure that involves ...
(Date:5/19/2017)... City, Mo (PRWEB) , ... May 19, 2017 , ... ... Saturday, May 20, his name will already appear on two major research studies that ... has been working with Dr. Matt Daggett, KCU alumnus and an orthopedic surgeon, alongside ...
(Date:5/19/2017)... ... May 19, 2017 , ... ... class of Beckman Young Investigators: , Victor Acosta, Ph.D. - University of New ... Dan Fu, Ph.D. - University of Washington, Erik Grumstrup, Ph.D. - Montana Stata ...
(Date:5/19/2017)... ... May 18, 2017 , ... CloSYS products which are marketed ... while extremely helpful for mouth and gum health, which is linked to one’s overall ... customers learned quickly of the powerful ways in which CloSYS products immediately helped eliminate ...
Breaking Medicine News(10 mins):
(Date:5/18/2017)...  Two Bayer U.S. Pharmaceutical leaders received top awards ... 28 th Woman of the Year ... longstanding mission of furthering the advancement and impact of ... Cindy Powell-Steffen , senior director of brand activation and ... Libby Howe , a regional business manager for New ...
(Date:5/12/2017)... and Canada joint tech company Laughing Face has ... detergent, and features a powerful disinfection process. The company ... washes and sanitizes women,s panties or babies, cloth diapers in 25 ... ... an external water inlet. ...
(Date:5/10/2017)... , May 10, 2017  The Corporate ... or employees of sleep therapy clinics to call ... sleep therapy clinic is involved in a substantial ... interested in hearing from an employee of a ... in a kickback scheme to provide medical practice groups ...
Breaking Medicine Technology: