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:5/27/2016)... ... 27, 2016 , ... An educational campaign aimed at everyone ... courtesy of awareness-driven celebrities and thought leaders. It also provides insight to the ... leaders such as Bioness. , As patients feel increasingly concerned about the ...
(Date:5/27/2016)... , ... May 27, 2016 , ... ... scholarships to students studying complementary medicine. Allison Outerbridge is this year’s Life ... award on May 18 at the university’s Student Leadership Awards ceremony. , Outerbridge ...
(Date:5/26/2016)... ... May 26, 2016 , ... Cabot Corporation, ... defective respirators, according to court documents and SEC filings. A jury has ... Tyler v. American Optical Corporation, Case No. BC588866, Los Angeles County, California. The ...
(Date:5/26/2016)... ... 2016 , ... The Woodlands at John Knox Village , Florida’s first ... for living and healing, celebrated its grand opening, today. The Woodlands at John Knox ... by Empowered Staff. , “This is an incredibly fulfilling time for John Knox Village ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel will ... Long Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public ... Retina Group of New York , is a Board Certified ophthalmologist who ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 24, 2016 ARANZ Medical  Ltd ... healthcare sector, has been named the Coretex Hi-Tech Emerging Company ... Dr Bruce Davey , CEO of ARANZ ...  It,s really good to be recognised for the work we ... are used in 35 countries around the world from Sub-Saharan ...
(Date:5/24/2016)... BioMarketing as senior vice president of sales, announced Andrea Heslin Smiley , VMS ... company,s business development and sales team, exploring new opportunities for VMS to empower patients ... ... ... ...
(Date:5/24/2016)... May 24, 2016 ... , la première endoprothèse à double ... à l,intervention portant sur les membres inférieurs ... OrbusNeich, entreprise mondiale spécialisée dans la ... la vie, a élargi son portefeuille pour ...
Breaking Medicine Technology: